Gastrolyzer Gastro CH4ECK Manuel utilisateur
GastroCH4ECKTM
Gastrolyzer®
Scienc contribuons to health.
User manual
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Contents'
Definitions!.................................................................................................................................................!2!
Intended!Use!.............................................................................................................................................!2!
Introduction!..............................................................................................................................................!3!
Safety!Notes!..............................................................................................................................................!3!
Contraindications!......................................................................................................................................!3!
Safety!During!installation!and/or!Maintenance!........................................................................................!4!
Electrical!Safety!.........................................................................................................................................!4!
Safety!against!Risk!of!Fire!..........................................................................................................................!4!
Mechanical!Safety!.....................................................................................................................................!4!
Environment!..............................................................................................................................................!5!
Safety!Information!and!Device!Symbols!...................................................................................................!6!
Monitor!Installation!..................................................................................................................................!7!
Monitor!Set-up!..........................................................................................................................................!7!
Temperature!Requirements!and!Device!Warm-up!...................................................................................!8!
Performing!a!breath!test!...........................................................................................................................!8!
Breath!bag!sample!collection!....................................................................................................................!9!
Analysing!a!breath!bag!test!.....................................................................................................................!10!
Instrument!Layout!...................................................................................................................................!11!
Standard!Pack!Content!............................................................................................................................!11!
Technical!Specification!............................................................................................................................!12!
Display!Symbols!.......................................................................................................................................!13!
Warnings!and!Maintenance!....................................................................................................................!16!
Cleaning!...................................................................................................................................................!17!
Changing!date!and!time!..........................................................................................................................!17!
Routine!Maintenance!..............................................................................................................................!17!
Calibration!...............................................................................................................................................!17!
GastroCHART™!Software!–!Connecting!to!the!PC!...................................................................................!18!
Returns!Procedure!..................................................................................................................................!19!
Warranty!.................................................................................................................................................!19!
Testing!Protocol!Thresholds!....................................................................................................................!20!
References!...............................................................................................................................................!20!
Spares!......................................................................................................................................................!21!
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Definitions'
CAUTION'indicates!a!potentially!hazardous!situation,!which,!if!not!avoided,!may!result!in!minor!or!
moderate!injury.!It!may!be!used!to!alert!against!unsafe!practices.!It!may!also!be!used!to!indicate!the!
possibility!of!erroneous!data!that!could!result!in!an!incorrect!diagnosis!(does!not!apply!to!all!
products).!!
IMPORTANT!is!used!for!comments!that!add!value!to!the!step!or!procedure!being!performed.!
Following!the!advice!in!the!Important!adds!benefit!to!the!performance!of!a!piece!of!equipment!or!to!
a!process.!
NOTE!is!used!to!call!attention!to!notable!information!that!should!be!followed!during!installation,!
use,!or!servicing!of!this!equipment!
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Intended'Use'
The!GastroCH₄ECK™!Gastrolyzer®!is!a!portable!desktop!monitor!which!measures!Hydrogen!(H2),!
Methane!(CH4)!and!Oxygen!(O2)!levels!in!expired!breath!samples!in!response!to!appropriate!
substrates.!It!is!intended!to!be!for!multi-patient!use!on!children!and!adults!and!used!by!healthcare!
professionals!primarily!in!a!hospital,!or!physician’s!surgery.!
The!expired!breath!can!be!delivered!direct!to!the!monitor!for!immediate!analysis!via!a!mouthpiece!
or!a!sample!can!be!taken!remotely!via!a!breath-bag!for!subsequent!analysis.!
The!GastroCH4ECK™!Gastrolyzer®!will!be!used!by!a!single!patient!at!a!time,!but!will!interface!with!a!
PC!to!allow!a!multi-patient!sampling!protocol!to!be!performed.!
The!GastroCH4ECK™!Gastrolyzer®!can!be!used!as!an!aide!to!diagnose!the!following!disorders:!
•Carbohydrate!Breakdown!Deficiency!
•Carbohydrate!Malabsorption!
•Lactose!Intolerance!
•Bacterial!Overgrowth!
•Determination!of!time!of!passage!through!gut!
Specific!diagnosis!is!not!possible!with!this!device;!further!specific!testing!would!need!to!be!carried!
out!to!diagnose!a!patient’s!condition!!
