ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 ELAN 4elELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 ELAN 4electro HD handpiece (2 ring) GA865 to GA869ectro HD handpiece (2ring) GA865 to GA869

1

1

3

4

3

2

2

5

8

7 1

8

6 2

7 1 6 2

A

4

B

10

11 10 11

C

13 12

9 3

D

en

Aesculap® ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro HD handpiece (2 ring) GA865 to GA869 Legend

Manufacturer batch ID

1 2 3 4 5

ELAN 4 tool coupling (1 ring or 2 ring) Ring marking Connector for motor cable Slider for tool release Symbol of the applied part type in display of ELAN 4 electro control unit 6 ELAN 4 tool (1 ring or 2 ring) 7 ELAN 4 single-use spray nozzle for 1 ring or 2 ring handpieces 8 Tube connector on spray nozzle 9 Oil spray adapter GB600860 ELAN 4 ECCOS holder for 12 reamers GB718R 10 Side handles 11 Holding nibs 12 Tool coupling 13 Tab

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

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage According to US federal law, this product may only be sold by a physician or on the orders of a physician CE mark according to Regulation (EU) 2017/745

Symbols on product and packages

EAC symbol of the Eurasian Economic Union

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

YYYY-MM

Maintenance indicator Date of the next recommended servicing (year-month) by 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 sGTIN (GS1) standard. Manufacturer

Date of manufacture

Sterilization using irradiation Single sterile barrier system with inner protective packaging Non-sterile medical device

Not for reuse in intended applications as defined by the manufacturer Use by

Do not use if packaging is damaged

2

Medical device

Contents 1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 2.5 2.6 3. 3.1 3.2 4. 4.1 4.2 4.3 4.4 5. 6. 6.1 6.2 6.3

About this document... Scope... Warnings... General information... Intended use... Performance characteristics... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Sterile ELAN 4 tools... Sterile ELAN 4 single-use spray nozzles... Product description... Available sizes... Package includes... Components required for operation... Operating principle... Preparation... Working with the product... System set-up... Function check... Operation...

3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 5 5 5 5 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 7.13 8. 9. 10. 11. 12. 12.1 12.2 12.3 12.4 12.5 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 immersion disinfection - applied part . Mechanical cleaning/disinfecting with manual pre-cleaning applied part... Mechanical cleaning/disinfecting with manual pre-cleaning tools... Inspection, maintenance and checks... Packaging... Steam sterilization... Storage... Maintenance... Troubleshooting... Technical Service... Accessories/Spare parts... Technical Data... Classification in accordance with Regulation (EC) 2017/745. . Performance data, information about standards... Tool speed/Setting... Short interval operation... Ambient conditions... Disposal...

6 6 7 7 7 7 7 8

2.

General information

2.1

Intended use

9

2.2

10 11 11 11 11 12 12 12 12 13 13 13 13 13 13 13

The ELAN 4 electro standard handpiece (1-ring) GA861 to GA864 or ELAN 4 electro HD handpiece (2-ring) GA865 to GA869 is an accessory of the ELAN 4 electro motor system. The highspeed handpiece is connected by an ELAN 4 electro motor cable to the control unit. The handpiece is used to drive ELAN 4 tools (1-ring or 2-ring).

Performance characteristics

Speed min. 0 rpm to max. 80 000 rpm Direction of rotation Right and left rotation Short-time intermittent operation ■ 30 s application, 30 s pause ■ ∞ repetitions at 60 000 rpm ■ 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. Warming depends on the tool used and the load. After a certain number of repetitions, the system should be allowed to cool down. This procedure prevents the system from overheating and protects the patient or users against possible injury. The user shall be responsible for the implementation and adherence to the interval sequence described.

2.3

Application Environment

1.

About this document

Application in the sterile area

1.1

Scope

2.4

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

Designation

GA861–GA864

ELAN 4 electro Standard handpiece (1 ring)

GA865–GA869

ELAN 4 electro HD handpiece (2-ring)

► For article-specific instructions for use and material compatibility

information, see B. Braun eIFUs at eifu.bbraun.com

1.2

Warnings

Warnings indicate hazards to patients, users and/or products that may occur 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 not prevented, minor or moderate injuries may result.

