Acculan 4 – Attachments

17 18

25

19

A

B 26

C

GB623R

GB621R

GB657R

GB660R

GB663R

GB639R

GB667R

GB176R

GB664R

GB645R

GB668R

GB184R

GB665R

GB641R

GB669R

GB628R

GB670R

XF457R

GB620R

en

Aesculap® Acculan 4 Attachments Legend 1 Drill 2 Knob (for speed control) 3 Safety catch 4 Rotating sleeve 5 Arrow 6 Reamer attachment with quick-action chuck adapter 7 Unlocking sleeve 8 Tool coupling 9 Drill attachment with quick-action chuck adapter 10 Drill attachment keyless Jacobs chuck 11 Locking sleeve 12 Attachment with Jacobs chuck 13 Tightening key 14 Zimmer chuck with Hudson/Zimmer coupling 15 Unlocking sleeve 16 Adapter AO large to DHS/DCS step drill 17 Sagittal saw attachment 18 Tool holder with Rapid Action tool attachment 19 Knob for tool release 20 Drill attachment for Synthes radiolucent angle transmission 21 Kirschner wire attachment 22 Clamping lever 23 Adjustment sleeve 24 Kirschner wire chuck 25 Rapid Action saw blade 26 Oil spray adapter The diagrams are only schematic.

Symbols on product and packages Caution Observe important safety information such as warnings and precautions in the instructions for use. Two-dimensional machine readable code The code contains a unique serial number that can be used for electronically tracking single instruments. The serial number is based on the worldwide standard sGTIN (GS1). Manufacturer

Date of manufacture

Manufacturer's batch name Manufacturer serial number Manufacturer order number

2

According to US federal law, this product may only be sold by a physician or by the order of a physician CE mark according to Regulation (EU) 2017/745 Medical device

Contents 1. 1.1 1.2 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 6.2 6.3 6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.4.8 6.4.9 6.5 6.6 7. 7.1 7.2 7.3 7.4 7.5

About this document... Scope... Warnings... 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... Coupling and uncoupling of attachment to drill and reamer . Attaching and detaching the tool from the attachment... Attachments with quick-action chuck GB623R/GB657R/ GB663R/GB664R/GB665R/GB668R/GB669R/GB670R... Drill attachment keyless Jacobs chuck GB620R... Attachments with three-jaw chuck GB621R/GB639R/GB667R Zimmer chuck with Hudson/Zimmer shaft GB176R... Harris chuck with AO large shaft GB184R and DIN chuck with AO large shaft XF457R... Adapter AO large to DHS/DCS step drill GB628R... Sagittal saw attachment GB660R... Drill attachment for Synthes radiolucent angle transmission GB645R... Insert and clamp Kirschner wire attachment GB641R... Function checks... Safe operation... Validated reprocessing procedure... General safety notes... General information... Reusable products... Preparations at the place of use... Preparation before cleaning...

3 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 7 7 8 8 8 8 8 8

en 7.6 7.7 7.8 7.8.1 7.8.2 7.9 7.10 7.11 7.12 8. 9. 10. 11. 12. 12.1 12.2 12.3 12.4 13.

Product-specific safety instructions for the reprocessing procedure... Manual cleaning with wipe disinfection... Automatic cleaning/disinfection with manual pre-cleaning . . Manual pre-cleaning with a brush... Mechanical alkaline cleaning and thermal disinfection... Inspection, maintenance and checks... Packaging... Steam sterilization... Storage... Maintenance... Troubleshooting list... Technical Service... Accessories/Spare parts... Technical data... Classification according to Regulation (EU) 2017/745... Performance data, information about standards... Operating mode... Ambient conditions... Disposal...

1.

About this document

1.1

Scope

1.2 8 9 10 10 11 11 11 11 11 11 12 13 13 13 13 13 15 15 15

These instructions for use apply to the products listed below: Art. no.

