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Norland Elite 437A150, Operator'S Manual

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Norland Elite 437A150 Operator'S Manual Download Page 441

Operator's Guide
437D140 Rev. I

Technical Reference

17-13

Cautions

General Cautions

Caution:

Do not touch the patient and the computer system, or other non-ME equipment parts, at the

same time as this could increase leakage currents.

Caution:

Device is not designed to be defibrillator proof.

Caution:

Device is not intended for use in conjunction with flammable agents.

Caution:

Device is not anesthesia proof.

Caution:

Device is not intended for use in oxygen rich environments.

Caution:

Not a patient connected device; patient equalization terminal not provided.

Caution:

The laser within this product is not user serviceable. In the event it fails to operate, contact

Norland Technical Support.

Caution:

Use of controls or adjustments or performance of procedures other than those specified may

result in hazardous radiation exposure.

Caution:

Follow the procedures in the General Maintenance section of this manual to insure patient

data is not lost.

Note:

The device of which this x-ray source is a part is a Class I device, (per clause 5 of EN60601-1).

However, this x-ray source is not designed, intended, or capable of operating as a stand-alone x-ray
source.

Note:

There are no user serviceable parts or user accessible fuses inside the unit.

Summary of Contents for Elite 437A150

Page 1: ...DXA Bone Densitometer Operator s Guide Elite Model 437A150 Operator s Guide 437D140 Rev I...

Page 2: ...e trademarks of Norland All trademarks and the rights of the trademarks owned by the companies referred to in this Operator s Guide and other written materials provided to Licensee with the Bone Asses...

Page 3: ...rmit or provide access to the Software to any other person Licensee will not engage in the oper ation of any illegal business or use or permit anyone else to use the Software or any part thereof for a...

Page 4: ...reclude any other or further exercise thereof or the exercise of any other right power or privilege under this Agreement If any of the pro visions of this Agreement or application thereof to any perso...

Page 5: ...3 Technique Factors 2 3 Communication Watchdog 2 3 Exposure Indicators 2 3 Radiation Shielding 2 3 Audible Indicator 2 3 Scanner Features 2 3 Dual Energy X Ray Absorptiometry DXA 2 4 Dynamic Filterin...

Page 6: ...ogging into the Illuminatus DXA Software 3 11 Examining the Software 3 12 Database Navigator Window 3 13 Database Navigator Window Description 3 14 Menu Commands Overview 3 15 File Command 3 16 Quick...

Page 7: ...top the Calibration 4 17 QA Results tab Window Interpretation 4 18 QC Results Statistics Messages 4 19 Preparing Patient Records 4 21 Creating a New Record for a New Patient 4 21 Locating a Record for...

Page 8: ...g AP Spine Scan Specifications 7 2 Patient Dose 7 3 Operator Dose 7 3 Maintaining High Quality AP Spine Scans 7 4 General Patient Scanning Cautions 7 5 Quick Reference AP Spine Scan 7 6 Scan Procedure...

Page 9: ...hecklist 9 7 Preparing the Patient for Scanning 9 7 Update or Create the Patient s Record 9 7 Setting the Scan Parameters 9 8 Positioning the Patient Subject 9 10 Marking the Scan Region 9 11 Starting...

Page 10: ...13 Database Management 11 14 Creating a Database Folder 11 15 Active Database Remove From List 11 16 Active Database Add to List 11 17 Importing a Database 11 18 Exporting a Database 11 20 Deleting Pa...

Page 11: ...Scanning Techniques 11 75 Changing the Scan Parameters Prior to Scanning 11 75 Lateral Spine Scanning Techniques 11 76 Changing the Scan Parameters Prior to Scanning 11 76 Unsatisfactory Scout Scan L...

Page 12: ...n and Region Parameters 14 4 Patient Filtering 14 5 Loading and Saving Setups 14 7 Exporting Data 14 8 Patient Personal and Scan Export Parameters 14 9 General Maintenance Routine Maintenance 15 2 Cle...

Page 13: ...ironment 17 4 Focal Spot to Image Receptor Distance SID 17 4 X ray Generator 17 4 Classification 17 4 Cooling Curves Tube Rating Charts 17 5 Duty Cycle 17 5 Technique or Loading Factors 17 5 Electrica...

Page 14: ...8 6 Norland Fracture Risk 18 6 Excerpt from Calcified Tissue International 18 7 Excerpt from the Journal of Bone and Mineral Research 18 8 Norland Reference Data Set Values 18 10 NHANES III Reference...

Page 15: ...fied Norland s Quality Management System is certified to ISO 13485 2003 Norland is dedicated to providing a quality product on time delivery and exceptional customer service Caution State law requires...

Page 16: ...e harmful to developing fetuses A bone density study should not be performed within 10 half lives of a radionuclide uptake procedure The sys tem detectors may misinterpret residual emissions from rece...

Page 17: ...on The figure on on page 17 19 Scanner Labels shows the Identification Label which has the instrument serial number on it Domestic North America Latin America Norland W6340 Hackbarth Road Fort Atkinso...

Page 18: ...explain how to prepare a new patient database record as well as how to edit an existing patient s record Next the Patient Demographics window is dis cussed in detail And finally the chapter wraps up w...

Page 19: ...rating Ten Year Fracture Risk Assess ment reports Chapter 13 DICOM Interface contains information on using this feature DICOM Digital Imaging and Com munications in Medicine is a global IT standard th...

Page 20: ...lpful notes or additional procedure steps Indicates radiation from laser positioning aid ON OFF Power Switch Turn the scanner ON and OFF by depressing the power switch located on the lower inside righ...

Page 21: ...g the LASER button on the Scanner Arm Touch Pad When the laser is ON the indicator next to the button is illuminated yellow The MARK button is used to identify and mark the scan area The READY indicat...

Page 22: ...This page intentionally left blank Operator s Guide 437D140 Rev I 1 8...

Page 23: ...is as well as an aid in assessing risk of fracture Information on radiation safety and some of the operational characteristics of the Nor land system are on the following pages Sample printouts of the...

Page 24: ...o be less than 0 1 mRem per hour three feet from the beam and is only present when x rays are being emit ted such as during the scan Although this amount of scatter radiation is relatively low minimiz...

Page 25: ...s data collection communication during the scan If communication fails the exposure is terminated Exposure Indicators The green READY indicator on the Scanner Arm Touch Pad illuminates to indicate tha...

Page 26: ...lement is placed in the beam path and x rays are sharply attenuated at energy levels par ticular to that element Norland uses samarium as the filter material because it produces energy peaks at 46 8ke...

Page 27: ...in the scanner arm The x ray source is specially designed for densitometry and has a low operating temperature and long life Figure 2 1 Elite Scanner Scanner Arm Touch Pad The Scanner Arm contains th...

Page 28: ...s manufacturing facility as required by the FDA Software The Norland Bone Densitometer software conforms to a Windows style design for ease of use and familiarity Features of the Norland software incl...

Page 29: ...s in a position best suited for accurate and precise hip scans Leg Separator Block 388D550 Used with hip sling to achieve proper abduction Leg Rest Block 433D132 Used to raise the legs to straighten t...

Page 30: ...ected and the results of the QA Calibration Standard and the QC Phantom scans are displayed QA results should be printed and kept in a paper log file for quick reference Norland software will automati...

Page 31: ...ange C V of 0 9 a C V of 1 4 b If the first value is 1 0 g cm2 then change must be 0 025g cm2 If the first value is 1 0 g cm2 then change must be 0 039 g cm2 Note C V s for individual facilities may b...

Page 32: ...nt of Variation C V Coefficient of Variation is used to specify precision It is the standard deviation expressed as a percent of the measured quantity The coefficient of variation is the standard devi...

Page 33: ...ion has no identifiable risk of fracture Medium Risk Yellow Represents the range of values determined by WHO to be osteopenic having low bone mineral The BMD T Score values in this region range are mo...

Page 34: ...e a report using the cur rently selected report template Follow these steps to generate a Report from Stamp View or Filmstrip View 1 Make sure that the scanned image is being viewed as a thumbnail in...

Page 35: ...ick to lock a report which prevents it from being deleted It can still be edited Click to save a report without printing It will appear on the Reports tab Click to automatically save and print a repor...

Page 36: ...t at once All of the Reports generated will appear in this list along with the date they were created Double clicking on any of the Report names will open the Report for viewing To view and print any...

Page 37: ...Operator s Guide 437D140 Rev I General Information 2 15 To modify a locked Report click on Tools Report Make Addendum Make any edits to the Comments field as necessary Click then...

Page 38: ...added to either report using a checklist To edit the Scan Quality Issues checklist click on Tools Report Scan Quality Issues Editor To edit the Recommendations checklist click on Tools Report Recomme...

Page 39: ...gion of interest Quantities of bone mass are reported as Bone Mineral Dens ity BMD Bone Mineral Content BMC and Area The BMD is BMC divided by Area and is expressed in grams per square centimeter The...

Page 40: ...1 A Sample Bone Exam Report A sample 2 page Bone Exam Report is included here for reference Figure 2 5 Page 1 of the Bone Exam Report Operator s Guide 437D140 Rev I 2 18 General Information...

Page 41: ...Operator s Guide 437D140 Rev I General Information 2 19 Figure 2 6 Page 2 of the Bone Exam Report...

Page 42: ...2 page Bone Exam Report is condensed down to form this one page report with basic patient information and reference graphs for all regions of interest as shown next Figure 2 7 The Bone Exam Report 1 P...

Page 43: ...I General Information 2 21 3 A Sample Combined Report The physician has the option to combine the results of two different bone scans of a single visit into a one page Combined Report as shown next Fi...

Page 44: ...he primary physician Patient Letters can be generated for a single scan or a combination of two different scans from the same visit Scan Quality Issues and Recommendations can be selected from a check...

Page 45: ...Operator s Guide 437D140 Rev I General Information 2 23 Figure 2 10 Page 2 of the Patient Letter...

Page 46: ...facility that did the scan Referral Letters can be generated for a single scan or a combination of two different scans from the same visit Scan Quality Issues and Recommendations can be selected from...

Page 47: ...Operator s Guide 437D140 Rev I General Information 2 25 Figure 2 12 Page 2 of the Referral Letter...

Page 48: ...the patient s probability of a future fracture This report can only be generated for hip scans and is only available when the Ten Year Fracture Risk option is enabled Figure 2 13 Page 1 of the Ten Ye...

Page 49: ...Operator s Guide 437D140 Rev I General Information 2 27 Figure 2 14 Page 2 of the Ten Year Fracture Risk Report...

Page 50: ...Body scan to produce Body Fat Percentage results This report can only be generated for Whole Body scans and is only available when the Body Composition Reports option is enabled Figure 2 15 Page 1 of...

Page 51: ...Operator s Guide 437D140 Rev I General Information 2 29 Figure 2 16 Page 2 of the Body Composition Report with trended results...

Page 52: ...ts model or options Upon completion of this process the operator is asked to print the results These reports labeled QC Res ults should be filed in a calibration log file as described in section View...

Page 53: ...Operator s Guide 437D140 Rev I General Information 2 31 Sample Reports Quality Assurance Report BMD Figure 2 17 QC Results BMD...

Page 54: ...Sample Reports Quality Assurance Report Fat Figure 2 18 QC Results Fat an option Operator s Guide 437D140 Rev I 2 32 General Information...

Page 55: ...Operator s Guide 437D140 Rev I General Information 2 33 Sample Reports Quality Assurance Report Lean Figure 2 19 QC Results Lean an option...

Page 56: ...This page intentionally left blank Operator s Guide 437D140 Rev I 2 34...

