testing products & laboratory services catalog · dynamic failure mode: potential failure modes...
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TESTING PRODUCTS & LABORATORY SERVICES CATALOG
CONTENTSAbout ViVitro
History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Lab TestingCertification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3Cardiovascular Device Testing . . . . . . . . . . . . . . . . . . .3Lab Services Customer Feedback . . . . . . . . . . . . . . . .4Customized Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . .5Hydrodynamic Testing . . . . . . . . . . . . . . . . . . . . . . . . . .6Durability Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7Ex-Vivo Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Endovascular Testing . . . . . . . . . . . . . . . . . . . . . . . . . . .8
ProductsSuperPump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9ViVigen + ViVitest Software . . . . . . . . . . . . . . . . . . . . .11Pulse Duplicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Left Heart Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16Large Atrium Chamber (Mitral) . . . . . . . . . . . . . . . . .16ViVitest Data Acquisition System (DAS) . . . . . . . . . . .17 Family of Testing Products and Services for Heart Valves and other Cardiovascular Devices . . . .23 Endovascular Simulator . . . . . . . . . . . . . . . . . . . . . . .25Real-Time Wear Tester (RWT) . . . . . . . . . . . . . . . . . . .27HiCycle Durability Tester . . . . . . . . . . . . . . . . . . . . . . .29Mitral HiCycle Durability Tester . . . . . . . . . . . . . . . . .31Hitest Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Customer Support ServicesTechnical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . .35Warranties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36Dialogues with Today’s Cardiovascular Pioneers . . .37
Contact UsContact Us . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
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HISTORYDavid Walker, Ph.D. and Larry Scotten, Dipl. T.
founded ViVitro Systems to evaluate a heart valve
developed at the Royal Jubilee Hospital’s Cardiac
Development Lab in Victoria, BC, Canada. David
and Larry’s prototype (built using a VW piston) was
able to simulate valve positioning and physiological
compliances accurately and repeatedly.
In 2009, ViVitro Systems assets were acquired
by StarFish Group and renamed ViVitro Labs.
StarFish Group is a Victoria BC-based company that includes StarFish Medical, a medical device
design development and manufacturing firm. Their co-located relationship enables ViVitro to leverage
extensive medical device development expertise and quality systems.
ViVitro hardware and software products are used by leading R&D facilities, academic labs, and
regulatory bodies worldwide. Our equipment and testing methods are cited in hundreds of peer
reviewed publications. Visit our website for links to all cited publications broken down by product
and application. www.vivitrolabs.com/cited-publications
David Walker and Larry Scotten demonstrate CDL Valve Research.
ViVitro-based systems are used in over 40 countries worldwide.
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LAB TESTINGCertificationSave time and build regulatory confidence with independent
lab results from ViVitro Labs. Our laboratory testing services
are accredited by the American Association for Laboratory
Accreditation (A2LA) and are based on ISO 5840. ViVitro
Labs Inc. holds ISO/IEC 17025:2005 accreditation for:
Cardiovascular Implants – Cardiac Valve Prostheses.
• Durability Testing
• Pulsatile-Flow Testing
• Steady Flow Testing
We also offer non-accredited testing services for clients seeking quicker, less costly Preliminary Evaluation
and Feasibility Testing.
ViVitro Labs is a member of the ISO standards working committee and is actively engaged in developing
testing standards to assist in regulatory submission. ViVitro Labs ensures that test protocols will meet
evolving regulatory requirements.
Cardiovascular Device TestingFor new classes of cardiovascular devices without existing testing standards, we break down complex
device and pathophysiology into a justifiably simplified bench top test. Each will have well defined:
• Operating conditions [inlet pressure, outlet pressure, internal chamber pressure (if applicable), inflow, outflow, relevant mock heart chamber pressures, cardiac output, and systolic duration]
• Test fluid properties (Chemical composition, temperature, viscosity, density, pH)
• A priori defined acceptance criteria such as acceptable pressure drops, retrograde flow, etc.
Our test plans and reports are designed around approval bodies, thoroughly researched, and justified to
ensure they are regulatory appropriate. Contact us today to discuss your cardiovascular testing needs.
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Lab Services Customer Feedback
Lab Services Customer 8.8/10 Overall Satisfaction
Occluder Testing 9.1/10 “We look for professionals with quality products used for
testing. Someone we can trust, that can give us ideas. It’s
important to work with peers for information.”
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Ventricular Assist 10/10 Device Testing
“We value their experience. They really know what they are
doing. We appreciate all the support they are giving us;
everyone is very cooperative.”
