Validated Reprocessing Procedure; Safe Operation - Braun Aesculap AdTec mini Instrucciones De Manejo/Descripción Técnica

®
Aesculap
AdTec mini instrument system
Legend
1 Handle (complete)
2 Movable part of the handle
3 HF pin
4 Star wheel
5 Actuating lever
6 Switch (lubrication point)
7 Jaw insert (lubrication point)
8 Pressure bar
9 Outer tube
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the product
Intended use
All professional disciplines that use endoscopy:
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Cutting, preparation, and grasping of tissues
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Biopsies
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Suturing
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
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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).
Risk of injury from ignition or explosion of flammable gases!
Sparks may occur when using the HF device as directed.
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Observe the safety guidelines in the instructions for use of the HF device.
WARNING
Thermal injuries to patients/users due to insufficient insulation of leads in active
accessories!
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Adjust the HF device to an appropriate setting to ensure that the peak output
voltage does match or not exceed the accessory voltage rating specified for
WARNING
the product.
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Use the instrument only with an insulated outer tube.
The manufacturer has tested the product and verified that its insulation can withstand 300 reprocessing cycles. In
clinical practice, the service life will depend on the individual intraoperative usage and the hospital's specific repro-
cessing conditions.
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Adjust the HF power output to the intended surgical intervention. Take into account clinical experience or ref-
erence values.
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Select the lowest possible HF power output.
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Keep the product's contact surfaces clean during surgery. Remove encrusted tissue residues or body fluids with
a moistened swab.
The plug end of the product is fitted with the following connector: pin, 4 mm, sprung.
Refer to our brochures to find a compatible cable.
The accessory voltage rating of the product is 2 kVp.
The accessory voltage rating must exceed or match the peak output voltage with which the product is operated in
combination with a suitable HF device at an appropriate operating mode/setting (see IEC/DIN EN 60601-2-2).
To avoid HF burns:
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Always keep the working end of the product in the user's field of vision whenever the HF power is activated.
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Prior to activating the HF device, check that the working end of the product is not touching any electrically con-
ductive accessories.
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Prior to each use, visually inspect the product for: damage or surface changes to the insulation.
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Never place the product on or next to the patient.
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When using accessories for endoscopy or laparoscopy, deactivate the automatic switch-on mode of the HF
device.
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Follow the instructions for use of the HF device.

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
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To open and close the distal end of the jaws:
– Open and close the moveable part of the handle 2.
Handle with lock
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Press actuating lever 5 to release the ratchet mechanism.
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To activate the ratchet mechanism, release actuating lever 5.
Switch 6 can be used for permanently deactivating the ratchet mechanism.
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To deactivate the ratchet mechanism on handle 1:
– Position switch 6 as shown in I.
The switch 6 clicks into the front position.
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To activate the ratchet mechanism on handle 1:
– Position switch 6 as shown in II.
The switch 6 clicks into the rear position.
Disassembling
Note
For disassembling the product, also see additional series of illustrations A.
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Deactivate the ratchet mechanism on handle 1 with lock:
– Position switch 6 as shown in I.
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Detach the shaft from handle 1:
– Push star wheel 4 back, hold it there, and remove the shaft.
– Extract jaw insert 7, together with outer tube 9, from handle 1.
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Disassemble the shaft:
– Remove outer tube 9 from jaw insert 7.
– Rotate pressure bar 8 counterclockwise by 90° and extract it from jaw insert 7.
Assembling
Note
For assembling the product, also see additional series of illustrations B.
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Deactivate the ratchet mechanism on handle 1 with lock:
– Position switch 6 as shown in I.
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Assemble the shaft:
– Slide pressure bar 8 into jaw insert 7 and rotate it clockwise by 90°.
– Slide outer tube 9 onto jaw insert 7 as far as it will go.
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Hold the assembled shaft at jaw insert 7 with one hand.
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With the other hand, hold handle 1 at star wheel 4. The moveable part of the handle 2 must remain freely move-
able.
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Push the shaft into handle 1, making certain that the notch on pressure bar 8 is aligned with the mark on star
wheel 4.
The moveable part of the handle 2 moves upward.
The shaft engages automatically when it reaches the stop.
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Test the instrument for proper functioning by opening and closing the jaws.

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:
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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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Disassemble the product immediately after use, as described in the respective instructions for use.
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Open up instruments with hinges.