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Fluke Biomedical Index 2MF User Manual

Fluke Biomedical Index 2MF User Manual

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Index 2MF
SpO2 Simulator
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 respective companies.

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  • Page 1 Index 2MF SpO2 Simulator 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 respective companies.
  • Page 2 Fluke Biomedical. This warranty does not apply if the product has been damaged by accident or misuse or as the result of service or modification by other than Fluke Biomedical. IN NO EVENT SHALL FLUKE BIOMEDICAL BE LIABLE FOR CONSEQUENTIAL DAMAGES.

  • Page 3: Unpacking And Inspection

    Copyright Release Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications. If you would like other reproductions or distributions, submit a written request to Fluke Biomedical.

  • Page 4: Return Procedure

    No responsibility is assumed by Fluke Biomedical for the use or reliability of software or equipment that is not supplied by Fluke Biomedical, or by its affiliated dealers.

  • Page 5: Table Of Contents

    Table of Contents Chapter Title Page Introducing the Index 2MF..............1-1 Capabilities ......................1-1 Index 2MF Compatibility .................. 1-1 Index 2MF Features ................... 1-2 Package Contents....................1-2 F Version ....................... 1-2 FE Version..................... 1-2 Registration Card................... 1-2 Precautions......................1-2 Electromagnetic Interference and Susceptibility ..........1-3 EC EMC Directive 89/336/EEC..............
  • Page 6 Index 2MF Users Guide Evaluating Test Results ..................3-2 Simulator Functionality ..................3-2 The Main Menus .................. 4-1 Introduction......................4-1 The Main Menu 1 ....................4-1 The Main Menu 2 ....................4-3 Configuring the Simulator ..............5-1 Configuring for Specific Oximeter Make ............5-1 Accessing the Make Menu.................
  • Page 7 Contents (continued) Selecting Pulse Amplitude ................ 8-12 Selecting Motion ..................8-12 Selecting Presets..................8-13 Saving Your Program ..................8-13 Running an Automatic Test Program ..............8-14 Returning an Automatic Test Program to Default State ........8-15 Electrical Probe Test ................9-1 Electrical Probe Testing..................
  • Page 8 Index 2MF Users Guide...
  • Page 9 List of Tables Table 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 Test Parameters ..................8-2...
  • Page 10 Index 2MF Users Guide...
  • Page 11 List of Figures Figure Title Page 2-1. Sphygmomanometer ....................2-1 2-2. Formula 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: Introducing The Index 2Mf

    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 Fluke Biomedical's superior support system. If the Simulator ever fails to work perfectly, please refer to the phone, fax, and Internet numbers at front of this book to contact Fluke Biomedical's Technical Support Staff.

  • Page 14: Index 2Mf Features

    Ohmeda and Nellcor Probe and Oximeter Adapter (electrical cables) Registration Card Once the the Simulator is successfully up and running, complete the postage-paid registration card and mail it to Fluke Biomedical. Precautions Observe these precautions when using the Simulator; like any electronic equipment, it should be adequately protected both when moving and in storage.

  • Page 15: Electromagnetic Interference And Susceptibility

    Introducing the Index 2MF Electromagnetic Interference and Susceptibility The Simulator battery life can be seriously shortened by leaving the instrument turned on for many hours after the low battery alarm sounds. To avoid damage: Package and handle the Simulator to ensure that the power switch cannot accidentally turn on during shipment.

  • Page 16: Canadian Department Of Communications Class A

    Index 2MF Users Guide equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area could cause interference, in which case the user will be required to correct the interference.

  • Page 17: Using The Optical Finger Probe (All Versions)

    Note If you see a message warning you that your battery is low, you need to attach the battery charger. Call Fluke Biomedical for assistance if needed. Toggle between Main Menu 1 and Main Menu 2 with the more softkey.
  • Page 18 Index 2MF Users Guide...

  • Page 19: Blood Oxygen And Pulse Oximeters

    Chapter 2 Blood Oxygen and Pulse Oximeters Blood Pressure Blood pressure readings provide valuable information about the condition of our bodies, indicating health or the lack of it. As the heart contracts (systole) and relaxes (diastole), the volume of freshly-oxygenated blood increases and decreases measurably within the artery walls.

