TENDE VAV-IW

Radiant Infant Warmer

User and Maintenance Manual

Tende VAV Baby Incubator

User and Maintenance Manual
Rev01/ 11 April 2014
© 2013 Tende Elektronik ve Yazılım Ltd. Şti
All Rights Reserved.

I N F A N T W A R M E R
User Notice

The information in this document aims to present an adequate information source to the user about
the spare part order, maintenance, use and instalment of the given device. For the safety of
user and patient, it is required to follow the instructions in the guide and the device is required
to be operated by appropriately educated skilled medical personnel. The information in this
manual has been confirmed during the editor publication date.

Limited Warranty

Tende guaranties that all of its new equipment are excluded of any material or poor workmanship
deficiencies under the normal operation and service conditions along 2 years starting from the
delivery date. This warranty doesn’t include consumable materials (like sensors, joints, batteries,
hinges, etc...) or the broken parts resulted from misuses.
This warranty includes the maintenance or change of malfunctioning or failure parts within the
warranty period. The warranty doesn’t include the devices which some changes made on without any
written permit by Tende. Seller isn’t responsible for any direct or indirect damages or crushes. This
warranty is no assignable.

Technical Support

The repair of the warranted Tende equipment should be done in authorized Service points. In
case of maintenance, contact to Tende Technical Service Centers. Note the model and serial
number of failed or defective unite before contacting to Tende Technical Service Centers and
make sure that you inform Tende Technical Service for this number.
In the case that you are required to send the equipment, pack it carefully with all accessories to
prevent damages resulted from delivery. Place all equipment parts into the pack. Tende Elektronik
Yazılım Mühendislik İletişim Makine San. ve Tic. Ltd. Şti is not responsible for damages during the
delivery or inappropriate delivery of the equipment.

Contact Information for Customers

Please contact to us via the contact information given below in case of suspecting the safety and
operation of the device or get more information about it.

Tende Elektronik ve Yazılım Ltd. Şti

Hacettepe Ivedik OSB Teknokenti 1368. Cadde No: 61/21 Yenimahalle ANKARA 06378, TURKEY
Phone: +90 312 397 07 33, Fax: +90 312 397 17 87, e-mail: [email protected], web:
www.tende.com.tr
 Table of Contents
Chapter 1 User Responsibility ............................................................................................... 1-1
1.1 Safety Information ............................................................................................................................ 1-1
1.2 Environment ................................................................................................................................... 1-11

Chapter 2 Overview.............................................................................................................. 2-1

2.1 Views of the Infant Radiant Warmer ................................................................................................ 2-1
2.2 Control Panel .................................................................................................................................... 2-7
2.3 External Interface ........................................................................................................................... 2-11
2.3.1 Printer ............................................................................................................................................ 2-11
2.3.2 Cartridge ........................................................................................................................................ 2-13
2.4 Built-in Rechargeable Battery ........................................................................................................ 2-15
2.5 Symbols Used on the Device or in the Manual ............................................................................... 2-17
2.6 Protective Grounding ..................................................................................................................... 2-21
2.7 Equipotential Grounding ................................................................................................................ 2-22

Chapter 3 Pre-operational Check .......................................................................................... 3-1

3.1 Appearance Inspection ..................................................................................................................... 3-1
3.2 Mechanical Check ............................................................................................................................ 3-1
3.3 Controller Check .............................................................................................................................. 3-2

Chapter 4 Installation and Connection................................................................................... 4-1

4.1 Connecting the AC Power Supply ..................................................................................................... 4-1
4.2 Connecting the Sensor ...................................................................................................................... 4-1
4.3 Connecting the Gas Source................................................................................................................ 4-1
4.4 Mounting the Bracket ....................................................................................................................... 4-3
4.5 Using the Built-in Electronic Scale .................................................................................................... 4-4

Chapter 5 Basic Operations .................................................................................................. 5-1

5.1 Device Startup .................................................................................................................................. 5-1
5.2 Operating Steps ................................................................................................................................ 5-1
5.3 Operation of the Pediatric Guard ..................................................................................................... 5-4
5.4 Using the X-ray Tray .......................................................................................................................... 5-4
5.5 Pillar Orbit........................................................................................................................................ 5-5
5.6 Common operation of each parameter module ............................................................................... 5-5
5.6.1 Alarm Printing ................................................................................................................................. 5-5
5.6.2 Alarm switch.................................................................................................................................... 5-6
5.6.3 Alarm upper and lower limit setup .................................................................................................. 5-6
5.6.4 Default Configuration ..................................................................................................................... 5-6
5.6.5 Exchange waveform .........................................................................................................................5-6
5.6.6 Setup the gain .................................................................................................................................. 5-6
5.6.7 Waveform speed .............................................................................................................................. 5-6
5.6.8 Waveform color ............................................................................................................................... 5-7
 5.6.9 Waveform Style ................................................................................................................................5-7
5.7 Device Shutdown ..............................................................................................................................5-7

Chapter 6 Warmer Setup ...................................................................................................... 6-1

6.1 Skin Setup ........................................................................................................................................ 6-1
6.2 Manual Mode Setup /Infant Mode Setup ......................................................................................... 6-1
6.2.1 Manual Mode display ...................................................................................................................... 6-1
6.2.2 Infant Mode display ......................................................................................................................... 6-3
6.2.3 Skin Temperature Alarm example ....................................................................................................6-4
6.3 Operating Mode ............................................................................................................................... 6-5
6.4 LIGHTING SETUP ...............................................................................................................................6-5
6.5 Phototherapy SETUP........................................................................................................................ 6-5
6.5.1 Bilirubin irradiance distribution of the phototherapy lamp ............................................................. 6-6
6.5.2 Effective Light Spot Distribution on the Bassinet Surface ................................................................ 6-7
6.6 WEIGH INFANT ................................................................................................................................. 6-8
6.7 ADJUST BED HEIGHT ....................................................................................................................... 6-10

Chapter 7 Bassinet Tilt........................................................................................................... 7-1

Chapter 8 Apgar Setup .......................................................................................................... 8-1
8.1 Apgar Count Alarm ............................................................................................................................ 8-1
8.2 Apgar Countdown Alarm ................................................................................................................... 8-1

Chapter 9 ECG Monitoring. .................................................................................................... 9-1

9.1 Definition of ECG Monitoring ............................................................................................................ 9-1
9.2 Precautions for ECG Monitoring. ....................................................................................................... 9-1
9.3 Monitoring Steps ............................................................................................................................... 9-2
9.3.1 Preparation ....................................................................................................................................... 9-2
9.3.2 Installing the ECG Lead .................................................................................................................... 9-3
9.4 ECG Screen Hotkeys .......................................................................................................................... 9-4
9.5 ECG Setup ......................................................................................................................................... 9-5
9.5.1 Set Lead Name ................................................................................................................................. 9-5
9.5.2 Set Calculate Lead ........................................................................................................................... 9-5
9.5.3 Setup the HR Source ....................................................................................................................... 9-5
9.5.4 Setup the Filtering Mode ................................................................................................................. 9-5
9.5.5 Set Notch Filter ............................................................................................................................... 9-6
9.5.6 Setup the Gain ................................................................................................................................. 9-6
9.6 ECG self-learn ..................................................................................................................................9-6

Chapter 10 NIBP Monitoring ................................................................................................... 10-1

10.1 Overview.........................................................................................................................................10-1
10.2 NIBP Monitoring ............................................................................................................................ 10-1
10.2.1 NIBP Measurement ...................................................................................................................... 10-1
10.2.2 NIBP measurement method .........................................................................................................10-3
10.2.3 NIBP Display ............................................................................................................................... 10-3
10.2.4 Measurement Limits .................................................................................................................... 10-4
 10.2.5 NIBP Setup .................................................................................................................................. 10-5
10.2.6 Assistance in Venipuncture ..........................................................................................................10-5
10.3 NIBP Reset ..................................................................................................................................... 10-6

Chapter 11 SpO2 Monitoring .................................................................................................... 11-1

11.1 Definition of SpO2 Monitoring ...................................................................................................... 11-1
11.1.1 Measuring Principle of SpO2 Plethysmography Parameter ......................................................... 11-1
11.1.2 Identifying the SpO2 Type ........................................................................................................... 11-1
11.1.3 SpO2 Monitoring ......................................................................................................................... 11-2
11.2 Precautions for SpO2 / Pulse Monitoring ....................................................................................... 11-2
11.3 Monitoring Steps ............................................................................................................................ 11-3
11.4 Measurement Limits ....................................................................................................................... 11-5
11.5 SpO2 Setup ..................................................................................................................................... 11-5
11.5.1 Setup the Signal Indication .......................................................................................................... 11-5
11.5.2 Smart Alarm .................................................................................................................................11-6
11.5.3 Setup the Pulse Sound ................................................................................................................. 11-7
11.5.4 Setup the rapid SpO2 .................................................................................................................... 11-7
11.5.5 Setup the Average Time ............................................................................................................... 11-7
11.5.6 Setup the Calculation Sensitivity................................................................................................. 11-7
11.5.7 NIBP Same Side .......................................................................................................................... 11-8
11.6 Masimo Information ....................................................................................................................... 11-8

Chapter 12 RESP Monitoring .................................................................................................. 12-1

12.1 Generation of Resp ......................................................................................................................... 12-1
12.2 Placement of Electrodes ................................................................................................................. 12-1
12.2.1 Optimization of Lead Position ..................................................................................................... 12-1
12.2.2 Placing Electrodes for RESP Measurement ................................................................................ 12-2
12.3 RESP Setup ..................................................................................................................................... 12-2
12.3.1 Resp Lead .................................................................................................................................... 12-2
12.3.2 Resp Filter. ...................................................................................................................................12-3
12.3.3 Setup the Gain ............................................................................................................................ 12-3
12.3.4 APNEA ALM Delay ........................................................................................................................ 12-3
12.4 Maintenance and Cleaning ............................................................................................................ 12-3
12.5 Apnea Detection ............................................................................................................................ 12-4
12.6 Connecting the Apnea Wakeup Device.......................................................................................... 12-4
12.7 Apnea Setup .................................................................................................................................. 12-5
12.8 Precautions and Procedure ........................................................................................................... 12-5

Chapter 13 CO2 Monitoring ................................................................................................. 13-1

13.1 Overview........................................................................................................................................ 13-1

13.2 CO2 Module ................................................................................................................................... 13-2
13.3 CO2 Sensor Connection .................................................................................................................. 13-2
13.4 Measurement Steps for Respironics Mainstream and Sidestream Analyzer ................................. 13-4
 13.5 Measurement Steps for Masimo Mainstream and Sidestream Analyzer ...................................... 13-6
13.5.1 Measurement Steps .................................................................................................................... 13-6
13.5.2 Checks before Use....................................................................................................................... 13-7
13.6 CO2 Setup ....................................................................................................................................... 13-8
13.6.1 Work Mode ................................................................................................................................. 13-8
13.6.2 Pressure Unit............................................................................................................................... 13-8
13.6.3 Gas Compensation ...................................................................................................................... 13-8
13.6.4 Apnea Alarm Delay ...................................................................................................................... 13-8
13.6.5 Altitude........................................................................................................................................ 13-9
13.6.6 Balance Gas ................................................................................................................................. 13-9
13.6.7 Waveform Scale .......................................................................................................................... 13-9
13.7 Maintenance and Cleaning of Respironics Mainstream and Sidestream CO2 Sensor .................... 13-9
13.7.1 General Cleaning ......................................................................................................................... 13-9
13.7.2 Clean the Reusable Airway Adapter of Mainstream Sensor........................................................ 13-9
13.7.3 Disinfection of Reusable Airway Adapter .................................................................................... 13-9
13.7.4 Disinfection Frequency of Reusable Airway Adapter ................................................................ 13-10
13.7.5 Zeroing ...................................................................................................................................... 13-10
13.8 Masimo Mainstream and Sidestream Module Related Information ........................................... 13-10
13.8.1 Zeroing ...................................................................................................................................... 13-10
13.8.2 Adverse Effects on Performance ............................................................................................... 13-11
13.8.3 Safety Alarm Information .......................................................................................................... 13-13
13.8.4 Airway Obstruction ................................................................................................................... 13-15
13.8.5 Discharging Waste Gases .......................................................................................................... 13-15
13.8.6 Leakage Check........................................................................................................................... 13-15
13.8.7 Safety Symbols .......................................................................................................................... 13-16
13.8.8 Patents and Trademarks ........................................................................................................... 13-17

13.8.9 Consumables ............................................................................................................................. 13-17

13.8.10 Maintenance ........................................................................................................................... 13-18
13.8.11 Cleaning the Analyzer .............................................................................................................. 13-19

Chapter 14 Information Review .......................................................................................... 14-1

14.1 Trend Graph Review ...................................................................................................................... 14-1

14.2 Trend Chart Review ....................................................................................................................... 14-2
14.3 NIBP Measurement Review ........................................................................................................... 14-4
14.4 Alarm Event Review ....................................................................................................................... 14-4
14.5 Wave holographic review .............................................................................................................. 14-5

Chapter 15 Alarm Setup ...................................................................................................... 15-1

 15.1 Overview........................................................................................................................................ 15-1
15.1.1 Alarm Type .................................................................................................................................. 15-1
15.1.2 Alarm Level .................................................................................................................................. 15-2
15.2 Type of Alarm................................................................................................................................. 15-2
15.2.1 Light Alarm .................................................................................................................................. 15-2
15.2.2 Audible Alarm .............................................................................................................................. 15-2
15.2.3 Alarm Information ....................................................................................................................... 15-3
15.2.4 Alarm Parameter Flashing ........................................................................................................... 15-3
15.2.5 Alarm Status Icon ........................................................................................................................ 15-3
15.2.6 Alarm Delay ................................................................................................................................. 15-3
15.3 Alarm Setup ................................................................................................................................... 15-3
15.4 Audio Paused ................................................................................................................................. 15-4
15.4.1 Setup the Audio Paused .............................................................................................................. 15-4
15.4.2 Canceling the Audio Paused ........................................................................................................ 15-5
15.5 Detection Alarm System ................................................................................................................ 15-5
15.6 Alarm Response ............................................................................................................................. 15-5
15.7 Alarm System ................................................................................................................................. 15-6

Chapter 16 System Setup .................................................................................................... 16-1

16.1 Main Menu .................................................................................................................................... 16-1

16.2 Option Setup.................................................................................................................................. 16-1
16.2.1 Hearbeat Volume ........................................................................................................................ 16-2
16.2.2 Key Volume ................................................................................................................................. 16-2
16.2.3 LCD Brightness ............................................................................................................................ 16-2
16.2.4 Automatic LCD Brightness ........................................................................................................... 16-2
16.3 Device Setup .................................................................................................................................. 16-2
16.3.1 System Datatime setup ............................................................................................................... 16-2
16.3.2 Module Switch Setup .................................................................................................................. 16-3
16.3.3 Apnea Monitoring Switch............................................................................................................ 16-3
16.3.4 Print Setup .................................................................................................................................. 16-3
16.4 Device Information ........................................................................................................................ 16-3
16.5 Device Maintenance ...................................................................................................................... 16-4
16.5.1 NIBP Calibration .......................................................................................................................... 16-6
16.5.2 NIBP Leak Detection .................................................................................................................... 16-7
16.5.3 ECG Calibration ........................................................................................................................... 16-7
16.6 Demo Mode ................................................................................................................................... 16-8

Chapter 17 Resuscitation System ........................................................................................ 17-1

 17.1 Operation Panel ............................................................................................................................. 17-1
17.2 Pre-operational Check of the Resuscitation System ...................................................................... 17-3
17.3 Accessory Installation .................................................................................................................... 17-3
17.3.1 Vacuum Stage ............................................................................................................................. 17-3
17.3.2 Resuscitation Stage ..................................................................................................................... 17-5
17.3.3 Oxygen Therapy Phase ................................................................................................................ 17-5
17.4 Alarm ............................................................................................................................................. 17-6
17.5 Device Startup ............................................................................................................................... 17-6
17.6 Vacuum Suction System ................................................................................................................ 17-6
17.7 Resuscitation Setup, Checking and Use ......................................................................................... 17-7
17.7.1 Alarm Check ................................................................................................................................ 17-7
17.7.2 Parameter Setup and Check before Resuscitation ..................................................................... 17-8
17.7.3 Use of the Resuscitation Function ............................................................................................ 17-10
17.8 Oxygen Therapy ........................................................................................................................... 17-12

Chapter 18 Care and Maintenance ...................................................................................... 18-1

18.1 Maintenance Inspection ................................................................................................................ 18-1

18.2 Maintenance Schedule .................................................................................................................. 18-1

Chapter 19 Cleaning and Disinfection.................................................................................. 19-1

19.1 Overview........................................................................................................................................ 19-1

19.2 Disassembly of the Infant Radiant Warmer ................................................................................... 19-1
19.3 Cleaning and Disinfection of the Infant Radiant Warmer .............................................................. 19-3
19.4 Cleaning and Disinfection of Individual Components .................................................................... 19-5
19.4.1 Probe (Reusable) ......................................................................................................................... 19-5
19.4.2 Cleaning and Disinfection of NIBP Cuff ....................................................................................... 19-5
19.4.3 Cleaning and Disinfection of SPO2 Sensor ................................................................................... 19-6
19.4.4 Cleaning of Printer ...................................................................................................................... 19-6

Chapter 20 Accessories ....................................................................................................... 20-1

Chapter 21 EMC .................................................................................................................. 21-1

Chapter 22 Specification Parameters .................................................................................. 22-1

 Chapter 1 User Responsibility

1.1 Safety Information

Warning

l To prompt the situations that may lead to serious consequences, adverse events or
endangering the safety.Failure to follow the warnings will result in serious personal injury or
death to the user or Pediatric.

Caution

l To prompt potentially hazardous or unsafe practices, if not avoided, it may cause minor
personal injury, product malfunction, damage or property loss, and may also cause more
serious damage in the future.

Note

l To emphasize important precautions, and to provide descriptions or explanations for better

use of this product.

Warning

l This product is delivered without disinfection. Clean and disinfect before using for the first
time.
l The Infant Radiant Warmer shall be thoroughly sanitized and disinfectedwhen in use for the
first time, or when rescue / care operations for one patient have been completed, or when the
Infant Radiant Warmer has been in continuous use for one week or contaminated. Refer to the
relevant sections of this Manual for cleaning and disinfection methods.
l This product must be cleaned with a national registered neutral detergent / disinfectant.
Certain components of the Infant Radiant Warmer may be damaged if other products (such as
alcohol) are used. Use the detergent / disinfectant according to the manual provided by the
disinfectant manufacturer.
l Before using this Infant Radiant Warmer, read the entire Manual carefully. Like all medical
devices, attempting to use this device without the knowledge of its operation can result in
injury to the Pediatric or the user.
l This device may only be operated by personnel trained in their operations, and shall be

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directed by a qualified medical personnel familiar with the risks and product advantages of

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 such device.
l This Manual also lists other precautions that apply to specific steps.
l When any abnormality or malfunction occurs in the device, stop using the device immediately.
In the meantime, turn off the power and transfer the patient, and timely inform the Company’s
after-sales service department or authorized maintenance service provider. Maintenance and
testing by non-authorized personnel of the Company shall be avoided by all means.
l The Infant Radiant Warmer shall only be used for the intended purpose as specified in this
Manual.
l Before putting the device into operation, the calibration procedures in this Manual shall be
completed. If any part of the calibration procedures is not passed, the device must be stopped
and serviced.
l Do not use this Infant Radiant Warmer in the presence of flammable anesthetic gases;
otherwise there is a risk of explosion.
l Be sure to disconnect the power before performing the repair or maintenance procedures
described in this Manual. Only when special instructions are given in the procedures can the
power be energized.
l Do not use this device in the presence of flammable anesthetic gases. Use of this device in the
presence of such gases can cause an explosion or a fire.
l Pediatric loss of water may increase while this device is in operation.The Infant Radiant
Warmer may exacerbate insensible water loss in an Pediatric.When using the Infant Radiant
Warmer to care for patients, take appropriate measures to maintain a well-balanced body fluid.
l Patients near the phototherapy apparatus may need to be protected, such as wearing
protective covers and goggles.
l The operator should not be in the area of radiation of phototherapy apparatus for too long,
otherwise it may have a bad influence.
l After phototherapy is actuated, phototherapy will mask the changes in the skin color of the
patient (such as cyanosis). Please monitor the patient closely.
l It is forbidden to store drugs and injections in the radiation area.
l Do not place any incubators, flashlights, grease or flammable vaporizing substances in the
vicinity of this device while oxygen is being supplied. Pediatric clothes and sheets shall be made
of pure cotton. Do not use the materials that are prone to generate static electricity. Physicians,
nurses and first-aid personnel who come into contact with this device shall wear cotton or fire-
resistant clothing.
l In the use of oxygen supply function, if grease or similar substances comes into contact with
hyperbaric oxygen, violent spontaneous combustion will occur.Do not allow these substances
to adhere to oxygen pressure regulators, oxygen cylinder valves, pipes, joints or other oxygen
supply equipment.

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l Use only special pressure relief valves or pressure regulating valves that are specifically marked
as oxygen supply on the high-pressure oxygen cylinders. Do not use valves for any other gases
than air and oxygen. It is dangerous to use such valves.
l During oxygen supply, be sure to follow the physician’s instructions.
l No smoking is allowed in the room where this device is installed. Do not place any source of
ignition in the room.
l When setup the Pediatric’s skin temperature, be sure to follow the physician’s instructions.
l Medical oxygen or medical air shall be used during oxygen supply or air supply.
l Improper use of the device’s phototherapy apparatus may result in injury to the patient. The
operator must undergo specialized training and use the phototherapy apparatus under the
guidance of a qualified healthcare provider who is familiar with its commonly known risks and
benefits in use.
l During phototherapy, place the patient in theInfant Radiant Warmer to ensure the safety.
l Changes in the patient’s environmental conditions (such as temperature, radiation source, etc.),
will affect the patient’s body temperature and bilirubin value. In order to ensure that the body
temperature of the patient undergoing follow-up care is able to remain stable, the suitability
and stability of the surrounding environment in which the phototherapy apparatus is located
shall be maintained as far as possible. Inappropriate and unstable surrounding environment
will have certain impacts on patients. If the surrounding ambient temperature is too low, it
may cause the patient to catch a cold due to the decrease in body temperature; if the
surrounding temperature is too high, the patient may overheat due to the increase in body
temperature. In addition, if the ambient wind speed is too large, the patient may also catch a
cold due to rapid decrease in body temperature.
l During operation, in case of the Infant Radiant Warmer used in conjunction with other
warmers (such as the phototherapy apparatuses, heating mattresses of the Company or other
companies), it may affect the temperature uniformity of these devices, resulting in unexpected
increase in the patient’s body temperature. Therefore, the operator needs to be concerned
about whether the temperature changes in patients are within a reasonable range.
l When a phototherapy apparatus is in use, it is suggested to activate the mode of Infant Radiant
Warmer; otherwise the temperature set in such mode shall be suitably regulated according to
the measured body temperature. In the meantime, it is necessary to reduce the air
temperature setup and heat output setup in the Infant Radiant Warmer or the heat output
setup in the heating mattress.
l Do not put your fingers into the gaps in the device to avoid being pinched.
l Lock the casters when using the device, in order to optimize the stability of this device’s
phototherapy apparatus and to prevent disengagement from the effective surface.
l The casters on the Infant Radiant Warmer must be locked during normal operation, so as to

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 prevent injury caused by accidental movement.
l Only use the parts and components provided by the Company, such as LEDs, etc. to ensure

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 the safety and effectiveness of the phototherapy apparatus.
l In order to ensure that the effectiveness of various functions of the Infant Radiant Warmeris
not affected by aging and other reasons, make sure to timely contact with Tende's local after-
sales department for timely maintenance and replacement of radiation sources, upon the
expiration of the service life.
l The expired Infant Radiant Warmer and its accessories, if disposed of at will, will cause damage
to the local environment and must therefore be disposed of or returned to the Company for
disposal in accordance with local laws.

l Do not use the Infant Radiant Warmer in a place where there is a strong electromagnetic field.
l Equipment that is susceptible to magnetic interference shall not be used near the Infant
Radiant Warmer, as it may interfere with them.
l After the phototherapy apparatus is turned on, if the light is not on, contact with Tende's local
after-sales department in time.
l When a phototherapy apparatus is running, it produces a certain amount of radiation.
Therefore, the operator must operate in accordance with the requirements of the operation
section.
l The source of radiation is light-emitting diode (LED), with a wavelength of 430mm to 490mm.
LED has a maximum radiation output of 45±25%μW/cm2/nm. The maximum ouput of LED
radiation refers to the maximum radiant power in LED radiation that may be generally achieved
or the maximum monopulse radiation energy, which is emitted from the LED component
palette in any direction at any time in the entire operating range.
l During phototherapy, the operator shall not look directly at the light beam or look directly at
the light beam through an optical device.
l Direct radiation from the light source can cause damage to the eyes. Therefore, patients who
are close to the phototherapy apparatus and those undergoing phototherapy must wear safety
goggles to prevent any symptoms such as photokeratitis or retinal thermal injury.
l Photoisomers of bilirubin may cause toxic reactions. For instance, patients may develop
diarrhea, lack of kernicterus and hemolysis, anemia and other symptoms. Consequently,
nursing staff shall strengthen nursing care.
l During phototherapy, the nursing staff should not stay in the light irradiation area for more
than 30 seconds, in order to avoid dizziness, nausea, blurred vision and other discomforts. If
the patient needs to be taken care of for a long time, it is recommended to temporarily turn off
the phototherapy apparatus.
l Failure to use or regulate the device, or perform each step of the phototherapy apparatus in
accordance with the above requirements may result in harmful LED radiation damage.
l After a phototherapy apparatus is actuated, it may interfere with clinical observation in ways
that mask changes in skin color.

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l Exposure to an actuated phototherapy apparatus may cause discomfort to accompanying

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 persons, for instance, eye irritation, nausea and headache.
l Do not mix different types and brands of electrodes. Mixture of electrodes may lead to greater
baseline drift or prolonged baseline recovery after defibrillation. Do not use dissimilar metal
electrodes; otherwise it will cause high polarization voltage.
l Monitor the patient and always check the connection between the probe and the Pediatric’s
skin.
l When the device is operating, the operator must always pay attention to the patient’s
condition, monitor and record the patient’s temperature on a regular basis, in order to check
for anomalies such as overheating or overcooling.
l Equipment that is susceptible to magnetic interference shall not be placed near the Infant
Radiant Warmer, as the warmer may interfere with them.
l Before placing the Pediatric, check whether the bedside guard has been securely installed to
prevent the patient from falling off from the bassinet and thus causing injury.
l When the guard is folded down, do not leave the patient unattended. Otherwise, the patient
may be in danger of falling off from the bassinet.
l Putting clothes or blankets on the patient will prevent the body part of the patient from
receiving infrared radiation heat effectively. It is recommended that patients in the Infant
Radiant Warmer should be exposed.
l Do not touch the heater and its shield of the warmer by hand to avoid being burned.
l Do not place any objects on the top of the Infant Radiant Warmer, otherwise it may result in
damage to the device or safety hazards.
l Avoid moving the warmer laterally to prevent the Infant Radiant Warmer from tilting sideways.
l The Infant Radiant Warmer needs to be moved by at least one person with certain strength.
Before movement, unplug the device’s power supply cord and all other cables.
l When the power supply of the whole machine is not connected, the power switch cannot be
turned on for a long time. Otherwise, the energy of the rechargeable battery inside the device
will be consumed for no reason, and the rechargeable battery may even be damaged.
l Only use skin sensors or other accessories / consumables provided by the Company. Otherwise,
the safety of the device will be reduced.
l If the Infant Radiant Warmer continues to be used upon its expiration, it will be prone to
failure and may not meet the original requirements for performance indicators, and will be
required to be decommissioned.
l The complete set of LEDs of the Infant Radiant Warmer’s phototherapy apparatus must be
replaced when needed.
l Don’t place objects (such as towels) or flammable materials on the hearting shell of the
device or hang them in front of the protctive net.
l Don’t block the ventilation slot of the heater, and don’t cover it with flammable materials.

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 Caution

l Use the accessories specified in this Manual to avoid damage to the Infant Radiant Warmer
and to keep the Pediatric safe.
l Properly keep or dispose of the Infant Radiant Warmer to prevent it from falling, crashing, or
being damaged by strong oscillations or other mechanical forces.
l Before powering on the device, verify whether the power supply in use meets the
requirements for the Infant Radiant Warmer’s nameplate label or for the supply voltage and
frequency specified in the User Manual.
l When the Infant Radiant Warmer and its accessories are about to expire, they must be
disposed of in accordance with the relevant local laws and regulations or the hospital’s rules
and regulations.

Note

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l Place the Infant Radiant Warmer where it is easy to observe, operate and maintain.
l This Manual describes the product according to the most complete configurations. The
product you purchased may not have certain configurations or functions.
l Place the User Manual near the Infant Radiant Warmer so that it can be conveniently and
timely obtained when needed.
l The Infant Radiant Warmer cannot be used at home.
l The Infant Radiant Warmer is limited to one Pediatric at a time.
l Regularly measure the patient’s bilirubin concentration.
l Use a hospital grade or hospital-specific three-wire grounding power output device, in order to
ensure the reliability of grounding. Do not use extension cords. If you have any questions about
the grounding power supply, do not operate the device.
l There is a danger of electric shock in the LEDs while opening the lamp housing of the
phototherapy apparatus.Product maintenance must be carried out by qualified maintenance
personnel.
l Validate that available Infant Radiant Warmer’s power supply is compatible with the available
power specifications indicated on its nameplate.
l The electrical safety of the auxiliary devices shall be consistent with the safety standards
required by IEC 60601-1（GB 9706.1）.
l This device uses the plug of the power cord as the breaking device of the power supply.
Consequently, unplug the power cord when the device is informed of to ensure safety.
l Ensure that this device is properly grounded. If there is any doubt about the grounding
connection, stop using this device.
l Due to the danger of electric shock, in the case that the device can be maintained only after
disassembly, the device shall be submitted to qualified maintenance personnel.
l Only use the power cord provided with this device, otherwise it will reduce the safety of the

Page 1-10
 equipment.
l When plugging the power cord, hold the power plug by hand. Do not plug the power cord by
pulling wires.
l Do not bend the connection of the power cord.
l Do not place any object near the power plug to avoid difficulties in removing the power plug in
case of emergency.

1.2 Environment
Follow the instructions below to ensure the absolute safety of the electrical installation.
The operating environment of the Infant Radiant Warmer shall reasonably avoid vibration, dust, corrosive or
explosive gases, extreme temperature, humidity, etc.
Operating Environment
Temperature: 18°C to30°C
Relative humidity: 15% to 80%!do not consider the case of copression", non-

condensingAtmospheric pressure: 70.0kPa to 106.0kPa

Air velocity in the operating environment: < 0.3m/s .If the rate is >0.3m/s, it may cause slow heating and
uneven temperature.
Transport and Storage Environment
Temperature: -20°C to 60°C

Relative humidity: 15%to 80%!do not consider the case of copression", non-

condensingAtmospheric pressure: 50.0kPa to 106.0kPa

Ambient temperature beyond this range may affect the accuracy of the device and cause damage to
components and wiring. Do not use this device in an environment other than those specified above;
otherwise it may cause malfunctions or failure to meet the requirements for performance indicators.

Page 1-11
 Chapter 2 Overview
The Infant Radiant Warmer consists of six major components: foundation assembly, bassinet assembly,
vertical post assembly, lamp holder assembly, bracket assembly and tray assembly.

2.1 Views of the Infant Radiant Warmer

VAV-IW frontal perpective view:

10
11

12
10
13
9

14 8
7

15
3

16 2

Figure 2-1 VAV-IW Frontal perspective view of the Infant Radiant Warmer

No. Name No. Name

1 Caster with brake 9 Touch screen
2 Foundation 10 Gesture audio paused
sensor
3 Drawer 11 Alarm indicator
4 Lifting debris hanging pole 12 Rotatable lamp holder

Page 2-1
 5 Main bassinet 13 Infusion port
6 Resuscitation system 14 System switch
7 Tray 15 Lifting shield
8 Shuttle button 16 Lifting pedal button

VAV-IW Rear view:

5 4
6
3
7

8
2
9

10 1

Figure 2-2 VAV-IW Rear view of the Infant Radiant Warmer

No. Name No. Name

1 Oxygen cylinder 6 Data interface
2 Oxygen inlet 7 Auxiliary output
3 AC filter power supply 8 Pressure relief port
4 Thermovent 9 Air inlet
5 Buzzer 10 Air cylinder

Remark: At the time of delivery, the auxiliary output has been protected by sheet metal below. The sheet
metal needs to be removed when in use.

Page 2-2
VAV-IW Right side:

2
1

Figure 2-3 VAV-IW Right side view of the Infant Radiant Warmer

No. Name No. Name

1 Five-parameter module 3 Armrest
2 Printer 4 Phototherapy and puncture light
switch

Page 2-3
2.2 Control Panel
(I) Infant Radiant Warmer’s control units include:
l touch button
l touch screen
l shuttle knob

1 2 3 4 5 6 7 8

11

12

9
13

10

18

19 17 16 15 14

Figure 2-7 Control panel of the Infant Radiant Warmer

1. Network setup: Fix the cursor at . Press to enter the menu “Network Bassinet No.”.
n Network Bassinet No.: It indicates the network bassinet number of the Infant Radiant
Warmerconnected to the central monitoring system, with an effective range of 1 to 255.
n Local IP: The default is 200.200.200.X (X refers to the network bassinet number, from 1 to 255).
n Subnet Mask: 255.255.255.0.

Page 2-4
 n MAC: The default is 08:00:3e:26:0a:55, which is related to the machine’s network card.
n Server Address: The default is200.200.200.100, which is mainly theaddress of the server of
thecentral monitoring system connected to the Infant Radiant Warmer.

Note

l Connection status of the central monitoring system: The display of indicates that the

central monitoring system is not connected. The display of indicates that the central

monitoring system has been connected successfully.

l If this device is to be connected to other medical devices to form a system, it needs to be checked
for compliance.Ancillary equipment connected to logic or digital interface must comply with the
corresponding IEC standards (IEC 60950 for both digital and analogue equipment). In addition, all
configurations shall conform to IEC 60601-1. However, the devices that are not specified as part of
the system cannot be connected.Anyone that connects another device to the signal input and
signal output ports to form a medical system shall be responsible for ensuring that the system
complies with IEC 60601-1.If unsure, consult local Tende
dealer(s).

The network bassinet number of the Infant Radiant Warmer must be unique, and shall not conflict
withthe bassinet numbers of other infant radiant warmers for the central monitoring system. Otherwise, the
signalsof the Infant Radiant Warmer will cause crashes due to preemption of the central monitoring system’s
channel.If the Infant Radiant Warmer crashes due to a network bassinet number conflict, you need to
unplug the network cable, turn off the Infant Radiant Warmer, restart and reset the network bassinet
number, then
reconnect the network cable.

