MD DIAGNOSTICS CO Check Plus Baby Instruction Manual

CO Check + / CO Check + Baby

Operating Manual

MD Diagnostics Ltd
Slip 7 Annexe
The Historic Dockyard
Chatham
Kent ME4 4TZ
UK

Tel: + 44 (0) 1634 949010

Email: sales@mdd.org.uk
http://www.mdd.org.uk

Advena Ltd.
Tower Business Centre
2nd Flr., Tower Street,
Swatar, BKR 4013, Malta.

Revision 14.1 May 2022
Part No. MAN01 Drawing No. 1015-01

Package Contents

The CO Check + / CO Check+ Baby are supplied with:

1. CO Check + (Cat. No. CO10) / CO Check + Baby (Cat no. CO15)
2. 22 mm reducing connector for calibration (CSC01)
3. 9V PP3 Battery
4. SafeBreath™ filtered cardboard mouthpieces (Cat no. FM200 Box of 200)
5. Soft shell carry pouch
6. Operating Manual
7. CO / Pregnancy CO – Guide charts

Keypad Interface = ON/OFF Power button
= Select Function button

Overview

All patients attending a smoking cessation programme should have their smoking habits established and checked with the CO Check+ at every visit. The results of an initial test may sound alarming to many smokers but within a few days of stopping, CO levels can drop to normal, and it is very encouraging for a smoker to see this. CO monitoring is an extremely powerful tool for a smoking cessation counsellor, GP, midwife or respiratory physician.

Taking a test before a patient stops smoking will help you gauge their level of nicotine dependence and taking it after they have stopped will give them real proof that what they are doing is working.

The best time to do a test is in the afternoon as CO levels fall over-night and morning readings can sometimes give misleadingly low results. High readings in the morning on the other hand, would be strong evidence of heavy inhalation and high nicotine dependence or CO poisoning from another cause..

When the Environmental reading is enabled, background CO levels are taken into account when carrying out a breath test. If the background levels are 10ppm for example, then when the person is taking a breath test this background reading of 10ppm will be taken into account.

For example, if the Environmental monitor is ON and a reading of 10ppm is detected and the patient records 3ppm, then the measurement displayed will be the higher value i.e. 10ppm.

Conversely, if the Environmental monitor is OFF, then the measurement displayed, will be the actual value recorded by the patient i.e. 3ppm.

Intended Use

The CO Check + / CO Check + Baby are handheld portable battery-operated devices used for measuring the carbon monoxide (CO) concentration on the breath, calculating the percentage of carboxyhaemoglobin (%COHb) in the blood and for the CO Check + Baby, also the percentage of foetal carboxyhaemoglobin (%FCOHb).

They are specifically designed as a screening tool for smoking cessation but can also be used in A&E departments, GP surgeries, midwives and by the firefighting service. In smoking cessation clinics, they can be used for checking the subject’s progress and compliance. A&E clinicians, fire fighters and GPs can use the device to quickly assess the level of suspected CO poisoning.

They are easy to use, very accurate and require a single breath into the device to display CO results in parts per million (PPM) and the percentage of carboxyhaemoglobin, %COHb and the percentage of foetal carboxyhaemoglobin (%FCOHb) – (CO Check+ Baby only).

They also measure ambient CO on switch ON to ensure that the environment is free from CO contamination (if enabled).

Accessories

There are various accessories available for use with the CO Check+/CO Check + Baby device. MD Diagnostics recommend the use of SafeBreath™ filtered mouthpieces. SafeBreath disposable cardboard filtered mouthpieces have a proven bacterial/viral efficacy >99%

Note: SafeBreath™ mouthpieces are single patient use and should be disposed of after each patient – using the same mouthpiece for different patients, will increase the risk of cross contamination between patients.

Operation

Insert the 9V PP3 battery by removing the battery cover and clipping the battery in place, replace the battery cover. Insert the SafeBreath cardboard filtered mouthpiece.

Turn the CO Check ON by pressing Power key . The device will display the version number before starting the countdown timer.

The unit will countdown for 10 seconds to ensure that the sensor is stabilised.

When the countdown timer reaches zero it will display the current environment reading if enabled.

If the Environmental monitor is disabled, it will zero to ambient air automatically.

Press the Select Function key and the unit will start ‘breath hold’ countdown timer of 15 seconds (CO Check+) and 10 seconds (CO Check + Baby). Encourage the subject to hold the breath until the unit beeps to start the test. The display will show the blow icon.

