RJL Systems is Temporarily Closed Due to the COVID-19 Pandedmic

In an attempt to slow the spread of the disease, on March 23, 2020, Michigan Governor Gretchen Whitmer ordered that all businesses suspend in-person operations and any individuals not engaged in essential activities stay home. The current order will be

FAQs

About RJL Systems

Every time I call, I end up at someone’s voicemail. I never seem to be able to reach a live person!

Our dedicated staff WANTS to speak with you. However, like all businesses, there are peak times when call volume is very high. RJL employees work very hard to make sure everyone that calls us, gets the service and support they are entitled to. If you do get transferred to our Voice Mail system, PLEASE do not hang up – if you leave a message, our staff WILL call you back and provide the assistance you need.

Performing a BIA test

Should the test subject lie down to be tested?

Yes. All research has been performed with the subject lying flat with legs apart and arms not touching the body, therefore it is recommended that the test subject lie down to be tested.

What side of the body is used for BIA testing?

The right side of the body is commonly used for BIA testing. However, the left side of the body may be used if necessary. It is important to be consistent and use the same side on a test subject for repeatability.

Can you feel the test while it is being performed?

No, the current passed through the body is so small that it is unlikely it will be felt at all.

How long does it take to perform a BIA test on a subject?

Typically, the test will take approximately five minutes, including entering the information into the software and generating the report.

What electrodes can be used for testing?

RJL Systems, Inc. (RJL) suggests that the tests be performed using the adhesive electrodes supplied by them. RJL cannot guarantee accurate test results acquired by using other electrodes.

Do I have to use new electrodes for every test subject?

Yes, for accuracy, and above all, for sanitary reasons, new electrodes should be used for each test performed.

Can the age of electrodes affect results?

Yes, RJL electrodes have a shelf life of 14 months. Expired electrodes will produce inaccurate results. As well, if electrodes are not kept in a sealed bag or container, they can dry out and also produce inaccurate results.

Is there anything particular that the test subject should do prior to being tested with the RJL Analyzer?

The test subjects body should be dry; no fever should be present, and should not be chilled or cold. Please review “Subject Protocol” on the “Electrode Placement” card.

Could very dry or very oily skin affect the BIA readings?

Yes. Good contact between the skin and electrodes must be made for accurate results. If a person’s skin is oily, wipe the area with an alcohol swab before positioning the electrodes. If the skin is very dry, use an electrode gel.

Do women have to remove their nylons before testing?

Yes, the adhesive electrodes must make direct contact with the skin for an accurate measurement.

Will jewelry affect the BIA test?

No, there will be no effect on the BIA test provided the jewelry does not interfere with electrode placement. However we recommend that all jewelry be removed.

Do pins or rods in a subject’s arms or legs affect the BIA readings?

If they are metallic and within the signal path, yes, they can impact the readings. If the person only has pins or rods on one side of the body, test the person on the opposite side. If the implants are bilateral, the person can still be tested, with the understanding that the estimated body composition values may not be accurate. HOWEVER, serial measurements would allow you to track which direction each compartment is trending, even if you didn’t have any confidence in the specific value reported.

Can people with implanted devices such as defibrillators, pacemakers, medication pumps, etc be tested with the RJL analyzers?

There are two issues to consider in attempting to answer this type of question:

  1. Could the other device interfere with the RJL Analyzer? 

    For us to answer the first question is relatively straightforward. The presence of an implanted device in the body will likely have a small impact on the measured resistance and reactance values, which will, in turn have a small impact on the estimated body composition. However, this effect should be consistent between tests, so even if the body fat estimate (for example) is offset by the implant, if subsequent tests show the estimated body fat decreasing, you can be confident that the body fat is, in fact, decreasing.Implanted Cardioverter Defibrillators (ICDs) are a special category of device. Because they work by delivering a large voltage to the heart, there is a chance that the BIA may be damaged if it is connected when the Defibrillator discharges.

  2. Could the RJL Analyzer interfere with the other device? 

    You will need to ask the manufacturer of the other device. Give them the link to this page, and tell them that if they need more information, they can email support@rjlsystems.com or contact us by phone.RJL Systems’ analyzers measure impedance using a 50 kHz sinusoidal signal that adheres to the requirements of IEC 60601-1:2007 for Patient Auxiliary Current in a Type BF applied device.

 

Will medication affect the reliability of the BIA test?

Changes in the results may come from medications, disease and nutritional status. BIA results quantitatively illustrate all of these factors and conditions. That’s what BIA is all about!

Can obese or emaciated test subjects be tested with the RJL analyzers?

Yes, and serial testing will reflect changes in a person’s body composition.

Can pregnant women be tested with the RJL analyzers?

No. None of the equations provided by RJL Systems have been validated for use during pregnancy, and with all of the changes that occur in the woman’s body and in the developing child, you could not be confident in the accuracy of the body composition estimates.

At what age can children be tested?

Equations were developed on children beginning at age 4. However, people of any age may be tested for resistance and reactance results.

Are medical professionals the only people that should perform the BIA test?

No, anyone that has been properly trained can perform the test. Once trained, a technician should be able to retest a patient (changing electrodes) to within a 1% difference in the resistance reading.

What is the average amount charged for a BIA test?

$15.00 charge at a health fair and $25.00 to as high as $150.00 for a test done in other environments. The price will depend on the location and the degree of professional consultation.

