micro-Line angled handpiece GB110, GB111, GB113, GB114R

Aesculap® micro-Line micro-Line angled handpiece GB110, GB111, GB113, GB114R Legend 1 Spray nozzle 2 Tension ring 3 Rotary direction for opening 4 Grip 5 Conical sheath 6 Cover plate 7 Centering lug 8 Release mechanism with button 9 Aesculap-STERILIT-Power-Systems oil spray and micro-Line adapter 10 Attachment (angle head, attachment with Imperator bearing, K-wire head)

microLine angled handpiece

Gear ratio

GB110

1:1

Allowable motor drive speed ranges

Overall gear ratio

Tool speed range (1/min)

Recommended application

GB154 (2:1)

0-3 000

2:1

0-1 500

Applying Kirschner wire

GB119 (2:1)

0-5 000

2:1

0-2 500

Drilling

GB173 (1:1)

0-40 000

1:1

0-40 000

Drilling, reaming, grinding

0-40 000

2:1

0-20 000

Drilling, reaming, grinding

0-40 000

GB194 (2:1) GB111

4:1

Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product GB113

1.

When used with attachment (transmission)

0-40 000 GB154 (2:1)

0-12 000

8:1

0-1 500

Applying Kirschner wire

GB119 (2:1)

0-20 000

8:1

0-2 500

Drilling

GB173 (1:1)

0-40 000

4:1

0-5 000

Drilling

GB194 (2:1)

0-40 000

8:1

0-5 000

Drilling

30:1

Applicable to

► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

0-20 000 GB119 (2:1)

0-20 000

60:1

0-333

Tapping, screwing in and out

GB173 (1:1)

0-20 000

30:1

0-666

Drilling, using trephines

GB194 (2:1)

0-20 000

60:1

0-333

Tapping, screwing in and out

at www.extranet.bbraun.com GB114R

2.

CAUTION Federal law restricts this device to sale by, or on order of a physician! ► 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. ► Only use drive unit with DIN 13940/ISO 3964 coupling. ► To prevent damage caused by improper setup or operation, and in order 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. ► 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

3.1

Components required for operation

0-20 000

1:2

0-40 000

Drilling, reaming, grinding

GB194 (2:1)

0-20 000

1:1

0-20 000

Drilling, reaming, grinding

5.

Working with the micro-Line angled handpiece

5.1

System set-up

Note Products marked as unsterile must be sterilized, prior to use, according to respective instructions, see Steam sterilization. Risk of injury due to inadvertent activation of the drive unit/motor! ► Secure drive units/motors that are not in active operation against inadvertent activation by foot or hand controls.

Intended use

Risk of injury and damage to the instrument components if the micro-Line angled handpiece is not attached properly! ► Make certain the micro-Line angled handpiece is coupled correctly. WARNING Risk of injury due to accidental activation of drive unit! ► Change the tool only when the drive unit is disconnected. WARNING Risk of contamination and infection if unsterile components are used in the sterile area! ► Use only sterile or sterilized parts in the sterile area. WARNING

The micro-Line angled handpieces GB110, GB111, GB113 and GB114R are used in connection with application-specific attachments for drilling and reaming procedures in microsurgery and dental surgery.

3.3

0-40 000 GB173 (1:1)

WARNING

When putting the micro-Line angled handpieces into operation, the following components are required: ■ Attachment with tool/Kirschner wire* ■ Optional spray nozzle GB117R for use with microsurgery attachment GB173 ■ Irrigation fluid pump if applicable *The attachments angle heads GB119 and GB194, Kirschner wire head? GB154 and micro-Line attachment with Imperator bearing GB173 are clamped in the micro-Line angled handpiece without a key. The following motor drives are suitable for use with the micro-Line angled handpieces: ■ microspeed uni motor GD678/GD679 ■ ELAN-EC GA830, GA835, with micro flexible shaft GA176 (180 cm) or GA173 (230 cm) ■ Microtron-EC GD631 with motor GD622 ■ Microlan GA502R, GA553R

3.2

1:2

Safe handling

Operating principle

The micro-Line angled handpieces are powered by a drive unit (coupling acc. to DIN 13940/ISO 3964). The motor drive speed is transmitted in various ratios of transmissions to the micro-Line angled handpiece and, through this, to the attachments.