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Introduction'
H2!and!CH4!are!generated!in!the!intestinal!lumen!by!bacterial!action!on!carbohydrates!in!the!small!or!
large!intestine.!Once!the!resultant!H2!and!CH4!is!diffused!into!the!bloodstream!it!is!transported!to!
the!alveoli!and!then!can!be!detected!in!expiratory!air.!Levitt1!demonstrated!the!correlation!between!
intestinal!lumen!H2!and!CH4!production!and!H2!and!CH4!excretion!in!expiratory!air.!Accurate!
measurement!of!H2!and!CH4!in!parts!per!million!(ppm)!in!expiratory!air!reveals!intolerance!and/or!
malabsorption!of!carbohydrates;!or!bacterial!overgrowth.!
The!GastroCH4ECK™!Gastrolyzer®!also!measures!O2!levels!in!the!breath!sample!in!order!to!correct!for!
any!tests!that!do!not!achieve!an!end-tidal!breath!sample.!The!end-tidal!breath!sample!is!that!last!
portion!of!expired!air!and!contains!the!most!accurate!levels!of!H2!and!CH4.!End-tidal!breath!contains!
approx.!14-16%!O2!and!therefore!corrections!to!the!final!result!can!be!made!if!required!by!applying!a!
correction!factor!if!more!than!14%!O2!is!recorded!in!the!sample.!!
Operation!of!the!monitor!is!straightforward.!A!sampling!system!enables!end-expired!breath!to!be!
sampled!easily!and!hygienically,!using!single-use!disposable!mouthpieces!and!single-use!disposable!
face!masks.!!
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Safety'Notes''
To!avoid!electric!shock,!this!equipment!must!be!connected!to!a!mains!supply!with!protective!earth.!!
The!operator!should!not!touch!the!patient!whilst!in!contact!with!either!the!computer!or!the!USB!
connector!parts.!!
The!GastroCH₄ECK™!Gastrolyzer®!should!only!be!connected!to!a!computer!that!is!manufactured!in!
accordance!with!EN!60950!–!Safety!of!information!technology!equipment.!!
Please!do!not!attempt!to!modify!the!equipment!in!any!way!or!use!accessories!not!specified!for!use!
by!the!manufacturer.!Any!attempt!to!do!so!will!invalidate!the!warranty!and!may!affect!the!safety!of!
the!device.!!
Any!modification!to!this!equipment!during!the!actual!service!life!requires!evaluation!to!the!
requirement!of!EN!60601-1!
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Contraindications''
If!exhaling!gently!to!produce!a!breath!sample!is!physically!demanding!then!it!may!cause!
contraindications!in!patients!who!have!had!a!recent!myocardial!infarction.!Also!extensive!exhalation!
might!lead!to!syncope.!
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Safety'During'installation'and/or'Maintenance''
This!GastroCH₄ECK™!Gastrolyzer®!can!be!installed!by!a!trained!user!as!long!as!the!instruction!manual!
has!been!read.!This!GastroCH₄ECK™!Gastrolyzer®!weighs!6kg.!!
Do!not!open!the!GastroCH₄ECK™!Gastrolyzer®.!This!could!result!in!a!void!in!warranty.!Servicing!
should!only!be!carried!out!by!a!Bedfont!trained!representative.!
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Electrical'Safety''
To!reduce!the!risk!of!electrical!shock,!this!equipment!uses!a!three-wire!electrical!cord!and!plug!to!
connect!the!GastroCH₄ECK™!Gastrolyzer®!to!earth-ground.!To!preserve!this!safety!feature:!!
Make!sure!that!the!matching!wall!outlet!receptacle!is!properly!wired!and!earth-grounded.!Check!
that!the!line!voltage!agrees!with!the!voltage!listed!on!the!rear!label!affixed!to!the!GastroCH₄ECK™!
Gastrolyzer®.!Do!not!install!the!GastroCH₄ECK!Gastrolyzer®!on!a!ground!fault-protected!power!
source.!!
Do!not!place!containers!holding!liquid!on!or!near!the!GastroCH₄ECK.!If!they!spill,!liquid!may!enter!
the!GastroCH₄ECK!Gastrolyzer®!and!damage!electrical!or!mechanical!components.!
