Craniotome handpiece GB740R and accessories

Aesculap® Hi-Line XS Craniotome handpiece GB740R and accessories Legend 1 Craniotome handpiece GB740R 2 Threaded ring 3 Handpiece coupling 4 HiLAN XS motor 5 Safety stop 6 Tool coupling 7 Slide 8 Dura protector foot 9 Dura protector (fixed) e.g. GB741R,... 10 Swivel ring 11 Handpiece coupling 12 Craniotome reamer 15 Depth stop GB744R 16 Pushbutton 17 Scale 18 Swivel ring 19 Stop sleeve 20 Holding sleeve GB745R 21 Swivel ring 22 Dura protector mount 23 Swivel ring 24 Dura protector (pivoted) e.g. GB746R,... 25 Spray nozzle GB767SU 26 Hose barb 27 Irrigation tube A Stop face of the dura protector foot B Base of the dura protector foot C Front face of the craniotome reamer X Cover Y Gap Z Height of the bone chip

► 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.

3.

Product description

3.1

Components required for operation

Craniotomy Designation

Art. no.

HiLAN XS motor microspeed uni/EC

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

Craniotome handpiece

GB740R

Dura protector (fixed) Dura protector (pivoted)

GB741R, GB742R, GB743R GB746R, GB747R, GB748R

Craniotome reamer

GE420R/SU, GE520R/SU, GE620R/SU GE429SU, GE529SU, GE629SU

Drill holes for osteosynthesis Designation

Art. no.

HiLAN XS motor microspeed uni/EC

e.g. GA740R e.g. GD670

Craniotome handpiece

GB740R

Spiral burr

GE389R/SU, GE390R/SU, GE391R/SU, GE395R/SU

Depth stop

GB744R

Holding sleeve

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

Rotate “right” to unlock the craniotome handpiece/dura protector

Designation

Art. no.

HiLAN XS motor microspeed uni/EC

e.g. GA740R e.g. GD670

Craniotome handpiece

GB740R

Ball reamer "Twin Cut"

GE396R/SU, GE397R/SU

Diamond reamer

GE381R–GE383R, GE386SU, GE387SU, GE394R/SU, GE398R/SU, GE399R/SU

Pin reamer

GE392R/SU

Holding sleeve

GB745R

Rotate “left” to lock the craniotome handpiece/dura protector

I

Short dura protector or craniotome reamer (one ring)

II

medium length dura protector or craniotome milling cutter (two rings)

III

long dura protector or craniotome milling cutter (three rings) Tool markings for holding sleeve and depth stop

3.2

Intended use

3.2.1

Craniotomy

The craniotome handpiece GB740R is used in neurosurgery for cutting out bone flaps from the skull pan. The dura protector, e.g. GB741R, serves to cover the rotating craniotome reamer.

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

Depth stop

The craniotome handpiece GB740R is used in neurosurgery and spinal surgery for preparing drill holes for plating bone screws. Depth stop GB744R is used for setting the drilling depth.

e.g. 2011-02

3.2.3

1.

Applicable to

Holding sleeve

Craniotome handpiece GB740R is used in neurosurgery for surface procedures such as opening the skull pan, or for mastoidectomy in ENT surgery. Holding sleeve GB745R improves the grip on the handpiece.

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

at www.extranet.bbraun.com

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. ► Do not use craniotome reamers that are longer than the craniotome handpiece. ► Only combine craniotome reamers and craniotome handpieces with matching ring markings. 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.

The products GE386SU to GE399SU, GE420SU, GE429SU, GE520SU, GE529SU, GE620SU, GE629SU and GB767SU are radiation sterilized and packaged sterile. The product must not be reused.

3.3

Operating principle

The craniotome handpiece makes the inserted tool rotate at motor speed (transmission ratio 1:1). The craniotome handpiece can be coupled to the HiLAN XS motor in 15 positions. The dura protector (fixed), as well as the depth stop and holding sleeve can be attached to the craniotome handpiece in 8 positions. The dura protector (pivoted) is freely pivotable on the craniotome handpiece.

4.

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

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 craniotome handpiece, the dura protector and the depth stop and holding sleeve for visible damage. ► Only use the craniotome handpiece, its accessories and the dura protector or depth stop and holding sleeve if they are in perfect condition.

5.

Working with the Craniotome handpiece with the dura protector or the depth stop and holding sleeve

5.1

System set-up

WARNING

WARNING

5.1.1

Risk of burns or other injury due to a bent or incorrectly coupled craniotome reamer grinding against the dura protector or the depth stop and holding sleeve! ► Only use perfectly straight and sharp tools. ► Verify that the tool is coupled correctly. ► Do not use tools on which the ring markings are not visible anymore.

