NOXtec:

User manual for:

NOXtec 1000
NOXtec 2000
NOXtec 3000

Document reference: 01NXTC1000MU

Ingeniería y Técnicas Clínicas, S.A.

c/ Tungsteno 11-15
Rev. 20En – 10/2019 E-28500 Arganda del Rey (Madrid) SPAIN
Tel +34 918 719 950
[Link] itcsal@[Link]
 NOXTEC: USER MANUAL

Rev. 20En – 10/2019 2

 NOXTEC: USER MANUAL

Contents
1. User responsibilities ........................................................................................................................................... 6

2. Symbols .................................................................................................................................................................... 7

3. Safety warnings .................................................................................................................................................... 8

4. Definitions and abbreviations ......................................................................................................................... 9

5. Introduction to this manual .......................................................................................................................... 11

6. General description of the device .............................................................................................................. 12

6.1. Intended use.............................................................................................................................................. 13

6.2. Operating principle ................................................................................................................................. 14

7. Unpackaging the device ................................................................................................................................. 17

8. Parts and accessories ................................................................................................................................... 18

8.1. NO and NO2 absorbents..................................................................................................................... 20

9. Connecting the device..................................................................................................................................... 21

10. Initial checks ................................................................................................................................................... 27

10.1. Before turning on............................................................................................................................... 27

10.2. Initial automatic system verification .......................................................................................... 27

11. Operational dosing modes (ONLY for NOXtec 1000) ................................................................ 29

11.1. Real time ................................................................................................................................................ 29

11.2. Automatic .............................................................................................................................................. 29

11.3. Semi-automatic ................................................................................................................................... 29

11.4. Manual .................................................................................................................................................... 30

11.4.1. Emergency mode..................................................................................................................... 30

12. Respiratory flow sensor (ONLY for NOXtec 1000) ..................................................................... 34

13. General user interface .............................................................................................................................. 35

13.1. Control button ..................................................................................................................................... 35

13.2. Patient identification ......................................................................................................................... 36

Rev. 20En – 10/2019 3

 NOXTEC: USER MANUAL

13.3. Main screen ......................................................................................................................................... 37

13.4. Checks before start dosing ........................................................................................................... 37

13.5. Dose start (ONLY for NOXtec 1000) ...................................................................................... 39

13.6. Locking the User Interface ............................................................................................................ 41

13.7. Muting the audible alarms............................................................................................................. 42

13.8. Settings .................................................................................................................................................. 43

13.8.1. Calibrate options ...................................................................................................................... 43

13.8.2. Monitoring options .................................................................................................................. 44

13.8.3. Dosing options (ONLY for NOXtec 1000).................................................................... 45

13.8.4. Advanced settings (ONLY for NOXtec 1000 and partially for NOXtec 2000)
47

13.9. Showing the treatment data and log and downloading save studies ........................ 48

13.10. Turning off the device....................................................................................................................... 49

13.11. Help .......................................................................................................................................................... 50

14. Cylinder exchange (only available for authorized users and version NOXtec 1000) ... 51

15. Monitor calibration (only available for authorized users) .......................................................... 55

15.1. Automatic calibration of gases sensors ................................................................................. 55

15.2. Verification of the calibration ....................................................................................................... 57

16. Alarms............................................................................................................................................................... 58

16.1. Alarm system verification .............................................................................................................. 61

17. Training courses required for the use of NOXtec ........................................................................ 62

18. Warranty ......................................................................................................................................................... 63

19. Cleaning ............................................................................................................................................................ 64

20. Technical specifications ............................................................................................................................ 65

20.1. Physical specifications ..................................................................................................................... 65

20.2. Operating and storage conditions ............................................................................................. 65

20.3. Monitoring module ............................................................................................................................ 65

20.4. Dosing module and User Interface (only for NOXtec 1000 and 2000) .................. 66

Rev. 20En – 10/2019 4

 NOXTEC: USER MANUAL

20.5. Electrical specifications................................................................................................................... 66

20.6. Electromagnetic and RF specifications ................................................................................... 67

21. Troubleshooting ............................................................................................................................................ 71

22. Control of the NO2 concentration ......................................................................................................... 73

23. Compatibility with ventilators .................................................................................................................. 74

Rev. 20En – 10/2019 5

 NOXTEC: USER MANUAL

1. User responsibilities
NOXtec will operate in accordance with the information contained in this User Manual, the
device label and other documents that could be attached to the device. The device must be
set up, operated, maintained and repaired in accordance with the instructions provided by
the manufacturer.

NOXtec should be ONLY used in accordance with the Intended Use contained in this manual
(section 6.1). Do not use this unit for other purposes not specified by the manufacturer.

NOXtec should be checked periodically by qualified personnel. If the device is defective, broken
or with mechanical deformations, turn it off and do not use it for clinical activities.

Do not use disposable different to those recommended by the manufacturer. If any part of
the device, or a disposable, is damaged, contaminated or defective, replace it immediately.

Should the device need to be repaired or replaced, it must be reported to the technical
service and be repaired only by qualified personnel authorized by ITC, S.A.

Check regional legislation or restrictions that must be applied to the sale or use of this
device. Use only NO mixed cylinders approved for medical use and handle and store them in
accordance with the regulations in force in your country.

Users of this product are responsible for any malfunction resulting from improper use,
defective maintenance, improper repair, damage or alteration by any person or entity other
than ITC, S.A. or authorized by this manufacturer.

Rev. 20En – 10/2019 6

 NOXTEC: USER MANUAL

2. Symbols

Symbol Description

Note Provides additional information or clarification

Indicates the way of using the device properly and those conditions that
may damage it

Represents a hazardous situation regarding procedures or operating

WARNING conditions mentioned in this manual that may result in injury or death of
the user or the patient if operation is not correctly performed

Consult the instructions for use in this manual

Manufacturer

Serial number

Do not reuse, one use only

Applicable part type B

Gas inlet port

Gas outlet port

USB connector. This is only for connecting NTFS or FAT / FAT32

formatted USB memory for data and logs collection

Ethernet connector. This is for remote technical assistance only.

Storage and transport pressure limit; indication on the packaging.

Storage and transport relative humidity limit; indication on the

packaging.

Product reference

Rev. 20En – 10/2019 7

 NOXTEC: USER MANUAL

3. Safety warnings

- Read and follow all cautions and warnings.

- Read this manual before using NOXtec.
- To dose manually, if the device is not already dosing, it is necessary to disconnect
the dosing tube from the patient circuit and to vent the system.

Note: NOXtec does not automatically vent the circuit before starting to dose
manually.

- The use of accessories, transducers or cables not specified by ITC, S.A. may lead
to an increment in radiofrequency (RF) emissions or a decrement in the immunity
of the device.
- NOXtec is intended for using by healthcare professionals only. This device may
cause RF interference or may disturb the operation of devices closed to it.
Mitigation may be necessary, such as re-orientation or re-location of the NOXtec
or the other devices or the use of proper shielding.
- NOXtec needs special cautions regarding Electro-magnetic compatibility (EMC)
and needs to be installed and commissioned in accordance with EMC information
supplied.
- Portable and mobile RF communications devices can affect the device.
- NOXtec should not be used very closed or stacked with other devices. In case that
is strictly mandatory, it should be verified the device operates as expected in the
configuration that it will be used.
- Do not touch the enclosure of NOXtec if it is damaged to avoid possible
electrocution by accessing to 220 V.
- To avoid the risk of electric shock, this device should only be connected to a main
with protective earth.
- If the internal power supply of the device fails, do not replace it, or other internal
components, by your own. Do not use the unit and call to the specialized technical
support for assistance.
- Do not open the unit if you have not been trained previously for technical support
by the manufacturer of the product. Never touch the internal electronic boards
without proper electrostatic discharge protection.
- The unit incorporates an Ion-Lithium battery to power the unit in case of main
power failure. This must be replaced by qualified technical personnel only.
Incorrect replacement may cause a serious hazardous situation including
excessive temperatures, fire or explosion.
- Once the device is not dosing anymore, it is highly recommended to close the NO
cylinders and manually vent the inlet lines to depressurize the system.
- It is the responsibility of the user to replace the N2 / NO cylinder once it is
depleted to avoid treatment interruption and the consequent rebound of the
patient disease activity. Note that the option of automatic cylinder exchange can
be deactivated by the user, in which case, the device does not guarantee to
continue supplying gas to patient if the cylinder that is operative runs out (disabling
this functionality is not recommended for clinical applications).

Rev. 20En – 10/2019 8

 NOXTEC: USER MANUAL

4. Definitions and abbreviations

Abbreviation Description

NO Nitric Oxide

NO2 Nitrogen Dioxide

O2 Oxygen

N2 Nitrogen

ppm Parts per million

m Meters

mm Millimetres

kg Kilograms

L Litters

h Hour

min Minutes

s Seconds

°C Celsius degrees

V Volts

A Amps

HFOV Acronym of High-Frequency Oscillatory Ventilation

Hz Hertz

W Watts

EMC Electromagnetic compatibility

RF Radiofrequency

Respiratory flow Flow of gas from the ventilator to the patient in the inspiratory limb

Flow of NO injected to the inspiratory limb that is mixed with the

Dosing flow
respiratory flow to dose NO to the patient

Acronym of Electrically Erasable Programmable Read-Only

Memory. Type of memory that can be programmed, erased and
EEPROM
reprogrammed electrically. The data remains stored when the
memory is not powered electrically, or when the device is in off.

Rev. 20En – 10/2019 9

 NOXTEC: USER MANUAL

Rev. 20En – 10/2019 10

 NOXTEC: USER MANUAL

5. Introduction to this manual

This manual is the Instructions for Use of the models of NOXtec: NOXtec 1000 Nitric oxide
monitor and delivery system, NOXtec 2000 Nitric oxide monitor and delivery system (semi-
automatic and manual mode), and NOXtec 3000 Nitric oxide monitor. The essential aspects
to be able to use NOXtec safety, the intended use and the different modes of operation of the
device are included in this manual

It is very important to read this manual before using NOXtec. Images and diagrams are
included to make the use of the device easier.

This document is subject to periodic reviews.

