CyberLogic, Inc.

UltraScan 650 with NTD® Technology

Ultrasound Forearm Scanner

User Guide

Version 1.9

CyberLogic, Inc.

611 Broadway Suite 707

New York, NY 10012

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Contents

1. WARNINGS ............................................................................................................................................ 3 2. CAUTIONS ............................................................................................................................................. 3 3. INTRODUCTION ................................................................................................................................... 4 4. BASIC OPERATION OVERVIEW ........................................................................................................ 4 5. CONTRAINDICATIONS ....................................................................................................................... 5 6. SETUP ..................................................................................................................................................... 5 7. FREQUENTLY USED INSTRUCTIONS .............................................................................................. 6

7.1 PATIENT (“NEW”) MEASUREMENT .................................................................................................................. 6 7.2 REVIEW MEASUREMENT ................................................................................................................................ 16 7.3 PRINT RESULT ............................................................................................................................................... 18 7.4 QUALITY CONTROL ....................................................................................................................................... 18 7.5 REFERENCE ................................................................................................................................................... 21

8. TROUBLESHOOTING ......................................................................................................................... 21 9. ERROR CODES .................................................................................................................................... 24 10. DEVICE CHARACTERISTICS ....................................................................................................... 25 11. ACCESSORIES / CONSUMABLES ................................................................................................ 27

11.1 ACCESSORIES ................................................................................................................................................ 27 11.2 CONSUMABLES .............................................................................................................................................. 31

12. PERFORMANCE RESULTS SUMMARY .................................................................................... 31 13. DEVICE OPERATION/SAFETY ..................................................................................................... 34 14. CALIBRATION AND MAINTENANCE ........................................................................................ 37

14.1 CLEANING ..................................................................................................................................................... 37 14.2 CALIBRATION ................................................................................................................................................ 37

15. SPECIFICATIONS / REGULATORY STATEMENT ..................................................................... 38

User Manual

Change History

Rev Level Rev Date Approval Comments

1.0 2014 Jonathan J. Kaufman First pass

1.3 12/14 Michael Sturdevant minor changes

1.4 2/9/15 Michael Sturdevant Changes to comply with F Squared

60601 discrepancy report

1.5 4/16/16 Michael Sturdevant,

Paul Dryden

Added EMC tables

1.6 1/17/17 Michael Sturdevant Revised acoustic output section in

response to FDA questions

1.7 2/6/17 Paul Dryden Added use of Exam Table Crepe

1.8 3/29/17 Paul Dryden Updated Indications for Use and added

new label regarding FDA Recommended

Maximum Levels

1.9 06/25/2018 Jonathan J. Kaufman Added new mods for production model.

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1. Indications for Use

UltraScan 650 can be used to determine BMDUS Index in adult men and women and to

assess appendicular fracture risk in postmenopausal women.

The BMDUS Index is a clinical measure based on ultrasound variables of the forearm

which is highly correlated with the value of BMD of the 1/3 radius as provided by

DXA, with a standard error of the estimate of 0.041 grams/cm2.

BMDUS Index is expressed in grams/cm2 and as a T- and z-score, derived from

comparison to a normative x-ray absorptiometry reference database.

BMDUS Index has a precision comparable to that of x-ray absorptiometry, which makes

it suitable for monitoring bone changes in postmenopausal women.

For use by prescription only.

2. Warnings

Warning : Not for use in oxygen rich environments

Warning : Not for use near flammable anesthetics

Warning : To avoid risk of electric shock, this equipment must only be connected

to a supply mains with protective earth.

Warning: Operator must consult the instructions

Warning : Type B Applied Part not suitable for DIRECT CARDIAC

APPLICATION

Warning : No modification of this equipment is allowed

3. Cautions

o The ultrasound transducers and the base on which the arm rests are patient applied

parts.

o Accessories may only be replaced by CyberLogic

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4. Introduction

The UltraScan 650 is an ultrasound device that is designed to non-invasively and

quantitatively assess the amount of bone at the 1/3 location of the radius in the forearm of

an individual. The radius is a well-known site for bone assessment that has been utilized

for over four decades. These previous assessments have used ionizing radiation (x-rays)

to assess the amount of bone at the site. The UltraScan 650, however, uses low energy

ultrasound, the same level of energy used, for example, in the imaging machines used

safely in millions of individuals for decades.

The UltraScan 650, with use of a laptop computer, is an ultrasound bone

sonometer designed for the estimation of bone mineral density (BMD in g/cm2) of the

radius at the 1/3 location. The UltraScan 650 outputs BMDUS, an estimate of the BMD

that would be measured by dual-energy X-ray absorptiometry (DXA) at the same

anatomical location, that is, an estimate of BMDDXA, at the 1/3 radius. The UltraScan

650 also outputs the T-score in standard deviations (SD), and z-score in SD as well. The

precision of the measurement is 2.1%, when expressed as a coefficient of variation. The

range of the output of the UltraScan 650, depends on the subjects that are measured.

However, based on the normative (reference) data, we can calculate the range that will

include 99.85%of all subjects. To do this, use the mean and standard deviation of BMD

of the 85 year old (smallest BMD) woman (0.470g/cm2 and 0.060 g/cm2, respectively)

and the 20 year old (largest BMD) adult male (0.817g/cm2 and 0.053 g/cm2,

respectively). Then the range that will include 99.85% of all measurements is [0.29,

0.976], that is, 0.29 g/cm2≤ BMDUS ≤ 0.976g/cm2.

This User Guide will describe how the device should be used clinically in order to

obtain reliable, accurate, and precise measurements of an individual’s radial BMD. This

information, in conjunction with other risk factors, can enable a physician to assess an

individual’s risk of fracture as may occur in osteopenia and osteoporosis.

5. Basic Operation Overview

The operation of the UltraScan 650 device is relatively straightforward. In the

simplest terms, a forearm of a subject is placed between two ultrasound transducers,

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signals are propagated from one of the transducers (the source), through the forearm, and

to the other transducer (the receiver). The signals received are then sent to a laptop

computer to which the UltraScan 650 is connected, and processed, using its NTD®

technology (U.S. Patent No. 7,862,510) to obtain a set of ultrasound parameters that

provide information on the characteristics of the radius at the measured anatomical site.

This in turn, as noted, is related to the strength of bone and to an individual’s risk of

fracture. Once a subject’s forearm is placed between the two transducers, the test takes

about 10 seconds.

In order to use the device for either patient measurement or quality control (as

described in the following two sections), it is necessary to connect the UltraScan 650 to

a desktop or as will be assumed because of its convenience, a laptop computer.

CyberLogic’s software (named “UltraScan.exe”, although the desktop shortcut is named

“UltraScan 650”) must be installed on the laptop computer in order to use the UltraScan

650; in the following it is assumed that this installation has already been completed. The

UltraScan 650 software is currently Version 2.8, R8.

