Use Instructions
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• IEC 60601-1-8, 2nd Edition (2006), `Collateral standard: General requirements,
tests and guidance for alarm systems in medical electrical equipment and medical
electrical systems’
• IEC 60601-1-11, 2nd Edition (2015) `Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare
environment’
• ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing
(Biocompatibility)
• ISO 14971, 2nd Edition (2007), `Medical devices – Application of risk management to
medical devices’
• CSA C22.2 No. 205-12 (2012), Signal Equipment(Canada).
• CFR47 FCC Part 15 Subpart B, Sections15.207 & 15.209;
• CFR47 FCC Part 15 Subpart C, Section 15.247.
• CFR47 FCC Part 15 Subpart E.
• RSS-210 Licence – Exempt Radio Apparatus: Category I Equipment
• RSS-247; Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs)
and Licence – Exempt Local Area Network (LE-LAN) Devices.
• RSS-GEN General Requirements for Compliance of Radio Apparatus (Canada)
• ICES 003 Information Technology Equipment (Including Digital Apparatus) – Limits
and Methods of Measurement (Canda)
• CFR47 FCC Part 15 Subpart C, Section 15.249:2012 (7000AHB & 7000PHB)
• CFR47 FCC Part 15 Subpart C, Section 15.249, October 1, 2011 (7200C, 7000MHB,
7100MHB)
• CFR47 FCC Part 68 (7000L)
UL1635, UL1637 and CSA 22.2 No. 205 Compliance
The maximum separation (range) of the equipment, under open eld test conditions
and for comparative purposes only, is 600 feet. This range may be signicantly
reduced when the equipment is installed in a typical home. The 7000MHB and
7100MHB comply to UL1635 and UL 1637 when the GoSafe pendants are within the
range of the communicators with which they are paired.
Agency Submission File