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Omnisense 8000S User Manual - Pear Healthcare Solutions Inc.

1. Table 10 1 System access user privilege levels Type of User Privileges Operator Operators can add other operators to the User List They can remove only their own name from the list of operators They can change their own password They can access only unassociated patient data Physician Physicians can add the names of other physicians and other operators to the User List They can associate operators to them selves or disassociate them Operators may be associated with more than one physician Physicians may be associ ated with more than one operator They can remove only their own name from the list of operators They can change their own password System The System Administrator SA function Administrator is intended to insure that patient data is accessible in the event of an emergency such as absence of a patient s physician or a forgotten password When the sys tem is entered with the SA user ID one can open Administration gt Patient Man agement and unsecure any or all patients The data of all patients unse cured in this way will be freed of any access restrictions which may have applied See 10 4 Patient Manage ment page 10 20 for details User Guide 10 5 CHAPTER 10 10 2 System Administration Setting System Default Options Omnisense provides a screen for a description of your location general patient population and other items you may want the system to m
2. Hold the probe with both hands Fingers 1 3 of both hands grasp the probe near the base the surface applied to the scan area while fingers 4 5 palpate the limb during the scan and aid in guiding the movement of the probe correctly Only slight pressure should be used when applying the probe to the scan area 10 Press the foot pedal to begin the measurement cycle When the probe is in proper contact with the area to be scanned an audible signal is heard from Omnisense 11 The scan movement begins 3 to 4 centimeters medial to the Tibial crest and ends at the crest about 70 degrees of rota tion Move first towards the crest and then back to the start ing position repeating continuously until the measurement cycle completes Do not move the probe lateral to the crest One cycle of movement to the tibial crest and back again to the starting point should take 5 6 seconds 15 10 Sunlight Omnisense 7000S 8000S Correct scan procedure for the mid shaft tibia The skin mark is used to guide the scan Begin 3 4 centimeters medial to the tibial crest lower left scan toward the crest lower right and then back again until the measurement cycle completes Mid shaft Tibia Figure 15 11 Scanning the tibia To insure accurate and reproducible results note the following e The center mark on the probe should follow the marked line on the skin at all times e Never hold the probe at an angle to the surface
3. Adults Patient Measure Administration Research Help By Measurement By Patient Convert the required file to Excel via one of the following methods e In Excel open the required file using the All Files option in the Files of Type field of the Open dialog box then save the file in xls format or e Before opening the required file rename it with an xls extension The system will then recognize the file as an xls file Backup Restore The Backup Restore facility is provided as a security mecha nism It is intended to support restoration of data lost in the event of fire disk failure loss of a data volume or other undesir able event Regular backups reduce the probability of data loss due to events of this kind A Restore operation replaces the entire user database on Omnisense including patients patient measurement results users and System options The Backup Restore facility is not intended for use as a mecha nism to transfer data or systems from one machine to another See 16 1 Import and Export of Patient Data page 16 1 for more information on Omnisense facilities for transferring patient data between systems User Guide 16 9 CHAPTER 16 Utilities and Peripherals Backup Procedure STEP 1 Open the Backup dialog box Select Backup from the Administration menu The following dialog box is displayed Figure 16 4 Backup dialog box Administration gt Backup A Backu
4. In the frequency range used by Omnisense an ultrasound signal travels much faster through the relatively dense cortical layer of the bone than through the trabecular layer approximately 4000 m s vs 1800 m s The signal travels through soft tissue much more slowly than through either type of bone and propa gation through air is practically nonexistent Omnisense relies on this fact for its operation Probes Omnisense employs hand held probes to generate and detect ultrasound waves Each probe contains a number of transducers some of which serve as ultrasound signal generators while others function as detectors During measurement the probe is applied directly to the skin at the region of interest In case probe caps are used a layer of ultrasound gel is applied between the probe sur face and the probe cap A probe cap is mounted over the probe measuring surface with the cap s front skin is in a good contact 3 2 Sunlight Omnisense 7000S 8000S Omnisense Technology Omnipath with the ultrasound gel with no air bubbles showing Another uniform layer of ultrasound gel should be applied to the probe cap surface and the skin to facilitate good acoustic coupling Ultrasound is emitted by the generating transducers transmitted along the bone and then received at the detectors Ultrasound wave transmission with the Omnisense probe page 3 3 illus trates the functioning of the probe Figure 3 1 Ultrasound wave tra
5. Precision Studies Three types of in vivo precision studies were performed to eval uate various aspects of reproducibility of SOS measurements The objective of all three types of studies was to estimate the variability of in vivo SOS measurements of a human subject between device components different operators and with repeated measurements These measurements were repeated with all three types of probes CM which is used to measure the distal 1 3 radius and the mid shaft tibia CR which is used to measure the metatarsal V and CS which is used the measure the proximal phalanx V In each study reproducibility is mea sured by the coefficient of variation CV which is the standard deviation divided by the mean User Guide 2 11 CHAPTER 2 Essential Prescribing Information Reproducibility of Instruments and Probes In this type of study three main units four CM probes and three operators were evaluated to determine the reproducibility of each All possible combinations of each element system unit slot number and probe were tested for a total of 36 SOS measurements of the distal 1 3 radius of a single subject 3 sys tem units X 3 slots X 4 probes The reproducibility CV of the probes for a given combination of system and slot ranged from 0 36 to 0 90 0 29 overall The reproducibility of the sys tem units for a given combination of slot and probe ranged from 0 21 to 1 01 0 13 overall The reproducibili
6. 2 10 Patient Counseling Information Patient Counseling Information Information for Patient Brochures are supplied with the Omnisense Bone Sonometer These brochures give a brief sum mary of the importance of bone density testing and information about the Omnisense Bone Sonometer Conformance to Standards The Sunlight Omnisense 7000S 8000S Bone Sonometer con forms to U S and international standards as described below for safety electromagnetic compatibility and acoustic output relative to ultrasound devices The Sunlight Omnisense 7000S 8000S Bone Sonometer generates and emits ultrasonic energy Emissions have been tested and found to be in conform ance with the accepted standard limits for medical diagnostic devices of this type Non clinical testing demonstrated conformance to the follow ing international standards IEC 60601 1 EN 60601 1 Medical electrical equipment Part 1 General requirements for safety IEC 60601 1 2 EN 60601 1 2 Medical electrical equipment electromagnetic compatibility Requirements and tests IEC 61157 1993 Requirements for the declaration of the acous tic output of medical diagnostic ultrasonic equipment NEMA ID 2 revision 2 1997 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment FDA Guide 510 k Track 1 Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices 1985 and FDA 510 k Guidance Information for Manufacturers S
7. After performing Steps 1 3 at the beginning of your day the Omnisense measurement screen can remain displayed at all times For all subsequent measure ments these steps may be skipped except for open ing a new patient file unless you exit the measurement screen to perform Management opera tions See CHAPTER 5 5 1 Basic Operations on page 5 1 Chapter 10 System Administration and Chapter 15 Utilities and Peripherals for more detail on Management operations Select the site where SOS will be mea Once you have selected a patient you need to iden tify the site to be measured Move the cursor to the selection box labeled site Figure 8 1 on page 4 All activity now shifts to the right side of the screen until you complete the SOS measurement To choose the site scroll through the pop up list that appears in the box as shown in the figure at left As you click on different sites in the list notice that the large graphic at the right of the screen changes to display an anatomical representation of the site selected When your site has been selected the Probe field will automatically display the name of the correct probe to use The Probe field is located to the right of the site selection area 8 3 Locating the Measurement Site applied is an important part of preparing for an SOS Determining the exact location where the probe is to be measurement Measures of the speed of sound in bone depend s
8. e Quick Reference Guide only available in languages other than English All software is pre installed in the Omnisense unit If any of the components are damaged missing or different than those ordered contact Sunlight Customer Support as soon as possible Save the packing material in which Omnisense was shipped in case it must be moved to another location or returned for service Unpacking Omnisense 8000S Ensure that all components indicated on your packing list were received In some cases the items supplied may vary with your order type These are indicated Be sure to check your shipping order for special items or specifications e Omnisense 8000S Device and power supply cable e Keyboard with integrated mouse e One or two probes as per your order e Foot pedal with connecting cable e One System Quality Verification Phantom e Accessories per skeletal sites ordered e Formatted CD RW diskette e User Guide e Quick Reference Guide only available in languages other than English All software is pre installed in the Omnisense 8000S device User Guide 4 3 CHAPTER 4 4 3 4 3 1 Initial Setup If any of the components are damaged missing or different than those ordered contact Sunlight Customer Support as soon as possible Identifying System Components The figures which follow illustrate the components of your Omnisense System Review this material briefly to familiarize yourself
9. 0 00 002 c eee eee 9 6 Patient risk assessment 00 0c eee eee ees 9 7 Patient measurement details 2 0 0 cece eee eee 9 8 Patient measurement delete measurement result 9 9 Multiple sites measurement screen 0 0 0 e eee eee 9 11 Multi site measurement site listing 00 0 0 e eee 9 12 First site measurement result 00 cee eee eee 9 12 Select a second site for measurement 00005 9 13 Example of a multi site measurement report 9 15 Measurement history screen 0 0 0 cece cece eee 9 16 Users List dialog box Srana ar a eens 10 2 Add User dialog box ciciau eiro a a Ae 10 2 Duplicate name warning 2 2 2 eee eee 10 3 Delete user ID warning 0 0 0 eens 10 4 System Options dialog box Defaults screen 10 6 System Options dialog box Settings screen 10 9 System Options dialog box Scheduler screen 10 11 System Options dialog box License screen 10 15 Figure 10 9 Figure 10 10 Figure 10 11 Figure 10 12 Figure 10 13 Figure 10 14 Figure 10 15 Figure 10 16 Figure 10 17 Figure 10 18 Figure 10 19 Figure 15 1 Figure 15 2 Figure 15 3 Figure 15 4 Figure 15 5 Figure 15 6 Figure 15 7 Figure 15 8 Figure 15 9 Figure 15 10 Figure 15 11 Figure 15 12 Figure 15 13 Figure 15 14 Figure 15 15 Figure 15 16 Figure 15 17 Figure 15 18 Figure 15 19 Figure
10. 14 2 1 Technical Specifications for 7000S Table 14 1 Omnisense specifications Parameter Specification Measurement Speed of Sound SOS Technology Ultrasound Omnipath Axial Trans mission Probes Proprietary multi transducer probe family Center frequency 1 25 MHz Measurement RMS CV 0 4 to 0 8 in vivo Precision amp Accu precision depending on site racy 0 25 to 0 5 instrumental accu racy depending on probe User Guide 14 1 CHAPTER 14 System Specifications Parameter Measurement Time Specification Approximately 1 minute per skele tal site User Interface Convenient keyboard and mouse Calibration Display Options Calibration free Daily System Quality Verification procedure with phantom is recommended Flat color display monitor LCD Regulations IEC 60601 1 IEC 60601 1 2 Class B UL 2601 Part 15 of the FCC rules Type B Class 1 Certifications Specifications CE 0344 Mark UL Mark IEC 60601 1 Type B Class 1 IPXO The UL classification for Omnisense is Class 1 Equipment Power 100 240VAC Autoswitchable 50Hz to 60Hz Power Consump tion Approx 85 VA including LCD dis play 80 VA system alone Operating envi ronment 14 2 Sunlight Omnisense 7000S 8000S Temperature 10 to 35 C 50 95 F Humidity 30 to 75 non con densing Technical Specifications Parameter Specification Storage and tran
11. Distributor screen Administration gt Options gt Distributor A Options x Defaults Settings Scheduler License Distributor Distibutorf a Addes S Phone o y O LOOO yO E mail FC O O OK or Cancel h 10 3 User Interface Language Selection Omnisense permits the selection of several languages for the user interface Language selection is accessed by selecting Administration gt Options gt Settings gt Language amp Regional in the Administration Menu This operation opens a two part form Language and Regional Settings Only available languages are shown User Guide 10 17 CHAPTER 10 System Administration Figure 10 12 Language and Regional settings Administration gt Options gt Settings gt Language amp Regional A Language amp Regional Lanquage Regional Settings English Australia Eis English Belize Y Ls English Canada English Deutsch English Caribbean Kenca English Ireland E Selected English Jamaica English New Zealand English Philippines English South Africa English Trinidad istess Franesic Decimal Symbol Date Format Time Format 6 27 09 10 2004 15 41 13 Calendar type OK or Cancel A Select the language desired in the Language section on the left The device will ask you if you want to change the regional set tings correspondingly It is suggested that you answer Yes in this window to change the regional se
12. If the Result button does not become active after three cycles this indicates that one or more of the measurement cycles yielded statistically inconsis tent results and is not usable Repeat for another measurement cycle Omnisense will allow up to five cycles if three consistent measurement cycles User Guide 6 9 CHAPTER 6 System Quality Verification have not been obtained after five cycles the mea surement is aborted and the counter cycles back to 1 In this case you must begin again and attempt three new cycles If the results of measurement cycles are not being accepted by Omnisense check that no air bubbles are being trapped between the probe and the phantom and that sufficient ultrasound gel has been applied If results are still not being accepted your probe may be defective Contact Sunlight Customer Support STEP 11 Go to Result Click on the Result button and the following is dis played Figure 6 7 Entering the expected phantom SOS value SQV Measurement gt Result A Enter expected phantom 505 Enter phantom SOS OK Min Max 2700 2800 Enter value and OK h Enter the number noted in Step 5 and click OK STEP 12 Check the result The result is displayed graphically along with results from recent System Quality Verifications as illustrated in Figure 6 8 6 10 Sunlight Omnisense 7000S 8000S Performing System Quality Verification STEP 13 Print Result If desired
13. Similarly cautionary warnings are indicated with the icon and style below Warning and safety information will be indicated in this style Screens Snapshots of screens and dialog windows as they appear when using the Omnisense software are found throughout this Guide Screens are preceded by a rule and caption header You can find out how to enter and exit a screen by looking at the far right of the figure just above and just below the screen respectively The screen format is illustrated below Figure 1 1 Example screen Ee N lt c Administration gt User List A This line indi cates how to enter the screen Explanations of items on the screen will appear here where required This line indi cates how to exit User List x Physician Name Operator Name Add Amenda Add Jerry an O Amy Aid 4 OK Smith O Jerry M Rose Smith Remove Remove C Apriy Associate Current user sunlight Change password the screen I E OK or Cancel Vv User Guide 1 7 CHAPTER 1 Using this Guide The entry and exit indications are specified as a sequence of actions separated by angled brackets as illustrated by the exam ples below Administration gt User List means choose the item User List from the Admin istration menu Patient gt Show History or Toolbar gt History means there are two ways to enter either select Show History from
14. filling next mea surement is within the reminder period OK Edit or Print A The Visit Database displays two types of patients e Patients whose next measurement dates are within the default reminder period 10 2 Setting System Default Options page 10 6 and have not been checked as con firmed in the Scheduler form These patients records are tagged with a yellow icon meaning that they should be notified of their upcoming measurement e Patients whose scheduled measurement date has passed by more than the default Post Due Date Period 10 2 Setting System Default Options page 10 6 These patients records are tagged with a red icon meaning that their measurements should be urgently rescheduled The user can print the patient scheduler list by selecting the Print button A report example is illustrated in Figure 7 13 7 20 Sunlight Omnisense 7000S 8000S Tracking Down a Patient s Measurements Figure 7 13 Patient Schedule Report example Print button Dr Jeremy Davidson Paget 577 South St Suite 132 Phone 212 6754322 Fax 212 6754321 E mail info davidson com Sunlight Omnisense Patient schedule report Date 29 03 01 Operator sunlight Family First Last Phone Address Remark name name visit number Smith Pamela 30 01 01 44 1 234235 Oxford 6 London UK WASILEWSKI JAN 26 09 00 0048 68 8877766 Krakow Poland Watson Will
15. select the drive to which the patient data are to be written Insert a disk with sufficient free space into the selected drive To see how much free space is available on the volume selected click on the Read button and observe the Free Space field at the bot tom left of the window Specify the patient data to be exported Click successively on the lines in the center window to select multiple records If you change your mind about a selection you can unselect by clicking over a selection or start over by clicking Unselect All Use Select All if you want to export the entire data base Checking Use Security will cause security informa tion to be transferred with the exported patient data That is any patients associated with specific User Guide 16 5 CHAPTER 16 16 2 Utilities and Peripherals physicians and restricted to viewing by those physi cians will also be so restricted on the Omnisense machine which imports the data STEP 4 Execute the Export Click OK and the data are written to the export vol ume If you have exported data to a CD RW diskette click on Eject in the Administration menu to eject the diskette Data Conversion Omnisense enables the conversion of a patient database into an output format compatible with Excel The conversion to Excel feature is actually a conversion of the system s data into text tab delimited The user may select between two optional formats e Measurement
16. version for off line analysis is also supported 17 1 The Research Mode screen Research Mode is distinguished from the Clinical version of the Omnisense screen by three additional features as illustrated in Figure 17 1 Figure 17 1 Omnisense Research Mode screen Default in Research Mode A Probe Mapping Sunlight Omnisense Adults Patient Administration Research R amp D Help m S toa Probes Al E Single Site J Site X 4 PROXIMAL PHALANX III Probe BES Research Menu Measurement Typ Patient Information Measurement Elapsed Time 1 25 First Name Sane Research information 808 Min SOS 3512 Average SOS 3766 Mex SOS 4085 r Probe Location Status Min 75 THRE E Proximal Tilt Angle 0 0 T2 R1 f Phalanx IlI Mex 75 TI AI E Left Depth Right Depth A F Reg0 Reg1 00 p oo C Reg2 C Reg3 Bad signal User Guide 17 1 CHAPTER 17 Research Mode These additional features are described in the table below Table 17 1 Omnisense Research screen additions Screen feature Function Probe Mapping These indicate for each slot on Omnisense s front panel whether or not a probe is properly connected Research The Research Menu offers additional Menu functions which relate to User Sites R D Help User Reference Databases and Result Edit Site Fe Conversion All Sunlight defined skele Copy Site
17. 25th per centile Measurements are sorted by patient Each line represents one patient Multiple measurements performed on the same patient User Guide 16 7 CHAPTER 16 Utilities and Peripherals on the same site and on the same date will not appear except for the latest measurement on each date The file contains the following list of columns in the following order Column head ings titles are printed at the first line Empty fields are marked N A List of columns in the by Patient file 1 2 3 4 9 12 13 16 17 20 21 22 23 24 28 29 30 PATCODE FAMILY NAME VISITDA BIRTHDA SEX HEIGHT WEIGHT SOS T SCORE Z SCORE REFERENCE MPAge FRACTURE MEDICATIONS BWEEK ILLNESS Patient ID Last name family name First name Measurement Date according to regional set tings e g DD MM YY Date of Birth according to regional settings e g DD MM YY Gender Height cm Weight kg Max SOS R T M P T Score R T M P Z Score R T M P Ref database Menopause Age Fracture History Hip Spine Wrist Medication first five Week of Birth Pediatric application only Diseases and Disorders text up to 255 characters Indicates data added in Research systems 16 8 Sunlight Omnisense 7000S 8000S 16 3 Backup Restore Figure 16 3 Data conversion menu Research gt Convert Results gt By Measurement or By Patient A Sunlight Omnisense
18. 8 5 Preparing the Environment for a Patient 8 1 Readying Omnisense for an SOS Measurement at Aar wl i tines tae ties Wid yack meena E See 8 3 Locating the Measurement Site 8 6 Understanding the Omnisense Measurement Screen i ed cuss Seals was bee eh eae 8 9 Measuring SOS at the Radius 8 16 9 Interpreting the Results of a Measurement 9 1 9 1 Viewing Measurement Results 9 1 9 2 Deleting a Measurement Result 9 8 9 3 Multi Site Measurements 9 9 9 4 Measurement History 0 9 16 10 System Administration 10 1 10 1 User Access Levels 2220055 10 1 10 2 Setting System Default Options 10 6 10 3 User Interface Language Selection 10 17 10 4 Patient Management 10 20 10 5 Probe Quality History 10 22 10 6 Changing Site Order 4 10 24 10 7 Extending or Upgrading an Omnisense License Bid eves E AA Oh Uae Sra E 8 10 26 11 The Sunlight Desktop 11 1 11 1 Installation secs ec2ccver sate veeseses 11 1 11 2 Adding and Removing Applications 11 2 11 3 Desktop Utilities 11 5 xiii xiv 12 13 14 15 16 Cleaning and Disinfecting Omnisense 12 1 12 1 Cleaning and Disinfection 12 1 Troubleshooting 13 1 System Specifications 14 1 14 1 General isso 2 eu aden oa aid Sete 14 1 14 2 Technical Specifications
19. Cancel Equivalent to Exit Does not undo data which has been entered and checked OK To change entries in a database use Edit When using the Reference DB Builder dialog box the general procedure is as follows Build Database procedure STEP 1 Enter general information First enter basic information on the population select the site measured fill in a name check appro priate boxes for gender and options and select or type the reference DB name STEP 2 Enter age related DB values Next click on the finger button at the bottom cen ter of the screen The fields just entered become greyed out the fields at the bottom left Age and Step become active 17 12 Sunlight Omnisense 7000S 8000S Working with Reference Databases STEP 3 STEP 4 STEP 5 Enter the first starting Age and the Step value and click on the right arrow You will be prompted to check that the data entered are correct Check that they are and answer OK The Age and Step fields become greyed out and the Norm and SD fields become active Enter values for Norm and SD and then click on the arrow again Repeat for each age interval With each click of the right arrow the Age field advances by the amount of the Step field and you enter Norm and SD values for that age range With the next click of the right arrow you move on to the next age range After entering Norm and SD for the last age range click OK If you mist
20. Determining the area to be scanned 2 To find the correct scanning area first use the right angled L gauge supplied with Omnisense to measure the phalanx as described below The gauge is illustrated in Figure 15 1 Figure 15 1 L gauge for measuring the phalanx Bend the patient s third finger so that the medial phalanx is at right angles to the proximal phalanx Fit the gauge to the patient s finger so that the right angle of the gauge fits over the right angle made by the medial and proximal phalanges The shorter leg of the gauge should hold to the proximal phalanx while the longer leg of the gauge is against the medial phalanx The correct gauge posi tion is illustrated in Figure 14 2 Figure 15 2 Correct position of gauge for measuring the phalanx Medial Proximal 15 2 Sunlight Omnisense 7000S 8000S Illustration of mark on proximal phalanx The Proximal Phalanx of the Third Finger 3 Note the length of the medial phalanx on the scale on the longer leg of the gauge Find the same unit of length on the proximal phalanx using the scale on the shorter leg of the gauge and mark the point with a skin marker Ensure that the proximal phalanx joint is behind the mark Continue drawing the mark around the finger to one half the circum ference of the phalanx i e the entire dorsal side Figure 15 3 Marking the scan position 4 Position the patient s hand face down on the desk i
21. The Patient Management dia log box allows a physician to view and change the security sta tus of all of his or her patients at a glance Figure 10 14 illustrates this dialog box 10 20 Sunlight Omnisense 7000S 8000S Patient Management Figure 10 14 Patient Management dialog box Administration gt Patient Management A Patient Management Security JID Lastname Firstname mi Secure 38756348 Jackson Helen d Unsecure Test Test Test Unsecure 64528298 Smith Jane Unsecure 56799239 Johnson Amy Unsecure 57487134 Lasko FIs AEA A Unsecure the currently selected patient Secure all patients Unsecure all patients OK or Cancel v A patient who has been secured is not accessible and does not appear to other physicians or operators on either the Patient List or the Patient Management dialog box except such operators as have been associated with the patient s physician Buttons at the right are used to secure a selected patient secure all patients in the list with a single mouse click or unsecure all patients respectively Clicking OK saves any changes clicking Cancel causes any changes made in the dialog box to be ignored Patients who have not been secured by any physician will be visible to all physicians and will be secured by the first physi cian who does so User Guide 10 21 CHAPTER 10 10 5 System Administration Probe Quality History In certain situations you may wish to review the
22. To access them com plete or abort the current measurement if a measurement is in progress save or abort the results and close the current patient file if open Three of the operations listed below are not specifically Measurement or Man agement related and are available whether or not a patient file is open These are Set Measurement Type Set Skeletal Site and Open Close Patient Enter Exit Omnisense 5 6 Sunlight Omnisense 7000S 8000S To shut down Omnisense select Exit from the Patient menu The Exit function is also used when you wish to enter the Omnisense system with a different user ID The procedure is described later in this chapter CHAP TER 5 5 2 Changing Users and Shut down on page 5 12 Exit Entry are not accessible when a patient file is open Basic Operations Management Operations Function Description Set Measure There are three Measurement Types ment Type Single Site Multi Site and System Qual also a Mea ity Verification surement All SOS measurements of bone are con operation ducted with the first or the second type See CHAPTER 8 Patient SOS Mea surement page 8 1 and 9 3 Multi Site Measurements page 9 9 for details System Quality Verification must be con ducted once daily preferably at the beginning of each working day to insure that probes and the system are operating with no problems CHAPTER 6 System Quality Verification page 6 1 desc
23. menu header as described in CHAPTER 8 Readying Omnisense on page 8 3 The following terms will be helpful e A scan refers to the actual movement of the probe at the skeletal site e Scan movements are repeated continuously typically 4 5 times to complete a single measurement cycle e A complete SOS site measurement consists of a minimum of three cycles To insure a statistically meaningful outcome the Omnisense software requires at least three measurement cycles These are combined through a proprietary averaging formula into a sin gle final SOS value called the measurement result CHAPTER 8 Patient SOS Measurement Figure 8 5 Omnisense screen indicators for SOS measurement Measurement A Cycle counter Elapsed time indicator Sunlight Omnisense Adults 1 DISTAL RADIUS Acoustic Signal Acquisition Indicator peen faa Traffic Light FamilyName Smythe i First Name Samanna SS Date of Birth 01 02 1950 Gender Female Elapsed Time 0 02 Height 167 0 cm Weight 68 00 kg BMI 24 Acoustic contact indi cator Electric Transmission 80 120 160 200 240 280 Progress bar 09 29 57 Start Restart Next Cycle Abort Goto view result Result button h As seen in Figure 8 5 at the top right of the screen the current cycle number is displayed out of a total of five possible Three consistent cycles are cycles which exhibit adequ
24. particularly the third finger CHAPTER 8 Patient SOS Measurement Figure 8 3 Measuring the Radius Use of the gauge to measure the Radius Measure to the tip of the finger not the tip of the nail STEP 3 Mark the exact half point Note the measured length from the gauge platform to the tip of the middle finger Do not include nail length in the measurement Draw a line at exactly half the measured length with a skin marker The line should be drawn on the radial surface perpen dicular to the direction of the bone Extend the line straight across the Radius to half the diameter of the arm Figure 8 4 Marking the Radius Correct marking pro cedure for the Radius From left to right Mark the exact half point of the measured length of the Radius Extend the mark straight across the Radius to half the diameter of the arm Sunlight Omnisense 7000S 8000S 8 8 8 9 8 4 User Guide Understanding the Omnisense Measurement Screen Understanding the Omnisense Measurement Screen The final part of the procedure for SOS measurement at the Radius is given in the next section Before continuing to that procedure this section explains in detail the indicators which display on the Omnisense screen during the SOS measurement procedure You will need these indicators to complete measure ment of the Radius If this is the first SOS measurement of the day click on the Measurement button or select the Measure
25. the Patient menu or click on the History button on the toolbar Measure gt Start 1 8 Sunlight Omnisense 7000S 8000S means enter Measure ment Mode and then click on the Start button Conventions Used in this Guide Important Symbols and Labels A number of internationally recognized symbols are found on the Omnisense unit These relate to safety requirements and standards and are briefly reviewed below Table 1 1 International Symbols on Omnisense Symbol Meaning Attention consult accompanying docu A N ments Type B equipment symbol CE Mark Indicates the Sunlight C er Omnisense 7000S 8000S complies with both the European Electromagnetic Com patibility EMC standard and the Council Directive 93 42 EEC MDD User Guide 1 9 ASPAR Essential Prescribing Information 2 1 The Sunlight Omnisense 7000S 8000S Ultrasound Bone Sonometer is an accurate and easy to use tool for assessing the condition of bone This chapter provides an introductory over view of the Omnisense system and the Information for Pre scribers Caution U S Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner Device Description The Sunlight Omnisense 7000S 8000S Omnisense Ultra sound Bone Sonometer is a non invasive ultrasound device capable of measuring bone speed of sound SOS at one or more skeletal sites It is comprised of a Main Unit an
26. the SQV result can be printed at this point by pressing the Print button on the toolbar seen at left Figure 6 8 SQV result screen SQV Measurement gt Result A An SQV result in either of these ranges is acceptable An ad Patient el Administration Research Help result in Re either of Hilal these Measurement Type W System Quality Verification Tana ranges is not accept Patient Information Probe Quality History Graph able Patient ID i Family Name i First Name 1 No prok Probe Quality Data Probe quality measurements Date SOs Norm fpayoreo0a ferae prsa f a 8 eS a 7 SS Ea PS ea S ea 2 SS ee Ss Se 5 a S505 Current SOS result Norm Expected SOS result Diff Difference between current and expected result 100 09 07 2004 20 07 2003 08 45 56 Change Measurement Type or Open Patient v As illustrated in the figure a result within either of the colored bands indicates a properly functioning system A result in the white area either above or below the colored bands indicates a problem with User Guide 6 11 CHAPTER 6 System Quality Verification the probe and it should not be used Contact Sun light customer support before attempting any SOS measurements which require that probe Remember to repeat the verification procedure for each probe you plan to use 6 12 Sunlight Omnisense 7000S 8000S on we wed Pa
27. 13 Troubleshooting Potential problems and suggested solutions CHAPTER 14 System Specifications Product specifications CHAPTER 15 Site Measurement Methodologies This chapter describes the correct method for measuring SOS at all supported skeletal sites and details the practice mode which enables the user to check his or her measure ment quality CHAPTER 16 Utilities and Peripherals Describes utilities provided with Omnisense for connecting to printers importing and exporting patient data backing up and restoring a system data storage operations software upgrade and more CHAPTER 17 Research Mode The Sunlight Omnisense 7000S 8000S Research version provides support for the investigation of new skeletal sites and the extension of reference databases This chapter describes these facilities CHAPTER 18 Keyboard Shortcuts Explains how to operate the system only by using the key board if and when desired User Guide 1 3 CHAPTER 1 1 2 Using this Guide Sunlight recommends that you read the rest of this chapter before using Omnisense It reviews the conventions used in this Guide information which will make your learning about Omnisense more efficient CHAPTER 2 Essential Prescribing Information covers important information on the use of Omnisense in a clinical set ting including background on clinical studies and the relation ship of Omnisense results to other methods of bone assessm
28. 32 e The user can print the practice session results or data but these cannot be saved If the Save button is pressed a pop up dialog box opens reading The Practice results data cannot be saved e Ifthe software license is of a Pay Per Scan type the fol lowing restrictions apply e The user cannot print the practice results or data e Both the measurement results graph and the T and Z scores are not available Resetting your CV scores If you wish to see your improvement over time you should reset the CV score after several trials and begin again Other wise the system will keep averaging your previous bad User Guide 15 19 CHAPTER 15 Site Measurement Methodologies scores against the new ones lowering your overall score Reset ting your CV scores is done by exiting the practice mode and re entering it 15 20 Sunlight Omnisense 7000S 8000S Utilities and Peripherals 16 1 This chapter reviews auxiliary features and functions which are provided to make Omnisense s use in a clinical setting more convenient If you need to install a printer you will find instruc tions for doing so in this chapter In addition there are utilities for backing up the patient data on your disks compressing the data so you can make better use of the media you have export ing and importing data to and from outside sources of clinical patient information and other utilities The utilities Back
29. 4 5 seconds Figure 15 7 The range of probe movement during the scan User Guide 15 5 CHAPTER 15 Site Measurement Methodologies To ensure accurate and reproducible results note the Q following e One end of the probe surface should follow the marked point on the skin at all times e Never hold the probe at an angle to the surface of the limb The probe should be held so that the short dimension of its surface is tangent to the bone while its long dimension is parallel to the bone axis e Do not use a circular motion The probe movement should follow parallel to the marked line e Scan approximately 180 degrees but no further e Check to ensure that a scan movement through 180 degrees takes about 4 5 seconds The scan is being conducted too slowly or too quickly if the movement takes longer or shorter respectively than this amount of time e Maintain the probe s surface in contact with the patient s skin throughout the scan No part of the probe surface should be raised from the skin at any point during the scan e Avoid climbing with the probe over the small bulge found at the proximal medial end of the Proximal Phalanx III e Do not press hard Additional pressure does not contribute any improvement in acoustic contact e During the measurement cycle concentrate on the site and correct application of the probe Avoid looking at the screen Use the audible signal to provide feedback and guide you in
30. Another PC You may also format a CD RW disk with another PC if it is equipped with Direct CD software from Easy CD Creator To do so insert the CD RW disk into the CD slot in the PC and follow the instructions on the screen This is a standard dialog window for formatting a 3 5 inch dis kette These often come pre formatted in which case they may be used without formatting If you have an unformatted dis kette or one whose directory has become corrupted use this disk format facility Select Format Diskette from the Administration menu The dia 16 20 Sunlight Omnisense 7000S 8000S 16 6 Other Utilities log box shown below is displayed Enter your choices as indi cated and click on Start Other Utilities Utilities to repair the device database and clear the device printer log are provided with your Omnisense device as well as a utility for printing Omnisense screens Database Repair Another tool available on the Omnisense device for your con venience is a database repair tool In cases where you find that the database on your device is not functioning correctly per haps because the device was shut down improperly click Administration gt Repair Tools gt Database The database repair will then proceed automatically When it is complete restart your computer to use the database as usual Clear Printer Queue The Clear Printer Queue utility is available for situations in which an operator has inadvertently
