KAIRISON Pneumatic Bone Punch Instructions for Use/Technical Description

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

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).

Validated procedure

Specific requirements

Reference

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

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ Disposable syringe, 20 ml ■ Drying phase: Use a lint-free cloth

Chapter Manual cleaning/disinfection and sub-chapter:

or medical compressed air Mechanical alkaline cleaning and thermal disinfection

■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ Shafts only

■ Place products in the tray with their hinges open. Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place the product in a tray that is

■ Handpiece only

suitable for cleaning (avoiding rinsing blind spots).

■ Position the product in such a way that fluids can flow out.

■ Place the product in the correct

■ Chapter Manual cleaning with immersion disinfection

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:

I

Prerinse

<25/77

3

D–W

-

■ Chapter Mechanical alkaline

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

cleaning and thermal disinfecting

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution

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

■ Chapter Manual pre-cleaning

– 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

with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

position in a suitable wire basket. Manual pre-cleaning with brush and subsequent mechanical neutral or mild alkaline cleaning and thermal disinfection

■ Pressure reducer only

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ Position the product in such a way that fluids can flow out.

■ Place the product in the correct

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

■ Chapter Manual pre-cleaning

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

with a brush

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

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).

position in a suitable wire basket.

Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

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

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning /disinfection process if necessary.

Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Manual cleaning with immersion disinfection 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*

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

II

Intermediate rinse

RT (cold)

1

-

D–W

-

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

III

Disinfection

RT (cold)

15

2

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-

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W:

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

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

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. ► Drain any remaining water fully.

■ 0.5 % working solution – pH = 11*

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

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

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.

V

Drying

-

-

-

According to the program for cleaning and disinfection device

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

D–W: FD–W:

Drinking water 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.

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Storage

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

► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area. ► Store sterile packed single-use products dust-protected in a dry, dark and temperature-controlled room.

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

Neutral:

Maintenance To ensure reliable operation, the product must be maintained at least once a year. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

■ Concentrate: – pH neutral – <5 % anionic surfactant

■ 0.5 %* working solution

Troubleshooting list Malfunction

Detection

Cause

Remedy

Slider part not moving

Product does not work

No compressed air

Check/connect compressed-air supply

Product does not work

Insufficient compressed air

Check/connect compressed-air supply

No material removed on the bone

Blunt cutting edge

Repair by manufacturer

Mildly alkaline:

■ Concentrate: – pH = 9.5 – <5 % anionic surfactant

■ 0.5 % solution Punching is not carried out

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

Slider part does not return to its rest position

Compressed-air failure/ system defect

Dismount/remove shaft slider part from handle

V

Drying

-

-

-

According to the program for cleaning and disinfection device

Compressed-air leak (hissing)

Defective seals in handle

Repair by manufacturer

Product does not work

Shaft guides installed incorrectly

Install shaft guides correctly

Product does not work (air pressure drop)

Insufficient pressure

Check compressed-air supply (min. 7 bar operating pressure)

Incorrect slider part position

Components not centered correctly Correct positioning of the slider part and main part of the shaft.

Check positioning Sprung ball bearing must be engaged, see Assembling

Incorrect position of the actuator

Actuator not in insertion position

Connect compressed air at the handle

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner neutral

Repair by manufacturer

► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

Shaft cannot be installed in the handle

Inspection, maintenance and checks

CAUTION

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).

Technical Service ► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the product 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. ► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products.

Packaging

WARNING

The sterility of the KAIRISON pneumatic bone punch can not be assured if the connectors at the handle and pressure reducer are sealed! ► Prior to packaging, remove the sealing caps from the connectors at the handle and at the pressure reducer.

► Appropriately protect products with fine working tips. ► 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 Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

Steam sterilization Note The shafts can be sterilized either in disassembled condition or in assembled condition. ► 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 fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractional vacuum process at 134 °C/holding time 5 min ► When sterilizing several products 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.

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. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method Prevacuum

Temp. 270 °F/275 °F

Time 4 min

Minimum drying time 20 min

*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.

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

Accessories/Spare parts Art. no.

Designation

FK881R

Storage for handle and pressure reducer

FK888SU

Single-use tube set

FK891R

Storage for shafts

FK898R

Pressure reducer

FK898214

Sealing cap for compressed-air connector (pressure reducer)

FK898215

Sealing cap

FK899R

Connect the handpiece

RT035

Compressed-air bifurcation

see brochure, KAIRISON pneumatic bone punch

Shafts

see brochure, KAIRISON pneumatic bone punch

Aesculap compressed-air tube

Technical Data Nominal operating pressure

8 bar

Weight (complete system)

450 g

Dimensions incl. shaft

330 mm x 150 mm x 35 mm

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

Distributor in the US/Contact in Canada for product information and complaints 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 011795

11/12

V6

Änd.-Nr. 45542