Bedfont Micro+ Smokerlyzer Series User manual

Smokerlyzer® Range
User manual
Our family, innovang health, for yours.
For use with Micro Smokerlyzer

1
Important Information/Reminders
WARNING: Please read the manual before use.
WARNING: Never use alcohol or cleaning agents containing alcohol or other organic solvents as
these vapours will damage the electrochemical sensor inside.
WARNING: Under no circumstances should the instrument be immersed or splashed with liquid.
WARNING: Breath tests must only be carried out with Bedfont® accessories. Failure to do so may
cause incorrect readings.
WARNING: The mouthpieces are single patient use only and can be used for a maximum of 3 tests.
Further re-use could cause incorrect readings and could increase the risk of cross infection. The
mouthpiece should be disposed of after use, in accordance with local waste disposal guidance.
WARNING: Patients should exhale for the duration of time indicated by the monitor during a breath
test. Failure to do so may cause incorrect readings.
WARNING: To ensure a breath sample is taken at the correct flow rate, the monitor must be held
upright at all times during a breath test.
WARNING: Do not block the exhaust ports on the device at any time. Blocking the exhaust ports may
cause erroneous readings.
WARNING: Avoid exposure to known sources of EMI (electromagnetic interference) such as
Magnetic Resonance Imaging (MRI) systems, diathermy, lithotripsy, electrocautery, RFID (Radio
Frequency Identification), and electromagnetic security systems such as metal detectors.
Keep the Smokerlyzer® outside the MRI scanner room.
CAUTION: Ensure the monitor is used within the stated operating temperature and humidity ranges.
Operating temperature is 15-40oC. Operating humidity is 15-90% RH (non-condensing).
CAUTION: Portable and mobile RF communications equipment can affect the Smokerlyzer®
monitors.
NOTE: See Bedfont’s infection control and maintenance guidelines for further information on
infection control.
NOTE: Please do not attempt to modify the equipment in any way or use accessories not specified
by the manufacturer. Any attempt to do so, will invalidate the warranty and may compromise the
safety of the device.
NOTE: Bedfont® will make available on request service training to appropriately qualified personnel.

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Contents
Important Information/Reminders.....................................................................................................1
Introduction ........................................................................................................................................3
Definitions...........................................................................................................................................3
Compliance .........................................................................................................................................3
Intended Use.......................................................................................................................................3
Contraindications................................................................................................................................3
Instrument Layout...............................................................................................................................4
User Interface .....................................................................................................................................5
Taking a breath test ............................................................................................................................5
Conducting an ambient test................................................................................................................8
Patient Profiles....................................................................................................................................9
Reviewing history..............................................................................................................................11
Changing date and time....................................................................................................................11
Changing breath holding time ..........................................................................................................12
Changing breath testing thresholds..................................................................................................14
Maintenance Reminders...................................................................................................................15
Maintenance.....................................................................................................................................16
Calibration.........................................................................................................................................17
Technical Specification......................................................................................................................21
Safety Information and Device Symbols...........................................................................................22
Environment .....................................................................................................................................22
COdata+™ software – connecting to the PC......................................................................................23
Buttons..............................................................................................................................................24
Troubleshooting................................................................................................................................27
Warranty...........................................................................................................................................30
Returns..............................................................................................................................................30
Responsible Manufacturer and Contacts..........................................................................................31

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Introduction
The User Manual provides instructions on how to operate the Micro+™ Smokerlyzer® monitor and its
accessories. It contains relevant information about the monitors, its uses and its care, including step-
by-step instructions with screens and illustrations.
The Micro+™ Smokerlyzer® displays CO ppm, %COHb and %FCOHb. Devices only directly measure CO
ppm, the %COHb and %FCOHb is a calculation based on clinical evidence. Clinical research has
demonstrated that a useful relationship between carbon monoxide and carboxyhaemoglobin is
obtained after a short period of breath-holding.
Definitions
WARNING: indicates a potentially hazardous situation, which, if not avoided, may result minor or
moderate injury.
CAUTION: indicates a potentially hazardous situation, which, if not avoided, may result in damage to
the device.
NOTE: used to call attention to notable information that should be followed during use.
Compliance
The Micro+™ Smokerlyzer® monitor is CE marked according to the Medical Device Directive
93/42/EEC as amended by 2007/47/EC.
Please refer to the ‘Safety Information’ section of this manual for more information on the
compliance of the Smokerlyzer® monitors.
Intended Use
The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient
use by healthcare professionals in smoking cessation programmes and research. It can also be used
as an indicator of carbon monoxide poisoning in a healthcare environment.
Contraindications
There are no known contraindications.