Designation

GB176R

Zimmer chuck with Hudson/Zimmer shaft

GB184R

Harris chuck with AO large shaft

GB620R

Warnings

Warnings indicate risks to patients, users, and/or the product that could develop while using the product. Warnings are marked as follows: DANGER Indicates a potential danger. If it is not prevented, death or severe injuries may result. WARNING Indicates a potential danger. Minor or moderate injuries may result if this is not prevented. CAUTION Indicates a potential damage to property. The product may become damaged if it is not prevented.

2.

General information

2.1

Intended use

Task/Function When combined with the appropriate attachment and tool, the drill and reamer unit GA330, GA671 and GA672 are used to work on hard tissue, cartilage and related materials, as well as bone replacement materials, to screw bone pins in and out, and also set K-wires. 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 0 rpm to max. 250 rpm

Drill attachment keyless Jacobs chuck

GB667R GB668R GB669R GB670R

GB621R

Drill attachment large Jacobs chuck

GB657R

0 rpm to max. 370 rpm

GB623R

Drill attachment AO small

GB645R

0 rpm to max. 900 rpm

GB628R

Adapter AO large to DHS/DCS step drill

0 rpm to max. 1 000 rpm

GB639R

Drill attachment small Jacobs chuck

GB641R

Kirschner wire attachment

GB645R

Drill attachment for Synthes radiolucent miter gear

GB620R GB621R GB663R GB664R GB665R

GB657R

Medullary reamer attachment AO large

0 rpm to max. 1 250 rpm

GB660R

Sagittal saw attachment

GB623R GB639R GB641R

GB663R

Drill attachment Trinkle

GB660R

0 rpm to max. 17 000 rpm

GB664R

Drill attachment Aesculap hexagonal

GB665R

Drill attachment Hudson/Zimmer

GB667R

Milling attachment large Jacobs chuck

GB668R

Milling attachment AO large

GB669R

Reamer attachment Hudson/Zimmer

GB670R

Reamer attachment Harris

XF457R

DIN chuck with AO large shaft

► For instructions for use of specific items and information on material

compatibility, see B. Braun eIFU at eifu.bbraun.com

Speed

Direction of rotation

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) Clockwise/counterclockwise rotation ■ 60 second application, 60 second pause ■ 20 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C

3

en Reaming (clockwise/counterclockwise rotation) ■ 30 second application, 30 second pause ■ 8 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Drilling (oscillation)

■ 60 second application, 60 second pause ■ 4 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw operation using GB660R

■ 30 second application, 60 second pause ■ 3 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

Type and area of application depend on the selected tool.

2.4

Absolute contraindications

The product is not approved for use in the central nervous system or central circulatory system.

2.5

Relative contraindications

The safe and effective use of the product depends greatly on factors that only operators themselves can control. The information provided therefore only represents general conditions. The clinically successful use of the product depends on the knowledge and experience of the surgeon. They must decide which structures can be sensibly treated and must take the safety information and warnings in the instruction for use into account.

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

■ General risks of surgical intervention are not described in these instructions for use.

■ The·surgeon·is·responsible·for·the·proper·execution of the surgical intervention.

■ The surgeon must be proficient in both the practical and theoretical aspects of the recognized surgical techniques.

4

► 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 to not compromise the manufacturer warranty and liability: – Use product only in accordance with these instructions for use. – Observe safety information and maintenance instructions. – Only Aesculap products may be combined 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 instructions for use accessible to the user. ► Always adhere to applicable standards. ► Ensure that the electrical installation of the room fulfills the requirements of IEC/DIN EN. ► Do not operate the product in explosion-hazard areas. ► Sterilize product before use. ► When using ECCOS holder systems, observe relevant instructions for use TA009721, see B. Braun eIFU at eifu.bbraun.com Note The user must report all serious incidents occurring in connection with the product to the manufacturer and to the competent authority of the country in which the user is registered.

4.

Product description

4.1

Scope of supply

Art. no.