  • Page 20: Pulse Oximeters

    Index 2MF Users Guide dioxide (CO 2 ), can be expressed as milliliters of gas per liter of blood, and can be indicated by the partial pressure that the gases exert in your blood at a given temperature. Pulse Oximeters Because of their ease of use in many hospital- and critical-care situations, pulse oximeters have greatly increased in popularity since their introduction.
  • Page 21 Blood Oxygen and Pulse Oximeters Pulse Oximeters Figure 2-3 shows a typical pulse oximeter configuration, noting the location of the red and infrared LED's. 940nm Infrared LED 660nm Red LED Photosensor esl005.eps Figure 2-3. Diagram of Sample Finger Probe for a Typical Pulse Oximeter Using this dual light emitting and sensing technology, the pulse oximeter determines the amount of light absorbed by the blood and calculates the percent of oxygen saturation (SaO 2 ).

  • Page 22: References

    Index 2MF Users Guide 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.

  • Page 23: Index 2Mf Overview

    Chapter 3 Index 2MF Overview The Index 2MF "Finger" The Simulator system has a patented optical “finger” that takes the place of an actual patient's index finger. This finger works with any pulse oximeter that detects SpO 2 (Saturation of Peripheral Oxygen) through the index finger (as opposed to the earlobe or toe) tissue.

  • Page 24: Evaluating Test Results

    (or an identical one). Fluke Biomedical has measured the operational characteristics of different makes of oximeters, all believed to be properly calibrated and operating correctly. Users access these measurements when selecting an oximeter make for testing.

  • Page 25: The Main Menus

    Chapter 4 The Main Menus Introduction When you first turn on the Simulator, it sequentially displays the following screens for about one second each before ending with the Main Menu 1 screen: Bio-Tek Instruments Inc. and model number and version Software version number and copyright years Make of last selected R-curve esl009.eps...
  • Page 26 Index 2MF Users Guide fgg010.eps Selecting SIM opens the menu displaying the following: MAN to run manual simulations PRESET to run factory-defined simulations AMB to set ambient light levels CUST to create custom makes esc softkey to return to Main Menu 1 LMTS lets you set the alarm limits for oxygen, beats per minute, pulse amplitude, and lets you set up a timer for asystole.

  • Page 27: The Main Menu 2

    The Main Menus The Main Menu 2 fgg013.eps The CUST menu options are for creating custom makes by choosing a light technology and R-Curve. This custom make can be stored for later use. Custom makes are used when the pulse oximeter being tested is not in the factory preset makes. The Main Menu 2 The softkey more toggles between Main Menu 1 and Main Menu 2.
  • Page 28 Index 2MF Users Guide...

  • Page 29: Configuring The Simulator

    Chapter 5 Configuring the Simulator Configuring for Specific Oximeter Make Light technology and R-Curve data must be known in order to test a pulse oximeter, optically via finger or electrically. You can configure the Simulator to match the make of pulse oximeter(s) you will be testing.

  • Page 30: Verified Oximeter Makes

    (CardioCap, Ultima, Satellite Trans, AS/3, 251) ® (Merlin) ® Masimo ® Nellcor (N-100, 200) ® Nihon-Kohden (Lifescope) ® Ohmeda (3700) and Nova ® Respironics R-Curve Specifications Fluke Biomedical, in cooperation with the manufacturers, developed the R-Curves for the devices listed previously.

  • Page 31: Customizing A Make Not Included Within Index 2Mf

    Customizing a Make Not Included Within Index 2MF Note The cooperative venture does not represent an endorsement of Index 2MF by these manufacturers. Fluke Biomedical assumes the responsibility for the R-Curves, and any results obtained from the use of Index 2MF. Note Some oximeters utilize technology and probes licensed from other manufacturers.

  • Page 32: Operation

    Index 2MF Users Manual Note The Simulator accuracy specifications are not valid for user defined custom makes. The Simulator can provide specified repeatability of 1 standard deviation. Table 5-1. Oximeters with Technology Options Technology Options Typical Oximeters Normal Intensity Nellcor, BCI Low Intensity Hewlett-Packard, Ohmeda, Invivo High Intensity...
  • Page 33 Configuring the Simulator Operation The beeper sounds and the menu changes to HiOx. With the oximeter probe connected to the Simulator, look for a steady reading on the oximeter. The number may be in the low 90s, but not necessarily. If the oximeter is not displaying a stable number, change technology types again to find a stable reading.
  • Page 34 Index 2MF Users Manual...

  • Page 35: Setting And Changing Simulation Factors

    Chapter 6 Setting and Changing Simulation Factors About Simulations and Presets One of the main functions of the Simulator is to test the performance of a pulse oximeter for any possible patient condition. The Simulator allows you to set any combination of blood-oxygen levels, heart rates, and pulse amplitude, as well as simulate a virtual range of medical physical conditions and set an ambient light artifact.
  • Page 36 Index 2MF Users Manual Note Do not connect the MFE version to two pulse oximeters simultaneously. The simulator must synchronize with Red and IR signals from only one oximeter. fgg030.eps Additional settings become available in the Simulations menu, as detailed in Table 6-1. Table 6-1.

  • Page 37: Changing The Default Spo 2 Setting

    Setting and Changing Simulation Factors Setting Simulations Changing the Default SpO 2 Setting The default settings (for the current session from power-up, when no prior changes have been made) are for a simulated patient with 96% saturated oxygen levels and with a pulse of 75 beats per minute.

  • Page 38: Raising Or Lowering The Pulse Rate

    Index 2MF Users Manual 3. Press the softkeys to raise (O2+) or lower (O2-) as many times as needed to adjust the SpO 2 level. Raising or Lowering the Pulse Rate The Simulator also lets you adjust the pulse, for a customized virtual patient. 1.
  • Page 39 Setting and Changing Simulation Factors Using Preset Patient Conditions Table 6-2. Level 0 Presets Motion Pulse Signal Preset Name Saturation [presets#] Rate Strength Saturation Frequency Amplitude Normal 98 % 55 BPM 5.0 % Normal/ Tap 98 % 55 BPM 5.0 % 78 % 2.5 Hz Normal/ Shiver...
  • Page 40 Index 2MF Users Manual fgg010.eps The Simulations menu appears in the LCD screen: fgg038.eps 2. To view the preset patient condition, press the softkey 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.

  • Page 41: Setting The Light Artifact

    Setting and Changing Simulation Factors Setting the Light Artifact Setting the Light Artifact You can set a light artifact with the Simulator to test oximeters under different simulated ambient (surrounding) light conditions. The available simulations are as shown in Table 6-3.

  • Page 42: Setting 0 2 And Pulse Rate Step Size

    Index 2MF Users Manual 3. Once you have selected an ambient light setting, you can return to the Simulations menu by pressing esc. Press esc again to return to Main Menu 1. Setting 0 2 and Pulse Rate Step Size You can vary the size of the steps for O 2 and pulse rates used when setting up tests and testing oximeters with the Simulator.

  • Page 43: Testing The Pulse Oximeter Limits

    Chapter 7 Testing the Pulse Oximeter Limits Introduction Once you have determined the range in which you want to test a pulse oximeter for SpO 2 and rate, you can test the pulse oximeter for upper and lower limits for response time. Testing Pulse Oximeter Limits You can set your oximeter to sound an alarm whenever any pre-determined limits are reached during the testing of your pulse oximeter.
  • Page 44 Index 2MF Users Manual esl049.eps The display changes to present these options: esl051.eps When setting new oxygen limits, the Simulator displays the last setting used (or 96% if not previously changed) and resets the time to 00.0 seconds. 2. Press the softkeys + or - to start the timer, and the screen displays the “Timing!” message.

  • Page 45: Simulating The Pulse Rate

    Testing the Pulse Oximeter Limits Simulating the Pulse Rate esl054.eps The results will be sent out the RS232 and the Centronics ports to an attached printer. Note You can connect the Simulator to any printer with a serial or parallel Centronics-type port or to any IBM-compatible PC, including laptops and notebooks.
  • Page 46 Index 2MF Users Manual esl057.eps Note Notice, as with most menus, the last softkey, esc, will always return you to the previous menu, in this case the Limits menu. When setting a new BPM limit, the Simulator always starts with the last pulse rate setting.

  • Page 47: Simulating Pulse Amplitude

    Testing the Pulse Oximeter Limits Simulating Pulse Amplitude esl060.eps The results will be sent to the RS232 and Centronics port. Note Connect the Simulator to any printer with a serial port or parallel Centronics port, or to any IBM-compatible PC, including laptops and notebooks.
  • Page 48 Index 2MF Users Manual esl063.eps 3. To raise the Pulse Amp percentage (AC factors) in the simulated blood condition, press the softkey +: esl064.eps The amplitude will increase in increments of 1% with every softkey press. 4. To lower the percentage of AC factors in the simulated blood condition, press the – softkey: esl065.eps The amplitude will decrease by 1% with every softkey press down to 1 %.

