Instrumentarium Dental PaloDEx Group SM Digital Intraoral Sensor User Manual

Instrumentarium Dental, PaloDEx Group Oy Digital Intraoral Sensor

User manual

Sigma M User Manual200150   rev 3Sigma M User Manual200150   rev 3ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
Copyright Code: 200150   rev 3      Date: 26 April 2007Document code: D500616 rev 3Copyright © 04/2007 by PaloDEx Group Oy. All rightsreserved.Manufactured by Instrumentarium DentalNahkelantie 160 (P.O. Box 20)FI-04300 TuusulaFINLANDTel. +358 45 7882 2000Fax. +358 45 7882 2506Documentation, trademark and the software are copyrighted with allrights reserved. Under the copyright laws the documentation may notbe copied, photocopied, reproduced, translated, or reduced to anyelectronic medium or machine readable form in whole or part, withoutthe prior written permission of Instrumentarium Dental.The original language of this manual is English.Instrumentarium Dental reserves the right to make changes inspecification and features shown herein, or discontinue the productdescribed at any time without notice or obligation. Contact yourInstrumentarium Dental representative for the most currentinformation.For service, contact your local distributor.Copyright Code: 200150   rev 3      Date: 26 April 2007Document code: D500616 rev 3Copyright © 04/2007 by PaloDEx Group Oy. All rightsreserved.Manufactured by Instrumentarium DentalNahkelantie 160 (P.O. Box 20)FI-04300 TuusulaFINLANDTel. +358 45 7882 2000Fax. +358 45 7882 2506Documentation, trademark and the software are copyrighted with allrights reserved. Under the copyright laws the documentation may notbe copied, photocopied, reproduced, translated, or reduced to anyelectronic medium or machine readable form in whole or part, withoutthe prior written permission of Instrumentarium Dental.The original language of this manual is English.Instrumentarium Dental reserves the right to make changes inspecification and features shown herein, or discontinue the productdescribed at any time without notice or obligation. Contact yourInstrumentarium Dental representative for the most currentinformation.For service, contact your local distributor.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
200150  rev  3 Instrumentarium Dental iTable of Contents1 Sigma M system.......................................................................................11.1 Introduction ...........................................................................................................11.2 Main parts of the Sigma M device.........................................................................21.3 Accessories...........................................................................................................31.4 Battery...................................................................................................................52 Capturing intraoral images .....................................................................92.1 Before taking sensor into use................................................................................92.2 Indicators.............................................................................................................102.3 Capturing image with one sensor........................................................................112.4 Using two sizes of sensors..................................................................................132.5 Sharing sensor with other users..........................................................................152.6 Taking images with USB cable connected.......................................................... 172.7 Recharging the battery........................................................................................182.8 Recommended exposure times ..........................................................................193 Care instructions....................................................................................213.1 Cleaning the Sigma unit...................................................................................... 213.2 Handling the device.............................................................................................224 Trouble shooting....................................................................................234.1 Diagnosing image quality problems ....................................................................234.2 Diagnosing equipment specific problems............................................................245 General information...............................................................................275.1 Manufacturer’s liability.........................................................................................275.2 Markings and graphics symbols..........................................................................275.3 Main label............................................................................................................305.4 Manuals...............................................................................................................305.5 Disposal ..............................................................................................................305.6 Warnings.............................................................................................................315.7 Notice of wireless LAN usage ............................................................................. 315.8 FCC certification..................................................................................................326 Technical specifications........................................................................336.1 General ...............................................................................................................336.2 Dimensions ......................................................................................................... 336.4 RF exposure info.................................................................................................346.3 Sensor unit..........................................................................................................346.5 Ambient conditions..............................................................................................356.6 Image acquisition system requirements..............................................................356.7 Electromagnetic Compatibility (EMC) tables.......................................................367 Appendix 1, Sigma M products and accessories................................41200150  rev  3 Instrumentarium Dental iTable of Contents1 Sigma M system.......................................................................................11.1 Introduction ...........................................................................................................11.2 Main parts of the Sigma M device.........................................................................21.3 Accessories...........................................................................................................31.4 Battery...................................................................................................................52 Capturing intraoral images .....................................................................92.1 Before taking sensor into use................................................................................92.2 Indicators.............................................................................................................102.3 Capturing image with one sensor........................................................................112.4 Using two sizes of sensors..................................................................................132.5 Sharing sensor with other users..........................................................................152.6 Taking images with USB cable connected.......................................................... 172.7 Recharging the battery........................................................................................182.8 Recommended exposure times ..........................................................................193 Care instructions....................................................................................213.1 Cleaning the Sigma unit...................................................................................... 213.2 Handling the device.............................................................................................224 Trouble shooting....................................................................................234.1 Diagnosing image quality problems ....................................................................234.2 Diagnosing equipment specific problems............................................................245 General information...............................................................................275.1 Manufacturer’s liability.........................................................................................275.2 Markings and graphics symbols..........................................................................275.3 Main label............................................................................................................305.4 Manuals...............................................................................................................305.5 Disposal ..............................................................................................................305.6 Warnings.............................................................................................................315.7 Notice of wireless LAN usage ............................................................................. 315.8 FCC certification..................................................................................................326 Technical specifications........................................................................336.1 General ...............................................................................................................336.2 Dimensions ......................................................................................................... 336.4 RF exposure info.................................................................................................346.3 Sensor unit..........................................................................................................346.5 Ambient conditions..............................................................................................356.6 Image acquisition system requirements..............................................................356.7 Electromagnetic Compatibility (EMC) tables.......................................................367 Appendix 1, Sigma M products and accessories................................41ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
 ii Instrumentarium Dental 200150  rev 3 ii Instrumentarium Dental 200150  rev 3ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
