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1. BMD glcm2 Referen PT f 5 Bone O Tissue i Result Region BMD A l LI 1 033 Y Basic System 72 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 16 Print of Results and PACS Linkage Print out the acquired results Print out the information of spines and femurs by site through Information Check in analysis window after analyzing Also when clicking once the data in the list of subject measurement data the data of list is selected and when clicking the Print button the selected data is printed Information Spine Left Femur Right Femur Left Forearm Right Forearm It is possible to transmit subject s data easily using PACS if PACS linkage system is installed in the hospital Select the data in Information check and then click the Send PACS button Analysis T Patient Name HE4 year 2T Spine Data 2008 14 10 1 302 0 0081110 1 309 ign Farcarm Date BHE infor Spine Hile Femur 1 Aluht Femur and PACS linkage Send PACS Print Basic System 73 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 better products for better life did OsteoSys _ 1 www osteosys com 2 PrintDste 2008 10 16 Telephone
2. Document 88 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 3 Detailed Specifications of DEXXUM T Equipment Manufacturer OsteoSys Grade and ype 1 grade B ype msrumet Product size 2083 W x 1066 D x 1230H wem o oso S input voltage and frequency 100vac 240VAC 50H ook Powerconsmpion faoa o vaia period Semicpermanent oo AO a NE X ray generator Manufacturer ECOTRON Address 11F 1002 Hansin IT Tower 2 4 60 18 Gasan dong Geumcheon gu Seoul KOREA Maximum tube voltage rer Input voltage and frequency Lowest Current Time product Aluminum equivalent X ray tube Maximum tube voltage Document 89 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Descriptions Remarks Daily Check Phantom Manufacturer OsteoSys o o Model name DBMC SOOA o d 170 W x 50 D x 150 H re Performances O image sae cpa isos TT image sze Fema 120mm x 180mm J reproduct erse O Cr eas A ray radiator tme tin 25sec an Radiation dose below 10m Rem per examination 5m distance Residual radiation Below 1 mRem Sm distance ee O Use environment operating temperature above 15 below 00 suitable humidity fax O suitable ar pressure 700 1080 Hpa o impact Within Gino xa0 ee storage temperature range
3. Above 56 belowsoo storage humidity range fow 90 ooo Document 90 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 4 Installation Items List of DEXXUM T 1 Main frame of DEXXUM T Osteosys Equipment 2 Computer 1 Minimum requirements Samsung P4 Pentium processor 512MB Win XP 1GB hard drive capacity excluding DB Monitor 17 LCD Monitor Samsung Daily check a Color Per 500A Sros Eik ntom Communication 5mm cross cable Tio ET rement G3MJ 002A C alaa nt OCIO e a ARIS 13 Installation 1 Osteosys confirmation Document 91 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Warranty Thank you very much for using OsteoSys bone densitometer We notify that OsteoSys equipment has been developed and manufactured conforming to the law related to medical equipment OsteoSys will provide a repair of the product at OsteoSys own expense for any such failure and defects arising within a year of the original date of purchase or installation provided that such a defect which result from normal transportation and use and cannot be otherwise repaired e Repairs performed by OsteoSys are subject to charge to the purchaser at established service fee only in the following cases and at normal repair rates when received service after the warranty period 1 Wh
4. L2 on off L3 on off PN Dn RB wWwNnN P L4 on off Original Image O Color Image 1 ROI set It fixes or moves ROL 3 In case of fixation fixed region value appears when moving the value does not appear 2 Brush It is used to erase the factors causing trouble to subject s image or to include bone parts that were not captured within ROI ROI sort It does not detect ROI automatically but implements basic sort Auto ROL It is a function detecting ROI automatically by algorithm L1 on off It removes L1 region ROI from total results or adds when measuring spine Spine L2 on off It removes L2 region ROI from total results or adds when measuring spine L3 on off It removes L3 region ROI from total results or adds when measuring spine CON DOD WN A W 14 on off It removes L4 region ROI from total results or adds when measuring spine Basic System 65 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 Icons at the bottom of images are as follows OT ti C C CS 1 lt Original Image O Color Image 2 __sludy Comment gt Patient Comment 1 It determines image colors Black and white images or color images can be selected 2 Comments about subject s selection image can be inserted Basic System 66 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation
5. RT eS DVS NR Patient Information PRUETT S oscvszsnnicveserescazepascnsaes Doctor New3B 1_0425 NIME rer t Ethnicity BirthDste A 1 3 Hagh Weight lt Software Ver 1 0 0 0 gt Left Femur 2008 0401 igor Reference Neck 134 3 agon 121 2 75 14013 1 03 235 F largs 6 7 20 129 5 022 2 3 132 18101245 25 5 053 z oss 3 12 116 32 04 a 7 a Image not for diagnosis 26 30 4 50 GO 70 30 100 AAA WY Comment European Reference Population According to te publication of he Works Healy Organization NWO Normal A BMD resuk not more man 159 below he young adukt mean T gt 1 1 is considered normal Osteopeni2 A SMD result tral lies between 1 0 ana 2 550 below he young aduk mean 1 0 gt T gt 25 indicaties osteopenia Osteoporosis A BMD resur more Man 2 550 below ine young adut mean T lt 25 is classified as osteoporosis Normal T gt 10 Osteopenis 10 gt T gt 25 Osteoporosis T lt 25 ee Ocicosys www osteosys com hospital logo address and telephone numbers of hospital subject information results of multi site No 1 results of multi site No 2 gt Be NA comments Basic System 74 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Osteosy a i k PrintDete 2009 04 08 Telechora 02 20251650 P atent infarmati on F a ign are Birti ate iz
6. 1 The place with too much humidity 2 The place exposed to direct rays of sun 3 The place whose temperature is too much higher or too muc lower than adequate temperature for product 15 40 4 The place that can affect products due to impact or vibration 5 The place slanted too sharply 6 Storage of chemicals 7 The place where equipment generating a magnetic field is placed Be sure to check if main power is turned off and then connect when reinstalling equipment and authorizing AC power Otherwise the equipment can be damaged Equipment shall be placed on even ground Otherwise it can be moved to the direction to which carriage is slanted or HFG is slanted when power is turned off Basic System 29 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 3 Software Installation 1 PC LAN CARD Network IP Setting DEXXUM T communicates over LAN with PC Therefore it is necessary to set up specific IP address in general PC to communicate between PC and equipment Right click the network setting icon on the desktop b Click the properties c Click the Internet protocol TCP IP at the bottom of list under the general tap in the properties window and then click the properties d When the window appears as below enter the following in the column of IP address and click the OK e Click the OK and finish the sett
7. Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 3 Interruption of Operations of Equipment in Case of Emergency Evacuation In case of fire incidences of buildings or evacuations due to natural calamities follow the procedures below a Press the emergency switch and evacuate the subject by pushing arm in one direction b Separate the main switch or power and then promptly lower and evacuate the subject 4 Interruption of Operations of Equipment in Case of Fire a In case of fire flip the main switch down and separate the power connected to equipment b Lower the subject and promptly evacuate If the equipment is smoked or burned gas can be generated Osteosys recommends that you should have measures for fires Safety 15 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 5 Safety instructions on Measurement Assistant Measurement assistant made or approved by Osteosys shall be used for safety use of equipment Please note that if any errors of measurement value occur by using unapproved assistant users shall take the whole responsibility for that Safety 16 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Washing and Maintenance L Washing Of EUD MER ta Een A NO 18 2 Washing Or MONOS anta 19 3 Washing Or Ke DO MOS nad ae