Designation

GB176R GB184R GB620R GB621R GB623R GB628R GB639R GB641R GB645R GB657R GB660R GB663R GB664R GB665R GB667R GB668R GB669R GB670R XF457R

One of the following attachments/adapters: Zimmer chuck with Hudson/Zimmer shaft Harris chuck with AO large shaft Drill attachment keyless Jacobs chuck Drill attachment large Jacobs chuck Drill attachment AO small Adapter AO large to DHS/DCS step drill Drill attachment small Jacobs chuck Kirschner wire attachment Drill attachment for Synthes radiolucent miter gear Medullary reamer attachment AO large Sagittal saw attachment Drill attachment Trinkle Drill attachment Aesculap hexagon Drill attachment Hudson/Zimmer Milling attachment large Jacobs chuck Reamer attachment AO large Reamer attachment Hudson/Zimmer Reamer attachment Harris DIN chuck with AO large shaft

GA031R

Chuck key for large Jacobs chuck (GB620R, GB621R and GB667R)

GA062R

Chuck key for small three-jaw chuck (GB639)

TA014541

Instructions for use for Acculan 4 attachments (flyer)

en 4.2

Components required for operation

■ Drill and reamer GA330 (ready)

– or ■ Acculan 3Ti drill and milling machine GA672 (ready for operation) – or ■ Acculan 3Ti Small drill GA671 (ready for operation) ■ Tool (depending on indication)

4.3

Operating principle

The attachment can be coupled to the drill and reamer in three different positions, each offset by 120°. The attachment locks automatically when attached to the drill and reamer. The attachment can be removed by operating a rotating sleeve on the drill and reamer. The attachments have various integrated couplings on the working end, to enable attachment of various tools, with adapter if necessary.

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 inappropriate use of tools! ► Always follow the safety advice and information given in the instructions for use. ► Handle tools with cutting edges with care when coupling/uncoupling.

6.1

System set-up

6.1.1

Connecting the accessories

Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. All configurations must fulfill the fundamental standard IEC/DIN EN 60601-1. The person connecting the devices with each other is responsible for the configuration and must ensure that the fundamental standard IEC/DIN EN 60601-1 or relevant national standards. ► Follow the instructions for use of individual accessories. ► In case of questions, contact your B. Braun/Aesculap partner or Aesculap Technical Service, address see Technical Service.

6.2

Protection against inadvertent activation

The rotational speed control button can be locked to prevent inadvertent activation of the drill and reamer during a tool/attachment change. 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 further information on the drill and reamer, see TA014538 or TA014539 (flyer).

6.3

Coupling and uncoupling of attachment to drill and reamer

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 and reamer 1 against inadvertent activation with the

safety catch 3, see Protection against inadvertent activation. Coupling ► Push the attachment onto drill and reamer 1 until it engages with a

WARNING The product can be damaged by dropping! ► Use the products only if they are in perfect technical condition, see Function check 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.

click. ► Pull at attachment to check that it is securely coupled.

Uncoupling ► Turn the sleeve 4 in the direction of the arrow 5 and simultaneously remove the attachment from the drill and reamer 1.

6.4

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.

5

en 6.4.1

Attachments with quick-action chuck GB623R/GB657R/ GB663R/GB664R/GB665R/GB668R/GB669R/GB670R

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 6/9. ► Release the unlocking sleeve 7. Tool is attached. ► Pull at tool to check that it is securely coupled. Uncoupling ► Pull back the unlocking sleeve 7. ► Remove tool.

6.4.5

Harris chuck with AO large shaft GB184R and DIN chuck with AO large shaft XF457R

Coupling ► Push unlocking sleeve back 15 and hold. ► Insert the tool shaft in the correct position up to the st op in the tool holder 8 of the attachment 14. ► Release the unlocking sleeve 15. ► Pull at tool to check that it is securely coupled. Uncoupling ► Push unlocking sleeve back 15 and hold. ► Remove tool. 6.4.6

Adapter AO large to DHS/DCS step drill GB628R

6.4.2 Drill attachment keyless Jacobs chuck GB620R Note The drill attachment keyless Jacobs chuck GB620R may open during lefthand rotation of tools (e.g. when pulling out tools). To operate tools in left-hand rotation, use the Jacobs chuck with key GB621R, GB639R or GB667R.

