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9
Approvals
The Polaris Vicra System (consisting of a Position Sensor, Model P6, Power Adapter and a Host
USB Converter), qualifies for the following approvals.
Standard
EN60601-1 (1990) Second Edition plus
A1:93, A2:95, A12:93 and Corr:94
CAN/CSA-C22.2 No. 601.1-M90
(R2001)
UL 60601-1, First Edition, dated April 25,
2003.
Standard
CISPR 11/EN55011
FCC Part 15, Class B
IEC60601-1-2:2001
9.1
Optical Radiation Safety
The Polaris Vicra Position Sensor has been assessed against the IEC Standard 60825-1 and the
Euronorm EN60825-1 and found not to pose a potential hazard to the eye under any foreseeable
viewing condition.
Note
The Polaris Vicra System emits IR light that may interfere with IR controlled devices, such as operating room
tables. It is recommended that you test the Polaris Vicra System if you intend to use it in an environment where
other IR controlled devices are in use.
Polaris Vicra User Guide - Revision 2
Table 9-1 Electrical Safety
Description
Medical Electrical Equipment Part I: General
Requirements for Safety
Medical Electrical Equipment Part I: General
Requirements for Safety
Medical Electrical Equipment Part I: General
Requirements for Safety
Table 9-2 Electromagnetic Compatibility
Description
Class B, Group 2, ISM Equipment
Medical Electrical Equipment, Part 1: General Requirements
for Safety—Collateral Standard: Electro-Magnetic
Compatibility - Requirements and Tests.
Approvals
59
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