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Omnisense 7000S/8000S

2-1

CHAPTER 2

Essential Prescribing Information

The Sunlight Omnisense

®

7000S/8000S Ultrasound Bone

Sonometer is an accurate and easy to use tool for assessing the
condition of bone. This chapter provides an introductory over-
view of the Omnisense system and the Information for Pre-
scribers.

2.1 Device Description

The Sunlight Omnisense

®

7000S/8000S (Omnisense) Ultra-

sound Bone Sonometer is a non-invasive ultrasound device
capable of measuring bone speed of sound (SOS) at one or
more skeletal sites. It is comprised of a main unit and small
hand held probes, each designed to measure SOS at one or more
specific skeletal sites. The basic system is offered with one
probe, capable of measuring SOS of the distal one-third radius.
Additional probes may be added, capable of measuring SOS at
the proximal phalanx III or metatarsal V. Reference databases
are provided for measurements at each of the skeletal sites and
for different genders. See 2.11, "How Supplied‚" page 2-24 for
a complete list of accessories.

Omnisense measures SOS utilizing a technology based on well-
established laws of physics applied to the transmission of sig-
nals along the bone. The measurements are performed while the
subject and the operator are comfortably seated.

A brief description of SOS measurements at the distal one-third
radius, proximal phalanx III, and the metatarsal V are provided

Caution

: U.S. Federal Law restricts this device to sale by or

on the order of a physician (or properly licensed

practitioner).

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Summary of Contents for Sunlight Omnisense 7000S

Page 1: ...Sunlight Omnisense 7000S 8000S Bone Sonometer User Guide U S Software Version 2 2 DUM 0049 Revision 02 ...

Page 2: ...00S 8000S is a trademark of BeamMed Ltd Other reg istered trademarks or trademarks are the property of their respective owners The Quality Management System of BeamMed Ltd complies with the Quality Management Standards ISO13485 2003 MDD 93 42 EEC and FDA QSR requirements Israel BeamMed Ltd 8 Halapid Street P O Box 7520 Petach Tikva 49170 Israel Tel 972 3 9236869 Fax 972 3 9236867 0344 ...

Page 3: ...us your comments and suggestions Contact us at the addresses and telephone numbers below BeamMed Ltd 8 Halapid Street P O Box 7520 Petah Tikva 49170 Israel Tel 972 3 9236869 Fax 972 3 9236867 e mail info beammed com Our Authorized European Representative CEpartner4U BV Esdoornlaan 13 3951 DB Maarn The Netherlands Phone 31 343 442524 Fax 31 343 442162 ...

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Page 5: ...se the Software solely on the equipment on which it is installed at time of delivery or on the equipment for which it is intended to be installed if not installed when deliv ered for as long as purchaser shall own such equipment The Software may be used for performing measurements on this equipment in the normal course of the purchaser s business but for no other purpose or business No license is ...

Page 6: ...d the Company shall either repair the Product or replace it with a new Product or equivalent at its sole discretion If the Company is unable to repair or replace a defective Product it shall refund the Product s purchase price to the customer provided that the customer has returned the Product to the Company Any transport costs will be paid by the customer Any Product so replaced or repaired shall...

Page 7: ...nauthorized modification or misuse of the Product d Operation outside the range of the environmental specifications of the Product e Improper site preparation or maintenance f Accidental damage whether in transit or otherwise 3 Except as provided for in this warranty neither the Company nor any of its suppliers makes any other warranties whether express or implied and whether statutory or otherwis...

Page 8: ...stributor s Name and Address____________________________ ______________________________________________________ Sunlight Omnisense 7000S 8000S Model _________ Serial Number _______ Ultrasound Probe s Type _____ Serial Number _____________ Type _____ Serial Number _____________ Type _____ Serial Number _____________ Date of Purchase_________ Name___________________ Signature________________ ...

Page 9: ...ose 3 Protection of Intellectual Property a The Product is protected under national and international copyright trademark and trade secrecy law The Product or components thereof may be protected under national and international patent laws All right title and interest to the Software shall remain with the Distributor and its supplier and or licensor The License granted herein does not constitute a...

Page 10: ...all survive the termination of this Agree ment c The Distributor and or its supplier and or licensor shall have the right but not the obligation to defend or settle at their discretion any legal action against the End User arising from a claim that the End User s permitted use of the Product under this Agreement infringes any patent copyright or other ownership rights of a third party The End User...

Page 11: ...OEVER INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF BUSI NESS PROFITS BUSINESS INTERRUPTION LOSS OF BUSINESS INFORMATION OR ANY OTHER PECUNIARY LOSS ARISING OUT OF THE USE OF OR INABILITY TO USE THE PRODUCT EVEN IF IT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES Because some states and jurisdictions do not allow the exclusion or limitation of liabil ity for consequential or incidental da...

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Page 13: ...2 5 2 5 Precautions 2 5 2 6 Adverse Events 2 7 2 7 Clinical Studies 2 7 2 8 Individualization of Treatment 2 17 2 9 Patient Counseling Information 2 22 2 10 Conformance to Standards 2 22 2 11 How Supplied 2 24 2 12 Operators Manual 2 25 2 13 References 2 25 3 Introducing Sunlight Omnisense 7000S 8000S 3 1 3 1 Quantitative Ultrasound 3 1 3 2 Omnisense Technology Omnipath 3 2 3 3 Relationship betwee...

Page 14: ... 24 4 11 Setting the System Time 4 25 4 12 Setting System Default Options 4 27 4 13 New User Entry 4 28 4 14 Additional Applications 4 29 5 Working with Omnisense 5 1 5 1 Basic Operations 5 1 5 2 Changing Users and Shutdown 5 12 6 System Quality Verification 6 1 6 1 About System Quality Verification 6 1 6 2 Performing System Quality Verification 6 2 7 Patient Files 7 1 7 1 Patient Files 7 1 7 2 Op...

Page 15: ...ement Results 9 1 9 2 Deleting a Measurement Result 9 7 9 3 Measurement History 9 8 9 4 Measurement Report 9 11 10 System Administration 10 1 10 1 User Access Levels 10 1 10 2 Setting System Default Options 10 6 10 3 User Interface Language Selection 10 16 10 4 Patient Management 10 19 10 5 Probe Quality History 10 21 10 6 Changing Site Order 10 23 10 7 Extending or Upgrading an Omnisense License ...

Page 16: ...easurement Methodologies 15 1 15 1 Distal 1 3 Radius 15 1 15 2 The Proximal Phalanx of the Third Finger 15 1 15 3 Metatarsal V 15 7 15 4 Practice Mode 15 12 16 Utilities and Peripherals 16 1 16 1 Import and Export of Patient Data 16 1 16 2 Data Conversion 16 6 16 3 Backup Restore 16 9 16 4 Print Setup 16 13 16 5 Disk Utilities 16 15 16 6 Other Utilities 16 20 16 7 Logger 16 21 16 8 System Upgrade ...

Page 17: ...ing with Reference Databases 17 9 18 Keyboard Shortcuts 18 1 18 1 How to Use Help 18 1 18 2 Selecting Items in a Dialog Box 18 2 18 3 Using Menus 18 3 18 4 Using Dialog Boxes 18 4 18 5 Editing Text in a Text Box or Window 18 5 18 6 Moving Around 18 5 ...

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Page 19: ... dialog box 4 20 Figure 4 13 User List screen 4 22 Figure 4 14 Change password dialog box 4 22 Figure 4 15 Adding users with the User List screen 4 24 Figure 4 16 System Options dialog box Settings screen 4 25 Figure 4 17 Time Zone screen 4 26 Figure 4 18 Date Time settings 4 27 Figure 4 19 New user access to Omnisense 4 28 Figure 4 20 Setting a new password with the List of Users screen 4 29 Figu...

Page 20: ... Hand rest and correct patient positioning 8 17 Figure 8 9 Applying ultrasound gel 8 18 Figure 8 10 Scanning the radius 8 19 Figure 9 1 SOS measurement result screen 9 1 Figure 9 2 Suggest to re measure pop up box 9 4 Figure 9 3 Warning before discarding measurement result 9 5 Figure 9 4 Patient risk assessment 9 6 Figure 9 5 Patient measurement details 9 7 Figure 9 6 Patient measurement delete me...

Page 21: ...ion prior to marking the ROI 15 8 Figure 15 10 Marking the distal end of metatarsal V 15 8 Figure 15 11 L Gauge for use with metatarsal V 15 9 Figure 15 12 Marking the scan region with the L gauge 15 9 Figure 15 13 Scanning the metatarsal V 15 11 Figure 15 14 Accessing the Practice Mode 15 12 Figure 15 15 Practice Mode warning 15 12 Figure 16 1 Import dialog box 16 2 Figure 16 2 Export dialog box ...

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Page 23: ...f reading the material for different pur poses The Omnisense system provides on line help which has the same structure as this Guide To enter Help choose Help Help Topics from the menu bar The following screen will be displayed You may find the on line help more convenient for day to day work with Omnisense CHAPTER 1 Using this Guide Chapter summaries recommended reading order and con ventions use...

Page 24: ...and general navigational aid CHAPTER 6 System Quality Verification A daily procedure to insure correct functioning of probes and validity of SOS results CHAPTER 7 Patient Files This chapter describes patient files and shows how to create a new patient file and open an existing patient file CHAPTER 8 Patient SOS Measurement General procedure for SOS measurement presented using the distal 1 3 radius...

Page 25: ...s or her measure ment quality CHAPTER 16 Utilities and Peripherals Describes utilities provided with Omnisense for connecting to printers importing and exporting patient data backing up and restoring a system data storage operations and soft ware upgrade CHAPTER 17 Research Mode The Sunlight Omnisense 7000S 8000S Research version provides support for the investigation of new skeletal sites and the...

Page 26: ...llowing Chapter 9 Interpreting the Results of a Measurement You will need to get an operator or physician ID and a password from your Sys tem Administrator to enter the Omnisense software interface A quick reading of Chapter 5 Working with Omnisense will result in a better understanding of the overall structure of the Omnisense software System Quality Verification must be performed daily this is c...

Page 27: ...hat it has recorded an SOS value This process is called a measurement cycle To ensure consistency and reliability each SOS result is obtained by averaging results from at least three measurement cycles In summary the site is scanned repeatedly to complete a mea surement cycle The examiner conducts a number of measure ment cycles each cycle yields an intermediate SOS value The intermediate values o...

Page 28: ...cedures Notes and Warnings Throughout this User Guide you will find Procedures a sequence of steps that are to be performed when using a certain feature or function of the Omnisense Sonometer Procedures begin with a Procedure heading and will be followed by num bered steps in the following format This is a Procedure Heading STEP 1 Name of first step in Procedure Explanation of first step in Proced...

Page 29: ... windows as they appear when using the Omnisense software are found throughout this Guide Screens are preceded by a rule and caption header You can find out how to enter and exit a screen by looking at the far right of the figure just above and just below the screen respectively The screen format is illustrated below Figure 1 1 Example screen Administration User List This line indi cates how to en...

Page 30: ...by the exam ples below Administration User List means choose the item User List from the Administration menu Patient Show History or Toolbar History means there are two ways to enter either select Show History from the Patient menu or click on the History but ton on the toolbar Measure Start means enter Measure ment Mode and then click on the Start button ...

