Satelec Acteon PIEZOTOME OLO User manual

User’s manual
Manuel d’utilisation
Manual de uso Benutzerhandbuch
Manuale d’uso
Handleiding voor de gebruiker
Manual de utilização
Användningshandbok
 

E NGLISH 4
F RANÇAIS 20
E SPAÑOL 36
D
EUTSCH 52
I
TALIANO 68
N EDERLANDS 84
P
ORTUGUÊS 100
S VENSKA 116

 132

4
ENGLISH
1 INTRODUCTION 5
2 WARNINGS 5-6
3 DESCRIPTION
Physical description 6-7
Technical characteristics 7-8
4 INSTALLATION / COMMISSIONING
Unpacking the device 8
Recommendations 8
Installation 8-9
First start-up 9
5 IRRIGATING SOLUTIONS 9
6 IRRIGATION LINES 9
7 SETTINGS / PARAMETERS / INTERFACE
Start-up 9
Parameters 9
Flush / prime 9
Irrigation 9
Ultrasound function 9-10
Tool kit 10
8 SAFETY 10-11
9 USING THE DEVICE 11
10 SWITCHING OFF THE DEVICE 11
CONTENTS
11 SERVING AND STERILIZATION
Servicing the device 12
Servicing the ultrasound handpiece 12
Servicing tips 12
Servicing irrigation lines 12
12 CHECKING / MAINTENANCE
Checking 12
Maintenance 12
Replacing fuses 13
Troubleshooting 14
13 ELECTROMAGNETIC COMPATIBILITY
Electromagnetic emissions 15
Electromagnetic immunity 16
Electromagnetic immunity /
radiofrequency mobile equipment 17
Recommended separation distances 18
Cable lengths 18
14 DISPOSAL AND RECYCLING 19
15 MANUFACTURER’S LIABILITY 19
16 REGULATIONS 16
17 SYMBOLS 148-149
18 CUSTOMER RELATIONS
Manufacturer identication 154
Subsidiaries 154-155
The list of accessories referred to in this manual is
not exhaustive. Consult your local dealer for further
information.

5
I - INTRODUCTION
Congratulations on the purchase of your new PIEZOTOME
SOLO™/PIEZOTOME SOLO LED device.
To maximise use of this cutting-edge product for
as long as possible, please read these instructions
carefully before switching on, using or servicing the
device.
Sentences containing the symbol are points of
particular importance.
Designed for clinical use:
Created by SATELEC, PIEZOTOME SOLO/PIEZOTOME SOLO LED is
a device designed to perform dental surgery including
osteotomies, osteoplasties, periodontal and implant
surgery...
II - WARNINGS
CAUTION:
United States Federal Law restricts the use of this
device solely to qualied, trained and competent
dental health practitioners or under their
supervision.
The surgical tips designed for PIEZOTOME SOLO/PIEZOTOME
SOLO LED are not compatible with the PIEZOTOME and
the IMPLANT CENTER, and vice versa.
PIEZOTOME SOLO/PIEZOTOME SOLO LED can only take tips
adapted to PIEZOTOME 2 or IMPLANT CENTER 2.
To reduce the risk of accidents, the precautions
stipulated below must be taken:
Device operators:
- Use of the device is restricted solely to graduate
dental health professionals, who are competent and
qualied within the usual context of their activities.
- If you have received this device by mistake, please
contact the device supplier to arrange for its return.
Interactions:
Interference may occur when used on
patients with cardiac pacemakers.
This system emits electromagnetic elds,
which means there are some potential risks. The
malfunctioning of implantable devices such as cardiac
pacemakers and ICDs (implantable cardioverter
debrillator) is possible:
- Ask patients and users if they have an implanted
device before using this product. Explain the
circumstances to them.
- Weigh the risks and benets and contact your
patient’s cardiologist or appropriate qualied
healthcare professional prior to performing the
treatment.
- Keep this product away from implanted devices.
- Make appropriate emergency provisions and take
immediate action if patients become ill.
- Symptom including a raised heartbeat, irregular
pulse, and dizziness may signal problems with a
cardiac pacemaker or ICD.
Electrical connection:
- Ask an approved dental installation technician to
connect your device to the electrical network.
- Warning: To prevent any risk of electric shock, this
device shall only be connected to a supply network
tted with a protective ground.
- The electrical network to which the device is
connected shall comply with the standards in force
in your country.
- If loss of electrical power during use is likely to
generate an unacceptable risk, the device must be
connected to a suitable power source (e.g. UPS).
- Do not attempt to connect to the device any other
accessories than those supplied by SATELEC.
Overheating, burns:
To avoid the risk of burns or of overheating:
- Please refer to the clinical booklet provided with
the device.
- The irrigation ow must be used all the time
during the clinical act (please refer to the clinical
booklet).
- Please replace the tips when the cutting part
becomes blunt or when the diamond coated part