1 Sigma M system200150  rev  3 Instrumentarium Dental 11 Sigma M system1.1 INTRODUCTIONThank you for purchasing Instrumentarium Dental Sigma M digitalintraoral sensor.The Sigma M sensor is intended for dental x-ray imaging. Sigma Mproduces high quality digital X-ray images of teeth and adjacentstructures instantly without the need for film or chemicals. It allows theuser to view, enhance, store, send and print images using theCliniView imaging software.Two sensor sizes are available for various dental X-ray imagingneeds.         Fig 1.1. 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 sensortype size 2 (S2) is to capture bitewing and horizontal periapicalimages. The sensor type is marked on the main label (see chapterMain label for details).The use of Sigma M system requires intraoral X-ray unit and acomputer with a wireless network (Wi-Fi/Wlan) connectivity. USB portcan 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 andconfigured to operate in a desired WLAN network. See Sigma Minstallation manual and this Sigma M user manual for instructions.The Sigma M sensor is battery operated. The device is supplied with arechargeable battery installed. Make sure that the battery is rechargedprior 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 ManualRead all the instructions carefully before the Sigma M use.Size 1:   1580 x 1050 pixelSize 2:  1916 x 1358 pixel1 Sigma M system200150  rev  3 Instrumentarium Dental 11 Sigma M system1.1 INTRODUCTIONThank you for purchasing Instrumentarium Dental Sigma M digitalintraoral sensor.The Sigma M sensor is intended for dental x-ray imaging. Sigma Mproduces high quality digital X-ray images of teeth and adjacentstructures instantly without the need for film or chemicals. It allows theuser to view, enhance, store, send and print images using theCliniView imaging software.Two sensor sizes are available for various dental X-ray imagingneeds.         Fig 1.1. 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 sensortype size 2 (S2) is to capture bitewing and horizontal periapicalimages. The sensor type is marked on the main label (see chapterMain label for details).The use of Sigma M system requires intraoral X-ray unit and acomputer with a wireless network (Wi-Fi/Wlan) connectivity. USB portcan 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 andconfigured to operate in a desired WLAN network. See Sigma Minstallation manual and this Sigma M user manual for instructions.The Sigma M sensor is battery operated. The device is supplied with arechargeable battery installed. Make sure that the battery is rechargedprior 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 ManualRead all the instructions carefully before the Sigma M use.Size 1:   1580 x 1050 pixelSize 2:  1916 x 1358 pixelApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
1 Sigma M system2 Instrumentarium Dental 200150  rev 31.2 MAIN PARTS OF THE SIGMA M DEVICEMagneticmountingguideMain labelCONNECTORS BATTERY COVER1 Sigma M system2 Instrumentarium Dental 200150  rev 31.2 MAIN PARTS OF THE SIGMA M DEVICEMagneticmountingguideMain labelCONNECTORS BATTERY COVERApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
1 Sigma M system200150  rev  3 Instrumentarium Dental 31.3 ACCESSORIESSigma M Charger• included in the sales package• available in various type forlocal mains voltage andapprovals. Consult the localdistributor for correct type, Ifspare part is needed.Magnet Mount• included in the sales package• the magnet place can bedecided by the user (see page 9)• can be used for mounting thedevice during the imagecapture procedure or duringstorage• adhesive tape included forattaching the mount on tubeheadWall mount set• included in the sales package• for storage when not usedand during battery charge• screws for wall mountingincludedWARNING!Do not place the magnet on thecover of PC and monitor, ornearby a pacemaker.USB cable• included in the sales packageWARNING!Use only USB cable delivered withthe device to ensure properoperation according tospecification.1 Sigma M system200150  rev  3 Instrumentarium Dental 31.3 ACCESSORIESSigma M Charger• included in the sales package• available in various type forlocal mains voltage andapprovals. Consult the localdistributor for correct type, Ifspare part is needed.Magnet Mount• included in the sales package• the magnet place can bedecided by the user (see page 9)• can be used for mounting thedevice during the imagecapture procedure or duringstorage• adhesive tape included forattaching the mount on tubeheadWall mount set• included in the sales package• for storage when not usedand during battery charge• screws for wall mountingincludedWARNING!Do not place the magnet on thecover of PC and monitor, ornearby a pacemaker.USB cable• included in the sales packageWARNING!Use only USB cable delivered withthe device to ensure properoperation according tospecification.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
1 Sigma M system4 Instrumentarium Dental 200150  rev 3SENSOR HOLDERSWhen taking intraoral images it is necessary to keep the sensorparallel to the tubehead. Correct positioning is assisted with the helpof KerrHawe or Sigma M sensor holders.The sensor must be covered with a hygienic cover every time it isused.  Only use hygienic covers similar to hygienic covers deliveredwith the Sigma M system by Instrumentarium Dental.NOTE!The covers are protected against touch but they are not sterile.Sigma M Sensor holders (optionally)• available separately• consult your local dealer fordetailsKerrHawe Sensor holders (optionally)• available separately• consult your local dealer fordetailsHygienic covers • available separately1 Sigma M system4 Instrumentarium Dental 200150  rev 3SENSOR HOLDERSWhen taking intraoral images it is necessary to keep the sensorparallel to the tubehead. Correct positioning is assisted with the helpof KerrHawe or Sigma M sensor holders.The sensor must be covered with a hygienic cover every time it isused.  Only use hygienic covers similar to hygienic covers deliveredwith the Sigma M system by Instrumentarium Dental.NOTE!The covers are protected against touch but they are not sterile.Sigma M Sensor holders (optionally)• available separately• consult your local dealer fordetailsKerrHawe Sensor holders (optionally)• available separately• consult your local dealer fordetailsHygienic covers • available separatelyApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
1 Sigma M system200150  rev  3 Instrumentarium Dental 5SENSOR CABLE PLACEMENTTo prevent the patient biting the sensor cable, lead the cablealongside the holder as instructed below:1.4 BATTERY• Sigma M Battery, Spare part number: 5169795WARNING!Replace the battery only with Instrumentarium Dental Sigma Mbattery, part no. 5169795. Charging with equipment other than theoriginal Sigma M charger may cause heat generation or cell leakage.Use of another battery may present a risk of fire or explosion. Seeinstructions for replacing the battery.                   CORRECT                  INCORRECT1 Sigma M system200150  rev  3 Instrumentarium Dental 5SENSOR CABLE PLACEMENTTo prevent the patient biting the sensor cable, lead the cablealongside the holder as instructed below:1.4 BATTERY• Sigma M Battery, Spare part number: 5169795WARNING!Replace the battery only with Instrumentarium Dental Sigma Mbattery, part no. 5169795. Charging with equipment other than theoriginal Sigma M charger may cause heat generation or cell leakage.Use of another battery may present a risk of fire or explosion. Seeinstructions for replacing the battery.                   CORRECT                  INCORRECTApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
1 Sigma M system6 Instrumentarium Dental 200150  rev 3CHECKING BATTERY STATUSThe remaining battery charge level is displayed in CliniView, next tothe 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 softwareinforms the user about low battery. Normal operation voltage is 3700-4200 mV.  Below 3500 mV the sensor does not turn on.REPLACING BATTERYIf battery operation has drastically decreased, a change of battery isrecommended.  Battery capacity will decrease over time.The battery should be replaced at intervals of 1-3 years or after 500recharge cycles. Replace only with original Sigma M battery (orderpart number 5169795). Opening the battery cover must be done sothat the cover does not get damaged.1 Switch off the Sigma M sensor and open the battery cover screw1 Sigma M system6 Instrumentarium Dental 200150  rev 3CHECKING BATTERY STATUSThe remaining battery charge level is displayed in CliniView, next tothe 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 softwareinforms the user about low battery. Normal operation voltage is 3700-4200 mV.  Below 3500 mV the sensor does not turn on.REPLACING BATTERYIf battery operation has drastically decreased, a change of battery isrecommended.  Battery capacity will decrease over time.The battery should be replaced at intervals of 1-3 years or after 500recharge cycles. Replace only with original Sigma M battery (orderpart number 5169795). Opening the battery cover must be done sothat the cover does not get damaged.1 Switch off the Sigma M sensor and open the battery cover screwApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
1 Sigma M system200150  rev  3 Instrumentarium Dental 7  2 Push the cover in the direction indicated by an arrow and removethe cover carefully. Make sure not to bend the cover whenremoving it. Disconnect the battery cable and dispose of thebattery properly.  3 Replace with a new battery. Do not shortcut the poles of thebattery, it may cause danger of explosion.CAUTION!The battery used in this device may present a fire or a chemical burnhazard if mistreated. Do not dissemble, heat to 100°C (212 F) orincinerate.NOTE!The battery is harmful to the environment and so it must be disposedof in accordance with local regulations.WARNING!The battery may explode if two poles are short-circuited.1 Sigma M system200150  rev  3 Instrumentarium Dental 7  2 Push the cover in the direction indicated by an arrow and removethe cover carefully. Make sure not to bend the cover whenremoving it. Disconnect the battery cable and dispose of thebattery properly.  3 Replace with a new battery. Do not shortcut the poles of thebattery, it may cause danger of explosion.CAUTION!The battery used in this device may present a fire or a chemical burnhazard if mistreated. Do not dissemble, heat to 100°C (212 F) orincinerate.NOTE!The battery is harmful to the environment and so it must be disposedof in accordance with local regulations.WARNING!The battery may explode if two poles are short-circuited.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
1 Sigma M system8 Instrumentarium Dental 200150  rev 31 Sigma M system8 Instrumentarium Dental 200150  rev 3ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 92 Capturing intraoral images2.1 BEFORE TAKING SENSOR INTO USERefer to chapter “Technical Specifications” and “Image AcquisitionSystem Requirements” for hardware requirement.1 Make sure the CliniView software (version 6.4.1 or later) hasbeen installed properly.2 Make sure the necessary WLAN equipments have been installedand WLAN network is working properly.3 Make sure Sigma M sensor(s) has been properly configured tooperate in the desired WLAN network. See CliniView installationmanual and Sigma M installation manual for details.4 The sensor unit is rechargeable battery operated. It is rechargedwith the included Sigma M charger. A daily recharge isrecommended. Approximately 200 exposures can be taken with afully recharged battery. Before using the sensor, make sure thebattery has been recharged. Connect the charger connector to the Sigma M charger. Thesensor cannot be used when recharging batteries.5 Disinfect the sensor and the cable before the patient work.NOTE!Use the magnet included in the sales package to mount the sensor onthe X-ray tube head for ergonomic and efficient workflow.NOTE!Ask your sensor dealer for holder offering designed for the Sigma Msensor.2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 92 Capturing intraoral images2.1 BEFORE TAKING SENSOR INTO USERefer to chapter “Technical Specifications” and “Image AcquisitionSystem Requirements” for hardware requirement.1 Make sure the CliniView software (version 6.4.1 or later) hasbeen installed properly.2 Make sure the necessary WLAN equipments have been installedand WLAN network is working properly.3 Make sure Sigma M sensor(s) has been properly configured tooperate in the desired WLAN network. See CliniView installationmanual and Sigma M installation manual for details.4 The sensor unit is rechargeable battery operated. It is rechargedwith the included Sigma M charger. A daily recharge isrecommended. Approximately 200 exposures can be taken with afully recharged battery. Before using the sensor, make sure thebattery has been recharged. Connect the charger connector to the Sigma M charger. Thesensor cannot be used when recharging batteries.5 Disinfect the sensor and the cable before the patient work.NOTE!Use the magnet included in the sales package to mount the sensor onthe X-ray tube head for ergonomic and efficient workflow.NOTE!Ask your sensor dealer for holder offering designed for the Sigma Msensor.