Angular heads, Kirschner wire chuck, microsurgery adapter

Determining the tool speed The speed of the coupled tool can be determined from the allowable motor drive speed divided by the overall transmission ratio. Example: Angular head GB119 (transmission ratio 2:1) in combination with surgical bottom part GB111 (transmission ratio 4:1, motor drive speed 20 000 1/min): With a motor drive speed of 20 000 1/min on the surgical bottom part, the angular head will run at 5 000 1/min. A tool coupled to the angular head will run at 2 500 1/min.

WARNING

5.2

WARNING

Risk of injury to user and/or patient from bent or broken tools! ► Check tools for mechanical damage to the cutting edges, as well as for wear, warping, cracks and corrosion prior to insertion. ► Use tools only if they are in perfect condition. ► Ensure that all tool shafts meet DIN 13950 and ISO 1797 standards.

Insert the tool in the angular head GB119 and GB194 with interior cooling ► Push the lever flap 1 to the right. ► Insert the tool into the insertion bore 3 as far as it will go, rotating it slightly. ► Push the lever flap 1 to the left. The tool is clamped in now. ► Pull at the tool to check that it is securely clamped in place. Insert the tool in the microsurgery adapter GB173 for tools with shafts 2.35 mm in diameter Use the tensioning device 4 (GB164) to tighten down the tool. ► Insert the tool as far as it will go into the open microsurgery adapter (GB173). ► Place the microsurgery tool, with the adapter, in the tensioning device (GB164) 4. ► Close the tensioning device 4. ► Rotate the milled screw 5 in a clockwise direction until the tool is securely tightened in the microsurgery adapter. ► To remove the tool, rotate the milled screw 5 in a counterclockwise direction until the tool can be removed from the microsurgery adapter. Insert the Kirschner wire in the Kirschner wire chuck GB154 for Kirschner wires with a diameter of 0.61.5 mm. ► Insert the Kirschner wire from above in the borehole in the knurled nut 6. ► Hold onto the clamping ring on the knurl 7. ► Rotate the knurled nut 6 in a clockwise direction, tightening the Kirschner wire at the desired length. ► To remove the Kirschner wire, rotate the knurled nut 6 in a counterclockwise direction until the Kirschner wire can be removed.

Function checks

Before each use, a test run of the surgical bottom part must be performed with an attachment coupled to it. ► Check to ensure that the attachment is properly seated in the surgical bottom part. ► Briefly run the surgical bottom part at maximum speed. ► Only use products in perfect condition, i.e. ones which do not make any atypical sounds and which do not oscillate unduly when operated. ► Check to ensure that the seals on the tube fittings are tight and that the fittings are not constricting flow. To conduct this test, switch on the irrigation pump.

5.4

Risk of contamination and infection due to sharp-edged tool that damages the surgical glove! ► Do not touch the tool edges, neither when replacing the tool nor when using it.

Inserting the tool into the attachment

WARNING

5.3

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

Safe operation

WARNING

WARNING

Risk of burns to patient and user, caused by hot tool! ► Only use sharp tools. ► Use irrigation for cooling the tool and to remove any chipping. ► Observe the correct reaming direction. ► Put down the hot tool beyond reach of the patient. ► Use a cloth to protect against burns when changing the tool. Risk of injury and material damage due to inappropriate use of handpieces or motors! ► Always follow the safety advice and information given in the instructions for use of the handpieces and motors. ► Do not exceed the specified maximum motor speed. Risk of injury and overheating of bones and tissues (necrosis) from tools that are not cooled while being used! ► Use an appropriate coolant/irrigation fluid, e.g., physiologic saline.

WARNING

WARNING

Risk of injury from metal cuttings! Restriction of the tool! ► Only separate and remove bones. Ensure that no instruments are damaged in the operating field.

► Cool tools down with an external coolant supply. ► Use only physiologic, sterile coolant. ► Ensure that there is no air in the coolant flow pathway.

Working with the Kirschner wire chuck GB154 ► Position the Kirschner wire and then insert it by gradually increasing motor drive speed. ► If the Kirschner wire needs to be reinserted, proceed as follows:

– – – – –

Working with the angular head GB119/GB194 and the microsurgery adapter GB173 ► Prepare bones in accordance with the relevant indications using a tool such as a drill or a burr.

6.

Validated reprocessing procedure

6.1

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. 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

WARNING

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 Risk of injury from flying metal filings or broken tools when rotating tools are in use! ► Always wear protective gear (goggles etc.).

Switch off the motor drive. Loosen the clamping ring on the Kirschner wire chuck. Push the attachment forward. Tighten the Kirschner wire. Once the Kirschner wire has been correctly positioned, loosen the clamping ring and then separate the attachment from the Kirschner wire.

Dismantling prior to carrying out the reprocessing procedure

► Uncouple the attachments from the surgical bottom parts and remove the tool.

6.4

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.

Risk of injury from broken tools! ► Do not distort, twist or bend the tool.

