Rigel 333 Manual
Contents
1. 80 1 100 206 1 0 80 1 100 206 0 5 80 1 100 206 2 0 26 80 1 100 195 2 0 80 1 100 195 1 0 80 1 100 195 4 0 RESPIRATION Select Resp in the Simulator Menu to access the Respiration selections Resp Menu Rate Imp dR Apne Respiration waveforms are generated with four selectable rates baseline impedances and delta impedance variations The Respiration default settings are Respiration Rate 30 BPM Impedance 500 Ohms Delta Impedance 1 0 Ohm Apnea Off The value changes that may be made are Rate 15 30 60 120 BPM Impedance 250 500 750 and 1000 Ohms Delta Impedance 0 1 0 5 1 0 and 1 5 Ohms Apnea Resp Apne Off Off Cont 12s 32s PAT Off Apnea is absent Normal respiration waveforms are generated Cont Continuous Apnea No respiration waveforms are generated 12s No respiration waveform is generated for 12 seconds 32s No respiration waveform is generated for 32 seconds BLOOD PRESSURE Select Bp in the Simulator Menu to access Blood Pressure selections BP1 Menu Dyna Stat Two blood pressure waveforms are generated with selections of 12 static and 6 dynamic values BP1 values are selected from the listed choices and BP2 values are 1 2 of those selected for BP 1 The Dynamic pressure waveforms track the Normal Sinus Rhythm rates The default settings for pressure values are BP1 Dynamic 120 80 Static 0 BP2 Dynamic 60 40 Static 0 The Dynamic pressure value selections are2. 100 60 120 80 28 50 10 60 20 70 30 80 40 The Static pressure value selections are O 5 10 20 25 30 40 50 100 150 200 300 TEMPERATURE Select Temp in the Simulator Menu to access Temperature value selections Temp Menu YSI400 YSI700 Temperature simulation is provided for both YSI 400 and YSI 700 standards The temperature default setting for both is 25 degrees Centigrade The Temperature value selections are 25C 37C for both YSI 400 and YSI 700 CALIBRATION The Rigel 333 is shipped from the factory fully calibrated with a Certificate of Calibration traceable to the NIST Annual calibration is recommended Contact the Customer Service Department for 29 instructions for returning the instrument to Rigel Medical for either calibration or repair SPECIFICATIONS ECG 12 leads with independent outputs referenced to RL NORMAL SINUS RHYTHM NSR ECG Rates 30 60 70 80 90 100 120 150 180 210 240 270 300 and 350 BPM Accuracy 0 5 Amplitudes 0 15 0 3 0 5 1 0 2 0 3 0 4 0 and 5 0 mV on Lead II Lead 1 is 0 6 X Lead II Lead Ill is 0 4 X Lead Il and Lead V is the same as Lead Il High Level 500 X low level output on Lead Il Accuracy 2 1 5mV PERFORMANCE WAVEFORMS PERF Sine Square Triangle Pulse Frequencies 0 1 to 0 9 in 0 1 Hz steps 1 0 to 9 0 in 1 0 Hz steps 10 to 100 in 10 Hz steps Accuracy 1 Amplitudes 0 1 0 2 0 5 1 0 2 0 3 0 4 0 and 5 0 mV on Lead Il
3. intervals are generated The rate varies in a cyclic fashion at 30 60 70 80 and 30 BPM with low amplitude oscillations on the baseline PAT Paroxysmal Atrial Tachycardia NSR is generated at 180 BPM with inverted P waves NODL Junctional Premature Contraction NSR is generated at 80 BPM with a short PR interval The QRS starts immediately following the P wave AC Atrial Conduction Arrhythmias AB1 First Degree AV Block The QRS is generated at 80 BPM the P wave precedes the QRS by a fixed but prolonged PR interval gt 0 2 seconds PR interval 0 26 seconds MB1 Second Degree AV Block Mobitz I Wenckebach The QRS is generated at 80 BPM There is a progressive lengthening of the PR interval with intermittent dropped beats The PR intervals are 170 230 and 310 ms 18 MB2 Second Degree AV Block Mobitz Il The QRS is generated at 80 BPM with every 4 QRS missing The PR interval is constant at 170 ms AB3 Third degree AV Block The P wave and QRS are independent of each other The P wave is generated at 80 BPM and the QRS is generated at 50 BPM RBB Right Bundle Branch Block A prolonged QRS gt 0 12 sec is generated at 80 BPM The resulting QRS looks like the letter M LBB Left Bundle Branch Block A widened QRS is generated at 80 BPM with a large wide S wave LAH Left Anterior Hemiblock A QRS is generated at 80 BPM with an S wave larger than the R wave Ventricular Ventricular Arrhythmias
