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Fluke Biomedical Index 2MF, User Manual

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Index 2MF 

Users Guide 

2-4 

References 

•

 

Accuracy and Precision of Fourteen Pulse Oximeters

, B. Hannhart, 

et al

, Neonatal Intensive Care, 

Nov./Dec. 1991. 

•

 

Clinical Pulse Oximetry

, Thomas L. Petty, MD, Anesthesiology, v. 70, no. 1, Jan. 1989. 

•

 

Oximetry/Blood Gas

,  --- , Medical

 

Electronics, Oct. 1989. 

•

 

The Concise Columbia Encyclopedia,

 (Columbia University Press, 1991), Microsoft Bookshelf, 1992. 

Summary of Contents for Biomedical Index 2MF

Page 1: ...lator Users Manual PN 3341210 September 2008 Rev 1 2008 Fluke Corporation All rights reserved Printed in USA Specifications subject to change without notice All product names are trademarks of their r...

Page 2: ...SICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER THE WARRANTY Items such as cables and nonserialized modules are not covered under this warranty Recalibration of instruments is not...

Page 3: ...ent is delivered in good physical condition but does not operate within specifications or if there are any other problems not caused by shipping damage please contact Fluke Biomedical or your local sa...

Page 4: ...ebiomedical com Everett Calibration Lab Tel 1 888 993 5853 Email service status fluke com In Europe Middle East and Africa Eindhoven Calibration Lab Tel 31 402 675300 Email ServiceDesk fluke com In As...

Page 5: ...munity 1 3 USA FCC CLASS A 1 3 Canadian Department of Communications Class A 1 4 Safety 1 4 EC Directive 73 23 EEC Low Voltage Directive 1 4 Getting Started 1 4 Starting the Simulator and Using Menus...

Page 6: ...u 1 6 4 Using Preset Patient Conditions 6 4 Setting the Light Artifact 6 7 Setting 02 and Pulse Rate Step Size 6 8 7 Testing the Pulse Oximeter Limits 7 1 Introduction 7 1 Testing Pulse Oximeter Limit...

Page 7: ...d Testing 11 1 Manufacturer Parameters Available For Simulations 11 1 Mathematical Background 11 2 Notes on the Formulas 11 3 The R Value Equation 11 3 Accessing Manufacturers Tests 11 4 Setting the S...

Page 8: ...Index 2MF Users Guide iv...

Page 9: ...able Title Page 5 1 Oximeters with Technology Options 5 4 5 2 Oximeters with R Curve Parameters 5 4 6 1 Simulations Menu Selections 6 2 6 2 Level 0 Presets 6 5 6 3 Light Artifacts 6 7 8 1 Automatic Te...

Page 10: ...Index 2MF Users Guide vi...

Page 11: ...for Determining Saturated Oxygen Level 2 2 2 3 Diagram of Sample Finger Probe for a Typical Pulse Oximeter 2 3 2 4 Diagram of Light Absorbers in Tissue 2 3 2 5 AC DC Infrared and Red Absorption Ratio...

Page 12: ...Index 2MF Users Guide viii...

Page 13: ...he simulations Electrically the Simulator can verify probe diodes wire continuity LEDs and oximeter accuracy Like all of Fluke Biomedical s hardware and software systems the Simulator is backed by Flu...

Page 14: ...lead acid battery with 8 hours of continuous operation and built in low battery indicator Package Contents The contents of the Simulator package as shipped include F Version Index 2MF Pulse Oximeter...

Page 15: ...Electromagnetic Interference and Susceptibility EC EMC Directive 89 336 EEC EN 50081 1 CLASS A Emissions The Simulator has been type tested by an independent testing laboratory and found to meet the...

Page 16: ...ectromagnetic sources such as electrosurgery equipment It may also be affected by imaging equipment such as Magnetic Resonance Imaging MRI It is the user s responsibility to verify performance of the...

Page 17: ...n saturation levels and heart rate in beats per minute BPM Press the softkey MAN to set the Sp02 levels from 35 to 100 and the heart rate from 25 to 250 BPM 1 The LCD indicates current Sp02 level and...

