CareFusion MicroCO Operating Manual

MicroCO 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 -

中文

1

Contents

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

I. Introduction – English ............................................................ 10

Smoke Inhalation/CO Poisoning....................................................11

Cigarette Consumption and CO Measurements ...............................12

Package Contents .......................................................................13

Contraindications ........................................................................15

Warnings and Cautions................................................................15

Intended Use .............................................................................16

Operation ..................................................................................16

PC Connection ............................................................................19

Calibration .................................................................................19

Battery Life ................................................................................24

Battery Replacement...................................................................24

Internal Battery Expiry ................................................................25

Sensor Expiry ............................................................................25

Cleaning ....................................................................................27

Servicing ...................................................................................28

Trouble Shooting Information .......................................................28

Safety Designation per IEC 60601-1 .............................................29

Electromagnetic Compatibility (EMC) to EN60601-1-2:2007 .............30

Symbols ....................................................................................36

Specifications .............................................................................37

Consumables / Accessories .........................................................38

Customer contact information ......................................................40

Overview ...................................................................................44

II. Introduction – English - USA .................................................. 45

Smoke Inhalation/CO Poisoning....................................................46

Cigarette Consumption and CO Measurements ...............................47

Package Contents .......................................................................48

Contraindications ........................................................................50

2

Warnings and Cautions................................................................50

Intended Use .............................................................................51

Operation ..................................................................................51

PC Connection ............................................................................55

Calibration .................................................................................55

Battery Life ................................................................................59

Battery Replacement...................................................................60

Internal Battery Expiry ................................................................61

Sensor Expiry .......................... Fehler! Textmarke nicht definiert.

Cleaning ....................................................................................62

Servicing ...................................................................................63

Trouble Shooting Information .......................................................63

Safety Designation per IEC 60601-1 .............................................64

Electromagnetic Compatibility (EMC) to EN60601-1-2:2007 .............65

Symbols ....................................................................................71

Specifications .............................................................................72

Consumables / Accessories ..........................................................73

Customer contact information ......................................................75

Présentation ..............................................................................79

III. Introduction – Français .......................................................... 80

Tabagisme/Empoisonnement au CO ..............................................81

Tabagisme et mesures de CO .......................................................82

Contenu de l’emballage ...............................................................83

Contre-indications ......................................................................85

Avertissements et mises en garde ................................................85

Utilisation prévue .......................................................................86

Utilisation ..................................................................................86

Connexion PC .............................................................................89

Calibration .................................................................................89

Durée de vie de la pile ................................................................93

Remplacement de la pile .............................................................94

Durée de vie de la batterie interne ................................................95

3

Durée de vie du capteur ..............................................................95

Nettoyage..................................................................................96

Entretien ...................................................................................97

Diagnostic des pannes.................................................................97

Certificat de sécurité selon la norme CEI 60601-1 ..............................99

Compatibilité électromagnétique (CEM) à la norme EN60601-1-2:2007

....................................................................................... 100

Symboles ................................................................................ 106

Spécifications ........................................................................... 107

Produits de consommation/Accessoires ....................................... 108

Informations de contact clientèle ................................................ 110

Übersicht ................................................................................. 114

IV. Einführung – Deutsch ........................................................... 115

Rauchvergiftung/CO-Vergiftung .................................................. 116

Zigarettenkonsum und CO-Messungen ........................................ 117

Lieferumfang ........................................................................... 118

Kontraindikationen ................................................................... 120

Warn- und Vorsichtshinweise ..................................................... 120

Verwendungszweck .................................................................. 121

Betrieb .................................................................................... 121

PC-Anschluss ........................................................................... 124

Kalibrierung ............................................................................. 124

Batterielebensdauer .................................................................. 128

Batteriewechsel ........................................................................ 129

Haltbarkeit der internen Batterie ................................................ 130

Haltbarkeit des Sensors ............................................................. 130

Reinigung ................................................................................ 131

Wartung .................................................................................. 132

Informationen zur Fehlerbehebung ............................................. 132

