CareFusion SC01 Operating Manual

Smoke Check Meter

Operating Manual -

English

Operating Manual -

English USA

Manuel d’utilisation -

Français

Betriebshandbuch -

Deutsch

Manual de funcionamiento –

Español

Manual de instruções –

Português

Gebruiksaanwijzing –

Nederlands

Manuale operativo –

Italiano

Руководство пользователя -

Русский

操作手册

操作手册操作手册

操作手册 -

中文

1

Contents

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

I. Introduction - English .....................................................10

Cigarette Consumption and CO Measurements .....................11

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

Contraindications ..............................................................14

Warnings and Cautions ......................................................14

Intended Use ...................................................................15

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

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

Battery Life ......................................................................21

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

Sensor Expiry ...................................................................22

Cleaning ..........................................................................23

Servicing .........................................................................24

Trouble Shooting Information .............................................24

Safety Designation per IEC 60601-1 ...................................25

Electromagnetic Compatibility (EMC) to EN60601-1-2:2007. ..26

Symbols ..........................................................................31

Specifications ...................................................................32

Consumables / Accessories ................................................33

Customer contact information ............................................36

Overview .........................................................................40

II. Introduction – English USA .............................................41

Cigarette Consumption and CO Measurements .....................42

Package Contents .............................................................43

Contraindications ..............................................................45

Warnings and Cautions ......................................................45

Intended Use ...................................................................46

Operation ........................................................................46

Calibration .......................................................................49

Battery Life ......................................................................52

Battery Replacement .........................................................53

Sensor Expiry ...................................................................54

Cleaning ..........................................................................54

Servicing .........................................................................55

Trouble Shooting Information .............................................55

Safety Designation per IEC 60601-1 ...................................57

Electromagnetic Compatibility (EMC) to EN60601-1-2:2007. .58

Symbols ..........................................................................63

2

Specifications ...................................................................64

Consumables / Accessories ................................................65

Customer contact information ............................................68

Présentation .....................................................................73

III. Introduction – Français ..................................................74

Tabagisme et mesures de CO .............................................75

Contenu de l’emballage .....................................................76

Contre-indications .............................................................78

Avertissements et mises en garde .......................................78

Utilisation prévue ..............................................................79

Utilisation ........................................................................79

Commutateur de calibration ...............................................82

Durée de vie de la pile .......................................................85

Remplacement de la pile ....................................................86

Durée de vie du capteur ....................................................86

Nettoyage ........................................................................87

Entretien .........................................................................88

Diagnostic des pannes .......................................................88

Certificat de sécurité selon la norme CEI 60601-1 .................89

Compatibilité électromagnétique (CEM) à la norme

EN60601-1-2:2007 ...........................................................90

Symboles .........................................................................95

Spécifications ...................................................................96

Consommables / Accessoires ..............................................97

Informations de contact clientèle ...................................... 100

Übersicht ....................................................................... 104

IV. Einführung - Deutsch .................................................... 105

Zigarettenkonsum und CO-Messungen .............................. 106

Lieferumfang .................................................................. 107

Kontraindikationen .......................................................... 109

Warn- und Vorsichtshinweise ........................................... 109

Verwendungszweck ......................................................... 110

Betrieb .......................................................................... 110

Kalibrierung ................................................................... 113

Batterielebensdauer ........................................................ 116

Batteriewechsel .............................................................. 117

Haltbarkeit des Sensors ................................................... 118

Reinigung ...................................................................... 118

Wartung ........................................................................ 119

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Informationen zur Fehlerbehebung.................................... 119

Sicherheitsbezeichnung gemäß IEC 60601-1 ...................... 120

Elektromagnetische Verträglichkeit (EMV) gemäß

EN60601-1-2:2007. ........................................................ 121

Symbole ........................................................................ 127

Technische Daten ........................................................... 128

Verbrauchsartikel/Zubehör ............................................... 129

Kundenkontaktdaten ....................................................... 132

General ......................................................................... 136

V. Introducción - Español .................................................. 137

Consumo de cigarrillos y medición de CO ........................... 138

Contenido del paquete ..................................................... 139

Contraindicaciones .......................................................... 141

Advertencias y precauciones ............................................ 141

Uso previsto ................................................................... 142

Funcionamiento .............................................................. 142

