User’s Manual

LIFE 400 FUTURA DEFIBRILLATOR

MAN00001_04

CMOS DRAKE DO NORDESTE S.A

AV. REGENT, 600, SALA 205; TERREO E 1º ANDAR
B. ALPHAVILLE, LAGOA DOS INGLESES
NOVA LIMA – MG – CEP: 34,018-000 – (0XX31) 3547-3969
TECHNICAL HEAD: BÁRBARA HELEN SOUZA MAIA
CREA/MG: MG 224055-D
LEGAL REPRESENTATIVE: MARCO AURÉLIO MARQUES FÉLIX

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ATTENTION!
CMOS DRAKE is exempt from any and all liability for personal or material damage caused
by incorrect use of the AED LIFE 400 FUTURA and its accessories. The following situations
are considered incorrect use:

Use outside the recommendations, information and warnings of the User’s Manual.
Application other than the intended purpose.
Breakage of the security seal, which characterizes loss of warranty.
Interventions, repairs or changes to the equipment outside the authorized network.
Use of defective accessories or components, beyond the expiration date or not
supplied by the Manufacturer;
Equipment operation by unqualified person.

Only use the battery and charger supplied by the Manufacturer or its authorized agents,
otherwise there may be a risk of explosion.

For more information on warranty or technical assistance, contact CMOS DRAKE

technical support.

Copyright © 2017 Cmos Drake. AED Life 400 Futura and Cmos Drake are registered trademarks of
Cmos Drake do Nordeste LTDA. The software of this product is the intellectual property of Cmos
Drake protected by international copyright laws. The software is provided exclusively for use with
the accompanying device and cannot be analyzed, modified or reproduced in part or in full.

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Congratulations on your purchase of the Life 400 Futura
Defibrillator from CMOS DRAKE. This product
incorporates state-of-the-art electrocardiogram monitoring
technology to automatically identify cardiac arrhythmias
that require early defibrillation.

All the information necessary for the safe and correct use
of the Life 400 Futura Defibrillator can be found in this
manual, in addition to information on essential care,
conservation, clarifications related to Technical
Assistance and the Warranty Certificate.

The complete reading of this manual must precede before

using the equipment, as it is a mandatory and essential
condition. Always keep the manual close to the equipment
for consultation, doubts and clarifications.

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TABLE OF CONTENTS

1 ACRONYMS 8
2 TERMINOLOGY 9
3 SYMBOLS 10
4 UNITS 12
5 SAFETY 14
General Warnings 14
Warnings about Electrodes 15
Warnings about Battery and Charger 15
Warning about Watch Dog 16
Warnings about Electromagnetic and Biological Compatibility 16
Warnings about Maintenance 17
Warnings about Areas of Risk 17

6 INTRODUCTION 19
INDICATION FOR USE 19
CONTRAINDICATIONS 20
REGULATORY REQUIREMENTS 21
ITEMS INCLUDED 21
OPTIONAL ITEMS 22

7 INSTRUCTIONS 23
PACKAGING 23
ACCOMMODATING THE EQUIPMENT 23
GUIDELINES FOR USE 24
AFTER USE TIPS 24

8 THE PRODUCT 25
GENERAL FEATURES 25
MAIN PANEL 27
Guidance Icons During Service 29
REAR PANEL 29
BATTERY CHARGER 30
DISPOSABLE ADHESIVE SHOCK PADS 31

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 BLS PROFESSIONAL BAG FOR AED 32

9 BATTERY 34
ABOUT LITHIUM BATTERIES 34
TYPES OF BATTERY 34
BATTERY REPLACEMENT 36
RECHARGABLE BATTERY 38
DISPOSABLE BATTERY 40

10 SELF TEST 41
CORRECTIVE MAINTENANCE 41
PREVENTIVE MAINTENANCE 41

11 MODE OF USE 43
ABOUT DEFIBRILLATION 43
ANALYZER OF HEART RHYTHMS 44
Validation of the Cardiac Rhythm Analyzer 44
EQUIPMENT DEFIBRILLATION ENERGY 45
SERVICE SEQUENCE 45
STARTING THE EQUIPMENT 46
EQUIPMENT USE SEQUENCE 47
TURNING OFF THE EQUIPMENT 50

12 OPTIONAL 51
MEDICAL MODE 51
Sequence of Use of the Medical Mode (Manual Mode) 51
PULSE OXIMETRY 52
Sensor Operation 52
Factors That Compromise SpO2 Reading 52
Characteristics 53
Use of the Clip Type Sensor 54
Use of the Y Type Sensor 54
Warnings for Choice of Sensor 55
Sequence of Use of the Oximetry Mode 55
3-WAY ECG MONITORING 57
Sequence of Use of the Monitoring Mode 58
CPR FEEDBACK DEVICE 60
CPR Feedback Device Operating Parameters 61
Sequence of Use of the CPR Feedback Device 62
Visual depth indicator 65
Display Icons for Guidance During Service 66

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 EMERGENCY CABIN 67

13 MANAGING DATA 68
DESCRIPTION 68
INSTALLATION OF THE DATA RECORDING SOFTWARE 68
Minimum Requirements 68
Installation Procedures 68
OPERATING THE PHOENIX SOFTWARE 72
Downloading AED Data 72
Viewing Stored Data 75
Exporting Service Data 78
Printing Files 80
Copying Phoenix Content 80
Changing Language 81
Switching Page 81
Enlarging or Reducing the Screen 81
Obtaining Information about Phoenix 82

14 MAINTENANCE 83
PRECAUTIONS AND SPECIAL CARES 83
CLEANING OF EQUIPMENT AND ACCESSORIES 84
Cleaning of the Equipment 84
Cleaning of the Accessories 85
DISPOSAL OF EQUIPMENT AND ACCESSORIES 85
Disposal of Equipment at End of Useful Life 85
Battery Disposal 85
Disposal of Accessories 86
PREVENTIVE INSPECTIONS 86
Preventive Maintenances 87
Programming of Tests and Maintenance 87
Equipment Calibration 89
TROUBLESHOOTING 91
ADVERSE EFFECTS 92

15 APPENDIX A 93
LIST OF BASIC ACCESSORIES 93
LIST OF OPTIONAL ACCESSORIES 95

16 APPENDIX B 98
EQUIPMENT TECHNICAL SPECIFICATIONS 98
Compliance with Standards and Certifications 98
General Specifications 98
Operation Specifications 98
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 Transitory Operation Specifications 99
Storage and Transport Specifications 99
Safety Specifications 99
Internal Battery Specifications 100
Battery Charger Specifications 102
Defibrillation Specifications 103
Oximetry Specifications 104
ECG Specifications 105
Feedback Device Specifications for CPR 106

17 APPENDIX C 107
APPLIED TECHNOLOGY 107
Heart Rhythm Detector 107
Recording Methods 107
Rhythm Selection Criteria 107
Annotation Methods 107
Detector Performance Assessment Method 108
Shock Application as a Function of Impedance 108
Truncated Exponential Biphasic Waveform 108
Variations According to the Patient's Thoracic Impedance 109

18 APPENDIX D 110
ELECTROMAGNETIC EMISSIONS 110

19 TECHNICAL ASSISTANCE 111

20 TECHNICAL ASSISTANCE 111
21 REGISTRATION FORM 111
22 REGISTRATION FORM 111
23 MAINTENANCE CHECKLIST 111
24 MAINTENANCE CHECKLIST 111
25 CERTIFICATE OF WARRANTY 111
26 CERTIFICATE OF WARRANTY 111

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 ACRONYMS

ACLS Advanced Cardiology Life Support;

AHA American Heart Association
BLS Basic Life Support
CoHb Carboxyhemoglobin
DEA Automatic External Defibrillator
ECG Electrocardiogram
ERC European Resuscitation Council
VF Ventricular Fibrillation
MetHb Metahemoglobin
CRA Cardiorespiratory Arrest
SCA Sudden Cardiac Arrest
PPM Pulses per minute
CPR Cardiopulmonary Resuscitation
SpO2 Oxygen Saturation
VT Ventricular Tachycardia
PVT Pulseless Ventricular Tachycardia
ICU Intensive Care Unit

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 TERMINOLOGY

Watch Dog Electronic device that resets the system when an error condition is
identified.
Software A program recorded in an electronic device that determines how it
functions.
Hardware The physical part of a device that contains the interconnected
electronic circuits and components.
Equipment It refers to the Life 400 Futura Defibrillator.
Service Period in which the Equipment is in operation connected to an
individual.
Patient Individual who presents CRA and/or is under the Equipment’s Service.
Operator Person duly qualified to perform BLS/ACLS and to use Automatic
External Defibrillators and who is operating the Equipment during a
Service.

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 SYMBOLS

Figure Relevant Standard Description

IEC 60878 - 5036 Hazardous Electric Potential Difference (Voltage)

IEC 60878 - 5031 Direct Current

~ IEC 60878 - 5032 Alternating Current

IEC 60878 - 5172 Class II Equipment

IEC 60878 - 5036 Attention!

IEC 60601-1 It refers to the instructions manual

IEC 60878
Do not sit
Safety 35

IEC 60878
Do not step on the surface
Safety 37

IEC 60878 - 5010 On/Off Key

N/A Shock trigger button for treatment

N/A Low battery indicator

N/A AED Battery Charger Polarity

N/A Heartbeat indicator on equipment display

IEC 60878 - 5336 Defibrillator-proof CF type applied part

IEC 60878 - 5334 Defibrillator-proof BF type applied part

This side up: indicates the correct position in which the

ISO 780
box should be transported
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 Fragile: indicates that the package must be transported
ISO 780
and handled with care

Keep dry: indicates that the package should be kept in a

ISO 780
dry place

Number 5: indicates the maximum stacking of five

ISO 780
overlapping units

IEC 60878 - 0632 Minimum and maximum temperature

ISO 7000 / IEC

Minimum and maximum humidity
60417

ISO 7000 / IEC

Minimum and maximum pressure
60417

It indicates that it is a medical equipment and, therefore,

N/A
it deserves special handling

EN 980 Manufacturer

IEC TR 60878 It indicates that it is composed of recyclable raw material

Directive Wastes from electric and electronic equipment - Disposal

2002/96/CE separated from other objects

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UNITS

Type Unit Name Equivalence

ms Millisecond 10-3 s
s Second 1s
Time
m Minute 60 s
h Hour 3600 s
Hz Hertz 1 Hz
kHz Kilohertz 103 Hz
MHz Megahertz 106 Hz
GHz Gigahertz 109 Hz
Frequency
bps Beat per Second 1 bps
rpm Respiration per Minute 1 rpm
bpm Beat per Minute 1 bpm
ppm Pulses per Minute 1 ppm
mm Millimeter 10-3 m
Length cm Centimeter 10-2 m
m Meter 1m
mm2 Square Millimeter 10-6 m2
Area cm2 Square Centimeter 10-4 m2
m2 Square Meter 1 m2
dL Deciliter 10-2 L
L Liter 1L
Volume
mm3 Cubic Millimeter 10-9 m3
m3 Cubic Meter 1 m3
mm/s Millimeter per Second 10-3 m/s
Speed
m/s Meter per Second 1 m/s
L/s Liter per Second 1 L/s
Flow
L/m Liter per Minute 60 L/s
g Gram 1g
Mass
kg Kilogram 103 g
mmHg Millimeter of Mercury 133.3 Pa
Pressure hPa Hectopascal 102 Pa
Pa Pascal 1 Pa
°F Degree Fahrenheit (1 °C – 32) 5/9
Temperature
°C Degree Celsius 1 °C
Resolution px Pixel N/A
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 Ω Ohm 1Ω
Impedance
MΩ Megaohm 109 Ω
mV Millivolt 10-3 V
Electric Potential
V Volt 1V
Difference / Voltage
kV Kilovolt 103 V
µA Microampere 10-6 A
Current mA Milliampere 10-3 A
A Ampere 1A
Current Density A/m Ampere per meter 1 A/M
C Coulomb 1C
Electric Charge
mAh Milliampere-hour 3.6 C
Power W Watt 1W
Energy J Joule 1J
Intensity dB Decibel 1 dB
B Byte 1B
Digital Storage MB Megabyte 106 B
GB Gigabyte 109 B

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 SAFETY

General Warnings
Equipment maintenance must be performed exclusively by the Manufacturer or Authorized
Technical Assistance, otherwise, the technical assistance warranty is interrupted and the
equipment owner becomes solely responsible for possible physical, material and other
damages.

Only use the equipment on one patient at a time.

Do not use the AED close to other equipment. If this occurs, it may affect the correct
functioning of the equipment. Always check its functionality if this instruction is not
followed.

Do not connect other equipment to the patient at once.

The equipment must be used by people duly trained in Basic Life Support or Advanced
Life Support (BLS/ACLS).

The reading of this Manual does not in any way override the training of people in BLS/ACLS
who will make use of the equipment.

The operator must check the condition of the equipment and its accessories (frequent and
regular checks), especially regarding the validity of disposable electrodes and the battery
charge level.

Keep the equipment stowed in its transport bag or in the Emergency Cabin (if it has),
ensuring the integrity of the equipment.

When installing the equipment with the battery charger, make sure they are in a place with
enough space for ventilation and away from heat radiation.

The equipment was developed to identify, through electrocardiogram monitoring,

arrhythmias that require defibrillation (which require defibrillation) in patients who are
victims of cardiorespiratory arrest. It can be used inside or outside the hospital
environment, including rescue units, promoting life support.

The equipment must not be used adjacent to or on top of other equipment. Such a
configuration may lead to improper operation.
Obs.: If use becomes necessary, it is advisable that the equipment involved be observed
to certify their correct functioning.

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Warnings about Electrodes

Prevent disposable electrodes (shock pads) from coming into contact with each other
(short circuit).

Move ECG electrodes, bandages or any other metallic objects away from the disposable
electrodes due to the risk of the patient suffering skin burns during defibrillation, an effect
caused by deviation of the current to the heart.

Do not touch the patient, electrodes or any conductive material during ECG analysis as
the result of ECG interpretation will be affected.

At the moment of shock, never touch the patient. Keep away from it.

During defibrillation, burns to the patient's skin may occur if there are air pockets between
the skin and the pads. To prevent this from happening, make sure the pads are completely
adhered to the skin. Use the pads within the expiration date recorded on the packaging,
and only once.

Only open the package containing the disposable electrodes when using it on the patient.
Once opened, use it or discard it.

Do not touch the patient, beds (stretcher), equipment or any accessory connected to the
patient during defibrillation.

The patient should not have contact with metallic objects and/or conductive fluids, as this
is capable of causing unintended currents through accessory pathways.

The electrodes may remain connected to the patient for up to 6 (six) hours, for ideal skin
conditions (intact, without injuries, irritations, among others).

