GastroCH4ECK
TM
Gastrolyzer
®
Scienc contribuons to health.
User manual
0086
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GastroCH4ECK
TM
Gastrolyzer®
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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GastroCH4ECK
TM
Gastrolyzer®
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Definitions'
CAUTION'indicates!a!potentially!haz ar d ou s !sit u at ion ,!which,!if!not!avoided,!ma y!r es u lt!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!u se d !fo r!c o m ments!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 !n o ta b le !inf or m a tio n !t ha t !sh o u ld !be !fo llo w e d !d u rin g !ins ta lla tio n ,!
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!respon se !to!ap pro pria te!
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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GastroCH4ECK
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Gastrolyzer®
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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 !re su lt an t !H2!and!CH4!is!diffused!into!the!bloo d s tre am!it!is!transported!to!
the!alveoli!and!then!can!be!detected!in!expira tory!a ir.!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!in t o lera n c e!a n d /o r!
malabsorption!of!carbohydrates;!or!bacterial!overgrowth.!
The!GastroCH4ECK™!Gastrolyzer®!also!measures!O2!levels!in!the!breath!sample!in!order!to!correct!fo r!
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!sam p le .!!
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!pro duce!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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GastroCH4ECK
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Gastrolyzer®
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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!represen tative .!
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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!lab el!affixe d!to!th e!G astro CH ₄EC K™!
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!n o t!us e/h and le/store!such!ma terials!(such!as!chloroform!or!
ethyl!alcohol)!on!or!within!the!required!30-cm!(1-ft)!area!surroun din g!th e!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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GastroCH4ECK
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Gastrolyzer®
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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!sepa ration !
distance!calculated!from!the!
equation!appropriate!to!the!
frequency!of!the!transmitter.!!
Interference!may!occ u r!in !t h e!
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!GH z!are !inten de d !to!de crea se!th e!likelih oo d!th at!m o bile/ po rtab le!
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!sho uld!b e!co nsid ered .!If!the!m ea sure d!field!stre ng th!in!
the!location!in!which!the!GastroCH4ECK™!!is!used!exceeds!the!ap p lic ab le !R F!c o mpliance!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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GastroCH4ECK
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CAUTION''If!the!GastroCH₄ECK!Gastrolyzer®!is!used!in!a!manner!other!than!that!sp e cifie d !in !th is !
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'Sym b o ls''
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'a ir,'oxyge n'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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GastroCH4ECK
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Gastrolyzer®
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Monitor'Installation'
Maintain!a!30-cm!(1-ft)!clearance!envelope!abo ve!th e! 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!con d i tio ns:!!
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!fo r !th e !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
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0086
Bedfont Scientific Ltd
Station Road, Harrietsham,
Maidstone, Kent
ME17 1JA, UK
Tel: +44(0)1622 851122
Fax: +44(0)1622 854860
Email:ask@bedfont.com
Web: www.bedfont.com
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GastroCH4ECK
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Gastrolyzer®
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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!bein g!turn ed !on ,!this!by pa ss!sh ou ld!o nly!b e!
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!ac cu ra c y.!T h e !by p a ss !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!a re !u n a b le !to !e xhale!for!any!longer!an d !th e !te st !h as !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 !resu lt:!
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.!N O TE!th is!will!lose!the !read ing,!
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!m o u t h p iec e !in to !t h e!b a g !in le t!tu b e !o f!t h e !b re at h !b a g. !!
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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!ord er !to !a ch ie ve !a !go o d !e nd-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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8. Whilst!still!maintaining!a!steady!flow,!fill!up!the!breath!bag!COMPLETELY!with!your!end!tidal!
breath,!ensuring!you!do!not!inhale!whilst!doing!this.!!
9. Engage!the!clamp!at!the!inlet!of!the!bag.!
!
10. Replace!the!blue!plastic!plugs!in!each!end!of!the!breath!bag!to!ensure!no!breath!is!lost!from!the!
sample.!!
