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e
s
leCtrICal
afety
Warning
• Equipment Damage •
•
The regulations about handling ESD sensitive components
must be observed.
Hint
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.
Warning
• Patient Hazard, Equipment Damage •
•
IEC 60601-1 requirements must be satisfied during repair,
modifications and inspections of medical
electrical equipment.
•
To ensure that equipment functions faultlessly and wit-
hout presenting any hazard after service interventions,
it must be subjected to the test procedures stipulated for
the different device categories.
•
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..
• Patient Hazard, Equipment Damage •
•
Use original spareparts 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.
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eBike II, eBike II L, eBike II EL
2018112-069 Rev. F
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