Stryker Flyte Manual Del Usuario página 8

EN
Specifications
Model: REF 0408-600-000
Description: Flyte Helmet
European
Conformity:
0.47 kg [16.6 oz]
Mass:
Fiber-optic Not Applicable
Cable Length:
Fan Speed: 2,250 - 3,500 rpm
Input Voltage: 6 - 8.4 V
Ingress IPX0
Protection (IP):
Continuous
Mode of
Operation:
Product Safety
Certification:
CSA International
International Electrotechnical Commission (IEC)
IEC 60601-1:2012, Ed: 3.1, 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 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment — Part 1-6: General Requirements for Basic Safety and Essential
Performance - Usability
IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices
Canadian Standards Association (CSA)
CAN/CSA-C22.2 No. 60601-1:2014, Medical Electrical Equipment — Part 1: General Requirements for Basic Safety and Essential Performance;
(IEC 60601-1:2005+A1:2012, MOD)
American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)
ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment — Part 1: General Requirements for Basic Safety and Essential
Performance; Consolidated Reprint (2009)/(R) 2012; Amendment 2 (2010/(R) 2012); Amendment 1 (2012)
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)
Environmental
Conditions:
Temperature
Limitation
Humidity
Limitation
Atmospheric
Pressure
Limitation
8
REF 0408-635-000
Flyte Helmet with Fiber-optic Headlight
Not Applicable
0.68 kg [24.0 oz]
3.05 m [10 ft]
Operation
REF 0408-645-000
Flyte Helmet with Battery-powered Headlight
0.52 kg [18.3 oz]
Not Applicable
Storage and Transportation
0408-600-705 Rev-AB
www.stryker.com