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accuDEXA User Guide - JD Honigberg International

1. 15 16 accuDEXA User Guide The Confirm Multiple Copies Screen appears A Press YES and proceed to the next step OR B Press NO to print only one copy of the report After the copy is printed the Welcome Screen re appears The Enter Multiple Copies Screen appears A Enter the number of copies to be printed from 1 to 9 B Press OK The Printing Copies Screen appears After the last copy is printed the Welcome Screen re appears Print multiple copies Figure 25 Multiple Copies Confirmation Screen Enter number of copies 1 9 BACK 1 2 3 OK 4 5 6 0 7 8 9 CLEAR Figure 26 Multiple Copies Screen Printing report Please Wait Printing Copy 1 Figure 27 Printing Copies Screen B7101220 Rev E Bone densitometry report Several examples of bone densitometry reports appear on the following pages All of the reports share some common features including general report information report date and time software version and device serial number patient information Patient ID Gender Age and Ethnicity and BMD test information X ray image area and BMC and BMD results There are also some report differences as described below In Figure 28 a patient s BMD results were compared with an available normative database The t score was calculated from the BMD results of the patient and a database population matching the patient s gender and ethni
2. An epoxy and an aluminum finger wedge of known density are aligned in the field of view FOV of the sensor The known density of the wedge is used in bone density estimation allowing for a relationship to be established between X ray attenuation and density which is applied to every pixel of the X ray sensor in the FOV Furthermore the inclusion of the wedge within the FOV allows a calibration test to be performed during each exam Duty cycle cooling The X ray tube used in the accuDEXA has the following duty cycle DUTY CYCLE BETWEEN EXPOSURES MINUTES DI E o i l Q O o 60 120 180 240 300 X RAY EXPOSURE IMPULSES 60 impulses per second The accuDEXA pulses last approximately 0 14 seconds which is equivalent to 8 4 pulses indicated by the x in the above graph The accuDEXA has two X ray exposures High Energy 09 seconds maximum Low Energy 06 seconds maximum 44 B7101220 Rev E accuDEXA User Guide Specifications Mechanical Weight 66 lbs 29 7 kg Size 14x 15 x 14 in 35 56 x 38 1 x 35 56 cm Window Clearance 6 x 4 5 in 15 24 x 11 43 cm Electrical Safety and EMC Standards Compliance IEC 601 1 IEC 601 1 2 IEC 601 1 3 IEC 601 2 7 IEC 601 2 28 IEC 601 2 32 UL2601 1 CAN CSA C22 2 No 601 1 M90 Maximum Line Current And Voltage 127 VAC at 2 5 Amps 115 VAC units 253 VAC at 1 25 Amps 230 VAC units
3. PRINTER PORT PRODUCT LABEL FUSES DISK DRIVE REGULATORY LABEL POWER INLET Figure 2 The accuDEXA Device back view Printer installation 1 Verify that the printer is compatible with accuDEXA Refer to Appendix E on page 64 2 To install a compatible printer perform steps 3 through 6 then perform Changing the printer procedure on page 27 3 Make sure the accuDEXA is off the On Off key switch is in the Off position 4 Attach the printer cable to the accuDEXA parallel port Figure 2 If a power supply was supplied with the printer make that connection also 5 If not already connected plug one end of the power cable to the power inlet and plug the other end into an appropriately grounded outlet 6 Insert the key in the On Off key switch Figure 1 and turn it counter clock wise to the On position The On Off indicator light will illuminate and the Welcome Screen appears accuDEXA User Guide B7101220 Rev E 3 Printer connections The block diagram below details the external connections of the accuDEXA the printer and the printer power supply optional depending on the printer AC line Printer power supply input printer dependent 115 230 a Typical printer ls AC line input 115 230 A C line voltage is factory set for either 115 or 230V Figure 3 Typical Printer Connections Turning on the accuDEXA PLEASE NOTE The accuDEXA must be kept in the prescribed temperat
4. Version 1 50 9 20 00 NDB 1 1 Unit 1772 Sensor 2385 Checking ST2385 LO Figure 6 System Check Screen The system will now perform an internal calibration check Sensor Verification Test This requires taking one x ray exposure With nothing in the hand slot OK Figure 7 Sensor Verification Initial Screen 8 B7101220 Rev E accuDEXA User Guide The Sensor Verification Screen appears Sensor Verification Test attempt 1 of 3 Please remove everything from the hand slot and proceed to take an x ray A Press OK OK Figure 8 Sensor Verification Follow up Screen The Exposure Screen appears A Press and hold down the X ray Enable button to take one test exposure Ready to take x ray OR Push and hold down X RAY ENABLE button to activate B Press CANCEL If CANCEL is pressed the system will revert to the CANCEL system check screen in Figure 6 Exposing at 50 kvp 0 25 mA sec Figure 9 Exposure Screen The Release Button Screen appears A Release the X ray enable button Release button B Please wait for a moment while the system continues the test Figure 10 Release Button Screen accuDEXA User Guide B7101220 Rev E 8 When the test is complete the system will pass or fail A brief message reporting the test results is displayed on the touch screen A The system passes and no other actions are needed Click OK OR B The system p
5. Asian Female Hispanic Female Hispanic Female Hispanic Female Hispanic Female Hispanic Female Hispanic Female Hispanic Female Hispanic Female 888988 1 2 1 1 1 2 3 4 5 6 6 7 8 2 3 4 5 6 7 88 6 7 2 35 2 3 4 5 0 7 8 8 8 20 3 3 4 5 63 7 8 RARLGFKFRRRFSBARHGRRRRAGRARHGFRRRGRARSEEAR Figure 53 Patient Log Report 52 B7101220 Rev E accuDEXA User Guide Copying the Patient Log Report into Excel Follow this procedure to copy the Patient Log Report into a spreadsheet program like Microsoft Excel To perform this procedure you will need a floppy disk with a Patient Log Report file on it and a recent version of Microsoft s Excel program on your computer Your version of Windows should also be Windows 95B or higher If you need information on copying log files to floppy disk refer to the previous section 1 accuDEXA User Guide A Insert the floppy disk containing the Patient Log Report into your computer B Start Windows Explorer and browse to the drive letter on your system corresponding to the floppy drive C Do the following e Click once on the log file the Patient Log Report to select it e Press and hold down the Shift key e Click the right mouse button right click D A short menu similar to the one shown appears Select the Open with option The Open With dialog box appears A Scroll down the list of programs and click once on exce
6. Environmental Operating Temperature 40 to 110 F 4 to 43 C Storage Temperature 30 to 150 F 34 to 66 C Humidity 20 to 80 Highest Permissible Temperature Limit 150 F 66 C X ray Head General Maximum Heat Dissipation into Oil 110 Watts Continuous Nominal Anode Input Power 700W Maximum Anode Input Power 700W X ray Source Schick Technologies P N B7119000 Low Energy 50 kVp 0 5 mAs High Energy 70 kVp 0 9 mAs zinc filtered Collimator Schick Technologies P N B7119200 1 165 x 0 915 in 2 9591 x 2 3241 cm lead window non detachable identified by X ray Source Assembly Serial Number marked on X Ray Source Assembly Image Receptor Accessories Attenuation Negligible X ray Source Assembly Compliance See Safety and EMC Standards above X ray Tube Voltage Measured By Victoreen Neromax 8000 Serial Number of X ray Tube Make and Serial Number on X ray Source Assembly Single Load Rating 63 Joules Serial Load Rating 88 Joules Maximum X ray Tube Assembly Heat Content 7000 Joules Target Material Titanium Target Angle 19 Nominal Focal Spot Value 0 8 mm LE C Filtration High Energy Only 0 5 mm Zn equivalent to 4 mm AI approximately Total Filtration Equivalent to 4 5 mm Al approximately High Voltage Generator Model Schick X ray Corp P N 2426 2050X High Voltage G
7. LIastof printers o see OR Pe EPOR oe Se Ga iet te ae ae 64 APPENDIX F unci n iia idw Sedulo Sav ddieduse p cal I UNDA KR nU anaenda raien 65 Calculating Reference BMD teo dee Rr P E E ee eie AE EE 65 EENEG 67 Equipment Labele eeneg nad oO pota aae ema 67 GLOSSARY OF RE 68 INDEX E 69 ii B7101220 Rev E accuDEXA User Guide List of Figures Figure 1 The accuDEXA Device front view 3 Figure 2 The accuDEXA Device back Vie W ooooncoccnonononononcononononnncononanonononnnonnnconoco nero een conocio rn nennen eterne 3 Figure 3 Typical Printer Connections oooocnoccnonnconoconcnononononnnonncnnnonn nono n non nnnnnnn cnn cone cn nennen trennen eene enne enne 4 Figure NAAA REDI er pee rie ie Corea eiecit rh pedes 6 Figure S EE 8 Figure 6 System Check Screen eoe eo ENER Eege 8 Figure 7 Sensor Verification Initial Screen 0 lees cseeeeeeeeeeeeeeeeesceseeeeeesecsecaecsaecsaecsaecaecsaessaecnaeeaeeeas 8 Figure 8 Sensor Verification Follow up Screen sse ener ener ener trenes 9 Figure 9 Exposure Screen iue etie coated tie espe nitet i tte nt HR 9 Figure 10 Release Button Screen 9 Figure 11 Test Results cren cai peo EEN 10 Figure VU Mam Menu Screen od neret eher elder ert iri ig gere i Rete ettet d heit hte 11 Figure 13 Patient ID SCr eni eie eei ERU C ua otn iei i bd teu 11 Figure DEE 12 Figure 15 Gender Screen ics uio iore aba ete beer eemper baeo 12 F
8. The BMD Test Results Screen normative database is available appears The screen shows that a normative database exists for the patient s ethnicity gender and age The results include the BMD BMC t score and z score A Press YES to print the test results and proceed to the next numbered step OR B Press NO to exit the BMD Test Results Screen The Welcome Screen re appears The BMD Test Results Screen normative database is not available appears The screen shows that a normative database does not exist for the patient s ethnicity gender and age The t score and z score have not been calculated A Press YES to print the results and proceed to the next numbered step OR B Press NO to exit the BMD Test Results Screen The Welcome Screen re appears Computing BMD Please Wait Performing analysis Step 7 9 Figure 22 Computing BMD Results Screen 03 29 99 02 28 PM ID 1234567890 Gender Female Age 33 Ethnicity Asian BMC 1 363 y BMD 0 79 g cma2 t score 1 0 z score 1 5 Print YE N 2 reports D Figure 23 BMD Test Results Screen with t and z scores 03 29 99 02 48 PM ID 1234567899 Gender Female Age 55 Ethnicity Other BMC 2 146 g BMD 0 555 g cmn2 t score WA z score WA Print YE N 3 reports z Figure 24 BMD Test Results Screen without t and z scores 16 B7101220 Rev E accuDEXA User Guide 14
9. to the Phantom Test Results screen A or the label on the phantom standard B 05 21 00 02 28 PM C H BMD 0 554 g cm 2 Phantom BMD range 0 520 0 580 Average BMD value n a Average BMD range n a Precision n a OK A Phantom Results Screen B Phantom Standard Figure 55 Reading the Results of the First 10 Phantom Tests Until there are 10 in range results Average BMD value and range are listed as not available n a on the Phantom Results Screen Similarly the graph on the Phantom Test Report cannot be plotted until a Reference BMD is calculated Refer to Figure 56 for an example Reference BMD is calculated when 10 in range Phantom BMD values are available From that point users should refer to the Phantom Test Results screen instead of the label on the phantom standard for test results The Reference BMD is specific to the particular accuDEXA unit and does not change once it is calculated Once the Reference BMD is determined it becomes possible to track the performance of the system By performing a phantom test and printing the Phantom Test Report users have the opportunity to review the historical system performance based on the last 10 phantom tests accuDEXA User Guide B7101220 Rev E 65 accuDEXA QC PHANTOM TEST REPORT Date 08 12 00 10 15 AM Version 1 50 09 20 00 NDB 1 1 Unit 701T Serial 5100 QC Phantom Test Results emo 1 128g Precision Jo Image