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images10 Instrumentarium Dental 200150  rev 32.2 INDICATORSDevice status indicatorIndicator Device statusOrange Power onGreen Ready for image captureGreen blinking Image integrationOrange blinking Image transmissionBattery status indicatorIndicator Battery statusOrange blinking Low battery (a few images can still be captured to complete the patient)Orange blinking fast Critically low battery (image capturing not recommended)Orange Battery chargingOff Charge complete, battery is OK2 Capturing intraoral images10 Instrumentarium Dental 200150  rev 32.2 INDICATORSDevice status indicatorIndicator Device statusOrange Power onGreen Ready for image captureGreen blinking Image integrationOrange blinking Image transmissionBattery status indicatorIndicator Battery statusOrange blinking Low battery (a few images can still be captured to complete the patient)Orange blinking fast Critically low battery (image capturing not recommended)Orange Battery chargingOff Charge complete, battery is OKApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 112.3 CAPTURING IMAGE WITH ONE SENSORIt is assumed here that one, either size 1 or size 2 sensor, is selectedfrom the Installed device -menu on the CliniView software. It is alsoassumed that this sensor is selected as a default sensor device usingthe Tools-Intra-Sigma M settings -menu of the CliniView software. Seethe Sigma M installation manual for details.1 Start CliniView software and select a patient.2 Switch on the sensor by pressing the sensor power switch.NOTE!For efficient work flow the sensor and Cliniview capture mode can beturned on well before inserting the sensor into the patient's mouth.Consequently the system will be immediately ready for capture whenthe sensor is in place. If you forget to power the sensor at thebeginning of the workflow you can do it also later before the imagecapture.3 Protect the sensor with a hygienic cover and place the sensor onto the holder.• Hold the hygienic cover with the paper side pointing downwards.• Carefully insert the sensor between the white tab and the basepaper.• Peel away the upper transparent protective foil completely.• Peel away the base paper completely from the underside.4 Start image capturing in Cliniview by pressing the Start intraoralimage capturing  -button.NOTE!The exposure must be made within 15 minutes maximum after clickingthe “Start intraoral image capturing” button, depending on the time-outsetting in the CliniView software. As well as the CliniView time-outsetting, the sensor also has a power off timer.NOTE!The other image capture icon can be used for capturing image usingthe template if several image are taken in series.5 Position the sensor in the patient´s mouth. The sensor unit can beeither on the patient's chest or with the magnetic mounting on theside of the X-ray unit tube head. Position the Intraoral X-ray unitas appropriate.POWER   SWITCH2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 112.3 CAPTURING IMAGE WITH ONE SENSORIt is assumed here that one, either size 1 or size 2 sensor, is selectedfrom the Installed device -menu on the CliniView software. It is alsoassumed that this sensor is selected as a default sensor device usingthe Tools-Intra-Sigma M settings -menu of the CliniView software. Seethe Sigma M installation manual for details.1 Start CliniView software and select a patient.2 Switch on the sensor by pressing the sensor power switch.NOTE!For efficient work flow the sensor and Cliniview capture mode can beturned on well before inserting the sensor into the patient's mouth.Consequently the system will be immediately ready for capture whenthe sensor is in place. If you forget to power the sensor at thebeginning of the workflow you can do it also later before the imagecapture.3 Protect the sensor with a hygienic cover and place the sensor onto the holder.• Hold the hygienic cover with the paper side pointing downwards.• Carefully insert the sensor between the white tab and the basepaper.• Peel away the upper transparent protective foil completely.• Peel away the base paper completely from the underside.4 Start image capturing in Cliniview by pressing the Start intraoralimage capturing  -button.NOTE!The exposure must be made within 15 minutes maximum after clickingthe “Start intraoral image capturing” button, depending on the time-outsetting in the CliniView software. As well as the CliniView time-outsetting, the sensor also has a power off timer.NOTE!The other image capture icon can be used for capturing image usingthe template if several image are taken in series.5 Position the sensor in the patient´s mouth. The sensor unit can beeither on the patient's chest or with the magnetic mounting on theside of the X-ray unit tube head. Position the Intraoral X-ray unitas appropriate.POWER   SWITCHApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images12 Instrumentarium Dental 200150  rev 3NOTE!Make sure that the device status indicator illumates green beforemaking the exposure.6 Make the exposure by pressing the exposure button of the x-rayunit. Blinking status indicator on the device indicates imagetransfer.NOTE!If several images are captured in series, do not switch the sensor offbetween the exposures. The auto power off will turn the sensor off, ifthe sensor is not used approximately in 10 minutes.7 After the image capturing click Abort image capturing button inCliniView.1 When capturing is finished switch the sensor off, removedisposable covers and disinfect the sensor if necessary.WARNING!During the exposure cycle radiation the control protection guidelinesmust be observed.WARNING!Minimize the number of running programs before image capturing toensure the necessary operating system resources for the process.2 Capturing intraoral images12 Instrumentarium Dental 200150  rev 3NOTE!Make sure that the device status indicator illumates green beforemaking the exposure.6 Make the exposure by pressing the exposure button of the x-rayunit. Blinking status indicator on the device indicates imagetransfer.NOTE!If several images are captured in series, do not switch the sensor offbetween the exposures. The auto power off will turn the sensor off, ifthe sensor is not used approximately in 10 minutes.7 After the image capturing click Abort image capturing button inCliniView.1 When capturing is finished switch the sensor off, removedisposable covers and disinfect the sensor if necessary.WARNING!During the exposure cycle radiation the control protection guidelinesmust be observed.WARNING!Minimize the number of running programs before image capturing toensure the necessary operating system resources for the process.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 132.4 USING TWO SIZES OF SENSORSIt is assumed here that both sensor size 1 and sensor size 2 havebeen installed and enabled from the installed device -menu on theCliniview software. It is also assumed that the appropriate sensordevice has been configured as the default sensor device using theTools - Intra-Sigma M settings -menu of the Cliniview software. Seethe Sigma M installation manual for details.When both sensor sizes are installed, image capturing icons for bothsize 1 and size 2 sensors are displayed in the CliniView software. Theimage 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 previouschapter, with either of the sensors installed in the system. It is alsopossible to use both size 1 and size 2 sensor during one imagecapture session.NOTE!Both sensors can be activated simultaneously by clicking imagecapture icon of both sensor before exposure. The sensor that receivex-ray sends the image to CliniView. The other sensor remains readyfor exposure.If two sensors are activated simultaneously, there will be two sensorstatus bars on the PC screen.1 Start CliniView software and select a patient.2 Switch on the sensors to be used by pressing the sensor powerswitch.3 Protect the sensor with a hygienic cover and place the sensor tothe holder.4 Start image capturing in Cliniview by pressing the Start intraoralimage capturing  -button.5 Position the sensor in the patient´s mouth. The sensor unit can beeither on patient’s chest or with the magnetic mounting on theside of the x-ray unit tube head. Position the Intraoral x-ray unit asappropriate.POWER   SWITCH2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 132.4 USING TWO SIZES OF SENSORSIt is assumed here that both sensor size 1 and sensor size 2 havebeen installed and enabled from the installed device -menu on theCliniview software. It is also assumed that the appropriate sensordevice has been configured as the default sensor device using theTools - Intra-Sigma M settings -menu of the Cliniview software. Seethe Sigma M installation manual for details.When both sensor sizes are installed, image capturing icons for bothsize 1 and size 2 sensors are displayed in the CliniView software. Theimage 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 previouschapter, with either of the sensors installed in the system. It is alsopossible to use both size 1 and size 2 sensor during one imagecapture session.NOTE!Both sensors can be activated simultaneously by clicking imagecapture icon of both sensor before exposure. The sensor that receivex-ray sends the image to CliniView. The other sensor remains readyfor exposure.If two sensors are activated simultaneously, there will be two sensorstatus bars on the PC screen.1 Start CliniView software and select a patient.2 Switch on the sensors to be used by pressing the sensor powerswitch.3 Protect the sensor with a hygienic cover and place the sensor tothe holder.4 Start image capturing in Cliniview by pressing the Start intraoralimage capturing  -button.5 Position the sensor in the patient´s mouth. The sensor unit can beeither on patient’s chest or with the magnetic mounting on theside of the x-ray unit tube head. Position the Intraoral x-ray unit asappropriate.POWER   SWITCHApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images14 Instrumentarium Dental 200150  rev 3NOTE!Make sure that the sensor, which is intended to use ispowered on and ready for image capture beforeexposure. Status indicator illuminates green when thesensor is ready.6 Make the exposure by pressing the exposure button of the x-rayunit. Blinking status indicator on the device indicates imagetransfer.NOTE!If several images are captured in series, do not switch the sensor offbetween the exposures. The auto power off will turn the sensor off, ifthe sensor is not used approximately in 10 minutes.7 After the image capturing click Abort image capturing button inCliniView.8 When capturing is finished switch the sensor off, removedisposable covers and disinfect the sensor if necessary.WARNING!During the exposure cycle radiation the control protection guidelinesmust be observed.WARNING!Minimize the number of running programs before image capturing toensure the necessary operating system resources for the process.2 Capturing intraoral images14 Instrumentarium Dental 200150  rev 3NOTE!Make sure that the sensor, which is intended to use ispowered on and ready for image capture beforeexposure. Status indicator illuminates green when thesensor is ready.6 Make the exposure by pressing the exposure button of the x-rayunit. Blinking status indicator on the device indicates imagetransfer.NOTE!If several images are captured in series, do not switch the sensor offbetween the exposures. The auto power off will turn the sensor off, ifthe sensor is not used approximately in 10 minutes.7 After the image capturing click Abort image capturing button inCliniView.8 When capturing is finished switch the sensor off, removedisposable covers and disinfect the sensor if necessary.WARNING!During the exposure cycle radiation the control protection guidelinesmust be observed.WARNING!Minimize the number of running programs before image capturing toensure the necessary operating system resources for the process.