6
becomes smooth and shiny.
- The handpiece must be cleaned properly and
regularly as mentioned in the user’s manual.
Using the device:
- Do not use the device if it appears to be damaged
or faulty.
- Before unplugging the mains power cable, switch
the device off.
- To unplug the mains power cable, pull the plug on
the end of the cable whilst holding the wall socket
with your other hand.
- Never use irrigating solution containers that are
not designed to be suspended from the bracket
provided.
- The device must only be used with bottles or pouches
of sterile water or physiological saline solution.
- The capacity of the irrigating solution container
used shall not exceed one litre.
- If you are not using or will be away from the device
for a period of time, disconnect the device from the
electrical supply network.
- Do not move the device during use.
- Do not apply excessive pressure to the screen.
Environment:
- Do not cover the device or obstruct the air inlets.
- Do not immerse and do not use outside.
- Do not tilt the device at an angle of more than 5°.
- Do not place the device near a heat source.
- Make sure that the cables do not prevent people
from moving about freely.
- The device shall be stored in its original packaging,
in a suitable place, which does not present a hazard
for people.
- The device is not designed to be used in a medical
operating room.
- The device is not designed to operate in the presence
of anaesthetic gases or any other ammable gas.
- Do not expose the device to water mist or spray.
- Any condensation inside an electrical device is
potentially dangerous. - If the device is to be moved
from a cold environment to a hot one, it must not be
used until it has reached room temperature.
- The device is not designed to operate in the vicinity
of ionizing radiation.
- Do not insert metal objects into the device to
prevent any risk of electric shock, short-circuit or
the emission of hazardous substances.
Servicing:
- Before and after each use, it is vital that you
disinfect your device using products recommended
by SATELEC.
- Prior to each intervention, it is imperative that you
use clean, disinfected and sterilized accessories.
Accessories:
- The device may only be tted with accessories
designed or recommended by SATELEC that are
perfectly suited to the purpose.
- Use of accessories from other manufacturers is a
potential hazard for you or your patients.
Repair:
- Warning: Do not repair or modify the device without
the prior authorization of SATELEC.
- Warning: If the device is modied or repaired,
specic inspections and checks shall be performed
to ensure that the device can still be used safely.
- In the event of an anomaly, contact the supplier of
your device. Do not contact any other repairer who
could render your device hazardous for you and your
patients.
In the event of doubt, contact an approved dealer or
the Customer service department:
- www.acteongroup.com
- E-mail: [email protected].
III - TECHNICAL DATA
3.1 PHYSICAL DESCRIPTION
The device comprises 5 main parts:
- A console (Fig. 1-1).
- A multifunction pedal (Fig. 4).
- A PIEZOTOME SOLO or PIEZOTOME SOLO LED handpiece and
cable (Fig. 1-2).
- A bracket for irrigating solution (Fig. 1-3).
- A mains power cable with ground (Fig. 1-4).