Following(these(steps(should(ensure(that(a(valid(sample(has(been(collected.(
(
Analysing'a'breath'bag'test'
1. Once!warm-up!has!been!completed,!attach!the!breath!bag!moisture!filter!to!the!device.!
2. Press! to!start!the!bag!test!procedure.!!
3. A!timer! !will!be!shown!onscreen,!whilst!th e !se n s o r s!a r e !ze r o in g ,!th i s!may!take!up!to!60!
seconds.!
4. The!device!will!then!illustrate!to!attach!the!breath!bag.!Ensure!to!carefully!remove!the!blue!plug!
on!one!end!only,!attach!to!the!moisture!filter!and!then!open!the!clamp!on!that!end!only!to!
preserve!the!sample.!!
5. Press! !at!this!point!the!device!needs!no!further!intervention!until!a!reading!is!recorded.!
6. The!device!will!draw!the!breath!sample!for!analysis,!this!will!take!45!seconds,!indicated!on!the!
screen.!
7. The!final!results!will!be!shown!on!screen .!
8. 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 !resu lt:!
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!
9. Press! !to!return!to!the!results!screen.!
10. When!you!are!finished!press! !to!return!to!the!home!screen.!N O TE!th is!will!lose!the !read ing,!
please!ensure!you!have!downloaded!to!GastroCHART™!or!recorded!manually.!!
11. Remove!the!breath!bag!and!moisture!filter!between!tests!to!purge!sensors!with!fresh!air.!!
!
!
11!
!
!
GastroCH4ECK
TM
Gastrolyzer®
!
Instrument'Layout'
!
!
!
!
!
!
!
!
!
'
!
Standard'Pack'Content'
1. GastroCH4ECK™!Monitor!
2. Operating!Manual!
3. Mains!Cable!
4. GastroCHART!software!(available!from!
www.bedfont.com)!
5. USB!cable!
6. Direct!Sampling!line!
7. Moisture!Removal!Filter!
!
Accessories'
1. Breath!Bag!
2. Breath!Bag!Mouthpieces!
3. Patient!Direct!Breath!Mouthpieces!
4. Bag!Clamp!
5. Calibration!Kit!
a. Regulator!with!or!without!Flow!
Metre!
b. Calibration!Tubing!
c. Combination!Gas!Canister!
d. Calibration!adaptor!
GastroCH4ECK
TM
Gastrolyzer
®
Bag Sample connector
Sampling Line Dock
ON
OFF
100-240V~
50/60Hz
FUSE
T 300 mA
!
0086
DO NOT COVER
Outlet
Exhaust
Zero
Reference
USB
On/Off Switch
Cooling Fan
Zeroing
Mains Power Inlet
USB
Bedfont Scientific Ltd
Station Road, Harrietsham,
Maidstone, Kent
ME17 1JA, UK
Tel: +44(0)1622 851122
Fax: +44(0)1622 854860
Email:ask@bedfont.com
Web: www.bedfont.com
Side Stream
Exhaust
!
!
12!
!
!
GastroCH4ECK
TM
Gastrolyzer®
!
Technical'Specification'
!
GastroCH₄ECK™'Gastrolyzer®'
Concentration'Range''
CH4'
0-200!ppm!
H2'
0-200!ppm!!
O2'
14-23%!
Power'input''
230V/50Hz/100mA![115V/60Hz/220mA!
compatible]!
Warm-up'time'
30!minutes!
Calibration'Frequency''
Every!4!weeks!!
Display'
Full!colour!touchscreen!
Detection'Principle'
Electrochemical!sensor!(O2!&!H2)!
Infrared!(CH4)!
'
'
'
'
Accuracy''
'
CH4'
Resolution'
1!ppm!
Accuracy'
+/-!10%!of!reading!per!annum!
Repeatability'
<5%!difference!on!consecutive!readings!
'
H2'
Resolution'
1!ppm!
Accuracy'
+/-!10%!of!reading!per!annum!
Repeatability'
<5%!difference!on!consecutive!readings!
'
O2'
Resolution'
0.1%!
