Bedfont ToxCO User manual

User manual
0086
To x CO®
Our family, innovang health, for yours.

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Saving'lives,'one'breath'at'a'time.'
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Contents!
Intended!use!.......................................................................................................................................!2!
Introduction!........................................................................................................................................!2!
Taking!a!breath!test!............................................................................................................................!2!
Taking!a!face!mask!test!......................................................................................................................!3!
Ambient!monitoring!...........................................................................................................................!4!
CO!thresholds!.....................................................................................................................................!4!
Adjusting!test!thresholds!....................................................................................................................!5!
Enabling/disabling!ppm!reading!.........................................................................................................!5!
Reviewing!history!...............................................................................................................................!6!
Changing!date!and!time!.....................................................................................................................!6!
Changing!breath-hold!time!................................................................................................................!6!
Technical!specification!.......................................................................................................................!7!
Safety!information!and!device!symbols!.............................................................................................!7!
Environment!.......................................................................................................................................!8!
Instrument!layout!...............................................................................................................................!9!
Display!and!device!symbols!................................................................................................................!9!
Warnings!and!maintenance!.............................................................................................................!12!
Cleaning!............................................................................................................................................!13!
Routine!maintenance!.......................................................................................................................!13!
Troubleshooting!...............................................................................................................................!13!
Calibration!procedure!......................................................................................................................!14!
ToxCOdata™!software!–!connecting!to!the!PC!.................................................................................!15!
Returns!procedure!...........................................................................................................................!15!
Spares!...............................................................................................................................................!16!
Warranty!..........................................................................................................................................!16!
Appendix!..........................................................................................................................................!17!
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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.!
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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!intensity10.!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!your!patients!and!your!staff,!one!breath!at!a!time.!
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Taking!a!breath!test!
1. Attach!a!breath!sampling!D-piece™!and!new!SteriBreath™!mouthpiece.!!!
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2. Turn!on!the!monitor!by!pressing!the!power!button!once.!

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3. Press!‘breath!test’!symbol!onscreen,! .!
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4. To!cancel!the!breath!test,!press .!
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5. Inhale!and!hold!breath!for!the!pre-set!15!second!countdown.!!
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6. A!beep!will!sound!during!the!last!three!seconds!of!the!countdown.!!
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7. Blow!slowly!into!the!mouthpiece,!aiming!to!empty!lungs!completely.!
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8. The!%COHb!and!equivalent!ppm!levels!will!rise!and!hold!on-screen.!
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9. The!alarm!may!be!muted!by!pressing! .!
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10. When!the!test!is!finished! ! ! !will!appear!at!the!bottom!of!the!screen.!
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11. To!repeat!breath!test,!press! !once!and!repeat!steps!5!-!10.!
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12. To!return!to!the!home!screen,!press! .!
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13. 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! !and! enter! the!
place/ID/patient’s!name!and!click!save! .!
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14. Remove!the!D-piece™!between!tests!to!purge!the!sensor!with!fresh!air.!
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15. 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).!
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Taking!a!face!mask!test!
NOTE:!The!face!mask!testing!protocol!has!been!developed!for!use!on!patients!aged!6!years!and!over,!
with!a!respiration!rate!of!between!12-20!breaths!per!minute.!If!face!mask!testing!is!used!outside!of!
these!specifications,!this!may!result!in!decreased!accuracy!of!readings.!
1. Attach!a!new!face!mask!sampling!system!in!conjunction!with!the!D-piece™.!!
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2. Turn!on!the!monitor!by!pressing!the!power!button!once.!!
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3. Press!‘face!mask’!symbol!onscreen,! .!
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4. The!patient!should!inhale!and!exhale!normally!into!the!face!mask;!the!device!will!take!the!
reading!in!real-time.!
5. The!alarm!may!be!muted!by!pressing! .!
6. Sampling!will!last!60!seconds!as!the!%COHb/ppm!levels!rise!and!then!hold!at!the!peak!level.!
The!result!will!be!shown!onscreen.!
