ELAN 4 air MIS handpiece GA760 and MIS handpiece shafts GB920R toGB927R

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Aesculap® ELAN 4 air MIS handpiece GA760 and MIS handpiece shafts GB920R to GB927R Legend

Manufacturer batch ID

1 ELAN 4 MIS hand piece shaft coupling 2 Unlocking sheath for hand piece shaft 3 Connection for motor hose 4 Slider for tool release 5 ELAN 4 MIS hand piece shaft (L10 or L13, straight or curved) 6 Length marking (L10 or L13) 7 ELAN 4 MIS shaft coupling 8 ELAN 4 MIS tool (L10 or L13) 9 ELAN 4 air oil spray adapter GB600850 10 ELAN 4 oil spray adapter for MIS handpiece shafts GB600870 11 Connection for applied part 12 Field of vision “On“ 13 Field of vision “Off“ 14 Release button 15 Nib on motor hose 16 Groove on connection for motor hose

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 3. 3.1 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 13.

About this document... Scope... Warnings... General information... Intended use... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... ELAN 4 MIS tools... 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... Mechanical cleaning/disinfecting with manual pre-cleaning application parts and MIS handpiece shafts... Inspection, maintenance and checks... Packaging... Steam sterilization... Storage... Maintenance... Troubleshooting list... Technical Service... Accessories/Spare parts... MIS hand Piece shafts... Technical Data... Classification in accordance with Regulation (EC) 2017/745. . Performance data, information about standards... 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

GA760

ELAN 4 air MIS handpiece

GB920R

ELAN 4 MIS hand piece shaft L10 straight

GB921R

ELAN 4 MIS handpiece shaft L10 bent

GB922R

ELAN 4 MIS handpiece shaft L10 curved

GB925R

ELAN 4 MIS hand piece shaft L13 straight

GB926R

ELAN 4 MIS handpiece shaft L13 bent

GB927R

ELAN 4 MIS handpiece 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.

2.

General information

2.1

Intended use

The ELAN 4 air MIS hand piece GA760 with shafts and tools is an accessory of the ELAN 4 air motor system. The hand piece is used with an ELAN 4 air motor hose GA705R connected to the ELAN 4 air foot control GA708 or to an ELAN 4 air motor hose with hand control GA706R or GA707R. The hand piece is used in combination with the ELAN 4 MIS hand piece shafts to drive the ELAN 4 MIS tools.

2.2

Application Environment

Application in the sterile area

2.3

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.

3

en 2.4

Absolute contraindications

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

2.5

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.

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.

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.

3.1

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, see instructions for use for tools TA012787. Single-use products

WARNING Risk of injury and damage to property due to improper handling of the product! This product is an accessory of the ELAN 4 air motor system. ► General operating instructions for ELAN 4 air foot control GA708, ELAN 4 air wall hoses, ELAN 4 air wall adapter (TA014450) and operating instructions for the ELAN 4 air motor hose with manual control (TA014481). ► 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. ► 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. ► Sterilize application parts, MIS handpiece shafts and motor hose before use. ► Observe the relevant instructions for use TA009721 when handling the Aesculap holder systems, see B. Braun eIFU under eifu.bbraun.com ► Use the applied parts and tools within the specified pressure range only.

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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 4.

Product description

6.

4.1

Package includes

WARNING Risk of infection and contamination! Application parts, MIS handpiece shafts and the motor hose are delivered non-sterile! ► Sterilize application parts, MIS handpiece shafts and the motor hose prior to use in accordance with the instructions for use.

Art. no.

Designation

GA760

ELAN 4 air MIS handpiece

GB600870

ELAN 4 oil spray adapters for MIS shafts

TA014476

Instructions for use for ELAN 4 air MIS handpiece GA760 and MIS handpiece shafts GB920R to GB927R (leaflet)

4.2

Components required for operation

■ ELAN 4 air wall adapter GA710R, GA712R, GA713R or GA715R ■ ELAN 4 air foot/hand control: – ELAN 4 air wall hose GA702R or GA703R, ELAN 4 air foot control GA708 and ELAN 4 air motor hose GA705R or – ELAN 4 air motor hose with manual control GA706R or GA707R ■ ELAN 4 MIS hand piece shaft ■ ELAN 4 MIS-tool

4.3

WARNING Risk of injury and material damage due to inadvertent activation of the applied part! ► Secure application parts that are not actively used against inadvertent activation (off position). 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.

Operating principle

The ELAN 4 air MIS hand piece is equipped with an ELAN 4 MIS shaft coupling and an ELAN 4 MIS tool coupling. The MIS hand piece is used with ELAN 4 air foot control or hand controls. The motor speed can be adjusted continuously by the foot/hand control. The MIS hand piece is operated in a clockwise direction. 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.