How often should the test be performed?

This would depend on your facility and your client. The average professional generally tests every four to six weeks.

How could the RJL analyzer be useful in my everyday practice?

Examples would be a post delivery weight reduction program in an OBGYN setting or lifestyle change in a wellness setting.

Are there any CPT codes I can use to get insurance reimbursement for doing a BIA test?

At this time, there are no CPT codes specific to BIA. That being said, we have gotten reports from some of our customers of codes that they had been able to get reimbursement under. We have prepared a list of these codes – Click to View

Other Questions

What’s the story with the Cyprus program? Why isn’t it available anymore?

To answer that question, it helps to review some history. RJL Systems received its first 510(k) clearance from the FDA to distribute a BIA Body Composition Analyzer in 1983. Once you have permission from the FDA to distribute a medical device, there are rules on what sorts of changes that you are allowed to make to the cleared product before you have to go back to the FDA and get a new clearance. In 1986, we developed the BIA-103, which was a stand-alone system that integrated the BIA with an off-the-shelf portable computer. Because our previous clearance was for a BIA  and accompanying software, and not for a computer with a built-in BIA, we needed a new 510(k), which we were granted in 1987.Fast-forward to the mid-1990s. Body composition researchers rediscovered the idea of subdividing Fat-Free Mass into “metabolically active cells” (called Body Cell Mass, or BCM) and “everything else” (called Extra-Cellular Mass, or ECM) – an idea first published in 1963. Papers were published in scientific and medical journals that showed that BCM and ECM could be estimated using BIA with a reasonable amount of accuracy. Some of these researchers approached RJL about adding these (and other) values to those already being calculated by our software.

RJL management reviewed the rules on making changes to a device and concluded that, since all they were proposing was to calculate a few additional values from information that the company was already cleared to collect and report, a new 510(k) clearance was not required. RJL developed and released the “Fluid and Nutrition Analysis” (abbreviated as “FNA”) program for computers running MS-DOS. In the late 1990’s, RJL updated FNA to take advantage of the graphical capabilities of Windows, and named the result “Cyprus”.

RJL management was wrong. In a document the FDA published in 1997 in an attempt to clarify the rules, they state that any change that adds to the list of values being reported (or “Indications for Use”) generally requires a new 510(k) clearance. Despite regular contact with the FDA, RJL was not made aware of this document or that there was a problem until 2005. At that time, RJL realized that they could not legally continue distributing Cyprus. As a result, Cyprus was discontinued and replaced with “Lean Body”, which only reported the values that RJL had clearance for, and RJL began the process of trying to get clearance for the “new” values found in Cyprus.

Eventually, in 2007, RJL was able to get clearance to report “Intra-Cellular Water” (ICW) and “Extra-Cellular Water” (ECW) – the amount of water found inside the body’s cells and the remaining water outside the cells, respectively — and RJL released the program titled “BC (Body Composition)”.

The remaining values that were removed from the Cyprus program (BCM, ECM, Capacitance, and Impedance Index) are “new” in the sense that no clinical utility of these values has been demonstrated to the satisfaction of the FDA, and as a result, no medical device may be distributed in the United States that reports them, until such time as a manufacturer either receives a Clearance or Approval from the FDA.

Analyzers

How will I know if my RJL analyzer is operating correctly (calibrated)?

A 500-ohm resistor is included with all the RJL analyzers. This resistor allows you to check the calibration of the analyzer. For an explanation on how to test the calibration of your unit, please refer to the manual.

Is there any chance of electrical shock while operating the RJL analyzers?

No, all of the RJL analyzers are designed with isolation transformers that prevent any harmful current from being exposed to the subject while being tested.

Will climate affect the BIA test?

Yes, but only when climate changes are extreme.

Is the RJL equipment FDA approved?

The Food and Drug Administration regulates all BIA devices as class II medical devices. Manufacturers must receive clearance from the FDA to market a class II device. Please visit the FDA website for more information on RJL registration and clearances. ( FDA Website – search for RJL Systems under Applicant Name or Owner Name.)

What is the life expectancy of an RJL analyzer?

So long as you take care of your analyzer, it can last a long time. RJL has many of their customers (from as far back as 1980) using their originally purchased analyzers.

Are the RJL analyzers very difficult to operate?

No, anyone can operate the RJL analyzers. It is helpful, however, to read the supplied manuals first.

In addition, anyone planning on using an analyzer in a clinical setting should practice applying the electrodes and collecting the resistance and reactance values to ensure that they are able to reliably and repeatably place the electrodes in the same spots on the skin every time.

How do I know when the Quantum-II or Quantum-X needs a new battery?

A line of decimal points will appear at the bottom of the LCD screen.

What is the difference between the Quantum II analyzer and the Quantum X?

The difference between the two units is the resolution. The Quantum II has a resolution to 1.0 Ohms and the Quantum X has a resolution to 0.1 Ohms., or ten times that of the Quantum II.

Both the Quantum II and the Quantum X are hand held analyzers that weigh 11 oz., and run on a 9-volt battery (ONLY).

Neither system stores data nor do they have serial communication capability.

All RJL BIA instruments test with equally accurate resistance and reactance results, and all RJL BIA results can be entered into our current software for body composition analysis.

RJL Software

How do I know which equation set I should select for an individual?

