Vital Signs Simulator

ProSim 8

Technical Data
The 8-in-1 ProSim 8 Vital Signs Simulator offers fast and comprehensive preventative maintenance (PM) testing for your entire patient monitor fleet. Designed to get you in and out of most PM locations in minutes, this multifunction simulator tests ECG (including fetal ECG and arrhythmias), respiration, temperature, IBP, cardiac output/cardiac catheterization, NIBP, SpO2, and is capable of simulating Rainbow multi-wavelength waveforms. Featuring specialized stay-connected ECG posts for secure lead connections, physiologically-synchronized pulses across all parameters, and customizable patient pre-sets and autosequences, the ProSim 8 patient simulator provides unbeatably fast and easy complete monitor testing. Barcode-scanner compatibility and wireless PC interface, direct printing, data transfer and reporting, along with advanced, integrated technologies and works-every-time performance allow top confidence in patient monitor fleet performance and supports passing regulatory audits with ease.

Key features
All-in-one complete monitor testing 80 % smaller and 17 lbs/7.7 kilos lighter than predecessor technology 8-in-1 multifunction simulator tests ECG (including fetal ECG and arrhythmias), respiration, temperature, IBP, cardiac output/cardiac catheterization, NIBP, SpO2, and Rainbow multi-wavelength waveforms Stay-connected ECG posts for easy/secure ECG snap and lead connections Custom SpO2 r-curve for accurate testing of the latest and future oximetry technologies Static pressure linearity testing Repeatable NIBP simulation (+/- 2 mmHg) for dynamic pressure repeatability testing Physiologically synchronized pulses across all parameters Barcode scanning and direct data capture and printing functionality Onboard, customizable patient pre-sets and autosequences for fast/easy testing Multi-language user interface offers choice of language selection Integrated, easily-replaceable long-life battery Optional PC-interface software offers customizable procedures/checklists to replace bulky service manuals and automated data capture/storage Wireless communication for remote PC control of test device, as well as data transfer and automated regulatory reporting

Specifications
General specifications
Temperature Humidity Altitude Dimensions (L x W x H) Display Communication Operating Storage 10 % to 90 % non-condensing 3,000 meters (9,843 ft) 14.5 cm x 30.2 cm x 8.6 cm (5.7 in x 11.9 in x 3.4 in) LCD color display USB device upstream port USB host controller port Mini-B connector for control by a computer Type A, 5 V output, 0.5 A max load. Connector for keyboard, barcode reader, and printer IEEE 82.15.4 for control by a computer 10 C to 40 C (50 F to 104 F) -20 C to +60 C (-4 F to 140 F)

Wireless Power Battery charger Lithium-ion rechargeable battery

100 V to 240 V input, 15 V/2.0 A output. For best performance, the battery charger should be connected to a properly-grounded ac receptacle 9 hours (minimum), 100 NIBP cycles typical 1.87 kg (4.2 lb) EN/IEC 61010-1:2001 CE, CSA, C-TICK N10140 , RoHS IEC 61326-1:2006

Battery life Weight Safety standards Certifications Electromagnetic compatibility (EMC)

2 Fluke Biomedical

ProSim 8 Vital Signs Simulator

Detailed specifications
Normal-sinus-rhythm waveform ECG reference Normal sinus rhythm The ECG amplitudes specified are for Lead II (calibration), from the baseline to the peak of the R wave. All other leads are proportional 12-lead configuration with independent outputs referenced to right leg (RL). Output to 10 universal ECG jacks, color-coded to AHA and IEC standards 0.5 V/mV 5 % of the ECG amplitude setting available on a BNC connector 0.05 mV to 0.5 mV (0.05 mV steps); 0.5 mV to 5 mV (0.25 mV steps) (2 % of setting + 0.05 mV) 10 BPM to 360 BPM in 1 BPM steps 1 % of setting Adult (80 ms) or pediatric (40 ms) QRS duration Adult mode only. -0.8 mV to +0.8 mV (0.1 mV steps). Additional steps: + 0.05 mV and - 0.05 mV 60 BPM, 1.0 mV, adult QRS and ST-segment elevation of 0 mV Amplitude 0 (off), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 50, 100, 200, 500, and 700 mV for lead II (reference lead) Reference lead II: (5 % setting + 0.2 mV) All other leads: (10 % setting + 0.4 mV) Pacer pulse width Paced arrhythmias 0.1 ms, 0.2 ms, 0.5 ms, 1 ms, and 2 ms 5 % Atrial 80 BPM Asynchronous 75 BPM Demand with frequent sinus beats Demand with occasional sinus beats Atrio-ventricular sequential Noncapture (one time) Nonfunction Power-on default Amplitude 5 mV, width 1 ms, atrial waveform