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 152.5 SHARING SENSOR WITH OTHER USERSIt is assumed here that two or more workstations in different roomshave been configured to operate in the same Sigma M network. It is possible to use default sensor assignment for each room oralternatively select the sensor to be used from a list of availablesensors in each image capture session. Select "Use preselectedsensors" from Tools - Intra - Sigma M settings -menu to use defaultsensor assignment. See Sigma installation manual and user manualfor details.NOTE!Several rooms can select one shared sensor as their default sensordevice. The sensor allows only one user at a time. If the sensor hasbeen previously used by someone else, the user is asked to confirmselection when activated to avoid unintentional connection to thesensor. 1 Start CliniView software and select a patient.2 Switch on the sensors to be used by pressing the sensor powerswitch.3 Protect the sensor with a hygienic cover and place the sensor onto the holder.4 Start image capturing in CliniView by pressingthe  Start intraoral image capturing button ofthe appropriate sensor.5 If default sensor assignment -mode is not used,select the desired sensor from the Select device dialogue thatopens. If the sensor has been transferred from one room toanother, the user will be notified that the sensor was previouslyassigned to another workstation.6 Position the sensor in the patient´s mouth. The sensor unit can beeither on patient’s chest or with the magnetic mounting on theside of the x-ray unit tube head. Position the Intraoral x-ray unit asappropriate.POWER   SWITCH2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 152.5 SHARING SENSOR WITH OTHER USERSIt is assumed here that two or more workstations in different roomshave been configured to operate in the same Sigma M network. It is possible to use default sensor assignment for each room oralternatively select the sensor to be used from a list of availablesensors in each image capture session. Select "Use preselectedsensors" from Tools - Intra - Sigma M settings -menu to use defaultsensor assignment. See Sigma installation manual and user manualfor details.NOTE!Several rooms can select one shared sensor as their default sensordevice. The sensor allows only one user at a time. If the sensor hasbeen previously used by someone else, the user is asked to confirmselection when activated to avoid unintentional connection to thesensor. 1 Start CliniView software and select a patient.2 Switch on the sensors to be used by pressing the sensor powerswitch.3 Protect the sensor with a hygienic cover and place the sensor onto the holder.4 Start image capturing in CliniView by pressingthe  Start intraoral image capturing button ofthe appropriate sensor.5 If default sensor assignment -mode is not used,select the desired sensor from the Select device dialogue thatopens. If the sensor has been transferred from one room toanother, the user will be notified that the sensor was previouslyassigned to another workstation.6 Position the sensor in the patient´s mouth. The sensor unit can beeither on patient’s chest or with the magnetic mounting on theside of the x-ray unit tube head. Position the Intraoral x-ray unit asappropriate.POWER   SWITCHApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images16 Instrumentarium Dental 200150  rev 3NOTE!Make sure that the device status indicator illuminatesgreen before making the exposure.7 Make the exposure by pressing the exposure button of the x-rayunit. Blinking status indicator on the device indicates imagetransfer.NOTE!If several images are captured in series, do not switch the sensor offbetween the exposures. The auto power off will turn the sensor off, ifthe sensor is not used approximately in 10 minutes.8 After the image capturing click Abort image capturing button inCliniView.9 When capturing is finished switch the sensor off, removedisposable covers and disinfect the sensor if necessary.WARNING!During the exposure cycle radiation the control protection guidelinesmust be observed.WARNING!Minimize the number of running programs before image capturing toensure the necessary operating system resources for the process.2 Capturing intraoral images16 Instrumentarium Dental 200150  rev 3NOTE!Make sure that the device status indicator illuminatesgreen before making the exposure.7 Make the exposure by pressing the exposure button of the x-rayunit. Blinking status indicator on the device indicates imagetransfer.NOTE!If several images are captured in series, do not switch the sensor offbetween the exposures. The auto power off will turn the sensor off, ifthe sensor is not used approximately in 10 minutes.8 After the image capturing click Abort image capturing button inCliniView.9 When capturing is finished switch the sensor off, removedisposable covers and disinfect the sensor if necessary.WARNING!During the exposure cycle radiation the control protection guidelinesmust be observed.WARNING!Minimize the number of running programs before image capturing toensure the necessary operating system resources for the process.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 172.6 TAKING IMAGES WITH USB CABLE CONNECTEDNOTE!The Windows XP operating system will open a Windows Explorerdialogue when Sigma M is connected via USB. Close this window.1 Start CliniView software and select a patient2 Switch on the sensor by pressing the sensor power switch.3 Protect the sensor with a hygienic cover and place the sensor onto the holder.4 Start image capturing in CliniView by pressingthe Start intraoral image capturing button.5 Position the sensor in the patient´s mouth. Thesensor unit can be either on patient’s chest orwith the magnetic mounting on the side of the x-ray unit tubehead. Position the Intraoral x-ray unit as appropriate.NOTE!Make sure that the device status indicator illuminatesgreen before making the exposure.6 Make the exposure by pressing the exposure button of the x-rayunit. Blinking status indicator on the device indicates imagetransfer.NOTE!If several images are captured in series, do not switch the sensor offbetween the exposures. The auto power off will turn the sensor off, ifthe sensor is not used approximately in 10 minutes.7 After the image capturing click Abort image capturing button inCliniView.POWER   SWITCH2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 172.6 TAKING IMAGES WITH USB CABLE CONNECTEDNOTE!The Windows XP operating system will open a Windows Explorerdialogue when Sigma M is connected via USB. Close this window.1 Start CliniView software and select a patient2 Switch on the sensor by pressing the sensor power switch.3 Protect the sensor with a hygienic cover and place the sensor onto the holder.4 Start image capturing in CliniView by pressingthe Start intraoral image capturing button.5 Position the sensor in the patient´s mouth. Thesensor unit can be either on patient’s chest orwith the magnetic mounting on the side of the x-ray unit tubehead. Position the Intraoral x-ray unit as appropriate.NOTE!Make sure that the device status indicator illuminatesgreen before making the exposure.6 Make the exposure by pressing the exposure button of the x-rayunit. Blinking status indicator on the device indicates imagetransfer.NOTE!If several images are captured in series, do not switch the sensor offbetween the exposures. The auto power off will turn the sensor off, ifthe sensor is not used approximately in 10 minutes.7 After the image capturing click Abort image capturing button inCliniView.POWER   SWITCHApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images18 Instrumentarium Dental 200150  rev 38 When capturing is finished switch the sensor off, removedisposable covers and disinfect the sensor if necessary.WARNING!During the exposure cycle radiation the control protection guidelinesmust be observed.WARNING!Minimize the number of running programs before image capturing toensure the necessary operating system resources for the process.9 Before unplugging the USB cable, click the “Unplug or ejecthardware” icon on the desktop. Choose Sigma M and then clickOK. “Safely remove hardware” icon on the toolbar, Sigma M = X-ray device.2.7 RECHARGING THE BATTERYThe battery is recharged with the charger supplied with the device. More than 200 image captures can be made with a fully charged freshbattery. Low battery status is indicated with a flashing orange LED. Afew images can still be taken to complete the patient until the orangeLED starts flashing fast. Fast flashing indicates critically low batteryand image capturing is no more recommended.Charge the empty battery by first plugging the charger cable in to thesensor unit, and then plugging in to the mains. Charging takes about 2hours and it is indicated with an orange LED that switches off whencharging is complete. The device cannot be used when the charger is connected.WARNING!Charging with equipment other than the original Sigma M charger maycause heat generation or cell leakage.2 Capturing intraoral images18 Instrumentarium Dental 200150  rev 38 When capturing is finished switch the sensor off, removedisposable covers and disinfect the sensor if necessary.WARNING!During the exposure cycle radiation the control protection guidelinesmust be observed.WARNING!Minimize the number of running programs before image capturing toensure the necessary operating system resources for the process.9 Before unplugging the USB cable, click the “Unplug or ejecthardware” icon on the desktop. Choose Sigma M and then clickOK. “Safely remove hardware” icon on the toolbar, Sigma M = X-ray device.2.7 RECHARGING THE BATTERYThe battery is recharged with the charger supplied with the device. More than 200 image captures can be made with a fully charged freshbattery. Low battery status is indicated with a flashing orange LED. Afew images can still be taken to complete the patient until the orangeLED starts flashing fast. Fast flashing indicates critically low batteryand image capturing is no more recommended.Charge the empty battery by first plugging the charger cable in to thesensor unit, and then plugging in to the mains. Charging takes about 2hours and it is indicated with an orange LED that switches off whencharging is complete. The device cannot be used when the charger is connected.WARNING!Charging with equipment other than the original Sigma M charger maycause heat generation or cell leakage.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images200150  rev  3 Instrumentarium Dental 192.8 RECOMMENDED EXPOSURE TIMESThe table below provides guidelines for exposure times for an averageDC generator at 70 kV and 7 mA. These values might need to beadjusted for specific generator characteristics (kV, mA).NOTE!The selected time varies as the square of the distance. The doseshould be increased if the distance from the sensor to the  focal spotincreases.70 kV Adult Adult Child ChildSSD 9” 12” 9” 12”Maxillary Incisor 0,100 0,200 0,050 0,100Maxillary Cuspid 0,100 0,200 0,050 0,100Maxillary Molar 0,160 0,320 0,080 0,160Mandibular Incisor 0,100 0,200 0,050 0,100Mandibular Cuspid 0,100 0,200 0,050 0,100Mandibular Molar 0,125 0,250 0,063 0,125Bitewing 0,125 0,250 0,063 0,1252 Capturing intraoral images200150  rev  3 Instrumentarium Dental 192.8 RECOMMENDED EXPOSURE TIMESThe table below provides guidelines for exposure times for an averageDC generator at 70 kV and 7 mA. These values might need to beadjusted for specific generator characteristics (kV, mA).NOTE!The selected time varies as the square of the distance. The doseshould be increased if the distance from the sensor to the  focal spotincreases.70 kV Adult Adult Child ChildSSD 9” 12” 9” 12”Maxillary Incisor 0,100 0,200 0,050 0,100Maxillary Cuspid 0,100 0,200 0,050 0,100Maxillary Molar 0,160 0,320 0,080 0,160Mandibular Incisor 0,100 0,200 0,050 0,100Mandibular Cuspid 0,100 0,200 0,050 0,100Mandibular Molar 0,125 0,250 0,063 0,125Bitewing 0,125 0,250 0,063 0,125ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