Botón .......................................................................... 145

Duración de la batería ..................................................... 148

Sustitución de la batería .................................................. 149

Caducidad del sensor ...................................................... 149

Limpieza ........................................................................ 150

Mantenimiento ............................................................... 151

Información de solución de problemas ............................... 151

Designación de seguridad conforme a IEC 60601-1 ............. 152

Compatibilidad electromagnética (CEM) de acuerdo con

EN60601-1-2:2007 ......................................................... 153

Símbolos ....................................................................... 158

Especificaciones .............................................................. 159

Consumibles/Accesorios ................................................... 161

Información de contacto del cliente ................................... 164

Visão Geral .................................................................... 167

VI. Introdução - Português ................................................ 168

Consumo de Cigarros e Medições de CO ............................ 169

Conteúdo da Embalagem ................................................. 170

Contraindicações ............................................................ 172

Avisos e Cuidados ........................................................... 172

Uso Pretendido ............................................................... 173

Funcionamento ............................................................... 173

Interruptor ..................................................................... 176

4

Duração da Bateria ......................................................... 179

Substituição da Bateria .................................................... 180

Vencimento do Sensor ..................................................... 181

Limpeza ......................................................................... 181

Manutenção ................................................................... 182

Informações sobre Resolução de Problemas ....................... 182

Designação de Segurança Segundo o IEC 60601-1.............. 183

Compatibilidade Eletromagnética (CEM) de acordo com

EN60601-1-2:2007. ........................................................ 184

Símbolos ....................................................................... 189

Especificações ................................................................ 190

Consumíveis/Acessórios ................................................... 192

Informações do cliente para contato .................................. 195

Overzicht ....................................................................... 199

VII. Inleiding - Nederlands .................................................. 200

Sigarettenconsumptie en CO-metingen .............................. 201

Inhoud verpakking .......................................................... 202

Contra-indicaties ............................................................ 204

Waarschuwingsberichten ................................................. 204

Bedoeld gebruik .............................................................. 205

Bediening ...................................................................... 205

Kalibratie ....................................................................... 208

Gebruiksduur batterij ...................................................... 211

Batterij vervangen .......................................................... 212

Sensor vervallen ............................................................. 212

Reinigen ........................................................................ 213

Service .......................................................................... 214

Problemen oplossen ........................................................ 214

Veiligheidsaanduiding volgens IEC 60601-1 ........................ 215

Elektromagnetische compatibiliteit (EMC) volgens

EN60601-1-2:2007. ........................................................ 216

Symbolen ...................................................................... 221

Specificaties ................................................................... 222

Verbruiksartikelen / accessoires ........................................ 223

Contactinformatie voor klanten ......................................... 225

Panoramica .................................................................... 229

VIII. Introduzione - Italiano ................................................. 230

Consumo di sigarette e misurazioni di CO .......................... 231

Contenuto della confezione .............................................. 232

5

Controindicazioni ............................................................ 234

Avvertenze e precauzioni ................................................. 234

Uso previsto ................................................................... 235

Funzionamento ............................................................... 235

Calibrazione ................................................................... 238

Durata utile della batteria ................................................ 241

Sostituzione della batteria ................................................ 242

Durata utile del sensore ................................................... 242

Pulizia 243

Assistenza tecnica ........................................................... 244

Risoluzione guasti ........................................................... 244

Prescrizioni per la sicurezza secondo la direttiva IEC 60601-1

.......................................................................... 245

Compatibilità elettromagnetica (EMC) in conformità con la

norma EN 60601-1-2:2007. ............................................. 246

Simboli .......................................................................... 251

Specifiche ...................................................................... 252

Consumabili / Accessori ................................................... 253

Informazioni di contatto per i clienti .................................. 256

Обзор .......................................................................... 261

XI. Bведение, русский язык .............................................. 262

Курение сигарет и измерения CO .................................... 263

Комплект поставки ........................................................ 264

Противопоказания ......................................................... 266

Предупреждения и меры предосторожности .................... 266

Использование .............................................................. 267

Эксплуатация ................................................................ 267

Калибровка ................................................................... 270

Время работы от батарей ............................................... 273

Замена батареи ............................................................. 274

Окончание срока службы датчика ................................... 274

Очистка ........................................................................ 275

Сервис .......................................................................... 277

Информация о поиске и устранении неисправностей ....... 277

Описание безопасности по IEC 60601-1 .......................... 278

Электромагнитная совместимость (EMC) по

EN60601-1-2:2007 ......................................................... 279

Символы ....................................................................... 285

Технические характеристики .......................................... 286

Расходный материал/дополнительные принадлежности ... 288

Контактная информация для клиентов ............................ 291

6

概述- 简体中文

................................................................. 294

X.