5.

Working with the product

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.

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 Control elements on the system components of the ELAN 4 air 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.

5

en Connecting the applied part to the motor hose ► Attach the connection for motor hose of the applied part 3 to the connection for applied part 11of the motor hose, see Fig. F. When doing so, ensure that the nib 15 on the motor hose is aligned with the groove on the connection for motor hose 16. The applied part engages. When the field of vision is “Off” 13 on the motor hose, a gold-colored marking is visible. Note The applied part attached to this motor hose is only ready for operation when the release button 14 is in "On" position 12. Disconnecting the applied part from the motor hose ► Lock the applied part ("Off" position), see Locking the applied part ("Off" position). ► Activate the release button 14 on the motor hose and pull at the connection for applied part 11 to disconnect the motor hose from the applied part, see Fig. F. Releasing the applied part for operation ("On" position) ► Activate the release button 14 on the motor hose and push the con-

nection for applied part 11 onto the applied part, see Fig. F. The applied part engages. When the field of vision is “On” 12 on the motor hose, a gold-colored marking is visible. Locking the applied part ("Off" position) ► Activate the release button 14 on the motor hose and remove the con-

nection for applied part, see Fig. F. The applied part engages. When the field of vision is “Off” 13 on the motor hose, a gold-colored marking is visible. Couple the MIS handpiece shaft to the application part ► Lock the applied part ("Off" position), see Locking the applied part

("Off" position). ► 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 the applied part ("Off" position), see Locking the applied part

("Off" position). ► 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.

6

Uncoupling the tool from the applied part ► Lock the applied part ("Off" position), see Locking the applied part ("Off" position). ► 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.

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 for secure coupling: Pull on the MIS

handpiece shaft. ► 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. 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 for damage, irregular operating noise, excessive vibrations and excessive warming. ► Check that the application part and/or the MIS handpiece shaft is 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. 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.

en 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. WARNING Risk of injury from foreign object 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. Operation of the applied part is only possible if:

■ the applied part is released, ■ a foot control or manual control is connected.

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".

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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 have to be properly oiled,see Inspection, maintenance and checks. The end of the service life is demonstrated by a relatively rapid rise of the temperature of the MIS handpiece shaft. ELAN 4 air MIS handpiece GA760 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: ECCOS install holder GB064R /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 GB064R/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.

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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 Mechanical cleaning/disinfecting with manual pre-cleaning application parts 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. ► Never immerse the applied part in liquids without a connected ELAN 4 air rinse adapter GB697R. To avoid the risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. ► Leave the rinsing adapter GB697R on the applied part for the entire cleaning process. Phase I ► Clean the application part and the MIS handpiece shafts under running

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 and use compressed air to blow all liquid out of the application part and the MIS handpiece shafts through the rinsing adapter GB697R/GB699R in order to prevent dilution of the disinfecting solution. ► Using a disposable syringe, fill the inside of the application part and the MIS handpiece shafts with disinfecting solution through the rinsing adapter GB697R/GB699R. ► Immerse the application part and the MIS handpiece shafts with the connected rinsing adapter for at least 5 min in disinfecting solution.

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 the MIS handpiece shafts using the rinsing adapter GB697R/GB699R at least 3x for 5 s using the pressurized water gun.

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 the MIS handpiece shafts using the rinsing adapter GB697R/GB699R at least 3x for 5 s using the pressurized water gun.

Phase II

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.

► Using a disposable syringe, fill the inside of the application part and the

MIS handpiece shafts with cleaning solution through the rinsing adapter GB697R/GB699R. ► Immerse the application part and the MIS handpiece shafts with the connected rinsing adapter for at least 5 min in an enzymatic cleaning solution. Note The MIS handpiece shafts can be immersed in the cleaning solution without the rinsing adapter. 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 the MIS handpiece shafts using the rinsing adapter GB697R/GB699R at least 3x for 5 s using the pressurized water gun.