2. Patient information: Click on the bassinet number and name in the information prompt area. Then,
themenu “Patient Information” pops up.
n Medical record number: Support the input of 0-9999999999999999.
n Bassinet number: It refers to the bassinet number of the Pediatric to be monitored. Name: It refers
tothe name of the Pediatric to be monitored.
n Patient type: Patient type (Pediatrics, neonates), neonates by default.
n Gender: Pediatric gender (male, female).
n Height (cm): Enter the Pediatric’s height through a pop-up keypad, ranging from 1 to 100. Accurate
to one after the decimal point.
n Weight (g): Enter the Pediatric’s weight through a pop-up keypad, ranging from 1 to 9999. You may
also select the “Warmer Setup” in the drop-down menu bar. Select “WEIGH INFANT”. See “6.6
WEIGH INFANT” for detailed operation.After weighing the Pediatric, the weighing value will be
automatically displayed here.
n Blood type: Type O, Type A, Type B, TypeAB and others.

Page 2-5
n Date of birth: Xday XmonthX year (date of birth is the first day of life).
n TEL: Enter the contact numbers of the pantient’s parents through a pop-up keypad.

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 n Mother: Enter the mother’s name through a pop-up keypad, supporting for English, Pinyin,
Wubiand handwriting input.
n Physician: Enter the physician’s name through a pop-up keypad, supporting for English, Pinyin,
Wubi and handwriting input.
n Remark: Enter the information of the Pediatric’s parents.This device supports 40 characters
ofChinese input and 80 characters of English input.
n Receiving / dismissing patient: If the Pediatric is updated, the current Pediatric’s information will
bedeleted.
3. Technical alarm information prompt: For instance, ECG lead is off, SPO2 probe is disconnected, etc.
4. Parameter alarm information prompt/ alarm event review: The parameter alarm information will be
displayed in this position. For instance, ***RR is too high, ***HR is too low, etc. When clicking here,
the window “Alarm Event Review” will pop up. The user can screen the alarm event display based on
thealarm start time and recall event.

5. Apnea monitoring: When the apnea monitoring switch is turned on, the icon “ ” is displayed.
Whenthe apnea monitoring switch is turned off, the icon disappears.
6. Alarm audio paused status indicator/volume setup:

Alarm audio paused status indicator: When the audio paused button is pressed, the icon“ ” will
show up in this area. Meanwhile, the countdown time will be displayed under the icon. the alarm audio
paused time is 120s, The optional time interval is 1 to 15 minutes, but the risk of modification time
is

borne by the user.when time is up, this icon is displayed as “ ”.

Volume setup: the volume range is 1-6 levels. When the device is in the “alarm state” or “AC power off”
state, the volume range can’t be set, and in the state of “AC power off”, the volume will automatically
upgrade to level 6 for alarm prompt.
Note

l The alarm indicator is off in normal state. When an alarm occurs, the alarm indicator blinks or
is always on. The color of the light represents a certain alarm level.For details; see the “Chapter
15 Alarm”.

7. Date and time displays: Enter “maintain” → “Datatime setup”, set the system time according to local
time, including year, month, day, hour, minute, second, date format, time format. After selecting
“enter”,the setup take effect immediately.
8. Battery power display: Display the current battery status.
9. Physiological parameter display area:
NIBP

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# NS, ND and NM from left to right(Unit: mmHgorkPa)
ECG
# HR or PR (Unit: beats / min)

Page 2-8
 SpO2
# SpO2 (Unit :%)
# PR (Unit: beats/ min)
RESP
# Respiratory rate (Unit: times / min)
# The parameter value is refreshed every second, while the NIBP valueis refreshed once per
measurement.
CO2 (optional)

# EtCO2 (Unit: mmHg or kPa)

# INS CO2 (Unit: mmHg or kPa)
# AWRR(times / min)
10. Menu bar:
l Warmer setup: Pediatric skin temperature setup, operating mode (Infant Mode Setup / manual mode
setup), LIGHTING SETUP, phototherapy SETUP, WEIGH INFANT, and bassinet height adjustment. For
details, refer to the following chapters.
l Apgar setup: Counter / countdown timer setup. For details, refer to the following chapters.
l Physiological setup: ECG setup, NIBP setup, SpO2 setup, RESP setup, CO2 setup and information review.
For details, refer to the following chapters.
l System setup: Alarm setup, option setup, device setup, device information, device maintenance,
anddemomode.For details, refer to the following chapters.
l NIBP measurement: Carry out the NIBP measurement. For details, refer to the following chapters.
l ADJ (adjust) Bed tilt: Click the tilt of the bed on the touch screen, and press the button on the interface
tochange the angle of the bed.
l Screen freeze: Click the “Screen Freeze” on the touch screen, then the waveform area on the screen will
be frozen. Rotate the shuttle button to observe the graphics stored in 4min. Click the “Screen Freeze”
again to release the screen freeze.
l Print: Click the “Print” on the touch screen to print the corresponding waveform and Pediatric
information. Click once to start printing. Click again, and then the priter will stop work after the printing
is completed.
l Lock screen: Press and hold the “Lock Screen” on the touch screen for screen locking. The icon

“ ” shows up on the screen and flicker. Press and hold again for release. The icon “ ” shows
up.

Note

Page 2-9
 l The trend chart screen does not retain data that is not currently displayed. For instance, if you
choose to display only one hour of trend data, the first hour of data no longer appears after one
hour of display.

11. Apgar setup: Counter / countdown timer setup. For details, refer to the following chapters.

Page 2-10
12. Physiological waveform/ Temperature trend:
A. Click the “Physiological Waveform” on the touch screen to display the ECG, SPO2, RESP / CO2
waveform. Click the corresponding waveform to set the corresponding waveform parameters.
(1) ECG waveform area: Display the ECG waveform; set the corresponding waveform’s lead name (I, II,
III), exchange waveform, gain, waveform speed, filtering method, waveform color and waveform
style.
(2) RESP waveform area/CO2waveform area: Exchange waveform, gain, respiratory lead, respiratory
filter, waveform speed, waveform color and waveform style.
(3) PLETH waveform area: Exchange waveform,waveform speed, waveform color and waveform style.
B. Click “Temperature Trend” on the touch screen to display the Pediatric’s skin temperature and the
trend charts at a set temperature of 4h, 12h, 24h, 2d, 3d and within 7d (2d by default).
13. Manual mode setup / Infant Mode (baby mode) Setup: Set the power in the manual mode setup. Set
the Pediatric temperature in the Infant Mode Setup.
14. Shuttle button: A rotating shuttle may be used to select menu items and change setup. It can be rotated
clockwise or counterclockwise, and pressed to confirm the current selection.You can operate the menus
and windows through rotating shuttle.
15. Mode touch key: After touching this key, the touch key turns blue, and it is likely to toggle between the
Infant Mode Setup and the manual mode setup.
16. Audio paused touch key: After pressing this button, the indicator is on, and the audio paused is
actuated. After the audio paused is over, the indicator will be off.
17. Power AC indicator: After powering on, the indicator lights up. After the device is turned off, the
indicator will go out.
18. Battery working indicator: lighting indicates chaging, flashing indicates bettery power supply.
19. Device switch: OFF / ON.

2.3 External Interface

2.3.1 Printer

($) There is a heat-sensitive printer (optional) on the right side of the Infant Radiant Warmer, as

shownin Figure 2-8:

a) Open the door using the latch above the printer door.
b) Take away the empty paper core.
c) Insert a new roll of paper and secure it to the paper clip.
The paper roll is discharged from the bottom, over the
topof the printer door.
d) Extend at least one inch of paper over the edge of the door.

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e) Turn the printer door up until it is closed. Figure 2-8 Printer

f) Boot logging to check for correct installation. If it is unable to print, the paper may be loaded upside

Page 2-12
 down. Try to reload the paper.
2.3.1.1 Record Type
In the triggered way, records can be divided into:
² Manually initiated real-time recording
² Alarm record triggered by parameter overrun, etc.
Certain feature-related records
² Freeze the waveform
² Event: parameter alarm event, arrhythmia alarm event, manual event
2.3.1.2 Recording operation
u Start the record manually:
Ø Select the baby monitor warm-up menu bar function key to start real-time recording.
Ø After freezing the waveform, select the “Print”button to print the frozen time waveform.
u Stop recording manually:
Ø During the printing process, click the “Print” function button on the baby monitor warm-
up menu bar, and the printer will stop after printing the report.
u The printer automatically starts recording in the following situations:
Ø When “Auto Print Alarm”of the alarm setup of the system, “Alarm Switch” and “Alarm
Print”of a parameter are set to “On”, once the parameter is alarmed, the baby monitor
warming station will be triggered to start an alarm record.
u The printer will automatically stop recording in the following situations:
Ø Record task completion
Ø Printer is out of paper
Ø The printer has failed
2.3.1.3 Printer Setup
Open “System Setup” and select “Print Setup” under “Device Setup” to enter the related interface.
Record waveform:
The printer can print up to 2 waveforms at a time. The system prints the ECG waveform and blood
oxygen waveform displayed on the current interface by default.
Ø Set the paper speed
1) Under this menu, select “Paper Speed”.
2) Paper feed speed: “25mm/s”, “50mm/s”.
Ø Set up real-time recording:
1) Under this menu, select “Record Time”: Select “3 seconds”, “5 seconds”, “8 seconds”,
“Continuous” according to your needs.
If “8 seconds” is selected, it means that the waveform of 8 seconds after the current time is
recorded.
If “Continuous” is selected, the waveform after the current time is recorded, and manual

Page 2-13
 Ø Set the grid switch
Select “Grid Switch” to switch to "On" or "Off". If it is on, there will be a grid display on the paper
when the printer is output. If it is off, there will be no grid display on the paper when the printer is
output.
Note

= When the sound of the running printer or the output of the recording paper is abnormal, check
for paper jam. If so, open the printer’s door, reloadthe recording paper, and then close the
printer door.

Caution

l Carefully install the recording paper, otherwise the thermal head may be damaged.
l During the output of the printer, the recording paper should not be pulled out forcefully;otherwise
the printer may be damaged.
l Do not leave the recording door open unless it is a paper change or troubleshooting.
Clear paper jam
When the sound of the printer operation or the output of the recording paper is abnormal, please
check ifit is jammed. If it is, please follow the steps below to clear it:
1) Open the printer door.
2) Take out the recording paper and cut off the wrinkled part.
3) Reinstall the recording paper and close the printer door.
2.3.1.4 Cleaning Printer
After long-term use of the printer, paper dust and impurities accumulate on the printer head, affecting
thequality of the recording and the life of the printhead and roller.
Clean:
1) Before cleaning, take measures to prevent damage to the printer caused by static electricity.
2) Open the printer door and take out the record and use a cotton ball to draw the right amount
ofalcohol.
3) Gently wipe the surface of the thermal head of the printhead.
4) After the alcohol is completely dry, reinstall the recording paper and close the printer door.

Note

= Do not use anything that can damage the heat sensitive parts, such as sandpaper.
= Do not squeeze the thermal print head hard.
2.3.2 Cartridge
There is a C31 module on the front of the Radiant Warmer, as shown in Figure 2-9:
① ECG cable jack
② NIBP cuff jack
③ SpO2 sensor jack
Page 2-14
 ④ CO2 jack (optional)
Remark: ThisInfant Radiant Warmer has no IBP function.

④ ①

Figure 2-9 C31 module

(%) There is a multifunctional plugboard parallel to the Pediatric guard on the front of the Infant

RadiantWarmer, as shown in the figure below:

① Weighing jack (grass green)
② Apnea wake-up jack (purple)
③ Temperature detection jack (blue)
④ Intermediate plate on the vertical post

Figure 2-10 Multifunctional plugboard

Caution

l Load the recording paper carefully; otherwise it may cause damage to the thermal printer head.
l During the output of the printer, do not pull out the recording paper with force. Otherwise, the
printer may be damaged.
l Do not leave the printer door open unless it is necessary to change paper or perform
troubleshooting.
l If more than one external aquipment is connected to the monitor at one time throught the patient
cable socket, network connector or other signal interfaces, the total leakage current should be
compliant with the specified in IEC60601-1.

Page 2-15
2.4 Built-in Rechargeable Battery
The Infant Radiant Warmer is equipped with a built-in rechargeable battery. When AC power supply is
connected, the battery will automatically charge when the power switch is on, regardless of whether the
Infant Radiant Warmer is on or off, until it is fully charged. In the event of a sudden power outage, the device
will automatically power the Infant Radiant Warmer with the battery, without disruption to the operation of
the Infant Radiant Warmer. When the AC power supply is restored within a specified time, the battery
begins to charge. Meanwhile, the system stops using battery power and automatically switches to the AC
power supply

to ensure its continuous operation. There is a symbol “ ” in the upper right corner of the
screen, indicating the charging state. After fully charged, the battery is able to provide sustainable power
supply for1h (except for heating, lifting and tilting functions).
Once AC power outage, the blood pressure measurement, ECG and printer functions can work normally,
except for heating function, blue light therapy device treatment, puncture lamp, bed tilt function and lifting
function.
The battery icon shown on the screen indicates the current battery status:

: It indicates that the battery is sufficient;

: It indicates that the battery power is more than

enough; : It indicates that the battery power is general;

: It indicates that the battery power is a bit less, and it shall be considered to charge the battery;

: It indicates that the battery power is Small amount, and the Infant Radiant Warmer sends
awarningmessage due to low battery power.
The above ICONS are displayed in a loop to indicate charging.

&It indicates that the battery power is consumed; The Infant Radiant Warmer starts counting down

for 5min, indicating that “Battery power is too low, the device is about to shut down after xxs”.Meantime,
Use AC power supply to power the Infant Radiant Warmer to resume operation and to charge the battery. If
not charged in time, the Infant Radiant Warmer will automatically shut down after the countdown.

: It indicates that there is no battery or the battery is damaged.

The battery is used to issue a power failure alarm, which powers the memory circuit in the event of a power
failure.
If the battery is obviously damaged or the battery power is exhausted, it shall be replaced, and the discarded
battery shall be properly recovered and disposed of in compliance with relevant laws and regulations or the
hospital’s rules and regulations.

Page 2-16
 Note

= Before transporting the Infant Radiant Warmer or when not used for a long time, remove the
battery for safe keeping.
= If the Infant Radiant Warmer has a built-in battery, the battery must be charged after each use
to ensure that the Infant Radiant Warmer’s battery has sufficient power reserve.
= In order to extend the life of the rechargeable battery,if the battery is stored for a long time, it is
recommended to charge the battery once every three months to prevent over discharge of the
battery.
= The battery-powered time is dependent on the Infant Radiant Warmer’s configurations and
operations, for instance, frequent NIBP measurements can shorten the battery’s power-on time.
= In order to extend the battery’s service life, use the battery at least once a month and charge
the battery when the battery is running out.
= Check and replace the battery on a regular basis. The battery-powered time is dependent on the
frequency and time of use of the Infant Radiant Warmer.If the battery is properly maintained
and stored, its service life is approximately 3 years.If the battery is used improperly, its life may
be shortened. It is recommended to replace the battery every 3 years.
= In case of battery failure, contact the manufacturer for replacement by the designated
maintenance personnel. Do not replace the battery on your own.
= The battery-powered Infant Radiant Warmer will automatically shut downwhen battery power
is low.
= BP measurement and printer are able to function properly 5min before the Infant Radiant
Warmerstarts counting down.

Warning

l Do not disassemble or short-circuit the battery, or throw it into fire. Otherwise, it will cause
battery ignition, explosion, hazardous gas leakage or other problems.
l Battery electrolyte is harmful. In case of battery electrolyte on the skin or in the eyes, rinse
immediately with water and seek help from a doctor.
l Only use the battery specified by the manufacturer.
l Put the battery out of the reach of paediatricren.
l If the battery is missing, the Infant Radiant Warmer must be powered using the appropriate
power supply.
l The battery of this device is not a user-serviceable component. Only authorized maintenance
representatives can replace the battery.If the system is not used for a long time, contact your
maintenance representative to disconnect the battery.

Page 2-17
2.5 Symbols Used on the Device or in the Manual

Description Symbol
Alternating current

Battery working indicator

Alarm audio
paused

Identifications
on the key Mode conversion

System switch OFF or ON

Danger! High temperature

Patient’s eye protection symbol

Gesture audio paused

USB interface

Network port

Serial port

Temperature probe interface

Skin T

Apnea wake-up interface

WAKE

Weighing interface

Phototherapy screen print

White light screen print

Main power input

Auxiliary output socket
identification

Page 2-18
 Equipotentiality

Protective ground

Fuse

Weighing tray label

ON

OFF

Vacuum switch (front shell)

Medical gas switch

Vacuum

Oxygen concentration

Vacuum pressure regulating

range

Mixed gas flow calibration

PIP

PIP unit

PIP limit value

PIP less than the limit scale

Page 2-19
PIP greater than the limit scale

Flow unit

Oxygen concentration scale

Vacuum connector (rear shell)

Oxygen inlet connector

Air inlet connector

Pedal screen print

Electrical box cover label

Drawer load-bearing label

This Way Up

Fragile
Handle with care

Do not Stack

Page 2-20
 Keep away from rain

Center of Gravity

Do not roll

Environmental protection

Environmental protection for 20

years

Separate collection for

electricaland electronic
equipment in accordance with
directive
2002/96/EC (WEEE)

Serial Number

Manufacturer

Refer to instruction
manual/booklet or

Authorized representative in the

European Community

European Conformity Complies

with medical device directive
93/42/EEC
Defibrillation-proof type BF
applied part
Defibrillation-proof type CF
applied part

Page 2-21
 Temperature limits

Humidity Limitation

Atmospheric pressure Limitation

Date of manufacture

Non-protected against water

2.6 Protective Grounding

The metal housing of the Infant Radiant Warmer must be grounded to protect Pediatrics and operators.
Therefore, the Infant Radiant Warmeris equipped with a three-wire power cord that, when plugged into a
matching three-wire outlet, grounds the Infant Radiant Warmer through the ground wire (protective ground)
inthe power cord.If there is no three-wire outlet, contact the hospital’s electrical management staff in time.

Warning

l Do not connect the Infant Radiant Warmer’s three-wire power plug to a two-wire outlet. Only
connect the power cord to a three-phase socket with the grounding terminal and correct
grounding, in order to ensure reliable grounding.
l If there is any doubt about the grounding, do not use this device.
l The system connected to the auxiliary output power supply must be a product certified by the
specified IEC standards, such as IEC 60950 Data processing equipment and IEC 60601.1 Medical
electrical equipment (GB 9706.1 in Chinese).
l The connection between the device and the auxiliary output power outlet will effectively reduce
the safety factor of the device.
l When configuring the auxiliary output power socket, the Infant Radiant Warmer connected to

Page 2-22
 theauxiliary output power socket shall be within the voltage-current specifications of
theauxiliary output power socket. The Infant Radiant Warmer connected to theauxiliary
output power socket shall be the manufacturer-specified device. Otherwise, it may lead to
excessive leakage currentthat could be hazardous to the patient or operator and may damage
the Infant Radiant Warmer or externally connected Infant Radiant Warmer.

Connect the ground wire to the equipotential ground terminal of the device.If it is unclear whether a
particular combination of equipment is dangerous, for instance, the danger caused by the accumulation of
leakage current, the user shall consult the relevant manufacturer or other specialists, so as to ensure that all
of the necessary security of equipment is not compromised by the recommended combination.

2.7 Equipotential Grounding

The primary protection of the Infant Radiant Warmer has been included in the system of protective
grounding (protective ground) of the housing by grounding the power plug. For internal cardiac
examinations, the Infant Radiant Warmer must be individually connected to the equipotential grounding
system.One end of the equipotential ground conductor (potential equalization conductor) is connected to
the equipotential ground terminal on the Pediatric guard in rear of the Infant Radiant Warmer, while the
other end is connected to a connector of the equipotential system.If the protective grounding system is
damaged, the equipotential grounding system will be able to bear the safety function of the protective
conductor. Cardiac (or brain) examinations shall only be carried out in the medical premises equipped with a
protective grounding system. Prior to each use, check whether the Infant Radiant Warmer is in good
operating condition. The cable connecting the Pediatric and the Infant Radiant Warmer must be free of
electrolyte contamination.

Note

If the equipotential grounding affects the use of equipment, contact the Company’s after-sales
service department or agents.

Page 2-23
 Chapter 3 Pre-operational Check

3.1 Appearance Inspection

1) All control devices on the panel of the Infant Radiant Warmer shall be properly and securely installed
and function in accordance with the functions indicated on the panel;
2) The coating, plating and injection molded parts on the outer surface of the Infant Radiant Warmer
shallhave no scratches and cracks;
3) The text and markings on the Infant Radiant Warmer shall be clear, accurate and secure; the
fastenersshall not be loose.

Warning
l If any damage is found, contact the relevant staff in the hospital or Tende's after-sales service
department.

3.2 Mechanical Check

Warning

= Before using this device, you must read this Manual thoroughly. Attempting to use the device
before thoroughly understanding the device operationmay result in injury to the Pediatric or the
user.
= Do not perform pre-operational checkout on the device when there is an Pediatric in the Infant
Radiant Warmer.
= Before putting the device into operation, it is necessary to complete the pre-operational check
described in this Manual. In the case that the device does not complete any part of the checkout
operation, the device must be stopped immediately and repaired.

1) Disconnect the power cord when performing the mechanical check before operation.
2) Check the power cord for damage. In the event of noticeable damage, replace the power cord.
3) Check the parts of the entire device for damage or loss.
4) Make sure that all casters are in close contact with the ground to ensure the stability of the device.
When locking the caster brake, make sure that the Infant Radiant Warmer is in place. When releasing
the caster brake, make sure that the Infant Radiant Warmer is able to move smoothly on the ground.
5) Check the operation of the Pediatric guard. It shall be securely locked in the upright position.

Page 3-1
3.3 Controller Check
(1) Connect the power cord to the AC power supply. Make sure that the power switch is in “I” state. When
the AC power is switched on, the AC power indicator lights up. If the indicator is still off, it indicates that
the system has no power supply.
(2) Connect the temperature probe to the temperature detection jack on the multifunctional plugboard.
(3) Set the device switch to “I” state to validate the following items:
a) The operating indicator blinks until it is always on, the display screen turns brighter
b) Display the Company’s LOGO interface, after about 5 seconds, the self-test is successful.
c) After the device self-test is successful, the “warm-up mode” is automatically turned on, the heater
automatically runs at 100% power, and the seven-minute countdown starts. The power of the
heater is about 45 mW/cm2, at the meantime, the “enter” button will always flicker.
d) The user can click the “enter” button to enter the main interface, and the device works by default
in the baby mode setup. If the confirmation button is not clicked, the device is still warming up
after seven minutes, but the heater power is reduced to 50% until the user presses the "confirm"
button, the warm-up is completed, and normal operation begins.
(4) If the AC power is lost in the “warm-up mode”, the countdown is paused and the warm-up function is
temporarily unavailable. However, the user will click the “confirm” button on the interface to enter the
baby mode. However, after AC power loss, blood pressure measurement, ECG and printer functions can
work normally, but the heating function, blue light therapy device treatment, puncture lamp, bed tilt

function, and lifting function cannot work normally.

Figure 3-1 Boot warm-up interface in normal state

Page 3-2
 Figure 3-2 Boot warm-up interface under AC power-off state (warm-up function is unavailable, countdown is suspended)

(5) Enter the main interface. The default is “Infant Mode”. User can regulate the temperature value.
(6) Check the temperature probe. Place the probe between the fingers for heating. Validate that the
Pediatric’s temperature reading is increasing.
(7) If user selects “Manual Mode”, the alarm information prompt area will display “please set the power”
with the alarm audio will start. When the user sets the power, the alarm will be cancelled automatically,
and the alarm audio will be automatically, and the alarm audio will be automatically closed.
(8) Check the operation of the bassinet lifting system. Raise or lower the bassinet to the utmost extent to
ensure that the device is able to operate smoothly. Check the lifting pedals on both sides of the
bassinetto raise or lower the height of the bassinet.
(9) Check the power failure alarm and battery backed memory.After unplugging the Infant Radiant
Warmer’s AC power plug from the wall outlet, you should be able to hear the alarm.Wait for 1 to 2
minutes and then insert the Infant Radiant Warmer’s AC power plug to confirm that the alarm is cleared.

Note

l The fully charged battery shall be able to supply a power failure alarm for at least 60 minutes
(Clause 201.12.3.101 in IEC 60601-2-21).During full recharging, the charging time is less than 12h
in ON state and less than 8h in OFF state. Charging to 90%, the charging time is less than 10h
when the power is turned on, and the charging time is less than 6h when the power is turned off.
l Do not place a Pediatric in the bassinet in warm-up mode. When the patient is placed on the
device, switch to manual mode or Pediatric mode immediately.
l Radiant heat in warm-up mode is less than about 45mW/cm2.
l Do not use the temperature probe as an anus probe.

Page 3-3
 Chapter 4 Installation and Connection
Note

l In order to ensure the normal operation of the device, read this Chapter prior to use, and install
the device as required.
l Place the device on a stable surface.

4.1 Connecting the AC Power Supply

Steps for connecting the AC power cord:
Make sure that the AC power supply should meet the Infant Radiant Warmer’s nameplate

identification:100 -127V', 50 Hz /60Hz, 220-240V', 50 Hz /60Hz

Use the power cord supplied with theInfant Radiant Warmer. Insert the other end of the power cord
into agrounded power socket.

Note
l Connect the power cord to the hospital socket.
l In case of configured with a battery, the Infant Radiant Warmer must be recharged after
transportation or storage. If directly turned on without being connected to the AC power supply,
the Infant Radiant Warmer may not function properly due to insufficient battery power. Turn on the
AC power supply and charge the battery, regardless of whether the Infant Radiant Warmer
is on or off.

Connect the equipotential ground wire, if necessary.

4.2 Connecting the Sensor

Connect the required sensors to the Infant Radiant Warmer and the Pediatric’s test site.

Note

l Refer to Chapter 9 to Chapter 13 for proper connection methods of various sensors and the
relevant requirements.

4.3 Connecting the Gas Source

The Infant Radiant Warmer provides the interfaces for air and O2 sources in the pipes. The oxygen source
inlet is marked with the O2 identification, indicating that oxygen will enter the Infant Radiant Warmer from
this inlet during oxygen delivery. When oxygen delivery is required, connect the gas hose to the oxygen inlet

Page 4-1
to ensure the oxygen supply. The gas pressure at the junction is within the range of 0.28 to 0.6MPa. Make
sure that the connection is in place. Then, use oxygen concentration test equipment for calibration. After
calibration, click the oxygen concentration parameter area on the touch screen to set the oxygen
concentration switch to “ON” and to set the oxygen concentration value to the desired value. After setup,
the Infant Radiant Warmer will automatically supply oxygen.
After connecting the gas source, prior to official use, calibrate the oxygen concentration according to the
following methods.
Oxygen Concentration Calibration:
Connect the gas source. Connect the oxygen concentration test equipment to the oxygen therapy interface.
Regulate the oxygen flow knob to 8L/min and the oxygen concentration knob to 50%. Turn on the airway
switch for calibration. The maximum allowable error is ±3%.

Warning

Page 4-2
l This operation is performed only when oxygen delivery is required.
l Oxygen supply must comply with the doctor’s instructions.
l Do not place any incubators, flashlights, grease or flammable vaporizing substances in the vicinity
of this device while oxygen is being supplied.
l During oxygen supply, physicians, nurses and first-aid personnel who come into contact with this
device shall wear cotton or fire-resistant clothing.
l Pediatric clothes and sheets shall be made of pure cotton. Do not use the materials that are prone
to generate static electricity.
l Use only special pressure relief valves or pressure regulating valves that are specifically marked for
oxygen supply on the high-pressure oxygen cylinders. Do not use valves for any other gases than
air and oxygen. It is dangerous to use such valves.
l If grease or the like comes into contact with hyperbaric oxygen, violent spontaneous combustion
will occur. Do not allow these substances to adhere to oxygen pressure regulators, oxygen
cylinder valves, pipes, joints or other oxygen supply equipment.
l Periodically check the oxygen concentration in air (20.9%) or pure oxygen concentration (100%)
with an oxygen monitor for accuracy.
l Be sure to follow your doctor’s instructions to determine the optimal oxygen concentration based
on PaO2 (measured PaO2). It is reported that it is extremely important to measure the oxygen
concentration in the device and to constantly analyze the oxygen content in arterial blood in order
to determine the required oxygen concentration, when a high-oxygen environment is required.
l The oxygen concentration setup knob or flowmeter cannot be used to accurately indicate the
oxygen concentration. Prior to oxygen supply, use a verified oxygen monitor or oxygen controller
to check the oxygen concentration under the guidance of a doctor.
l During oxygen delivery, the noise generated by the device will increase.
l Only use medical gas source. Other types of gas sources may contain water, grease or other

Page 4-3
 contaminants.
l If the central gas supply system fails, one or more of the connected devices will stop working.
Open the spare gas cylinders to ensure the normal operation of the Infant Radiant Warmer.
l After the gas supply is stopped, there will still be pressure in the pipe. Release the gas in the
pipe first and then unplug the pipe.

4.4 Mounting the Bracket

(1) Insert the small gasket (A in Figure I) into the correct direction along the bracket gasket slot (B in Figure
I).

Figure I
(2) After placement, align the entire bracket with the concavesurface of the vertical post. Insert from the
notches (D and E in Figure II) at both ends of the vertical post. Adjust the bracket to the appropriate

position according to the user’s needs.Then, use the knob (C in Figure I) to secure the bracket firmly.

(3) After fixing, insert the tray into the bracket on the left side of the vertical post, and the IV pole into
thebracket on the right side of the vertical post, as shown in Figure III.

Page 4-4
 Figure III

4.5 Using the Built-in Electronic Scale

The Infant Radiant Warmercan be configured with its own built-in electronic scale. Such electronic scale can
be operated through the menu setup on the touch screen.

Note
l Electronic scale cables can be connected or disconnected regardless of whether the device is on or
off.

Installation of electronic scales:

(1) Open the guard panel around the bed;

(2) Place the electronic scale weighing platform in the groove inside the bed;

(3) Pass the electronic scale cable through the soft wire slot on the inner panel and insert the connector
intothe weighing probe plug;

(4) Close the cover around the bed.

Page 4-5
 Chapter 5 Basic Operations

5.1 Device Startup

Connect the power cord to the AC power supply. Make sure that the power switch is in “I” state. When the
AC power is switched on, the AC power indicator lights up. If the indicator is still off, it indicates that the
system has no power supply.
After setup the device switch to “I” state, the operating indicator blinks until it is on. Meanwhile, the device
is in ON state, and the screen enters the Company’s LOGO interface. In addition, the warm-up mode is
automatically actuated. The heater automatically runs at 100% power. The power of the heater is about
45mW/cm2.
Users can click the OK button to enter the main interface. The device defaults to operate in the Infant Mode
Setup. If you do not click the OK button, the device will still be in warm-up mode after 7min, but the heater
power will be reduced to 50%, until you press the OK button. The warm-up will then be completed, and the
device will start normal operation.
If the AC power is lost in the “warm-up mode”, the countdown is paused and the warm-up function is
temporarily unavailable. However, the user will click the “enter” button on the interface to enter the baby
mode. However, after AC power loss, blood pressure measurement, ECG and printer functions can work
normally, but the heating function, blue light therapy device treatment, puncture lamp, bed tilt function, and
lifting function cannot work normally.

Warning

l Do not place the Pediatricon the bassinet in warm-up mode. The warm-up mode is only used to
rapidly heat the empty bassinet and keep it warm.
l When running this device, do not cover the heater cover with cloth.

5.2 Operating Steps

Warning

Page 5-1
l Before placing a Pediatric in the Infant Radiant Warmer, make sure that the caster brake is in
braking state.
l When using the Infant Radiant Warmer, a health care worker shallbe able to take care of the
Pediatric all the time.Regularly check the Pediatric’s body temperature to ensure the safety and
comfort of the Pediatric.
l When the audio paused is actuated, the Pediatric must be closely monitored.
l The use of electrosurgical (ES) equipment or other plant radiation equipment may affect the
operation of this device. The temperature probe lead shall be as far as possible from the ES

Page 5-2
 equipment. In addition, do not place too many cables on the bassinet. The use of ES equipmentor
other equipment for the radiated electric fields may cause indirect heating. The readings of the
temperature probe will increase by a few tenths due to the electrical energy absorbed.
l Direct sunlight or other sources of radiant heat can cause the Infant Radiant Warmer to raise its
temperature to a dangerous level.
l When lowering or removing the Pediatric guard on either side, a health care worker shallbe able to
take care of the Pediatric all the time.
l Radiation energy may have a negative impact on blood components.When using the IV system to
deliver blood components to the patients hooked up to the device,seal the tubing with aluminum
foil.
l Radiation energy may cause urine evaporation to accelerate, which may result in inaccurateurine
diagnostic test analysis and weight measurement.It is recommended to change diapers frequently.
l Use “Infant Mode Setups” unless explicitly specified to use “Manual Mode Setup”. Although both
modes require patient monitoring, “Manual ModeSetup” requires uninterrupted monitoring.
l In Pediatric mode, the systemcontrols the heating power through the PID algorithm, that is, the
system automatically sets the heating power according to the difference between the probe
temperature and the set temperature.During heating, the system adjusts the heating power in real
time according to the temperature rise of the probe until the probe temperature is stable at the
set temperature.
l Under “Manual Mode Setup”, the environment (high-flow air, direct sunlight, phototherapy lamp
use, etc.) or changes in Pediatric condition must be checked, and the heater power shall be
adjusted according to these changes.
l Under “Infant Mode Setups”, the Infant Radiant Warmer automatically adjusts the heater power
to maintain the desired skin temperature, and to reduce (but not completely eliminate) the need
to monitor the Pediatric and to control the temperature by regulating the “Infant ModeSetups”.
l Before placing a Pediatric, make sure that all the Pediatric guards are locked to prevent the
Pediatric from falling.
l The temperature probe is not insulated from the ground. Any other equipment used in
conjunction with the device must meet the requirements of IEC 60601-1 (GB 9706.1).
l Do not put objects within the irradiation range of the radiant heat. Otherwise, objects will heat up
and may prevent the Pediatric from getting heated.
l Do not place any objects on the lamp holder assembly.
l Do not connect unauthorized devices to the auxiliary power interface of the device.
l Heat dissipation is performed right above the lamp holder. Do not put your hands at the heat
emission hole on the lamp holder. Otherwise, it may cause burns.

Page 5-3
 l Check whether the probe is connected regularly. If the probe does not touch the Pediatric’s skin,
the readings will be inaccurate.
l When using a phototherapy lamp, the probe must be directly exposed to the radiant heat of the
phototherapy lamp.Do not block the probe.Phototherapy lamps may cause Pediatric skin
temperature to raise.
l Do not reuse the disposable probes. Cleaning and reusing of the disposable probes may cause
damage to the probe, resulting in inaccurate readings.
l Do not use the rectal temperature to control the Pediatric’s body temperature.
l Do not place the temperature probe under the Pediatric.
l Do not use it as an anal probe.
l When the Infant Radiant Warmer is operatingunder “Manual Mode Setup”, the guardian must
continuously monitor the Pediatric’s condition. Do not leave the Pediatric alone
unattended.Whenever possible, use the Infant Radiant Warmer under “Infant Mode Setup” in the
servo control.
l Firmly attach the temperature probe to the Pediatric’s abdomen. If the probe comes off the
Pediatric’s abdomen or is not properly positioned, it cannot accurately detect skin temperature.If
the temperature rises since the temperature probe is covered by a blanket, diaper or
Pediatric’s arm, or the temperature drops since the temperature probe is wet by urine or
chemicals, it will also be unlikely to accurately detect skin temperature.
l If the Pediatric spontaneously generates heat, or fever,the heater output will be reduced, orcause
other adverse consequences.

