EZ EM PROTOCO2L 6400 - Cautions; DESCRIPTION OF EQUIPMENT; Specifications; Electrical Requirements

PROTOCO
2
L
TM
Colon Insufflator User Manual
Page
7

Always instruct the patient to immediately notify the operator of any pain
experienced during the procedure.

If an eme
rgency should arise whereby the need to terminate insufflation is required,
operators should stop the gas flow by promptly disconnecting the PROTOCO
2
L™
Administration Set at the Insufflator Output Port.

The PROTOCO
2
L™ Colon Insufflator can release CO
2
to the surrounding
atmosphere in the event of misuse or a fault condition. Use and store the
PROTOCO
2
L™ Colon Insufflator in a well ventilated environmen
t. Additionally,
make sure all CO
2
supply tank connections are correctly installed and free of visible
damage. Should an unexplained rapid discharge of CO
2
occur, evacuate the
immediate area until it has had sufficient time to ventilate.

High Pressure USP
CO
2
is supplied to the PROTOCO
2
L™ Colon Insufflator from
commercially available CO
2
supply tanks. Please read and carefully follow all
Warnings, Cautions and Handling Instructions provided with, and listed on these
CO
2
supply tanks that are used with the PROTOCO
2
L™ Colon Insufflator. Fa
ilure to
do so can result in Serious Injury or Death.

This product contains phthalates which have been perceived as having possible
carcinogenic, mutagenic and reproductive risks. However, based on all existing
scientific data, the long history of safe u
se of medical device products containing
phthalates, as well as the short duration of contact with this device, there are no
known cancer or reproductive risks to humans. Physician discretion is required to
ensure that benefits outweigh risks when this dev
ice is used in children, elderly and
pregnant women.
4.2
CAUTIONS

Do not allow fluids to enter the device.

The cabinet should not be opened except by a qualified service person. Tampering
by unqualified persons can damage the unit and void the warranty.

Verify
proper connection of tubing before using the unit.

This device has not been tested for MR compatibility, and should not be introduced
into the MR exam room.

Do
Not
attempt to use this system until you have completed all the steps in
“Assembly Prior to Col
on Insufflation” Section 9.0 and “Setting
-
Up for the
Procedure” Section 10.0. If the equipment differs significantly in appearance or
operation from the way it is presented in this manual, or you have any doubts what
-
so
-
ever concerning its installation or
operation, inform E
-
Z
-
EM, Inc. Customer
Solutions at 1
-
800
-
544
-
4624 (USA), 1
-
516
-
333
-
8230.