CareFusion BabyCO Operating Manual

BabyCO Meter

Operating Manual –

English

Benutzerhandbuch –

Deutsch

Manual de funcionamiento –

Español

Manual de Operação –

Português

Gebruiksaanwijzing –

Nederlands

Manuale operativo –

Italiano

Руководство пользователя,

русский язык



-

简

Simplified

1

Contents

Overview ........................................................................ 9

I. Introduction - English ................................................... 9

Cigarette Consumption and CO Measurements ...................10

Package Contents ...........................................................12

Contraindications ............................................................13

Warnings and Cautions ....................................................13

Intended Use .................................................................14

Operation ......................................................................15

PC Connection ................................................................17

Calibration .....................................................................18

Battery Life ....................................................................22

Battery Replacement .......................................................22

Internal Battery Expiry ....................................................23

Sensor Expiry .................................................................24

Cleaning ........................................................................25

Servicing .......................................................................26

Trouble Shooting Information ...........................................26

Safety Designation per IEC 60601-1 .................................27

Electromagnetic Compatibility (EMC) to

EN60601-1-2:2007 .........................................................28

Symbols ........................................................................33

Specifications .................................................................34

Consumables / Accessories ..............................................35

Customer contact information ..........................................37

Übersicht .......................................................................41

II. Einleitung - Deutsch ................................................... 41

Zigarettenkonsum und CO-Messungen ..............................42

2

Lieferumfang ..................................................................44

Kontraindikationen ..........................................................46

Warn- und Vorsichtshinweise ...........................................46

Verwendungszweck .........................................................47

Betrieb ..........................................................................49

PC-Anschluss .................................................................52

Kalibrier- .......................................................................52

Batterielebensdauer ........................................................57

Batteriewechsel ..............................................................57

Haltbarkeit der internen Batterie .......................................58

Haltbarkeit des Sensors ...................................................59

Reinigung ......................................................................60

Wartung ........................................................................62

Informationen zur Fehlerbehebung ...................................62

Sicherheitsbezeichnung gemäß IEC 60601-1 ......................63

Elektromagnetische Verträglichkeit (EMV) gemäß

EN60601-1-2:2007 .........................................................65

Symbole ........................................................................70

Technische Daten ...........................................................71

Verbrauchsartikel/Zubehör ...............................................73

Kundenkontaktdaten .......................................................75

General .........................................................................79

III. Introducción - Español ................................................ 79

Consumo de cigarrillos y medición de CO ...........................80

Contenido del paquete .....................................................82

Contraindicaciones ..........................................................83

Advertencias y precauciones ............................................83

Uso previsto ...................................................................84

Funcionamiento ..............................................................85

3

Conexión al PC ...............................................................88

Calibración .....................................................................88

Duración de la batería .....................................................93

Sustitución de la batería ..................................................93

Caducidad de la batería interna ........................................94

Caducidad del sensor ......................................................95

Limpieza ........................................................................96

Mantenimiento ...............................................................97

Información de solución de problemas ...............................97

Designación de seguridad conforme a IEC 60601-1 .............98

Compatibilidad electromagnética (CEM) de acuerdo con

EN60601-1-2:2007 ....................................................... 100

Símbolos ..................................................................... 105

Especificaciones ............................................................ 106

Consumibles/Accesorios................................................. 108

Información de contacto del cliente ................................. 110

Visão Geral .................................................................. 113

IV. Introdução - Português ............................................ 113

Consumo de Cigarros e Medições de CO .......................... 114

Conteúdo da Embalagem ............................................... 116

Contraindicações .......................................................... 117

Avisos e Cuidados ......................................................... 117

Uso Pretendido ............................................................. 118

Funcionamento ............................................................. 119

Conexão ao PC ............................................................. 122

Interruptor ................................................................... 122

Duração da Bateria ....................................................... 127

Substituição da Bateria .................................................. 127

Vencimento da Bateria Interna ....................................... 128

4

Vencimento do Sensor ................................................... 129

Limpeza ....................................................................... 130

