About The Ocs2; Device Classification; Electrical Safety And Emc - Integra OCS2 Manuel D'utilisation

About the OCS2

Important
Please read this section before operating the Ojemann Cortical Stimulator (OCS2).

Device Classification

Classifications as per UL 60601-1 Ed. 1.0 (2003) describe the Ojemann Cortical
Stimulator (OCS2) as:
Type of protection against electric shock:
Degree of protection against electric shock:
Degree of harmful ingress of liquids:
Mode of operation:
Degree of safety in the presence of flammable
anesthetic mixture with air, oxygen or nitrous
oxide:

Electrical Safety and EMC

The Integra Ojemann Cortical Stimulator (OCS2) and Ojemann Cortical Stimulator Probe
(OCS2PND) have been tested to and meet the requirements of the following:
EN 60601-1 Ed. 2.0 (1990)
CAN/ CSA C22.2 No.601.1-M90
Ed. 2.0 (1990)
IEC 60601-1 Ed. 2.0 (1988)
IEC 60601-1-1 Ed. 2.0 (2000)
IEC 60601-1-2 Ed. 2.1 (2001)
IEC CISPR 11 Ed.4 (2003)
Internally Powered
Type BF
Ordinary
Continuous Use
Not Suitable for Use
Medical Electrical Equipment: General
Requirements for Basic Safety + A1 (93) + A2 (95)
Medical Electric Equipment, Part 1: General
Requirements for Safety
Medical Electrical Equipment: General
Requirements for Basic Safety + A1 (91) + A2 (95)
Medical Electrical Equipment: General
Requirements for Safety – Safety Requirements for
Medical Electrical Systems
Medical Electrical Equipment: General
Requirements for Safety – Electromagnetic
Compatibility
Frequency Equipment: Electromagnetic
Disturbance Characteristics – Limits and Methods
of Measurement
OSC2 Operator's Manual
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