The user’s guide for your software should have a brief description of each of the equation sets, and why it was created. (It may be in the FAQ section in the back.)

In general, most people tend to use the “NHANES-III” equation set. The equations for Fat and Fat-Free Mass, and Total Body Water were developed as part of the Fels Longitudinal Study, which collected information about a large cross-section of the American population. A second study was done which showed how the equations performed on data collected in the NHANES-III survey, which also included a large cross-section of the American population. As a result, it tends to provide good estimates for body composition for individuals with relatively nondescript body types — that is, they resemble a “typical American of their sex and (approximate) age.”

However, for people who do not resemble the general population, the accuracy of these equations will tend to degrade. For example:

For people who are very thin or very skinny or who, when you look at them, you can say “Just by looking at you, I can tell that you work out on a very regular basis,” the NHANES-III set will tend to over-estimate body fat. That is, they may estimate body fat too high. For these people, we generally recommend the “Athletic” equation set.

On the other end of the spectrum, for people who are very obese, the NHANES-III equations will tend to under-estimate fat. For these people, the “Obese” equation set will likely provide a more accurate estimate.

What is the Datalogger?

The Datalogger is a program that allows the Quantum Desktop to be used to record and display real-time changes in resistance and reactance.

I don’t have a Quantum Desktop. Can I still use the Datalogger?

No. The Datalogger may only be used with the Quantum Desktop.

I purchased a Quantum Desktop, I have a CD for the body composition software, but I don’t see a CD for the Datalogger. Where is it?

The Datalogger is on the same CD as the body composition analysis software you received. The setup program should start when the CD is inserted into your drive. It will ask which analyzer you have. If you select the Quantum Desktop, you will have the opportunity to install the Datalogger.

I purchased a Quantum Desktop, I have a USB Flash Drive for the body composition software, but I don’t see one for the Datalogger. Where is it?

The Datalogger is on the same USB Flash Drive as the body composition analysis software. Browse the contents of the Flash Drive, open the “Other Software” folder, and go to “RJL Systems”.

Can the Datalogger be installed on a Mac?

Unfortunately, no. The Datalogger only runs on Windows at this time.

Can I use the Datalogger to calculate real-time changes in body composition or to diagnose a condition?

The Datalogger only records changes in resistance and reactance in real-time. Once the data has been collected and saved, you can use any spreadsheet or other application to read and process the data.

What are the minimum system requirements to run the BC software?

BC versions 1.0 – 2.1 require a Windows PC with the following:

  • 800 x 600 x 256 color screen setting
  • 30 MB of disk space minimum
  • 32 MB Memory (recommended 64 MB Memory)
  • 133 MHz Pentium Processor or equivalent (recommended 300 MHz Pentium-II Processor or equivalent)
  • Microsoft Internet Explorer 4.0 or greater (Recommended Microsoft I.E. 5.5 or greater)
  • Windows 95 / 98 / ME / 2000 / XP / 2003 / Vista / 7 / 8  — These versions have all been tested

BC version 2.1 and earlier CAN NOT be run natively on Mac OS.

The installer is asking me which analyzer I have. I have an older unit that isn’t on the list. Can I not use BC?

Some of our newer analyzers have advanced features that require additional software and/or special settings to be able to take advantage of them. This is why the installer is asking you what model analyzer you have. If you have an older analyzer that is not in the list, select the “Quantum-II”.

What programming language is BC written in?

BC versions 1.0 – 2.1 were written in Perl. If you have a copy of the Perl interpreter installed on your computer, BC may have issues. Please contact us for more information.

Can I run BC from a server across the network?

You can, but it is not recommended. Because of the way the program executable is built, you will see MASSIVE amounts of network traffic while the program is running. As a result, not only will your network be impacted, but your users will experience slow performance from BC. We recommend that BC be installed on each local workstation from which it will be used.

Can I configure BC to access databases from a centralized file server?

Yes. When you install BC, you will be presented with the choice of doing a “Standard” installation or an “Advanced” one. Choose “Advanced.” You will be given opportunities to specify locations for storing settings and databases.

I have a client who just underwent gender reassignment surgery. Now the body composition estimates are drastically different than they were before. What gives?

There’s more to being male (or female) than just your genetalia.

As we grow, our gender affects how our bones, muscles, etc grow, and how fat is distributed throughout the body. Because of this, equation sets will typically use different formulas to estimate body composition based on gender.

When entering data for a person, you should always use their biological sex / gender, regardless of which gender they currently self-identify as.

How do I create a report from the BC iPad software?

To create a formatted report, go to the Test Results and touch the “Sharing” icon at the top of the screen, and press the “Generate Report” button. If you are satisfied with the way the report looks, tap the Sharing icon again.

Press the “Email PDF” button to send the report to someone as an attachment to an email.

Or, if you have an AirPrint-enabled printer (or other third-party software to enable printing from the iPad) use the “Print PDF” button to send the report to the printer.

Can I migrate data from the database on my computer to the RJL iPad App?

Not in this initial release. Finding a way to make that work that was easy to use proved to not be a simple task. So we decided to release the app without that functionality, and release an update in iTunes when we get it figured out.

Can I access the same database from multiple iPads with the RJL app, or share it with BC on my desktop computer?

