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Pulse Duplicator SystemUser ManualPulse Duplicator System Including Data Acquisition SystemDocument No. 17473-B ViVitro Labs Inc. 2015Page 1 of 106

Pulse Duplicator System User ManualViVitro Labs Pulse Duplicator SystemDesigned and Distributed by ViVitro Labs Inc., BC, CanadaDisclaimer and Limitation of ResponsibilityViVitro Labs Inc. assumes no responsibility for any damage, loss, or claims which may resultfrom a failure to follow the instructions contained in this manual. Additionally, ViVitro Labs Inc.assumes no responsibility as a result of direct or derived injury, data loss, system malfunctionwhich occurs at the fault of misuse, alternation of the system or incorrect application of use soadvised or directed by ViVitro Labs.CopyrightCopyright 2015 by ViVitro Labs Inc. All rights reserved.Published by ViVitro Labs Inc. Victoria, British Columbia, CanadaLimit of Liability/Disclaimer of Warranty: While the publisher and author have used their bestefforts in preparing this document, they make no representation or warranties with respect to theaccuracy or completeness of the contents of this document and specifically disclaim any impliedwarranties of merchantability or fitness for a particular purpose. No warranty may be created orextended by sales representatives or written sales material. The advice and strategiescontained herein may not be suitable for your situation. Neither the Publisher nor author shall beliable for any loss of profit or any other commercial damages, including but not limited to special,incidental, consequential or other damages.No part of this publication may be reproduced, stored in a retrieval system or transmitted in anyform or by any means, electronic, mechanical, photocopying, recording, scanning or otherwisewithout the prior written permission of the Publisher. Requests to the Publisher for permissionshould be addressed to:ViVitro Labs Inc.455 Boleskine RdVictoria, BC, Canada, V8Z [email protected] 388 3531toll free 877 588 3531fax250 483 1975Document No. 17473-B ViVitro Labs Inc. 2015Page 2 of 106

Pulse Duplicator System User ManualTable of Contents1.About ViVitro Labs . 61.1Cautions and Warnings . 71.2About this Manual . 82.About the Pulse Duplicator System . 93.Pulse Duplicator System Assembly .103.1Unpacking – List of Components .103.2System Assembly Procedure .113.3Accessories Table Installation .233.4Electrical Connections .284.Testing Set-up Procedures .314.1Installation of Valves .314.2Priming the Chambers & Removing Air.324.3Transducer Installation .334.4Peripheral Resistance Adjustment .354.5Compliance Chamber - Volume Adjustment .364.6Compliance Chamber and System Pressure Adjustment .375.ViViTest Software .405.1Software Operation .405.2Software Interface Orientation .415.3Calibration Process Overview .455.4Acquisition Process .485.5Analyze Process .505.6Data Output Options .545.7Compare Process .565.8Review Process .585.9Waveform Design .586.System Calibration .616.1Calibration Wizard Navigation .616.2Pump Calibration – Operational Check .616.3Flow Meter Calibration Setup .626.4Pressure Calibration .696.5Zero Calibration – Measuring Sensor Zero References .72Document No. 17473-B ViVitro Labs Inc. 2015Page 3 of 106

Pulse Duplicator System User Manual6.67.Finishing Calibration – Updating the Calibration File .72System Maintenance .747.1Required Fluid .747.2Draining Fluid .757.3Cleaning Acrylic Parts.757.4Aorta Replacement .767.5Ventricle Membrane Replacement .767.6Piston Seal Replacement.778.Appendix A – Glossary.829.Appendix B – Calculations .8410.Appendix C – Step By Step Guide .8710.1 Summary Test (ref ISO 5840-3 Annex N) .8710.2 Cautions .8710.3 Pulsatile Flow Testing .8810.4 System Setup .8810.5 Calibration .8910.6 Inserting Valves .9010.7 Filling Pulse Duplicator .9010.8 Zeroing the System.9010.9 Tuning System.9110.10 Data Capture .9210.11 Moving Markers .9210.12 Drain / Remove Valve .9611.Appendix D – Wetted Materials .9712.Appendix E – Pump Calibration Procedure .9813.Appendix F – Flow Probe Configurations .10214.Appendix G – End User License Agreement.10314.1 Grant of License .10314.2 Ownership of the Software / Restrictions on Copying .10314.3 Other Restrictions on Use .10314.4 Term .10414.5 Responsibility for Selection and Use of Software .104Document No. 17473-B ViVitro Labs Inc. 2015Page 4 of 106