7
The top of the console incorporates:
- An LCD (Liquid Cristal Display) screen displaying dif-
ferent information (Fig. 1-5).
- A control keyboard enabling you to change the set-
tings of your device (Fig. 1-6).
The front face incorporates the handpiece cable
connector (Fig. 1-7).
The right side face incorporates the pump housing
(Fig. 1-8).
The back of the box incorporates the following ele-
ments:
- 1 mains connector with an earthing pin (Fig. 2-1).
- 1 pedal connector (Fig. 2-2).
- 1 fan (Fig. 2-3).
- 1 bracket support (Fig. 2-4).
- 1 mains isolating switch (Fig. 2-5).
- 1 potential equalizing terminal (Fig.2-6).
3.2 TECHNICAL DESCRIPTION
a) LCD screen / control keyboard
The device can be adjusted by applying moderate
pressure to the keyboard buttons.
Button positions (Fig. 3-1 to 5).
Item 1: Increase irrigation ow.
Item 2: Decrease irrigation ow.
Item 3: Flush/prime.
Item 4: Save, validate or select.
Item 5: Programme selection.
The LCD screen displays all information required by
the user.
Display positions (Fig. 3-6 to 9).
Item 6: Store in memory.
Item 7: Irrigation ow rate with associated bar graph.
Item 8: Programme with associated bar graph.
Item 9: Device status (ultrasound activated, error
detection).
b) Rear face of console
The mains connector (Fig. 2-1) with its earthing pin
allows the device to be connected to the electrical
network via a removable mains power cable.
The pedal connector (Fig. 2-2) allows the device to be
connected to the multifunction control pedal.
The fan (Fig. 2-3) protected by a metal grille ensures
the device always operates at optimum performance
level.
The bracket support (Fig. 2-4) allows the bracket to
be positioned.
The mains isolating switch (Fig. 2-5) is used to switch
the device on or off.
A potential equalizing terminal (Fig. 2-6) allows the
device to be connected to other installation equip-
ment as required.
c) Right-side face of console
The pump housing (Fig. 1-8) is designed to receive
SATELEC irrigation line cassettes.
An irrigation cassette is installed by lifting the pump
cover and inserting the cassette horizontally into the
purpose-designed housing.
d) Front face
The connector (Fig. 1-7) is designed to receive the
handpiece cable connector. Only the PIEZOTOME SOLO or
PIEZOTOME SOLO LED handpiece shall be used.
e) Control pedal
The control pedal allows professionals to work in a
completely sterile environment by preventing cross
contamination risks.
Once the various parameters have been set, the ope-
rator no longer needs to use the keyboard.
Pedal denition (Fig. 4-1 to 3).
Item 1: Ultrasound activation.
Item 2: Mode change (from d1 to d4).
Item 3: Arch.
f) Technical characteristics
Manufacturer: SATELEC
Name of device: PIEZOTOME SOLO or PIEZOTOME SOLO LED
Electrical supply:
- Voltage: 100 VAC to 230 VAC
- Frequency: 50 Hz / 60 Hz
- Nominal power: 150 VAC to 230 VAC
Operation:
Intermittent service: 10 mins ON / 5 mins OFF

8
Output characteristics:
No-load voltage: 250 Volts (nominal value without
handpiece)
Min. ultrasound frequency: 28 kHz
Irrigation ow rate: from 0 to 120 ml/min (nominal
value)
Adjustment in steps of 10 ml/min (nominal value)
Flush ow rate: 120 ml/min (nominal value)
Protection:
Electrical class: Class 1
Electrical safety class: BF
Safety:
Protection against internal malfunctions
2 fuses (mains connector): 5mm x 20mm / 2 AT for 100
VAC to 230 VAC
1 internal fuse that cannot be accessed by the ope-
rator reference F1: 5mm x 20mm – 10 AT / 250 VAC
Overall dimensions:
Console:
Width: 378mm
Height: 136mm
Height with bracket: 460mm
Depth: 306mm
Weight: 3700g
Pedal:
Depth: 176mm
Width: 173mm
Height with arch: 140mm
Weight: 1000g max
LCD screen:
Height: 86mm
Width: 115mm
Handpiece cable: 2000mm
Temperatures:
Operating: +10°C to +30°C
Storage: -20°C to +70°C
Humidity:
Operating: 30% to 75%
Storage: 10% to 100% including condensation
Atmospheric pressure:
Between 500 hPa and 1060 hPa
IV - INSTALLATION /
COMMISSIONING
4.1 UNPACKING THE DEVICE
Upon receipt of the device, look for any damage that
may have occurred during transportation.
If necessary, contact your supplier.
4.2 RECOMMENDATIONS
Ask an approved dental installation technician to
make any connection to the electrical network.
The device’s electrical connection shall comply with
standards in force in your country.
Warning: To avoid any risk of electric shock, this
device must be connected to an electrical power
supply with a protective ground.
4.3 INSTALLATION
Important:
Do not install PIEZOTOME SOLO/PIEZOTOME SOLO LED near to
or on another device.
Do not conceal the mains power cable and the pedal
cable in a cable cover or cable guide.
- Place the console on a xed horizontal surface or a
surface that is not sloped by an angle of more than
5 degrees.
- Check that the mains isolating switch (Fig. 2-5) is in
position O (stop).
- Connect the mains power cable to the device’s
mains connector (Fig. 2-1).
- Connect the mains power cable to the electrical
network socket equipped with an earthing pin.
- If necessary, connect the ground equipotential plug
of your installation to the potential equalizing ter-
minal of your device (Fig. 2-6).
- Connect the control pedal to the pedal connector
(Fig. 2-2).
- Position the pedal so that you can easily reach it
with your foot.
- Plug the bracket into the bracket support (Fig. 2-4).