Not in this initial release. Without asking you to trust your body composition data to some third-party cloud service, finding a way to make that work that was easy to use proved to not be a simple task. So we decided to release the app without that functionality, and release an update in iTunes when we get it figured out.

What’s the story with the Cyprus program? Why isn’t it available anymore?

To answer that question, it helps to review some history. RJL Systems received its first 510(k) clearance from the FDA to distribute a BIA Body Composition Analyzer in 1983. Once you have permission from the FDA to distribute a medical device, there are rules on what sorts of changes that you are allowed to make to the cleared product before you have to go back to the FDA and get a new clearance. In 1986, we developed the BIA-103, which was a stand-alone system that integrated the BIA with an off-the-shelf portable computer. Because our previous clearance was for a BIA  and accompanying software, and not for a computer with a built-in BIA, we needed a new 510(k), which we were granted in 1987.Fast-forward to the mid-1990s. Body composition researchers rediscovered the idea of subdividing Fat-Free Mass into “metabolically active cells” (called Body Cell Mass, or BCM) and “everything else” (called Extra-Cellular Mass, or ECM) – an idea first published in 1963. Papers were published in scientific and medical journals that showed that BCM and ECM could be estimated using BIA with a reasonable amount of accuracy. Some of these researchers approached RJL about adding these (and other) values to those already being calculated by our software.

RJL management reviewed the rules on making changes to a device and concluded that, since all they were proposing was to calculate a few additional values from information that the company was already cleared to collect and report, a new 510(k) clearance was not required. RJL developed and released the “Fluid and Nutrition Analysis” (abbreviated as “FNA”) program for computers running MS-DOS. In the late 1990’s, RJL updated FNA to take advantage of the graphical capabilities of Windows, and named the result “Cyprus”.

RJL management was wrong. In a document the FDA published in 1997 in an attempt to clarify the rules, they state that any change that adds to the list of values being reported (or “Indications for Use”) generally requires a new 510(k) clearance. Despite regular contact with the FDA, RJL was not made aware of this document or that there was a problem until 2005. At that time, RJL realized that they could not legally continue distributing Cyprus. As a result, Cyprus was discontinued and replaced with “Lean Body”, which only reported the values that RJL had clearance for, and RJL began the process of trying to get clearance for the “new” values found in Cyprus.

Eventually, in 2007, RJL was able to get clearance to report “Intra-Cellular Water” (ICW) and “Extra-Cellular Water” (ECW) – the amount of water found inside the body’s cells and the remaining water outside the cells, respectively — and RJL released the program titled “BC (Body Composition)”.

The remaining values that were removed from the Cyprus program (BCM, ECM, Capacitance, and Impedance Index) are “new” in the sense that no clinical utility of these values has been demonstrated to the satisfaction of the FDA, and as a result, no medical device may be distributed in the United States that reports them, until such time as a manufacturer either receives a Clearance or Approval from the FDA.

BC 1.x - BC 2.x

How do I know which equation set I should select for an individual?

The user’s guide for your software should have a brief description of each of the equation sets, and why it was created. (It may be in the FAQ section in the back.)

In general, most people tend to use the “NHANES-III” equation set. The equations for Fat and Fat-Free Mass, and Total Body Water were developed as part of the Fels Longitudinal Study, which collected information about a large cross-section of the American population. A second study was done which showed how the equations performed on data collected in the NHANES-III survey, which also included a large cross-section of the American population. As a result, it tends to provide good estimates for body composition for individuals with relatively nondescript body types — that is, they resemble a “typical American of their sex and (approximate) age.”

However, for people who do not resemble the general population, the accuracy of these equations will tend to degrade. For example:

For people who are very thin or very skinny or who, when you look at them, you can say “Just by looking at you, I can tell that you work out on a very regular basis,” the NHANES-III set will tend to over-estimate body fat. That is, they may estimate body fat too high. For these people, we generally recommend the “Athletic” equation set.

On the other end of the spectrum, for people who are very obese, the NHANES-III equations will tend to under-estimate fat. For these people, the “Obese” equation set will likely provide a more accurate estimate.

What are the minimum system requirements to run the BC software?

BC versions 1.0 – 2.1 require a Windows PC with the following:

  • 800 x 600 x 256 color screen setting
  • 30 MB of disk space minimum
  • 32 MB Memory (recommended 64 MB Memory)
  • 133 MHz Pentium Processor or equivalent (recommended 300 MHz Pentium-II Processor or equivalent)
  • Microsoft Internet Explorer 4.0 or greater (Recommended Microsoft I.E. 5.5 or greater)
  • Windows 95 / 98 / ME / 2000 / XP / 2003 / Vista / 7 / 8  — These versions have all been tested

BC version 2.1 and earlier CAN NOT be run natively on Mac OS.

The installer is asking me which analyzer I have. I have an older unit that isn’t on the list. Can I not use BC?

Some of our newer analyzers have advanced features that require additional software and/or special settings to be able to take advantage of them. This is why the installer is asking you what model analyzer you have. If you have an older analyzer that is not in the list, select the “Quantum-II”.

What programming language is BC written in?

BC versions 1.0 – 2.1 were written in Perl. If you have a copy of the Perl interpreter installed on your computer, BC may have issues. Please contact us for more information.

Can I run BC from a server across the network?

