Acculan 4 ELAN 4 electro – Attachments for small drill GA344 anddrill GA844

19

18

18

19

18

19

22 21

21

B

A

20

C

20

21

24

25

6

27

23

26

D E

F

GB870R

GB886R

GB871R

GB887R

GB872R

GB891R

GB878R

GB892R

GB881R

GB894R

GB882R

GB884R

GB896R

GB897R

en

Aesculap® Acculan 4 / ELAN 4 electro Attachments for small drill GA344 and drill GA844 Legend 1 Drill 2 Knob (for speed control) 3 Safety catch 4 Rotating sleeve 5 Arrow 6 Attachment with collet chuck 7 Unlocking sleeve 8 Tool coupling 9 Attachment with three jaw chuck 10 Tightening key 11 Tool coupling 12 Kirschner wire attachment 13 Clamping lever 14 Adjustment sleeve 15 Kirschner wire chuck 16 Drill attachment for radiolucent angle transmission 17 Adapter 18 Sagittal saw attachment 19 Tool attachment with L sagittal tool coupling 20 Button for adjusting the tool holder 21 L sagittal saw blade 22 Piece on saw blade for tool release 23 Oil spray adapter 24 Reciprocating Saw attachment 25 Tool attachment with Reciprocating Saw tool coupling 26 Reciprocating Saw blade (e.g. GP550R to GP576R) 27 Leaf spring on Reciprocating Saw blade for tool release 28 Screw attachment 29 Lever

Symbols on product and packages Caution Observe important safety information such as warnings and precautions in the instructions for use. Machine-readable, two-dimensional code The code contains a unique serial number which can be used for electronic tracking of the individual instrument. The serial number is based on the global standard sGTIN (GS1). Manufacturer

Date of manufacture

2

LOT

Manufacturer’s batch designation

SN

Manufacturer’s serial number

REF

Manufacturer’s article number Temperature limits during transport and storage

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage

Contents 1. 2. 2.1 2.2 2.2.1 2.3 2.4 2.5 3. 4. 4.1 4.2 4.3 5. 6. 6.1 6.1.1 6.1.2 6.1.3 6.1.4 6.2 6.3 6.3.1 6.3.2 7. 7.1 7.2 7.3 7.4 7.5 7.5.1 7.6 7.7 7.7.1 7.7.2 7.8

Applicable to... General information... Intended use... Main functions and design characteristics... Operating mode... Indications... Absolute contraindications... Relative contraindications... Safe handling... Product description... Scope of supply... Components required for operation... Operating principle... Preparation... Working with the device... System set-up... Connecting the accessories... Protection against inadvertent activation... Attaching/removing attachment for drill... Attaching and detaching the tool from the attachment... Function checks... Safe operation... Operating the product... Operating the screw attachment... Validated reprocessing procedure... General safety notes... General information... Preparations at the place of use... Preparation before cleaning... Cleaning/disinfection... Product-specific safety instructions for the reprocessing procedure... Manual cleaning with wipe disinfection... Mechanical cleaning/disinfection with manual pre-cleaning. Manual pre-cleaning with a brush... Mechanical alkaline cleaning and thermal disinfection... Inspection, maintenance and checks...

3 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 5 7 7 7 7 8 8 8 8 8 8 8 9 10 10 10 11

en 7.9 7.10 7.11 8. 9. 10. 11. 12. 12.1 12.2 12.3 12.4 13.

Packaging... Steam sterilization... Storage... Maintenance... Troubleshooting list... Technical Service... Accessories/Spare parts... Technical data... Classification acc. to Directive 93/42/EEC... Performance data, information about standards... Operating mode... Environmental conditions... Disposal...

1.

Applicable to

11 11 11 11 11 13 13 13 13 13 15 15 15

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

compatibility, see also https://extranet.bbraun.com

the

2.

General information

2.1

Intended use

Aesculap

Extranet

at

Task/Function The hand-held small drill GA344 and the drill GA844, combined with the appropriate attachment, is used for driving drilling, milling (medullary reaming), sawing and screwing tools. Application Environment The product is used in operating rooms in sterile zones outside of the explosion risk zone (such as areas with pure oxygen or anesthesia gases).