1. Select the “Warmer Setup” in the menu bar. Select “Infant Radiant Warmer Setup”. Or directly click on
the Pediatric temperature parameter area on the user interface to select “Infant Radiant Warmer
Setup”for temperature setup.
2. Place the Pediatric on the bassinet.
3. Place the temperature probe on the Pediatric’s skin. If the Pediatric is in a prone position, place the
probe on the Pediatric’s back. Before placing the probe, make sure the Pediatric’s skin is clean and dry.
Any of the following behaviors may cause the Pediatric to be heated too low or too high.
n Random pulling of the temperature probe can lead to inaccurate readings.
n When the temperature probe is not in contact with the Pediatric’s skin, it can lead to inaccurate
readings.
n When using a phototherapy lamp, if the probe is placed out of the reach of the phototherapy lamp
light, the phototherapy lamp will cause the Pediatric’s skin temperature to rise, resulting in
inaccurate readings.
4. Route the probe cable through the inlet on the Pediatric guard. Insert the probe into the temperature
detection probe jack on the multifunctional plugboard.

Page 5-4
 Note

l The device cannot differ cold (fever) on the skin but high temperature in the bodyfrom low body
temperature and skin temperature. The temperature measured by the skin temperature sensor is
only the Pediatric’s skin temperature, not the actual Pediatric’s body temperature. Therefore, the
Pediatric’s body temperature must be measured regularly to check for signs of fever or
apparent cooling.

5.3 Operation of the Pediatric Guard

Scale marks are located on the side guard, and the zero point thereof is in the middle of the guard. Extend

about 25cm to the left and right to estimate the Pediatric height, as shown in Figure 5-1:

Figure 5-1 Side guard

Except for the guard on the support side, other guards can be turned downwards. Pull the guard up first and
then to your side to turn it down. Pull the guard up to the vertical position, then press down again for locking.
The guard is then reset.

Warning
l If you open the Pediatric guard while having an Pediatric in the bassinet, watch the Pediatric
closely.
l If the Pediatric is very restless, always pay attention to him / her and do not walk away.
l Regularly check the device latch,and whether the screws and Pediatric guards are closedproperly,
so as to prevent the Pediatric from falling.

5.4 Using the X-ray Tray

When performing an X-ray procedure, make sure that the bassinet is horizontal first. Grasp one of the sides,
and pull the bassinet towards yourself. Stop pulling until the tray beneath the mattress is pulled out (it is
able to pull out the tray from both sides of the bassinet). Install the X-ray film cassette. The cassette can be
slid intothe space under the mattress without moving the Pediatric. As shown in Figure 5-2 below:

Figure 5-2 X-ray tray

Heater cover can be rotated clockwise or counterclockwise, so as not to interfere with X-ray photography.In

Page 5-5
this case, the tilt of the heater cover may be regulated to be aligned with the Pediatric, so as to prevent
asudden decrease in heat supply.
When the heater cover is tilted, a tilt alarm is given.

Warning
l Do not place the Pediatric on the X-ray film cassette.
l When the heater cover is tilted, the phototherapy intensity and the patient’s temperature will
be affected to some extent.
l Do not lean on the heater cover or apply excessive force to prevent it from rupturing.
l Do not hang anything on the heater cover to avoid catching fire.
l Do not allow the heater cover to lean too long. Otherwise, the outside of the heater cover will be
heated and become hot.

5.5 Pillar Orbit

There is one orbit on either side of the pillar.
Options such as trays or IV poles may be mounted on either side of the orbit.

Warning
l When attaching optional accessories to the orbit, make sure that this device is level. The total
weight of the accessories and their carryingsubstances shall be less than 30kg.
l When mounting optional accessories to the orbit, pay attention to keep the device balanced so
that it will not fall over.
l For otherinformation on optional accessories mounted on the orbit, refer to the relevant
instructions provided with the accessories.

5.6 Common operation of each parameter module

5.6.1 Alarm Printing

1) On the user interface, select the parameter display area you want to set, or click “Physiological Setup” to
enter the setup menu of the corresponding parameter, for example: select ECG parameter display area →
“ECG SETUP” → “alarm print”.
2) Alarm printing: “On”, “Off”.
When “Auto Print Alarm” of “Alarm Setup” in “System Setup”, or “Alarm Switch” under the corresponding
parameter setup menu, when one of them is “Off”, “Alarm Print” here cannot be set; When both are “On”,
“Alarm Print” can be set.

Page 5-6
5.6.2 Alarm switch

1) On the user interface, select the parameter display area you want to set, or click “Physiological Setup” to
enter the setup menu of the corresponding parameter, for example: select ECG parameter display area →
“ECG setup” → “alarm switch”.
2) Alarm switch: “On”, “Off”.

5.6.3 Alarm upper and lower limit setup

1) On the user interface, select the parameter display area you want to set, or click “Physiological Setup” to
enter the setup menu of the corresponding parameter, you can find the alarm setup options corresponding
to each parameter. The alarm setup options corresponding to different parameters are slightly different. .
2) For example: Select ECG parameter display area → “ECG SETUP” → ECG corresponding alarm setup.

5.6.4 Default Configuration

1) On the user interface, select the parameter display area you want to set, or click “Physiological Setup” to
enter the setup menu of the corresponding parameter, for example: select ECG parameter display area →
“ECG SETUP” → “default configuration”.
2) Select “Default Configuration”, the setup of the corresponding parameter module will be restored to the
factory setup.

5.6.5 Exchange waveform

1) On the user interface, select the waveform you want to set, for example: select ECG “II” or “I” Waveform
→ “ECG Waveform” → “Exchange Waveform”.
2) Select the waveform you want to swap, for example: select PLETH. Then, on the user interface, the display
positions of the ECG waveform and the PLETH waveform will be interchanged.

5.6.6 Setup the gain

1) On the user interface, select the waveform you want to set, for example: select “II” or “I” waveform
→“ECG waveform” → “Waveform Gain” of ECG.
2) Select the appropriate waveform gain and the waveform gains corresponding to the waveforms of
differentparameters are slightly different.
Note

l When setup the ECG waveform gain, users need to pay attention: when the input signal is too
large, the peak may be truncated. At this point, the user can manually change the gain file of
the ECG waveform by referring to the actual waveform to avoid incomplete waveform display.

5.6.7 Waveform speed

1) On the user interface, select the waveform you want to set, for example: select “II” or “I” waveform →

Page 5-7
“ECG waveform” → “waveform speed” of ECG.
2) Select the appropriate waveform speed. The waveforms of different parameters correspond to
differentwaveform speeds.

5.6.8 Waveform color

1) On the user interface, select the waveform you want to set, for example: select “II” or “I” waveform
→“ECG waveform” → “waveform color”of ECG.
2) In the “Waveform Color” menu, the user can set the color to “Green”, “Cyan”, “Red”, “Yellow”, “White”,
“Blue” or “Purple”.

5.6.9 Waveform Style

1) On the user interface, select the waveform you want to set, for example: select the waveform of RESP →
“ECG Waveform” → “Waveform Style”.
2) In the “Waveform Style” menu, the user can select the appropriate waveform style according to his own
needs. The waveforms of the different parameters correspond to different waveform patterns. The style has
a total of four lines, a color scale, a bold or a fill.

5.7 Device Shutdown

If you no longer use the Infant Radiant Warmer, follow these steps below to turn off the Infant Radiant
Warmer:
① Confirm that it is likely to stop using the Infant Radiant Warmer.
② Set the device switch to off state “OFF”.
③ Set the main power switch to off state “○”.

Page 5-8
 Chapter 6 Warmer Setup
Click the “Warmer Setup” in the drop-down menu bar, as shown in the figure below:

Figure 6-1 Warmer Setup

The main menu includes: Pediatric skin temperature setup, operating modes (Infant Mode Setup / manual
mode setup), LIGHTING SETUP, phototherapy SETUP, WEIGH INFANT, and ADJUST BED HEIGHT.

6.1 Skin Setup

Temperature can be displayed in Fahrenheit or Celsius. The default setup unit is Celsius.During temperature
setup, select the “Infant Radiant Warmer Setup” in the drop-down menu bar. Select “Infant Radiant Warmer
Setup” for temperature setup. There are seven colors displayed, namely green, cyan, red, yellow, white, blue
and purple.
When activated, the warmer will default to the Infant Mode Setup.If previously used, the device will
automatically default to the last setup, regardless of how long the interval is, except for other
parametersbeyond the mode.

6.2 Manual Mode Setup /Infant Mode Setup

6.2.1 Manual Mode display

Power can be set up within an effective range of 0% to 100%. There are seven colors displayed, namely
green,cyan, red, yellow, white, blue and purple.

Page 6-1
 4
2

Figure 6-2 Power parameter display area under manual mode setup

① It is displayed as the Pediatric’s skin temperature measured by the Infant Radiant Warmer’s probe.
In either mode, the temperature will be displayed in the corresponding parameter area on the
touch screen.
② It is displayed as the upper alarm limits of skin temperature. Under manual mode setup, the alarm
accuracy of the warmer can be selected as 0.5°C or 1.0°C , indicating that the difference between
the upper and lower alarm limits of skin temperature and the Pediatric temperature setup value is
0.5°C or 1.0°C.
③ It is displayed as the lower alarm limits of skin temperature. Under manual mode setup, the alarm
accuracy of the warmer can be selected as 0.5°C or 1.0°C, indicating that the difference between
the upper and lower alarm limits of skin temperature and the Pediatric temperature setup value is
0.5°C or 1.0°C.
④ It is displayed as the temperature unit. Temperature can be displayed in Fahrenheit or Celsius. The
default setup unit is Celsius.
⑤ It is displayed as the power setup value. Under manual mode setup, the power setup can be
changed by selecting “Power Setup” in the menu, or by clicking directly on the power parameter
area in the user interface.
⑥ It is displayed as the current value of heating power. ⑤ and ⑥ are an integral whole.

Warning
l The Pediatric shall be continuously monitored while the device is running.
l Keep in mind that when this device is in operation, water loss will increase.
l In case of using phototherapy on this warmer, keep in mind that the radiant heat of the

Page 6-2
 phototherapy apparatus will affect the Pediatric’s skin temperature. Closely monitor the
Pediatric’s skin temperature.
l Continuously monitor the Pediatric’s skin temperature on the skin temperature display. Pay
special attention to skin temperature fluctuations.
l In manual mode, if the initial radiant heat is too much, the Pediatric’s skin temperature may
rise above the target value. Closely observe the Pediatric’s skin temperature while gradually
reducing the heater output.

6.2.2 Infant Mode display

Temperature can be set up within an effective range of 32.0°C to 38.0°C . The accuracy is ±0.1°C. There are
seven colors displayed, namely green, cyan, red, yellow, white, blue and purple.

5
2

Figure 6-3 Temperature parameter display area under Infant Mode Setup

① It is displayed as the Pediatric’s skin temperature measured by the Infant Radiant Warmer’s probe.
In either mode, the temperature will be displayed in the corresponding parameter area on the
touch screen.
② It is displayed as the upper alarm limits of skin temperature. Under Infant Mode Setup, the alarm
accuracy of the warmer can be selected as 0.5°C or 1.0°C, indicating th at the difference between
the upper and lower alarm limits of skin temperature and the Pediatric temperature setup value is
0.5°C or 1.0°C.
③ It is displayed as the lower alarm limits of skin temperature. Under Infant Mode Setup, the alarm
accuracy of the warmer can be selected as 0.5°C or 1.0°C, indicating that the difference between
the upper and lower alarm limits of skin temperature and the Pediatric temperature setup value is
0.5°C
Page 6-3
 or 1.0°C.
④ It is displayed as the temperature unit. Temperature can be displayed in Fahrenheit or Celsius.
Thedefault setup unit is Celsius.
⑤ It is displayed as the Pediatric temperature setup value. Under Infant Mode Setup, the
temperaturesetup can be changed by selecting the “Infant Radiant Warmer Setup” in the menu.
⑥ It is displayed as the current value of heating power.

Note
l The Infant Radiant Warmer can only use the Infant Mode Setup if the probe is connected to the
skin temperature jack.
l When using the baby mode setup, place the temperature probe on the baby's designated position
(such as the abdomen). After the temperature display is stable for about 30 seconds, set the device
temperature.
l When the actual temperature measured by the Infant Radiant Warmer’s probe is lower than the set
temperature, the far-infrared ceramic lamp tube will heat up automatically, and thetemperature
parameter area will indicate “heating”, until the actual temperature in the Infant Radiant Warmer
reaches the set value.

6.2.3 Skin Temperature Alarm example

This alarm is enabled by default when the device is running under the Infant Mode Setup. However, under
themanual mode setup, the skin temperature alarm switch needs to be set to “ON” so that this alarm is
enabled.Under these two mode setup, the accuracy of the skin temperature alarm can be selected as 0.5°C or
1.0°C. Assuming that 0.5°C is selected and the Pediatric temperature is set to 36.5°C, the upper and lower
alarm limits of skin temperature are 37.0°C and 36.0°C, respectively. When the Pediatric temperature is
greater thanor equal to 37.0°C, the alarm prompt of “skin temperature is too high” will be generated.
Similarly, when thePediatric temperature is less than or equal to 36.0°C, the alarm prompt of “skin
temperature is too low” willbe generated. Select 1.0°C, and so on. The upper alarm limit does not exceed
38.5°C.
When an alarm occurs, pay attention to monitor the Pediatric, and check whether the probe is in good contact
withthe Pediatric’s skin. Press the audio paused button to pause the alarm.

Note

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= In all control modes, when the Infant Radiant Warmer’s probe detects abnormally high
temperatures, the device will give an alarm and the heater will turn off automatically. These
alarms do not have a self-reset function. Once an alarm is activated, it can only be reset manually
by pressing the Audio Paused button, even if the alarm condition has been resolved.
= During normal operation of the device, the microprocessor software constantly checks
thefunctions of other alarms. If any part of the circuit fails. the indicator will light up and an alarm
will be given.
= A buzzer alarm will be activated if a microprocessor fault or software error occurs.

Page 6-5
6.3 Operating Mode
Operating mode: Manual mode setup / Infant Mode Setup. Click once to display the manual mode setup,
then the column “Manual Mode Setup” in the main menu will light up. In case of displayed as the Infant
Mode Setup, the column “Infant Mode Setup” in the main menu will light up. After lighting up, the relevant
parameters can be set up.

6.4 LIGHTING SETUP

According to the actual situation, the LIGHTING SETUP of the puncture lamp can be regulated to three
levels: high, medium and low, as shown in Figure 6-4:

Figure 6-4 LIGHTING SETUP

6.5 Phototherapy SETUP

Click to enter the Phototherapy SETUP. According to the actual needs, the brightness of the phototherapy
lamp can be regulated to three levels: high, medium and low. Meanwhile, when the LED is in frequent use,
the service time of the phototherapy lamp will be recorded. If the phototherapy lamp accumulates 10,000
hours of illumination, contact the relevant department in time to conduct phototherapy overhaul. If
damaged,it shall be replaced promptly. As shown in Figure 6-5 below:

Page 6-6
 Figure 6-5 Phototherapy SETUP regulation

6.5.1 Bilirubin irradiance distribution of the phototherapy lamp

Figure 6-6 Bilirubin irradiance distribution of the phototherapy lamp

Page 6-7
6.5.2 Effective Light Spot Distribution on the Bassinet Surface

Effective bilirubin
irradiance distribution
(μW/cm2/nm)

Figure 6-7 Effective light spot distribution on the bassinet surface

Note
Effective surface area and distance from the radiation source will affect the average total
bilirubin irradiance. If the effective surface area is large, the average will be small; if the distance
is far, the average will be small; vice versa.
In order to achieve the best phototherapy effect, the patient must be completely within the
effective surface.
During the light period, protect the patient's eyes and genitals, and prepare eye masks and
diapers.
Turn on the device’s power supply. Turn on the device’s power switch. Then, the device starts to
perform care treatment on the patient.
Care treatment time shall follow the instructions of the attending physician.
During regular examination, the pediatric patients’ undergoinglight irradiation shall not leave the
above light-effective area.

Page 6-8
6.6 WEIGH INFANT
WEIGH INFANT:
The Pediatric shall be placed in the middle of the bassinet. Do not lean stuffed toys or other objects against
the side walls.All leads, IV lines and ventilator catheters shall be secured. The blanket can be stuffed under
the mattress, but not beneath the weighing scale.
Select the “Warmer Setup” in the drop-down menu bar. Select “WEIGH INFANT” (when the weighing probe
isn’t connected, the key of “WEIGH INFANT” is grayed and doesn’t respond to the operation).Make sure that
the mattress platform is in a horizontal position. If the electronic scale is tilted, it will affect the weighing
accuracy.When the mattress is not in a horizontal position; Click “Start” will appear a prompt: “please level
the bed”. In this case, you need to close the baby window and open the bed tilt window to manually level

the bed to properly weigh.

l Click “Start” to enter the countdown state. If there is no nurse operating the device, the device
automatically enters the next step after counting down 8s.

l Electronic scale “return-to-zero”. The device will display “Please pick up the Pediatric”, prompting to

Page 6-9
 pick up the Pediatric. Pick up the Pediatric along with the tubing and conductor attached to the Pediatric.
Make sure that the arms, legs, blankets and clothing are not in contact with the mattress.

l If there is no nurse operating the device, “Please put the Pediatric down” will be displayed on the screen
automatically. Put the Pediatric back on the mattress and hold any lead or tubing attached to the

Pediatric.Use an electronic scale to calculate the Pediatric’s weight and display it on the screen.

Note
l When the display shows “Please put the Pediatric down”, if the Pediatric is not put down, the
weight displayed on the device will be 0g.
l During weighing, the electronic scale will weigh any objects on the weighing scale. Therefore, if
the Pediatric holds the conductor or tubing during placement, the Pediatric’s weight will also
include the weight of the conductor and tubing.
Weight trends:

1) Select the “Warmer Setup” in the drop-down menu bar. Select “Weight Trends”.

Page 6-10
2) Afterentering, a table named “Weight Trends” shows up, where the x-coordinate is the number of days
(0 to 7 days), and the y-coordinateis the weight. If the Pediatric actually weighs less than 1kg, the
maximum y-coordinate will be 1kg. If the Pediatric actually weighs greater than 1kg,the y-coordinate will
automatically adjust the coordinate scale so that the trend can be fully displayed (Note: The maximum
y-coordinate is not the actual weight. It will take an integral value in kg that is greater than the weight.
For instance, if the maximum weight is 5.4, the maximum y-coordinate will be 6.). Upon the expiration
of 7 days, the data from 7 days ago will automatically be deleted in cycle, leaving only the data from the
last 7 days. You can also click “Clear Records” to restart a new round of measurement.If the body
weight is measured multiple times on the day, only the maximum weight value of the day will be
recorded.The trend chart also displays the daily specific measurement values.

6.7 ADJUST BED HEIGHT

The bassinet height may be regulated to facilitate the use of nursing staff. Select the “Warmer Setup” in the
drop-down menu bar to select “ADJUST BED HEIGHT”, then the “ADJUST BED HEIGHT” display window pops
up. Click the “ON” or “OFF” button first. Only when the Change button in the interface is ON

Page 6-11
can bassinet height be regulable. Click the UP / DOWN button at the upper right corner of the window to
complete the lifting control of the bassinet height. Use the pedal button for bassinet height on either side of
the Infant Radiant Warmer to lift and lower the bassinet. The bassinet height can be regulated low enough
and high enough.
(1) Select the “Warmer Setup” in the drop-down menu bar to select “ADJUST BED HEIGHT”, then the
“ADJUST BED HEIGHT” display window pops up. Click the “ON” of “OFF” button first. Only when the
Change button in the interface is ON can bassinet height be regulable.

Warning
l During the lifting process, do not perform any other operations on the Infant Radiant Warmer
and the Pediatric on the bassinet.

Figure 6-8 ADJUST BED HEIGHT

(2) The ADJUST BED HEIGHT may also be realized by pedal lifting on either side of bassinet. The lifting

effect is same as the “ADJUST BED HEIGHT "set in the menu. Press the button " "to raise the

bassinet and the button " " to lower.

Figure 6-9 pedals lifting on either side of bassinet

Page 6-12
 Chapter 7 Bassinet Tilt
Through the interface operation, front and rear ends of the bassinet can be tilted according to user
requirements. The maximum tilting angle is 12°. Select “ADJ BED TILT” in the drop-down menu bar at the
bottom of the operation interface, then the setup window pops up. The tilt angle value will be displayed in
realtime during the setup process. As shown in Figure 7-1:
Ø Select “+5°”: It indicates that the bassinet front end can be tilted to 5°;
Ø Select “-5°”: It indicates that the bassinet rear end can be tilted to 5°;
Ø When the tilt angle of the bassinet set by the user is other values in the tilt range, it can be

regulatedby “ ” and “ ”. “ ” indicates to select the horizontal state.

Figure 7-1 Bassinet inclination regulation

Note

l During bassinet tilting, make sure that other objects around are not caught by the bassinet.
l Do not place the baby on the bed when adjusting the tilt because the baby may slip.
l Do not exert unnecessary excessive force on the mattress platform.
l Always pay attention to the position of the mattress platform for proper temperature control. The
total radiant heat reaching the mattress will vary depending on whether the mattress is horizontal
or inclined.Meanwhile, some parts of the patient’s body will be closer to the heater and more
infrared radiation heat will be absorbed, affecting the patient’s body temperature.Therefore, the
frequency of examination on these parts of the patient shall be
increased.

Page 7-1
 Chapter 8 Apgar Setup
Apgar alarm is used for monitoring the timing alarms, including timer mode, counter setup, countdown timer
setup and timer reset. After startup, the Infant Radiant Warmer is in count alarm mode by default.

8.1 Apgar Count Alarm

The Apgar count alarm refers to auto-increment of the timer. The alarm will be triggered at the time
ofarriving at the time point. The specific interface is shown in below:
(1) In “Apgar Count Alarm” mode, click the “Apgar Setup” at the bottom of the menu bar. Select “Counter
Setup” in the pop-up menu “Apgar Setup”. Set 10 time points.The time at each time point can be set up
according to the actual needs.
(2) After setup, press “ ” key to exit.

Figure 8-1 Counter Setup

8.2 Apgar Countdown Alarm

The Apgar countdown alarm refers to timer auto-decrement from the set time. The alarm will be triggered at
the time of arriving at the time point. The specific interface is shown in below:
(1) In “Apgar Countdown Alarm” mode, click the “Apgar Setup” at the bottom of the menu bar. Select
“Countdown Timer” to add the time points in the pop-up menu “Apgar Setup”. Set 10 time points.The
time at each time point can be set up according to the actual needs.
(2) After setup, press “ ” key to exit.

Page 8-1
 Figure 8-2 Countdown Timer Setup

Note

l The Infant Radiant Warmer defaults to Apgar count alarm, which can be switched to Apgar
countdown alarm through the timer switch.
l The timing alarm can be canceled by timer reset.

Page 8-2
 Chapter 9 ECG Monitoring

9.1 Definition of ECG Monitoring

The ECG produces a continuous electrical activity in the Pediatric’s heart and displays it in waveforms and
values on the Infant Radiant Warmer to accurately assess the Pediatric’s current physiological status.
Consequently, it shall ensure that the ECG cable is properly connected so that correct measurements and
normal ECG waveforms can be obtained.
Pediatric cable consists of two parts:
l Mains connected to the warmer
l Lead device connected to the Pediatric
This device performs ECG monitoring through the C31 module (see Figure 9-1) and is fitted with three-lead
wires for monitoring.You can click the ECG waveform in the waveform area and change the lead name to
select the lead to be monitored.
Monitoring display parameters: HR is one of the alarm parameters.

ECG cable interface

Figure 9-1 C31 module

9.2 Precautions for ECG Monitoring

Warning

Page 9-1
l When using this Infant Radiant Warmer for ECG signal monitoring, the Tende-provided ECG leads
must be used.

l Do not expose the device to X-rays or strong magnetic fields (MRI).

l When you connect the electrode or Pediatric cable, make sure that the Pediatric is absolutely not
in contact with any other conductive parts or with the ground. In particular, make sure that all
ECG electrodes, including the neutral electrode, are attached to the Pediatric to avoid contacting
the conductive parts or ground.

Page 9-2
 Note

l Interference and ESU interference from an ungrounded Infant Radiant Warmer near anPediatric
may cause waveform problems. Electric field strengths in excess of 1V/m may cause measurement
errors at various frequencies if operated in accordance with the conditions specified in EN 60601-
1-2 (resistance to radiation of 3V/m). Therefore, it is not recommended to
use electrical radiation equipment in the area close to ECG / RESP measurement.

9.3 Monitoring Steps

9.3.1 Preparation
Before placing the electrodes, prepare the Pediatric’s skin properly first:
(1) Since skin is a poor conductor, it is very important to prepare the Pediatric’s skin to obtain good
contactbetween the electrode and the skin.
(2) Where necessary, shave the body hair at the electrode placement.
(3) Wash the skin thoroughly with soap and water until the skin is completely dry (do not use ether
andabsolute alcohol, as they will increase the skin’s impedance).
(4) Gently dry the skin to increase the capillary blood flow to the tissue, and remove dead skin and grease
toimprove the conductivity on the electrode pasting site.
(5) Install the spring clip before placing the electrode.
(6) Place the electrode on the Pediatric. If using an electrode that does not contain conductive paste,
applythe conductive paste before placement.
(7) Connect the electrode lead to the Pediatric cable.

Warning

l Check whether the ECG electrode patch irritates the skin daily.If there are signs of allergies,
replace the electrode or change the position within every 24h.
l Prior to monitoring, check whether the lead is normal. After unplugging the ECG cable, the
prompt message “Sensor is off”will be displayed on the screen.
l Do not use electrode patches in areas where the skin is inflamed or ulcerated.Electrode patches
are forbidden to be used in the patient allergic to electrode conducting medium.

Note

l Used electrodes must be recycled or disposed of properly to protect the environment.

Page 9-3
9.3.2 Installing the ECG Lead

1) ECGmonitoring electrode placement

Note

l The following table lists the names of leads in European and American standards, respectively
(the leads are expressed in RA, LA and LL in the U.S. standard, and expressed in R, L and F in
the European standards).

USA Europe

Lead name Color Lead name Color

RA White R Red
LA Black L Yellow

LL Red F Green

2) Standard three-lead electrode placement

R (right arm) position: right under the

Right arm Left arm collarbone, near the right shoulder
L (left arm) position: right under the
collarbone, near the left shoulder
F (left leg) position: on the left lower
abdomen

Left leg

Figure 9-2 Three-lead electrode placement diagram

Note
l To ensure the safety of the Pediatric, all the leads must be connected to the Pediatric.
l If the electrode is attached correctly and the ECG waveform is not accurate, replace the lead.
l Disturbances and ESU interference from ungrounded equipment near Pediatrics may cause
waveform problems.
3) ECG leads recommended for surgical Pediatrics
Warning

l When using ES equipment, place the ECG electrode in the middle of the ES ground plate and the
electrosurgical knife to avoid burns. Cables for the ES equipment shall not be intertwined with the
ECG cables.
l When using ES equipment, do not place the electrode near the ground plate of the ES
equipment, otherwise there will be a significant amount of interference on the ECG signal.

Page 9-4
The placement of the ECG leads depends on the type of surgery performed. For example, the electrode can
be placed on the side of the chest or on the back for thoracotomy. In the operating room, artifacts may
sometimes affect the ECG waveform due to the use of ES equipment. To help reduce artifacts, place the
electrodes on the left and right shoulders, and on the left and right sides of the abdomen. Avoid placing the
electrodes on the upper arms. Otherwise, the ECG wave would become very small.
Characteristics of a good signal:
n Tall and narrow without any incisura.
n R wave is tall and lies completely above or below the baseline.
n Pacing signal is not greater than the height of R wave.
n T wave is less than 1/3 of the R wave height.
n P wave shall be much smaller than T wave.
In order to obtain a 1mV calibration ECG wave, ECG calibration shall be performed, and the screen prompts
“ECG calibration ...”.

Figure 9-3 Standard ECG waveform

9.4 ECG Screen Hotkeys

① ② ③ ④ ⑤ ⑥

Figure 9-4 ECG screen hotkeys

① ECG lead name:

The Infant Radiant Warmer, with 3-lead monitoring, is available with the lead names of“I”, “II” and “III”.
② ECG wave gain:
It is used for regulating the amplitude of the ECG wave.It is allowed to choose the gain of each calculation
channel, which is divided into ×0.125, ×0.25, ×0.5, ×1, ×2 , ×4 and automatic mode. The device automatically
regulates the gain in automatic mode. 1mv scale is given on the right side of each ECG waveform. The height
of 1mv scale is proportional to the amplitude.

Page 9-5
③ Filtering mode:
Cleaner or more accuratewaveform can be obtained by filtering. There are three optional filtering modes.
Unfiltered ECG waves are displayed in diagnosis mode; monitoring mode may filter out artifacts that cause
false alarms; surgical procedures in the operating room can reduce artifacts and interference from the ES
equipment.
④ 1mv scale rod:
Display the scale rod with the gain height.
⑤ ECG value:
Display the current measured ECG value.
⑥ Upper and lower limits for the lower limit of HR:
Display the upper and lower alarm limits for the lower limit of the HR alarm setup in the ECG setup.

9.5 ECG Setup

9.5.1 Set Lead Name

In the Standard interface, when 3 Leads is selected as the lead type, only one ECG wave can be displayed.
1) Select the first ECG wave to enter the “ECG Wave” menu → “Lead Name”; select the lead for key
monitoring, such lead as “II”.

9.5.2 Set Calculate Lead

3 Leads: Lead II is locked; no other options are provided. Later, it will change of “lead name”, but still cannot
be set.

9.5.3 Setup the HR Source

(a) Click “ECG Waveform Area” or “ECG Parameter Area”. In the pop-up menu, select “HR
Source”→“ECG”, “SPO2” or “Automatic”.
(b) After setup, press the “ ” key to exit.

9.5.4 Setup the Filtering Mode

(1) Click “ECG Waveform Area”. In the pop-up menu, select “Filtering Mode”→“Diagnosis”,
“Monitoring”or “Surgery”.
(2) After setup, press the “ ” key to exit.

Warning
l The device can only provide unprocessed real signals when it is in diagnosis mode. In
“Monitoring” and “Surgery” filtering modes, the ECG waveform will have different degrees of
distortion.AWRR analysis results may also be partially affected in surgery mode.Therefore, it is

Page 9-6
recommended to use the diagnosis mode for Pediatric monitoring when interference is small.

Page 9-7
9.5.5 Set Notch Filter

Notch filter can inhibit the 50Hz or 60Hz frequency component in the signals acquired. When the filter mode
is not Diagnosis, the system will turn on Notch Filter automatically; when the filter mode is Diagnosis, Notch
Filter can be turned on or off as needed.
1) Select the ECG parameter area or Select "Physiological Setup" to enter the Setup menu.

2) Set “Notch Filter” as follows:

“Strong”: Select it when the wave jitters frequently (e.g., the wave has
burrs).“Weak”: Select it when the wave jitters infrequently.
“Off”: Notching will not be performed.
3) Enter“User Maintain” → “Notch Filter”.

4) User can select “50Hz” or “60Hz” according to the power supply frequency.

9.5.6 Setup the Gain

(a) Select“ECG Waveform”. In the pop-up menu, select “Gain”→ “×0. 125”, “×0.25”, “×0.5”, “×1”, “×2” ,
“×4” or “Automatic”.
(b) After setup, press the “ ” key to exit.

Note
l When the input signal is too large, the peak may be truncated. In this case, the user canmanually
change the gain waveform of the ECG waveform by referring to the actual waveform
to avoid incomplete waveform display.

9.6 ECG self-learn

In the case of ECG monitoring, if the patient's ECG template changes significantly, you may need to manually
initiate an ECG self-learning. Changes in the ECG template may result in inaccurate heart rate values.
Start self-learning:
Select "Physiological Setup" → "ECG Setup" → "ECG Self-learning" in the ECG parameter area or the lowermenu
bar.
Warning
l Start ECG self-learning during normal rhythm and when the ECG signal is relatively noise
free.

Page 9-8
 Chapter 10 NIBP Monitoring

10.1 Overview
1) Oscillation method is applied to the NIBP measurement;
2) For Pediatrics;
3) Measurement mode: Manual, automatic. Each mode shows NS, NM and ND.
4) The BP values measured by this device are equivalent to the values measured by using the invasive
method. The error complies with the requirements of IEC60601-1-30. The brachial artery is selected for
verification in the clinical trials using the invasive method.

Warning

l The NIBP measurement cannot be carried out in Pediatrics with sickle cell disease and any
damaged or expected damage to the skin.
l For Pediatrics with severe coagulation disorders, decide whether to perform automatic NIBP
measurement based on the clinical evaluationbecause of the risk of hematoma at the rubbing of
the limbs and cuffs.

10.2 NIBP Monitoring

10.2.1 NIBP Measurement

Warning
l Do not install cuffs on limbs with IV fluids or catheters. During inflation of the cuff, injury may
occur around the catheter when the infusion is slowed or blocked.
l The inflation tube that connects the BP cuff to the Infant Radiant Warmer shall be patented and
not tangled.

(1) Insert the inflation tube into the BP cuff interface of the Infant Radiant Warmer. Turn on the power
supply of the Infant Radiant Warmer.
(2) Apply a BP cuff to the Pediatric’s upper arm or thigh according to the following method, as shown in
Figure 9-1:
n Confirm that the cuff is fully deflated
n Use an appropriately sized cuff for the Pediatric, ensuring that the mark φ is right above the
appropriate artery.Make sure that the cuff is not too tight around the limb, otherwise it may cause
discoloration or even ischemic distal limbs.

Page 10-1
 Figure 10-1 Cuff in use

Note
l The width of the cuff shall be 50% of the limb circumference, or 2/3 of the length of the upper arm.
The inflatable portion of the cuff shall be long enough to encircle 50% to 80% of the limbs.
Unsuitable cuffs will produce erroneous readings. If there is a problem with the cuff size, use a
larger cuff to reduce the error.

Reusable cuffs for Pediatrics:

Patient Limb circumference Cuff width Length of inflation tube

type
Pediatric 6~11cm 5cm
2m
Pediatric 10~19cm 8cm

Disposable cuffs for Pediatrics:

Size Limb circumference Cuff width Length of inflation tube

Pediatric 1 3.0~5.5cm 2.6cm

Pediatric2 4.0~7.6cm 3.7cm

Pediatric3 5.6~10.6cm 4.5cm 2m

Pediatric4 7.0~12.8cm 5.3cm

Pediatric5 8.9~15.0cm 6.0cm

n Check that the edge of the cuff falls within the range marked <->. If not, switch to a more
suitablecuff.
(3) Connect cuff to inflation tube. The limb used for manometry shall be placed on the same level as the

Page 10-2
 Pediatric’s heart. If it is not possible, the following corrections shall be used to correct the measurements:
n If the cuff is above the level of the heart, add 0.75mmHg (0.10kPa) to the displayed value for
thedifference per centimeter.
n If the cuff is below the level of the heart, the difference per centimeter shall be reduced
by0.75mmHg (0.10kPa) on the displayed value.
(4) Select the measurement mode in the NIBP menu. For details, see the “Prompt for Operation” below.
(5) Click the NIBP parameter area. In the pop-up menu “NIBP Setup”, select the “Pre-inflation Value” to set
the appropriate pre-inflation value. Start to inflate for pressure measurement.

