US endoscopy 710302, Руководство оператора

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CO
2
EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual
Page 6
Section 4.0 WARNINGS AND CAUTIONS
This section describes warning and caution information for safe operation of the
CO
2
EFFICIENT ENDOSCOPIC INSUFFLATOR. All information in this manual,
and particularly in this section, should be read thoroughly and understood before
using the device.
4.1 WARNINGS
•
Excessive absorption of CO
2
results from over insufflation. The GI Tract can be
adequately distended by the physician’s modulation of the air/water valve.
•
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.
•
Idiosyncratic reactions: In patients with sickle cell disease or pulmonary
insufficiency, use of these devices may pose increased risks of respiratory acidosis
related to excessive CO
2
absorption.
•
Use only USP “Medical Grade” CO
2
available in “D” or “E” supply tanks.
•
Tubing set is to be changed following standards and guidelines set forth by SGNA
and APIC for reprocessing of water bottles used during Gastrointestinal Endoscopy.
•
Using unauthorized, non-US Endoscopy brand tubing sets will void the warranty. US
Endoscopy cannot assume any risk related to the use of non-US Endoscopy brand
product
.
•
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 electrical 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 device should be operated only by or under the direct supervision of a licensed
physician experienced in Gastrointestinal Endoscopy. 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 endoscopic system. 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 properly wired
grounding receptacle only.
•
To prevent unit contamination, use only CO
2
Endoscopic Tubing Set which includes
a ≤0.1 micron hydrophobic filter.
•
Always instruct the patient to immediately notify the operator of any pain
experienced during the procedure.