6.5

Preparation before cleaning

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

WARNING

6.6 Risk of injury and/or damage to the tool and/or motor drive if drape or other fabrics are cut through! ► Keep rotating tools away from drape and other fabrics.

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

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

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 – are approved for plastic material and high-grade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable temperature of 60 °C.

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

Mechanical alkaline cleaning and thermal disinfecting

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.

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:

► 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.

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with movable hinges,

Chapter Manual cleaning/ disinfecting and subsection:

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

■ Rinse the irrigation tube at the angular heads with

■ Chapter Manual cleaning and wipe disinfecting

demineralized water.

■ Drying phase: Use a lint-free cloth or medical

– 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

compressed air.

■ 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.)

■ Place the product in a tray that is suitable for

Mechanical alkaline cleaning and thermal disinfecting

cleaning (avoiding rinsing blind spots).

Chapter Mechanical cleaning/disinfecting and subsection:

D–W: FD–W:

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

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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

6.9 6.7

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 motor/handpiece with Aesculap-STERILIT oil spray GB600 with adapter GB600810 for approx.

Manual cleaning/disinfecting Danger to the patient! ► Only mechanically clean the product.

1 second.

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

► 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. ► Prior to extended periods of non-use: Store attachments cleaned, maintained and dried according to the instruc-

tions.

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

6.10 Packaging

Manual cleaning and wipe disinfecting

► Always observe the instructions for use of packaging and storage devices. ► Place the product on a tray in such a way that it is protected against damage. Ensure that any cutting edges

present are protected. Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

I

Cleaning

RT (cold)

-

-

D–W

-

6.11 Steam sterilization

II

Drying

RT

-

-

-

-

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

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

► Validated sterilization process

IV

Final rinse

RT (cold)

0.5

-

FD-W

-

V

Drying

RT

-

-

-

-

opening any valves and faucets).

D–W: FD–W: RT:

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

– Disassemble the product – 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 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.

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.

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

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

Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

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.

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

*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.

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

6.13 Storage

6.8

7.

Mechanical cleaning/disinfecting

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

Maintenance

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).

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.

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

Changing the spray nozzle on the angular head with interior cooling GB194 ► Remove the irrigation tube 2 from the lever flap fastening pins 1. ► Insert the spray nozzle irrigation tube into the borehole of the angular head. ► Snap (i.e., engage) the fastening pins into the lever flap borehole 1.

8.

Troubleshooting list

11.

All attachments

Technical data

Classification acc. to Directive 93/42/EEC

Malfunction

Detection

Cause

Remedy

Art. no.

Designation

Class

Deficient cutting performance

Cutting edges worn

Tool

Install a new tool

GB119

micro-Line angular head 2:1

IIa

Transmission on attachment or surgical bottom part malfunctions

Attachment, surgical bottom part

Have product repaired by the manufacturer

GB154

micro-Line K-wire head 2:1

IIa

GB173

micro-Line attachment with Imperator bearing

IIa

Motor drive defective

Motor drive

Check motor drive as explained in the instructions for use

GB194

micro-Line angular head 2:1 with cooling

IIa

Tensioning device does not rotate freely or does not rotate at all

Tensioning device jammed

Have product repaired by the manufacturer

Attachment

Ratio

Weight in grams

Max. motor speed in 1/min

Max. output speed in 1/min

GB119

2:1

12

5 000

2 500

Tool/attachment does not rotate freely or does not rotate at all

Tool/attachment jammed

Have product repaired by the manufacturer

GB154

2:1

15

3 000

1 500

GB173

1:1

7

40 000

40 000

GB194

2:1

12

40 000

20 000

Tool/attachment cannot be changed

Angular heads GB119, GB194, Kirschner wire chuck GB154 and microsurgery adapter GB173 Malfunction

Detection

Cause

Remedy

Tool/Kirschner wire does not rotate

Tool/Kirschner wire is loose

Insufficient tension in tensioning device

Close the tensioning device

Atypical sound while operating

Attachment

Have product repaired by the manufacturer

Motor drive defective

Motor drive

Check motor drive as explained in the instructions for use

9.

Technical Service

11.1 Ambient conditions Operation

Storage and transport

Temperature

Relative humidity

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

Atmospheric pressure

► 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] 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.

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 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. 010253

10.

Accessories/Spare parts

Art. no.

Designation

GB110

Surgical bottom part (1:1)

GB111

Surgical bottom part (4:1)

GB113

Surgical bottom part (30:1)

GB114

Surgical bottom part (1:2)

GB117R

Spray nozzle for surgical bottom part

GB194/201

Replacement spray nozzle for GB194

GB112/250

Injector needle for GB119

GB194/250

Injector needle for GB194

GB600

Aesculap STERILIT oil spray

GB600810

STERILIT micro-Line adapter

GB164

Tensioning device

GD100

Instrument stands

TA010253

Instructions for use for GB119, GB154, GB173 and GB194

01/14

V6

Änd.-Nr. 48673