Aspiration and irrigation instruments

en

2.4 ®

AESCULAP Aspiration and irrigation instruments Legend 1 2 3 4 5 6

Suction tube, cylindrical/conical Holding area Suction interrupter, spherical/drop-shaped Tube connection Stylet Suction tube external diameter

1.

About this document

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

1.1

Scope

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. WARNING Risk of injury if the product is used outside the field of view! ► Only use the product with visual control. Note There is a danger of deformation and/or breakage due to excessive mechanical load.

2.4.1

Connecting aspiration and irrigation instruments

► Insert the appropriate tube into the tube connection 4 of the suction cannula. ► Connect the tube with a suitable surgical aspirator or irrigation system.

2.4.2

Regulate the suction power during the procedure

The operating surgeon can control the suction power via the suction cannula, e.g. to prevent suction on sensitive structures.

These usage instructions apply for the following products: aspiration and irrigation instruments ► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at eifu.bbraun.com

WARNING Risk of injury to the patient during the aspiration of fluids! ► Continuously control the aspiration process after the suction cannula has been inserted.

1.2

► Aspiration: Cover suction interruptor 3 on grip panel 2 with thumb. ► Non-aspiration: Remove thumb from suction interrupter 3 on grip panel 2. ► To adjust the suction power (for suction cannulas with a drop shaped suction interrupter): Partially cover suction

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

2.1

Available sizes

The aspiration and irrigation instruments are available with various: ■ Suction tube diameters ■ Working lengths ■ Total lengths ■ Holding area options ■ Suction controllers Detailed information about the available sizes/variants can be found in our brochures.

2.2

Areas of use and limitations of use

2.2.1

Intended use

Suction and irrigation tubes are used to suction bodily fluids, blood, tissues or secretions and for irrigation using irrigating solutions. The aspiration and irrigation instruments are specially suited for microsurgical interventions in neurosurgery and ENT surgery.

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.

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. 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.

2.3.2

Product-specific safety information

► Follow the instructions for use of the surgical aspirator or irrigation system.

2.3.3

Sterility

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

interrupter 3 on grip panel 2 according to the suction power required.

3.

Validated reprocessing procedure

3.1

General safety information

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. 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 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 chemistry was used for validation. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

General notes

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore, no more than 1 hours should be left between use and preparation, pre-clean temperatures >45 °C liable to fusing should not be employed and disinfectants liable to fusing (aldehyde or alcohol-based) should not be used. Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine in case of non 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 damage to the products in case of non stainless steel. These must be removed by rinsing thoroughly with demineralized water and then drying. Perform 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 reprocessing the product. All of the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be 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 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 option to determine if a product is no longer functional, see Inspection.

3.4

Preparation at the place of use

► If applicable, rinse surfaces that are not accessible for visible inspection (preferably with demineralized water),

for instance using a disposable syringe. ► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Put the wet product into a closed disposal container and have it transferred to cleaning and disinfecting within

1 h.

3.5

Cleaning/Disinfection

3.7

3.5.1

Product-specific safety information on the reprocessing method

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

Hazardous for patients! ► Only reprocess the product using machine cleaning.

3.7.1

Risk to patient due to cross contamination! ► Contaminated products already used in the ZNS – Do not clean together with clean products in the same cleaning container, – Do not use in other areas, insofar as they have not been cleaned with 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 which – are approved for use on aluminum, plastic materials, and high-grade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.

3.6

Mechanical cleaning/disinfection with manual pre-cleaning

Note It is essential that the cleaning and disinfection device used is officially recognized or certified as effective (e.g. fulfillment of EN ISO 15883). Note The washer-disinfector machine used for processing must be serviced and checked at regular intervals.

Inspection

Visual inspection

► Ensure that all contamination has been removed. In particular, pay attention to mating surfaces, shafts, recessed

areas and drill grooves. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. corroded, loose, bent, broken, cracked, worn or severely scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the product for damage to the spiral element. ► 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

► Check that the product functions correctly. Check consistency (for instance with an appropriate mandrin). ► Check for compatibility with associated products. ► 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.

3.6.1

Manual pre-cleaning with brush

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

3.9

I

Cleaning

RT (cold)

>15

1

DW

B. Braun Stabimed® fresh

► Validated sterilization process

RT (cold)

1

II

Rinsing

DW: RT:

opening any valves and faucets).

-

DW

Note The product is also suitable for sterilization at 134 °C, holding time 18 min.

Drinking water Room temperature

► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted

Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.

Mechanical alkaline cleaning and thermal disinfection

Machine type: single-chamber cleaning/disinfecting machine without ultrasound1) Phase

Step

D [°C/°F]

t [min]

Water quality

Chemistry

I

Pre-rinse

<25/77

3

DW

-

II

Cleaning

55/131

10

FD–W

Alkaline cleaner

3)

► 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.

III

Neutralization3)

>10/50

2

FD–W

B. Braun Helimatic® Neutralizer C Working solution 0.15 %

IV

Intermediate irrigation I

>10/50

1

FD–W

-

5.

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging.

V

Intermediate irrigation II3)

>10/50

1

FD–W

-

VI

Thermal disinfection

90/194

5

FD–W

-

VII

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

DW: FD–W: 2)

load according to the manufacturers’ specifications is not exceeded.

3.10 Storage

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.

Utility solution pH ~ 112)

1)

– 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

-

Phase I ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed. ► If applicable, brush non-visible surfaces for at least 1 minute with a suitable cleaning brush. ► Then flush these areas thoroughly at least five times with the cleaning disinfectant solution using a disposable syringe (20 ml).

3.6.2

Steam sterilization

► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g., by

Drinking water Fully desalinated water The following cleaning and disinfection devices were used to verify cleanability: Miele PG 8585 Dr. Weigert neodisher® SeptoClean was used to verify cleanability. Due to the high pH value of the cleaner, the neutralization and the second intermediate irrigation was used.

► Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots). ► Also fully clean and rinse the interiors of instruments with cavities. Use special inserts with irrigation devices

designed for the instruments for this purpose. ► Connect components with lumens and channels directly to the rinsing port of the injector carriage. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

Disposal

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 reprocessing procedure. TA015927

2021-02

Change No. 63662