Page 57: ...main menu commands File Edit Calibration Tools and Help are discussed in detail Numerous software screen shots are reproduced here for reference Instructions for setting the scanner parameter default...

Page 58: ...closed 2 Insert the software installation CD into the drive or run the stand alone software installation program 3 Select the installation language then click OK 4 The Welcome window appears Click to...

Page 59: ...Setup 3 3 6 Norland recommends that you keep the default Destination Folder If you do not certain files will not be cre ated correctly and the software will not be able to find them Click 7 The applic...

Page 60: ...installation Click OK when completed 9 If the Acrobat Reader option was selected follow the installation prompts to install Acrobat Reader 10 After all features have been installed click to complete t...

Page 61: ...dows 10 Computers provided by Norland with Windows 10 include the EaseUS Todo Backup program to automatically perform a backup of the IlluminatusDXA software and data on a daily schedule To configure...

Page 62: ...be used for backup into an available USB port 2 To allow the backup program to utilize the full capacity of the USB drive drives should be formatted with an NTFS filesystem 3 Click the Start menu All...

Page 63: ...s 4 Click the Audio tab Then click the Sound Recording button 5 Click the Microphone Select check box then adjust the slide bar to the middle setting 6 Click the to close the dialog box 7 Click to app...

Page 64: ...he computer to confirm all programs have been closed 2 Remove the HASP USB key 3 Click Start Control Panel 4 Double click on Add or Remove Programs 5 Scroll down to select Illuminatus DXA and click Th...

Page 65: ...completely remove your patient Databases click or leave them installed click Caution Selecting Yes will permanently delete all of your patient data and scanner setup files 9 Wait while the software c...

Page 66: ...11 Click Operator s Guide 437D140 Rev I 3 10 Installation and Setup...

Page 67: ...key is plugged into the USB port 2 Double click the icon on the desktop labeled Illuminatus DXA to start the software OR click on Start Programs Norland Illuminatus DXA 3 First time login The followi...

Page 68: ...r window All Norland program actions are initiated by moving a mouse pointer to the menu bar located along the top of the window or the navigation but tons along the bottom of the window Hot keys are...

Page 69: ...e current user account in the host software and goes to the login window Displays a blank Patient Demographics window It is used for inputting information on a new patient Displays the current patient...

Page 70: ...ch by Patient Name viewed in the Category drop down list The operator simply selects the search Category ID or Name and types the first few characters The search is interactive and will return all val...

Page 71: ...menu names along the top of the Database Navigator win dow a list of commands drop down Some commands are grayed out due to one of the following reasons The option is not valid for the current operati...

Page 72: ...1 Addi tional Techniques under Database Management on page 11 14 Reference Sets displays the Reference Set window Right click on any entry in that window to Edit or Delete a reference Reference Set de...

Page 73: ...re Factory Defaults button restore the original factory settings See Scan ning Tab Setup on page 3 22 The Analysis tab includes an area for each scan type Each scan type has its own parameters that ca...

Page 74: ...assword e mail address and the width and height of the Stamp View thumbnail Users User s Groups contains the Group List Users Additional Settings has Security Privileges settings Groups tab contains t...

Page 75: ...ndows that lets the current user change their login and e mail information The width and height of the Stamp View thumbnail that is displayed in the Stamp View window can be set here also Click on Edi...

Page 76: ...cations training Settings will be dis cussed with the operator during the training to ensure a complete understanding The scanner preferences can be customized to suit each facility s needs However wh...

Page 77: ...scanner identification information The available software options are displayed once the Options Authorization Code OAC is entered by the installer Enter the Scanner Serial Number To use a serial port...

Page 78: ...setup options are typically reviewed and modified during system installation or during training The different parameters are described in the next few sections Figure 3 4 The Scanning tab preferences...

Page 79: ...ution the data point size x scan line size in millimeters The scan resolution is 1 0 x 1 0mm or 1 5 x 1 5mm default Scan Width displays the width of the scan in centimeters The Scan Width is 12 cm def...

Page 80: ...any of the scan parameters such as resolution scan width or speed Click and at the bottom of the window These settings now become the default settings until changed again PARAMETER DESCRIPTIONS Resol...

Page 81: ...parameters in the window shown above Select and change any of the scan parameters such as resolution scan width or speed Click and at the bottom of the window These settings now become the default set...

Page 82: ...e Navigator window as described next If it is not already open click on Edit Scanner Preferences Scanning tab Locate the Whole Body scan parameters in the window shown above Select and change any of t...

Page 83: ...window shown above Select and change any of the scan parameters such as resolution scan width or speed Click and at the bottom of the window These settings now become the default settings until change...

Page 84: ...T TO DO To change the default Scan parameters access the Scanner Preferences win dow from the main Database Navigator window as described next If it is not already open click on Edit Scanner Preferenc...

Page 85: ...Force initial scan on axis forces end point of initial scan to be on same Y axis as the start point Maximum degrees to snap final scan on axis This field defines the maximum degree of rotation of the...

Page 86: ...lt parameters for all the analysis operations are set and reset here These setup options are typically reviewed and modified during system installation or during training The different parameters are...

Page 87: ...nged again PARAMETER DESCRIPTIONS Analysis Mode refers to the cursors The Standard option displays the cursors in the horizontal plane The Angulated option allows the cursors to be positioned at whate...

Page 88: ...ble to attain a 1 5 cm region High Density Point Exclusion when checked enabled it will exclude data points with a density 3 75 g cm2 from the analysis In addition the note HD Point Exclusion will be...

Page 89: ...er Preferences Analysis tab Locate the Forearm analysis parameters in the window shown above Select and change any of the analysis parameters see Parameter Descriptions below Click and at the bottom o...

Page 90: ...te HD Point Exclusion will be printed under the scan image of the Bone Exam Report TO EXCLUDE HIGH DENSITY OBJECTS FROM THE ANALYSIS The system software is equipped with a feature that will exclude hi...

Page 91: ...canner Preferences Analysis tab Locate the Lateral Spine analysis parameters in the window shown above Select and change any of the analysis parameters see Parameter Descriptions below Click and at th...

Page 92: ...SCRIPTIONS High Density Point Exclusion when checked enabled it will exclude data points with a density 3 75 g cm2 from the analysis In addition the note HD Point Exclusion will be printed under the s...

Page 93: ...mass measurements Regional R Value Analyzed scans using individual R Values for each Region of Interest instead of a global R Value Note The same R Value setting should be used for all scans of the s...

Page 94: ...so be exported to a DICOM file but only if the DICOM interface has been enabled The default destination is to a PDF file when disabled Disable System calibration Instructions when checked enabled the...

Page 95: ...Color is enabled the reference graphs on all screens and reports will always be displayed in color If the setting is disabled and the Image Color is set to Grayscale reference graphs will also be disp...

Page 96: ...lick on Edit Advanced Preferences and click on the Reporting tab Enabling the Print Siri Graph option will show the Siri UWE Fat Table on Whole Body reports when Soft Tis sue Composition is enabled Wh...

Page 97: ...ail option to work Directory Settings for the MAPI Server Type Follow this procedure to set the proper directory path when using a MAPI server type Click on Edit Advanced Preferences and click on the...

Page 98: ...ories tab Click Network Tab The Network tab allows your IT administrator to enter the SMTP Server host name Click on Edit Advanced Preferences and click on the Network tab to open the following window...

Page 99: ...server be entered in the white box labeled SMTP Server as shown above The setting mail ouroffice com was used in this example Selecting the Server Type MAPI from the drop down list will use your curr...

Page 100: ...gin name and password e mail address and the width and height of the Stamp View thumbnail User s Groups contains the Group List Additional Settings has Security Privileges settings Note WHAT TO DO Sel...

Page 101: ...437D140 Rev I Installation and Setup 3 45 Note WHAT TO DO Select the tab related to the function you want to perform Type in the inform ation being changed Click the appropriate button New Edit Cancel...

Page 102: ...ed daily See Daily Calibration Procedure on page 4 6 for the complete QA procedures QC Scan prepares the system for a scan of the QC Phantom independent of the QA procedure Results displays most recen...

Page 103: ...Type Values This command will update the scan types on all previously generated reports in all databases The command will disappear from the menu once it has been executed once DICOM Interface This co...

Page 104: ...scanner arm to the origin at the left rear corner of the machine A dialog box opens warning the user that the table origin will be found and the patient should be kept out of the way The operator has...

Page 105: ...oubleshooting efforts It moves the scanner arm to the origin position and to the opposite corner to define the scan area A dia log box opens warning the operator that the table dimensions will be foun...

Page 106: ...ould only be used under the direction of Technical Support The cal ibration process will run for a minimum of 6 hours and once the process is started it is not possible to scan patients until it has c...

Page 107: ...n the Database Navigator window Quick Descriptions Help drop down list Help Topics opens the Illuminatus Operator s Guide About opens a window describing information about the Illuminatus software and...

Page 108: ...This page intentionally left blank Operator s Guide 437D140 Rev I 3 52...

Page 109: ...ing patient s record are discussed in detail From there you are instructed to go to the pertinent scan type chapter AP Spine Hip Scan etc to continue the scan A discussion of the buttons and fields av...

Page 110: ...the scan immediately or save the scan data and ana lyze it later 6 After scan analysis is completed the results are saved to a default storage location and printed or sent to DICOM Guidelines for Atta...

Page 111: ...prior to patient scanning as part of a regular Quality Assurance Program The operator should follow these instructions to power up the Norland Bone Densitometer system after it has been shut down IMPO...

Page 112: ...k the button to start the software 3 If the scanner was previously turned off and back on you will be prompted to initialize the scanner Wait while the Scanner initializes Caution The Scanner Arm will...

Page 113: ...n or perform an analysis on an existing scan To ensure a high level of precision and accuracy a System Calibration should be performed at the beginning of the day when patient scans will occur The dai...

Page 114: ...nal elements in the QA Calibration Standard become misaligned bent or cracked This kind of damage can occur if the Standard is dropped a Check the QA Calibration Standard for bent corners or damaged p...

Page 115: ...or responding marks on the scanner table surface Point A on the calibration standard will face the head to the right of the table Figure 4 6 Positioning the QA Calibration Standard and QC Phantom b Pl...

Page 116: ...he top labeled Calibration Figure 4 7 The Calibration window with Calibration tab selected b Notice that Daily in the Calibration window is selected Confirm that the Scan QC Phantom box is checked Cau...

Page 117: ...er positioning dot is on the on the Calibration Standard Plexiglas surface marked A in the figure below f Press The laser will blink off then back on The computer will emit an audible sound signifying...

Page 118: ...on the QC Phantom see figure below c Press to mark point C d The scanner will automatically move to the approximate location of point D Move the laser to point D e Press to mark point D f As soon as...

Page 119: ...cur See the fig ure below Figure 4 8 Daily Calibration in progress b Notice that the current scanner tasks are displayed in the lower left hand portion of the window They mark the phases of the calibr...

Page 120: ...HE QA RESULTS TAB The QA Results screen will be displayed at the completion of the QC Scan The entire process takes approximately 30 minutes to complete Figure 4 10 QA Results Screen Operator s Guide...

Page 121: ...bration Option Only Verify that the PRECISION and ACCURACY fields for the Fat are labeled OK see figure below Click on to view the Fat Precision and Accuracy graphs LEAN For Soft Tissue Calibration Op...

Page 122: ...t s can be created by exporting the report s Reports may be exported to either PDF or DICOM format by clicking the button The export type is determined by the setting in Scan ner Preferences For PDF f...

Page 123: ...close the dialog box 4 FOR A FAT REPORT Click to display the Fat QC results Click Click Click 5 FOR A LEAN REPORT Click to display the Lean QC results Click Click Click 6 Click to close the QA Result...

