Working With The Device; Validated Reprocessing Procedure - B. Braun Aesculap Acculan GA346 Gebrauchsanweisung/Technische Beschreibung

Aesculap
Acculan 4 Li-Ion battery short GA346
6.

Working with the device

6.1 System set-up
►
See instructions for use for the respective Acculan machine and the
Acculan 4 charger GA320.
6.2 Functional test
See the instructions for use for the respective Acculan machine.
6.3 Safe operation
Risk of injury and material damage due to inappro-
priate use of batteries!
►
WARNING Charge battery only in the Acculan 4 charger
GA320.
►
Insert battery correctly (Acculan machine and
charger).
Risk of injury and material damage due to damaged
batteries!
►
Check batteries for any damage before charg-
WARNING
ing.
►
Do not use or recharge damaged batteries.
►
For proper loading and removal of the battery from the Acculan
machine, see the instructions for use for the respective Acculan
machine.
7.

Validated reprocessing procedure

7.1 General safety information
Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for sterile pro-
cessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possi-
ble variants of CJD, observe the relevant national regulations concerning
the reprocessing of products.
4
Acculan
®
Note
Successful processing of this medical device can only be ensured if the pro-
cessing method is first validated. The operator/sterile processing techni-
cian is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For the latest information on reprocessing and material compatibility see
also the Aesculap extranet at https://extranet.bbraun.com
7.2 General notes
Only process chemicals that have been tested and approved (e.g. VAH or
FDA approval or CE mark) and which are compatible with the product's
materials according to the chemical manufacturers' recommendations
may be used for processing the product. All the chemical manufacturer's
application specifications must be strictly observed. Failure to do so can
result in the following problems:
■
Optical changes of materials, e.g. fading or discoloration of titanium or
aluminum. For aluminum, the application/process solution only needs
to be of pH >8 to cause visible surface changes.
■
Material damage such as corrosion, cracks, fracturing, premature aging
or swelling.
►
Do not use metal cleaning brushes or other abrasives that would dam-
age the product surface and could cause corrosion.
7.3 Preparing for cleaning
►
Remove the battery from the Acculan machine.
7.4 Cleaning/Disinfection
Device-specific safety information on the reprocessing method
Risk of electric shock and fire hazard!
►
Do not use flammable or explosive cleaning or
disinfecting solutions.
DANGER
►
Ensure that no fluids will penetrate the product.
Damage to, or destruction of the product caused by
mechanical cleaning/disinfection!
►
CAUTION Only clean and disinfect the product manually.
►
Do not sterilize the product under any circum-
stances.