ELAN 4 cleaning devices GB691R (air) GB692R (electro) GB679R (MIShand piece shafts) and ELAN 4 rinsing adaptor GB697R (air) GB698R(electro) GB699R (MIS hand piece shafts)

GB697R GB691R

GB698R GB692R

GB699R GB679R

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Aesculap® ELAN 4 cleaning devices GB691R (air) / GB692R (electro) / GB679R (MIS hand piece shafts) and ELAN 4 rinsing adaptor GB697R (air) / GB698R (electro) / GB699R (MIS hand piece shafts) Legend

Contents

1 2 3 4 5 6 7 8 9

1. 1.1 1.2 2. 2.1 2.1.1 2.1.2 3. 4. 4.1 4.1.1 4.1.2 4.2 5.

Connector for rinsing tube Applied part/shaft connector Control button/lever Filter lid Filter Silicon washer Rinsing tube ELAN 4 applied part/MIS hand piece shaft Connector for water/compressed-air gun

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

Manufacturer

5.1 5.2 5.2.1 5.2.2

Date of manufacture

Manufacturer's order number

5.2.3 5.3 5.3.1 5.3.2 5.4 5.5 5.6

Connector for water/compressed-air gun

5.6.1

Non-sterile medical device

Manufacturer batch ID

5.6.2 5.6.3 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

5.7 6. 6.1 6.1.1 6.1.2 6.1.3 6.2 6.3 6.4

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About this document... Scope... Warnings... General information... Intended purpose... Cleaning device... Rinsing adaptor... Safe handling... Product description... Package includes... ELAN 4 cleaning devices... ELAN 4 rinsing adaptors... Operating principle... Handling the cleaning device for manual precleaning/machine cleaning and disinfection... Changing the filter in the cleaning device... Assembling the cleaning device... Mounting the ELAN 4 air applied part onto the cleaning device GB691R... Mounting the ELAN 4 electro applied part onto the cleaning device GB692R... Mounting the ELAN 4 MIS hand piece shaft onto GB679R . . Manual pre-cleaning with cleaning device... Pre-cleaning using water gun (option 1, recommended)... Pre-cleaning using rinsing tube (option 2, recommended) . . . Machine cleaning and disinfection using cleaning device . . . Remove the rinsing water... Dismantle applied parts/MIS hand piece shafts from the cleaning device... Removing the ELAN 4 air applied part from cleaning device GB691R... Removing the ELAN 4 electro applied part from cleaning device GB692R... Removing the ELAN 4 MIS hand piece shaft from cleaning device GB679R... Cleaning the filter in the cleaning device... Handling the rinsing adaptor for manual cleaning and disinfection... Connecting the rinsing adaptor... Mounting the ELAN 4 air applied part onto the rinsing adaptor GB697R... Mounting the ELAN 4 electro applied part onto the rinsing adaptor GB698R... Mounting the ELAN 4 MIS hand piece shaft onto the rinsing adaptor GB679R... Manual cleaning and disinfecting using rinsing adaptor... Remove the rinse water... Remove application parts/MIS hand piece shafts from the rinsing adaptor...

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

en 6.4.1

7. 8. 9. 10. 11.

Removing the ELAN 4 air applied part from rinsing adaptor GB697R... Removing the ELAN 4 electro applied part from rinsing adaptor GB698R... Mount the ELAN 4 MIS hand piece shaft onto the rinsing adaptor GB699R... Inspection, maintenance and checks... Troubleshooting list... Technical Service... Accessories/Spare parts... Disposal...

1.

About this document

1.1

Scope

6.4.2 6.4.3

6 6 6 6 6 7 7 7

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

Designation

GB679R

ELAN 4 cleaning system for four MIS hand piece shafts

GB691R

ELAN 4 air cleaning device

GB692R

ELAN 4 electro cleaning device

GB697R

ELAN 4 air rinsing adaptor

GB698R

ELAN 4 electro rinsing adaptor

GB699R

ELAN 4 rinsing adaptor for MIS hand piece shafts

► 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: 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

Note These instructions for use describe how to use the cleaning device and rinsing adaptor only. Detailed information about the reprocessing of the applied parts/MIS hand piece shafts are described in the instructions for use of the applied parts/MIS hand piece shafts. Note ELAN 4 electro and air applied parts are jointly referred to as "applied parts" in these instructions for use.