For any query regarding this manual or about the use of NOXtec, please contact us:

Ingeniería y Técnicas Clínicas, S.A.

c/ Tungsteno, 11-15.
E-28500 – Arganda del Rey – Madrid – Spain
Phone: +34 91 871 99 50
E-mail: itcsal@[Link]

Rev. 20En – 10/2019 11

 NOXTEC: USER MANUAL

6. General description of the device

NOXtec is a device for measuring and monitoring nitric oxide. It is used for inhale NO
therapies for adults, children and new-borns. In addition, NOXtec monitors the concentration
of NO, NO2 as well as O2 delivered to patients.

The dosing, monitoring and user interface modules are autonomous and independent. This
means that, in a hypothetical failure situation in one of the modules, the others will continue
operating normally, ensuring the patient safety.

The thresholds of the monitoring module alarms are pre-programmed in an EEPROM to

ensure that in case of failure in the user interface will not affect the performance of the
audible alarms.

The NOXtec dosing module has an automatic NO cylinder exchange system that increases
unit autonomy and patient safety. Additionally, this module includes an automatic venting
system for replacing the gas into the internal pipes of the dosing module before starting to
deliver NO gas to the patient. This is for minimizing the undesirable concentrations of NO2
generated due to the reaction between the NO and the Oxygen when the gas is stationary in
the circuit that could be delivered to the patient at the beginning of the treatment.

The device has a venting port in the back panel for the evacuation of all the gases released
inside, minimizing the concentration of NO released to the room. This port should be driven
out of the room, connected to the extraction system of the room or connected to a
scavenging system. Note that gas exhaled by the patient is not conducted to the vent port
and should be treated independently. Different absorbents has been tested and approved.

1. Screen (LCD touch screen) 9. Manual purging for cylinder 1 (for 1000 and
2. Control button 2000)
3. On/Off button 10. Cylinder 1 inlet connection (for 1000 and
4. Ethernet port (for technical support only) 2000)
5. RS232 port (for reading the respiratory flow 11. Cylinder 1 pressure sensor connection (for
from some ventilator, not approved yet) 1000 and 2000)
6. Calibration gas inlet 12. Cylinder 2 pressure sensor connection (for
7. Manual purge of calibration gas 1000 ONLY)
8. Venting outlet 13. Cylinder 2 inlet connection (for 1000 ONLY)
14. Manual purging for cylinder 2 (for 1000
only)
15. Power cord connection

Rev. 20En – 10/2019 12

 NOXTEC: USER MANUAL

16. Water trap 21. Pneumatic connector for the differential

17. Manual flow control (bypass) for dosing pressure respiratory flow sensor (for 1000
18. USB port only)
19. NO dosing outlet (for 1000 and 2000) 22. Access lid for the gases (NO, NO2 and O2)
20. Hot wire respiratory flow sensor connector sensor manifold
(for 1000 only)

The table below shows the main differences between the models of NOXtec.

Automatic
Automatic calibration of
NOXtec Emergency manual NO flow
Dosing modes cylinder the NO, Purge
Model dosing mode (L/min)
exchange NO2 and
O2 sensors
Real time,
NOXtec Automatic, Semi- Automatic
Yes Yes Yes 0–4
1000 automatic & and manual
Manual
NOXtec Semi-automatic
No Yes Yes 0-1 Manual
2000 & Manual
NOXtec
_ No Yes No _ Manual
3000

6.1. Intended use

NOXtec is designed to dose NO concentrations to patients requiring this gas in
concentrations ranging from 0 to 100 ppm. The device is intended for the treatment of
persistent pulmonary hypertension in new-borns, for post-surgery patients with severe heart
disease, acute respiratory distress syndrome and other respiratory diseases. NOXtec 1000
is the full equipped device, NOXtec 2000 is the manual semi-automatic dosing system with
the monitor and NOXtec 3000 is the nitric oxide monitor only.

NOXtec measures the patient's respiratory flow and calculates the N2/NO flow (depending on
the NO concentration on the cylinder) required to dose a certain concentration of NO to the
patient. It also takes a sample of the gas supplied to the patient to measure the
concentration of O2, NO and NO2 in the mixture.

Rev. 20En – 10/2019 13

 NOXTEC: USER MANUAL

The device should be used by trained healthcare personnel for the treatment of new-borns,
children and adults. Patients with special needs such as new-borns or children should be
supervised by healthcare personnel throughout the treatment.

The device must be connected to the main and includes an internal battery for the supply for
a few hours. No connectivity to a server is required. The device is used in combination with
22mm, 15mm or 12mm ventilation tubes. Use only the disposable recommended by the
manufacturer.

It is not expected that the patient interacts with the device, but that it is handled by qualified
health personnel. NOXtec must only be installed by qualified personnel.

NOXtec should be used indoors, in dry places and with a temperature between +10°C and
40°C. The device is intended for use in a hospital environment. It incorporates a manual dose
bypass that can be used in case of device failure. The device is not approved extra-hospital
transportation.

NOXtec is intended for the treatment or alleviation of diseases. The computer has a RS232
port for synchronizing information with human ventilators (not released yet). Use only with
compatible ventilators certified by ITC S.A. The software of the unit can be updated locally and
remotely but only by authorized and qualified personnel.

6.2. Operating principle

NOXtec measures respiratory flow provided by the ventilator to the patient and delivers an
accurate dose of NO to the patient in a controlled and convenient manner. Additionally, the
device monitors the concentration of NO, NO2 and O2 that the patient is receiving sampling
the inspiratory limb as close as possible to the patient.

The usual concentrations of NO cylinders are 400, 800, 900 and 1000 ppm diluted in N2,
but it could be used with whatever cylinder from 200 to 1,500 ppm. The concentration of the
cylinders can be selected through the user interface and the information is stored in the
EEPROM of the dosing module. Note that the concentration of cylinders to be use with the
devices is configurable. If the cylinder the user wants to use is not in the list, contact with the
technical support for update the configuration of the device.

The cylinders incorporate pressure regulators to reduce the outlet pressure. These are
connected to NOXtec using self-sealing quick connectors. NOXtec measures the pressures
before and after the pressure regulators and has an automatic system to exchange them
when the one that is operative is below a pre-set threshold. It also includes a manual and
automatic purging system for venting the gas remaining into the low-pressure circuit, or in
the flexible hoses, for replacing the cylinder(s) and as well as before and after the therapy.

The cylinder gas is connected to the inlet connector of the dosing system; a normally open
pneumatic circuit composed by electro-valves and sensors. NOXtec also incorporates a
manual flow controller for dosing when the user requires it, in emergency situations or for
dosing under critical failure conditions.

Rev. 20En – 10/2019 14

 NOXTEC: USER MANUAL

The microcontroller that incorporates the dosing module receives the target dose in ppm,
selected through the user interface, and converts it into the required dosing flow as a
function of the respiratory flow defined and the concentration of gas in the cylinder in use.
Either manual or automatic dosing flows are monitored by a dosing flow sensor for increase
the device accuracy. When the device is dosing automatically, this measurement is used to
feed-back the dosing system and generate alarms in case the dose is out of specification
(high, low or unstable flow).

On the other hand, the NOXtec monitoring module allows visualizing the concentration of NO,
NO2 and O2 that the patient is receiving by sampling the gas through the water trap and the 3
gases sensors. These sensors have to be previously calibrated through the user interface
(configuration / automatic calibration) using with the calibration gas cylinder connected to
the rear input of the device.

The User Interface shows the NOXtec functionalities and the measurements, permits setting
the dose to the patient and guides the user throughout the use of the unit.

Rev. 20En – 10/2019 15

 NOXTEC: USER MANUAL

1. NOXtec device

2. Calibration cylinder

3. Exhausted gas

4. Ventilator

5. Inspiratory limb

6. Flow sensor

7. Dosing flow

8. Sampling flow

Fig. 6-1: General installation of the device in the respiratory circuit. Dosing system is only implemented in version
1000 and 2000 and the second NO cylinder and the flow sensor is only available in version NOXtec 1000

Rev. 20En – 10/2019 16

 NOXTEC: USER MANUAL

7. Unpackaging the device

Unpack the product and check that it contains the following items:

- Nitric Oxide Monitor and Deliver System NOXtec 1000, 2000 or 3000, according to
your order
NOXtec 1000:
- User manual
- Main power cord, according to your country standard and the specifications of your
order (1 unit)
- NOXtec Sensor module – MF4. The module of sensors is mounted inside the NOXtec
device (1 unit)
- Hot wire cable (1 unit)
- Pressure regulator for cylinder N2/NO, according to the specifications of your order
(2 units)
- Pressure regulator for calibration cylinder (1 unit)
- Calibration gas cylinder 5L (1 unit)
- NOXtec cart (1 unit)

NOXtec 2000
- User manual
- Main power cord, according to your country standard and the specifications of your
order (1 unit)
- NOXtec Sensor Module – MF4. The module of sensors is mounted inside the NOXtec
device (1 unit)
- Pressure regulator for cylinder N2/NO, according to the specifications of your order
(1 unit)
- Pressure regulator for calibration cylinder (1 unit)
- Calibration gas cylinder 5L (1 unit)
- NOXtec cart (1 unit)

NOXtec 3000
- User manual
- Main power cord, according to your country standard and the specifications of your
order (1 unit)
- NOXtec Sensor module – MF4. The module of sensors is mounted inside the NOXtec
device (1 unit)
- Pressure regulator for calibration cylinder (1 unit)
- Calibration gas cylinder 5L (1 unit)

Note: It is recommended to keep the device package in case you should later move the
device.

Rev. 20En – 10/2019 17

 NOXTEC: USER MANUAL

8. Parts and accessories

WARNING: Do not use or attach items not specified by the manufacturer.