Sicherheitsbezeichnung gemäß IEC 60601-1 ................................ 133

Elektromagnetische Verträglichkeit (EMV) gemäß EN60601-1-2:2007

....................................................................................... 134

4

Symbole .................................................................................. 140

Technische Daten ..................................................................... 141

Verbrauchsartikel/Zubehör ........................................................ 142

Kundenkontaktdaten ................................................................. 144

General ................................................................................... 148

V. Introducción – Español ......................................................... 149

Inhalación de humo/Intoxicación por CO ..................................... 150

Consumo de cigarrillos y medición de CO ..................................... 151

Contenido del paquete .............................................................. 152

Contraindicaciones .................................................................... 154

Advertencias y precauciones ...................................................... 154

Uso previsto ............................................................................ 155

Funcionamiento ........................................................................ 155

Conexión al PC ......................................................................... 158

Calibración .............................................................................. 158

Duración de la batería ............................................................... 162

Sustitución de la batería ............................................................ 163

Caducidad de la batería interna .................................................. 164

Caducidad del sensor ................................................................ 164

Limpieza.................................................................................. 165

Mantenimiento ......................................................................... 166

Información de solución de problemas ........................................ 166

Designación de seguridad conforme a IEC 60601-1 ....................... 167

Compatibilidad electromagnética (CEM) de acuerdo con

EN60601-1-2:2007 ............................................................ 168

Símbolos ................................................................................. 174

Especificaciones ....................................................................... 175

Consumibles/Accesorios ............................................................ 176

Información de contacto del cliente ............................................. 178

Visão Geral .............................................................................. 182

VI. Introdução – Português ........................................................ 183

5

Inalação de Fumaça/Envenenamento por CO ............................... 184

Consumo de Cigarros e Medições de CO ...................................... 185

Conteúdo da Embalagem ........................................................... 186

Contraindicações ...................................................................... 188

Avisos e Cuidados ..................................................................... 188

Uso Pretendido ......................................................................... 189

Funcionamento ........................................................................ 189

Conexão ao PC ......................................................................... 192

Calibração ............................................................................... 192

Duração da Bateria ................................................................... 196

Substituição da Bateria ............................................................. 197

Vencimento da Bateria Interna ................................................... 198

Vencimento do Sensor .............................................................. 198

Limpeza .................................................................................. 200

Manutenção ............................................................................. 201

Informações sobre Resolução de Problemas ................................. 201

Designação de Segurança Segundo o IEC 60601-1 ....................... 202

Compatibilidade Eletromagnética (EMC) com a EN60601-1-2:2007 . 203

Símbolos ................................................................................. 209

Especificações .......................................................................... 210

Consumíveis / Acessórios .......................................................... 211

Informações para contato com o cliente ...................................... 213

Overzicht ................................................................................. 217

VII. Inleiding – Nederlands ......................................................... 218

Rookinademing/CO-vergiftiging .................................................. 219

Sigarettenconsumptie en CO-metingen ....................................... 220

Inhoud verpakking .................................................................... 221

Contra-indicaties ...................................................................... 223

Waarschuwingsberichten ........................................................... 223

Bedoeld gebruik ....................................................................... 224

Bediening ................................................................................ 224

Pc-aansluiting .......................................................................... 227

6

Kalibratie ................................................................................. 227

Gebruiksduur batterij ................................................................ 231

Batterij vervangen .................................................................... 232

Interne batterij leeg .................................................................. 233

Sensor vervallen ...................................................................... 233

Reinigen .................................................................................. 234

Service .................................................................................... 235

Informatie over problemen oplossen ........................................... 235

Veiligheidsaanduiding volgens IEC 60601-1 ................................. 237

Elektromagnetische compatibiliteit (EMC) volgens EN60601-1-2:2007

....................................................................................... 238

Symbolen ................................................................................ 244

Specificaties............................................................................. 245

Verbruiksartikelen / accessoires ................................................. 246

Contactinformatie voor klanten .................................................. 248

Panoramica .............................................................................. 252

