1A
Introduction
CPI Canada Inc.
Page 1A-6
Rev. E Millenia / Indico 100 Series Service Manual Ch # 740904-00
1A.9.0 REGULATORIES AND DESIGN STANDARDS
1A.9.1 Environmental Specifications
OPERATING
Ambient temperature range
10 to 40
°
C
Relative humidity
30 to 75%
Atmospheric pressure range
500 to 1060 hPa (375 to 795 mm Hg)
TRANSPORT AND STORAGE
Ambient temperature range
-20 to 70
°
C
Relative humidity
10 to 95%, including condensation
Atmospheric pressure range
500 to 1060 hPa (375 to 795 mm Hg)
1A.9.2 Applicable Standards
The Millenia / Indico 100 family of generators complies with the following regulatory requirements and design
standards:
•
FDA Center for Devices & Radiological Health (CDRH) - 21 CFR title 21 subchapter J (USA).
•
Radiation Emitting Devices Act - C34 (Canada).
•
Medical Device Regulations (Canada).
•
EC Directive 93/42/EEC concerning Medical Devices (European Community).
•
IEC 601.1, IEC 601.2.7:1998, CSA 601.1, UL2601.1
-Type of protection against electric shock: Class I equipment.
-Degree of protection against electric shock: Not classified.
-Degree of protection against harmful ingress of water: Ordinary equipment.
-Mode of operation: Continuous operation with intermittent loading (standby - exposure).
-Equipment not suitable for use in presence of a FLAMMABLE ANESTHETIC MIXTURE WITH
AIR OR WITH OXYGEN OR NITROUS OXIDE.
•
IEC 601.1.2
Immunity:
IEC1000-4-2
Electrostatic
discharge
IEC1000-4-3
Radiated
RF
field
IEC1000-4-4
Electrical
fast
transient
IEC1000-4-5
Surge
IEC1000-4-6
Conducted
RF
immunity
IEC1000-4-8
Magnetic
field
immunity
IEC1000-4-11
Voltage dips, interrupts and variations
Emission:
EN55011 (CISPR Publications II Emission Standards, Group 1 Class A).
