W&H Assistina MB-302 User manual

Instructions for Use
MB-302

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Contents
Symbols.......................................................................................................................................................................................................... 4
1. Introduction ............................................................................................................................................................................................... 7
2. Electromagnetic compatibility (EMC)..................................................................................................................................................... 9
3. Unpacking ................................................................................................................................................................................................ 10
4. Scope of delivery..................................................................................................................................................................................... 11
5. Safety notes .............................................................................................................................................................................................12
6. Description ...............................................................................................................................................................................................14
Front panel ...........................................................................................................................................................................................14
LED display ......................................................................................................................................................................................... 15
Quick ISO/Quick RM adaptor (optional accessories)........................................................................................................................ 16
Rear panel ............................................................................................................................................................................................17
7. Start-up..................................................................................................................................................................................................... 18
Inserting/removing a cartridge.......................................................................................................................................................... 18
Inserting/removing a filter................................................................................................................................................................. 19
Connecting/disconnecting the air connection hose ........................................................................................................................ 20
Connecting the power supply unit ..................................................................................................................................................... 20
General ................................................................................................................................................................................................ 20
Switching the Assistina Twin on/off....................................................................................................................................................21
Initial filling ......................................................................................................................................................................................... 22
Standby mode..................................................................................................................................................................................... 24
Test run................................................................................................................................................................................................ 25

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Contents
8. Operation.................................................................................................................................................................................................. 26
General ................................................................................................................................................................................................ 26
Loading/removing of the transmission instruments with ISO connection .............................................................................27 – 28
Loading/removing of the transmission instruments and/or adaptors with fixed RM connection................................................. 29
Maintenance process ......................................................................................................................................................................... 30
Lubrication of the chucking system .................................................................................................................................................. 32
9. Cleaning.................................................................................................................................................................................................... 35
Medical device .................................................................................................................................................................................... 36
Sliding window .................................................................................................................................................................................... 36
Start-up after cleaning........................................................................................................................................................................ 37
10. Maintenance .......................................................................................................................................................................................... 38
Replacing O-rings................................................................................................................................................................................ 38
Replacing the air filter ........................................................................................................................................................................ 39
11. Error messages...................................................................................................................................................................................... 40
12. W&H Accessories and spare parts....................................................................................................................................................... 45
13. Servicing ................................................................................................................................................................................................ 48
14. Technical data........................................................................................................................................................................................ 49
15. Disposal ................................................................................................................................................................................................. 51
Explanation of warranty terms................................................................................................................................................................... 52
Authorized W&H service partners.............................................................................................................................................................. 53

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WARNING!
(risk of injury)
ATTENTION!
(to prevent damage occurring)
General explanations,
without risk to
persons or property
CE mark Do not dispose of with
domestic waste
Symbols in the Instructions for Use

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Consult Instructions
for Use
Date of manufacture
Do not dispose of with domestic
waste
DC – direct current
Supply voltage
of the unit
V
Data Matrix code
for product information
including UDI (Unique
Device Identification)
Catalogue number
Serial number
CE mark
Symbols on the medical device
Medical Device
Manufacturer

6
This way up 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.
Fragile, handle with care
Keep dry
Permitted temperature
range for storage
Humidity,
limitation
CE mark
Keep away from heat
Use by
Permitted temperature
range for transport:
“Der Grüne Punkt” (The Green
Dot) trademark of Duales
System Deutschland GmbH
Trademark of RESY OfW GmbH
for identification of recyclable
transport and outer packaging
of paper and cardboard
Symbols on the packaging/cartridge
Medical Device
Manufacturer
Consult Instructions
for Use

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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 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.
1. Introduction

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Production according to EU Regulation
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 the exception of replacing the O-rings,
cartridges, filter and air filter). Assembly, modifications or repairs must only be undertaken by an authorized W&H service
partner (see page 53).
> The electrical installation at the premises must comply with the regulations laid out in IEC 60364-7-710 (»Installation of
electrical equipment in rooms used for medical purposes«) or with the regulations applicable in your country.
> Unauthorized opening of the equipment invalidates all claims made under warranty and any other claims.
Improper use
Improper use and unauthorized assembly, installation and modification of or repairs to the medical device or failure to comply with
our instructions invalidates all claims under warranty and releases us from all other claims!
Introduction
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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Medical electrical equipment is subject to particular precautions in regard to EMC and must be installed and put into
operation in accordance with the EMC notes included.
W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H
accessories and spare parts. The use of accessories and spare parts not approved by W&H can lead to an increased
emission of electromagnetic interference or to a reduced resistance against electromagnetic interference.
2. Electromagnetic compatibility (EMC)

