Gastrolyzer Gastro CH4ECK - Definitions; Intended Use

!
!
2!
!
!
GastroCH
4
ECK
TM
Gastrolyzer®
!
Definitions'
CAUTION'indicates!a !po t en t ially !h az a rd o us !s itu at io n ,!w h ich ,!if!n o t!a vo id e d ,!m a y !res 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).!!
IMPO R T A N T !is!used!for!com 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 !ca ll!a tte n tio n !to !n o ta b le !in fo rmation!that!sho u ld !b e!f o llowed!during!inst alla t ion,!
use,!or!servicing!of!this!equipment!
!
Intende d 'U s e '
The!GastroCH₄ECK™!Gastrolyzer®!is!a!portable!desktop!monitor!which!measures!Hydrogen!(H
2
),!
Methane!(CH
4
)!and!Oxygen !(O
2
)!levels!in!expired!bre ath !sam p les !in!resp on 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 !mouthp iece!
or!a!sample!can!be!taken!remotely!via!a!breath-bag!for!subsequent!analysis.!
The!GastroCH
4
ECK™!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!perform ed.!
The!GastroCH
4
ECK™!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!!
!
!
!
!
!