10. Osteoporosis 30 40 SO 60 70 80 90 100 Age po f SCHICK TECHNOLOGIES ING Figure 29 Example of Densitometry Report without z score 22 B7101220 Rev E accuDEXA User Guide accuDEXA BONE DENSITOMETRY REPORT Date 09 25 00 11 11 AM Version 1 50 09 20 00 NDB 1 1 Unit 1772 Serial 2395 Image not for diagnosis Gender____ Male Ethnicity Hispanic BMD Test Results 1 348 g 1 709 cm BMD 0 789 g cm z score Calibration status Passed Age matched BMD See Note WEG e tscoe Relatveto YHN See Note Male Caucasian reference curve Note A normative database is not currently installed for this patient s ethnicity or gender The reference curves are based on the Caucasian database for the same gender These results cannot be used for diagnosis Age matched 3 3 SD 131 BMD Relative to 3 5 SD 132 YHN f SCHICK TECHNOLOGIES ING Figure 30 Example of Densitometry Report no database available accuDEXA User Guide B7101220 Rev E 23 Changing the time 1 If the accuDEXA is not on already turn Welcome To the On Off key switch to On The Welcome Screen appears Ey A Touch any part of the Welcome Screen Touch anywhere to begin 2 The Main Menu Screen appears A Press Configuration Main Menu BMD Test Configuration System Check 3 The Configuration Menu Screen appears A Note where the date and time appear on the
11. a physician as one factor in conjunction with other clinical indicators to diagnose osteoporosis and other bone disorders T scores and z scores can only be computed if a normative database of other individuals with the same age gender and ethnicity of the patient is available When the matching reference database is unavailable the patient s BMD can still be used to compare with an initial baseline value Using accuDEXA t scores in your practice Low bone mineral density at the finger has been demonstrated to be as predictive of generalized fracture in the elderly as measurements made at axial sites All bone mineral density measurements should be used in conjunction with other risk factors in determining fracture risk Other clinical measurements such as blood pressure and cholesterol indicate risk of stroke and myocardial infarction Similarly evidence of osteoporosis according to the World Health Organization WHO indicates risk of fracture not certainty Evidence of normal bone mass according to WHO criteria provides no assurance that a patient will not fracture Nevertheless bone mineral density is just as predictive of future fracture as blood pressure measurements are of future risk of stroke A recent consensus article published by the scientific advisory board of the Bone Measurement Institute suggests using an intervention threshold on peripheral instruments of t lt 1 0 According to independent data collected on the accuDEXA
12. again the Main Menu screen will appear BACK System check menu System Test Phantom Test Printer Test Figure 37 System Check Screen Do you want to print a test page Figure 38 Print Test Page Screen 30 B7101220 Rev E accuDEXA User Guide accuDEXA PRINTER TEST PAGE Date 09 25 00 11 11 AM Version 1 50 09 20 00 NDB 1 1 Unit 1772 Serial 2395 e Figure 39 Example of Test Page accuDEXA User Guide B7101220 Rev E 31 Performing a phantom test The phantom test is an additional quality control check of the accuDEXA system It requires a finger phantom Schick Part Number B7123100 and takes about 2 minutes to complete Like any diagnostic tool the accuDEXA may over time require servicing to assure the accuracy of the unit The phantom test is a quick way for users to verify that the accuDEXA is maintaining its highest level of performance Please keep in mind that the phantom test does not affect or replace the other system checks conducted by the accuDEXA Internally both calibration and quality control are performed each time the unit is turned on There are other good reasons for performing the phantom test More frequently medical practitioners are being asked by insurance companies to provide quality control printouts for all their diagnostic devices By performing the phantom test users are automatically prompted to print a QC test report which can be used to satisfy a req
13. between each beep During the beep the X ray Exposure light turns on momentarily Position phantom in hand slot now Please Wait Checking Acquisition Ready to take x ray Push and hold down X RAY ENABLE button to activate accuDEXA User Guide B7101220 Rev E C Release the button when the second X ray screen displays the Release button message D Lower the lever knob and remove the phantom E Wait for an X ray image to appear on the display as shown in step 7 OR F Press CANCEL You can either resume testing by repositioning the phantom or terminate the phantom test entirely If you wish to terminate the phantom test the Welcome Screen re appears PLEASE NOTE If the phantom is removed during the X ray process or was not positioned properly the message No finger detected is displayed The test will be terminated and the Phantom Positioning Screen will re appear The Bone Outline Screen appears A Press ACCEPT and proceed to the next step OR B Press REJECT to repeat the phantom test The Phantom Positioning Screen will appear again Release button Reading reference frames Bone outline ACCEPT REJECT Figure 42 Bone Outline Screen 36 B7101220 Rev E accuDEXA User Guide 10 accuDEXA User Guide The Computing BMD Screen appears This screen appears while the accuDEXA is computing the results for t
14. de 2 Controls and indicators eet Rr doit 3 Isis muita 3 Printer connections eec ele 4 Turning on the accoDEXA iP EELER 4 Turning otf the accuDEXA EE 4 New features in software Version 1 50 soie reete re rU pev E Eee meo det Ure eve oue 3 Software upgrade procedure eee sese eee nnne neenneen rene enne enne enne aese eene enne 5 Conventions used dn textile epe ere Pp eee pe age sap epe eite ESA 3 USING ACCUDEXA WEE 6 THE TOUCH SCREENS eignet Eee vete ER eR CREE Sege Se See E CE CO REB Ae 6 Screen navigation i aco o Rete o RI i ote neci d ete eet e qo p can He ES ries 6 Finger placement oue ea de ithepte 6 Finger placement and Jewelry is c ge UT RR ENTER HERE rr UR ERO D rita 7 What if hand jewelry cannot be removed cece eesecescecseceseeecseceeneecsseceeeecsaeceeeecseceeneecaeeseaeecaeeceaeees 7 Obtaining successful BMD test results 7 Operator checklist 2 2 Hx Eden RU Ut tener dede Te etc eet pte 7 Getting started eee ota ree e e ORC ede EE etr re eerie deer 8 Pertorming a BMD test eie ee Ee b ceste eet aoe Aue ieee 11 Bone densitometry report SEENEN SEENEN he eicere Dee bue Fede deceat den 18 Categories of risk for fract re omnia 20 Other risk faetors tert RERO TORRE ERE TUR GERE Oe PLE rotis 20 Chan Sins the tM seriada iden 24 Changing the daie sc 25 Changing the printet unes veu eH eI eU Hee 27 Printing a test page uere R
15. delete the default printer code from the display Enter the appropriate printer code provided in Appendix E of this User Guide TIP If your particular printer model is not listed try a printer code from the same manufacturer If you receive an error message call Schick Technologies for assistance B Press OK to accept the printer This number is now stored by the system and will be used to configure the printer TIP If you entered the wrong printer number press CLEAR and re enter A Ifthe Insert Printer Driver Screen appears insert Printer Driver Disk 1 into the floppy drive and press OK B The Upgrading Printer Screen appears C Upgrade is complete when the Printer Driver Changed Successfully Screen Figure 36 appears in about one minute Remove the printer driver disk and press OK D When the Configuration Menu Screen appears press BACK E The Main Menu Screen appears Now you can perform BMD tests using the new printer 1 2 3 OK 4 5 6 0 7 8 9 CLEAR Figure 34 Printer Screen Insert accuDEXA printer driver disk 1 in the floppy drive OK Upgrading Printer Please Wait Figure 35 Printer Driver Screens 28 B7101220 Rev E accuDEXA User Guide A If the Insert Printer Driver Screen did not appear you will see the Printer Driver Changed Screen almost instantly When this screen appears the upgrade is complete Printer driver changed successf
16. for the patient s gender and or ethnicity Refer to Appendix A for a list of available normative databases Warning Normative database is not installed for specified gender and or ethnicity No t score or z score possible Another screen typical to the one shown at the right will appear if the patient s age is outside the range in the normative database In this case no z score is possible Figure 17 Database Information Screen A Press OK The Summary Screen appears This screen contains the information entered in the previous screens The user has three options A Press OK to accept the summary screen entries OR B Press REDO to re enter patient Patient information summary information The Ethnicity Screen will re appear Press BACK and OK to ID 218750397 navigate among the previous information Gender Female Age 55 screens and re enter patient information A Ethnicity Caucasian as needed Return to the Summary Screen and press OK to accept new entries OK REDO CANCEL OR C Press CANCEL to terminate the Figure 18 Summary Screen BMD test Previous entries are deleted and the Welcome Screen re appears Information shown in Figure 18 Summary Screen is provided only as an example accuDEXA User Guide B7101220 Rev E 13 10 The Positioning Screen appears Place the patient s hand into the hand slot If needed refer to the Finger Placement picture on
17. message No finger detected is displayed and the Positioning Screen will re appear 11 The accuDEXA produces an X ray image A Press ACCEPT if the X ray image is acceptable refer to examples of acceptable images below and proceed to the next step Bone Outline OR B Press REJECT if the X ray image is unacceptable refer to examples of ACCEPT REJECT unacceptable images below When REJECT is pressed the Positioning Figure 21 Bone Outline Screen Screen re appears Re position the patient s hand and repeat the X ray exposure by completing steps 9 10 Finger positioning guidelines The following images are acceptable because the sensor captured both sides of the middle finger as shown by the arrows Bone SUUS Bone T Bone Outline The following images are unacceptable The image on the left is unacceptable because the sensor did not completely capture both sides of the middle finger as shown by the arrow The image on the right is unacceptable because a ring is within the field of view These images will yield inaccurate results and should be rejected Bone Outline Bone Outline accuDEXA User Guide B7101220 Rev E 15 12 13 The Computing BMD Screen appears This screen appears while the accuDEXA is computing the results for the BMD Test The process takes less than a minute When completed the accuDEXA will automatically advance to the BMD test results screen
18. not for diagnosis Calibration status Passed NOTE QC graph cannot be printed until a reference BMD is available The reference BMD is the result of running the QC phantom test 10 times You do not need to run all 10 tests at one time but you should perform them at your convenience To date you have run the QC phantom test 2 times 7 Figure 56 Example of Phantom Test Report Before Reference BMD is Available 66 B7101220 Rev E accuDEXA User Guide Appendix G Equipment Labels The following labels are located on the front and back panels of the accuDEXA Front Panel Warning Label CAUTION ATTENTION X RAYS RAYONS X WARNING THIS X RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED AVERTISSEMENT CET APPAREILA RAYONS X EST DANGEREUX POUR LE PATIENT ET POUR L OPERATEUR SI LES REGLES DE SECURITE ET LES INSTRUCTIONS D OPERATION NE SONTPAS RESPECTEES x Back Panel Product Label O CES S CHICK ricer suscuapren y ECHNOLOGIES INC COMPLIES WITH DHHS RADIATION 31 00 47 AVENUE LONG ISLAND CITY NY 11101 CAUTION MODEL 7100 FEDERAL LAW RESTRICTS THIS SERIAL NO DEVICE TO SALE BY OR ON THE MANUFACTURED ORDER OF A PHYSICIAN Back Panel Regulatory Label X ray Head S N KA A CE Conforms to UL Std 2601 1 Certified to CAN CSA C22 2 No 601 1 230V Units 230