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Safety'against'Risk'of'Fire''
Fuses!protect!certain!electrical!circuits!within!this!GastroCH4ECK™!Gastrolyzer®!against!overcurrent!
conditions.!For!continued!protection!against!the!risk!of!fire,!replace!only!with!the!same!type!and!
rating!specified.!!
This!GastroCH4ECK™!Gastrolyzer®!is!not!designed!for!use!with!materials!capable!of!developing!
flammable!or!explosive!vapours.!Do!not!use/handle/store!such!materials!(such!as!chloroform!or!
ethyl!alcohol)!on!or!within!the!required!30-cm!(1-ft)!area!surrounding!the!GastroCH4ECK™!
Gastrolyzer®.!!
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Mechanical'Safety''
For!safe!operation!of!the!equipment,!observe!the!following:!!
•Use!only!accessories!designed!for!use!in!this!GastroCH4ECK™!Gastrolyzer®.!!
•Do!not!lift!or!move!the!GastroCH4ECK™!Gastrolyzer®!while!it!is!running.!This!could!damage!
the!methane!bench.!!!
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Environment''
The!GastroCH4ECK™!complies!with!the!directive!EN!60601-1-2!electromagnetic!compatibility!but!can!
be!affected!by!cellular!phones!and!by!electromagnetic!interference!exceeding!the!levels!specified!in!
EN!50082:1!
Guidance!and!manufacturer’s!declaration:!Electromagnetic!Immunity!(IEC!60601-1-2)!
The!GastroCH4ECK™!is!intended!for!the!use!in!the!electromagnetic!environment!specified!below.!The!
customer!or!the!user!of!the!GastroCH4ECK™!should!assure!that!it!is!used!in!such!an!environment.!
Immunity!test!!
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IEC!60601!Test!level!!
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Compliance!level!!
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Electromagnetic!environment!–!
guidance!!
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Conducted!RF!IEC!
61000-4-6!!
Radiated!RF!IEC!
61000-4-3!!
3!V!rms!150!kHz!~!
80MHz!outside!ISM!
bands*!!
10!V!rms!150!kHz!~!
80MHz!in!ISM!
bands*!!
10!V!rms!80!kHz!~!
2.5!GHz!!
3!V!rms!!
3!V/m!!
80MHz!to!2.5GHz!!
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Portable!and!mobile!RF!
communications!equipment!should!
be!used!no!closer!to!any!part!of!the!
GastroCH4ECK!including!cables,!
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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Note!1:!At!80!MHz!and!800!MHz,!the!higher!frequency!range!applies.!!
Note!2:!These!guidelines!may!not!apply!in!all!situations.!Electromagnetic!propagation!is!affected!by!
absorption!and!reflection!from!structures,!objects,!and!people.!
The!ISM!(industrial,!scientific,!and!medical)!bands!between!150!kHz!and!80!MHz!are!6.765!MHz!to!
6.795!MHz;!13.553!MHz!to!13.567!MHz;!26.957!MHz!to!27.283!MHz;!and!40.66!MHz!to!40.70!MHz.!!
The!compliance!levels!in!the!ISM!frequency!bands!between!150!kHz!and!80!MHz!and!in!the!
frequency!range!80!MHz!to!2.5!GHz!are!intended!to!decrease!the!likelihood!that!mobile/portable!
communications!equipment!could!cause!interference!if!it!is!inadvertently!brought!into!patient!areas.!
For!this!reason,!an!additional!factor!of!10/3!is!used!in!calculating!the!recommended!separation!
distance!for!transmitters!in!these!frequency!ranges.!!
Field!strengths!from!fixed!transmitters,!such!as!base!stations!for!radio!(cellular/cordless)!telephones!
and!land!mobile!radios,!amateur!radio,!AM!and!FM!radio!broadcast!and!TV!broadcast!cannot!be!
predicted!theoretically!with!accuracy.!To!assess!the!electromagnetic!environment!due!to!fixed!RF!
transmitters,!an!electromagnetic!site!survey!should!be!considered.!If!the!measured!field!strength!in!
the!location!in!which!the!GastroCH4ECK™!!is!used!exceeds!the!applicable!RF!compliance!level!above,!
the!GastroCH4ECK™!should!be!observed!to!verify!normal!operation.!If!abnormal!performance!is!
observed,!additional!measures!may!be!necessary,!such!as!reorienting!or!relocating!the!