  • Page 49: Simulating Asystole Or No Pulse

    Testing the Pulse Oximeter Limits Simulating Asystole or No Pulse Note You can connect the Simulator to any printer with a serial port or parallel Centronics-style port or to any IBM-compatible PC, including laptops and notebooks. For information on how to connect to other systems or peripherals, see “Appendix A: Printing &...
  • Page 50 Index 2MF Users Manual When the alarm sounds, press the softkey STOP. esl071.eps The timer ceases counting and the elapsed time (in seconds) displays on the screen. Note You can connect the Simulator to any printer with a serial or parallel Centronics-style port or to any IBM-compatible PC, including laptops and notebooks.

  • Page 51: Using Test Programs

    Chapter 8 Using Test Programs The AUTO Menus The Simulator provides several pre-defined test programs to automatically sequence tests. You would ordinarily have to manually set each test parameter every time you start the Simulator and connected it to a pulse oximeter for testing. Pre-defined test programs save you time, allowing you to avoid resetting test parameters for every pulse oximeter testing session.

  • Page 52: The Program Definition Cycle

    Index 2MF Users Guide The Program Definition Cycle Figure 8-1 shows in a simple, graphic way, the steps involved in creating a custom program. 1. Select and name the program. 6. Save the 2. Set oxygen program. and pulse rate levels 3.

  • Page 53: Accessing The Autosequences Menu (Auto)

    Using Test Programs The AUTO Menus Table 8-1. Auto Test Parameters (cont.) Name Description Make Set the make of machine being tested, such as Nellcor, HP, Criticare, Ohmeda, Invivo Research, and so on. O 2 Alarm Test Set the Simulator to either test or bypass the SpO 2 limits test. BPM Alarm Test Set the Simulator to either test or bypass the BPM units test.

  • Page 54: Creating A Custom Test Program (Autosequence)

    Index 2MF Users Guide PROG lets you define or edit a set of program parameters that you can have run automatically when needed. esl076.eps Press the softkey RUN to run any of the up to fourteen autosequences (pre-defined test programs). esl077.eps Pressing the softkey DEFS lets you restore any or all of the programs to their default factory settings.

  • Page 55: Selecting A Test Program

    PROG13. The screen displays the last program selected, for example, if you were last using Program 5, the Simulator displays PROG 5 when you select PROG. PROG0 through PROG13 are identical as shipped from Fluke Biomedical. To scroll through the list of programs (in ascending alphanumeric order), press...

  • Page 56: Optionally Renaming The Test Program

    Index 2MF Users Guide esl083.eps To scroll through the list of programs (in descending alphanumeric order), press softkey - (minus sign). esl084.eps Optionally Renaming the Test Program You can rename any of the test programs. The name can be from one to eight characters in length, containing letters, numbers, and spaces;...
  • Page 57 Using Test Programs Creating a Custom Test Program (Autosequence) 4. The name is limited to eight characters maximum. Continuing to press the softkey eventually returns the cursor to the first character. 5. In the example below, the second position was changed (the letter “R” in PROG 1). Press - to decrease the letter or number as in the example below until you reach the letter L (notice that the R is now an L).

  • Page 58: Configuring The Program

    Index 2MF Users Guide Configuring the Program From the Sequence menu, re-configure the parameters and values in a program, which may include everything from BPM to oximeter model being tested; this section details resetting those program’s values and parameters. Press ADV to begin defining your program. esl091.eps Note At any time during the program-definition process, you can press esc and...

  • Page 59: Setting The 0 2 Level

    Using Test Programs Creating a Custom Test Program (Autosequence) esl094.eps 3. Press SEL to change the Include Actuals: response from YES to NO as needed. 4. Move to the next step in the process by pressing the softkey ADV. Setting the 0 2 Level You can set up to ten different oxygen levels and up to ten different pulse rates for the simulation autosequences.

  • Page 60: Setting The Simulation Cycle

    Index 2MF Users Guide esl097.eps 2. Press NEXT to set the pulse rate for each additional rate test, if required. You can set up to ten rate tests. Pressing NEXT at Rate Setting # 10 brings you back to O2 Setting #1.

  • Page 61: Selecting The Make

    Using Test Programs Creating a Custom Test Program (Autosequence) esl100.eps Selecting the Make Next, select the make of the pulse oximeter that you will be testing. Press to scroll up and down the list of pre-programmed oximeter types. For more information on configuring the Simulator for a specific make of oximeter, refer to Chapter 5.

  • Page 62: Selecting Pulse Amplitude

    Index 2MF Users Guide esl104.eps 3. Next, press SEL to change the Rate Alarm Test response from NO to YES, or YES to NO, as needed. esl105.eps 4. When you are done (or to simply bypass this screen), press ADV to continue. esl106.eps Selecting Pulse Amplitude Press SEL to toggle the Pulse Amplitude response from NO to YES, as needed.

