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1. NOTE It is strictly mandatory to follow these Care Instructions in order to not void the warranty of the product AN CAUTION As a standard recommendation clean the unit regularly using non agressive mild and commercially available cleaning agents 4 2 CLEANING RECOMMENDATIONS Items and surfaces can be cleaned with a soft cloth moistured with disinfective after every usage N WARNING Always disconnect SmartPad and OP200 D from the mains prior to cleaning or disinfecting the unit N CAUTION Do not allow water or other cleaning liquids to enter the unit as these may cause short circuits or corrosion 4 2 1 Cleaning The purpose of cleaning and rinsing is to remove all adherent visible impurities eg blood protein substances and other debris to reduce the number of particulate and micro organisms and to reduce the amount of pyrogenic and antigenic material Use a cloth moistened in cool to lukewarm soapy water for cleaning the unit and preventing coagulation and thus faciliate the removal of protein substances Then wipe with a cloth moistened in clean water Mild detergent solution can be used Use cleaners or solvents listed as permissible cleaning agents below If you are uncertain of the nature of the cleaning agent do not use it Instrumentarium Dental 39 4 Equipment care Examples of cleaning agents that are permissible or prohibited when cleaning the unit panels Permissible methanol me
2. 2 2 OF G2O0 FIOM ee Ee son l obvia Ete uat 11 2 9 Or COO EE 12 24 RR Ee e Le EE 12 WER A tee TES TO H S I EE 14 2 6 SmartPad Medical Power SPM200 esseeeesseesssseeeeeene nnne 15 2 Sr IVIZOO WINING al e Te EE 16 3 in let Te WI ECHTEN BE 17 el SAGER ERE EEN 17 S ME al Se ee EE 18 320 stalling the Tastenirig Ba ele 18 3 4 Installation of SmartPad display bracket cccceecccseeeeeeeeeeeceeeeeseeeseeeeesseees 20 3 5 Installation of embedded medical computer 21 3 6 Cabling of the embedded medical computer 22 3 7 INANZING INE IMSTAN ANON EE 24 Se Wall MOUNINO E 25 3 9 SmartPad Medical Power SPM200 installation eeseeessss 26 3 10 Changing the line voltage Connechon n 29 9 11 SmartNav INSTA en EE 31 3 12 Repairing SmartNav installation ccccccceecccsseeeeeeeeeseeeeeseeeesseeeeseeeeeseeeeseeseeees 35 3 T9 le neng Eat CT EE 36 4 Eduipment TE 39 dd CAVE ee E T o LTEM 39 4 2 Gleaning recommendations sssr ssec uide ie beum dumme egeta eoe UE cet D ten EEG 39 a2 GI in t D UELLE 39 5 Operating InstEUGllOlnS EE 41 Bel OMN Val VV IMO OW E ETE 41 5 2 MMAGING program SeCUO EE 41 SiO WTO SCCUON EE 44 54A Other Secon S EE 45 509 Redl dime Status OP the BE EE 45 sns sedie c E UU TETTE 46 o Slarting talliNaV EEN 48 5 9 CATING WIM E Lat 48 5 9 Patient POSITIONING ANIMATION etait ioi NEEN ENNEN EENEG ENNEN 49
3. mounting surface and choose the mounting system according to the following examples Mount the unit so that the upper edge of the supporting arm s bracket is approximately 40 inches 1000 mm from the floor 1 Wall The wall and mounting hardware must sustain a force of 350 Ibs 1500N on each wall bracket bolt 2 Specify the sight of the unit and drill suitable holes according to mounting hardware Insert plugs if necessary 3 Fasten the mounting bracket loosely to the wall Level and tighten the wall mounting bracket Repeat the previous steps when installing the SPC200 5 The SPC200 and the SmartPad display must be connected with a grounding wire 200209 rev 3 Instrumentarium Dental 25 3 SmartPad installation A WARNING Connect the grounding wire between the earth ground connector on the computer front panel and the SmartPad display see chapter SPC200 FrontPanel e H Note We recommend that when mounting the SPC200 to a wall the SPC200 is installed so that the ON OFF indicator is visible 3 9 SMARTPAD MEDICAL POWER SPM200 INSTALLATION Connecting the SPM200 power module to SmartPad and an external PC system 26 Instrumentarium Dental 200209 rev3 3 SmartPad installation 1 Place the SPM200 module on a table or use the bottom plate for fixing the module to a wall or to another suitable surface Please note that it is not allowed to place the SPM200 on the floor Mount the unit in such a way that ingre
4. 1 shows the first menu Click the calibrate button to start the screen coordinates configuration P MT 7 Software Control Panel Version 7 10 Main Touch Settings Tools Calibration MT 7 provides a 3 30int calibration for optimum accuracy for your touch display Calibrate h Press th s button to calibrate your touch cres Controller Information Controller Type SC 400 800 Firmware Version 01 05 Touch Screen Status OK Attention the data is absent if the touch screen is not connected correctly Communication Port Close Help About Fig 8 1 Initial menu The calibration procedure starts by pressing with a finger or a stylus on the green point on the screen If the pressing is correct the point becomes red 76 Instrumentarium Dental 200209 rev 3 200209 rev 3 8 Maintenance Touch each target for several seconds and then liftoff Fig 8 2 Step 1 Press on the second point and proceed as in the first step as shown in the fig 10 3 Repeat the same procedure for position three 5 Fig 8 3 OK Touch each target for several seconds and then liftoff Fig 8 4 Step 2 Instrumentarium Dental 77 8 Maintenance Touch each target for several seconds and then liftoff Fig 8 5 Step 3 At this point the following window will appear on the screen if the calibration has gone well During the calibration phase if something goes wrong the p
5. Do not overtighten Grounding cable terminal can also be installed to the grounding point on OP column at this point Install the SmartPad display to the bracket so that the display cables run below the supporting arm Place two sliding ring plates to the cleft between the bracket and the supporting arm One piece per slot CH E bu Hie 3 Instrumentarium Dental 200209 rev 3 200209 rev 3 3 SmartPad installation 3 5 INSTALLATION OF EMBEDDED MEDICAL COMPUTER e NOTE Do not drop washers into the computer while fastening Attach the SPC200 embedded medical grade computer 1 The embedded computer cover plate can be removed if needed by releasing two screws holding the cover 2 Install the counter weight servicing plate on the rear side of the column prior to installing the embedded computer w um 3 Liftand place the embedded computer hanging to the holder pins Pass the SmartPad display cables through the opening on the SPC200 computer Install and tighten the washers and nuts holding the computer e NOTE Do not damage the grounding cable or white colored Z motor cable while installing and fastening the embedded computer Instrumentarium Dental 21 3 SmartPad installation 3 6 CABLING OF THE EMBEDDED MEDICAL COMPUTER Attach the cables to the SPC200 The OP200 column the SPC200 and the supporting arm must be interconnected by a grounding wire 1 Connect the other end of the grou
6. Ed2 70 Instrumentarium Dental 200209 rev 3 7 Technical specifications Orthopantomograph OP200 D with SmartPad accessory is suitable for use in the specified electromagnetic environment The purchaser or user of the Orthopantomograph OP200 D with SmartPad accessory should assure that it is used in an electromagnetic environment as described below Immunity IEC Compliance Electromagnetic Test 60601 1 2 Level Environment Test Level Portable and mobile RF communications equipment are used no closer to any part of Orthopantomograph OP200 D with SmartPad accessory including cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Conducted 3 V150 kHz Recommended Separation Distance RF IEC to80 MHz 3 5 61000 4 6 d P Vi Radiated 3 V m80 E 3 V m RFIEC MHz to2 5 35 d WP 61000 4 3 GHz E i 80 MHz to 800 MHz d WP Ei 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 d Field strengths from fixed transmitters such as base stations for cellular
7. Monitor supporting arm 3 SmartPad touch screen monitor STP200 e NOTE When user s PC is used the embedded medical grade computer is replaced with SmartPad Medical Power SPM200 200209 rev 3 Instrumentarium Dental 2 SmartPad main parts 2 1 EMBEDDED MEDICAL COMPUTER SPC200 4 Top cover 5 Cover plate 6 Base plate 7 Inner case 8 ON OFF indicator 10 Instrumentarium Dental 200209 rev3 200209 rev 3 2 SmartPad main parts 2 2 SPC200 FRONTPANEL 10 19 11 9 re CTD GED MONITOR PWR gt 12Vdc 9 Front panel 10 Earth ground connector 11 Monitor power connector 12 Optical cable connectors RX and TX 13 Link OK LED 14 EEPROM failure LED 15 Supply voltages OK LED 16 Local reset LED 17 VGA connector 18 Two USB connectors 19 1GB Ethernet connector 20 COMI connector 21 LPT connector 22 Keyboard connector 23 Mouse connector 24 Audio in 25 Audio out 26 Microphone Instrumentarium Dental 2 SmartPad main parts 2 3 SPC200 REARPANEL 27 29 2 Rear panel 28 RESET switch 29 Microsoft Windows XP authenticity label 30 AC inlet 31 Main label 2 4 SPC200 CABLING 12 Instrumentarium Dental 200209 rev3 200209 rev 3 2 SmartPad main parts 32 33 34 35 36 37 STP200 USB cable STP200 VGA cable Unshielded CAT5 CAT6 Ethernet Cable for LAN connection STP200 Power cable Optical cable to OP200 D Mains cable Instrumentarium Denta