Indications

Modes of application Separating, resecting and shaping hard tissue, cartilage, similar and bone substitute materials Surgical discipline/areas of application Neurosurgery, ENT surgery, OMF surgery, orthopedics and trauma surgery Note 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.

CAUTION Indicates a potential damage to property. If not prevented, the product may be damaged.

3

en 3.

Safe handling

WARNING If this product is not used as intended, injury and material damage may result! ► 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. ► Follow 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 installations at the premises where the device is to be used meet all requirements acc. to IEC/DIN EN. ► Do not use the control unit and applied part in potentially explosive areas. ► Sterilize application parts and motor cables 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 agrees 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.

Disposable products DANGER Reuse can cause infections in patients and/or users, and impairment of product functionality. Contamination and/or impaired function of the products may result in injury, illness and death! ► Do not reprocess the product.

3.2

Sterile ELAN 4 single-use spray nozzles

The spray nozzle is used to supply fluid for rinsing and cooling the tool or the place of application. DANGER Risk of infection for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product. The product is gamma-sterilized and supplied in sterile packaging. ► Do not reuse the product. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date.

4.

Product description

4.1

Available sizes

Note The shaft length can be seen on the shaft of the drill handpiece. ELAN 4 electro Standard handpiece (1 ring) Art. no.

Length of shaft

GA861

L4 (approx. 4 cm)

GA862

L7 (approx. 7 cm)

GA863

L10 (approx. 10 cm)

GA864

L13 (approx. 13 cm)

ELAN 4 electro HD handpiece (2 ring)

3.1

Sterile ELAN 4 tools

The product is gamma-sterilized and supplied in sterile packaging. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, observe and store the instructions for use for tools TA012787. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date. Note For further information, see instructions for use for tools TA012787.

4

Art. no.

Length of shaft

GA865

L7 (approx. 7 cm)

GA866

L10 (approx. 10 cm)

GA867

L13 (approx. 13 cm)

GA868

L17 (approx. 17 cm)

GA869

L22 (approx. 22 cm)

en 4.2

Package includes

ELAN 4 electro Standard handpiece (1 ring) Art. no.

Designation

GA861–GA864

ELAN 4 electro Standard handpiece (1-ring)

TA014443

Instructions for use for ELAN 4 electro Standard handpiece (1-ring) GA861 to GA864 / ELAN 4 electro HD handpiece (2-ring) GA865 to GA869 (leaflet)

ELAN 4 electro HD handpiece (2 ring) Art. no.

Designation

GA865–GA869

ELAN 4 electro HD handpiece (2-ring)

TA014443

Instructions for use for ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro HD handpiece (2 ring) GA865 to GA869 (leaflet)

4.3

Components required for operation

■ Operation-ready ELAN 4 electro control unit GA800, see TA014401 ■ ELAN 4 tool (1 ring or 2 ring) 4.4

Operating principle

The ELAN 4 electro handpiece 1-ring or 2-ring is equipped with ELAN 4 a tool coupling (1-ring or 2-ring). The 1-ring or 2-ring handpiece is used with ELAN 4 electro foot controls or manual controls. For the 1-ring or 2-ring handpiece, the clamped tool rotates at the set motor speed. The motor speed of the 1-ring or 2-ring handpiece is infinitely variable by means of the foot/manual control. The 1-ring or 2-ring handpiece can be operated both clockwise and anticlockwise.

6.

