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Fluke Biomedical ProSim 8 Series, User Manual

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Fluke Biomedical ProSim 8 Series User Manual Download Page 4

Certification 

This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomedical’s manufacturing 

specifications when it was shipped from the factory. Calibration measurements are traceable to the National 

Institute of Standards and Technology (NIST). Devices for which there are no NIST calibration standards are 

measured against in-house performance standards using accepted test procedures. 

WARNING 

Unauthorized user modifications or application beyond the published specifications may result in electrical shock 

hazards or improper operation. Fluke Biomedical will not be responsible for any injuries sustained due to 

unauthorized equipment modifications. 

Restrictions and Liabilities 

Information in this document is subject to change and does not represent a commitment by Fluke Biomedical. 

Changes made to the information in this document will be incorporated in new editions of the publication. 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. 

Manufacturing Location 

The ProSim™ 8 Vital Signs Simulator is manufactured at Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A. 

Summary of Contents for ProSim 8 Series

Page 1: ...v 3 3 16 2011 2016 Fluke Corporation All rights reserved Specifications are subject to change without notice All product names are trademarks of their respective companies ProSim 8 Vital Signs Simulat...

Page 2: ...ke Biomedical service facility NO OTHER WARRANTIES SUCH AS FITNESS FOR A PARTICULAR PURPOSE ARE EXPRESSED OR IMPLIED FLUKE SHALL NOT BE LIABLE FOR ANY SPECIAL INDIRECT INCIDENTAL OR CONSEQUENTIAL DAMA...

Page 3: ...s or if there are any other problems not caused by shipping damage please contact Fluke Biomedical or your local sales representative Returns and Repairs Return Procedure All items being returned incl...

Page 4: ...esult in electrical shock hazards or improper operation Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modifications Restrictions and Liabilities Inf...

Page 5: ...Arrhythmias 20 Pacemaker Waveforms 20 Advance Cardiac Life Support ACLS Waveforms 22 ECG Performance Tests 22 Set a Performance Wave 22 Set R Wave Detection Values 24 Set QRS Detection Test Values 25...

Page 6: ...mits Test 65 Pulse Rate Test 65 Pulse Amplitude Test 65 Autosequences 65 View the Steps of an Autosequence 68 Do an Autosequence 69 Save and View Test Results 70 Make an Operator ID 71 Make a Test ID...

Page 7: ...ntinued iii Temperature 88 Cardiac Output 88 Non Invasive Blood Pressure 89 Oximeter SpO2 Optical Emitter and Detector optional 89 Pre Defined Simulations 90 Autosequences default 90 Glossary A1 Intro...

Page 8: ...ProSim 8 Users Manual iv...

Page 9: ...ories 5 5 Top Panel Controls and Connections 6 6 Back Front and Side Panel Connections 7 7 Pre Defined Patient Simulations 10 8 ECG Wave Groups 13 9 ECG Lead Amplitudes 14 10 Arrhythmias by Wave Group...

Page 10: ...ProSim 8 Users Manual vi...

Page 11: ...Blood Pressure Connections 33 19 Initial Swan Ganz Procedure Simulation Screen 34 20 Insert Step in Swan Ganz Procedure Simulation 34 21 Aortic Valve Catheterization Simulation Screen 36 22 Pulmonary...

Page 12: ...imeter SpO2 Optical Emitter and Detector Connections 60 46 SpO2 Sensor Placement 61 47 Magnetic Holder for SpO2 Artificial Finger 62 48 Autosequence Start Screen 69 49 Autosequence Step Screen 69 50 M...

Page 13: ...n optical signal to verify that the electronics within the pulse oximeter probe are functional Table 1 Simulation Types Parameter Simulation Type ECG Electrical Respiration Electrical Temperature Elec...

Page 14: ...st or cause permanent loss of data XW Warnings To prevent personal injury use the Product only as specified or the protection supplied by the Product can be compromised To prevent possible electrical...

Page 15: ...Symbols Table 2 describes symbols used in association with the Product Table 2 Symbols Symbol Description Symbol Description W WARNING RISK OF DANGER Consult user documentation X WARNING HAZARDOUS VOL...