Main Cable
01NTMGEG08 Main Cable EU
01NTMGEG18 Main Cable UK
01NTMGEG20 Main Cable USA
01NTMGEG22 Main Cable Israel
01NTMGEG23 Main Cable India
Fig. 8-1
Pressure regulator for cylinder N2/NO
10BiT3A2900X JUST PRESS B Supply NOXtec - ISO 5145 N29
10BiT3B3300X JUST PRESS B Supply NOXtec - CGA 330
10BiT3B6260X JUST PRESS B Supply NOXtec - CGA 626
10BiT3B6600X JUST PRESS B Supply NOXtec - CGA 660
10BiT3CM000X JUST PRESS B Supply NOXtec - ITC EP6 M
10BiT3D0300X JUST PRESS B Supply NOXtec - BS 341 N3
10BiT3D1400X JUST PRESS B Supply NOXtec - BS 341 N14
10BiT3E1400X JUST PRESS B Supply NOXtec - DIN 477 #14
JUST PRESS B Supply NOXtec - UNI 11144 Nº
1BiT3U050G1X
5
Fig. 8-2
Pressure regulator for calibration cylinder

10Bi02B3300X JUST PRESS B Calibration NOXtec - CGA 330

10Bi02CM000X JUST PRESS B Calibration NOXtec - ITC EP6 M

Fig. 8-3
Gases sensors block

01NTMNPG0A NOXtec - Sensors Module - MF4

Fig. 8-4
Water trap

01NTMNPG12 Neonate water trapping

01NTMNPG03 Adult water trapping

Fig. 8-5
External flow sensors
01NTSGDPPD Paediatric differential pressure sensor
01NTSGDPAD Adult differential pressure sensor
01NTSGMGD1 Disposable hot wire sensor
Fig. 8-6

Rev. 20En – 10/2019 18

 NOXTEC: USER MANUAL

Connectors
01NTSG0001 Straight connector 15F/22M -15F/22M
01NTSG0005 Straight connector 22F-22F
01NTSG0006 Straight connector 15M -22M
01NTSG0007 Straight connector 10M -15F
01NTSG0008 Straight connector 15M -22F
01NTSG0009 Straight connector 15M -15F
01NTSG0010 Straight connector 22M-22F
Fig. 8-7 01NTSG0011 Straight connector 15F -22F
01NTSG0012 Straight connector 15F -15F
01NTSG0013 Straight connector 10M -22M
01NTSG0016 Straight connector with F Luer
01NTSG0017 Straight connector 15F -10M
01NTSG0018 Straight connector 10M -22F
Fig. 8-8 01NTSG0019 Fixed elbow 22F-22F with port of 7.6 mm
Straight connector 10M -10F with port of 7.6
01NTSG0020
mm
Straight connector 10M -10M with port of
01NTSG0021
7.6 mm
Straight connector 10M -10M with port of
01NTSG0022
7.6 mm
01NTSG0023 Straight connector 10F – 10F
01NTSG2165 Straight connector 22M/15F-6,5 mm
Straight connector 22M -22F with port of 7.6
01NTSGADMF
mm
Straight connector 22M -22M with port of
01NTSGADMM
7.6 mm
01NTSGAWMM Straight connector 22M -22M without port
Straight connector 15M -15F with port of 7.6
01NTSGPDMF
mm
01NTSGPDMM Straight connector 15M/11,5F -15M/11,5F
01NTSGECLL Elbow connector” Luer Lock”

Tubes
01NTSG0002 Sample / dose line tube 3,0 m Luer-Lock Male
01NTMNPG04 Sample / dose line tube 1.8 m Luer-Lock Male
01NTSGAD30 Adult corrugated tube Ø22 mm

01NTSGPD30 New-born corrugated tube Ø15 mm

Fig. 8-9 Fig. 8-10

EGA Connector

12PSG1LT22A Elbow EGA connector

Fig. 8-11

Rev. 20En – 10/2019 19

 NOXTEC: USER MANUAL

Applicable parts of this device are all components described in the above table plus the
control button on the top of the device.

Function Specification Manufacturer Reference Length

3-way, phase, neutral and earth of 10A

220 V AC Generic Generic 1.8m
220v, IEC C13

6-way, special wire for hot wire (for 1000

Hot wire Sensirion N/A 2m
ONLY)

(optional, only for synchronization with

RS232 ventilators) Male, DB9 female, 9 ways, 3x Multicomp 11.99.6218 1.8m
twisted pairs. (for 1000 ONLY)

8.1. NO and NO2 absorbents

NOXtec has been tested and approved with SLE NO and NO2 absorbents. Consult to the
manufacturer if you want to use a different one.

Manufacturer Estimated saturation time

(for 20ppm dosing)

SLE More than 7 days

Rev. 20En – 10/2019 20

 NOXTEC: USER MANUAL

9. Connecting the device

1. Assemble the patient circuit as shown in the following image (Fig. 9-1). Note the
version NOXtec 2000 has not the flow sensor and the NOXtec 3000 only have the
sampling line with the T connector.

1. NOXtec device

2. Ventilator

3. Patient

4. Flow sensor

5. Dosing flow

6. Mixing chamber

7. Sampling flow

8. Exhausted gas

Fig. 9-1: Assembling diagram for NOXtec 1000

WARNING: Replace disposables before starting the treatment of a new patient. Use only the
disposables recommended by the device manufacturer.

Note: For choosing the respiratory flow sensor, see section “

Respiratory flow sensor”.

2. (ONLY for NOXtec 1000 and 2000) Connect the pressure regulators to the
cylinders: screw the nut onto the cylinder valve, using an appropriate wrench, keeping
the pressure gauge upright.

Note: The thread if the pressure regulator could be left hand

Rev. 20En – 10/2019 21

 NOXTEC: USER MANUAL

Fig. 9-2 Fig. 9-3

3. (ONLY for NOXtec 1000 and 2000) Insert the regulator hose connector to the NO
input port (“INLET”) and connect the regulator pressure sensor cable to the pressure
sensor connector (“SENSORS”).

Fig. 9-4 Fig. 9-5

Note: To remove the connector, slide the moving part as shown in Fig. 9-6 and Fig. 9-7.

Fig. 9-6 Fig. 9-7

4. Insert the calibration cylinder regulator hose connector to the calibration gas inlet
port (“Calibration”) as shown in Fig. 9-8 and Fig. 9-9.

Rev. 20En – 10/2019 22

 NOXTEC: USER MANUAL

Fig. 9-8 Fig. 9-9

Note: To remove the connector, slide the moving part as shown in Fig. 9-10.

Fig. 9-10

5. Connect the venting hose (Ø 22 mm) to the venting port (“Exhaust”).

Fig. 9-11 Fig. 9-12

6. Connect the other end of the venting hose to the exhaust system or move it to a
ventilated location.

Rev. 20En – 10/2019 23

 NOXTEC: USER MANUAL

Fig. 9-13

7. Connect the power cord.

Fig. 9-14 Fig. 9-15

WARNING: In the current version, the LAN port is used exclusively for remote maintenance.
Do not connect the device to the network when it is in clinical use.

WARNING: The USB port of the computer is exclusively for connecting a USB memory in
NTFS or FAT / FAT32 format for extracting data registers related with patients from the
device.

8. Locate the water trap in its receptacle and insert it until the "click",

Fig. 9-16 Fig. 9-17

Note: To remove the water trap, press the grey button on the top of the receptacle.

Rev. 20En – 10/2019 24

 NOXTEC: USER MANUAL

9. Connect one end of the sampling gas tube to the water trap and the other end into
the T-shape connector provided for this purpose in the patient circuit (Fig. 9-18 and
Fig. 9-19).

Fig. 9-18 Fig. 9-19

10. Connect one end of the dosing tube to the NO dose outlet ("DOSE") and the other end
into the connector provided for this purpose in the T-shape connector in the patient
circuit (Fig. 9-20 and Fig. 9-21).

Fig. 9-21

Fig. 9-20

11. (ONLY for NOXtec 1000) Connect the respiratory flow sensor end to the
corresponding connector in the side of the device. Connect the sensor in the
respiratory line ensuring that this part is connected just before the T shape piece
used to dose the gas to the circuit (far from the patient):

Rev. 20En – 10/2019 25

 NOXTEC: USER MANUAL

Fig. 9-22 Fig. 9-23

a. Differential pressure sensor: place the sensor in the patient circuit as shown
in step 1 and connect it to the differential pressure sensor ("Differential
pressure") connection as shown in Fig. 9-22 and Fig. 9-23. Note that blue
pneumatic port is connected in the inlet of the flow (to the ventilator).

b. Hot wire sensor: place the sensor in the patient circuit as shown in step 1
and connect it to the hot wire sensor ("FLOW SENSOR") connection as shown
in Fig. 9-24 and Fig. 9-25.

Fig. 9-24 Fig. 9-25

WARNING: Matching between the respiratory flow sensor and the water trap must be
verified to avoid unnecessary warning in the User Interface, i.e. if the sensor is adult the
water trap must be adult, if the sensor is neonate the water trap should be the neonate.

Rev. 20En – 10/2019 26

 NOXTEC: USER MANUAL

10. Initial checks

10.1. Before turning on

1. Check the caducity of the NO cylinders stated in the label attached.
2. Make sure that all connections have been made as described in section “9.
Connecting the device”.
3. Check that the device and its accessories are not damaged or wrongly connected,
and that they have not been used in another patient either.

WARNING: If the device, or the parts, are broken, deformed or visible contaminated then
device should not be used.

WARNING: The components of the patient circuit are for single use. Do not reuse then to
avoid microbial contamination.

4. Open the cylinders slowly and check their pressure on the pressure gauge included in
the pressure regulators.

Opening gas cylinder quickly can cause sudden increase of the pressure in the
regulator, damaging it and creating a hazardous situation.

Close the cylinder and check if the pressure in the gauge stays in the same position.
If the pressure is not maintained, the pressure regulator is leaking and should be
replaced.

10.2. Initial automatic system verification

1. Once the NOXtec is powered-on, the "System start-up" screen is shown for indicate
the evolution and results of the initial checking performed by the device. If the result
of all the testing is correct, NOXtec will continue to the main screen and is ready to
start a therapy.
2. If the critical control testing (left column) is passed and one of the secondary testing
(right column) fails, a warning will be displayed in the top of the screen and the user
can continue to the main screen pressing the "continue" button.

WARNING: User is the responsible to solve the problems detected before start using the
device with a patient. However, device will not allow starting dosing in a high-level alarm
condition.

Rev. 20En – 10/2019 27

 NOXTEC: USER MANUAL

Fig. 10-1

3. If one of the critical control testing (left column) fails, the device cannot be used. In
this case, the alarm window will appear (in the top) with red background and the
"continue" button will appear disabled. Restart the device to try to recover the unit
functionality. If there are not backup units, use the manual dose bypass in case of
emergency.

WARNING: If the errors found cannot be solved by restarting the system, contact a
specialized technical service.

Fig. 10-2

Rev. 20En – 10/2019 28

 NOXTEC: USER MANUAL

11. Operational dosing modes (ONLY for NOXtec 1000)

NOXtec dosing module can be operated in different modes that differ in the way the
respiratory flow is measured to calculate the flow required for dosing certain NO
concentration. These modes have been implemented to meet the needs of all users in
different applications (see the comparative table at the end of this section).

Note: The operational mode does not require to be changed often but during the device
setup or when the user wants to operate the device in different way. When the device is
turned on the operational mode selected is the one used last time in the unit.

11.1. Real time

In this mode, the respiratory flow is acquired 100 times per second and at each point the
dosing flow is recalculated and the proportional valves adjusted to ensure the dosing flow
follows all time the respiratory cycle of the ventilator.

11.2. Automatic
In this mode, the respiratory flow is acquired 100 times per second and is used for averaging
the ventilator flow during certain interval (defined as auto-mode time and can be between 5
and 20 seconds). The dosing flow is calculated and the proportional valves adjusted with the
timeout.

To check or set the automatic-mode time, see section “13.8.3 Dosing options (ONLY for
NOXtec 1000)”.

11.3. Semi-automatic
In this mode, the respiratory flow is entered manually on the main screen. The user has to
get from the ventilator the average respiratory flow received by the patient and types it
manually in the user interface. The dosing flow is only recalculated in this mode when the
respiratory flow value is manually changed or when the set dose value is updated by the user.

The semi-automatic mode is intended mainly for intra-hospital transportation or when the
respiratory circuit needs to be simplified as much as possible.

Fig. 11-1

Rev. 20En – 10/2019 29

 NOXTEC: USER MANUAL

Note: Some automatic dosing alarms are disabled in semi-automatic dosing mode. Gas
monitor alarms continue operating normally.

WARNING: The user is solely responsible for setting the respiratory flow correctly in the
User Interface. Incorrect setting of the respiratory flow could cause large differences
between the NO dosing setting point and the gas measurement.

11.4. Manual
In this mode the respiratory flow is not considered and the automatic dosing module is
deactivated. Dosing is done by means of the manual dosing bypass located on the right side
of the device. This is the default mode on the device. When the device is off, it is still possible
to dose NO to patient manually.

Note: Gas monitor alarms continue operating normally in manual mode but the alarm limits
must be set up manually and in ppm instead of percentage.

11.4.1. Emergency mode

For emergency situations, NOXtec has an emergency mode that works similarly as the
manual mode. It is possible to dose NO to patient manually when the device is turned off.

Firstly, to avoid stopping the NO dose during the therapy when an emergency situation
appears, use the manual table dosing on the right side of the device. This table allows the
user to select the position of the NOXtec manual flow control to dose approximately the
desired number of ppm considering the flow on the flowmeter.

If the user has to use the emergency mode and the device is turned off, the parameters can
be found following the same procedure.

Fig. 11-2

Rev. 20En – 10/2019 30

 NOXTEC: USER MANUAL

Ensure that the respiratory circuit is set as shown on the next figure:

Fig. 11-3

Once the previous points have been attended and the user wants to adjust the parameters,
follow the next steps.

Push the emergency button and the device shows the manual mode table. Press on the
screen to the square button that appears on the manual table dosing, which turns into blue
colour, and use the scroll to move horizontally to select the flow of the flowmeter.

When the flow is defined, push again on the scroll and decide the number of NO ppm moving
vertically. It these parameters are decided, push on the scroll to accept them and the button
turns into green colour.

On the green square, the user can find the position for the NOXtec manual flow control to
adjust the dose to the patient.

Rev. 20En – 10/2019 31

 NOXTEC: USER MANUAL

Mode Respiratory flow Recommended use

Real-time Measure every 10ms For variable ventilatory cycles with

and immediate medium and low frequency of change of
correction of dosing flow. the respiratory flow.

Automatic Averaging during the For ventilatory cycles with medium and
time of the automatic high frequency respiratory flow changes.
mode.

Semi-automatic Manually defined by the For situations when the respiratory flow
user. sensor makes other manoeuvres difficult
or for short distance patient intra-hospital
transportation.

Manual Not measured. Safety mode for situations when the

automatic dosing system is failing. In
Dosing flow manually
emergency situations.
controlled by the flow
regulator.

Rev. 20En – 10/2019 32

 NOXTEC: USER MANUAL

(SPACE TO INSERT THE MANUAL MODE TABLE)

Rev. 20En – 10/2019 33

 NOXTEC: USER MANUAL

12. Respiratory flow sensor (ONLY for NOXtec 1000)

The advantages and limitations of the respiratory flow sensors incorporated into the unit are
summarized in the following table:

Sensor Measurement range Advantages Disadvantages

Adult differential Fast response, low

2 – 120 L/min Lower accuracy
pressure cost, easy
replacement
Higher flow range Incompatible with
New-born differential for adult applications HFOV for
0.5 – 60 L/min
pressure frequencies higher
Easy to connect in
than 3Hz
the ventilatory circuit

Adult hot wire 0.5 – 100 L/min Accurate across the

range Lower flow range
Faster response. More difficult to
New-born hot wire connect in the
0.2 – 30 L/min
(No available yet) Fully compatible with ventilatory circuit
HFOV

Rev. 20En – 10/2019 34

 NOXTEC: USER MANUAL

13. General user interface

The main screen of the User Interface allows the user to access to the most used
parameters during the therapy and shows the measurement of the gases received by the
patient, as well as other measures required for the unit control. The User Interface can be
operated by the touch screen (not all functionalities) or by the control button in the top of the
device.

Fig. 13-1

13.1. Control button

NOXtec has a control button for navigating through the different options and menus and for
setting the desired values (see Fig. 13-2).

Turn the button clockwise or anticlockwise to scroll through the menus and for increasing the
values when they are selected.

Fig. 13-2

Push down the button until "click" is perceived to select an option or confirm a new value.

Rev. 20En – 10/2019 35

 NOXTEC: USER MANUAL

Fig. 13-3

The appointed icon or device functionality in the menu is shown with the background in green
colour. When that icon or functionality is selected for change, it will be shown with cyan
background.

13.2. Patient identification

When NOXtec is started, or the user selects the option to start with a new patient (see
below), the window for patient identification is displayed. The treatment id can be entered
manually or by a barcode scanner connected to the USB port.

Fig. 13-4

When identification is entered and accepted by the device, it is displayed in the central top
side of the user interface (see Fig. 13-5).

Fig. 13-5

For starting a new treatment without cycling OFF and ON the unit, follow the next steps:

Rev. 20En – 10/2019 36

 NOXTEC: USER MANUAL

13.3. Main screen

Fig. 13-6. Parameters of the NOXtec main screen

13.4. Checks before start dosing

Once the user is in the main screen, this is recommended to verify certain parameters
before starting dosing:
1. Verify there are no alarms. Alarm situation must be solved in order to start dosing
with the device (see section “16. Alarms“).
2. Check the battery level.

Fig. 13-7 Fig. 13-8

Note: NOXtec is connected to the mains and Note: NOXtec is not connected to the
the battery level is 100%. mains, the battery level is 98% and the
expected autonomy is 5h 50min.

Rev. 20En – 10/2019 37

 NOXTEC: USER MANUAL

In case it is required a replacement of the battery, this must be carried out

by qualified technical personnel in accordance with the manufacturer's
instructions.

3. (ONLY for NOXtec 1000) Check that the respiratory flow sensor selected on the
device is correct.

Fig. 13-9

a. To change the selection of respiratory flow sensor, follow the next steps:

4. Turn around and press the control button to access to the available options. See the
operation of the control button in section “[Link] button”.

5. (ONLY for NOXtec 1000) Check that the NO concentration of the cylinders is
properly set in the device.

WARNING: Incorrect selection of the NO concentration of the cylinders can cause patient
to be over or under dose.

Fig. 13-10

To change it, follow the next steps:

Rev. 20En – 10/2019 38

 NOXTEC: USER MANUAL

Note: Concentration of NO in the cylinder can only be changed with Technical Profile right.

WARNING: The estimated treatment time with the cylinder in use is referential and should
not be used for calculating the next time the device must be checked.

6. (ONLY for NOXtec 1000) Check that the cylinder volume is correct. To check and /
or modify it follow the next steps:

7. Carry out an automatic calibration of the gases sensors as described in section

“15.1 Automatic calibration of gases sensors”.

13.5. Dose start (ONLY for NOXtec 1000)

Once the recommended verifications are completed, the device is ready to start dosing. It is
forbidden starting dosing in the event of any high-level alarm condition.

Rotate the control button until the background of the dosing icon is green. Press the control
button and turn it anti-clockwise again to increase the value of the NO setting box (NO set
point) up to the desired dosing value.

The dosing can be selected by the touch screen and it changes to blue colour (Fig. 13-12).
The value of ppm can be increased 5 to 5 ppm using the button “up to 5” and it returns
automatically to 0 ppm pressing the button “down to 0”.

Fig. 13-11 Fig. 13-12

Note that the maximum permitted dosing value is that one appearing on the top of the dosing
icon

To change the maximum permitted dosing value, follow the following steps:

Rev. 20En – 10/2019 39

 NOXTEC: USER MANUAL

Note: Maximum NO allowed can be only modified by user with Technical or Supervisor
rights.

When the user confirms a new set point, a message box will appear for confirming the
parameters for dosing are those expected. If the selected dose exceeds the 20 ppm, the pop
up message will be shown as in Fig. 13-12.

Fig. 13-12

If the selected dose exceeds 40 ppm, the message will be shown as in Fig. 13-13.

Fig. 13-13

Many factors could affect the accuracy of the expected dose: a) the actual gas concentration
of the treatment cylinders, b) the accuracy of the gas monitor, c) the dosing flow accuracy, c)
the accuracy of the respiratory flow sensors, and d) the connection of the respiratory circuit,
including possible leaking. NOXtec implements a correction factor that could be used to
correct the difference between the dosing set and the concentration measured in the
monitor up to +/- 20%.

Rev. 20En – 10/2019 40

 NOXTEC: USER MANUAL

This correction factor is only available for NOXtec 1000 with real time, automatic or semi-
automatic dosing mode. It could be apply only in absent of alarm condition and when the
measurement is stable (more than 1minutes after the last dosing setting change),

1. Before start dosing, the correction factor is displayed at the bottom left corner of the
NO area (0% in the example).

2. Start dosing. When the device completes the automatic venting process, there will be
a stability time of 1minute to ensure the gas dose to the inspiratory limb is properly
mixed and delivered to the patient. When this time is timeout, touch on the NO value
to trigger the calculation of the percentage difference between the NO measurement
and the set point and the correction will be applied in the device.