WARNING

Risk of burns to the patient caused by blunt tools or lack/inadequacy of maintenance of handpieces! ► Prior to each use and before clamping in place, check the tools for any wear or damage.

Connecting the accessories

GB111

1 green ring

ratio 4:1

GB113

2 green rings

ratio 30:1

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 address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service.

GB114R

2 red rings

ratio 1:2

Connecting the spray nozzle GB117R

GB110

4.

1 blue ring

ratio 1:1

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Prior to using the micro-Line angled handpiece and its accessories, check for visible damage. ► Use the micro-Line angled handpiece and its accessories only if they are in perfect condition. ► Ensure that the maximum allowable motor drive speed range for each of the micro-Line angled handpieces is not exceeded.

4.1

Allowable motor drive speed ranges

Only the motor drive speed ranges shown in the table below are allowable when using the micro-Line angled handpieces with attachments. Exceeding these speed ranges may considerably shorten the life of the components or cause them to fail.

The micro-Line angled handpiece can be used in combination with GB173 with the spray nozzle 1 fitted. ► Push the spray nozzle onto the tension ring 2 from the front. ► Secure the irrigation tube to the tube connector.

Connecting attachments to the micro-Line angled handpiece Coupling: ► Rotate tension ring 2 in the direction of arrow 3 as far as it will go, and hold it there. ► Insert attachment 10 to the positive stop and release tension ring 2. Note Attachment 0 can be inserted in two positions. Ensure that the components are securely attached to each other: ► Pull at attachment 10. Ensure that there is no play in the attachment 10 and that it is firmly seated in its opening. Uncoupling: ► Rotate the tension ring 2 in the direction of the arrow 3 and remove the attachment 10.

Connecting the micro-Line angled handpieces to the motor drive Coupling: ► Push centering lug 7 into the coupling of the micro-Line angled handpiece so that the drive unit/motor engages audibly. ► Pull at the drive unit/motor to check that it is coupled correctly. This completes the coupling of the drive unit/motor. Ensure that the components are securely attached to each other: ► Pull at attachment 10. Uncoupling: ► Actuate release mechanism 8 at the drive unit by pressing it and detach the micro-Line angled handpiece from the drive unit.

5.2

Function checks

CAUTION

Damage to the product due to incorrect handling or operation! ► The product must only be coupled while the motor is inactive. ► Make certain that the maximum rotational speed of 18 000 rpm is correctly set on the drive unit.

► Carry out a trial run with an attachment coupled to the micro-Line angled handpiece prior to each use:

– Check attachment 10 for secure seating in the micro-Line angled handpiece. – Briefly run the micro-Line angled handpiece at maximum speed. – Only use micro-Line angled handpieces in perfect condition, i.e. ones which do not make any atypical sounds and which do not oscillate unduly when operated. ► If applicable, check the irrigation set for leaks or blockage: – To conduct this test, switch on the irrigation pump.

5.3

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

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

► Disassemble the product immediately after use, as described in the respective instructions for use.

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.

6.5

Preparation before cleaning

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use. ► Prior to the first mechanical cleaning/disinfection process, mount Eccos holder GB681R or GB682R in a suitable

tray (e.g. JF214R).

6.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

WARNING

WARNING

CAUTION

Risk of burns to patient and user due to hot motor/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.

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 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.

WARNING

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 to the patient due to inadvertent slipping/rattling of the tool! ► Only apply minimal force when working laterally with the micro-Line angled handpiece.

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

WARNING

6.

