ELAN 4 electro drill GA844

15

A

B

1

en

Aesculap® ELAN 4 electro drill GA844 Legend

Atmospheric pressure limits during transport and storage

1 Product (ELAN 4 electro drill) 2 Rotational speed control button 3 Safety catch 4 Screw handle 5 Cable 6 Connector for control unit 7 Knob for left-rotation 8 Coupling 9 Arrow 10 Rotating sleeve 11 Adapter (for Kirschner wire protection sleeve and rinsing adapter) 12 Kirschner wire protection sleeve 13 Attachment 14 Rinsing adapter 15 Oil spray adapter 16 Symbol of the application part type in the display of the ELAN 4 electro control unit

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

Observe the instructions for use

Labelling of electrical and electronic devices according to the directive 2002/96/EG (WEEE) Classification Type BF

Reverse button clockwise/counterclockwise rotation + oscillation mode switch

Symbols on product and packages Caution Observe important safety information such as warnings and precautions in the instructions for use.

YYYY-MM

Maintenance indicator Indication of the next recommended maintenance date (date: year-month) at the international B. Braun/Aesculap agency, see Technical Service Machine-readable, two-dimensional code The code contains a unique serial number that can be used for electronically tracking individual instruments. The serial number is based on the worldwide standard sGTIN (GS1). Manufacturer

Date of manufacture

Non-sterile medical device

Manufacturer’s batch name Manufacturer’s serial number Manufacturer’s article number Temperature limits during transport and storage

Air humidity limits during transport and storage

2

Speed control

Contents 1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 2.5 2.6 3. 4. 4.1 4.2 4.3 5. 6. 6.1 6.2 6.3

About this document... Scope... Warnings... General information... Intended use... Main functions and design characteristics... Application environment... 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... Function checks... Safe operation...

3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 5 5 6 6

en 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 8. 9. 10. 11. 12. 12.1 12.2 12.3 12.4 13.

Validated reprocessing procedure... General safety notes... General information... Reusable products... Preparations at the place of use... Preparation before cleaning... Cleaning/disinfection... Manual cleaning with wipe disinfection... Automatic cleaning/disinfection with manual pre-cleaning . . Inspection, maintenance and checks... Packaging... Steam sterilization... Storage... Maintenance... Troubleshooting list... Technical Service... Accessories/Spare parts... Technical data... Classification in accordance with Regulation (EC) 2017/745. . Performance data, information about standards... Short-time interval operation... Ambient conditions... Disposal...

1.

About this document

1.1

Scope

7 7 7 7 7 7 7 8 9 10 10 10 10 10 10 10 10 11 11 11 11 11 11

These instructions for use apply to the ELAN 4 electro drill tool GA844. ► For article-specific instructions for use and material compatibility information, see B. Braun eIFUs at eifu.bbraun.com

1.2

Warnings

Warnings indicate risks to patients, users, and/or products which may develop during the use of 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. If it is not prevented, minor or moderate injuries may result. CAUTION Indicates a potential damage to property. If it is not prevented, the product may be damaged.

2.

General information

2.1

Intended use

The ELAN 4 electro drill GA844 is an accessory of the ELAN 4 electro motor system. The drill is connected to the control unit. The ELAN 4 electro drill tool GA844, combined with the corresponding attachment and tool, is used for processing hard tissue, cartilage and similar as well as bone subsitute materials, to screw bone pins/bone screws in and out and to set Kirschner wires.

2.2

Main functions and design characteristics

Speed min. 0 min-1 to max. 1 250 min-1 Rotational direction Right and left rotation, oscillation Short-time interval operation Drilling (clockwise/counterclockwise rotation): ■ 60 second application, 60 second pause ■ 6 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Medullary reaming (clockwise/anti-clockwise rotation): ■ 30 second application, 30 second pause ■ 8 repetitions ■ 30 min cooling time ■ Max. temperature 48 °C Drilling (oscillation): ■ 15 s application, 15 s pause ■ 3 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw operation with GB891R: ■ 30 second application, 60 second pause ■ 4 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw operation with GB892R: ■ 30 second application, 60 second pause ■ 5 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Screws with GB896R and GB897R: ■ 10 s machine application, 10 s manual application, 30 s pause ■ 30 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Electrical systems generally heat up during continual operation. It is advisable to give the system a break after use to cool down, as indicated below. Heating depends on the tool used and the load. After a certain number of repetitions, the system should cool down. This procedure prevents 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

Application environment

Use in sterile and non-sterile areas Sterile separation at the control unit. 3

en 2.4

Indications

The type and area of application depend on the tools selected.