13.6. Locking the User Interface

There is a button in the user interface to lock all the functionality of it. This prevents
accidental manipulation of the control button or the touch screen which may cause
undesirable or dangerous manoeuvring. Those functionalities disabled in the user interface
will be presented greyed-out.

When the lock icon is pressed for unlocking the User Interface, a confirmation window is
shown. The user profile can be selected between standard (optional available), supervisor or

Rev. 20En – 10/2019 41

 NOXTEC: USER MANUAL

technical. If standard or supervisor user is selected the Interface will be unlocked with
restricted access. The technical user profile will have full access to the device functionalities.
Click in user for selecting the user and type the password for unlock the device with that
advanced user profiles. The lower level user (standard or supervisor if the standard is not
enabled) does not require of password for unlock the unit.

Fig. 13-14 Fig. 13-15

13.7. Muting the audible alarms

In the user interface a button is added to mute the audible system alarms. This avoids
unwanted sounds when the user is aware of the alarm or warning situation. When the
audible alarm is muted, the icon on the button changes to “audio off” or “audio paused” (Fig.
13-16: no alarm, Fig. 13-17: active alarm, Fig. 13-18: audio permanently muted (only for low-
level alarms or warnings), Fig. 13-189: audio temporarily muted (only for high-level alarms).

Fig. 13-16 Fig. 13-17 Fig. 13-18 Fig. 13-19

Note: When the audible alarm corresponds to a high-level alarm (see section “16.
Alarms”), the alarm muting is not permanent and will be automatically unmuted after 1
minute (audio paused).

Note: When the audible alarm is muted, the visual alarm remains on in the user interface
main window.

Rev. 20En – 10/2019 42

 NOXTEC: USER MANUAL

13.8. Settings
The setting is partially available for supervisor profile (less functionality) and for technical
user. The unit settings are divided in four groups:

a) Calibrate: for performing the calibration of the gases sensor, verify them, calibrating
the flow sensor, displaying the flow for the different positions of the manual bypass
flow controller and measure the concentration of gases in the room.
b) Monitor: is used for enabling the change of alarm thresholds and for setting the
concentration of gases into the calibration cylinder.
c) Dosing: is used for setting the dosing module parameters.
d) Technical (only for technical user profile): for the rest of the parameters that do not
require continuous access.

Note: When one of the options is modified, the font colour of the changed parameter is
greyed-out and when it has been correctly programmed on the corresponding module, it
returns to yellow colour as confirmation. If it is not returned in 5 second, repeat the
operation.

13.8.1. Calibrate options

In the calibrate area, the following functions can be accessed (see Fig. 13-20)

- Autocalib: to perform an automatic calibration of the gases sensors (See section “15.1-
Automatic Calibration of Gases Sensors”).
- Verify: to verifies the calibration of the gases sensors (See section “15.2- Verifying the
Calibration”).
- Room: to measure the NO, NO2 and O2 concentration on the room. The duration of the
procedure is under a minute. During that time, the patient won’t be monitored.
- Calib flow: To calibrate the high and low-flow proportional valves automatically.
- Bypass: To show the flow in the 12 positions of the manual bypass flow controller.

WARNING: Do perform room gases measurement only when patient is in stable treatment
conditions.

Rev. 20En – 10/2019 43

 NOXTEC: USER MANUAL

Fig. 13-20

13.8.2. Monitoring options

Fig. 13-191

In the monitoring area, the following options can be accessed (see Fig. 13-191):

- Enable or disable the change of the gases alarms thresholds: (see section “16.
Alarms”). When these values are enabled, the setting window is closed and the gases
alarm threshold values on the main screen are now editable, appearing with the fonts
in yellow.

Rev. 20En – 10/2019 44

 NOXTEC: USER MANUAL

Fig. 13-202

WARNING: The gases alarms thresholds can be modified in any of the dosing modes. If
NOXtec is using manual mode, the gases alarms thresholds are changed and when it
returns to another different mode, the device does not keep the first gases alarms
thresholds and the user has to select the new thresholds manually.

- Calibration NO value: to edit the value for the automatic calibration of the gases
sensors. When the user connects the calibration cylinder to the device, the quality
certificate attached to the cylinder should be read and the actual NO concentration
typed in this position. The offset of the NO is taken passing air through the sensors.

- Calibration NO2 value: to edit the value for the automatic calibration of the gases
sensors. When the user connects the calibration cylinder to the device, the quality
certificate attached to the cylinder should be read and the actual NO2 concentration
typed in this position. The offset of the NO2 is taken passing air through the sensors.

- Calibration lowest O2 value: to edit the value for the automatic calibration of the gases
sensor. Because the typical cylinders that include NO should not contain O2 for
avoiding reaction, this value is typically zero.

- Calibration highest O2 value: to edit the value for the automatic calibration of the
gases sensor. It is typically the 20.1% of the air.

- Pressure calibration cylinder: This is a read only field that is for reading the pressure
after the pressure regulator to check if the calibration gas is still operative.

13.8.3. Dosing options (ONLY for NOXtec 1000)

In the dosing area, the following functions can be accessed (see Fig. 13-23):

Rev. 20En – 10/2019 45

 NOXTEC: USER MANUAL

Fig. 13-23
- Cylinder exchange: allows the user to swap the cylinder in use and the backup one
manually (see section “
- Cylinder exchange (only available for authorized users and version NOXtec 1000)” for
other ways of proceeding to exchange the cylinder).
Note: for swapping the cylinders, it is necessary that the backup cylinder has enough gas
and the low pressure of the regulator is operating correctly (in the range of 3.0 to 6.0 bar).

- Change of respiratory flow sensor: allows the user to check or change the respiratory
flow sensor (see section “

Rev. 20En – 10/2019 46

 NOXTEC: USER MANUAL

- Respiratory flow sensor”). The options available are as shown below:

Note: The respiratory flow sensor cannot be changed during dosing. This option will be
disabled.

- Dosing modes: allow changing dosing modes (see section “11. Operational dosing
modes”). The available options are as follows:

- Automatic mode time: allows setting the time during which the measurement of the
respiratory flow in automatic mode will be averaged to correct the dosing flow (see
section “11.2. Automatic”). This parameter can be changed in any mode despite it will
only appear in yellow when the device is in automatic mode. This value must be set
between 3 and 20 seconds.

To check or set the automatic mode time, follow these steps:

- Maximum NO dose allowed (for 1000 only): has been described in section “13.5.
Dose start”. This parameter has to be selected between 20 and 100ppm.

13.8.4. Advanced settings (ONLY for NOXtec 1000 and partially for NOXtec 2000)

In the advanced settings you can access the following functions (see Fig. 13-24):

- NO cylinder volume (for 1000 only): corresponds to the volume of the NO cylinder
used. Refer to cylinder information to set this parameter (see section “13.4. Checks
before start dosing”). This parameter has to be set between 2 and 20L.

- Cylinder NO concentration (for 1000 only): corresponds to the NO concentration in

N2 that appears on the cylinder quality label. This parameter is selected from a pre-
set list between 200 and 1500ppm.

Note: The cylinder quality label could specify the measurement of the actual concentration
of the gases. In this setting, only the nominal value is required, for example: 400 or
600ppm.

Rev. 20En – 10/2019 47

 NOXTEC: USER MANUAL

Fig. 13-24
- Cylinder pressure for warning: defines the threshold below which a visual and audible
warning will be activated to indicate to the user that the amount of gas in the cylinder
is low (see section “14.

- Cylinder exchange (only available for authorized users and version NOXtec 1000).
This parameter can be adjusted between the automatic exchange pressure (see
below) and 50bar.
- Critical cylinder pressure (or pressure for cylinder alarm): value on which the
automatic cylinder exchange is performed, if this option is enabled (see section “14.

- Cylinder exchange (only available for authorized users and version NOXtec 1000)”),
or it will generate a high-level alarm to indicate that the gas in the cylinder in use is
about to run out. This value can be adjusted between 7bar and the cylinder pressure
for warning described above.
- Automatic cylinder exchange selection: see section “14.

- Cylinder exchange (only available for authorized users and version NOXtec 1000)”.

- Alarm level for critical battery: allows you to change the value below which the high-
level alarm for critical region battery is activated. This value can be selected between
10 and 25%.

- Language: NOXtec can be configured to present the user interface in different

languages: English, Spanish, Italian and German.

Note: All displayed languages may not be available on your NOXtec.

13.9. Showing the treatment data and log and downloading save studies
NOXtec has an option to show the current treatment information. This information is
composed of two files: measurements (gases measurements, pressures, flow, etc.) and logs
of the system that is the status of the device modules (alarms, operations, commands, etc.).

Rev. 20En – 10/2019 48

 NOXTEC: USER MANUAL

These files are in binary format and can be viewed using the external software NOXtec
viewer.

Measurements are taken every 20 seconds and are graphical accessible through the User
Interface selecting the option history (Fig. 13-215).

Fig. 13-215

An example of the data registered by the system is shown in Figure 13.26.

Fig 13-26

To export the treatment information or data via USB, follow these steps:
1. Connect a memory stick to the USB port.
2. Go to the option described next

3. Disconnect the memory stick from the device.

13.10. Turning off the device

Note: NOXtec should not be turned off when the device is dosing.

Rev. 20En – 10/2019 49

 NOXTEC: USER MANUAL

For turning the device off, it is mandatory to stop dosing. If the device is in emergency mode
and it was previously used in semi-automatic, automatic or real-time mode, it is mandatory to
change to semi-automatic, automatic or real-time mode for stop dosing.
Once the device is in Standby mode, follow the next steps for starting the turning off process:

This sequence will trigger the turning off process (see the figure above) Follow the instruction
of the turning off window for a safety off condition. It is necessary to close the NO cylinders
and to vent the pressure line manually to ensure the device is not pressurised when not
working. For venting the device manually, press the manual purge buttons (“PURGE”).

Note: It is recommended to open the manual flow regulator (bypass) to the maximum for
about 10 seconds to depressurize the dosing outlet when the device is off.