You can, but it is not recommended. Because of the way the program executable is built, you will see MASSIVE amounts of network traffic while the program is running. As a result, not only will your network be impacted, but your users will experience slow performance from BC. We recommend that BC be installed on each local workstation from which it will be used.

Can I configure BC to access databases from a centralized file server?

Yes. When you install BC, you will be presented with the choice of doing a “Standard” installation or an “Advanced” one. Choose “Advanced.” You will be given opportunities to specify locations for storing settings and databases.

I have a client who just underwent gender reassignment surgery. Now the body composition estimates are drastically different than they were before. What gives?

There’s more to being male (or female) than just your genetalia.

As we grow, our gender affects how our bones, muscles, etc grow, and how fat is distributed throughout the body. Because of this, equation sets will typically use different formulas to estimate body composition based on gender.

When entering data for a person, you should always use their biological sex / gender, regardless of which gender they currently self-identify as.

BC 3

How do I know which equation set I should select for an individual?

The user’s guide for your software should have a brief description of each of the equation sets, and why it was created. (It may be in the FAQ section in the back.)

In general, most people tend to use the “NHANES-III” equation set. The equations for Fat and Fat-Free Mass, and Total Body Water were developed as part of the Fels Longitudinal Study, which collected information about a large cross-section of the American population. A second study was done which showed how the equations performed on data collected in the NHANES-III survey, which also included a large cross-section of the American population. As a result, it tends to provide good estimates for body composition for individuals with relatively nondescript body types — that is, they resemble a “typical American of their sex and (approximate) age.”

However, for people who do not resemble the general population, the accuracy of these equations will tend to degrade. For example:

For people who are very thin or very skinny or who, when you look at them, you can say “Just by looking at you, I can tell that you work out on a very regular basis,” the NHANES-III set will tend to over-estimate body fat. That is, they may estimate body fat too high. For these people, we generally recommend the “Athletic” equation set.

On the other end of the spectrum, for people who are very obese, the NHANES-III equations will tend to under-estimate fat. For these people, the “Obese” equation set will likely provide a more accurate estimate.

I have a client who just underwent gender reassignment surgery. Now the body composition estimates are drastically different than they were before. What gives?

There’s more to being male (or female) than just your genetalia.

As we grow, our gender affects how our bones, muscles, etc grow, and how fat is distributed throughout the body. Because of this, equation sets will typically use different formulas to estimate body composition based on gender.

When entering data for a person, you should always use their biological sex / gender, regardless of which gender they currently self-identify as.

Other Software

I have a client who just underwent gender reassignment surgery. Now the body composition estimates are drastically different than they were before. What gives?

There’s more to being male (or female) than just your genetalia.

As we grow, our gender affects how our bones, muscles, etc grow, and how fat is distributed throughout the body. Because of this, equation sets will typically use different formulas to estimate body composition based on gender.

When entering data for a person, you should always use their biological sex / gender, regardless of which gender they currently self-identify as.

What’s the story with the Cyprus program? Why isn’t it available anymore?

To answer that question, it helps to review some history. RJL Systems received its first 510(k) clearance from the FDA to distribute a BIA Body Composition Analyzer in 1983. Once you have permission from the FDA to distribute a medical device, there are rules on what sorts of changes that you are allowed to make to the cleared product before you have to go back to the FDA and get a new clearance. In 1986, we developed the BIA-103, which was a stand-alone system that integrated the BIA with an off-the-shelf portable computer. Because our previous clearance was for a BIA  and accompanying software, and not for a computer with a built-in BIA, we needed a new 510(k), which we were granted in 1987.Fast-forward to the mid-1990s. Body composition researchers rediscovered the idea of subdividing Fat-Free Mass into “metabolically active cells” (called Body Cell Mass, or BCM) and “everything else” (called Extra-Cellular Mass, or ECM) – an idea first published in 1963. Papers were published in scientific and medical journals that showed that BCM and ECM could be estimated using BIA with a reasonable amount of accuracy. Some of these researchers approached RJL about adding these (and other) values to those already being calculated by our software.

RJL management reviewed the rules on making changes to a device and concluded that, since all they were proposing was to calculate a few additional values from information that the company was already cleared to collect and report, a new 510(k) clearance was not required. RJL developed and released the “Fluid and Nutrition Analysis” (abbreviated as “FNA”) program for computers running MS-DOS. In the late 1990’s, RJL updated FNA to take advantage of the graphical capabilities of Windows, and named the result “Cyprus”.

RJL management was wrong. In a document the FDA published in 1997 in an attempt to clarify the rules, they state that any change that adds to the list of values being reported (or “Indications for Use”) generally requires a new 510(k) clearance. Despite regular contact with the FDA, RJL was not made aware of this document or that there was a problem until 2005. At that time, RJL realized that they could not legally continue distributing Cyprus. As a result, Cyprus was discontinued and replaced with “Lean Body”, which only reported the values that RJL had clearance for, and RJL began the process of trying to get clearance for the “new” values found in Cyprus.

Eventually, in 2007, RJL was able to get clearance to report “Intra-Cellular Water” (ICW) and “Extra-Cellular Water” (ECW) – the amount of water found inside the body’s cells and the remaining water outside the cells, respectively — and RJL released the program titled “BC (Body Composition)”.