Pulse Duplicator System User Manual14.6 Limited Warranty, Exceptions & Disclaimers .10414.7 European Software Directive .10514.8 General Provisions .10514.9 Canadian Sales .105Document No. 17473-B ViVitro Labs Inc. 2015Page 5 of 106

Pulse Duplicator System User Manual1.About ViVitro LabsViVitro Labs Inc. offers industry leading cardiovascular test equipment and related laboratorytesting services. Hundreds of organizations in over 39 countries for 30 years have trustedViVitro’s expertise, accuracy, and quality for their cardiovascular device testing.As the developer of the world’s first Pulse Duplicator, the ViVitro name has been synonymouswith cardiovascular device testing equipment. ViVitro hardware and software products havebeen used by leading R&D facilities and academic labs worldwide, and its equipment publications/. The ViVitro Labs’ Pulse Duplicator System(in particular the ViVitro Labs SuperPump) has become a worldwide standard to simulatephysiological heart conditions in academic research applications.ViVitro products are manufactured by StarFish Medical in an ISO 13485:2003 certifiedmanufacturing facility. ViVitro Labs Inc., also holds ISO/IEC 17025 accreditation for laboratorytesting services endorsed by A2LA and based on ISO 5840. This scope of accreditationincludes the physical and mechanical testing of heart valve substitutes including durability,hydrodynamic, and flow visualization testing.ViVitro Labs is widely recognized as the authority on cardiovascular device testing. ViVitroLaboratory Services are engaged worldwide for hydrodynamic, durability, and flow visualizationtesting of heart valves and other cardiac devices. ViVitro has been the trusted name inregulatory approvals for over 30 years and is renowned for its proven success from productdevelopment testing through to full regulatory submission.ViVitro Labs is a member of the ISO 5840 standards committee and is actively engaged indeveloping regulatory requirements. Leveraging this intimate knowledge of the standard, ViVitroLabs ensures that test protocols will meet ever changing regulatory requirements. ViVitro’sLaboratory Testing Services offers an ISO/IEC 17025 certified lab using ViVitro equipment, toconduct 3rd party independent testing. ViVitro’s accredited testing lab is governed by a matureQuality Management System (QMS) certified to meet the ISO 5840. This gives assurance tostakeholders and regulatory bodies that results are obtained by qualified personnel usingtraceable calibrated equipment and up to-date test methods, all supervised by a qualityassurance department.Document No. 17473-B ViVitro Labs Inc. 2015Page 6 of 106

Pulse Duplicator System User Manual1.1Cautions and WarningsPlease read all of the instructions before operating the SuperPump: This instrument is intended for research use only and must be operated by trained labpersonnel. After you receive your Pulse Duplicator, ensure that you let the electrical enclosures sitindoors at room temperature for at least one day before plugging them in. The systems must not be used in environments at higher than 75% humidity. Donot operate SuperPump in extreme humidity or in conditions that can createcondensation. Protect the instrument against dust and moisture, and avoid physicalshock and strong forces. To ensure adequate cooling of the SuperPump controller and pump, place on a clean,flat surface, and be sure that there is at least 10 cm (4 in) of clearance around each sideof the controller and motor end of the pump. Make sure that the fan vent is not blocked. Always connect the power supply to a 3-prong, grounded AC outlet rated 4A, 110–240 Vusing the AC power cord provided with the SuperPump. Do not use an adapter to anungrounded outlet. Before plugging the instrument in, be sure that the correct fuses areinstalled. See the Data Acquisition System User Manual. While SuperPump is designed to withstand spills on its exterior surface, do not allowfluids to enter the interior of the instrument. In the event of such a spill, disconnect thepower cable before cleaning up. Clean the controller and pump exterior with a dry cloth. Use caution when moving the controller and/or SuperPump. Disconnect power andpump cable before moving the system to a new location. Do not use the SuperPump system if there is evidence of physical damage or if thesystem has been dropped or subject to impact. Do not attempt to service the product beyond what has been described in thismanual. All other servicing should be referred to qualified service personnel. Electrical devices pose the risk of electric shock. To reduce the risk of shock, donot open any covers that are fastened with screws.As stated previously please ensure you have read the manual and received training prior tooperating the system. The following are sections which should be reviewed carefully beforeoperating the system as damage may result from improper use:Section 7.1: Only ever fill the ventricle chamber with distilled water - any other fluid maydamage the piston seal or optional VIA accessory.Section 3.2.4: Never over or under pressurize the ventricular chamber. If fluid is added orremoved ensure the ventricle sac remains in a neutral unstressed position.Section 3.2.5: Never turn on the flow meter unless the probe is in contact with a conductivefluid. Operation of the flow probe while exposed to air can damage the probe,requiring replacement. See Carolina Medical user manual for more detailsSection 0: Do not over pressurize the pressure transducers. The transducers are rated to amaximum pressure 350 mmHg. Using a syringe it is easy to generate pressures inexcess of this so take caution when removing air from transducers.As a final caution, do not over-tighten any fasteners, especially those going into acrylic fixtures.NOTE: The user may opt to manipulate the system to achieve alternatestates/results/configurations. Should the user carry this out it should be noted that the pressuresand flows are kept within the limitations of the system to ensure the system is not overloaded.Document No. 17473-B ViVitro Labs Inc. 2015Page 7 of 106