Working with the product

WARNING Risk of infection and contamination! Applied parts and motor cable are delivered unsterile! ► Carry out sterile processing of the applied parts and motor cable prior to use, in accordance with the instructions for use. WARNING Risk of injury and material damage due to inadvertent activation of the application part! ► Secure applied parts that are not actually used against inadvertent activation ("Off" position), see instructions for use for ELAN 4 electro control unit GA800 (TA014401). 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 Risk of burns to skin and tissue due to blunt tools/ lack of maintenance of the applied part! ► Use tools only if they are in perfect condition. ► Replace blunt tools. ► Ensure correct maintenance of the applied part, see Maintenance. WARNING Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check

6.1

System set-up

Note The ring marking 2 shows the shaft diameter of the tool to be used. ELAN 4 tools can be only coupled to the applied part if the ring markings (1 ring/2 ring) of the applied part and tool match.

WARNING Risk of injury when coupling/uncoupling tools in the "On" position due to accidental activation of the applied part! ► Only couple/uncouple tools in the "Off" position.

5.

WARNING Small parts entering the surgical field can cause injuries! ► Do not couple/uncouple tools over the operation site.

Preparation

If the rules listed below are not followed, Aesculap will not accept any responsibility. ► Do not use products from open or damaged sterile packaging. ► Prior to use, inspect the product and its accessories for visible damage. ► Use the products and their accessories only if they are in perfect technical condition.

Note Operating elements on the system components of the ELAN 4 electro motor system are labeled with a gold marking. 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. Remove the ELAN 4 ECCOS holder for 12 reamers GB718R from the tray The insert of the ELAN 4 ECCOS holder for 12 reamers GB718R can be removed from the tray in conjunction with the tools. ► Pull at the tab 13 and remove the insert from the holder, see Fig. C.

5

en Coupling the tool to the applied part ► Lock applied part ("Off" position), see instructions for use of ELAN 4 electro control unit GA800 (TA014401). ► Push tool shaft 6 as far as it will go into ELAN 4 tool coupling (1 ring or 2 ring) 1, see Fig. A. The tool engages. The tool is correctly coupled when the ring marking 2 on the tool is no longer visible. ► Pull at tool 6 to check that it is securely coupled. Uncoupling the tool from the applied part

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 catch cover drapes (textile or other). ► Never allow the tool to touch cover drapes (textile or other) during operation.

► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401). ► Pull back slider for tool release 4 on the applied part and remove tool 6 from ELAN 4 tool coupling (1 ring or 2 ring) 1, see Fig. A. Mounting the spray nozzle and tube set ► Connect tube set GA395SU to pump of ELAN 4 electro control unit GA800, see TA014401. ► Push the tube end directed at the area of application onto the tube connector of the ELAN 4 the disposable spray nozzle for the 1-ring or 2-ring handpiece 8. ► Push single-use spray nozzle for ELAN 4 1 ring or 2 ring handpieces 7 onto the shaft of the applied part and push/turn into the desired position, see Fig. A. Note The spray tube of the ELAN 4 single-use spray nozzle for 1 ring or 2 ring handpiece is bendable by hand and can be adapted to the requirements of application (e.g. aligned to tool head).

6.2

Function check

► Prior to each use, check that all products to be used are in good work-

ing order. ► Check the secure connection of all products to be used. ► Check that the tool is coupled properly. To do this, pull on the tool. ► Check that the cutting edges of the tools are not showing any mechan-

ical damage.

WARNING Danger of injury from foreign body reactions (e.g. inflammation, encapsulation) if particles remain in the body! When using diamond tools, it is always possible for diamond grains/nickel particles to break away/off. ► Carefully rinse and vacuum while and after working with diamond tools. It is only possible to operate the applied part and change the setting parameters on the control unit if: ■ the applied part is connected to the control unit, ■ there is no second applied part released ("On" position) at the same time and ■ the applied part type 5 is shown in the display of the control unit. Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

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.

► Briefly run the applied parts at maximum speed. ► Do not use the product if it is damaged or defective. Set aside the prod-

uct if it is damaged.

