User manual
0086
Our family, innovang health, for yours.
GastroCH4ECK
®
Gastrolyzer
®
GastroCH4ECK Gastrolyzer
®®
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Our$family,$innovating$health,$for$yours.$
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Definitions!.................................................................................................................................................!2!
Intended!use!.............................................................................................................................................!2!
Introduction!..............................................................................................................................................!2!
Safety!notes!...............................................................................................................................................!3!
Contraindications!......................................................................................................................................!3!
Safety!during!installation!and/or!maintenance!........................................................................................!3!
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!contents!...........................................................................................................................!11!
Technical!specification!............................................................................................................................!11!
Display!symbols!.......................................................................................................................................!12!
Warnings!and!maintenance!....................................................................................................................!16!
Cleaning!...................................................................................................................................................!18!
Routine!maintenance!..............................................................................................................................!18!
Calibration!...............................................................................................................................................!18!
GastroCHART™!software!–!connecting!to!the!PC!....................................................................................!19!
Troubleshooting!procedure!....................................................................................................................!20!
Returns!procedure!..................................................................................................................................!20!
Warranty!.................................................................................................................................................!21!
Testing!protocol!thresholds!....................................................................................................................!22!
References!...............................................................................................................................................!22!
Spares!......................................................................................................................................................!22!
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!+,-./0,*indicates!a!potentia lly!h a za rd o u s!s itu a tio n ,!w h ich ,!if!n o t!a v o ide d ,!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).!!
.12/3-+0-,!is !u se d !fo r!co mments!that!add!valu e!t o !th e !ste p !o r!p ro c edure!being!performed.!
Following!the!.12/3-+0-!advice!adds!benefit!to!the!performance !of!the!equipment!or!to!a!process.!
0/-4,!is!used!to!call!attention !to !n o ta b le!in fo rmation!that!should!be!f o llowed!during!installation,!
use,!or!servicing!of!the!equipment.!
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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!m on itor!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!aid!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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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!can!then!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!
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Our$family,$innovating$health,$for$yours.$
measurement!of!H2!and!CH4!in!parts!per!million!(ppm)!in!expiratory!air!reveals!in to le ra n ce !an d / o r!
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!sa m ple!is!tha t!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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To!avoid!electric!shock,!this!equipment!must!be!connected!to!a!mains!supply!with!protective!earthgrounding.!!
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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If!exhaling!gently!to!pro d u c e !a!b r e at h !sa mple!is!physically!dema n d in g !th e n !it!ma y!c au s e!
contraindications!in!patients!who!have!had!a!recent!myocardial!infarction.!Also!extensive!exhalation!
might!lead!to!syncope.!
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The!GastroCH4ECK®!Gastrolyzer®!can!be!installed!by!a!trained!user!as!lo ng!as!the!instruction!manual!
has!been!read.!The!GastroCH4ECK®!Gastrolyzer®!weighs!8kg.!!
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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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!m echanical!components.!
• Only!use!properly!rated!safety!fuses!as!described!on!the!rear!of!the!GastroCH4ECK®!(T!3.15!
AH!250V).!
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Fuses!protect!certain!electrical!circuits!within!the!GastroCH4ECK®!Gastrolyzer®!against!overcurrent!
conditions.!For!continued!protection!against!the!risk!of!fire,!replace!only!with!the!same!type!and!
rating!specified.!!
Only!fuses!with!the!following!ratings!should!be!applied:!250Vac,!3.15AH!T,!1500A!breaking!capacity.!
The!GastroCH4ECK®!Gastrolyzer®!is!not!designed!for!use!with!mate ria ls!c ap a b le!o f !de v elo p in g !
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!30cm!(1ft)!area!surrounding!the!GastroCH4ECK®!
Gastrolyzer®.!!
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For!safe!operation!of!the!equipment,!observe!the!following:!!
Use!only!accessories!designed!for!use!with!the!GastroCH4ECK®!Gastrolyzer®.!!
Do!not!lift!or!move!the!GastroCH4ECK®!Gastrolyzer®!while!it!is!running.!This!could!damage!the!
methane!bench.!!!