31. Estimated disk usage after defragmentation Analyze Defragment Pause Stop I Fragmented files W Contiguous files E Unmovable files Free space Analyze or Defragment or File gt Exit v Select the drive to be defragmented and click Defragment When the process is complete click File gt Exit in the Disk Defragmenter window to close the window and return to the Omnisense screen Format Disk Additional CD RW disks that you may have purchased outside of Sunlight are always un formatted and require formatting for use The formatting procedure described below is used both for the CD RW disk supplied with the 16 18 Sunlight Omnisense 7000S 8000S Disk Utilities device and for any CD RW disks purchased outside of Sunlight Formatting a 31 2 inch Diskette Using Omnisense 1 Insert the 31 2 inch diskette into its drive at the left side of the device Select Format Diskette from the Administration menu 2 Choose the drive which contains the disk to be formatted 3 Choose Capacity Format Type and other options if desired Click Start and the formatting process will begin 4 A message box will indicate to you that the format is in progress When the format is complete another message box will inform you that the diskette is ready Figure 16 9 Format dialog box Administration gt Format Diskette A Format 3 Floppy A REI Capacity 144 Mb 3 5 Start Quick erase
32. Figure 9 13 Figure 10 1 Figure 10 2 Figure 10 3 Figure 10 4 Figure 10 5 Figure 10 6 Figure 10 7 Figure 10 8 xviii Prescription drugs editing screen 0 00 00 eee eee eee 7 13 Opening a patient file 0 2 2 2k eee ee 7 14 Eistof Patients 0i5 cn0sr ge mori nae ee nia aa w 7 16 Delete Patient menu 2 0 cee eee eee 7 17 List of Patients with Delete button 0 0000 7 18 Delete patient warning 00 c eee eee eee 7 18 Selecting Scheduler report list 20 0 0 cee eee eee 7 19 Schedulerreport list ssu eden ee we ele wa iene a oa eo oa 7 20 Patient Schedule Report example 00 000 e eee 7 21 Opening a patient fille 2 ccc eee eens 8 4 SQV warning dialog box 1 0 eee eee 8 4 Measuring the radius 1 0 ccc eee nes 8 8 Marking the radius 0 2 02 eee eee ees 8 8 Omnisense screen indicators for SOS measurement 8 10 Progress bar during measurement cycle 005 8 13 Measurement cycle completed 00 cece eee eee 8 14 Hand rest and correct patient positioning 0 8 18 Applying ultrasound gel 0 20 2 eee ee nee 8 18 Scanning the radius 0 0 eee 8 19 SOS measurement result screen 2 0 0 eee eee eee 9 1 Suggest to re measure pop up box 00 00 c ee eee eee 9 4 Warning before discarding measurement result 9 5 Example of a measurement report
33. LCD temperature indicator on one side and a conversion table on the other Hold the phantom at either end and note the position on the scale which is green or blue green in color Turn the phantom over and find the SOS value in the table which corresponds to the temperature just read Note this number down phantom temperature between 15 and 30 degrees j N System Quality Verification must be conducted with the Centigrade 59 86 degrees Fahrenheit STEP 6 STEP 7 Outside of the range 15 30 C 59 86 F the LCD display will not provide a reading The phantom material conducts heat slowly therefore it may take some time to stabilize to room temperature Wait until a reading can be obtained before continuing with the SQV procedure Prepare probe Locate the probe and spread an even layer of ultra sound gel on its surface Position the phantom and probe Hold the probe in a vertical position active surface facing upwards and place the phantom directly on top of it as seen in the figure below User Guide 6 5 CHAPTER 6 System Quality Verification Figure 6 3 The phantom rests on the probe the probe is held steady without moving throughout the SOS measurement STEP 8 Positioning the phantom on the probe for SQV z 7 TULUHHUULUULLLLULULULULL t ben fe Wen Ben hl hd a Bon Bd a Bev Baa Boa baa Hd Bl ad Check for acoustic coupling To ensure effective coupling between the probe and pha
34. Move the probe about 70 degrees first to the lateral side and then the same amount to the medial side so that the probe executes an arc of about 140 degrees One full probe movement i e a distance of 140 degrees in one direction should take 4 5 sec onds Figure 8 10 Scanning the Radius i Correct scan procedure for the Radius Top row photos first from left to right 1 Scan begins with probe vertical to the positioned arm 2 Scan by moving first to the lateral direction about 70 degrees 3 Continue the scan by returning the probe to the starting point 4 Then scan in the opposite medial direction about 70 degrees and finally return again to start point Repeat until measurement cycle is complete To insure accurate and reproducible results note the following e The edge of the probe toward the palm side should follow the marked line on the skin at all times Sunlight Omnisense 7000S 8000S 8 20 8 21 User Guide Measuring SOS at the Radius e Never hold the probe at an angle to the surface of the limb maintain the surface of the probe perpendicular to the bone at all times e Do not hold the probe with only one hand e Do not use a circular motion The probe movement should follow parallel to the marked line e The probe must be moved across the full range of 140 degrees around the axis of the bone while maintaining a position perpendicular to the bone Do not merely til
35. Omnisense 7000S 8000S 2 7 6 Clinical Studies The same magnitude of improvement was found using the ORI in other cross sectional studies ORI a Short Discussion ORI was verified in a cross sectional studies as generally improving the discrimination relative to the individual building blocks T Site 1 and T Site 2 It was also found that the population standard deviation of the multi site index is smaller than both the SD of the single sites This narrowing presumably will improve the individual diagno sis and the sensitivity of the measurement Concerning speci ficity improvement of the AUC showed that it has increased without loss of sensitivity Patient Risk Assessment Index Ultrasound measurements predict clinical fractures in older women and men Risk of fracture shows a continuous gradient relationship with bone quality there is no true fracture thresh old To assess the risk of osteoporotic fractures results can be stated in terms of relative risk of fracture per SD change in bone SOS Based on Omnisense scientific literature and previous publica tions of relative risk and assuming that for each given age and gender group the ten year probability of fracture is known a new parameter computed from bone SOS and additional data has been introduced in the Omnisense software This parameter the Patient Risk Assessment Index provides the physician with ten year absolute risk for any osteoporo
36. Reference Database together with the patient s results including all avail able history The patient s T scores and Z scores are also shown in the left hand side results table When printing the printed output shows the Multi Site measurement curve and its results including history and the numerical results of the sites mea sured 9 10 Sunlight Omnisense 7000S 8000S Multi Site Measurements Please note that ORI calculation cannot be carried out for male patients To operate the Omnisense Multi Site measurement feature fol low the steps described below 1 Open the file of the patient to be measured 2 Select Multi Site in the Measurement Type pull down menu Observe that the Site pull down menu changes its name to ORI In the ORI pull down menu select a pair of sites to be measured You may choose any pair combination of the four sites gt In the menu bar icons click on the Measure button A measurement screen showing the two sites to be measured will open next to the Patient Information window see 9 8 on page 9 11 Figure 9 8 Multiple sites measurement screen Measure ment Type EI Multi Site Patient Information Paien pa a Family Name Smythe First Name Samantha Date of Birth 01702 1950 Gender Female Height 167 0 cm Weight es00 kg BMI 24 5 Click on the Start b
37. Sunlight Omnisense 7000S 8000S Identifying System Components 9 AC power inlet 10 Printer output 11 Monitor data socket 12 COM2 not used 13 Foot pedal socket COM1 14 Additional Grounding earth connector When conducting an SOS measurement the examiner uses a hand held probe at the area of interest applied directly to the patient s skin 4 3 2 Identifying System Components for Omnisense 8000S The next figures illustrate the Omnisense 8000S device front side and rear panels Verify that the unit you received has con nectors and features as described below User Guide 4 7 CHAPTER 4 Initial Setup Figure 4 3 Omnisense 8000S main unit front view Figure 4 4 Omnisense 8000S main unit side view 1 Table 4 3 Side Panel Drives 1 3 5 diskette slot 2 CD RW drive slot 3 PCMCIA slot 4 8 Sunlight Omnisense 7000S 8000S Identifying System Components The probes used for scanning skeletal sites and all other cables and connectors connect to sockets and ports on the rear panel see Figure 4 5 Omnisense 8000S main unit rear view page 4 9 Familiarize yourself with the sockets at the back of the unit and check that they correspond to those specified below Figure 4 5 Omnisense 8000S main unit rear view Table 4 4 Omnisense 8000 Rear Panel Sockets and Ports 1 Probe connections 2 Power switch 3 Power socket 4 Contrast and brightness adj
38. User may not separate its component parts for use as more than one system or for any other purpose Protection of Intellectual Property a The Product is protected under national and international copyright trademark and trade secrecy law The Product or components thereof may be protected under national and international patent laws All right title and interest to the Software shall remain with the Distributor and its supplier and or licensor The License granted herein does not constitute a sale of the Software or any portion or copy of it A copy of the Software is provided to the End User only to allow the End User to exercise its rights under the License The Hardware component of the Product is purchased by and the Soft ware is licensed to the End User for the End User s internal use and the Product may not be used by sub licensed re sold rented or distributed to any other party The End User may not assign the End User s rights under this Agreement without the prior written con sent of the Distributor b The End User acknowledges that the source code of the Software and the concepts and ideas incorporated by this Product are valu able intellectual property of the Distributor s supplier and or licen sor The End User agrees not to copy the Product nor to distribute any such concepts or ideas to any third party or to attempt or per mit others to decipher reverse translate de compile disassemble or create deriv
39. a multi site measurement report Referring Physician BOF as ese sis Risk Index ORI 20 25 30 35 40 45 50 55 60 65 70 75 80 85 Number of standard deviations from the Agelyears mean of age matched population Comments and Findings Comments Anamnesis O Normal O Osteopenia O Osteoporosis D Sunlight Medical Ltd Omnisense 8000S User Guide 9 15 CHAPTER 9 Interpreting the Results of a Measurement 9 4 Measurement History Omnisense includes a facility for reviewing the measurement history of a given patient providing a convenient method for assessing changes over time Measurement To open the Measurement History screen click on the Mea History surement History icon found on the toolbar Each measurement result is displayed in a separate row If the list is long use the a scroll bar to navigate up and down through the data A patient akele file must be open to access that patient s measurement history The Measurement History Screen The Measurement History screen is similar to the Result screen Figure 9 13 illustrates the History screen Figure 9 13 Measurement history screen Patient gt Show History or Toolbar gt History A Patient Administration Research Help Measu Patient Information Measurement History Patient ID 2277671 i Family Name king 3 0 4 r 4463 First Name Karol i Previous value fo 20 4 Curren
40. active only when the probe is applied Before the first cycle the button is labeled Start Before all subsequent cycles it is labeled Next Cycle Within the cycle the button is labeled Restart Clicking on the button during a cycle restarts the cycle deleting all acquired SOS values for that cycle Other cycles which have been completed remain intact NOTE The action of the foot pedal is equivalent to clicking this button and is recommended It allows your hands free dom to hold the probe continuously at the measurement site without interrup tion CHAPTER 8 probe cap 8 5 Patient SOS Measurement Button Function Abort Clicking on this button displays a dialog window with three options Abort Cancels the last measurement cycle Elapsed time is reset to zero and the cycle counter is reduced by one You can start the cycle again with Next Cycle or Start if you aborted the first cycle Abort all Cancels the current series of mea surement cycles The cycle counter is reset to zero Cancel Cancels the Abort You are returned to the measurement screen as you were If a cycle was in progress you can re apply the probe and continue Measuring SOS at the Radius If the probe is momentarily mispositioned on the site the audible tone will stop and the on screen indicators may turn red Some patients interpret this as a negative indication of bone status and may become alarmed Explain to the pat
41. after the scheduled appointment Note Upon performing a new measure ment a new Due Date is set and the Reminder is re set accordingly The License form is the fourth tab and is used for the introduc tion of your clinic s name address phone number fax number and e mail address see Figure 10 8 This information will be printed automatically on all SOS measurement result reports forms and other output printed by Omnisense Setting System Default Options Figure 10 8 System Options dialog box License screen Administration gt Options gt License A x Address p Phone Fax E mail C Apply Defaults Settings Scheduler License Distributor Clinic Add your logo to report OK or Cancel y In addition you may insert a logo for your clinic or hospital that will subsequently appear on all measurement reports printed by the device Prepare a file of the logo and place it on the root directory that is on the disk but not within a folder on the disk of a3 1 2 inch disk ZIP disk or CD disk depending on your preference and the type of Omnisense device you have The file should be a bmp file named logo bmp with a size of 200x200 pixels with 8 or 24 bits per pixel Insert the disk and click Add your logo to report at the bottom of the box seen in Figure 10 8 System Options dialog box License screen page 10 15 The device will remind you of the requirements listed above C
42. are given in Table 10 2 Table 10 2 System Options Defaults form Screen Item Local Area Function The four items in this section of the Options screen Country city and their codes will appear as default information on every new patient form 7 1 Patient Files page 7 1 If only part of the infor mation is specified here that part will appear as default and the remainder will display with blank fields This feature avoids the need to re enter information for each patient in cases where most of the patient population lives in the same area The two Code items at right from top to bottom are the telephone country code and area code respectively You may switch to other values for any individual patient Reference Database This setting determines which reference data will be used as a default when inter preting SOS values As above you may switch to another reference database for any individual patient Metrics Select your choice of preferred units for patient weight and height The units set here will appear whenever patient informa tion is displayed To be set during system installation User Guide 10 7 CHAPTER 10 System Administration Screen Item Function Time unit Changes the time interval for reference Month database information from years to months Used primarily in research set tings when measurement on animals are conducted Ask before This option appli
43. been available until now A system that grows To add an additional application or measurement site to the Omnisense capability one simply installs a software upgrade and in some cases additional hardware The base system remains unchanged 3 6 Sunlight Omnisense 7000S 8000S 4 1 Examination Room Environment Initial Setup This chapter guides you through your first use of Omnisense beginning with unpacking the system connecting cables power up and first time login to the software system Examination Room Environment A few basic guidelines should be followed when choosing the room in which SOS measurement will be conducted with Omnisense e An examination room in which extreme temperatures are avoided is recommended even when the unit is not in use In particular System Quality Verification cannot be con ducted when the phantom temperature is outside the range of 15 30 degrees Centigrade If for example the examina tion room temperature was below this range during the night a wait period will be required while the phantom sta bilizes to room temperature e Omnisense should be positioned so that direct sunlight is avoided If the phantom is exposed to direct sunlight it may be permanently damaged Do not position the unit near a heat source or air conditioner e The examination room should have a standard electrical outlet a stationary chair for the patient and a table or desk top on which the patient may
44. can celed by using these keys Editing Text in a Text Box or Window Table 18 5 Text editing Function Keys Delete the character to the BACKSPACE or DEL left or right or delete selected text Copy selected text onto the CTRL C or CTRL INS clipboard 18 4 Sunlight Omnisense 7000S 8000S 15 6 Moving Around Function Paste text from the clipboard Undo the last editing action Moving Around Keys CTRL V or SHIFT INS CTRL Z or ALT BACK SPACE Table 18 6 Moving between list amp dialog box items fields Function Between menu commands characters in a text box or items in a list Keys An ARROW key To the next or previous dia log box item amp to the next or previous field on the Main Screen Changing selection in field Main Screen fields TAB or SHIFT TAB Up amp Down ARROW keys To a dialog box item Right or left one word in a text box ALT the character underlined in the item name CTRL an ARROW key To the beginning or end of a line list or screen HOME or END User Guide 18 5 CHAPTER 18 Keyboard Shortcuts Function Keys Between tabs in the same Right amp Left ARROW dialog box keys 18 6 Sunlight Omnisense 7000S 8000S Moving Around User Guide 18 7
45. comfortably rest an arm or hand The Omnisense operator should be seated on a chair which can be easily moved around such as an exam stool User Guide 4 1 CHAPTER 4 Q 4 4 2 1 Initial Setup Please ensure that the wall outlet to be used for Omnisense is equipped with a proper grounding connection and complies with the IEC 601 1 and local country standards requirements Please ensure that the main unit power cable plug is of the appropriate type for the wall outlet Unpacking Omnisense Immediately upon receipt of Omnisense check the Shock Watch indicator located on the side panel of the box If the indicator is RED please note this condition on the bill of lading and call a Sunlight representative Unpacking Omnisense 7000S Ensure that all components indicated on your packing list were received In some cases the items supplied may vary with your order type These are indicated Be sure to check your shipping order for special items or specifications e Omnisense main unit and power supply cable Figure 4 1 Omnisense 7000S main unit front view page 4 5 e Flat color display monitor LCD with an isolation trans former e Keyboard and mouse e Probes as per your order e Foot pedal with connecting cable e One System Quality Verification Phantom e Accessories per skeletal sites ordered e Starter kit 4 2 Sunlight Omnisense 7000S 8000S 4 2 2 Unpacking Omnisense e User Guide
46. correct execution of the scan Repeat the entire procedure of the measurement cycle three times or until the Result button becomes active For informa tion on repeating a cycle see Measurement cycle start end but tons page 8 13 15 6 Sunlight Omnisense 7000S 8000S 15 2 15 3 Distal 1 3 Radius Distal 1 3 Radius A description of the methodology for locating the measurement site at the radius and measurement at the radius can be found in 8 3 Locating the Measurement Site page 8 6 and a descrip tion of the measurement methodology for measurement at the radius can be found in 8 5 Measuring SOS at the Radius page 8 16 Mid shaft Tibia Always measure the patient s non dominant side In case of a disorder or impairment in the non dominant limb such as an edema or mass use the contra lateral side instead Positioning the patient 1 The patient is seated in a chair The leg should be bent 90 degrees at the knee The leg may be bent slightly more than this amount but not less the leg should not be stretched for ward The patient s heel should be placed firmly on the floor Determining the area to be scanned 2 The length of the leg is measured starting from the plantar surface of the heel and ending at the tip of the knee knee height The measurement should be conducted using the gauge supplied with the skeletal site kit Figure 15 8 illus trates the gauge to be used User Guide 15 7 CHAPT
47. database with Omnisense you first collect your data and compile the results so that you have a sin gle reference SOS value for each age range gender and popula tion type of interest You then enter this data using the Reference DB Builder dialog box as described below User Guide 17 9 CHAPTER 17 Research Mode Figure 17 4 Reference Database Builder dialog box Research gt Reference DB A i Reference DB Builder x Site METATARSAL V PROXIMAL PHALANX III i Reference DB American z g 4100 4000 D Options Q iian l I Age in month 38004 37004 3600 Norm sD 20 36 52 68 84 E 4079 foz Age years EAEE V System Normative Database Cancel or Edit A Enter information in the fields on the screen as described in Table 17 4 Table 17 4 Reference Database Builder fields Screen feature Function Site Select the site for which the reference data were obtained Gender Enter the sex of the population from which the reference data were obtained Refe Enter a characterization of the population rence DB from which the reference data were obtained 17 10 Sunlight Omnisense 7000S 8000S Working with Reference Databases Screen feature Function SOS type Indicates if the SOS values recorded were maximum minimum or averaged over the sample SOS points acquired as specified in the site definition SOS type page 17 6 Options Check h
48. details on the different privileges of the different user types see Chapter 10 System Administration page 10 1 Adding users is accomplished with the User List screen found under the Administration menu as illustrated below User Guide 4 23 CHAPTER 4 Initial Setup Figure 4 15 Adding users with the User List screen Administration gt List of Users A User List x Physician Name Operator Name Add Amenda Add mal oe z y L Smith O Jery M Rose O Smith Remove Remove apply Associate onn Current user sunlight Change password OK or Cancel v In the screen above the user has entered the system with the highest level of access System Administrator You can add physician level user IDs by clicking on the Add button for the left window Similarly to add operator level user IDs click on the Add button at the right window Use the Remove button if you change your mind and wish to delete a user ID Note that this procedure only creates a new user ID that is known to the system it does not assign passwords to those users Passwords may be set or changed for any user ID only by the users themselves Initially a new user does not need a pass word to enter the system as described below 4 10 The Sunlight Desktop The Sunlight Desktop includes utilities for changing various settings on your device Any changes in Date Time Mouse Settings Regional Settings and K
49. e the palmar side is to the desk surface The fingers should be relaxed and not stretched or rigid Measuring SOS at the Phalanx 5 Select the CS probe for measuring at the proximal phalanx Ill 6 Disinfect the probe attach probe cap Probes should be disinfected before each patient use Disinfection must be done with specially pre moist ened towelettes not by immersion of any kind See Chapter 11 Cleaning and Disinfecting Omnisense page 11 1 for disinfection towelettes that have been approved for use with Omnisense Follow the instructions provided by the manufac turer of the towelettes If a probe cap is used the following procedure should be performed User Guide 15 3 CHAPTER 15 Correct position of the proximal phalanx for scanning is maintained by the operator s grasp Site Measurement Methodologies 1 Apply ultrasound gel to the probe surface 2 Mount the probe cap and make sure the cap s front skin is in good contact with the ultrasound gel and no air bubbles show 3 Another layer of ultrasound gel should be placed over the probe cap 7 Apply a uniform layer of ultrasound gel to the CS probe and on the entire dorsal surface of the proximal phalanx of the third finger Figure 15 4 Applying ultrasound gel to the scan area 8 Use your non dominant hand to grasp the third finger by the distal and medial parts and raise it slightly from the desk sur face Ensure that the pat
50. hd M Default user account settings gt Appliellisettngs to the current user account and tothe derault user profile Cancel Apply Choose the appropriate default font and click OK You will now return to the Language and Regional Dialog box Click OK in this box to change the settings as requested Clicking on the OK button after any selection will cause the system to reboot and restart automatically Clicking on Cancel will close the window without changing the current settings User Guide 10 19 CHAPTER 10 10 4 System Administration Patient Management The main function of this dialog window is to establish security for patients of individual physicians using Omnisense In general the Omnisense software automatically associates patient information entered by a user with that user s ID and user level If the user is at physician level patient information may be secured against access by other users Information relat ing to secured patients will be accessible only to the administer ing physician as well as any operators that have been associated with that physician For more information on setting secure sta tus for a patient in the Patient Information Form see 7 1 Patient Files page 7 1 For information on different levels of user status see 10 1 User Access Levels page 10 1 Security status set in the Patient Information Form relates only to the specific patient displayed
51. history of SOS measurements performed to verify system quality If a probe or phantom needs servicing or replacement you may be asked to provide this information If Omnisense is being used for research information on the ultrasound speed being detected by probes may be useful Probe Quality History is opened in the same way as the SOS measurement history for any patient Simply set Measurement Type to System Quality Verification and then select Show History from the toolbar or from the Patient menu The Probe Quality History screen is illustrated in Figure 10 15 The results of individual SOS measurements on the probe selected are listed at the left with the most recent measurement highlighted all measurements performed for the currently selected probe are plotted on the graph at right To see the his tory for another probe simply switch to a different probe in the Slot selection window above the graph 10 22 Sunlight Omnisense 7000S 8000S Probe Quality History Figure 10 15 Probe Quality History Patient gt Show History or Toolbar gt History A Sunlight Omnisense Adults Patient Measure Administration Research Help Ee to Measurement Type DE System Quality Verification Slot E 1 CM M Patient Information Probe Quality History Graph Patient ID m Family Name H First Name Probe Quality Data r Probe quality measurements E9 Date sos Norm Di ponams pran s7 a8
52. may take as much as an hour to stabilize at room temperature For this reason SQV is specified as required once daily but need not precede all SOS measurements of the day About System Quality Verification System Quality Verification SQV checks if the system and the probes are working properly by examining the signals returned when the phantom is used as a substitute for bone The phantom is illustrated in Figure 6 1 The phantom is made from a stable material such as Perspex through which ultrasound signals propagate at known speeds Figure 6 1 Phantom User Guide 6 1 CHAPTER 6 amp 6 2 System Quality Verification Never expose the phantom to direct sunlight for any length of time The sun s ultraviolet rays can permanently alter the characteristics of the phantom material rendering it unfit for verifying system quality Do not immerse the phantom in liquids To clean the phantom use a dry soft tissue or pre moistened towels or wipes followed by dry wipes to remove moisture Performing System Quality Verification If you proceed with SOS measurements without an SQV the system will display a warning that no verification has been con ducted today and suggests that you do so As indicated earlier you may defer the SQV provided that it is executed at least once daily However it is recommended that the SQV proce dure be completed as early as possible Otherwise the system warning will be displaye
53. monitoring time interval between successive regular check ups The Response Rate is the annual change in the early menopausal years Trend Assessment Margin and Least Signifi cant Change are 1 8 and 2 8 times the Precision error respec tively Trend assessment Interval and Monitoring Time Interval are the TAM and LSC divided by the Response Rate respec tively 2 14 Sunlight Omnisense 7000S 8000S 27 3 Clinical Studies Table 2 6 Description of the time intervals for repeated measurement for each of the skeletal site Skeletal Response Precision Change Follow up times Site Rate Error Criteria years TAM LSC TAI MTI Radius 0 39 0 40 0 72 1 12 1 8 2 9 Phalanx 0 89 0 81 1 46 2 27 1 6 2 6 Metatarsal 0 92 0 66 1 19 1 85 1 3 2 0 Tibia 0 34 0 45 0 81 1 26 2 4 3 7 TAM Trend Assessment Margin LSC Least Significant Change TAI Trend Assessment Interval MTI Monitoring Time Interval As can be seen from the table trends within the early post menopausal years could be assessed in less than two years at any skeletal site except for the less sensitive site i e Tibia More than two years are needed in order to establish the change with a higher statistical significance However bone changes which are caused by positive or negative intervention could generate if effective larger response rates compared to the nor mal average population changes detailed in
54. of a disorder or impairment in the non dominant limb such as edema a mass undetachable ring or IV line use the contra lateral side instead Seat the patient in a chair opposite the operator and close to a standard desk Sunlight Omnisense 7000S 8000S 8 6 8 7 User Guide Locating the Measurement Site STEP 2 Identify the Region to be measured The term measurement in this and the next step refers to the use of a gauge to find and mark the halfway point on the limb where an ultrasound scan will be applied This is not to be confused with SOS Measurement which is the main function of Omnisense Use the gauge supplied with the site kit to measure the Radius In general when the method for a site requires mea suring the limb to locate the exact scan area the start and end points to be measured are not always the anatomical range of the bone In the case of the Distal 1 3 Radius measure from the gauge platform to the tip of the middle finger as illustrated in Fig ure 8 3 Place the gauge on the desktop and set the patient s non dominant elbow on a table with the forearm vertical and the palm open and extended vertically All parts of the arm distal to the elbow should be aligned as straight as possible but without notice able muscular tension The examiner should verify that the arm is not slanted and that the platform is firmly seated on the desk surface Insure that the patient s fingers are not bent
55. of the limb The probe should be held so that the short dimension of its surface is tangent to the bone while its long dimension is parallel to the bone axis e Hold the probe with both hands as described Do not hold the probe with only one hand e Do not use a circular motion The probe movement should follow perpendicular to the marked line e Probe movement should extend at least 3 centimeters but not more than 4 centimeters from the crest User Guide 15 11 CHAPTER 15 15 4 Site Measurement Methodologies Do not continue the scan laterally from the crest Check to insure that a scan movement to the crest and back takes about 5 6 seconds The scan is being conducted too slowly or too quickly if the movement takes longer or shorter respectively than this amount of time Maintain the probe s surface in contact with the patient s skin throughout the scan No part of the probe surface should be raised from the skin at any point during the scan Do not press hard Additional pressure does not contribute any improvement in acoustic contact During the measurement cycle concentrate on the site and correct application of the probe Avoid looking at the screen Use the audible signal to provide feedback and guide you in correct execution of the cycle Repeat the entire procedure of the measurement cycle three times or until the Result button becomes active For informa tion on repeating a cycle see Measuremen
56. on the Sun light Desktop unless changed in the individual application User Guide 11 9 CHAPTER 11 The Sunlight Desktop Disk Utilities The Sunlight Desktop provides two disk utilities to simplify your work with the Sunlight device e To eject a CD RW disk from the device click Tools gt Eject e To format a3 1 2 inch or CD RW disk click Tools gt Format and follow the instructions on the screen 11 10 Sunlight Omnisense 7000S 8000S ol adr Cleaning and Disinfecting 12 1 Omnisense Cleaning and Disinfection General Instructions The Omnisense probe should not be used on subjects with breached skin or open sores on the skin area that comes into contact with the probe The Omnisense probe requires proper cleaning and disinfecting between each patient use Doing so may help prevent any potential transmission of infection between patients When probe caps are used disinfection is not required Protective gloves are recommended for cleaning and disinfect ing procedures Soiled materials should be disposed of in appropriate waste receptacles The Omnisense Device 7000S and 8000S CLEANING Cleaning should be done with the probes connected to make sure that no liquid gets into the probe sockets No disinfection is required for the Omnisense main unit since there are no patient contact surfaces User Guide 12 1 CHAPTER 12 Cleaning and Disinfecting Omnisense The following steps shoul
57. paper you will be using Two sizes are supported international A4 29 7 x 21 cm and US letter 8 5 x 11 inches Orientation This option should be set to Portrait To add a new printer driver to the device please see Printers page 11 9 Consult your system administrator to set up the addi tion of a network printer Disk Utilities Three facilities are provided for handling disk media Scan Disk Disk Compress and Format Diskette Scan Disk This facility checks the integrity of files on your disk drive and optionally checks the physical surface of the drive for defects The procedure can automatically repair file problems and in case of bad sectors will map the disk directory so as to avoid using them Although corrupted data on hard disks is rare it does happen and regular application of Scan Disk will lower the probability of data loss To run Scan Disk click Administration gt Repair Tools gt Scan User Guide 16 15 CHAPTER 16 Utilities and Peripherals Disk The following dialog box is displayed Figure 16 7 Scan Disk dialog box Administration gt Repair Tools gt Scan Disk A ScanDisk C R Options Start or Close vy Enter information in the dialog box fields as described in the table below When you are done click Start to begin the Scan Table 16 5 Scan Disk dialog box fields Select Drive Choose which drive is to be scanned Scan disk may also be used t
58. pre moist ened towelettes not by immersion of any kind See Chapter 11 Cleaning and Disinfecting Omnisense page 11 1 for disinfection towelettes that have been approved for use with Omnisense Follow the instructions provided by the manufac turer of the towelettes If a probe cap is used the following procedure should be performed 1 Apply ultrasound gel to the probe surface 2 Mount the probe cap and make sure the cap s front skin is in good contact with the ultrasound gel and no air bubbles show 3 Another layer of ultrasound gel should be placed over the probe cap User Guide 15 15 CHAPTER 15 Site Measurement Methodologies 8 Refer to the sequence of photos in Figure 15 17 Apply a uniform layer of ultrasound gel to the CR probe and on the area to be scanned The area to be scanned is a rectangular region whose length follows the long mark and whose width extends one to two centimeters in the dorsal direction 9 Place the probe parallel to the bone the probe s long axis is aligned and centered with the long mark and its short edge is parallel to and proximal along the short mark The short end that is marked with a small T should be closer to the short skin mark 10 Hold the probe with one hand Use the thumb and fingers 2 3 to grasp the probe around the two narrow sides of its neck and near its base fingers 4 5 palpate the bone during the scan to stabilize the hand Apply a slight pressure wi
59. price to the customer provided that the customer has returned the Product to the Company Any transport costs will be paid by the customer Any Product so replaced or repaired shall be subject to this war ranty for the remaining of the warranty period or 30 days which ever is later This warranty is valid in any country in which the Company s Products are distributed by the Company or its authorized distrib utor vi B Duration and Commencement of Warranty Period 1 The warranty period for each Product is one year The warranty period begins on the date the Product was purchased provided that the Company receives this warranty card within 30 days of purchase C Limitation of Warranty 1 The Company does not warrant that the operation of Products will be uninterrupted or error free The foregoing warranty applies only to defects resulting from normal use of the Products within the country in which it was pur chased and does not apply to defects resulting from Improper or inadequate maintenance Use of any parts or software not supplied by the Company Unauthorized modification or misuse of the Product Operation outside the range of the environmental specifications of the Product Improper site preparation or maintenance Accidental damage whether in transit or otherwise Except as provided for in this warranty neither the Company nor any of its suppliers makes any other warranties whether express or im
