BeamMed Sunlight Omnisense 8000S, Sunlight Omnisense 7000S User Manual

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Sunlight

Omnisense

7000S/8000S

Bone Sonometer

User Guide

U.S. Software Version 2.2

DUM 0049 Revision 02

0344

Note: The information in this document is confidential and proprietary. It is provided to customers and authorized representatives of BeamMed Ltd.

ight Omnisense

Sunl

7000S/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

8 Halapid

Ltd.

Street

P.O. Box 7520

Petach-Tikva, 49170

Israel

Tel. +972 (3) 9236869

Fax. +972 (3) 9236867

Contact Information

Customer satisfaction is a BeamMed priority. To help us in providing you with the best possible product and support, please send us your comments and suggestions. Contact us at the addresses and telephone numbers below:

BeamMed Ltd. 8 Halapid Street P.O. Box 7520 Petah Tikva 49170, Israel

Tel : +972 (3) 9236869

Fax: +972(3)

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

9236867

iii

SOFTWARE LICENSE, WARRANTY AND LIMITATION OF LIABILITY

(Sunlight Omnisense® 7000S/8000S)

The terms of the Software License, Product Warranty and Limitation of Liability specified below are an essential part of your agreement with

BeamMed Ltd.By using any BeamMed equipment and/orsoftware described

in this manual, you agree to be bound by theseterms. If you do not agree to these terms, you must contact your BeamMed representative within five days of receipt and we will arrange to enter into a written agreement, or for your return of the equipment and software.

Software License

All software (hereinafter, the Software) is supplied under this license only. BeamMed retains all title to and all copyrights to the Software and any copies thereof.

Purchaser is granted a non-exclusive, royalty-free license to use the Software solely on the equipment on which it is installed at time of delivery (or on the equipment for which it is intended to be installed, if not installed when delivered), 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 provided to use the Software for Multi-Site quality control or data review purposes. Purchaser must maintain all copyright, proprietary or other notices on the Software, must not decompile, disassemble or reverse engineer the Software and must not make it available to any party except those using the Software as part of their duties.

Limitation of Liability

In no event shall BeamMed be liable for any direct, indirect, special, incidental or consequential losses, damages or expenses whether based on contract, tort, or any other legal theory and whether or not advised of the possibility of such damages.

Manufacturer's Warranty

Thank you for purchasing this BeamMed Ltd. Product. Please fill out the attached warranty card, photocopy it, and fax it to (Israel)

+972 (3) 9236867 within 30 days of your date of purchase.

BeamMed Ltd.

UNLIGHT OMNISENSE

EXCLUSIVE AND LIMITED ONE YEAR WARRANTY

A Warranty Coverage

The products covered by this warranty are the following: (i) Sunlight Omnisense (ii) Ultrasonic Probes (hereinafter the Product, or Products).

Products manufactured by BeamMed Ltd. ("the Company") are covered by a warranty against defects in materials or workmanship. If the Company receives notice of such defects during the warranty period, 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 be subject to this warranty for the remaining of the warranty period or

7000S/8000S UNIT/ULTRASONIC PROBES

7000S/8000S System Unit, and

30 days, whichever is later.

This warranty is valid in any country in which the Company's Products are distributed by the Company or its authorized distributor.

B Duration and Commencement of Warranty Period

1. The warranty period for each Product is one year. The warranty

period begins on the date the Product was purchased, provided that the Company receives this warranty card within 30 days of purchase.

C Limitation of Warranty

1. The Company does not warrant that the operation of Products will

be uninterrupted or error-free.

2. The foregoing warranty applies only to defects resulting from nor-

mal use of the Products within the country in which it was purchased, and does not apply to defects resulting from:

(a) Improper or inadequate maintenance;

(b)Use of any parts or software not supplied by the Company;

(c)Unauthorized 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 otherwise, including, but not limited to, any implied warranty of merchantability or fitness for a particular purpose. The remedies herein contained are the sole and exclusive remedies of the customer.

4. This warranty gives the customer specific legal rights, but appli-

cable local laws may provide additional legal rights or prohibit certain terms or conditions of this warranty. Any provision of this warranty that is prohibited by local law is therefore null and void.

vii

D Warranty Card

Purchaser’s Name ______________________________________

Purchaser’s Address_____________________________________ ______________________________________________________

Distributor’s Name and Address____________________________ ______________________________________________________

Sunlight Omnisense

7000S/8000S

Model _________ Serial Number _______

Ultrasound Probe(s): Type _____ Serial Number _____________

Type _____ Serial Number _____________

Date of Purchase_________ Name___________________

Signature________________

viii

END USER LICENSE AGREEMENT

The Distributor shall be entitled to provide separate and additional warranty terms respecting the Product, but shall not be authorized to bind BeamMed to such additional terms and shall indemnify BeamMed against any such liability.

The Distributor’s standard End User License Agreement will include the following provisions:

1. Purchase of the Product shall entitle the End User to a personal,

non-transferable, non-assignable, non-exclusive and limited rights to use the software component of the Product (the "License", and the "Software" respectively).

2. The Product is licensed as a single product. The End User may not

separate its component parts for use as more than one system or for any other purpose.

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 sale of the Software or any portion or copy of it. A copy of the Software is provided to the End User only to allow the End User to exercise its rights under the License. The Hardware component of the Product is purchased by and the Software is licensed to the End User for the End User's internal use and the Product may not be used by, sub-licensed, re-sold, rented, or distributed to any other party. The End User may not assign the End User's rights under this Agreement without the prior written consent of the Distributor.

(b)The End User acknowledges that the source code of the Software,

and the concepts and ideas incorporated by this Product, are valuable intellectual property of the Distributor's supplier and/or licensor. The End User agrees not to copy the Product, nor to distribute any such concepts or ideas to any third party, or to attempt (or permit others) to decipher, reverse translate, de-compile, disassemble or create derivative works based on the Product or any part thereof, or to develop methods to enable unauthorized parties to use the Product, or to develop any other product containing any of the concepts and ideas contained in the Product. Trademarks may be used only to identify printed output produced by the Product. The provisions of this paragraph shall survive the termination of this Agreement.

(c)The Distributor and/or its supplier and/or licensor shall have the

right, but not the obligation, to defend or settle, at their discretion, any legal action against the End User arising from a claim that the End User's permitted use of the Product under this Agreement infringes any patent, copyright, or other ownership rights of a third party. The End User agrees to provide the Distributor written notice of any such claim within ten (10) days of the End User's notice thereof and provide reasonable assistance in its defense. The Distributor and its supplier and/or licensor have sole discretion and control over such defense and all negotiations for a settlement or compromise, unless they decline to defend or settle, in which case the End User is free to pursue any alternative the End User may have.

4. No Warranty. THE DISTRIBUTOR’S SUPPLIER AND/OR

LICENSOR DOES NOT WARRANT ANY WARRANTY OF ANY KIND TO END-USER.

5. No Liability for Consequential Damages. TO THE MAXI-

MUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL THE DISTRIBUTOR’S SUPPLIER AND/OR LICENSOR BE LIABLE UNDER THIS AGREEMENT, FOR ANY SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL DAMAGES WHATSOEVER, INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF BUSINESS 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 liability for consequential or incidental damages, the above limitation may not apply to the End User.

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1 Using this Guide 1-1

1-1 Outline of Contents . . . . . . . . . . . . . . . . . . . . . 1-1

1-2 Conventions Used in this Guide . . . . . . . . . . . 1-4

2 Essential Prescribing Information 2-1

2-1 Device Description . . . . . . . . . . . . . . . . . . . . . . 2-1

2-2 Intended Use/Indications. . . . . . . . . . . . . . . . . 2-4

2-3 Contraindications. . . . . . . . . . . . . . . . . . . . . . . 2-4

2-4 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 between Omnisense Results and

Risk of Fracture . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

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4 Initial Setup 4-1

4-1 Examination Room Environment . . . . . . . . . . 4-1

4-2 Unpacking Omnisense. . . . . . . . . . . . . . . . . . . 4-2

4-3 Identifying System Components. . . . . . . . . . . 4-4

4-4 Measurement Accessories . . . . . . . . . . . . . . 4-11

4-5 Cable Connections. . . . . . . . . . . . . . . . . . . . . 4-12

4-6 Power On the System. . . . . . . . . . . . . . . . . . . 4-19

4-7 Initial System Access . . . . . . . . . . . . . . . . . . . 4-19

4-8 Changing the System Password. . . . . . . . . . 4-21

4-9 Adding Users . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

4-10 The Sunlight Desktop. . . . . . . . . . . . . . . . . . . 4-24

4-11 Setting the System Time . . . . . . . . . . . . . . . . 4-25

4-12 Setting System Default Options . . . . . . . . . . 4-27

4-13 New User Entry. . . . . . . . . . . . . . . . . . . . . . . . 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 Opening a Patient File . . . . . . . . . . . . . . . . . . 7-14

7-3 Measurement Comments. . . . . . . . . . . . . . . . 7-17

7-4 Deleting a Patient File . . . . . . . . . . . . . . . . . . 7-17

7-5 Tracking Down a Patient’s Measurements. . 7-19

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8 Patient SOS Measurement 8-1

8-1 Preparing the Environment for a Patient . . . . 8-1

8-2 Readying Omnisense for an SOS Measurement .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

8-3 Locating the Measurement Site . . . . . . . . . . . 8-5

8-4 Understanding the Omnisense Measurement

Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8

8-5 Measuring SOS at the Radius . . . . . . . . . . . . 8-15

9 Interpreting the Results of a Measurement 9-1

9-1 Viewing Measurement 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.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-25

11 The Sunlight Desktop 11-1

11-1 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

11-2 Adding and Removing Applications. . . . . . . 11-2

11-3 Desktop Utilities . . . . . . . . . . . . . . . . . . . . . . . 11-5

12 Cleaning and Disinfecting Omnisense 12-1

12-1 Cleaning and Disinfection . . . . . . . . . . . . . . 12-1

13 Troubleshooting 13-1

14 System Specifications 14-1

14-1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1

14-2 Technical Specifications . . . . . . . . . . . . . . . . 14-1

14-3 Federal Communications Commission (F.C.C.)

Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-5

15 Site Measurement 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 . . . . . . . . . . . . . . . . . . . . . . 16-22

17 Research Mode 17-1

17-1 The Research Mode screen. . . . . . . . . . . . . . 17-1

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17-2 Working with User Sites . . . . . . . . . . . . . . . . 17-3

17-3 Working 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

xvii

xviii

CHAPTER 1List of Figures

Figure 1.1 Example screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

Figure 2.1 Moving Average SOS by Age - Distal 1/3 Radius North America

Females Reference Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Figure 2.2 Example of a Measurement Report. . . . . . . . . . . . . . . . . . . . . . . . .2-20

Figure 3.1 The Omnisense probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Figure 4.1 The Omnisense main unit — front view. . . . . . . . . . . . . . . . . . . . . .4-5

Figure 4.2 The Omnisense main unit — rear view. . . . . . . . . . . . . . . . . . . . . . . 4-6

Figure 4.3 Omnisense 8000S — front view . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Figure 4.4 Omnisense 8000S — side view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Figure 4.5 Omnisense 8000S — rear view. . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10

Figure 4.6 Phantom for system quality verification . . . . . . . . . . . . . . . . . . . . .4-11

Figure 4.7 Limb positioning fixtures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Figure 4.8 Measuring gauges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Figure 4.9 Pins on a probe connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15

Figure 4.10 Probe slots on Omnisense 8000 . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18

Figure 4.11 Sunlight Desktop opening screen . . . . . . . . . . . . . . . . . . . . . . . . . .4-19

Figure 4.12 Initial login 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

Figure 5.1 Exit dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-13

Figure 6.1 Phantom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Figure 6.2 The Omnisense screen for System Quality Verification. . . . . . . . . .6-3

Figure 6.3 Positioning the phantom on the probe for SQV . . . . . . . . . . . . . . . .6-5

Figure 6.4 Visual inspection of contact between probe and phantom . . . . . . . . 6-6

Figure 6.5 Measuring the phantom SOS during SQV . . . . . . . . . . . . . . . . . . . .6-7

Figure 6.6 SQV measurement cycle completed . . . . . . . . . . . . . . . . . . . . . . . . .6-8

Figure 6.7 Entering the expected phantom SOS value. . . . . . . . . . . . . . . . . . . .6-9

Figure 6.8 SQV result screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-10

Figure 7.1 Patient Information dialog box - Common screen . . . . . . . . . . . . . .7-2

Figure 7.2 Patient Information dialog box - Osteoporosis screen . . . . . . . . . . .7-6

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Figure 7.3 Patient Information dialog box - Scheduler screen . . . . . . . . . . . . . .7-9

Figure 7.4 Patient Information dialog box - Clinical Info. screen . . . . . . . . . . 7-11

Figure 7.5 Prescription Drugs editing screen . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13

Figure 7.6 Opening a patient file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14

Figure 7.7 List of Patients. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-16

Figure 7.8 Delete Patient menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-17

Figure 7.9 List of Patients with Delete button . . . . . . . . . . . . . . . . . . . . . . . . .7-18

Figure 7.10 Delete Patient warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18

Figure 7.11 Selecting Scheduler report list . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-19

Figure 7.12 Scheduler report list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20

Figure 7.13 Patient Schedule Report Example. . . . . . . . . . . . . . . . . . . . . . . . . .7-21

Figure 8.1 Opening a patient file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4

Figure 8.2 SQV warning dialog box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

Figure 8.3 Measuring the radius. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-7

Figure 8.4 Marking the radius . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8

Figure 8.5 Omnisense screen indicators for SOS measurement. . . . . . . . . . . . .8-9

Figure 8.6 Progress bar during measurement cycle . . . . . . . . . . . . . . . . . . . . .8-12

Figure 8.7 Measurement cycle completed . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-13

Figure 8.8 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 measurement result . . . . . . . . . . . . . . 9-8

Figure 9.7 Measurement History screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-9

Figure 9.8 Example of a Measurement Report. . . . . . . . . . . . . . . . . . . . . . . . .9-12

Figure 10.1 User List dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2

Figure 10.2 Add user dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2

Figure 10.3 Duplicate name warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

Figure 10.4 Delete user ID warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4

Figure 10.5 System Options dialog box — Defaults screen. . . . . . . . . . . . . . . . 10-6

Figure 10.6 System Options dialog box — Settings screen . . . . . . . . . . . . . . . .10-9

Figure 10.7 System Options dialog box — Scheduler screen . . . . . . . . . . . . .10-11

Figure 10.8 System Options dialog box — License screen . . . . . . . . . . . . . . .10-14

Figure 10.9 Choose Drive window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-15

Figure 10.10 Logo OK window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-15

Figure 10.11 System Options dialog box — Distributor screen. . . . . . . . . . . . .10-16

Figure 10.12 Language and Regional Settings. . . . . . . . . . . . . . . . . . . . . . . . . .10-17

Figure 10.13 Fonts dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18

Figure 10.14 Patient Management dialog box . . . . . . . . . . . . . . . . . . . . . . . . . .10-20

Figure 10.15 Probe Quality History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-22

Figure 10.16 SQV choose probe window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-23

Figure 10.17 Site Order dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-24

Figure 10.18 License Status dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-26

Figure 10.19 License Upgrade dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27

Figure 15.1 L-gauge for measuring the phalanx. . . . . . . . . . . . . . . . . . . . . . . . . 15-2

Figure 15.2 Correct position of gauge for measuring the phalanx . . . . . . . . . . .15-3

Figure 15.3 Marking the scan position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15-3

Figure 15.4 Applying ultrasound gel to the scan area . . . . . . . . . . . . . . . . . . . .15-4

Figure 15.5 Grasping the patient’s finger. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15-5

Figure 15.6 Correct position of the probe for scanning . . . . . . . . . . . . . . . . . . .15-5

Figure 15.7 The range of probe movement during the scan. . . . . . . . . . . . . . . .15-6

Figure 15.8 Initial patient position for the metatarsal V. . . . . . . . . . . . . . . . . . . 15-7

Figure 15.9 Patient position 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-5

Figure 16.3 Data conversion menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-8

Figure 16.4 Backup dialog box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-10

Figure 16.5 Restore dialog box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-12

Figure 16.6 Print Setup dialog box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-14

Figure 16.7 Scan Disk dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-15

Figure 16.8 Disk Compress dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-17

Figure 16.9 Format Diskette dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-18

Figure 16.10 Export procedure — saving the logger on a diskette . . . . . . . . . .16-22

Figure 16.11 System Upgrade initial dialog box . . . . . . . . . . . . . . . . . . . . . . . .16-23

Figure 16.12 Site Update dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-24

Figure 17.1 Omnisense Research Mode screen . . . . . . . . . . . . . . . . . . . . . . . . .17-1

Figure 17.2 Edit site dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17-4

Figure 17.3 Advanced Options dialog box. . . . . . . . . . . . . . . . . . . . . . . . . . . . .17-8

Figure 17.4 Reference Database Builder dialog box . . . . . . . . . . . . . . . . . . . .17-10

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CHAPTER 1 Using this Guide

1.1 Outline of Contents

The list below gives a brief description of the contents of each chapter in this Guide. This is followed with suggestions and recommended order of reading the material for different purposes.

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-today work with Omnisense.

CHAPTER 1 Using this Guide

Chapter summaries, recommended reading order and conventions used throughout this Guide.

Omnisense 7000S/8000S 1-1

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Using this Guide

CHAPTER 2 Essential Prescribing Information

Essential prescribing information, compliance with standards.

CHAPTER 3 Introducing Sunlight Omnisense® 7000S/8000S

A brief description of quantitative ultrasound methods in general, and Omnisense technology in particular. Specific advantages of Omnisense for bone status assessment.

CHAPTER 4 Initial Setup

Unpacking, cable connections and initial access to the Omnisense software.

CHAPTER 5 Working with Omnisense

A high level overview of Omnisense functions. A useful primer and general navigational aid.

CHAPTER 6 System Quality Verification

A daily procedure to insure correct functioning of probes and validity of SOS results.

CHAPTER 7 Patient Files

This chapter describes patient files and shows how to create a new patient file and open an existing patient file.

CHAPTER 8 Patient SOS Measurement

General procedure for SOS measurement presented using the distal 1/3 radius as an example skeletal site.

CHAPTER 9 Interpreting the Results of a Measurement

Explains the SOS measurement results provided by Omnisense and their significance.

CHAPTER 10 System Administration

Covers the administration of users, user security and different access levels, patient management and security and system defaults.

CHAPTER 11 The Sunlight Desktop

1-2 User Guide

Outline of Contents

Describes the Sunlight Desktop and utilities available on the Desktop.

CHAPTER 12 Cleaning and Disinfecting Omnisense

The procedure and materials to be used for cleaning and disinfection of Omnisense.

CHAPTER 13 Troubleshooting

Potential problems and suggested solutions.

CHAPTER 14 System Specifications

Product specifications.

CHAPTER 15 Site Measurement Methodologies

This chapter describes the correct method for measuring SOS at all supported skeletal sites, and details the practice mode, which enables the user to check his or her measurement 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 software upgrade.

CHAPTER 17 Research Mode

The Sunlight Omnisense® 7000S/8000S Research version provides support for the investigation of new skeletal sites and the extension of reference databases. This chapter describes these facilities.

CHAPTER 18 Keyboard Shortcuts

Explains how to operate the system only by using the keyboard, if and when desired.

BeamMed recommends that you read the rest of this chapter

before using Omnisense. It reviews the conventions used in this

Guide — information which will make your learning about Omnisense

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Using this Guide

Chapter 2, “Essential Prescribing Information”, page 2-1, covers important information on the use of Omnisense in a clinical setting, including background on clinical studies and the relationship of Omnisense results to other methods of bone assessment.

Next, read Chapter 3, “Introducing Sunlight Omnisense 7000S/8000S” to find out about the specific advantages of your Omnisense for bone assessment.

If you are using a new Omnisense system, go through Chapter 4, “Initial Setup”.

If Omnisense is already at work in your clinic and you want to start SOS measurements immediately, you can skip directly to Chapter 7, “Patient Files”, continue with Chapter 8, “Patient SOS Measurement” and read through the following Chapter 9, “Interpreting the Results of a Measurement”. You will need to get an operator or physician ID and a password from your System Administrator to enter the Omnisense software interface.

A quick reading of Chapter 5, “Working with Omnisense”, will result in a better understanding of the overall structure of the Omnisense software.

System Quality Verification must be performed daily; this is covered in Chapter 6, “System Quality Verification”.

The remaining chapters cover information required for administrating and maintaining the system, which may be read when required. The person responsible for managing general use of the Omnisense unit should read Chapter 10, “System Administration”.

1.2 Conventions Used in this Guide

Certain conventions will be used throughout this User Guide to aid in readability. We suggest you take a moment to review the material below; you will find the Guide significantly more helpful as a result.

1-4 User Guide

Conventions Used in this Guide

Definitions

Throughout this Guide the terms Omnisense, Omnisense Sonometer and Omnisense system are equivalent and refer to the Sunlight Omnisense

Sunlight Omnisense Speed of Sound. The term SOS measurement, or simply mea- surement, will refer to the general procedure which results in an SOS value for a particular skeletal site. The SOS value obtained is called a measurement result.