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The!GastroCH4ECK®!Gastrolyzer®!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®!Gastrolyzer®!is!intended!for!the!use!in!the!electroma g n et ic!e n viro n ment!specified!
below.!The!customer!or!the!user!of!the!GastroCH4ECK®!Gastrolyzer®!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!immunity!
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Radiated!immunity!
3!V!rms!150!khz!~!
80mhz!outside!ISM!
bands*!!
3V!(1khz!80%)!
150khz!–!80mhz!
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3!V/m!80!mhz!~!2.5!
ghz!!
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3V!(1khz!80%)!
150khz!–!80mhz!
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80!mhz!to!2.5!ghz!
3!V/m!
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Portable!and!mobile!RF!
communications!equipment!should!
be!used!no!closer!to!any!part!of!the!
GastroCH4ECK®!Gastrolyzer®!
including!cables,!than!the!
recommended!separation!d istan ce!
calculated!from!the!equation!
appropriate!to!the!frequency!of!the!
transmitter.!!
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Interference!may!occ u r!in !t h e!
vicinity!of!equipment!marked!with!
the!following!symbol:!!
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0/-4*CD!At!80!mhz!and!800!mhz,!th e !h ig h e r!f re q uency!range!applies .!!
0/-4*ED!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!environme nt!d ue !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®!Gastrolyzer®!is!used!exceeds!the!applicable!RF!compliance!level!
above,!the!GastroCH4ECK®!Gastrolyzer®!should!be!observed!to!verify!normal!operation.!If!abnormal!
performance!is!observed,!additional!measures!may!be!necessary,!such!as!reorienting!or!relocating!the!
GastroCH4ECK®!Gastrolyzer®.!!
Over!the!frequency!ranges!150!khz!to!80!mhz!field!strength!should!be!less!than!3!V/m.!
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!+,-./0D*If!the!GastroCH4ECK®!Gastrolyzer®!is!used!in!a!manner!other!than!tha t !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.!*
!+,-./0D*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.*
!+,-./0D*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.!!
!+,-./0D*Do!not!apply!pressures!greater!than!4!bar!to!the!direct!sample!line!connector,!at!a!
maximum!flow!rate!of!3!LPM.!!Doing!so!could!result!in!the!disconnection!of!internal!tubing!to!
protect!against!sensor!damage.!
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Class!I!equipment;!(earthed)!
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IPX0!–!not!protected!against!water!
ingress!
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Equipment!not!suitable!for!use!in!the!
presence!of!flammable!mixtures.!
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Maintain!a!30cm!(1ft)!clearance!envelope!above!the!GastroCH4ECK®!Gastrolyzer®!while!it!is!running.!
The!equipment!should!not!be!positioned!in!such!a!way!that!it!is!difficult!to!operate!the!
disconnection!device!(mains!plug).!If!it!is!necessary!to!m o v e!t h e !GastroCH4ECK®!Gastrolyzer®,!then!
the!following!conditions!need!to!be!main taine d:!
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!c a n!s u p p o rt!th e !w e ig h t!o f!t he!GastroCH4ECK®!Gastrolyzer®,!8!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!15cm!(6in)!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).!
1"#)$"7*&%$P6G*
1. Connect!the!power!lead!to!the!GastroCH4ECK®!Gastrolyzer®!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!screen!will!light!
up!and!the!unit!will!proceed!to!the!warm!up!screen.!!If!any!warning!screens!are!displayed,!
these!should!be!checked!in!the!warnin gs!an d!erro rs!sec tion!o f!the!m a nu al.!The!
GastroCH4ECK®!Gastrolyzer®!monitor!warm!up!takes!30!minutes,!see!‘temperature!
requirements’,!and!a!countdow n!timer!will!be!shown!onscreen!for!the!duration!of!the!warm !
up!as!shown:!
0/-4D!The!warm-up!time!can!be!shortened!if!the!unit!is!already!warmed-up.!
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3. 5!minutes!before!the!completion!of!the!warm!up,!the!GastroCH4ECK®!Gastrolyzer®!will!begin!
a!purge!cycle!to!clear!any!residual!gas!in!the!tubing.!
