macro-Line angled handpiece with Harris adapter GB121R

Couple the macro-Line angled handpiece GB121R to the motor unit Damage to the handpiece due to incorrect handling or operation! ► Couple the handpiece only while the motor is inactive.

Aesculap® macro-Line macro-Line angled handpiece with Harris adapter GB121R Legend 1 Driver flats 2 Harris shaft 3 Pull back unlocking sleeve 4 Clamping lever 5 Centering lug 6 Face plate (motor unit) 7 Nib 8 Lubrication point (for clamping lever) 9 Denticulation 10 Fixing screw 11 Harris coupling 12 Centering lug 13 Coupling (for motor unit)

CAUTION ► Release clamping lever 4 towards the OPEN position. ► Push the handpiece onto centering lug 5 until the handpiece touches face plate 6 and lug 7 engages in the recess

at the handpiece. ► Tighten clamping lever 4 towards the CLOSE position.

Moving the clamping lever to be parallel with the macro-Line angled handpiece GB121R ► Tighten down the clamping lever 4. ► Undo fixing screw 10 with hexagon wrench GB020R until the denticulation 9 disengages. ► Move clamping lever 4 to position it parallel to the handpiece. ► Engage denticulation 9 and tighten clamping bolt 10.

Decouple macro-Line angled handpiece GB121R ► Release clamping lever 4 towards the OPEN position. ► Remove the angled handpiece.

Couple reamers

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

Note Reamers, burrs and bone cement syringes with Harris shaft can be coupled directly. ► Slide back unlocking sleeve 3. ► Insert Harris shaft 2 and turn it slightly, until the driver flats 1 engage in Harris coupling 11. ► Unlocking sleeve 3 slides back into locking position.

Uncouple reamers

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

► Clean the new product after removing its transport packaging and 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 man-

ufacturer 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.

► Slide back unlocking sleeve 3. ► Remove Harris shaft 2.

5.2

Function checks

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

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

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. WARNING

3.

Product description

3.1

Scope of supply

Art. no.

Designation

GB121R

macro-Line angled handpiece with Harris adapter

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.

3.2

Components required for operation WARNING

One of the following components is necessary for operation of the macro-Line angled handpiece with the Harris adapter GB121R: Art. no.

Designation

GA156

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

GA172

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

GA200

AIRLAN pneumatic motor

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

3.3

Intended use

The macro-Line angled handpiece with Harris adapter GB121R is used for acetabular reaming and intramedullary drilling. The handpiece can also drive bone cement syringes with Harris shaft.

3.4

Operating principle

The macro-Line angled handpiece with Harris adapter GB121R reduces the motor speed by the ratio 135:1.

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 macro-Line angled handpiece and its accessories for any visible damage. ► Use the macro-Line angled handpiece and its accessories only if they are in perfect condition.

5.

5.1

Working with the macro-Line angled handpiece with Harris adapter GB121R System set-up

Note Products marked as unsterile must be sterilized, prior to use, according to 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.

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

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

► 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

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.

6.8

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, lubricate the product at the lubrication points 8, bore in the coupling 13,

Preparation before cleaning

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

Harris coupling 11 and centering lug 5/12 with a drop of STERILIT Power Systems drip lubricator GA059.

6.6

► 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

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.

6.9

Packaging

► Always observe the instructions for use of packaging and storage devices. ► 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 ► 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). ► 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

CAUTION

opening any valves and faucets). 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

► 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

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

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

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

7.

8.

Validated procedure

Special features

Manual cleaning and wipe disinfection

■ When cleaning instruments with movable

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.

Troubleshooting list

Reference

Chapter Manual cleaning/disinfecting and subsection:

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

Malfunction

Detection

Cause

Remedy

Intense/loud running noise

Motor unit can be pulled out from the macro-Line angled handpiece

Motor unit not coupled correctly

Couple the motor unit correctly, see Couple the macro-Line angled handpiece GB121R to the motor unit

Hot macro-Line angled handpiece

Gearing worn

Have repaired by manufacturer

Inadequate power at the macro-Line angled handpiece

Intense/loud running noise

Gearing worn

Have repaired by manufacturer

Insufficient power

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 gearings

Have repaired by manufacturer

■ Chapter Manual cleaning and wipe disinfecting

■ Drying phase: Use a lint-free cloth or compressed 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.)

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-

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

Tool not moving

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

-

► For service and repairs, please contact your national B. Braun/Aesculapp agency.

V

Drying

RT

-

-

-

-

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses.

D–W: FD–W: RT:

9.

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

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

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

GA059

STERILIT Power Systems drip lubricator

GB020R

Hexagon wrench

11.

Technical data

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

Designation

Class

GB121R

angled handpiece with Harris adapter

IIa

Designation

Value

Weight

approx. 970 g

Maximum Motor drive rpm

20 000 1/min

Gear ratio

135:1

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. TA-Nr. 005342

01/14

V6

Änd.-Nr. 48673