Pulse Duplicator System User Manual1.2About this ManualThis document describes the Pulse Duplicator System’s procedures for: Assembly of the System System Set-up Use with ViViTest Software Calibration System MaintenanceFor details on the individual subcomponents please refer to the following user manuals:1)2)3)4)5)SuperPump AR Series System User Manual – 17476ViViGen Software User Manual – 17474Viscolelastic Impedance Adapter User Manual – 22846DAS User Manual – 20157Valve Mounting Procedure - 24542Document No. 17473-B ViVitro Labs Inc. 2015Page 8 of 106

Pulse Duplicator System User Manual2.About the Pulse Duplicator SystemThe ViVitro Labs Inc. Pulse Duplicator System simulates cardiac conditions to evaluatecardiovascular device hydrodynamic functionality. The system uses a highly adaptable linearpump to compress a silicone ventricle sack, simulating the function of the heart’s ventricle andgenerating pulsatile flow through prosthetic heart valves in a ViVitro Labs Model Left Heart. ThePulse Duplicator simulates physiological or other complex pressure variations which (whenconnected to the ViViTest software via pressure and flow sensors) provides detailed data returnon cardiovascular device and system performance.The diagram below provides an illustration of the fundamental set-up:1. SuperPump2. Ventricle Chamber3. Atrium Chamber4. Aortic Chamber5. Aortic Standoff and Flow Probe6. Compliance Chambers and Tubing7. Peripheral Resistance Controller8. SuperPump Controller9. Viscoelastic Impedance Adaptor (VIA)10. Computer11. Flow Meter (Cables Not Shown)12. I/O Module (Cables Not Shown)13. Ampack, Pressure Transducers(Pressure Transducers and Cables Not Shown)100120367413051110A complete list of components for each assembly can be found in Section 3.1.2Document No. 17473-B89 ViVitro Labs Inc. 2015Page 9 of 106

Pulse Duplicator System User Manual3.Pulse Duplicator System AssemblyThe Pulse Duplicator System requires several steps to assemble the main sub-assemblies. It iscritical for the assembly steps to be followed in order to ensure successful operation.3.1Unpacking – List of ComponentsInspect the shipping container for external damage. Retain the shipping carton and packingmaterials for possible re-shipment. Inspect the system components for damage. If there isevidence of damage contact the carrier, initiate a damage claim, and inform ViVitro Labs. Thefollowing assemblies should be identified on unpacking:3.1.111111SuperPump (08957)SuperPump mounting base (10753)SuperPump Controller (10519)SuperPump Motor power supply cable (11095)SuperPump Controller power supply cable (05728)3.1.2111112111Model Left Heart (SD2001-1)Ventricle chamber (08997)Aortic chamber (SDA000)Atrium chamber (SDC000)Accessories kit (includes 2 compliance chambers, 1peripheral resistance controller and 4 colour codedsilicone tubes) (SDH000)Accessories table (SDH030)Mechanical disc valve (Aortic - SLDV00 and Mitral SLDV00.1)Valve holder moulding kit (05532)3.1.311SuperPump (10647)Data Acquisition System (08530)I/O Module (08311)Pressure Measuring System (AP9991) Includes 3x Pressure Transducers (HCM018)Computer and associated components (06295)ViViTest Software package (15684)Document No. 17473-B ViVitro Labs Inc. 2015Page 10 of 106

