Aesculap clip applier forceps

en ®

Aesculap Aesculap clip applier forceps Legend 1 Jaw part 2 Branches left/right 3 Clip applier forceps

Caution, general warning symbol Caution, see documentation supplied with the product

Intended use

Aesculap clip applier forceps are used for holding and applying Aesculap YASARGIL Phynox and titanium aneurysm clips and Aesculap KOPITNIK AVM microclips in neurosurgical procedures. Note Aesculap In the following, YASARGIL aneurysm clips and Aesculap KOPITNIK AVM microclips are referred to as “clips”.

2.

Detaching the clip applier forceps from the clip ► Release the pressure on branches left/right 2. Jaw piece 1 of clip applier forceps 3 opens and the clip closes. ► Detach clip applier forceps 3 from the clip.

7.2

Symbols on product and packages

1.

Releasing the lock ► Compress branches left/right 2. Jaw piece 1 of clip applier forceps 3 closes and the clip opens. The lock automatically returns to the unlocked position.

Indications

Indications, see Intended use.

Vario clip applier forceps

The Aesculap Vario clip applier forceps offer an additional rotary function for positioning of the clip in the clip applier forceps. The maximum range of rotation at the working end of the Aesculap Vario clip applier forceps is 20° in each direction, starting from the middle position, see Fig. 2. The adjusting plates of the Aesculap Vario clip applier forceps can be used for parallel alignment of the applier jaws, see Fig. 3. The adjusting plates allow swiveling the clamping jaws by 320°, see Fig. 4.

8.

Validated reprocessing procedure

8.1

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 The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.

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.

3.

8.2

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

Detailed information on available sizes can be found in the main Neurosurgery Catalog and in the Yasargil Aneurysm Clips brochures. All clip applier forceps are marked according to size (Mini or Standard, Long or AVM micro) and clip material (Phynox or titanium) so that their correct application with clips of the appropriate size and material is ensured.

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

CAUTION Damage to, imprecise function and incorrect closing force of the clips due to use of incorrect applier forceps! ► Use Aesculap clip applier forceps only. ► Use clips only with the appropriate Aesculap clip applier forceps (see labels). ► Use clips and clip applier forceps only in the following combinations:

– – – – – –

7.1

Titanium Standard clips with the clip applier forceps for Titanium Standard clips Phynox Standard clips with the clip applier forceps for Phynox Standard clips Titanium Mini clips with the clip applier forceps for Titanium Mini clips Phynox Mini clips with the clip applier forceps for Phynox Mini clips Phynox Long clips with the clip applier forceps for Phynox Long clips AVM clips with the applier forceps for AVM clips

Locks

Note Some clip applier forceps variants are fitted with a lock to engage during clip transfer. The clip applier forceps may be fitted with one of the following locks: ■ Permanent lock ■ Button-controlled lock

7.1.1

Operating the permanent lock

Note With the clip applier forceps with permanent lock, the lock is always active and cannot be switched off. ► Insert the clip into jaw piece 1. ► Compress branches left/right 2 until the lock engages.

The clip is in transfer position. ► Move clip applier forceps 3 with the clip into the operating field. ► To release the lock, slightly compress branches left/right 2. ► Apply the clip.

7.1.2

Operating the button-controlled lock

Note The clip applier forceps with button-controlled lock can be used with or without the locking function. The locking function of the button-controlled lock needs to be activated deliberately by pressing the lock button. Transferring the clip and engaging the lock ► Insert the clip into jaw piece 1. ► Push the lock button and simultaneously compress branches left/right 2. The lock is engaged and the clip is slightly clamped in jaw piece 1.

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 1h between use and processing, make sure pre-cleaning temperatures are <45°C to prevent fixing, and do not use disinfectants that can cause fixing (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: ■ Optical changes in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum, the application/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. ► 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".

8.3

Reusable products

There are no known effects of processing resulting in damage to the product. The black-coated appliers can be re-used up to 500 times with proper care and if they are undamaged and clean. The titanium appliers, identifiable by the article numbers FT…T, can be reused up to 100 times with proper care and if they are undamaged and clean. The Phynox appliers, identifiable by the article numbers FE…K, can be reused up to 200 times with proper care and if they are undamaged and clean. The products FE502T and FE512T can be reused up to 100 times with proper care and if they are undamaged and clean. Any additional reuse falls under the responsibility of the user. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

8.4

Disassembling the product before carrying out the reprocessing procedure

► Open up instruments with hinges.

8.5

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 1h.

8.6

Cleaning/disinfection

8.6.1

Product-specific safety notes on the reprocessing procedure

DANGER Danger to the patient! ► Only reprocess the product using machine cleaning. DANGER Risk to patient due to cross contamination! ► Do not clean contaminated products together with uncontaminated products in a tray. 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), – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 55 °C. ► Do not use oxidizing chemicals (e.g. H2O2), which could cause bleaching/layer loss of the product. ► 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. ► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids.

8.7

Mechanical alkaline cleaning and thermal disinfection

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). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals. 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® SeptoClean 1 % Working solution2)

III

Neutralization

>10/50

2

DI–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

DI–W

-

VI

Thermal disinfection

90/194

5

DI–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) ► Place instruments in the tray with their hinges open. ► 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.

8.8

Inspection, maintenance and checks

CAUTION 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 Tech-

nical Service.

8.9

Packaging

► Appropriately protect products with fine working tips. ► Store products with ratchet locks fully opened or locked no further than in the first notch. ► 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.

8.10 Steam sterilization ► 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 load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

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

9.

Technical Service

WARNING Risk of injury and/or malfunction! ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency.

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. TA013089

2020-06

V6

Change No. 60793