The actual application of a probe to a skeletal site, and movement of the probe over the site to acquire SOS signals is called a scan. The scan movement is repeated continuously until Omnisense indicates that it has recorded an SOS value. This process is called a measurement cycle. To ensure consistency and reliability, each SOS result is obtained by averaging results from at least three measurement cycles.

7000S/8000S product.

7000S/8000S is a device for measuring

In summary, the site is scanned repeatedly to complete a measurement cycle. The examiner conducts a number of measurement cycles; each cycle yields an intermediate SOS value. The intermediate values obtained from three cycles are combined to yield the final SOS measurement result for the site.

The manner in which the scan is conducted for a specific skeletal site is called a method or methodology. This includes correct positioning of the patient and limb to be scanned, the choice of probe, the way the probe is held, the type of movement and the direction and speed of that movement.

Names

The names of screens and screen items, will be indicated throughout the text according to the following formats:

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CREENS, MENU HEADERS AND DIALOG BOXES

Screen, menu headers and dialog window names are in normal text font, capitalized.

Examples: Measurement screen; Options dialog.

FIELDS, BUTTONS, MENU ITEMS AND CHECKBOXES

These names are shown in italic sans serif font, upper case, lower case or capitalized depending on how they appear on the screen.

Examples:

Current User; Measurement.

Procedures, Notes and Warnings

Throughout this User Guide you will find Procedures - a sequence of steps that are to be performed when using a certain feature or function of the Omnisense Sonometer. Procedures begin with a Procedure heading and will be followed by numbered steps, in the following format:

This is a Procedure Heading

STEP 1 Name of first step in Procedure

Explanation of first step in Procedure.

STEP 2 Name of second step in Procedure

Explanation of second step in Procedure.

Note the icon at the left of the heading.

1-6 User Guide

Your attention will be drawn to important points with the Note icon and style, as below.

Conventions Used in this Guide

A Note to which your attention is drawn is indicated by the icon at left; rules above and below the text.

Similarly, cautionary warnings are indicated with the icon and style below.

Warning and safety information will be indicated in this style.

Screens

Snapshots of screens and dialog windows, as they appear when using the Omnisense software, are found throughout this Guide. Screens are preceded by a rule and caption header. You can find out how to enter and exit a screen by looking at the far right of the figure, just above and just below the screen respectively. The screen format is illustrated below.

This line indicates how to enter the screen

Explanations of items on the screen will appear here where required.

This line indicates how to exit the screen

Figure 1.1 Example screen

Administration>User List 

OK or Cancel

Omnisense 7000S/8000S 1-7

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The entry and exit indications are specified as a sequence of actions separated by angled brackets, as illustrated by the examples 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

1-8 User Guide

Conventions Used in this Guide

Important Symbols and Labels

A number of internationally recognized symbols are found on the Omnisense unit. These relate to safety requirements and standards and are briefly reviewed below.

Table 1.1 International Symbols on Omnisense

Symbol Meaning

Attention, consult accompanying documents.

Type B equipment symbol.

CE Mark: Indicates the Sunlight

0344

Omnisense both the European Electromagnetic Compatibility (EMC) standard and the Council Directive 93/42 EEC (MDD).

7000S/8000S complies with

Omnisense 7000S/8000S 1-9

Conventions Used in this Guide

Omnisense 7000S/8000S 1-10

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 overview of the Omnisense system and the Information for Prescribers.

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

on the order of a physician (or properly licensed

practitioner).

2.1 Device Description

The Sunlight Omnisense® 7000S/8000S (Omnisense) Ultrasound 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 wellestablished laws of physics applied to the transmission of signals 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

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Essential Prescribing Information

below. For all sites, prior to initiation of the SOS measurements, the patient's personal information is entered, using the Windows graphic user interface.

SOS Measurement of the Distal One-third Radius

: The CM probe is used to measure SOS along the distal one-third of the radius of the arm. The positioning of the distal one-third of the radius is defined as the midpoint between the elbow and the tip of the third finger. After marking the precise measurement site the operator enters measurement mode. A uniform layer of Aquasonic® Clear® Ultrasound Gel, manufactured by Parker Laboratories Inc., Fairfield NJ (hereinafter referred to as "Parker Gel") is then applied to the hand-held probe and the measurement area. The probe is positioned parallel to the bone axis and is held at the base. The probe is moved around the circumference of the radius, with its longest dimension approximately in parallel to the axis of the bone. The measurement consists of three consistent measurement cycles, each of which 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 proximal phalanx joint, continuing for one half the circumference of the phalanx (i.e., the entire dorsal side of the phalanx). After marking the precise measurement site, the operator enters the measurement mode. A uniform layer of Parker Gel is then applied to the hand-held probe and the measurement area. Using his/her non-dominant hand, the Omnisense operator then grasps the third finger by the distal and medial parts. The probe, which is in the operator's dominant hand, is applied to the proximal phalanx, with one end of the probed positioned at the skin markings and the remaining surface of the probe extending distally toward the medial phalanx. The probe is moved around the proximal phalanx, from its dorso-medial to its dorso-lateral part. The probe is held perpendicular to the bone at all times during movement and SOS measurement. The measurement

2-2 User Guide

Device Description

consists of three consistent measurement cycles, each of which is comprised of 15- 20 bone scans.

SOS Measurement of the Metatarsal V

: The CR probe is used to measure SOS along the metatarsal V of the foot. The positioning of the metatarsal V is located by having the patient flex his/ her toes downward and together so that the metarsal V is prominent. A marking is made just proximal to the prominence. This marking coincides with the distal end of the metatarsal shaft. Using the L-gauge supplied with Omnisense, the corner of the gauge is lined up with the marking made for the distal end of the metatarsal shaft so that the shorter end of the L-gauge is parallel to the toes and the longer end of the L-gauge extends along the side of the foot. Two lines are drawn on the skin parallel with the inner sides of the L-gauge. These skin markings delineate the rectangular region for SOS measurement scanning. After completing the skin markings, the operator enters the 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 for a distance of one to two centimeters in the dorsal direction and then back again to the starting point. The probe is maintained in a parallel position to the metatarsal at all times during movement and SOS measurement. The measurement consists of three consistent measurement cycles, each of which is comprised of 15-20 bone scans.

Results are expressed in meters per second (m/sec), reflecting the upper 95th percentile of the sorted SOS values. Omnisense reports the bone SOS, together with the T-score (units of standard deviations relative to population reference values of healthy young Caucasian women) and Z-score values (units of standard deviations relative to matched population reference values from the same age, gender, and ethnic group), computed using the patient's SOS value and a reference database.

Omnisense 7000S/8000S 2-3

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Essential Prescribing Information

No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device.

2.2 Intended Use/Indications

The Sunlight Omnisense® 7000S/8000S (Omnisense) Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the signal velocity of ultrasound waves (“Speed of Sound” or “SOS” in m/sec) propagating at multiple skeletal sites (i.e., the distal one-third of the radius, the proximal third phalanx, and the fifth metatarsal). SOS provides an estimate of skeletal fragility. The output is also expressed as a T-score and a Z- score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk. Multiple skeletal site testing provides 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 material and from weight bearing and non-weight bearing sites) that assists in diagnosing osteoporosis and risk of fracture.

2.3 Contraindications

2-4 User Guide

The SOS measured by Omnisense has a precision error low enough in comparison with the expected annual change in a patient's measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years).

• The Omnisense is not suitable for use in the presence of a flammable anesthetic mixture containing air, oxygen or nitrous oxide.

• The Omnisense probe should not be used on subjects with breached skin or open sores on the skin area that comes with contact with the probe.

2.4 Warnings

• Never attempt to operate the Omnisense unit if it is plugged into an outlet that does not meet all electrical code requirements.

• Make sure that there is proper grounding in the wall outlet.

• Omnisense is not suitable for use in the presence of a flam-

mable anesthetic mixture containing air, oxygen or nitrous oxide.

2.5 Precautions

Warnings

• The Omnisense probe should not be used on subjects with breached skin or open sores on the skin area that comes with contact with the probe.

• Use Omnisense only indoors, in a clean, dry environment.

• To prevent fire or electric shock, do not open or expose the

Omnisense main unit to rain or moisture.

• Do not operate or store Omnisense near a heat source or air conditioner and always store the System Quality Verification (SQV) phantom near the Omnisense main unit.

• The system is not sterile. Thus, the probe must be cleaned and disinfected before each patient session. The proper cleaning and disinfection procedure is described in Chapter 11, "Cleaning and Disinfecting Omnisense‚" page 11-1. To clean the probe of any acoustic gel or residue, use only dry, soft tissues or towels. If required, use towels that are premoistened with a mild detergent or soap. If a moistened towel is used for cleaning, allow the probe to air dry before disinfecting. Immediately after cleaning, the probe surfaces

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Essential Prescribing Information

should be disinfected using 1Sporicidin Disinfectant Towelettes by allowing the probe surface to remain in contact with the wet towelettes for 10 minutes at room temperature. Do not use sterilization methods that would expose the probe to heating, steam, pressure increase or decrease, or ethylene oxide gas.

• The Omnisense device provides no protection against the harmful ingress (entry) of liquids. Hence, when cleaning the unit, avoid applying liquid near probe connections, connector sockets and openings on the rear panel, and the disk drives. Cleaning of the device should only be performed with the probes connected, to ensure that no liquid enters the probe sockets. The device does not require disinfection. Its surface should be cleaned by wiping the surface using a soft cloth that is lightly moistened with liquid detergent or mild soap that is suitable for cleaning of electrical equipment.

• SQV phantom and probes should not be immersed in liquid

kind. Alcohol-free, dry or pre-moistened wipes may

of any 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 ammonia, acetone, hydrochloric acid, chloride bleach, etc., that can damage or destroy plastics.

2-6 User Guide

• Use Sunlight recommended and approved ultrasound coupling gels with the Omnisense Bone Sonometer to generate and maintain acoustical contact of the probe with the skin.

• Parker Aquasonic® Clear® Ultrasound Gel is for external use only.

• When applying ultrasound coupling gel, do not use a Q-tip, an examination glove treated with talc, or any other applicator that may introduce fibers or other foreign matter into the probe.

1. Sporicidin Disinfectant Towelettes may be purchased from EDL Inc., Dansville, VA, USA. Telephone number:1-800-342-5335.

Adverse Events

• Do not expose the SQV phantom and the monitor screen to direct sunlight.

• When conducting the System Quality Verification procedure, avoid touching the temperature indication strip on the phantom with the fingers, as this affects the phantom temperature reading required for correct interpretation of the procedure results.

• When conducting System Quality Verification, be sure that no air bubbles are trapped in the gel between the phantom and probe, as this affects the acoustic contact of the probe with the phantom.

• 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 3000 subjects underwent Omnisense measurement.

There are no known potential adverse effects of Omnisense on health.

2.7 Clinical Studies

A variety of clinical studies were performed involving a total of more than 3000 men and women, in order to support Omnisense’s clinical use. These studies are briefly summarized below.

