TA013786 Aesculap Dissecting Forceps Instructions

Scope
This user manual applies to standard forceps without transmission or catch pins.
Note:
The valid CE marking for the product can be seen on the label or packaging of the product. For product-specific instructions and information on material compatibility and product lifespan, refer to B. Braun eIFU at eifu.bbraun.com.

Warnings
WARNING: Indicates a potential imminent danger. Failure to avoid it may result in minor or severe injuries.

Clinical Use
Areas of Application and Application Restriction
The forceps are used for grasping and holding organs and/or tissue and/or blood vessels and/or medical accessories.

Indications
Note:
Use of the product outside the specified indications and/or described applications is beyond the manufacturer’s responsibility. For indications, refer to Intended Use.
Contraindications
No contraindications are known.

Instructions for use/Technical description
Forceps
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.aesculapusa.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.

Forceps
About this document
- Note
  General risk factors associated with surgical procedures are not described in these instructions for use.

Scope
- Note
- The applicable CE mark for the product can be seen on the label or packaging of the product.
- For article-specific instructions for use material compatibility and lifetime information, 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 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.

Clinical use

Areas of use and limitations of use

Intended use
The forceps are used to pick up and hold organs and/or tissue and/or vessels and/or medical accessories.
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.
Contraindications
Currently no known contraindications.

Clinical User General Safety Instructions:

Use this product strictly according to these instructions.
Follow the safety information and maintenance instructions.
Allow only persons with the required training, knowledge, and experience to use the product and accessories.
Store new or unused products in a dry, clean, and safe place.
Check the proper operation and condition of the product before use.
Keep this user manual accessible to the user.
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.
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 information

Note

Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products.

Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
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.
If there is no final sterilization, then a virucidal disinfectant must be used.

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.a-k-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 agents and disinfectants by the manufacturer’s instructions,
Observe specifications regarding concentration, temperature, and exposure time.

Do not exceed the maximum allowable disinfection temperature of 95 °C.

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush

■ Disposable syringe 20 ml

■ 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).

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfection

Manual cleaning/disinfection

Before 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, low microbiological contamination: drinking water quality at least)
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).
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
Mechanical alkaline cleaning and thermal disinfection
Machine type: single-chamber cleaning/disinfection device without ultrasound

Phase	Step	T [°C/°F]	t [min]	Water quality	Chemical/Note
I	Pre-rinse	<25/77	3	D–W	–
II	Cleaning	55/131	10	FD-W	■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant ■ 0.5 % working solution – 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

D–W: Drinking water

FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
Recommended: BBraun Helimatic Cleaner Alcaline
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.

Visual inspection

Make sure all contamination has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed areas, drilled grooves, and the like.
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 TechnicalServicee.

Functional test

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 TechnicalServicee.

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 in fractionated vacuum process
Steam sterilizer by DIN EN 285 and validated by DIN EN ISO 17665
Sterilization in 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 injurytoy the product.

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

TA013786
2020-09
V6
Change No. 63358

Frequently Asked Questions

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 our website at www.aesculapusa.com. If you require a paper copy, please contact your local Aesculap representative or Aesculap’s customer service at 1-800-282-9000 for a free copy upon request.

Documents / Resources

Aesculap TA013786 Aesculap Dissecting Forceps [pdf] Instructions
TA013786, M39160NL, TA013786 Aesculap Dissecting Forceps, TA013786, Aesculap Dissecting Forceps, Dissecting Forceps, Forceps

References

User Manual

TA013786 Aesculap Dissecting Forceps

Specifications

Product Usage Instructions