Microsurgical scissors for coils

Disassembling the product before carrying out the reprocessing procedure ► Open up products with hinges.

Aesculap® Microsurgical scissors for coils

Preparations at the place of use

Symbols on product and packages

► 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.

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

using a disposable syringe, for example.

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

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

Intended use Microsurgical scissors for coils are used to dissect and prepare tissue and blood vessels and to cut through coil wires in microsurgical interventions.

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

Indications Indications, see Intended use. DANGER

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

Contraindications CAUTION

None known.

Risks and side effects

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 – are approved for (e.g. aluminum, plastics, 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.

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.

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

Safe handling and preparation

► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the

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

CAUTION Federal law restricts this device to sale by, or on order of a physician!

Mechanical cleaning/disinfection with manual pre-cleaning

WARNING

Damage to, or destruction of the microsurgical scissors caused by application outside their intended use! ► For cutting through platinum coil wires, only use scissor types specially designed for this purpose.

► 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).

Validated reprocessing procedure General safety notes 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/reprocessing technician is responsible for this. The specified chemistry was used for validation. 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.

Note The cleaning and disinfecting machine must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.

Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Disinfectant cleaning

RT (cold)

>15

1

D–W

Dr. Weigert neodisher® SeptoClean*

II

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean) Phase I ► Fully immerse the product in the cleaning/disinfecting solution for at least 15 minutes. Ensure that all accessible surfaces are moistened. ► 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). 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 Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

Dr. Weigert neodisher® SeptoClean 1 %* working solution

III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD–W

-

V

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

General information 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.

t [min]

Water quality

Chemicals

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) ► Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots) ► Keep working ends open for cleaning. ► Place instruments in the tray with their hinges open. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.