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.

for a contact address, see Technical Service. Coupling a tool ► To prevent cutting through the operating glove, be careful when touching the tool in the cutting region. ► Insert tool 12 into the tool coupling 6 on the craniotome handpiece 1 up to the pressure point. Do not use tools that get jammed or are difficult to insert. ► Push the tool into the craniotome handpiece down to the positive stop (the ring or triangle markings on the tool must be fully covered inside the handpiece shaft). The tool is locked automatically. ► If the pressure point cannot be passed with the tool: Pull back slide 7 fully and push the tool as far as it will go into the craniotome handpiece. ► Release slide 7. The tool must remain fixed even when pulled. Uncoupling a tool ► Hold on to tool 12. ► Pull back slide 7 on the craniotome handpiece 1. ► Remove tool 12 from the craniotome handpiece.

Note A spray nozzle can be connected at the dura protector or the holding sleeve for the purpose of cooling the tools and, especially, to avoid necroses. If the connection of the spray nozzle at the dura protector or the holding sleeve is unstable, vibrations can cause the tip of the spray nozzle to touch the rotating tool, leading to metal chipping. Connecting the spray nozzle ► Push spray nozzle 25 via the front-end onto the dura protector foot 8 or the holding sleeve 20. ► Fasten irrigation tube 27 onto the hose barb 26 and hold on to the hose barb 26 when doing so. ► If necessary, align tip of the spray nozzle 25 with 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 ► Detach irrigation tube 27 from the hose barb 26. ► Detach spray nozzle 25 from the dura protector foot 8 or from the holding sleeve 20.

5.2

Function checks

► Verify that the craniotome handpiece, the dura protector/attachment and the tool are in proper condition. ► Ensure that the tool and the dura protector/attachment are coupled correctly. ► Check that the craniotome handpiece with a tool coupled runs quietly and vibration-free. ► Prior to each use, check and ensure that the bridge at the guard bracket of the dura protector is straight; also

ensure that the guard bracket does not touch the craniotome reamer. ► Ensure that the front face of the craniotome reamer C sits between the stop face A and base B of the dura pro-

tector foot 8. Note The front face of the craniotome reamer C must not touch the base B, as this can generate heat and cause metal abrasion, and it must not be positioned above the stop face A, as this would leave a bone chip Z.

5.3

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

Mounting the dura protector or depth stop and holding sleeve on the craniotome handpiece

Mounting the dura protector (fixed) or the depth stop and holding sleeve on the craniotome handpiece ► Turn swivel ring 10/18/21 of the dura protector (fixed) 9 or of the depth stop 15 or of the holding sleeve 20 in the direction of the arrow in symbol as far as it will go. ► Attach the dura protector (fixed) 9 or depth stop 15 or holding sleeve 20 to the craniotome handpiece in such as way that 1 the pin on the dura protector (fixed) or on the attachment is seated in one of the notches on the craniotome handpiece. ► Turn swivel ring 10/18/21 in the direction of the arrow in symbol as far as it will go. ► Ensure that the swivel ring 10/18/21 is tightened to its limit stop, because otherwise it may come loose due to vibrations during operation. The dura protector (fixed)/attachment is locked now. Mounting the dura protector (pivoted) on the craniotome handpiece ► Turn swivel ring 23 of the dura protector (pivoted) 24 in the direction of the arrow in symbol as far as it will go. ► Attach dura protector (pivoted) 24 to the craniotome handpiece 1. ► Turn swivel ring 23 in the direction of the arrow in symbol as far as it will go, and hold on to the dura protector mount 22 when doing so. ► Ensure that the swivel ring 23 is tightened to its limit stop, because otherwise it may come loose due to vibrations during operation. ► Ensure that the dura protector (pivoted) 24 can be turned freely and easily on the craniotome handpiece. The dura protector (pivoted) is locked now. Note The dura protector and craniotome reamer are correctly assembled if a small gap Y is present between the dura protector foot and craniotome reamer.

Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. 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 from bent or snapped craniotome reamers! ► Only use perfectly straight craniotome reamers. ► Only apply mild pressure when using a craniotome reamer. WARNING Eye injury 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 Coagulation of patient’s tissue caused by the hot craniotome handpiece! ► Allow the craniotome handpiece to cool down. ► Do not use a craniotome handpiece whose bearings are damaged.

