SONOST 3000
Contents
1. lt Patch gt Software upgrade LI Settings It makes fundamental settings related Software System Cleaning Backup Patch Settings Enter Hospital Name Lage i OED Qr Setup gt Settings Window OT00 2F0423 01 2 1 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Hospital Name Insert the hospital name which will be on the report Default Scan Site Select the default scan site when measure Default Gender Choose the gender when insert the patient s information Default Ethnicity Choose the ethnicity when insert the patient s information DailyTest Interval Fix the interval of daily test Default Printer Choose the internal thermal printer or external general printer External general printer will be supported later on Ink Economic Mode Choose the Ink Economic mode when use the external printer Setup printer Q System It makes settings related Operating System Settings Cleaning Backup Patch 3 21 2008 5 44 54 PM i Setup gt System Window System Date Time Present time setting It becomes standard for patient s registered date measured date and printed date Fix the time and click the lt Save gt button Touch Panel calibration It is used when the touch panel is out of order Read the screen message carefully then press the arrow indicated point2. O Ground the product by using ground wire P Do not share the power outlet OT00 2F0423 01 4 2 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 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 is fully grounded D Whether all the connection parts power and optional equipment are connected with the system properly 2 3 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 to SONOST 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 touches the patient J Make sure to check whether the products keep distances at least 20cm from walls A F VN CAUTION Equipotential Bonding In hospital doctors and patients are subjected to dangerous uncontrollable compensating cur
3. exactly OT00 2F0423 01 22 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Q Cleaning It makes probe is moved of user s own accord for cleaning Settings System Backup Setup gt Cleaning Window Narrow It makes narrow the probe s interval Stop It makes the probe stop Widen It widen the space of two probes LJ Backup It controls the measured data Settings System Cleaning Backup Patch Setup gt Backup Window Export If you click this button you can export data to USB memory stick or external printer OT00 2F0423 01 2 3 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 8 13 04 gt 32 19 AME 8 13 04 3 13 28 AME 1941 lB984595 amp KIM JS GED Qr All Export all data By period Export data within a selected period of time Setup gt Backup gt Export Window Individual Export selected patient s data Destination You can select USB Memory Stick or Printer But If you are select Individual you can t select printer Clear If you click this button you can clear data 8 12 04 11 50 02 PM Al 8 13 04 4 32 03 AM OD QD Setup gt Backup gt Clear Window All Clear all data By period Clear data within a selected period of time I
4. High inside is taken out of a warehouse insulating temperature of the machine might causea transformers should be set to 100 240V fire Since sudden power outage can remove all data saved in the product you should install SONOST3000 in the place where a power supply is stabilized OT00 2F0423 01 1 2 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 2 3 Before Turning on Power Connection of Power Cable with the outlet 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 Avoid sharing the outlet agency Put the Power cord into only one plug Make sure not to share the power outlet to prevent SONOST 3000 from being affected OT00 2F0423 01 13 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Chapter 3 Using SONOST 3000 3 1 Using H W 3 1 1 Patient Measurement Procedure Clean the surface of the Coupling Pad with an alcohol and apply gel enough Clean the both side of patient s heel with an alcohol pad and apply gel Insert patient s foot Let a patient move his foot up to down just like this picture Start to measure after insertion OT00 2F0423 01 14 A4 210 x 297 User s Manual Confidential Os
5. 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 4 Cosmetic defects or deterioration will not be refinished or replaced The costs of replacement of fuses are not covered 5 OsteoSys Co Ltd will not be responsible for any loss damage or injury resulting from delay in rendering service under this warranty 6 OsteoSys Co Ltd will not be responsible to you for incidental or consequential damages of any kind arising from or connected with the use of its equipment OT00 2F0423 01 5 3 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL What Should be Noted in Times of Request of Repair 1 If the product is out of order stop using it and read the manual carefully 2 Before you request for repair switch off the product and contact a designated service agency after checking the name of model serial number and date of purchase OsteoSys Co Ltd will replace the defective product at no cost to you OsteoSys Co Ltd will pay the shipping and insurance costs of product sent to you 3 Defective equipment shipped from you to OsteoSys Co Ltd must b