The remaining values that were removed from the Cyprus program (BCM, ECM, Capacitance, and Impedance Index) are “new” in the sense that no clinical utility of these values has been demonstrated to the satisfaction of the FDA, and as a result, no medical device may be distributed in the United States that reports them, until such time as a manufacturer either receives a Clearance or Approval from the FDA.

Quantum-IV

How will I know if my RJL analyzer is operating correctly (calibrated)?

A 500-ohm resistor is included with all the RJL analyzers. This resistor allows you to check the calibration of the analyzer. For an explanation on how to test the calibration of your unit, please refer to the manual.

Is there any chance of electrical shock while operating the RJL analyzers?

No, all of the RJL analyzers are designed with isolation transformers that prevent any harmful current from being exposed to the subject while being tested.

Will climate affect the BIA test?

Yes, but only when climate changes are extreme.

Is the RJL equipment FDA approved?

The Food and Drug Administration regulates all BIA devices as class II medical devices. Manufacturers must receive clearance from the FDA to market a class II device. Please visit the FDA website for more information on RJL registration and clearances. ( FDA Website – search for RJL Systems under Applicant Name or Owner Name.)

What is the life expectancy of an RJL analyzer?

So long as you take care of your analyzer, it can last a long time. RJL has many of their customers (from as far back as 1980) using their originally purchased analyzers.

Are the RJL analyzers very difficult to operate?

No, anyone can operate the RJL analyzers. It is helpful, however, to read the supplied manuals first.

In addition, anyone planning on using an analyzer in a clinical setting should practice applying the electrodes and collecting the resistance and reactance values to ensure that they are able to reliably and repeatably place the electrodes in the same spots on the skin every time.

Quantum-III

How will I know if my RJL analyzer is operating correctly (calibrated)?

A 500-ohm resistor is included with all the RJL analyzers. This resistor allows you to check the calibration of the analyzer. For an explanation on how to test the calibration of your unit, please refer to the manual.

Is there any chance of electrical shock while operating the RJL analyzers?

No, all of the RJL analyzers are designed with isolation transformers that prevent any harmful current from being exposed to the subject while being tested.

Will climate affect the BIA test?

Yes, but only when climate changes are extreme.

Is the RJL equipment FDA approved?

The Food and Drug Administration regulates all BIA devices as class II medical devices. Manufacturers must receive clearance from the FDA to market a class II device. Please visit the FDA website for more information on RJL registration and clearances. ( FDA Website – search for RJL Systems under Applicant Name or Owner Name.)

What is the life expectancy of an RJL analyzer?

So long as you take care of your analyzer, it can last a long time. RJL has many of their customers (from as far back as 1980) using their originally purchased analyzers.

Are the RJL analyzers very difficult to operate?

No, anyone can operate the RJL analyzers. It is helpful, however, to read the supplied manuals first.

In addition, anyone planning on using an analyzer in a clinical setting should practice applying the electrodes and collecting the resistance and reactance values to ensure that they are able to reliably and repeatably place the electrodes in the same spots on the skin every time.

Quantum Desktop

How will I know if my RJL analyzer is operating correctly (calibrated)?

A 500-ohm resistor is included with all the RJL analyzers. This resistor allows you to check the calibration of the analyzer. For an explanation on how to test the calibration of your unit, please refer to the manual.

Is there any chance of electrical shock while operating the RJL analyzers?

No, all of the RJL analyzers are designed with isolation transformers that prevent any harmful current from being exposed to the subject while being tested.

Will climate affect the BIA test?

Yes, but only when climate changes are extreme.

Is the RJL equipment FDA approved?

The Food and Drug Administration regulates all BIA devices as class II medical devices. Manufacturers must receive clearance from the FDA to market a class II device. Please visit the FDA website for more information on RJL registration and clearances. ( FDA Website – search for RJL Systems under Applicant Name or Owner Name.)

What is the life expectancy of an RJL analyzer?

So long as you take care of your analyzer, it can last a long time. RJL has many of their customers (from as far back as 1980) using their originally purchased analyzers.

Are the RJL analyzers very difficult to operate?

No, anyone can operate the RJL analyzers. It is helpful, however, to read the supplied manuals first.

In addition, anyone planning on using an analyzer in a clinical setting should practice applying the electrodes and collecting the resistance and reactance values to ensure that they are able to reliably and repeatably place the electrodes in the same spots on the skin every time.

Validity of BIA

Is it possible to have too little body fat?

Yes, your body needs some fat for energy storage and normal metabolic functions.

Does RJL have software specific to race or nationality?

Our software includes several different collections of equations (called “equation sets”) to choose from, for calculating the body composition estimates. Some of these equation sets are labeled as being specific to a certain ethnicity or body type. These equation sets use equations for estimating body fat that were either developed in a study that only evaluated people of that group or were developed in a more general study but then were specifically validated for use in that group in a follow-up study.

In general, however, most people should be just fine using one of the more general-population equation sets like NHANES-III.

Have the RJL analyzers been tested on any animals?

Yes, they include: cats, dogs, fish, cows, elk, seals, polar bears, grizzly bears, orangutans, pigs, lambs, moose, deer, rats and mice, to name just a few.

That being said, please keep in mind that RJL does not provide software or equations for body composition estimates for any species other than humans.

To evaluate body composition in non-human species, you will need to find published equations that have been either developed or cross-validated for your study population and you will need to replicate the test protocol (including electrode site preparation, electrode type, and placement) used by the original researcher(s).

