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Rigel 344 Operating Manual

Defibrillator tester / pacer analyser / ecg simulator
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RIGEL 344
Defibrillator Tester / Pacer Analyser / ECG Simulator
Operating Manual
Bracken Hill
South West Industrial Estate
Peterlee, County Durham
SR8 2SW, England
Phone: +44 (0) 191 586 3511 Fax: +44 (0) 191 5860227
www.rigelmedical.com
RIGEL 344 User Manual Rev 2.0

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  • Page 1 Defibrillator Tester / Pacer Analyser / ECG Simulator Operating Manual Bracken Hill South West Industrial Estate Peterlee, County Durham SR8 2SW, England Phone: +44 (0) 191 586 3511 Fax: +44 (0) 191 5860227 www.rigelmedical.com RIGEL 344 User Manual Rev 2.0...
  • Page 2 Rigel Medical, or if its serial number is defaced or removed. Rigel Medical reserves the right to discontinue the RIGEL 344 at any time, and change its specifications, price, or design without notice and without incurring any obligation.
  • Page 3 RIGEL 344 User Manual...

  • Page 4: Table Of Contents

    2.9.6 Demand Sensitivity Tests ------------------------ 2.9.7 Immunity Tests ----------------------------------- 2.9.8 Measuring Energy -------------------------------- 2.10 Testing External Transvenous Pacers (AV) ---------- 29 2.10.1 Measuring Pulse Parameters ------------------- 29 2.10.2 Measuring Refractory Periods ---------------- 29 2.10.3 Demand Sensitivity Tests ---------------------- 30 RIGEL 344 User Manual...
  • Page 5 2.14.4 Printer Format Selection ---------------------- 38 2.14.5 Pacemaker Battery Current Test ------------- 39 3. Palm Pilot Interface 3.1 Introduction ------------------------------------------ 39 3.2 Rigel PalmSoft Set Up Procedure -------------- 3.3 Receiving and Saving Data ----------------------- 40 4. Theory of Operation 4.1 Introduction ---------------------------------------- 4.2 Defibrillator Output Measurement...
  • Page 6 This Manual is provided to explain the operation of the RIGEL 344 Defibrillator Tester / Pacemaker Analyser / ECG Simulator test instrument. It is intended for the biomedical engineering or clinical engineering technician involved in the testing of defibrillators and external pacemakers.

  • Page 7: General Overview

    ECG arrhythmia simulator into one compact instrument. The Rigel 344 is designed to accurately measure the output parameters of defibrillators and external pacemakers, including both transthoracic and transcutaneous devices. It simulates a wide variety of arrhythmia waveforms for testing automatic defibrillators and ECG equipment.

  • Page 8: Safety Considerations

    Measures the current drain (ON / OFF) of the pacemaker, using the optional adapter (PN xxxxx). 1.1.3 ECG / Arrhythmia Simulator Functions The Rigel 344 simulates a normal sinus rhythm ECG waveform along with several arrhythmias. It also generates sine, square, triangle, and pulse performance waveforms.
  • Page 9 RIGEL 344 User Manual...

  • Page 10: Specifications

    1.3.2.2 Transvenous (Atrial and Ventricular) Test Load: 500 Ohms ± 1%. Current: 1 to 25 mA. Accuracy: ± 5% +. 5 mA. Pulse Rate: 30 to 800 ppm. Pulse Width: 0.5 to 80 ms. Accuracy: ± 1% +.1 ms. RIGEL 344 User Manual...
  • Page 11 1.3.4 RS 232 Output A computer interface is available to print test results or to save them on a PC. The test results can be saved directly to a Palm Pilot using Rigel Medical’s optional palm software. 1.3.5 Power Requirements Two 9- Volt Alkaline Batteries or AC adapter.

  • Page 12: Accessories

    651-Zoll PhysioControl 651-Physio Marquette 651-MARQ Laerdhal 651-LAED Universal A/V Pacer Adapter Cable Pacemaker Battery Test Adapter Cable 652-BATT Transcutaneous Pacer Adapters: Zoll Call for Part Number Call for Part Number Physio Control Call for Part Number RIGEL 344 User Manual...