6. Contraindications

The UltraScan 650 should not be used on skin with open wounds or signs of

trauma, bleeding, or infection.

7. Setup

The basic steps for preparing to use the UltraScan 650 and a laptop computer are:

1. Plug the AC adaptor that comes with the laptop into an electrical wall outlet

and the adaptor output cable into the laptop (this is not necessary if it is

preferred to operate the laptop from battery power alone).

2. Connect the laptop to the UltraScan 650 using the USB cable provided. Note that

if a longer cable is required, a USB cable of the desired length (up to 5 meters for

the specified USB 2.0 specification) can be purchased separately.

3. Turn on the UltraScan 650 by using the rocker power switch located at the back

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of the unit, the same side where the USB cable is connected.

4. Turn on the laptop computer and wait for it to boot up and display the

desktop icons.

6. Double-click on the “UltraScan 650” icon on the desktop. This starts the

UltraScan program and brings up the screen that allows the technician to make

measurements with the UltraScan 650 on an individual.

7. To safely terminate operation of the UltraScan 650, turn the rocker power switch

to off.

8. Frequently used instructions

8.1 Patient (“New”) Measurement

This section details the steps that must be taken in order to obtain reliable

ultrasound measurements and accurate and precise estimates of bone characteristics

associated with a given individual. It assumes that the

UltraScan 650 and laptop computer have been properly

connected and that both have been powered-up, as described

in the previous section. It also assumes that a daily quality

control (QC) test has been performed and passed (see Section

8.4). A brief narrative description of how the UltraScan 650

is used for patient measurement will first be provided,

before providing the required steps in bulleted fashion.

Because the site of interest is the 1/3 site on the

radius, it is first necessary to measure the length of the

forearm so that the site can be accurately located. This is

done using a cloth ruler (image at right) that was shipped with

the UltraScan 650; however, any ruler can be used, and

length should be in centimeters (this length is entered on the

Patient Data page – see below). The desired length is the

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length of the ulna0F

1 that is defined to be the distance between the elbow and the ulna

styloid (the “bump” at the outer surface of the wrists (with hands facing down). To make

this measurement, the patient can be seated at a table with the forearm bent so that the

elbow rests on the table, and with the forearm itself at right angle to the table surface.

The length (in centimeters) is read off the ruler at a point which is at the top of the ulna

styloid. This point can be located by palpating the wrist joint and making a

determination as to the ulna length. This length will be needed for the UltraScan

measurement, so it may be a good idea to jot it down immediately on a note pad;

alternatively, you can enter it directly into the Patient Data page (see below). Note that

the measurement of ulna length does not need to be done with the patient seated or

seated at a table. The main element is that the elbow is bent and the length of the ulna

from the elbow to the ulna styloid be measured in centimeters.

Once the ulna length has been determined, the subject should be seated in front of

a table upon which the UltraScan 650 is situated. Use the laptop’s mouse (or keypad or

touch screen, appropriate) to click on “New Measurement” which will bring up a data entry

page, into which a subject’s information is to be entered1F

2. The first image on the next

page shows the main page of the UltraScan program from which all the other selections

can be reached.

The page below the main page on the next page is the (patient) data entry page,

which must be completed before a measurement on a subject can be performed. The

items are all self-explanatory. Note the data entry box for ulna length.

1 Although we are measuring the radius bone, it is the length of the ulna that has been historically

used to locate the 1/3 location along the radius. In addition, while the length of the ulna can be

measured with a ruler, the radius length cannot.

2 Note that this assumes that a quality control test has been performed in the last 24 hours; if not the program

will not allow you to make a measurement on a patient. Please see the next section on conducting a daily

quality control test.

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If only the BMD, T- and z-scores are desired, only the section labeled

“T-score and z-score required info” needs to be filled out with correct data, plus

patient name of course. The “Body Data” section is still required, but any non-zero

data can be used. In addition, the “Note for patient” is also optional. Note also the

Measurement Site box; it is important that the appropriate item be checked (i.e., left or

right forearm). Once the required data has been entered, click on the “Test” button.

The patient’s forearm must then be positioned between the transducers. To do this,

the patient should be seated in front of the machine. Note that the UltraScan 650 can

measure either the left or right forearms (radii). In either case, the inner part of the

measured forearm will be in contact with the small circular ultrasound transducer.

Once the subject has been seated and the forearm chosen for measurement

(typically the non-dominant arm should be used), it is necessary to place the forearm into

the device.

To do this, the ulna position locator (UPL) must first be placed (using its pair of

pins) into a pair of holes in the base of the unit that are located along the scale at the same

value as the ulna length (see picture below; the UPL in this image is placed in the position

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for a subject with an ulna length of 27 cm).

Note that the UPL comes in two thicknesses; generally, except for the smallest

forearms, the thinner UPL should be used. The one used should be the one that aligns the

top of the forearm (at the 1/3 location) approximately at the same height as the top of the

large rectangular transducer. Once this UPL has been selected, it should be situated so that

the front edge of the UPL is at the patient’s arm length on the scale on the base of the unit, as

noted above. A hand positioning locator (HPL) must be placed on the UPL, so that the

patient can maintain a consistent position and orientation of the hand/forearm. The subject

should hold the HPL loosely with little or no force. Also, place an elbow rest foam (ERF),

not shown, so that the forearm is maintained approximately horizontal with the base of

the UltraScan 650. Once the UPL and ERF are in place, the subject’s arm is ready to be

placed into the unit. The moveable transducer should be opened completely – by pulling

out the transducer slide handle (TSH). Then place the arm into the unit so that ulna styloid

rests firmly against the rod of the UPL and that the elbow rests on the ERF, and the

forearm rests lightly against the circular transducer (see figures below).

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Before closing the transducer down on the forearm, an ample amount of 70%

isopropyl alcohol should be sprayed (with the supplied alcohol spray bottle) on both the

rectangular and circular transducers’ active faces (you may have to move the arm away to do

this) and also spray the alcohol on both sides of the forearm against which the transducers

will press upon. Once an ample amount of alcohol has been sprayed on all contacting

surfaces, push the TSH so that the large rectangular transducer closes down on the arm and

make sure that at the same time the inner part of the patient’s arm is pressing firmly against

the small circular transducer (the operator should use a hand to make sure that the inner part

of the forearm is pressed against the small transducer as the large rectangular transducer

presses down on the other side of the forearm. Press the TSH with sufficient force so that the

red-colored groove just disappears inside the slide (this ensures that 3 pounds of force are

exerted against the patient’s forearm) and lock the transducer with the slide lock lever (see

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pictures above). In the picture directly above, the transducer slide lock is in the “locked”

position, and the patient’s arm is held firmly between the two transducers.

