Instrumentarium Dental PaloDEx Group SM Digital Intraoral Sensor User Manual

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Document ID	825850
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Document Type	User Manual
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Date Submitted	2007-08-06 00:00:00
Date Available	2007-08-06 00:00:00
Creation Date	2007-04-26 14:38:27
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Sigma M
User Manual
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Copyright
Code: 200150 rev 3
Date: 26 April 2007
Document code: D500616 rev 3
Copyright © 04/2007 by PaloDEx Group Oy. All rights
reserved.
Documentation, trademark and the software are copyrighted with all
rights reserved. Under the copyright laws the documentation may not
be copied, photocopied, reproduced, translated, or reduced to any
electronic medium or machine readable form in whole or part, without
the prior written permission of Instrumentarium Dental.
The original language of this manual is English.
Instrumentarium Dental reserves the right to make changes in
specification and features shown herein, or discontinue the product
described at any time without notice or obligation. Contact your
Instrumentarium Dental representative for the most current
information.
Manufactured by
Instrumentarium Dental
Nahkelantie 160 (P.O. Box 20)
FI-04300 Tuusula
FINLAND
Tel. +358 45 7882 2000
Fax. +358 45 7882 2506
For service, contact your local distributor.
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Table of Contents
Sigma M system ....................................................................................... 1
1.1
1.2
1.3
1.4
Capturing intraoral images ..................................................................... 9
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
Introduction ........................................................................................................... 1
Main parts of the Sigma M device......................................................................... 2
Accessories........................................................................................................... 3
Battery................................................................................................................... 5
Before taking sensor into use................................................................................ 9
Indicators............................................................................................................. 10
Capturing image with one sensor........................................................................ 11
Using two sizes of sensors.................................................................................. 13
Sharing sensor with other users.......................................................................... 15
Taking images with USB cable connected.......................................................... 17
Recharging the battery........................................................................................ 18
Recommended exposure times .......................................................................... 19
Care instructions.................................................................................... 21
3.1 Cleaning the Sigma unit ...................................................................................... 21
3.2 Handling the device............................................................................................. 22
Trouble shooting.................................................................................... 23
4.1 Diagnosing image quality problems .................................................................... 23
4.2 Diagnosing equipment specific problems............................................................ 24
General information ............................................................................... 27
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
Technical specifications........................................................................ 33
6.1
6.2
6.4
6.3
6.5
6.6
6.7
Manufacturer’s liability......................................................................................... 27
Markings and graphics symbols.......................................................................... 27
Main label............................................................................................................ 30
Manuals............................................................................................................... 30
Disposal .............................................................................................................. 30
Warnings ............................................................................................................. 31
Notice of wireless LAN usage ............................................................................. 31
FCC certification.................................................................................................. 32
General ............................................................................................................... 33
Dimensions ......................................................................................................... 33
RF exposure info................................................................................................. 34
Sensor unit .......................................................................................................... 34
Ambient conditions.............................................................................................. 35
Image acquisition system requirements.............................................................. 35
Electromagnetic Compatibility (EMC) tables....................................................... 36
Appendix 1, Sigma M products and accessories................................ 41
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1 Sigma M system
1 Sigma M system
1.1
INTRODUCTION
Thank you for purchasing Instrumentarium Dental Sigma M digital
intraoral sensor.
The Sigma M sensor is intended for dental x-ray imaging. Sigma M
produces high quality digital X-ray images of teeth and adjacent
structures instantly without the need for film or chemicals. It allows the
user to view, enhance, store, send and print images using the
CliniView imaging software.
Two sensor sizes are available for various dental X-ray imaging
needs.
Size 1: 1580 x 1050 pixel
Fig 1.1.
Size 2: 1916 x 1358 pixel
Sigma M sensor size 1 and 2.
Sigma M sensor type size 1 (S1) is designed for taking anterior,
periapical and periodontic images. The purpose of Sigma M sensor
type size 2 (S2) is to capture bitewing and horizontal periapical
images. The sensor type is marked on the main label (see chapter
Main label for details).
The use of Sigma M system requires intraoral X-ray unit and a
computer with a wireless network (Wi-Fi/Wlan) connectivity. USB port
can be used for configuring the sensor or when the wireless (Wi-Fi/
Wlan) is temporarily unavailable.
It is assumed here that the sensor system is properly installed and
configured to operate in a desired WLAN network. See Sigma M
installation manual and this Sigma M user manual for instructions.
The Sigma M sensor is battery operated. The device is supplied with a
rechargeable battery installed. Make sure that the battery is recharged
prior the use of the sensor.
Instructions for the Sigma M use include the following manuals:
– Sigma M User Quick Guide
– Sigma M User Manual
– CliniView User Manual
Read all the instructions carefully before the Sigma M use.
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1 Sigma M system
1.2
MAIN PARTS OF THE SIGMA M DEVICE
CONNECTORS
BATTERY COVER
Magnetic
mounting
guide
Main label
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1 Sigma M system
1.3
ACCESSORIES
Sigma M Charger
•
included in the sales package
•
available in various type for
local mains voltage and
approvals. Consult the local
distributor for correct type, If
spare part is needed.
Magnet Mount
•
included in the sales package
•
the magnet place can be
decided by the user
(see page 9)
•
can be used for mounting the
device during the image
capture procedure or during
storage
•
adhesive tape included for
attaching the mount on tube
head
Wall mount set
•
included in the sales package
•
for storage when not used
and during battery charge
•
screws for wall mounting
included
WARNING!
Do not place the magnet on the
cover of PC and monitor, or
nearby a pacemaker.
USB cable
•
included in the sales package
WARNING!
Use only USB cable delivered with
the device to ensure proper
operation
according
to
specification.
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1 Sigma M system
Sigma M Sensor holders
(optionally)
•
available separately
•
consult your local dealer for
details
KerrHawe Sensor holders
(optionally)
•
available separately
•
consult your local dealer for
details
Hygienic covers
•
available separately
SENSOR HOLDERS
When taking intraoral images it is necessary to keep the sensor
parallel to the tubehead. Correct positioning is assisted with the help
of KerrHawe or Sigma M sensor holders.