简介

简介简介

简介

-

简体中文

简体中文简体中文

简体中文

................................................................. 295

吸烟与一氧化碳测量

........................................................... 296

包装内容

......................................................................... 297

禁忌症

.......................................................................... 299

警告和小心

...................................................................... 299

设计用途

......................................................................... 300

操作

.......................................................................... 300

定标

.......................................................................... 303

电池寿命

......................................................................... 305

更换电池

......................................................................... 306

传感器寿命

...................................................................... 306

清洗

.......................................................................... 306

维修

.......................................................................... 307

故障诊断信息

................................................................... 307

根据

IEC 60601-1

的安全指示

............................................. 308

符合

EN60601-1-2:2007

的电磁兼容性

(EMC)。 ..................... 309

符号

.......................................................................... 313

规格

.......................................................................... 314

消耗品/配件

..................................................................... 315

客户联系信息

................................................................... 317

7

8

9

Smoke Check Meter

Operating manual

I. Overview

The Smoke Check is a hand held battery operated device used to measure the concentration of carbon monoxide, CO, on the breath.

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 High CO alarm Simple calibration

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

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

10

Introduction - English

The Smoke Check 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 and displays peak expired concentrations of alveolar gas. High levels of expired CO indicate raised levels of carboxyhaemoglobin, most commonly caused by cigarette smoking.

The results are displayed in four ranges on a clear LCD display. Warning lights are provided to give an instant indication of the smoking level. A particular feature of the CareFusion Smoke Check is its stability of calibration and low cross sensitivity to other exhaled gases such as hydrogen.

References

Jarvis MJ, Belcher M, Vesey C, Hutchison DCS

Low cost carbon monoxide monitors in smoking assessment

Thorax 1986; 41: 886-887

11

Cigarette Consumption and CO Measurements

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

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

Typical values for 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 20+ Very heavy smoker Flashing red + 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).

References

Jones RH, Ellicott MF, Cadigan JB, Gaensler EA

The relationship between alveolar and blood carbon monoxide concentrations during breath holding

Journal of Laboratory and Clinical Medicine 1958; 51, 553 - 564 Wald NJ, Idle M, Boreham J, Baily A

Carbon monoxide in breath in relation to smoking and carboxyhaemoglobin levels

Thorax 1981; 36, 366-369

12

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).

Correlation between exhaled CO measurements and carboxyhaemaglobin percentage in smokers

Marino Luigi; Latini Roberto; Barbano Gina; Bazzerla; Zanette Antonia; Nardini Stefano - Respiratory and TB Unit- General Hospital- Via Forlanini, 71- I-31029-Vittorio Veneto (TV- ITALY).

Package Contents

The Smoke Check is supplied with a carrying case containing the following items:

1. Smoke Check meter (Cat No. 36-SC01-STK)

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

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

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

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

6. Calibration button tool (Cat No. 36-MEC1299)

13

6

5

4

ON

OFF

1

3

2

14

Contraindications

There are no known contraindications for using the Smoke Check monitor

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.

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.

15

Intended Use

The Smoke Check is intended to measure the concentration of carbon monoxide, (CO) on the breath. It is used in smoking cessation clinics as a motivational aid, GP’s surgeries, accident and emergency departments, and by the fire-fighting services.

The Smoke Check is designed for use by clinicians and health care professionals.

Operation

For accurate results the Smoke Check 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 Smoke Check meter and then insert a disposable cardboard mouthpiece into the adapter. If possible, the subject should rinse their mouth with clean water prior to performing a test. Do not use mouthwash, as the readings will be affected.

To obtain an accurate reading from a sample of alveolar gas the patient should inspire and hold their breath for 20 seconds before expiring slowly and fully through the mouthpiece. As an aid to timing the breath holding period, a buzzer will sound 20 seconds after the unit is turned on. However the instrument may be used any time after the first 12 seconds when the auto-zero has been performed.

