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Pulse Duplicator

The ViVitro Pulse Duplicator system is the world’s most widely cited and most used in-vitro cardiovascular hydrodynamic testing system.

The ViVitro Pulse Duplicator simulates the function of the heart (left or right) by generating pulsatile flow through prosthetic heart valves placed in the Model Left Heart. Powered by the ViVitro SuperPump, it is composed of the ViVitro Model Left Heart, SuperPump, Flow Measuring System and ViViTest data acquisition system. The components work together to assess the performance of prosthetic heart valves under simulated cardiac conditions.. The ViVitro Pulse Duplicator System is used by the US Food and Drug Administration and is recognised by regulatory bodies worldwide including TÜV, BSI and the Chinese SFDA.

The Pulse Duplicator System assesses the performance of cardiovascular devices and prosthetic heart valves under simulated cardiac conditions. It simulates physiological or other complex flow variations while allowing the user to vary the peripheral resistance and compliance of the system. Pressure ports and flow measuring locations allow for data to be collected from aortic or mitral sites. Transparent viewpoints allow multiple viewing angles of the valve including inflow and outflow.

Combined with the ViVitest software control system, it quickly, easily and reliably collects and analyzes physiological flow and pressure data. The ViVitest software also allows the user to
easily modify and customize waveforms.

The ViVitro Pulse Duplicator System is cited in numerous studies throughout the world.   Visit our Citation Database for the current list of applications and articles.

Read our FAQ: 10 ways ViVitro Pulse Duplicator compares to equipment built in-house.

Contact Us for a more comprehensive understanding of how the ViVitro Pulse Duplicator can be customized to expand and enhance your device testing capabilities.

 

Product Code: PD2010
Related Part Numbers: SD2001 Model Left Heart, FS0992 Flow Meter
  • Capable of testing a range of prosthetic heart valves including stented tissue, percutaneous, stentless, mechanical, and other valves
  • Flow and pressure readings can be acquired meeting ISO 5840 frequency response and accuracy requirements and analyzed for device performance to ISO 5840 requirements
  • Peripheral resistance and supplementary characteristic compliances to simulate cardiovascular character and resistance
  • Evaluate LVAD or other assist devices (with customization)
  • Test structural heart and peripheral vascular devices
  • Flow and pressure readings can be collected and analyzed in real-time, meeting ISO 5840 requirements
  • Controls pulsatile fluid flows to simulate various cardiac flow conditions including arrhythmia, normal, hypo and hypertensive states at an assortment of cardiac outputs and beat rates
  • Transducer sites allow measurement of wall pressures in the atrium, ventricle, and aortic outflow tract
  • Flow can be measured directly at the aortic or mitral sites
  • Simulates cardiovascular peripheral resistance and compliance
  • Thin acrylic windows permit echo imaging, Doppler flow measurements, and PIV for interrogation of flow field regions
  • Allows hydrodynamic testing of heart valve replacements in order to assess mechanical and hemodynamic performance
  • Ventricle membrane to replicate the natural chamber flow
  • For testing other implantable cardiac devices including Occluder and Closure Devices, customizations, optional components, and accessories are available
Testing Capabilities and Applications

• Transcatheter valves (Aortic or Mitral) • Surgical valves (Mechanical and Biological) • Stentless valves • Structural heart and peripheral vascular devices • Occluder and Closure Devices (with customization) • Evaluate LVAD or other assist devices (with customization)

Pump & MLH
53 x 92 x 45 cm
DAS & Flow System
48 x 33 x 32 cm
Dry weight: Actuator +
Model Left Heart + VIA
18 kg
Dry weight:
Flow Measuring System
5.6 kg
Operating Voltage
90-240 VAC / 50-60Hz
Temperature range
Ambient to 40°C ± 1.0°C
Flow rate
0 - 15 L/min
Heart rate
3 - 200 bpm
Valve size Aortic
Up to 035mm
Valve size Mitral
Up to 035mm (*055mm with Large Atrium Accessory)
Pulse Duplicator image  

Model Left Heart System Components

Product Code: SD2001 Model Left Heart
The ViVitro Model Left Heart emulates the pressures and flows of the left heart allowing insertion of valves and other devices into the Pulse Duplicator system for testing. It includes transparent elements to visualize valve function and adjacent flow fields. Ports are available for transducers to measure wall pressures in the left atrium, left ventricle, aortic outflow tract, and downstream of the aortic valve. Left Heart Model ViVitro-Brochure-Download-button

Large Atrium Chamber (Mitral)