  • Page 13: Operating Instructions

    If no damage is found to the shipping box, open the box and perform a visual inspection of the Rigel 344. If any damage to the unit is observed please contact Rigel Medical Customer Service. The Rigel Medical warranty statement is listed in the warranty section of this manual.

  • Page 14: Instrument Familiarity

    2.2 Instrument Familiarity Before proceeding to use the RIGEL 344 make sure you read this manual and become familiar with the functions all of the controls and the menu operation. RIGEL 344 1. Defib. Paddle Contacts: Function Keys Apex (R) Sternum (L) Power Switch 2.

  • Page 15: Power Up And Initialisation

    5 seconds. 2.3.1 RS 232 Setup The Rigel 344 can be connected to a printer or a PC via the RS 232C SERIAL PORT located on the side of the instrument. The default settings for the serial communication are: Baud Rate = 9600, Data Bits = 8, Parity = None, Stop Bit = 1 These settings must be the same for the PC or the Printer.
  • Page 16 ‘F4’ Key Pressed = Simulator Menu m u l A M P : 1 m V E C G : 0 b p m E C G A R R T H P E R F A M P L RIGEL 344 User Manual...

  • Page 17: Testing A Defibrillator

    B. Turn the RIGEL 344 on and move the function selector switch to the DEFIB mode. The Defibrillator Main Menu, Figure 1, will be displayed. C. The RIGEL 344 is in the energy measurement mode and is ready to make an energy measurement. RIGEL 344 User Manual...

  • Page 18: Peak Voltage And Current

    2.5.3 Viewing Waveform Output 2.5.3.1 On a Defibrillator Monitor 1. After the defibrillator is discharged, and while the RIGEL 344 is in the energy mode, the captured waveform will be available through the ECG leads, the paddle contacts, and the high level output jack on the side panel.
  • Page 19 RIGEL 344 User Manual...

  • Page 20: Measuring Cardioversion (Sync.) Time

    B. A simulated ECG waveform @ 60BPM is output through the ECG leads and paddles. C. Select the source of the ECG waveform on your defibrillator. Observe the ECG coming out of the RIGEL 344 on your defibrillator monitor. D. Set the defibrillator to the synchronize mode.

  • Page 21: Selecting Waveforms

    A. Connect the paddle adapters to the circular contact plates (for fully automatic defibrillators) or place the paddles firmly on the paddle contacts (for semi automatic defibrillators with paddles) and discharge the defibrillator. B. The RIGEL 344 will display the measured energy. RIGEL 344 User Manual...

  • Page 22: Printing Defibrillator Measurement Data

    2.7 Printing Defibrillator Measurement Data A. Press the ‘PRN’ key on the Keypad to print the measured test data from the RIGEL 344 in the defibrillator mode. B. The first time the ‘PRN’ key is pressed, the header shown below...

  • Page 23: Ecg Arrhythmia Simulator

    Peak Voltage: 1739 Volts Peak Current: 34 Amp 2.8 ECG ARRHYTHMIA SIMULATOR The RIGEL 344 is a 12 lead ECG arrhythmia simulator. In addition to simulating a normal sinus rhythm and 12 arrhythmia waveforms, the instrument will generate four different performance waveforms.

  • Page 24: Generating Normal Sinus Rhythm Waveform

    The default arrhythmia is VFB course and the amplitude is set at 1 millivolt. B. The ‘←’ and ‘→’ keys to advance through the arrhythmia selection menu. C. Press the appropriate key to select an arrhythmia waveform. RIGEL 344 User Manual...

  • Page 25: Arrhythmia Waveform Definitions

    The selected amplitude will remain in effect as long as you are in the simulator menu. Note: When the RIGEL 344 is switched to the energy mode from the simulator menu, the waveform amplitude will return to the default value of 1 mV.

