CME BodyGuard 595 Color Vision - Operating Conditions

6 – Specifications
BodyGuard 595™Color Vision Operator Manual
66
Classification
Type CF Equipment (degree of protection against electrical
shock)
Housing:
ABS (fire retardant)
Weight
 280 grams without battery
 390 grams with battery
Electrical Safety
Complies with: EN 60601-1 (Medical Electrical Equipment
Safety), IEC 60601-2-24 (Infusion pumps and controllers), IEC
60601-1-4 (Programmable Electrical Medical System)
Standards
Manufactured in accordance to ISO 9001:2008 and ISO
13485:2003 . CE marked (In accordance with the Medical
Devices Directive 93/42/EEC)
EMC
The BodyGuard 595 Color Vision™ Pain Manager is designed to
be in compliance with EN 60601-1 (safety) and IEC 601-1-2
(EMC).
Environmental
Specifications
Non Operating Conditions (Transportation and Storage):
Temperature: -25
o
C to 50
o
C (-13
o
F to + 122
o
F)
Humidity: 5 % to 100% R.H., non-condensing
Air pressure: 48kPa to 110kPa
Operating Conditions:
(The system may not meet all performance specifications if
operated outside of the following conditions)
Temperature: +18
o
C to +45
o
C (+59
o
F to + 113
o
F)
Humidity: 20 % to 90% R.H. at +40
o
C, non-condensing
Air pressure: 70kPa to 110kPa
Administration set
Dedicated administration sets with anti-siphon valve.