CareFusion SmokeCheck Meter Operating Manual Issue 1.0 Jan 2010

Smoke Check Meter Operating manual

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 used for instructional purposes in smoking cessation programs and to check on the clients’ progress and compliance. 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

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I. 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

Cigarette Consumption 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: 4

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

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)

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1

2

3

ON OFF

4

5

6

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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:

Bat Wait Blow Gas

7-10 ppm 20+ ppm 0-6 ppm 11-20 ppm

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: 7

Wait

Important note: the unit must not be used during this period. After twelve seconds the display will change to:

Wait

0-6 ppm 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:

Blow

0-6 ppm

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 8

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:

Gas

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.

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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) complete with a control valve for simple and economic user calibration. The gas is supplied in convenient, disposable, aluminium aerosol cans containing 18 litres of gas (Cat. No.36-MCGK020). Each cylinder is capable of completing 10 calibration procedures. Locate the calibration button positioned inside a hole on the right hand side of the instrument as shown below.

Calibration button

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:

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Plastic Tubing

Control Valve

Flow Indicator Reducing Connector for Calibration

20 ppm carbon monoxide in air

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. 11

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.

•

Do not immerse the unit in the calibration gas.

•

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 8000 tests. When the battery has approximately 1 hour of useful life left the following message will be displayed:

Bat

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

Sensor Expiry Sensor life ranges from 2 to 5 years and depends upon both the amount of exposure to CO and other gases, particularly 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.

Cleaning The mouthpiece adapter may be cleaned using a mild detergent solution or replaced if there is risk of contamination. Exposed surfaces of the meter, other than the sensor surface, may be wiped with a clean, damp cloth. 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.

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

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Symbols Type B device

In accordance with Directive 93/42/EEC 0086

Disposal in compliance with WEEE

Environment This instrument complies with directive EN60601-1-2 electromagnetic compatibility but can be affected by cellular phones and by electromagnetic interference exceeding levels specified in EN 50082-1:1992

Specifications Sensor type

Electro-chemical fuel cell

Range

0 - 20 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 to 5 years

Response time

< 15 sec (to 90% of reading)

Hydrogen cross sensitivity

<15%

Operating temperature

15 – 25 °C

Operating pressure

Atmospheric +/- 10% 14

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

> 8000 tests

Weight

130g without battery

Dimensions

170 x 60 x 26 mm

Display

Custom LCD

Storage temperature

-20 ° to +70 °C

Storage humidity

30% to 90%

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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

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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 used for instructional purposes in smoking cessation programs and to check on the clients’ progress and compliance. 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

II. Introduction – CareFusion 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 Smoke Check is its stability

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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

Cigarette Consumption 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).

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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

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 for calibration (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)

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1

2

ON

3

OFF

4

5

6

20

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:

Bat Wait Blow Gas

7-10 ppm 20+ ppm 0-6 ppm 11-20 ppm

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:

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