2.2

Main functions and design characteristics

Speed

Rotational direction

GB870R GB871R GB872R

0 min-1 to max. 320 min-1

GB878R GB881R GB882R GB884R GB886R GB887R GB894R

0 min-1 to max. 1 250 min-1

GB891R GB892R

0 min-1 to max. 15 750 min-1

GB896R GB897R

0 min-1 to max. 165 min-1 Right and left rotation, oscillation

2.2.1 Operating mode Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1) Drilling (clockwise/counterclockwise rotation) ■ 60 second application, 60 second pause ■ 6 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Medullary reaming (clockwise/counterclockwise rotation) ■ 30 second application, 30 second pause ■ 8 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Drilling (oscillation) ■ 15 second application, 15 second pause ■ 3 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw mode with GB891R ■ 30 second application, 60 second pause ■ 4 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw mode with GB892R ■ 30 second application, 60 second pause ■ 5 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Screwing with GB896R/GB897R ■ 10 second mechanical application, 10 second manual application, 30 second pause ■ 30 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Electrical systems generally heat up during continual operation. It is advised to give the system a break after use to cool down, as listed in the table on operating mode. Heating depends on the tool used and the load. After a certain number of repetitions, the system should cool down. This procedure prevents the system overheating as well as possible injury to the patient or user. The user is responsible for the use and adherence to the pause sequence described.

2.3

Indications

The small drill GA344 and the drill GA844, combined with the relevant attachment and tool, is used for separating, removing and shaping, hard tissue, cartilage and the like, as well as bone replacement material, to screw bone pins in and out, to drive screw tools and to set transfixion wires.

2.4

Absolute contraindications

The product is not licensed for use on the central nervous system or central circulatory system.

3

en 2.5

Relative contraindications

The safe and effective use of electrically driven products greatly depends on influences which can only be controlled by the user. Therefore the specifications provided represent framework conditions only. Clinically successful use of the product is dependent on the knowledge and experience of the surgeon. The surgeon must decide which structures it is sensible to treat and take into account the safety and warning information contained in these instructions for use.

3.

Safe handling

WARNING Risk of injury and material damage if this product is not used as intended! ► Use the product only for its intended purpose.

4.

Product description

4.1

Scope of supply

Art. no.

Designation

TA014553

Instructions for use, attachments for small drill GA344 and drill GA844

Attachments One of the following attachments (with corresponding chuck key as applicable) is additionally included with the delivery: Art. no.

Designation

GB870R GA031R

Medullary reaming attachment, large Jacobs chuck – and – Key for large Jacobs chuck

WARNING Risk of injury and damage to property due to improper handling of the product! ► Follow the instructions for use of all products used.

GB871R

Medullary reaming attachment AO large

GB872R

Medullary reaming attachment Hudson/Zimmer

GB878R

Drill attachment for Synthes 511.300

■ General risk factors associated with surgical procedures are not

GB881R

Drill attachment large Jacobs chuck

described in this documentation. ■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly. ■ The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the established operating techniques. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Ensure that the electrical installation of the room is consistent with the requirements of IEC/DIN EN. ► Do not operate the product in explosion-hazard areas. ► Sterilize product before use. ► When using the ECCOS holder system, adhere to the appropriate instructions for use for TA009721, see Aesculap Extranet at https://extranet.bbraun.com

4

– and – GA031R

Key for large three-jaw chuck

GB882R

Drill attachment small Jacobs chuck – and –

GA062R

Chuck key for small Jacobs chuck

GB884R

Drill attachment AO small

GB886R

Drill attachment Aesculap hexagon

GB887R

Drill attachment dental shaft

GB891R

Sagittal saw attachment

GB892R

Reciprocating Saw attachment

GB894R

Kirschner wire attachment

GB896R

Screw attachment AO small

GB897R

Screw attachment Aesculap hex

4.2

Components required for operation

4.3

Operating principle

■ Small drill GA344 (ready to use) or drill GA844 (ready to use) ■ Tool (depending on indication) The attachment can be attached to the drill in three different positions, each 120° difference. The attachment locks automatically when attached to the drill. The attachment can be removed by operating a rotating sleeve. A gear in the attachment changes the motor speed. The attachments have various integrated couplings on the working end, to enable attachment of various tools, with adapter if necessary.

en 5.

Preparation

Aesculap assumes no liability if the following rules are not followed: ► Do not use products from open or damaged sterile packaging. ► Prior to use, inspect the product and its accessories for any visible damage. ► Use the products and their accessories only if they are in perfect technical condition.

6.