The sensor must be covered with a hygienic cover every time it is
used. Only use hygienic covers similar to hygienic covers delivered
with the Sigma M system by Instrumentarium Dental.
NOTE!
The covers are protected against touch but they are not sterile.
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1 Sigma M system
SENSOR CABLE PLACEMENT
To prevent the patient biting the sensor cable, lead the cable
alongside the holder as instructed below:
CORRECT
1.4
•
INCORRECT
BATTERY
Sigma M Battery, Spare part number: 5169795
WARNING!
Replace the battery only with Instrumentarium Dental Sigma M
battery, part no. 5169795. Charging with equipment other than the
original Sigma M charger may cause heat generation or cell leakage.
Use of another battery may present a risk of fire or explosion. See
instructions for replacing the battery.
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1 Sigma M system
CHECKING BATTERY STATUS
The remaining battery charge level is displayed in CliniView, next to
the sensor status, when the sensor is in image capture mode.
The battery status can be checked also by clicking Help/system info
(Sigma M sheet), when the sensor is in image capture mode.
If the battery´s voltage drops below 3700 mV, the CliniView software
informs the user about low battery. Normal operation voltage is 37004200 mV. Below 3500 mV the sensor does not turn on.
REPLACING BATTERY
If battery operation has drastically decreased, a change of battery is
recommended. Battery capacity will decrease over time.
The battery should be replaced at intervals of 1-3 years or after 500
recharge cycles. Replace only with original Sigma M battery (order
part number 5169795). Opening the battery cover must be done so
that the cover does not get damaged.
Switch off the Sigma M sensor and open the battery cover screw
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1 Sigma M system
Push the cover in the direction indicated by an arrow and remove
the cover carefully. Make sure not to bend the cover when
removing it. Disconnect the battery cable and dispose of the
battery properly.
Replace with a new battery. Do not shortcut the poles of the
battery, it may cause danger of explosion.
CAUTION!
The battery used in this device may present a fire or a chemical burn
hazard if mistreated. Do not dissemble, heat to 100°C (212 F) or
incinerate.
NOTE!
The battery is harmful to the environment and so it must be disposed
of in accordance with local regulations.
WARNING!
The battery may explode if two poles are short-circuited.
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1 Sigma M system
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2 Capturing intraoral images
2 Capturing intraoral images
2.1
BEFORE TAKING SENSOR INTO USE
Refer to chapter “Technical Specifications” and “Image Acquisition
System Requirements” for hardware requirement.
Make sure the CliniView software (version 6.4.1 or later) has
been installed properly.
Make sure the necessary WLAN equipments have been installed
and WLAN network is working properly.
Make sure Sigma M sensor(s) has been properly configured to
operate in the desired WLAN network. See CliniView installation
manual and Sigma M installation manual for details.
The sensor unit is rechargeable battery operated. It is recharged
with the included Sigma M charger. A daily recharge is
recommended. Approximately 200 exposures can be taken with a
fully recharged battery. Before using the sensor, make sure the
battery has been recharged.
Connect the charger connector to the Sigma M charger. The
sensor cannot be used when recharging batteries.
Disinfect the sensor and the cable before the patient work.
NOTE!
Use the magnet included in the sales package to mount the sensor on
the X-ray tube head for ergonomic and efficient workflow.
NOTE!
Ask your sensor dealer for holder offering designed for the Sigma M
sensor.
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2 Capturing intraoral images
2.2
INDICATORS
Device status indicator
Indicator
Orange
Green
Green blinking
Orange blinking
Device status
Power on
Ready for
image capture
Image
integration
Image
transmission
Battery status indicator
Indicator
Orange blinking
Orange blinking
fast
Orange
Off
Battery status
Low battery (a
few images can
still be
captured to
complete the
patient)
Critically low
battery (image
capturing not
recommended)
Battery
charging
Charge
complete,
battery is OK
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2 Capturing intraoral images
2.3
POWER
SWITCH
CAPTURING IMAGE WITH ONE SENSOR
It is assumed here that one, either size 1 or size 2 sensor, is selected
from the Installed device -menu on the CliniView software. It is also
assumed that this sensor is selected as a default sensor device using
the Tools-Intra-Sigma M settings -menu of the CliniView software. See
the Sigma M installation manual for details.
Start CliniView software and select a patient.
Switch on the sensor by pressing the sensor power switch.
NOTE!
For efficient work flow the sensor and Cliniview capture mode can be
turned on well before inserting the sensor into the patient's mouth.
Consequently the system will be immediately ready for capture when
the sensor is in place. If you forget to power the sensor at the
beginning of the workflow you can do it also later before the image
capture.
Protect the sensor with a hygienic cover and place the sensor on
to the holder.
•
•
Hold the hygienic cover with the paper side pointing downwards.
Carefully insert the sensor between the white tab and the base
paper.
Peel away the upper transparent protective foil completely.
Peel away the base paper completely from the underside.
•
•
Start image capturing in Cliniview by pressing the Start intraoral
image capturing -button.
NOTE!
The exposure must be made within 15 minutes maximum after clicking
the “Start intraoral image capturing” button, depending on the time-out
setting in the CliniView software. As well as the CliniView time-out
setting, the sensor also has a power off timer.
NOTE!
The other image capture icon can be used for capturing image using
the template if several image are taken in series.
Position the sensor in the patient´s mouth. The sensor unit can be
either on the patient's chest or with the magnetic mounting on the
side of the X-ray unit tube head. Position the Intraoral X-ray unit
as appropriate.
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2 Capturing intraoral images
NOTE!
Make sure that the device status indicator illumates green before
making the exposure.
Make the exposure by pressing the exposure button of the x-ray
unit. Blinking status indicator on the device indicates image
transfer.
NOTE!
If several images are captured in series, do not switch the sensor off
between the exposures. The auto power off will turn the sensor off, if
the sensor is not used approximately in 10 minutes.
After the image capturing click Abort image capturing button in
CliniView.
