HiLine handpieces

1.

Applicable to

3.

Product description

3.1

Components required for operation

► For item-specific instructions for use and information on material

compatibility, see also www.extranet.bbraun.com

the

Aesculap

Extranet

at

Art. no.

Designation

GA519, GA520R, GA529, GD676, ... Motor (drive)

2.

Safe handling

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. ► Always adhere to applicable standards. Single-use product

WARNING

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product.

GB530R, GB531R, ...

Handpiece (body)

GD720R, ...

Tool

GB550SU, ...

Spray nozzle (optional)

3.2

Intended use

The HiLine straight handpieces GB529R, GB530R, GB531R, and GB532R, and angled handpieces GB519R, GB533R, GB534R, and GB535R are used in microsurgery, ENT surgery, neurosurgery, and spinal surgery, as well as for cement removal in hip endoprosthetic revision procedures, and in maxillary surgery. The tools (e.g., GD691R–GD848R) are used to prepare the bones. The cutting disks (GD763R or GD840R) are used to machine metal (implants, bone screws, etc.) and bones.

3.3

Operating principle

The HiLine handpiece takes up the rotational speed of the motor and transfers the rotation to the coupled tool at a transmission ratio of 1:1.

3

Aesculap® HiLine HiLine handpieces

4.

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► When setting up and operating the product, adhere to – national regulations for installation and operation, – national regulations on fire and explosion protection.

5.

Working with the HiLine handpiece

5.1

System set-up

WARNING

4.1

First use

WARNING

WARNING

WARNING

4

Risk of injury and/or product malfunction due to incorrect operation of the electromedical system! ► Adhere to the instructions for use of any medical device. Risk of injury and material damage due to inadvertent activation of the motor! ► Make certain that the motor cannot be activated inadvertently during tool change. ► Change tools only with the motor secured by the safety stop. Risk of burns and other injuries due to bent or incorrectly coupled tools! ► Make certain that the tool is coupled correctly. ► Only use perfectly straight tools.

WARNING

WARNING

Risk of injury and material damage due to inadvertent activation of the motor! ► Turn the safety stop on the motor to the “0” position. ► Change tools only with the motor secured by the safety stop. Risk of infection and contamination! HiLine handpieces are supplied in an unsterile condition. ► Carry out sterile processing of the HiLine handpiece prior to first use. Risk of injury from bent or snapped tools! ► Only use handpieces and tools marked with the same number of rings. ► Do not use tools on which the ring markings are not visible anymore.

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.

5.2

Coupling a tool

WARNING

Risk of burns and other injuries due to bent or incorrectly coupled tools! ► Only use perfectly straight tools. ► Make certain that the tool is coupled correctly. ► Do not use tools on which the ring markings are not visible anymore.

► Move safety stop 3 on motor 1 to the "0" position and make certain

that the motor cannot start up inadvertently. ► To prevent cutting through the glove, be careful when touching the

tool where it is sharp. ► Insert the tool down to the pressure point in tool coupling 14 of the

handpiece. Do not use tools that get jammed or are difficult to insert.

5.4

Connecting a handpiece to the motor

► Move safety stop 3 on motor 1 to the "0" position and make certain

that the motor cannot start up inadvertently. ► Turn threaded ring 11 of handpiece 10 in the direction of the arrow in

symbol

as far as it will go.

► Attach handpiece 10 to the motor in such a way that the nibs 2 on the

motor engage in the notches 12 on handpiece 10 (four possible positions). ► Turn threaded ring 11 in the direction of the arrow in symbol as far as it will go. ► Make certain that the threaded ring is fastened to its limit stop, because otherwise it may come loose due to vibrations during operation. The handpiece is connected now.

► Push the tool into the handpiece down to the stop, until it finds its cor-

rect position (the ring markings on the tool must be invisible inside the handpiece shaft). The tool is locked automatically. If the pressure point cannot be passed with the tool: ► Completely pull back slide 13 and push the tool into the handpiece down to the stop. ► Release slide 13. The tool must remain fixed in position even when pulled.