When using this equipment, disconnect other devices from the patient, as the high voltage
of the electric shock can cause damage to them.

Warnings about Battery and Charger

When using the AED, immediately disconnect the battery charger from it.

Never use batteries not supplied by the Manufacturer and/or non-serial batteries. Cmos
Drake is not responsible for damages caused by the use of batteries from unauthorized
third parties, since they can cause several and serious damages, such as: non-functioning
of the equipment, burning, loss of performance, incorrect indication of the battery level.
and explosion risk.

The equipment does not start up with the battery charger connected to it.

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 Never use another battery charger that is not always the original supplied by Cmos Drake,
as several and serious damages can occur, such as burning the equipment, incorrect
operation, damage to the battery and risk of explosion.

Do not place the battery charger connected to extensions or additional MULTIPLE

OUTLETS directly on the floor, in such a way as to prevent the ingress of liquids into the
contacts and prevent electrical and mechanical damage.

Disposal of batteries must follow Environmental regulations. Consult your city’s

Environment Department.

Keep the battery away from fire and other heat sources and avoid dropping it when the
battery is taken out for end-of-life disposal.

Do not place the battery near metallic objects that could cause a short circuit.

Never disassemble, puncture, crush or open the battery. Respect the safety circuit. Risk
of explosion.

Warning about Watch Dog

The equipment has a Watch Dog circuit designed to activate the system reset if any
unexpected error condition occurs, resetting the equipment. The Watch Dog circuit
(hardware reset) is an additional security system that exists in any electronic device that
uses embedded software.

The Watch Dog circuit is used to reset the main board circuit, without the need for operator
intervention, in case the crash occurs due to external reasons.

The Watch Dog circuit during normal equipment operation is in Standby. Therefore, it has
no active function on the equipment. It only comes into operation if the main board circuit
crashes.

The Watch Dog circuit does not pose a risk to the patient and the user, does not influence
stability and does not affect the performance of the product.

Warnings about Electromagnetic and Biological Compatibility

Avoid using a cell phone or any devices that pick up radio frequency near the equipment.
The high level of electromagnetic radiation emitted by these devices can result in
interference, impairing the normal functioning of the defibrillator, putting patient safety at
risk.

In general, the EQUIPMENT Parts and ACCESSORIES of the Life 400 FUTURA Defibrillator
intended to come into contact with biological tissues, cells or body fluids are tested and
analyzed in accordance with the guidelines and principles of ISO 10993-1, which deals
exclusively with testing of biocompatibility of the applied parts.

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 On Aircrafts / Ambulances / Vehicles in General:
- Low level of radiation from electromagnetic fields.
- High immunity to transients and external electromagnetic fields.
- High mechanical resistance to vibration.

Portable RF communications equipment (including peripherals such as antenna cables

and external antennas) is not recommended to be used within 30 cm of any part of the AED
or its accessories (including cables). Otherwise, performance degradation of this
equipment may occur.

Warnings about Maintenance

Risk of electric shock if the equipment or battery charger cabinet is opened. Any type of
technical service or future updates to the equipment and its parts may only be carried out
by personnel duly trained and authorized by Cmos Drake.

Disposable materials must not be reused. They must be disposed of in appropriate places
according to the special procedures for hospital wastes.

If any part of the equipment, battery, battery charger and disposable materials need to be
replaced, contact the manufacturer or the authorized network to supply the material and
replace it, when necessary. If accessories from suppliers other than those indicated by
Cmos Drake are used, the company is not responsible for the operation of the equipment
and will have its warranty nullified.

There is a risk of polluting the environment associated with the use of accessories and
consumables at the end of their useful life. Accessories and consumables must be
disposed of in hospital wastes in accordance with environmental law. Batteries must be
delivered to appropriate environment or returned to the manufacturer or an appropriate
collection center after replacement due to a defect or end of life.

No modifications to this equipment and its parts are permitted.

Warnings about Areas of Risk

This equipment is not designed to operate in environments containing flammable

anesthetics and cleaning agents. Do not use it in the presence of flammable gases.

To prevent the risk of fire or undue shock, avoid operating or placing the equipment near
water source or flammable products, do not leave liquid products on the cabinet and/or
battery charger.

Risk of explosion if the equipment and battery charger are used in the presence of
flammable anesthetic gases.

Do not use the Life 400 Futura Defibrillator in areas where there is a risk of explosion.

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Do not use the Life 400 Futura Defibrillator inside x-ray and MRI rooms.

The Life 400 Futura Defibrillator does not have intentional electromagnetic interference.

The equipment must be stored in a ventilated place and free from moisture, dust, light
(including sunlight) and fibers from other materials such as cotton. The mentioned
components can interfere with the correct use or even lead to a total impairment of the
equipment's functioning.

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 1
INTRODUCTION

The AED Automated External Defibrillator, model Life 400 Futura, is an electronic, compact,
lightweight and portable device. This product incorporates state-of-the-art technology aimed
at monitoring the electrocardiogram, to automatically identify cardiac arrhythmias that
require early defibrillation in victims of cardiac arrest, in order to effectively and accurately
combat sudden death.

The equipment is capable of delivering controlled electric shocks that are applied to the
patient's chest using defibrillation electrodes (Disposable Adhesive Pads) with instructions
to the rescuer by voice commands, text and icons (self-explanatory).

The equipment has microprocessed circuits that perform cardiac mapping and automatically
identify shockable cardiac arrhythmias such as PVT – Pulseless Ventricular Tachycardia and
VF – Ventricular Fibrillation.

The equipment can be used in adult and child patients, in different places and environments,
allowing basic life support in this first care, considerably increasing the survival rate.

INDICATION FOR USE

The Life 400 Futura Defibrillator has the basic function of automatically identifying
cardiac arrhythmias to revert to sinus rhythm.
The equipment can be used by the lay public (trained in BLS - Basic Life Support and
medical professionals trained in ACLS). The equipment operates automatically,
regardless of the operator's prior knowledge of cardiac arrhythmias.
The equipment has voice commands, text, intuitive icons on the display and an
audible beep, to guide the rescuer during the care procedure for victims of
cardiorespiratory arrest.
The AED is medically indicated for defibrillation of cardiac arrhythmias susceptible to
shock (Ventricular Tachycardia and Ventricular Fibrillation). The equipment has voice
and text commands that guide the operator through the patient resuscitation
procedure. To use the AED just connect the equipment and follow the instructions.
The AED has the patient population for indicated use:
- Adults and Children, requiring the attention of rescuers as to the type of accessory
to be used in each type of patient.
- Patient status: Unconscious patients.
Applied body part:
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 Shock pads are positioned on the patient as follows:
- Adult Patients: Patient's chest (demonstration on p. 31).
- Children patients: One pad on the chest and another pad on the back 31).
The Defibrillator has as intended user profile:
Education: Users fluent in the language configured on the equipment (Portuguese,
English or Spanish).
Knowledge: Basic first aid training.
Experience: People with basic first aid training.
Language comprehension: Comprehension of the language set on the equipment
for quick understanding of the text and voice commands provided by the equipment.
Inadmissible disabilities: Due to standard resuscitation procedure the equipment
cannot be used by blind, deaf and dumb people.

The equipment has as essential performance:

- Perform the correct reading and analysis of the patient's ECG signal;
- Perform shock treatment when user presses the trigger button;
- Proper operation of voice and text commands;
- Proper functioning of all equipment keys;
- Proper functioning of all available accessories.

The equipment may lose one or more functionalities when exposed to out-of-tolerable
interference rates, such as:
- Anomalies on the display;
- Interference in the audio control;
- Interference in electrocardiogram monitoring.

Intended conditions of use:

Use in places such as: stadiums and sports arenas, bus stations, shopping malls and
commercial centers, ports and airports, hotels, temples, trains, subways, planes and
boats, ambulances and air or ground rescue vehicles, police and fire events of any
kind, and a hospital environment, enabling basic and advanced life support.

It is not intended for use in damp sites.

Limits of environmental conditions shown in Appendix B attached to this manual.
Infrequent use - It is intended to carry less than 2500 discharges with a minimum
interval of 30 seconds between discharges.

CONTRAINDICATIONS

This equipment cannot be used in the presence of flammable agents, such as

anesthetic gases, fuels, among others;
This equipment should not be used by laypersons without proper qualification in Basic
Life Support (BLS);
Asynchronous defibrillation is not indicated for patients:
Conscious;
With spontaneous breathing;
With a palpable pulse.

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 This equipment does not indicate shock treatment in asystole. Defibrillation in case
of asystole can inhibit the recovery of natural pacemakers in the heart and reduce
the chance of recovery.
For patients under 8 years of age or weighing less than 25 kg, disposable infant shock
pads must be used. In addition, if it is not possible to position the two paddles on the
patient's chest with a spacing greater than or equal to 4 cm, one should be placed on
the chest and the other on the back. More information in Chapter 6 – Mode of Use.

REGULATORY REQUIREMENTS

This equipment was designed in full compliance with all Standards and Guidelines relevant
to defibrillation electromedical equipment, which are:

ABNT NBR IEC 60601-1 Electromedical equipment

General requirements for basic safety and essential
performance
ABNT NBR IEC 60601-2-4 Electromedical equipment
Specific requirements for basic safety and essential
performance of cardiac defibrillators
ABNT NBR IEC 60601-1-2 Electromedical equipment
General requirements for basic safety and essential
performance -
Collateral standard: Electromagnetic compatibility
ABNT NBR IEC 60601-1-6 Electromedical equipment
General requirements for basic safety and essential
performance -
Collateral standard: Usability

ABNT NBR IEC 60601-1-12 Electromedical equipment

Requirements for medical electrical equipment and
medical electrical systems intended for use in emergency
medical service environments
IEC 62304 Medical device software
Software life cycle processes
Ordinance No. 350/10
INMETRO
Ordinance No. 384/20

ITEMS INCLUDED

1 (one) Life 400 Futura Defibrillator – AED;

1 (one) rechargeable battery or disposable battery;
1 (one) battery charger (if the battery is rechargeable);
1 (one) disposable shock pad (adult);

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 1 (one) USB cable;
One (1) professional yellow BLS bag with compartments for AED and BLS
accessory storage;
1 (one) AED Life 400 Futura warranty certificate;
1 (one) user manual containing:
All information necessary for the use and care of the equipment;
Link/QR code for downloading Phoenix software for device data
acquisition.

OPTIONAL ITEMS

Medical Mode (Manual Mode): Used for shock delivery by the medical
rescuer, when he wants to deliver the shock.
PULSE OXIMETRY: Used for reading Oxygen Saturation (SpO2) in the patient's
blood.
Electrocardiogram Monitoring by 3-Way ECG Cable: Used to
monitor the ECG signal through the 3-Way ECG cable.
CPR Feedback Device: Used to assist the rescuer during CPR, indicating the
frequency and depth of chest compressions, by voice command and graphic
indicator that shows the level of compression depth in real time on the display.
Emergency Cabin: Used to house and protect the equipment and its
accessories on the wall at a predetermined height for easy access in case of an
emergency. It has an audible alarm device when opening the cabin.

The description of each optional accessory is in Chapter 7 – Optional Accessories.

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 2
INSTRUCTIONS

PACKAGING

Upon receipt of the Life 400 Futura Defibrillator, inspect each box for damage to the physical
integrity of the packaging or product and that all required accessories are present. If any
product accessory and/or other requested additional accessory is not present or if there are
damages to the equipment, any accessories is verified, contact Cmos Drake within thirty
(30) days after receiving the product. After 30 (thirty) days of receipt, any claim will be
evaluated by CMOS DRAKE, not guaranteeing the replacement of the product and its
accessories.

If you identify damage to the physical integrity of the package, open it and record the physical
state of the equipment and its accessories in the presence of the carrier. Please forward this
incident immediately with knowledge of the carrier to CMOS DRAKE's customer support
department for appropriate action.

ACCOMMODATING THE EQUIPMENT

Remove the AED from the packaging box.

Read without exemptions this manual, specifically Chapter 4 – Battery, which guides
the correct connection of how to charge the battery.
Immediately connect the battery charger into the AED (with rechargeable battery)
and into the electrical outlet. Make sure that the charger is working.
Keep the AED in a suitable and easily accessible place.
Keep the AED away from equipment that generates strong magnetic fields such as
radiological devices, air conditioning systems and others.
Make sure that the installation location has adequate ventilation and is within the
pressure and temperature ranges indicated in this manual (Appendix B - Technical
Specifications of the Equipment).

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GUIDELINES FOR USE

Read without exemptions this Manual.

This equipment must be used by people trained in BLS or ACLS.
Only use accessories supplied exclusively by the manufacturer.
Follow the voice control instructions, texts and intuitive icons of th equipment.
The Life 400 Futura Defibrillator and its basic and optional accessories will promote
safety if used for the correct purpose and according to the instructions described in
this Manual.
All those who need or wish to use the Life 400 Futura Defibrillator must be trained
through training in basic life support, a course taught by accredited institutions,
companies and/or accredited and accredited medical professionals. Guidance on the
fundamentals of defibrillation, as well as on the indications and contraindications, are
essential for the care of a victim of cardiorespiratory arrest.
It is mandatory to read the user’s manual and comply with the safety rules and
warnings contained therein, especially regarding batteries, electrodes, battery
charger and Technical Assistance.
If the patient's chest is wet, it is recommended that the rescuer dry it before attaching
the electrodes.
It is recommended to keep some auxiliary materials such as surgical scissors, a
disposable razor blade to remove hair from the chest and disposable gloves, in case
they need to be used when there is an accident. The BLS bag has suitable housing
to hold these materials.

In the event of improper use of the equipment, the user, patient or other people will be
subject to the risk of electric shock or may suffer burns, due to the high voltage generated
at the time of the shock.

AFTER USE TIPS

Dispose of the accessories after service in an appropriate place.

Replace the shock pads or any accessories on the AED necessary for the service, to
speed up the next one.
Keep the equipment with the battery charged.
Keep the maintenance and cleaning routine always up to date to preserve the
devices.

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 3
THE PRODUCT

GENERAL FEATURES

Functionalities ECG signal analysis and automatic detection of malignant

arrhythmias (PLVT and VF) that require defibrillation.
ECG monitoring via pads before, during and after the shock.
Pacemaker detection.
Detection of battery conditions (originality and validity) and
record in equipment history.
Detection of conditions of the disposable pads (originality
and validity) and record in equipment’s history.
Patient’s thoracic impedance analysis for automatic
adjustment of timing and electrical current of the shock,
increasing defibrillation effectiveness and reducing the risk
of causing heart damage.
Text and voice commands for guidance to the rescuer
during service.

Defibrillation Truncated exponential biphasic waveform.