8. SYSTEM WITHOUT ADEQUATE EXPERTISE IS EXTREMELY DANGEROUS Instrumentarium Dental recommends that all service operations are performed by Instrumentarium Dental authorized service personnel 8 2 MONTHLY INSPECTION BY USER The user must perform monthly the following inspections Visually check that all visible labels are intact and legible Visually check that the exposure indicator is lit for the duration of exposure Check that exposure terminates and an error code is displayed on screen when prematurely releasing the exposure button Check all the functions of the SmartNav 8 3 PREVENTIVE MAINTENANCE PROGRAM Open the computer chassis and clean off all dust Check that both the power supply fan and the CPU cooler fan are working properly Check that all screws are tightened and all cables are visually in order Check that the unit is well fixed to the column wall Instrumentarium Dental 75 8 Maintenance Check the grounding from the LCD panel to the computer mains inlet and the OP200 D chassis Resistance must be less than 0 2 Ohms Verify that the OP vertical carriage is not able to hit the display supporting arm Check that appropriate operating system update is installed and virus definitions are up to date Do a complete system backup Calibrate the touch screen with a stylus by using the HID Calibration Tool 8 4 TOUCH SCREEN CALIBRATION AND OSD Run the program Figure 10
9. Setup is ready to install SmartNav Select nstall to start the Installation Smarthay InstallShield Wizard P 1 Heady to Install the Program x The wizard is ready to begin installation Click Install to begin the installation IF OU want bo review or change any of your installation settings click Back Click Cancel to exit the wizard InstallShreld Back i Cancel Instrumentarium Dental 33 3 SmartPad installation Setup shows installation progress x Setup Status hc y The InetallShield Wizard ts installing 5 martM av Installing SmartM avigator CAWINAT SMT TOUCHE BDO106 RMF DEER InstallShreld Cancel After installation the system must be rebooted Select Finish and the system will reboot automatically Smarthay InstallShield Wizard Reboot System System need ta be rebooted Close other applications Back Cancel 34 Instrumentarium Dental 200209 rev 3 3 SmartPad installation 3 12 REPAIRING SMARTNAV INSTALLATION Reinstalling SmartNav will launch the SmartNav maintenance program shield instead of the setup shield If there have been any problems with the workstation it is possible to try and repair the installation Select Repair from the maintenance screen Select Next SmartNay InstallShield Wizard i Ka Welcome Modify repair or remove the program Welcome to the SmartNav Setup Maintenance program This pragram lets
10. a grounding wire Instrumentarium Dental 23 3 SmartPad installation 3 7 FINALIZING THE INSTALLATION owitch the power on and attach the optical cables to the OP200 D 1 Attach the power cord to the mains connector located on the bottom of the SPC200 2 Switch the SmartPad on by pressing the button located next to the mains connector on the bottom of the SPC200 3 Now the SmartPad should be on the SmartPad starts and a green LED should be lit on the side of the SPC200 Switch on the OP200 D Check the optical cable jacks and optical cable connectors behind the OP200 D unit There should be a dim red light on one of the connectors on the OP200 D and on one of the optical cable jacks 6 Connect the optical cable with the red light to the lightless connector and the lightless cable to the connector with the red light on the OP200 D 7 The second green LED L should light up on the PCI card in the SmartPad Replace the SPC200 top cover 9 The SmartPad hardware is now installed 1 NOTE Optical cable is very sensitive for mechanical damages Route the optics cable properly so that all possible damage is avoided Ensure that enough free cable is left for up and down movement of the unit 24 Instrumentarium Dental 200209 rev 3 3 SmartPad installation 3 8 WALL MOUNTING SmartPad with embedded medical computer can also be mounted on a wall Prior to mounting locate the supporting material of the wall or a
11. disabled Every imaging program requires at least one section to be selected In P8 no sections can be disabled Imaging program P6 can be changed from TMJ lateral projection to Ortho TMJ axial corrected lateral projection and vice versa through the service program settings in the control panel Auto mode A is selected in the imaging programs P1 P5 Manual mode M is selected in the imaging programs P6 P10 and the exposure values can be changed manually 50 Instrumentarium Dental 200209 rev 3 5 Operating instructions 5 11 TAKING CEPHALOMETRIC EXPOSURES 170 mm KX D JA Fig 5 2 Yellow area is the exposure area which can be adjusted with the arrow p buttons d L 1 The exposure area in cephalometric lateral projection can be limited with the two large arrow button under the head figure The exposure area is adjusted 10 mm by pressing the arrow button once The effect of pressuring takes approx three seconds from omartNav to the OP200 unit After a few seconds the the arrow buttons return to enable state 2 Minimum area is 170 mm measured from 10 mm behind the ear rod to the back of the head E zi Maximum area 270 mm Minimum area 170 mm 200209 rev 3 Instrumentarium Dental 51 5 Operating instructions 5 12 TAKING VT EXPOSURES e NOTE See more detailed instructions in Volumetric Tomography User Manual and CliniView 7 User Manual Fig 5 8 VT panoramic P13 When the patient positio
12. dot Dark dots S 3 dots Total dot defects S 3 dots note 2 Note 1 For dot defect one sub pixel is defined as one dot Note 2 Distance between defective dots gt 15 mm PCI board connection PCI slot 68 Instrumentarium Dental 200209 rev 3 7 Technical specifications Orthopantomograph OP200 D with SmartPad accessory is suitable for use in the specified electromagnetic environment The purchaser or user should assure that it is used in an electromagnetic environment as described below Radio Frequency Emissions CISPR11 Radio Frequency Class B Emissions CISPR11 IEC 61000 3 2 Class D Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions Complies IEC 61000 3 3 Orthopantomograph OP200 D with SmartPad accessory uses RF energy only for its internal function Therefore the RF emission is very low and not likely to cause any interference in nearby electronic equipment Orthopantomograph OP200 D with SmartPad accessory 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 Orthopantomograph OP200 D with SmartPad accessory 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 purpose
13. product complies with DHHS regulations 21 CFR Subchapter J at the date of manufacture SSIF Vey EE FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH C US UL 60601 1 CAN CSA C22 2 NO 601 1 32ZX Manufactured by Instrumentarium Dental Nahkelantie 160 Fl 04300 TUUSULA Finland Fig 1 2 Main label 200166 Instrumentarium Dental 200209 rev 3 200209 rev 3 1 Introduction Fig 1 3 Location of the SmartPad display s type designation label SmartPad main label is located on the SPM200 power module in the option when user s own PC is used The unit is class and with IP 20 protection Because the unit can be changed from 230V line voltage connection to 115V line voltage there is separate main labels for both line voltages Fig 1 4 Location of the main label on the SmartPad Medical Power SPM200 MODEL SPM200 Ser No Date of manufacture 3 3 A 230 v 5060 Hz 770 VA C FUSES 4 A SLOW ws A IEC 60601 1 0537 IP 20 This product complies with DHHS regulations 21 CFR Subchapter J at the date of manufacture MEDICAL EQUIPMENT WITH one RESPECT TO ELECTRIC SHOCK i FIRE AND MECHANICAL HAZARDS U ONLY IN ACCORDANCE WITH d L US em CANICSA C22 2 xj MOOT 327X Manufactured by Instrumentarium Dental Hahkelantie 160 Fi 04300 TUUSULA Finland Main label for 230V line voltage Instrumentarium Dental MODEL SPM200 Ser No Date of manufacture 6 6 A115 bn 5060 Hz 770 V FUSES 8 A SL
14. stacking Relative humidity should be at least 30 percent The dissipative material should be connected to the system ground reference Instrumentarium Dental 73 7 Technical specifications 74 Instrumentarium Dental 200209 rev 3 8 Maintenance 8 Maintenance 200209 rev 3 Orthopantomograph OP200 D with SmartPad accessory is designed to provide reliable performance and many years of customer satisfaction In order to assure safe performance of this X ray system a preventative maintenance program must be established It is the owner s responsibility to supply or arrange for this service Consult your Orthopantomograph dealer to arrange for this service 8 1 MAINTENANCE SCHEDULE Maintenance service for SmartPad is suggested at installation and together with OP200 D maintenance This periodic maintenance is outlined in OP200 D Maintenance Manual These maintenance procedures require the services of a qualified technician In addition to periodic maintenance any deviation from normal performance should be immediately reported to your dealer and the equipment should be unplugged These include e The power cord or plug is damaged e The equipment has been exposed to moisture e Liquid has penetrated into the system e The equipment doesn t work correctly e The equipment has been dropped e The equipment has signs of breakage e f there are any unusual sounds or smells coming from the equipment N WARNING SERVICING THIS
