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Compliance

The ToxCO® monitor is CE marked according to the Medical Device Directive 93/42/EEC.

Please refer to the ‘Safety Information’ section of this manual for more information on the
compliance of the ToxCO® monitor.

Intended Use

The ToxCO® breath Carbon Monoxide monitor and its accessories are used in the screening of
Carbon Monoxide (CO) poisoning and calculation of the carboxyhaemoglobin (COHb) level. The
ToxCO® breath Carbon Monoxide monitor can be used by health professionals in medical institutions
and emergency medical services where Carbon Monoxide exposure is suspected for paediatric,
adult, and unconscious patients.

Contraindications

There are no known contraindications.

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Содержание ToxCO

Страница 1: ...User manual ToxCO Helping to determine levels of CO poisoning ...

Страница 2: ... 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 CAUTION Ensure the monitor is used within the stated operating temperature and humidity ranges Operating temperature is 15 35o C Operating humidity is 25 80 RH non condensing CAUTION Portab...

Страница 3: ...Adjusting test thresholds 16 Enabling disabling ppm readings 18 Reviewing history 21 Changing date time 22 Changing breath hold time 23 Technical Specification 25 Safety information and device symbols 25 Environment 26 Device and display symbols 27 Maintenance 30 Calibration 32 Troubleshooting 36 ToxCOdata software connecting to the PC 37 Returns procedure 38 Spares 39 Warranty 39 Appendix 40 Refe...

Страница 4: ...levels of poisonous inhaled CO while the COHb reading shows the percentage of vital oxygen that has been replaced in the bloodstream7 Clinical research has demonstrated that the concentration of carbon monoxide in end expired air after breath holding correlates closely with carboxyhaemoglobin concentration 3 Operation of the ToxCO is straightforward a D piece sampling system and face mask sampling...

Страница 5: ...O breath Carbon Monoxide monitor and its accessories are used in the screening of Carbon Monoxide CO poisoning and calculation of the carboxyhaemoglobin COHb level The ToxCO breath Carbon Monoxide monitor can be used by health professionals in medical institutions and emergency medical services where Carbon Monoxide exposure is suspected for paediatric adult and unconscious patients Contraindicati...

Страница 6: ...ampling D piece 4 D piece aperture 5 Exhaust port for breath sample 6 USB connector for use with ToxCOdata software 7 Single use SteriBreath mouthpiece 8 Battery compartment 9 Battery compartment clip 10 Reset button 11 Programming switch 12 USB cable 1 0m ...

Страница 7: ...6 User Interface Home Screen 1 Battery status 2 Face mask breath test 3 Normal breath test 4 Ambient test 5 Patient profiles 6 Settings 1 2 3 4 5 6 ...

Страница 8: ...ath mouthpiece Turn on the monitor by pressing the power button once Press the breath test icon on screen Inhale and hold breath for the pre set 15 second countdown as shown on screen If unable to hold breath for full 15 seconds the timer can be adjusted in the settings ...

Страница 9: ...8 Press the home button at any time to cancel the breath test A beep will sound during the last three seconds of the countdown ...

Страница 10: ...9 Blow slowly into mouthpiece aiming to empty lungs completely The COHb and equivalent ppm levels will rise and hold on screen ...

Страница 11: ...reen press the home icon Results save automatically in the breath test log however there is the option to tag a result with a place patient s name or ID To tag a result press the patient profile icon and enter the place ID patient s name Press the save button Remove the D piece between tests to purge sensor with fresh air The unit will also power off after 8 hours of inactivity to save power The d...

Страница 12: ...hs per minute If face mask testing is used outside of these specifications this may result in decreased accuracy of readings Attach a new face mask sampling system in conjunction with the D piece Turn on the monitor by pressing the power button once Press the face mask breath test option Inhale and exhale into the face mask the device will take the reading in real time ...

Страница 13: ...be shown onscreen When the test is finished the face mask breath test music home and save icons will appear at the bottom of the screen The alarm may be muted by pressing the mute button To repeat breath test press the face mask breath test icon and repeat steps To return to the home screen press the home icon ...

