Storage and reprocessing tray for aneurysm clips

en

2.2.2 ®

Aesculap Storage and reprocessing tray for aneurysm clips

2.2.3

Legend 1 Storage and reprocessing tray for aneurysm clips, small FT008R 2 Storage and reprocessing tray for aneurysm clips, large FT009R 3 Lock 4 Lid 5 Tab on cover 6 Slot on storage and reprocessing tray 7 Compartment for clip storage 8 Slot for attaching identification tags 9 Partition, long 10 Partition, short 11 Identification tag 12 Tab on identification tag

1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

Product

Product-specific safety information Note The trays can be stacked in sterile containers. The stacking capability was tested for up to three layers.

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

2.3

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product.

2.3.1

Closing/opening the cover

Open the cover ► Push lock 3 downward and into “open” position, see Fig. A. ► Lift cover 4 in front (step a) and then push backward (step b), see Fig. B. ► Remove cover 4 upward from tray. Close the cover ► Set cover 4 slightly skewed on tray and guide tab 5 into slot 6, see Fig. C. ► Fold down cover 4. ► Push lock 3 downward and into "closed" position, see Fig. A.

2.3.2

Define allocation of compartments

These instructions for use apply for the following products:

Each compartment 7 in the tray has a slot 8 for an identification tag, see Fig. D.

Art. no.

Designation

Note Compatible identification tags are available for every Aesculap Yasargil aneurysm clip and also without labeling.

FT008R

Storage and reprocessing tray for aneurysm clips, small

► Prior to loading with aneurysm clips for the first time, define the allocation of the compartments and supply each

FT009R

Storage and reprocessing tray for aneurysm clips, large

compartment with an identification tag. ► According to the defined allocation, remove/relocate compartment partitions 9/10:

– Pull out partition 9/10 (step c) and pull retainer tab out of the tray slot (step d), see Fig. E. – Insert new partition 9/10 with the retainer tab into the tray slot (step e) and then press down to latch (step f), see Fig. F.

► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun

eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result.

Note Certain long clips require a long compartment, which is created by removing/relocating the partitions. The large identification tag indicates the necessity for a large compartment. ► Insert identification tags 11 into the slots 8 according to the defined allocation, see Fig. G. To do so, first insert

identification tag into the lower recess (step g) and latch by pressing into the upper recess (step h). ► To remove identification tags: push identification tag 11 upward on tab 12, see Fig. H.

WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

2.3.3

CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

► Before loading with aneurysm clips, mechanically clean the tray with the identification tags, see Validated repro-

Load tray for aneurysm clips

The user is responsible for the proper handling of the product. ► Follow the instructions for use of the aneurysm clips. cessing procedure.

2.

Clinical use

► Carefully sort the aneurysm clips into the appropriate compartments 7, according to the identification tags.

2.1

Areas of use and limitations of use

Note A maximum of five aneurysm clips can be placed in one compartment.

2.1.1

Available sizes

Art. no.

Designation

FT008R

Storage and reprocessing tray for aneurysm clips, small

FT009R

Storage and reprocessing tray for aneurysm clips, large

► Always close the cover before transporting the loaded tray. ► When placing the cover, ensure that the cover closes correctly and no aneurysm clips become clamped or are

otherwise damaged.

2.1.2

General notes

In the following text, "Storage and reprocessing tray for aneurysm clips" are referred to as "tray".

2.1.3

Intended use

The Aesculap storage and reprocessing tray for aneurysm clips is intended exclusively for the organization, storage and transport of Aesculap Yasargil aneurysm clips. The purpose of the aneurysm clips is described in the respective instructions for use.

2.1.4

Indications

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

2.1.5

Absolute contraindications

No known absolute contraindications.

2.1.6

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) which could hinder the success of the operation. In the presence of relative contraindications, the user decides individually regarding the use of the product.

2.2

Safety information

2.2.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

3.

Validated reprocessing procedure

WARNING Reprocessing danger! The reprocessing procedure described below applies only for the initial cleaning of a new product. ► Observe the instructions concerning cleaning/disinfection of the aneurysm clips, according to the instructions for use of the aneurysm clips.

3.1

General safety instructions

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/reprocessor is responsible for this. The recommended chemical was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. 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.

3.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. 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 in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. 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 of 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 surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.ak-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.4

Mechanical alkaline cleaning and thermal disinfection

Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

D [°C/°F]

t [min]

Water quality

Chemistry

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

Dr. Weigert neodisher® SeptoClean application solution 1 %*

III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD–W

-

V

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 ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.5

Inspection

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.5.1

Visual inspection

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical service.

3.5.2

Functional test

► Check that the product functions correctly. ► Check that all moving parts are working properly (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.6

Packaging

► Ensure that the aneurysm clips are sorted into the correct compartments 7 according to size, shape and article

number. ► Under all circumstances, observe the inscription on the identification tags. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.7

Steam sterilization

► Sterilize according to the instructions for use of the aneurysm clips.

3.8

Storage

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

4.

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

5.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. WARNING Risk of injury due to sharp-edged and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents injury by the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA015391

2020-03

V6

Change No. 62414