Noir Micro Instruments

en ®

Aesculap Noir® Micro Instruments 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: Art. no.

Name

FD493B to FD495B

Micro-needle holder

FD481B to FD485B

Micro-scissors

FD488B to FD490B

Micro-tweezers, straight

FD510B to FD511B

Micro-tweezers, curved tip

► 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 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 on the safety and clinical performance of the product is available in the European Medical Devices Database (EUDAMED).

2.1

Areas of use and limitations of use

2.1.1

Intended use

These Noir® Micro instruments include scissors, forceps and needle holders. They are used especially for performing micro anastomosis in case of cerebrovascular diseases (central nervous system). Scissors are used for cutting and/or dissecting tissue and/or vessels. Forceps are used for grasping and holding of organs and/or tissue and/or vessels and for spreading of tissue. Needle holders are used for grasping, holding and guiding surgical suture needles and surgical suture material.

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.

Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.aesculap-extra.net The validated steam sterilization procedure was performed using the Aesculap sterile container system.

3.2

General notes

Dried and hardened or retained surgical residues can make cleaning difficult or ineffective and cause corrosion. Therefore, do not exceed a period of 1 hour between use and processing, make sure pre-cleaning temperatures are >45°C to avoid clotting, and do not use disinfectants that can cause clotting (active ingredient basis: aldehyde, alcohol). Using too much neutralizing agent or basic cleaner or very highly concentrated scents/cleaners may cause chemical corrosion and/or fading, and on stainless steel the laser marking may become unreadable, either visually or for the machine. On stainless steel, residues containing chlorine or chloride (such as surgical residues, drugs, saline solutions in water for cleaning purposes, disinfection and sterilization) may cause corrosion (pitting corrosion, stress corrosion) and eventually the destruction of the product. To remove such residues, rinse thoroughly using demineralized water and then dry. Perform additional drying, if necessary. Only use process chemicals that have been tested and approved (e.g. VAH or FDA approval, or have a CE mark) and are recommended by the manufacturer of the chemicals as being compatible with the materials. Strictly adhere to any and all directions for use of the manufacturer of the chemicals. Failure to do so can result in the problems listed below: ■ 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 surface 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

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.

3.4

Preparation at the place of use

► If applicable, rinse surfaces that are not accessible to visible inspection, preferably using demineralized water –

for example, disposable syringes. ► Remove any visible surgical residues as fat as possible using a damp, lint-free cloth. ► Put the wet product into a closed disposal container and have it transferred to a cleaning and disinfecting loca-

tion within 1 h.

3.5

Cleaning/Disinfection

3.5.1

Product-specific safety information on the reprocessing method

Hazardous for patients! ► Only reprocess the product using machine cleaning. Risk to patients from cross contamination! ► Do not clean contaminated products which have already been used in the CNS – together with clean products in the same cleaning container, – and do not use them in other areas unless they have been cleaned using alkaline detergent (pH ~ 11). Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants 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.

No known contraindications.

For products having plasma layers (e.g. Noir instruments), the layer is attacked or worn when using special cleaning procedures containing oxidizing chemicals (e.g. hydrogen peroxide H2O2). ► Do not use oxidizing chemicals for cleaning.

2.2

Safety information

3.6

2.2.1

Clinical user

Note The cleaning and disinfection device used must have proof of effectiveness (e.g. fulfill EN ISO 15883).

2.1.3

Contraindications

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 cleaning and disinfection device used for processing must be serviced and tested at regular intervals. Type of device: Single-chamber cleaning/disinfection device without ultrasound1)

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.

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.

3.

Validated reprocessing procedure

3.1

General safety instructions

Note Observe national statutory regulations, national and international standards and directives, and any local, clinical hygiene instructions for reprocessing. Note For patients having Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, the applicable national regulations concerning the reprocessing of devices must be observed. Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessor is responsible for this. The specified chemical agents were used for validation purposes.

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

DI-W

Alkaline cleaning agent Working solution pH ~ 112)

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

Alkaline machine cleaning and thermal disinfection

III

Neutralization3)

>10/50

2

DI-W

B. Braun Helimatic® Neutralizer C Working solution 0.15 %

IV

Intermediate rinse I

>10/50

1

DI-W

-

V

Intermediate rinse II3)

>10/50

1

DI-W

-

VI

Thermal disinfection

90/194

5

DI-W

-

VII

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting device

DW: DI–W: 1) 2) 3)

Drinking water Deionized water To demonstrate the cleanability, the following cleaning and disinfecting machine was used: Miele PG 8535 Dr. Weigert neodisher® SeptoClean was used to prove cleanability. Due to the high pH value of the purifier, neutralization and the second intermediate rinse were used.

► Place product on screen basket suitable for cleaning (make sure there are no areas not reached by the water jets). ► Open the links and joints before placing the product on the sterilization tray. ► 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. ► 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.). ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.8

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 storage.

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). ► Validated sterilization process

– Steam sterilization in fractionated vacuum process – Steam sterilizer in accordance with DIN EN285 and validated in accordance with DIN EN ISO17665 – Sterilization in fractionated vacuum process at 134 °C, holding time 5 min Note The product is also suitable for sterilization at 134 °C, holding time 18 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.

3.10 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 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 from sharp and/or pointed products! ► When disposing of or recycling the product, make sure the packaging prevents injury from the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA015757

2020-07

V6

Change No. 63250