Hi-Line – Craniotome handpiece GB520R with dura protectorGB536R GB537R GB538R GB547R

1.

Applicable to

4.

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

compatibility, see also www.extranet.bbraun.com

2.

the

Aesculap

Extranet

at

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.

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.

4.1

First use

WARNING

WARNING

WARNING

3.

Product description

3.1

Components required for operation

Designation

Art. no.

Motor (drive)

GA520R, GA519, GD676, etc.

Craniotome (body)

GB520R

Tool (craniotome reamer)

GD804R, GD805R, etc.

Dura protector

GB536R, GB537R, etc.

3.2

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.

Intended use

The Hi-Line craniotome handpiece GB520R with dura protector GB536R/ GB537R/GB538R and GB547R is used in neurosurgical procedures to cut out larger bone plates from the cranium.

3.3

Operating principle

The craniotome takes up the rotational speed of the motor and transfers the rotation to the coupled tool at a transmission ratio of 1:1. The dura protector serves to cover the tool.

3

Aesculap® Hi-Line Craniotome handpiece GB520R with dura protector GB536R/GB537R/GB538R/ GB547R

5.

Working with the craniotome handpiece with dura protector

5.1.3

Uncoupling the tool

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

the motor cannot start up inadvertently. ► Grasp the tool.

5.1

System set-up

► Pull back slide 13 at the handpiece. ► Remove the tool from the craniotome.

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.

WARNING

Risk of infection and contamination! The craniotome and the dura protector are supplied in an unsterile condition. ► Carry out sterile processing of the craniotome and the dura protector prior to first operation.

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.

5.1.4

Mounting the dura protector on the craniotome

► Turn swivel ring 21 of dura protector 20 in the direction of the arrow

in symbol

pins 15 on the craniotome slide into the holes 22 of the dura protector. ► Push dura protector 20 against the craniotome as far as it will go (six possible positions). ► Turn swivel ring 21 in the direction of the arrow in symbol as far as it will go. ► Make certain to leave a small gap between the foot and the craniotome reamer 30 so that the reamer does not grind against the dura protector. The dura protector is mounted now. 5.1.5

Demounting the dura protector from the craniotome

► Turn swivel ring 21 of dura protector 20 in the direction of the arrow

in symbol 5.1.1

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. 5.1.2

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 to 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. ► Completely pull back slide 13 and push the tool into the craniotome handpiece down to the stop. ► Release slide 13. The tool must remain fixed in position even when pulled. 4

as far as it will go.

► Attach dura protector 20 to the craniotome in such a way that the

as far as it will go.

► Detach the dura protector from the craniotome.

5.1.6

Connecting the craniotome to the motor

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

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

in symbol

as far as it will go.

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

the motor engage in the notches 12 on the craniotome 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. 5.1.7

Disconnecting the handpiece from the motor

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

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

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

as

5.2

Function checks WARNING

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.

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. ► Make certain that the craniotome and the dura protector are in a

proper condition. ► Ensure that the bridge at the dura protector guard is straight and does not touch the tool. ► Make certain that tool tip C is in position between stop face A and surface B of dura protector foot 23. ► Make certain that tool tip C does not touch surface B of dura protector foot 23. ► Check for damage to, and irregular running noises, excessive vibrations and excessive heat-up of, the craniotome and the dura protector. ► Check that the handpiece is only warm to the touch after a short period of use, no hotter. ► Check all cutting edges for any mechanical damage.

5.3

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.

CAUTION

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

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

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 caused by hot cutting edges! ► Tools must be continuously cooled during operation. ► Only use sharp tools.

WARNING

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.

5

Aesculap® Hi-Line Craniotome handpiece GB520R with dura protector GB536R/GB537R/GB538R/ GB547R

6. 6.1

Validated reprocessing procedure 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

Products supplied in a sterile/unsterile condition

Reusable products supplied in sterile condition Designation

Art. no.