Working with the device

WARNING Risk of infection and contamination! Product is delivered unsterilized! ► Sterilize the product before use pursuant to the operating instructions. WARNING Risk of injury and material damage due to accidental activation of the product! ► Products which are not being actively used must be secured against accidental activation (position OFF). WARNING Risk of injury and material damage due to inappropriate use of tools! ► Always follow the safety advice and information given in the instructions for use. ► When coupling/uncoupling, handle tools with cutting edges with care. WARNING Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check

► Please address your B. Braun/Aesculap partner or Aesculap Technical

Service with any inquiries in this respect; for a contact address, see Technical Service. 6.1.2 Protection against inadvertent activation To prevent the drill being inadvertently activated when changing a tool or accessory, the knob for speed control can be locked. Locking the knob for speed control 2: ► Twist the safety catch 3 to position OFF. The speed control knob 2 is blocked and the product 1 cannot be operated. Unlocking the knob for speed control 2: ► Twist the safety catch 3 to position ON. The speed control knob 2 is unlocked and the product 1 can be operated. Note For more information on the small drill GA344, see TA014550 and TA014551 (flyer). For more information on the drill GA844, see TA014436 and TA014437 (flyer). 6.1.3

Attaching/removing attachment for drill

WARNING Risk of injury when attaching/removing attachments/tools in the ON position through inadvertent activation of the product! ► Only attach/remove attachments/tools in the OFF position. ► Secure drill 1 from inadvertent activation with the safety catch 3, see

Protection against inadvertent activation. Coupling Note Aesculap recommends coupling the Reciprocating Saw attachment 24 with the label "TOP" upward, aligned to the drill. ► Push attachment 6/9/12/16/18/24/28 onto the drill 1 until it clicks

WARNING Risk of burns to skin and tissue through blunt tools or if product has not been maintained properly! ► Use tools only if they are in perfect condition. ► Replace blunt tools. ► Maintain the product properly, see maintenance guide.

into place. ► Pull on attachment 6/9/12/16/18/24/28 to check secure connection.

Uncoupling ► Turn sleeve 4 in the direction of the arrow 5 and simultaneously

remove the attachment 6/9/12/16/18/24/28 from the drill 1. 6.1.4

6.1

System set-up

6.1.1

Connecting the accessories

DANGER Risk of injury due to unapproved configuration using additional components! ► Ensure that the classification of all components used is consistent with the classification of the product (such as type BF or type CF). 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. All configurations must fulfill the fundamental standard IEC/EN/DIN 60601-1. The person connecting the devices with each other is responsible for the configuration and must ensure that the fundamental standard IEC/EN/DIN 60601-1 or relevant national standards. ► Follow the instructions for use of individual accessories.

Attaching and detaching the tool from the attachment

WARNING Risk of injury when attaching/removing attachments/tools in the ON position through inadvertent activation of the product! ► Only attach/remove attachments/tools in the OFF position. ► Ensure that the tool connector and attachment type are compatible.

Attachments with quick-mount chuck GB871R/GB872R/GB884R/GB886R/GB887R/GB896R/GB897R Coupling: ► Pull back on the unlocking sleeve 7. ► Insert the tool shaft in the correct position up to the stop in the tool holder 8 of the attachment 6. ► Release the unlocking sleeve 7. Tool is attached. ► Pull at tool to check that it is securely coupled. Note Information on operating the screw attachment 28, see Operating the screw attachment. 5

en Uncoupling: ► Pull back the unlocking sleeve 7. ► Remove tool. Attachments with three-jaw chuck GB870R/GB881R/GB882R Coupling: ► Open the three jaw chuck with the wrench 10. ► Insert the tool shaft in the correct position up to the stop in the tool holder 11 of the attachment 9. ► Close the three jaw chuck 10 and pull tight. ► Pull at tool to check that it is securely coupled. Uncoupling:

Drill attachment for radiolucent angle transmission GB878R The drill attachment allows connecting a radiolucent angle transmission for applying drill holes in the bone under radiographic control. The drill attachment is only suitable for use of the radiolucent angle transmission 511.300 from the Synthes company. ► Follow the instructions for the radiolucent angle transmission 511.300 in the operating instructions of the Synthes company.

Attach radiolucent angle transmission on drill attachment GB878R: ► Push the radiolucent angle transmission up to the stop on attachment 17 of the drill attachment. ► If necessary, slightly move the radiolucent unit.

► Open the three jaw chuck with the wrench 10. ► Remove tool.

Kirschner wire attachment GB894R WARNING Risk of injury when using long guide wires! ► Use Kirschner wire protection sleeve when using long guide wires. Note The special Kirschner wire chuck is recommended for the placement of guide wires. This quick-action chuck adapter allows quick and easy tensioning of drilling wires. When using long guide wires, a Kirschner wire protection sleeve must be used with the drill to prevent injury. For further information on GA344, see TA014550 and TA014551 (leaflet). For further information on GA844, see TA014436 and TA014437 (leaflet).

Detach radiolucent angle transmission on drill attachment GB878R: ► Forcefully pull out the radiolucent angle transmission from the drill attachment.

Attach/detach tool in radiolucent angle transmission: ► Follow the instructions for the radiolucent angle transmission 511.300 in the operating instructions of the Synthes company. Sagittal saw attachment GB891R Coupling: ► Insert saw blade 21 with marking "L" up into the slot of the tool holder 19, see Fig. A. Ensure that the side stops of the saw blade contact the tool holder. The tool engages. ► Pull on the attachment 21 to ensure a secure fit.