Product Code: 21179
The Large Atrium chamber allows devices with an outer diameter of up to 55mm to be tested in the Pulse Duplicator. • Expands the mitral device testing capabilities of the system • Quick-release system allows fast device changes • Accurate flow measurements from flow probe at Atrium inflow • Enhanced visibility using large viewing window for mitral device inflow • Customizable Valve Mounting • Easily added to a ViVitro Pulse Duplicator Large Atrium Chamber.png ViVitro-Brochure-Download-button

ViVitest Data Acquisition System (DAS)

Product Code: PDA2010

ViVitest is part of the ViVitro Data Acquisition System (DAS) family of software products. Combined with the Pulse Duplicator System it collects hydrodynamic testing data to meet ISO 5840 requirements. ViVitest software controls the SuperPump while simultaneously measuring pressure and flow data. It monitors, processes, and reports data such as regurgitant fraction, effective orifice area (EOA), and other valve performance indicators.

A calibration wizard walks new users through the set-up process for quick system preparation for testing. Output files are available in .CSV format for easy analysis in Excel and MatLab.

The ViViTest control system inputs a waveform to the SuperPump while the data acquisition system captures and analyzes physiological pressures and valve flow rates. ViVitest DAS Data Acquisition
  • Flow and pressure readings can be collected and analyzed in real time meeting ISO 5840-2, ISO 5840-3 and FDA requirements
  • Calibration wizards walk new users through the set up process, facilitating a wide array of data collection options.
  • Collects pressure and flow data for complete hydrodynamic performance.
  • Provides output files in versatile formats for easy analysis in Excel and MatLab
Waveform Control
  • Ability to create and control cardiac waveforms at various physiological states and frequencies, including arrhythmia and wave trains
  • Waveforms can be easily created with up to 1200 control statements
Product Code: PDA2010 Data Acquisition System
PN 08311 I/O Module and AP9991 AmPack
  • Backwards compatible with ViVitro products
  • .Net 3 Platform
  • Configured for 64-bit Windows 7 operating systems
  • Installer allows for easy updates
  • Singular program eliminates the need for intrusive third party software
Easy-to-read interface

Easy-to-read interface

ViVitro-Brochure-Download-button
 

QCtest Software

Product Code: QCtest

ViVitro QCtest checks valve performance against user defined acceptance criteria. It is a turn-key, validated function test software system. The software is easy to use and can be paired with a specific Function Tester Load Assembly on the ViVitro Pulse Duplicator, for quick valve change-outs. This combination is a ready-to use solution for one of the most time-consuming aspects of production to validate.

The QCtest software system was developed as a quality control tool for QC performance testing (function testing) of cardiovascular devices such as heart valves. This production tool provides fast, reliable results at a fraction of the cost of designing and validating an in-house system. Features:
  • Pass or fail criteria definable using a secure log-in
  • Automatically saves pass/fail results along with a report of each test and video
  • User definable system calibration intervals
  • Simple user interface
 
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Aortic Conduit Mount (formerly LVOT)

Product Code: 18903

The ViVitro Aortic Conduit Mount (formerly LVOT) can be used to mount a compliant aorta and test percutaneous valves in the ViVitro Model Left Heart system. A variety of Aortic Conduit Mount sizes can be custom made to accommodate silicone tubes with relaxed tube IDs of 12-29 mm. A tube may be expandable up to about 50mm OD.

Available in the following sizes: 12, 14, 16, 18, 20, 22, 24, 26, 28, and 29 mm ID.

Inflator Syringe

Product Code: 26365

The Inflator Syringe includes a plunger lock and fine threaded adjustment for easier pressure calibration of the ViVitro Data Acquisition System.

• 25 mL barrel volume • Locking plunger • Fine adjustment by means of the threaded plunger knob

Pressure Transducers

Product Code: HCM018

The ViVitro Data Acquisition System includes 3 Utah Medical 6069 Pressure Transducers. Additional Pressure Transducers can be ordered separately.

A cable test-port allows for easy verification of monitoring system accuracy and reusable interface cables are available for most every monitor.
  • The I/O Module and AmPack provide the interface from the pressure transducers to the Data Acquisition System.
  • Suitable for use with the Pulse Duplicator, EV Simulator, Real-Time Wear Tester or the HiCycle (modified connector when used with Scan Valve).

Heat Exchanger and Heat Bath

Heat Exchanger Product Code: HE9991, Heat Bath Product Code: 10679 N.A., 10680 Int'l

The ViVitro Heat Exchanger allows heating of test fluid with minimal interference of the fluid flow.