Page 18: ...Index 2MF Users Guide 1 6...

Page 19: ...is one tool for measuring blood pressure When our blood pressure is taken it is measured at the brachial artery in the forearm in millimeters of mercury mmHg If our blood pressure reading is at or nea...

Page 20: ...led oxyhemoglobin HbO2 SAT to unsaturated or reduced hemoglobin Hb The arterial oxygen saturation SaO2 is defined as the ratio of the concentration of oxyhemoglobin cHbO2 to the concentration of HbO2...

Page 21: ...he true SaO2 value To do so pulse oximeters use a system that distinguishes between AC components the pulsating arterial blood and DC components the non pulsating components mentioned just above Figur...

Page 22: ...Oximeters B Hannhart et al Neonatal Intensive Care Nov Dec 1991 Clinical Pulse Oximetry Thomas L Petty MD Anesthesiology v 70 no 1 Jan 1989 Oximetry Blood Gas Medical Electronics Oct 1989 The Concise...

Page 23: ...l testing simulations are output through the electrical port on the back of the Simulator thus eliminating the probe from the circuit FBC makes specific cables to connect the electrical port on the Si...

Page 24: ...rs or repeatability of simulations better than 1 is mandatory The Simulator repeatability is conservatively specified at better than 1 standard deviation In Fluke Biomedical s experience with oximeter...

Page 25: ...t selected R curve esl009 eps Note If at power up the batteries are low and in need of recharging the message WARNING BATTERY LOW appears on the LCD The Main Menu 1 The Main Menu 1 choices give you ac...

Page 26: ...the menu displaying the following O2 to set up Sp02 alarm limits level and response time BPM to set up rate alarm limits and response time AMP to select pulse amplitude limits ASYS to set up asystole...

Page 27: ...oximeter type by make configure the Simulator serial RS232 port and adjust the contrast of the LCD screen fgg161 eps The choices available at the Main Menu 2 include AUTO to create and run tailored t...

Page 28: ...Index 2MF Users Guide 4 4...

Page 29: ...s you will be testing The Simulator stores the definitions for different makes of pulse oximeters You can change variables for each of the pulse oximeter types to match the devices you will be testing...

Page 30: ...urn to Main Menu 1 press the softkey more Verified Oximeter Makes The following makes of oximeters have been verified as working properly both electronically and with their probes and are pre programm...

Page 31: ...These six profiles may be changed at the Download Make menu by selecting Make at Main Menu 2 Additionally five CUSTOM R Curves can be stored in the Simulator Refer to Appendix E Computer Control for...

Page 32: ...nics 93 80 Once a technology and a curve have been determined save the custom make for future use Operation To access the custom menu press CUST from the main menu Chose the slot to customize by press...

Page 33: ...and gives stable readings at low and high oxygen levels note these readings as seen on the oximeter and refer to the R Curve list in Table 5 2 Find a high level and low level that are similar to your...

Page 34: ...Index 2MF Users Manual 5 6...

Page 35: ...t an oximeter and determine its weaknesses if any The Simulator will display and optionally print areas in your pulse oximeter performance that may be unacceptable and document correct performance The...

Page 36: ...conditions including A normal patient A patient with a weak pulse An obese patient A geriatric patient A bradycardic patient one with an abnormally slow pulse below 60 BPM A tachycardic patient one w...

Page 37: ...h a pulse of 75 beats per minute To change either of these settings press MAN on the Simulations Menu fgg031 eps The manual settings screen appears on the LCD displaying the current SpO2 and BPM esl03...

Page 38: ...the appropriate softkey s as many times as needed to adjust the BPM Returning to Main Menu 1 To return to the Main Menu press esc twice Using Preset Patient Conditions The Simulator preset feature com...

Page 39: ...Neonate Shiver 90 180 BPM 1 0 70 6 0 Hz 5 12 Tachycardia 85 130 BPM 1 2 0 13 Geriatric 92 95 BPM 2 4 0 14 Obese 93 90 BPM 3 0 0 15 Brady Tap 2 88 45 BPM 5 0 96 100 3 9 Hz 0 4 16 Hypox Tap 2 70 95 BPM...

