Kirschner wire chucks GB417R, GB419R, GB427R, GB437R, GB439R

Aesculap® Kirschner wire chucks GB417R, GB419R, GB427R, GB437R, GB439R

Kirschner wire chucks GB417R, GB419R, GB427R, GB437R,Aesculap GB439R®

Legend

1 Protective sleeve 2 Screw cap 3 Drill 4 Drill anti-turn device (groove or catch) 5 Drive shaft 6 Clamping lever 7 Kirschner wire chuck anti-turn device (groove or catch) 8 Lever 9 Denticulation 10 Screw 11 Adjustment sleeve 12 Scale 13 Kirschner wire ∅ 0.7-2.5 mm

6.10 6.11 6.12 7. 8. 9. 10. 10.1 11. 12.

Packaging Steam sterilization Storage Maintenance Troubleshooting list Technical Service Accessories/Spare parts Kirschner wire attachment Technical data Disposal

1.

Applicable to

9 9 9 9 10 10 10 10 11 11

► For item-specific instructions for use and information on material

compatibility, see also www.extranet.bbraun.com

the

Aesculap

Extranet

at

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

2.

Safe handling

► Remove the transport packaging and clean the new product, either

manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order

Contents 1. 2. 3. 3.1 3.2 3.3 4. 5. 5.1 5.2 5.3 6. 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 2

Applicable to Safe handling Product description Components required for operation Intended use Operating principle Preparation Working with the Kirschner wire chuck System set-up Function checks Safe operation Validated reprocessing procedure General safety instructions General information Dismantling prior to carrying out the reprocessing procedure Preparations at the place of use Preparation before cleaning Cleaning/disinfection Manual cleaning/disinfecting Mechanical cleaning/disinfecting Inspection, maintenance and checks

2 2 3 3 3 3 3 3 3 4 4 5 5 5 5 6 6 6 7 8 9

not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. – Follow the application advisories acc. to standard, see Extracts from relevant standards. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user.

3.

Product description

5.

Working with the Kirschner wire chuck

3.1

Components required for operation

5.1

System set-up

Drill

Kirschner wire chuck Protective sleeve

GA437

GB417R, GB419R

GA437224

GA620, GA620S

GB437R, GB439R

GA437224

GB410

GB427R

GA437224

Note Use the appropriate Kirschner wires depending on the inidication.

3.2

WARNING

Intended use

The Kirschner wire chuck is used in orthopedic and traumatological procedures to place Kirschner wires in bone.

3.3

Note Products marked as unsterile must be sterilized, prior to use, according to respective instructions, see Steam sterilization.

WARNING

Operating principle

The Kirschner wire attachment is a quick-action chuck It is fitts on a suitable drill and tightens Kirschner wires with a diameter of 0.7 to 2.5 mm.

Risk of infection and contamination! The Kirschner wire chuck, its accessories and the motor drive are delivered unsterile. ► Sterilize the Kirschner wire chuck, its accessories and the handpieces before putting them into operation. The operator can be injured and the instrument components damaged if the motor is unintentionally run while the Kirschner wire chuck is being attached! ► Ensure that the motor is not unintentionally put into operation by the foot control, hand control, etc.

Connecting the accessories

4.

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Before using the Kirschner wire chuck and its accessories, check to be sure they are not damaged. ► Use the Kirschner wire chuck and its accessories only if they are in perfect condition.

Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. ► Please contact your B. Braun/Aesculap partner or Aesculap Technical Service (address: see Technical Service) with any inquiries in this respect. Connect the Kirschner wire chuck to the drill Coupling: ► Loosen lever the 8 by turning counterclockwise. ► Plug the Kirschner wire chuck into the drill 3. ► Ensure that the anti-turn devices 4 and 7 interlock. ► Tighten lever the 8 by turning clockwise. ► Check that the Kirschner wire chuck is firmly fixed.

Uncoupling: ► Loosen lever the 8 by turning counterclockwise. ► Withdraw the Kirschner wire chuck forwards from the drill 3.