2.1

Intended purpose

2.1.1 Cleaning device ELAN 4 cleaning devices are used in the CSSD (Central Sterile Services Department). The cleaning devices are used to hold application parts and MIS hand piece shafts during processing. ELAN 4 cleaning devices are used in manual pre-cleaning and in mechanical cleaning and disinfection in the washer-disinfector. Note The cleaning device is unsuitable as a holder for the sterilization of the applied parts or MIS hand piece shafts. 2.1.2 Rinsing adaptor ELAN 4 rinsing adaptors are used in the CSSD (Central Sterile Services Department). The rinsing adaptors are used to hold application parts and MIS hand piece shafts during processing. ELAN 4 rinsing adaptors are used in manual pre-cleaning and manual cleaning and disinfection. Note The cleaning device is unsuitable as a holder for the sterilization of the applied parts or MIS hand piece shafts. Note The rinsing adaptor does not have a water filter and is therefore unsuitable for mechanical cleaning and for connecting to the cleaning and disinfection machine.

3.

Safe handling

► Remove the transport packaging and clean the new product, either

manually or mechanically, prior to its initial use. ► 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. Note The user must report all serious incidents occurring in connection with the product to the manufacturer and to the competent authority of the country in which the user is registered. Restriction of re-usability 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. 3

en 4.

Product description

4.1

Package includes

4.1.1

ELAN 4 cleaning devices

Art. no. GB691R

Name

5.

Handling the cleaning device for manual pre-cleaning/machine cleaning and disinfection

5.1

Changing the filter in the cleaning device

Note The quality of cleaning is dependent on the pore size and flow rate of the filter. Successful cleaning is only guaranteed with the GB693 filter.

GB679R

ELAN 4 air cleaning device – or – ELAN 4 electro cleaning device – or – ELAN 4 cleaning system for four MIS hand piece shafts

GB693

Filter (10 pcs.)

O71511

Poster for ELAN 4 machine processing

► Remove silicone washer 6 from filter lid 4.

TA014448

Instructions for use for ELAN 4 cleaning devices GB691R (air) / GB692R (electro) / GB679R (MIS hand piece shafts) and ELAN 4 rinsing adaptor GB697R (air) / GB698R (electro) / GB699R (MIS hand piece shafts)

► Remove filter 5 from filter lid 4 and dispose of it.

GB692R

4.1.2

ELAN 4 rinsing adaptors

Art. no.

Designation

GB697R

ELAN 4 air rinsing adaptor – or – ELAN 4 electro rinsing adaptor – or – ELAN 4 rinsing adaptor for four MIS hand piece shafts

GB698R GB699R TA014448

4.2

User information for ELAN 4 cleaning devices GB691R (air) / GB692R (electro) / GB679R (MIS hand piece shafts) and ELAN 4 rinsing adaptor GB697R (air) / GB698R (electro) / GB699R (MIS hand piece shafts)

Operating principle

The cleaning device and rinsing adaptor are used for internal and external cleaning of applied parts MIS hand piece shafts. The cleaning device and rinsing adaptor prevent applied parts MIS hand piece shafts from being damaged during the cleaning process and ensure that the detergents reach all necessary areas inside the applied parts MIS hand piece shafts. The integrated filter of the cleaning device prevents dirt particles from getting from the cleaning solution into the applied parts MIS hand piece shafts.

Note The filter must be changed at least once a week. ► Unscrew filter lid 4, see Fig. A.

► Clean inside of filter lid 4. ► Insert a new filter 5 in filter lid 4. ► Insert the silicone washer 6 in the correct position in the filter lid 4. ► Screw filter lid 4 on tight.

5.2

Assembling the cleaning device

5.2.1

Mounting the ELAN 4 air applied part onto the cleaning device GB691R ► Press control button 3 and push ELAN 4 air applied part 8 onto adaptor 2 as far as it will go, see Fig. B. ► Release control button 3. ► Make certain that the ELAN 4 air applied part 8 is securely seated. 5.2.2

Mounting the ELAN 4 electro applied part onto the cleaning device GB692R ► Push the ELAN 4 electro applied part 8 onto adaptor 2 as far as it will go, see Fig. B. ► Make certain that the ELAN 4 electro applied part 8 is securely seated. 5.2.3 Mounting the ELAN 4 MIS hand piece shaft onto GB679R ► Press activation button 3 and slide ELAN 4 MIS hand piece shaft 8 onto the connector 2 up to the stop, see Fig. B. ► Release the activation button 3. ► Check the seat of the ELAN 4 MIS hand piece shaft 8.