10.2.2 NIBP measurement method

Select the NIBP parameter area or select “physiological setup”to enter the setup menu.
10.2.2.1 Start Measurement
(a) Start the automatic Measurement

Select the “Interval”: from 1 minute to 480 minutes (1min(2min(3min(4 min(5 min(10 min(15 min(

30 min(60 min(90min (120 min(180 min(240 min(480 min)

(b) Start the Manual Measurement

Enter the setup menu→“Measure Mode”→ “Manual”. Whether to start the NIBP measure depends on the
user’s need.
(c) Start the Continual Measurement
Select the NIBP parameter area to enter “NIBP Setup”→ “Continual Measure”, and then start the 5min
measurement continuously.

Warning

l There maybe risks when the air bag is inflated excessively for a long time.
l If the NIBP time in automatic mode is too long, the limb rubbing against the cuff may be
accompanied by purpura, ischemia and nerve injury. During Pediatric monitoring, always check the
color, warmth and sensitivity of the distal limbs. Once any abnormality is observed, place the cuff in
another place or immediately stop the NIBP measurement.

Warning
l If you are suspicious of reading accuracy, check the Pediatric’s vital signs in the same way before
checking the Infant Radiant Warmer’s functions.
l If liquid splashes on the equipment or accessories, especially when it is possible for liquids to
enter the tubing or Infant Radiant Warmer, contact your hospital’s service department.

10.2.3 NIBP Display

Page 10-3
 3 4 9

5
10

1 6

8 7

Figure 10-2 NIBP parameter display area

Method of measurement: manual measurement,

1 NS value 2
automatic measurement
3 Measurement time 4 Measurement mode: neonates, Pediatrics
5 Pressure unit: mmHgor kPa 6 Display the NS alarm limits

7 NM value 8 ND value

9 PR alarm display 10 English abbreviation for systolic pressure

10.2.4 Measurement Limits

Depending on the Pediatric’s condition, there are some limitations to the measurement by oscillometry. This
measurement is looking for regular pulse waves generated by arterial pressure. In situations where the
Pediatric’s condition makes this type of detection difficult, the measurements become unreliable and the
duration of pressure measurement increases as well. The user shall be aware that the following conditions
can interfere with the measurement method, making the pressure measurement unreliable or the duration
of pressure measurementelongated. In this case, the Pediatric’s condition will make the measurement
impossible.
1) Pediatric movement
If the Pediatric is moving, shivering or cramping, the measurement will be unreliable or even impossible, as
these conditions may interfere with the detection of arterial pressure pulsations and the duration of
pressure measurement will be extended.
2) Arrhythmia
If the Pediatric shows irregular heartbeat caused by arrhythmia, the measurement will be unreliable or even
impossible, and the duration of pressure measurement will be extended accordingly.
3) Heart-lung machine
If the Pediatric is connected to a heart-lung machine, it will be impossible for measurement.
4) Pressure changes

Page 10-4
If, at some point, the arterial pressure pulsation is being analyzed to obtain a measurement, at which point
the Pediatric’s blood pressure changes rapidly, the measurement will not be reliable or even impossible.

Page 10-5
5) Severe shock
If the Pediatric is in severe shock or hypothermia, manometry will not be reliable, since a decrease in
bloodflow to the periphery will result in a decrease in arterial pulsation.
6) Extreme heart rate
BP measurement is not available in case of HR below 40bpm(heart beats /min) and above 240bpm(heart beats
/min).
7) Fat Pediatric
The thick fat layer around one limb causes the oscillations from the arteries to be damped so that they cannot
reach the cuff. Accuracy is lower than normal.

10.2.5 NIBP Setup

(1) Set the interval

a) Click the “NIBPParameter Area”. In the pop-up menu “NIBP Setup”, select “Interval”, select “Manual” or
“1min”, “2min”, “3min”, “4min”, “5min”, “10min”, “15min”, “30min”, “60min”, “90min”, “120min”,
“180min”, “240min”, “480min”.
(1) Manual: Under manual mode setup, NIBP measurement is performed manually once
measurement is required.
(2) Automatic: In automatic mode, the Infant Radiant Warmer automatically and repeatedly performs
NIBP measurements at set intervals.
b) After setup, press the “ ” key to exit.
(2) Set the pressure unit
a) Click the “NIBPParameter Area”. In the pop-up menu “NIBP Setup”, select“Pressure Unit”→ Select
“mmHg” or “kPa”.
b) After setup, press the “ ” key to exit.
(3) Set the pre-inflation value
a) Click the “NIBPParameter Area”. In the pop-up menu “NIBP Setup”, select“Pre-inflation Value”→ Set a
suitable pre-inflation value. If the previous patient type is selected as "neonate", four options will be
provided, namely: 60, 80, 100, and 120, with a default value of 100 mmHg; if the previous patient type
is "pediatric" , will provide seven options, respectively: 80, 100, 120, 140, 160, 180, 200; default value:
120mmHg;
b) After setup, press the “ ” key to exit.

10.2.6 Assistance in Venipuncture

Inflate the NIBP cuff to a pressure approximate to the diastolic pressure to block the vein vessel and assist
inthe completion of venipuncture.

1) Select the NIBP parameter area to enter “NIBP Setup”→ “Cuff Pressure” and then select an

appropriatepressure value.
2) Select “Venipuncture Start”, then the key change to “Venipuncture Stop”.
Page 10-6
3) Puncture the vein and take the blood sample.

4) Press the “NIBP MEASUREMENT” key or the relevant shortcut key to deflate the cuff. If you fail to doso,

the cuff will be auto deflated after a set time.

In the venipuncture process, the NIBP parameter area will display the cuff pressure and remaining time of
venipuncture.

10.3 NIBP Reset

Click the “NIBP Parameter Area”. In the pop-up menu “NIBP Setup”, select“Reset”. Reset can restore the
pump’s inflation value to its original setup. When the blood pressure pump is not functioning properly,
you can check the blood pressure pump by reset and automatically recover the abnormalities caused by
unexpected causes.

Page 10-7
 Chapter 11 SpO2 Monitoring

11.1 Definition of SpO2 Monitoring

The SpO2 plethysmographic parameter measures arterial oxygen saturation, which is the percentage of total
oxyhemoglobin. For instance, in RBCs in arterial blood, in the case that a total of 97% of the hemoglobin
molecules are bound to oxygen, the blood has a SpO2 of 97%. The SpO2 reading on the touch screen shall be
97%. The SpO2 value shows the percentage of oxyhemoglobin molecules that form oxyhemoglobin. The SpO2
plethysmographic parameters also provide PR signals and plethysmographic waves.

11.1.1 Measuring Principle of SpO2 Plethysmography Parameter

Oxygen saturation is measured by dual wavelength pulsation, which is a continuous and noninvasive method
for determining the saturation of hemoglobin oxygenation.It measures how much of the light emitted from
one side of the sensor’s light source passes through Pediatric tissue (such as finger or ear) and reaches the
receiver on the other side.
The amount of light that passes through depends on many factors, most of which are constant. However,
one of these factors, arterial blood flow, changes over time because it is pulsatile. By measuring the light
absorbedduring pulsations, it is possible to obtain arterial blood oxygen saturation.

Warning
l If there is carboxyhemoglobin, methemoglobin or dye-diluted chemicals, the SpO2 value will be
biased.

11.1.2 Identifying the SpO2 Type

The Infant Radiant Warmer is shipped from the factory with the type of SpO2 configured and can be identified
from the back sidepanel of the Infant Radiant Warmer:
l Nellcor SpO2: The Infant Radiant Warmer’s back side panel is marked with not only the SpO2
identification, but also Nellcor.
l Masimo SpO2: The Infant Radiant Warmer’s back side panel is marked with not only the SpO2
identification, but alsoMasimo.
= Wavelength that can be measured by the sensor of Masimo SpO2 module: 660nm for red light; 905nm
forinfrared light.
= Wavelength that can be measured by the sensor of Nellcor SpO2 module: 660nmfor red light; 900nm
forinfrared light.
The information on the wavelength range and maximum optical output power of different sensors is
particularly useful to clinicians, such as photodynamic therapy.
The maximum optical output power of the sensor is less than 15mW.

Page 11-1
 Warning
l Connect the Infant Radiant Warmer to the SpO2 probe correctly. If the incorrect probe is used,
the SpO2 parameter cannot be measured normally.

11.1.3 SpO2 Monitoring

Warning
l The cables of the ES equipment cannot be twisted with the sensor cables.
l Do not place the sensor on a limb with an artery catheter or IV tube.

Note
l During BP measurement, do not place the SpO2 probe and the BP cuff on the same limb, as
blood flow occlusion during BP measurement affects the SpO2 reading.

11.2 Precautions for SpO2 / Pulse Monitoring

Warning

l Before starting monitoring, check whether the sensor cable is normal. When the SpO2 sensor
cable is unplugged from the socket, the display shows a “Sensor Off” error message and an
audible alarm is triggered at the same time.
l If the sensor package or sensor has signs of damage, do not use this SpO2 sensor and return it to
the manufacturer.
l Continuous and prolonged monitoring may increase the risk of unexpected changes in skin
characteristics such as abnormal sensitivity, redness, blistering or compression necrosis,
especially in Pediatrics. Special attention shall be paid to checking the placement of the sensor
based on changes in the quality of the skin, correct alignment of the optical path, and attachment
methods. When the Pediatric is under continuous long-term care, the health care provider shall
check the location of the sensor every 2 hours and change the location of the sensor when the
quality of the skin declines. Depending on the status of individual Pediatrics, more frequent
examinations may be required.
l Setup SpO2 upper alarm limit to 100% is equal to disconnecting upper limit alarm. Hyperoxia
levels can cause preterm Pediatrics to develop crystalline fibrous tissue disease. Therefore, the
upper alarm limit of oxygen saturation must be carefully chosen according to accepted clinical
practice.

Page 11-2
 Note

l Make sure that the nails cover the light inside the probe. The probe cable shall be placed on the
back of the hand.
l The SpO2 value is always displayed in a fixed position.
l The SpO2 waveform is out of proportion with the pulse volume.
l Hemoglobin may falsely increase readings. The degree of increase is approximately equal to
the current amount of hemoglobin. Dyes and other dye-containing substances can alter the color
of the usual arteries and can also lead to erroneous increase in readings.
l Some of the Nellcor SpO2 sensorscontain natural rubber latex that may cause an allergic reaction.
l Masimo SpO2 sensorsdo not contain latex.

11.3 Monitoring Steps

Warning

l According to the Infant Radiant Warmer and the SpO2 probe used with it, select the appropriate
placement method, which is particularly important for the placement of the Pediatric’s SpO2
probe.

(1) SpO2 plethysmographic measurement is shown in Figure 11-1:

Attach the sensor to an appropriate position of the Pediatric’s finger;
Connect the sensor cable to the SpO2 jack.

Figure 11-1 Sensor placement

(2) Pediatric SpO2 plethysmographic measurement:

The SpO2 plethysmographic measurement in Pediatrics is basically the same as in adults. The Pediatric SpO2
probe and its placement method are described below.
= Pediatric SpO2 Probe
The Pediatric SPO2 probe consists of a Y-shaped SpO2 probe and an Pediatric SpO2 probe sheath.The LED
end and PD end of the Y-shaped SpO2 probe are embedded in the upper and lower grooves of the Pediatric
SpO2 probe sheath, respectively (as shown in Figure 11-2). The embedded Pediatric SpO2 probe is shown in
Figure 11-3.

Page 11-3
 Y-shaped SpO2 probe Pediatric SpO2 Probe Sheath

Figure 11-2 Pediatric SpO2 Probe (1)

Figure 11-3 Pediatric SpO2 Probe (2)

= Pediatric SpO2 Probe Placement

Pinch the SpO2 probe to thePediatric’s hand or foot (as shown in Figure 11-4). Hold the SpO2 probe. Pull the
strap and place the V-shaped edge on one side of the strap into the V-shaped slot on the corresponding side
of the strap. Extend the strap (about 20mm) as appropriate and attach the V-shaped edge into the V-shaped
groove on the other side of the sheath, and then loosen the strap. In the case of V-shaped edges on both
sides of the strap embedded into the V-shaped grooves on both sides of the sheath, insert the strap into the
first latch to lock the strap. If the strap is too long, fit it into the second latch. The SpO2 probe must be
positioned in this way so that the optoelectronic components are in the correct positions. Meanwhile, be

careful not to pull the strap too long, otherwise it will result in inaccurate measurements and may severely
clog up blood circulation.

Figure 11-4 Pediatric SpO2 probe placement

Note

Page 11-4
l If the test site and the probe cannot be positioned accurately, the SpO2 reading may not be
accurate, even the pulse wave cannot be searched for SpO2 monitoring. In this case, repositioning
is required.
l Excessive movement of the measurement site may result in inaccurate measurements. At this
time, the Pediatricshall be quiet or replace the measurement site to reduce the impact of
excessive movement on the measurement.

Page 11-5
 Warning

l During the continuous monitoring for a long time, check the peripheral circulation and skin
condition of the measurement site every 2 hours or so. If any adverse changes are found, change
the measurement site in time.
l During the continuous monitoring for a long time, check the position of the probe periodically to
avoid changing the position of the probe due to movement and other factors, which will affect
the accuracy of the measurement.

11.4 Measurement Limits

During operation, the following factors may affect the accuracy of the SpO2 measurement:
(1) High-frequency radio interference, including the interferences generated by the host itself or the
interferences from an electrosurgical Infant Radiant Warmer connected to the device.
(2) Do not use an oximeter or SpO2 sensor during the MRI scan. The induced current may cause burns.
(3) Intravenous dye.
(4) Pediatrics move too frequently.
(5) External light radiation.
(6) Improper sensor installation or improper contact with the object.
(7) Sensor temperature (the optimal temperature shall be at 28°Cto 42°C ).
(8) Place thesensor on a limb with a BP cuff, an arterial duct or intraluminal tubing.
(9) Concentration of non-functional hemoglobin such as carboxyhemoglobin (COHb) and
methemoglobin(MetHb).
(10) SpO2 is too low.
(11) Poor perfusion of the test site.
(12) Shock, anemia, hypothermia and the application of vasoconstrictors may reduce arterial blood flow to
an unmeasurable level.
(13) The measurement also depends on the absorption of oxyhemoglobin and reduced hemoglobin for light
of a particular wavelength. If other substances that absorb the same wavelength exist, they will cause
false or low SpO2 values to be measured, such as carbonated hemoglobin, methemoglobin, methylene
blue androuge indigo.
(14) It is recommended to use the SpO2 probe described in the accessories.

11.5 SpO2 Setup

11.5.1 Setup the Signal Indication

The signal indication indicates that a sign of signal acquisition shows up under the SpO2 waveform when the

Page 11-6
signal is enabled. This sign mainly reflects the quality of the signal during the acquisition. At the time of
shutdown, the sign of signal acquisition below the SpO2 waveform disappears (this function is only valid for

Page 11-7
Masimo SpO2). The setup steps are as follows:
(1) Click the “SpO2 Parameter Area”. In the pop-up menu “SpO2 Setup”, select “Signal Indication”→ Select
“ON” or “OFF”.
(2) After setup, press the “ ” key to exit.

11.5.2 Smart Alarm

1) Select the SpO2 parameter area to enter “SpO2 Setup” → “Sat second” (Saturation

Seconds).2) Select “10”, “25”, “50”, “100” or “Not Allowed”.

Note: this function is available for NELLCOR SpO2 only.

The smart alarm is designed to reduce false alarms and keep the clinician informed of the SpO2 changes
more accurately and timely. For example, if you set “Sat second” to “50” and the upper and lower alarm limit
of NELLCOR SpO2 respectively to 97% and 90%, maintain the measured SpO2 value at 80% for 3s and then
reduce it to 78% for 2s, the Monitor will trigger the alarm sound and indicator 5s after the SpO2 value goes
beyond the alarm limit and the circle beside the SpO2 value will return to the origin.
Calculation method:
Percentage points × seconds = Sat second (integer)
The calculated Sat second is displayed as follows:
% SpO2 Seconds Sat second
!90%-80%"* 3 =30

!90%-78%"* 2 =24
Total Sat second = 54

Figure 11-5 Example Diagram

In the above Sat second example:

About 4.9s later, the Monitor will report a Sat second alarm because you’ve set “Sat second” to “50”,
smaller than 54.
The SpO2 value may fluctuate in seconds rather than remain unchanged. The patient’s SpO2 value usually

Page 11-8
fluctuates within the alarm limit and sometimes goes beyond the alarm limit discontinuously. The
device

Page 11-9
 will accumulate the positive and negative percentage points until the set value of “Sat second” is
reachedor the patient’s SpO2 value remains beyond the alarm limit.

11.5.3 Setup the Pulse Sound

The pulse sound indicates that it is able to prompt PULSE sound when the pulse sound is turned on. When
it is turned off, there is no prompt of PULSE sound (this function is only valid for Masimo SpO2). The setup
steps are as follows:
(1) Click the “SpO2 Parameter Area”. In the pop-up menu “SpO2 Setup”, select “Pulse Sound”→ Select “ON”
or “OFF”.
(2) After setup, press the “ ” key to exit.

11.5.4 Setup the rapid SpO2

Rapid SpO2 refers to the rapid measurement of SpO2 with an average time of 2s when rapid SpO2 is activated
(this function is only valid for Masimo SpO2).This functional module is always unavailable. Rapid SpO2 can
only be set to “ON” or “OFF” by selecting the average time.When the average time is selected as “2-4s”or “4-
6s”, rapid SpO2 is automatically set to “ON”. After the set average time exceeds 8s, rapid SpO2 is
automatically set to “OFF”.

11.5.5 Setup the Average Time

Average time means that the SpO2 value displayed on the screen is the result of averaging the data collected
over a period of time.The shorter the average time, the faster Infant Radiant Warmer responds when the
Pediatric’s SpO2 value changes,but the less accurate the measurement is. Conversely, the longer the average
time, the slower the Infant Radiant Warmer responds when the Pediatric’s SpO2 value changes, but the more
accurate the measurement is.When monitoring the critically ill Pediatrics, setup a smaller average time to
facilitate the timely analysis of the disease. The doctor needs to set up depending on the situation (this
function is only valid for Masimo SpO2). The setup steps are as follows:
(1) Click the “SpO2 Parameter Area”. In the pop-up menu “SpO2 Setup”, select“Average Time”→ Select “2-
4s”, “4-6s”, “8s”, “10s”, “12s”, “14s” or “16s”.
(2) After setup, press the “ ” key to exit.

11.5.6 Setup the Calculation Sensitivity

Calculation sensitivity is divided into: normal, high sensitivity and APOD.Set “high sensitivity” to be the
highest sensitivity according to the level of distinction. For typical Pediatric monitoring, “normal” sensitivity
shall apply. Due to skin moistening, strenuous exercise or other reasons, the probe may be separated from
the Pediatric’s body. In this case, “APOD” shall apply. If the Pediatric perfusion level is extremely low, “high
sensitivity” sensitivity shall apply to improve sensitivity (this function is only valid for Masimo SpO2). The
setup steps are as follows:

Page 11-10
(1) Click the “SpO2 Parameter Area”. In the pop-up menu “SpO2 Setup”, select“Calculation Sensitivity”→
Select “Normal”, “High Sensitivity”or “APOD”.

Page 11-11
(2) After setup, press the “ ” key to exit.

11.5.7 NIBP Same Side

Set “NIBP Same Side”:

1) Select the SpO2 parameter area to enter “SpO2 Setup”.

2) Select “NIBP Same Side” to switch to“On”.

If you do not select “On” the weak perfusion caused by NIBP measurement will lead to inaccurate SpO2
measurement or trigger a physiological SpO2 alarm when the NIBP measurement and SpO2 measurement are
performed on the same limb.

11.6 Masimo Information

Masimo patents

One or more of the following U.S. patents shall be included: RE38,492, RE38,476, 6,850)787, 6,826,419,

6,816,741, 6,699,194, 6,684,090, 6,658,276, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,584,336,

6,501,975, 6,463,311, 6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,206,830, 6,157,830, 6,067,
462, 6,011,986, 6,002,952, 5,919,134, 5,823,950, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505,
5,482,036, and one or more patents referred to by international general patents or
www.masimo.com/patents.For the products with the functions of Sat share®, the U.S. patent 6,770,028
shall also be included. Other patents are pending.
Other information
@2006 Masimo Corporation, Masimo, Radical, Discrete Saturation Transform, DST, Sat share, SET, LNOP,
LNCS and Lop are Masimo Corporation’s federal register trademarks.
Ardent, Radical screen, signal IQ, Fast Sat, fast Startand APOD are trademarks of Masimo Corporation.

Page 11-12
 Chapter 12 RESP Monitoring

12.1 Generation of Resp

The Monitor measures the RESP based on the thoracic impedance between the two electrodes. The changes
of such impedance caused by thoracic movements will generate a RESP wave on the screen. The RR is
calculated from such wave.

12.2 Placement of Electrodes

In Resp measurement, it is important to prepare the skin properly for electrode placement. Refer to the
relevant section on ECG measurement.
The Resp signals are measured through the two ECG electrodes. In case of standard placement of ECG
electrodes, the Resp can be measured through the electrode RA and electrode LL.

12.2.1 Optimization of Lead Position

To measure the ECG and Resp simultaneously, it may be necessary to adjust the positions of the two
electrodes for some patients. Non-standard placement of ECG electrodes may cause changes to the ECG
waveform and affect the ST segment analysis and ARR analysis.
(1) Cardiac Superposition
The cardiac activities affecting the Resp waveform are defined as cardiac superposition, which occurs when
the electrodes acquire the impedance changes caused by rhythmic blood flow. Proper placement of
electrodes can reduce cardiac superposition and protect the liver area and ventricles against the cable
between the electrodes, which is especially important to neonates.
(2) Lateral thoracic dilatation
The Pediatric’s thorax will expand to both sides. At this point, it is best to place the two respiratory
electrodes in the right midaxillary and left lateral chest wherePediatric respiratory movement is the
strongest, so as to optimize the respiratory waveform. As shown in the figure below:

(3) Abdominal respiration

Some patients have limited chest movement and they breathe mainly through the abdomen.At this point,
you may want to place the left-leg electrode on the left abdomen with the strongest expansion to optimize
the respiratory waveform. As shown in the figure below:

Page 12-1
 Note
l RESP monitoringis not suitable for the Pediatrics with a large range of activities, otherwise it
may result in false alarms.

12.2.2 Placing Electrodes for RESP Measurement

The three-lead connection method shall be adopted, as shown in the figure below:

R (right arm) position: right under the

Right arm Left arm collarbone, near the right shoulder.
L (left arm) position: right under the
collarbone, near the left shoulder.
F (left leg) position: on the left lower
abdomen

Left leg

Figure 12-1 Three-lead electrode placement

Note
l Place the right-arm and left-leg electrodes diagonally for optimalrespiratory waveform. Liver and
ventricles shall be avoided to be located on the cable of the respiratory electrode, so as to avoid
the artifacts caused by heart covering or pulsatile blood flow.
l Check the attachment site every 2 to 3 hours to ensure proper skin texture and correct optical
alignment. If skin quality changes, move the sensor to another site. Change the electrode
wearing position at least every 4h.

12.3 RESP Setup

12.3.1 Resp Lead

Resp leads indicate the source of the current Resp waveform. You can set “Resp Lead” to RA-LA (I), RA-LL
(II) or “Auto”. If you select “Auto”, the Monitor will auto select an appropriate Resp lead.
1) Select the Resp parameter area or click the “physiological setup” to enter “Resp Setup” → “Resp Lead”.

Page 12-2
2) Select RA-LA (I), RA-LL (II) or “Auto”.

12.3.2 Resp Filter

This parameter is designed to filter out the Resp interference. Its default is “On”.
1) Select the Respwave area to enter “RespWave”.

2) Select “Resp Filter” to switch between “On” and “Off”.

Note
l In Resp measurement, the Monitor cannot recognize any obstructive or mixed no-breath but

trigger an alarm when the interval between two adjacent RESPs exceeds the set time.

12.3.3 Setup the Gain

(1) Gain is used for regulating the amplitude of the respiratory wave. The available gains include ×0.25, ×0.5,
×1, ×2 and × 4.
Click the “RESP Waveform Area”. In the pop-up menu “RESP Waveform”, select“Gain”→“×0.25”,
“×0.5”, “×1” , “×2” or“×4”.
(2) After setup, press the “ ” key to exit.

12.3.4 APNEA ALM Delay

No-breath detection is to detect the longest interval between two adjacent RESPs. When the actual no-
breath time of the patient exceeds the set no-breath time, the device will respond to no-breath alarms
according to the value of “APNEA ALM Delay”.
Set “No Breath Timeout”:
1) Select the Resp parameter area to enter “Resp Setup” →“No Breath Timeout” and set an appropriate

detection time.
Set “APNEA ALM Delay”:
1) Enter “Maintain”.

u Set “APNEA ALM Delay” to “Off”, “10s”, “15s”, “20s”, “25s”, “30s”, “35s” or “40s”.

If you select “Off”, the alarm delay function will be disabled.

12.4 Maintenance and Cleaning

Warning

Page 12-3
l Turn off the power and disconnect the AC power supply before cleaning the Infant Radiant
Warmer or sensor.
l If ECG cable is damaged or aged, replace it with a new one.

Page 12-4
1) Cleaning
The Infant Radiant Warmer and its sensor surface can be wiped with medical alcohol, air-dried or wiped
witha piece of clean and dry cloth.
2) Disinfection
To avoid long-term damage to the equipment, we recommend that the product be sterilized only if it
is deemed necessary in your Infant Radiant Warmer’s maintenance plan. It is also recommended to disinfect
the Infant Radiant Warmer first.
Recommended disinfectants for Infant Radiant Warmer:
- Ethanol group: 70% alcohol, 70% isopropyl.

12.5 Apnea Detection

The apnea detection is carried out only based on the physiological parameters. Choose System
Setup>Device Setup> Apnea setup, and set it to On or Off. When self-test swith is set to On, you can set the

associated apnea detection parameters. When apnea monitoring is enabled, the icon is displayed in
the menu bar of
the control panel. The icon disappears when the function is disabled.

12.6 Connecting the Apnea Wakeup Device

Place the apnea wakeup device in the center of the soles of the Pediatric and wrap the sensor and the foot
together with band. The band must be wrapped not too loose or too tight, in case the wakeup device drops
off or does not function properly, or the blood circulation is affected, resulting in change of the foot color.
See thefollowing figure:

Figure 12-2 connecting the apnea wakeup device

Warning
l Do not disinfect the wakeup device or immerse the wakeup device in liquid.
l Do not pull the cable of the wakeup device.
l Do not operate the wakeup device beyond the specified working temperature or environment.
l Do not use the wakeup device on a foot with trauma.

Page 12-5
12.7 Apnea Setup

When in physiological monitoring mode and respiration pause switch is on, click directly on the icon

in the menu above. See the following figure:

Figure 12-3 Apnea setup

n Self-test: The system checks whether the apnea wakeup device works properly. When it is set to
on, the device keeps vibrating, indicating that the device works properly. When it is set to Off, the
self-test function is disabled.
n RESP/CO2 setup: The value can be set to On and Off.
n SpO2 Setup: The value can be set to 80-90 in the unit of %. The default value is 85.
n HR Setup: The value can be set to 90-110 in the unit of bpm. The default value is 100.
If either of the RESP/CO2 setup values is set to On, wakeup vibration is triggered when the respiration
stops; wakeup vibration is not triggered when the respiration is normal. If both values are set to Off,
wakeup vibration is triggered when either the SPO2 value or HR value meets the triggering condition.
The triggering conditions are the values of SpO2 Setup and HR Setup.
n Default Setup: The Default Setup dialog box appears when this option is selected. When No is
tapped, the current operation is aborted and the original configuration remains unchanged. When Yes
is tapped, the default configuration is used to replace the original configuration.

12.8 Precautions and Procedure

During physiological monitoring, pay attention to the following items:
(1) Insert the cable plug of the wakeup device into the WAKE interface on the right side of the incubator.
(2) Wind the bandage of the wakeup device around the center of the soles of the Pediatric.
(3) Install the ECG lead cable.
(4) Choose Incubator Setup>Apnea Detection Setupin the menu bar and set apnea wakeup conditions.

Page 12-6
(5) When an Pediatric's respiration frequency is lower than 7 bpm and the situation lasts for a period
longer than the preset apnea alarm time, the wakeup device starts to vibrate to wake up the Pediatric.
After the Pediatric's respiration frequency is higher than 7 bpm, the wakeup device stops working.

Page 12-7
 Chapter 13 CO2 Monitoring

13.1 Overview
The device uses the CO2 measurement to monitor the patient’s breath state and control his/her ventilation.
There are two methods of measuring the CO2 in the patient’s airway:
u Sidestream measurement method: take samples from the respiratory gas sensor in the patient’s
airway at a constant flow rate and use the built-in remote CO2 sensor in the measurement system to
analyze them.
u Mainstream measurement method: install the CO2 sensor onto the airway connector inserted directly
into the respiratory system of the patient.
In the above two cases, the measurement principle is IR emission. Use the optical detector to measure the
intensity of the infrared rays penetrating the respiratory system. Such intensity depends on the CO2
concentration as some infrared rays will be absorbed by CO2molecules.
The CO2 measurement involves the following parameters (see the figure below):
² CO2 waveform ①
² End-tidal CO2 (EtCO2): the maximum partial pressure of CO2 at the end of a breath②
² EtCO2 alarm limit ③
² Fraction of inspiratory CO2 (FiCO2): the minimum CO2 value during inspiration ④)and its alarm limit
④
² Airway respiration rate (AWRR): the respirations per minute calculated from the CO2 waveform ⑤)
andits alarm limit⑤
² Measurement unit ⑥

Note

l Do not use the device in an environment with any flammable anesthetic gas.
l Only the trained professionals familiar with this Manual are allowed to operate the device.
l When the air pressure is too high, it may be affected by air tightness, and the monitoring result
may exceed the specified error range.
l Fluctuations with the specified voltage range have no effect, and the monitoring results may exceed
the specified error range when exceeding the range.

Page 13-1
Figure 13-1 CO2 Waveform and Parameter Display

Page 13-2
13.2 CO2 Module

CO2 module interface

Figure 13-2 Interface connected to a five-parameter CO2 module

13.3 CO2 Sensor Connection

13.3.1.1 Preparations for Mainstream CO2 Sensor Connection

1) Insert the mainstream CO2 module into the module slot.

2) Connect the mainstream sensor to the CO2 interface of the device.

3) Wait for 10s (Masimo sensor) or 2min (Respironics sensor) until the sensor reaches its working

temperature and a stable thermal state.

4) Connect the relevant airway adapter to the sensor head and make sure they engage with each

other inplace.

5) Zero the sensor.

6) Expose the sensor to the room air and keep it away from all CO2 sources, like respirator,

patientrespirations and user respirations.

7) Select the CO2 parameter area to enter “CO2 Setup” → “Zero”.

8) Install the airway adapter onto the proximal end of the respiration circuit, exactly speaking, between

theelbow and the Y-shaped tube of the respirator as shown in the figure below.

Page 13-3
 Install the airway
adapter here

Insert it in the respiration circuit

Airway Adapter

Figure 13-3 Mainstream CO2 Connection

13.3.1.2 Preparations for Sidestream CO2 Sensor Connection

1) Insert the sidestream CO2 module into the module slot.

2) Connect the sensor cable to the CO2 interface of the device.

3) Wait for 10s (Masimo sensor) or 2min (Respironics sensor) until the sensor reaches its working

temperature and a stable thermal state.

4) Connect the cannula, airway adapter or sampling tube (as the case may be) to the sensor reliably

untilyou hear a click sound.

To the device

Figure 13-4 Respironics Sidestream CO2 Connection Diagram

Page 13-4
5) Use the airway adapter for the patient with tracheal cannula: install the airway adapter onto the
proximal end of the respiration circuit, exactly speaking, between the elbow and the Y-shaped tube of
the respirator.

Figure 13-6 Connection of Airway Adapter

6) Wear the nasal cannula for the patient without tracheal cannula: wear the nasal or oral-nasal O2 cannula
onto the patient’s face, connect the O2 supply tube to the O2 supply system and set the O2 flow
asdirected.

Warning
l Check the airway adapter before use. Replace it if the airway adapter suffers from any exterior
damage or breakage.
l Turn it off when the CO2 sensor is idle or it will remain in working state and its service life will
be shortened.

13.4 Measurement Steps for Respironics Mainstream and

Sidestream Analyzer

The Respironics sidestream analyzer and Respironics mainstream analyzer have almost the same
measurement steps. Please follow the measurement steps for Respironics sidestream analyzer to operate
the Respironics mainstream analyzer.
1) Connect the CO2 sensor based on the CO2 sensor type rightly.

2) Select “Screen Layout” to call up the CO2 waveform and parameter to be monitored (skip this steps if

theCO2 waveform and parameter are already displayed on the screen).

3) Set “O2 Compensate” in “CO2 Setup” to “21” (in order to activate the value of “O2 Compensate”, never

skip this step even if “21” is already selected).

4) Set “Balance Gas” in “CO2 Setup” to “Room Air”, “N2O” or “Helium” (select “Room Air” if there is no N2O

or helium in the room).

5) Set “Altitude” in “CO2 Setup” to 0~5120.6m (default: 0m), depending on the local altitude. When the

Page 13-5
CO2 value is too high or too low, follow Table 13-1 to select the relevant barometric pressure based on

the local altitude (the barometric pressure changes with the altitude).

Page 13-6
 Barometric Pressure Conversion Table – EtCO2 Data Based on Altitude

Altitude Barometric 5% CO2

Pressure

Feet Meters mmHg EtCO2mmhg

Sea Level (0) Sea Level (0) 760 38

500 152.4 745 37

750 228.6 738 37

1,000 304.8 731 37

1,500 457.2 717 36

2,000 609.6 704 35

2,500 762 690 35

3,000 914.9 677 34

3,500 1066.8 665 33

4,000 1219.2 652 33

4,500 1371.6 640 32

5,000 1524 628 31

5,500 1676.4 616 31

6,000 1828.8 604 30

6,500 1981.2 593 30

7,000 2133.6 581 29

7,500 2286 570 29

8,000 2438.4 560 28

8,500 2590.8 549 27

9,000 2743.2 539 27

10,000 3048 518 26

10,500 3200.4 509 25

11,000 3352.8 499 25

11,500 3505.2 490 24

12,000 3657.6 480 24

Page 13-7
 12,500 3810 471 24

13,000 3962.4 462 23

13,500 4114.8 454 23

14,000 4267.2 445 22

14,500 4419.6 437 22

15,000 4572 428 21

15,500 4724.4 420 21

16,000 4876.8 412 21

16,500 5029.2 405 20

16,800 5120.6 400 20

Table 13-1
Note: it is assumed that the barometric pressure and temperature at the sea level are respectively
760mmHgand 0℃ (the altitude-based ambient temperature is 0℃).