5.5

► Move safety stop 3 on motor 1 to the "0" position and make certain

that the motor cannot start up inadvertently. ► Turn threaded ring 11 in the direction of the arrow in symbol

Uncoupling a tool

► Move safety stop 3 on motor 1 to the "0" position and make certain

that the motor cannot start up inadvertently. ► Grasp the tool. ► Pull back slide 13 at the handpiece. ► Remove the tool from the handpiece.

as

far as it will go. ► Detach handpiece 10 from motor 1.

5.6 5.3

Disconnecting a handpiece from the motor

Spray nozzles

Spray nozzles can be installed on the handpieces for operating the motor system with an additional automatic irrigation unit. ► From the front, push spray nozzle 20 onto shaft 15 of the handpiece. Fasten irrigation tube 22 onto tube connector 21. Align the spray nozzle on the tool if necessary. ► Set the irrigation flow on the device (see also the instructions for use of the HiLAN irrigation pump and the Micro-Speed uni control unit). ► Use spray nozzles of the correct length for the respective handpieces: Spray nozzle

For handpiece

GB549R

GB519R, GB529R

GB550SU

GB530R, GB533R

GB551SU

GB531R, GB534R

GB552SU

GB532R, GB535R

► Remove the spray nozzle from the handpiece after the operation and

before the reprocessing procedure.

5

Aesculap® HiLine HiLine handpieces

5.7

Using tools with a long protrusion

Some tools with a longer protrusion can be used for operating in very tight approaches. These tools are identified by special markings. The marking consists of two sets of symbols (e.g., one ring and triangles, two rings and one ring). With the first marking, these tools can be used as standard tools; with the second marking they can be used with a long protrusion. ► Use tools marked with dots and two rings as tools with a long protrusion only in combination with the two-ring handpieces. Tools used in the shorter handpieces (long tool protrusion) may be used only once. Risk of bending during reprocessing! ► Only use perfectly straight tools. WARNING Handpiece

Marking (handpiece)

Standard tools, also suitable for use with a long protrusion

Marking (tools) First

Second

GB519R, GB529R

Triangles

GD691R, GD694R, GD732R, GD735R, GD738R, GD807R, GD786R, GD789R, GD792R, GD795R

1 ring

Triangles

GB530R, GB533R

1 ring

GD692R, GD695R, GD733R, GD736R, GD739R, GD808R, GD742R, GD751R, GD754R, GD757R, GD787R, GD790R, GD793R, GD796R, GD799R

2 rings

1 ring

Handpiece

Marking (handpiece)

Tools, only suitable for use with a long protrusion

Marking (tools)

GB531R, GB534R

2 rings

GD697R, GD698R, GD699R, GD700R, GD701R, GD707R, GD708R, GD709R, GD710R, GD711R

Note Use tools with a long protrusion only when actually necessary! Protect the tool with a protective sleeve! Protective sleeves to install on the handpiece shaft: Protective sleeve

Handpiece

GB524R

GB519R, GB529R

GB525R

GB530R, GB533R

GB526R

GB531R, GB534R

► Detach the protective sleeve from the handpiece prior to reprocessing

and sterilization (observe the instructions for use of the protective sleeve, TA011126).

6

5.8

First

Second

Dots

2 rings

Reamer guard GB527R

Reamer guard GB527R can be used for working in particularly delicate operating areas. Note Use Rosen burrs and diamond tools with head diameters of up to 4.5 mm (observe the instructions for use of the reamer guard, TA010733). ► Use the reamer guard to cover the tool head laterally. ► Push the reamer guard onto the front end of the handpiece shaft. ► Check that the reamer guard is firmly seated on the handpiece shaft. ► Secure the irrigation tube to the tube connector.

5.9

Function checks WARNING

Risk 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.

WARNING

Risk of injury and damage to the tool/system! The rotating tool may catch cover drapes (textile or other). ► Never allow the tool to touch cover drapes (textile or other) during operation.

► Check the system by a trial run prior to each application. ► Check that the handpiece is in a proper working condition. ► Watch out for damage, atypical running noises, excessive vibrations,

and excessive heat-up of the handpiece. ► Check that the handpiece is only warm to touch after a short period of

use, no hotter. ► Check all cutting edges for any mechanical damage.