  • Page 26: Testing Transthoracic Pacers

    The RIGEL 344 provides a choice of utilizing either a fixed 50 Ohm test load or a built-in variable test load for testing transthoracic pacemakers. Before performing any tests connect the pacemaker to...

  • Page 27: Selecting 50 Ohm Test Load

    LifePak models or the ‘Others’ key to select all other manufacturers. 2.9.2 Selecting 50 Ohm Fixed Test Load A. Move the Mode switch on the RIGEL 344 to PACER. B. Move the pacer input selector switch on the side panel to the TRANS. INPUT position.

  • Page 28: Selecting Variable Test Loads

    2.9.3 Selecting Variable Test Loads A. Move the Mode switch on the RIGEL 344 to PACER. B. Move the pacer input selector switch on the side panel to the TRANS. INPUT position. C. Connect the transcutaneous pacer to the VAR. LOAD input connectors.

  • Page 29: Demand Sensitivity Tests

    B. Press the ‘Sens’ F1 key for the demand sensitivity measurement. Sensitivity Menu: ‘Sens’ F1 Key Pressed S E n T B Y C. Press the F1 key to select a square (Sqr), triangle (Tri), or (SSQ) waveform. RIGEL 344 User Manual...

  • Page 30: Immunity Tests

    C. Press the ‘Imm’ F2 key for the noise immunity test. Immunity Menu: ‘Imm’ F2 Key Pressed m m u D. Press the ‘60Hz’ F1 key for a sine wave of 60Hz E. Press the ‘50Hz’ F4 key for a sine wave of 50Hz. RIGEL 344 User Manual...

  • Page 31: Measuring Energy

    E. Press the ‘ESC’ key to return to the previous (Level 2) menu. 2.10 Testing External Transvenous Pacers (AV) The RIGEL 344 will test both atrial and ventricular transvenous pacemakers. Before performing any tests connect the pacemaker to be tested to either the ATR (Atrial) or VENT ( Ventricular) A-V INPUT connectors on the side panel.

  • Page 32: Measuring Refractory Periods

    A. Select Level 1 in Pacer Test Main Menu. B. Press the ‘Ref’ L4 key for the refractory period measurement. C. Press the ‘Pace’ F1 key for paced refractory period measurement. D. Press the ‘Sense’ F4 key for sensed refractory period measurement. RIGEL 344 User Manual...

  • Page 33: Demand Sensitivity Tests

    E. ‘STBY’ will flash on the top line until a measurement is made. During the sensitivity measurement, the pacemaker pulse rate selection depends on the waveform and the width selected. For certain widths and pacer rates, the waveform may fall within the RIGEL 344 User Manual...

  • Page 34: Immunity Tests

    The default setting is 54.3 mV. Each time the ‘à’ key is pressed the amplitude increases by 6.8 mV. Each time the ‘ß’ key is pressed the amplitude decreases by 6.8 mV. 2.10.5 Measuring AV Interval RIGEL 344 User Manual...
  • Page 35 A. Press the ‘ESC’ key to return to the Level 2 Main Pacer Test Menu. B. Press the ‘AV-D’ F3 key from the main menu for A-V Delay measurements. RIGEL 344 User Manual...

  • Page 36: Measuring Energy

    Note: The select switch must be in the A-V position and inputs must be connected to both the ATR and VENT input jacks on the RIGEL 344. The amplitude values for both atrial and ventricular output on the pacemaker must be set to 0.1mA or higher.
  • Page 37 RIGEL 344 User Manual...

  • Page 38: Printing Without A Header

    A. Press the ‘PRN’ key on the Keypad to print the measured test data from the RIGEL 344 in the Pacer Test mode. B. The RIGEL 344 will send data to the printer port each time the display updates with current parameter measurements.

  • Page 39: Printer Functions

    User modified values, may be saved for use in subsequent tests as long as the RIGEL 344 is not turned off. The user can leave the modified value unsaved so that the original default values will be output during subsequent tests.