9

en 7.8

Mechanical cleaning/disinfecting with manual pre-cleaning - application parts 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. ► Never process the application part without the ELAN 4 air rinsing

adapter GB697R connected. Immediately drain any fluid that has penetrated to avoid the risk of corrosion/malfunctioning. Phase I ► Clean the application part and the MIS handpiece shafts using a suit-

able 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 connection for motor hose 3 to ELAN 4 air rinse adapter

GB691R. ► Connect the shaft connection 7 to the ELAN 4 rinse system for four MIS hand piece shafts GB679R. ► Rinse the application part and the MIS handpiece shafts: – 3 times, each 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 connection for motor hose 3 to ELAN 4 air rinse adapter

7.10 Packaging

GB691R. ► Connect the shaft connection 7 to the ELAN 4 rinse 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 ELAN 4 rinsing device and rinsing adapter 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 packagings and holders used

(e.g. instructions for use TA009721 for Aesculap ECCOS holder system). ► Insert the application parts and the MIS handpiece shafts in the correct

position in the ECCOS holder GB064R/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 the MIS handpiece shafts to cool down to

room temperature. ► connect ELAN 4 air the oil spray adapter GB600850 9 (purple) to the connector for the motor hose 3 and use STERILIT Power Systems oil spray GB600 to spray through the application part for approx. 2 s, see Fig. D. ► place ELAN 4 the oil spray adapter for the MIS handpiece shafts GB600870 10 (white) on the shaft connector 7 and spray through the MIS handpiece shaft with STERILIT Power Systems oil spray GB600 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 list

Note For further information, see instructions for use for ELAN 4 air foot control GA708, ELAN 4 air wall hoses, ELAN 4 air wall adapter (TA014450) or instructions for use for ELAN 4 air motor hose with manual control (TA014481).

11. Accessories/Spare parts Art. no.

Designation

GB064R

ELAN 4 air ECCOS holder for MIS handpiece GA760

GB600

STERILIT Power Systems oil spray

GB600850

ELAN 4 air oil spray adapter

GB600870

ELAN 4 oil spray adapter for MIS shafts

GB691R

ELAN 4 air rinsing device for MIS handpiece

GB697R

ELAN 4 air rinsing adapter for MIS handpiece

GB679R

ELAN 4 rinsing device for four MIS handpiece shafts

GB699R

ELAN 4 rinsing 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 - disposable products/reusable products

TA014475

Instructions for use for ELAN 4 air MIS handpiece GA760 and MIS handpiece shafts GB920R to GB927R (A4 for folder)

TA014476

Instructions for use for ELAN 4 air MIS handpiece GA760 and MIS handpiece shafts GB920R to GB927R (leaflet)

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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11.1 MIS hand Piece shafts Art. no.

Designation

GB920R

ELAN 4 MIS handpiece shaft L10 straight

GB921R

ELAN 4 MIS handpiece shaft L10 bent

GB922R

ELAN 4 MIS hand piece shaft L10 curved

GB925R

ELAN 4 MIS handpiece shaft L13 straight

GB926R

ELAN 4 MIS hand piece shaft L13 bent

GB927R

ELAN 4 MIS handpiece shaft L13 curved

en 12. Technical Data

12.4 Ambient conditions

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

Application part

Art. no.

Designation

Class

GA760

ELAN 4 air MIS handpiece

GB920R

Operation

Transport and storage

Temperature

10 °C to 27 °C

-10 °C to 50 °C

IIa

Relative humidity

30 % to 75 %

10 % to 90 %

ELAN 4 MIS handpiece shaft L10 straight

IIa

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

GB921R

ELAN 4 MIS hand piece shaft L10 bent

IIa

Atmospheric pressure

GB922R

ELAN 4 MIS handpiece shaft L10 curved

IIa

GB925R

ELAN 4 MIS hand piece shaft L13 straight

IIa

GB926R

ELAN 4 MIS handpiece shaft L13 bent

IIa

GB927R

ELAN 4 MIS hand piece shaft L13 curved

IIa

12.2 Performance data, information about standards

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

Max. power

about 80 W at 8 bar

Note The operator must process the product before disposal, see Validated reprocessing procedure.

Max. torque

about 3.5 Ncm at 8 bar

► In case of questions regarding the disposal of the product, contact your

Max. motor speed

80 000 rpm at 8 bar

Weight

85 g ±10 %

Dimensions ∅ × L

18 mm x 89 mm ±5 %

Tool connection

ELAN 4 MIS

Rotational direction

Clockwise rotation

Pressure range

8 bar ±2 bar

ELAN 4 air MIS hand piece GA760

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

MIS hand piece shafts Art. no.

Designation

Dimensions (L)

Weight

GB920R

ELAN 4 MIS hand piece shaft L10 straight

111 mm ±5 %

14 g ±10 %

GB921R

ELAN 4 MIS hand piece shaft L10 bent

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 hand piece shaft L13 bent

141 mm ±5 %

19 g ±10 %

GB927R

ELAN 4 MIS hand piece shaft L13 curved

141 mm ±5 %

19 g ±10 %

12.3 Short-time intermittent operation

■ 30 second application, 30 second pause ■ ∞ repetitions ■ Max. Temperature 48 °C

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