19. the On Off key switch to On The Welcome Screen appears Ev A Touch any part of the Welcome Screen Touch anywhere to begin 2 The Main Menu Screen appears A Press System Check Main Menu BMD Test Configuration System Check 3 The System Check Menu appears A Press System Test eebe SE System Test Phantom Test Printer Test 4 Please wait as the accuDEXA performs its internal checks Running System Check Please Wait Version 1 50 9 20 00 NDB 1 1 Unit 1772 Sensor 2385 Checking ST2385 LO 40 B7101220 Rev E accuDEXA User Guide Screen accuDEXA User Guide Press OK to return to the Main Menu All system tests passed B7101220 Rev E 4 Maintenance There are no serviceable parts inside the accuDEXA and no scheduled maintenance is required If there are any problems with the accuDEXA please contact Schick Technologies at 888 818 4BMD or 718 937 5765 Fuse replacement instructions Replacement fuses are provided with every accuDEXA device If the accuDEXA does not respond when power is applied On Off indicator does not light and LCD display stays blank one of the fuses may have blown CAUTION Ensure the accuDEXA is turned off and disconnected from its power source before inspecting and replacing fuses Fuses are located on the back of the accuDEXA and can be removed by inserting a flat blade screwdriver into the fuseholder slot pushing forward slightly an
20. the amount of detail cannot be displayed effectively in the small viewable area of the touch screen Looking at the QC Phantom Test Graph it is easy to follow certain trends in Phantom BMD and QC Average BMD results The x axis in the middle of the table Reference BMD provides the guideline for interpreting these results When the system is performing optimally Phantom BMD values shown as s on the graph will fall within Phantom limits and QC Average BMD values shown as s will fall within QC Limits Limits are specified in the configuration file It is important to remember that whether users choose to print the report or not the system displays the results of the current phantom test and will provide if necessary any additional direction When both Phantom BMD and QC Average BMD are within the limits for the system the precision for the unit is considered satisfactory and is reported as OK If precision is listed as Out of Range it means that the BMD result is outside the 0 52 and 0 58 range for acceptable results In this event users will be prompted for additional action 32 B7101220 Rev E accuDEXA User Guide QC Phantom Test Results Always reported when printing the phantom test report QC Phantom Test Results Only printed after the Reference BMD is available QC Phantom Test Graph Reference BMD Available after the first 10 phantom tests Refer to the Glossary for more details Re
21. the wrong date press CLEAR and re enter Enter start date MMDDYY Figure 49 Transfer Date Screens The Transfer Confirmation Screen appears A Press OK to accept the entered dates and to initiate the transfer process Voudsked totransfer tii s OR corresponding to the following dates MMDDYY MMDDYY B Press Retry to re enter the dates The Transfer Date Screens will re appear mm CM cr OR C Press Cancel to return to the Figure 50 Transfer Confirmation Screen Configuration Menu Screen 50 B7101220 Rev E accuDEXA User Guide accuDEXA User Guide The Transfer in Process Screen appears A Wait for the transfer process to finish When the transfer has been completed successfully the following message is generated Data transfer successfully completed OR B Press CANCEL to halt the transfer process The Configuration Menu Screen will re appear A When the transfer has been completed successfully press OK to return the Configuration Menu Screen B If you chose to print the report the Patient Report will begin printing when data transfer is complete C If you chose to copy the Patient Report to floppy disk remove the disk when data transfer is complete D If you wish to use the Patient Report in another application continue with the section Copying the Patient Log Report into Excel on page 53 or Copying the Patient Log Report into Notepad or WordPad on pa
22. 612C 648C 695C 697C 812C 840C 842C 880C 882C 895Cse 930C 932C 935C oO 950C 952C 970Cse 970Cxi 990Cxi 990Cse Yes 3 1 minute a 1220C 1220Cse 1220Cxi 1220C PS 1125C only available in Europe amp Japan 3 LaserJet Series 5 6 1100 4000 Yes 13 30 seconds DeskJet 340 420C 710C 712C 720C 722C Not Compatible x Optra Laser Printers E312 E312L Series Yes 10 30 seconds E ExecJet IIc Yes 11 minute 3 TS Not Compatible With black ink cartridge BC 02 installed When color ink cartridge BC 05 is used print time is 4 minutes Exact time to print BMD reports is not available for these printers i Compatible with accuDEXA software version 1 50 or higher only After printing BMD report printer may execute an extra page feed 64 B7101220 Rev E accuDEXA User Guide Appendix F Calculating Reference BMD The information in this appendix is intended for e Users upgrading their accuDEXA units to software version 1 50 Version 1 50 software provides additional reporting about the accuDEXA system This reporting uses phantom tests to evaluate the system s range of performance how well the system is performing within predefined thresholds To help describe this range a baseline measurement Reference BMD is needed Reference BMD is the result of averaging the first 10 Phantom BMD values that fall within the range of the phantom standard To verify whether the result is within range users can refer either
23. 8 29 31 33 38 44 52 WHO Definition of 72 X X ray Screens 18 39 40 Y YHN Definition of 72 Z z score 5 Definition of 72 70 B7101220 Rev E accuDEXA User Guide
24. Dace 18 B7101220 Rev E accuDEXA User Guide On the sample reference curve shown below the scale of t scores is shown at the left and the scale for age is at the bottom The three curved lines are isometric z scores The top curve represents one standard deviation above the age matched mean BMD The middle curve represents the age matched mean BMD e The bottom curve represents one standard deviation below the age matched mean BMD Isometric t scores are displayed on the y axis e The t scores can be positive or negative and correspond to standard deviation increases or decreases in BMD as compared to a young healthy normal YHN individual The range of ages for z scores is displayed on the x axis e The t score and z score for the scanned patient can be seen graphically on the curve and is represented by a small square box Ml In this example the patient has a lower than mean BMD compared to a young healthy normal t score and age matched z score database 3 High BMD 1 Normal L 8 l Osteopenia 3 E Osteoporosis 5 Age accuDEXA User Guide B7101220 Rev E 19 Categories of risk for fracture Bone mineral estimates can be used to provide an index of fracture risk Individuals who fall below the range of young healthy normal individuals are at a greater risk for fracture The World Health Organization WHO has established four general diagnostic categories that define categories
25. EID erp EE B op choad M eH ap ER ess op RE DH TEE e heb DER RR rns 29 Performing a phantom teste s uec Gg uo GE RU ee Geant ucts ERO eh eiim Eee See 32 Understanding phantom test results 32 Performing a system test saepe he Ree Rh ete i iere EE pepe es 40 SERVICE aiii A 42 Maintenance nr a A nin 42 Fuse replacement instructions secen a enne nennen enne enne ne nene en nnne tenet nest tenen net en tentent enne 42 Cleaning Str Ct Onis eeh EE DEE EE GEREENT 42 SystemcheckKS dees eebe steht ta Dore T efte og nomen 42 accuDEXA User Guide B7101220 Rev E i Static eleettietw T 43 REFERENCE INFORMATION cisjassiccctaicsnccetinascdetcninadadceinstiencsenisaeaecnsennsennawanaees 44 Technical description ici aio PH Peg 44 Duty Cycle COMO EEE OEA E EE E E E eere rtl e e da TE EE 44 Specifications EE 45 Electrical summary ci aaa 46 APPENDIX Acuna 47 Normative data bases ddr ende ice ee eA EG Hee o pre e dele deese re depone 47 APPENDIX B T M 48 Printing and copying the Patient Log Report ocooccnoccnoccnonconnnonnnannnononanonnoconoconocn nooo non nono nooo een rennen 48 Copying the Patient Log Report into Bvcel nennen eene rennen tren 53 Copying the Patient Log Report into Notepad or WordPad AAA 56 APPENDIX C cours 59 Error messages sdb ona en bete 59 eier 62 APPENDIX D 63 Troubleshooting the Canon printer eene enn enne trennen nete ee tenete enne ene 63 APPENDIX O AO 64
26. For additional troubleshooting information refer to the Canon printer manual Users with printers other than the Canon BJC 250 should refer to their product manuals for assistance Problem Solution If printing speed is too slow The printer comes supplied with a Color BJ Cartridge BC 05 Replacing this cartridge with a less expensive Black BJ Cartridge BC 02 will cut printing time in half If the print head moves but nothing prints Try printing a test page from the printer See Canon s User Manual for instructions on printing a test page using the operator panel If you are still unable to print perform at least two thorough cleanings of the print head as described in the Printer Manual If the printing problem persists replace the printer cartridge If the paper will not feed or if the printout is stuck in the printer If the paper will not feed into the printer please ensure the paper was placed properly in the paper tray Remove the paper from the tray and make sure the edges of the paper rest against the back and right sides of the sheet feeder If the power light does not stop blinking Remove and then reinsert the printer ink cartridge If a printed report is scrambled and cannot be read clearly or at all Make sure you are using the correct code number for your printer Follow the steps in Changing the printer to verify that your printer is using the correct code If this does not co
27. S aan 28 Figure 36 Printer Driver Changed Screen eee sees eene nennen EE EESE ene 29 Figure 37 System Check creci iii 30 Figure 38 Print Test Page creia alados 30 Figure 39 Example of Test Page iecore tee pee pee eee Reps 31 Figure 44 Details of Phantom Test Report 33 Fig re 40 Phantom Placement oot atril 34 Figure 41 Bone Outline Screen AA cnebcesondvenevasuuacuscoaces eor hte eg ebd Ee steeveauvbenscb ents 36 Figure 42 Computing BMD Results Screen nennen nennen trennen nennen 37 Figure 43 Phantom Test Results Screen nennen nnne nennen entente ene 37 Figure 45 Example of Phantom Test Reporte sess nren nennen nere ens 39 Figure 46 Patient Log Screen nee ede eet tie e Ie Ene Ehe de BUR EE tes 49 Figure 47 Print Data Serena tuni 49 Figure 48 File Data Screen ette inen EENS re terit 49 Figure 49 Transter Date SCreens eed e e e ebd erc rede 50 Figure 50 Transfer Confirmation Screen 50 Figure 51 Transfer in Process Sereen RA E E EER RT 51 Figure 52 Transfer Complete Screen oerte ee 51 Fipure 53 Patient LOS Report edad id ou Ud tu e ett tere i AE beet 52 accuDEXA User Guide B7101220 Rev E iii Figure 54 Error Message Screen AAA ON 59 Figure 55 Reading the Results of the First 10 Phantom Tests essere 65 Figure 56 Example of Phantom Test Report Before Reference BMD is Avalable 66 iv B7101220 Rev E accuDEXA User Guide The contents of this manual and the bundled accuDEXA software ar
28. VAC 50 60 Hz 1 25A Fuse 1 6 A 250V T 115V Units 115VAC 50 60 Hz 2 5A Fuse 2 5 A 250V SB CAUTION For continued protection against risk of fire replace only with same type of fuse 9801284 Made in USA accuDEXA User Guide B7101220 Rev E 67 Glossary of Terms Area Estimated projected image area measured in cm BMC Estimated bone mineral content of the imaged portion of the finger measured in grams BMD Estimated bone mineral density of the imaged portion of the finger measured in mass per projected area Non dominant Hand All accuDEXA exams are performed on the non dominant hand If a patient is right handed they should place their left hand into the hand slot If the patient is left handed they should place their right hand into the hand slot Phantom BMD The BMD of the accuDEXA phantom P N B7123100 When phantom BMD is reported out of range there may be a problem with system performance Users are prompted to repeat the phantom test to verify results and if necessary take additional actions QC Quality Control Average BMD A measure used in accuDEXA software to help verify system performance QC Average BMD also called Average BMD is calculated from results of the last 10 phantom tests Reference BMD A measure used in accuDEXA software to help verify system performance Reference BMD is calculated from results of the first 10 phantom tests To be included as one of the first 10 te