VIII.Introduzione – Italiano ........................................................ 253

Inalazione di fumo/intossicazione da CO ...................................... 254

Consumo di sigarette e misurazioni di CO .................................... 255

Contenuto della confezione ........................................................ 256

Controindicazioni ...................................................................... 258

Avvertenze e precauzioni ........................................................... 258

Uso previsto ............................................................................ 259

Funzionamento ........................................................................ 259

Collegamento a PC ................................................................... 262

Calibrazione ............................................................................. 263

Durata utile della batteria .......................................................... 267

Sostituzione della batteria ......................................................... 268

Durata utile della batteria interna ............................................... 269

Durata utile del sensore ............................................................ 269

Pulizia ..................................................................................... 270

Assistenza tecnica .................................................................... 271

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Informazioni per la risoluzione dei guasti ..................................... 271

Prescrizioni per la sicurezza secondo la direttiva IEC 60601-1 ........ 272

Compatibilità elettromagnetica (EMC) in conformità con la norma

EN60601-1-2:2007 ............................................................ 273

Simboli.................................................................................... 279

Specifiche ................................................................................ 280

Consumabili / Accessori ............................................................. 281

Informazioni di contatto per i clienti ............................................ 283

Обзор ..................................................................................... 287

IX. Bведение, русский язык ...................................................... 288

Вдыхание дыма/отравление CO ................................................ 289

Курение сигарет и измерения CO ............................................. 290

Комплект поставки .................................................................. 291

Противопоказания ................................................................... 293

Предупреждения и меры предосторожности .............................. 293

Использование ........................................................................ 294

Эксплуатация .......................................................................... 294

Связь с ПК .............................................................................. 297

Калибровка ............................................................................. 297

Время работы от батарей ......................................................... 301

Замена батареи ....................................................................... 302

Истощение внутренней батареи................................................ 303

Окончание срока службы датчика ............................................ 303

Очистка .................................................................................. 304

Сервис .................................................................................... 305

Информация о поиске и устранении неисправностей ................. 305

Описание безопасности по IEC 60601-1 .................................... 307

Электромагнитная совместимость (EMC) по EN60601-1-2:2007 ... 308

Символы ................................................................................. 314

Технические характеристики ................................................... 315

Расходный материал/дополнительные принадлежности ............. 316

Контактная информация для клиентов ...................................... 318

8

综述

....................................................................................... 322

X.

介绍

介绍介绍

介绍

....................................................................................... 323

吸入烟雾/一氧化碳中毒

................................................................. 324

吸烟与一氧化碳测量

..................................................................... 325

包括的配件

................................................................................ 326

警告和小心

................................................................................ 328

设计用途

................................................................................... 329

操作

....................................................................................... 330

与电脑连接

................................................................................ 331

定标

....................................................................................... 332

电池寿命

................................................................................... 337

更换电池

................................................................................... 337

内部电池过期

............................................................................. 338

传感器寿命

................................................................................ 338

清洗

....................................................................................... 338

维修

....................................................................................... 339

故障排除信息

............................................................................. 340

根据

IEC 60601-1

的安全指示

......................................................... 341

符合

EN60601-1:2007

电磁兼容标准

(EMC) ........................................ 342

标志意义

................................................................................... 349

规格参数

................................................................................... 350

消耗品/配件

............................................................................... 351

客户联系信息

............................................................................. 352

9

MicroCO Meter

Operating manual

I. Overview

The MicroCO 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, %COHb, in the 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 Poison level alarm Simple calibration Serial interface to PC

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 MicroCO 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 % carboxyhaemoglobin (%COHb) using the mathematical relationships described by Jarvis et al1, for concentrations below 90 ppm, and by Stewart et al2 for higher levels. Raised levels of carboxyhaemoglobin are most commonly caused by accidental smoke inhalation/CO poisoning or cigarette smoking. The MicroCO includes a countdown timer as an aid to timing the breath holding period prior to exhalation results are displayed on a clear LCD display. Warning lights are provided to give an instant indication of the smoking level.