Page 16: ...battery before the first use Afterwards charge the battery when the Product shows the low battery message See Battery Maintenance Accessories Available Product accessories are shown in Tables 3 and 4...

Page 17: ...985658 SpO2 Masimo RAINBOW cable 4034609 Battery pack 4021085 NIBP Test 500 mL rigid chamber 4034611 Simulation Cables IBP Temperature See your Fluke Biomedical Distributor Cardiac Output Interface Bo...

Page 18: ...s SETUP Button Accesses the setup controls IBP Button Accesses the Invasive Blood Pressure IBP functions Navigation Buttons Cursor control buttons for navigating menus and lists Enter Button Sets the...

Page 19: ...s when LED shows red Green shows battery charge is complete Battery Latch Locks the battery pack into the Product Push down to remove the battery pack Mini B USB Device Port Used to connect to a PC fo...

Page 20: ...ns Waveform and ECG rate parameters are set through the ECG function See ECG Function to learn more on how to set these variables The respiration rate Resp Rate temperature parameter cardiac output an...

Page 21: ...Sim Mini Plug In on the PC to communicate with the Product Note You must have Ansur Test Executive version 2 9 6 on your PC to communicate with the Product To connect the Product to a PC Connect a USB...

Page 22: ...e Form NSR Adult ECG Rate 60 BPM Respiration Rate 20 brpm Temperature 37 0 C IBP Channel 1 120 80 mmHg Art IBP Channel 2 28 15 mmHg PA NIBP 120 80 93 mmHg SpO2 97 Hypertensive Wave Form NSR Adult ECG...

Page 23: ...g NIBP 0 0 mmHg SpO2 50 After you set one of the pre defined simulations you can change the parameters of one or all of the vital signs Changes are not kept in the Product The pre defined simulation p...

Page 24: ...of a monitor connect the Product to the monitor as shown in Figure 4 You can connect a maximum of ten ECG leads to the Product ProSim 8 Patient Monitor ECG Cable glh030 eps Figure 4 ECG Connections S...

Page 25: ...ction Supraventricular Arrhythmia waveforms See Simulate Arrhythmias Premature Ventricular Conduction TV Paced ACLS 4 When the Waveform Group value is highlighted push To change the heart rate 1 Push...

Page 26: ...de value 2 Push 3 Push or to adjust the amplitude Each push of a key increases or decreases the amplitude 0 05 mV between 0 05 mV and 0 50 mV and 0 25 mV above 0 50 mV to 5 00 mV in the direction of t...

Page 27: ...er of different ECG artifacts that can change the accuracy of an ECG indication You can add several ECG artifact simulations to an ECG wave line frequency artifacts of 60 Hz U S lines and 50 Hz Europe...

Page 28: ...entricular Premature Ventricular Conduction TV Paced and ACLS Table 10 shows all the arrhythmias the Product can simulate and identifies in which wave group they can be found The table also identifies...

Page 29: ...Tach ACLS Pulseless Elect Tach ACLS PVCs Ventricular PVC1 Left Vent Premature PVC1 LV Early Premature PVC1 LV R on T Premature PVC2 Right Vent Premature PVC2 RV Early Premature PVC2 RV R on T Prematur...

Page 30: ...ariable to coarse or fine To change the type variable with the atrial fibrillation waveform set 1 Push or to highlight the Type value 2 Push 3 Push or to highlight Coarse or Fine from the list 4 Push...

Page 31: ...s To change the type variable for the ventricular fibrillation and poly V tach waveform set 1 Push or to highlight the Type value 2 Push 3 Push or to highlight Coarse or Fine from the list 4 Push to s...

Page 32: ...artifacts to each arrhythmia signal See Simulate an ECG Artifact Pacemaker Waveforms The Product can simulate ECG waveforms with a number of artificial pacemaker conditions Table 11 shows the simulati...

Page 33: ...pacemaker variables except for the Atrial 80 BPM waveform The Atrial 80 BPM has an atrial pacemaker value The Atr Vent Sequential waveform has an atrial pacemaker value and a ventricle pacemaker value...

Page 34: ...As well as physiological waveforms the Product can supply signals to measure the performance of an ECG monitor A set of performance waveforms are used to measure the frequency response high and low s...

