FLUKE ProSim 8 User Manual 3
FLUKE ProSim 8 User Manual 3
FLUKE ProSim 8 User Manual 3
PN 3984515
January 2011, Rev. 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.
Warranty and Product Support
Fluke Biomedical warrants this instrument against defects in materials and workmanship for one year from the date of
original purchase OR two years if at the end of your first year you send the instrument to a Fluke Biomedical service center
for calibration. You will be charged our customary fee for such calibration. 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
Fluke Biomedical. This warranty covers the original purchaser only and is not transferable. The warranty does not apply if the
product has been damaged by accident or misuse or has been serviced or modified by anyone other than an authorized
Fluke 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 DAMAGES OR LOSSES, INCLUDING LOSS OF DATA, ARISING FROM ANY CAUSE OR THEORY.
This warranty covers only serialized products and their accessory items that bear a distinct serial number tag. Recalibration
of instruments is not covered under the warranty.
This warranty gives you specific legal rights and you may also have other rights that vary in different jurisdictions. Since
some jurisdictions do not allow the exclusion or limitation of an implied warranty or of incidental or consequential damages,
this limitation of liability may not apply to you. If any provision of this warranty is held invalid or unenforceable by a court or
other decision-maker of competent jurisdiction, such holding will not affect the validity or enforceability of any other provision.
7/07
Notices
All Rights Reserved
Copyright 2016, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval
system, or translated into any language without the written permission of Fluke Biomedical.
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.
Technical Support
For application support or answers to technical questions, either email techservices@flukebiomedical.com or call 1-800- 850-4608 or
1-440-248-9300. In Europe, email techsupport.emea@flukebiomedical.com or call +31-40-2965314.
Claims
Our routine method of shipment is via common carrier, FOB origin. Upon delivery, if physical damage is found, retain all packing
materials in their original condition and contact the carrier immediately to file a claim. If the instrument is delivered in good physical
condition but does not operate within specifications, 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 (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When you
return an instrument to Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or Air Parcel Post. We also
recommend that you insure your shipment for its actual replacement cost. Fluke Biomedical will not be responsible for lost
shipments or instruments that are received in damaged condition due to improper packaging or handling.
Use the original carton and packaging material for shipment. If they are not available, we recommend the following guide for
repackaging:
Use a double–walled carton of sufficient strength for the weight being shipped.
Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material around all projecting parts.
Use at least four inches of tightly packed, industry-approved, shock-absorbent material around the instrument.
Returns for partial refund/credit:
Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from our
Order Entry Group at 1-440-498-2560.
Repair and calibration:
To find the nearest service center, go to www.flukebiomedical.com/service or
In the U.S.A. and Asia: In Europe, Middle East, and Africa:
Cleveland Calibration Lab Eindhoven Calibration Lab
Tel: 1-800-850-4608 x2564 Tel: +31-40-2675300
Email: globalcal@flukebiomedical.com Email: ServiceDesk@fluke.com
To ensure the accuracy of the Product is maintained at a high level, Fluke Biomedical recommends the product be calibrated at least
once every 12 months. Calibration must be done by qualified personnel. Contact your local Fluke Biomedical representative for
calibration.
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.
Manufacturing Location
The ProSim™ 8 Vital Signs Simulator is manufactured at Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A.
Introduction The intended user is a trained biomedical equipment
technician who performs periodic preventative
The Fluke Biomedical ProSim™ 8 Vital Signs Simulator
maintenance checks on patient monitors in service. Users
(hereafter the Product) is a full-featured, compact,
can be associated with hospitals, clinics, original
portable simulator, used to measure the performance of
equipment manufacturers and independent service
patient monitors.
companies that repair and service medical equipment.
Intended Use The end user is an individual, trained in medical
instrumentation technology.