2.5

Absolute contraindications

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

2.6

Relative contraindications

The safe and effective use of the products greatly depends on influences which can only be controlled by the user. Therefore the specifications provided represent framework conditions only. The clinically successful use of the product is dependent on the knowledge and experience of the surgeon. The surgeon must decide on which bodily structures to use the product 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. WARNING Risk of injury and damage to property due to improper handling of the product! This product is an accessory of the ELAN 4 electro control unit GA800. ► Observe the instructions for use of the ELAN 4 electro control unit GA800 (TA014401). ► Follow the instructions for use of all products used.

■ General risk factors associated with surgical procedures are not 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. ► Observe the relevant instructions for use TA009721 when handling the Aesculap holder systems, see B. Braun eIFU under eifu.bbraun.com Note The user is obligated to 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

4.

Product description

4.1

Scope of supply

Art. no.

Designation

GA844

ELAN 4 electro drill

GA344244

Kirschner wire protection sleeve

GA344211

Rinsing adapter

GB600880

Oil spray adapter for GA344/GA844

TA011944

Cleaning brush

TA014437

Instructions for use for GA844 (leaflet)

4.2

Components required for operation

■ Operationally ready ELAN 4 electro control unit GA800, see TA014401 (from software: V3.00) ■ Attachment (depending on the indication, see also instructions for use TA014552 or TA014553) ■ Tool (depending on indication)

4.3

Operating principle

The product 1 has an electric motor which is connected to the ELAN 4 control unit and supplied with voltage by means of a permanently connected cable 5. The output speed is controlled electronically and can be continuously regulated with the knob for speed control 2. The direction of rotation can be changed from right to left again using the knob for left rotation 7. The product can also be operated in an oscillation mode. On the output side, the product 1 has a coupling 8, which enables the coupling of various drilling, medullary reamers, sawing, and screw attachments. These attachments lock themselves when plugging into the product. By actuating a rotating sleeve 10 the attachment 13 can be loosened. The gearing in the various attachments changes the tool speed and permits operation of the motor at an ideal operating point. The attachments have various integrated couplings on the working end, to receive corresponding tools, with adapters as applicable. The product is equipped with a cannulation to receive guide spears or the like.

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.

en 6.

Working with the device

WARNING Risk of infection and contamination! Product is delivered unsterilized! ► Sterilize the product before use according 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. 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. WARNING Damage to the product due to incorrect handling! ► Do not kink, jam, crush, and pull on the motor cable, also do not damage it using sharp objects.

6.1

System set-up

WARNING Risk of injury due to small parts that could enter the surgical field! ► Do not couple/uncouple tools and attachments over the surgical field. Connecting the accessories Do not use accessories in combinations that are not mentioned in these instructions for use. ► Follow the instructions for use of individual accessories. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service.

Protection against inadvertent activation Note The safety catch at the ELAN 4 electro drill tool GA844 is only used for mechanical protection against an unintentional actuation of the speed control pusher 2. When the safety catch is activated there is no communication with the control unit and it is not shown in the display. To prevent the product being inadvertently activated when changing a tool or accessory, the knob for speed control can be locked. To lock rotational speed control button 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. Attaching and removing product attachments Note For additional information on the attachments, see TA014552 and TA014553 (leaflet). 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 product 1 from inadvertent activation with the safety catch 3,

see Protection against inadvertent activation. Coupling ► Push attachment 13 into coupling 8 until it clicks into place. ► Pull on the attachment 13 to ensure a secure fit. Uncoupling ► Turn the sleeve 10 in the direction of the arrow 9 and simultaneously

remove the attachment 13 from the product 8. Attach the Kirschner wire protection sleeve Note The special Kirschner wire chuck is recommended for the placement of guide wires. WARNING Risk of injury when using long guide wires! ► Use Kirschner wire protection sleeve when using long guide wires. ► Screw on the Kirschner wire protection sleeve 12 into attachment 11.

Attach the tool to the attachment Note Attachment of the tools is described in operating instructions TA014552 and TA014553 (leaflet).