2 Capturing intraoral images20 Instrumentarium Dental 200150  rev 32 Capturing intraoral images20 Instrumentarium Dental 200150  rev 3ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
3 Care instructions200150  rev  3 Instrumentarium Dental 213 Care instructionsThe 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 defectNOTE!The sensor unit must not be opened or repaired by the user. There areno user serviceable parts in the equipment. In case of malfunctionalways contact your dealer.3.1 CLEANING THE SIGMA UNITThe Sigma M sensor unit contains sophisticated electronics. Treat thedevice 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 followthe instructions of the cleaning agent.Use a new disposable hygienic cover for every sensor usage. Ifrequired the sensor can be immersed in disinfectant solution. Followthe disinfectant instructions carefully. However immersion should notexceed 12 hours. Be carefull not to let any disinfectant to enter thesensor unit.Do not use aggressive chemicals that may damage the sensor (i.e.hypochlorite or other bleaching chemicals). As a guideline the sensorswithstand 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 instruments3 Care instructions200150  rev  3 Instrumentarium Dental 213 Care instructionsThe 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 defectNOTE!The sensor unit must not be opened or repaired by the user. There areno user serviceable parts in the equipment. In case of malfunctionalways contact your dealer.3.1 CLEANING THE SIGMA UNITThe Sigma M sensor unit contains sophisticated electronics. Treat thedevice 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 followthe instructions of the cleaning agent.Use a new disposable hygienic cover for every sensor usage. Ifrequired the sensor can be immersed in disinfectant solution. Followthe disinfectant instructions carefully. However immersion should notexceed 12 hours. Be carefull not to let any disinfectant to enter thesensor unit.Do not use aggressive chemicals that may damage the sensor (i.e.hypochlorite or other bleaching chemicals). As a guideline the sensorswithstand 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 instrumentsApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
3 Care instructions22 Instrumentarium Dental 200150  rev 33.2 HANDLING THE DEVICEWARNING!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 toelectrostatic 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 inuse3 Care instructions22 Instrumentarium Dental 200150  rev 33.2 HANDLING THE DEVICEWARNING!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 toelectrostatic 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 inuseApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
4 Trouble shooting200150  rev  3 Instrumentarium Dental 234 Trouble shooting4.1 DIAGNOSING IMAGE QUALITY PROBLEMSHigh quality images with sharp contrast and fine details give optimumdiagnostic information. Images of lesser quality are usually a result ofone 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 POSSIBLE CAUSE REMEDYImages are too grainy and light 1 Exposure factors (kV, mA, s) used are too low2 Image adjustments have not been performed3 Incorrect integration time or generator type (AC/DC)1 Increase exposure factors (see ch 2.8 recommended exposure times)2 Adjust the image brightness, contrast and gamma using CliniView software3 Set the generator type and the integration time for AC generator in CliniViewImages are too dark 1 Exposure factors used are too high2 Image adjustments have not been performed1 Decrease exposure factors2 Adjust the image brightness, contrast and gamma using CliniView softwareLack of image contrast 1 Image adjustments have not been performed2 Exposure factors (kV, mA, s) used are not optimal1 Adjust the image contrast using CliniView software2 Increase exposure factors (see ch 2.8 recommended exposure times)4 Trouble shooting200150  rev  3 Instrumentarium Dental 234 Trouble shooting4.1 DIAGNOSING IMAGE QUALITY PROBLEMSHigh quality images with sharp contrast and fine details give optimumdiagnostic information. Images of lesser quality are usually a result ofone 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 POSSIBLE CAUSE REMEDYImages are too grainy and light 1 Exposure factors (kV, mA, s) used are too low2 Image adjustments have not been performed3 Incorrect integration time or generator type (AC/DC)1 Increase exposure factors (see ch 2.8 recommended exposure times)2 Adjust the image brightness, contrast and gamma using CliniView software3 Set the generator type and the integration time for AC generator in CliniViewImages are too dark 1 Exposure factors used are too high2 Image adjustments have not been performed1 Decrease exposure factors2 Adjust the image brightness, contrast and gamma using CliniView softwareLack of image contrast 1 Image adjustments have not been performed2 Exposure factors (kV, mA, s) used are not optimal1 Adjust the image contrast using CliniView software2 Increase exposure factors (see ch 2.8 recommended exposure times)ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
4 Trouble shooting24 Instrumentarium Dental 200150  rev 34.2 DIAGNOSING EQUIPMENT SPECIFIC PROBLEMSImages are blurred 1 The patient moved2 The X-ray source moved3Incorrect integration time1 Prevent patient movement2 Prevent X-ray unit movement or have the unit serviced3 Set the integration time in CliniView to be longer than the exposure timeImages are burned out 1 Excessive exposure time 1 Set shorter exposure time 2 Change a long cone on the X-ray unitPROBLEM POSSIBLE CAUSE REMEDYSensor cannot be powered 1 The battery is empty2 The battery is not inside the electronics1 Recharge the battery2 Insert the batteryImage capturing icons are missing 1 Sigma M is not selected as an “installed device” in CliniView2 The patient is not selected in CliniView1 Select Sigma M as an installed device from Tools menu in CliniView2 Select the patientPROBLEM POSSIBLE CAUSE REMEDY4 Trouble shooting24 Instrumentarium Dental 200150  rev 34.2 DIAGNOSING EQUIPMENT SPECIFIC PROBLEMSImages are blurred 1 The patient moved2 The X-ray source moved3Incorrect integration time1 Prevent patient movement2 Prevent X-ray unit movement or have the unit serviced3 Set the integration time in CliniView to be longer than the exposure timeImages are burned out 1 Excessive exposure time 1 Set shorter exposure time 2 Change a long cone on the X-ray unitPROBLEM POSSIBLE CAUSE REMEDYSensor cannot be powered 1 The battery is empty2 The battery is not inside the electronics1 Recharge the battery2 Insert the batteryImage capturing icons are missing 1 Sigma M is not selected as an “installed device” in CliniView2 The patient is not selected in CliniView1 Select Sigma M as an installed device from Tools menu in CliniView2 Select the patientPROBLEM POSSIBLE CAUSE REMEDYApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
4 Trouble shooting200150  rev  3 Instrumentarium Dental 25Image capturing cannot be started 1 The battery is empty (The battery status indicator is blinking)2 The sensor is not powered3 The wireless network is not available4 The gainfile is not installed5 Used sensor is not set as default1 Recharge the battery2 Power up the sensor3 Refer to installation manual or contact IT support4 Use Gain Installer to install the gainfile5 Set the used sensor as a default in Tools menu in  CliniViewCliniView cannot find the sensor / Sensor is not ready for the image capturing1 Sigma M is off2 Wrong sensor switched on3 WLAN network not set up4 Another WLAN network is in use5 WLAN network is down because:– Access pointnot connected– Access pointnot powered– LAN cable notconnected6 WLAN settings are incorrect7 Charger is connected1 Switch on the sensor2 Switch on the sensor assigned to the workstation3 Set up the wireless network according to the installation manual4 Choose a WLAN network used for Sigma M5 Connect USB dongle, Power access point, Connect LAN cableMore informationfrom networkadministrator oradapter manuafacturer6 Check SSID, IP address and encryption7 Disconnect the chargerPROBLEM POSSIBLE CAUSE REMEDY4 Trouble shooting200150  rev  3 Instrumentarium Dental 25Image capturing cannot be started 1 The battery is empty (The battery status indicator is blinking)2 The sensor is not powered3 The wireless network is not available4 The gainfile is not installed5 Used sensor is not set as default1 Recharge the battery2 Power up the sensor3 Refer to installation manual or contact IT support4 Use Gain Installer to install the gainfile5 Set the used sensor as a default in Tools menu in  CliniViewCliniView cannot find the sensor / Sensor is not ready for the image capturing1 Sigma M is off2 Wrong sensor switched on3 WLAN network not set up4 Another WLAN network is in use5 WLAN network is down because:– Access pointnot connected– Access pointnot powered– LAN cable notconnected6 WLAN settings are incorrect7 Charger is connected1 Switch on the sensor2 Switch on the sensor assigned to the workstation3 Set up the wireless network according to the installation manual4 Choose a WLAN network used for Sigma M5 Connect USB dongle, Power access point, Connect LAN cableMore informationfrom networkadministrator oradapter manuafacturer6 Check SSID, IP address and encryption7 Disconnect the chargerPROBLEM POSSIBLE CAUSE REMEDYApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
4 Trouble shooting26 Instrumentarium Dental 200150  rev 3Charging the battery  does not start / red battery status indicator illuminates1 Wrong charger used2 Charger not plugged to the mains1 Use only the charger accompanied with a sensor2 Plug the charger to the mainsImage capturing icon cannot be activated1 Patient not selected2 Sigma M not selected in CV installed devices list3 Sensor is not preselected4 Gain file not installed1 Select the patient2 Select the correct Sigma M sensor type in CV installed devices list3 Click Select sensor and assign the sensor4 Install gain fileImage capturing fails (image transfer does not start after the exposure)1 Unactivated sensor has been exposed1 Retake an image with an activated sensorImage 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 CliniViewWARNINGDo not shut off thesensor. Do notconnect USB cable.2 Reset the Access PointPROBLEM POSSIBLE CAUSE REMEDY4 Trouble shooting26 Instrumentarium Dental 200150  rev 3Charging the battery  does not start / red battery status indicator illuminates1 Wrong charger used2 Charger not plugged to the mains1 Use only the charger accompanied with a sensor2 Plug the charger to the mainsImage capturing icon cannot be activated1 Patient not selected2 Sigma M not selected in CV installed devices list3 Sensor is not preselected4 Gain file not installed1 Select the patient2 Select the correct Sigma M sensor type in CV installed devices list3 Click Select sensor and assign the sensor4 Install gain fileImage capturing fails (image transfer does not start after the exposure)1 Unactivated sensor has been exposed1 Retake an image with an activated sensorImage 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 CliniViewWARNINGDo not shut off thesensor. Do notconnect USB cable.2 Reset the Access PointPROBLEM POSSIBLE CAUSE REMEDYApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