High-level output Amplitude Amplitude accuracy ECG rate Rate accuracy ECG waveform selection ST-segment elevation Power-on default Pacemaker waveform Pacer pulse

Accuracy

3 Fluke Biomedical

ProSim 8 Vital Signs Simulator

Arrhythmia Baseline NSR PVC focus Supraventricular arrhythmia 80 BPM Left focus, standard timing (except where specified) Atrial fibrillation (coarse or fine); atrial flutter; sinus arrhythmia; missed beat (one time); atrial tachycardia; paroxysmal atrial tachcardia; nodal rhythm; and supraventricular tachycardia Premature atrial contraction (PAC); premature nodal contraction (PNC); PVC1 left ventricular; PVC1 left ventricular, early; PVC1 left ventricular, R on T; PVC2 right ventricular; PVC2 right ventricular, early; PVC2 right ventricular, R on T; and multifocal PVCs PVCs 6, 12, or 24 per minute; frequent multifocal PVCs; bigeminy; trigeminy; multiple PVCs (one-time run of 2, 5, or 11 PVCs); monoventricular tachycardia (120 to 300 BPM in 5 BPM steps); poly-ventricular tachycardia (5 types); ventricular fibrillation (coarse or fine); and asystole First-, second-, or third-degree heart block; and right- or left-bundlebranch block Shockable pulseless arrest rhythms Ventricular fibrillation (coarse), ventricular fibrillation (fine), unstable polymorphic ventricular tachycardia Asystole Sinus bradycardia (< 60 BPM) 2nd degree AV block, mobitz type I 2nd degree AV block, mobitz type II Complete/3rd degree AV block Right bundle branch block Left bundle branch block
cont.

Premature arrhythmia

Ventricular arrhythmia

Conduction defect Advanced cardiac life support

Non-shockable pulseless arrest rhythms Symptomatic bradycardia

Advanced cardiac life support

Symptomatic tachycardia: regular Sinus tachycardia > 150 BPM narrow-complex tachycardia (QRS Supraventricular Tachycardia < 0.12 seconds) Symptomatic tachycardia: regular wide-complex tachycardias (QRS 0.12 seconds) Irregular tachycardia Sinus tachycardia > 150 BPM Supraventricular tachycardia SVT with aberrancy Atrial fibrillation (coarse and fine), atrial flutter, unstable monomorphic ventricular tachycardia (120 BPM to 300 BPM), torsade de pointes/polymorphic ventricular tachycardia (long QT interval)