4. 2 0 5 1 0 1 5 2 0 Ampl amplitude selections 15 0 3 0 5 1 0 2 0 3 0 4 0 5 0 ASP Asynchronous Pacer Ineffective pacing 11 A non synchronized waveform that combines QRS waves at 30 BPM and other specifications as in AP above with pacer waves with a 0 1 ms or 2 ms width and amplitude of 2 mV at 80 BPM Note 0 1 ms pacer width for AP and ASP can only be selected by going to PCR A selection other than 0 1 ms produces 2 ms wide pulses Selecting Vent branches to Vtr_Pcr Waves VP AVP VP Ventricular Pacer at 70 BPM AVP Atrial Ventricular Pacer at 70 BPM Selecting ST branches to ST SEGMENT ele dep MI TalT ST segment analysis waveforms are divided into four classes ele ST Elevation dep ST Depression MI Myocardial Infarction TalT Tall T Wave Rejection ST _ELVATION 1 13 20 Flat ST Elevation 7 13 and 20 DC levels of ST Elevation may be selected Example at a QRS amplitude of 1 mV ST segments are produced at positive DC levels of 70 130 and 200 micro volts Waveforms may be selected with a Flat a positive sl or a negative ssl slope The ST segment is proportional to the ECG amplitude setting ST _DPRESION 7 13 20 Flat ST Depression Identical to ST Elevation except the ST segments are now depressed Selecting MI Myocardial Infarction branches to Myocard Inf Isc Inj Inf linf Isc Ischemia Inj Injury Inf Infarction linf Inferior Infarction
5. 30 Pulse 20 ms pulse of 1mV amplitude repeated at 4 second intervals R WAVE DETECTION RWD Widths 10 40 50 60 70 80 90 100 110 and 120 ms Amplitudes 0 15 0 3 0 5 1 0 2 0 3 0 4 0 5 0 mV on Lead Il PACER PCR AP Atrial Pacer set at 70 BPM ASP Asynchronous Pacer Ineffective Pacing Pacer Amplitudes 2 mV and 2mV QRS Amplitudes 1 mV PCR Pacer pulses alone Pacer Widths 0 1 0 2 0 5 1 0 1 5 and 2 0 ms Amplitudes 0 15 0 3 0 5 1 0 2 0 3 0 4 0 and 5 0 mV VP Ventricular Pacer set at 70 BPM AVP Atrial Ventricular Pacer set at 70 BPM QRS Amplitude 1 mV Pacer Amplitude 2mV RESPIRATION Baseline Impedance 250 500 750 and 1000 Ohms Delta Impedance 0 1 0 5 1 0 and 1 5 Ohms Accuracy 10 Rates 15 30 60 and 120 BPM 31 Accuracy 1 Apnea Off continuous 12 seconds and 32 seconds Lead Configuration Leads and Il BLOOD PRESSURE Impedance 350 Ohms Excitation 2 to 16 Volts Sensitivity 5uV V mmHg Static 0 5 10 20 25 30 40 50 100 150 200 and 300 mmHg Dynamic 50 10 60 20 70 30 80 40 100 60 and 120 80 mmHg Dynamic waveforms track all NSR rates TEMPERATURE Compatibility YSI 400 and 700 Series Temperature 25 and 37 degrees Centigrade Accuracy 2 of setting POWER REQUIRMENTS One 9 Volt alkaline battery or optional AC adapter PHYSICAL CHARACTERISTICS Dimensions 13 9 X 8 9 X 3 8 cm Weight 0 3 kg
6. PV1 Premature Ventricular Contraction 1 NSR is generated at 80 BPM Each time the F1 function key is pressed one PVC is generated 19 PV3 Premature Ventricular Contraction 3 NSR is generated at 80 BPM Each time the F2 function key is pressed 3 PVCs are generated PV6 Premature Ventricular Contraction 6 NSR is generated at 80 BPM Each time the F3 function key is pressed 6 PVCs are generated PV12 Premature Ventricular Contraction 12 NSR is generated at 80 BPM Each time the F4 function key is pressed 12 PVCs are generated at different intervals PV24 Premature Ventricular Contraction 24 NSR is generated at 80 BPM Each time the F1 function key is pressed 24 PVCs are generated at different intervals BGY Bigeminy NSR is generated at 80 BPM with every other beat as a PVC TGY Trigeminy NSR is generated at 80 BPM with every third beat as a PVC PVC Premature Ventricular Contraction Continuous PVCs are generated at 80 BPM VELT Ventricular Flutter Sine waves at 240 BPM are generated with irregular amplitudes 20 VFB Ventricular Fibrillation A totally irregular waveform is generated with chaotic undulations of the baseline VTC Ventricular Tachycardia A fast moving series of PVCs is generated at 210 BPM PVR Right Focal PVC NSR is generated at 80 BPM with every 10 beat a right focal PVC Selecting Aut branches to lt Auto Sequence gt RWD TalT PPR TAC
