Acteon ImplantCenter M+ User manual

User Manual
ImplantCenter M+

Contents
1 Documentation 7
1.1 Associated documentation 7
1.2 Electronic documentation 7
2 Required information 9
2.1 Indication for use 9
2.2 Operating principle 9
2.3 Date of first inclusion of EC marking 9
2.4 Latest document update 9
2.5 Repairing or modifying the medical device 9
2.6 Warranty 10
2.7 Accessory usage conditions 10
3 Removal from packaging, installation, connections 11
3.1 Removing the medical device from its packaging 11
3.2 Installing the medical device 11
3.3 Installing cords 11
3.4 Connecting the medical device to the electrical network 11
3.5 Fixing the medical device to a non-removable support 12
4 Medical device description 13
4.1 Control unit 13
4.2 I-Surge LED micromotor and handpieces 13
4.3 Cords 13
4.4 Inlets 13
4.5 Switch 13
4.6 Mains connector 13
4.7 Fuse recess 13
4.8 Pump 13
5 User interface 14
5.1 I-surge mode 14
5.2 Piezotome® M+ mode 15
5.3 Newtron® mode 16
6 Medical device use 17
6.1 Preparing the medical device 17
6.1.1 Connecting the medical device to the electrical network 17
6.1.2 Footswitch 17
6.1.3 Installing the footswitch 17
6.1.4 Connecting the I-Surge LED micromotor 17
6.1.5 Connecting the Piezotome® M+ handpiece 17
6.1.6 Connecting the Newtron® handpiece 17
6.1.7 Installing the irrigation system 17
6.1.8 Purging the medical device 18

6.2 Switching on the medical device 18
6.3 Selecting the operating mode 18
6.3.1 Common operations using the footswitch 18
6.4 Connecting and disconnecting M+ accessories during use 19
6.5 Switching off the medical device 19
7 Configuring the medical device 21
7.1 Adjusting the medical device volume 21
7.2 Adjusting the screen brightness 21
7.3 Adjusting the lighting timer 21
7.4 Recovering the medical device's factory settings 21
7.4.1 I-Surge mode factory settings 22
7.4.2 Piezotome mode factory settings 22
7.4.3 Newtron mode factory settings 22
7.5 Personalising a contra-angle or handpiece 22
8 Cleaning, disinfecting and sterilising 23
8.1 Cleaning and disinfecting the medical device 23
8.2 Cleaning, disinfecting and sterilising accessories 23
9 Monitoring and general maintenance of the medical device 25
10 Maintenance 27
10.1 Touch-sensitive screen messages 27
10.1.1 Problem at start up 27
10.1.2 Missing handpiece 27
10.1.3 I-Surge LED micromotor missing 27
10.1.4 Finding the software version 28
10.2 Identifying incorrect operation 28
10.2.1 Not working 28
10.2.2 The power is not as expected 28
10.2.3 No spray or very little amount of spray 29
10.2.4 Light not working or too dim 29
10.2.5 Water leakage 29
10.2.6 Ultrasounds not working 29
10.3 Corrective maintenance 30
10.3.1 Replacing the fuses 30
11 Technical specifications of the medical device 31
11.1 Identification 31
11.2 Control unit 31
11.3 Generator 31
11.4 Screen 31
11.5 Length of cords 31
11.6 I-Surge LED micromotor 32
11.7 Irrigation 32
11.8 Footswitch 32
11.9 Environmental characteristics 32
11.10 Environmental restrictions 32
11.11 Main performance characteristics 32
12 Regulations and standards 33
12.1 Official texts 33
12.2 Medical class of the device 33
12.3 Standardised symbols 33
12.4 Manufacturer identification 34
12.5 Branch addresses 35
13 Disposal and recycling 37
14 Index 39

15 Glossary 41

Foreword
The SATELEC®medical device that you are about use is designed for professional use only. It
is therefore a key tool with which you will provide treatment within the context of your
work.
These medical devices are designed to be used exclusively within a hospital or private clinic
operating theatre. Patients will be under general anaesthesia unless the procedure only
requires local anaesthesia.
To ensure optimum safety for yourself and your patients, comfort in your daily practice and
to benefit fully from your medical device's technology, please read the documentation
provided carefully.
If you have received this medical device by mistake, please contact the supplier to arrange
for it to be collected.
