V1.0_2021-05-17
PROGNOST XP, XPE, XPE-Akku
Instructions for use
5038-0-0002
7 of 51
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 and routinely inspected in accordance with the manufacturer's
recommendations contained in the equipment accompanying documents.
Maintenance and service is only to be performed by customers authorized by
PROTEC GmbH & Co. KG.
Live electrical terminals are deadly.
Do not remove flexible high-tension cables from X-ray tube cover or high-
tension generator and/or access covers from X-ray generator.
For all components of the equipment protective earthing means must be
provided in compliance with the national regulations.
Failure to comply with the foregoing may result in serious or fatal bodily
injuries to the operator or those in the area.
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 "Technical Description” of
the product and to observe the points it contains.
NOTE
The use of the product with add-on or accessory parts not authorized by PROTEC or
other unapproved components 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.