7. TEMPERATURE REQUIREMENTS Operating 15 to 35 C Storage 0 to 55 C 32 CALIBRATED DC OUTPUTS 10 Calibrated DC outputs from 0 04 to 2 mV OUTPUT CONNECTIONS Part 303 Open Ended Pressure cable Pressure Single Pressure Pin 1 Excitation Pin 4 Signal Pin 2 Signal Pin 5 Excitation Pressure Dual Pressure Pin 3 Signal Pin 2 Signal Part 304 Open Ended temperature Cable 3 5 mm Stereo Jack YSI 400 Tip Ring Shield YSI 700 Tip Ring High Level Output 3 5 mm Stereo Jack Signal Positive Tip Signal Ground Shield Input Unused Ring 33 Note Specifications are subject to change without notice ACCESSORIES Part Number Description User Manual OPTIONAL ACCESSORIES Description Soft Carrying Case 110 VAC Adapter 220 VAC Adapter ECG Snap Studs Open Ended Temperature Cable Pressure Cables Open Ended Space Labs Dual Space Labs Single Datascope Dual Datascope Single Hewlett Packard Dual Hewlett Packard Single Fukuda Denshi Dual Bard Dual Bard Single Mennen Medical Single Ivy Biomedical Single 34 Part Number 301 302 302 220 1000 304 303 305 305 S 306 310 307 308 309 311 311 S 312 314 APPENDIX 35 E RIGEL MEDICAL Designing and Manufacturing Innovative Biomedical and Industrial Test Instruments in the United Kingdom Since 1982 e Electrical Safety Analysers e Pacemaker Analysers e SPO2 Analysers e NIBP Simulators e Defibr
8. and triangle performance waveforms Freq Frequency default setting 1 0 Hz 0 9 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 10 20 30 40 50 60 70 80 90 100 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 Ampl Amplitude default setting 2 0 mV 2 0 3 0 4 0 5 0 0 1 0 2 0 5 1 0 Pulse wave default setting A pulse wave is generated at 4 second intervals with an amplitude of 1mV and width of 20 ms 16 Selecting Arr branches to Arrhythmia Menu Atr AC Vent Arrhythmias are divided into Atrial Atrial Conduction and Ventricular waveforms Normal Sinus Rhythm NSR at 80 BPM is the default waveform in this menu Function keys select the desired arrhythmia and the MENU key clears the arrhythmia to NSR The following are the arrhythmia definitions Atrial Atrial Arrhythmias SA Sinus Arrhythmia The ECG rate uniformly increases and decreases continuously The pattern is cyclic with rates changing in the following order 60 70 80 90 100 90 80 70 60 BPM M80 Missing Beat Normal Sinus Rhythm is generated at 80 BPM with every 10 beat missing AFLT Atrial Flutter Varying ECG rates with 12 cycles at 60 BPM for 12 seconds 9 cycles at 90 BPM for 6 seconds 15 cycles at 150 BPM for 6 17 seconds repeating with large P waves at 300 BPM This corresponds to ventricular responses of 5 1 for 12 seconds 3 1 for 6 seconds and 2 1 for 6 seconds AFB Atrial Fibrillation Irregular QRS complexes with no P waves and constantly changing R R
9. Duration 180 ms Q T Interval 350 ms R R Interval 1 Sec Pacer Amplitude 2 mV 2 mV Width 2 ms 0 1 ms For ineffective pacing ASP the values of the QRS and pacer waves are the same as normal pacing except for the QRS rate that becomes 30 BPM and the pacer rate that becomes 80 BPM During the ASP and AP test sequences the display will show the pacer amplitude the pacer width and the QRS rate For pacemaker pulses alone PCR the values generated are Pacer Rate 60 BPM Width 2 0 ms 0 1 ms Amplitude 2 mV 2 mV 25 During the PCR test sequence the display will show the pacer amplitude the pacer width and the QRS rate Each set of values in the test sequence is generated and displayed for 20 seconds TAC Time to Alarm for Tachycardia The TAC test is designed to measure the time it takes for the patient monitor to alarm after the onset of ventricular tachycardia The low and high alarms on the patient monitor should be set at 60 BPM 100 BPM before starting the test This auto test sequence generates a QRS wave form at the rate of 80 BPM alternating with a ventricular tachycardia waveform with rates of 206 and 195 BPM and amplitudes of 1 0 0 5 2 0 and 4 0 mV Each waveform is generated for 20 seconds and the display will show the amplitude and the rate of the waveform being generated The following is the sequence of waveforms QRS Ventricular Tachycardia Rate Amp Width Rate Amp BPM mV ms BPM mV
