Slim Clip Applier

en

The clip appliers can be differentiated using the colored marking pins 4 and using article labeling. ®

Aesculap YASARGIL Aneurysm Clip System Slim Clip Applier Legend 1 2 3 4 5 6 7 8

Jaw part Branches left/right Lock with fixing screw Color-coding button Noir® coated clip applier Rotating platforms Vario clip applier forceps Adjusting plates

Size

Color-coding button

Standard

Blue

Mini

Red

► Mini and Standard aneurysm clips must only be applied with the clip applier forceps of the appropriate size (Mini

or Standard). ► Slim clip appliers may only be used with YASARGIL titanium aneurysm clips from Aesculap.

Note Repositioning of the clip is possible with the slim clip appliers, but removal of the clip with Aesculap removal forceps is recommended. Locking function Malfunction or damage to the product by changing the lock! ► Do not re-mount a lock that has already been dismounted once. ► Do not manipulate the lock by bending.

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

CAUTION Note The clip applier forceps can be used with or without locking function.

REF

Manufacturer’s article number

LOT

Manufacturer’s batch designation

QTY

Delivery quantity

Note The locked position of the forceps is not possible with a dismantled lock.

7.3

Use with locking function

► Insert the aneurysm clip into jaws 1. ► Compress branches left/right 2 until the lock 3 engages.

Manufacturer

Date of manufacture

The clip is in transfer position. ► Move clip applier forceps 5 with clip into the operating field. ► To release the lock, compress branches left/right 2.

The clip opens. The lock automatically returns to the unlocked position. ► Fully release branches left/right 2. The aneurysm clip closes. ► Detach the clip applier forceps 5 from the aneurysm clip.

7.4

Use without locking function

► Uninstall the lock 3 by loosening the fixing screw. ► Insert the aneurysm clip into jaw piece 1. ► Compress branches left/right 2.

The inserted aneurysm clip opens.

CE-approved in accordance with Directive 93/42/EEC

► Fully release branches left/right 2.

The aneurysm clip closes. ► Detach the clip applier forceps 5 from the aneurysm clip.

1.

General advisory note

In the following text, "Aesculap YASARGIL aneurysm" clips are referred to as "aneurysm clips". In the following text, the slim clip appliers are also referred to as "clip applier forceps." General risk factors associated with surgical procedures are not described in this documentation.

2.

Intended use

7.5

Vario clip applier forceps

The Aesculap Vario clip applier forceps 7 offer an additional rotary function for positioning of the clip in the clip applier forceps. The adjusting plates 8 of the Aesculap Vario clip applier forceps can be used for the adjustment in parallel of the rotary plates 6 in the jaw part. The adjusting plates (FT402800) can be used to turn the rotary plates 6.

The slim clip applier is used to open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips within the framework of neurosurgical interventions.

8.

Safety notes

8.1

Users

3.

Indications

4.

Absolute contraindications

5.

Relative contraindications

CAUTION Federal law restricts this device to sale by, or on order of a physician! Appropriate clinical training as well as a theoretical and practical command of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. Aesculap is not responsible for complications caused by: ■ Incorrect indication diagnosis or clip selection ■ Incorrect surgical technique ■ Incorrect combination of implant components, particularly combination with components of other manufacturers ■ Exceeding the limitations of the treatment method or non-observance of essential medical precautions The user has a duty to consult with the manufacturer for information if the preoperative situation regarding use of the implants is ambiguous.

■ Clipping of cerebral aneurysms ■ See intended use ■ Application of Phynox clips ■ All applications which are not part of the intended use ■ With known material intolerances

Medical or surgical conditions (e.g. comorbidities), individually or combined, which could hinder the success of the operation. Use of the products requires individual, critical assessment by the surgeon.

6.

Risks, adverse effects and interactions

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. Possible risks, side effects and interactions of the application currently known to the manufacturer are: ■ Undesired damage to surrounding tissue resulting in bleeding ■ Infection ■ Material intolerances ■ Unintended use of instrument components ■ Disruptions to wound healing as well as other types of surgical complications ■ Loss of clip ■ Clip damage

7.

Applications

7.1

Documentation

The surgeon will create a surgery plan, which includes the selection and dimensioning of the clip as well as the slim clip applier. The following points are to be considered before use: ► Read, follow, and keep the instructions for use. ► Use the product only in applications according to its intended use, see Chapter 2.

7.2

Product

► Clean and disinfect 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.

CAUTION

Damage to, imprecise functioning and incorrect closing force of the aneurysm clips caused by using the wrong applier forceps! ► Use aneurysm clips only with the matching applier forceps; note the respective color of the color-coding button.

8.2

Product

► Do not use damaged slim clip applier or aneurysm clips.