Page 31: ...elate to safety requirements and standards and are briefly reviewed below Table 1 1 International Symbols on Omnisense Symbol Meaning Attention consult accompanying docu ments Type B equipment symbol CE Mark Indicates the Sunlight Omnisense 7000S 8000S complies with both the European Electromagnetic Com patibility EMC standard and the Council Directive 93 42 EEC MDD 0344 ...

Page 32: ...Omnisense 7000S 8000S 1 10 Conventions Used in this Guide ...

Page 33: ... basic system is offered with one probe capable of measuring SOS of the distal one third radius Additional probes may be added capable of measuring SOS at the proximal phalanx III or metatarsal V Reference databases are provided for measurements at each of the skeletal sites and for different genders See 2 11 How Supplied page 2 24 for a complete list of accessories Omnisense measures SOS utilizin...

Page 34: ...ch is comprised of 15 20 bone scans SOS Measurement of the Proximal Phalanx III The CS probe is used to measure SOS along the proximal phalanx III of the hand The positioning of the proximal phalanx III is located and measured in relationship to the length of the medial phalanx using the L gauge provided with Omnisense The area of the skin surrounding the proximal phalanx is marked forward of the ...

Page 35: ...e measurement mode A uniform layer of Parker Gel is then applied to the hand held probe and the measurement area The probe is placed in a parallel position to the bone with the probe s long axis aligned and centered with the long skin line marking and the probe s short edge parallel to and proximal along the short skin line marking The probe is moved in a direction perpendicular to the long mark f...

Page 36: ...k factors as an aid to the phy sician in the diagnosis of osteoporosis and other medical condi tions leading to reduced bone strength and ultimately in the determination of fracture risk Multiple skeletal site testing pro vides clinicians with alternatives if one site is not accessible and with additional skeletal information e g from bones with different combinations of cortical and cancellous ma...

Page 37: ...h the probe Use Omnisense only indoors in a clean dry environment To prevent fire or electric shock do not open or expose the Omnisense main unit to rain or moisture Do not operate or store Omnisense near a heat source or air conditioner and always store the System Quality Verifica tion SQV phantom near the Omnisense main unit The system is not sterile Thus the probe must be cleaned and disinfecte...

Page 38: ...a soft cloth that is lightly moistened with liquid detergent or mild soap that is suitable for cleaning of electrical equip ment SQV phantom and probes should not be immersed in liquid of any kind Alcohol free dry or pre moistened wipes may be used to clean the SQV phantom and probes Do not use scrubbing materials or hard brushes that will scratch the surfaces Do not use cleaning agents such as am...

Page 39: ... contact of the probe with the phantom Refer all service problems to qualified BeamMed representa tive only Monitors printers and other interfacing accessories used with the Omnisense Bone Sonometer must meet IEC 601 1 IEC 950 UL 2601 or equivalent safety standards 2 6 Adverse Events No adverse events were reported in the course of the clinical studies performed in which a total of approximately 3...

Page 40: ...ained from 600 males and 700 females depending on geographic location gender and skeletal site For females and males Peak bone SOS was noted at age 36 45 for each skeletal site Reference curves were constructed using a moving average method with a window of 5 years around each age point Table 1 presents an example of the Radius mean SOS results by age decade for the different genders Figure 1 depi...

Page 41: ...These studies provide representative samples of Caucasian women or men for use as a reference population and for computing T scores and Z scores Age years North Am Males N North Am Females N 20 29 4081 114 83 4103 107 92 30 39 4091 118 95 4150 93 100 40 49 4115 125 93 4161 131 102 50 59 4082 141 103 4095 131 90 60 69 4050 122 92 3972 141 64 70 79 4030 128 58 3949 126 48 80 90 4048 116 33 3921 149 ...

Page 42: ...ubjects were 35 to 45 years of age Results Table 2 2 contains a summary of SOS results measured at the distal 1 3 radius in m sec for each study group All pair wise differences between the three groups were statistically sig nificant p 0 0001 Table 2 2 SOS Results by Study Group Radius Only Logistic regression for hip fracture discrimination indicates that the area under the ROC curve unadjusted f...

Page 43: ...criminate subjects with major osteoporotic fractures from non fracture subjects and to deter mine the fracture risk estimate by measuring the SOS at the dis tal 1 3 radius proximal phalanx and fifth metatarsal Methods The study was carried out by one investigator in Israel A total of 274 Caucasian women were recruited into three fracture groups hip vertebral and wrist and an elderly non fracture g...

Page 44: ... 1 93 The largest OR was found for the Metatarsal At the Radius for every 174 m sec decrease in SOS the odds of fracture increase by about 50 and for every decrease of 297 m sec in SOS the odds of fracture double Data for the other skeletal sites are also presented in Table 2 4 Hip Fracture Vertebral Fracture Wrist Fracture Non Fracture Radius N 94 N 50 N 41 N 89 SOS Mean SD 3873 154 3877 144 3880...

Page 45: ... studies were performed to eval uate various aspects of reproducibility of SOS measurements The objective of all three types of studies was to estimate the variability of in vivo SOS measurements of a human subject between device components different operators and with repeated measurements These measurements were repeated with all three types of probes CM which is used to measure the distal 1 3 r...

Page 46: ...ombination of system and probe ranged from 0 18 to 1 01 0 25 overall Reproducibility of Operators and Probes In this type of study three operators and four CM probes were evaluated Similar studies were performed using four CR and four CS probes but for simplicity will not be reported here though the results are quite similar to those obtained with the CM probes Each operator measured the distal 1 ...

Page 47: ...s measured by three different opera tors a total of 45 pairs of repeated SOS measurements are available to assess the reproducibility of repeated measure ments The overall CV for the Radius was 0 40 95 CI 0 39 to 0 41 For pre menopausal women mean age 29 4 7 6 years the Radius CV was 0 29 and for postmenopausal women mean age 57 6 5 9 years the CV was 0 57 The overall precision of the radius T sco...

Page 48: ...n DXA measurements postmenopausal CV higher than premenopausal CV as well as in QUS measurements of the calcaneus post menopausal CV lower than premenopausal CV There were also differences between CVs measured by different operators Nevertheless all CVs were well below 1 indicating precision for all subgroups and thus allowing for a meaningful assess ment of patient status relative to the referenc...

Page 49: ...e population changes detailed in Table 2 6 thus shortening the monitoring time intervals 2 8 Individualization of Treatment Omnisense measures the Speed of Sound SOS in m sec of an ultrasound wave that propagates along the bone These results may be used by the physician along with other factors such as laboratory test results radiographs life style and family history in the diagnosis of osteoporos...

Page 50: ...hin a window 5 years above and below each age point In the U S reference database this occurs at 41 years of age for the radius at 40 years of age for the metatarsal and at 36 years of age for the phalanx T and Z scores are defined below 2 T score The difference between the patient s SOS result and the peak average SOS of the young healthy Caucasian female population in units of population standar...

Page 51: ...ultiple skeletal sites pro vides the physician with choices when selecting a skeletal site that may be best for his her particular patient when one or more of the sites are either not accessible difficult to access or are not appropriate for measurements due to preexisting medical conditions or artifacts such as edema or arthritis Furthermore each skeletal site indicated for use with the Omnisense...

Page 52: ...2 20 User Guide CHAPTER 2 Essential Prescribing Information Figure 2 2 Example of a Measurement Report ...

Page 53: ...sually considered for diagnostic purposes Kanis et al 1994 The Omnisense sensitivity and categorization capability was found in various studies to be similar to those of hip and spine BMD and it is therefore suggested that the WHO criteria be adopted and applied to the Omnisense measured T scores The physician should of course consider other risk factors such as low body weight fracture history fa...

Page 54: ...d not be compared to measurements obtained from a different skeletal site at a different time 2 9 Patient Counseling Information Information for Patient Brochures are supplied with the Omnisense Bone Sonometer These brochures give a brief sum mary of the importance of bone density testing and information about the Omnisense Bone Sonometer 2 10 Conformance to Standards The Sunlight Omnisense Bone S...

Page 55: ...rketing Clearance of Diagnostic Ultrasound Systems and Transducers September 30 1997 ISO 10993 1992 Biological evaluation of medical devices ISO 10993 1 1992 Guidance on selection of tests ISO 10993 5 1993 Test for cytotoxicity in vitro methods ISO 10993 10 1994 Test for irritation and sensitization The Sunlight Omnisense Bone Sonometer meets the provi sions of the Medical Device Directive 93 42 E...

Page 56: ...ers acting as receivers housed tightly together in a compact holder Foot Pedal System Quality Verification Phantom User Guide Power supply cable Gauges for marking the region of measurement according to the skeletal site order specification Measurement accessories according to the skeletal site order specification Starter Kit see below The Omnisense 8000S packaging includes the following Main Unit...

Page 57: ... Starter Kit for both types of devices 1 acoustic contact gel bottle 250 cc CD Skin Marker Screw Driver 2 12 Operators Manual Refer to Chapters 2 through 18 for the complete directions for use and maintenance of the Omnisense Bone Sonometer 2 13 References Kanis JA Melton LJ 3rd Christiansen C Johnston CC and Khaltaev N The diagnosis of osteoporosis J Bone Miner Res 1994 Aug 9 8 1137 1141 Kanis JA...

Page 58: ...HK Heller M and Gluer C C A new method for quantitative ultra sound measurements at multiple skeletal sites J Clin Densitom etry 2000 Spring 7 1 1 7 Hans D Srivastav SK Singal C Barkmann R Njeh CF Kan torovich E Gluer C C and Genant HK Does combining the results from multiple bone sites measured by a new quantitative ultrasound device improve discrimination of hip fracture J Bone Miner Res 1999 14...

Page 59: ...ty The method is widely known in its qualitative mode for example when used to obtain in vivo views of the heart or fetus Ultrasound can also be used in a quantitative mode by measuring various parameters associ ated with the propagation of a signal through the medium of interest Quantitative ultrasound QUS is rapidly becoming accepted as a method of choice for the assessment of bone sta tus prima...

Page 60: ...devices Omnisense is distinct in its unique Omnipath Axial Transmis sion i e measurement along the bone axis 3 2 Omnisense Technology Omnipath In the frequency range used by Omnisense an ultrasound signal travels much faster through the relatively dense cortical layer of the bone than through the trabecular layer approximately 4000 m s vs 1800 m s The signal travels through soft tissue much more s...

Page 61: ... medium acts as a new transmitter thus propagating the signal again in all directions It follows that there are many paths that the signal can follow from transmitter to receiver Omnisense derives useful information from this scenario by detecting the first signal to arrive at the receiving transducer The path of this signal is determined by Snell s Law upon entering the bone the signal is refract...

Page 62: ...gnosis of osteoporosis and other medical conditions leading to reduced bone strength and ultimately in the determination of fracture risk 3 3 Relationship between Omnisense Results and Risk of Fracture Use of the OmnisenseBone Sonometer in the assessment of fracture risk is based firstly on the results of clinical studies designed specifically for Omnisense and secondly on known results for quanti...

Page 63: ...n assessment is based on SOS measurement results from multiple sites1 2 In addition patients may be assessed even when a particular site is injured or otherwise inappropriate for scanning CORRELATION WITH STRUCTURAL BONE FEATURES Traditional measures of fracture risk are based on the density of bone However it is well known that bone strength depends on a variety of factors of which density is onl...

Page 64: ...s multi site capa bility makes it possible to improve the statistical significance of results as compared with single site measurement Second it goes beyond mineral density to assess bone strength with a measure that correlates with a range of factors The two advances combined may be expected to provide a risk assess ment capability more reliable than has been available until now A SYSTEM THAT GRO...