When capturing is finished switch the sensor off, remove
disposable covers and disinfect the sensor if necessary.
WARNING!
During the exposure cycle radiation the control protection guidelines
must be observed.
WARNING!
Minimize the number of running programs before image capturing to
ensure the necessary operating system resources for the process.
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2 Capturing intraoral images
2.4
USING TWO SIZES OF SENSORS
It is assumed here that both sensor size 1 and sensor size 2 have
been installed and enabled from the installed device -menu on the
Cliniview software. It is also assumed that the appropriate sensor
device has been configured as the default sensor device using the
Tools - Intra-Sigma M settings -menu of the Cliniview software. See
the Sigma M installation manual for details.
When both sensor sizes are installed, image capturing icons for both
size 1 and size 2 sensors are displayed in the CliniView software. The
image capturing can be started for either one or two sensors.
Buttons from left to right:
- Image capturing with template (size 2)
- Quick image capturing (size 2)
- Image capturing with template (size 1)
- Quick image capturing (size 1)
The image capture can be started as described in the previous
chapter, with either of the sensors installed in the system. It is also
possible to use both size 1 and size 2 sensor during one image
capture session.
NOTE!
Both sensors can be activated simultaneously by clicking image
capture icon of both sensor before exposure. The sensor that receive
x-ray sends the image to CliniView. The other sensor remains ready
for exposure.
If two sensors are activated simultaneously, there will be two sensor
status bars on the PC screen.
POWER
SWITCH
Start CliniView software and select a patient.
Switch on the sensors to be used by pressing the sensor power
switch.
Protect the sensor with a hygienic cover and place the sensor to
the holder.
Start image capturing in Cliniview by pressing the Start intraoral
image capturing -button.
Position the sensor in the patient´s mouth. The sensor unit can be
either on patient’s chest or with the magnetic mounting on the
side of the x-ray unit tube head. Position the Intraoral x-ray unit as
appropriate.
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2 Capturing intraoral images
NOTE!
Make sure that the sensor, which is intended to use is
powered on and ready for image capture before
exposure. Status indicator illuminates green when the
sensor is ready.
Make the exposure by pressing the exposure button of the x-ray
unit. Blinking status indicator on the device indicates image
transfer.
NOTE!
If several images are captured in series, do not switch the sensor off
between the exposures. The auto power off will turn the sensor off, if
the sensor is not used approximately in 10 minutes.
After the image capturing click Abort image capturing button in
CliniView.
When capturing is finished switch the sensor off, remove
disposable covers and disinfect the sensor if necessary.
WARNING!
During the exposure cycle radiation the control protection guidelines
must be observed.
WARNING!
Minimize the number of running programs before image capturing to
ensure the necessary operating system resources for the process.
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2 Capturing intraoral images
2.5
SHARING SENSOR WITH OTHER USERS
It is assumed here that two or more workstations in different rooms
have been configured to operate in the same Sigma M network.
It is possible to use default sensor assignment for each room or
alternatively select the sensor to be used from a list of available
sensors in each image capture session. Select "Use preselected
sensors" from Tools - Intra - Sigma M settings -menu to use default
sensor assignment. See Sigma installation manual and user manual
for details.
NOTE!
Several rooms can select one shared sensor as their default sensor
device. The sensor allows only one user at a time. If the sensor has
been previously used by someone else, the user is asked to confirm
selection when activated to avoid unintentional connection to the
sensor.
POWER
SWITCH
Start CliniView software and select a patient.
Switch on the sensors to be used by pressing the sensor power
switch.
Protect the sensor with a hygienic cover and place the sensor on
to the holder.
Start image capturing in CliniView by pressing
the Start intraoral image capturing button of
the appropriate sensor.
If default sensor assignment -mode is not used,
select the desired sensor from the Select device dialogue that
opens. If the sensor has been transferred from one room to
another, the user will be notified that the sensor was previously
assigned to another workstation.
Position the sensor in the patient´s mouth. The sensor unit can be
either on patient’s chest or with the magnetic mounting on the
side of the x-ray unit tube head. Position the Intraoral x-ray unit as
appropriate.
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2 Capturing intraoral images
NOTE!
Make sure that the device status indicator illuminates
green before making the exposure.
Make the exposure by pressing the exposure button of the x-ray
unit. Blinking status indicator on the device indicates image
transfer.
NOTE!
If several images are captured in series, do not switch the sensor off
between the exposures. The auto power off will turn the sensor off, if
the sensor is not used approximately in 10 minutes.
After the image capturing click Abort image capturing button in
CliniView.
When capturing is finished switch the sensor off, remove
disposable covers and disinfect the sensor if necessary.
WARNING!
During the exposure cycle radiation the control protection guidelines
must be observed.
WARNING!
Minimize the number of running programs before image capturing to
ensure the necessary operating system resources for the process.
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2 Capturing intraoral images
2.6
TAKING IMAGES WITH USB CABLE
CONNECTED
NOTE!
The Windows XP operating system will open a Windows Explorer
dialogue when Sigma M is connected via USB. Close this window.
POWER
SWITCH
Start CliniView software and select a patient
Switch on the sensor by pressing the sensor power switch.
Protect the sensor with a hygienic cover and place the sensor on
to the holder.
Start image capturing in CliniView by pressing
the Start intraoral image capturing button.
Position the sensor in the patient´s mouth. The
sensor unit can be either on patient’s chest or
with the magnetic mounting on the side of the x-ray unit tube
head. Position the Intraoral x-ray unit as appropriate.
NOTE!
Make sure that the device status indicator illuminates
green before making the exposure.
Make the exposure by pressing the exposure button of the x-ray
unit. Blinking status indicator on the device indicates image
transfer.
NOTE!
If several images are captured in series, do not switch the sensor off
between the exposures. The auto power off will turn the sensor off, if
the sensor is not used approximately in 10 minutes.
ro
After the image capturing click Abort image capturing button in
CliniView.
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2 Capturing intraoral images
When capturing is finished switch the sensor off, remove
disposable covers and disinfect the sensor if necessary.