GastroCH4ECK™.!!
Over!the!frequency!ranges!150!kHz!to!80!MHz!field!strength!should!be!less!than!3!V/m.!
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CAUTION''If!the!GastroCH₄ECK!Gastrolyzer®!is!used!in!a!manner!other!than!that!specified!in!this!
manual,!the!safety!and!performance!of!this!equipment!could!be!impaired.!Further,!the!use!of!any!
equipment!other!than!that!recommended!by!Bedfont!has!not!been!evaluated!for!safety.!Use!of!any!
equipment!not!specifically!recommended!in!this!manual!is!the!sole!responsibility!of!the!user.!'
CAUTION''Degree!of!safety!of!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.'
CAUTION'Do!not!place!the!GastroCH₄ECK!Gastrolyzer®!near!areas!containing!flammable!reagents!or!
combustible!fluids.!Vapours!from!these!materials!could!enter!the!GastroCH₄ECK!Gastrolyzer®!air!
system!and!be!ignited.!'
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Safety'Information'and'Device'Symbols''
Degree'of'protection'against'electric'shock'
Type!BF!applied!part!
Type'of'protection'against'electric'shock'
Class!I!equipment;!(earthed)!
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.!
Caution'–'please'refer'to'the'warnings'and'safety'
notices'in'this'manual''
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Refer'to'Manual''
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Alternating'Current'
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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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Manufacture'by'and'Date'
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Bedfont'Logo'
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Monitor'Installation'
Maintain!a!30-cm!(1-ft)!clearance!envelope!above!the!GastroCH4ECK™!Gastrolyzer®!while!it!is!
running.!The!equipment!should!not!be!positioned!such!that!it!is!difficult!to!operate!the!
disconnection!device!(Mains!Plug).!!
If!it!is!necessary!to!move!the!GastroCH4ECK™!Gastrolyzer®,!maintain!the!following!conditions:!!
1. Select!a!location!away!from!heat-producing!laboratory!equipment,!with!sufficient!ventilation!to!
allow!heat!dissipation.!!
2. Position!the!GastroCH4ECK™!Gastrolyzer®!on!a!level!surface,!such!as!a!sturdy!table!or!laboratory!
bench!that!can!support!the!weight!of!the!GastroCH4ECK™!Gastrolyzer®!6!kg!and!resist!vibration.!
3. Place!the!GastroCH4ECK™!Gastrolyzer®!at!least!5!cm!(2!in.)!from!the!front!edge!of!the!surface.!!
4. In!addition!to!space!for!the!GastroCH4ECK™!Gastrolyzer®,!allow!15.2!cm!(6-in.)!clearances!at!the!
sides!and!back!to!ensure!sufficient!air!circulation.!The!GastroCH4ECK™!Gastrolyzer®!must!have!
adequate!air!ventilation!to!ensure!compliance!to!local!requirements!for!vapours!produced!
during!operation.!!
5. Relative!humidity!should!not!exceed!75%!(non-condensing)!!
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Monitor'Set-up'
1. Connect!the!power!lead!to!the!GastroCH4ECK™!via!the!socket!on!the!rear!of!the!panel!and!
connect!to!the!electricity!supply:!
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2. Switch!the!monitor!on!using!the!on/off!switch!on!the!back!of!the!unit.!The!green!LED!should!
light!up.!The!GastroCH4ECK™!monitor!will!begin!a!purging!process,!the!full!warm!up!takes!30!
minutes,!see!‘Temperature!Requirements’,!and!a!countdown!timer!will!be!shown!onscreen!for!
the!duration!of!the!warm-up!as!shown:! .!
3. Connect!the!sampling!line!to!the!sample!line!dock!for!Breath!samples,!ensuring!the!connecter!
‘clicks’!fully!into!place.!
4. Push!moisture!filter!onto!bag!sampling!port!for!breath!bag!sampling.!!
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ON
OFF
100-240V~
50/60Hz
FUSE
T 300 mA
!0086
Bedfont Scientific Ltd
Station Road, Harrietsham,
Maidstone, Kent
ME17 1JA, UK
Tel: +44(0)1622 851122
Fax: +44(0)1622 854860
Email:[email protected]
Web: www.bedfont.com
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Temperature'Requirements'and'Device'Warm-up'
Temperature!should!not!exceed!those!stated!in!the!specifications!section!of!this!document.!The!
monitor!should!be!calibrated!at!the!same!temperature!at!which!it!would!be!used,!ideally!21°c!+3°c!
