Micro Direct CO Check+ User manual

CO Check + / CO Check + Baby
Operating Manual
Micro Direct, Inc.
803 Webster Street
Lewiston, ME 04240
1-800-588-3381
www.mdspiro.com
Revision 11.0 May 2018
Part No. MAN01 Drawing No. 1015-01

1
CONTENTS
Package Contents...................................................................... 2
Overview .................................................................................... 3
Intended Use.............................................................................. 3
Accessories................................................................................ 4
Operation ................................................................................... 4
Operation (Environmental Mode Enabled)................................. 6
Warning/Cautions....................................................................... 8
Calibration.................................................................................. 9
Setting Environment Mode.......................................................11
Battery Life...............................................................................12
Power Saving...........................................................................12
Cleaning................................................................................... 13
Servicing .................................................................................. 13
Consumables ........................................................................... 14
Specifications...........................................................................14
Symbols ................................................................................... 15
Important information regarding Electromagnetic Compatibility
(EMC).......................................................................................15

2
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
3. 9 Volt Battery
4. SafeBreath™filtered cardboard mouthpieces (Box of 200
Cat No. FM200) or cardboard mouthpieces (Bag of 100
Cat No. 3301)
5. Soft shell carry pouch
6. Operating Manual
Keypad Interface = ON/OFF Power button
= Select Function button
* See cleaning guidance on page 13.

3
Overview
All patients attending a smoking cessation program should have
their smoking habits established and checked with the CO
Check+/CO Check+ Baby 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 counselor,
physician or respiratory therapist.
Taking a test before a COPD 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.
When the environmental reading is enabled, background CO
levels are considered 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
considered.
For example, if the environmental monitor is ON and a reading of
10 ppm is detected and the patient records 3 ppm, then the
measurement displayed will be the higher value i.e. 10 ppm.
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 is a hand held portable
battery-operated device used for measuring the carbon monoxide
(CO) concentration on the breath, calculating the percentage of
carboxyhemoglobin (%COHb) in the blood and for the CO Check

4
+ Baby, also the percentage of fetal carboxyhemoglobin
(%FCOHb).
They are specifically designed as a screening tool for smoking
cessation.
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 carboxyhemoglobin (%COHb) and the
percentage of fetal carboxyhemoglobin (%FCOHb) - (CO Check+
Baby only).
Accessories
There are various accessories available for use with the CO
Check+ / CO Check+ Baby device. The device may be used with
either a standard 22 mm disposable cardboard mouthpiece and
adapter or the SafeBreathTM filtered mouthpiece to eliminate the
need for an adapter and to ensure maximum hygiene and avoid
any risk of cross contamination. SafeBreath disposable cardboard
filtered mouthpieces have a proven bacterial/viral efficacy >99%.*
Note: All cardboard 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 battery by removing the battery cover and clipping
the battery in place, replace the battery cover. Insert the
SafeBreath cardboard filtered mouthpiece or if not using a
SafeBreath mouthpiece, insert the plastic mouthpiece adapter
followed by a cardboard mouthpiece.
Turn the CO Check+ /CO Check+ Baby ON by pressing Power
key .The device will display CO then the version number (ex.
4r) before starting the countdown timer of 15 seconds (CO
Check+) and 10 seconds (CO Check+ Baby).

5
Encourage the subject to hold their breath until the unit beeps to
start the test. The display will show the blow icon.
The subject should place their lips around the 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+ / CO Check+ Baby will beep and show the final
reading in PPM (parts per million).
By pressing the Select Function key the reading changes to
%COHb (carboxyhemoglobin).
and then press Select Function key to display % FCOHb (fetal
carboxyhemoglobin) - (CO Check Baby only)
Pressing again reverts back to PPM.

6
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.
Operation (Environmental Mode Enabled)
Insert the 9V battery by removing the battery cover and clipping
the battery in place, replace the battery cover. Insert the
SafeBreath cardboard filtered mouthpiece or if not using a
SafeBreath mouthpiece, insert the plastic mouthpiece adapter
followed by a cardboard mouthpiece.
Turn the CO Check+/CO Check+ Baby ON by pressing Power
key. The device will display CO then the version number (ex. 4r)
before starting the countdown timer.
The unit will countdown for 10 seconds to ensure the sensor is
stabilized.
When the countdown timer reaches zero, it will display the current
environmental reading

7
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 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+/CO Check+ Baby will beep and show the final
reading in PPM (parts per million).
By pressing the Select Function key the reading changes to
%COHb (carboxyhemoglobin).
and then press Select Function key to display % FCOHb (fetal
carboxyhemoglobin) - (CO Check Baby only)

8
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+ / CO Check+ Baby 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 page 13 for non-
alcohol wipes.
The battery should be changed when the word ‘BAT’
appears on the display.
All mouthpieces including SafeBreath™mouthpieces, are
single patient use and should be disposed of after each
patient –using the same mouthpiece for different patints
will increase the risk of cross contamination between
patients.
Please only use accessories supplied by Micro Direct, Inc.
to ensure the device performs as intended.

