Instructions for Use
XLTEK Protektor32
14
Protektor32 Safety and Standards Conformity
Essential Performance
The potential sources of unacceptable risk identified to characterize the ESSENTIAL PERFORMANCE of
EMG DIAGNOSTIC EQUIPMENT are:
•
Minimum noise on a waveform or artifacts or distortion in an image and any error of a displayed
numerical value which cannot be attributed to a physiological effect and which may alter the
diagnosis
•
Free from the display of incorrect safety-related indications
•
Free from the production of unintended or excessive stimulation output
•
Free from the production of unintended or excessive patient applied parts surface temperature
Standards Compliance and Normative References Information
Intraoperative Neuromonitoring device, Model
Protektor32
, transportable / mobile (when mounted on
cart), rated: 24Vdc, 2A. For use with external power supply (Jerome Industries; model WSL524MC; rated
100~240Vac, 50/60Hz, 140VA; Xltek P/N 005307)
1. Type of protection against electric shock: Class I
2. Degree of protection against electric shock: Type BF
3. Degree of protection against ingress of water: IPX0
4. Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with
oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous oxide.
5. Mode of operation: Continuous
6. Environmental Conditions: Normal: 10-40°C, 30-75% rH, 700-1060hPa
The
Protektor32
and its accessories have been designed to comply with the following national and
international standards.
Table 1 – Safety Standard of Compliance and Normative References
IEC 60601-1:2012 (Ed. 3.1)
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance Includes national
deviations as shown below.
ANSI / AAMI ES 60601-1:2005 +
A1:2012
Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
CSA C22.2 No. 60601-1:2014-03
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
EN 60601-1:2006 + A1:2013
Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
IEC 60601-2-40:1998 (Ed. 1.0)
Medical electrical equipment - Part 2-40: Particular
requirements for the safety of electromyographs and evoked
response equipment
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