I have a client who just underwent gender reassignment surgery. Now the body composition estimates are drastically different than they were before. What gives?

There’s more to being male (or female) than just your genetalia.

As we grow, our gender affects how our bones, muscles, etc grow, and how fat is distributed throughout the body. Because of this, equation sets will typically use different formulas to estimate body composition based on gender.

When entering data for a person, you should always use their biological sex / gender, regardless of which gender they currently self-identify as.

BC iPad

How do I know which equation set I should select for an individual?

The user’s guide for your software should have a brief description of each of the equation sets, and why it was created. (It may be in the FAQ section in the back.)

In general, most people tend to use the “NHANES-III” equation set. The equations for Fat and Fat-Free Mass, and Total Body Water were developed as part of the Fels Longitudinal Study, which collected information about a large cross-section of the American population. A second study was done which showed how the equations performed on data collected in the NHANES-III survey, which also included a large cross-section of the American population. As a result, it tends to provide good estimates for body composition for individuals with relatively nondescript body types — that is, they resemble a “typical American of their sex and (approximate) age.”

However, for people who do not resemble the general population, the accuracy of these equations will tend to degrade. For example:

For people who are very thin or very skinny or who, when you look at them, you can say “Just by looking at you, I can tell that you work out on a very regular basis,” the NHANES-III set will tend to over-estimate body fat. That is, they may estimate body fat too high. For these people, we generally recommend the “Athletic” equation set.

On the other end of the spectrum, for people who are very obese, the NHANES-III equations will tend to under-estimate fat. For these people, the “Obese” equation set will likely provide a more accurate estimate.

How do I create a report from the BC iPad software?

To create a formatted report, go to the Test Results and touch the “Sharing” icon at the top of the screen, and press the “Generate Report” button. If you are satisfied with the way the report looks, tap the Sharing icon again.

Press the “Email PDF” button to send the report to someone as an attachment to an email.

Or, if you have an AirPrint-enabled printer (or other third-party software to enable printing from the iPad) use the “Print PDF” button to send the report to the printer.

Can I migrate data from the database on my computer to the RJL iPad App?

Not in this initial release. Finding a way to make that work that was easy to use proved to not be a simple task. So we decided to release the app without that functionality, and release an update in iTunes when we get it figured out.

Can I access the same database from multiple iPads with the RJL app, or share it with BC on my desktop computer?

Not in this initial release. Without asking you to trust your body composition data to some third-party cloud service, finding a way to make that work that was easy to use proved to not be a simple task. So we decided to release the app without that functionality, and release an update in iTunes when we get it figured out.

BC 4

How do I know which equation set I should select for an individual?

The user’s guide for your software should have a brief description of each of the equation sets, and why it was created. (It may be in the FAQ section in the back.)

In general, most people tend to use the “NHANES-III” equation set. The equations for Fat and Fat-Free Mass, and Total Body Water were developed as part of the Fels Longitudinal Study, which collected information about a large cross-section of the American population. A second study was done which showed how the equations performed on data collected in the NHANES-III survey, which also included a large cross-section of the American population. As a result, it tends to provide good estimates for body composition for individuals with relatively nondescript body types — that is, they resemble a “typical American of their sex and (approximate) age.”

However, for people who do not resemble the general population, the accuracy of these equations will tend to degrade. For example:

For people who are very thin or very skinny or who, when you look at them, you can say “Just by looking at you, I can tell that you work out on a very regular basis,” the NHANES-III set will tend to over-estimate body fat. That is, they may estimate body fat too high. For these people, we generally recommend the “Athletic” equation set.

On the other end of the spectrum, for people who are very obese, the NHANES-III equations will tend to under-estimate fat. For these people, the “Obese” equation set will likely provide a more accurate estimate.

I have a client who just underwent gender reassignment surgery. Now the body composition estimates are drastically different than they were before. What gives?

There’s more to being male (or female) than just your genetalia.

As we grow, our gender affects how our bones, muscles, etc grow, and how fat is distributed throughout the body. Because of this, equation sets will typically use different formulas to estimate body composition based on gender.

When entering data for a person, you should always use their biological sex / gender, regardless of which gender they currently self-identify as.

Datalogger

What is the Datalogger?

The Datalogger is a program that allows the Quantum Desktop to be used to record and display real-time changes in resistance and reactance.

I don’t have a Quantum Desktop. Can I still use the Datalogger?

No. The Datalogger may only be used with the Quantum Desktop.

I purchased a Quantum Desktop, I have a CD for the body composition software, but I don’t see a CD for the Datalogger. Where is it?

The Datalogger is on the same CD as the body composition analysis software you received. The setup program should start when the CD is inserted into your drive. It will ask which analyzer you have. If you select the Quantum Desktop, you will have the opportunity to install the Datalogger.

I purchased a Quantum Desktop, I have a USB Flash Drive for the body composition software, but I don’t see one for the Datalogger. Where is it?

The Datalogger is on the same USB Flash Drive as the body composition analysis software. Browse the contents of the Flash Drive, open the “Other Software” folder, and go to “RJL Systems”.

Can the Datalogger be installed on a Mac?

Unfortunately, no. The Datalogger only runs on Windows at this time.

Can I use the Datalogger to calculate real-time changes in body composition or to diagnose a condition?