Page 65: ...ducted when the phantom temperature is outside the range of 15 30 degrees Centigrade If for example the examina tion room temperature was below this range during the night a wait period will be required while the phantom sta bilizes to room temperature Omnisense should be positioned so that direct sunlight is avoided If the phantom is exposed to direct sunlight it may be permanently damaged Do not...

Page 66: ...he indicator is RED please note this condition on the bill of lading and call a Sunlight representative 4 2 1 Unpacking Omnisense 7000S Ensure that all components indicated on your packing list were received In some cases the items supplied may vary with your order type These are indicated Be sure to check your shipping order for special items or specifications Omnisense main unit 4 1 on page 4 5 ...

Page 67: ...ed on your packing list were received In some cases the items supplied may vary with your order type These are indicated Be sure to check your shipping order for special items or specifications Omnisense 8000S device and power supply cable Keyboard with integrated mouse One or two probes as per your order Foot pedal with connecting cable One System Quality Verification Phantom Accessories per skel...

Page 68: ... Review this material briefly to familiarize yourself with important controls ports and connectors as well the accessories used in patient measurement 4 3 1 Identifying System Components for Omnisense 7000S The next figures illustrate the Omnisense main unit front and rear panels Verify that the unit you received has connectors and features as described below ...

Page 69: ...he Omnisense main unit front view Table 4 1 Front Panel indicators and ports 1 Probes 2 Probes holder 3 ZIPTM drive slot in some models CD RW slot 4 3 5 diskette slot 5 Hard disk drive LED indicator 6 Omnisense operation LED indicatorr 7 Main power switch 1 2 3 4 5 6 7 ...

Page 70: ...lus trated in the next figure Familiarize yourself with the sockets at the back of the unit and check that they correspond to those specified below Figure 4 2 The Omnisense main unit rear view Table 4 2 Rear Panel sockets and ports 1 2 3 4 5 6 7 8 9 10 11 12 13 14 1 Probe slots 2 Type B IEC 601 1 symbol 3 USB socket 4 Network socket 5 Keyboard socket 6 Mouse socket 7 Earphone socket optional 8 Pow...

Page 71: ...ducting an SOS measurement the examiner uses a hand held probe at the area of interest applied directly to the patient s skin 9 AC power inlet 10 Printer output 11 Monitor data socket 12 COM2 not used 13 Foot pedal socket COM1 14 Additional Grounding earth connector ...

Page 72: ...entifying System Components for Omnisense 8000S The next figures illustrate the Omnisense 8000S device front side and rear panels Verify that the unit you received has con nectors and features as described below Figure 4 3 Omnisense 8000S front view ...

Page 73: ...e probes used for scanning skeletal sites and all other cables and connectors connect to sockets and ports on the rear panel see 4 2 on page 4 6 Familiarize yourself with the sockets at the back of the unit and check that they correspond to those specified below 8 3 5 diskette slot 9 CD RWTM drive slot 10 PCMCIA slot 1 2 3 ...

Page 74: ...e 4 4 Omnisense 8000 Rear Panel Sockets and Ports 1 2 3 4 5 6 7 8 9 10 1 Probe connections 2 Power switch 3 Power socket 4 Contrast and brightness adjustors 5 Network socket 6 USB ports not used 7 Keyboard Mouse socket 8 Printer output 9 Foot pedal socket COM1 10 COM 2 3 4 not used ...

Page 75: ...ed with Omnisense for use in positioning a patient s arm correctly for a SOS measurement of the distal 1 3 radius The hand rest is illustrated in the photograph below Figure 4 7 Limb positioning fixtures SOS measurements of the distal radius are taken at about the midpoint of the limb while measurements of the phalanx and metatarsal are located along the respective bones To aid in finding the corr...

Page 76: ...gure 4 8 Measuring gauges page 4 12 are the same for Omnisense 7000S and 8000S 4 5 Cable Connections The Omnisense system is designed for easy set up Once you have determined that you have all the necessary parts follow the procedure below 4 5 1 Cable Connections for Omnisense 7000S Unit Setup Procedure STEP 1 Position the Omnisense Unit Place the main Omnisense unit on the surface where it will b...

Page 77: ...insert the other end into the monitor Insert one end of the color display monitor power cable connector into the monitor power socket on the rear panel of the main unit 8 Power outlet for LCD monitor in Figure 4 2 The Omnisense main unit rear view page 4 6 and insert the other end into the mon itor The monitor receives electricity through the main unit and does not need to be con nected separately...

Page 78: ...t installation 1 All the equipment connected to Sunlight Omnisense shall be certified according to standard IEC601 1 UL2601 IEC950 or other IEC ISO standards or equivalent applica ble to the equipment 2 When Sunlight Omnisense is used together with other equipment in the patient area the equipment shall be either powered by an isolation transformer or connected via an additional protective earth t...

Page 79: ...or 110 V autoswitchable and insure that you are using an electrical outlet with either rating Ensure that the main unit power switch in the front panel is off Attach the Omnisense unit power cable to the appropriate socket on the rear panel 9 AC power inlet in 4 2 on page 4 6 Plug the other end of the cable into a standard electrical outlet Note carefully the arrangement of pins on the probe conne...

Page 80: ... panel is off 4 5 2 Cable Connections for Omnisense 8000S Unit Setup Procedure STEP 1 Position the Omnisense Unit Place the Omnisense 8000S device on the surface where it will be operated Ensure that it is within reach of a standard electrical outlet and that it is well away from any source of heat or air condi tioner Ensure also that there is room for patient and operator chairs near the unit and...

Page 81: ... 9 in the figure Important safeguards notices for printer or other peripheral equipment installation 1 All the equipment connected to Sunlight Omnisense shall be certified according to standard IEC 60601 1 UL2601 IEC950 or other IEC ISO standards or equivalent applica ble to the equipment 2 When Sunlight Omnisense is used together with other equipment in the patient area the equipment shall be eit...

Page 82: ... inserted into either of the two sockets at the back of the device Press the connector firmly into its socket Tighten the locking screws as this ensures proper electrical ground Repeat this procedure for the sec ond probe and tighten locking screws Figure 4 10 Probe slots on Omnisense 8000 STEP 4 Electrical Power Connection Ensure that the main unit power switch 2 Power switch in the rear panel 4 ...

Page 83: ...Desktop screen seen in Figure 4 11 Sunlight Desktop opening screen page 4 19 will appear Figure 4 11 Sunlight Desktop opening screen Please note that the Desktop contains icons for each of the applications available on the individual device The Sun light Omnisense Adults icon is used to enter the Omnisense Adults application the icon is seen in at the top left in the Sun light Desktop screen seen ...

Page 84: ...ou take advantage of Omnisense security features by set ting a safe password for the system administrator highest level user as well as encouraging all personnel who will use the sys tem to set passwords for themselves The procedure described below shows how to enter the system for the first time when no passwords have been set This is fol lowed immediately by the procedure for setting passwords A...

Page 85: ...rrectly If it is incorrect use the backspace key to delete and retype it correctly Press TAB to move to the Password field STEP 2 Enter the System Password In the Password field type in the password pro vided by Sunlight omni Asterisks the symbol are displayed when you type into the Password field instead of the actual password characters STEP 3 Complete Initial Access To complete the access proce...

Page 86: ...ure 4 14 Change password dialog box Enter the default Omnisense password in the top field your chosen new password in the next field and again in the last field Click OK to confirm Use the above procedure whenever a change of password is required Passwords may be changed only by the user to whom the password belongs To help you get started quickly the next section describes how Administration List...

Page 87: ...ans for whom they work Physicians can change the status of opera tors to allow them to conduct SOS measurements for their patients operators cannot change their own status Also physi cians can add other physicians or operators as users while oper ators can add only additional operators All users must enter their own passwords using Change Password as described above after being added to the User L...

Page 88: ...ly creates a new user ID that is known to the system it does not assign passwords to those users Passwords may be set or changed for any user ID only by the users themselves Initially a new user does not need a pass word to enter the system as described below 4 10 The Sunlight Desktop The Sunlight Desktop includes utilities for changing various settings on your device Any changes in Date Time Mous...

Page 89: ...ails about setting options for the Sunlight Desktop see CHAPTER 11 The Sunlight Desktop page 11 1 4 11 Setting the System Time Select Options from the Administration menu and select the Set tings tab Figure 4 16 System Options dialog box Settings screen Click on Date Time at the bottom of the dialog box and choose the Time Zone tab The Time Zone dialog box is illustrated next To view the list of a...

Page 90: ... the Date Time tab Enter the date and time in the indicated fields using the Up Down or selection arrows Click OK and the system date and time are set Figure 4 18 Figure 4 17 Time Zone screen Administration Options Settings Date Time TimeZone OK or Cancel ...

Page 91: ... system at your clinic it is recommended to set all relevant system defaults that influence both everyday work and system printouts These include the default reference database to be used definitions of height and weight measure ment units clinic information language selection regional set Administration Options Settings Date Time OK or Cancel ...

Page 92: ...he first time as follows When the unit is powered up the login dialog box seen in Figure 4 19 New user access to Omnisense page 4 28 appears Figure 4 19 New user access to Omnisense Following the initial creation of the user ID no password has yet been assigned Enter the ID in the first field and click OK Leave the password field blank Immediately upon entering the system open the List of Users sc...

Page 93: ...ications A number of additional applications are available with the Sun light device For more information contact your distributor For technical details about adding additional applications to your Sunlight device see Chapter 11 The Sunlight Desktop page 11 1 Switching between Applications If you have more than one application installed on your Omnisense device you may want to switch between appli...

Page 94: ...Guide CHAPTER 4 Initial Setup Click Administration Application and the desired application or Exit to the Sunlight Desktop through Patient Exit and choose the icon of another application to enter that application ...

Page 95: ...anagement Operations These cover all functions not directly related to SOS measurement Included are user security and management patient security and management utilities for installing and configuring printers and data storage and backup operations Management operations are not available during measurement Similarly most measurement operations may not be performed while a management function is a...

Page 96: ...ile open except when performing System Quality Verification Measurement Options Patient information is always open for the subject being scanned Viewing Measurement Data You can view measurement results after three cycles of measurement have been completed Results are shown plotted against reference ranges Choose a measurement type Choose the skeletal site Open patient file Patient History may be ...

Page 97: ...t History Print Measurement Mode To enter Measurement Mode a patient file must be open or the Measurement Type must be set to System Quality Verification Patient Utilities Import Patient Data Export Patient Data Utilities Backup Restore License Status Print Setup Scan Disk Disk Compress Database Clear Printer Queue Format Diskette System Administration List of Users Patient Management Visit Schedu...

Page 98: ... started in one of the above ways Patient Import Export and all Administration functions are not avail able During a typical work day with Omnisense the Measurement screen is continuously displayed while patient files are opened and closed Manage ment operations are used relatively infrequently Switching to Management operations To enable Management operations If a patient file is currently open C...

Page 99: ...led a Measurement Cycle The final Measure ment Result is an averaging of the results of three consistent measurement cycles 8 4 Understanding the Omnisense Measurement Screen on page 8 8 When a measurement has been suc cessfully completed the Result button becomes active and you can view the Measurement Result screen 9 1 View ing Measurement Results on page 9 1 Results can also be printed Measure ...

Page 100: ...ent measurement if a measurement is in progress save or abort the results and close the current patient file if open Three of the operations listed below are not specifically Measurement or Man agement related and are available whether or not a patient file is open These are Set Measurement Type Set Skeletal Site and Open Close Patient Enter Exit Omnisense To shut down Omnisense select Exit from t...