6.3

Operation

WARNING Coagulation of patient tissue or risk of burns for patients and users from hot application part/tool! ► Cool the tool during operation. ► Keep product/tool out of the reach of patients. ► Allow the applied part/tool to cool down. ► When changing the tool, use a cloth as a protection against burns. WARNING Risk of infection from aerosol formation! Risk of injuries caused by particles coming loose from the tool! ► Take appropriate protective measures, e.g. watertight protective clothing, face mask and protective goggles, suction extraction. WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

6

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.

en 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

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 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. Validated cleaning and disinfection procedure Product

Validated procedure

Reference

Application part

Manual cleaning with immersion disinfection

see Manual cleaning with immersion disinfection - applied part

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

see Mechanical cleaning/disinfecting with manual pre-cleaning applied part

Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

see Mechanical cleaning/disinfecting with manual pre-cleaning tools

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

Cleaning/disinfection

Preparations at the place of use

► Separate the products from each other immediately after use. ► 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

Tools

cleaning and disinfection within 6 hours.

7.5

Preparation before cleaning

Applied part ► Prior to first mechanical cleaning/disinfection: Mount ECCOS holder GB082R/GB083R in a suitable tray (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB082R/GB083R, see Fig. B. Tools ► Thoroughly rinse the product with running, cold water. ► Prior to first mechanical cleaning/disinfection: Mount the bottom part

of the ECCOS holder GB718R in a suitable tray (e.g. JF222R). ► Align the product in the correct position relative to the tool holder and

insert 12 into the ECCOS holder GB718R, see Fig. C. ► Engage the fixation in the bottom part. In doing so, make sure that the

holding lugs 11 on the insert are inserted in the recesses in the bottom part. ► Lift and fold down the tool holder 12 using the two side handles 10.

7

en 7.7

Manual cleaning with immersion disinfection - applied part

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Pre-cleaning

RT (cold)

-

-

D–W

–

II

Cleaning

RT (cold)

>5

1

D–W

pH-neutral, pH ~ 9*

III

Intermediate rinse

RT (cold)

-

-

D–W

-

IV

Disinfection

RT (cold)

>5

2

D–W

Concentrate-free, aldehyde-free, phenol-free, QUAT-free, pH ~ 9**

V

Final rinse

RT (cold)

-

-

D–W

-

VI

Drying

RT

-

-

-

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Helizyme **Recommended: BBraun Stabimed fresh

► Follow the instructions for use of the ELAN 4 rinsing devices and rins-

ing adapters TA014447 and TA014448. ► Do not clean the applied part in an ultrasound bath. Phase I ► Clean the product under running water, using a suitable cleaning brush

until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during cleaning. ► Rinse the applied part through the rinsing adapter GB698R at least

3 times for 5 seconds with a water gun. Phase II ► Using a disposable syringe, fill the inside of the applied part with clean-

ing solution through the rinsing adapter GB698R. ► Place the applied part, with rinsing adapter connected, fully in enzy-

matic cleaning solution for 5 minutes. Phase III ► Rinse the entire product (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during rinsing. ► Rinse the applied part through the rinsing adapter GB698R at least

3 times for 5 seconds with a water gun. Phase IV ► Prior to manual disinfection, allow rinsing water to drain off the prod-

uct for a sufficient length of time and use compressed air to blow all liquid out of the product through the rinsing adapter GB698R in order to prevent dilution of the disinfecting solution. ► Using a disposable syringe, fill the inside of the applied part with disinfectant solution through the rinsing adapter GB698R. ► Immerse the application part including the connected rinsing adapter at least 5 min in disinfecting solution. Phase V ► Rinse the entire product (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during cleaning. ► Rinse the applied part through the rinsing adapter GB698R at least

3 times for 5 seconds with a water gun.

8

Phase VI ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air). ► After manual cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

en 7.8

Mechanical cleaning/disinfecting with manual pre-cleaning - applied part

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals. Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Brushing

RT (cold)

–

–

D–W

-

II

Rinsing

RT (cold)

5

-

D–W

-

D–W: RT:

Drinking water Room temperature

► Follow the instructions for use of the ELAN 4 rinsing devices and rins-

ing adapters TA014447 and TA014448. ► Do not clean the applied part in an ultrasound bath. Phase I ► Clean the product with a suitable cleaning brush until all discernible

residues have been removed.