15. 0 D power off SmartNav has lost the OP200 D connection DICC and SmartNav communication failure DICC and SmartNav communication failure 2 3 2 2 Release the emergency stop switch and turn the unit back on Start DICC client and enable image capturing He start the SmartNav He start the OP200 D computer and SmartNav Release the emergency stop switch and turn the unit back on Turn the OP200 D unit on He start the OP200 D computer Capture new image He start the SmartNav Re start DICC client CliniView Capture new image He start the SmartNav Re start DICC client CliniView Instrumentarium Dental 200209 rev 3 200209 rev 3 6 Troubleshooting PROBLEM POSSIBLE CAUSE REMEDY User program 1 OP200 D and Attempt to reset settings are not omartNav the user program updated communication settings problem failure Use the OP200 D control panel to reset the user program settings Different function Display calibration Calibrate the is selected than incorrect touch screen by the user pressed using the USB on the screen HID Calibration Tool Use a stylus for the most accurate calibration PCI board LED s EEPROM failure red yy Local reset red 4 A art lt e a A n Fig 6 1 PCI board LED s Instrumentarium Dental 63 6 Troubleshooting 64 Instrumentarium Dental 200209 rev 3 7 Technical specifications 7 Technical specif
16. 200209 rev 3 Instrumentarium Dental i 6 7 8 5 10 Taking panoramic ele 50 5 11 Taking Cephalometric exposures nennen 51 D T2 TAKN KEE AT ET 52 5 t3 User ageleet EE 54 VA SMO all e Ee LEE 57 EE LES e 57 5 16 M ltiple fmionttor SUDDOLELiss iius gut oa love deg ov ados dE ines a ees 59 TFOUDICSNOOUING WE 61 6 1 Diagnosing image quality problems nnnnneenenenennnnennsnnnsnnnrrennnrsnrrnrrrrrerrrennenne 61 6 2 Diagnosing equipment specific problems 62 Technical specifications ceisiais ndono aE daa 65 Mail telae e soroas uuaa eaaa iaa 75 o ee E eene TE 75 9 2 Monthly Inspection Dy E 75 8 3 Preventive maintenance program E 75 8 4 Touch screen calibration and OD 76 Instrumentarium Dental 200209 rev 3 1 Introduction 1 Introduction 200209 rev 3 1 1 INTRODUCTION Instrumentarium Dental Orthopantomograph OP200 D and Orthoceph OC200 D are software controlled diagnostic dental X ray equipment for producing high quality digital images of dentition TM joints and the skull An embedded medical computer with SmartPad touch screen display is connected to the OP200 D OC200 D unit for image capturing No additional computer is needed in this setup When a user wants to replace the embedded computer with an own non medical computer it will be connected via SmartPad Medical Power supply SPM200 to SmartPad system to provide electrical safety of the system This power module performs medical grade isolation for the Sma
17. Dental 200209 rev3 A no 5 Operating instructions Cephalo lateral projection P9 Cephalo PA projection P10 Volumetric Tomography mandible P11 Volumetric Tomography maxilla P12 Volumetric Tomography Panoramic P13 DENTAL ARCH v c Enabled arch sections in P1 Two sections disabled IMAGE MODEL X ray image model shows the enabled and disabled arch sections from the result point of view 589 E33 GY F3 3 GS Disabling sections of the dental arch is shown as limited image model 200209 rev 3 Instrumentarium Dental 43 5 Operating instructions 5 3 INFO SECTION AEC mode Manual mode EXPOSURE INDICATORS SA Exposure Indicator symbol Pediatric adapter symbol EXPOSURE VALUES 66 kV kV value field in AEC mode 8 0 UA mA value field in AEC mode kV and mA setting button in kV E n Manual mode m 17 6 S time value field 0 0 mGy dose value field i cm2 A Automatic exposure control T Test mode M Manual exposure control 44 Instrumentarium Dental 200209 rev 3 200209 rev 3 5 Operating instructions 5 4 OTHER SECTIONS GENERAL SETTING 5 User programs and pdf format manuals are available under the general setting button DENSITY SETTING Nine dose control steps Default setting is shown in the figure The dose is decreased when a lighter button is selected The dose is increased when a darker button is selected ICONS FOR PRE PROGRA
18. IVE SERVICE MESSAGE Pr59 Preventative maintenance reminder Reminder of preventative maintenance after every 2000 exposures To reset current counter value to 0 select Reset maintenance Q C Reminder OFF I Reset maintenance The preventative maintenance reminder can be set ON or OFF as necessary To reset current counter value to 0 select Reset maintenance LAST FAILURE CODE Pr62 Last failure code Select Reset to clear last failure code The last failure code can be seen in this dialog Reset takes effect as soon as the Last failure code dialog is closed 56 Instrumentarium Dental 200209 rev3 200209 rev 3 5 Operating instructions 5 14 GENERAL MANUALS GENERAL MANUALS OP200 user manual and user programs The manual button opens the general manuals dialog where it is possible to select one of the user manuals provided The selected manual is opened by the Adobe Acrobat program which can be downloaded from the Adobe www site When using SmartNav the pdf manual remains on the screen behind the SmartNav software unless the Adobe Acrobat is not closed separately 5 15 MESSAGES INFO GREEN MESSAGES e Ready for capture e Rotating unit is moving e X ray unit is in sequence RADIATING YELLOW MESSAGES e X ray unit is radiating CHECKS BLUE MESSAGES e Panorama camera not connected or imaging capture not enabled e Cephalostat ca
19. MMED TECHNIQUE FACTORS Child Juvenile Small adult Adult Large adult The dose is decreased when a smaller sized icon is selected The dose is increased when a larger sized icon is selected 5 5 REAL TIME STATUS OF THE UNIT Status field shows when the unit is ready for capturing or any trouble occurs Green yellow and blue colour indicate the status in question See chapter General settings for more detailed information Instrumentarium Dental 45 5 Operating instructions 5 6 HELP BUTTONS mu Instant dynamic help button ne Patient positioning animation NE button 4 INSTANT DYNAMIC HELP DYNAMIC HELP P7 TMJ PA projection PA view of the TMJ view with opened mouth Patient positionings buttons Smaller Press the dynamic help button once and then press the imaging program button The dynamic help dialog is shown on the screen for the selected imaging program 46 Instrumentarium Dental 200209 rev 3 200209 rev 3 5 Operating instructions PATIENT POSITIONING ANIMATION WINDOW Imaging program buttons Animation controls Animation display Progress bar Scene buttons The selected imaging program can be changed in the patient positioning animation window Each patient positioning procedure for each imaging program is composed of several scenes One patient positioning step can be played by pressing one scene button Progress bar sho
20. OW IEC 60601 1 0537 IF 20 This product complies with DHHS regulations 21 CFR Subchapter J at the date of manufacture MEDICAL EQUIPMENT WITH pas e RESPECT TO ELECTRIC SHOCK De FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH C us UL 60601 1 CANICSA C272 7 F NO GU 1 AQPX Manufactured by Instrumentarium Dental Nahkelantie 160 FI 04300 TUUSULA Finland i Main label for 115V line voltage 1 Introduction 1 4 CCESSORIES AND PREVENTIVE MAINTENANCE lf SmartPad is installed to a wall an optional 10 m optical cable part no 69061 is necessay For ethernet connections use an unshielded CAT5 CAT6 LAN cable These accessories are suitable for use with in the patient environment N WARNING The LAN cable shall be unshielded CAT5 CAT6 so that multiple chassis must not be connected The Ethernet HUB to which the medical grade computer is connected to should be approved appropriately e g EN 60950 IEC 60950 UL 60950 After installation check that the IEC 60601 1 leakage current levels are not exceeded e LI NOTE In order to maintain safe and correct functioning of OP200 D and SmartPad only the approved accessories may be used During normal operation any other detachable accessories mouse keyboard USB memory stick etc may not be connected to the embedded medical computer in the patient environment During maintenance the PS 2 mouse PS 2 keyboard and all USB accessories approved by Microsoft are
21. ROMPT BELOW IN WHICH CASE YOU AGREE THAT THIS AGREEMENT IS ENFORCEABLE LIKE ANY WRITTEN NEGOTIATED AGREEMENT SIGNED BY YOU IF YOU DO NOT CONSENT TO THE SOFTWARE LICENSE AND THIS PARAGRAPH PLEASE PRESS lt Cancel gt AT THE PROMPT BELOW IN WHICH CASE THE COTL 44 CODE DNA TE ARIE ACTII TLIC eT AALA MNA A TI ir accept the terms of the license agreement Print do not accept the terms of the license agreement Installshield Back Cancel 32 Instrumentarium Dental 200209 rev 3 200209 rev 3 3 SmartPad installation Customer information is required before the installation process can continue Enter customer information and select Next SmartNav InstallShield Wizard ERR Customer Information Please enter your information Please enter your name and the name of the company for which you work User Name User Company M ame PaloDEx Group Oy InstallShreld Back Cancel Select destination folder where SmartNav software will be installed By default SmartNav will be installed in the lt program files gt SmartNav folder Installation requires 200 Mb of free space on the hard drive Select Change if another destination is required other than default After the destination folder is chosen select Next E Choose Destination Location Select folder where setup will install Files Install Smart au ta C Program Filez S marth av Change InstallShreld i Cancel
22. SmartPad Installation amp User Manual 2 INSTRUMENTARIUM 200209 rev 3 Copyright Manufactured by Code 200209 rev3 Date 14 May 2007 Document code D500208 rev 3 Copyright 05 2007 by PaloDEx Group Oy All rights reserved Documentation trademark and the software are copyrighted with all rights reserved Under the copyright laws the documentation may not be copied photocopied reproduced translated or reduced to any electronic medium or machine readable form in whole or part without the prior written permission of Instrumentarium Dental The original language of this manual is English Instrumentarium Dental reserves the right to make changes in specification and features shown herein or discontinue the product described at any time without notice or obligation Contact your Instrumentarium Dental representative for the most current information CE 0537 Instrumentarium Dental Nahkelantie 160 P O Box 20 FI 04300 Tuusula FINLAND Tel 358 45 7882 2000 Fax 358 9 851 4048 For service contact your local distributor Table of Contents T niliil a d 1 FA e elle e WE 1 1 2 Markings graphics symbols and abbreviations cccccecccseeeeceseeseeeeeseeeesaeeees 2 PSs INANE EE 4 1 4 Accessories and preventive MAINTENANCE ue 6 tS M nulacturer SMI E 7 TG Ee ET EE 8 Bot d ai TE WE 8 IPSE CI FAW MSU ie E 8 2 SmartPad main e In CN 9 2 1 Embedded medical computer GC 2001 10