4 Fluke Biomedical

ProSim 8 Vital Signs Simulator

ECG Performance testing Amplitude Pulse wave Square wave Triangle wave Sine wave R-wave detection 0.05 mV to 0.5 mV (0.05 mV steps) 0.5 mV to 5 mV (0.25 mV steps) 30 BPM, 60 BPM, with 60 ms pulse width 0.125 Hz, 2 Hz, 2.5 Hz 0.125 Hz, 2 Hz, 2.5 Hz 0.05 Hz, 0.5 Hz, 1, 2 Hz, 5 Hz, 10 Hz, 25 Hz, 30 Hz, 40 Hz, 50 Hz, 60 Hz, 100 Hz, and 150 Hz Waveform Rate Width Width accuracy QRS detection Widths Width accuracy Rate R-Wave up slope R-Wave down slope S-Wave up slope Tall T-wave rejection Waveform Triangular pulse 30 BPM, 60 BPM, 80 BPM, 120 BPM, 200 BPM, and 250 BPM 8 ms to 20 ms in 2 ms steps, and 20 ms to 200 ms in 10 ms steps (1 % of setting + 1 ms) 8 ms to 20 ms in 2 ms steps, and 20 ms to 200 ms in 10 ms steps (1 % of setting + 1 ms) 30 BPM, 60 BPM, 80 BPM, 120 BPM, 200 BPM, and 250 BPM 0.875 amplitude, 0.4375 x width Full amplitude, 0.5 x width 0.125 amplitude, 0.0625 x width QT Interval 350 ms T-Wave width 180 ms T-Wave shape sinewave Amplitude Rate Rate accuracy Amplitute accuracy ECG artifact Type Size Lead select 50 Hz, 60 Hz, muscular, baseline wander, respiration 25 %, 50 %, 100 % of the normal sinus R-Wave for each lead All, RA, LL, LA, V1, V2, V3, V4, V5, V6 1 % of setting (2 % of setting + 0.05 mV) 0 % to 150 % reference lead amplitude in 10 % steps 80 BPM

5 Fluke Biomedical

ProSim 8 Vital Signs Simulator

Fetal/Maternal ECG Fetal heart rate (fixed) Fetal heart rate (IUP) Intrauterine-pressure waveforms Wave duration IUP period Default settings Invasive blood pressure Channels Input/output impedance Exciter input range Exciter-input frequency range Transducer sensitivity Pressure accuracy Static pressure Pressure units Dynamic waveforms 2, each independently settable with identical parameters and are individually electrically isolated from all other signals 300 10 % 2 to 16 V peak DC to 5000 Hz 5 (default) or 40 V/V/mmHg (1 % of setting + 1 mmHg) accuracy guaranteed for dc excitation only - 10 to + 300 mmHg in 1 mmHg steps mmHg or Kpa Types (default pressures Arterial (120/80) Radial artery (120/80) Left ventricle (120/00) Right ventricle (25/00) Pulmonary artery (25/10) Pulmonary-artery wedge (10/2) Right atrium (central venous or CVP) (15/10) Pressure variability Systolic and diastolic pressures are independently variable in 1 mmHg steps 60 BPM to 240 BPM in 1 BPM steps 140 BPM at beginning, then varies with pressure Early deceleration, late deceleration, and acceleration 90 seconds, bell-shaped pressure curve, from 0 mmHg to 90 mmHg and returning to 0 2 min, 3 min, or 5 minutes; and manual FHR 120 BPM, early deceleration wave, manual

Swan-Ganz sequence Cardiac catheterization Respiration artifact

Right atrium, right ventrical (RV), pulmonary artery (PA), pulmonary artery wedge (PAW) Chambers Arterial, radial artery, and left ventricle Other Circular DIN 5-Pin 0 mmHg Aortic, pulmonary valve, and mitral valve 5 % to 10 % multiplication 5 mmHg or 10 mmHg

BP output Power-on default

6 Fluke Biomedical

ProSim 8 Vital Signs Simulator

Respiration Rate Waves Ratio (inspiration:expiration) Impedance variations ( ) Accuracy delta Baseline Accuracy baseline Respiration lead Apnea selection Power-on default Temperature Temperature Accuracy Compatibility Output Cardiac output Catheter type Calibration coeffecient Blood temperature Injectate volume Injectate temperature Cardiac output Faulty-injectate curve Left-to-right-shunt curve Calibrated pulse Connector Power-on default Baxter Edwards, 93a-131-7f 0.542 (0 C injectate), 0.595 (24 C injectate) 36 C (98.6 F) to 38 C (100.4 F) 0.2 C in 1 C steps 10 cc 0 C or 24 C 2.5, 5, 10 liters per minute 5 % Waveform for simulation available Waveform for simulation available 1.5 for 1 second Circular DIN 7 pin 5 liters per minute, 0 C injectate, 37 C blood temperature 3.0 C to 42.0 C in 0.5 C steps 0.4 C Yellow Springs, Inc. (YSI) Series 400 and 700 Circular DIN 4-Pin 0 (OFF), 15 BrPM to 150 BrPM in 1 BrPM steps Normal or ventilated Normal Ventilated (5 % of setting + 0.1 ) 500 , 1000 (default), 1500 , 2000 , Leads I, II, III 5% LA or LL (default) 12 sec, 22 sec, or 32 seconds (one-time events), or continuous (Apnea ON = respiration OFF) 20 BrPM, delta 1.0 1:1, 1:2, 1:3, 1:4, 1:5 1:1