10. INSTRUCTION MANUAL Rigel 333 Multi Parameter Patient Simulator Version 2 0 Rigel Medical Seaward Group 18 Bracken Hill Peterlee County Durham e SR8 2SW England www rigelmedical com Dear User We appreciate your purchase of the Rigel 333 Multi Parameter Patient Simulator Properly used the instrument will deliver years of high performance and accuracy This instruction manual has been designed as a tool to assist you in getting the most from your Rigel 333 In order to properly use and to maintain this instrument please read the manual carefully Rigel Medical part of the Seaward Group is recognised as an innovative designer and manufacturer of advanced biomedical and industrial test instruments Seaward Electronic Ltd is ISO 9001 2000 Registered and fully committed to a continuous improvement process Further we guarantee absolute satisfaction with our products Your business is important to us and we are dedicated to providing you with the best customer and technical service possible Please contact us should you have any questions or concerns regarding your instrument We hope you will consider us again when you have a requirement for accurate reliable affordable test instruments Sincerely RIGEL MEDICAL Copyright Copyright 2003 by Rigel Medical All rights reserved No part of this publication may be reproduced or transmitted in any form other than for the purchaser s personal use without wr
11. Isc Ischemia Normal Sinus Rhythm NSR with fully inverted T waves This is a condition of 13 reduced blood supply to the heart in a normal patient INJ Injury A waveform with ST elevation of 20 with a negative slope and inverted T wave Inf Infarction Normal Sinus Rhythm NSR with a large Q wave with the amplitude increased six times and the width increased three times compared to normal linf Inferior Infarction A waveform with the Q wave modified as in Infarction and the ST segment elevated 7 as in ST Elevation Selecting TalT branches to TalT Rate 80 Rate Ampl An 80 BPM QRS test signal of 1 mV amplitude and 100 ms duration is generated with a T wave duration of 180 ms and Q T interval of 350 ms The T wave amplitude may be varied from 0 to 1 2 mV in steps of 0 1 mV Rate 80BPM Amplitude 0 0 0 1 0 2 0 3 0 4 0 5 0 6 0 7 14 0 8 0 9 1 0 1 1 1 2 Selecting RWD branches to RWD Widt Ampl RWD R Wave Detection A QRS waveform is generated at 70 BPM with selectable width and amplitude changes Widt Width default setting 100 msec 70 80 90 100 110 120 10 40 50 60 Ampl Amplitude default setting 1 0 mV 15 0 3 0 5 1 0 2 0 3 0 4 0 5 0 Perf Waves SIN SOR TRI PLS SIN Sine Wave SOR Square Wave TRI Triangle Wave PLS Pulse Wave SIN Freq Ampl 15 SQR Freq Ampl TRI Freq Ampl The frequency and amplitude default settings and choices are the same for the sine square
12. Parameters Amplitude 0 15 mV Width 70 120 ms Rate 30 210 BPM Set 2 Complete Test Sequence Amplitude Width Rate Time mV ms BPM sec 0 15 70 30 210 20 0 15 120 30 210 20 The monitor will not respond to the waveforms in this sequence Set Set 3 Variable Parameters Amplitude 1 0 mV Width 10 ms Rate 30 210 BPM Set 3 Complete Test Sequence 23 Amplitude Width Rate Time mV ms BPM sec 1 0 10 30 210 20 The patient monitor will not respond to the waveforms in the Set 3 test sequence TalT Tall T Wave Rejection QRS and T waves are generated with the following values QRS Rate 80 BPM Amplitude 1 mV Width 100 ms T Wave Duration 180 ms QT Interval 350 ms