Uncoupling of the dura protector/attachment

Uncoupling the dura protector (fixed)/attachment ► Turn swivel ring 10/18/21 of the dura protector (fixed) 9 or of the depth stop 15 or of the holding sleeve 20 in the direction of the arrow in symbol as far as it will go. ► Remove the dura protector (fixed) 9 or attachment. Uncoupling the dura protector (pivoted) ► Turn swivel ring 23 of the dura protector (pivoted) 24 in the direction of the arrow in symbol will go, and hold on to the dura protector mount 22 when doing so. ► Remove dura protector (pivoted) 24.

5.1.4

WARNING

holding sleeve mounted.

► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect;

5.1.3

Connecting/Disconnecting the spray nozzle

► Prior to each use, test-run the craniotome handpiece with a tool coupled and a dura protector or depth stop/

Note The tool must be coupled prior to attaching the dura protector and the holding sleeve. For the depth stop, the tool can be coupled before or after mounting the attachment.

5.1.2

WARNING Risk of burns from a hot fixation screw and damage to the fixation screw resulting in loss of functionality due to moving the slide during operation! ► Never move the slide on the craniotome handpiece during operation.

as far as it 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.

Coupling the craniotome handpiece to the HiLAN XS motor

► Turn safety stop 5 on the motor 4 to “0”. ► Turn threaded ring 2 of the craniotome handpiece 1 in the direction of the arrow in symbol

as far as it will

go. ► Install the craniotome handpiece on the motor in such a way that the pin on the craniotome handpiece is seated

in one of the notches in the hand piece coupling of the motor.

as far as it will go.

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

Risk of infection and contamination! The craniotome handpiece and the dura protector/depth stop and holding sleeve are supplied in unsterile condition! ► Carry out sterile processing of the craniotome handpiece and the dura protector/depth stop and holding sleeve prior to putting the products into operation.

Risk of injury from bent or snapped craniotome reamers! ► Only use a dura protector and craniotome reamer marked with the same number of rings. ► Do not use craniotome reamers on which the ring markings have become invisible.

Uncoupling the craniotome handpiece from the HiLAN XS motor

► Turn safety stop 5 on the motor 4 to “0”. ► Turn threaded ring 2 in the direction of the arrow in symbol ► Remove craniotome handpiece 1 from the motor.

5.1.6

Connecting the accessories

WARNING

tions during operation. The craniotome handpiece is locked now.

5.1.5

Risk of injury and material damage due to inadvertent actuation 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

► Turn threaded ring 2 in the direction of the arrow in symbol as far as it will go. ► Make certain the threaded ring is fastened to its limit stop, because otherwise it may come loose due to vibra-

WARNING

WARNING

Risk of injury (necroses) and damage to the craniotome reamer due to contact with the guard bracket (metal abrasion)! ► Work with mild forward pressure only. ► Replace craniotome reamer after any collision.

Note Do not run the handpiece without a tool coupled for any length of time! ► For fully exploiting the advantages of this power system, operate it at maximum motor speed whenever possible. ► Cool craniotome reamer 12 continuously during operation, as the material worked on will heat up due to the

6.3

Reusable products

Reusable products supplied in sterile condition Designation

Art. no.

Craniotome reamer

GE420R, GE520R, GE620R

Spiral burr

GE389R, GE390R, GE391R, GE395R

Ball reamer "Twin Cut"

GE396R, GE397R

Diamond reamer

GE381R–GE383R, GE394R, GE398R, GE399R

Pin reamer

GE392R

high rotation speeds of the tool. ► We recommend removing surface debris immediately after operating the system, using a moistened disposable

cloth or paper tissue.

5.3.1

Operation for craniotomy

► Insert the dura protector (fixed) 9/dura protector (pivoted) 24 into the drill hole and guide the dura protector

foot 8 along the underside of the skull cap (to do this pull out handpiece slightly). ► To prevent the craniotome reamer 12 from bending too much and coming into contact with the guard bracket,

work with mild forward pressure only. ► To prevent the guard bracket from jamming in the reaming slit, hold the craniotome handpiece 1 as vertically as

possible and do not tilt or cant it.

5.3.2

Risk of injury (necroses) and damage to the spiral burr due to contact with the stop sleeve (metal abrasion)! ► Drill axially whenever possible. WARNING The drilling depth does not correspond to the value set on the scale of the depth stop! ► Only use the appropriate spiral burrs. ► Do not repoint the spiral burrs.

► To adjust the drilling depth, press pushbutton 16 and move the stop sleeve 19 into the desired position.

The scale 17 shows the set drilling depth. The drilling depth can be set from 2 mm to 8 mm, in increments of 1 mm.

