Temporary YASARGIL Phynox aneurysm clips

en AESCULAP® Temporary YASARGIL Phynox aneurysm clips

Safety advice

Legend

– Wrong indication or product selection – incorrect surgical technique – Incorrect combination of product components, particularly combinations with components of other manufacturers – Exceeding the limitations of the treatment method or non-observance of essential medical precautions ■ The user is required to obtain information from the manufacturer if there is an ambiguous preoperative situation regarding the use of the relevant products.

1 2 3 4 5 A B C

YASARGIL aneurysm clip, example of a straight clip YASARGIL aneurysm clip, correctly positioned YASARGIL aneurysm clip, incorrectly positioned YASARGIL aneurysm clip, incorrectly positioned YASARGIL aneurysm clip, incorrectly positioned Test point Force Length of the jaw part

General information

■ In the following text, “temporary Aesculap YASARGIL Phynox aneurysm clips" are referred to as "aneurysm clips" or "clips”.

■ General risk factors associated with surgical procedures are not described in this documentation.

Intended use The temporary aneurysm clips are intended for the temporary ligation of aneurysms or blood vessels. The temporary aneurysm clips are intended for multiple use and can be used repeatedly.

Indications

■ Cerebral aneurysms ■ Cerebral blood vessels

Absolute contraindications Temporary aneurysm clips are contraindicated for the following applications: ■ Permanent prevention of cerebral aneurysms ■ All areas of application not listed under the indications ► Do not use if the patient is known to be sensitive to foreign substances in product materials.

Relative contraindications The following conditions, individual or combined, can lead to delayed healing or compromise the success of the operation: medical or surgical conditions (e.g. comorbidities) that could impede the success of the operation.

Risks, adverse effects and interactions The following possible side-effects and interactions are referred to in the framework of the legal informational obligation: ■ Infections ■ Sensitization to the clip materials ■ Nerve lesions ■ Vascular injuries with the possible consequence of hematoma or bleeding ■ Organ and other tissue injuries ■ Disruptions to wound healing as well as other types of surgical complications. The application of aneurysm clips involves the following severe risks: ■ Scissoring of the jaw parts ■ Rupture of the aneurysm due to perforation, incomplete fitting of the clip jaw on the neck of the aneurysm. ■ Reduction of the vessel cross-section because the clip is placed near the vessel periphery in the case of large aneurysms ■ Cerebrovascular spasms and sudden death

Application Documentation The operating surgeon shall devise an operation plan that specifies and accurately documents the following: ■ Selection of the clips and their dimensions ■ Location of intraoperative landmarks Each patient must be informed comprehensively about the properties of aneurysm clips, as well as about the surgical procedure.

Product CAUTION Damage to the clip due to incorrect handling, restriction of the functionality and changing of the closing force! ► Only remove clips from their sterile packaging or storage for application. ► Only remove and apply with the appropriate Aesculap applying clips for aneurysm clips. ► The clip must never be manipulated with the fingers. ► Discard clips that appear changed or show signs of damage, (e.g. incorrect position of the jaws, bent parts or discolorations). ► Remove clips from double sterile packaging or make ready in the storage system. ► 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. Immediately discard any damaged products. ► Carefully grip using the Aesculap applying forceps for aneurysm clips and remove, see Fig. 2. In doing so,

ensure that the clip is not gripped as shown in Fig. 3/4/5 and observe the following points: – Clips must be used only with the appropriate size of applying or removing forceps (Mini or Standard). – Phynox clips must only be used with Aesculap applying forceps for Phynox aneurysm clips. – Applying or removing forceps supplied by other manufacturers must not be used. ► Apply the clip. When doing so, ensure that the occlusion of the aneurysm or vessel is achieved. ► Check the position of the clip and correct if necessary. ► If necessary, insert additional clips. DANGER Risk to patient due to permanently implanted temporary aneurysm clips! ► Do not under any circumstances permanently implant temporary aneurysm clips. ► Remove the temporary aneurysm clips again after use.

Users ■ 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:

Product ► Do not use damaged clips. ► To avoid damage to the aneurysm clips:

– Always treat the aneurysm clips with appropriate care. – Never open aneurysm clips with your fingers. – Avoid any manual and/or mechanical manipulation (e.g. with fingers or instruments) of the aneurysm clips. Excessive and rough 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. Interactions between MRI and YASARGIL aneurysm clips made of Phynox! ■ MRI examinations using magnetic fields of 1,5 and 3,0 tesla do not present an additional risk to patients. ■ Temporary aneurysm clips produce moderate MRI artifacts. Depending on the MR pulse frequency, the size of the artifacts can vary considerably. Note Stronger magnetic fields or an extension of the imaging area can lead to a significant increase in the incidence of positioning errors and artifacts. Aesculap cannot accept any responsibility for aneurysm clips that are handled inappropriately or not in accordance with the present instructions for use.