Page 35: ...ght a value in the rate list Table 12 lists the rates for each type of wave Table 12 Performance Wave Rates Performance Wave Rates Square and Triangle 0 125 2 0 and 2 5 Hz Sine 0 05 0 5 1 2 5 10 25 30...

Page 36: ...gure 9 on the display glh020 bmp Figure 9 R Wave Detection Screen You can change the rate amplitude and width of the R wave To change the rate 1 Push or to highlight the Rate value 2 Push 3 Push or to...

Page 37: ...ified in EC 13 The R wave is 0 875 of the waveform amplitude and the S wave is negative at 0 125 of the waveform amplitude The R wave up slope is 0 4375 of the waveform width The R wave down slope is...

Page 38: ...is 20 ms or less The Product simulates a QT width of 8 ms to 200 ms 7 When the width is set push to enter the value and go back to the ECG QRS Detection screen Set Tall T Wave Rejection Test Values An...

Page 39: ...te The maternal heart rate is always a normal sinus rhythm at 80 beats minute The Product does not provide simulations for all types of fetal heart rate tracings and contraction patterns A few example...

Page 40: ...te Intrauterine Pressure IUP The simulated intrauterine pressure IUP waveform shows a measurement read by an intra amniotic catheter connected to a pressure transducer The Product simulates the IUP on...

Page 41: ...Jumper Wires BP Cable IBP Channel 1 glh058 eps Figure 13 Fetal Monitor Connections for Intrauterine Pressure Simulation Note The maternal thigh reference plate is an accessory provided by fetal monit...

Page 42: ...pressure by 45 seconds The fetal heart rate starts at 140 BPM slows to 100 BPM and then goes back to 140 BPM With acceleration the change in fetal heart rate lags the change in intrauterine pressure...

Page 43: ...p softkey to stop contractions and go back to the Fetal ECG IUP screen Invasive Blood Pressure Simulation and Tests The Product simulates blood pressure for Invasive blood pressure monitors You can se...

Page 44: ...ey After you zero the product do the zero function on the patient monitor To set the pressure 1 Push or to highlight the Pressure value on Channel 1 or Channel 2 2 Push Systolic and diastolic pressure...

Page 45: ...values Highlight Off to turn off the artifact function Note The artifact values show in percent or in mmHg These units are set by the chamber value 4 Push to set the artifact value and go back to the...

Page 46: ...To move to the subsequent step push the Next softkey After the first step push the Previous softkey to go back a step To stop the procedure push the Stop softkey To do the steps automatically push th...

Page 47: ...oss the valve is used to determine heart valve condition To simulate a Cardiac Catheterization procedure 1 Push the Tests softkey in the IBP screen 2 Push or to highlight Cardiac Catheterization 3 Pus...

Page 48: ...on Screen For a normal valve when the heart beat starts the LV pressure increases to 80 mmHg Then as the valve opens both pressures increase to the systolic peak Next the pressures fall until the valv...

Page 49: ...rmal valve when the heart beat starts the RV pressure increases to 10 mmHg Then as the valve opens both pressures increase to the systolic peak Next the pressures fall until the valve opens The RV pre...

Page 50: ...tion 1 Push the Insert softkey to simulate a change in IBP channel 2 catheter pressure to the pulmonary artery wedge pressure PAW of 10 2 glh056 bmp Figure 23 Mitral Valve Catheterization Simulation S...

Page 51: ...rature jack as shown in Figure 24 ProSim 8 Patient Monitor Temperature Cable glh038 eps Figure 24 Temperature Simulation Connection To set the simulated temperature 1 Push 2 Push or to highlight the T...

Page 52: ...dance variation respiration amplitude are set though the front panel as well To set respiration between normal and ventilated 1 Push or to highlight the Wave value 2 Push 3 Push or to highlight Normal...

Page 53: ...r LL in the list 4 Push to set the respiration lead and go back to the Respiration screen The respiration lead is kept in memory and is non volatile Note Respiration lead value is kept in memory and i...

Page 54: ...ent under test and simulates the injectate temperature IT thermistors at 0 C or 24 C Of the two connectors on the CI 3 module cable the smaller 3 pin connector is for catheter blood temperature BT and...