T Wave Amplitude 0 0 0 2 0 4 0 6 0 8 1 0 and 1 2 mV In the automatic test sequence the T Wave Amplitude steps through the changes at one minute intervals The display indicates the T Wave Amplitude and the QRS Rate As the T wave amplitude increases the first value at which the patient monitor counts the T wave at 80 8 BPM should be noted This value should match the patient monitor manufacturer s specification PPR Pacemaker Pulse Rejection The test sequence cycles through normal paced rhythm 24 AP ineffective pacing Asynchronous Pacing ASP and pacemaker pulses alone PCR For normal pacing AP QRS and pacer waves are generated with the following values QRS Amplitude 1 mV Width 100 ms T wave Amplitude 0 2 mV
13. The Automatic Test Sequence generates test waveforms in sequences according to AAMI requirements eliminating the need for the user to make numerous manual selections The automatic test sequences are RWD R Wave Detection TalT Tall T Wave Rejection PPR Pacemaker Pulse Rejection TAC Time for Alarm for Tachycardia The automatic sequence is initiated when the test is selected and continues until all of the test patterns 21 have been generated During the test sequence the values generated are displayed on the LCD At the completion of the automatic test the display will return to its steady mode RWD R Wave Detection R waves are generated with three varying parameters of amplitude width and rate The three parameter values are displayed on the LCD while generated Each test waveform is displayed for 20 seconds The complete waveform test sequence is performed in three separate sets Set 1 Variable Parameters Amplitude 0 5 2 5 mV Width 100 70 120 ms Rate 80 30 210 BPM Set 1 Complete Test Sequence Amplitude Width Rate Time mV ms BPM sec 0 5 100 80 30 210 20 70 80 30 210 20 120 80 30 210 20 2 0 100 80 30 210 20 70 80 30 210 20 120 80 30 210 20 22 5 0 100 80 30 210 20 70 80 30 210 20 120 80 30 210 20 As the test progresses the indicated heart rate displayed on the patient monitor should be within 10 or 5 BPM whichever is greater of the applied rate Set 2 Variable
14. ees agents or customers In no event shall Rigel Medical or Seaward Electronic be liable for consequential damages Trademarks Rigel Medical and Rigel 333 are trademarks of Seaward Electronic Ltd Any other trademark names used in this manual are only for editorial purposes and the benefit of the respective trademark owner with no intention of improperly using that trademark TABLE OF CONTENTS General Description Controls and Indicators Operating Instructions Baseline ECG Waveform Performance Waveforms Arrhythmia Waveforms Automatic Testing Sequences Respiration Waveforms Apnea Blood Pressure waveforms Temperature Calibration Specifications Accessories Appendix 15 17 21 27 28 29 30 30 34 35 GENERAL DESCRIPTION The Rigel 333 Multi Parameter Patient Simulator is an advanced micro controller based instrument It is designed to simulate patient signals of ECG arrhythmia invasive blood pressure respiration and temperature The device also simulates square sine triangle and pulse performance waveforms The easy to operate Rigel 333 is menu driven via eight tactile feel soft keys All functions are displayed on a two line sixteen character LCD display The small hand held instrument is powered by one 9 Volt battery or an optional AC adapter The Rigel 333 is CE marked and shipped with a Certificate of Calibration traceable to the NIST The Rigel 333 is a rugged instrument that perf
