W&H assistina MB-300 User manual

Instructions for use
3x3 (MB-300)
3x2 (MB-200)

2
W&H Symbols..................................................................................................................................................................................5 – 7
1. Introduction..................................................................................................................................................................................8 – 10
2. Electromagnetic compatibility (EMC) .............................................................................................................................................. 11
3. Unpacking............................................................................................................................................................................................12
4. Scope of delivery.................................................................................................................................................................................13
5. Safety notes...............................................................................................................................................................................14 – 15
6. Description ................................................................................................................................................................................. 16 – 21
> Front panel and LED displays (16)
> External cleaning ring for Assistina 3x3 (17)
> RM/ISO adaptor (18)
> Process chamber (19)
> Cartridge compartment (20),
> Rear panel (21)
7. Starting operation...................................................................................................................................................................... 22 – 29
> Insertion/removal of a cartridge (22)
> Insertion/removal of an external cleaning ring (23 – 24)
> Connection/disconnection of the air connecting hose (25)
> Connection of the mains cable (26)
> Switch on / switch off Assistina (26)
> Initial filling (27)
> Standby mode (28)
> Test run (29)
Contents

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Contents
8. Hygiene and maintenance........................................................................................................................................................30 – 36
> General information (30)
> Description of the process (31)
> Description of the adaptors (32)
> Connection/disconnection of the adaptors (33)
> Loading/removing transmission instruments with ISO and Roto Quick connections (34)
> Loading/removing transmission instruments with a fixed RM connection (35)
> Preparation process (with time indication) (36)
9. Cleaning and disinfection .........................................................................................................................................................37 – 40
> Device and RM/ISO adaptor (37 – 38)
> Waste drawer, cover, external cleaning ring (39)
> Start-up after cleaning and disinfection (39 – 40)
10. Maintenance...............................................................................................................................................................................41 – 43
> Emptying the waste drawer (41)
> Replacing O-rings (42)
> Replacing the air filter (43)

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11. Error messages..........................................................................................................................................................................44 – 48
12. W&H Accessories ........................................................................................................................................................................49 – 51
13. Servicing ..............................................................................................................................................................................................52
14. Technical data............................................................................................................................................................................53 – 54
15. Recycling and disposal ......................................................................................................................................................................55
Explanation of warranty terms ....................................................................................................................................................................56
Authorized W&H service partners................................................................................................................................................................ 57
Contents

5
W&H Symbols
WARNING!
(risk of injury)
ATTENTION!
(to prevent damage occurring)
General explanations,
without risk to persons or objects
Symbols in the instructions for use
W&H ServiceSterilizable up to the
stated temperature

6
W&H symbols
Symbols on the device
Consult instructions
for use
Date of manufacture
Catalogue number
REF
Serial number
SN
Do not dispose of with
domestic waste
Alternating current
AC
VA Electric power input of the unit
Supply voltage of the unit
V
Supply current
A
Frequency of the alternating
current
Hz
Data matrix code for product
identification e.g. for hygiene/
maintenance processes

7
W&H symbols
This way up
Symbols on the packaging / cartridges
Federal law restricts this
device to sale by or on the
order of a dentist,
physician or any other
practitioner licensed by the
law of the state in which he
or she practices to use or
order the use of the device.
Temperature limit
for storage
Fragile, handle with care
Keep away from rain Humidity limitation
CE from
manufacturer
»Der Grüne Punkt«
Identification mark of Duales
System Deutschland AG
Keep away from
sunlight
Use by
R
E Y
General symbol for recovery/
recyclable
Temperature limit
for transport

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For your safety and the safety of your patients
These instructions explain how to use your W&H product. However, we must also warn against possible hazardous
situations. Your safety, the safety of your team and, of course, the safety of your patients, are of paramount importance
to us.
It is therefore essential that you observe the safety notes on pages 14 – 15.
Intended use
The unit is a cleaning- and lubrication device for dental transmission instruments (especially straight- and contra angle handpieces,
turbines, airdriven scalers and airmotors).
Misuse may damage the Assistina unit and hence cause risks and hazards for users and third parties.
When transmission instruments are prepared with the Assistina unit, they are neither disinfected nor sterilized.
After cleaning and lubrication of the transmission instruments with the Assistina unit, they subsequently need to be
disinfected and sterilized.

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Introduction
Qualifications of the user
The Assistina unit is only intended for qualified use in dental medicine according to the applicable health and safety regulations
and accident prevention measures, and with full compliance with these operating instructions. The Assistina must only be prepared
and maintained by persons who have been instructed in infection protection, self-protection and patient safety. Improper use (e.g.
due to lack of hygiene or appropriate maintenance), non-compliance with our instructions or the use of accessories and spare
parts which have not been approved by W&H will invalidate all claims made under warranty or otherwise.
Production according to EU Directive
EU Directive 93/42/EEC has been used as a basis in the design and manufacture of this medical device and it applies to
the dental surgical units
> W&H Assistina 3x3 (external cleaning, internal cleaning and lubrication for up to 3 transmission instruments)
> W&H Assistina 3x2 (internal cleaning and lubrication for up to 3 transmission instruments)
in the condition as supplied by us. This declaration does not apply to non-specified fittings, mountings etc.