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2.7.1 Reference Databases

Objective: To construct geographically representative databases of mean SOS values by age, gender, and ethnic group for the different skeletal sites. Databases were obtained for Caucasian females and males in North America.

Methods: Male and female Caucasian subjects between the ages of 20 and 90 years old were recruited from the general population. Data were collected from multiple sites at different geographic locations in North America. Participating subjects had a negative history of osteoporotic fracture or chronic conditions affecting bone metabolism, were not taking medications known to alter bone metabolism, and no female subjects had experienced premature menopause.

Results: Different reference databases were constructed from SOS measurements of the distal one-third radius, the proximal phalanx III and the metatarsal V obtained 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 depicts an example of the moving average of the SOS results as a function of age for the North American, female, distal one-third radius. For that population, the moving average SOS increases to a peak of 4158 m/sec at the age of 41, with population standard deviation of 102 m/sec, and declines thereafter. The peak mean and standard deviation results are used for generating T-scores. The largest decline, about 15 m/ sec/year, is observed around age 58, eight years past the mean age of menopause. At older ages, 65 to 90, the decline slows to about 2-5 m/sec/year. Among the North American women aged 60-90, 35% had T-scores less than -2.5 and 42% had T-scores between -2.5 and -1.0. Similar behavior was found for all other reference curves.

2-8 User Guide

Clinical Studies

Table 2.1 SOS Measurements by Age and Gender - Distal 1/3

Radius Mean ± SD, in m/sec

Age (years)

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 25

All 4071±124 557 4083±146 521

North-Am

Males

North Am

Females

Figure 2.1 Moving Average SOS by Age - Distal 1/3 Radius

North America Females Reference Database

Conclusion: These studies provide representative samples of Caucasian women or men for use as a reference population and for computing T-scores and Z-scores.

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Essential Prescribing Information

2.7.2 Cross-Sectional Study of Hip Fracture Risk

Objective: To determine the ability of Omnisense to discrimi- nate osteoporotic hip fracture subjects from age matched nonfracture subjects and young healthy subjects, and to determine the fracture risk estimate by measuring the SOS values for the distal 1/3 radius skeletal site.

Methods: The study was carried out by one investigator at two investigational sites in Israel. A total of 365 Caucasian women were recruited into three groups. Hip fracture subjects were 65 to 85 years of age and were not taking medications having a positive effect on bone metabolism. Elderly non-fracture subjects were age matched to hip fracture subjects. Young healthy subjects were 35 to 45 years of age.

Results: Table 2.2 contains a summary of SOS results measured at the distal 1/3 radius in m/sec for each study group. All pairwise differences between the three groups were statistically significant (p<0.0001).

2-10 User Guide

Table 2.2 SOS Results by Study Group (Radius Only)

Hip Fracture N=50

SOS Mean±SD 3861±149 3966±145 4165±96

T-Score <-2.5 (%) 70% 39% 1%

T-Score >-1.0 (%) 10% 24% 85%

Non-Fracture N=135

Young Healthy

N=135

Logistic regression for hip fracture discrimination indicates that the area under the ROC curve, unadjusted for age, is 0.63 (95% CI: 0.61-0.79). The fracture odds ratio, unadjusted for age, is

2.16 (95% CI: 1.46-3.19) and the age-adjusted odds ratio is

1.75 (95% CI: 1.15-2.65). For every 100 m/sec decrease in SOS the odds of fracture increase by about 50% and for every decrease of 162 m/sec in SOS the odds of fracture doubles.

Conclusions: This cross-sectional case-control based study has shown that Omnisense measurements of the distal one-third

Clinical Studies

radius can discriminate with statistical significance between osteoporotic hip fracture subjects, age-matched elderly subjects without hip fracture, and young healthy subjects. This finding is noted despite a high likelihood that there are a significant number of osteoporotic subjects in the non-fracture group.

The odds ratios found in this study can be considered fracture risk estimates, and are comparable to those of other bone assessment devices.

2.7.3 Cross-Sectional Study of Hip, Vertebral and Wrist Fracture Risk

Objective: To determine the ability of Omnisense Speed of Sound measurements to discriminate subjects with major osteoporotic fractures from non-fracture subjects, and to determine the fracture risk estimate by measuring the SOS at the distal 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 group. All subjects were 55 to 85 years of age and fracture subjects were not taking medications having a beneficial effect on bone metabolism.

Results: Table 2.3 contains a summary of SOS results for each study group, for each of the skeletal sites measured. The non fractured group and the fractured group were age matched. All of the SOS differences between the three fracture groups and the non-fracture group were statistically significant (p<0.05).

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Table 2.3 SOS Results by Study Group and Skeletal Site

Hip Fracture

Radius N=94 N=50 N=41 N=89

SOS Mean±SD 3873±154 3877±144 3880±154 3953±138

T-Score <-2.5 (%) 60% 52% 54% 46%

T-Score >-1.0 (%) 7% 8% 7% 24%

Metatarsal N=56 N=27 N=25 N=74

SOS Mean±SD 3199±217 3212±227 3257±242 3414±247

T-Score <-2.5 (%) 43% 41% 32% 15%

T-Score >-1.0 (%) 9% 15% 12% 37%

Phalanx N=81 N=42 N=31 N=85

SOS Mean±SD 3596±175 3636±149 3662±156 3739±184

T-Score <-2.5 (%) 67% 60% 48% 35%

T-Score >-1.0 (%) 4% 5% 6% 19%

Vertebral Fracture

Wrist Fracture

Non Fracture

Logistic regression for fracture discrimination indicates that the area under the ROC curve, unadjusted for age, is 0.63 (95% CI:

0.56-0.70), for the Radius, with the largest AUC value found for the Metatarsal. Table 2.4 contains the results for all skeletal sites. The fracture odds ratio for the Radius, unadjusted for age, is 1.72 (95% CI: 1.29-2.30) and the age-adjusted odds ratio is

1.43 (95% CI: 1.04-1.93). The largest OR was found for the Metatarsal. At the Radius for every 174 m/sec decrease in SOS the odds of fracture increase by about 50% and for every decrease of 297 m/sec in SOS the odds of fracture double. Data for the other skeletal sites are also presented in Table 2.4.

2-12 User Guide

Clinical Studies

Table 2.4 Logistic Regression for Predicting any

Osteoporotic Fracture, AUC (95% CI) and OR (95%CI)

AUC OR

Radius 0.63 (0.56-0.70) 1.72 (1.29-2.30) 1.43 (1.04-1.93)

Metatarsal 0.73 (0.65-0.81) 2.46 (1.67-3.61) 2.19 (1.46-3.26)

Phalanx 0.68 (0.60-0.75) 2.03 (1.48-2.80) 1.73 (1.23-2.42)

Conclusions: This case-control based study has shown that Omnisense at any of the three skeletal sites, can significantly discriminate between subjects having any of the most common osteoporotic fractures and age matched non-fracture controls. This finding is noted despite a high likelihood that there are a significant number of osteoporotic subjects in the non-fracture group.

The odds ratios found in this study for each of the skeletal site can be considered fracture risk estimates, and are comparable to those of other bone assessment devices.

2.7.4 Precision Studies

Three types of in vivo precision studies were performed to evaluate various aspects of reproducibility of SOS measurements. The objective of all three types of studies was to estimate the variability of in vivo SOS measurements of a human subject between device components, different operators and with repeated measurements. These measurements were repeated with all three types of probes: CM, which is used to measure the distal 1/3 radius, CR, which is used to measure the metatarsal V, and CS, which is used the measure the proximal phalanx III. In each study reproducibility is measured by the coefficient of variation (CV), which is the standard deviation divided by the mean. Another measure of reproducibility is the precision of the T-score (TSD), defined as the mean square error divided by the

OR (Age Adjusted)

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Essential Prescribing Information

young health SOS standard error (taken from the North America Reference Database). The TSD is calculated only for the studies of the reproducibility of repeated measurements.

Reproducibility of Instruments and Probes

In this type of study, three main units, four CM probes, and three operators were evaluated to determine the reproducibility of each. All possible combinations of each element (system unit, slot number, and probe) were tested, for a total of 36 SOS measurements of the distal 1/3 radius of a single subject (3 system units X 3 slots X 4 probes). The reproducibility (CV) of the probes, for a given combination of system and slot ranged from

0.36% to 0.90% (0.29% overall). The reproducibility of the system units, for a given combination of slot and probe, ranged from 0.21% to 1.01% (0.13% overall). The reproducibility of the slots, for a given combination of system and probe, ranged from 0.18% to 1.01% (0.25% overall).

2-14 User Guide

Reproducibility of Operators and Probes

In this type of study three operators and four CM probes were evaluated. Similar studies were performed using four CR and four CS probes, but for simplicity will not be reported here, though the results are quite similar to those obtained with the CM probes. Each operator measured the distal 1/3 radius of the subject three times with each probe. As before, all possible combinations (probe and operator) were tested, for a total of 36 measurements (3 operators X 4 probes X 3 repeats). The reproducibility of the probes, for a given combination of operator and repetition number, ranged from 0.13% to 1.04% (overall

0.52%). Combining all repetitions for a single operator into one group, the probe CV for different operators ranged from 0.60% to 0.83%. The reproducibility for the operators, for a given combination of probe and repetition number, ranged from

0.19% to 0.80% (overall 0.35%). Combining all repetitions for a single operator into one group, the probe CV for different operators ranged from 0.54% to 0.64%.

Clinical Studies

Reproducibility of Repeated Measurements

In this type of study the SOS of each subject was measured at the given skeletal site using the appropriate probe type twice by three different operators. Probes were repositioned between each measurement. The CV was reported for all measurements, as well as stratified by operator and by menopausal status. The variance of each CV was also calculated so that 95% confidence intervals could be reported. Fifteen subjects were measured, 10 premenopausal women and 5 postmenopausal women. This kind of precision result is often called "Short Term Precision".

Since there were 15 subjects measured by three different operators, a total of 45 pairs of repeated SOS measurements are available to assess the reproducibility of repeated measurements. 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-score (TSD) is 0.164 (16.4%). For pre-menopausal women the radius TSD was 0.119 (11.9%) and for post-menopausal women the radius TSD was 0.229 (22.9%).

The short term precision results for all skeletal sites is shown in Table 2.5.

Table 2.5 Precision Test Results for Each of the Skeletal Sites

RMS Intra

Skeletal Site

Radius 0.40 16.4

Phalanx 0.81 19.0

Metatarsal 0.66 11.8

Operator CV (%)

T-S cor e Precision (%)

Conclusions

The in vivo precision (reproducibility), expressed by CV, for the

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Essential Prescribing Information

Omnisense system when performing repeated SOS measurements at the various skeletal sites was good regardless of the ultrasound probe, the system, the probe connecting slots within each main unit, or the operator used to perform the measurement. Results indicated reproducibility regardless of the hardware used or the operator performing the measurements, and demonstrated narrow dispersion of the SOS measurement results.

