Wire saw system

en AESCULAP® Wire saw system 1.

About this document

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

1.1

Scope

These instructions for use apply to the following products:

Single-use products Art. no.

Designation

FH403 to FH405, FH407, FH413 to FH415, FH430R

Wire saws

The product is intended for single-use. ► Do not reuse the product.

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.

Art. no.

Designation

FH403

Olivecrona wire saw ∅ 1,2 mm, length 300 mm

► Introduce the wire saw with the help of the guide probe FF130R. Introduce the guide probe with the thick

FH404

Olivecrona wire saw ∅ 1,2 mm, length 400 mm

► Once introduced, connect the wire saw to two handles FH480R.

FH405

Olivecrona wire saw ∅ 1,2 mm, length 500 mm

FH407

Olivecrona wire saw ∅ 1,2 mm, length 700 mm

FH413

Gigli wire saw ∅ 1,4 mm, length 300 mm

FH414

Gigli wire saw ∅ 1,4 mm, length 400 mm

FH415

Gigli wire saw ∅ 1,4 mm, length 500 mm

FH430R

Gigli wire saw ∅ 1,8 mm, length 500 mm

FF130R

De Martel guide probe for wire saw

FH480R

Hook handle for wire saws

Note Instructions for use and further information about B. Braun / AESCULAP products can be found on the B. Braun eIFU website 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: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

Note The summary of safety and clinical performance of the product is available in the European database on medical devices (EUDAMED).

2.1

Areas of use and limitations of use

2.1.1

Intended use

The wire saw system is used to cut bone and hard tissue in various surgical disciplines, such as to open the skull in neurosurgery.

2.1.2

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.

2.1.3

Contraindications

end first and with the hook facing the direction of the bone to be cut. The wire saw can now be moved between the bone and the guide probe. The guide probe serves as a protector.

3.

Validated processing procedure

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 processing of products. Note Mechanical processing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. Note Up-to-date information about processing and material compatibility can be found on the B. Braun eIFU site 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 precleaning 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.a-k-i.org, link to "AKI-Brochures", "Red brochure".

No known contraindications.

3.3

2.2

Safety information

Art. no.

Designation

2.2.1

Clinical user

FH403 to FH405, FH407, FH413 to FH415, FH430R

Wire saws

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.

The product is intended for single-use. ► Do not reuse the product. Intraoperative contamination with blood, secretions, and other fluids may render the affected component unsuitable for resterilization. ► Handle the products with new gloves only. ► Keep the product storage trays covered or closed. ► Do not process clean products/trays together with contaminated products/trays. ► Process the products individually and separately if no storage trays are available, When doing this, make certain that the products are not damaged. ► Do not reuse surgically contaminated products. Note Unused wire saws can be repeatedly reprocessed.

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.

3.4

2.2.2

3.5

Product

Product-specific safety information ► Only combine Aesculap products with each other. ► Always adhere to applicable standards. ► Only use the product under vision.

2.2.3

Sterility

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

Single-use products

Service life

Influences of the processing using the validated procedure 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.

Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for

example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

3.6

Preparing for cleaning

► Unhook handles FH480R from the wire saw.

3.7

Cleaning/Disinfection

3.7.1

Product-specific safety information on the processing method

3.9.1

Danger to the patient! The product must not be manually reprocessed. ► Process wire saws and guide probe FF130R only in a mechanical washer/disinfector. Risk to patient due to cross contamination! ► Do not use contaminated products that have already been used in the CNS in other areas unless they have been cleaned with an alkaline cleaner (pH ≈ 11). Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

3.7.2

Validated cleaning and disinfection procedure

Note Processing may only take place in accordance with the following listed procedures in version V6. These are documented in the brochure “Validated Reprocessing Procedures” (AVA-V6) C63402. You will also find this brochure on the B. Braun eIFU site at eifu.bbraun.com Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

► Use a suitable cleaning brush. ► Use a disposable syringe 20 ml. ► Drying phase: Use a lint-free cloth or

Chapter Manual cleaning/disinfecting and subsection:

■ Hook handle for wire saws FH480R

medical compressed air.

■ Chapter Manual cleaning with immersion disinfection

Mechanical alkaline cleaning and thermal disinfection

► Place the product on a tray that is suit-

able for cleaning (avoid rinsing blind spots).

■ All products

the disinfectant.

3.8.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ≈ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ≈ 9*

V

Drying

1

RT

-

-

FD-W

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH ≈ 13 – < 5 % anionic surfactant

■ working solution 0.5% – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

DW: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: B. Braun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.10 Inspection

3.10.1 Visual inspection

► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfecting process if necessary.

RT (cold)

T [°C/°F]

■ Chapter Mechanical

Manual cleaning/disinfecting

Final rinse

Step

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

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of

IV

Phase

Chapter Mechanical cleaning/disinfection and subsection: alkaline cleaning and thermal disinfecting

3.8

► 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 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

Technical service.

3.10.2 Functional test

-

► Assemble disassembled products. ► Check that the product functions correctly. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical

service.

3.11 Packaging ► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► 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 stor-

age.

3.12 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). ► Use validated sterilization process:

-

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature *Recommended: B. Braun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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

disinfection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. 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 from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

3.9

Mechanical alkaline cleaning and thermal disinfecting

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

Mechanical cleaning/disinfection

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. compliance with EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

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. Note The user institution is obliged to reprocess the product before its disposal, see Validated processing procedure. TA013276

2022-05

Change No. AE0061706