4. Connect!the!sample!line!to!the!direct!sample!line!connector!for!breath!samples,!ensuring!the!
connecter!‘clicks’!fully!into!place!or!push!the!moisture!filter!onto!th e!bag!sample!connector!
for!breath!bag!sampling.!!
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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!23°c!±3°c!
(69.8°F!±!5.4°F).!!
0/-4D*At!25°c!ambient!temperature!the!expected!lifetime!of!the!unit!is!at!least!30,000!hrs.!For!every!
10°c!rise!in!temperature,!the!lifetime!is!reduced!by!half.!
The!unit!requires!a!warm!up!time!of!30!minutes!before!it!can!be!used.!After!2!minutes,!the!unit!
periodically!does!a!self- ch eck!in!order!to!know!if!it!is!ready!to!be!used.!In!the!case!it!is!detected!to!be!
ready,!a!bypass!option!is!provided.This!bypass!should!only!be!used!if!the!unit!is!accidently!switched!
off!or!needs!to!be!moved!after!it!has!already!warmed!up.!T he!bypass!must!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’s!home!screen.!!
0/-4D*The!instrument!should!be!calibrated!prior!to!first!use,!after!transportation!and!every!4!weeks.*
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1. Once!the!warm!up!has!been!completed,!atta ch!th e!sam p le!line!an d!a!breath!sampling!
mouthpiece.!!
2. Press !to!begin.!
3. A!timer! !will!be!shown!onscreen,!whilst!the!sensors!are!zeroing.!This!may!take!up!to!75!
seconds!if!a!test!has!just!been !c ar rie d!o u t.!
4. If!you!are!using!Gastro C H A R T ™!to!record!the!readin g s,!make!sure!you!are!on!t h e !p at ien t ’s!
profile!and!click!‘capture!reading’!now.!
5. Inhale!when!prompted!by! and!hold!breath!for!the!pre-set!15!second!countdown,!as!
shown!on!screen.!!
6. A!beep!will!sound!during!the!last!three!seconds!of!the!countdown .!!
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7. Blow!slowly!into!mouthpiece!when!prom pted!by! .!
8. An!indicator!on-screen!will!illustrate!how!hard!to!blow ;!keep!the!arrow!pointing!in!
the!green!section!of!this!indicator!throughout!th e!test.!!
9. The!arrow!will!change!colour!as!the!O2!level!in!the!breath!sam p le !re du c e s!to !t h e!t arg e t!1 5 % ,!
at!which!point!it!will!turn!green!and!the!test!will!automatically!stop!after!3!seconds!
.!
10. If!the!patient!fe els !th e y !ar e!u nable!to!exhale!for!any !lo n g er !an d !t h e !te st !h as !n o t!f in ish e d !
they!can!end!the!test!at!any!time!by!pressing! .!
11. The!final!results!will!be!shown!on! screen! .!
12. 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!and!another!test!is!recommended!
13. Press! !to!return!to!the!results!screen.!
14. When!you!are!finished,!press! !to!return!to!the!home!screen.!0/-4D!this!will!lose!the!
reading;!please!ensure!you!have!downloaded!the!results!to!GastroCHART™!or!recorded!
them!manually.!!
15. Remove!the!mouthpiece!and!sample!line!between!tests!to!purge!sensors!with!fresh!air.!
!
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1. Place!two!bag!clamps!over!the!inlet!and!outlet!tubes!o f!the!b reath !ba g,!but!keep!them!open !
!
2. 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!
!
3. With!both!bag!clamps!open,!exhale!gently!through!the!bag!at!a!steady!rate!
4. 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!sam p le!
!
!
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5. As!soon!as!you!feel!your!lungs!are!nearly!empty,!and!end-tidal!breath!has!almost!been!
reached,!engage/close!the!clamp!at!the !ou tlet!of!th e!ba g!
!
6. 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!
!
7. Engage!the!clamp!at!the!inlet!of!the!bag.!
8. Insert!the!blue!plastic!plugs!in!each!end!o f!the!bre ath !ba g!to!ensure!no!breath!is!lost!from!
the!sample.!!
Following$these$steps$should$ensure$that$a$valid$sample$has$been$collected.$
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1. Once!warm!up!has!been!completed,!attach!the!moisture!filter!to!the!device.!