Phase II ► Connect the connector for motor cable 3 with ELAN 4 electro rinsing device GB692R. ► Rinse the applied part: – For 5 min with a tap/hose or – 3 times for 5 seconds with a water gun

► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during cleaning.

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

Step

T [°C/°F]

t [min]

Water quality

Chemicals

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, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Connect the connector for motor cable 3 with ELAN 4 electro rinsing

device GB692R. ► Place the rinsing device on a wire basket suitable for cleaning. ► Connect the rinsing device to the rinsing connection of the rinsing cart.

► After machine cleaning/disinfection process:

– Use a compressed air gun to remove any remaining rinsing water from the application parts and shafts, see the instructions for use ELAN 4 for rinsing device and rinsing adapter TA014447 or TA014448. – Visually check for residue on visible surfaces and repeat the cleaning/disinfection process if necessary. 9

en 7.9

Mechanical cleaning/disinfecting with manual pre-cleaning - tools

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals. Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Immersion

RT (cold)

>30

50

D–W

Enzymatic detergent*

II

Rinsing

RT (cold)

-

-

D–W

-

III

Ultrasonic cleaning

55/131

>15

2

D–W

Concentrate-free, aldehyde-free, phenol-free, QUATfree, pH ~ 9**

IV

Cleaning with brush

RT (cold)

-

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Helizyme **Recommended: BBraun Stabimed fresh

► Generally perform ultrasound cleaning solely in the ECCOS holder

GB718R to prevent any damage to the blades. Phase I ► Fully immerse the product in enzymatic cleaning solution for at least

30 minutes. Ensure that all accessible surfaces are moistened. Phase II ► Rinse the entire product (all accessible surfaces) under running water.

Phase III ► Fold up the handles 12 of the ECCOS tool holder GB718R on the

side 10, see Fig C. ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for

at least 15 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. Phase IV ► Clean the product with a suitable cleaning brush until all discernible

residues have been removed.

10

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

Step

T [°C/°F]

t [min]

Water quality

Chemicals

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, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Align the product in the correct position relative to the tool holder and

7.12 Steam sterilization

insert 12 into the ECCOS holder GB718R, see Fig. C. ► After machine cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

► Make sure that all external and internal surfaces of the product are

7.10 Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► Connect the ELAN 4 electro oil spray adapter GB600860 9 (grey) to the

connector for the motor cable 3 and use the STERILIT Power Systems oil spray GB600 to spray through the application part for approx. 2 s, see Fig. D. Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, couplings) using the Aesculap STERILIT Power Systems oil spray. ► Inspect the product after every cleaning and disinfecting cycle for:

exposed to the sterilizing agent. ► Validated sterilization process

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

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

a dry, dark, temperature-controlled area.

cleanliness, damage, function, abnormal operation noise, excessive heat or strong vibration. ► Inspect tools for broken, damaged or blunt edges. ► Set aside the product if it is damaged.

7.11 Packaging ► Observe the instructions for use of the packagings and holders used

(e.g. instructions for use TA009721 for Aesculap ECCOS holder system). ► Place the application part in the correct position in the ECCOS holder

GB082RGB083R, see Fig. B. ► Insert the tools in the correct position in the ECCOS holder GB718R, see

Fig. C. ► Pack trays appropriately for the intended sterilization process (e.g. in

Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the prod-

uct.

11

en 8.

Maintenance

Application part To ensure reliable operation, the product must be maintained in accordance with the maintenance labeling or at least once a year.