Accuracy'
+/-!10%!of!reading!per!annum!
Repeatability'
<5%!difference!on!consecutive!readings!
Carbon'Monoxide'Cross-sensitivity'(H2'only)'
<1%!
Temperature'Range'
Operating'
15-35°C!(59°-!95°F)!
Storage'
0-40°C!(32°-!104°F)!
Pressure'Range''
Operating'
900-1100mBar!
Storage'
800-1200mBar!
Humidity'Range'
Operating'
30-75%!non-condensing!
Storage'
15-90%!non-condensing!
'
Sensor'Operating'Life'
CH4'
5!years!
H2'
2!years!
O2'
2!years!
Dimensions'
Approx.!34!x!75!x!140!mm!
Weight'
Approx.!6kg!
Monitor'Construction'
Case:!Polycarbonate/ABS!blend!
SteriTouch!anti-microbial!additive!
D-Piece:!Polypropylene!
Classification'
Class!I!ME!Equipment:!(Externally!Powered)!!
Type!BF!Applied!Part!!
Method!of!Sterilization!(Not!suitable!for!
sterilization)!!
Not!suitable!for!use!in!an!oxygen!rich!
environment!!
Intended!for!contin u o u s!u s e!
Approx.'1'x'CR2032'Battery'Life'
175,000!hours!!
T90'Response'Time''
≤45!seconds!
!
!
!
13!
!
!
GastroCH4ECK
TM
Gastrolyzer®
!
Display'Symbols'
Description'
GastroCH₄ECK™'Gastrolyzer®'
Breath'Test''
!
Inhale'
!
Hold'Breath'
!
Countdown'(breath'hold)'
!
Exhale'
!
ppm'Reading''
!
O2'Reading''
!
Correction'Factor'
!
Check'Test'Quality'
!
Settings'
!
Home''
!
Exhalation'Speed'Gauge'
!
Good'test,'little'or'no'
correction'factor'applied'
!
Satisfactory'test,'correction'
factor'applied'
!
Poor'test,'high'correction'factor'
applied'another'test'is'
recommended'
!
!
!
14!
!
!
GastroCH4ECK
TM
Gastrolyzer®
Breath'Bag'Test'
!
Attach'Breath'Bag'to'Moisture'
Filter'
!
Bag'Sample'Countdown'
!
Next'Step'
!
Previous'Step'
!
Sensor'Change'Due'Soon'
!
Sensor'Change'Overdue'
!
Device'Calibration'Due'
!
Start'Calibration'Procedure'
!
Device'Zeroing'Sensors''
!
Check'Calibration'Gas'
Requirements''
!
Attach'Regulator'to'Gas'
Canister'
!
!
!
15!
!
!
GastroCH4ECK
TM
Gastrolyzer®
Attach'Calibration'Adaptor'to'
Device'and'Turn'on'Gas'Flow'
!
System'Processing'
!
Calibration'Successful'
!
Calibration'Failed'
!
Retry'Calibration/Zero'
!
Service'Area'(PIN'Protected)'
!
Sensor'Servicing''
!
Troubleshooting''
!
Diagnostics''
!
Calibration'Servicing''
!
Edit'Date/Time'
!
Day-Month-Year'
!
Month-Day-Year'
!
24'Hour'Format'
!
12'Hour'Format'
!
H2'Sensor''
!
O2'Sensor'
!
!
!
16!
!
!
GastroCH4ECK
TM
Gastrolyzer®
CH4'Sensor'
!
H2'Sensor'Zero'Failure'
!
O2'Sensor'Zero'Failure'
!
CH4'Sensor'Zero'Failure'
!
CH4'Sensor'Failure''
!
Sensor'Installation'Date'
!
Sensor'Renewal'Date'
!
Sensor'Renewal'Date'Overdue'
!
Save'Settings'
!
Firmware'Version'
!
Serial'Number'
!
!