29. accuDEXAS User Guide LONE OAK MEDICAL TECHNOLOGIES Export Department J D Honigberg International Inc 85 Revere Drive Suite D Northbrook IL 60062 U S A Tel 847 412 0200 e Fax 847 412 0034 Email medical jdhintl com www jdhmedical com Copyright 2001 by Lone Oak Medical Technologies All Rights Reserved Many of the designations used by manufacturers and sellers to distinguish their products are claimed as trademarks Where those designations appear in this document and Schick Technologies Inc was aware of a trademark claim the designations have been printed in caps or initial caps Part Number B7101220 Rev E January 5 2001 LU Printed in the United States of America This User Guide was originally drafted in English F GENERAL DEPTS QA DOCUMENT B7101220RevE doc PHEPAGCE asa EE A The accuUDEXA EE A Indications for DEET A KE EE A SE EE A Symbols and markings EE B Registering your accuDEX A esie nter exea ee epe Ene e beer pene Ene cnn idoneidad E one a C ACCUDEXA OVERVIEW AND SETUP eeeeeeeeeeeeeee enne nnn 1 OWVET VIEW E ates 1 THE t scofe and KEE 1 Using accuDEXA t scores in your practice trennen nennen nennen nein enne enneenne es 1 Monitoring Changes in Bone Mineral Density eese nennen nre 2 Indications REDE 2 VE ee e EEN 2 Known adverse r actions rnnt repe ere reveren eee A eere Ep dE EENS
30. age number if applicable and call us at 888 818 4BMD for assistance Error Can be May be Cannot be Error Message Message corrected corrected corrected Number by user by user by user Data EE Errors Patient ID cannot be greater than 10 digits Please re enter No patient ID entered x Age is out of range Please enter a number between 1 and 120 Patient information is incomplete M Invalid time format must be HHMM 24 hour clock None Too many digits in time maximum 4 Lm MMDDYY sage m BH ET E O ere Invalid poner E lt pimermntes None JB t1 O a not ready Please push on line button Try 122 Dx El accuDEXA User Guide B7101220 Rev E 59 Error Can be May be Cannot be Error Message Message corrected corrected corrected Number by user by user by user 146 163 16 167 ve Could not print Cannot change printer driver Floppy disk is wrong or not ready Could not change printer driver Printing job cancelled due to repeated printer errors Data Transfer Errors Floppy drive error Disk is not ready 154 154 Floppy drive error Disk is full or damaged Floppy drive error Printer driver s disk lt disk None number is not ready Disk space is available for storing only number 159 of more patients End date cannot precede the start date Error Cannot find file specified Data Retrieval Errors Could not acquire image from sensor Cannot read data in sensor ca
31. arnings A Age Screen 16 B BMC Definition of 72 BMD Definition of 72 Obtaining Successful Test Results 11 Operator Checklist 11 BMD Test Sample Screen 20 Steps to Perform 15 Bone Outline Screen 19 Bone Outline Screens 40 C Cleaning Instructions 46 Computing BMD Results Screen 20 41 Configuration Menu Screen 28 30 31 52 Contraindications 6 Controls 7 Cooling Cycle 48 D Database Information Screen 17 Date Additional Details 30 Changing 29 Date Screen 30 Densitometry Report Description 22 Example of 26 27 E Error Messages 63 Ethnicity Screen 16 Exposure Screen 13 F File Data Screen 53 Finger Placement 10 Finger Position Acceptable 19 Guidelines 19 Jewelry and 11 Unacceptable 19 Fracture Risk 24 Other Factors 24 Fuse Replacement Instructions 46 G Gender Screen 16 Getting Started 12 Glossary 72 Indications 6 accuDEXA User Guide B7101220 Rev E Main Menu Screen 15 28 30 31 33 38 44 52 35 Maintenance 46 Monitoring 6 Multiple Copies Confirmation Screen 21 Multiple Copies Screen 21 N Normative Databases 51 Notice Messages 66 O Overview and Setup 5 P Patient ID Screen 15 Patient Log Report 56 Copying and Printing 52 Steps to Copy into Excel 57 Steps to Copy into Notepad or WordPad 60 Patient Log Selection Screen 53 Phantom Example of Report 43 Performing Test 36 Placement 38 Positi
32. ars A Scroll down the list of categories and click once on Text to select it B Click OK A The Excel workbook window is displayed again B Take a moment to look over the data If some of the data had a very long string of numbers or letters you may want to PEPE oa Gi n E es Fe a Pm ae B m ES adjust the width of that column as es es ER D i ita ied mi Ae follows SES E 19 Im D Me ra nes e 8 nm KT LT iMi Ea Hp e Click in the column heading the ee ER im im bell k Pag oo sd Es shaded area ES vm Ew ed im m enr Kee ES mm am a hiss A q e Drag the boundary on the right A Es BE K cim di ua j aji side of the column heading to a larger width A Click on the File menu and then on Save As B When the dialog box opens name the file and select Microsoft Excel Workbook from the Save as type drop down box When saving the file make sure you save it to your hard drive C Click Save Your data has now been saved as an Excel spreadsheet accuDEXA User Guide B7101220 Rev E 55 Copying the Patient Log Report into Notepad or WordPad Follow this procedure to copy the Patient Log Report into a text editor program like Notepad or WordPad To perform this procedure you will need a floppy disk with a Patient Log Report file on it and a recent version of the Notepad or WordPad program on your computer If you need information on copying log
33. asses but we recommend that users verify system performance by running the phantom test A successful phantom test provides the best guarantee of system accuracy Click OK OR C The system fails An error message will appear on the screen Make sure everything is removed from the hand slot You will not be able to perform BMD tests Contact us at 888 818 4BMD for further assistance Click OK Sensor verification test passed Remember Please run the phantom test periodically to verify system performance Sensor verification test passed Important Please run the phantom test immediately to verify system performance Error xxx Sensor verification test failed System malfunction Call Schick Technologies Technical Support Figure 11 Test Results Screen The Welcome Screen re appears A Touch any part of the Welcome Screen to start using the system Welcome To Ubu Touch anywhere to begin 10 B7101220 Rev E accuDEXA User Guide Performing a BMD test Follow this procedure to generate a Bone Densitometry Report Users are encouraged to print BMD reports when prompted by the program particularly to retain the X ray image and graph portion of the report 1 If the accuDEXA is not on already turn Welcome To the On Off key switch to On The Welcome Screen appears EY A Touch any part of the Welcome Screen Touch anywhere
34. ates several internal checks that are similar to those performed automatically on startup Some checks performed only during equipment turn on are not repeated by the System Test Also available from the System Check Menu are the printer and phantom tests USER INITIATED CHECKS e System Test e Printer Test e Phantom Test During BMD tests the accuDEXA verifies X ray exposures as they are taken This verification calculates the difference between high and low energy exposure to ensure that only X rays taken at the correct energy and exposure times are accepted Static electricity Static electricity may cause the accuDEXA touch screen to go blank If this occurs the accuDEXA must be reset to resume normal operation To do so turn the accuDEXA off by turning the key in a clockwise direction wait ten 10 seconds and turn the accuDEXA back on accuDEXA User Guide B7101220 Rev E 43 Reference Information Technical description The accuDEXA estimates bone mineral content BMC g and bone mineral density BMD g cm in a region of the middle phalanx of the third finger of the non dominant hand using dual energy X ray absorptiometry DEXA The technology used in the accuDEXA compensates for the density of soft tissue by acquiring information at two distinct energy levels The accuDEXA emits a low energy X ray pulse at 50 kVp and a high energy X ray pulse at 70 kVp At 70 kVp a zinc plate is used to filter out the low energy X rays
35. city The z score was generated using those same parameters gender and ethnicity and the patient s age In Figure 29 a patient s BMD results were also compared with an available normative database In this report however the z score could not be calculated because the patient s age 95 was out of range and could not be matched with an equivalent age in the database In Figure 30 a patient s BMD results were generated but could not be compared to a database that matched the patient s ethnicity and gender Instead the accuDEXA report will graph the results using reference curves based on the Caucasian database for the same gender These results cannot be used for diagnosis The t score and z score are omitted from the report also Refer to Appendix A for a list of available databases Calculating t scores z scores and fracture risk The following formulas are used in the accuDEXA software to calculate the t score z score and to provide as a percentage where those scores lie in relation to the mean BMD The analysis is calculated automatically based on t score and reported as Normal Osteopenia or Osteoporosis SAMPLE RESULTS 85 O Relative to YHN 92 O Age matched BMD Based on WHO guidelines ITEM FORMULA BMDpatient BMDyun Standard Deviation BMDpatient BMDaAgE Standard Deviation BMD patient x 100 Percentage of YHN BMD BMDyun BMDpatient x 100 Percentage of Age matched BMD BM
36. d turning it counterclockwise Remove the fuse and examine it If the fuse has blown replace it and reinsert the fuseholder by pushing it forward slightly with the screwdriver then turning it clockwise to secure it Cleaning instructions Before cleaning any part of the accuDEXA turn off power and disconnect the power cord Keep the fan area clean and unobstructed and vacuum it from the outside as needed To clean the exterior and hand plate of the accuDEXA moisten a damp lint free cloth with a minimal amount of rubbing alcohol Wipe the external surfaces but avoid allowing any fluid to seep into the accuDEXA CAUTION Never pour or spray any liquid cleansers into the accuDEXA System checks The accuDEXA performs an automatic check of its ability to operate whenever it is turned on Components verified by this check include AUTOMATIC CHECKS e Software executable and system files e Sensor and interface e Mechanical fixture If the device fails the system check an error message will appear on the screen display listing the cause of the problem For example if normal operating temperature limits are exceeded the system will report Error System temperature too hot 70 85 F 21 29 C only or Error System temperature too cold 70 85 F 21 29 C only as appropriate 42 B7101220 Rev E accuDEXA User Guide Users can choose to run a test of the accuDEXA system at any time Pressing System Test at the System Check Menu initi