Automatically limited energy protocol for adult or child
patient, depending on shock pads inserted.
Various power protocols provided at the user's discretion,
up to a limit of 360 J (Joules). By default there are 150J
shots in Adult Mode and 50J in Kid Mode.
Automatic internal discharge after 30 seconds if there is no
trigger.
Charge time adjustable up to 4 seconds for 150 J and 5
seconds for 200 J.

Battery Capacity to perform up to 200 discharges or 10 hours of

monitoring with 2850mAh rechargeable battery at full
charge (new battery with full charge). Optional 300
discharges or 15 hours of monitoring with 3500mAh
rechargeable or disposable battery.
Battery status at various levels clearly visualized on the
display (bar graph).
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 Low battery indicator – audible and visual.
Possibility of using rechargeable or disposable battery.
Battery charger included for rechargeable batteries.
The user himself can easily replace the battery (without the
use of tools), and it is not mandatory to send the equipment
to the manufacturer.

Recording of Dedicated software compatible with Windows environment

Events for communication, recording and interpretation of collected
data to PC, with interface cable.
The equipment recognizes and records the status of the
battery and disposable pads, such as: validity and originality
of accessories.
The equipment identifies its opening by third parties and
records the events in the equipment's memory.
Recording of events and service curves in 4GB continuous
memory that provides more than 200 years of recording,
with visualization and data transfer to computer via USB
connection.

General ECG with beep.

Beep for guidance of the rate of compressions during CPR.
Shock counter, CPR time and clock.
Daily self test.

Cabinet Ingress protection IP 56.

High compression, electrically insulated ABS cabinet.
Handle for transport integrated into the cabinet that
facilitates handling and generates convenience in
transport, preventing accidental falls.

Language Standard: Portuguese.

Optional: English and Spanish.

Monitor Electroluminescent liquid crystal monitor, with real-time

ECG tracing visualization.
Intuitive icons on the monitor to assist the service.

Option features Medical Mode (Manual Mode).

Pulse Oximetry.
Monitoring by 3-Way ECG Cable.
CPR Feedback Device
Emergency Cabin

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MAIN PANEL

1
2

3 4

6
5

Connector of the shock pads

Monitor:
(electrodes) and CPR Feedback
It shows the duration of the service,
1 Device. 2 ECG trace, text commands to the
user according to voice commands.

Treatment button:
Used to trigger the shock. When
3 Weak battery indicator. 4 flashing, it confirms that the shock
is ready to be applied on the patient.

5 Carrying handle. 6 On / Off Button.

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GRAPHIC DISPLAY

1 Text command. 2 ECG Curve.

1 2
SpO2 (%) level indicator in the blood
3 Oximetry curve (Optional). 4
1 2 (Optional).
3 4
1 Icons of measurements to be taken 2 Icon that indicates the type of
5 by the operator. 6 patient (adult or child).
3 4
1 2
5 6
3 Indicator of the patient’s beats per 4 2-minute countdown timer for CPR
1
7 2
8
5 minute. 6 delivery.
3 4
1
7 2
8
5 Count of shocks applied during the 6
3
9 4
10 Battery level icon.
1
7 service. 2
8
5 6
3
9 4
10
7 Timer that indicates the duration of 8
5
11 6
3
9 the service. 4
10
7 8
5
11 6
9 10
7 8
5
11 6
9 10
7 8
11
9 10
7 8
11
9 10
11
9 10
11

11

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Guidance Icons During Service

Place the Electrodes on the If there is no circulation,

Patient. perform CPR for 2 min.

Move away from the Patient.

REAR PANEL

Charger input for rechargeable

1 2 USB output.
battery.

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BATTERY CHARGER

Connection at the back of the

1 Connection to the electric mains. 2 equipment.
Label with the charger's technical
3 specifications and safety 4 Battery charge indicator light.
information.

Never use a battery charger not supplied by the manufacturer, there may be a risk of
equipment explosion.

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DISPOSABLE ADHESIVE SHOCK PADS

Batch and expiry date of the pads

1 2 Instructions for use.
(year/month).

3 Warnings. 4 AED input connector

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 5 Apex Electrode. 6 Sternum Electrode.

The disposable adhesive shock pads are for single use and have a 24-month unopened
packaging warranty and a 24-month post-billing shelf life.

The disposable adhesive shock pads have a maximum time of use of 8 hours in the same
service. After this interval, the pads must be replaced.

The defibrillator has a disposable pad condition detection system (originality and validity)
and record in equipment’s history.

BLS PROFESSIONAL BAG FOR AED

The BLS Professional Bag is made of Cordura (400), a long-lasting material that is resistant
to abrasion, cuts and tears. Cordura is a material with greater resistance compared to nylon,
as its weave is tighter than the weft of polyester, in addition to not forming balls and
presenting very high resistance to abrasion, tearing and perforation. It Is very light, easy to
wash and dries quickly, doesn't mildew and looks like new for a long time.

The bag receives PVC resin to make it more full-bodied\, in addition to an antibacterial and
water repellency. This helps protect your accessories. It features reinforced rubber details
and resistant carrying handles. Coated with strategic electroluminescent reflective dots for
easy viewing of the bag over long distances.

1 Hand carrying handle. 2 Electroluminescent fabric.

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 Compartment for accessories
3 4 Compartment for the AED.
(Left and Right side).

Transparent cover for viewing the Support for adjustable shoulder

5 low battery alarm. 6 strap.

Several compartments to house

7 the materials used in BLS

Keep the equipment stowed in its carrying bag or in the optional Emergency Cabin to
prevent damage and increase its durability.

SERIAL NUMBER
The Serial Number, identification located at the bottom of the equipment, is composed of the following
sequence:
XX XX XX XXXX
1 2 3 4

1: Formed by one or two numbers, it represents the equipment identifier;

2: Formed by two numbers, they represent the YEAR of manufacture of the equipment;
3: Formed by two numbers, they represent the MONTH of manufacture of the equipment;
4: Serial number, sequence formed by four numbers, from 0001 to 9999.

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 4
BATTERY

ABOUT LITHIUM BATTERIES

The batteries used in the equipment have lithium as a base element, as they have a higher
energy capacity, are lighter and do not become addicted like standard nickel-cadmium
batteries. Still, the lithium-based battery requires care to increase its lifespan.
The AED defibrillator has a battery status monitoring system
Identified if it is original and if it is within the validity of use, and when necessary, recording
this data in the equipment history.

It is recommended that these batteries be stored and operated in a cool place, as extreme
temperatures (high or low) accelerate the aging process and battery charge loss. In addition,
the ideal is to keep lithium batteries always charged, as when the battery is fully charged, it
can lose its ability to hold a charge.

TYPES OF BATTERY

The Life 400 Futura Defibrillator is, by factory default, supplied with the Lithium-Ion Standard
2850mAh battery. However, any of the battery options can be supplied as per customer's
request.

Disposable battery option:

Lithium-Manganese Battery: 3500 mAh battery, 5 years standby life, up to 15 hours

of monitoring capacity or up to 300 shocks on a full charge.

Rechargeable battery options:

Standard Lithium-Ion Battery: 2850 mAh battery, 5 years standby life, up to 10

hours of monitoring capacity or up to 200 shocks on a full charge.
Lithium-Ion Plus Battery: 3500 mAh battery, 5 years standby life, up to 15 hours of
monitoring capacity or up to 300 shocks on a full charge.
Lithium-Polymer Battery: 2200 mAh battery, 5 years standby life, up to 5 hours of
monitoring capacity or up to 140 shocks on a full charge.

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Every product purchased with a rechargeable battery is accompanied by the appropriate
battery charger. To obtain the monitoring time or the number of charges described, the
battery must be fully charged (new battery with full charge).

When the low battery indicator is activated, the battery at this very moment still has the
capacity to perform, by factory default, 15 shocks or 30 minutes of monitoring. The amount
of shocks or residual monitoring time after low battery alert can be optionally changed at the
user's discretion to higher or lower values.

The battery has a 12 month warranty after its billing. If the battery is damaged due to
improper use or deviating from the instructions described in this manual, the loss of
warranty will be occur.

Do not disassemble or dispose of in fire, as there is also a risk of explosion.

Never use batteries or battery charger that are not supplied by the Manufacturer.

If the battery shows a loss of performance, immediately contact the nearest Cmos Drake
or Authorized Service Center for immediate replacement.

When the battery is discharged, the battery charger is not able to power the AED.

Do not short-circuit the battery.

Do not allow the battery to discharge completely.

Do not compress or disassemble the battery.

When using loads with the infant electrode (50 Joules) the amount of shocks will be
proportionally higher.

There is loss of battery charge due to execution of the self test (decreasing the battery’s
useful life).

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BATTERY REPLACEMENT

The user must request from the manufacturer or Authorized Technical Assistance the supply
of a new battery for the due replacement at the end of its useful life or defect. The user can
replace the battery himself, and it is not mandatory to send the equipment to the
manufacturer, as it is a removable battery and the replacement time is less than 10 seconds.
If you prefer the equipment, you can send it to the nearest Authorized Technical Assistance
to replace the battery together with a check of the charging circuit and charger.

Whenever the battery is supplied by the manufacturer and/or authorized, check the
authenticity through the serial number, as shown below.

To remove the battery, follow the steps described below.

1 Turn off the equipment.

3
2 Position the equipment with its lower part upwards as shown below.
3
1
3
1
3
1
3
1
3
1
3
1

Push the lock into the indicated position and lift the batttery pack to be replaced
3 as shown below.
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 Position he new battery as indicated below and press downwards until a click is
4 heard.
1

Turn on the equipment and wait for the voice and text commands up to the
phrase:
5 Place the electrodes on the chest of the equipment. Observe the status of the
1 battery charge through the battery level indicator on the display (bar graph).

6 Turn off the equipment.

1
1 If the battery is rechargeable, check the charger's operation and keep it
1 connected to the electrical network and to the equipment until the use of the AED
7
1 is necessary.
1
1
1
1 Very low level batteries can prevent the equipment from turning on. In this case, for
1 rechargeable batteries, connect the equipment to the charger, wait for 4 hours and repeat
1 the test procedure. If the problem persists, contact the Authorized Technical Assistance.
1
1
1
1
1
1
1
1
1
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RECHARGABLE BATTERY

The battery charger is intended for the exclusive use of the Life 400 Futura Defibrillator.

Connect the battery charger to the equipment's rear panel as shown in the figure
below. Note the position of the connector when attaching it. You will hear a click
1 indicating secure connection when the position is correct. Do not force the
1 connector as it may break.

Keep the rear of the equipment a minimum distance of 20 cm from any other
2 device or from the wall, so that you do not run the risk of the battery charger plug
being pressed or disconnected from the equipment.
1

3 Charging time for a fully depleted battery is approximately:

1
Initial charge: 4 hours.
1
Other charges: 1 hour to 4 hours depending on battery status.
1

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1
4 The battery charger has a bicolor LED that indicates charging status:

1 Blue LED: Battery Charging.

1 Green LED: Battery Charged.
1

The rechargeable battery is already fully charged at the factory. When you receive the
equipment, remove it from the packaging and connect the battery charger to keep the
battery fully charged. If the battery is not connected to the battery charger within 60 days
after receipt, there will be a loss of performance, compromising the charging capacity,
resulting in the loss of the battery's warranty.

Do not connect the battery charger to MULTIPLE OUTLETS close to the floor, to prevent
liquids from penetrating the power contacts and prevent electrical and mechanical
damage.

The battery charger of the Life 400 FUTURA Defibrillator is intelligent and automatically
monitors the recharge, being able to remain connected to the electrical network 24 hours,
without having to disconnect the AED from the battery charger.

The equipment will not work for treatment while connected to the battery charger. This
equipment is ready to run on battery power only. Disconnect the battery charger from the
AED to begin use. When turning on the equipment with the charger connected, the
message will appear on the screen: "FOR USE, DISCONNECT THE CHARGER FROM THE
EQUIPMENT!".

It is recommended to replace the AED's rechargeable battery every 2 years, or when the
battery life is less than 1 hour.

In the event of heavy rain and thunder and lightning storms, unplug the battery charger
from the electrical outlet and the AED.

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DISPOSABLE BATTERY

The disposable battery must be replaced when the equipment emits an audible (beep) and
visual signal of a low battery and/or need for maintenance. For more information on alarm
frequency see Chapter 5.

When the low battery indicator is activated, the battery at this very moment still has the
capacity to perform, by factory default, 15 shocks or 30 minutes of monitoring. The amount
of shocks or residual monitoring time after low battery alert can be optionally changed at the
user's discretion to higher or lower values.

The device with a disposable battery performs a count of delivered shocks to show the level
in the battery icon. When replacing the disposable battery with a new battery, it is necessary
to perform the following steps below:

1 Turn on the equipment.

1 Press the treatment button for 5 seconds and wait for the text message “Battery
2 replaced” on the equipment display. After this procedure, the AED can be used.
1
3
Disposable batteries have the capacity to deliver 300 shocks or monitor for 15 hours at full
1 charge. Considering the fact that during the care of a patient in cardiac arrest, defibrillation
3 is often indicated, it is inferred that in a care the disposable battery will be used up to
1 perform the defibrillation and to monitor the patient during the care procedures. Assuming
3 that a service lasts an average of 20 minutes and that 3 shocks will be triggered, disposable
1 batteries significantly lose their charge. We recommend replacing the disposable battery
3 with each service performed for total safety of the next use, since it is not possible to
1 predict the time that the next service will demand as well as the number of shots.
3
1 When the low battery indicator comes on, replace the disposable battery immediately.
3

3
The disposable battery loses its capacity even when not used. We recommend periodically
checking the device's battery level indicator.

Do not disassemble the battery or dispose of it in fire, as there is also a risk of explosion.

The AED has a clock powered by an independent internal battery – model CR 2032 3V –
which must be replaced every 4 to 5 years. This exchange must be carried out at the factory
or at an authorized technical service. After depleting this battery, the AED loses the ability
to record the date and time of services.

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 5
SELF TEST

The Life 400 Futura Defibrillator performs self-tests, informing the AED status to the user.
In this way, the user is always aware of the need to maintain the equipment, preventing it

7
from being unloaded or defective during an emergency.

Even if the Equipment has a self-test capability, it is recommended that the User always
keep the Equipment charged and carry out periodic checks of the battery status and its
functioning.

CORRECTIVE MAINTENANCE
The equipment has a routine to check the need for maintenance. If a problem is identified,
the system alerts the operator by text message and voice command as follows:

Message Necessary Action

“Needs Maintenance Recharge or replace the
Low battery” battery.

7
Restart the system. If the
“Needs Maintenance problem persists, contact the
Hardware Failure” Authorized Technical
Assistance.

PREVENTIVE MAINTENANCE
The equipment performs periodic self-test, even when turned off. If detected that the battery
charge is below 20% of its maximum capacity, the equipment will emit an audible signal
(beep) and an alarm light, indicating the need for maintenance by text and voice command.

