mini-Line K-wire attachment GB397R GB398R

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

6.6

Cleaning/disinfection

6.6.1

Product-specific safety instructions for the reprocessing procedure

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

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.

CAUTION

WARNING Risk of skin or tissue burns from blunt K-wires that have heated up! ► Only use K-wires that are in perfect condition. WARNING

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

Risk of injury due to loose seating of K-wire! ► Make certain that the K-wire is firmly seated. WARNING ► Position K-wire 1. ► Slowly increase the speed of motor unit 6 and insert K-wire 1 into the bone. ► To extend the K-wire 1 further out of the mini-Line K-wire attachment 4 if necessary:

– Release clamping lever 8 and readjust the length of K-wire 1. – Tighten down the clamping lever 8. ► When the K-wire 1 is correctly seated in the bone, release clamping lever 8 and remove mini-Line K-wire attachment 4 with motor unit 6 from the K-wire 1.

6.

Validated reprocessing procedure

6.1

General safety instructions

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

6.6.2

Validated cleaning and disinfection procedure

Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ Clean cannula with special cleaning brush

Chapter Manual cleaning/disinfecting and subsection:

(TA011327).

■ Chapter Manual cleaning and

■ When cleaning products with movable

wipe disinfecting

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

■ Drying phase: Use a lint-free cloth or compressed air for medical purposes

■ Hold the product in such a way that water

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.

cannot enter e.g. through couplings or adapters. Mechanical neutral or mild alkaline cleaning and thermal disinfecting

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

■ Follow instructions for use of Eccos® holder.

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

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.

6.7

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

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

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 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.

6.3

Dismantling prior to carrying out the reprocessing procedure

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.

6.7.1

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 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.

► Remove K-wire and motor from K-wire chuck.

Phase III ► Wipe all surfaces of the product with a single-use disinfectant wipe.

6.4

Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully.

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.

6.5

Preparation before cleaning

► Prior to first mechanical cleaning/disinfection process: Assemble Eccos holder GB674R in a suitable tray (e.g.,

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

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

6.8

8.

Mechanical cleaning/disinfecting

Troubleshooting list

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).

Malfunction

Detection

Cause

Remedy

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

K-wire cannot be inserted in the mini-Line K-wire attachment

K-wire diameter not matching the setting on the scale

Incorrect setting of miniLine K-wire attachment K-wire is crooked/bent

Set the adjustment sleeve to the correct Kwire diameter

6.8.1

K-wire not turning

K-wire diameter not matching the setting on the scale

Incorrect setting of miniLine K-wire attachment

Set the adjustment sleeve to the correct Kwire diameter

Clamping lever open

Clamping lever open

Close the clamping lever

Mechanical neutral or mild 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

Neutral:

9.

Technical Service

■ Concentrate:

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

– pH neutral – <5 % anionic surfactant

■ 0.5 %* working solution

WARNING

Mildly alkaline:

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

■ 0.5 % solution 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 neutral ► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

6.9

► 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 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Or in the US: Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 USA Aesculap Repair Hotline Phone: +1 (800) 214 -3392 Fax: +1 (314) 895 -4420 Other service addresses can be obtained from the address indicated above.

10.

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. ► Spray through the mini-Line handpiece with Aesculap-STERILIT oil spray GB600 with the appropriate adapter

GB600830 for approx. 1 s. ► 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.

6.10 Packaging

Accessories/Spare parts

Art. no.

Designation

GB600 (+Adapter GB600830)

Aesculap STERILIT oil spray

e.g., LX132

K-wires

GB674R

Eccos holder

TA011327

Cleaning brush

► 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

11.

Technical data

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

Designation

Class

GB397R/GB398R

mini-Line K-wire attachment

IIa

► 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

GB397R

– 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.

6.12 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.

GB398R

K-wire (∅ in mm)

0,6–2,5

0,6–2,5

Dimensions L x W x H (in mm)

87 x 27 x 125

109 x 27 x 129

Weight (in g)

approx. 185

approx. 190

Gear ratio

16:1

16:1

Drive speed in 1/min (K-wire)

max. 1,000

max. 1,000

To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters:

12.

Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

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.

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

7.

Disposal

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

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.

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

agency, see Technical Service.

13.

Distributor in the US/Contact in Canada for product information and complaints

Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 012604

01/14

V6

Änd.-Nr. 48673