Actiwatch Guide to Getting Started 7.2 (July 2009)
Regulatory Information - CE Notice (European Union)
The Actiwatch is a Class I Medical Device conforming to the
essential safety & health requirements and provisions of EC
Council Directives 93/42/EEC, Annex I and VII.
Manufacturer:
Applicable Standards:
E60601-1:2001
Medical electrical equipment – General requirements for safety.
E60601-1-2:2002
Medical electrical equipment – Part 1-2: General requirements
for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests.
Group 1 equipment / Class B – (emissions only)
E60601-1-2:2002
Medical electrical equipment – Part 1-2: General requirements
for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests.
Non life supporting equipment (immunity section only)
E60601-1-4:1997
Medical electrical equipment – Part 1-4: General requirements
for safety – Collateral standard:
General requirements for programmable electrical medical
systems.
Actiwatch - Medical
Device Information:
CamNtech Ltd
Upper Pendrill Court
Papworth Everard
Cambridgeshire
CB23 3UY, UK
Waste Electrical & Electronic Equipment (WEEE) The EU requires, under the
Waste Electrical and Electronic Equipment Directive 2002/96/EC, that
manufacturers and/or distributors of Electronic and/or Electrical Equipment
manage and pay for the collection and further handling of WEEE products, as
well as provide WEEE-related information to their customers.
CamNtech has taken the following approach to complying with this Directive:
• CamNtech has registered with an approved producer compliance
scheme (PCS) in accordance with the requirements of the WEEE
Directive.
• CamNtech will provide free recycling for all of its WEEE products when
returned.
• CamNtech WEEE products will be designed with recycling, reuse and
waste management as a consideration.
• CamNtech WEEE products will be labeled or stamped with the WEEE
marking in accordance with European Standard EN 50419.