WARNING: Be aware of disconnecting the dosing tube if the patient is still connected to the
ventilatory circuit.

13.11. Help
NOXtec has a help menu with different options (Fig. 13-227).

Fig. 13-227
- Alarms: It is an interactive help with the normal situations that can provoke alarms to
appear. Common actions are also included like changing the NO cylinders, connecting
the respiratory flow sensor, turning off the device, etc. To access to it, follow the next
steps:
- Device: this menu also shows the data of the device as the version of the software,
the date of manufacture, etc. To view this data:

Rev. 20En – 10/2019 50

 NOXTEC: USER MANUAL

14. Cylinder exchange (only available for authorized users

and version NOXtec 1000)
NOXtec measures the high pressure into the cylinders and uses these for swap the cylinders
automatically when the one in service is below a pre-set threshold (“critical pressure”). The
device performs an automatic purging before one cylinder enter into operation to ensure the
NO gas into the low-pressure pipes, that is potentially reacting with the oxygen of the air and
generating NO2, is vented instead of delivered to the patient. This functionality can be disabled
by mean of the user interface.

To enable / disable automatic cylinder exchange follow the next steps:

To set the exchange threshold, follow the next steps:

Once the high pressure in the operative cylinder reaches this threshold, this will be swap to
the backup one automatically.

Note: Cylinder exchange is executed when the unit is dosing.

Note: The operative cylinder is identified in the User Interface with the background in green.

Rev. 20En – 10/2019 51

 NOXTEC: USER MANUAL

Fig. 14-1

Note: Whenever a cylinder is exchanged or just before starting dosing, an automatic

venting of the gas into the device internal pipes is performed.

If the automatic cylinder exchange option is disabled, the device will generate a high-level
alarm if the high pressure of the cylinder in operation is down the threshold, does not matter
what is the state of the backup cylinder. Additionally, NOXtec has a warning level that must be
at least 1 bar higher than the threshold value. This is used for generating a low-level alarm if
the high pressure in the operative cylinder is lower than the threshold value and the backup
cylinder is not ready for operation or the automatic cylinder exchange functionality is disabled.
To set this warning threshold, follow the next steps:

NOXtec generates a warning when the operative cylinder is about running out (lower than
pressure warning level) and the backup one is ready for use (Fig. 14-2):

Fig. 14-2

When one cylinder is lower than the critical cylinder pressure, and the other one is higher
than that level but lower than the pressure warning level, a low-level alarm will be generated
(Fig. 14-3):

Fig. 14-3

When both cylinders are lower than the critical cylinder pressure, a high-level alarm will be
generated (Fig. 14-4):

Fig. 14-4

Cylinder can also be changed manually following the next steps:

Rev. 20En – 10/2019 52

 NOXTEC: USER MANUAL

WARNING: The user is responsible for replacing the cylinder(s) before it is completely
exhausted to avoid a hazardous situation to the patient.

WARNING: The user is entirely responsible for the quality of the NO gas cylinder used with
the device. The manufacturer only recommends the use of medical grade NO gases.

To replace the NO gas cylinder, follow the next steps:

1. Close the cylinder valve.

2. Purge manually the system channel by pressing the corresponding manual purge
button ("PURGE").

Fig. 14-5

3. Verify in the user interface that the high-pressure value of the cylinder to be replaced
is 0 bar or near.
4. Disconnect the hose from the back of the device (inlet), the sensor cable (Sensors)
and the pressure regulator from the cylinder.
5. Remove the depleted cylinder and replace it with another one of the same
characteristics. Connect it as described in section “9. Connecting the device”.

WARNING: Do not leave the gas cylinders in an unstable or unsafe position. This can cause
accidents.

Rev. 20En – 10/2019 53

 NOXTEC: USER MANUAL

WARNING: Only cylinders with the same concentration of NO can be connected at the same
time to the NOXtec inlet.

Rev. 20En – 10/2019 54

 NOXTEC: USER MANUAL

15. Monitor calibration (only available for authorized

users)

15.1. Automatic calibration of gases sensors

Note: It is recommended to carry out an automatic calibration before starting a new

treatment.

To perform automatic calibration, connect the calibration cylinder regulator to the calibration
gas inlet port (“Calibration”).

Fig. 15-1

Slowly open the calibration cylinder and check its pressure in the regulator gauge. Close it for
30 seconds and verify the pressure is not dropping meaning the regulator is not leaking.

If the cylinder is opened quickly, the pressure in the regulator can increased suddenly
creating a potential hazardous situation.

Close the cylinder and reject the pressure regulator if it is leaking.

Enter or check calibration target values for NO and NO2 according to the calibration cylinder
label following the next steps:

Rev. 20En – 10/2019 55

 NOXTEC: USER MANUAL

Note: Calibration parameters for oxygen cannot be modified by the user.

The automatic calibration can be performed following the next steps:

Note: Remove the sampling tube from the water-trap as shown in the video before starting
the calibration process.

Note: Automatic calibration can be performed during patient treatment.

Before starting the calibration, the sampling tube must be removed from the water-trap to
ensure the correct offset condition.

Fig. 15-2

When the calibration is taking place, the User Interface appears as below.

Fig. 15-3

WARNING: The calibration process is indicated with the text “cal” in the monitor
measurements.

Rev. 20En – 10/2019 56

 NOXTEC: USER MANUAL

At the end of the calibration process, the result is presented in red when fail or in green when
it was performed successfully (see Fig 15-4).

Fig. 15-4

WARNING: Reconnect the sampling tube to the water trap at the end of the calibration as
it is shown in the video.

The accuracy of the gases sensors decreases around the 3% each month. Due to this, it is
required perform the calibration of the gases sensors each month.

15.2. Verification of the calibration

During the treatment, the calibration of the gases sensors can be verified. This process is
based on passing the gas from the cylinder trough the sensors for measuring their
concentrations.

To perform this verification automatic calibration, connect the calibration cylinder regulator
to the calibration gas inlet port (“Calibration”) (see Fig. 9-8 and Fig. 15-). Follow the next steps:

The calibration is successful if the concentration values of NO, NO2 and O2 do not differ by 8%
from the target values and the font of the measurements will be represented in green colour.

Rev. 20En – 10/2019 57

 NOXTEC: USER MANUAL

16. Alarms

Alarm Level Description Action Limits

Dosing module (ONLY for version 1000 and partially 2000)

Reboot the system, No limits

The dosing module is
Failure state High otherwise call for
not operative
technical support
Both cylinders are
empty or the cylinder in
High use is empty and the
automatic exchange
function is disabled
Replace cylinder or turn Defined by the user
Content of the The cylinder in use is the automatic cylinder “settings –
cylinder below the warning exchange function on advanced” ± 1 bar
threshold and the
Medium automatic exchange
function is disabled or
the backup cylinder is
empty
The pressure of the
cylinder-in-use regulator
Low pressure is out of range and the Check the pressure
Pressure in the
in the pressure of the backup regulator of the
inlet of the device
regulator (only Medium cylinder regulator is also cylinders. Turn on the
must be between
NOXtec out of range or the automatic cylinder
3.5 and 5.5 bar
1000) automatic cylinder exchange function
exchange function is
disabled
Set the dose according Regulated
Internal
The internal pressure to the NO measure in pressure must be
regulated Medium
regulated is out of limits the monitor or use between 1.7 and
pressure
manual mode 2.3 bar
Check the venting line or Venting relative
Vent line
Venting line obstructed disconnect the device pressure must be
(ONLY for
Medium or with excessive from the extraction line. higher than 0 bar
NOXtec
vacuum Connect a 22mm tubing and most not
1000)
to a ventilated place exceed 1 bar
Leaking by Dosing flow is
Device is measuring Device could be in
dosing outlet higher than 25
unexpected flow emergency or standby
(ONLY for Medium mL/min and
throughout the dosing mode with the manual
NOXtec device is not in
port dosing bypass open
1000) manual mode
Respiratory
flow sensor Replace respiratory flow Error in the hot-
Error in selected
(ONLY for High sensor. Call technical wire or differential
respiratory flow sensor
NOXtec service pressure sensor
1000)

Rev. 20En – 10/2019 58

 NOXTEC: USER MANUAL

Alarm Level Description Action Limits

Monitoring module
Reboot the system,
The monitor module is
Failure state High otherwise call for No limits
not operative
technical service.
Reboot the system.
Otherwise, turn off the
Battery fault High Battery is malfunctioning No limits
device and report to
technical service
The sampling
pump or pressure
regulator control
are out of the
Check the correct
Flow or range between
The pressure or flow connection of the
pressure in 200 and 700 UR.
Medium inside the gases sensor sensors block.
sensor out of The flow and / or
chamber is out of range Otherwise, call to the
control the pressure are
technical support
out of range of ±5
mL/min or ±5
mbar respect to
the target
Check that the sampling The flow througn
Sampling line There is an obstruction tube is not obstructed, the sensors is
High
obstruction in the sampling line and that the water trap less than 10
is not full. mL/min
Check the system or NO measurement
The NO concentration is relax the alarm out of the
NO
High outside the thresholds thresholds if possible. established range
concentration
specified Use the compensation in the User
factor option. Interface
Check the ventilatory NO 2

The NO concentration is
2 circuit. Verify that the measurement out
NO 2
High outside the thresholds respiratory flow is of the established
concentration
specified correct. Relax alarm range in the User
thresholds if possible. Interface
Increase the O 2 O measurement
2

concentration in the out of the

The O concentration is
2
O2 ventilator or add oxygen established range
High outside the thresholds
concentration in the inspiratory line. in the User
specified
Relax alarm thresholds Interface
if possible
Connect the Water-trap
corresponding water disconnected
The water trap is not
Water trap High trap according to the from the
connected
patient under study receptacle
(adult or neonate).
Connect the device cord Defined by the
Battery The battery charge is to the main or turn it off user “settings
High
depleted below the set limit and use the manual monitor” ± 1 %
bypass for dosing

Rev. 20En – 10/2019 59

 NOXTEC: USER MANUAL

Alarm Level Description Action Limits

Temperature
above 70°C.
Immediately turn off the
Operative
Battery The battery temperature device and disconnect
High condition is
temperature is too high the power cord. Use the
recovered when
manual mode for dosing
temperature is
below 60°C

In all cases, the position of the user respects the device for detecting and solving the problem
that is creating the alarm condition must be 4m around the device.