0.00 to 1.00 in 0.05 steps and 1 to 5 in 0.25 steps

7 Fluke Biomedical

ProSim 8 Vital Signs Simulator

Non-invasive blood pressure Pressure units Manometer (pressure meter) mmHg or kPa Range Resolution Accuracy Pressure source NIBP simulations Target pressure range Resolution Pulse Volume of air moved Simulations (systolic/diastolic [MAP]) 10 mmHg to 400 mmHg 0.1 mmHg (0.5 % reading + 0.5 mmHg) 20 mmHg to 400 mmHg 1 mmHg 2 mmHg max into 500 ml NIBP system 1.25 ml max Adult: 60/30 (40), 80/50 (60); 100/65 (77); 120/80 (93); 150/100 (117); and 200/150 (167) and 255/195 (215) Neonatal: 35/15 (22); 60/30 (40); 80/50 (60); 100/65 (77); 120/80 (93) and 150/100 Pressure variability: systolic and diastolic pressures are variable by 1 mmHg NIBP simulations cont. Repeatability Within 2 mmHg (at maximum pulse size independent of device under test) Maximum rate at 1 ml: 240 BPM achievable with pulses up to 1 ml Maximum rate at 1.25 ml: 180 BPM Synchronization: arrhythmias Premature atrial contraction (PAC), premature ventricular contraction (PVC), atrial fibrillation, and missed beat 20 mmHg to 400 mmHg 0:30 min to 5:00 minutes: seconds in 30 second steps 0 mmHg/minute to 200 mmHg/ minute

Synchronization: normal Sinus heart rates: 30 BPM to 240 BPM

Leak test

Target pressure Elapse time Leakage rate

Pressure relief test range

100 to 400 mmHg

8 Fluke Biomedical

ProSim 8 Vital Signs Simulator

SpO2 simulations (optional) % O2 % O2 accuracy Range Resolution With oximeter manufacturers R-curve 30 % to 100 % 1% Saturation within UUT specific range: (1 count + specified accuracy of the UUT) Saturation outside UUT specific range: monotonic with unspecified accuracy With Fluke Biomedical R-curves 91 % to 100 % (3 counts + specified accuracy of the UUT) 81 % to 90 % (5 counts + specified accuracy of the UUT) 71 % to 80 % (7 counts + specified accuracy of the UUT) Below 71 % monotonic with unspecified accuracy Heart rate Transmission: ratio of detector current to LED current, expressed in parts per million (ppm) 30 BPM to 300 BPM in 1 BPM steps. SpO2 simulation is synchronized with ECG rate delayed by 150 ms. Range Resolution Accuracy 0 ppm to 300.00 ppm 0.01 ppm + 50 %/- 30 % for compatible monitors, unspecified for others. Selected by finger size and color: dark, thick finger, medium finger, light, thin finger, neonatal foot. 0 % to 20.00 % 0.01 % Range: 0 % to 5 % of transmission Resolution: 1 % Rate: all ProSim respiration simulation settings Ambient light Range: 0 to 5X transmitted light Resolution: 1X Frequency: DC, 50 Hz, 60 Hz, and 1 kHz to 10 kHz in 1 kHz steps Masimo Rainbow technology Simulate Masimo Rainbow technology with an optional adapter supplied by Masimo that allows the ProSim two wavelength simulation to test the Rainbow multiple wavelength system With manufacturer R-curve With Fluke R-curve Nellcor, Masimo, Nonin, and Nihon Kohden Mindray, GE-Ohmeda, Philips/HP, and BCI