Page 101: ... the procedure Select Skele tal Site also a Measure ment opera tion Choose a site where SOS is to be mea sured Site selection is available whether or not a patient file is open Open Close Patient also a Measure ment opera tion Only one patient file may be open at a time A patient file must be open to conduct bone SOS measurements as well as to view or edit any data associated with that patient Too...

Page 102: ...1 An open patient file can be deleted from the patient database Show History Displays all SOS measurement results for the current patient Measurement History on page 9 11 Print Prints the patient s SOS measurement history or a Patient Schedule Report whichever is currently open Import Export This facility allows moving patient data between Omnisense systems 16 1 Import and Export of Patient Data o...

Page 103: ...t of Users This dialog box is used to add remove users set change passwords and associate operators with physicians 4 9 Adding Users on page 4 23 and 10 1 User Access Levels on page 10 1 License Status This utility enables monitoring of license type and status extending Pay Per Scan license ordering new scans and upgrading licenses These operations are performed through cus tomer support Visit Sch...

Page 104: ...age 16 20 Format Diskette Use this utility to format a diskette or disk see 16 5 Disk Utilities on page 16 15 Eject CD RW Use this menu item to eject a CD RW disk from an 8000S device if it has not ejected automatically Service Export of a log file is provided by the Omnisense device as a service tool A description of this utility is provided in 16 7 Logger on page 16 21 System Upgrade Used when y...

Page 105: ...ion Application Enables switching between the avail able applications optional Help These are found under the Help menu Help Topics The User Guide on line Measurement Methodologies Provides video demonstration of the correct measurement method for the current site Equivalent to clicking on the movie button on the toolbar Practice Mode Enable to practice measurements methodology without saving the ...

Page 106: ... Omnisense for reasons of energy conservation The procedure described below is also used when you want to reenter the system with a different user ID This is useful if for example you are transferring responsibility for SOS measure ments to an assistant and wish to limit that person s access to sensitive patient data In all of the above situations follow the procedure below Shutdown Procedure STEP...

Page 107: ...message It is now safe to turn off your computer appears turn off the system using the main power switch The second choice will cause the software to restart reboot and ask for a user ID and password if not a first time user The third option dis plays the Please Login dialog box so that you can enter the sys tem with another user name The last option exits the Omnisense application and takes you t...

Page 108: ...Omnisense 7000S 8000S 5 14 Changing Users and Shutdown ...

Page 109: ... as an hour to stabilize at room temperature For this reason SQV is specified as required once daily but need not precede all SOS measurements of the day 6 1 About System Quality Verification System Quality Verification SQV checks if the system and the probes are working properly by examining the signals returned when the phantom is used as a substitute for bone The phantom is illustrated in Figur...

Page 110: ...ed at least once daily However it is recommended that the SQV proce dure be completed as early as possible Otherwise the system warning will be displayed before every measurement The SQV procedure is conducted for each probe separately You can verify all the probes one at a time Alternatively if you know which probe you will be using you can test only that one Probes are associated with specific s...

Page 111: ...ot been connected see 3 Connect Probes on page 4 15 for 7000S or 3 Connect Probes on page 4 18 for 8000S for the correct procedure to connect probes Select the probe to be verified in the Slot selec tion box as seen in the figure The SQV procedure is described next Measurement Measurement Type SQV Measure ment Type drop down list set to System Quality Ver ification Slot selection Change Measuremen...

Page 112: ...ers to the socket on the rear panel in which the probe connector is inserted In the exam ple below 2 CM indicates that Slot 2 is selected and that a type CM probe is currently connected in that slot STEP 4 Start Measurement Mode On the Omnisense screen enter Measurement Mode by pressing the toolbar Measurement button or by clicking on the Measure menu header STEP 5 Read temperature conversion fact...

Page 113: ...obe Locate the probe and spread an even layer of ultra sound gel on its surface STEP 7 Position the phantom and probe Hold the probe in a vertical position active surface facing upwards and place the phantom directly on top of it as seen in the figure below Figure 6 3 Positioning the phantom on the probe for SQV STEP 8 Check for acoustic coupling To ensure effective coupling between the probe and ...

Page 114: ...per acoustic signal is being detected Hold the probe vertically with the phan tom set on top of it do not touch the phantom throughout the measurement Avoid any movement The signal being received may be represented by the display of a graph building on the screen from left to right as seen in Figure 6 5 If no graph build is displayed the Show Measurement Profile option has been set off To turn it ...

Page 115: ...V STEP 10 Repeat for three cycles When the graph reaches the right end of the screen the audible tone stops a distinct beep is heard and the measurement cycle is complete Completion of the measurement cycle is also indicated by the crossed flags icon as seen in Figure 6 6 To insure statistical validity of your result Omnisense requires that the measurement cycle be repeated three times The Cycle i...

Page 116: ...Figure 6 6 SQV measurement cycle completed If the Result button does not become active after three cycles this indicates that one or more of the measurement cycles yielded statistically inconsis tent results and is not usable Repeat for another measurement cycle Omnisense will allow up to five cycles if three consistent measurement cycles have not been obtained after five cycles the mea surement i...

Page 117: ...e Contact BeamMed Customer Support STEP 11 Go to Result Click on the Result button and the following is dis played Figure 6 7 Entering the expected phantom SOS value Enter the number noted in Step 5 and click OK STEP 12 Check the result The result is displayed graphically along with results from recent System Quality Verifications as illustrated in Figure 6 8 STEP 13 Print Result If desired the SQ...

Page 118: ...area either above or below the colored bands indicates a problem with the probe and it should not be used Contact Sun light customer support before attempting any SOS measurements which require that probe Remember to repeat the verification procedure for each probe you plan to use SQV Measurement Result SQV result not accept able SQV result acceptable SQV result not accept able Change Measurement ...

Page 119: ...ted a patient file is opened simply by choosing it from the Patient List as described below To create a new patient file click Patient New Alternatively click on the left most button of the toolbar Omnisense displays the Patient Information Form illustrated in Figure 7 1 This form consists of four screens which we will refer to as tabs namely Common Osteoporosis Scheduler and Clinical Info The scr...

Page 120: ...ption Red Markers Fields with a red marker preceding them are mandatory the Omnisense software will not accept registration of a patient with out them Others may be left blank if desired Patient ID Any convenient identification number for uniquely identifying patient information Social Security number is a typical use of this field You can use the ID number to search for and identify a patient CHA...

Page 121: ...t Options on page 10 6 If these default items are not what you want select Admin istration Options Defaults and change them on the System Options screen This data can still be changed for the individual patient whatever the defaults are Gender Check box to indicate gender of patient This field is essential to determine the appropriate reference database used for the patient Refer ence Database Omn...

Page 122: ... any physi cian ID for the current patient and if desired restrict access to that physician for the patient next This field is informational only and does not restrict access to other physicians or operators unless the Allow only physician to view option is checked below For more information on the different levels of user access supported by Omnisense see 10 1 User Access Levels page 10 1 Allow o...

Page 123: ...dings section of the report if you like Click on Osteoporosis to open this tab Enter the information as indicated Operator Specifies the current operator the current user ID to administer SOS measurements for the patient Note that a physician can also be an operator so any current user ID sets this field This field is informational only and does not restrict other physicians and operators unless t...

Page 124: ...t Information form fields Osteoporosis Patient New or Toolbar New Patient Osteoporosis OK or Cancel Field Description General Height Weight This item may be switched from Metric to US UK units in the System Options screen as above This data is used to calculate body weight for the Clinical Risk Factors in this screen ...

Page 125: ...sk Fac tors A series of checkboxes for the physician to check if applicable including Low trauma fractures in first degree rela tives Early menopause this will be automatically checked by the device if the inputted meno pause age is under 45 Low body weight this will be automatically checked by the device if inputted weight is under 127 lb 58 kg or if inputted height and weight yield a BMI score t...

Page 126: ...are described in CHAPTER 10 10 2 Setting System Default Options on page 10 6 Manual scheduling Although the scheduling is set auto matically for all patients according to the default values set by the user the user is free to set any desired measurement date manually using the Scheduler form in the Patient Information dialog box illustrated in Figure 7 3 Lifestyle habits A series of checkboxes for...

Page 127: ...rent date and patients scheduled measurement confir mations Figure 7 3 Patient Information dialog box Scheduler screen Table 7 3 provides further explanations on the Scheduler form fields Table 7 3 Scheduler Form fields Patient New or Toolbar New Patient Scheduler OK or Cancel Field Description Last Measure ment date Displays the last measurement date recorded for the selected patient In the case ...

Page 128: ...ing dialog box CHAPTER 10 10 2 Setting System Default Options on page 10 6 However the user can set any other desired date using the drop down lists Next Measure ment con firmed When checked selected patient is removed from the Visit Database list Exclude Patient from Sched uler list When checked patient is permanently removed from the scheduler list ignoring all scheduling default values Field De...

Page 129: ...ing a new patient to the database or editing an existing one Patient New or Edit Patient Patient Information Clinical Info The complete tab is shown in 7 4 Patient Information dialog box Clinical Info screen on page 7 11 below and its fields are further explained in 7 4 Clinical Information form fields on page 7 12 Figure 7 4 Patient Information dialog box Clinical Info screen Patient New or Edit ...

Page 130: ... The physician s phone number should be added as free text Chronic dis eases disor ders Entered in free text form when necessary This information is used for future refer ence by the physician Drugs Details the prescription drugs that the patient is currently taking Up to five drugs may be introduced in the patient s clinical information Drugs entered in the patient s data can be deleted or added ...

Page 131: ...tion Drug name The name of the drug entered by typing as text Daily Dosage The daily dosage in mg entered as a num ber Start date The date on which the patient started tak ing the drug End date The date on which the patient discontinued using the drug Com ments Any comments you deem necessary regarding that particular drug Entered as free text ...

Page 132: ...a patient file whenever required Upon creating a new patient file the patient file is opened For patients already registered there are two ways to open their patient file use whichever is convenient The starting point for either method is illustrated in Figure 7 6 Table 7 6 Opening a patient file on page 7 15 explains their use Figure 7 6 Opening a patient file Measurement Mode Single Site Measure...

Page 133: ...g that the button is now Close only Direct entry Type the first letters of the patient s family name or the complete ID number directly into the appropriate field at the top left of the Patient Information area on the screen and click the Open Patient button The system will present you with one of three possibilities If you entered an ID correctly and it is unique the patient information will be d...

Page 134: ...ind a patient quickly Sort the list by clicking on any of the column headers For example if you click on the Family Name header the list will sort by family name You can enter the patient s last name directly into the field at the bottom of the dialog box If the name exists the list will scroll directly to that name Once you have found the patient you want click on the patient s ID and the patient...

Page 135: ...will appear in the measurement report This button is enabled when opening editing a patient file After performing the next measurement previous comments will not appear 7 4 Deleting a Patient File This function enables deleting a patient from the patients data base together with his her entire clinical file To execute this function select a patient from the List of Patients and then select Delete ...

Page 136: ...ure 7 9 List of Patients with Delete button Patient List of Patients OK or Cancel Or Edit Or Delete In both cases the dialog box with the warning message shown below appears requesting you to confirm or abort the operation accordingly Figure 7 10 Delete Patient warning Patient Delete Patient Yes or No The dialog box has two buttons Yes and No and you are requested to confirm the deletion by pressi...