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Transcatheter Mitral 9.3/10 Valve Testing “ViVitro’s Lab Services greatest strength is its experience.”
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Transcatheter Mitral 9.5/10 Valve Testing“Flexibility of test dates, technical expertise.”
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Shunt Testing Quote from Market Research Feedback
“We’re such a new device and we’re not a valve. We did
testing early on with an early generation device. Quite
frankly I’ve been very pleased with all my interactions with
you guys. You’ve been really good about getting everything
together, communicating and following up.”
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Customized TestingIn-house experts develop testing solutions unique to your device, ensuring the right tests are conducted to determine device safety and efficacy.
Like our test equipment, ViVitro laboratory testing includes
heart valves, artificial hearts, Left Ventricle Assist Devices
(LVAD), Occluders for Left Atrial Appendage closure (LAA)
and Atrial Septal Defects (ASD), and other cardiovascular
devices.
• On-call subject matter experts
• Integral part of a client’s team
• Experience and knowledge base for reliable results
• Dependable and immediate service
• Advice or partnerships
Time to Market
We understand how critical your timelines are. We work to
your schedule and deliver on our commitments.
Free Set-up Consultations
All of our “in vitro” studies are developed via no-cost, no
obligation, collaborative consultation. We design unique
tests to meet specific developmental or regulatory needs.
Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all
services, including initial consultation.
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Pulsatile Flow
We use ViVitro Pulse Duplicator and SuperPump
equipment to document pressure and flow
performance characteristics for Valves
(Transcatheter, Biological, Mechanical, Venous,
Conduits) and other cardiovascular devices
including:
• Ventricular Assist devices (VAD, LVAD, RVAD) (ISO 14708-5:2010 Annex DD)
• Total artificial hearts (TAH) (ISO 14708-5:2010 Annex DD)
• Occluders or Closure Devices (ASD – Atrial Septal Defect, PFO – Patent Foramen Ovale, ASO – Atrial Septal Occluder, VSD – Ventricular Septal Defect, PDA Patent Ductus Arteriosus, PLD – Paravalvular Leakage Device)
• Valvular repair or reconstruction devices
• Shunts
• Intra-aortic balloon pumps
Obtain key indicators of performance:
• Leakage rate
• Forward flow pressure drop
• Other design-specific parameters
Receive qualitative high speed video and
high resolution photography of devices in
operation. Simulate pathophysiologies including
hypertension, hypotension, and arrhythmias.
Steady Flow
We test for steady forward flow or reverse flow
leakage using the ViVitro steady flow bench. Burst
testing measures the hydrostatic load at which
failure occurs and is useful for determining failure
modes of devices.
For new classes of cardiovascular devices without
existing testing standards, we break down
complex device and pathophysiology into a
justifiably simplified bench top test.
Hydrodynamic Testing
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Durability TestingWe offer unlimited capacity for ISO 17025 accredited durability assessment and expedite time to market.
Our bank of HiCycle durability testers allows millions of test cycles to be accumulated in a short period
of time. ViVitro Real-Time Wear Testers provide quasi-real-time rates for additional physiological failure
mechanism data.
Dynamic Failure Mode:
Potential failure modes of devices associated with structure deterioration should be identified and well
understood. We test a device sample until failure after it has successfully survived the target lifetime.
Alternately we obtain faster results by increasing the cycling rate and/or device load.
Testing Outputs:
• Well documented operating conditions and resulting device performance
• Assessment of Pass/Fail criteria if applicable
• High-speed videography and daily visual inspections for feedback and peace of mind throughout the process
• High resolution photography and microscopy (including SEM) for wear characterization
• Optional calcification of devices
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Endovascular TestingWe use the ViVitro Endovascular (EV) Simulator to test and document endovascular device
physiological pulsatile flow and pressures. Powered by the ViVitro SuperPump, the EV Simulator’s
programmable waveform system provides physiological pulsatile flow. We test cardiovascular medical
devices and delivery systems by adding anatomical models, including abnormalities or custom patient-
specific modeling.
ViVitro Laboratory tests demonstrate that devices can be delivered and deployed in a safe, consistent
and accurate manner within the intended implant site and with intended use conditions.
