CAPINTEC, INC. CAPTUS
®
4000e
2-10 FUNCTIONAL & TECHNICAL DESCRIPTION July 16
Printer
HP Officejet 6000 Series (or equivalent) Printer (optional)
100-240Vac, 50/60Hz, 1.5A
Regulatory Listings
The CAPTUS
®
4000e has been independently tested and is manufactured in compliance
with the following Standards:
EMC
• IEC 60601-1-2 Ed. 4.0, (2014): Medical Electrical Equipment – Part 1-2:
General requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and tests
Safety
• ANSI/AAMI ES60601-1:2005/A1:2012 Issued: 2012/08/20 Medical electrical
equipment – Part 1: General requirements for basic safety and essential
performance
• CAN/CSA-C22.2 No. 60601-1:14: Third Edition Issued: 2014/03/01 – Medical
electrical equipment – Part 1: General requirements for basic safety and
essential performance
• IEC 60601-1-6 Issued: 2013/10/29 Ed: 3.1 Medical electrical equipment – Part
1-6: General requirements for basic safety and essential performance –
Collateral Standard: Usability
• IEC 62366:2014, Edition 1.1 Issued 2014/01/28 – Medical devices –
Application of usability engineering to medical devices
• IEC 62304:2006, First Edition Issued: 2006/05/09 Medical device software –
Software life cycle processes
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