Turn the unit on by pushing the central slide switch up and the three coloured lights will illuminate momentarily together with all the display legends:

16

Ask the subject to inspire and hold their breath.

The unit will auto-zero for twelve seconds during which time the following will be displayed:

Important note: the unit must not be used during this period.

After twelve seconds the display will change to:

The subject may now seal their lips around the mouthpiece and exhale slowly and fully if they cannot hold their breath any longer. However, more accurate results will be obtained if they hold their breath until the buzzer sounds and the display changes to:

0-6

Wait

7-10 ppm 0-6 ppm

Bat

Wait

Blow

Gas

20+ ppm 11-20 ppm

Wait

17

The CO 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 will be displayed in one of the four ranges:

0–6 ppm with green indicator 7–10 ppm with amber indicator 11–20 ppm with red indicator 20+ ppm with flashing red indicator and alarm

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 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:

Blow

0-6 ppm

Gas

18

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.

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 is recalibrated on a 6 monthly basis. See page 33 for calibration accessories.

19

The gas is supplied in convenient, disposable, aluminium aerosol cans (Cat. No.36-MCG020).

Locate the calibration button positioned inside a hole on the right hand side of the instrument as shown below.

Turn the unit on and wait for the unit to display ‘Blow’.

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

Calibration

button

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 then use the calibration button tool to depress the calibration button.

20 ppm carbon monoxide in air

Flow

Indicator

Control Valve

Reducing Connector for Calibration

Plastic Tubing

21

The sounder will beep and the display will flash three times as the calibration is recorded. The ‘GAS’ legend will then be displayed. Turn off the gas supply and the unit. When the cell has expired it will be impossible to obtain a correct calibration and all the legends and the three lights will flash five times with no beeps after the calibration button is depressed. The ‘GAS’ legend will be displayed as before and the unit must be turned off before recalibration is attempted.

Important Notes:

• Only certified calibration gas (20ppm) 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.

• 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 sufficient for approximately 2000 tests.

When the battery has approximately 1 hour of useful life left the following message will be displayed:

and the alarm will sound momentarily after the unit is first switched on. When the battery has completely expired the above will be displayed continuously and the battery must be replaced.

Bat

22

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.

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.

Sensor Expiry

Sensor life is 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 Smoke Check must be returned to CareFusion or an authorised agent, for sensor replacement.

23

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: Always switch off the device 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 Smoke Check 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.

24

If there are changes on the material surfaces of either the unit or mouthpiece adaptor (cracks, brittleness) the respective parts must be disposed off.

Servicing

A full service manual including circuit diagram and parts list is available upon request.

If your unit requires service or repair please see page 36 for contact details

Trouble Shooting Information

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

Problem Possible Cause Solution

Smoke Check 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

“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.

Unit will not calibrate Gas cylinder empty Check valve on

cylinder for contents and replace cylinder if necessary

25

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 nonelectrical connection to the patient.

Degree of mobility Transportable Mode of operation Continuous

Classifications according to IEC 60601-1

Smoke Check 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.

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

Product Lifetime

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

26

Electromagnetic Compatibility (EMC) to EN60601-12:2007.

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

emitting equipment near the system may cause unexpected or adverse operation.

The Smoke Check monitor has been tested to EN 60601-1-2-2007, regarding its ability to operate in an enviroment containing other equipment electrical/electronic equipment (including other medical devices)

The purpose of this testing is to ensure that the Smoke Check monitor is not likely to adversely affect the normal operation of other such equipment and that other such equipment is not like to adversely affect the normal operationof the Smoke Check monitor.

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

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

It is important that the Smoke Check monitor is configured and installed/put inot service in accordance with the instructions/guidnce provided herein and is used only in the configuration as supplied.

