Validated Reprocessing Procedure; General Safety Notes; General Information; Reusable Products - B. Braun Aesculap Acculan 4 GA320 Gebrauchsanweisung/Technische Beschreibung

7.

Validated reprocessing procedure

7.1

General safety notes

Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for reprocess-
ing.
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.
Note
It should be noted that successful reprocessing of this medical device can
only be guaranteed following prior validation of the reprocessing method.
The operator/reprocessing technician is responsible for this.
The recommended chemistry was used for validation.
7.2

General information

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:
■
Visual material changes
■
Material damage (such as corrosion, cracks, breaks, premature aging or
swelling).
7.3

Reusable products

The service life of the product is limited by damage, normal wear, type and
duration of the application, handling, storage and transportation of the
product.
Careful visual and functional testing prior to next use is the best way to
identify a malfunctioning product.
7.6

Wipe disinfection for electrical devices without sterilization

Phase Step
I Wipe disinfection
RT: Room temperature
Phase I
►
Remove any visible residues with a disposable disinfectant wipe.
►
Wipe all surfaces of the optically clean product with a fresh, disposable
disinfectant wipe.
►
Observe the specified application time (1 min minimum).
►
Clean the contacts in the charging bay with isopropanol or ethyl alco-
hol and a cotton swab. Do not use corrosive chemicals.
7.7

Inspection, maintenance and checks

►
Inspect the product after each cleaning and disinfecting cycle to be
sure it is clean, functional and undamaged.
►
Set aside the product if it is damaged.
6
T t Conc.
[°C/°F] [min] [%]
≥1
RT -
7.4

Preparation before cleaning

►
Remove the batteries from the charging bays.
►
Unplug the power cord from the mains power socket.
►
Unplug power cord from the device connector 7.
7.5

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure
DANGER
Risk of electric shock and fire hazard!
►
Unplug the power cord before cleaning.
►
Do not use flammable or explosive cleaning or disinfecting solu-
tions.
►
Ensure that no fluids will penetrate the product.
CAUTION
Damage to, or destruction of the product caused by mechanical clean-
ing/disinfection!
►
Only clean and disinfect the product manually.
►
Do not sterilize the product under any circumstances.
CAUTION
Risk of damage to the product due to inappropriate cleaning/disin-
fecting agents!
►
Only use cleaning/disinfecting agents approved for surface clean-
ing. Follow the manufacturer's instructions for the respective
cleaning/disinfecting agent.
►
Do not introduce any fluid into the charging bays.
Water qual- Chemical
ity
- Meliseptol Wipes sensitive