Warning
l The device has no auto barometric compensation function. Please set the correct altitude before

using the CO2 measurement function for the first time. Incorrect altitude will cause incorrect

CO2 reading (5% CO2 error per 1,000m altitude difference).

6) Select “Zero” in “CO2 Setup”, and the prompt message “Zeroing, please wait 30s” will appear at the
lower right corner of the interface. Do not start the CO2 measurement until such prompt message
disappears.

13.5 Measurement Steps for Masimo Mainstream and Sidestream

Analyzer

The Masimo sidestream analyzer and Masimo mainstream analyzer have almost the same measurement
steps. Please follow the measurement steps for Masimo sidestream analyzer to operate the Masimo
mainstream analyzer.

13.5.1 Measurement Steps

Follow the steps below to set the device for gas analysis purpose:
1) Connect the CO2 sensor based on the CO2 sensor type rightly.

2) Connect the Nomoline sampling tube to the input interface of the ISA analyzer (CO2 sensor).
3) Connect the interface cable of the ISA analyzer to the CO2 interface of the device.

Page 13-8
4) Enter “Maintain” and activate the CO2 sensor.

5) Enter the general interface of the device and select “Screen Layout” to call up the CO2 waveform and

parameter to be monitored (skip this steps if the CO2 waveform and parameter are already displayed on

the screen).

6) Set an appropriate value for “O2 Compensate” and “N2O Compensate”.

7) Connect the gas sample outlet to the exhaust system or make the gas flow back to the patient circuit.

8) The green LED indicates that the ISA analyzer is ready for use.

9) Perform the checks before use.

10) Start the CO2 monitoring in case of normal check results.

13.5.2 Checks before Use

Perform the following operations before connecting the Nomoline sampling tube to the respiration circuit:
1) Connect the sampling tube to the gas inlet of the ISA CO2 sensor.

2) Check if the LED remains green stably (an indication of normal system).

3) Expire into the sampling tube and check if the device displays the effective CO2 waveform and value.

4) Block the sampling tube with a fingertip and wait 10s.

5) Check if the prompt message “Sampling line clogged” appears and the LED flashes in red.

6) Check the tightness of the patient circuit connected to the sampling tube when appropriate.

Note
l In order to prevent the condensed water dropping into the gas sampling tube and blocking it,

the gas sampling tube connection end of the airway adapter should point up.

Warning
l Hang the external CO2 analyzer onto the CO2 sensor holder reliably against falling anddamage.

l Place the IRMA sensor, if not protected by HME, with the status LED pointing up.

l Do not stretch the cable of the ISA sidestream gas analyzer.

l Operate the ISA sidestream gas analyzer in the specified working temperature environment

only.

l Make sure all connections are firm and reliable. Any leakage will cause the respiratory gas of

the patient to include the ambient air, resulting in incorrect readings.

Page 13-9
13.6 CO2 Setup

13.6.1 Work Mode

Follow the steps below to set its work mode after connecting the CO2 sensor to the device. Turn off the CO2
sensor for service life protection purpose once the CO2 measurement is stopped.
1) Select the CO2 parameter area to enter “CO2 Setup” → “CO2 swith”.

2) Select “ON” or “OFF”.

13.6.2 Pressure Unit

Select the CO2 parameter area or CO2 waveform area to set “Pressure Unit”.

13.6.3 Gas Compensation

1) Select the CO2 parameter area to enter “CO2 Setup”.

u Masimo CO2 sensor:

² Select “O2 Compensate” → “High”, “Med” or “Low”.

² Select “N2O Compensate” → “On” or “Off”.

u Respironics CO2 sensor:

² Select “O2 Compensate” → set the O2 compensation value.

Warning
l Please set “O2 Compensate” and “N2O Compensate” based on the actual conditions, or the

measurement results may differ greatly from the actual values to cause misdiagnosis.

13.6.4 Apnea Alarm Delay

No-breath detection is to detect the longest interval between two adjacent RESPs. When the actual no-
breath time of the patient exceeds the set no-breath time, the device will respond to no-breath alarms
according to thevalue of “APNEA Alm Delay”.
Set “No Breath Timeout”:
1) Select the CO2 parameter area to enter “CO2 Setup” → “No Breath Timeout” and set an

appropriatedetection time.

Set “APNEA Alm Delay”:

1) Enter “User Maintain” → “Other Setup”.

2) Set “APNEA Alm Delay” to “Off”, “10s”, “15s”, “20s”, “25s”, “30s”, “35s” or “40s”.
If you select “Off”, the alarm delay function will be disabled. The device will respond to no-breath alarms (if
any) immediately.

Page 13-10
13.6.5 Altitude

For Masimo CO2 sensor, there is no need to set the altitude.

For Respironics CO2 sensor:
1) Select the CO2 parameter area to enter “CO2 Setup” → “Altitude Unit”.

2) Select the CO2 parameter area to enter “CO2 Setup” → “Altitude”.

3) Set an altitude value and the device will auto set “Baro. Pressure” (Barometric Pressure) based on

thealtitude value.

13.6.6 Balance Gas

Only the Respironics CO2 sensor requires you to set the balance gas manually (for Masimo CO2 sensor, the
balance gas is auto set).
1) Select the CO2 parameter area to enter “CO2 Setup” → “Balance Gas”.

2) Select “Room Air”, “N2O” or “Helium”.

13.6.7 Waveform Scale

If you adjust the scale value, the waveform amplitude will change accordingly.
Select the CO2 waveform area to enter “Waveform Setup” → “Scale”.

13.7 Maintenance and Cleaning of Respironics Mainstream and

Sidestream CO2 Sensor

13.7.1 General Cleaning

Dip a cloth in 70% isopropyl alcohol, water solution (bleach) containing 10% sodium hypochlorite,
disinfecting spray cleaner (like Steris Coverage SprayHB), ammonia water or mild soapy water, wash it with
water, wring it and then use it to clean the sensor. Dry it and make sure its sight glass is clean before using
thecleaned sensor.

13.7.2 Clean the Reusable Airway Adapter of Mainstream Sensor

Wash the airway adapter with mild soapy water, dip it in the disinfectant, like 70% isopropyl alcohol, water
solution (bleach) containing 10% sodium hypochlorite, 2.4% glutaraldehyde solvent (Cidex Plus, Steris System
1, etc.) or ammonia water, and then rinse it with sterile water and dry it.

13.7.3 Disinfection of Reusable Airway Adapter

Autoclave: applicable to the airway adapter for adults only. ETO:

disinfect the airway adapter for 1.5h.

Page 13-11
Dip in Perasafe solvent for 10h.
U.S. Steris System 1 low-temperature sterilization cabinet.
Make sure it is not damaged in operations or in the cleaning/disinfection process and its sight glass is dry
without any residue before using the disinfected airway adapter.

13.7.4 Disinfection Frequency of Reusable Airway Adapter

The above disinfection methods allow you to reuse the airway adapter for 100 times.

13.7.5 Zeroing

Usually, the CO2 sensor will be auto zeroed when necessary. You can zero it manually when you consider it
necessary: select “CO2” in the parameter area to enter “CO2 Setup” and then select “Zero” to zero the CO2
sensor. Keep the patient circuit in the ambient air (21% O2 and 0% CO2) for 30s in the zeroing process. The
CO2 sensor is zeroed successfully when the prompt message “Zeroing, please wait 30s” disappears.

13.8 Masimo Mainstream and Sidestream Module Related

Information

13.8.1 Zeroing

In order to eliminate the effect of the baseline drift on measurement results and obtain accurate
measurement results, please zero it before using the CO2 sensor to device the patient.
Usually, the CO2 sensor will be auto zeroed when necessary. You can zero it manually when you consider it
necessary: select “CO2” in the parameter area to enter “CO2 Setup” and then select “Zero” to zero the CO2
sensor. Keep the patient circuit in the ambient air (21% O2 and 0% CO2) in the zeroing process. The CO2
sensor is zeroed successfully when the prompt message “CO2 is zeroing” disappears.
13.8.1.1 Zeroing ISA CO2 Module
The ISA CO2 Module needs to establish a zero reference level for the CO2 measurement. This zero calibration
is here referred to as “Zeroing”.
The ISA sidestream gas Module performs zeroing automatically by switching the gas sampling from the
respiratory circuit to the ambient air. The automatic zeroing is performed every 24 hours and takes less than
3 seconds for ISA CO2 gas module. During zeroing, if ISA’s exhaust gas is return to the patient circuit, the
return gas level will be different from the gas level at the sampling site.

Warning
l Since successful zeroing requires the presence of ambient air in the gas module, ensure that
the ISA is placed in a well ventilated place. Avoid breathing near the ISA sidestream gas
module before or during the zeroing procedure.

Page 13-12
13.8.1.2 Zeroing IRMA CO2 Module
In order to secure high precision of the IRMA probe measurements the following zeroing recommendations
should be followed.
Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe, without connecting the
airway adapter to the patient circuit, and then using the medical backboard device to transmit a Zero
reference command to the IRMA probe.
Special care should be taken to avoid breathing near the airway adapter before or during the Zeroing
procedure. The presence of ambient air in the IRMA airway adapter is of crucial importance for a successful
Zeroing. If a “CO2 Need Zero” alarm should appear directly after a Zeroing procedure, the procedure has to
berepeated.
Always perform a pre-use check after zeroing the probe.

IRMA CO2 probes:

Zeroing needs to be performed ONLY when an offset in gas values is observed, or when an unspecified
accuracy message is displayed.
Allow 10 seconds for warm up of the IRMA CO2 probes after power on before proceeding with the Zeroing
Procedure.
Allow the IRMA probe to warm up for at least 10 seconds after changing the IRMA airway adapter before
transmitting the Zero reference command.

Warning
l Incorrect probe Zeroing will result in false gas readings.

13.8.1.3 Maintenance
Verify the gas readings regularly. Contact the engineers from the manufacturer for maintenance in case of any
inaccurate reading.
13.8.1.4 CO2 Sensor LED
LED indications:
Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady red light Sensor error
Blinking red light Check adapter

13.8.2 Adverse Effects on Performance

1) The following factors have the known adverse effects on the specified performance:
l Quantitative effects of RH or condensation;
l Leakage of sampling gas and internal exhaust;

Page 13-13
 l Quantitative effects of atmospheric pressure;
l The sample gas is returned to the respiratory system;
l Quantitative effects caused by Voltage fluction of power supply system or battery;
l Interfering gas or water vapor; and
l Other interference sources.
2) Gas Measurement Unit
Use volume percentage as the gas concentration unit. Below is the concentration calculation formula:

Use the cup-making pressure sensor of the ISA gas analyzer to measure the total pressure of the gas mixture.
To convert into any other unit, you can use the actual barometric pressure sent from the ISA
sidestream(IRMA mainstream).
CO2 (mmHg) = (CO2 Concentration) x (Barometric Pressure from ISA (kPa)) x (750 / 100).
Take 5.0 vol% CO2 @ 101.3kPa as an example: 0.05 x 101.3 x 750 / 100 = 38 (mmHg).

3) Effects of RH
The partial pressure and volume percentage of the CO2, N2O, O2 and anesthetic gas depend on the water
vapor content in the measured gas. Calibrate the O2 measurement, and the displayed value at the ambient
temperature and RH level will be 20.8 vol%, not the actual partial pressure. The 20.8 vol% O2 represents the
actual O2 concentration of the room air (water concentration: 0.7 vol %) (For example, 25°C and 23% RH @
1013 hPa). The device will keep displaying the actual partial pressure at the current RH level when measuring
the CO2, N2O and anesthetic gas (like all gases measured by infrared cell).
In the patient’s alveoli, the water vapor in the respiratory gas is saturated (BTPS) at the body temperature.
Before the acquired respiratory gas in the sampling tube is transferred to the ISA sidestream gas analyzer,
itstemperature becomes approximate to the ambient temperature. No water will enter the ISA gas analyzer
afterthe Nomoline sampling tube removes all condensed water. The RH of the acquired gas is approximately
95%. Use the following formula to calculate the CO2 value at BTPS:

In the above formula:

EtCO2: EtCO2 value “vol%” sent from ISA Pamb:
barometric pressure “kPa” sent from ISA
3.8 : typical partial pressure “kPa”of the water vapor condensed between the patient circuit and
ISAEtCO2 (BTPS) = EtCO2 concentration “vol%” at BTPS
It is assumed that the O2 is calibrated by the room air at 0.7 vol% H2O (RH).

Page 13-14
13.8.3 Safety Alarm Information

13.8.3.1 ISA Sidestream Gas Analyzer Safety Warning Information

Warning

l The ISA sidestream gas analyzer is intended for use by authorized healthcare professionalsonly.
l Carefully route the sampling line to reduce the risk of patient entanglement or strangulation.
l Do not lift the ISA gas analyzer by the sampling line as it could disconnect from the ISA,
causing the ISA gas analyzer to fall on the patient.
l Dispose Nomoline Family sampling lines in accordance with local regulations for biohazardous
waste.
l Use only airway T-adapters with the sampling point in the center of the adapter.
l Do only use sample lines intended for anesthetic agents if N2O and/or anesthetic agents are
being used.
l Do not use T-adapter with infants, as this adds 7 ml dead space to the patient circuit.
l Do not use the ISA gas analyzer with metered-dose inhalers or nebulized medications as this may
clog the bacteria filter.
l Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2), ensure that
the ISA is placed in a well ventilated place. Avoid breathing near the ISA sidestream gas analyzer
before or during the zeroing procedure.
l Never sterilize or immerse the ISA sidestream gas analyzer in liquid.
l The ISA sidestream gas analyzer is intended only as an adjunct in patient assessment. It must be
used in conjunction with other assessments of clinical signs and symptoms.
l Measurements can be affected by mobile and portable RF communications equipment. Make sure
that the ISA sidestream gas analyzer is used in the electromagnetic environment specified in this
manual.
l Replace the sampling line if the sampling line input connector starts flashing red, or the medical
backboard device displays a “Check sampling line” message.
l No modification of this equipment is allowed without authorization of the manufacturer. If this
equipment is modified, appropriate inspection and testing must be conducted to ensure
continued safe operation.
l The ISA sidestream gas analyzers are not designed for MRI environments.
l During MRI scanning, ISA must be placed outside the MRI suite.
l Use of high frequency electrosurgical equipment in the vicinity of the ISA/medical backboard
device may produce interference and cause incorrect measurements.

Caution

l The ISA analyzers should be securely mounted in order to avoid the risk of damage to the
ISA.
l Do not operate the ISA sidestream gas analyzer outside the specified operating environment.
l (US Only) Caution: Federal law restricts this device to sale by or on the order of a physician.
l For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, precautions and adverse events.

Page 13-15
13.8.3.2 IRMA Mainstream Gas Analyzer Safety Warning Information

Warning

l The IRMA analyzers should be securely mounted in order to avoid the risk of damage to the IRMA.
l Do not operate the IRMA sidestream gas analyzer outside the specified operating environment.
l (US Only) Caution: Federal law restricts this device to sale by or on the order of a physician.
l For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, precautions and adverse events.
l The IRMA probe is intended for use by qualified medical personnel only.
l The IRMA probe is intended only as an adjunct in patient assessment. It must be used in
conjunction with other assessments of clinical signs and symptoms.
l Disposable IRMA airway adapters shall not be reused. Reuse of the single use adapter can cause
cross infection.
l Used airway adapters shall be disposed of in accordance with local regulations for biohazardous
waste.
l Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 ml dead
space to the patient circuit.
l Do not use the IRMA Infant airway adapter with adults as this may cause excessive flow
resistance.
l Measurements can be affected by mobile and RF communications equipment. It should be
assured that the IRMA probe is used in the electromagnetic environment specified in this manual.
l Use of high frequency electrosurgical equipment in the vicinity of IRMA may produce interference
and cause incorrect measurements.
l The IRMA probe is not designed for MRI-environments.
l Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this
may allow patient secretions to block the adapter windows and result in incorrect operation.
l To keep secretions and moisture from pooling on the windows, always position the IRMA probein
a vertical position with the LED pointing upwards.
l Do not use the IRMA airway adapter with metered dose inhalers or nebulized medications as
this may affect the light transmission of the airway adapter windows.
l Incorrect probe zeroing will result in false gas readings.
l Replace the airway adapter if rainout/condensation occurs inside the airway adapter.
l Use only Masimo manufactured IRMA airway adapters.
l The IRMA probe is not intended to be in patient contact.
l If, for whatever the reason, the IRMA probe is in direct contact with any parts of the infant's
body an insulation material shall be placed between the IRMA probe and the body.
l No modification of this equipment is allowed.

Caution

l Never sterilize or immerse the IRMA probe in liquid.

l The IRMA airway adapters are non-sterile devices. Do not autoclave the devices as this will
damage them.
l Do not apply tension to the probe cable.

Page 13-16
 l Do not operate the IRMA probe outside the specified operating temperature environment.
l (U.S. only) Caution: Federal law restricts this device to sale by or on the order of a physician.
l For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, precautions and adverse events.

13.8.4 Airway Obstruction

When the anesthetic gas airway is obstructed, on the screen there will be such a prompt message as “Sampling
Line Clogged”; under such a circumstance, replace the Nomoline sampling line.

Warning

l Do not use the ISA gas analyzer together with a quantitative spraying agent or pulverization
treatment; otherwise it may result in the clogging of the germ filter.

13.8.5 Discharging Waste Gases

When nitrous oxide and/or an anesthetic gas are used, you should prevent these gases from polluting the
operating room. Usually the gas discharging outlet should be connected to (via the gas discharging pipe
connected to the sample gas outlet of the host equipment):
A discharging system (used for discharging collected gases) or the patient circuit (used for the back flowing
ofcollected gases)

Warning

l Anesthetics: When an anesthetic which is being used or a patient who recently used an
anesthetic is measured, the gas discharging hole on the module must be connected to a waste
gas processing system or the patient circuit (on the anesthesia machine or the respirator), so as
to prevent medical personnel from inhaling the anesthetic.

13.8.6 Leakage Check

1. Connect a new Nomoline sampling line with male Luer lock to the ISA gas inlet connector and check
that the gas inlet connector shows a steady green light.
2. Connect short silicon tubing with an inner diameter of 3/32” (2.4 mm) to the Nomoline male Luer.
3. Exhale a long breath into the silicon tubing until the CO2 concentration is greater than 4.5 vol% or
34mmHg.
4. Quickly connect the silicon tubing tightly to the exhaust port.
5. Wait 1 minute until the CO2 concentration has stabilized. Note the value.
6. Wait 1 minute and check that the CO2 concentration has not decreased more than 0.4 vol% or 3 mmHg.
If it has decreased more there is a major leakage in the ISA unit or in the Nomoline. Do not operate the
ISAif there is a major leakage in the unit.

Page 13-17
13.8.7 Safety Symbols

Text, Color Code and Text

Symbol Description
Format
“Warning” indicates the hazardous conditions causing
Warning: additional
possible personal injuries or death. The warning
information.
symbol should comply with ISO 7010-W001.

User’s Manual Refer to the User’s Manual.

Reference No. /

Serial No. /

Lot No. /

Valid until [YYYY-MM-DD] Do not use the device after such date.

Temperature limit /

Pressure limit /

RH limit /

No reuse /

Recycle this electrical and electronic equipment

WEEE directive
according to 2002/96/EC.

Contain Pb /

The IP grade indicates the water ingress protection

IP grade
performance.
IP grade against water and Protection against tools and short cable ends (>1mm).
solid object ingress Protection against water sprays from all directions.
Warning (U.S.): the device shall be sold by medical
Sold on prescription only practitioners or on prescription according to U.S.
federal laws.

CO2 The IRMA/ISA analyzer measures CO2 only.

Page 13-18
 Multiple gases (AX+ or
The IRMA/ISA analyzer can measure multiple gases.
OR+)

Gas inlet /

Gas (exhaust) outlet /

Illustrate the connection between Nomoline and

Connect to patient circuit
patient circuit.

Connect to ISA Illustrate the connection between Nomoline and ISA.

Not sterile, latex free The device is latex free and not sterile.

13.8.8 Patents and Trademarks

(1) Patent Statement

Masimo Sweden AB owns the following patents for relevant products described in this operating
instruction manual: SE519766; SE519779; SE523461; SE524086. Other patents are being applied.
(2) Trademark
Masimo IRMA™, Masimo ISA™, Masimo XTP™, Sigma Multigas Technology™, LEGI™, Nomoline™, IRMA
EZ Integrator™, Masimo GasMaster™ and ISA MaintenanceMaster™ are trademarks of Masimo
Sweden AB.

13.8.9 Consumables

13.8.9.1 ISA Nomoline Family

ISA samples gas from the respiratory circuit through the Nomoline Family sampling line at a rate of 50
sml/min, making measurements of CO2 possible for adult, pediatric and infant patients.
The Nomoline Family sampling lines incorporate a unique water separation (NO MOisture) section, which
removes condensed water. The NOMO section is also fitted with a bacteria filter that protects the gas
analyzerfrom water intrusion and cross contamination.
As long as no sampling line is connected, the ISA gas analyzer remains in a low-power sleep mode. Once the
sampling line is connected, the ISA gas analyzer switches to measuring mode and starts delivering gas data.
The Nomoline Family sampling lines are available in a wide variety of versions for both intubated and
spontaneously breathing patients and in both disposable and re-sposable configurations –intubated
patients can for instance be monitored using the disposable Nomoline Airway adapter Set or a com-bination
of the multiple patient use Nomoline Adapter and a disposable Nomoline Extension / T-adapter.
Spontaneously breathing patients could similarly be monitored using a disposable Nomoline Nasal CO2
Cannula or a combination of the multiple patient use Nomoline Adapter and a disposable Nomoline Nasal
CO2 Cannula with Luer Connector.

Page 13-19
The Nomoline Adapter may be used with other third party sampling lines and cannulas. Please however note
that the Nomoline Family of sampling lines are designed for optimal performance and measure-ment fidelity
when used with the ISA gas analyzers. For instance, when connecting to a respiratory circuit, the Masimo T-
adapter provides a central gas sampling point thereby minimizing the the risk of sampling line occlusion.

Attention

l Using sample tubes or cannulas with larger inner diameter than 1 mm will increase ISA’s total

system response time.

Nomoline Family sampling line replacement

Nomoline Family sampling lines should be replaced according to good clinical practice or when the sampling
line gets occluded. Occlusion occurs when water, secretion etc. is aspired from the respiratory circuit to such
extent that ISA cannot maintain the normal 50 sml/min sample flow. This situation is indicated by a red
flashing gas inlet connector and an alarm message “Sampling Line Clogged”; Replace the Nomoline and wait
until the gas inlet connector switches to green indicating that the ISA gas analyzer is ready for use.
13.8.9.2 IRMA Airway Adapter
The IRMA airway adapter is inserted between the endotracheal tube and the Y-piece of the breathing circuit.
The respiratory gas measurements are obtained through the XTP™ windows in the sides of the adapter. The
XTP windows are transparent to light in the wavelength ranges of interest and they are specially designed
using the latest advances in material technology to provide a window minimizing the impact of water
vaporon light transmission.

Warning

l Replace the airway adapter if rainout/condensation occurs inside the airway adapter.

The IRMA airway adapter is designed as a non-sterile single patient use disposable for both Adult/Pediatric
and Infant applications. The IRMA Infant airway adapter has specially designed connectors for minimizing
the dead space and can be used even for very small patients.

Warning

l Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 ml

dead space to the patient circuit.

l Do not use the IRMA Infant airway adapter with adults as this may cause excessive flow

resistance.

13.8.10 Maintenance

The user should verify gas readings regularly; If finding any problems, please contact an engineer of the

Page 13-20
manufacturer for maintenance.

13.8.11 Cleaning the Analyzer

The “Plug in and measure” ISA sidestream gas analyzer should be cleaned regularly. Use ethanol or isopropyl
alcohol with a maximum concentration of 70% and a wet rag to clean the analyzer..
In order to prevent the cleaning liquid and dust from entering into the ISA gas analyzer from the LEGI
interface, the Nomoline sampling line should be connected all the time during analyzer cleaning.
Before cleaning the IRMA probe, take off the disposable IRMA airway adapter.

Warning

l The Nomoline sampling line is not a germ free device. In order to prevent the sampling line from

causing damages, please never carry out high pressure disinfection on any part of the sampling

line.

l Never sterilize the ISA sidestream gas analyzer and the IRMA probe or soak them into a liquid.

Page 13-21
 Chapter 14 Information Review
Information review, including: trend graph review, trend chart review, NIBP measurement review, and alarm
event review.
The device provides 120-hour trend data for all parameters, 2000 sets of NIBP measurement data, and
storageof 300 parameter alarm events. This Chapter details how these stored data are observed.

14.1 Trend Graph Review

The trendgraph for the last hour can be displayed at a resolution of one data per second or every 5s; the
trend graph for the last 120 hours can be displayed at a resolution of one data per minute, every 5min, or
every 10min. Directly click the "Physiological Setupat the bottom menu bar, " → "Information Review",

select "Trend Graph Review". As shown in the figure below:

Figure 14-1Trend graph review

The y-coordinate indicates the measured value; the x-coordinate indicates the measurement time.
Select the trend graph of different parameters for display:
Select "Parameter Selection" to modify the display content. When the desired parameter appears, click this
parameter, then the trend graph of this parameter will appear in the window.
（a） Select the trend graph for 1h or 120h:
Select "Resolution". If you want to observe the trend of 1 hour, select 1s or 5s. If you want to observe the
trend of 120 hours, select 1min, 5min or 10min.
（b） Observe the trend curvesof earlier or later time:

In the trend graph review window, select "Shift Timeline", then click “ ” or “ ”. Press “ ” to observe

Page 14-1
the trend curve of earlier time; press “ ” to observe the trend curve of later time.
（c） Change the display ratio:

In the trend graph review window, select “ ” or “ ” to change the ratio of y-coordinate.The ratio of
trend curve changes accordingly. The values in the data that are larger than the maximum coordinate are
expressed in the maximum value.
（d） Get trend data at a time on the current trend graph:

In the trend graph review window, select“Move Cursor”, then press “ ” or “ ”. Thecursor will move
along with it, and the moment it refers to will also change.The value of the parameter at this moment will be
displayed on the x-coordinate. The value on the x-coordinate will be displayed on the right side of
thewindow.
（e） Operation example:
Observe the NIBP trend graph for the last hour:
(1) Directly click the "Physiological Setup" at the bottommenu bar → "Information Review", then select
"Trend Graph Review."
(2) In the "Trend Graph Review" window, select "Parameter Selection" → "NIBP".
(3) In the item “Solution”, select “1s” or “5s”.

(4) Click “ ” or “ ” to observe the changes in time of the trend graph, trend curve and values.

(5) Stop in the period of time requiring careful observation. If the ratio of y-coordinateis not suitable, for

example, if some trend values exceed the maximum value of the current y-coordinate, then click “ ”

or“ ” to adjust the ratio of y-coordinate.

(6) Press “ ” button to exit the trend graph observation.

14.2 Trend Chart Review

The trend chart for the last 120 hours can be displayed at a resolution of 1min, 5min, 10min, 30min and
60min. directly click the “Physiological Setup” → "Information Review"at the bottom menu bar, select "Trend
Chart Review". As shown in the figure below:

Page 14-2
 Figure 14-2 Trend chart review

(a) Trend chart review:

The time corresponding to each group of trend data is displayed on the bottom row. The time that a page can

display is determined by theresolution of time. The user can use “ ” and “ ” buttons in the Trend
Chart Review window to switch the time required for observation. The parameter names of each group are
displayed in the leftmost column. Each row is a trend of the same parameter at different time. The user
can toggle the

parameters to be observed through the “ ” and “ ” buttons in the Trend Chart Review window. The
parameters are arranged in the order of HR(BPM), RR(BPM), SPO2(%), PR(RPM), NS(mmHg), NM(mmHg),
ND(mmHg), CO2(Kpa), INS(Kpa) and AwRR(Kpa).
(b) Select the trend chart of different resolutions:
Select "Resolution" to enter the menu, then selects the trend data interval.
(c) Observe the trend data of different parameters:

Select “ ” and “ ” buttons toobserve other parameters that are not in the current view.

(d) Observe the trend curvesof earlier or later time:

Select “ ” and “ ”page-turning buttons to look down for more recent trend data, and to look upward for

further trend data.

(e) Operation example:
Observe the NIBP trend chart:
(1) Directly click the "Physiological Setup" → "Information Review"at the bottommenu bar, then select
"Trend Chart Review."
(2) In the "Trend Chart Review" window, select "Resolution", then select "1min".
(3) Select “ ” and “ ” to scroll up and down, untilNIBP trend data is displayed on the screen.

Page 14-3
(4) Click “ ” or “ ” page-turning buttons to observe farther or more recent trend data.
(5) Press “ ” button to exit the trend chart observation.

Page 14-4
14.3 NIBP Measurement Review
The device is able to display the latest 2000 sets of NIBP measurements in a NIBP measurement review.
Directly click the "Physiological Setup" → "Information Review"at the bottom menu bar, then select "NIBP
Measurement Review". The window will display recent 10 NIBP measurement results and measurement
time. As shown in the figure below:

Figure 14-3 NIBPmeasurement review

The data is arranged from far to near in chronological order. Each screen can display 10 sets of measurement
data. Select“ ” and “ ” to observemore later or earlier data. Up to 2000 sets of measurements can
be displayed. When the number of measurements exceeds 2000, the data of the latest 2000 sets will be
displayed,
and the old data will be overwritten by the new
data.In this window, you can review the PR data.

14.4 Alarm Event Review

Directly click the "Physiological Setup" → "Information Review"at the bottom menu bar, then select "Alarm
Event Review". As shown in the figure below:

Figure 14-4 Alarm event review setup

In this menu, the user can set alarm review conditions, including the followings:
Page 14-5
(a) Start time of alarm review
The user can set the start time of the review in the "Start Time" item, but this time will be limited by the
system if the data exceeds the time you set.
(b) Selection of alarm review event
In Review Events, the user can select the parameters to be viewed. The options include "All" (alarm events
forall parameters) or any one of the ECG, SPO2, NIBP, CO2, RESP, TEMP parameters.
(c) Alarm event review
Alarm event review menu shows the following information, as shown in the figure below:
= Alarm occurrence time (format: day-month-year hour:minute:second);
= Event type.

Figure 14-5 Alarm Event Review

14.5 Wave holographic review

The device can display ECG waveform holographic playback of no less than 24 minutes in the waveform
holographic review window under the condition of inserting the USB flash drive. As shown below:

Figure 14-6 Wave holographic review window

Page 14-6
 Figure 14-7 Figure of wave holographic review

Notes:

” ”: Each time click the key, the window displays the waveform corresponding to the time axis changing forword

for6 seconds.

” ”: Each time click the key, the window displays the waveform corresponding to the time axis changing backwark

for 6 seconds.

Page 14-7
 Chapter 15 Alarm Setup

15.1 Overview
Alarm refers to the instructions given by the Infant Radiant Warmer to the medical staff through sound and
light, in case of abnormal vital signs changes of the Pediatric in the Infant Radiant Warmer or in the case that
failure of the Infant Radiant Warmer leads to the inability of Pediatrics to use the Infant Radiant Warmer.

Note
l When the device is powered on, it will detect whether the functions of alarm sound and alarm light
is normal. Under normal circumstances, the device will send a "beep" sound alarm, and red and
yellow alarm indicators flash alternately. If the sound and function of the alarm indicator are
abnormal, do not use the device, and immediately contact with the Company. For other alarm
detection methods, refer to "15.7 Alarm System".
l When multiple alarms of different levels occur at the same time, the device will give the light and
sound alarms according to the alarm of the highest level in all the current alarms.
l The user shall set the volume and alarm limits according to the actual situation of the Pediatric.
You cannot rely on the audible alarm system for Pediatric monitoring. Adjusting the alarm sound to
a small volume may cause the Pediatric to be in danger. Users shall pay close attention to the
actual clinical status of the Pediatric.
l The parameters displayed on the display of the device and alarm information are for reference
only by clinicians, and cannot be directly used as the basis for clinical treatment.

15.1.1 Alarm Type

According to the alarm properties, the alarms of this Infant Radiant Warmer can be divided into parameter
alarm, technical alarm and prompt message.
(1) Parameter alarm
The parameter alarm is usually caused by the Pediatric's physiological parameters exceeding the setup
range of the upper or lower alarm limits or the Pediatric's physiological abnormalities. The alarm information
of the parameter alarm is displayed in the parameter alarm area at the top of the screen.
(2) Technical alarm
Technical alarm, also known as system error message, refers to an alarm triggered when some system
function is not functioning properly or the monitoring result is distorted due to improper operation or system
failure. The alarm information of the technical alarm is displayed in the technical alarm area at the top of the
screen.
(3) Prompt message

Page 15-1
Strictly speaking, the prompt message is not an alarm. It means that in addition to parameter alarms and
technical alarms, Infant Radiant Warmer also displays some information related to the status of the
system,

Page 15-2
which generally does not relate to the Pediatric's vital signs. The prompt messages are displayed in the system
prompt message area.

15.1.2 Alarm Level

According to the severity of the alarms, the parameter alarms of the Infant Radiant Warmer can be
dividedinto advanced alarm, intermediate alarm and low-level alarm.
(1) Advanced alarm
The Pediatric is in a critical condition and may be life-threatening and shall be rescued immediately.
(2) Intermediate alarm
Abnormal physiological signs of Pediatrics, which shall take appropriate measures or treatmentimmediately.
(3) Low-level alarm
Abnormal physiological signs of the Pediatric, which may need to take appropriate measures or treatment.
The level of all technical alarms and certain parameter alarms has been set at the time of delivery of the
InfantRadiant Warmer and cannot be changed by the user. The alarm level of some parameters can be
modified.

15.2 Type of Alarm

When an alarm occurs, the Infant Radiant Warmer prompts the user with the following audible and visual
alarms:
l Light alarm
l Audible alarm

l Alarm information

l Parameter blinks
Among which, the light alarm, audible alarm and alarm information respectively distinguish the alarm
levelsin different ways.

15.2.1 Light Alarm

When an alarm occurs, the alarm indicator prompts the alarms of different levels through different colors
andflashing frequencies.
l Advanced alarm: Red light flashes. (frequency 2Hz)
l Intermediate alarm: Yellow light flashes. (Frequency 0.5Hz)
l Low-level alarm: Yellow light is always on without flashing.

15.2.2 Audible Alarm

Audible alarm means that when an alarm occurs, the Infant Radiant Warmer uses different sound
characteristics to alert different levels of alarms.
l Advanced alarm: beep - beep - beep - beep - beep.

Page 15-3
l Intermediate alarm: beep - beep - beep.
l Low-level alarm: beep.

Page 15-4
15.2.3 Alarm Information

Alarm information means that when an alarm occurs, the Infant Radiant Warmer’s parameter alarm zone or
technical alarm zone will display the corresponding alarm information, using different colors to
distinguishthe alarm information level:
l Advanced alarm: red
l Intermediate alarm: yellow
l Low-level alarm: yellow
The following flags are used in front of the alarm information to distinguish the level of the alarm
information:
l Advanced Alarm: ***
l Intermediate alarm: **
l Low-level alarm: *

15.2.4 Alarm Parameter Flashing

When a parameter alarm occurs, the parameter flashes once per second.

