Controller Classification And Safety Verification; Classification; Safety Verification - smith&nephew ArthroCare Atlas Manuel De L'opérateur

28 ArthroCare
Atlas™ System
®
User's Manual

Controller Classification and Safety Verification

Classification

According to IEC 60601-2-2, Specification for High Frequency Surgical Equipment, the Controller is classified as fol-
lows:
• Type of protection against electrical shock:
Class I equipment.
• Degree of protection against electrical shock:
Defibrillation proof, type BF (Isolating/floating).
• Degree of protection against harmful ingress of water:
- Controller meets requirements of IEC 60601-2-2, subclause 44.6.
- Foot Control meets requirements of IEC 60601-2-2, subclause 44.6, watertight construction (IPX8).
• Equipment not suitable for use in the presence of a flammable anesthetic mixture.
• Mode of operation: capable of continuous operation.

Safety Verification

The ArthroCare Atlas System meets the requirements of IEC 601-1, IEC 60601-2-2. It is recommended that the
biomedical engineering department test the System to ensure that it meets the following leakage levels:
• Leakage current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .≤20µA at 100-240 V~, 50/60 Hz
isolated patient connections
• Leakage current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .≤200µA at 100-240 V~, 50/60 Hz
non patient applied parts
If the System fails to meet the following specifications, please contact ArthroCare Customer Service for a return mer-
chandise authorization.