Please refer to the instructions for the entire range of SATELEC®M+ ultrasonic medical
generators for information about the following:
ldocumentation format;
ldocumentation archiving period;
lwarnings concerning user and patient populations;
ltreatment area;
lmedical device usage interactions, contraindications and prohibitions;
lelectromagnetic compatibility;
ldisposal and recycling of the medical device;
lmanufacturer responsibility.
Please refer to the various cleaning, disinfection and sterilisation protocols for information
about the following:
lpreparation of parts for sterilisation;
ldetailed manual and automatic protocols;
linformation concerning conditioning for sterilisation;
lrecommendations for the inspection of parts.

1 Documentation
This document contains the following information:
lindications for use
lmedical device description
linstallation of the medical device
lmedical device use
lpreparation prior to cleaning and disinfecting the medical device
lmonitoring and general maintenance of the medical device
lmaintenance to be performed by the user.
1.1 Associated documentation
This document must be used in association with the following documents:
Document title References
General instructions relating to the complete range of M+ medical ultrasonic generators J57821
General instructions relating to all M+ medical handpieces J12861
Method for consulting electronic user instructions J00000
Cleaning, disinfection and sterilisation protocols for SATELEC®tips J02001
Cleaning, disinfection and sterilisation protocols for the Piezotome®M+handpiece J12801
Cleaning, disinfection and sterilisation protocols for the maintenance-free I-Surge LED
implantology motor J28721
I-Surge LED micromotor Quick Clean J27120
User manual for I-Surge LED micromotor I27210
ImplantCenter™M+ Quick Start J27260
ImplantCenter™M+ Quick Clean J27261
ImplantCenter™M+ user manual J27251
Piezotome®M+ handpiece user manual J57521
Newtron®handpiece user manual I12610
Newtron®handpiece Quick Clean J12930
Pack M+ Quick Start J57870
Pack M+ Quick Clean J57871
Pack M+ user manual J57841
User manual for sterile M+ bone surgery tips J87601
User manual for non sterile M+ bone surgery tips J87611
M+ bone surgery tips Quick Reference J87621
User manual for the sterile CMF kit J57831
User manual for the non-sterile CMF kit J57881
1.2 Electronic documentation
The user instructions for your device are provided in electronic format and not in printed format. However, you
can request a free printed copy of the user instructions within 7 days via our website, by telephone or in
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writing.
The electronic user instructions are available in PDF format (Portable Document Format) and you will need to
have a PDF file read software installed to read the instructions.
The device user instructions can be consulted at the following address:
www.satelec.com/documents
It is important for you to have read and understood the content of the user instructions relating to the use of
your device and its accessories prior to use.
We recommend that you visit the website regularly to consult and/or to download the latest version of your
device's user instructions.
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2 Required information
2.1 Indication for use
ImplantCenter™M+ is a surgical device that combines an M+ surgical or ultrasonic piezoelectric handpiece and
a rotary surgical motor.
The Piezotome®M+ piezo-ultrasonic surgical handpiece can be used in combination with M+ tips for cutting
into bone, metal and bone substitutes.
The device's Piezotome®M+ surgical piezoelectric part can be used for osteotomy, osteoplasty, decortication,
drilling, shaping and smoothing of teeth and bone in various surgical procedures, including but not limited to
general, orthopaedic, otolaryngological, maxillofacial, oral, hand and foot, neurosurgery, spinal and
plastic/reconstructive surgery.
The Newtron®piezo-ultrasonic handpiece associated with dental tips can be used for mechanised ultrasonic
dental treatments, e.g. by periodontics, endodontics, scaling and prosthetics practices.
The rotary surgical I-Surge LED motor is indicated for use in dentistry such as implantology, dental surgery and
endodontics as well as maxillofacial surgery.
The device can be used on patients of all ages, including paediatric patients.
2.2 Operating principle
An electrical signal emitted by the medical device is supplied to the dental piezo-ultrasonic handpiece. It
comprises a piezoelectric ceramic transducer, which converts the electrical signal into ultrasonic vibrations.
Mechanical vibrations are transmitted to a tip attached to the end of the ultrasonic handpiece.
The vibrations, applied with a very gentle pressure, cut the bone with ultrasounds. They act distinctively on
the bone, minimising the risks of damaging the soft tissue, thereby guaranteeing a more precise and safe
procedure with less strain on the surgeon's hand. This ultrasonic piezoelectric surgical procedure also improves
bone healing.