WARNING!
During the exposure cycle radiation the control protection guidelines
must be observed.
WARNING!
Minimize the number of running programs before image capturing to
ensure the necessary operating system resources for the process.
2.7
Before unplugging the USB cable, click the “Unplug or eject
hardware” icon on the desktop. Choose Sigma M and then click
OK. “Safely remove hardware” icon on the toolbar, Sigma M = Xray device.
RECHARGING THE BATTERY
The battery is recharged with the charger supplied with the device.
More than 200 image captures can be made with a fully charged fresh
battery. Low battery status is indicated with a flashing orange LED. A
few images can still be taken to complete the patient until the orange
LED starts flashing fast. Fast flashing indicates critically low battery
and image capturing is no more recommended.
Charge the empty battery by first plugging the charger cable in to the
sensor unit, and then plugging in to the mains. Charging takes about 2
hours and it is indicated with an orange LED that switches off when
charging is complete.
The device cannot be used when the charger is connected.
WARNING!
Charging with equipment other than the original Sigma M charger may
cause heat generation or cell leakage.
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2 Capturing intraoral images
2.8
RECOMMENDED EXPOSURE TIMES
The table below provides guidelines for exposure times for an average
DC generator at 70 kV and 7 mA. These values might need to be
adjusted for specific generator characteristics (kV, mA).
70 kV
SSD
Maxillary Incisor
Maxillary Cuspid
Maxillary Molar
Mandibular Incisor
Mandibular Cuspid
Mandibular Molar
Bitewing
Adult Adult Child Child
9”
12”
9”
12”
0,100
0,100
0,160
0,100
0,100
0,125
0,125
0,200
0,200
0,320
0,200
0,200
0,250
0,250
0,050
0,050
0,080
0,050
0,050
0,063
0,063
0,100
0,100
0,160
0,100
0,100
0,125
0,125
NOTE!
The selected time varies as the square of the distance. The dose
should be increased if the distance from the sensor to the focal spot
increases.
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2 Capturing intraoral images
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200150 rev 3
3 Care instructions
3 Care instructions
The user must perform the following inspections monthly:
– Visually check that all visible labels are intact and legible
– Check Sigma M sensor cable(s) for wear and damages
– Inspect a test image for sensor defect
NOTE!
The sensor unit must not be opened or repaired by the user. There are
no user serviceable parts in the equipment. In case of malfunction
always contact your dealer.
3.1
CLEANING THE SIGMA UNIT
The Sigma M sensor unit contains sophisticated electronics. Treat the
device with care. Use a cloth moistened in mild cleaning solution
(soap) or mild disinfectant to clean the Sigma M unit.
Do not let any water or cleaning fluid to enter the device. Always follow
the instructions of the cleaning agent.
Use a new disposable hygienic cover for every sensor usage. If
required the sensor can be immersed in disinfectant solution. Follow
the disinfectant instructions carefully. However immersion should not
exceed 12 hours. Be carefull not to let any disinfectant to enter the
sensor unit.
Do not use aggressive chemicals that may damage the sensor (i.e.
hypochlorite or other bleaching chemicals). As a guideline the sensors
withstand CIDEX (glutaraldehyde 2,2 - 2,6% and inert components)
disinfecting solution.
WARNING!
DO NOT:
- Sterilize the sensor using autoclave or an UV oven
- Immersion in bleach or alcohol content solution
- Clean the sensor using in-appropriate instruments
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3 Care instructions
3.2
HANDLING THE DEVICE
WARNING!
DO NOT:
- Sterilize the sensor using autoclave or an UV oven
- Immersion in bleach or alcohol content solution
- Clean the sensor using in-appropriate instruments
- Pinch or bite sensor or cable
- Pull or bend cable with force
- Unplug charger or USB cable by pulling cable out
- Remove hygienic cover by pulling the cable
- Let sensor fall down
- Touch the connector contacts by hand
- Open sensor unit covers (except battery cover)
- Do not touch open connectors by hand, to avoid malfunctions due to
electrostatic discharge
- Do not expose the device to flammable vapour or anesthesia gas.
•
•
•
Use the sensor with a proper sensor holder
Make sure the sensor never strikes a hard surface.
Arrange sensor cable smoothly in its storage place when not in
use
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4 Trouble shooting
4 Trouble shooting
4.1
DIAGNOSING IMAGE QUALITY PROBLEMS
High quality images with sharp contrast and fine details give optimum
diagnostic information. Images of lesser quality are usually a result of
one or more common problems, which are discussed here.
NOTE!
If using the system in an extremely high electromagnetic environment,
some interference in image quality may occur.
