ELAN 4 electro MIS handpiece GA860 and MIS handpiece shafts GB920R toGB927R

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Aesculap® ELAN 4 electro MIS handpiece GA860 and MIS handpiece shafts GB920R to GB927R Legend

Manufacturer batch ID

1 2 3 4 5 6 7 8 9

ELAN 4 MIS shaft coupling Unlocking sheath for hand piece Connector for motor cable Slider for tool release ELAN 4 MIS hand piece shaft (L10 or L13, straight or curved) Length marking (L10 or L13) ELAN 4 MIS shaft connection ELAN 4 MIS tool (L10 or L13) Symbol of the applied part type in display of ELAN 4 electro control unit 10 ELAN 4 single-use spray nozzle for MIS handpiece shafts 11 Tube connector on spray nozzle 12 ELAN 4 electro oil spray adapter GB600860 13 ELAN 4 oil spray adapter for MIS shafts GB600870

Symbols on product and packages 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

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 Medical device

en 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 5. 6. 6.1 6.2 6.3 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. 11.1 12. 12.1 12.2 12.3 12.4 12.5 13.

About this document... Scope... Warnings... General information... Intended use... Main functions and design characteristics... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Sterile ELAN 4 MIS tools... Sterile ELAN 4 single-use spray nozzles... Product description... Package includes... Components required for operation... Operating principle... Preparation... Working with the product... System set-up... Function check... Operation... 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 – application part and MIS handpiece shafts... Machine cleaning/disinfection including manual pre-cleaning – application part and MIS handpiece shafts... Inspection, maintenance and checks... Packaging... Steam sterilization... Storage... Maintenance... Troubleshooting... Technical Service... Accessories/Spare parts... MIS handpiece shafts... Technical Data... Classification in accordance with Regulation (EC) 2017/745. . Performance data, information about standards... Tool speed/Setting... Short-time intermittent operation... Ambient conditions... Disposal...

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1.

About this document

1.1

Scope

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

Designation

GA860

ELAN 4 electro MIS handpiece

GB920R

ELAN 4 MIS hand piece shaft L10 straight

GB921R

ELAN 4 MIS hand piece shaft L10 bent

GB922R

ELAN 4 MIS handpiece shaft L10 curved

GB925R

ELAN 4 MIS handpiece shaft L13 straight

GB926R

ELAN 4 MIS hand piece shaft L13 bent

GB927R

ELAN 4 MIS hand piece shaft L13 curved

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

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2.

General information

2.1

Intended use

The ELAN 4 electro MIS hand piece GA860 with shafts and tools is an accessory of the ELAN 4 electro motor system. The MIS hand piece is connected by an ELAN 4 electro motor cable to the control unit. The hand piece is used in combination with the ELAN 4 MIS hand piece shafts to drive the ELAN 4 MIS tools.

2.2

Main functions and design characteristics

Speed min. 0 rpm to max. 80 000 rpm Rotational direction Right and left rotation

3

en Short-time intermittent operation ■ 30 s application, 30 s pause ■ ∞ repetitions at 60,000 min-1 ■ 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 indicated here. 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

Application Environment

Application in the sterile area

2.4

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 hand piece shafts and tools selected.

► Clean brand-new product after removal of the transport packaging and

before the first sterilization (manually or mechanically). ► 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, MIS handpiece shafts 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.

3.1 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. ► 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. 4

Sterile ELAN 4 MIS 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, refer to the instructions for use for tools TA012787. Single-use products 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.

en 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.

5.

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.

6.

Working with the product

► 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 prod-

uct if it is damaged. ► Do not use the product after its use-by date.

4.

Product description

4.1

Package includes

Art. no.

Designation

GA860

ELAN 4 electro MIS handpiece

GB600870

ELAN 4 oil spray adapters for MIS shafts

TA014441

Instructions for use for ELAN 4 electro MIS handpiece GA860 and MIS handpiece shafts GB920R to GB927R (leaflet)

4.2

Components required for operation

4.3

Operating principle

■ Operation-ready ELAN 4 electro control unit GA800, see TA014401 ■ ELAN 4 MIS hand piece shaft ■ ELAN 4 MIS-tool The ELAN 4 electro MIS handpiece is equipped with ELAN 4 a MIS shaft coupling and an ELAN 4 MIS tool coupling. The MIS hand piece is used with ELAN 4 electro foot controls or hand controls. For the MIS handpiece, the clamped tool rotates at the set motor speed. The motor speed of the MIS handpiece can be adjusted continuously by the foot/manual control. The MIS hand piece can be operated in right or left (clockwise or counterclockwise) rotation mode. Note The length marking L10/L13 shows the shaft length of the tool to be utilized. Only ELAN 4 MIStools may be coupled to the application part in which the length marking (L10/L13) of the MIS handpiece shaft and tool match.