The following diameters can be set on the Kirschner wire attachment:

■ 0.6 mm to 1.2 mm ■ 1.2 mm to 2.2 mm ■ 2.2 mm to 3.2 mm

Uncoupling: Note For easier detachment of the tool, set the tool holder to 45° (see Fig. B) or 90° (see Fig. C), see tool holder adjustment.

Using a Kirschner wire: ► Ensure that the clamping lever 13 is in the starting position (deacti-

vated status). ► Set the adjusting sleeve 14 of the Kirschner wire attachment 12 to the desired diameter range: – Push back the adjusting sleeve 14 and turn until the desired diameter range has been reached. – Release the adjusting sleeve 14. Ensure that the adjustment sleeve 14 clicks into place. ► Insert the Kirschner wire into the Kirschner wire chuck 15 until the desired exposed length is achieved. The Kirschner wire is held in the intended position in the attachment by an automatic clamping mechanism. Tension the Kirschner wire: ► Pull on the clamping lever 13 and hold in the desired position.

The further the clamping lever is pulled back, the higher the tension of the Kirschner wire. Note The Kirschner wire will only remain tensioned with the clamping lever pulled back. If the clamping lever is released, it will move back into the starting position and the Kirschner wire is freely mobile.

6

► Move the gold bar 22 on the saw blade 21 slightly downward and hold

it to unlock the tool. ► Remove the saw blade 21 from the tool holder 19.

Adjusting the tool holder: ► Press the button for tool holder adjustment 20 and keep it depressed. ► Turn the tool holder 19 to the desired position (-90°/-45°/0°/45°/90°),

see Fig. B and Fig. C. ► Release the adjustment button of the tool holder 20 and secure the

tool holder 19 by clicking it into place. If necessary, slightly move the tool holder back and forth. Reciprocating Saw attachment GB892R Coupling: ► Insert connection side of Reciprocating Saw blade 26 into the slot in the tool holder 25, see Fig. D. The Reciprocating Saw blade clicks into place. ► Pull on the Reciprocating Saw blade 26 to verify a secure fit. Uncoupling: ► Gently press the gold piece for tool release on the Reciprocating Saw blade 27 downwards and keep pressed down. ► Remove the Reciprocating Saw blade 26 from the tool holder 25.

en 6.2

Function checks

The function test must be performed before each use and after each intraoperative change of attachment and tool. ► Check that the attachment is coupled properly. To test this, pull on the attachment. ► Check that the tool is coupled properly. To do this, pull on the tool. ► For GB891R: check that the tool attachment has locked into place. To do this, turn the tool attachment. ► Ensure that the tool blades are not mechanically damaged. ► Release drill for use (ON position). ► Run the drill shortly at maximum speed in right and left rotation. ► Make certain that the rotational direction is correct in each case. ► For GB896R/GB897R: ensure that there is both mechanical and manual functionality. ► Check the product for damage, abnormal operation noises, heavy vibration and excessive heat. ► Do not use the product if it is damaged or defective. ► Set aside the product if it is damaged.

6.3

Safe operation

WARNING Coagulation of patient tissue or risk of burns for patients and user through hot product! ► Do not use drill attachments to operate milling tools. ► Do not use the medullary milling attachments for acetabulum milling. ► Cool the tool during operation. ► Keep product/tool out of the reach of patients. ► Let the product/tool cool down. ► Use a cloth to protect against burns when changing the tool. WARNING Risk of infection from aerosol formation! Risk of injuries caused by particles coming loose from the tool! ► Use suitable protection (such as waterproof protective clothing, face mask, safety gases, suction). 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 and damage to the tool/system! The rotating tool may get caught in drapes (such as textiles). ► Do not let the tool come into contact with drapes (such as textiles) during operation.

6.3.1 Operating the product Note For more information on operation of the small drill GA344, see TA014550 and TA014551 (flyer). For more information on operation of the drill GA844, see TA014436 and TA014437 (flyer). ► Start the drill at a moderate speed. ► Apply moderate pressure to prevent slipping. ► Do not bend the tool, otherwise there is a danger of breakage. ► When screwing bone screws and bone pins in and out: ensure correct

rotation direction setting. ► Use the following attachments for drilling:

– GB881R – GB882R – GB884R – GB886R – GB887R ► Use the following attachments for milling (medullary reaming): – GB870R – GB871R – GB872R ► Use the following attachment for the placement of Kirschner wires: – GB894R ► Use only the following attachment for using the radiolucent angle transmission 511.300 from the Synthes company: – GB878R ► Use the following attachments for sawing: – GB891R – GB892R ► Use the following attachments for driving screw tools: – GB896R – GB897R 6.3.2

Operating the screw attachment

WARNING Risk of injury! ► Do not completely screw bone screws in mechanically. ► Perform the final rotations and locking of the bone screws manually. WARNING Risk of injury and damage to property due to improper handling of the product! ► Follow the instructions for use of the implant system that is used. Mechanical operation ► Activate the knob for speed control 2. Do not activate lever 29 when doing so. Manual operation with ratcheting function ► Pull lever 29 to the stop and hold.