PROBLEM
Images are too
grainy and light
Images are too
dark
Lack of image
contrast
POSSIBLE CAUSE
REMEDY
1 Exposure factors
(kV, mA, s) used
are too low
1 Increase exposure
factors (see ch 2.8
recommended
exposure times)
2 Image
adjustments have
not been
performed
2 Adjust the image
brightness,
contrast and
gamma using
CliniView software
3 Incorrect
integration time or
generator type
(AC/DC)
3 Set the generator
type and the
integration time for
AC generator in
CliniView
1 Exposure factors
used are too high
1 Decrease
exposure factors
2 Image
adjustments have
not been
performed
2 Adjust the image
brightness,
contrast and
gamma using
CliniView software
1 Image
adjustments have
not been
performed
1 Adjust the image
contrast using
CliniView software
2 Exposure factors
(kV, mA, s) used
are not optimal
2 Increase exposure
factors (see ch 2.8
recommended
exposure times)
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4 Trouble shooting
PROBLEM
Images are
blurred
Images are
burned out
POSSIBLE CAUSE
REMEDY
1 The patient moved
1 Prevent patient
movement
2 The X-ray source
moved
2 Prevent X-ray unit
movement or have
the unit serviced
3 Incorrect
integration time
3 Set the integration
time in CliniView to
be longer than the
exposure time
1 Excessive
exposure time
1 Set shorter
exposure time
2 Change a long
cone on the X-ray
unit
4.2
DIAGNOSING EQUIPMENT SPECIFIC
PROBLEMS
PROBLEM
Sensor cannot be
powered
Image capturing
icons are missing
POSSIBLE CAUSE
REMEDY
1 The battery is
empty
1 Recharge the
battery
2 The battery is not
inside the
electronics
2 Insert the battery
1 Sigma M is not
selected as an
“installed device”
in CliniView
1 Select Sigma M as
an installed device
from Tools menu
in CliniView
2 The patient is not
selected in
CliniView
2 Select the patient
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4 Trouble shooting
PROBLEM
POSSIBLE CAUSE
REMEDY
Image capturing
cannot be started
1 The battery is
empty (The battery
status indicator is
blinking)
1 Recharge the
battery
2 The sensor is not
powered
2 Power up the
sensor
3 The wireless
network is not
available
3 Refer to
installation manual
or contact IT
support
4 The gainfile is not
installed
4 Use Gain Installer
to install the
gainfile
5 Used sensor is not
set as default
5 Set the used
sensor as a default
in Tools menu in
CliniView
1 Sigma M is off
1 Switch on the
sensor
2 Wrong sensor
switched on
2 Switch on the
sensor assigned to
the workstation
3 WLAN network not
set up
3 Set up the wireless
network according
to the installation
manual
4 Another WLAN
network is in use
4 Choose a WLAN
network used for
Sigma M
5 WLAN network is
down because:
– Access point
not connected
– Access point
not powered
– LAN cable not
connected
5 Connect USB
dongle, Power
access point,
Connect LAN
cable
CliniView cannot
find the sensor /
Sensor is not
ready for the
image capturing
More
information
from
network
administrator
or
adapter
manuafacturer
6 Check SSID, IP
address and
encryption
6 WLAN settings
are incorrect
7 Charger
is connected
7 Disconnect the
charger
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4 Trouble shooting
PROBLEM
POSSIBLE CAUSE
REMEDY
1 Use only the
charger
accompanied with
a sensor
Charging the
battery does not
start / red battery
status indicator
illuminates
1 Wrong charger
used
Image capturing
icon cannot be
activated
1 Patient not
selected
1 Select the patient
2 Sigma M not
selected in CV
installed devices
list
2 Select the correct
Sigma M sensor
type in CV
installed devices
list
3 Sensor is not
preselected
3 Click Select
sensor and assign
the sensor
4 Gain file not
installed
4 Install gain file
Image capturing
fails (image
transfer does not
start after the
exposure)
1 Unactivated
sensor has been
exposed
1 Retake an image
with an activated
sensor
Image transfer
fails (image
transfer starts
after the
exposure, but the
image does not
appear on the
screen)
1 Network error
1 Reload the image
by restarting
image capturing
mode in CliniView
2 Charger not
plugged to the
mains
2 Plug the charger to
the mains
WARNING
Do not shut off the
sensor.
Do
not
connect USB cable.
2 Reset the Access
Point
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200150 rev 3
5 General information
5 General information
5.1
MANUFACTURER’S LIABILITY
When installing the Sigma M system it is important to observe all
warnings and precautions described in this manual. As a manufacturer
we can only assume liability for safe and reliable operation of the
Sigma M system when:
•
•
•
•
•
PC installation was performed according to manuals supplied
with the PC
CliniView PC software is installed and used according to the
Installation & User Manual for CliniView Software.
Sigma M system is installed and used according to the
Installation & User Manual for Sigma M system
Maintenance and repairs are performed by a qualified Sigma M
Dealer and
Original or authorized replacement parts are used.
If service on the equipment is performed, a work order describing the
type and extent of repair must be provided by the service technician.
This must contain information of changes of nominal data or work
range performed. The work order must furthermore indicate the date
of repair, the name of the company concerned and a valid signature.
The user should keep this Service Report for future reference.
If you have any problems or difficulties when capturing images, please
refer to troubleshooting in the user manual.
Please find the electromagnetic compatibility tables according to IEC
60601-1-1-2 Ed 2 in this Sigma M user manual.
Use only USB cable delivered with the device to ensure proper
operation according to specification.
5.2
MARKINGS AND GRAPHICS SYMBOLS
The following markings are used in this manual:
NOTE!
Contains useful information for the reader about the unit and its use.
CAUTION!
Contains important instructions. If these instructions are not observed,
malfunction of the unit or damage to the unit or other property may
occur.
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5 General information
WARNING!
Contains warnings and instructions about the safety of the unit. If
these warnings are not respected, serious risks and injury may be
caused to the patient and operator.
The following symbols are used in the Sigma M device and in the
manuals:
Attention, consult accompanying documents. Contains
warnings and instructions about the safety of the unit. If
these warnings are not observed, serious risks and
injury may be caused to the patient and operator.
If the unit has CE-marking it is CE-marked according to
the Medical Device Directive 93/42/EEC.
USB connection
DC connector
Indoor, dry location use only
Power
Non-ionizing radiation
The device complies with Part 15 of the FCC Rules.
IP21
The degree of protection provided by the sensor unit
enclosure against solid objects greater than 12.5 mm in
diameter and against vertically dripping water.
This symbol indicates that the waste of electrical and
electronic equipment must not be disposed as unsorted
municipal waste and must be collected separately.
Please contact an authorized representative of the
manufacturer for information concerning the
decommissioning of your equipment.
The instructions in this manual contain essential information
necessary for the installation and use of the Sigma M system. As
manufacturer we strongly recommend that you read this manual
before installation and use.
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200150 rev 3
5 General information
The following abbreviations may be used in this manual:
PC
Personal computer
HD
Hard disk
Hz
Herz; cycles per second
MHz
Millions of hertz
CPU
Central processing unit (computer)
RAM
Random access memory
MB
Mega bytes
GB
Giga bytes
CD-R
Compact disc (recordable)
CD-RW
Compact disc (re-writable)
DVD-RW
Digital Versatile Disc (re-writable)
HDD
High density drive
PCI
Peripheral Component Interconnect
LAN
Local Area Network
USB
Universal Serial Bus
MAC
Medium Access Control
WLAN
Wireless local area network
Wi-Fi
Wireless network compliant with IEEE802.11
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5 General information
5.3
MAIN LABEL
The sensor model Sigma M is available in two product type. The exact
type of the device is shown on the main label.
