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User manual | Users Manual | 1.98 MiB | June 08 2007 | |||
1 | Cover Letter(s) | June 08 2007 | ||||||
1 | Cover Letter(s) | June 08 2007 | ||||||
1 | External Photos | June 08 2007 | ||||||
1 | ID Label/Location Info | June 08 2007 | ||||||
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1 | Test Report | June 08 2007 |
1 | User manual | Users Manual | 1.98 MiB | June 08 2007 |
Sigma M User Manual Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 r p A p 200150 rev 3 d e v o Sigma M User Manual200150 rev 3 Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 A p d e v o r p Copyright Code: 200150 rev 3 Date: 26 April 2007 Document code: D500616 rev 3 Copyright 04/2007 by PaloDEx Group Oy. All rights reserved. Documentation, trademark and the software are copyrighted with all rights reserved. Under the copyright laws the documentation may not be copied, photocopied, reproduced, translated, or reduced to any electronic medium or machine readable form in whole or part, without the prior written permission of Instrumentarium Dental. The original language of this manual is English. Instrumentarium Dental reserves the right to make changes in specification and features shown herein, or discontinue the product described at any time without notice or obligation. Contact your Instrumentarium Dental the most current information. representative for Manufactured by Instrumentarium Dental Nahkelantie 160 (P.O. Box 20) FI-04300 Tuusula FINLAND Tel. +358 45 7882 2000 Fax. +358 45 7882 2506 For service, contact your local distributor. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 A p d e v o r p CopyrightCode: 200150 rev 3 Date: 26 April 2007Document code: D500616 rev 3Copyright 04/2007 by PaloDEx Group Oy. All rightsreserved.Manufactured byInstrumentarium 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. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 A p d e v o r p Table of Contents 1 Sigma M system ....................................................................................... 1 1.1 Introduction ........................................................................................................... 1 1.2 Main parts of the Sigma M device......................................................................... 2 1.3 Accessories........................................................................................................... 3 1.4 Battery................................................................................................................... 5 2 Capturing intraoral images ..................................................................... 9 2.1 Before taking sensor into use................................................................................ 9 2.2 Indicators............................................................................................................. 10 2.3 Capturing image with one sensor........................................................................ 11 2.4 Using two sizes of sensors.................................................................................. 13 2.5 Sharing sensor with other users.......................................................................... 15 2.6 Taking images with USB cable connected.......................................................... 17 2.7 Recharging the battery........................................................................................ 18 2.8 Recommended exposure times .......................................................................... 19 3 Care instructions.................................................................................... 21 3.1 Cleaning the Sigma unit ...................................................................................... 21 3.2 Handling the device............................................................................................. 22 4 Trouble shooting.................................................................................... 23 4.1 Diagnosing image quality problems .................................................................... 23 4.2 Diagnosing equipment specific problems............................................................ 24 5 General information ............................................................................... 27 5.1 Manufacturers liability......................................................................................... 27 5.2 Markings and graphics symbols.......................................................................... 27 5.3 Main label............................................................................................................ 30 5.4 Manuals............................................................................................................... 30 5.5 Disposal .............................................................................................................. 30 5.6 Warnings ............................................................................................................. 31 5.7 Notice of wireless LAN usage ............................................................................. 31 5.8 FCC certification.................................................................................................. 32 6 Technical specifications........................................................................ 33 6.1 General ............................................................................................................... 33 6.2 Dimensions ......................................................................................................... 33 6.4 RF exposure info................................................................................................. 34 6.3 Sensor unit .......................................................................................................... 34 6.5 Ambient conditions.............................................................................................. 35 6.6 Image acquisition system requirements.............................................................. 35 6.7 Electromagnetic Compatibility (EMC) tables....................................................... 36 7 Appendix 1, Sigma M products and accessories................................ 41 Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v i 200150 rev 3Instrumentarium DentaliTable of Contents1Sigma M system.......................................................................................11.1Introduction...........................................................................................................11.2Main parts of the Sigma M device.........................................................................21.3Accessories...........................................................................................................31.4Battery...................................................................................................................52Capturing intraoral images.....................................................................92.1Before taking sensor into use................................................................................92.2Indicators.............................................................................................................102.3Capturing image with one sensor........................................................................112.4Using two sizes of sensors..................................................................................132.5Sharing sensor with other users..........................................................................152.6Taking images with USB cable connected..........................................................172.7Recharging the battery........................................................................................182.8Recommended exposure times..........................................................................193Care instructions....................................................................................213.1Cleaning the Sigma unit......................................................................................213.2Handling the device.............................................................................................224Trouble shooting....................................................................................234.1Diagnosing image quality problems....................................................................234.2Diagnosing equipment specific problems............................................................245General information...............................................................................275.1Manufacturers liability.........................................................................................275.2Markings and graphics symbols..........................................................................275.3Main label............................................................................................................305.4Manuals...............................................................................................................305.5Disposal..............................................................................................................305.6Warnings.............................................................................................................315.7Notice of wireless LAN usage.............................................................................315.8FCC certification..................................................................................................326Technical specifications........................................................................336.1General...............................................................................................................336.2Dimensions.........................................................................................................336.4RF exposure info.................................................................................................346.3Sensor unit..........................................................................................................346.5Ambient conditions..............................................................................................356.6Image acquisition system requirements..............................................................356.7Electromagnetic Compatibility (EMC) tables.......................................................367Appendix 1, Sigma M products and accessories................................41 Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental ii A p o r p d e v 200150 rev 3 iiInstrumentarium Dental200150 rev 3 1 Sigma M system 1 Sigma M system 1.1 INTRODUCTION Thank you for purchasing Instrumentarium Dental Sigma M digital intraoral sensor. The Sigma M sensor is intended for dental x-ray imaging. Sigma M produces high quality digital X-ray images of teeth and adjacent structures instantly without the need for film or chemicals. It allows the user to view, enhance, store, send and print images using the CliniView imaging software. Two sensor sizes are available for various dental X-ray imaging needs. Size 1: 1580 x 1050 pixel Size 2: 1916 x 1358 pixel 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 sensor type size 2 (S2) is to capture bitewing and horizontal periapical images. The sensor type is marked on the main label (see chapter Main label for details). The use of Sigma M system requires intraoral X-ray unit and a computer with a wireless network (Wi-Fi/Wlan) connectivity. USB port can be used for configuring the sensor or when the wireless (Wi-Fi/
Wlan) is temporarily unavailable. It is assumed here that the sensor system is properly installed and configured to operate in a desired WLAN network. See Sigma M installation manual and this Sigma M user manual for instructions. The Sigma M sensor is battery operated. The device is supplied with a rechargeable battery installed. Make sure that the battery is recharged prior the use of the sensor. Instructions for the Sigma M use include the following manuals:
Sigma M User Quick Guide Sigma M User Manual CliniView User Manual Read all the instructions carefully before the Sigma M use. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p r p o d e v 1 1 Sigma M system200150 rev 3Instrumentarium Dental11Sigma M system1.1INTRODUCTIONThank 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 GuideSigma M User ManualCliniView User ManualRead all the instructions carefully before the Sigma M use.Size 1: 1580 x 1050 pixelSize 2: 1916 x 1358 pixel 1 Sigma M system 1.2 MAIN PARTS OF THE SIGMA M DEVICE CONNECTORS BATTERY COVER Magnetic mounting guide Main label Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 2 A p o r p d e v 200150 rev 3 1 Sigma M system2Instrumentarium Dental200150 rev 31.2MAIN PARTS OF THE SIGMA M DEVICEMagneticmountingguideMain labelCONNECTORSBATTERY COVER 1.3 ACCESSORIES 1 Sigma M system Sigma M Charger included in the sales package available in various type for local mains voltage and approvals. Consult the local distributor for correct type, If spare part is needed. Magnet Mount included in the sales package the magnet place can be decided by the user
(see page 9) can be used for mounting the device during image capture procedure or during storage adhesive tape included for attaching the mount on tube head the Wall mount set included in the sales package for storage when not used and during battery charge screws included for wall mounting WARNING!
Do not place the magnet on the cover of PC and monitor, or nearby a pacemaker. USB cable included in the sales package WARNING!