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Introduction
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of the Assistina unit when it is
used in compliance with the following directions:
> The Assistina unit must be used in accordance with these instructions for use.
> The Assistina unit has no components which can be repaired by the user (except replacing O-rings and the air filter).
Assembly, modifications or repairs must only be undertaken by an authorized W&H service partner (see page 57).
> The electrical installation at the premises must comply with the regulations of 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.

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2. Electromagnetic compatibility (EMC)
Notes on electromagnetic compatibility (EMC)
Medical electrical equipment is subject to particular precautions with respect to EMC and must be installed and put into
operation in accordance with the included EMC instructions.
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 other accessories/spare parts can lead to increased emissions of electromagnetic interference
or to a reduced resistance against electromagnetic interference.

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3. Unpacking
W&H packaging is environmentally friendly and can be
disposed of by industrial recycling companies.
However, we recommend that you keep the original
packaging.
Take out the carton containing the
> Mains cable
> Adaptor
> Air connection hose
> External cleaning ring (Assistina 3x3).
Lift out the device.> Take out the carton with
cartridge W&H Service Oil
F1, MD-200.
> Remove the spacer.
Take out the carton with
cartridge W&H Activefluid,
MC-1100.

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4. Scope of delivery
After unpacking, you should have the following parts:
W&H Assistina 3x3 (MB-300) REF 19923000
RM/ISO adaptor REF 06257600
Air connection hose (2 m), REF 06700100
W&H Service Oil F1, MD-200 REF 06691500
W&H Activefluid, MC-1100 REF 06691600
External cleaning ring REF 06692700
W&H Assistina 3x2 (MB-200) REF 19922000
RM/ISO adaptor REF 06257600
Air connection hose (2 m), REF 06700100
W&H Service Oil F1, MD-200REF 06691500
W&H Activefluid, MC-1100 REF 06691600
Mains cable for W&H Assistina 3x3 / 3x2
REF 01343700 (EU)
or:
REF 02821400 (USA, CAN, J) / REF 03212700 (UK, IRL) / REF 02909300 (AUS, NZ) / REF 04280600 (CH) /
REF 05901800 (DK)
Optional for W&H Assistina 3x3 / 3x2
Adaptor for all W&H products with Roto Quick System, REF 02690400

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5. Safety notes
Please observe the following instructions under all circumstances
> Before using the Assistina for the first time, store it at room temperature for 24 hours.
> Always place the Assistina unit on a flat, level surface.
> Only set up the device in a sufficiently well ventilated room.
>Always ensure that the correct operating conditions are provided.
> Before every use, check the device for damage, leaks and loose parts (e.g. adaptor, cover, external cleaning ring).
> Before starting to use the device, always close the cover and waste drawer.
>Keep the device closed during the preparation process.
Inappropriate use
In addition to incorrect assembly, installation, modification or repairs to the Assistina unit or failure to comply with our
instructions invalidates all claims under warranty and any other claims.
Mains cable
Only use the mains cable supplied.
Set up the device so that the power cable is easily accessible.
In dangerous situations, the device can be disconnected from the power supply using the power cable.
Device
The device is classed as »conventional equipment« (closed equipment without protection against the ingress of water).

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Safety notes
Process fluids
> After inhalation: Supply fresh air; consult doctor in case of complaints.
> After skin contact: Wash off with soap and plenty of water.
> After eye contact: Rinse opened eye for several minutes under running water.
If symptoms persist, consult a doctor.
> After swallowing: If symptoms persist, consult a doctor.
> Only use process fluids which have been approved by the manufacturer.
Approved process fluids
> W&H Activefluid, MC-1100
> W&H Service Oil F1, MD-200
Cartridges
> Replace a faulty or leaking cartridge immediately.
> Protect the cartridges against direct sunlight.
The cartridge spike in the device is sharp.
Be careful not to injure yourself on the projecting spike.
External cleaning ring
Risks due to magnetic fields
The functionality of implantable systems, such as cardiac pacemakers and ICD (implantable cardioverter defibrillator)
can be affected by magnetic fields.
> Keep the external cleaning ring away from implanted devices.

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Waste drawer
Operating controls
Cover
Sliding lock for the cover
6. Description – front panel and LED displays
»Start« LED»Start« button
Cover Waste drawer
W&H Service Oil F1,
MD-200
W&H Activefluid,
MC-1100
Operating controls/LED displays
Handle

17
Connecting hose
Description – external cleaning ring for Assistina 3x3
Magnetic holder
Cleaning nozzle

18
Description – RM/ISO adaptors
Seal
Release button
O-rings

19
Description – process chamber
Care attachment
(moveable) for 3
transmission instruments
Union nut
Hose guide
Discharge
Sensor
Outlet air
opening
Connecting bush
for external cleaning ring
(3x3)
Cover seal

20
Description – cartridge compartment
Cartridge spike
Cartridge compartment
for W&H Service Oil F1,
MD-200
Button for
releasing the
cartridges
Cartridge compartment for
W&H Activefluid, MC-1100