Noir – Modular instrument system

en ®

®

Aesculap Noir Modular instrument system Legend 1 2 3 4 5 6 7

Handle: fixed handle part Handle: moving handle part Shaft Marking work length Handle Lock nut Shaft holder

1.

About this document

2.3

Safety information

2.3.1

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.

These instructions for use apply for the following products:

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.

Art. no.

Designation

2.3.2

FD797B to FD799B

Noir® Probe, ball-tip

► Only combine Aesculap products with each other. ► Always adhere to applicable standards.

FD805B

Noir® Hook, sharp

2.3.3

FD808B/FD809B

Noir® Hook, blunt

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

FD811B/FD812B

Noir® handle modular

2.4

FD814B to FD816B

Noir® Scoops

FD818B/FD819B

Noir® handle modular bayonet

FD821B to FD823B

Noir® Dissector

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. ► Ensure that the clamped shaft is locked in place. ► Pay attention to any pointed and sharp tips on the shaft. ► Observe the “min” and “max” markings on the shaft. Uncontrolled movements of the shaft may occur outside of that range.

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

1.1

Scope

Product-specific safety information

Sterility

Application

FD824B to FD828B

Noir® Curette 4mm

FD831B to FD833B

Noir® Raspatory

FD835B/FD836B

Noir® Curette 6.5 mm

3.

Validated reprocessing procedure

FD839B to FD841B

Noir® Tumor Knife

3.1

General safety information

FD848B/FD849B

Noir® handle modular high bayonet

► For article specific instructions for use and material compatibility and lifetime information, 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: WARNING Indicates a possible hazard. 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

2.1 Available sizes ■ Different handle shapes ■ Different handle diameters ■ Shafts having different tips Note Detailed information on available models and sizes is described in the Aesculap brochures.

2.2

Areas of use and limitations of use

2.2.1

Intended use

The modular instrument system is used for microsurgical procedures in all surgical disciplines. Modular handles Different shafts of different lengths and positions can be clamped into the modular handles. One handle can be used for several shafts/tips. Probe ball-tip/Hook Blunt hooks are intended for holding/grasping and retracting tissue/vessels/nerves. Scoops Scoops are intended for removing septic bone parts, scraping periosteum, and working on fracture edges. They are also used for removing cancellous bone. Dissectors Dissectors are intended for blunt dissection between bone and tissue or different tissues. Curettes Curettes are used to remove septic bone parts, to bevel edges of fractures, and to remove periosteum. They are also used to eliminate unevenness or to skim the vertebral endplates to create an implant site that is as level and perfectly prepared as possible. Raspatories Raspatories are used to remove septic bone parts, to bevel edges of fractures and to remove periosteum. Tumor knife Micro knives are thin knives used to precisely cut / excise / prepare tumors and various vessels / tissues / nerves during microsurgical procedures.

2.2.2

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.

2.2.3

Contraindications

No known contraindications.

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.

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.a-k-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Reusable products

There are no known effects of reprocessing resulting in damage to the product. Careful visual and functional inspection before the next use is the best opportunity to identify 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

Preparing for cleaning

► Do not disassemble fixation screws which permanently connect the various components. ► Disassemble the product prior to cleaning, see Disassembly. ► Open up product with hinges.

3.6

Disassembly

3.6.1

Straight handles FD811B/FD812B

► Slightly unscrew the fixed handle part 1 and the movable handle part 2. ► Remove shaft 3 from the handle 5 from the front, see Fig. 1. ► Completely unscrew the fixed handle part 1 and the movable handle part 2, see Fig. 3.

3.6.2

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.

Bayonet handles FD818B/FD819B/FD848B/FD849B:

► Unscrew lock nut 6. ► Pull shaft 3 out of shaft holder 7, see Fig. 5. ► Continue to unscrew the lock nut 6 until the thread is no longer engaged.

3.9

3.7

Cleaning/Disinfection

3.7.1

Product-specific safety information on the reprocessing method

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).

Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants in accordance with the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

For products with plasma layers (e.g. Noir Instruments), the layer can become damaged or worn if special cleaning procedures based on oxidizing chemicals (e.g. hydrogen peroxide H2O2) are used. ► Do not use oxidizing chemicals for cleaning.

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. ► If the microsurgical products can be securely fixed in machines or storage devices in such a way that they will be cleaned thoroughly, clean and disinfect them mechanically.

3.7.2

3.9.1

Mechanical alkaline cleaning and thermal disinfection

Machine type: single-chamber cleaning/disinfection device without ultrasound

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Manual cleaning with immersion disinfection

– pH = 11* Reference

■ Cleaning brush, for example TA011204

■ Single-use syringe 20ml ■ Drying phase: Use a lint-free

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with immersion disinfection

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

cloth or medical compressed air 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

All except FB811B, FB812B– FB818B, FB819B, FB848B, FB849B

cleaning and thermal disinfection

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ Cleaning brush, for example

Applies to FB811B, FB812B– FB818B, FB819B, FB848B, FB849B

is suitable for cleaning (avoid rinsing blind spots).

3.8

TA011204

■ Single-use syringe 20ml ■ Place the product on a tray that

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Manual cleaning/disinfection

D–W: FD–W:

Drinking water 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.

3.10 Mechanical cleaning/disinfection with manual pre-cleaning 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.

3.10.1 Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfectant cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

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

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

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*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure.

D–W: FD–W:

Drinking water 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 dis-

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.

3.10.2 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound

infection 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

Step

T [°C/°F]

t [min]

Water quality

Chemical

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

-

-

-

In accordance with the program for the cleaning and disinfecting machine

D–W: FD–W:

Drinking water 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.

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

3.11.1 Visual inspection ► Make sure all contamination has been removed. Pay particular attention to shafts, indentations, etc. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check product for damage, such as corroded, loose, bent, broken, cracked, worn, heavily scratched or missing

parts. ► Check the product for missing or faded labels. ► Check products having long, narrow geometries for deformations. ► 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.

3.11.2 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). ► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working property (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.

3.12 Assembly 3.12.1 Straight handles FD811B/FD812B ► Screw the fixed handle part 1 to the movable handle part 2 almost all the way to the stop, see Fig. 3. ► Insert the shaft 3 into the handle 5, see Fig. 1. ► If the shaft 3 cannot be inserted into handle 5: Slightly loosen the screw connection of the fixed handle part 1

and the movable handle part 2. ► Set the working length according to the marking working length 4, see Fig. 2. ► Lock the shaft 3 in place. To this end, screw the moving handle part 2 onto the fixed handle part 1 until there is

a palpable resistance, see Fig. 4.

3.12.2 Bayonet handles FD818B/FD819B/FD848B/FD849B: ► Screw the lock nut 6 onto the threads of the shaft holder 7 but do not tighten.

Note Lock nut 6 may not be screwed tight without shaft 3. ► Insert shaft 3 into shaft holder 7, see Fig. 5. ► Set the working length according to the marking working length 4. ► Lock the shaft 3 in place. For this purpose, screw the lock nut 6 onto the shaft holder 7 until there is a palpable

resistance.

3.13 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.

3.14 Steam sterilization Note The straight handles FD811B/FD812B can be sterilized either in disassembled or in assembled condition. ► 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 in accordance with DIN EN 285 and validated in accordance with 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.

3.15 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 required to reprocess the product before its disposal, see Validated reprocessing procedure. TA014014

2020-03

V6

Change No. 61036