Warnings'and'Maintenance'
1. Mouthpieces!should!be!replaced!after!every!patient.!!
2. Hands!should!be!washed!regularly!in!accordance!with!infection!control!practice.!!
3. Please!do!not!attempt!to!modify!the!equipment!in!any!way!or!use!accessories!not!specified!by!
the!manufacturer.!Any!attempt!to!do !so!w ill!invalidate!th e!w arra nty !and !m ay!co m p rom ise!th e!
safety!of!the!device.!!
4. Bedfont!will!make!available!upon!request!service!training!to!appropriately!qualified!persons.!
5. Pressing!and!confirming!a!calibration!reset!will!reset!the!calibration!to!factory!settings.!The!
device!will!then!require!calibration!before!it!can!be!used!again.!Only!after!a!calibration!has!been!
performed!will!the!new!settings!be!saved.!Aborting!the!calibration!reset!at!any!stage!will!revert!
the!calibration!back!to!the!previous!settings.!!
!
V2.23
!
!
17!
!
!
GastroCH4ECK
TM
Gastrolyzer®
Cleaning'
1. Bedfont!recommend!wiping!the!instrument!external!surfaces!with!a!product!specifically!
developed!for!this!purpose.!Bedfont!provides!instrument!cleaning!wipes.!The!device!or!
consumables!cannot!be!sterilised.!
2. NEVER!use!alcohol!or!cleaning!agents!containing!alcohol!or!other!organic!solvents!as!long!term!
exposure!to!these!vapours!will!damage!the!sensors!inside.!!
3. Under!no!circumstances!should!the!instrument!be!immersed!in!liqu id!or!sp lash ed !w ith!liqu id.!
!
Changing'date'and'time'
1. Press! !!
2. Press! !you!will!then!be!asked!for!a!4!digit!PIN!code,!this!is!available!for!service!trained!
personnel.!!
3. Press! you!can!then!select!either!d-m-y!or!m-d-y!for!the!date!format!and!12h!or!24h!for!the!
time!format!
4. Dates!and!times!are!then!adjusted!by!selecting!the!number!you!wish!to!change!and!pressing!
or! !to!increase!and!decrease!
5. Press! !to!save!your!settings.!
!
Routine'Maintenance'
1. The!device!must!be!calibrated!once!every!4!weeks!with!a!Bedfont!supplied!calibration!kit!and!
associated!gas,!see!‘Calibration’.!
2. Bedfont!recommend!an!annual!service!in!order!to!check!sensor!and!component!parts!
performance.!!
3. The!H2!sensor!should!be!replaced!every!two!years.!
4. The!O2!sensor!should!be!replaced!every!two!years.!
5. The!CH4!sensor!should!be!replaced!every!two!years.!
6. The!monitor!will!provide!daily!reminders,!via!the!reminder!screen! ,!after!turning!on!the !
GastroCH₄ECK™!for!2!months!leading!up!to!the!sensor!change !du e!d ate.!!
7. Once!this!date!has!elapsed!the!date!will!turn!red!to!indicate!that!sensor!replacement!is!overdue,!
IMPORTANT!this!m ay !com p rom ise !resu lt!accu racy .!!
8. Additional!technical!information!can!be!made!available!on!request;!please!contact!Bedfont!or!its!
distributor.!
!
'Calibration'
The!GastroCH4ECK™!Gastrolyzer®!is!calibrated!at!21°c!+3°c!(69.8°F!+5.4°F)!before!leaving!Bedfont.!
The!instrument!should!be!calibrated!at!21°c!+3°c!(69.8°F!+5.4°F)!as!this!is!the!temperature!at!which!
we!recommend!it!is!to!be!used.!The!GastroCH4ECK™!Gastrolyzer®!should!be!calibrated!every!4!weeks!
!
!
18!
!
!
GastroCH4ECK
TM
Gastrolyzer®
and!will!give!a!reminder!during!start-up!when!calibration!is!due.!The!calibration!gas!required!is!
100ppm!H2,!100ppm!CH4!and!20.9%!O2.!!