Note The indicated drying temperature is a guide temperature only. It must be checked taking into account the specific conditions (e.g. load) and if applicable adjusted. micro-Line angled handpieces ► 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. Tools ► Carry out ultrasound cleaning: – as an effective mechanical supplement to manual cleaning/disinfecting. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/ disinfecting. – as an integrated mechanical support measure for mechanical cleaning/disinfecting. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting.

Validated cleaning and disinfection procedure Risk of contamination and infection if surgical gloves are damaged by a sharp tool! ► Do not touch the cutting edges of the tool, neither when changing tools nor during use.

Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with movable

Chapter Manual cleaning/disinfecting and subsection:

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 com-

Validated reprocessing procedure

pressed air for medical purposes

■ Ensure that the product is positioned in 6.1

such a way that water will not enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered the product inadvertently.)

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.

Mechanical alkaline cleaning and thermal disinfecting

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

the Eccos holder.

■ Follow the instructions for use of the Eccos

6.7

cleaning and thermal disinfecting

Manual cleaning/disinfecting

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

Manual cleaning and wipe disinfecting

6.2

General information

■ Chapter Mechanical alkaline

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

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.

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.

Chapter Mechanical cleaning/ disinfecting and subsection:

holder.

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.

■ Insert the product in its proper position in

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

To achieve a sterility assurance level of 10-6 , Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters*

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.

Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

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

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

6.13 Storage

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.

6.8

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

7.

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.

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.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

micro-Line angled handpiece does not run

Motor drive not running

Motor drive not switched on

Switch on motor drive

Motor drive defective

Check motor drive as explained in the instructions for use

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

T [°C/°F]

t [min]

Water quality

Chemical/Note

Attachment cannot be coupled/changed

Tension ring does not rotate freely or does not rotate at all

Tension ring jammed

Have the attachment repaired by the manufacturer

I

Prerinse

<25/77

3

D–W

-

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

micro-Line angled handpiece vibrates

Atypical sound while operating

Defective bearing

II

Have micro-Line angled handpiece repaired by the manufacturer

The motor drive cannot be coupled to the handpiece

Intracoupler jammed

Defective Intra-coupling

Have motor drive repaired by the manufacturer

micro-Line angled handpiece becomes hot during operation

Rapid temperature rise

Worn gear or bearing

Have micro-Line angled handpiece repaired by the manufacturer

Phase

– 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

9.

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

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

D–W: FD–W:

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

6.9

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. ► Spray through the product with Aesculap-STERILIT oil spray GB600 with adapter GB600810 for approx. 1 s. ► 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 an extended period of non-use, always store attachments cleaned and dried according to the instruc-

tions.

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 Note The product can be sterilized either in disassembled or in assembled condition. GB114R cannot be disassembled. ► 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 – 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.

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.

Technical Service

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] 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.

Accessories/Spare parts

Art. no.

Designation

GB117R

Spray nozzle

GB119

micro-Line angle head 2:1

GB600

Aesculap STERILIT Power-Systems oil spray

GB600810

STERILIT adapter

GB154

micro-Line K-wire head 2:1

GB164

Tensioning device

GB173

micro-Line attachment with Imperator bearing

GB681R or GB682R

Eccos holder for micro-Line angled handpieces GB110, GB111, GB113 and GB114R

GB459R

Eccos mounting set for holders

TA010251

Instructions for use for GB110, GB111, GB113 and GB114R

11.

Technical data

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

Designation

Class

GB110 GB111 GB113 GB114R

micro-Line angled handpiece

IIa

micro-Line angled handpiece

Gear ratio

Max. motor speed in rpm

Max. motor speed in rpm

Weight in grams

Class

GB110

1:1

40 000

40 000

72

IIa

GB111

4:1

40 000

10 000

72

IIa

GB113

30:1

20 000

666

72

IIa

GB114R

1:2

40 000

80 000

64

IIa

11.1 Ambient conditions Operation

Storage and transport

Temperature

Relative humidity

Atmospheric pressure

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. 010251

01/14

V6

Änd.-Nr. 48673