60. probe type to be used for this site type Gates For Sunlight research use only User Guide 17 5 CHAPTER 17 Research Mode Screen feature SOS type Function Minimum Maximum or Average specifies the value which will be recorded as the result of a measurement cycle at this site The three types are defined as follows Minimum is the 25th percentile of all SOS values obtained during the cycle Average is an average taken over all SOS values obtained during the cycle Maximum is the 95th percentile of all SOS values obtained during the cycle Omnisense waits for the results of at least three measurement cycles and allows as many as five It computes a final result as the average of three cycles have been found suffi ciently consistent See 8 4 Understanding the Omnisense Measurement Screen page 8 9 for more information Min Max SOS Specifies the maximum range of variation per mitted for the SOS signal at this site Outside this range SOS will not be recorded and the Acoustic Signal Acquisition indicator will show failure to acquire Number of points The number of sample SOS points which will be taken per measurement cycle The number of points can be seen on the graph which builds during a cycle the number of units on the horizontal axis corresponds to the value specified here 17 6 Sunlight Omnisense 7000S 8000S Working with User Sites Screen feature Functio
61. refer to Figure 4 2 Omnisense 7000S main unit rear view page 4 6 e Insert one end of the color display monitor data cable connector into the monitor socket on the rear panel of the main unit 11 Monitor data socket in Figure 4 2 Omnisense 7000S main unit rear view page 4 6 and insert the other end into the monitor e Insert one end of the color display monitor power cable connector into the monitor power socket on the rear panel of the main unit 8 Power outlet for LCD monitor in Figure 4 2 4 12 Sunlight Omnisense 7000S 8000S Cable Connections Omnisense 7000S main unit rear view page 4 6 and insert the other end into the mon itor The monitor receives electricity through the main unit and does not need to be con nected separately to a source of electricity Insert the keyboard connector into the key board socket 5 Keyboard socket in Figure 4 2 Omnisense 7000S main unit rear view page 4 6 and the mouse connector into the mouse socket 6 Mouse socket in Figure 4 2 Omnisense 7000S main unit rear view page 4 6 In case a keyboard with inte grated track ball is used the keyboard connec tor is the one with two cables connected to it the trackball connector has only one and should be connected to the mouse socket Each con nector cable has the corresponding labeling If you are installing a printer to be used with Omnisense insert the printer connector into the pri
62. results for all skeletal sites The fracture odds ratio for the Radius unadjusted for age is 1 72 95 CI 1 29 2 30 and the age adjusted odds ratio is 1 43 95 CI 1 04 1 93 The largest OR was found for the Metatarsal At the Radius for every 174 m sec decrease in SOS the odds of fracture increase by about 50 and for every decrease of 297 m sec in SOS the odds of fracture double Data for the other skeletal sites is presented in Table 2 4 2 10 Sunlight Omnisense 7000S 8000S 2 7 4 Clinical Studies Table 2 4 Logistic regression for predicting Any Osteoporotic Fracture AUC 95 Cl and OR 95 Cl OR AUC OR Age Adjusted Radius 0 63 1 72 1 43 0 56 0 70 1 29 2 30 1 04 1 93 Tibia 0 57 1 33 NS 0 50 0 64 1 00 1 76 Metatarsal 0 73 2 46 2 19 0 65 0 81 1 67 3 61 1 46 3 26 Phalanx 0 68 2 03 1 73 0 60 0 75 1 48 2 80 1 23 2 42 Conclusions This case control based study has shown that Omnisense at any skeletal site except for the Tibia can signifi cantly discriminate between subjects having any of the most common osteoporotic fractures and age matched non fracture controls This finding is noted despite a high likelihood that there are a significant number of osteoporotic subjects in the non fracture group The odds ratios found in this study for each of the skeletal site can be considered fracture risk estimates and are comparable to those of other bone assessment devices
63. sent a print job to a printer that is not functioning or not available with the device To clear the printer log of printing jobs that cannot be completed click Administration gt Repair Tools gt Printer Queue Choose the rele vant printer from the drop down list and click OK in the Printer Queue dialog box The printer log will then be cleared Print Screen To print an Omnisense screen for the use of technical support staff or for other reasons press Ctr and the PrtSc button at the top left of the keyboard at the same time In the dialog box that opens choose the media desired and click OK The screen will User Guide 16 21 CHAPTER 16 16 7 Utilities and Peripherals then be copied onto the disk in bmp form with the file name Screen bmp When the process is complete the device will inform you of this fact Click OK and eject the disk Logger This feature is a monitoring tool for maintenance purposes which saves to a file all operations up to 5000 carried out on Omnisense in the course of that day The logger starts anew every day when the system is operated for the first time When a system failure occurs the user gets a pop up message describing the possible failure e Ifthe failure is user maintainable the message instructs the user on the procedure required to overcome the failure e Ifthe failure is of a type that can be remedied by obtaining remote instructions by phone the message will advise the use
64. the cycle Once the cycle completes the measurement profile is displayed whether or not this option is checked The default option for this parameter is that the measurement profile is shown on the screen If you prefer to hide the mea surement profile graph during measure ment click the box to do so Measure Turns on or off the audible tone heard dur ment Sound ing a measurement cycle For normal clin ical work this feature should be active so that the examiner does not have to watch the screen for an indication of correct acoustic coupling Use of this feature allows the examiner to concentrate entirely on the scan site 10 10 Sunlight Omnisense 7000S 8000S Setting System Default Options Screen Item Function System This option determines the period of his Quality Veri torical SOS measurement data which will fication display with the SQV results screen System The four buttons in this area correspond to Setup standard Windows system settings The procedure for setting Date Time is given in 4 11 Setting the System Time page 4 25 The procedure for setting Language amp Regional is given in 10 3 User Interface Language Selection page 10 17 Key board allows you to select additional key board languages for data entry and Mouse enables control of mouse speed The next tab in the Options menu is called Scheduler and is illustrated in Figure 10 7 Figure 10 7 System Opt
65. to Part 15 of the FCC regulations These limits are designed to provide reason able protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accor dance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or televi sion reception which can be determined by turning the equip ment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver 14 6 Sunlight Omnisense 7000S 8000S Federal Communications Commission F C C Statement e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help User Guide 14 7 Site Measurement Methodologies 15 1 When conducting SOS measurements it is of the utmost impor tance that the procedures described be followed exactly Small variations in the manner of scanning may yield significantly different SOS values with the result that they can no longer be meaningfully scored against a reference database For additional help in m
66. to be imported First select the drive in which you have inserted the patient data information disk created with Export see next Click on the Read button The patient databases available are shown in the leftmost window indi 16 2 Sunlight Omnisense 7000S 8000S Import and Export of Patient Data cated by a serial number Choose a database and the list of patients it contains appears in the center win dow Select the patient data to be imported by clicking on those you want Repeated clicks accumulate more selections or unselect previous selections If you change your mind deselect all patient data with the Unselect All button Select all with the Select All button STEP 4 Execute the Import Click OK and the Import will proceed In case a patient ID in the data being imported is found identical to an ID in the current database Omnisense handles it in different ways depending on the Autoinsertion Mode setting as described in Table 16 1 A check box appears at the bottom of the Import Patient dialog box See Figure 16 1 Import dialog box page 16 2 If you have imported data from a CD RW diskette click on Eject in the Administration menu to eject the diskette User Guide 16 3 CHAPTER 16 gt 16 4 Sunlight Omnisense 7000S 8000S Utilities and Peripherals Table 16 1 Autoinsert policy for Import ae ee Import does this Import is With Autoinsert unchecked using data Import will stop at ever
67. 10 For users whose level does not permit them certain func tions e g Add or Associate those buttons are not active Current user ID and level shown here For the System Administrator only Current User is set to Sunlight System Administration Figure 10 1 Users List dialog box Administration gt List of Users A User List x Physician Name Operator Name Add Add Jerry pe O Amy mex Smith O Jery M Rose lt O Smith Remove Remove Diapply Associate Change password RS Current user sunlight OK or Cancel h Add users by clicking on the Add button at left to add a physi cian at right to add an operator The System Administrator and physicians can add both types of users operators can add only operators Clicking on Add causes the dialog box shown below to be dis played Figure 10 2 Add User dialog box Add New User Name x Add new user name Smith User IDs must be unique If the ID entered is the same as one which already exists in the system Omnisense will refuse to accept it as illustrated in Figure 10 3 10 2 Sunlight Omnisense 7000S 8000S User Access Levels Figure 10 3 Duplicate name warning 2 i il The name is already in the operator database Use another name Y OK When a new user has been added to the User List that user may subsequently enter the system for th
68. 14 1 14 3 Federal Communications Commission F C C Statement14 6 Site Measurement Methodologies 15 1 15 1 The Proximal Phalanx of the Third Finger 15 1 15 2 Distal 1 3 Radius 15 7 15 3 Mid shaft Tibia 2 15 7 15 4 Metatarsal V 0 0c ee ee 15 12 15 5 Practice Mode 200000es 15 18 Utilities and Peripherals 16 1 16 1 Import and Export of Patient Data 16 1 16 2 Data Conversion 000 cence eee 16 6 16 3 Backup Restore 00000es 16 9 16 4 Print SGtU Pi o 5 2 6 5 dis hie kcens eee so See ees 16 13 16 5 Disk Utilities 16 15 16 6 Other Utilities 16 21 16 7 Logger serina iea ett ete ee es 16 22 16 8 System Upgrade 5 16 23 17 Research Mode 17 1 17 1 The Research Mode screen 17 1 17 2 Working with User Sites 17 3 17 3 Working with Reference Databases 17 9 18 Keyboard Shortcuts 18 1 18 1 Howto Use Help 000 eee 18 1 18 2 Selecting Items in a Dialog Box 18 2 18 3 Using Menus 0 00 c eee eee eee 18 3 18 4 Using Dialog Boxes 055 18 4 18 5 Editing Text in a Text Box or Window 18 4 18 6 Moving Around XV xvi Figure 1 1 Figure 2 1 Figure 3 1 Figure 4 1 Figure 4 2 Figure 4 3 Figure 4 4 Figure 4 5 Figure 4 6 Figure 4 7 Figure 4 8 Figure 4 9 Figure 4 10 Figure 4 11 Fig
69. 16 1 Figure 16 2 Figure 16 3 Figure 16 4 Figure 16 5 Figure 16 6 Figure 16 7 Figure 16 8 Figure 16 9 Figure 16 10 Choose Drive window 0 0000 c cece cece 10 16 Logo OK window 0 0 cect tenes 10 16 System Options dialog box Distributor screen 10 17 Language and Regional settings 2 00005 10 18 Fonts dialo b0X scsi ods ge Gai nig se ae eas ee a ee Ra ees 10 19 Patient Management dialog box 0 2 2 eee eee 10 21 Probe Quality History 0 0 ccc ee ees 10 23 SQV choose probe window 0 0 0 0 0 cece eee eee 10 24 Site Order dialog box 0 kee ccc eens 10 25 License Status dialog box n nanna eee es 10 27 License Upgrade dialog box 0 0 cece eee 10 28 L gauge for measuring the phalanx 2 0 000 15 2 Correct position of gauge for measuring the phalanx 15 2 Marking the scan position 00 cece eee eee 15 3 Applying ultrasound gel to the scan area 2 0000 15 4 Grasping the patient s finger 0 2 0 cee ee eee ee eee 15 4 Correct position of the probe for scanning 15 5 The range of probe movement during the scan 15 5 Gauge used to measure the tibia 2 0 cece ee 15 8 Measuring the tibia 6 0 ee eects 15 8 Correct position of leg for measuring at the tibia 15 9 Scanning the tibia 2 2 eee eee 15 11 Initial patient position for
70. 5 2 Cable Connections for Omnisense 8000S Unit Setup Procedure STEP 1 Position the Omnisense Unit Place the Omnisense 8000S device on the surface where it will be operated Ensure that it is within reach of a standard electrical outlet and that it is well away from any source of heat or air condition ing Ensure also that there is room for patient and operator chairs near the unit and that sufficient desk or table space is available for a patient to rest an arm comfortably Unit Setup Procedure STEP 1 STEP 2 Position the Omnisense Unit Place the Omnisense 8000S device on the surface where it will be operated Ensure that it is within reach of a standard electrical outlet and that it is well away from any source of heat or air condi tioner Ensure also that there is room for patient and operator chairs near the unit and that sufficient desk or table space is available for a patient to rest an arm comfortably Attach Rear Panel Connector Cables Insert each component connector securely into the corresponding socket and tighten the screws if required refer to 4 5 on page 4 9 e Insert the keyboard mouse connector into the keyboard socket 7 Keyboard Mouse socket in the figure 4 16 Sunlight Omnisense 7000S 8000S Cable Connections e Ifyou are installing a printer to be used with Omnisense insert the printer connector into the printer socket 8 Printer output in the figure e Connect the foot pedal t
71. 8000 STEP 4 Electrical Power Connection e Ensure that the main unit power switch 2 Power switch in the rear panel 4 5 on page 4 9 is off Attach the Omnisense unit power cable to the appropriate socket on the rear panel 3 Power socket in 4 5 on page 4 9 Plug the other end of the cable into a standard electrical outlet e During normal use Omnisense is powered on with the rear panel power switch 2 Power switch in 4 5 on page 4 9 4 18 Sunlight Omnisense 7000S 8000S 4 6 4 7 Power On the System Power On the System Start the system by pressing the main power switch on the front panel of the main unit for 7000S and at the back of the device for 8000S The device will go through a short software initial ization procedure The Sunlight Desktop screen seen in Figure 4 11 Sunlight Desktop opening screen page 4 19 will appear Figure 4 11 Sunlight Desktop opening screen Start Options Tools Help op OMNISENSE Sunlight Ornnisense Adults Please note that the Sunlight Desktop contains icons for each of the applications available on the individual device The Sun light Omnisense Adults icon is used to enter the Omnisense Adults application the icon is seen in at the top left in the Sun light Desktop screen seen in Figure 4 11 Sunlight Desktop opening screen page 4 19 Initial System Access Click on the Sunlight Omnisense Adults icon on the Sunlight Desktop screen to open th
72. APTER 9 Interpreting the Results of a Measurement skeletal sites A key advantage of this feature is the improved accuracy of results which you can obtain from SOS measure ments The reason is straightforward if the result of a measure ment can be confirmed by measurements at additional sites your assessment is far less subject to error The Omnisense Multi Site capability is operated as follows The Measurement Type window includes a Multi Site option which is user selectable Selecting the Multi Site option will cause the right hand side list on the screen to change its name to ORI Osteoporosis Risk Index The list includes all possible pairs of measuring sites RAD 1 3 Distal Radius TIB Mid shaft Tibia MTR Metatarsal V and PLX Proximal Phalanx Ill Each pair has a small box to its left crossed in red if both sites were not measured on the same day or ticked in green if both sites were measured on the same day If only one site of a pair was measured on that day the box on the left of the pair will be ticked in yellow Measuring a second site on the same day will cause the box at the left of the pair denoting both sites measured to be ticked green If more than two sites three or four were measured on the same day all pair combinations of the sites measured will be ticked green or in yellow if only one site in the pair has been measured on that day Selecting a green ticked pair displays the Multi Site
73. C Full C Copy system files only r Other options Label pH I No label IV Display summary when finished I Copy system files Start or Close v User Guide 16 19 CHAPTER 16 Utilities and Peripherals Formatting a CD RW Disk Using Omnisense 1 Insert the CD RW disk into the CD RW drive Select For mat Diskette from the Administration menu Choose the appropriate drive from the drive options and click OK 2 A Direct CD format utility dialog box will be displayed In this dialog box fill out the following information Label If desired choose a label that will serve as a name for the CD RW up to 11 characters Format type Choose either the Quick Format or the Full Format option A new CD RW must always be formatted with the Full Format option Further formatting operations on the same disk may use the Quick Format option if desired 3 After filling out the above options click the Start Format button 4 Anew dialog box will now open with a message as follows Direct CD is about to format the CD in Drive E It will take approximately 25 45 minutes for processing proceed now 5 Click OK and the formatting process will begin A message box will indicate to you that the format is in progress When the format is complete another message box will inform you that the CD is ready Click OK and the CD will eject 6 The CD is now formatted and ready for use Formatting a Disk Using
74. Checking this option is equivalent to secur ing a patient in the Patient Management screen 10 4 Patient Management page 10 20 Operator Specifies the current operator the current user ID to administer SOS measurements for the patient Note that a physician can also be an operator so any current user ID sets this field This field is informational only and does not restrict other physicians and operators unless the Allow only physician to view option has been checked When so restricted an operator must be associated with the patient s physician to be allowed access OSTEOPOROSIS The second screen in the Patient Information form is the Osteoporosis tab The information in this tab relates to the fac tors that increase the risk of osteoporosis in the individual patient This risk factor information is not printed in the Omnisense measurement report you may add this information in the Comments Findings section of the report if you like Click on Osteoporosis to open this tab Enter the information as indicated User Guide 7 5 CHAPTER 7 Patient Files Figure 7 2 Patient Information dialog box Osteoporosis screen Patient gt New or Toolbar gt New Patient gt Additional A Patient Information OK or Cancel v Table 7 2 Patient Information form fields Osteoporosis General Height This item may be switched from Metric to Weight US UK units in the System Options screen as above
75. E Import EXPONE ter Gites Exit User Guide 7 17 CHAPTER 7 Patient Files Select a patient from the List of Patients screen and press the Delete button on its right If no patients are listed in the List of Patients database the Delete Patient function is disabled grayed out Figure 7 9 List of Patients with Delete button Patient gt List of Patients A List of Patients A xi Date of Birth yx 999 Smythe Samantha 01 02 1950 Female 09 07 2003 456 Stern Jeremy 01 09 1961 Male 09 10 2004 7899 Brown Lily 05 01 1945 Female 14 10 2004 Hina 9999 O Malley George 12 08 1939 Male 15 07 2003 p 13344 Sand Elaine 06 04 1955 Female 16 07 2003 2345 White Sandra 09 04 1957 Female Ed 66677 Lott Mervin 01 01 1949 Male Edit 444 Thompson Judy 01 01 1938 Female x Delete Find by Family Name ID 66677 Lott Mervin OK or Cancel Or Edit Or Delete v In both cases the dialog box with the warning message shown below appears requesting you to confirm or abort the operation accordingly Figure 7 10 Delete patient warning Are you sure you want to remove the current patient Patient gt Delete Patient A Yes or No h The dialog box has two buttons Yes and No and you are requested to confirm the deletion by pressing Yes or cancel the operation by pressing No 7 18 Sunlight Omnisense 7000S 8000S Tracking Down a Patient s Measurements 7 5 Tracking Down a Patients
76. ER 15 Site Measurement Methodologies Figure 15 8 Gauge used to measure the tibia suring the tibia also used in measuring the radius At left the gauge P Sunlight is closed at right extended for measure ment bao Sunlight gauge for mea F f c 7 3 3 The patient s foot holds the gauge platform firmly on the floor Measure to the tip of the knee knee height Find the exact halfway point to the distance measured and use a skin marker to draw a line on the dorso anterior surface of the leg perpendicular to the direction of the bone The line should be extended straight across the dorso anterior surface of the Tibia Figure 15 9 illustrates the measurement proce dure Figure 15 9 Measuring the tibia Use of the gauge to mea sure the tibia a x x 4 Raise the patient s leg and position the ankle on a leg rest The height of the leg rest should be the same as the height of the chair The patient s leg should rest comfortably if neces 15 8 Sunlight Omnisense 7000S 8000S Patient with limb to be scanned in leg rest Mid shaft Tibia sary the knee may be bent slightly to avoid discomfort from overstretching the leg Do not use the leg rest to support any part of the leg above the ankle Correct leg positioning is illustrated in Figure 15 10 Figure 15 10 Correct position of leg for measuring at the tibia Measuring SOS at the Tibia 5 Use the CM probe for me
77. Easti Reference Database and ORI Site 1 Site 2 was computed using the parameters of Table 2 7 W F Wrist Fracture H F Hip Fracture V F Vertebral Fracture RAD MTR PLX RAD PLX RAD MTR PLX MTR NF lt 2 5 46 16 35 41 32 20 NF gt 2 5 amp lt 1 0 33 47 46 44 47 62 NF gt 1 0 21 36 19 15 20 18 All F lt 2 5 53 39 61 60 60 54 All F gt 2 5 amp lt 1 0 37 49 34 36 33 43 All F gt 1 0 10 11 5 4 8 3 H F lt 2 5 59 43 68 67 63 61 H F gt 2 5 amp lt 1 0 32 48 28 28 32 36 H F gt 1 0 9 9 4 5 5 4 V F lt 2 5 48 44 60 57 68 56 V F gt 2 5 amp lt 1 0 43 44 36 41 28 44 V F gt 1 0 10 12 5 2 4 0 W F lt 2 5 55 27 48 65 55 41 W F gt 2 5 amp lt 1 0 35 59 45 35 32 55 W F gt 1 0 10 14 6 0 14 5 AUC All F 63 72 68 74 69 74 AUC H F 64 74 72 76 71 76 AUC V F 61 73 67 78 73 78 AUC W F 64 66 61 68 66 68 Results shown in Table 2 8 prove that the classification of the different groups in accordance to the WHO criteria was improved by introducing the ORI showing increase in both the sensitivity and specificity ofthe device Moreover the AUC computed for ORI RAD PLX as an example 0 74 is an improvement over the results for the individual sites 0 63 and 0 68 respectively 2 18 Sunlight
78. FT color LCD display Regulations IEC 60601 1 IEC 60601 1 2 Class B UL 2601 Part 15 of the FCC rules Class B Certifications 14 4 Sunlight Omnisense 7000S 8000S CE 0344 Mark UL Mark Technical Specifications Parameter Specification Specifications IEC 601 1 Class 1 Type B IPXO The UL classification for Omnisense is Class 1 Equipment Power 100 240VAC Autoswitchable Power Consump tion 50Hz to 60Hz Approx 80 VA including LCD dis play Operating envi ronment Temperature 10 to 35 C 50 95 F Humidity 30 to 75 non con densing Storage and Temperature 0 to 50 C transportation 32 122 F conditions Humidity 10 to 90 non con densing Dimensions Ww H D 37 5 cm x 28 5 cm x 13 6 cm 14 8 x 11 2 x 5 4 Weight Approximately 6 kg 13 Ib User Guide 14 5 CHAPTER 14 System Specifications Parameter Specification Printers Standard PC printers Recommended printer list appears on the Sunlight website at http www sunlightmedical com Interna tional html printers html Additional printers may be added with the Add Printer utility on the Sunlight Desktop see Printers on page 11 9 Backup Platforms CD RW drive approx 580 MB 3 5 drive 1 44 MB 14 3 Federal Communications Commission F C C Statement This equipment has been tested and found to comply with the limits for a class B digital device pursuant
79. HALANX III Site was not measured today 10 Perform the measurement of the second site as with the first one Once the measurement is completed and the second site results are displayed and reviewed pressing the right most button will display the Multi Site ORI result in the form of a graph and a table 11 Save the results by clicking on the Save Results button 12 At this stage you may choose to print the ORI results obtained An example of a Multi Site Report printout is shown in Figure 9 12 Please note that if you wish to calculate ORI results after measuring a patient at two sites with Single Site measurement this can be done Simply save and close the second single site measurement indicate Multi Site for the Measurement Type and ensure that the sites already measured appear in the ORI drop down box Click Measurement History to display ORI results Please note that Patient Risk Assessment calculation cannot be performed based on ORI results Sunlight suggests that you make use of the multi site measure ment feature Check the Sunlight web site User Guide 9 13 CHAPTER 9 Interpreting the Results of a Measurement www sunlightmedical com for up to date studies and clinical results on the significance of Multi Site measurement and rec ommended combinations or contact Sunlight directly 9 14 Sunlight Omnisense 7000S 8000S Multi Site Measurements Figure 9 12 Example of
80. How Supplied User Guide Power supply cable Gauges for marking the region of measurement according to the skeletal site order specification Measurement accessories according to the skeletal site order specification Starter Kit see below The Omnisense 8000S packaging includes the following Main Unit with self contained monitor Keyboard and Mouse Ultrasound probes according to order specification each probe contains a set of transducers some acting as trans mitters and the others acting as receivers housed tightly together in a compact holder Foot Pedal System Quality Verification Phantom User Guide and Desktop User Guide Power supply cable Gauges for marking the region of measurement according to the skeletal site order specification Measurement accessories according to the skeletal site order specification Starter Kit see below Also included as a Starter Kit for both types of devices 1 acoustic contact gel bottle 250 cc A Zip for 7000S or CD RW for 8000S diskette A 1 44MB diskette Skin Marker Screw Driver User Guide 2 25 CHAPTER 2 2 12 2 13 Essential Prescribing Information Operators Manual Refer to Chapters 2 through 18 for the complete directions for use and maintenance of the Omnisense Bone Sonometer References Kanis JA Melton LJ 3rd Christiansen C Johnston CC and Khaltaev N The Diagnosis of Osteoporosis J Bone Miner R
81. Measurements To view a list of all patients scheduled for the near future select the Scheduler button as illustrated in Figure 7 11 Figure 7 11 Selecting Scheduler report list Measurement Mode gt Single Site A Sunlight Omnisense Adults ve Administration Research Help Select amp Els Scheduler leasurement Type X Site X 1 DISTAL RADIUS Probe CM button Patient Information Measurement Patient ID i Cyce 1 of 5 Elapsed Time 0 12 First Name Date of Bit Gender E Height E Weight E BMI Visit Database list h After pressing the Scheduler button the Visit Database list illustrated in Figure 7 12 appears User Guide 7 19 CHAPTER 7 Patient Files Figure 7 12 Scheduler report list Main Screen gt Scheduler button A Red Icon E List of Patients filling PatientID FamilyName FirstName LestVisit_ Phone Address O Malley George 05 01 2002 0 Best Avenue 1 Anytown Unit 999 Smythe Samantha 05 01 2004 0 Main Street Everytown USA Post Due 2456 Stem Jeremy 05 01 2004 0 va Date period ee Brown Lily 05 01 2004 0 og 43344 Sand Elaine 05 01 2004 0 Third Street 33 Thistown Unit has passed 42345 White Sandra 05 01 2004 0 Village Street 34 Shropshire See exam _ 66677 Lott Mervin 05 01 2004 Q First St 1 New York United S ple page 4444 Thompson Judy 05 01 2004 Q Old Square 55 Shire United 10 6 4 Yellow Icon
82. OR LICENSOR BE LIABLE UNDER THIS AGREEMENT FOR ANY SPECIAL INCIDENTAL INDIRECT OR CONSE QUENTIAL DAMAGES WHATSOEVER INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF BUSI NESS PROFITS BUSINESS INTERRUPTION LOSS OF BUSINESS INFORMATION OR ANY OTHER PECUNIARY LOSS ARISING OUT OF THE USE OF OR INABILITY TO USE THE PRODUCT EVEN IF IT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES Because some states and jurisdictions do not allow the exclusion or limitation of liabil ity for consequential or incidental damages the above limitation may not apply to the End User Contents 1 Using this Guide 1 1 1 1 Outline of Contents 1 1 1 2 Conventions Used in this Guide 1 4 2 Essential Prescribing Information 2 1 2 141 Device Description 2 1 2 2 Intended Use Indications 2 2 2 3 Contraindications 05 2 3 2 4 WamingS ineen nae a a aa 2 3 2 5 Precautions 0 000 eee eee 2 4 2 6 Adverse Events 000200e eee 2 5 2 7 Clinical Studies 005 2 5 2 8 _Individualization of Treatment 2 20 2 9 Patient Counseling Information 2 23 2 10 Conformance to Standards 2 23 2 11 How Supplied 22200000 eee 2 24 2 12 Operators Manual 2 26 2 13 References nnanannannnnnnnnnno 2 26 3 Introducing Sunlight Omnisense 7000S 8000S 3 3 1 Quantitative Ultra
83. SPACEBAR box Change a patient s status to ALT S Secure Patient Manage ment List Change a patient s status to ALT U Unsecure Patient Man agement List Secure all patients on a list ALT A Patient Management List Choose a patient from Patient List 18 2 Sunlight Omnisense 7000S 8000S Type first characters of the family name and press SPACEBAR for selection 18 3 Using Menus Using Menus Table 18 3 Menu operations Function Activate the menu bar Keys ALT or F10 Disactivate the menu bar ESC or F10 if a menu is open press ESC twice Select a menu Choose a menu command ALT the underlined Character in the menu name An ARROW key ENTER or the under lined character in a command name Note Although you can choose any menu com mand by using this method many commands have faster keyboard equivalents which are usually shown next to the command on the menu User Guide 18 3 CHAPTER 18 18 4 18 5 Keyboard Shortcuts Using Dialog Boxes Table 18 4 Other operations of dialog boxes Function Keys Move between items See Moving around later in this chapter Carry out command Press ENTER Choose a selected item SPACEBAR Move around and select See Moving around items in a list and Selecting items later in this chapter Cancel the dialog box Press ESC or ALT F4 confirmation dialog boxes cannot be
84. Sunlight Omnisense 7000S 8000S Bone Sonometer User Guide Software Version 2 4 DUM 0048 Rev 01 C E cou Note The information in this document is confidential and proprietary It is provided to customers and authorized representatives of Sunlight Medical Ltd 2004 Sunlight Medical Ltd Sunlight Omnisense 7000S and Sunlight Omnisense 8000S are trademarks of Sun light Medical Ltd Other registered trademarks or trademarks are the property of their respective owners The Quality Management System of Sunlight Medical Ltd complies with the Quality Management Standards ISO 9001 EN 46001 MDD 93 42 EEC and FDA QSR requirements Sunlight Medical Ltd Via Altobelli 3a Imola Bologna 40026 Italy Fax 39 0542 642543 Tel 39 0542 642355 Contact Information Customer satisfaction is a Sunlight priority To help us in providing you with the best possible product and support please send us your comments and suggestions Contact us at the addresses and telephone numbers below US Sunlight Medical Inc 8055 Ritchie Highway Suite 103 Pasadena Maryland 21122 USA Tel 1 410 553 9293 Fax 1 410 553 9295 Toll Free 1 800 750 6011 e mail support sunlightnet com Europe Sunlight Medical Via Altobelli 3a Imola Bologna 40026 Italy Tel 39 0542 642355 e mail support sunlightnet com iii Asia Sunlight Medical Asia Shanghai Representative Office Room 1984 Building B 100 Zu
85. Sunlight Omnisense 7000S 8000S Shutting down New Ctrl N Open Ctrl O Edit Patient Ctrl E Delete Patient Close Ctrl C Show History Ctrl H Print Ctrl P Import Export Exit Ctrl x Changing Users and Shutdown STEP 3 Exit the System From the Patient menu choose Exit STEP 4 Choose type of exit The following dialog box is displayed Figure 5 1 Exit dialog box x Are you sure you want to C Shutdown C Reboot system C Enter with another user name Exitto Desktop Choose the option you want and click OK If you choose Shutdown the device will be closed When the message It is now safe to turn off your computer appears turn off the system using the main power switch The second choice will cause the software to restart reboot and ask for a user ID and password if not a first time user The third option dis plays the Please Login dialog box so that you can enter the sys tem with another user name The last option exits the Omnisense application and takes you to the Sunlight Desktop so that you can enter another application User Guide 5 13 System Quality Verification 6 1 System Quality Verification must be performed daily preferably before the first measurement of the day The phantom and the probe must be at room temperature when conducting System Quality Verification SQV If you start up Omnisense on a cold morning the phantom
86. Table 2 6 thus shortening the monitoring time intervals Multi Site Studies Osteoporosis Risk Index Background As osteoporosis is a systemic disease and discordance are often observed while measuring different skeletal sites a multi site parameter the Osteoporosis Risk Index ORI was formed to provide a risk assessment and diagnostic power equal or better than that provided by each of the single sites on an average basis The ORI is formed based on the assumption that skeletal sites User Guide 2 15 CHAPTER 2 Essential Prescribing Information do contribute according to their responsiveness to change and specifically responsiveness to SOS change with age The parameter formed based on the reference database was then tested using the cross sectional studies The ORI value for any combination of two sites is computed as a linear combination of the individual T score values of each of the sites using specific parameters ORI Site 1 Site 2 a T Site 1 ayT Site 2 The linear combination parameters a and a are given in Table 2 7 for each pair of sites These parameters were chosen so as to maximize the sensitivity for T score changes with age of the combined index where the higher sensitivity site contributes more than the lower one Table 2 7 ORI Site 1 Site 2 linear combination parameters RAD Distal 1 3 Radius TIB Mid Shaft Tibia MTR Metatarsal V PLX Proximal Pha
87. This data is used to calculate body weight for the Clinical Risk Factors in this screen 7 6 Sunlight Omnisense 7000S 8000S Patient Files Field Age at Meno pause Description Age of menopause in years Leave this field blank for premenopausal patients This data is used to determine the presence of early menopause for the Clinical Risk Factors in this screen Risk Factors Previous Osteoporo tic frac tures Clinical Risk Fac tors A series of checkboxes used to indicate pre vious osteoporotic fractures sustained by the patient A series of checkboxes for the physician to check if applicable including Low trauma fractures in first degree rela tives Early menopause this will be automatically checked by the device if the inputted meno pause age is under 45 Low body weight this will be automatically checked by the device if inputted weight is under 127 Ib 58 kg or if inputted height and weight yield a BMI score that is under 24 Loss of height from peak Tool tips which appear when the mouse passes over one of these checkboxes are provided to aid the physician in filling out this information User Guide 7 7 CHAPTER 7 Patient Files Field Description Lifestyle A series of checkboxes for the physician to habits check if applicable including Low calcium intake No or low physical activity High caffeine consumption Current cigarette smoking Tool tips which ap
88. able format on a second page To enable this option check the Print Full Table box in Administra tion gt Options gt Defaults Table 9 3 describes useful indicators on the History screen Table 9 3 History screen indicators Indicator Meaning Yellow high The highlight bar always appears in the light bar table of SOS measurement results at the lower left of the History screen When you enter the screen the most recent mea surement conducted for this patient is highlighted Blue dot Each individual measurement result is indicated on the graph by a blue dot User Guide 9 17 CHAPTER 9 Interpreting the Results of a Measurement Indicator Meaning Purple dot The result of a measurement performed on the date viewed is indicated by a purple dot When entering through the Measure ment History menu all dots are colored blue Use the Print icon on the toolbar to print a hard copy of the Measurement History for your use To set up your printer see Chapter 15 4 Print Setup page 15 14 Close patient button To exit the History screen click on the Close Patient button found to the right of the patient information area or select Patient gt Close from the menu bar 9 18 Sunlight Omnisense 7000S 8000S oN ewe System Administration 10 1 User Access Levels When you enter the system for the first time you have the sta tus of System Administrator The user ID is Sunlight and the password y
89. age 15 14 A copy of the measurement report appears in Figure 9 4 Example of a measurement report page 9 6 below User Guide 9 5 CHAPTER 9 Interpreting the Results of a Measurement Figure 9 4 Example of a measurement report Measurement Rep ort 09 1072003 Family Name First Name AQE Referring Physician Reporting Physician CIONI vanast srcsensss recesses avans saseee alae a DISTAL RADIUS DISTAL RADIUS Previous value Current value Fracture RISK 0c 10 ZHSCOLO cscessrssecsserssssenssesssones 1 8 Number of standard deviations from the 20 2 30 35 40 45 5 55 6 amp 70 75 80 BS of age matched moan of age population J Comments and Findings Comments Anamnesis Findings O Normal O Osteopenia O Osteoporosis Diagnosis Signature Device Details P Sunlight Medical Ltd Omnisense 8000S 9 6 Sunlight Omnisense 7000S 8000S Viewing Measurement Results Patient Risk Assessment In addition to T score and Z score results the Omnisense device also provides the physician with a Patient Risk Assess ment score which estimates the absolute risk that the patient will sustain an osteoporotic fracture over the next ten years in terms of percentage A score of 18 for example as seen in the screen shown in Figure 9 5 Patient risk assessment page 9 7 indicates that the patient has an 18 risk of sustain ing an osteoporotic fracture over the n