Coupling ► Push unlocking sleeve back 15 and hold. ► Insert the tool shaft in the correct position up to the st op in the tool holder 8 of the attachment 16. ► Release the unlocking sleeve 15. ► Pull at tool to check that it is securely coupled.

Note If necessary, the key GA031R can be used for coupling and decoupling.

Uncoupling ► Push unlocking sleeve back 15 and hold. ► Remove tool.

Coupling ► Rotate the locking sleeve 11 clockwise and open Jacobs chuck. ► Insert the tool shaft in the correct position up to the st op in the tool

holder 8 of the attachment 10. ► Rotate locking sleeve 11 counterclockwise and close Jacobs chuck. ► Pull at tool to check that it is securely coupled. Uncoupling ► Rotate the locking sleeve 11 clockwise and open Jacobs chuck.

6.4.7

Sagittal saw attachment GB660R

Coupling ► Insert saw blade 25 into the slot of the tool holder 18, see Fig. A. Ensure that the side stops of the saw blade are aligned with the tool holder. The tool engages. ► Pull on the attachment 22 to ensure a secure fit.

► Remove tool.

Uncoupling

► Rotate the locking sleeve 11 counterclockwise and close Jacobs chuck.

► Press kjnob for tool release 19 and pull saw blade 25 out of the tool

6.4.3

Attachments with three-jaw chuck GB621R/GB639R/GB667R

Coupling ► Open the Jacobs chuck with the key 13. ► Insert the tool shaft in the correct position up to the st op in the tool

holder 8 of the attachment 12. ► Close the Jacobs chuck with the key 13 and pull tight. ► Pull at tool to check that it is securely coupled.

Uncoupling ► Open the Jacobs chuck with the key 13. ► Remove tool.

6.4.4

Zimmer chuck with Hudson/Zimmer shaft GB176R

holder 18. 6.4.8

Drill attachment for Synthes radiolucent angle transmission GB645R 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. Coupling the angle transmission ► Push the radiolucent angle transmission up to the stop on holder 8 of the drill attachment 20. ► If necessary, slightly move the radiolucent unit.

Coupling ► Push unlocking sleeve forward 15 and hold. ► Insert the tool shaft in the correct position up to the st op in the tool holder 8 of the attachment 14. ► Release the unlocking sleeve 15. ► Pull at tool to check that it is securely coupled.

Decouple angled handpiece ► Forcefully pull out the radiolucent angle transmission from the drill attachment 20.

Uncoupling

6.4.9

► Push unlocking sleeve forward 15 and hold. ► Remove tool.

6

Couple/decouple the tool ► Follow the instructions for the radiolucent angle transmission 511.300

in the operating instructions of the Synthes company. Insert and clamp Kirschner wire attachment GB641R

WARNING Risk of injury when using long guide wires! ► Use Kirschner wire protection sleeve when using long guide wires.

en 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. For further information see TA014535 or TA014539 (flyer). The following diameters can be set on the Kirschner wire attachment: ■ 0.6 mm to 1.8 mm ■ 1.8 mm to 3.0 mm ■ 3.0 mm to 4.0 mm Insert Kirschner wire ► Ensure that the clamping lever 22 is in the starting position (deacti-

vated status). ► Set the adjusting sleeve 23 of the Kirschner wire attachment to the

desired diameter range: – Push back the adjusting sleeve 23 and turn until the desired diameter range has been reached. – Release adjustment sleeve 23, making certain that adjustment sleeve 23 clicks into position. ► Insert the Kirschner wire into the Kirschner wire chuck 24 until the desired exposed length is achieved. The Kirschner wire is held in the intended position in the attachment by an automatic clamping mechanism. Clamping the Kirschner wire ► Pull on the clamping lever 22 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.