5 General information200150  rev  3 Instrumentarium Dental 275 General information5.1 MANUFACTURER’S LIABILITYWhen installing the Sigma M system it is important to observe allwarnings and precautions described in this manual. As a manufacturerwe can only assume liability for safe and reliable operation of theSigma M system when:• PC installation was performed according to manuals suppliedwith the PC• CliniView PC software is installed and used according to theInstallation & User Manual for CliniView Software.• Sigma M system is installed and used according to theInstallation & User Manual for Sigma M system• Maintenance and repairs are performed by a qualified Sigma MDealer and • Original or authorized replacement parts are used.If service on the equipment is performed, a work order describing thetype and extent of repair must be provided by the service technician.This must contain information of changes of nominal data or workrange performed. The work order must furthermore indicate the dateof 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, pleaserefer to troubleshooting in the user manual.Please find the electromagnetic compatibility tables according to IEC60601-1-1-2 Ed 2 in this Sigma M user manual.Use only USB cable delivered with the device to ensure properoperation according to specification.5.2 MARKINGS AND GRAPHICS SYMBOLSThe 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 mayoccur.5 General information200150  rev  3 Instrumentarium Dental 275 General information5.1 MANUFACTURER’S LIABILITYWhen installing the Sigma M system it is important to observe allwarnings and precautions described in this manual. As a manufacturerwe can only assume liability for safe and reliable operation of theSigma M system when:• PC installation was performed according to manuals suppliedwith the PC• CliniView PC software is installed and used according to theInstallation & User Manual for CliniView Software.• Sigma M system is installed and used according to theInstallation & User Manual for Sigma M system• Maintenance and repairs are performed by a qualified Sigma MDealer and • Original or authorized replacement parts are used.If service on the equipment is performed, a work order describing thetype and extent of repair must be provided by the service technician.This must contain information of changes of nominal data or workrange performed. The work order must furthermore indicate the dateof 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, pleaserefer to troubleshooting in the user manual.Please find the electromagnetic compatibility tables according to IEC60601-1-1-2 Ed 2 in this Sigma M user manual.Use only USB cable delivered with the device to ensure properoperation according to specification.5.2 MARKINGS AND GRAPHICS SYMBOLSThe 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 mayoccur.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
5 General information28 Instrumentarium Dental 200150  rev 3WARNING!Contains warnings and instructions about the safety of the unit. Ifthese warnings are not respected, serious risks and injury may becaused to the patient and operator.The following symbols are used in the Sigma M device and in themanuals:The instructions in this manual contain essential informationnecessary for the installation and use of the Sigma M system. Asmanufacturer we strongly recommend that you read this manualbefore installation and use.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 connectionDC connectorIndoor, dry location use onlyPowerNon-ionizing radiationThe 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.5 General information28 Instrumentarium Dental 200150  rev 3WARNING!Contains warnings and instructions about the safety of the unit. Ifthese warnings are not respected, serious risks and injury may becaused to the patient and operator.The following symbols are used in the Sigma M device and in themanuals:The instructions in this manual contain essential informationnecessary for the installation and use of the Sigma M system. Asmanufacturer we strongly recommend that you read this manualbefore installation and use.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 connectionDC connectorIndoor, dry location use onlyPowerNon-ionizing radiationThe 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.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
5 General information200150  rev  3 Instrumentarium Dental 29The following abbreviations may be used in this manual:PC Personal computerHD Hard diskHz Herz; cycles per secondMHz Millions of hertzCPU Central processing unit (computer)RAM Random access memoryMB Mega bytesGB Giga bytesCD-R Compact disc (recordable)CD-RW Compact disc (re-writable)DVD-RW Digital Versatile Disc (re-writable)HDD High density drivePCI Peripheral Component InterconnectLAN Local Area NetworkUSB Universal Serial BusMAC Medium Access ControlWLAN Wireless local area networkWi-Fi Wireless network compliant with IEEE802.115 General information200150  rev  3 Instrumentarium Dental 29The following abbreviations may be used in this manual:PC Personal computerHD Hard diskHz Herz; cycles per secondMHz Millions of hertzCPU Central processing unit (computer)RAM Random access memoryMB Mega bytesGB Giga bytesCD-R Compact disc (recordable)CD-RW Compact disc (re-writable)DVD-RW Digital Versatile Disc (re-writable)HDD High density drivePCI Peripheral Component InterconnectLAN Local Area NetworkUSB Universal Serial BusMAC Medium Access ControlWLAN Wireless local area networkWi-Fi Wireless network compliant with IEEE802.11ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
5 General information30 Instrumentarium Dental 200150  rev 35.3 MAIN LABELThe sensor model Sigma M is available in two product type. The exacttype of the device is shown on the main label.    Fig 5.1. Label on CE-marked deviceMAC is a unique MAC-address of the internal WLAN terminal.The main label with the serial number of the product of the device isattached to the battery cover. The battery cover must not be replacedby an unauthorized person. Contact your local dealer for servicing adamaged cover if needed.5.4 MANUALSThe following manuals and documents are shipped with the Sigma Msystem:• Sigma M User Quick Guide• Sigma M Installation Manual• Sigma M User Manual• CliniView User Manual• CliniView Installation Manual5.5 DISPOSALAt the end of useful working life of the device, its spare andreplacement parts and accessories make sure that you follow all local,national and international regulations regarding the correct and safedisposal and/or recycling of the device, its spare and replacementparts and accessories. The device and its spare and replacement parts and accessories mayinclude parts that are made of or include materials that are non-environmentally friendly or hazardous. These parts must be disposedof in accordance with all local, national and international regulationsregarding the disposal of non-environmentally friendly or hazardousmaterials.The following hazardous materials and substances can be found in thedevice its spare and replacement parts and assemblies:Type Description Part numberS1 Sensor size 1 900003S2 Sensor size 2 9000045 General information30 Instrumentarium Dental 200150  rev 35.3 MAIN LABELThe sensor model Sigma M is available in two product type. The exacttype of the device is shown on the main label.    Fig 5.1. Label on CE-marked deviceMAC is a unique MAC-address of the internal WLAN terminal.The main label with the serial number of the product of the device isattached to the battery cover. The battery cover must not be replacedby an unauthorized person. Contact your local dealer for servicing adamaged cover if needed.5.4 MANUALSThe following manuals and documents are shipped with the Sigma Msystem:• Sigma M User Quick Guide• Sigma M Installation Manual• Sigma M User Manual• CliniView User Manual• CliniView Installation Manual5.5 DISPOSALAt the end of useful working life of the device, its spare andreplacement parts and accessories make sure that you follow all local,national and international regulations regarding the correct and safedisposal and/or recycling of the device, its spare and replacementparts and accessories. The device and its spare and replacement parts and accessories mayinclude parts that are made of or include materials that are non-environmentally friendly or hazardous. These parts must be disposedof in accordance with all local, national and international regulationsregarding the disposal of non-environmentally friendly or hazardousmaterials.The following hazardous materials and substances can be found in thedevice its spare and replacement parts and assemblies:Type Description Part numberS1 Sensor size 1 900003S2 Sensor size 2 900004ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
5 General information200150  rev  3 Instrumentarium Dental 31– lead (Pb): sensor, circuit boardThe locations of all the spare and replacement parts and assemblieslisted above can be found in the service and/or installation manualsupplied with the device.5.6 WARNINGS• Minimize the number of running programs before image capturingto ensure the necessary operating system resources for theprocess.• Computer should only be connected to grounded outlet• Do not forcefully bend sensor cables. Avoid mechanical wear andstress (pulling the cable)• Use only the power supply specified by the manufacturer• Make sure that the Ready LED illuminates before making anexposure.• Don't sterilize the sensor using autoclave or UV oven• Use a disposable hygienic cover or disinfect the sensor afterevery patient• The battery is harmful to the environment and so it must bedisposed 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 theelectronics• Connect the system only to a PC conforming with IEC60950 orIEC60601-15.7 NOTICE OF WIRELESS LAN USAGEWLAN operation is based on emitting and receiving RF energy.This equipment complies with European R & TTE directives, and maybe operated without a licence in Europe (ETSI). The declaration ofconformity can be consulted at Instrumentarium Dental. Although thisand other use environment devices comply with CISPR requirementsfor RF emissions, interference may still occur.Monitor the performance of the wireless link. If it behaves in a strangeor unexpected way that may endanger patient safety, use the USBconnecting 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.5 General information200150  rev  3 Instrumentarium Dental 31– lead (Pb): sensor, circuit boardThe locations of all the spare and replacement parts and assemblieslisted above can be found in the service and/or installation manualsupplied with the device.5.6 WARNINGS• Minimize the number of running programs before image capturingto ensure the necessary operating system resources for theprocess.• Computer should only be connected to grounded outlet• Do not forcefully bend sensor cables. Avoid mechanical wear andstress (pulling the cable)• Use only the power supply specified by the manufacturer• Make sure that the Ready LED illuminates before making anexposure.• Don't sterilize the sensor using autoclave or UV oven• Use a disposable hygienic cover or disinfect the sensor afterevery patient• The battery is harmful to the environment and so it must bedisposed 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 theelectronics• Connect the system only to a PC conforming with IEC60950 orIEC60601-15.7 NOTICE OF WIRELESS LAN USAGEWLAN operation is based on emitting and receiving RF energy.This equipment complies with European R & TTE directives, and maybe operated without a licence in Europe (ETSI). The declaration ofconformity can be consulted at Instrumentarium Dental. Although thisand other use environment devices comply with CISPR requirementsfor RF emissions, interference may still occur.Monitor the performance of the wireless link. If it behaves in a strangeor unexpected way that may endanger patient safety, use the USBconnecting 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.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
