W&H piezomed PLUS SA-435 M User manual

Instructions for Use
SA-435 M
SA-430 M

2
Contents
Symbols.......................................................................................................................................................................................................... 4
1. Introduction ............................................................................................................................................................................................... 7
2. Unpacking .................................................................................................................................................................................................. 9
3. Scope of delivery .................................................................................................................................................................................... 10
4. Safety notes ............................................................................................................................................................................................ 11
5. Description............................................................................................................................................................................................... 16
6. Start-up .................................................................................................................................................................................................... 19
7. Operation .................................................................................................................................................................................................. 23
8. Icons......................................................................................................................................................................................................... 26
9. Error messages........................................................................................................................................................................................ 29
10. Hygiene and maintenance ................................................................................................................................................................... 31
General notes...................................................................................................................................................................................... 31
Limitations on processing.................................................................................................................................................................. 32
Initial treatment at the point of use .................................................................................................................................................. 33
Manual cleaning.................................................................................................................................................................................. 34
Manual disinfection............................................................................................................................................................................ 35
Automated cleaning and disinfection ............................................................................................................................................... 36
Drying.................................................................................................................................................................................................. 37
Inspection, maintenance and testing ............................................................................................................................................... 38
Packaging............................................................................................................................................................................................ 39
Sterilization......................................................................................................................................................................................... 40
Storage ................................................................................................................................................................................................ 42
11. Service ................................................................................................................................................................................................... 43
12. W&H accessories and spare parts....................................................................................................................................................... 45
13. Technical data........................................................................................................................................................................................ 47

3
Contents
14. Data on electromagnetic compatibility according to IEC/EN 60601-1-2.......................................................................................... 49
15. Disposal ................................................................................................................................................................................................. 53
W&H course certificate............................................................................................................................................................................... 54
Explanation of warranty terms................................................................................................................................................................... 57
Authorized W&H service partners.............................................................................................................................................................. 58

4
Symbols in the Instructions for Use
WARNING!
(risk of injury)
ATTENTION!
(to prevent damage occurring)
General explanations, without risk to
persons or objects
Sterilizable up to
the stated temperature
Thermo washer disinfectable Type B applied part
(not suitable for intracardiac
application)

5
Symbols on the medical device
Follow Instructions for Use
Date of manufacture
Catalogue number
Serial number
Electric voltage (volt)
Frequency (hertz)
DataMatrix Code for product
information including UDI
(Unique Device Identification)
Foot control
Do not dispose of with
domestic waste
MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005,
ANSI/AAMI ES60601-1: A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012,
CAN/CSA-C22.2 No. 60601-1:2008, CSA CAN/CSA-C22.2 NO. 60601-1:2014.
25UX – Control No.
25UX
CE marking with
identification number of
the Notified Body
XXXX
Manufacturer
DC – direct current

6
Symbols on the packaging
This way up
Caution! Federal law restricts
this device to sale by or on the
order of a physician, dentist,
veterinarian or with the
descriptive designation of any
other practitioner licensed by
the law of the State in which the
practitioner practices to use or
order the use of the device.
Fragile, handle with care
Keep dry
Temperature limitation
Humidity limitation
“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.
-40 °C (-40°F) Min.
+70 °C (+158°F) Max.
8 %
80 %
CE marking with identification
number of the Notified Body
XXXX
Data structure in accordance
with Health Industry Bar Code
DataMatrix Code for product
information including UDI
(Unique Device Identification)
Catalogue number
Serial number
MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005,
ANSI/AAMI ES60601-1: A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012,
CAN/CSA-C22.2 No. 60601-1:2008, CSA CAN/CSA-C22.2 NO. 60601-1:2014.
25UX – Control No.
25UX
Manufacturer
Date of manufacture

7
1. Introduction
For your safety and the safety of your patients
These Instructions for Use explain how to use your medical device. 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.
Observe the safety notes.
Intended use
Drive unit with a piezoceramic oscillating system for treatment of organic hard and soft tissue in dental surgery, implantology,
maxillofacial surgery and periodontics.
Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties.
Qualifications of the user
Only suitably qualified medical, technical and specialist trained staff may use the medical device. We have based our development
and design of the medical device on the physician target group.

8
Introduction
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.
> Modifications or repairs must only be undertaken by an authorised W&H service partner (see page 58).
> 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 medical device invalidates all claims under warranty and any other claims.
Improper use, unauthorized assembly, modification of or repairs to the control unit or the handpiece with cable and non-compliance
with our instructions or the use of accessories and spare parts unauthorized by W&H will void the warranty and release us from all
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
Remove the carton.
Lift out the insert with the
stand, Instructions for Use,
universal support, control
unit and mains cable.
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 packaging and
remove the power supply,
irrigation tubing set and
accessories.

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3. Scope of delivery
Control unit 30406000 30407000
REF 08072750 Irrigation tubing set 2,2 m
incl. Y-manifold (6 pcs. disposable) X
REF 07883900 Power supply X
REF 07721800 Universal support X
REF 08067690 Stand X
Mains cable country-specific X
Optional included in set
REF 30392000 Handpiece SA-40 L with 1,8 m cable (only for SA-435 M)
REF 30392001 Handpiece SA-40 L with 3,5 m cable (only for SA-435 M)
REF 30408000 Handpiece SA-40 with 1,8 m cable (only for SA-430 M)
REF 06369001 Nozzle cleaner
REF 30264000 Foot control S-NW
REF 30285000 Foot control S-N2
REF 06276700 Instrument changer