Diamond knife

General information ®

Aesculap Diamond knife Legend 1 2 3 4 5 6

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

Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product

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 measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. 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 in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. 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 of 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 surfaces 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 Publications, Red Brochure – Proper maintenance of instruments.

Preparations at the place of use ► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

Date of manufacture

Preparation before cleaning ► Remove any visible surgical residues as much as possible with a damp, lint-free cloth, wiping over the blade towards the tip. ► Retract the diamond blade into the sleeve and lock it in this position.

Cleaning/disinfection

Applicable to

Product-specific safety notes on the reprocessing procedure

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

www.extranet.bbraun.com

Intended use Diamond knives are suitable for microsurgical operations. The blades are extremely sharp for making precise microincisions or performing fine preparations.

WARNING

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

CAUTION

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

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

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

► 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.

CAUTION

► Replace any damaged components immediately with original spare parts.

Safe operation

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

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

tiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. Injury to the patient caused by chipping of the diamond blade! ► Avoid contact of the delicate blades at tips with hard surfaces or other instruments. ► Use the instrument only in accordance with its intended use.

WARNING

Damage to the diamond blade! ► Avoid contact of the delicate blades at tips with hard surfaces or other instruments. ► Keep the diamond blade protected by the sleeve when the instrument is not in use.

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

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ 20 ml disposable syringe ■ Phase 1 Extend the diamond blade

Chapter Manual cleaning/disinfection and sub-chapter:

from the sleeve and lock it in this position. Clean the diamond blade with a single-use cleaning wipe, wiping over the blade towards the tip. Do not clean the diamond blade with cleaning brushes.

CAUTION

Extending the diamond blade from the sleeve

■ Chapter Manual cleaning with immersion disinfection

■ Phase 5 Dry the product with a lint-

► Unlock activation sleeve 6 by turning it in the direction of the arrow, see Fig. 1.

free cloth, wiping over the blade towards the tip, or with medical compressed air.

► Push activation sleeve 6 towards the instrument tip, see Fig. 2. ► Lock activation sleeve 6 by turning it in the direction of the arrow, see Fig. 3.

■ Retract the diamond blade into the

Diamond blade 3 is now extended and fixed.

sleeve and lock it in this position.

Retracting the diamond blade into the sleeve ► Unlock activation sleeve 6 by rotating it. ► Push activation sleeve 6 towards the instrument end. ► Lock activation sleeve 6 by rotating it.

Diamond blade 3 is now retracted and fixed.

Validated reprocessing procedure General safety instructions

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ 20 ml disposable syringe ■ Extend the diamond blade from the sleeve and lock it in this position. Clean the diamond blade with a single-use cleaning wipe, wiping over the blade towards the tip. Do not clean the diamond blade with cleaning brushes.

■ Retract the diamond blade into the sleeve and lock it in this position.

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

■ Place the instrument in a tray that is

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.

■ Connect components with lumens and

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on 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.

suitable for cleaning (avoiding rinsing blind spots). channels directly to the rinsing port of the injector carriage.

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Manual cleaning/disinfection

Inspection, maintenance and checks

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues.

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).

► Repeat the cleaning /disinfection process if necessary.

Manual cleaning with immersion disinfection

CAUTION

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the instrument 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 Technical Service.

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 sterile Aesculap containers).

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and disinfection procedure.

Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. 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 from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.

► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

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 fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several instruments 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.

► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.

Sterilization for the US market ■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. ■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.

Phase II

To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters:

► Mobilize non-rigid components, such as set screws, links, etc. during cleaning.

► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters*

► Drain any remaining water fully.

Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible

surfaces are moistened. *Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc. 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 crosscontamination.

Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection proce-

dure.

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

Mechanical cleaning/disinfection with manual pre-cleaning 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).

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

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

Manual pre-cleaning with a brush

WARNING

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfectant cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

Rinsing

RT (cold)

II

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and disinfection procedure.

Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. 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 from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.

Phase II

► 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] Or in the US: 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.

► Rinse/flush the product thoroughly (all accessible surfaces) under running water.

Disposal

► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

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

Mechanical alkaline cleaning and thermal disinfecting

Distributor in the US/Contact in Canada for product information and complaints

Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

Water quality

Chemical

3773 Corporate Parkway Center Valley, PA, 18034, USA

3

D–W

-

TA-Nr. 012017

10

FD-W

■ Concentrate, alkaline:

t [min]

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

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Änd.-Nr. 47483