Diamond Knife Instructions for Use

Aesculap Neurosurgery

Diamond knife Legend

Safe handling and preparation

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CAUTION Federal law restricts this device to sale by or on order of a physician! ¾ Read, follow and keep the instructions for use. ¾ Use the product only in accordance with its intended use, see Intended use. ¾ Clean the new product either manually or mechanically prior to the initial sterilization. ¾ Store any new or unused products in a dry, clean and safe place. ¾ Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or fractured components. ¾ Do not use the product if it is damaged or defective. Set aside the product if it is damaged.

Diamond knife (diamond blade retracted) Diamond knife (diamond blade extended) Diamond blade Sleeve Handle Activation sleeve with rinsing connector

Symbols on product Attention, see instructions for use

Intended use Diamond knives are used for general neurosurgical operations. The precise incisions achievable with these instruments is among the preconditions for application in delicate surgical interventions at the: • Arachnoid • Dura • Nerves

Safe operation

WARNING

CAUTION

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Injury to the patient caused by chipping of the diamond blade! ¾ Avoid contact of the delicate blades at tips with hard surfaces or other instruments. ¾ Use the instrument only in accordance with its intended use. Damage to the diamond blade! ¾ Avoid contact of the delicate blades at tips with hard surfaces or other instruments. ¾ Keep the diamond blade protected by the sleeve when the instrument is not in use.

Extending the diamond blade from the sleeve ¾ Unlock activation sleeve 6 by turning it in the direction of the arrow, see Fig. 1.

¾ Lock activation sleeve 6 by turning it in the direction of the arrow, see Fig. 3.

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Fig. 3 Diamond blade 3 is now extended and fixed. Fig. 1 ¾ Push activation sleeve 6 towards the instrument tip, see Fig. 2.

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Retracting the diamond blade into the sleeve ¾ Unlock activation sleeve 6 by rotating it. ¾ Push activation sleeve 6 towards the instrument end. ¾ Lock activation sleeve 6 by rotating it. Diamond blade 3 is now retracted and fixed.

Fig. 2

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Aesculap Neurosurgery

Diamond knife Validated processing procedure Note Observe all relevant national regulations and standards with regard to processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of the products. Note Mechanical processing should be preferred over manual cleaning because of the better and more reliable cleaning results of mechanical processing. Note Successful processing of this medical product can only be ensured through a validated processing procedure. The user/processor is responsible for the validation. Due to process tolerances, manufacturer’s specifications can only serve as guide values for the processing procedures applied by the individual user. Note Up-to-date information on processing can be found on the Aesculap Extranet at www.aesculap-extra.net

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General notes Encrusted or fixated residues from surgery can make the cleaning process more difficult or ineffective, and can cause corrosion of “stainless” steels. Therefore the time interval between application and processing should not exceed 6 h, and neither fixating precleaning temperatures > 45 °C nor any fixating disinfecting agents (active ingredient: aldehyde, alcohol) should be used. Excessive doses of neutralizers or basic detergents can cause chemical degradation and/or fading of the laser engraving on stainless steel. Residues containing chlorine or chlorides, as contained e.g. in surgical residues, tinctures, medicines, saline solutions, servicewater used for cleaning and in cleaning/disinfecting agents, will cause corrosion damage (pitting, stress corrosion) and, consequently, destruction of stainless steel products. To remove such residues, the products must be rinsed sufficiently with fully desalinated water and dried thoroughly. Only use process chemicals recommended by the chemicals’ manufacturers as effective cleaning/ disinfecting agents compatible with the materials used in the respective product. Strictly observe all application instructions, e.g. regarding temperatures, concentrations, exposure times, etc. Failure to do so can result in the following problems • Optical changes to the material, 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 or • Material damage, e.g. corrosion, cracks, fracturing, premature aging or swelling.

¾ Clean the product immediately after use. ¾ Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments. Preparations prior to cleaning ¾ Have the product dry in a disposal container and ready for immediate cleaning and disinfecting within 30 min after use. Cleaning/Disinfecting

WARNING

CAUTION

Cut injuries due to touching of the diamond blade! ¾ Do not touch the diamond blade. ¾ Activate the sleeve when the instrument is not used. ¾ Apply proper caution when handling or cleaning the instrument.

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ¾ Use cleaning and disinfecting agents approved for titanium and high-grade steel according to manufacturer’s instructions. ¾ Observe specifications regarding concentration, temperature and exposure time. ¾ Do not exceed the maximum allowable cleaning temperature of 55 °C.

¾ If the microsurgical products can be securely fixed in machines or in storage devices in such a way that they will be thoroughly cleaned, clean and disinfect them mechanically.

Damage to the diamond blade! ¾ Avoid contact of the delicate blades at tips with hard surfaces or other instruments. ¾ Do not apply ultrasound treatment. ¾ Do not carry out immersion disinfection. ¾ Do not clean the diamond blade with cleaning brushes. ¾ Process and store the product in an appropriate storage unit. Ensure that the product is securely fixed in the storage unit.