The Product is intended to be used to test and verify the
basic operation of patient monitoring devices or systems This Product is intended to be used in the laboratory
used to monitor various physiological parameters of a environment, outside of the patient care area, and is not
patient, including ECG, Respiration, Invasive blood intended for use on patients, or to test devices while
pressure, Non-invasive blood pressure, Temperature, and connected to patients. This Product is not intended to be
Cardiac output. Additionally, the Devices provide an used to calibrate medical equipment. It is intended for
optical signal to verify that the electronics within the pulse over the counter use.
oximeter probe are functional.
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Vital Signs Simulator
Safety Information
• Remove all probes, test leads, and • Replace the mains power cord if the
accessories before the battery door is insulation is damaged or if the insulation
opened. shows signs of wear.
• The battery door must be closed and • Use only the external mains power supply
locked before you operate the Product. included with the Product.
• Replace the batteries when the low battery • Connect the battery charger to the mains
indicator shows to prevent incorrect power outlet before the Product.
measurements.
• Do not put metal objects into connectors.
• Remove the batteries if the Product is not
used for an extended period of time, or if • Do not connect the Product to a patient or
stored in temperatures above 50 °C. If the equipment connected to a patient. The
batteries are not removed, battery leakage Product is intended for equipment
can damage the Product. evaluation only and should never be used
in diagnostics, treatment, or any other
• Use only the mains power cord and capacity where the Product would come in
connector approved for the voltage and contact with a patient.
plug configuration in your country and
rated for the Product.
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• Batteries contain hazardous chemicals that • Remove the input signals before you clean
can cause burns or explode. If exposure to the Product.
chemicals occurs, clean with water and get
medical aid. • Use only specified replacement parts.
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Vital Signs Simulator
Symbols
Symbols
Table 1 describes symbols used in association with the Product.
Table 1. Symbols
Symbol Description Symbol Description
Conforms to relevant Australian EMC Complies with 47 CFR Part 15 requirements of the U.S.
standards. Federal Communications Commission.
This product complies with the WEEE Directive marking requirements. The affixed label indicates that you must
not discard this electrical/electronic product in domestic household waste. Product Category: With reference to
~ the equipment types in the WEEE Directive Annex I, this product is classed as category 9 "Monitoring and
Control Instrumentation" product. Do not dispose of this product as unsorted municipal waste.
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Instrument Familiarization
Table 2 is a list of Product top-panel controls and connections shown in Figure 1.
Top
1
2
3
18
4
17
5
16
6
15
F1 F2 F3 F4 F5
7
14
12
13 11 10 9 8
glh034.eps
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Vital Signs Simulator
Instrument Familiarization
ECG Posts Connection posts for Device Under Test (DUT) ECG leads.
Accesses the ECG waveforms (adult, pediatric, and arrhythmias), and ECG test functions
ECG Function
(performance waves, QRS detection, Tall T wave rejection, and R wave detection).
Accesses the temperature, respiration, cardiac output, fetal simulation, autosequences, and
Special Functions
view memory functions.
Navigation Buttons Cursor control buttons for navigating menus and lists.
Keys F1 through F5 are used to select from a number of selections that appear in the LCD
Function Softkeys
display above each function softkey.
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Cardiac Output Connector Connector to the Cardiac input of the patient monitor.
IBP Channel 1 Connector Connector to the IBP input of the patient monitor.
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Vital Signs Simulator
Instrument Familiarization
Back
1
2 3 4 5 6
Front Right
7 8
glh035.eps
Figure 2. Back, Front, and Side Panel Connections
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AC/DC Supply Connector Input jack for the DC output of the AC/DC supply connector.
Battery Charge LED Battery charges 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 for remote control or download test results data to a PC.
Air Port Connector Pressure port for NIBP cuff and monitor.
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Vital Signs Simulator
How to Turn the Product On
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Vital Signs Simulator
Detailed Specifications
USA (FCC) .......................................................... 47 CFR 15 Intentional Radiators: This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference.