5.10 Safe operation

WARNING

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

WARNING

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

WARNING

Risk of injury from bent or snapped tools! ► Only use perfectly straight tools. ► Only apply mild pressure when using a tool.

WARNING

Eye injuries caused by particles coming loose from the tool! ► Always wear protective goggles when using the motor system.

WARNING

CAUTION

Risk of tissue trauma/necrosis when cutting through metals (e.g., implants) with the cutting disk! ► Cover the operating area. ► Carefully remove metal shavings from the operating site. ► Make certain that the implant is properly cooled. Damage to micro instruments caused by incorrect handling! ► Protect products against overstraining. ► Do not bend the handpiece shaft.

Note Do not run the handpiece without a tool coupled for any length of time! ► To fully exploit the advantages of this power system, operate it at max-

WARNING

WARNING

WARNING

Risk of burns and necroses caused by hot cutting edges! ► Tools must be continuously cooled during operation. ► Only use sharp tools.

imum motor speed whenever possible. Advice: ► Remove any surface contamination with a moistened, disposable wipe/ paper tissue immediately after use.

Coagulation of patient’s tissue caused by a hot handpiece! ► Allow the handpiece to cool down. ► Do not use a handpiece whose bearings are damaged. ► Tools must be continuously cooled during operation. Risk of injury from an uncoupled tool, risk of burns from the hot fixation screw and damage to the fixation screw resulting in loss of functionality due to moving of the slide during operation! ► Never move the slide on the handpiece while the system is operating.

7

Aesculap® HiLine HiLine handpieces

6.

Validated reprocessing procedure

6.1

General safety instructions

6.3

Reusable products

Reprocessing limit Reusable products supplied in sterile condition

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

Single-use products

WARNING

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product!

The following products must not be reprocessed: Art. no.

Designation

GB550SU, GB551SU, GB552SU

Spray nozzle

8

Art. no.

Designation

GD691R–GD848R

Tools

► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date. Reusable products supplied in an unsterile condition

Art. no.

Designation

GB529R, GB530R, GB531R, GB532R

Handpiece, straight

GB519R, GB533R, GB534R, GB535R

Handpiece, angled

GB527

Reamer guard

GB524R, GB525R, GB526R

Protective sleeve

GB549R

Spray nozzle

► Carry out sterile processing of the product prior to first use.

6.4

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 precleaning 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.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

6.5

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.

6.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

DANGER

CAUTION

CAUTION

Risk of electric shock and fire hazard! ► Do not use flammable or explosive cleaning or disinfecting solutions. ► Ensure that no fluids will penetrate the product. 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. Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents approved for plastics and high-grade steel according to manufacturer’s instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 55 °C.

► 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. ► Carry out ultrasound cleaning: – as an effective mechanical supplement to manual cleaning/disinfection. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfection. – as an integrated mechanical support measure for mechanical cleaning/disinfection. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting.

9

Aesculap® HiLine HiLine handpieces

Validated cleaning and disinfection procedure Validated procedure

Special features

Manual cleaning and wipe disinfection

■ When cleaning instruments with movable hinges, ensure that these

■ Handpiece

Reference

Chapter Manual cleaning/disinfecting and subare in an open position and, if applicable, move the joint while clean- section: ing. ■ 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.) Manual cleaning with ultrasound and immersion disinfection

■ Tools Mechanical alkaline cleaning and thermal disinfecting

10

Chapter Manual cleaning/disinfecting and sub■ Cleaning brush section: ■ Drying phase: Use a lint-free cloth or compressed air for medical pur■ Chapter Manual cleaning with ultrasound poses and immersion disinfection

■ Insert the product in its proper position in the Eccos holder. ■ The products may only be cleaned mechanically with an appropriate Eccos holder.

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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 disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for

residues. ► Repeat the cleaning/disinfection process if necessary.

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

-

V

Drying

RT

-

-

-

-

D–W: FD–W: RT:

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

Phase I

Phase III

► Clean the product under running faucet water, using a suitable clean-

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

ing 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 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.

11

Aesculap® HiLine HiLine handpieces

Manual cleaning with ultrasound and immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for

at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully.

12

Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing. ► Rinse lumens at least five times at the beginning of the exposure time

with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during

final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► 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

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.