The in vivo precision of repeated Omnisense measurements in the same subject ranged from CV of 0.40 to 0.81%, depending on the site measured. In all the sites, there were some relative differences in CV between premenopausal and postmenopausal subjects. Differences in precision between premenopausal subjects and postmenopausal subjects have been found in DXA measurements (postmenopausal CV higher than premenopausal CV) as well as in QUS measurements of the calcaneus (postmenopausal CV lower than premenopausal CV). There were also differences between CVs measured by different operators. Nevertheless, all CVs were well below 1%, indicating precision for all subgroups, and thus allowing for a meaningful assessment of patient status relative to the reference range.

2-16 User Guide

Table 2.6 shows the method of Glüer used to determine trend assessment intervals (for follow-up when large changes are expected, such as after commencement of specific intervention) and monitoring time intervals (between successive regular check-ups). The Response Rate is the annual change in the early menopausal years. The Precision Error is taken from postmenopausal women in the SUN-11 Precision Study. Trend Assessment Margin and Least Significant Change are 1.8 and

2.8 times the Precision error respectively. Trend assessment Interval and Monitoring Time Interval are the TAM and LSC divided by the Response Rate respectively.

Individualization of Treatment

Table 2.6 Description of the Time Intervals for Repeated

Measurement for Each of the Skeletal Sites

Skeletal Site

Radius 0.44 0.57 1.03 1.60 2.3 3.6

Phalanx 0.57 0.84 1.51 2.35 2.6 4.1

Metatarsal 0.51 0.79 1.42 2.21 2.8 4.3

Response Rate (%)

Precision Error (%)

Change Criteria (%)

TAM LSC TAI MTI

Follow-up times (years)

(TAM - Trend Assessment Margin; LSC- Least Significant Change; TAI - Trend Assessment Interval; MTI - Monitoring Time Interval)

As can be seen from the table, trends within the early postmenopausal years could be assessed in 2-3 years at any skeletal site. More than three years are needed in order to establish the change with a higher statistical significance. However, bone changes which are caused by positive or negative intervention could generate, if effective, larger response rates compared to the normal average 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 osteoporosis and other conditions leading to reduced bone strength and bone fragility.

The following detailed information is intended to guide the physician on how to interpret the Omnisense results and its relationship to the currently accepted densitometry methods.

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Essential Prescribing Information

SOS Result, T-Score and Z-Score - Definitions

Any patient measurement result consists of three different parameters:

1. The absolute result of the measured Speed of Sound (SOS)

expressed in units of meters per second (m/sec). For the purposes of the following definitions, the term young healthy population is defined as that age group in which bone mineral density (BMD) is at its peak (Kanis et al. 1997). For devices that show BMD to be constant between ages 20 to 40 it is typical to use the average value for ages 20 to 40 as the young healthy population reference value. However, Sunlight found that SOS was not constant between ages 20 and 40, but instead gradually increases starting at age 20 and reaches a peak at around age 40 for most of the skeletal sites. Thus, the "young healthy population" mean is taken as the "peak bone SOS", based on averaging the population SOS values within 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 standard deviation. Positive value means that the measured result is above the peak average SOS, while negative value represents a value which is lower than the peak average SOS. A value of T = -2 means that the SOS of the patient is two population standard deviations below the peak average SOS.

3. Z-score - The difference between the patient's SOS result

and the average SOS of a population of the same age, gender, and ethnic group in units of population standard deviation. A value of Z=+0.5 means that the SOS of the patient is half a population standard deviation above the mean of her age-matched peers and ethnicity.

2-18 User Guide

T and Z-scores provide additional information for bone assessment because they take into account both the mean and statisti-

Individualization of Treatment

cal distribution of population reference values. Those results, together with the patient's clinical profile, provide the physician with useful data on which therapeutic decisions can be based.

Omnisense 7000S/8000S has the capability to perform SOS measurements at multiple skeletal sites (i.e., distal 1/3 radius, phalanx, and metatarsal). Clinical studies performed with the Omnisense 7000S/8000S demonstrated that SOS measurements of any of the three skeletal sites were valid for use in diagnosing osteoporosis. The availability of multiple skeletal sites provides 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 7000S/ 8000S has different physiological (e.g., different combinations of cortical and cancellous bone) and weight-bearing characteristics that may provide the physician with additional assessments of a patient's bone status and confirm any concerns regarding osteoporotic fracture risk.

On the next page is an example of a patient report, showing the above results as measured by Omnisense.

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Essential Prescribing Information

Figure 2.2 Example of a Measurement Report

2-20 User Guide

Individualization of Treatment

Bone Ultrasonometry and Fracture Risk

The Omnisense-reported T-scores can be used to assess a patient's risk of osteoporotic fracture in a manner similar to that used in X-ray absorptiometry.

In 1994, a Study Group commissioned by the World Health Organization (WHO) has proposed clear guidelines for physicians diagnosing osteoporosis, based on T-scores:

a. Normal. T-score above -1.0.

b. Osteopenia. T-score between -1.0 and -2.5.

c. Osteoporosis. T-score below -2.5.

These cut-off values related initially to Bone Mineral Density (BMD) measured at the forearm. Nevertheless, they were shortly adopted for axial BMD measurements, including BMD of the spine and the hip, whereby the lowest value reported is usually considered for diagnostic purposes (Kanis et al. 1994).

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, family history, corticosteroids use, etc. in patient evaluation.

Concerning risk of fracture, research shows that the odds ratio of osteoporotic hip fractured to non-fractured subjects measured by Omnisense is about 1.5. That means that a decrease of

1.5 T-score units corresponds to a 50% increase in the odds of hip fracture while a decrease of about 2.5 T-score units doubles the odds of hip fracture.

Monitoring Bone Changes

Monitoring trends within the early postmenopausal years may be assessed every 2 to 3 years at any of the three skeletal sites

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Essential Prescribing Information

for which Omnisense is indicated. More than 3 years are needed in order to establish the change with a higher statistical significance. Bone changes, which are caused by positive or negative intervention (i.e., the positive effect of extensive weight bearing physical activity or treatment with bone formation agents, or negative effect of steroid treatment), could generate larger response rates compared to normal average populations, requiring shorter monitoring time intervals. SOS measurements from one skeletal site may be different than those from another skeletal site. Accordingly, when monitoring bone changes in early postmenopausal women, SOS measurements from one skeletal site cannot and should 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 summary of the importance of bone density testing and information about the Omnisense Bone Sonometer.

2.10 Conformance to Standards

2-22 User Guide

The Sunlight Omnisense® Bone Sonometer conforms to U.S. and international standards, as described below, for safety, electromagnetic compatibility and acoustic output relative to ultra-

sound devices. The Sunlight Omnisense

Bone Sonometer generates and emits ultrasonic energy. Emissions have been tested and found to be in conformance with the accepted standard limits for medical diagnostic devices of this type.

Non-clinical testing demonstrated conformance to the following international standards:

IEC 60601-1 (EN 60601-1) Medical electrical equipment, Part 1: General requirements for safety.

Conformance to Standards

IEC 60601-1-2 (EN 60601-1-2) Medical electrical equipment electromagnetic compatibility - Requirements and tests.

IEC 61157: 1993 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment

NEMA, UD-2, revision 2: 1997 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

FDA Guide 510(k) Track 1 Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices (1985); and FDA 510(k) Guidance: "Information for Manufacturers Seeking Marketing 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 provisions of the Medical Device Directive 93/42/EEC and has been certified by KEMA EC Notified Body (Identification number

0344) for CE Marking of Conformity of Medical Devices. Certificate number 93741CE01 issued by KEMA July

Monitors, printers and other the Sunlight Omnisense

interfacing accessories used with

Bone Sonometer must meet IEC 601-

10, 1998.

1, IEC 950, UL 2601 or equivalent safety standards.

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Essential Prescribing Information

2.11 How Supplied

Omnisense is supplied in one of two possible versions, an Omnisense 7000S desktop version or an Omnisense 8000S mobile version.

The Omnisense 7000S packaging includes the following:

• Main Unit,

• Keyboard and Mouse,

• A color display LCD monitor,

• Ultrasound probes according to order specification (each

probe contains a set of transducers, some acting as transmitters and the others acting as receivers, housed tightly together in a compact holder),

• Foot Pedal,

• System Quality Verification Phantom,

2-24 User Guide

• 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 80

00S packaging includes the following:

• Main Unit with self-contained monitor,

• Keyboard and Mouse,

• Ultrasound probes according to order specification (each

probe contains a set of transducers, some acting as transmitters and the others acting as receivers, housed tightly together in a compact holder),

Operators Manual

• 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).

Also, included as a 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, Delmas P, Burckhardt C, Cooper C, and Torgerson D. Guidelines for diagnosis and management of osteoporosis. Osteoporos Int 1997; 7:390-406.

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Gluer C-C. Monitoring skeletal changes by radiological techniques J Bone Miner Res 1999; 14:1952-1962.

Barkmann R, Kantorovich E, Singal C, Hans D, Genant HK, Heller M, and Gluer C-C. A new method for quantitative ultrasound measurements at multiple skeletal sites. J Clin Densitometry 2000 Spring; 7(1):1-7.

Hans D, Srivastav SK, Singal C, Barkmann R, Njeh CF, Kantorovich 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(4):644-651.

2-26 User Guide

CHAPTER 3 Introducing Sunlight Omnisense

7000S/8000S

Sunlight Omnisense® 7000S/8000S (“Omnisense”) introduces a step up in accuracy and cost effectiveness for the assessment of the risk of osteoporotic fracture. It is the only quantitative ultrasound (QUS) system to offer the capability to measure at multiple skeletal sites in a device intended for primary care.

This chapter presents a general description of the Omnisense system — background information on QUS methods, Omnisense technology, significance of Omnisense results and use of Omnisense in diagnosis and treatment.

3.1 Quantitative Ultrasound

Ultrasound is well established in the medical community as a safe and cost-effective modality. The method is widely known in its qualitative mode — for example when used to obtain invivo views of the heart or fetus. Ultrasound can also be used in a quantitative mode, by measuring various parameters associated 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 status, primarily because it offers reliable, quick and relatively low cost results without the potentially harmful radiation associated with other traditional techniques such as radiography, X-ray absorptiometry and computed tomography. Avoidance of unnecessary exposure to harmful radiation is especially important in the primary care setting for which Omnisense was designed.

THE PHYSICAL BASIS OF QUS

Sound energy consists of alternating cycles of compression and relaxation (rarefaction) of the medium through which it is trans-

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Introducing Sunlight Omnisense® 7000S/8000S

mitted. Audible sound for humans is in the range of 20 Hz to 20,000 Hz (20 kHz). Ultrasound refers to a range of frequencies that begin at the end of the audible range and extend into the Megahertz range.