Manutenção ................................................................. 131

Informações sobre Resolução de Problemas ..................... 131

Designação de Segurança Segundo o IEC 60601-1 ........... 132

Compatibilidade Eletromagnética (CEM) de acordo com o

EN60601-1-2:2007 ....................................................... 133

Símbolos ..................................................................... 138

Especificações .............................................................. 139

Consumíveis/Acessórios ................................................. 140

Informações do cliente para contato ................................ 142

Overzicht ..................................................................... 145

V. Introductie - Nederlands .......................................... 145

Sigarettenconsumptie en CO-metingen ............................ 146

Inhoud verpakking ........................................................ 148

Contra-indicaties .......................................................... 149

Waarschuwingsberichten ............................................... 149

Bedoeld gebruik............................................................ 150

Bediening .................................................................... 151

Pc-aansluiting............................................................... 154

Kalibratie ..................................................................... 154

Gebruiksduur batterij .................................................... 159

Batterij vervangen ........................................................ 159

Interne batterij vervallen ............................................... 160

Sensor vervallen ........................................................... 161

Reinigen ...................................................................... 162

Service ........................................................................ 164

Problemen oplossen ...................................................... 164

Veiligheidsaanduiding volgens IEC 60601-1...................... 165

5

Elektromagnetische compatibiliteit (EMC) volgens

EN60601-1-2:2007 ....................................................... 167

Symbolen .................................................................... 172

Specificaties ................................................................. 173

Verbruiksartikelen/accessoires........................................ 175

Contactinformatie voor klanten ....................................... 177

Panoramica .................................................................. 181

VI. Introduzione - Italiano ............................................. 181

Consumo di sigarette e misurazioni di CO ........................ 182

Contenuto della confezione ............................................ 184

Controindicazioni .......................................................... 185

Avvertenze e precauzioni ............................................... 185

Uso previsto ................................................................. 186

Funzionamento ............................................................. 187

Collegamento a PC ........................................................ 190

Calibrazione ................................................................. 190

Durata utile della batteria .............................................. 195

Sostituzione della batteria .............................................. 195

Durata utile della batteria interna ................................... 196

Durata utile del sensore ................................................. 197

Pulizia ......................................................................... 198

Assistenza tecnica ......................................................... 199

Risoluzione guasti ......................................................... 199

Prescrizioni per la sicurezza secondo la direttiva

IEC 60601-1 ................................................................ 200

Compatibilità elettromagnetica (EMC) in conformità

con la norma EN60601-1-2:2007 .................................... 202

Simboli ........................................................................ 207

Specifiche .................................................................... 208

6

Consumabili/Accessori ................................................... 210

Informazioni di contatto per i clienti ................................ 212

Обзор ......................................................................... 215

VII. Введение - русский язык ........................................ 215

Курение сигарет и измерения CO .................................. 216

Комплект поставки ...................................................... 218

Противопоказания ....................................................... 220

Предупреждения и меры предосторожности .................. 220

Использование ............................................................ 222

Эксплуатация .............................................................. 223

Связь с ПК .................................................................. 226

Калибровка ................................................................. 226

Время работы от батарей ............................................. 231

Замена батареи ........................................................... 231

Истощение внутренней батареи .................................... 232

Окончание срока службы датчика ................................. 233

Очистка ...................................................................... 234

Сервис ........................................................................ 236

Информация о поиске и устранении неисправностей ..... 236

Описание безопасности по IEC 60601-1 ........................ 237

Электромагнитная совместимость (EMC) по

EN60601-1-2:2007 ....................................................... 239

Символы ..................................................................... 245

Технические характеристики ........................................ 246

Расходный материал/дополнительные

принадлежности .......................................................... 248

Контактная информация для клиентов .......................... 250

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概述

............................................................................. 253

VIII.