Page 137: ... list of all patients scheduled for the near future select the Scheduler button as illustrated in Figure 7 11 Figure 7 11 Selecting Scheduler report list When pressing the Scheduler button the Visit Database list illustrated in Figure 7 12 appears Measurement Mode Single Site Select Scheduler button Visit Database list ...

Page 138: ...be notified of their upcoming measurement Patients whose scheduled measurement date has passed by more than the default Post Due Date Period CHAPTER 10 10 2 Setting System Default Options on page 10 6 These patients records are tagged with a red icon meaning that their measurements should be urgently rescheduled The user can print the patient scheduler list by selecting the Print button A report e...

Page 139: ...Omnisense 7000S 8000S 7 21 Tracking Down a Patient s Measurements Figure 7 13 Patient Schedule Report Example Print button Visit Database List ...

Page 140: ...7 22 User Guide CHAPTER 7 Patient Files ...

Page 141: ... Optional Used to cover the probe surface in touch with the subject skin during measurement for better hygiene A new cap should be placed with every measurement according to a procedure detailed later in this chap ter Disinfec tion tow elettes Used to disinfect probes before use with each patient Towelettes approved for use with Omnisense are described in Chapter 12 Cleaning and Disinfecting Omnis...

Page 142: ...cu larly locating the site and performing the scan To ensure clar ity each of the three steps is presented below as a detailed procedure Please read the sections which follow carefully before proceeding Site Item s required Radius Radius gauge for measuring the limb to locate the scan site supplied with the relevant skeletal site kits Hand rest for positioning the arm during scanning supplied with...

Page 143: ...y Verification described in Chapter 6 System Quality Verification page 6 1 STEP 2 Identify the patient All SOS measurements must be conducted with ref erence to a specific patient known to the Omnisense software Please refer to Figure 8 1 Open the patient file for whom the SOS measure ment is to be conducted Click on the Open Patient button at the upper right of the patient information section of ...

Page 144: ...ment toolbar button or select the Mea sure menu header If you have not yet performed a System Quality Verification Omnisense will warn you with the following dialog box Figure 8 2 SQV warning dialog box Perform the SQV procedure as soon as possible Measurement Type Single Site New Patient button Select measure ment type Open patient button Site selection Close Patient ...

Page 145: ...he selection box labeled site Figure 8 1 on page 8 4 All activity now shifts to the right side of the screen until you complete the SOS measurement Site Selection list To choose the site scroll through the pop up list that appears in the box as shown in the figure at left As you click on different sites in the list notice that the large graphic at the right of the screen changes to display an anat...

Page 146: ...ize inaccuracies in your results When measuring at other skeletal sites remember to check carefully for variations in the method See Chapter 15 Site Measurement Methodologies page 15 1 Positioning the limb and finding the site STEP 1 Position the patient and the limb SOS measurement at the distal 1 3 radius has been defined by Sunlight clinical research at a precise point on the limb which facilit...

Page 147: ...ways the anatomical range of the bone In the case of the distal 1 3 radius measure from the gauge platform to the tip of the middle finger as illustrated in Fig ure 8 3 Place the gauge on the desktop and set the patient s non dominant elbow on a table with the forearm vertical and the palm open and extended vertically All parts of the arm distal to the elbow should be aligned as straight as possib...

Page 148: ...surement Screen The final part of the procedure for SOS measurement at the radius is given in the next section Before continuing to that procedure this section explains in detail the indicators which display on the Omnisense screen during the SOS measurement procedure You will need these indicators to complete measure ment of the radius If this is the first SOS measurement of the day click on the ...

Page 149: ... of three cycles To insure a statistically meaningful outcome the Omnisense software requires at least three measurement cycles These are combined through a proprietary averaging formula into a sin gle final SOS value called the measurement result Figure 8 5 Omnisense screen indicators for SOS measurement Measurement Acoustic Signal Acquisition Indi cator Traffic Light Acoustic con tact indicator ...

Page 150: ...ware provides you with continuous feedback during the measurement There are three feedback indicators on the screen the acoustic signal acquisition indicator the acoustic contact indicator and the progress bar and also an elapsed time indicator In addition to the screen indicators an audible tone is heard when both the acoustic contact and acous tic signal acquisition indicators are green To ensur...

Page 151: ...ight and the Acoustic Contact indicator must be green for SOS measurement to pro ceed correctly It is possible for the Acoustic Contact indicator to show green while the traffic light is red This means a signal is being detected but it is not adequate for meaningful interpre tation However the reverse is not pos sible Progress bar This indicator is found below the ana tomical picture of the site O...

Page 152: ...tings and click the appropriate checkbox However Sunlight recommends Cycle counter Shows you how many measurement cycles have been completed If five cycles have been attempted but the Result button at the bottom right of the screen is still greyed out you have not achieved three adequate measurement cycles Press Abort and begin again see below Indicator Function Measurement Start During an SOS mea...

Page 153: ...ssed flag icons indicating a successful measurement cycle has been completed The anatomical picture is replaced by a graph of the SOS values recorded and an audible beep is heard The right side of the screen appears as shown in Figure 8 7 Figure 8 7 Measurement cycle completed There are three buttons at the bottom of the screen which relate to starting restarting and ending a cycle as well as the ...

Page 154: ...rst cycle the button is labeled Start Before all subsequent cycles it is labeled Next Cycle Within the cycle the button is labeled Restart Clicking on the button during a cycle restarts the cycle deleting all acquired SOS values for that cycle Other cycles which have been completed remain intact NOTE The action of the foot pedal is equivalent to clicking this button and is recommended It allows yo...

Page 155: ...probe and have no bearing on bone status We now complete the procedure for measuring SOS at the distal 1 3 radius Abort Clicking on this button displays a dialog window with three options Abort Cancels the last measurement cycle Elapsed time is reset to zero and the cycle counter is reduced by one You can start the cycle again with Next Cycle or Start if you aborted the first cycle Abort all Cance...

Page 156: ...e color coded for quick identification the probe indication on the screen shows the correct probe color The CS probe is coded light green the CM probe the one used for the radius is coded violet and the CR probe is coded yellow STEP 3 Disinfect the probe attach probe cap Probes should be either disinfected before each patient use or used together with a probe cap Disinfection must be done with spe...

Page 157: ...port the lateral edge of the palm with the hand rest supplied with Omnisense 8 8 Hand rest and correct patient positioning on page 8 17 As a precautionary measure exam paper should be placed under the patient s hand covering the table and the hand rest to provide a physical barrier against possible soiling or contamination Exam paper should be discarded after every single patient measurement Do no...

Page 158: ...h a small T at the bot tom should be near the skin mark Hold the probe with both hands Fingers 1 3 of both hands grasp the probe near the base the surface applied to the scan area while fingers 4 5 palpate the limb during the scan and aid in guiding the movement of the probe correctly Only slight pres sure should be used when applying the probe to the scan area STEP 7 Execute the measurement cycle...

Page 159: ...c onds Figure 8 10 Scanning the radius To insure accurate and reproducible results note the following The edge of the probe toward the palm side should follow the marked line on the skin at all times Correct scan procedure for the radius Top row photos first from left to right 1 Scan begins with probe vertical to the positioned arm 2 Scan by moving first to the lateral direction about 70 degrees 3...

Page 160: ...robe s surface in contact with the patient s skin throughout the scan No part of the probe surface should be raised from the skin at any point during the scan During the measurement cycle concentrate on the site and correct application of the probe Avoid looking at the screen Use the audible signal to provide feedback and guide you in correct execution of the scan If probe caps are used replace th...

Page 161: ... right of the screen becomes active Each completed cycle will be indicated by an advance of the Cycle indicator at the top of the screen If you have completed five cycles and the Result button is still greyed out this means that the results of your measurement cycles have too much variability Click Abort and select Abort all from the options offered and try the cycle sequence again If the methodol...

Page 162: ...Omnisense 7000S 8000S 8 22 Measuring SOS at the Radius ...

Page 163: ...nt clicking on Result or simply pressing Enter takes you to the Measurement Result screen as illustrated in Figure 9 1 The right side of the screen is replaced by a graph On the left side of the window below Patient Information a group of statistics summarizes the result Figure 9 1 SOS measurement result screen Measurement Result Abort or Save and Close or Close Patient ...

Page 164: ...of the mean SOS value for his her age If previ ous measurements were performed on this patient they will be displayed in the graph as blue round dots The meaning of a particular SOS value requires interpretation based on clinical experience For comparison when measuring bone mineral density BMD with Dual X ray Absorptiometry DXA equipment 2 5 standard deviations below normal young adults reflects ...

Page 165: ...5 which is the WHO criteria for Osteoporo sis Under certain conditions the Z score value of a measurement can be outside the range of 2 5 For example when carrying out a measurement in a patient s distal radius in a place where a Measure Meaning T score This measure is most directly applicable to patient risk assessment The T score relates an SOS value to the scores obtained for young healthy adul...

Page 166: ...mmended to repeat the mea surement to certify the result Click OK to close the pop up box and then decide whether to proceed to measure the same bone in the contra lateral limb or carry out a new measurement of the same site Figure 9 2 Suggest to re measure pop up box Before leaving the measurement result screen you must decide what should be done with the result of the measurement Nor mally you w...

Page 167: ...ur patient your own records or for a referring physician To set up your printer see CHAPTER 15 Figure 15 6 Print Setup dialog box on page 15 14 A copy of the measurement report appears in Figure 9 8 Example of a Measurement Report page 9 12 below Button Function Abort Discards the currently displayed result A warning dialog window appears first ask ing if you are sure you wish to discard the data ...

Page 168: ...e of 18 for example as seen in the screen shown in Figure 9 4 Patient risk assessment page 9 6 indicates that the patient has an 18 risk of sustaining an osteoporotic frac ture over the next ten years Figure 9 4 Patient risk assessment To obtain the Patient Risk Assessment score click on the right hand mouse button while the cursor stands on the current mea surement result The screen seen in Figur...

Page 169: ...aracters of the text entered will appear in the measurement report This button will be enabled when opening editing a patient file After perform ing a further measurement previous comments will not appear 9 2 Deleting a Measurement Result In certain situations you may want to delete a particular mea surement result for a patient In this case you may delete a measurement result by clicking on the r...

Page 170: ... a facility for reviewing the measurement history of a given patient providing a convenient method for assessing changes over time Measurement History To open the Measurement History screen click on the Mea surement History icon found on the toolbar Each measurement result is displayed in a separate row If the list is long use the scroll bar to navigate up and down through the data A patient file ...

Page 171: ...the current patient are displayed each measurement result is on a separate row If the list is long use the scroll bar to move through the data The graph at the right plots Speed of Sound result data on the vertical axis against the dates of specific measurements on the horizontal axis The resulting curve is indicative of changes over time The thin lines below and above the reference curve represen...

Page 172: ...n the History screen Table 9 3 History screen indicators Indicator Meaning Yellow highlight bar The highlight bar always appears in the table of SOS measurement results at the lower left of the History screen When you enter the screen the most recent mea surement conducted for this patient is highlighted Blue dot Each individual measurement result is indicated on the graph by a blue dot Purple dot...

Page 173: ...on To exit the History screen click on the Close Patient button found to the right of the patient information area or select Patient Close from the menu bar 9 4 Measurement Report Use the Print icon on the toolbar to print a hard copy of the Measurement History for your use To set up your printer see CHAPTER 15 Figure 15 6 Print Setup dialog box on page 15 14 An example of the measurement report a...