Craniotome reamer

GD804R–GD806R

► 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 Designation

Art. no.

Craniotome handpiece

GB520R

Dura protector

GB536R–GB538R

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

6

6.3

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.

6.4

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

Cleaning/disinfection

6.6.1

Product-specific safety instructions for the reprocessing procedure

DANGER

CAUTION

CAUTION

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. 7

Aesculap® Hi-Line Craniotome handpiece GB520R with dura protector GB536R/GB537R/GB538R/ GB547R

6.6.2

Validated cleaning and disinfection procedure

Validated procedure

Special features

Manual cleaning and wipe disinfection

■ When cleaning instruments with movable hinges, ensure that these

■ For handpiece/ attachment

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

■ For tools Mechanical alkaline cleaning and thermal disinfecting

8

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.

6.7.1

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

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 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.

9

Aesculap® Hi-Line Craniotome handpiece GB520R with dura protector GB536R/GB537R/GB538R/ GB547R

6.7.2

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. 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.

10

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. 6.8.1

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.

11

Aesculap® Hi-Line Craniotome handpiece GB520R with dura protector GB536R/GB537R/GB538R/ GB547R

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

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

a dry, dark, temperature-controlled area.

► 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.

12

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 craniotome reamers.

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

Craniotome cannot be coupled to the motor

Check position of threaded ring 11 Threaded ring not in ”unlocked” position

Remedy Turn threaded ring 11 in the direction of the arrow in symbol

as far as it will go

Tool cannot be coupled in the craniotome

Tool shaft bent

–

Use a new tool

Tool coupling in handpiece defective

–

Have handpiece repaired by manufacturer

Dura protector cannot be fastened on the craniotome

The foot of the dura protector touches the tool and prevents the holes 2 from engaging on pins 15.

Dura protector too short

Number of rings on the tool must match number of rings on the dura protector

No progress at the skull cap even with the system working without any problem

Wide gap between dura protector foot 23 and tool

Dura protector too long

Poor progress in the cutting slit

Check the tool

Tool very dirty or blunt

Clean tool or use new tool

-

Cutting radius too small

Cut at a larger radius

-

Craniotome badly canted in the cut- If possible, always work at the ting slit same cutter angle

Gap between dura protector foot 23 and tool

Dura protector foot 23 bent

Craniotome not running

Excessive running noise

Use new dura protector 20

Motor runs with handpiece decou- Craniotome jammed pled

Have product repaired by the manufacturer

-

Motor safety stop in ”0” position

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

Loud running noise during normal operation

Worn bearing

Have product repaired by the manufacturer

13

Aesculap® Hi-Line Craniotome handpiece GB520R with dura protector GB536R/GB537R/GB538R/ GB547R

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] 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.

14

10. Accessories/Spare parts Art. no.

Designation

GB600

Aesculap STERILIT oil spray

GB600820

Oil spray adapter

GD804R, GD805R, GD806R

Craniotome reamer

GB536R short (10 mm)

Dura protector, fixed

GB537R medium (15 mm) GB538R long (25 mm) GB547R medium (15 mm)

Dura protector, pivotable

GB563R

Tools

GB562R

Craniotome

GB565R

Dura protector

JF213R (64 mm), JF212R (44 mm)

Tray

JK431

Container

GB473

Eccos storage mounting set

Storage

11. Technical data GB520R

GB536R

GB537R

GB538R

GB547R

Weight

65 g

10 g

13 g

15 g

15 g

Dimensions (∅)

20 mm x 85 mm

15 mm x 40 mm

15 mm x 45 mm

15 mm x 55 mm

15 mm x 45 mm

Craniotome reamer

–

GD804R

GD805R

GD806R

GD805R

Number of rings

–

1

2

3

2

11.1 Ambient conditions Operation

Storage and transport

Temperature

Relative humidity

Atmospheric pressure

12. Disposal Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. ► Detailed information concerning the disposal of the product is 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

15

- 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. 009531 Änd.-Nr. 46258

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