23. allowed Driver installation is not allowed N WARNING Both SmartPad and OP200 D OC200 D comply with IEC601 1 1 medical safety standards but in order to use other standards compliant equipment in the system the equipment EITHER has to be of medical grade or it has to be located at least 2 meters away from the OP200 D OC200 D unit The installer and the user of the system must confirm that at least one of the above requirements is fulfilled The equipment is medical grade if it complies with IEC 601 1 standards referred to in the accompanying documents N WARNING SmartPad Medical Power SPM200 complies with IEC60601 1 medical safety standards and therefore is suitable for use also with in the patient environment The system complies with medical safety standards if the external computer connected to OP200 D the SmartPad display and a possible external LCD display are powered through the SPM200 power module The external non medical grade PC and display should comply with relevant IEC standards It is not allowed to connect other non medical grade equipment printer scanner etc to the external PC system than the external LCD display that is powered through SPM200 6 Instrumentarium Dental 200209 rev 3 200209 rev 3 1 Introduction N WARNING The user shall not touch parts of non medical electrical equipment and the patient simultaneously 1 5 MANUFACTURER S LIABILITY As a manufacturer we can only assume liabi
24. asparency OSD timeout Languages Information Exit Restore factory presets Exit Exit D ko E T Full screen Maintain aspect ratio Center Phase adjust Clock adjust Exit Context sensible Text sharp Video smooth RGB adjust Color temp Black level adjust Exit Horizontal position Vertical position Normal Double 8 Maintenance FUNCTION DESCRIPTION Provides access to the setup submenu Adjust the setup video Adjust the setup geometry Access to the Auto setup options submenu Provides access to the setup submenu Allows to turn on or turn off the autoclock Exit from the auto setup options Regulates the overall brightness of the picture Regulates the contrast of the picture Provides access to the image adjust submenu Access to the geometry submenu Allows to adjust the horizontal position of the image Allows to adjust the vertical position of the image Select the picture size Provides access to the corresponding submenu Exit from the advanced submenu Exit from the advanced submenu Access to the video submenu Access to the submenu to select the picture clarity Provides access to the color submenu Adjusts the intensity of primary colours R G B Selects three colour temperatures for the picture Used to adjust the black level of the picture Exit from the color submenu Access to the OSD setting subme
25. atient positioning animation guide if needed 48 Instrumentarium Dental 200209 rev 3 200209 rev 3 ex 6 5 Operating instructions Unit real time status field at the bottom of the screen indicates if the system is warming up and when the system is ready for image acquisition Message Ready for capture is displayed when the system is ready A WARNING Turning off the X ray unit or the workstation during the exposure may cause the image to be lost 7 Press the exposure button when the system is in a Ready state The exposure must be made within the time out 1 10 min otherwise the image capture time expires The exposure indicator is lit when exposing SmartNav status displays X ray unit is radiating 8 SmartNav shows the image preview when exposing and after 2 3 seconds CliniView maximizes itself on the top of the screen showing the final image 5 9 PATIENT POSITIONING ANIMATION Select the necessary imaging program Press the patient positioning animation button The first animation frame of the selected imaging program is the default starting point In the patient positioning animation dialog it is possible to select another imaging program The first animation frame of the selected imaging program is the default starting point Instrumentarium Dental 49 5 Operating instructions term OOO 5 10 TAKING PANORAMIC EXPOSURES y G Enabled arch sections in P1 Two sections
26. cal Specifications 2 Make sure that the mains power is switched off and the AC input power cord is disconnected 3 Remove the cover of SMP200 by opening the ten allen key screws 4 Locate the terminal block of SMP200 Remove the line voltage cable connected to the transformer primary from 230V position and connect it to the 115V position on the primary side Remove the line voltage cable connected to the transformer secondary from 230V position and connect it to the 115V position on the secondary side Close the cover with the ten allen key screws Turn the main label around from 230V position to 115V position 7 Change the fuses to type 8A slow blow Littelfuse 326 series 8A Bussmann MDA series 8A 8 Connect the power cord and switch on the power module Instrumentarium Dental 29 3 SmartPad installation 115V connection 230V connection secondary 112v WIRING DIAGRAM W dec out MPS30 12 Fuses BOAT BE PRIO Sal soli A Jcus EES Ji L230 one PRI230 D SECO ee 0 115 MAINS INPUT te 115 OUTPUT 12Vde aut Fuses 4AT 230 MAINS INPUT L230 CS PR 230 OUTPUT 30 Instrumentarium Dental 200209 rev 3 3 SmartPad installation 3 11 SMARTNAV INSTALLATION e H Note Each required driver shall be installed to the SPC200 before starting the installation of SmartNav The driver installation guide is found from the drivers readme htm file on the Smar
27. contrast spine compensation Preventative service message Last failure code Pr51 Power up settings Select default imaging program and startup exposure mode Imaging program BAZEN Exposure mode Test Select the imaging program and the exposure mode which are on when the OP200 D is turned on 54 Instrumentarium Dental 200209 rev 3 200209 rev 3 5 Operating instructions CONSTANT CONTRAST SPINE COMPENSATION Pr52 and Pr58 General dose reference value for all imaging programs d Spine compensation Default kV Offset mode p4 Jee Jo Jas P2 ceo X gt asc J P3 fee vll JASc p4 vo o asc Ps o RE RH Pe 66 P7 o6 10 ps o P9 77 The general dose reference default value for all imaging programs is 5 0 Select the Default kV and Offset mode in every imaging program if needed Spine compensation can be set to P1 P5 OFF LO HI ASC OFF disables spine compensation It can be selected for pediatric patients When disabled the same kV value is used during the exposure cycle LO compensates the spine shadow by one mA step Lo 1 lt is a general selection for most patients HI compensates the spine shadow by two mA steps Hi 2 lt can be selected for large patients Select ASC for Automatic Spine Compensation 0 lt ASC lt 2 MA compensation will be determined automatically Instrumentarium Dental 55 5 Operating instructions PREVENT
28. d be used as primary When SmartPad has been defined as secondary monitor and is the only monitor with 800x600 resolution SmartNav should automatically configure itself to SmartPad display during bootup By using the multiple monitor manager of the USB touch screen driver the touch screen can be linked to SmartPad usually as a secondary display If the USB touch screen driver hasn t been installed it can be found from the SmartNav installation CD Please make sure that the multiple monitor support feature is selected to be installed Display Properties j ef Themes Desktop Screen Saver Appearance Settings Drag the monitor icons to match the physical arrangement of your monitors Sp Display 2 Multiple Monitors on AT MOBILITY RADEON 300 Color quality Highest 32 bit Use this device as the primary monitor Jh Extend my Windows desktop onto this monitor Identify Troubleshoot Advanced coed oem Screen resolution Less More DUU by 600 piselz 200209 rev 3 Instrumentarium Dental 59 5 Operating instructions 60 Instrumentarium Dental 200209 rev 3 6 Troubleshooting 6 Troubleshooting 6 1 DIAGNOSING IMAGE QUALITY PROBLEMS PROBLEM Images are too light Images are too dark Lack of image contrast Images are blurred Images are bloomed burned out POSSIBLE CAUSE Exposure factors used are too low Image adjustments have not been perf
29. es to remove Reinstall all program features installed by the previous setup Ta Remove all installed Features lnstallShreld Back Cancel Confirmation of removal must be accepted Select Yes SmartNay InstallShield Wizard i X Do vau want to completely remove the selected application and all of its Features 36 Instrumentarium Dental 200209 rev3 200209 rev 3 3 SmartPad installation A list of running SmartNav related processes is displayed before starting the uninstallation Select Next Smarthay InstallShield Wizard E Running Processes x Following processes must be terminated before setup can continue Press lt NEXT gt button to terminate processes s Back Cancel InstallShreld Setup uninstalls SmartNav After uninstallation the system must be rebooted Select Finish to exit the maintenance program the system will reboot automatically Smarthay InstallShield Wizard E Reboot System System needs to besebooted Close other applications 4 Back i Lance Instrumentarium Dental 37 3 SmartPad installation 38 Instrumentarium Dental 200209 rev 3 4 Equipment care 4 Equipment care 200209 rev 3 4 1 CARE INSTRUCTIONS X ray imaging systems are sophisticated electronic products that include advanced technologies As such they have to be handled with a high degree of care This document gives the care instructions applicable to the SmartPad