The subject should place their lips around the SafeBreath™ cardboard mouthpiece and blow gently and continue blowing until their lungs are completely empty. CO is collected in the last portion of the breath (alveolar breath).

Results Display

The CO Check will beep and show the final reading in PPM (parts per million).

By pressing the Select Function key the reading changes to %COHb (carboxyhaemoglobin)

and then press Select Function key to display % FCOHb (foetal carboxyhaemoglobin) – (CO Check Baby only)

Pressing again reverts back to PPM.

The maximum reading the CO Check can measure is 99 PPM. Any reading above that will be displayed as – – (over range).

After examining the readings, the unit can either be switched off using the ON/OFF Power key or another measurement can be carried out by pressing the Select Function key for at least three seconds.

To save the battery, the unit will switch OFF automatically after three minutes if not used.

Warning/Cautions

If higher than expected levels of CO are displayed this could be due to CO poisoning and medical attention should be immediately sought.
The CO Check has a cross-sensitivity to hydrogen (from some gastro-intestinal disorders) which may affect the reading.
Cleaning with products that contain alcohol may result in permanent damage to the sensor. See Spares for non-alcohol wipes.
The battery should be changed when the word ‘BAT’ appears on the display.
SafeBreath™ mouthpieces, are single patient use and should be disposed of after each patient – using the same mouthpiece for different patients will increase the risk of cross contamination between patients.
Please only use accessories supplied by MD Diagnostics to ensure the device performs as intended.

Calibration

The device should be recalibrated at least once every six months.
Calibration gas can be purchased from MD Diagnostics Ltd, see Spares for full ordering details.

1. Control Valve
2. Flow Indicator
3. Plastic Tubing
4. Reducing Connector for Calibration
5. 20 ppm carbon monoxide in air

To calibrate the device, perform the following steps:

1. Connect the control valve (Cat. No. CV12) to the 20 ppm gas cylinder (Cat. No. C1220) calibration gas cylinder shown in the diagram on page 8.
2. Connect the short plastic tubing reducing connector (Cat. No. CSC01).
3. Switch ON the device with the select function key held down until the device displays ‘Cb.’ Release the function key.

4. The device will countdown from 15 to 0 with CAL symbol ON. It will then display the blow icon.

5. Attach the connector and open the control valve (anti-clockwise) until ball in the flow indicator is between the two marks. This will supply the gas of approximately 0.5 L/min.
6. Apply this flow until the device beeps, after 20 seconds. The device will display the reading.
7. Press the select function key for at least 3 seconds to accept the new calibration value. The device will show ‘dn’ and show 20ppm.

It is advisable to accept the calibration even though it displays 20 ppm. This will reset the calibration due timer.
Switch off the device if the calibration was incorrectly performed. Do not press the Select Function key

To prevent incorrect calibration, only the readings within the range of 16-24 can be calibrated. An ‘Er’ (Error) message will be displayed if the calibration is accepted for reading outside this range.

8. Switch off the device; wait for a minute and it is now ready for use.

If the device is not calibrated for six months, the device will beep three times before countdown starts and will display ‘Cd’ (Calibration due) for 3 seconds. Thereafter the device will operate as normal, but the reading will not be guaranteed.

Setting Environment Mode

Environment reading on start-up can be disabled or enabled. Switch ON the unit and wait for the countdown to begin. When the number

approaches 5, press the select function key . When the unit beeps at 4, release the select function key . At the end of the countdown, the unit will display ‘En’ for 3 seconds followed by either ‘OF’ (Off) or ‘On’ – your current setting.

Press the select function key momentarily (< 0.5 sec), to change the mode. Press the select function key for more than 3 seconds to accept the mode either ‘On’ or ‘OF’ (Off). Thereafter the unit will restart with your selected setting.

Battery Life

The 9V PP3 battery should give at least 30 hours of continuous use. When the battery is low, it will display ‘bL’ (battery low) for three seconds.

The device can still be used, but it is advisable to replace the battery.

It is recommended to use an Alkaline battery.

If the battery is very low such that the reading is not reliable, it will display ‘bd’ (battery dead) and will not operate any more.

Power Saving

To save battery power, the device will automatically turn itself off after three minutes of the last key press.

To prevent the device from switching off, press the select function key within three minutes of last press or when the reading is first displayed.