Use only USB cable delivered with to ensure proper the device operation to specification. according Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 3 1 Sigma M system200150 rev 3Instrumentarium Dental31.3ACCESSORIESSigma M Chargerincluded in the sales packageavailable in various type forlocal mains voltage andapprovals. Consult the localdistributor for correct type, Ifspare part is needed.Magnet Mountincluded in the sales packagethe magnet place can bedecided by the user (see page 9)can be used for mounting thedevice during the imagecapture procedure or duringstorageadhesive tape included forattaching the mount on tubeheadWall mount setincluded in the sales packagefor storage when not usedand during battery chargescrews for wall mountingincludedWARNING!Do not place the magnet on thecover of PC and monitor, ornearby a pacemaker.USB cableincluded in the sales packageWARNING!Use only USB cable delivered withthe device to ensure properoperation according tospecification.
1 Sigma M system Sigma M Sensor holders
(optionally) available separately consult your local dealer for details KerrHawe Sensor holders
(optionally) available separately consult your local dealer for details Hygienic covers available separately SENSOR HOLDERS When taking intraoral images it is necessary to keep the sensor parallel to the tubehead. Correct positioning is assisted with the help of KerrHawe or Sigma M sensor holders. The sensor must be covered with a hygienic cover every time it is used. Only use hygienic covers similar to hygienic covers delivered with the Sigma M system by Instrumentarium Dental. NOTE!
The covers are protected against touch but they are not sterile. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 4 A p o r p d e v 200150 rev 3 1 Sigma M system4Instrumentarium Dental200150 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 separatelyconsult your local dealer fordetailsKerrHawe Sensor holders (optionally)available separatelyconsult your local dealer fordetailsHygienic covers available separately
1 Sigma M system SENSOR CABLE PLACEMENT To prevent the patient biting the sensor cable, lead the cable alongside the holder as instructed below:
CORRECT INCORRECT 1.4 BATTERY Sigma M Battery, Spare part number: 5169795 WARNING!
Replace the battery only with Instrumentarium Dental Sigma M battery, part no. 5169795. Charging with equipment other than the original Sigma M charger may cause heat generation or cell leakage. Use of another battery may present a risk of fire or explosion. See instructions for replacing the battery. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 5 1 Sigma M system200150 rev 3Instrumentarium Dental5SENSOR CABLE PLACEMENTTo prevent the patient biting the sensor cable, lead the cablealongside the holder as instructed below:1.4BATTERYSigma 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 INCORRECT 1 Sigma M system CHECKING BATTERY STATUS The remaining battery charge level is displayed in CliniView, next to the sensor status, when the sensor is in image capture mode. The battery status can be checked also by clicking Help/system info
(Sigma M sheet), when the sensor is in image capture mode. If the batterys voltage drops below 3700 mV, the CliniView software informs the user about low battery. Normal operation voltage is 3700-
4200 mV. Below 3500 mV the sensor does not turn on. REPLACING BATTERY If battery operation has drastically decreased, a change of battery is recommended. Battery capacity will decrease over time. The battery should be replaced at intervals of 1-3 years or after 500 recharge cycles. Replace only with original Sigma M battery (order part number 5169795). Opening the battery cover must be done so that the cover does not get damaged. 1 Switch off the Sigma M sensor and open the battery cover screw Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 6 A p o r p d e v 200150 rev 3 1 Sigma M system6Instrumentarium Dental200150 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 batterys 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.1Switch off the Sigma M sensor and open the battery cover screw 1 Sigma M system 2 Push the cover in the direction indicated by an arrow and remove the cover carefully. Make sure not to bend the cover when removing it. Disconnect the battery cable and dispose of the battery properly. 3 Replace with a new battery. Do not shortcut the poles of the battery, it may cause danger of explosion. CAUTION!
The battery used in this device may present a fire or a chemical burn hazard if mistreated. Do not dissemble, heat to 100C (212 F) or incinerate. NOTE!
The battery is harmful to the environment and so it must be disposed of in accordance with local regulations. WARNING!
The battery may explode if two poles are short-circuited. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 7 1 Sigma M system200150 rev 3Instrumentarium Dental7 2Push 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. 3Replace 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 100C (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 system Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 8 A p o r p d e v 200150 rev 3 1 Sigma M system8Instrumentarium Dental200150 rev 3 2 Capturing intraoral images 2 Capturing intraoral images 2.1 BEFORE TAKING SENSOR INTO USE Refer to chapter Technical Specifications and Image Acquisition System Requirements for hardware requirement. 1 Make sure the CliniView software (version 6.4.1 or later) has been installed properly. 2 Make sure the necessary WLAN equipments have been installed and WLAN network is working properly. 4 3 Make sure Sigma M sensor(s) has been properly configured to operate in the desired WLAN network. See CliniView installation manual and Sigma M installation manual for details. The sensor unit is rechargeable battery operated. It is recharged with the included Sigma M charger. A daily recharge is recommended. Approximately 200 exposures can be taken with a fully recharged battery. Before using the sensor, make sure the battery has been recharged. Connect the charger connector to the Sigma M charger. The sensor cannot be used when recharging batteries. Disinfect the sensor and the cable before the patient work. 5 NOTE!
Use the magnet included in the sales package to mount the sensor on the X-ray tube head for ergonomic and efficient workflow. NOTE!
Ask your sensor dealer for holder offering designed for the Sigma M sensor. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 9 2 Capturing intraoral images200150 rev 3Instrumentarium Dental92Capturing intraoral images2.1BEFORE TAKING SENSOR INTO USERefer to chapter Technical Specifications and Image AcquisitionSystem Requirements for hardware requirement.1Make sure the CliniView software (version 6.4.1 or later) hasbeen installed properly.2Make sure the necessary WLAN equipments have been installedand WLAN network is working properly.3Make 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.4The 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.5Disinfect 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 images 2.2 INDICATORS Device status indicator Battery status indicator Indicator Orange Green Green blinking Device status Power on Ready for image capture Image integration Orange blinking Image transmission Orange blinking fast Indicator Battery status Orange blinking Low battery (a few images can still be captured to complete the patient) Critically low battery (image capturing not recommended) Battery charging Charge complete, battery is OK Orange Off Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 10 A p o r p d e v 200150 rev 3 2 Capturing intraoral images10Instrumentarium Dental200150 rev 32.2INDICATORSDevice status indicatorIndicatorDevice statusOrangePower onGreenReady for image captureGreen blinkingImage integrationOrange blinkingImage transmissionBattery status indicatorIndicatorBattery statusOrange blinkingLow battery (a few images can still be captured to complete the patient)Orange blinking fastCritically low battery (image capturing not recommended)OrangeBattery chargingOffCharge complete, battery is OK 2 Capturing intraoral images 2.3 CAPTURING IMAGE WITH ONE SENSOR POWER SWITCH It is assumed here that one, either size 1 or size 2 sensor, is selected from the Installed device -menu on the CliniView software. It is also assumed that this sensor is selected as a default sensor device using the Tools-Intra-Sigma M settings -menu of the CliniView software. See the Sigma M installation manual for details. 1 2 Start CliniView software and select a patient. Switch on the sensor by pressing the sensor power switch. NOTE!
For efficient work flow the sensor and Cliniview capture mode can be turned on well before inserting the sensor into the patient's mouth. Consequently the system will be immediately ready for capture when the sensor is in place. If you forget to power the sensor at the beginning of the workflow you can do it also later before the image capture. 3 Protect the sensor with a hygienic cover and place the sensor on to the holder. Hold the hygienic cover with the paper side pointing downwards. Carefully insert the sensor between the white tab and the base paper. Peel away the upper transparent protective foil completely. Peel away the base paper completely from the underside. 4 Start image capturing in Cliniview by pressing the Start intraoral image capturing -button. NOTE!
The exposure must be made within 15 minutes maximum after clicking the Start intraoral image capturing button, depending on the time-out setting in the CliniView software. As well as the CliniView time-out setting, the sensor also has a power off timer. NOTE!
The other image capture icon can be used for capturing image using the template if several image are taken in series. 5 Position the sensor in the patients mouth. The sensor unit can be either on the patient's chest or with the magnetic mounting on the side of the X-ray unit tube head. Position the Intraoral X-ray unit as appropriate. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 11 2 Capturing intraoral images200150 rev 3Instrumentarium Dental112.3CAPTURING 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.1Start CliniView software and select a patient.2Switch 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.3Protect 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.4Start 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.5Position the sensor in the patients 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 SWITCH
2 Capturing intraoral images NOTE!
Make sure that the device status indicator illumates green before making the exposure. 6 Make the exposure by pressing the exposure button of the x-ray unit. Blinking status indicator on the device indicates image transfer. NOTE!