6. SONOST 3000 DOC No OT06 2R0422 00 MUL about 15 seconds after then the Measure Complete window is appeared with the alarm sound If you click the lt Ok gt button the detailed results is displayed as shown below a x i lt Home a Patient History Measure ID 99 Name 00 Date 2008 03 21 Time 17 56 Site Left Foot SOS 1532 6 BUA 41 6 BQI T score Z score Detailed results screen If you click the lt Print gt button on the bottom of results screen then the Enter Hospital Naar Patient Infg sse0erseess ID Hase a Year of Birth 2004 Female Ethnicity Koreen Regi Date 2000 01 06 Foot Supporter Heesured Times History seeememeenssessesese Left Foot Ho Date Bol T 5oor 3 2000 01 06 8 4 0 4 2 2000 01 06 88 7 0 8 1 2000 01 06 8 1 Printed Report OT00 2F0423 01 3 0 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 2 5 Revision and Deletion of Patient s Information LJ Revision of Patient s Information If you want to revise the registered patients information select a desired patient and click the lt Modify gt button on the bottom Then the Modify Patient screen appears as shown below in this condition if you enter a new value to make desired changes in the patient s information and click the lt OK gt button the patient
7. call the OsteoSys Co Ltd customer service department or your OsteoSys Co Ltd distributor OT00 2F0423 01 49 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Chapter 6 Reference 6 1 Definition of Parameter Terminology BUA Broadband Ultrasound Attenuation Parameter which reflect bone density and structure by reduction analysis of ultrasound pulse intensity which through the bone SOS Speed Of Sound Velocity of ultrasound wave through the bone which reflect bone mineral density BQI Bone Quality Index Generally SOS is in proportion to the temperature and BUA is in inverse proportion to the temperature These correlation coefficients are a B combined for as shown below This Parameter which is represented constant number compensates the precision error from the temperature The relation between age and BQI Refer to the picture BQI a x SOS B x BUA T Score Average BQI in twenties Young adult that is BQI standard deviation in twenties 1 More han 1 Normal 2 1 2 5 Osteopenia 3 2 5 and below Osteoporosis T Score s meaning in the view of probability T Score represents the patient s BQI above or below a reference Young adult mean and is expressed in standard deviation SD units Therefore E patient s BMD value makes normal distribution shape then T Score means in the view
8. 37 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Chapter 4 Maintenance and Repair of SONOST 3000 4 1 Resolution to Problems 2 If SONOST 3000 shows following symptoms check the system as follows SONOST 3000 is not activated Is the device properly plugged with the power on Isn t the power cord damaged Result of calibration of the i system turns out to be 3 2 6 Calibration of SONOST3000 abnormal Result of measurement turns 3 2 4 BMD Measurement out to be abnormal x 3 2 7 Calibration of SONOST3000 Is the desired part of the body properly Despite measurement according placed to the instructions its result o 4 2 1 Cleaning Disinfection turns out to be abnormal LE Daai Sterilization A Aw CAUTION If you cannot resolve the problem contact to OsteoSys or its authorized dealer OT00 2F0423 01 3 8 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 4 2 Maintenance and Repair 4 2 1 Cleaning Disinfection Sterilization A a G f CAUTION Turn off the power before cleaning the device After using the device wash with water The device should be cleaned with a water wringed clean soft cloth everyday because gel remains around the probe or below the device Especially gel stained on the probe should be removed Af
9. 43 Sale Usec oi SONOS TD S000 ssvescssesssseavtvireansavisssdenscossusuckeaseuteieceasavieasinatssnseeneses 41 ASSN Salet y RUES ieie aen nEn NE ENE NEEE EEEN 41 4 3 2 Cautions Related to Use Electronic Medical Equipment 42 Chapter 5 Specifications amp Software Updates sscrsssssscssssssccsscccccccsssssees 47 OT00 2F0423 01 5 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 5 L SPECICATION ssanie eaaa aai 47 S2 SOW ALE Updates ossea sieua aa orae aaora 49 Chapter 0 Referenc caia E 50 6 1 Definition of Parameter Terminology ssssseccccocssssscececocossssceccecosssssseeeesssssos 50 0 2 Reference Data cosins aE ANE EA EESOSA 52 Chapter 7s Product Warranty cccccssiccssceorsccacscciscscvetsccucsseiacscveieccssseesacsceesesdssesssesacvotans 53 OT00 2F0423 01 6 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Chapter 1 Introduction Osteoporosis is one of the serious diseases This device is a bone densitometer which estimates a bone mineral density of the calcaneus by ultrasound The measurement site is the calcaneus It takes about 1 minute to measure the density and to display the shape of ultrasonic wave by computing simulation on the monitor To ensure safe operation and long term performance stability it is essential that