7. When!the!test!is!finished ! ! !will!appear!at!the!bottom!of!the!screen.!
8. To!repeat!the!face!mask!test,!press! !and!repeat!steps!4-7.!
9. To!return!to!the!home!screen,!press! .!
10. 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! !and! enter! the!
place/ID/patient’s!name!and!click!save! .!
11. Remove! the! face!mask! sampling! system!and! D-piece™!between! tests! to! purge! the! sensor!
with!fresh!air.!!
12. 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.!!
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Ambient!monitoring!
The! ambient! air! can! be! tested! to! check! for! CO! in! the! environment! using! the! ToxCO®,! alerting!
users! to! high! CO! levels! in! the! atmosphere.! Once! switched! on! 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.!
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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.!!
You!can!access!the!log!by!clicking! .!
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CO!thresholds!!
Ambient!alarm!thresholds!are!preset!as!per!Acute!Exposure!Guideline!Levels!(AEGL’s)13:!
Colour!
ppm!
Audible!alert!
Green!
<100!
No!audible!alert!
Amber!
100-199!
1!Short!beep!every!2!seconds!
Red!
≥200!
3!Short!beeps!every!3!seconds!
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Both!thresholds!can!be!reduced!so!that!they!are!triggered!at!lower!levels!but!cannot!be!increased!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.!!
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Breath!test!pre-set!thresholds!are!as!follows:!
Colour!
Description!
Reading!(%COHb!&!ppm)!
Blue!
Normal!(non-smoker)!reading!
%COHb!≤!0-2.00!
ppm!=!0-9!
Red!
Abnormal!CO!level!on!breath!requiring!further!
investigation!
%COHb!>!2!
ppm!=!10+!
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This!threshold!for!colour!change!can!be!adjusted!up!or!down!to!suit!local!regulations.!
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Adjusting!test!thresholds!
1. !Turn!on!the!monitor!by!pressing!the!power!button!once.!
2. Press! .!
3. Press! .!
4. Press!or! depending!on!which!threshold!is!to!be!adjusted.!
5. Drag!the!threshold!indicators!up!or!down!to!the!desired!concentration;!
the! ppm! values! for!breath! testing! will! adjust! automatically! with! the!
%COHb.!
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6. Pressing! !will! save! the! changes;! pressing! !will! abort!the!
changes!and!return!to!the!previous!screen.!!
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Enabling/disabling!ppm!reading!
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! !and!
then!click!on!the!crossed!out!ppm!icon! .The!breath!test!will!look!like!this! !once!the!
ppm!readings!have!been!enabled.!
To!disable!the!ppm!display,!go!to!the!settings! !and!then!click!on!the!ppm!icon!! .!The!breath!
test!will!look!like!this! !once!the!ppm!readings!have!been!disabled.!
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Reviewing!history!!
The!ToxCO®!will!record/log!in!its!history!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! !and!then!either! for!the!breath!test!log!or! !for!the!ambient!
log.!
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Changing!date!and!time!!
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Press! !and!then! !to!access!the!date/time!menu.!You!can!then!select!either!d-m-y!or!m-d-y!
for!the!date!format!and!12h!or!24h!for!the!time!format.!With!the!12h!format,!there!is!also!the!option!
to!select!between!am!and!pm.!Dates!and!times!are!then!adjusted!by!selecting!the!number!you!wish!
to!change!and!pressing! or! !to!decrease/increase.!Press! !to!save!your!settings!or!
to!abort!changes!and!return!the!previous!screen.!
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Changing!breath-hold!time!
Press! !and!then! to!access!the!breath-hold!time!screen.!
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Changing! the! breath-hold! time! is! accomplished! by! pressing! or! !to! decrease/increase!the!
time!in!seconds.!Press! !to!save!your!settings!or! !to!abort!changes!and!return!the!previous!
screen.!
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Technical!specification!
Concentration!range!(CO)!
0-54%COHb/0-600ppm!
Display!
Full-colour!touchscreen!
Detection!principle!
Electrochemical!sensor!
Repeatability!
≤±5%!difference!on!consecutive!readings!
Accuracy!
≤±3ppm/10%!–!whichever!is!greater*!
Power!
3!x!AA!(LR6!or!equivalent)!–!up!to!1000!minutes!
1!x!CR2032!Lithium!coin!cell!
