GE Innova IGS 520, Руководство по предварительной установке

Страница: 24 / 244

2.2 Equipment Classifications
The following equipment classifications are applicable to the product:
Classification category Equipment classification
Protection against electric shock Class I
WARNING
TO AVOID THE RISK OF ELECTRIC
SHOCK, THIS EQUIPMENT MUST ONLY
BE CONNECTED TO A SUPPLY MAINS
WITH PROTECTIVE EARTH.
Degree of protection against electric shock
Type B applied parts
Applied parts complying with the specified requirements of the
IEC 60601-1 standard to provide protection against electric
shock, particularly regarding allowable patient leakage current
and patient auxiliary current include:
• Mattress
•
Table accessories: shoulder rest, foot rest, table head ex‐
tender, Removable rails (sleeve), Head widener with pad/
cushion, Width extender with pad/cushion, armboard with
thick pad/cushion, rail extender and patient restraint strap
with cushion.
Degree of protection against harmful ingress of water Ordinary equipment (enclosed equipment without protection
against ingress of water); except footswitch which is a watertight
device (protected against the effects of submersion, IPX7/IPX8)
Systems with OR Table: Table, TSSC, Smart Box, Table Pan‐
ning Device and Innova Central touch screen are watertight de‐
vices protected against the effects of splashing (IPX4). Foot‐
switch is a watertight device protected against the effect of sub‐
mersion (IPX8).
Method(s) of sterilization or disinfection recommended by the
manufacturer
•
Sterilization: not applicable
• Disinfection: refer to Operator Manual (Chapter Safety and
Regulatory, section Disinfection), Recommended disinfect‐
ing agents.The system does not fulfill the requirements for
AP/APG classification (IEC 60601-1).
Degree of safety of application in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide
Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide
Mode of operation Continuous operation with intermittent loading
The VIVID E9 ultrasound unit is a Class I device, type CF, according to Sub-clause 14 of
IEC60601-1 (1988).
For further details please refer
VIVID E9 Service Manual GA091568TPH
Table 1-17
NOTICE
The system can only be installed in an anesthetizing location if that location is
classified as Other Than Hazardous as per NFPA 70 clause 517.60
Innova
TM
IGS 520, Innova
TM
IGS 530, Innova
TM
IGS 540 Pre-Installation Manual
Direction 5499972-1-1EN, Revision 2
24 2 Customer Responsibilities