WARNING Risk of infection and contamination! Application parts, MIS handpiece shafts and motor cables are delivered non-sterile! ► Sterilize application parts, MIS handpiece shafts and motor cables 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

WARNING Coupling/uncoupling MIS handpiece shafts/tools in the "On" position can cause injuries if the application part is accidentally activated! ► Only couple/uncouple MIS handpiece shafts/tools in the "Off" position. WARNING Risk of injury due to small parts that could enter the operation site! ► Do not couple/uncouple MIS handpiece shafts/tools above the surgical field. Note Operating elements on the system components of the ELAN 4 electro motor system are labeled with a gold marking.

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en 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. Couple the MIS handpiece shaft to the application part ► Lock the applied part (Off position), see instructions for use of ELAN 4 electro control unit GA800 (TA014401). ► Push the ELAN 4 MIS hand piece shaft 5 up to the stop into ELAN 4 MIS

shaft coupling 1. The ELAN 4 MIS hand piece shaft clicks into place. ► Pull on the ELAN 4 MIS hand piece shaft 5 to make sure it is securely attached. Uncouple the MIS handpiece shaft from the application part ► Pull back the unlocking sheath 2 on the applied part and pull the

ELAN 4 MIS hand piece shaft 5 out of the ELAN 4 MIS shaft coupling 1. Coupling the tool to the applied part WARNING Injury and material damage may result from wrong combinations of MIS handpiece shafts and tools! ► Do not operate the L13 tool in the L10 MIS handpiece shaft. Note The tool is difficult to insert into/remove from the bent MIS handpiece shafts because of the bend. ► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401). ► Push tool 8 up to the stop in ELAN 4 MIS hand piece shaft 5, see Fig. A.

The tool engages. ► Pull at tool 8 to check that it is securely coupled.

Uncoupling the tool from the applied part ► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401).

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 the MIS handpiece shaft 5 for secure coupling: Pull on the MIS

handpiece shaft 5. ► Pull on the tool to check that it is securely coupled. ► Check that the cutting edges of the tools are not showing any mechan-

ical damage. ► Activate the application part for operation (on position) and pull on the unlocking sleeve 2. In doing so, make sure the MIS handpiece shaft is not decoupled. ► Briefly run the applied part at maximum speed. ► Check the application part and the MIS handpiece shaft 5 for damage, irregular operating noise, excessive vibrations and excessive warming. ► Check that the application part and the MIS handpiece shaft are only hand-hot after a short period of use. ► Do not use the product if it is damaged or defective. Set aside the product 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.

► Pull the slide for tool release 4 on the applied part and pull tool 8 out

of ELAN 4 MIS hand piece shaft 5, see Fig. A. Mounting the spray nozzle and tube set ► Connect the tube set GA395SU to the pump of the ELAN 4 electro con-

trol unit GA800, refer to TA014401. ► Push the application-side tube end onto the tube connector of the sin-

gle-use spray nozzle for the MIS handpiece shaft 11. ► Push the single-use spray nozzle for the MIS handpiece shaft 10 onto

the ELAN 4 MIShand piece shaft 5 and position it by pushing/turning, see Fig. A. Note The spray tube of the single-use spray nozzle for the MIS handpiece shaft can be easily bent by hand and can be adapted to the requirements of the application (e.g. aligned to the tool head).

6

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. WARNING Risk of injury from bent or snapped tools! ► Only use perfectly straight tools. ► Only apply mild pressure when using a tool. ► Avoid overstraining (e. g. bending) of tools during operation.

en 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. WARNING Risk of injury if the tool comes loose accidentally! ► Check for secure fixation of the tool after any tool change. WARNING Risk of injury and infection if surgical gloves are damaged by sharp cutting edges! ► Avoid contact with cutting tools. 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 damage to the tool due to removal or dissection of other materials than bone or when removing hard or soft tissue (e. g. sawing into instruments or implants). Risk of injuries and infections caused by the abrasion debris produced in this way! ► When operating, be careful to avoid contact with tools, implants and similar objects. CAUTION Damage to micro instruments caused by incorrect handling! ► Protect products against overstraining. ► Do not bend the hand piece shaft. ► Do not use the shaft as a lever. 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 9 is shown on 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. 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

en 7.3

Reusable products

MIS handpiece shafts The MIS handpiece shaft has a limited service life. When used as intended, a minimum of 30 uses are guaranteed. To this end, the MIS handpiece shafts, see Inspection, maintenance and checks have to be properly oiled. The end of the service life is demonstrated by a relatively rapid rise of the temperature of the MIS handpiece shaft. ELAN 4 electro MIS handpiece GA860 The service life of the product is limited by damage, normal wear, kind and duration of the usage, 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

► 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

cleaning and disinfection within 6 hours.