• Stents
• Stent Grafts
• Balloons
• Wires
• Coils
• Filters
• Transcatheter Heart Valves
• Occluders
• Shunts
• Valves
• VADs
EV Simulator testing evaluates:
• Pulsatile Flow Interactions
• Positioning
• Deployment Accuracy
• Sizing
• Conformability
• Trackability and Pushability
• Torquability
• Securement Measuring
• Deployment Force
Assess:
Ex-Vivo TestingWe use the ViVitro SuperPump with an excised heart incorporated into a circulatory loop to
generate physiological flows for ex-Vivo simulated use testing. This provides the anatomical
and functional clinical similarity needed for testing of some transcatheter devices. The ex-Vivo
beating heart combines the anatomical and functional clinical similarity with physiological flow
and pressure signatures.
Pressure transducers acquire the aortic, ventricular and mitral pressures. A flow meter
measures the cardiac output of the simulator. Access sites at the aorta, atrium and apex
allow for the insertion of devices. Valve movement is investigated with an endoscope and a
transthoracic ultrasound probe. Pathological states, such as low ejection fractions and high beat
rates, are simulated as loading conditions on the heart by control of the pulsatile pump.
Degenerative and functional mitral regurgitation are simulated by severing the mitral chords and
pressurizing the left ventricle, respectively. Assess therapeutic mitral valve repair performance
with a leaflet clipping device.
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The ViVitro SuperPump is a digitally controlled hydraulic piston pump that creates physiological cardiac flows. Unsurpassed in reliability, functionality, and versatility, the AR Series digital technology provides maximum control with precision accuracy. The SuperPump works with ViVitro or independently produced accessories to create reliable cardiac flows for any type of cardiovascular device.
SUPERPUMPThe most widely used computer-controlled pump for cardiac flowsProduct Code: 10647
The SuperPump AR is pre-loaded with up to 5 waveforms stored on the controller which enables the pump to
be used as a standalone device. Custom waveforms may also be stored on the controller for standalone use.
The ViVitro SuperPump AR Series can be driven by external waveform sources giving flexibility for waveform
input. Function generators, personal computers with I/O functionality, custom hardware, microcontroller
development boards, and even smartphones can directly control the flow output of the pump. SuperPump
feedback can be captured using an oscilloscope or other acquisition device to monitor waveform accuracy.
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> SpecificationsDimensions Pump Controller
15 x 55 x 17 cm11 x 48 x 33 cm
Dry weight Pump Controller
7.65 kg4.7 kg
Voltage 90 - 240 VAC / 50 - 60 Hz
Cycle Rate 3 – 200 BPM
Displacement Volume
0 – 180 mL/stroke
Piston Area 38.32 cm2
Waveform Accuracy
< 4% of Stroke Volume at 70 BPM (±3 mL @ 75 mL/stroke)
< 5% of Stroke Volume at 200 BPM (±3.8 mL @ 75 mL/stroke)
Pressure Limit 360 mmHg* * Pressure limit varies depending on operating conditions
Standard Waveforms
Physio at 70 BPM - (complex physiological waveform)
Sine 30% at 45 BPM
Sine 35% at 70 BPM
Sine 50% at 70 BPM
Sine 50% at 120 BPM
Sync Pulse +5V signal for 10ms duration
Adjustable from 0 to 2000ms delay
SuperPump and SuperPump controller with close up of SuperPump controller display
> Testing Capabilities and Applications• Heart valve function testing
• Peripheral devices
• Vascular devices
• Aortic Valve By-Pass
• LVADs simulator
• Flow transducer evaluation/calibration
• Isolated heart driver
• Echo Doppler flow phantom
• Neurovascular studies
• Blood vessel flow studies
• MRI studies
• Bioreactors & Incubators
• Applications requiring physiological flows and pressure
• Other cardiovascular devices
Current Amplitude
Counter
Current Stroke Volume
Sync Output Delay
Current Waveform
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Optional - ViVitro ViVigen software enables users to create and
upload custom waveforms to the SuperPump. Sinusoidal or linear
waveforms can be modified with the ViVigen interface. Complex
waveforms can be created numerically in a spreadsheet for more
precision. Waveforms are sent via USB interface from the computer
directly to the controller. ViVigen software is intended for third party
testing systems, and use with wide ranges of waveforms.
ViVitro ViVitest software is the most advanced solution for the ViVitro SuperPump AR Series system.
It includes all of the waveform generation and review capabilities of ViVigen software, but drives the
controller directly during testing. There is no limit to the number of waveforms that can be stored in
ViVitest. Users can quickly change between large numbers of waveforms. ViVitest also offers advanced
waveform control features such as custom wavetrains with up to 10 unique waveforms and custom cubic
spline interpolated wavefrom generation with up to 20 segments.