1. Turn!on!the!monitor!by!pressing!the!power!button!once.!
2. Press! .!
3. Start!the!calibration!process!by!pressing! .!
4. First!the!monitor!must!be!zeroed!and!this!will!happen!automatically,!showing!this!symbo l! !
once!the!calibration!process!has!started,!do!not!connect!gas!at!this!stage.!
5. Once!this!has!been!successfully!carried!out!the!first!step!of!the!calibration!process!will!be!shown!
onscreen,!indicating!you!to!use!the!correct!gas!mixture! .!Then!select!the!arrow!at!the!
bottom!right!of!the!screen!to!move!to!the!next!instruction.! !
6. The!next!instruction!on!screen!will!show!you!to!attach!the!regulator!to!the!gas!cylinder,!as!
shown! .!Then!select!the!arrow!at!the!bottom!right!of!the!screen!to!move!to!the!next!
instruction.!
7. The!next!instruction!onscreen!will!indicate!for!you!to!attach!the!calibration!adaptor!to!the!end!of!
the!direct!sample!line!and!then!open!the!gas!regulator .!Then!select!the!
arrow!at!the!bottom!right!hand!side!of!the!screen!to!start!the!calibration!process!!
8. Gas'flow'should'be'set'to'1'litre'per'minute.'
9. A!successful!calibration!will!be!indicated!by!the ,!press! !to!return!to!the!home!screen .!
10. A!failed!calibration!will!be!indicated!by ,!press! !to!attempt!calibration!again.!If!the!
problem!persists!see!‘Troubleshooting’!or!call!your!local!supplier!of!Bedfont!products.!!
11. Return!to!the!home!screen!by!pressing! .!
!
GastroCHART™'Software'–'Connecting'to'the'PC'
Place!one!end!of!the!connection!lead!into!the!USB!socket!at!the!rear!of!the!GastroCH4ECK™!
Gastrolyzer®,!connecting!the!other!end!to!the!USB!port!on!the!PC.!Before!starting!the!software,!
ensure!that!the!GastroCH4ECK™!Gastrolyzer®!is!connected!to!the!PC!and!switched!on.!Double!click!
the!GastroCHART™!icon!on!the!PC !to!start!th e!pro gramme.!Refer!to!the!supplied!docume nta tion !for!
how!to!operate!GastroCHART™.!(GastroCHART™!available!to!download!for!FREE!at!
www.bedfont.com)!
!
!
!
19!
!
!
GastroCH4ECK
TM
Gastrolyzer®
'
'
Returns'Procedure'
If!your!equipment!re q u ire s !se rv icin g ,!p le as e !co n t ac t!y o u r!lo c a l!B ed f o n t!C u s to mer!Service!
Department,!distributor!or!supplier!before!returning!any!goods.!!
1. When!you!have!supplied!the!Customer!Repairs!Department!with!the!monitor!serial!number!and!
description!of!the!fault,!you!will!be!issued!with!a!returns/!ticket!number.!Please!state!the!
returns/ticket!number!on!the!outside!o f!the!b ox !wh en !return ing !the!m o n itor,!and !ensu re!th at!
your!full!details,!telephone,!fax!numbers!and!return!address!are!clearly!stated.!!
2. The!product!must!also!be!decontaminated!before!it!is!returned!according!to!your!local!
regulations.!Bedfont!can!provide!you!w ith!a !dec on tam in atio n!ce rtificate!to!complete,!which!also!
needs!to!be!attached!to!the!outside!of!the!box.!Failure!to!do!so!will!result!in!the!product!being!
subject!to!Bedfont!decontamination!procedure!and!will!delay!your!service/repair!and!may!incur!
costs!to!yourself.!
3. Bedfont!advise!that!you!use!a!courier!service!when!returning!monitors.!This!enables!you!to !
insure!goods!for!loss!or!d a mage!in!transit.!When!y ou r!g o o d s!a re !re ce iv ed ,!yo u !will!be!sent!an!
email!stating!so.!!
4. If!the!device!has!been !re tu rn e d !for!repair!it!will!then!be!e xa mined!and!you!will!be!sent!an!
‘Engineer’s!Report’!a n d!a!quotation!for!th e !re p a ir ,!w hich!will!include!an !a u th orisation!form.!
