Micro drill handpiece GB169R

Aesculap® Micro drill handpiece GB169R

5.

Working with the micro drill handpiece GB169R

5.1

System set-up

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

Legend

Risk of injury due to accidental activation of the motor! ► Change tools only with the motor uncoupled.

1 Threaded stud 2 Collar 3 Handpiece 4 Centering lug 5 Release 6 Cover plate 7 Nozzle 8 Connector for irrigation tube 9 Spray nozzle 10 Key 11 Wrenching flats 12 Coupling 13 Flat wrench 14 Sleeve 15 Ring 16 Ring 17 HUDSON chuck adapter 18 Flat wrench

WARNING Risk of contamination and infection caused by unsterile components in the sterile area! ► Use only sterile or sterilized parts in the sterile area. WARNING

CAUTION

Either the keyless drill chuck GB103R (with 0.8 mm to 6.35 mm clamping range) and GB104R (with 0 mm to 3 mm clamping range) or the drill chuck with key GB105R (with 0 mm to 6.35 mm clamping range) and GB108R (with 0 mm to 4 mm clamping range) can be screwed onto the threaded stud 1. These chucks can be used to clamp any smooth or trihedral tool shafts. The HUDSON chuck adapter GB106R can also be screwed onto the threaded stud 1.

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

1.

Damage to the product due to incorrect handling or operation! ► Couple the product only while the motor is inactive. ► Make certain that the maximum speed of 18 000 1/min is correctly set on the motor unit.

Applicable to

Connecting the accessories 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.

Coupling a motor unit

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

at www.extranet.bbraun.com

2.

Damage to the drill handpiece due to incorrect handling or operation! ► Couple the drill handpiece only while the motor is inactive.

Safe handling

CAUTION

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. ► 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

Scope of supply

Note Do not exceed a maximum motor speed of 18 000 1/min. The motor can be driven with the flexible shaft GA176 or another drive system (e.g. micro motor with appropriate required power and connection according to DIN 13940). ► Push the handpiece 3 onto centering lug 4 until handpiece 3 touches cover plate 6 and snaps into position.

Uncoupling the motor unit ► Press the release 4 and pull the handpiece off.

Mounting chuck adapter GB103R/GB104R ► Hold ring 15 and turn sleeve 14.

Mounting chuck adapter GB105R/GB108R ► Turn the chuck adapter onto threaded stud 1.

Mounting HUDSON chuck adapter GB106R

Designation

Art. no.

► Pull ring 16forward. ► Screw on HUDSON chuck adapter.

Micro drill handpiece

GB169R

Mounting the spray nozzle

Flat wrench

GC523/200

► Attach spray nozzle 9 to collar 2. ► Attach irrigation tube onto connector for irrigation tube 8 and gently bend the nozzle 7 in the required direction.

Key

GA031R

Key

GA062R

3.2 Components required for operation ■ Micro drill handpiece GB169R ■ Flexible shaft GA176 - or - drive system, e.g. micro motor with the necessary power and connection according to DIN 13940 ■ Drill chuck GB103R - or ■ Drill chuck GB104R - or ■ Drill chuck GB105R - or ■ HUDSON chuck GB106R - or ■ Drill chuck GB108R

3.3

Dismounting chuck adapter GB103R/GB104R ► Apply and hold flat wrench 13 at wrenching flats 11. ► Open the chuck fully and continue to turn it firmly. ► Remove the chuck adapter.

Dismounting chuck adapter GB105R/GB108R ► Apply the key 10 and turn left. ► Remove the chuck adapter.

Dismounting HUDSON chuck adapter GB106R/ ► Pull ring 16 forward. ► Apply and hold flat wrench 13 at wrenching flats 11. ► Apply the flat wrench 18 at the wrenching flats of the HUDSON chuck adapter 17 and turn left. ► Remove HUDSON chuck adapter.

Intended use

The micro drill handpiece is used for drilling and reaming in osteosynthesis procedures and for trepanning in neurosurgery.

5.2

3.4

► Make certain that the micro drill handpiece is securely seated. ► Briefly run the micro drill handpiece at maximum speed. Check for proper and reliable functioning.

Operating principle

The micro drill handpiece reduces the drive speed by the ratio 20:1 (e.g., motor speed 15,000 rpm, drill speed 1 500 1/ min).

4.

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Prior to use, inspect the micro drill handpiece and its accessories for any visible damage. ► Use the micro drill handpiece and its accessories only if they are in perfect condition.

Function checks

Note The following function checks must be carried out prior to every surgical application of the product!

5.3

Safe operation Risk of burns to patient and user due to hot motor/hot tool! ► Put down the motor/hot tool beyond reach of the patient. ► Use a cloth to protect against burns when changing the motor or tool.

6.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure 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.

WARNING

WARNING

CAUTION

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. Injuries to tissue if the tool is unintentionally released or moved! ► Make certain that the tool is correctly engaged in the chuck adapter and that the tool is seated tightly.

WARNING

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

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

Validated cleaning and disinfection procedure WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with movable

Chapter Manual cleaning/disinfecting and subsection:

WARNING

wipe disinfecting

pressed 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.)

WARNING

Validated reprocessing procedure

6.1

■ Chapter Manual cleaning and

■ Drying phase: Use a lint-free cloth or comRisk of infection and contamination due to aerosol formation! ► Take appropriate protective measures, e.g., watertight protective clothing, face mask, protective goggles, and a suction extraction system.

6.

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

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

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.

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

■ Follow the instructions for use of the Eccos

Chapter Mechanical cleaning/ disinfecting and subsection:

■ Chapter Mechanical neutral

holder.

6.7

or mild alkaline cleaning and thermal disinfecting

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.

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.

Manual cleaning and wipe disinfecting Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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

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

-

-

-

-

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.

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. 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.

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

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

6.4

6.8

6.3

Dismantling prior to carrying out the reprocessing procedure

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 the Eccos holder GB682R in a suitable tray (e.g.

JF214R).

Mechanical cleaning/disinfecting

Note The cleaning and disinfecting machine 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.

8.

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Troubleshooting list

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

Malfunction

Detection

Cause

Remedy

Intense/loud running noise

Motor unit not coupled correctly

Motor unit can be pulled out from the handpiece

Couple the motor unit correctly, see Coupling a motor unit

Gearing worn

Handpiece hot

Have repaired by manufacturer

Lack of power at handpiece

Gearing worn

Intense/loud running noise

Have repaired by manufacturer

Inadequate power at handpiece

Blunt tool

Intense/loud running noise

Replace the tool

Motor unit not running correctly

–

See instructions for use of the motor unit

Coupling defective

Coupling parts broken

Have repaired by manufacturer

Defective gearings

Motor unit running, but not powering the handpiece

Have repaired by manufacturer

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

Tool not moving

9.

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

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

D–W: FD–W:

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.

► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

6.9

Technical Service

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. ► After every cleaning and disinfection process, spray through the product with Aesculap STERILIT oil spray GB600

with adapter GB600810 for approx. 1 second. When doing so, keep the handpiece covered with cellulose, a cloth or some other appropriate material. ► 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 instructions.

6.10 Packaging ► Follow the instructions for use for the applied packaging and storage systems (e.g. instructions for use TA009721

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.

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.

10.

Accessories/Spare parts

Art. no.

Designation

GA176

Micro-elliptical shaft

GB103R

Drill chuck

GB104R

Drill chuck

Note The product can be sterilized either in disassembled or in assembled condition.

GB105R

Drill chuck

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

GB106R

HUDSON chuck

GB108R

Drill chuck

GB031R

Key for GB105R

6.11 Steam sterilization Note The product may only be sterilized when dismantled.

opening any valves and faucets). ► Validated sterilization process

– 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.

GB062R

Key for GB108R

GA523200

Flat wrench for GB169R and GB106R

TA006449

Instructions for use GB169R

GB600

Aesculap STERILIT oil spray

GB600810

STERILIT adapter

GB682R

Eccos holder

GB459R

Eccos mounting set for holders

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

11.

Technical data

Classification acc. to Directive 93/42/EEC *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.

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.

Art. no.

Designation

Class

GB169R

Micro drill handpiece

IIa

Weight

280 g

Max. motor speed

18 000 1/min

Gear ratio

20:1

Tool coupling

Three jaw chuck adapter/HUDSON chuck adapter

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. 006449

04/13

V6

Änd.-Nr. 46955