Page 55: ...NNECTION 3 Solder wires to pins 1 and 3 eic224 eps Figure 26 Cardiac Output Injectate Cable Modification Note Fluke Biomedical offers optional adapter cables to connect the Product to specified brands...

Page 56: ...imulated parameters that follow Catheter Size 7 F Injectate Volume 10 cc Computational Constant 0 542 or 0 595 based on the injectate temperature To set the Product for a cardiac output test 1 Push 2...

Page 57: ...back to the Cardiac Output screen Set the Baseline Temperature To set the baseline temperature 1 In the cardiac output screen if not already highlighted use or to highlight the baseline temperature va...

Page 58: ...ct to measure static pressure and shows the pressure on the display Set the Non Invasive Blood Pressure Variables For non invasive blood pressure tests connect the Product to the BP cuff and monitor a...

Page 59: ...pressure cuff mandrel sizes Large Adult Adult Cap Cap Small Adult Child Small Child Neonatal fcv011 eps Figure 30 Blood Pressure Cuff Mandrel Sizes To set the blood pressure simulation push to show t...

Page 60: ...t show in the NIBP screen if an arrhythmia or performance waveform is set To set the heart rate 1 Push or to highlight the Heart Rate variable 2 Push 3 Push or to increase or decrease the heart rate i...

Page 61: ...ave variable 1 Push or to highlight the Wave variable 2 Push 3 Push or to highlight Adult or Neonatal 4 Push to set the wave and go back to the NIBP screen When the NIBP monitor starts the blood press...

Page 62: ...ressure envelope to the left The default value for a shift is zero and the range is from 10 to 10 In Figure 33 the top graph shows a blood pressure envelope with a negative shift and the bottom graph...

Page 63: ...The graph shows on the display automatically only when the blood pressure measurement cycle starts when the NIBP screen shows on the display The Product starts blood pressure simulation when the pres...

Page 64: ...stem Refer to the service manual for the NIBP monitor Connect the Product to the monitor and cuff as shown in Figure 35 Mandrel Blood Pressure Cuff Wraps around mandrel ProSim 8 Patient Monitor Dual h...

Page 65: ...et the target pressure between 20 mmHg and 400 mmHg To change the target pressure push or to increase or decrease the pressure value in 1 mmHg steps Note When you hold down the direction key the step...

Page 66: ...back to the NIBP Leak Test screen Do a Pressure Relief Test The pressure relief test pressurizes a pneumatic system until the Product senses a drop in pressure as occurs when the relief valve opens O...

Page 67: ...no drop in pressure and the pressure climbs to the target pressure the pump stops and Not Tripped shows in the display Note Some NIPB monitors do not let you access a Service mode If you cannot close...

Page 68: ...ource test 1 Connect the pressure port to pressure system as shown in Figure 40 ProSim 8 Mandrel Blood Pressure Cuff Wraps around mandrel Blood Pressure Gauge glh051 eps Figure 40 Pressure Source Conn...

Page 69: ...y shows on the display The pressure remains at the level it was when the Stop softkey was pushed 8 Either push the Vent softkey to vent the pressure system or change the pressure and push the Start so...

Page 70: ...sh the Tests softkey 3 Push or to highlight Manometer 4 Push 5 Push Zero Pressure Oximeter SpO2 Optical Emitter and Detector The subject device provides Oximeter SpO2 optical emitter and detector capa...

Page 71: ...are compatible Functional testers can vary in pulse methods pulse contours and amplitude A functional tester might not accurately reproduce the calibration of the pulse oximeter equipment and can yie...

Page 72: ...t the oximeter sensor on the artificial finger make sure the red LEDs light emitting diodes are on the bottom Put the SpO2 sensor on the artificial finger as shown in Figure 46 Place the sensor with t...

Page 73: ...roSim Oximeter SpO2 Optical Emitter and Detector Adjust finger on the display for maximum signal SpO2 Cable Pulse Oximeter Sensor To Patient Monitor glh048 eps Figure 46 SpO2 Sensor Placement Attach t...

Page 74: ...he SpO2 value in 1 steps between 30 and 100 4 Push to set that SpO2 value and go back to the SpO2 screen To change the pulse amplitude value 1 Push or to highlight the Pulse Amplitude value 2 Push 3 P...