Pulse Duplicator System User Manual133USB cable (06630)Short BNC cables (05951)Long BNC cables (05950)3.1.4111Flow Measuring System (FS0992)Carolina Medical Flow Meter (FS0991)Flow probe (09701)Flow probe cable kit3.1.5Optional System ComponentsHeat Exchanger (HE9991)Heat Bath including pump and controller box (10679 / 10680)Digital Manometer (06104)Digital Thermometer (24086)Large Atrium Chamber (21179)Aortic Conduit Mount (ACM) (18903)Transfemoral and Transapical Access Device (18497 / 18496)PIV Load Assembly (21026)Function Tester Load Assembly (18652)Function Tester Camera Mount (18407)QCTest Software – for use with Function Tester components (18347)3.2System Assembly ProcedureThe following steps detail the procedure for assembling the main components outlined above.3.2.1SuperPumpThe SuperPump arrives pre-assembled and ready for use. Place the SuperPump on a fixedstructure, i.e. a table or frame suitable to accommodate the weight and dimensions of the entiresystem once put together. The pump head of the SuperPump should extend over the edge ofthe bench to provide clearance for the ventricle chamber drain. See the SuperPump UserManual for more details on the SuperPump.WARNING: It is recommended that the SuperPump be positioned with its longest dimensionhorizontal. Should the pump be vertically mounted with the pump head above the motor,the possibility of liquid contamination of the mechanical and electrical parts is likely tooccur.Document No. 17473-B ViVitro Labs Inc. 2015Page 11 of 106

Pulse Duplicator System User Manual3.2.2Attaching the VIAFasten the VIA directly to the SuperPump using 3x #8-32 x 1” screws (HCM089) and flatwashers (HCM071.1). Tighten the fasteners evenly and ensure the fasteners are notovertightened.See the VIA User Manual for more details.Tapped #832 holes tofasten toSuperPump3.2.3Attaching the Ventricle ChamberNOTE: The three screws should be tightened evenly and NOT BE OVER-TIGHTENED. Becareful that the bolt entering the blind tapped hole in the Ventricle Chamber does notbottom out when tightened as this could damage the acrylic material of the chamber.Fasten the Ventricle Chamber to the VIA using 3x #8-32 x 1” screws (HCM089) and flatwashers (HCM071.1). Tighten fasteners evenly and be extremely careful not to overtighten anddamage the acrylic.Document No. 17473-B ViVitro Labs Inc. 2015Page 12 of 106

Pulse Duplicator System User ManualVentriclechambertapped #8-32holes:With VIAWith VIAWithout VIAWithout VIA3.2.4Filling the Ventricle Chamber, VIA (if installed) and Pump HeadREQUIREMENTS: 1.5 liters of de-aerated fluid. It is further recommended to use distilled waterwith biocide to reduce bioburden. The use of saline in the pump head, VIA, and ventriclechamber will damage the internal resistive element and piston seal.NOTE: It is recommended that the ventricle chamber be filled with de-aerated fluid to minimizethe formation of small air bubbles which may reduce visibility and introduce artifacts inecho studies.1. Fill the ventricle chamber with fluid via the stopcock located on the bottom of theventricle chamber. This will fill the pump head, ventricle chamber and VIA (if installed).The stopcock on the top of the ventricle chamber will need to be open to atmosphere toallow displacement of air as the pump head, VIA, and ventricle chamber fill with fluid.NOTE: Siphoning fluid from a larger container into the ventricle chamber is effective.Document No. 17473-B ViVitro Labs Inc. 2015Page 13 of 106

Pulse Duplicator System User ManualCLOSEOPENRelevant stopcock positionsDisplaceair hereFillhereDisplaceair hereFillhere2. Close the 2 stopcocks on the VIA (if installed) after the VIA has filled with fluid.3. Fill until the ventricle membrane is slightly compressed. Be sure not to overfill theventricle chamber. This will collapse the ventricle membrane.4. Remove air by syringe via the stopcock on the top of the ventricle chamber. Add fluidas necessary so that the ventricular membrane is not over or under expanded.NOTE: Ensure the SuperPump is set at the “home” position in the centre of its range ofmovement before filling, therefore creating minimal expansion or collapse of the ventriclemembrane during operation. Over pressurization of the Model Left Heart can push thepiston to the fully retracted position, causing a Pump Error to display.Document No. 17473-B ViVitro Labs Inc. 2015Page 14 of 106