2. Press! to!start!the!bag!test!procedure.!
3. The!device!will!then!illustrate!to!attach!the!breath!bag.!Ensure!to!carefully!remove!the!blue!
plug!on!one!end!only!and!attach!the!bag!to!the!moisture!filter,!then!open!the!clamp!on!that!
end!only!to!preserve!the!sample.!
4. Press! !to!begin.!!
5. A!timer! !will!be!shown!onscreen,!whilst!the!sensors!are!zeroing.!This!may!take!up!to!75!
seconds!if!a!test!has!just!been!carried!out.!
6. If!you!are!using!Gastro C H A R T ™!to!record!the!readin g s,!make!sure!you!are!on!t h e !p at ien t ’s!
profile!and!click!‘capture!reading’!now.!
7. Once!zeroed,!breath!bag!sampling!will!begin!automatically!–!make!sure!that!the!clamp!is!
open.!At!this!point,!the!device!needs!no!further!intervention!until!a!reading!is!recorded.!
8. The!device!will!draw!the!breath!sample!for! an alysis;!this!will!take!45!secon ds ,!as!indica te d !on !
the!screen.!
9. The!final!results!will!be!show n!on!screen .!
10. 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!
!
!
11!
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Our$family,$innovating$health,$for$yours.$
b. Satisfactory!test,!correction!factor!applied!
c. Poor!test,!high!correction!factor!applied !and !an oth er!test!is!reco m m e nd ed!
11. Press! !to!return!to!the!results!screen.!
12. When!you!are!finished,!press! !to!return!to!the!home!screen.!0/-4D!this!will!lose!the!
reading;!please!ensure!you!have!downloaded!the!results!to!GastroCHART™!or!recorded!
them!manually.!
!
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1. GastroCH4ECK®!Gastrolyzer®!monitor!
7. Direct!sample!line!
2. Operating!manual!
8. Quick!start!guide!
3. Mains!cable!
9. Patient!preparation!guide!
4. GastroCHART™!software!on!USB!!
10. Interpretation !wheel!
5. USB!cable!
11. Ledochowski!book!
6. Moisture!filter!
!
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!"#8%#$7:$)"#*7:#<%**
!RS*
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RE*
0-200!ppm!!
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230V/100V,!50Hz!–!60!Hz,!0.5!–!1.0!A!
M6&%*
T!3.15!AH!
N:7?P6G*$)?%*
30!minutes!
!:=)F7:$)"#*(7%H6%#8;**
Every!4!weeks!!
')&G=:;*
Full!colour!touchscreen!
'%$%8$)"#*G7)#8)G=%*
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Infrared!(CH4)!
*
*
*
*
+8867:8;**
*
!RS*
3%&"=6$)"#*
1!ppm!
+8867:8;*
±!10%!of!reading!!
3%G%:$:F)=)$;*
<5%!difference!on!consecutive!readings!
*
RE*
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1!ppm!
+8867:8;*
±!10%!of!reading!!
3%G%:$:F)=)$;*
<5%!difference!on!consecutive!readings!
*
/E*
3%&"=6$)"#*
0.1%!
+8867:8;*
±!2.5%!of!reading!!
3%G%:$:F)=)$;*
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15-35°C!(59°-!95°F)!
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27%&&67%*7:#<%**
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900-1100mbar!
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1"#)$"7*8"#&$768$)"#*
Case:!aluminium!
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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!
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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!will!invalidate!the!warranty!and!may!
compromise!the!safety!of!the!device.!!
4. Bedfont®!will!make!available,!upon!request,!service!training!to!appropriately!qualified!
persons.!
V2.23
!
!
17!
!
!
Our$family,$innovating$health,$for$yours.$
5. Pressing!the!reset!button! !will!prompt!the!device!to!calibrate!without!taking!into!
account!the!sensor’s!safety!windows.!You!will!be!asked!to!confirm!your!choice;!click!to!
confirm.!If!completed,!new!sa fe ty!windows!and!calibration!coefficients!are!saved.!The!next!
calibration!needed!is!in!4!weeks.!To!abort,!click! .!Aborting!the!reset!calibration!
before!the!gas!is!sampled!will!revert!the!calibration!back!to!the!previous!settings.!!