Page 174: ...9 12 User Guide CHAPTER 9 Interpreting the Results of a Measurement Figure 9 8 Example of a Measurement Report ...

Page 175: ... System Administrator Physicians have access to their own patient data and the data of patients not assigned to any particular physician but not the data of other physicians Operators have access only to unassigned patient data However they may be associated with one or more phy sicians as described next Associations An operator may be associated with one or more physicians This association gives ...

Page 176: ...uses the dialog box shown below to be dis played Figure 10 2 Add user dialog box User IDs must be unique If the ID entered is the same as one which already exists in the system Omnisense will refuse to accept it as illustrated in Figure 10 3 Administration List of Users For users whose level does not permit them certain func tions e g Add or Associate these buttons are not active Current user ID a...

Page 177: ... from the Administration menu Click Change Password and fill in the fields in the Change Password box that will open Leave the Enter Old Password box blank and enter the new password in the Enter New Password box and again in the Reenter New Password box To delete a user ID click on Remove Removal may be done by Users only for their own IDs regardless of whether they are a physician or an operator...

Page 178: ...ans can limit access to their own patients is given later in this chapter CHAPTER 10 10 4 Patient Management on page 10 19 Table 10 1 System access user privilege levels Type of User Privileges Operator Operators can add other operators to the User List They can remove only their own name from the list of operators They can change their own password They can access only unassociated patient data ...

Page 179: ...erators They can change their own password System Administrator The System Administrator SA func tion is intended to insure that patient data is accessible in the event of an emergency such as absence of a patient s physician or a forgotten pass word When the system is entered with the SA user ID one can open Adminis tration Patient Management and unsecure any or all patients The data of all patie...

Page 180: ...Options select Options from the Administration menu Administration Options The form displayed has five screens or tabs namely Defaults Settings Scheduler License and Distributor Figure 10 5 shows the Defaults screen Figure 10 5 System Options dialog box Defaults screen Enter the data in each field as indicated using the tab key or the mouse to move between fields All information entered here will ...

Page 181: ...at part will appear as default and the remainder will display with blank fields This feature avoids the need to re enter information for each patient in cases where most of the patient population lives in the same area The two Code items at right from top to bottom are the telephone country code and area code respectively You may switch to other values for any individual patient Refer ence Data ba...

Page 182: ... measure ment results saved When this option is checked clicking on the Result button after a measurement will cause Omnisense to display a dialog box which asks if you are sure you want to save this result See Extending or Upgrading an Omnisense License page 10 20 for related information Physician only Causes the Physician only check box in the Patient information form to be checked by default Wh...

Page 183: ...h of SOS data which builds from left to right during a measurement cycle You can hide this graph by unchecking the option here When not active a picture of the anatomical site displays during the cycle Once the cycle completes the measure ment profile is displayed whether or not this option is checked For normal clinical work Sunlight recom mends that you leave this option unchecked The profile di...

Page 184: ... to concentrate entirely on the scan site System Quality Verification This option determines the period of his torical SOS measurement data which will display with the SQV results screen System Setup The four buttons in this area correspond to standard Windows system settings The procedure for setting Date Time is given in 4 11 Setting the System Time page 4 25 The procedure for setting Language R...

Page 185: ...between measurements The available options are 1 year 2 years or a period in months entered by the user Example If the option 1 year is selected and a measurement was per formed on December 1 2003 the system will automatically schedule the patient s next measurement to December 1 2004 one year later Note The factory default setting for all patients is one year between examina tions The user is fre...

Page 186: ...ual indication for the Reminder activation is the change of patient status on the Visit Database list 7 5 Tracking Down a Patient s Measurements page 7 19 as the patient record icon becomes yellow This happens when current date is within Reminder Period time window Example If the next examination is scheduled for 1st of April 2004 and the Reminder period is set for 2 weeks on March 15 2004 the pat...

Page 187: ... period namely how much time after the previously planned examination the sys tem would still notify the user of the date with a yellow marker After this period the icon would turn red The available options are 1 week 2 weeks or a number of days set by the user Example If an examination was sched uled for April 1 2004 and the Post Due Date Period is set to 1 week then on April 8 2004 the system wo...

Page 188: ...you have The file should be a bmp file named logo bmp with a size of 200x200 pixels with 8 or 24 bits per pixel Insert the disk and click Add your logo to report at the bottom of the box seen in Figure 10 8 System Options dialog box License screen page 10 14 The device will remind you of the requirements listed above Click OK and choose the appropriate drive in the Choose Drive window that will ap...

Page 189: ... already installed in the device simply repeat the above procedure with a new logo file The new logo will replace the previous logo The fifth screen in the options menu is the Distributor tab and it is used to introduce the distributor s information in the spaces provided namely name address phone number fax number and e mail address see Figure 10 11 ...

Page 190: ...Omnisense permits the selection of several languages for the user interface Language selection is accessed by selecting Administration Options Settings Language Regional in the Administration Menu This operation opens a two part form Language and Regional Settings Only available lan guages are shown Administration Options Distributor OK or Cancel ...

Page 191: ...ows of the Language and Regional dialog box Decimal Symbol Date Format Time For mat and Calendar type The country name and country code in the Defaults tab of the Options window will also change auto matically If the formats are not appropriate for your clinic you may change them by changing the regional settings on the right side of this screen If you would like to use the English User Interface ...

Page 192: ...nt and click OK You will now return to the Language and Regional Dialog box Click OK in this box to change the settings as requested Clicking on the OK button after any selection will cause the system to reboot and restart automatically Clicking on Cancel will close the window without changing the current settings ...

Page 193: ... ing to secured patients will be accessible only to the administer ing physician as well as any operators that have been associated with that physician For more information on setting secure sta tus for a patient in the Patient Information Form see 7 1 Patient Files page 7 1 For information on different levels of user status see 10 1 User Access Levels page 10 1 Security status set in the Patient ...

Page 194: ...cian Buttons at the right are used to secure a selected patient secure all patients in the list with a single mouse click or unsecure all patients respectively Clicking OK saves any changes clicking Cancel causes any changes made in the dialog box to be ignored Patients who have not been secured by any physician will be visible to all physicians and will be secured by the first physi cian who does...

Page 195: ...e Quality History is opened in the same way as the SOS measurement history for any patient Simply set Measurement Type to System Quality Verification and then select Show History from the toolbar or from the Patient menu The Probe Quality History screen is illustrated in Figure 10 15 The results of individual SOS measurements are listed at the left with the most recent measurement highlighted all ...

Page 196: ...set Measurement Type to Sys tem Quality Verification and then select Show History from the toolbar or from the Patient menu as above The screen seen in Figure 10 16 SQV choose probe window page 10 23 will appear Choose the desired probe and click OK to see the Probe Quality History screen Patient Show History or Toolbar History Change Measurement Type or switch to Measure ...

Page 197: ... down list contains four skeletal sites The radius which is the first site on the list appears as the default for a new SOS measurement You can arrange the sites so that they appear in a more convenient order and change the default with the Site Order dialog window Select Administration Site Order to display this dialog box ...

Page 198: ...te to highlight it and then use the arrow buttons at right to move the site to any desired position The Site drop down list will reflect the new ordering Site Order is typically most useful for managing the long site lists which can accumulate in research work Administration Site Order Cancel or OK ...

Page 199: ... Sunlight or with its authorized distributor or representative Select License Status from the Administration menu The dialog box shown below is displayed License type Description Pay per scan This license is purchased in increments of use such as 100 SOS measure ments Clicking Result at the end of the measurement is counted as a single use Measurement at multiple skeletal sites of the same person ...

Page 200: ...license you want in the New License Type drop down list 2 Click Print A form is printed which contains your order information and codes related to your specific Omnisense unit Click Exit 3 Fax the form to Sunlight or to its authorized distributor or representative 4 You will receive a fax in return with a 32 character code and in the case of a prepayment by use order the number of new use units 5 ...

Page 201: ... button Your license is now updated Figure 10 19 License Upgrade dialog box The Restore button is used by Sunlight technical personnel after a system failure to rebuild current license status information It should not be used by Sunlight customers Administration License Status Exit or Update License ...

Page 202: ...10 28 User Guide CHAPTER 10 System Administration ...

Page 203: ...ce will initially start up with Sun light Desktop as described in 4 6 Power On the System page 4 19 Previously Installed Omnisense Devices On an Omnisense device that is currently in use to run a single Omnisense application installation of the Sunlight Desktop requires a software upgrade The procedure is as follows Installing Sunlight Desktop Software Upgrade STEP 1 Begin Installation Process On ...

Page 204: ...Omnisense Diagnos tic applications for use on the Sunlight Desktop fall into two categories 1 Applications that are pre installed on the Sunlight Desktop and appear as enabled icons on the Sunlight Desktop These applications can be used without further software installa tion once the application hardware is attached to the device These icons automatically appear on the Sunlight Desktop 2 New appli...

Page 205: ...talled Applications Adding Pre installed Applications to the Sunlight Desktop STEP 1 Attach Application Hardware Attach the hardware required to operate the applica tion as indicated in the User Guide or Help File provided with the specific application STEP 2 Insert Hardware License Number For some applications the application will require that you insert the hardware license number in order to be...

Page 206: ...ases you will be asked to insert a license number to enable the software you will receive this license number from your dis tributor as part of the installation kit STEP 3 Attach Application Hardware Attach the hardware required to operate the applica tion as indicated in the User Guide provided with the specific application STEP 4 Complete Procedure The new application should now appear on the Su...

Page 207: ...ation can be carried out only if the manufacturer of the application has permitted the removal procedure through its installation package 11 3 Desktop Utilities Default Start up Options Omnisense devices on which the Sunlight Desktop is installed begin with the Sunlight Desktop screen upon start up This option may be changed so that the device begins with the Omnisense start up screen upon start u...

Page 208: ...tem will now use the chosen user interface language Regional Settings The default regional settings of the Sunlight Desktop in the United States are USA English settings Regional settings include date and time formats decimal number formats cur rency and currency format Changing the Regional Settings STEP 1 Change Settings To change the regional settings click Options Regional Settings Choose the ...

Page 209: ...he keyboard language currently in use If you click on the language button you will see a list of available keyboard languages To change the keyboard language choose the desired language from the list that appears This language button will appear as a scroll down button only if at least one keyboard language in addition to the default keyboard language has at some point been chosen by the process d...

Page 210: ... mouse settings by clicking on the chosen option for each of the mouse settings Click OK Date and Time Changing the Date and Time STEP 1 Change Date and Time To change the date and time click Options Date and Time Choose the appropriate date and time set tings by clicking on the chosen option for each of the date and time settings Click OK Sunlight License In the event that you would like to check...

Page 211: ...t restarts Printers To add a printer to the device click Options Add Printer and follow the instructions on the screen Please ensure that you have the printer you wish to install and the printer driver usu ally supplied on a CD with the printer If the software requests a password please use the password MP5373 Any printer added by this procedure will be available to all applications on the Sunligh...

Page 212: ...ies The Sunlight Desktop provides two disk utilities to simplify your work with the Sunlight device To eject a CD disk from the device click Tools Eject To format a 3 1 2 inch or CD disk click Tools Format and follow the instructions on the screen ...

Page 213: ...In case of using probe caps disinfection is not required Protective gloves are recommended for cleaning and disinfect ing procedures Soiled materials should be disposed of in appropriate waste receptacles The Omnisense Device 7000S and 8000S CLEANING Cleaning should be done with the probes connected to make sure that no liquid gets into the probe sockets No disinfection is required for the Omnisen...