7.5

Preparation before cleaning

Application part and MIS handpiece shafts ► Prior to first mechanical cleaning/disinfection: Install the ECCOS holder GB084R/GB723R in a suitable tray (e.g. JF222R). ► Insert the application part and the MIS handpiece shafts in the correct position in the ECCOS holder GB084R/GB723R, see Fig. B or Fig. C.

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.

8

Validated cleaning and disinfection procedure Product

Validated procedure

Reference

Application part and MIS handpiece shafts

Manual cleaning with immersion disinfection

see Manual cleaning with immersion disinfection – application part and MIS handpiece shafts

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

see Machine cleaning/disinfection including manual pre-cleaning – application part and MIS handpiece shafts

en 7.7

Manual cleaning with immersion disinfection – application part and MIS handpiece shafts

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, QUATfree, 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 application part and the MIS handpiece shafts in an ultrasonic bath. Phase I ► Clean the application part and the MIS handpiece shafts under running

water, using a suitable cleaning brush until all visible residues have been removed from the surfaces. Do not brush the inside of the MIS handpiece shafts. ► Mobilize non-rigid components, such as release button, unlocking sleeve, etc. during cleaning. ► Rinse the application part and MIS handpiece shafts using the rinsing adapter GB698R/GB699R at least 3x for 5 s using the pressurized water gun. Phase II ► Using a disposable syringe, fill the inside of the application part and of

the MIS handpiece shafts with cleaning solution through the rinsing adapter(s) GB698R/GB699R. ► Immerse the application part and the MIS handpiece shafts with the connected rinsing adapter for at least 5min in an enzymatic cleaning solution. Note The MIS handpiece shafts can also be immersed in the cleaning solution without the rinsing adapter.

Phase IV ► Prior to manual disinfection, allow rinsing water to drain off the application part and the MIS handpiece shafts for a sufficient length of time then use compressed air to blow all liquid out of the application part and the MIS handpiece shafts through the rinsing adapter GB698R/GB699R to prevent dilution of the disinfecting solution. ► Using a disposable syringe, fill the inside of the application part and of the MIS handpiece shafts with disinfecting solution through the rinsing adapter(s) GB698R/GB699R. ► Immerse the application part and the MIS handpiece shafts with the connected rinsing adapter for at least 5 min in disinfecting solution. Phase V ► Rinse the entire application part and the MIS handpiece shafts (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as release button, unlocking sleeve, etc. during cleaning. ► Rinse the application part and MIS handpiece shafts using the rinsing adapter GB698R/GB699R at least 3x for 5 s using the pressurized water gun. Phase VI ► Use suitable equipment (e.g. cloth, compressed air) to dry the application part and the MIS handpiece shafts in the drying phase. ► After manual cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

Phase III ► Rinse the entire application part and the MIS handpiece shafts (all

accessible surfaces) under running water. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during rinsing. ► Rinse the application part and MIS handpiece shafts using the rinsing

adapter GB698R/GB699R at least 3x for 5 s using the pressurized water gun.

9

en 7.8

Machine cleaning/disinfection including manual pre-cleaning – application part and MIS handpiece shafts

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 application part and the MIS handpiece shafts in an

ultrasonic bath. Phase I ► Clean the application part and the MIS handpiece shafts under running

water using a suitable cleaning brush until all visible residues have been removed from the surfaces. Do not brush the inside of the MIS handpiece shafts. ► Mobilize non-rigid components, such as release button, unlocking sleeve, etc. during cleaning. Phase II ► Connect the connector for motor cable 3 with ELAN 4 electro rinsing

device GB692R. ► Connect the shaft connection 7 to the ELAN 4 flush system for four MIS hand piece shafts GB679R. ► Rinse the application part and the MIS handpiece shafts: – 3 times for 5 seconds using a water gun or – for 5 min with a tap/hose

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

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

7.10 Packaging

device GB692R. ► Connect the shaft connection 7 to the ELAN 4 flush system for four MIS hand piece shafts GB679R. ► 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 the MIS handpiece shafts, see the instructions for use for the ELAN 4 rinsing device and the rinsing adapter(s) TA014447 or TA014448. – Visually check for residue on visible surfaces and repeat the cleaning/disinfection process if necessary.

► Observe the instructions for use of the packaging and holders used (e.g.

instructions for use TA009721 for AesculapECCOS holder system). ► Insert the application part and the MIS handpiece shafts in the correct

position in the ECCOS holder GB084R/GB723R, see Fig. B or 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.

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

exposed to the sterilizing agent. ► Validated sterilization process

7.9

Inspection, maintenance and checks

► Allow application parts and MIS handpiece shafts to cool down to room

temperature. ► Connect the ELAN 4 electro oil spray adapter GB600860 12 (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. ► Place the ELAN 4 oil spray adapter for MIS shafts GB600870 13 (white) on the shaft connector 7 and spray STERILIT Power Systems oil spray GB600 through the MIS handpiece shaft for approx. 2 s, see Fig. E. Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, couplings) using the Aesculap STERILIT Power Systems oil spray.