15.2.5 Alarm Status Icon

In addition to the above alarm methods, the following alarm status icons appear on the screen to indicate
different states of the alarm.

: It indicates alarm silence.

15.2.6 Alarm Delay

Serial
Alarm delay item Delay time
number
Just turn on or change the set temperature delay for 10 minutes, other
1 Hyperthermia / too
low cases delay 15 seconds

2 RESP apnea
3 CO2 apnea Determined by the alarm delay in the “maintain” →”apnea alarm
4 SpO2 apnea delay”, which can be set to “off, 10'40 seconds”, default 15
5 HR apnea
seconds.

Lamp head horizontal / After the lamp head is horizontally/vertically removed, the delay is 1
6
vertical removal minute to trigger the alarm.

15.3 Alarm Setup

Click the "System Setup" at the bottom menu bar, then enter the "Alarm Setup". The setup window pops

Page 15-5
 Figure 15-1Alarm setup

Print alarm automatic: on, off. When “Off”, the waveform of the alarm record will not be printed; if
“ON”, if the alarm print function of a parameter module is turned on, when the parameter module has
an alarm, the printer will be idle, and the device will automatically print the alarm event. And waveform
parameters. The alarm print function is turned on or off in the "Alarm Print: On/Off" option in the setup
menu of the corresponding parameter area.
Alarm volume: There are six kinds of alarm volume, namely "1 ~ 6" levels. After selecting "1 ~ 6" levels,
the system will alarm with the selected alarm volume.

15.4 Audio Paused

Warning
l Do not block the alarm speaker located on the back of the control panel near the heat vent,
otherwise it will disturb the audible alarm.

15.4.1 Setup the Audio Paused

There are two ways to realize audio paused:

A. Press the audio paused button on the display to set the audio paused state, that is, the device's

alarm iscanceled, and the “ ” icon will be displayed at the top right of the screen.
B. The effective sensing range of the gesture audio paused sensor (optional) is less than 150mm.When

sensing someone waving, the alarm indicator icon “ ” will show up in the user interface. Meanwhile,
the countdown time will be displayed under the icon: The device defaults audio paused time 120s, it
can be adjusted through the device maintenance interface, and the longest do not exceed 15
minutes. The
audio paused is then actuated. After the audio paused is over, the icon is displayed as “ ”.

Page 15-6
15.4.2 Canceling the Audio Paused

In audio paused state, when the following conditions are satisfied, it would be release the current audio
paused state to restore the alarm. Meanwhile, the audio paused icon at the top right of the screen is

displayedas“ ”.
Ø press the audio paused button
Ø AC power failure alarm occurs
Ø audio paused countdown ends
Ø alarm clear

15.5 Detection Alarm System

Unplug the main AC power switch, and check whether to prompt the AC power-off alarm. Observe the Infant
Radiant Warmer's changes in sound, light and parameter flashing. For details, see "Audible Alarm and Alarm
Information" in this Chapter.

Note
l When multiple alarms occur at the same time, the advanced alarm will be prompted first.
l When AC power supply is off, the output power of the heating tube is 0W, and the phototherapy
lamp, puncture lamp, bassinet lifting and bassinet tilting function are no longer supported.
l When AC power supply is off and the battery power is on, the Infant Radiant Warmer will
maintain its current setup.
l When the battery is powered down, the Infant Radiant Warmer will restore to default setup
when rebooting.

15.6 Alarm Response

When the device gives an alarm, refer to the following steps to take corresponding measures:
(1) Check the Pediatric's condition.
(2) Check the parameter being alarmed or the type of alarm.
(3) Identify the cause of the alarm.
(4) Remove the cause of the alarm.
(5) Check whether the alarm is eliminated.

Page 15-7
15.7 Alarm System
1. Parameter alarm
Alarm Alarm
Source Causes Measures
information level
User XX value is above the upper Check whether the alarm
XX is too high limits are appropriate, or the
selectable limit of the alarm limit
Pediatric's current
XX
User XX value is lower than the condition
XX is too low
selectabl lower limit of the alarm limit ! XX: on behalf of ECG,
SpO2, CO2, RESP, NIBP and
e
other measured values"
Check whether the electrode
Pediatric's ECG signal is too
and lead wire connection is
ECG lost High small for ECG signal analysis
normal, check the Pediatric's
current condition
The HR value of the baby is
smaller than the SpO2
setup Check if the
value in the apnea connection
monitoring
setup menu, and the between the electrode and
ECG HR apnea High duration the
is longer than lead wire is normal; check the
the
non-breathing alarm delay current condition of the baby.
alarm delay under the user
maintenance menu.
Check whether the electrode
The Pediatric appears an and lead wire connection is
ASYSTOLE High
arrhythmia of cardiac arrest normal, check the Pediatric's
current condition
The Pediatric's pulse signal Check the sensor connection
No pulse High is too small to analyze the and check the
pulse signal Pediatric'scurrent
SpO2
condition
The Pediatric's pulse signalis Check the sensor connection
SpO2 apnea High too small to analyze the and check the
pulse signal Pediatric's
current condition

Page 15-8
 The Pediatric's respiratory Check the lead wire
RESP apnea High signal is too small for RESP connection, check
signal analysis thePediatric's
RESP
current condition
The Pediatric's respiratory Check the lead wire
RESP
High signal is disturbed and RESP connection, check
ARTIFACT
signals cannot be analyzed thePediatric's
current condition

Page 15-9
 The Pediatric's respiratory Check the lead wire
CO2 CO2 apnea High signal is too small for RESP connection, check
signal analysis thePediatric's
current condition
No alarm Press the audio paused button
Others Alm pause time Alarm is artificially paused
level again to restore the alarm

2. Technical alarm
Alarm Alarm
Source Causes Measures
information level
Reboot again, if the error
XX module initialization
XX XX INIT ERR High persists, contact
error X
the
manufacturer for repair
XX module Reboot again, if the error
XX COMM
XX High cannot persists, contact
STOP
communicate with the the
main manufacturer for repair
system
XX module Reboot again, if the error
XX COMM
XX High cannot persists, contact
ERR
communicate with the the
main manufacturer for repair
system
The alarm limit of the XX
XX ALM LMT Contact the manufacturer
XX High parameter is
ERR forrepair
changed
unexpectedly
The measured value of the
XX parameter is outside the Contact the manufacturer
XX XX Overrange High
range of measurements forrepair
that
can be carried out
ECG lead wire is not Check the connection of ECG
ECG ECG lead off Low
connected well lead wires
SpO2 sensor has been off the Check SpO2 sensor
SpO2 finger off Low
finger connection
SpO2 sensor is not connected Check SpO2 sensor
SpO2 no sensor Low
well connection

Page 15-10
 Check SpO2 sensor
SpO2 sensor off Low /
connection
SpO2 After reset failure or device
NELLC
NELLCOR module restart, if the error persists,
ERR,RESETING Low
error,system contact the manufacturer
reset for
repair
Search pulse No alarm SpO2 sensor is not connected Check SpO2 sensor

Page 15-11
 level or the Pediatric moves the connection, and check the
arm Pediatric's current condition
Low Check and replace
CO2 Line
CO2 CO2 sampling tube blocked thesampling tube.
Blocked
If the fault
persists
Low The sampling tube is not Check and replace
CO2 No
connected or has thesampling tube.
Sampling Line
poor If the fault
contact persists
CO2 Temp Out Low Return to factory for
Module failure
Of Range maintenance
CO2 Span Cal Low Module failure Return to factory for
Error (Masimo) maintenance
CO2 Factory Low Module failure
Return factory for
Calibration
t
Lost (Masimo)
o
maintenanc
e

AG SPEED Low Module failure

OUT OF Return factory for
BOUNDS t
(Masimo) o
maintenanc
e

CO2 Pressure Low Module failure

Return factory for
Overrange
t
(Masimo)
o
maintenanc
e

CO2 Span Low

CO2 calibration... Return factory for
Calibrating...
rang t
(Masimo)
e(Masimo) o
maintenanc
e

Page 15-12
 Low Check and replace the
Replace CO2
adapter. If the fault persists,
Adapter Adapter exception
please contact the factory
(Masimo)
for
repair.
Low Check and replace the
CO2 No
The adapter is not connected adapter. If the fault persists,
Adapter
or has poor contact please contact the factory
(Masimo)
for
repair.
Low Enter the CO2 setup to
CO2 Need Zero
CO2 needs to be zeroed zero.Returning zero here is
(Masimo)
equal
to zero.
CO2 Software Low
Software error Restart
Error (Masimo)

Page 15-13
 Low
Check and replace the sensor.
CO2 Hardware
Hardware error If the fault persists, please
Error (Masimo)
contact the factory for repair.
Select the reset function in
NIBP
An error occurred duringNIBP the NIBP menu, if the error
SELFTEST Low
initialization persists, contact the
ERR
manufacturer for repair
Select the reset function in
NIBP COMM the NIBP menu, if the error
Low NIBP communication fails
ERR persists, contact the
manufacturer for repair
NIBP cuff is not connected
LOOSE CUFF Low Reconnect the NIBP cuff
well
Check the connection of all
NIBP cuff is not connected
parts, or replace a new cuff; if
AIR LEAK Low well, or gas leaks in the
the fault persists, contact
airway
the
manufacturer for repair
Curve measurement fails, Check the connection of all
AIR
unable to perform parts, or replace a new cuff; if
PRESSURE Low
measurement analysis and the fault persists, contact
ERROR
NIBP calculation the
manufacturer for repair
Check whether the Pediatric
Curve measurement fails, type setup are correct, check
WEAK unable to perform the connection of all parts, or
Low
SIGNAL measurement analysis and replace a new cuff; if the fault
calculation persists, contact the
manufacturer for repair
Curve measurement fails, Check the connection of all
RANGE unable to perform parts, or replace a new cuff; if
Low
EXCEEDED measurement analysis and the fault persists, contact
calculation the
manufacturer for repair
Check the connection of each
part and the Pediatric's
EXCESSIVE
Low Pediatric arm exercise condition, measure again, if
MOTION
the fault persists, contact
the

Page 15-14
 manufacturer for repair

Check whether the airway is

Over pressure Low Airway may be folded smooth and the Pediatric's
condition, measure again,
if

Page 15-15
 the fault persists, contact the
manufacturer for repair
Check the connection of each
Curve measurement fails,
part and the Pediatric's
SIGNAL unable to perform
Low condition, measure again, if
SATUATED measurement analysis and
the fault persists, contact
calculation
the
manufacturer for repair
Check the connection of all
PNEUMATIC There is air leakage in the parts, or replace a new cuff; if
Low
LEAK NIBP airway the fault persists, contact
the
manufacturer for repair
Check the connection of each
Curve measurement fails,
NIBP part and the Pediatric's
unable to perform
SYSTEM Low condition, measure again, if
measurement analysis and
FAILURE the fault persists, contact
calculation
the
manufacturer for repair
Check the connection of each
Curve measurement fails,
part and the Pediatric's
NIBP TIME unable to perform
Low condition, measure again, if
OUT measurement analysis and
the fault persists, contact
calculation
the
manufacturer for repair
Check whether the Pediatric
type setup are correct, check
It may be that the cuff used
CUFF TYPE the connection of all parts, or
Low does not match the set
ERR replace a new cuff; if the
typeof Pediatric
faultpersists, contact the
manufacturer for repair
Check the connection of each
Curve measurement fails,
part and the Pediatric's
MEASURE unable to perform
Low condition, measure again, if
FAIL measurement analysis and
the fault persists, contact
calculation
the
manufacturer for repair

Page 15-16
 Check the NIBP airway for
During the NIBP
NIBP RESET blockage, measure again, if
Low measurement, an illegal
ERR the error persists, contact
resetoccurred
the
manufacturer for repair
Other SKIN TEMP In the skin temperature Check if the alarm limit is
Medium
alarm TOO HIGH / mode, the difference appropriate, or the current

Page 15-17
inform LOW between the set condition of the baby
ation temperatureand the
stable skin
temperature is 0.5℃ / 1.0℃
Check the status of the baby
Temp
Temperature exceeds 38.5℃/ and skin temperature probe
abov High
101.3 ℉ and notify the physician
e38.5 ℃ /
promptly
101.3
℉
In manual mode, an
intermediate alarm for
“Check the patient” is
triggered every 12 minutes.
And it has not been canceled
Press the audio paused
within 3 minutes, the
High switch for alarm reset, check
intermediate alarm of
the status of the Pediatric
"Check the patient" will be
upgraded to advanced
alarm, and the power will be
CHECK automatically reduced to
BABY 15%.
Manual mode at any power
or in infant mode for 12 Press the audio paused
Medium minutes at full power switch for alarm reset, check
triggers a “Check the the status of the Pediatric
patient” intermediate alarm.
When the temperature of
the temperature probe Press the audio paused
High drops more than 1℃ within switch for alarm reset, check
60s, the heating power is the status of the Pediatric
reduced
to 15%

Page 15-18
 Do not disable the heating of
Remove the
the heating tube. Heat in
lamp holder Lamp holder removal alarm.
accordance with the normal
horizontally / After lamp holder removal,
Medium procedures, and perform
remove the and an alarm is given every
automatic alarm reset in the
lamp holder 5min.
horizontal position of the
vertically
lamp holder
Low power Promptly connect the AC
Medium Battery power is too low
level! Pls power supply and charge the

Page 15-19
charge battery, if the battery is
th charged for at least 6h, the
ebattery fault persists, please contact
the manufacturer for repair
POWER TOO
The battery batteryis too Promptly connect the AC
LOW,SYSTEM
High low, and the system will be power supply and charge the
WILL SHUT
forcedto shut down battery
DOWN
Check if there is any object
under the bed; if there is no
Check if there is
Objects may be caught object under the bed, restart
an object under High
underthe bed the device; if the warning still
the bed
exists, please contact the
factory for repair.
Check if the object is caught
under the lift; if there is no
Check if there is
Objects may be caught object under the lift, restart
an object under High
underthe lift the device; if the warning still
the lifter
exists, please contact the
factory for repair.
APGAR positive timing /
APGAR Time N High countdown time point Check if it is normal
arrives,alarm prompts for 3
seconds
Apnea awakening Check if the apnea wake-up
Apnea malfunction or fall off device is off the machine and
High
wakeu try to re-plug it. If it is not
pfailure resolved, contact the factory.

220V machine connected to Replace the AC power supply.

AC
High 110V power supply (AC If it is not resolved, contact
voltag
voltage input error) themanufacturer.
einput error

Other various system

exceptions (system Restart the device. If the fault
SYSTEM
High failureXX) XX are persists, please contact the
ERROR XX
numbers, representing factory for repair.
specific fault
types

Page 15-20
3. System prompt
Source Alarm information Alarm level Causes / Descriptions

The system prompt message is only

NIBP MANUAL MEASURE None for the device to prompt a
functionor a certain action
Checking ... None

PNEUM TESTING None

RESETUP None

PLEASE START None

RESET FOR ERR None

AUTO MEASURING None

CAL OVER None

Leakage Test Stopped None

Measure Stopped None

OVER PRESSURE None

RESET FAILED None

CO2 IS
Please wait xS for zeroing None
ZEROING
Paper runs out PRINTER PAPER LACK None Reload the printing paper

Paper Tray Not Paper compartment is not closed

None Close the paper compartment again
Closed well
Phy module has been removed, Physiological module has been
High
please confirm removed, please confirm
Please Set Device POWER High Set the power value of the warmer
Other
promp Set the temperature value of the
Please Set Device TEMP None
tmessages warmer
Demo None None

After 5 seconds, the prompt

0Kg ADJUST SUCCESS None
disappears automatically.
After 5 seconds, the prompt
0Kg ADJUST FAILURE None
disappears automatically.
SET VALUE ADJUST After 5 seconds, the prompt
None
SUCCESS disappears automatically.

Page 15-21
 SET VALUE ADJUST After 5 seconds, the prompt
None
FAILURE disappears automatically.
Horizontal Calibration After 5 seconds, the prompt
None
Succeeded disappears automatically.
After 5 seconds, the prompt
Horizontal Calibration Failed None
disappears automatically.
AC Power Failure High AC power supply stop

Body temperature probe

TEMP PROBE FAULT High malfunctions
or falls off
The lifting function is abnormal.
SYSTEM ERROR 28, 29, 30,
None Restart the machine, if the fault
32, 33
still
exists, contact the manufacturer
The tilting function of the bed is
SYSTEM ERROR 34, 35, 37, abnormal. Restart the machine, if
None
38 thefault still exists, contact the
manufacturer
Check if there is occlusion in the
Hand-free alarm silence area
None waved mute. Automatic
blocked
recovery
after abnormal release
Cause: The “Check Baby” advanced
Please check if the Temp Probe alarm is triggered by the skin
Popup prompt has been attached well with None temperature drop trigger.
baby Description: Click "OK" or "Cancel"
to close the window.

Page 15-22
 Chapter 16 System Setup

16.1 Main Menu

Click the “System Setup” at the bottom menu bar, and the main menu window pops up. Set each item. As
shown in the figure below:

Figure 16-1 Main menu

16.2 Option Setup

Figure 16-2 Option setup

Click the “System Setup” at the bottom menu bar, and select“Option Setup”, for setup the heartbeat
volume,key volume and LCD brightness as well as for automatic LCD brightness switch control.

Page 16-1
16.2.1 Hearbeat Volume

Heartbeat volume: Provide "OFF" and seven options from 1 to 6. After selecting the "1-6" levels, the
systemwill be prompted with selected heartbeat volume, among which “OFF” level indicates to turn off the
heartbeat sound.

16.2.2 Key Volume

Key volume: Provide "OFF" and seven options from 1 to 6. After selecting the "1-6" levels, the system will be
prompted with selected key volume, among which “OFF” level indicates to turn off the key sound.

16.2.3 LCD Brightness

LCD brightness: There are five LCD brightness, namely "1 ~ 10" levels, among which “10” levelmeans the
highest level of brightness.

16.2.4 Automatic LCD Brightness

When automatic LCD brightness is in "On" state, LCD brightness menu bar will not respond, and the display
will automatically adjust the LCD brightness. When automatic LCD brightness is in "Off" state, LCD brightness
menu bar will be in response, and the user can set the LCD brightness.

16.3 Device Setup

In the "System Setup", select "Device Setup", the menu shown below pops up, including: system Datatime

setup, module switch setup, apnea detection setup and print setup.

Figure 16-3 Device setup

16.3.1 System Datatime setup

Page 16-2
The system time is displayed in the format of year, month, day, hour, minute and second. Select the content
tobe modified, and select the time matching with your local standard time in the pop-up new option.

16.3.2 Module Switch Setup

The module switch setup has the following options:

ECG, SPO2, NIBP are not selectable.
(1) RESP: ON, OFF.
The Infant Radiant Warmer can monitor respiration when RESP is set to ON; when set to OFF; there is no
respiration display in the Infant Radiant Warmer's parameter area. RESP monitoring will be automatically
turned off duringCO2monitoring.
(2) CO2: ON, OFF.
The Infant Radiant Warmer can monitor CO2 when CO2 is set to ON; when set to OFF; there is no CO2 display
in the parameter area of the Infant Radiant Warmer interface (optional).

16.3.3 Apnea Monitoring Switch

Apnea monitoring switch: Physiological monitoring is possible when the switch is "ON"; apnea monitoring is
not available when the switch is "OFF".

16.3.4 Print Setup

Click the "System Setup" at the bottom menu bar. Select "Device Setup" to set the paper printing and
feeding speed and real-time recording time.
(1) Paper printing and feeding speed: There are two options, 25mm/s and 50mm/s.
(2) Real-time recording time: There are four options, "3s", "5s", "8s" and "Continuous". "Continuous"
means that once you click "Print" at the bottom menu bar, the printer will continuously output
waveforms and parameter values until you click "Print" again.
(3) Grid swith: ON/OFF.

16.4 Device Information

Device information is primarily for viewing version information of software run by the Infant Radiant Warmer,
so as to facilitate the manufacturer’s maintenance and traceability of the Infant Radiant Warmer.

Page 16-3
 Figure 16-4 Device information

16.5 Device Maintenance

Click the "System Setup" at the bottom menu bar and select "Maintenance". Enter the password: 5188, press
"Enter" button to enter the "Maintenance" menu.

Note
l The manufacturer’s default Pediatric configuration has been set up at the time of delivery.
Users cannot be changed, but can call directly. Users can set their own default setup as needed.

Figure 16-5 Device MAINTAIN

(1) Language: Chinese (Simplified), English, French, Russian, German, and Chinese (Traditional).
(2) Notch filter: 50Hz/60 Hz.
(3) Datatime setup: Enter “maintain” → “Datatime setup”, set the system time according to local time,
including year, month, day, hour, minute, second, date format, time format. After selecting “enter”, the
setup take effect immediately.
(4) Screen adjust: The touchscreen calibration screen is displayed when the SCREEN ADJUST menu is

Page 16-4
 clicked. Click the five calibration points on the screen as prompted. After successful calibration, the
system returns to the main menu.
(5) Auto alarm: on/off. Intelligent alarm gradation is a characteristic of our alarm system. For parameters
of intelligent alarm gradation, user can simultaneously set the alarm limit ranges of high and medium
alarms without setup alarm levels. When the measured parameter value is beyond the normal range,
the device will automatically judge which alarm level range the measured parameter value belongs to,
and then will generate an alarm of the corresponding level.
(6) Apnea alm delay: when the infant’s breathing or blood oxygen or heat rate meet the staring apnea
condition, after a certain delay, the corresponding alarm is triggered to wake up the vibrate of apnea,
the user can set the delay time range of “off, 10s~40s”, incremental gradient is 5s, default is 15s.
(7) 0kg cal(calibration): 0kg Calibration
• Start the incubator.
• Connect the weighing cable plug to the weighing socket on the interface panel.
• Ensure that no articles are placed on the bed. Access the System Setup menu, choose 0kg Cal. If the
calibration fails, a “Calibration failure” notification is displayed. In this case, you need to perform the
calibration again.
(8) Set point cal(calibration):
• Ensure that 0kg Cal is successfully performed.
• Put the weights or article with its weight being known on the bed mattress, click Set Value Calibration
and manually input the weight value of the weights or article. Click Enter to start the calibration. The
weight of the object for calibration placed on the weighing scale shall be 3000g to 8000g, and the
default value of the system is the corresponding value of the weight (the default value is 5000g).
• If the calibration fails, a “Set Value Calibration Failure” notification is displayed. In this case, you need
to perform the calibration again.
(9) NIBP Calibrate: See the section "NIBP Calibration" for details.
(10) Pneumatic: See the “NIBP Leakage Detection” section for details.
(11) ECG cal: See the “ECG Calibration” chapter for details.
(12) Alarm sound pause (minutes): The default is 2 minutes. The optional time interval is 1 to 15 minutes,
but the risk of modification time is borne by the user.
(13) Adopt factory default ped config: Adopt the default factory ped configuration, select this item to enter
the “Adopt factory default ped config” dialog box, select “no”, that is, abandon the current operation,
the system still keeps the original configuration content unchanged, select “yes”, it will be adopted The
factory default setup for the neonate configuration will put the original configuration to be overwritten.
(14) Adopt factory default neo config: Adopt the default factory neonate configuration, select this item to
enter the “Adopt factory default neo config” dialog box, select “No”, that is, abandon the current
operation, the system still keeps the original configuration content unchanged, select “Yes”, The
neonate configuration will be used with the factory default setup, and the original configuration will be
overwritten.
(15) User default ped config: Default user paediatric configuration, when the user runs the user paediatric

Page 16-5
 configuration for the first time, you need to select “Save configuration as user default configuration”.
After confirming, this operation can be performed. Otherwise, the system configuration cannot be
replaced with the user paediatric configuration. .
(16) User default neo config: Default user neonate configuration, when the user runs the user's neonate
configuration for the first time, you need to select “Save Current as User Default Configuration”. After
confirming, this operation can be performed. Otherwise, the system configuration cannot be replaced
with the user Neonate configuration.
(17) Save the current configuration as the user default configuration: When the user first replaces the
system configuration with the user's neonate configuration or user's paediatric setup, select this option
to save the configuration set by the user.
Attention
l The default factory ped configuration and the default factory neonate configuration are set by
the manufacturer when it leaves the factory. The user cannot change it and the user can call it
directly. Users can set the user default configuration as needed.

16.5.1 NIBP Calibration

The manufacturer recommends using a calibrated pressure gauge (or mercury sphygmomanometer) with a
precision above 1mmHg for calibration. Select “Calibration" to start NIBP calibration. Meanwhile, this item
changes to “Stop NIBP Cal (Calibration)". If you click "Stop NIBP Cal (Calibration)" at this time, the system will
stop calibration.

Warning

l Calibration of NIBP measurements shall be performed every two years (or as per your
hospital's maintenance charter). The following details shall be checked for performance.

Calibration steps of the pressure sensor:

Replace the cuff with a metal container with a volume of 500ml ± 5%. A calibrated standard pressure gauge
and a ball-type air pump with a T-connection and an inflation tube are connected to the NIBP jack on the
module with an error of less than 0.8mmHg. Set the device to "Calibrate" mode and then use a ball-type air
pump to inflate the pressure in the metal container to 0, 50 and 200mmHg, respectively. The difference
between the standard pressure gauge value and the pressure value indicated by Infant Radiant Warmer shall
bewithin 3mmHg. Otherwise, contact Tende's service engineer.

Figure 16-6 Connection diagram for NIBP calibration

Page 16-6
16.5.2 NIBP Leak Detection

It is used to detect whether there are any leaks in the NIBP measuring pump. When connecting to the NIBP
cuff, it can be used to start the NIBP inflation process, so as to find out whether the closed condition of the
NIBP gas circuit is in good condition. If the leak test is passed, the system will make no prompts; if it fails,
there will be a corresponding error message in the NIBP information area.
Leak detection process:
(1) Connect the cuff to the NIBP vent on a five-parameter module well.
(2) Wrap the cuff around an appropriately sized cylinder.
(3) Enter the "NIBP Setup" menu.
(4) Select "Leak Detection". At this time, "Leak detection ..." will be displayed below the NIBP parameter
area on the screen, indicating that the system starts to perform the leak detection.
(5) The system automatically inflated to a pressure of 180mmHg.
(6) About 20s later, the system automatically opens the vent valve, indicatingthe completion of the
leakdetection.
If there is no prompt in the NIBP parameter area, the system has no leaks. If "Pump leaks ..." is displayed,
there may be a leak in the gas circuit. In this case, the operator shall check whether the entire connection is
loose. After confirming the connection is correct, conduct leak detection again. If there is still a fault prompt

appears, contact the manufacturer for repair.

Figure 16-7 Connection diagram for NIBP leak detection

Warning
l This leak detection is different from that described in the EN 1060-1 standard. It is for users to
easily detect whether the leaks occur when the NIBP is inflated. If at the end of the detection,
the system displays NIBP gas leaks, contact Tende's service engineer.

16.5.3 ECG Calibration

(1) Click “maintain”, then select “ECG Cal (Calibration)” to set it to calibration status.
(2) To stop calibration, you need to go back to “maintain” menu to select “Stop ECG Cal (Calibration)”.

Note
l During ECG calibration, the Pediatric cannot be monitored.There willbe a prompt in the
technical alarm area on the Infant Radiant Warmer’s screen: ECG calibration.

Page 16-7
16.6 Demo Mode
Click the "System Setup" at the bottom menu bar and select "Demo Function". The “Demo Mode” dialog box
pops up. Enter the correct password, then press "Enter" to enter the demo function’s operating status of the
device.

Warning
l Demo waveforms are simulation demo waveforms set by the manufacturer only for demonstrating
machine performance and helping users with training. In actual clinical use, the demo function is
disabled because it may cause the medical staff mistakenly believe that it is the monitored
Pediatric waveform and parameters, which may affect the Pediatric monitoring and
delay the diagnosis and treatment of the disease. Therefore, this menu has a password.

Page 16-8
 Chapter 17 Resuscitation System

17.1 Operation Panel

1 14

13
3 12
6

4 11

5 10

8 9

Figure 17-1 Front operation panel

Page 17-1
 15 17

16

Figure 17-2 Rear operation panel

1. Vacuum switch: Control the on and off of the vacuum-driven gases;

2. Vacuum regulating knob: Vacuum regulation;
3. Medical gas switch: Control the on and off of the oxygen therapy and resuscitation function;
4. Oxygen therapy gas flow regulating knob: Regulate the flow of mixed gas during oxygen therapy;
5. Oxygen therapy connector: Connect the device with the oxygen tube;
6. Airway pressure gauge: Display PIP during resuscitation;
7. Oxygen concentration regulating knob: Regulate the oxygen concentration of mixed gas;
8. Air cylinder pressure gauge: Display the pressure value of air cylinder;
9. Oxygen cylinder pressure gauge: Display the pressure value of oxygen cylinder;
10. Resuscitation fittings: Connect the device with 15mm corrugated gas pipe;
11. Resuscitationgas flow regulating knob: Regulate the gas flow of resuscitation;
12. PIP regulating knob: PIP regulation;
13. PIP limit: Control whether PIP is allowed to be greater than 30cm H2O;
14. Vacuum gauge: Display the vacuum value;
15. Oxygen source connector: Connect the oxygen source hose;
16. Vacuum connector: Connect the vacuum suction tubing assembly;
17. Air source connector: Connect the air source hose.

Page 17-2
17.2 Pre-operational Check of the Resuscitation System

Warning
l Before using this device, read this Manual and understand the operation and maintenance of
each component.
l If the pre-operational test fails, do not use the device, and contact the Company.
l It is forbidden to use the device for the patient in the event of device self-built or system test
failure and breakdown.
l When operating the device, clean and dry medical grade gas must be used. Contaminants and
moisture can cause poor operation. Medical grade air must be USP compressed air or ANSI Z86.1
1973 Class F air with a water vapor content not exceeding the system dew point below 5°F below
the minimum temperature of the environment in which the conveying system is located.
l The water vapor content in medical air or oxygen supplied to the equipment shall not exceed
5.63g / m3 (water / non-condensing gas).
l When repairing this equipment, please use the lubricating oil specified by the Company.
l Prior to and during use of the patient, the oxygen concentration of the delivered gas shall be
checked at the intended point of use.

17.3 Accessory Installation

Warning
l The accessories of this equipment shall be installed for the first time by the engineer appointed
by the manufacturer, and shall be assembled by the hospital in the future.
l To ensure the safety of neonates, make sure that the gas flow is within the set range before
attaching the accessory to the neonate.

The whole process of accessory installation can be divided into three stages: vacuum stage, oxygen therapy
stage and resuscitation stage. When Pediatrics needs to be treated in more than one phase, the accessories
of the corresponding phase are installed successively. Prior to use, the device is threaded onto the air /
oxygen interface on the back of the device according to the air / oxygen source identification symbol. The
device accepts central air supply (fresh air or oxygen) from the hospital or a gas cylinder with a control valve.

17.3.1 Vacuum Stage

When performing vacuum operation on the Pediatric, it is necessary to install a collection of Pediatric
secretions of the disposable anti-down liquid bottles and disposable filters. (The accessories provided by the
Company do not include disposable anti-reverse suction fluid bottle and disposable filter. The

Page 17-3
installation diagrams are for reference only. The operator can configure the overflow bottle as required
according to the actual needs.)
Installation steps are as follows:
1. Connect the neonatal suction catheter to the patient-end interface of the disposable anti-reverse
suctionfluid bottle;

Figure 17-3 Vacuum stage 1

2. Connect the hose to the intake end of the disposable filter and connect the other end of the hose to
thesuction side of the disposable liquid collection bottle;
3. Use the hose to connect the vacuum end of the disposable anti-reverse suction fluid bottle to the
vacuumend in the middle;
4. Connect the hose to the output of the disposable filter;

Figure 17-4 Vacuum stage 2

5. When connected, connect the hose connected to the output of the disposable filter to the

Page 17-4
 Note
l In the overflow anti-reverse suction device, the end connected to the anti-reverse suction device
must be connected to the device.
l The hose with inner diameter of 6mm is connected to the negative pressure connector, the
insertion range is 11~13mm. During operation, do not pull the hose on the collection bottle to
avoid air leakage, which will affect the performance of the product.

17.3.2 Resuscitation Stage

Oxygen bellows, fittings, PEEP valves, and neonatal masks are required for resuscitation of Pediatrics.
Installation steps are as follows:
1. Connect the port on one side of the PEEP valve to the neonatal mask;

Figure 17-5 Resuscitation stage 1

2. Once connected, connect the other end of the PEEP valve to the connector and connect to the

oxygenbellows.

Figure 17-6 Resuscitation stage 2

3. Finally, connect the PEEP valve with a neonatal mask to the resuscitation fitting on the operator panel
viaan oxygen bellows.

17.3.3 Oxygen Therapy Phase

When oxygen therapy is performed on the Pediatric, the oxygen therapy tube is connected to the oxygen
therapy adapter on the operation panel and the oxygen mask / hood on the other side.

Page 17-5
17.4 Alarm
When the pressure difference between oxygen or air is above 140 ± 20kPA or if one of the two gases fails, the
alarm will sound an alarm similar to metal friction.
When the mechanical alarm sounds, check whether the gas source is connected or replace the gas source
untilthe alarm sound disappears.

17.5 Device Startup

Connect the accessories of the resuscitation system properly. Connect the device gas source system to start
ventilation. Before use, it is necessary to check the pressure of the gas source to ensure adequate operating
gassupply. The input pressure of the oxygen and air sources shall is between 280kPa and 600kPa.

Note

• In accordance with the functions, the resuscitation system is mainly divided into two parts,
namely vacuum sunction and resuscitation. The device has three external functional fittings and
two gas inlet fittings, namely vacuum suction connector, resuscitation connector, oxygen therapy
connector, oxygen source connector and air source connector.
• This device must be supplied with medical gas. Do not use atmospheric or unfiltered gas.

17.6 Vacuum Suction System

1. Follow the steps to connect the vacuum suction components and connect the oxygen and air sources;
Figure 17-7 Vacuum suction system 1

2. Rotate the vacuum pressure regulating knob counterclockwise;

3. Turn on the vacuum switch;
4. Put on the gloves to blockthe vacuum suction tube;
5. Rotate the vacuum pressure regulating knob clockwise;

Page 17-6
 5

Figure 17-8 Vacuum suction system 2

6. Observe the vacuum pressure on the panel and set the vacuum to the desired value;

Figure 17-9 Vacuum suction system 3

7. Perform vacuum suction operation on the neonatal patients;

8. Turn off the vacuum switch after operation, and cut off the gas source.

Note

• The maximum vacuum pressure of the device is 150mmHg. The inspiratory flow shall not be
greater than 20L/min. During vacuum operation, medical staff can choose the appropriate
vacuum value as required. If too high, it will bring trauma to the neonates; if too low, it may not
be able to achieve the purpose of vacuum suction. The medical staff for operation must undergo
a professional training and a certain degree of practical operation.