WARNING Risk of injury through inadvertent release of the saw blade! ► Do not press the sagittal saw blade tool release during operation. ► Do not press the Reciprocating Saw blade tool release leaf spring during operation. ► Check for secure fixation of the tool after any tool change.

► Move product clockwise.

The rotational movement is transferred to the coupled screw tool. ► Move product counterclockwise.

The ratcheting function is active. The product can be moved into the starting position without also moving the screw tool.

7

en 7. 7.1

Validated reprocessing procedure General safety notes

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. 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 It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing 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 up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

7.2

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 neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine. On stainless steel, residues containing chlorine or chloride (such as surgical residues, drugs, saline solutions in water for cleaning, disinfection and sterilization) may lead to corrosion (pitting corrosion, tensile corrosion) and thus to the destruction of the product. These must be removed by rinsing thoroughly with demineralized water and then drying. Perform 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: ■ Visual material changes (such as fading or color changes in titanium or aluminum). For aluminum, the application/process solution only needs to be pH >8 to cause visible surface changes. ■ Material damage (such as corrosion, cracks, breaks, premature aging or swelling). ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion ► For further detailed information on hygienically safe and material-preserving/value-preserving reprocessing, see www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

8

7.3

Preparations at the place of use

► Remove all attached components from the product (tool and accesso-

ries). ► Detach the attachment from the drill. ► Remove any visible surgical residues as much as possible with a damp,

lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for

cleaning and disinfection within 6 hours.

7.4

Preparation before cleaning

► Before the first automatic cleaning/disinfection: attach ECCOS holders

in a suitable tray. ► Insert the products in the correct position into the ECCOS fixations, see

Fig. E. Kirschner wire attachment GB894R ► Set adjustment sleeve to the largest Kirschner wire diameter.

7.5

Cleaning/disinfection

7.5.1

Product-specific safety instructions for the reprocessing procedure

CAUTION Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for plastic material and high-grade steel, – do not attack softeners (e.g. in silicone). ► Do not use cleaning agents that contain acetone. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum temperature of 60 °C during chemical cleaning and/or disinfection. ► Do not exceed the maximum temperature of 96 °C during thermal disinfection with FD water. ► Dry the product for at least 10 minutes at a maximum of 120 °C. Note The indicated drying time is a guide time only. It must be checked taking into account the specific conditions (e.g. load) and if applicable adjusted.

en 7.6

Manual cleaning with wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Pre-cleaning

RT (cold)

≥2

-

D-W

Until visually clean

II

Cleaning with enzyme solution

RT (cold)

≥2

0.8

D–W

pH-neutral*

III

Intermediate rinse

RT

≥5

-

D-W

–

IV

Drying

RT

-

-

-

–

V

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

VI

Final rinse

RT (cold)

0.5

-

FD–W

–

VII

Drying

RT

-

-

-

–

D–W: FD–W: RT: *

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature Validated with enzyme cleaner “Cidezyme Johnson & Johnson”

► Do not clean the product in a ultrasonic bath and do not immerse the

product in any fluids. Let any fluid incursions drain out immediately, otherwise there is a danger of corrosion and loss of function. Phase I ► Flexible components (such as sleeves) will move during cleaning. ► Clean the product under running water, using a suitable plastic clean-

ing brush until all visible residues have been removed from the surfaces. ► Brush cannulation with cleaning brush TA011944 and difficult to access surfaces with a suitable plastic cleaning brush for at least 1 min.

Phase VI ► Rinse disinfected surfaces after the prescribed reaction time for at least 1 minute under running demineralized water. ► Drain any remaining water fully. Phase VII ► Dry the product in the drying phase with suitable equipment (such as lint-free cloths, pressurized air).

