User’s manual
2 / 12 – User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D
Fig. / Abb. 1
User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D - 3 / 12
This document is an English translation of the original French version.
Reference J12820 version V4 and drawing number NO40FR050D
4 / 12 – User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D
User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D - 5 / 12
ASSOCIATED DOCUMENTATION
This document must be used in association with the following documents:
Document title
References
Consulting electronic user instructions
J00007
Implant Center 2 user’s manual
I27200
Piezotome 2 user’s manual
I57420
Piezotome Solo user’s manual
I57500
ELECTRONIC DOCUMENTATION
The user instructions for your device are available in electronic format on the specified website and not in printed
format. If the website is unavailable, try again later. You can also request a free printed copy of the user
instructions within seven days via our website, by telephone or in writing.
The electronic user instructions are available in PDF format (Portable Document Format). You will need to have a
PDF file reader installed to read the electronic user instructions. It is important for you to have read and
understood thecontent of the user instructions relating to the use of your device and its accessories.
Never use your device without first reading the user instructions.
The device user instructions can be consulted at the following addresses: www.satelec.com/documents
When you receive your device, you are asked to print and/or to download all documents or sections of documents
that you may need to refer to in the event of an emergency, if you are unable to connect to the internet or if
your electronic display tool is not working (computer, tablet, etc.). We recommend that you visit the website
regularly to consult and to download the latest version of your device's user instructions. Users are asked to keep
documentation close at hand for reference when necessary.
6 / 12 – User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D
The P
IEZOTOME
LED handpiece is equipped with a piezoelectric transducer.
It has a light function for optimal lighting of the procedure site.
This light function is achieved by a LED ring consisting of high-performance LEDs, giving a considerably longer
life than conventional optical fiber or bulb technologies.
In addition to the performance of its piezoelectric transducer and its optical properties, the front part of the
P
IEZOTOME
LED handpiece can be completely disassembled for optimal cleaning and sterilizing.
I - INS
T
ALL
ATION
1. 1 PIEZOTOME LED HANDPIECE-CORD
ASSEMBLY CONNECTION
(Please refer to P
IEZOTOME
unit user's manual)
- Align the mark on the cord connector with the mark on the left-hand or right-hand socket of the unit.
- Insert the connector in the socket until you hear the
"click".
1. 2 TIPS MOUNTING
The P
IEZOTOME
LED handpiece is a high technology instrument requiring precautions for its use. The tips must be
screwed and moderately tightened (¼ turn) by means of the P
IEZOTOME
specific wrench or the universal wrench
of Satelec (Fig. 1).
CAUTION
: Correct tip vibration requires perfect tightening without overtorquing beyond the thrust point.
Remove the tip after each procedure to avoid self-jamming.
User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D - 7 / 12
II - MAINTENANCE
Precaution
: rinse the water circuit of the P
IEZOTOME
LED handpiece-insert assembly under running water for 20 to
30 seconds after each use.
Caution
: do not connect the P
IEZOTOME
LED handpiece- cord assembly from the unit when the instrument is
powered and the control pedal is activated.
2. 1 MAINTENANCE OF THE PIEZOTOME LED HANDPIECE-CORD ASSEMBLY
(Fig. 2)
a) Pre-disinfection/cleaning of t h e P I E Z O T O M E
LED handpiece-cord assembly
The P
IEZOTOME
LED handpiece-cord assembly must
not be cleaned in an ultrasonic bath.
Disconnect the P
IEZOTOME
LED handpiece-cord assembly from the unit and remove the insert.
Remove the tip at the front of the P
IEZOTOME
handpiece
(Fig. 2-A).
The front part of the P
IEZOTOME
LED handpiece can be unscrewed, for easier access to the threading and
efficient and easy cleaning, using a cotton swab soaked with alcohol.
Remove the optical guide from inside the P
IEZOTOME
LED handpiece nose (Fig. 2-A).
Disconnect the l i g ht r i n g f r o m the P
IEZOTOME
LED
handpiece, pulling it gently (Fig. 2-A).
Clean and disinfect the body and cord, using cleaning
/ disinfecting towelettes with alcohol, amphoteric and biguanide base (S
EPTOL
™ type towelette) ready for use
(refer to the manufacturer's instructions), for at least two minutes, paying particular attention to the screw
thread cavity; the nose; and the optical guide and LED ring.