9
- Connect the handpiece cable to the connector
(Fig. 1-7).
- Check that the device is sufciently close to the
working area to avoid having to stretch the cables.
If necessary, move the device closer.
- Hang the bottle or pouch containing physiological
saline solution from the bracket.
4.4 FIRST START-UP
Before using the device for the rst time, it is vital
that you service and/or sterilize all equipment in
accordance with the procedures dened in section 11.
V - IRRIGATING SOLUTIONS
The device is not designed to administer medical subs-
tances and shall only be used with bottles or pouches
containing no more than 1 litre of physiological saline
solution or sterile water.
VI - IRRIGATION LINES
The device shall be used with SATELEC irrigation lines.
VII - SETTINGS / PARAMETERS
/ INTERFACE
7.1 START-UP
Important:
It is recommended that you wait 4 seconds between
stopping and restarting the device.
At start-up, the device performs an auto-check
sequence and the screen displays programme d1
details.
7.2 PARAMETERS
The parameters are stored during the conguration
of each programme and are recalled each time you
select a programme.
7.3 FLUSH / PRIME
The ush/prime function is controlled using the
keyboard.
Press button (Fig. 3-3) to activate the ush/
prime function.
This function remains active while the button is
pressed down.
Flush can be activated during use of the device. The
ow rate during ush is 120ml/min.
7.4 IRRIGATION
a) Setting the irrigation ow rate
Set the irrigation ow rate by pressing the buttons
and (Fig. 3-1 and 2).
Each press adjusts the ow rate by + or – 10ml/min.
The value set is then displayed on the LCD screen (Fig.
3-7) in addition to a bar graph.
The ow rate is stored in the programme being used.
The ow rate can be altered during use of the device.
b) Deactivating irrigation
To deactivate irrigation, press the button (Fig.
3-2) until 0ml/min is displayed. The irrigation bar
graph (Fig. 3, item 7) is then blank.
7.5 ULTRASOUND FUNCTION
Important:
The irrigation parameters can be customised by the
user for each programme.
The ULTRASOUND function can be adjusted when
the handpiece is not connected to the device.
Programme d1 is the most powerful setting.
Select the programme to be used by pressing buttons
, , or (Fig. 3-5) or by pressing
the symbol on the pedal (Fig. 4-2)
The selected programme appears on the LCD screen
as d1, d2, d3 or d4 in addition to an associated bar
graph (Fig. 3-8)

10
Adjust the irrigation ow rate for each programme
according to the recommendations of the tip-related
instructions (see chap. 7.4)
Press the button to validate the new settings
(Fig. 3-4).
The storage of parameters is conrmed by an audible
and visual signal (logo changes colour).
Repeat this sequence to set all programmes, as
required.
7.6 TOOL KIT
Important:
The device has a TOOL KIT function used to make
various adjustments, such as brightness or return
to factory default settings.
To activate the TOOL KIT function, switch off the
device, wait for 4 seconds, switch the device back
on and press and (Fig. 3-1 and 2) as soon as
they appear on the home screen (Fig. 6).
A quick press on button (Fig. 3-4) allows you to
select the brightness settings menu (Fig.5-1) or
the default factory settings menu (Fig.5-2). The
selected menu is identied by a cross (Fig. 5-4).
a) Adjusting screen brightness
The user can adjust the brightness of the device
screen.
Select the brightness settings menu (Fig.5-1).
Adjust the brightness using the buttons and
(Fig. 3-1 and 2). The brightness can be adjusted
between 0% and 100%.
The brightness intensity level is indicated (Fig. 5-5).
b) Return to default factory settings
Returning to the default factory settings solely allows
irrigation ow rates to be restored.
Select the default factory settings menu
(Fig.5-2).
The various factory congurations will be effective
once you exit the tool kit.
The device is congured at the factory according to
the following parameters:
PROGRAMME
IRRIGATION
FLOW
RATES
MAINS
FUNCTIONS
Very
powerful D1 60ml/min Osteotomy, osteoplasty
Powerful D2 60ml/min
Average
power D3 60ml/min
Low power D4 60ml/min Soft tissue
removal
c) Timer
The device has a function that indicates the duration
of use of the device. The total duration is displayed
on screen (Fig. 5-7) under the logo (Fig.5-3).
The shortest duration displayed is one minute.
d) Software version
The software version is displayed at the bottom of the
screen (Fig. 5-6).
e) Storing settings
To store the modied parameters and use the device,
hold down button for a while (Fig. 3-4). The
screen shown in Fig. 6 reappears.
VIII - SAFETY
The device is tted with a system that can detect
malfunctions that may occur.
When an internal operating error occurs at start-up,
symbol 1 (Chap XVII - Symbols) lights up (Fig. 7-1) and
4 beeps sound.
When an internal operating error occurs during
operation, symbol 1 (Chap XVII - Symbols) lights up
(Fig. 8-1) and 4 beeps sound. We recommend that you