! !
!
!
18!
!
!
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0/-4:!Only!available!if!the!unit !h as !b e e n !o n !fo r!1 !h our,!from!switch!on.!If!n o t ,!th e !re s et !
button!is!in!grey! !
6. The!GastroCH4ECK®!should!we!switched!off!once!every!24!hours.!
!
!=%:#)#<*
1. Bedfont®!recommends!wiping!the!instrument’s!external!surfaces!with!a!product!specifically!
developed!for!this!purpose.!Bedfont®!provides!instrument!cleaning!wipes.!The!device!or!
consumables!cannot!be!sterilised.!
2. 04Y43!use!alcohol!or!cleaning!agents!containing!alcohol!or!other!organic!solvents!as!long!
term!exposure!to!these!vapours!will!da mage!the!sensors!insid e .!!
3. Under!no!circumstances!should!the!instrument!be!immersed!in!liquid!or!splashed!with!
liquid.!
!
3"6$)#%*?:)#$%#:#8%*
1. The!device!must!be!calibrated!once!every!4!weeks!with!a!Bedfont®!calibration!kit!and!
associated!gas,!see!‘calibration’.!
2. Bedfont®!recommends!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!five!years.!
6. The!monitor!will!provide!daily!reminders,! ,!via!the!reminder!sc re e n !a f te r !tu r n in g !o n !t h e !
GastroCH₄ECK®!Gastrolyzer®!for!1!month!leading!up!to!the!sensor!change!due!date.!!
7. Once!this!date!has!elapsed!the!date!will!turn!red!to!indicate!that!sen sor!replacem ent!is!
overdue.!
.12/3-+0-D!This!may!compromise!result!accuracy.!!
8. Additional!technical!information!can!be!made!available!on!request;!please!contact!Bedfont®!
or!its!distributor.!
!:=)F7:$)"#*
The!GastroCH4ECK®*Gastrolyzer®!is!calibrated!at!21°c!+3°c!(69.8°F!+5.4°F)!before!leaving!Bedfont®.!
The!instrument!should!be!calibrated!at!21°c!+3°c!(69.8°F!+5.4°F)!as!this!is!the!temperature!at!which!
we!recommend!it!is!to!be!used.!The!GastroCH4ECK®*Gastrolyzer®!should!be!calibrated!every!4!weeks!
and!will!give!a!reminder!during!start-up!when!calibration!is!due.!The!calibration!gas!required!is!
100ppm!H2,!100ppm!CH4!and!20.9%!O2.!!
!
!
19!
!
!
Our$family,$innovating$health,$for$yours.$
1. Make!sure!the!monitor!is!plugged!in!at!the!mains!and!switched!on!at!the!back.*0/-4D!
calibration!is!only!possible!if!the!unit!has!been!on!for!1!hour,!from!switch!on.!If!not,!a!red!
crossed!circle!is!displayed!on!top!of!the!image! .!
2. Press! .!
3. Start!the!calibration!process!by!pressing! .!
4. First!the!monitor!must!be!zeroed!and!this!will!happen!automatically,!showing!this!symbol!
.!Once!the!calibration!proc es s!h as !sta rte d,!d o !no t!c o nn e ct !the !ga s!a t!th is!sta g e.!
5. Once!this!has!been!successfully!carried!out,!the !first!step!of!th e!calibra tion !pro cess!w ill!be!
shown!onscreen!indicating!for!you!to!use!the!co rrect!ga s!m ixtu re! .!Then!select!the!
arrow!at!the!bottom!right!of!the!screen!to!m ove!to!the!next!instruction.!!
6. The!next!instruction!on!screen!will!ask!you!to!attach!the!regulator!to!the!gas!cylinder,!as!
shown! .!T h en !se le ct !th e !arr ow!at!the!bottom!right!o f!th e !sc re en !t o!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 .!
Select!the!arrow!at!the!bottom!right!hand!side!of!the!screen!to!start!the!calibration!process!!
Z[ Q:&*(="J*&A"6=5*F%*&%$*$"*C*=)$7%*G%7*? )#6$%[**
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.!!
Return!to!the!home!screen!by!pressing! .!