Allow the product to act for at least 15 minutes.
Use towelettes that bear the EC marking, or that are in compliance with any standard required under the
applicable national regulations.
b) Pre-disinfection / cleaning of the tip
Pre-disinfection / chemical cleaning
To be carried out immediately after treatment, wearing gloves.
Immerse the tip in an ultrasonic bath (enzymatic, quaternary ammonium base detergent / disinfectant
solution), carefully respecting the concentration and contact time prescribed by the manufacturer of the
solution.
Use a solution that bears the EC marking or that is in compliance with any standard required under the
applicable national regulations.
Rinse under running water for at least 30 seconds.
Mechanical / chemical cleaning
To be carried out immediately after pre- disinfection/chemical cleaning, wearing gloves.
Scrub the tip in a new bath containing the same enzymatic, quaternary ammonium base detergent /
disinfectant solution, using a metallic brush, for at least 30 seconds, and in any case until all remaining traces
of contamination have been removed.
Rinse again under running water for at least 30 seconds.
8 / 12 – User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D
c) Drying
Dry with a clean, non-woven single-use cloth, so as to remove any traces of liquid.
d) Sterilization conditions
Place in single-use sterilization pouches or bags in compliance with the specifications defined in standard EN
ISO 11607-1, or in any equivalent standard required by the national regulations.
It is essential to sterilize the handpiece, with the tip removed.
e) Sterilisation
The P
IEZOTOME
LED handpiece body and its three elements must be sterilized individually in an autoclave (Fig.
2-B) under the following conditions:
- Autoclave: Type B compliant with standard EN 13060.
- Sterilization temperature: 134°C.
- Sterilization stabilization time: 18 minutes.
- Pressure: 2 Bars min.
Remove the P
IEZOTOME
LED handpiece-cord assembly from the autoclave as soon as sterilization is complete.
Caution
:
• Always sterilize the P
IEZOTOME
LED handpiece-cord assembly without the insert.
• After multiple use, and during successive sterilizations, make sure before use that the P
IEZOTOME
LED
handpiece-cord assembly has not been damaged on the outside.
f) Assembly
- Connect the LED ring to the P
IEZOTOME
LED handpiece, making sure it is positioned correctly (align the "+" marks
on the LED ring and on the handpiece body near the LED ring electrical contacts) (Fig. 3)
- Insert t h e optical guide into the P
IEZOTOME
LED
handpiece nose.
- Screw on the front part (nose) of the handpiece.
g) Disposal and recycling
Disposal of the device and its accessories should be via a collection centre for electronic apparatus or by
returning them to Satelec After Sales Service. In no circumstances should the device and its accessories be
disposed of by the user. The use of the WEEE symbol indicates that this product must not be treated as
household waste, but must be treated separately, in conformity to the Directive
2002/96/CE. By ensuring this product is disposed of correctly, you will help to protect the environment. For
more detailed information about the recycling of this product, please contact your local authority, your house
waste disposal service provider or where you purchased the product. At the end of their life, tips should be
discarded in safety containers designed for this purpose
2. 2 REPLACEMENT
The P
IEZOTOME
LED handpiece must be replaced when the thread no longer holds the tips adequately and when
repeated sterilization cycles lead to visible damage of the casing (cracks, scratches).
The optical guide and the light ring of the P
IEZOTOME
LED handpiece must be replaced when the light intensity
is no longer sufficient and when repeated sterilization cycles lead to visible damage (cracks, scratches).
User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D - 9 / 12
2. 3 TROUBLESHOOTING
Refer to the table
F
AULT
P
OSSIBLE
C
AUSE
R
EMEDY
No spray
Incorrect irrigation line connection
Check the irrigation line connection
No water at tip but
vibration present
Obstructed tip
Remove obstruction
Incorrect spray adjustment
Adjust spray
Insufficient power -
Low vibration
Worn or deformed tip
Replace tip
No ultrasonic output
Incorrect tip tightening
Tighten with wrench
Defective connector contacts of the
P
IEZOTOME
LED handpiece-cord assembly
Clean cord connector and socket unit contacts
Cut wire in handpiece cord
Return to customer service for P
IEZOTOME
LED handpiece-
cord assembly replacement
No light
LED ring not fitted to the handpiece
Fit the LED ring
Faulty LED ring
Replace the LED ring
Faulty LED ring connector contacts
Clean the LED ring connector contacts
LED ring poles reversed
Position the LED ring according to the "+" foolproofing
marks.