37. e Printer Patient Log 4 The Date Screen appears A Enter the six digit date 2 digits each for the month day and year PLEASE NOTE The user must enter two digits each for the month day and Enter date MVDDYY BACK year If an entry has only one digit 0 IT 9 a zero must be added in front of it 00 09 1 2 3 OK Below are some examples 4 5 6 0 Ifthe dateis Enter To Display May 3 1998 050398 05 03 98 October 10 1998 101098 10 10 98 i 25 En B Press OK The Configuration Menu Screen will re appear with the x Ia Date Danan revised date TIP If you entered the wrong date press CLEAR and re enter 26 B7101220 Rev E accuDEXA User Guide Changing the printer PLEASE NOTE Users performing this procedure should first refer to the printer code that applies to their printer This code number can be found in Appendix E 1 If the accuDEXA is not on already turn Welcome To the On Off key switch to On The Welcome Screen appears EY A Touch any part of the Welcome Screen Touch anywhere to begin 2 The Main Menu Screen appears A Press Configuration Main Menu BMD Test Configuration System Check 3 The Configuration Menu Screen appears Configuration Menu BACK Current time date A Press Change Printer 05 11 00 11 47 AM Change Time Change Date Change Printer Patient Log accuDEXA User Guide B7101220 Rev E The Printer Screen appears with the default printer code displayed A Press CLEAR to
38. e both copyrighted by Schick Technologies Inc Any reproduction in whole or in part is strictly prohibited accuDEXA is a trademark of Lone Oak Medical Technolgies All third party products and software mentioned within this manual are registered and copyrighted with their respective companies The accuDEXA device The accuDEXA device from Lone Oak Medical Technologies is a bone densitometer that estimates bone mineral density BMD of the middle finger of the non dominant hand It is a self contained table top unit employing dual energy X ray absorptiometry DEXA technology After the finger is scanned results are generated in less than one minute This accuDEXA User Guide contains operation and maintenance information procedures and guidelines for testing interpretation of test results and technical specifications on the accuDEXA device Indications for use The accuDEXA is a dual energy X ray device indicated for use in estimating the bone density BMD of the middle finger of the non dominant hand This BMD value is a relative indicator of bone density elsewhere in the body The accuDEXA s BMD estimates can be used as an aid to the physician in determining fracture risk Warnings e This X ray unit may be dangerous to the patient and operator unless safe operating instructions are observed e The need or appropriateness for BMD measurements of phalanges in the management of renal osteodystrophy has not yet been establis
39. enerator Input Power 197V 22KHz 3 75A at 7OKVp accuDEXA User Guide B7101220 Rev E General Receptor Size 2 x 1 75 in 5 08 x 4 445 cm Reference Axis to Receptor Angle 90 Source To Finger Distance 10 in 25 4 cm Focal Spot to Target Distance 10 4 in 26 42 cm Focal Spot to Skin Distance 9 75 0 2 in 24 77 0 5 cm BMD Precision within 1 X ray Leakage 0 8 mR per hour at 1 meter distance Effective X ray Dose 3E 04 uSv per scan Scatter Radiation 6 1 mR per hour at 1 meter distance Calibration Automatic no user intervention required Scan Time Less than 1 minute Printer See Appendix E for a list of compatible printers The X ray Source Assembly can handle 70K Vp at 2mA continuous Electrical summary Input electrical ratings Equipment type Protective earth Restricted service statement 115 VAC systems 115 VAC 2 5 A 50 60 Hz 230 VAC systems 230 VAC 1 25 A 50 60 Hz Type B equipment A on back panel Protective Earth adjacent to the protective earth conductor inside the system 115 VAC Systems 2 5 Amps 3AG SLO BLO 230 VAC Systems 1 6 Amps 5 x 20 mm T Unless otherwise specified this unit should be serviced only by the manufacturer It contains no user serviceable parts B7101220 Rev E accuDEXA User Guide Appendix A Normative databases Listed below are the current normative database
40. ent 3 Slowly release the handle knob This will lower two levers onto the patient s middle finger one lever will rest near the tip of the finger and the other will rest near the base These levers will gently secure the finger in place during the BMD test 6 B7101220 Rev E accuDEXA User Guide Finger placement and jewelry Since proper finger placement is essential for an accurate and precise BMD test all hand and wrist jewelry should be removed Removing jewelry may improve finger positioning increase patient comfort and help the patient to remain still during the procedure Incorrect positioning or finger movement during testing may lead to inaccurate test results What if hand jewelry cannot be removed If jewelry cannot be removed extra care must be taken to ensure correct positioning For example a ring could prevent a patient from resting their finger against the finger guide As long as the finger placement approximates the description on page 6 and the X ray image contains no part of a ring or jewelry the exam is valid Obtaining successful BMD test results For best results the operator must follow several simple guidelines e The patient s hand must be positioned palm down and held completely motionless throughout the exam e During an exam the accuDEXA should rest on a table roughly 30 inches from the floor Patients should be in a comfortable position during the BMD Test The patient s seat should be stat
41. ference BMD Phantom Test Number The number and the results of the last 10 phantom tests Phantom test number Figure 40 Details of Phantom Test Report accuDEXA User Guide B7101220 Rev E 33 If the accuDEXA is not on already turn the On Off key switch to On The Welcome Screen appears A Touch any part of the Welcome Screen The Main Menu Screen appears A Press System Check The System Check Menu appears A Press Phantom Test The Phantom Positioning Screen appears Place the finger phantom Schick Part Number B7123100 into the hand slot Refer to the figure shown Welcome To aCCUDEAA Touch anywhere to begin Main Menu BMD Test Confiquration Svstem Check System check menu BACK Phantom Test System Test Printer Test Figure 41 Phantom Placement 34 B7101220 Rev E accuDEXA User Guide A Press OK and proceed to next step OR B Press CANCEL to terminate the phantom test The Welcome Screen will appear Please wait for a moment while the accuDEXA prepares to take an X ray The Ready to take X ray message appears Wait for the X ray Enable light to turn on Perform steps A through E to take the X ray or perform step F to reposition the phantom or to terminate the phantom test A Press and hold down the X ray Enable button B Listen for two beeps Each beep represents an X ray exposure and there is approximately a 5 second pause
42. files to floppy disk refer to the section Printing and copying the Patient Log Report on page 48 A Insert the floppy disk containing the Patient Log Report into your computer B Start Windows Explorer and browse to the drive letter on your system corresponding to the floppy drive C Do the following e Click once on the log file the Patient Log Report to select it e Press and hold down the Shift key e Click the right mouse button right click D A short menu similar to the one shown appears Select the Open with option The Open With dialog box appears A Scroll down the list of programs and click once on WORDPAD to select it B For now make sure the checkbox for Always use this program to open this type of file is clear You can check this box at a later time if you want to always start Excel when opening a log file C Click OK al Open Vh El ES peda am you wan Lo us Lo open De He IL ret progra poa eae be not rs ee et eh Other z Aen ust thit pigan Lo opes this ge of fike Cool gp B7101220 Rev E accuDEXA User Guide 3 The Patient Log Report appears in the WordPad window BDOGRE L Fee keg laps DACLICIDEG coed FH Dis WiTBET Pals Tis LEE abra is ki E E t JE b e G mn mm Gel A At this point a few formatting steps are needed to improve the appearance of the table when printed B Click on the Fi
43. for low bone density Normal A value for bone mineral density BMD or bone mineral content BMC within 1 standard deviation SD of the young adult reference mean Low Bone Mass osteopenia A value for BMD or BMC more than 1 SD below the young adult mean but less than 2 5 SD Osteoporosis A value for BMD or BMC of 2 5 SD or more below the young adult mean Severe Osteoporosis A value for BMD or BMC more than 2 5 SD below the young adult mean in the presence of one or more fragility fractures The accuDEXA automatically calculates a patient s risk based on the t score and reports the results as Normal Osteopenia or Osteoporosis The accuDEXA cannot make an analysis of Severe Osteoporosis since this analysis is dependent upon the presence of one or more fragility fractures Other risk factors While low BMD is an important factor in determining a patient s risk for fracture there are several other factors that also contribute to risk Patients with a combination of several risk factors are at an increased risk of fracture The following is a summary of risk factors compiled by the National Osteoporosis Foundation Being female A small thin frame Advanced age A family history of osteoporosis Early menopause Abnormal absence of menstrual periods amenorrhea Anorexia nervosa or bulimia A diet low in calcium Use of certain medications steroids anticonvulsants excessive thyroid hormones certa
44. g Report Press File if you want to save it on a diskette A Press Print to proceed to the next screen OR Print File B Press File to proceed to the next screen Figure 46 Patient Log Screen If you are printing the Patient Log report the Print Data Screen appears You will see a brief message reminding you to turn Ensure printer is ON on your printer and enter the start and end dates of the files you want to transfer inaf t MMDDYY If you are copying the Patient Log Report nue to file the File Data Screen appears m ES You will see a brief message prompting you to insert a formatted PC diskette into the accuDEXA floppy drive A Press OK to proceed to the next Figure 47 Print Data Screen screen and to enter the start and end date information OR Insert a diskette into the floppy drive B Press Cancel to return to the and enter the start and end dates Configuration Menu Screen of the files you want to transfer in a format MMDDYY OK Cancel Figure 48 File Data Screen accuDEXA User Guide B7101220 Rev E The Transfer Date Screens appear A Enter the six digit date two digits each for the month day and year for the start and end dates TIP If you need the results for one day only for example August 15 1998 the start date 08 15 98 and end date 08 15 98 would be the same B Press OK to accept the start and end dates TIP If you entered
45. ge 56 Transferring files corresponding to the following dates MMDDYY MMDDYY File to transfer Filename CANCEL Figure 51 Transfer in Process Screen Data transfer successfully completed OK Figure 52 Transfer Complete Screen B7101220 Rev E 51 accuDEXA PATIENT LOG REPORT Date 01 21 00 2 28 PM Unit 701T Date Age Ethnicity Gender T score Z score 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 2 25 00 Asian Female 0 894 3 57 Hispanic Female 1 022 3 96 Asian Female 0 72 3 446 Asian Female 0 718 2 854 Asian Female 0 757 0 385 Asian Female 0 745 0 323 Asian Female 0 664 0 254 Asian Female 0 618 0 355 Asian Female 0 76 0 767 Asian Female 0 634 1 214 Asian Female 0 69 1 254 Asian Female 0 701 2 068 Asian Female 0 686 2 831 Hispanic Female 0 953 0 81 Hispanic Female i 1 078 0 784 Hispanic Female 0 803 0 64 Hispanic Female F 0 963 1 085 Hispanic Female E Hispanic Female 1 034 Hispanic Female Asian Female F 0 804 Asian Female Asian Female Asian Female Asian Female Asian Female Asian Female Asian Female Asian Female Asian Female Asian Female Asian Female
46. he BMD Test The process takes less than a minute When completed the accuDEXA will automatically advance to the phantom test results screen Computing BMD Please Wait Performing analysis Step 7 9 Figure 43 Computing BMD Results Screen The Phantom Test Results Screen shown at right appears A Press OK PLEASE NOTE If Average BMD value and range are listed as Not Available n a refer to Appendix F Calculating Reference BMD on page 65 05 21 00 02 28 PM BMD 0 554 g cm 2 Phantom BMD range 0 539 0 561 Average BMD value 0 551 Average BMD range 0 545 0 556 Precision OK OK Figure 44 Phantom Test Results Screen Based on phantom test results one of the several screens will be displayed At the end of a successful phantom test users have the option of printing the results in report format A Press YES to print the report Pressing Yes displays the Confirm Multiple Copies Screen shown in Figure 25 Up to 9 copies of the report can be printed B Press NO to return to the Welcome Screen Phantom Test passed Remember Please run the phantom test periodically to verify system performance Print YES Report NO Phantom Test passed Important Please run the phantom test immediately to verify system performance Print YES Report NO B7101220 Rev E 37 If the system fails the phantom test a