Page 214: ... The patient contact surface of the probe should be cleaned immediately after use For cleaning it is not necessary to dis connect the probe from the Omnisense unit The following steps should be followed for cleaning the probe 1 If a probe cap was used remove and dispose it before clean ing 2 To clean the probe of any acoustic gel or residues use only dry soft tissues or towels If required use towe...

Page 215: ...ction towelette is used Towelettes appropriate for use with Omnisense probes include the Sporicidin Disinfectant Towelettes which may be purchased from EDL Inc Danville VA USA Tel Number 1 800 342 5335 or Henkel Towelettes which may be purchased from Henkel Ecolab Dusseldorf Ger many Tel Number 49 211 98930 2 Thoroughly wet surface with towelette Ensure surface remains for a 10 minute contact time...

Page 216: ...Omnisense 7000S 8000S 12 4 Cleaning and Disinfection ...

Page 217: ... on the front panel is in the On position Check the control unit fuses to make sure they are not dam aged or burned If necessary replace the fuses The operation power indicator is illumi nated but the screen is dark for Omnisense 7000S only Ensure that the monitor s power cable is correctly plugged in to the monitor and to the main Omnisense unit at the back panel LCD or to the isolation transform...

Page 218: ...Abort and restart the measure ment if necessary The Acoustic Contact Indicator shows green but the Acous tic Signal Acquisition Indicator remains red Validate the system by executing the System Quality Verification procedure Check that the probe is properly positioned for the specific site being measured If the patient s soft tissue is extremely thick at the site mea surement may be obstructed In ...

Page 219: ... be those specified by the manufac turer 14 2 Technical Specifications 14 2 1 Technical Specification for 7000S Table 14 1 Omnisense specifications Parameter Specification Measurement Speed of Sound SOS Technology Ultrasound Omnipath Axial Trans mission Probes Proprietary multi transducer probe family Center frequency 1 25 MHz Measurement Precision Accu racy RMS CV 0 4 to 0 8 in vivo precision dep...

Page 220: ...ations IEC 601 1 IEC 601 1 2 Class B UL 2601 Part 15 of the FCC rules Class B Certifications CE 0344 Mark Specifications IEC 601 1 Class 1 Type B IPX0 The UL classification for Omnisense is Class 1 Equipment Power 100 240VAC Autoswitchable 50Hz to 60Hz Power Consump tion Approx 85 VA Operating envi ronment Temperature 10o to 35o C 50 95º F Humidity 30 to 75 non con densing Storage and trans portat...

Page 221: ... Printers Standard PC printers Recommended printer list appears on the Sunlight website at http www sunlightmedical com Interna tional html printers html Additional printers may be added with the Add Printer utility on the Sunlight Desktop see Printers on page 11 9 Backup Platforms CD RW drive approx 580 MB depending on model 3 5 drive 1 44 MB Parameter Specification Parameter Specification Measur...

Page 222: ...al site User Interface Convenient keyboard and integrated mouse Calibration Calibration free Daily System Quality Verification procedure with phantom is recommended Display 12 1 TFT color LCD display Regulations IEC 60601 1 IEC 60601 1 2 Class B UL 2601 Part 15 of the FCC rules Class B Certifications CE 0344 Mark Specifications IEC 601 1 Class 1 Type B IPX0 The UL classification for Omnisense is C...

Page 223: ...ates uses and can radiate radio frequency energy and if not installed and used in Operating envi ronment Temperature 50 95º F 10o to 35o C Humidity 30 to 75 non con densing Storage and transportation conditions Temperature 0o to 50o C 32 122º F Humidity 10 to 90 non con densing Dimensions W H D 14 8 x 11 2 x 5 4 37 5 cm x 28 5 cm x 13 6 cm Weight Approximately 13 lb 6 kg Printers Standard PC print...

Page 224: ...ference to radio or televi sion reception which can be determined by turning the equip ment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is c...

Page 225: ...ite drop down list and click on the Measurement Methodology button to view a video of the cor rect measurement method for that site Please note that in the event of any inconsistency between a video and the User Guide the User Guide should be considered authoritative The Practice Mode is accessed through the Help menu for fur ther explanations on this utility and its operating mode see 15 4 Practi...

Page 226: ...ure the phalanx as described below The gauge is illustrated in Figure 15 1 Figure 15 1 L gauge for measuring the phalanx Bend the patient s third finger so that the medial phalanx is at right angles to the proximal phalanx Fit the gauge to the patient s finger so that the right angle of the gauge fits over the right angle made by the medial and proximal phalanges The shorter leg of the gauge shoul...

Page 227: ... marker Ensure that the proximal phalanx joint is behind the mark Continue drawing the mark around the finger to one half the circum ference of the phalanx i e the entire dorsal side Figure 15 3 Marking the scan position 4 Position the patient s hand face down on the desk i e the palmar side is to the desk surface The fingers should be relaxed and not stretched or rigid The shorter leg of the L ga...

Page 228: ...tes that have been approved for use with Omnisense Follow the instructions provided by the manufac turer of the towelettes If a probe cap is used the following procedure should be performed 1 Apply ultrasound gel to the probe surface 2 Mount the probe cap and make sure the cap s front skin is in good contact with the ultrasound gel and no air bubbles show 3 Another layer of ultrasound gel should b...

Page 229: ...t on the skin and the remainder of the probe s surface extends distally toward the medial phalanx Use the fingers 4 5 to palpate the limb during the scan and aid in guiding the movement of the probe correctly Figure 15 6 Correct position of the probe for scanning 10 Press the foot pedal to begin the measurement cycle When the probe is in proper contact with the area to be scanned an audible signal...

Page 230: ...o the bone while its long dimension is parallel to the bone axis Do not use a circular motion The probe movement should follow parallel to the marked line Scan approximately 180 degrees but no further Check to ensure that a scan movement through 180 degrees takes about 4 5 seconds The scan is being conducted too slowly or too quickly if the movement takes longer or shorter respectively than this a...

Page 231: ...e scan Repeat the entire procedure of the measurement cycle three times or until the Result button becomes active For informa tion on repeating a cycle see 8 4 Measurement cycle start end buttons on page 8 14 15 3 Metatarsal V Always measure the patient s non dominant side In case of a disorder or impairment in the non dominant limb such as an edema or mass use the contra lateral side instead Posi...

Page 232: ...9 Patient position prior to marking the ROI Figure 15 10 Marking the distal end of metatarsal V 3 With a skin marker place a dot just proximal to the promi nence The dot coincides with the distal end of the metatar sal shaft 4 The L gauge supplied with the metatarsal site kit is illus trated in Figure 15 11 Note that the same L gauge is used with the proximal phalanx The toes are flexed downward a...

Page 233: ...igned with the dot marked earlier The two lines drawn will be referred to as the long mark and the short mark Figure 15 12 illustrates the marking procedure Figure 15 12 Marking the scan region with the L gauge Measuring SOS at the Metatarsal V 5 Adjust the patient s position so that the Achilles ligament is supported by the leg rest as close to the operator as possible 6 Use the CR probe for meas...

Page 234: ...otos in 15 13 Scanning the metatarsal V on page 15 11 Apply a uniform layer of ultrasound gel to the CR probe and on the area to be scanned The area to be scanned is a rectangular region whose length follows the long mark and whose width extends one to two centimeters in the dorsal direction 9 Place the probe parallel to the bone the probe s long axis is aligned and centered with the long mark and...

Page 235: ... an angle to the surface of the limb The probe should be held so that the short dimension of its surface is tangent to the bone while its long dimension is parallel to the bone axis Do not use a circular motion The probe movement should follow parallel to the marked line Probe movement should extend at least 1 centimeter but not more than 2 centimeters dorsal to the long marked line Maintain the p...

Page 236: ... see 8 4 Measurement cycle start end buttons on page 8 14 15 4 Practice Mode The purpose of this feature is to allow the user to practice the specified bone measurement methodology and receive feed back on his her performance and measurement precision The Practice Mode is accessed from the Help menu Help Practice Mode When this feature is operated the soft ware header changes to Sunlight Omnisense...

Page 237: ...plication provides the recalculated CV score The CV score is given per measurement site and the CV score is site dependent accordingly CV score is a function of the Standard Deviation and your aver age measurements values Your CV score should fall in the range stated in the column labeled Good in Table 14 1 for each skeletal site before you start measuring patients Table 15 1 CV scores The user ca...

Page 238: ... measurement results graph and the T and Z scores are not available Resetting your CV scores If you wish to see your improvement over time you should reset the CV score after several trials and begin again Other wise the system will keep averaging your previous bad scores against the new ones lowering your overall score Reset ting your CV scores is done by exiting the practice mode and re entering...

Page 239: ...inical patient information and other utilities The utilities Backup Format Diskette and License Status are available at all times All other facilities described in this chapter are not available while a patient file is open 16 1 Import and Export of Patient Data At times you may wish to send a patient file to another clinic or to a hospital or receive a patient file from outside sources Omnisense ...

Page 240: ...sert the disk containing your patient information into the selected drive STEP 3 Specify Import parameters The Import facility is selective i e you choose which patient data are to be imported First select the drive in which you have inserted the patient data information disk created with Export see next Click on the Read button The patient databases available are shown in the leftmost window indi...

Page 241: ... it in different ways depending on the Autoinsertion Mode setting as described in Table 16 1 A check box appears at the bottom of the Import Patient dialog box See Figure 16 1 If you have imported data from a CD RW diskette click on Eject in the Administration menu to eject the diskette Table 16 1 Autoinsert policy for Import In this situation Import does this Import is using data exported by the ...

Page 242: ...played Import is using data exported by a different device With Autoinsert unchecked Import will stop at every patient ID found identical to an existing one and display a warning You will be asked to provide a different ID for the imported patient With Autoinsert checked Import appends the number 1 to the IDs of patients found with ID identical to one in the system thus distinguishing them No warn...

Page 243: ... of the window STEP 3 Specify the patient data to be exported Click successively on the lines in the center window to select multiple records If you change your mind about a selection you can unselect by clicking over a selection or start over by clicking Unselect All Use Select All if you want to export the entire data base Checking Use Security will cause security informa tion to be transferred ...

Page 244: ...ptional formats Measurements by Site Each line in the file represents one measurement Measurements by Patient Each line in the file represents the last measurement of a patient in three measurement sites Radius Metatarsal and Phalanx Measurements by Site is more suitable for site development precision studies or longitudinal follow up while Measurement by Patient is more suitable for clinical cros...

Page 245: ...will not appear except for the latest measurement on each date The file contains the following list of columns in the following order Column head ings titles are printed at the first line Empty fields are marked N A 1 PATCODE Patient ID 2 VISITDA Measurement Date according to regional set tings e g DD MM YY 3 BIRTHDA Date of Birth according to regional settings e g DD MM YY 4 SEX Gender 5 HEIGHT H...

Page 246: ...urement Date according to regional set tings e g DD MM YY 3 BIRTHDA Date of Birth according to regional settings e g DD MM YY 4 SEX Gender 5 HEIGHT Height cm 6 WEIGHT Weight kg 7 10 SOS Max SOS R T M P 11 14 T SCORE T Score R T M P 15 18 Z SCORE Z Score R T M P 19 REFERENCE Ref database 20 MPAge Menopause Age 21 FRACTURE Fracture History Hip Spine Wrist 22 26 MEDICATIONS Medication first five 27 B...