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Aesculap Neurosurgery

Diamond knife Manual cleaning/disinfecting ¾ Extend the diamond blade from the sleeve and lock it in this position. ¾ Check visible surface for residues after manual cleaning/disinfecting. ¾ Repeat the cleaning process if necessary. Manual cleaning with disinfecting cleaning by wipe disinfection

Stage

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT (cold)

-

-

D–W

II

Wipe disinfection

-

1

-

-

III

Final rinse

RT (cold)

0.5

-

FD–W

-

IV

Drying

RT

-

-

-

-

D–W: FD–W: RT:

Meliseptol HBV wipes 30 % Propan-1-ol

Drinking water Fully desalinated water (demineralized) Room Temperature

Stage I

Stage II

¾ Clean the product under running tap water, using a suitable cleaning brush if necessary, until all visible residues have been removed from the surface. ¾ Do not clean the diamond blade with cleaning brushes. ¾ Mobilize non-rigid components, e.g. set screws, links, etc. during cleaning. ¾ To avoid the risk of corrosion, do not use a metal brush or other abrasives that would damage the surfaces for cleaning the product.

¾ Wipe all surfaces of the product with a single-use cleaning wipe. ¾ Clean the diamond blade with a single-use cleaning wipe, wiping over the blade towards the tip.

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Stage III ¾ After the prescribed exposure time (1 minute), rinse the disinfected surfaces under running FD water. ¾ Allow water to drip off for a sufficient length of time.

Stage IV ¾ Dry the product with a lint-free tissue. Mechanical cleaning/disinfecting ¾ Retract the diamond blade into the sleeve and lock it in this position. ¾ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots). ¾ Connect the rinsing connector of the diamond knife directly to the special connector at the injector trolley. Mechanical mild-alkaline cleaning and thermal disinfecting Machine type: Single-chamber cleaning/disinfecting machine without ultrasound Stage

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

< 25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

- concentrate, alkaline: pH = 9.5 < 5 % anionic tensides - 1 % solution: pH = 8.5

III

Intermediate rinse

70/158

1

FD–W

-

IV

Thermal disinfecting

94/201

10

FD–W

-

V

Drying

90/194

40

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized) ¾ Check visible surface for residues after mechanical cleaning/disinfecting. ¾ Repeat the cleaning process if necessary.

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Aesculap Neurosurgery

Diamond knife Control, care and inspection

Sterilization for the US market

¾ Allow the product to cool down to room temperature. ¾ Lightly lubricate moving parts (e.g. joints and links) with a maintenance oil suitable for the respective sterilization process (e.g. Aesculap STERILIT® spray JG600 or maintenance oil JG598). ¾ Inspect the product after each cleaning and disinfecting cycle to be sure it is clean, functioning properly, not damaged, has intact insulation and does not have any loose, bent, broken, cracked, worn, or fractured components. ¾ Set aside the product if it is damaged.

• Sterilization of the device may be accomplished by steam. • Aesculap does not recommend the device be sterilized by “Flash” or chemical sterilization. • Surgical instruments may also be placed within an Aesculap rigid sterilization container (sterile container) for processing under generally accepted hospital in-use conditions. The recommended sterilization parameters are as follows:

Packaging

Sterilization method

¾ Sort the product into its appropriate storage device or put it on a suitable tray. Make certain that all cutting edges are protected. ¾ Package baskets appropriately for the sterilization process (e.g. in Aesculap sterile containers). ¾ Pack the product in such a way that the packaging will prevent recontamination of the product in the period between reprocessing and reuse. Sterilization method and parameters ¾ Make certain that all external and internal surfaces will be exposed to the sterilizing agent (e.g. by opening all valves and faucets). ¾ Validated sterilization process – Steam sterilization through fractionated vacuum process – Steam sterilization acc. to EN 285/ANSI/AAMI/ ISO 11134-1993, ANSI/AAMI ST 46-1993, validated acc. to EN ISO 17665 or EN 554/ISO 13683 – Sterilization through fractionated vacuum process at 134 °C/holding time 5 min ¾ When sterilizing several products at the same time in one steam sterilizer: Make certain that the maximum allowable load capacity of the steam sterilizer, as specified by the manufacturer, is not exceeded.

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Minimum exposure time

Pre-vacuum

Temp.

270- 275 °F

Wrapped

In a sterile container system

4 min

4 min

WARNING for the US market If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross-contamination! Storage ¾ Store processed products in germ-proof packaging in a dust-protected, dry, dark and temperaturecontrolled room.

Technical Service For service, maintenance 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 95-2700 Fax: +49 7461 16-2887 E-mail: [email protected] Or in the US: Aesculap Inc. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood, MO 63042 Aesculap Repair Hotline Phone: +1 800 214-3392 Fax: +1 314 895-4420 Other service addresses can be obtained from the address indicated above.

Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA 18034 USA

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