W&H piezomed SA-320 User manual

Instructions for Use
SA-320

2
Contents
Symbols.......................................................................................................................................................................................................... 4
1. Introduction ............................................................................................................................................................................................... 8
2. Electromagnetic compatibility (EMC)................................................................................................................................................... 10
3. Unpacking ................................................................................................................................................................................................ 11
4. Scope of delivery......................................................................................................................................................................................12
5. Safety notes .............................................................................................................................................................................................13
6. Description............................................................................................................................................................................................... 19
of front panel....................................................................................................................................................................................... 19
of rear panel........................................................................................................................................................................................ 20
Foot control S-N1/S-NW.......................................................................................................................................................................21
Handpiece with cable.......................................................................................................................................................................... 23
7. Start-up..................................................................................................................................................................................................... 24
8. Instruments ............................................................................................................................................................................................. 27
Insert/remove .................................................................................................................................................................................... 27
9. Setup settings ......................................................................................................................................................................................... 28
Control unit.......................................................................................................................................................................................... 28
Foot control S-N1................................................................................................................................................................................ 29
Volume................................................................................................................................................................................................. 30
Reset factory settings........................................................................................................................................................................ 31
10. Operation................................................................................................................................................................................................ 32
Changing the program (P1 – P3)....................................................................................................................................................... 33
Changing power .................................................................................................................................................................................. 34
Changing the coolant flow.................................................................................................................................................................. 35
Changing the operating mode............................................................................................................................................................ 36
11. Factory settings .................................................................................................................................................................................... 37

3
Contents
12. Error messages...................................................................................................................................................................................... 38
13. Emergency mode................................................................................................................................................................................... 40
14. Hygiene and maintenance ................................................................................................................................................................... 42
General notes...................................................................................................................................................................................... 42
Limitations on processing.................................................................................................................................................................. 43
Initial treatment at the point of use .................................................................................................................................................. 44
Manual cleaning.................................................................................................................................................................................. 45
Manual disinfection............................................................................................................................................................................ 48
Automated cleaning and disinfection ............................................................................................................................................... 49
Drying.................................................................................................................................................................................................. 50
Inspection, maintenance and testing ............................................................................................................................................... 51
Packaging............................................................................................................................................................................................ 52
Sterilization......................................................................................................................................................................................... 53
Storage ................................................................................................................................................................................................ 55
15. Service ................................................................................................................................................................................................... 56
16. W&H accessories and spare parts....................................................................................................................................................... 58
17. Technical data ........................................................................................................................................................................................ 60
18. Disposal ................................................................................................................................................................................................. 62
W&H course certificate............................................................................................................................................................................... 64
Explanation of warranty terms .................................................................................................................................................................. 67
Authorized W&H service partners.............................................................................................................................................................. 68
Open Source Software................................................................................................................................................................................. 69
Manufacturer’s declaration......................................................................................................................................................................... 70

4
Symbols
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
in the Instructions for Use
Suitable for ultrasonic bath
Type B applied part (not suitable for
intracardiac application)

5
Symbols
Follow Instructions for Use Class II equipment
Date of manufacture
Catalogue number
Serial number
Alternating current
Power consumption of the
control unit
Electric fuse
Supply voltage
Supply current
Frequency of the alternating
current
DataMatrix Code for product
information including UDI
(Unique Device Identification)
Foot control
Do not dispose of with
domestic waste
On / Off
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
on the control unit
Earth
Medical Device
Manufacturer

6
Symbols
This way up
Caution!
Federal law restricts this device
to sale by or on the order of a
dentist, physician, 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
-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)
on the packaging
Catalogue number
Serial number
Manufacturer
Date of manufacture
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
Medical Device
Trademark of RESY OfW GmbH for
identification of recyclable transport
and outer packaging of paper and
cardboard

7
Symbols
Sterilization with ethylene
oxide
Caution!
Federal law restricts this device to sale by or on the order of a dentist,
physician, 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.
Batch code
Not for re-use Latex-free
Use by
CE marking
with identification number
of the Notified Body
XXXX
on the irrigation tubing set
Catalogue number Manufacturer
Do not resterilize Do not use when package is
damaged
Keep away from heat
DataMatrix Code for product
information including UDI
(Unique Device Identification)
Data structure in accordance
with Health Industry Bar
Code

8
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.