Mechanical alkaline cleaning and thermal disinfecting 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: – 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

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

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing.

13

Aesculap® HiLine HiLine handpieces

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 HiLine motor/handpiece with Aesculap-STERILIT oil spray GB600 with adapter GB600820 until clear oil emerges from the product. ► 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.

6.10 Packaging

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. 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

► 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.

*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 6.11 Steam sterilization Note The handpieces are designed for steam sterilization (limited tolerance to high temperatures of the handpiece materials). Do not sterilize the handpieces with hot air or ethylene oxide (EtO). The handpieces and tools (GD691R–GD848R) can be sterilized in their storage units. ► 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 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.

14

► Store sterile products in germ-proof packaging, protected from dust, in

a dry, dark, temperature-controlled area.

7.

Maintenance

WARNING

Risk of burns, necroses and impaired functioning of the craniotome reamer caused by hot blades! ► Do not re-sharpen or manipulate the tools.

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

Handpiece cannot be coupled to the motor

Threaded ring not in ”unlocked” position

-

Turn threaded ring 11 in the direction of the arrow in symbol as far as it will go

Tool cannot be coupled to the handpiece

Tool shaft bent

Visible flexion

Use a new tool

Handpiece not running

Handpiece blocked

Motor runs with handpiece decoupled

Repair by manufacturer

Motor safety stop in ”0” position

-

Turn the safety stop on the motor to “1”

Excessive running noise

Worn gear or bearing

Loud running noise during normal operation

Repair by manufacturer

Handpiece heats up too much

Worn bearing or gear

Significant heat-up after short period of operation

Repair by manufacturer

Operational heat-up

Handpiece was operated in contin- Allow handpiece to cool down; uous use for more than 10 minutes after that the handpiece will be approx. ready for use again

Spray nozzle/protective sleeve can- Damaged mounting of spray noznot be installed on the handpiece zle/protective sleeve

Mounting too wide/narrow

Use a new spray nozzle/protective sleeve

No fluid emerging at the front of the spray nozzle/protective sleeve

Irrigation pump not switched on

Pump not delivering

Switch on irrigation pump

Pump not closed

Pump not delivering

Push pump lever down

Reservoir bag/bottle empty

-

Connect a full bag/bottle

Irrigation tube not coupled

-

Connecting the irrigation tube

Irrigation pipe clogged

Irrigation pipe not patent

Use a new spray nozzle/protective sleeve

15

Aesculap® HiLine HiLine handpieces

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.

10. Accessories/Spare parts Designation

Art. no.

Oil spray

GB600

Spray adapter

GB600820

Tools

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.

16

Standard

e.g.: GD691R-GD696R GD713R-GD809R GD841R-GD848R

Ultra-short

e.g.: GD820R-GD840R

XL

e.g.: GD703R, GD706R GD810R-GD819R

Long protrusion 2 rings

GD697R-GD711R

Spray nozzles (for single use)

GB550SU-GB552SU

Reamer guard

GB527R

Protective sleeve

Short

GB524R

Medium

GB525R

Long

GB526R

Eccos storage mounting set

GB473

Storage

Tools

GB563R

Handpieces

GB562R

XL tools

GB568R

Tray

JF212/JF213

Container

JK431

11. Technical data Handpiece

Weight (g)

Marking

Shaft length (mm)

Dimensions ∅ x L (mm)

GB519R

75

Triangle

25

20.5 x 110

GB529R

65

Triangle

25

20.5 x 93

GB530R

70

1 ring

45

20.5 x 113

GB531R, S74281

75

2 rings

65

20.5 x 133

GB532R, S74282

80

3 rings

105

20.5 x 176

GB533R

75

1 ring

45

20.5 x 130

GB534R, S74283

85

2 rings

65

20.5 x 150

GB535R, S74284

95

3 rings

105

20.5 x 193

GB521R

110

1 ring

170

20.5 x 250

GB522R

130

2 rings

250

20.5 x 300

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 avail-

able 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

17

- DIR 93/42/EEC

Technical alterations reserved

Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com Aesculap – a B. Braun company

TA-Nr. 009532 Änd.-Nr. 46258

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