The countdown timer, warning light levels, and the alarm level are user adjustable when the unit is connected to a PC running COBRA software.

Note: the countdown timer, warning light levels, and the alarm level used throughout this manual are the factory settings and may have been changed.

References

1. Jarvis MJ, Belcher M, Vesey C, Hutchison DCS

Low cost carbon monoxide monitors in smoking assessment

Thorax 1986; 41: 886-887

2. Stewart RD, Stewart RS, Stamm W, Seleen RP

Rapid estimation of carboxyhaemoglobin levels in fire fighters

JAMA 1976; 235, 390-392

11

Smoke Inhalation/CO Poisoning

CO poisoning usually occurs as a result of smoke inhalation from fires or exposure to CO from car exhausts or faulty heating systems. CO binds with haemoglobin to form carboxyhaemoglobin (COHb) which reduces the capacity of the blood to carry oxygen. Acute poisoning may cause symptoms ranging from headache and breathlessness (at COHb levels of 10% to 30%) through confusion to coma and death (COHb usually greater than 60%). A particularly insidious feature of CO poisoning is the development of neurological problems such as movement disorders (often resembling Parkinson’s disease), memory loss and altered personality. Such problems may develop weeks after apparent recovery from acute poisoning.

Chronic exposure to relatively low levels of CO may result in a variety of symptoms including headache, fatigue, poor concentration, dizziness, palpitations, chest pain, visual disturbance, nausea, diarrhoea and abdominal pain.

Chronic CO poisoning as a cause of such symptoms is often missed.

The MicroCO meter allows immediate assessment of patients at risk of CO poisoning who can then be rapidly referred for expert assessment. Prompt treatment with oxygen (in a hyperbaric chamber, if severe) is often life saving. Screening for CO exposure may also reveal the cause of non-specific symptoms relating to low level CO exposure (usually as the result of faulty gas appliances).

Reference

Meredith T, Vale A, Carbon monoxide poisoning British Medical Journal, 1988; 296, 77-78dith

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Cigarette Consumption and CO Measurements

The MicroCO 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 and poisoning victims, together with the alarm light status, are given below:

CO(ppm) %COHb Cigarette consumption Indicator 0 – 6 0 – 1 Non smoker Green 7 –10 1.1 – 1.6 Light smoker Amber 11 – 72 1.8 – 12 Heavy smoker Red >72 >12 Suspected poisoning 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

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

Jones RH, Ellicott MF, Cadigan JB, Gaensler EA Journal of Laboratory and Clinical Medicine 1958; 51, 553 – 564

13

Carbon monoxide in breath in relation to smoking and carboxyhaemoglobin levels

Wald NJ, Idle M, Boreham J, Baily A 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 MicroCO meter is supplied with a carrying case containing the following items:

I. MicroCO meter (Cat No. 36-MC02-STK)

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

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

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

V. 4 Disposable mouthpieces (Box 250 Cat No.36-PSA1200)

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

14

micro

6

5

4

%

C OH b

CO-PPM

OFF

1

3

2

15

Contraindications

There are no known contraindications for using the MicroCO meter.

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

16

IPX0. CAUTION: When you connect the MicroCO 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 MicroCO only to computers that comply with IEC 60601-1 / ANSI/AAMI ES606011:2005 / CAN/CSA-C22.2 No. 60601-1:14.

Intended Use

The MicroCO 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 is used to calculate the percentage of carboxyhaemoglobin, %COHb, in the blood.

The MicroCO is used in smoking cessation clinics, GP’s surgeries, accident and emergency departments, and by the fire-fighting services. In smoking cessation clinics it is used for instructional purposes and to check on the client’s progress and compliance. General practitioners, A&E clinicians and the fire-fighting services can use the instrument to quickly assess the level of suspected CO poisoning.

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

Operation

For accurate results the CO 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

17

adapter into the MicroCO meter and then insert a disposable mouthpiece into the adapter. Turn the unit on by selecting the upper or middle position on the central slide switch and the display will show the software version number.