If several images are captured in series, do not switch the sensor off between the exposures. The auto power off will turn the sensor off, if the sensor is not used approximately in 10 minutes. 7 After the image capturing click Abort image capturing button in CliniView. 1 When capturing is finished switch the sensor off, remove disposable covers and disinfect the sensor if necessary. WARNING!
During the exposure cycle radiation the control protection guidelines must be observed. WARNING!
Minimize the number of running programs before image capturing to ensure the necessary operating system resources for the process. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 12 A p o r p d e v 200150 rev 3 2 Capturing intraoral images12Instrumentarium Dental200150 rev 3NOTE!Make sure that the device status indicator illumates green beforemaking the exposure.6Make 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.7After the image capturing click Abort image capturing button inCliniView.1When 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 images 2.4 USING TWO SIZES OF SENSORS It is assumed here that both sensor size 1 and sensor size 2 have been installed and enabled from the installed device -menu on the Cliniview software. It is also assumed that the appropriate sensor device has been configured as the default sensor device using the Tools - Intra-Sigma M settings -menu of the Cliniview software. See the Sigma M installation manual for details. When both sensor sizes are installed, image capturing icons for both size 1 and size 2 sensors are displayed in the CliniView software. The image capturing can be started for either one or two sensors. Buttons from left to right:
- Image capturing with template (size 2)
- Quick image capturing (size 2)
- Image capturing with template (size 1)
- Quick image capturing (size 1) The image capture can be started as described in the previous chapter, with either of the sensors installed in the system. It is also possible to use both size 1 and size 2 sensor during one image capture session. NOTE!
Both sensors can be activated simultaneously by clicking image capture icon of both sensor before exposure. The sensor that receive x-ray sends the image to CliniView. The other sensor remains ready for exposure. If two sensors are activated simultaneously, there will be two sensor status bars on the PC screen. 1 2 3 4 5 Start CliniView software and select a patient. Switch on the sensors to be used by pressing the sensor power switch. Protect the sensor with a hygienic cover and place the sensor to the holder. Start image capturing in Cliniview by pressing the Start intraoral image capturing -button. Position the sensor in the patients mouth. The sensor unit can be either on patients chest or with the magnetic mounting on the side of the x-ray unit tube head. Position the Intraoral x-ray unit as appropriate. POWER SWITCH Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 13 2 Capturing intraoral images200150 rev 3Instrumentarium Dental132.4USING 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.1Start CliniView software and select a patient.2Switch on the sensors to be used by pressing the sensor powerswitch.3Protect the sensor with a hygienic cover and place the sensor tothe holder.4Start image capturing in Cliniview by pressing the Start intraoralimage capturing -button.5Position the sensor in the patients mouth. The sensor unit can beeither on patients chest or with the magnetic mounting on theside of the x-ray unit tube head. Position the Intraoral x-ray unit asappropriate.POWER SWITCH 2 Capturing intraoral images NOTE!
Make sure that the sensor, which is intended to use is powered on and ready image capture before exposure. Status indicator illuminates green when the sensor is ready. for 6 Make the exposure by pressing the exposure button of the x-ray unit. Blinking status indicator on the device indicates image transfer. NOTE!
If several images are captured in series, do not switch the sensor off between the exposures. The auto power off will turn the sensor off, if the sensor is not used approximately in 10 minutes. 7 After the image capturing click Abort image capturing button in CliniView. 8 When capturing is finished switch the sensor off, remove disposable covers and disinfect the sensor if necessary. WARNING!
During the exposure cycle radiation the control protection guidelines must be observed. WARNING!
Minimize the number of running programs before image capturing to ensure the necessary operating system resources for the process. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 14 A p o r p d e v 200150 rev 3 2 Capturing intraoral images14Instrumentarium Dental200150 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.6Make 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.7After the image capturing click Abort image capturing button inCliniView.8When 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 images 2.5 SHARING SENSOR WITH OTHER USERS It is assumed here that two or more workstations in different rooms have been configured to operate in the same Sigma M network. It is possible to use default sensor assignment for each room or alternatively select the sensor to be used from a list of available sensors in each image capture session. Select "Use preselected sensors" from Tools - Intra - Sigma M settings -menu to use default sensor assignment. See Sigma installation manual and user manual for details. NOTE!
Several rooms can select one shared sensor as their default sensor device. The sensor allows only one user at a time. If the sensor has been previously used by someone else, the user is asked to confirm selection when activated to avoid unintentional connection to the sensor. POWER SWITCH 1 2 3 4 5 6 Start CliniView software and select a patient. Switch on the sensors to be used by pressing the sensor power switch. Protect the sensor with a hygienic cover and place the sensor on to the holder. Start image capturing in CliniView by pressing the Start intraoral image capturing button of the appropriate sensor. If default sensor assignment -mode is not used, select the desired sensor from the Select device dialogue that opens. If the sensor has been transferred from one room to another, the user will be notified that the sensor was previously assigned to another workstation. Position the sensor in the patients mouth. The sensor unit can be either on patients chest or with the magnetic mounting on the side of the x-ray unit tube head. Position the Intraoral x-ray unit as appropriate. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 15 2 Capturing intraoral images200150 rev 3Instrumentarium Dental152.5SHARING 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. 1Start CliniView software and select a patient.2Switch on the sensors to be used by pressing the sensor powerswitch.3Protect the sensor with a hygienic cover and place the sensor onto the holder.4Start image capturing in CliniView by pressingthe Start intraoral image capturing button ofthe appropriate sensor.5If 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.6Position the sensor in the patients mouth. The sensor unit can beeither on patients chest or with the magnetic mounting on theside of the x-ray unit tube head. Position the Intraoral x-ray unit asappropriate.POWER SWITCH 2 Capturing intraoral images NOTE!
Make sure that the device status indicator illuminates green before making the exposure. 7 Make the exposure by pressing the exposure button of the x-ray unit. Blinking status indicator on the device indicates image transfer. NOTE!
If several images are captured in series, do not switch the sensor off between the exposures. The auto power off will turn the sensor off, if the sensor is not used approximately in 10 minutes. 8 After the image capturing click Abort image capturing button in CliniView. 9 When capturing is finished switch the sensor off, remove disposable covers and disinfect the sensor if necessary. WARNING!
During the exposure cycle radiation the control protection guidelines must be observed. WARNING!
Minimize the number of running programs before image capturing to ensure the necessary operating system resources for the process. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 16 A p o r p d e v 200150 rev 3 2 Capturing intraoral images16Instrumentarium Dental200150 rev 3NOTE!Make sure that the device status indicator illuminatesgreen before making the exposure.7Make 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.8After the image capturing click Abort image capturing button inCliniView.9When 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 images 2.6 TAKING IMAGES WITH USB CABLE CONNECTED NOTE!
The Windows XP operating system will open a Windows Explorer dialogue when Sigma M is connected via USB. Close this window. 1 2 3 4 5 Start CliniView software and select a patient Switch on the sensor by pressing the sensor power switch. Protect the sensor with a hygienic cover and place the sensor on to the holder. Start image capturing in CliniView by pressing the Start intraoral image capturing button. Position the sensor in the patients mouth. The sensor unit can be either on patients chest or with the magnetic mounting on the side of the x-ray unit tube head. Position the Intraoral x-ray unit as appropriate. POWER SWITCH NOTE!
Make sure that the device status indicator illuminates green before making the exposure. 6 Make the exposure by pressing the exposure button of the x-ray unit. Blinking status indicator on the device indicates image transfer. NOTE!
If several images are captured in series, do not switch the sensor off between the exposures. The auto power off will turn the sensor off, if the sensor is not used approximately in 10 minutes. 7 After the image capturing click Abort image capturing button in CliniView. d e v 17 o r p A p Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 2 Capturing intraoral images200150 rev 3Instrumentarium Dental172.6TAKING 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.1Start CliniView software and select a patient2Switch on the sensor by pressing the sensor power switch.3Protect the sensor with a hygienic cover and place the sensor onto the holder.4Start image capturing in CliniView by pressingthe Start intraoral image capturing button.5Position the sensor in the patients mouth. Thesensor unit can be either on patients 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.6Make 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.7After the image capturing click Abort image capturing button inCliniView.POWER SWITCH 2 Capturing intraoral images 8 When capturing is finished switch the sensor off, remove disposable covers and disinfect the sensor if necessary. WARNING!
During the exposure cycle radiation the control protection guidelines must be observed. WARNING!