90. aintain You can override these settings for individ ual patients Only the system administrator or a physician may change the Options settings operators do not have access to the Options form To set System Options select Options from the Administration menu Administration gt Options The form displayed has five screens or tabs namely Defaults Settings Scheduler License and Distributor Figure 10 5 shows the Defaults screen Figure 10 5 System Options dialog box Defaults screen Administration gt Options gt Defaults A xi Defaults Settings Scheduler License Distributor Country United Kingdom Country Code faa 4 OK City Area Code Reference Database Hence Asian American x Metrics Hee ED priy kalem M Time unit Month I Print Full Table Obes T Physician only OK or Cancel h Enter the data in each field as indicated using the tab key or the mouse to move between fields All information entered here will appear automatically for each new patient as a default but may be changed by entering other data for individual patients The exception is Metrics which refers to the units in which patient weight and height will be shown on the Patient Form This can only be changed in the Options dialog box and should 10 6 Sunlight Omnisense 7000S 8000S Setting System Default Options be specified during system installation Further details on these fields
91. akenly clicked on the right arrow button after the last entry the OK button becomes greyed out Click on the left arrow button to return to the previous entry then click OK Check and edit data After you click OK the button changes to Edit Click on this button again if you wish to make any changes to the data entered To delete all Age Step Norm and SD information and start fresh click on the finger button When you are satisfied that all data are correct and you have saved by clicking OK click Cancel to exit Print the reference data If desired click on the Print button to produce a hard copy of the reference SOS graph User Guide 17 13 Keyboard Shortcuts If you prefer to work using the keyboard only without operat ing the mouse Omnisense permits the use of acceleration keys that help you complete all the necessary functions with the keyboard only 18 1 How to Use Help Table 18 1 Using Help Function Keys Start Help F1 Move between topics See Moving around section Move between tabs See Moving around section Move among the jumps in a ARROW keys topic Choose a subject and enter it ENTER or SPACE BAR Quit Help ALT F4 User Guide 18 1 CHAPTER 18 18 2 Keyboard Shortcuts Selecting Items in a Dialog Box Table 18 2 Dialog box selection incl Patient List and Patient Management list Function Description Select a list item or check
92. aking sure that you are conducting a measurement correctly take advantage of the Practice Mode and method videos built into the Omnisense device Choose a site from the Measurement Site drop down list and click on the Measurement Methodology button to view a video of the cor rect measurement method for that site Please note that in the event of any inconsistency between a video and the User Guide the User Guide should be considered authoritative The Practice Mode is accessed through the Help menu for fur ther explanations on this utility and its operating mode see Practice Mode on page 14 25 The Proximal Phalanx of the Third Finger Always measure the patient s non dominant side In case of a disorder or impairment in the non dominant limb such as edema a mass undetachable ring or IV line use the contra lateral side instead Positioning the patient 1 The patient should be seated comfortably opposite the oper ator and adjacent to a standard desk or table The arm and hand are placed on the desk close to the operator User Guide 15 1 CHAPTER 15 The L gauge has two sections the scale on the shorter leg of the gauge is fitted to the proximal phalanx the scale on the longer leg of the gauge applies to the medial phalanx The shorter part of the L gauge should hold to the proximal phalanx while the longer section is against the medial pha lanx Site Measurement Methodologies
93. al end of the metatar sal shaft The L gauge supplied with the metatarsal site kit is illus trated in Figure 15 15 Note that the same L gauge is used with the proximal phalanx Figure 15 15 L Gauge for use with metatarsal V Position the L gauge on the foot so that the inside corner is at the dot marked previously the long part is parallel to the bone extending to the lower part of the lateral malelus and the short part is parallel to the toes Mark two perpendicular lines coinciding with the inside shape of the L gauge the lines meet at the marked dot Ensure that the gauge is fixed to the malelus and that the gauge s internal corner remains aligned with the dot marked earlier The two lines drawn will be referred to as the long mark and the short mark Figure 15 16 illustrates the marking procedure 15 14 Sunlight Omnisense 7000S 8000S Metatarsal V Figure 15 16 Marking the scan region with the L gauge Draw two perpendicular lines inside the L gauge The distal prominence of the metatarsal V is the meeting point of the two lines Measuring SOS at the Metatarsal V 5 Adjust the patient s position so that the Achilles ligament is supported by the leg rest as close to the operator as possible 6 Use the CR probe for measuring at the metatarsal V 7 Disinfect the probe attach probe cap Probes should be disinfected before each patient use Disinfection must be done with specially
94. alues by age and gender for the different skeletal User Guide 2 5 CHAPTER 2 Essential Prescribing Information sites Databases were obtained for Caucasian women in the Middle East Caucasian women and men in North America and Asian women and men Methods Asian and Caucasian subjects between the ages of 20 and 90 years old were recruited from the general population Data were collected from multiple sites at different geographic locations in North America in the Middle East and in Far East Participating subjects had a negative history of osteoporotic fracture or chronic conditions affecting bone metabolism were not taking medications known to alter bone metabolism and none had experienced premature menopause Results Different reference databases were constructed from SOS measurements of the distal one third radius the mid shaft tibia the proximal phalanx III and the metatarsal V obtained from 500 1500 subjects depending on geographic location gender and skeletal site Peak bone SOS was noted at age 36 45 at the radius phalanx and metatarsal while at the Tibia peak SOS is reached at a lower age Reference curves for each of the gender and ethnic groups were constructed using a moving average method with a window of 5 years around each age point Table 2 1 presents an example of the radius mean SOS results by age decade for the different geographic locations and different genders Figure 2 1 depicts an example o
95. an GMT 04 00 Abu Dhabi Muscat GMT 04 00 Baku Tbilisi Yerevan GMT 04 30 Kabul L icmT 05 00 Ekaterinburg GMT 05 00 Islamabad Karachi Tashkent feel cT 05 30 Chennai Kolkata Mumbai New Delhi GMT 05 45 Kathmandu GMT 06 00 Almaty Novosibirsk GMT 06 00 Astana Dhaka GMT 06 00 Sti Jayawardenepura GMT 06 30 Rangoon GMT 07 00 Bangkok Hanoi Jakarta OK or Cancel h Setting System Default Options When installing the system at your clinic it is recommended to set all relevant system defaults that influence both everyday work and system printouts These include the default reference database to be used definitions of height and weight measure ment units clinic information language selection regional set tings and all other relevant parameters Please refer to Chapter 10 System Administration page 10 1 for a complete detailed description of all these functions New User Entry A new user enters the Omnisense system for the first time as described above 4 7 Initial System Access page 4 19 Add User Guide 4 27 CHAPTER 4 Initial Setup a new user name as described in 4 9 Adding Users page 4 23 The next time the new user enters the system follow the procedure below When the desired application is chosen on the Sunlight Desk top the Login dialog box appears as usual Figure 4 19 New user access to Omnisense Choose application from Desktop A Please Login E
96. and can be carried out by typical clinic personnel after instruction and hands on training With its high accuracy portability low cost and ease of use Omnisense is tailor made for the primary care clinic when used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and ultimately in the determination of fracture risk Relationship between Omnisense Results and Risk of Fracture Use of the Omnisense Bone Sonometer in the assessment of fracture risk is based firstly on the results of clinical studies designed specifically for Omnisense and secondly on known results for quantitative ultrasound methods in general Sunlight has conducted cross sectional clinical studies which have demonstrated that the Omnisense Bone Sonometer dis criminates effectively between subjects with osteoporotic frac tures and subjects without fracture Key statistical measures of the predictive ability of SOS the Odds Ratio and ROC area have been found generally higher than equivalent measures of the predictive ability of other bone assessment techniques 3 4 Sunlight Omnisense 7000S 8000S Relationship between Omnisense Results and Risk of Fracture including Dual X ray Absorptiometry DXA and heel bone sonometers Omnisense Innovations Omnisense introduces a number of innovations as regards the accuracy and significance of SOS r
97. asuring at the mid shaft tibia 6 Disinfect the probe attach probe cap Probes should be disinfected before each patient use Disinfection must be done with specially pre moist ened towelettes not by immersion of any kind See Chapter 11 Cleaning and Disinfecting Omnisense page 11 1 for disinfection towelettes that have been approved for use with Omnisense Follow the instructions provided by the manufac turer of the towelettes If a probe cap is used the following procedure should be performed 1 Apply ultrasound gel to the probe surface 2 Mount the probe cap and make sure the cap s front skin is in good contact with the ultrasound gel and no air bubbles show User Guide 15 9 CHAPTER 15 Site Measurement Methodologies 3 Another layer of ultrasound gel should be placed over the probe cap see step 7 Refer to the sequence of photos in Figure 15 11 Apply a uniform layer of ultrasound gel to the CM probe and on the area to be scanned The area to be scanned is a rectangular region which has the skin mark as a center line and width equal to the width of the probe The probe has markers at its center point on either side Position the probe so that the center markers are aligned with the skin mark on the patient s leg and the long dimen sion of the probe is parallel to the bone axis The short edge of the probe that is marked with a T at the bottom should be closer to the foot
98. atabase Conclusion These studies provide representative samples of women or men Caucasian or Asian for use as a reference pop ulation and for computing T scores and Z scores User Guide 2 7 CHAPTER 2 Dip Essential Prescribing Information Cross Sectional Study of Hip Fracture Risk Objective To determine the ability of Omnisense to discrimi nate osteoporotic hip fracture subjects from age matched non fracture subjects and young healthy subjects and to determine the fracture risk estimate Methods The study was carried out by one investigator at two investigational sites in the Middle East A total of 365 Cauca sian women were recruited into three groups Hip fracture sub jects were 65 to 85 years of age and were not taking medications having a positive effect on bone metabolism Eld erly non fracture subjects were age matched to hip fracture sub jects Young healthy subjects were 35 to 45 years of age Results Table 2 2 contains a summary of SOS results measured at the distal 1 3 radius in m sec for each study group All pair wise differences between the three groups were statistically sig nificant p lt 0 0001 Table 2 2 SOS Results by Study Group Radius Only Hip Fracture Non Fracture Young Healthy N 50 N 135 N 180 SOS Mean SD 3861 149 3966 145 4165 96 T Score lt 2 5 70 39 1 T Score gt 1 0 10 24 85 Logistic regression for hip fracture discriminatio
99. ate con sistency of SOS value also known as intra operator precision In other words you must execute each cycle in exactly the same way Although only three good cycles are required Omnisense gives you five cycles in case as many as two are inadequate When Omnisense has detected a total of three good cycles the Result button at the lower right becomes active allowing you to view the final result If you have fewer than three good cycles after five tries you will need to abort the current series and start again Sunlight Omnisense 7000S 8000S 8 10 8 11 User Guide Understanding the Omnisense Measurement Screen If the correct procedure is followed more than three cycles are rarely required To help you maintain correct procedure the Omnisense software provides you with continuous feedback during the measurement There are three feedback indicators on the screen the acoustic signal acquisition indicator the acoustic contact indicator and the progress bar and also an elapsed time indicator In addition to the screen indicators an audible tone is heard when both the acoustic contact and acous tic signal acquisition indicators are green To ensure correct SOS measurement procedure it is recommended that the examiner concentrate on the measurement Region of Interest ROI and not on the Omnisense screen An audible tone is emitted by Omnisense whenever both the acoustic contact and acoustic signal acquisition indica
100. ation associated with other traditional techniques such as radiography X ray absorptiometry and computed tomography Avoidance of unnecessary exposure to harmful radiation is especially impor tant in the primary care setting for which Omnisense was designed The physical basis of QUS Sound energy consists of alternating cycles of compression and User Guide 3 1 CHAPTER 3 3 2 Introducing Sunlight Omnisense 7000S 8000S relaxation rarefaction of the medium through which it is trans mitted Audible sound for humans is in the range of 20 Hz to 20 000 Hz 20 kHz Ultrasound refers to a range of frequencies that begin at the end of the audible range and extend into the Megahertz range The propagation of ultrasound through a medium its speed dispersion and attenuation of signal strength are strongly influ enced by the physical properties of that medium QUS takes advantages of these influences to draw conclusions about the physical properties of bone through which an ultrasound signal is traveling Two measures are in common use the attenuation change in amplitude of the signal and the speed of its trans mission through bone The latter measure commonly abbrevi ated SOS for Speed of Sound is the one used by Omnisense While based on the same principle as other QUS devices Omnisense is distinct in its unique Omnipath Axial Transmis sion i e measurement along the bone axis Omnisense Technology Omnipath
101. ative works based on the Product or any part thereof or to develop methods to enable unauthorized parties to use the Product or to develop any other product containing any of the con cepts and ideas contained in the Product Trademarks may be used only to identify printed output produced by the Product The provi sions of this paragraph shall survive the termination of this Agree ment c The Distributor and or its supplier and or licensor shall have the right but not the obligation to defend or settle at their discretion any legal action against the End User arising from a claim that the End User s permitted use of the Product under this Agreement infringes any patent copyright or other ownership rights of a third party The End User agrees to provide the Distributor written notice of any such claim within ten 10 days of the End User s notice thereof and provide reasonable assistance in its defense The Dis tributor and its supplier and or licensor have sole discretion and control over such defense and all negotiations for a settlement or compromise unless they decline to defend or settle in which case the End User is free to pursue any alternative the End User may have 4 No Warranty THE DISTRIBUTOR S SUPPLIER AND OR LICENSOR DOES NOT WARRANT ANY WARRANTY OF ANY KIND TO END USER No Liability for Consequential Damages TO THE MAXI MUM EXTENT PERMITTED BY APPLICABLE LAW IN NO EVENT SHALL THE DISTRIBUTOR S SUPPLIER AND
102. be inserted into either of the two left side sockets Press the connector firmly into its socket Tighten the locking screws as this ensures proper electrical ground Repeat this procedure for the second probe and tighten locking screws 4 14 Sunlight Omnisense 7000S 8000S Cable Connections STEP 4 Electrical Power Connection The following are normally done once during ini tial setup e Note carefully the power rating of your Omnisense unit 230 or 110 V autoswitchable and insure that you are using an electrical outlet with either rating e Ensure that the main unit power switch in the front panel Figure 4 1 Omnisense 7000S main unit front view page 4 5 is off e Attach the Omnisense unit power cable to the appropriate socket on the rear panel 9 AC power inlet in Figure 4 2 Omnisense 7000S main unit rear view page 4 6 Plug the other end of the cable into a standard electrical outlet Ensure that the wall outlet used for Omnisense is equipped with a proper grounding connection and complies with IEC 601 1 standards requirements e During normal use Omnisense is powered on with the front panel power switch Table 4 1 Omnisense 7000S Front Panel Indicators and Ports in Figure 4 2 Before attempting to connect or disconnect Omnisense from the main power ensure that the main unit power switch located on the front panel is off User Guide 4 15 CHAPTER 4 Initial Setup 4
103. be mounted over the probe measuring surface and another uniform layer of ultrasound gel should be applied The probe is positioned parallel to the bone axis and is held at the base The probe is moved around the cir cumference of the radius with its longest dimension approxi mately in parallel to the axis of the bone The measurement consists of three consistent measurement cycles each of which is comprised of several bone scans Results are expressed in meters per second m sec reflecting the upper 95th percentile of the sorted SOS values Omnisense reports the bone SOS together with the T score units of stan dard deviations relative to population reference values of healthy young adults Z score values units of standard devia tions relative to age and gender matched population reference values and patient risk assessment computed using the patient s SOS value and a reference database For any two mea sured skeletal sites Omnisense may report the Osteoporosis Risk Index ORI which combines the individual results into a single clinical index No calibration is required Daily system verification is accom plished using the System Quality Verification SQV phantom supplied with the device Intended Use Indications The Sunlight Omnisense 7000S 8000S Omnisense Ultra sound Bone Sonometer is a non invasive device that is designed for the quantitative measurement of the velocity of ultrasound waves Speed of Sound
104. be raised from the skin at any point during the scan e Do not press hard Additional pressure does not contribute any improvement in acoustic contact e During the measurement cycle concentrate on the site and correct application of the probe Avoid looking at the screen Use the audible signal to provide feedback and guide you in correct execution of the cycle Repeat the entire procedure of the measurement cycle three times or until the Result button becomes active For informa tion on repeating a cycle see Measurement cycle start end but tons page 8 13 User Guide 15 17 CHAPTER 15 15 5 Site Measurement Methodologies Practice Mode The purpose of this feature is to allow the user to practice the specified bone measurement methodology and receive feed back on his her performance and measurement precision The Practice Mode is accessed from the Help Menu Help gt Practice Mode When this feature is operated the S W header changes to Sunlight Omnisense Adults Practice Mode and remains so until the user exits this mode Figure 15 18 Accessing the practice mode Sunlight Omnisense Adults Patient Measure Administration Research Help Help Topics Fi Measurement Methodologies Measurement Type A System Quali MBAS When entering the Practice Mode a warning appears in the dia log box shown below You are prompted to confirm the opera tion by pressing Yes or a
105. ble 6 Press the Update License button Your license is now updated Figure 10 19 License Upgrade dialog box Administration gt License Status A License Upgrade form x 1 Verify Current License Type l Pay Per Scan g ool Exit 2 Verify how many Scans previously ordered 100 Used 10 3 Enter number of new Scans l 4 Enter Code ooo Jooo J o H 5 Check Mew iCEngEypE Not enough Data entered Updated Niriker ot acans M Restore 6 Press Updete licence Exit or Update License v The Restore button is used by Sunlight technical personnel after a system failure to rebuild current license status information It should not be used by Sunlight customers 10 28 Sunlight Omnisense 7000S 8000S The Sunlight Desktop 11 1 Sunlight Desktop is a stand alone application developed by Sunlight to enable the operation of multiple medical diagnostic applications from a single Omnisense device Installation New Omnisense Devices The Sunlight Desktop software is pre installed in all new Omnisense devices The device will initially start up with Sun light Desktop It is recommended that the user during his initial use of the device choose an application that will appear upon start up of the device The procedure is described in Default Start up Options page 11 5 Previously Installed Omnisense Devices On an Omnisense device that is currently in use to run a single Omnisense application ins
106. bort by pressing No Figure 15 19 Practice mode warning Information for User x e Practice Mode was chosen Results will not be saved 2 Continue vz When using the practice mode the application operates in the same manner as in the regular measurement mode described in Chapter 8 Patient SOS Measurement page 8 1 and Chapter 15 Site Measurement Methodologies page 15 1 except for the following differences 15 18 Sunlight Omnisense 7000S 8000S Practice Mode e After the user carries out the second measurement the application calculates and provides the Coefficient of Vari ance CV value and measurement results by means of a score according to a CV score precision score table see below From that point on following each new measure ment the application provides the recalculated CV score e The CV score is given per measurement site and the CV score is site dependent accordingly CV score is a function of the Standard Deviation and your aver age measurement values Your CV score should fall in the range stated in the column labeled Good in Table 15 1 CV scores page 15 19 for each skeletal site before you start mea suring patients Table 15 1 CV scores CV Scorel Site Good Needs Improvement Poor Distal 1 3 Radius lt 0 40 gt 0 40 lt 0 80 gt 0 80 Proximal Phalanx lt 0 81 gt 0 81 lt 1 62 gt 1 62 Ill Metatarsal V lt 0 66 gt 0 66 lt 1 32 gt 1
107. cense information from the Sunlight Desktop the Desktop provides a utility to do so 11 8 Sunlight Omnisense 7000S 8000S Desktop Utilities Updating Sunlight License Information STEP 1 Open License Update box Click Start gt Update Sunlight License Info The License Application Upgrade form dialog box will open STEP 2 Obtain new license code Contact Sunlight Customer Support to obtain a new license code that will change or update your license type STEP 3 Input information Input the new license code in the Enter code fields in the dialog box Press the Update License button at the bottom of the box and click OK The device will automatically reboot and will include the new information when it restarts Printers To add a printer to the device click Options gt Add Printer and follow the instructions on the screen Please ensure that you have the printer you wish to install and the printer driver usu ally supplied on a CD with the printer If the software requests a password please use the password MP5373 Any printer added by this procedure will be available to all applications on the Sunlight Desktop To set a default printer for the device click Options gt Default Printer Choose a printer from the list that appears in this win dow and set print options such as paper size and paper orienta tion Click OK to complete the procedure Please note that these print settings will apply to all applications installed
108. current patient s SOS value exceeds or falls below the mean for the age and gender matched group In order to assist in the interpretation of the measurement the background of the graph has three colored regions 1 Green denoting an area where all SOS values are higher than a T score of 1 0 which is the WHO criteria for healthy population 2 Yellow denoting an area where all SOS values are higher than a T score of 2 5 and lower than a T score of 1 0 which is the WHO criteria for Osteopenia 3 Pink denoting an area where all SOS values are lower than a T score of 2 5 which is the WHO criteria for Osteoporo sis Under certain conditions the Z score value of a measurement can be outside the range of 2 5 For example when carrying out a measurement in a patient s distal radius in a place where a bone fracture occurred in the past the Z score obtained will probably be lower than 2 5 User Guide 9 3 CHAPTER 9 Interpreting the Results of a Measurement In the case above as well as whenever a Z score result falls out side the 3 25 range 1 e has a Z value greater than 3 25 or smaller than 3 25 a re measure is suggested In such a case a pop up box will appear reading The measurement result is considered exceptional It is recommended to repeat the mea surement to certify the result Click OK to close the pop up box and then decide whether to proceed to measure the
109. d This region extends the length of the mark and toward the elbow for a distance equal to the width of the probe 8 19 User Guide Measuring SOS at the Radius STEP 5 Apply Parker Gel Apply a thin uniform layer of Parker Gel to the CM probe and on the area to be scanned The area to be scanned is a rectangular region which has the skin mark as its distal side and width equal to the width of the probe Figure 8 9 Applying Ultrasound Gel STEP 6 STEP 7 Position the probe Refer to the photographs in Figure 8 10 Position the probe from the skin mark proximally and toward the elbow parallel to the bone axis The side of the probe that is marked with a small T at the bot tom should be near the skin mark Hold the probe with both hands Fingers 1 3 of both hands grasp the probe near the base the surface applied to the scan area while fingers 4 5 palpate the limb during the scan and aid in guiding the movement of the probe correctly Only slight pres sure should be used when applying the probe to the scan area Execute the measurement cycle Press the foot pedal to begin the measurement Pressing the foot pedal is equivalent to clicking on the Start button and allows you to concentrate on the site without the interruption of other hand CHAPTER 8 Patient SOS Measurement actions When the probe is in proper contact with the area to be scanned an audible signal is heard from Omnisense
110. d be followed for cleaning the Omnisense main unit 1 Use a soft cloth lightly moistened with liquid detergent or mild soap to wipe down Omnisense s main unit surface 2 Use any cleaning detergent or mild soap suitable for external cleaning of electrical equipment to clean the Omnisense main unit Follow the instructions of the detergent or soap manufacturer Precautionary Notes e Do not allow any cleaning liquid to get into the probe con nector sockets the disk drives or the connector sockets and openings on the rear panel e Do not use cleaning agents that can damage or destroy plas tics such as ammonia acetone hydrochloride acid HCL etc The Ultrasonic Probe CLEANING The patient contact surface of the probe should be cleaned immediately after use For cleaning it is not necessary to dis connect the probe from the Omnisense unit The following steps should be followed for cleaning the probe 1 Ifa probe cap was used remove and dispose it before clean ing 2 To clean the probe of any acoustic gel or residues use only dry soft tissues or towels If required use towels that are pre moistened with a mild detergent or soap 3 The probe should be allowed to air dry if pre moistened tow els are used for cleaning 4 Visually inspect the probe to ensure cleanliness 12 2 Sunlight Omnisense 7000S 8000S Cleaning and Disinfection Precautionary Notes Do not immerse the probe in water liq
111. d before every measurement The SQV procedure is conducted for each probe separately You can verify all the probes one at a time Alternatively if you know which probe you will be using you can test only that one Probes are associated with specific sites and the probe needed for a particular site is identified on the Omnisense screen upper part extreme right when you select a site See CHAPTER 8 8 4 Understanding the Omnisense Measurement Screen on page 8 9 and the individual site methods Chapter 14 Site Measurement Methodologies for information on the correct probe to use for specific skeletal sites To conduct the SQV select System Quality Verification from the Measurement Type drop down list The screen appears as in Figure 6 2 6 2 Sunlight Omnisense 70005 80005 Measure ment Type drop down list set to System Quality Ver ification Performing System Quality Verification Figure 6 2 The Omnisense screen for System Quality Verification Measurement Measurement Type SQV A Slot selection Sunlight Omnisense Adults Site Image Change Measurement Type or Complete SQV gt Result v Normally the probe in regular use remains connected to the Omnisense rear panel If probes have not been connected see Step 3 Connect Probes page 4 14 or Step 3 Connect Probes page 4 17 for the correct procedure to connect probes Select the probe to be verified in the S ot selection box as
112. d languages To change the keyboard language choose the desired language from the list that appears This language button will appear as a scroll down button only if at least one keyboard language in addition to the default keyboard language has at some point been chosen by the process described in Step 2 Change Keyboard Language with Menu Option page 11 7 STEP 2 Change Keyboard Language with Menu Option If the language button does not appear as a scroll down button click Options gt Keyboard Settings Choose the desired keyboard language by clicking on the name of the appropriate language The selected language will now become the keyboard User Guide 11 7 CHAPTER 11 Q The Sunlight Desktop language of the device and will be added to the list of languages that appears when you click on the lan guage button Mouse Settings Changing the Mouse Settings STEP 1 Change Mouse Settings To change the mouse settings click Options gt Mouse Settings Choose the appropriate mouse settings by clicking on the chosen option for each of the mouse settings Click OK Date and Time Changing the Date and Time STEP 1 Change Date and Time To change the date and time click Options gt Date and Time Choose the appropriate date and time set tings by clicking on the chosen option for each of the date and time settings Click OK Sunlight License In the event that you would like to check or update Sunlight li
113. d small hand held probes each designed to measure SOS at one or more specific skeletal sites The basic system is offered with one probe capable of measuring SOS of the distal one third radius and the mid shaft tibia Reference databases are provided for measurements at each of the skeletal sites See 2 11 How Sup plied for a complete list of accessories Omnisense measures SOS utilizing a technology based on well established laws of physics applied to the transmission of sig nals along the bone The measurements are performed while the subject and the operator are comfortably seated A brief description of SOS measurement at the distal one third radius as an example follows First the patient personal infor mation is entered using the Windows XP graphic user inter face The CM probe is used to measure SOS along the distal one third of the radius of the arm The positioning of the distal User Guide 2 1 CHAPTER 2 22 Essential Prescribing Information one third of the radius is defined as the midpoint between the elbow and the tip of the third finger After marking the precise measurement site the operator enters measurement mode A uniform layer of Aquasonic Clear Ultrasound Gel manufac tured by Parker Laboratories Inc Fairfield NJ hereinafter referred to as Parker Gel or ultrasound gel is then applied to the hand held probe and the measurement area In case probe caps are used a probe cap should
114. e 7 3 CHAPTER 7 Patient Files Field Description Physician By default the ID of the current user will be displayed if the user is a physician If the user is an operator the physician with whom the operator is associated will be displayed if such a physician exists If the operator is associated with more than one physician this field becomes a drop down list and per mits the selection of any physician from those with whom the operator is associated Access to the patient s data may be restricted to the selected physician see next For the System Administrator SA only this field is an active drop down list allowing the SA to choose any physician ID for the current patient and if desired restrict access to that physician for the patient next This field is informational only and does not Q restrict access to other physicians or operators unless the Allow only physician to view option is checked below For more information on the different levels of user access supported by Omnisense see 10 1 User Access Levels page 10 1 7 4 Sunlight Omnisense 7000S 8000S Patient Files Field Description Allow only Secures the current patient information so physician that access is restricted to the physician to view specified above and any associated opera tors Physician level users can restrict patient data to be viewed by themselves but cannot restrict to viewing by other physi cians
115. e Sunlight Omnisense Adults applica tion User Guide 4 19 CHAPTER 4 Initial Setup Figure 4 12 Initial login dialog box Please Login Enter User Name Enter Password Once an application has been chosen the Please Login dialog box will appear This dialog box asks for a user ID and pass word if required to enter the system Sunlight recommends that you take advantage of Omnisense security features by set ting a safe password for the system administrator highest level user as well as encouraging all personnel who will use the sys tem to set passwords for themselves The procedure described below shows how to enter the system for the first time when no passwords have been set This is fol lowed immediately by the procedure for setting passwords All subsequent entry to the system should be via assigned pass words 4 20 Sunlight Omnisense 7000S 8000S 4 5 Changing the System Password Sunlight provides an initial ID and password for first time entry into the Omnisense software system The default ID is sunlight and the default password is omni all lowercase Once you have entered the system you can create your own user IDs and passwords as explained following this procedure Initial Access Procedure STEP 1 Enter Your Operator ID Number At the blinking cursor in the User Name field type the user ID provided by Sunlight sunlight e Check that you have typed it in correct
116. e complete ID number directly into the appropriate field at the top left of the Patient Information area on the screen and click the Open Patient button The system will present you with one of three possibilities e If you entered an ID correctly and it is unique the patient information will be dis played in the appropriate fields at the left of the screen e Ifthe system finds more than one match for the ID or if you entered a patient name in the Name field whether or not is unique a list of matching names will be displayed Scroll through the list and choose the cor rect patient e f no matches are found an empty list will be displayed User Guide 7 15 CHAPTER 7 Patient Files Select Patient When opening a patient file you are presented with a list of known patients Figure 7 7 illustrates the List of Patients screen Figure 7 7 List of Patients Patient gt Open Patient A 3 Date of Birth 999 Smythe Samantha 01 02 1950 Female 09 07 2003 456 Stern Jeremy 01 09 1961 Male 09 10 2004 7899 Brown Lily 05 01 1945 Female 14 10 2004 9999 O Malley George 12 08 1939 Male 15 07 2003 3344 Sand Elaine 06 04 1955 Female 16 07 2003 2345 White Sandra 09 04 1957 Female 66677 Lott Mervin 01 01 1949 Male 444 Thompson Judy 01 01 1938 Female Find by Family Name OK or Cancel A With the List of Patients open you can use any of the following to find a patient quickly e Sort the list by clicking on any of
117. e first time without a pass word Users must assign themselves a password other users can add them to the User List but cannot assign them pass words To obtain a password enter the system by typing your user ID in the Please Login dialog box no password required then select List of Users from the Administration menu Click Change Password and fill in the fields in the Change Password box that will open Leave the Enter Old Password box blank and enter the new password in the Enter New Password box and again in the Reenter New Password box To delete a user ID click on Remove Removal may be done by Users only for their own IDs regardless of whether they are a physician or an operator The exception is the System Adminis trator who is authorized to remove any user ID Before Omnisense removes a user ID you are given a chance to change your mind as shown below If a user is removed from the system his her associated patients will remain in the sys tem User Guide 10 3 CHAPTER 10 System Administration Figure 10 4 Delete user ID warning Are you sure you want to delete current Physician ID from the list Table 10 1 summarizes the rules of access for the different user types Detail on patient security and how physicians can limit access to their own patients is given later in this chapter 10 4 Patient Management page 10 20 10 4 Sunlight Omnisense 7000S 8000S User Access Levels
118. ect probe and that the Start but ton or foot pedal has been pressed Verify that sufficient coupling gel has been applied and to the cor rect area Check that the probe is in good contact with the patient s skin Validate the system by executing the System Quality Verification procedure Check that the probe is properly connected and the connector screws tightened Abort and restart the measure ment if necessary The Acoustic Contact Indicator shows green but the Acoustic Sig nal Acquisition Indica tor remains red Validate the system by executing the System Quality Verification procedure Check that the probe is properly positioned for the specific site being measured If the patient s soft tissue is extremely thick at the site mea surement may be obstructed In particular patients with a Body Mass Index BMI greater than 35 may exhibit this problem In this case additional pressure to bring the probe closer to the bone may solve the problem Result of System Quality Verification is outside phantom range 13 2 Sunlight Omnisense 7000S 8000S Call Sunlight customer support el wee System Specifications 14 1 General To ensure warranty coverage and reliable system operation defective system components should be serviced and or replaced exclusively by Sunlight authorized personnel and replacement parts should be those specified by the manufac turer 14 2 Technical Specifications