(2) This device must accept any interference received, including interference that may cause undesired operation. (15.19).
Changes or modifications not expressly approved by Fluke could void the user's authority to operate the equipment. (15.21)
Detailed Specifications
Normal-Sinus-Rhythm Waveform
ECG Reference ...................................................... The ECG amplitudes specified are for Lead II (calibration), from the baseline to the peak
of the R wave. All other leads are proportional.
Normal Sinus Rhythm ........................................... 12-lead configuration with independent outputs referenced to right leg (RL). Output to
10 Universal ECG Jacks, color-coded to AHA and IEC Standards.
High-Level Output ................................................. 0.5 V/mV ±5 % of the ECG amplitude setting available on a BNC connector.
Amplitude ............................................................... 0.05 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 ............................................................... 100
Lead V4 ............................................................... 120
Lead V5 ............................................................... 112
Lead V6 ............................................................... 80
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Vital Signs Simulator
Detailed Specifications
Arrhythmia
Baseline NSR ......................................................... 80 BPM
PVC Focus ............................................................. Left focus, standard timing (except where specified)
Supraventricular Arrhythmia................................ Atrial fibrillation (coarse or fine); atrial flutter; sinus arrhythmia; missed beat (one time);
atrial tachycardia; paroxysmal atrial tachycardia; nodal rhythm; and supraventricular
tachycardia.
Premature Arrhythmia .......................................... 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
Ventricular Arrhythmia ......................................... PVCs 6 per minute, 12 per minute, or 24 per minute; frequent multifocal PVCs; bigeminy;
trigeminy; multiple PVCs (one-time run of 2 PVCs, 5 PVCs, or 11 PVCs); mono-
ventricular tachycardia (120 BPM to 300 BPM in 5 BPM steps); poly-ventricular
tachycardia (5 types); ventricular fibrillation (coarse or fine); and Asystole
Conduction Defect ................................................ First-, second-, or third-degree heart block; and right- or left-bundle-branch block
Advanced Cardiac Life Support
Shockable Pulseless Arrest Rhythms ................. Ventricular fibrillation (coarse), ventricular fibrillation (fine), unstable polymorphic
ventricular tachycardia
Non Shockable Pulseless Arrest Rhythms .......... Asystole
Symptomatic Bradycardia ................................... Sinus Bradycardia (<60 BPM)
nd
2 Degree AV Block, Mobitz Type I
nd
2 Degree AV Block, Mobitz Type II
rd
Complete/3 Degree AV Block
Right Bundle Branch Block
Left Bundle Branch Block
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Symptomatic Tachycardia
Regular Narrow-complex Tachycardias (QRS <0.12 seconds)
Sinus Tachycardia ...................................... >150 BPM
Supraventircular Tachycardia ..................... SVT
Regular Wide-complex Tachycardias (QRS ≥0.12 seconds)
Sinus Tachycardia ...................................... >150 BPM
Supraventircular Tachycardia ..................... SVT with aberrancy
Irregular Tachycardia ...................................... 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)
ECG-Performance-Testing
Amplitude (peak-to-peak) ..................................... 0.05 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 through V6 ............................................ 100
Pulse Wave ............................................................ 30 BPM, 60 BPM, with 60 ms pulse width
Square Wave ......................................................... 0.125 Hz, 2.0 Hz, 2.5 Hz
Triangle Wave ........................................................ 0.125 Hz, 2.0 Hz, 2.5 Hz
Sine Wave .............................................................. 0.05 Hz, 0.5 Hz, 1 Hz, 2 Hz, 5 Hz, 10 Hz, 25 Hz, 30 Hz, 40 Hz, 50 Hz, 60 Hz, 100 Hz, and
150 Hz
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Vital Signs Simulator
Detailed Specifications
R-wave Detection
Waveform ............................................................ Triangular pulse
Rate ..................................................................... 30 BPM, 60 BPM, 80 BPM, 120 BPM, 200 BPM, and 250 BPM
Width ................................................................... 8 ms to 20 ms in 2 ms steps, and 20 ms to 200 ms in 10 ms steps
Width Accuracy ................................................... ±(1 % of setting + 1 ms)
QRS Detection
Widths ................................................................. 8 ms to 20 ms in 2 ms steps and 20 ms to 200 ms in 10 ms steps