The UltraScan 650 is now ready to make a measurement. On the Ultrasound Data

Acquisition window showing on the screen, click on the Start button (see image below).

Note that the window also displays the status of the battery within the UltraScan 650, as

well as an opportunity to cancel the measurement.

Note that there is a battery inside the UltraScan 650. The battery is not

removable by the user and is recharged by the laptop USB port. However, the

charging occurs only when the UltraScan 650 switch is set to “Charge” (bottom

position). The switch can be moved to Charge (during which the battery is charging)

at any time; note however that the UltraScan cannot make a measurement in the

Charge position. With the switch in the Charge position, if the battery is charging, a

red light will appear next to the Charge label; when the battery is fully charged, the

light will change to green. Generally, the unit can be charged overnight so that the

battery will be fully charged in the morning. However, in those situations with severe

usage) say 100 measurements per day or more, it will be a good idea to switch to

Charge between measurements, at lunchtime, or other breaks so that the battery will

remain at full or near-full charge. The picture on the next page shows the switch, the

Charge, Off, and On labels, and the USB port with a cable attached; in the picture the

switch is in the Charge (lower) position, and the green light indicates that the battery

is fully charged. When neither charging nor using the device for measurements, the

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switch can be placed in the Off (center) position.

Once the Start button is clicked, the UltraScan 650 will then wait a

predetermined amount of time (2 seconds) and then transmit ultrasound energy through

the forearm in about 7 more seconds (for a total time of a little less than 10 seconds) the

unit will stop emitting ultrasound, the program will prompt the technician to unlock the

transducer and remove the arm from the UltraScan 650. Once OK is clicked, the small

transducer will reposition itself downwards ready to perform another test. The test has been

completed. All the test information on the subject including BMD will be shown in the

Patient Info and Test Result areas on the computer screen (shown on next page). Note

that the patient’s BMD in grams per square centimeter, as well as a T-score and a z-

score are provided. Note also that two NTD parameters from which the BMD is

computed are also provided. The graph shows the patients BMD with respect to the

average for the patient’s age and sex, and for ethnic/racial group if available. If a

specific ethnic /racial group is not available, the UltraScan software defaults to White.

This page may be printed and given to the patient and/or sent to the referring physician

for follow-up. Note that printing to a pdf file is often the most suitable print option.

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The steps in outline form for measuring a subject with the UltraScan 650 are as

follows (this assumes that a daily QC test has passed; see Section 8.4):

1. Measure the subject’s arm to obtain the ulna length and place the appropriate

UPL and ERF at their correct respective locations on the base of the unit.

2. Select New Measurement and enter the patient’s info into the data entry page

and click on “Test”.

3. Place the subject’s arm onto the UPL and ERF so that the ulna styloid rests firmly

against the rod of the UPL, spray with ample alcohol on all surfaces (transducer

active surfaces and skin over which transducers will come in contact with), and close

the transducer down onto arm with sufficient force (making sure that the inner

side of the forearm is pressing firmly against the small round transducer), and

lock the transducer with the locking lever.

4. Click on the Start button on the screen; the unit will then count down a few

seconds and then begin testing by measuring ultrasound signals that have

propagated through the patient’s forearm. After less than 10 seconds the test is

completed, and the program will prompt the tech to unlock the transducer and

remove the patient’s arm from the device. By clicking on OK, the program will

display the patient’s BMD and other data on the screen.

Note that pressing F1 at any dialog or window will bring up context sensitive Help.

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8.2 Review Measurement

This section details the steps that must be taken in order to review patient

measurements that were obtained previously. Data obtained using the Patient

Measurement procedure is saved in a file with a filename that includes the patient’s name

and date and time of the measurement (the name also includes an “R” or and “L”

indicating a right or left forearm measurement, respectively). Therefore, it is possible to

review any of these previously acquired measurements. The processing is identical to that

which is carried out in a standard patient measurement procedure that is initiated via the

“New Measurement” button.

To review previously collected data, simply click on the “Review Measurement”

button. This will bring up a standard file selection window that shows the filenames which

are available to select; scroll to the desired file, click on it to highlight it, and then click on

“Open.” This will cause the program to load the data contained in the file and process it; it

will display the patient information and test results (ultrasound/bone data) exactly in the

same way as is done in a “New Measurement” procedure and is fully described in the

Patient Measurement section of the User Guide. Note that in the file selection dialog, the

user can use a filter to list specific patients, for example all patients whose last name begins

with “S” and who have binary data files associated with them; to do this choose filter: (S)

Binary files (s*.umb). In this case, only patient names that start with S and for whom binay

files exist will be listed. The filter is easy to use and is very convenient, especially, when

there are a lot of patient data files.

Finally, note that the Review Measurement option may be particularly useful

when a subject has been measured over a period of time, for example. The test data

may then be printed out (see section on Print Report) for several time points to

determine the degree of change in bone properties that may have occurred.

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8.3 Print Result

The “Print Result” button allows for a hard copy of the test results to be produced.

This can be used for archival reference in the patient’s file, to give a copy to the

patient, or to send a copy to the referring physician, together, for example, with a

report. The hard copy report reproduces the information on the laptop’s screen that is

displayed once a test has been successfully completed, or after the Review

Measurement procedure has been completed. The hard copy report will also display

the name and address of the institution which has carried out the test (e.g., “Bone

Density Testing Solution, Inc., Anywhere Street, Somewhere, USA). Note that for a

hard copy to be generated, a printer would need to be connected the laptop computer.

Note that this option can also be used to generate a PDF file version of the

report, which is convenient in case the referring physician may want to receive the

report by e-mail. To use this option, after clicking on “Print Result,” select the pdf

file “printer” and enter a file name for the report; this will save the report that can

then subsequently be printed, e-mailed, archived, etc.

8.4 Quality Control

In order to ensure the accuracy and precision of the UltraScan 650 bone assessment

device, a quality control test is required to be run once a day. No test can be performed on

any subject on a given day if the quality control test has not been carried out first and the

data “passed.” A day is to be understood to mean the 24 hour period between two

successive midnights.

A quality control block (QCB), composed of Lexan 9440, that was shipped with the

machine is used to perform the daily quality control test. When the UltraScan 650 is

turned on in a period for which the quality control test has not yet been performed and

passed, the program will prompt the technician/user whether or not to perform a quality

control test. Clicking “Yes” will allow the technician to carry out the quality control test.

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Note that no patient testing can be carried out unless a quality control test has been

done and passed within the day time period. On clicking Yes, to perform a quality

control test, the program will prompt the tech to add gel and the QC block (see screen on

next page) and close the transducer in and lock it to secure the QCB between the two

transducers, and then click on Yes when ready. A data acquisition window will then be

shown, and the QC test will start automatically in a few seconds. The program will then

prompt the user to unlock the transducers and remove the QCB. Upon clicking on OK to

indicate that this has been done, the program will report either a successful (“pass”) test

or a unsuccessful (“test fail”). If successful, the UltraScan can then be used for patient

testing; if not, another QC test should be attempted. See “Troubleshooting” for help with

failed QC tests.