Sterility, cleaning and disinfection, storage ■ The clips are packed in individually labelled protective packaging. ■ The clips are gamma-sterilized. ► Store clips in their original packaging. Remove them from their original protective packaging only just prior

to application. ► Prior to use, check the product expiry date and verify the integrity of the sterile packaging. ► Do not prepare clips that are past their expiry date or whose packaging is damaged, see Validated repro-

cessing procedure. ► Ensure that the clips are not damaged in any way.

■ The product can be cleaned and sterilized up to 100 times if undamaged and used with proper care. Any additional reuse falls 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, storage and transport of the product.

■ A careful visual 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 task of the user. Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. 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 B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

Validated reprocessing procedure General notes Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. The clips should be kept moist for transport in order to avoid or limit as much as possible the drying out of potentially prion-containing organic residues. Do not use any fixing pre-cleaning temperatures >45 °C or fixing disinfectants (active ingredients: aldehydes/alcohols). 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: ■ 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 surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to "AKI-Brochures", "Red brochure".

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. ► Put the wet product into a closed disposal container and have it transferred to cleaning and disinfecting

within 1 h.

Manual cleaning/disinfection DANGER Danger to the patient! ► Only mechanically clean the product.

Mechanical cleaning/disinfection with ultrasonic pre-cleaning

Product description

Note It is essential that the cleaning and disinfection device used is officially recognized or certified as effective (e.g. fulfillment of EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

The aneurysm clips are available in following material: ■ Cobalt alloy (Phynox) according to ISO 5832-7 The aneurysm clips are available in two different sizes (Mini and Standard). Please contact Aesculap for more information and to order brochures on Phynox aneurysm clips. The aneurysm clips are color-coded as follows in order to differentiate between size and application.

Pre-cleaning with ultrasound

Designation

Size

Color-coded labelling

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

Temporary Phynox aneurysm clips

Mini Standard

Gold

I

Ultrasonic cleaning

RT (cold)

>15

1

D–W

Dr. Weigert neodisher® SeptoClean*

II

Rinsing

RT (cold)

1

-

D–W

-

Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.

Each aneurysm clip has an individual serial number. Each aneurysm clip has been packed and sterilized individually (dose min. 25 kGy). Each aneurysm clip in its original packaging is delivered in a double sterile packaging, together with instructions for use and labels. The closing force of each aneurysm clip is measured individually and is stated on the packaging. The closing force is measured at 1/3 of the length from the tip of the jaw part from the test point A in the middle of the contact surface. The Phynox aneurysm clips are measure with the jaw open to 0.5 mm, see Fig. 1. Note Permanent clips that are suitable for implantation are colored completely silver in order to distinguish them from temporary clips that are not suitable for implantation (Phynox clips). Applying and removing forceps for aneurysm clips are labeled by size (Mini, Standard or Long) and clip material (titanium, Phynox). For further information on appropriate applying and removal forceps, as well as for brochures for Phynox aneurysm clips, please contact Aesculap.

Mechanical alkaline cleaning and thermal disinfection

TA016208

D–W: Drinking water RT: Room temperature *Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean) Phase I ► Clean the product in an ultrasound cleaning bath (frequency of 35 kHz) for at least 15 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided.

Machine type: single-chamber cleaning/disinfection device without ultrasound 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 solution

III

Neutralization

>10/50

1

FD–W

Dr. Weigert neodisher® Z stock solution 0.1 %

IV

Intermediate rinse

>10/50

1

FD–W

-

V

Intermediate rinse

>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 FD–W: Fully desalinated water *Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean) ** The following cleaning and disinfection devices were used to verify cleanability: Miele 7836 CD ► Place the clips on the tray for aneurysm clips FT008R or FT009R (avoiding rinsing blind spots). When doing

so, place a maximum of 5 clips in one recess. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

Inspection and checking ► Check each individual clip. ► Discard and do not use clips that have the following features:

– Signs of damage – Incorrect jaw position – Bent components – Misalignment – Dirt Color coding may fade in the decontamination process. ► Discard and do not use clips if the color coding is no longer clearly visible.

Packaging ► Sort the product in the tray for aneurysm clips FT008R or FT009R. ► Package trays appropriately for the sterilization process in a sterile packaging conforming to EN

ISO 11607-1 (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during

storage.

Sterilization ► 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.

Storage ► Store the clips in their sterile packaging or in a tray for aneurysm clips FT008R or FT009R in a dust-free

area protected from chemical fumes and extreme air or temperature changes. For further information on the appropriate storage trays recommended by Aesculap, please contact Aesculap or consult the brochures for Phynox aneurysm clips. These brochures can also be ordered from Aesculap.

Disposal ► Adhere to national regulations when disposing of or recycling the product, its components and its pack-

aging.

2022-02