Page 124: ...Sample Printed QA Results Report Operator s Guide 437D140 Rev I 4 16 Basic Operation...

Page 125: ...fail a second time turn OFF the power to the scanner Turn it back on leave the com puter on Retry the calibration Caution The Scanner Arm will move when the scanner is turned on STAY CLEAR OF THE SCA...

Page 126: ...igure 4 12 Sample QA Results tab window An examination of the window above reveals the information grouped into four areas Calibration Details Cal ibration Standard QC Phantom and QC Results The right...

Page 127: ...he dashed lines are those scans that exceed the 2 S D LOWER GRAPH displays the accuracy of the system based on QC Phantom scans The mean values of the last 180 days of calculations 6 months are plotte...

Page 128: ...ing the QA Calibration Standard on page 4 8 Table 4 9 QA Results tab Accuracy Messages and Actions Note The Daily System Quality Assurance Calibration should be repeated if An OUT OF RANGE message is...

Page 129: ...DICOM Worklist Creating a New Record for a New Patient This section discusses the procedures to create a record for a new patient See Patient Demographics Win dow Details on page 4 25 for a thorough...

Page 130: ...avigator window A scroll down the Patient Name column B use the Quick Search field to search by Patient Name C or use the Quick Search field to search by Patient ID A Search in the Patient Name Column...

Page 131: ...the record or single click the name then click C Quick Search by Patient ID 1 Be sure that the proper patient Database name appears in the window 2 Select Patient ID in the Category drop down list 3 B...

Page 132: ...ll the entries typed since the record was opened Figure 4 15 Existing Patient Demographics window 2 When you have finished updating the patient information DO NOT click right away Doing so will overwr...

Page 133: ...already in use a message will display indicating that the value is already in use Sex click the appropriate button Male or female must be chosen in order to automatically display Reference Charts on t...

Page 134: ...cquisition or results are not adjusted for height and weight Billing Information enter the patient s billing information Make any necessary notes Menopause Year if applicable enter the year menopause...

Page 135: ...oporosis Medications Technologist Physician and Referring Physician fields As an example the Osteoporosis Medications drop down list is reproduced here Osteoporosis Medications There are 3 ways to ent...

Page 136: ...rop Down List Field on page 4 30 for instructions Physician Select a Physician name from the drop down list or create a new name by clicking the Notepad button to enter or edit the Physician informati...

Page 137: ...Operator s Guide 437D140 Rev I Basic Operation 4 29...

Page 138: ...p down arrow that reveals a fully customized operator created list of names Clicking on the Notepad button allows the user to customize the list Full instructions follow To Add a Drop Down List Entry...

Page 139: ...or the replacement information in the box ex added drug name 4 Click Click The correction will now be included in the drop down list To Delete a Drop Down List Entry This feature is used to delete an...

Page 140: ...Drop Down List Manually This feature allows the operator to place a favorite entry at the top of the drop down list or anywhere else 1 Click on the Notepad button to open the dialog box 2 Select the...

Page 141: ...ed to the relevant chapter listed below for instructions on positioning and marking the patient and then performing the scan The following list provides links to those chapters Chapter 5 Scanning Whol...

Page 142: ...ensure consistent system operation 1 From the Database Navigator window click on File Exit to exit and close the Illuminatus software 2 Confirm that the software has been closed before performing the...

Page 143: ...interest The Whole Body scan requires the operator to mark the start and baseline points Intel ligent scanning i e scanning body edge to body edge is used to minimize scan time and to ensure the scan...

Page 144: ...ient Dose Note The radiation dose to the patient is dependent on the resolution filtration the scan speed used and the system configuration Dose values listed below are for any patient thickness Resol...

Page 145: ...t radionuclide uptake procedures Residual emission may be misinterpreted by Norland Bone Densitometers as x rays Screening patients for recent ingestion of radiopaque substances Barium or other dyes u...

Page 146: ...e removing the patient from the table and doing the Find Table Dimensions routine Caution Make certain the patient does not dangle their arm or hand over the riser while the scanner arm is moving duri...

Page 147: ...he center of the patient s head and press the button on the Scanner Arm Touch Pad MARKING THE END POINT Move the scanner arm over the patients abdomen Turn ON the laser Pos ition the laser dot at a po...

Page 148: ...not scan patients that may be pregnant or have had a recent radionuclide uptake pro cedure Update or Create the Patient s Record EXISTING PATIENT From the Database Navigator window double click on th...

Page 149: ...lick 4 The Parameters tab window opens Figure 5 3 The Whole Body Scan Parameters tab window 5 The scan parameters are shown in the bottom left hand side of the Parameters tab window and reproduced her...

Page 150: ...can parameters i e preferences see Preferences Whole Body Scan on page 3 26 If it is necessary to change the Speed Resolution parameter see Changing the Scan Parameters Prior to Scanning on page 11 75...

Page 151: ...ans Refer to the patient positioning photos and instructions in the Norland software Parameters tab window The steps and photos are reprinted in the manual for reference 1 Using the Scanner Arm Touch...

Page 152: ...positioning dot to make sure that the patient is within the scan window 8 The patient is now ready for scanning 9 Make the patient as comfortable as possible since movement during the scan will affec...

Page 153: ...G THE START POINT move the scanner arm until the laser positioning dot is approximately 1 cm above the top of the center of the patient s head and press The computer will emit a sound and the laser wi...

Page 154: ...between the lowest rib and the iliac crest see figure below This is the area of maximum soft tissue thickness Press the button 8 The computer will emit a sound and the laser will shut OFF 9 The dialo...

Page 155: ...n on page 11 37 for instructions on safely resuming the scan 1 Click 2 The Scan tab window displays the image as it develops shows how many lines will be scanned and gives an estimate of the total tim...

Page 156: ...QUALITY IS UNSATISFACTORY do one of the following Enter the appropriate number of scan lines in Extension of lines and click to include the entire region of interest OR click and remark the scan regi...

Page 157: ...esired OR ANALYZE NOW 1 Click 2 When the Analysis tab window opens cursors will be displayed in the regions of interest the chest pelvic area and each leg Note If this scan is not the initial scan use...

Page 158: ...If positioned correctly the pelvic cursor will completely surround the pelvis and contain a minimum of midriff leg and femoral neck tissue 6 Position the lower left leg cursor so that the left leg cur...

Page 159: ...Operator s Guide 437D140 Rev I Scanning Whole Body 5 17 Figure 5 4 Regions of Interest Whole Body Scan 7 Click The Results button will become available...

Page 160: ...issue Composition is enabled the Whole Body regions Total Fat Siri UWE Fat Brozek UWE Fat Soft Tissue Fat and TBMC FFM will also be displayed for the Total region Lean Mass and Fat Mass will be displa...

Page 161: ...Operator s Guide 437D140 Rev I Scanning Whole Body 5 19 or click to do another scan or click to end the process and return to the main window...

Page 162: ...Filmstrip View Click to highlight the thumbnail view of the scan 2 Click Tools Report Select Template or click the button to open the Report Con figuration dialog box 3 When the Report Configuration d...

Page 163: ...F file or a DICOM file and Close it 6 Click The Print window appears Select a printer select which pages to print and choose how many copies to print 7 Click to print the Report The Report is automati...

Page 164: ...A Sample Bone Exam Report A sample 2 page Bone Exam Report is included here for reference Figure 5 5 Page 1 of the Bone Exam Report Operator s Guide 437D140 Rev I 5 22 Scanning Whole Body...

Page 165: ...Operator s Guide 437D140 Rev I Scanning Whole Body 5 23 Figure 5 6 Page 2 of the Bone Exam Report...

Page 166: ...This page intentionally left blank Operator s Guide 437D140 Rev I 5 24...

Page 167: ...nd Small Subject scans It works in conjunction with the Whole Body Research and Small Subject scans to provide lean and fat soft tissue mass values in addition to the bone density values No additional...

Page 168: ...ater weighing requires that subjects be able and willing to be completely submerged in water while exhaling rather forcibly This method is ill suited for sub jects who are sick infirm unconscious or a...

Page 169: ...Subject Scan Specifications Total Body C V Head C V Trunk C V Abdomen C V Arms C V Legs C V Soft Tissue Mass 0 1 1 4 0 81 2 3 1 8 0 57 Lean Body Mass 0 93 1 4 1 6 2 6 2 3 1 5 Fat Mass 1 4 1 9 1 9 3 7...

Page 170: ...Measured Values Total Fat Total Fat Mass BMC LEAN FAT SIRI UWE Fat 4 95 Dt 4 142 100 Dt Total Density BROZEK UWE Fat 4 57 Dt 4 142 100 Dt Total Density Soft Tissue Fat Fat Mass Lean Fat TBMC FFM Tota...

Page 171: ...ed on the bottom of page 1 of the Whole Body Bone Exam Report that shows the classification of the patient according to the patient s Siri UWE fat percentage The chart displayed in the report is based...

Page 172: ...t Tissue values will be calculated for operator defined regions of interest see Special Region Cursors on page 11 38 After completing the scan perform the routine analysis see Analyzing the Scan on pa...

Page 173: ...is being viewed as a thumbnail in the Stamp View or the Filmstrip View Click to highlight the thumbnail view of the scan 2 Click Tools Report Select Template or click the button to open the Report Co...

Page 174: ...dow appears Select a printer select which pages to print and choose how many copies to print 7 Click to print the Report The Report is automatically saved and printed 8 Click 9 You are returned to the...

Page 175: ...rator s Guide 437D140 Rev I Soft Tissue Composition 6 9 A Sample Bone Exam Report A sample 2 page Bone Exam Report for a Soft Tissue Composition Whole Body Scan Figure 6 1 Page 1 of the Bone Exam Repo...

Page 176: ...Figure 6 2 Page 2 of the Bone Exam Report Operator s Guide 437D140 Rev I 6 10 Soft Tissue Composition...

Page 177: ...D140 Rev I Soft Tissue Composition 6 11 A Sample Body Composition Report A sample Body Composition Report for a Soft Tissue Composition Whole Body Scan with prior trending Figure 6 3 Page 1 of the Bod...

Page 178: ...Figure 6 4 Page 2 of the Body Composition Report Operator s Guide 437D140 Rev I 6 12 Soft Tissue Composition...

Page 179: ...L1 L2 L3 L4 segment which is analyzed for individual and total vertebrae The ana lysis will exclude transverse vertebral process areas from the bone mineral estim ations Figure 7 1 Patient positionin...

Page 180: ...Selectable High Precision 65mm sec Standard 130mm sec High Speed 260mm sec Table 7 1 AP Spine Scan Specifications Total L2 L4 C V Total L1 L4 C V Measure Scan Mode Measure Scan Speed BMD BMC AREA BMD...

Page 181: ...can based on the listed body thickness Patient Thickness cm High Precision Sv Standard Sv High Speed Sv 0 3 0 8 0 4 0 2 4 6 1 1 0 6 0 3 7 9 1 6 0 8 0 4 10 12 2 0 1 0 0 5 13 15 3 8 1 9 1 0 16 18 6 5 3...

Page 182: ...bstances Barium or other dyes used in some x ray procedures could result in increased soft tissue x ray absorption Screening patients for external opaque metal and plastic objects Jewelry buttons zipp...

Page 183: ...arm could result in an error message which will require removing the patient from the table and doing the Find Table Dimensions routine Caution Make certain the patient does not dangle their arm or ha...

Page 184: ...e laser dot is positioned 1 cm below the xiphoid process and then press the button on the Scanner Arm Touch Pad MARKING THE END POINT Move the scanner arm so that the laser dot is positioned 2 cm belo...

