Hi-Line XS handpiece

Aesculap® Hi-Line XS handpiece Legend 1 Sheath 2 Handpiece 3 Slide 4 Threaded ring 5 Handpiece coupling 6 HiLAN XS motor 7 Safety stop 8 Tool 9 Tool coupling 10 Spray nozzle 11 Tube olive 12 Rinsing tube

Symbols on product and packages Rotate “right” (clockwise) to unlock the handpiece

Rotate “left” (counterclockwise) to lock the handpiece

Short handpiece or tool (one ring) Medium handpiece or tool (two rings)

Long handpiece or tool (three rings)

Short XL handpiece or tool (one wide ring)

Medium XL handpiece or tool (two wide rings)

Long XL handpiece or tool (three wide rings)

Reference to the next due maintenance appointment (date) with the international B. Braun/Aesculap agency, see Technical Service

e.g. 2011-02

1.

2.

Product description

2.1

Components required for operation

Art. no.

Designation

e.g. GA740R, GA741R, GA519 e.g. GD670, GD675

HiLAN XS motor microspeed uni

GB751R, GB752R, GB753R

Handpieces, straight

GB756R, GB757R, GB758R

Handpieces, angled

GB771R, GB772R, GB773R

Handpieces, angled, XL

GE401R/SU to GE437R/SU, GE456SU to GE475SU GE501R/SU to GE574R/SU GE603R/SU to GE658R/SU GE700SU to GE729R/SU GE280SU to GE288SU GE290SU to GE298SU

Tools for: GB751R, GB756R GB752R, GB757R GB753R, GB758R GB771R GB772R GB773R

GB761SU to GB766SU

Spray nozzles

2.2

2.3

Operating principle

The handpieces take up the rotational speed of the motor and transfer the motor rotation to the tool held by the handpiece, at a transmission ratio of 1:1. The handpieces can be coupled to the motor in 15 different positions. The tools (e.g. GE401R/SU to GE655R/SU) and the XL tools (e.g. GE280SU to GE298SU and GE700R/SU to GE729R/ SU) are used to work on bones. The cutting wheels (GE430SU, GE530SU) and routers (GE528SU, GE628SU) are used to work on metal (implants, bone screws, etc.) and bones.

3.

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.

3.1

First use Risk of injury and/or product malfunction due to incorrect operation of the pneumatic medical system! ► Adhere to the instructions for use of any medical device. WARNING

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. ► Only combine handpieces and tools with matching ring markings.

Intended use

The straight handpieces GB751R to GB753R and the angled handpieces GB756R to GB758R, GB771R to GB773R are used in micro-, neuro-, spinal, ENT, maxillary and orthopedic surgery.

► Prior to using the handpieces and their accessories, check for visible damage. ► Only use handpieces and accessories if they are in perfect condition.

4.

Working with the handpieces

4.1

System set-up 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. WARNING

Single-use product

WARNING

Risk of infection and contamination! The handpieces are supplied in unsterile condition! ► Prepare handpieces sterile before putting them into operation.

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 products GE280SU to GE298SU, GE401SU to GE729SU and GB761SU to GB766SU are sterilized by radiation and are supplied in sterile packaging. The product must not be reused. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not re-sterilize the product. ► Do not use the product after its use-by date.

WARNING 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. WARNING

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.

4.2

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.

► To prevent cutting through the glove, be careful when touching the tool where it is sharp. ► Insert tool 8 into the tool coupling 9 on the handpiece 2 until the pressure point. Do not use tools that get

jammed or are difficult to insert. ► Insert tool 8 into the handpiece 2 as far as it will go, until the correct position is found.

The labeling of the rings on the tool must be covered by the handpiece shaft. The tool is locked automatically. ► If the pressure point cannot be passed with the tool: Completely pull back slide 3 against the spring pressure and push the tool into the handpiece 2 down to the stop. ► Release slide 3. The tool must remain fixed in position even when pulled.

4.3

Uncoupling the tool

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.

► Hold tool 8. ► Pull back slide 3 at handpiece 2. ► Remove tool 8 from the handpiece.

4.4

WARNING

Connecting a handpiece to the motor

► Turn safety stop 7 on motor 6 to the “0”-position. ► Turn threaded ring 4 of handpiece 2 in the direction of the arrow in symbol as far as it will go. ► Install handpiece 2 on the handpiece coupling 5 of the motor 6 in such a way that the pin on the handpiece

WARNING

engages in one of the notches of the handpiece coupling. ► Turn threaded ring 4 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

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.

vibrations during operation. The handpiece is connected now.

4.5

4.6

WARNING

Disconnecting a handpiece from the motor

► Turn safety stop 7 on motor 6 to the “0”-position. ► Turn threaded ring 4 in the direction of the arrow in symbol ► Detach handpiece 2 from the motor.