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The steps required to perform a quality control test are:

1. Click “Yes” the quality control test prompt on the laptop.

2. Place ultrasonic gel onto the two transducer surfaces; for the rectangular

transducer, only the bottom portion of the transducer needs gel.

3. Place the QCB between the two transducers and close the transducer slide down

against the block so that it pushes against the small round transducer and lock the

transducer slide. Note that it does not matter which face of the QCB is measured

for quality control.

4. Click on Yes to continue with QC test. An “Ultrasound Data Acquisition” window

will appear and the test will run automatically in a few seconds. The UltraScan 650

will compare the QC test data with data stored at the factory when the UltraScan 650

was shipped.

5. If the test fails, repeat it a number of times and if still unsuccessful, the user should

check the battery level. (Remember that the battery level can be monitored whenever the

Ultrasound Data Acquisition window appears before the QC test begins.) If the battery level

is “Low”, charge the battery and then try again. Contact CyberLogic for support

(support@cyberlogic.org or 212-260-1351) if still unable to achieve a QC test pass.

If the test passes, patient data may be collected until midnight of that day.

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8.5 Reference

The Reference pull-down menu allows the user to select an appropriate normative

database to be used for comparison of the present patient and for generation of z- and

T-scores; however the normative database is selected automatically by the program.

The ultrasound net time delay parameters and bone mineral density (BMD) estimates

generated from a given test are always valid independent of which reference file is

used; however, comparisons for z- and T-score generation may not be valid unless an

appropriate normative database is available. At present, normative databases, based

on Hologic’s normative DXA databases for radius BMD, are available for adult white

and Asian females and males.

9. Troubleshooting

There are a number of issues that may arise during the operation of the UltraScan

650. In this section, some of these problems are described together with

possible solutions.

The laptop program keeps saying that it cannot communicate with the UltraScan 650?

Make sure that the laptop is connected to the UltraScan 650 via a USB cable. Also,

make sure that power switch on the UltraScan 650 is turned to On (upward

position). Try closing and restarting the program on the laptop in order to

communicate with the UltraScan 650. Also, make sure that you aren’t trying to run

more than one instance of the program; the same message will show if you do. If the

laptop is still unable to communicate with the device, please contact CyberLogic for

assistance.

The quality control test keeps failing.

The quality control test has very stringent criteria for passing. Please make sure that

the plastic block does not have any dried gel on its test surfaces; wash it off before

using if necessary. This applies to the transducer surfaces as well; spray some alcohol

on the surfaces and wipe off any dried gel there as well. Also, make sure there is

sufficient new gel on the transducer surfaces. Make sure that the transducer is closed

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down firmly on the test block. If the quality control test continues to fail after several

tries, please note the message accompanying the test failure notification on the laptop

(printscreen may be helpful here), and contact CyberLogic for further assistance.

The patient tests often result in errors.

There are several reasons why the patient test can be reported as having an error

occurred. The two main reasons why this may happen are that the arm is not in the

correct location, and that insufficient wetting agent (alcohol in the spray bottle) has

been applied to the transducers and/or to the patient’s arm. If an arm is placed in the

wrong location (i.e., not at the 1/3rd

site), the received signals may not be able to be

processed correctly. If insufficient alcohol has been used, the acoustic coupling

between the transducer surfaces and skin may be poor resulting in poor signal-to-

noise ratio. If an error occurs, the test should be redone after the arm has been

carefully repositioned (and perhaps re-measured) and fully wetted (including the

transducer faces) with the spray-bottle containing alcohol. Another possible reason

for test failure is that the transducer has not been fully closed so that it is pressing

firmly onto the patient’s arm, and that the inner portion of the patient’s arm is pressing

firmly against the small circular transducer. It is also important that the patient remain

as still as possible for the duration of the test. If subject test failures occur more than

relatively rarely, please contact CyberLogic for additional assistance.

It may also be the case that after making a measurement and unlocking/opening the

transducers and removing the arm and clicking on Ok, that no data appears in the

Result Information portion of the Bone Data page. This means that for some reason

the BMD was not able to be computed. In this case, a new measurement will be

prompted to be made. Before making a new measurement, ensure that ample alcohol

is sprayed, careful attention is given to forearm positioning, the correct ulna position

locator is used, the hand position accessory is in place, and that the transducers are

firmly in contact with the forearm and locked. If the test fails several times on a given

patient, it may not be possible to complete a successful BMD test on this individual.

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Note that there is an option for unchecking the box “Standard Mode” on the main

screen window. This will also bring up a box marked Time Delay Plot, that can be checked.

If this box is checked, each measurement will bring up a Time delay Plot dialog box that is

useful for assessing what issues there may be for subjects for whom there are problems with

the test. The image below shows one such case. Note that there is also a “LED” at the

bottom of the dialog box. A green LED means the data is perfectly fine and should be

accepted. A yellow LED means that there are some issues and leaves it to the tech to decide

whether to Accept or Exclude the data; if the Continue button is clicked, the data will be

excluded in the case of a yellow but the file extension will not be renamed. If the LED is

red, this indicates serious problems with the data, and this data will always be excluded by

the program. Note that excluded data files still exist in the data folder, and it may be useful

to email such files to CyberLogic for further analysis.

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10. Error codes

The following describes the various error codes that may occur:

1. Unable to open the Reference file: This indicates that a reference BMD file for a

specific sex and ethnicity is not able to be loaded by the Forearm program. In this case, a

BMD value will still be provided as output, but a T- and z-score will not be given. Contact

the manufacturer to determine if additional BMD reference files are available.

2. Quality Control Failed:The QC measurements did not result in a successful QC. In

order to perform new measurements, a successful QC test must be completed within 24

hours of the previous QC test. If QC fails, re-test by using sufficient gel and making sure

that the block is correctly positioned between the transducers. If a successful QC cannot be

completed after multiple tries, contact the manufacturer.

3. The standard deviation of the measurements is higher than usual: The data

appears to be noisier (i.e., higher standard deviation) than is typical. The technician should

repeat the measurement, taking extra care to ensure that ample alcohol has been sprayed on

the faces of both transducers, as well as on the both sides of the forearm to be measured. In

addition, make sure that the transducers are positioned and locked on the forearm firmly. If

the problem persists on more than one patient, contact the manufacturer.