Minimize the number of running programs before image capturing to ensure the necessary operating system resources for the process. 9 Before unplugging the USB cable, click the Unplug or eject hardware icon on the desktop. Choose Sigma M and then click OK. Safely remove hardware icon on the toolbar, Sigma M = X-
ray device. 2.7 RECHARGING THE BATTERY The battery is recharged with the charger supplied with the device. More than 200 image captures can be made with a fully charged fresh battery. Low battery status is indicated with a flashing orange LED. A few images can still be taken to complete the patient until the orange LED starts flashing fast. Fast flashing indicates critically low battery and image capturing is no more recommended. Charge the empty battery by first plugging the charger cable in to the sensor unit, and then plugging in to the mains. Charging takes about 2 hours and it is indicated with an orange LED that switches off when charging is complete. The device cannot be used when the charger is connected. WARNING!
Charging with equipment other than the original Sigma M charger may cause heat generation or cell leakage. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 18 A p o r p d e v 200150 rev 3 2 Capturing intraoral images18Instrumentarium Dental200150 rev 38When 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.9Before 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.2.7RECHARGING 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 images 2.8 RECOMMENDED EXPOSURE TIMES The table below provides guidelines for exposure times for an average DC generator at 70 kV and 7 mA. These values might need to be adjusted for specific generator characteristics (kV, mA). 9 9 12 Adult Adult Child Child 12 0,100 0,200 0,050 0,100 0,100 0,200 0,050 0,100 0,160 0,320 0,080 0,160 0,100 0,200 0,050 0,100 0,100 0,200 0,050 0,100 0,125 0,250 0,063 0,125 0,125 0,250 0,063 0,125 70 kV SSD Maxillary Incisor Maxillary Cuspid Maxillary Molar Mandibular Incisor Mandibular Cuspid Mandibular Molar Bitewing NOTE!
The selected time varies as the square of the distance. The dose should be increased if the distance from the sensor to the focal spot increases. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 19 2 Capturing intraoral images200150 rev 3Instrumentarium Dental192.8RECOMMENDED 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 kVAdultAdultChildChildSSD912912Maxillary Incisor0,1000,2000,0500,100Maxillary Cuspid0,1000,2000,0500,100Maxillary Molar0,1600,3200,0800,160Mandibular Incisor0,1000,2000,0500,100Mandibular Cuspid0,1000,2000,0500,100Mandibular Molar0,1250,2500,0630,125Bitewing0,1250,2500,0630,125 2 Capturing intraoral images Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 20 A p o r p d e v 200150 rev 3 2 Capturing intraoral images20Instrumentarium Dental200150 rev 3 3 Care instructions 3 Care instructions The user must perform the following inspections monthly:
Visually check that all visible labels are intact and legible Check Sigma M sensor cable(s) for wear and damages Inspect a test image for sensor defect NOTE!
The sensor unit must not be opened or repaired by the user. There are no user serviceable parts in the equipment. In case of malfunction always contact your dealer. 3.1 CLEANING THE SIGMA UNIT The Sigma M sensor unit contains sophisticated electronics. Treat the device with care. Use a cloth moistened in mild cleaning solution
(soap) or mild disinfectant to clean the Sigma M unit. Do not let any water or cleaning fluid to enter the device. Always follow the instructions of the cleaning agent. Use a new disposable hygienic cover for every sensor usage. If required the sensor can be immersed in disinfectant solution. Follow the disinfectant instructions carefully. However immersion should not exceed 12 hours. Be carefull not to let any disinfectant to enter the sensor unit. Do not use aggressive chemicals that may damage the sensor (i.e. hypochlorite or other bleaching chemicals). As a guideline the sensors withstand CIDEX (glutaraldehyde 2,2 - 2,6% and inert components) disinfecting solution. WARNING!
DO NOT:
- Sterilize the sensor using autoclave or an UV oven
- Immersion in bleach or alcohol content solution
- Clean the sensor using in-appropriate instruments Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 21 3 Care instructions200150 rev 3Instrumentarium Dental213Care instructionsThe user must perform the following inspections monthly:Visually check that all visible labels are intact and legibleCheck Sigma M sensor cable(s) for wear and damagesInspect 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.3.1CLEANING 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 instruments 3 Care instructions 3.2 HANDLING THE DEVICE WARNING!
DO NOT:
- Sterilize the sensor using autoclave or an UV oven
- Immersion in bleach or alcohol content solution
- Clean the sensor using in-appropriate instruments
- Pinch or bite sensor or cable
- Pull or bend cable with force
- Unplug charger or USB cable by pulling cable out
- Remove hygienic cover by pulling the cable
- Let sensor fall down
- Touch the connector contacts by hand
- Open sensor unit covers (except battery cover)
- Do not touch open connectors by hand, to avoid malfunctions due to electrostatic discharge
- Do not expose the device to flammable vapour or anesthesia gas. Use the sensor with a proper sensor holder Make sure the sensor never strikes a hard surface. Arrange sensor cable smoothly in its storage place when not in use Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 22 A p o r p d e v 200150 rev 3 3 Care instructions22Instrumentarium Dental200150 rev 33.2HANDLING 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 holderMake sure the sensor never strikes a hard surface.Arrange sensor cable smoothly in its storage place when not inuse
4 Trouble shooting 4 Trouble shooting 4.1 DIAGNOSING IMAGE QUALITY PROBLEMS High quality images with sharp contrast and fine details give optimum diagnostic information. Images of lesser quality are usually a result of one or more common problems, which are discussed here. NOTE!
If using the system in an extremely high electromagnetic environment, some interference in image quality may occur. PROBLEM POSSIBLE CAUSE REMEDY Images are too grainy and light 1 Exposure factors
(kV, mA, s) used are too low 1 Increase exposure factors (see ch 2.8 recommended exposure times) 2 Image adjustments have not been performed 3 Incorrect integration time or generator type
(AC/DC) Images are too dark 1 Exposure factors used are too high Lack of image contrast 2 Image adjustments have not been performed 1 Image adjustments have not been performed 2 Exposure factors
(kV, mA, s) used are not optimal 2 Adjust the image brightness, contrast and gamma using CliniView software 3 Set the generator type and the integration time for AC generator in CliniView 1 Decrease exposure factors 2 Adjust the image brightness, contrast and gamma using CliniView software 1 Adjust the image contrast using CliniView software 2 Increase exposure factors (see ch 2.8 recommended exposure times) Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 23 4 Trouble shooting200150 rev 3Instrumentarium Dental234Trouble shooting4.1DIAGNOSING 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.PROBLEMPOSSIBLE CAUSEREMEDYImages are too grainy and light1Exposure factors (kV, mA, s) used are too low2Image adjustments have not been performed3Incorrect integration time or generator type (AC/DC)1Increase exposure factors (see ch 2.8 recommended exposure times)2Adjust the image brightness, contrast and gamma using CliniView software3Set the generator type and the integration time for AC generator in CliniViewImages are too dark1Exposure factors used are too high2Image adjustments have not been performed1Decrease exposure factors2Adjust the image brightness, contrast and gamma using CliniView softwareLack of image contrast1Image adjustments have not been performed2Exposure factors (kV, mA, s) used are not optimal1Adjust the image contrast using CliniView software2Increase exposure factors (see ch 2.8 recommended exposure times) 4 Trouble shooting PROBLEM POSSIBLE CAUSE REMEDY Images are blurred 1 The patient moved 2 The X-ray source moved 3 Incorrect integration time 1 Prevent patient movement 2 Prevent X-ray unit movement or have the unit serviced 3 Set the integration time in CliniView to be longer than the exposure time Images are burned out 1 Excessive exposure time 1 Set shorter exposure time 2 Change a long cone on the X-ray unit 4.2 DIAGNOSING EQUIPMENT SPECIFIC PROBLEMS PROBLEM POSSIBLE CAUSE REMEDY Sensor cannot be powered 1 The battery is empty Image capturing icons are missing 2 The battery is not inside the electronics 1 Sigma M is not selected as an installed device in CliniView 2 The patient is not selected in CliniView 1 Recharge the battery 2 Insert the battery 1 Select Sigma M as an installed device from Tools menu in CliniView 2 Select the patient Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 24 A p o r p d e v 200150 rev 3 4 Trouble shooting24Instrumentarium Dental200150 rev 34.2DIAGNOSING EQUIPMENT SPECIFIC PROBLEMSImages are blurred1The patient moved2The X-ray source moved3Incorrect integration time1Prevent patient movement2Prevent X-ray unit movement or have the unit serviced3Set the integration time in CliniView to be longer than the exposure timeImages are burned out1Excessive exposure time1Set shorter exposure time 2Change a long cone on the X-ray unitPROBLEMPOSSIBLE CAUSEREMEDYSensor cannot be powered1The battery is empty2The battery is not inside the electronics1Recharge the battery2Insert the batteryImage capturing icons are missing1Sigma M is not selected as an installed device in CliniView2The patient is not selected in CliniView1Select Sigma M as an installed device from Tools menu in CliniView2Select the patientPROBLEMPOSSIBLE CAUSEREMEDY PROBLEM POSSIBLE CAUSE REMEDY 4 Trouble shooting Image capturing cannot be started 1 The battery is empty (The battery status indicator is blinking) 1 Recharge the battery 2 The sensor is not powered 2 Power up the sensor 3 The wireless network is not available 3 Refer to installation manual or contact IT support 4 The gainfile is not installed 4 Use Gain Installer to install the gainfile 5 Used sensor is not set as default CliniView cannot find the sensor /
Sensor is not ready for the image capturing 1 Sigma M is off 2 Wrong sensor switched on 3 WLAN network not set up 4 Another WLAN network is in use 5 WLAN network is down because:
Access point not connected Access point not powered LAN cable not connected 6 WLAN settings are incorrect 7 Charger is connected 5 Set the used sensor as a default in Tools menu in CliniView 1 Switch on the sensor 2 Switch on the sensor assigned to the workstation 3 Set up the wireless network according to the installation manual 4 Choose a WLAN network used for Sigma M 5 Connect USB dongle, Power access point, Connect LAN cable information network or More from administrator adapter manuafacturer 6 Check SSID, IP address and encryption 7 Disconnect the charger Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 25 4 Trouble shooting200150 rev 3Instrumentarium Dental25Image capturing cannot be started1The battery is empty (The battery status indicator is blinking)2The sensor is not powered3The wireless network is not available4The gainfile is not installed5Used sensor is not set as default1Recharge the battery2Power up the sensor3Refer to installation manual or contact IT support4Use Gain Installer to install the gainfile5Set the used sensor as a default in Tools menu in CliniViewCliniView cannot find the sensor / Sensor is not ready for the image capturing1Sigma M is off2Wrong sensor switched on3WLAN network not set up4Another WLAN network is in use5WLAN network is down because:Access pointnot connectedAccess pointnot poweredLAN cable notconnected6WLAN settings are incorrect7Charger is connected1Switch on the sensor2Switch on the sensor assigned to the workstation3Set up the wireless network according to the installation manual4Choose a WLAN network used for Sigma M5Connect USB dongle, Power access point, Connect LAN cableMore informationfrom networkadministrator oradapter manuafacturer6Check SSID, IP address and encryption7Disconnect the chargerPROBLEMPOSSIBLE CAUSEREMEDY 4 Trouble shooting PROBLEM POSSIBLE CAUSE REMEDY Charging the battery does not start / red battery status indicator illuminates 1 Wrong charger used 2 Charger not plugged to the mains Image capturing icon cannot be activated Image capturing fails (image transfer does not start after the exposure) Image transfer fails (image transfer starts after the exposure, but the image does not appear on the screen) 1 Use only the charger accompanied with a sensor 2 Plug the charger to the mains 1 Select the patient 2 Select the correct Sigma M sensor type in CV installed devices list 3 Click Select sensor and assign the sensor 4 Install gain file 1 Patient not selected 2 Sigma M not selected in CV installed devices list 3 Sensor is not preselected 4 Gain file not installed 1 Unactivated sensor has been exposed 1 Retake an image with an activated sensor 1 Network error 1 Reload the image by restarting image capturing mode in CliniView WARNING Do not shut off the sensor. not connect USB cable. Do 2 Reset the Access Point Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 26 A p o r p d e v 200150 rev 3 4 Trouble shooting26Instrumentarium Dental200150 rev 3Charging the battery does not start / red battery status indicator illuminates1Wrong charger used2Charger not plugged to the mains1Use only the charger accompanied with a sensor2Plug the charger to the mainsImage capturing icon cannot be activated1Patient not selected2Sigma M not selected in CV installed devices list3Sensor is not preselected4Gain file not installed1Select the patient2Select the correct Sigma M sensor type in CV installed devices list3Click Select sensor and assign the sensor4Install gain fileImage capturing fails (image transfer does not start after the exposure)1Unactivated sensor has been exposed1Retake an image with an activated sensorImage transfer fails (image transfer starts after the exposure, but the image does not appear on the screen)1Network error1Reload the image by restarting image capturing mode in CliniViewWARNINGDo not shut off thesensor. Do notconnect USB cable.2Reset the Access PointPROBLEMPOSSIBLE CAUSEREMEDY 5 General information 5 General information 5.1 MANUFACTURERS LIABILITY When installing the Sigma M system it is important to observe all warnings and precautions described in this manual. As a manufacturer we can only assume liability for safe and reliable operation of the Sigma M system when:
PC installation was performed according to manuals supplied with the PC CliniView PC software is installed and used according to the Installation & User Manual for CliniView Software. Sigma M system is installed and used according to the Installation & User Manual for Sigma M system Maintenance and repairs are performed by a qualified Sigma M Dealer and Original or authorized replacement parts are used. If service on the equipment is performed, a work order describing the type and extent of repair must be provided by the service technician. This must contain information of changes of nominal data or work range performed. The work order must furthermore indicate the date of repair, the name of the company concerned and a valid signature. The user should keep this Service Report for future reference. If you have any problems or difficulties when capturing images, please refer to troubleshooting in the user manual. Please find the electromagnetic compatibility tables according to IEC 60601-1-1-2 Ed 2 in this Sigma M user manual. Use only USB cable delivered with the device to ensure proper operation according to specification. 5.2 MARKINGS AND GRAPHICS SYMBOLS The following markings are used in this manual:
NOTE!
Contains useful information for the reader about the unit and its use. CAUTION!
Contains important instructions. If these instructions are not observed, malfunction of the unit or damage to the unit or other property may occur. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 27 5 General information200150 rev 3Instrumentarium Dental275General information5.1MANUFACTURERS 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 PCCliniView 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 systemMaintenance 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.5.2MARKINGS 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 information WARNING!
