KAIRison pneumatic bone punch

en ®

Aesculap KAIRison® pneumatic bone punch

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.

2.3.3

Sterility

Single-use products

Legend 1 KAIRison® pneumatic bone punch 2 Punch slider part 3 Punch lower part 4 Sprung ball bearing 5 Bone ejector pin 6 Punch shaft complete 7 Shaft release/locking slider 8 Handle 9 Compressed-air connector (air inlet) 10 Compressed-air connector (air exhaust) 11 Safety button (to lock the trigger) 12 Trigger 13 Locking lever (for locking the slider part) 14 Hook 15 Actuator lever 16 Single-use tube set 17 Pressure reducer 18 Aesculap compressed-air tube 19 Compressed-air wall connector

1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply for the KAIRison® pneumatic bone punch. Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun

eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

Art. no.

Description

FK888SU

Single-use tube set

► Do not reuse the product.

The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess the product. 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.

2.4

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

2.4.1

Components required for operation

Art. no.

Description

FK899R

Connect the handpiece

See brochure, Aesculap pneumatic bone punch

Shafts

FK898R

Pressure reducer

FK888SU

Single-use tube set

See brochure, Aesculap pneumatic bone punch

Aesculap compressed-air tube*

2.

Clinical use

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

2.1

Available sizes

2.4.2

For detailed information on available sizes/ variants, see the KAIRison® pneumatic bone punch brochure.

2.2

Areas of use and limitations of use

2.2.1

Intended use

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

2.4.3

2.2.2

2.4.4

Indications

Operating principle

The KAIRison® pneumatic bone punch is powered by compressed air taken in through the compressed-air connector (supply air) 9 and let out through the compressed-air connector (exhaust air) 10. This is then transferred into the working direction via an actuator lever 15. The slider part 2 is moved forward, resulting in the punching action (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 The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.

Note Use the KAIRison® pneumatic bone punch with authentic Aesculap products only, see Accessories / spare parts. Observe the nominal operating pressure of at least 8 bar to ensure full cutting performance.

For indications, see Intended use.

Note To insert the shaft, compressed air must be connected and the actuator lever must be in the neutral shaft-insertion position.

2.2.3

Contraindications

No known contraindications.

2.3

Safety information

2.3.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

2.3.2

Product

Product-specific safety information 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 there is a nominal operating pressure of at least 8 bar.

► 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 (air inlet) 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.

2.4.5

Safety devices

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.

2.4.6

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.

2.4.7

Triggering the punch action

Punching can be performed either in 2 steps or immediately, by skipping the positioning step: ■ 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 trigger 12, see Fig. 7 (short arrow). ► For punching/cutting, firmly press actuating trigger 12, see Fig. 7 (long arrow).

2.4.8

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

3.8

Cleaning/Disinfection

3.8.1

Product-specific safety information on the reprocessing method

Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for plastics (handle) and surgical steel (shafts and pressure reducer), – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. Risk of corrosion/functional failure due to incorrect processing! ► Allow any fluid that has penetrated the device to run out immediately. Damage to the product/functional failure caused by fluids entering compressed-air 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 disposed of in a wet condition. To prevent foaming and

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water

3.8.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ Drying phase: Use a lint-free

Chapter Manual cleaning/disinfection and subsection:

Fig. 10. This completes detaching shaft 6 from the handle.

3.

Validated reprocessing procedure

3.1

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.

cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection

■ Shafts ■ Pressure reducer

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 "AKI-Brochures", "Red brochure".

3.3

Single-use products

Art. no.

Description

FK888SU

Single-use tube set

► Do not reuse the product.

The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess the product.

3.4

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.5

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.

3.6

Preparing for cleaning

► Disassemble system components (tubes, shafts and pressure reducer) immediately after use. ► 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. ► Disassemble the product prior to cleaning, see Disassembly.

3.7

Disassembly

► 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.

This completes disassembling of shaft 6.

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

is suitable for cleaning (avoid rinsing blind spots). Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ Handpiece

■ Attach sealing caps to connections for compressed air.

■ Suitable cleaning brush ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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

Note If there is no final sterilization, then a virucidal disinfectant must be used.

3.2

sealing caps to connections for compressed air.

immersion disinfection

■ Place the product on a tray that

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.

Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

■ With pressure reducer: Attach

■ Chapter Manual cleaning with

■ Place the product in the correct position in a suitable wire basket.

3.9

Manual cleaning/disinfection

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

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

3.9.1

Manual cleaning with immersion disinfection

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)

5

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature *Recommended: BBraun Stabimed fresh ► 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. 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. 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. 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 procedure.

3.10 Mechanical cleaning/disinfection

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

3.10.1 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfecting machine without ultrasound Step

D [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.12.1 Visual inspection

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).

Phase

3.12 Inspection

Water quality

Chemical/Note

3

D–W

-

10

FD-W

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

■ working solution 0.5% – 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

DW: FD–W:

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

3.11 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).

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical service.

3.12.2 Functional test CAUTION Damage (metal cold welding/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: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working properly (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.13 Assembly 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

Fig. 13. ► Push forward slider 2 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.

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

3.14 Packaging

3.11.1 Manual pre-cleaning with a brush 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

Rinsing

RT (cold)

1

-

D–W

-

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

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 sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.15 Steam sterilization Note The shafts can be sterilized either in disassembled condition or in assembled condition.

► 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.

► Make certain that all external and internal surfaces of the product will be exposed to the sterilizing agent. ► 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 fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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

trolled room.

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.

3.16.1 Ambient conditions

3.11.2 Mechanical alkaline cleaning and thermal disinfecting

Temperature

-10 °C to 50 °C

Relative humidity

10 % to 90 %

Atmospheric pressure

500 hPa to 1 060 hPa

The following environmental conditions apply to the transport and storage of the product:

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

■ working solution 0.5% – 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: FD–W:

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

4.

Maintenance and service

4.1

Maintenance

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

4.2

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

4.3

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

Slider part does not return to its rest position

Compressed-air failure/system defect

Dismount/remove shaft slider part from handle

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. 8 bar operating pressure)

Punching is not carried out

Repair by manufacturer Shaft cannot be installed in the handle

4.4

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 Assembly

Incorrect position of the actuator

Actuator not in insertion position

Connect compressed air at the handle

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

Handle

See brochure, Aesculap pneumatic bone punch

Shafts

See brochure, Aesculap pneumatic bone punch

Aesculap compressed-air tube

4.5

Technical Data

Nominal operating pressure

8 bar

Weight (complete system)

450 g

Dimensions incl. shaft

330 mm x 150 mm x 35 mm

5.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. WARNING Risk of injury due to sharp-edged and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents injury by the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA011795

2020-07

V6

Change No. 62345