Page 40: ...ey PRESET esl039 eps The values preset at the factory appear on the LCD screen esl040 eps 3 Press the softkey under the or to scroll through and select from the available presets 4 Return to the Main...

Page 41: ...d infrared pulses Artificial 50 Hz Hz Hertz is the frequency of the light measured in cycles per second Artificial light is simulated by superimposing 50 Hz noise on the pleth wave Artificial 60 Hz Si...

Page 42: ...Main Menus With the Simulation option MAN manual submenu With the LMTS limits option 02 02 Alarm and BPM Rate Alarm submenu With the AUTO Autosequence menu s PROG submenu for setting SpO2 level and p...

Page 43: ...d limits are reached during the testing of your pulse oximeter From the Main Menu 1 press the LMTS softkey fgg011 eps The following menu appears in the LCD esl049 eps Note Exit this menu with the soft...

Page 44: ...lations menu without affecting the timing function Pressing the softkey minus will decrease by the step amount without affecting the timing function Note Continue pressing or until the O2 percent you...

Page 45: ...Response Time 13 0 sec 5 When you are finished testing the pulse oximeter for SpO2 readings press esc to return to the Limits menu esl055 eps Simulating the Pulse Rate The Simulator simulates a varie...

Page 46: ...ressing the softkey minus will decrease by the step amount without affecting the timing function The Simulator displays the message Timing and maintains an internal timer until you press STOP or the o...

Page 47: ...ttached you will see results that look something like this example Rate Alarm Response Time 10 0 sec Press esc to return to the Limits menu esl061 eps Simulating Pulse Amplitude The peak to peak ampli...

Page 48: ...From 1 to 0 1 the value will decrease by 0 1 Below 0 1 the value will decrease by 0 025 per button press Inputs below 6 are rounded internally to the nearest 0 024 and above 6 are rounded to the near...

Page 49: ...mulating Asystole or No Pulse In a clinical setting a no pulse condition is life threatening Most pulse oximeters sound alarms in response to this condition The Simulator can measure the response time...

Page 50: ...patible PC including laptops and notebooks 5 To print the results of the test for review or archiving press PRT esl072 eps Selecting PRT sends results to the RS232 and Centronics ports With a printer...

Page 51: ...defined program the Simulator will run through the tests one by one at the settings you determine and for the time for each test that you specify You are only prompted to press a button to begin each...

Page 52: ...rough PROG13 for the name or you can enter any name of up to eight characters in length The name can include letters A Z numbers 0 9 and spaces Print Heading Set whether you want the heading page to p...

Page 53: ...itude test Motion Test Set the Simulator to test the oximeter for patient motion Use Presets Set the Simulator to allow for the selection of preset patient conditions geriatric obese normal etc at tes...

Page 54: ...efault factory settings esl078 eps Creating a Custom Test Program Autosequence Setting up a custom program in requires a few simple steps access the Autosequences menu enter or select a program name d...

Page 55: ...utosequences screen appears on the LCD with the Sequence indicating the current program in this instance Program 0 esl082 eps You can then modify one of the pre programmed test programs from PROG0 thr...

Page 56: ...edit the program name press NAME esl085 eps The LCD screen shows the program name for the last program used or PROG 0 the first time the Simulator is powered up esl086 eps 2 The cursor blinks over the...

Page 57: ...e below until you reach the letter L notice that the R is now an L esl087 eps 6 Or press to increase the letter or number in sequence as shown below notice that the L is now an O esl088 eps 7 When you...

Page 58: ...Autosequences menu and will prompt you to save or not save your program from there pressing esc returns you to the Main menu Selecting Print Settings You can customize a program to include optional he...

Page 59: ...ance through the O2 and rate level settings for each test 1 After selecting a test set the oxygen level for test number one esl095 eps 2 Press or to adjust the simulated oxygen level up or down for th...

