AESCULAP Surgical Scissors with Carbide Inserts Instruction Manual

: July 6, 2024
: Aesculap

Table of Contents

AESCULAP Surgical Scissors with Carbide Inserts
Product Information
Product Usage Instructions
FAQ
About this document
Clinical use
Safety information
Validated reprocessing procedure
Technical service
Documents / Resources

AESCULAP Surgical Scissors with Carbide Inserts

Specifications

Product: Surgical Scissors with Carbide Inserts
Manufacturer: Aesculap AG
Country of Origin: Germany
Model Number: TA016159
Year: 2021

Product Information

About this document

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

Scope

These instructions for use apply to surgical scissors with carbide inserts. For article-specific instructions for use as well as information on material compatibility and lifetime, visit B. Braun eIFU at eifu.bbraun.com.

Safety Messages

Safety messages make clear the dangers to the 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.

Product Usage Instructions

Clinical Use Areas of Use and Limitations of Use

Surgical Scissors: The instruments are used to cut tissue and/or medical materials and supplies.
Dissecting Scissors: The instruments are used to cut and/or dissect tissue.
Nail Scissors: The instruments are used to cut or split fingernails, toenails, and/or cuticles.
Bandage Scissors and Material Scissors: The instruments are used to cut medical materials and supplies and/or clothing.

Indications

Note: The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.
The instruments are used in a multitude of surgical procedures and interventions in almost all surgical disciplines.

FAQ

Q: Where can I obtain the Instructions for Use for United States users?

A: The Instructions for Use for United States users can be obtained by visiting the website at www.aesculapusaifus.com. You can also request a paper copy by contacting your local Aesculap representative or Aesculap’s customer service at 1-800-282-9000.

Instructions for use/Technical description

Surgical scissors with carbide inserts

USA Note for U.S. users

This Instructions for Use is NOT intended for United States users. Please discard. The Instructions for Use for United States users can be obtained by visiting our website at www.aesculapusaifus.com.
If you wish to obtain a paper copy of the Instructions for Use, you may request one by contacting your local Aesculap representative or Aesculap’s customer service at 1-800-282-9000.
A paper copy will be provided to you upon request at no additional cost.

About this document

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

Scope

These instructions for use apply to surgical scissors with carbide inserts.
For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com

Safety messages

Safety messages make clear the dangers to patients, users, and/or products that could arise during the use of the prod-uct.

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.

Clinical use

Areas of use and limitations of use

Intended use

Surgical scissors

The instruments are used to cut tissue and/or medical materials and supplies.

Dissecting scissors

The instruments are used to cut and/or dissect tissue.

Nail scissors

The instruments are used to cut or split fingernails toenails and/or cuticles.
Bandage scissors and material scissors
The instruments are used to cut medical materials supplies and/or clothing.

Indications

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.
The instruments are used in a multitude of surgical procedures and interventions in almost all surgical disciplines, see Intended Use.

Contraindications

No contraindications for the product are currently known.

Safety information

Clinical user General safety information

To prevent damage caused by improper setup or operation, and to not compromise the manufacturer’s 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.
Before 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.

Product-specific safety information

Note The product consists of metal alloys that contain cobalt.

Sterility

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

Application

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

Validated reprocessing procedure

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 Mechanical reprocessing 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 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.

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 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 destroy 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 manufacturer’s 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”.

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.

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.

Cleaning/Disinfection

Product-specific safety information on the reprocessing method 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.

Validated cleaning and disinfection procedure

Validated procedure	Specific requirements	Reference
Manual cleaning with immersion disinfection	■ Suitable cleaning brush

■ Disposable syringe 20 ml

■ Keep working ends open for cleaning.

■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

■ Drying phase: Use a lint-free cloth or medical compressed air

| Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with immersion disinfection

Mechanical alkaline cleaning and thermal disinfection| ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

■ Keep working ends open for cleaning.

■ Place the product on the tray with all product links and joints open.

| Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Manual cleaning/disinfection

Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the disinfecting solution.
After manual cleaning/disinfection, check visible surfaces visually for residues.
Repeat the cleaning/disinfection process if necessary.
Manual cleaning with immersion disinfection

Phase| Step| T [°C/°F]| t [min]| Conc. [%]| Water quality| Chemical
---|---|---|---|---|---|---
I| Disinfecting clean- ing| 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*
IV| Final rinse| RT

(cold)

| 1| –| FD-W| –
V| Drying| RT| –| –| –| –

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

Mechanical cleaning/disinfection

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).
Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

Mechanical alkaline cleaning and thermal disinfecting

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

Phase| Step| D [°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: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
Recommended: BBraun Helimatic Cleaner alkaline
Check visible surfaces for residues after mechanical cleaning/disinfecting.

Inspection

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

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 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.

Functional test

CAUTION Damage (metal cold welding/friction corrosion) to the product caused by insufficient lubrication!
Before 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 properly (e.g. hinges, locks/latches, sliding parts, etc.).
Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical Service.

Packaging

Appropriately protect products with fine working tips.
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 storage.

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 a 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.

Storage

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

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: ats@aesculap.de
Other service addresses can be obtained from the address indicated above.

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 to the product.
Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure.
TA016159 2021-09
Aesculap AG Am Aesculap-Platz 78532 Tuttlingen Germany
Phone +49 (0) 7461 95-0 Fax +49 (0) 7461 95-26 00www.bbraun.com
AESCULAP® – a B. Braun brand

Documents / Resources

| AESCULAP Surgical Scissors with Carbide Inserts [pdf] Instruction Manual
M39350EN, TA016159, Surgical Scissors with Carbide Inserts, Surgical Scissors, Scissors, Carbide Inserts, Inserts
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