Aesculap®

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Aesculap Neurosurgery

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Instructions for use/Technical description KAIRISON pneumatic bone punch Gebrauchsanweisung/Technische Beschreibung KAIRISON-pneumatische Knochenstanze Mode d’emploi/Description technique Pince emporte-pièce pneumatique KAIRISON Instrucciones de manejo/Descripción técnica Osteotomo neumático KAIRISON Istruzioni per l’uso/Descrizione tecnica Laminotomo pneumatico KAIRISON Instruções de utilização/Descrição técnica Puncionadora óssea pneumática KAIRISON Gebruiksaanwijzing/Technische beschrijving KAIRISON-pneumatische botstans Bruksanvisning/Teknisk beskrivning KAIRISON tryckluftsdriven benstans Инструкция по примению/Техническое описание Пневматические костные кусачки KAIRISON Návod k použití/Technický popis Pneumatický kostní štípák KAIRISON Instrukcja użytkowania/Opis techniczny Pneumatyczny odgryzacz kostny KAIRISON Návod na použivanie/Technický opis Pneumatické kostné kliešte KAIRISON Kullanım Kılavuzu/Teknik açiklama KAIRISON pnömatik kemik zımbası 사용 설명서 / 기술 설명 의료용핸드피스 (Kairison Bone punch FK899R/ 형명개별 기재 )

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Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com

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Aesculap – a B. Braun company TA-Nr. 011795

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V6

Änd.-Nr. 45542

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- DIR 93/42/EEC Technical alterations reserved

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Aesculap® KAIRISON pneumatic bone punch

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Legend

Single-use products

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

KAIRISON pneumatic bone punch Punch slider part Punch lower part Sprung ball bearing Bone ejector pin Punch shaft complete Shaft release/locking slider Handle Compressed-air connector (air inlet) Compressed-air connector (air exhaust) Safety button (to lock the trigger) Trigger Locking lever (for locking the slider part) Hook Actuator lever Single-use tube set Pressure reducer Aesculap compressed-air tube Compressed-air wall connector

Symbols on product and packages Sterilization using ethylene oxide

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). Only combine Aesculap products with each other. Operate the product only with compressed air or compressed nitrogen.

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product.

DANGER

Art. no.

Designation

FK888SU

Single-use tube set

The product is EO sterilized and sterile packed. The product must not be reused. ► 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. ► Do not use products from open or damaged sterile packaging. ► Do not re-sterilize the product. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date.

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

Not for reuse in intended applications as defined by the manufacturer

WARNING Use by

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

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 www.extranet.bbraun.com

Components required for operation Art. no.

Designation

FK899R

Connect the handpiece

see brochure, KAIRISON pneumatic bone punch

Shafts

FK898R

Pressure reducer

Intended use

FK888SU

Single-use tube set

The KAIRISON pneumatic bone punch is used for removing bone, cartilage and tissue in various surgical disciplines (e.g. neurosurgery, orthopedics and traumatology).

see brochure, KAIRISON pneumatic bone punch

Aesculap compressed-air tube*

Available sizes

* Regarding the operation and function of this product, follow instructions for use TA011106.

For detailed information on available sizes/ variants, see KAIRISON pneumatic bone punch brochure.

Operating principle

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

WARNING

CAUTION

Injury to the patient due to uncontrolled movement of the foot plate/sticking of the slider part in the bone! ► While punching, apply slight pull away force from the patient. ► After punching, keep the KAIRISON pneumatic bone punch closed and remove it from the bone before opening it. ► If the bone cannot be punched through, remove the closed KAIRISON pneumatic bone punch from the bone by slightly turning and pulling it away from the bone. ► Do not open the KAIRISON pneumatic bone punch while it is in contact with the bone. ► Note that only a limited volume of bone material can be punched (slider aperture larger than the bone volume to be taken). ► Do not use blunt shafts. ► To ensure proper operation of the KAIRISON pneumatic bone punch, make certain that the operating air pressure is at least 7 bar. Damage to, or destruction of the KAIRISON pneumatic bone punch caused by incorrect handling! ► Use the KAIRISON pneumatic bone punch only for its intended applications, see intended purpose. ► Avoid overstrain to the product due to turning or levering during the punching movement.

► 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.

The KAIRISON pneumatic bone punch is powered by compressed air taken in through the compressed-air connector (supply air) 9 and passed out through the compressed-air connector (exhaust air) 10. The compressed air power is transmitted into the working direction via the accuator lever 15. Moveable slider part 2 is moved forward and the punching action is carried out (in two steps).

Preparation Non-compliance with the following rules will result in complete exclusion of liability on the part of Aesculap.

Start-up Note Use the KAIRISON pneumatic bone punch with authentic Aesculap products only, see Accessories/Spare parts. Observe the operating pressure of at least 7 bar to ensure full cutting performance. Note To insert the shaft, compressed air must be connected and the actuator lever must be in the neutral shaft-insertion position. Note If there is only one compressed-air supply, compressed-air bifurcation adaptor RT035 can be used. In this way the user can avoid having to reconnect the system repeatedly (when a pneumatic motor is used as well). ► ► ► ► ► ► ► ►

Connect Aesculap pneumatic tube 18 to the pressure reducer 17, see Fig. 1. Connect Aesculap pneumatic tube 18 to compressed-air wall connector 19. Turn safety switch 11 to its OFF position, see Fig. 3. Connect single-use tube set 16 to handle 8 and pressure reducer 17. Connect compressed-air connector (exhaust air) 10. Connect compressed-air connector (supply air) 9. Insert the shaft, see Inserting the shaft in the handle. Turn safety switch 11 to its ON position, see Fig. 3. The KAIRISON pneumatic bone punch 1 is ready for operation.