Page 185: ...ry to have the patient change to an examination gown or robe Shoes should also be removed Update or Create the Patient s Record EXISTING PATIENT From the Database Navigator window double click on the...

Page 186: ...e Scan Parameters 1 Click 2 Click AP Spine in the pop up window 3 Click 4 The Parameters tab window opens Figure 7 3 The AP Spine Scan Parameters tab window Operator s Guide 437D140 Rev I 7 8 Scanning...

Page 187: ...erences AP Spine Scan on page 3 23 For a full explanation of the AP Spine Scan parameters i e preferences see Preferences AP Spine Scan on page 3 23 If it is necessary to change the Speed Resolution A...

Page 188: ...scanner arm 1 Position the patient on the scanner table laying face up with their right side to the back rest Make sure the patient is centered and straight on the table Ensure that the patient s hips...

Page 189: ...elps to straighten the natural curvature in the spine and aids in separating the vertebrae 4 Ensure that the patient s hands are not in the scan area Place them at the patient s sides on the table 5 T...

Page 190: ...xiphoid point and press The computer will emit a sound and the laser will flash Note Click in the dialog box to re mark the Xiphoid Point Click at any time to abort the marking operation Caution Take...

Page 191: ...ING THE END POINT move the scanner arm until the dot is positioned 2 cm below the iliac crests see the figure below and press The computer will emit a sound and the laser will flash 5 The dialog box w...

Page 192: ...ill take a U shaped scan before it does the Measure scan Note If the U shaped scan is not successful the following alert box will be displayed In this case Norland recommends that the scan be terminat...

Page 193: ...g the scan Note To cancel the scan Click Lower the patient s legs by removing the AP Leg Rest Click Select in the dialog box Click Click Click Select AP Spine Return to Marking the Scan Region on page...

Page 194: ...terest You must extend the measurement scan to include the necessary landmarks in the region of interest 9 If necessary proceed to the steps in Unsatisfactory Measure Scan AP Spine on page 11 64 to re...

Page 195: ...alog box that pops up select the region to be analyzed Note Only use L2 L4 if L1 does not exist 3 When the Analysis tab window opens cursors will be displayed in the regions of interest Note Explanati...

Page 196: ...e spine is so compressed that the software can not automatically find the vertebral gaps the following dialog box will be displayed Click Continue 8 The Analysis tab window will refresh and add in two...

Page 197: ...Position cursors at the valleys of the histogram If patient has been scanned previously modify cursors to match the Comparison Image Right click on the image select Image Analysis Show Comparison See...

Page 198: ...Operator s Guide 437D140 Rev I 7 20 Scanning AP Spine...

Page 199: ...graphics window does not exist the Scan Results tab window will be displayed without a reference pop ulation graph The BMD of the first region of the Detailed Results will be plotted in the reference...

Page 200: ...nd Print a Report on page 7 24 or click to generate and print a report using a report template other than the default Proceed to Generate and Print a Report on page 7 24 or click to do another scan or...

Page 201: ...The patient s risk of fracture is plotted in the Reference Charts displayed in the Scan Results tab window Nor land incorporates the WHO World Health Organization criteria in plotting a patient s frac...

Page 202: ...ht the thumbnail view of the scan 2 Click Tools Report Select Template or click the button to open the Report Con figuration dialog box 3 When the Report Configuration dialog box opens click a Report...

Page 203: ...file or a DICOM file and Close it 6 Click The Print window appears Select a printer select which pages to print and choose how many copies to print 7 Click to print the Report The Report is automatic...

Page 204: ...A Sample Bone Exam Report A sample 2 page Bone Exam Report is included here for reference Figure 7 4 Page 1 of the Bone Exam Report Operator s Guide 437D140 Rev I 7 26 Scanning AP Spine...

Page 205: ...Operator s Guide 437D140 Rev I Scanning AP Spine 7 27 Figure 7 5 Page 2 of the Bone Exam Report...

Page 206: ...This page intentionally left blank Operator s Guide 437D140 Rev I 7 28...

Page 207: ...emur so that the femoral neck is in the analysis area The operator identifies the center of the femoral neck on the scout scan image then the Measure scan is taken Figure 8 1 Patient Positioning for t...

Page 208: ...Speed Selectable High Precision 45mm sec Standard 90mm sec Table 8 1 Detailed Hip Scan Specifications Femoral Neck C V Greater Trochanter C V Total Measure Scan Mode Measure Scan Speed BMD BMC AREA B...

Page 209: ...ess cm Entrance Dose Sv 0 7 0 1 8 10 0 2 11 13 0 2 14 16 0 3 17 19 0 5 20 22 0 9 23 25 1 7 25 2 6 Table 8 3 Scout Scan Skin Entrance Dose Patient Thickness cm High Precision Sv Standard Sv 0 7 1 7 0 9...

Page 210: ...orption Screening patients for external opaque metal and plastic objects Jewelry buttons zippers rivets buckles pens keys etc can affect the results if they are in the scanning region Screening patien...

Page 211: ...could result in an error message which will require removing the patient from the table and doing the Find Table Dimensions routine Caution Make certain the patient does not dangle their arm or hand...

Page 212: ...prosthetic device On the leg that will not be scanned gently pull the Velcro strap to the next reference number to rotate the hip Repeat the process on the leg that will be scanned Caution Caution th...

Page 213: ...sary to have the patient change to an examination gown or robe Shoes should also be removed Update or Create the Patient s Record EXISTING PATIENT From the Database Navigator window double click on th...

Page 214: ...lick Left Hip or Right Hip in the pop up window 3 Click 4 The Parameters tab window opens Figure 8 3 The Hip Scan Parameters tab window 5 The scan parameters are shown in the bottom left hand side of...

Page 215: ...Hip Scan parameters i e preferences see Preferences Hip Scan on page 3 24 If it is necessary to change the Speed or Width parameters see Changing the Scan Parameters Prior to Scanning on page 11 69 6...

Page 216: ...left hip will be scanned in this example Refer to the patient positioning photos and instructions in the Norland software in the Parameters tab window The steps and photos are reprinted in the manual...

Page 217: ...ner arm to a position above the patient s mid section Caution DO NOT position the scanner arm directly over the patient s face 3 Place the Hip Sling between the patient s legs and position as shown N...

Page 218: ...ort 5 Spread the patients feet and place the Leg Separator Block between the heels Note For the next step instruct the patient to relax their legs It is important that the rotation of the leg is a dir...

Page 219: ...ve any slack Hold the strap taut but do not rotate the leg Then secure the strap to the Velcro on top of the fixture 9 Notice that each Velcro strap is marked in increments consisting of letters and n...

Page 220: ...ack The patient must not help rotate the femur If they do improper and inconsistent positioning may result 12 Lift and pull the strap to rotate the leg a total of seven 7 marked increments on the stra...

Page 221: ...ensure that they will not be in the scan field 15 The patient is now ready for scanning 16 Make the patient as comfortable as possible since movement during the scan will affect the results The use of...

Page 222: ...oc ate the center of the Femoral Neck on the facing page Note FOR CLARIFICATION The typical default settings of the left and right hip Scout Scan regions are shown below Each scan region is centered a...

Page 223: ...l centimeters from the centerline of the femur anterior superior Pubic symphysis Imagine a transverse line across the pubic symphysis Ima gine another line down the center of the femur Place the laser...

Page 224: ...e the x ray exposure or stop the scanner arm movement Refer to Pressing the Emergency Stop Button on page 11 37 for instructions on safely resuming the scan 1 Click 2 The Scan tab window displays the...

Page 225: ...window and the Measure Scan button will become available 5 Determine whether the quality of the Scout Scan image is satisfactory or unsatisfactory 6 THE SCOUT SCAN IMAGE IS SATISFACTORY when the scan...

Page 226: ...imagine a line across the femoral neck as shown below and locate the center 9 Click on the target in the Scan window drag it to the middle of the femoral neck and release the mouse but ton to deposit...

Page 227: ...n safely resuming the scan 1 Click on 2 The Scan tab window displays the image as it develops shows how many lines will be scanned and gives an estimate of the total time remaining in the Measure scan...

Page 228: ...ill update the Scan tab window and the Analyze button will become available 5 If no further scans are to be performed remove the Hip Sling from the patient and help the patient up from the scanner tab...

Page 229: ...can data will be saved to the database for analysis at a later time The software will go back to the Parameter tab window You can do another type of scan if desired OR ANALYZE NOW 1 Click 2 When the A...

Page 230: ...e regions of interest are blatantly incorrect 5 If the patient has a prior scan use the Show Comparison feature to aid in positioning the cursors in a con sistent fashion Right click on the image sele...

Page 231: ...ursors by using the pointer to click on a con trol point Drag the cursor to its new location The neck cursor box should enclose the narrowest part of the neck To adjust the length of the femoral neck...

Page 232: ...image is not for diagnostic purposes If an exact match of the installed Reference Sets and the ethnic background entered into the Patient Demo graphics window does not exist the Scan Results tab windo...

Page 233: ...ault report template Proceed to Step 5 of Generate and Print a Report on page 7 24 or click to generate and print a report using a report template other than the default Proceed to Generate and Print...

Page 234: ...ference Charts displayed in the Scan Results tab window Nor land incorporates the WHO World Health Organization criteria in plotting a patient s fracture risk assessment See table below Note that this...

Page 235: ...a thumbnail in the Stamp View or the Filmstrip View Click to highlight the thumbnail view of the scan 2 Click Tools Report Select Template or click the button to open the Report Con figuration dialog...

Page 236: ...t window appears Select a printer select which pages to print and choose how many copies to print 7 Click to print the Report The Report is automatically saved and printed 8 Click 9 You are returned t...

Page 237: ...Operator s Guide 437D140 Rev I Scanning Hip 8 31 A Sample Bone Exam Report A sample 2 page Bone Exam Report is included here for reference Figure 8 5 Page 1 of the Bone Exam Report...

Page 238: ...Figure 8 6 Page 2 of the Bone Exam Report Operator s Guide 437D140 Rev I 8 32 Scanning Hip...

Page 239: ...animal or an inanimate object The Research Scan is typically used for animal scans anything from excised bones to whole body large rats to implants Figure 9 1 An example Research Scan image of the top...

Page 240: ...Any operator defined region within the scanner Active Scanning Window Scan Speed 1 0mm sec to 260mm sec Scan Width 2 x selected pixel size up to maximum scan width Scan Length 2 x selected pixel size...

Page 241: ...9 10 12 1 2 13 15 2 2 16 18 3 7 19 21 6 9 21 11 0 Table 9 4 Scout Scan Skin Entrance Dose Sv 60mm sec at 3 0mm x 3 0mm resolution Subject Thickness cm Entrance Dose Sv 0 3 1 3 4 6 1 8 7 9 2 7 10 12 3...

Page 242: ...g patients subjects for recent radionuclide uptake procedures Residual emission may be mis interpreted by Norland Bone Densitometers as x rays Screening patients subjects for recent ingestion of radio...

Page 243: ...the arm could result in an error message which will require removing the patient from the table and doing the Find Table Dimensions routine Caution Make certain the patient does not dangle their arm...

Page 244: ...ser dot at the start point and then press the button on the Scanner Arm Touch Pad MARKING THE END POINT Position the laser dot at the end point and press the button MARKING THE BASELINE POINT Position...

Page 245: ...e patient change to an examination gown or robe Shoes should also be removed Patients subjects should be checked for any metal or high density objects in the region of interest ROI that would affect b...

Page 246: ...bjects over two years of age Small Subject Software utilizes a fixed bone edge detection system that will trigger at a much lower level and is recommended for children under two years of age and for a...

