Daum electronic ergo_bike medical8, Operating Instruction

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Safety Notes
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Using the Device in Compliance with the Recommendations
The ergometers of the ergo_bike medical8 series may be used exclusively for
ergometry, cardiovascular rehabilitation and for kinesitherapy.
Their use is only allowed in compliance with the directions of the operating
instructions.
The manufacturer will not be held liable if the ergometer is not used in compliance
with the provided instructions and consequently causes injury to persons or
other severe consequences, as well as material damages.
The ergo_bike medical8 carries the CE label CE 0297 according to the council’s
directive for medical products 93/42 EEC and complies with the basic requirements
of appendix 1 of this directive.
The CE label covers only the accessories included in the package.
Every user of this device and everyone who is concerned with assembling,
maintaining, testing or troubleshooting it, must read and understand the contents
of this operating instructions before starting to work on the device.
The quality assurance system used at daum electronic gmbh complies with the
DIN EN ISO 13485:2003 standard.
The ergo_bike medical8 are designed according to the MPG, group IIa and
comply with the corresponding type B, according to DIN EN 60601-1:1996.
The devices comply to the safety and health requirements according to:
93/42/EEC of the council of June 14, 1993 about medical products,
DIN EN 60601-1-2:2001 (EU directive about electromagnetic compatibility).
daum electronic gmbh considers itself to be liable for the safety, reliability and
functionality of the device only if:
- Modifications and repairs to the device are carried out by daum electronic
gmbh or by a service provider formally authorised by daum electronic gmbh
to do this work.
- the device is used in compliance with the directions of the operating instructions.
Personnel (Staff)
The ergo_bike medical8 may only by operated by educated personnel (staff).
The personnel must read and understand this operating instructions before
operating the device.
The operating instructions must be kept in the direct vicinity of the ergo_bike
medical8.
Patient Safety
According to the prescriptions of the by-law (order) for operating medical products
(MP by-law §5) the users must
- be educated in operating the ergometer.
- master the necessary sequences for handling and assembling the device.
- know the applicable safety regulations for operating this type of devices, and
act accordingly.
- know about any additional regulations that may apply (e.g. safety facilities).
- know about possible risks (hazards) that may arise from using this type of
devices.
In order to maintain the safety of the patients, it must be avoided that conductive
parts and the connectors connected to them, including the neutral electrode,
come into contact with others conductive parts (including the grounding), while
getting on the ergo_bike medical8.
Please do never touch device parts conducting very low safety voltage and the
patient simultaneously.
When coupling with other devices or with a combination of medical systems
care must be taken to prevent any danger arising from the summation of the
leakage currents. If you have any questions please ask your dealer or the service
department of daum electronic gmbh. In particular, when coupling many devices
to a test site care must be taken to ensure that the potential equalisation is
effected through a common power supply (e.g. a wall socket-outlet).
If a socket with multiple outlets is installed after the initial start-up, no other
device may be connected to this socket. (use covers on the multiple sockets)
An electrical shock hazard exists when touching non-medical devices, and
devices that are not separately grounded.
Defective or faulty devices and accessories may not be used.
The personal computer and all other connected non-medical devices (e.g.
monitor, printer, etc) must be installed at least 1.5m away from the patient place,
because leakage currents could be generated on the housing (or use separate
grounding, housing leakage current).
Patient Treatment
All the devices and the related components and parts must every time be
checked for functionality and defects before they are used with the patient.
Notes From the Manufacturer to the User
The device is not protected against the infiltration of liquids.
Direct contact with humidity or liquids must absolutely be avoided.
Care must be taken to wipe out sweat drops after training (sweat attacks paint
and plastic parts)
Damages caused by sweat are not covered by the warranty.
The ergometer should be installed on a level, firm floor (e.g. concrete
floors). For other floor surfaces we recommend to use the device over a
protective underlay. Appropriate underlays for the protection of the floor
can be ordered from daum electronic gmbh.
The manufacturer will not be held liable for damages to the floor.
Order No. 0810401
Accessories
The device may only be used with the accessories prescribed and distributed
by daum electronic gmbh.
Every accessory item and every device connected must be manufactured in
conformity with the corresponding standard, e.g. DIN EN 60950 for computer
devices, DIN EN 60601-1 for electromedical devices.
Software
The supplied software may only be copied and archived for safety and functional
reasons. In special cases a request must be addressed in writing to daum
electronic gmbh. Releasing it to non-authorised persons in not allowed. The
ergo-bike medical8 may only be used with the internal and external softwares
supplied and authorised by daum electronic gmbh.
Documentation
The documentation supplied is an integral part of the ergo_bike medical8 and
may only be copied or distributed with the authorisation of daum electronic
gmbh.
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