Page 60: ...the Simulation Cycle Oximeters require a fixed number of cycles to evaluate and respond to a change in input You can set the expected response time in waveform cycles after which the Simulator will be...

Page 61: ...the Simulator for a specific make of oximeter refer to Chapter 5 esl101 eps Once you have selected the oximeter make press the softkey ADV to continue esl102 eps Choosing Your Tests Your next step in...

Page 62: ...screen press ADV to continue esl106 eps Selecting Pulse Amplitude Press SEL to toggle the Pulse Amplitude response from NO to YES as needed esl107 eps When you are done or to simply bypass this scree...

Page 63: ...ypes normal weak heart obese or geriatric for example esl110 eps 2 When you are done or to simply bypass this screen press ADV to continue which returns you to the Sequence menu esl111 eps Saving Your...

Page 64: ...esl115 eps If you press NO you will be returned to the Autosequences menu without saving the new program or without saving modifications to an existing program whichever applies esl116 eps Running an...

Page 65: ...n displays the message Program 2 Complete and presents the option of printing the results as well as the number of copies to print 4 Press esc to return to the Run screen Press esc again to return to...

Page 66: ...efaults for the listed program esl123 eps If you selected ALL the LCD flashes the message Loading defaults Please Wait until restoration is complete the Simulator returns to the Restore program screen...

Page 67: ...meter probes can be tested by the Simulator but will require special care in preparation of an adapter cable and interpretation of the results Damage could occur to the Simulator or the oximeter probe...

Page 68: ...initiates a testing sequence that includes Verifying that a Probe Test Board is installed in the Simulator Checking whether or not a probe adapter cable is connected to the probe port Performing all m...

Page 69: ...shorted diode while 4 0 V would indicate either an open diode or that the voltage drop across the diodes has exceeded the Simulator s forward voltage test range Photodiode Test This test looks at the...

Page 70: ...ll fluctuate unless you take care to maintain the optimal mechanical position of the probe As a suggestion wrap the disposable probe on a small white plastic cylinder or tube not your finger to mainta...

Page 71: ...Electrical Probe Test Probe Test Selection 9 9 5 esl129 eps Note These values do not update continually Use REDO when checking for intermittent connections...

Page 72: ...Index 2MF Users Guide 9 6...

Page 73: ...same as setting an ambient light artifact sunlight artificial light for oximeter testing under the Simulations menu The steps outlined here allow adjusting the screen contrast on the LCD itself LCD C...

Page 74: ...For information on RS232 CKSM and PTST functions refer to Appendix A Printing and Data Transfer Pressing esc will return you to Main Menu 2 3 Press DISP to access the LCD controls fgg134 eps The LCD...

Page 75: ...is 0 5 Press softkey to decrease the LCD contrast esl137 eps Note The third and fourth keys are not activated for LCD contrast adjustment 6 When the LCD contrast is acceptable press esc to return to...

Page 76: ...Index 2MF Users Guide 10 4...

Page 77: ...communications ports with the unit under test connected via a second communications port You send special commands to the Simulator using the computer the Simulator then acts on the commands to test a...

Page 78: ...Refer to Appendix A Printing Data Transfer for information on the RS232 port and how to set communications parameters baud rate and parity settings Mathematical Background The Simulator assumes that a...

Page 79: ...value set The default value here is 1 000 Red light ac rac and infrared light ac irac are true attenuations A value of 1 000 for example means that the pleth wave will attenuate the UUT pulse by appro...

Page 80: ...independent of finger thickness and pigmentation Note By varying the ac term you can determine the oximeter s ability to track and hold a pleth wave as it weakens to zero and then re acquire the wave...

Page 81: ...nd will use instead a fixed dc level for infrared and red pulse simulations esl148 eps The signals will pass through the Simulator based on their original amplitude 4 To return to the Advanced Options...

Page 82: ...t the cursor under the step digit that you want to adjust The cursor flashing in the digit field highlights first 0 in the sample above of 0 020 Advance to the next digit position by pressing esl152 e...