Q:&$7"!R+3-\*&"($J:7%*]*8"##%8$)#<*$"*$A%*2!*
The!GastroCHART™!software!can!be!downloaded!and!installed!from!the!USB!that!comes!with!the!
GastroCH4ECK®!Gastrolyzer®.!Place!one!end!of!the!connection!lead!into!the!USB!socket!at!the!rear!of!
the!GastroCH4ECK®*Gastrolyzer®,!connecting!the!other!end!to!the!USB!port!on!the!PC.!Before!
starting!the!software,!ensure!that!the!GastroCH4ECK®*Gastrolyzer®!is!connected!to!the!PC!and!
switched!on.!Double!click!the!GastroCHART™!icon!on!the!PC!to!start!the!programme.!Refer!to!the!
supplied!documentation!for!how!to!operate!GastroCHART™.!(GastroCHART™!is!also!available!to!
download!for!M344!at!www.bedfont.com)!
!
!
20!
!
!
Our$family,$innovating$health,$for$yours.$
!
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Please!refer!to!the!following!table!for!troubleshooting!any!error!codes:!
RE*&%#&"7*U%7"*(:)=67%*
!
Reattempt!breath!or!
breath!test.!
!
If!failure!persists!contact !
Bedfont®!or!your!
distributor!for!support.!
/E*&%#&"7*U%7"*(:)=67%*
!
Reattempt!breath!or!
breath!test.!
!
If!failure!persists!contact !
Bedfont®!or!your!
distributor!for!support.!
!RS*&%#&"7*U%7"*%77"7*
!
Reattempt!breath!or!
breath!test.!
!
Wait!longer!for!the!unit!
to!warm!up.!
!
If!failure!persists!contact !
Bedfont®!or!your!
distributor!for!support.!
!RS*&%#&"7*8"??6#)8:$)"#*
%77"7**
*
V:GG%:7&*(7"?*$%&$*&87%%#&W*
!
Reattempt!breath!or!
breath!test!or!calibration.!
!
If!failure!persists!contact !
Bedfont®!or!your!
distributor!for!support.!
!:=)F7:$)"#*(:)=%5!
!
V:GG%:7&*(7"?*8:=)F7:$)"#*
&87%%#W*
!
Check!calibration!gas!
tubing!is!connected!to!
the!breath!sampling!port.!
Reattempt!calibration.!
If!failure!persists!contact !
Bedfont®!or!your!
distributor!for!support.!
!
3%$67#&*G7"8%567%*
If!your!equipment!re q u ire s !se rv icin g ,!p le as e !co n t ac t!y o u r!lo c a l!Bedfont®!customer!service!
department,!distributor!or!supplier!before!returning!any!goods.!!
1. When!you!have!supplied!the!customer!repairs!department!with!the!monitor!serial!number!
and!description!of!the!fault,!you!will!be!issued!with!a!returns/!ticket!number.!Please!state!
the!returns/ticket!number!on!the!outside!of!the!box!wh en!returning!the!m on itor,!and!
!
!
21!
!
!
Our$family,$innovating$health,$for$yours.$
ensure!that!your!full!details,!telephon e!and!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!with!a!decontamination!certificate!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®!advises!that!you!use!a!courier!service!when!returnin g!m on itors.!Th is!ena bles !you !
to!insure!goods!for!loss!or!damage!in!transit.!Wh en !you r!goo ds !are!rec eived ,!you !will!be!se nt!
an!email!stating!so.!!
4. If!the!device!has!been!returned!for!repair!it!will!then!be!examined!and!you!will!be!sent!an!
‘engineer’s!report’!and!a!quotation!for!the!repair,!which!will!include!an!authorisation!form.!
Complete!the!authorisation!form,!and!ensure!that!you!include!the!‘official!purchase!order!
number’.!Please!contact!the!customer!repairs!department!if!yo u !are !u n a b le!t o!s u p p ly!a n !
‘official!purchase!order!number’.!
5. If!your!monitor!is!still!in!warranty!and!the!fault !is!c o ve re d !b y !w a rr a n ty,!s e e!the!‘warranty’!
section!of!this!manual;!Bedfont®!will!repair!it!and!return!it!to!you!with!an!‘engineer’s!report’,!
free!of!charge.!!