10. you fully understand the functions operating and maintenance instructions reading this manual before operating the equipment OT00 2F0423 01 7 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL X Features and Cautions This device is an ultrasound bone densitometer which has 0 2 T score precision error The equipment must be operated only by or under supervision of a qualified person When you give the appropriate commands in SONOST 3000 software ultrasonic waves are generated The generated ultrasonic waves pass through the Patient s calcaneus and the electric signal is treated by SONOST 3000 algorithm All operators must understand the potential hazards in the use of medical electronic devices They must be able to recognize hazards and protect themselves and others from injury The system should be placed at least 20cm from the wall Never remove any system covers In case of changing the printer for other products check them according to IEC EN60601 1 1 Unplug the power cord after using OT00 2F0423 01 8 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Chapter 2 Configuration of Device 2 1 Composition of Device 2 1 1 Shape and Components of Device Connection for the power cord and power SWITCH PANEL ON OFF switch EXTER
11. Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 4 3 Safe Use of SONOST 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 4 3 2 Cautions Related to Use of Electronic Medical Equipment 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 is damaged or broken CAUTION 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 need it If you hear a strange noise or if you find any abnormality on the LCD screen after turning on the product contact the headquarters or an agency Make sure to turn off the power switch before cleaning the product OT00 2F0423 01 At A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 4 3 2 Cautions Related to Use Electronic Medical Equipment Safety rules described below
12. NAL USB Port for printer keyboard and mouse CONNECTOR OT00 2F0423 01 9 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Use Accessory which defined at user s manual 2 1 2 Accessories List gy Check the following accessories before installing the system z If they are not in good condition contact to OsteoSys or its authorized dealer for this service Make sure to keep it at a designated place so that User s Manual users can read it anytime they need to Foot Positioner Use them in accordance with patients foot size It is used to calibration the system QC Phantom poo Keep it in the specified place and N protect it against deformation by heat k or pressure It is used to connect to the source of electric power with the main body of SONOST 3000 Power Cable 30 Ta Make sure to connect it with a A grounded electric outlet OT00 2F0423 01 10 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 2 1 3 Articles List 2 Check the following accessories before installing the system e If they are not in good condition contact to OsteoSys or its authorized dealer for this service E 4 2 2 Stockpiles and Replacement of Articles It helps ultrasound to progress between a Ultrasound Gel 2 bottles probe and patient s heel It removes some ma
13. SONOST 3000 User s Manual Model SONOST 3000 Council Directive 93 42 EEC Concerning Medical Device Osteosys http www osteosys com OsteoSys Co Ltd 308HO byuks san Dig ital Valley 3rd B D 212 13 Gur a Guro ku Seoul Korea OsteoSys CO LIARS President Young Bok oia k j 7 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL SONOST 3000 User s Manual Software Version 3 03 06 Document Version 4 00 Document Number OT06 2R0422 00 MUL Manufacturer and EC Authorized Representative Information Manufacturer OsteoSys Co Ltd 3F 308 Byucksan Digital Valley3 212 13 Guro Dong Guro Gu 152 848 Seoul Korea Tel 82 2 2025 1650 Fax 82 2 2025 2299 EC Authorized Representative Ecornet Medical GmbH High t Part Mainstr 6c d D 45768 Marl Germany Tel 49 2365 92 437 0 Fax 49 2365 92 437 55 A T L CAUTION 1 You must be well acquainted with this manual before using it 2 This manual should be placed where the user could read it whenever necessary OT00 2F0423 01 2 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Thank you for purchasing SONOST 3000 Ultrasound Bone Densitometer To ensure safe operation and long term performance stability it is essential that you fully understand the functions and operating maintena