The propagation of ultrasound through a medium, its speed, dispersion and attenuation of signal strength are strongly influenced by the physical properties of that medium. QUS takes advantages of these influences to draw conclusions about the physical properties of bone through which an ultrasound signal is traveling. Two measures are in common use: the attenuation (change in amplitude) of the signal, and the speed of its trans- mission through bone. The latter measure, commonly abbreviated SOS (for Speed of Sound) is the one used by Omnisense.

While based on the same principle as other QUS devices, Omnisense is distinct in its unique Omnipath 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 slowly than through either type of bone, and propagation through air is practically nonexistent. Omnisense relies on this fact for its operation.

PROBES

Omnisense employs hand-held probes to generate and detect ultrasound waves. Each probe contains a number of transducers, some of which serve as ultrasound signal generators while others function as detectors. During measurement, the probe is applied directly to the skin at the region of interest. In case probe caps are used, a layer of ultrasound gel is applied between the probe surface and the probe cap. A probe cap is mounted over the probe measuring surface, with the cap’s front skin in good contact with

Axial Transmis-

3-2 User Guide

Omnisense Technology - Omnipath®

the gel with no air bubbles showing. Another uniform layer of gel is applied to the probe cap surface and the skin to facilitate good acoustic coupling. Ultrasound is emitted by the generating transducers, transmitted along the bone and then received at the detectors. Figure 3.1, "The Omnisense probe‚" page 3-3 illustrates the functioning of the probe.

Figure 3.1 The Omnisense probe

a b

IGNAL PATH

As seen in the figure, sound waves are propagated in all directions from the transmitting transducer. Every molecule in the medium acts as a new transmitter, thus propagating the signal again in all directions. It follows that there are many paths that the signal can follow from transmitter to receiver. Omnisense derives useful information from this scenario by detecting the first signal to arrive at the receiving transducer. The path of this signal is determined by Snell’s Law: upon entering the bone the signal is refracted through a critical angle which is a function of the ratio of speed of sound in soft tissue versus speed of sound in bone, it propagates along the bone and then scatters out of the bone at the same critical angle. The time taken by the signal to travel between the points a and b is the parameter measured by Omnisense. Proprietary techniques subtract the time during

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Introducing Sunlight Omnisense® 7000S/8000S

which the signal travels through soft tissue.

The Primary Care Unit

Omnisense 7000 is a table-top unit that may be carried from room to room without difficulty, and Omnisense 8000 is designed for mobility. Probes are hand-held and applied directly to the patient’s skin. Operation of the unit is completely straightforward: SOS measurements take a few minutes and can be carried out by typical clinic personnel after instruction and hands-on training.

With its high accuracy, portability, low cost and ease of use, Omnisense is tailor-made for the primary care clinic when used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk.

3.3 Relationship between Omnisense Results

3-4 User Guide

and Risk of Fracture

Use of the Omnisense Bone Sonometer in the assessment of fracture risk is based firstly on the results of clinical studies designed specifically for Omnisense, and secondly on known results for quantitative ultrasound methods in general.

Sunlight has conducted cross-sectional clinical studies which have demonstrated that the Omnisense Bone Sonometer discriminates effectively between subjects with osteoporotic fractures and subjects without fracture. Key statistical measures of the predictive ability of SOS, the Odds Ratio and ROC (area) have been found generally higher than equivalent measures of the predictive ability of other bone assessment techniques, including Dual X-ray Absorptiometry (DXA) and heel bone sonometers.

Relationship between Omnisense Results and Risk of Fracture

Omnisense Innovations

Omnisense introduces a number of innovations as regards the accuracy and significance of SOS results when used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk.

MULTI-SITE CAPABILITY

When using Omnisense, you apply a simple hand-held probe to the site at which SOS is being measured. The probe may be applied to different sites; in some cases different sites require switching probes. The basic Omnisense unit is the same for all sites. Currently, skeletal sites at which SOS may be measured with Omnisense are the distal 1/3 radius, third proximal phalanx and the fifth metatarsal. Reference databases for all of the above are available with the current release of Omnisense.

Preliminary studies suggest that improved diagnostic accuracy is achieved when assessment is based on SOS measurement

1, 2

results from multiple sites

. In addition, patients may be assessed even when a particular site is injured or otherwise inappropriate for scanning.

CORRELATION WITH STRUCTURAL BONE FEATURES

Traditional measures of fracture risk are based on the density of bone. However, it is well known that bone strength depends on a variety of factors of which density is only one. In particular, structural features play a key role in determining a bone’s ability to resist trauma. As a simple illustration, bones such as the tibia and radius can withstand much greater stress along their tubular axis - the direction which naturally carries body weight

- than at right angles to this axis, despite the fact that density

1. D.Hans, S.K. Srivastav, C.Singal, R. Barkmann, C.F. Njeh, E.Kantorovich, C.C. Gluer and

H.K.Genant: Does Combining the Results from Multiple Bone Sites Measured by New Quantitative Ultrasound Device Improved Discrimination of Hip Fracture?” JBMR 1999; 14:644-651

2. R. Barkmann, E. Kantorovich, C. Singal, D. Hans, H.K.Genant, M. Heller, and C.C. Gluer: “A

New Method for Quantitative Ultrasound Measurements at Multiple Skeletal Sites: First Result of Precision and Fracture Discrimination” J Clin Densitom 2000; 3:1-7

Omnisense 7000S/8000S 3-5

CHAPTER 3

Introducing Sunlight Omnisense® 7000S/8000S

remains identical in both situations. Ongoing studies suggest that Omnisense SOS results are related more directly to bone strength than a simple density measure such as Bone Mineral Density (BMD).

INCREASED PREDICTIVE ABILITY

As described above, Omnisense brings two advances in accuracy to osteoporotic risk assessment. First, its multi-site capability 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 assessment capability more reliable than has been available until now.

A SYSTEM THAT GROWS

To add an additional application or measurement site to the Omnisense capability, one simply installs a software upgrade, and in some cases, additional hardware. The base system remains unchanged.

3-6 User Guide

CHAPTER 4 Initial Setup

This chapter guides you through your first use of Omnisense, beginning with unpacking the system, connecting cables, power up and first time login to the software system.

4.1 Examination Room Environment

A few basic guidelines should be followed when choosing the room in which SOS measurement will be conducted with Omnisense.

• An examination room is recommended in which extreme temperatures are avoided, even when the unit is not in use. In particular, System Quality Verification cannot be conducted when the phantom temperature is outside the range of 15-30 degrees Centigrade. If, for example, the examination room temperature was below this range during the night, a wait period will be required while the phantom stabilizes 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 position the unit near a heat source or air-conditioner.

• The examination room should have a standard electrical outlet, a stationary chair for the patient, and a table or desktop on which the patient may comfortably rest an arm or hand. The Omnisense operator should be seated on a chair which can be easily moved around, such as an exam stool.

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Initial Setup

Please ensure that the wall outlet to be used for Omnisense is equipped with a proper grounding connection, and complies with the IEC 601-1 and local country standards requirements. Please ensure that the main unit power cable plug is of the appropriate type for the wall outlet.

4.2 Unpacking Omnisense

Immediately upon receipt of Omnisense, check the Shock Watch indicator located on the side panel of the box. If the indicator is RED, please note this condition on the bill of lading and call a Sunlight representative.

4.2.1 Unpacking Omnisense 7000S

4-2 User Guide

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) and power supply cable,

• Flat color display monitor (LCD) with an isolation transformer,

• Keyboard and mouse,

• Probes as per your order,

• Foot pedal with connecting cable,

• One System Quality Verification Phantom,

• Accessories (per skeletal sites ordered),

• Starter kit,

• User Guide,

• Quick Reference Guide (only available in languages other

than English).

All software is pre-installed in the Omnisense unit.

If any of the components are damaged, missing, or different than those ordered, contact Sunlight Customer Support as soon as possible.

Save the packing material in which Omnisense was shipped, in case it must be moved to another location, or returned for service.

4.2.2 Unpacking Omnisense 8000S

Unpacking Omnisense

• 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 skeletal sites ordered),

• Formatted CD-RW diskette,

• User Guide,

• Quick Reference Guide (only available in languages other

than English).

All software is pre-installed in the Omnisense 8000S device.

If any of the components are damaged, missing, or different than those ordered, contact Sunlight Customer Support as soon

Omnisense 7000S/8000S 4-3

CHAPTER 4

Initial Setup

as possible.

4.3 Identifying System Components

The figures which follow illustrate the components of your Omnisense System. 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.

4-4 User Guide

Identifying System Components

Figure 4.1 The Omnisense main unit — front view

Table 4.1 Front Panel indicators and ports

1 — Probes

2 — Probes holder

3 — ZIP

4 — 3.5” diskette slot

5 — Hard disk drive LED indicator

6 — Omnisense operation LED indicatorr

7 — Main power switch

drive slot (in some models,

CD-RW slot)

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Initial Setup

The probes used for scanning skeletal sites and all other cables and connectors connect to sockets and ports on the rear panel (see Figure 4.2). The rear panel of the Omnisense unit is illustrated in the next figure. Familiarize yourself with the sockets at the back of the unit, and check that they correspond to those specified below.

Figure 4.2 The Omnisense main unit — rear view

3456789

4-6 User Guide

10 11 12 13 14

Table 4.2 Rear Panel sockets and ports

1 Probe slots

2 Type B (IEC 601-1) symbol

3 USB socket

4 Network socket

5 Keyboard socket

6 Mouse socket

7 Earphone socket (optional)

8 Power outlet for LCD monitor

Identifying System Components

9 AC power inlet

10 Printer output

11 Monitor data socket

12 COM2 (not used)

13 Foot-pedal socket (COM1)

14 Additional Grounding (earth) connector

When conducting an SOS measurement, the examiner uses a hand-held probe at the area of interest, applied directly to the patient’s skin.

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Initial Setup

4.3.2 Identifying System Components for Omnisense 8000S

The next figures illustrate the Omnisense 8000S device front, side, and rear panels. Verify that the unit you received has connectors and features as described below.

Figure 4.3 Omnisense 8000S — front view

4-8 User Guide

Identifying System Components

Figure 4.4 Omnisense 8000S — side view

Table 4.3 Side Panel Drives

8 — 3.5” diskette slot

9 — CD-RW

10 — PCMCIA slot

drive slot

The probes used for scanning skeletal sites and all other cables and connectors connect to sockets and ports on the rear panel (see 4.2 on page 4-6). Familiarize yourself with the sockets at the back of the unit, and check that they correspond to those specified below.

