Bedfont ToxCO User manual

User manual
To x CO®
Helping to determine levels of CO poisoning.

1
Important Information/Reminders
NOTE: Only technical data and no patient data is collected by Bedfont®.
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.
CAUTION: Ensure the monitor is used within the stated operating temperature and humidity ranges.
Operating temperature is 15-35oC. Operating humidity is 25-80% RH (non-condensing).
CAUTION: Portable and mobile RF communications equipment can affect the ToxCO® monitor.
NOTE: When selecting an accessory for the ToxCO® monitor, please be advised that an accessory not
recommended by Bedfont® may result in loss of performance and damage to your ToxCO® device.
The product warranty does not cover product failure or damage resulting from use with non-
approved accessories.
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 .........................................................................................................................................4
Intended Use....................................................................................................................................... 4
Contraindications................................................................................................................................4
Instrument Layout............................................................................................................................... 5
User Interface ..................................................................................................................................... 6
Taking a breath test ............................................................................................................................7
Taking a face mask test..................................................................................................................... 11
Ambient monitoring..........................................................................................................................14
CO thresholds.................................................................................................................................... 15
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
References ........................................................................................................................................41
Responsible Manufacturer and Contacts..........................................................................................42

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Introduction
Carbon monoxide is a toxic, odourless, colourless, tasteless gas1. It is formed from incomplete
combustion of organic material at high temperatures with an insufficient oxygen supply3. When
inhaled, CO competes successfully with oxygen in the bloodstream to form carboxyhaemoglobin
(COHb). This starves the body tissues of the oxygen vital for repair, regeneration and general living.
CO can remain in the bloodstream for up to 24 hours, depending on a range of factors including
physical activity, gender and inhalation intensity9. The half-life is about 5 hours with no treatment
(normal environmental conditions), 1.5 hours if 100% oxygen is given and 0.58 hours if hyperbaric
oxygenation at 100% oxygen is given8.
Breath carbon monoxide is measured in parts per million (ppm) and blood carboxyhaemoglobin in
percentages (%COHb). The two measurements are compatible and convertible, CO relating to
lung/breath and COHb to blood gas as demonstrated by the conversion graph in the appendix on
page 147. The monitor displays %COHb, but can also display in ppm if selected in the settings. CO
ppm readings indicate the 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
modes allow the user to test a patient independent of their consciousness, whilst the ambient
sampling mode helps to safeguard the user by alerting them if they are entering areas with high
levels of CO.
A colour touchscreen ensures ease of operation, and all readings are automatically logged.
Additionally, all breath test readings can be tagged with a name, place or patient ID for quick
reference at a later date and time.
The ToxCO® not only helps to reduce unnecessary hospital admissions through instant screening but
also helps to save the lives of patients and staff, one breath at a time.
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.

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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.

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
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)

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

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Taking a breath test
Attach a breath sampling D-piece™ and SteriBreath™
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.

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.

9
Blow slowly into mouthpiece, aiming to empty lungs
completely.
The %COHb and equivalent ppm levels will rise and hold on-
screen.