14. al history and Result SONOST 3000 support inner printer thermal printer and external printer normal USB printer If the selected model is exclusive use of external printer Inner printer will not be provided LJ Inner Printer Thermal Printer Inner printer is affixed on the device back inside It will be able to use without software setting Enter Hospital Nase Patient Info Normal Scan Date 2000 1 6 Scen Tise 16 10 Site Aight Foot 80 89 4 T score 0 8 65 9 Z score 0 8 85 9 SOS 1584 1 BUA 61 4 Printed result paper LJ External Printer Normal Printer SONOST 3000 use a general USB support printer as external printer It is required to setup printer in detail because a kind of external printer various OT00 2F0423 01 36 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Printer Hewlett Packard Desk Print Range Orientation ae PTL sl Portrait Selection Landscape Met Path O O aia ae e Ag 1 Advanced v I color Right 1 Bottom 1 Paper Size Printer Selection of printer Port Selection of port Must select LPT1 Paper Size Selection of paper size Draft Mode Selection of print quality Checked Low Quality No checked High Quality Color Selection of color or gray SONOST 3000 OsteoSys SONOST 3000 Printed result paper OT00 2F0423 01
15. 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 a 4 3 1 Safety Rules 1 Nobody can handle SONOST 3000 except for doctors and authorized personnel 2 Comply with followings in times of installation of SONOST 3000 Do not install it in following places A Places where the product is exposed to water vapor B Places where the product is exposed to spray or splashing water C Places where the product is 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 is polluted due to dirt salt and sulfur H Places where chemicals are kept or toxic gas is leaked I Places where the AC power line voltage fluctuates heavily J Places where the AC power line voltage 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
16. as shown below Outer surface of paper should face to the inside of the device Paper is scrolled in automatically OT00 2F0423 01 17 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 Cover shutting Put the paper to the gap in the cover then shut the cover up Paper cutting For a sharp outline of report printing cut off the remained paper once by a saw tooth in the cover CAUTION Do not touch the metal part of the thermal printer head The hot surface may cause to burn A4 210 x 297 OT00 2F0423 01 18 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 2 Using S W 3 2 1 Progress Table of Program Dailytest Setup Home Product Information Add Patient ute Patient List as rea 7 vt Start Measure Print Result Print History Delete History OT00 2F0423 01 19 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 2 2 Execution of Program N CAUTION If you hear any strange noise from the screen switch it off and contact to OsteoSys or its Authorized dealer LJ Turn on the power switch 10 seconds after calibration that checks functions of the system and memory device the program is automati
17. button in the Home screen Then the DailyTest screen appears as shown below When you click the lt StartDailyTest gt button DailyTest is started If the DailyTest success the message box Complete Dailytest appears and back to Home screen If you select the Time tap graph appears in the time domain If you select the Frequency tap graph appears in the frequency domain eqeccccccnunnnasaanccccccccepenananaapeccccccep eee ssasqasccccccqocseensnnunasccconcccssssenpuauscccopocecessepunnasace H H wee cence bec c ewww nd annn nace decccccnn tan nn nana dacccccccath ann nnneabenccccccbannnnnnndanccccccdecnssnnadnansence ds cccnsessthanasccseteccccccebennnases Tea aiir riai aai aioa OE Grid A mite Rew SE elope iaeia Ui ceed Bete ee a WA omc ig OG aeRO al TW Aa aan aS Seen Sees Petree Peet eee eee eee eee Peery Pee eet Pree eee eee eee eee eee Jaaa a eaa ra ate Nm AR gh i ca a a el Be i GTO la wt te A De y AEE SAR TA AER S EIEE ET L LOA a cn Bele c E OE mead AEE Sa aud A VI EI EANA N KIE PA A E EENE NA ASSA ed E EE E Peers TETT eter iret Peete eee eee ree eee Sete ered Peer ee eee erie Peer e re errr ree eee eee feet r ie Seer ee eet Serer rey NNE NENAS OETA OEE ee ON Ay ee eT PRR ee et Ea OAT NURS Cot cok Saad te WN ee LS pee EET ERs ON Ling Oe y Peery Peet eer rrr rere errr er rere rr Seer ert Serer rer Peer err t reer rrr t Pere er err reer rrr errr rr reer rr Peer errr Serre rry wee een nn
18. button on the History List screen the detailed result of the selected patient appears in the full screen r F 7 lt lt Home P Patient E History Measure ID 99 Name 00 Date 2008 03 21 Time 17 58 Site Left Foot SOS 1531 5 BUA 40 5 BQI T score Z score Detailed Result Screen OT00 2F0423 01 3 2 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL LJ Deletion of Clinical History of Existing Patients If you want to delete the clinical result of patients select a desired result and click the lt Delete gt button on the bottom of the result screen Then the message box Delete History that inquiring about whether to delete the result or not appears If you click the lt OK gt button the result is deleted Home f Patient E History la Measure ID 99 Name 00 Delete Patient Window OT00 2F0423 01 3 3 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 2 7 Calibration of SONOST 3000 Daily Test Q DailyTest Make sure to calibrate the system to reduce a margin of error and to get accurate value in times of examining bone density It is to raise credibility of examination results through checking of system reliability on a daily basis To calibrate the system click the lt DailyTest gt