The interval between each automatic test varies proportionally to the battery level, getting
smaller and smaller as the charge drops, that is, as the battery level decreases, alerts
become more frequent indicating the urgency of replacing or recharging the battery (if it is
rechargeable).

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 Battery Level Interval Alert
Above 50% Every 24 hours There is no alarm
Between 20%
Every 10 minutes
and 50% 1 beep pulse;
Between 10% 1 low battery LED pulse.
Every 1 minute
and 20%
Turn off the
Below 10% There is no alarm
Equipment.

Below 2% battery charge it is not possible to turn on the equipment.

If the battery is disposable, as soon as the equipment starts the low battery alarm, contact
CMOS DRAKE immediately for acquisition of a new battery.

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 6
MODE OF USE

ABOUT DEFIBRILLATION

The heart has a system that produces and transmits impulses throughout the heart muscle,
which in turn is responsible for contracting and pumping blood throughout the body. These
impulses can be measured on the surface of the body, generating the electrocardiogram
(ECG).
The analysis of an ECG signal allows the detection of electrical and mechanical problems
in the heart.

Cardiac arrhythmias can reflect disturbances in the initiation or conduction of impulses that,
in the most severe cases, can manifest as Sudden Cardiac Arrest (SCA). During a PCS,
there is a lack of adequate blood flow to the body and brain, which can quickly lead to death
if not reversed. As a PCS rarely reverses spontaneously, the use of a defibrillator may be
indicated to treat it. In this context, the application of a defibrillatory shock aims to restore
the normal rhythm of the heart.

The most common arrhythmias that lead to Sudden Cardiac Arrest are Ventricular
Fibrillation (VF) and Ventricular Tachycardia (VT). An Automated External Defibrillator
(AED) is able to analyze a patient's ECG and recognize the presence or absence of VF and
VT to indicate whether or not a shock should be delivered to the patient. It is important to
point out that, according to the European Resuscitation Council (ERC), the use of an AED
is only indicated in case of Sudden Cardiac Arrest (SCA) patients who are unconscious and
not breathing normally - therefore, the AED should only be used if the patient has such
conditions.

Before using the defibrillator, disconnect all equipment from the patient that does not
have defibrillation protection.

Do not shock with short-circuited blades, as the triggering device may be damaged.

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ANALYZER OF HEART RHYTHMS

The Life 400 Futura Defibrillator is able to analyze the patient's ECG and automatically
identify the presence or absence of Ventricular Fibrillation (VF) and Ventricular Tachycardia
(VT). According to the American Heart Association (AHA), VF and VT are the arrhythmias
that should be treated with shock (shockable) by the AED. Thus, if the Rhythm Class, when
evaluating the ECG of the patient in PCS, identifies the occurrence of a VF or a VT, the
equipment will issue a voice and visual command of the indicated treatment, signaling that
a shock must be administered to the patient.

During the analysis of the patient's ECG, the equipment will issue the voice and visual
command "Analyzing". During this period, for the analyzer to work correctly, the patient must
not be touched, ensuring that the patient is still. At the end of the analysis, the AED will
indicate the treatment (shock) or not, by sound and visual messages on the display. If
treatment is indicated, move away from the patient before pressing the treatment button. If
the AED does not indicate treatment, start CPR.

Validation of the Cardiac Rhythm Analyzer

The performance of the Rhythm Class algorithm was evaluated using defibrillator analyzers
and ECG databases referenced worldwide, the MIT Arrhythmia Database and the CU
Arrhythmia Database. According to the AHA, the performance of the rhythm analyzer should
be evaluated in terms of Sensitivity (Se) and Specificity (Sp):

VP
Se =
VP + FN
VN
Sp =
VN + FP
Key:
FN: False Negative
FP: False Positive
VP: True Positive
VN: True Negative

The performance tests performed resulted in a sensitivity equal to 93.83% and a specificity
equal to 95.01%.

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EQUIPMENT DEFIBRILLATION ENERGY

As per the 2015 AHA Guidelines “Biphasic waveform shock settings differ by manufacturer,
none of which have been directly compared in humans for relative effectiveness. Due to
these differences in waveform configuration, practitioners should use the manufacturer's
recommended power load (120 to 200J) for the respective waveform. If the manufacturer's
recommended load is not known, consider defibrillation at full load.”
The Life 400 Futura Defibrillator is configured with the factory default shock sequence:

ADULT: 150 J – 150 J – 150 J.

CHILD: 50 J – 50 J – 50 J.

Optionally, it is possible to request alternative configurations for other energy sequences for
adult patient shocks:

90 J – 130 J – 150 J.
150 J – 150 J – 200 J.
150 J – 200 J – 200 J.
150 J – 200 J – 360 J
120 J – 150 J – 200 J.
200 J – 300 J – 360 J.
150 J – 170 J – 200 J.
Other settings may be provided.

In cases of pediatric use, the equipment automatically limits the energy, as soon as the
pediatric pads are connected, through the sequences:

50 J – 50 J – 50 J.
50 J – 70 J – 70 J.
50 J – 70 J – 85 J.
Other settings may be provided.

SERVICE SEQUENCE

The equipment automatically starts the sequence of commands and only proceeds to the
next command when the user executes the procedure. The steps of care were designed in
accordance with the chains of survival proposed by the AHA in its guidelines in the 2015
edition (also taking into account the 2020 updates), the sequence of which is shown below.

Recognition of CRA and activation of the emergency medical service;

Immediate high-quality CPR;

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 Rapid defibrillation;

Basic and advanced emergency medical services;

Advanced life support and post-CPA cares.

For all services, the following procedures must be carried out:

1 Check if the patient is unconscious.

1
2 Open the patient’s shirt.
1
1
3 Check if the patient’s skin is dry.
1
1
1 Perform trichotomy (shaving of the hair) if there is excess hair on the patient's
1
4
1 chest for better contact of the electrodes with the patient's chest.
1
1
1
5 Check the expiry date of the electrodes.
1
1
1
1
1
STARTING
1 THE EQUIPMENT
1
1
1
1 Disconnect the battery charger.
1
1
1
1
2
1 Press and release the on / off button.
1
2
1 Wait for the appearance of the Cmos Drake screen and, then the voice command
3 and text Ready for use.
1
2
1
3
1
2
3
1
2
3
1
2
3
1
2
3
2
3
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EQUIPMENT USE SEQUENCE

The AED must remain at a minimum distance of 20 cm from the operator and
1 patient, according to the figure below.
1

2 Start the equipment.

1 Connect the electrodes into the equipment, as shown below, the voice and text
commands “Plug the connector of the electrodes into the equipment” are
3 activated on the equipment.
1
1
1
1
1
1
1
1
1
1
1
1

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 Fix the electrodes into the equipment, as shown below, the voice and text
4 commands “Place the electrodes on the patient’s chest” are activated on the
equipment.
1

1
Sternum-Apex
1

OR

Posterior-Apex

Children with
chest spacing
less than 4 cm

Move away from the patient when indicated by the voice and text commands
5 “Move away from the patient” and “Keep away” from the equipment.
1 Wait for the analysis of the ECG signal when indicated by the voice commands
6 and text “Analyzing” from the equipment.
1
1 Wait for the voice and text commands “Treatment indicated” or “Treatment not
7 indicated” from the equipment.
1
1
1
1
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1
1
1
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 When the treatment is indicated, press the treatment button indicated by the voice
8 commands and text “Press the treatment button” of the equipment.
1 Wait for the voice and text prompts “Perform CPR 2 minutes on the patient”, at
9 the first audible beep initiate chest compression in rhythm with the beep.
1
1
1
1 The 2015 AHA Guidelines say that the electrodes can be fixed in the anteroposterior, left
anteroinfrascapular and anteroright infrascapular position with the same efficiency.
1
1
1 The user should take care to replace a new pair of transthoracic adhesive electrodes after
1
use, so that the equipment is always ready for another emergency.
1
1
1 The user must check the expiration date of the electrodes in order to ensure prompt and
1 prompt service. Expiration information can be found on the packaging label of the
electrodes. If the electrodes are expired, replace them immediately.
1

Disposable electrodes are for single use and therefore should not be reused.

Do not use disposable electrodes if the packaging is damaged.

Do not touch the patient or any accessory connected to the patient during defibrillation.

If there is no triggering (pressing the Treatment Button) within 30 seconds, the shock
capacitor will automatically discharge and the equipment will restart the analysis of the
ECG signal.

Risk of burning the patient's skin when applying defibrillation.

Keep the patient away from conductive and wet surfaces and dry the patient's chest if
necessary, before using the Life 400 FUTURA Defibrillator.

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TURNING OFF THE EQUIPMENT

1 Press the on/off button for 3 seconds until the screen turns off.

1 Check the battery level. For disposable battery, its replacement is

2 recommended when its level indicates 50%.
1
1
3 Disconnect the connector from the equipment’s adhesive electrodes.
1
1
2 Disconnect the accessories from the patient (if it has been used) versions with
1
4
1 ECG and/or SpO2.
2
1
3
1
5 Carry out the cleaning of th AED and non-disposable accessories.
2
1
3
1
4 Reconnect the battery charger to the equipment and in the electrical oulet and
2
6
1
3 keep it always connected so that the battery may remain fully charged.
1
4
2
5
3
7 Send the used adhesive electrodes for disposal.
1
4
2
5
3
6 Connect new adhesive electrodes to the equipment to speed up the next
4
8
2
5 service.
3
6
4
7
5
3
6
4
7
5
6
4
7
5
6
7
5
6
7
6
7

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 7
OPTIONAL

5
MEDICAL MODE

The clinical assessment of the patient's electrocardiogram (ECG) and the decision to
deliver or not shock is determined by the medical rescuer. Therefore, the AED interrupts
its main function of automatic analysis of shockable arrhythmias, starting to operate as a
Manual Defibrillator. In this condition, the physician may deliver electrical shocks to the
patient's chest at his or her discretion, based on his or her judgment.

The steps are simple. Charging and shocking is performed only by the treatment
button, through a command to charge and a command to trigger. Also, the same
disposable electrodes are used in Medical Mode, which must be used only once and then
discarded.

Sequence of Use of the Medical Mode (Manual Mode)

5
1 Turn on the equipment.

1 Press the treatment button for 4 seconds and the message MEDICAL USE will
2 be shown, according to the figure below.
1
1
1
1
1
1
1
1
1
1
1
1

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 Press the treatment button to load, move away the patient, following the
3 equipment’s voice and text commands.
1 Wait for the treatment LED to blink and the voice and text command
4 “Press treatment button”.
1
1 Press the treatment button for application of the shock, the voice and text
5 command “Treatment performed” are activated in the equipment.
1
1
1
1
6 To exit the medical mode, simply turn off the equipment.
1
1
1
1
1
PULSE
1
1
OXIMETRY
1
1 oximetry is a non-invasive method used to measure arterial blood oxygen saturation
Pulse
1
(SpO1 2) and thus monitor and evaluate the functioning of the patient's respiratory and cardiac
1
systems. Pulse oximetry is based on two basic principles: spectrophotometry and
1
1
plethysmography.
1
1
Spectrophotometry measures the amount of light transmitted (or reflected) through the
1
patient's capillaries, synchronized with the cardiac pulse, and plethysmography records the
volume
1 of arterial blood in the tissues (and, consequently, the absorption of light by this
blood) that changes during pulsation. Therefore, functional saturation is calculated, where
oxygenated hemoglobin is expressed as a percentage of the hemoglobin that can carry
oxygen.

The result is provided immediately, where a saturation above 90% is satisfactory from the
perspective of oxygen delivery to the tissues, provided that hemoglobin and cardiac output
are adequate. SpO2 is defined by:

HbO2
SpO2 =
100 - (CoHb + MetHb)
Sensor Operation

The oximetry sensor transmits light beams, produced by two LEDs (diodes), which cross the
patient's body and are captured by a photosensor positioned on the other side of the sensor.
Diodes emit different wavelengths (red and infrared light) through peripheral regions of the
body, such as the fingertips.

The amount of red and infrared light absorbed by oxygen-saturated hemoglobin

(oxyhemoglobin) differs from the amount of light absorbed by oxygen-unsaturated
hemoglobin. This difference in absorption of these wavelengths is measured by the
photosensor, thus calculating the percentage of oxyhemoglobin by comparing the light
absorbed during the pulsation. With all this you get an oxygen saturation reading.

Factors That Compromise SpO2 Reading

Technical artifacts

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 Improper sensor position, application or use.

The emitter and the photosensor must be directly opposite.

Excessive patient movement / vibrations.

Intense ambient light (exposure to surgical lamps, infrared heating lamps,

fluorescent lamps, or direct sunlight).

Patient-related artifacts

Hemoglobinopathies (carboxyhemoglobin or methemoglobin).

Hypothermia: Reading may be compromised by vasoconstriction.

Anemia: there may be an underestimated reading when hemoglobin is less than 5

g/dL.

Venous congestion: due to the presence of a venous pulse, the reading may be
underestimated.

Enamels: can compromise reading, especially in black, blue and green colors.

Intravenous injections: some substances such as methylene blue, indocyanine green

and indigo carmine have spectral activity at the wavelengths used for pulse oximetry.
This interferes with the accuracy of the readings..

Prolonged Use of the Sensor

Oximetry sensors (adult, child or universal) are not indicated for prolonged use, due to the
heat emitted by the sensor and the continuous pressure exerted on the patient. In case of
monitoring for a longer period, it is recommended to reposition them in another location on
the patient every 4 (four) hours.

Characteristics
Pulse oximetry, with plethysmographic curve and numerical oxygen saturation
indication in percentage; amplitude of the plethysmographic waveform adjusted on
the screen.

Pulse oximetry is used in situations where oxygen saturation (SpO2) is essential: in

anesthesia, during surgery, in the postoperative period, in patients in intensive care,
in ambulances and even in homes.

The use of the oximetry sensor is prohibited in the MRI room due to its constitution.
Metallic parts cannot be used in the room.

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Use of the Clip Type Sensor

Make use of the sensor on the index finger, if this is not possible, preferably use a small
finger; do not use the thumb sensor.
Pay attention to the following guidelines:

Check if the sensor is dry.

Position the sensor as shown below.

Keep cables connected to the mains supply away from sensor cables and
connections.

Avoid using the sensor in places with intense lighting. If necessary, cover the sensor
region with opaque material.

When selecting a sensor location, choose a device-free end such as: arterial catheter,
blood pressure monitor, or intravascular infusion lines.

When reading errors are found, the user must accommodate the patient in order to correct
his posture and return blood circulation normally, thus being able to restore the quality of
the signals. Check the sensor application every two hours and the patient's skin. If skin
quality is compromised, change sensor location.