Safety devices

Single-use products

Shaft release/locking slider

WARNING

Risk of injury due to inadvertent activation of the KAIRISON pneumatic bone punch! ► When cleaning the punch reservoir, the O.R. assistant carrying out this task must keep locking lever 13 pressed down until the cleaning procedure is completed.

► Press shaft release/locking slider 13 (for locking the slider part 2), see Fig. 2. ► Clean the punch aperture. ► Release shaft release/locking slider 13.

Slider part 2 can be moved again. Safety switch Note Hand over or put down KAIRISON pneumatic bone punch 1 in safe mode only! ► Turn safety switch 11 to its ON position, see Fig. 3.

Trigger 12 is in operating position. ► Turn safety switch 11 to its OFF position, see Fig. 3.

Trigger 12 is in safe position.

Inserting the shaft in the handle ► ► ► ►

Turn safety switch 11 to its OFF position, see Fig. 3. Prior to inserting shaft 6 in handle 8, verify that slider part 2 is in its correct position, see Fig. 14. Connect compressed air so that angle lever 15 moves to neutral insertion position, see Fig. 4. Engage hook 14 of shaft 6 in the handle location pin of handle 8 in the direction indicated by the arrow, see Fig. 5. ► Insert shaft 6 as far as it will go in the direction of the arrow and push-rotate it down until it engages, see Fig. 6. The KAIRISON pneumatic bone punch 1 is ready for operation. ► Make certain that shaft 6 is secured by locking button 7.

WARNING

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product!

Art. no.

Designation

FK888SU

Single-use tube set

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 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.ak-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

Triggering the punch action The tissue/bone can be punched either in two steps or, by skipping the positioning step, in a single punching action: ■ Positioning: Careful application of the cutting edge at the intended punching position, applying only mild force with minimal cutting effect. ■ Punching/Cutting: Forceful punching/cutting of the tissue. ► For the positioning step, gently press actuating lever 12, see Fig. 7 (short arrow). ► For punching/cutting, firmly press actuating lever 12, see Fig. 7 (long arrow).

Detaching the shaft from the handle ► ► ► ►

Turn safety switch 11 to its OFF position, see Fig. 3. Pull back locking button 7 in the direction of the arrow, see Fig. 8. Press down shaft 6 in the direction of the arrow, see Fig. 9. Disengage hook 14 of shaft 6 from handle adapter of handle 8 in the direction indicated by the arrow, see Fig. 10. This completes detaching shaft 6 from the handle.

Disassembling the product before carrying out the reprocessing procedure ► Disassemble system components (tubes, shafts and pressure reducer) immediately after use.

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.

Preparation before cleaning ► Check for debris on the sealing caps; clean if necessary. ► Seal compressed air connector (exhaust air) 10 and compressed-air connector (supply air) 9 at handpiece and

pressure reducer 17 with the sealing caps. ► Dismantle the product prior to cleaning, see Disassembling.

Cleaning/disinfection

Disassembling ► Push slider part 2 as far as it will go in the direction of the arrow, see Fig. 11. ► Remove slider part 2 from main part 3 in the direction of the arrow, see Fig. 12.

Product-specific safety notes on the reprocessing procedure

This completes disassembling of shaft 6.

Assembling

CAUTION

CAUTION Damage to the slider part caused by knocking the cutting edge! ► Verify that the guides are fitting properly. ► Note the pairing code (XXXX), see Fig. 13. ► Make certain the slider part is in its correct position (note the marking, see Fig. 14).

► Place the slider part 2 on the main part 3 in such a way that the ejector pin 5, bore and guides fit together, see

Risk of corrosion/functional failure due to incorrect processing! ► Do not apply ultrasonic cleaning to the handpiece and pressure reducer. ► Allow any fluid that has penetrated the device to run out immediately.

Fig. 13. ► Push forward slider2 in the direction indicated by the arrow until ball thrust piece 4 engages in its correct posi-

tion, see Fig. 14. Shaft 6 is assembled now and can be inserted in handle 8.

CAUTION

Validated reprocessing procedure General safety instructions Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile 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 products. 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.

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 plastics (handle), surgical steel (shafts) and aluminum (pressure reducer), – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 55 °C.

CAUTION

Damage to the product/functional failure caused by fluids entering compressedair connector (exhaust air)10/ compressed-air connector (supply air) 9 at the handle and pressure reducer! ► Apply sealing caps.

► 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. ► 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.

Validated cleaning and disinfection procedure

Mechanical cleaning/disinfecting

For mechanical 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).

Note Use appropriate (neutral, enzymatic and mild-alkaline) detergents on this product with its aluminum components. Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

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Chapter Manual cleaning/disinfection and sub-chapter:

Mechanical alkaline cleaning and thermal disinfection

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Shafts only

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

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Handpiece only

■ ■ Manual pre-cleaning with brush and subsequent mechanical neutral or mild alkaline cleaning and thermal disinfection

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Pressure reducer only

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Suitable cleaning brush Disposable syringe, 20 ml Drying phase: Use a lint-free cloth or medical compressed air Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

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Chapter Manual cleaning with immersion disinfection

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

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

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

Chapter Mechanical cleaning/disinfecting and sub-chapter:

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Prerinse

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

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Disinfecting cleaning

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

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Rinsing

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D–W

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Intermediate rinse

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D–W

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D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed

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Disinfection

RT (cold)

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D–W

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

► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

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Final rinse

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Drinking water 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 dis-

infection 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.

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

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

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse