macro-Line drill handpiece GB102R

4. Aesculap® macro-Line drill handpiece GB102R Legend 1 Threaded stud 2 Wrenching flats 3 Clamping lever 4 Coupling (for motor unit) 5 Centering lug 6 Face plate (motor unit) 7 Nib 8 Lubrication point (for clamping lever) 9 Fixing screw 10 Toothing 11 Sleeve 12 Ring 13 Tightening key 14 Flat wrench 15 Sleeve 16 Wrenching flats 17 HUDSON chuck adapter

Symbols on product and packages

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Before using the macro-Line drill handpiece and its accessories, visually check them to be sure they are not damaged. ► Use the macro-Line drill handpiece and its accessories only if they are in perfect condition.

5.

Working with the macro-Line drill handpiece GB102R

5.1

System set-up Damage to the handpiece due to incorrect handling or operation! ► Couple the handpiece only while the motor is inactive. CAUTION

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

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.

Connecting the macro-Line drill handpiece to the motor unit

Caution, general warning symbol Caution, see documentation supplied with the product

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

1.

Applicable to

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

at www.extranet.bbraun.com

2.

Safe handling

► 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 information 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

Art. no.

Designation

GB102R

macro-Line drill handpiece

GC523200

Flat wrench

3.2

Components required for operation

► Release clamping lever 3 towards the OPEN position. ► Push the handpiece onto centering lug 5 until the handpiece touches face plate 6 and nib 7 engages in the

recess on the handpiece. ► Tighten clamping lever 3 towards the CLOSE position.

Moving the clamping lever to be parallel with the motor unit ► Tighten clamping lever 3 hand-tight. ► Loosen fixing screw 9 with hexagon wrench TA004801 so that the toothing 10 disengages. ► Move clamping lever 3 to the intended position and engage toothing 10. ► Tighten fixing screw 9 with hexagon wrench TA004801.

Uncoupling the macro-Line drill handpiece from the motor unit ► Release clamping lever 3 towards the OPEN position. ► Remove the handpiece.

Mounting chuck adapter GB103R/GB105R/GB106R The chuck adapters GB103R/GB105R can be used to clamp any smooth or trihedral tool shafts. GB103R ► Turn the chuck adapter onto threaded stud 1, hold ring 12, and turn sleeve 11. ► To fasten the chuck adapter: Apply flat wrench 14 at wrenching flats 2 and tighten clockwise. GB105R ► Turn the chuck adapter onto threaded stud 1. ► Apply and hold flat wrench 14 at wrenching flats 2. ► To fasten the chuck adapter: Turn the chuck adapter clockwise with flat wrench 14. GB106R ► Turn the HUDSON chuck adapter 17 onto threaded stud 1. ► To fasten the HUDSON chuck adapter 17: Apply and hold flat wrench 14 at wrenching flats 2. ► Apply flat wrench 14 at wrenching flats 16 and tighten clockwise.

One of the following components is necessary for operation:

Dismounting chuck adapter GB103R/GB105R/GB106R

Art. no.

Designation

GA156

Flexible shaft (1.6 m) with Elan EC and foot control

GB103R ► Apply and hold flat wrench 14 at wrenching flats 2. ► Open the chuck adapter completely and continue turning it until it becomes detached from threaded stud 1. ► Remove the chuck adapter from threaded stud 1.

GA172

Flexible shaft (2.1 m) with Elan EC and foot control

GA200

AIRLAN pneumatic motor

The following attachments can be coupled to the handpiece:

GB105R ► Apply and hold flat wrench 14 at wrenching flats 2. ► To loosen the chuck adapter: Turn the chuck adapter counterclockwise with tightening key 13. ► Remove the chuck adapter from threaded stud 1. GB106R ► To loosen the HUDSON chuck adapter 17: Apply and hold flat wrench 14 at wrenching flats 2. ► Apply flat wrench 14 at wrenching flats 16 and turn counterclockwise. ► Remove the HUDSON chuck adapter 17 from threaded stud 1.

Art. no.

Designation

GB103R

Keyless chuck adapter with 0.8 mm to 6.35 mm tightening range

5.2

GB105R

Chuck adapter with key with 0 mm to 6.35 mm tightening range

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

GB106R

HUDSON chuck adapter with 0 mm to 6.35 mm tightening range

Test run ► Check that the macro-Line drill handpiece is seated properly. ► Briefly run the macro-Line drill handpiece at maximum speed. Check for proper and reliable functioning.

3.3

Intended use

The macro-Line drill handpiece is used for drilling and reaming in osteosynthesis procedures and for trepanning in neurosurgery.

3.4

Operating principle

The macro-Line drill handpiece reduces the drive speed by the ratio 10:1 (e. g, motor speed 15 000 rpm, drill speed 1 500 rpm).

Function checks

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.

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 – be approved for plastic material and high-grade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time.

CAUTION

WARNING

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

► 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.

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. WARNING

Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning instruments 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-

GB106R

pressed air for medical purposes

► To couple and uncouple the HUDSON chuck adapter 17: Pull sleeve 15 forward.

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.

■ 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.)

6.7

Manual cleaning/disinfecting

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

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.

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

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

Manual cleaning and wipe 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. 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

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

-

-

-

-

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

infecting solution.

Dismantling prior to carrying out the reprocessing procedure

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

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

6.8 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.

6.6

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 disinfecting cycle, lubricate the product at threaded stud 1, the lubrication point (for

clamping lever) 8, and the sliding points of the chuck adapter with one drop of STERILIT Power Systems oil from drip lubricator GA059. ► 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.

Cleaning/disinfection 6.9

Product-specific safety instructions for the reprocessing procedure Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. CAUTION Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent. CAUTION

Packaging

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

6.10 Steam sterilization

12.

► Prior to sterilization, remove any tools and adapters and uncouple the handpiece from the motor unit. ► 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).

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

► Validated sterilization process

– Disassemble the instrument – 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 instruments 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.

6.11 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.

8.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Intense/loud running noise

Motor unit can be pulled out from the handpiece

Motor unit not coupled correctly

Couple the motor unit correctly, see Connecting the macro-Line drill handpiece to the motor unit

Handpiece hot

Gearing worn

Have repaired by manufacturer

Lack of power at handpiece

Intense/loud running noise

Gearing worn

Have repaired by manufacturer

Inadequate power at handpiece

Intense/loud running noise

Blunt tool

Replace the tool

-

Motor unit not running correctly

See instructions for use of the motor unit

Coupling parts broken

Coupling defective

Have repaired by manufacturer

Motor unit running, but not powering the handpiece

Defective gearing

Have repaired by manufacturer

Tool not moving

9.

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

► For service and repairs, please contact your national B. Braun/Aesculapp 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] Other service addresses can be obtained from the address indicated above.

10.

Accessories/Spare parts

Art. no.

Designation

GA031R

Tightening key

GA059

STERILIT Power Systems drip lubricator

GB032207

Fixing screw

GB103R

Keyless universal chuck (0.8–6.35 mm)

GB105R

Universal chuck, incl. GA031R (0–6.35 mm)

GB106R

HUDSON chuck adapter

GC523200

Flat wrench

TA004801

Hexagon wrench

11.

Technical data

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

Designation

Class

GB102R

macro-Line drill handpiece GB102R

IIa

Designation

Disposal

Value

Size

∅ 40 mm

Length

125 mm

Length

approx. 320 g

Maximum motor unit speed

20 000 rpm

Gear ratio

10:1

agency, see Technical Service. TA-Nr. 005333

01/14

V6

Änd.-Nr. 48673