US endoscopy Co2mpact Endoscopic Insufflator, Руководство оператора

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CO
2
MPACT ENDOSCOPIC INSUFFLATOR
®
SYSTEM 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
MPACT ENDOSCOPIC INSUFFLATOR
®
SYSTEM. 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 metabolic imbalance
related to excessive CO
2
absorption.
•
Use only USP “Medical Grade” CO
2
.
•
Tank designations vary by country. Please check with your local distributor for
compatibility.
•
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 tubing sets will void the warranty and US
Endoscopy cannot assume any risk related to the use of non-US Endoscopy products.
•
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, the unit must be grounded. Always connect the
power cord to a properly wired grounded hospital grade AC outlet (wall mains
outlet).
•
To prevent unit contamination, use only US Endoscopy Endoscopic Tubing Sets
which include a ≤0.1
micron hydrophobic filter.
•
Always instruct the patient to immediately notify the operator of any pain
experienced during the procedure.