Cleaning

The device can be cleaned using non-alcohol wipes (see Spares). Please be certain not to touch the surface of the sensor or allow moisture to do the same. Please do not saturate the device liquid may ingress the device and cause damage.

Cleaning with products that contain alcohol may result in permanent contamination of the sensor.

Servicing

If your unit requires servicing or repair, then please contact your authorised distributor or MD Diagnostics Ltd directly.

The CO Sensor should be replaced every five years.

If the device starts with ‘Er’ (Error) message, it should be returned for service.

Email:    customercare@mdd.org.uk
Tel:        + 44 (0) 1634 949010

Spares

(Box of 200 Cat No. FM200)
TDW01| Bacterial cleansing wipes
BAT02| 9V PP3 alkaline battery
CASE1 | Soft shell carry pouch

Specifications

Symbols

In accordance with Directive 93/42/EEC
1639

EU Representative

Type B Device

To avoid the potential effects on the environment and human health because of the presence of hazardous substances in electrical and electronic equipment, end users of electrical and electronic equipment should understand the meaning of the crossed-out wheeled bin symbol. Do not dispose of WEEE as unsorted municipal waste and have to collect such WEEE separately.

Important information regarding Electromagnetic Compatibility (EMC)

Medical devices may be susceptible to electromagnetic interference from other devices such as PC’s and mobile telephones. Electromagnetic interference may impair the operation of the medical device and could create a potentially unsafe situation.
To regulate the requirements for EMC, to limit unsafe product situations, BS EN 60601-1-2 standard has been implemented. This standard defines the levels of Immunity to electromagnetic interference as well as the levels of electromagnetic Emissions for medical devices.
As a medical device the CO Check conforms to BS EN60601-1-2 standard for both Immunity and Emissions.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The CO Check is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
Immunity Test| IEC 60601 Test level| Compliance level| Electromagnetic environment guidance
Radiated Immunity
IEC 61000-4-3| 10V/m| 10V/m| Avoid use in environments likely to exceed 10V/m
Electrostatic Discharge (ESD)
IEC 61000-4-2| ± 6 kV contact
± 8 kV air| ± 6 kV contact
± 8 kV air| No restrictions in the intended environment
Electrical fast transient/ burst
IEC 61000-4-4| N/A| N/A| None
Surge
IEC 61000-4-5| N/A| N/A| None
Voltage dips, short interruptions, and voltage variations on power supply input lines
IEC 61000-4-11| N/A| N/A| None
Power Frequency (50/60 Hz) magnetic field
IEC 61000-4-8| N/A| N/A| None

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

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The CO Check is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
Emissions Test| Compliance level| Electromagnetic environment guidance
RF Emissions CISPR 11| Group 1| The CO Check uses RF energy only for its 18 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| Class B| The CO Check can be used in domestic, light, and heavy industrial environments.
Harmonic emissions IEC 61000-3-2| [Not Applicable]|
Voltage fluctuations / flicker emissions IEC 61000-3-3| [Not Applicable]|
| [See 5.2.2.1 c) and Figure 1]| The CO Check is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplied buildings used for domestic purposes.
| [See 5.2.2.1 c) and Figure 1]| The CO Check is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplied buildings used for domestic purposes.
RF Emissions CISPR 14-1| Complies| The CO Check is not suitable for interconnection with other equipment.
RF Emissions CISPR 15| Complies| The CO Check is not suitable for interconnection with other equipment.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The CO Check is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
Immunity Test| IEC 60601 Test level| Compliance level| Electromagnetic environment guidance
Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

| 3 Vrms 150 KHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

| [V1] V

[E1] V/m

| Portable and mobile RF
communications equipment should be used no closer to any part of the CO Check, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distanced = [3.5]√P

V1

d = [3.5]√P     80 MHz to 800 MHz

E1

d = [7]√P        800 MHz to 2.5 GHz
…….E1

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).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a, should be less than the compliance level is each frequency range. b

Interference may occur in the vicinity of equipment marketed 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 strength 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 RD transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CO Check is used exceeds the applicable RD compliance level above, the CO Check should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the CO Check.

b Over the frequency range 150 KHz to 80 MHz, field strength should be less that [V1] V/m

References

• CO Breath Test Monitors: Check Your Carbon Monoxide Levels
• CO Breath Test Monitors: Check Your Carbon Monoxide Levels

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