We recommend changing the sensor placement every 4 hours. If the sensor fails to function,
remove it from the patient immediately. Avoid applying tape or tape over the reusable
sensor. This reduces the risk of venous pulsation, erroneous saturation measurements and
the possibility of pressure damage to the area. However, applying a tape over the cable can
help prevent the sensor from slipping out of place.

Sensor expiry date: Indeterminate.

Use of the Y Type Sensor

The recommended sensor for infant/neonatal application is the Y-model. The fixation of this
sensor is done by means of an adhesive tape around the foot; other sites may not provide
acceptable results, due to incorrect perfusion or inadequate light.

Make sure that the fixation tape is securely fastened, but not too tight, thus avoiding
interference with blood flow, which can cause incorrect readings or skin damage. If the

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sensor is not positioned correctly (alignment between the emitter and the receiver),
inaccuracies and instabilities in the reading and in the plethysmographic curve may occur.
Prevent radiant light from radiotherapy equipment from reaching the tissue and interfering
with the SpO2 measurement.

Patient foot movements can misalign the transceiver assembly (Y sensor) and result in
inaccuracies in SpO2. Correct sensor placement is critical for good oximeter performance.

Important Features of the Y-Sensor:

Pediatric patients: Weight from 15-40 kg;

Change location every 4 hours;

Sensor expiry date: Indeterminate.

When positioning the sensors, the integrity of the skin must always be observed. Patients
with burns that may exhibit greater sensitivity to heat and pressure should receive special
care, such as changing the applied area of the sensor more frequently.

Do not use the oximeter for continuous monitoring.

Warnings for Choice of Sensor

Oximetry sensors are designed for weight ranges and for specific locations, so pay
attention to the patient's weight when choosing the sensor and for proper sensor
perfusion.

Never use alternative sensors not supplied by the Manufacturer.

Sequence of Use of the Oximetry Mode

Connect the SpO2 sensor to the left side SpO2 connector of the equipment, as shown
1 in the figure below.
1

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 Place the sensor on the patient's finger, ensuring that the connector is properly
2 seated.
1

The display shows the plethysmography curve and the patient's oxygen
3 saturation value, as shown below.
1

1
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 To cancel the oximetry reading, simply disconnect the SpO 2 sensor from the
4 equipment.
1

1
Use only SpO2 sensors supplied by CMOS DRAKE. Other sensors may cause poor
1 performance and/or non-functioning of the feature.

1
The oximetry reading does not interfere with the analysis of the ECG signal to determine
1 whether or not treatment is indicated.

3-WAY
1 ECG MONITORING
The Life 400 Futura Defibrillator offers an optional 3-way ECG cable input, so that the
rescuer can use the ECG cable for continuous monitoring of the patient's electrocardiogram.
This monitoring is done by 3 disposable ECG electrodes. If, during monitoring, the patient
progresses from their sinus rhythm to a shockable arrhythmia, the AED will detect the need for immediate
defibrillation and instruct the rescuer through text and voice commands.

When using the 3-way ECG cable, “MONITORING MODE” will appear on the equipment
screen.

The AED must not be used in continuous monitoring and does not have an alarm system.
The patient must be assisted by the rescuer.

When connecting the Adhesive Shock Pads, disconnect the ECG cable from the patient.

Do not trigger the shock through the pads with the ECG cable connected to the patient.
This procedure can cause burns where the ECG electrodes are connected.

When monitoring via the 3-way patient cable, the AED does not automatically indicate
treatment. However, the equipment starts performing another routine that monitors the
patient's cardiac signal and searches for arrhythmias to alert the operator.

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 To use Monitoring Mode, make sure the shock pads are not connected to the AED.

Sequence of Use of the Monitoring Mode

Connect the ECG cable to the left of the equipment as shown in the figure
1 below.
1

Perform trichotomy (shaving of the hair) if there is excess hair on the patient's chest for
better contact of the disposable ECG electrodes with the patient's chest.

2 Check the expiry date of the disposable ECG electrodes.

3
3 Fix the disposable ECG electrodes on the chestt as shown in the figure below.
3
4
3
4
3
4
3
4
3
4
3
4

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 Connect the 3-Way ECG cable to the disposable ECG electrodes attached to the
4 patient. The equipment shows on the MONITORING MODE screen as shown
below.
2

Upon identifying any arrhythmia, the voice and text commands Arrhythmia
5 detected and place the shock electrodes will be issued.
1

1 To cancel he monitoring mode, simply disconnect the equipment’s 3-Way ECG

6 cable.
1
1
1
1
1
1
1
1
1
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CPR FEEDBACK DEVICE
The feedback device is an accessory that provides feedback on the quality of compressions
applied by the user. The product is optional, which is interconnected with disposable shock
pads, and is also for single use.

Cardiopulmonary Resuscitation (CPR) is an emergency procedure used in unconscious,

pulseless, and breathing patients. When the patient has these problems, there is a lack of
oxygenation in the brain. Therefore, it is essential to apply quality CPR as soon as possible,
because about 30 seconds after restriction of oxygen in the brain there is loss of
consciousness, after 3 minutes there may be irreversible neurological sequelae and after 6
minutes without oxygen there are high chances. of death of the victim.

The application of high-quality CPR is essential for the survival of patients with cardiac
arrest. In this sense, the American Heart Association in its 2015 Guidelines identified five
essential components to perform quality CPR:

Compression Rate from 100 to 120 compressions per minute;

Compression Depth of 4 cm (infant) or 5 to 6 cm (adult);
Allow full recoil of the chest between compressions;
Avoid interruptions in CPR;
Limit lung ventilation to 10 breaths per minute.

The incidence of sudden cardiac arrest is between 50 to 100 per 100,000 individuals. If CPR
is immediately applied, the chance of survival increases significantly.

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During the application of CPR there can be complications, the most common being: fracture
of ribs or sternum, bleeding in the chest cavity, hematoma in the heart and damage to the
lungs. In this sense, the CPR Feedback Device is essential to facilitate and improve the
quality of CPR, reducing the chance of harm to the victim during CPR application.
The CPR Feedback Device is designed to assist the rescuer in delivering AHA Guidelines
CPR to adult patients. Each device is equipped with intelligent circuitry capable of identifying
the rate, depth of compressions and issuing, in real time, text and voice commands to the
AED so that the operator adjusts CPR to the ideal parameters of the AHA.

In this way, both experienced rescuers and those performing first-time CPR will be able to
continually improve the quality of care delivered in accordance with AHA definitions. The
feedback device is also ideal for CPR instructors and their students to train in high quality
CPR application.

The device is operated in a simple way, just connecting it to the AED and placing it on the
patient's chest for it to start working. It does not require any calibration or complicated
assembly. Its compact, ergonomic, non-stick design allows for safer and more efficient CPR.

CPR Feedback Device Operating Parameters

Component Recommended Value

Duration of CPR Cycle 2 minutes

Frequency of
100 to 120 compressions/min
Compressions

Depth of Compressions 5 to 6 cm

Maximum Interruption Interruptions less than 10 seconds

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Sequence of Use of the CPR Feedback Device

The equipment must remain at a minimum distance of 20 cm from the operator

1 and patient, according to the figure below.
1

2 Start the equipment.

1 Connect the electrodes into the equipment, as shown below, the voice and text
3 commands “Plug the connector of the electrodes into the equipment” are
1 activated on the equipment.
1
1
1
1
1
1
1
1
1
1
1

Fix the electrodes on the adult patient, as shown below, the voice and text
4 commands “Place the electrodes on the patient’s chest” are activated on the
equipment.
1

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Sternum-Apex

OR

Posterior-Apex

Move away from the patient when indicated by the voice and text commands
5 “Move away from the patient” and “Keep away” from the equipment.
1 Wait for the analysis of the ECG signal when indicated by the voice commands
6 and text “Analyzing” from the equipment.
1
1 Wait for the voice and text command “Treatment indicated” or “Treatment not
7 indicated” from the equipment.
1
1
1 If the treatment is indicated, press the treatment button when indicated by the
1
8
1 voice commands and text “Press the treatment button” of the equipment.
1
1 Place the CPR feedback device as shown below, when indicated by the voice
1
9 and text commands “Place CPR feedback device on patient's chest” on the
1
1 equipment.
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1

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 Perform CPR on the patient, the voice and text commands “Perform CPR for
10 2 minutes” are triggered on the equipment.
3
11 Follow the voice commands during CPR, as shown in the table below.
3

3 Voice Command Description

Follow the beat of the The device is indicating that the compression
3 beep frequency is off-optimal
The device is indicating that the depth of
3 Compress harder
compressions is below what is needed
3 The device is indicating that the depth of
Compress weaker
compressions is above what is needed
3 Device is indicating interruption in
Continue CPR
compressions
The device is indicating that the
Good compressions
compressions are good

The AHA Guidelines establish that the electrodes can be fixed in the anteroposterior, left
anteroinfrascapular and anteroright infrascapular position with the same efficiency.

The user should take care to replace a new pair of transthoracic adhesive electrodes after
use, so that the equipment is always ready for another emergency.

The user must check the expiration date of the electrodes in order to ensure prompt and
prompt service. Expiration information can be found on the packaging label of the
electrodes. If the electrodes are expired, replace them immediately.

Disposable electrodes are for Single Use and therefore should not be reused.

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 Do not use disposable electrodes if its packaging is damaged.

Visual depth indicator

The CPR feedback device displays a graphical indicator on the screen to show the
compression depth in real time, as shown below.

The colors indicate the compression performance, as shown below.

Almost without Compression in

No compression
compression progress

Almost ideal Optimal

Overcompression
compression compression

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Display Icons for Guidance During Service

Ready to use. Treatment performed.

Open the patient’s shirt. Treatment not indicated.

Remove the electrodes from If there is no circulation,

the packaging. perform CPR for 2 min.

Fit the electrodes into the Place the CPR feedback

equipment. device on the patient's chest.

Place the electrodes on the

Follow the beat of the beep.
patient's chest.

Stay calm, ask for help. Perform CPR for 2 min.

Move away from the patient. Compress harder.

Keep away. Compress weaker.

Analyzing. Continue CPR.

Treatment indicated. Good compressions.

Press the treatment button.

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EMERGENCY CABIN
The emergency cabin is designed for wall mounting to protect equipment and accessories
and provide easy access during emergencies. When opening the cab, an audible alert will
sound. The alarm will stop when the cab door is closed.

Made of steel and available in yellow or red, as shown below.

It is recommended that the Equipment and its accessories, when not in use, be properly
stored in the BLS professional bag or in the emergency cabin in order to protect them.

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 8
MANAGING DATA

DESCRIPTION

The Phoenix software makes it possible to visualize all the events that occurred while using
Cmos Drake products. Through the USB cable it will be possible to transfer the data to the
Phoenix software and to analyze the events recorded during the use of the AED in detail.
Phoenix also allows software upgrade of Cmos Drake equipment (authorized personnel
only).

INSTALLATION OF THE DATA RECORDING SOFTWARE

Minimum Requirements
Operating System Windows 7 or higher
Processor 1 GHz clock or higher
RAM Memory 1 GB or higher
Disc Space 200 MB free or higher
Others Internet Access

Installation Procedures

1 To perform the Phoenix Software download, access the following glink or use the QR CODE
below: https://www.cmosdrake.com.br/content/uploads/manual/Phoenix.rar
1

1
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2 After conclusion of the download, decompress the file and run it.

3
Install the Software by following the procedures below:
3
3
4
3
1. Select your language and press “OK”.
4
3
4
3
4
3
4
3
4

4
2. In the next window, click “Next”.

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3. Select a directory of your choice

4. Click “Next” again

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5. If you want a shortcut to be created on the desktop, check
the text box. Then press “Next”

6. Click “Install”

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 7. Click “Finish”.

OPERATING THE PHOENIX SOFTWARE

Downloading AED Data

1 Start the Phoenix software

1 Connect the USB cable to the AED and to the computer as shown in the figure
2 below.
1
2
1
2
1
2
1
2
1
2
1
2

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3 Click on “File > Import from Equipment”.

Mark the option “Receive data from the Equipment” and click on “Perform
4 operation” ”.
3

3
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5 Choose a folder to save the data and click “Save”.

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 6 Mark the desired events and click “Transfer”.

Viewing Stored Data

1 Start the Phoenix software

3
2 Click “’File > Open”.
3
3
3
3
3
3
3
3
3
3
3
3

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 Open the folder containing the AED data, select the desired event and click
3 “Open”.
3

3 tabs will appear on the screen: Curves, Events, General Information. To switch
4 between tabs, simply click on the tab directly, or through the “View” menu.
3

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Curves: They display the patient's ECG curve as viewed during the service. In addition, the
image is accompanied by a grid containing the date and time of each part of the ECG signal
and the most relevant events are displayed by default on the ECG curve, for the purpose of
analyzing the service.

Events: To view the events in detail, their period of occurrence and description, select the
“Events” tab.

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General information: On the General Information tab, the user can fill in patient and
operator data. There is also a comment field that can be used to include additional
information.

Exporting Service Data

1 Click on the icon indicated on the figure below to save data in PDF.

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2 Mark the interval of desired pages and click “Save”.

3 Choose a folder to save the PDF and click “Save”.

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Printing Files

Click the icon shown below or click “File > Print” to print the document. Make sure your
printer is properly configured on your computer.

Copying Phoenix Content

Click on the icon indicated below or click on “Edit > Copy” to copy the contents of the
selected tab. This functionality operates as follows:

ECG Tab – It will copy an image to the transfer area (clipboard).

Events tab – It will copy text contained in the selected table cell.
General Information tab – It will copy the text contained in the selected area.

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Changing Language

Click on “Tools > Languages” and select the desired language.

Switching Page

To advance to the next page, click on the icon ;

To return to the previous page, click on the icon ;

Enlarging or Reducing the Screen

Click the icon , or right click on the screen, select Zoom and slide the slider to the left,
this will zoom out the screen.

Click the icon , or right click on the screen, select Zoom and slide the slider to the right,
this will zoom the screen.

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Obtaining Information about Phoenix

Click on the icon shown below or click on “Help > About”.

A window will open with information about the software version and contact for support in
case of doubts.

To download the latest software use the QR CODE below:

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 9
MAINTENANCE

PRECAUTIONS AND SPECIAL CARES

Do not lean any type of material against the equipment;

Do not reuse disposable materials, after use they must be discarded in appropriate
places according to special procedures for hospital waste;

We recommend keeping some auxiliary materials such as surgical scissors, a

disposable razor blade for chest hair removal and disposable gloves, if necessary.

For greater durability of the Life 400 Futura Defibrillator and its accessories, we recommend
that preventive inspections and cleaning be carried out periodically following the table below.