47. hed Precautions e Federal law restricts this device to sale by or on the order of a physician e The BMD values obtained with this device should be only one factor in a medical judgment that treatment is warranted for a disease or disorder e The accuDEXA compares BMD values to a reference normative database This database reflects the mean for a healthy normal YHN population having the same gender and ethnicity Users are reminded of risks in misinterpretation when comparing a patient s BMD results with a database population of different gender or ethnicity e n accordance with international standard IEC 601 3 General Requirements for Radiation Protection in Diagnostic X ray Equipment use of the accuDEXA shall be limited to no more than 20 patient scans per hour accuDEXA User Guide B7101220 Rev E A Symbols and markings Listed below are the descriptions of the various safety and operational symbols that appear either inside or outside the accuDEXA device SYMBOL DESCRIPTION Indicates the presence of dangerous voltage within the enclosure of the device This voltage may constitute a risk of electric shock voltage when the device is connected to a service outlet This safety issue warning symbol is located on the back panel For additional electrical details see page 46 Indicates an attention to users to consult accompanying documents this User Guide for more information on the device This symbol is loca
48. igure 16 Ethnicity Screen ette pH D UP ORO DOR HR Oen 12 Figure 17 Database Information Screen sss eene trennen trennen reser nne 13 Figure 18 Summary Screen eee ine terne Rete Ret b IR ESEETO e SERE c Ib SEENEN 13 Figure 19 Positioning Screen 14 Figure 20 X ray SCreens A E 14 Figure 21 Bone Outline Screen ssc sos sige verse rata 15 Figure 22 Computing BMD Results Screen ooo eee eee cesecesecnseceecaeecaeecaeeeeeeseseseseneeeaeeseeeeeeneenseessaenee 16 Figure 23 BMD Test Results Screen with t and 3 scores ener 16 Figure 24 BMD Test Results Screen without t and z scores ccoo rennen 16 Figure 25 Multiple Copies Confirmation Screen 17 Figure 26 Multiple Copies Scree ossis eneee snoeien tes eenen EE enne EE E eE TEETE EEE SE enne 17 Figure 27 Printing Copies Screen ooo eee eni Ea ERE a EEE E S E I EIEE a RT REE 17 Figure 28 Example of Densitometry Report with t and z scores oooconocccocconnconcnannnoncnnncnnnconoco noc nccn non enn 21 Figure 29 Example of Densitometry Report without 2 score eene nee 22 Figure 30 Example of Densitometry Report no database available see 23 Figure 31 Configuration Menu Screen oo cece eeeescesecssecsecesecesecesecaeecseeeseesaeeeeeeeeeseensecssecsaecsaecaeecsaeeneeeaes 24 Figure 32 Time SCreen s EE 25 LEUR RE 26 Figure 34 Printer Screen uictor ri RO St ete ERR t Seed 28 Figur 35 Printer Driver Screens teh ie etre eee reet Ene eed Deest IEA A
49. in cancer treatments Low testosterone levels in men A sedentary lifestyle Cigarette smoking Excessive alcohol intake Malabsorption problems 20 B7101220 Rev E accuDEXA User Guide accuDEXA BONE DENSITOMETRY REPORT Date 04 20 00 11 11 AM Version 1 50 04 20 00 NDB 1 1 Unit 1772 Serial 2395 Patient ID 123 Image not for diagnosis Gender Female BMD Test Results BMC 21469 Area 3865cm BMD 0 555g cm Calibration status Passed zscore 0 5 92 Age matched BMD tscore 1 85 Relative to YHN Analysis Normal Based on WHO guidelines Female Caucasian reference curve Legend t score Analysis t gt 1 High BMD 1 gt t gt 1 Normal 1 gt t gt 2 5 Osteopenia t lt 2 5 Osteoporosis SCHICK ECHNOLOGIES ING Figure 28 Example of Densitometry Report with t and z scores accuDEXA User Guide B7101220 Rev E 21 accuDEXA BONE DENSITOMETRY REPORT Date 09 25 00 11 11 AM Version 1 50 09 20 00 NDB 1 1 Unit 1772 Serial 2395 Patient ID 124 Image not for diagnosis Gender Female BMD Test Results Suc 059g 1 674 em 0 356 glem rescore Age out of range rescore 3 68 Relative to YHN Based on WHO guidelines Female Caucasian reference curve Legend Calibration status Passed t score Analysis t gt 1 High BMD 1 gt t gt 1 Normal 1 gt t gt 2 5 Osteopenia t lt 2 5
50. ionary and approximately 18 inches from the floor e The accuDEXA is only accurate and precise within the prescribed temperature and humidity range listed on page 44 Operator checklist The operator is responsible for ensuring the following e An audible signal should be heard for each of the two X ray exposures that occur during the BMD test e The radiation label should be affixed and visible on the front panel and a small indicator X ray Exposure Light should illuminate during each exposure e The accuDEXA performs a system check each time the device is powered on The software also performs an internal calibration before the X ray exposures are taken and before the BMD values are calculated If the system check or the internal calibration is unsuccessful an error message will be displayed on the LCD screen If the problem cannot be corrected write down the error message number if one appears at the upper right portion of the screen and contact Schick Technologies Inc at 888 818 4BMD for assistance accuDEXA User Guide B7101220 Rev E 7 Getting started 1 A On the accuDEXA front panel turn the On Off key switch to On The Welcome Screen appears The System Check Screen appears A Please wait as the accuDEXA performs its internal checks The Sensor Verification Screen appears A Press OK Welcome To lu Please Wait Figure 5 Welcome Screen Running System Check Please Wait
51. l to select it B For now make sure the checkbox for Always use this program to open this type of file is clear You can check this box at a later time if you want to always start Excel when opening a log file C Click OK Li Oi Pl MLE E Open With LET Chick the prograra 104 50 Ep une Go open fae Abe TER T2000 1065 V ise paci pou sand Hr rol in thee kat click Oder Liese the prora vo ead bo use D diaga use thes propin boaren Pis e of fe B7101220 Rev E 3 The Patient Log Report appears in Excel s workbook window At this point a few formatting steps are needed to improve the look and readability of the table A Starting with Column B click and hold down the remaining columns in the table B When the last column in the table is selected release the mouse button The selected columns should remain highlighted Click on the Format menu to open the list of options Click on Cells ar diles a Copa ja jue Pai ee Fre Le a em alli Saas Rum A tinh Nd 0 Ta AAA ee BEKI EN a PAT p HE Aj A A O a ym 1 1130113 EULI EE m t Gba pi c rum fe Uer es gie T Dub ALE pg TEESE EE cma serp AAA AO A atb mim lam a M Hp BH amm ste js es Ers pee gu ed Sai Format Row gt Column b Sheet b AutoFormat Conditional Formatting Style 54 B7101220 Rev E accuDEXA User Guide The Format Cells dialog box appe
52. le menu to open the list of options Click on Page Setup ssdsH xh EE Hg The Page Setup dialog box appears A Under Orientation click on Landscape B Under Margins delete the measurement in each text box As the measurements are deleted new minimum margin values will appear in the text boxes Leite H 13 c n C Click OK accuDEXA User Guide B7101220 Rev E 57 A Click on the File menu and then on Save As B When the dialog box opens name the file and select Text Document from the Save as type drop down box When saving the file make sure you save it to your hard drive C Click Save Your data has now been saved as a text document in WordPad Jara Ai ETA GIS Tagen zi ammi 58 B7101220 Rev E accuDEXA User Guide Appendix C Error messages If a problem occurs during any procedure the accuDEXA immediately displays an error message The messages are brief and describe the cause of the problem Some error messages may also include an error message number located above the message and on the right Refer to the sample below Error 114 Error Timed out waiting for switch to be hit OK Figure 54 Error Message Screen Users may be able to correct errors reported by accuDEXA Errors that occur during patient data entry data transfer or printing can often be fixed easily If the problem persists however please write down the error mess
53. libration file Initialization file filename cannot be read System file filename failed system check 142 Could not read lt filename gt to perform system check Cannot read wedge data in setup file Cannot read data in normative database 135 129 134 150 142 145 133 135 Hardware Errors 103 168 152 112 128 32 01 01 03 16 17 Switch closed prematurely Possible hardware problem Incorrect X ray exposure Please reposition hand 168 114 Timed out waiting for switch to be hit No finger detected or x ray source error Timed out waiting for limit switch and or filter motion X ray energy or filter failure Sensor or high energy X ray emission failure Sensor or low energy X ray emission failure Filter solenoid and or limit switch failed system check Filter solenoid status unknown Filter solenoid and or limit switch failed system 1 check Hard tissue equivalent linear wedge calibration 1 failure Soft tissue equivalent linear wedge calibration 1 failure 60 B7101220 Rev E accuDEXA User Guide Error Can be May be Cannot be Error Message Message corrected corrected corrected Number by user by user by user Aluminum step wedge calibration failure Cannot store images System Check Errors System temperature too cold 70 85 F 21 29 C only System temperature too hot 70 85 F 21 29 C only Wedge verification error Please make sure the hand slot is empty Senso
54. n out of range message is displayed and the phantom test is repeated If the system fails this second test as well you will not be able to perform BMD tests Some features however like retrieving and printing patient data will be available Errorit xxx Phantom Test failed System malfunction Call Schick Technologies Technical Support Contact us at 888 818 4BMD for OK further assistance Click OK 38 B7101220 Rev E accuDEXA User Guide accuDEXA QC PHANTOM TEST REPORT Date 09 25 00 11 11 AM Version 1 50 09 20 00 NDB 1 1 Unit 1772 Serial 2395 Image not for diagnosis QC Phantom Test Results BMC Areas 2 302 cm ok Precision Calibration status Passed QC Phantom Test Graph BMD o 0 561 Top limit QC limit Reference BMD QC limit Bottom limit 18 19 20 21 22 23 24 25 26 27 Phantom test number NOTE Phantom BMD must be within top bottom limits QC Average BMD must be within QC limits P f SCHICK TECHNOLOGIES ING Figure 45 Example of Phantom Test Report accuDEXA User Guide B7101220 Rev E 39 Performing a system test Follow this procedure to run a system check of your accuDEXA unit This test initiates several internal checks that are similar to those performed automatically on start up Some checks performed only when the accuDEXA is turned on are not repeated by the system test 1 If the accuDEXA is not on already turn Welcome To
55. oning Screen 38 Report Before Available Reference BMD 70 Report Details 42 Results Screen and Standard 69 Understanding Phantom Test Results 36 Please Wait Screen 39 Positioning Screen 18 Print Data Screen 53 Printer Changing 31 Compatibility and Codes 68 Connections 8 Installation 7 Print Test Page Screen 34 Troubleshooting for Canon 67 Printer Driver Changed Screen 33 Printer Driver Screens 32 Printer Screen 32 Printing a Test Page 33 Printing Copies Screen 21 R Reference BMD Calculating 69 Reference Information 48 Release Button Screen 13 S Screen Navigation 10 Sensor Verification Screen 12 13 Software New Features 9 Upgrade 9 Standard Deviation Definition of 72 Static Electricity 47 Summary Screen 17 Symbols B System Checks 46 System Check Screen 12 34 44 System Test Passed Screen 45 System Check Screen 34 38 44 System Test Steps to Perform 44 T Technical Description 48 Test Page 35 Text Conventions 9 The accuDEXA Device back view 7 The accuDEXA Device front view 7 Time Additional Details 29 Changing 28 Time Screen 29 Touch Screen 10 Transfer Complete Screen 55 Transfer Confirmation Screen 54 Transfer Date Screens 54 Transfer in Process Screen 55 t score 5 Definition of 72 Using 5 t scores z scores fracture risk Calculations 22 V Verification Test Results Screen 14 WwW Welcome Screen 12 14 15 2