11
shut down the device with the mains isolating switch
(Fig. 2-5) then switch the device back on.
When the ultrasound function is activated and
the handpiece is not connected or is not properly
connected, symbol 2 (Chap XVII - Symbols) lights up
(Fig. 9-1) and 4 beeps sound. We recommend that you
connect the handpiece or check that it is correctly
connected to the device.
IX - USING THE DEVICE
Important:
- Do not disconnect the handpiece cable when the
device is on and the pedal is pressed down.
- Do not tighten or loosen the tips when the
handpiece is activated.
- All accessories used shall be previously cleaned,
disinfected and sterilized.
- For your safety and the safety of your patient,
the device shall only be used with accessories
supplied or recommended by SATELEC.
- Before and after each use, check the device and its
accessories to make sure there are no problems.
- If necessary, do not use the device and replace
any faulty parts.
Operate the device as follows:
- Make sure that the device is correctly plugged in and
corrected insulated.
- Set the mains isolating switch (Fig.2-5) to position
I (ON).
- Hang the bottle or pouch containing physiological
saline solution or sterile water from the bracket.
- Lift the lid of the irrigating pump.
- Horizontally insert an irrigation line cassette into
the purpose-designed housing.
- Lower the lid.
- Connect the irrigation line perforator to the bottle
or pouch containing physiological saline solution or
sterile water.
- Set the required parameters (irrigation ow rate,
programme), see chapter VII.
Note:
Automatic storage allows you to save the display
parameters used previously when switching between
the different programmes.
This sequence is carried under controlled aseptic
conditions for the safety of your patients. You may
require the help of an assistant.
- Connect the handpiece cable to the device connector
(Fig. 1-7).
- Screw the selected tip onto the handpiece using a
wrench (according to the recommendations of the
clinical manual).
- Attach the irrigation line to the cable using line
clips.
- Attach the end of the irrigation line to the handpiece.
- Prime the irrigation system by pressing the ush
button on the screen (Fig. 3-3)
- When the irrigation solution arrives at the tip of the
tip, release the pedal.
- Use the device in compliance with good dentistry
practice.
X - SWITCHING OFF THE
DEVICE
At the end of the dental procedure:
- Remove the bottle or pouch containing physiological
saline solution or sterile water from the bracket.
- Remove the irrigation line perforator from the bottle
or pouch.
- Immerse the irrigation line perforator in a container
of distilled water.
- Rinse the irrigation line and the handpiece by
activating the ush function until the receptacle
and the irrigation line are completely empty.
- Set the device to OFF (O).
- Disconnect the handpiece from the device.
- Remove the irrigation line clips.
- Disconnect the irrigation line from the handpiece
and throw it in a bin used for the disposal of used
medical items (irrigation line can only be used
once). See chapter 11.4.

12
XI - SERVICING AND
STERILIZATION
11.1 SERVICING THE DEVICE
Important:
The device must be OFF during cleaning/disinfection
procedures.
Do not use abrasive product, sprays or liquids to
clean and disinfect the console.
Avoid the use of cleaning and disinfection products
containing ammable agents.
If you do use such a product, make sure that all
the product has evaporated and that no ammable
agents remain on the device and its accessories
before using the device again.
The device, the bracket and the multifunction
pedal are not suitable for sterilization.
The console, the control pedal and the bracket shall
be cleaned and disinfected (using alcohol, disinfection
products, dentist disinfecting wipes, SEPTOL™ wipes)
systematically after each use.
The console must be checked regularly to detect any
problems.
It is important that you check the cleanliness of the
ventilation inlets on the console to prevent abnormal
heating.
11.2 SERVICING THE ULTRASOUND HANDPIECE
Important:
The handpiece is not delivered sterile.
Refer to the user’s manual delivered with the
equipment.
11.3 SERVICING TIPS
Important:
Tips are not delivered sterile.
Refer to the user’s manual delivered with the
equipment.
11.4 SERVICING IRRIGATION LINES
Sterile irrigation line
The disposable irrigation lines supplied by SATELEC
shall be systematically disposed off after each use.
The reuse of a disposable irrigation line may result
in contamination of your patients for which you are
liable.
Do not attempt to resterilize disposable irrigation
lines. Do not attempt to modify irrigation lines.
Sterilizable irrigation line
Refer to the instructions delivered with the
equipment.
To service, clean, decontaminate and sterilize the
sterilizable irrigation line, refer to the specic
technical maintenance guide.
XII-CHECKING/MAINTENANCE
Important:
In the event of an anomaly, we recommend you
contact the supplier of your device. Do not contact
any other repairer who may render your device
hazardous for you and your patients.
12.1 CHECKING
Check the device and its accessories regularly to
detect any insulation fault or any damage. Replace
if necessary.
It is important to check the cleanliness of the
ventilation grilles on the console ventilation to
prevent abnormal overheating.
12.2 MAINTENANCE
The device does not require any preventive
maintenance other than the checking of accessories
and frequent cleaning/disinfection.

