Product Safety Compliance; Electromagnetic Compatibility - Stryker SYSTEM G Manual Del Usuario

EN

Product Safety Compliance

International Electrotechnical Commission (IEC)
IEC 60601-1 A1: R:2012 (3.1 Edition): Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and
Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); Amendment 1 (2012)
IEC 60601-1-6: 2013: USABILITY – Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral standard: Usability – Edition 3.1 Consolidated Reprint.
IEC 62366: 2014: USABILITY – Medical devices – Application of usability engineering to medical devices - Edition 1.1
Consolidated Reprint.
IEC 60601-1-2: 2010: EMC (Version 3.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 3.0
IEC 62133: 2012/12/06 Edition: 2.0: Secondary Cells and Batteries Containing Alkaline or other Non-Acid Electrolytes
– Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for use in Portable
Applications, Corrigendum 1:2013
European Committee for Electrotechnical Standardization (CENELEC)
EN 60601-1:2006/A1:2013 (3.1 Edition): Medical electrical equipment Part 1: General requirements for basic safety and
essential performance – Incorporates Amendment A12: 2014

Electromagnetic Compatibility

The STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) is intended for use in the electromagnetic environment specified below. The customer or the
user of the STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) should assure that it is used in such an environment.
Emissions test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
10
Guidance and manufacturer's declaration - electromagnetic emissions
The STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic
The STRYKER SYSTEM G Sagittal Saw (REF 7308-001-000) is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-voltage power supply network that
N/A
N/A
Electromagnetic environment - guidance
equipment.
supplies buildings used for domestic purposes.
7308-001-700 Rev-A
www.stryker.com