This will appear momentarily whilst correction for ambient levels is executed. During this time the unit must not be exposed to raised concentrations of CO. The buzzer will then sound and the display will change to:

Upon hearing the buzzer instruct the subject to inspire fully and hold their breath for 20 seconds. The display will count down from 20 to 0 as an aid to timing the breath holding period. The green indicator will then illuminate and the display will change to:

BLOW

At this time the subject should seal their lips around the mouthpiece and exhale slowly and fully. The 20 second breath holding period is recommended to allow time for equilibration of alveolar gas.

If, however, the subject is unable to hold their breath for this period, the unit may still be used before 20 seconds have elapsed.

18

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

The lights will come on according to the table on page 12 and the red light will flash and an alarm will sound if the measurement rises above 72ppm (12%COHb).

If this occurs then the possibility of CO poisoning should be investigated as this level of CO is unlikely to be produced by cigarette smoking.

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:

19

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 MicroCO 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 breath holding countdown timer to be configured to individual requirements.

Note: The MicroCO 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 is recalibrated on a 6 monthly basis. See page 37 for calibration accessories.

20

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 right hand side of the instrument as shown below.

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:

Serial

port

Calibration

Switch

21

20 ppm carbon monoxide in air

Flow Indicator

Control

Valve

Reducing Connector for Calibration

Plastic Tubing

22

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.

23

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

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

24

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.

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

25

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 MicroCO 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 CO meter must be returned to CareFusion, or an authorised agent, for battery replacement.

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.

26

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

Product Lifetime

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

27

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 MicroCO 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 MicroCO 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.

28

Servicing

If your unit requires service or repair please see page 39 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 MicroCO meter, please consult the table below:

Problem Possible Cause Solution

MicroCO 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.

29

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

MicroCO 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

.

30

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

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

emitting equipment near the system may cause unexpected or adverse operation

The MicroCO 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 MicroCO 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 MicroCO.

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

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

It is important that the MicroCO 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 MicroCO may result in increased emissions or decreased immunity of the MicroCO in relation to EMC performance.

The MicroCO 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 MicroCO. 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 MicroCO’s EMC. Use of the cable with devices other than the MicroCO, may result in an increased level of emissions or decreased level of immunity, in relation to the other devices’s EMC.

The MicroCO 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).

31

WARNING:

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

Guidance and Manufacturer’s Declaration

– Electromagnetic Emissions

The MicroCO is intended for use in the electromagnetic environment specified below. The customer or the user of the MicroCO should assure that it is used in such an environment.

Emission Test Compliance Electromagnetic Enviroment -

Guidance

RF emissions CISPR 11

Group 1

The MicroCO uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Group B

The MicroCO is suitable for use in all establishments, including domestic establishments 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 MicroCO is intended for use in the electromagnetic environment specified below. The customer or the user of the MicroCO should assure 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

± 2 kV for power supply lines

Not Applicable (Battery Powered and

Mains power quality should be that of a typical commercial or

32

IEC61000-4-4

± 1 kV for input / output lines

Serial cable <3m)

hospital environment.

Surge IEC61000-4-5

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

Not Applicable (battery Powered)

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

Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11

<5% U

T

(>95 % dip in U

T)

For 0.5 cycle 40% U

T

(60 % dip in U

T)

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 MicroCO requires continued operation during power mains interruptions, it is recommended that the MicroCO 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 MicroCO 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.

33

Guidance and Manufacturer’s Declaration

– Electromagnetic Immunity

The MicroCO is intended for use in the electromagnetic environment specified below. The customer or the user of the MicroCO should assure that it is used in such an environment.

Immunity

Test

IEC 60601

test level

Compliance Level

Electromagnetic Enviroment Guidance

Conducted RF IEC61000-46

Radiated RF IEC61000-4-

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to

2.5 GHz

3 Vrms

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the MicroCO, 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

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:

34

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 MicroCO is used exceeds the applicable RF compliance level above, the MicroCO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the MicroCO.

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

than 3 V/m.