13
12.3 REPLACING FUSES
Your device is protected by two fuses in the mains
connector (Fig. 2-1).
To replace these fuses, follow the steps below:
- Switch off the device (position O).
- Disconnect the mains power cable from the electrical
network.
- Disconnect the mains power cable from the mains
connector (Fig. 2-1).
- Insert the tip of a athead screwdriver into the
notch located above the fuse holder to release it.
- Remove the used fuses.
- Replace the used fuses with fuses of the same type
and the same amperage.
- Place the fuse holder in its recess by pushing it until
you hear a click conrming it is correctly installed.
- Connect the mains power cable to the mains (Fig.
2-1).
- Connect the mains power cable to the electrical
network.
Note:
The device also has an internal fuse not accessible
to the user. Contact SATELEC after-sales service (see
Chapter 2 - Repairs). All the information necessary for
the repair of faulty components is made available by
SATELEC to the technical personnel of the SATELEC-
approved dealer network who carry out the work.
12. 4 TROUBLESHOOTING
Refer to the table below:

14
Anomalies observed Possible causes Solutions
No operation (LCD screen
off)
Faulty connection of the mains power
cable
Check the mains plug.
Return to the SATELEC after-sales team.
Mains isolating switch in position O. Set the mains isolating switch to position I.
No mains voltage. Call out an electrician.
Fuse(s) in the mains connector not
working. Replace the fuses in the mains connector.
Internal fuse not working. Return to the SATELEC after-sales team.
No operation (LCD screen
on) Transmission fault. Switch off the device and switch it back it. Return to the SATELEC after-sales team.
No spray
Pouch or bottle of irrigating solution
empty.
Replace the pouch or bottle of irrigating
solution.
Irrigation deactivated. Increase the irrigation ow.
Irrigation line blocked. Replace the irrigation line.
Irrigation line pinched. Check the length of the irrigation line.
Unsuitable spray Irrigation ow rate wrongly set. Reset the irrigation ow rate.
Fault concerning the low
vibration power of tips
Tip worn or distorted. Replace the tip.
Incorrect power setting. Refer to the clinical guide for further
information.
Incorrect use: angle of approach
incorrect or inadequate pressure on
the clinical site.
Refer to the clinical guide for further
information.
Presence of liquid or humidity on the
handpiece connector. Thoroughly dry the electric contacts
No ultrasound
Tip not tight enough. Retighten the tip using the spanner.
Faulty connector contact. Clean the connector contacts.
Handpiece cable wire cut. Return to the SATELEC after-sales team to
replace the cable.
Liquid leak in the irriga-
tion pump
Pipe ruptured in the irrigation line
cassette. Replace the irrigation line.
No light
(Only on the PIEZOTOME SOLO
LED handpiece)
LED ring not tted 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 «+»
foolproong marks.
Faulty handpiece and/or cord connec-
tor contacts
Clean the handpiece and/or cord connector
contacts
Other Return to SATELEC after-sales

15
XIII - ELECTROMAGNETIC COMPATIBILITY
Important:
The power cord, the ultrasonic handpiece cords and the multifunction footswitch cord must be kept away
from each other.
The device requires special precautions to be taken with regard to electromagnetic compatibility.
It must be installed and prepared for use as described in chapter 4.
Certain types of mobile telecommunication devices such as mobile telephones are likely to interfere with the
device.
The recommended separation distances in this paragraph must therefore be complied with.
The device must not be used near or on top of another device.
If this cannot be avoided, its operation under the conditions of use must be checked beforehand.
The use of accessories other than those specied or sold by SATELEC as replacement parts may have the
consequence of increasing the emissions or decreasing the immunity of the device.
13. 1 ELECTROMAGNETIC EMISSIONS
The device is intended for use in the electromagnetic environment specied in the table below. The user and/
or installer must ensure that the device is used in such an environment.
Emission test Compliance Electromagnetic environment - guidance
RF emission - CISPR 11. Group 1
The device uses RF energy for internal operation.
Therefore, its radiofrequency emissions are very low and are not likely
to cause any interference in nearby equipment.
RF emission - CISPR 11. Class B
The device is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage
power supply network that supplies buildings used for domestic
purposes.
Harmonic current emission
IEC 61000-3-2. Class A
Voltage uctuation and
icker
IEC 61000-3-3.
Complies

