Technical Description; Regulatory Compliance - Micrel Rhythmic evolution Instructions For Use Manual

12. Technical Description

• Equipment can be modified as described in service manual by trained service personnel
with valid certificate. Appropriate inspection and testing according to service manual, must
be conducted to ensure safe use of the equipment.
• There are no user serviceable parts or user replaceable parts within the pump, except
9V alkaline disposable battery.
All servicing / maintenance should be performed by a qualified service personnel with
reference to the MICREL Service Manual for this product. A comprehensive service
manual containing circuit descriptions, component part list, servicing and testing
information is available on request. It can be ordered from Micrel Medical Devices or
Micrel Medical Devices authorized distributor. Only trained technicians can perform
service / preventive maintenance.

12.1 Regulatory Compliance

Device complies with EN60601-1 Classified as ambulatory type 4 as per EN60601-2-24
Device is classified as Type IIb as per Medical Device
Directive 93/42/EEC
Electrical safety classification for applied part, as per
EN60601-1 and EN 6001-2-24
Complies with EN60601-2-24.
Declaration of Conformity can be available upon request.
90
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Warning
Type llb
CF