5.3.3

Reusable products supplied in unsterile condition Designation

Operating the depth stop

CAUTION

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

Operating the holding sleeve

► When working with the holding sleeve, hold the system at the holding sleeve whenever possible. This will

enhance the system precision.

Art. no.

Craniotome handpiece

GB740R

Dura protector (fixed)

GB741R, GB742R, GB743R

Depth stop

GB744R

Holding sleeve

GB745R

Dura protector (pivoted)

GB746R, GB747R, GB748R

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

6.3.1

Reprocessing limit

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

6.4

General information

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.

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.

Note If there is no final sterilization, then a virucidal disinfectant must be used.

6.5

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 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

6.6

Preparation before cleaning

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

Single-use products

WARNING

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.

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!

Designation

Art. no.

Craniotome reamer

GE420SU, GE520SU, GE620SU GE429SU, GE529SU, GE629SU

Spiral burr

GE389SU, GE390SU, GE391SU, GE395SU

Ball reamer "Twin Cut"

GE396SU, GE397SU

Diamond reamer

GE386SU, GE387SU, GE394SU, GE398SU, GE399SU

Pin reamer

GE392SU

Spray nozzle

GB767SU

6.7

Cleaning/disinfection

6.7.1

Product-specific safety instructions for the reprocessing procedure 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

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.

6.7.2

Validated cleaning and disinfection procedure

Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning instruments with mov-

Chapter Manual cleaning/disinfecting and subsection:

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

■ For Handpiece/Attachment

■ Chapter Manual cleaning and wipe disinfecting

■ Drying phase: Use a lint-free cloth or compressed air for medical purposes

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.

■ 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

■ Cleaning brush ■ Drying phase: Use a lint-free cloth or compressed air for medical purposes

■ For tools Mechanical alkaline cleaning and thermal disinfecting

Chapter Manual cleaning/disinfecting and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

■ Insert the product in its proper posi-

Chapter Mechanical cleaning/disinfecting and subsection:

tion in the Eccos holder.

■ Mechanical cleaning of the products is

■ Chapter Mechanical alkaline

only permitted with a corresponding Eccos holder.

6.8

cleaning and thermal disinfecting

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.

6.8.1 Phase

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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

-

-

-

-

RT:

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

Phase I ► Clean the product under running faucet water, using a suitable cleaning brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Phase II ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure. Phase III ► Wipe all surfaces of the product with a single-use disinfectant wipe.

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

6.9

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).

6.9.1

Mechanical alkaline cleaning and thermal disinfecting

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: 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.

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.

6.8.2

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.

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

I

D–W: FD–W:

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.

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

Manual cleaning and wipe disinfecting Step

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.

Manual cleaning with ultrasound and immersion disinfection

6.10 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. ► 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.

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*

6.12 Steam sterilization ► Validated sterilization process

6.11 Packaging

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

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.

► 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.

► 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). – 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.

9.

6.13 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.

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

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

WARNING

Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*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.

6.14 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area. ► Store sterile packed single-use products dust-protected in a dry, dark and temperature-controlled room.

7.

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

Modifications carried out on medical technical equipment may result in loss of warranty rights and 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.

10.

To ensure reliable operation, the product must be maintained as indicated on the maintenance label, see Fig. 1.

Fig. 1 Maintenance label e.g. 2011-02 For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

8.

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

Troubleshooting list

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

Malfunction

Detection

Cause

Remedy

GB611R/GB614R

Eccos storage aid (for craniotome handpiece)

Craniotome handpiece can not be coupled to the motor

Check the position of the threaded ring.

Threaded ring 2 is not in unlocked position

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

GB615R

Eccos storage (for dura protector and depth stop/ holding sleeve)

-

Tool cannot be coupled to the craniotome handpiece

Tool can not be uncoupled

Deformation of the motor coupling on the craniotome handpiece

Have product repaired by the manufacturer

Tool shaft bent

-

Use a new tool

Pressure point cannot be passed

Automatic locking mechanism not working

Couple the tool with the slide actuated 7

Tool cannot be uncoupled even with the slide fully actuated

Fixation screw worn

Have product repaired by the manufacturer

Locking ring in locked position

Slide locked

Dura protector or attachment can not be fixed to the craniotome handpiece

Check the position of the swivel ring.