6.5

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. ► Ensure that the tool blades are not mechanically damaged. ► Release drill and reamer for use (ON position). ► Briefly run the drill and reamer at maximum speed in clockwise and counterclockwise mode. ► Make certain that the rotational direction is correct in each case. ► 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.

6.6

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 reamer tools such as the acetabulum reamer and the medullary reamer. ► Operate any reamer tool only with a reamer attachment. ► 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 tool may get caught in cover sheets (e.g. textiles). ► Do not let the tool come into contact with drapes (such as textiles) during operation. WARNING Risk of injury through inadvertent release of the saw blade! ► Do not press the tool unlock button when in use. ► Check for secure fixation of the tool after any tool change. Operating the product Note For further information on the drill and reamer, see TA014538 or TA014539 (flyer). ► Start the drill and reamer at 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

torque setting. Use the following attachments for drilling: ■ GB620R ■ GB621R ■ GB623R ■ GB639R ■ GB663R ■ GB664R ■ GB665R Use the following attachments for milling (medullary reaming): ■ GB667R ■ GB668R ■ GB669R ■ GB670R Use the following attachment for medullary reaming: ■ GB657R Use the following attachment for the placement of Kirschner wires: ■ GB641R Use only the following attachment for using the radiolucent angle transmission 511.300 from the Synthes company: ■ GB645R Use the following attachment for drilling: ■ GB660R

7

en 7.

Validated reprocessing procedure

7.1

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. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note See also B.Braun eIFU at eifu.bbraun.com for current information on processing and compatibility of material 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: ■ 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 ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org link to "AKIBrochures", "Red brochure".

8

7.3

Reusable products

The service life of the product is limited by damage, normal wear, type and duration of the application, handling, storage and transportation of the product. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

7.4

Preparations at the place of use

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

ries). ► Remove the attachment from drill and reamer. ► 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.

7.5

Preparation before cleaning

► Prior to first mechanical cleaning/disinfection process: Install ECCOS

holders in suitable basket. ► Insert the products in the correct position into the ECCOS holders, see

Fig. B. Kirschner wire attachment GB641R ► Turn adjustment sleeve 20 to setting for largest Kirschner wire diameter.

7.6

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 agents and disinfectants in accordance with the manufacturer's instructions, – which have been approved for plastics and stainless 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 7.7

Manual cleaning with wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water qual- Chemicals ity

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 de-ionized water (de-mineralized, microbiological, with minimum quality of drinking water) Room temperature Suitable enzyme solution: Helizyme, Cidezyme (the latter for validation purposes)

► 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 ► Mobilize non-rigid components during cleaning. ► Clean the product under running water, using a suitable cleaning brush

until all visible residues have been removed from the surfaces.

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

► Brush difficult to access surfaces with a suitable plastic cleaning brush

for at least 1 min. 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. ► Contamination should be removed with a lint-free cloth or soft brush

moistened with enzyme cleaner. ► Flexible components 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 com-

ponents for residues. Phase III ► Mobilize non-rigid components during cleaning. ► Rinse product under running tap water for at least 5 minutes. ► 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 7.8

Automatic cleaning/disinfection with manual precleaning

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. 7.8.1

Manual pre-cleaning with a brush

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry/Note

I

Rinse

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 GB641R: Set the adjustment sleeve 20 to the greatest Kirschner wire diameter. Phase I ► Mobilize non-rigid components during cleaning. ► Thoroughly clean the product under running water.

Phase II ► Mobilize non-rigid components during cleaning. ► Brush cannulation with cleaning brush TA011944 and difficult to

access surfaces with a suitable cleaning brush made of plastic 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 on Aesculap Extranet at https://extranet.bbraun.com).

