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Inspection according to German Medical Device 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 a GE Medical Systems Information
Technologies authorized Service technician, and repaired if necessary.
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.
If unauthorized personnel opens the control terminal, destroying the calibration sticker (production
date), any warranty claim shall become void.
•
Maintenance:
Depending on the application purpose, all clamping levers of the device must be inspected at intervals
of 6 months to check that the thread and tip of the clamping lever are adequately greased. If necessary,
the clamping levers must be greased.
We recommend using a universal high-performance lubricant such as OKS 470.
Note
§11 of the German Medical Device Operator Ordinance demands that ergometers used in
medicine, i.e., ergometers for exercising patients with a defined and reproducible physical load,
be calibrated with a dynamic load.
The technical inspection of the measuring system is not required for ergometers used for training
purposes only and where the tests are not documented. The restricted applicability must be
identified by a suitable marker on the ergometer and it must be documented in the medical
device book.
Automatic Sphygmomanometer
Calibration instructions for the NIBP module can be found in the Servicing Instructions. Follow these
instructions to display the BP values with the test setup according to DIN EN 1060-1 and DIN EN
1060-3.
Ergometer
Static and dynamic inspections of the ergometer must be performed according to DIN VDE 0750-
238.
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A: Safety Information
eBike, eBike L, eBike EL
2018112-003 Rev J
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