Bedfont Smokerlyzer Series User manual

Smokerlyzer®Range
For use with piCOTM, piCObabyTM and Micro+TM
User manual
0086
Our family, innovang health, for yours.

! ! !
! ! 1!
!
Our$family,$innovating$health,$for$yours.$
!
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!.............................................................................................................!10!
Cleaning!............................................................................................................................................!11!
Routine!maintenance!.......................................................................................................................!11!
Troubleshooting!...............................................................................................................................!11!
COdata+™!software!–!connecting!to!the!PC!.....................................................................................!13!
Returns!procedure!...........................................................................................................................!13!
Spares!...............................................................................................................................................!14!
Warranty!..........................................................................................................................................!14!
References!........................................................................................................................................!14!
!
!
! !

! ! !
! ! 2!
!
Our$family,$innovating$health,$for$yours.$
Intended!use!
The!piCO™,!piCObaby™!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!gas1.!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!implications2.!
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!hours3.!!
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!bloodstream4.!!
The!piCO™!Smokerlyzer®!displays!both!CO!ppm!and!%COHb,!the!piCObaby™!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,! 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!

! ! !
! ! 3!
!
Our$family,$innovating$health,$for$yours.$
8. The!ppm!and!equivalent!%COHb!and/or!%FCOHb!levels!will!rise!and!hold!onscreen.!
9. On!the!piCO™!and!piCObaby™,!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.!
!
!

! ! !
! ! 4!
!
Our$family,$innovating$health,$for$yours.$
Traffic!light!pre-set!cut-off!levels!
Traffic!light!colour!
Description!
Reading!(ppm)!
piCO™!&!Micro+™!
piCObaby™!
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!
!! !
piCO™!
piCObaby™!
Micro+™!
Concentration!range!
0-150ppm!
0-150ppm!
0-500ppm!
Display!
Full!colour!touchscreen!
Detection!principle!
Electrochemical!sensor!
Repeatability!!
<±5%!
Accuracy!!
2ppm/5%*!
Power!
3!x!AA!(LR6!or!equivalent)!–!up!to!1000!minutes!
1!x!CR2032!Lithium!coin!cell!
T90!response!time!
<30!seconds!
Operating!temperature!
15-40°C!
Storage/transport!temperature!
0-50°C!
Operating/storage/transport!pressure!
Atmospheric!±10%!
Operating!humidity!
15-90%!RH!(non-condensing)!
Storage/transport!humidity!
0-95%!RH!(non-condensing)!
Sensor!operating!life!
5!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!
SteriTouch®!anti-microbial!additive!
D-piece™:!polypropylene!
SteriBreath™:!polypropylene!
H2!cross!interference!!
≤6%!
*whichever!is!greater!
!
!
!
!

! ! !
! ! 5!
!
Our$family,$innovating$health,$for$yours.$
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!!
!
Direct!current!
!
CE!mark!!
!
Type!BF!applied!part!
!
Dispose!of!according!to!WEEE!
!
Serial!number!
!
Manufacture!by!and!date!
!
Bedfont®!logo!
!
!
!
!
!
!
!
!
!
!
!
!
!

! ! !
! ! 6!
!
Our$family,$innovating$health,$for$yours.$
Environment!
The!piCO™,!piCObaby™!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!
EN55011:2007!
30MHz!to!1GHz!
Met!or!exceeded!
!
Radiated!Immunity!
EN61000-4-3:2006!+!
A1:2008!+!IS1!2009!+!
A2:2010!
10V/m!(1kHz!80%)!80MHz!–!
2.7GHz!
385!MHz!27!V/m!PM!18!Hz!
450!MHz!28!V/m!FM!1!kHz!sine!
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!
2450!MHz!28!V/m!PM!217!Hz!
5240!MHz!9!V/m!PM!217!Hz!
5500!MHz!9!V/m!PM!217!Hz!
5785!MHz!9!V/m!PM!217!Hz!
Met!or!exceeded!
Interference!may!occur!in!
the!vicinity!of!equipment!
marked!with!the!following!
symbol:!!
!
!
Power!Frequency!Magnetic!
Immunity!
EN61000-4-8:2010!
30!A/m!magnetically!sensitive!
equipment!
Met!or!exceeded!
!
ESD!
EN61000-4-2:1995+A1+A2!
8kV!contact!2,!4,8,15kV!air!
Met!or!exceeded!
!
!
!
!
!
!
!
!
!

! ! !
! ! 7!
!
Our$family,$innovating$health,$for$yours.$
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!
!
!
!
!
!
!
!
!
!
!
!
!
!
!

! ! !
! ! 8!
!
Our$family,$innovating$health,$for$yours.$
Display!and!device!symbols!
Description!
piCO™!
piCObaby™!
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!
!
!

! ! !
! ! 9!
!
Our$family,$innovating$health,$for$yours.$
Description!
piCO™!
piCObaby™!
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!
!
!
!