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Sm
o
ker
lyzer
®
Range
For use with piCO
TM
, piCO
babyTM
and Micro
+TM
User manual
0086
Our family, innovating health, for yours.
Contents
Conducting an ambient test – Micro
™ only ...................................................................................... 3
Changing date and time – Micro
1
Intended use
The piCO™, piCO baby
™ and Micro
+
™ Smokerlyzer® products are breath carbon monoxide monitors intended for multi-patient use by healthcare professionals in smoking cessation programmes and research. They can also be used as an indicator of carbon monoxide poisoning in a healthcare environment.
Introduction
Carbon monoxide (CO) is a toxic, odourless, colourless and tasteless gas
1
. It is formed by the incomplete combustion of organic material at high temperatures, with an insufficient oxygen supply.
When inhaled, CO displaces oxygen in the bloodstream to form carboxyhaemoglobin (COHb). This starves body tissue of oxygen restricting the body’s performance and causing health implications
2
.
CO can remain in the bloodstream for up to 24 hours, depending on factors such as physical activity, sex, and inhalation intensity. The half-life is about 5 hours
3
.
CO (ppm), carboxyhaemoglobin (%COHb) and foetal carboxyhaemoglobin (%FCOHb) correlation:
Breath carbon monoxide is measured in parts per million (ppm) and blood carboxyhaemoglobin is measured in percentages (%COHb and %FCOHb)
4
. The three are compatible and convertible: the ppm CO reading relates to gas in the lungs and on the breath (i.e. the amount of poisonous CO that has been inhaled), and the %COHb and %FCOHb readings relate to the percentage of vital oxygen that has been replaced in the bloodstream
4
.
The piCO™ Smokerlyzer® displays both CO ppm and %COHb, the piCO both CO ppm,%FCOHb and %COHb and the Micro
+ baby
™ Smokerlyzer® displays
™ Smokerlyzer® displays CO ppm, %COHb and
%FCOHb. However all 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 breathholding.
The cut-off point between smoker and non-smoker differs based on local regulation, Bedfont® have created cut-off levels as a guide only, see ‘traffic light pre-set cut-off levels’, these can be altered inline with your local regulations from the settings screen.
Taking a breath test
1. Attach a breath sampling D-piece™ and new SteriBreath™ mouthpiece
2. Turn on the monitor by pressing the power button once
3. Press ‘breath test’ symbol on screen, or
4. To cancel the breath test, press
5. Inhale and hold breath for the pre-set 15 second countdown
6. A beep will sound during the last three seconds of the countdown.
7. Blow slowly into mouthpiece, aiming to empty lungs completely
2
8. The ppm and equivalent %COHb and/or %FCOHb levels will rise and hold onscreen.
9. On the piCO™ and piCO baby
™, when the test is finished will appear at the bottom of the screen
10. On the Micro
+
™, when the test is finished will appear at the bottom of the screen
11. If a high reading has been recorded, you can mute the sound by pressing
12. To repeat breath test, press once to return to the home screen and repeat steps 3-8
13. To save the reading (Micro
+
™ only) press and select the relevant patient profile
14. Remove the D-piece™ between tests to purge sensor with fresh air
15. 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 – Micro
+
™ only
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 on the screen; the Micro
+
™ will then carry out real-time monitoring of the environmental air. To stop the test, press .
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.
Reviewing history – Micro
+
™ only
The Micro
+
™ will record every reading taken in its history up to 150 readings, to access this press and then the history will then be shown.
Changing date and time – Micro
+
™ only
Press and then you can then 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 you wish to change and pressing or to increase and decrease. Press to save your settings.
3
Traffic light pre-set cut-off levels
Traffic light colour
Green
Amber
1 Red
2 Red
3 Red
3 Red Flashing
Description Reading (ppm)
piCO™ & Micro
+
™
piCO baby
™
Non-smoker
Borderline
0-6
7-9
Smoker – low addicted 10-15
Smoker – moderately addicted 16-25
Smoker – heavily addicted 26-35
Smoker – very heavy addicted 36+
0-3
4-6
7-10
11-15
16-25
26+
To adjust the pre-set cut off levels, press from the settings menu and drag the cut off levels up and down to the desired ppm level. These settings will remain until adjusted again.
