User's Manual

28 www.stryker.com
EN 5400-052-700-EN Rev-D
Product Safety Compliance: International Electrotechnical Commission (IEC)
IEC 60601-1:2005, Ed: 3.1, Medical Electrical Equipment — Part 1: General Requirements
for Basic Safety and Essential Performance; Corrigendum 1 (2006); Corrigendum 2 (2007);
Amendment 1 (2012)
IEC 60601-1-2:2007 Ed: 3, Medical Electrical Equipment – Part 1-2: General Requirements for
Basic Safety and Essential Performance – Electromagnetic Compatibility
IEC 60601-1-2:2014 Ed: 4, Medical Electrical Equipment – Part 1-2: General Requirements for
Basic Safety and Essential Performance – Electromagnetic Disturbances
IEC 60601-1-6:2010+ A1:2013 Ed. 3.1, Medical Electrical Equipment – Part 1-6: General
Requirements for Basic Safety and Essential Performance – Usability
IEC 62366-1:2007+ A1:2014 Ed 1.1, Medical Devices - Part 1: Application of Usability
Engineering to Medical Devices
IEC 62304:2015 Ed: 1.1, Medical Device Software – Software Life Cycle Processes
European Committee for Electrotechnical Standardization (CENELEC)
EN 60601-1:2006+A12:2014, Ed: 3.1, Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC
Corrigendum 2 (2007); CENELEC Corrigendum (2010); CENELEC Amendment A11 (2011);
IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014)
The Regulatory Compliance Mark (RCM) is a visible indication of a product’s
compliance with all applicable ACMA regulatory arrangements, including all
technical and record-keeping requirements.
RFID Module:
Frequency of Operation: 13.56 MHz
RF Field Strength: 67.92 dBµA/m at 3 m
Touch Screen: 7 inch [177.8 mm] (800 x 480), 24-bit color, wide viewing angle: 170°
Adjustable Volume: 0 dBA to 52 dBA
Environmental Conditions: Operation Storage and Transportation
Temperature:
Humidity Limitation:
85 %
10 %
Atmospheric Pressure
Limitation:
0000221359, Rev. D Effective Date: Jun 1, 2017 10:00:55 AM
Print Date: Jun 08, 2017 08:54:46 AM