micro-Line craniotomes macro-Line craniotome

11 10

9 8

1

22

12

7

2

3

5

C

A

A 4

B A A

3

4

3

D 3

E 3

7

5

7

6

E

D

3.2

Components required for operation

GB265R/GB268R

Aesculap® micro-Line craniotomes/macro-Line craniotome

Flexible shaft GA176 (1.8 m) –or– Flexible shaft GA173 (2.3 m)

Legend 1 Borehole/Dura protector 2 Support foot (rotatable for GB266) 3 Pivot foot (GB266)/support foot (GB298) 4 Knurled sleeve 5 Slot 6 Pegs 7 Reamer (GC303R) 8 Flat section 9 Reamer adapter 10 Sleeve 11 Drive unit 12 Pin 13 Clamping lever (for GB299 only) 14 Macro coupling 15 Centering lug (motor unit) 16 Face plate (motor unit) 17 Lug (macro motor unit) 18 Fixing screw 19 Lubrication point (for clamping lever) 20 Release button (micro motor unit) 21 Gearing 22 Open position 23 Locked position 24 micro connection/INTRA coupling A B C D E

micro-Line craniotome with pivoted dura protector –or– micro-Line craniotome with fixed dura protector

microspeed uni micro 150 motor GD678 –or– microlan 100 pneumatic motor GA553 GB299

macro-Line craniotome with fixed dura protector GB299 Flexible shaft GA156 (1.6 m) with Elan EC and foot control –or– Flexible shaft GA172 (2.1 m) with Elan EC and foot control AIRLAN pneumatic motor GA200

3.3

Intended use

The micro-Line craniotomes/macro-Line craniotome are used to excise larger bone flaps from the skullcap in neurosurgical procedures.

3.4

Operating principle

The micro-Line craniotomes/macro-Line craniotome are operated at revolution speeds of up to 20 000 1/min (only in clockwise running mode). The reamer removes the bone material, with the support foot serving as reamer guide and dura protector at the same time. The micro-Line craniotomes/macro-Line craniotome are designed for tool-less changing/clamping of the reamer and the support foot.

4.

Boreholes Straight incisions Circular Arc incisions Borehole Full Circle incision

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Prior to use, inspect the micro-Line craniotomes/macro-Line craniotome and their accessories for any visible damage. ► Use micro-Line craniotomes/macro-Line craniotome and their accessories only if they are in perfect condition.

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

5.

Working with the micro-Line craniotomes/macro-Line craniotome

5.1

System set-up

Note Products marked as unsterile must be sterilized, prior to use, according to respective instructions, see Steam sterilization.

1.

Applicable to

Risk of injury due to accidental activation of motor unit! ► Change tools only with the motor unit uncoupled.

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

at www.extranet.bbraun.com WARNING

2.

Safe handling

CAUTION Federal law restricts this device to sale by, or on order if 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.

3.

Product description

3.1

Scope of supply

Risk of contamination and infection caused by unsterile components in the sterile area! ► Use only sterile or sterilized parts in the sterile area. WARNING

CAUTION

Damage to the product due to incorrect handling or operation! ► Couple the product only while the motor is inactive. ► Make certain that the maximum speed of 18 000 1/min is correctly set on the motor unit.

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.

Connecting macro-Line craniotome GB299 to the motor unit micro-Line craniotome with pivoted dura protector GB265R Designation

Art. no.

Drive unit (with micro coupling)

GB267R

Dura protector (pivoted)

GB266R

Reamer

GC303R

Damage to the craniotome due to incorrect handling or operation! ► Craniotome must only be coupled while the motor is inactive. CAUTION ► Release clamping lever 13 towards the OPEN position. ► Push the handpiece onto centering lug 15 until the handpiece touches face plate 16 and lug 17 engages in the

recess at the handpiece. ► Tighten clamping lever 13 towards the CLOSE position.

micro-Line craniotome with fixed dura protector GB268R Designation

Art. no.

Drive unit (with micro coupling)

GB267R

Insert the dura protector (fixed)

GB298R

Reamer

GC303R

Moving the clamping lever to be parallel with the motor unit ► Tighten clamping lever 13 hand-tight. ► Loosen fixing screw 18 with hexagon wrench TA004801 until the toothing 21 disengages. ► Move clamping lever 13 to the intended position and engage toothing 21. ► Tighten fixing screw 18 with hexagon wrench TA004801.