11. Accessories/Spare parts Art. no.

Designation

GA261SU

ELAN 4 single-use spray nozzle for 1 ring handpiece L4

GA262SU

ELAN 4 single-use spray nozzle for 1 ring handpiece L7

GA263SU

ELAN 4 single-use spray nozzle for 1 ring handpiece L10

GA264SU

ELAN 4 single-use spray nozzle for 1 ring handpiece L13

GA265SU

ELAN 4 single-use spray nozzle for 2 ring handpiece L7

GA266SU

ELAN 4 single-use spray nozzle for 2 ring handpiece L10

GA267SU

ELAN 4 single-use spray nozzle for 2 ring handpiece L13

GA268SU

ELAN 4 single-use spray nozzle for 2 ring handpiece L17

GA269SU

ELAN 4 single-use spray nozzle for 2 ring handpiece L22

GA395SU

ELAN 4 electro single-use tube set

GB082R

ELAN 4 electro ECCOS holder for reamer handpiece GA861 to GA869, 1 handpiece

10. Technical Service

GB083R

ELAN 4 electro ECCOS holder for reamer handpiece GA861 to GA869, 3 handpieces

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.

GB600

STERILIT Power Systems oil spray

GB600860

ELAN 4 electro oil spray adapter

GB692R

ELAN 4 electro rinsing device

GB698R

ELAN 4 electro rinsing adapter

CAUTION Modifications to medical equipment may result in loss of guarantee/warranty claims and any approvals. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap representative.

GB718R

ELAN 4 ECCOS holder for 12 reamers

TA012787

Instructions for use for tools for Aesculap motor systems - disposable products/reusable products

TA014442

Instructions for use for ELAN 4 electro Standard handpiece (1-ring) GA861 to GA864 / ELAN 4 electro HD handpiece (2-ring) GA865 to GA869 (A4 for folder)

TA014443

Instructions for use for ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro HD handpiece (2 ring) GA865 to GA869 (leaflet)

e.g. 2016-07 For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service. Tools No maintenance required for tools. ► Do not modify, re-sharpen or repair tools.

9.

Troubleshooting

Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

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.

12

en 12. Technical Data

12.5 Ambient conditions

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

Application part

Art. no.

Designation

Class

GA861– GA864

ELAN 4 electro Standard handpiece (1-ring)

GA865– GA869

ELAN 4 electro HD handpiece (2 ring)

Operation

Transport and storage

Temperature

10 °C to 27 °C

-10 °C to 50 °C

IIa

Relative humidity

30 % to 75 %

10 % to 90 %

Atmospheric pressure

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

IIa

12.2 Performance data, information about standards Max. power

approx. 140 W

Max. torque

approx. 2.2 Ncm

Max. motor speed

80 000 rpm

Tool connector

ELAN 4 1 ring (GA861 to GA864) ELAN 4 2 ring (GA865 to GA869)

Application part

Type BF

EMC

IEC/DIN EN 60601-1-2

Compliance with stan- IEC/DIN EN 60601-1 dards Art. no.

Weight

Dimensions (∅ x L)

GA861

80 g ±10 %

16 mm x 152 mm ±5 %

GA862

83 g ±10 %

16 mm x 177 mm ±5 %

GA863

87 g ±10 %

16 mm x 206 mm ±5 %

GA864

91 g ±10 %

16 mm x 237 mm ±5 %

GA865

89 g ±10 %

16 mm x 176 mm ±5 %

GA866

95 g ±10 %

16 mm x 206 mm ±5 %

GA867

100 g ±10 %

16 mm x 236 mm ±5 %

GA868

108 g ±10 %

16 mm x 276 mm ±5 %

GA869

118 g ±10 %

16 mm x 326 mm ±5 %

13. Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packaging. WARNING Risk of injury from sharp and/or pointed products! ► When disposing of or recycling the product, make sure the packaging prevents injuries from the product. Note The operator must process the product before 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. ► In case of questions regarding the disposal of the product, contact your

local B. Braun/Aesculap representative, see Technical Service.

After 350 processing cycles, the manufacturer tested the product and it passed.

12.3 Tool speed/Setting Adjustable motor direction

Clockwise/counterclockwise rotation

Adjustable maximum speed setting

10 000 rpm to 80 000 rpm

Step width for maximum speed setting

5 000 rpm

Default factory setting of upper speed range limit

75 000 rpm, right rotation

12.4 Short interval operation

■ 30 s application, 30 s pause ■ ∞ repetitions at 60 000 rpm ■ Max. temperature 48 °C

13