Technical specification
Concentration range
Display
Detection principle
Repeatability
Accuracy
Power
T
90
response time
Operating temperature
Storage/transport temperature
Operating/storage/transport pressure
Operating humidity
Storage/transport humidity
Sensor operating life
Sensor sensitivity
Sensor drift
Dimensions
Weight
Materials
H
2
cross interference
*whichever is greater
piCO™
0-150ppm
piCO baby
™
0-150ppm
Full colour touchscreen
Electrochemical sensor
Micro
+
™
0-500ppm
<±5%
2ppm/5%*
3 x AA (LR6 or equivalent) – up to 1000 minutes
1 x CR2032 Lithium coin cell
<30 seconds
15-40°C
0-50°C
Atmospheric ±10%
15-90% non-condensing
0-95%
5 years
1ppm
<2% per month
Approx. 37 x 77 x 140 mm
Approx. 215g (including batteries)
Case: polycarbonate/ABS blend
SteriTouch® anti-microbial additive
D-piece™: polypropylene
SteriBreath™: polypropylene
≤6%
4
Safety information and device symbols
Degree of protection against electric shock
Type of protection against electric shock
Degree of protection against ingress of liquid
Degree of safety application in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide
Refer to manual
Type BF applied part
Internally powered equipment
IPXO - not protected against water ingress
Equipment not suitable for use in the presence of flammable mixtures.
Direct current
CE mark
Type BF applied part
Dispose of according to WEEE
Serial number
Manufacture by and date
Bedfont® logo
Environment
The piCO™, piCO baby
™ and Micro
+
™ Smokerlyzer® products comply with the directive EN60601-1-2 electromagnetic compatibility but can be affected by cellular phones and by electromagnetic interference exceeding the levels specified in EN50082:1. This equipment should be moved if necessary to avoid interference.
5
Instrument layout
1. Display
2. Power button
3. Breath sampling D-piece™
4. D-piece™ aperture
5. Exhaust port for breath sample
6. USB connector
(for use with COdata
7. Single-use SteriBreath™ mouthpiece
8. Battery compartment
9. Battery compartment clip
10. Reset button
11. Programming switch
+
™ software)
6
Display and device symbols
Description
Battery condition: full
Battery condition: low
Battery condition: empty
Breath test
piCO™
piCO baby
™
Environmental test
Settings
Patient profiles
View patient results
Inhale
N/A
N/A
N/A
N/A
N/A
N/A
Hold breath
Countdown timer
Exhale ppm reading
%COHb reading
Show %FCOHb
N/A
Micro
+
™
7
Description
%FCOHb reading
Ambient CO reading
Home
Change D-piece™
Change traffic light cut-off levels
Save
Change breath-hold time
History
Mute
Next step
Low temperature
N/A
N/A
N/A
piCO™
N/A piCO baby
™
N/A
N/A
N/A
N/A
N/A
High temperature
Countdown to sensor change
Micro
+
™
8
Change sensor
Calibrate device
Description
Attach flow meter to gas canister
piCO™
piCO baby
™
Micro
+
™
Attach calibration adaptor to D-piece™
Attach D-piece™ to monitor and turn on gas flow
Unit calibrating
Calibration successful
Calibration failed
Retry calibration
Firmware version
N/A = Not Available on this device
Warnings and 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. 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.
9
Cleaning
1. The Smokerlyzer® products are moulded with SteriTouch® technology for optimum infection control and bacterial efficacy. However Bedfont® recommends wiping the instrument and Dpiece™ external surfaces with a product specifically developed for this purpose. Bedfont® provides instrument cleaning wipes. 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.
Routine maintenance
1. Replace batteries when indicated by the empty symbol .
2. Bedfont® recommend removal of the batteries when the device is not used for prolonged periods of time to prevent leakage.
3. Replace breath sampling D-piece™ every 30 days or if visibly soiled or contaminated. The piCO™, piCO baby
™ and Micro
+
™ Smokerlyzer® products will give a reminder during start-up when the D-piece™ should be replaced, see ‘change D-piece™’ symbol.