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W&H packaging is environmentally friendly and can be
disposed of by industrial recycling companies.
However, we recommend that you keep the original packaging.
Remove the cardboard box
with the Twin Care SET.
Lift out the medical device.
eRemove the cardboard box
with the:
> air connection hose;
> power supply unit.
3. Unpacking

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REF Description
REF 30310
REF 02697000
REF 07477500
REF 07484000
optional accessories
REF 06422600
REF 06395100
W&H Assistina Twin (MB-302)
Air connection hose
Power supply unit MB-302
Twin Care SET MB-302:
> W&H Activefluid cartridge, MC-302, 200 ml
> W&H Service Oil F1 cartridge, MD-302, 200 ml
> filter
Quick ISO adaptor
Quick RM adaptor
4. Scope of delivery

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Please observe the following instructions under all circumstances
> Before using the medical device for the first time, store it at room temperature for 24 hours.
> Only set up the product in sufficiently well ventilated rooms!
> Always ensure the correct operating conditions.
> Check the medical device for damage, leakage and loose parts each time before using
(e.g., adaptor, filter compartment cover).
> Always close the sliding window before you use the medical device!
> Keep the medical device closed during the maintenance process!
Power supply unit
> Only use the power supply unit supplied.
> Ensure that the medical device can be disconnected from the power supply at any time.
> Disconnect the medical device in dangerous situations from the power supply.
Pull the power supply out of the socket.
Place the medical device on a flat, level surface.
5. Safety notes

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Process fluids
> If inhaled: Supply fresh air; consult doctor in case of complaints.
> Following contact with skin: Wash off with soap and plenty of water.
> Following contact with eyes: Rinse opened eye for several minutes under running water. If symptoms persist,
consult a doctor.
> If swallowed: If symptoms persist, consult a doctor.
> Only use process fluids which have been approved by the manufacturer.
Approved process fluids
> W&H Activefluid, MC-302
> W&H Service Oil F1, MD-302
Cartridges
> Replace cartridges immediately if they display faults or leak!
> Do not expose the cartridges to direct sunlight!
The cartridge spike in the medical device is sharp.
Be careful not to injure yourself on the projecting spike.
Medical device
The medical device is classed as »conventional equipment« (closed equipment without protection against the ingress of water).
Safety notes

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Operating controls
Quick Connect
by W&H
Cartridge compartment for
W&H Activefluid MC-302
Cartridge compartment for
W&H Service Oil F1 MD-302
Cover cartridge compartment
Sliding window
Left chamber
Right chamber
Air duct
6. Description Front panel

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Start button
W&H Activefluid, MC-302W&H Service Oil F1, MD-302
Right chamberLeft chamber
Description LED display

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Description Quick ISO/Quick RM adaptor (optional accessories)
Quick RM adaptorQuick ISO adaptor
O-rings
Union nut
Release button
O-rings

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Connecting socket for
air connection hose
Connecting socket for
power supply unit
USB port
(for Service only!)
Filter compartment cover
Description Rear panel

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The cartridges must be at room temperature when they are inserted.
The cartridge spike in the medical device is sharp.
Be careful not to injure yourself on the projecting spike.
Remove the cartridge
compartment cover.
Inserting a cartridge.
> Push the cartridge in until
the limit stop is reached.
eRemoving a cartridge.
> Pull out the cartridge.
Replace the cartridge
compartment cover.
Whenever you replace a cartridge:
> always clean the cartridge compartment,
> perform the initial filling.
Observe the manufacturer’s instructions on the use of disinfectant.
7. Start-up Inserting/removing a cartridge

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eClose the filter
compartment cover.
Open the filter
compartment cover.
Inserting/removing a filter.
> Push the filter in until the
limit stop is reached.
> Pull out the filter.
Always clean the filter compartment whenever you replace a filter.
Observe the manufacturer’s instructions on the use of disinfectant.
Start-up Inserting/removing a filter

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Connecting/disconnecting the air connection hose
Connect the air connection hose.
Disconnect the air connection hose.
Use only non-contaminated, oil-free, dry and filtered compressed air according to ISO 7494-2.
Replace the filter if contaminated.
Connecting the power supply unit
eConnect the power supply unit to the medical device.
Start-up General