Use Instructions
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Latex
These products do not contain natural latex rubber or dry natural rubber in user or
operator accessible areas.
Passing the product on to another user (excludes GoSafe
Mobile Button)
This product cannot be passed to another user by an existing user. In the event an
existing user wishes to end their service, they must return the devices to Philips Lifeline
or their representative.
Technical Specications
Standards Compliance
This device is designed to conform to the following standards:
• IEC/ANSI/ AAMI60601-1:2005/R(12)2012, 3rd edition, Part 1 – General requirements
for basic safety and essential performance.
• CSA C22.2 # 60601-1:2014 Ed.3 Medical Electrical Equipment – Part 1: General
Requirements For Basic Safety And Essential Performance.
• IEC/UL/CSA 60601-1, 2nd Edition (2003), `Medical Electrical Equipment, Part 1:
General Requirements for Safety’ (except for 7100MHB).
• IEC 62133, Safety requirements for portable sealed secondary cells, and for
batteries made from them, for use in portable applications.
• IEC 60601-1-2, 3rd Edition (2007-03), General requirements for safety – Collateral
standard: Electromagnetic compatibility - Requirements and tests
• IEC 60601-1-2, 4th Edition (2014) medical Electrical Equipment – Part 1-2: General
requirements for basic safety and essential performance – Collateral standard:
Electromagnetic compatibility – Requirements and tests (7200C model only)
• IEC 60601-1-4, 2nd Edition (2000), `Collateral standard: Programmable Electrical
Medical Systems’ (except for 7100MHB)
• IEC 62366, 1st Edition (2015), `Medical devices – Application of usability engineering
to medical devices’
• IEC 60601-1-6, 2nd Edition (2004), `Collateral standard: Usability’ (except for
7100MHB)
• IEC 60601-1-6, 3rd Edition (2013), `Collateral standard: Usability’
Agency Submission File