Easy-to-read user screens from ViVigen and ViVitest software
ViVigen + ViVitest Software
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The ViVitro Viscoelastic Impedance Adapter (VIA) works in conjunction with the SuperPump 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 Fixed Resistance: 200 c.g.s. units
Compliance Air Volume: SOURCE 0-120 mL, OUTPUT 0-60 mL, syringe adjustable
Total Liquid Volume: 500 mL with SOURCE / OUTPUT compliance air volumes zero
Materials: Acrylic, Polycarbonate, Delrin, Nylon, Polyethylene, Stainless Steel, Viton
The ViVitro Pump Head can be used with the ViVitro SuperPump to create a circulatory, pulsatile flow loop. The Pump Head accommodates ventricular pressure monitoring using Luer fittings. It may be mounted directly to the SuperPump or can be used in conjunction with the ViVitro Viscoelastic Impedance Adaptor to attenuate pressure traces.
Features:
• Silicone ventricle membrane to isolate SuperPump piston from test fluid
• Low closing volume spring loaded disc valves
• 19 mm (3/4”) hose connectors
• Easy to debubble
• Easy to disassemble and clean
Viscoelastic Impedance Adapter (VIA)Product Code: VIA7991
Pump HeadProduct Code: 16796
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PULSE DUPLICATORMost cited in-vitro cardiovascular hydrodynamic testing systemProduct Code: 18363
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, Flow Measuring System and ViVitest Data Acquisition System. 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.
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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.
> Features• Meets ISO 5840 requirements to collect and analyze flow and pressure
readings in real-time
• Controls pulsatile fluid flows to simulate cardiac flow conditions including arrhythmia, normal, hypo and hypertensive states at specified cardiac outputs and beat rates
• Measures wall pressures in the atrium, ventricle, and aortic outflow
• Measures flow at the aortic or mitral sites
• Simulates cardiovascular peripheral resistance and compliance
• Ventricle membrane replicates natural chamber flow
• Enables echo imaging, Doppler flow measurements, and PIV for interrogation of flow field regions
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> 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)
> Specifications
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
Temperature Range Ambient up to 40°C ± 1.0°C
Flow Rate 0 – 15 L/min
Heart Beat Rate 3 – 200 BPM
Valve size Aortic Mitral
Up to Ø 35mm Up to Ø 35mm*
* Ø 55mm with Large Atrium Accessory
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The ViVitro Left Heart Model 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.
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
Left Heart ModelProduct Code: SD2001-1
Large Atrium Chamber (Mitral)Product Code: 21179
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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.
ViVitest Data Acquisition System (DAS)Product Code: 08530 // Related Part Numbers: 08311 I/O Module, AP9991 AmPack
The software is pre-installed
on a laptop and tested with all
hardware and A-D converters
prior to shipment.
Each system includes the
following components:
• I/O Module – inputs/outputs signals from the software
• AmPack - Pressure Measuring System including transducers and amplifier
• Connecting cables
• Laptop
• ViVitest Software (compatible with Windows 7 & 10)
ViVitest features an intuitive User Interface
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> Pulse Duplicator AccessoriesViVitro Labs offers a wide variety of accessories and equipment to support the Pulse Duplicator.
Customization services are always available to meet unique test requirements.
The Inflator Syringe includes a plunger lock and finely 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 Viscoelastic Impedance Adapter (VIA) works in conjunction with the SuperPump to produce more realistic physiological ventricular pressures. It consists of a fixed resistive element and two adjustable compliance chambers to simulate ventricular viscoelastic behavior.
Please see the detailed accessory overview on page 12.
The ViVitro Aortic Conduit Mount (ACM), formerly the Left Ventricular Outflow Tract (LVOT), is used to mount a compliant conduit, native or synthetic root, and test percutaneous valves in the ViVitro Model Left Heart system.
The ACM enables valves to be sutured, or Transcather valves to be mounted, in an anatomically correct fashion. A variety of ACM sizes are available to accommodate silicone tubes with relaxed tube IDs of 12-29 mm. Custom sizes are available upon request. A compliant conduit may be expanded up to approximately 50mm OD.
Inflator SyringeProduct Code: 26365
Viscoelastic Impedance Adapter (VIA)Product Code: VIA7991
Aortic Conduit Mount (ACM)Product Code: 18903
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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).
