Safety Information - GE eBike Service Manual

A-1. Safety Information
Electrical Safety During Service Interventions (IEC 60601-1)
IEC 60601-1 requirements must be satisfied during repair, modifications and inspections of medical
electrical equipment.
Under the regulations of the product liability act, equipment manufacturers must ensure that their
product does not present any hazard to the user in normal use.
The potential hazards must be considered in particular when handling mains operated devices.
To ensure that equipment functions faultlessly and without presenting any hazard after service
interventions, it must be subjected to the test procedures stipulated for the different device categories.
Requirements for Persons stipulated in the German Medical Device Operators Ordinance:
The requirements of §11 section 6, §11 section 5 sentence 1 and §6 section 4 of the MPBetreibV
(German Medical Device Operator Ordinance) must be satisfied.
The regulations about handling ESD sensitive components must be observed.
1. Protection class I equipment (connected to protective earth conductor)
max. resistance of the protective earth conductor
R protective earth conductor
(with connection cable with max. length of 5 m)
max. equivalent enclosure leakage current for portable equipment.
max. equivalent enclosure leakage current
The measuring equipment used for the tests must be inspected and calibrated at regular intervals. As
per the German Medical Device Operator Ordinance, the measurement results must be documented
in the medical device book.
Note
Suitable common ground terminal:
- Bicycle ergometer eBike Basic / Comfort: screw of the levelling device
- Ergometer eBike L/EL: screw head of the protective earth connection between swivelling section
and ergometer base
A device is considered to be unsafe, when
- it cannot be repaired
- the user does not wish to have the device repaired. In this case, the operator must be
informed in writing of the hazard presented by the device. The same remark must be annotated
on the service report and on the service invoice.
Important information for service interventions:
- Use original spare parts only.
- For information about product changes, refer to the manufacturer's original documentation
only.
- Observe the fuses' original ratings, characteristics and Ampere interrupting capacity.
- Parts of the device that ensure its safe operation must be neither damaged nor obviously
unsuitable. This applies to insulation and insulating components in particular.
- Power cords must be visually inspected for signs of damage before connecting them to the
power line.
2018112-003 Rev J
A: Safety Information
eBike, eBike L, eBike EL
0.100 Ohm
0.500 mA
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