Page 247: ...ng The default values are shown below To reset values to factory defaults see Preferences Research Small Subject Scan on page 3 28 For a full explanation of the Research and Small Subject Scan paramet...

Page 248: ...ed Research Small Subject scan area must lie within the scanner s active scan area Refer to the patient positioning photos and instructions in the Norland software Parameters tab window The steps and...

Page 249: ...sh 5 MARKING THE BASELINE POINT Position the scanner arm so that the laser positioning dot is over a point within the start and end points of maximum soft tissue no bone For objects which contain no s...

Page 250: ...ick 2 The Scan tab window displays the image as it develops shows how many lines will be scanned and gives an estimate of the total time remaining in the Scout scan 3 Monitor the image closely for any...

Page 251: ...a sound The software will update the Scan tab window and the Measure Scan button will become available 5 Using the click and drag method move the cursor box to define the area to be measured 6 If the...

Page 252: ...nd gives an estimate of the total time remaining in the Measure scan 3 Monitor the image closely for any indication of patient movement Cancel the scan immediately if the patient moves during the scan...

Page 253: ...do ONE of the following Enter the appropriate number of scan lines in Extension of lines and click to include the entire region of interest OR click and remark the scan region go to Marking the Scan...

Page 254: ...alysis tab window opens you will need to create and position Special Region Cursors to identify the regions of interest see Special Region Cursors on page 11 38 for full instructions Research Small Su...

Page 255: ...egions in accordance to the protocol Different protocols have different specifications 6 If the patient subject has a prior scan use the Show Comparison feature to aid in positioning the cursors in th...

Page 256: ...Scan Results The image will display with trending graphs to the right of the image The BMD in g cm2 BMC in grams and AREA in cm2 for each region of interest will be displayed below the graphs The leng...

Page 257: ...default report template Proceed to Step 5 of Generate and Print a Report on the next page or click to generate and print a report using a report template other than the default Proceed to Generate and...

Page 258: ...e thumbnail view of the scan 2 Click Tools Report Select Template or click the button to open the Report Con figuration dialog box 3 When the Report Configuration dialog box opens click a Report Templ...

Page 259: ...a PDF file or a DICOM file and Close it 6 Click The Print window appears Select a printer select which pages to print and choose how many copies to print 7 Click to print the Report The Report is auto...

Page 260: ...A Sample Bone Exam Report 1 Page Figure 9 3 A sample Bone Exam Report 1 Page for a Research Scan Operator s Guide 437D140 Rev I 9 22 Research Small Subject Scan...

Page 261: ...m above the lowest point of the rib cage and extend to 2 cm below the iliac crests along a center line that is approximately 10 cm anterior to the patient s back The operator visually confirms the com...

Page 262: ...Lateral Spine Scan Specifications Two Vertebra C V Single Vertebra C V Measure Scan Mode Measure Scan Speed BMD BMC AREA BMD BMC AREA High Precision 15mm sec 2 4 3 7 2 2 2 7 4 5 3 6 Standard 30mm sec...

Page 263: ...21 4 9 Table 10 3 Scout Scan Skin Entrance Dose Patient Thickness cm High Precision Sv Standard Sv High Speed Sv 0 7 5 1 2 6 1 3 8 10 7 3 3 7 1 8 11 13 10 7 5 4 2 7 14 16 13 3 6 7 3 3 17 19 25 3 12 7...

Page 264: ...uptake procedures Residual emission may be misinterpreted by Norland Bone Densitometers as x rays Screening patients for recent ingestion of radiopaque substances Barium or other dyes used in some x r...

Page 265: ...he arm could result in an error message which will require removing the patient from the table and doing the Find Table Dimensions routine Caution Make certain the patient does not dangle their arm or...

Page 266: ...MARKING THE START POINT Turn ON the laser Position the laser dot 2 cm above the lowest point of the rib cage and 7 cm to 10 cm anterior forward of the patient s back then press the button on the Scann...

Page 267: ...necessary to have the patient change to an examination gown or robe Shoes should also be removed Update or Create the Patient s Record EXISTING PATIENT From the Database Navigator window double click...

Page 268: ...eral Spine Scan Parameters tab window 5 The scan parameters are shown in the bottom left hand side of the Parameters tab window and reproduced here for reference Norland recommends that the factory de...

Page 269: ...page 3 27 For a full explanation of the Lateral Spine Scan parameters i e preferences see Preferences Lateral Spine Scan on page 3 27 If it is necessary to change the Speed or Measure on Axis paramete...

Page 270: ...ock the Rib Cage Support block 2 Lateral Limb Support blocks and a Head Roll Have these pos itioning aids readily available before positioning the patient for the Lateral Spine scan 1 Use the Scanner...

Page 271: ...e ribs are supported by the Rib Cage Support block but not elevated 7 Use the AP Spine Leg Rest block to draw the knees forward to form a 135 angle between the spine and the thigh The hips should rema...

Page 272: ...vertical plane with arms at 90 10 The patient is now ready for scanning 11 Make the patient as comfortable as possible since movement during the scan will affect the results The use of a sheet or ligh...

Page 273: ...the patient s midsection along this imaginary axis Figure 10 4 Typical Lateral Spine Scout Scan region Note Explanation The typical Lateral Spine Scout scan region is from mid L1 to the iliac crest e...

Page 274: ...e mark the Start Point Click at any time to abort the marking operation 6 MARKING THE END POINT E move the scanner arm until the dot is about 2 cm below the iliac crest and press The computer will emi...

Page 275: ...Operator s Guide 437D140 Rev I Scanning Lateral Spine 10 15 8 The computer will emit a sound and the laser will flash 9 The dialog box will automatically close when the marking tasks are complete...

Page 276: ...x ray exposure or stop the scanner arm movement Refer to Pressing the Emergency Stop Button on page 11 37 for instructions on safely resuming the scan 1 Click 2 The Scan tab window displays the image...

Page 277: ...he image of the lumbar segment in the scan is straight Since the factory setting for the Measurement on Axis is set to ON by default enabled the lumbar segment image must be straight so that the Measu...

Page 278: ...to just touch the anterior edge of L3 L2 L3 or L3 L4 Position the cursor box to include portions of the adjoining vertebra above and below the two vertebrae being measured Position the center line of...

Page 279: ...Click on 2 The Scan tab window displays the image as it develops shows how many lines will be scanned and gives an estimate of the total time remaining in the Measure scan Note Always allow the Measu...

Page 280: ...S NOT SATISFACTORY do one of the following Enter the appropriate number of scan lines in Extension of lines and click to include the entire region of interest OR click and remark the scan region see M...

Page 281: ...can later The scan data will be saved to the database for analysis at a later time The software will go back to the Parameter tab window You can do another type of scan if desired OR ANALYZE NOW 1 Cli...

Page 282: ...ust above and behind the upper vertebra to be analyzed 5 Position the lower left control point inside the vertebral notch below and behind the lower vertebra to be ana lyzed The figure below shows the...

Page 283: ...r box that will contain each vertebra being analyzed with a minimum of soft tissue Note Norland strongly recommends using the computer generated analysis unless the regions of interest are blatantly i...

Page 284: ...ae If the patient has been scanned before the values for Short Term and Long Term will also be displayed Their definitions are given in the following table SHORT TERM CHANGE Ratio of change between cu...

Page 285: ...fault report template Proceed to Step 5 of Generate and Print a Report on the next page or click to generate and print a report using a report template other than the default Proceed to Generate and P...

Page 286: ...the thumbnail view of the scan 2 Click Tools Report Select Template or click the button to open the Report Con figuration dialog box 3 When the Report Configuration dialog box opens click a Report Tem...

Page 287: ...PDF file or a DICOM file and Close it 6 Click The Print window appears Select a printer select which pages to print and choose how many copies to print 7 Click to print the Report The Report is automa...

Page 288: ...A Sample Bone Exam Report A sample 2 page Bone Exam Report is included here for reference Figure 10 5 Page 1 of the Bone Exam Report Operator s Guide 437D140 Rev I 10 28 Scanning Lateral Spine...

Page 289: ...Operator s Guide 437D140 Rev I Scanning Lateral Spine 10 29 Figure 10 6 Page 2 of the Bone Exam Report...

Page 290: ...This page intentionally left blank Operator s Guide 437D140 Rev I 10 30...

Page 291: ...Adding Audio to a Patient Record 11 2 Using the Voice Note Option 11 3 Using the Audio Dictation Option 11 5 How to Export a Report to PDF 11 7 FolderMAIL 11 9 Database Management 11 14 Working with...

Page 292: ...ft An Audio Dictation is spoken information that is usually associated with the visit The dictation is stored in a separate Audio Dictations tab as seen in the figure to the right Figure 11 1 Voice No...

Page 293: ...before starting this procedure 2 Click to highlight the scan that you want to add a Voice Note to 3 Right click the mouse over the scan to open the menu Note RECORDING BEGINS IMMEDIATELY in the next s...

Page 294: ...on to play the audio clip How to Delete a Voice Note 1 Click to highlight the image where the Voice Note is attached 2 Right click to open the menu and select Remove Voice Note 3 The following window...

Page 295: ...for viewing and listening Overview of the Audio Dictation Buttons The following image describes the Audio Player dialog box buttons When an Audio Dictation file is saved by clicking the button it is...

Page 296: ...recording The audio dialog box closes and the recording is saved 7 Notice the addition of a new tab labeled Audio Dictations Click the tab to see this view How to Play Back or Add to a Recording 1 Dou...

Page 297: ...ently delete the audio dictation 1 Select the Audio Dictation tab 2 Click to select the blue Audio icon the background should turn red 3 Right click the mouse over the recording to open the menu Selec...

Page 298: ...elect Template or click the button select a new report style and click 4 Select one or two scans depending on your report type and click 5 Complete any optional fields in the report preview window 6 C...

Page 299: ...AIL file includes all the DXA scans selected for that visit date the patient demographic data any reports and any audio dictations associated with that visit Requirements To use the FolderMAIL feature...

Page 300: ...d Names to the Address Book on page 11 12 for reference if neces sary If FolderMail is not active refer to Troubleshooting FolderMAIL on page 16 9 4 Fill in the email Subject and body text to be inclu...

Page 301: ...Operator s Guide 437D140 Rev I Additional Techniques 11 11 6 The dialog box closes and the file is sent...

Page 302: ...on Type the recipients e mail address in the box Press the Enter key when done 3 Type in the name to display for this e mail recipient Press the Enter key when done 4 Notice than the recipients name n...

Page 303: ...the attachment file names 3 From the Database Navigator window select the Database name where you want to place the imported patient FolderMAIL file 4 Click File Import FolderMail to open the followi...

Page 304: ...ands and procedures are discussed at length in this section Creating a Database Folder 11 15 Active Database Remove From List 11 16 Active Database Add to List 11 17 Importing a Database 11 18 Exporti...

Page 305: ...n the Database Navigator win dow 1 Click File Database Create 2 Type in a name for the new database folder New Study Database was used in this example 3 Click The following window pops up confirming t...

Page 306: ...w The database will however remain on the hard drive 1 Click File Database Active Database Remove From List 2 Click the drop down arrow to view all the Databases in the list and select the Database fo...

Page 307: ...indows based software The Add to List command is used when the Database of interest was previously removed from the drop down list but not deleted from the hard drive and the operator wants to restore...

Page 308: ...to or type the location of the files to be imported into the box labeled Database In this example the path F Exported Scans is used All the files in that location are now listed in the window 4 To imp...

Page 309: ...Operator s Guide 437D140 Rev I Additional Techniques 11 19 6 When complete click 7 The imported patient scans now appear in the Database selected in step 1...