Fig 5.1.
Label on CE-marked device
MAC is a unique MAC-address of the internal WLAN terminal.
Type
Description
Part number
S1
Sensor size 1
900003
S2
Sensor size 2
900004
The main label with the serial number of the product of the device is
attached to the battery cover. The battery cover must not be replaced
by an unauthorized person. Contact your local dealer for servicing a
damaged cover if needed.
5.4
MANUALS
The following manuals and documents are shipped with the Sigma M
system:
•
•
•
•
•
5.5
Sigma M User Quick Guide
Sigma M Installation Manual
Sigma M User Manual
CliniView User Manual
CliniView Installation Manual
DISPOSAL
At the end of useful working life of the device, its spare and
replacement parts and accessories make sure that you follow all local,
national and international regulations regarding the correct and safe
disposal and/or recycling of the device, its spare and replacement
parts and accessories.
The device and its spare and replacement parts and accessories may
include parts that are made of or include materials that are nonenvironmentally friendly or hazardous. These parts must be disposed
of in accordance with all local, national and international regulations
regarding the disposal of non-environmentally friendly or hazardous
materials.
ro
The following hazardous materials and substances can be found in the
device its spare and replacement parts and assemblies:
App
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5 General information
– lead (Pb): sensor, circuit board
The locations of all the spare and replacement parts and assemblies
listed above can be found in the service and/or installation manual
supplied with the device.
5.6
•
WARNINGS
Minimize the number of running programs before image capturing
to ensure the necessary operating system resources for the
process.
Computer should only be connected to grounded outlet
Do not forcefully bend sensor cables. Avoid mechanical wear and
stress (pulling the cable)
Use only the power supply specified by the manufacturer
Make sure that the Ready LED illuminates before making an
exposure.
Don't sterilize the sensor using autoclave or UV oven
Use a disposable hygienic cover or disinfect the sensor after
every patient
The battery is harmful to the environment and so it must be
disposed of in accordance with local regulations.
The electronics box must not be opened or repaired by the user
Do not allow water or other cleaning liquids to enter the
electronics
Connect the system only to a PC conforming with IEC60950 or
IEC60601-1
•
•
•
•
•
•
•
•
•
•
5.7
NOTICE OF WIRELESS LAN USAGE
WLAN operation is based on emitting and receiving RF energy.
This equipment complies with European R & TTE directives, and may
be operated without a licence in Europe (ETSI). The declaration of
conformity can be consulted at Instrumentarium Dental. Although this
and other use environment devices comply with CISPR requirements
for RF emissions, interference may still occur.
Monitor the performance of the wireless link. If it behaves in a strange
or unexpected way that may endanger patient safety, use the USB
connecting cable until the problem is resolved.
Hereby, Instrumentarium Dental, declares that this Sigma M sensor is in compliance with the essential requirements and other
relevant provisions of Directive 1999/5/EC.
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5 General information
5.8
FCC CERTIFICATION
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions:
This device may not cause harmful interference
This device must accept any interference received, including
interference that may cause undesired operation.
Sigma M sensor
Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate
the equipment.
NOTE!
This equipment has been tested and found to comply with the limits for
Class B digital device, pursuant to Part 15 or the FCC Rules. These
limits are designed to provide reasonable protection against harmful
interference in residential installation. This equipment generates, uses
and can radiate radio frequency energy and, if not installed and used
in accordance with the instruction manual, may cause harmful
interference to radio communications. However, there is no guarantee
that interference will not occur in a particular installation. If this device
does cause harmful interference to radio or television reception, which
can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the
following measures:
- reorient or relocate the receiving antenna
- increase the separation between the equipment and receiver
- connect the equipment into an outlet on a circuit different from that to
which the receiver is connected
- consult the dealer or an experienced radio/TV technician for help
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200150 rev 3
6 Technical specifications
6 Technical specifications
6.1
GENERAL
Manufacturer´s quality
system:
Electrical and Mechanical
safety:
Patient connection (sensor):
Sensor technology:
IMAGE QUALITY
Resolution:
Grayscale:
Holders:
ISO 9001, ISO 13485
Medical Equipment with
respect to electrical
shock, fire and
mechanical hazards
only in accordance with UL60601,
CAN/CSA C22.2 no 601.1
According to IEC 60601-1, CE models
marked according to the Medical
Device Directive 93/42/EEC (Device
classification: II b),
Mobile sensor unit that is IEEE
802.11b (WLAN) compliant
BF-type
CMOS Active Pixel technology
(CMOS APS)
26.3 lp/mm (theoretical)
4096 gray levels.
A full set of color coded KerrHawe and
Sigma M sensor holders, with easy
instructions, for comfortable and
accurate positioning.
SOFTWARE MAIN
FEATURES
Operating system:
Operating software:
Full Mouth Series:
File sizes:
X-ray shield in the sensor:
Windows 2000 or XP (SP2)
CliniView version 6.4 or later
FMS, user defined
3,17 MB, uncompressed file,Sensor
size1 4,96 MB, uncompressed
file,Sensor size2
Lead (Pb)
6.2
DIMENSIONS
Outer dimensions:
Active image area:
Sensor unit:
Sensor size 1:
Sensor size 2:
Sensor size 1:
Sensor size 2:
102 x 60 x 22 mm
26 x 37 mm
31 x 44 mm
30.02 x 19,95 mm2
36,48 x 25,84 mm2
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6 Technical specifications
Sensor shape:
PIXEL SIZE
Sensor size 1:
Sensor size 2:
Sensor cable length
6.3
Four rounded corners, two corners with
greater radius for better patient comfort in
Sensor size 2.