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.

as far as it will go.

WARNING

Connecting/Disconnecting the spray nozzle Risk of spray nozzle breakage caused by excessive or frequent bending! ► Handle the spray nozzle with appropriate care. WARNING

WARNING

Note A spray nozzle can be attached to the handpieces for the purpose of cooling the tools and, especially, to avoid heat necroses. If the connection of the spray nozzle at handpiece shaft is unstable, vibrations can cause the tip of the spray nozzle to touch the rotating tool, leading to metal chipping.

Assignment of spray nozzles Handpieces (art. no.)

Rings

Spray nozzles (art. no.)

GB751R, GB756R

I

GB761SU

GB752R, GB757R

II

GB762SU

GB753R, GB758R

III

GB763SU

GB771R

XLI

GB772R GB773R

Damage to micro instruments caused by incorrect handling! ► Protect products against overstraining. ► Do not bend the handpiece shaft. CAUTION 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 maximum motor speed whenever possible. ► Remove any surface contamination with a moistened, disposable wipe/paper tissue immediately after use.

Validated reprocessing procedure

GB764SU

5.1

General safety instructions

XLII

GB765SU

XLIII

GB766SU

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

► From the front, push spray nozzle10 onto sheath1 of the handpiece. ► Fasten irrigation tube 12 onto tube connector 11. To do this, hold spray nozzle10 at tube olive 11. ► If necessary, align the tip of spray nozzle towards the tool. ► Set the irrigation flow at the control unit, as described in the instructions for use of HiLAN irrigation pump GA530

or microspeed uni control unit with cooling unit GD670.

Disconnecting the spray nozzle ► Pull off irrigation tube12 from tube olive11. ► Remove spray nozzle 10 from shaft 1.

Function checks

► Always perform a trial run prior to using the system. ► Make certain the handpieces and tools are in proper condition. ► Make certain the handpiece is coupled correctly. ► Make certain the tool is coupled correctly. ► Watch out for damage, irregular running noises, excessive vibrations and excessive heat developed by the hand-

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.

5.2

Single-use products

piece. ► Verify that the handpiece is no hotter than lukewarm after a short period of use.

4.8

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 Risk of burns and necroses from hot cutting edges of the tool! ► Tools must be continuously cooled during operation. ► Only use sharp tools. WARNING

Risk of tissue injuries/necrosis when cutting through metals (e.g. implants) using the cutting wheel or the routers! ► Cover the operating area. ► Carefully remove metal shavings from the operating site. ► Make certain that the implant is properly cooled.

5.

Connecting the spray nozzle

4.7

Risk of injury from uncoupled tools! Risk of burns from a hot fixation screw! Damage to the fixation screw resulting in loss of functionality due to moving the slide during operation! ► Never move the slide on the handpiece while the system is operating.

Risk of infection 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!

Art. no.

Designation

GE401SU to GE655SU GE280SU to GE298SU GE700SU to GE729SU

Tools

GB761SU to GB766SU

Spray nozzles

5.3

Reusable products

Validated cleaning and disinfection procedure

Reprocessing limit Reusable products supplied in sterile condition Art. no.

Designation

GE401R to GE655R GE702R to GE729R

Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with movable hinges,

Chapter Manual cleaning/ disinfecting and subsection:

■ Handpiece

Tools

ing and 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.)

Reusable products supplied in an unsterile condition Art. no.

Designation

GB751R, GB752R, GB753R

Handpieces, straight

Manual cleaning with ultrasound and immersion disinfection

GB756R, GB757R, GB758R

Handpieces, angled

■ Tools

GB771R, GB772R, GB773R

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.

Preparations at the place of use

■ Cleaning brush ■ When cleaning products with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

Chapter Manual cleaning/ disinfecting and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

■ Drying phase: Use a lint-free cloth or com-

Handpieces, angled, XL

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

5.5

■ Chapter Manual clean-

■ Drying phase: Use a lint-free cloth or com-

► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date.

5.4

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

pressed air for medical purposes Mechanical alkaline cleaning and thermal disinfecting

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

■ When using the rinsing device (GB694R), couple the handpiece onto the rinsing device and connect the rinsing device using the silicone tube with the rinsing connector of the rinsing cart (cleaning and disinfection device).

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ The products may only be cleaned mechanically with an appropriate Eccos holder or rinsing device.

5.8

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.

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

-

-

-

-

► 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.

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

5.6

IV

Final rinse

RT (cold)

0.5

-

FD-W

-

V

Drying

RT

-

-

-

-

Preparation before cleaning

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

5.7

Cleaning/disinfection

D–W: FD–W:

Product-specific safety instructions for the reprocessing procedure RT: Fire hazard! ► Do not use flammable or explosive cleaning or disinfecting solutions. ► Ensure that no fluids will penetrate the product. DANGER 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

CAUTION

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.