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

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

27

For the purposes of EN 60601-1-2 the Smoke Check monitor has an essential performance (the Smoke Check should continue to indicate a level of 11-20 p.p.m. during a test, whilst measuring gas from a 15p.p.m. CO gas bottle)

Guidance and Manufacturer’s Declaration – Electromagnetic Emission

The Smoke Check is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or the user of the Smoke Check should ensure that it is used in such an environment

Emission Test Compliance Electromagnetic Enviroment -

Guidance

RF emissions CISPR 11

Group 1

The Smoke Check uses RF energy only for its internal function. Therefore, its RF emission is very low and is not likely to cause any interference in nearby

electronic equipment. RF emissions CISPR 11

Group B

The Smoke Check is suitable for use in

all establishments, including domestic

and those directly connected to the

public low-voltage power supply network

that supplies buildings used for domestic

purposes

Harmonic emissions IEC61000-3-2

Not Applicable (battery powered)

Voltage fluctuatuins / flicker emissions

IEC61000-3-3

Not Applicable (battery powered)

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The Smoke Check is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or the user of the Smoke Check should ensure that it is used in such an environment

Immunity Test IEC 60601 test

level

Compliance Level

Electromagnetic Enviroment -Guidance

Electrostatic discharge (ESD)

IEC61000-4-2

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient / burst

IEC61000-4-4

± 2 kV for power supply lines

± 1 kV for input / output lines

Not Applicable (Battery

powered)and no cables

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC61000-4-5

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

Not Applicable (Battery

Powered) and no cables.

Mains power quality should be that of a typical commercial or hospital environment.

28

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC61000-4-11

<5% U

T

(>95 % dip in UT) For 0.5 cycle 40% U

T

(60 % dip in UT) for 5 cycles 70 % U

T

(30 % dip in UT) for 25 cycles <5% U

T

(>95 % dip in UT) For 5 s

Not Applicable (Battery

Powered)

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Smoke Check requires continued operation during power mains interruptions, it is recommended that the Smoke Check be powered from an uninterruptable power supply or a battery.

Power frequency (50/60Hz)

Magnetic field IEC61000-4-8

3 A/m 3 A/m If incorrect operation occurs,

it may be necessary to position the Smoke Check further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low.

NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The Smoke Check is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or the user of the Smoke Check should ensure that it is used in such an environment

Immunity

Test

IEC 60601

test level

Compliance Level

Electromagnetic Enviroment Guidance

Conducted RF IEC61000-4-6

3 Vrms 150 kHz to

80 MHz

N/A

(Battery

Powered)and

No Cables

Portable and mobile RF communications equipment should be used no closer to any part of the Smoke Check, including any cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance (d)

d = 1.2√P

29

Radiated RF IEC61000-4-3

3 V/m 80 MHz to

2.5 GHz

3 V/m d = 1.2√P 80 MHz to 800 MHz

d = 2.3√P 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Fields strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

a

should be less than the compliance level in each frequency range.

b

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

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation

is affected by absorption and reflection from structures, objects and people.

a.

Field strengths from fixed transmitters, such as base stations for radio

(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Smoke Check is used exceeds the applicable RF compliance level above, the Smoke Check should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the Smoke Check.

b.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than

3 V/m.

30

Recommended separation distances between portable and mobile RF communications equipment and the Smoke Check

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

communications equipment.

Rated Maximum Output Power of Transmitter in Watts (W)

Separation Distance in Meters (m) according to Frequency of Transmitter

150 KHz to 80 MHz

d = 1.2√P

80 MHz to 800 MHz

d = 1.2√P

800 MHz to 2.5 GHz

d = 2.3√P

0.01

0.12 0.12

0.23

0.1

0.38 0.38

0.73

1

1.2 1.2

2.3

10

3.8 3.8

7.3

100

12 12

23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures objects and people

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Symbols

Type B device

0086

In accordance with Directive 93/42/EEC

Disposal in compliance with WEEE

Consult the instructions for use

Manufacturer

Date of Manufacture

Serial number

Single patient use

Rx only

Federal U.S. law restricts this device to sale by or on the order of a physician.

