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