简介

简介简介

简介 ----简体中文

简体中文简体中文

简体中文

Simplified .............................................. 253

吸烟与一氧化碳测量

......................................................... 254

包装内容

....................................................................... 256

禁忌症

.......................................................................... 257

警告和小心

.................................................................... 257

设计用途

....................................................................... 258

操作

............................................................................. 259

个人

计算机连接

............................................................... 261

定标............................................................................. 261

电池寿命

....................................................................... 265

更

换电池

....................................................................... 265

内置

电池寿命

................................................................. 266

传感器寿命

.................................................................... 266

清洗

............................................................................. 267

维修

............................................................................. 268

故障

诊断信息

................................................................. 268

根据

IEC 60601-1

的安全指示

........................................... 269

符合

EN60601-1:2007 的电磁兼容性

(EMC) ........................ 270

符号

............................................................................. 274

规格

............................................................................. 275

消耗品/配件

................................................................... 276

客

户联系信息

................................................................. 278

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9

BabyCO Meter

Operating manual

Overview

The BabyCO meter is a hand held battery operated device used to
measure the concentration of carbon monoxide, CO, on the breath
and calculates the percentage of carboxyhaemoglobin, FCOHb, in the
foetal blood.

It is accurate, easy to use, and has many features designed to
simplify its operation.

These include: Auto zero function
Smoking level colour
light indicators
Simple calibration
Serial interface to PC

Please note: It is recommended that this unit be calibrated
upon receipt.

I. Introduction - English

The BabyCO meter is based on an electrochemical fuel cell sensor,
which works through the reaction of carbon monoxide (CO) with an
electrolyte at one electrode, and oxygen (from ambient air) at the
other. This reaction generates an electrical current proportional to
CO concentration. Output from the sensor is monitored by a
microprocessor, which detects peak expired concentrations of
alveolar gas. This is then converted to % foetal carboxyhaemoglobin
(%FCOHb) using the relationship %FCOHb = 0.313*Expired CO

10

(ppm). This relationship is derived from data supplied by the Centre
Hospitalier d’Arras, Maternité Georges Pernin, Arras, France1. The
results are displayed on a clear LCD display.

Warning lights are provided to give an instant indication of the
smoking level.

The warning light levels are user adjustable when the unit is
connected to a PC running COBRA software.

References

1. Gomez C, Berlin I, Marquis P, Delcroix M.

Expired air carbon monoxide concentration in mothers
and their spouses above 5 ppm is associated with
decreased foetal growth.

Preventative Medicine 40 (2005) 10-15

Cigarette Consumption and CO Measurements

The BabyCO meter provides a simple screening test for cigarette
consumption for use in anti-smoking clinics and all smoking
cessation programs.

Measurement of carboxyhaemoglobin has been well validated as an
indirect measure of cigarette consumption and is widely used in
smoking cessation programs.

Typical values for carboxyhaemoglobin and expired CO in smokers
together with the alarm light status, are given below:

CO(ppm) Cigarette consumption Indicator

0 – 6 Non smoker Green

7 – 10 Light smoker Amber

11 - 20 Heavy smoker Red

11

20+ Heavy smoker Flashing red with

alarm

Please note that some urban areas may have high environmental
levels of CO. This can cause a rise in exhaled CO of a few ppm
above that which is normally present on the breath. In these cases
it is possible for a non-smoker to appear at the bottom of the ‘light
smoker’ range (7 – 10 ppm).

The above table applies when the unit is measuring expired CO with
the switch in middle position. When measuring FCOHb, with the
switch in the top position, the red indicator will illuminate whenever
the expired CO measurement is 7 ppm and above.

References

1. Carbon monoxide in breath in relation to smoking and
carboxyhemaglobin levels.

Wald NJ, Idle M, Boreham J, Baily A
Thorax 1981; 36, 366-369

2. Definition of a reliable threshold value for detecting

current smokers by CO measurement

Marino Luigi; Latini Roberto; Barbano Gina; Bazzerla Giorgio;
De Luca Anita, Nardini Stefano - Respiratory and TB Unit­General Hospital- Via forlanini, 71-I-31029-Vittorio Veneto (TV­ITALY).

