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Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare
2.2.3.2 Heat Output
Device
PC
Monitor
Printer
TAKE ANY STEPS NECESSARY TO PROVIDE CORRECT TEMPERATURE AND
DUST FREE ENVIRONMENT FOR CORRECT OPERATION OF PC IN THE CONTROL
ROOM.
2.3 Equipment Classifications
The following equipment classifications are applicable to the product:
Table 3-6:
Classification category
Protection against electric shock
Degree of protection against electric shock
Degree of protection against harmful ingress of water.
Method(s) of sterilization or disinfection recommended by the
manufacturer.
Degree of safety of application in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
Mode of operation
2.4 IEC60601–1–2 Electromagnetic Standard Compliance & Documentation
The information contained in this section is also found in the Innova system Operator Manual.
2.4.1 General Scope
This equipment complies with IEC60601–1–2 Edition 2 EMC standard for medical devices
The Innova system is suitable to be used in the electromagnetic environment, as per the
limits & recommendations described in the tables here after:
•
Emission Compliance level & limits (
•
Immunity Compliance level & recommendations to maintain equipment clinical utility
(see
NOTE:
This system complies with above–mentioned EMC standard when used with supplied cables
up to maximum lengths referenced in the MIS MAPS or system cables interconnect diagrams.
Chapter 3 Physical Requirements of Room
Control room
Control room
Control room
Table 3-8
,
Table 3-9
Location
Class I
Type B
Ordinary equipment (enclosed equipment without protection against
ingress of water); except footswitch which is a watertight device
(protected against the effects of submersion, IPX7).
Sterilization: not applicable
Disinfection: refer to operator manual (Chapter Safety and Regulatory
section Disinfection), recommended disinfecting agents.
Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide
Continuous operation with intermittent loading
Table 3-7
and
Table 3-10
).
Direction 5314528-2-1EN, Revision 1
Heat output
335W – 1206 BTU/h
125W – 427 BTU/h
67W – 229 BTU/h (idle)
Equipment classification
).
51
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