The I-Surge LED rotary surgical micromotor can be used in combination with a handpiece, a rotary contra-angle
and other rotary drills or oscillating saws. It can be used for cutting into bone, placing screws, broaches and
retaining wires.
The type of coupling of the I-SURGE LED micromotor developed by SATELEC® is compatible with most contra-
angles and straight handpieces.
Contra-angles and straight handpieces are not supplied by SATELEC®
2.3 Date of first inclusion of EC marking
2013
2.4 Latest document update
09/2013
2.5 Repairing or modifying the medical device
Contact the supplier of your device. Using the services of an unapproved repairer could render your device
dangerous for you and your patients.
Do not repair or modify the device without seeking the prior permission of SATELEC®.
If the device is modified or repaired, specific checks and tests must be carried out to ensure that the medical
device is still safe to use.
In the event of doubt, contact an approved dealer or the SATELEC®customer service team:
www.acteongroup.com
[email protected]
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SATELEC®at the request of technical personnel working for the network of dealers approved by
SATELEC®, provide all information required to repair the faulty parts on which they may perform
repairs.
2.6 Warranty
The user may not remove any of the screws shown on this view, as this would invalidate the medical device's
warranty.
2.7 Accessory usage conditions
Accessories, handpieces and motors must be cleaned, disinfected and sterilised prior to use.
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3 Removal from packaging,
installation, connections
3.1 Removing the medical device from its packaging
When you receive your medical device, check for any damage that may have occurred during transportation.
If you have received this medical device by mistake, please contact the supplier to arrange for it to be
collected.
If you have any questions or requirements, contact your supplier.
The ImplantCenter™M+ includes the following items:
lan ImplantCenter™M+ unit
lan I-Surge LED implantology motor and cord
la multifunction footswitch
ltwo peristaltic pump recesses
ltwo Irrigation solution brackets
lfive irrigation lines with 10 single-use sterile clips
ltwo handpiece supports
l30 single-use, sterile irrigation line perforators
la power cord
la [J27260] Quick Start guide,a [J27261] Quick Clean guide
lan attachment kit.
3.2 Installing the medical device
Place the control unit in the position that is suitable for your activity. Check that the cords do not hinder the
movement or free circulation of anyone. The medical device must be placed on a secure and flat surface or a
surface with a maximum slope of 5 degrees.
Fix your medical device using the attachments provided to ensure that the device cannot be removed without
the use of a tool.
Adjust the position of your medical device to correspond to your angle of vision and the characteristics of your
workstation, e.g. lighting or distance between the user and the medical device.
Ensure that your medical device is readily accessible.
Do not install your medical device near or on another device.
3.3 Installing cords
Check that the cords do not hinder the movement or free circulation of anyone. Make sure that it is not possible
to wheel over or walk on the different cords. Cords attached to their handpiece or I-Surge LED micromotor
must be readily accessible. Make sure that the cord is slack during use.
Never rotate the handpiece connector on its cord as this can damage your medical device.
Never wrap the handpiece cord around the medical device. Do not put the medical device cords in a
cable cover or a cable tray.
3.4 Connecting the medical device to the electrical network
Switch the medical device OFF (position O) and check that the mains voltage is compatible with that indicated
on the medical device. Next, connect the cord to the wall socket in compliance with the standards in force in
the country of use.
The medical device is equipped with a protective ground connection and must be connected to a mains power
supply with a protective ground.
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Do not plug the medical device into an extension lead and do not put the mains cord in a cable cover or
cable tray.
A different voltage would cause damage to the medical device and could injure the patient and/or user. Any
variation in the electrical network voltage or electromagnetic field that is non-compliant with the limits in
force, could interfere with the medical device's operation.
If when using the medical device, a power outage can create an unacceptable risk, the user and the
installer must ensure that the medical device is connected to an appropriate power source such as an
uninterruptable power supply.
3.5 Fixing the medical device to a non-removable support
Your medical device is not designed to be moved. To avoid accidentally dropping the device, we recommend
that you find a suitable place to install it in your practice and attach it with the kit [F57811] supplied with it,
to ensure that it cannot be dismantled or moved without using a tool.