Connecting micro-Line craniotome GB265R/GB268R to the motor unit Damage to the craniotome due to incorrect handling or operation! ► Craniotome must only be coupled while the motor is inactive.

macro-Line craniotome with fixed dura protector GB299 Designation

Art. no.

Insert the dura protector (fixed)

GB298R

Reamer

GC303R

CAUTION ► Push the handpiece with INTRA coupling 24 onto centering lug 15 until it touches face plate 16 and engages

there.

Uncoupling macro-Line craniotome GB299 from the motor unit ► Release clamping lever 13 towards the OPEN position. ► Remove the handpiece.

Uncoupling micro-Line craniotome GB265R/GB268R from the motor unit ► Press release button 20 and remove the handpiece.

Inserting a reamer/Coupling a support foot ► Push sleeve 10 forward. ► Insert reamer 7 in reamer adapter 9 and rotate it until flat section 8 engages. Check that reamer 7 cannot be

Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

6.2

General information

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

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.

Test run

6.3

pulled out. ► Let sleeve 10 slide back, see Fig. 1.

Reamer 7 is coupled now. ► Push support foot 3 onto drive unit 11, see Fig. 2. ► Check that knurled sleeve 4 is in open position 22, slot 5 is positioned above pin 12 and stud 6 of reamer 7 is

seated in borehole/dura protector 1. ► Turn knurled sleeve 4 counterclockwise to locked position 23, see Fig. 3.

The support foot is coupled now.

Removing the support foot/Removing the reamer ► Turn knurled sleeve 4 clockwise to open position 22 and remove support foot 3 towards the front end.

Support foot 3 is detached now. ► Push sleeve 10 forward and pull out reamer 7 from reamer adapter 9.

Reamer 7 is uncoupled now.

5.2

Function checks

► Check that the craniotome, the reamer and the support foot are mounted securely. ► Briefly run the craniotome at maximum speed. Check for proper and reliable functioning.

5.3

Safe operation Risk of burns to patient and user due to hot motor/hot tool! ► Put down the motor/hot tool beyond reach of the patient. ► Use a cloth to protect against burns when changing the motor or tool.

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. ► Prior to the first mechanical cleaning/disinfection process, mount the Eccos holder GB682R and GB686R in a

WARNING

WARNING

Dismantling prior to carrying out the reprocessing procedure

► Disassemble the product immediately after use, as described in the respective instructions for use.

Risk of injury and material damage due to inappropriate use of handpieces or motors! ► Always follow the safety advice and information given in the instructions for use of the handpieces and motors. ► Do not exceed the specified maximum motor speed.

suitable tray (e.g. JF214R).

6.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect macro-Line craniotome GB299 manually.

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

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

CAUTION

WARNING Risk of infection and contamination due to unsterile parts! ► Use only sterile/sterilized parts in the sterile area. WARNING

CAUTION

Note The reamer must be applied in right-cutting mode!

Risk of damage to the macro-Line craniotome 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 micro-Line craniotome 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, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable temperature of 60 °C.

Excising a bone flap from the skullcap Note Ensure that blunt reamers are replaced immediately! ► Apply some boreholes A and connect them by straight incisions B or arc incisions C, see Fig. 4. running the motor

at its maximum speed of 20 000 1/min. Connecting a borehole with a circular incision ► Apply one borehole D. ► Starting from borehole D, perform a full circle cut E, cut out a disk, see Fig. 5 running the motor at its maximum speed of 20 000 1/min. ► micro/macro line craniotome is applied in the borehole, making sure that reamer 7 points in the cutting direction, see Fig. 5. Dura protector 1 of support foot 2 slides on the dura and protects it against damage caused by reamer 7.

6.

Validated reprocessing procedure

6.1

General safety instructions

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

Note The indicated drying temperature is a guide temperature only. It must be checked taking into account the specific conditions (e.g. load) and adjusted if applicable. ► Do not clean motors/handpieces by ultrasonic treatment and do not immerse them in any liquids. To avoid the

risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately.

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with

Chapter Manual cleaning/disinfecting and subsection:

■ GB265R ■ GB268R ■ GB299

■ Chapter Manual cleaning and wipe disinfecting

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

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

■ 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.)

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.

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

Mechanical alkaline cleaning and thermal disinfecting

■ GB265R ■ GB268R

■ Insert the product in its proper position in the Eccos holder. – For drive unit GB267R: Eccos holder GB682R – For support foot GB298: Eccos holder GB686R

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 dis-

infecting solution.