The Datalogger only records changes in resistance and reactance in real-time. Once the data has been collected and saved, you can use any spreadsheet or other application to read and process the data.

Quantum-II

How will I know if my RJL analyzer is operating correctly (calibrated)?

A 500-ohm resistor is included with all the RJL analyzers. This resistor allows you to check the calibration of the analyzer. For an explanation on how to test the calibration of your unit, please refer to the manual.

Is there any chance of electrical shock while operating the RJL analyzers?

No, all of the RJL analyzers are designed with isolation transformers that prevent any harmful current from being exposed to the subject while being tested.

Will climate affect the BIA test?

Yes, but only when climate changes are extreme.

Is the RJL equipment FDA approved?

The Food and Drug Administration regulates all BIA devices as class II medical devices. Manufacturers must receive clearance from the FDA to market a class II device. Please visit the FDA website for more information on RJL registration and clearances. ( FDA Website – search for RJL Systems under Applicant Name or Owner Name.)

What is the life expectancy of an RJL analyzer?

So long as you take care of your analyzer, it can last a long time. RJL has many of their customers (from as far back as 1980) using their originally purchased analyzers.

Are the RJL analyzers very difficult to operate?

No, anyone can operate the RJL analyzers. It is helpful, however, to read the supplied manuals first.

In addition, anyone planning on using an analyzer in a clinical setting should practice applying the electrodes and collecting the resistance and reactance values to ensure that they are able to reliably and repeatably place the electrodes in the same spots on the skin every time.

How do I know when the Quantum-II or Quantum-X needs a new battery?

A line of decimal points will appear at the bottom of the LCD screen.

What is the difference between the Quantum II analyzer and the Quantum X?

The difference between the two units is the resolution. The Quantum II has a resolution to 1.0 Ohms and the Quantum X has a resolution to 0.1 Ohms., or ten times that of the Quantum II.

Both the Quantum II and the Quantum X are hand held analyzers that weigh 11 oz., and run on a 9-volt battery (ONLY).

Neither system stores data nor do they have serial communication capability.

All RJL BIA instruments test with equally accurate resistance and reactance results, and all RJL BIA results can be entered into our current software for body composition analysis.

Quantum-X

How will I know if my RJL analyzer is operating correctly (calibrated)?

A 500-ohm resistor is included with all the RJL analyzers. This resistor allows you to check the calibration of the analyzer. For an explanation on how to test the calibration of your unit, please refer to the manual.

Is there any chance of electrical shock while operating the RJL analyzers?

No, all of the RJL analyzers are designed with isolation transformers that prevent any harmful current from being exposed to the subject while being tested.

Will climate affect the BIA test?

Yes, but only when climate changes are extreme.

Is the RJL equipment FDA approved?

The Food and Drug Administration regulates all BIA devices as class II medical devices. Manufacturers must receive clearance from the FDA to market a class II device. Please visit the FDA website for more information on RJL registration and clearances. ( FDA Website – search for RJL Systems under Applicant Name or Owner Name.)

What is the life expectancy of an RJL analyzer?

So long as you take care of your analyzer, it can last a long time. RJL has many of their customers (from as far back as 1980) using their originally purchased analyzers.

Are the RJL analyzers very difficult to operate?

No, anyone can operate the RJL analyzers. It is helpful, however, to read the supplied manuals first.

In addition, anyone planning on using an analyzer in a clinical setting should practice applying the electrodes and collecting the resistance and reactance values to ensure that they are able to reliably and repeatably place the electrodes in the same spots on the skin every time.

How do I know when the Quantum-II or Quantum-X needs a new battery?

A line of decimal points will appear at the bottom of the LCD screen.

What is the difference between the Quantum II analyzer and the Quantum X?

The difference between the two units is the resolution. The Quantum II has a resolution to 1.0 Ohms and the Quantum X has a resolution to 0.1 Ohms., or ten times that of the Quantum II.

Both the Quantum II and the Quantum X are hand held analyzers that weigh 11 oz., and run on a 9-volt battery (ONLY).

Neither system stores data nor do they have serial communication capability.

All RJL BIA instruments test with equally accurate resistance and reactance results, and all RJL BIA results can be entered into our current software for body composition analysis.

Quantum-V

Is there any chance of electrical shock while operating the RJL analyzers?

No, all of the RJL analyzers are designed with isolation transformers that prevent any harmful current from being exposed to the subject while being tested.

Will climate affect the BIA test?

Yes, but only when climate changes are extreme.

Is the RJL equipment FDA approved?

The Food and Drug Administration regulates all BIA devices as class II medical devices. Manufacturers must receive clearance from the FDA to market a class II device. Please visit the FDA website for more information on RJL registration and clearances. ( FDA Website – search for RJL Systems under Applicant Name or Owner Name.)

What is the life expectancy of an RJL analyzer?

So long as you take care of your analyzer, it can last a long time. RJL has many of their customers (from as far back as 1980) using their originally purchased analyzers.

Are the RJL analyzers very difficult to operate?

No, anyone can operate the RJL analyzers. It is helpful, however, to read the supplied manuals first.

In addition, anyone planning on using an analyzer in a clinical setting should practice applying the electrodes and collecting the resistance and reactance values to ensure that they are able to reliably and repeatably place the electrodes in the same spots on the skin every time.

Go to the category list