CPI INDICO 100 Series Operator's Manual page 9

CPI Canada Inc
APPLICABLE STANDARDS
The 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).
ELECTROMAGNETIC COMPATIBILITY (EMC)
In accordance with the intended use, this X-ray generator complies with the European Council Directive
concerning Medical Devices. The CE marking affixed to this product signifies this. One of the harmonized
standards of this Directive defines the permitted levels of electromagnetic emission from this equipment and its
required immunity from the electromagnetic emissions of other devices.
It is not possible, however, to exclude with absolute certainty the possibility that other high frequency electronic
equipment, which is fully compliant to the EMC regulations, will not adversely affect the operation of this generator.
If the other equipment has a comparatively high level of transmission power and is in close proximity to the
generator, these EMC concerns (the risk of interference) may be more pronounced. It is therefore recommended
that the operation of equipment of this type such as mobile telephones, cordless microphones and other similar
mobile radio equipment be restricted from the vicinity of this X-ray generator.
Indico 100 Series Operator Manual
Electrostatic discharge
Radiated RF field
Electrical fast transient
Surge
Conducted RF immunity
Magnetic field immunity
Voltage dips, interrupts and variations
740953-00 Rev. A
Safety and Specifications
Page 9
2