5 General information32 Instrumentarium Dental 200150  rev 35.8 FCC CERTIFICATIONThis device complies with Part 15 of the FCC Rules. Operation issubject to the following two conditions:1 This device may not cause harmful interference2 This device must accept any interference received, includinginterference that may cause undesired operation.Changes or modifications not expressly approved by the partyresponsible for compliance could void the user’s authority to operatethe equipment.NOTE!This equipment has been tested and found to comply with the limits forClass B digital device, pursuant to Part 15 or the FCC Rules. Theselimits are designed to provide reasonable protection against harmfulinterference in residential installation. This equipment generates, usesand can radiate radio frequency energy and, if not installed and usedin accordance with the instruction manual, may cause harmfulinterference to radio communications. However, there is no guaranteethat interference will not occur in a particular installation. If this devicedoes cause harmful interference to radio or television reception, whichcan be determined by turning the equipment off and on, the user isencouraged to try to correct the interference by one or more of thefollowing 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 helpSigma M sensor5 General information32 Instrumentarium Dental 200150  rev 35.8 FCC CERTIFICATIONThis device complies with Part 15 of the FCC Rules. Operation issubject to the following two conditions:1 This device may not cause harmful interference2 This device must accept any interference received, includinginterference that may cause undesired operation.Changes or modifications not expressly approved by the partyresponsible for compliance could void the user’s authority to operatethe equipment.NOTE!This equipment has been tested and found to comply with the limits forClass B digital device, pursuant to Part 15 or the FCC Rules. Theselimits are designed to provide reasonable protection against harmfulinterference in residential installation. This equipment generates, usesand can radiate radio frequency energy and, if not installed and usedin accordance with the instruction manual, may cause harmfulinterference to radio communications. However, there is no guaranteethat interference will not occur in a particular installation. If this devicedoes cause harmful interference to radio or television reception, whichcan be determined by turning the equipment off and on, the user isencouraged to try to correct the interference by one or more of thefollowing 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 helpSigma M sensorApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
6 Technical specifications200150  rev  3 Instrumentarium Dental 336 Technical specifications6.1 GENERALDManufacturer´s quality system: ISO 9001, ISO 13485Electrical and Mechanical safety: Medical Equipment with respect to electrical shock, fire and mechanical hazards only in accordance with UL60601, CAN/CSA C22.2 no 601.1According 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) compliantPatient connection (sensor): BF-typeSensor technology: CMOS Active Pixel technology (CMOS APS)IMAGE QUALITYResolution: 26.3 lp/mm (theoretical)Grayscale: 4096 gray levels.Holders: A full set of color coded KerrHawe and Sigma M sensor holders, with easy instructions, for comfortable and accurate positioning.SOFTWARE MAIN FEATURESOperating system: Windows 2000 or XP (SP2)Operating software: CliniView version 6.4 or laterFull Mouth Series: FMS, user definedFile sizes: 3,17 MB, uncompressed file,Sensor size1 4,96 MB, uncompressed file,Sensor size2X-ray shield in the sensor: Lead (Pb)6.2 DIMENSIONSOuter dimensions: Sensor unit: 102 x 60 x 22 mmSensor size 1: 26 x 37 mmSensor size 2: 31 x 44 mmActive image area: Sensor size 1: 30.02 x 19,95 mm2Sensor size 2: 36,48 x 25,84 mm26 Technical specifications200150  rev  3 Instrumentarium Dental 336 Technical specifications6.1 GENERALDManufacturer´s quality system: ISO 9001, ISO 13485Electrical and Mechanical safety: Medical Equipment with respect to electrical shock, fire and mechanical hazards only in accordance with UL60601, CAN/CSA C22.2 no 601.1According 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) compliantPatient connection (sensor): BF-typeSensor technology: CMOS Active Pixel technology (CMOS APS)IMAGE QUALITYResolution: 26.3 lp/mm (theoretical)Grayscale: 4096 gray levels.Holders: A full set of color coded KerrHawe and Sigma M sensor holders, with easy instructions, for comfortable and accurate positioning.SOFTWARE MAIN FEATURESOperating system: Windows 2000 or XP (SP2)Operating software: CliniView version 6.4 or laterFull Mouth Series: FMS, user definedFile sizes: 3,17 MB, uncompressed file,Sensor size1 4,96 MB, uncompressed file,Sensor size2X-ray shield in the sensor: Lead (Pb)6.2 DIMENSIONSOuter dimensions: Sensor unit: 102 x 60 x 22 mmSensor size 1: 26 x 37 mmSensor size 2: 31 x 44 mmActive image area: Sensor size 1: 30.02 x 19,95 mm2Sensor size 2: 36,48 x 25,84 mm2ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
6 Technical specifications34 Instrumentarium Dental 200150  rev 3Sensor shape: Four rounded corners, two corners with greater radius for better patient comfort in Sensor size 2.PIXEL SIZESensor size 1: 19 µm x 19 µm 1580 x 1050 pixelsSensor size 2: 19 µm x 19 µm 1916 x 1358 pixelsSensor cable length Sensor size 1: 40 cmSensor size 2: 40 cm6.3 SENSOR UNITSensor unit box: 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.PC connection: 802.11b/g 2.4 GHz Access Point or USBUSB: USB 2.0 Full speed, mini USB-B port connector, 500 mA.USB cable length: maximum 3 meters (9,8 feet), ferrite required.General applied part (sensor): BF typeBattery type: Rechargable lithium Polymer batteryBattery capacity: 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 positive6.4 RF EXPOSURE INFOWLAN: According to IEEE 802.11bFrequency: 2400 MHz - 2483 MHzOutput power: max 0,25 W (FCC)max 0,1 W (ETSI)Separation: Keep the sensor unit min. 20 cm away from the patient6 Technical specifications34 Instrumentarium Dental 200150  rev 3Sensor shape: Four rounded corners, two corners with greater radius for better patient comfort in Sensor size 2.PIXEL SIZESensor size 1: 19 µm x 19 µm 1580 x 1050 pixelsSensor size 2: 19 µm x 19 µm 1916 x 1358 pixelsSensor cable length Sensor size 1: 40 cmSensor size 2: 40 cm6.3 SENSOR UNITSensor unit box: 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.PC connection: 802.11b/g 2.4 GHz Access Point or USBUSB: USB 2.0 Full speed, mini USB-B port connector, 500 mA.USB cable length: maximum 3 meters (9,8 feet), ferrite required.General applied part (sensor): BF typeBattery type: Rechargable lithium Polymer batteryBattery capacity: 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 positive6.4 RF EXPOSURE INFOWLAN: According to IEEE 802.11bFrequency: 2400 MHz - 2483 MHzOutput power: max 0,25 W (FCC)max 0,1 W (ETSI)Separation: Keep the sensor unit min. 20 cm away from the patientApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
6 Technical specifications200150  rev  3 Instrumentarium Dental 356.6 IMAGE ACQUISITION SYSTEM REQUIREMENTSThe Sigma M acquisition system consists of Sigma M sensor and PChardware. Sigma M sensor is a medical device.WARNING!If a IEC 60950-compliant (non-medical) PC is used, it must not bebrought in to the patient environment (see Sigma M installationmanual for details).WARNING!Do not bring open (unconnected) USB cable to the patient area. If thesensor is used with USB cable in the patient area, the user must makesure that system leakage current does not exceed IEC/ISO 60601-1-1limits (see Sigma M installation manual for details).6.5 AMBIENT CONDITIONSThe Sigma M unitTransportation and storage temperature: -40°...+60°C (-40F...+158F), note battery discharge during long storage and high temperatureOperating temperature: +10°...+40°C (+50F...+104F)Relative humidity (storage): 10-93%Water tightness: IP67 (sensor)IP21 (sensor unit)The batteryCharge Temperature Charge: 0°...+45°C (+32F...+113F)Storage Temperature and time to prevent self discharge 1 Year at-20°...+20°C (-4F...+68F)3 Month at-20°...+45°C (-4F...+113F) 1 Month at-20°...+60°C (-4F...+140F)MaterialsSensor cover PASensor cable PURHygienic cover Ethylene Methyl Acrylate Copolymer6 Technical specifications200150  rev  3 Instrumentarium Dental 356.6 IMAGE ACQUISITION SYSTEM REQUIREMENTSThe Sigma M acquisition system consists of Sigma M sensor and PChardware. Sigma M sensor is a medical device.WARNING!If a IEC 60950-compliant (non-medical) PC is used, it must not bebrought in to the patient environment (see Sigma M installationmanual for details).WARNING!Do not bring open (unconnected) USB cable to the patient area. If thesensor is used with USB cable in the patient area, the user must makesure that system leakage current does not exceed IEC/ISO 60601-1-1limits (see Sigma M installation manual for details).6.5 AMBIENT CONDITIONSThe Sigma M unitTransportation and storage temperature: -40°...+60°C (-40F...+158F), note battery discharge during long storage and high temperatureOperating temperature: +10°...+40°C (+50F...+104F)Relative humidity (storage): 10-93%Water tightness: IP67 (sensor)IP21 (sensor unit)The batteryCharge Temperature Charge: 0°...+45°C (+32F...+113F)Storage Temperature and time to prevent self discharge 1 Year at-20°...+20°C (-4F...+68F)3 Month at-20°...+45°C (-4F...+113F) 1 Month at-20°...+60°C (-4F...+140F)MaterialsSensor cover PASensor cable PURHygienic cover Ethylene Methyl Acrylate CopolymerApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
6 Technical specifications36 Instrumentarium Dental 200150  rev 36.7 ELECTROMAGNETIC COMPATIBILITY (EMC) TABLESThese  Electromagnetic Compatibility tables according toIEC 60601-1-2 Ed 2 in chapter 7.5 consists of:WARNING!When used Sigma M adjacent to other equipment such configurationshould be carefully observed to ensure that electromagneticinterference (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 themanufacturer.Sigma M IMAGE ACQUISITION SYSTEM REQUIREMENTSElectrical safety IEC 60950 for office useor IEC/ISO 60601-1 (medical PC)Processor Pentium® 600MHz or better (Windows 2000)Pentium® 600MHz or better (Windows XP)Hard disk 10 GBCD-ROM YesKeyboard YesMouse YesUSB port YesAccessories Audiocard and speakers optionalOperating system Windows® 2000Windows® XP (SP2)See Microsoft Windows System RequirementsMain memory (RAM) Windows® 2000 and XP: 256 MB or moreMonitor 15” or biggerArchive CD-RDATIomega®Jazz®MODWLAN network adapter IEEE 802.11 b compatible (built in, USB, access point or equivalent)6 Technical specifications36 Instrumentarium Dental 200150  rev 36.7 ELECTROMAGNETIC COMPATIBILITY (EMC) TABLESThese  Electromagnetic Compatibility tables according toIEC 60601-1-2 Ed 2 in chapter 7.5 consists of:WARNING!When used Sigma M adjacent to other equipment such configurationshould be carefully observed to ensure that electromagneticinterference (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 themanufacturer.Sigma M IMAGE ACQUISITION SYSTEM REQUIREMENTSElectrical safety IEC 60950 for office useor IEC/ISO 60601-1 (medical PC)Processor Pentium® 600MHz or better (Windows 2000)Pentium® 600MHz or better (Windows XP)Hard disk 10 GBCD-ROM YesKeyboard YesMouse YesUSB port YesAccessories Audiocard and speakers optionalOperating system Windows® 2000Windows® XP (SP2)See Microsoft Windows System RequirementsMain memory (RAM) Windows® 2000 and XP: 256 MB or moreMonitor 15” or biggerArchive CD-RDATIomega®Jazz®MODWLAN network adapter IEEE 802.11 b compatible (built in, USB, access point or equivalent)ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