In order to prevent damage to the slim clip applier and aneurysm clip: ► Do not use the clip applier as a clamp. ► Handle the clip applier and aneurysm clips with due care. ► Avoid manual and/or mechanical manipulation of the clip applier. ► Never open aneurysm clips with your fingers. Note Excessive, rough or repeated handling, especially opening and closing of aneurysm clips, be it in general use or during cleaning and sterilization, can change the closing force and impair the clinical effectiveness of the aneurysm clips.

9.

Validated reprocessing procedure

9.1

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 validation of the reprocessing method. The operator/reprocessing technician is responsible for this. The specified chemistry was used for validation. Note For up-to-date information about 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.

9.2

General information

Mechanical alkaline cleaning and thermal disinfection

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and reprocessing should not exceed 1 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. 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. 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 further detailed information on hygienically safe and material-preserving/value-preserving reprocessing, see www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

9.3 Limitations on reuse ■ The product can be reused up to 500 times if undamaged and used with proper care. Any additional reuse falls

Machine type: Single-chamber cleaning/disinfecting machine without ultrasound1) Phase

Step

D [°C/°F]

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

Dr. Weigert neodisher® SeptoClean 1 %2) working solution

III

Intermediate rinse

>10/50

1

FD–W

-

IV

Second intermediate rinse

>10/50

1

FD–W

–

V

Thermal disinfection

90/194

5

FD–W

-

VI

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

D–W: FD–W:

t [min]

Water quality

Chemicals

Drinking water Fully desalinated water To demonstrate the cleanability, the following cleaning and disinfecting machine was used: Miele 7836 CD Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean)

1)

under the responsibility of the user.

■ The life of the product is limited by damage, normal wear and tear, type and duration of use, as well as handling,

2)

storage and transport of the product. ■ A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional. ■ The biological compatibility of the product may be affected by the accumulation of cleanser residues. Monitoring this is the responsibility of the user.

► Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots) ► Place instruments in the tray with their hinges open. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

9.4

9.8

Disassembling the product before carrying out the reprocessing procedure

Inspection, maintenance and checks

► Open up products with hinges.

9.5

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.

CAUTION

► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Put the wet product into a closed disposal container and have it transferred to cleaning and disinfecting within

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).

1 h.

9.6

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

Cleaning/disinfection

free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components).

Product-specific safety notes on the reprocessing procedure Danger to the patient! ► Reprocess the product only with manual pre-cleaning followed by mechanical cleaning.

► If necessary, dry product with a lint-free single use cloth and/or medical compressed air. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see

Chapter 13. ► Check for compatibility with associated products.

DANGER

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

in Aesculap sterile containers).

DANGER

CAUTION

► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants according to the manufacturer's instructions. ► 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. ► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids. ► Do not use oxidizing process chemicals (e.g. H2O2), as these can cause bleaching or layer loss.

9.7

Packaging

► Appropriately protect products with fine working tips. ► Place the product in its holder or on a suitable tray. ► Pack the trays suitable for the sterilization process in sterile packaging that complies with EN ISO 11607-1 (e.g.

Mechanical cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfecting machine must be of tested and approved effectiveness (e.g. meets the requirements of EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.

Manual pre-cleaning with a brush Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Cleaning

RT (cold)

>15

1

D–W

Dr. Weigert neodisher® SeptoClean*

II

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean)

9.10 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 EN 285 and validated according to EN ISO 17665 – Sterilization using fractional vacuum process at 134 °C, holding time 18 minutes for prion inactivation ► When sterilizing several products 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.

9.11 Sterilization for the US market ■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. ■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc. WARNING for the US market If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of crosscontamination.

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

10.

Product properties

Phase I ► Fully immerse the product in the cleaning/disinfecting solution for at least 15 minutes. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed. ► If applicable, brush non-visible surfaces for at least 1 minute with a suitable cleaning brush. ► 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).

The slim clip applier is laser marked in the shaft region and has a colored marking pin on the branches, see Chapter 7.2. The suitable aneurysm clips are also labeled with the same color coding. For further information and suitable aneurysm clips, please contact Aesculap. The slim clip applier is made of stainless steel pursuant to EN ISO 7153-1. In addition to a slimmer design, the Noir® coating (AlTiN) is applied to the slim clip applier for improved view. For orders or detailed information regarding certain models of the slim clip applier, please contact your national B. Braun/Aesculap representative.

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.

Note If the slim clip applier is damaged (such as through bending the lock or the branches or if there is damage to the coating), the product may no longer be used and must be separated immediately.

11.

Available sizes

All slim clip appliers are marked according to size (Mini or Standard) and clip material (titanium) so that their correct application with aneurysm clips of the respective size and material is ensured.

12.

Disposal

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

13.

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

► 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] Or in the US: Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Other service addresses can be obtained from the address indicated above.

14.

Distributor in the US/Contact in Canada for product information and complaints

Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TATA015002

2019-01

V6

Change No. 59148