Width Accuracy ................................................... ±(1 % of setting + 1 ms)
Rate ..................................................................... 30 BPM, 60 BPM, 80 BPM, 120 BPM, 200 BPM, and 250 BPM
R-Wave up slope ................................................. 0.875 amplitude, 0.4375 x width
R-Wave down slope ............................................ Full amplitude, 0.5 x width
S-Wave up slope ................................................. 0.125 amplitude, 0.0625 x width
Tall T-Wave Rejection
Waveform
QT Interval ...................................................... 350 ms
T-Wave width .................................................. 180 ms
T-Wave Shape ................................................ ½ sinewave
Amplitude ............................................................ 0 % to 150 % reference lead amplitude in 10 % steps
Rate ..................................................................... 80 BPM
Rate Accuracy ....................................................... ±1 % of setting
Amplitude Accuracy.............................................. ±(2 % of setting + 0.05 mV)
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ECG Artifact
Type ........................................................................ 50 Hz, 60 Hz, muscular, baseline wander, 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 Rate (IUP) ........................................... 140 BPM at beginning, then varies with pressure
Intrauterine-Pressure Waveforms ....................... Early deceleration, late deceleration, and acceleration
Wave Duration ....................................................... 90 seconds, bell-shaped pressure curve, from 0 mmHg to 90 mmHg and returning to
0 mmHg
IUP Period .............................................................. 2 minutes, 3 minutes, or 5 minutes; and manual
Default Settings ..................................................... FHR 140 BPM, early deceleration wave, manual
Invasive Blood Pressure
Channels ................................................................ 2, each independently settable with identical parameters and are individually electrically
isolated from all other signals
Input/output Impedance ....................................... 300 Ω ±10 %
Exciter Input Range .............................................. 2.0 V to 16.0 V peak
Exciter-Input Frequency Range ........................... DC to 5000 Hz
Transducer Sensitivity ......................................... 5 μV/V/mmHg (default) or 40 μV/V/mmHg
Pressure Accuracy ............................................... ±(1 % of setting + 1 mmHg) Accuracy guaranteed for DC excitation only
Static Pressure ...................................................... -10 mmHg to +300 mmHg in 1 mmHg steps
Pressure Units ....................................................... mmHg or Kpa
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Vital Signs Simulator
Detailed Specifications
Dynamic Waveforms
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.
Swan-Ganz Sequence ........................................... Right atrium, right ventrical (RV), pulmonary artery (PA), pulmonary artery wedge (PAW)
Cardiac Catheterization
Chambers ............................................................ Aortic, Pulmonary valve, and Mitral valve
Respiration Artifact
Arterial, radial artery, and left ventricle ................ 5 % to 10 % multiplication
Other ................................................................... 5 mmHg or 10 mmHg
BP Output............................................................... Circular DIN 5-Pin
Power-On Default .................................................. 0 mmHg
Respiration
Rate......................................................................... 0 BrPM (OFF), 10 BrPM to 150 BrPM in 1 BrPM steps
Waves ..................................................................... Normal or ventilated
Ratio (inspiration:expiration)
Normal ................................................................. 1:1, 1:2, 1:3, 1:4, 1:5
Ventilated ............................................................ 1:1
Impedance Variations (Δ Ω) .................................. 0.00 Ω to 1.00 Ω in 0.05 Ω steps and 1.00 Ω to 5.00 Ω in 0.25 Ω steps
Delta Accuracy ...................................................... ±(5 % of setting + 0.1 Ω)
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Baseline ................................................................. 500 Ω, 1000 Ω (default), 1500 Ω, 2000 Ω, Leads I, II, III
Baseline Accuracy ................................................ ±5 %
Respiration Lead ................................................... LA or LL (default)
Apnea Selection .................................................... 12 seconds, 22 seconds, or 32 seconds (one-time events), or continuous (Apnea ON =
