Definitions; Introduction; Intended Use; Using The Gastroch 4 Eck® Gastrolyzer® With Gastrochart - Bedfont GastroCH4ECK Gastrolyzer User Manual

Definitions

WARNING: indicates a potentially hazardous situation, which, if not avoided, may result in minor or
moderate injury.
CAUTION: indicates a potentially hazardous situation, which, if not avoided, may result in damage to
the device.
NOTE: used to call attention to notable information that should be followed during use.

Introduction

The User Manual provides instructions on how to operate GastroCH₄ECK® Gastrolyzer® and its
accessories. It contains relevant information about the monitor, its uses and its care, including step-
by-step instructions with screens and illustrations.

Intended Use

The GastroCH ECK® Gastrolyzer® is a portable desktop monitor used to measure Hydrogen (H
4
Methane (CH ) and Oxygen (O
4
of gastrointestinal sugar and nutrient malabsorption.
The GastroCH ECK® Gastrolyzer® is intended for multi-patient use by children and adults, measuring
4
expired breath samples acquired via a breath-bag for remote testing or using the mouthpiece and
sample line.
The GastroCH ECK® Gastrolyzer® analyses a single patient sample at a time, interfacing with a PC to
4
allow a multi-patient sampling protocol to be performed and allowing further analysis of multiple
results by an appropriately qualified healthcare professional.
The GastroCH ECK® Gastrolyzer® can be used as an aid in the screening and diagnosis of the
4
following disorders:
• Carbohydrate Breakdown Deficiency
• Carbohydrate Malabsorption
• Lactose Intolerance
Bacterial Overgrowth
•
• Determination of time of passage through gut
The GastroCH ECK® Gastrolyzer® diagnostic measurements obtained are intended to be reviewed by
4
an appropriately qualified healthcare professional and interpreted in conjunction with relevant
medical factors applicable to the sample provider, as an aid in assessment of appropriate treatment
or an aid to diagnosis of a condition. Specific diagnosis is not possible directly or instantly with this
device; further specific testing and symptom analysis would need to be carried out by a healthcare
) levels in expired breath samples as an aid to screening and diagnosis
2
),
2
4