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Instrument Layout
1. Power button
2. USB port (for use with COdata+™
software)
3. Display
4. D-piece™ aperture
5. Battery compartment clip
6. Battery compartment
7. Exhaust port
8. Manufacturer label
9. Exhaust port
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2
4
3
5
6
7
8
9

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User Interface
Home Screen
1. Battery status
2. Maternity breath test
3. Normal breath test
4. Ambient air test
5. Patient profiles
6. Settings
Taking a breath test
Attach a breath sampling D-piece™ and new
SteriBreath™ Eco mouthpiece.
Turn on the monitor by pressing the power button once.
Press the breath test icon on screen, either the male or
female symbol.
1
2
3
4
5
6

6
Inhale and hold breath for the pre-set 15 second
countdown.
Press the home button at any time to cancel the breath
test.
A beep will sound during the last three seconds of the
countdown.

7
Blow slowly into mouthpiece, aiming to empty lungs
completely.
The ppm and equivalent %COHb and/or %FCOHb levels
will rise and hold onscreen.
When the test is finished, the volume, home and save
icons will appear at the bottom of the screen.

8
If a high reading has been recorded, the monitor can muted by the sound by pressing the volume icon.
To repeat breath test, press the home icon once to return to the home screen and repeat steps 3-8.
To save the reading, press the save icon and select the relevant patient profile.
Remove the D-piece™ between tests to purge sensor with fresh air.
To switch off, press and hold the power button for 3 seconds, unit will also power off after 2 minutes of
inactivity to save power.
Conducting an ambient test
The environmental air can be tested to
check for CO in the environment using the
Micro+™ Smokerlyzer®. This is particularly
useful in the event of a patient reporting a
non-smoker status but providing a breath
reading of that of a smoker suggesting they
have inhaled environmental CO.
This is carried out by pressing the ambient
mode icon on the screen.
The Micro+™ will then carry out real-time
monitoring of the environmental air. To stop
the test, press the home icon.

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Bedfont® does not recommend that the environmental test alone is used as a measure of passive smoking
as the very high dispersiveness of CO at the levels involved with smoking can lead to false negative
readings.
Patient Profiles
All patient profiles saved on the device will
be listed here. To view patient information,
press the relevant patient profile block.
If ‘start breath test’ is selected from this
screen, the breath test will be automatically
saved to the profile. Once the type of breath
test has been assigned to the patient, only
one symbol will appear.

10
To change the name of the patient, press
the text box icon, then press the letters
required. Click the save icon to confirm or
the home icon to return to the home screen.
To access the patient’s breath test results
history, press the graph icon. This will then
bring up the patient’s testing history.
To delete a patient profile, press the delete
icon. To confirm, press the delete icon
again.

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Reviewing history
The Micro+™ will record every reading taken
in its history up to 150 readings, to access
this press the settings icon.
Bedfont® does not recommend that the environmental test alone is used as a measure of passive smoking
as the very high dispersiveness of CO at the levels involved with smoking can lead to false negative
readings.
Changing date and time
Press the settings icon.

12
Press the date/time icon.
Select either d-m-y or m-d-y for
the date format and 12h or 24h
for the time format.
Dates and times are then
adjusted by selecting the
number needing changed and
pressing the up or down arrow
icons to increase and decrease.
Press the save icon to save the
new settings.
Changing breath holding time
Press the settings icon.

13
Press the breath holding time
icon.
Use the arrows to adjust the
breath holding time. Press the
save icon to save changes.