  • Page 63: Selecting Presets

    Using Test Programs Creating a Custom Test Program (Autosequence) 2. When you are done (or to simply bypass this screen), press ADV to continue. esl109.eps Selecting Presets Next, select if the pre-programmed patient types will be used.. 1. Press SEL to use pre-programmed patient types (normal, weak heart, obese, or geriatric, for example).

  • Page 64: Running An Automatic Test Program

    Index 2MF Users Guide esl113.eps 3. Press YES to save your program, or NO to skip. esl114.eps If you press YES, you will see a message indicating your program is being saved: 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...

  • Page 65: Returning An Automatic Test Program To Default State

    Using Test Programs Returning an Automatic Test Program to Default State At the RUN screen, use to display the program to be run, if it is not the first program automatically displayed. esl118.eps 2. To run the displayed program, press the softkey START. esl119.eps The program will prompt you as needed to press ADV to move from test to test.
  • Page 66 Index 2MF Users Guide 2. Use to locate the program you want to reset, if it is not the first program automatically displayed. Or, use ALL to restore defaults for all autosequence programs. esl122.eps 3. Press OK to reset the defaults for the listed program. esl123.eps If you selected (ALL), the LCD flashes the message “Loading defaults - Please Wait…”...

  • Page 67: Electrical Probe Test

    Chapter 9 Electrical Probe Test Electrical Probe Testing Fluke Biomedical has validated that the following oximeter probes can be functionally tested using the Simulator (MFE Version only) when connected via the correct probe cable adapter: BCI® ( 3101) Criticare® (504) Datascope®...

  • Page 68: Probe Test Selection

    Index 2MF Users Guide Note The MFE version ships with Nellcor and Ohmeda probe and oximeter adapters. Please contact Fluke Biomedical regarding the availability of additional adapter cables. W Caution Attempting to create adapter cables without all details of the oximeter probe-operating scheme could result in damage to the oximeter, the Simulator, or both.

  • Page 69: Photodiode Test

    Electrical Probe Test Probe Test Selection esl126.eps The Simulator applies 1.0 mA current AC signal source to the red and infrared LEDs. The Simulator performs the electrical test separately on each diode to confirm they are functioning properly. The voltage drop across each element is measured and displayed. Values can range from 0.0 to 4.0: 0.0 Volts = LED shorted 1.4 +/- Volts = LED OK...

  • Page 70: Resistance Testing

    Index 2MF Users Guide Develop baseline values for comparison purposes when testing marginal, defective, or suspect probes by logging voltage readings from operational probes. These values update continually during testing. esl128.eps Note During the photodiode test, the finger probe being tested should not be attached to the Index 2MF finger.
  • Page 71 Electrical Probe Test Probe Test Selection esl129.eps Note These values do not update continually. Use REDO when checking for intermittent connections.
  • Page 72 Index 2MF Users Guide...

  • Page 73: Adjusting The Lcd Screen

    Chapter 10 Adjusting the LCD Screen Introduction Users may adjust the liquid crystal display (LCD) screen, increasing or decreasing the contrast to accommodate different ambient lighting situations. Note This function is not the same as setting an ambient light artifact (sunlight/artificial light) for oximeter testing under the Simulations menu.
  • Page 74 Index 2MF Users Guide Note Pressing more returns you to Main Menu 1. Pressing esc in any of the following screens returns you to Main Menu 2. 2. Press UTIL to access the Utilities Menus: fgg143.eps The Utilities menu allows you to choose from these options: fgg133.eps Note For information on RS232, CKSM, and PTST functions, refer to...
  • Page 75 Adjusting the LCD Screen LCD Contrast Settings esl136.eps Note The maximum level that the contrast can be set to is 7 (the minimum setting 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.
  • Page 76 Index 2MF Users Guide 10-4...

  • Page 77: Manufacturers Mode

    Chapter 11 Manufacturers Mode Introduction Fluke Biomedical has included several features in the Simulator specifically designed to aid manufacturers of pulse oximeters. Those features ease the following manufacturing- specific needs: The automatic production testing of pulse oximeters The automatic production testing of oximeter probes...

  • Page 78: Mathematical Background

    Index 2MF Users Guide Fluke Biomedical has equipped the Simulator to allow you the widest array of simulation, with the capability for direct control of the following the Simulator functionality: Bulk red light attenuation Bulk infrared light attenuation Peak-to-peak red pleth wave amplitude control...