  • An isolated inflow and outflow metal heat conducting channel transfers heat to the solution
  • Maintains testing solution to desired temperature ± 0.5°C
ViVitro-Brochure-Download-button

The Heat Bath Temperature Controller delivers rapid fluid heat-up, optimized for the ViVitro Pulse Duplicator. These heated circulating baths feature a long life, high-wattage heater.

  • Over Temperature and Low Reservoir level automatic system cut-offs eliminate risk of over heating system components
Reservoir volume
6 litres (1.5 gallons)
Temperature range
ambient 15°C to 150°C
Stability
Digital ±0.05°C
Work area dimensions
20 x 15 x 13 cm
Overall dimensions
23 x 36 x 37 cm
Heater
1000 W
Pumping capacity
12 L/min at 0 psig
Electrical Requirements
115 VAC, 60 Hz, 15 amp or 230 VAC, 50 Hz 10 amps (specify when ordering)

Digital Thermometer

Product Code: 24086

A digital thermometer allows easy fluid temperature measurement in the Pulse Duplicator.

  • Traceable to standards provided by NIST
  • Accuracy/Resolution: 0.1° from -20 to +100°C
Digital Thermometer Product Code: 24086

Left Ventricular Assist Device (LVAD) Accessory

Product Code: 25205

The Left Ventricular Assist Device (LVAD) accessory enables testing of LVAD devices with physiological pulsatile flows generated by the ViVitro Pulse Duplicator. It is an optional add-on to the ViVitro Pulse Duplicator.

The Left Ventricular Assist Device (LVAD) accessory enables testing of LVAD devices with physiological pulsatile flows generated by the ViVitro Pulse Duplicator. It is an optional add-on to the ViVitro Pulse Duplicator. A ventricular cannulation option is also available. Connection points are ½” hose barbs. The accessory package includes components which provide connection points for the:
  • Ventricle apex
  • Aortic chamber
IMG_3245
IMG_3243 ViVitro-Brochure-Download-button

Percutaneous Access Device

Transapical Access Product Code: 18496
Transfemoral Access Product Code: 18497

ViVitro offers two standard methods of deploying percutaneous devices into the Pulse Duplicator system; either Transfemoral or Transapical access (Aortic and Mitral). Additional methods can be customized by ViVitro or third party specialists.

Percutaneous Catheter Access enables the deployment of transcatheter devices in an active Pulse Duplicator while the flow loop is operating under pressure. The Percutaneous Catheter Access is designed to accommodate up to 26 French deployment devices and mounts easily to a ViVitro Model Left Heart. Features:
  • Transapical access can be rotated to access aortic or mitral valves
  • Catheter insertion with little to no fluid loss during pulsatile operation
  • Replaceable valves
  • Easy to disassemble and clean

Digital Manometer

Product Code: 6104

This precision, handheld, digital pressure reference manometer  conveniently calibrates pressure transducers. Can be re-calibrated in the field for zero, span, and linearity.

  • Accurate primary standards to calibrate devices locally
  • 1 point or 5 point calibration options
  • Engineering Units - Inches of H2O (select 4 °C, 20 °C, or 60 °F), PSI, mm of Hg, inches of Hg, mBars, Bars, kPa, kg/cm2, cm of H2O and user selectable scaling.
  • Accuracy: ±0.05% FS
  • Media Compatibility - DN: Non-isolated differential sensor for clean, dry, non-corrosive gases. GI & AI: Isolated Gauge or Absolute sensor for fluids compatible with 316L SS
manometer
ViVitro-Brochure-Download-button

Function Tester

Product Codes: QCtest, 18652, and 18407

The ViVitro Function Tester provides a simplified system that assesses valve performance criteria for production quality control. It is an add-on to the ViVitro Pulse Duplicator and is intended for Production / QC applications.

The Function Tester quickly captures reliable results for a fraction of the cost of designing an in-house system. In conjunction with QCtest software, the Function Tester assesses pressure and flow criteria while recording high speed valve footage via an integrated camera. Features & Applications
  • Captures pressure and flow data including:
    • Transvalvular Pressure
    • Effective Orifice Area
    • Regurgitant Fraction
  • Captures high-speed video with integrated camera
  • Provides Pass/Fail results
  • Administrators can set individual operation parameters for technicians:
    • Operating conditions
    • User defined Pass/Fail performance assessment
    • Defined calibration expiry intervals
  • Test data is tracked by linking result logs to valve model and serial number
  • Quick-change valve holder can be custom-tailored to valve design
  • Customizable quick-change valve holder
 
GDZ Function Tester B 1256           ViVitro-Brochure-Download-button

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