► Place the macro-Line craniotome on the tray in such a way that it is protected against damage. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

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

6.11 Steam sterilization

Manual cleaning and wipe disinfecting

Note The product may only be sterilized when dismantled.

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

► Prior to sterilization, remove any tools and adapters and uncouple the handpiece from the motor unit. ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

I

Cleaning

RT (cold)

-

-

D–W

-

► Validated sterilization process

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

-

-

-

-

opening any valves and faucets).

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 cleaning brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Phase II ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure. Phase III ► Wipe all surfaces of the product with a single-use disinfectant wipe. Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

6.8

– 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.

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

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

7.

Maintenance

To ensure reliable operation, the product must be maintained at least once a year. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

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.

8.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Intense/loud running noise

Motor unit can be pulled out from the handpiece

Motor unit not coupled correctly

Couple the motor unit correctly, see Connecting micro-Line craniotome GB265R/GB268R to the motor unit

Handpiece hot

Gearing worn

Have repaired by manufacturer

Lack of power at handpiece

Intense/loud running noise

Gearing worn

Have repaired by manufacturer

Inadequate power at handpiece

Deficient cutting performance

Blunt tool

Replace the tool

–

Motor unit not running correctly

See instructions for use of the motor unit

Coupling parts broken

Coupling defective

Have repaired by manufacturer

Motor unit running, but not powering the handpiece

Defective gearings

Have repaired by manufacturer

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: 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.

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. ► After every cleaning and disinfection, and prior to sterilization, lubricate the product at the reamer adapter 9,

lubrication point (for clamping lever) 19 and in the borehole for macro connection 14/micro connection 24 with a drop of STERILIT Power Systems drip lubricator GA059. –or– ► Spray through GB265R and GB266R with Aesculap-STERILIT oil spray GB600 with adapter GB600810 for approx. 1 second. ► 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. ► Prior to an extended period of non-use, always store attachments cleaned and dried according to the instructions.

6.10 Packaging ► 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 micro-Line craniotome in its proper position in the Eccos holder and put it on the tray in such a way

that the product is protected against damage.

Tool not moving

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/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.

10.

Accessories/Spare parts

Art. no.

11.4 Ambient conditions Operation

Designation

Storage and transport

Temperature

GA059

STERILIT Power Systems drip lubricator

TA004801

Hexagon wrench

GB298

Dura protector (pivoted)

GB600

Aesculap STERILIT oil spray with adapter GB600810

GC303R

Reamer

GB682R

Eccos holder for drive unit GB267R

GB686R

Eccos holder for support foot GB298

GB459R

Eccos mounting set for holders

TA005834

Instructions for use of craniotomes

Relative humidity

11.

Atmospheric pressure

Technical data

Classification acc. to Directive 93/42/EEC

12.

Material #

Designation

Class

GB265R

micro-Line craniotome with pivoted dura protector

IIa

GB268R

micro-Line craniotome with fixed dura protector

IIa

GB299

macro-Line craniotome with fixed dura protector

IIa

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. 11.1 micro-Line craniotome with pivoted dura protector GB265R

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

Size

∅ 29 mm

Length

133 mm

Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA

Weight

approx. 200 g

TA-Nr. 005834

Maximum revolution speed

20 000 1/min

Gear ratio

1:1

Minimum bore hole diameter for inserting the craniotome

9 mm

Width of reamer slot

2 mm to 3 mm

Reaming thickness (max.)

16 mm (conical)

11.2 micro-Line craniotome with fixed dura protector GB268R Size

∅ 29 mm

Length

133 mm

Weight

approx. 200 g

Maximum revolution speed

20 000 1/min

Gear ratio

1:1

Minimum bore hole diameter for inserting the craniotome

9 mm

Width of reamer slot

2 mm to 3 mm (conical)

Reaming thickness (max.)

16 mm

11.3 macro-Line craniotome with fixed dura protector GB299 Size

∅ 29 mm

Length

95 mm

Weight

approx. 200 g

Maximum revolution speed

20 000 1/min

Gear ratio

1:1

Minimum bore hole diameter for inserting the craniotome

9 mm

Width of reamer slot

2 mm to 3 mm (conical)

Reaming thickness (max.)

16 mm

01/14

V6

Änd.-Nr. 48673