  • Page 79: Notes On The Formulas

    Manufacturers Mode Mathematical Background The the Simulator calculates the R-value (as far as the oximeter is concerned) with this formula: (0<=ac <=255) (0<=rdc <=4095) REDUUT (0<=rac <=4095) 4095 4095 (0<=rdc <=4095) REDUUT 4095 esl140.eps __________________________________________________________________ (0<=ac <=255) (0<=irdc <=4095) IREDUUT (0<=irac <=4095) 4095 4095...

  • Page 80: Accessing Manufacturers' Tests

    Index 2MF Users Guide This is the equation used to obtain the R-values used in the Simulator, and presented on the LCD screen. Although the equation eliminates the effect of changes in the UUT flash amplitude on the R-value, bulk attenuation of an actual finger is an important characteristic. By varying rdc or irdc values and determining how large a range of variation is “not seen”...

  • Page 81: Setting The R-Value

    Manufacturers Mode Accessing Manufacturers' Tests The Waveform Source screen provides two options: esl146.eps 2. Select the oximeter by pressing UUT (Unit Under Test) as the source for the pulse amplitude signal. esl147.eps 3. Alternatively, press DC. The Simulator will ignore the oximeter's pulse amplitude and will use instead a fixed dc level for infrared and red pulse simulations.

  • Page 82: Adjusting The Step Amount

    Index 2MF Users Guide esl150.eps 3. To raise or lower the R-value one step-amount at a time, use the softkeys +R or -R. In the sample below, the step amount is 0.020, and thus pressing the softkey +R raises the previous R-value from 0.610 to 0.630: esl151.eps 4.

  • Page 83: Creating Your Own R-Curve

    Chapter 12 Creating Your Own R-Curve Introduction The Simulator will store six download R-Curves into download slots according to specific light levels. You may trade a preprogrammed make for one that you use more regularly. This chapter explains how to create an R-Curve and download it to one of the “download slots”...

  • Page 84: Generating An R-Curve From A Pulse Oximeter

    Index 2MF Users Guide Generating an R-Curve from a Pulse Oximeter 1. Set up the Pulse Oximeter and attach it to the Simulator. 2. From MAIN MENU 1 select SIM | MAN, set: SpO2 = 100% = 100 3. From MAIN MENU 2 select OPTS | RVAL, set: Step = 0.010 Note...
  • Page 85 Creating Your Own R-Curve Downloading an R-Curve into the Simulator hort nstructions PN 2227040 Rev. A INDEX R-CURVE DATA SHEET Date: Recorded by: Pulse Oximeter Model: Pulse Oximeter Serial Number: Pulse 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: Appendices

    Appendices Appendix Title Page Printing and Data Transfer .................. A-1 Error Messages and Corrective Measures ............B-1 Accessories List ....................C-1 Specifications ...................... D-1 Computer Control....................E-1 Typical Questions and Answers................F-1 Custom Probe Test Cables and Electrical Simulation Cables ......G-1 Glossary.......................
  • Page 88 Index 2MF Users Guide...

  • Page 89: A Printing And Data Transfer

    Simulator. The Data Computer Equipment (DCE) wiring configuration is shown Figure A-1. Index 2MF RS232 Configuration Fluke Biomedical 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.
  • Page 90 Figure A-2. Index 2MF Parallel Port D-25 A Standard D-25 pin to Centronics printer cable works with the Simulator. Please 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 and parity.
  • Page 91 Appendices Printing and Data Transfer 2400 bps 9600 bps Parity: None Even Stop and data bits: 1 or 2 stop bits 7 or 8 data bits Accessing the Utilities Menu 1. Press UTIL on the the Simulator Main menu 2 (first press more if you are viewing Main Menu 1).
  • Page 92 Index 2MF Users Guide 4. Press R232 to set the RS232 port parameters: esl167.eps 5. Press the softkey under the baud rate, parity type, and data and stop bit sizes to set the correct communications parameters for your printer or other device. Table A-1 describes parameters used for PC to peripheral communication.
  • Page 93 “Technician” field. Actuals are all information under the “Settings:” heading. A normal report includes only the fields Alarm Response Time, Rate Alarm Response Time, and Pulse Amplitude Test. Fluke Biomedical SPO2 Simulator Ver: 2.00 -------------------------------------- Control#: __________________________ Serial #: __________________________...
  • Page 94 Index 2MF Users Guide...