35

Recommended separation distances between portable and mobile RF communications equipment and the MicroCO

The MicroCO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MicroCO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MicroCO 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

36

Symbols

Type B device

0086

In accordance with Directive 93/42/EEC

Disposal in compliance with WEEE

Consult the instructions for use

Date of Manufacture

Manufacturer

Serial number

Single patient use

Rx only

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

37

Specifications

Sensor type Electro-chemical fuel cell Range 0 - 100 ppm Resolution 1 ppm Green indicator light 0 to 6ppm (0 to 1 %COHb) Amber indicator light 7 to 10ppm (1.1 to 1.6 %COHb) Red indicator light 11 to 72ppm (1.8 to12 %COHb) Flashing red light + alarm >72ppm (>12 %COHb) 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 – 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 Main battery life 30 hours of continuous use

equivalent to approximately 2000

tests Internal battery Internal battery life

Lithium ½ AA 3.6 volt

10 years Weight 180 g (Including battery) Dimensions 170 x 60 x 26 mm Display 3 ½ digit LCD Storage & Transport

temperature

-20° to +70 °C

Storage & Transport humidity

30% to 90% RH

38

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 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-CAB1000 Interface cable for COBRA software

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

39

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. The software may be used or copied only in accordance with the terms of that agreement. 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 Lt

40

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

41

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

42

43

44

MicroCO 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 MicroCO 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 carboxyhemoglobin, %COHb, in the blood.

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

Poison level alarm Simple calibration Serial interface to PC

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

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

45

Introduction – English - USA

The MicroCO 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 % carboxyhemoglobin (%COHb) using the mathematical relationships described by Jarvis et al1, for concentrations below 90 ppm, and by Stewart et al2 for higher levels. Raised levels of carboxyhemoglobin are most commonly caused by accidental smoke inhalation/CO poisoning or cigarette smoking. The MicroCO includes a countdown timer as an aid to timing the breath holding period prior to exhalation.

The results are displayed on a clear LCD display. Warning lights are provided to give an instant indication of the smoking level.

The countdown timer, warning light levels, and the alarm level are user adjustable when the unit is connected to a PC running COBRA software.

Note: the countdown timer, warning light levels, and the alarm level used throughout this manual are the factory settings and may have been changed.

References

1. Jarvis MJ, Belcher M, Vesey C, Hutchison DCS

Low cost carbon monoxide monitors in smoking assessment

Thorax 1986; 41: 886-887

2. Stewart RD, Stewart RS, Stamm W, Seleen RP

Rapid estimation of carboxyhemoglobin levels in fire fighters

JAMA 1976; 235, 390-392

46

Smoke Inhalation/CO Poisoning

CO poisoning usually occurs as a result of smoke inhalation from fires or exposure to CO from car exhausts or faulty heating systems. CO binds with hemoglobin to form carboxyhemoglobin (COHb) which reduces the capacity of the blood to carry oxygen. Acute poisoning may cause symptoms ranging from headache and breathlessness (at COHb levels of 10% to 30%) through confusion to coma and death (COHb usually greater than 60%). A particularly insidious feature of CO poisoning is the development of neurological problems such as movement disorders (often resembling Parkinson’s disease), memory loss and altered personality. Such problems may develop weeks after apparent recovery from acute poisoning.

Chronic exposure to relatively low levels of CO may result in a variety of symptoms including headache, fatigue, poor concentration, dizziness, palpitations, chest pain, visual disturbance, nausea, diarrhea and abdominal pain.

Chronic CO poisoning as a cause of such symptoms is often missed.

The MicroCO meter allows immediate assessment of patients at risk of CO poisoning who can then be rapidly referred for expert assessment. Prompt treatment with oxygen (in a hyperbaric chamber, if severe) is often life saving. Screening for CO exposure may also reveal the cause of non-specific symptoms relating to low level CO exposure (usually as the result of faulty gas appliances).