Perfusion Artifact

Range Resolution Respiration

Compatible manufacturer products

9 Fluke Biomedical

ProSim 8 Vital Signs Simulator

Pre-Defined Simulations Normal Hypertensive Hypotensive Tachycardic Bradycardic Ventricular fibrillation Asystole Autosequences (default) Monitor testing sequence Medical training sequence Oximeter testing sequence Cardiac failure sequence Arrhythmia sequence Exercise sequence Respiration sequence Performance wave test IBP testing sequence Temperature sequence

10 Fluke Biomedical

ProSim 8 Vital Signs Simulator

Ordering information
ProSim 8 ProSim 8 Vital Signs Simulator ProSim SPOT ProSim SpO2 Test Module ProSim RAINBOW ProSim Rainbow Sensor

Models/descriptions

Standard accessories

3980671 ProSim 6/8 Users Manual 3980667 ProSim 6/8 Getting start manual 3938110 ProSim 6/8 Battery Pack 1626219 USB Cable 2392173 IBP Cable, unterminated 3987170 ProSim 6/8 Carrying Case 2392370 Adult Cuff Mandrel End Blocks 2392381 Adult Cuff Mandrel Spacer Blocks 2392328 Neonatal Cuff Mandrel 2391882 Set of NIBP Cuff Adapters 2184298 AC/DC Power Supply Power cord (country-specific)

Cable kits 3984910 ProSim 8 Accessory Kit (includes DIN to minDin adapter, HP/Philips Intellivue IBP cable, GE Marquette Eagle/Dash/Solar IBP cable, Welch Allyn Propaq/SpaceLabs Ultraview IBP cable, USB wireless dongle, YSI400 series temperature cable, YSI700 series temperature cable, CI-3 Cardiac Output Box, spare battery pack) 3984922 HP/Philips Intellivue Cable Set 3984968 GE Marquette Eagle/Dash/Solar Cable Set 3984946 ProSim 8 SpaceLabs Ultraview Cable set 3984979 Welch Allyn/Propaq Cable Set 3984993 Drager Infinity Cable Set 3985009 ProSim 8 Nihon Kohden Cable Set Blood pressure cables 2198879 BCI International TK-1 (6M) 2198879 Criticare Systems Inc. (1100) TK-1 (6M) 2198879 Critikon (Dinamap Plus) TK-1 (6M) 2198887 Datascope DS-1 (6F) 2200955 Datex (AS/3, CS/3, Compact, Cardio Cap II, Critical Care, Light) DX-1 (10F) 2199387 Fakuda Denshi (DS3300 series) FD-2 (12M) 2199682 GE Marquette Medical Corametrics (115, 116, 142, 145, 556) CM-3 (Nicolet round 12M) 2198893 GE Marquette Medical (PPG/E for M DR) EM-1 (6F) 2198978 GE Marquette Medical (7000 and TRAMAR series only) MQ-2 (8M round) 2199627 GE Marquette Medical (Dash, Eagle, Solar, Tram, and MacLab) MQ-3 (rectangular 11M) 2198902 Hewlett Packard/Philips (78-300, 78500, 78-800, Merlin/Viridia/ Omnicare (HP/Philips M1006B iBP module has a sensitivity of 5 uV/V/ mmHg only. The HP-3 cable should be selected for this application.) HP-3 (12M 5 V) 2198916 Hewlett Packard/Philips (78-300, 78500, 78-800, Merlin/Viridia/Omnicare) HP-4 (12M 40 V)

AC Power cords

2201437 ProSim 8 AC power cord Schuko 2201455 ProSim 8 AC power cord USA 2201428 ProSim 8 AC power cord UK 2201419 ProSim 8 AC power cord Japan 2201443 ProSim 8 AC power cord Australia 3930831 ProSim 8 AC power cord Brazil

Optional accessories

2392199 CI-3 Cardiac Output Box 3408564 Mini-DIN to DIN IBP Adapter 3890640 NIBP Test Chamber 500ML 4034627 Ansur Test Software ProSim 8 Plug-In