119. ed Blake GM Knapp KM Fogelman I J Clin Densi tom 2002 Spring 5 2 109 116 A New Approach to the Development of Assessment Guide lines for Osteoporosis Kanis J A et al Osteoporos Int 2002 13 527 536 User Guide 2 27 Introducing Sunlight Omnisense 3 1 7000S 8000S Sunlight Omnisense 7000S 8000S Omnisense introduces a step up in accuracy and cost effectiveness for the assessment of the risk of osteoporotic fracture It is the only quantitative ultra sound QUS system to offer the capability to measure at multi ple skeletal sites in a device intended for primary care This chapter presents a general description of the Omnisense system background information on QUS methods Omnisense technology significance of Omnisense results and use of Omnisense in diagnosis and treatment Quantitative Ultrasound Ultrasound is well established in the medical community as a safe and cost effective modality The method is widely known in its qualitative mode for example when used to obtain in vivo views of the heart or fetus Ultrasound can also be used in a quantitative mode by measuring various parameters associ ated with the propagation of a signal through the medium of interest Quantitative Ultrasound QUS is rapidly becoming accepted as a method of choice for the assessment of bone sta tus primarily because it offers reliable quick and relatively low cost results without the potentially harmful radi
120. ed measurement confir mations Figure 7 3 Patient Information dialog box Scheduler screen Patient gt New or Toolbar gt New Patient gt Scheduler A Patient Information July 2004 OK or Cancel A Table 7 3 provides further explanations on the Scheduler form fields User Guide 7 9 CHAPTER 7 7 10 Sunlight Omnisense 7000S 8000S Patient Files Table 7 3 Patient Information form fields Scheduler Field Description Last mea Displays the last measurement date surement recorded for the selected patient date In the case of a new patient it will show the date of that patient s first measurement Next mea This date is set automatically according to surement the default values set by the user in the is due at Next measurement Due After field in the Scheduler Setting dialog box 10 2 Setting System Default Options page 10 6 How ever the user can set any other desired date using the drop down lists Next mea When checked the selected patient is surement removed from the Visit Database list confirmed Exclude When checked patient is permanently patient removed from the scheduler list ignoring all from scheduling default values scheduler list Patient Files CLINICAL INFORMATION The fourth tab in the Patient Information form is for the Clinical Information screen accessed by clicking on the Clinical Info tab The patient s Clinical Information is introduced wh
121. eek ing Marketing Clearance of Diagnostic Ultrasound Systems and Transducers September 30 1997 User Guide 2 23 CHAPTER 2 211 Essential Prescribing Information ISO 10993 1992 Biological evaluation of medical devices ISO 10993 1 1992 Guidance on selection of tests ISO 10993 5 1993 Test for cytotoxicity in vitro methods ISO 10993 10 1994 Test for irritation and sensitization Sunlight products meet the provisions of the Medical Device Directive 93 42 EEC and have been certified by KEMA CE Notified Body Identification number 0344 for CE Marking of Conformity of Medical Devices Certificate number 93741CE01 issued by KEMA October 1 1999 under Annex ID Monitors printers and other interfacing accessories used with the Sunlight Omnisense 7000S Bone Sonometer must meet IEC 601 1 IEC 950 UL 2601 or equivalent safety standards How Supplied Omnisense is supplied in one of two possible versions an Omnisense 7000S desktop version or an Omnisense 8000S mobile version The Omnisense 7000S packaging includes the following e Main Unit e Keyboard and Mouse e A color display LCD monitor e Ultrasound probes according to order specification each probe contains a set of transducers some acting as trans mitters and the others acting as receivers housed tightly together in a compact holder e Foot Pedal e System Quality Verification Phantom 2 24 Sunlight Omnisense 7000S 8000S
122. elow you will find the Guide significantly more helpful as a result Definitions Throughout this Guide the terms Omnisense Omnisense Sonometer and Omnisense system are equivalent and refer to the Sunlight Omnisense 7000S 8000S product Sunlight Omnisense 7000S 8000S is a device for measuring Speed of Sound The term SOS measurement or simply mea surement will refer to the general procedure which results in an SOS value for a particular skeletal site The SOS value obtained is called a measurement result The actual application of a probe to a skeletal site and move ment of the probe over the site to acquire SOS signals is called a scan The scan movement is repeated continuously until Omnisense indicates that it has recorded an SOS value This process is called a measurement cycle To ensure consistency and reliability each SOS result is obtained by averaging results from at least three measurement cycles In summary the site is scanned repeatedly to complete a mea surement cycle The examiner conducts a number of measure ment cycles each cycle yields an intermediate SOS value The intermediate values obtained from three cycles are combined to yield the final SOS measurement result for the site The manner in which the scan is conducted for a specific skele tal site is called a method or methodology This includes correct positioning of the patient and limb to be scanned the choice of probe the way the probe is held
123. en entering a new patient to the database or editing an existing one Patient gt New or Edit Patient gt Patient Information gt Clinical Info The complete tab is shown in Figure 7 4 Patient Information dialog box Clinical Info screen page 7 11 and its fields are further explained in Table 7 4 Clinical Information form fields page 7 12 Figure 7 4 Patient Information dialog box Clinical Info screen Patient gt New or Edit Patient gt Patient Information gt Clinical Info A Patient Information xj i Clinical Info Common Osteoporosis Scheduler Smythe Samantha Physician Name Specialty Phone Dr Malcolm Jones X Family practitioner gt Chronic Diseases Disorders Drugs StartDate End Date Comments x Add Edit Delete OK or Cancel h User Guide 7 11 CHAPTER 7 Patient Files Table 7 4 Clinical Information form fields Field Physician Description The referring physician can be chosen from the existing list using the drop down menu or added to the list by simply typing in his her name in the list The same applies to the physician s specialty The physician s phone number should be added as free text Chronic dis eases disor ders Entered in free text form when necessary This information is used for future refer ence by the physician Drugs Details the prescription drugs that the patient is currently taking Up to five drugs may be
124. ent Next read Chapter 3 Introducing the Sunlight Omnisense 7000S 8000S to find out about the specific advantages of your Omnisense for bone assessment If you are using a new Omnisense system go through Chapter 4 Initial Setup If Omnisense is already at work in your clinic and you want to start SOS measurements immediately you can skip directly to Chapter 7 Patient Files continue with Chapter 8 Patient SOS Measurement and read through the following Chapter 9 Interpreting the Results of a Measurement You will need to get an operator or physician ID and a password from your Sys tem Administrator to enter the Omnisense software interface A quick reading of Chapter 5 Working with Omnisense will result in a better understanding of the overall structure of the Omnisense software System Quality Verification must be performed daily this is covered in Chapter 6 System Quality Verification The remaining chapters cover information required for admin istrating and maintaining the system which may be read when required The person responsible for managing general use of the Omnisense unit should read Chapter 10 System Adminis tration Conventions Used in this Guide Certain conventions will be used throughout this User Guide to 1 4 Sunlight Omnisense 7000S 8000S Conventions Used in this Guide aid in readability We suggest you take a moment to review the material b
125. ere if the subject population s age is to be measured in months instead of years This is commonly used for research on animals with relatively short lifespans Age Enter the starting age for which the refer ence SOS value applies Altogether there may be up to 50 values entered for each reference database Step Enter the number of years above the value entered in the Age field for which the refer ence SOS value applies These are steps of identical size such as decades Finger First click on this button activates the Age button and Step fields so you can enter reference data If you click on this button a second time before you save the database with the Cancel button see below the effect is to erase all reference data Age Step Norm and SD which you have entered Use this clear function to start fresh as an alternative to the Edit button Arrow but Use the arrow buttons to move to the next tons reference value and SD Sai o gt User Guide 17 11 CHAPTER 17 Research Mode Screen feature Norm SD Function Enter the reference SOS value Enter the standard deviation from the value entered in Norm OK Edit After entering the data for a new database click OK this saves the data entered The button changes to Edit allowing you to make corrections to the data just saved with OK See text below for detail on entering data in the DB Builder window
126. ertain minimum amount of time about 20 seconds This indicator builds from left to right when ever a signal is being acquired Elapsed time Shows the time since Start Measure ment has been pressed Note that this indicator continues to advance even if no signal is being detected Sunlight Omnisense 7000S 8000S 8 12 During an SOS mea surement cycle both the Acoustic Signal Acquisition indicator traffic light and the Acoustic Contact indica tor should be green If either indicator is red no signal is being recorded 8 13 User Guide Understanding the Omnisense Measurement Screen Indicator Function Cycle counter Shows you how many measurement cycles have been completed If five cycles have been attempted but the Result button at the bottom right of the screen is still greyed out you have not achieved three adequate measurement cycles Press Abort and begin again see below The progress bar appears during an active measurement cycle as illustrated in Figure 8 6 Figure 8 6 Progress bar during measurement cycle Measurement gt Start A Measurement oye 1 of 5 Elapsed Time 0 30 Proximal Phalanx III Ss Progress Bar Change Measurement Type or Result h A graph of the signal being received during measurement may be displayed instead of the site image seen in the figure This graph builds from left to right as the measurement proceeds To activate this d
127. es 1994 Aug 9 8 1137 1141 Kanis JA Delmas P Burckhardt C Cooper C and Torgerson D Guidelines for Diagnosis and Management of Osteoporosis Osteoporos Int 1997 7 390 406 Gluer C C Monitoring Skeletal Changes by Radiological Techniques J Bone Miner Res 1999 14 1952 1962 Discrimination of Proximal Hip Fracture by Quantitative Ultra sound Measurement at the Radius M Wise A Ben Shlomo P Hagag and S Ish Shalom Osteoporosis International 2000 11 411 416 Multi Site Quantitative Ultrasound Colles Fracture Discri monation in Postmenopausal Women Karen M Knapp Glen M Blake Ignac Fogelman David V Doyle and Tim D Spector Osteoporos Int 2002 Jun 13 6 474 479 Ultrasound Velocity Through the Cortex of Phalanges Radius and Tibia in Normal and Osteoporotic Postmenopausal Women Using a New Multisite Quantitative Ultrasound Device Dami lakis J Papadokostakis G Vrahoriti H Tsagaraki I Perisinakis K Hadjipavlou A Gourtsoyiannis N Invest Radiol 2003 Apr 38 4 207 211 Hip Fracture Discrimination Study QUS of the Radius and the Calcaneum Hans D Genton L Allaoua S Pichard C Slosman D J Clin Densitom 2003 Summer 6 2 163 72 2 26 Sunlight Omnisense 7000S 8000S References Ten Year Probabilities of Osteoporotic Fractures According to BMD and Diagnostic Thresholds Kanis J A et al Osteoporos Int 2001 12 989 995 Absolute Fracture Risk Varies with Bone Densitometry Tech nique Us
128. es only to Pay per scan result licenses With this type of license custom ers pay for the number of measurement results saved When this option is checked clicking on the Result button after a measurement will cause Omnisense to display a dialog box which asks if you are sure you want to save this result See Extending or Upgrading an Omnisense License page 10 20 for related information Physician Causes the Physician only check box in only the Patient information form to be checked by default When checked data for this patient is accessible only by the patient s physician and associated operators See 7 1 Patient Files page 7 1 and 10 1 User Access Levels page 10 1 for more details The second tab in the Options form is Settings and it is illus trated in Figure 10 6 10 8 Sunlight Omnisense 7000S 8000S Setting System Default Options Figure 10 6 System Options dialog box Settings screen Administration gt Options A OK or Cancel v The table below explains the function of the fields in this screen User Guide 10 9 CHAPTER 10 System Administration Table 10 3 System Options Settings fields Screen Item Function Show Mea The Measurement Profile is a graph of surement SOS data which builds from left to right Profile during a measurement cycle You can hide this graph by unchecking the option here When not active a picture of the anatomi cal site displays during
129. esults when used in conjunc tion with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and ultimately in the determi nation of fracture risk Multi site capability When using Omnisense you apply a simple hand held probe to the site at which SOS is being measured The probe may be applied to different sites in some cases different sites require switching probes The basic Omnisense unit is the same for all sites Currently skeletal sites at which SOS may be measured with Omnisense are the distal 1 3 radius third proximal phalanx the mid shaft tibia and the fifth metatarsal Reference databases for all of the above are available with the current release of Omnisense Preliminary studies suggest that improved diagnostic accuracy is achieved when assessment is based on SOS measurement results from multiple sites In addition patients may be assessed even when a particular site is injured or otherwise inappropriate for scanning Correlation with structural bone features Traditional measures of fracture risk are based on the density of 1 D Hans S K Srivastav C Singal R Barkmann C F Njeh E Kantorovich C C Gliier and H K Genant Does Combining the Results from Multiple Bone Sites Measured by New Quanti tative Ultrasound Device Improved Discrimination of Hip Fracture JBMR 1999 14 644 651 2 R Barkmann E Kantorov
130. eviations from the mean of age matched population 5 0 oo pt ot ot 20 25 30 35 40 45 50 55 60 65 70 75 80 85 Agelyears 12 16 34 _ 17 07 2008 Measurement Comments Comments regarding the measurement for a particular patient may be added by clicking the Measurements Comments button on the measurement screen When the button is clicked a dia log box will open enabling the physician to enter comments per examination per site per date Up to 256 characters of the text entered will appear in the measurement report This button will be enabled when opening editing a patient file After perform ing a further measurement previous comments will not appear Deleting a Measurement Result In certain situations you may want to delete a particular mea surement result for a patient In this case you may delete a measurement result by clicking on the right hand mouse button while the cursor stands on the result you wish to delete The screen seen in Figure 9 7 Patient measurement delete mea surement result page 9 9 will appear Click Delete Selected 9 8 Sunlight Omnisense 7000S 8000S 9 3 Multi Site Measurements Measurement and press Yes to confirm The selected measure ment is now deleted from the system Please note that if you would like to delete a measurement car ried out as part of the multi site measurement procedure detailed in 9 3 Multi Site Measurements page 9 9 you must fir
131. ext ten years Figure 9 5 Patient risk assessment Details 8 6 xl Patient Risk Assessment Ten year absolute risk for osteoporotic fracture 18 To obtain the Patient Risk Assessment score click on the right hand mouse button while the cursor stands on the current mea surement result The screen seen in Figure 9 6 Patient mea surement details page 9 8 will appear Click Details to view the Patient Risk Assessment screen seen in Figure 9 5 Patient risk assessment page 9 7 Please note that Patient Risk Assessment calculation cannot be performed based on ORI results ORI is described in 9 3 Multi Site Measurements page 9 9 User Guide 9 7 CHAPTER 9 9 2 Interpreting the Results of a Measurement Figure 9 6 Sunlight Omnisense Adults Patient Measure Administration Research R amp D Help eels pote al Measurement Type E Single Site Z Site 8 1 DISTAL RADIUS Probe CM Patient Information Measurement History Patient ID 3344 i Family Name Sand First Name Elaine Measurement Data Patient Measurements Date sos Patient measurement details Previous value 204 4 Current value 6 amp fs Ezi ksj r 4169 4071 F 3973 paspu punog jo paadg g g a T Score Number of standard deviations from the mean of normal young adults 2 Score Number of standard d
132. eyboard Font will apply in all applications when changed on the Sunlight Desktop Similarly if these settings are changed in any application the new settings will apply also on the Sun light Desktop 4 24 Sunlight Omnisense 7000S 8000S 4 11 Setting the System Time Any change in the language of the Sunlight Desktop will apply only to the Sunlight Desktop To change the language of an application installed on the Desktop change the language within the application software Any change of language in one application will apply in other applications as well except in special cases For details about setting options for the Sunlight Desktop see Chapter 11 The Sunlight Desktop page 11 1 Setting the System Time Select Options from the Administration menu and select the Set tings tab Figure 4 16 System Options dialog box Settings screen Administration gt Options A Options Eq Defaults Settings Scheduler License Distributor m Y OK i le M Measurement Sound r System Quality Verification Show all Show last 3 months Show last year C Show last month System setup Date Time Keyboard Cpi Mouse Language amp Regional OK or Cancel A m Settin Click on Date Time at the bottom of the dialog box and choose the Time Zone tab The Time Zone dialog box is illustrated next To view the list of available time zone options click on the drop down arrow to the ri
133. f the moving average of the SOS results as a function of age for the North American female distal one third radius bone For that popula tion the moving average SOS increases to a peak of 4158 m sec at the age of 41 with population standard deviation of 102 m sec and declines thereafter The peak mean and standard devia tion results are used for generating T scores The largest decline about 15 m sec year is observed around age 58 eight years past the mean age of menopause At older ages 65 to 90 the decline slows to about 2 5 m sec year Among the North American women aged 60 90 35 had T scores less than 2 5 and 42 had T scores between 2 5 and 1 0 Similar behavior was found for all other reference curves 2 6 Sunlight Omnisense 7000S 8000S Clinical Studies Table 2 1 SOS Measurements by Age Distal 1 3 Radius Mean SD in m sec NPER MidEasti North Am Asian Asian Females Females Females Males 20 29 4108 95 4103 107 4115 103 4012 108 30 39 4161 101 4150 93 4168 104 4122 91 40 49 4167 98 41614131 41864112 41354127 50 59 4115 128 4095 131 4069 157 4073 117 60 69 3988 151 3972 141 3950 148 4056 133 70 79 3931 129 3949 126 3885 193 3993 142 80 90 3879 159 3921 149 3797 182 3970 177 All 4082 151 4083 146 4116 160 4070 133 Figure 2 1 Moving Average SOS by Age Distal 1 3 Radius SOS m sec 20 30 40 50 60 70 80 90 Age North American Caucasian Females Reference D
134. g box Administration gt Site Order A Site Order x t DISTAL RADIUS METATARSAL V MEAS0001 CM PROXIMAL PHALANX III MEAS0001 CM MEAS0001 CR MEAS0001 cs ve Cancel or OK v Click on a site to highlight it and then use the arrow buttons at right to move the site to any desired position The Site drop down list will reflect the new ordering Site Order is typically most useful for managing the long site lists which can accumulate in research work User Guide 10 25 CHAPTER 10 10 26 Sunlight Omnisense 7000S 8000S 10 7 System Administration Extending or Upgrading an Omnisense License Two types of licensing are available with Omnisense Table 10 5 License types License type Pay per scan Description This license is purchased in increments of use such as 100 SOS measurements Clicking Result at the end of the mea surement is counted as a single use Measurement at multiple skeletal sites of the same person are counted as one scan provided that such scans are con ducted on the same date Unlimited There are no restrictions on the number of SOS measurements with this type of license If you have the first license type you can use the License Sta tus option to extend your license or upgrade it to the Unlimited type An extension must be arranged directly with Sunlight or with its authorized distributor or representative Select License Status from the Administration menu The d
135. ght of the first line Select the desired time zone and click OK Figure 4 17 User Guide 4 25 CHAPTER 4 Initial Setup Next click on the Date amp Time tab Enter the date and time in the indicated fields using the Up Down or selection arrows Click OK and the system date and time are set Figure 4 18 Figure 4 17 Time Zone screen Administration gt Options gt Settings gt Date Time gt TimeZone A B23 45 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 OK or Cancel v 4 26 Sunlight Omnisense 7000S 8000S 4 12 4 13 Setting System Default Options Figure 4 18 Date Time settings Administration gt Options gt Settings gt Date Time A Date and Time Properties 21x Date amp Time Time Zone Internet Time GMT Greenwich Mean Time Dublin Edinburgh Lisbon London z GMT 1 Mean Time Dublin Edinburgh Lisbon London GMT 1 Amsterdam Berlin Bern Rome Stockholm Vienna GMT Belgrade Bratislava Budapest Ljubljana Prague GMT 01 00 Brussels Copenhagen Madrid Paris GMT 01 00 Sarajevo Skopje Warsaw Zagreb GMT 01 00 West Central Africa GMT 02 00 Athens Istanbul Minsk GMT 02 00 Bucharest GMT 02 00 Cairo GMT 02 00 Harare Pretoria GMT 02 00 Helsinki Kyiv Riga Sofia Tallinn Vilnius GMT 02 00 Jerusalem GMT 03 00 Baghdad GMT 03 00 Kuwait Riyadh GMT 03 00 Moscow St Petersburg Volgograd GMT 03 00 Nairobi _ GMT 03 30 Tehr
136. h measurement The CV was reported for all measurements as well as stratified by operator and by menopausal status The variance of each CV was also calculated so that 95 confi dence intervals could be reported Fifteen subjects were mea sured 10 premenopausal women and 5 postmenopausal women This kind of precision result is often called Short Term Precision Since there were 15 subjects measured by three different opera tors a total of 45 pairs of repeated SOS measurements are available to assess the reproducibility of repeated measure ments The overall CV for the radius was 0 40 95 CI 0 39 to 0 41 For pre menopausal women the radius CV was 0 29 and for postmenopausal women the CV was 0 57 The short term precision results for all skeletal sites is shown in Table 2 5 Table 2 5 Precision Test Results for each of the skeletal site RMS Intra Operator CV Radius 0 40 Phalanx 0 81 Metatarsal 0 66 Tibia 0 45 Conclusions The in vivo precision reproducibility expressed by CV for the Omnisense system when performing repeated SOS measure ments at the various skeletal sites was very good regardless of the ultrasound probe the system the probe connecting slots within each main unit or the operator used to perform the mea surement Results indicated a high level of reproducibility regardless of the hardware used or the operator performing the measurements and demonstrated a very narrow dis
137. ht Omnisense 7000S 8000S A brief description of quantitative ultrasound methods in general and Omnisense technology in particular Specific advantages of Omnisense for bone status assessment CHAPTER 4 Initial Setup Unpacking cable connections and initial access to the Omnisense software CHAPTER 5 Working with Omnisense A high level overview of Omnisense functions A useful primer and general navigational aid CHAPTER 6 System Quality Verification A daily procedure to insure correct functioning of probes and validity of SOS results CHAPTER 7 Patient Files This chapter describes patient files and shows how to create a new patient file and open an existing patient file CHAPTER 8 Patient SOS Measurement General procedure for SOS measurement presented using the distal 1 3 radius as an example skeletal site CHAPTER 9 Interpreting the Results of a Measurement Explains the SOS measurement results provided by Omnisense and their significance CHAPTER 10 System Administration l 2 Sunlight Omnisense 7000S 8000S Outline of Contents Covers the administration of users user security and differ ent access levels patient management and security and sys tem defaults CHAPTER 11 The Sunlight Desktop Describes the Sunlight Desktop and utilities available on the Desktop CHAPTER 12 Cleaning and Disinfecting Omnisense The procedure and materials to be used for cleaning and disinfection of Omnisense CHAPTER
138. ia log box shown below is displayed Extending or Upgrading an Omnisense License Figure 10 18 License Status dialog box Administration gt License Status A License Status Current License Type Unlimited License Total Scans Unlimited Used Scans 22 New Order New License Type Unlimited License License Information is Ok Exit or Print A The top of the window shows the type of your current license the bottom part allows you to order a license extension or upgrade The procedure is straightforward To order a license extension or upgrade 1 Ifyou are extending a Pay Per Scan license enter the num ber of use units desired in the New Order field If you wish to upgrade your license select the type of license you want in the New License Type drop down list 2 Click Print A form is printed which contains your order information and codes related to your specific Omnisense unit Click Exit 3 Fax the form to Sunlight or to its authorized distributor or representative 4 You will receive a fax in return with a 32 character code and in the case of a prepayment by use order the number of new use units User Guide 10 27 CHAPTER 10 System Administration 5 Choose once again Administration gt License Status Click Update in the dialog box and the window shown below is displayed Enter the 32 character code and number of additional use units in the renewal if applica
139. iam 26 09 00 44 13 34564356 Medicine St 77 don UK Belling Marvin 14 01 00 49 30 667555 Berlin Germany Brandt Dennis 14 01 00 49 30 66778655 Berlin Germany Kappert Francheska 04 02 00 49 30 445557 Berlin Germany Schwarz Jane 04 02 00 1 212 6544578 NY NY Hoffmann Asta 04 02 00 49 30 2345234 Berlin Germany Berghof Hans 04 02 00 49 30 345345 Berlin Germany Schefer Alesja 04 02 00 49 30 444433 Berlin Germany Kayser Beate 04 02 00 49 30 7895565 Berlin Germany Smith Felix 04 02 00 49 30 2228977 Berlin Germany Bookhagen Robert 14 02 00 49 30 45632333 Berlin Germany SN 20072099 Software version 2 2 2428 op Sunl igh t Visit Database List User Guide v 7 21 CHAPTER 7 Patient Files 7 22 Sunlight Omnisense 7000S 8000S Patient SOS Measurement 8 1 8 1 User Guide Preparing the Environment for a Patient As in any clinical setting having the correct supplies on hand is important for efficient operation For Omnisense only a few items are required Table 8 12 Supplies required for use with Omnisense Item Purpose Parker Gel Provides acoustic contact between the probe and the site being measured Probe Used to cover the probe surface in touch Caps with the subject skin during measurement Optional for better hygiene A new cap should be placed with every measurement according to a procedure detailed later in this chapter Disinfec Used to disinfect probe
140. ich C Singal D Hans H K Genant M Heller and C C Gliier A New Method for Quantitative Ultrasound Measurements at Multiple Skeletal Sites First Result of Precision and Fracture Discrimination J Clin Densitom 2000 3 1 7 User Guide 3 5 CHAPTER 3 Introducing Sunlight Omnisense 7000S 8000S bone However it is well known that bone strength depends on a variety of factors of which density is only one In particular structural features play a key role in determining a bone s abil ity to resist trauma As a simple illustration bones such as the tibia and radius can withstand much greater stress along their tubular axis the direction which naturally carries body weight than at right angles to this axis despite the fact that density remains identical in both situations Ongoing studies suggest that Omnisense SOS results are related more directly to bone strength than a simple density measure such as Bone Mineral Density BMD Increased predictive ability As described above Omnisense brings two advances in accu racy to osteoporotic risk assessment First its multi site capa bility makes it possible to improve the statistical significance of results as compared with single site measurement Second it goes beyond mineral density to assess bone strength with a measure that correlates with a range of factors The two advances combined may be expected to provide a risk assess ment capability more reliable than has
141. ick on the application s icon on the Sunlight Desktop and begin work User Guide 11 3 CHAPTER 11 Q iN The Sunlight Desktop Adding New Applications Adding A New Application to the Sunlight Desktop STEP 1 STEP 2 STEP 3 STEP 4 Begin Procedure Click Start gt Add application Add New Application Software Follow the instructions on the screen You will be instructed to choose a drive and insert the disk con taining the software that will enable the application Further instructions will appear on the screen after the disk is inserted In some cases you will be asked to insert a license number to enable the software you will receive this license number from your dis tributor as part of the installation kit Attach Application Hardware Attach the hardware required to operate the applica tion as indicated in the User Guide provided with the specific application Complete Procedure The new application should now appear on the Sun light Desktop Please confirm this by verifying that the icon for this application on the Sunlight Desktop appears Click on the icon to begin work with the new application Removing Applications STEP 1 Begin the Procedure Select Start gt Add application 11 4 Sunlight Omnisense 7000S 8000S 11 3 Desktop Utilities STEP 2 Complete Procedure Insert the disk that includes the software for the application that you want to remove Click on the Remove Ap
142. ient before beginning the scan that these indicators are solely to guide the operator in appropriate positioning of the probe and have no bearing on bone status We now complete the procedure for measuring SOS at the Dis tal 1 3 Radius Sunlight Omnisense 7000S 8000S_ 8 16 Measuring SOS at the Radius be Completing the measurement STEP 1 Set Omnisense to Measurement Mode Start measurement If you have not already done so click the Measure ment icon on the toolbar or choose Measure from Far the menu to display the measurement screen Figure 8 5 on page 10 Patient information appears at left as usual while the right side displays indicators of the progress of measurement STEP 2 Choose the correct probe The correct probe type for use with the currently selected site is indicated on the Omnisense screen at the upper right Note that probes are color coded for quick identification the probe indication on the screen shows the correct probe color The CS probe is coded light green the CM probe the one used for the Radius is coded violet and the CR probe is coded yellow STEP 3 Disinfect the probe use of probe cap Probes should be either disinfected before each patient use or used together with a probe cap Disinfection must be done with specially pre moist ened towelettes not by immersion of any kind See chapter 11 for disinfection towelettes that have been approved for use with Omnisense F
143. ient is not experiencing any discom fort Figure 15 5 Grasping the patient s finger 9 Hold the probe with your dominant hand so that fingers 1 3 are grasping it near the base the surface applied to the scan area and apply it to the proximal phalanx The side of the probe that is marked with a small T at the bottom lies at the marked point on the skin and the remainder of the 15 4 Sunlight Omnisense 7000S 8000S To scan move the probe first in the medial direc tion about 90 degrees then back to the start point and further in the lateral direction again 90 degrees and return to Start The Proximal Phalanx of the Third Finger probe s surface extends distally toward the medial phalanx Use the fingers 4 5 to palpate the limb during the scan and aid in guiding the movement of the probe correctly Figure 15 6 Correct position of the probe for scanning 10 Press the foot pedal to begin the measurement cycle When the probe is in proper contact with the area to be scanned an audible signal is heard from Omnisense 11 The scan is executed by moving the probe around the proxi mal phalanx from its dorso medial to its dorso lateral part in an arc of about 180 degrees but no wider During the scan movement the probe is held perpendicular to the bone at all times never at an angle The movement is repeated until the measurement cycle is complete A single scan movement through 180 degrees should take
144. ight Desktop but have been approved for use with the Omnisense device Such applications can be added to the Sunlight Desktop by installing the appropriate software and attaching the appropriate hardware An icon for such an application will appear on the Desktop only once the appli cation is installed Applications which have not been approved for use with Sun light Omnisense cannot be used with the device 11 2 Sunlight Omnisense 7000S 8000S Adding and Removing Applications Please note that clicking on an icon of an enabled application whose hardware is not attached to the device will open the software of the device However measurement with this application will not be possible without attaching the relevant hardware Please follow the procedure below to add each of the applica tions which you have purchased to your Omnisense device Adding Pre installed Applications Adding Pre installed Applications to the Sunlight Desktop STEP 1 Attach Application Hardware Attach the hardware required to operate the applica tion as indicated in the User Guide or Help File provided with the specific application STEP 2 Insert Hardware License Number For some applications the application will require that you insert the hardware license number in order to begin work Follow the instructions in the appli cation User Guide or Help File for inserting the license number STEP 3 Complete Procedure You will now be able to cl
145. indow prior to a scheduled date of examination during which the Scheduler will remind you to contact the patient There are four setting options 1 week 2 weeks 1 month or a number of days that is typed by the user The visual indication for the Reminder activation is the change of patient status on the Visit Database list SCHEDULING INFORMATION page 7 8 as the patient record icon becomes yellow This happens when current date is within Reminder Period time window Example If the next examination is scheduled for 1st of April 2004 and the Reminder period is set for 2 weeks on March 15 2004 the patient record on the Visit Database will be tagged yellow This would mean that it is time to contact the patient to remind him or her of the appoint ment User Guide 10 13 CHAPTER 10 10 14 Sunlight Omnisense 7000S 8000S System Administration Screen Item Post Due Date Period Function This screen item sets the Post Due Date period namely how much time after the previously planned examination the sys tem would still notify the user of the date with a yellow marker After this period the icon would turn red The available options are 1 week 2 weeks or a number of days set by the user Example If an examination was sched uled for April 1 2004 and the Post Due Date Period is set to 1 week then on April 8 2004 the system would change the yellow icon to red exactly one week
146. introduced in the patient s clinical information Drugs entered in the patient s data can be deleted or added as the need arises In order to add edit or delete drugs from the list use the lower three buttons in the screen Add Edit Delete These buttons apply only to the drugs list and are the only means to add edit delete drugs from the list see Figure 7 5 When you need to add edit or delete drugs from the list the screen shown below opens for each drug Its fields are explained in Table 7 5 7 12 Sunlight Omnisense 7000S 8000S Patient Files Figure 7 5 Prescription drugs editing screen New Drug for Patient 121 x Drug name Daily Dosage mg Start date e Month Year E E End date Day Month Year E EE Comments ooo Table 7 5 Prescription Drugs Editing Screen Field Description Drug name The name of the drug entered by typing as text Daily The daily dosage in mg entered as a num Dosage ber Start date The date on which the patient started taking the drug End date The date on which the patient discontinued using the drug Comments Any comments you deem necessary regard ing that particular drug Entered as free text User Guide 7 13 CHAPTER 7 Patient Files 7 2 Opening a Patient File A patient file must be opened to conduct an SOS measurement to view or print a patient s SOS measurement history and to view the pa
147. ion of each item User Guide 17 7 CHAPTER 17 Research Mode Figure 17 3 Advanced Options dialog box Administration gt Options gt Advanced A i Options x Settings Scheduler License Distributor 4 j 4 gt Save in Database M Save Velocity I Save Time scale I Save Depth Research settings I Hide Research window apply Cancel or OK v Table 17 3 Site Design parameters Dialog item Description Save Velo Causes each sample SOS point of a city measurement to be saved Normally only the final result is saved Save Depth For each point of the measurement the average soft tissue depth is saved Save Time Saves the elapsed time at each point of Scale the measurement This allows assess ment of operator pauses which interrupt the scan Save Traces Traces are three streams of raw data corresponding to SOS signal times from which other parameters of a scan are calculated With this option the trace data are saved 17 8 Sunlight Omnisense 7000S 8000S Working with Reference Databases Dialog item Description Hide Hides the Research information area at Research the bottom left of the Omnisense window Research Mode screen 17 3 Working with Reference Databases The Research option allows the investigator to enter new popu lation SOS data which can then be displayed as a reference to which patient results may be compared To build such a reference