10

en 7.8.2 Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water qual- Chemical ity

I

Pre-rinse

<25/77

3

D–W

–

II

Cleaning

55/131

10

DI-W

■ Concentrate, alkaline: – pH ~ 13 – <5 % anionic surfactant

■ ready-to-use solution 0.5 % – pH ~ 11* III

Intermediate rinse

>10/50

1

FD–W

–

IV

Thermal disinfection

90/194

5

FD–W

–

V

Drying

max. 120/248

min. 10min

–

–

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

► For Kirschner wire attachment GB641R: Set the adjustment sleeve 20

7.11 Steam sterilization

to the greatest Kirschner wire diameter. ► Insert the product in its correct position in the ECCOS holder. ► Then connect the interior rinse device to the ECCOS holder and connect it 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.

Note Remove all attached components from the product (tools, accessories) before sterilization.

7.9

Inspection, maintenance and checks

► Allow the product to cool down to room temperature. ► Spray product after every cleaning and disinfection with Acculan 4 oil

spray adapter 23 GB600840 (black) for approx. 2 sec. with STERILIT Power Systems oil spray GB600, see Fig. C. Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, connections) with STERILIT Power Systems oil spray.

► Check to ensure that the sterilizing agent can 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 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.

► Inspect the product after each cleaning and disinfecting cycle to be

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

7.10 Packaging ► Follow the instructions for use of the packagings and holders used

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

7.12 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. Contact your national B. Braun/Aesculap representative for these services, see Technical Service.

11

en 9.

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). Preventive measure: 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 counterclock- Use serrated tools only in clockwise mode wise mode

Attachment defective

Attachment very hot

Follow operating instructions (preparation, care). Preventive measure: 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.

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.

Insufficient power

Coupling on drill deformed/defec- Attachment is difficult to couple tive or cannot be coupled

Have the manufacturer repair the drill.

Sleeve on drill hard to move

Attachment does not 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 GB641R: Kirschner wire cannot be inserted 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 GB641R: 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.

Tool does not attach or detach.

12

en Issue

Cause

Detection

Remedy

Tool not moving

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

Correctly attach the tool and perform a function test.

Attachment defective

Drill turning, but attachment is not turning.

Have the manufacturer repair the attachment.

Drill tool broken

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.

Oil spray adapter not compatible

Oil spray adapter not attachable

Use the compatible oil spray adapter for GA344.

Oil spray adapter not attachable

10. Technical Service

12. Technical data

DANGER Danger to life of patients and users in case of malfunctions and/or failure of protective measures! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient.

12.1 Classification according to Regulation (EU) 2017/745

CAUTION Modifications of medical devices may result in a loss of potential guarantee/warranty claims and forfeiture of applicable licenses. ► Do not modify the product. ► Contact national B. Braun/Aesculap representative for service and repair. 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.

11. Accessories/Spare parts

Art. no.

Name

Class

GB176R GB184R GB620R GB621R GB623R GB628R GB639R GB641R GB645R

Zimmer chuck with Hudson/Zimmer shaft Harris chuck with AO large shaft Drill attachment keyless Jacobs chuck Drill attachment large Jacobs chuck Drill attachment AO small Adapter AO large to DHS/DCS step drill Drill attachment small Jacobs chuck Kirschner wire attachment Drill attachment for Synthes radiolucent angle transmission Medullary reamer attachment AO large Sagittal saw attachment Drill attachment Trinkle Drill attachment Aesculap hexagonal Drill attachment Hudson/Zimmer Reamer attachment large Jacobs chuck Milling attachment AO large Reamer attachment Hudson/Zimmer Reamer attachment Harris DIN chuck with AO large shaft

IIa

GB657R GB660R GB663R GB664R GB665R GB667R GB668R GB669R GB670R XF457R

Art. no.