Applied Verification Frequency

Cleaning Weekly
Preventive Inspections Biannual
Revision in Authorized
Annual
Technical Assistance
Mandatory Calibration Annual

For each process, make sure that the equipment is turned off and its electrodes are
disconnected.

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CLEANING OF EQUIPMENT AND ACCESSORIES

The equipment and its non-disposable accessories must be cleaned after each use or when
visible dirt is detected. If it has not been used, it is recommended that cleaning be carried
out quarterly. All cleaning procedures must be carried out at room temperature.

Do not spill any type of liquid and/or place needles and objects in general on the equipment
and/or accessories.

Do not immerse the equipment and accessories in any type of liquid for cleaning.

Cleaning of the Equipment

1 Disconnect the equipment from the electric mains.

1
2 Gather together the equipment and the battery charger for cleaning.
1
2 Prepare a cloth slightly dampened with water and neutral liquid soap and a cloth
3 dampened with 70% ethyl alcohol.
1
2
3
1
2 Do not use cleaning agents with abrasives, organic solvents, chlorine, alcohol or
3
1 hydrocarbon solvents.
2
3
1
2 The labels present on all items (AED, Accessories and Battery Charger) are important, and
3 therefore must not be removed and must not be damaged when cleaning.
1
2
3
2
3
4 Clean the Equipment case and charger using the cloth with soap and water.

3
1
5 Disinfect the Equipment case and charger using the cloth with alcohol.
1
2 Carefully wipe the display with a dry flannel or, in case of dirt, a cloth slightly
6 dampened with water to remove dust and dirt particles.
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
2
3

3
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Cleaning of the Accessories

1 Disconnect the sensors of the equipment.

1
2 Gather together the non-disposable accessories for cleaning.
1
2 Prepare a fabric lightly moistened with demineralized water and neutral liquid
3
1 soap, a soft fabric slightly moistened with demineralized water and a fabric
2 moistened with 70% ethyl alcohol.
3
1
4
2 Clean the sensors using the cloth with soap and water.
3
1
1
2
5
3 Remove the soap from the sensors using the soft cloth with water.
1
1
2
1
3
1
6 Disinfect the sensors using the cloth with alcohol.
1
2
1
3
1
1
2
7 Disinfect or dispose of used cloths.
1
3
1
1
1
3
1
DISPOSAL
1
1 OF EQUIPMENT AND ACCESSORIES
1
1
Electronic equipment and its parts that reach the end of their useful life must be sent to the
1
1
manufacturer for proper disposal, thus preserving natural resources and contributing to the
1
1
conservation of the environment.
1
1
1 Waste from electrical and electronic equipment. Dispose of separately from other
1
objects in the establishment.
1
Disposal of Equipment at End of Useful Life
At the end of the equipment's useful life (period greater than 5 years), the customer must
contact the Manufacturer to receive instructions for the disposal of the equipment,
accessories and battery charger. Consult the local Environment Department in your city
where the Equipment is installed, as it may dispose of it. Cmos Drake will also be able to
receive the equipment, accessories and battery charger, will disassemble them by
separating recyclable and non-recyclable parts.

The recyclable parts will be sent to companies duly accredited and qualified to recycle
materials. The non-recyclable parts will be sent to accredited companies that follow the
resolutions of CONAMA and the presidency of the republic for the disposal of non-recyclable
materials.

Battery Disposal
Battery disposal

For batteries that are disposable, that have reached the end of their recommended life (more
information in Chapter 4 – Battery) or that show any deterioration in charge capacity and/or
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performance, contact the Manufacturer for disposal instructions. of the battery. Consult the
local Environment Department in your city where the Equipment is installed, as it may
dispose of it.

Disposal of Accessories
For disposable accessories such as shock pads, follow local regulations for medical waste.

PREVENTIVE INSPECTIONS
We recommend that the Life 400 Futura Defibrillator and its accessories be inspected every
six months, regardless of whether the equipment has been used or not, following the
instructions below:

Check that the equipment has all the accessories and components necessary to carry
out an eventual service that may occur.

Check the expiry date/expiration of (disposable shock pads). The validity of the
blades is in the format YYYY/MM (year/month) on the label affixed to their packaging,
as shown below. If any of these accessories are close to expiration or are already
expired or in poor condition, we request that you purchase new material from Cmos
Drake or an authorized representative.

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 Never use alternative pads available on the market. This procedure will effectively
compromise the analysis of the Patient's ECG.
Only purchase the original blades supplied by CMOS DRAKE as identified above.

Check the conservation of the equipment and its accessories, if there is any
irregularity in the equipment, it must be sent to the manufacturer for maintenance,
and in the case of accessories, a new material must be purchased only by the
manufacturer.

Turn on the equipment and check the battery charge level (via the visual battery
indicator on the display). If it is low, it will be necessary to recharge or replace the
batteries (instructions on how to proceed in Chapter 4 - Battery).

Preventive Maintenances
Maintenance and periodic testing of the equipment and its accessories are preventive
measures that help to prevent and detect possible electrical and mechanical failures. During
the maintenance schedule recommended by CMOS DRAKE, if the test identifies a possible
problem with the equipment, accessories and sensors, remove it from use immediately and
contact the qualified technical area.

Programming of Tests and Maintenance

It is recommended that the following preventive inspection schedule be used in conjunction
with the hospital's internal quality control program or any location where the AED is used.
To record the results of the periodic inspection and help the operator to verify the
recommended corrective action for simpler problems, a list to be followed, called Checklist,
is provided, which must be kept close to the equipment and is available for highlight at the
end of this user’s manual.

The electrical safety, performance and calibration tests of the equipment must be performed
by qualified technical assistance authorized by CMOS DRAKE.

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 Occasionally Periodically
If 3 6 12
Before After Every Every
Programming Neces Month Month Month
Use Use Day Week
sary s s s
Check the expiry date of the
adhesive shock pads X

Inspect the equipment (visual

and mechanical) X X

AED cleaning X X

Cleaning of accessories X X

Check that all necessary

materials are complete X

Check screen message and

voice command X

Electrical safety test X

Electrical safety test after

technical intervention X

Test with Defibrillator

Analyzer in 1st and 2nd year X

Test with Defibrillator

Analyzer in 3rd year onwards X
Turn on the AED, check
“Ready to Use” and check X X X
battery charge level

To test the equipment, follow the procedures below:

Partial Test

1 Turn on the equipment.

1
2 Observe the battery level on the display. If low, charge immediately.
1
1 Wait for voice and text commands until the phrase:
3 Place the electrodes on the patient's chest.
1
1
1
1
4 Turn off the equipment.
1
1
1
1
5 Keep the battery charger plugged into the AED and electrical outlet.
1
1
1
1
1
1
1
Complete Test
1
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1
1
1
1
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1
 1 Turn on the equipment.

1
2 Observe the battery level on the display. If low, charge immediately.
1
1
3 Connect your Defibrillator Analyzed into the AED.
1
1
1 Select th Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT) ECG wave
1
4
1 on the Defibrillator Analyzer.
1
1
1
5 Wait for voice and text commands of the indicated treatment.
1
1
1
1
6 Press the treatment button and the shock will be triggered in the Analyzer.
1
1
1
1
7 Check the energy delivered in the Analyzer.
1
1
1
1
8 Turn off the equipment.
1
1
1
1
9 Keep the battery charger plugged into the AED and electrical outlet.
1
1
1
Any1
1eventual failure in the mentioned tests, contact the Authorized Technical Assistance
immediately.
1
1
1
1
Equipment Calibration
1
1
1
Every
1 12 months the equipment must be sent to the authorized technical assistance for
1
preventive maintenance and calibration. This procedure ensures that all equipment
1
functionalities are in full working condition.
1
1
Periodic calibrations must be performed as follows:
1
Advisable calibration after warranty: 3 months.
Recommended calibration after warranty: 6 months.
Mandatory calibration after warranty: 12 months.

The equipment calibration aims to keep the equipment with all its functionalities and within
the technical standards of hardware and software. Calibration is understood as the
measurement of electrical data and values, circuit waveforms, verification of circuit current
and voltage levels, and the respective adjustments to correspond to the project’s established
standard values . During the measurement, if it is impossible to make the necessary
adjustments, the replacement of parts and components will be made to guarantee the
calibration. Therefore, calibration can only be performed by professionals trained by the
manufacturer and who prove that they have the following equipment necessary for perfect
calibration:

Electrical safety analyzer.

Defibrillator analyzer with display that visualizes the truncated exponential curve
Pulse oximetry analyzer for version with SPO2.
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 Oscilloscope.
Digital multimeter.

All the above equipment must be calibrated by an accredited body, within the validity periods
and must be attached to the calibration report. Equipment that is calibrated by companies
not authorized by CMOS Drake will lose its lifetime warranty and several risks of material
damage due to incorrect intervention in the equipment may occur, directly impacting other
risks.

Never forward the Life 400 Futura Defibrillator (high risk) to unauthorized Technical
Assistance or hospital internal maintenance departments, whether for preventive,
corrective or calibration maintenance, subject to penalties provided by the National Health
Surveillance Agency - Anvisa.

The AED Life 400 Futura Defibrillator was designed and built within national and
international regulatory and regulatory standards. Technical safety standards regarding
technical intervention in the product must be applied.

The Authorized Technical Assistances undergo intense training for the correct technical
intervention in the equipment, whether for corrective, preventive maintenance and
calibrations. The factory applies intensive training, provides electronic diagrams, original
parts and components, up-to-date software versions, and keeps authorized ones up-to-date
for desired upgrades. The dedicated AED board is a multi-layer board with SMD and discrete
components, manufactured following IPC (Association Connecting Electronics Industries)
guidelines, assembled under careful technical procedures with controlled temperature, anti-
static environment, lead free soldering, solder technology in ENIG bath (Electroless Nickel
Immersion in Gold) among other modern techniques in electronic circuit design.

IPC-DR-572 IPC-1601 IPC-6013 IPC-9151

IPC IPC-A-600 IPC-4761 IPC-6015 IPC-9194
Printed Board / IPC-OI-645 IPC-6011 IPC-6017 IPC-9199
Acceptance IPC-1710 IPC-6012 IPC-6018 IPC-9241
IPC-9252 IPC-9631 IPC-9641 IPC-9691

CMOS DRAKE advises owners of the AED defibrillator Life 400 Futura not to perform
technical services in unauthorized technical assistance. Otherwise, the equipment may be
damaged by undue interventions, compromising the correct functioning of the equipment,
incurring serious errors in functionality, risk management, usability, and even more serious,
it may fail during service.

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TROUBLESHOOTING

Problem Recommended Action

Press and hold the power button for at least 3

seconds; or

Equipment does not turn Check if the battery is installed incorrectly and, if
on. necessary, fit it correctly; or

Check the condition of the battery and whether it is

discharged. If necessary, recharge or replace the
battery.

Check if the electrodes connection to the AED is

correct; or

The Equipment turns on, but Check if the adhesion of the electrodes to the Patient
keeps repeating the is adequate and if he is moving excessively; or
message “Place the
Electrodes on the Patient's Check if the patient has hair on the chest, it will be
chest”. necessary to perform Trichotomy (shaving the hair);
or

Check that the electrodes are in good condition and,

if necessary (and possible), replace the electrodes.

Check that the connection of the SpO2 sensor to the

AED is correct; or

Check that the sensor is correctly positioned on the

The Equipment does not
patient's finger and that it is moving excessively; or
display the SpO2 curve,
even with the sensor Check for direct light on the SpO2 sensor (light may
connected. interfere with the reading of the Patient's oximetry
signal); or

Check that the sensor is in good condition and, if

necessary (and possible), replace the sensor.

This is the self test, a sign that the battery is low and
The Equipment beeps therefore needs to be recharged or replaced. If the
frequently. battery has been recently charged and used little, but
is not holding a charge, contact the Manufacturer to
send it for disposal and replace it with a new one.

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 The AED had a very low battery before the
The Equipment emits a treatment, a sign that the battery should be
“beep” and turns off after recharged or replaced. The process of charging the
indicating treatment. capacitor to deliver a shock is energy intensive and
can cause the battery voltage to momentarily drop
below the critical shutdown level.

Check if the USB cable was correctly inserted in the

Equipment and in the computer; or
The Equipment is not
identified by the data Check if the computer has installed the Equipment
recording software or the driver correctly and, if necessary, wait for the
computer. complete installation of the computer; or

Restart the computer.

Wait for the device to automatically restart. If it does

not occur within 3 seconds, press the equipment
Equipment is blocked for on/off key and check if it returns to normal operation;
unknown reason. or

Check if any adverse external events occurred in the

environment where the equipment is being used.

OBSERVATION: If the recommended actions are not sufficient to correct the problem,
contact Cmos Drake Authorized Technical Support.

ADVERSE EFFECTS

CMOS DRAKE, as a manufacturer of medical and hospital equipment, requests users to

report possible defects or the occurrence of any undesirable event, in order to guarantee
the quality of the equipment, accessories and battery charger. Therefore, any failure or
malfunction, please contact the nearest authorized technical assistance or directly with the
sales consultant at the telephone or website indicated below on the last page of this manual.

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 A
APPENDIX A

1
LIST OF BASIC ACCESSORIES

Description Reference Supplier Image

Cmos Drake
LT49131
Adhesive and FIAB
Disposable
Shock Pads
(ADULT) Cmos Drake
LT72471
OBS

LiPo Battery
LT31651

7
Battery Charger Cmos Drake
LiOn Battery
LT48509

Shielded USB Cmos Drake

A/B Cable for 35375 Computer
Data Transfer Stores

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BLS Professional
Bag for basic life 33940 Cmos Drake
support for AED

Printed User’s
Manual and
Phoenix Software
12486 Cmos Drake
(Download via
link in manual
and QR code)

Certificate of
Equipment N/A Cmos Drake
Warranty

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LIST OF OPTIONAL ACCESSORIES

Description Reference Supplier Image

Cmos Drake
LT49147
Adhesive and FIAB
Disposable
Shock Pads
(CHILD) Cmos Drake
LT72488
OBS

Cmos Drake
LT218 Biolight
Oximetry Sensor Nellcor
Clip Type
(ADULT) Cmos Drake
LT72460 Orantech
INC

Oximetry Sensor Cmos Drake

Soft Type LT247 Biolight
(CHILD) Nellcor

Cmos Drake
LT231 Biolight
Nellcor
Oximetry Sensor
Y Type
Cmos Drake
LT72465 Orantech
INC

ECG Electrodes
and Cable LT483 Cmos Drake
3 Way

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Disposable ECG
Electrodes 661 Cmos Drake
(ADULT)

CPR Feedbac
Device and
Adhesive and
LT56673 Cmos Drake
Disposable
Shock Pads
(ADULT)

Emergency Cabin
54384 Cmos Drake
for AED

BLS Rescue Bag 1815 Cmos Drake

Cmos Drake Blunt tip scissors

Gloves
Cleaning Kit 23188 Medical Depilatory wax
supply Mask
stores Blade for shaving hair.