6 Technical specifications200150  rev  3 Instrumentarium Dental 37WARNING!USE LIMITATION: External components: The use of accessories,transducers, and cables other than those specified may result indegraded ELECTROMAGNETIC COMPATIBILITY of theEQUIPMENT and/or SYSTEM.WARNING!Portable and mobile RF communications equipment can affect thesystem. The Sigma is suitable for use in the specified electromagnetic environment. The purchaser oruser of the Sigma should assure that it is used in an electromagnetic environment as describedbelow:Emissions Test Compliance Electromagnetic EnvironmentRadio-FrequencyEmissionsCISPR11Group 2 The Sigma M must emit electromagnetic energy in order to perform it’s intended function. Nerby electronic equipment may be affected.Radio-FrequencyEmissionsCISPR11Class 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 emissionsIEC 61000-3-2IEC 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.Voltage fluctuations/flicker emissionsIEC 61000-3-3Complies 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.Table 6.1 Electromagnetic emissions IEC 60601-1-2 Ed 2.6 Technical specifications200150  rev  3 Instrumentarium Dental 37WARNING!USE LIMITATION: External components: The use of accessories,transducers, and cables other than those specified may result indegraded ELECTROMAGNETIC COMPATIBILITY of theEQUIPMENT and/or SYSTEM.WARNING!Portable and mobile RF communications equipment can affect thesystem. The Sigma is suitable for use in the specified electromagnetic environment. The purchaser oruser of the Sigma should assure that it is used in an electromagnetic environment as describedbelow:Emissions Test Compliance Electromagnetic EnvironmentRadio-FrequencyEmissionsCISPR11Group 2 The Sigma M must emit electromagnetic energy in order to perform it’s intended function. Nerby electronic equipment may be affected.Radio-FrequencyEmissionsCISPR11Class 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 emissionsIEC 61000-3-2IEC 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.Voltage fluctuations/flicker emissionsIEC 61000-3-3Complies 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.Table 6.1 Electromagnetic emissions IEC 60601-1-2 Ed 2.ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
6 Technical specifications38 Instrumentarium Dental 200150  rev 3Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2Frequency of TransmitterEquationRated Maximum Output Power of Transmitter (watts)150KHz to 80 MHzSeparation Distance (meters)80 MHz to 800 MHzSeparation Distance(meters)800 MHz to 2,5 GHzSeparation Distance(meters)0.01 0.12 0.12 0.230.1 0.37 0.37 0.741 1.17 1.17 2.3410 3.69 3.69 7.38100 11.67 11.67 23.34Table 6.2 Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2 Ed 2.PV = d]5,3[1PE = d]5,3[1PE = d]7[16 Technical specifications38 Instrumentarium Dental 200150  rev 3Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2Frequency of TransmitterEquationRated Maximum Output Power of Transmitter (watts)150KHz to 80 MHzSeparation Distance (meters)80 MHz to 800 MHzSeparation Distance(meters)800 MHz to 2,5 GHzSeparation Distance(meters)0.01 0.12 0.12 0.230.1 0.37 0.37 0.741 1.17 1.17 2.3410 3.69 3.69 7.38100 11.67 11.67 23.34Table 6.2 Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2 Ed 2.PV = d]5,3[1PE = d]5,3[1PE = d]7[1ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
6 Technical specifications200150  rev  3 Instrumentarium Dental 39Sigma M is suitable for use in the specified electromagnetic environment. The purchaser or userof Sigma M should assure that it is used in an electromagnetic environment as described below:Immunity Test IEC 60601-1-2Test Level ComplianceLevel Electromagnetic EnvironmentElectrostatic 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 dischargeFloors 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/burstIEC 61000-4-4± 2 kV for power supply lines± 1 kV for input/outputlines± 2 kV for power supply lines± 1 kV for input/outputlinesMains power quality is that of a typical commercial and/or hospital environmentSurgeIEC 61000-4-5± 1 kV differential mode± 2 kV common mode± 1 kV differential mode± 2 kV common modeMains power quality is that of a typical commercial and/or hospital environment.Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11< 5 % UT(> 95 % dip in UT) for 0,5 cycle40 % UT(60 % dip in UT) for 5 cycles70 % UT(30 % dip in UT) for 25 cycles< 5 % UT(> 95 % dip in UT)< 5 % UT(> 95 % dip in UT) for 0,5 cycle40 % UT(60 % dip in UT) for 5 cycles70 % 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 fieldIEC 61000-4-83 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 Ed26 Technical specifications200150  rev  3 Instrumentarium Dental 39Sigma M is suitable for use in the specified electromagnetic environment. The purchaser or userof Sigma M should assure that it is used in an electromagnetic environment as described below:Immunity Test IEC 60601-1-2Test Level ComplianceLevel Electromagnetic EnvironmentElectrostatic 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 dischargeFloors 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/burstIEC 61000-4-4± 2 kV for power supply lines± 1 kV for input/outputlines± 2 kV for power supply lines± 1 kV for input/outputlinesMains power quality is that of a typical commercial and/or hospital environmentSurgeIEC 61000-4-5± 1 kV differential mode± 2 kV common mode± 1 kV differential mode± 2 kV common modeMains power quality is that of a typical commercial and/or hospital environment.Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11< 5 % UT(> 95 % dip in UT) for 0,5 cycle40 % UT(60 % dip in UT) for 5 cycles70 % UT(30 % dip in UT) for 25 cycles< 5 % UT(> 95 % dip in UT)< 5 % UT(> 95 % dip in UT) for 0,5 cycle40 % UT(60 % dip in UT) for 5 cycles70 % 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 fieldIEC 61000-4-83 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 Ed2ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
6 Technical specifications40 Instrumentarium Dental 200150  rev 3Sigma M is suitable for use in the specified electromagnetic environment. The purchaser or userof Sigma M should assure that it is used in an electromagnetic environment as described below:ImmunityTest IEC60601-1-2Test LevelComplianceLevel ElectromagneticEnvironmentConducted RF IEC 61000-4-6Radiated RFIEC 61000-4-33 V150 kHz to80 MHz3 V/m80 MHz to2,5 GHz[ V1 ] 3 V[ E1 ] 3 V/mPortable 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: 80 MHz to 800 MHz 800 MHz to 2,5 GHzWhere 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 landmobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot beestimated accurately. To assess the electromagnetic environment due to fixed RF transmitters,an electromagnetic site survey should be performed. If the measured field strength exceeds theRF compliance level above, observe Sigma M to verify normal operation in each use location. Ifabnormal performance is observed, additional measures may be necessary, such as re-orientingor 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 affectedby absorption and reflection from structures, objects, and people.Table 6.4  RF immunity of non-life-support equipment or system IEC 60601-1-2PV = d]5,3[1PE = d]5,3[1PE = d]7[16 Technical specifications40 Instrumentarium Dental 200150  rev 3Sigma M is suitable for use in the specified electromagnetic environment. The purchaser or userof Sigma M should assure that it is used in an electromagnetic environment as described below:ImmunityTest IEC60601-1-2Test LevelComplianceLevel ElectromagneticEnvironmentConducted RF IEC 61000-4-6Radiated RFIEC 61000-4-33 V150 kHz to80 MHz3 V/m80 MHz to2,5 GHz[ V1 ] 3 V[ E1 ] 3 V/mPortable 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: 80 MHz to 800 MHz 800 MHz to 2,5 GHzWhere 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 landmobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot beestimated accurately. To assess the electromagnetic environment due to fixed RF transmitters,an electromagnetic site survey should be performed. If the measured field strength exceeds theRF compliance level above, observe Sigma M to verify normal operation in each use location. Ifabnormal performance is observed, additional measures may be necessary, such as re-orientingor 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 affectedby absorption and reflection from structures, objects, and people.Table 6.4  RF immunity of non-life-support equipment or system IEC 60601-1-2PV = d]5,3[1PE = d]5,3[1PE = d]7[1ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
7 Appendix 1, Sigma M products and accessories200150  rev  3 Instrumentarium Dental 417 Appendix 1, Sigma M products and accessoriesA Sigma M system (with the exception of the PC) is assembled usingthe following parts:The following accessories are approved parts:ProductsPart no. Description900003 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 magnet900004 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 magnetAccessoriesPart no. Description55042 Sigma M hygienic covers (500 pcs)200382 Sigma M Charger, EUR200383 Sigma M Charger, USA5169795 Rechargable Battery5169703 Mounting Magnet200245 Wall Mount set200162 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 pc7 Appendix 1, Sigma M products and accessories200150  rev  3 Instrumentarium Dental 417 Appendix 1, Sigma M products and accessoriesA Sigma M system (with the exception of the PC) is assembled usingthe following parts:The following accessories are approved parts:ProductsPart no. Description900003 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 magnet900004 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 magnetAccessoriesPart no. Description55042 Sigma M hygienic covers (500 pcs)200382 Sigma M Charger, EUR200383 Sigma M Charger, USA5169795 Rechargable Battery5169703 Mounting Magnet200245 Wall Mount set200162 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 pcApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
7 Appendix 1, Sigma M products and accessories42 Instrumentarium Dental 200150  rev 3200163 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 pc200333 Bitewing Refill S1 Refill Pack, 10 pcs200335 Posterior S1 Refill pack, 10 pcs200337 Periapical S1 Refill Pack, 10 pcs200338 Endo S1 Refill Pack, 10 pcs200334 Positioning ring Refill Pack, 5 pcs200339 Bitewing S2 Refill Pack, 10 pcs200340 Posterior S2 Refill pack, 10 pcs200330 Super-Bite Senso Holders (KerrHawe)- Super-Bite Senso Anterior 2 pcs- Super-Bite Senso Posterior 2 pcs200331 Kwik-Bite Senso Holders (KerrHawe)- Kwik-Bite Senso 4 pcs200332 Endo-Bite Senso Holders (KerrHawe)- Endo-Bite Senso Anterior 2 pcs- Endo-Bite Senso Posterior 2 pcsAccessoriesPart no. Description7 Appendix 1, Sigma M products and accessories42 Instrumentarium Dental 200150  rev 3200163 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 pc200333 Bitewing Refill S1 Refill Pack, 10 pcs200335 Posterior S1 Refill pack, 10 pcs200337 Periapical S1 Refill Pack, 10 pcs200338 Endo S1 Refill Pack, 10 pcs200334 Positioning ring Refill Pack, 5 pcs200339 Bitewing S2 Refill Pack, 10 pcs200340 Posterior S2 Refill pack, 10 pcs200330 Super-Bite Senso Holders (KerrHawe)- Super-Bite Senso Anterior 2 pcs- Super-Bite Senso Posterior 2 pcs200331 Kwik-Bite Senso Holders (KerrHawe)- Kwik-Bite Senso 4 pcs200332 Endo-Bite Senso Holders (KerrHawe)- Endo-Bite Senso Anterior 2 pcs- Endo-Bite Senso Posterior 2 pcsAccessoriesPart no. DescriptionApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
Sigma M User Manual, English200150   rev 3  Printed in Finland   04/2007Instrumentarium 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 DentalP.O.Box 20, FI-04301 Tuusula, FinlandTel. +358 45 7882 2000Fax +358 45 7882 2506Americas:Instrumentarium Dental Inc.Milwaukee, Wisconsin, U.S.A.Tel. 800 558 6120Fax 414 481 8665Sigma M User Manual, English200150   rev 3  Printed in Finland   04/2007Instrumentarium 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 DentalP.O.Box 20, FI-04301 Tuusula, FinlandTel. +358 45 7882 2000Fax +358 45 7882 2506Americas:Instrumentarium Dental Inc.Milwaukee, Wisconsin, U.S.A.Tel. 800 558 6120Fax 414 481 8665ApprovedReviewed: Anttila Mika Johannes 02.05.07 09:54:49Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31

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