Contains warnings and instructions about the safety of the unit. If these warnings are not respected, serious risks and injury may be caused to the patient and operator. The following symbols are used in the Sigma M device and in the manuals:
Attention, consult accompanying documents. Contains warnings and instructions about the safety of the unit. If these warnings are not observed, serious risks and injury may be caused to the patient and operator. If the unit has CE-marking it is CE-marked according to the Medical Device Directive 93/42/EEC. USB connection DC connector Indoor, dry location use only Power Non-ionizing radiation IP21 The device complies with Part 15 of the FCC Rules. 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. in instructions The information necessary for the installation and use of the Sigma M system. As manufacturer we strongly recommend that you read this manual before installation and use. this manual contain essential Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 28 A p o r p d e v 200150 rev 3 5 General information28Instrumentarium Dental200150 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. IP21The degree of protection provided by the sensor unit enclosure against solid objects greater than 12.5 mm in diameter and against vertically dripping water.This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. The following abbreviations may be used in this manual:
5 General information PC HD Hz MHz CPU RAM MB GB CD-R Personal computer Hard disk Herz; cycles per second Millions of hertz Central processing unit (computer) Random access memory Mega bytes Giga bytes Compact disc (recordable) CD-RW Compact disc (re-writable) DVD-RW Digital Versatile Disc (re-writable) HDD PCI LAN USB MAC WLAN Wi-Fi High density drive Peripheral Component Interconnect Local Area Network Universal Serial Bus Medium Access Control Wireless local area network Wireless network compliant with IEEE802.11 Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 29 5 General information200150 rev 3Instrumentarium Dental29The following abbreviations may be used in this manual:PCPersonal computerHDHard diskHzHerz; cycles per secondMHzMillions of hertzCPUCentral processing unit (computer)RAMRandom access memoryMBMega bytesGBGiga bytesCD-RCompact disc (recordable)CD-RWCompact disc (re-writable)DVD-RWDigital Versatile Disc (re-writable)HDDHigh density drivePCIPeripheral Component InterconnectLANLocal Area NetworkUSBUniversal Serial BusMACMedium Access ControlWLANWireless local area networkWi-FiWireless network compliant with IEEE802.11 5 General information 5.3 MAIN LABEL The sensor model Sigma M is available in two product type. The exact type of the device is shown on the main label. Fig 5.1. Label on CE-marked device MAC is a unique MAC-address of the internal WLAN terminal. Type S1 S2 Description Part number Sensor size 1 Sensor size 2 900003 900004 The main label with the serial number of the product of the device is attached to the battery cover. The battery cover must not be replaced by an unauthorized person. Contact your local dealer for servicing a damaged cover if needed. 5.4 MANUALS The following manuals and documents are shipped with the Sigma M system:
Sigma M User Quick Guide Sigma M Installation Manual Sigma M User Manual CliniView User Manual CliniView Installation Manual 5.5 DISPOSAL At the end of useful working life of the device, its spare and replacement parts and accessories make sure that you follow all local, national and international regulations regarding the correct and safe disposal and/or recycling of the device, its spare and replacement parts and accessories. The device and its spare and replacement parts and accessories may include parts that are made of or include materials that are non-
environmentally friendly or hazardous. These parts must be disposed of in accordance with all local, national and international regulations regarding the disposal of non-environmentally friendly or hazardous materials. The following hazardous materials and substances can be found in the device its spare and replacement parts and assemblies:
Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 30 o r p d e v 200150 rev 3 A p 5 General information30Instrumentarium Dental200150 rev 35.3MAIN 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.5.4MANUALSThe following manuals and documents are shipped with the Sigma Msystem:Sigma M User Quick GuideSigma M Installation ManualSigma M User ManualCliniView User ManualCliniView Installation Manual5.5DISPOSALAt 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:TypeDescriptionPart numberS1Sensor size 1900003S2Sensor size 2900004
5 General information lead (Pb): sensor, circuit board The locations of all the spare and replacement parts and assemblies listed above can be found in the service and/or installation manual supplied with the device. 5.6 WARNINGS Minimize the number of running programs before image capturing to ensure the necessary operating system resources for the process. Computer should only be connected to grounded outlet Do not forcefully bend sensor cables. Avoid mechanical wear and stress (pulling the cable) Use only the power supply specified by the manufacturer Make sure that the Ready LED illuminates before making an exposure. Don't sterilize the sensor using autoclave or UV oven Use a disposable hygienic cover or disinfect the sensor after every patient The battery is harmful to the environment and so it must be disposed of in accordance with local regulations. The electronics box must not be opened or repaired by the user Do not allow water or other cleaning liquids to enter the electronics Connect the system only to a PC conforming with IEC60950 or IEC60601-1 5.7 NOTICE OF WIRELESS LAN USAGE WLAN operation is based on emitting and receiving RF energy. This equipment complies with European R & TTE directives, and may be operated without a licence in Europe (ETSI). The declaration of conformity can be consulted at Instrumentarium Dental. Although this and other use environment devices comply with CISPR requirements for RF emissions, interference may still occur. Monitor the performance of the wireless link. If it behaves in a strange or unexpected way that may endanger patient safety, use the USB connecting cable until the problem is resolved. Hereby, Instrumentarium Dental, declares that this Sigma M -
sensor is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 31 5 General information200150 rev 3Instrumentarium Dental31lead (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.5.6WARNINGSMinimize the number of running programs before image capturingto ensure the necessary operating system resources for theprocess.Computer should only be connected to grounded outletDo not forcefully bend sensor cables. Avoid mechanical wear andstress (pulling the cable)Use only the power supply specified by the manufacturerMake sure that the Ready LED illuminates before making anexposure.Don't sterilize the sensor using autoclave or UV ovenUse a disposable hygienic cover or disinfect the sensor afterevery patientThe 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 userDo not allow water or other cleaning liquids to enter theelectronicsConnect the system only to a PC conforming with IEC60950 orIEC60601-15.7NOTICE 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 information 5.8 FCC CERTIFICATION This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1 2 This device may not cause harmful interference This device must accept any interference received, including interference that may cause undesired operation. Sigma M sensor Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. NOTE!
This equipment has been tested and found to comply with the limits for Class B digital device, pursuant to Part 15 or the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- reorient or relocate the receiving antenna
- increase the separation between the equipment and receiver
- connect the equipment into an outlet on a circuit different from that to which the receiver is connected
- consult the dealer or an experienced radio/TV technician for help Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 32 A p o r p d e v 200150 rev 3 5 General information32Instrumentarium Dental200150 rev 35.8FCC CERTIFICATIONThis device complies with Part 15 of the FCC Rules. Operation issubject to the following two conditions:1This device may not cause harmful interference2This 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 users 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 sensor 6 Technical specifications 6 Technical specifications 6.1 GENERAL Manufacturers quality system:
Electrical and Mechanical safety:
ISO 9001, ISO 13485 Medical Equipment with respect to electrical shock, fire and mechanical hazards only in accordance with UL60601, CAN/CSA C22.2 no 601.1 According to IEC 60601-1, CE models marked according to the Medical Device Directive 93/42/EEC (Device classification: II b), Mobile sensor unit that is IEEE 802.11b (WLAN) compliant Patient connection (sensor): BF-type Sensor technology:
CMOS Active Pixel technology
(CMOS APS) IMAGE QUALITY Resolution:
Grayscale:
Holders:
SOFTWARE MAIN FEATURES Operating system:
Operating software:
Full Mouth Series:
File sizes:
X-ray shield in the sensor:
D 6.2 DIMENSIONS 26.3 lp/mm (theoretical) 4096 gray levels. A full set of color coded KerrHawe and Sigma M sensor holders, with easy instructions, for comfortable and accurate positioning. Windows 2000 or XP (SP2) CliniView version 6.4 or later FMS, user defined 3,17 MB, uncompressed file,Sensor size1 4,96 MB, uncompressed file,Sensor size2 Lead (Pb) Outer dimensions:
Active image area:
Sensor unit:
Sensor size 1:
Sensor size 2:
Sensor size 1:
Sensor size 2:
102 x 60 x 22 mm 26 x 37 mm 31 x 44 mm 30.02 x 19,95 mm2 36,48 x 25,84 mm2 e v o r d 33 Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p p 6 Technical specifications200150 rev 3Instrumentarium Dental336Technical specifications6.1GENERALDManufacturers 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)6.2DIMENSIONSOuter 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 mm2 6 Technical specifications Sensor shape:
Four rounded corners, two corners with greater radius for better patient comfort in Sensor size 2. PIXEL SIZE Sensor size 1:
Sensor size 2:
19 m x 19 m 19 m x 19 m 1580 x 1050 pixels 1916 x 1358 pixels Sensor cable length Sensor size 1:
Sensor size 2:
40 cm 40 cm 6.3 SENSOR UNIT Sensor unit box:
PC connection:
USB:
USB cable length:
General applied part
(sensor):
Battery type:
Battery capacity:
Vertically or horizontally mounted on desktop or wall mounted. A Sigma M Sensor that is connected to the sensor unit can be shared between rooms without need to switch off the PC. 802.11b/g 2.4 GHz Access Point or USB USB 2.0 Full speed, mini USB-B port connector, 500 mA. maximum 3 meters (9,8 feet), ferrite required. BF type Rechargable lithium Polymer battery 1000 mAh (correspond approx 200 image capture). (Battery life expectancy:
500 cycles C/2, 20C) in WLAN use. External power supply: DC connector, 6V, center pin positive 6.4 RF EXPOSURE INFO WLAN:
Frequency:
Output power:
Separation:
According to IEEE 802.11b 2400 MHz - 2483 MHz max 0,25 W (FCC) max 0,1 W (ETSI) Keep the sensor unit min. 20 cm away from the patient Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 34 A p o r p d e v 200150 rev 3 6 Technical specifications34Instrumentarium Dental200150 rev 3Sensor shape:Four rounded corners, two corners with greater radius for better patient comfort in Sensor size 2.PIXEL SIZESensor size 1:19 m x 19 m1580 x 1050 pixelsSensor size 2:19 m x 19 m1916 x 1358 pixelsSensor cable lengthSensor size 1:40 cmSensor size 2:40 cm6.3SENSOR 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, 20C) in WLAN use.External power supply:DC connector, 6V, center pin positive6.4RF 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 patient 6 Technical specifications 6.5 AMBIENT CONDITIONS The Sigma M unit Transportation and storage temperature:
Operating temperature:
Relative humidity (storage):
Water tightness:
The battery Charge Temperature Storage Temperature and time to prevent self discharge Materials Sensor cover Sensor cable Hygienic cover
-40...+60C (-40F...+158F), note battery discharge during long storage and high temperature
+10...+40C (+50F...+104F) 10-93%
IP67 (sensor) IP21 (sensor unit) Charge:
0...+45C (+32F...+113F) 1 Year at
-20...+20C (-4F...+68F) 3 Month at
-20...+45C (-4F...+113F) 1 Month at
-20...+60C (-4F...+140F) PA PUR Ethylene Methyl Acrylate Copolymer 6.6 IMAGE ACQUISITION SYSTEM REQUIREMENTS The Sigma M acquisition system consists of Sigma M sensor and PC hardware. Sigma M sensor is a medical device. WARNING!