References

Meredith T, Vale A, Carbon monoxide poisoning British Medical Journal, 1988; 296, 77-78dith

47

Cigarette Consumption and CO Measurements

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

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

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

CO(ppm) %COHb Cigarette consumption Indicator 0 – 6 0 – 1 Non smoker Green 7 –10 1.1 – 1.6 Light smoker Amber 11 – 72 1.8 – 12 Heavy smoker Red >72 >12 Suspected poisoning 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

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

Jones RH, Ellicott MF, Cadigan JB, Gaensler EA Journal of Laboratory and Clinical Medicine 1958; 51, 553 – 564

48

Carbon monoxide in breath in relation to smoking and carboxyhemoglobin levels

Wald NJ, Idle M, Boreham J, Baily A 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 MicroCO meter is supplied with a carrying case containing the following items:

I. MicroCO meter (Cat No. 36-MC02-STK)

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

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

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

V. 4 Disposable mouthpieces (Box 250 Cat No.36-PSA1200)

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

49

micro

6

5

4

%

C OH b

CO-PPM

OFF

1

3

2

50

Contraindications

There are no known contraindications for using the MicroCO meter.

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 utilise your local WEEE collection facilities for the disposal of this product.

51

PLEASE NOTE: Degree of protection against Ingress of Water is IPX0. CAUTION: When you connect the MicroCO 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 MicroCO only to computers that comply with IEC 60601-1 / ANSI/AAMI ES606011:2005 / CAN/CSA-C22.2 No. 60601-1:14.

Intended Use

The MicroCO 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 is used to calculate the percentage of carboxyhemoglobin, %COHb, in the blood.

The MicroCO is used in smoking cessation clinics, physician offices emergency departments, and by the fire-fighting services. In smoking cessation clinics it is used for instructional purposes and to check on the client’s progress and compliance. General practitioners, Emergency room personal and the fire-fighting services can use the instrument to quickly assess the level of suspected CO poisoning.

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

Operation

For accurate results the CO 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 MicroCO meter and then insert a disposable

52

mouthpiece into the adapter. Turn the unit on by selecting the upper or middle position on the central slide switch and the display will show the software version number.

This will appear momentarily while correction for ambient levels is executed. During this time the unit must not be exposed to raised concentrations of CO. The buzzer will then sound and the display will change to:

Upon hearing the buzzer instructs the subject to inspire fully and hold their breath for 20 seconds. The display will count down from 20 to 0 as an aid to timing the breath holding period. The green indicator will then illuminate and the display will change to:

BLOW

At this time the subject should seal their lips around the mouthpiece and exhale slowly and fully. The 20 second breath holding period is recommended to allow time for equilibration of alveolar gas.

If, however, the subject is unable to hold their breath for this period, the unit may still be used before 20 seconds have elapsed.

The unit must not be used, however, for one second after the unit is first switched on i.e. before the countdown commences. Expired

53

alveolar gas is then entrapped between sensor and mouthpiece valve. The display reading will rise to a plateau over the course of a several seconds. The final value will be held until the unit is turned off and represents parts per million CO or %COHb depending on the slide switch position.

The lights will come on according to the table on page 46 and the red light will flash and an alarm will sound if the measurement rises above 72ppm (12%COHb).

If this occurs then the possibility of CO poisoning should be investigated as this level of CO is unlikely to be produced by cigarette smoking.

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:

54

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.

55

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 MicroCO 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 breath holding countdown timer to be configured to individual requirements.

Note: The MicroCO 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 is recalibrated on a 6 monthly basis. See page 71 for calibration accessories.

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

56

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

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:

Serial

port

Calibration

Switch

57

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

Slowly turn the control knob counter-clockwise until the ball in the flow indicator is on the first mark.. This will supply the proper amount of flow to the cell.. Apply this flow for 25 seconds and if the meter does not read 20ppm use the calibration tool to push the calibration switch.

20

ppm

carbon monoxide

in air

Flow

Indicator

Control

Valve

Reducing Connector for Calibration

Plastic Tubing

58

CAUTION: opening the control knob more than indicated will give erroneous reading and could damage the cell.

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.

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

59

high, a new calibration value will not be stored and the following will 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 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 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:

60