T90!response!time!!
<30!seconds!
Operating!temperature!
0-50°C!
Storage/transport!temperature!
0-50°C!
Operating/storage/transport!pressure!
Atmospheric!±10%!
Operating!humidity!
15-90%!non-condensing!
Storage/transport!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!
H2!cross!interference!
≤6%!
*Readings!of!>500ppm!at!temperatures!between!0-14°C!can!decrease!accuracy!to!≤±3ppm/15%.!
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!
flammable!anaesthetic!mixture!with!air,!oxygen!
or!nitrous!oxide!
Equipment!not!suitable!for!use!in!the!
presence!of!flammable!mixtures.!
Refer!to!manual!!
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Direct!current!
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CE!mark!!
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Type!BF!applied!part!
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Dispose!of!according!to!WEEE!
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Serial!number!
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Manufactured!by!and!date!
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Bedfont®!logo!
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Environment!
The!ToxCO®!complies!with!the!directive!EN60601-1-2:2015!4th!edition!electromagnetic!compatibility.!
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Electromagnetic!immunity:!
The!ToxCO®!complies!with!the!directive!EN60601-1-2!electromagnetic!compatibility!but!can!be!
affected!by!cellular!phones!and!by!electromagnetic!interference!exceeding!the!levels!specified!in!
EN55011:2007!Class!B.!
Guidance!and!manufacturer’s!declaration:!Electromagnetic!immunity!
The!ToxCO®!is!intended!for!use!in!the!electromagnetic!environment!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!humidity!
should!be!at!least!30%.!
Electrical!fast!
transient/burst!
IEC!61000-4-5!
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Surge!
IEC61000-4-5!
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Voltage!dips,!
short!
interruptions!
and!voltage!
variations!on!
power!supply.!
IEC!61000-4-11!
–!
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Power!
frequency!
(50/60Hz)!
Magnetic!field!
IEC!61000-4-8!
30!A/m!
30!A/m!
Power!frequency!
magnetic!fields!should!be!
at!levels!characteristic!of!
a!typical!location!
environment.!
Conducted!RF!
IEC!61000-4-6!
Radiated!RF!
IEC!61000-4-3!
10V/m!(1kHz!80%)!80MHz-2.7GHz!
10V/m!(1kHz!80%)!80MHz-2.7GHz!
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!
marked!with!the!following!
symbol:!
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385!MHz!
27!V/m!
385!MHz!
27!V/m!
450!MHz!
28!V/m!
450!MHz!
28!V/m!
710!MHz!
9!V/m!
710!MHz!
9!V/m!
745!MHz!
9!V/m!
745!MHz!
9!V/m!
780!MHz!
9!V/m!
780!MHz!
9!V/m!
810!MHz!
28!V/m!
810!MHz!
28!V/m!
870!MHz!
28!V/m!
870!MHz!
28!V/m!
930!MHz!
28!V/m!
930!MHz!
28!V/m!
1720!MHz!
28!V/m!
1720!MHz!
28!V/m!
1845!MHz!
28!V/m!
1845!MHz!
28!V/m!
1970!MHz!
28!V/m!
1970!MHz!
28!V/m!
2450!MHz!
28!V/m!
2450!MHz!
28!V/m!
5240!MHz!
9!V/m!
5240!MHz!
9!V/m!
5500!MHz!
9!V/m!
5500!MHz!
9!V/m!
5785!MHz!
9!V/m!
5785!MHz!
9!V/m!
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Instrument!layout!
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1. Display!
2. Power!button!
3. Breath!sampling!D-piece™!
4. D-piece™!hole!
5. Exhaust!port!for!breath!sample!
6. USB!connector!(for!use!with!ToxCOdataTM!
Software)!
7. Single-use!SteriBreath™!mouthpiece!
8. Battery!compartment!!
9. Battery!compartment!clip!
10. Reset!button!
11. Programming!switch!
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Display!and!device!symbols!
Description!
ToxCO®!symbol!
Battery!condition:!full!
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Battery!condition:!low!
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Battery!condition:!empty!
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Breath!test!!
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Face!mask!test!
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2!
6!
4!
5!
8!
9!
3!
7!
10!
11!