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
Pressure TransducersProduct Code: Pulse Duplicator HCM018 // HiCycle 06146
PIV Load AssemblyProduct Code: 21026
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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
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
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 ThermometerProduct Code: 24086
Heat Exchanger and Heat BathProduct Code: Heat Exchanger - HE9991 // Heat Bath Temperature Controller - 10679 N.A., 10680 Int’l
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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 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
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
Catheter AccessProduct Code: Transfemoral Access - 18497 // Transapical Access - 18496
QCtest SoftwareProduct Code: 26066
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The ViVitro Production 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 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 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
Production TesterProduct Codes: 26066, 31989 & 31991
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ViVitro Labs Family of Testing Products and Services for Heart Valves and other Cardiovascular Devices
Real-Time Wear Tester (pg. 27)
HiCycle Durability Tester
(pg. 29)
SuperPump (pg. 9)
SuperPump (pg. 9)
Endovascular Simulator (pg. 25)
Pump Head (pg. 12)
Mitral HiCycle Durability Tester
(pg. 31)
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ACCESSORIES FULL SYSTEMS
ViVitro Labs Family of Testing Products and Services for Heart Valves and other Cardiovascular Devices
Real-Time Wear Tester (RWT)
(pg. 27)
HiCycle Durability Tester
(pg. 29)
Stroboscope (pg. 33)
Digital Manometer
(pg. 34)
HiCycle Cart (pg. 33)
Production Tester (pg. 22)
Pulse Duplicator (pg. 13)
Viscoelastic Impedance
Adapter (VIA) (pg. 12)
Large Atrium Chamber (Mitral)
(pg. 16)
Heat Exchanger
(pg. 20)Heat Bath
(pg. 20)
Aortic Conduit Mount (ACM)
(pg. 18)
PIV Load Assembly
(pg. 19)
Transfemoral Catheter Access
(pg. 21)
Transapical Catheter Access
(pg. 21)
Endovascular Simulator Tray & Compliance
(pg. 25)
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ENDOVASCULAR SIMULATORDevice simulation testing and trainingProduct Code: Tray 30543 // Compliance 25654
The ViVitro Endovascular (EV) Simulator creates physiological pulsatile flow and pressures for testing many types of cardiovascular devices. It addresses requirements of ISO 5840, ISO 25539, and ISO 7198 standards as they include simulated use guidelines. Use the EV Simulator in simulated-use testing and simulation training of cardiovascular devices.
Control a live cardiac flow in a standalone
configuration. Using the ViVitro SuperPump,
EV Simulator’s programmable waveform
system delivers physiological pulsatile flow.
Test a variety of endovascular medical
devices and delivery systems by adding
anatomical models, including abnormalities
or custom patient-specific models.
• SuperPump and Controller
• Viscoelastic Impedance Adapter
• Pump Head
• Flow Measuring System
• ViVitest Data Acquisition System
• Heat Bath and Heat Exchanger
• Pressure Transducers
• Digital Thermometer
The EV Simulator is compatible with the
following ViVitro products:
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SuperPump Controller
Anatomical Model
CameraModel Mounting Tray
Catheter Insertion
Data Acquisition
System
Compliance Chambers
Pump Head (contains Ventricle)
Viscoelastic Impedance
Adapter (VIA)
SuperPump AR
• Pulsatile Flow Interactions
• Positioning
• Deployment Accuracy and Force
• Sizing
• Conformability
• Trackability and Pushability
• Torquability
• Securement Measuring
• Createandcontrolphysiologicalflowsand pressures
• Simulate percutaneous entry and arterial deployment
• Simulatewidevarietyofconditions
• Compatiblewithcardiothoracic,coronary,neuro,abdominalmodels
• Custom models (diseased and patient specific)available
• Compact,versatiledesigntoaccommodate a variety of anatomies
• Standalone capability
• PoweredbytheSuperPump
> Features
Simulated-use TestingUse the ViVitro EV Simulator to
demonstrate that devices can be
delivered and deployed in a safe,
consistent and accurate manner
within the intended implant site and
with intended use conditions.
Endovascular Simulation TrainingThe EV Simulator offers a
clinically relevant practice
model for physicians. Visible
anatomy offers feedback while
navigating anatomical structures
and abnormalities that may
be encountered during actual
procedures.
Physicians sharpen their skills
and increase their confidence in
a safe and realistically simulated
environment. Learning a delivery
system while experiencing
physiological pulsatile flow and
pressures encountered when
maneuvering stents, catheters,
wires, balloons, heart valves and
other endovascular devices instills
invaluable feedback.