Complete!the!authorisation!form,!and!ensure!that!you!include!the!‘Official!Purchase!Order!
Number’.!Please!contact!the!Customer!Repairs!Department!if!you!are!una ble!to !sup ply!an !
‘Official!Purchase!O rder!Number’.!
5. If!your!monitor!is!still!in!warranty!and!the!fau lt!is !co v e re d !b y!warranty,!see!‘Warran ty ’!se ct io n !o f!
this!manual,!Bedfont!will!repair!it!and!return!it!to!you!w ith!an !‘Engine er’s!Re po rt’,!fre e !o f !charge.!!
6. If!you!choose!not!to !p ro c ee d !with!the!repair,!a!hand lin g !fe e!will!be!charged.!Ensur e!t h a t!y o u !
return!the!completed!authorisation!fo rm !w ith!an !‘Official!Pu rch ase !Ord er!N umber’.!!
7. The!equipment!will!be!returned!to!you!as!soon!as!Bedfont!has!received!all!relevant!paperw o rk.!A!
carriage!fee!will!be!charged!if!the!monitor!is!no!longer!in!warranty.!
'
Warranty'
Bedfont!Scientific!Limited!warrants!the!GastroCH4ECK™!Gastrolyzer®!product!(excluding!H2,!O2!and!
CH4!sensors)!to!be!free!of!defects!in!materials!and!w o rkm a nsh ip !for!a!pe riod !of!tw o!ye ars !from !the !
date!of!shipment.!The!H2!and!O2!sensor!is!warranted!for!12!months!and!the!CH4!sensor!is!warranted!
for!24!months,!this!does!not!include!servic e!item s .!!
Bedfont’s!sole!obligation!under!this!warranty !is !lim it ed !t o!r ep a irin g !o r!re pla c in g,!a t!it s!choice,!any!
item!covered!under!th is!warranty!when!such!a n !ite m !is !re tu rn e d ,!int a ct!a n d !p re pa id ,!to !B e d fo nt !
Scientific!Limited!or!the!local!representative.!
!
!
20!
!
!
GastroCH4ECK
TM
Gastrolyzer®
This!warranty!is!automatically!invalidated!if!the!products!are!repaired ;!a lte re d,!v o id !lab e ls!
removed!or!otherwise!tampere d!w ith!b y!un au tho rised !pers on ne l,!or!hav e!be en !sub ject!to!m isuse,!
neglect!or!accident.!At!the!end!of!the!product’s!life,!contact!Bedfont!or!its!distributor!for!disposal!
instructions.!
Single!use!consumables!and!accessories!should!be!disposed!of!in!line!with!local!clinical!waste!
guidelines.!
!
Testing'Protocol'Thresholds'
Below!is!an!interpretation!table!for!general!guidance!on!interpreting!the!H2!and!CH4!values!for!
supporting!a!diagnosis!of!conditions.!Other!factors!through!qualified!judgement!need!to!be!taken!in!
account!by!looking!at!the!patient!history,!on-going!symptoms!and!symptoms!during!test.!H2!and!CH4!
readings!can!be!interpreted!as!positive!or!neg ative !usin g!the!following!pre-set!thresholds!(this!is!the!
increase!in!reading!compared!to!the!base!sample):!
Test'
Positive'Interpretation'
Lactose
2,'3
'
H2!>20ppm!CH4!>12ppm!compared!to!base!sample!
Lactulose4'
H2!&!CH4!>20ppm!compared!to!base!sample!within!90!minutes!of!lactulose!
ingestion!
Lactulose2'SIBO*'
a)!Early!increase!of!at!least!20ppm!for!the!sum!of!the!two!gases!
b)!Increase!>20ppm!corresponding!to!the!appearance!of!lactulose!in!the!colon!
Lactulose2'IITT**'
Fast!>20ppm!peak!is!detected!at!60!minutes!
Normal!>20ppm!peak!is!detected!at!80!minutes!