9
Introduction
Production according to EU Directive
The medical device meets the requirements of Directive 93/42/EEC.
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 authorized W&H service partner (see page 68).
> 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.
In addition to unauthorized assembly, installation, modification of or repairs to the control unit and non-compliance with our
instructions, improper use 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. Electromagnetic compatibility (EMC)
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.
HF communications equipment
Portable HF communications equipment (including peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to the medical device. Otherwise, degradation of the performance of this medical
device could result.
The medical device may be interfered by other equipment, even if these other devices comply with CISPR (International
special committee on radio interference) emission requirements.
Use of this medical device adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this medical device and the other equipment should be observed to verify that
they are operating normally.
The medical device is not intended for use in the vicinity of HF surgical devices.

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3. Unpacking
Lift out the insert with the
stand and the foot control.
Lift out the insert with the
control unit.
Remove the irrigation
tubing set.
Remove the carton
containing the accessories
supplied.
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 sterilization
cassette.

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4. Scope of delivery
Control unit 30078000 30078001 30078003 30078004 30078005 30078006 30078007
REF 06985000 Handpiece with 1.8 m cable X X X X
REF 07159200 Handpiece with 3.5 m cable X X X
REF 07004400 Foot control S-N1 X X
REF 30264001 Foot control S-NW X X
REF 07795800 SPI dongle XXXX
REF 04653500 Handle for foot control X X X X
REF 436360 Irrigation tubing set 2.2 m
(3 pcs, disposable item) X X X X
REF 436410 Irrigation tubing set 3.8 m
(3 pcs, disposable item) X X X
REF 07172900 Sterilization cassette XX XXXX
REF 07173100 Instrument set “Bone“XX XXXX
REF 07721800 Universal support X
REF 04005900 Stand X
REF 06276700 Instrument changer X
REF 00636901 Nozzle cleaner X
Mains cable country-specific X

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5. 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 when the medical device 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.
> Do not look directly into the light source.
> Avoid overheating at the treatment site.
> Ensure that it is possible to complete the operation safely should the units or instruments fail.
> Only put the handpiece with cable into operation when the handpiece sleeve is attached.
> The responsibility for the use and timely shutdown of the system lies with the user.
> If the LED fails, change the LED socket.
> Only change the LED socket when the handpiece is stationary.
> Always operate the handpiece with the LED socket fitted.
The medical device is not approved for operation in potentially explosive atmospheres.
Do not twist or kink the cable! Do not coil it too tightly!

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Safety notes
> Use only original W&H fuses.
> Never touch the patient and the electrical contacts on the medical device simultaneously.
The control unit is classed as ”conventional equipment” (closed equipment without protection against the ingress of water).
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 switch
> Only use the mains cable supplied.
> Plug the mains cable only into a power socket with protective contact.
> Set up the control unit so the power switch is easily accessible.
Disconnect the medical device in dangerous situations from the power supply!
> Pull the power supply out of the socket.

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Safety notes
Instruments
> Only use instruments approved by W&H and the associated instrument changer.
> Make sure that the instrument used complies with the instrument group displayed.
> An overview for the correct power setting is included with each instrument.
> Ensure that the original shape of the instrument is not changed (e.g. by dropping).
> Instruments must not be bent back to shape or reground.
> Only insert the instrument when the handpiece is at rest.
> Never touch the instrument when vibrating.
> Remove the instrument from the handpiece after every treatment and place it in the instrument stand (provides
protection against injury and infection).
> Ensure there is sufficient coolant directly at the treatment site.
> The instruments Z25P and Z35P may only be operated with a coolant setting of max. 50%.
> Keep the handpiece moving at all times when operating the instrument.
> Do not exert too much pressure on the instrument. This can cause the instrument to heat up or break, resulting in
injury to the patient.
> Do not make any levering motions with the instrument.
> Never let the instrument run freely without coolant.

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Safety notes
Risks due to electromagnetic fields
This handpiece with cable complies with the reference values defined in EN 50527-2-1/2016 for active implantable medical
devices (AIMD) and cardiac pacemakers.
The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillators (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 control unit and the cardiac pacemaker or ICD of at
least 30 cm (11,8 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.

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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 national laws, directives, standards and guidelines for disposal.

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Hygiene and maintenance prior to initial use
> Clean the control unit.
> Clean and disinfect the handpiece with cable, the universal support, the stand, the instruments and the instrument
changer.
> Sterilize the handpiece with cable, the universal support, the instruments and the instrument changer.
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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6. Description of front panel
Shift buttons
PLUS / MINUS buttons
Connection for handpiece
Pump cover
OPEN
Pump cover Stand holder
Display

20
Description of rear panel
Power
socket Fuse holder with 2 fuses
REF 06661800 (250 V – T1,25AH)
Power switch
I / O (ON / OFF)
Stand holder
Connecting socket
for foot control