If a IEC 60950-compliant (non-medical) PC is used, it must not be brought in to the patient environment (see Sigma M installation manual for details). WARNING!
Do not bring open (unconnected) USB cable to the patient area. If the sensor is used with USB cable in the patient area, the user must make sure that system leakage current does not exceed IEC/ISO 60601-1-1 limits (see Sigma M installation manual for details). Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p e v o r p d 35 6 Technical specifications200150 rev 3Instrumentarium Dental356.6IMAGE 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).6.5AMBIENT CONDITIONSThe Sigma M unitTransportation and storage temperature:-40...+60C (-40F...+158F), note battery discharge during long storage and high temperatureOperating temperature:+10...+40C (+50F...+104F)Relative humidity (storage):10-93%Water tightness:IP67 (sensor)IP21 (sensor unit)The batteryCharge TemperatureCharge: 0...+45C (+32F...+113F)Storage Temperature and time to prevent self discharge1 Year at-20...+20C (-4F...+68F)3 Month at-20...+45C (-4F...+113F) 1 Month at-20...+60C (-4F...+140F)MaterialsSensor coverPASensor cablePURHygienic coverEthylene Methyl Acrylate Copolymer 6 Technical specifications Sigma M IMAGE ACQUISITION SYSTEM REQUIREMENTS Electrical safety Processor Hard disk CD-ROM Keyboard Mouse USB port IEC 60950 for office use or IEC/ISO 60601-1 (medical PC) Pentium 600MHz or better (Windows 2000) Pentium 600MHz or better (Windows XP) 10 GB Yes Yes Yes Yes Accessories Audiocard and speakers optional Operating system Windows 2000 Windows XP (SP2) See Microsoft Windows System Requirements Main memory (RAM) Windows 2000 and XP: 256 MB or more Monitor Archive 15 or bigger CD-R DAT Iomega Jazz MOD WLAN network adapter IEEE 802.11 b compatible (built in, USB, access point or equivalent) 6.7 ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES These Electromagnetic Compatibility tables according to IEC 60601-1-2 Ed 2 in chapter 7.5 consists of:
WARNING!
When used Sigma M adjacent to other equipment such configuration should be carefully observed that electromagnetic interference (EMI) does not degrade performance. to ensure The use of Sigma M attached to Instrumentarium Dental Focus x-ray, as presented in this user manual, has been verified by the manufacturer. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 36 A p o r p d e v 200150 rev 3 6 Technical specifications36Instrumentarium Dental200150 rev 36.7ELECTROMAGNETIC 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 safetyIEC 60950 for office useor IEC/ISO 60601-1 (medical PC)ProcessorPentium 600MHz or better (Windows 2000)Pentium 600MHz or better (Windows XP)Hard disk10 GBCD-ROMYesKeyboardYesMouseYesUSB portYesAccessoriesAudiocard and speakers optionalOperating systemWindows 2000Windows XP (SP2)See Microsoft Windows System RequirementsMain memory (RAM)Windows 2000 and XP: 256 MB or moreMonitor15 or biggerArchiveCD-RDATIomegaJazzMODWLAN network adapterIEEE 802.11 b compatible (built in, USB, access point or equivalent) 6 Technical specifications WARNING!
USE LIMITATION: External components: The use of accessories, transducers, and cables other than those specified may result in degraded the EQUIPMENT and/or SYSTEM. ELECTROMAGNETIC COMPATIBILITY of WARNING!
Portable and mobile RF communications equipment can affect the system. The Sigma is suitable for use in the specified electromagnetic environment. The purchaser or user of the Sigma should assure that it is used in an electromagnetic environment as described below:
Emissions Test Compliance Electromagnetic Environment Radio-Frequency Group 2 Emissions CISPR11 The Sigma M must emit electromagnetic energy in order to perform its intended function. Nerby electronic equipment may be affected. Radio-Frequency Class B Emissions CISPR11 Harmonic emissions IEC 61000-3-2 Class A IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Complies The Sigma is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 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. 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. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 37 6 Technical specifications200150 rev 3Instrumentarium Dental37WARNING!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 TestComplianceElectromagnetic EnvironmentRadio-FrequencyEmissionsCISPR11Group 2The Sigma M must emit electromagnetic energy in order to perform its intended function. Nerby electronic equipment may be affected.Radio-FrequencyEmissionsCISPR11Class BThe 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 AThe 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 61000-3-3CompliesThe 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 6.1Electromagnetic emissions IEC 60601-1-2 Ed 2. 6 Technical specifications Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2 Frequency of Transmitter Equation Rated Maximum Output Power of Transmitter (watts) 0.01 0.1 1 10 100 150KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
= d 5,3 V 1
P
= d 5,3 E 1
P
= d 7 E 1
P Separation Distance
(meters) Separation Distance
(meters) Separation Distance
(meters) 0.12 0.37 1.17 3.69 11.67 0.12 0.37 1.17 3.69 11.67 0.23 0.74 2.34 7.38 23.34 Table 6.2 Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2 Ed 2. Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 38 A p o r p d e v 200150 rev 3 6 Technical specifications38Instrumentarium Dental200150 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)0.010.120.120.230.10.370.370.7411.171.172.34103.693.697.3810011.6711.6723.34Table 6.2Recommended 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[1 6 Technical specifications Sigma M is suitable for use in the specified electromagnetic environment. The purchaser or user of Sigma M should assure that it is used in an electromagnetic environment as described below:
Immunity Test IEC 60601-1-2 Test Level Compliance Level Electrostatic discharge (ESD) IEC 61000-4-2 2, 4, 6 kV for contact discharge 2, 4, 8 kV for air discharge 2, 4, 6 kV for contact discharge 2, 4, 8 kV for air discharge 2 kV for power 2 kV for power supply lines supply lines 1 kV for input/output lines 1 kV for input/output lines 1 kV differential 1 kV differential mode 2 kV common mode 2 kV common mode mode
< 5 % UT
(> 95 % dip in UT) for 0,5 cycle 40 % UT
(60 % dip in UT) for 5 cycles 70 % UT
(30 % dip in UT) for 25 cycles
< 5 % UT
(> 95 % dip in UT)
< 5 % UT
(> 95 % dip in UT) for 0,5 cycle 40 % UT
(60 % dip in UT) for 5 cycles 70 % UT
(30 % dip in UT) for 25 cycles
< 5 % UT
(> 95 % dip in UT) 3 A/m 3 A/m Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 Electromagnetic Environment Floors are wood, concrete, or ceramic tile, or floors are covered with synthetic material and the relative humidity is at least 30 percent. Mains power quality is that of a typical commercial and/or hospital environment Mains power quality is that of a typical commercial and/or hospital environment. 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 magnetic fields are at levels characteristic of a typical location in a typical commercial and/or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. Table 6.3 Electromagnetic immunity IEC 60601-1-2 Ed2 Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 39 6 Technical specifications200150 rev 3Instrumentarium Dental39Sigma 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 TestIEC 60601-1-2Test LevelComplianceLevelElectromagnetic 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/m3 A/mPower frequency magnetic fields are at levels characteristic of a typical location in a typical commercial and/or hospital environment.NOTE: UT is the a.c. mains voltage prior to application of the test level.Table 6.3 Electromagnetic immunity IEC 60601-1-2 Ed2 6 Technical specifications Sigma M is suitable for use in the specified electromagnetic environment. The purchaser or user of Sigma M should assure that it is used in an electromagnetic environment as described below:
Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment Portable and mobile RF communications equipment are used no closer to any part of Sigma M, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Recommended Separation Distance:
Conducted RF IEC 61000-4-6 3 V150 kHz to80 MHz
[ V1 ] 3 V Radiated RFIEC 61000-4-3 3 V/m80 MHz to2,5 GHz
[ E1 ] 3 V/m
= d 5,3 V 1
P
= d 5,3 E 1
P
= d 7 E 1
P 80 MHz to 800 MHz 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,* are less than the compliance level in each frequency range.** Interference may occur in the vicinity of equipment marked with the following symbol:
*Field strengths from fixed transmitters, such as base stations for cellular telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be estimated accurately. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be performed. If the measured field strength exceeds the RF compliance level above, observe Sigma M to verify normal operation in each use location. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating Sigma M.
