B.Braun 011883 Mode D'emploi page 3

Mechanical cleaning/disinfecting with manual pre-cleaning
Manual pre-cleaning with brush
Stage Step T
[°C/°F]
I Disinfecting RT
ultrasound cleaning (cold)
II Intermediate rinse RT
(cold)
D–W: Drinking water
RT: Room Temperature
Stage I
Fully immerse the product in the disinfecting solution. Make certain that all accessible surfaces are moistened.
Clean the product with a fitting cleaning brush (see Endoscopy online catalog www.endoscopy-catalog.com or
Aesculap brochure C357.01/02 (MIT System)) until no visible residues are left on the surface.
Brush through all surfaces that are not accessible to visual inspection, e.g. in products with hidden crevices,
lumens or complex geometries, for at least 5 min or until no more residues can be removed. Mobilize non-rigid
components, e.g. set screws, joints, etc. during cleaning.
After that, thoroughly rinse (at least 5 times) with the cleaning solution these difficult to access areas of the
product, using a single-use syringe (20 ml).
To avoid the risk of corrosion, do not use a metal brush or other abrasives that would damage the surfaces for
cleaning the product.
Stage II
Rinse the product completely (all accessible surfaces) under running water.
Mechanical alkaline cleaning and thermal disinfecting
Machine type: Single-chamber cleaning/disinfecting machine without ultrasound
Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).
Connect components with lumens and channels directly to the injector carriage attachment.
Store products with hinges or joints on the tray in such a way that the joints are kept open.
Stage Step T
[°C/°F]
I Prerinse <25/77
II Cleaning 55/131
III Neutralization 20/68
IV Intermediate rinse 70/158
V
Thermal disinfecting 94/201
VI Drying 90/194
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
Control, care and inspection
Allow the product to cool down to room temperature.
Assemble the separable product, see Assembling.
Inspect the product after each cleaning and disinfecting cycle to be sure it is clean, functioning properly and
not damaged (e.g. insulation), and do not have any loose, bent, broken, cracked, worn, or fractured components.
Check for compatibility with associated products.
Set aside the product if it is damaged.
Packaging
Sort the product into its appropriate storage device or put it on a suitable tray. Observe the weight limit for
each tray/container.
Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
Pack the product in such a way that the packaging will prevent recontamination of the product in the period
between reprocessing and reuse.
Sterilization method and parameters
Note
The product can be sterilized either in disassembled or in assembled condition.
Make certain that all external and internal surfaces will be exposed to the sterilizing agent (e.g. by opening all
valves and stop-cocks).
Sterilize with steam, complying with the following rule:
Sterilization must be carried out through a validated steam sterilization process (e.g. in a sterilizer according to
EN 285/ANSI/AAMI/ISO 11134-1993, ANSI/AAMI ST46-1993, and validated according to EN ISO 17665 or
EN 554/ISO 13683). For the fractionated vacuum process, sterilization has to be carried out with the 134 °C/
2 bar program for a minimum holding time of 5 minutes.
When sterilizing several products at the same time in one steam sterilizer: Make certain that the maximum
allowable load capacity of the steam sterilizer, as specified by the manufacturer, is not exceeded.
Sterilization for the US market
• Sterilization of the device may be accomplished by steam.
• Aesculap does not recommend the device be sterilized by "Flash" or chemical sterilization.
• Surgical instruments may also be placed within an Aesculap rigid sterilization container (sterile container) for
processing under generally accepted hospital in-use conditions.
The recommended sterilization parameters are as follows:
Sterilization method Temp.
Pre-vacuum 270—275 °F
t Conc. Water Chemical
[min] [%] quality
15 2 D–W BBraun Stabimed; aldehyde phenol
and QAV free; pH = 9
1 - D–W -
t Water Chemical
[min] quality
3 D–W -
10 FD–W - concentrate, alkaline: pH = 10.9
<5 % anionic tensides
- 1 % solution: pH = 10.5
2 FD–W - concentrate, alkaline: pH = 2.6
Basis: Citric acid
- 0.1 % solution: pH = 3.0
1 FD–W -
10 FD–W -
40 - -
Minimum exposure time
Wrapped In a sterile container system
4 min 4 min
WARNING for the US market
If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device
cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of
cross-contamination!
Storage
Store reprocessed products under conditions as germ-free as possible, in a dry, dark, cool and dust-protected
room.
Technical Service
For service, maintenance or repairs, contact your national B. Braun/Aesculap agency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and for-
feiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 7461 95-2700
Fax: +49 7461 16-2887
E-mail: ats@aesculap.de
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood, MO 63042
Aesculap Repair Hotline
Phone: +1 800 214-3392
Fax: +1 314 895-4420
Other service addresses can be obtained from the address indicated above.
Accessories/Spare parts
See Endoscopy online catalog
www.endoscopy-catalog.com
or Aesculap brochure C357.01/02 (MIT System)
Distributor in the US/Contact in Canada for product information and
complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA 18034
USA
TA-Nr.: 011883 01/07 Änd.-Nr.: 29739