Note For details on difficult to access surfaces, see Acculan pre-cleaning and care information TA016000 (available in Aesculap Extranet at https://extranet.bbraun.com). Phase II ► Follow the operating instructions of the enzyme cleaner with regard to

correct concentration, dilution, temperature and water quality. ► Spray products with a pH neutral enzyme solution, let soak in for at

least 2 minutes and then wipe off. Phase III ► Flexible components (such as sleeves) will move during cleaning. ► Rinse product under running tap water for at least 5 minutes. ► Follow the operating instructions of the enzyme cleaner with regard to

correct concentration, dilution, temperature and water quality. ► Contamination should be removed with a lint-free cloth or soft brush moistened with enzyme cleaner. ► Flexible components (such as sleeves) and cannulations should be rinsed for 20 seconds with the water pistol (cold water, at least 2,5 bar). ► After manual cleaning, check visible surfaces and areas of flexible components for residues. ► If necessary, repeat the cleaning process (phase 1 to 3). Phase IV ► Dry the product in the drying phase with suitable equipment (such as

lint-free cloths, pressurized air). Phase V ► Wipe all surfaces of the product with a single-use disinfecting wipe.

9

en 7.7

Mechanical cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfection device must fundamentally have a tested efficacy (such as FDA approval or CE label pursuant to DIN EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals. 7.7.1

Manual pre-cleaning with a brush

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry/Note

I

Rinsing

RT (cold)

-

-

D–W

Until visually clean

II

Brushes

RT (cold)

-

-

D–W

Until visually clean

D–W: RT:

Drinking water Room temperature

► Do not clean the product in a ultrasonic bath and do not immerse the

product in any fluids. Let any fluid incursions drain out immediately, otherwise there is a danger of corrosion and loss of function. ► For Kirschner wire attachment GB894R: Set the adjustment sleeve to the greatest Kirschner wire diameter. Phase I ► Flexible components (such as sleeves) will move during cleaning. ► Thoroughly clean the product under running water.

Phase II ► Flexible components (such as sleeves) will move during cleaning. ► Brush cannulation with cleaning brush TA011944 and difficult to

access surfaces with a suitable plastic cleaning brush for at least 1 min. ► After manual preparation, check visible surfaces for residue and repeat

the pre-cleaning process as needed. Note For details on difficult to access surfaces, see Acculan pre-cleaning and care information TA016000 (available in Aesculap Extranet at https://extranet.bbraun.com).

7.7.2 Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemistry/Note

I

Pre-rinse

<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 disinfection

90/194

5

FD–W

-

V

Drying

-

-

-

mind. 10 min at max. 120 °C

D-W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline 10

en ► For Kirschner wire attachment GB894R: Set the adjustment sleeve to

the greatest Kirschner wire diameter. ► Insert the product in the correct position into the ECCOS fixation, see Fig. E. ► Then connect the interior rinse device to the ECCOS holder and connect to the rinse connector of the cleaning/disinfection device/rinse cart. ► After automatic cleaning/disinfection, check visible surfaces for residues and repeat the cleaning/disinfection process as needed.

7.8

Inspection, maintenance and checks

► Allow the product to cool down to room temperature. ► Spray product after every cleaning and disinfection with oil spray

adapter 23 GB600880 (green) approx. 2 sec with Aesculap STERILIT Power Systems oil spray GB600, see Fig. F. Note Aesculap additionally recommends occasional spraying of moving parts (such as knobs, couplings, cover lids) with the Aesculap STERILIT-PowerSystems oil spray. ► Check the product after each cleaning and disinfection for the follow-

ing: cleanliness, damage, function, abnormal operation noise, excessive heat or heavy vibration. ► Set aside the product if it is damaged.

7.9

Packaging

► Always follow the instructions for use of the respective packaging and

storage devices (e.g. instructions for use TA009721 for AesculapECCOS holder system). ► Insert the products in the correct position into the ECCOS fixations, see Fig. E. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

9.

7.10 Steam sterilization Note Remove all attached components from the product (tools, accessories) before sterilization. ► 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). ► Use a validated sterilization method: – Steam sterilization using fractional vacuum process – Steam sterilizer DIN EN 285 and validated pursuant to DIN EN ISO 17665 – Sterilization using the fractionated vacuum process at 134 °C, holding time 5 min When sterilizing multiple products in one steam sterilizer: ► Ensure that the maximum permitted load specified by the manufacturer for the steam sterilizer is not exceeded.

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

a dry, dark, temperature-controlled area.

8.

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.

Troubleshooting list

► Have defective products repaired by Aesculap Technical Service, see Technical Service.

Issue

Cause

Detection

Remedy

Product becomes too hot

Excessive use

Attachment very hot

Follow operating instructions (operating mode).

Defective attachment drive/ball bearings

Attachment very hot

Follow operating instructions (preparation, care). Preventative: lubricate attachment before every sterilization. Have the manufacturer repair the attachment.

Fall damage, product defective

Attachment very hot

Have the attachment repaired by the manufacturer.