4. Unable to communicate with UltraScan 650: The UltraScan program is not able to

communicate with the UltraScan 650. Make sure that the UltraScan 650 power switch is in

the “On” position, and that the USB cable is attached to the laptop computer and to the

UltraScan 650. If the problem persists, reboot the laptop. If the problem cannot be corrected

by these methods, contact the manufacturer.

5. Incorrect serial number: The serial number of the UltraScan 650 does not match

the serial number stored on the PC. This indicates that a different scanner is being used than

was initially setup, or that the serial number of the UltraScan 650 is corrupted. Contact the

manufacturer.

CyberLogic, Inc.

11. Device Characteristics

The UltraScan 650 (shown at right) is a proprietary device and includes a proprietary

program (“UltraScan”) that communicates with it from a

standard laptop computer over a USB interface. The

device, which is 15 inches wide, 12 inches deep, 7 inches

high, and approximately 8 pounds in weight, emits

ultrasound waves from a source transducer that propagate

through an individual’s forearm to a receiver transducer.

Custom electronics serve to generate the ultrasound signal,

and to digitize and average the data. The laptop through

the UltraScan software collects the data from the device,

and processes it using CyberLogic’s patented NTD® signal

processing technology, to obtain two NTD parameters.

These parameters are then used to calculate BMDUS, an

estimate of the bone mineral density (BMD) at the 1/3 radius that would be obtained at the

same site with DXA.

The UltraScan 650 shown at right with

a forearm positioned for measurement is an

ultrasound thru-transmission quantitative

ultrasound bone sonometer device designed

to estimate the bone mineral density (BMD)

of the radius bone at the 1/3 location. It

processes ultrasound signals after

propagating through a forearm and outputs

an estimate of BMD as would be measured by dual energy x-ray absorptiometry (DXA).

The device is constructed around a 1 cm x 4.8 cm rectangular single element source

transducer and a 3 mm x 1.5 mm rectangular single element receiver transducer, and both

transducers are flat (unfocussed). The device, connected to a laptop computer via USB,

emits a broadband ultrasound signal nominally at 3.5 MHz from the source that propagates

through the radius and soft tissue to the receiver. In water, the received waveform has a

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nominal center frequency of 3 MHz with a 3 dB bandwidth of 800 kHz. In operation, the

source emits a broadband ultrasonic pulse at a rate of 1 kHz, the receiver waveforms are

sampled at a 50 MHz sampling rate. The signals are summed to obtain an averaged set of

about sixty-four received waveforms. The averaged waveforms are then processed to obtain

two ultrasound net time delay (NTD) parameters, NTDDW and NTDCW, each in units of

microseconds. NTDDW, the DW notating “direct wave”, is defined as the difference

between the transit time of an ultrasound pulse through soft-tissue, cortex and medullary

cavity, and the transit time through soft tissue only of equal overall distance. NTDCW, the

CW denoting “circumferential wave”, is defined as the difference between the transit time

of an ultrasound pulse through soft-tissue and cortex only, and the transit time through soft

tissue only again of equal overall distance. Measurement of the two NTDs on an individual

takes about fifteen (15) seconds, with no operator post-processing necessary. An ultrasound

based estimate of radial BMD, BMDUS, in units of g/cm2, is then obtained according to the

following formula:

BMDUS = a · [ NTDCW • NTDDW ]1/2 + b

In this key equation, a and b are regression parameters that have been determined by the

method of least squares, using clinical measurements on study subjects for whom the

ultrasonic NTDs and BMD as determined by DXA were both determined; a = 0.19

g/cm2/µs and b = 0.28 g/cm2. The precision of the estimate is 2.1%.

CyberLogic, Inc.

12. Accessories / Consumables

12.1 Accessories

The UltraScan 650 comes with four (4) key categories of accessories. They are:

(i) The length of the ulna is required to ensure

that the 1/3 location of the radius is

measured. For this, a cloth ruler or tape

measure is shipped with the UltraScan 650.

However, any ruler may be used. As shown

in the image at right, the ruler is used to

measure the ulna length from the elbow to

the ulna styloid.

(ii) The ulna position locator (UPL) (see figure on next page) is used to ensure that

the ultrasound measurement is performed at the 1/3 location (US Patent No.

9,039,616). The UPL, as shown in the figure at right attached to the base of the

UltraScan 650, is a Lexan 9440 block with an attached Lexan 9440 rod. The

UPL is placed at a position corresponding to 1/3 of the forearm length that was

measured with the cloth ruler of (i). The UPL is supplied in two thicknesses,

0.177 inch and 0.5 inch; the two thicknesses are used to accommodate very

slender forearms (which might need the thicker UPL) to average and larger

forearms (which will generally need the thinner UPL). The objective is to have

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the upper surface of the arm approximately aligned or somewhat below the

upper edge of the large rectangular transducer. The majority of subjects can be

measured with the 0.177 inch thick UPL. A detailed drawing is shown below for

the UPLs. Note that each UPL has a pair of stainless steel pins that insert into a

matching pair of holes in the UltraScan 650 base; the specific set of holes used

for a particular subject depend on his or her forearm length and ensure that the

measurement of the radius occurs at the 1/3 location. On the top of the next page

is an arm positioned in the UltraScan 650 with the ulna styloid pressed against

the UPL rod.

CyberLogic, Inc.

(iii) A hand positioning accessory is used to ensure that the arm/hand are positioned

the same way for each measurement. The hand positioning accessory is a plastic

tube around which the patient loosely wraps the hand around. This ensures that

there is no rotation of the forearm/radius from one measurement to the next. The

images below show the hand positioning accessory and a forearm positioned in

the UltraScan 650 with a hand wrapped around the hand positioning accessory.

Note the position of the thumb.

CyberLogic, Inc.

(iv) A quality control block (QCB) is used to perform the required quality control

test daily. The QCB is composed of Lexan 9440, and is a cuboid with each side

being 1.5 inch. A picture is shown below with the QCB in the UltraScan 650.

Each UltraScan 650 comes with a QCB, but the QCBs are largely

interchangeable. Not apparent in the image but there is a liberal amount of gel

between each transducer and the QCB. Note that the QCB can be measured in

any orientation.

CyberLogic, Inc.

12.2 Consumables

Over the counter Isopropyl alcohol (70%) is necessary for insuring good contact

between the arm and the ultrasonic transducer. Any non-toxic plastic spray bottle can be

utilized for this application of the alcohol to the arm and transducer faces (one full spray

bottle is shipped with the unit for convenience).

Over the counter ultrasonic gel is necessary for performing the Quality Control

procedure (One bottle of gel is shipped with each unit for convenience).

