V4.0_2021-05-26
PROGNOST XS
Instructions for use
5034-0-0002
6 of 25
General Notes
WARNING!
In order to maintain the set and tested requirements of the 60601 series of
standards, the ME system must not be modified during its actual operating
life.
Mechanical and Electric Warning
WARNING!
All of the movable assemblies and parts of this equipment should be operated
with care. They must be routinely inspected in accordance with the
manufacturer's recommendations contained in the accompanying
documents. Maintenance and service is only to be performed by personnel
authorized by PROTEC GmbH & Co. KG.
Touching live electrical terminals and connections can be deadly.
Do not remove the flexible high-tension cables from the X-ray tube cover or
high-tension generator or open the housing of the X-ray generator.
Protective conductor connections must be provided in compliance with the
national regulations for all components of the equipment.
Failure to comply may result in serious or fatal injuries to present persons.
To the User
NOTE
The user of these accompanying documents is required to carefully read through
and carefully consider the instructions, warnings and cautions contained therein
before starting operation.
Even if you have already operated similar systems, changes in the design,
production and functional routine of the system described here may have been
made, which have a significant influence on the operation.
Assembly and service works on the system described here must be carried out by
authorised and qualified personnel from PROTEC GmbH & Co. KG. Assembly
personnel and other persons who are not employees of the technical service
department of PROTEC GmbH & Co. KG are requested to contact the local branch of
PROTEC GmbH & Co. KG before assembly or service work is started.
For assembly and service works, it is necessary to use the description of the product
and to observe the points it contains.
NOTE
The usage of the product in combination with attachments, accessories or other
non-approved components not authorized by PROTEC is not permitted.
NOTE
According to regulation (EU) 2017/745 of medical devices, all serious incidents
related to the device must be reported to the manufacturer and the responsible
authority of the member state where the user and/or the patient is established.
