GE eBike BASIC - Leakage Currents; Inspection According to German Medical Device Operator Ordinance; Technical Safety Inspections and Inspections of the Measuring Systems

2018112-069 Rev. F eBike II, eBike II L, eBike II EL - 11 -
Hint
• §11 of the German Medical Device Operator Ordinance
demands that ergometers used in medicine, i.e. ergome-
ters for exercising patients with a dened and reprodu-
cible physical load, be calibrated with a dynamic load.
leakage Currents
MeasurIng equIpMent
The measuring equipment used for the electrical safety
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.
eBIke II BasIC / CoMfort
The eBike II basic/comfort ergometers are protection
class II equipment (no connection to protective ground).
The necessary electrical safety tests for these devices
together with the limit values are listed in the chapter
„eBike II basic/comfort - Preventive maintanance“.
eBIke II l / el
The eBike II L / EL supine ergometers are protection
class I equipment (with connection to protective ground).
The necessary electrical safety tests for these devices
together with the limit values are listed in the chapter
„eBike II L - Preventive maintanance“ and
„eBike II EL - Preventive maintanance“.
InspeCtIon aCCordIng to gerMan MedICal
d
evICe operator ordInanCe
teCHnICal safety InspeCtIons and InspeCtIons of tHe
MeasurIng systeMs
According to §6 and §11 of the German Medical Device
Operator Ordinance, the load unit must be inspected to
the approved rules of the art at intervals of 2 years by an
GE Medical Systems InformationTechnologies authorized
service technician, and repaired if necessary.
Static and dynamic inspections of the ergometer must be
performed according to DIN VDE 0750-238.
Calibration instructions for the NIBP module can be found
in this Service manual. Follow these instructions to display
the BP values with the test setup according to
DIN EN 1060-1 and DIN EN1060-3.
The measurement results must be documented in the
medical device book..
According to the German Medical Device Operator
Ordinance, the next due inspection is indicated on the Test
Sticker next to the ergometer’s nameplate.