4. 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 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 by an approved Bedfont® engineer or send to Bedfont® or the local representative.
5. Additional technical information can be made available on request; please contact Bedfont® or its distributor.
Troubleshooting
The unit fails to turn on:
If the unit fails to turn on properly, check if the low or empty battery symbols are shown or replace the batteries. Ensure that the batteries are inserted the correct way around, matching the symbols moulded into the plastic.
High readings recorded for reported non-smoker:
If a breath test on a non-smoker gives an indication of CO being present, it may indicate the following:
1. A high ambient level of CO (possibly due to a faulty combustion appliance or exhaust fumes).
2. The effects of passive smoking.
3. The device is contaminated by alcohol or another organic substance.
10
4. The patient may have a very high level of hydrogen on their breath, which can be generated in the human digestive system.
5. The sensor may have drifted out of specification (see below).
The sensor has drifted out of specification:
Smokerlyzer® products are calibrated before leaving Bedfont®, however we recommend if you suspect the instrument is reading incorrectly, try the test again with another device if available to get a comparison. Alternatively you check the function using Bedfont® check gas or send back to
Bedfont®. The check gas required is Bedfont® 20ppm carbon monoxide in air, procedure below.
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, or , to start a breath test.
4. When prompted by the ‘exhale’ symbol, or , open the fine control valve or regulator and allow the gas to flow at 1 litre per minute.
5. Allow the gas to flow through the instrument for the duration of the test, again monitoring the rate of flow.
6. If the final displayed value is less than 15ppm or higher than 25ppm, stop the test and perform a calibration or send back to Bedfont® for a free of charge calibration, following the instructions below.
Calibration procedure:
1. Turn on the monitor by pressing the power button once
2. Press
3. Start the calibration process, pressing the proceed symbol 5 times and then once to
4. If the temperature of the monitor is too low to calibrate, the blue thermometer will be shown . Try again later once the unit has warmed up – if this problem persists please contact Bedfont® or your local supplier.
5. If the temperature of the monitor is too high to calibrate, the red thermometer will be shown . Try again later once the unit has cooled down – if this problem persists please contact Bedfont® or your local supplier.
6. Once this has been successfully carried out the device will perform a zero; do not apply gas
at this stage
7. The first step of the calibration process will be shown onscreen; follow the onscreen instructions to finish the calibration process
11
8. Gas flow should be set to 1.0 litres per minute
9. A successful calibration will be indicated by the , press to return to the home screen
10. A failed calibration will be indicated by , press to attempt calibration again – if the problem persists see ‘troubleshooting’ or call your local supplier of Bedfont® products
11. Return to the home screen by pressing
COdata
+
™ software – connecting to the PC
Place one end of the connection lead into the USB socket on the top of the Smokerlyzer® product, connecting the other end to the USB port on the PC. Before starting the software, ensure that the
Smokerlyzer® product is connected to the PC and switched on. Double click the COdata
+
™ icon on the PC to start the programme. Refer to the supplied documentation for how to operate COdata
+
™.
Returns procedure
If your equipment requires servicing, please contact your local Bedfont® customer service department, distributor or supplier before returning any goods.
1. When you have supplied the customer repairs department with the monitor serial number and description of the fault, you will be issued with a returns/ ticket number. Please state the returns/ticket number on the outside of the box when returning the monitor, and ensure that your full details, telephone, fax numbers and return address are clearly stated.
2. The product must also be decontaminated before it is returned according to your local regulations. Bedfont® can provide you with a decontamination certificate to complete, which also needs to be attached to the outside of the box. Failure to do so will result in the product being subject to Bedfont® decontamination procedure and will delay your service/repair.
3. Bedfont® advise that you use a courier service when returning monitors. This enables you to insure goods for loss or damage in transit. When your goods are received, you will be sent an email stating so.
4. If the device has been returned for repair it will then be examined and you will be sent an
‘engineer’s report’ and a quotation for the repair, which will include an authorisation form.