13. Performance Results Summary

The UltraScan 650 forearm scanner is an ultrasound-based device designed

to quantitatively measure the BMD of the radius bone at the 1/3 location, shown

in the figure below with a person/forearm positioned for measurement. This

anatomical site has been measured with x-rays for decades and has been shown to

be a convenient site for reliable estimation of bone loss and bone fracture risk. The

UltraScan 650 makes each radiation-free measurement in about ten (10) seconds,

with a reproducibility of 2.1 percent. The UltraScan 650 should allow for much

wider diagnosis and detection of individuals at risk of osteoporotic fracture. The UltraScan 650 is a through-transmission system that has a single-

element moving t ransducer with a single element source, operating at 3.5

MHz. The system is designed to measure the radius at the 1/3 location (shown as

the radius and ulna ( f i g u r e b e l o w l e f t ) and the cross-section of the

radius ( f i g u r e b e l o w r i g h t ), a site that has been measured for decades

with x-ray densitometers.

CyberLogic has conducted numerous studies on the ability of the UltraScan™ 650

device and technology to reliably and accurately estimate radial BMD as determined by

DXA. These studies have included computer simulations, in vitro experiments, and clinical

data. In each and every case, correlation with BMD has been greater than 0.9. The

underlying principal of the UltraScan™ 650 is the measurement of three ultrasound signals

that have propagated in distinct pathways through the forearm. One signal is associated

with propagation through soft tissue only, as exists between the ulna and radius (the “soft-

tissue wave” or SW). Another signal is one that has propagated through the soft tissue

overlying the radius and within the radial cortical shell only (the “circumferential wave” or

CW). The third signal is one that has propagated through the overlying soft tissue, through

the radial cortex, and also through the radial medullary cavity (the “direct wave” or DW).

The measurement of the travel times associated with these three signals and the formation

of two (2) net time delay (“NTD”) parameters (by subtracting the travel times of the CW

and DW from the travel time of the SW, respectively) forms the basis of the UltraScan®

650 technology. As noted previously, the estimate of BMD is formed by an affine

relationship between BMD on the one hand, and the square root of the product of the two

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NTDs, on the other:

BMDUS = a · [NTDCW • NTDDW]1/2 + b

In a computational (simulation) study on 20 human radii, NTDDW was shown to have a

high correlation (r = 0.99, P<0.001) with cortical thickness. The data from this simulation

study also showed that BMD was highly correlated with the ultrasound estimate of BMD

(i.e., Eq. 1), namely a correlation of r = 0.96, P<0.001.

An in vitro study on the same set (less one) of human radii was also carried out. The

radii were scanned in a water tank with a laboratory prototype similar to the clinical

UltraScan™ 650. The two NTD parameters were evaluated and shown to have a correlation

(r = 0.95, P<0.001) with the cross-sectional (bone) area. This data was further analyzed and

an ultrasound estimate based on Eq. 1, was again found to be highly correlated with BMD,

namely r = 0.92, P<0.001.

Two clinical studies also have been completed. One at a large teaching hospital

involved the use of 78 study subjects and correlated the ultrasound data with BMD as

determined by forearm DXA. The correlation obtained was r = 0.93, P<0.001.

The other clinical study at a private radiology practice involved the use of nine (9) study

subjects who had multiple measurements along one or both forearms in order to determine

the ability of ultrasound to estimate BMD at various positions along the forearms. In this

case, a total of one-hundred eleven (111) measurements along the forearms showed a high

correlation with DXA BMD measured at the same locations along the forearms (r = 0.93,

P<0.001). Reproducibility of the UltraScan™ 650 in terms of estimated BMD was found to

be 2.1 percent.

The publications referred to above and other related ones are listed here (see our

website for an up-to-date summary of publications and other information on the

UltraScan 650 (www.cyberlogic.org).:

• Siffert RS, Kaufman JJ. Ultrasonic Bone Assessment: 'The Time Has Come’ Bone,

40: 5-8, 2007.

• Kaufman JJ, Luo GM, Siffert RS. A Portable Real-Time Bone Densitometer,

Ultrasound in Medicine and Biology 33(9):1445-52, 2007.

CyberLogic, Inc.

• Le Floch V, McMahon DJ, Luo GM, Cohen A, Kaufman JJ, Shane E, Siffert RS.

Ultrasound Simulation in the Distal Radius Using Clinical High-Resolution

Peripheral-CT Images. Ultrasound in Medicine and Biology, 34(8):1317-26, 2008.

• Kaufman JJ, Luo GM, Siffert RS. Ultrasound Simulation in Bone (Invited Paper).

IEEE Transactions Ultrasonics, Ferroelectrics and Frequency Control 56(6):1205-

1218, 2008.

• Krieg MA, Barkmann R, Gonnelli S, Stewart A, Bauer DC, Del Rio Barquero L,

Kaufman JJ, Lorenc R, Miller PD, Olszynski WP, Poiana C, Schott AM, Lewiecki

EM, Hans D. Quantitative Ultrasound in the Management of Osteoporosis: The

2007 ISCD Official Positions. Journal of Clinical Densitometry 11(1):163-187,

2008.

• Le Floch V, Luo GM, Kaufman JJ, Siffert RS. Ultrasonic Assessment of the Radius

in Vitro. Ultrasound in Medicine and Biology 34(12):1972-1979, 2008.

• Kaufman JJ, Luo GM, Siffert RS, Effect of Arm Dominance on Quantitative

Transmission Ultrasound at the Forearm (Abstract) J Bone Miner Res 24(S1):S319,

2009.

• Kaufman JJ, Luo GM, Blazy B, Siffert RS. Quantitative Ultrasound Assessment of

Tubes and Rods: Comparison of Empirical and Computational Results. Acoustical

Imaging, Volume 29, Proceedings of the 29th International Symposium on

Acoustical Imaging, Springer: New York, pp. 467-472, 2009.

• Kaufman JJ, Luo GM, Lieberman M, Rosenfeld S, Rosenbaum A, Siffert RS.

Ultrasonic Assessment of the Radius (Abstract) J Bone Miner Res 25(S1): S313,

2010.

• Kaufman JJ, Luo GM, Liu X, Rosete F, Chen P, Kamanda-Kosseh M, McMahon

DJ, Stein E, Shane E, Siffert RS. Ultrasonic Assessment of the Ultra-Distal Radius

(Abstract) J Bone Miner Res 26(S1): S313, 2010.

• Luo GM and Kaufman JJ. Ultrasonic Bone Assessment Apparatus and Method,

United States Patent Number 7,862,510, Issued January 4, 2011.

• Stein E, Rosete F Liu X, Young P, Kamanda-Kosseh M, McMahon DJ, Luo GM,

Kaufman JJ, Shane E, Siffert RS. Ultrasonic Assessment of the Ultra-Distal Radius

J Bone Miner Res 26 (Suppl 1) 2012 Available at:

http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=c977c52f-

d748-41e0-9925-6100c774d111 Accessed March 18, 2013.