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Initial Setup

Figure 4.5 Omnisense 8000S — rear view

2 3 45 6 7 8 9 10

4-10 User Guide

Table 4.4 Omnisense 8000 Rear Panel Sockets and Ports

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)

4.4 Measurement Accessories

The phantom has an LCD temperature gauge on one side, and a conversion table on the other.

Measurement Accessories

The photograph below shows a “phantom”. The phantom is constructed of Perspex material which has known, stable SOS behavior. It is used to verify that Omnisense is measuring speed of sound accurately. The procedure is described in Chapter 6, "System Quality Verification‚" page 6-1.

Figure 4.6 Phantom for system quality verification

The hand rest supports the lateral edge of the outstretched palm when scanning the radius.

A hand rest is provided with Omnisense for use in positioning a patient’s arm correctly for a SOS measurement of the distal 1/3 radius. The hand rest is illustrated in the photograph below.

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 correct location, Omnisense is shipped with one or

Omnisense 7000S/8000S 4-11

CHAPTER 4

At left is the gauge used to locate the scan site for the radius. The gauge at right is used to locate the scan site at the proximal phalanx and the metatarsal.

Initial Setup

two measuring gauges. Their use is described in 8.3, “Locating the Measurement Site”, on page 8-5, and in Chapter 15, "Site Measurement Methodologies‚" page 15-1. The gauges are illustrated in the photographs below.

Figure 4.8 Measuring gauges

The phantom (see Figure 4.6, "Phantom for system quality verification‚" page 4-11), limb positioning fixtures (see Figure 4.7, "Limb positioning fixtures‚" page 4-11), and measurement gauges (see Figure 4.8, "Measuring gauges‚" page 4-12) are the same for Omnisense 7000S and 8000S.

4.5 Cable Connections

4.5.1 Cable Connections for Omnisense 7000S

4-12 User Guide

The Omnisense system is designed for easy set-up. Once you have determined that you have all the necessary parts, follow the procedure below.

Unit Setup Procedure

STEP 1 Position the Omnisense Unit

Place the main Omnisense unit on the surface where it will be operated. Ensure that it is within reach of a standard electrical outlet and that it is well away

Cable Connections

from any source of heat or air-conditioning. Ensure also that there is room for patient and operator chairs near the unit, and that sufficient desk or table space is available for a patient to rest an arm comfortably.

STEP 2 Attach Rear Panel Connector Cables

Insert each component connector securely into the corresponding socket and tighten the screws if required (refer to 4.2 on page 4-6).

• Insert one end of the color display monitor data cable connector into the monitor socket on the rear panel of the main unit ("11 Monitor data socket" in Figure 4.2, "The Omnisense main unit — rear view‚" page 4-6) and 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 monitor.The monitor receives electricity through the main unit, and does not need to be connected separately to a source of electricity.

• Insert the keyboard connector into the keyboard socket ("5 Keyboard socket" in the figure), and the mouse connector into the mouse socket ("6 Mouse socket" in the figure). In case a keyboard with integrated track ball is used, the keyboard connector is the one with two cables connected to it; the trackball connector has only one and should be connected to the mouse socket. Each connector/cable has the corresponding labeling.

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Initial Setup

• If you are installing a printer to be used with Omnisense, insert the printer connector into the printer socket ("10 Printer output" in the figure).

• Connect the foot pedal to the main unit by inserting its connector into the foot pedal socket ("13 Foot-pedal socket (COM1)" in the figure).

Important safeguards/notices for printer or other peripheral equipment installation:

1. All the equipment connected to Sunlight Omnisense

shall be certified according to standard IEC601-1, UL2601, IEC950 or other IEC/ISO standards, or equivalent, applicable 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 terminal to system ground unless it is certified according to standard IEC601-1or UL2601, or equivalent safety standard.

3. The leakage current could increase when connected to other

equipment.

4-14 User Guide

STEP 3 Connect Probes

Probes should be attached to the unit during initial setup and left connected at all times. After initial setup, probes are connected/disconnected only when adding new probes or transporting Omnisense.

The correct procedure for connecting probes is illustrated in the following photograph.

Figure 4.9 Pins on a probe connector

Note carefully the arrangement of pins on the probe connector. Ensure that you insert the connector into a probe socket so that corresponding pins are aligned. Probes may be inserted into either of the two leftside sockets. Press the connector firmly into its socket. Tighten the locking screws, as this ensures proper electrical ground. Repeat this procedure for the second probe and tighten locking screws.

Cable Connections

STEP 4 Electrical Power Connection

The following are normally done once, during initial setup.

• Note carefully the power rating of your Omnisense unit (230 or 110 V autoswitchable) and insure that you are using an electrical outlet with either rating.

• 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.

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Initial Setup

Ensure that the wall outlet used for Omnisense is equipped with a proper grounding connection, and complies with IEC 601-1 standards requirements.

• During normal use, Omnisense is powered on with the front panel power switch ("2 Power switch" in 4.1, “The Omnisense main unit — front view”, on page 4-5).

Before attempting to connect or disconnect Omnisense from the main power, ensure that the main unit power switch, located on the front panel, is off.

4.5.2 Cable Connections for Omnisense 8000S

4-16 User Guide

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-conditioner. Ensure also that there is room for patient and operator chairs near the unit, and that sufficient desk or table space is available for a patient to rest an arm comfortably.

STEP 2 Attach Rear Panel Connector Cables

Insert each component connector securely into the corresponding socket and tighten the screws if required (refer to 4.2 on page 4-6).

Cable Connections

• Insert the keyboard/mouse connector into the keyboard socket ("7 Keyboard/Mouse socket" in the figure).

• If you are installing a printer to be used with Omnisense, insert the printer connector into the printer socket ("8 Printer output" in the figure).

• Connect the foot pedal to the main unit by inserting its connector into the foot pedal socket ("9 Foot-pedal socket (COM1)"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, applicable 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 unless it is certified according to standard IEC 60601-1or UL2601, or equivalent safety standard.

3. The leakage current could increase when connected to other

equipment.

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Initial Setup

STEP 3 Connect Probes

Probes should be attached to the unit during initial setup.

Note carefully the arrangement of pins on the probe connector, as seen in Figure 4.9, "Pins on a probe connector‚" page 4-15. Ensure that you insert the connector into a probe socket (seen in 4.9, “Pins on a probe connector”, on page 4-15) so that corresponding pins are aligned. Probes may be inserted into either of the two sockets at the back of the device. Press the connector firmly into its socket. Tighten the locking screws, as this ensures proper electrical ground. Repeat this procedure for the second probe and tighten locking screws.

Figure 4.10 Probe slots on Omnisense 8000

4-18 User Guide

STEP 4 Electrical Power Connection

• Ensure that the main unit power switch ( 2 Power switch in the rear panel, 4.5 on page 4-

10) is off.

• Attach the Omnisense unit power cable to the appropriate socket on the rear panel ( 3 Power socket in 4.5 on page 4-10). Plug the other end of the cable into a standard electrical outlet.

• During normal use, Omnisense is powered on with the rear panel power switch ( 2 Power switch in 4.5 on page 4-10).

4.6 Power On the System

Start the system by pressing the main power switch, on the front panel of the main unit for 7000S and at the back of the device for 8000S. The device will go through a short software initialization procedure.

The Sunlight Desktop screen, seen in Figure 4.11, "Sunlight Desktop opening screen‚" page 4-19, will appear.

Figure 4.11 Sunlight Desktop opening screen

Power On the System

Please note that the Desktop contains icons for each of the applications available on the individual device. The Sunlight Omnisense Adults icon is used to enter the Omnisense Adults application; the icon is seen in at the top left in the Sunlight Desktop screen seen in Figure 4.11, "Sunlight Desktop opening screen‚" page 4-19.

4.7 Initial System Access

Click on the Sunlight Omnisense Adults icon on the Sunlight Desktop screen to open the Sunlight Omnisense Adults applica-

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CHAPTER 4

Initial Setup

tion.

Figure 4.12 Initial login dialog box

Once an application has been chosen, the “Please Login” dialog box will appear. This dialog box asks for a user ID and password (if required), to enter the system. Sunlight recommends that you take advantage of Omnisense security features by setting a safe password for the system administrator (highest level user), as well as encouraging all personnel who will use the system to set passwords for themselves.

4-20 User Guide

The procedure described below shows how to enter the system for the first time, when no passwords have been set. This is followed immediately by the procedure for setting passwords. All subsequent entry to the system should be via assigned passwords.

Changing the System Password

Sunlight provides an initial ID and password for first-time entry into the Omnisense software system. The default ID is sunlight and the default password is omni (all lowercase). Once you have entered the system, you can create your own user IDs and passwords, as explained following this procedure.

Initial Access Procedure

STEP 1 Enter Your Operator ID Number

At the blinking cursor in the User Name field, type the user ID provided by Sunlight:

• Check that you have typed it in correctly.

• If it is incorrect, use the backspace key to delete

and retype it correctly.

• Press TAB to move to the

sunlight.

Password field.

STEP 2 Enter the System Password

In the Password field, type in the password provided by Sunlight: are displayed when you type into the field, instead of the actual password characters.

omni. Asterisks (the symbol *)

STEP 3 Complete Initial Access

To complete the access procedure, click OK. This will bring up the main Omnisense screen.

4.8 Changing the System Password

When you enter Omnisense with the Sunlight-provided user ID and password, you are operating at the system level. This is the highest level of access, usually reserved for the person responsible for system administration. The next step is to change the

Omnisense 7000S/8000S 4-21

Password

CHAPTER 4

Initial Setup

password for system level access to one of your choice. First, select this brings up the User List screen.

Figure 4.13 User List screen

List of users from the Administration menu;

Administration>List of Users 

OK or Cancel 

Choose Change Password and the following dialog box appears.

4-22 User Guide

Figure 4.14 Change password dialog box

Administration>List of Users>Change Password 

OK or Cancel 

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

to add additional user IDs. For complete details on administration using the Omnisense system, user status, passwords and access to patient information, see “Chapter 10, System Administration.”

4.9 Adding Users

Omnisense recognizes two types of users, in addition to the System Administrator — physicians and operators. The two types are distinguished by the privileges they have. Operators may conduct SOS measurements on the patients of physicians for whom they work. Physicians can change the status of operators to allow them to conduct SOS measurements for their patients; operators cannot change their own status. Also, physicians can add other physicians or operators as users, while operators can add only additional operators. All users must enter their own passwords, using above, after being added to the User List.

Adding Users

Change Password as described

Adding users is straightforward, as described below. For full details on the different privileges of the different user types, see Chapter 10, “System Administration”.

Adding users is accomplished with the User List screen, found under the

Administration menu, as illustrated below.

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Initial Setup

Figure 4.15 Adding users with the User List screen

Administration>List of Users 

OK or Cancel 

In the screen above, the user has entered the system with the highest level of access (System Administrator). You can add physician-level user IDs by clicking on the

Add button for the

left window. Similarly, to add operator-level user IDs, click on

Add button at the right window. Use the Remove button if

the you change your mind and wish to delete a user ID.

