Instruments for application in the central nervous system

General information

Intended use

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 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: ■ Optical changes in 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 surface and could cause corrosion ► For further detailed information on hygienically safe and material-preserving/value-preserving reprocessing, see www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

The instruments for application in the central nervous system are used for holding and dissecting in surgical operations on the central nervous system (e.g. at the pituitary or the brain).

Preparations at the place of use

Aesculap® Instruments for application in the central nervous system Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product

Applicable to ► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

at https://extranet.bbraun.com

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

using a disposable syringe, for example.

Indications 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.

► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure

Contraindications

Danger to the patient! ► Only mechanically reprocess the product.

None known.

Risks and side effects

DANGER

As part of the legal duty to inform, the following typical risks and side effects associated with the use of surgical instruments are referred to. These are predominantly procedure-specific, non product-specific and not limited to unwanted damage to surrounding tissue resulting in e.g. bleeding, infection, material incompatibilities or instrument parts remaining unnoticed in the patient, etc.

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

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! ► 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).

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – be approved for plastic material 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 temperature of 60 °C.

► With PVD coated products, do not use oxidizing process chemicals (e.g. H2O2), as these can cause bleaching or

layer loss. ► 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. ► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids.

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

Mechanical cleaning/disinfecting 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).

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING

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

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

Validated reprocessing procedure

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemistry/Note

General safety notes

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

Dr. Weigert neodisher® SeptoClean 1 %* working solution

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.

III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD–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.

V

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

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

Note For up-to-date information about 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.

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean) ► Mount jaws protection on the product. ► Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots). ► Connect components with lumens and channels directly to the rinsing port of the injector carriage. ► Keep working ends open for cleaning. ► Place instruments in the tray with their hinges open. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.