Page 83: ...m Light Download Slot 3 Medium Light Download Slot 4 Medium Light Download Slot 5 Low Light Download Slot 6 Low Light It is important that you save the R Curve for the manufacturer in the correct ligh...

Page 84: ...5 Continue recording R values until SpO2 50 Downloading an R Curve into the Simulator 1 Create an ASCII file with the numbers obtained on the data sheet The file should look like this rcurve 2 N 10 25...

Page 85: ...lse Oximeter Verified On Probe Used Heart Rate Used R Curve Downloaded in Position Number Notes ___ ________________________________ ___________________________________________________________________...

Page 86: ...Index 2MF Users Guide 12 4...

Page 87: ...Data Transfer A 1 B Error Messages and Corrective Measures B 1 C Accessories List C 1 D Specifications D 1 E Computer Control E 1 F Typical Questions and Answers F 1 G Custom Probe Test Cables and El...

Page 88: ...Index 2MF Users Guide...

Page 89: ...offers a bi directional serial null modem cable for connect the Simulator to your computer IBM compatible or serial printer Please specify Fluke Biomedical Part Number 2238626 when ordering 1 C Lock 2...

Page 90: ...specify Fluke Biomedical Part Number 2238072 when ordering Configuring the Serial RS232 Port Configure the Simulator to match your printer s or computer s communications needs by setting baud rate an...

Page 91: ...Accessing the Utilities Menu 1 Press UTIL on the the Simulator Main menu 2 first press more if you are viewing Main Menu 1 fgg014 eps You will see the following menu appear in the Simulator s LCD dis...

Page 92: ...h press of the button decreases the baud rate from 9600 to 2400 1200 600 and 300 bps When 300 is displayed a button push then shows 9600 PAR Pressing this button toggles the parity from No parity N to...

Page 93: ...Ver 2 00 Control __________________________ Serial __________________________ Model _____________________________ Mfr _______________________________ Location __________________________ Technician __...

Page 94: ...Index 2MF Users Guide A 6...

Page 95: ...er of times after which it needs to be replaced To recharge the battery plug the battery charger that came with the Simulator into the Simulator charger jack and plug the battery charger into a wall s...

Page 96: ...isplay reads NO RED LED NO IRED LED Check probe or press esc The LEDs on the Pulse Oximeter must be positioned on the bottom of the Simulator s finger probe attachment Make sure the Pulse Oximeter s f...

Page 97: ...er s Guide and a battery charger U S or European are standard equipment Table C 1 Accessories Description Part Number Index 2MF User s Guide 3341210 Carrying Case 2204282 Charger USA 2521465 RS232 Cab...

Page 98: ...Index 2MF Users Guide C 2...

Page 99: ...least 4 hours of continuous use Battery Charger Type Lead Acid battery charger only Input 100 250 V 60 60 Hz 0 3 A Output 12 V dc 0 5 A Probe Test Index 2MFE version only Continuity Resistance Test T...

Page 100: ...een the two LEDs constant current level at 1 0 mA Test Results Nominal range of 0 to 20 000 Checksum The sum of all locations in the program chip For service only Note The above specifications are for...

Page 101: ...d version Software version number and copyright years Make of last selected test equipment Main Menu 1 screen esl009 eps 2 Connect the Simulator to the computer by connecting the RS232 cable to both t...

Page 102: ...example shown here esl166 eps Command Syntax Computer commands sent to the Simulator must observe a standard format Command start Command end Command Variable input XXX esl156 eps Commands are case i...

Page 103: ...waveform with an ECG monitor The signal is 0 to 5 volts limited by 4 7k and can be synchronized to any part of the pleth waveform Available at Pin 1 of the RS232 port 0 to 65 CPHASE45 HIRES 1 n nnn A...

Page 104: ...PLAYER PRESETS nn Selects a specific preset where nn ranges from 00 to 23 A range of 00 to 23 for nn corresponds to preset motion selection shown in the presets in Table 6 2 00 to 23 PRESETS 05 PROBE...