19. cally activated and you should configure the incipient environment This is the incipient screen 5 Home ij Patient E History SONOST 3000 Cc le T Auick 2 ag J m ese A 43 DailyTest information Home of the incipient screen There are Main buttons on the top line It is used when the screen is moved The bottom line is consisted of Sub buttons it is use for sub function Other screens are similar formation QuickMeasure Direct measuring function without patient s registration process DailyTest Daily test finction When the daily test is needed the color of button is red After it is need not the color of button is turn to same with others Setup Q nsists of finctions which are related with program setting Information Usplay information about the program and device OT00 2F0423 01 20 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 2 3 Setting of the Incipient Environment Click the lt Setup gt button on the Home Screen then environment window is appeared Settings System Cleaning Backup Patch Enter Hospital Name OED Setup Window lt Settings gt Fundamental settings related Software lt System gt Settings related Operating System lt Cleaning gt It makes probe is moved of user s own accord for cleaning lt Backup gt Control of measured data
20. e is 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 OT00 2F0423 01 44 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL D If the fuses are gone exchange the same type 250V T315AL Otherwise a fire may occur or you may receive electric shock _Fuse Holder 100 120V 1 Open the fuse drawer on the upper side of the appliance inlet there will be the two small fuse holder 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 7 Close the fuse the drawer FA ja Ya CAUTION For continuous protection against a risk of fire hazard replace only with same type and same rating of fuse OT00 2F0423 01 45 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 5 Ch
21. e packed in the replacement cartons Shipping and insurance costs for the return of the defective product must be pre paid by you 4 If you request the product information to repair the defective product yourself we provide you with the proper information This limited is in lieu of all other warranties expressed or implied including warranties of merchant ability or fitness for any particular use No representative or other person is authorized to represent or assume for OsteoSys Co Ltd any warranty liability beyond that set forth herein OT00 2F0423 01 5 4 A4 210 x 297
22. ecking 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 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 6 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 8 Check maintenance and repair 9 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 1 1 Others Read the user s instructions carefully and use the product properly OT00 2F0423 01 4 6 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Chapter 5 Specifications amp Software Updates 5 1 Specifica
23. foot size If you want to search the registered patient click the lt Search gt button on the bottom line and make it appear the Search Patient window It apply search condition of the patient s ID name gender and year of birth If you insert the related information and click the lt Ok gt button then the result is displayed on the screen Search Patient Window PatientID Search Result Window OT00 2F0423 01 2 8 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL L Measurement of Patients If you want to measure the patient s Bone Density select a desired patient in the Patient List screen and click the lt Measure gt button Then the Measure screen appears as shown below ID 99 Name 00 Time Frequency Measure Screen Click the lt Start gt button on the bottom of left Then the message box inquiring measuring site and so on If you select inquiring articles and click the lt Ok gt button ultrasound waves are generated from the probe Select Site Window When ultrasound waves are generated the lt Start gt button is changed into lt Stop gt button In case of emergency click this button and you can stop measuring In the normal condition ultrasound waves generation is finished OT00 2F0423 01 29 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation
24. l Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 2 4 Measurement of Bone Mineral Density BMD Measurement LI Patient Registration and Search If you click the lt patient gt button on the top line at the incipient screen you can move to Patient List which display and control the registered patient Left list mean registered patient s birth year If you click the year you can see the patient s ID and name list were bone in the same year j gt a Patient 4 History a Measure Year of Birth PatientID 9 2007 C 2005 2000 C 1999 C 1990 C 1975 C 1936 C 1935 2 1934 Patient List Window If you want to register a new patient then click the lt Add gt button on the bottom line Then Add Patient window is appeared which insert the patient s information If you insert and click the lt Ok gt button then patient is registered and displayed on the screen Add Patient Window PatientID Insert the ID which can identify the patient OT00 2F0423 01 27 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 64 characters are MAX Name Insert the patient s name 64 characters are MAX Year of Birth Insert the patient s year of birth Gender Insert the patient s gender Ethnicity Insert the patient s ethnicity Foot Supporter Choose the Foot Supporter according to the