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Specifications

Sensor type Electro-chemical fuel cell Range Resulution

0-100 ppm

1 ppm Detected levels: Display: 0 to 6ppm 0-6 ppm with green indicator 7 to 10ppm 7-10 ppm with amber indicator 11 to 20ppm 11-20 ppm with red indicator >20 ppm 20+ ppm with red indicator +

alarm Accuracy +/-5% of reading or 1ppm

whichever is the greater Sensitivity drift 0.5%/°C Sensor life > 2 years Response time < 15 sec (to 90% of reading) Hydrogen cross sensitivity <15% Operating temperature 15 °C - 25 °C Operating pressure Atmospheric +/- 10% Pressure coefficient 0.02% signal per mBar Relative humidity 15 - 90% continuous (Non condensing) (0 - 99% intermittent) Baseline drift 0ppm (auto-zero) Long term drift < 2% signal loss per month Power source Single Alkaline 9 volt PP3 Battery life > 2000 tests Weight 130g without battery Dimensions 170 x 60 x 26 mm Display Custom LCD Storage & Transport temperature -20 °C to +70 °C Storage & Transport humidity 30% to 90% RH

33

Consumables / Accessories

Cat. No. Description

36-PSA1200

22mm paediatric disposable mouthpieces (250 per box)

36-PSA2000

22mm mouthpiece adaptor with one-way valve (pack of 10)

36-PSA1100

Adapter for paediatric disposable mouthpieces

36-BAT1002 Alkaline PP3 Battery 36-MEC1184 Calibration Tool

36-MCG020

Medican calibration gas canister 20ppm Carbon Monoxide in air

36-MGA222

MicroFlow pressure reducer for Medican calibration gas canister with flow indicator

36-MEC1007 22mm reducing connector for calibration

36-SSC5000A

Perasafe sterilising powder (to make up 5 litres of solution)

36-VOL2104 Nose Clips (pack of 5)

For further information or to place an order for Disposables/ Supporting products please contact CAREFUSION, your local distributor or view our website www.carefusion.com/micromedical

PLEASE NOTE: USE ONLY CAREFUSION ACCESSORIES

34

Please Note: Information in this manual is subject to change without notice and does not represent commitment on the part of CareFusion 232 UK Ltd. No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording for any purpose without the written permission of CareFusion 232 UK Ltd.

35

36

Customer contact information

UK Customers only

For all Sales Order processing for products, training and spare parts, Service and Technical Support enquiries, please contact the following:

CareFusion UK 232 Ltd UK Customer Service & Support The Crescent Jays Close Basingstoke RG22 4BS

Customer Service Sales Enquiries: Telephone: 01256 388550 Email: micro.uksales@carefusion.com

Factory Repair and Administration Enquiries: Telephone: 01256 388552 Email: micro.ukservice@carefusion.com

Technical Support Enquiries: Telephone: 01256 388551 Email: support.rt.eu@carefusion.com

37

International customers only

For all Sales Order processing for products and Spare parts, Service and Technical Support enquiries, please contact the following:

CareFusion Germany 234 GmbH Customer Service & Support International Leibnizstraße 7 97204 Hoechberg Germany

Customer Service Sales Enquiries: Telephone: 0049 931 4972 670 Email: micro.internationalsales@carefusion.com

Factory Repair and Administration Enquiries: Telephone: 0049 931 4972 867 Email: support.admin.eu@carefusion.com

Technical Support Enquiries: Telephone: 0049 931 4972 127 Email: support.rt.eu@carefusion.com

38

39

40

Smoke Check Meter

Operating manual

Federal (USA) law restricts this device to sale by or on the order of a

physician or licensed practitioner.

CareFusion,

22745 Savi Ranch Parkway,

Yorba Linda

CA 92887-4668

USA

II. Overview

The Smoke Check is a hand held battery operated device used to measure the concentration of carbon monoxide, CO, on the breath.

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

These include: Auto zero function Smoking level color light indicators High CO alarm Simple calibration

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

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

41

Introduction – English USA

The Smoke Check 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 and displays peak expired concentrations of alveolar gas. High levels of expired CO indicate raised levels of carboxyhaemoglobin, most commonly caused by cigarette smoking.

The results are displayed in four ranges on a clear LCD display. Warning lights are provided to give an instant indication of the smoking level. A particular feature of the CareFusion Smoke Check is its stability of calibration and low cross sensitivity to other exhaled gases such as hydrogen.

References

Jarvis MJ, Belcher M, Vesey C, Hutchison DCS

Low cost carbon monoxide monitors in smoking assessment

Thorax 1986; 41: 886-887

42

Cigarette Consumption and CO Measurements

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

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

Typical values for 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 20+ Very heavy smoker Flashing red + 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).

