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1. QUANTUM II amp QUANTUM X BIOELECTRICAL IMPEDANCE ANALYZERS Bioelectrical Body Composition Analyz I fer Bioelectrical Body Composition Analyz alyzer I U c E Quantum X Revision Date November 9 2007 Table of Contents Proper Care of Your Instrument and Accessories Instrument Do s Instrument Don ts Subject Cables Software Replacing the BIA 9 volt Alkaline Battery Storing the Instrument Shipping and Transporting the Instrument Testing of the BIA Instrument When to Test Testing Procedure Potential Causes of Unusual BIA or Body Composition Results Electrode Placement Subject Preparation and Test Procedure Electrode Placement Subject Preparation BIA Testing Procedure Testing Procedure oo DI tn bh ip Operator Examiner Required Proficiency Frequently Asked Questions Performing the Bioelectrical Impedance Analysis BIA Test Validity N Equipment A Software Ordering and Warranty Proper Care of Your Instrument and Accessories Instrument Do s Protect the instrument from physical abuse like any electronic product your instrument can be damaged by being dropped shaken or thrown Please follow the instructions on pa
2. middle oe Se Subject Preparation The subject should not have exercised or taken a sauna within 8 hours of the test The subject should refrain from alcohol intake for 12 hours prior to the test The subject s height and weight should be accurately measured and recorded The subject should not be moist from sweat or lotion The subject should not have a fever or be in shock The subject s height and weight should be accurately measured and recorded The study and testing procedure should be explained to the subject OOOOCOUD BIA Testing Procedure The exam area should be comfortable and free of drafts and portable electric heaters The exam table surface must be non conductive and large enough for the subject to lie supine with the arms 30 degrees from the body and legs not in contact with each other The Quantum analyzer should have a new 9 volt battery The analyzer calibration and patient cables should be checked regularly DO Testing Procedure a OO D OO D The subject should remove the right shoe and sock generally the study is completed on the right side of the body The body side left or right should always be used subsequently The subject should lie supine with the arms 30 degrees from the body and legs not touching and remove jewelry on the electrode side The electrode sites may be cleaned with alcohol particularly if the skin is dry or covered with lotion Attach the electrodes and pati
3. be serviced 2 Place the instrument in its original packing material if possible The instrument is fragile and should not be exposed to unnecessary abuse 3 In the event the instrument needs to be returned to RJL Systems ALWAYS include the subject cables so that the entire system may be checked 4 Send the instrument to RJL Systems Inc 33939 Harper Avenue Clinton Twp MI 48035 Testing the BIA Instrument When to Test The BIA instrument should be tested with the 500 ohm test resistor When the battery is replaced When the BIA technician believes the BIA measurements are unusual When the subject cable may have incurred damage Prior to a large number of tests for a study RJL Systems customers have tested or calibrated their instruments Prior to every test At the beginning of a testing day Once a week Once a month Once a quarter After storage ABS Please note Tests that need to be retested due to calibration issues could be eliminated with the calibration test It will not cause any problems to test or calibrate the instrument fre quently Connecting the leads and clips to the test resistors Acceptable Resistance 495 to 505 Acceptable Reactance 003 to 003 Test resistor is located in plastic test tube supplied with all RJL instruments 500 Ohm test resistor Testing Procedure The following steps will test the impedance circuitry the subject cables the subject
4. cable connector and the battery 1 First make sure the instrument has a new 9 volt alkaline battery if necessary 2 Attach the 500 ohm test resistor located in the plastic test tube as shown in the diagram above Turn the instrument on and note the resistance value displayed The test resistor should not be held by the technician during testing or calibrating to ensure proper measurement of readings The resistance value should be between 495 and 505 ohms Then switch the instrument to the reactance measurement The reactance value should be 003 to 003 Readings inside these ranges indicates that the impedance circuitry is in good working order To check the subject cable a Verify that the connector is completely inserted in the instrument b Turn the instrument on and put it in Resistance mode c Move the cables gently up and down the whole length of the cable especially near the end of the blue portion of the cable and right at the clips Please note if there are unusual jumps in the resistance reading while performing this test there is probably a break in the cables and you should replace the cables For example the resistance value starts at 499 and while moving the cables it jumps to 283 If all the previous steps were performed with good results your BIA instrument and cable are working properly In the event results were not within the acceptable ranges contact RJL Systems and speak with someone in the
5. custom and duties charges or issues Does RJL supply a service manual complete with schematics to a government agency whose bioengineering department requires this information Yes RJL may release the service manuals complete with schematics to major universities hospitals etc ONLY An original company non disclosure contract must be signed prior to the release of this information the requested information is proprietary to RJL Systems Inc What is and is not covered by the RJL Warranty Parts and service labor on the BIA unit is covered for one year Return shipping within the US and Canada is covered for a period of one year Cables such as power cords and subject cables are not covered by the warranty Extended warranties are available 15
