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!

10
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.