ArthroCare Quantum RF 12000, Руководство пользователя

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ArthroCare
®
Quantum™ (RF 12000) System and
29
ArthroCare
®
Quantum™ 2 (RF 12000) System
User‟s Manual
Controller Classification and Safety Verification
Classification
According to IEC/EN 60601-2-2, Specification for High Frequency Surgical Equipment, the Controller is
classified as follows:

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/EN 60601-2-2, subclause 44.6.
-
Foot Control meets requirements of IEC/EN 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 Quantum (RF 12000) System and ArthroCare Quantum 2 (RF 12000) meet the
requirements of IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-4, IEC/EN 60601-2-2,
CSA 22.2
No. 601.1,
and IEC/EN 60601-2-18. It is recommended that the biomedical engineering department
test the System to ensure that it meets the following leakage levels:

Leakage current……………………………………………..

100

A at 100-120/220-240 V~, 50/60 Hz
isolated patient connections

Leakage
current…………………………………………….

500

A at 100-120/220-240 V~, 50/60 Hz
non patient applied parts
If the System fails to meet the specifications listed above, please contact ArthroCare Customer Service
for a return merchandise authorization.