XS clip applying forceps

en

7.3 ®

Aesculap XS clip applying forceps 1 2 3 4 5 6 7 8 9

Jaw piece 1 opens and the aneurysm clip closes. ► Detaching the XS clip applying forceps 9 from the aneurysm clip.

8.

Legend Jaw piece with pulling rod Sheath outer tube Sheath Rotary element Lock pushbutton Locking button Branches left/right Lock XS clip applying forceps

Detaching the XS clip applying forceps from the aneurysm clip (Fig. 3)

► Release the pressure on branches left/right 7.

Disassembling

WARNING

Reduced functionality of the XS clip applying forceps due to bending of, or damage to, a component! ► Apply proper care when disassembling the XS clip 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.

9.

Assembling

Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product

CAUTION

Reduced functionality of the XS clip applying forceps due to bending of, or damage to, a component! ► Apply proper care when assembling the XS clip applying forceps. ► Observe the sequential order of assembly.

► Turn locking button 6 to its initial position, see Fig. 5.

1.

Intended use

The XS clip applying forceps is used for opening and closing Aesculap Yasargil Phynox and titanium aneurysm clips. Note In the following text, Aesculap YASARGIL aneurysm clips are referred to as aneurysm clips.

2.

Indications

CAUTION

Excessive load on the aneurysm clips, caused by using a wrong combination of jaw piece/pulling rod and sheath outer tube! ► Verify that the code numbers and text on the jaw piece with pulling rod tally with those on the sheath outer tube.

► Verify that the code numbers and text on the jaw piece with pulling rod tally with those on the sheath outer

Indications, see Intended use.

tube, see Fig. 6.

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

► Insert jaw piece 1 with pulling rod until it engages in the sheath outer tube 2, ensuring that the correct assembly

3.

10.

Contraindications

None known.

4.

Validated reprocessing procedure

10.1 General safety notes

Risks and side effects

As part of the legal duty to inform, the following typical risks and side effects associated with the use of surgical instruments are referred to. These are predominantly procedure-specific, non product-specific and not limited to unwanted damage to surrounding tissue resulting in e.g. bleeding, infection, material incompatibilities or instrument parts remaining unnoticed in the patient, etc.

5.

position of the jaw piece with pulling rod 1 is maintained, see Fig. 7. ► Inspect the XS clip applying forceps for proper functioning, see Safe operation.

Available sizes

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.

XS clip applying forceps are available in various working lengths (see brochure for Yasargil aneurysm clips). All XS clip applying forceps are marked according to size (Mini or Standard) and clip material (Phynox or titanium) so that their correct application with aneurysm clips of the respective size and material can be ensured.

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.

6.

10.2 General information

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

WARNING

Damage to, imprecise functioning and incorrect closing force of the aneurysm clips caused by use of inappropriate clip applying forceps! ► Use aneurysm clips only with the appropriate Aesculap clip applying forceps; note the relevant markings.

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 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 Influences of treatment that lead to damage to the product are not known. The product can be re-used up to 75 times with proper care and if it is undamaged and clean. The user shall be responsible for any further reuse. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

The aneurysm clips must be used in the following combinations: ■ Phynox aneurysm clips must be applied with the XS clip applying forceps for Phynox aneurysm clips. ■ Titanium aneurysm clips must be applied with the XS clip applying forceps for titanium aneurysm clips. ■ Mini and Standard aneurysm clips must be applied with the XS clip applying forceps of the appropriate size (Mini or Standard, respectively).

10.4 Disassembling the product before carrying out the reprocessing procedure

7.1

► 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.

Inserting the aneurysm clip and engaging the lock (Fig. 1)

► Make certain that jaw piece 1 cannot be pulled out of sheath 3. ► Insert the aneurysm clip into jaw piece 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 adjusted so that the aneurysm clip is lightly clamped in between jaws 1.

7.2

Releasing the lock (Fig. 2)

WARNING

Injury to the patient caused by aneurysm clips snapping out of the applying forceps! ► Never turn the locking button while an aneurysm clip is held in the XS clip applying forceps.

► 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.

10.6 Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling.

10.7 Cleaning/disinfection 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

► Turn rotary element 4 until the aneurysm clip is in the desired position. ► Compress branches left/right 7.

Jaw piece 1 of XS clip applying forceps 9 closes and the aneurysm clip opens. Lock 8 and lock pushbutton 5 automatically click back to the unlocked position.

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 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.

CAUTION

► 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.

10.11 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 load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

10.12 Storage

10.8 Mechanical cleaning/disinfection with manual pre-cleaning

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

Note The cleaning and disinfection device must in principle have a tested effectiveness (e.g. compliance with EN ISO 15883).

11.

Technical Service

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

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

Manual pre-cleaning using brush WARNING 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:

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

Drinking water Room temperature

Phase I ► Clean the product using a suitable cleaning brush in the solution until there is no residue 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.

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

FD–W

Dr. Weigert neodisher® SeptoClean 1 % 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

DI–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 PG8535 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 components with lumens and channels directly to the rinsing port of the injector carriage. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

10.9 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. ► Assemble dismountable products, see Assembling.

10.10 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.

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!

TA011174

2020-06

V6

Change No. 60792