19 µm x 19 µm
19 µm x 19 µm
1580 x 1050 pixels
1916 x 1358 pixels
Sensor size 1:
Sensor size 2:
40 cm
40 cm
SENSOR UNIT
Sensor unit box:
PC connection:
USB:
USB cable length:
General applied part
(sensor):
Battery type:
Battery capacity:
Vertically or horizontally mounted on
desktop or wall mounted. A Sigma M Sensor
that is connected to the sensor unit can be
shared between rooms without need to
switch off the PC.
802.11b/g 2.4 GHz Access Point or USB
USB 2.0 Full speed, mini USB-B port
connector, 500 mA.
maximum 3 meters (9,8 feet), ferrite
required.
BF type
Rechargable lithium Polymer battery
1000 mAh (correspond approx 200 image
capture). (Battery life expectancy:
500 cycles C/2, 20°C) in WLAN use.
External power supply: DC connector, 6V, center pin positive
6.4
RF EXPOSURE INFO
WLAN:
Frequency:
Output power:
Separation:
According to IEEE 802.11b
2400 MHz - 2483 MHz
max 0,25 W (FCC)
max 0,1 W (ETSI)
Keep the sensor unit min. 20 cm away from
the patient
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200150 rev 3
6 Technical specifications
6.5
AMBIENT CONDITIONS
The Sigma M unit
Transportation and storage
temperature:
Operating temperature:
Relative humidity (storage):
Water tightness:
-40°...+60°C (-40F...+158F),
note battery discharge
during long storage and high
temperature
+10°...+40°C (+50F...+104F)
10-93%
IP67 (sensor)
IP21 (sensor unit)
The battery
Charge Temperature
Charge:
0°...+45°C (+32F...+113F)
Storage Temperature and time to 1 Year at
prevent self discharge
-20°...+20°C (-4F...+68F)
3 Month at
-20°...+45°C (-4F...+113F)
1 Month at
-20°...+60°C (-4F...+140F)
Materials
Sensor cover
Sensor cable
Hygienic cover
6.6
PA
PUR
Ethylene Methyl Acrylate
Copolymer
IMAGE ACQUISITION SYSTEM REQUIREMENTS
The Sigma M acquisition system consists of Sigma M sensor and PC
hardware. Sigma M sensor is a medical device.
WARNING!
If a IEC 60950-compliant (non-medical) PC is used, it must not be
brought in to the patient environment (see Sigma M installation
manual for details).
WARNING!
Do not bring open (unconnected) USB cable to the patient area. If the
sensor is used with USB cable in the patient area, the user must make
sure that system leakage current does not exceed IEC/ISO 60601-1-1
limits (see Sigma M installation manual for details).
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6 Technical specifications
Sigma M IMAGE ACQUISITION SYSTEM REQUIREMENTS
Electrical safety
IEC 60950 for office use
or IEC/ISO 60601-1 (medical PC)
Processor
Pentium® 600MHz or better (Windows
2000)
Pentium® 600MHz or better (Windows
XP)
Hard disk
10 GB
CD-ROM
Yes
Keyboard
Yes
Mouse
Yes
USB port
Yes
Accessories
Audiocard and speakers optional
Operating system
Windows® 2000
Windows® XP (SP2)
See Microsoft Windows System
Requirements
Main memory (RAM)
Windows® 2000 and XP: 256 MB or more
Monitor
15” or bigger
Archive
CD-R
DAT
Iomega®
Jazz®
MOD
WLAN network
adapter
IEEE 802.11 b compatible (built in, USB,
access point or equivalent)
6.7
ELECTROMAGNETIC COMPATIBILITY (EMC)
TABLES
These Electromagnetic Compatibility tables according to
IEC 60601-1-2 Ed 2 in chapter 7.5 consists of:
WARNING!
When used Sigma M adjacent to other equipment such configuration
should be carefully observed to ensure that electromagnetic
interference (EMI) does not degrade performance.
The use of Sigma M attached to Instrumentarium Dental Focus x-ray,
as presented in this user manual, has been verified by the
manufacturer.
App
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200150 rev 3
6 Technical specifications
WARNING!
USE LIMITATION: External components: The use of accessories,
transducers, and cables other than those specified may result in
degraded
ELECTROMAGNETIC
COMPATIBILITY
of
the
EQUIPMENT and/or SYSTEM.
WARNING!
Portable and mobile RF communications equipment can affect the
system.
The Sigma is suitable for use in the specified electromagnetic environment. The purchaser or
user of the Sigma should assure that it is used in an electromagnetic environment as described
below:
Emissions Test
Compliance
Electromagnetic Environment
Radio-Frequency
Emissions
CISPR11
Group 2
The Sigma M must emit electromagnetic energy in order
to perform it’s intended function. Nerby electronic
equipment may be affected.
Radio-Frequency
Emissions
CISPR11
Class B
The Sigma 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
emissions
IEC 61000-3-2
Class A
The Sigma 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.
Complies
The Sigma 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.
IEC 61000-3-2
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Table 6.1 Electromagnetic emissions IEC 60601-1-2 Ed 2.
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37
6 Technical specifications
Recommended Separation Distances for Portable and Mobile RF Communications
Equipment IEC 60601-1-2
Frequency of
Transmitter
Equation
150KHz to 80 MHz
d =[
3,5
] P
V1
80 MHz to 800 MHz
d =[
3,5
] P
E1
800 MHz to 2,5 GHz
d =[
] P
E1
Rated Maximum
Output Power of
Transmitter (watts)
Separation Distance
(meters)
Separation Distance
(meters)
Separation Distance
(meters)
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1.17
1.17
2.34
10
3.69
3.69
7.38
100
11.67
11.67
23.34
Table 6.2 Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2
Ed 2.