Faulty handpiece and/or cord connector
contacts
Clean the handpiece and/or cord connector contacts
Other
Return to SATELEC after-sales
III - LIABILITY
The manufacturer's liability shall not be pledged in the following cases:
- Maintenance or repair by persons not authorized by the manufacturer.
- Use on an electrical installation that does not comply with the regulations in force.
- Other uses as those specified in this manual.
The manufacturer reserves the right to modify the handpiece and/or the user's manual without prior notice.
10 / 12 – User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D
MANUFACTURER IDENTIFICATION
SATELEC
A Company of ACTEON
Group
17, avenue Gustave Eiffel
BP 30216
33708 MERIGNAC cedex
France
Tel. +33 (0) 556.34.06.07
Fax. +33 (0) 556.34.92.92
E.mail :
satelec@acteongroup.com
www.acteongroup.com
BRANCH ADDRESSES
AUSTRALIA/NEW ZEALAND
ACTEON AUTRALIA/NEW ZEALAND
Suite 119, 30-40 Harcourt Parade
Rosebery NSW 2018
Australia
Tel. +612 9669 2292
Fax. +612 9669 2204
MIDDLE EAST
ACTEON MIDDLE EAST
247 Wasfi Al Tal str.
401 AMMAN - JORDAN
Tel. +962 6 553 4401
Fax. +962 6 553 7833
BRAZIL
MICRO IMAGEM INDUSTRIA COMERCIO
IMPORTAÇÃO E
EXPORTAÇÃO LTDA
CNPJ: 14.041.012/0001-79
Alameda Vênus, 233
Distrito Industrial
Indaiatuba – SP – CEP 13347-659
Brasil
Tel. +55 19 3936 809
RUSSIA
ACTEON RUSSIA
Moscow, Gilyarovskogo str, 6b1
+7 495 1501323
info.ru@acteongroup.com
CHINA
ACTEON CHINA
Office 401 - 12 Xinyuanxili Zhong Street -
Chaoyang District - BEIJING 100027 - CHINA
Tel. +86 10 646 570 11 / 2 / 3
Fax. +86 10 646 580 15
SPAIN
ACTEON MEDICO-DENTAL IBERICA, S.A.U.
Avda Principal n°11 H
Poligono Industrial Can Clapers
08181 SENTMENAT (BARCELONA) - SPAIN
Tel. +34 93 715 45 20
Fax. +34 93 715 32 29
GERMANY
ACTEON GERMANY GmbH
Industriestrasse 9 – 40822 METTMANN -
GERMANY
Tel. +49 21 04 95 65 10
Fax. +49 21 04 95 65 11
TAIWAN
ACTEON TAIWAN
11F., No.1, Songzhi Rd.
Xinyi Dist., Taipei City 11047
TAIWAN (R.O.C.)
+ 886 2 8729 2103
User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D - 11 / 12
Hong Kong Re. Office
21/F, On Hing Building
Central - Hong Kong
Tel. +852 66 962 134
THAILAND
ACTEON (THAILAND) LTD
23/45 Sorachai Building 16th floor - Sukumvit 63
Road, Klongton Nua - Wattana, BANGKOK 10110
- THAILAND
Tel. +66 2 714 3295
Fax. +66 2 714 3296
INDIA
ACTEON INDIA
1202, PLOT NO. D-9
GOPAL HEIGHTS, NETAJI SUBASH PLACE
PITAMPURA, DELHI - 110034 - INDIA
Tel. +91 11 47 018 291 / 47 058 291 / 45 618 291
Fax. +91 79 2328 7480
U.K.
ACTEON UK
Phoenix Park– Eaton Socon, St Neots
CAMBS PE19 8EP - UK
Tel. +44 1480 477 307
Fax. +44 1480 477 381
LATIN AMERICA
ACTEON LATINA AMERICA
Bogotà - COLOMBIA
Celular: +57 312 377 8209
U.S.A. & Canada
ACTEON North America
124 Gaither Drive, Suite 140
Mount Laurel, NJ 08054 - USA
Tel. +1 856 222 9988
Fax. +1 856 222 4726
User’s manual | Piezotome 2 Handpiece | J12821 | V4 |09 | 04/2018 | NO40EN050D
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