148. ions dialog box Scheduler screen Administration gt Options gt Scheduler A x Defaults Settings Scheduler License Distributor Next Measurement Due After Reminder period C 1 year C 1 week C 2years C 2weeks G E months 1 month s fao d Post due date period A DE fal eee C Apply C 2weeks C fF days OK or Cancel A User Guide 10 11 CHAPTER 10 System Administration The table below explains the function of the fields in this tab Table 10 4 System Options Scheduler Settings Screen Item Next Mea surement Due After 10 12 Sunlight Omnisense 7000S 8000S Function This screen item selects the default time period between measurements The avail able options are 1 year 2 years ora period in months entered by the user Example If the option 1 year is selected and a measurement was per formed on December 1 2003 the system will automatically schedule the patient s next measurement to December 1 2004 one year later Note The factory default setting for all patients is one year between examina tions The user is free to set any other desired default period as described above or a patient specific date using the patient Scheduler form as described in Measurement Scheduling page 7 6 Setting System Default Options Screen Item Reminder Period Function This item is the core of the Scheduler fea ture It sets the default for the time w
149. isplay select Administration gt Options gt Settings and click the appropriate checkbox However Sunlight recommends CHAPTER 8 Patient SOS Measurement this feature not be activated for normal site measurement to avoid screen distractions and allow the operator to concentrate on the measurement Region of Interest ROI When the progress bar reaches the end of its range the traffic light and acoustic signal indicators change to crossed flag icons indicating a successful measurement cycle has been completed The anatomical picture is replaced by a graph of the SOS values recorded and an audible beep is heard The right side of the screen appears as shown in Figure 8 7 Figure 8 7 Measurement cycle completed Completion of a measurement cycle A Measurement Cycle x of E Elapsed Time 0 21 0 20 40 60 80 100 120 140 160 180 200 Next Cycle or Abort vy There are three buttons at the bottom of the screen which relate to starting restarting and ending a cycle as well as the entire measurement They appear both during and upon completion of each cycle Table 8 15 describes them Sunlight Omnisense 7000S 8000S 8 14 8 15 User Guide Understanding the Omnisense Measurement Screen Table 8 15 Measurement cycle start end buttons Button Start Restart Next Cycle Function Click to begin the cycle The elapsed time indicator starts running However other indicators will become
150. ite Order Options Applications User Guide 5 3 CHAPTER 5 Working with Omnisense Table 5 1 Measurement operations Measurement Operations Operation Description Start Mea To start a patient SOS measurement surement the patient s file must first be opened For an SQV measurement proceed directly with one of the following To start the measurement e Click on the Measurement button on the toolbar or e Select the Measure menu head ing Note Once a Measurement operation has been started in one of the above ways Patient Import Export and all Administration functions are not avail able During a typical work day with Omnisense the Measurement screen is continuously displayed while patient files are opened and closed Manage ment operations are used relatively infrequently Switching to To enable Management operations Managemen If a patient file is currently open operations Close the patient file If the results of a measurement are displayed Choose Save or Abort then close the current patient file If a measurement is currently in progress Complete the measurement or click Abort close the current patient file 5 4 Sunlight Omnisense 70005 80005 Basic Operations Measurement Operations Operation Description Measurement This part of the screen has two indica tors which provide feedback during SOS measurement These guide the operator and insure c
151. l Prescribing Information 2 5 Precautions The Omnisense probe should not be used on subjects with breached skin or open sores on the skin area that comes with contact with the probe Use Omnisense only indoors in a clean dry environment To prevent fire or electric shock do not open or expose the Omnisense main unit to rain or moisture Do not operate or store Omnisense near a heat source or air conditioner and always store the System Quality Verifica tion SQV Phantom near the Omnisense main unit The system is not sterile However the probe must be cleaned and disinfected before each patient session The proper cleaning and disinfection procedure is described in this User Guide in Chapter 11 Cleaning and Disinfecting Omnisense page 11 1 Omnisense provides no protection against the harmful ingress entry of liquids Hence when cleaning the unit avoid applying liquid near probe connections and sockets SQV phantom and probes should not be immersed in liquid of any kind Dry or pre moistened wipes may be used to clean them Use Sunlight recommended and approved ultrasound cou pling gels with the Omnisense sonometer to generate and maintain acoustical contact of the probe with the skin Parker Aquasonic Clear Ultrasound Gel is for external use only When applying ultrasound coupling gel do not use a Q tip an examination glove treated with talc or any other appli cator that may introduce fibers or
152. lanx III Site1 RAD RAD RAD PLX PLX MTR Site2 TIB MTR PLX TIB MTR TIB oy 0 541 0 669 0 559 10 481 0 584 0 422 an 0 467 0 402 0456 0 522 0 442 0 627 Description of the cross sectional studies We now compare the discrimination between fractured and non fractured subjects using a ROC analysis for the single site case vs the multi site case The Area under the ROC curve AUC takes into account both the sensitivity and specificity of the diagnostic technique the higher the AUC the higher the diagnostic power on the average Please note that since the ORI parameterization improves in general the diagnostic sensitivity without loss of specificity therefore only small increase in the AUC value can be expected 2 16 Sunlight Omnisense 7000S 8000S Clinical Studies Two such studies were performed both in the Middle East Table 2 8 depicts the prevalence according to the WHO criteria for the fractured and non fractured subjects all hip vertebral and wrist fractures as well as the Area under the ROC curve AUC for the individual sites and specific multi site combina tions User Guide 2 17 CHAPTER 2 Essential Prescribing Information Table 2 8 Discrimination of fractured F and non fractured NF subjects in a cross sectional study described in 2 7 3 Cross Sectional Study of Hip Vertebral and Wrist Fracture Risk above T scores are based on the Mid
153. lick OK and choose the appropriate drive in the Choose Drive window that will appear seen in Figure 10 9 Choose Drive window page 10 16 The device will then inform you that the logo has been added and will now appear in measurement reports this message is seen in Figure 10 10 Logo OK win dow page 10 16 User Guide 10 15 CHAPTER 10 System Administration Figure 10 9 Choose Drive window Options xi Defaults Settings Scheduler License Distributor Acs gt Clinic Choose Drive Addres Removable Drives Drive A Floppy 1 44 Mb Phone E mail Add your logo to report Figure 10 10 Logo OK window Defaults Settings Scheduler License Distributor x x Clinic f xi E Your logo file is in the accepted format and will be added to all Address j measurement reports that you i ance E a print Phone E mail Clapply To replace a logo that you have already installed in the device simply repeat the above procedure with a new logo file The new logo will replace the previous logo The fifth screen in the options menu is the Distributor tab and it is used to introduce the distributor s information in the spaces provided namely name address phone number fax number and e mail address see Figure 10 11 10 16 Sunlight Omnisense 7000S 8000S User Interface Language Selection Figure 10 11 System Options dialog box
154. ly e Ifit is incorrect use the backspace key to delete and retype it correctly e Press TAB to move to the Password field STEP 2 Enter the System Password In the Password field type in the password pro vided by Sunlight omni Asterisks the symbol are displayed when you type into the Password field instead of the actual password characters STEP 3 Complete Initial Access To complete the access procedure click OK This will bring up the main Omnisense screen Changing the System Password When you enter Omnisense with the Sunlight provided user ID and password you are operating at the system level This is the highest level of access usually reserved for the person respon sible for system administration The next step is to change the User Guide 4 21 CHAPTER 4 Initial Setup Sunlight password for system level access to one of your choice First select List of Users from the Administration menu this brings up the User List screen Figure 4 13 User List screen Administration gt List of Users A User List Ea Physician Name e Add Amenda O oO Jerry Rose O Smith Remove Remove apply Associate Current user sunlight Change password e OK or Cancel A Choose Change Password and the following dialog box will appear Figure 4 14 Change password dialog box Administration gt List of Users gt Change Password A Change password of su
155. maintain all copyright proprietary or other notices on the Soft ware must not decompile disassemble or reverse engineer the Software and must not make it available to any party except those using the Software as part of their duties Limitation of Liability In no event shall Sunlight be liable for any direct indirect special incidental or consequential losses damages or expenses whether based on contract tort or any other legal theory and whether or not advised of the possibility of such dam ages Manufacturer s Warranty Thank you for purchasing this Sunlight Medical Ltd product Please fill out the attached warranty card photocopy it and fax it to 39 0542 642543 SUNLIGHT MEDICAL LTD SUNLIGHT OMNISENSE 7000S 8000S UNIT ULTRASONIC PROBES EXCLUSIVE AND LIMITED ONE YEAR WARRANTY A Warranty Coverage 1 The products covered by this warranty are the following i Sun light Omnisense 7000S 8000S System Unit and ii Ultrasonic Probes hereinafter the Product or Products Products manufactured by Sunlight Medical Ltd the Com pany are covered by a warranty against defects in materials or workmanship If the Company receives notice of such defects dur ing the warranty period the Company shall either repair the Prod uct or replace it with a new Product or equivalent at its sole discretion If the Company is unable to repair or replace a defec tive Product it shall refund the Product s purchase
156. me Zone Sree arrien bata cave od eth a id hee hace 4 26 Date Time settings siui he tae end a Mae ee ee eee els 4 27 New user access to Omnisense 0 0 cece ee eee 4 28 Setting a new password with the List of Users screen 4 29 Exit dialog bok eies n none amp Hg Bee SE ee ee eee 5 13 Phantom 45 epes ged saat saute E E D E KER dion sear gaatedk 6 1 The Omnisense screen for System Quality Verification 6 3 Positioning the phantom on the probe for SQV 6 6 Visual inspection of contact between probe and phantom 6 6 Measuring the phantom SOS during SQV 2 6 8 SQV measurement cycle completed 0 00 e eee 6 9 Entering the expected phantom SOS value 6 10 SOV result screen 5 sya Gu sae us oe ee RAS ee 6 11 Patient Information dialog box Common screen 7 2 Patient Information dialog box Osteoporosis screen 7 6 Patient Information dialog box Scheduler screen 7 9 Patient Information dialog box Clinical Info screen 7 11 xvii Figure 7 5 Figure 7 6 Figure 7 7 Figure 7 8 Figure 7 9 Figure 7 10 Figure 7 11 Figure 7 12 Figure 7 13 Figure 8 1 Figure 8 2 Figure 8 3 Figure 8 4 Figure 8 5 Figure 8 6 Figure 8 7 Figure 8 8 Figure 8 9 Figure 8 10 Figure 9 1 Figure 9 2 Figure 9 3 Figure 9 4 Figure 9 5 Figure 9 6 Figure 9 7 Figure 9 8 Figure 9 9 Figure 9 10 Figure 9 11 Figure 9 12
157. n Maxi If the angle at which the probe is applied to the site mum tilt exceeds that specified here Omnisense will stop angle recording SOS and the Acoustic Signal Acquisition indicator will register failure to acquire When the probe is returned to a correct alignment Om nisense will automatically resume signal acquisition and the indicator will show green The tilt angle is the angle between the surface of the probe and the surface of the bone A 0 angle is created when the probe is parallel to the bone After checking that all parameters are correct click OK The new site is now defined and will appear on the Site Selection list SOS measurements conducted with the new site selected will follow the parameters as you have entered them Editing a User Site To make changes to a site you have created select Edit Site from the Research menu The Site Design dialog box is dis played exactly as it does for Copy Site Enter any desired changes and click OK To remove a User Site select the site and choose Delete Site from the Research Menu Special Options for Research In the Research version of Omnisense the Options item under the Administration menu provides an additional tab labelled Advanced This dialog box allows you to set a number of parameters relating to the type of data that are saved from SOS measurements Note that this data consumes hard disk space The dialog box is illustrated below followed by an explanat
158. n To ensure clar ity each of the three steps is presented below as a detailed procedure Please read the sections which follow carefully before proceeding Sunlight Omnisense 7000S 8000S 8 2 8 2 IN Setting the measurement type Measurement Type E Single Site 7 8 3 User Guide Readying Omnisense for an SOS Measurement Readying Omnisense for an SOS Measurement The procedure below describes your interaction with the Omnisense software in preparation for an SOS measurement This is done first so that you are free to concentrate on the scan site during the measurement itself Readying Omnisense STEP 1 STEP 2 Select measurement type If you have not already done so select Single Site Measurement in the Measurement Type selection box Refer to Figure 8 1 The other measurement type is System Quality Verification described in Chapter 6 System Quality Verification or Multi Site described in Chapter 9 Section 9 2 Multi Site measurements Identify the patient All SOS measurements must be conducted with ref erence to a specific patient known to the Omnisense software Please refer to Figure 8 1 Open the patient file for whom the SOS measure ment is to be conducted Click on the Open Patient button at the upper right of the patient information section of the screen or choose Open Patient from the Patient menu Select the patient from the list which is displayed the patie
159. n indicates that the area under the ROC curve unadjusted for age is 0 63 95 CI 0 61 0 79 The fracture odds ratio unadjusted for age is 2 16 95 CI 1 46 3 19 and the age adjusted odds ratio is 1 75 95 CI 1 15 2 65 For every 100 m sec decrease in SOS the odds of fracture increase by about 50 and for every decrease of 162 m sec in SOS the odds of fracture doubles Conclusions This case control based study has shown that the Omnisense can significantly discriminate between osteoporotic hip fracture subjects age matched elderly non fracture 2 8 Sunlight Omnisense 7000S 8000S 21 3 Clinical Studies subjects and young healthy subjects This finding is noted despite a high likelihood that there are a significant number of osteoporotic subjects in the non fracture group The odds ratios found in this study can be considered fracture risk estimates and are comparable to those of other bone assessment devices Cross Sectional Study of Hip Vertebral and Wrist Fracture Risk Objective To determine the ability of Omnisense Speed of Sound measurements to discriminate subjects with major osteoporotic fractures from non fracture subjects and to deter mine the fracture risk estimate Methods The study was carried out by one investigator in the Middle East A total of 274 Caucasian women were recruited into three fracture groups hip vertebral and wrist and an eld erly non fracture group All subjects were 55 to 85 yea
160. nYi Road Shanghai 200051 China Tel 86 21 623 70508 Fax 86 21 623 70509 e mail support sunlightnet com SOFTWARE LICENSE WARRANTY AND LIMITATION OF LIABILITY Sunlight Omnisense 7000S 8000S The terms of the Software License Product Warranty and Limitation of Liability specified below are an essential part of your agreement with Sunlight Medical Ltd Sunlight By using any Sunlight equipment and or software described in this manual you agree to be bound by these terms If you do not agree to these terms you must contact your Sunlight representative within five days of receipt and we will arrange to enter into a written agreement or for your return of the equipment and software Software License All software hereinafter the Software is supplied under this license only Sun light retains all title to and all copyrights to the Software and any copies thereof Purchaser is granted a non exclusive royalty free license to use the Software solely on the equipment on which it is installed at time of delivery or on the equipment for which it is intended to be installed if not installed when deliv ered for as long as purchaser shall own such equipment The Software may be used for performing measurements on this equipment in the normal course of the purchaser s business but for no other purpose or business No license is pro vided to use the Software for Multi Site quality control or data review purposes Purchaser must
161. ng the results see 15 5 Practice Mode page 15 18 About General information on Omnisense and installed software version User Guide 5 11 CHAPTER 5 5 2 Q Working with Omnisense Changing Users and Shutdown When shutting down Omnisense do not simply turn off the power switch This could cause permanent loss of data Follow the prescribed shutdown procedure It is entirely acceptable to leave the Omnisense unit on for long periods of time However after installing a peripheral device such as a printer or running a utility such as System Upgrade you will often be required to restart the system also known as Reboot You may also want to turn off Omnisense for reasons of energy conservation The procedure described below is also used when you want to reenter the system with a different user ID This is useful if for example you are transferring responsibility for SOS measure ments to an assistant and wish to limit that person s access to sensitive patient data In all of the above situations follow the procedure below Shutdown Procedure STEP 1 Terminate the current measurement If an SOS measurement is currently in progress complete the measurement or abort it by clicking on the Abort button After a measurement has com pleted save or abort the results data STEP 2 Close the current patient file Any currently open patient file must be closed before you can exit Omnisense 5 12
162. nlight ral Enter Old Password Enter New Password Reenter New Password OK or Cancel v Enter the default Omnisense password in the top field your chosen new password in the next field and again in the last field Click OK to confirm Use the above procedure whenever a change of password is required Passwords may be changed only by the user to whom the password belongs To help you get started quickly the next section describes how 4 22 Sunlight Omnisense 7000S 8000S 4 9 Adding Users to add additional user IDs For complete details on administra tion using the Omnisense system user status passwords and access to patient information see Chapter 10 System Admin istration page 10 1 Adding Users Omnisense recognizes two types of users in addition to the System Administrator physicians and operators The two types are distinguished by the privileges they have Operators may conduct SOS measurements on the patients of physicians for whom they work Physicians can change the status of opera tors to allow them to conduct SOS measurements for their patients operators cannot change their own status Also physi cians can add other physicians or operators as users while oper ators can add only additional operators All users must enter their own passwords using Change Password as described above after being added to the User List Adding users is straightforward as described below For full
163. nse first set the Site Selection window to a system site that is closest to the type of site you want to define You can choose an arbitrary site however you can avoid entering some of the parameters if you know of a site that is similar to what you want Select Copy Site from the Research menu The Site definition screen is displayed User Guide 17 3 CHAPTER 17 Research Mode Figure 17 2 Edit site dialog box Research gt Copy Site A Site Design 505 type C Minimum Min SOS m s 2700 Measurement range Max 505 m s a700 C Average No of Points 300 Maximum Max tilt angle 5 0 Site affiliations M System Site I Pediatric T Bone Age l PREMIER Cancel or OK v Enter parameters as required The field functions are detailed in 17 4 Sunlight Omnisense 7000S 8000S Working with User Sites the table below Table 17 2 Site Design parameters Screen feature Function Browse Use this button to search for an image file that button represents your skeletal site The image will be displayed whenever the site is selected on the main screen Site Upon copying a site a new name is automati name cally created the original system site name with N appended to distinguish it as a User site You can change the name to anything you wish simply type the new name in the Site Name field The chosen name will appear in the Site Selection drop down list Probe Enter the
164. nsmission with the Omnisense probe Transmitter Receiver Soft Tissue Bone Signal Path As seen in the figure sound waves are propagated in all direc tions from the transmitting transducer Every molecule in the medium acts as a new transmitter thus propagating the signal again in all directions It follows that there are many paths that the signal can follow from transmitter to receiver Omnisense derives useful information from this scenario by detecting the first signal to arrive at the receiving transducer The path of this signal is determined by Snell s Law upon entering the bone the signal is refracted through a critical angle which is a function of the ratio of speed of sound in soft tissue versus speed of sound in bone it propagates along the bone and then scatters out of the User Guide 3 3 CHAPTER 3 3 3 Introducing Sunlight Omnisense 7000S 8000S bone at the same critical angle The time taken by the signal to travel between the points a and b is the parameter measured by Omnisense Proprietary techniques subtract the time during which the signal travels through soft tissue The Primary Care Unit Omnisense 7000 is a table top unit that may be carried from room to room without difficulty and Omnisense 8000 is designed for mobility Probes are hand held and applied directly to the patient s skin Operation of the unit is completely straightforward SOS measurements take a few minutes
165. nt is now open For a new patient create a new patient record For more information on opening and creating patient files see Opening a Patient File chapter 7 After a patient file has been opened the Measure ment button on the toolbar becomes active next step CHAPTER 8 Patient SOS Measurement Figure 8 1 Opening a patient file Measurement Type gt Single Site A New Site selection Patient Sunlight Omnisense Adults button EO Measure Administration Research Help Select Site site X 1 DISTAL RADIUS Probe J CM measure PANAMA Measurement ment type PatientID Family Name Cycle ja of 5 Elapsed Time 0 12 patient First Name button Date of Bith 7 Gender r Height T Weight E BMI De Close Patient Vv STEP 3 Start Measurement For the first SOS measurement of the day click on the Measurement toolbar button or selecting the Measure menu header If you have not yet per formed a System Quality Verification Omnisense will warn you with the following dialog box Figure 8 2 SQV warning dialog box Probe quality was not verified f Quality verification recommended Perform the SQV procedure as soon as possible Sunlight Omnisense 7000S 8000S 8 4 Locating the Measurement Site STEP 4 sured Site Selection list bad x x 8 5 1 DISTAL RADIUS be 1 DISTAL RADIUS 2 PROXIMAL PHALANX III 3 METATARSAL V
166. nter User Name Enter Password go OK v Following the initial creation of the user ID no password has yet been assigned Enter the ID in the first field and click OK Leave the password field blank Immediately upon entering the application click Administra tion gt List of Users to open the List of Users screen to set a pass word as illustrated next 4 28 Sunlight Omnisense 7000S 8000S Additional Applications Figure 4 20 Setting a new password with the List of Users screen Administration gt List of Users A User List x Physician Name Operator Name Add Amenda Add Jerry O Amy Au 4 OK Smith Jerry M Rose O Smith Remove Remove DaApply Associate _ Current user sunlight Change password 4 14 OK or Cancel A Click on the Change Password button the Change Password dialog box is displayed Since there is no previous password leave the first field blank Enter your chosen password in the second field press TAB and enter it again in the last field Click OK and you are done Please note that any new password may be used to enter any Sunlight application installed on your device Additional Applications A number of additional applications are available with the Sun light device For more information contact your distributor For technical details about adding additional applications to your Sunlight device please see Chapter 11 The S
167. nter socket 10 Printer output in the fig ure Connect the foot pedal to the main unit by inserting its connector into the foot pedal socket 13 Foot pedal socket COM1 in the figure Important safeguards notices for printer or other peripheral equipment installation 1 All the equipment connected to Sunlight Omnisense shall be certified according to standard IEC601 1 UL2601 IEC950 or other IEC ISO standards or equivalent applica ble to the equipment 2 When Sunlight Omnisense is used together with other equipment in the patient area the equipment shall be either powered by an isolation transformer or connected via an User Guide 4 13 CHAPTER 4 Initial Setup additional protective earth terminal to system ground unless it is certified according to standard IEC601 1or UL2601 or equivalent safety standard 3 The leakage current could increase when connected to other equipment STEP 3 Connect Probes Probes should be attached to the unit during initial setup and left connected at all times After initial setup probes are connected disconnected only when adding new probes or transporting Omnisense The correct procedure for connecting probes is illustrated in the following photograph Figure 4 9 Pins on a probe connector Note carefully the arrangement of pins on the probe connector Ensure that you insert the connector into a probe socket so that corresponding pins are aligned Probes may
168. ntom it is important to remove any air bubbles which may be trapped between them This is straightforward the phantom is transparent and you can easily check for such bubbles by visual inspec tion Figure 6 4 illustrates the orientation of the probe phantom combination for doing the visual inspection Figure 6 4 Inspect the contact between probe and phantom visually to insure no air bubbles are trapped there Visual inspection of contact between probe and phantom To remove air bubbles simply press the phantom against the probe and move the phantom around in a short circular motion without lifting it from the probe 6 6 Sunlight Omnisense 7000S 8000S Performing System Quality Verification STEP 9 Execute the measurement Press the foot pedal to begin measuring SOS An audible tone is heard during the measurement indi cating that a proper acoustic signal is being detected Hold the probe vertically with the phan tom set on top of it do not touch the phantom throughout the measurement Avoid any movement The signal being received may be represented by the display of a graph building on the screen from left to right as seen in Figure 6 5 Ifno graph build is displayed the Show Measurement Profile option has been set off To turn it on select Administra tion gt Options gt Settings and click in the appropriate checkbox For measurement at skeletal sites Sun light recommends the option be set off so that o
169. o check the integrity of removable media such as diskettes and Zip disks 16 16 Sunlight Omnisense 7000S 8000S Disk Utilities Field How to enter Type of test The Standard scan is a software check It goes through all directories and files and checks for consistency The Thorough scan includes a check of the physical surface of the drive It takes longer but is more reliable Automati You should normally check this option cally fix errors Disk Compress This facility is also known as defragmenting a disk When you modify a file and it becomes longer the operating system may allocate the additional space in a different part of the disk than the original file After a period of consistent use files on your hard disk become fragmented as a result Omnisense needs more time to access a heavily fragmented file structure and eventually this additional time may become inconvenient Heavily fragmented files are also more subject to corruption Use the defragmentation facility at regular intervals to keep your software performing as it should Click Administration gt Repair Tools gt Disk Compress The Disk Compress dialog box is displayed User Guide 16 17 CHAPTER 16 Utilities and Peripherals Figure 16 8 Disk Defragmenter dialog box Administration gt Repair Tools gt Disk Compress A Disk Defragmente J Fie Action View Help e mR Estimated disk usage before defragmentation
170. o the main unit by inserting its connector into the foot pedal socket 9 Foot pedal socket COM1 in the figure Important safeguards notices for printer or other peripheral equipment installation 1 All the equipment connected to Sunlight Omnisense shall be certified according to standard IEC 60601 1 UL2601 IEC950 or other IEC ISO standards or equivalent applica ble to the equipment 2 When Sunlight Omnisense is used together with other equipment in the patient area the equipment shall be pow ered by an isolation transformer unless it is certified accord ing to standard IEC 60601 lor UL2601 or equivalent safety standard 3 The leakage current could increase when connected to other equipment STEP 3 Connect Probes Probes should be attached to the unit during initial setup User Guide 4 17 CHAPTER 4 Initial Setup Note carefully the arrangement of pins on the probe connector as seen in Figure 4 9 Pins on a probe connector page 4 14 Ensure that you insert the connector into a probe socket seen in Figure 4 10 Probe slots on Omnisense 8000 page 4 18 so that corresponding pins are aligned Probes may be inserted into either of the two sockets at the back of the device Press the connector firmly into its socket Tighten the locking screws as this ensures proper electrical ground Repeat this procedure for the second probe and tighten locking screws Figure 4 10 Probe slots on Omnisense
171. of Contents The list below gives a brief description of the contents of each chapter in this Guide This is followed with suggestions and recommended order of reading the material for different pur poses The Omnisense system provides on line help which has the same structure as this Guide To enter Help choose Help gt Help Topics from the menu bar The following screen will be displayed Please note that Help is not available in all languages When a device is configured for a language in which a Help program is not available for Omnisense the English Help will be displayed instead Cn 5 x Sunlight Omnisense 7000S 8000S m Essential Prescribing Information Introducing Sunlight Omnisense 7000S Initial Setup m Working with Omnisense E System Quality Verification cca Opening a Patient File m Patient SOS Measurement Gj Interpreting the Results of a Measureme ir System Administration Cleaning and Disinfecting Omnisense System Specifications Site Measurement Methodologies Utilities and Peripherals Gy Research Mode a E Keyboard Shortcuts User Guide 1 1 CHAPTER 1 Using this Guide CHAPTER 1 Using this Guide Chapter summaries recommended reading order and con ventions used throughout this Guide CHAPTER 2 Essential Prescribing Information Essential prescribing information compliance with stan dards CHAPTER 3 Introducing Sunlig
172. ollow the instructions provided by the manufacturer of the towelettes If a probe cap is used the following procedure should be performed 1 Apply Parker Gel to the probe surface 8 17 User Guide CHAPTER 8 Sunlight hand rest used when measuring SOS at the Distal 1 3 Radius At right the hand rest is shown being used to position the patient Patient SOS Measurement STEP 4 2 Mount the probe cap and make sure the cap s front skin is in good contact with the Parker Gel and no air bubbles show 3 Another layer of Parker Gel should be placed over the probe cap see step 5 Position the arm To conduct the measurement rest the patient s fore arm on the desktop the arm relaxed and the palm extended but still relaxed and perpendicular to the desk surface when the palmar side is opposite the operator Support the lateral edge of the palm with the hand rest supplied with Omnisense Figure 8 8 As a precautionary measure exam paper should be placed under the patient s hand covering the table and the hand rest to provide a physical barrier against possible soiling or contamination Exam paper should be discarded after every single patient measurement Do not place the palmar or dorsal surfaces of the hand on the rest only the lateral sur face is supported Figure 8 8 Hand rest and correct patient positioning op Surlight Sunlight Omnisense 7000S 8000S 8 18 Cover the region to be scanne
173. omn pa per paoe pa peo poo72004 frae red D a a tit Wa S808 Difference m s sal SOS Current SOS result T Norm Expected SOS result 03 07 2003 09 07 2004 Diff Difference between current and expected result 15 08 2003 11 17 29 Change Measurement Type or switch to Measure v SQV history results may be viewed even if no probe is con nected to the system To do so set Measurement Type to Sys tem Quality Verification and then select Show History from the toolbar or from the Patient menu as above The screen seen in Figure 10 16 SQV choose probe window page 10 24 will appear Choose the desired probe and click OK to see the Probe Quality History screen User Guide 10 23 CHAPTER 10 System Administration Figure 10 16 SQV choose probe window x There is no probe connected to this slot To view ald SQ results choose probe from the list and press OK or Cancel to exit List of Probes BY 008 Z 10 6 Changing Site Order The Site drop down list contains four skeletal sites The radius which is the first site on the list appears as the default for a new SOS measurement You can arrange the sites so that they appear in a more convenient order and change the default with the Site Order dialog window Select Administration gt Site Order to display this dialog box 10 24 Sunlight Omnisense 7000S 8000S Changing Site Order Figure 10 17 Site Order dialo
174. or SOS in m sec 2 2 Sunlight Omnisense 7000S 8000S 2 3 2 4 Contraindications propagating along bones such as the distal one third of the radius the proximal third phalanx the fifth metatarsal and the mid shaft tibia SOS provides a measure of skeletal fragility The output is also expressed as a T score a Z score and a Patient Risk Assessment Index When more than one bone is measured Omnisense may reports an index combining the indi vidual SOS results ORI osteoporotic risk index The results can be used in conjunction with other clinical risk fac tors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and ultimately in the determination of fracture risk The SOS measured by Omnisense has a precision error low enough in comparison with the expected annual change in a patient s measurement to make it suitable for monitoring bone changes which occur in the early years following menopause i e age range approximately 50 65 years Contraindications None known Warnings e Never attempt to operate the Omnisense unit if it is plugged into an outlet that does not meet all electrical code require ments e Make sure that there is proper grounding in the wall outlet e Omnisense is not suitable for use in the presence of a flam mable anesthetic mixture containing air oxygen or nitrous oxide User Guide 2 3 CHAPTER 2 Essentia
175. orrect acoustic contact with the area being scanned CHAPTER 8 8 4 Understanding the Omnisense Measurement Screen on page 8 9 Measure Before viewing results a measurement ment Result must be repeated at least three times with statistically consistent results Each iteration of measurement is called a Measurement Cycle The final Measure ment Result is an averaging of the results of three consistent measurement cycles CHAPTER 8 8 4 Understanding the Omnisense Measurement Screen on page 8 9 When a measurement has been suc cessfully completed the Result button becomes active and you can view the Measurement Result screen CHAPTER 9 9 1 Viewing Measurement Results on page 9 1 Results can also be printed Measure A patient s SOS measurement history ment History may be viewed whenever the patient s file is open 9 4 Measurement History page 9 16 Click on the Measurement History toolbar button History informa tion can also be printed User Guide 5 5 CHAPTER 5 Working with Omnisense The next table describes the key Management operations Table 5 2 Management operations Management Operations Function Enabling Manage ment opera tions Description Management operations are available by default when you first enter the Omnisense system However once you have opened a patient file or started a measurement certain Management operations are no longer available
176. other foreign matter into the probe Do not expose the SQV phantom and the monitor screen to direct sunlight 2 4 Sunlight Omnisense 7000S 8000S 2 6 2 7 2 7 1 Adverse Events e When conducting the System Quality Verification proce dure avoid touching the temperature indication strip on the phantom with the fingers as this affects the phantom tem perature reading required for correct interpretation of the procedure results e When conducting System Quality Verification be sure that no air bubbles are trapped in the gel between the phantom and probe as this affects the acoustic contact of the probe with the phantom e Refer all service problems to qualified Sunlight representa tive only e Monitors printers and other interfacing accessories used with the Omnisense Bone Sonometer must meet IEC 601 1 IEC 950 UL 2601 or equivalent safety standards Adverse Events No adverse events were reported in the course of the clinical studies performed in which a total of approximately 4000 sub jects and 1500 children underwent Omnisense measurement There are no known potential adverse effects of Omnisense on health Clinical Studies A variety of clinical studies were performed involving a total of more than 4000 men and women in order to support Omnisense clinical use These studies are briefly summarized below Reference Databases Objective To construct geographically representative databases of mean SOS v