8. have the point placed on the position meeting perpendicular line from outside the greater Trochanter Greater Trochanter Lesser Trochanter e When clicking ROI set button ROI is fixed and a triangle region is created Analysis C Patent Name HE 32 year Sy am AMO T Se a 2000 11 10 1 302 NA 2008 11 10 1 309 0 9 Le Free Date Boo TS 2008 11 10 0 884 0 5 Righi Femis Dale BHD TAL elginal image Siidy Comes 5 Dintrans Spine lbet Femur lFiuht Femur y US Trend SP gana pace E f The results are shown Basic System 69 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 15 Use of Brush Brush is used to eliminate factors affecting the measurement values of subject images or include removed parts on one s own into measurement values It is possible to adjust the regions of bone tissue neutral and artifact with appeared images a Click a subject s images in the list b Click the ROI set button when an image appears c Click the Brush d Select the check box of function to be used among Bone tissue neutral and artifact on the right menu e Select the Brush size f Click a certain area and paint it while rubbing with mouse clicked g Click the Result button after setting regions h Check the image if the painted regions are well reflected in the results i Click
9. 3 Warning label against laser pointer Laser radiation Do not stare into beam Ol Al oll SASHA DRA 2 Document 85 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 4 Equipment label Korean IIA E 1 SBS XA SES SE 2 ED DEXXUM T 3 HEHA ALLE LA A ASA Pet Pes 212 13 AAC A BHe 34 308 309 310 4 ee Al 1125 2 5 ABSA ARO xd Fa a Ho Bret OLS FSS 80 217 6 AJA 212 7 HARTE 8 ZZ 130 5Kg 9 ES Iset 10 HESY 72712 WHAT ad de ie MS El AOS 13 14 15 16 17 18 20 21 22 x lt Document 86 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 English OsteoSys O l td 3F 308 Byucksan Digitalvalley 3rd 212 13 Guro bong Guro Gu Seoul Korea MADE IN KOREA TEL 82 2 2025 1650 FAX 82 2 2025 2299 European Representative Medical Econet Gmbh Addr High 1 Park Mainstr 6c 6d D 45768 Marl Germ any TEL 49 2365 92 4357 0 FAX 49 2365 92 457 55 X ray Bone Densitometer POWER NETZ ALIMENTATION MODEL DEXXUM T 100 240Vac 50 60Hz S N 5 X ray Tube Voltage 70 99kV BA K mN 2008 CLASS I Equipment Filtration Total filtration 2 8mmAl please refer to the user manual X ray Tube Current 0 2 1 5mA Tube 0 8mmAl Samarium 2 0mmAl Take adequate precaution to prevent the possibility of any person
10. Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 10 Interruption of Bone Mineral Density Measurement If there is a situation needs canceling measurement immediately during bone mineral density measurement wrong measurements or patients complaints of inconvenience bone mineral density measurement shall be interrupted In case of emergency use the emergency switch and if it is not emergency situation normal termination is possible as follows a Click the Stop button while measuring b The following message appears 1 Go to Next Store the data being measured and go to the next scanning site 2 All measurement Stop and File isn t saved Stop the current measurement and do not save the data 3 Cancel Continue to measure 1 Go To Next 2 All Measurement Stop and File isn t Saved 3 Cancel Basic System 60 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 11 Re Scan Rescan is used to move scanning region into the region of interest without resetting during measurement when the subject s bones that are being measured are not within the region of interest Click the ReScan during measurement b Drag and click the middle of box within a red outline so that the regions to be measured may be exposed c The following display window appears 1 Move and scan Restart the scanning at the moved region 2
11. Repositioning Return to reset a region d Scan is restarted in the new region Measurement Y Patient Name 912 38 year Original Image Color Image Scan Speed Fast Analysis Picture A Rescan during Measurement Basic System 61 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Measurement Patient Name Test 0 year Original Image D Color Image Scan Speed Patient Measure Picture B Resetting of Regions Measurement Patient Name Test 0 year Current ma Image Mode Main menu Original Image Color Image Speed Move and Scan Patient Sah Ail Measure Analysis Repositioning Picture C Rescanning and Resetting of Regions Basic System 62 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 12 Description of Analysis Screen Subject s data which was measured are analyzed by doctors Analysis O Patient Name 213 38 year Spina Fa I Date BMD TSc F008 1 006 1 5 Leii Femur Date BMD 20080401 1 175 Righi Fermar Dale EMD 2008 04 01 1 172 BD 0 955 1 057 0 959 Original Image 2 Color Image 1 049 1 010 Study Comment Patient Comment l 0 992 1 007 1 007 1 021 Aight Forturm 1 004 Date BMD l
12. a gon Laai Taw Aralyz d Analys venon Avetage Thidraa Cate Masies 2004 4401 Tale Aral sed Ari vanor i A area nimme 1 hospital name 2 hospital address 3 subject s information 4 data information of No 1 site measurement 5 data information of No 2 site measurement Basic System 75 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 17 Print of Trend Trend shows the trend of subject s osteoporosis as a graph and BMD values Values by ROI region of each site as well as total BMD values can be printed a Select the site of interest in the first window of search condition b Select the region of interest in the second window of search condition c BMD values are indicated after sorted by date graph also indicates the data of measurement date as a diagram Trend i 4 2 3 5 6 Selection of Site Selection of ROI Region Print of BMD values of selected regions by date 1 2 3 4 Go to analysis window 5 trend graph 6 trend print Basic System 76 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 1 subject information 2 trend graph Basic System T User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 DEXXUM T Related Docu
13. and then click the Next MySOLcom Sign Up Login or create a new MySQL com account Please log in or select the option to create anew account O Create a new free MySQL com account If you do not yet have a MySQL com account select this option and complete the following three steps 0 Login to MySQL com Select this option if you already have a MySQL com account Please specify your login information below Email address Password cancel Basic System 34 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 g Click the Finish when database has been installed It automatically connects to optimal database setting and then click the Next Setup Wizard ES Wizard Completed Setup has finished installing MySQL Server 5 0 Click Finish to exit the wizard Configure the MySQL Server now Use this option to generate an optimized MySQL config file setup a Windows service running on a dedicated port and to set the password for the root account a n Wizard 153 Welcome to the MySQL Server Instance Configuration Wizard 1 0 8 The Configuration Wizard will allow you to configure the MySQL Server 5 0 server instance To Continue click Next h When MySQL server interface configuration window appears select the Standard Configuration and click the Next kant Pon E a oo eg
14. check phantom It is recommended to carry out daily test once a day for the more exact use of equipment a Click the Daily Test icon the second icon from the upper end of main screen of user program b There are red green indicators that show communication connection in right bottom of the screen In case of red stand by for a while until it turns to green Red communication between equipment and PC is in preparation Green equipment and PC is communicating with each other Daily Test I SP Daly Test Start AA f Basic System 45 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 c Click the Daily Test Start button at the bottom when it turns to green d Carriage of equipment starts to move to default position and laser pointer is turned on Do not stare directly at the laser pointer as it can cause serious damage to eyes Basic System 46 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO08 2F7430 MUL 01 e Place the daily test phantom with reference to picture A and B Place the phantom on a cross mark of laser point of equipment At this time have the cross mark indicated in phantom face inwards as shown in picture A and parallel inclined plane of phantom and a side of equipment OE og FIG A FIG B Basic System
15. cl 4 Cas MISIL Server instance Lontiquraton Yizaro Togt MySQL Server Instance Configuration Configure the MySQL Server 5 0 server instance e Please selecta configuration type ira Detailed Configuration Use this only on machines that do not already have a MySQL server installation This will use a general purpose configuration for the server that can be tuned manually Basic System 35 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO08 2F7430 MUL 01 I Select the Install As windows Service checkbox in the next window and press the Next MySQL Server Instance Configuration j Configure the MySQL Server 5 0 server instance Install As Windows Service TR This is the recommenbed way to run the MySQL server on Windows Service Mame MySQL m Launch the MySQL Server automatically L Include Bin Directory in Windows PATH Check this option to include the directory containing the server cient executables in the Windows PATH variable so they can be called from the command line essa cancel j Check the Mysql Secutiry Settings and insert the following in the blank and click the Next Current root Password SA Next root Password SA Confirm SA Select the checkbox of Enable root access from remote machine MySQL Server Instance Configuration Configure the MySQL Server 5 0 server i
16. for DEXSUM 3 The InstallShield Wizard will install DEeSsUM 3 on pour computer To continue click Next Basic System 31 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 e Click the Install and start the installation when the following window appears DEXAUM 3 InstallShield Wizard Ready to Install the Program The wizard i ready to begin installation Click Install to begin the installation If you Want to review or change any of your installation settings click Back Click Cancel to exit the wizard iale meld Install l Cancel f Finish the Installation DECCUM 1 InstallShield Wizard InstallShield Wizard Complete The InstallShield Wizard has successtully installed DEUM 3 Click Finish to exit the wizard Basic System 32 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 3 Installation of Database Install the database storing patient information a Go to the Database folder in the path where user program is installed Move to C WProgram filesWOsteosysWDEXXUM TWDatabase b Double click the Setup exe of database folder Welcome to the Setup Wizard for MySQL Server 5 0 The Setup Wizard will allow you to modify repair or remove MySQL Server 5 0 To continue dick Next c Press the
17. for safety or the case when instructions are needed Safety User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 2 Product Instructions The users of this equipment need knowledge of equipment and train for equipment use They shall read and understand the operation manual correctly and then operate the equipment according to the sequences Especially attention to the caution mark as it appears when there are directions or warnings in each partial item Installers and users of equipment shall take the responsibility for equipment operation according to the related laws and regulations of regions where the equipment is installed and operated Users shall take adequate education on adequate use of equipment and know well the use procedures by repetitive learning of manual periodically or non periodically It is recommended that users should simulate to provide against emergencies while training the equipment use repeatedly Safety User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 3 Software User programs and application programs for equipment use are protected by copyright Only authorized users of OsteoSys shall have rights to use software of this company Warning We shall not take the responsibility of death accidents by equipment or equipment dam
18. intarmatio 7 Spine Diet Femur O Alght Femur dera Y rT y E var a LY Trend E Send PACS AS Print AA ya Pm os Basic System 63 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO08 2F7430 MUL 01 Measured data are divided into BMD value and T score value in screen left according to the measurement date by region images appear in the middle of screen when clicking data Right top shows normal osteopenia osteoporosis by age matched T score distribution of analyzed subjects Right bottom shows bone mineral density value T score and Z core by ROI of subjects Data deletion button Spine Lu BMD g em2 Reference L1_L4 Date BHD T Sc Subject data 11 302 0 9 2008 11 10 1 309 0 9 T score graph Lett Femur Date BHD T Sc 2008 11 10 0 894 0 4 2008 11 10 0 884 0 5 OX ee Tissue Thickness 17 95 cm Right Femur _ Region BMD T Score Z Score L1 1 156 0 3 0 1 Date BMD T5c L2 1 376 1 4 1 0 a pai t TT Measurement value L1 L2 1 268 0 9 0 5 L1 L3 1 293 1 0 0 6 L1 L4 1 302 0 9 0 5 L2 L3 1 357 1 3 0 9 L2 L4 1 344 1 1 0 7 L3 L4 1 330 1 0 0 6 Basic System 64 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 Icons next to an image indicate the following ROI SET Brush ROI Line Sort Auto ROI L1 on off
19. set up Picture B the state the positions of spine and left femur are set up Picture C spine is being scanned with two positions set up j Scanning Measurement Patient Name 212 38 year O Original Image 9 Color Image Scan Speed Fast Normal O Stow k When measurement completes the screen automatically connects to analysis screen and Arm of equipment moves to the initial position Basic System 58 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Analysis O Patient Name 21 5 38 year Spine Dale BMD 2000 04 01 1 006 Liti Farmar Dale BHD 008 0401 1 175 Filth Formur Daie DHD 2000 0401 1 172 EMO TSeue Ebore 0 0155 ade ESA ag 1 057 Lott Paraarmn at Original image CU Calor image Shady Comment 13 Pateni Commend 1 E 1 Fl i 1 1 iir in iy hb u E h Fight Parean aia BMD Clintinmatia Seine O Left Femur Ci Fin Femair Trend E a Print Allow the subject to lower after equipment completely returns to the initial position for the safety of subject In case of One Scan when finishing one site it goes to the next site without messages At this time if the subject gets up while recognizing unconsciously the measurement has completed he can get hurt by moving Arm Basic System 59 User Manual Rev 1 01 English Version OsteoSys Co
20. 0 MUL 01 2 QC DB Back UP a Calibration Fix the setup on calibration e Interval of daily test Set up the calibration interval Image Files Path Appoint the folder where subject s images are to be stored value D WDTWimage b Database It is a setup related to database and fixed when network mode is used c Back up Back up File Path Appoint the folder where subject s data is to be backed up value D WD3N Backup d DICOM Set up the DICOM e Set up the IP Port Atitle suitable for each hospital Settings G C DB Backup Hospital Doctor Calibration Interval of Daily Test 1 w Dayis Image File Path C Program Files tfosteosys t DEXXUM Tttimage Database IP 127 D 0 1 DB Connection File Path Backup Back up File Path D Decum T Backup DICOM IP 192 168 20 1 Port 4006 ATitle PACSSERVER eer Basic System 41 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 3 Hospital Enter the hospital information The hospital information is shown on the top of subject s report paper a Hospital information e Hospital Name Enter the hospital name e Hospital Address Enter the hospital address e Hospital Telephone Enter the hospital telephone numbers Use LOGO It sets up if image file of hospital will be shown in report paper To add logo you can enter the path of hospital logo image file into path
21. 47 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 f If you intend to implement the daily check in the message window of Start or Cancel click the Start button to implement the daily check and click the Cancel button to cancel it Start or Cancel A Ok cS Cancel g Implement the daily check h If the massage of Daily Phantom does not pop up place the phantom in the exact position and measure it again i When the check is completed go to the initial position Daily check is implemented automatically until the equipment check is completed Be careful not to be injured due to carelessness during equipment operation as equipment may move Basic System 48 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 5 Personal Information Registration of Subjects Insert the personal information of subjects Exact values shall be entered as measurement mode varies according to the personal data of patients Add Register the subjects Search Search a subject satisfying the condition in the subject list Modify Modify the personal data of the selected subject Delete Delete the all the data of the selected subject E Add 2 search Es Modify Ml im Delete a Click the Measurement of user program b Register the new patient b
22. DEXXUM T DOC No OTO8 2F7430 MUL 01 13 Image Analysis SPINE It analyzes the subject s measured image of spine a Click the subject s measured spine images in the list on the left of the images b Press the ROI set button when images appear c Press the ROI set button again when ROI is captured normally as automatic ROI is set up d When ROI has not been captured normally capture the exact ROI by dragging 3 points in red line on images ROI needs resetting for exact examination of subjects whose spine is bent or pressed Middle point It is used to adjust top and bottom line Points on both sides It is used to adjust the inclination of lines e When it is difficult to adjust ROI with bare eyes use the histogram on the right of the images Histogram indicates image density in graph from above in case of high density the right of histogram is marked high and marked low for low density f Once clicking ROI set button ROI is fixed and calculated value appears as measurement value Analysis O Patent Mame 017 32 year fs Spee mi E Cate AMO 2008 11 10 1 402 008 1110 1 309 Le Fear Date BMD 2006 14 10 0 694 0 008 1110 0 804 Righi Famis Dale HHD Tore drue _ deiginal image Slidy Co 5 E E E T Ml Am Right Forearm Date AMD 4 informa Hm Sllatt Femur 2 Aight Femur a i m J 2 HR Trand i Basic System 67 User Manual Rev 1 01 E
23. Next and select the Typical Type TA i oc or y bea ee RON a E WH to f tr Ci P y ri co Pra Setup Type Choose the setup type that best suits your needs Please select a getup type 2 Typical z a Common program features will be installed Recommended for a a general use Complete All program features will be installed Requires the most disk ha Z z E space y a 0 Custom 4 Choose which program features you want installed and where they E H will be installed Recommended for advanced users fem P lt Back JL Next gt __ cancel Basic System 33 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 d Click the Install Ready to Install the Program The wizard is ready to begin installation If you want to review or change any of your installation settings dick Back Click Cancel to exit the wizard Current Settings Setup Type Typical Destination Folder CorProgram Files MySQL VM YSOL Server 5 0 lt Back Install Cancel e Database is being installed pal f Installing MySQL Server 5 0 The program features you selected are being installed Please wait while the Setup Wizard installs MySQL Server 5 0 This may take several minutes Status Cancel f When My SQL sign up window appears click the Skip Sign up
24. User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 DEXXUM I User Manual better products for better fife Osteosys User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 DEXXUM T User Manual Contents of User manual safety User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 User Manual Safety Precautions A IN ERE EEN 4 2 Safety nU seana Measures el dro 12 3 Washing and Maintenance estante id ria eat inte dns dois 17 safety Contents of User manual User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 General Use ocio eno oro he ASS onen RA 5 Ios A ES ac ied ELERS Ato tae 5 Zh o A E A AO 6 A O RD Se 7 2 POTE TIA SERIE OA Sax rer a a ee tet Dae pede hee acta 8 de DO Wa e arras ete de ae Etoo ea tec 9 A Personal Data Protection iaa ar al td dt te dae aes 9 5 Installation and Starting Of EQUIPIMONt on cscsssssssesssssssssecsssscsssessssscescesseccssseesssecsssecessnecen 10 6 Equipment Maintenance sosa dais 11 Contents of General Use safety User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 0O1 1 Notation Method of Manu
25. ages when persons who are not authorized to use the software programs use software or the damages occur by fabricating modifying illegally altering software programs without our company s permission 4 Personal Data Protection Personal information or figures about patients shall be protected under related laws Safety User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 5 Installation and Starting of Equipment Equipment installation and position change of installed equipment shall be based on related laws Please note that manufacturer seller installer importer and OsteoSys shall not take any responsibility for malfunction of equipment or measurement values in the following cases If the equipment was not used according to the directions of manual If the person who has not been authorized by our company performed the software install upgrade modification or sales after service If the service parts affecting equipment safety are not formal ones of our company If the environment of equipment installation and starting is out of standard Safety 10 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 6 Equipment Maintenance It is recommended to periodically perform examinations and maintenances of equipment and check up safety devices and equipme
26. al 1 Notation User manual and installation manual are described according to the following display method and consist of following notation methods Methods of sequence description symbolic notation and icon notation Description contents with sequences are described in alphabetical order a Contents of sequence No 1 b Contents of sequence No 2 c Contents of sequence No 3 Examples on the descriptions in manual are described in the box marked example Example a Place the patient on the bed of measurement equipment b Check if measurement points are within measurement range and place them in the exact position c Select yes no when display window of user program asks Will you move to standard position Additional descriptions are described as and they show the information to supplement brief information Information on important things or marks to be paid attention to among the manual descriptions SJ Contents to be noted concerning equipment use Contents to be known thoroughly concerning equipment use Pages to be referred to Safety User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO08 2F7430 MUL 01 2 Label Label 1 CAUTION warning label against laser radiation Staring directly at the outlet of laser radiation without protection equipment when the laser is turned on can cause serious damage to eyeb
27. alls Laser radiation Do not stare into beam Ol Al oll SASHA OPA 2 Label 2 CAUTION warning label against High voltage Users can be exposed to risks due to important equipments with high voltage Label 3 WARNING warning label against equipment movements When fingers are pinched between moving measurement arm of equipment and patient table accidents likely to occur HAND WARNING Keep hand off while running TiS 2q ia gA A Safety User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 3 Marks Nes N A oO gt o gt gt X ray is turned on It is the mark indicating X ray is being radiated at present It appears on monitor as well as controller of equipment during measurement or daily test X ray is turned off It is the mark indicating X ray is not being radiated It appears on monitor in case of stand by mode standing ready to be measured or measurement completion laser pointer It is a mark indicating the dangers associated with laser pointer Power is turned on It indicates power is turned on power on Power is turned off It indicates power is turned off power off Start mark It indicates X ray generation is in the preparation stage Communication state It indicates the communication state of equipment Caution It indicates when caution is needed
28. alysis completion One Scan has benefits of reducing patient waiting time and convenience of user equipment use with the steps of equipment setting 3 position position of the second area first region measurement second region measurement analysis completion when measuring more than two sites Basic System 52 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO08 2F7430 MUL 01 c Predict the measurement points of subject referring to the picture Right Femur Right Forearm y ee gt lt an we Yi i Yi 4 X FN y j 34 Spine AN p Y S Left Femur Left Forearm Spine Place the light of laser pointer on the navel and implement the measurement Femur Lower it about 15cm 20cm from the pelvis bones to leg direction and place the light of laser pointer in the middle of the thigh and scan femur Forearm Place the laser pointer in the middle of wrist and scan forearm d 2 Forearm does not support One Scan Basic System 53 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO08 2F7430 MUL 01 d Place the subject on equipment and fix the measurement assistant according to scanning regions When scanning a point of spine Outlines of Measurement Assistant Basic System 54 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designat
29. and femurs in pencil beam method and comparing them with collected data Scanning method Pencil beam Measurement points measuring time AP spine fast 1 min 25 sec normal 3min 12sec Femur Fast Lmin 5sec normal 1min 59sec Measurement method Non stop Scan AP Spine Dual Femur Simultaneous measurement of 3 points is possible Reference Data Korean standard data Reproducibility below 1 Modification of specific regions Users can add or delete bones and tissues to reduce the errors in case of BMD calculation of fracture implant or operating regions Auto ROI After measurement ROI region of interest are divided automatically Radiation dose below 10mRem per dose System linkage DICOM support Multi print function Results subject information and trend are printed Trend comparison comparison of trend data by region System Overview 22 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 2 Outlines of DEXXUM T OOF ee OY AN ae ee e SES Emergency switch Carriage bed wings top bed wings top folded front cover subject table bed wings bottom Operation switch for users 23 System Overview User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO08 2F7430 MUL 01 3 O SS oY E A O T e e pp W N e Outlines of User Op
30. as one might get injured due to a non fixed carriage Main switch AC power terminal and LAN cable terminal Positions of main switch power and LAN cable terminal Basic System 27 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Fixation block is fixed when turning anti clockwise direction y T Fixation block loosens when turning clockwise P Method for folding bed wings of equipment and methods for fixing and unfixing of fixation blocks Basic System 28 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 2 Equipment Installation The sequences of equipment installation are in reverse order of equipment movement Methods for equipment installation are as follows a Unpack a box and remove the carriage in equipment and HFG fixation block b Push the equipment and place it in re installation space c Have four parts of fixation block and ground to be in contact by turning it clockwise d Lift up the both wings of bed of DEXXUM T and fix them into the equipment e Plug it into AC power and connect LAN cable and PC f Turn on the main power installing or storing in unsuitable places can slow down performance q equipment or cause damage or abnormal operating Examples of unsuitable places for equipment installment or storing
31. column Settings QC DB Backup Hospital Doctor Hospital Information Hospital Name Hospital Ad in Resource e re Hospital Telep 20k in Ca Resou G r Report Mu IO sitemenu This informati Gil Calibration 1280 bmp ai DailyQC 1280 bmp iJ OsteoSys bmp File name Osteo Sys bmp Open Files of type 7 7 lao Cancel OK Cancel Apply Logo addition Basic System 42 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 4 Doctor It has password setting on doctors name telephone numbers fields and software use a Basic information e Name Enter the name of doctor in charge who uses it e Telephone Enter the telephone number of doctor in charge e Department Enter the department of doctor in charge b Password Change Change the password of doctor in charge being used e Current Password Enter the password of doctor in charge at present e New Password Enter the new password of doctor in charge at present to be changed e New password Confirmation Enter the new password one more time Settings AC DB Backup Hospital Doctor Mame PAHO A Telephone Basic Infornaiton Department Password Change Current Password New Password New Password Confimation 0 Basic System 43 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designatio
32. delete the subject data and personal information P Data deleted by users on their own cannot be restored Basic System 50 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 8 Search of Subject Data You can search a desired subject using the date of his birth name and ID as occasion demands and patient list according to search conditions is created Patient Search Name et Birth Date Gender YA Ok Cancel Basic System 51 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 9 Measurement of Bone Mineral Density a After entering subject information for bone mineral density measurement double click the subject in subject list or click the Measurement on the right with subject selected and then Measurement window appears Measurement 3 Patient Name 912 38 year O Original Image Color Image Scan Speed Fast b When scanning spine left femur and right femur can be selected and it is possible to scan by area and there is also one scan with which two or three regions can be scanned at a time What is One Scan Unlike the conventional method implemented in the process of equipment setting gt positioning one region measurement analysis gt equipment setting for other site positioning other region measurement an
33. elects the basic setup of subject gender e Menopause It is an option that selects if the subject experienced menopause when examining a female subject e Ethnicity It is an option that selects the basic set up of subject ethnicity e Print Preview Set the basic setup of print preview e Doctor It is selected when one person uses equipment and in this setting password is not asked when program starts O Forearm Scan It sets up the forearm measurement mode Spine It sets up if the representative value of spine shown in report will be printed Femur It sets up if the representative value of femur shown in report will be printed Scan Mode It sets up the use of T Scan Mode c Language 6 Language can be selected among English Korean German Spanish and Chinese Be sure to restart the program so that it might be applied Settings QC DB Backup Hospital Doctor Patient ID Mask Consecutive Numbers A alphabet 9 number E both seperator Default Settings Scan Site Full Auto Scan Gender Female G Male Spine 1 L4 v Menopause Yes O No Femur Neck e Ethnicity Mi ss Scan Mode T Scan Print Preview Use Print Preview Normal Doctor C The only one doctor use this program Language Language English Program must be restarted 03 TA Basic System 40 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F743
34. en product failures occur after the warranty period 2 Failures caused by natural calamities such as fire earthquake a stroke of lightning and flood 3 When product failures occur due to inadequate movement after installation and careless use 4 When product failures occur due to services by third parties other than OsteoSys appointed service agencies or OsteoSys designated engineers 5 When product failures occur due to disassembly and assembly of products on your own e If you require assistance please fill out the following form and send a fax to 82 2 2025 2299 or contact the nearby agencies stores or head office by calling the service line of 82 2 2025 1650 Please fill out the following and send it for prompt after sales service or tell us abnormal symptoms of equipment Model name serial No gt DEXXUM T Name of Installed hospital City Country Contact of Installed hospital Install date Abnormal symptoms OsteoSys Co Ltd Document 92 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Remarks Document 93
35. ents for safety reasons Please master the equipment operating method If users lean against the equipment arm or touch it during the stand by phase o measuring safety problems can occur in users or subjects Do not let subjects sit down or stand up while measuring Do not approach the moving arm when turning on the equipment in OFF state power is turned ON the equipment goes to the initial position automatically When abnormal operating or noise occurs during operation press the emergenc switch and contact related agencies or our company s AS team 2 Use of Emergency Switch When using emergency switch due to unexpected situation follow the procedures below a Press the emergency switch in case of emergency or abnormal operating b Push the arm in one direction with hands so that a subject may come down c Have the subject come down from the equipment and then change the main switch of equipment to off state d Return to the original state by pressing emergency switch once more e Take the necessary measures and turn on the main switch f Check if equipment operates Safety 13 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 1 Press it 2 Move it with hands so that a patient can come down HITA A A Safety 14 User Manual Rev 1 01 English Version OsteoSys Co Ltd
36. eration Switch 13 1 i ao SH _w i a 4 11 Fight go orearm K j 10 y N A 5 i lt P 6 8 7 Left Forearm Device ON When the power of DEXXUMT equipment is turned on Green LED is turned on Laser pointer ON LED When laser pointer is turned on red light is turned on Move Right It is a direction key making it move to the right hand direction of a subject Move Bottom It is a direction key making it move to the feet direction of a subject Move Top It is a direction key making it move to the head direction of a subject Move Left It is a direction key making it move to the left hand direction of a subject Left Forearm Select the left forearm of a subject Green LED is turned on Left Femu r Select the left femur of a subject Green LED is turned on Spine Select the spine of a subject Green LED is turned on Right Femur Select the right femur of a subject Green LED is turned on Right Forearm Select the right forearm of a subject Green LED is turned on Shutter Open When the shutter is opened yellow LED is turned on X ray ON It is in the course of X ray radiation and yellow red LED is turned on System Overview 24 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DEXXUM T Computer system 1 Main frame 2 LCD monitor 3 Printer Protective wall Domestic Measurement ass
37. ing Y General You can get IP settings assigned automatically if your network supports this capability Otherwise you need to ask your network administrator for the appropriate IP settings Obtain an F address automatically f Use the following IP address IP address Subnet mask Default gateway te Use the following UNS server addresses Prefered DNS server Altemate DNS server Advanced pre Basic System 30 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 2 Installation of User Program a Insert your CD into the PC b Click the My Computer icon and right click the drive where CD was inserted c Click the Explore and find out and click the Setup exe file when window appears Name Size Type Date Modified l data 1 cab 284KB WHE CAB IHE 2006 12 20 2 2 30 3 datal hdr 16KB InstallShield Cabine 2006 12 20 23 2 30 data 2 cab 8 374KB WE CAB IHE 2006 12 20 23 2 30 Gl engine32 cab 449KB HEN cas IHE 2006 12 20 23 1 44 layout bin 1KB BIN File 2006 12 20 23 2 30 setup exe 115KB Application 2003 11 10 PS 7 55 E setup ibt 367KB IBT File 2006 12 20 2 2 30 setup ini 1KB Configuration Settings 2006 12 20 23 2 30 E setup inx 177KB InstallShield Compil 2006 12 20 2 2 30 d Click the Next when the following window appears Welcome to the InstallShield Wizard
38. ion DEXXUM T DOC No OT08 2F7430 MUL 01 tS Fixation of feet when measuring a region of femur or in case of One Scan Basic System 55 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO08 2F7430 MUL 01 e When pressing the Positioning button in measurement window it stands by in the initial position for 5 minutes The message said it will go to Default position appears f Check if subject has injury risk by equipment and click the Yes button Yes gt automatically go to Default position No gt manual movement using op control switch g When having moved to Default position laser pointer is turned on and laser pointer LED of user operation switch is turned on h Go to the proper position where you can select spine left femur right femur of subject by pressing Top Bottom Left Right keys and operating Arm of user operation switch Press the Select switch of appropriate site Once pressing the Select key appropriate coordinates are stored in equipment If you want One Scan go to another measurement points and set up the appropriate site once again When coordinates are set up in each site LED green is turned On If pressing Select switch of appropriate site one time LED green is turned on and present position is stored when pressing once more LED green is turned off and the stored position inf
39. istant tripod Daily check Phantom User manual Service manual Power cable LAN cable for communication Software installation CD Supplies A4 paper printer ink 4 DEXXUM T System Configuration 25 DOC No OTO08 2F7430 MUL 01 System Overview User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Basic Installation Method of DEXXUM T L EQUIPIMent MOVE men tii ais adi ia 27 2 TECHN ment as ala Ona R cda 29 SO Ware asta 30 1 PCLAN CARD NETWORK IP setting 2 Installation of User Program 3 Installation and Setting of Database Contents of Basic installation Method Basic System 26 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 1 Equipment Movement DEXXUM T has 4 wheels and a fixed supporter in the lower part of equipment Methods for equipment movement are as follows a b 2o N Turn off the main power Separate the AC power connector and LAN cable of PC from equipment Draw and lower the both wings of bed of DEXXUM T Leave a space between the supporter and floor by turning the fixed supporter anticlockwise Push the equipment using wheels When moving DEXXUM T leaned or lifted carriage shall be protected for equipment protection In this case contact our AS team or agencies Be especially careful when moving equipment
40. l Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 C Patient Dose Amount Graph 83KV 0 4mA Unit mR Patient Dose 83kV 0 4mA estimated Vs Measured 35 gt 25 zZ E 2 ESS 2 mR a a 187 5ec 1 675 mR AA 15 _ e i 119 sec 1 066 mR 85 sec 0 766 MR 65sec 0 589 mR 05 p i gt A E 0 0 50 100 150 200 250 300 350 400 TIME Sec D Patient Dose Amount Graph 83KV 0 4mA Unit uSv Patient Dose 83kV0 4mA estimated Vs Measured 35 30 25 _ aa i 20 p 2 E uSV A ias SY 83 0 4mA 10 p 119 sec 9 33816 uSv 85 58c 6 71016 USV s 5isec 5 15984 us 1 l I I I S S S 0 0 50 100 150 200 250 300 350 400 TIME Sec Related Document 83 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 2 Label Label positions of equipment are as follows Document 84 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 1 Warning label against pinched fingers HAND WARNING Keep hand off while running Tis 2q ia gA A 2 Label for daily check phantom DEXXUM T Device PHANTOM MODEL 07108900001 S N BMD aqua 2 OsteoSys Manufacturer Osteosyvs CO LTO SF 308 Byucksan Digitalvalley3 212 13 Guro Dong Guro 44 Seoul Korea
41. ments 1 Documents Related to Radiation Of DEXXUM Tinoccncincionicnconioninnnnnrnncrnenarererarasnss 79 DPAluminum EQUIV AICI E Er eee eee 79 2 Radiation Amount of DEXXUM T Leaked Outside c oocccococonccococoncnonocncnncnononocnononococnonocnono 80 E OS Cet Mae ta tg Tal sata Na a ete 81 2y HEA Sates caret O E A ase eat eacee ats as ese temp eeee tetas ne 84 3 Detailed Specifications of DEXXUM J isanoaacuinivacsiasaniaiicunuusancimetumandaus 89 4 List of Installation Items Of DEXXUM T wiiccccccccsssessssessessesssssssessesseessssseestessestesteseenen 91 Be MA ios 92 6s RENARE saca jacais 93 Contents of Related Documents Document 78 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 1 Documents Related to Radiation of DEXXUM T 1 Aluminum Equivalent Aluminum Equivalent of DEXXUM T X ray tube inner filtration 0 8mmAL Total Filtration Equivalence 2 8mmAL Related Document 79 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 2 Radiation Amount Leaked Outside The amount of leaked radiation of DEXXUM T is as follows Value of measured scatter radiation usvw hr TE TT q A aia Related Document 80 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 3 Patient D
42. n DEXXUM T DOC No OTO8 2F7430 MUL 01 3 Registration of Doctors User program of DEXXUM T reports patient records by setting separate password by doctor when many doctors use it When one doctor uses it refer to Doctor column of configuration at page 35 a Doctor Selection Menu O Select If there are many doctors click a doctor and Select O New It is used when a new doctor is added Delete It is used to delete the name of doctor and it can be moved to another doctor database or deleted completely if there is patient data in database e Exit It is selected when the user forgot his password or finished the program b Doctor select e Click the Select button after selecting a doctor or double click after selection c Insertion of Password e Enter the password when password window appears and press OK Doctor Selection Doctor Selection Name AGE Password Static Password A A ok 9 Cancel Select A New f Delete ad Exit The only one doctor use this program _ The only one doctor use this program If you forget your password contact AS center of our company for protection of personal information Basic System 44 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 4 Daily Test DEXXUM T requires daily check according to the intervals set up in configuration using daily
43. n 19 Safety Contents of Maintenance 17 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 1 Washing of Equipment Warning Turn off the main switch before washing Separate the AC power cable from power source Notice Do not eject the spray type cleansing solution or cleansing solution in a spray container onto equipment If spray type cleansing solution or cleansing solution is ejected to equipment it has a very high possibility to cause damage to electronic machines within equipment Be sure that cleansing solution might not be flowed into the equipment inside Contact areas between patients and equipment shall be kept clean When cleaning cover of equipment wipe it using soft cloth dipped in cleansing solution mixed with water or neutral detergents Sprinkling water on equipment itself or soaking the equipment in water can cause damage it Do not use solvent or paint remover Safety 18 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 2 Washing of Monitors Notice When cleaning monitors do not use acid or alkaline detergents It can cause damage on monitor surface When cleaning monitors brush the dust off with a soft brush or wipe it off with a soft cloth dipped in a neutral detergent when need wiping It is recommended to wipe
44. n completed Basic System 37 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 The Directions of DEXXUM T Program Te o rare ell ersten egern dede 39 A TAF an PEE 39 Se REGIST AE OOF DOTON fenna eee Ea eN 44 As Daly Elec dao 45 5 Registration of Personal Information of SUDjeCtS ociniciniconononnmmmmmmm 49 6 Modification of Personal Information of Subjects oconocccecnccncinnnnmmm 50 7 Modification of Personal Information of Subjects onononcinionionninninnmmmm 50 O Searching Or subject Data oa adoos 51 9 Measurement of Bone Mineral Density cccccesssssssssssessssssssssssseessessssesssesseseseesneens 52 10 Interruption of Bone Mineral Density Measurement uc cccccesccsesessessesseeseeseeseeseseees 60 F RES ERNE tian O eet ae A te 61 12 Descriptions Of Analysis Sareen axis anale renees else ae 63 13 Analyse Ol SONS Images sica aia 67 14 Analysis of Femur Maestras 68 T5 UEO BI gore once nee E nnn On Pane Tm ORAL CU TED 70 16 Print of Results and PACS Linkage miensstiadn dali dai 73 F ES O o este ieee ere auton 76 Contents of The Direction of User Program Basic System 38 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 1 Starting of Program Turn on the equipment start the user program by clicking the DEXXUM T icon in the desktop Power LED of
45. nglish Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 14 Image Analysis Femur It analyzes the subject s measured images of femur Refer to 13 image analysis spine as the analysis methods are basically the same as those a If ROI of femur has not been captured automatically practice the following Press the ROI set button b Drag the red box to capture ROI of femur and place the pointer in the middle of the box in the Neck c Have the inclinations of Neck and rectangle box be perpendicular by adjusting inclinations with pointer outside the square MENAJE 92 38 year cs Date BMD T Sc 2008 04 01 1 007 1 5 BMD g cm2 Reference Neck 1 24 1 21 Lett Femur Date BMD 2008 04 01 1 175 Right Femur Date BMD E mee ie T AR Region BMD T Score Z Score Y A O Neck 1 175 2 1 4 _ Troch 1 033 Original Image O Color Image Shaft 1 197 z Total 1 146 Study Comment gt Patient Comment Sa Right Forearm A Date BMD Left Forearm Dl Informatio Spine TI MeftFemur Right Femur tel Faron jist Farsar Analysis Basic System 68 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 d Place the pointer that can be dragged out of square on the same line with bottom right of lessor Trochanter
46. nstance gt Modify Security Settings 9 Current root password Enter the current password roat New root password Enter the root password Confirm FE Retype the password Enable root access from remote machines Ereate An Anonymous Account This option will create an anonymous account on this server Please note that this can lead to an insecure system m conca Basic System 36 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 k Configuration of database has been finished Click the My computer icon on the desktop and enter the folder path of C WProgram filesWOsteosysWDEXXUM T m Execute the DBsetting bat file een aes dd AE ES Hospital Ist 1KB LST File 2006 12 20 2S 2 31 vert tact iKB LST File 2002 01 10 22 3 57 1KB MS DOS Batch File 2006 12 20 A 1 Sib SOL dl 212KB Application Extension 2001 02 01 SA 9 49 Neo DEXXUM exe 8 113KB Application 2006 12 20 13 1 25 P DESetting bat n Once DBsettings bat file is executed C WWindowsWSystem32WCMD exe window appears Insert the SA when the item of Enter password appears C Documents and SettingsHAdministratorWfy Documents DIN Added Ci Program File SAYS QLYNYSQL Server 5 8uthin HProgram Files MySQLHNySQL Server 5 64bindmysql u root p BiCreateDB dmin txt Jo password o Automatic file is executed and installation has bee
47. nt for the safety of equipment users patients and the third The details about examination and maintenance of equipment are indicated in contents of equipment operating procedure in manual and it is recommended to periodically perform procedures on examination and maintenance N When you need services please contact our AS team or local agencies Contact number of Osteosys A S dept 82 2 2025 1663 4 1650 Periodical examination and required specific examination can be added according to the related laws Safety 11 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Safety in Use and Measures 1 Equipment Opera HON sacra E toid s 13 2 Use of EMeErGeEncy SWITCH aanisaa 13 3 Interruption of Operations of Equipment in Case of Emergency Evacuation 15 4 Interruption of Operations of Equipment in Case Of Fire sescsseseseseesesesteseeseens 15 5 Safety instructions on Measurement ASSISTANT ooccninicicccncononnononnonoconnrononnononocnronrar crono nerne 16 Contents of Safety in Use and Measure Safety 12 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 1 Equipment Operation DEXXUM T is equipment that generates X ray and measures the spine and femur of patients using the movements by motor drive Subjects and patients need to be careful of motor movem
48. ormation is deleted In case of One Scan LED of selected SW is turned on while standing by the measurement and it informs which site is being measured while flickering when set up site is scanned Basic System 56 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 N a A Scanning areas It means the measurable areas with equipment Navel When measuring spine set laser pointer to a navel Equipment automatically lowers about 4cm for measuring and scans it Right femur Lower it about 15cm 20cm from a right pelvis level and set laser pointer to the middle of femur to measure right femur Left femur Lower it about 15cm 20cm from a left pelvis level and set laser pointer to the middle of femur to measure left femur Measurement assistant It bends inwards and fixes feet so that femur neck part may not overlap the surrounding textures and bones when measuring femur i Click the Measure Start button of user program and it starts scanning at the appointed position after measurement points are set up Basic System User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Z FA F Nye r yyer J ER oe Yi le x Yi ROCES i 7 SV AY po E A N e AN Y CKY Lt R Ah Picture B Picture C Picture A Picture A the state position is not
49. ose Amount Table mR Measured Scan Scan Measured tube tube p Dose Ratio mAs Site speed Mode Time current voltage mR Spine Es Thin 65 sec 0 4 mA 0 589 speed Time current voltage uSv Fast Standard Normal Standard 6 A 4 6 280 5 71 832 Patient Dose Amount in Normal Operation 2 3 127 5 32 7624 04 52 122 16 as Standard 65sec sec 15 MA mA In sec Am Related Document 81 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 A Patient Dose Amount Graph 83KV 1 5mA Unit mR Patient Dose 83kV 1 5mA Estimated Vs Measured 342580 14 94mR AA Xx E 10 2 4 mA 83kV 1 5mA A 187 ec E 2mR 6 J DSE r 119sec 5 14mR a B5set 3 74mR OSSEC 2 885mMR 2 pS 0 1 EU en 0 50 100 150 200 250 300 350 400 TIME Sec B Patient Dose Amount Graph 83KV 1 5mA Unit uSv Patient Dose 83kV 1 5mA estimated Vs Measured 180 160 PA 140 __ 344 sec 130 8744 USV 120 pF p A 100 F e gt e a 2 2 uSv a s gt YAA AAA 83K mA 187 sec 71 832 uSv 60 HH m ff LI fS Sl 1364e0 52 122 uSw 119 sec 45 0264 uSv 40 A A nn 85 sec 32 7624 uSv 55 sec 25 2726 uSv 20 es 0 0 50 100 150 200 250 300 350 400 TIME Sec Related Document 82 User Manual Rev 1 01 English Version OsteoSys Co Ltd Mode
50. s Carelessly exposing themselves or other to radiation WARNING To avoid electrical shock do not open the cabinet Refer serving to qualified personnel only WARNUNG Da Gefahr eines elektrischen Schlags besteht dart das Gehause nicht geoffnet werden Uberlassen Sie Wartungsarbeiten stets einem Fachmann ATTENTION Four eviter tout risque d electrocution ne pas ouvrir le coffret Confier entretien uniquement a un personnel qualifie CAUTION Federal Law restricts this device to sale by of on the order of physician 5 Label for subject table DEXXUM T Patient Table MODEL H2AY 002A S N DD MMZYY 72008 OsteoSys Co Ltd MANUPRACIO RER OsteoSys Co Lid 3F 306 Byucksan Digitalvalle VI 2712 13 Guro Dong Guro Gu Seoul Korea TEL 82 2 2025 1650 FAX 82 2 2025 2299 Document 87 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 6 Label for X ray generator X ray Generator Model EMB 0165 Manufacture Ecotron Co Ltd Serial No Mtg Date Line input Power 100 240Vac Single Phase 50 60Hz Max Output Power 165W Inherent Filtration 2 0 mm Al Rating 70 99kV 0 2 1 5mA Continuous X ray TUBE HEAD Model DF 151SBR Manufacture TOSHIBA Focal spot Large 1 5mm Small 0 5mm Operating Tube Voltage 40 110kV Anode Heat Storage Capacity 35 5 kJ Target Angle 16 degrees Inherent Filtration At least 0 8mm Al
51. the Reset button if the painting fails It returns to original image of patients Jj Click the Cancel button if you want to cancel the region setting during region setting When Brush function is applied to original images BMD T score values are affected directly Therefore be sure to consider carefully when using Brush function Basic System 70 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 Bone Region Labeling It is used when a bone to be calculated has not been captured in ROI regions BMD g cm2 Reference g 0 Tissue OC Neutral Els O Artifact L2 Brush Size P 5x1 Lay C x2 La i 03 Reset Cancel Region BMD wa 1 0 928 Tissue Region Labeling It is used when setting tissues on both sides of bone BMD gicem2 Referen Neutral L1 r e fl i O Artifact La T Brush Size 5x1 L3 ta Region BMD 1 0 928 Basic System 71 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 Neutral Region Labeling It is used when setting the regions excluded from BMD calculation Referen A A Brush Size xi C x2 C x3 Artifact Region Labeling It is used when removing foreign substances on images
52. the surface of monitors with a soft cloth or use a cleaner for monitor screens 3 Washing of Keyboards When cleaning keyboards brush the dust off with a soft brush or wipe them off with a soft cloth dipped in a neutral detergent when need wiping Safety 19 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 DEXXUM T User Manual 1 Product Introduction OF DEXXUM Tissot 21 2 Basic Installation Method of DEXXUM Teeniooniciciccnccncnnononccnconanoncncncnnanonononcnnonononononnnnanononon co nenananononos 26 3 Instructions of DEXXUM T Program lisas 24 4 Documents Related to DEXXUM secs te te alee cla daira aid 78 Contents of User Manual System Overview 20 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 DEXXUM T Product Introduction Vs Product DES EFP HON oo rr dana coord 22 Di OMNES ORD XXUM nit ide EE 24 3 System Configuration of DEXXUM Toa 25 Contents of DEXXUM T introduction System Overview 21 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO8 2F7430 MUL 01 1 Product Description Osteosys DEXXUM T is an osteoporosis diagnostic using x ray It uses x rays having two different energies and calculates the value of bone mineral density by analyzing images acquired from scanning of spines
53. user operation switch is turned on and equipment arm Agus to the initial position if it is not there te ioh Of X UM NEGRI Tali Calibration ES f 7 Database nfigrati S Configration 4 OSTOSYS 2 Configuration Configuration shall be done once at first after installation Configuration is done in a user program for equipment use Select the checkbox according to the descriptions by each item 1 Settings Tap a Patient ID Mask e Consecutive number Give ID number serially from 1 O User definition Blank Insert A Letters from A to Z can be inserted Other characters cannot be inserted Insert 9 Numbers from 0 to 9 can be inserted Letters other than numbers cannot be inserted Insert Both alphabetical letters and numbers can be inserted regardless of digit number If ID 8AD123 shall be inserted gt OAA999 or HHHHHE or H HHHHHHHH can be used regardless of digit number Basic System 39 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OTO08 2F7430 MUL 01 O Resident registration number of Korea Republic b Default Settings O Scan Site It is an option that sets up more than two regions Spine Left Femur Right Femur in continuous mode Once it is set up position is set up at a time without selecting position by site before finishing using one scan method O Gender It is an option that s
54. y clicking Add button at the bottom of subject list c Register the information when Patient New window pops up Patient ID Enter the chart number or subject ID Name Enter the name of the subject Birth data Enter the date of the subject s birth Gender Enter the gender of the subject Ethnicity Enter the ethnicity of the subject Height Enter the height of the subject unit cm Weight Enter the weight of the subject unit kg Menopause When the subject is a female select if she has experienced menopause d Click OK when having finished inserting Patient New Patient information Patent ID Mask Consecuthe Numbers PalienilD Hamr Dinh Dati I i Gender Female Male Doctor Ethnicity Korean bl Helght Cm Weight Kg Menoparse Yes W Nin Comment ET on Q Cancel Basic System 49 User Manual Rev 1 01 English Version OsteoSys Co Ltd Model Designation DEXXUM T DOC No OT08 2F7430 MUL 01 6 Modification of Subject Personal Information Select a subject and click the Modify button to modify the personal information of the subject Patient Modify Patient Information Patient ID Mask Consecutive Numbers PatientlD Name MES BirthDate 1970 Im 40 Gender O Female Male Doctor Ethnicity Korean v Height 174 0 Cm Weight 68 0 Kg Menopause Comment A Ok x Cancel 7 Deletion of Subject Data and Personal Information Select a subject and click the Delete button to

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