16
13. 2 ELECTROMAGNETIC IMMUNITY
The device is intended for use in the electromagnetic environment specied in the table below. The user and/
or installer must ensure that the device is used in such an electromagnetic environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2.
± 6 KV contact
± 8 KV air
± 6 KV contact
± 8 KV air
Floors must be wood, concrete, cement or tiled.
If oors are covered with synthetic material
(carpet, etc.), the relative humidity must be at
least 30%.
Electrical fast
transients
IEC 61000-4-4.
± 2KV for power
supply lines
± 2KV for power
supply lines
Mains power quality should be that of a typical
commercial or hospital environment (hospital,
clinic).
Surges
IEC 61000-4-5.
± 1KV differential
mode
± 2KV common mode
± 1KV differential
mode
± 2KV common mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage
dips, short
interruptions
and voltage
variations
IEC 61000-4-11.
<5% UT(>95% dip in
UT) for 0.5 cycles.
40% UT(60% dip in UT)
for 5 cycles
70% UT(30% dip in UT)
for 25 cycles
<5% UT(>95% dip in
UT) for 250 cycles
<5% UT(>95% dip in
UT) for 0.5 cycles.
40% UT(60% dip in UT)
for 5 cycles
70% UT(30% dip in UT)
for 25 cycles
<5% UT(>95% dip in
UT) for 250 cycles
Mains power quality should be that of a typical
commercial or hospital environment.
If the use of the device requires continued
operation during power mains interruption, it is
recommended that the product be powered from a
separate power supply (UPS, etc.).

17
13. 3 ELECTROMAGNETIC IMMUNITY / RADIOFREQUENCY MOBILE EQUIPMENT
The device is intended for use in the electromagnetic environment specied in the table below. The user and/
or installer must ensure that the device is used in such an electromagnetic environment.
Immunity test IEC 60601 test
level Compliance level Electromagnetic environment - guidance
Portable and mobile radiofrequency communications devices must not be used near the device (including its cables) at
a distance less than that recommended and calculated according to the frequency and power of the emitter.
Conducted
disturbance,
radiofrequency elds.
IEC61000-4-6
3 V/m
150 KHz to 80
MHz
3 V/m
Recommended separation distance:
d = 1.2
Radiated
radiofrequency
electromagnetic eld.
IEC61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m
d = 1.2 80MHz to 800MHz.
d = 2.3 800MHz to 2.5GHz.
Where P is the maximum power rating of the emitter
in watts (W) according to the manufacturer’s
specications and d is the recommended minimum
separation distance in meters (m).
The electromagnetic eld strengths of xed radiofrequency emitters, as determined by an electromagnetic
environment measurement (a), must be less than the compliance level in each frequency range (b).
Interference may occur near equipment marked with the symbol below:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These specications may not be applicable in all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects and persons.
(a): The electromagnetic eld strengths of xed radiofrequency emitters, such as base stations for mobile
telephones (cellular/cordless), mobile radios, amateur radio, AM/FM radio broadcasts and TV broadcasts
cannot be determined exactly by theory. To assess the electromagnetic environment due to xed
radiofrequency emitters, an electromagnetic environment measurement must be made. If the measured
radiofrequency eld strength in the immediate environment where the product is used exceeds the
compliance level specied above, the performance of the product must be tested to verify whether it
conforms to the specication. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the product.
(b): In the 150 kHz to 80 MHz frequency range, the electromagnetic eld strengths must be less than 3 V/m.

