AVM microclip applying forceps

en

9.

Assembling

®

Aesculap AVM microclip applying forceps CAUTION

Legend

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.

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

► Turn locking button 6 back to its initial position, see Fig. 6.

Symbols on product and packages

► Check AVM microclip applying forceps 10 for proper functioning, see Safe operation.

Caution, see documentation supplied with the product

CAUTION

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. ► 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.

10.

Validated reprocessing procedure

10.1 General safety notes

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, incompatibility 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.

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 validation 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. Failure 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.

WARNING

7.1

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing.

Engaging the lock and handing over the AVM microclip (Fig. 1)

► Push the lock pushbutton 5 while simultaneously compressing the branches left/right 7.

10.6 Cleaning/disinfection 10.6.1 Product-specific safety notes on the reprocessing procedure

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

Danger to the patient! ► Reprocess the product only with manual pre-cleaning followed by mechanical cleaning.

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.

DANGER

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)

Risk to patient due to cross contamination! ► Do not clean contaminated products together with uncontaminated products in a tray. DANGER

► 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

CAUTION

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.

► 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!

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which are approved for (e.g. aluminum, plastics, high-grade steel). ► 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/disinfection. – 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.

10.7 Mechanical cleaning/disinfection with manual pre-cleaning

11.

Technical Service

Note As a matter of principle, the efficacy of the cleaning and disinfection device must be certified (e.g. in accordance with EN ISO 15883).

Risk of injury and/or malfunction! ► Do not modify the product.

Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.

10.7.1 Manual pre-cleaning using a brush

► For service and repairs, please contact your national B. Braun/Aesculap agency.

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Cleaning

RT (cold)

>15

1

D–W

B. Braun Stabimed® fresh

II

Rinsing

RT (cold)

1

-

D–W

-

D–W: RT:

Drinking water Room temperature

Phase I ► Clean the product in the solution using a suitable cleaning brush until no residue is visible on the surface. ► If applicable, use a suitable cleaning brush to brush any surfaces that are not visible for at least 1 min. ► Mobilize non-rigid components, such as set screws and hinges, during cleaning. ► Then flush these areas thoroughly at least five times with the cleaning disinfectant solution using a disposable syringe (20 ml). Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws and hinges, during rinsing.

10.7.2 Mechanical alkaline cleaning and thermal disinfection Type of device: Single-chamber cleaning/disinfection device without ultrasound1) Phase

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

DI–W

Dr. Weigert neodisher® SeptoClean1 % Working solution2)

III

Neutralization

>10/50

2

FD–W

B. Braun Helimatic® Neutralizer C Working solution 0.15 %

IV

Intermediate rinse I

>10/50

1

DI–W

-

V

Intermediate rinse II

>10/50

1

FD–W

-

VI

Thermal disinfection

90/194

5

FD–W

-

VII

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

D–W: Drinking water DI–W: Deionized water 1) The cleaning and disinfection devices listed below were used to verify cleanability: Miele 7836 CD 2) Prion-deactivating detergent (see Specifications Dr. Weigert neodisher® SeptoClean) ► Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots) ► Open the links and joints before placing the product on the screen basket. ► Connect the lumens and channels of individual parts directly to the injector unit's special flushing connector. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

10.8 Inspection, maintenance and checks

CAUTION

WARNING

Damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,

and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Assemble dismountable products, see Assembling.

10.9 Packaging ► Appropriately protect products with fine working tips. ► Store products with ratchet locks fully opened or locked no further than in the first notch. ► Close the locks so that the jaw tips just touch each other. ► Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in sterile Aesculap containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

10.10 Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

opening any valves and faucets). ► Validated sterilization process

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractional vacuum process at 134 °C, holding time 18 minutes for prion inactivation ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum permitted load specified by the manufacturer for the steam sterilizer is not exceeded.

10.11 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

12.

Disposal

► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!

TA011117

2020-06

V6

Change No. 60792