3

Aesculap® Kirschner wire chucks GB417R, GB419R, GB427R, GB437R, GB439R

Change the position of the lever 8:

5.2

Function checks

► Couple the Kirschner wire chuck. ► Loosen the screw 10 with the key GB020 or Allen key TA004801 (span-

ner size 3 mm). ► Adjust lever 8 in the denticulation 9 to the new position. ► Tighten the screws. Set the Kirschner wire chuck GB417R, GB427R, GB437R and tighten Kirschner wire ► Press the clamping lever 6 upwards. ► Using the scale as a guide 12, set the adjustment sleeve 11 to the

diameter of the Kirschner wire 13. ► Insert the Kirschner wire 13 into the Kirschner wire chuck in such a

way that it is briefly clamped.

CAUTION

Danger of injuries and material damage due to incorrectly coupled Kirschner wire chuck and poorly tightened Kirscher wire! ► Ensure that the Kirschner wire chuck is correctly couple and that the Kirschner wire is correctly clamped.

► Ensure that the adjustment sleeve 11 can be adjusted over the entire

clamping range (of 0.7 to 2.5 mm). ► Ensure that the Kirschner wire 13 is securely carried when tightened,

and can be shifted when not tightened. ► Ensure that the Kirschner wire 13 is clamped so briefly and firmly that

is does not bend out of shape when setting.

► Press the clamping lever 6 downwards.

► Check to ensure that the clamping lever 6 rotates easily.

Set the Kirschner wire chuck GB419R, GB439R, and tighten Kirschner wire

5.3

Safe operation

► Press the clamping lever 6 forwards.

WARNING

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

WARNING

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

► Using the scale as a guide 12, set the adjustment sleeve 11 to the

diameter of the Kirschner wire 13. ► Insert the Kirschner wire 13 into the Kirschner wire chuck in such a

way that it is briefly clamped. ► Press the clamping lever 6 backwards.

Check that the Kirschner wire is firmly fixed ► Pull at Kirschner wire 13.

The Kirschner wire 13 must not shift. ► If the Kirschner wire 13 shifts: – Release the clamping lever 6. – Set a smaller Kirschner wire diameter: Rotate the adjustment sleeve 11 in such a way that a smaller diameter shows on the scale 12. – Close clamping lever 6. Mount the protective sleeve for long Kirschner wires

WARNING

Risk of damage to the user and bending of the Kirschner wire out of shape if the Kirschner wire juts a long way out of the drill at the rear! ► Use the sleeve (GA437224).

► Screw off the screw cap 2 with a hex driver (spanner size 3.5 mm; e.g.

LS001, LS003 or LS004). ► Screw on protective sleeve 1. ► Keep the screw cap 2 and screw it on again after dismantling the pro-

tective sleeve 1.

4

► Position the Kirschner wire and then insert it by gradually increasing

motor drive speed. ► If necessary, pull the Kirschner wire 13 further out of the Kirschner

wire churck: – Release the clamping lever 6 and readjust the length of the Kirschner wire 13. – Close clamping lever 6. – Check that the Kirschner wire 13 is firmly fixed.

6. 6.1

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.

6.2

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 precleaning 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.

6.3

Dismantling prior to carrying out the reprocessing procedure

► Take out the Kirschner wire and remove the Kirschner wire chuck from

the drill.

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Aesculap® Kirschner wire chucks GB417R, GB419R, GB427R, GB437R, GB439R

6.4

Preparations at the place of use

► Remove any visible surgical residues to the extent possible with a

tioning, allow any fluid that has entered the product to drain out immediately.

damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and

disinfection within 6 hours.

6.5

Preparation before cleaning

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

6.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

CAUTION

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 – be approved for plastic material and highgrade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time.

► Dry the product for at least 10 minutes at a maximum of 120 °C.

Note The indicated drying temperature is a guide temperature only. It must be checked taking into account the specific conditions (e.g. load) and adjusted if applicable. ► Do not clean motors/handpieces by ultrasonic treatment and do not

immerse them in any liquids. To avoid the risk of corrosion/malfuncValidated cleaning and disinfection procedure Validated procedure

Special features

Manual cleaning and wipe disinfection

■ When cleaning instruments with movable hinges, ensure that these

Reference

Chapter Manual cleaning/disinfecting and subare in an open position and, if applicable, move the joint while clean- section: ing. ■ Chapter Manual cleaning and wipe disinfecting ■ Drying phase: Use a lint-free cloth or compressed air for medical purposes

■ Ensure that the product is positioned in such a way that water will not enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered the product inadvertently.) Mechanical alkaline cleaning and thermal disinfecting

■ Insert the product in its proper position in the Eccos holder.