Page 75: ...ushed The range is 10 BPM to 300 BPM 4 Push to go back to the SpO2 screen To change SpO2 respiration 1 From the SpO2 screen push the or to highlight the Respiration value 2 Push 3 Push or to highlight...

Page 76: ...o Rainbow SpO2 When you set the SpO2 type parameter to Masimo Rainbow you must connect the Product to the monitor with the optional SpO2 Masimo Rainbow cable See Table 4 for a part number The SpO2 scr...

Page 77: ...the heart rate until the alarm sounds You can decrease the heart rate to 0 BPM to simulate asystole or no pulse Pulse Amplitude Test You can increase or decrease the peak to peak amplitude of the bloo...

Page 78: ...G 30 BPM IBP1 60 30 Art IBP2 60 0 LV SpO2 50 NIBP 60 30 Respiration 10 brpm and Temperature 34 C 01 00 REPEAT Total Time 03 00 Oximeter Testing SpO2 100 Pulse Amplitude 20 Transmissivity normal adult...

Page 79: ...0 20 Ventricular Bigeminy 00 20 TV Paced Asynchornous 75 BPM 00 15 Ventricular Asystole 00 15 Conduction Lt Bndl Branch Block 00 15 Ventricular Run of PVCs 00 30 Supraventricular Atrial Fibrillation 0...

Page 80: ...e Rate 150 Hz Amplitude 1 0 mV 00 05 Waveform Triangle Rate 0 125 Hz Amplitude 1 0 mV 00 05 Waveform Triangle Rate 2 0 Hz Amplitude 1 0 mV 00 05 Waveform Pulse Rate 60 BPM Amplitude 1 0 mV 00 05 REPEA...

Page 81: ...es do The screen also shows the four step sequence takes 1 minute and 20 seconds to complete Each sequence step shows on the display When there are more steps than can show in one display screen push...

Page 82: ...screen You cannot change a pre defined autosequence or rename it But you can use the Ansur functionality to copy an autosequence make changes and then put it into the Product as a new custom autosequ...

Page 83: ...to add the highlighted character to the operator ID 7 Do steps 5 and 6 for each character in the operator ID You can have the maximum number of characters that fit in the test ID field on the display...

Page 84: ...list 3 Push to open the Test ID screen 4 Push the New Test ID softkey 5 Push and to highlight a character for the test ID 6 Push to add the highlighted character to the test ID 7 Do steps 5 and 6 for...

Page 85: ...y Note If there is more than one simulation parameter you have to highlight a parameter and push before the next step 3 Push or to set the parameter to the value observed on the UUT 4 Push to set the...

Page 86: ...perature screen View Test Results To view the test results in memory 1 Push 2 Push and to highlight View Memory 3 Push Note If no test results data is saved to memory an error message shows on the dis...

Page 87: ...t Results Data Screen Print Test Results With a PCL5 compatible printer connected to the USB A Controller Port you can print a test results record Note A compatible printer must be connected to the Pr...

Page 88: ...record 7 Push the Delete softkey to delete the test ID record A Confirm Delete screen shows on the display with a Delete Record message When you push the Yes softkey the test ID record is deleted from...

Page 89: ...he Date Time Settings screen To set the date format 1 Push or to highlight the Date Format value 2 Push 3 Push or to highlight the Date Format value 4 Push to set the date and go back to the Date Time...

Page 90: ...Push or to highlight the Volume value 2 Push 3 Push or to highlight the Volume value 4 Push to set the volume and go back to the Sound Settings screen Set the Pressure Units and IBP Sensitivity The un...

Page 91: ...ettings screen To set the battery charger 1 Push or to highlight the Charge Battery value 2 Push 3 Push or to highlight Yes or No 4 Push to set the charger value and go back to the Battery Settings sc...

Page 92: ...y test elements used by Ansur Executive that use the same user interface for all analyzers and simulators supported by an Ansur plug in When you purchase a new Fluke Biomedical analyzer or simulator y...

Page 93: ...tion may force the cleaning fluid into the Product and damage electronic components Clean the Product occasionally with a damp cloth and mild detergent Try to prevent the entrance of liquids Clean the...