• Stents
• Stent Grafts
• Balloons
• Wires
• Coils
• Filters
• Transcatheter Heart Valves
The EV Simulator provides functional design
testing for:
Assess:
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REAL-TIME WEAR TESTER (RWT)Product Code: 20174
The ViVitro Real-Time Wear Tester (RWT) is a quasi-real-time wear tester for heart valve replacements, venous Valve replacements, occluder devices, cardiac patches or strips, medical sutures, staples or clips, and other cardiovascular devices. It is customizable for devices and device mounting arrangements (including conduit mounted valves and large prosthetic heart valves).
The RWT gives users full control over the waveform driving the system while testing numerous devices simultaneously.
With the Hitest Data Acquisition System, RWT operators are able to collect and
analyze pressure data according to ISO5840 standards through an intuitive user
interface. Quasi-real-time results may identify failure modes similar to animal tests for
prosthetic heart valves.
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> Features• Operator control over input waveform
• User interface designed for easy waveform download
• Controller stores up to 5 waveforms to drive the SuperPump
• Visible operation for easy viewing and image capture of testing in progress or real-time inspection
• Easy access cartridges allow quick valve change-out
• Tests up to six devices simultaneously
• Durability and fatigue testing up to 200 BPM
> Testing Capabilities• Heart Valve Replacements
• Venous Valve Replacements
• Occluder Devices
• Cardiac Patches or Strips
• Medical Sutures, Staples or Clips
• Other Cardiovascular Devices
> Specifications
Device Capacity 1 - 6
Dry Weight Controller: 8 kgActuator + Tank: 46 kg
Dimensions 95 x 37 x 43 cm
Tank Volume 30 L
Temperature Control up to 40°C ± 0.5°C
Resettable Cycle Counter 0 – 99,999 Million – resolution of 1,000 cycles
Cycle Rate 3 – 200 BPM
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HICYCLE DURABILITY TESTERProduct Code: 15809 // Related Part Numbers: 16587 HiCycle Module, 11270-B HiCycle Controller, 08531 Data Acquisition System, 08311 I/O Module, AP9991 AmPack, HiCycle Cart HCM200
The ViVitro HiCycle Durability Tester is used to determine the durability of replacement heart valves and other cardiac devices under physiological loading for R&D and regulatory submissions.
With the Hitest Data Acquisition System, operators can monitor pressure and collect data according to ISO 5840 standards.
The HiCycle system uses an electrodynamic
motor driving six pistons within fluid-filled,
temperature-controlled chambers to move
the device rather than the fluid. This results in
higher energy efficiency and stable fluid flow.
The devices can be cycled at accelerated rates
up to 1,800 cycles/minute (30 Hz).
Clear viewports allow imaging of the device
during testing, and pressure ports allow
monitoring of the dynamic pressures
upstream and downstream of the device.
Each test chamber is independent of the
others to offer testing flexibility.
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> Specifications
> Features• Test Up to 6 device designs simultaneously
• Electrodynamic drive mechanism is quiet, stable, and reliable
• Temperature controlled
• Independent chambers allow quick device change-out and start up
• Rotatable Scan-Valve with mounted transducers for quick pressure collection
• Angled windows assist in chamber de-bubbling
• Transparent materials provide flow and device visualization
• Adjustable sync pulse to output for synchronization
Dry Weight Module: 25 kgController: 8 kgCart: 18 kg
Dimensions without Cart Module: 64 x 30 cm ØController: 43 x 34 x 15 cm
Dimensions with Cart 57 x 58 x 132 cm
Cycle Rates 500 – 1,800 CPM (8.3 - 30 Hz)
Temperature Range up to 40°C ± 0.5°C
Operating Pressure Head 0 – 65 mmHg
Volume per Chamber 280 mL
Working Height for Valve 5 cm
Device Diameter <= 35 cm
Valve Mounting custom silicon rubber rings fabricated using jig provided
Flow Restrictors one in each chamber with index dial range 0 - 100% in 2% divisions
Cycle Count 8 digit front panel LCD, to 99,999.999 million
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Mitral HiCycle Durability TesterProduct Code: 27616
This enhanced version of the ViVitro HiCycle Durability Tester supports mitral valve durability testing for devices up to 55 mm in diameter. The Mitral HiCycle tests up to three devices simultaneously.