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, ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 55 °C.

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.

Manual cleaning with ultrasound and immersion disinfection ► 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.

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

-

-

-

-

► 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.

D–W: FD–W:

Drinking water 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 dis-

infection 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.

5.13 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.

Sterilization method

Temp.

Time

Minimum drying time

Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully.

Prevacuum

270 °F/275 °F

4 min

20 min

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 running 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.

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

*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.

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

6.

Risk of burns, necroses and reduced functionality of the tools due to hot blades! ► Do not re-sharpen or manipulate the tools.

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

5.9

Mechanical cleaning/disinfecting

Maintenance

WARNING To ensure reliable operation, the product must be maintained as indicated on the maintenance label.

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.

e.g. 2011-02 For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

7.

Mechanical alkaline cleaning and thermal disinfecting

Troubleshooting list

Machine type: single-chamber cleaning/disinfection device without ultrasound

Malfunction

Detection

Cause

Remedy

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

Handpiece cannot be coupled to the motor

–

Threaded ring not in ”unlocked” position

Turn the threaded ring in the direction of the arrow in sym-

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

bol Tool cannot be coupled to the handpiece

–

Tool shaft bent

Use a new tool

–

Handpiece sheath bent

Have product repaired by the manufacturer

Pressure point cannot be passed

Automatic locking mechanism defective

Couple the tool with the slide actuated

Tool can not be uncoupled even with the slide fully actuated

Fixation screw worn

Have product repaired by the manufacturer

Locking ring/clip in locked position

Slide locked

Rotate the locking ring/locking clip by 180° to unlock the slide

Motor runs with handpiece decoupled

Handpiece blocked

Have product repaired by the manufacturer

Motor safety stop in ”0” position

Motor locked

Turn the safety stop on the motor to the ”I” position

Loud running noise

Loud running noise during normal operation

Worn gear or bearing

Have product repaired by the manufacturer

Handpiece heats up too much

Significant heat-up after short period of operation

Worn gear or bearing

Have product repaired by the manufacturer

– 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

Tool cannot be uncoupled

Handpiece not running

D–W: FD–W:

Drinking water 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/disinfecting.

5.10 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. ► Hi-Line XS handpiece must be sprayed through with Aesculap-STERILIT oil spray GB600 with adapter GB600820

until clear oil emerges from the product.

8.

Technical Service

► 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.

5.11 Packaging ► Always follow the instructions for use of the respective packaging and storage devices (e.g. instructions for use

TA009721 for the 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.

5.12 Steam sterilization Note The handpieces must be steam sterilized due to the limited tolerance to high temperature of the materials in them. Do not sterilize the handpieces with hot air or ethylene oxide (EtO). The handpieces and tools (GE401R to GE729R) 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 – 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.

as far as it will go

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

9.

Accessories/Spare parts

Art. no.

Designation

GB600

Aesculap maintenance oil

GB600820

STERILIT-Power Systems adapter

GB473

Eccos storage mounting set

GB613R

Eccos storage aid for tools

GB614R/GB611R

Eccos storage aid for handpieces

GB694R

Rinsing device

GB761SU

Spray nozzles (for single use):

1 ring

GB762SU

2 rings

GB763SU

3 rings

GB764SU

XLI, 1 ring

GB765SU

XLI, 2 rings

GB766SU

XLI, 3 rings

GE401R to GE655R

Tools:

reusable

GE401SU to GE658SU GE702R to GE729R

single use XL tools:

reusable

GE280SU to GE298SU GE700SU to GE729SU

single use

GB770

Locking clip

JF223R, JF222R

Tray

JK400, JK401

Container

10.

Technical data

Handpiece

Weight

Marking

Length of shaft

Dimension x Length (mm)

GB751R S74932

30 g

1 ring

38 mm

∅ 17.5 x 91.5

GB752R S74933

35 g

2 rings

68 mm

∅ 17.5 x 121.5

GB753R S74934

40 g

3 rings

98 mm

∅ 17.5 x 151.5

GB756R

35 g

1 ring

38 mm

∅ 17.5 x 108.5

GB757R

40 g

2 rings

68 mm

∅ 17.5 x 138.5

GB758R

45 g

3 rings

98 mm

∅ 17.5 x 168.5

GB771R

54 g

1 ring

128 mm

∅ 17.5 x 198.5

GB772R

58 g

2 rings

158 mm

∅ 17.5 x 228.5

GB773R

68 g

3 rings

218 mm

∅ 17.5 x 288.5

11.

Disposal

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

agency, see Technical Service.

12.

Distributor in the US/Contact in Canada for product information and complaints

Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 011267

11/12

V6

Änd.-Nr. 46302