Standard instruments for indications at the central nervous system

en AESCULAP® Standard instruments for indications at the central nervous 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 standard instruments for indications at the central nervous system. 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 (SSCP) of the product is available in the European database on medical devices (EUDAMED) at ec.europa.eu/tools/eudamed The SSCP can be found using the following Basic UDI-DI:

■ 40392390000015762Y ■ 40392390000017432T ■ 40392390000017442V ■ 40392390000017462Z ■ 403923900000174733

■ 40392390000017502Q ■ 40392390000017512S ■ 40392390000017522U ■ 40392390000017532W ■ 40392390000017542Y

2.1

Areas of use and limitations of use

2.1.1

Intended use

■ 403923900000175634 ■ 403923900000175736 ■ 40392390000017593A

The instruments are intended for the use in various surgical indications including the use at the central nervous system. Needle holders are used for grasping, holding and guiding surgical suture needles and surgical suture material. Scissors are used to cut and/or dissect tissue and/or vessels. Forceps are used for grasping and holding of organs and/or tissue and/or vessels and for spreading of tissue. Tumor grasping forceps are used for grasping or holding of organs or tissue. Spoons are used to manipulate and remove bone, bone-like structures, tissue as well as soft tissue. Elevators and dissectors are used to manipulate bone, bone-like structures, tissue as well as soft tissue. Raspatories are used to manipulate and remove bone, bone-like structures, tissue as well as soft tissue. Knives are used to cut tissue, organs, muscles, tumors, tendons, dura and fistula. Suture pushers are used to push and place surgical knots. Suture guides are used to connect surgical knots and adjust, hold and guide sutures. Micro hooks are used to hold tissues, nerves, organs and/or vessels. Dilators are used for expanding and widening vessels.

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

No known contraindications.

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.

2.2.2

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. ► Pay attention to the pointed and sharp working end. Note Excessive mechanical stress may cause deformation and/or fracture.

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 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".

3.3

Service life

Influences of the processing using the validated procedure which lead to damage to the product are not known. Careful visual and functional inspection before each use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.4

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.

3.5

Cleaning/Disinfection

3.5.1

Product-specific safety information on the reprocessing method

Danger to the patient! The product must not be manually processed. ► Process the product 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. For products with plasma layers (e.g. Noir instruments), the layer is attacked or removed when special cleaning procedures with the addition of oxidizing chemicals (e.g. hydrogen peroxide H2O2) are used. ► Do not use oxidizing chemicals for cleaning.

3.5.2

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

Mechanical alkaline cleaning and thermal disinfection

► Place the product on a tray that is suit-

Chapter Mechanical cleaning/disinfection and subsection:

3.6

able for cleaning (avoid rinsing blind spots). ► Place the product on the tray with all product links and joints open.

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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.

3.6.1

Mechanical alkaline cleaning and thermal disinfecting

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

Step

T [°C/°F]

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.

3.7

Inspection

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

3.7.1

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. ► If applicable, 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

Technical service.

3.7.2

Functional test

CAUTION Damage (metal cold welding / 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: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► If applicable, check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical

service.

3.8

Packaging

► Protect products with fine working tips appropriately. ► Store products with ratchet locks fully opened or locked no further than in the first notch. ► 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.

3.9

Steam sterilization

Note To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further than on the first ratchet tooth. ► 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: – 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. Note The material resistance of the products is not impaired by a sterilization temperature of up to 134 °C and/or a holding time of 18 minutes.

3.10 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 address 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 processing procedure. TA015902

2022-11

Change No. AE0061980