6. ance and reactance results 11 II 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 196 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 profes sional consultation How often should the test be performed This would depend on your facility and your client The average professional gener ally 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 Validity How does bioelectrical impedance analysis work Please visit our website for an explanation http rjlsystems com docs bia_info fundamentals What is resistance reactance and phase angle Please visit http rjlsystems com docs bia_info principles for an explanation of resistance reactance and phase angle 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 nationality No because race gender and disease do not affect the r
7. ant 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 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 to 16 months Expired electrodes will produce inaccurate results As well if electrodes are not kept in a sealed bag or con tainer they can dry out and also produce inaccurate results 10 Is there anything particular that the test subject should do prior to being tested with the RJL Analyzer The test subject s 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 re sults If a per
8. back up of the software data saving databases created by your office is recommended This will prevent loss of essential patient data in the event some thing happens to the computer the software is located on Please note the software name version and build numbers the support staff at RJL Systems will need this information to offer assistance regarding software related issues Replacing the 9 volt Alkaline Battery When the Quantum battery is weak decimal points will be displayed on the impedance me ter for example 5 0 0 When this occurs the results will not be accurate until the battery is changed Therefore prior to testing with the Quantum replace the battery with a new 9 volt alkaline battery and test the analyzer with the 500 ohm test resistor as described in Testing or Calibration of the BIA Instrument on page 5 Storing an Instrument Quantum II and Quantum X 1 Disconnect the subject cables from the instrument 2 Store inside the carrying case in a dry cool environment Shipping and Transporting an Instrument 1 DO NOT RETURN THE INSTRUMENT TO RJL SYSTEMS WITHOUT PRIOR AUTHORIZATION FROM RJL SYSTEMS The majority of problems can be solved over the phone See Testing or Calibrating the BIA instrument However if the instrument does need to be returned a Return Merchandise Authorization RMA number will be issued Please include the RMA number on the return package In struments sent in without a RMA number may NOT
9. efer to page 6 of this 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 How do I know when the BIA instrument needs a new battery A line of decimal points will appear at the bottom of the LCD screen 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 http www accessdata fda gov scripts cdrh cfdocs cfRL listing cfm ID 14066 or http www accessdata fda gov scripts cdrh cfdocs cfPMN pmn cfm Search for RJL Systems under Applicant Name or Owner Name 13 IV What is the difference between the Quantum II analyzer and the Quantum X The differences between the two units are resolution The Quantum II has a resolu tion 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 weighs 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
10. ent cables as shown in the illustration Turn the analyzer on and make sure the subject refrains from moving When the measurements have stabilized record the displayed Resistance R and Reactance Xc with the subject s name age gender height and weight Remove and dispose of the electrodes be careful not to injure the subject s skin or contaminate the operator The entire testing time is less than 5 minutes the BIA analyzer is on for less than one minute The results are available immediately from the software program The study may be repeated as often as necessary Operator examiner must demonstrate the following level of proficiency Two consecutive measurements made on a single stable subject must result in Resistance values within one percent of each other BIA Frequently Asked Questions FAQ Table of Contents I Performing the Bioelectrical Impedance Analysis BIA Test II Validity III Equipment IV Software V Ordering amp Warranty Performing the Bioelectrical Impedance Analysis BIA Test Should the test subject lie down to be tested 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 import
11. epeatability of the results How and why does dehydration affect the BIA test Changes in hydration are proportional to changes of extracellular water and therefore affect the absolute volume of fat free mass and fat However weight is also changing proportionally when fat or fat free mass is expressed as a percent of weight the results should be consistent 12 III Is it possible for a person to drink too much water prior to being tested No it is nearly impossible for a healthy individual to become over hydrated Drink ing a lot of water immediately before being tested will not affect the accuracy of the test as all the water will be in the trunk area only and not dispersed throughout the body It will take a dehydrated person s muscles at least several hours to absorb the water 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 Please visit our website http rjlsystems com docs animals for more information Equipment How long has RJL been manufacturing BIA analyzers RJL has been manufacturing BIA analyzers since 1979 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 r
