Ventricular cannulas

en ®

Aesculap Ventricular cannulas

7.5

Cleaning/disinfection

7.5.1

Product-specific safety notes on the reprocessing procedure Danger to the patient! ► Reprocess the product only with manual pre-cleaning followed by mechanical cleaning.

Symbols on product and packages

DANGER

Caution, general warning symbol Caution, see documentation supplied with the product

Risk to patient due to cross contamination! ► Do not clean contaminated products together with uncontaminated products in a tray. DANGER

1.

Intended use

The puncture cannula are used for puncturing intracerebral fluid accumulations, such as the ventricular system, brain cysts or intracerebral hematomas.

2.

Indications

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents approved for, e.g., aluminum, plastics and high-grade steel, according to the manufacturer’s instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable temperature of 60 °C.

CAUTION

Indications, see Intended use. Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.

3.

► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-

tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.

Contraindications

None known.

4.

Risks and side effects

As part of the statutory disclosure duty, the following possible risks and side effects known to the manufacturer and connected with the use of surgical instruments are highlighted. These are primarily process-specific, not productspecific and comprise undesirable damage to the surrounding tissue, which can result in bleeding, infections, material incompatibility or instrument parts remaining unnoticed in patients, for example.

7.6

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 cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.

7.6.1

Manual pre-cleaning with brush

Note Detailed information about the available sizes/variants is given in the Aesculap brochures.

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

6.

I

Cleaning

RT (cold)

>15

1

D–W

B. Braun Stabimed® fresh

II

Rinsing

RT (cold)

1

-

D–W

-

5.

Available sizes

Safe handling and preparation

► Ensure that the product and its accessories are operated and used only by persons with the requisite training,

knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial

sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts.

7.

Validated reprocessing procedure

7.1

General safety notes

D–W: RT:

Drinking water Room temperature

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. ► Mobilize non-rigid components, such as set screws and hinges, during cleaning. ► Then flush these areas thoroughly at least five times with the cleaning disinfectant solution using a disposable syringe (20 ml).

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing.

Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws and hinges, during rinsing.

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.

7.6.2

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/reprocessing technician is responsible for this. The specified chemistry was used for validation.

7.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore, no more than 1 hour 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. 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 damage to metallic products. 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 processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ 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".

7.3

Reusable products

Influences from processing that result in damage to the product are unknown. The product can be used up to 75 times with the proper care and if it is undamaged and clean. Any additional reuse falls under the responsibility of the user. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional.

7.4

Preparations at the place of use

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

using a disposable syringe, for example. ► 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 hr.

Mechanical alkaline cleaning and thermal disinfection

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

Step

D [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

Dr. Weigert neodisher® SeptoClean working solution 1 %2)

III

Neutralization

> 10/50

2

FD–W

B. Braun Helimatic® Neutralizer C Working solution 0.15 %

IV

Intermediate irrigation I

> 10/50

1

FD–W

-

V

Intermediate irrigation II

> 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

D–W: Drinking water FD–W: Fully desalinated water 1) The following cleaning and disinfection device was used to verify cleanability: Miele 7836 CD 2) Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean) ► Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots) ► Place the product on the tray with all product links and joints open. ► Connect components with lumens and channels directly to the rinsing port of the injector carriage. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

7.7

Inspection, maintenance and checks

► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and

free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical Service.

7.8

Packaging

► Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

7.9

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 fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractional vacuum process at 134 °C, holding time 18 minutes for prion inactivation ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

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

8.

Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING

► For service and repairs, please contact your national B. Braun/Aesculap agency.

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

9.

Disposal

► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!

TA012933

2020-06

V6

Change No. 60792