5

en 6.2

Function checks

A function check must be carried out prior to each use and attachment change. ► Check the secure connection of all products to be used. ► 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 product for use (ON position). ► Run the product shortly at maximum speed in right and left rotation. ► 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.

6.3

Safe operation

WARNING Coagulation of patient tissue or risk of burns for patients and user through hot product! ► Do not use products 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. The application part can only be operated and the insertion parameters can only be altered on the control unit when: ■ the application part is connected to the control unit, ■ there is no second application part activated (position "On”) at the same time and ■ the application part type 16 is shown in the display for the control unit. Note two ELAN 4 electro drill tools GA844 are connected to the ELAN 4 electro control unit GA800, the drill tool whose speed control button is actuated first is active.

6

Note For additional information, see the operating instructions for the ELAN 4 electro control unit GA800 (TA014401). Note The product drive motor is operated using a magnetic sensor system. In order to prevent inadvertent activation of the motor, the product may not be exposed to any magnetic fields (such as magnetic instrument pads). Normal Operation Product operating in right rotation mode: ► Activate the knob for speed control 2. The speed of the product 1 is continuously regulated pursuant to the attachment utilized. Product operating in left rotation mode: ► Press the knob for left rotation 7 completely in and keep it depressed. ► Activate the knob for speed control 2. The speed of the product 1 is continuously regulated pursuant to the attachment utilized. Oscillating operation or thread cutting operation Note Check that the oscillation mode is set to "ON" at the control panel on the ELAN 4 control unit (GA800). Enable oscillating operation or thread cutting operation: ► Keep the knob for left rotation 7 pressed for 3 seconds. There will be multiple signal tones. Oscillating operation: ► Press the knob for speed control 2 in all the way. Product 1 will rotate clockwise and counterclockwise in alternation. Tapping operation: ► Depress the speed control knob 2 up to a maximum of half-way. Product 1 will gradually turn counterclockwise and clockwise, whereby the rotational angle in the clockwise direction is greater than that of the counterclockwise direction. To activate left rotation: ► Press the speed control knob 2 in addition to the knob for left rotation 7. The product 1 will rotate counterclockwise. Disable oscillating operation or thread cutting operation: ► Keep the knob for left rotation 7 pressed for 3 seconds. There will be multiple signal tones.

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 eIFUs at eifu.bbraun.com for up-to-date information on processing and material compatibility 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. 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 damage to metallic products. 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, fracturing, premature aging, or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion ► For detailed information on hygienically safe and materialfriendly/careful processing, please refer to www.a-k-i.org Header "AKIBrochures", "Red brochure".

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 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: Install the ECCOS hold-

ers (GB482R/GB072R) in a suitable tray or use a pre-assembled tray GB262R. ► Place the product in the correct position in the ECCOS holder GB482R and arrange the cable around the ECCOS holders GB072R, see Fig. B.

7.6

Cleaning/disinfection

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 maximum temperature of 96 °C during thermal disinfection using DI 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.

7

en 7.7

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 using 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: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature * Suitable enzyme solution: Helizyme, Cidezyme (the latter used 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 ► Move flexible components (such as sleeves) 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 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. ► Remove contamination with a lint-free cloth or soft brush moistened

with enzyme cleaner. Phase III ► Move flexible components (such as sleeves) during cleaning. ► Rinse product under running tap water for at least 5 minutes. ► Rinse flexible components (such as sleeves) and cannulations 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. ► 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.

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). 8

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. Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

I

Rinse

II

Brushing

D–W: RT:

t [min]

Conc. [%]

Water quality

Chemistry/Note

RT (cold) -

-

D–W

until visually clean

RT (cold) -

-

D–W

until visually clean

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. Phase I ► Move flexible components (such as sleeves) during cleaning. ► Thoroughly clean the product under running water.

Phase II ► Move flexible components (such as sleeves) 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 pre-cleaning, check visible surfaces for residue and repeat the pre-cleaning process as required.

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

Step

T [°C/°F]

t [min]

Water quality

Chemical

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

max. 120/248

min. 10

-

-

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

► Place the product 1 in the correct position in the ECCOS holder

► Attach the Kirschner wire protection sleeve 12 to a rinse hose.

GB482R and arrange the cable around the ECCOS holders GB072R, see Fig. B. ► Attach the rinsing adapter 14 (GA344211) to the product 1 in the mount 11. ► Then connect the interior rinse device and connect to the rinse connector of the cleaning/disinfection device/rinse cart.

