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EZ EM PROTOCO2L 6400 - WARNINGS AND CAUTIONS; Warnings

EZ EM PROTOCO2L 6400
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PROTOCO
2
L
Colon Insufflator User Manual
Page
6
Section 4.0
WARNINGS AND CAUTIONS
This section describes warning and caution information for safe operation of the
PROTOCO
2
L Colon Insufflator. All information in this manual, and particularly
in this section,
should be read thoroughly and understood before using the device.
4.1
WARNINGS
If pneumoperitoneum (free intra
-
peritoneal air) is observed, or if colonic perforation
is suspected at any time during the use of PROTOCO
2
L insufflator, immediately
discontinue use
and provide appropriate medical treatment.
Prior to use, be sure to read all instructions for use on the PROTOCO
2
L
Administration Set.
Excessive absorption of CO
2
results from either excessive flow rate and/or excessive
pressure. The colon can be adequat
ely distended by pressure in the range of 15 to
25
mm Hg. Use of pressure less than or equal to 25 mm Hg will dramatically reduce
the likelihood of intravasation of CO
2
gas into open vascular channels. Also,
adequate respiration helps avoid problems relat
ed to CO
2
.
Should accidental intravasion of CO
2
occur, in rare circumstances, it can result in
embolization.
Infusion of CO
2
can result in carbonic acid irritation to directly contacted tissues.
Use only USP “Medical Grade” CO
2
available in “D/E” supply ta
nks
Equipment is not suitable for use in the presence of a flammable anesthetic mixture
with air, oxygen, or nitrous oxide.
Never attempt to service the device when it is connected to a power source.
Hazardous voltages inside the device can cause severe e
lectrical shock. Disconnect
the power cord before servicing.
Ensure that all high
-
pressure gas line connections are secure before opening the gas
source(s). Loose connections could separate unexpectedly with great force, causing
personal injury.
This devic
e should be operated only by or under the direct supervision of a licensed
physician experienced in colon insufflation. The user should be thoroughly familiar
with the operation of this device prior to use. Additionally, individuals using this
device must
be alert and attentive to the operation of the system while it is connected
to the patient. Diligence on the part of the operator is an essential requirement of
overall device safety.
To avoid the risk of electrical shock, connect the power cord to a prop
erly wired
grounding receptacle only.
To prevent unit contamination and patient cross
-
contamination, use only E
-
Z
-
EM’s
PROTOCO
2
L Administration Set which includes a 0.1 micron hydrophobic filter.
Idiosyncratic reactions: In patients with sickle cell dise
ase or pulmonary
insufficiency, use of these devices may pose increased risks of metabolic imbalance
related to excessive CO
2
absorption.