Slow!>20ppm!peak!is!detected!100!minutes!or!later!
Fructose2'
H2!>20ppm!CH4!>12ppm!compared!to!base!sample!
Sorbitol3'
H2!>20ppm!compared!to!base!sample!
Xylitol3'
H2!>20ppm!compared!to!base!sample!
Glucose3'
H2!>10ppm!CH4!>10ppm!compared!with!base!sample!
*SIBO!=!Small!Intestinal!Bacterial!Overgrowth!
**IITT!=!Impaired!Intestinal!Transit!Time!
!
References'
1. Levitt,!M.D.!(1969):!Production!and!excretion!of!H2!gas!in!man.!New!Engl.!J.Med.!281:122-127!
2. Biolab!Medical!Unit;!Nutritional!and!Environmental!Medicine;!London!England.!Breath!Hydrogen!
and!Methane!February!2012.!Available!at!http://www.biolab.co.uk/docs/bhydro.pdf!!
3. Ledochowski!M.!Ledochowski!E.!Hydrogen!Breath!Tests!2008;!Available!from!Bedfont!Scientific!!
4. Pimental!M.!et!al!Methane!Production!during!Lactulose!Breath!Test!is!Associated!with!
Gastrointestinal!Disease!Presentation.!Digestive!Diseases!and!Sciences.!Vol.!48!No.!1!2003!
!
!
!
21!
!
!
GastroCH4ECK
TM
Gastrolyzer®
'
Spares''
GASTROCHECK-MP'
100!mouthpieces!for!GastroCH4ECK™!on-line!measurement!
GASTROCHECK-MP-XL'
250!mouthpieces!for!GastroCH4ECK™!on-line!measurement!
GASTROCHECK-BAG'
100!breath!bags!and!100!breath!bag!mouthpieces!for!GastroCH4ECK™!
GASTROCHECK-BAG-XL'
250!breath!bags!and!250!breath!bag!mouthpieces!for!GastroCH4ECK™!
GASTROCHECK-DESS'
'
Moisture!removal!filter!for!GastroCH4ECK™!(only!required!if!using!
breath!bags)!last!for!150!tests!or!3!months!
GASTROCHECK-DESS-XL'
'
Moisture!removal!filters!for!GastroCH4ECK™!pack!of!5!(only!required!if!
using!breath!bags)!filters!last!for!150!tests!or!3!months!
GASTROCHECK-CAL-KIT'
'
34*ltr!calibration!kit!-!100ppm!Hydrogen,!100ppm!Methane,!20.9%!
Air!with!regulator!
GASTROCHECK-CAL'
34*ltr!replacement!canister!100ppm!Hydrogen,!100ppm!Methane,!
20.9%!Air!
GASTROCHECKCALIADAP'
Calibration!adapter!for!GastroCH₄ECK™!
REG1.0L-V'
1!ltr!Regulator!for!use!with!34*!&!112!ltr!Cylinders!
WIPE-V'
Pack!of!50!wipes!
ISSA-BB'
Face!mask!sampling!system!for!use!with!GastroCH₄ECK™!breath!bags!
TEST-LACTOSE'
Home!care!breath!testing!kit!for!lactose!intolerance.!Substrate!not!
included!
TEST-FRUCTOSE'
Home!care!breath!testing!kit!for!fructose!intolerance.!Substrate!not!
included!
TEST-LACTULOSE'
'
Home!care!breath!testing!kit!for!small!intestinal!bacterial!overgrowth!
(SIBO).!Substrate!not!included!
! *Filled!to!27!ltr.!
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Kent, ME17 1JA England
Tel: +44 (0)1622 851122 Fax: +44 (0)1622 854860
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Issue 1- August 2016, Part No: LAB723
Bedfont Scientic Limited reserves the right to change or update this literature without prior notice.
Registered in: England and Wales. Registered No: 1289798
© Bedfont Scientic Limited 2016
Contact Bedfont or one of our worldwide Gastrolyzer®
distributors for a free demonstration
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