  • Page 95: B Error Messages And Corrective Measures

    Appendix B Error Messages and Corrective Measures Introduction This Appendix lists all of the error messages or beeps that may appear on the Simulator's LCD screen during normal operation. Solutions are given for each message. Messages If the battery has run down, the following message appears: Warning! Low Battery Although the battery included with the Simulator can run continuously for up to 8 hours, it does need regular recharging, especially after long periods of disuse.
  • Page 96 Index 2MF Users Guide Other Error Indications Pulse Oximeter Not Reading SpO2 or Heart Rate The display 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.

  • Page 97: C Accessories List

    Appendix C Accessories List Introduction Table C-1 presents a list of accessories available for the Simulator. The User's Guide and a battery charger (U.S. or European) are standard equipment. Table C-1. Accessories Description Part Number 3341210 Index 2MF User's Guide Carrying Case 2204282 Charger (USA)
  • Page 98 Index 2MF Users Guide...

  • Page 99: Specifications

    Appendix D Specifications Equipment Specifications The following specifications apply to the Index 2MF and 2MFE. Range ..............35 to 100 % Resolution ............1 % Accuracy ............. 100 to 75 %: +1 % accuracy of the pulse oximeter under test. 74 to 50 %: + 3 % the accuracy of the pulse oximeter under test.
  • Page 100 Index 2MF Users Guide Dynamic Test Test Format............Photo detector/diode response to both the red and infrared light generated by the probe when pulsed by an internal test signal. Test Signal ............Pulsed between the two LEDs, constant current level at 1.0 mA Test Results ............

  • Page 101: Computer Control

    Appendix E Computer Control Introduction You can set up a program to communicate with and control the Simulator via its RS232 port. To control the Simulator by computer: 1. Switch the Simulator power on using the slide switch. The LCD sequentially displays the following screens for about one second each before ending on the Main Menu 1 screen: Bio-Tek Instruments Inc.
  • Page 102 Index 2MF Users Guide Note You will need communications software to send data to Index 2MF. Any commercial DOS or Windows communications package — such as Procomm from Datastorm Technologies, Smartcom from Hayes, Bit Software's Bitcom, or Microsoft Windows' “HyperTerminal” program — will do.
  • Page 103 Appendices Computer Control Computer Control Commands Table E-1 shows valid commands for controlling the Simulator by computer. Note The Simulator normally responds to computer control commands by calculating all simulation values for each new simulation commanded. This may take over one second and interrupts the wave generation. Table E-1.
  • Page 104 Index 2MF Users Guide Command Description Values Example MFREQ Sets the artificial light artifact frequency in Hertz. 45.000 to [MFREQ 60.1] nn.nnn Internal resolution at 60 Hz is about 0.2 Hz. To 75.000 let the user know the effects of input rounding, the rounded value is output on the RS-232.
  • Page 105 Appendices Computer Control Table E-1. Valid Commands (cont.) Command Description Values Example SHAPE Indicates that the next 64 numbers represent a [SHAPE1.000, 3.9, pleth wave shape. 4.9,...] SHIVER Causes shiver artifact, a motion wave of [SHIVER] 6.0 Hz. SRCF Selects DC or fixed signal source level. [SCRF] SRCU Selects the test unit's signal source level.
  • Page 106 Index 2MF Users Guide The above data stream must all be on one line. When downloaded, the computer control screen shall show the message from the beginning to the end of the oximeter name. Use the MAKE selection screen and [settings] to verify download.
  • Page 107 "played back" through the Simulator in real time. These are long-duration files (player files) of real physiological behavior. These files are only available from select pulse oximeter manufacturers. Fluke Biomedical does not supply them. Player file data is uploaded through the Simulator’s serial port and loaded directly into the red AC and infrared AC digital-to-analog converters (DACs).
  • Page 108 Index 2MF Users Guide Note In order to use Player Mode, it may be necessary to boot 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"...

  • Page 109: Typical Questions And Answers

    Appendix F Typical Questions and Answers Introduction 1. How do I connect a probe from a pulse oximeter to Index 2MF? With the pulse oximeter turned on, look for the visible red light coming from the probe. This side of the pulse oximeter finger probe must go on the bottom of the Index 2MF finger probe attachment.
  • Page 110 Index 2MF Users Guide Attaching the Probe to Index (Ohmeda FingerClip Probe) Attachment of the FingerClip Probe Misapplied Detector Window Finger Stop Properly Applied esl157.eps Figure F-1. Attaching the Probe to Index 2MF The low readings may be because the Pulse Oximeter under test is a Nellcor unit but the user has Ohmeda selected.
  • Page 111 Ohmeda probes - an in-line adapter forces the monitor to the calibration curve that matches that of Index 2MF. 7. How did Fluke Biomedical obtain the R-curves? We worked with each manufacturer and they sent us a pulse oximeter for characterization.
  • Page 112 Index 2MF Users Guide...