• For safety, thevacuum suction time shall not be greater than consecutive 10s.
• Vacuum pressure test must be performed before use.
• This device does not provide the necessary accessories for the vacuum suction assembly. If
necessary, the user shall provide or purchase them. The accessories provided or purchased
must comply with the ISO 10079-3 standard.

Warning
• Liquid flows into the resuscitation device through a pipe. Contact the Tende-designated
customer service agency or local agents.

17.7 Resuscitation Setup, Checking and Use

17.7.1 Alarm Check

The resuscitation system needs to be tested for alarm before using the resuscitation system:

Page 17-7
the air terminal is closed, while the oxygen source onthe oxygen terminal is opened, the system will give
analarm sound to prove that the alarm system is in good condition.

17.7.2 Parameter Setup and Check before Resuscitation

Warning

l Do not reuse disposable tubing components. Cleaning and reusing disposable tubing components
can damage the tubing and increase the risk of patient infection.
l When using this product, select the appropriate PIP, oxygen concentration and gas flow. If
improper selection, it may cause serious damage to neonatal patients. Operation of medical staff
must undergo a professional training and a certain degree of practical operation.
l Consult your doctor to set PIP properly.
l This function does not apply to unattended patients.
l Recommendations for ILCOR / AHA / ERC guidelines [16] shall be used prior to use to determine
the applicability of different resuscitation devices used in cardio-pulmonary resuscitation.

1. Connect the oxygen bellows to the resuscitation fitting on the front panel of the resuscitation
system,following the step-by-step installation of the resuscitation assemblies;
2. Turn on the medical gas switch and rotate the resuscitation knob to adjust the flow at the outlet of
theresuscitation connector (check the PIP and PEEP values whenever the flow is adjusted);
3. Check the maximum suction pressure (ensure that the PEEP valve’s back cover remains attached to
thePEEP valve):
1) Fully fit the mask to the console and block the control rotation hole on the rear cover of the
PEEPvalve.
2) Press the PIP limit button, and then rotate the PIP knob to the maximum value;
3) Observe the airway pressure gauge values to see whether the maximum PIP is within the range of 45
± 5 cmH 2O.

Note
l When the input connector on the wall is reversedlyconnected with the input end of the gas
cylinder, the gas bottle will leak until the gas cylinder is empty.
4. Continue to block the control rotation hole on the back cover of the PEEP valve and fit the mask
completely to the console. Rotate thePIP knob on the front panel counterclockwise to the PIP limit
button. At this time, observe whether the value of the airway pressure gauge is within the range of 30 ±
4cmH 2O.
5. When adjusting the PEEP valve, remove the hand from the PEEP control knob, and turn the control
knobto set the desired pressure value.

Page 17-8
 Figure 17-10 Check before use for resuscitation1

Warning
l The resuscitation operation requires proper frequency and pressure.
l Note whether there is an alarm (air-oxygen mixer alarm) before connecting the resuscitation
system to the patient.

6. The oxygen concentration knob can regulate the oxygen concentration within the range of 21% to 100%;

Figure 17-11 Check before use for resuscitation 2

7. Turn off the medical gas switch, and cut off the gas source. Clean and disinfect non-disposable
accessories.

Warning

l If the resuscitation system fails during apnea resuscitation, replace it with a manual resuscitation
device (traditional bag and mask resuscitation device) with inflation or flow control.
l Set the flow, PIP and PEEP parameters before use.
l Beforeused in the patient, check whetherthe resuscitation system is tidy and correct.
l Before use, confirm whether the PIP and PEEP in use will cause harm according to the patient's
specific conditions.

Page 17-9
17.7.3 Use of the Resuscitation Function

Warning
l Confirm the functions of all knobs, setup such as flow, pressure and oxygen before use.

1. Turn on the medical gas switch for the air / oxygen source and the resuscitation system;
2. Insert the appropriate mask into the PEEP valve and the other end into the oxygen bellows with
thenipple;

Figure 17-12 Use of the resuscitationfunction 1

3. Placing a mask over the Pediatric's face, press and hold the control knob hole on the back of the
PEEPvalve while aspirating;

Figure 17-13 Use of the resuscitationfunction 2

4. When exhaling, release the finger holding the control knob hole;

Page 17-10
 Figure 17-14 Use of the resuscitationfunction 3

Warning

l Avoid blocking the control knob for a long time to prevent the inhaling time from being too long.
l Follow the neonatal resuscitation guidelines for apnea (at a frequency of 40-60 beats per minute;
if the Pediatric has spontaneous breathing, it can be gradually reduced and stop positive pressure
artificial respiration).
l If the resuscitation system fails and cannot be used before using the resuscitation function, it is
advisable to use other methods to rescue such as resuscitation ball.
l If during use, the positive pressure at the outlet of the resuscitation system disappears and the
patient has spontaneous breathing, it may cause internal contamination to the machine. Repair
and disinfect it in time.

5. Change the PIP value

i. Move the mask away from the patient;

Figure 17-15 Use of the resuscitationfunction 4

ii. Fully fit the mask to the console and block the PEEP rotation control hole;

Page 17-11
 Figure 17-16 Use of the resuscitationfunction 5

iii. Re-adjust the PIP value

a. Increase pressure clockwise
b. Reduce pressure counterclockwise
6. How to use the resuscitation system to flexibly set the oxygen flow
iv. Set the meter flow and oxygen concentration values according to your operating plan
v. Place the mask beside the Pediatric face

Warning
l After flow regulation, check the PIP and PEEP values.
l Always follow thehospital, local and national guidelines for resuscitation process.
l When the mask is on the baby's face, do not adjust PIP and PEEP.

Note
l When the resuscitation system is not in use, turn off the medical gas switch or the vacuum
switch.

17.8 Oxygen Therapy

1. Connect the aerobic therapy tube in accordance with the procedure and after the inspection in
accordancewith 3.7.1.Connect the oxygen mask / headgear on the other side and then open the
medical gas switch.
2. Adjust an appropriate oxygen concentration of the oxygen and air mixture (range: 21% -100%)
3. Rotate the gas regulating knob for oxygen therapy clockwise to regulate to a desired flow value
(flowrange is 0-15L/min).
4. Turn off the medical gas switch, cut off the gas source. Disinfect and clean the non-disposable
accessories.

Page 17-12
 Note

• When connecting oxygen therapy equipment, accessories for oxygen therapy equipment shall
come with a safety valve that is not supplied by the equipment itself. Care shall be taken to
select the appropriate oxygen concentration and gas flow during oxygen therapy. Improper
selection can cause irreversible damage to neonatal patients.

• Confirmation of oxygen concentration shall be realized by an oxygen analyzer or hospital-based

protocol. Regularly check whether the oxygen concentration of the delivered gas meets the
requirements.
• In the case of oxygen therapy, the patient's gas must be tested using an oxygen analyzer.

Page 17-13
 Chapter 18 Care and Maintenance

18.1 Maintenance Inspection

Before using the Infant Radiant Warmer, the following checks shall be performed:
a) All controls on the Infant Radiant Warmer’s panel shall be properly and securely installed, and
functionsshall be in accordance with those indicated on the panel;
b) There shall be no scratches and cracks on the coatings, platings and injection molded parts on the
outersurface of the Infant Radiant Warmer;
c) The text and markings of the Infant Radiant Warmer shall be clear, accurate and secure; the
fastenersshall not be loose;
d) Check all exposed wires, insert parts and accessories;
e) Check all the functions of the Infant Radiant Warmer that may be used to monitor the Pediatric, and
keepthe Infant Radiant Warmer in good operating condition.
If evidence of damage to the Infant Radiant Warmer’s function is found, then the Infant Radiant Warmer
mustnot be used for any monitoring of the Pediatric, contact your hospital's biomedical engineer or the
Company. Every 6-12 months, or after each repair, a thorough inspection of the equipment, including
functional safetychecks, must be carried out by a trained and qualified service technician.
All safety inspections or repairs that require disassembly of the Infant Radiant Warmer shall be performed
by a qualified service technician. Non-professionals may cause a risk of electric shock and damage to
equipment while disassembling and servicing this Infant Radiant Warmer.
Tende will conditionally provide the circuit diagrams at the user's request to assist the user in self-
repairing of the Infant Radiant Warmer’s user-serviceable components, which are classified by a qualified and
trained service technician.

Warning

l The hospital or institution using this Infant Radiant Warmer shall follow this Manual, otherwise it
may cause invalid and unpredictable effects on the functioning of the equipment and may
endanger personal safety.
l Clean the area between the power plug terminals at least once a year. If dust accumulates
between the power plug terminals, it may cause a fire.

18.2 Maintenance Schedule

The following tasks can only be completed by the Company-authorized professional maintenance personnel.
When the following maintenance is required, contact the maintenance personnel in time. Equipment must
be cleaned and disinfected before testing or servicing.

Page 18-1
 Testing and maintenance items Frequency
Perform safety inspection according to At least once a year. After the Infant Radiant Warmer is
IEC 60601-1 replaced or when needed.
NIBP leak detection At least once a year, or as needed.
At least once a year, or when you suspect the
NIBP calibration
measurement is inaccurate.
At least once a year, or when you suspect the
ECG calibration
measurement is inaccurate.
Performance testing of all measurement At least once a year, or when you suspect the
functions measurement is inaccurate.
Battery performance test Refer to the battery-related section.

Touch screen calibration At least once a year, or after changing the touch screen
According to the requirements of
Chapter18 in IEC 60601-1
At least once a year
(GB9706.1), the
protective earthing impedance of the
test
equipment shall not exceed 0.1Ω.
According to the test method in 19.4 of
IEC 60601-1(GB9706.1), the earth
leakage current of the test equipment
At least once a year
shall not exceed 0.5mA under normal
conditions, and shall not exceed
1mA
under single fault condition.
According to the test method in 19.4 of
IEC 60601-1(GB9706.1), the patient
leakage current of the test equipment
At least once a year
shall not exceed 0.1mA under normal
conditions, and shall not exceed 0.5mA
under single fault condition.
According to the test method in 19.4 of
IEC 60601-1 (GB9706.1), the patient
leakage current of the test equipment
At least once a year
(network voltage of applied parts) shall
not exceed 5mA under single fault
condition.

Page 18-2
 The phototherapy apparatus is maintained and
functionally tested for a total of 10,000 hours of
Phototherapy apparatus
phototherapy as set inside the device. If ebi test is
less
than 25%, contact the manufacturer.

Page 18-3
 Chapter 19 Cleaning and Disinfection
Only use the materials and methods approved by theCompany listed in this Chapter for equipment cleaning
or disinfection. The Company does not provide any warranty if damage is caused by use of non-approved
materials or methods.
The Company is not responsible for the effectiveness of the listed chemicals or methods as means of
controlling infection. For methods of controlling infection, consult your hospital's infection prevention
department or epidemiologist. See also all local policies for your hospital and country.

19.1 Overview
Keep the Infant Radiant Warmer andi its accessories free of dust. After cleaning, please double-check the
equipment. If you notice any signs of aging or damage, stop using it immediately. If you need to send it back
to Tende for repair, clean it first. Please observe the following precautions:

Dilute detergent and disinfectant according to manufacturer's instructions, or use as low a

concentration as possible.
Do not allow liquid to enter the shell.
Do not allow any liquid to be poured on any part of the Infant Radiant Warmer or its accessories.
Do not immerse Infant Radiant Warmer in liquid.
Do not use abrasive materials and bleach, and any strong solvents (such as acetone or acetone-
containing detergents).

19.2 Disassembly of the Infant Radiant Warmer

Warning
l Always turn off the power supply and disconnect the AC power before cleaning the Infant Radiant
Warmer or sensor, so that the warmer can be fully cooled.
l Before removing or cleaning the Infant Radiant Warmer or its components, it must be ensured
that there is no Pediatric in the Infant Radiant Warmer and its corresponding parts have been
removed.
l Before removing or remounting the bottom of the device, cut off the power.
l If any contamination of the device is found, it shall be cleaned and disinfected to prevent
infection.
l Always clean and disinfect the device before using it on another patient.

Page 19-1
 Caution
l To prevent damaging the Infant Radiant Warmer.
l Do not use strong solvents, such as acetone.
l Most cleaners must be diluted before use. Dilute as instructed by the manufacturer.
l Never use abrasive materials (such as steel wool or silver polishing agent).
l Do not allow any liquid to enter the Infant Radiant Warmer. Contact your service representative
or the Company immediately， if you accidentally pour liquid on the Infant
Radiant Warmer or itsaccessories.
l Do not leave any cleaning solution on any part of the Infant Radiant Warmer.
l Electrostatic discharge can easily damage the electronic devices in the microprocessor controller.
Although these devices are adequately protected, they may be damaged if they are removed
beyond the level recommended for cleaning and maintenance.
l Do not disassemble the probe at will. All probes must be kept in the correct position for correct
operation.

Note
l For cleaning and disinfecting reusable accessories, see the Manual provided with the accessories.
l The Infant Radiant Warmer and its sensor surface can be wiped with medical alcohol, air-dried or
wiped with a piece of clean, dry and lint-free cloth.
l The Company is not responsible for the effectiveness of these chemicals as a means of controlling
infectious diseases. Please consult with your hospital's infectious disease control leader or
infectious disease specialist.
l The Infant Radiant Warmer in use shall be wiped and disinfected on the inside and outside every
day, and disinfected every 7 days.
l To protect the environment, disposable accessories must be recycled or disposed of properly.

If the Infant Radiant Warmer is contaminated with Pediatric body fluid, check your infection control
procedures. Wear protective clothing and goggles, or use special disinfectant and cleaning procedures.
Disassembly steps:
(1) Turn the power switch off and disconnect the power cord from the power outlet.
(2) If the Infant Radiant Warmer was originally on, it shall be cooled for at least 30min.
(3) Unplug the temperature probe and other probe sockets or connectors from the outlet and the
Pediatricguard.
(4) Put down thePediatric guards around.
(5) Lift the tray off the foundation.

Page 19-2
19.3 Cleaning and Disinfection of the Infant Radiant Warmer
Infant Radiant Warmer shall be kept clean. It is recommended to regularly clean the outer surface of the
cabinet, especially in areas with severe environmental conditions or large sandstorms, and shall increase the
frequency of cleaning. Consult before cleaning or understanding of the hospital on the relevant provisions of
equipment cleaning.
l Cleaning steps:
Ø Turn off the power and disconnect the power cord
Ø Wipe the surface of the Infant Radiant Warmer with a soft cloth after absorbing the right amount
ofdetergent.
Ø Wipe the display of the Infant Radiant Warmer with a soft cloth after absorbing the right amount
ofdetergent.
Ø If necessary, use a piece of soft, dry cloth to wipe excess detergent.
Ø Place the device in a cool and ventilated place for air drying.
l Disinfection
To avoid long-term product damage, we recommend disinfecting the product only if it is deemed necessary
byyour hospital's procedures. We also recommend that disinfected products be cleaned first.
The following table shows the cleaning agents available for each part of the Infant Radiant Warmer and its
accessories:

Cleaning / Disinfection site Optional cleanser/ disinfectant

Transparent door panel

shell

power cable

Card box housing

n hydrogen peroxide 3%
ECG cable
n glutaraldehyde 2%
Body temperature probe n sodium hypochlorite 0.5%
Blood oxygen probe

Mainstream CO2 module

Sidestream CO2 module

Page 19-3
 Warning
l Using only the recommended cleaners and disinfectants in this Manual. The use of other cleaners
and disinfectants can cause damage to the Infant Radiant Warmer, or result in a safety hazard.
l Before cleaning the Infant Radiant Warmer, you must turn off the power and disconnect the AC
power supply.
l Do not use acetone to clean the Infant Radiant Warmer.
l Do not immerse or spray the liquid directly on the Infant Radiant Warmer.
l Do not leave the disinfectant on any surface of the equipment and its accessories. If any, wipe it
off immediately with a damp cloth.
l Do not mix detergent; otherwise it will produce dangerous gas.
l Avoid cross-infection, disposable accessories can not be cleaned and disinfected before use.
l To protect the environment, single-use accessories must be properly disposed of in accordance
with local laws and regulations.
l After cleaning, if a sensor cable is damaged or aging, new cables shall be replaced.
l Do not sterilize the Infant Radiant Warmer and any accessories at a high temperature.
l Do not use EtO (ethylene oxide) to disinfect the Infant Radiant Warmer.
l Do not use any cleaning solutions other than those recommended here, which may cause
permanent damage to the Infant Radiant Warmer, sensors and cables.
l Do not immerse the sensor or connector in any solution for cleaning or disinfection.
l To prevent the cleaning liquid and dust from entering the ISA gas analyzer through the LEGI
interface, always connect the Nomoline sampling tube when cleaning the ISA analyzer. Do not
immerse the ISAsidestream gas analyzer into liquid for disinfection.
l Nomoline sampling tubes are not sterile. To avoid damage, do not autoclave any part of the
sampling tube.
l Before cleaning the IRMA probe, remove the disposable IRMA airway adapter. Do not sterilize the
IRMA probe or immerse it into the liquid.
l IRMA oxygen cells and IRMA airway adapters are not sterile. Do not autoclave the device as
this may result in damage to the device.

Caution
l If you accidentally dump the liquid on the Infant Radiant Warmer or its accessories, contact
your service representative or the Company immediately.

Page 19-4
19.4 Cleaning and Disinfection of Individual Components

19.4.1 Probe (Reusable)

Caution
l When cleaning, be careful not to pull or bend the leads on the top of the probe.
l Do not autoclave or sterilize the temperature probe with gases.
l Do not apply cold disinfectant or cleaning solvent to the probe interface. Do not immerse the
probe in liquid detergent.

Note
l If you are using a disposable probe, do not allow repeated disinfection or re-use.
l Single-use probes cannot be washed.
l To protect the environment, disposable probes shall be recycled or disposed of properly.

Soft cloth shall be used when cleaning reusable probes. Dip disinfectant shall be used safely on the
probe materials. Gently wipe all cleaning solvents after cleaning. (The body temperature probe is
recommendedto be changed every two years)

19.4.2 Cleaning and Disinfection of NIBP Cuff

The airbag must be removed before cleaning.

Sleeves can be washed by machine with warm water and mild detergent or hand-washed. Hand wash can
extend the service life. The airbag can be wiped clean with a wet cloth dampened with water. Dry naturally
after cleaning.
Sleeves can be sanitized using a wet cloth dampened with 70% ethanol or 70% isopropanol. Long-term use
of disinfectants may cause the cuff to appear discolored.

Warning
l Do not squeeze the rubber tube on the cuff.
l When cleaning the airbag, be careful not to allow the liquid to enter the airbag.
l Sleeves cannot be dry-cleaned.
l Disposable cuffs must be properly disposed of according to local laws and regulations.
After cleaning, please refer to the following method to reload the airbag into the sleeve.
1. Put the airbag on the head end of the cuff first, so that the rubber tube and the large opening on the
longend of the cuff are in a line.
2. Then roll the balloon longitudinally and insert it into the large opening of the cuff;
3. Hold the skin tube and cuff, shaking the entire cuff until the balloon is in place;
4. Lead the skin tube into the cuff, pierced through the hole lining out. See the figures below:

Page 19-5
19.4.3 Cleaning and Disinfection of SpO2 Sensor

Caution
l Do not autoclave the sensor.
l Do not immerse the sensor in the liquid.
l Do not reuse the sensor or cable if it is damaged or deteriorated.
l If ECG cable is damaged or aged, replace it with a new one.
Cleaning:
The appearance of the sensor can be stained with cotton balls or soft cloth moistened with medical
alcohol,and then dry with a dry cloth. The sensor's LED and receiver can also be cleaned in the same way.
The cable can be cleaned and disinfected with 3% hydrogen peroxide or 70% isopropanol. The active reagent
is equally effective. The connector cannot be immersed in the above solution.

19.4.4 Cleaning of Printer

After a long-term use of the printer, paper dust and impurities build up on the printhead, affecting the
qualityof the recording and the life of the printhead and roller.
Cleaning:
1) Before cleaning, take measures to prevent damage to the printer caused by static electricity;
2) Open the printer door, remove the record using a cotton ball dipped in the right amount of alcohol;
3) Gently wipe the surface of the thermal head of the printhead;
4) Wait for the alcohol to dry completely, reload the recording paper and close the printer door.

Note
Ā Do not use anything that will damage the thermal components, such as sandpaper.
Ā Do not squeeze the thermal print head hard.

Page 19-6
 Chapter 20 Accessories
WARNING

l Use only the accessories specified in this chapter. Using other accessories may result in incorrect
measurement values or equipment failure.
l One-time attachments can only be used once, and repeated use may result in performance
degradation or cross-contamination.
l If the accessory package or accessory is found to be damaged, don’t use it.
l All accessories that come into contact with the human body meet the biocompatibility
requirements of ISO 10993-1.
l Dispose of discarded accessories in accordance with local regulations or the hospital's waste
disposal system. Do not discard them.

No. PN Model Type Description

ECG cable

1 040-000413-00 98ME01EB046 / 3-lead, IEC standard, cable

2 040-000492-00 98ME01AC658 Clip 3-lead, IEC standard, cable wire

Masimo SPO2 sensor

3 040-000361-00 M-LNCS YI Reusable Neonatal, foot, palm or wrist bundled type

4 040-000313-00 S-A1202026 Reusable Cable extender

5 049-000256-00 / / Masimo Y-type sheath

Nellcor SPO2 sensor

6 040-000075-00 D-YS Reusable Neonatal, foot, palm or wrist bundled type

7 040-000243-00 SLZ068 Reusable Cable extender
NIBP cuff

8 040-000593-00 U1881S Reusable NIBP cuff, Pediatric arm 18-26CM

9 040-000594-00 U1882S Reusable NIBP cuff, Infant arm 10-19CM

10 040-000595-00 U1883S Reusable NIBP cuff, Neonate arm 6-11CM

11 040-000743-00 U1681S Disposable NIBP cuff, Neonate arm 3-6CM

12 040-000744-00 U1682S Disposable NIBP cuff, Neonate arm 4-8CM

13 040-000745-00 U1683S Disposable NIBP cuff, Neonate arm 6-11CM

Page 20-1
14 040-000746-00 U1684S Disposable NIBP cuff, Neonate arm 7-13CM

15 040-000747-00 U1685S Disposable NIBP cuff, Neonate, 8-15CM

16 040-000934-00 98-0400-99 Disposable NIBP cuff, Neonate (3-6CM)

17 040-000935-00 98-0400-96 Disposable NIBP cuff, Neonate (4-8CM)

18 040-000936-00 98-0400-97 Disposable NIBP cuff, Neonate (6-11CM)

19 040-000937-00 98-0400-98 Disposable NIBP cuff, Neonate (7-13CM)

20 040-000938-00 98-0400-90 Disposable NIBP cuff, Neonate( 8-15CM)

CO2
Respironics CAPNOSTAT mainstream CO2
21 099-000005-00 1015928 Mainstream
module
22 099-000004-00 1022054 Sidestream Respironics LOFLO sidestream CO2 module

23 099-000006-00 200101 Mainstream PHASEIN(Masimo) IRMA CO2 module

24 099-000007-00 800101 Sidestream PHASEIN Masimo ISA CO2 module

TEMP probe

25 040-000846-00 CMTA3101 Reusable Neonate surface

Wake

26 040-000443-00 A0916-C05 Reusable Wake probe;9PIN connector/APK

Mattress

27 040-001071-00 PU Reusable Leather mattress

28 040-001078-00 KGP5110-22 Reusable Thermal gel mattress

Resuscitation accessories
European standard oxygen air hose (with
29 040-000848-00 / Reusable
British joint)
European standard Air air hose (with British
30 040-000849-00 / Reusable
joint)
31 040-001106-00 6002/VADI Disposable Neonatal mask (big)

32 040-001107-00 6001/VADI Disposable Neonatal mask (small)

VADI
33 040-001108-00 Disposable Connector
G-311063-1
34 040-001109-00 VADI_G-311905 Disposable PEEP valve

VADI_G-311003
35 040-001110-00 -4-1+V-12W060- Disposable Corrugated pipe joint objects
15+G-311050

Page 20-2
Note: 1. Annex, such as with a large mask of its dead space area of 35.3 ml, such as with a small face mask of
its dead space area of 19.5 ml.
2. The influence of the recommended appendages on the impedance under different working pressure is
asfollows.
Exhalation Inhalation
pressure
Impedance Impedance
280kPa 5.06hPa 5.25hPa
600kPa 4.38hPa 4.90hPa

Page 20-3
 Chapter 21 EMC
Warning
l The equipment or system shall not be used close to or stacked with other equipment.If it must be
used in close proximity to or stacked with other equipment, observe to verify whether it is able
to function properly in its intended configuration.
l Class A equipment is intended for use in industrial environments.Due to Infant Radiant Warmer’s
conducted emission and radiated emission, there may be potential difficulties in ensuring
electromagnetic compatibility in other environments.
l Use of accessories, transducers and cables other than those specified may lead to emission
increase or immunity decrease of the equipment or system, except for the transducers and
cablessold by the manufacturer of equipment or system as the spare parts for internal
components.
l It may lead to inaccurate consequences if the physiological parameters measured by the device are
less than the specified minimum (HR: 15bpm; BP: 40mmHg for NS, 10mmHg for ND; PR:
20bpm).

Note
l The Infant Radiant Warmer meets the relevant EMC requirements of IEC 60601-1-2(YY 0505).
l Users shall install and use according to the EMC information provided in the accompanying file.
l Portable and mobile RF communications equipment may affect Infant Radiant Warmer’s
properties. Therefore, avoid strong electromagnetic interference when in use, such as near mobile
phones, microwave ovens, etc.
l See the Annex for the detailed guidance and manufacturer’s declaration.

Essential performance

Unrecognized basic performance Manufacturer does not recognize the basic performance of EUT

1. Skin temperaturemeasurement accuracy ±0.1 ℃

2. Heart rate measurement accuracy±1% or ±1 bpm )Take the

bigger one
3. SpO2 saturation measurement accuracy±3 %
Basic performance
4. Pulse Rate(PR) measurement accuracy ±1bpm
5. NIBP measurement accuracy ±3 mmHg
6. EtCO2 measurement accuracy ±2mmHg
7. Suction pressure measurement accuracy±5%

Page 21-1
 8. PIP measurement accuracy ± 5cm H 2O
9. PEEP (Positive end expiratory pressure)
10. Continuous Positive pressure flow measurement accuracy ± 2
L/min
11. Blu-ray therapeutic instrument measuring intensity
Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS – for all MEEQUIPMENT and ME
SYSTEMS

declaration - electromagnetic emission

VAV-IW is intended for use in the electromagnetic environment specified below. The customer or the user
of VAV-IW should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
VAV-IW uses RF energy only for its internal
RF emissions function. Therefore, its RF emissions are very low
Group 1
CISPR 11 and are not likely to cause any interference in nearby
electronic equipment.
RF emissions VAV-IW is suitable for use in all establishments
Class A
CISPR 11 other than domestic and those directly connected to the
Harmonic emissions public low-voltage power supply network that supplies
Complies
IEC 61000-3-2 buildings used for domestic purposes.
Voltage fluctuations/
flicker emissions Complies
IEC 61000-3-3

declaration - electromagnetic immunity

VAV-IW is intended for use in the electromagnetic environment specified below. The customer or the user
of VAV-IW should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete or
discharge ±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 kV, ceramic tie. If floors are covered with
(ESD) ±15 kV air ±15 kV air synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30 %.

Page 21-2
Electrical fast ± 2 kV for power supply ± 2 kV for power
Mains power quality should be that
transient/burs lines supply lines
of a typical commercial or hospital
t IEC 61000-4- ± 1 kV for input/ output ± 1 kV for
environment.
4 lines input/output lines
100 kHz repetition 100 kHz repetition
frequency frequency

Page 21-3
Surge IEC ± 0.5kV, ± 1 kV line (s) ± 0.5kV, ± 1 kV
Mains power quality should be that
61000-4-5 to lines line(s) to lines
of a typical commercial or hospital
± 0.5kV, ± 1 kV, ± 2 kV ± 0.5kV, ± 1 kV, ± 2
environment.
line(s) to earth kV line(s) to earth
Voltage dips, *95% UT; 0.5 cycle At 0 % UT; 0.5 cycle
Mains power quality should be that
0°, 45°, 90°, 135°, 180°, At 0°, 45°, 90°,
short of a typical commercial or hospital
225°, 270°and 315° 135°, 180°, 225°,
interruption environment. If the user of the
270°and 315°
s
and voltage *95% UT; 1 cycle and VAV-IW requires continued
variations on 30% UT; 25/30 cycles 0 % UT; 1 cycle and operation during power mains
power supply Single phase: at 0° % UT;30
interruptions, it is recommended
25/30
input lines that the VAV-IW be powered from
> 95% UT; 250/300 cycles Single phase:
IEC an uninterruptible power supply
cycles at 0°
61000-4-11 or a
0 % UT; 250/300 battery.
cycles
Power 30 A/m(50/60 Hz) 30 A/m Power frequency magnetic fields
frequency should be at levels characteristic of a
magnetic field typical location in a typical
IEC 61000-4-8 commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

declaration - electromagnetic
immunity
VAV-IW is intended for use in the electromagnetic environment specified below. The customer or the user
of VAV-IW should assure that it is used in such an environment.
Immunity IEC 60601 test level Compliance Electromagnetic environment - guidance
test level
Conducted 3V 3V Portable and mobile RF communications equipment

RF 0.15 MHz to 80 0.15 MHz to 80 should be used no closer to any part of

IEC MHz MHz VAV-IW, than the recommended separation

61000-4-6 6 V in ISM and 6 V in ISM and distance calculated from the equation applicable to
between 0.15 MHz between 0.15 the frequency of the transmitter.
MHz Recommended separation distance

Page 21-4
Radiated 3V/m 3V/m 3.5
d P 150 KHz to 80 MHz
RF 80 MHz to 2.7 GHz
V 1
IEC 3.5
d P 80 MHz to 800 MHz
61000-4-3
E 1

7
d P 800 MHz to 2.7 GHz
E 1

where P is the maximum output power rating of the

transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as

a
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.

Interference may occur in the vicinity of equipment

marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed RF transmitters, such as base stations for radio (cellular/cordless)
telephonesand land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which VAV-IW is used exceeds the applicable RF compliance level above,
VAV-IW should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating VAV-IW.

Recommended separation distances between

portable and mobile RF communications equipment and VAV-IW

Page 21-5
VAV-IW is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of VAV-IW can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and VAV-IW, as recommended below, according to the maximum output power of the
communications equipment.

Page 21-6
Rated maximum Separation distance according to frequency of
transmitterm
outputpower of
0.15 MHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
transmitter W
d 1.2 P d 1.2 P d 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance din meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P isthe maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

declaration - IMMUNITY to proximity fields from RF wireless communications equipment

VAV-IW is intended for use in an electromagnetic environment in which RF wireless communications
equipment are controlled.
Immunity IEC60601 test level Compliance Electromagnetic
test Test Modulation Maximum Immunity level environment -

frequency power level guidance

Radiated 385 MHz **Pulse 1.8W 27 V/m 27 V/m

RF Modulation:
IEC 18Hz
61000-4-3 450 MHz *FM+ 5Hz 2W 28 V/m 28 V/m
deviation:
1kHz sine
710 MHz **Pulse 0.2 W 9 V/m 9 V/m
745 MHz Modulation:
780 MHz 217Hz
810 MHz **Pulse 2W 28 V/m 28 V/m
870 MHz Modulation:
930 MHz 18Hz
1720 MHz **Pulse 2W 28 V/m 28 V/m
1845 MHz Modulation:
1970 MHz 217Hz

Page 21-7
 2450 MHz **Pulse 2W 28 V/m 28 V/m
Modulation:
217Hz
5240 MHz **Pulse 0.2 W 9 V/m 9 V/m
5500 MHz Modulation:
5785 MHz 217Hz
Note * - As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it
does not represent actual modulation, it would be worst case.
Note** - The carrier shall be modulated using a 50 % duty cycle square wave signal.

Page 21-8
 Chapter 22 Specification Parameters
1. Classification
Name Type
Medical device classification (CFDA) Class III
CE classification IIb
Belonging to Class I, among which the ECG
detection part belongs to CF-type anti-
defibrillation applied part; the skin
Classification in accordance with the protection
temperature, NIBP and SPO2 detection parts
against electric shock
belong to BF-type anti-defibrillation applied
parts; RESP, PR/pulse and EtCO2 detection
parts belong to BF-type applied parts.
EMC classification Class A
Ordinary equipment (the equipment of
Degree of protection against the liquid whichthe shell has no protection against the
liquid,
IPX0, except C31 and Pedal are IPX1.)
Classification in accordance with the degree of
It cannot be used in the flammable anesthetic
safety at the time of use in flammable anesthetic
gas mixed with air or the flammable
gas mixed with air or flammable anesthetic
anesthetic gas mixed with oxygen or nitrous
gas
oxide
mixed with oxygen or nitrous oxide
Classification in accordance with the operating
Continuous operating equipment
mode
Whether there is a signal output or input section There are signal output and input sections
Permanent installation or non-permanent Infant Radiant Warmer is a non-permanent
installation installation

Page 22-1
 National standards:
GB/T 191, YY/T0316, YY 0455, YY/T
0466.1, YY 0505, YY0600.5, YY 0601, YY
0636.3, YY/T 0664, YY0667, YY0668, YY
0669/XG1, YY 0670, YY0671.2, YY/T 0708,
YY 0709, YY 0784, YY 0785, YY 0893, YY
Compliance with the relevant standards
1040.1, YY1079, GB4824, GB/T 6881.1, GB
9706.1, GB 9706.12, GB 9706.25, GB/T 9969,
SJ/T 11363, GB/T 14710, GB/T 16886.1,
GB/T 16886.5, GB/T 16886.10, GB/T21416
CE standards:
Directive 2011/65/EU, MDD 2007/47/EC,

Page 22-2
 ISO 780, EN 1041, EN 1060-1, EN 1060-3, EN
ISO 10993-1, EN ISO 10993-5, EN ISO 10993-
10, ISO 13485, EN ISO 14971, ISO
15223-1, IEC 60529, EN 60601-1, EN
60601-1-2, IEC 60601-1-6, IEC 60601-1-8,
IEC 60601-1-9, IEC 60601-2-21, IEC
60061-2-27, IEC 60601-2-49, IEC
60601-2-50, EN 62304, IEC 62366, IEC
80601-2-30, ISO 80601-2-61

2. Physical Parameters

Overall dimensions

Dimensions 1190mm(length)*640mm(width)*1800mm (height)

Net weight About 115 kg

Display specifications
Display 10.4-inch color touch screen
Display information See relevant sections in the Manual above
Battery specifications
Battery specifications 11.1V 4400mAh, rechargeable lithium-ion battery
Battery relative error +5%, -10%
Charging time is less than 12h when the device is powering on and less
Battery charging time
than 8h when powering off.
After fully charged, the battery can provide sustainable power supply
Battery operating time for1h (Excluding the heating function, phototherapy apparatus
treatment,
puncture lamp, bassinet tilt function and lifting function).

