Safety And Maintenance - Zimmer CITrac Instructions For Use Manual

Safety and Maintenance

The clTrac is manufactured according to the safety regulations of DIN EN 60601-1.
As manufacturer, Zimmer MedizinSysteme GmbH can only be considered
responsible for the safety and reliability if:
- the device is operated using a proper power outlet that is properly grounded and
the electrical installation complies with DIN VDE 0100 part 710,
- the equipment is operated in accordance with the instructions for use,
- extensions, readjustments, or modifications are carried out only by persons
authorized by Zimmer MedizinSysteme GmbH
- the user is satisfied regarding the functional safety, the proper condition and
mechanical integrity prior to using of the device,
- the device is operated only by properly trained personnel,
- the device is not operated in hazardous areas and / or a combustive atmosphere,
- the device is immediately disconnected from the mains in the event of the
penetration of liquids. The device does not contain any parts that can be serviced or
repaired by the operator.
Zimmer MedizinSysteme GmbH will make available on request circuit diagrams,
component part lists, descriptions, calibration instructions, or other information that
will assist service personnel to repair those parts of the device that are designated
by Zimmer MedizinSysteme GmbH as repairable by service personnel.
Basic safety Basic safety in the context of this document is defined as any situation that can
occur that is harmful for the patient.
In order to achieve basic safety, the clTrac has the following hardware safety
measures:
• Physical: Max force motor 107 kg
• Electrical: Electrical isolation
Essential performance Essential performance for safety of the clTrac in the context of this document is
defined as:
The device is operational, and the applied force shall not exceed 20% of the target
force as set by the operator.
In order to achieve its essential performance, the clTrac needs to apply specific
force onto a traction cord. The applied force is set by the operator by means of the
touch screen and rotary knob.
When essential performance is lost there are several electronic checks which will
remove power to the motor. This will stop the movement and friction will be the only
force left on the traction cord. The registered force is shown on the screen, but by
design can never be more than 107 kg.
Software update Turn on the clTrac
Insert the USB with the new updated software
A pop-up will ask you if you confirm the new software update.
After completing the software, you can erase the USB from the clTrac and restart
the device.
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