The Mitral HiCycle system uses the same electrodynamic
motor as the original ViVitro HiCycle to drive three pistons
within fluid-filled, temperature-controlled chambers
moving the device rather than the fluid. The result is more
stable fluid flow. Cycle rates are adjustable from 500 –
1,800 CPM (8.3 - 30 Hz).
The Mitral HiCycle is fully compatible with all the other
ViVitro HiCycle components and accessories including:
• Data Acquisition Software
• HiCycle Cart
• Bellows
• Stroboscope
• Manometer
The Mitral HiCycle is available as a complete
system or an upgrade kit can be purchased
to convert existing HiCycles.
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ViVitro offers a family of quality data acquisition software products to aid
in the collection of data to meet ISO5840 requirements, including ViVitest,
Hitest and QCtest. The software is pre-installed on a laptop and tested with
all hardware and A-D converters prior to shipment. Each complete system
is supplied with the following components to make up a functional system:
When coupled with the HiCycle or the Real-Time Wear Tester, Hitest provides the most powerful, user-
friendly tool for durability testing. Operators are able to monitor pressure and collect data through an
intuitive user interface. Hitest provides accurate pressure data and statistical analysis to ensure the
tested devices are meeting ISO5840 standards.
The results highlight the percent of cycles and percent time per cycle the device is meeting or exceeding
target pressure. Hitest has been designed and validated to meet the stringent requirements of ISO 5840.
Hitest SoftwareProduct Code: 08531
• I/O Module – inputs/outputs signals from the software
• Laptop
• Connecting cables
• Software (ViVitest, Hitest or QCtest)
• AmPack Pressure Measuring System including transducers and amplifier
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HiCycle CartProduct Code: HCM200
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CUSTOMER SUPPORT SERVICES
Technical SupportViVitro strives to ensure 1 day response to all service enquiries whether
by email or phone for support or RMA return of failed products. The
following options are available for all ViVitro systems:
• Repair failed units supported by ViVitro
• Loaner equipment available for lease while unit is being repaired
• Tune unit to original factory specification
• Clean and maintain unit for all parts that experience wear and tear
• Upgrade software to latest revision
• Add new accessories to increase system capabilities
ViVitro can offer a customized annual service contract based on the
above range of services tailored to suit your needs and installed base.
WarrantiesViVitro’s standard warranty is (2) years from date of shipment, and an
extended warranty of up to (5) five additional years is available as a
purchasable option. ViVitro is limited to repairing, or at its option,
replacing without charge, any part which in the sole opinion of ViVitro
proves to be defective within the scope of this warranty. Third party
equipment is subject to the original manufacturer’s warranty.
ViVitro provides full technical support for all products offered. This includes:
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TrainingViVitro offers product training courses that
are available either at the client’s facility or
at the ViVitro factory in Victoria, BC, Canada
to cover essential topics for:
Each course can be tailored to suit your
product configuration and your team’s
training requirements. Class size is typically
limited to five people to ensure adequate
hands-on-time. Training courses cover
system essentials including:
• Assembly, Setup, Calibration
• Running the system
• Collecting Data
• Analyzing Data
• Cleaning and Maintenance
In addition to the above product training,
ViVitro also offers:
• Refresher training for new staff
• ISO 5840 overview
QualificationViVitro offers a 2 day system qualification at the
client’s facility. Included in this service are:
Installation Qualification
• Conformance certificate – safety and emissions
• Calibration and maintenance schedules
• Review of lab facilities
Operational Qualification
• Leakage test
• Ensure client has test protocols
• Functional Test
• Calibration test
• User training sign-off
Performance Qualification
• Test against ISO 5840 requirements for accuracy and range
• Includes testing the accuracy of flow, pressure and drive outputs
CalibrationViVitro’s System Calibration Service confirms
that products and related accessories are
operating to the same specification used at time
of manufacture. Based upon the product, service
areas may include: beat rate, stroke displacement,
position accuracy and waveform. A calibration
certificate is provided with each product upon
completion of the calibration. This service is
available on-site or at the ViVitro factory.
SuperPump 1 day
HiCycle 2 days
Real-Time Wear Tester 2 days
Pulse Duplicator 3 days
EV Simulator 3 days
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DIALOGUES WITH TODAY’S CARDIOVASCULAR PIONEERSEach month ViVitro interviews a leader in cardiovascular research to share and honour their efforts. Here are a few excerpts.
Full interviews at www.vivitrolabs.com/pioneers.