Страница 14: ... patient profile icon and enter the place ID patient s name Press the save button Remove the face mask sampling system between tests to purge sensor with fresh air To switch off press and hold the power button for 3 seconds The unit will also power off after 8 hours of inactivity to save power The display dims after 5 minutes and turns off after 15 minutes ...

Страница 15: ... the device will start to sample immediately and the real time reading will be shown on the home screen at all times updating every second When a CO threshold is breached the monitor will log this event and continue to log the live reading every minute The logging will continue for 8 hours or until the monitor is switched off Access the log by pressing the history icon ...

Страница 16: ...sed to be triggered at higher levels When an alarm is triggered the device will automatically start to log in the history each minute for 8 hours or until the monitor is switched off so that incidents can be pinpointed to a time and date Breath test pre set thresholds are as follows Colour Description Reading COHb ppm Blue Normal non smoker reading COHb 0 2 00ppm 0 9 Red Abnormal CO level on breat...

Страница 17: ...16 Adjusting test thresholds Turn on the monitor by pressing the power button once Press the settings icon Press the traffic light icon ...

Страница 18: ...be adjusted Drag the threshold indicators up or down to the desired concentration the ppm values for breath testing will adjust automatically with the COHb Pressing the save button will save the changes pressing the back arrow will abort the changes and return to the previous screen ...

Страница 19: ...ngs Enabling ppm readings The ToxCO is programmed to only show the COHB when a breath test is taken however it is possible to also display the reading in ppm To enable the ppm display go to the settings Press the crossed out ppm icon ...

Страница 20: ...19 The breath test will look like this once the ppm readings have been enabled Disabling ppm readings To disable the ppm display go to the settings ...

Страница 21: ...20 Press the ppm icon The breath test will look like this once the ppm readings have been disabled ...

Страница 22: ...story every breath test but also ambient readings when an alarm threshold is triggered for up to 500 readings for 8 hours or until the monitor is switched off To access the history press the history icon Select either the breath test icon or the ambient icon ...

Страница 23: ...22 Changing date time To change the date time press the settings icon Press the date time icon ...

Страница 24: ...so the option to select between am and pm Dates and times are then adjusted by selecting the number to change and pressing the up or down arrows to decrease increase Press to save settings or to abort changes and return the previous screen Changing breath hold time To change the breath hold time press the settings icon ...

Страница 25: ... icon Changing the breath hold time is accomplished by pressing the up or down arrow to decrease increase the time in seconds Press the save icon to save setting or the back arrow to abort changes and return to the previous screen ...

Страница 26: ...ort humidity 0 95 Sensor operating life 2 years Sensor sensitivity 1ppm Sensor drift 5 per annum Dimensions Approx 37 x 77 x 140 mm Weight Approx 215g including batteries Materials Case polycarbonate ABS blend with SteriTouch anti microbial additive D piece polypropylene SteriBreath polypropylene OneBreath polypropylene H2 cross interference 6 Safety information and device symbols Degree of protec...

Страница 27: ...ironment specified below The customer or the user of the ToxCO should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic Discharge ESD IEC 61000 4 2 8kV contact 15kV air 8kV contact 15kV air Floor should be wood concrete or ceramic floor tile If floors are covered with synthetic material the relative ...

Страница 28: ...V m 870 MHz 28 V m 930 MHz 28 V m 1720 MHz 28 V m 1845 MHz 28 V m 1970 MHz 28 V m 2450 MHz 28 V m 5240 MHz 9 V m 5500 MHz 9 V m 5785 MHz 9 V m Portable and mobile RF communications equipment should be used no closer to the ToxCO than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter Interference may occur in the vicinity of equipment m...

Страница 29: ...th Countdown timer Exhale ppm reading COHb reading Ambient CO reading Home Change D piece Change CO test thresholds Save Change breath hold time History Next step Previous step Increase Decrease Selected Unselected ...

Страница 30: ...temperature too cold to calibrate Countdown to sensor change Change sensor Home screen when the sensor change is overdue Calibrate device reminder Calibration overdue Start calibration Attach flow meter to gas canister Attach calibration adaptor to D piece Attach D piece to monitor and turn on gas flow ...