Page 310: ...ate of interest under the patient s name Hold the Shift key and click the consecutive names of the patients you want to export Hold the Ctrl key and click only the patient names you want to export in...

Page 311: ...Database window along with the visit dates selected multiple names appear if more that one name was selected 9 Click to return to the Database Navigator window Note For subsequent export procedures y...

Page 312: ...all the associated scan data files that go with that patient Deletions cannot be undone 1 Select the patient from the Patient Visit List to be deleted Only one patient can be deleted at a time 2 Clic...

Page 313: ...files that go with that visit Deletions cannot be undone 1 Click on the patient s visit scan date in the Database Navigator window that is to be deleted 2 Click the button at the bottom of the window...

Page 314: ...can image to be deleted i e select the Patient Name Visit Date and Scan Type 2 Click on to open the Scans tab window 3 Highlight the scan or scans to be deleted Hold the Ctrl key to select more than o...

Page 315: ...Operator s Guide 437D140 Rev I Additional Techniques 11 25 6 Click on to delete the scan s remember there is NO undo 7 The selected scan will be deleted from the database...

Page 316: ...Chapter 18 Reference Data Sets Chapter 18 also describes the source of the data and explains the information gathering cri teria The Reference Sets window shown below displays a list of currently avai...

Page 317: ...ference sets for multiple user defined regions for a given scan type Also for the same scan type and region name multiple reference sets can be created with different titles In the case of the Small S...

Page 318: ...s being created for patients younger than twenty years old The Title entered in the box will appear at the top of the Reference Graph A sample Reference Set is reproduced below for reference 6 Click a...

Page 319: ...ference Set file to the current Refer ence Set file 1 Click on File Reference Sets to open the Reference Sets window 2 Click on to open the file selection window 3 Specify the file that the Reference...

Page 320: ...multiple References press the Ctrl key to highlight the desired References and click or d to select a group of References click on the first desired Reference press Shift and click on the last to hig...

Page 321: ...window 1 Click on File Reference Sets to open the Reference Sets window 2 Highlight the Reference Set to be edited then right click on it 3 Click Edit 4 When the Edit window opens make the necessary...

Page 322: ...k to highlight the Reference Set s to be deleted To select an individual Reference Set click on it To select multiple References press the Ctrl key and click on the desired References To select a grou...

Page 323: ...ocate and click to highlight the Reference Set s to be sent To select an individual Reference Set click on it To select multiple References press the Ctrl key and click on the desired References To se...

Page 324: ...File Tools 2 Click on the Normals tab 3 To print one Reference Set click on the Reference Set of interest to select it and then click on the Print Selected button 4 To print all the Sets click on the...

Page 325: ...rompted to select which reference sets are used The user may then select any of the available reference sets available for the scan type by clicking on it and then clicking Click if no reference sets...

Page 326: ...Operator s Guide 437D140 Rev I 11 36 Additional Techniques...

Page 327: ...st the Emergency Stop switch to release it then turn the scanner power switch OFF and back ON again to resume scanning Caution When the scanner power switch is turned back on the scanner arm will retu...

Page 328: ...on feature to aid in replication of any special region cursors Number of Special Regions Permitted The maximum number of special regions permitted depends on the scan type The table below lists the ma...

Page 329: ...Sides is selected here 4 Sides Side Control Cursor is the original on axis rectangular area defined with side placement It is commonly used for regular on axis areas or areas that need dimensions to...

Page 330: ...ll not list Length and Width values 7 The Length and Width values will update as control points are adjusted 8 The cursor can be modified as any other cursor Click on any point inside the cursor and d...

Page 331: ...1 41 Modify an Existing Special Region 1 In the Scan Results window right click to open the menu shown below 2 Select Image Analysis Modify Region 3 Click on the border of the region needing to be mod...

Page 332: ...you are satisfied with the cursor box size and placement for the modified region 6 To modify another region click on the border of the next region to enable it and modify the region as needed 7 Click...

Page 333: ...Rev I Additional Techniques 11 43 Delete a Special Region 1 In the Scan Results window right click to open the menu shown below 2 Select Image Analysis Modify Region 3 Click on the border of the regi...

Page 334: ...age Analysis Modify Region 3 In the list of regions highlight the region to be renamed 4 Click 5 In the Region Details window type a new name for the Region in the Region Name box 6 Click Click The ne...

Page 335: ...ation performed in order to obtain meaningful serial analyses Include The Include function allows the operator to include odd shaped islands of the scan which did not contribute to BMD results as bone...

Page 336: ...ge of the include box left hand picture and drag it to the general area to be included Use the click and drag method to position the cursors around the artifact to be included middle pic ture Operator...

Page 337: ...an irregularly shaped artifact make the size of the include box small Drag it so it covers a part of the artifact then click on Continue Repeat with another small box Continue this incremental includ...

Page 338: ...10 The scan is saved and the Filmstrip view appears showing the newly included region in the thumbnail to the left Operator s Guide 437D140 Rev I 11 48 Additional Techniques...

Page 339: ...t such as buttons or zippers are included in the scan region it is better to re scan the patient after removing the object Using the Exclude function deletes underlying or superior tissue values in th...

Page 340: ...ved from the image right hand picture 6 Repeat steps 3 4 and 5 to define additional regions to be excluded 7 To exclude an irregularly shaped artifact make the size of the exclude box small Drag it so...

Page 341: ...s Guide 437D140 Rev I Additional Techniques 11 51 9 Data within the excluded region is removed from the results calculations The DXA software stores the excluded region information with the scan analy...

Page 342: ...ng linear measurements of anatomical features 1 In the Scan Results window right click to open the menu shown below Select Image Analysis Ruler Tool 2 The Ruler Tool will display on the scan with curs...

Page 343: ...nd drag one end of the ruler to the place being measured 4 Click and drag the other end of the ruler to the final position and release The measured length will be dis played in millimeters in the wind...

Page 344: ...rate trending res ults 1 From the Scan Results window right click over the scan image to open the menu Select Image Analysis Show Comparison 2 The image of the patient s first scan of the same type is...

Page 345: ...match the comparison image 4 It will be necessary to rescan if the current scan doesn t match the patient s initial scan 5 Once positioned click to display the scan results or right click and deselec...

Page 346: ...terms of the non bone tissue value of each point Composite Default setting for Whole Body scans that provides a low energy attenuation image similar in appearance to an x ray film image Fat Provides...

Page 347: ...one edges Sqrt Denotes a square root scaling of the data points and is similar to Log The system retains the current Image Mode and Image Composition settings while scans created during the same visit...

Page 348: ...Tools Report View Selected to regenerate the report with the selected image mode See Scan Reports on page 2 12 for more details on viewing reports Operator s Guide 437D140 Rev I 11 58 Additional Techn...

Page 349: ...types of scans 1 Locate the patient s name or ID in the Database Navigator window containing the scan that you want to analyze 2 For unanalyzed scans the word No appears in the column labeled Analyzed...

Page 350: ...ed on your scan type AP Spine scan see Analyzing the Scan on page 7 17 Hip scan see Analyzing the Scan on page 8 23 Lateral Spine scan see Analyzing the Scan on page 10 21 Whole Body scan see Analyzin...

Page 351: ...lected Scout Scan studies can not be processed by Reanalyze Note If a series of scans are to be Reanalyzed it is important to reanalyze the patient s initial scan first This will establish new baseli...

Page 352: ...n results but can be updated if they were entered incorrectly for a scan 1 Select a scan on the Stamp View or Filmstrip view 2 Right click on the selected scan and select Properties 3 Update the Heigh...

Page 353: ...e Settings Speed mm sec 65 130 260 Resolution mm 1 0x1 0 1 5x1 5 Auto Centering On Off Mark On Axis On Off Default settings Table 11 2 AP Spine Scan Settings Note If scan parameter changes are made pr...

Page 354: ...arm will not hit the patient with the extended scan length then click 2 OR you can click and hold on the control points to extend the top of the scan area to include L1 Then click on to rescan the new...

Page 355: ...eposition and remark the patient If automatic centering was not successful the original start and end points would be used for the Measure scan and the following warning message will display The origi...

Page 356: ...t orientation It will not straighten scoliotic spines Note To achieve the highest quality Spine scans this feature should be DISABLED Figure 11 4 illustrates an example of a scan with the Force Mark P...

Page 357: ...gaps 1 During the Analysis phase of the AP Spine Scan right click over the scanned image to open the menu Select Image Analysis Analysis Options 2 Click on Angulated in the Scanner Preferences window...

Page 358: ...Viewing the Scan Results Tab on page 7 21 6 Regions of interest L1 L2 L3 L4 L2 L4 L1 L4 will be compared to reference populations which did not include studies with scoliotic spines Operator s Guide...

Page 359: ...ue from the drop down list Note that the Measure Scan width will also change Setting Available Settings Speed mm sec 45 90 Width cm Scout 12 cm Measure 9 cm Scout 16 cm Measure 12 cm Default settings...

Page 360: ...rag the target cursor to the middle of the femoral neck If the femoral neck is not visible you may reposition the scout box at any location closer to the neck region 2 Caution the patient to lie still...

Page 361: ...image appears to have missing areas of bone then the Alternate R Value option should be disabled and the scan reanalyzed Changing the Alternate R Value option can make a large difference in the T Scor...

Page 362: ...the filmstrip view Click Image Analysis Analysis Options 2 Uncheck the box for Alternate R Value Analysis Click on 3 When the Analysis tab window opens place the target cursor in the middle of the fem...

Page 363: ...ick If the automatic computer analysis is successful the software will construct a cursor box and the Results button will become available 5 Click 6 The proper analysis will include all areas of bone...

Page 364: ...ysis To Convert a Scan 1 Locate the patient s name in the Database Navigator and select the visit which contains the Comac ana lyzed scans 2 Click 3 Double click on the Comac analyzed scan to display...

Page 365: ...4 5 mm x 9 0 mm 260 mm s 4 5 mm x 9 0 mm 130 mm s 2 8 mm x 7 8 mm 200 mm s 2 8 mm x 7 8 mm 100 mm s Default setting Table 11 4 Whole Body Scan Settings Note If scan parameter changes are made prior t...

Page 366: ...asure 10 0 User Defined Measure on Axis On Off Default settings Table 11 5 Lateral Spine Scan Settings Note If scan parameter changes are made prior to scanning they will only apply to the current sca...

Page 367: ...ess Before beginning the Scout scan you must first disable the Measurement on Axis feature set to OFF 1 From the Scan tab window click on 2 At the Cancel Scan window select Discard and click OK 3 To r...

Page 368: ...l Note If scan parameter changes are made prior to scanning they will only apply to the current scan being acquired To save the changes as defaults for all scans or to revert to the default values Cli...

Page 369: ...Note that for patients that have a much lower BMI less than 20 the actual Ten Year Fracture Risk may be greater than calculated The Ten Year Fracture Risk feature provides a Ten Year Hip Fracture Ris...

Page 370: ...how to enter patient information The following items must be entered to create a Ten Year Fracture Risk assessment Sex Ethnicity Date of Birth Fracture Risk Questionnaire The button opens the Ten Year...

Page 371: ...sented by Sweden and US High risk is represented by the UK and Italy Moderate risk is represented by China Spain France and Japan Low risk is represented by Turkey Risk Factors Risk Factors are classi...

Page 372: ...in a grading as a Moderate Risk Indicator Current Smoking A report of current smoking is considered an indicator of risk A positive response is graded as a Low Risk Indicator Alcohol Use of 3 or More...

Page 373: ...that all the information listed is correct otherwise a possible misdiagnosis could be made The information is grouped into three separate sections Demographic Information this includes the patient nam...