  • Page 40: Auxiliary Functions

    (online LED lights up). Now the printer is ready to receive data from the RIGEL 344. Select ‘PRI’ in the main menu of the RIGEL 344 and press the F1 key. The ‘Select Printer’ menu is now displayed showing the printer options.

  • Page 41: Av Pacer Test Function

    A u x T s t 2.14.1 AV Pacer Test Function In the AV Pacer Test Mode, the RIGEL 344 inputs a DC output voltage of 100 millivolts ± 5 and displays both the input and the measured values. A. Select the AV Pacer Mode.
  • Page 42 C. Place the Pacer Select Switch in the TRANS Input position. D. Disconnect the input to the RIGEL 344. E. Connect the voltmeter to the Vent jacks of the A-V Intput connectors. F. Press the ‘ESC’ key. G. Read the measurement in mv on the voltmeter display.

  • Page 43: Transcutaneous Pacer Test Function

    Rigel 344 should be recalibrated. 2.14.3 Calibration Check The RIGEL 344 can be configured as a DC voltmeter and used to check the amplitude calibration. A. Press the ‘CA’ F2 key to perform the amplitude calibration check.

  • Page 44: Pacemaker Battery Current Test

    Left margin set Print 16 characters 2.14.5 Pacemaker Battery Current Test The RIGEL 344 will measure the battery current of the pacemaker to be tested. The Rigel Medical 652-Battery Adapter is required to perform this measurement. A. Connect the battery adapter to the pacemaker and a 9 Volt battery.

  • Page 45: Palm Pilot Interface

    3.2 Rigel Medical PalmSoft Set Up Procedure A. Load the Rigel Medical PalmSoft software into the Palm Pilot. Connect the Palm Pilot to the RIGEL 344 using the Rigel Medical serial interface cable, 650-Palm-Cable. Activate the Rigel Medical PalmSoft software.
  • Page 46 Peak Current: 34 Amp D. Set the test values for the instrument to be tested, see Fig B above. E. Save the file. F. The file is now available for printing or transferring to a PC. RIGEL 344 User Manual...

  • Page 47: Theory Of Operation

    ‘R’ and ‘t’ is the duration of the waveform in seconds. The Rigel 344 measures the instantaneous voltage (attenuated by a factor of 2000/1.1), every 105 microseconds for a duration of 65 milliseconds. The Microcontroller computes the energy by summing up the squared voltages multiplied by the time and divides the product by 50 (load resistance).

  • Page 48: Circuit Block Descriptions

    Micro Controller PROM (32K) RAM (32K) Diff. Output Function Amp. Selector Defib Input Differential Load Input Amp. Power Supplies 9 Volt 9 Volt +5, +5AV, -5AV Battery Adapter 2.5000 Vref. Block Diagram 4.4.1 Defibrillator Input Load RIGEL 344 User Manual...
  • Page 49 The input load consists of two 25 Ohm 95 Watt 1% wire wound resistors that simulate the impedance of the human thorax under high voltage conditions. RIGEL 344 User Manual...
  • Page 50 4.4.5 Power Supplies The Rigel 344 is powered by two 9 Volt Alkaline batteries. The volt is converted into +5V, +5AV by low dropout linear regulators. The –5AV is generated by a charge pump regulator. The +5AV and –5AV is used to power the op amps and +5V is used for the digital circuits.
  • Page 51 When a key is pressed the micro controller responds by changing the appropriate menu on the display. RIGEL 344 User Manual...
  • Page 52 The memory consists of 32 K internal ROM, 32 K external ROM, and 32 K RAM. The internal and external PROM contains the software necessary to control the Rigel 344. The static RAM is used during program execution to hold buffers and stack operation.
  • Page 53 TROUBLESHOOTING Section 5 5.1 Troubleshooting Chart The following chart is provided for basic troubleshooting. Problems other than those listed should be addressed to the Rigel Medical Technical Service Department at +44 (0) 191 5878716. Description Cause Action On Power up the...

  • Page 54: Appendix

    Appendix A Section RIGEL 344 User Manual...

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