4.10 The Sunlight Desktop

4-24 User Guide

Note that this procedure only creates a new user ID that is known to the system; it does not assign passwords to those users. Passwords may be set or changed for any user ID only by the users themselves. Initially, a new user does not need a password to enter the system, as described below.

The Sunlight Desktop includes utilities for changing various settings on your device.

Any changes in Date, Time, Mouse Settings, Regional Settings, and Keyboard Font will apply in all applications when changed on the Sunlight Desktop. Similarly, if these settings are changed in any application, the new settings will apply also on the Sunlight Desktop.

Any change in the language of the Sunlight Desktop will apply only to the Sunlight Desktop. To change the language of an application installed on the Desktop, change the language within the application software. Any change of language in one application will apply in other applications as well, except in special cases.

For details about setting options for the Sunlight Desktop, see CHAPTER 11, "The Sunlight Desktop‚" page 11-1.

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

Setting the System Time

Administration>Options 

OK or Cancel 

Click on Date/Time at the bottom of the dialog box, and choose the Time Zone tab. The Time Zone dialog box is illustrated next. To view the list of available time zone options, click on the drop-down arrow to the right of the first line. Select the desired time zone and click

OK (Figure 4.17).

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CHAPTER 4

Initial Setup

Next, click on the Date & Time tab. Enter the date and time in the indicated fields using the Up/Down or selection arrows.

OK and the system date and time are set (Figure 4.18).

Click

Figure 4.17 Time Zone screen

Administration>Options>Settings>Date/Time>TimeZone 

4-26 User Guide

OK or Cancel 

Figure 4.18 Date/Time settings

Administration>Options>Settings>Date/Time 

Setting System Default Options

4.12 Setting System Default Options

When installing the system at your clinic, it is recommended to set all relevant system defaults that influence both everyday work and system printouts. These include the default reference database to be used, definitions of height and weight measurement units, clinic information, language selection, regional set-

Omnisense 7000S/8000S 4-27

OK or Cancel 

CHAPTER 4

Initial Setup

tings, and all other relevant parameters. Please refer to Chapter 10, "System Administration‚" page 10-1 for a complete detailed description of all these functions.

4.13 New User Entry

A new user enters the Omnisense system for the 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

On System startup 

4-28 User Guide

OK 

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

screen to set a password, as illustrated next.

Additional Applications

Figure 4.20 Setting a new password with the List of Users

screen

Administration>List of Users 

OK or Cancel 

Click on the Change Password button; the Change Password dialog box is displayed. Since there is no previous password, leave the first field blank. Enter your chosen password in the second field, press TAB and enter it again in the last field. Click

OK to complete the procedure.

4.14 Additional Applications

A number of additional applications are available with the Sunlight 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 applications during your working day. You need not shut down the device and start it again to do so; instead, Omnisense provides two methods for switching between applications.

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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.

4-30 User Guide

CHAPTER 5 Working with Omnisense

This chapter provides a high-level guide to navigating Omnisense system functions.

5.1 Basic Operations

Omnisense functions support two basic types of operations — Measurement Operations and Management Operations. Your time spent with Omnisense is divided between these types as follows:

Measurement Operations. All aspects of SOS measurement

are handled here — the SOS measurement itself and viewing/ printing measurement results. System Quality Verification is also considered part of measurement operations.

Management Operations. These cover all functions not

directly related to SOS measurement. Included are user security and management, patient security and management, utilities for installing and configuring printers and data storage and backup operations.

Management operations are not available during measurement. Similarly, most measurement operations may not be performed while a management function is active.

On the next two pages you will find a graphical tour of all main features of the Omnisense system. The diagram on page 5-2 describes Measurement operations, and the diagram on page 5-3 gives details of Management operations. The graphical description is followed by tables which provide more detail on the different operations available and how to access them.

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Working with Omnisense

Omnisense Measurement Mode

Measurement Options

Measurement Mode is where

you will spend most of your

time when working with

Omnisense. To enter

measurement mode, you

must have a patient file open,

except when performing

System Quality Verification.

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

Open patient file.

Choose the skeletal site.

5-2 User Guide

Patient History may be viewed in any mode

for the current patient.

Omnisense Management Mode

Management mode is for all functions not directly related to SOS measurement. These include setting various

default parameters, user security, patient management and various utilities for storage and backup. Patient

History may be viewed from both Management Mode and Measurement Mode.

View Measurement Data

- Open/Close/Edit/Delete Patient

- Show Patient History

- Print

Opens a new patient

Goes to measurement mode

Opens patient measurement

history

Basic Operations

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

Prints results

Displays an instructional video

on measurement method

Tracks down scheduled

measurements

System Administration

- List of Users

- Patient Management

- Visit Scheduler

- Service

- System Upgrade

- Site Order

- Options

- Applications

Utilities

Backup

Restore

License Status

Print Setup

Scan Disk

Disk Compress

Database

Clear Printer Queue

Format Diskette

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CHAPTER 5

Working with Omnisense

Table 5.1 Measurement operations

Measurement Operations

Operation Description

Start Measurement

Switching to Management operations

To start a patient SOS measurement, the patient’s file must first be opened. For an SQV measurement, proceed directly with one of the following.

To start the measurement —

• Click on the Measurement button

on the toolbar, or:

• Select the Measure! menu head-

ing.

Note: Once a Measurement operation has been started in one of the above ways, Patient Import/Export and all Administration functions are not available. During a typical work day with Omnisense, the Measurement screen is continuously displayed, while patient files are opened and closed. Management operations are used relatively infrequently.

To enable Management operations —

If a patient file is currently open

Close the patient file.

5-4 User Guide

If the results of a measurement are displayed

Choose Save or Abort, then close the current patient file.

If a measurement is currently in progress

Complete the measurement or click Abort; close the current patient file.

Measurement Operations

Operation Description

Basic Operations

Measurement

Measurement Result

This part of the screen has two indicators which provide feedback during SOS measurement. These guide the operator and insure correct acoustic contact with the area being scanned (8.4, “Understanding the Omnisense Measurement Screen”, on page 8-8).

Before viewing results, a measurement must be repeated at least three times with statistically consistent results. Each iteration of measurement is called a

Measurement Cycle. The final Measure- ment Result is an averaging of the

results of three consistent measurement cycles (8.4, “Understanding the Omnisense Measurement Screen”, on page 8-8).

When a measurement has been successfully completed, the Result button becomes active and you can view the Measurement Result screen (9.1, “Viewing Measurement Results”, on page 9-

1). Results can also be printed.

Measurement History

A patient’s SOS measurement history may be viewed whenever the patient’s file is open (9.3, “Measurement History”, on page 9-8). Click on the Measurement History toolbar button. History information can also be printed.

Omnisense 7000S/8000S 5-5

CHAPTER 5

Working with Omnisense

The next table describes the key Management operations.

Table 5.2 Management operations

Management Operations

Function Description

Enabling Management operations

Enter/Exit Omnisense

Management operations are available by default when you first enter the Omnisense system.

However, once you have opened a patient file or started a measurement, certain Management operations are no longer available. To access them, complete or abort the current measurement — if a measurement is in progress, save or abort the results and close the current patient file (if open).

Three of the operations listed below are not specifically Measurement or Management related and are available whether or not a patient file is open. These are Set Measurement Type, Set Skeletal Site and Open/Close Patient.

To shut down Omnisense, select Exit from the Patient menu.

The Exit function is also used when you wish to enter the Omnisense system with a different user ID. The procedure is described later in this chapter (5.2, “Changing Users and Shutdown”, on page 5-12).

Exit/Entry are not accessible when a patient file is open.

5-6 User Guide

BeamMed Sunlight Omnisense 8000S, Sunlight Omnisense 7000S User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contact Information

SOFTWARE LICENSE, WARRANTY AND LIMITATION OF LIABILITY

Software License

Limitation of Liability

EXCLUSIVE AND LIMITED ONE YEAR WARRANTY

A Warranty Coverage

B Duration and Commencement of Warranty Period

C Limitation of Warranty

(a) Improper or inadequate maintenance;

(b)Use of any parts or software not supplied by the Company;

(c)Unauthorized modification or misuse of the Product;

(e)Improper site preparation or maintenance;

(f)Accidental damage, whether in transit or otherwise.

D Warranty Card

END USER LICENSE AGREEMENT

3. Protection of Intellectual Property.

Contents

1 Using this Guide 1-1

2 Essential Prescribing Information 2-1

3 Introducing Sunlight Omnisense® 7000S/8000S 3-1

4 Initial Setup 4-1

5 Working with Omnisense 5-1

6 System Quality Verification 6-1

7 Patient Files 7-1

8 Patient SOS Measurement 8-1

9 Interpreting the Results of a Measurement 9-1

10 System Administration 10-1

11 The Sunlight Desktop 11-1

12 Cleaning and Disinfecting Omnisense 12-1

13 Troubleshooting 13-1

14 System Specifications 14-1

15 Site Measurement Methodologies 15-1

16 Utilities and Peripherals 16-1

17 Research Mode 17-1

18 Keyboard Shortcuts 18-1

CHAPTER 1List of Figures

CHAPTER 1 Using this Guide

1.1 Outline of Contents

CHAPTER 1 Using this Guide

1.2 Conventions Used in this Guide

Definitions

Names

FIELDS, BUTTONS, MENU ITEMS AND CHECKBOXES

Procedures, Notes and Warnings

This is a Procedure Heading

STEP 1 Name of first step in Procedure

STEP 2 Name of second step in Procedure

Warning and safety information will be indicated in this style.

Screens

Figure 1.1 Example screen

Important Symbols and Labels

Table 1.1 International Symbols on Omnisense

CHAPTER 2 Essential Prescribing Information

2.1 Device Description

2.2 Intended Use/Indications

2.3 Contraindications

2.4 Warnings

2.5 Precautions

2.6 Adverse Events

2.7 Clinical Studies

2.7.1 Reference Databases

2.7.2 Cross-Sectional Study of Hip Fracture Risk

Table 2.2 SOS Results by Study Group (Radius Only)

2.7.3 Cross-Sectional Study of Hip, Vertebral and Wrist Fracture Risk

Table 2.3 SOS Results by Study Group and Skeletal Site

2.7.4 Precision Studies

Reproducibility of Instruments and Probes

Reproducibility of Operators and Probes

Reproducibility of Repeated Measurements

Table 2.5 Precision Test Results for Each of the Skeletal Sites

Conclusions

2.8 Individualization of Treatment

SOS Result, T-Score and Z-Score - Definitions

Figure 2.2 Example of a Measurement Report

Bone Ultrasonometry and Fracture Risk

Monitoring Bone Changes