Страница 31: ...vice training to appropriately qualified persons 5 Holding the reset button down for 30 seconds will perform a 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 6 Do not use the ToxCO in an oxygen rich atmosphere 7 It is recommended that...

Страница 32: ...symbol will be shown Change sensor if trained to do so by an approved Bedfont engineer or send to Bedfont or the local distributor 14 Additional technical information can be made available on request please contact Bedfont the local distributor Cleaning 1 The ToxCO is moulded with SteriTouch technology for optimum infection control and has proven bacterial protection efficacy However Bedfont recom...

Страница 33: ...nt recommend it is to be used It is recommended that the ToxCO is calibrated every 6 months however a calibration MUST be performed within 12 months using 50ppm CO calibration gas Please refer to the calibration procedure for more information Turn on the monitor by pressing the power button once Press the settings icon Press the cylinder icon once to proceed ...

Страница 34: ...r must be zeroed this will happen automatically Do not connect the gas at this stage If it is too cold to calibrate 17 C a blue thermometer will be shown onscreen Move the ToxCO to a warmer area and try again later ...

Страница 35: ... and try again later Ensure the fine control valve is in the off position 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 Once this has been successfully carried out the first step of the calibration process will be shown onscreen ...

Страница 36: ...litre per minute Allow the gas to flow through the instrument for the duration of the test again monitoring the rate of flow A successful calibration will be indicated by the tick icon press the home icon to return to the home screen ...

Страница 37: ...rted the correct way around matching the symbols moulded into the plastic The sensor has drifted out of specification The ToxCO is calibrated before leaving Bedfont However Bedfont recommends if the instrument could be reading incorrectly try the test again with another device if available to get a comparison Alternatively check the functionality using Bedfont check gas or send it back to Bedfont ...

Страница 38: ...onnecting to the PC Place one end of the connection lead into the USB socket on the top of the ToxCO Connect the other end to the USB port on the PC Before starting the software ensure that the ToxCO is connected to the PC and switched on Double click the ToxCOdata icon on the PC to start the program Refer to the supplied documentation for how to operate ToxCOdata ...

Страница 39: ...ay incur costs 3 Bedfont advises that a courier service is used when returning monitors This enables goods to be insured for loss or damage in transit When the goods are received an email stating so will be sent 4 If the device has been returned for repair it will then be examined and an engineer s report and quotation for the repair will be sent which will also include an authorisation form Compl...

Страница 40: ...tor cleansing wipes Free from alcohol to ensure continued performance of the monitor Products containing alcohol cannot be used on the ToxCO Warranty Bedfont Scientific Limited warrants the ToxCO excluding batteries to be free of defects in materials and workmanship for a period of two years from the date of shipment subject to service and maintenance requirements Bedfont s sole obligation under t...

Страница 41: ...40 Appendix Breath test face mask test interpretation chart10 12 Acute Exposure Guideline Levels AEGL s 13 ...

Страница 42: ...vailable at https www ncbi nlm nih gov pubmed 10713010 Accessed 27 Oct 2016 8 Rapid estimation of carboxyhemoglobin level in fire fighters Stewart R 1976 Rapid estimation of carboxyhemoglobin level in fire fighters JAMA The journal of the American medical association 235 4 pp 390 3929 Weaver LK e 2016 9 Kent Olson C 2008 Carbon monoxide poisoning acute BMJ Clinical Evidence online 2008 p Available...

Страница 43: ...42 Responsible Manufacturer and Contacts Bedfont Scientific Ltd Station Yard Station Road Harrietsham Maidstone Kent ME17 1JA United Kingdom www toxco com ask bedfont com 0044 1622 851122 ...

Страница 44: ... without prior notice Registered in England and Wales Registered No 1289798 Bedfont Scientific Ltd Station Road Harrietsham Maidstone Kent ME17 1JA England Tel 44 0 1622 851122 Fax 44 0 1622 854860 Email ask bedfont com Web www bedfont com Bedfont GmbH Mitterbachweg 18 5081 Anif Austria Tel 43 662 635050 Fax 43 662 635050 50 Email bedfont gmbh bedfont com Rx Only ...

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