Assistina 301 plus Instructions for Use Rev 019

Contents Symbols... 4 In the instructions for use... 4 On the medical device... 5 On the packaging/cartridge... 6 1. Introduction... 7 2. Unpacking... 9 3. Scope of delivery... 10 4. Safety notes... 11 5. Description...12 Front side...12 Rear side...13 6. Start-up...14 Initial filling...17 7. Operation... 20 Maintenance process... 20 Attaching / removing the adaptor...21 Maintenance process... 22 Lubrication of chucking system... 24 8. Cleaning... 25 9. W&H accessories... 26

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10. Maintenance... 28 O-rings replacement... 29 Filter replacement... 30 Air filter replacement... 31 11. Servicing... 32 Returns... 32 Preparation of returns... 33 12. Technical data... 34 13. Disposal... 35 Explanation of warranty terms... 36 Authorised W&H service partners... 37

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Symbols

4

In the instructions for use

WARNING! (risk of injury)

ATTENTION! (to prevent damage occurring)

ATTENTION! General explanations with no danger to persons or property

CE mark

Do not dispose with domestic waste

WARNING! Flammable liquid and vapour

Symbols Consult instructions for use

On the medical device

Date of manufacture

DataMatrix Code for product information including UDI (Unique Device Identification)

CE mark

Manufacturer

Catalogue number Serial number

Medical device

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Symbols

On the packaging/cartridge

This way up

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Permitted temperature range for storage

Keep away from heat

Fragile, handle with care

CE mark

Use by

Keep dry

Medical device

WARNING! Flammable liquid and vapour

“Der Grüne Punkt” (The Green Dot) trademark of Duales System Deutschland GmbH

Consult instructions for use

Trademark of RESY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard

Manufacturer

SDS

EUH210 safety data sheet available on request

Caution! According to Federal law, this medical device may only be sold by or on the order of a dentist, physician or any other medical practitioner licensed by the law of the State in which he or she practices and who intends to use or order the use of this medical device.

1. Introduction For your safety and the safety of your patients Prior to initial use please read the Instructions for use. These explain how to use your medical device and guarantee a smooth and efficient operation. Observe the safety notes. Intended use Unit for cleaning the spray channels and lubricating the moving parts of dental transmission instruments, turbines, air motors and air-driven dental scalers. Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. When transmission instruments are prepared with the medical device, they are neither disinfected nor sterilized. After cleaning of the spray channels and lubrication of the transmission instruments with the medical device, they subsequently need to be disinfected and sterilized.

Qualifications of the user We have based the development and design of the medical device on the target group of dentists, dental hygienists and dental assistants. 7

Introduction Production according to EU Directive The medical device meets the requirements of Regulation (EU) 2017/745 Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when it is used in compliance with the following directions: >> The medical device must be used in accordance with these Instructions for Use. >> The medical device has no components that can be repaired by the user (with exception of replacing the o-rings, cartridges, filter and air filter). Assembly, modifications or repairs must only be undertaken by an authorised W&H service partner. (see page 37) >> Unauthorized opening of the medical device invalidates all claims under warranty and any other claims. Improper use, unauthorized assembly, modification or repair to the medical device, non-compliance with our instructions or the use of accessories and spare parts which are not approved by W&H, invalidates all claims under warranty and any other claims. Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer and the competent authority!

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2. Unpacking Have the Instructions for Use at hand. Take out the white and green funnels.

Take out the service oil, cleaning liquid, suction filter and the optional accessories from the side compartments.

Remove the basic adaptor. Lift out the Assistina in the fibreboard box.

Open the box at the tucked-in closure and remove the air hose from the cover. Remove the initial accessories.

The W&H packaging is environmentally friendly and can be disposed of through specialist recycling organizations. However, we recommend that you keep the original packaging.