30. format This user amp installation manual covers the usage and installation of omartPad Refer to your SmartPad manuals before installing or using the SmartPad and SmartNav software See your Windows manuals for further information about the Windows environment SmartNav works with Windows XP Professional operating system Instrumentarium Dental 1 1 Introduction LI NOTE SmartPad must be installed according to the SmartPad installation manual by a qualified technician Only trained personnel should be allowed to operate SmartPad 1 2 MARKINGS GRAPHICS SYMBOLS AND ABBREVIATIONS The following markings are used in this manual NOTE Contains useful information for the reader about the unit and its use N CAUTION Contains important instructions If these instructions are not observed malfunction of the unit or damage to the unit or other property may Occur N 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 OP200 D and SmartPad UL Radiographic control Protective earth ground AC Alternating current Attention consult accompanying documents Instructions and warnings in OP200 D and SmartPad manuals must be followed GI o If the unit has CE marking it is CE marked according to the Medical Device Directive 93 42 EEC 2 CP Go e
31. h 39 AC input 40 AC output A 41 AC output B 42 SmartPad display power supply 12VDC 43 Protective ground connector 44 Main label reversible for 230V 115V 45 Fuses e NOTE Combined load on outputs A B must not exceed 700VA 200209 rev 3 Instrumentarium Dental 15 2 SmartPad main parts 2 SPM200 WIRING DIAGRAM 1l1lov WIRING DIAGRAM tleVvdc aut MPS30 12 Fuses BOAT TE P lle NTC 115 MAINS WE a am ERE L230 ome aed ele D SECO o eli CHON sEL dU 1135 OUTPUT Pee Tt aa ES OUTPUT uj T 230V WIRING DIAGRAM LEW dc aut Fuses 4A T al MS 20 L 230 MAINS INPUT 15 550115 230 est 230 OUTPUT 16 Instrumentarium Dental 200209 rev3 3 SmartPad installation 3 SmartPad installation 3 1 GENERAL N WARNING SERVICING AND INSTALLING THIS UNIT WITHOUT ADEQUATE EXPERTISE IS EXTREMELY DANGEROUS Instrumentarium Dental recommends that all service operations are performed by authorized Instrumentarium Dental service personnel N WARNING Prevent unauthorized access to the unit during the installation process Some internal parts of the unit have dangerous voltage levels which may be exposed during installation when the unit covers have been removed This chapter covers the installation of SmartPad with the embedded medical computer system and with the SmartPad Medical Power SPM200 As the manufacturer we strongly recommend
32. he wall outlet otherwise patient s or user s safety might be threatened N WARNING Combined load on outputs A B must not exceed 700VA N WARNING SmartPad Medical Power SPM200 shall not be placed on the floor to prevent the ingress of liquids and to prevent mechanical damage N WARNING Additional multiple portable socket outlets shall not be connected to SPM200 system 28 Instrumentarium Dental 200209 rev 3 200209 rev 3 3 SmartPad installation N WARNING SPM200 shall be used only for supplying power to equipment which is intended to form part of the system Otherwise patient s or user s safety might be threatened e NOTE SmartPad Medical Power SPM200 includes a high power isolation transformer so it is not advisable to switch on the module repeatedly because a fuse will be blown If you switch of the module please wait for 1 2 minutes before switching the module on again 3 10 CHANGING THE LINE VOLTAGE CONNECTION The power modules are delivered from factory with 230V line voltage settings If you have to change to 115V line voltage read this chapter for instructions N WARNING Only authorised technician is allowed to perform the change between 230V and 115V line configurations N WARNING Do not connect the mains power until instructed to do so 1 Make sure that the power line meets the requirements set by the manufacturer for the SPM200 For more details see chapter Techni
33. ications Manufacturer Instrumentarium Dental Nahkelantie 160 P O Box 20 FIN 04300 Tuusula FINLAND Quality system In accordance with ISO9001 standard Environmental In accordance with ISO14001 standard management system Electrical amp mechanical According to IEC 60601 1 UL and C safety UL File E301913 CE models marked according to the Medical Device Directive 93 42 EEC Product type omartPad Option for OP200 D OC200 D Class Protection IP 20 Operation Continuous operation Power supply Mains plug connection First software version Release 1 0 dated 1 6 2006 by Instrumentarium Dental Standards this unit IEC 60601 1 complies with UL 60601 1 MDD 93 42 EEC if the unit contains CE mark UL CSA file Exxxxxx if the unit contains UL CSA mark Electrical connections Nominal mains voltage 100 240 VAC full range Input power frequency 50 60 Hz 200209 rev 3 Instrumentarium Dental 65 7 Technical specifications Electrical connections Nominal current 2A 230 VAC 4A amp 110 VAC Fuses Inside the power supply Maximum impedance of 1 00 main User interface Program and technique omartNav factors selection Connection to OP200 D Optical link Connection cable Optical fibre 1 7 m OP200 D computer SmartPad physical measures Installation OP200 D column or wall mount Height x Width x Depth computer 466 x 204 x 111 mm P mm Monitor with supporting arm 234 x 750
34. l NO Instrumentarium Dental 200209 rev 3 200209 rev 3 1 Introduction If the unit has UL marking it is UL marked according to UL60601 1 and CAN CSA C22 2 No 601 1 SSIF v c e en 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 x i N O Personal computer HDD Hard disk drive Hertz cycles per second c SR N Millions of hertz O 5 c Central processing unit computer Random access memory UJ OIO JJ omo y Z Mega bytes Giga bytes UJ Compact disc read CD RW Compact disc read and write DVD RW Digital Versatile Disc read and write Peripheral Component Interconnect LAN Local Area Network C2 Instrumentarium Dental 1 Introduction 1 3 MAIN LABEL The type and version of the SmartPad is defined in the main label of the unit located on the bottom of the embedded medical computer next to the power cord socket The unit is class and with IP 20 protection The type designation label of the SmartPad display is located on the bottom part of the display 1 Fig 1 1 Location of main label and CE mark MODEL Ser No Date of manufacture 4A 100 240 V 50 60 Hz f IEC 60601 1 IP 20 CE H This
35. l 13 XL FEE 34814 NOLLNG s OWI 28 109 440 NO SS LES quvOg lod om Lax H Litt ggl A FLOU aad D 4SIQ pJ amp H JIN EA oan KE aa Em COCO0Z RER 183 a 00290 d 00CdO JINNI JHL 40 NYT HYOARLAN Wad 1 I07 IHL OL LfldNI 2f Sr eg Lei zzv 00d 082007 Se SS JaMOd X 1v IEIIP N A 662002 ENORMES Pe XLN ZX voten SOND PS 21988 u041u05 l HNOJ Ni xd Hit YOLINOW z Ajquasse LOZOOZ pou 0 L002 jquiesse 681002 mtl Od Pegueus o0cOdS JO IUOW PEJHBWS QOZd 1S O02 d0 JHL JO LNIO d SNIGNNOYS JHL OL oJ 2 5 WIRING DIAGRAM 2 SmartPad main parts 200209 rev3 Instrumentarium Dental 14 2 SmartPad main parts 2 6 SMARTPAD MEDICAL POWER SPM200 When a user wants to replace the embedded computer with an own non medical computer it will be connected via SmartPad Medical Power supply SPM200 to SmartPad system to provide electrical safety of the system SPM200 includes a medical grade power supply for the SmartPad display STP200 and a medical grade isolation transformer for powering the external PC An external LCD display can also be powered through the transformer if the PC supports the connection of multiple monitors SmartNav software runs on the external PC and the GUI is shown on the SmartPad display The external display can be used for viewing other programs e g practice management softwares that are run on the PC NU E a e 38 Mains switc
36. lity for safe and reliable operation of this unit when e emartPad installation was performed according to the SmartPad Installation Manual and e SmartPad is used according to the SmartPad User Manual e Maintenance and repairs are performed by a qualified Orthopantomograph Dealer and e Original or authorized spare parts are used e SmartNav software is installed and used according to the User Manual Safe and reliable usage of the product requires that the user has read and followed the instructions and observed the restrictions given in the manual We recommend that qualified serviceman check that the unit is in its original condition regarding electrical radiation and mechanical safety according to our maintenance program and described in more details in the Maintenance chapter For more information please contact your local dealer If service on the unit 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 work order for future reference LI NOTE For computer systems Instrumentarium Dental can guarantee OP200 D PCI board and CliniView software compatibility with other computer hardware and software only if that configuration has been tested by In
