Pulse
Duplicator

ViVitest Data Acquisition System (DAS)

Product Code: 08530, Related Part Numbers: 08311 I/O Module, AP9991 AmPack

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 pulsatile pump 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 pulsatile pump while the data acquisition system captures and analyzes physiological pressures and valve flow rates. Data Acquisition

• Flow and pressure readings can be collected and analyzed in real time meeting ISO 5840-2:2015, ISO 5840-3:2013 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: 08530 Data Acquisition System

PN 08311 I/O Module and AP9991 AmPack

QCtest Software

Product Code: 26066

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 Production 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

 

Viscoelastic Impedance Adapter (VIA)

Product Code: VIA7991

The ViVitro Viscoelastic Impedance Adapter (VIA) works in conjunction with the SuperPump pulsatile pump to produce more realistic physiological ventricular pressures. It consists of a fixed resistive element and two adjustable compliance chambers to simulate ventricular viscoelastic behavior.

Features:

• Adjustable dP/dt ratio to produce both physiological and diseased cardiac models
• Filters high frequency noise when testing prosthetic valves and aortic conduits
• Easily adjusted

 

Reference Valves

Product Code: 56466 - REFERENCE VALVE ASSEMBLY, SJM MECHANICAL, 19MM

Product Code: 56468 - REFERENCE VALVE ASSEMBLY, SJM MECHANICAL, 25MM

ISO 5840-2:2021 and 5840-3:2021 now require reference valves to help characterize pulse duplicator system performance. ViVitro Labs offers the valve specified in the standard, mounted in a holder compatible with ViVitro equipment.

Features:

• A certificate documenting all the operating conditions required to properly test the valve in accordance with ISO 5840:2021.
• A certificate showing valve meets ISO 5840:2021 acceptance criteria.

Large Atrium Chamber (Mitral)

Product Code: 21179

The Large Atrium chamber allows devices with an outer diameter of up to 70mm 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



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 34 French deployment devices and mounts easily to a ViVitro Model Heart (Left or Right). 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

The ViVitro Aortic Conduit Mount (formerly LVOT) can be used to mount a compliant aorta and test percutaneous valves in the ViVitro Model Heart (Left or Right) 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. The aortic conduit mount accommodates conduit lengths from 44 to 64 mm.

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

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

Aortic Particle Image Velocimetry (PIV) Flow Visualization

The PIV Load Assembly provides an optically clear, anatomically representative aortic inflow and outflow to enable Particle Imaging Velocimetry studies in the Pulse Duplicator. The PIV Load Assembly replaces the lower half of the standard aortic load assembly and is easily substituted into the ViVitro Labs Pulse Duplicator.  

• Optically clear, non-distorting inflow and outflow section
• Interchangeable and customizable silicone aortic annulus
• Anatomical aortic sinuses
• Outflow pressure port
• Easily installed in the Pulse Duplicator

Specifications

The geometry of the aortic root is based on a reasonable simplification of the average measurements published in manuscripts by Tops (2008) and Buellesfeld (2013) (data procured from MSCT).  

• Optically clear Acrylic components
• 28mm I.D. aortic root (other sizes available upon request)
• 90mm long outflow section
• 38mm inflow section

PIV setup including laser, lenses, high speed camera, and PIV Load Assembly in a Pulse Duplicator.

The ViVitro Production Tester Quality Control System 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 Production Tester quickly captures reliable results for a fraction of the cost of designing an in-house system. In conjunction with QCtest software, the Production 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
• 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

 

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).

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

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

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

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

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