177. ou entered with Change Password remains the Administrator password unless you change it All System Administrator functions require that password Only one Sys tem Administrator is defined Other users have more limited access privileges A user s access level is a function of two parameters the User Type and Associations User Type There are three user types the System Admin istrator physicians and operators eThe System Administrator has the highest level of access There is only one System Administrator Physicians have access to their own patient data and the data of patients not assigned to any particular physician but not the data of other physicians Operators have access only to unassigned patient data However they may be associated with one or more phy sicians as described next Associations An operator may be associated with one or more physicians This association gives the operator access to the physician s patient data This feature supports use of Omnisense by clinic assistants and other non physician per sonnel under the supervision or responsibility of a particu lar physician Associated status is conferred only by physicians The User List dialog window serves as a center for determining user access privileges In this dialog box new users are added or removed and operators are associated or disassociated with physicians Figure 10 1 shows the User List screen User Guide 10 1 CHAPTER
178. p x Last backup April 24 2000 ad Drive A Floppy 1 44 Mb gt Free space Drive A Floppy 1 44 Mb Ca Drive F lomeqa 100 Mb OK or Cancel h rif STEP 2 Set parameters Enter information as indicated The table below explains the meaning of each field 16 10 Sunlight Omnisense 7000S 8000S Backup Restore Table 16 2 Backup dialog box fields Field Last backup Meaning The date of the most recent Backup opera tion Drive STEP 3 Select the drive into which the backup will be written You must insert media with enough free space in the selected drive A 3 5 inch diskette can hold about 1 4 MB a Zip disk will accept up to 100 MB and a CD RW disk holds about 580 MB Backup operations usually require a Zip or CD RW disk To determine how much free space is available on the volume in the selected drive click on the Read button and observe the Free Space field Execute the backup Click OK and the backup operation will begin The process may take a few minutes Store the backup disk in a safe place or better still establish a regular backup schedule and an archive for storing the backup volumes If you have backed up data to a CD RW diskette the diskette will automatically eject from the drive when the procedure is complete If you should need to restore a system find the Backup from the date required usually the most recent one and perform the proced
179. pear when the mouse passes over one of these checkboxes are provided to aid the physician in filling out this information Mea Checkbox used to indicate the limb used for sured measurement Limb SCHEDULING INFORMATION The third tab in the Patient Information form is a measurement scheduling management tool Scheduler see Figure 7 3 which helps the user track down and follow up scheduled measure ments as well as schedule future appointments The scheduling feature includes the following facilities e Automatic scheduling The system schedules the next measurement automatically according to default values set by the user Default scheduling values are entered via the Administration menu under Administration gt Options gt Scheduler and are described in CHAPTER 10 10 2 Setting System Default Options on page 10 6 e Manual scheduling Although the scheduling is set auto matically for all patients according to the default values set by the user the user is free to set any desired measurement date manually using the Scheduler form in the Patient Information dialog box illustrated in Figure 7 3 7 8 Sunlight Omnisense 7000S 8000S Patient Files Tracking patient measurements The system provides the user with a Visit Database list used as a tracking tool This list displays all patients whose next measurement date has to be set or confirmed The list is updated according to current date and patients schedul
180. per ator attention to the site is not distracted by the screen display During measurement an audible tone indicates cor rect acoustic contact If no tone is heard the Mea surement Sound option has been set off To turn it on select Administration gt Options gt Settings and click in the appropriate checkbox User Guide 6 7 CHAPTER 6 System Quality Verification Figure 6 5 Measuring the phantom SOS during SQV Measurement Measurement Type SQV gt Start A Measurement B ES Change Measurement Type or Result or Abort A STEP 10 Repeat for three cycles When the graph reaches the right end of the screen the audible tone stops a distinct beep is heard and the measurement cycle is complete Completion of the measurement cycle is also indicated by the crossed flags icon as seen in Figure 6 6 6 8 Sunlight Omnisense 7000S 8000S Performing System Quality Verification Figure 6 6 SQV measurement cycle completed To insure statistical validity of your result Omnisense requires that the measurement cycle be repeated three times The Cycle indicator shows how many cycles have been completed including the current one Reposition the phantom on the probe and perform the measurement steps 6 9 twice more Add additional ultrasound gel if required After three cycles have been completed the Result button at the lower right of the screen seen at left should become active
181. persion of the SOS measurement results User Guide 2 13 CHAPTER 2 Essential Prescribing Information The in vivo precision of repeated Omnisense measurements in the same subject is also extremely high with a CV of 0 40 0 81 depending on the site In all the sites there were some relative differences in CV between premenopausal and post menopausal subjects Differences in precision between pre menopausal subjects and postmenopausal subjects have been found in DXA measurements postmenopausal CV higher than premenopausal CV as well as in QUS measurements of the calcaneus postmenopausal CV lower than premenopausal CV There were also differences between CVs measured by differ ent operators Nevertheless all CVs were well below 1 indi cating good precision for all subgroups and thus allowing for a meaningful assessment of patient status relative to the reference range For example The mean square error at the Radius about 17m sec is similar in magnitude to the average change per year which is observed during the first years of sharp decline in SOS post menopause This trend is similar at the other sites Thus Omnisense can provide precise estimates of bone status during this important time when bone changes are most pronounced Table 2 6 below follows C Gluer in assessing trend assessment intervals for follow up when large changes are expected such as after commencement of specific intervention or assessing
182. plication option on the opening screen of the application software and follow the instructions on the screen If you wish to remove a pre installed application from the Sunlight Desktop please contact Sunlight Customer Support at support sunlightnet com to receive a disk with the required files and proceed as above Please note that the removal of an application can be carried out only if the manufacturer of the application has permitted the removal procedure through its installation package Desktop Utilities Default Start up Options Omnisense devices on which the Sunlight Desktop is installed begin with the Sunlight Desktop screen upon start up This option may be changed so that the device begins with the Omnisense start up screen upon start up To change your default start up option click Options gt Default Start up You will be asked to choose either Omnisense or Sun light Desktop as your default start up option Choose one of the two and click OK Even if the chosen default start up option is Omnisense you can exit Omnisense to the Sunlight Desktop by selecting Exit to User Guide 11 5 CHAPTER 11 gt The Sunlight Desktop Desktop when exiting Omnisense through Patient gt Exit User Interface Language The default user interface language of the Sunlight Desktop is English Changing the User Interface Language STEP 1 Change Language To change the user interface language click Options gt User In
183. plied and whether statutory or otherwise including but not limited to any implied warranty of merchantability or fitness for a particular purpose The remedies herein contained are the sole and exclusive remedies of the customer This warranty gives the customer specific legal rights but appli cable local laws may provide additional legal rights or prohibit certain terms or conditions of this warranty Any provision of this warranty that is prohibited by local law is therefore null and void Vil D Warranty Card Purchaser s Name Purchaser s Address Distributor s Name and Address Sunlight Omnisense 7000S 8000S Model Serial Number Ultrasound Probe s Type Serial Number Type Serial Number Type Serial Number Date of Purchase Name Signature viii END USER LICENSE AGREEMENT The Distributor shall be entitled to provide separate and additional warranty terms respecting the Product but shall not be authorized to bind Sunlight to such additional terms and shall indemnify Sunlight against any such liability The Distributor s standard End User License Agreement will include the fol lowing provisions Purchase of the Product shall entitle the End User to a personal non transferable non assignable non exclusive and limited rights to use the software component of the Product the License and the Software respectively The Product is licensed as a single product The End
184. position the limb during SOS measurement Software upgrades may also be used to extend or add reference databases and for the installation of new features System Upgrade is found under the Administration menu Cur rently two types of System Upgrade are supported Site upgrade and Software Version upgrade The information below describes the first type a Software Upgrade from Sunlight will be provided with complete instructions for installation User Guide 16 23 CHAPTER 16 Utilities and Peripherals Site Upgrade Select Administration gt System Upgrade and the following dia log box will appear Figure 16 11 System upgrade initial dialog box Administration gt System Upgrade A Omnisense upgrade l Insert 1st Upgrade disk and press OK or press Cancel OK or Cancel v Omnisense will determine the type of upgrade directly from the media you insert in the drive In the case of a Site Upgrade disk the following dialog box will appear next 16 24 Sunlight Omnisense 7000S 8000S System Upgrade Figure 16 12 Site update dialog box Administration gt System Upgrade gt OK A Import Site s data Ea Cz a hit la a a a a OK or Cancel v User Guide 16 25 CHAPTER 16 Utilities and Peripherals Available sites will be listed in the left window along with ref erence databases which you can add or upgrade To add or upgrade sites select them from the list by clicking with
185. r to print an encrypted report and send it to the local regional Support Center by fax or e mail and then await further instructions e Ifthe failure requires the presence of a technician the mes sage advises the user to call the local regional Technical Service office Logger Export The user may download the logger by selecting Administra tion gt Service gt Export Log in the Administration menu The fig ure below shows the location of the Logger Export function in the menu in order to save the logger on a diskette 16 22 Sunlight Omnisense 7000S 8000S 16 8 System Upgrade Figure 16 10 Export procedure saving the logger on a diskette Administration gt Service gt Export Log A Sunlight Omnisense Adults Patient Measure Administration Research Help Backup Ctrl B Restore Ctrl R List of Users Patient Management License Status Visit Scheduler Print Setup Repair Tools gt Format Diskette Eject CD R Export Log file System Upgrade Site Order Options Application System Upgrade One of Omnisense s advantages is that when new skeletal sites become available the capability for measuring SOS at these sites can easily be added to the system with a simple software upgrade You need only add the appropriate skeletal site kit which may include a probe measurement accessories for pre cisely locating the site and fixtures to
186. rement have been completed Results are shown plotted against reference ranges Measurement History Patient History may be viewed in any mode for the current patient 5 2 Sunlight Omnisense 7000S 8000S Basic Operations Omnisense Management Mode Omnisense Management Mode Management mode is for all functions not directly related to SOS measurement These include setting various default parameters user security patient management and various utilities for storage and backup Patient History may be viewed from both Management Mode and Measurement Mode View Measurement Data Open Close Edit Delete Patient Show Patient History Measurement Mode Print To enter Measurement Mode a patient file must be open or the Measurement Type must be set to System Quality Verification Sunlight Omnisense Adults Patient Measure Administration Research Help y Opens a new patient Patient Utilities Goes to measurement mode Import Patient Data Export Patient Data Opens patient measurement history Prints results Displays an instructional video Utilities on measurement method Backup Restore Tracks down scheduled License Status measurements Print Setup Scan Disk Disk Compress Database Clear Printer Queue System Administration Format Diskette List of Users Patient Management Visit Scheduler Service System Upgrade S
187. ribes the procedure Select Skele Choose a site where SOS is to be mea tal Site also sured a Measure Site selection is available whether or not ment opera a patient file is open tion Open Close Only one patient file may be open at a Patient also time a Measure A patient file must be open to conduct ment opera bone SOS measurements as well as to tion view or edit any data associated with that patient User Guide 5 7 CHAPTER 5 Working with Omnisense Management Operations Function Toolbar Description The toolbar is visible at all times and pro vides quick access to the most com monly needed functions All toolbar functions are also available from the menus as described next See the graphical overview at the beginning of this chapter for a description of the tool bar functions Patient func tions These functions are found under the Patient menu New Open Edit Delete Close Displays a new patient form or an existing one for data entry or modifi cation Chapter 7 Opening a Patient File An open patient file can be deleted from the patient database Show History Displays all SOS measurement results for the current patient Measurement History on page 9 11 5 8 Sunlight Omnisense 7000S 8000S Print Prints the patients SOS measurement history or a Patient Schedule Report whichever is currently open Import Export This facility allow
188. rrect location Omnisense is shipped with one or two measuring gauges Their use is described in 8 5 Measur ing SOS at the Radius page 8 16 and in Chapter 14 Site Measurement Methodologies page 14 1 The gauges are illus trated in the photographs below Figure 4 8 Measuring gauges The phantom see Figure 4 6 Phantom for system quality ver ification page 4 10 limb positioning fixtures see Figure 4 7 Limb positioning fixtures page 4 11 and measurement gauges see Figure 4 8 Measuring gauges page 4 11 are used both for Omnisense 7000S and Omnisense 8000S User Guide 4 11 CHAPTER 4 4 5 4 5 1 Initial Setup Cable Connections The Omnisense system is designed for easy set up Once you have determined that you have all the necessary parts follow the procedure below Cable Connections for Omnisense 7000S Unit Setup Procedure STEP 1 STEP 2 Position the Omnisense Unit Place the main Omnisense unit on the surface where it will be operated Ensure that it is within reach of a standard electrical outlet and that it is well away from any source of heat or air conditioning Ensure also that there is room for patient and operator chairs near the unit and that sufficient desk or table space is available for a patient to rest an arm com fortably Attach Rear Panel Connector Cables Insert each component connector securely into the corresponding socket and tighten the screws if required
189. rs change to flag icons indicating successful completion The anatomical picture is replaced by a graph of the SOS values recorded Sampling Repeat the procedure for a measurement cycle at completed least three times or until the Result button at the bottom right of the screen becomes active Each completed cycle will be indicated by an advance of BE the Cycle indicator at the top of the screen If you have completed five cycles and the Result button is still greyed out this means that the results of your measurement cycles have too much variability Be Click Abort and select Abort all from the options offered and try the cycle sequence again If the methodology is being followed correctly this will rarely happen When three consistent cycles have been completed you can click on the Result button to view the results of the measurement Results are explained in Chapter 9 Interpreting the Results of a Measure ment 8 22 User Guide Interpreting the Results of a 9 1 Measurement Viewing Measurement Results Measurement Results Upon successful completion of a measurement clicking on Result or simply pressing Enter takes you to the Measurement Result screen as illustrated in Figure 9 1 The right side of the screen displays a graph On the left side of the window below Patient Information a group of statistics summarizes the mea surement results Figure 9 1 SOS measurement result screen Measurement g
190. rs of age and fracture subjects were not taking medications having a pos itive effect on bone metabolism Results Table 2 3 contains a summary of SOS results for each study group for each of the skeletal sites measured Non frac tured group and fractured group were age matched All SOS differences between the three fractures groups and the non frac ture group were statistically significant p lt 0 01 User Guide 2 9 CHAPTER 2 Essential Prescribing Information Table 2 3 SOS Results by Study Group and Skeletal Site Vertebral Wrist Frac Fracture ture Non Fracture Hip Fracture Radius SOS Mean SD 38734154 38774144 38804154 39534138 T Score lt 2 5 59 48 55 46 T Score gt 1 0 9 10 10 21 Tibia SOS Mean SD 3700 219 37094194 3740 188 3766 156 T Score lt 2 5 46 46 33 43 T Score gt 1 0 33 28 36 33 Metatarsal SOS Mean SD 31434175 32124227 32574242 33694464 T Score lt 2 5 43 48 27 16 T Score gt 1 0 9 10 14 36 Phalanx SOS Mean SD 35964175 36364150 36624152 37394184 T Score lt 2 5 68 60 48 35 T Score gt 1 0 4 5 6 19 Logistic regression for fracture discrimination indicates that the area under the ROC curve unadjusted for age is 0 63 95 CI 0 56 0 70 for the Radius with the largest AUC value found for the Metatarsal Table 2 4 contains the
191. s Temperature 0 to 50 C portation condi 32 122 F tions Humidity 10 to 90 non con densing Main Unit Dimen Ww H D sion 39 cm x 13 cm x 33 cm 15 x P x 13 not including probe holder Main Unit Weight Approximately 7 kg 15 Ib Printers Standard PC printers Recommended printer list appears on the Sunlight website at http www sunlightmedical com Interna tional html printers html Additional printers may be added with the Add Printer utility on the Sunlight Desktop see Printers on page 11 9 Backup Platforms Zip drive 100 MB diskettes or CD RW drive approx 580 MB depending on model 3 5 drive 1 44 MB User Guide 14 3 CHAPTER 14 System Specifications 14 2 2 Technical Specifications for 8000S Table 14 1 Omnisense 8000S device specifications Parameter Specification Measurement Speed of Sound SOS Technology Ultrasound Omnipath Axial Transmission Probes Proprietary multi transducer probe family Center frequency 1 25 MHz Measurement RMS CV 0 4 to 0 8 in vivo Precision amp Accu racy Measurement Time precision depending on site 0 25 to 0 5 instrumental accu racy depending on probe Approximately 1 minute per skele tal site User Interface Convenient keyboard and integrated mouse Calibration Calibration free Daily System Quality Verification procedure with phantom is recommended Display 12 1 T
192. s an osteoporotic condition according to the crite ria adopted by the World Health Organization WHO Although the WHO criteria may serve as a useful starting point the interpretation of any ultrasound result in the context of bone status assessment should carefully consider a range of risk fac tors which may impact its significance These include age pre vious fractures frame size smoking habits etc Displayed at the left of the screen below patient information are two types of statistical information derived from the basic SOS value Additional information the Patient Risk Assessment Index appears in the Details section for each measurement Table 9 1 explains the meaning of the basic statistical informa tion and Patient Risk Assessment page 9 7 describes the Patient Risk Assessment process 9 2 Sunlight Omnisense 7000S 8000S Viewing Measurement Results Table 9 1 SOS statistical measures Measure Meaning T score This measure is most directly applicable to patient risk assessment The T score relates an SOS value to the scores obtained for young healthy adults The T score value is the number of stan dard deviations by which the current patient s SOS value exceeds or falls below the mean of this young adult group Z score A Z score relates the SOS value to an age matched database of the same sex and eth nic origin as the patient The Z score value is the number of standard deviations by which the
193. s before use with tion tow each patient Towelettes approved for use elettes with Omnisense are described in chapter 11 Skin For marking the scan location marker Stationary All SOS measurements are conducted with chair the patient seated The chair should be sturdy comfortable and without wheels or other movability In addition to the above items the following are required for measuring at specific skeletal sites CHAPTER 8 Patient SOS Measurement Table 8 13 Site specific items for use with Omnisense Site Item s required Radius Radius gauge for measuring the limb to locate the scan site supplied with the rel evant skeletal site kits Distal 1 3 Hand rest for positioning the arm during Radius only scanning supplied with the relevant skel etal site kit A desk or table to provide stable support for the arm during measurement and scanning Metatarsal Leg rest to support the leg during scan ning not supplied Phalanx L gauge for measuring the limb to locate Metatarsal the scan site supplied with the relevant skeletal site kit There are three overall steps involved in an SOS measurement readying Omnisense locating the site and scanning the bone After a short time you will find yourself completing the entire process in a few minutes Nevertheless it is essential that SOS measurement be conducted exactly as described here particu larly locating the site and performing the sca
194. s by Site Each line in the file represents one measurement e Measurements by Patient Each line in the file represents the last measurement of a patient in all measurement sites Measurements by Site is more suitable for site development precision studies or longitudinal follow up while Measurement by Patient is more suitable for clinical cross sectional studies Measurements by Site Measurements are sorted by patient date and site Each line represents one measurement Multiple measurements 16 6 Sunlight Omnisense 7000S 8000S Data Conversion performed on the same patient on the same date will be pre sented in one line per measurement even if it includes several measurements of the same site The file contains the following list of columns in the following order Column headings are printed at the first line Empty fields are marked N A List of columns in the by Measurement file 1 2 3 4 13 14 Measurements by Patient PATCODE FAMILY NAME VISITDA BIRTHDA SEX HEIGHT WEIGHT SYSTEM SITE PROBE SOS P95 SOS AVERAGE SOS P25 Patient ID Last name family name First name Measurement Date according to regional set tings e g DD MM YY Date of Birth according to regional settings e g DD MM YY Gender Height cm Weight kg Omnisense S N Skeletal Site Probe Type and S N Max SOS value 95th per centile Average SOS value Min SOS value
195. s moving patient data between Omnisense systems CHAP TER 15 15 1 Import and Export of Patient Data on page 15 1 Basic Operations Management Operations Function Description Administra These are found under the Administra tion Func tion menu tions Utilities Backup Restore Two utilities to support archiving of patient data and security CHAPTER 15 15 3 Backup Restore on page 15 10 Omnisense has a built in Zip drive for 7000S or CD RW drive for 8000S for backup of large amounts of data List of Users This dialog box is used to add remove users set change passwords and associate operators with physicians CHAPTER 10 10 1 User Access Levels on page 10 1 License Status This utility enables monitoring of license type and status extending Pay Per Scan license ordering new scans and upgrading licenses These operations are performed through cus tomer support Visit Scheduler This dialog box is used to help the user track down and follow up sched uled measurements appointments User Guide 5 9 CHAPTER 5 Working with Omnisense Management Operations Function 5 10 Sunlight Omnisense 7000S 8000S Description Print setup Use this to configure a printer for Omnisense 15 4 Print Setup page 15 14 Repair Tools The repair tools provided include utili ties to scan a disk for errors compress a disk repair the database and clear the printer q
196. same bone in the contra lateral limb or carry out a new measurement of the same site Figure 9 2 Suggest to re measure pop up box The measurement result is considered exceptional It is recommended to repeat the measurement to certify the result Before leaving the measurement result screen you must decide what should be done with the result of the measurement Nor mally you will want to save the data as part of the patient his tory On occasion you may wish to discard the result and repeat the measurement These options are provided by two buttons at the bottom right of the screen as detailed in Table 9 2 Table 9 2 Exit options for Result screen Button Function Abort Discards the currently displayed result A warning dialog window appears first ask ing if you are sure you wish to discard the data Save and Records the current result with the patient s Close measurement history and returns you to the Measurement screen 9 4 Sunlight Omnisense 7000S 8000S Viewing Measurement Results If you abort the current result Omnisense will first warn you Figure 9 3 Warning before discarding measurement result Are you sure you want to abort last measurements and return to main menu Use the Print icon on the toolbar to print a hard copy of the result for your patient your own records or for a referring physician To set up your printer see Print Setup p
197. seen in the figure The SQV procedure is described next User Guide 6 3 CHAPTER 6 Q System Quality Verification System Quality Verification Procedure STEP 1 STEP 2 STEP 3 STEP 4 Power up Omnisense If Omnisense is being powered on for this SQV go through the login procedure by entering your user ID and password Otherwise start with Step 2 Set Measurement Type to SQV Select System Quality Verification from the Mea surement Type drop down list Please note that once this Measurement Type has been chosen patients cannot be added to the device and patient files cannot be opened If you try to add a new patient to the patient list or open a patient file the measurement type will automatically revert to Sin gle Site Choose the probe to be verified On the screen shown above click in the Slot selec tion box and select the probe that you want to ver ify Slot refers to the socket on the rear panel in which the probe connector is inserted In the exam ple below 2 CM indicates that Slot 1 is selected and that a type CM probe is currently connected in that slot Slot 4 2 Ch Start Measurement Mode On the Omnisense screen enter Measurement Mode by pressing the toolbar Measurement button or by clicking on the Measure menu header 6 4 Sunlight Omnisense 7000S 8000S Performing System Quality Verification STEP 5 Read temperature conversion factor The phantom has an
198. sound 3 1 3 2 Omnisense Technology Omnipath 3 2 3 3 Relationship between Omnisense Results and Risk of Fracture3 4 xi xii 4 Initial Setup 4 1 4 1 Examination Room Environment 4 1 4 2 Unpacking Omnisense 4 2 4 3 Identifying System Components 4 4 4 4 Measurement Accessories 4 10 4 5 Cable Connections 00005 4 12 4 6 Power On the System ssssananna 4 19 4 7 Initial System Access 00005 4 19 4 8 Changing the System Password 4 21 4 9 Adding Users 200ce eee 4 23 4 10 The Sunlight Desktop 4 24 4 11 Setting the System Time 4 25 4 12 Setting System Default Options 4 27 4 13 New User Entry 00 cease 4 27 4 14 Additional Applications 4 29 5 Working with Omnisense 5 1 5 1 Basic Operations 2022005 5 1 5 2 Changing Users and Shutdown 5 12 6 System Quality Verification 6 1 6 1 About System Quality Verification 6 1 6 2 Performing System Quality Verification 6 2 7 Patient Files 7 1 7 41 Patient Files 1 20025 edwt ine et iecle ses 4 7 1 7 2 Opening a Patient File 7 14 7 3 Measurement Comments 7 17 7 4 Deleting a Patient File 7 17 7 5 Tracking Down a Patient s Measurements 7 19 8 Patient SOS Measurement 8 1 8 1 8 2 8 3 8 4
199. st save the results in the Multi Site Measurement screen Then open the Measurement History of the patient for whom you want to delete a measurement in Single Site mode for the site for which you wish to delete the measurement and delete the measurement as described above Figure 9 7 Patient measurement delete measurement result Patient Measure Administration Research R amp D Help PE EPS Probes Measurement Type E Single Site X Site 1 DISTAL RADIUS z Probe CM Patient Information Measurement History Patient ID 3344 k Family Name Sead 5 304 4463 First Name Elaine n Previous value 204 Curent value pace Measurement Data p Patient Measurements f 4267 Date SOS T Score Z Score oa see 22 21 I eoo 3097 28 26 Delete Selected Measurement ES eE 3973 a B paspulpunog jo paadg 4071 g E 5 a T Score Number of standard deviations from i the mean of normal young adults Fe a oe eae acre rs rs he 20 25 30 35 40 45 50 55 60 65 70 75 80 85 2 Score Number of standard deviations from Agelyears the mean of age matched population 17 07 2003 12 16 34 Please note that deleted measurements are not recoverable Multi Site Measurements Omnisense provides a unique capability among quantitative ultrasound systems in that it supports measurements at multiple User Guide 9 9 CH
200. sure increase or decrease or ethylene oxide EtO gas 12 4 Sunlight Omnisense 7000S 8000S oN seer Troubleshooting This section lists potential problems that users of Omnisense may encounter together with typical causes of the problem and the appropriate action to take Table 13 1 Potential problems and suggested solutions Problem The Omnisense oper ation power indicator is not illuminated for Omnisense 7000S only Possible Solution Check that the AC power cable is connected properly at both ends Check that the main switch on the front panel is in the On position Check the control unit fuses to make sure they are not damaged or burned If necessary replace the fuses The Omnisense oper ation power indicator is illuminated but the screen is dark for Omnisense 7000S only Ensure that the monitor s power cable is correctly plugged in to the monitor and to the main Omnisense unit at the back panel LCD or to the isolation trans former which is properly con nected to a wall outlet CRT In the latter case check the fuses of the isolation transformer Check the monitor brightness and con trast controls Check that all device connections conform to the installation instruc tions in this Guide User Guide 13 1 CHAPTER 13 Troubleshooting Problem Measurement does not start indicators remain red Possible Solution Verify that you are using the cor r
201. t s risk of osteoporotic fracture in a manner similar to that used in X ray absorptiometry In 1994 a Study Group commissioned by the World Health Organization WHO proposed clear guidelines for physicians diagnosing osteoporosis based on T scores a Normal T score above 1 0 b Osteopenia T score between 1 0 and 2 5 c Osteoporosis T score below 2 5 These cut off values related initially to Bone Mineral Density BMD measured at the forearm Nevertheless they were shortly adopted for axial BMD measurements including BMD of the spine and the hip whereby the lowest value reported is usually considered for diagnostic purposes Kanis et al 1994 Omnisense sensitivity and categorization capability was found in various studies to be similar to those of hip and spine BMD and it is therefore suggested that the WHO criteria be adopted and applied to the Omnisense measured T scores The physi cian should of course consider other risk factors such as low body weight fracture history family history corticosteroids use etc in patient evaluation Concerning risk of fracture research shows that the odds ratio of osteoporotic hip fracture to non fracture subjects measured by Omnisense is about 1 5 That means that a decrease of 1 5 T score units corresponds to a 50 increase in the odds of hip fracture while a decrease of about 2 5 T score units doubles the odds of hip fracture 2 22 Sunlight Omnisense 7000S 8000S 2 9
202. t Result A Previous value Current value Abort or Save and Close v User Guide 9 1 CHAPTER 9 Interpreting the Results of a Measurement The absolute value of an SOS measurement has no significance Results are meaningful in relation to a reference database of SOS values taken from a large representative population At the right of the screen a graph of reference SOS values for the current patient s gender and ethnic group is displayed Speed of Sound SOS is plotted as a function of age The thin lines above and below the bold reference curve represent one standard deviation above and below average respectively The SOS value obtained for the current measurement is shown as a purple round dot on the graph with dotted lines extended to show the corresponding points on the horizontal and vertical axes In the example the patient has a Z score result of 0 0 equivalent to a Z score of 0 2 That is the result is equivalent to the mean SOS value for normal young adults and falls 0 2 standard deviations below the line of the mean SOS value for his her age If previous measurements were performed on this patient they will be displayed in the graph as blue round dots The meaning of a particular SOS value requires interpretation based on clinical experience For comparison when measuring bone mineral density BMD with Dual X ray Absorptiometry DXA equipment 2 5 standard deviations below normal young adults reflect
203. t because they take into account both the mean and statisti cal distribution of population reference values Those results together with the patient s clinical profile provide the physician with useful data on which therapeutic decisions can be based Osteoporosis Risk Index ORI Definition Based on Omnisense multi site capability an Osteoporosis Risk Index ORI is calculated and reported for any two skeletal sites It is formed based on the assumption that skeletal sites do con tribute according to their responsiveness to change and specifi cally responsiveness to SOS change with age The assumption is that bone strength deterioration with age is the main skeletal factor to determine risk of fracture and it is reflected directly by the relative change The ORI provides a risk assessment and diagnostic power equal or better than that provided by each of the contributing single sites on the average User Guide 2 21 CHAPTER 2 Essential Prescribing Information Patient Risk Assessment Index Definition The Patient Risk Assessment score estimates the absolute risk that the patient will sustain an osteoporotic fracture over the next ten years in terms of percentage A score of 18 for example indicates that the patient may have an 18 risk of sus taining an osteoporotic fracture over the next ten years Bone Ultrasonometry and Fracture Risk Omnisense reported T scores can be used to assess a patien
204. t cycle start end but tons page 8 13 Metatarsal V Always measure the patient s non dominant side In case of a disorder or impairment in the non dominant limb such as an edema or mass use the contra lateral side instead Positioning the patient 1 The patient is seated in a chair opposite the operator The leg is extended and placed on a leg rest the foot as close to the operator as possible as seen in Figure 15 12 15 12 Sunlight Omnisense 7000S 8000S The toes are flexed downward and together by the patient to make the distal part of the metatarsal V prominent Metatarsal V Figure 15 12 Initial patient position for the metatarsal V Determining the area to be scanned 2 To locate the region of interest instruct the patient to make a fist with their toes i e flex them downward and together so that the distal part of the metatarsal V is prominent Fig ure 15 13 illustrates the correct attitude of the foot Figure 15 13 Patient position prior to marking the ROI User Guide 15 13 CHAPTER 15 Place a single dot at the distal prominence of the metatarsal The L gauge is used for marking of the Region of Interest at the metatar sal The same gauge that is used for the pha lanx Site Measurement Methodologies Figure 15 14 Marking the distal end of metatarsal V With a skin marker place a dot just proximal to the promi nence The dot coincides with the dist
205. t the probe around the marked line on the skin e Check to insure that a scan movement through 140 degrees takes about 4 5 seconds The scan is being conducted too slowly or too quickly if the movement takes longer or shorter respectively than this amount of time e Maintain the probe s surface in contact with the patient s skin throughout the scan No part of the probe surface should be raised from the skin at any point during the scan e During the measurement cycle concentrate on the site and correct application of the probe Avoid looking at the screen Use the audible signal to provide feedback and guide you in correct execution of the scan e If probe caps are used replace the probe cap with every measurement If the measurement is not going well you can restart at any time during the cycle by pressing Restart for the first cycle the button is labeled Start The Foot Pedal is provided to allow hands free operation of Omnisense during a measurement cycle Pressing on the foot pedal is equivalent to clicking on the Start Restart button If Omnisense is not receiving an appropriate signal indicated by an intermittent sound or no sound check that sufficient Parker Gel is on the probe as well as on the area being scanned Measuring SOS at the Radius STEP 8 Complete three measurement cycles When you complete a measurement cycle the Acoustic Signal Acquisition traffic light and Acoustic Contact indicato
206. t value lL 4385 Measurement Statistics p Patient Measurements sea i g Date SOS T Score Z Score oo 4 L 4169 amp p 270237 aoe 09 05 I 2 8 27 02 99 4042 1 3 06 go anag p ermana a02 13 06 a H zaman sae 8 0 i ee te on l l 25 8 3 0 4 3875 E a ee 40 4 3777 T Score Number of standard deviations from merpati mayana sans re aa 2 Score Number of standard deviations from Agelyears the mean of age matched population Close Patient or Measure A 9 16 Sunlight Omnisense 7000S 8000S Measurement History In the table at the left of the screen measurement results are displayed in a format identical to that used in the Result screen 9 1 on page 9 1 The difference is that here the results of all measurements conducted for the current patient are displayed each measurement result is on a separate row If the list is long use the scroll bar to move through the data The graph at the right plots Speed of Sound result data on the vertical axis against the dates of specific measurements on the horizontal axis The resulting curve is indicative of changes over time The thin lines below and above the reference curve represent a range of one standard deviation above and below the age matched reference curve for the current patient s gender and ethnic group The bands in this graph have the same mean ing as do the colored bands in the Result screen Results can be printed in a t