37. mera not connected or imaging capture not enabled Please select correct collimator Mains line voltage is out of range Please press patient positioning button before taking exposure Maintenance recommended Instrumentarium Dental 57 5 Operating instructions Exposure allowed only from remote exposure button Communicaton to the workstation failed Please check ceph earholder position Exposure values out of range Calculation of dose not possible Dose will not be displayed Please check biteplate orientation or remove biteplate Please wait seconds before next exposure WARNINGS ORANGE MESSAGES Rotating movement error Please check that X ray unit parts do not touch the patient If same error reappears call e NOTE Message can be closed by clicking CLOSE button Tubehead too hot Cooling time at least 1 hour Tubehead or generator error during the exposure cycle Try again If same problem reappears call service Exposure button was released before the end of exposure Inverter error during exposure Filament error during exposure AEC signal missing EEPROM write failed Rotating movement error Please check that X ray unit parts do not touch the patient If same error reappears call service Linear movement error Carriage up down movement error If same error reappears call service Cephalostat movement error Cephalostat beam alignment erro
38. nding cable to the OP200 column with a M4 x 4 screw N B maximum length and to the ground connector on the computer front panel see chapter front panel of the SPC200 2 Connect the SmartPad power cable VGA cable USB cable and the grounding cable to the computer connectors 3 Bring in the optical cables through the larger opening on the SPC200 from the side that the optical connectors are located on 4 Connect the optical cables and secure them through the catch that is located on the side of the SPC200 just below the opening 5 If an Ethernet connection is needed plug the LAN cable into the computer socket before putting the cover plate on so the LAN cable can run inside the cover A WARNING The LAN cable shall be unshielded CAT5 CAT6 so that multiple chassis must not be connected The Ethernet HUB to which the medical grade computer is connected to should be approved appropriately e g EN 60950 IEC 60950 UL 60950 After installation check that the IEC 60601 1 leakage current levels are not exceeded 6 Place the cover plate on and secure it with the nuts 22 Instrumentarium Dental 200209 rev 3 200209 rev 3 3 SmartPad installation NOTE Connect also the SmartPad display grounding cable to the embedded computer grounding point A WARNING Never use LCD if the power cord has been damaged A WARNING The OP200 column the SPC200 and the supporting arm MUST be interconnected by
39. ning device for VI panoramic exposure is installed to OP200 D unit the unit selects automatically the VT panoramic exposure mode program 13 Correct collimator PAN has to be selected Fig 5 4 VT projection for maxilla P12 52 Instrumentarium Dental 200209 rev 3 200209 rev 3 5 Operating instructions Fig 5 5 VT projection for mandible P11 Install the patient positioning device for projection procedures and select correct collimator VT Select correct VT program program 11 for mandible or program 12 for maxilla imaging SmartNav shows the exposure area incisor canine molar that has been selected from the patient positioning device VT projection parameters can be changed by opening the parameter window You can change the aperture angle and the number of projection images for VT procedure PROJECTION PARAMETERS Aperture Angle lt 40 BE Number of Projection Images GROEN Fig 5 6 Projection parameters omartNav goes automatically to VT exposure mode when VT calibration tool is connected VT panoramic procedure program 13 and VT projection procedure program 11 12 can be selected from omartNav in order to go through the calibration procedure Instrumentarium Dental 53 5 Operating instructions 5 13 USER PROGRAMS NOTE The user program setting takes effect as soon as the user program settings dialog is closed USER PROGRAM SETTINGS Power up settings Constant
40. nment The purchaser or user should assure that it is used in an electromagnetic environment as described below Immunity Test IEC 60601 1 2 Compliance Electromagnetic Environment Test Level Level Surge 1 kV differential 1 kV differential Mains power quality is that of a IEC 61000 4 5 mode mode typical commercial and or hospital 2 kV common 2kV common environment mode mode Voltage dips lt 5 U lt 5 U Mains power quality is that of a short gt 95 96 dip in Uh gt 95 dipinU typical commercial and or hospital interruptions for 0 5 cycle for 0 5 cycle environment If the user of and voltage 40 96 U 40 96 U Orthopantomograph OP200 D variations on 60 dip in U 60 dip in U requires continued operation during power supply for 5 cycles for 5 cycles power mains interruptions it is input lines 70 96 U 70 96 Ui recommended that IEC 61000 4 11 30 dip in U 30 96 dip in Ux Orthopantomograph OP200 D for 25 cycles for 25 cycles with SmartPad accessory is 596 U lt 596 U powered from an uninterruptible gt 95 dip in U gt 95 dip in U power supply or a battery Power Power frequency magnetic fields frequency are at levels characteristic of a 50 60 Hz typical location in a typical magnetic field commercial and or hospital IEC 61000 4 8 environment NOTE U is the a c mains voltage prior to application of the test level Table 7 2 Electromagnetic immunity IEC 60601 1 2
41. nu Adjusts the vert and hor position of the OSD menu ci sed to adjust the size of the OSD menu sed to adjust the trasparency of the OSD menu ets the duration of the OSD menu U S Used to select the language of the OSD menu Used to view the version of the monitor firmware Exit from the OSD setting submenu Used to restore the setting made by the manufacturer Exit from the image adjust submenu Exit from the OSD menu Instrumentarium Dental 81 8 Maintenance 82 Instrumentarium Dental 200209 rev 3 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 O 05 2007 by PaloDEx Group Oy All rights reserved Instrumentarium Dental P O Box 20 Fl 04301 Tuusula Finland Tel 358 45 7882 2000 Fax 358 9 851 4048 Americas Instrumentarium Dental Inc Milwaukee Wisconsin U S A Tel 800 558 6120 Fax 414 481 8665 SmartPad INSTRUMENTARIUM station amp User Manuel Engish 200209 rev 3 Printed in Finland 05 2007
42. or the keyboard is placed in different position but the sequence and the function of the keys is the same In this paragraph there is the description of the keys functionalities the image in this page is only an example of the keyboard to help the user OOOOOCOOO OQOOOOOOOCOOODOOOOOOOOOCOOO OOoOOOOOO OOOOOOOOOOOOOOOOOOOOOOO OOoooocooQo paye ais d Ameis d ai AA i ESSENSEN 00000000 JO0O000000000000 OC 00000000 38000000000 OOOOOOOOOCOOO Key F To display the principal menu and the other sub menu To select the interested regulation and after save it Key To scroll down the menu and to adjust the level of the control Key To scroll up the menu and to adjust the level of the control After having optimized the regulations the formulas are memorized automatically You can exit the OSD menu after 10 seconds of inactivity it is possible to set the OSD timeout or to exit the menu with EXIT The items of the main menu and submenus are listed together with the description of the function in the following table 80 Instrumentarium Dental 200209 rev 3 200209 rev 3 OSD STRUCTURE Setup functions Setup video Setup geometry Autosetup options Autosetup on mode set Enable autoclock uM Exit Brightness Contrast Image Adjust Geometry Horizontal position Vertical position Scale center Advanced Exit Video Image enhancement Color OSD setting OSD position OSD size OSD tr
43. ormed Exposure factors used are too high Image adjustments have not been performed KV used is too high Image adjustments have not been performed The patient moved The X ray source moved Incorrect integration time Excessive exposure time Instrumentarium Dental REMEDY Increase exposure factors Adjust the image brightness contrast and gamma using CliniView software Decrease exposure factors Adjust the image brightness contrast and gamma using CliniView software Lower the kV value if possible Adjust the image contrast using CliniView software Prevent patient movement Prevent X ray unit movement or have the unit serviced Set the integration time in CliniView to be longer than the exposure time Set shorter exposure time Change to a long cone on the X ray unit 61 6 Troubleshooting 6 2 DIAGNOSING EQUIPMENT SPECIFIC PROBLEMS PROBLEM POSSIBLE CAUSE REMEDY OP200 D goes 1 Power failure 1 Turn the OP200 down D unit on omartNav goes Power failure Re start down omartNav Power failure Image capturing not enabled Unit does not react when buttons are pressed Could not establish connection to X ray unit Preview image does not appear on the screen Image capturing is not enabled 62 Emergency stop switch is used DICC client CliniView is not started SmartNav is in undefined state Emergency stop Switch is used OP20
44. ovement up and down movement motor cable while placing the holders to the column slots Embedded computer holder pin SmartPad mounting points stopper screws left or right sided installation Grounding point 18 Instrumentarium Dental 200209 rev 3 200209 rev 3 3 SmartPad installation Slot for the Z movement motor power cable MLL 2 Place the holders in the column slots so that the embedded computer holder pin faces upwards Temporarily loosen the stopper screws to allow the fastening holders to be placed to the column slots To prevent the Z motor cable from being damaged the cable should be located in the dedicated cable slot while installing and tightening the display bracket 23 Column slot stopper screw Sc Z motor power cable 3 Measure and mark 940mm from the base of the OP200 D column o g Instrumentarium Dental 19 3 SmartPad installation 3 4 INSTALLATION OF SMARTPAD DISPLAY BRACKET Install the display bracket and SmartPad 1 20 Decide onto which side of the OP200 D unit you wish to install SmartPad Install the SmartPad display bracket to the fastening holders 2 pcs of M6x20 mm hexagon socket head cap DIN912 screws with washers Match the display bracket s upper edge with the 940 mm mark Use a spirit level to ensure that the display bracket is horizontal Install the grounding cable to the display bracket grounding point while fastening the bracket
45. r Call service to check beam alignment Please check camera connection If same error reappears call service ERRORS LIGHT ORANGE MESSAGES A Could not establish connection to x ray unit Check the connection and that you have not pressed the emergency power switch e NOTE Message cannot be closed but it can be minimized e CPU processing error Call service e CPU RAM check error Call service 58 Instrumentarium Dental 200209 rev 3 5 Operating instructions CPU ROM check error Call service Line voltage error Call service Filament board or connection error Call service Input error Please make sure no buttons are pressed during startup If same error reappears call service Lease or test exposure limit has been reached Call service e Could not establish connection to x ray unit e Check the connection and that you have not pressed the emergency power switch e Could not execute OP server process Restart system 5 16 MULTIPLE MONITOR SUPPORT omartNav and the USB touch screen driver of SmartPad support the use of multiple monitors In order to be able to use this feature the display adapter of the external PC has to have at least to VGA DVI outputs up to date display adapter driver has to be installed and Windows extended desktop has to be enabled and configured SmartPad should be used as a secondary display with 800x600 resolution and the external LCD display shoul
46. rogram returns to the main window Choose Yes to verify the accuracy of the touch screen No to exit Calibration completed successfully Do you wart to test the calibratior wath the draw test Fig 8 6 Step 4 Once the calibration is acceptable press ESC to exit the program 78 Instrumentarium Dental 200209 rev 3 200209 rev 3 8 Maintenance Fig 8 7 Step 5 Press Yes on the last menu in order to terminate the program At this point the touch screen is calibrated and the monitor can be fully used Fig 8 8 Step 6 OSD This chapter describes the On Screen Display OSD program used to make the logical adjustments on the monitor contrast brightness position of picture clarity of picture and colour temperature of picture The OSD program can be accessed whenever the computer is on when it is off or in energy saving mode the OSD program is not accessible Instrumentarium Dental 79 8 Maintenance OSD provides a quick and easy way to make the logical adjustments on the monitor To access the OSD main menu press the F button at the rear panel of the monitor To scroll through the menu items and to increase or decrease the value displayed use the other buttons on the rear of the monitor to activate a menu item after selected it press the F button again For more information read the keyboard section Keyboard In the back of the monitor there is a keyboard For every type of monit
47. rtPad display and the user s PC A desktop LCD display can also be powered through the module if the PC supports the connection of multiple monitors With this setup SmartNav can be run on the SmartPad display and the other LCD display can be used for running a practice management software PMS omartPad is a full color high resolution LCD display with touch screen interface The SmartPad produces a menu easy to read and follow with simple and intuitive navigation through the operations omartPad can only be used with Orthopantomograph OP200 D and Orthoceph OC200 D digital units SmartPad can be installed either in the OP200 D OC200 D unit or to a wall omartNav software provides easy selection of imaging programs arch sections lateral scanning start position and more SmartNav is used together with the OP200 D control panel The exposure button can be found on the OP200 D control panel The following operations can be performed with SmartNav assuming that all the other equipment are ready for use Selection of imaging programs oelection of arch sections Selection of lateral scanning start position oelection of user programs oetting of user parameters oelection of the patient positioning animation to be shown on omartPad touch screen to support correct clinical use of OP200 D OC200 D Selection of exposure values Preview of exposed X ray images Instant Dynamic help for imaging program purposes Complete User Manuals in pdf
48. s Orthopantomograph OP200 D with SmartPad accessory 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 7 1 Electromagnetic emissions IEC 60601 1 2 Ed2 Orthopantomograph OP200 D with SmartPad accessory is suitable for use in the specified electromagnetic environment The purchaser or user should assure that it is used in an electromagnetic environment as described below Immunity Test IEC 60601 1 2 Compliance Electromagnetic Environment Test Level Level 2 4 6 kV for contact discharge 2 4 8 kV for air discharge Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 t 2 kV for power supply lines 1 kV for input output lines 2 4 6 kV for contact discharge 2 4 8 kV for air discharge Floors are wood concrete or ceramic tile or floors are covered with synthetic material and the relative humidity is at least 30 percent t 2 kV for power supply lines Mains power quality is that of a typical commercial and or hospital environment 1 kV for input output lines Table 7 2 Electromagnetic immunity IEC 60601 1 2 Ed2 200209 rev 3 Instrumentarium Dental 69 7 Technical specifications Orthopantomograph OP200 D with SmartPad accessory is suitable for use in the specified electromagnetic enviro
49. ss of liquids and possibility of mechanical damage is prevented during normal use 2 Prior to mounting locate the supporting material of the wall or a mounting surface and choose the mounting system according to examples in the following table Mount the base frame so that the four holes at the bottom Insert M4x12 screws to the lowest holes of the frame to support the module when slided to the frame SPM200 and the external PC shall be located near each other for easier cabling K25 HSA expansion M6 M6 x 50 Concrete anchor HKD S flush DIN 912 DIN 125 Concrete anchor M6x30 B6 4 wall s 3 Wood Hex head M6 DIN 571 DIN 125 frame wall wood screw 6x45 B 6 4 4 Steel Installing frame directly to steel framing is not allowed 0 e gn al ly LA AM Instrumentarium Dental 27 200209 rev 3 3 SmartPad installation 3 4 9 Install the SmartPad display power cable to the 12VDC connector 42 Connect the VGA and the USB cables to the PC and the display grounding cable to the protective grounding point 43 on SPM200 Use IEC320 extension cables to connect the AC supply from outputs A and B 40 amp 41 to the PC and a possible external LCD display Connect the power cord to AC input 39 and switch the power on from the mains switch 38 The external non medical grade PC and LCD display used as part of the system are intended to be supplied via SPM200 they shall not be connected directly to t
50. strumentarium Any later changes to the hardware or software may void this test N WARNING The openings on the enclosures are for air convection Protect the equipment from overheating Do not cover the openings N WARNING Never insert anything metallic into the openings Doing so may create a danger of electric shock Instrumentarium Dental 7 1 Introduction 1 6 DISPOSAL Follow all local regulations on disposal of waste parts At least SmartPad electronic circuits should be regarded as toxic waste products 1 7 MANUAL All SmartNav functions can be selected with the graphical symbols in the windows and dialogs This manual describes the procedure by using graphical symbols The graphical symbols used are shown beside the text LI NOTE Touching the screen means pressing the screen once with the forefinger Clicking means pressing the left mouse button once 1 8 GENERAL INSTRUCTIONS In order to obtain full advantage of SmartNav you should be familiar with the functionality of the operating system It is important to use the SmartPad full color high resolution touch screen SmartPad should be operated in subdued light and away from strong direct light If the equipment is not used for a long time disconnect it from the mains to avoid damage by transient overvoltage 8 Instrumentarium Dental 200209 rev 3 2 SmartPad main parts 2 SmartPad main parts SmartPad SPC200 embedded medical computer
51. tNav installation CD Start installation by inserting SmartNav installation CD into the CD ROM drive use external CD ROM drive with USB connection for omartPad The installation starts automatically Installation can also be started by executing setup exe on root of installation media 200209 rev 3 Instrumentarium Dental 31 3 SmartPad installation The setup Main screen is shown at the beginning Select nstall SmartNav for installation SmartNav 1 1 J Install SmartNav J Option Install Calibration Tool 3 Browse CD 3 Exit Setup shows a welcome screen at the beginning The screen displays the SmartNav version to be installed Select Next SmartNay InstallShield Wizard xj Welcome to SmartNay 1 1 0 2 Setup This program will install amp martM av on your computer To continue click Next Cancel License agreement must be accepted before SmartNav can be installed After reading the license agreement please select the Accept option and press Next Smarthay InstallShield Wizard License Agreement Please read the following license agreement carefully SOFTWARE LICENSE THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU AS THE lt LICENSEE gt AND P amp LODEs GROUP Oe THE lt LICEN SOR GOVERNING YOUR RIGHT TO USE THE SMARTNAY SOFTWARE Software IF YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS OF THE SOFTWARE LICENSE AND THIS PARAGRAPH PLEASE PRESS lt I Agree AT THE P