References

Jones RH, Ellicott MF, Cadigan JB, Gaensler EA

The relationship between alveolar and blood carbon monoxide concentrations during breath holding

Journal of Laboratory and Clinical Medicine 1958; 51, 553 - 564 Wald NJ, Idle M, Boreham J, Baily A

Carbon monoxide in breath in relation to smoking and carboxyhaemoglobin levels

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Thorax 1981; 36, 366-369

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).

Correlation between exhaled CO measurements and carboxyhaemaglobin percentage in smokers

Marino Luigi; Latini Roberto; Barbano Gina; Bazzerla; Zanette Antonia; Nardini Stefano - Respiratory and TB Unit- General Hospital- Via Forlanini, 71- I-31029-Vittorio Veneto (TV- ITALY).

Package Contents

The Smoke Check is supplied with a carrying case containing the following items:

1. Smoke Check meter (Cat No. 36-SC01-STK)

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

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

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

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

6. Calibration button tool (Cat No. 36-MEC1299)

44

6

5

4

ON

OFF

1

3

2

45

Contraindications

There are no known contraindications for using the Smoke Check monitor

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 anesthetic 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.

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

PLEASE NOTE: Degree of protection against Ingress of Water is IPX0.

46

Intended Use

The Smoke Check is intended to measure the concentration of carbon monoxide, (CO) on the breath. It is used in smoking cessation clinics as a motivational aid, GP’s surgeries, accident and emergency departments, and by the fire-fighting services.

The Smoke Check is designed for use by clinicians and health care professionals.

Operation

For accurate results the Smoke Check 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 Smoke Check meter and then insert a disposable cardboard mouthpiece into the adapter. If possible, the subject should rinse their mouth with clean water prior to performing a test. Do not use mouthwash, as the readings will be affected.

To obtain an accurate reading from a sample of alveolar gas the patient should inspire and hold their breath for 20 seconds before expiring slowly and fully through the mouthpiece. As an aid to timing the breath holding period, a buzzer will sound 20 seconds after the unit is turned on. However the instrument may be used any time after the first 12 seconds when the auto-zero has been performed.

47

Turn the unit on by pushing the central slide switch up and the three colored lights will illuminate momentarily together with all the display legends:

Ask the subject to inspire and hold their breath.

The unit will auto-zero for twelve seconds during which time the following will be displayed:

Important note: the unit must not be used during this period.

After twelve seconds the display will change to:

0-6 ppm

Wait

7-10 ppm 0-

6 ppm

Bat

Wait

Blow

Gas

20+ ppm 11-20 ppm

48

The subject may now seal their lips around the mouthpiece and exhale slowly and fully if they cannot hold their breath any longer. However, more accurate results will be obtained if they hold their breath until the buzzer sounds and the display changes to:

The CO 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 will be displayed in one of the four ranges:

0 - 6 ppm with green indicator 7 - 10 ppm with amber indicator 11 - 20 ppm with red indicator 20+ ppm with flashing red indicator and alarm

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 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.

Blow

0-6 ppm

49

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.

Calibration

Calibration will remain stable to within 2% over one month and typically to within 10% over 6 months. CareFusion supplies calibration gas (20 ppm CO in air) and recommends that the unit is recalibrated on a 6 monthly basis. See page 65 for calibration accessories.

Gas

50

The gas is supplied in convenient, disposable, aluminum aerosol cans (Cat. No.36-MCG020).

Locate the calibration button positioned inside a hole on the right hand side of the instrument as shown below.

Turn the unit on and wait for the unit to display “Blow”.

Calibration

button

51

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

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

20 ppm

carbon

monoxide in air

Flow

Indicator

Control Valve

Reducing Connector for Calibration

Plastic Tubing

52

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 then use the calibration button tool to depress the calibration button.

The sounder will beep and the display will flash three times as the calibration is recorded. The “GAS” legend will then be displayed. Turn off the gas supply and the unit. When the cell has expired it will be impossible to obtain a correct calibration and all the legends and the three lights will flash five times with no beeps after the calibration button is depressed. The “GAS” legend will be displayed as before and the unit must be turned off before recalibration is attempted.

Important Notes:

• Only certified calibration gas (20 ppm) 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 stabilized

at room temperature before calibrating.

• 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 sufficient for approximately 2000 tests.

When the battery has approximately 1 hour of useful life left the following message will be displayed:

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