12

Package Contents

The BabyCO meter is supplied with a carrying case containing the
following items:

1. BabyCO meter (Cat No. 36-BC01-STK)

2. 22 mm mouthpiece adapter (Box of 10 Cat No.36-PSA2000)

3. 22 mm reducing connector for calibration (Cat No.36-MEC1007)

4. PP3 Battery (Cat No.36-BAT1002)

5. Disposable mouthpieces (Box 250 Cat No.36-PSA1200)

6. Calibration tool (Cat No. 36-MEC1184)

6

5

4

1

2

3

CO

FCOHb

OFF

13

Contraindications

There are no known contraindications, however it should be noted:

The BabyCO should not be used on individuals that may cause
discomfort exhaling at a sustained speed or exacerbate any
discomfort at the mouth by exhaling into a mouthpiece
Pregnant individuals should hold their breath for as long as they feel
comfortable to do so before exhaling into the device

Warnings and Cautions

The following terms are used as follows in this manual

Caution: Possibility of injury or serious damage
Warning: conditions or practices that could result in personal injury
Please Note: Important information for avoiding damage to the

instrument or facilitating operation of the instrument.

Note: The device should only be used by trained and qualified
personnel.

CAUTION: Read the manual before use

CAUTION: Do not attempt to charge the batteries, connect improperly,

or dispose of in a fire as there is possibility of leakage or explosion.
Follow manufacturer’s recommendation for proper disposal.
WARNING: The instrument is not suitable for use in the presence of
explosive or flammable gases, flammable anaesthetic mixtures or in
oxygen rich environments.
CAUTION: Mouthpieces are single patient use. If used on more than
one patient there is a risk of cross-infection. Repeat use may
degrade materials and lead to an incorrect measurement.

14

PLEASE NOTE: The product and the battery you have
purchased should not be disposed of as unsorted waste.
Please utilise your local WEEE collection facilities for the

disposal of this product.
PLEASE NOTE: Degree of protection against Ingress of Water is
IPX0.
CAUTION: When you connect the BabyCO to other equipment,
always make sure that the whole combination complies with the
international safety standard IEC 60601-1 for medical electrical
systems. During measurements, connect the BabyCO only to
computers that comply with IEC 60601-1 / ANSI/AAMI ES60601­1:2005 / CAN/CSA-C22.2 No. 60601-1:14.

Intended Use

The BabyCO is intended to measure the amount of Carbon Monoxide
(CO) that can be expired from the breath. The expired CO is
measured in parts per million and this can be used to calculate using
an algorithm the percentage of carboxyhaemoglobin, (%FCOHb), in
the foetal blood.

The BabyCO is used in smoking cessation clinics, GP’s surgeries and
antenatal clinics for instructional purposes and to check on the
client’s progress and compliance.

The BabyCO is designed for use by clinicians and health care
professionals

15

Operation

For accurate results the BabyCO meter should be used at room
temperature. If the instrument has been stored in cool or hot
conditions then allow time to reach room temperature prior to use.

Install the PP3 battery by sliding open the battery cover, clipping the
battery in place and replacing the cover. Insert the mouthpiece
adapter into the BabyCO meter and then insert a disposable
mouthpiece into the adapter. Turn the unit on by pushing the slide
switch to the middle position (CO). The display will show the
software version number momentarily whilst correction for ambient
levels is executed. During this time the unit must not be exposed to
any source of CO. The buzzer will then sound and the display will
change to:

BLOW

Upon hearing the buzzer instruct the subject to inspire fully and hold
their breath for as long as is comfortable. The breath-holding period
is recommended to allow time for equilibration of alveolar gas.

The subject should then seal their lips around the mouthpiece and
exhale slowly and fully.

