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

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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.

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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

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4. Safety notes
> Before using the medical device for the first time, store it at room temperature for 24 hours.
> Check the medical device for damage and loose parts each time before using.
> Do not operate the medical device if it is damaged.
> Check the parameter settings every time you restart.
> In case of coolant supply failure, the medical device must be stopped immediately.
> Perform a test run each time before using.
> Avoid overheating at the treatment site.
> The responsibility for the use and timely shutdown of the system lies with the user.
> Ensure that it is possible to complete the operation safely should the units or instruments fail.
> Never touch the patient and the electrical contacts on the medical device simultaneously.
> Make sure that no computer viruses are transferred to the control unit by an external data medium (USB stick).
The medical device is classed as “conventional equipment” (closed equipment without protection against the ingress
of water).
The medical device is not approved for operation in potentially explosive atmospheres.

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Safety notes
Power failure
In the event of a power failure, if the control unit is switched off, or when switching between programs, the last values set
are saved and re-activated on power-up.
System failure
A total system failure does not constitute a critical fault.
Mains cable/Power supply
> Only use the power mains cable/supply supplied.
> Plug the mains cable only into a power socket with protective contact.
Disconnect the medical device in dangerous situations from the power supply!
> Pull the power plug/power supply out of the socket.

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Safety notes
Risks due to electromagnetic fields
The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillator (ICD)
can be affected by electric, magnetic and electromagnetic fields. This medical device is suitable for use on patients with
unipolar and bipolar pacemakers or ICD, if a safety distance between the medical device and the cardiac pacemaker or ICD
of at least 40 cm (15.75 inch) is maintained.
> Find out if patient or user have implanted systems before using the medical device and consider the application.
> Weigh the risks and benefits.
> Make appropriate emergency precautions and take immediate action on any signs of ill-health.
> Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac pacemaker
or ICD.
Foot control
Follow the directions and safety notes in the Instructions for Use of the foot control.
Foot control S-NW
Keep the ORANGE button pressed to switch between the control units.

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Safety notes
Coolant supply
The medical device is designed for use with physiological saline solution.
> Always ensure the correct operating conditions and cooling function.
> Use only suitable coolants and follow the manufacturer’s medical data and instructions.
> Use the W&H irrigation tubing set or accessories approved by W&H.
Irrigation tubing set
> Sterile disposable irrigation tubing sets are supplied with the equipment.
> Note the expiration date and only use disposable irrigation tubing with undamaged packaging.
> Replace the disposable irrigation tubing immediately after every treatment.
> Follow your local and country-specific laws, directives, standards and guidelines for disposal.
Change application
When changing the application a acoustic signal sounds (risk of injury).

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Hygiene and maintenance prior to initial use
> Clean the control unit.
> Clean and disinfect the universal support and the stand.
> Sterilize the universal support.
Test run
Do not hold the handpiece with cable at eye level!
> Attach the handpiece with cable to the control unit.
> Insert the instrument.
> Put the control unit into operation.
In the event of operating malfunctions (e.g., vibrations, unusual noise, overheating, coolant failure or leakage) stop the
medical device immediately and contact an authorized W&H service partner.
Safety notes

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5. Description
Connection for handpiece
Stand holder
SA-430 M / SA-435 M
Connection
for foot control
Connection
for power supply
Connection cable

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Description
ORANGE
Locator
attach/detach
GREEN
GREY
Start motor (pedal)
VARIABLE or ON/OFF
(Factory setting = ON/OFF)
YELLOW
foot control S-N2/S-NW

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Description of foot control S-N2 / S-NW
ORANGE
S-N2/S-NW: Change program
Press the ORANGE button to change programs in ascending order.
When changing from the last program to the first program a longer acoustic signal sounds (risk of injury).
S-NW: Switching between multiple control units
Press the ORANGE button for 3 seconds.
S-NW: Change application
Press the ORANGE button for 3 seconds until an acoustic signal sounds.
S-N2: Change application
Press the ORANGE button for 3 seconds until an acoustic signal sounds.
GREEN
Press the green button to change the coolant volume in steps of 20%
Press and hold the GREEN button to activate the coolant filling function.
YELLOW
Boost function
Press and hold the YELLOW button to activate the boost function.
The boost function increases the power to 100% for 15 seconds.

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6. Start-up
Attach the control unit until it
engages.
Connect the connection
cable to the SI-10xx foot
control connection.
Connect the power supply,
foot control or dongle to the
SA-4xx M.
Pay attention to the
positioning!
Connect handpiece cable.
Pay attention to the
positioning!
Insert the stand.
Pay attention to the
positioning!
Place the medical device on a flat level surface.
Ensure that the medical device can be disconnected from the power supply at any time.

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Start-up
Insert the irrigation tubing.
> Open the pump cover (a,b).
> Insert the irrigation
tubing (c).
> Close the pump cover (d).
Attach the universal support
and lock it.