**Over the frequency range 150 kHz to 80 MHz, field strengths are less than [V1] V/m. The Recommended Separation Distances are listed on page 21. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Table 6.4 RF immunity of non-life-support equipment or system IEC 60601-1-2 Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 40 A p o r p d e v 200150 rev 3 6 Technical specifications40Instrumentarium Dental200150 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:ImmunityTestIEC60601-1-2Test LevelComplianceLevelElectromagneticEnvironmentConducted 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[1 7 Appendix 1, Sigma M products and accessories 7 Appendix 1, Sigma M products and accessories A Sigma M system (with the exception of the PC) is assembled using the following parts:
Part no. 900003 900004 Products Description Sigma M sensor size 1 (Type S1):
USB electronics with battery Sigma M charger Wall mount set USB-cable, 3m CliniView software CD Manuals Sensor ID sticker Mounting magnet Sigma M sensor size 2 (Type S2):
USB electronics with battery Sigma M charger Wall mount set USB-cable, 3m CliniView software CD Manuals Sensor ID sticker Mounting magnet The following accessories are approved parts:
Part no. 55042 200382 200383 5169795 5169703 200245 200162 Accessories Description Sigma M hygienic covers (500 pcs) Sigma M Charger, EUR Sigma M Charger, USA Rechargable Battery Mounting Magnet Wall Mount set Sigma M Sensor holder starter kit Size 1
- Bitewing holder 1 pc
- Posterior holder (UR/LL) 1 pc
- Posterior holder (UL/LR) 1 pc
- Periapical holder (UR/LL) 1pc
- Periapical holder (UL/LR) 1 pc
- Endo holder (UR/LL) 1 pc
- Endo holder (UL/LR) 1 pc
- Positioning ring 1 pc Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 200150 rev 3 A p o r p d e v 41 7 Appendix 1, Sigma M products and accessories200150 rev 3Instrumentarium Dental417Appendix 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.Description900003Sigma M sensor size 1 (Type S1):USB electronics with batterySigma M chargerWall mount setUSB-cable, 3mCliniView software CDManualsSensor ID stickerMounting magnet900004Sigma M sensor size 2 (Type S2):USB electronics with batterySigma M chargerWall mount setUSB-cable, 3mCliniView software CDManualsSensor ID stickerMounting magnetAccessoriesPart no.Description55042Sigma M hygienic covers (500 pcs)200382Sigma M Charger, EUR200383Sigma M Charger, USA5169795Rechargable Battery5169703Mounting Magnet200245Wall Mount set200162Sigma M Sensor holder starter kit Size 1- Bitewing holder 1 pc- Posterior holder (UR/LL) 1 pc- Posterior holder (UL/LR) 1 pc- Periapical holder (UR/LL) 1pc- Periapical holder (UL/LR) 1 pc- Endo holder (UR/LL) 1 pc- Endo holder (UL/LR) 1 pc- Positioning ring 1 pc 7 Appendix 1, Sigma M products and accessories Part no. 200163 200333 200335 200337 200338 200334 200339 200340 200330 200331 200332 Accessories Description Sigma M Sensor Holder Starter Kit Size 2
- Bitewing holder 1 pc
- Posterior holder (UR/LL) 1 pc
- Posterior holder (UL/LR) 1 pc
- Periapical holder (UR/LL) 1pc
- Periapical holder (UL/LR) 1 pc
- Endo holder (UR/LL) 1 pc
- Endo holder (UL/LR) 1 pc
- Positioning ring 1 pc Bitewing Refill S1 Refill Pack, 10 pcs Posterior S1 Refill pack, 10 pcs Periapical S1 Refill Pack, 10 pcs Endo S1 Refill Pack, 10 pcs Positioning ring Refill Pack, 5 pcs Bitewing S2 Refill Pack, 10 pcs Posterior S2 Refill pack, 10 pcs Super-Bite Senso Holders (KerrHawe)
- Super-Bite Senso Anterior 2 pcs
- Super-Bite Senso Posterior 2 pcs Kwik-Bite Senso Holders (KerrHawe)
- Kwik-Bite Senso 4 pcs Endo-Bite Senso Holders (KerrHawe)
- Endo-Bite Senso Anterior 2 pcs
- Endo-Bite Senso Posterior 2 pcs Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 Instrumentarium Dental 42 A p o r p d e v 200150 rev 3 7 Appendix 1, Sigma M products and accessories42Instrumentarium Dental200150 rev 3200163Sigma 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 pc200333Bitewing Refill S1 Refill Pack, 10 pcs200335Posterior S1 Refill pack, 10 pcs200337Periapical S1 Refill Pack, 10 pcs200338Endo S1 Refill Pack, 10 pcs200334Positioning ring Refill Pack, 5 pcs200339Bitewing S2 Refill Pack, 10 pcs200340Posterior S2 Refill pack, 10 pcs200330Super-Bite Senso Holders (KerrHawe)- Super-Bite Senso Anterior 2 pcs- Super-Bite Senso Posterior 2 pcs200331Kwik-Bite Senso Holders (KerrHawe)- Kwik-Bite Senso 4 pcs200332Endo-Bite Senso Holders (KerrHawe)- Endo-Bite Senso Anterior 2 pcs- Endo-Bite Senso Posterior 2 pcsAccessoriesPart no.Description Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 A p d e v o r p Instrumentarium Dental reserves the right to make changes in specification and features shown herein, or discontinue the product described at any time without notice or obligation. Contact your Instrumentarium Dental representative for the most current information. Copyright 04/2007 by PaloDEx Group Oy. All rights reserved. Instrumentarium Dental P.O.Box 20, FI-04301 Tuusula, Finland Tel. +358 45 7882 2000 Fax +358 45 7882 2506 Americas:
Instrumentarium Dental Inc. Milwaukee, Wisconsin, U.S.A. Tel. 800 558 6120 Fax 414 481 8665 Reviewed: Anttila Mika Johannes 02.05.07 09:54:49 Approved: Levlampi Juhani Eemeli 02.05.07 12:02:32 See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31 d e v o r p Sigma M User Manual, English A p 200150 rev 3 Printed in Finland 04/2007 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 8665
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2007-08-06 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2007-08-06
|
||||
1 | Applicant's complete, legal business name |
Instrumentarium Dental, PaloDEx Group Oy
|
||||
1 | FCC Registration Number (FRN) |
0015495369
|
||||
1 | Physical Address |
Nahkelantie 160
|
||||
1 |
64
|
|||||
1 |
Tuusula, N/A FI-04300
|
|||||
1 |
Finland
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
T******@intertek.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
UMJ
|
||||
1 | Equipment Product Code |
SM
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
M**** J****** T******
|
||||
1 | Telephone Number |
+358-******** Extension:
|
||||
1 | Fax Number |
+358-********
|
||||
1 |
m******@palodexgroup.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
PaloDEx Group Oy
|
||||
1 | Name |
M**** A******
|
||||
1 | Physical Address |
Nahklantie 160
|
||||
1 |
64
|
|||||
1 |
Tuusula, FI-04300
|
|||||
1 |
Finland
|
|||||
1 | Telephone Number |
358-4********
|
||||
1 | Fax Number |
358-4********
|
||||
1 |
m******@palodexgroup.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
Instrumentarium Dental Inc.
|
||||
1 | Name |
F****** K********
|
||||
1 | Physical Address |
300 West Edgerton Avenue
|
||||
1 |
Milwaukee, Wisconsin 53207
|
|||||
1 |
United States
|
|||||
1 | Telephone Number |
414-7********
|
||||
1 | Fax Number |
414-4********
|
||||
1 |
F******@Palodexgroup.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Digital Intraoral Sensor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output is peak conducted. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. End-users and installers must be provided with antenna installation and transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Intertek ETL Semko Oy NATLABS
|
||||
1 | Name |
T****** H****
|
||||
1 | Telephone Number |
358-1********
|
||||
1 | Fax Number |
358-2********
|
||||
1 |
t******@intertek.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.2240000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC