3. Using EXA-3000… - Health Fit & Sport
Contents
1. 60 5 Specifications amp Software Upgrades 65 Mss 8 ss 66 5 2 Software Uperades oe esse 69 6 Product WaEralily ooa Reldo Cabot a bee erede ea sdc e Ria asia 70 Chapter 1 Introduction 1 1 General Product Information Osteoporosis 1s one of the serious diseases This device is a bone densitometer which estimates a bone mineral density of the forearm and calcaneus by X ray It takes about 10 seconds to measure the density and to display that image on the monitor To ensure safe operation and long term performance stability it 1s essential that you fully understand the functions operating and maintenance instructions reading this manual before operating the equipment X Features and Cautions This device is an X ray bone densitometer which has 1 5 precision error The equipment must be operated only by or under supervision of a qualified person When you give the appropriate commands in EXA3000 software X rays are generated A collimator directs the X ray through the Patient s forearm or calcaneus to the detector where the X ray screen and CCD charge coupled device camera detect the radiation The detected radiation image is treated by EXA algorithm EXA 3000 software calculates the ROI Region of Interest and displays the patient s bone density All operators must understand the potential hazards in the use of medic2. Checking points after use of product A Make sure to clean the product so that use Deactivate the product and turn the power off in order B Do not pull the power cord forcibly C Comply with followings to keep the product properly D Avoid places that can wet the product 2 Avoid places where air pressure temperature and humidity drastically change and where there are direct ray of sun dirt salt and sulfur 3 Do not lean shake or rock the product D Clean accessories after use E Make sure to clean the product so that users can use it immediately If the product is out of order do not try to repair it for yourself Do not modify use the product If any modification is desired ask OsteoSys or its authorized dealer for this service Check maintenance and repair Cautions in times of transportation of cart If you have to move the cart on incline floor you should detach the product from the cart so that the product does not slip to the ground 1 0 Environmental protection If the products are at the end of their useful lives do not dispose them at your option Contact OsteoSys or its authorized dealer for this service Others Read the user s instructions carefully and use the product properly Chapter 5 Specifications amp Software Updates 5 1 Specifications 5 2 Software Updates 5 1 Specifications General Scanning Unit Input Voltage AC 100V 240V Free Voltage Single Phase Preci
3. Fax 815 338 9452 E mail info superiorxraytube com Manufacturer Address Chapter 6 Product Warranty 9 Scope and Period of Warranty 1 HFS Ltd guarantees all new products against faults in materials or workmanship for a period of one year from date of shipment to purchaser OsteoSys Co Ltd will as sole and exclusive remedy at no charge replace any such defective unit returned to its service designated warranty period 2 This warranty applies only to failures from operating the product under conditions for which it was designed Warranted product is to be used only for the intended and labeled indications presented in the literature accompanying the product 3 HES Ltd will charge service fees in following cases If the product is out of order after the warranty period expires If the product is out of order due to natural disasters such as fire flood windstorm hail lightning and earthquake If the product is out of order due to improper transportation after installation and careless use If the product is out of order due to improper repair or renovation by someone other than service personnel of the company 5 Cosmetic defects or deterioration will not be refinished or replaced The costs of replacement of fuses are not covered 6 HFS Ltd will not be responsible for any loss damage or injury resulting from delay in rendering service under this warranty 7 HFS Ltd wil
4. 4 23 3 Storage 1 Unplug the power cord 2 Dust on the product can damage the system After use make sure to cover it with vinyl cover Daily 7 storage 4 2 1 Cleaning Unplug the power cord Do not detach cable of the device connected to plug to prevent dust from coming inside Place cable near the product or at an empty area in its front Put cover on the product to avoid dust Keep the product according to instructions described in 2 2 Installation of EXA 3000 2 2 Installation of EXA 3000 Storage for a long time of period 4 3 Sate Use of EXA 3000 4 3 1 Safety Rules The followings are instructions for safe use of the product Make sure to comply with the instructions when you activate the system Refer to 4 3 2 Caution related to electronic medical equipment a 4 3 2 Cautions Related to Use of Electronic Medical Equipment CAUTION CAUTION Do not open it because there are some high tension components inside It might cause serious danger Check if the cable coating is not damaged before turning on the system to prevent electric shock or leakage of electricity If it 1s damaged or broken immediately contact an agency Do not share the power outlet with other products If you share the outlet it will affect the product Read user s instructions carefully before using the product Place the user s instructions at a designated place so that users can read it anytime they ne
5. Densitometry RX EXA 3000 TD Health Fit amp Spori Thank you for purchasing EXA 3000 X ray Bone Densitometer To ensure safe operation and long term performance stability it 1s essential that you fully understand the functions and operating maintenance instructions by reading this manual before operating the equipment Particular attention must be paid to all warnings cautions and notes incorporated herein Incorrect operation or failure of the user to maintain the equipment relieves the manufacturer or his agent of the system s noncompliance with specifications or of responsibility for any damage or injury The following conventions are used throughout the manual to denote information of special emphasis WARNING Warning is used to indicate the presence of hazard that can cause severe personal injury death or substantial property damage if the warning is ignored CAUTION Caution 1s used to indicate the presence of hazard that will or can minor personal injury and property damage if the caution is ignored Note is used to notify the user of installation operation or maintenance information that 1s important but not hazard related The symbols which are shown in this manual The noticed information which should be concerned with explanation in this manual The noticed information when the device is operated The reference page or section S zi ts The symbols which are sh
6. Button InstallShield Wizard Choose Destination Location Select folder where Setup will install files Setup wall install ER24 3000_ 3 in the following folder To install to this folder click Next To install to a different folder click Browse and select another folder Destination Folder XPragram Files OsteoSys Eo4 S000_ 72 Browse InstallShield z Back Cancel 6 The installation starts Installshield Wizard Ss d Setup Status E 4 3000_ V3 Setup is performing the requested operations Be YJJJJYIJYJ JG InetallS hield 7 The installation is done InstallShield Wizard InstallS hield Wizard Complete Setup has finished installing EXA 3000 V3 on your computer Back Finish Lancel 3 2 3 Using Program 3 2 3 0 USB Driver installation 3 CAUTION If OS is Window Vista or Window7 USB Driver is not installed automatically Install USB Driver as following procedure 1 Execute EXA 3000 s install CD 2 USB Driver folder in CD gt New Device Ex If CD path is E E USB Driver New Device 3 If Vista A Move to New Device Vista folder double click Osteosys Exa3k 1 0 810 23316 release exe to execute it Ex If Driver version is 1 0 810 23316 the name of file is Osteosys Exa3k 1 0 810 23316 release exe 4 If Window7 A Move to USB Driver Window7 folder double click Osteosys E3K versionNo release exe to execute it Ex If Driver versio
7. and comment if you click the FP Print Calcaneus Result Update button in the result screen the message box Result Update inquiring about whether to update the information surely appears If you click the OK button the relevant history is updated 3 2 3 6 Calibration of EXA 3000 1 To operate Calibration put QC Phantom inside of the slot At that time please push Heel Positioner to the end as if you measure the forearem to place QC Phantom well 2 There is the white line on QC Phantom Please fit the white line on QC Phantom with the line on the Positioner and press on the right side the detector Caution Do not use this phantom for measurement Only Daily Test lt QC Phantom gt gt EP VC MM 3 To execute Daily Test the system click the Daily Test button in the default screen Then the Daily Test screen appears When you click the Daily Test Start button in this screen X ray radiates from the X ray source Dailytest 2008 05 20 2009 08 26 4 When X ray radiates the word on the Daily Test Start button is changed into Daily Test Stop In case of emergency click this button and if you click the button X ray radiation stops In the normal condition the message box Daily Test Success appears as shown below with an alarm sound after progressing Daily Test and if you c
8. computer Keyboard Direct contact with water or detergent can damage the key board Remove paper from the printer and dust the printer with a soft brush carefully If there is strong stain on the printer soak a clean and soft cloth with neutral detergent diluted with water in about a ratio of 5 to 1 and wring water from the cloth and wipe Printer out dust And then clean the stained a with dry cloth Cover the printer with printer cover to avoid water User s instructions for printer Cleaning Unplug the product and dust the device with a soft brush carefully Disinfection The Hand Guide and Supporter which the patient touches should be cleaned by wiping the part with a l T water wringed clean and soft cloth Device soaked with neutral detergent diluted in water with a ratio of 5 or 6 to 1 After this procedure clean the stained area with a dry piece of cloth Make sure not to put water or detergent on the device directly because it can cause fatal damage in the electric circuit contained inside 4 2 2 Stockpile and Replacement of Articles f Make sure to keep following articles of consumption all the time 2 1 5 Articles List Specifications Printing Use white A4 paper paper Refer to user s instructions for details Replace ink cartridge with a new cartridge if the printed text or picture is not vivid enough User s Instructions for Printer Ink cartridge
9. 0 wdb a 4 strator File name wdb Open Files of type Whole DB wdb Cancel VERE 3 Clear If you click this button the message box Surely clear doctor inquiring whether to delete the user surely appears If you click the OK button you can clear all users DB Backup Database shall be saved for backup Database Clear Database shall be cleared t can be affects other doctor s database Only be used by administrator 4 Recover If you click this button you can recover all users DB All records related the DB are written in this field After selecting the record and clicking the OK button in this screen the DB is recovered Recover No Backuped Date Doctor Name Operation File Path 1 20081201 11 10 Test Retrieve C WProgram FilesHOsteoSysWEXA 3000 V3WBackupMWAuto 2 20081201 11 09 Test Recover C Program FilesHOsteoSysWEXA 3000 V3WBackuptHAuto 3 20081118 16 31 Test Clear C Program FilesWHOsteoSysWEXA 3000 V3WBackupWAuto 4 20081118 15 37 Test Recover C Program FilesHOsteoSysWEXA 3000 V3WHBackupWAuto 5 20081118 15 36 Test Clear C Program FilesWHOsteoSysWEXA 3000 V3WHBackupWAuto amp 20081118 15 36 Test Backup C Program FilesHosteosysWEXA 3000 V3WHBackupWE3K 7 20080701 13 56 Test Retrieve C Program FilesHOsteoSysWEXA 3000 V3WBackupWAuto 3 2 3 8 Configuration of Environment 1 I
10. 2 96 P aC c 0 94 Age Matched Z Ratio 112 02 WHO T Score classification Score gt 1 Normal 1 gt T Score 2 5 Osteopenis 2 5 T 8core gt 3 5 Osteoporosis 3 5 gt T Score Severe Osteoporosis Doctor Name Test OsteoSys www osteosys com 3 2 3 4 Revision amp Deletion of Patient s Information 1 If you want to revise the registered patients information select a desired patient using the mouse and click the Info Change button in the Patient List screen Then the Modify Patient screen appears in this condition if you enter a new value to make desired changes in the patient s information and click the OK button the patient s information 1s revised Patient List Doctor Name Test atients 4 LL Mod ify Patient 3 791207 1111111 1 Oo o ho E LIW PatientlD Mask Consecutive Number PatientiD Name nes Birthday 2000 03 04 Age 9 4 Gender Female C Male Ethnicity Korean Height 160 0 Cm Weight 50 0 Kg gt Menopause No C Yes Take Pharmacy No C Yes Measurement Enter Ctrl Enter This list display only 200 patients If you wan 3 amp 2 If you want to delete the registered patients information select a desired patient using the mouse in the Patient List screen You can select several patients at the same time To do so click those patients while pressing th
11. al electronic devices and X ray devices They must be able to recognize hazards and protect themselves and others from injury The computer and the operator should be placed at least 2 0m from EXA 3000 being operated However the USB cable length should not be longer than 3 0m Never remove any system covers Especially the X ray generator which contains up to 80 Kvolts That can injure you If the fuses are gone exchange the same type 250V T315AL Otherwise a fire may occur or you may receive electric shock In case of changing the PC or the printer for other products check them according to IEC EN60601 1 1 Unplug the power cord before you move or clean the device and after using EXA 3000 For installation and operation of this equipment national regulation shall be considered Chapter 2 Configuration of EXA 3000 2 1 Composition of EXA 3000 2 1 1 Shape and Components of EXA 3000 2 1 2 Shape and Components of Measurement Equipment 2 1 3 Keyboard 2 1 4 Accessories List 2 1 5 Articles List 2 2 Installation of EXA 3000 2 3 Installation of Lifter 2 4 Before Turning on Power 2 1 Composition of EXA 3000 2 1 1 Shape and Components of EXA 3000 EXA 3000 Computer Power Switch Front View 2 1 2 Shape and Components of Measurement Equipment Heel Positioner EXA 3000 1 Heel Positioner When measuring calcaneus the heel positioner holds the foot 2 1 3 Keyboard Keyb
12. aneus Right Calcaneus Default Ethnic Default Menopause State k x Rev 4 No Yes Select Language English x IV Use Print Preview EE www osteosys com 4 Calibration Set the BMD value of the QC phantom Phantom BMD value should be the BMD values of QC phantoms which 1s included in the list of accessory The period of Daily test could be 3 days for the maximum Configuration itn settings Daily Test Hospital Doctor 010 0 Daily Test Parameter DATA Phantom BMD Value EES Interval of DailyTest S xl Day s Fill the Phantom BMD Value with a BMD Value on the phantom offered with a device en a This information is for the repot printing OsteoSys 3 2 3 2 Registration amp Deletion of Users 1 As soon as you configure the user environment the Select Doctor window appears as shown below If you are a registered user doctor click the Select Doctor button after selecting your name in the Select Doctor window using the mouse And then if you enter the password in the edit box Enter Password and click the OK button you can log in the program Select Doctor 1 Peter Jackson 82 2 2041 5600 2 OsteoSys 02 2041 5600 T The only one doctor use this program www osteosys com Select Doctor Enter Password Password p F T The only one doctor use this program better products for better life www osteosys
13. com 2 If you are a new user doctor click the New Doctor button in the Select Doctor window and then the New Doctor window appears If you enter your information name phone number department and password and click the OK button the registration process is completed The log in process 1s same as the description 1 4 EN L es b FR RN The Evolu Name Telephone Department Password Password Confirmation better products for better life www osteosys com 3 If you want to delete registered users select a desired user and click the Delete Doctor button of the Select Doctor window If there are two or more registered users the message box Move Patients inquiring your intention appears as shown below OK All registered users except the user you selected to delete are displayed on the left side of this OK button If you select the user who you want to move the patients data the user you selected to delete has measured until now to and click this button the data moves to the selected user s DB and the user you selected to delete 1s deleted NO If you click this button the user you want to delete and the patients data the user you selected to delete has measured until now are deleted Cancel If you click this button you can cancel the deletion process a Pee 7 66T Patients Shifting w 6166 From Doctor Osteo
14. dentifies the point where the system safety ground is fastened to the chassis Protective earth connected to conductive parts of Class II equipment for safety purpose Applied Part Type B The date of manufacture Radiation A symbol that shows this equipment makes radial rays l Table of Contents IEO S xri o cT e 9 1 1 General Product Information 9 Configuration of EXA 3000 eeeseeeessss 11 2 1 Composition of EXA 3000 cernere 12 2 1 1 Shape and Components of EXA 3000 12 2 1 2 Shape and Components of Measurement Equipment 13 PA SIN C T N Rec 14 21 4 ZXCCOSSOEIOS 6 eias roses eda oUe dra E conde ac M PEE NU EL LOCI 15 LAN E Suid M VIS T 15 2 2 Installation of EXA 3000 eee eee ee 16 2 9 Installation GE E aso Dite R 17 2 4 Before Turning on Power eee enne 20 Usine TN A SV ais niii eu e od T 21 S T Usine HM os ovi tatam ob End Eu EI d UD 22 SII Forearm ACQUISIQION iio od to AREE AE EE Cx ab aho cers 22 3 12 OS ales JA CqUISIUODL asin iei ES RREES AUN M ERE DE SEES XR ERR TER EXP EFIE 23 32 Usmo S W d ES 24 3 2 1 Progress Table of Program ss sss sss sss eee eee eee 24 3 2 2 How to install the Program 2 ss ss esec sss es esec sese aeaee eoo UO Dieser de 25 9 225 USING Program cess rcc catia t
15. e Ctrl key or if you want to select all patients within certain click the first and the last line of the area while pressing the Shift key 3 After selecting a desired patient click the Patient Deletion button on the bottom of the screen Then the message box Patient Deletion inquiring about whether to delete the information surely appears and if you click the OK button the information is deleted Doctor Name Test The number of patients 5 PatientID Name Gender Ethnicit Birth Year Regi Date 5 Peter Male Korean 1970 2009 11 09 4 Lee Young Hee Female Korean 2000 2009 03 04 3 Go Kil Dong Female Korean 1978 2008 05 22 791207 1111111 Hong Gil Dong Male Korean 1998 2008 02 28 1 Osteosys Male Korean 1979 2007 12 20 Patient Deletion Do you want to delete the current patient vje This list display only 200 patients If you want to find another patients Use Patient Search 3 2 3 5 Inquiry amp Deletion of Clinical History of Existing Patients 1 If you want to retrieve the clinical history select a desired patient and click the Patient s Info button on the right side of the Patient List screen Then Patient Info screen appears that contains the patient s clinical history 2 On the left amp below side the measurement results list shows If you select a measurement result in the list the relevant data 1mage BMD value date graph etc app
16. e default screen the message box Exit Program inquiring about whether to exit the program appears and if you click the Ok button the program is inactivated Exit Program Do you want to exit program s m Exit OsteoSys Chapter 4 Maintenance and Repair of EXA 3000 4 1 Resolution to Problems 4 20 Maintenance and Repair 4 23 Cleaning 4 2 2 Stockpile and Replacement of Articles 4 2 3 Storage 4 3 Safe Use of EXA 3000 4 3 1 Safety Rules 4 3 2 Cautions Related to Use of Electronic Medical Equipment 4 1 Resolution to Problems fp If EXA 3000 shows following symptoms check the system as follows Is the device properly plugged EXA 3000 is not activated with Isn t the power cord damaged the power on Aren t the fuses gone Is the devi ly pl d Computer is not activated with ve ceviee proper pusee HIC Power OM Isn t the power cord damaged l gt Wonltoris not activated wiih ae IBODSOPSNHERED ORE th f the computer on vpuns um epe User s instructions of monitor Screen of the monitor is not Adjust brightness bright enough User s instructions of monitor 3 2 2 6 Calibration of EXA 3000 system turns out to be abnormal Result of calibration of the Result of measurement turns E 3 2 2 2 BMD Measurement out to be abnormal 3 2 2 6 Calibration of EXA 3000 Is the desired part of the body properly Despite measurement placed according to the instruction
17. e device on the carrier Then fasten with the bolts removed from the base of the device as shown above For the safety you should fix the device in the lifter Otherwise the device can be dropped from the lifter when you adjust the height of the lifter or be inattentive 3 Fixing the USB Cable amp Power Cable There are three fixing holes in the body and the handle part for fixing the USB cable amp power cable After plugging each cable into the connector of the device arrange the cables and fix the cables using clamps and blots We recommend you to work according to the order 8 b C as shown above For the safety you should fix the USB cable amp power cable in the lift Otherwise the cables can be jammed in the lifter and they can cause some trouble when you adjust the height of the lifter or be inattentive 4 Adjusting the height of the Lifter If you want to adjust the height of the lifter pull the hand grip after holding the handle as shown above The stopper will be separated from the fixing hole Then adjust the height of the lifter with care and insert the stopper in the fixing hole CAUTION Be sure to fix the device in the lifter before adjusting the height of the lifter Otherwise the carrier can be bounced suddenly by the pressure of the gas spring in the lifter and you can be injured 2 4 Before Turning on Power 1 Connection of USB Cable Plug in
18. ea mente eee veanaewer tanks 27 3 2 3 0 USB Driver installation Vista W1mn7 sccccscccsssccesscceees 27 3 2 3 1 Execution of Program and Configuration of the Incipient Environment eee eee eene nnn 29 3 2 3 2 Registration amp Deletion of Users eee eee ees 31 323 3 BMD Medsurelie li eaten ette Ero Eod Does E eaa oed ads 35 3 2 3 4 Revision amp Deletion of Patients Information 40 3 2 3 5 Inquiry amp Deletion of Clinical History of Existing Patients 41 3 2 3 6 Calibration of EXA 3000 eee eee eee eee nennen nnn 44 35 2 5 7 Data Backup centu oan ed ouo RU E PUE IPA OU ue NO pSa ed vi EEIS 47 3 2 3 8 Configuration of Environment eee eee eene 50 3 2 3 0 Inactivation of EXA 3000 eee eee eere nennen 52 4 Maintenance and Repair of EXA 3000 53 4 1 Resolution to Problems eere eren 54 4 2 Maintenance and Repair eeeeeeeeee eene eene 55 2 OUS Be SC HUY LE OLEUM 55 4 2 2 Stockpile and Replacement of Articles 57 e ASSI mt TT 5 4 3 Safe Use of EXA 3000 iiit oe oua pie lose ho eH RENE URS Qn eb roceons 59 A31 Safety Rulis E 59 4 3 2 Cautions Related to Use of Electronic Medical Equipment
19. ears If you check the two check box Print Forearm amp Print Calcaneus next to the list you can select whether to print the results for each Patient s Name Go Kil Dong History History Result Image not for diagnosis pes Es Graph Original Image Colorized Image Measured Date BMD T Score UR 2009 11 09 0 526 094 L 2009 11 09 0 600 247 L EUM T Left Calcaneus 2008 05 22 0 552 1 37 L TScore T Ratio TScore T Ratio 0 51 107 25 96 LScore C Ratio LScore C Ratio 0 51 107 25 96 Calcaneus List Measured Date BMD T Score LR 2009 11 09 0 528 0 51 t 2009 11 09 0 475 0 25 L 2009 11 09 0 545 0 75 L Iv Print Forearm iv Print Calcaneus S OMe 3 In this condition you can measure BMD again Click the Measurement button on the right side for each You can execute them in the same way as described in 3 2 3 3 BMD Measurement lt Measurement of Patients gt 4 If you want to delete the clinical history of patients select a desired history and click the button Result Delete in the Patient List screen Then the message box Result Delete that inquiring about whether to delete the history or not appears If you click the OK button the history is deleted Result Deletion Do you want to delete the current result JJ rus Ie Print Forearm 5 After revising patients information scan site
20. ed it If you hear a strange noise or if you find any abnormality on the screen after turning on the product contact the headquarters or an agency Make sure to turn off the power switch before cleaning the product 4 3 2 Cautions Related to Use Electronic Medical Equipment Safety rules described below are based on Paragraphs 495 of laws and ordinances promulgated by Ministry of Welfare of Japan The safety rules pertain to use of electric medical equipment Read them carefully for safe use of the product and make sure to refer to 4 3 1 Safety rules 4 3 1 Safety Rules Nobody can handle EXA 3000 except for doctors and authorized personnel 2 Comply with followings in times of installation of EXA 3000 Do not install it in following places A Places where the product is exposed to water vapor B Places where the product 19 exposed to spray or splashing water C Places where the product 1s exposed to high density oil vapor D Places where the product is subject to excessive shocks or vibrations E Places where the angle of inclination of the mounting surface exceeds 10 degrees F Places where air pressure temperature or humidity drastically changes G Places exposed to direct sunlight or places where air 1s polluted due to dirt salt and sulfur H Places where chemicals are kept or toxic gas 1s leaked I Places where the AC power line voltage fluctuates heavily J Places where the AC power line volta
21. ement 5 Make sure patients do not move their foot while you make X rays lt Left Os Calcis gt lt Right Os Calcis gt S W 2 Using d 3 2 1 Progress Table of Program E HHO G 3 2 2 How to install the program 1 Enter the folder in Setup exe Mame KEY Driver Mask USB Driver SB Jata cab D datal hdr SB data cab ikernel ex layout bin Ti Sb RII set up inx 2 Click the Setup exe 3 The installation starts when the following image 1s shown file Size Type 224 KE 124 KE 30 951 KB 339 KE 1 KE 483 KB 55 KB 1 KE 138 KB File Folder File Folder File Falder ALZip CAB File InstallShield Media ALZip CAB File EX File ALZip BIN File gH BMP Te Application Configuration Settings InstallShield Compil EXA 3000 Date Modified 2010 01 19 S z 1 48 2010 01 19 2S 1 48 2010 01 19 E 1 47 2010 03 02 2A 9 21 2010 03 02 2A 9 21 2010 03 02 2A 9 21 2002 07 26 S 1 07 2010 03 02 2A 9 21 2010 01 19 S 2 00 2001 09 05 TA 4 23 2010 03 02 2 9 21 2010 01 19 S 1 57 Version 3 02 07 Copyright 2006 OsteoSys Co Ltd This Program is protected by international copyright laws 4 Click Next Button InstallShield Wizard Welcome to the InstallShield Wizard for EXA 3000_ 3 The install hield Wizard will install EXA 3000 72 on your computer To continue click N evt amp Back as 5 Click Next
22. equipped with air conditioning or heating Proper humidity AT Gu cn 20 809 d iie M f J E di Do not share the power outlet with other products through an extension cord Do not cover ventilation of the system or place it near the wall High inside temperature of the machine might cause a fire LL e d e Lr g aA b Do not install or keep EXA 3000 in a place where the machine can be rocked or shaken Make sure to place the sys tem parallel to the floor Install EXA 3000 in the place where it is free from water or chemicals Do not use the system near equipment that generates strong magnetic fields 100 240V is usable When EXA 3000 is taken out of a warehouse insulating transformers should be set to 100 240V Since sudden power outage can remove all data saved in the product you should install EXA ms ay 3000 in the place 9 ee 1 where a power lewd supply is stabilized nni 2 3 Installation of Lifter 1 Shape and Components of Lifter Handle Part Below picture Body Carrier Fixing Hole Lifting Handle Base Hand Grip 2 Fixing the device There are four fixing holes in the carrier for fixing the device On the other hand there are four holes in the base of the device and they are fastened with each bolt To fix the device in the lifter remove the blots from the base of the device using a tool and match each hole after placing th
23. ete BMD 0 600 T Score 2 17 Image Mode Original Image C Colonzed Image 4 If you click the OK button the results of X ray appears in the screen as shown below on the contrary if you click the Remeasure button you can restart to measure BMD Patient s Name Go Kil Dong Measure Image Mode Original Image C Colorized Image CAUTION When you hear the alarm sound you should let a patient put his arm or foot out of the device Even if there is no sound caused by some trouble in the system after clicking the Start Measure button you should let a patient put his arm or foot about 5 seconds after 5 If you click the Print Preview button on the bottom of the screen that shows the results after measuring BMD you can see the results that will be printed out in advance as shown below If you click the Print button on the top of this screen the results is printed out The Print Preview function can be set in the Configuration menu 3 2 3 8 Configuration of Environment Pie cese Report Printed Date 2009 11 09 Patient s Info PatientlD Name Birthday 1978 12 22 30 9 Gender Female Helge ro 170 0 Cm Woighp roe 57 0Kg Menopause 20 40 60 80 100 Age Measured Date 2009 11 09 10 41 EMD 0 526 g Cm2 DNC 1 048 g 1 99 Cm2 LOO 0 94 Young Adult T Ratio 112 0
24. f you want to configure the user environment again click the Configuration button in the default screen There are four items from Settings to Doctor in this menu 2 Settings 3 3 2 1 Execution of Program and Configuration of the Incipient Environment ID Mask and Language Hospital Information Se Doctor s Information S better products for better life www osteosys com 3 Calibration a 3 2 3 1 Execution of Program and Configuration of the Incipient Environment Interval 5 Day Fil the Phantom BMD Value with a BMD Value on the phantom offered with a device WwwWw osfeosys com 4 Hospital 3 2 3 1 Execution of Program and Configuration of the Incipient Environment This information is for the report printing um better products for better life www osteosys com 5 Doctor You can set your name phone number and department If you click the Change PW button you can change your password 111 1 mE 3000 Basic Infomation Current Password New Paseword New Password Confirmation AY Kf you want to change password click Change PW button Aker edting password click Change PW button for the purpose of saving NEN The only one doctor use this program Accept Cancel ln Exit Program OsteoSys 3 2 3 0 Inactivation of EXA 3000 If you click the Exit button in th
25. ge fluctuates heavily while this product is operating K Places where there is a ventilation problem L Do not lean shake or rock the product during transportation M Adjust frequency voltage or current to the product N The product is portable but make sure to put a brake on it when you stop the product O Ground the product by using ground wire P Do not share the power outlet 3 Check followings before using the product A Whether power is off before putting a plug in the socket B Whether the power supply line is suitable with that of the system AC 100 240 V C Whether the system 1s fully grounded D Whether all the connection parts power and optional equipment are connected with the system properly 2 4 Before Turning on Power E The product has been factory set for optimum performance Do not attempt to adjust any preset controls or switches except for operation as specified in this manual F If you experience any trouble with the product turn it off immediately and contact OsteoSys or its authorized dealer for assistance G Before electrically or mechanically connection any other manufactures devices Ne to EXA 3000 contact OsteoSys or its authorized dealer for instructions H Do not operate the product improperly when you use it with other products I Make sure to check whether external parts of the device directly touch the patient J Make sure to check whether the products keep distances at
26. hould be placed 50cm or more away from a table or floor 2 Set EXA 3000 for the forearm acquisition mode 3 There is the base line on the heel positioner as shown below Put a wrist part on the base line and place it as close to the right side detector as possible in order to keep the absorbed dose to patients low as shown below lt Forearm default positon gt 4 In times of making X rays pull up sleeves and take off accessories such as wrist watches or bracelets Make sure not to place any things besides the forearm in the slot it may arise some adverse effect during the measurement 5 Make sure patients do not move their wrist while you make X rays X E a k L N het K x lt Left Forearm gt lt Right Forearm gt 3 1 2 Os Calcis Acquisition 1 Adjust the height of the lifter for measuring patients Os Calcis 2 Set EXA 3000 for the Os calcis acquisition mode as shown below lt Moving the heel positioned for heel measurement gt 3 Place a foot as close to the right side detector as possible in order to keep the absorbed dose to the patient low as shown below 4 Let patients take off their shoes before making X rays Patients do not have to take off their socks or stockings but if they are wearing thick socks or something that includes metal make sure they take them off Make sure not to place any things besides the foot in the slot 1t may arise some adverse effect during the measur
27. in operation A Whether the product and the patient are normal B Whether the products keep distances with one another C If you find any abnormality related to the product or patient stop its operation and check if it can cause any danger to the patient D EXA 3000 uses X ray If there are any other substances socks or clothes between diseased part and X ray source or detector the device cannot take accurate measurement Accordingly take measurement when there are no foreign substances on the diseased part E If the fuses are gone exchange the same type 250V T315AL Otherwise a fire may occur or you may receive electric shock NOTE Fuse Replacement Close FREDA _Fuse Holder iP 6 3 1 Open the fuse drawer on the upper side of the appliance inlet there will be the two small fuse holders 2 Push the fuse holder toward the arrow direction and Pull the fuse holder toward the upper side of the appliance inlet 3 Remove the old fuse by pulling up 4 Install the new fuse by pushing to the fuse holder 5 Insert the fuse holder to the appliance inlet At this time the arrow direction in the upper side of the fuse holder should be in accordance with that on the fuse draw 6 Also the same method is used to exchange the other fuse folder Close the fuse the drawer CAUTION For continuous protection against a risk of fire hazard replace only with same type and same rating of fuse
28. l not be responsible to you for incidental or consequential damages of any kind arising from or connected with the use of its equipment
29. least 10cm from walls CAUTION Equipotential Bonding In hospital doctors and patients are subjected to dangerous uncontrollable compensating currents These currents are due to the potential differences between connected equipment and touchable conducting parts as found in medical rooms The safest solution to the problem is accomplished is consistent equipotential bonding Medical equipment is connected with connecting leads made up with angle sockets to the equipotential bonding network in medical rooms Equipotential Connection Lead Terminal Socket k nd Main Body Equipotential P Connector tb Earth in Medical Room Try to place the system far from power generators X ray machines broadcasting stations and transmission lines to avoid electrical noise during scanning Otherwise abnormal images may result An independent circuit and safely grounded outlets are strongly recommended for EXA 3000 Poor or abnormal images may occur if the system shares a power source with other electrical or electronic equipment The classification according to standard IEC EN 60601 I Type of protection against electric shock Class I Degree of protection against electric shock Type B Degree of protection against harmful ingress of water IPX 0 Methods of sterilization or disinfection See Chapter 4 2 1 Not suitable for use in the pressure of flammable anesthetic mixtures Check followings while the device is
30. lick the OK button results of calibration are appeared Daily Test Success 2009 11 09 Daily Test Succeed S N 0000000 BMD 0 Whenever you execute Daily Test or Calibration you should use the QC Phantom included in the accessories list And you should set the BMD value of the QC Phantom on the Configuration menu 3 2 3 8 Configuration of Environment 3 2 3 7 Data Backup If you need to save the data click the Backup button in the default screen If you click the button the default screen of Backup menu appears as shown below Backup Database shall be saved for backup Database shall be retrieved Database shall be cleared Database shall be recovered Database File Handling U PR better products for better life www osteosys com 1 Backup If you click this button you can save all users DB in the PC Backup Database shall be saved for backup Save As B gt File name E3K Whole Backup 091109 105651 wdb Save 8 Save as type Whole DB wd Cancel 77 It can be affects other doctor s database Only be used by administrator 2 Retrieve If you click this button you can exchange all users DB into others in the PC Backup g Database shall be saved for backup Database shall be retrieved Oper Look in C3 Backup t c Eg auto Daily E3K Whole Backup 081118 15363
31. n is 1 1 1001 22233 the name of file is Osteosys E3k 1 1 1001 22233 release exe 5 Click Next Osteosys Exa3k Driver V1 0 810 23315 amp InstallWizard 2i LIEF eu x a a e a 3 A f ce j aa L 6 Click Install OA 2 2 285 SAS ASU DIXI DUS APES SAS MEE SISLILE Al Sora SAS SSAA SS ASSL MASS OAS SSAAS OAS ZSS BASS alas t a Omm axl S aZ a tannet 7 Completed installation USB Driver 3 2 3 1 Execution of Program and Configuration of the Incipient Environment 1 Press the power switch 2 10 seconds after calibration that checks functions of the system and memory device the program is automatically activated and you should configure the incipient environment 3 Settings Patient ID Mask Set the type of patients ID Default Measure Site Set the default measurement part of the body Default Gender Set the default patient s gender Default Ethnic Set the default patient s race Default Menopause State Set the default patient s menopause state Select Language Select your own language to use the program Use Print Preview Select the function Print Preview or not PatientID Mask f Consecutive Numbers p Jess999 9999999 amp alphabet 9 number both COTARAAAAAA AAAAAAAA v Default Measure Site Default Gender f LeftFoream Right Forearm gu o C LeftCalc
32. n of registered patients This list display only 200 patients If you want to find another patients Use Patient Search 12 3 B E 2 If you want to register new patients click the New Patient button on the bottom of the Patient List screen Then the New patient window you can enter the information of new patients appears Enter the information and click the OK button Then the patient is registered and the information is displayed Doctor Name Test New Patient 3 791207 1111111 1 Z A PatientID Mask Consecutive Number i SEE PatientlD p Name E Birthday 2009 09 15 Gender Female C Male Height cm gt Weight fkg gt Menopause No C Yes Take Pharmacy No C Yes Enter Ctrl Enter This list display only 200 patients If you wan 3 If you want to retrieve registered patients click the Patient Search button and then the Search Patient window contains the retrieval items name ID gender and date of measurement appears If you enter the desired patients information and click the OK button then the results appears in the screen 3 ale o 791207 1111111 Test Female Korean 1998 2008 02 28 1 Test Male Knrean 1979 2007 12 20 Search Patient Name v PatientlD r Gender Female C Male Birth Year T Ex 1976 This list display o
33. nly 200 patients If you want to find another patients Use Patient Search lt Measurement of Patients gt 1 If you want to measure BMD select a desired patient using the mouse in the Patient List screen and click the Measurement button on the right side of the screen Then the Measurement screen appears as shown below Device Information High Low No Image Energy Energy Voltage kv 80 5 CurrentimA 0 25 Second s 1 5 1 0 2 5 2 Click the Measure Start button on the bottom of the Measurement screen Then the message box Measure Start inquiring measuring parts of the body appears If you select measuring parts and click the Measure Start button X ray radiates from the X ray source Oneca ELI Left Forearm Right Forearm C Left Calcaneus C Right Calcaneus PR oA Original Image eon on M 4 20 40 60 80 100 3 When X ray radiates the word on the Measure Start button is changed into Measure Stop In case of emergency click this button Then X ray radiation stops In the normal condition the message box Measurement Complete inquiring about whether to restart to measure BMD or not appears with an alarm sound after BMD Measurement being finished Measure Site gt Measurement Compl
34. oard Activate EXA 3000 by pressing a key on the keyboard according to the instructions shown on the monitor The manual shows keys required to activate EXA 3000 as shown below Enter key Je ELI dr T ar Space key 2 1 4 Accessories List Accessories marked is articles of consumption 4 2 2 Stockpiles and Replacement of Articles E QC Phantom E Daily Phantom E It is used to calibrate the system a a Make sure to keep it at a designated place so that users can read it anytime they need to It is used to connect to the source of electric power with the main body of EXA 3000 Power Cable It is used to connect to the computer with the en apie main body of EXA 3000 It is used to install the program on the Program CD l computer The program is installed on the computer before being delivered 2 1 4 Articles List 4 2 2 Stockpiles and Replacement of Articles Names of product Specifications A Manufacturer HP 3820 Ink Cartridge Manufacturer HP 3820 2 2 Installation of EXA 3000 Since EXA 3000 is made up of precise components you should install the product according to instructions below Do not install and keep EXA 3000 at excessively high or low temperatures Proper temperature 18 27 C Do not install the system in a place with polluted air and high humidity and do not expose the machine to direct ray sunlight It is advisable to use EX A 3000 in a place
35. own on E A 3000 a Q O jr D N O X ray On A Symbol that shows the location of the X ray On light It is also shown on the screen during quality control and patient measurements when EXA 3000 is making X rays X ray Source A symbol shown on the screen during quality control and patient measurements when EXA 3000 is not making X rays Shutter Open A symbol that shows the location of the Shutter Open light It is also shown on the screen during quality control and patient measurements when the shutter is not fully closed Shutter Closed A symbol shown on the screen during quality control and patient measurements when the shutter is closed Power On A symbol that shows the location of the Power On light Start Appears on a button 1f EXA 3000 will make X ray when you select the button Communication Failure A symbol that appears on screen in place of the X ray On symbol during a measurement if the computer loses contact with EXA 3000 Make sure the X ray On light on EXA 3000 is off if this symbol appears If the light is not off turn off EXA 3000 I and O on power switch represent ON and OFF respectively gt The Attention symbol that marks warning and important information in the user s manual The conductor provides a connection between equipment and the potential equalization bus bar of the electrical installation Indicates dangerous voltage over 1000VAC or over 1500 VDC I
36. s its result turns out to be abnormal 3 2 2 6 Calibration of EXA 3000 CAUTION If you cannot resolve the problem contact to OsteoSys or its authorized dealer Hasn t the system been calibrated for long 4 2 Maintenance and Repair 4 2 1 Cleaning CAUTION Turn off the power before cleaning the product Dust the monitor with a soft brush every day Clean the screen of the monitor with a soft cloth If there 1s a strong stain on the cover soak a clean and soft cloth with neutral detergent diluted with water in about a ratio of 5 to 1 and dry the cloth and remove the stain with it And then wipe out the Monitor stained area with soft and dry cloth again Make sure not to put water or detergent on the monitor directly Water or detergent can damage C MOS rp the monitor If you use volatile chemicals such as benzene or thinner surface of the monitor can be damaged Dust the computer with a soft brush everyday If there 1s too much dirt on the computer soak a clean and soft cloth with neutral detergent diluted with water in about a ratio of 5 to 1 and wring water from the cloth and lt S dk wipe out dust Computer i Pal si sure not to put water or 3 detergent on the computer E cot directly Water or detergent can i damage the computer Make sure not to use volatile chemicals e such as benzene or thinner s d Re because it can damage the E p surface of main body of the
37. sion Accuracy Imaging Imaging Area 100mm x 100mm Exposure Time Accuracy l 5sec High 1 0sec Low Angle of Reference Axis 3 Minimum Quality Equivalent Filtration 2 5mm Al Environmental Not to exceed 2G 1n six millisecond Install system in a clean well ventilated area Excessive dust and other airborne debris Dust Fumes Airborne debris contaminants can impair sensitive parts We recommend instituting a No Smoking policy in system area X ray Source l ube Housing 3F 308 Byuksan DigitalValley 3 212 13 Guro Dong Guro Gu Seoul Korea Tel 82 2 2025 1650 Fax 82 2 2025 2299 Nominal Tube Voltage 80 kV High 55 kV Low Manufacturer Address Input Voltage 24V DC 15V DC Inherent Filter 3 0 mm Al O Added Filter Filtration 80 kV Filter Wheel 0 8mm Brass Zn 3096 Cu 7096 55 kV 1 6mm Polycarbonate X ray window 2 5 mm AI Loading Factors for Maximum Energy Input at Nominal kV eee ones Maximum Continuous Heat Dissipation aW 0 25 W Maximum X ray Tube Assembly Heat 183 000 J Content Distance 180mm Maxi S trical Radiat Field Maximum Symes Radiation Field Field size 50mm x 50mm O Angle 5degree with respect to the image receptor O Location from the focal spot to the center of the image receptor Reference Axis Focal Spot to Image Receptor Distance X ray Tube 1220 Claussen Drive Woodstock IL 60098 Tel 815 338 4424
38. sys w To Doctor Test x Not shitt No Delete all about Doctor Osteasys NO Not shit Not delete gt lt Cancel Return to Select Doctor OsteoSys 4 If you click the OK or NO button the message box Really Delete Doctor inquiring whether to delete the user surely appears If you click the OK button the user information is deleted And if you click the Cancel button you could cancel the deletion Patients Shifting oD U 9 B Surely Delete Doctor Vv 09 Not shit Not delete 3 Return to Select Doctor Cancel Selected doctor s data shall be shifted Exit Program Octane 5 If there is only one registered user when you click the Delete Doctor button in the Select Doctor windows the message box Last Doctor inquiring to advise data backup and to delete the user surely appears If you click the OK button the deletion process starts Select Doctor The Last Doctor Backup is needed Anyway delete 6 If you are only one user check the checkbox The only one doctor use this program on the bottom of the Select Doctor window Then you can use the system without entering password 3 2 3 3 BMD Measurement lt Registration amp Retrieval of Patients gt 1 If you click the BMD Measurement button in the default screen you can move to the Patient List screen contains all informatio
39. the USB cable Plug into the connector When you detach the USB cable from the main body of EXA 3000 do not hold the cable and instead hold the connector Otherwise wire could be down 2 Connection of Power Cable Make sure that the covering of cable is not damaged to prevent electric shock or short circuit If you find any damage or any sign of it immediately contact an agency Put the Power cord into only one plug Make sure not to share the power outlet Avoid sharing the outlet to prevent EXA 3000 from being affected 3 Make sure that paper is properly provided to the printer Supply of paper 4 2 2 Stockpile and Replacement of Articles Chapter 3 Using EXA 3000 3 1 Using H W 3 1 1 Forearm Acquisition 3 1 2 Os Calcis Acquisition 3 20 Using S W 3 2 1 Progress Table of Program 3 2 2 How to install the program 3 2 3 Using Program 3 2 3 0 Installation of USB Driver 3 2 3 1 Execution of Program and Configuration of the Incipient Environment 3 2 3 2 Registration amp Deletion of Users 3 2 3 5 BMD Measurement 3 2 3 4 Revision amp Deletion of Patient s Information 3 2 3 5 Inquiry amp Deletion Clinical History of Existing Patients 3 2 3 6 Calibration of EXA 3000 3 2 3 7 Data Backup 3 2 3 8 Configuration of Environment 3 2 3 0 Inactivation of EXA 3000 3 1 Using H W 3 1 1 Forearm Acquisition 1 Adjust the height of the lifter for measuring a patient s forearm The device s
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