Kirschner wire chuck GB374R

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

Manual cleaning and wipe disinfecting

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.

5.2

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 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.

5.3

Dismantling prior to carrying out the reprocessing procedure

► Remove the Kirschner wire and drive from the Kirschner wire chuck.

5.4

Preparations at the place of use

► 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.

5.5

Preparation before cleaning

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:

Phase I ► Clean the product under running faucet water, using a suitable cleaning 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.

5.8

► Prior to first mechanical cleaning/disinfection process: Assemble Eccos holder GB673R in a suitable tray (e.g.

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

Mechanical cleaning/disinfecting

JF214R). ► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

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).

5.6

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

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

CAUTION

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfectant agents in line with the manufacturer's instructions that are approved for stainless steel. ► Observe specifications regarding concentration, temperature and exposure time. ► Avoid encrustation of residues/proteins (e.g. caused by aldehyde/alcohol). ► Only use bactericidal, fungicidal, and virucidal disinfectants. ► Preferably use thermal disinfecting processes. ► Do not exceed the maximum allowable temperature of 60 °C.

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

Neutral:

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

■ 0.5 %* working solution

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

Mildly alkaline:

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.

■ Concentrate:

► Do not clean motors/handpieces by ultrasonic treatment and do not immerse them in any liquids. To avoid the

■ 0.5 % solution

– pH = 9.5 – <5 % anionic surfactant

risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. III

Intermediate rinse

>10/50

1

FD-W

-

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

IV

90/194

5

FD-W

-

■ When cleaning products with movable

Thermal disinfecting

Manual cleaning and wipe disinfection

Chapter Manual cleaning/disinfecting and subsection:

V

Drying

-

-

-

According to the program for cleaning and disinfection device

hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

■ 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 neutral or mild alkaline cleaning and thermal disinfecting

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

■ Follow the instructions for use of the Eccos

D–W: FD–W:

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

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical neutral or

holder.

mild alkaline cleaning and thermal disinfecting

5.9

Inspection, maintenance and checks

► Allow the product to cool down to room temperature. ► Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged. ► mini-Line Spray through the motor/handpiece with Aesculap-STERILIT oil spray GB600 with adapter GB600830

for approx. 1 second.

5.7

Manual cleaning/disinfecting

► 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.

► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Set aside the product if it is damaged. ► Prior to an extended period of non-use, always store attachments cleaned and dried according to the instruc-

tions.

5.10 Packaging ► Always follow the instructions for use of the respective packaging and storage devices (e.g. instructions for use

TA009721 for the 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.

5.11 Steam sterilization

11.

► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure.

opening any valves and faucets). ► Validated sterilization process

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

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

6.

Maintenance

In order to ensure reliable operation, the product must be maintained after 300 reprocessing cycles or at least once a year. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

7.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Kirschner wire cannot be inserted into the Kirschner wire chuck

Kirschner wire will not go into the Kirschner wire chuck when the clamping lever is pressed down

Kirschner wire diameter is too large

Choose a Kirschner wire with a diameter of 0.6 mm to 1.6 mm

Kirschner wire with appropriate diameter (0.6 mm to 1.6 mm) cannot be inserted into the Kirschner wire chuck

Cannula is dirty

Clean cannula with special cleaning brush

Clamping lever is not pressed down or not pressed down enough

Fully press the clamping lever as far as it will go

Clamping lever jammed

Have the product repaired by the Technical Service

Cannula is dirty

Clean cannula with special cleaning brush

Clamping mechanism is defective

Have the product repaired by the Technical Service

Drive unit defective

Have the product repaired by the Technical Service

Kirschner wire slips through

Kirschner wire not turning

8.

Kirschner wire cannot be inserted into the bone

Kirschner wire cannot be inserted into the bone

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

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

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.

9.

Accessories/Spare parts

Art. no.

Designation

GB600

STERILIT oil spray with adapter GB600830

e.g., LX132S

Kirschner wires

GB673R

Eccos holder

FM732800

Cleaning brush

10.

Technical data

Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

GB374R

Kirschner wire chuck

IIa

Diameter of Kirschner wire

0.6 mm to 1.6 mm

Max. allowable Kirschner wire length

160 mm

Dimensions of Kirschner wire chuck (L x W x H)

80 mm x 50 mm x 20 mm

Weight of Kirschner wire chuck

approx. 120 g

Disposal

► Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap

agency, see Technical Service. TA-Nr. 011686

01/14

V6

Änd.-Nr. 48673