6. If!you!choose!not!to !p ro c ee d !with!the!repair,!a!handlin g !fe e !w ill!b e !c h ar g ed .!E n s u re !that!you!
return!the!completed!authorisation!fo rm !w ith!an !‘official!purchase!order!number’.!!
7. The!equipment!will!be!returned!to!you!as!soon!as!Bedfont®!has!received!all!relevant!
paperwork.!A!carriage!fee!will!be!charged!if!the!monitor!is!no!longer!in!warranty.!
!
N:77:#$;*
Bedfont®!Scientific!Limited!warrants!the!GastroCH4ECK®!Gastrolyzer®!product,!sen sors!excepted,!to!
be!free!of!defects!in!materials!and!workmanship!for!a!period!of!2!years!from!the!date!of!shipment.!
The!H2,!O2!and!CH4!sensors!are!guaranteed!for!a!period!of!1!year!only!from!the!date !of!sh ipm e nt!
from!Bedfont®.!
Bedfont’s!sole!obligation!under!this!warranty!is!limited!to!repairing!or!replacing,!at!its!choice,!any!
item!covered!under!th is!warranty!when!such!an !it em!is!returned,!intact!and!p re p aid ,!to ! Bedfont®!
Scientific!Limited!or!the!local!representative.!
This!warranty!is!automatically!invalidated!if!the!products!are!repaired;!altered,!void!labels!removed!
or!otherwise!tampered!with!by!unauthorised!personnel,!or!have!been!subject!to!misuse,!neglect!or!
accident.!At!the!end!of!the!product’s!life,!contact!Bedfont®!or!its!distributor!for!disposal!instructions.!
Single!use!consumables!and!accessories!should!be!disposed!of!in!line!with!local!clinical!waste!
guidelines.!
!
!
!
!
!
!
22!
!
!
Our$family,$innovating$health,$for$yours.$
Never! dispose! of! any! electronic! instrument! or! batteries! in! domestic! waste.! At! the! end! of! the!
product’s!life,!contact!Bedfont®!or!its!distributo r!for!disp osa l!instru ction s.!
!
-%&$)#<*G7"$"8"=*$A7%&A"=5&*
Below!is!an!interpretation!table!for!general!guidance!on!interpreting!the!H2!and!CH4!values!for!
supporting!a!diagnosis!of!conditions.!Other!factors!through!qualified!judgement!need!to!be!taken!in!
account!by!looking!at!the!patient!history,!on -going!symptom s!and!symptom s!during!test.!H2!and!CH4!
readings!can!be!interpreted!as!positive!or!neg ative !usin g!the !follow ing !pre-set!thresholds!(this!is!the!
increase!in!reading!compared!to!the!base!sample):!
-%&$*
2"&)$)B%*)#$%7G7%$:$)"#*
^:8$"&%
EK*_
*
H2!>20ppm!CH4!>12ppm!compared!to!base!sample!
^:8$6="&%S*
H2!&!CH4!>20ppm!compared!to!base!sample!within!90!minutes!of!lactulose!
ingestion!
^:8$6="&%E*9.L/`*
A)!Early!increase!of!at!least!2 0 p p m!for!the!sum!of!the!two !g as e s!
B)!Increase!>20ppm!correspo nd ing !to!the !app ea ran ce !of!lactu los e!in!the !colo n!
^:8$6="&%E*..--``*
Fast!>20ppm!peak!is!detected!at!60!minutes!
Normal!>20ppm!peak!is!detected!at!80!minutes!
Slow!>20ppm!peak!is!detected!100!min ut e s!o r!la te r!
M768$"&%E*
H2!>20ppm!CH4!>12ppm!compared!to!base!sample!
9"7F)$"=_*
H2!>20ppm!compared!to!base!sample!
a;=)$"=_*
H2!>20ppm!compared!to!base!sample!
Q=68"&%_*
H2!>10ppm!CH4!>10ppm!compared!with!base!sample!
*SIBO!=!Small!Intestinal!Bacterial!Overgrow th !
**IITT!=!Impaired!Intestinal!Transit!Time!
!