12. ge 5 titled Shipping and Transporting Your Instrument when shipping your instrument Protect from extreme humidity store the instrument in humidity that does not exceed 90 as exceeding this level may impair its performance Protect from extreme heat and cold storing the instrument in conditions that are ex tremely hot or cold may permanently damage the internal components Instrument Don ts Never eat or drink near the instrument beverages spilled on the instrument will perma nently damage the sensitive electronic equipment of the instrument Never submerse the instrument in water Never disassemble the case there are no user serviceable parts within the BIA instrument If you remove the screws that hold the case together you may damage the static sensitive circuitry and the batteries Please note disassembling the case will VOID your warranty Subject Cables 1 The subject cables should be handled with care 2 When removing the cable from the instrument pull back gently on the outershell or housing checkerboard appearance and then pull the cable out of the instrument 3 Clean the alligator clips occasionally with rubbing alcohol to remove potential build up or gel Software Take care of the software CD your software manual came with a plastic CD pocket back cover When the CD is not in use the CD should remain in the holder to avoid potential damage to the disk Periodically perform a
13. ontact RJL for details For specific software questions please feel free to contact RJL at 1 800 528 4513 or visit our web site at www rjlsystems com for information regarding our soft ware 14 Ordering amp Warranty How would I go about placing an order To order supplies contact RJL Systems Call 1 800 528 4513 Order online at www rjlsystems com Fax your order to 1 586 790 0205 You can contact our sales department in any of the following ways Call 1 800 528 4513 E mail our sales department at sales rjlsystems com Fax a request for a quote to 1 586 790 0205 Please indicate in your fax if you would like the quote to be mailed or e mailed to you or if you require personal assistance Fill out our Information Request Form on our website and we will contact you What methods of payment are acceptable when I place an order with RJL Systems Inc Orders must be placed directly with RJL at 33939 Harper Avenue Clinton Twp MI 48035 Terms include Visa MasterCard AMEX C O D U S orders only Check or Purchase Order restrictions apply call for details or wire transfer Can I place an order and have it shipped someplace other than my billing address Yes all of the RJL analyzers and products may be shipped directly to anywhere in the world All such shipments must be paid for prior to delivery via wire transfer Visa Mastercard or American Express or receipt of check RJL is not responsible for
14. service department Please have your results available or be prepared to run these tests again when you call Potential Causes of Unusual BIA or Body Composition Results 1 2 3 A malfunctioning BIA instrument See Testing the BIA Instrument on page 6 Damaged subject cables See Testing the BIA Instrument on page 6 Expired adhesive electrodes RJL Systems adhesive electrodes have an average shelf life of 15 months Subject in contact with a conductive metal table while testing See BIA Testing Procedure Subject has recently used lotion at the electrode placement sites See BIA Testing Procedure Error in data entry of subject information into body composition software a Gender incorrect male vs female b Weight number transposed 158 vs 185 c Height input as feet instead of inches 5 6 typed 56 vs 66 d Height or weight entered in English units when the drop down is set to Metric or vice versa Subject did not follow protocol instructions See Subject preparation on page 8 Low Battery See Replacing the 9 volt Battery on page 5 7 Electrode Placement Subject Preparation and Test Procedure Electrode Placement Detecting electrod W edgeis placed on an imaginary line bisecting the gt head bone on Hie 7 i ides of ankle Signal erode my 4 is placed on the first joint of the lt
15. son 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 affect on the BIA test provided the jewelry does not interfere with electrode placement However we recommend that all jewelry be removed Do pins in a subject s arms or legs affect the BIA readings No pins in a subject s arms or legs will not affect the BIA readings Can people with pacemakers be tested with the RJL analyzers No people with implanted electronic devices such as pacemakers or defibrillators should NOT be tested due to the possibility of interference of the BIA signal with the defibrillator 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 At what age can children be tested Equations were developed on children beginning at age 8 However people of any age may be tested for resist
16. test with equally accurate resistance and reactance results and all RJL BIA results can be en tered into the our current software for body composition analysis What is the life expectancy of an RJL analyzer It is many years so long as you take care of your analyzer RJL still has many of their customers from as far back as 1980 using their originally purchased analyzers However with any type of equipment the age of the instrument may affect reliabil ity As a result of continual use parts may wear out and need replacement Are the RJL analyzers very difficult to operate No anyone can operate the RJL analyzers It is helpful however to read the supplied manual first Software What are the minimum system hardware requirements to run the RJL Systems body composition software Windows 95 98 NT 4 0 2000 ME XP 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 What are the system software requirements to run RJL software To run the RJL software your system must have Windows 95 or higher What programming language is RJL software written in Our software is written in the Perl language If you have a copy of Perl installed on your computer the RJL software may have issues Please c
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