(69.8°F!+5.4°F).!!
The!unit!requires!a!warm!up!time!of!30!minutes!before!it!can!be!used.!The!warm!up!screen!can!be!
bypassed!after!2!minutes!30!seconds!from!the!power!being!turned!on,!this!bypass!should!only!be!
used!if!the!unit!is!accidently!switched!off!or!needs!to!be!moved.!The!bypass!must!only!be!done!
within!2!minutes!of!the!unit!being!switched!off,!as!using!the!device!without!the!correct!warm-up!
time!will!compromise!accuracy.!The!bypass!is!carried!out!by!pressing! !on!the!warm-up!screen.!
You!will!be!asked!to!confirm!this!decision!by!again!pressing! !on!the!next!screen;!this!will!take!
you!to!the!device!home!screen.!
NOTE'The!instrument!should!be!calibrated!prior!to!first!use,!after!transportation!and!every!4!weeks.'
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Performing'a'breath'test'
1. Once!warm-up!has!been!completed,!attach!the!sample!line!and!a!breath!sampling!mouthpiece.!!
2. Press! .!
3. A!timer! !will!be!shown!onscreen,!whilst!the!sensors!are!zeroing,!this!may!take!up!to!60!
seconds.!
4. Inhale!when!prompted!by!and!hold!breath!for!the!pre-set!15!second!countdown,!as!
shown!on!screen.!!
5. A!beep!will!sound!during!the!last!three!seconds!of!the!countdown .!!
6. Blow!slowly!into!mouthpiece!when!prompted!by! .!
7. An!indicator!on-screen!will!illustrate!how!hard!to!blow ;!keep!the!arrow!pointing!in!the!
green!section!of!this!indicator!throughout!the!test.!!
8. The!arrow!will!change!colour!as!the!O2!level!in!the!breath!sample!reduces!to!the!target!14%!at!
which!point!it!will!turn!green!and!the!test!will!stop.! !
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9. If!the!patient!feels!they!are!unable!to!exhale!for!any!longer!and!the!test!has!not!finished!they!
can!end!the!test!at!any!time!by!pressing! .!
10. The!final!results!will!be!shown!on!screen .!
11. Once!the!test!is!complete!the!final!O2!concentration!can!be!observed!by!pressing! ,!this!will!
show!the!O2!concentration!in!%!and!the!correction!factor!applied!to!the!reading,!if!it!was!
required.!A!visual!indicator!will!help!interpretation!of!the!result:!
a. !Good!test,!little!or!no!correction!factor!applied!
b. Satisfactory!test,!correction!factor!applied!
c. Poor!test,!high!correction!factor!applied!another!test!is!recommended!
12. Press! !to!return!to!the!results!screen.!
13. When!you!are!finished!press! !to!return!to!the!home!screen.!NOTE!this!will!lose!the!reading,!
please!ensure!you!have!downloaded!to!GastroCHART™!or!recorded!manually.!!
14. Remove!the!mouthpiece!and!sample!line!between!tests!to!purge!sensors!with!fresh!air!
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Breath'bag'sample'collection''
1. Remove!the!blue!plastic!plugs!from!each!end!of!the!breath!bag.!!
2. Place!two!bag!clamps!over!the!inlet!and!outlet!tubes!of!the!breath!bag.!!
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3. Insert!a!breath!bag!mouthpiece!into!the!bag!inlet!tube!of!the!breath!bag.!!
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4. Ensure!both!bag!clamps!are!disengaged/open,!allowing!air!to!pass!through!the!bag.!!
5. Exhale!gently!through!the!bag!at!a!steady!rate.!!
6. Continue!exhaling!until!you!feel!you!have!nearly!emptied!your!lungs.!This!clears!the!dead!air!in!
the!upper!airspace!of!the!lungs!in!order!to!achieve!a!good!end-tidal!sample.!!
7. As!soon!as!you!feel!your!lungs!are!nearly!empty,!and!end-tidal!breath!has!almost!been!reached,!
engage/close!the!clamp!at!the!outlet!of!the!bag.!! !
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