Doug Bernstein, PECA Labs on the challenges and methodologies of pediatric cardiac devices
“We’re one of the few device companies solely focused on the pediatric space—especially for complex class III devices. Other companies have created pediatric devices in the heart valve space, but very few have taken it as their sole focus. The complexities that exist around pediatric cardiac surgery are not similar to adult cardiac surgery. Because our space is in the pediatric space, we end up having these unique anatomies that in a lot of ways are vastly different than in adult devices. It’s crucial to be working with a partner that’s able to customize, develop and adapt to our needs.”
Dr. Arash Kheradvar, UC Irvine on KLAB and cardiovascular engineering
“In Heart Valve Engineering, we’re developing four heart valves in our pipeline and one has graduated to a start-up company. The start-up field is an interesting arena. Access to funds is important. The field is evolving especially in transcatheters space. People come in every day with new ideas. Overall the most important thing is to keep costs low and work with experts. We use your SuperPump with the ViVigen waveform generator and pressure transducer system.”
Dr. Bassil Akra, Director Clinical Centre of Excellence (cCE) at TÜV SÜD, on added value of working with an independent test lab that has ISO 17025 accreditation
“ISO 17025 is not new and presents a method allowing acceptance of testing and calibration results over borders. This standard is used by accreditation bodies to recognize the competence of testing and calibration laboratories that operate in accordance with well-known quality management systems by complying with this standard. In addition to the quality of the results, you gain recognition all over the globe. Because test results, if they are not done by a quality test lab that is following the rules, could be challenged.”
Dr. Michel Labrosse, University of Ottawa, on new framework to help cardiac surgeons plan aortic and mitral valve repair procedures
“The objective of my lab is to improve basic science in cardiovascular mechanics. For example, the description and understanding of soft tissue mechanics, cardiac valve geometry and function, as well as cell mechano-biology. We want our simulations to be as clinically meaningful as possible, and this forces us to carry out experiments as well, to validate our simulations. For example, we’ve run lots of experiments on the human aorta and on the aortic valve. We test the aortic valve in the ViVitro system.”
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CONTACT US
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning or otherwise without the prior written permission of the Publisher.
Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this document, they make no representation or warranties with respect to the accuracy or completeness of the contents of this document and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives or written sales material. The advice and strategies contained herein may not be suitable for your situation. Neither the Publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential or other damages.
HEAD OFFICE
ViVitro Labs Inc.455 Boleskine RoadVictoria, BC, V8Z 1E7, Canada
1 250.388.3531 [email protected] skype: Vivitro.labs.inc.www.vivitrolabs.com
NORTH AMERICADouglas Bigrigg, B. Eng.Major Accounts Manager
ViVitro Labs Inc.455 Boleskine RoadVictoria, BC, V8Z 1E7, Canada
1 250.388.3531 [email protected]
LATIN AMERICA (EXCLUDING MEXICO)Andreluiz de Sousa Cunha
CríonsR. Viamão 1267,LJ8 Belo Horizonte, Brazil30431-253 Brazil
+55(31) 2515-2505 / [email protected]
EUROPE, ISRAEL AND AFRICAKarim MouneimnePresident & CEO
ProtomedLabs SASU24-26 BD Gay LussacImmeuble EnergieF-13014 Marseille, France
+33 4 86 68 68 10 [email protected]
CHINAShining Y. W. Sun沈阳福帝斯科技有限公司Shenyang Fortis Tech. Ltd.
024-23286966 [email protected] www.fortis-hitech.com
JAPANToshiharu MiyakeCEO
Comfort Medical, IncOmagi 1751-1-101Midori-ku, Saitama-shiSaitama, Japan
+33 4 86 68 68 [email protected]
MIDDLE EASTMohan Das
Middle East Medical SuppliesPO Box 38176 Sharjah, United Arab Emirates
+91 9995393624 +97 1506221598 [email protected]
INDIAHarish Rao
Emergent Medi-Tech (I) Pvt. Ltd.116-119 Damji Shamji Industrial Complex 9, L.B.S. Marg, Kurla (West)Mumbai, 400070, India
91-98-20210150 91-22-67825555 [email protected]
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Copyright © 2018 by ViVitro Labs Inc. All rights reserved.PublishedbyViVitroLabsInc.,Victoria,BritishColumbia,Canada
1750_ViVitro_Catalogue(2018)
Address ViVitro Labs Inc. 455 Boleskine Road Victoria,B.C.Canada V8Z 1E7
email [email protected]
phone 250.388.3531
Skype Vivitro.labs.inc.
www.vivitrolabs.com