  • Page 113: G Custom Probe Test Cables And Electrical Simulation Cables

    Appendix G Custom Probe Test Cables and Electrical Simulation Cables Introduction This Appendix explains how to make custom probe adapter cables and electrical simulation cables to be used with your Index 2MFE. Making Probe Test Cables Index 2MFE can be used to test probes using custom probe adapter cables. Figure G-1 shows a typical oximeter probe.
  • Page 114 Index 2MF Users Guide LEDs PHOTODIODE OPTIONAL SHIELDING OPTIONAL CALIBRATING RESISTOR 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.
  • Page 115 Simulator 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 interface cable, the following information will enable you to make your own interface cable.
  • Page 116 Index 2MF Users Guide Table G-1. Resistances with LED Arrangements Technology Options Typical Oximeter 10 K Back to back (typical of Nellcor) 20 K Common cathode 30 K Common Anode (typical of Ohmeda) 40 K Completely separate Before testing the probe, the Simulator reads this resistor to determine the LED connection being tested.
  • Page 117 Appendices Custom Probe Test Cables and Electrical Simulation Cables Example: Ohmeda Probe Test Index 2 Ohmeda Probe ID Res Common 30 k 1% esl168.eps Figure G-3. Example: Ohmeda Probe Test...
  • Page 118 To avoid damage to the oximeter and the Simulator, take into account all of the relevant details of the oximeter’s probe operating scheme. Under no circumstances shall Fluke Biomedical be responsible for any damages. Figure G-4 is the hardwire test interface from the Index 2MF.
  • Page 119 Appendices Custom Probe Test Cables and Electrical Simulation Cables GENERIC OXIMETER PINS BY USAGE INDEX 2 NELLCOR OHMEDA CONNECTION FOR FLOATING SILICON DIODE: TRUE DIFFERENTIAL SOURCE SINGLE-ENDED POSITIVE OR NEGATIVE CURRENT OR VOLTAGE PHOTO DIODE SIMULATION SOURCES GROUND POSITIVE VOTAGE PULSES NEGATIVE VOLTAGE PULSES C,D: VOLTAGE TO CURRENT SOURCE CONVERSION...
  • Page 120 Index 2MF Users Guide In some cases, it may be advantageous to not use the floating diode source. In these cases, the Simulator provides a ground pin at pin 9, and both positive and negative simulation voltage signals on pins 7 and 8. These may be converted to current signals by appropriate scaling resistors as noted in Figure G-5.

  • Page 121: H Glossary

    Introduction The glossary presents certain medical, electronic and the Simulator-specific terms, the ® understanding of which may aid in the operation of the Fluke Biomedical Index2 SpO 2 Simulator. Definitions that appear in this glossary are from Merriam-Webster Online Dictionary, 2005 and Newton’s Telecom Dictionary, 18...
  • Page 122 Index 2MF Users Guide Asynchronous transmission allows a character to be sent at random after the preceding character has been sent, without regard to any timing device. baud A transmission speed measurement across a medium. Baud (after J.M.E. Baudot, 1845- 1903) denotes the number of discrete signal elements, such as bits, transmitted per second.
  • Page 123 Appendices Glossary heme The non-protein, ferrous-iron-containing component of hemoglobin. hemoglobin The oxygen-bearing, iron-containing conjugated protein in vertebrate red blood cells, consisting of about 6 per cent heme and 94 per cent globin. Hertz (Hz) A unit of frequency equal to one cycle per second. Used to measure electrical current and light, especially ultraviolet radiation (as in fluorescent light).
  • Page 124 Index 2MF Users Guide non-invasive A medical procedure neither invasive nor involving an invasive action, not tending to spread, especially not tending to invade healthy tissue. ohms A unit of electrical equal to that of a conductor in which a current of one resistance is produced by a potential of one across its terminals.
  • Page 125 Appendices Glossary SpO 2 The type of saturated oxygen measured with a pulse oximeter. tachycardia condition characterized by an excessively rapid heartbeat. cardiovascular venous 1. Of or pertaining to a vein or veins. 2. Returning to the heart through the great veins. ventricle A small anatomical cavity or chamber in the heart, although also the brain.
  • Page 126 Index 2MF Users Guide...

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