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Aesculap
AVM microclip applying forceps
Legend
1 Jaw piece with pulling rod
2 Sheath outer tube
3 Sheath
4 Rotary element
5 Lock pushbutton
6 Locking button
7 Branches left/right
8 Lock
9 Handle part
10 AVM microclip applying forceps
Symbols on product and packages
Caution, see documentation supplied with the product
1.
Intended use
The AVM microclip applying forceps is used for opening and closing the Aesculap AVM microclips.
AVM microclips are used for the temporary occlusion of small vessels in case of arteriovenous malformations (AVM)
in the brain.
2.
Indications
Indications, see Intended use.
Note
The manufacturer is not responsible for any use of the product against the specified indications and/or the described
applications.
3.
Contraindications
None known.
4.
Risks and side effects
As part of the legal obligation to provide information, the possible risks and side effects in connection with the use
of surgical instruments known to the manufacturer are highlighted below. These are predominantly process-specific,
not product-specific, and include unwanted damage to surrounding tissue, such as bleeding, infection, incompati-
bility of materials, or parts of instruments left unnoticed in the patient.
5.
Available sizes
The AVM microclip applying forceps are available in various working lengths, see brochure AVM microclips.
6.
Safe handling and preparation
►
Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge, or experience.
►
Read, follow, and keep the instructions for use.
►
Use the product only in accordance with its intended use, see Intended use.
►
Clean the new product mechanically after removing its transport packaging and prior to its initial sterilization.
►
Store any new or unused products in a dry, clean, and safe place.
►
Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.
►
Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
►
Replace any damaged components immediately with original spare parts.
7.
Safe operation
Risk of injury and/or malfunction!
►
Always carry out a function check prior to using the product.
WARNING
7.1
Engaging the lock and handing over the AVM microclip (Fig. 1)
►
Push the lock pushbutton 5 while simultaneously compressing the branches left/right 7.
Lock 8 is engaged now. With lock 8 engaged, jaw piece 1 is set in such a way that the AVM microclip is slightly
clamped between jaws 1.
7.2
Releasing the lock and applying the AVM microclip (Fig. 2)
►
Swivel rotary element 4 until the AVM microclip is in the required position.
►
Compress branches left/right 7.
Jaw piece 1 of AVM microclip applying forceps 10 closes and the clamped AVM microclip opens.
Lock 8 with lock pushbutton 5 automatically snaps back into the unlocked position, so that the AVM microclip
can be applied.
►
Apply the AVM microclip on the blood vessel.
7.3
Detaching the AVM microclip applying forceps from the AVM microclip
(Fig. 3)
►
Release the pressure on branches left/right 7.
Jaw piece 1 opens and the AVM microclip closes.
►
Detach AVM microclip applying forceps 10 from the AVM microclip.
8.
Disassembling
Reduced functionality of the AVM microclip applying forceps caused by bending
of, or damage to a component!
►
Proceed cautiously when disassembling the AVM microclip applying forceps.
►
Observe the sequential order of disassembly.
CAUTION
►
Turn locking button 6 until it is in the position shown in Fig. 4.
►
Extract jaw piece with pulling rod 1 from sheath outer tube 2.
►
Extract sheath outer tube 2 from handle part 9, see Fig. 5.
Note
Jaw piece with pulling rod 1 and sheath outer tube 2 cannot be removed from handle part 9 at the same time!
9.
Assembling
Reduced functionality of the AVM microclip applying forceps caused by bending
of, or damage to a component!
►
Apply proper care when assembling the AVM microclip applier.
►
Observe the sequence of assembly.
CAUTION
►
Turn locking button 6 back to its initial position, see Fig. 6.
Excessive load on the AVM clips, caused by using a wrong combination of jaw
piece with pulling rod, sheath outer tube and handle part!
►
Make certain the jaw piece with pulling rod, the sheath outer tube and the
handle part carry the same code number.
CAUTION
►
Fully insert the sheath outer tube into the handle part.
►
Insert jaw piece with pulling rod 1 into the sheath outer tube 2 as far as it will go, see Fig. 7.
►
Ensure that the correct position of the jaw piece with pulling rod 1 is maintained, see Fig. 8.
►
Check AVM microclip applying forceps 10 for proper functioning, see Safe operation.
10.
Validated reprocessing procedure
10.1 General safety notes
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for reprocessing.
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
It should be noted that successful reprocessing of this medical device can only be guaranteed following prior valida-
tion of the reprocessing method. The operator/reprocessing technician is responsible for this.
The specified chemistry was used for validation.
10.2 General information
Dried and hardened or clotted surgical residues can complicate cleaning or render it ineffective and cause corrosion.
Therefore, do not exceed a period of 1 h between use and processing, make sure pre-cleaning temperatures are
<45°C to prevent clotting, and do not use disinfectants that can cause clotting (active ingredient: aldehyde, alcohol).
Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking
becoming unreadable either visually or by machine.
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 damage to metallic products. These must be removed by rinsing thoroughly with demineralized water and then
drying.
Perform 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:
■
Material damage such as corrosion, cracks, fracturing, premature aging, or swelling.
►
Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause
corrosion
►
For detailed information on hygienically safe and material-friendly/careful processing, please refer to
www.a-k-i.org Header "AKI Brochures", "Red Brochure".
10.3 Reusable products
There are no known effects of processing resulting in damage to the product.
The product can be re-used up to 75 times with proper care and if it is undamaged and clean. Any additional reuse
falls under the responsibility of the user.
Careful visual and functional testing prior to the next use is the best way to identify a malfunctioning product.
10.4 Disassembling the product before carrying out the reprocessing procedure
►
Disassemble the product immediately after use, as described in the respective instructions for use.
10.5 Preparations at the place of use
►
If applicable, rinse surfaces that are not accessible to visible inspection (preferably with demineralized water),
using a disposable syringe, for example.
►
Remove any visible surgical residues as much as possible with a damp, lint-free cloth.
►
Place the wet product in a sealed waste container and take it to be cleaned and disinfected within 1 h.
10.6 Cleaning/disinfection
10.6.1 Product-specific safety notes on the reprocessing procedure
Danger to the patient!
►
Reprocess the product only with manual pre-cleaning followed by mechanical
cleaning.
DANGER
Risk to patient due to cross contamination!
►
Do not clean contaminated products together with uncontaminated products
in a tray.
DANGER
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►
Use cleaning and disinfecting agents according to the manufacturer's instruc-
tions which are approved for (e.g. aluminum, plastics, high-grade steel).
CAUTION
►
Observe specifications regarding concentration, temperature and exposure
time.
►
Do not exceed the maximum permitted cleaning temperature of 55 °C.
►
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.
►
Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disinfection.
– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/dis-
infection.
– as an integrated mechanical support measure for mechanical cleaning/disinfection.
– for additional cleaning of products with residues left after mechanical cleaning/disinfection.
►
Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the
positioning aids.
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