After emptying the lungs completely the display will show the
expired CO concentration in the expired air in parts per million
(ppm):

16

CO

ppm

Provided the subject is not too distressed after seeing the breath CO
measurement, then the calculated foetal carboxyhemaglobin level
may be displayed by pushing the slide switch to the top position
(FCOHb):

FCOHb

%

The unit must not be used, however, for one second after the unit is
first switched on i.e. before the display shows ‘BLOW’. Expired
alveolar gas is then entrapped between sensor and mouthpiece
valve. The display reading will rise to a plateau over the course of
several seconds. The final value will be held until the unit is turned
off and represents parts per million CO or %FCOHb depending on
the slide switch position.

The lights will come on according to the table on page 10.

Important note:
Before repeating a measurement the unit must be turned off,
and the mouthpiece and adapter removed for at least 1
minute. This is to allow re-equilibration with ambient air and
to dry the surface of the sensor. Visually inspect that all

17

moisture has evaporated from the surface of the sensor
before reuse.

If the unit is switched on again too quickly after use there may be a
response to residual expired carbon monoxide from the previous
test.

In this case the display will show:

If this is displayed then turn the unit off, remove the mouthpiece
adapter, and expose to ambient air for 2 minutes before repeating
the test.

Note: If this warning appears again after following the above
procedure then turn off and leave the sensor exposed to ambient air
for a further 3 minutes. If the same message appears again then
this indicates possible contamination of the sensor with a solvent.

In this case remove all sources of solvent from the vicinity of the
sensor and expose to ambient air for 24 hours before switching on
again.

PC Connection

The BabyCO meter may be connected to the serial port of a PC
running COBRA (CO Breath Analysis) software.

This software allows the measurements to be read by a PC and
automatically entered onto a pre-defined report for subsequent
printing and filing. It also allows the CO level indicators and the

18

breath holding countdown timer to be configured to individual
requirements.

Note: The BabyCO should only be connected to a computer that is
manufactured in accordance with EN 60601-1.

Note: Keep the PC out of reach of the patient at all times.

Calibration

Calibration will remain stable to within 2% over one month and
typically to within 10% over 6 months. CareFusion supplies
calibration gas (20ppm CO in air) and recommends that the unit be
recalibrated on a 6 monthly basis. See page 35 for calibration
accessories.
The gas is supplied in convenient, disposable, aluminium aerosol
cans (Cat. No.36-MCG020).

To carry out the calibration locate the calibration switch on the right­hand side of the instrument as shown below.

Serial

port

Calibration

Switch

19

Push the slide switch to the CO - PPM position and wait for the unit
to display zero.

Screw the control valve firmly onto the cylinder and connect the gas
supply as shown below:

carbon monoxide

in air

Flow
Indicator

Control

Valve

Reducing connector for
for Calibration

Plastic Tubing

20

The plastic tubing supplied with the gas should be pushed firmly
over the reducing connector.

Slowly turn the control knob anti-clockwise until the ball in the flow
indicator is between the two marks. This will then supply a gas flow
of approximately 0.25 l/min. Apply this flow for 25 seconds and if
the meter does not read 20ppm use the calibration tool to push the
calibration switch.

The unit will then beep 3 times, store the new calibration value, and
display the following:

The gas supply should then be turned off.

If the signal from the CO sensor is too low a new calibration value
will not be stored and the display will show:

The most likely cause for this is an expired cell but may also be
caused by depressing the calibration switch with no gas applied.
Ensure that the concentration of calibration gas is correct (20ppm),
that the connections to the gas cylinder are secure, and that the gas
cylinder is not empty, and then repeat the calibration procedure.

21

If the above message is repeated, the BabyCO meter must be
returned to CareFusion Ltd, or an authorised agent, for sensor
replacement.

Sensor life greater than 2 years. The sensor life depends upon both
the amount of exposure to CO and other gases, particularly solvents
such as alcohol and cleaning fluids.

If the signal from the CO sensor is too high, a new calibration value
will not be stored and the following will be displayed when
calibration is attempted:

The most likely cause for this is using an incorrect concentration of
calibration gas. Ensure that the concentration of calibration gas is
correct (20ppm), that the connections to the gas cylinder are
secure, and then repeat the calibration procedure.

