Related Manuals for Bedfont Smokerlyzer Series
Summary of Contents for Bedfont Smokerlyzer Series
- Page 1 Smokerlyzer Range ® For use with piCO , piCO and Micro babyTM User manual 0086 Our family, innovating health, for yours.
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Page 2: Table Of Contents
Contents Intended use ............................ 2 Introduction ............................ 2 Taking a breath test .......................... 2 Conducting an ambient test – Micro ™ only .................. 3 Reviewing history – Micro ™ only ...................... 3 Changing date and time – Micro ™ only .................... 3 Traffic light pre-set cut-off levels ....................... 4 Technical specification ........................ 4 Safety information and device symbols ..................... 5 Environment ............................ 6 Instrument layout .......................... 7 Display and device symbols ........................ 8 Warnings and maintenance ...................... 1 Cleaning . -
Page 3: Intended Use
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 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 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) . 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 baby The piCO™ Smokerlyzer® displays both CO ppm and %COHb, the piCO ™ Smokerlyzer® displays both CO ppm,%FCOHb and %COHb and the Micro ™ 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 breath- holding. 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 in- line 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, 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... -
Page 4: Conducting An Ambient Test - Micro + ™ Only
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 to increase and decrease. Press to save your settings. -
Page 5: Traffic Light Pre-Set Cut-Off Levels
Traffic light pre-set cut-off levels Traffic light colour Description Reading (ppm) baby piCO™ & Micro ™ piCO ™ Green Non-smoker 0-6 0-3 Amber Borderline 7-9 4-6 1 Red Smoker – low addicted 10-15 7-10 2 Red Smoker – moderately addicted 16-25 11-15 3 Red Smoker – heavily addicted 26-35 16-25 3 Red Flashing Smoker – very heavy addicted 36+ 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 baby piCO™ piCO ™... -
Page 6: Safety Information And Device Symbols
Safety information and device symbols Degree of protection against electric shock Type BF applied part Type of protection against electric shock Internally powered equipment Degree of protection against ingress of liquid IPXO - not protected against water ingress Degree of safety application in the presence of a Equipment not suitable for use in the flammable anaesthetic mixture with air, oxygen presence of flammable mixtures. or nitrous oxide Refer to manual Direct current CE mark Type BF applied part Dispose of according to WEEE Serial number Manufacture by and date Bedfont® logo... -
Page 7: Environment
Environment baby The piCO™, piCO ™ 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. Guidance and manufacturer’s declaration: Electromagnetic Immunity (IEC 60601-1-2) The Smokerlyzer® monitors are intended for the use in the electromagnetic environment specified below. The customer or the user of the Smokerlyzer® should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment – guidance Radiated Emissions 30MHz to 1GHz Met or exceeded EN55011:2007 Radiated Immunity 10V/m (1kHz 80%) 80MHz – Met or exceeded Interference may occur in EN61000-4-3:2006 + 2.7GHz the vicinity of equipment A1:2008 + IS1 2009 + 385 MHz 27 V/m PM 18 Hz marked with the following A2:2010 450 MHz 28 V/m FM 1 kHz sine symbol: 710 MHz 9 V/m PM 217 Hz 745 MHz 9 V/m PM 217 Hz 780 MHz 9 V/m PM 217 Hz 810 MHz 28 V/m PM 18 Hz 870 MHz 28 V/m PM 18 Hz 930 MHz 28 V/m PM 18 Hz 1720MHz 28 V/m PM 217 Hz 1845 MHz 28 V/m PM 217 Hz 1970 MHz 28 V/m PM 217 Hz... -
Page 8: Instrument Layout
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 ™ software) 7. Single-use SteriBreath™ mouthpiece 8. Battery compartment 9. Battery compartment clip 10. Reset button 11. Programming switch... -
Page 9: Display And Device Symbols
Display and device symbols baby Description piCO™ piCO ™ Micro ™ Battery condition: full Battery condition: low Battery condition: empty Breath test Environmental test N/A N/A Settings Patient profiles N/A N/A View patient results N/A N/A Inhale Hold breath Countdown timer Exhale ppm reading %COHb reading Show %FCOHb N/A... - Page 10 baby Description piCO™ piCO ™ Micro ™ %FCOHb reading N/A Ambient CO reading N/A N/A Home Change D-piece™ Change traffic light cut-off levels Save N/A N/A Change breath-hold time N/A N/A History N/A N/A Mute Next step Low temperature High temperature Countdown to sensor change...
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Page 11: Warnings And Maintenance
Change sensor Calibrate device baby Description piCO™ piCO ™ Micro ™ Attach flow meter to gas canister 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. -
Page 12: Cleaning
Cleaning 1. The Smokerlyzer® products are moulded with SteriTouch® technology for optimum infection control and bacterial efficacy. However Bedfont® recommends wiping the instrument and D- piece™ 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 baby piCO™, piCO ™ 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:... - Page 13 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, , to start a breath test. 4. When prompted by the ‘exhale’ symbol, , 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 symbol 5 times and then once to proceed 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...
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Page 14: 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. -
Page 15: Spares
. 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. OneBreath™ mouthpieces: 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 one- way valve and an infection control filter, which are proven to remove and trap >99.9% of airborne bacteria Monitor cleaning wipes: Free from alcohol to ensure continued performance of your monitor. Products containing alcohol cannot be used on any of the Smokerlyzer® range. Warranty baby Bedfont® Scientific Limited warrants the piCO™, piCO ™ 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. - Page 16 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...
- Page 17 Tel: +44 (0)1622 851122 Fax: +44 (0)1622 854860 Email: ask@bedfont.com © Bedfont® Scientific Limited 2018 Issue 4- December 2018 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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