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4 Medical device description
4.1 Control unit
The control unit is compatible with:
1. The I-surge LED rotary technology via an I-surge LED surgical micromotor.
2. Newtron®ultrasonic piezoelectric technology via the surgical Piezotome® M+ handpiece or via the
Newtron® dental handpiece and cord.
The piezo-ultrasonic technology common to both piezoelectric handpieces, called Newtron®, is a patented
system that automatically controls the frequency and power of tips in real time: the Cruise Control® system.
Ultrasonic tips therefore maintain an even efficiency on the work area, regardless of the environment.
Ultrasonic tips are active on hard tissue only, with minimal risks for soft tissues.
The micromotor can be used in combination with either the Piezotome®M+ handpiece, or with the Newtron®
handpiece.
The touch-sensitive interface calls up all programmes stored in the memory and adjusts them before and after
use.
4.2 I-Surge LED micromotor and handpieces
Only SATELEC®handpieces and I-Surge LED micromotor can be connected to the medical device. For further
information, refer to the documentation listed in chapter chapter Associated documentation page 7.
4.3 Cords
The micromotor cord is only compatible with the I-Surge LED micromotor.
The Newtron®handpiece cord is only compatible with the Newtron®handpiece. It ensures irrigation
circulation and is used to connect the medical device to the Newtron®handpiece.
The Piezotome®M+ cord is only compatible with the Piezotome®M+ handpiece. It ensures circulation and is
used to connect the medical device to the Piezotome®M+ handpiece.
4.4 Inlets
The inlets at the back of the medical device provide suitable ventilation of the control unit and must be kept
clear.
4.5 Switch
The mains switch is used to switch the medical device on (position I) or off (position O).
4.6 Mains connector
The mains connector with its earthing pin is used to connect the device to the electrical network via a
disconnectable mains cord.
4.7 Fuse recess
The mains cord connector holds the recess for two mains fuses designed to protect the medical device in the
event of overvoltage or an internal fault.
4.8 Pump
The medical device is fitted with two peristaltic pumps. A single-use pump is connected to the irrigation line.
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5 User interface
Pictograms
shared by the three
modes
Meaning
Start/stop purge
Displays the flow in ml/min
Irrigation ON
Irrigation OFF
Adjusts the irrigation flow rate.
Handpiece lighting on
Handpiece lighting off
Progressive footswitch
Smooth footswitch
Warning. The type of warning is specified by a pictogram at the centre of the triangle.
Saves any changes
5.1 I-surge mode
Before using the I-Surge mode, read the setting recommendations specified by the contra-angle or
handpiece manufacturer
Pictograms
for the I-Surge
mode
Meaning
Current contra-angle - press the pictogram to select a different contra-angle or personalise a
specific contra-angle
Revolutions per minute- adjust this value using the + and - pictograms on the screen
Newton per centimetre - press the pictogram to adjust the torque of the force applied at the
outlet of the contra-angle
In P1, P2 and P3, adjust the number of revolutions per minute directly. In P4, adjust the torque in
real time.
Select programme P1 - Marking of the implant site
Select programme P2 - Pilot drilling
Select programme P3 - Boring/drilling
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Pictograms
for the I-Surge
mode
Meaning
Select programme P4 - Screwing
Clockwise rotation
Anti-clockwise rotation
I-Surge mode programme settings
Programme Contra-angle
ratio
Speed
at end of tool
Torque
at end of tool Irrigation Function
P1 20:1 1200 rpm 80 N.cm 80 ml/min Implant site marking
P2 20:1 800 rpm 80 N.cm 100 ml/min Pilot drilling
P3 20:1 15 rpm 20 N.cm 100 ml/min Boring/drilling
P4 20:1 30 rpm 20 N.cm 0 Screwing
5.2 Piezotome®M+ mode
Before using an M+ tip, read the M+ tip user manuals [J87601] and [J87611] and the Quick Reference
guide for M+ tips [J87621].
Pictograms
for the Piezotome
mode
Meaning Power
Select programme D1 - Osteotomy, osteoplasty Very powerful
Select programme D2 - Osteotomy, osteoplasty Powerful
Select programme D3 - Osteotomy, osteoplasty Average power
Select programme D4 - Separation of soft tissue Low power
Used power per programme - press the + and - pictograms to adjust the value
Adjust the power
Programme Power Irrigation
D1 3 60 ml/min
D2 3 60 ml/min
D3 3 60 ml/min
D4 3 60 ml/min
Fine setting adjusts the power level for each programme between 1 and 5. The power value is a percentage of
the maximum power at D1-5.