Blunt tool

Heating of tool and product

Change tool.

Product is operating in left rotation mode

Serrated tool run in counterclockwise mode

Use serrated tools only in clockwise mode.

Attachment defective

Attachment very hot

Follow operating instructions (preparation, care). Preventative: lubricate attachment before every sterilization. Follow operating instructions (operating mode). Have the attachment repaired by the manufacturer.

Blunt tool

Tool blades worn out

Change tool.

Insufficient power

11

en Issue

Cause

Detection

Remedy

Loud running noise

Defective attachment drive/ball bearings

Loud, perceptible noise during operation

Follow operating instructions (preparation, care). Preventative: lubricate attachment before every sterilization. Have the manufacturer repair the attachment.

Attachment does not attach or detach.

Attachment not compatible

Attachment doesn't engage

Use the compatible attachment for drill.

Connection on attachment deformed/defective

Attachment is difficult to couple or cannot be coupled

Have the manufacturer repair the attachment.

Coupling on drill deformed/defective

Attachment is difficult to couple or cannot be coupled

Have the manufacturer repair the drill.

Sleeve on drill hard to move

Attachment doesn't engage

Turn and hold the drill sleeve, then attach the attachment. Turn the sleeve back if necessary. Preventative: lubricate the sleeve on the drill before each sterilization.

Incompatible tool

Tool does not click into place

Use the tool compatible with the attachment.

Tool connector deformed/defective

Tool is difficult to couple or cannot be coupled

Use a new tool.

Coupling on attachment deformed/defective

Tool is difficult to couple or cannot be coupled

Have the manufacturer repair the attachment.

Tool coupling dirty

Tool is difficult to couple or cannot be coupled

Clean tool or use a new tool. Clean the attachment.

For GB894R: Kirschner wire does not insert into the Kirschner wire chuck

Kirschner wire chuck not set correctly

Diameter of the Kirschner wire is not consistent with the scale setting

Set the adjustment sleeve to the right Kirschner wire diameter.

For GB894R: Kirschner wire not turning

Kirschner wire chuck not set correctly

Diameter of the Kirschner wire is not consistent with the scale setting

Set the adjustment sleeve to the right Kirschner wire diameter.

Open the clamping lever

Open the clamping lever

Close the clamping lever.

Clamping lever not pulled back with sufficient force

Kirschner wire not turning

Pull back the clamping lever forcefully and hold it.

Attachment not fully attached to the drill

Attachment can be pulled out of the drill Correctly attach the attachment and perform a function test.

Tool not fully attached to the attachment

Tool can be pulled out of the tool coupling

Attachment defective

Drill turning, but attachment is not turn- Have the manufacturer repair the attachment. ing.

Drill defective

Drill not turning

Have the manufacturer repair the drill.

The safety catch of the drill is in the OFF position

Safety catch is in OFF position

Turn the safety catch into the ON position.

For GB896R/GB897R: lever pulled

For GB896R/GB897R: lever pulled

For GB896R/GB897R: do not pull lever for mechanical operation.

For GB896R/GB897R: changing between mechanical and manual operation is not possible.

Lever mechanism defective

Lever is difficult to move or cannot move. Clean and oil attachment. Lever is bent. Have the manufacturer repair the attachment. Lever does not move itself back to the Alternatively, use a screwdriver handle. starting position.

Ratcheting mechanism defective

Lever is difficult to move or cannot move. Clean and oil attachment. No ratcheting function in manual opera- Have the manufacturer repair the attachment. tion. Alternatively, use a screwdriver handle.

Oil spray adapter not attachable

Oil spray adapter not compatible

Oil spray adapter not attachable

Tool does not attach or detach.

Tool not moving

12

Correctly attach the tool and perform a function test.

Use the compatible oil spray adapter for GA344.

en 10. Technical Service

12. Technical data

WARNING Danger to life of patients and users if the product malfunctions and/or protective measures fail or are not used! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. ► Do not modify the product.

12.1 Classification acc. to Directive 93/42/EEC

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► For service and repairs, please contact your national B. Braun/Aesculap agency.

Art. no.

Designation

Class

GB870R

Medullary reaming attachment, large Jacobs chuck

IIa

GB871R

Medullary reaming attachment AO large

GB872R

Medullary reaming attachment Hudson/Zimmer

GB878R

Drill attachment for Synthes 511.300

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] Other service addresses can be obtained from the address indicated above.

GB881R

Drill attachment large Jacobs chuck

GB882R

Drill attachment small Jacobs chuck

GB884R

Drill attachment AO small

GB886R

Drill attachment Aesculap hexagon

GB887R

Drill attachment dental shaft

GB891R

Sagittal saw attachment

GB892R

Reciprocating Saw attachment

11. Accessories/Spare parts

GB894R

Kirschner wire attachment

GB896R

Screw attachment AO small

GB897R

Screw attachment Aesculap hex

Art. no.