System alarms are determined in most of the cases by comparing the measurement of the
corresponding parameter with the thresholds established for it. If the alarm is constantly
repeated for a period of time between 2 and 10 seconds depending on the alarm, the alarm
condition is displayed. This delay does not change during system operation.

The system will only display those alarms enabled of the highest level. It means that if the
system has a high-level alarm on the monitor module and another high-level on the dosing
module, these will be shown together, but if the alarm in the dosing module is a medium-level,
this one will be omitted until the high-level alarm(s) is clear.

The system does not have audio volume control.

The "audio off”/”audio pause" option with a high-level alarm will mute the alarm for a period of
1 minute. Otherwise, the audible alarm will be interrupted indefinitely or until another alarm
condition appears.

Similarly, other parameters of the alarm such as tone, rhythm, volume, etc., do not change
during the use of the unit.

WARNING: Observe the alarm limits given in the table above and avoid disabling system
alarms inadvertently.

WARNING: All system alarms have a time delay of 1 to 10 seconds.

The visual alarms appear in the upper right of the User Interface as shown in Fig. 14-3.
Audible alarms are generated with a specific pattern that identifies the level of the alarm. The
visual and audible difference of high level, low level alarms and warnings is summarized in the
following table:

Alarm type Visual Audible

BACKGROUND: alternating The next pulse train* is repeated twice

between red and black every 8 seconds
High level
FONTS: Alternating between
white and red
BACKGROUND: alternating The next pulse train** is repeated once
between yellow and black every 10 seconds
Medium level
FONTS: alternating between black
and yellow

Rev. 20En – 10/2019 60

 NOXTEC: USER MANUAL

Alarm type Visual Audible

BACKGROUND: cyan Two pulses of 130 ms spaced 190 ms

Information
FONTS: black every 18 seconds
No alarm Device identification logo Nothing

* The pattern consists in: 110 ms of audio bursts, 80ms of silence between the 1st and the
2nd, the 2nd and the 3rd, and the 4th and the 5th, and 250ms between the 3rd and the 4th.
Timing between the two pulses train repetition is 850 ms.

** The pattern consists in: three audio bursts of 130 ms separated 190 ms.

16.1. Alarm system verification

Both audible and visual alarm in both monitor and dosing modules must be checked
periodically to ensure they are working correctly. Because both module alarms operate
independently, they must be checked independently.

To check the monitor alarm, remove the water trap from the right side of the unit. In the
alarm area of the main screen, a high-level alarm will appear indicating the water trap is not
installed. The alarm must be audible perceptible as indicated in the table above.

To check the dosing alarm, disconnect both high pressure sensors from the back of the unit
or close both cylinders and vent the hose using the manual venting push-button in the back of
the device. A high-level alarm will appear indicating the cylinders are exhausted.

Rev. 20En – 10/2019 61

 NOXTEC: USER MANUAL

17. Training courses required for the use of NOXtec

Some initial and periodic training are required for the use, commercialization and servicing of
NOXtec. The description of the courses, duration, frequency, objective and the target user
profiles are summarized in the next table.

Training
Frequency Duration General objectives User profile
course

Annual, if Use of inhaled NO in patients,

Clinical device is not 8 hours with installation into the ventilatory Clinical
training used practical test circuit, applications and safety personnel
regularly measures
Initially 24 Technical
hours with 8 Installation, periodic review, personnel,
Technical
Annual hours in general verification, replacement preferably with
formation
successive of gases sensors, etc. knowledge of
sessions ventilation
Carriers and
Cylinder installation and technical
Carrier 4 hours with personnel in
Annual replacement, assembly and
training practice test hospitals.
disassembly of the system
Paramedics

Rev. 20En – 10/2019 62

 NOXTEC: USER MANUAL

18. Warranty
ITC, S.A. warrants this product against any manufacturing defect or in materials for one year
from the date of purchase.

The warranty includes repairing, replacing or changing the product and/or components free
of charge to the customer, including labour and materials. Transport costs are not included.

This warranty does not include disposable, consumables or accessories such elements of the
patient circuit, respiratory flow sensor, gases sensors or cylinder with calibration gases
(included in maintenance contract, see conditions).

This warranty will not be valid under the following conditions:

- When the use and the care of the device have not been in accordance with the
instructions contained in this manual.
- When the fault is caused by incorrect use of the unit.
- When the product has been opened or maintained by personnel or companies not
authorized and trained by ITC, S.A.

Rev. 20En – 10/2019 63

 NOXTEC: USER MANUAL

19. Cleaning

WARNING: Before cleaning the device, turn it off and unplug it from the main.

Clean the device with a damp cloth impregnated with a mild detergent. It is important to dry
the device after cleaning.

Use standard wipes for surface disinfections and cleaning the body of the unit, terminals and
appliances. The touch screen can be clean with wipes with ammonium for better disinfection.

Do not sterilize the device in a steam autoclave or with liquid.

Do not use grease or oils for cleaning. Some of them may be incompatible with
oxygen creating fire or explosion.

Rev. 20En – 10/2019 64

 NOXTEC: USER MANUAL

20. Technical specifications

20.1. Physical specifications
Dimensions Main unit 190 x 300 x 345 mm
(height x width x length) Trolley 1250 x 565 x 630 mm
Main unit 8.4 kg
Weight
Trolley 41.5 kg
Cylinders Capacity 2 x 20 L
Materials Stainless steel AISI 304 and AISI 316, PTFE and ABS
IP classification 20

20.2. Operating and storage conditions

Temperature Humidity Relative pressure

Operating conditions 10 – 40 °C 15 – 90 % 65.0 – 101.5 kPa

Storage conditions -10 – 60 ° C 15 – 90 % 50.0 – 101.5 kPa

20.3. Monitoring module

NO: 4 electrodes electrochemical

Measuring principle of gases sensors NO : 4 electrodes electrochemical

2

O : partial pressure electrochemical sensor

2

NO: 0 – 100 ppm (upgradeable on request) (ONLY for

NOXtec 1000)
Measuring range
NO : 0 – 20 ppm
2

O : 0 – 100 %
2

NO: ± 5 %

Measurement accuracy NO : ± 10 %
2

O : ± 3,5 %
2

NO: 0.1 ppm

Resolution NO : 0.1 ppm

2

O : 0.1 %
2

NO: < 10 s

Response time NO : < 40 s

2

O : < 20 s
2

Sampling line flow setpoint 90 – 200 mL/min (± 7 %)

Rev. 20En – 10/2019 65

 NOXTEC: USER MANUAL

Calibration cylinder input pressure Minimum 3.5 Bar, nominal 4.5 Bar, maximum 5.5 Bar

Operational life of the sensors 12 months

20.4. Dosing module and User Interface (only for NOXtec 1000 and
2000)

Real time (ONLY for NOXtec 1000)

Automatic (ONLY for NOXtec 1000)

Dosing modes
Semi-automatic (ONLY for NOXtec 1000 and 2000)

Manual (ONLY for NOXtec 1000 and 2000)

Manual dose bypass

Approximated 0 – 0.02 – 0.03 – 0.05 – 0.07 – 0.1 – 0.15 – 0.2 – 0.25
(for NOXtec 1000 and
flow positions – 0.3 – 0.45 – 0.6 L/min (± 30 %)
2000)

Cylinder inlet pressure Minimum 3.5 Bar, nominal 4.5 Bar, maximum 5.5 Bar

Accuracy of dosing ± 10 % (ONLY for NOXtec 1000)

Resolution dose 0.5 ppm

Ventilator flow range 0.5 – 100 L/min (ONLY for NOXtec 1000)

Dosing flow 0 – 4.0 L/min NOXtec 1000 (0 – 1 L/min NOXtec 2000)

Set-up time < 2 min fs

Screen Colour LCD 10.1”

Sound pressure 75 – 85dba at 1 m

20.5. Electrical specifications

100 – 240VAC, 50 – 60 Hz, 2A max

Power supply Internal Lithium battery powered device

Device designed for continuous operation

Fuse 2A, Ø5mm x 20mm, FSF5x20 250V,

Duration >4h
Battery
Charging time <4h

EN 60601-1-2:2015
Normative
EN 60601-1:2008 + A12:2015

Rev. 20En – 10/2019 66

 NOXTEC: USER MANUAL

Classification Class I, Type B

20.6. Electromagnetic and RF specifications

Guidance and manufacturer's declaration - electromagnetic emissions

NOXtec is intended for use in an electromagnetic environment specified below. User of NOXtec should
ensure that it is used in save environment

Emission test Conformity Electromagnetic environment - Guide

NOXtec uses RF energy only for its internal function.

RF emissions Therefore, their RF emissions are very low and are
Group 1
CISPR 11 not likely to cause any interference to nearby
electronic devices
RF emissions
CISPR 11 Class B

Harmonic emissions NOXtec is suitable for use in all establishments,

Class A including domestic environment and those using the
IEC 61000-3-2
public low voltage power supply network that power
Fluctuations of buildings used for domestic purposes.
voltage/flickers emission Comply
IEC 61000-3-3

Rev. 20En – 10/2019 67

 NOXTEC: USER MANUAL

Guidance and manufacturer's declaration – electromagnetic immunity

NOXtec is intended for use in an electromagnetic environment specified below. User of NOXtec should
ensure that it is used in save environment

Immunity test Standard or test Level of conformity

method
±8 kV by contact
Electrostatic discharge (ESD) IEC 61000-4-2
±2 kV, ±4 kV, ±8 kV, ±15 kV by air
3 V/m, 80 MHz – 2.7 GHz, 80% AM at 1
Radiated RF EM fields IEC 61000-4-3
kHz
Proximity fields from RF
wireless. Communication IEC 61000-4-3 See reference in Table below
equipment
Rated power frequency
IEC 61000-4-8 30 A/m, 50Hz or 60 Hz
magnetic fields

Transient/fast bursts IEC 61000-4-4 ±2 kV, 100 kHz repetition frequency

Surges, line to line IEC 61000-4-5 ±0.5 kV, ±1 kV

Surges, line to ground IEC 61000-4-5 ±0.5 kV, ±1 kV, ±2 kV

3 V, 0.15 – 80 MHz
Conducted disturbances IEC 61000-4-6 6V in ISM bands between 0.15 – 80 MHz
induced by RF fields
80% AM at 1 kHz

0 % UT 0.5 cycle at 0˚, 45˚, 90˚, 135˚,

180˚, 225˚, 270˚ and 315˚
Voltage dips IEC 61000-4-11
0 % UT 1 cycle and 70% UT 25/30 cycles.
Singles phase at 0˚

Voltage drops, interruptions

and voltage variations in the IEC 61000-4-11 0 % UT, 150/300 cycle
power input lines

NOTE: UT is the AC voltage supply before the application of the test level.

