Care Fusion BabyCO Meter User 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
操作手册 - 简体中文Simplified

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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

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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

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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

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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

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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

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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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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

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(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 Unit-
General Hospital- Via forlanini, 71-I-31029-Vittorio Veneto (TV-
ITALY).

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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

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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.

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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 ES60601-
1:2005 / 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

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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):

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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

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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

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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 containing 20 litres of gas (Cat. No.36-MCG020).
To carry out the calibration locate the calibration switch on the right-
hand side of the instrument as shown below.
Serial
port
Calibration
Switch