• Nagaki GM, M Lieberman, GM Luo, JJ Kaufman, S Rosenfeld, A Rosenbaum and

RS Siffert. The Axial Dependence of Bone Density and Ultrasound at the Radius,

Journal of Clinical Densitometry 15(4):492-493, 2012.

CyberLogic, Inc.

• EM Stein, F Rosete, P Young, M Kamanda-Kosseh, DJ McMahon, GM Luo, JJ

Kaufman, E Shane, RS Siffert. Clinical Assessment of the 1/3rd Radius Using a

New Desktop Ultrasonic Bone Densitometer. J Bone Miner Res 27 (Suppl 1) 2012

Available at:

http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=85d3786d

-451e-4fa4-8d76-296b4a61c22e Accessed March 18, 2013.

• Kaufman JJ, Luo GM, Siffert RS. 3D Simulation of Ultrasound in the Ultra-distal

Human Radius, in Acoustical Imaging, Volume 31, Nowicki A, Litniewski J,

Kujawska T, Eds., Springer: New York, pp. 39-43, 2012.

• Luo GM and Kaufman JJ. Ultrasonic Bone Assessment Apparatus and Method,

United States Patent Number 8,202,219, Issued June 19, 2012.

• EM Stein, F Rosete, P Young, M Kamanda-Kosseh, DJ McMahon, GM Luo, JJ

Kaufman, E Shane, RS Siffert. Clinical assessment of the 1/3 radius using a new

desktop ultrasonic bone densitometer. Ultrasound in Medicine and Biology

39(3):388–395, 2013.

• Kaufman JJ, Luo GM, Rosete F, Bucovsky M, Stein EM, Shane E, Siffert RS. 2014

Ultrasonic Assessment of the Radius (Invited Paper), in Proceedings IFMBE, 2014,

VV Toi, THL Phuong, eds., Vietnam National Universities, Ho Chi Minh City,

Vietnam, pp. 77-79.

• Stein E, Rosete F, Luo GM, Bucovsky M,Kaufman JJ, Shane E, Sifffert. 2014

Clinical Ultrasonic Bone Assessment of the 1/3 Radius, ASBMR 2014 Annual

Meeting, Houston, TX.

• Kaufman JJ, Stein E, Luo GM,Rosette F, Schechner Z, Bucovsky M, Shane E,

Siffert RS (2014) Clinical Ultrasonic Assessment at the 1/3 Radius, Proceedings

2014 IEEE International Ultrasonics Symposium, Chicago, Il.

14. Device Operation/Safety

The UltraScan 650 is similar to several ultrasonic bone assessment devices, that use a

single element source transducer operating in through transmission mode. Two such

devices are the GE/Lunar Achilles Express http://www.gehealthcare.com/euen/bone-

densitometry/products/peripheral/achilles-exp/index.html (shown below)

CyberLogic, Inc.

and the Hologic Sahara http://www.hologic.com/skeletal/osteoporosis-

assessment/sonometer/ (shown below).

CyberLogic, Inc.

In these two devices, an ultrasound waveform is emitted from a large single element

transducer, passes through the heel, and is received by another transducer on the other

side of the heel. The UltraScan 650 is similar in that ultrasound passes thru a bone in the

body except that instead of the heel, the forearm is placed between the transducers.

However, the UltraScan 650 is distinct in that it determines, unlike other bone

sonometers, the bone mineral density (BMD) of the bone. Other ultrasound devices

generally measure only ultrasound parameters such as SOS and BUA, and these

parameters are not well correlated with BMD nor with osteoporotic fracture risk.

Statistical maximum values of acoustic power levels are well within FDA safety

levels (as shown in the Table below).

Use ISPTA.3(mW/cm

2)

ISPPA.3(W/c

m2)

MI

FDA safety limits

(Fetal Imaging and Other,

i.e. Bone Sonometer)

94 190 1.9

UltraScan 650 6.93 4.46 0.143

Measurement uncertainties are as follows: Power ±16.5% Pressure ±8% Intensity ±16.5% Center frequency ±2%

For the UltraScan 650, the center frequency is 3.5 MHz, with a pulse length of 0.5

microseconds, and a pulse repetition frequency of 1 kHz. Each measurement sequence

involves transmitting 64 pulses and averaging the 64 received signals. Each test involves

repeating each measurement sequence 1-5 times. ISPTA.3, measured with a calibrated

hydrophone at a depth of 2.3 cm, is 0.63 mW/cm2

, and ISPPA.3 is 1.2 W/cm2

. Total

exposure time at these intensity levels for the entire test (consisting of 1-5 repeat

measurements) is less than 60 seconds. The data from each of the 1-5 measurements is

processed in the laptop to obtain two net time-delay (NTD) parameters, which are in turn

averaged using the 1-5 measurements. The number of such measurements (i.e., 1, 2 3, 4

or 5) depends on the variations observed. Data shows that 1 measurement produces about

the same precision and accuracy as multiple measurements.

CyberLogic, Inc.

The UltraScan 650 has an electrical circuit board that produces a pulse that is applied

to the source transducer which is in contact with the skin on the forearm of a subject.

This in turn produces an ultrasound pulse that propagates through the forearm, where it

emerges at the other side and detected by a receiver, also in contact with the skin of the

subject’s forearm. Isopropyl alcohol (70%) is sprayed onto the skin and transducers in

order to ensure good acoustic coupling. The alcohol also is used to disinfect the

transducers between study subjects.

The data at the receiving transducer is sampled and digitized with another circuit

board, and transferred via USB to a laptop. All electrical connections of the UltraScan

650 are electrically isolated.

15. Calibration and maintenance

15.1 Cleaning

The UltraScan 650 should be wiped down with a non-abrasive clean cloth and

isopropyl alcohol (70%) after each use.

15.2 Calibration

Section 7.4 describes the daily quality control procedure. No other calibration is

required.

CyberLogic, Inc.

16. Specifications / Regulatory statement

CyberLogic UltraScan 650 weight - 8 pounds

CyberLogic UltraScan 650 size - 15" wide x 10" deep x 7" high

Allowable Operating Temperature - 60°F to 90°F (15.5°C to 32.2°C)

Allowable Operating relative humidity - 10% to 90% RH (non-condensing)

Power input CyberLogic Power Supply- None

Power input CyberLogic UltraScan 650 - USB Powered

This product complies with the electromechanical safety requirements of the

following standards:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for

Basic Safety and Essential Performance, 2012

This product meets or exceeds the requirements of Electromagnetic Compatibility

(EMC), pursuant to the Collateral Standard, IEC 60601-1-2 2nd edition, which addresses

EMC in North America, Europe and other global communities. This includes

demonstrated immunity to radio frequency electric fields at a level of 10 volts/meter from

150 kHz through 2.5 GHz, and 15 kV for Electrostatic Discharge (ESD), in addition to

the other requirements of this standard as applicable.