Page 374: ...port template must be set to Ten Year Fracture Risk Report prior to performing the scan To generate a report for a scan that was previously analyzed and saved 1 Make sure that the scanned image is bei...

Page 375: ...port Template will remain the default until it is changed The currently selected Report Template is always displayed at the bottom of the IlluminatusDXA window 4 Click Tools Report Generate New or cli...

Page 376: ...Report The Report is automatically saved and printed 8 Click 9 You are returned to the Filmstrip view screen The saved Report can be found under the Reports tab The Report can be viewed modified and...

Page 377: ...Operator s Guide 437D140 Rev I Ten Year Fracture Risk 12 9 A Sample Ten Year Fracture Risk Report A sample Ten Year Fracture Risk Report Figure 12 1 Page 1 of the Ten Year Fracture Risk Report...

Page 378: ...Figure 12 2 Page 1 of the Ten Year Fracture Risk Report Operator s Guide 437D140 Rev I 12 10 Ten Year Fracture Risk...

Page 379: ...ery or print medical images and derived structured documents as well as to manage related workflow The Illuminatus DXA DICOM interface supports the first 3 items above namely pro ducing and sending of...

Page 380: ...us DXA computer must be connected to a network and have a valid IP Address assigned in Win dows OAC Code An OAC code is required to enable the DICOM software in Illuminatus DXA Refer to Scanner Prefer...

Page 381: ...Interface How to Invoke the DICOM Interface In the Database Navigator window click Tools DICOM Interface The Illuminatus DICOM files window will appear and will show the DICOM files that have been pr...

Page 382: ...Network Administrator The Delete DICOM File after Successful Transfer check box indicates whether or not you would like the DICOM interface to automatically delete DICOM files after they have been su...

Page 383: ...e fields in this section will become enabled for editing The Local AE Title should not be changed unless instructed by your Network Administrator The Retrieval Limit indicates the maximum number of re...

Page 384: ...SCP The Port is the port of the remote SCP in which data is transferred to The Type indicates whether the destination device is an Archive Server Workstation or Print Server These choices are availab...

Page 385: ...vice 1 Device Not Responding 2 Device Responding Compression Supported 3 Device Responding Compression Not Supported Once you have configured your DICOM Devices you can begin exporting the DICOM repor...

Page 386: ...alue will default to OT Other To change the Modality value to be used on all reports edit the file Preferences ini in the IlluminatusDXA software installation folder Search for the setting DefaultModa...

Page 387: ...ed at the bottom of the window You may click the Save All button to save all worklist results to your patient database or highlight one or more entries and click Save Exporting and Pushing DICOM Repor...

Page 388: ...ed you may enter additional parameters and click Query again to refine your search To save the Parameters as defaults the next time the Worklist window is opened click the Used saved search values box...

Page 389: ...urn an error code to the user as shown in Figure 13 7 above right If the Worklist Query cannot be performed the user may not be able to retrieve the patient information from the Worklist server and th...

Page 390: ...ected before saving any results If the patient record already exists and the Patient Name ID Date of Birth and Sex all match no changes will be made to the patient record If these values are different...

Page 391: ...ith the information from the worklist data Only the Name Date of Birth and Sex will be modified All other patient demographic information will not be modified If multiple query results are selected to...

Page 392: ...n will be visible and enabled as shown in Figure 13 10 Figure 13 10 The Export DICOM button The button will create a DICOM file in the DICOM folder configured in Advanced Preferences typically C Illum...

Page 393: ...M Files dialog box appears they may perform several operations The system will allow the user to select one or more entries from the Illuminatus Patient DICOM Files listing To select more than one ite...

Page 394: ...e up the selected items and set their destination to the configured device 3 Multiple Devices Configured If multiple devices are configured the system will display a dialog listing the devices configu...

Page 395: ...e user The Delete Operation When the user presses the button the system will confirm that the selected files are to be deleted as shown in Figure 13 14 If the user presses the files will be deleted If...

Page 396: ...minatus DICOM Job Queue The user may press the Refresh button to manually refresh the DICOM queue If the user selects one or more files in the lluminatus DICOM Job Queue dialog box the Delete button b...

Page 397: ...is not recommended for use by untrained users DB Extract merely creates a data file that may be safely manipulated by third party programs No other use is intended or recommended An understanding of...

Page 398: ...ct If the system has any special features such as Soft Tissue Composition the scan ner must be turned on prior to starting the DB Extract program to enable them After the program is opened the DB Extr...

Page 399: ...he data is to be exported from Databases may be selected by clicking on the drop down arrow and selecting the database If the database desired is not in the list the database may be added by clicking...

Page 400: ...Single parameters may be added by double clicking on the selected item or clicking on the desired item then clicking Multiple items may be added in one of two ways To add items that are grouped togeth...

Page 401: ...less of scan type To export only patients whose name or ID number contains specific characters enter the characters in the provided box Multiple values must be separated by a comma For example to expo...

Page 402: ...en select the day If no dates are entered the default date of 1 1 1900 is displayed patients will be exported regardless of scan date If only a start date is entered patients who were scanned after th...

Page 403: ...tracks how many patients receive hip scans every six months Rather than having to enter the parameters each time the tracking is done a setup file could be created that automatically loads the paramet...

Page 404: ...the export is being made An export could take as long as an hour for very large 20 000 patient databases depending on the number of parameters that are to be exported Once the export has begun it can...

Page 405: ...Patient Address Address Patient s Street Address Patient City City Patient s City Patient State State Patient s State Patient Zip Code Zip_Code Patient s Zip Code Patient Date of Birth Birth_Date Pat...

Page 406: ...Visit Visit Medications Medications Patient Medications on the Date of the Visit Visit Study Phys ician Study_Physician Patient s Physician on the Date of the Visit Visit Referring Phys ician Study_Re...

Page 407: ...can Type Scan_Type Text Identifying the Scan Type Spine AP Spine scan Lat Spine Lateral Spine scan Left Hip Left Hip scan Right Hip Right Hip scan Body Original Whole Body scan DF Body Whole Body with...

Page 408: ...A scan 22 Scoliatic AP Spine scan Scan Analysis Flags Analysis_ Flags Analysis flags enabled for the scan Manual Cursors Soft Tissue Correction Regional R Analysis Fat Mass Adjustment Extreme Points S...

Page 409: ...L4 Lateral Spine L4 Vertebra fem neck Hip Femoral Neck troch Hip Trochanter wards tri Hip Wards Area fem shaft Hip Femoral Shaft distal Distal R U Forearm site proximal Proximal R U Forearm site d rad...

Page 410: ...ral Spine L3 Vertebra 18 Lateral Spine L4 Vertebra 19 Lateral Spine L2 Vertebra 20 Distal R U Forearm site 21 Proximal R U Forearm site 22 Distal Radius Forearm site 23 Proximal Radius Forearm site Re...

Page 411: ...up to ten regions exported x denotes the region number Displayed in Source List As Displayed in Exported File As Description Region FatMass Region x FatMass Fat g Region LeanMass Region x LeanMass Lea...

Page 412: ...This page intentionally left blank Operator s Guide 437D140 Rev I 14 16...

Page 413: ...d systems Norland will make available service documentation upon request to those qualified technicians who have received Norland service training Neither the x ray source nor the laser positioning ai...

Page 414: ...pad can be cleaned with a damp cloth or a mild cleaner such as Windex Other cleaners may be too abras ive Do not use any product containing bleach Note If the Table Top pad is removed for cleaning mak...

Page 415: ...ocess does not apply to any other versions of Windows To configure the backup refer to Configuring Backup for Win dows 10 on page 3 5 TO BEGIN THE SYSTEM BACK UP MANUALLY Exit the Illuminatus software...

Page 416: ...ows To configure the backup refer to Con figuring Backup for Windows 7 on page 3 6 TO BEGIN THE SYSTEM BACK UP MANUALLY Exit the Illuminatus software to the Windows desktop Insert the USB flash drive...

Page 417: ...on Other problems can usually be resolved by shutting down and restarting Whenever further repairs are needed contact the local Norland Technical Support number Performing Multiple QC Phantom Scans Sc...

Page 418: ...m is straight by using the arrow buttons to move the laser to the dot marked D Re position the Phantom if it is not straight Move the laser back to the dot marked C 3 Press to mark point C 4 As soon a...

Page 419: ...isplay to notify operator of current con dition or status Sometimes these messages will be accompanied by a suggested action This section will assist in overcoming those not so obvious situations This...

Page 420: ...ner is plugged into the power strip verify the power strip is turned on and the light is on Verify there is power to the outlet Verify the Emergency Stop button has not been activated Twist the button...

Page 421: ...into a live outlet Turn the scanner and computer off wait 10 seconds turn them back on and retry In the Database Navigator window select Tools Initialize Scanner to see if the arm will move to home po...

Page 422: ...the program may be running at a time If another instance of the program is not currently running click Yes to restart the Illu minatusDXA program Time date display incorrect Right click on the time in...

Page 423: ...were not suc cessfully imported Verify the import source directory contains all necessary data files and patient directories Perform XFCHECK on the data from the GEM computer to verify the data is fr...

Page 424: ...ced in the correct calibration area Verify points A and B were marked in the correct order and on the X in the Plexiglas of the calibration standard Turn off the scanner and computer and repeat the ca...

Page 425: ...r on the scanner and retry the calibration If the problem occurs again contact Technical Support Calibration Faults continued Printer Condition Action Printer excessively loud Check to ensure the prin...

Page 426: ...g Ethnic group for the specific regions being graphed or it has not been entered in the Patient Demographics window The Reference Set is disabled Enable the Reference Set using the File Refer ence Set...

Page 427: ...The calculated value requires more than five digits The Reference Set does not contain information for a full age range Reference Trend Charts continued Height and Weight on Reports Condition Action...

Page 428: ...This page intentionally left blank Operator s Guide 437D140 Rev I 16 10...

Page 429: ...d in this chapter This chapter discusses the following Norland Bone Densitometer System Specifications 17 2 Technical Description 17 4 Cautions 17 13 Label Locations 17 17 Scanner Labels 17 19 Control...

Page 430: ...solated Multiple Port able Socket Outlet IMPSO device if it was sup plied with the scanner This includes the processor monitor printer and any external backup devices The IMPSO must be plugged dir ect...

Page 431: ...ble Hip Line Spacing 1 0mm Point Resolution 1 0mm Whole Body Line Spacing 13 0mm 9 0mm and 7 8mm selectable Point Resolution 6 5mm 4 5mm and 2 8mm selectable Lateral Spine Line Spacing 1 0mm Point Res...

Page 432: ...wered from the isolated multiple portable socket outlet IMPSO device provided with the system Focal Spot to Image Receptor Distance SID The SID is equal to 765mm It is fixed and the operator does not...

Page 433: ...ng Connect only items that have been specified to be part of or compatible with this Medical Electrical ME system Unit should be installed in such a way that the operator can achieve optimum use of it...

Page 434: ...sed to connect the computer to the scanner to minimize the possibility of adverse EMC effects Using a different cable could result in increased emissions and or decreased immunity Required per clause...

Page 435: ...ommon mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage Dips Short Interruptions and voltage variations on power s...

Page 436: ...omagnetic site survey should be less than the compliance levelin each frequency range Interference may occur in the vicinity of equip ment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz...

Page 437: ...According To Frequency Of Transmitter m Rated maximum power output of the transmitter W 150 kHz to 80 MHz d 1 2 P1 2 80 MHz to 800 MHz d 1 2 P1 2 800 MHz to 2 5 GHz d 2 3 P1 2 0 01 0 12 0 12 0 23 0 1...