25. mport If you click this button you can import the exported data OT00 2F0423 01 24 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 20040731 060650 All 20040731 060650 All 20040731 060844 Period 20040731 061053 Individual 20040731 071122 All 20040731 073954 Individual Setup gt Backup gt Import Window LJ Patch It is upgrade the Software Settings System Cleaning Backup Setup gt Patch Window At first Prepare a USB removable disk which support USB 1 1 You can use mp3 player or digital camera too Copy the patch file file name NK BIN to USB removable disk Insert USB removable disk into SONOST 3000 device s USB port OT00 2F0423 01 25 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Click File open button And select the patch file Generally USB removable disk is Hard Disk2 folder Click Patch button Cursor is changed to a sandglass Patch takes 5 10 minutes When patch is finished Patch Complete message is occurred Restart SONOST 3000 You can confirm by seeing software information at Home gt Information During patch if you turn off device or take USB removable disk off Critical problem will be occurred OT00 2F0423 01 26 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Mode
26. n OT00 2F0423 01 5 1 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 6 2 Reference Data Reference Data We achieved reference data from several group with different environment in Korea And the data is analyzed by statistical method yns i L i 20 24 25 29 30 34 35 39 40 44 45 49 50 54 55 59 60 64 B5 69 7O 7d 7 Age N 40 38 35 38 40 42 37 41 35 37 38 35_ Where we make the BQI Bone Quality Index by weighting sum of SOS BUA OT00 2F0423 01 5 2 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Chapter 7 Product Warranty Scope and Period of Warranty 1 OsteoSys Co Ltd guarantees all new product 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 OsteoSys Co Ltd will charge service fees in following cases If the product is out of order after the warranty period expires
27. n geen enn nn nnn GE ene n enna nnn nanan nnn nnn p anna nanny nnn E nnn gana nanan manana naan naan nanan nnn anna a ae E a ae a a ae a a ge a a a a e a wee wwe b ewww wenn dawn n anne daeeenenn ten nanaantaseennnnseesaassaswaneeneasbasaessnasdanananasdaaseesantacaaaaandassssensstensaaaaswassscssabasssasss DailyTest Screen al Whenever you calibrate the system you should use the QC Phantom gt included in the accessories list If you click the lt Start gt button on the bottom ultrasonic waves are generated and the word on the lt Start gt button is changed into lt Stop gt In case of emergency click this button and you can stop daily testing In the normal condition the message box Complete Dailytest appears as shown below with an alarm sound after progressing calibration of the system and if you click lt OK gt button the progress of calibration is completed OT00 2F0423 01 34 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Time Frequency y i pee eee In case of the screen shows the calibration has failed do not use the system and execute DailyTest once again If calibration fails continually contact to OsteoSys or its authorized dealer OT00 2F0423 01 35 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 2 8 Printing of clinic
28. nce 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 A A WARNING Warning is used to indicate the presence of hazard that can cause severe personal injury death or substantial property damage 1f the warning is ignored f AN i e i f CAUTION Caution is used to indicate the presence of hazard that will or can minor personal injury and property damage 1f the caution is ignored Note is used to notify the user of installation operation or maintenance information that is important but not hazard related OT00 2F0423 01 3 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL The symbols which are shown in this manual or SONOST 3000 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 Applied Part Type BF I and O on power switch represent ON and OFF respectively The Attention s