18
13. 4 RECOMMENDED SEPARATION DISTANCES
The device is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances
are controlled.
The device user and/or installer can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile radiofrequency communications equipment emitters and the device,
according to the maximum output power of the equipment, as recommended in the table below.
Rated max. power of the
emitter (W)
Separation distance in metres (m) according to emitter frequency
150 KHz to 80 MHz
d = 1.2
80 MHz to 800 MHz
d = 1.2
800 MHz to 2,5 GHz
d = 2.3
0.01 0.12 m 0.12 m 0.23 m
0.1 0.38 m 0.38 m 0.73 m
1 1.2 m 1.2 m 2.3 m
10 3.8 m 3.8 m 7.3 m
100 12 m 12 m 23 m
For emitters rated at max. power not listed above, the recommended separation distance d in meteres (m) can be
estimated using the equation applicable to the frequency of the emitter, where P is the max. power rating of the
emitter in watts (W) according the manufacturer.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These specications may not be applicable in all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects and persons.
13. 5 CABLE LENGTHS
Cables and
accessories
Maximum
length Complies with:
Handpiece
cords
Footswitch
cord
Power supply
cord
Less than
3m
RF emission, CISPR 1 - Class A/Group 1
Harmonic current emission: IEC61000-3-2
Voltage uctuation: IEC61000-3-3
Immunity to electrostatic discharge: IEC61000-4-2
Immunity to electrical fast transients/bursts: IEC61000-4-4
Immunity to surges: IEC61000-4-5
Immunity to voltage dips, short interruptions and voltage variations: IEC61000-4-11
Immunity to conducted disturbances induced by radiofrequency elds: IEC61000-4-6
Immunity to radiated radiofrequency electromagnetic elds: IEC61000-4-3

19
XIV - DISPOSALAND RECYCLING
As electrical and electronic equipment, the device
must be disposed of according to a specialized
procedure for collection, pick-up and recycling
or destruction (in particular on the European
market, with reference to Directive 2002/96/EC of
27/01/2003).
When your device reaches the end of its life, we
consequently recommend that you contact your dental
equipment dealer (or, failing this, the ACTEON Group
website, the address of which is given in chapter 18),
for information on how to proceed.
XV - MANUFACTURER’S
LIABILITY
The manufacturer is not liable if:
- the manufacturer’s installation recommendations
have not been followed (supply voltage,
electromagnetic environment, etc.)
- repairs or other work have been done on the device
by persons not authorized by the manufacturer
- the device has been used connected to an electrical
system that does not comply with current regulations
- the device has been used in ways other than those
specied in this manual
- accessories (tips, handpiece, irrigation lines, etc.)
other than those supplied by SATELEC have been
used
- the instructions in this document have not been
followed.
Note: The manufacturer reserves the right to modify
the device and/or the user’s manual without notice.
XVI - REGULATIONS
This medical device is classied as class IIa according
to European Directive relevant to Medical Devices
currently in force.
This equipment is manufactured in compliance with
the current IEC 60601-1 standard.
This equipment has been designed and manufactured
according to an ISO 13485-certied quality assurance
system.

20
FRANÇAIS
1 INTRODUCTION 21
2 AVERTISSEMENTS 21-22
3 DESCRIPTION
Description physique 23
Description technique 23-24
4 INSTALLATION / MISE EN SERVICE
Déballage de l’appareil 24
Recommandations 24-25
Installation 25
Première mise en service 25
5 SOLUTIONS D’IRRIGATION 25
6 LIGNES D’IRRIGATION 25
7 REGLAGES / PARAMETRES / INTERFACE
Démarrage 25
Paramètres 25
Purge / amorçage 25-26
Irrigation 26
Fonction ultrasons 26
Boîte à outils 26-27
8 SECURITES 27
9 UTILISATION DE L’APPAREIL 27-28
10 ARRET DE L’APPAREIL 28
SOMMAIRE
11 ENTRETIEN ET STERILISATION
Entretien de l’appareil 28
Entretien de la pièce à main ultrasons 28
Entretien des inserts 29
Entretien des lignes d’irrigation 29
12 SURVEILLANCE / MAINTENANCE
Surveillance 29
Maintenance 29
Remplacement des fusibles 29
Anomalies de fonctionnement 30
13 COMPATIBILITE ELECTROMAGNETIQUE
Emissions électromagnétiques 31
Immunité électromagnétique 32
Immunité électromagnétique/équipements
portables radiofréquences 33
Distances de séparation recommandées 34
Longueur des câbles 34
14 ELIMINATION ET RECYCLAGE 35
15 RESPONSABILITE DU FABRICANT 35
16 REGLEMENTATION 35
17 SYMBOLES 148-149
18 RELATIONS CLIENTELES
Identication du fabricant 154
Adresse liales 154-155
La liste des accessoires mentionnés dans cette notice
est non exhaustive. Consulter votre revendeur pour
plus d’informations.