Page 247: ...rt restoration of data lost in the event of fire disk failure loss of a data volume or other undesir able event Regular backups reduce the probability of data loss due to events of this kind A Restore operation replaces the entire user database on Omnisense including patients patient measurement results users and System options The Backup Restore facility is not intended for use as a mecha nism to...

Page 248: ...1 Open the Backup dialog box Select Backup from the Administration menu The following dialog box is displayed Figure 16 4 Backup dialog box STEP 2 Set parameters Enter information as indicated The table below explains the meaning of each field Administration Backup OK or Cancel ...

Page 249: ...f you should need to restore a system find the Backup with the date required usually the most recent one and perform the procedure described next Field Meaning Last backup The date of the most recent Backup oper ation Drive Select the drive into which the backup will be written You must insert media with enough free space in the selected drive A 3 5 inch diskette can hold about 1 4 MB a ZipTM disk...

Page 250: ...6 5 Restore dialog box STEP 2 Check that you have the correct Backup There are no parameters to set in the Restore dialog box The entire system is simply replaced with the one from the Backup disk The fields in the dialog box are informational they give important dates by which you can determine if you should execute the Restore as described in the table below Administration Backup OK or Cancel ...

Page 251: ...mber of parameters which will apply when printing such as paper size and orientation Normally you set these once and they apply automatically for all printing You need to reset them only in case of significant changes such as a new printer or change in your standard paper size First open Print Setup from the Administration menu The Print Setup dialog box is displayed Screen Item Function Date of D...

Page 252: ...ee Printers page 11 9 Consult your system administrator to set up the addi tion of a network printer Administration Print Setup OK or Cancel Field Purpose Printer Name Select the printer to be used from the drop down list Paper Size Specify the size of paper you will be using Two sizes are supported interna tional A4 29 7 x 21 cm and US letter 8 5 x 11 inches Orienta tion This option should be set...

Page 253: ... file problems and in case of bad sectors will map the disk directory so as to avoid using them Although corrupted data on hard disks is rare it does happen and regular application of Scan Disk will lower the probability of data loss To run Scan Disk choose Administration Repair Tools Scan Disk The following dialog box is displayed Figure 16 7 Scan Disk dialog box Enter information in the dialog b...

Page 254: ...inconvenient Heavily fragmented files are also more subject to corruption Use the defragmentation facility at regular intervals to keep your software performing as it should Select Administration Repair Tools Disk Compress The Disk Compress dialog box is displayed Field How to enter Select Drive Choose which drive is to be scanned Scan disk may also be used to check the integrity of removable medi...

Page 255: ...he Disk Defragmenter window to close the window and return to the Omnisense screen Format Disk Additional CD RW disks that you may have purchased outside of Sunlight are always un formatted and require formatting for use The formatting procedure described below is used both for the CD RW disk supplied with the Administration Repair Tools Disk Compress Analyze or Defragment or File Exit ...

Page 256: ...side of the device Select Format Diskette from the Administration menu 2 Choose Capacity Format Type and other options if desired Click Start and the formatting process will begin 3 A message box will indicate to you that the format is in progress When the format is complete another message box will inform you that the diskette is ready Figure 16 9 Format Diskette dialog box Administration Format ...

Page 257: ...ith a message as follows Direct CD is about to format the CD in Drive E It will take approximately 25 45 minutes for processing proceed now 5 Click OK and the formatting process will begin A message box will indicate to you that the format is in progress When the format is complete another message box will inform you that the CD is ready Click OK and the CD will eject 6 The CD is now formatted and...

Page 258: ...repair will then proceed automatically When it is complete restart your computer to use the database as usual Clear Printer Queue The Clear Printer Queue utility is available for situations in which an operator has inadvertently sent a print job to a printer that is not functioning or not available with the device To clear the printer log of printing jobs that cannot be completed click Administrat...

Page 259: ...f the failure is user maintainable the message instructs the user on the procedure required to overcome the failure If the failure is of a type that can be remedied by obtaining remote instructions by phone the message will advise the user to print an encrypted report and send it to the local regional Support Center by fax or e mail and then await further instructions If the failure requires the p...

Page 260: ...o the system with a simple software upgrade You need only add the appropriate skeletal site kit which may include a probe measurement accessories for pre cisely locating the site and fixtures to position the limb during SOS measurement Software upgrades may also be used to extend or add reference databases and for the installation of new features System Upgrade is found under the Administration me...

Page 261: ...ation Site Upgrade Select Administration System Upgrade and the following dia log box will appear Figure 16 11 System Upgrade initial dialog box Omnisense will determine the type of upgrade directly from the media you insert in the drive In the case of a Site Upgrade disk the following dialog box will appear next Administration System Upgrade OK or Cancel ...

Page 262: ...mn All sites appearing in the right column will be added or updated when you click OK Use the same procedure for databases Each site has three components Site parameters including the reference database if avail able An instructional video illustrating the correct method for measuring SOS at the site and The site skeletal image which appears on the Omnisense screen when the site is chosen This ima...

Page 263: ...ll three of the above components are automatically written to your Omnisense disk and will be available the next time you start the system If Omnisense detects that an earlier version of the site already exists it will ask you if you want to upgrade to the new version before proceeding After upgrading a site from a CD RW diskette click on Eject in the Administration menu to eject the diskette ...

Page 264: ...Omnisense 7000S 8000S 16 26 System Upgrade ...

Page 265: ...w skeletal sites and the use of new or extended reference databases Data con version for off line analysis is also supported 17 1 The Research Mode screen Research Mode is distinguished from the Clinical version of the Omnisense screen by three additional features as illustrated in Figure 17 1 Figure 17 1 Omnisense Research Mode screen Default in Research Mode Research Menu Research information Pr...

Page 266: ... also provided with the Research version These are referred to as System Sites Additional sites created by researchers for their own work are called User Sites Modifica tions to sites are supported only for User Sites An attempt to modify a system site will be denied The menu options provided are as follows Edit Site modify the parameters of a user skeletal site Copy site used for creating a new u...

Page 267: ...w skeletal site for measuring SOS with Omnisense first set the Site Selection window to a system site that is closest to the type of site you want to define You can choose an arbitrary site however you can avoid entering some of the parameters if you know of a site that is similar to what you want Select Copy Site from the Research menu The Site definition screen is displayed Research Information ...

Page 268: ...17 4 User Guide CHAPTER 17 Research Mode Figure 17 2 Edit site dialog box Enter parameters as required The field functions are detailed in the table below Research Copy Site Cancel or OK ...

Page 269: ...r the site is selected on the main screen Site name Upon copying a site a new name is automati cally created the original system site name with N appended to distinguish it as a User site You can change the name to anything you wish simply type the new name in the Site Name field The chosen name will appear in the Site Selection drop down list Probe type Enter the probe type to be used for this si...

Page 270: ...s and allows as many as five It computes a final result as the average of three cycles have been found suffi ciently consistent See 8 4 Understanding the Omnisense Measurement Screen on page 8 8 for more information Min Max SOS Specifies the maximum range of variation per mitted for the SOS signal at this site Outside this range SOS will not be recorded and the Acoustic Signal Acquisition indicato...

Page 271: ... Research version of Omnisense the Options item under the Administration menu provides an additional tab labelled Advanced This dialog box allows you to set a number of parameters relating to the type of data that are saved from SOS measurements Note that this data consumes hard disk space Maxi mum tilt angle If the angle at which the probe is applied to the site exceeds that specified here Omnise...

Page 272: ...stration Options Advanced Cancel or OK Dialog item Description Save Velo city Causes each sample SOS point of a measurement to be saved Normally only the final result is saved Save Depth For each point of the measurement the average soft tissue depth is saved Save Time Scale Saves the elapsed time at each point of the measurement This allows assess ment of operator pauses which interrupt the scan ...

Page 273: ...ata and compile the results so that you have a sin gle reference SOS value for each age range gender and popula tion type of interest You then enter this data using the Reference DB Builder dialog box as described below Save Traces Traces are three streams of raw data corresponding to SOS signal times from which other parameters of a scan are calculated With this option the trace data are saved Hi...

Page 274: ...e 17 4 Table 17 4 Reference Database Builder fields Research Reference DB Cancel or Edit Screen feature Function Site Select the site for which the reference data were obtained Gender Enter the sex of the population from which the reference data were obtained Refe rence DB Enter a characterization of the population from which the reference data were obtained ...

Page 275: ...fer ence SOS value applies Altogether there may be up to 50 values entered for each reference database Step Enter the number of years above the value entered in the Age field for which the reference SOS value applies These are steps of identical size such as decades Finger button First click on this button activates the Age and Step fields so you can enter reference data If you click on this butto...

Page 276: ...but tons Use the arrow buttons to move to the next reference value and SD Norm Enter the reference SOS value SD Enter the standard deviation from the value entered in Norm OK Edit After entering the data for a new data base click OK this saves the data entered The button changes to Edit allowing you to make corrections to the data just saved with OK See text below for detail on entering data in th...

Page 277: ...dvances by the amount of the Step field and you enter Norm and SD values for that age range With the next click of the right arrow you move on to the next age range After entering Norm and SD for the last age range click OK If you mistakenly clicked on the right arrow button after the last entry the OK button becomes greyed out Click on the left arrow button to return to the previous entry then cl...

Page 278: ...17 14 User Guide CHAPTER 17 Research Mode ...

Page 279: ...ll the necessary functions with the keyboard only 18 1 How to Use Help Table 18 1 Using Help Function Keys Start Help F1 Move between topics See Table 18 6 Moving between list dialog box items fields page 18 5 Move between tabs See Table 18 6 Moving between list dialog box items fields page 18 5 Move among the jumps in a topic ARROW keys Choose a subject and enter it ENTER or SPACE BAR Quit Help A...

Page 280: ...nction Description Select a list item or check box SPACEBAR Change a patient s status to Secure Patient Manage ment List ALT S Change a patient s status to Unsecure Patient Man agement List ALT U Secure all patients on a list Patient Management List ALT A Choose a patient from Patient List Type first characters of the family name and press SPACEBAR for selection ...

Page 281: ...or F10 if a menu is open press ESC twice Select a menu ALT the underlined Character in the menu name Choose a menu command An ARROW key ENTER or the under lined character in a command name Note although you can choose any menu com mand by using this method many com mands have faster key board equivalents which are usually shown next to the command on the menu ...

Page 282: ... items fields page 18 5 Carry out command Press ENTER Choose a selected item SPACEBAR Move around and select items in a list See Table 18 6 Mov ing between list dia log box items fields page 18 5 and Table 18 2 Dialog box selection incl Patient List and Patient Man agement list page 18 2 Cancel the dialog box Press ESC or ALT F4 confirmation dialog boxes cannot be can celed by using these keys ...

Page 283: ...haracter to the left or right or delete selected text BACKSPACE or DEL Copy selected text onto the clipboard CTRL C or CTRL INS Paste text from the clip board CTRL V or SHIFT INS Undo the last editing action CTRL Z or ALT BACKSPACE Function Keys Between menu commands characters in a text box or items in a list An ARROW key To the next or previous dia log box item to the next or previous field on t...

Page 284: ...een fields Up Down ARROW keys To a dialog box item ALT the character underlined in the item name Right or left one word in a text box CTRL an ARROW key To the beginning or end of a line list or screen HOME or END Between tabs in the same dialog box Right Left ARROW keys Function Keys ...

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