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natus XLTEK Protektor32 User Manual

natus XLTEK Protektor32
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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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natus XLTEK Protektor32 Specifications

General IconGeneral
Brandnatus
ModelXLTEK Protektor32
CategoryMedical Equipment
LanguageEnglish

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