29. of probability as below 1 T lt 6 T gt 6 2 of 1 000 000 000 persons 2 T lt 5 T gt 5 3 8 of 100 000 000 persons OT00 2F0423 01 5 0 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 T lt 4 T gt 4 6 3 of 10 000 persons 4 T lt 3 T gt 3 2 7 of 1 000 persons 5 T lt 2 T gt 2 4 6 of 100 persons For example Person in T lt 3 exist 1 35 ratio of 1 000 persons in whole population 7Z Score Average BQI in the same age that is BQI standard deviation in the same age 1 More than 0 BMD is higher than the average of the same age 2 0 Average vale of he game ag 3 0 and below BMD is lower than the average of the same age Explanations of BUA Measurement MODE Terminology 1 PEAK Maximum value of signal in the frequency domain 2 Center Frequency Value of center frequency 3 Percent Bandwidth 3dB bandwidth Center Frequency X 100 Generally as these values are lower BUA values is higher Explanations of SOS Measurement MODE Terminology 1 Zero Point Cross point of the time Ox which is used for acquiring the signal s position 2 Gain Amplification degree of ultrasonic signal which is controlled automatically 3 Peak Maximum value of signal in the time domain 4 TOF Time Of Flight Elapsed time of ultrasonic signal from transmission to reception It is used for SOS calculatio
30. rents 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 OT00 2F0423 01 4 3 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Equipotential Connection Lead Terminal Socket i Main Body gt Equipotential Connector i _ Earth in Medical Room Try to place the system far from power generators X ray machines broadcasting stations and transmission lines to avoids electrical noise during scanning Otherwise abnormal images may result An independent circuit and a safely grounded outlets are strongly recommended for SONOST 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 4 Check followings while the devic
31. s information is revised Modify Patient Window LJ Deletion of Patient s Information If you want to delete the registered patients information select a desired patient in the Patient List screen and click the lt Delete gt button on the bottom Then the message box Delete Patient inquiring about the whether to delete the information surely appears and if you click the lt OK gt button the information is deleted Delete Patient Window OT00 2F0423 01 3 1 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 2 6 Inquiry and Deletion of Clinical History of Existing Patients LJ Inquiry of Clinical History of Existing Patients If you want to retrieve the clinical history of existing patients select a desired patient and click the lt History gt button on the top of the Patient List screen Then History List screen appears that contains the patient s clinical history as shown below On the right side the left and right foot s measurement results list shows If you select a measurement result in the list the relevant clinical history represented by a graph on the left side tn gt Home g Patient History Measure 2008 3 21 1 6 i 2008 53 21 1 5 Date T score History List Screen LI Detailed Representation of Clinical History of Existing Patients If you click the lt Detail gt
32. scccccesscees 16 3 1 4 Setting of Internal Printer scsesecsssesesesecesseseseseosesesesseseoooo 17 Del USME S W aroa A E 20 3 2 1 Progress Table of Program eeccccsssssceecoccsssssecccoccossssceccococossseceeeossssse 20 3 2 2 Ex c tfion 0f Propra siiisesieccndecsiiseuts iecccdacetaseseasieesdeasiicevtaveascdenseusedenenes 21 3 2 3 Setting of the Incipient Environment ccccccccccccccccccccsssecs 22 3 2 4 Measurement of Bone Mineral Density BMD Measurement 28 3 2 5 Revision and Deletion of Patient s Information ccccccssssssssees 32 3 2 6 Inquiry and Deletion of Clinical History of Existing Patients 33 3 2 7 Calibration of SONOST 3000 DailyTest ccssssssscccccccssssssscsees 34 3 2 8 Printing of clinical history and Resullt ssccsssssssssccccsssssssssssees 3 6 Chapter 4 Maintenance and Repair of SONOST 3000 ccsssssssessecccesseeeees 38 4 1 Resolution to Problems eecccossssscececccccsssscecococsssssccceccosssssscecosossssssceeesssssss 38 4 2 Maintenance and Repair scseidicceserssevcidsdeasiiebendassvsdieiesetesecctesctdisvencesexsaeieisiece 39 4 2 1 Cleaning Disinfection Sterilization eescccccoooosssssssssccecceccccosssossssssoo 39 A22 Product Ss LiG e E E 39 4 2 3 Stockpile and Replacement of Articles ssssececcoccssssseeeocccsssssceeesoossse 40 a OA SLOU AGE L ENSE EAA EAE NE E E EET EAE VE E O A T E 40
33. teoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Insert patient s foot after widen probe s gap enough because probe pad is made from soft silicon 3 1 2 Where and How Much Apply to the Patient s Heel Before measuring using alcohol to rub patient s heel protection for removing air bubbles surface of patient s skin and other infections Apply plenty of ultrasound gel to both side of patient s heel ENOUGH Ankle Jelly Good NOT ENOUGH No Good OT00 2F0423 01 15 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 1 3 Correct position for Patient s foot amp body Adhere a heel to the measuring device closely as shown 3 points below Make sure measuring device and body should be one line as shown below Device GOOD NO GOOD OT00 2F0423 01 1 6 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 3 1 4 Setting of Internal Printer Q Paper type Thermal paper width 58mm thickness MIN 0 07mm About 80 reports are printable by one roll Q Paper character Only printable in an outer surface LJ Purchasing Purchase from the headquarters or an agency LJ Paper inserting Cover opening Pull down open the dark gray cover on the device s the back side 2 Paper inserting Insert the paper