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3. Scope of delivery > > > > > > > >

W&H Assistina maintenance unit (REF 00030125, 00030140) Suction filter, complete Basic adaptor REF 02685000 Funnel, white, REF 02689300 Funnel, green, REF 02689400 Air connection hose 2 m, REF 02697000, complete Initial provision of 5 layers of fleece REF 02690300 2 spare seals REF 02680600 and 2 spare O-rings REF 02695700 > Instructions for Use with warranty card

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4. Safety notes Please observe the following instructions under all circumstances >> Only set up the product in suffiently well ventilated rooms! >> Keep the device closed during the maintenance process! GHS02 WARNING! H226 Flammable liquid and vapour >> P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. >> P233 Keep container tightly closed. >> P280 Wear protective gloves / eye protection. >> P403 + P235 Store in a well-ventilated place. Keep cool. >> P 501 Dispose of contens / container in accordance with local / regional / national / international regulations. >> Place the medical device on a flat, level surface.

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5. Description

Front side

Filler hole / storage container for service oil

Filler hole / storage container for cleaning liquid

Button to cleaning / maintenance process

Recess for adaptor

Fill level of service oil

Fill level of c­ leaning liquid

Indicator window for ­service oil

Cover

Waste disposal tray

Indicator window for cleaning liquid

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W&H service oil

W&H cleaning liquid

Description

Rear side

Suction filter

Quick release coupling for compressed air

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6. Start-up > Service oil must be at room temperature when it is poured in. > Never reverse funnels (white to white, green to green) and store them in a dust-free environment! > Check the filling level indicator!

Unscrew the two caps and remove the two transport seals (malfunction!)!

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Start-up Unscrew the cap from the white storage container. Insert the white funnel.

Add 250 ml of cleaning liquid.

Add 250 ml of service oil.

Close the storage containers for the service oil and cleaning liquid.

Unscrew the cap from the green storage container. Insert the green funnel.

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Start-up

General 02697000

Push the quick release coupling of the connecting hose into the coupling socket on the Assistina. Connect the compressed air line.

Fit the suction filter so that it is leak-tight.

The built-in air filter in the connecting hose is only a fine filter. It cannot clean unfiltered and possibly contaminated compressor air. Dirty fine filters must be replaced.

> Use only non-contaminated,oil-free,dry and filtered compressed air according to ISO 7494-2.

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Start-up

Initial filling Pull the drip guard off the maintenance attachment and store it safely. Close the cover.

15 x 2 secs.

Press the start button about 15 times for 2 seconds with a pause of 2 seconds between each actuation.

If no fluid can be seen or detected on the waste disposal tray, the supply lines are not yet completely full.

10 x 2 secs.

Press the start button 10 times for 2 seconds.

> Do not connect any transmission instrument, turbine, air motor or dental scaler during the test! > If the adaptor is fitted on the maintenance attachment, remove it.

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Start-up Place a fleece inlay in the waste disposal tray.

1x 2 secs.

Press the start button once for 2 seconds.

Close the cover and waste disposal tray.

Check that the fleece inlay is damp to ensure correct function. If it is not damp, repeat the process 2 to 3 times. Dispose of saturated fleece inlays as with cloths for surface disinfection. In the event of operating malfunctions (e.g., vibrations, unusual noise, overheating, failure or leakage) stop the medical device immediately and contact an authorized W&H service partner.

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Start-up Function display Continuously monitor the function display! > Press the start button for 2 seconds. A green ball for the cleaning liquid appears in the right-hand window. > Release the start button. A green ball for the service oil appears in the left-hand window. After a few seconds, both balls will drop down again. Correct operation of the maintenance process is indicated by these two function displays. If ever the balls disappear during a program cycle, this indicates a malfunction. Function check of the mechanical drive > Fit a transmission instrument with a rotary instrument inserted onto the Assistina maintenance attachment. > Press the start button for 2 seconds.

The maintenance cycle begins and the rotary instrument turns. If the rotary instrument does not turn, there is a malfunction. 19

7. Operation

Maintenance process

>> Wear protective clothing, saftey glasses, face mask and gloves. >> Refer to the »hygiene and maintenance« instructions in the Instructions for Use of the transmission instruments. Transmission instruments with ISO coupling The maintenance program will be completed in about 35 seconds. > Pull down cover. Press the green release button and pull off the basic adaptor. Keep the adaptor in the recess.

With its spray exit nozzle directed downwards, push the transmission instrument onto the maintenance attachment up to the limit stop. Close the cover and the waste disposal tray. 20

1x 2 sec.

Press the start button once for about 2 seconds. Open the cover at the end of the maintenance cycle.

Press the green release button of the maintenance attachment while at the same time removing the transmission instrument.