Use Instructions

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• 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 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

• IEC 62366, 1st Edition (2015), ‘Medical devices – Application of usability engineering

to medical devices’

• IEC 60601-1-6, 3rd Edition (2013), ‘Collateral standard: Usability’

• IEC 60601-1-8, 2.1 Edition (2012), ‘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 Subparts B, C and E. Part 24E and Part 27.

• RSS-102 Issue 5, Radio Frequency (RF) Exposure

• 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).

• RSS-130 Issue 2, Equipment Operating in the Frequency Bands 617-652 MHz, 663-

698 MHz, 698-756 MHz and 777-787 MHz

• RSS-133 Issue 6, 2 GHz Personal Communications Services

• RSS-139 Issue 3, Advanced Wireless Services (AWS) Equipment Operating in the

Bands 1710-1780 MHz and 2110-2180 MHz

• UL 1635:2018 Standard for Digital Alarm Communicator System Units

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