V4.0_2021-05-26
PROGNOST XS
Instructions for use
5034-0-0002
16 of 25
Daily monitoring before and during the examination operation
The locking of the rolls must be checked by operating the fixation brakes.
Regular Monitoring
In case of heavy contamination, the rolls must be cleaned to ensure sufficient floor adhesion. The rolls
must be cleaned once a week. Clean the rolls with a damp cloth and a soap-free cleaning agent, or
commercially available medical rapid disinfection wipes and wipe dry.
5.4.2.1
Safety-related checks
In the interest of patients, operators and external third parties, it is necessary that all checks regarding
operational safety and/or functionality of the unit are carried out regularly every
12 months
by
PROTEC
customer service or a
PROTEC
authorized service provider.
All components within the PROGNOST XS that may pose a risk due to attrition must be inspected and,
if necessary, replaced every 12 months by the PROTEC service department or a PROTEC authorized
service provider.
In the case that the scheduled checks are not carried out, PROTEC GmbH & Co. KG will not be liable for
damage to the user and third parties if and insofar as damage results from insufficient or non-
performed checks.
Maintenance
The required maintenance must be carried out by PROTEC customer service or a service authorized by
PROTEC to ensure the safe and reliable functioning of the device. The maintenance intervals depend on
the frequency of use. In the event that the scheduled maintenance is not carried out, PROTEC GmbH &
Co. KG will not be liable for damage to the user and third parties if and insofar as damage results from
insufficient or non-performed maintenance.
Prior to test operation, the user must satisfy himself that all safety relating devices listed in the
instruction manual are in working order and that the product is ready for operation.
Attrition parts must be replaced with original components.
NOTE
The maintenance checklist must be printed out from the instruction manual and
recorded.
NOTE
After maintenance and service work, the recommissioning must be recorded with
the PROTEC acceptance protocol FB-04-07A4.
5.4.3.1
Maintenance checklist
This maintenance checklist serves as a working aid for maintenance on a “PROGNOST XS” and should
be performed every 6 months for more than 100 patients/day and every 12 months for less than 100
patients/day, depending on the use of the device.
This procedure does not replace the mandatory acceptance test or other procedures for checking X-ray
equipment specified by European standards or internal country standards. This procedure is intended
for the periodic inspection of the X-ray components and its maintenance in accordance with the
requirements of the manufacturer PROTEC GmbH & Co. KG.