Compliance to EMC standards does not ensure that a product has total immunity; an

event of sufficient magnitude, or a sufficiently powerful transmitter in close proximity

will be a substantial threat to any medical device or electronic system.

Certain devices (such as cellular phones, two-way radios and pagers, PDAs, cordless

phones, paging systems, electronic games, etc.) emit radio frequency energy that could

interrupt operation if located too close to a medical device. Frequency, field strength and

mode of operation make it difficult to determine at what point these devices may present

a threat or cause interference. Radio frequency emissions may be additive.

Practitioners should be aware of these concerns. It is recommended that an operating

policy be established in the health care facility to ensure proper separation or control of

such devices. Consult with the Biomedical Engineering Department of your institution in

case of suspected susceptibility or interrupted operation.

CyberLogic, Inc.

Table 201: Guidance and Manufacturer’s Declaration -

Emissions

This product is intended for use in the electromagnetic

environment specified below. The clinical user should ensure

that it is used in such an environment.

Emissions Test Compliance

Electromagnetic Environment

- Guidance

CISPR 11

RF Radiated Emissions Class A

This product uses RF energy only for its

internal function. Therefore, its RF

emissions are very low and are not likely

to cause any interference in nearby

electronic equipment.

CISPR 11

RF Conducted

Emissions

Class A

This product is suitable for use in all

establishments, including domestic

establishments and those directly

connected to the public low-voltage

power supply network that supplies

buildings used for domestic

purposes.

IEC 61000-3-2

Harmonic Emissions Class A

IEC 61000-3-3

Voltage Fluctuations,

Flicker Emissions

Complies

CyberLogic, Inc.

Table 202: Guidance and Manufacturer’s Declaration –Immunity

This product is intended for use in the electromagnetic environment

specified below. The clinical user should ensure that it is used in such an

environment.

Immunity

Test

IEC 60601-1-2 Test

Level

Compliance

Level

Electromagnetic

Environment -

Guidance

IEC 61000-4-2

Electrostatic

Discharge (ESD)

Conductive Surfaces

±2kV

±4kV

±6kV

Non-Conductive Surfaces

±2kV

±4kV

±8kV

Conductive Surfaces,

contact discharge

±2kV

±4kV

±6kV

Coupling Planes,

contact discharge

±2kV

±4kV

±6kV

Non-Conductive

Surfaces,

air discharge

±2kV

±4kV

±8kV

Floors should be wood,

concrete, or ceramic tile. If

floors are synthetic, the RH

should be at least 30%.

IEC 61000-4-4

Electrical Fast

Transient/Burst

(EFT)

±2kV for power supply lines

±1kV for input/output lines

±2kV for power

supply lines

N/A

Mains power quality should

be that of a typical

commercial or hospital

environment.

IEC 61000-4-5

Surge

±0.5kV Differential

±1kV Differential

±2kV Common

0 – 270º

±0.5kV Differential

±1kV Differential

±2kV Common

0 – 270º

Mains power quality should

be at levels characteristic of

a typical commercial or

hospital environment.

IEC 61000-4-8

Power Frequency

(50/60Hz)

Magnetic Field

3A/m

3A/m

Power frequency magnetic

fields should be that of a

typical commercial or

hospital

environment.

IEC 61000-4-11

Voltage Dips/

Dropout

>95% Dip for 0.5 Cycles

60% Dip for 5 Cycles

30% Dip for 25 Cycles

>95% Dip for 250 Cycles

>95% Dip for 0.5

Cycles

60% Dip for 5 Cycles

30% Dip for 25

Cycles

>95% Dip for 250

Cycles

Mains power quality should

be that of a typical

commercial or hospital

environment.

If the clinical user of the

device requires continued

operation during power

mains interruptions, it is

recommended that the

device be powered from an

uninterruptible power supply

or battery.

CyberLogic, Inc.

Table 204: Guidance and Manufacturer’s Declaration – Immunity

This product is intended for use in the electromagnetic environment specified

below. The clinical user should ensure that it is used in such an environment.

Immunity Test

IEC 60601-

1-2 Test

Level

RF

Compliance

Level

Electromagnetic

Environment - Guidance

IEC 61000·4·6

Conducted RF

IEC 61000·4·3

Radiated RF

3.0 Vrms

150 kHz - 80 MHz

3 V/m

80 MHz - 2.5 GHz

V1=3.0 Vrms

150 kHz - 80 MHz

E1=3 V/m

80 MHz - 2.5 GHz

Portable and mobile RF

Communications equipment should be

used no closer to any part of this

device, including cables, than the

recommended separation distance

calculated from the equations listed

below, as applicable to the frequency of

the transmitter:

D =

3.5

V1

P = 1.17 P

D =

3.5

E1

P = 1.17 P 80 − 800 MHz

D =

7

E1

P = 2.33 P 800 MHz − 2.5GHz

where

P = max power in watts

D= recommended separation distance

in meters

Field strengths from fixed transmitters,

as determined by an electromagnetic

site survey (e), should be less than the

RF Compliance Level in each frequency

range (f).

Interference may occur in the

vicinity of equipment containing

the transmitter symbol:

NOTES:

a. At 80 MHz and 800 MHz, the higher frequency range applies.

b. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects, and people.

c. The RF Compliance Levels in the ISM frequency bands between 150 kHz - 80 MHz and in the frequency range 80

MHz - 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause

interference if It is Inadvertently brought into patient areas.

d. The ISM (Industrial, Scientific, and Medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;

13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

e. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with

accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey

should be considered. If the measured field strength in the location in which the device is used exceeds the

applicable RF Compliance Levels listed above, the medical device should be observed to verily normal operation. If

abnormal performance is observed, additional measures may be necessary, such as separating, reorienting, or

relocating the medical device.

f. Over the frequency range 150 kHz - 80 MHz, field strengths should be less than 3 V/m.

CyberLogic, Inc.

Table 206: Guidance and Manufacturer’s Declaration - Recommended Separation

Distances According to Frequency of Transmitter

This product is intended for use in the electromagnetic environment specified

below.

The device is intended for use in the electromagnetic environment in which

radiated disturbances are controlled. The customer or user of the device can help

prevent electromagnetic interference by maintaining a minimum distance between

portable and mobile RF Communications Equipment and the device as

recommended below, according to the maximum output power of the

communications equipment.

Max

Outp

ut

Powe

r

(Watt

s)

Separation

(m)

150kHz -

80MHz

D =

3.5

V1

P = 1.17 P

Separation

(m)

80 - 800MHz

D =

3.5

E1

P = 1.17 P

Separation

(m)

800MHz -

2.5GHz

D =

7

E1

P = 2.33 P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters

(m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum

output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.