52. 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 Orthopantomograph OP200 D with SmartPad accessory to verify normal operation in each use location If abnormal performance is observed additional measures may be necessary such as re orienting or relocating of the system Over the frequency range 150 kHz to 80 MHz field strengths are less than V V m The Recommended Separation Distances are listed in the next table Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table 7 8 RF immunity of non life support equipment or system IEC 60601 1 2 200209 rev 3 Instrumentarium Dental 71 7 Technical specifications e P Note This equipment generates uses and can radiate radio frequency energy If not installed and used in accordance with this manual it may cause harmful interference to radio communications Portable and mobile RF communications equipment can also affect the performance of OP200 D and SmartPad Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601 1 2 Frequency of 150KHz to 80 MHz to 800 MH
53. that you read this manual before installation For information about how to use the SmartPad OP200 D unit and CliniView software please refer to the appropriate manuals These manuals and future updates will be available on request from Instrumentarium Dental As the manufacturer we strongly recommend that you read understand and follow the SmartPad and OP200 D manuals before using this system Use only approved cables plugs and fuses Mains connector types NEMA 5 15P or similar Hospital grade US 110 V Power supply cord For UL countries SJT 3 x AWG 16 18 HO5VV F 10 16A 250V CE Fuses for SPM200 230V line voltage Littelfuse 326 series 4A slow blow Bussmann MDA series 4A time delay 115V line voltage Littelfuse 326 series 8A slow blow Bussmann MDA series 8A time delay 200209 rev 3 Instrumentarium Dental 17 3 SmartPad installation 3 2 PREPARATIONS Switch the power off and remove the column back plate 1 Switch the OP200 D power off 2 Remove the counter weight servicing plate behind the column by opening four allen key screws 3 3 INSTALLING THE FASTENING HOLDERS Install the fastening holders for the display and the SPC200 embedded computer and measure and mark the installation height of 940mm e NOTE Do not drop the fastening holders or other parts into the OP200 column 1 Insert the fastening holders 2 pcs into OP200 unit column slots Do not harm the Z m
54. tyl alcohol soap Isopropyl alcohol distilled water Prohibited bentzene chlorine bentzene acetone acetic ether agents containing phenol paracetic acid peroxide and other oxygen cleaving agents sodium hypochlorite and iodine dissolving agents Never use corrosive or solvent disinfectants All items and surfaces should be dried before further usage N WARNING Do not use any cleaning sprays as the vapor could ignite and cause injury 40 Instrumentarium Dental 200209 rev 3 5 Operating instructions 5 Operating instructions 5 1 SMARTNAV MAIN WINDOW Imaging program Info section section Settings Help section Real time status of the unit 5 2 IMAGING PROGRAM SECTION DoDD f GY dm In panoramic imaging programs the dental arch and image model are program specific 200209 rev 3 Instrumentarium Dental 41 5 Operating instructions 170 mm eq OW Ke Fig 5 1 Model heads for imaging programs P9 and P10 In cephalometric imaging programs the model head and setting buttons are program specific IMAGING PROGRAMS Standard Panoramic P1 Pediatric Panoramic P2 Ortho Zone enhanced Panoramic P3 Orthogonal Panoramic P4 Wide arch Panoramic P5 TMJ lateral projection P6 or Ortho TMJ axial corrected lateral projection optional P6 TMJ posterior anterior projection P7 Maxillary Sinus View P8 DD on on Instrumentarium
55. ws which animation scene is displayed on the screen Instrumentarium Dental 47 5 Operating instructions ANIMATION CONTROLS Half speed button Full speed button Start imaging program animation Start animation scene One step back for one animation scene Scene button Pressing the button during playing pauses the animation scene Re pressing the button continues the scene Button for patient positioning animation of imaging programs P1 P5 5 7 STARTING SMARTNAV To start the SmartNav Software click the i logo in the floating SmartNav dialog or the SmartNav icon on the desktop or open the software from Start menu Programs gt SmartNav The SmartNav dialog can be dragged to different corners on the screen The keyboard button opens the floating keyboard on the screen 5 8 CAPTURING IMAGES N CAUTION Do not run other programs while taking X ray images The imaging system uses all the resources of the workstation 1 Launch or activate CliniView or other DICC image capturing software The SmartNav software minimizes itself automatically Select patient from CliniView Press the Start image capturing button e g in CliniView or otherwise enable the image capturing 4 SmartNav maximizes itself automatically on the top of the screen oelect the necessary imaging program and other settings e g exposure values modes and density or patient size 5 Position the patient Use the SmartNav p
56. x 126 mm Weight computer 5 kg Monitor with supporting arm 4 kg ccc eso esa aaa EEN SmartPad Medical Power SPM200 data Model SPM200 Protection Applied part Mains Voltage 230 Vac 10 115 Vac 10 Input power frequency 50 60 Hz Fuses 4 A slow blow 230Vac 8 A slow blow 115Vac 66 Instrumentarium Dental 200209 rev3 7 Technical specifications Outputs AC Two 230 115 Vac total max 700 VA Outputs DC 12 VDC max 2 5 A Height x width x depth 284 x 196 x 131 mm Environmental Requirements Operation Temperature 10 4 40 C range Transportation and 10 450 C storage temperature range Operating humidity Max 95 RH non condensing Transportation and Max 95 RH non condensing storage humidity embedded medical computer system Platform Intel Pentium M Intel Celeron M Mini ITX Processor Celeron M 1 3GHz Chipset Intel 855GME and Intel 6G300ESB Embedded Chipset Hard disk 40GB HDD minimum connection PCI board connection 200209 rev 3 Instrumentarium Dental 67 7 Technical specifications amp resistive touch screen Electrical inspection Line defect Can t be seen specification Bright dots lt 2 dots note 1 Green bright dots S 1
57. you modify the current installation Click ane of the options below Modify Select new program features to add or select currently installed features to remove KE Reinstall all program features installed by the previous setup C Remove E Remove all installed features lnstallahreld 4 Back Cancel If there are SmartNav related processes running on the system setup shows a list of them Setup terminates the processes if Next is selected Smarthay InstallShield Wizard E Running Processes Following processes must be terminated before setup can continue Press lt NEXT gt button to terminate processes SmartM ay Se Back Cancel InstallShreld Instrumentarium Dental 35 3 SmartPad installation Setup reinstalls software components When the maintenance operations have ended select Finish Smarthay InstallShield Wizard Maintenance Complete Install hield Wizard has Finished performing maintenance operations an Smarth av 4 Back 3 13 REMOVING SMARTNAV Maintenance screen also offers a software removal option Selecting Remove and Next starts the uninstallation Smarthay InstallShield Wizard x Welcome Modify repair ar remove the program Welcome to the SmartM av Setup Maintenance program This program lets you modify the current installation Click one of the options below Select new program features to add or select currently installed featur
58. z to Transmitter 80 MHz 800 MHz 2 5 GHz Equation d 2WP det NP d LWP Vi Ei E Rated Maximum Separation Separation Separation Output Distance Distance Distance Power of meters meters meters Transmitter watts Fig 7 1 Table 4 USE LIMITATION External components The use of accessories transducers and cables other than those specified may result in degraded ELECTROMAGNETIC COMPATIBILITY of the EQUIPMENT and or SYSTEM INSTALLATIONS REQUIREMENTS amp ENVIRONMENT CONTROL In order to minimize interference risks the following requirements Shall apply Cables shielding amp grounding 72 Instrumentarium Dental 200209 rev 3 200209 rev 3 7 Technical specifications All interconnect cables to peripheral devices must be shielded and properly grounded Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference Stacked components amp equipment The Orthopantomograph OP200 D with SmartPad accessory should not be used adjacent to or stacked with other equioment if adjacent or stacked use is necessary the Orthopantomograph OP200 D with SmartPad accessory should be observed to verify normal operation in the configuration in which it will be used Electrostatic discharges environment amp recommendations In order to reduce electrostatic discharge interference the floor material should be made of dissipative material versus the electrostatic charge

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