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 LiPo Battery
LTSP32

LiOn
Additional Standard
Rechargeable Battery Cmos Drake
Battery
LTSP33
LiOn Plus
Battery
LT57879

Disposable LiMn Battery

Cmos Drake
Battery LT41170

All accessories must be stored in a ventilated place and free from moisture, dust, light
(including sunlight) and fibers from other materials such as cotton. The mentioned
components can interfere with the correct use of the accessories or even lead to a total
impairment of their functioning.

Before putting the equipment in contact with the patient, the operator must regularly check
that it is in working conditions.

Use only the accessories, consumables and others listed in this manual. CMOS DRAKE
does not guarantee the proper functioning of the equipment with the use of unknown
accessories, in addition to not being responsible for failures in the operation of the
equipment or possible damages caused by them.

In general, the EQUIPMENT Parts and ACCESSORIES of the Automatic External

Defibrillator - AED, intended to come into contact with biological tissues, cells or body
fluids are tested and analyzed in accordance with the guidelines and principles of ISO
10993-1, which deals exclusively with testing of biocompatibility of the applied parts.

Cmos Drake guarantees that all permanent and disposable materials in contact with the
patient do not cause any type of damage or harmful physiological effect, provided that: the
procedures described in this manual are followed; that they are installed in an appropriate
medical place; that it is used with the correct accessories; be operated by trained
personnel and that all precautions described in this User’s Manual are followed.

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 B
APPENDIX B

EQUIPMENT TECHNICAL SPECIFICATIONS

Compliance with Standards and Certifications

In Compliance with the Standards NBR IEC 60601-1:2010+Em.2016;

NBR IEC 60601-1-2:2017;
NBR IEC 60601-2-4:2014;
NBR IEC 60601-2-27:1997;
NBR IEC 60601-1-12:2020;
MDD 93/42/EEC:2007;
EN ISO 14971:2007;
EN ISO 13485:2003;
Among others
Relevant Certifications Product Certification - INMETRO
Ministry of Health Registration 80058130008

General Specifications

Dimensions 295 mm x 225 mm x 155 mm

Weight Approximately 3 kg
Internal Memory 4 GB: Recording capacity of data referring
to 1000 events

Operation Specifications

Operating Temperature 0 °C to 50 °C
Operating Humidity 5% to 95%, without condensation

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 Operating Atmospheric Pressure 620 hPa to 1060 hPa (465 mmHg to 795
mmHg)
Operation Mode Non-continuous operation mode
ON – Capacitor average load: 6 seconds
OFF – Min. interval between shots: 30
seconds
Maximum Cumulative Time of Approximately 6 hours (battery life)
Operator/Patient Exposure to the
Equipment

Transitory Operation Specifications

Temperature -20 °C to 50 °C
Humidity 15% to 90%, without condensation
Time of a transient condition Period not less than 20 minutes

Storage and Transport Specifications

Storage Temperature -10 °C to 45 °C

Transport Temperature -10 °C to 45 °C
Storage Humidity 10% to 95%, without condensation
Storage Atmospheric Pressure 620 hPa to 1060hPa (465mmHg to
795mmHg)
Maximum Stacking 5 boxes
Box for Transport Transport in original box of the equipment.
CMOS DRAKE does not guarantee and is
not responsible for any damage that occurs
to equipment that is transported or stored in
other packaging.

Safety Specifications

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 Classification of Applied Parts Shock Pads:
Defibrillator-proof CF type applied part
SpO2:
Defibrillator-proof BF type applied part
ECG:
Defibrillator-proof CF type applied part
CPR Feedback:
Defibrillator-proof CF type applied part
Protection against Harmful Water IP56
and dust Penetration
Safety Degree of Use in Presence of Equipment not adequate for use in the
Flammable Anesthetic Mixture presence of flammable mixture with air, O2
and N2O

Degree of Protection Against Model with rechargeable battery:

Electric Shock Internally powered when operating and
class II when battery is under load
Model with disposable battery:
Internally powered
Means of Separation between Network plug
Equipment and Electricity Grid

OBSERVATION: Despite having different functions, the shock pads and ECG cable are the
same applied part.

Do not use both Permanent Shock Pads/Disposable Shock Pads and ECG electrodes at
the same time, to avoid damage in case of discharge.

Internal Battery Specifications

Rated Voltage Rechargeable Lithium-Polymer:

11.1 VDC
Rechargeable Lithium-Ion Standard:
14.8 VDC

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 Rechargeable Lithium-Ion Plus:
14.8 VDC
Disposable Lithium-Manganese:
15.0 VDC
Rated Charge Rechargeable Lithium-Polymer:
2200 mAh
Rechargeable Lithium-Ion Standard:
2850 mAh
Rechargeable Lithium-Ion Plus:
3500 mAh
Disposable Lithium-Manganese:
3500 mAh

Operating Temperature Rechargeable Lithium-Polymer:

0ºC to 45ºC
Rechargeable Lithium-Ion Standard:
0ºC to 45ºC
Rechargeable Lithium-Ion Plus:
0ºC to 45ºC
Disposable Lithium-Manganese:
0 to 60ºC
Full Charge Time Rechargeable Lithium-Polymer:
4 hours
Rechargeable Lithium-Ion Standard:
4 hours
Rechargeable Lithium-Ion Plus:
5 hours
Disposable Lithium-Manganese:
N/A
Charging / Discharging Cycles Rechargeable Lithium-Polymer:
500
Rechargeable Lithium-Ion Standard:
500
Rechargeable Lithium-Ion Plus:
500
Disposable Lithium-Manganese:
N/A

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Battery Charger Specifications

In Compliance with the Standards FCC CE(EN55024,EN6100) C-TICK;

UL1310; and
EN55014
Relevant Certifications CE;
RoHS; and
UL
Cabinet ABS Plastic; and
PA
Dimensions 74 mm x 28 mm x 42 mm
Weight Approximately 60 g
Operating Temperature 10ºC to 40ºC
Operating Humidity 30% to 75%
Operating Atmospheric Pressure 700 Pa to 1060 Pa (525 mmHg to 795
mmHg)
Operation Mode Continuous
Storage Temperature 0ºC to 50 ºC
Storage Humidity 10% to 95%, without condensation
Operating Atmospheric Pressure 700 hPa to 1060 hPa (525 mmHg to 795
mmHg)
Type of Protection Against Electric Class II
Shock
Protection against Harmful Water IPX0
and dust Penetration
Means of Separation between Network plug, AC UE and 5.5 mm x 2.1
Equipment and Electricity Grid mm
Input Voltage 100/240 VAC;
50/60 Hz
Maximum Input Current 1A
Maximum Output Current Rechargeable Lithium-Polymer:
12.6 VDC
Rechargeable Lithium-Ion Standard:
16.0 VDC
Rechargeable Lithium-Ion Plus:
16.0 VDC
Output Current 800 mA

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Defibrillation Specifications

Input impedance > 10 MΩ

Frequency response 0.05 Hz to 100 Hz
Filters Electric mains:
Notch 60 - 50 Hz
Muscular:
Notch 35 Hz
Impedance detection range 25 Ω to 300 Ω
Gains 5 - 10 - 20 mm/mV
Beat reading range 10 BPM to 300 BPM
Tolerance ± 3%
Output Analog ECG signal 1V/mVPP
Calibration signal 1 mVPP ± 3%
Shock application By means of multifunctional adhesive
pads
Limits for defibrillation Adult:
150 J;
200 J (optional);
360 J (optional)
Child:
50 J;
70 J (optional);
85 J (optional)
Area of the Shock Pads Adult:
88.30 cm2
Child:
38.46 cm2
Length of the Cable of the 2m
Shock Pads
Adult/Child Selection Automatic by type of pads
Defibrillator Output Features 1.5 KV Max;
50 A Max
Maximum Time from Start of Less than 20 seconds
ECG Analysis to Readiness for
Discharge at Maximum Energy
Capacitor Charging Time 50 Joules:
3 seconds
150 Joules:

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 4 seconds
200 Joules:
6 seconds
Maximum Time from Start of Less than 30 seconds
Operation to Readiness for
Discharge at Maximum Energy
(360 J)
Time to charge of the battery 20 minutes
(fully discharged) with mains
voltage at 90% to be able to
deliver 6 shocks of 200 J
Waveform Biphasic truncated exponential.
Waveform parameters adjusted as a
function of patient impedance.
Discharge Time < 240 ms
Non-Shockable Arrhythmias Atrial Fibrillation (AF);
Premature Atrial Contraction (PAC);
Premature Ventricular Contraction
(PVC);
Premature Ventricular Contraction with
R on T (PVC_RonT);
Multifocal Premature Ventricular
Contraction (mfPVC);
Supraventricular Tachyarrhythmia
(SVTa);
2nd Degree Atrioventricular Block
(BLKII);
Right Bundle Branch Blockade
(RBBB);
Bigemia; and
Asystole
Shockable Arrhythmias Ventricular Fibrillation (VF);
Fine Ventricular Fibrillation (FVF);
Coarse Ventricular Fibrillation (CVF);
Ventricular Tachycardia (VT);
Multifocal Ventricular Tachycardia (MVT);
and
Polyfocal Ventricular Tachycardia (PVT)

Oximetry Specifications

Pulse Reading Range 10 BPM to 300 BPM

Tolerance ± 2%
Resolution 1 BPM

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 SpO2 Reading Range 0% to 100%
Tolerance 70% to 100% Saturation for Finger Clip:
± 2 digits
70% to 95% Saturation for Neonatal:
± 3 digits
Saturatiton < 70%:
Undefined for all sensors
Scan 25 mm/s
Update Reading Time 5 seconds

ECG Specifications

Leads DII
ECG Cables 3 Way
Input impedance > 10 MΩ

Frequency Response Monitor:

0.5 Hz to 25 Hz
Diagnosis:
0.05 Hz to 100 Hz
Rejection In common mode greater than 90 dB
Sensitivity ECG amplification step, 5, 10, 15, 20,
30 and 40 mm/mV

Filters Electric mains:

Notch 60/50 Hz
Muscular:
Notch 35 Hz
Gains 5 - 10 - 20 mm/mV
Beat Reading Range 10 BPM to 300 BPM;
Accuracy of 1 BPM with numeric
presentation
Tolerance ± 3%
Output Analog ECG signal 1V/mVPP
Offset (Potential) ± 300 mV

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 Leak Currentt < 10 µA
Baseline Recovery ≤ 4s after defibrillation
Systolic Indicator (QRS) Audible beep
Calibration Signal 1 mVPP ± 3%
Operation Mode Continuous operation
Internal Pacemaker Pulse Detects the pacemaker pulse and
rejects the pulse.
Synchronism Does not synchronize shock with QRS.
According to arrhythmia algorithm, this
product indicates treatment in arrhythmias
where the QRS complex is not identified.
Does not display synchronism detection
indicators on the screen.
Maximum Delay Time between Does not synchronize shock with QRS.
Pulse Synchronization and According to arrhythmia algorithm, this
Energy Delivery product indicates treatment in arrhythmias
(After Output Activation) where the QRS complex is not identified.
Once the output has been activated, power
is readily delivered.
Situations that May Disable This equipment does not synchronize shock
Synchronism with QRS.

Feedback Device Specifications for CPR

Cabinet ABS Plastic; and

Rubber

Dimensions 105 mm x 74 mm x 10.5 mm

Cable Length 1.30 m

Duration of CPR Cycle 2 minutes

Frequency of Compressions 100 to 120 compressions/min

Depth of Compressions Adult:

5 cm to 6 cm

Maximum Interruption of 10 seconds

Compressions

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 C
APPENDIX C

APPLIED TECHNOLOGY

Heart Rhythm Detector

The Life 400 FUTURA Defibrillator - AED is prepared to recognize and indicate defibrillation
to the heart rhythms of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF),
AUTOMATICALLY, leaving the operator to connect the pads to the patient's chest and follow
their voice and text commands.

Recording Methods
Arrhythmias capable of defibrillation (VT and VF) are pre-programmed in the equipment,
eliminating the need for operator configuration, resulting in a significant gain in treatment
time.

Rhythm Selection Criteria

The selected rhythms are those notoriously known as the classic indication for defibrillation,
namely: ventricular fibrillation and ventricular tachycardia.

Annotation Methods
The Life 400 FUTURA Defibrillator – AED is equipped with a liquid crystal display, or a color
display (optional), where emergency care procedures and ECG tracings are plotted, allowing
the graphic recording of heart rhythms.

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Detector Performance Assessment Method

Rhythm Classification
Ventricular Tachycardia A
Ventricular fibrillation A+B

True Positive (A): Correct classification of rhythm susceptible of being

defibrillated

False Negative (B): Organized or perfused rhythm or asystole that has been
incorrectly classified as a rhythm susceptible of being
defibrillated

Shock Application as a Function of Impedance

< 25 Ω (and Short Circuit) Prevents application of shock

25 Ω to 300 Ω Allows application of shock

> 300 Ω (and Open Pads) Prevents application of shock

Truncated Exponential Biphasic Waveform

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Variations According to the Patient's Thoracic Impedance

Impedance (Ω) Phase A (ms) Phase B (ms)

25 5 3.3
30 6 4
40 8 5.3
50 10 6.7
> 60 12 8

OBSERVATION: Phase B corresponds to 2/3 of phase A

Maximum width (A+B+C): 20 ms
Dead-time (C): 0.5 ms

Selected Impedance (Ω)

Energy
(J) 25 50 75 100 125 150 175
50 47.1 47.7 47.9 44.7 48.7 45.4 47.1
150 145.8 148.9 147.1 147.5 142.5 138.1 131.8
200 182.6 187.5 191.1 180.5 197.5 183.8 199.7
Energy Delivered (J)

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 D
APPENDIX D

ELECTROMAGNETIC EMISSIONS
CLASSIFICIATION AND COMPLIANCE WITH REGULATORY
REQUIREMENTS

OBSERVATION: The Life 400 Futura Defibrillator is designed to operate in any environment shown below. The owner or operator of this
Equipment must use it in one of these environments.

ELECTROMAGNETIC ENVIRONMENT -
TEST COMPLIANCE
GUIDANCE

The LIFE 400 FUTURA DEFIBRILLATOR –

AED uses RF energy exclusively for its
RF Emissions
Group 1 internal functions. Thus, its RF emission is
CISPR 11
very low and is not likely to cause any
interference to nearby electronic equipment.