5.3

Manual pre-cleaning with cleaning device

5.3.1 Pre-cleaning using water gun (option 1, recommended) ► Apply water gun to connector for water/compressed-air gun 9, see Fig. B. ► Cover connector for flushing hose 1 with absorbent cellulose wadding or similar material. Water must come out of the tip of the applied part/MIS hand piece shaft. Applied parts/shaft connectors not occupied 2 must be leaktight. ► Remove water gun from connector for water/compressed-air gun 9. 5.3.2 Pre-cleaning using rinsing tube (option 2, recommended) ► Connect rinsing tube 7 to connector for rinsing tube 1 and to the water supply line, see Fig. B. Water must come out of the tip of the applied part/MIS hand piece shaft. Empty applied part/shaft adaptors and connector 2 for water/compressed-air gun 9 must be leak-tight. ► Remove the rinsing tube 7 from the cleaning device.

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en 5.4

Machine cleaning and disinfection using cleaning device

CAUTION Insufficient quantity of rinsing water will result in incomplete cleaning of the applied parts! ► Connect the rinsing tube directly and without branching to the rinsing bracket in the cleaning and disinfecting machine. ► Close any unused rinsing ports on the rinsing bracket of the cleaning and disinfecting machine. ► Connect rinsing tube 7 to rinsing tube connector 1 and to rinsing

bracket in the cleaning and disinfecting washer, see Fig. B. Note The adaptors required to connect to the rinsing bracket are not included in the delivery.

5.7

Cleaning the filter in the cleaning device

CAUTION Incomplete cleaning due to a dirty filter! ► Blow air through filter after each wash cycle without applied parts. ► Change the filter weekly. ► Do not reuse the filter after disassembly. CAUTION Dirty filter due to incorrect use of the compressed-air gun! ► Ensure that the compressed-air gun is in close contact with the connector for water/compressed-air gun. ► Apply the compressed-air gun directly to the connector for water/com-

pressed-air gun 9. ► Forcefully blow compressed air through filter 5 in the cleaning device

for at least 3 seconds.

5.5

Remove the rinsing water

CAUTION Rinsing water remaining in application parts/MIS hand pieces shafts! ► Ensure that the compressed-air gun is in close contact with the connector for water/compressed-air gun. ► Detach rinsing tube 7 from connector for rinsing tube 1, see Fig. B. ► Cover connector for rinsing tube 1 with absorbent cellulose wadding or

similar material. ► Apply the compressed-air gun directly to connector for water/com-

pressed-air gun 9 of the cleaning device, see Fig. B. ► Use compressed air to remove any remaining water from application

parts/MIS hand piece shafts attached to cleaning devices.

5.6

Dismantle applied parts/MIS hand piece shafts from the cleaning device

5.6.1

Removing the ELAN 4 air applied part from cleaning device GB691R ► Press the control button 3 and pull the ELAN 4 air application part 8 off the cleaning device, see Fig. B. 5.6.2

Removing the ELAN 4 electro applied part from cleaning device GB692R ► Press the actuating lever 3 and pull the ELAN 4 electro application part 8 off the cleaning device, see Fig. B. 5.6.3

Removing the ELAN 4 MIS hand piece shaft from cleaning device GB679R ► Press the control button 3 and pull the ELAN 4 MIS hand piece shaft 8 off the cleaning device, see Fig. B.

6.

Handling the rinsing adaptor for manual cleaning and disinfection

6.1

Connecting the rinsing adaptor

6.1.1

Mounting the ELAN 4 air applied part onto the rinsing adaptor GB697R ► Press the control button 3 and slide the ELAN 4 air application part piece 8 onto the connector 2 up to the stop, see Fig. C. ► Release the activation button 3. ► Make certain that the ELAN 4 air applied part 8 is securely seated. 6.1.2

Mounting the ELAN 4 electro applied part onto the rinsing adaptor GB698R ► Slide the ELAN 4 electro application part 8 onto the connector 2 as far as it will go, see Fig. C. ► Make certain that the ELAN 4 electro applied part 8 is securely seated. 6.1.3

Mounting the ELAN 4 MIS hand piece shaft onto the rinsing adaptor GB679R ► Press the control button 3 and slide the ELAN 4 MIS hand piece shaft 8 onto the connector 2 as far as it will go, see Fig. C. ► Release control button 3. ► Check the seat of the ELAN 4 MIS hand piece shaft 8.