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

6

6.7

Manual cleaning/disinfecting

► 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. ► Repeat the cleaning/disinfection process if necessary.

Manual cleaning and wipe disinfecting Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT (cold)

-

-

D–W

-

II

Drying

RT

-

-

-

-

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

IV

Final rinse

RT (cold)

0.5

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W: RT:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature

Phase I ► Clean the product under running faucet water, using a suitable clean-

ing brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Phase II ► Dry the product in the drying phase with suitable equipment (e.g. cloth,

compressed air), see Validated cleaning and disinfection procedure. Phase III ► Wipe all surfaces of the product with a single-use disinfectant wipe.

Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected

surfaces under running FD water. ► 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.

7

Aesculap® Kirschner wire chucks GB417R, GB419R, GB427R, GB437R, GB439R

6.8

Mechanical cleaning/disinfecting

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 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

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – 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/disinfect-

ing.

8

6.9

Inspection, maintenance and checks

► Allow the product to cool down to room temperature.

6.12 Storage ► Store sterile products in germ-proof packaging, protected from dust, in

a dry, dark, temperature-controlled area.

► Inspect the product after each cleaning and disinfecting cycle to be

sure it is: clean, functional, and undamaged. ► Clamping lever 6 must rotate easily. ► Adjustment sleeve 11 must be easily pivotable. ► There must be sufficient holding force of the coupling between the Kirschner wire chuck and the drill. ► After every cleaning and disinfection, spray through with Aesculap STERILIT oil spray GB600. ► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Inspect tools for broken, damaged or blunt edges. ► Set aside the product if it is damaged.

7.

Maintenance

For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

6.10 Packaging ► Follow the instructions for use for the applied packaging and storage

systems (e.g. instructions for use TA009721 for Aesculap Eccos storage system). ► Insert the product in its proper position in the Eccos holder, or put it on a tray in such a way that the product is protected against damage. Ensure that all cutting edges are protected. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

6.11 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 – Disassemble the instrument – Steam sterilization through 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.

9

Aesculap® Kirschner wire chucks GB417R, GB419R, GB427R, GB437R, GB439R

8.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

The Kirschner wire 13 cannot be inserted

Kirschner wire chuck set to the incorrect Kirschner wire diameter

Adjustment sleeve 11 not set in accordance with the scale 12

Rotate the adjustment sleeve 11 in a clockwise direction until it is set at the correct diameter for the Kirschner wire

The clamping lever 6 is closed

Release the clamping lever 6

Kirschner wire chuck set to the incorrect Kirschner wire diameter

Adjustment sleeve 11 not set in accordance with the scale 12

Rotate the adjustment sleeve 11 in a counterclockwise direction until it is set at the correct diameter for the Kirschner wire

Open the clamping lever 6

Clamping lever 6 opened

Close the clamping lever 6

Kirschner wire chuck incorrectly coupled to the drill

Groove and catch of the anti-turn devices 4 and 7 do not interlock

Couple the Kirschner wire chuck correctly to the drill (see supply)

Drill

Drill 3 defective

See instructions for use for drill

The clamping lever 6 is closed

The clamping lever 6 is closed

Open the clamping lever 6

Kirschner wire attachment overtightening

Kirschner wire shows large grooves Release the clamping lever 6, rotate the adjustment sleeve11 in a clockwise direction and increase the diameter of the Kirschner wire

Kirschner wire 13 doesn’t rotate

The Kirschner wire 13 cannot be adjusted

9.

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

WARNING ► For service and repairs, please contact your national B. Braun/

Aesculapp 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 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

10

10. Accessories/Spare parts 10.1 Kirschner wire attachment Art. no.

Designation

GA437224

Protective sleeve

GB464R

Eccos mounting

11. Technical data Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

GB417R, GB419R, GB427R, GB437R, GB439R

Kirschner wire attachment

IIa

Kirschner wire diameter

0.7-2.5 mm

Weight

approx. 240 g

12. Disposal Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. ► Detailed information concerning the disposal of the product is avail-

able through your national B. Braun/Aesculap agency, see Technical Service.

11

- DIR 93/42/EEC

Technical alterations reserved

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

TA-Nr. 010325 Änd.-Nr. 48673

01/14

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