Interference may occur in the vicinity of devices marked with the following symbol:

Rev. 20En – 10/2019 68

 NOXTEC: USER MANUAL

Recommended distances between portable or mobile RF communications devices and NOXtec

NOXtec is intended for use in an electromagnetic environment in which RF radiations are controlled.
User can help prevent electromagnetic interference by maintaining a minimum distance between
portable or mobile RF communications devices (transmitters) and the NOXtec as recommended
below, according to the maximum output power of the communications devices.

Maximum power Distance according to the frequency of the transmitter

output of the (m)
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
(W) 𝑑𝑑 = 1.17 √𝑃𝑃 𝑑𝑑 = 1.17 √𝑃𝑃 𝑑𝑑 = 2.33 √𝑃𝑃
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.74
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters with a maximum output power not listed above, the recommended distance d in
meters (m) can be determined using the equation applicable to the transmitter frequency, where P
is the maximum power output in watts (W) according to the manufacturer of the transmitter.

NOTE 1: At the frequencies of 80 MHz and 800 MHz, the distance is applied for the highest
frequency range.

NOTE 2: These guidelines cannot be applied in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

Rev. 20En – 10/2019 69

 NOXTEC: USER MANUAL

Specifications for enclosure port immunity to RF wireless communication equipments

Test Immunity
Band Maximum Distance
frequency Service Modulation level
(MHz) power (W) (m)
(MHz) (V/m)
380 - Pulse modulation
385 TETRA 400 1.8 0.3 27
390 18Hz
430 - GMRS 460, FM ± 5kHz
450 2 0.3 28
470 FRS 460 deviation 1kHz sine
710
704 - LTE band 13, Pulse modulation
745 0.2 0.3 9
787 17 217 Hz
780
810 GSM
870 800/900,
800 - TETRA 900, Pulse modulation
2 0.3 28
960 iDEN 820, 18 Hz
930 CDMA 850,
LTE band 5
1720 GSM 1800,
1845 CDMA 1900,
1700 - GSM 1900, Pulse modulation
2 0.3 28
1990 DECT, LTE 217 Hz
1970 band 1, 3, 4,
25, UMTS
Bluetooth,
WLN 802.11
2400 - Pulse modulation
2450 b/g/n, RFID 2 0.3 28
2570 217 Hz
2450, LTE
band 7
5240
5100 - WLN 802.11 Pulse modulation
5500 0.2 0.3 9
5800 a/n 217 Hz
5785

WARNING: Expected service life of the unit will be compromised if the electro-magnetic
environment is not appropriated.

WARNING: The device can show NO and/or NO2 inspected alarm under the effect of
electromagnetic radiation in the ranges of 250-325MHz and 385-450MHz.

Rev. 20En – 10/2019 70

 NOXTEC: USER MANUAL

21. Troubleshooting

Problem Identification Solution(s)

Failure in gases calibration. An error appears at the end - Repeat the calibration
Sometimes it could be of the calibration. The code process
happened that the sampling can indicate in what step the
- Ensure the sensors are not
pump do not recover the failure occur.
obsolete checking in the
correct operation regiment
user interface
or the calibration
parameters are out of - Check the correct
range connection of the calibration
gas and that the cylinder is
open

Low pressure is too high Low pressure out of range - Press the venting button of
alarm the gas channel

Low pressure is too low Low pressure out of range - Check the cylinder is
alarm connected to the device and
opened

Regulated pressure is too Regulated pressure alarm - Press the venting button
high of the cylinder in operation

High pressure too low High pressure out of range - Check the pressure
sensor is connected to the
device
- Check the cylinder is
opened
- Check the sensor and
cylinder are connected to
the same channel

Error in automatic flow Error in the calibration - Repeat the calibration of

controller’s calibration process or flow the flow controller
compensation is out of
range - Check the cylinders are
correctly connected an
opened

When the unit is initiated There is a low-level error - Disconnect the dosing line
and is in the main windows, “Dosing: error in regulated from the inspiratory limb
the regulated pressure is pressure” and open the manual flow
out of range control in position B or C
This happen when gases during few seconds until the
cylinders are open suddently error disappear

Battery error The charge of the battery - Leave the device

appears as very low (less connected to the main
than 10%) during 2h before using it
with patients

Rev. 20En – 10/2019 71

 NOXTEC: USER MANUAL

Low battery error and the The low battery alarm - Unplug the main and plug
device appears like appears it after few seconds
disconnected from the main
The main connection symbol - Check the fuse in the
despite the main cable is
does not appear in top of botton of the main cord
connected
the battery at the right top connector
corner

Leaking in the outlet of the The device is underdosing - Call to the technical
dosing module support for verifying the
When the dosing outlet is
closed with the finder, it is device.
not pressurised after few
seconds

Monitor is measuring the When device start dosing or - Call to the technical
venting gas of the dosing the cylinder is exchange, a support for replacing the
module high concentration of NO is one-way valve of the outlet of
read in the User Interface the monitor module

Device is underdosing When the inlet of the - Leaking in the monitor

watertrap is closed with the module
finger, it is not doing vacuum
- Oneway valve in the outlet
of the monitor is leaking

Measurement of the The wire of the hot wire - Replace the sensor. It is
respiratory flow is not sensor is dusty and must be not possible to clean the
correct after 2 or 3 days clean sensor during treatment

Battery is not charging with Battery is not charged when - This happen in devices of
the device off and plug to device is connected to the 2017 and 2018.
the main main
- Turn the device On for
charging

Battery is fully depleted and The device is on but battery - Send to the battery the
is not charging as expected charge is not increasing and charging command again
the power lid could be not and turn the device off,
reconginsed disconnect from the main
for 2mins and turn it on
again

NOXtec 1000 or NOXtec The device does not detect - Restart the device
2000 turn on with the user the electronic dosing board
interface of NOXtec 3000

Rev. 20En – 10/2019 72

 NOXTEC: USER MANUAL

22. Control of the NO2 concentration

The NO2 is generated due to the chemical reaction between the NO coming from the device
and the O2 in the inspiratory limb coming from the ventilator. The NO2 concentration strongly
depends on the next parameters:

1- NO concentration. The higher the NO concentration is, the higher the NO2
concentration will be.
2- O2 concentration. The higher the O2 concentration is, the higher the NO2
concentration will be.
3- Respiratory flow. The higher the respiratory flow is, the lower the NO2 concentration
will be.
4- Respiratory circuit. The longer the NO gas remains in the respiratory circuit
(including humidifier vessel) the higher the concentration of NO2 will be.

The disposable kit supplied by the manufactured is optimised to achieve as low concentration
of NO2 as possible. Whatever modification the user does in the kit could result in an
increment of the NO2 concentration generated.

In the next table, it is presented a reference of the NO2 concentration generated in different
situations for the user information. If the connection of the respiratory circuit is different to
the description on the disposable kit information, the concentration of NO2 could be
significantly higher.

5 L/min 10 L/min

100% of O 2 21% of O 2 100% of O 2 21% of O 2

NO (ppm)
NO2 NO 2 NO2 NO 2

(ppm) O (%)
2 (ppm) O (%)
2 (ppm) O (%)
2 (ppm) O (%)
2

10 0.2 99.9 0.0 20.9 0.1 99.7 0.0 20.8

40 1.4 95.1 0.6 20.4 0.6 95.6 0.2 19.8

80 1.8 88.1 0.8 19.1 0.8 88.7 0.4 18.8

100 2.0 84.7 1.0 18.5 1.1 84.8 0.6 18.3

Rev. 20En – 10/2019 73

 NOXTEC: USER MANUAL

23. Compatibility with ventilators

NOXtec measures the breathing flow in the inspiratory limb and inject NO/N2 gas to
produce the set NO concentration (ppm). This system makes the device compatible with
most of the ventilators available in the market and their corresponding ventilatory mode by
connecting one of the respiratory flow technologies: differential pressure or hot wire, into the
inspiratory limb of the patient’s breathing circuit.

The list of the most typical ventilator used for NO is presented below. Note that the use of the
device in anaesthesia machine is described as to be confirmed (TBC) because the connection
of the dosing and monitoring device in the anaesthesia circuit could require of a special
disposable kit.

Ventilator list

High
Manufacturer Model Neonatal Paediatric Adult Transport Anaesthesia
Frequency

Acutronics Fabian •
Medical
Systems AG Fabian HFO • •
Bio-Med Crossvent •
devices MVP-10 •
Bird VIP • • •
Bunnell Life Pulse •
Carefusion Revel • • • •
Apollo TBC
Babylog
8000, •
Babylog 8000
plus • •
Draeger Evita XL • • •
Babylog
VN500 • •
Evita Infinity
V500 • • •
Zeus TBC
Aespire
7100/7900 TBC
Aestiva TBC
GE Healthcare Avance TBC
Centiva/5 • •
Engstrom
Carestation • • •
C1/C2 • • •
Hamilton
G5 • • •

Rev. 20En – 10/2019 74

 NOXTEC: USER MANUAL

Galileo • • •
S1 • • •
T1 •
Heinen &
Lowensten
Leoni+ • •
Infant Star
950 • •
Infant Start
Infrasonics
100 •
Intant Start
500/950 •
Humming
Metran
HMX • •
Servo 300 • •
Servo-i • • •
Maquet Servo-n •
Servo-s • •
Servo-U • • •
E360 • • •
Newport HT50 • •
Wave • • •
Pulmonetic LTV
system 1000/1200 • •
7200 • •
Puritan
Bennett
840 • • •
980 • • •
Respironic Esprit • • •
3100A •
Sensormedics
3100B •
SLE 5000 • •
SLE life support
SLE 6000 • •
BabyPAC 100 •
Smiths Medical VentiPAC
200D •
Sophie • •
Stephan
Stephanie • • •
Avea • • •
Viasys
Vela • • •

Rev. 20En – 10/2019 75