In order to stop any gas leak from the can after calibration, ensure
that the control knob is tightened firmly.

Important Notes:

• Only certified calibration gas from a reputable source should be

used.

• Ensure that no CO is present on the sensor for 3 minutes before

starting the calibration procedure.

• Ensure that the instrument and gas cylinder have stabilised at

room temperature before calibrating.

22

• In order to stop any gas leak from the can after calibration,

ensure that the control knob is tightened firmly.

Battery Life

Battery life is approximately 30 hours of continuous use.
When the battery has approximately 1 hour of useful life left the
alarm will sound momentarily after the unit is first switched on and
the following message will be displayed:

When the battery has completely expired the above will be displayed
continuously and the battery must be replaced.

Battery Replacement

Locate the sliding cover situated on the rear of the unit, towards the
bottom of the device.

Place your thumb over the round thumb indent, press gently and
slide the cover to the right to remove it from the unit.

Lift the old battery out, and holding the battery terminal by the
plastic body, pull it off the old battery.

Plug the new battery into the battery terminal, taking care that the
correct polarity is observed.

Push the battery back into the battery holder, and replace the
battery cover onto the guides. Slide the battery cover to the left
until it is fully home.

23

Note: Please remove the battery if the meter is likely to be unused
for some time.

CAUTION: Do not open the battery cover when the device is
turned on.

CAUTION: The operator should not touch the contacts of the
battery and the patient at the same time.

Please Note: Dispose of the waste battery in accordance with EU
Waste Battery Regulations.

Internal Battery Expiry

The BabyCO meter has an internal battery with a life of
approximately 10 years. This battery supplies the sensor signal
conditioning circuit continuously to ensure instant start up.

When the battery has expired, the following warning message will be
displayed:

and the alarm will sound when the unit is first turned on.

When this occurs, the BabyCO meter must be returned to
CareFusion, or an authorised agent, for battery replacement.

24

Sensor Expiry

Sensor life greater than 2 years. The sensor life depends upon both
the amount of exposure to CO and other gases and solvents such as
alcohol and cleaning fluids.

When the sensor has expired it will become impossible to obtain a
correct calibration. When this occurs, the Baby CO must be returned
to CareFusion or an authorised agent, for sensor replacement.

Product Lifetime

The BabyCO meter is designed for a product lifetime of 7 years.

25

Cleaning

Disinfection of contaminated parts is only effective after having them
carefully pre-cleaned. CareFusion recommend the tested solution of
PeraSafe sterilizing powder (36-SSC5000A) for pre-cleaning and
disinfection. If a different solution is used, please follow the given
manufacturer’s instructions.

CAUTION: Switch off the device and always unplug your BabyCO
meter from the computer before cleaning.

When using the disposable cardboard mouthpiece with one-way
valve under the prerequisite that the patient was instructed only to
exhale, the mouthpiece adapter and the CO meter surface have to
be cleaned.

The mouthpiece adapter may be cleaned and sterilised by immersion
in Perasafe (36-SSC5000A) or other cold sterilising solutions.
Exposed surfaces of the meter may be wiped with a clean, damp
cloth or a cloth that has been immersed in a sterilising solution. It is
recommended that this procedure is performed after each use and
all used cardboard mouthpieces discarded.

Important note: The sensor surface must not be wiped with any
aqueous solutions and must not be exposed to solvents e.g. alcohol
or permanent damage may result

CAUTION: Do not attempt to wash or immerse the BabyCO meter
in water or cleaning fluid, as there are electronic components inside
that will be permanently damaged.

Important note: Cardboard mouthpieces must be disposed off
immediately after the use.
If there are changes on the material surfaces of either the unit or
mouthpiece adaptor (cracks, brittleness) the respective parts must
be disposed off.

26

Servicing

If your unit requires service or repair please see page 37 for contact
details. A full service manual including circuit diagram and parts list
is available upon request.

