Durr Dental 6024100001, Installation And Operating Instructions Manual

Page: 23 / 36

14 Validation of the sealing
process
14.1 Validation steps
The validation of the sealing process consists of
the following steps:
– Installation qualification; this must be per-
formed during commissioning of the device,
see 8.2 Handover of the device.
– Operational qualification; to be performed
daily.
– Performance testing; to be performed annu-
ally.
14.2 Daily function assessment
If the menu item Operational qualification (OQ) is
activated in the menu of the unit, then a request
to perform an operational qualification of the
sealing process will appear every day after the
unit is switched on for the first time.
This is only a reminder function and does
not remove the responsibility for carrying
out the operational qualification for the
validation.
❯
Switch on the unit with button .
The display window shows the setpoint tem-
perature and the actual temperature.
The blue LED flashes during the heat-up
phase.
As soon as the target temperature has been
reached, the unit is ready for operation.
The blue LED goes out.
❯
Insert a seam sealing test, e.g. Hygopac
Sealcheck, as directed in the instructions into
the transport until the unit starts up and the
seam sealing test is drawn in.
The batch number is briefly displayed in the
display window.
❯
After the sealing process, check the quality of
the sealing seam:
❯
Uniform and fully executed
❯
Free of folds and flaws
❯
Free of delamination
❯
Colour corresponds to the industrial seam
❯
Peelability corresponds to the industrial seam
❯
If the outcome of the operational qualification is
satisfactory, tap
Yes in the Seam sealing test
OK? screen to switch the unit to 'ready for
operation'.
❯
If the outcome of the operational qualifica-
tion is not satisfactory , tap No in the Seam
sealing test OK? screen.
The following appears on the screen: Please
adjust temperature
❯
Tap
OK
.
❯
Adjust the temperature (directly via the menu)
as required.
❯
Tap Save .
❯
Repeat the operational qualification.
If the operational qualification is unsuc-
cessful despite adjusting the temperature
several times, please contact a Service
Technician.
14.3 Annual Performance Qualifi-
cation
If, in the menu of the unit, the menu item Perfor-
mance Qualification (PQ = Performance Qualifi-
cation) is activated, a request will appear once a
year to carry out a performance qualification of
the sealing process.
This is only a reminder function and does
not remove the responsibility for carrying
out the performance qualification for the
validation.
❯
Switch on the unit with button .
The display window shows the setpoint tem-
perature and the actual temperature.
As soon as the target temperature has been
reached, the unit is ready for operation.
❯
The following is shown on the display:
Start performance qualification?
Tap
Yes .
❯
The following is shown on the display:
Apply 3 seals for each foil type (e.g. manufac-
turer, material, foil width).
❯
Tap Start .
The following is shown on the display:
Supply test foil.
❯
Perform all the required sealing processes one
after the other, i.e.
seal
3 sets of unfilled sterilisation packaging of
the same type (e.g. manufacturer, material, foil
width) for each one.
❯
Tap
Exit
.
❯
Label the sterilisation packaging with the
device name and serial number of the sealing
device and the parameters of the sealing pro-
cess and document this information.
Usage
6024100132L02 1906V003 21
EN