3. Environmental Specifications
Host
Temperature Atmospheric pressure
Item Humidity (non-condensing)
(ºC ) (kPa)
15%-80%(do not consider the case of
Operation 18°C -30℃ 70 kPa~106 kPa
compression)
Transportation 15%-80%(do not consider the case of
-20°C -60°C 50 kPa~106 kPa
and storage compression)

Page 22-3
4. Power Supplies Specifications
Power supplies specifications
Input voltage 100 -127 V~, 220 - 240 V~
Input frequency 50Hz/60Hz
8 A -9A(100 V~-127 V~)(VAV-I)
Input current
5.0 A -5.1A(220 V~ -240 V~)(VAV-IW)

Fuse T10AL/250V
Power cord 5m

5. Far-infrared radiation Heating (Radiant Warmer)

System
Infant mode and manual mode, along with the monitoring function and
Operating mode
resuscitation function.
Warm-up mode The product has the warm-up mode.
The maximum irradiance level at any point on the mattress shall not exceed
60 mW/cm2 in the total infrared spectrum.
Far-infrared
The maximum irradiance level shall not exceed 10 mW/cm2 in the
radiation range and
nearinfrared spectrum (760 nm to 1 400 nm).
irradiance
Meet the requirements of IEC 60601-2-21, 201.10.6 *Infrared radiation
requirements
(YY0455, Clause 33, Infrared radiation).
Accuracy of Less than 2°C.
distribution of Meet the requirements of IEC 60601-2-21, Subclause 201.12.1.102 –
irradiation to the Accuracy of distribution of irradiation to the mattress (YY0455, subclause
mattress 50.102).
a) Control range of skin temperature: 32°C~38.0°C;
Display increments: ±0.1°C
Control accuracy: ≤±0.5°C.

b) Display range of skin temperature: 25.0°C '45.0°C .

Control range and c"Display accuracy: ±0.1°C .

display range of skin 25.0'35.3 ±0.3
temperature d) skin temperature: 35.3'36.9 ±0.2
maximum permissible 37.0'39.0 ±0.1
error!unit&°C " 39.1'41.0 ±0.2

41.0'45.0 ±0.3
e) repeatability error S ≤0.2°C

Page 22-4
Spot intensity and The puncture lamp is divided into three levels:
radiation range of (a) High: 4500 Lux±500Lux ;

Page 22-5
puncture lamp (b) Medium:2500 Lux±500Lux ;
(c) Low: 1500 Lux±500Lux.
Spot size: 250mm±10%
a) Vertical shift: ±45°, with an error of ±3°in the center;
Rotation angle of b) Horizontal rotation: ±90°, every 45° for a level with an error of ±3° in
lamp holder the center;
c) Have the horizontal shift alarm and tilt alarm of the lamp holder.
Gesture audio paused Have the gesture audio paused function
Lifting platform’s lifting range: 0~200mm, with a lifting height error of
±4mm ; the weight that is withstood in any position is 3 times as much as
Bassinet
50Kg; lifting noise+60dB(A) (with a measurement distance of 3 m).
lifting(only VAV-IW)
Lifting motor’s operation cycle: Max.10%, max 2 min/18 min. (Work 2
minutes and rest 18 minutes, work efficiency is 10 %.)
a) Range of bassinet tilt angle: ±12°, with a tilt error of ±1 °.
b) Tilt to any position, and the bassinet bears a load of 10 kg.
c) Tilt noise+60 dB(A) (with a measurement distance of 3 m).
Bassinet tilt
d) The angle can be set rapidly.
e) Tilting motor’s operation cycle: Max. 25%, 2min/6min (Work 2
minutes and rest 6 minutes, work efficiency is 25 %.).
Load-bearing range
6Kg
of tray and bracket
Weighing range and a) Weight measuring range: 300g-8000g
accuracy b) Measurement accuracy: ±10g Display accuracy: 1g

6. Irradiation and Uniformity of the Phototherapy Apparatus

The phototherapyapparatus meets the requirements of IEC 60601-2-50 (YY 0669).
(1) High:
(a) Maximum:
in the band of 400nm-550nm: (3000±25% )μW/cm2 (phototherapy
intensity value within an effective band of 430nm-490nm:
(45±25 )%μW/cm2/nm)
The irradiation of the (b) Average:
phototherapy apparatus is in the band of 400nm-550nm:>2000uW/cm2(phototherapy intensity
divided into three levels: value within an effective band of 430nm-490nm: >30uw/cm2/nm)
(2) Medium:
(a) Maximum:
in the band of 400nm-550nm: 2000±25% μW/cm2(phototherapy
intensity value within an effective band of 430nm-490nm: !30±25% "
μW/cm2/nm)

Page 22-6
 (b) Average:
in the band of 400nm-550nm: >1200uW/cm2(phototherapy intensity
value within an effective band of 430nm-490nm: >20uw/cm2/nm)
(3) Low:
(a) Maximum:
in the band of 400nm-550nm:(1000±25% )μW/cm2(phototherapy
intensity value within an effective band of 430nm-490nm:
(15±25% )μW/cm2/nm)
(b) Average:
in the band of 400nm-550nm>700uW/cm2(phototherapy intensity
value within an effective band of 430nm-490nm: >10uw/cm2/nm)
Total bilirubin irradiance
uniformity in the
>0.4
effective radiation area
on the bassinet
Distribution area of the
effective surface of 50 cm *30cm
total
bilirubin irradiance
Phototherapyapparatus’s Total duration: 10,000 hours.
irradiation time records Single display duration: 99h 59min 59s.

7. ECG
Name Specifications
ECG requirements shall be in line with those of IEC 60601-2-27

Testing principle Using a circuit with large gain and strong anti-interference ability for
direct testing
Lead type 3-lead.
Three-lead RA, LA, LL, display lead: I, II, III
HR resolution 1bpm

Surgical mode: 1 Hz'20 Hz (-3.0dB'+0.4dB);

Frequency characteristics
Monitoring mode: 0.5 Hz'40 Hz (-3.0dB'+0.4dB);

Diagnostic mode: 0.05Hz'150 Hz (-3.0dB'+0.4dB);

Power frequency interference suppression: ≥20dB;
Power frequency notch Monitoring and surgical: shall support 50/60 Hz notch function;
Diagnostic mode: Support to manually set the 50/60 Hz trapper,
manualselection of strong / weak notch.

Page 22-7
Common-mode rejection Diagnostic mode: *90dB;
capability
Monitoring mode: *105dB;

Page 22-8
 Surgical mode: *105dB
Differential-input ≥5MΩ.
impedance
Input signal range ±8 mV (peak-to-peak).
HR detection level trigger HR detection triggers the threshold level of 200μV.
threshold
According to the requirements of 4.1.2.1 c) in IEC 60601-2-27(YY
High T wave suppression
1079), the heart rate meter can effectively suppress the high T wave
of
1.2 mV.
Input dynamic range DC bias voltage can be up to ± 750mV.
ECG self-learning Able to manually actuate ECG self-learning.
function
Lead-off detection current Measuring electrode:+0.1μA

System noise The noise level equivalent to the input end shall be no greater
than
25μV (peak-to-peak).
Calibration voltage 1 mV, with an error range of ±5% .

Intelligent When a lead falls off, depending on the status of lead detachment,

lea ifthere are other leads available to calculate the heart rate, reselect

ddetachment the
lead for calculation and analysis.
HR measuring range and Range:15bpm'350bpm for neonates / Pediatrics
accuracy Accuracy: ±1bpm or ±1% , whichever is greater.
Electric knife According to the test method in Section 5.2.8.14 of IEC

noise 60601-2-27(YY1079), sse standard ECG lead wires; peak-to-peak noise

suppression shall be less than or equal to2mV relative to the ECG baseline.

Input signal reproduction Determine the total system error and frequency response according
to
accuracy
the Methods A and B used in IEC 60601-2-27(YY1079).
Input bias current According to the requirements of 3.1.5 in JJG760, the input circuit
current shall not exceed 0.1uA.

Post-defibrillation According to the requirements of 51.101.1in IEC 60601-2-27

baseline recovery (GB9706.25), the baseline recovery time after defibrillation shall be

time less than 5s.

Page 22-9
 According to the requirements of 191 in IEC 60601-2-27(GB9706.1),
Patient leakage current
the normal operating condition and single fault condition of
patient
leakage current shall be less than or equal to 100uA and 500uA.
Electric knife protection According to the requirements of4.2.8.14 in IEC 60601-2-27(YY1079),
the recovery time shall be less than 10s.

Scanning speed 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s, with an error of not

greater
than ±10% .

Page 22-10
 a) At least support 1.25mm/mV (×0.125) , 2.5 mm/mV (×0.25) , 5
Sensitivity gain and error mm/mV (×0.5) , 10 mm/mV (×1) , 20 mm/mV (×2) , 40 mm/mV (×4) and
automatic gain, with an error of less than ±5%.
b) Apply ±750mV DC polarization voltage, with a sensitivity range of
±5% .

Heart rate algorithm

Giant T wave When tested according to Clause 201.12.1.101.17 of IEC 60601-2-27, the
rejection heart rate meter can effectively reject the giant T wave of 1.2 mV.

Calculate the heart rate average by the following method according to the

Heart rate average requirements of Clause 201.7.9.2.9.101 b) 3) of IEC 60601-2-27: If the last
three consecutive RR intervals are over 1200 ms, the four latest RR intervals
are averaged to calculate the heart rate; otherwise, take 12 latest RR
intervals, maximum and minimum deceleration values, and then take the
average to calculate the heart rate.

According to the requirements of Clause 201.7.9.2.9.101 b) 4) of IEC

Heart rate meter
60601-2-27, the heart rate values displayed are:
accuracy
A1 (Bigeminy) 80 ± 1 bpm;
an
A2 (slow-change Bigeminy) 60 ± 1 bpm;
d arrhythmia
A3 (fast change Bigeminy) 120 ± 1 bpm;
response
A4 (bidirectional contraction) 90 ± 2 bpm.

Heart rate change According to the requirements of Clause 201.7.9.2.9.101 b) 5) of IEC 60601-

response time 2-27, the heart rate increases from 80 to 120 bpm: less than 10s; the heart
rate increases from 80 to 40 bpm: less than 10s.

According to the requirements of Clause 201.7.9.2.9.101 b) 6) of IEC

60601-2-27, the waveforms:
Start time of
B1 1-range: 10s;
tachycardia alarm
B1 0.5-range: 10s;
B1 2-range: 10s;
B2 1-range: 10s;
B2 0.5-range: 10s;
B2 2-range: 10 s.

8. NIBP
Name Specifications
NIBP requirements shall be in line with those of ISO 81060-2.
Method of measurement Vibration method

Page 22-11
Measured parameter NS, ND, NM
Operating mode Manual, automatic (cycle) mode
Cycle time of automatic
!1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 180, 240, 480"min
measurement
Unit mmHg, kPa
Maximum measuring Pediatrics: 120s; neonates: 85s.
period
Pediatric measurement range:
(a) 40mmHg '200mmHg(5.3kPa '26.7kPa) for NS;
Measurement range
(b) 20mmHg '165mmHg(2.7kPa '22kPa) for NM;

(c) 10mmHg '150mmHg(1.3kPa '20kPa) for ND.

Neonatal measurement range:
(d) 40mmHg'135mmHg(5.3kPa'18kPa) for NS;

(e) 20mmHg'110mmHg(2.7kPa'14.7kPa) for NM;

(f) 10mmHg'100mmHg(1.3kPa'13.3kPa) for ND.

Static Pediatrics: 0 mmHg(0 kPa) ' 300 mmHg(0kPa ' 40.0kPa),±3

measuremen mmHg(±0.4 kPa)

t pressure range and Neonates: 0 mmHg(0 kPa) ' 150 mmHg(0kPa ' 20.0kPa),±3
accuracy mmHg(±0.4 kPa)

Page 22-12
 Pediatric alarm preset range:
1) NS: 40mmHg~200mmHg
Upper limit: 42mmHg~200mmHg(5.6kPa~26.6kPa);
Lower limit: 40mmHg~198mmHg(5.3kPa~26.3kPa);
2) NM: 20mmHg~165mmHg
Alarm preset range and Upper limit: 22mmHg~165mmHg(2.9kPa~22kPa);
resolution Lower limit: 20mmHg~163mmHg(2.6kPa~21.7kPa);
3) ND: 10 mmHg~150mmHg
Upper limit: 12mmHg~150mmHg(1.6kPa~20kPa);
Lower limit: 10 mmHg~148mmHg (1.3kPa~19.7kPa).
Neonatal alarm preset range:
1) NS: 40mmHg~135mmHg
Upper limit: 42mmHg~135mmHg(5.6kPa~18kPa);
Lower limit: 40mmHg~133mmHg(5.3kPa~17.7kPa);
2) NM: 20 mmHg~110mmHg
Upper limit: 22mmHg~110mmHg(2.9kPa~14.7kPa);
Lower limit: 20 mmHg~108mmHg(2.6kPa~14.4kPa);
3) ND: 10 mmHg~100mmHg
Upper limit: 12 mmHg~100mmHg(1.6kPa~13.3kPa);
Lower limit: 10 mmHg~98mmHg (1.3kPa~13.1kPa).

Page 22-13
 Resolution: 1mmHg or 0.1kPa, whichever is greater.
Initial inflation pressure Pediatrics: 80 mmHg'200 mmHg;
setup range (mmHg)
Neonates: 60 mmHg'120 mmHg.

Auxiliary venipuncture Users can inflate with a NIBP cuff to form a pressure near ND, block
the veins, and assist with venipuncture.
Software overvoltage Pediatrics: 240 mmHg±3mmHg ;
protection Neonates: 147 mmHg±3mmHg .

Cuff pressure Pediatrics: 0 mmHg'240 mmHg

Neonates: 0 mmHg'147 mmHg

9. Resuscitation Properties
Resuscitation properties requirements shall be in line with ISO 10651-5, ISO 10079-3, and
ISO11195.
Oxygen and air
280 kPa'600kPa
supply pressure
Vacuum
Pressure measurement range: 0 kPa'
pressur
250*100kPaMeasurement accuracy: ± 2.5% full
egauge
scale
specifications
Sputum
a) Sputum suction pressure: -150mmHg'0 mmHgAccuracy: ±5%
suctio
b) In the case of maximum suction pressure, sputum suction flow: +20 L/min
npressure and
flow
range
Vacuum Pressure measurement range: -180 mmHg ~ 0
pressur mmHgMeasurement accuracy: ± 5% full scale(±9
egauge mmHg)
specifications
Oxygen
concentration Oxygen concentration range: 21% ~ 100% Accuracy: ± 3%

range
an
d
accuracy

Page 22-14
 a)Oxygen therapy range: 0 L/min'15 L/min
Flow range and
accuracy of b)Accuracy: 0 L/min'5 L/min(including 5 L/min)

oxygen therapy Accuracy range: ±0.5 L/min;

The accuracy range is ±1.5 L/min at 5 L/min ~ 10 L/min (including 10 L/min);The
accuracy range is ±2L/min at 10 L/min ~ 15 L/min (including 15 L/min).
(1) Continuous positive pressure flow range and accuracy
Resuscitationflow
(a) Flow range: 0 L/min'15 L/min
and pressure
(b) Accuracy:
The accuracy range is ±0.5 L/min at 0 L/min~5 L/min (including 5 L/min); The
accuracy range is ±1.5 L/min at 5 L/min ~ 10 L/min (in cluding 10 L/min);

Page 22-15
 The accuracy range is ±2L/min at 10 L/min ~ 15 L/min (including 15 L/min).
(2) Airway pressure gauge specifications
(a) Pressure measurement range: -20 cmH20'100cmH20
(b) Measurement accuracy: ±5% full scale
(3) PIP
(a) Maximum PIP:45 cmH2O±5cmH2O
(b) PIPvalues for misoperation:>30±4 cmH2O (Flow rate:15 L/min)
(4) PEEP
PIP≤30 cmH2O

a) !0'10"cmH2O
5 L/min&

b) !0'21"cmH2O
8 L/min&

c) !0'22"cmH2O
10 L/min&

d) !0'24"cmH2O
15 L/min&

30 cmH2O+PIP≤45 cmH2O

e) !0'10"cmH2O
5 L/min&

f) !0'24"cmH2O
8 L/min&

g) !0'34"cmH2O
10 L/min&

h) !0'35"cmH2O
15 L/min&
There is a buzzer in the air-oxygen mixer. When the pressure difference
Mechanical alarm
between oxygen and air is above 140kPa ± 20kPa or if one of the two
gasesbreaks down, it will be prompted.
Machine working time in 8L and 10L gas cylinder gas source:
@5L/min&, 158min
8L gas cylinder gas source,
@8L/min&, 131min
about the working hours
60% oxygen
@10L/min&, 118min
concentration
@15L/min&, 94min

@5L/min&, 198min
10L gas cylinder gas source, the
@8L/min&, 165min
approximate working hours
@10L/min&, 150min

@15L/min&, 118min
10. SPO2
Name Specifications
SPO2 requirements shall be in line with those of ISO 80601-2-61
Display Pulse waveform, SPO2

Page 22-16
Measuring principle Dual wavelength pulsation
SPO2 display resolution 1%

Page 22-17
 a) Masimo SPO2 measurement range is 1% to 100%; in the range of
70% to 100%, pediatric measurement accuracy is ± 2% (non-
SPO2 measurement exercise), ± 3% (exercise), and ± 3% for neonates (non-exercise and
rangeand accuracy exercise); in the range of 1% to 69%, the measurement accuracy is
not defined.
b) Nellcor SPO2 measurement range is 0% to 100%; in the range of
70% to 100%, pediatric measurement accuracy is ± 2% (non -exercise),
and ± 3% for neonates (non-exercise); in the range of 1% to 69%,
the
measurement accuracy is not defined.
Perfusion index (PI) Masimo SPO2 range: 0.02%'20%,the accuracy is not defined.
measurement range and
accuracy

Perfusion index(PI) Masimo SPO2: 0.02%'9.99%:

resolution 0.01%;
10.0%'20.0%: 0.1%.
Masimo SPO2:

Alarm preset limit and upper alarm limit: 1%'100% (lower limit+1%)'100%, lower alarm

resolution limit: 1%'(upper limit-1%);

Nellcor SPO2:
upper alarm limit: 20%'100% (lower limit+1%)'100%, lower alarm

limit:20%'(upper limit-1%);

Alarm accuracy error shall be ±1% of the set value.

Set the same-side If NIBP and SPO2 are measured on the same side of the arm, you can
measurement of NIBP turn on the NIBP ipsilateral switch. SPO2 physiological alarm status
and SPO2 does not change during NIBP measurements.
SIQ indication function Masimo SPO2 shall have the SIQ indication function.

11. PR Specifications
Name Specifications

Page 22-18
 (1) Masimo SPO2 module

The measurement range shall be 25bpm ' 240bpm; With a

Detection
resolution of 1bpm. The measurement error shall be ± 3bpm (non -
range
exercise status)and ± 5bpm (exercise status).
,resolution and error
(2) Nellcor SPO2 module

The measurement range shall be 20bpm ' 300bpm; With a

resolution of 1bpm. 20bpm ' 250bpm: The measurement error shall

be
±3bpm ,251bpm'300bpm: Themeasurement accuracy is not defined.
(3) NIBP module

Page 22-19
 The measurement range shall be 40bpm'240bpm; With a
resolution
of 1 bpm. The measurement error shall be ± 3bpm or ± 3%,
whicheveris greater.
a) Masimo SPO2 module
PR alarm range: 25bpm ~240bpm;upper alarmlimit: lower limit
+1bpm'240bpm;lower alarm limit: 25bpm'upper limit -1bpm;
b) Nellcor SPO2 module
PR alarm preset limit and
PR alarm range: 20bpm ' 300bpm;upper alarmlimit: lower
resolution limit+1bpm'300bpm; lower alarm limit:20bpm'upper limit-1bpm;
c) NIBP module
PR alarm range: 40bpm~240bmp; upper alarmlimit:lower limit
+1bpm'240bpm; lower alarm limit: 40bpm'upper limit-1bpm;
d) Alarm resolution: ±1bpm.

12. EtCO2 Specifications

Name Specifications
EtCO2 moduleshall meet the requirements of ISO 80601-2-55-2011.
Display CO2 waveform, CO2 value
Measuring method Infrared absorption method
EtCO2 detection Infant Radiant Warmershall support the following kinds of CO2
modules:
Respironics mainstream, sidestream CO2 measurement;
MasimoTM mainstream, IRMATM sidestream CO2 measurement.
Respironics CO2 Respironics mainstream:
measurement range and CO2 measurement range:
accuracy 0mmHg ' 150mmHg, 0% ' 19.7%, 0kPa ' 20kPa

(at760mmHg).
CO2 accuracy:
a) ±2mmHg at 0mmHg'40mmHg;

b) ±5% *displayed values at 41mmHg'70mmHg;

c) ±8% *displayed values at 71mmHg'100mmHg;

d) ±10% *displayed values at 101mmHg'150mmHg.

awRR measurement range:

2rpm'150rpm.
awRR measurement accuracy:
±1rpm .

Page 22-20
Respironics sidestream:
CO2 measurement range:

Page 22-21
 0mmHg ' 150mmHg, 0% ' 19.7%, 0kPa '
20kPa(at760mmHg).
CO2 accuracy:
a) ±2mmHg at 0 mmHg '40mmHg;

b) ±5%× readingat 41 mmHg '70mmHg;

c) ±8%×readingat 71mmHg '100mmHg;

d) ±10%×readi ngat 101mmHg'150mmHg.

awRR measurement range: 2rpm'

150rpm.
awRR measurement accuracy:
±1rpm .
Masimo CO2 Masimo mainstream:
measurement range and CO2 measurement range: 0mmHg'190mmHg,
accuracy
0%'25% (at 760mmHg).CO2 accuracy (all

conditions):
± ( 2.25mmHg+4% of the reading).
awRR measurement range:

0rpm'150rpm.

awRR measurement accuracy:

±1rpm .
Masimo sidestream:

CO2 measurement range: 0mmHg'

190mmHg, 0'25%(at760mmHg).CO2

accuracy (all conditions):

± (2.25mmHg +4% of the reading).
awRR measurement range:

0rpm'150rpm.

awRR measurement accuracy:

±1rpm .

Page 22-22
CO2 alarm range (a) Respironics CO2
andalarm (1) Alarm range: mainstream, sidestream: 0 mmHg ~150 mmHg.
error (2) Upper alarm limit: !Lower limit+2mmHg"~150mmHg,

lower alarm limit: 0mmHg~!upper limit-2mmHg". Alarm

error: ±0.1kPa or ±1mmHg.

(3) AWRR upper alarm limit: !Lower limit+2 rpm" ~150 rpm,

Lower alarm limit: 0mmHg~!upper limit-2 rpm". Alarm

error: ±0.1rpm.

(4) inCO2 upper alarm limit: ! Lower limit +1mmHg "

~76mmHg, lower alarm limit: 0mmHg~ ! upper limit

Page 22-23
 -2mmHg".

(b) Masimo CO2

(1) Alarm range: mainstream, sidestream: 0 mmHg ~190 mmHg.
(2) Upper alarm limit: Lower limit+2mmHg~190mmHg, lower
alarm limit: 0mmHg~upper limit-2mmHg. Alarm error:
±0.1kPa or ±1mmHg.

(3) AWRR upper alarm limit: !Lower limit+2 rpm" ~150 rpm,

Lower alarm limit: 0mmHg~!upper limit-2 rpm". Alarm

error: ±0.1rpm.

(4) inCO2 upper alarm limit: ! Lower limit+2 mmHg "

~99mmHg, lower alarm limit: 0mmHg~ ! upper limit

-2mmHg".

13. MASIMO CO2 Analyzer Specifications

Name Specifications
ISAsidestream gas analyzer specifications
Measuring method Infrared gas measurement
Apnea alarm time 10s, 15s, 20s, 25s, 30s, 35s, 40s
General specifications
Subminiature low-flow sidestream gas analyzer with integrated
Description
micro-pump, zero-return valve and flow controller.
Operating temperature ISA CO2: 0℃ to 50℃(32 ℉ to 122 ℉)
Storage temperature ISA CO2: -40℃to 700℃(-40℉to 158℉)
Operating humidity ISA CO2: < 4kPa H2O(non-condensing)(95% RH)30℃)
Storage humidity ISA CO2: 5% -100% RH(non-condensing)(100% RH)40℃)
Atmospheric pressure for 52.5 kPa to 120kPa (maximum altitude corresponding to 4572
operation m/15000 feet)
Atmospheric pressure for 20 kPa to 120kPa (maximum altitude corresponding to 11760 m/38600
storage feet)
4.5 V -5 V V DC ISA CO2 :<1.4W (normal operation),<1.8W (peak
Power supply
@5V DC)
Water treatment The sampling tube uses a patented waterproof tube
Sampling flow rate 50 10ml/min
Data output
CO2, O2, N2O, anesthetic gases (halothane, enflurane, isoflurane,
Fi/ET value
sevoflurane, desflurane)

Page 22-24
 Four gas concentration waveforms can be displayed simultaneously at
Waveform
most.

Page 22-25
Diagnostic parameters Atmospheric pressure
Respiration detected, no respiration detected, oxygen
Mark sensorreplacement, sampling tube inspection,
unspecified accuracy and
sensor error
Gas analyzer
2-channel to 9-channel NDIR gas analyzer, with a
ISA probe
measurement range of 4μm to 10μm
ISA CO2: Automatic pressure and temperature compensation.
Compensation
Compensate for the broadening effect of CO2
No calibration required. Zeroing is performed automatically at each
Calibration
start, followed by auto-zeroing every 24 hours (ISACO2)
Preheat time ISA CO2: < 10s
Gas
The accuracy of all measured values complies with the requirements of
Measuring range and
EN ISO 21647: 2004 and EN 864: 1996.
accuracy for standard
CO2 range: (0-15 )vol% Accuracy: 2% of reading
conditions:
CO2 range: (15-25)vol% Accuracy: unspecified
Accuracy specifications (0.3 vol%+4% of the reading)
in all conditions
Rise time CO2≤250ms
Total system response < 3s(2m sampling tube)
time
Adaptive threshold, with a minimum CO2 concentration change of
Respiration detection
1vol%
Respiratory rate (0-150) respirations / min

Effects of the interfering gases and steam

Gas or steam Gas CO2 Anesthetic Nitrous
concentratio ISA CO2 ISA AX+ gas oxide
n

Nitrous oxide 4) 60 vol% _2) _1) _1) _1)

HAL4) 4 vol% _1) _1) _1) _1)
Enflurane, isoflurane, 5 vol% +8% of the _1) _1) _1)
sevoflurane 4) reading3)
Desflurane 4) 15 vol% Reading+12% _1) _1) _1)
3)

Page 22-26
Xe4) 80 vol% Reading-10%3) _1) _1)

Page 22-27
He4) 50 vol% -6% of the reading3) _1) _1)
Quantitative spray Quantitative spray
C2H50H4) 0.3 VOI% _1) _1) _1) _1)
C3H70H4) 0.5 VOI% _1) _1) _1) _1)
4)
CH3COCH3 1 vol% _1) _1) _1) _1)
4)
CH4 3 vol% _1) _1) _1) _1)
CO5) 1 vol% _1) _1) _1) _1)
NO5) 0.02 vol% _1) _1) _1) _1)
5)
O2 100 vol% _2) _2) _2) _2)
Note 1: The "Accuracy - All conditions" specifications above contain negligible interference and
effects.
Note 2: The "Accuracy - All conditions" specifications above contain negligible interference and
effects when properly setup the nitrous oxide / oxygen concentration.
Note 3: Interference at indicated gas concentrations. For example, 50 vol% helium usually
results in a 6% drop in carbon dioxide readings. That is, if a mixed gas containing 5.0 vol%
carbon dioxide and 50 vol% nitrogen is measured, the actually measured carbon dioxide
concentration is usually (1-0.06) * 5.0 vol% = 4.7 vol% carbon dioxide.
Note 4: Complywith EN ISO 21647 standard.
Note 5: Supplement EN ISO 21647 standard.

Effects of the interfering gases and steam

Gas CO2 Anesthetic Nitrous
Gas or steam
concentration ISACO2 ISA AX+ gas oxide
1&2) 1&2) 1)
Nitrous oxide 4)
60 vol% _ _ _ _1)
Hyaluronan 4) 4 vol% _1) _1) _1) _1)
Enflurane, isoflurane, 5 vol% +8% of the _1) _1) _1)
sevoflurane 4) reading3)
15 vol% Reading+12% _1) _1) _1)
Desflurane 4) 3)

Xe4) 80 vol% Reading-10%3) _1) _1)

He4) 50 vol% -6% of the reading 3) _1) _1)
Quantitative spray 4) Not for quantitative spray
C2H50H4) 0.3 VOI% _1) _1) _1) _1)
C3H70H4) 0.5 VOI% _1) _1) _1) _1)
4) 1 vol% _1) _1) _1) _1)
CH3COCH 3

4)
CH4 3 vol% _1) _1) _1) _1)

Page 22-28
CO5) 1 vol% _1) _1) _1) _1)
NO5) 0.02 vol% _1) _1) _1) _1)
O2 5) 100 vol% _1&2) _1&2) _1) _1)
Note 1: The "Accuracy - All conditions" specifications above contain negligible interference and
effects.
Note 2: For probes that do not measure nitrous oxide and / or oxygen, set the concentration
(SetN2O/ SetO2) as described in Section 4.2. See also Annex B. (IRMA CO2 does not measure
nitrous oxide or oxygen.) IRMA AX + does not measure oxygen.)
Note 3: Interference at indicated gas concentrations. For example, 50 vol% helium usually
results in a 6% drop in carbon dioxide readings. That is, if a mixed gas containing 5.0 vol% carbon
dioxide and 50 vol% nitrogen is measured, the actually measured carbon dioxide concentration is
usually: (1-0.06) * 5.0 vol% = 4.7 vol% carbon dioxide.
Note 4: Complywith EN ISO 21647 standard.
Note 5: Supplement EN ISO 21647 standard.
14. RESP Measurement

RESP display Digital display of the respiratory waveform and

respiratory rate

Lead measurement Optional leads I and II, the default is the II lead,
you can choose automatic lead.
Respiratory excitation waveform <300μA RMS,64kHz(±10 -).
a) Measuring range: 0rpm ~ 150rpm for
Respiratory rate detection neonatesor Pediatrics;
b) Measurement accuracy: 0rpm ~ 6rpm: no
definition; 7rpm ~ 150rpm: ± 2rpm or 2%,
whichever is greater.
a) Neonatal / pediatric alarm preset limit: 0rpm
Respiration rate alarm preset accuracy
~150rpm;
b) Alarm resolution:1rpm.
No breathing alarm Pediatric, neonatal setup range: 10s ~ 40s;
measurement error shall be ± 5s.
Infant Radiant Warmer shall be able to alert
Cardiac interference recognition function
youwhen heart rate and
respiration rates are
consistent.
It shall have neonatal apnea detection and apnea awakening functions
15. Alarm System
Name Specifications
The alarm system meets the requirements of IEC 60601-1-8

Page 22-29
Alarm volume range 77dB (back 1m)~50dB (front 3m)

Page 22-30
16. Other Functions
Recording paper width: 50mm, effective
recording width: 48mm, paper feeding
speed: 25mm / s, 50mm / s, real-time
Print record
recording time can be set to: 3s, 5s, 8s,
connection, polysomnographical waveform:
2 channels,
alarm trigger record: yes.
a) Apgar timer range: 00: 00-59: 59
b) Divided into two modes: counting and
countdown, and 10 alarm time nodes can be
Apgar timer function set
c) Display accuracy 1s
d) Resolution: 1s
e) Alarm time: 3s
Waveform holographic reviews of less than
24 minutes can be saved and replayed (the
Waveform storage time
specific time is related to the number of
waveforms and waveforms stored).
There shall be a screen real-time waveform
Wave freezing function
freezing function.
a) There shall be the observation function
oftrend graphs.
b) There shall be the observation function
Trend observation function oftrend charts.
c) It shall be able to store the data of the
trendgraph / trend chartof 72 hours for
each
operating parameter.
It shall havea password-protected demo
Demo function
function interface.

Page 22-31
 a) It shall have the function of three alarm
modes, such as sound alarm, light alarm and
text description;
b) It shall have the function of automatic

alarm record printing;

A variety of alarm selections and alarm functions
c) It shall have the function of alarm safety
warning function;
d) When an alarm occurs, it shall have the
alarm function. Press the audio paused
button on the panel. Press again to restore
the

Page 22-32
 alarm sound.
a) It shall have the functions of module
activation and deactivation;
Display interface functions
b) The waveform and parameter colors shall
be able to be regulated randomly.
It shall have the function of system software
Free disassemble software site upgrade function
upgrade without disassembling.
Product has three-CPU control system
Three-CPU control system
protection function.
360°alarm display Product has the 360°alarm display function.
X-ray film cassette is equipped under the
X-ray film cassette under the Pediatric bassinet
infant bassinet
Product is equipped with a storage box with
Storage box with pull-out drawer
pull-out drawer
Product havethe three-layer
Three-layer overheating protection overheatingprotection of
software, hardware and
mechanical engineering.
Product has a door damping protection
Door opening damping
function.
Product has a temperature correction
Temperature correction function
function.
Caster Casters have the foot brake function.
Infant Radiant Warmer can be connected
Netwoking function withother display terminals
through setup
protocols.

Page 22-33
17. Schematic Diagram

Figure 22-1 Schematic diagram of gas path

Serial
Description Serial number Description
number

oxygen pressure
1 15
source(280- reducer

600kPa) (0.125MPA)

pressure
2 air source (280-600kPa) 16
reducer

(0.08MPA)

3 Filter 17 Air resistance-L

PIP control valve

4 relief valve (0.78MPA) 18
(0-5.5kPa)

5 check valve 19 PIP valve

6 negative pressure switch 20 air resistance

Page 22-34
 Pressure PIP control valve
7 21
reducer (0-4.5Kpa)

(0.26MPA)

Page 22-35
8 pressure regulator valve 22 membrane safety valve

recovery flow control

9 vacuum generator 23
valve

negative pressure oxygen therapy flow

10 24
safetyvalve control valve

11 negative pressure gauge 25 airway pressure gauge

12 negative pressure 26 recovery joint

connector
13 medical gas switch 27 oxygen therapy joints

14 empty oxygen mixer

Page 22-36
 Figure 22-2 Schematic diagram of pneumatic system

NO. NAME NO. NAME

1 Air inlet components 13 PIP flow meter

2 Negative pressure system switch 14 Air resistance

3 Pressure reducing valve system 15 Film safety valve assembly

Negative pressure system

4 16 Exhaust throttle
flowmeter

Vacuum generator and safety valve

5 17 Airway pressure gauge
assembly

Negative pressure gauge

6 18 Recovery connector
andNegative pressure
connector

7 Medical gas switch 19 Oxygen therapy connector

8 Empty oxygen mixer 20 Bellows assembly

9 Pressure reducer 21 Connector
10 PIP valve 22 PEEP valve
11 Resuscitation flow meter 23 Mask
12 Oxygen flow meter

Page 22-37
Tende Elektronik ve Yazılım Ltd. Şti has declared and confirmed the device’s conformity to 93/42 EEC Medical
Devices Directives of Community Europe Directives in the case that device is used in accordance with the
instruction in the “User and Maintenance Guide”.

Second symbol impels that electrical and electronic equipment not to be thrown like uncategorized state waste
and to be collected separately. Please contact to authorized representatives for the information concerning
service take off.