9
Calibration
The device should be recalibrated once a month. Calibration gas
can be purchased from Micro Direct, Inc. see page14 for full
ordering details.
To calibrate the device, perform the following steps:
1. Connect the control valve (Cat. No. MC22) to the 20ppm
gas cylinder. (Cat. No. MC10) calibration gas cylinder
shown in the diagram above.
2. Connect the short plastic tubing reducing connector (Cat.
No. MEC1007).

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3. Put the device into calibration mode by pressing the
Select Function key and turning the device on .
Keep the select key pressed until the device displays ‘Cb’.
Release the select 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 knob will not turn any further. The supply
of gas is .25L/minute.
6. Apply this flow until the device beeps after 20 seconds
then turn the gas off. The device will display the gas
concentration reading.
7. If the reading is not 20 ppm, press the Select Function
key for at least 3 seconds to accept the new
calibration value. The device will say ‘dn’ (done) and then
will show 20 ppm.
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)

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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, release the Select Function key .At the end of the
countdown, the unit will display ‘EN’ for 3 seconds following by
either ‘OF’ (Off) – your current setting or ‘ON’ (On).

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Press the Select key momentarily (< 0.5 sec), to change the
mode.Press the Select key for more than 3 seconds to accept
the mode either ‘ON’ or ‘OF”. Thereafter the unit will restart with
your selected setting.
Battery Life
The 9V 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.
The device will need recalibration after the replacement of the
battery. Duracell notification - Alkaline batteries can be safely
disposed of with normal household waste. Never dispose of
batteries in fire because they could explode.
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. Do not remove the
battery unless the device is not going to be used for a very long
time. Remember, calibration will be required when the battery is
reconnected.

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To prevent the device from switching off, press the Select
Function key within three minutes of the last press or when
the reading is first displayed.
Cleaning
The plastic adapters should be replaced on a monthly basis or
after 250 tests (whichever is sooner). Between tests the adapter
may be immersed in a cold disinfection solution or mild detergent
sterilization solution then MUST be thoroughly rinsed in water and
dried completely before reuse.
The device can be cleaned using non-alcohol wipes (see page
14). Please be certain not to touch the surface of the sensor or
allow moisture to do the same.
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 Micro
Direct, Inc.
The CO Sensor should be replaced every two years.
If the device starts with ‘Er’ (Error) message, it should be
returned for service.
Email: [email protected]
Tel: [phone] or 207-786-7808

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Consumables
Catalog
Number
Description
MC15
CO Calibration Kit (includes 20 ppm gas)
MC10
CO Replacement Tank (17 Liters)
MC22
Control Valve for Calibration
FM200
SafeBreathTM Mouthpieces (Box of 200)
3301
CO Mouthpieces (Bag of 100)
PSA1800
Intermediate Plastic Adapters
CS101
Soft Shell Carry Pouch
48-70
Protex Disinfectant Wipe
FC50
Fuel cell for CO Check+ / CO Check+ Baby
Specifications
Gas Detected Carbon Monoxide
Concentration Range 0-99 PPM
Detection Sensor Used Electrochemical fuel cell
Sensitivity 0.1 PPM (0-10 PPM range); 1
PPM (10-99PPM range)
Accuracy (repeatability) 2ppm
Operating Temperature 41 - 95 degrees F
Operation pressure Atmospheric 10%
Operating Humidity 30% to 90% RH
Operating Altitude Sea level to 6000 ft
Storage Temperature 68 - 158 degrees F
Storage Humidity 10% to 90% RH
Hydrogen cross-sensitivity <12% at 68 degrees F
Sensor Life 2 - 5 years, 2 years warranty
Sensor Drift <2% per month
Display Custom LCD
Power Supply Single 9V battery
Weight Approximately Approximately 5 ounces
Dimensions 5” x 2.5” x 1.25”

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Symbols
In accordance with Directive 93/42/EEC
0120
Type B Device
To avoid the potential effects on the environment and human
health as a result 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.
In order 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.

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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 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

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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.

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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
Complian
ce 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 distance
d = [ 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 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 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