Pulse Duplicator System User ManualDebubble the ventricle chamber and pump head by: attaching a syringe to the stopcock on the top of the ventricle chamber; open the stopcock on the ventricle chamber; if VIA installed, close the two stopcocks on the VIA; elevate the whole system at the ventricle chamber by approximately 30º; debubble/remove the air in the chamber as it collect at the top ventriclechamber stopcock; return to horizontal position when debubbling is completed; close the top stopcock on the ventricle chamber and remove the syringe.Debubble the VIA (if installed) top/Source compliance chamber by: attaching a syringe to the stopcock closest to the SuperPump on the VIA; open the stopcock; close the remaining stopcocks: one on the ventricle chamber and the otheron the VIA; tilt the whole system down at the ventricle chamber by approximately 30º; debubble/remove the air in the chamber from the rear VIA stopcock; return to horizontal position when debubbling is completed; close the stopcock and remove the syringe.Debubble the VIA (if installed) internal/Output compliance chamber by: attaching a syringe to the stopcock closest to the Ventricle Chamber on theVIA; open the stopcock; close the remaining stopcocks: one on the ventricle chamber and the otheron the VIA; tilt the whole system down at the ventricle chamber by approximately 30º; debubble/remove the air in the chamber; return to horizontal position when debubbling is completed; close the stopcock and remove the syringe.Adjust the fluid volume of the ventricle chamber so that the ventricle membrane is in a relaxedstate:Relaxed/NeutralOver-Expanded (addventricle chamber fluid)Front ViewOver-Compressed (removeventricle chamber fluid)Document No. 17473-B ViVitro Labs Inc. 2015Page 15 of 106

Side ViewPulse Duplicator System User ManualRemoving Fluid (expanding an over-compressed ventricle membrane): attach a syringe with a fully depressed plunger to the top stopcock on theventricle chamber; check that stopcocks on the VIA are closed (if installed); open the top stopcock on the ventricle chamber; draw back the syringe plunger to remove fluid from the ventricle chamberuntil the ventricle membrane is in a relaxed state; close the stopcock remove the syringe.Adding Fluid (compressing an over-expanded ventricle membrane): attach a syringe that is about ¾ full of distilled water to the top stopcock onthe ventricle chamber; check that stopcocks on the VIA are closed (if installed); open the top stopcock on the ventricle chamber; draw back the syringe plunger the remaining volume of the syringe to removeany air in the tubing; depress the syringe plunger to add fluid to the ventricle chamber until theventricle membrane is in a relaxed state; close the top stopcock on the ventricle chamber and remove the syringe.NOTE: The fluid in the ventricle chamber should be replaced periodically (at least every 2months). If the system is used infrequently, drain fluid from the chamber and allow it todry.3.2.5Flow Probe& Meter Operational CheckThe following has been taken from the Flow Meter Manual, please consult this manual fordetailed instructions. These checks will ensure the flow meter is functioning properly beforebeing installed into the Pulse duplicator, as well as prior to system calibration.NOTE: This should be done for each flow probe and its accompanying flow meter.Warning: Incorrect mains voltage setting will cause damage to the flow meter.Installation Instructions: Check that the correct fuses are installed in the back panel of the unit foryour mains supply (115 or 230 VAC).Document No. 17473-B ViVitro Labs Inc. 2015Page 16 of 106

Pulse Duplicator System User Manual Check that the voltage switch on the back panel of the unit is set for yourmains supply (115 or 230 VAC).With POWER OFF (down) and PROBE switch OFF plug the power cord intothe mains supply.NOTE: The Flow Meter must be properly grounded. It is recommended the flow meter ison its own, isolated power outlet. Connecting it to a shared power bar or outletmay result in noise in the flow signal. Connect the PULS output on the back panel to the I/O Module using thePHONO to BNC cable provided.Connect the 8-pin flow probe plug to the Flow Meter jack with the correctorientation as indicated by the missing pin.Place the flow probe and ground lead into a non-metallic container filled witha conductive fluid, such as saline. (The probe will not function and maybe damaged in air or pure water.)NOTE: When the flow probe is installed in the Pulse Duplicator system, connect theground jack on the front panel of the Flow Meter to the test fluid ground pointcorresponding to the flow probe site. Document No. 17473-BSet the MEAN switch to HI.Set the outer dial on the RANGE switch to give a PFX (probe factormultiplier) of 100.Set the Range dial to 10LThe frequency response recommendation is 30Hz.The PROBE FACTOR should be set to the manufacturer’s recommendation.See label below. The probe factor, shown in the red circle, translates to asetting of 4.38 on the flow meter potentiometer. Reference the probe factorcalibration label provided with the flow probe for proper set-up. ViVitro Labs Inc. 2015Page 17 of 106

Pulse Duplicator System User ManualNOTE: Following the ViViTest software instructions in section 6.3 for flow calibration, thesoftware will automatically create a calibration factor for the flow meter signal toequal the pump dL/dt. If a significant drift is noticed in the flo

Pulse Duplicator System User Manual 1.1 Cautions and Warnings Please read all of the instructions before operating the SuperPump: This instrument is intended for research use only and must be operated by trained lab personnel. After you receive your Pulse Duplicator, ensure that you let the electrical enclosures sit