3%(%7%#8%&*
1. Levitt,!M.!(1969).!Production!and!Excretion!of!Hydrogen!Gas!in!Man.!New$England$Journal$of$
Medicine,!281(3),!pp.122-127.!
2. Biolab!Medical!Unit,!(2012).!Breath$Hydrogen$and$Methane$Testing$for$SIBO.!Nutritional!and!
Environmental!Medicine.!London:!Biolab!Medical!Unit.!Available!at!
http://www.biolab.co.uk/docs/bhydro.pdf!!
3. Ledochowski,!M.!And!Ledochowski,!L.!(2011).!Hydrogen$Breath$Tests.!2 nd !e d.!A n ich s tra sse :!
Akadmed-Verlag.!Available!from!Bedfont®!Scientific.!
4. Pimental,!M.!Et!al.!(2003).!Methane!Production!during!Lactulose!Breath!Test!is!Associated!
with!Gastrointestinal!Disease!Presentation.!Digestive$Diseases$and$Sciences,!48(1).!
!
9G:7%&**
Q+9-3/!R4!TP12*
100!mouthpieces!for!GastroCH₄ECK®!Gastrolyzer®!online!measurement.!
!
!
23!
!
!
Our$family,$innovating$health,$for$yours.$
Q+9-3/!R4!TP12Pa^*
250!mouthpieces!for!GastroCH₄ECK®!Gastrolyzer®!online!measurement.!
Q+9-3/!R4!TPL+Q*
100!breath!bags!and!100!breath!bag!mouthpieces!for!GastroCH₄ECK®!
Gastrolyzer®.!
Q+9-3/!R4!TPL+QPa^*
250!breath!bags!and!250!breath!bag!mouthpieces!for!GastroCH₄ECK®!
Gastrolyzer®.!
Q+9-3/!R4!TP'499*
*
Moisture!removal!filter!for!GastroCH₄ECK®!Gastrolyzer®!(only!required!if!
using!breath!bags)!last!for!150!tests!or!3!months.!
Q+9-3/!R4!TP'499Pa^*
*
Moisture!removal!filters!for!GastroCH₄ECK®!Gastrolyzer®!pack!of!5!(only!
required!if!using!breath!bags)!filters!last!for!150!tests!or!3!mo n ths.!
Q+9-3/!R4!TP!+^PT.-*
*
34*ltr!calibration!kit!-!100ppm!Hydrogen,!100ppm!Methane,!20.9%!Air!
with!regulator.!
Q+9-3/!R4!TP!+^*
34*ltr!replacement!canister!100ppm!Hydrogen,!100ppm!Methane,!20.9%!
Air.!
Q+9-3/!R4!TP
!+^.+'+2*
Calibration!adapter!for!GastroCH₄ECK®!Gastrolyzer®.!
34QC[b^PY*
1!ltr!Regulator!for!use!with!34*!&!112!ltr!cylinders.!
N.24PY*
Pack!of!50!wipes.!
.99+PLL*
Face!mask!sampling!system!for!use!with!GastroCH₄ECK®!Gastrolyzer®!
breath!bags.!
-49-P^+!-/94*
Home!care!breath!testing!kit!for!lactose!intolerance.!Substrate!not!
included.!
-49-PM3,!-/94*
Home!care!breath!testing!kit!for!fructose!intolerance.!Substrate!not!
included.!
-49-P^+!-,^/94*
*
Home!care!breath!testing!kit!for!small!intestinal!bacterial!overgrowth!
(SIBO).!Substrate!not!included.!
!
Bedfont® Scientic Ltd.
Station Road, Harrietsham, Maidstone,
Kent, ME17 1JA England
Tel: +44 (0)1622 851122 Fax: +44 (0)1622 854860
Email: ask@bedfont.com
www.bedfont.com
Issue 3- March 2017, 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 2017
Contact Bedfont® or one of our worldwide Gastrolyzer®
distributors for a free demonstration.
www.bedfont.com
Tel:+44 (0)1622 851122
Email: ask@bedfont.com
A full list of our worldwide distributors can be found at
http://www.bedfont.com/distributors/
Our family, innovang health, for yours.
est. 1976
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