Designation

GB257R

ECCOS sieve basket with fixation for GA344

GB262R

ECCOS sieve basket with fixation for GA844

GB600

STERILIT Power Systems oil spray

GB600880

Oil spray adapter for GA344/GA844

TA011944

Cleaning brush

GB715R

ECCOS holder single

GB716R

ECCOS holder triple

GA031R

Key for large Jacobs chuck

GA062R

Chuck key for small three-jaw chuck

TA014552

Instructions for use, attachments for small drill GA344 and drill GA844 (for ring binder)

TA014553

Instructions for use, attachments for small drill GA344 and drill GA844 (flyer)

12.2 Performance data, information about standards Rotational direction

Right and left rotation, oscillation

Conforming to standard

IEC/DIN EN 60601-1

The product was subject to 500 preparation cycles as a test by the manufacturer and has passed. The performance data for the individual attachments can be found in the table below.

13

en Drill attachments Attachment

Connector

Dimensions Length x ∅ [mm] ±5 %

Weight [g] ±10 %

Max. speed [min-1], approx.

Max. torque [Nm], approx.

Cannulation [mm]

GB878R

for Synthes 511.300

111 x 27

181

1 250

1.5

3.2

GB881R

Large Jacobs chuck ∅ 0.5 mm to 7.4 mm

89 x 29

163

1 250

1.5

3.2

GB882R

Small Jacobs chuck ∅ 0.5 mm to 4 mm

76 x 22

100

1 250

1.5

3.2

GB884R

AO small

60 x 22

66

1 250

1.5

2.8

GB886R

Aesculap hex

57 x 24

67

1 250

1.5

3.2

GB887R

Dental

56 x 22

50

1 250

1.5

1.8

Medullary milling attachments Attachment

Connector

Dimensions Length x ∅ [mm] ± 5 %

Weight [g] ±10 %

Max. speed [min-1], approx.

Max. torque [Nm], approx.

Cannulation [mm]

GB870R

Large Jacobs chuck ∅ 0.5 mm to 7.4 mm

105 x 29

230

320

5

3.2

GB871R

AO large

88 x 29

170

320

5

3.2

GB872R

Hudson/Zimmer

86 x 25

150

320

5

3.2

Saw attachments Attachment

Connector

Dimensions Length x ∅ [mm] ±5 %

Weight [g] ±10 %

Max. oscillation frequency [min-1], approx.

Cannulation [mm]

GB891R

L sagittal saw blade

74 x 33.5

179

15 750

–

GB892R

Reciprocating Saw blade

135 x 24.5

166

15 750

–

Kirschner wire attachment Attachment

Connector

Dimensions L x W x H [mm] ±5 %

Weight [g] ± 10 %

Max. speed [min-1], approx.

Cannulation [mm]

GB894R

Kirschner wire ∅ 0.6 mm to 3.2 mm

92 x 27 x 124

179

1 250

3.2

Screw attachments Attachment

Connector

Dimensions L x ∅ x H [mm] ± 5 %

Weight [g] ±10 %

Max. speed [min-1], approx.

Cannulation [mm]

GB896R

AO small

95 x 28 x 129.5

235

165

1.7

GB897R

Aesculap hex

92 x 28 x 129.5

231

165

1.7

14

en 13. Disposal

12.3 Operating mode Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1) Drilling (clockwise/counterclockwise rotation) ■ 60 second application, 60 second pause ■ 6 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Medullary reaming (clockwise/counterclockwise rotation)

■ 30 second application, 30 second pause ■ 8 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Drilling (oscillation)

■ 15 second application, 15 second pause ■ 3 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C

Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. Adhere to national regulations when disposing of or recycling the product, its components and its packaging! The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass includes disassembling instructions for the product, as well as information for proper disposal of components harmful to the environment.) Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the European Union, disposal is taken care of by the manufacturer as a free-of-charge service. ► Detailed information concerning the disposal of the product is avail-

able through your national B. Braun/Aesculap agency, see Technical Service.

Saw mode with GB891R

■ 30 second application, 60 second pause ■ 4 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw mode with GB892R

■ 30 second application, 60 second pause ■ 5 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Screwing with GB896R/GB897R

■ 10 second mechanical application, 10 second manual application, 30 second pause

■ 30 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C 12.4 Environmental conditions Operation

Storage and transport

Temperature

10 °C to 27 °C

-10 °C to 50 °C

Relative humidity

30 % to 75 %

10 % to 90 %

Atmospheric pressure

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

15