W&H piezomed classic User manual

Instructions for Use
Handpiece with cable
SA-40 / SA-40 L

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Symbols....................................................................................................................................................................................4
1. Introduction .........................................................................................................................................................................7
2. Safety notes ...................................................................................................................................................................... 10
3.Description ......................................................................................................................................................................... 15
4. Instruments ....................................................................................................................................................................... 16
Insert...................................................................................................................................................................................................16
Remove ..............................................................................................................................................................................................17
5. Hygiene and maintenance................................................................................................................................................ 18
General notes..................................................................................................................................................................................... 18
Limitations on processing................................................................................................................................................................ 20
Initial treatment at the point of use..................................................................................................................................................21
Manual cleaning ................................................................................................................................................................................ 22
Automated cleaning and disinfection.............................................................................................................................................. 27
Drying ................................................................................................................................................................................................ 29
Contents

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Inspection, maintenance and testing.............................................................................................................................................. 30
Packaging .......................................................................................................................................................................................... 32
Sterilization........................................................................................................................................................................................ 33
Storage............................................................................................................................................................................................... 35
6. Servicing ............................................................................................................................................................................36
7. W&H accessories and spare parts................................................................................................................................... 37
8. Technical data....................................................................................................................................................................38
9. Disposal .............................................................................................................................................................................40
Explanation of warranty terms............................................................................................................................................. 41
Authorized W&H service partners........................................................................................................................................42

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Do not dispose of with
domestic waste
General explanations,
without risk to
persons or objects
ATTENTION!
(to prevent damage
occurring)
WARNING!
(risk of injury)
Symbols in the Instructions for Use
Suitable for
ultrasonic bath

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Symbols on the medical device / on the packaging
Catalogue number
CE marking with
identification number of the
Notified Body
DataMatrix Code for
product information
including UDI (Unique
Device Identification)
Serial number
Data structure in
accordance with Health
Industry Bar Code
Thermo washer
disinfectable
Sterilizable up to
the stated temperature
Manufacturer
Date of manufacture
Batch code
XXXX
Type B applied part (not
suitable for intracardiac
application)

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Symbols on the medical device / on the packaging
UL Component
Recognition Mark indicates compliance with
Canadian and U.S. requirements
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.
Temperature limitation
-40 °C (-40°F) Min.
+70°C (+158°F) Max.
Humidity limitation
8 %
80 %

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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
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.
1. Introduction

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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.
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. Only the components approved by the
manufacturer may be replaced (LED socket).
> Unauthorized opening of the medical device invalidates all claims under warranty and any other claims.

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Skilled application
The medical device is intended only for skilled application according to the intended use as well as in compliance
with the valid health and safety at work regulations, the valid accident prevention regulations and in compliance with
these Instructions for Use.
The medical device should be prepared for use and maintained by staff who have been trained in procedures for
infection control, personal safety and patient safety.
Improper use, (e.g., through poor hygiene and maintenance), non-compliance with our instructions or the use of
accessories and spare parts which are not approved by W&H, invalidates all claims under warranty and any 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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> 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.
> Only put the medical device into operation when the handpiece sleeve is attached.
> Avoid overheating at the treatment site.
> 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.
> Do not look directly into the light source.
> Perform a test run each time before using.
> Do not twist or kink the cable! Do not coil it too tightly!
2. Safety notes