Page 105: ...t Description RCURVE Identifies this to computer control as an R curve data stream 3 The curve number Range is 0 to 5 There are six total downloadable R curves The colon is a field separator Pulse oxi...

Page 106: ...mmand end designator LD BAT File Both SHAPE and RCURVE commands can be downloaded from the computer to the simulator using the LD BAT program detailed below This program requires that MODE COM be in t...

Page 107: ...oaded through the Simulator s serial port and loaded directly into the red AC and infrared AC digital to analog converters DACs The output waves of the DACs are controlled by the amplitude values and...

Page 108: ...the PC in DOS mode Some PCs have a conflict with driver files This conflict appears to be resolved when the PC is actually booted in DOS mode versus opening a DOS box from Windows To stop the playbac...

Page 109: ...Index 2MF finger probe attachment and their photo diodes can placed over the LED output of the Index 2MF finger probe attachment 3 How should probes be positioned on the Index 2MF finger probe attachm...

Page 110: ...robes it is difficult to ensure consistent alignment of the LEDs to the photo detector This could also be a problem when using a disposable probe on a patient 5 I cannot find the make of the pulse oxi...

Page 111: ...The curves were then verified on several pulse oximeters of that brand It is possible to download additional R curves to Index 2MF as needed for pulse oximeters that are not preprogrammed into Index 2...

Page 112: ...Index 2MF Users Guide F 4...

Page 113: ...E can be used to test probes using custom probe adapter cables Figure G 1 shows a typical oximeter probe It consists of two LEDs and one photodiode In addition it may also contain an LED spectrum char...

Page 114: ...LEDs IR R esl159 eps Figure G 1 Typical Oximeter Probe The Simulator is designed to find all these failure modes Note as shown in Figure G 2 that the LEDs may be connected in one of four ways 1 Back...

Page 115: ...or is designed to work with an interface cable that adapts the Simulator connector to the probe connector If you need to test a probe which is not supported by Fluke Biomedical at this time with an in...

Page 116: ...s this resistor to determine the LED connection being tested Examining the 15 pin connector further 1 Up to two LED calibration resistors can be tested by the Simulator Connect them as R1 and R2 in Fi...

Page 117: ...Cables and Electrical Simulation Cables G G 5 Example Ohmeda Probe Test Index 2 Pin 1 2 3 4 5 6 8 7 1 2 3 4 5 6 8 7 9 9 10 11 12 13 14 30 k 1 15 R ID Res Common IR Ohmeda Probe Pin esl168 eps Figure G...

Page 118: ...is not exhaustive but you should be familiar with all of the electronic details of The oximeter LED drive circuit How the oximeter decides if a probe is present Whether the photodiode input amplifier...

Page 119: ...8 9 esl162 eps Figure G 4 Generic Pins by Usage Pins 1 through 4 show the different ways oximeter probes can have their LEDs connected For example if the Simulator were used to simulate an Ohmeda prob...

Page 120: ...istors as noted in Figure G 5 Normally oximeter shield pins should not be tied to the Simulator ground but there may be exceptions Again only a thorough study and understanding of the oximeter interfa...

Page 121: ...ric current in the meter kilogram second system It is the steady current that when flowing in straight parallel wires of infinite length and negligible cross section separated by a distance of one met...

Page 122: ...od within the arteries primarily maintained by contraction of the left ventricle BPM Beats per minute See pulse bradycardia A cardiovascular condition characterized by an abnormally slow heartbeat of...

Page 123: ...eter The fundamental unit of length equivalent to 39 37 inches in the metric system Originally defined in 1790 as one ten millionth 107 of the earth s quadrant passing through Paris the meter was rede...

Page 124: ...g peripheral devices to computers using either a 25 pin connector or a 9 pin connector Generally speaking personal computers are data terminal equipment DTE devices and peripherals such as printers mi...

Page 125: ...and contracts to drive it into the aorta and b the chamber on the right side of the heart that receives venous blood from the right atrium and drives it into the pulmonary artery volt 1 The Internati...

Page 126: ...Index 2MF Users Guide H 6...

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