56. oporosis Foundation Exerpta Medica 1998 accuDEXA User Guide B7101220 Rev E 1 National Osteoporosis Foundation fax number 202 223 2237 Monitoring Changes in Bone Mineral Density BMD is an appropriate parameter by which to monitor changes in bone mineral density effected by drug therapy or aging Physicians should compare results of BMD tests taken on a patient over a period of time with the reported accuDEXA precision repeatability To determine whether a significant change in BMD has occurred physicians must calculate the percentage change in results over time according to the following formula change BMD previous exam BMD current exam BMD previous exam 100 The information below will help the physician determine the statistical significance of the BMD test result changes As a general rule a greater than 1 8 difference in BMD results would indicate consequential change Percentage Change in BMD Level of Statistical Significance 2 77 95 2 33 90 1 84 85 These values are based on accuDEXA s published precision of 1 Indications The Society of Nuclear Medicine and American College of Nuclear Physicians has identified specific medical indications that warrant the evaluation of a patient s bone density Below normal bone density can be associated with a variety of bone conditions or disorders Some of the more common conditions associated with below normal bone density include e Premenopausal oo
57. page 6 A Press OK and proceed to next step OR B Press CANCEL to terminate the BMD test All entries will be deleted and the Welcome Screen will appear Position patient hand now Figure 19 Positioning Screen The first X ray screen appears Wait for the X ray Enable light to turn on Perform steps A through E to take the X ray or perform step F to reposition the patient s hand or to terminate the BMD test A Press and hold down the X ray Enable button B Listen for two beeps Each beep represents an X ray exposure and there is approximately a 5 second pause between each beep During the beep the X ray Exposure light turns on momentarily C Release the button when the Release button message appears D Lower the lever knob and instruct the patient to remove his her hand E Wait for an X ray image to appear on the display as shown in step 11 OR F Press CANCEL You can either resume testing by repositioning the patient s hand or terminate the BMD test entirely If you choose to terminate the test the Welcome Screen will re appear Ready to take x ray Push and hold down X RAY ENABLE button Release button Remove patient s hand Reading reference frames Figure 20 X ray Screens 14 B7101220 Rev E accuDEXA User Guide PLEASE NOTE If the patient s hand is removed during the X ray process or was not positioned properly the
58. phorectomy Spontaneous menopause or estrogen deficiency conditions Treatment related osteopenia when the diagnosis of osteopenia is suggested or established by other means such as X ray during long term immobilization e Endocrinopathies associated with osteopenia for post gastrectomy and other malabsorption states leading to osteopenia during long term corticosteroid therapy e Chronic renal disease particularly in childhood or adolescence In addition to the above BMD values can be used to monitor longitudinal changes as with treatment programs for osteoporosis Contraindications e A deformity that prevents a patient s non dominant hand from being properly positioned e Orthopedic hardware in the middle finger of the non dominant hand e Previous fracture of the middle finger of the non dominant hand e Pregnancy Although the radiation exposure from an accuDEXA BMD test is 1 150 000 of a chest X ray any radiation exposure during pregnancy must be deemed medically necessary by a physician Known adverse reactions None 2 B7101220 Rev E accuDEXA User Guide Controls and indicators Identified on the following figures are the external features of the accuDEXA device ON OFF KEY SWITCH SHOWN IN ON POSITION TOUCH SCREEN CARRYING SLOT X RAY EXPOSURE ON OFF INDICATOR LIGHT X RAY ENABLE elt BUTTON LIGHT BMD Assessment System WARNING LABEL VIEWING WINDOW HAND SLOT HANDLE KNOB FAN PARALLEL
59. pply some basic technical information to the state radiation board In the following table we have included information to help you respond to those questions correctly More detailed specifications may be found in the Specifications and Electrical Summary tables on pages 45 and 46 respectively of this manual Maximum kVp 70 kVp Check the product label near the fan on the Serial number back of your unit 6 1 mR h at 1 meter distance pester ta Manon Time of two DEXA pulses is 60 and 90 milliseconds Absorbed dose 3E 4 uSv per scan Effective radiation Number of tubes Check the regulatory label near the X ray headinumbper electrical inlet on the back of your unit accuDEXA User Guide B7101220 Rev E C This page intentionally left blank D B7101220 Rev E accuDEXA User Guide accuDEXA overview and setup Overview The accuDEXA is a dual energy X ray device that estimates the bone mineral density BMD of the region of the third finger of the non dominant hand Finger BMD is a relative indicator of bone density in other parts of the body The t score and z score The accuDEXA reports an individual s relative BMD status by calculating a t score and z score This calculation is performed automatically by the accuDEXA and can be viewed on screen and or printed out at the conclusion of an exam For a concise definition of t and z scores please refer to the glossary on page 68 The t score or z score is often used by
60. r verification error Please make sure the hand slot is empty Sensor verification error X ray source failure or switch was not pressed Could not run system check on system file 151 lt filename gt Filter solenoid and or limit switch failed system Could not read lt filename gt to perform system check Sensor verification error Sensor connection 171 failure Sensor malfunction 173 Sensor failed system check General Errors 113 Memory failure 130 149 148 169 170 172 System file lt filename gt failed system check 142 108 145 173 41 Internal error accuDEXA User Guide B7101220 Rev E 61 Notice messages Notice messages perform two functions to confirm the user s action to cancel interrupt or continue with a procedure and to indicate prior to X ray scans when t or z scores cannot be provided in the BMD Test Report Acquisition canceled upon request from user Data transfer interrupted by the user Timed out waiting for switch to be hit No finger detected Age is outside range of normative database for specified gender and ethnicity No z score possible Normative database not installed for specified gender and ethnicity No t score or z score possible 62 B7101220 Rev E accuDEXA User Guide Appendix D Troubleshooting the Canon printer The following list summarizes typical solutions in the event you experience printing problems with the Canon BJC 250
61. rrect the problem check and or replace the printer cable If the accuDEXA touch panel displays the error Note Could Not Print Check that the printer cable is properly connected between the accuDEXA unit and the printer You may need to replace the printer cable Check the printer cartridge It may need to be replaced Try printing a test page from the printer If the printer is able to print a test page but not an accuDEXA printout you may need to service the accuDEXA unit accuDEXA User Guide B7101220 Rev E 63 Appendix E List of printers The following table lists the printers compatible with the accuDEXA device and the codes required when changing printers Non compatible printers are also noted in the following table Compatible with Printer Time to Print EES Mogel accuDEXA Code BMD Report E o Laser Printer HL 1240 Yes 13 30 seconds a BJC 250 Yes 1 2 minutes c BJC 4000 LQ Yes T kE SS BJC 300 Yes 8 e LBP 465 Yes 9 30 seconds BJC 1000 2000 2100 3000 5100 6000 8200 Not Compatible 400 S450 S o InkJet IJ 300 13 600 IJ 3750 IJ 1200 Not Compatible 3 Stylus Color 440 Yes 4 2 minutes Stylus Color 740 800 850 900 Yes 4 1 minute S Action Laser II Yes 5 TA m Action Laser 1600 Yes 6 Ka EPL N2000 Yes 14 ZS Stylus Color 640 860 Not Compatible LaserJet Series II III IV Yes 2 30 seconds T DeskJet 610CL
62. s used by the accuDEXA As databases for other ethnicities and genders become available these databases will be incorporated into the accuDEXA by software upgrades The Hispanic database is representative of individuals living in Latin America and the United States accuDEXA User Guide B7101220 Rev E 47 Appendix B Printing and copying the Patient Log Report Follow this procedure to print the Patient Log Report or to copy it to floppy disk The Patient Log Report consists of patient information BMD and BMC scores and t and z scores X ray images and BMD report graphs are not included After performing the procedure a single log file is generated including test results from the range of dates one day or many specified by the user An example of the Patient Log Report is provided in Figure 53 If the accuDEXA is not on already turn the On Off key switch to On The Welcome Screen appears Ey A Touch any part of the Welcome d Welcome To Touch anywhere to begin The Main Menu Screen appears A Press Configuration Main Menu BMD Test Configuration System Check 3 The Configuration Menu Screen appears Configuration Menu BACK Current time date A Press Patient Log 05 11 00 11 47 AM Change Time Change Date Change Printer Patient Log 48 B7101220 Rev E accuDEXA User Guide The Patient Log Selection Screen appears Press Print if you want to print accuDEXA Patient Lo
63. screen B Press Change Time Configuration Menu BACK us Current time date 05 11 00 11 47 AM Change Time Change Date Change Printer Patient Log Figure 31 Configuration Menu Screen 24 B7101220 Rev E accuDEXA User Guide The Time Screen appears A Enter a four digit time value PLEASE NOTE The accuDEXA uses a twenty four hour clock HHMM The user must enter two digits for the hour and two digits for the minute If an entry has Enter time HHIVIM BACK only one digit 0 9 a zero must be added in front of it 00 09 Below are some examples 1 2 3 OK Ifthetimeis Enter To Display 9 30 PM 2130 9 30 PM Noon 1200 12 00 PM S z z E Midnight 0000 12 00 AM B Press OK The Configuration Menu Screen will re appear with the revised time Figure 32 Time Screen TIP If you entered the wrong time press CLEAR and re enter Changing the date If the accuDEXA is not on already turn the On Off key switch to On The Welcome Screen appears Welcome To A Touch any part of the Welcome DEA Touch anywhere to begin accuDEXA User Guide B7101220 Rev E The Main Menu Screen appears A Press Configuration Main Menu BMD Test Configuration System Check 3 The Configuration Menu Screen appears Configuration Menu BACK Current time date A Note where the date and time 05 11 00 11 47 AM appear on the screen B Press Change Date Change Time Change Date Chang