Trouble Shooting Information

Should you encounter problems operating your BabyCO meter,
please consult the table below:

Problem Possible Cause Solution

BabyCO cannot be
switched on or “bat”
is displayed

Batteries are flat Change the battery

Battery life is
shorter than
expected

Unit not being
switched off

Turn the unit off after
use

“CEL” is displayed Fuel cell is

depleted

Return unit for cell
replacement

“Err” is displayed Gas cylinder empty Check valve on cylinder

for contents and replace
cylinder if necessary

Check the calibration
value on the cylinder is
20ppm.

“bt2” is displayed Internal battery

has expired

Return unit for battery
replacement

“gAS” is displayed Fuel cell is

depleted

Return unit for cell
replacement

Fuel cell is
contaminated by
residual gas or
solvents

Allow unit to be
exposed to clean air.
Turn unit ON and await
message to disappear,
if not return unit for cell
replacement.

27

Safety Designation per IEC 60601-1

Type of protection against
electrical shock

Internally powered
Equipment

Degree of protection against
electrical shock

Type B applied part

Power Equipment Battery type: PP3 battery,

Alkaline Manganese
Dioxide, 9.0V, 550mAh

Battery life: 2000 tests.
Degree of Electrical connection

between equipment and Patient

Equipment designed as
non-electrical connection to
the patient.

Degree of mobility Transportable
Mode of operation Continuous

Classification according to IEC 60601-1

BabyCO Meter Applied part, type B

WARNING: No modification of this equipment is allowed.

WARNING: Do not connect devices that are not specified as part of

the system.

NOTE: When you connect other equipment to the unit, always make
sure that the whole combination complies with the international
safety standard IEC 60601-1-1 for medical electrical systems. When
connecting to a PC with the supplied serial cable then the PC must
be IEC 60601-1 / ANSI/AAMI ES60601-1:2005 / CAN/CSA-C22.2
No. 60601-1:14 compliant.

WARNING: The user must not touch any voltage-carrying parts and
the patient at the same time.

28

Electromagnetic Compatibility (EMC) to EN60601­1-2:2007

WARNING: use of portable phones or other radio frequency (RF)

emitting equipment near the system may cause unexpected or
adverse operation

The BabyCO has been tested to EN60601-1-2:2007, regarding it’s ability to
operate in an environment containing other electrical/electronic equipment
(including other medical devices).

The purpose of this testing is to ensure that the BabyCO is not likely to
adversely affect the normal operation of other such equipment and that other
such equipment is not likely to adversely affect the normal operation of the
BabyCO.

Despite the testing of the BabyCO that has been undertaken, normal
operation of the BabyCO can be affected by other electrical/electronic
equipment and portable and mobile RF communications equipment.

As the BabyCO is medical equipment, special precautions are needed
regarding EMC (electromagnetic compatibility).

The BabyCo meter has an essential performance – the product should
continue to operate as intended, to an accuracy of +/- 5% of reading or
1ppm (whichever is greater)”

It is important that the BabyCO is configured and installed/put into service,
in accordance with the instructions/guidance provided herein and is used only
in the configuration as supplied.

Changes or modifications to the BabyCO may result in increased emissions or
decreased immunity of the BabyCO in relation to EMC performance.

The BabyCO should be used only with the PC serial cable provided by
Carefusion (Cat. No. 36-CAB1000, Description: Interface cable for COBRA
software). This cable should not be extended by the user. This cable should
not be used with devices other than the BabyCO. If the cable is extended by
the user, this may result in an increased level of emissions or decreased level
of immunity, in relation to the BabyCO’s EMC. Use of the cable with devices
other than the BabyCO, may result in an increased level of emissions or
decreased level of immunity, in relation to the other devices’s EMC.

WARNING:

The BabyCO should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use with other equipment is necessary, the
BabyCO and the other equipment should be observed / monitored, to verify
normal operation in the configuration in which it will be used.