Name

12.2 Performance data, information about standards

GB243R

ECCOS set for 2 large machines

Rotational direction

Right and left rotation, oscillation

GB600

STERILIT Power Systems oil spray

IEC/EN 60601-1

GB600840

Oil spray adapter

Conforming to standard

TA011944

Cleaning brush

GB496R

ECCOS fixation for 3 attachments

GB497R

ECCOS fixation for one attachment

GA031R

Key for large three-jaw chuck

GA062R

Chuck key for small three-jaw chuck

TA014541

Instructions for use for Acculan 4 attachments (flyer)

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 [rpm], approx.

Max. Torque [Nm], approx.

Cannulation [mm]

GB620R

Jacobs chuck keyless Ø 0.3 mm to 7.4 mm

133 x 35

397

1 000

5

4

GB621R

Jacobs chuck with key Ø 0.5 mm to 7.4 mm

118 x 35

300

1 000

5

4

GB623R

AO small

90 x 35

210

1 250

4

2.8

GB639R

Small three-jaw chuck with key Ø 0.5 mm to 4.0 mm

105 x 35

243

1 250

4

4

GB645R

Synthes radiolucent angle transmission

110 x 35

225

900

5

–

GB663R

Trinkle

93 x 35

217

1 000

5

4

GB664R

Aesculap hex

86 x 35

225

1 000

5

4

GB665R

Hudson/Zimmer

100 x 35

230

1 000

5

4

Milling attachments Attachment

Connector

Dimensions Length x ∅ [mm] ±5 %

Weight [g] ±10 %

Max. Speed [rpm], approx.

Max. Torque [Nm], approx.

Cannulation [mm]

GB657R

AO large

108 x 35

300

370

12

4

GB667R

Jacobs chuck with key Ø 0.5 mm to 7.4 mm

133 x 35

280

250

19

4

GB668R

AO large

108 x 35

300

250

19

4

GB669R

Hudson/Zimmer

118 x 35

300

250

19

4

GB670R

Harris

106 x 35

290

250

19

4

Saw Attachments Attachment

Connector

Dimensions L x W x H [mm] ± 5 %

Weight [g] ±10 %

Max. Oscillation frequency

Cannulation [mm]

GB660R

Rapid Action

89 x 36 x 44

270

17 000

–

Kirschner wire attachment Attachment

Connector

Dimensions L x W x H [mm] ±5 %

Weight [g] ±10 %

Max. Speed [rpm], approx.

Cannulation [mm]

GB641R

Kirschner wire ∅ 0.6mm to 4mm

93 x 36 x 137

285

1 250

4

Adapter Attachment

Connector

Dimensions Length x ∅ [mm] ±5 %

Weight [g] ±10 %

Max. Speed [rpm], approx.

Max. Torque [Nm], approx.

Cannulation [mm]

GB184R

Harris

88 x 22

85

Using GB668R: 250 With GB657R: 370

Using GB668R: 19 Using GB657R: 12

–

GB176R

Zimmer

50 x 22

55

Using GB669R: 250 With GB665R: 1 000

Using GB669R: 19 With GB665R: 5

3

GB628R

DHS/DCS

61 x 22

70

Using GB668R: 250 With GB657R: 370

Using GB668R: 19 Using GB657R: 12

4

XF457R

DIN

75 x 25

100

With GB668R: 250 Using GB657R: 370

Using GB668R: 19 With GB657R: 12

–

14

en 12.3 Operating mode Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1) clockwise/counterclockwise rotation ■ 60 second application, 60 second pause ■ 20 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Reaming (clockwise/counterclockwise rotation)

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

■ 60 second application, 60 second pause ■ 4 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw operation using GB660R

■ 30 second application, 60 second pause ■ 3 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C 12.4 Ambient conditions Operation

Transport and storage

10 °C to 27 °C

-10 °C to 50 °C

Relative humid- 30 % to 75 % ity

10 % to 90 %

Atmospheric pressure

500 hPa to 1 060 hPa

Temperature

700 hPa to 1 060 hPa

13. Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packagings. Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. ► Detailed information concerning the disposal of the product is avail-

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

15