Complete the authorisation form, and ensure that you include the ‘official purchase order number’. Please contact the customer repairs department if you are unable to supply an
‘official purchase order number’.
5. If your monitor is still in warranty and the fault is covered by warranty, see ‘warranty’ section of this manual, Bedfont® will repair it and return it to you with an ‘engineer’s report’, free of charge.
6. If you choose not to proceed with the repair, a handling fee will be charged. Ensure that you return the completed authorisation form with an ‘official purchase order number’.
7. The equipment will be returned to you as soon as Bedfont® has received all relevant paperwork. A carriage fee will be charged if the monitor is no longer in warranty.
12
Spares
SteriBreath™ mouthpieces:
D-piece™:
OneBreath™ mouthpieces:
Monitor cleaning wipes:
SteriBreath™ mouthpieces are both cost effective and compact. They are individually sealed for optimum infection control, whilst condensation in the tube confirms an accurate breath sample.
The D-piece™ is used to attach a SteriBreath™ mouthpiece to the monitor. The D-piece™ incorporates a one-way valve and an infection control filter, which are proven to remove and trap >99.9% of airborne bacteria
5
. The D-piece™ should be changed every four weeks or more often if visibly soiled.
An automatic reminder will appear on the screen every 28 days.
The OneBreath™ mouthpiece is a single-use bacterial filter mouthpiece and can be attached directly to the monitor to take a breath sample. The OneBreath™ incorporates a oneway valve and an infection control filter, which are proven to remove and trap >99.9% of airborne bacteria
5
.
Free from alcohol to ensure continued performance of your monitor. Products containing alcohol cannot be used on any of the Smokerlyzer® range.
Warranty
Bedfont® Scientific Limited warrants the piCO™, piCO baby
™ and Micro
+
™ Smokerlyzer® products
(excluding batteries) to be free of defects in materials and workmanship for a period of five years from the date of shipment. Bedfont’s sole obligation under this warranty is limited to repairing or replacing, at its choice, any item covered under this warranty when such an item is returned, intact and prepaid, to Bedfont® or the local representative.
These warranties are automatically invalidated if the products are repaired; altered, void labels removed or otherwise tampered with by unauthorised personnel, or have been subject to misuse, neglect or accident.
Never dispose of any electronic instrument or batteries in domestic waste. At the end of the product’s life, contact Bedfont® or its distributor for disposal instructions.
References
1. Carbon Monoxide Poisoning — NEJM [Internet]. New England Journal of Medicine. 2017
[cited 14 March 2017]. Available from: http://www.nejm.org/doi/full/10.1056/NEJM199811263392206
2. Andrew H. Carbon Monoxide ‘The Silent Killer’ Feasibility Study 2009/2010. 1st ed. London:
London Ambulance; 2017
3. Craig Smollin K. Carbon monoxide poisoning (acute) [Internet]. PubMed Central (PMC). 2017
[cited 14 March 2017]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3217756/
13
4. Stewart RD e. Rapid estimation of carboxyhemoglobin level in fire fighters. - PubMed - NCBI
[Internet]. Ncbi.nlm.nih.gov. 2017 [cited 17 March 2017]. Available from: https://www.ncbi.nlm.nih.gov/pubmed/946082
5. Health Protection Agency (HPA). Porton Down, Report No. 43/06. Pp. 10-11
14
est. 1976
Contact Bedfont® or one of our worldwide Sm o ker lyzer
®
distributors for a free demonstration.
www.bedfont.com
Tel:+44 (0)1622 851122
Email: [email protected]
A full list of our worldwide distributors can be found at http://www.bedfont.com/uk/english/distributors
Our family, innovating health, for yours.
Bedfont® Scientific Ltd.
Station Road, Harrietsham, Maidstone,
Kent, ME17 1JA England
Tel: +44 (0)1622 851122 Fax: +44 (0)1622 854860
Email: [email protected]
© Bedfont®Scientific Limited 2017
Issue 3- March 2017 Part No: LAB679
Bedfont® Scientific Limited reserves the right to change or update this literature without prior notice.
Registered in: England and Wales. Registered No: 1289798
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