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5 . 3 LCD and LED Indications
The table below includes the details on all user display messages, it also includes the LED colour, the audible
beeping, and instructions on what actions to take when each message appears. This table may help for
troubleshooting.
5 . 4 Standards Applied
The standards that have been applied to the device are as follows:
• IEC 60601-1-1:2012: Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
• IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• IEC 60601-1-11:2010: General requirements for basic safety and essential performance - Collateral
Standard: Requirements for medical electrical equipment and medical electrical systems used in the
home healthcare environment.
• IEC 62366-1:2015: Medical devices - Part 1: Application of usability engineering to medical devices
• BS EN ISO 14971:2019: Medical devices. Application of risk management to medical devices
• BS EN ISO 12182:2012: Assistive products for persons with disability.
• BS EN ISO 10535:2006: Ceiling Hoists for the transfer of disabled persons. Requirements and test
methods
• Medical Device Regulation 2017/745 - CE marking of Medical Devices
• UK Medical Device Regulation 2002: UKCA marking of medical devices.
• EN ISO 15223-1:2016 - Medical devices. Symbols to be used with medical device labels, labelling and
information to be supplied. General requirements
• EN 1041:2008+A1:2013 - Information supplied by the manufacturer of medical devices.
• BS ISO 20417 – Medical Devices – Information to be supplied by the manufacture.
• Waste Electrical and Electronic Equipment Directive (WEEE) 2012/19/EU.