Unpacking And Inspection; Introduction; Definitions; Indications For Use - Cantel Medical MEDIVATORS ENDO STRATUS EGA-501 Instruction Manual

Gi endoscopy co2 insufflator
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I. Unpacking and Inspection:
Upon receiving the ENDO STRATUS
shipping box:
Base tray and water bottle holder
Hardware for assembling water bottle holder
Operator's manual
Power cord
READ THIS MANUAL THOROUGHLY BEFORE PROCEEDING WITH THE
OPERATION OF THIS EQUIPMENT.
The user manual is written at a level such that it can be understood by the intended users and is
consistent with the education and training of users. These instructions should be stored and used for
reference as needed. If there are any questions, please contact Customer Service - Service Department
at 800-444-4729 / International: 01-782-594164
II. Introduction:

Definitions:

Throughout this document the ENDO STRATUS CO
or "device"
L/min – Liters per minute (flow)
kPa – kilo Pascal (pressure)
VAC – Volts Alternating Current (electrical potential)
W – Watts
Hz – Hertz (frequency)
PSI – Pounds Per Square Inch (pressure)

Indications for Use:

The ENDO STRATUS CO
when used in conjunction with a gastrointestinal endoscope.
The ENDO STRATUS CO
control delivery of CO

Contraindications:

The ENDO STRATUS CO
rienced in the standard practices of gastrointestinal endoscopy procedures. It should only be used for proce-
dures where insufflation of the gastrointestinal tract is necessary to support navigation of the GI endoscope and
performance of any necessary evaluation procedures. The device should not be used in any other method or
for any other treatments or procedures.
The device is contraindicated for laparoscopic or hysteroscopic insufflation. It must not be used for intrauterine
distension.
The device is contraindicated for CT colonography. Also, the device is not intended for use with or exposure to
magnetic resonance imaging (MRI) systems. Do not use the device in an environment where it could be
exposed to MRI systems.
INTERNATIONAL_ IFU-52 (CO2 INSUFLATOR PUMP) REV H .indd 3
Instruction Manual
CO
insufflator, ensure that the following items are included in the
®
2
insufflator is designed to use CO
2
insufflator contains a CO
2
to the patient that has been warmed to a target temperature 37°C.
2
insufflator should only be used by or under the direct guidance of a physician expe-
2
insufflator may be referred to as "unit"
2
as a distention media in the gastrointestinal tract
2
warming feature that allows the clinician to modulate and
2
3
IFU-52/ REV H
12/11/2015 9:31:54 AM

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