64. stalled in the accuDEXA Suggestions provide usage hints or reminders accuDEXA User Guide B7101220 Rev E 5 Using accuDEXA The touch screen The operator enters information and initiates a BMD test by using the touch sensitive LCD screen The touch screen reacts to the contact of the operator s finger and only minimal pressure a simple light touch or a tap is necessary The touch screen will not respond if the operator is wearing a glove Screen navigation A description of some of the on screen features of the accuDEXA appear below using the Age Screen as an example Enter Patient Age BACK returns you to the previous menu OK accepts the entry and advances to the next screen CLEAR deletes the entry from the screen Use this feature to re enter information Finger placement 1 Push down the handle knob This will raise two levers located in the hand slot Instruct the patient to place their non dominant hand inside the hand slot If the patient is right handed they should place their left hand into the hand slot If the patient is left handed they should place their right hand into the hand slot The patient s hand must be placed palm down and rest as far forward as possible Refer to the following figure The hand must contact the pegs at both sides of the middle finger at points A and B The middle finger must rest firmly against the guard at C Figure 4 Finger Placem
65. sts the phantom BMD must fall within the 0 52 and 0 58 range Standard Deviation SD A measure of the spread of a distribution In a normal or bell curve distribution 68 of all estimations lie within one standard deviation of the mean and 95 of all measurements lie within two standard deviations of the mean t score A measure of a patient s BMD compared with a young healthy normal population ages 20 29 of the same gender and ethnicity The t score is reported in terms of the number of standard deviations above positive t score or below negative t score the mean reference BMD World Health Organization WHO A specialized agency of the United Nations promoting technical cooperation for health among nations and the improvement in the quality of human life Young Healthy Normal YHN A population sample defined as young healthy normal adults ages 20 29 of the same gender and ethnicity z score A measure of how the BMD of an individual patient compares with the BMD of a reference population of the same age group gender and ethnicity The z score is the number of standard deviations above positive z score or below negative z score the mean BMD of an age matched control 68 B7101220 Rev E accuDEXA User Guide A accuDEXA Electrical Summary 50 General Information A Indications A Overview 5 Precautions A Registering C Specifications 49 Steps to Turn Off 8 Steps to Turn On 8 Steps to Turn On 8 W
66. t for additional printers Software upgrade procedure To upgrade the accuDEXA with the latest software release perform the following procedure PLEASE NOTE To maintain reliable system performance do not install older versions of accuDEXA software after upgrading your unit If necessary power down the accuDEXA by turning the On Off key clockwise to Off Insert the upgrade diskette into the disk drive located in the back panel Power up the accuDEXA by turning the On Off key counter clockwise to On indicator illuminates The new software will be installed automatically Wait for the message Upgrade is complete Remove the upgrade disk Power down the accuDEXA by turning the On Off key switch clockwise to Off Pause for ten seconds Power up the accuDEXA by turning the On Off key counter clockwise to On 9e ps 9 Ho e Conventions used in text Several text conventions are used in this manual to emphasize the text displayed on the touch screen and to provide additional help and information in the procedural areas The names of menu screens and the wording Main Menu Screen Ethnicity Screen BMD on the LCD screen display are shown in bold Test Change Printer OK Cancel etc when they appear in text TIP If you enter the wrong ID press CLEAR and re enter the number us PLEASE NOTE Items of special note provide additional user information or instruction If a particular ethnicity is not listed it is not in
67. ted on the accuDEXA back panel and on the finger phantom Indicates the ON position of AC power located on the front panel Indicates the OFF position of AC power located on the front panel Indicates the point where the safety ground wire or protective earth connector connects inside the accuDEXA gt HO gt gt Indicates that the accuDEXA is a Class B diagnostic device This label is placed on the back panel To protect against electrical shock the accuDEXA device is grounded with a three prong cable and plug Insert this power cable only into a properly grounded three contact outlet Please do not remove the protective cover of the accuDEXA device Since there are no serviceable parts all internal adjustments and replacements must be made by the manufacturer e Always disconnect the system from the power source before moving or cleaning e The accuDEXA device uses low X ray dosage Please refer to your state or national regulator regarding radiological safety procedures and precautions B7101220 Rev E accuDEXA User Guide Registering your accuDEXA In most areas of the United States users will be required to register the product with their states radiation board To facilitate registration we have provided a list of contacts that you may find helpful This list can be found in the documentation kit supplied with your unit In order to register your accuDEXA you will need to su
68. to begin 2 The Main Menu Screen appears A Press BMD Test Main Menu BMD Test Configuration System Check Figure 12 Main Menu Screen The Patient ID Screen appears A Enter the patient s identification number The patient s ID number can Enter Patient ID BACK have a maximum of ten digits The ID can be a social security number i 3 ES hospital chart number or an ID number defined by the operator 4 2 g e 7 8 9 CLEAR B Press OK Figure 13 Patient ID Screen TIP If you enter the wrong ID press CLEAR and re enter the number accuDEXA User Guide B7101220 Rev E 11 The Age Screen appears A Enter the patient s age The age can be a maximum of 3 digits and can range from 1 to 120 years B Press OK TIP If you enter the wrong age or an age outside the range of 1 to 120 press CLEAR and re enter the number The Gender Screen appears A Select the patient s gender Enter patient age BACK 1 2 3 OK 4 5 6 0 7 8 9 CLEAR Figure 14 Age Screen Enter gender BACK Female Male Figure 15 Gender Screen 6 The Ethnicity Screen appears A Select the patient s ethnicity Enter ethnicity BACK Caucasian Asian Hispanic African American Other Figure 16 Ethnicity Screen 12 B7101220 Rev E accuDEXA User Guide The Database Information Screen shown at right appears only if a normative database is not available
69. uest from the insurer or for personal record keeping Even if an insurance carrier does not request this report we recommend performing the test at least weekly Understanding phantom test results With the release of software version 1 50 the phantom test report has been expanded to provide additional information about system performance This information is grouped in two areas QC Phantom Test Results and QC Phantom Test Graph Samples of the phantom test report can be found on Figure 40 and Figure 45 The QC Phantom Test Results table summarizes the results from the current phantom test and reports other information on the status of BMD testing The result of the current phantom test is called Phantom BMD and is an indicator of how well the system compares to pre defined limits in accuDEXA s configuration file This is one measure of system performance A second measure QC Average BMD considers both the current and previous Phantom Test results QC Average BMD is a moving average the result of averaging the last 10 Phantom BMD values For this reason QC Average BMD is a good indicator of how closely the system is performing to its baseline value Reference BMD If QC Average BMD is listed as Not Available n a on your printed report refer to Appendix F Calculating Reference BMD on page 65 The QC Phantom Test Graph is plotted below the test results table To review the graph it is necessary to print the phantom report as
70. ully B Press OK C When the Configuration Menu Screen appears press BACK D The Main Menu Screen appears Now you can perform BMD tests using the new printer Figure 36 Printer Driver Changed Screen Printing a test page PLEASE NOTE If the print quality of your test page is poor you may have the wrong printer driver selected for your printer Refer to the section on Changing the printer to verify your printer is using the correct driver 1 If the accuDEXA is not on already turn the On Off key switch to On The Welcome Screen appears Welcome To A Touch any part of the Welcome Ev Screen d Touch anywhere to begin 2 The Main Menu Screen appears A Press System Check Main Menu BMD Test Configuration System Check accuDEXA User Guide B7101220 Rev E 4 The System Check Menu appears A Press Printer Test The Print Test Page Screen appears A Press YES to print a test page The test page will print only the following items e Print date and accuDEXA equipment information at the top of the page to evaluate the readability of text e Schick Technologies logo at the bottom of the page to evaluate the print quality of graphics OR B Press NO The Main Menu Screen will appear TIP If test page printing fails the first time check the printer cable connections and the paper tray The system will try to print the test page a second time If the task fails
71. ure range If this is the first time you are turning on the accuDEXA let the unit acclimate to the indoor temperature for at least 30 minutes before turning it on If a temperature error occurs adjust room temperature let the unit re acclimate and try again If the error occurs again contact Schick Technologies for assistance 1 Ensure that the accuDEXA the printer and the printer power supply depending on the printer used with the system are connected to each other and the A C service outlet 2 Insert the key into the On Off key switch and turn it counter clockwise to On 3 The On Off indicator illuminates and after approximately 60 seconds the Welcome Screen appears on the display Turning off the accuDEXA 1 Insert the key into the On Off key switch if it is not inserted already and turn it clockwise to Off 2 The On Off indicator will turn off and the display screen will clear PLEASE NOTE Turn off the accuDEXA at the end of every day and whenever it is not in use 4 B7101220 Rev E accuDEXA User Guide New features in software version 1 50 The new software release for accuDEXA includes the following features New data ages 80 to 89 for FEMALE ASIAN database New Latin American data ages 80 to 89 for FEMALE HISPANIC database New sensor verification test for determining system effectiveness on start up New quality control test for current and ongoing review of system performance New Patient Log Report Suppor
72. using hip DXA as the gold standard the Bone Measurement Institute s suggested threshold of t lt 1 0 results in good test sensitivity and moderate test specificity Nevertheless those who chose to use the accuDEXA to make treatment decisions may choose a somewhat lower T score threshold of 2 0 The National Osteoporosis Foundation suggests initiating drug therapy in women with t scores below 2 in the absence of risk factors and in women with t scores below 1 5 if other risk factors are present Whatever intervention level you choose be aware that no single site BMD measurement will agree diagnostically with other measurements 100 of the time For more information about osteoporosis and using t scores in your practice please fax your request for the Physician s Guide to Prevention and Treatment of Osteoporosis to the Miller PD Bonnick SL Johnston CC Kleerekoper M Lindsay R Sherwood LM Siris E The Challenges of Peripheral Bone Density Testing Which Patients Need Additional Central Density Skeletal Measurements Journal of Clinical Densitometry 1 3 211 217 Mulder JE Michaeli D Flaster ER Siris E A Comparison of Bone Mineral Density of the Phalanges with Bone Mineral Density of the Lumbar Spine Hip and Forearm for the Assessment of Osteoporosis in Postmenopausal Women Journal of Clinical Densitometry December 2000 in press a Physicians Guide to Prevention and Treatment of Osteoporosis National Oste

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