34. ter this procedure clean the stained area with a dry piece of cloth Probe endurance condition Levite Temperature range 40 C 70 C Humidity 0 90 Atmospheric pressure 50 106kPa External force 0 1N 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 Product s life This product s life is 7 years Except Accessory OT00 2F0423 01 39 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 4 2 3 Stockpile and Replacement of Articles P Make sure to keep following articles of consumption all the time 2 1 3 Articles List a Specifications Gel is a necessary article when measuring BMD Please purchase new one before it being out of stock 4 2 4 Storage Unplug the power cord Dust on the product can damage the system After use make sure to cover it with a vinyl cover Pany If the hardened gel remains in the device it can effect on BMD St hs results Please clean the device everyday 4 2 1 Cleaning Disinfection Sterilization Unplug the power cord Storage Put cover on the product to avoid dust fora Keep the product according to instructions described in 2 2 long Installation of SONOST 3000 time period 2 2 Installation of SONOST 3000 OT00 2F0423 01 40 A4 210 x 297 User s Manual
35. terial which prevents Alcohol ultrasound from progressing Result paper is printed at printer paper Printer Paper 2 rolls _ i Minimum paper thickness 0 07mm OT00 2F0423 01 14 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 2 2 Installation of SONOST 3000 Since SONOST3000 is made up of precise components you should install the product according to instructions below Do not install and keep SONOST3000 at Do not install or keep SONOST3000 in excessively high or low temperatures the place where the machine can be rocked or shaken Make sure to place Proper H Ad the system temperature ORE parallel to the 18 27 gt 28h ong floor bd Do not install the system in the place with Install SONOST3000 in the place where polluted air and high humidity and do not it is free from water or chemicals expose the machine to direct ray sunlight It is advisable to use SONOST3000 in the place equipped with air conditioning or heating Proper humidity 20 80 Do not share the power outlet with other For escaping from electronic noise do not products through an extension cord install near a electronic generator X ray equipment broadcasting equipment It causes a ml result to be Pre inaccurate x4 5 ON ei ge arm Eo p Do not cover ventilation of the system or 100 240V is usable When SONOST3000 place it near the wall
36. tions General Classification Class Type BF Applied part Device AC 100V 240V Input Voltage Free Voltage Single Phase Input Current 1A Class I Ultrasonic Probe Position Setting Variable Measurement 25 100mm Patient s Measurement Posture In a sitting posture OT00 2F0423 01 47 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Hnvironmental Operating Temperature 10 40C Transport Storage Temperature 10 70C Operating Humidity 30 75 relative humidity Transport Storage Humidity 0 90 relative humidity non condensing Atmosphere 700 1060 hPa Shock Not to exceed 2G in six millisecond Install system in a clean well ventilated area Excessive dust and other airborne Dust Fumes Airborne debris debris contaminants can impair sensitive parts We recommend instituting a No Smoking policy in system area OT00 2F0423 01 4 8 A4 210 x 297 User s Manual Confidential OsteoSys Co Ltd Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL 5 2 Software Updates 1 Updates to SONOST 3000 software are available at our homepage http www osteosys com 2 Updates to SONOST 3000 software are free regardless of the product warranty 3 Updates to SONOST 3000 software are irregular we will inform you through your email whenever SONOST 3000 software needs to be updated 4 For details
37. ymbol 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 The date of manufacture This symbol indicates caution for the hot surface OT00 2F0423 01 4 A4 210 x 297 User s Manual Confidential OsteoSys Co Lid Model Designation SONOST 3000 DOC No OT06 2R0422 00 MUL Table of Contents Chapter I Introduction snieni EEO 7 Chapter 2 Configuration of Device ssssssssseeccccccssssccececccssssscceecocsssssscececossssseceeeessssse 9 Zk COMPOSION of DEVICE acc cassiercscecsnceasesteyecseesnuccasscayessevancean staves seesnuccasscevessseonceasets 9 2 1 1 Shape and Components Of Device ccscccccssssssssssscsccccccccsssssssscccsees 9 2 L2 A CCOSSOVICS MAIS aeara aa araa 10 ZES ATAC ES LIS i E 11 2 2 Installation of SONOST 3000 csssssssccccccccscsccssssssssssssscssssssscccssssssseees 12 225 Before Turning oM POW EF aicsecesdccccscesiavecectesersctecaseceutestaseensaveccedvaececsc aiedeateseesee 13 Chapter s Usine SONOS T 3000 chien aan estima nahin 14 Dok Usmo B W reeni e a e aE EE 14 3 1 1 Patient Measurement Procedure ssssscccccssssssssssssssccccccccsssssseees 14 3 1 2 Where and How Much Apply to the Patient s heel sssssesees 15 3 1 3 Correct Position for Patient s Foot amp Bod y sccccccccsssss
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