B.Braun Aesculap Mode D'emploi/Description Technique page 2

®
Aesculap
AdTec® needle holder
Legend
1 Jaw part
2 Lubrication points
3 Luer lock connector for cleaning channel
4 Screw handle
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the product
Date of manufacture
Intended use
The AdTec® needle holders are used for grasping and suturing in laparoscopic operations.
The applier forceps PL406R is used for fixating the counter-pressure plate of a circular stapler.
Available sizes
The AdTec® needle holders available to order are described in brochure C004 and at www.endoscopy-catalog.com
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.
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To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).
Safe operation
Risk of injury and/or malfunction!
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Always carry out a function check prior to using the product.
WARNING
Risk of injury when using the product beyond the field of view!
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Apply the product only under visual control.
WARNING
Closing the jaw piece
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To close jaw piece 1 and grasp objects without engaging the lock on handle 4, slightly compress the handle.
Engaging the lock
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To lock handle 4 and jaw piece 1, fully compress the handle until the lock engages automatically with a click.
The instrument is locked now.
Releasing the lock
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Fully compress handle 4 until the lock is released automatically with a click.
Note
After releasing the lock, the handle must be opened half-way at least before the lock can be engaged again.
Validated reprocessing procedure
General safety notes
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:
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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.
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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.
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Remove the sealing cap from the Luer lock connector.
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 (e.g. aluminum, plastics, 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 allowable temperature of 96 °C.
Validated cleaning and disinfection procedure
For mechanical cleaning:
Note
Use appropriate (neutral, enzymatic and mild-alkaline) detergents on this product with its aluminum components.
Validated procedure Specific requirements
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Manual cleaning with ultrasound
Suitable cleaning brush
and immersion disinfection
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20 ml disposable syringe
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Keep working ends open for
cleaning.
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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
■
Manual pre-cleaning with brush
20 ml disposable syringe
and subsequent mechanical alka-
■
Place the product in a tray that
line cleaning and thermal disinfec-
is suitable for cleaning (avoid-
tion
ing rinsing blind spots).
■
Connect components with
lumens and channels directly to
the rinsing port of the injector
carriage.
■
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.
Reference
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■
Chapter Manual cleaning with
ultrasound and immersion dis-
infection
Chapter Mechanical cleaning/dis-
infection with manual pre-clean-
ing and sub-chapter:
■
Chapter Manual pre-cleaning
with a brush
■
Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing