2.2.3 IVUS Option
2.2.3.1 Environmental Limitations in Use (room climate)
Table 3-6: IVUS Rev 1
Humidity (non condensing) :
30 - 80 %
Temperature (at 20% Relative Humidity ) :
15 - 32 C
(60 - 90 F)
Altitude (Relative to see level) :
max 3048 m
(max 10000 ft)
Table 3-7: IVUS Rev 2
Humidity (non condensing) :
30 - 80 %
Temperature (at 20% Relative Humidity ) :
5 - 35 C
(41 - 95 F)
Altitude (Relative to see level) :
max 3048 m
(max 10000 ft)
2.2.3.2 Heat Output
Device
Location
Heat output
PC
Control room
335W – 1206 BTU/h
Monitor
Control room
125W – 427 BTU/h
Printer
Control room
67W – 229 BTU/h (idle)
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 3-8:
Classification category
Equipment classification
Protection against electric shock
Class I
Degree of protection against electric shock
Type B
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).
Method(s) of sterilization or disinfection recommended by the man‐
ufacturer.
Sterilization: not applicable
Disinfection: refer to operator manual (Chapter Safety and Regu‐
latory section Disinfection), recommended disinfecting agents.
Degree of safety of application in the presence of a flammable an‐
esthetic mixture with air or with oxygen or nitrous oxide.
Equipment not suitable for use in the presence of a flammable an‐
esthetic mixture with air or with oxygen or nitrous oxide
Mode of operation
Continuous operation with intermittent loading
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Chapter 3 Physical Requirements of Room 59
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