Dura protector can not be fixed to the craniotome handpiece

Dura protector too short

Dura protector (pivoted) 24 is difficult or not possible to turn

Bearing points soiled or damaged

Swivel ring 10/18/21 is not in unlocked position

Rotate the locking ring by 180° to unlock the slide

medium (15 mm)

GB743R

long (20 mm)

GB746R

short (10 mm)

GB747R

medium (15 mm)

GB748R

long (20 mm) 2 mm to 8 mm

Depth stop

-

Holding sleeve

GE420R

short

Craniotome reamer, reusable, coiled

GE520R

medium long

GE420SU

short

Dura protector foot standing on craniotome reamer

Number of rings on the craniotome reamer must match number of rings on the dura protector

Excessive friction at the bearing points

Have the craniotome handpiece and the dura protector repaired by the manufacturer

Wide gap between dura protector foot and craniotome reamer

Number of rings on the craniotome reamer must match number of rings on the dura protector

Poor progress in the cutting slit

Inspect the craniotome reamer

Badly soiled or blunt craniotome reamer

Clean the craniotome reamer, or use a new one

-

Cutting radius to small

Cut at a larger radius

-

Craniotome handpiece badly canted in the cutting slit

If possible, always work at the same reamer angle

Front face of the craniotome reamer C does not lie between the stop face A and base B on the dura protector foot

Bent guard bracket of the dura protector

Use a new dura protector

Motor runs with handpiece decoupled

Craniotome handpiece jammed

Have product repaired by the manufacturer

-

Motor safety stop in ”0”position

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

Strong running noise during normal operation

Worn gear or bearing

Have product repaired by the manufacturer

Dura protector (pivoted)

GB745R

GE620R

as far as

Dura protector (fixed)

GB744R

in symbol it will go

Dura protector too long

Excessive running noise

short (10 mm)

GB742R

Turn the swivel ring in the direction of the arrow

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

Craniotome handpiece not running

GB741R

Craniotome reamer, single-use, coiled

GE520SU

medium

GE620SU

long

GE429SU

short

GE529SU

medium

GE629SU

long

GE390R GE391R GE389R

∅ 1.0 mm ∅ 1.1 mm ∅ 1.2 mm

GE395R

∅ 1.5 mm

Wire pass drill for depth stop, reusable

GE390SU GE391SU GE389SU

∅ 1.0 mm ∅ 1.1 mm ∅ 1.2 mm

Spiral burr for depth stop, single-use

GE395SU

∅ 1.5 mm

Wire pass drill for depth stop, single-use

GE396R GE397R

∅ 5.0 mm ∅ 6.0 mm

Ball reamer "Twin Cut", reusable

GE396SU GE397SU

∅ 5.0 mm ∅ 6.0 mm

Ball reamer "Twin Cut", single-use

GE381R GE382R GE383R GE394R GE398R GE399R

∅ 1.0 mm ∅ 1.4 mm ∅ 1.8 mm ∅ 3.1 mm ∅ 5.0 mm ∅ 6.0 mm

Diamond reamer, reusable

GE394SU GE398SU GE399SU

∅ 3.1 mm ∅ 5.0 mm ∅ 6.0 mm

Diamond reamer, single-use

Craniotome reamer, single-use, straight serration

Spiral burr for depth stop, reusable

Art. no.

Designation

GE386SU GE387SU

∅ 4.0 mm ∅ 5.0 mm

GE392R

∅ 1.0 mm

Pin reamer, reusable

GE392SU

∅ 1.0 mm

Pin reamer, single-use

GB767SU

Spray nozzle, single-use

JF222R

Tray, 44 mm

JF223R

Tray, 64 mm

JK400, JK401

Containers

11.

Diamond reamer, single-use extra coarse

Technical data

Product

Weight

Size

Tools

Identification

GB740R S74931

65 g

∅ 17.5 x 59 mm

-

-

GB741R

10 g

∅ 13.5 x 37 mm

GE420R/SU GE429SU

I

GB742R

13 g

∅ 13.5 x 42 mm

GE520R/SU GE529SU

II

GB743R

15 g

∅ 13.5 x 47 mm

GE620R GE620SU GE629SU

III

GB744R

22 g

∅ 13.5 x 34 mm

GE389R/SU GE390R/SU GE391R/SU GE395R/SU

GB745R

17 g

∅ 13.5 x 30 mm

GE381R GE382R GE383R GE386SU GE387SU GE392R/SU GE393R/SU GE394R/SU GE396R/SU GE397R/SU GE398R/SU GE399R/SU

GB746R

10 g

∅ 17 x 45 mm

GE420R/SU GE429SU

I

GB747R

13 g

∅ 17 x 50 mm

GE520R/SU GE529SU

II

GB748R

16 g

∅ 17 x 55 mm

GE620R/SU GE629SU

III

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 available through your national B. Braun/Aesculap

agency, see Technical Service.

13.

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

3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 011265

11/12

V6

Änd.-Nr. 46258