6.2

Manual cleaning and disinfecting using rinsing adaptor

CAUTION Risk of corrosion/malfunction. ► Never immerse the ELAN 4 air application parts in liquids without a connected ELAN 4 air rinsing adaptor GB697R. ► Immediately drain any fluid that has penetrated the device. ► To use the water/air gun and disposable syringe with cleaning and dis-

infection solution, attach it to the water/air gun port 9. ► Fill cleaning/disinfection solution into application part/MIS hand piece

shaft. It has to come out at the tip of the application part/MIS hand piece.

5

en 6.3

Remove the rinse water

6.4

CAUTION Rinsing water remaining in application parts/MIS hand pieces shafts! ► Ensure that the compressed-air gun is in close contact with the connector for water/compressed-air gun. ► Apply compressed-air gun directly to connector for water/compressed-

air gun 9 of the rinsing adaptor, see Fig. C. ► Use compressed air to remove any remaining water from application parts/MIS hand piece shafts including rinsing adaptors.

Remove application parts/MIS hand piece shafts from the rinsing adaptor

6.4.1

Removing the ELAN 4 air applied part from rinsing adaptor GB697R ► Press the control button 3 and pull the ELAN 4 air application part 8 off the rinsing adaptor, see Fig. C. 6.4.2

Removing the ELAN 4 electro applied part from rinsing adaptor GB698R ► Press actuating lever 3 and pull the ELAN 4 electro application part 8 off the rinsing adaptor, see Fig. C. 6.4.3

Mount the ELAN 4 MIS hand piece shaft onto the rinsing adaptor GB699R ► Press the control button 3 and pull the ELAN 4 MIS hand piece shaft 8 off the rinsing adaptor, see Fig. B.

7.

Inspection, maintenance and checks

The cleaning device and rinsing adaptor are unsuitable as a holder for the sterilization of the applied parts/MIS hand piece shaft. ► After accidental sterilization of the cleaning device: Change filter, see ► Inspect the product after each cleaning and disinfecting cycle to be Changing the filter in the cleaning device. sure it is: clean, functional, and undamaged. ► Set aside the product if it is damaged. ► Allow the product to cool down to room temperature.

8.

Troubleshooting list

Fault

Detection

Cause

Remedy

Defective applied part/shaft connector

Application parts/MIS hand piece shafts cannot be coupled

Adaptor damaged

Have the cleaning device/rinsing adaptor repaired or replaced by the Aesculap Technical Service.

Dirty filter

Applied parts/MIS hand piece shafts are not clean on the inside

Filter not replaced

Change filter at least once per week

Air not blown through filter

Blow air through filter after every wash cycle.

Filter is not inserted

Application parts/MIS hand piece shafts not clean

Particles from the rinsing fleet may incur into the applied parts/MIS hand piece shafts

Insert a new filter. Clean the applied parts/MIS hand piece shafts repeatedly

Silicon washer is not inserted

Applied parts/MIS hand piece shafts are not clean

Particles from the washing/rinsing water may penetrate the applicable part/MIS hand piece shafts

Insert silicone washer. Repeatedly clean application parts/MIS hand piece shafts.

6

en 9.

Technical Service

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.

10. Accessories/Spare parts Art. no.

Name

GB693

Filter (10 pcs.)

TA014447

Instructions for use for ELAN 4 cleaning devices GB691R (air) / GB692R (electro) / GB679R (MIS hand piece shafts) and ELAN 4 rinsing adaptor GB697R (air) / GB698R (electro) / GB699R (MIS hand piece shafts) (A4 for ring binder)

TA014448

Instructions for use for ELAN 4 cleaning devices GB691R (air) / GB692R (electro) / GB679R (MIS hand piece shafts) and ELAN 4 rinsing adaptor GB697R (air) / GB698R (electro) / GB699R (MIS hand piece shafts) (Flyer)

11. Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packaging. Note The operator must process the product before disposal. ► In case of questions regarding the disposal of the product, contact your

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

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