9.0 Regulatories And Design Standards; 9.1 Environmental Specifications; 9.2 Applicable Standards - CPI Indico 100 Series Service And Installation Manual

1A
Introduction
1A.9.0 REGULATORIES AND DESIGN STANDARDS
1A.9.1 Environmental Specifications
OPERATING
Ambient temperature range
Relative humidity
Atmospheric pressure range
TRANSPORT AND STORAGE
Ambient temperature range
Relative humidity
Atmospheric pressure range
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
IEC1000-4-3
IEC1000-4-4
IEC1000-4-5
IEC1000-4-6
IEC1000-4-8
IEC1000-4-11
Emission:
EN55011 (CISPR Publications II Emission Standards, Group 1 Class A).
Page 1A-6
10 to 40 °C
30 to 75%
500 to 1060 hPa (375 to 795 mm Hg)
-20 to 70 °C
10 to 95%, including condensation
500 to 1060 hPa (375 to 795 mm Hg)
Electrostatic discharge
Radiated RF field
Electrical fast transient
Surge
Conducted RF immunity
Magnetic field immunity
Voltage dips, interrupts and variations
Rev. E Millenia / Indico 100 Series Service Manual
CPI Canada Inc.
Ch # 740904-00