► After automatic cleaning/disinfection, check visible surfaces for resi-

dues and repeat the cleaning/disinfection process as needed.

9

en 7.9

Inspection, maintenance and checks

10. Technical Service

► Allow the product to cool down to room temperature. ► After every cleaning and disinfection, spray product with STERILIT

Power Systems oil spray GB600 using the oil spray adapter 15 GB600880 (green) for approx. 2 s, see Fig. A. Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, couplings) using the STERILIT Power Systems 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.

7.10 Packaging ► Follow the instructions for use of the respective packaging and holders

(e.g. instructions for use TA009721 for Aesculap ECCOS holder systems). ► Place the product in the correct position in the ECCOS holder GB482R and arrange the cable around the ECCOS holders GB072R, 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.

7.11 Steam sterilization Note Remove all attached components from the product (tools, accessories) before sterilization. ► Make certain that all external and internal surfaces of the product will

be exposed to the sterilizing agent. ► 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.

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 in accordance with the maintenance labeling or at least once a year.

YYYY-MM For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

9.

Troubleshooting list

Note For additional information, see the operating instructions for the ELAN 4 electro control unit GA800 (TA014401).

10

DANGER Risk of death to patients and users in case of malfunction 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. 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/Aesculaprepresentative 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.

Designation

GA344244

Kirschner wire protection sleeve

GA344211

Rinsing adapter

GB072R

ECCOS winding aid for cables and hoses

GB073R

ELAN 4 electro ECCOS motor cable

GB262R

ECCOS tray with fixations for GA844

GB600

STERILIT Power Systems oil spray

GB600880

Oil spray adapter for GA344/GA844

TA011944

Cleaning brush

GB482R

ECCOS holder for GA344/GA844

TA014401

Instructions for use for ELAN 4 electro control unit GA800 (A4 for ring-binder)

TA014436

Instructions for use for ELAN 4 electro drill tool GA844 (A4 for ring-binder)

TA014437

Instructions for use for ELAN 4 electro drill tool GA844 (leaflet)

TA014452

Instructions for use for attachments for the small drill tool GA344 and the drill tool GA844 (A4 for ring-binder)

TA014453

Instructions for use for attachments for the small drill tool GA344 and the drill tool GA844 (leaflet)

en 12. Technical data

Art. no.

Designation

Class

Screws with GB896R and GB897R: ■ 10 s machine application, 10 s manual application, 30 s pause ■ 30 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C

GA844

ELAN 4 electro drill tool

IIa

12.4 Ambient conditions

12.1 Classification in accordance with Regulation (EC) 2017/745

12.2 Performance data, information about standards Max. power

approx. 200 W

Speed

0 rpm to max. 1 250 rpm ±5 %

Direction of rotation

Clockwise and counter-clockwise rotation, oscillation

Cannulation

3.2 mm

Weight

0.8 kg ±10 %

Cable length

4 m ±10 %

Dimensions (L × W × H)

122 × 130 × 27 mm ±5 %

Application part

Type BF

EMC

IEC/EN 60601-1-2

Compliance with standards

IEC/EN 60601-1

After 350 preparatory cycles, the product was tested by the manufacturer and passed.

12.3 Short-time interval operation Drilling (clockwise/counterclockwise rotation): ■ 60 second application, 60 second pause ■ 6 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Medullary reaming (clockwise/anti-clockwise rotation): ■ 30 second application, 30 second pause ■ 8 repetitions ■ 30 min cooling time ■ Max. temperature 48 °C Drilling (oscillation): ■ 15 s application, 15 s pause ■ 3 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw operation with GB891R: ■ 30 second application, 60 second pause ■ 4 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw operation with GB892R: ■ 30 second application, 60 second pause ■ 5 repetitions ■ 30 min cooling time ■ Max. temperature 48 °C

Application part Operation

Transport and storage

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

13. Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packaging. Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. The recycling passport can be downloaded from the extranet as a PDF document for on the individual part number. (The recycling passport contains instructions on how to disassemble the device, including information on the proper disposal of environmentally harmful components.) Any product labeled with this symbol must be disposed of separately together with electrical and electronic equipment. Within the European Union, the manufacturer will perform the disposal free of charge. ► Detailed information concerning the disposal of the product is avail-

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

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