Page 94: ...the ac dc power supply to a power source Note When the battery pack is installed in the Product ensure the battery charger is enabled See Set Battery Settings to enable and disable the battery charger...

Page 95: ...e battery pack latch as shown in Figure 61 2 Remove the battery pack from the Product Push Down Pull Out glh046 eps Figure 61 Battery Removal To put the battery pack into the Product align the battery...

Page 96: ...W Safety IEC 61010 1 Overvoltage Category II Pollution Degree 2 Electromagnetic Compatibility EMC International IEC 61326 1 Portable Electromagnetic Environment CISPR 11 Group 1 Class A Group 1 Equipm...

Page 97: ...05 mV to 0 5 mV 0 05 mV steps 0 5 mV to 5 0 mV 0 25 mV steps Other leads are proportional to Lead II reference lead in percentage per Lead I 70 Lead II 100 Lead III 30 Lead V1 24 Lead V2 48 Lead V3 10...

Page 98: ...Ventricular fibrillation coarse ventricular fibrillation fine unstable polymorphic ventricular tachycardia Non Shockable Pulseless Arrest Rhythms Asystole Symptomatic Bradycardia Sinus Bradycardia 60...

Page 99: ...respiration Size 25 50 100 of the normal sinus R Wave for each lead Lead Select All RA LL LA V1 V2 V3 V4 V5 V6 Fetal Maternal ECG Fetal Heart Rate Fixed 60 BPM to 240 BPM in 1 BPM steps Fetal Heart Ra...

Page 100: ...1 00 in 0 05 steps and 1 00 to 5 00 in 0 25 steps Delta Accuracy 5 of setting 0 1 Baseline 500 1000 default 1500 2000 Leads I II III Baseline Accuracy 5 Respiration Lead LA or LL default Apnea Selecti...

Page 101: ...1 25 ml 180 BPM Arrhythmias Premature atrial contraction PAC Premature ventricular contraction PVC atrial fibrillation and missed beat Leak Test Target Pressure 20 mmHg to 400 mmHg Elapsed time 0 30 m...

Page 102: ...50 Hz 60 Hz and 1 kHz to 10 kHz in 1 kHz steps Masimo Rainbow Technology Masimo Rainbow technology with an optional adapter supplied by Masimo that allows the ProSim two wavelength to test the Rainbo...

Page 103: ...nt which when flowing in straight parallel wires of infinite length and negligible cross section separated by a distance of one meter in free space produces a force between the wires of 2 10 7 newtons...

Page 104: ...entricular asystole is a critical condition characterized by the absence of a heartbeat either in the ventricles or in the entire heart This condition also referred to as cardiac standstill is usually...

Page 105: ...in one second Bigeminy Two sequences a PVC followed by a normal beat or a PVC followed by two normal beats Bigeminy also called a fixed coupling or bigeminal rhythm is a type of PVC in which a beat w...

Page 106: ...T waveform Frequent Multifocal PVCS A sequence that includes a left focus PVC followed by normal beats alternating with a right focus PVC followed by normal beats Frequent multifocal PVCs are initiat...

Page 107: ...h equivalent to 39 37 inches in the metric system Millivolt One thousandth of a volt Missed Beat A single missing beat with the heart rate returning to normal Missed beats often present in first degre...

Page 108: ...by a premature atrial contraction PAC PAT spasms may last for only a few seconds or for minutes or hours A patient may experience ATs and PATs over the course of many years PCWP Pulmonary capillary w...

Page 109: ...wave of the preceding QRS T complex are especially inauspicious because of their potential to cause ventricular tachycardia or ventricular fibrillation Pulse The rhythmical throbbing of arteries prod...

Page 110: ...ar Tachycardia Normal rhythm at a faster than normal rate of 200 BPM Supraventricular tachycardia is a combination of a junctional tachycardia that is an atrial tachycardia occurring in the AV or junc...

Page 111: ...originating in the ventricles similar to type 1 left focus PVCs Ventricular tachycardia is a life threatening arrhythmia in which one or multiple ectopic ventricular pacemakers in the bundle branches...

Page 112: ...ProSim 8 Users Manual A 10...

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