15. eir abbreviations definitions and default settings SIMULATOR MENU Ecg Resp Bp Temp Ecg ECG Default Setting Normal Sinus Rhythm NSR at 80 BPM with Amplitude of 1 mV Resp Respiration Default Setting 30 BPM Impedance 500 Ohms Delta R 1 0 Ohm and Apnea Off Bp Blood Pressure Default Setting 120 80 Dynamic Setting 0 Static Setting Temp Temperature Default Setting YSI 700 series set to 25 C YSI 400 series set to 25 C Base Perf Arth Aut ECG Menu Base Perf Arth Aut Baseline ECG Performance Waveforms Arrhythmia Waveforms Automatic Test Sequences Baseline ECG NSR PCR ST RWD Normal Sinus Rhythm Pacer Waveforms ST Segment Analysis Waveforms R Wave Detection NSR Rate Ampl Rate and Amplitude selections under NSR are Rate Ampl 30 60 70 80 90 100 120 150 180 210 240 270 300 350 15 0 3 0 5 1 0 10 2 0 3 0 4 0 5 0 Pacer Waves Atr Vent Selecting Atr branches to Atr_Pcr Waves ve AP PCR ASP ve Changes pacer pulse from positive ve to negative ve AP Atrial Pacer Normal Paced Rhythm QRS with rate of 60 BPM and Pacemaker pulses with amplitudes of 2 mV and 2 mV with duration of 0 1 ms or 2 ms with a normally paced QRS T QRS amplitude of 1 mV duration of 100 ms T wave amplitude of 0 2 mV duration of 180 ms and Q T interval of 350ms PCR Pacer Pulses Alone Amplitude default setting of 1 0 mV and width of 1 0 ms Widt width selections 0 1 0
16. illator Testers e Patient Simulators For a full list of products please order a free copy of our product catalogue online at www rigelmedical com Rigel Medical Seaward Group 18 Bracken Hill Peterlee County Durham SR8 2SW England Phone 44 191 5863511 e Fax 44 191 5860227 www rigelmedical com 36 Rigel 333 Manual Rev 2 0 37
17. itten permission from Rigel Medical Quality Assurance Seaward Electronic Ltd is ISO 9001 2000 Registered This instrument was thoroughly tested and inspected according to Seaward s ISO 9001 2000 quality standards and test procedures and was found to meet those specifications when it was shipped from the factory Warranty Rigel Medical warranties the Rigel 333 Multi Parameter Patient Simulator against defects in materials and workmanship for one year from the date of original purchase During the warranty period we will repair or at our option replace at no charge a product that proves to be defective provided you return the product shipping prepaid to Rigel Medical 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 Rigel Medical or if its serial number is defaced or removed Rigel Medical reserves the right to discontinue the Rigel 333 at any time and change its specifications price or design without notice and without incurring any obligation Rigel Medical guarantees availability of service parts for 5 years after the manufacture of the unit is discontinued The warranty is void if you elect to have the unit serviced and or calibrated by someone other than Rigel Medical The purchaser assumes all liability for any damages or bodily injury that may result from the use or misuse of the unit by the purchaser his employ
18. orms its simulations quickly accurately and with ease CONTROLS AND INDICATORS On Off Key ECG Lead Snaps LCD Display Temperature Connector Blood Pressure Connector Hi Level ECG Output Function Keys F1 F2 F3 FL Arrow Keys lt and gt Menu Key CHAIDAMERWNE OPERATING INSTRUCTIONS The operating menu of the Rigel 333 is arranged in a tree structure When turned on the micro controller initialises a test routine and displays the model and software version numbers and then switches to the Main Menu During operation the MENU key returns the currently displayed menu to the previous menu The F1 F2 F3 and F keys sdect the parameter for simulation the specific type of parameter and the functional characteristics of the parameter The lt and gt arrow keys move through the available choices under the selected parameter Basic Operating Instructions 1 Connect the Rigel 333 to a patient monitor using the ECG lead snaps correct blood pressure interface cable and correct temperature interface cable Turn the Rigel 333 On Select the parameter for simulation ECG Resp BP or Temp oo N 8 4 Continue to select choices under the parameter to be simulated until the functional characteristics have been chosen 5 Each Parameter has default settings The following are the menu sequence displays th
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