Durr Dental Hygoclave 90, Инструкция по установке и эксплуатации

Страница: 42 / 64

40
6046100064L02 1702V002SE
Operation
14 Documenting the
sterilisation
14.1 Batch documentation
The batch documentation is required as proof of
successful completion of the sterilisation pro-
cess and as a mandatory quality assurance
measure�
The data, such as the program type, batch and
process parameters for all executed programs,
is saved in the internal protocol logger of the
unit�
For the batch documentation, the internal proto-
col logger can be read out and the data trans-
ferred to various output media� This can be
done immediately after every cycle that has
been run or at a later time, e�g� at the end of the
surgery day�
Internal protocol logger
The memory capacity of the internal protocol
logger is sufficient for approx� 10,000 cycles�
If the internal protocol logger is nearly full and at
least one record has not yet been output to an
activated output medium, the message "Caution
–
Internal protocol logger almost full " is dis-
played�
Specify the defined output media under
Set-
tings > System Settings > Parameters > Log-
ging
and output the affected records�
If the records are not output, the message
"Caution –
Internal protocol logger full " is dis-
played�
This is the last opportunity to archive records
that have not yet been output� Then the data in
the protocol logger of the unit is automatically
deleted apart from the last 40 records�
Output media
It is possible to output the records for the pro-
grams that have run via the following output
media and to archive them accordingly�
– SD memory card
– Computer (via the network)
– Label printer
– Record printer
The required output media can be selected un-
der
Settings > System Settings > Parameters �
SD memory card
In the delivery state of the unit, the integrated
SD memory card is enabled as the output medi-
um for the sterilisation record�
13.9 Storing parts for sterilisation
i
Only use standards-compliant packaging for
the products to be sterilised�
i
Comply with the stated storage conditions:
– Store the parts protected against contam-
ination
– Dust-protected, e�g� in a locked cabinet
– Protected against moisture
– Protected against excessive temperature
fluctuations
– Protected against damage
The loss of integrity of the packaging of a
sterile medical device is usually linked to a
particular incident, rather than being time-re-
lated� Potential external contamination of the
sterile barrier system should be taken into
account under the aspect of aseptic prepa-
ration when defining the acceptable storage
duration and storage conditions�
Taking into account the packaging and stor-
age conditions, the maximum length of time
for which sterile product packaging (e�g�
transparent sterile product packaging) can
be stored is 6 months, but this must not ex-
ceed the expiry date� The maximum storage
time for packaging systems (combination of
sterile barrier system and protective packag-
ing) is 5 years, unless another expiry date
has been specified by the manufacturer�
Comply with country-specific laws and regu-
lations�
EN