Programme D1
Fine setting level 1 2 3 4 5
Power value 82% 86% 90% 95% 100%
Frequency modulation 60 Hz
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Programme D2
Fine setting level 1 2 3 4 5
Power value 64% 68% 72% 74% 78%
Frequency modulation 60 Hz
Programme D3
Fine setting level 1 2 3 4 5
Power value 44% 48% 52% 56% 60%
Frequency modulation 60 Hz
Programme D4
Fine setting level 1 2 3 4 5
Power value 41% 46% 51% 56% 60%
Frequency modulation 30 Hz
5.3 Newtron®mode
Pictograms
for the Newtron mode Meaning Power
Soft Mode Low
Medium Mode Medium
High Mode High
Boost Mode Very high
Used power - use the + and - pictograms to adjust the value
Adjust the power
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6 Medical device use
6.1 Preparing the medical device
6.1.1 Connecting the medical device to the electrical network
lSet the ON/OFF switch to O position (off).
lConnect the power cord to the device's mains connector.
lConnect the mains power cord to the mains socket equipped with an earthing pin.
lIf necessary, connect the potential equalisation cable to the medical device's potential equalisation
terminal marked with .
6.1.2 Footswitch
The practitioner can start up the medical device using the footswitch. Press the footswitch to automatically
start the ultrasounds on Piezotome®M+ and Newtron®handpieces. The footswitch also controls the I-Surge LED
micromotor.
The footswitch equipped with its cord cannot be disconnected. Its weight and antislip pad ensure good stability.
The light function remains active for approx. 9 seconds after the footswitch is released.
6.1.3 Installing the footswitch
The footswitch must be positioned near the operator's feet and must always be within reach.
6.1.4 Connecting the I-Surge LED micromotor
Check for any traces of humidity on the I-Surge LED cord connector. Wipe them off if there are any.
Connect the cord connector to the socket, by aligning the red indexing points and by avoiding rotation
movement. Place the I-Surge LED micromotor on the support.
6.1.5 Connecting the Piezotome®M+ handpiece
Check for any traces of humidity on the handpiece cord connector. Wipe them off if there are any.
Connect the cord connector to the socket, by aligning the red indexing points and by avoiding rotation
movement. Place the handpiece on the support.
6.1.6 Connecting the Newtron®handpiece
Check for any traces of humidity on the handpiece cord connector. Wipe them off if there are any.
Connect the cord connector to the socket, by aligning the red indexing points and by avoiding rotation
movement. Place the handpiece on the support.
6.1.7 Installing the irrigation system
Equipment: one sterile M+ irrigation line, 10 single-use sterile clips, one sterile perforator with cap, one
bracket, one solution bag.
1. Insert the bracket into its holder
2. Open an irrigation line with its cassette
3. Slide the cassette into its support on the side of the medical device
4. Install the clips on the handpiece cord
5. Attach the irrigation line
6. Connect the end of the irrigation line to the water inlet on the handpiece
7. Install a bag on the bracket
8. Remove the cap from the perforator and insert the perforator into the solution bag.
The medical device must always be used with SATELEC®M+ irrigation lines.
The medical device is not designed to administer medication and must only be used with bottles or bags
containing no more than 1 litre of physiological saline solution or sterile water.
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6.1.8 Purging the medical device
The medical device must be purged before and after use.
1. Immerse the irrigation line perforator in a container with distilled water.
2. Press to rinse the irrigation line and the I-Surge LED micromotor or handpiece.
3. Minimum purge time is 1 minute.
6.2 Switching on the medical device
Place the I/O switch to I. The ImplantCenter™M+ indicates that the device is switched on by an audible signal.
The ImplantCenter™M+ detects which handpiece cord is connected (Piezotome®or Newtron®) and the
relevant menu will be displayed on the screen.
6.3 Selecting the operating mode
The ImplantCenter™M+ can be used in any of the following modes:
lI-Surge: with I-Surge LED micromotor and contra-angles or a straight handpiece
lPiezotome: with Piezotome®M+handpiece;
lNewtron: with Newtron®handpiece.
Switch between modes by pressing the pictograms or using the footswitch as follows.
6.3.1 Common operations using the footswitch
The footswitch is used for common operations.
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