Safe Operation; Validated Reprocessing Procedure - Braun Aesculap Neurosurgery Instructions For Use/Technical Description

®
Aesculap
YASARGIL aneurysm clip removal forceps
Legend
1 Jaw part
2 Branches left/right
3 Clip removal forceps
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the product
Intended use
Aesculap YASARGIL aneurysm clip removal forceps are used to remove Aesculap YASARGIL titanium aneurysm clips
in neurosurgical procedures.
Note
In the following, the Aesculap YASARGIL aneurysm clips will be referred to simply as "clips".
Available sizes
Detailed information on available sizes can be found in the main Neurosurgery Catalog and in the YASARGIL Aneu-
rysm Clips brochures.
All removal forceps are marked according to size (Mini or Standard) and clip material (titanium) so that their correct
application with clips of the appropriate size and material is ensured.
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
►
Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge, or experience.
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Read, follow, and keep the instructions for use.
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Use the product only in accordance with its intended use, see Intended use.
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Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial
sterilization.
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Store any new or unused products in a dry, clean, and safe place.
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Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.
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Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
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Replace any damaged components immediately with original spare parts.

Safe operation

Damage, imprecise function and incorrect closing force of the clips due to incor-
rect choice of removal forceps!
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Only use Aesculap clip removal forceps.
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Use clips only with the appropriate Aesculap clip removal forceps (see labels).
CAUTION
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Use the clip removal forceps only in the following combinations:
– Titanium Standard clips with the clip removal forceps for titanium Standard clips
– Titanium Mini clips with the clip removal forceps for titanium Mini clips
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Adapt the applied clip in jaw piece 1.
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Actuate branches left/right 2.
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Take clip removal forceps 3 with the clip out of the operating field.

Validated reprocessing procedure

General safety instructions
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
Note
Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/sterile processing technician 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
www.extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
General information
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the
time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temper-
atures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used.
Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the
laser marking becoming unreadable visually or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water
used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in
the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water
and then drying.
Additional drying, if necessary.
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. Fail-
ure 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 applica-
tion/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.
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Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
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Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-
k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Disassembling the product before carrying out the reprocessing procedure
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Open up products with hinges.
Preparations at the place of use
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If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.
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Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
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Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
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Use cleaning and disinfecting agents according to the manufacturer's instruc-
tions which
CAUTION
– are approved for use, for example, on aluminum, plastic materials, and
high-grade steel,
– do not attack softeners (e.g. in silicone).
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Observe specifications regarding concentration, temperature and exposure
time.
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Do not exceed the maximum permitted cleaning temperature of 55 °C.
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Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the
product thoroughly with running water.
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Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the
positioning aids.
Validated cleaning and disinfection procedure
Validated procedure Specific requirements
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Manual cleaning with immersion
Cleaning brush
disinfection
■
20 ml disposable syringe
■
When cleaning products with
movable hinges, ensure that
these are in an open position
and, if applicable, move the
joint while cleaning.
■
Drying phase: Use a lint-free
cloth or medical compressed air
■
Mechanical alkaline cleaning and
Cleaning brush
thermal disinfection
■
Place the product in a tray that
is suitable for cleaning (avoid-
ing rinsing blind spots).
■
Place products in the tray with
their hinges open.
Manual cleaning/disinfection
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Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.
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After manual cleaning/disinfection, check visible surfaces visually for residues.
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Repeat the cleaning /disinfection process if necessary.
Manual cleaning with immersion disinfection
Phase Step T
[°C/°F]
I Disinfecting RT (cold)
cleaning
II Intermediate RT (cold)
rinse
III Disinfection RT (cold)
IV Final rinse RT (cold)
V Drying RT
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
RT: Room temperature
*Recommended: BBraun Stabimed
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Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Phase I
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Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are
moistened.
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Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
from the surface.
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If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.
Reference
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■
Chapter Manual cleaning with
immersion disinfection
Chapter Mechanical cleaning/dis-
infecting and sub-chapter:
■
Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing
t Conc. Water Chemical
[%] quality
[min]
>15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1 - D–W -
15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1 - FD-W -
- - - -