14
Changing breath testing thresholds
Traffic light
colour
Description
Reading (ppm)
Green
Non-smoker
0-6
Amber
Borderline
7-9
1 Red
Smoker –low
addicted
10-15
2 Red
Smoker –
moderately
addicted
16-25
3 Red
Smoker –heavily
addicted
26-35
3 Red
Flashing
Smoker –very
heavy addicted
36+
This table shows the pre-set
breath testing thresholds.
Press the settings icon.
To change the breath test
thresholds, press the traffic
light icon.

15
Once adjusted, press the save
icon.
Maintenance Reminders
Change D-piece™ reminder
The D-piece™ requires changing
every 30 days. This reminder is
displayed at switch on.
Sensor change reminder
This reminder is displayed at
switch on when the sensor is
nearing its change date.
After 60 days of this reminder
being displayed, the ‘red date’
alarm takes over.

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Sensor change overdue
reminder
This reminder is displayed at
switch on when the sensor
requires replacing. This
reminder cannot be bypassed.
Maintenance
Routine maintenance
1. Mouthpieces should be replaced after every use.
2. Hands should be washed regularly in accordance with infection control practice.
3. Please do not attempt to modify the equipment in any way or use accessories not specified
by the manufacturer. Any attempt to do so will invalidate the warranty and may
compromise the safety of the device.
4. Bedfont® will make available upon request service training to appropriately qualified
persons.
5. The Micro+™ Smokerlyzer® requires calibrating every 6 months.
6. Holding the reset button down for 30 seconds will perform complete device reset, this will
clear any saved data and revert all settings to the factory defaults. After performing a reset
the device will need to have the date/time set and be calibrated before it can be used.
7. Replace batteries when indicated by the empty symbol.
8. Bedfont® recommend removal of the batteries when the device is not used for prolonged
periods of time to prevent leakage.
9. Replace breath sampling D-piece™every 30 days or if visibly soiled or contaminated. The
Micro+™ Smokerlyzer® will give a reminder during start-up when the D-piece™should be
replaced, see ‘change D-piece™’ symbol.
10. The sensor should be replaced every 5 years, 60 days prior to the sensor change ‘countdown
to sensor change’ symbol will be shown with the date on which the sensor should be
changed. This can be ignored by pressing the home icon until the date at which the sensor
should be changed arrives, at this point the ‘change sensor’ symbol will be shown. Change
sensor if trained to do so by an approved Bedfont® engineer or send to Bedfont® or the local
representative.

17
Cleaning
1. The Smokerlyzer® products are moulded with SteriTouch® technology for optimum
infection control and bacterial efficacy. Bedfont®recommends wiping the instrument
and D-piece™external surfaces between each patient with an alcohol-free wipe
specifically designed for this purpose. A list of approved wipes can be found here:
https://www.bedfont.com/cleaning-bedfont-monitors. The D-piece™ cannot be
sterilised.
2. NEVER use alcohol or cleaning agents containing alcohol or other organic solvents as
long term exposure to these vapours will damage the CO sensor inside.
3. Under no circumstances should the instrument be immersed in liquid or splashed with
liquid
Calibration
The Smokerlyzer® monitors must be calibrated within 17-25°C. If it is too cold to calibrate (<17°C) a
blue thermometer will be shown onscreen.
Move the Smokerlyzer® to a warmer area and try again later. If it is too hot to calibrate (>25°C) a red
thermometer will be shown onscreen. Move the Smokerlyzer® to a cooler area and try again later.
Turn on the monitor by pressing
the power button once.
Press the settings icon.

18
Press the calibration icon once
to enable.
Once this has been successfully
carried out the device will
perform a zero; do not apply
gas at this stage.
The first step of the calibration
process will be shown onscreen;
follow the onscreen instructions
to finish the calibration process.

19
1. Ensure the fine control
valve is in the off
position.
2. Screw the fine control
valve and flow indicator
assembly to the gas
can. This is best done by
screwing the gas can
into the valve.
3. Press ‘breath test’
symbol on screen to
start a breath test.
4. When prompted by the
‘exhale’ symbol, open
the fine control valve or
regulator.