– 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.

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

a dry, dark, temperature-controlled area.

► Inspect the product after every cleaning and disinfecting cycle for:

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

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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.

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

9.

Troubleshooting

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

10. Technical Service 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. 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. 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.

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11. Accessories/Spare parts Art. no.

Designation

GB796SU

Single-use spray nozzle for MIS hand piece shafts L10

GB797SU

Single-use spray nozzle for MIS hand piece shafts L13

GA395SU

ELAN 4 electro single-use tube set

GB084R

ELAN 4 electro ECCOS holder for MIS handpiece GA860

GB600

STERILIT Power Systems oil spray

GB600860

ELAN 4 electro oil spray adapter

GB600870

ELAN 4 oil spray adapters for MIS shafts

GB692R

ELAN 4 electro rising device for MIS handpiece

GB698R

ELAN 4 electro rising adapter for MIS handpiece

GB679R

ELAN 4 rinsing device for four MIS handpiece shafts

GB699R

ELAN 4 rising adapter for MIS handpiece shafts

GB723R

ELAN 4 ECCOS holder for two MIS handpiece shafts

TA012787

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

TA014440

Instructions for use for ELAN 4 electro MIS handpiece GA860 and MIS handpiece shafts GB920R to GB927R (A4 for folder)

TA014441

Instructions for use for ELAN 4 electro MIS handpiece GA860 and MIS handpiece shafts GB920R to GB927R (leaflet)

11.1 MIS handpiece shafts Art. no.

Designation

GB920R

ELAN 4 MIS handpiece shaft L10 straight

GB921R

ELAN 4 MIS handpiece shaft L10 bent

GB922R

ELAN 4 MIS handpiece shaft L10 curved

GB925R

ELAN 4 MIS handpiece shaft L13 straight

GB926R

ELAN 4 MIS handpiece shaft L13 bent

GB927R

ELAN 4 MIS handpiece shaft L13 curved

en 12. Technical Data

12.3 Tool speed/Setting

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

Adjustable motor direction

Clockwise/counterclockwise rotation

Adjustable maximum speed setting

10 000 rpm to 80 000 rpm

Increment of the upper speed range limit

5 000 rpm

Default factory setting of upper speed range limit

75 000 rpm, right rotation

Art. no.

Designation

Class

GA860

ELAN 4 electro MIS handpiece

IIa

GB920R

ELAN 4 MIS handpiece shaft L10 straight

IIa

GB921R

ELAN 4 MIS handpiece shaft L10 bent

IIa

GB922R

ELAN 4 MIS handpiece shaft L10 curved

IIa

GB925R

ELAN 4 MIS handpiece shaft L13 straight

IIa

GB926R

ELAN 4 MIS handpiece shaft L13 bent

IIa

GB927R

ELAN 4 MIS handpiece shaft L13 curved

IIa

12.4 Short-time intermittent operation

■ 30 second application, 30 second pause ■ ∞ repetitions at 60 000 min-1 ■ Max. Temperature 48 °C

12.2 Performance data, information about standards

12.5 Ambient conditions

ELAN 4 electro MIS handpiece GA860

Application part

Max. power

approx. 140 W

Max. torque

approx. 2.2 Ncm

Max. motor speed

Operation

Transport and storage

Temperature

10 °C to 27 °C

-10 °C to 50 °C

80 000 rpm

Relative humidity

30 % to 75 %

10 % to 90 %

Weight

100 g ±10 %

500 hPa to 1 060 hPa

17 mm x 118 mm x ±5 %

Atmospheric pressure

700 hPa to 1 060 hPa

Dimensions ∅ × L Tool connector

ELAN 4 MIS shaft

Application part

Type BF

EMC

IEC/DIN EN 60601-1-2

Conforming to standard

IEC/EN 60601-1

13. Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packaging.

After 350 processing cycles, the manufacturer tested the product and it passed. MIS hand piece shafts Art. no.

Designation

Dimensions (L)

Weight

GB920R

ELAN 4 MIS handpiece shaft L10 straight

111 mm ±5 %

14 g ±10 %

GB921R

ELAN 4 MIS handpiece shaft L10 curved

111 mm ±5 %

14 g ±10 %

GB922R

ELAN 4 MIS handpiece shaft L10 curved

111 mm ±5 %

14 g ±10 %

GB925R

ELAN 4 MIS handpiece shaft L13 straight

141 mm ±5 %

19 g ±10 %

GB926R

ELAN 4 MIS handpiece shaft L13 curved

141 mm ±5 %

19 g ±10 %

GB927R

ELAN 4 MIS handpiece shaft L13 curved

141 mm ±5 %

19 g ±10 %

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.

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