Flexible 1.mm spiral shaft instrument for neuroedoscopy Instructions for Use

en ®

Aesculap Flexible 1-mm spiral shaft instruments for neuroendoscopy Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product

1.

Intended use

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 ► For detailed information on hygienically safe and material-friendly/careful processing, please refer to www.a-k-i.org Header "AKI-Brochures", "Red brochure".

7.3

The flexible 1-mm spiral shaft instruments for neuroendoscopy, which are inserted through the working channel of an endoscope, serve to cut, grasp and remove biopsies.

7.4

2.

7.5

Indications

Reusable products

There are no known effects of processing resulting in damage to the product. The product can be re-used up to 75 times with proper care and if it is undamaged and clean. Any additional reuse falls under the responsibility of the user. Careful visual and functional testing prior to the next use is the best way to identify a malfunctioning product.

Disassembling the product before carrying out the reprocessing procedure

► Open up products with hinges.

Preparations at the place of use

Indications, see Intended use.

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

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

► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Place the wet product in a sealed waste container and take it to be cleaned and disinfected within 1h.

3.

Contraindications

3.1

Absolute contraindications

using a disposable syringe, for example.

7.6

Cleaning/disinfection

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

None known.

3.2

Relative contraindications

Based on our current knowledge, there are no product-specific relative contraindications. However, there are medical or surgical conditions that may interfere with endoscopic techniques, such as strong bleeding or high protein levels within the ventricular system limiting the view in the surgical field. In case of relative contraindications, the user shall decide on the use of the product on an individual basis.

4.

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

Risks and side effects

DANGER

As part of the legal obligation to provide information, the possible risks and side effects in connection with the use of surgical instruments known to the manufacturer are highlighted below. These are predominantly process-specific, not product-specific, and include unwanted damage to surrounding tissue, such as bleeding, infection, incompatibility of materials, or parts of instruments left unnoticed in the patient.

5.

Safe handling and preparation

CAUTION

► 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. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).

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 permitted cleaning temperature of 55 °C. Damage to the flexible shaft caused by application of a cleaning brush! ► Preclean the flexible shaft only with a soft, lint-free wipe.

CAUTION ► Do not use oxidizing chemicals (e.g. H2O2), which could cause bleaching/layer loss of the product. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-

6.

Safe operation Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING

WARNING

Risk of damage to the jaw parts or working channel if the jaw parts are opened while they are in the working channel of the endoscope! ► When inserting the instrument into, or removing it from, the working channel, make certain that the jaw piece is closed.

► When inserting the instrument into the working channel, do not apply undue force to the instrument, as this

could damage the jaw parts, spiral shaft or working channel of the endoscope. Note The bending radius of the spiral shaft during storage and use must be at least 150 mm.

7.

Validated reprocessing procedure

7.1

General safety notes

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

– as an effective mechanical supplement to manual cleaning/disinfecting. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfecting. – as an integrated mechanical support measure for mechanical cleaning/disinfecting. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting. ► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids.

7.7

Mechanical cleaning/disinfection with manual pre-cleaning

Note As a matter of principle, the efficacy of the cleaning and disinfection device must be certified (e.g. in accordance with EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.

Manual pre-cleaning with ultrasound Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Ultrasonic cleaning

RT (cold)

>15

1

D–W

B. Braun Stabimed® fresh

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.

II

Rinsing

RT (cold)

1

-

D–W

-

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.

D–W: RT:

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

7.2

General information

Dried and hardened or clotted surgical residues can complicate cleaning or render it ineffective and cause corrosion. Therefore, do not exceed a period of 1h between use and processing, make sure pre-cleaning temperatures are <45°C to prevent clotting, and do not use disinfectants that can cause clotting (active ingredient: aldehyde, alcohol). 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.

Drinking water Room temperature

Phase I ► Clean the product in an ultrasound cleaning bath (frequency of 35 kHz) for at least 15 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a soft, lint-free cloth in the solution until all visible residues have been removed from the surface. ► If applicable, brush non-visible surfaces for at least 1 minute with a suitable cleaning brush (e.g. TE654202). ► 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). 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.

Mechanical alkaline cleaning and thermal disinfection Type of device: Single-chamber cleaning/disinfection device without ultrasound1) Phase

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

DI–W

Dr. Weigert neodisher® SeptoClean 1% Working solution2)

III

Neutralization

>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 II

>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 machine

D–W: Drinking water DI–W: Deionized water 1) The cleaning and disinfection devices listed below were used to verify cleanability: Miele 7836 CD 2) Prion-deactivating detergent (see Specifications Dr. Weigert neodisher® SeptoClean) ► Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots) ► Place instruments in the tray with their hinges 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.

7.8

Inspection, maintenance and checks

CAUTION

Damage (metal seizure/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: Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

► 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 product for proper function:

– Open and close instrument. – open laterally to approx. 45°, taking into account the bending radius of at least 150 mm. Shaft must move back to the home position. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service.

7.9

Packaging

► Appropriately protect products with fine working tips. ► 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.

7.10 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.

7.11 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!

TA013394

2020-08

V6

Change No. 60791