App
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200150 rev 3
6 Technical specifications
Sigma M is suitable for use in the specified electromagnetic environment. The purchaser or user
of Sigma M should assure that it is used in an electromagnetic environment as described below:
Immunity Test
IEC 60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 2, 4, 6 kV for
contact discharge
± 2, 4, 8 kV for air
discharge
± 2, 4, 6 kV for
contact discharge
± 2, 4, 8 kV for
air discharge
Floors are wood, concrete, or
ceramic tile, or floors are covered
with synthetic material and the
relative humidity is at least 30
percent.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 2 kV for power
supply lines
Mains power quality is that of a
typical commercial and/or hospital
environment
± 1 kV for
input/output
lines
± 1 kV for
input/output
lines
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common
mode
± 1 kV differential
mode
± 2 kV common
mode
Mains power quality is that of a
typical commercial and/or hospital
environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
< 5 % UT
(> 95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
(> 95 % dip in UT)
< 5 % UT
(> 95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
(> 95 % dip in UT)
Mains power quality is that of a
typical commercial and/or hospital
environment. If the user of Sigma M
requires continued operation during
power mains interruptions, it is
recommended that Sigma M be
powered from an uninterruptible
power supply or a battery.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
are at levels characteristic of a
typical location in a typical
commercial and/or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Table 6.3 Electromagnetic immunity IEC 60601-1-2 Ed2
App
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39
6 Technical specifications
Sigma M is suitable for use in the specified electromagnetic environment. The purchaser or user
of Sigma M should assure that it is used in an electromagnetic environment as described below:
Immunity
Test
IEC
60601-1-2
Test Level
Compliance
Level
Electromagnetic
Environment
Portable and mobile RF communications equipment
are used no closer to any part of Sigma M, including
cables, than the recommended separation distance
calculated from the equation appropriate for the
frequency of the transmitter.
Recommended Separation Distance:
Conducted
RF IEC
61000-4-6
3 V150 kHz
to80 MHz
[ V1 ] 3 V
Radiated
RFIEC
61000-4-3
3 V/m80
MHz to2,5
GHz
[ E1 ] 3 V/m
d =[
3,5
] P
V1
d =[
3,5
] P
E1
d =[
E1
80 MHz to 800 MHz
] P
800 MHz to 2,5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).Field strengths from fixed RF
transmitters, as determined by an electromagnetic
site survey,* are less than the compliance level in
each frequency range.** Interference may occur in
the vicinity of equipment marked with the following
symbol:
*Field strengths from fixed transmitters, such as base stations for cellular telephones and land
mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be
estimated accurately. To assess the electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be performed. If the measured field strength exceeds the
RF compliance level above, observe Sigma M to verify normal operation in each use location. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating Sigma M.
**Over the frequency range 150 kHz to 80 MHz, field strengths are less than [V1] V/m.
The Recommended Separation Distances are listed on page 21.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
Table 6.4 RF immunity of non-life-support equipment or system IEC 60601-1-2
App
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200150 rev 3
7 Appendix 1, Sigma M products and accessories
7 Appendix 1, Sigma M products and
accessories
A Sigma M system (with the exception of the PC) is assembled using
the following parts:
Part no.
900003
900004
Products
Description
Sigma M sensor size 1 (Type S1):
– USB electronics with battery
– Sigma M charger
– Wall mount set
– USB-cable, 3m
– CliniView software CD
– Manuals
– Sensor ID sticker
– Mounting magnet
Sigma M sensor size 2 (Type S2):
– USB electronics with battery
– Sigma M charger
– Wall mount set
– USB-cable, 3m
– CliniView software CD
– Manuals
– Sensor ID sticker
– Mounting magnet
The following accessories are approved parts:
Part no.
55042
200382
200383
5169795
5169703
200245
200162
Accessories
Description
Sigma M hygienic covers (500 pcs)
Sigma M Charger, EUR
Sigma M Charger, USA
Rechargable Battery
Mounting Magnet
Wall Mount set
Sigma M Sensor holder starter kit Size 1
- Bitewing holder 1 pc
- Posterior holder (UR/LL) 1 pc
- Posterior holder (UL/LR) 1 pc
- Periapical holder (UR/LL) 1pc
- Periapical holder (UL/LR) 1 pc
- Endo holder (UR/LL) 1 pc
- Endo holder (UL/LR) 1 pc
- Positioning ring 1 pc
App
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41
7 Appendix 1, Sigma M products and accessories
Part no.
200163
200333
200335
200337
200338
200334
200339
200340
200330
200331
200332
Accessories
Description
Sigma M Sensor Holder Starter Kit Size 2
- Bitewing holder 1 pc
- Posterior holder (UR/LL) 1 pc
- Posterior holder (UL/LR) 1 pc
- Periapical holder (UR/LL) 1pc
- Periapical holder (UL/LR) 1 pc
- Endo holder (UR/LL) 1 pc
- Endo holder (UL/LR) 1 pc
- Positioning ring 1 pc
Bitewing Refill S1 Refill Pack, 10 pcs
Posterior S1 Refill pack, 10 pcs
Periapical S1 Refill Pack, 10 pcs
Endo S1 Refill Pack, 10 pcs
Positioning ring Refill Pack, 5 pcs
Bitewing S2 Refill Pack, 10 pcs
Posterior S2 Refill pack, 10 pcs
Super-Bite Senso Holders (KerrHawe)
- Super-Bite Senso Anterior 2 pcs
- Super-Bite Senso Posterior 2 pcs
Kwik-Bite Senso Holders (KerrHawe)
- Kwik-Bite Senso 4 pcs
Endo-Bite Senso Holders (KerrHawe)
- Endo-Bite Senso Anterior 2 pcs
- Endo-Bite Senso Posterior 2 pcs
App
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200150 rev 3
App
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Instrumentarium Dental reserves the right to make changes in specification and features shown herein, or discontinue the product described at any time without notice or obligation. Contact your
Instrumentarium Dental representative for the most current information.
Copyright © 04/2007 by PaloDEx Group Oy. All rights reserved.
Instrumentarium Dental
P.O.Box 20, FI-04301 Tuusula, Finland
Tel. +358 45 7882 2000
Fax +358 45 7882 2506
Americas:
Instrumentarium Dental Inc.
Milwaukee, Wisconsin, U.S.A.
Tel. 800 558 6120
Fax 414 481 8665
ro
Sigma M
App
User Manual, English
200150
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rev 3 Printed in Finland 04/2007

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