Reprocessing Procedure; General Safety Notes; Reusable Products; Preparation Before Cleaning - B. Braun Aesculap ELAN 4 GA800 Gebrauchsanweisung

en
7.

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.
7.2

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.
7.3

Preparation before cleaning

►
Separate the products from each other immediately after use.
►
Shut down control unit 1 immediately after use, see Chapter 6.1.5.
►
Remove any visible surgical residues as much as possible with a damp,
lint-free cloth.
7.5

Wipe disinfection for electrical equipment

Phase Step
I Cleaning
II Wipe disinfection
RT: Room temperature
* Recommended: Meliseptol® wipes sensitive (B. Braun)
Phase I
►
Remove any visible residues with a disposable disinfectant wipe.
Phase II
►
Wipe all surfaces of the optically clean product with a fresh, disposable
disinfectant wipe.
►
Observe contact time requirements (at least 1 min).
7.6

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.
16
T t Conc. Water quality
[°C/°F] [min] [%]
RT 1 - -
≥1
RT - -
7.4

Cleaning/disinfection

7.4.1 Product-specific safety instructions for the reprocessing pro-
cedure
DANGER
Risk of electric shock and fire hazard!
►
Unplug the device 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!
►
Clean the product with wipe disinfection only.
►
Do not sterilize the product under any circumstances.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting
agents!
►
Only use cleaning/disinfecting agents approved for surface clean-
ing. Follow the manufacturer's instructions for the respective
cleaning/disinfecting agent.
►
Do not clean the product in a ultrasonic bath and do not immerse the
product in any fluids.
Chemicals
17 % Propan-1-ol,
0.23 % Didecyldimethylammonium chloride*
17 % Propan-1-ol,
0.23 % Didecyldimethylammonium chloride*
8.

Maintenance

To ensure reliable operation, the product must be maintained at least once
a year.
Contact your national B. Braun/Aesculap representative if you need these
services, see Chapter 10.