respiration OFF)
Power-On Default .................................................. 20 BrPM, delta 1.0 Ω
Temperature
Temperature .......................................................... 30.0 °C to 42.0 °C in 0.5 °C steps
Accuracy ................................................................ ±0.4 °C
Compatibility ......................................................... Yellow Springs, Inc. (YSI) Series 400 and 700
Output .................................................................... Circular DIN 4-pin
Cardiac Output
Catheter Type ........................................................ Baxter Edwards, 93a-131-7f
Calibration Coefficient .......................................... 0.542 (0 °C injectate), 0.595 (24 °C injectate)
Blood Temperature ............................................... 36 °C (98.6 °F) to 38 °C (100.4 °F) ±0.2 °C in 1 °C steps
Injectate Volume ................................................... 10 cc
Injectate Temperature ........................................... 0 °C or 24 °C
Cardiac Output ...................................................... 2.5 liters per minute, 5 liters per minute, 10 liters per minute ±7.5 %
Faulty-Injectate Curve .......................................... Waveform for simulation available
Left-to-Right-Shunt Curve .................................... Waveform for simulation available
Calibrated Pulse .................................................... 1.5 °C for 1 second
Connector .............................................................. Circular DIN 7 pin
Power-On Default ................................................. 5 liters per minute, 0 °C injectate, 37 °C blood temperature
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Vital Signs Simulator
Detailed Specifications
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ProSim™ 8
Getting Started Manual
Leak Test
Target Pressure .................................................. 20 mmHg to 400 mmHg
Elapsed time ....................................................... 0:30 minutes:seconds to 5:00 minutes:seconds in 30 second steps
Range ................................................................. 0 mmHg/minute to 200 mmHg/minute
Internal Leak rate .................................................... <2 mmHg/min into 500 ml rigid volume
Pressure Relief Test Range ................................. 100 mmHg to 400 mmHg
Oximeter SpO2 Optical Emitter and Detector (optional)
% O2
Range ................................................................. 30 % to 100 %
Resolution ........................................................... 1 %
Accuracy
With oximeter manufacturer’s R-curve
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
Range ................................................................. 30 BPM to 300 BPM in 1 BPM steps. Oximeter SpO2 Optical Emitter and Detector is
synchronized with ECG rate delayed by 150 ms.
Accuracy ............................................................. ±1 % of setting
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Vital Signs Simulator
Detailed Specifications
Transmission (Ratio of detector current to LED current, expressed in parts per million (ppm))
Range .................................................................. 0 ppm to 300.00 ppm
Resolution ........................................................... 0.01 ppm
Accuracy.............................................................. +50 %/-30 % for compatible monitors, unspecified for others. Selected by finger size and
color: Dark, thick finger, medium finger, light, thin finger, neonatal foot.
Pulse Amplitude
Range .................................................................. 0 % to 20.00 %
Resolution ........................................................... 0.01 %
Artifact
Respiration
Range .............................................................. 0 % to 5 % of transmission
Resolution ....................................................... 1 %
Rate ................................................................. all ProSim respiration simulation settings
Ambient Light
Range .............................................................. 0X 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 .............................. Masimo Rainbow technology with an optional adapter supplied by Masimo that allows the
ProSim two wavelength to test the Rainbow multiple wavelength system
Compatible Manufacturer Products
With manufacturer R-curve ................................. Nellcor, Masimo, Nonin, and Nihon Kohden
With Fluke Biomedical R-curve ........................... Mindray, GE-Ohmeda, Philips/HP, and BCI
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ProSim™ 8
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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
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