207. tal sites which are provided with the Seo clinical version of Omnisense are also Reference DB provided with the Research version Convert Results These are referred to as System Sites Additional sites created by research ers for their own work are called User Sites Modifications to sites are sup ported only for User Sites An attempt to modify a system site will be denied The menu options provided are as fol lows Edit Site modify the parameters of a user skeletal site Copy site used for creating a new user site First copy a system site or an already defined user site then modify it as desired Delete site User sites may be deleted system sites can not Reference DB supports creation of your own reference database Convert Results supports convert ing result files to a form usable by standard programs such as SAS or Excel 17 2 Sunlight Omnisense 7000S 8000S L722 Working with User Sites Screen feature Function Research Infor At the lower left of the Omnisense mation screen parameters of the currently selected skeletal site are displayed The remainder of this chapter describes each of the Research menu items in more detail Working with User Sites The primary purpose of the Research version is to support bone SOS measurement at new sites being investigated by research ers Creating a User Site To set up a new skeletal site for measuring SOS with Omnise
208. tallation of the Sunlight Desktop requires a software upgrade The procedure is as follows Installing Sunlight Desktop Software Upgrade STEP 1 Begin Installation Process On the Omnisense screen select Administra tion gt System Upgrade A dialog box will request that you insert the upgrade disk and press OK or Cancel User Guide 11 1 CHAPTER 11 11 2 The Sunlight Desktop STEP 2 Insert Upgrade Disk Insert the Sunlight Desktop software upgrade floppy disk or disks and follow the instructions on the screen STEP 3 Set Default Start up Option The default start up option of the device will remain as Omnisense To change the default start up option for the device see Default Start up Options page 11 5 Adding and Removing Applications The Sunlight Desktop is the entry point for use of a number of medical diagnostic applications including both applications produced by Sunlight and applications from other manufactur ers which have been enabled for use with Omnisense Diagnos tic applications for use on the Sunlight Desktop fall into two categories 1 Applications that are pre installed on the Sunlight Desktop and appear as enabled icons on the Sunlight Desktop These applications can be used without further software installa tion once the application hardware is attached to the device These icons automatically appear on the Sunlight Desktop New applications which are not pre installed on the Sunl
209. terface Language Choose the appropriate language by clicking on the name of the appropriate language Click OK The system will now use the chosen user interface language Regional Settings The default regional settings of the Sunlight Desktop are British English settings Regional settings include date and time for mats decimal number formats currency and currency format Changing the Regional Settings STEP 1 Begin Procedure To change the regional settings click Options gt Regional Settings Choose the appropriate regional settings by clicking on the name of the appropriate settings Click OK The system will indicate if it requires a reboot after changing these settings and will reboot automatically if this is required 11 6 Sunlight Omnisense 7000S 8000S Desktop Utilities STEP 2 Complete Procedure A change of the regional settings will affect the Sunlight Desktop and all applications on the Sun light Desktop except for Omnisense The regional settings of Omnisense may be changed only through the Omnisense software Keyboard Language Changing the Keyboard Language STEP 1 Change Keyboard Language The Sunlight Desktop default keyboard language is English To change the keyboard language locate the language button that appears on the upper right hand side of the screen The button shows the keyboard language currently in use If you click on the language button you will see a list of available keyboar
210. th the probe when scanning 11 Press the foot pedal to begin the measurement cycle When the probe is in proper contact with the area to be scanned an audible signal is heard from Omnisense 12 Scan by moving the probe in a direction perpendicular to the long mark for a distance of one to two centimeters in the dorsal direction and then back again to the starting point Repeat this movement continuously until the scan cycle completes Do not move the probe quickly Figure 15 17 Scanning the metatarsal V Hold the probe against the flat surface of the bone and move it ina range of one to two centi meters toward the dorsal side and back repeating until the scan completes 15 16 Sunlight Omnisense 7000S 8000S Metatarsal V To ensure accurate and reproducible results note the following e The probe should be maintained parallel to the Metatarsal bone never diagonal to it e Never hold the probe at an angle to the surface of the limb The probe should be held so that the short dimension of its surface is tangent to the bone while its long dimension is parallel to the bone axis e Do not use a circular motion The probe movement should follow parallel to the marked line e Probe movement should extend at least 1 centimeter but not more than 2 centimeters dorsal to the long marked line e Maintain the probe s surface in contact with the patient s skin throughout the scan No part of the probe surface should
211. the mouse then use the arrow button to move the selected sites to the right column All sites appearing in the right column will be added or updated when you click OK Use the same procedure for databases Each site has three components e Site parameters including the reference database if avail able e An instructional video illustrating the correct method for measuring SOS at the site and e The site skeletal image which appears on the Omnisense screen when the site is chosen This image is for illustrative purposes only and is not required for correct functioning of Omnisense To accept or decline a new instructional video for a site check or uncheck the Video checkbox on the dialog box When you select new sites to be added all three of the above components are automatically written to your Omnisense disk and will be available the next time you start the system If Omnisense detects that an earlier version of the site already exists it will ask you if you want to upgrade to the new version before proceeding After upgrading a site from a CD RW diskette click on Eject in the Administration menu to eject the diskette 16 26 Sunlight Omnisense 7000S 8000S ony wal aewa Research Mode For research clinics or other facilities engaged in compiling data on Omnisense SOS results Sunlight s Omnisense Research option supports the definition of new skeletal sites and the use of new or extended reference databases Data con
212. the average value for ages 20 to 40 as the young healthy population reference value However Sunlight found that SOS was not constant between ages 20 and 40 but instead gradually increases starting at age 20 and reaches a peak at around age 40 for most of the skeletal sites Thus the young healthy population mean is taken as the peak bone SOS which occurs for example at the radius at age 41 in the com pany s US Reference Database Study based on averaging the population SOS values within a window 5 years above and below each age point T and Z scores are defined as follows 2 20 Sunlight Omnisense 7000S 8000S Individualization of Treatment T score The difference between the patient s SOS result and the peak average SOS of young healthy population in units of population standard deviation Positive value means that the measured result is above the peak average SOS while negative value represents a value which is lower than the peak average SOS A value of T 2 means that the SOS of the patient is two population standard deviations below the peak average SOS Z score The difference between the patient s SOS result and the average SOS of a population of the same age and gender in units of population standard deviation A value of Z 0 5 means that the SOS of the patient is half a population standard deviation above the mean of her age matched peers T and Z scores provide additional information for bone assess men
213. the column headers For example if you click on the Family Name header the list will sort by family name e You can enter the patient s last name directly into the field at the bottom of the dialog box If the name exists the list will scroll directly to that name Once you have found the patient you want click on the patient s ID and the patient is selected Click OK to open the patient file 7 16 Sunlight Omnisense 7000S 8000S 7 3 7 4 Measurement Comments Measurement Comments Upon clicking the Measurement Comments button seen in Figure 7 6 Opening a patient file page 7 14 a dialog box opens enabling the physician to enter comments per examina tion per site per date Up to 256 characters of the text entered will appear in the measurement report This button is enabled when opening editing a patient file After performing the next measurement previous comments will not appear Deleting a Patient File This function enables deleting a patient from the patients data base together with his her entire clinical file To execute this function select a patient from the List of Patients and then select Delete Patient from the Patient Menu Patient gt Delete Patient Figure 7 8 Delete Patient menu Patient gt Delete Patient A Patient Measure Administration Research Help EV Ghd Ope GFO Edit Patient Ctrl E Delete Patient Close Ctrl C Show History Ctrl H Print GF
214. the metatarsal V 15 13 Patient position prior to marking the ROI 15 13 Marking the distal end of metatarsal V 00 15 14 L Gauge for use with metatarsal V 02 0 00000 15 14 Marking the scan region with the L gauge 15 15 Scanning the metatarsal V 0 0 eee eee 15 16 Accessing the practice mode 1 0 2 0 00 e eee eee eee 15 18 Practice mode warning 0 0 cece eens 15 18 Import dialog box 1 0 eee eee 16 2 Export dialog box 02 eee eee nena 16 5 Data conversion Menu 2 eee eee 16 9 Backup dialog Dox wc cc ci oe ba eek ee ded eae ees 16 10 Restore dialog box 0 0 teens 16 12 Print Setup dialog box 2 ketenes 16 14 Scan Disk dialog box 0 ccc ccc eee eens 16 16 Disk Defragmenter dialog box 0 002 cee eee eee 16 18 Format dialog BOX eneee ia a i E aA E ene 16 19 Export procedure saving the logger on a diskette 16 23 xix Figure 16 11 Figure 16 12 Figure 17 1 Figure 17 2 Figure 17 3 Figure 17 4 XX System upgrade initial dialog box anaana 16 24 Site update dialog box 6 ketenes 16 25 Omnisense Research Mode screen 0000 c eee ee ees 17 1 Edit site dialog box 0 teens 17 4 Advanced Options dialog box 2 0 0 0 cece cece eee 17 8 Reference Database Builder dialog box 000 17 10 Using this Guide 11 Outline
215. the type of movement and the direction and speed of that movement Names The names of screens and screen items will be indicated User Guide 1 5 CHAPTER 1 Using this Guide throughout the text according to the following formats Screens Menu headers and Dialog Boxes Screen menu headers and dialog window names are in normal text font capitalized Examples Measurement screen Options dialog Fields buttons menu items and checkboxes These names are shown in italic sans serif font upper case lower case or capitalized depending on how they appear on the screen Examples Current User Measurement Procedures Notes and Warnings Throughout this User Guide you will find Procedures a sequence of steps that are to be performed when using a certain feature or function of the Omnisense Sonometer Procedures begin with a Procedure heading and will be followed by num bered steps in the following format This is a Procedure Heading STEP 1 Name of first step in Procedure Explanation of first step in Procedure STEP 2 Name of second step in Procedure Explanation of second step in Procedure Note the icon at the left of the heading Your attention will be drawn to important points with the Note 1 6 Sunlight Omnisense 7000S 8000S Conventions Used in this Guide icon and style as below A Note to which your attention is drawn is indicated by the icon at left rules above and below the text
216. tic fracture for each patient based on his or her SOS measurement However inclusion of other risk factors in addition to the Patient Risk Assessment Index should be considered before User Guide 2 19 CHAPTER 2 2 8 Essential Prescribing Information making a final assessment of the patient in order to increase the sensitivity and specificity of physician s diagnosis Individualization of Treatment Omnisense measures the Speed of Sound SOS in m sec of an ultrasound wave that propagates along the bone These results may be used by the physician along with other factors such as laboratory test results radiographs life style and family history in the diagnosis of osteoporosis and other conditions leading to reduced bone strength and bone fragility The following detailed information is intended to guide the physician on how to interpret Omnisense results and its rela tionship to the currently accepted densitometry methods SOS Result T Score and Z Score Definitions Any patient measurement result consists of three different parameters The absolute result of the measured Speed of Sound SOS expressed in units of meters per second m sec For the pur poses of the following definitions the term young healthy pop ulation is defined as that age group in which bone mineral density BMD is at its peak Kanis et al 1997 For devices that show BMD to be constant between ages 20 to 40 it is typi cal to use
217. tient s Information form Use the procedure described below to open a patient file whenever required Upon creating a new patient file the patient file is opened For patients already registered there are two ways to open their patient file use whichever is convenient The starting point for either method is illustrated in Figure 7 6 Table 7 6 explains their use Figure 7 6 Opening a patient file Measurement Mode gt Single Site A Open patient direct method Site X 1 DISTAL RADIUS gt Probe CM Site Image Measurement Type E _ EPEE Patient Information Open patient Family Name DOO a button j H First Name Date of Bit 7 Measure 5 ment Height i Comments Weight button BMI Radius 7 14 Sunlight Omnisense 7000S 8000S Opening a Patient File Table 7 6 Opening a patient file Method Description Patient The left half of the screen displays patient Open information At the upper right of this sec Close but tion is the Patient Open Close button Click ton on this button and the Patient List dialog box displays Select the patient and click OK See Select Patient below When no patient file is open the Patient Open Close button is green indicating that one can open a file After a file has been opened the button becomes red indicating that the button is now Close only Direct Type the first letters of the patient s family entry name or th
218. tient Files 7 1 Patient Files To conduct an SOS measurement for a patient the patient s file must be open For every new patient you must create a file The patient file includes personal details referring physician etc Once created a patient file is opened simply by choosing it from the Patient List as described below To create a new patient file click Patient gt New Alternatively click on the left most button of the toolbar Omnisense displays the Patient Information Form illustrated in Figure 7 1 This form consists of four screens which we will refer to as tabs namely Common Osteoporosis Scheduler and Clinical Info The screens and tables below provide explanations on the items in the form User Guide 7 1 CHAPTER 7 Patient Files COMMON INFORMATION Figure 7 1 Patient Information dialog box Common screen Patient gt New or Toolbar gt New Patient gt Common A x Common Osteoporosis Scheduler Clinical Info Patient Identification Patient Address Patient ID m aaa Street Number Cancel Street Name Main Street Family Name m Smythe City Everytown First Name m Samantha Country State fusa Zip Code Date of Birth m 0102 1 950 gt Phone Reference A Database A American iaaa H Gender m Female C Male Physician x Operator sunlight T Allow only physician to view m required fields OK or Cancel h Table 7 1 Patient Informa
219. tion form fields Common Field Description Red Mark Fields with a red marker preceding them are ers mandatory the Omnisense software will not accept registration of a patient without them Others may be left blank if desired Patient ID Any convenient identification number for uniquely identifying patient information Social Security number is a typical use of this field You can use the ID number to search for and identify a patient Direct entry page 7 15 7 2 Sunlight Omnisense 70005 80005 Patient Files Field Description Family Family name and first name of patient and First Name Patient Partial information for address telephone Address number and reference database may etc appear automatically whenever the form is displayed for a new patient if these items have been set in the System Options screen 10 2 Setting System Default Options page 10 6 If these default items are not what you want select Administra tion gt Options gt Defaults and change them on the System Options screen This data can still be changed for the individual patient whatever the defaults are Gender Check box to indicate gender of patient This field is essential to determine the appropriate reference database used for the patient Refer Omnisense will determine how to interpret ence SOS values based on the choice of Refer Database ence Database selected at the lower right of the screen User Guid
220. tions are not available during measurement Similarly most measurement operations may not be performed while a management function is active On the next two pages you will find a graphical tour of all main features of the Omnisense system The diagram on page 5 2 describes Measurement operations and the diagram on page 5 3 gives details of Management operations The graphical description is followed by tables which provide more detail on the different operations available and how to access them User Guide 5 1 CHAPTER 5 Working with Omnisense Omnisense Measurement Mode Omnisense Measurement Mode Measurement Options Measurement Mode is where T Open patient file you will spend most of your Measurement Type E SingleSte H I time when working with Omnisense To enter Measurement Type B System Quality Verification measurement mode you Site J 1 staras must have a patient file open except when performing Choose a measurement type System Quality Verification Choose the skeletal site Patient Information PotientID 123345 a Measurement Ole T of 5 Elapsed Time 015 Family Name Smith f FirstName Jane Ei fal Date of Birth 6 21 42 Gender Female Height ee tint Weight 150 Lbs BMI Z Patient information is always open for the subject being scanned Viewing Measurement Koderomant REE Data You can view measurement results after three cycles of measu
221. tors are green The tone or absence thereof should be used as a guide without looking at the screen if the tone is heard the probe is being applied correctly Screen indicators are best used as an aid in learning correct measurement procedure The audible tone may be turned off by deselecting a checkbox found under Administration gt Options gt Settings Table 8 14 provides detail on the meaning and use of each of the elements on the screen CHAPTER 8 Patient SOS Measurement Table 8 14 Omnisense SOS measurement indicators Indicator Acoustic con tact indicator Function When an ultrasound signal is being con ducted along the bone and detected by the probe transducers the indicator is green Otherwise the indicator is red Acoustic sig nal acquisition indicator When a signal is being detected which is adequate for obtaining a meaningful result the traffic light is green If not it shows red Note that both the traffic light and the Acoustic Contact indicator must be green for SOS measurement to proceed correctly It is possible for the Acoustic Contact indicator to show green while the traffic light is red This means a sig nal is being detected but it is not ade quate for meaningful interpretation However the reverse is not possible Progress bar This indicator is found below the ana tomical picture of the site Omnisense requires the measurement cycle to pro ceed correctly for a c
222. trongly on the site being measured To draw any User Guide CHAPTER 8 Patient SOS Measurement statistically meaningful conclusions from an SOS result the conditions of the measurement should be as close as possible to those used in building the baseline data Therefore the exact procedure given in this Guide must be followed for each site Overall the method of measurement with Omnisense is similar regardless of the site being measured although there are some important points that vary from site to site In this chapter the correct method for measuring the Distal 1 3 Radius is presented in detail A careful reading of the two procedures which follow will ensure that you are familiar with the key points of correct measurement and will minimize inaccuracies in your results When measuring at other skeletal sites remember to check carefully for variations in the method See Chapter 14 Site Measurement Methodologies Positioning the limb and finding the site STEP 1 Position the patient and the limb SOS measurement at the Distal 1 3 Radius has been defined by Sunlight clinical research at a precise point on the limb which facilitates the easiest and most reproducible measurement This point is half way between the elbow and the end of the middle finger However to insure compatibility with the reference database it is important to locate the site precisely Always measure the patient s non dominant side In case
223. ttings to those appropriate for the chosen language The regional settings determined by the chosen language will appear in the lower four windows of the Language and Regional dialog box Decimal Symbol Date Format Time For mat and Calendar type The country name and country code in the Defaults tab of the Options window will also change auto matically If the formats are not appropriate for your clinic you may change them by changing the regional settings on the right side of this screen If you would like to use the English User Interface along with input in another language click on the Fonts button on this screen The Fonts button appears only with the English user interface The screen seen in Figure 10 13 Fonts dialog box page 10 19 will appear 10 18 Sunlight Omnisense 7000S 8000S User Interface Language Selection Figure 10 13 Fonts dialog box Regional and Language Options 2 x Advanced M Language for non Unicode programs This system setting enables non Unicode programs to display menus and dialogs in their native language It does not affect Unicode programs but it does apply to all users of this computer Select a language to match the language version of the non Unicode programs you want to use M Code page conversion tables 10000 MAC Roman 10001 MAC Japanese 10002 MAC Traditional Chinese Big5 10003 MAC Korean 10004 MAC Arabic 10005 MAC Hebrew
224. ty of the slots for a given combination of system and probe ranged from 0 18 to 1 01 0 25 overall Reproducibility of Operators and Probes In this type of study three operators and four CM probes were evaluated Similar studies were performed using four CR and four CS probes but for simplicity will not be reported here though the results are quite similar to those obtained with the CM probes Each operator measured the distal 1 3 radius of the subject three times with each probe As before all possible combinations probe and operator were tested for a total of 36 measurements 3 operators X 4 probes X 3 repeats The repro ducibility of the probes for a given combination of operator and repetition number ranged from 0 13 to 1 04 overall 0 52 Combining all repetitions for a single operator into one group the probe CV for different operators ranged from 0 60 to 0 83 The reproducibility for the operators for a given combination of probe and repetition number ranged from 0 19 to 0 80 overall 0 35 Combining all repetitions for a single operator into one group the probe CV for different operators ranged from 0 54 to 0 64 Reproducibility of Repeated Measurements In this type of study the SOS of each subject was measured at 2 12 Sunlight Omnisense 7000S 8000S Clinical Studies the given skeletal site using the appropriate probe type twice by three different operators Probes were repositioned between eac
225. ueue 15 5 Disk Utili ties page 15 16 and 15 6 Other Util ities page 15 22 Format Diskette Use this utility to format a diskette or disk see 15 5 Disk Utilities page 15 16 Eject CD RW Use this menu item to eject a CD RW disk from an 8000S device if it has not ejected automatically Service Export of a log file is provided by the Omnisense device as a service tool A description of this utility is provided in 15 7 Logger page 15 23 System Upgrade Used when you wish to install a newer version of the Omnisense software add a measurement site etc 15 8 System Upgrade page 15 24 Basic Operations Management Operations Function Description Site order This option allows changes in the default site order that appears in the Site drop down list It is most useful in the Research configuration Options This dialog box defines default set tings of the system some of which appear in the result printout and oth ers that affect everyday system opera tion Application Enables switching between the avail able applications optional Help These are found under the Help menu Help Topics The User Guide on line Measurement Methodologies Provides video demonstration of the correct measurement method for the current site Equivalent to clicking on the movie button on the toolbar Practice Mode Enable to practice measurements methodology without savi
226. uid detergents or soaps e DO NOT USE scrubbing materials or hard brushes that might scratch the probe head surface e Do not use cleaning agents that can damage or destroy plas tics such as ammonia acetone hydrochloric acid HCl chloride bleach etc Disinfection Immediately after cleaning the patient contact surfaces of the probe should be disinfected For disinfection it is not necessary to disconnect the probe from the Omnisense main unit The following steps should be followed for disinfecting the probes 1 The patient contact surfaces of the probe should be wiped dry to remove soil and filth before disinfection a towelette is used e Towelettes appropriate for use with Omnisense probes include the Sporicidin Disinfectant Towelettes which may be purchased from EDL Inc Danville VA USA Tel Number 1 800 342 5335 or Henkel Towelettes which may be purchased from Henkel Ecolab Dusseldorf Ger many Tel Number 49 211 98930 2 Thoroughly wet surface with towelette Ensure surface remains for a 10 minute contact time at room temperature 20 C 68 F or above 3 Discard used towelettes and empty container in regular trash Precautionary Notes e Do not immerse the probe in liquid disinfectants User Guide 12 3 CHAPTER 12 Cleaning and Disinfecting Omnisense e To avoid possible damage to the probe do not employ ster ilization methods that would expose the probe to heating steam pres
227. unlight Desk top page 11 1 Switching between Applications If you have more than one application installed on your Omnisense device you may want to switch between applica tions during your working day You need not shut down the device and start it again to do so instead Omnisense provides User Guide 4 29 CHAPTER 4 Initial Setup two methods for switching between applications Click Administration gt Application and the desired application or Exit to the Sunlight Desktop through Patient gt Exit and choose the icon of another application to enter that application 4 30 Sunlight Omnisense 7000S 8000S oN awe Working with Omnisense 5 1 This chapter provides a high level guide to navigating Omnisense system functions Basic Operations Omnisense functions support two basic types of operations Measurement Operations and Management Operations Your time spent with Omnisense divides between these types as fol lows Measurement Operations All aspects of SOS measurement are handled here the SOS measurement itself and viewing printing measurement results System Quality Verification is also considered part of measurement operations Management Operations These cover all functions not directly related to SOS measurement Included are user security and management patient security and management utilities for installing and configuring printers and data storage and backup operations Management opera
228. up Format Diskette and License Status are available at all times All other facilities described in this chapter are not available while a patient file is open Import and Export of Patient Data At times you may wish to send a patient file to another clinic or to a hospital or receive a patient file from outside sources Omnisense supports such transfer with the Import Export facil ity Import and Export of patient data is supported only between Omnisense systems Furthermore the Omnisense importing the data must have equivalent skeletal site capability and reference database as the Omnisense that exported that data User Guide 16 1 CHAPTER 16 Utilities and Peripherals Q Import Patient Data STEP 1 Open the Import dialog box Select Import from the Patient menu You will see the dialog window illustrated below Figure 16 1 Import dialog box Patient gt Import A Import Patient x DB Serial Patients ID Family name First name Updated __Selectall_ I Auto Insertion mode _Unselectall Drive for an Drive A Floppy 1 44 Mb z Drive A Floppy 1 44 Mb Drive F lomega 100 Mb OK or Cancel v STEP 2 Insert patient data volume In the drive window at the bottom of the dialog box select the drive desired Insert the disk containing your patient information into the selected drive STEP 3 Specify Import parameters The Import facility is selective i e you choose which patient data are
229. ure that you have the correct backup before carrying out the Restore procedure gt Please note that the Restore procedure replaces the STEP 3 Execute the Restore Click OK and the Restore operation will proceed It may take a few minutes to complete If you have restored data from a CD RW diskette the diskette will automatically eject from the drive when the procedure is complete 16 4 Print Setup Sunlight s recommended printer list appears on the Sunlight website at http www sunlightmedical com International html User Guide 16 13 CHAPTER 16 Utilities and Peripherals printers html The print setup dialog box allows you to configure a number of parameters which will apply when printing such as paper size and orientation Normally you set these once and they apply automatically for all printing You need to reset them only in case of significant changes such as a new printer or change in your standard paper size First open Print Setup from the Administration menu The Print Setup dialog box is displayed Figure 16 6 Print Setup dialog box Administration gt Print Setup A HP DeskJet 690C Automatically Select OK or Cancel Vv 16 14 Sunlight Omnisense 7000S 8000S 16 5 Disk Utilities Table 16 4 explains each of the fields Table 16 4 Printer Setup fields Field Purpose Printer Select the printer to be used from the drop Name down list Paper Size Specify the size of
230. ure 4 12 Figure 4 13 Figure 4 14 Figure 4 15 Figure 4 16 Figure 4 17 Figure 4 18 Figure 4 19 Figure 4 20 Figure 5 1 Figure 6 1 Figure 6 2 Figure 6 3 Figure 6 4 Figure 6 5 Figure 6 6 Figure 6 7 Figure 6 8 Figure 7 1 Figure 7 2 Figure 7 3 Figure 7 4 List of Figures Example Screens a eter alae Gating kl naires ea E eng ena a a 1 7 Moving Average SOS by Age Distal 1 3 Radius 2 7 Ultrasound wave transmission with the Omnisense probe 3 3 Omnisense 7000S main unit front view 2 0 4 4 5 Omnisense 7000S main unit rear view 02 0 000 4 6 Omnisense 8000S main unit front view 2 64 4 8 Omnisense 8000S main unit side view 204 4 8 Omnisense 8000S main unit rear view 2 0 000 4 9 Phantom for system quality verification 04 4 10 Limb positioning fixtures 00 00 eee eee eee 4 1 Measuring gauges 0 eet eens 4 11 Pins on a probe connector nnana cette eee 4 14 Probe slots on Omnisense 8000 0 00 e eee eee eee 4 18 Sunlight Desktop opening screen 00 cece eee eee 4 19 Initial login dialog box 02 0 0 eee cee eee 4 20 User Listiscreetics es icti ey eae ak hd te eres Mie ee 4 22 Change password dialog box 0 eee e eee ees 4 22 Adding users with the User List screen 004 4 24 System Options dialog box Settings screen 4 25 Ti
231. ure described next User Guide 16 11 CHAPTER 16 Utilities and Peripherals Q Restore Procedure STEP 1 Open the Restore dialog box Select Restore from the Administration menu The Restore dialog box is displayed Figure 16 5 Restore dialog box Administration gt Backup A Restore from Backup x DE serial number Backup Date yf T x FILS Date of Database No previous Backups found Date of Patient list Restore from drive Drive A Floppy 1 44 Mb z Drive A Floppy 1 44 Mb T Drive F lomega 100 Mb OK or Cancel Vv STEP 2 Check that you have the correct Backup There are no parameters to set in the Restore dialog box The entire system is simply replaced with the one from the Backup disk The fields in the dialog 16 12 Sunlight Omnisense 7000S 8000S Print Setup box are informational they give important dates by which you can determine if you should execute the Restore as described in the table below Table 16 3 Restore dialog box information Screen Item Function Date of Indicates the most recent date of changes Database to system options for the system on the Backup disk Date of Indicates the most recent date of changes Patient to the patient file for the system on the Backup disk Changes to patient results are not reflected only additions deletions or modifications to Patient Forms affect this date entire current database on your system Please ens
232. ustors 5 Network socket 6 USB ports not used 7 Keyboard Mouse socket 8 Printer output User Guide 4 9 CHAPTER 4 Initial Setup 9 Foot pedal socket COM1 10 COM 2 3 4 not used 4 4 Measurement Accessories The photograph below shows a phantom The phantom is con structed of Perspex material which has known stable SOS behavior It is used to verify that Omnisense is measuring speed of sound accurately The procedure is described in Chapter 6 System Quality Verification page 6 1 Figure 4 6 Phantom for system quality verification The phantom has an LCD temperature gauge on one side and a con version table on the a 7 Oot fe a Td hd other A hand rest is provided with Omnisense for use in positioning a patient s arm correctly for a SOS measurement of the distal 1 3 radius The hand rest is illustrated in the photograph below 4 10 Sunlight Omnisense 7000S 8000S The hand rest supports the lateral edge of the outstretched palm when scanning the Radius At left is the gauge used to locate the scan site for the Radius The gauge at right is used to locate the scan site at the Prox imal Phalanx and the Metatarsal Measurement Accessories Figure 4 7 Limb positioning fixtures SOS measurements of the distal radius are taken at about the midpoint of the limb while measurements of the phalanx and metatarsal are located along the respective bones To aid in finding the co
233. utton 6 A new window opens listing the two sites selected for mea surement and you are prompted to select a first site to be measured see Figure 9 9 Click OK to close the screen User Guide 9 11 CHAPTER 9 Interpreting the Results of a Measurement Figure 9 9 Multi site measurement site listing Choose Multi Site RADIUS Site was not measured today PROXIMAL PHALANX III Site was not measured today 7 Start measuring the selected site The measuring operation is carried out in the same manner as in a single site measure ment Once the measurement is completed click on the Results button A graph and a table showing the measure ment results will be displayed on the screen see Figure 9 10 Figure 9 10 First site measurement result Previous value Current value 20 25 30 35 40 45 50 55 60 65 70 75 80 85 Agelyears 8 By clicking on the lower rightmost button on the screen you will save the measurement result obtained and move to the next site 9 12 Sunlight Omnisense 7000S 8000S Multi Site Measurements 9 The Site Listing screen reappears indicating that one site has been measured and prompts you to select the second site to be measured see Figure 9 7 Select the second site and press OK to close the window Figure 9 11 Select a second site for measurement Choose Multi Site Multi Site list Site name Today s measurements DISTAL RADIUS Site was measured today PROXIMAL P
234. with important controls ports and connectors as well the accessories used in patient measurement Identifying System Components for Omnisense 7000S The next figures illustrate the Omnisense main unit front and rear panels Verify that the unit you received has connectors and features as described below 4 4 Sunlight Omnisense 7000S 8000S Identifying System Components Figure 4 1 Omnisense 7000S main unit front view Table 4 1 Omnisense 7000S Front Panel Indicators and Ports 1 Probes 2 Probes holder 3 ZIP drive slot in some models CD RW slot 4 3 5 diskette slot 5 Hard disk drive LED indicator 6 Omnisense operation LED indicator 7 Main power switch User Guide 4 5 CHAPTER 4 Initial Setup The probes used for scanning skeletal sites and all other cables and connectors connect to sockets and ports on the rear panel see 4 2 Omnisense 7000S main unit rear view below The rear panel of the Omnisense unit is illustrated in the next figure Familiarize yourself with the sockets at the back of the unit and check that they correspond to those specified below Figure 4 2 Omnisense 7000S main unit rear view Table 4 2 Omnisense 7000S Rear Panel sockets and ports 1 Probe slots 2 Type B IEC 601 1 symbol 3 USB socket 4 Network socket 5 Keyboard socket 6 Mouse socket 7 Earphone socket optional 8 Power outlet for LCD monitor 4 6
235. y patient ID exported found identical to an existing one and by the display a warning asking you if the same import data should replace the existing device record With Autoinsert checked Import overwrites patient records with identical IDs no warnings are dis played Import is With Autoinsert unchecked using data Import will stop at every patient ID exported found identical to an existing one and by a differ display a warning You will be asked to ent device provide a different ID for the imported patient With Autoinsert checked Import appends the number 1 to the IDs of patients found with ID identical to one in the system thus distinguishing them No warnings are displayed The data for an Import are created using the Export operation described next Export Patient Data STEP 1 Open the Export dialog box Select Export from the Patient menu The following dialog box is displayed Import and Export of Patient Data Figure 16 2 Export dialog box Export Patient x Patient gt Export A Patients 38756348 56799239 57487134 64528298 Test STEP 2 STEP 3 Select All m Use Security Unselect All Drive for Import files Free space Drive A Floppy 1 44 Mb Drive A Floppy 1 44 Mb Drive F lomega 100 Mb Jackson Johnson Amy Lasko Shlomo Smith Jane Test Test OK or Cancel h Insert media volume In the drive window at the bottom of the dialog box

Omnisense 8000S User Manual - Pear Healthcare Solutions Inc.

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