Page 438: ...eck for the hip scan It is easy to use and reduces the negative effect of not having the femur neck perpendicular to the x ray beam Daily Calibration The operator is prompted to do a calibration at th...

Page 439: ...mm T 3 15A 250V 5mm X 20mm T Table 17 5 Fuse Ratings Beam Quality Information Item Equivalent Filtrationa Notes Half Value Layer HVL 6 6mmAl Tested at 100 kV 1 3 mA Irremovable Materials 1 9mmAl Teste...

Page 440: ...s located under the scanner arm It may be located in any position under the arm The exact loc ation can be identified by activating the laser Figure 17 1 Possible X ray Beam Location Operator s Guide...

Page 441: ...tient equalization terminal not provided Caution The laser within this product is not user serviceable In the event it fails to operate contact Norland Technical Support Caution Use of controls or adj...

Page 442: ...IMPSO provided with this ME system is 300 VA for 115 230 Vac at 50 60 Hz Warning If another IMPSO is used verify its electrical rating is adequate for the computer com ponents plugged into it Caution...

Page 443: ...o the source A laser is used for marking the area of the patient to be scanned Do not allow the beam to hit the patient s eyes and be careful that it does not reflect off shiny surfaces The only opera...

Page 444: ...ile scanning a 20 x 30 x 15 cm water phantom A Victoreen Model 450P Ion Chamber 300 cc was used to measure the radiation levels at approximately one foot and three feet from the beam The 450P had a cu...

Page 445: ...Operator s Guide 437D140 Rev I Technical Reference 17 17 Label Locations Scanner Front View Scanner Back View Continued on the next page...

Page 446: ...Label Locations continued Operator s Guide 437D140 Rev I 17 18 Technical Reference...

Page 447: ...19 Scanner Labels Identification Label The scanner Model is designated by the name ELITE The part number 437A150 is also on the label Located on the outside of the shipping container If applicable If...

Page 448: ...Scanner Labels continued Operator s Guide 437D140 Rev I 17 20 Technical Reference...

Page 449: ...Operator s Guide 437D140 Rev I Technical Reference 17 21 Scanner Labels continued...

Page 450: ...ffixed to the Power Entry Module located inside the scanner table Tube Housing and High Voltage Generator Labels The label below is affixed to the Norland combination tube housing and high voltage gen...

Page 451: ...ers at the end of the chapter This chapter discusses the following Data Collection Sites 18 2 Data Gathering Process 18 2 Medical History Form Review Criteria 18 3 Excerpt from Calcified Tissue Intern...

Page 452: ...tory forms and verified by Norland selected investigators Categories included height weight ancestry ethnicity occupation diet family history medical and surgical history and so forth Ethnic indi vidu...

Page 453: ...s means number of pregnancies Broken Fractured Hip Not grounds for exclusion if occurred more than five years prior to data collection Cancer Subject data may be included as long as subject has been c...

Page 454: ...six 6 months will be excluded For those with a past history please note med ication duration dose and time frame on Medical History form Calcitonins Calcitonins are grounds for exclusion Individuals...

Page 455: ...using step wise deletion of regression break points The standard deviation was fitted to the curves forcing the standard deviations to be equal at the breakpoints but allowing the standard deviation t...

Page 456: ...ed values or color versus black and white reports Figure 18 1 Fracture Risk Reference Set Chart sample Low Risk Green Medium Risk Yellow High Risk Red The upper area labeled Low Risk represents the ra...

Page 457: ...Operator s Guide 437D140 Rev I Reference Data Sets 18 7 Excerpt from Calcified Tissue International...

Page 458: ...Excerpt from the Journal of Bone and Mineral Research Operator s Guide 437D140 Rev I 18 8 Reference Data Sets...

Page 459: ...Operator s Guide 437D140 Rev I Reference Data Sets 18 9...

Page 460: ...land 4 00 1 062 0 126 0 936 0 747 0 558 Y TotalSpine Norland 4 00 1142 135 1007 804 5 602 Y Hip Fem Neck Norland 4 00 0 866 0 113 0 753 0 5835 0 414 Y Troch Norland 4 00 0 697 0 108 0 589 0 427 0 265...

Page 461: ...048 0 772 0 496 Y L2 Norland 4 00 1 291 0 204 1 087 0 781 0 475 Y L3 Norland 4 00 1 309 0 215 1 094 0 7715 0 449 Y L4 Norland 4 00 1 279 0 201 1 078 0 7765 0 475 Y L1 L4 Norland 4 00 1 271 0 191 1 08...

Page 462: ...i Norland 4 00 0 851 0 125 0 848 0 674 0 441 0 726 0 5385 0 351 Y Forearm Distal Norland 798 0 3191 0 04822 0 3191 0 3211 0 2039 0 27088 0 19855 0 12622 Y Caucasian C Female Forearm Proximal Norland 7...

Page 463: ...47 123 1150 1027 903 1024 839 5 655 Y Cauc Hisp CH Female AP Spine L1 Norland 4 00 1 054 0 152 1 041 1 041 0 775 0 902 0 674 0 446 Y L2 Norland 4 00 1 124 0 159 1 100 1 100 0 820 0 965 0 7265 0 488 Y...

Page 464: ...47 1 130 1 113 0 983 0 7055 0 428 Y TotalSpine Norland 4 00 1257 199 1234 1216 1198 1058 759 5 461 Y Hip Fem Neck Norland 4 00 1 107 0 126 1 109 0 939 0 769 0 981 0 792 0 603 Y Troch Norland 4 00 0 92...

Page 465: ...0 675 0 4875 0 300 Y TotalHip Norland 4 00 1021 109 912 748 5 585 Y Norland Reference Data Set Values continued This reference set has Age Matched values for ages 20 50 and 90 NHANES III Reference Dat...

Page 466: ...Operator s Guide 437D140 Rev I This page intentionally left blank...

Page 467: ...search Small Subject options 3 36 Small Subject 9 16 Whole Body options 3 34 Whole Body scan 5 15 Analyzing Saved Scan Data 11 59 Angulated cursors modifying 11 67 selection 3 31 AP Leg Rest Block see...

Page 468: ...ioning 2 7 leg rest 2 7 leg separator 2 7 BMD QA Report 2 31 4 14 Body Composition Report 2 28 6 11 Body fat Charts 6 5 Bone Exam Report AP Spine scan 7 26 details 2 17 Hip scan 8 31 Lateral Spine sca...

Page 469: ...edure 8 7 Lateral Spine Scan 10 7 Research Scan 9 7 Small Subject Scan 9 7 Whole Body Scan 5 6 Classification specifications 17 4 Cleaning Positioning Aids 15 2 QC phantom 15 2 scanner exterior 15 2 t...

Page 470: ...sors adding Special Region 11 38 Customer Info tab 3 39 Customer service contact information 1 3 CV see C V 7 2 D Daily System Calibrations see Calibration 4 6 Damage check Calibration Standard for 4...

Page 471: ...8 Modality Worklist 13 5 patient files 13 3 Preferences dialog box 13 4 Preferences Advanced 13 7 Push button 13 15 Query results 13 11 Refresh file listing 13 17 Requirements 13 2 Services menu Patie...

Page 472: ...Commands 3 16 File Tools command 3 47 3 47 Find Origin command 3 48 FolderMAIL address book 11 12 import to a Database 11 13 not active 16 9 overview 11 9 sending 11 9 Force Mark Points On Axis 11 66...

Page 473: ...parameters 3 24 scan specifications 8 2 scanning procedure 8 7 8 22 scanning techniques additional 11 69 Scout scan 8 18 unsatisfactory scout scan 11 70 Hip Fracture Risk Ten Year 12 1 Hip Sling part...

Page 474: ...17 19 17 20 17 21 warning 17 20 17 21 Laser control button 2 6 indicator 2 6 positioning aid 2 6 precautions 2 6 specifications 17 2 Lateral analysis defaults 3 35 Lateral Limb Support block 10 10 10...

Page 475: ...11 Menopause Year field 4 26 Menu commands see Commands 3 15 Messages Out of Range Precision or Accuracy 4 19 Metallic objects scanning 1 2 Microphone installation 3 6 when used 11 5 where used 11 2 M...

Page 476: ...scan 7 10 Hip scan 8 10 8 15 Lateral Spine scan 10 10 10 12 Research scan 9 10 Small Subject scan 9 10 Whole Body scan 5 9 Patient Worklist 13 10 Patient s Report see Patient Letter 2 22 PDF export a...

Page 477: ...ositioning 4 7 15 6 check for damage 4 6 cleaning 15 2 damaged 4 6 description 2 6 multiple scans 15 5 picture 4 6 statistics messages 4 19 QC Results Statistics Messages 4 19 QC Scan command 3 46 Qua...

Page 478: ...I Data Set Values 18 15 Norland Data Set Values 18 10 Norland Fracture Risk 18 6 Osteoporosis 18 3 Other Bone Active Diseases and Conditions 18 3 overview 11 26 print a 11 34 selection 11 35 send a 11...

Page 479: ...ults 3 28 Small Subject 9 2 Results AP Spine scan 7 21 Hip Scan 8 26 Lateral Spine scan 10 24 patient analysis see Bone Exam Report 2 17 Research Scan 9 18 Small Subject Scan 9 18 Soft Tissue Comp Who...

Page 480: ...7 disabled 4 6 Forearm options 3 25 Forearm parameters 3 25 Hip parameters 3 24 Hip procedure 8 7 Hip scan options 3 24 implants 1 2 Lateral Spine options 3 27 3 27 Lateral Spine parameters 3 27 3 27...

Page 481: ...Software installation 3 2 logging off 4 34 logging on first time 3 11 4 4 overview 3 12 3 51 uninstalling 3 8 windows based 2 6 Sound Note see Voice Note 11 2 Special Regions adding 11 39 analysis ove...

Page 482: ...otic Risk 12 1 Printing a Report 12 8 Questionnaire 12 3 Risk Factors 12 3 Ten Year Fracture Risk Report 2 26 12 9 Tissue Composition Standards 6 2 Tools menu commands 3 47 Audio Dictation 3 47 DICOM...

Page 483: ...ts window 4 19 symbols 1 6 WEEE label 17 17 Weight field 4 26 WHO Criteria fracture risk assessment 2 11 Whole Body Analysis 5 15 analysis defaults 3 34 Analyzing saved scan data 11 59 Bone Exam Repor...

Page 484: ...Operator s Guide 437D140 Rev I This page intentionally left blank...

Page 485: ...ON the laser Move the scanner arm until the laser dot is positioned 1 cm below the xiphoid process and then press the button on the Scanner Arm Touch Pad MARKING THE END POINT Move the scanner arm so...

Page 486: ...pt in the case of a previous fracture or prosthetic device On the leg that will not be scanned gently pull the Velcro strap to the next reference number to rotate the hip Repeat the process on the leg...

Page 487: ...the patient s head and press the button on the Scanner Arm Touch Pad MARKING THE END POINT Move the scanner arm over the patients abdomen Turn ON the laser Pos ition the laser dot at a point on the a...

Page 488: ...ottom of the window You may click the Save All button to save all worklist results to your patient database or highlight one or more entries and click Save Exporting and Pushing DICOM Reports After co...

Page 489: ...al ibration Standard Plexiglas surface identified by the inscribed letter B and press the MARK button Place the QC Phantom in the marked location next to the Calibration Standard parallel with the bac...

Page 490: ...apply to any other versions of Windows To configure the backup refer to Configuring Backup for Win dows 10 on page 3 5 TO BEGIN THE SYSTEM BACK UP MANUALLY Exit the Illuminatus software to the Windows...

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