11 Fluke Biomedical

ProSim 8 Vital Signs Simulator

2199694 Hewlett Packard/Philips (8040A, M1350A) HP-8 (intrauterine pressure only 12M 40 V) 2198879 Invivo Research TK-1 (6M) 2198879 Ivy Biomedical (400 and 700 series) TK-1 (6M) 2198940 Medical Data Electronics (Escort series) PC-1 (6M) 2198933 Mennen Medical (Horizon series) MM-1 (6M) 2198879 North American Drager (Vitalert 2000) TK-1 (6M) 2198940 Physio Control (VSM series) PC-1(6M) 2198879 Protocol System (Propaq series) TK-1 (6M) 2190955 Puritan Bennett PB 240 DX-1 (10F) 2199176 Quinton (Q Cath series) QM-1 (6M) 2198925 Siemens (SIRECUST series) [SM1 and Siemens Medical Transducer Adapter (3368-383-E530U) used to run a single invasive BP channel on the Siemens Medical SC6000 and SC9000 series monitors] SM-1 (10M) 2199666 Siemens (Micor/Mingo) SM-3 (15M) 2198879 SpaceLabs (1050, 1700, PCMS series) (SpaceLabs adapters 700-0028-00 and 01200551-00 with TK-1 used when testing the new UltraView Command Module) TK-1 (6M)

2392173 Universal unterminated UU-1 (5-Pin DIN one end only) 2198893 Witt Biomedical EM-1 (6F) DIN PB IBP,Schiller PB Series IBP Cable (5M DIN) Temperature cables 2199019 UT-2 standard 1/4 in phone plug (compatible with YSI 700 series 3 conductor) 2199291 UT-3 unterminated cable (DIN plug on one end only) 2523334 UT-4 Low profile, 1/4 in phone plug, YSI 400 series compatible, two conductor 2199257 HPT-2 temperature adapter (Hewlett Packard) (2 pin, used with UT-1 for HP monitors) Cardiac output bath/injectate adapters 2392199 CI-3 cable assembly 2392158 General purpose connector 2199240 COA-1 Cardiac output adapter (Hewlett Packard) (HPT-2 also required for cardiac output simulation on HP patient-monitoring systems) 2199257 HPT-2 Temperature adapter (Hewlett Packard) (2 pin) (COA-1 also required for cardiac output simulation on HP patient-monitoring systems)

About Fluke Biomedical

Fluke Biomedical is the worlds leading manufacturer of quality biomedical test and simulation products. In addition, Fluke Biomedical provides the latest medical imaging and oncology quality-assurance solutions for regulatory compliance. Highly credentialed and equipped with a NVLAP Lab Code 200566-0 accredited laboratory, Fluke Biomedical also offers the best in quality and customer service for all your equipment calibration needs. Today, biomedical personnel must meet the increasing regulatory pressures, higher quality standards, and rapid technological growth, while performing their work faster and more efficiently than ever. Fluke Biomedical provides a diverse range of software and hardware tools to meet todays challenges.

Fluke Biomedical.
Better products. More choices. One company.
Fluke Biomedical 6045 Cochran Road Cleveland, OH 44139-3303 U.S.A. Fluke Biomedical Europe Science Park Eindhoven 5110 5692EC Son, The Netherlands For more information, contact us: In the U.S.A. (800) 850-4608 or Fax (440) 349-2307 In Europe/M-East/Africa +31 40 267 5435 or Fax +31 40 267 5436 From other countries +1 (440) 248-9300 or Fax +1 (440) 349-2307 Email: [email protected] Web access: www.flukebiomedical.com
2011 Fluke Biomedical. Specifications subject to change without notice. Printed in U.S.A. 4/2011 3983506C D-EN-N Modification of this document is not permitted without written permission from Fluke Corporation.

Fluke Biomedical Regulatory Commitment

As a medical test device manufacturer, we recognize and follow certain quality standards and certifications when developing our products. We are ISO 9001 and ISO 13485 medical device certified and our products are: CECertified,whererequired NISTTraceableandCalibrated UL,CSA,ETLCertified,whererequired NRCCompliant,whererequired

12 Fluke Biomedical

ProSim 8 Vital Signs Simulator