RF emissions CISPR
Class B
11

The Life 400 FUTURA Defibrillator – AED is

suitable for use in all residential
Harmonics Emissions establishments and those directly connected
Not Applicable
IEC 61000-3-2 to the public low-voltage electricity distribution
network that supplies buildings for domestic
use.
Voltage fluctuations /
scintillation emission Not Applicable
IEC 61000-3-3

Interference Resistance Test

APPLIED ELECTROMAGNETIC
TEST COMPLIANCE
LEVEL ENVIRONMENT - GUIDANCE

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SGQ - 27/10/2022 15:52

 ± 2kV, ± 4
Floors must be made of wood or
kV and ±
cement, and must have ceramic
Electrical discharge 6kV by
tiles.
(lightning) contact
Conform If the floor is made of synthetic
Static (ESD) according
material,
to IEC 61000-4-2 ± 2kV, ± 4
relative humidity must be at least
kV and ±
30%
8kV by air

±2 kV on
Fast transient
power
electrical disturbances
supply lines
/ discharges Conform
±1 kV on
according to
input/output
IEC 61000-4-4 Power supply quality should match
lines
the voltage supplied in a typical
± 1 kV commercial or hospital environment.
differential
Overvoltages
mode
according to IEC Conform
± 2 kV
61000-4-5
common
mode
< 5% Ut
(>95%
voltage
drop in Ut)
for 0.5
cycle.
The quality of the supplied voltage
40% Ut
must correspond to the voltage
(60%
Supplied in a
voltage
typical commercial or hospital
Voltage drops, drop in Ut)
environment. If the user of the LIFE
Brief interruptions and for 5 cycles.
400 FUTURA DEFIBRILLATOR -
Voltage fluctuations
Conform AED requires continuous operation
Provided in 70% Ut
even when there are interruptions in
accordance with IEC (30%
the energy supply, the
61000-4-11 voltage
LIFE 400 FUTURA
drop in Ut)
DEFIBRILLATOR – AED must be
for 25
powered without interruptions or with
cycles.
a battery.
< 5% Ut
(> 95%
voltage
drop in Ut)
for 5
seconds.

Magnetic fields at the power

Magnetic field at
frequency should be at levels
supply frequency
30 A/m Conform characteristic of a typical location in
(50/60 Hz) according to
a typical commercial or hospital
IEC 61000-4-8
environment.

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 Portable and mobile RF
communication equipment should
not be used near any part of the
LIFE 400 FUTURA
DEFIBRILLATOR - AED, including
cables, with a separation distance
less than the recommended one, this
safe distance will be calculated from
the equation applicable to the
frequency of the transmitter.
Recommended Separation Distance:

3 VRMS in d = [3.5 / V1] √P

RF Conducted entire [V1] V
IEC 61000-4-6 range/ Conform d = [3.5 / E1] √P 80 MHz to 800Mhz
6 VRMS
At the freq. d = [7/E1] √P 800 MHz up to 2.5 Ghz
ISM.
150 kHz up where P is the rated maximum
to 80 MHz output power of the transmitter in
Watts (W), according to the
transmitter manufacturer, and d is
RF Radiated 10 V/m [E1] V/m the recommended separation
IEC 61000-4-3 80 MHz up Conform distance in meters (m)
to 2.7 GHz
It is recommended that the field
strength established by the RF
transmitter, as determined through
an electromagnetic on-site
inspection a, be less than the
compliance level in each frequency
range.

Interference may occur around

equipment marked with the following

symbol:
Note 1 Test levels defined according to ABNT NBR IEC 60601 guidelines.
Note 2 Ut is the AC supply voltage before the test level is applied
Note 3 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

a Field intensities established by fixed transmitters, such as base stations, wireless (cellular) telephone and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with precision. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey is recommended. If
the field strength measurement at the location where the LIFE 400 FUTURA DEFIBRILLATOR - AED is used exceeds the
compliance level used above, the LIFE 400 FUTURA DEFIBRILLATOR - AED should be observed to verify if the
operation is normal. If abnormal performance is observed, additional procedures may be necessary, such as reorienting
or relocating the LIFE 400 FUTURA DEFIBRILLATOR - AED.
b Over the frequency range 150 kHz to 80 MHz, the field intensity should be less than [V1] V/m.

The Life 400 Futura Defibrillator does not have intentional electromagnetic interference.

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 TECHNICAL ASSISTANCE
CMOS DRAKE DO NORDESTE S.A
TECHNICAL ASSISTANCE
CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

Mr./Mrs. Proprietor,
CMOS DRAKE DO NORDESTE LTDA
Cmos Drake do Nordeste has a large list of representatives and technical assistance
CMOS DRAKE DO NORDESTE LTDA
throughout the Brazilian territory.
So that we can provide you with a personalized service, we ask that you send us the
CMOS DRAKE DO NORDESTE LTDA
registration form on the next page, for updates on our database and better guidance of
authorized technical assistance
CMOSservices
DRAKE DOfor each region LTDA
NORDESTE of Brazil, training and others.
Within Brazil, for additional information about the product or for any need to use the network
of authorized workshops,CMOS complaints,
DRAKE DOdoubts, suggestions,
NORDESTE LTDA and technical assistance,
contact our Customer Service below:
CMOS DRAKE DO NORDESTE LTDA
Site www.cmosdrake.com.br
CMOS DRAKE DO NORDESTE LTDA
Telephone (0XX31) 3547-3969
CMOS DRAKE DO NORDESTE LTDA
E-mail [email protected]
CMOS DRAKEAv.
Address DORegent
NORDESTE
600, LTDA
Sala 205
DistrictCMOS DRAKEAlphaville,
DO NORDESTELagoaLTDA
dos Ingleses
City / State Nova Lima, MG
CMOS DRAKE DO NORDESTE LTDA
Zip Code 34.018-000
CMOS DRAKE DO NORDESTE LTDA
Office Hours Monday to Friday, 08:00 AM -
CMOS DRAKE06:00
DO NORDESTE
PM LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS
In special cases that are DRAKE DOCMOS
necessary, NORDESTE
DRAKELTDA
makes available, by agreement, all
technical material such as circuit diagrams, list of materials, technical information,
component lists, instructions for calibration and gauging or whatever is necessary to
CMOS DRAKE DO NORDESTE LTDA
that user-qualified technical personnel can carry out repairs on the parts designated
repairable by the manufacturer. Authorization for maintenance must be formally
expressed by CMOS CMOS DRAKE DO NORDESTE LTDA
DRAKE.

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

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SGQ - 27/10/2022 15:52
 REGISTRATION FORM
CMOS DRAKE DO NORDESTE LTDA
REGISTRATION FORM
CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

Mr./Mrs. Proprietor,
CMOS DRAKE DO NORDESTE LTDA
Please fill in the fields below with your updated data and send it to us by fax so that we can
register you in our system. CMOS
ThisDRAKE DO NORDESTE
is necessary LTDA
in order to provide the best service to our
customers, keeping all contacts up to date for inquiries and technical assistance.
CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

EQUIPMENT SERIAL NUMBER
CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

LIFE 400 FUTURA DEFIBRILLATOR
CMOS DRAKE DO NORDESTE LTDA
CUSTOMER NAME
CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

ADDRESS
CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CITY STATE
CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

TELEPHONE CMOS DRAKE DO NORDESTE

FAX LTDA
CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

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CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

SGQ - 27/10/2022 15:52
 MAINTENANCE CHECKLIST
CMOS DRAKE DO NORDESTE LTDA
MAINTENANCE CHECKLIST
CMOS DRAKE DO NORDESTE LTDA
Equipment StartLTDA
Date / /
CMOS DRAKE DO NORDESTE
Serial Number
Location End Date / /
CMOS DRAKE DO NORDESTE LTDA

CMOS
This checklist allows 7 daysDRAKE DOa VNORDESTE
of test. Insert LTDA
in the field Day for each concluded instruction
Day
Instruction Recommended Corrective Action
CMOS DRAKE DO NORDESTE1 LTDA
2 3 4 5 6 7
Check if the Equipment
cabinet has foreign CMOS
Clean DRAKE DO NORDESTE LTDA
the Equipment
substances
Check the Equipment CMOS DRAKE DO NORDESTE LTDA
Contact the Qualified Technical
cabinet for damage or
Assistance
cracks CMOS DRAKE DO NORDESTE LTDA
Check the chargers connections
Connect the Equipment to
the electric mains. Check if CMOS
with DRAKEand
the Equipment DOtheNORDESTE
electric LTDA
mains. If the problem persists,
the charger’s LED does
contact the Authorized Technical
not light up CMOS DRAKE DO NORDESTE LTDA
Assistance.

Check if the disposable CMOS DRAKE DO NORDESTE LTDA

shock pads are out of the Replace the shock pads
expiry date
CMOS DRAKE DO NORDESTE LTDA
Check if there are spare
Replace the electrodes
electrodes available CMOS DRAKE DO NORDESTE LTDA
Check if the cables and
pins of the Accessories CMOSthe
Replace DRAKE
damagedDO NORDESTE LTDA
parts
have damages or cracks
CMOS DRAKE DO NORDESTE LTDA
Disconnect the Equipment
Recharge or replace the battery. If
from the electric mains and
the battery cannot maintain the
turn it on. Check if the CMOS DRAKE DO NORDESTE LTDA
charge, contact the Qualified
battery charge level is
Technical Assistance.
low
CMOS DRAKE DO NORDESTE LTDA

RECOMMENDATION CMOS DRAKE DO NORDESTE LTDA

It is recommended that this device be inspected and tested daily according to checklist.
CMOS DRAKE DO NORDESTE LTDA
WARNING
CMOS DRAKE DO NORDESTE LTDA
Possibility of damage to the Equipment:
Do not clean any part of this Equipment or its Accessories with bleach, bleach dilution or
CMOS DRAKE DO NORDESTE LTDA
phenol-based chemical compounds.
Do not use abrasive or flammable cleaning agents. Do not attempt to sterilize this Equipment
or any of its Accessories. CMOS DRAKE DO NORDESTE LTDA
CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

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CMOS DRAKE DO NORDESTE LTDA

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SGQ - 27/10/2022 15:52
 CERTIFICATE OF
CMOS DRAKE DO NORDESTE S.A
WARRANTY
CMOS DRAKE DO NORDESTE LTDA
CERTIFICATE OF
CMOS DRAKE DO NORDESTE S.A guarantees Legal Warranty against any manufacturing defect for a period
of 12 (twelve) months from theCMOS
date of DRAKE
issuance DO NORDESTE
of the sales invoiceLTDA
referring to the equipment purchased by
WARRANTY
the consumer with mandatory identification of the model, serial number and equipment characteristics. CMOS
DRAKE do NORDESTE S.A does CMOS DRAKE
not grant DO NORDESTE
any form LTDA
or type of warranty for equipment unaccompanied by the
sales invoice to the consumer.
CMOS DRAKE DO NORDESTE LTDA
Scope of Warranty
CMOS DRAKE DO NORDESTE LTDA
• Any defect diagnosed during the installation and (or) use of the product, the consumer must
immediately contact CMOS DRAKE DO NORDESTE S.A. The same will activate the Authorized
CMOS
representatives to provide DRAKE DO
the necessary NORDESTE LTDA
services.
• The Manufacturer will be responsible for replacing parts and components that present anomalies found
CMOSinDRAKE
to be manufacturing defects, DO
addition to theNORDESTE
labor involvedLTDA
in this process.
• Oximetry sensors and patient cables are warranted for ninety (90) days, except for misuse, physical
damage and/or breakage.CMOS DRAKE DO NORDESTE LTDA
• Consumable materials subject to natural wear and tear, such as batteries, disposable electrodes,
CMOS
among others, are excluded DRAKE
from DO NORDESTE LTDA
this warranty.
• This guarantee does not include any compensation for loss of profit, personal accidents and third
parties and other goods.
CMOS DRAKE DO NORDESTE LTDA
• This warranty term is valid only for products sold and installed in Brazilian territory.
CMOS DRAKE DO NORDESTE LTDA
Warranty Cancellation Conditions

• If the recommendations CMOS DRAKE in

contained DOthis
NORDESTE LTDA
manual regarding installation, operation, care,
recommendations and warnings are not followed.
• CMOSviolation
If there is a breakage and/or DRAKE of DO NORDESTE
the security seal. LTDA
• If there is removal or alteration of the serial number of the equipment purchased by the consumer.
• If the Equipment is usedCMOS DRAKE
with cables, DO NORDESTE
sensors, LTDA
accessories or consumables that are not original
CMOS DRAKE or outside the normal conditions of use, such as expiration date or period or use.
• CMOSwith,
If the Equipment is tampered DRAKE DO NORDESTE
calibrated, LTDA
adjusted, repaired or tampered with by professionals
not Authorized by the Manufacturer.
• If the Equipment is usedCMOS DRAKE
in a manner from that described
DO NORDESTE
different LTDA in the USER’S MANUAL.
• If the Equipment is damaged by accidents such as falling, knocking, misuse, neglect or natural
phenomena.
CMOS DRAKE DO NORDESTE LTDA
Disclaimer
CMOS DRAKE DO NORDESTE LTDA
The Manufacturer is not responsible for expenses with installations, products or accessories damaged due to
transport accidents, handling, CMOS DRAKE
scratches, dents,DO NORDESTEorLTDA
non-functioning failures resulting from problems in the
electricity supply. In locations where there is no authorized technical assistance from CMOS DRAKE, the costs
of transporting the device to the CMOS DRAKE
factory or the DO NORDESTE
authorized LTDA
technician to the place where the equipment is
located will be borne by the Consumer requesting the service according to a previously approved budget. The
Manufacturer is not responsibleCMOS DRAKE
for improper useDO NORDESTE
and/or LTDA persons.
use by unqualified

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

Serial Number: CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA

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CMOS DRAKE DO NORDESTE LTDA

CMOS DRAKE DO NORDESTE LTDA SGQ - 27/10/2022 15:52

 CMOS DRAKE DO NORDESTE S.A
AV. REGENT 600, SALA 205; TÉRREO E 1º ANDAR
B. ALPHAVILLE, LAGOA DOS INGLESES
NOVA LIMA – MG – CEP: 34,018-000 – (0XX31) 3547-3969
TECHNICAL HEAD: BÁRBARA HELEN SOUZA MAIA
CREA/MG: 224055-D
LEGAL REPRESENTATIVE: MARCO AURÉLIO MARQUES FÉLIX

This manual was prepared by the Engineering and Quality departments of CMOS DRAKE,
and approved by the Inmetro Certification Body.

Reproduction of this publication in any form transmitted or stored in a retrieval system is

prohibited. Through electronic, recording or other means, without the proper written
authorization of CMOS DRAKE.

CMOS DRAKE reserves the right to make any changes it deems necessary to the manual
or product without any prior notice to the consumer. Any and all alterations/modifications
are communicated to Inmetro and Anvisa.

MADE IN BRAZIL
CNPJ [Corporate Taxpayer ID Number]: 03.620.716/0001-80

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