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PD-002 Pulse Duplicator User Manual

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1. Document No 17473 Vi 3 ViVitro Labs Inc 2014 Page 50 of 1 18 V V Pulse Duplicator System User Manual 8 5 Null Balance and Zero NOTE The following MUST be performed with the system filled with 0 9 NaCl saline solution e With the PROBE switch set to OFF adjust the ZERO control until the display meter reads zero e Set the PROBE switch set to NULL Adjust the NULL control until the display meter indicates a MINIMUM reading e Set the PROBE switch set to BALANCE Rotate the BALANCE control so that the meter reads zero This position should be close to that set by ViVitro Labs Inc during pre shipment calibration e Set the PROBE switch set to either or Normal placement of the probe dictates flow is in the direction If necessary use the BALANCE control until the meter shows zero NOTE If the meter is off scale check for improper grounding or air bubbles in the probe lumen which can be removed using a cotton swab e To verify the flow meter is set and or operating correctly use the ViViTest software flow calibration screen to verify an oscillatory flow when the pump is operating Reference the flow meter manual if the flow meter is suspected of not functioning properly e Turn the PROBE switch OFF when flow is not being monitored or NO test fluid is present NOTE Warning Probe can be damaged if left on when NO test fluid is present e Calibration of the Flow Meter
2. cccccccseececeeeeeeeeeeeeeeeseeeeseeeesseeeeseeeesaeeesees 23 52 GIF1TO0 Slicne Ee Le 24 53 Ring Moulding delen E 25 5 4 Preparation of RTV silicon rublber ccc ccc ceccceeeeceeeeceeecaeeseeeesaeesaeeseeeeaeeeseueeseeesaeeees 25 Ia NMEN EE 26 5 6 De aerating mixture ic sercsudessncsucevncsederancsucevnaciedevancencesencwes ecaneneceseucwossuananecesenaworseanasnsasent 26 6 Pulse Duplicator System Assembly rnnnnnnnnnnnnnnnennnnnnnnnnnnnnnennnnnnnnnnennnnnnnnnnennnnnnnnnnennnnr 27 6 1 Unpacking List Of Components ccc ceeccceeeeeceeeeeeeeeeseeeeseeeeeseseseueeeseueeseeessaeeesaes 27 Er PN 28 6 3 Attaching the VIA and the Ventricle Chamber 28 6 4 Attaching the Ventricle Chamber 29 6 5 Filling the Ventricle Chamber VIA if installed and Pump Head 29 6 6 Accessories Table Installation rarrrnnrernnrrrnnrrnnnrrnnrnranernnrnnnnrrnnnrnnnrnnanennnrnnneennnnennsen 31 6 7 Atrium Chamber INSTAN ANON BE 32 6 8 Aortic Assembly Installation arerarennnrnnnennrrnnnernnrnnnrnnnennnrnnnennnennnrnnnennnennnennnennennsennee 33 6 9 Flow Probe s Initial Operational Check 34 6 10 Installation of Flow brobes 36 6 11 Installing Wie AOMIG Flow PINE E 36 6 12 Installing the Mitral Flow Probe 37 6 13 Aortic Compliance Chamber Installation ccccccccccseececeeeecseeeeseeseseeeeeseeeesaeeessaeeesees 37 6 14 Aortic Room Compliance Chamber 37 6 15 Peripheral Resistance Controller rrrrrarrrrnnner
3. Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 25 of 118 V V Pulse Duplicator System User Manual 5 5 Mixing For making one rubber ring about 15 mil volume of GI 1100 RTV silicone base is required This volume is best measured and dispensed from the silicone base container using a modified 35 ml syringe which has a large hole in the syringe end Proceed as follows 1 2 3 4 5 5 6 Push syringe piston to the end of its travel Insert syringe end into silicone base to a depth of about 2 cm and slowly retract syringe piston to withdraw 15 ml volume Wipe off excess silicone base from syringe end Dispense the syringe contents into the mixing cup Using a 3 ml syringe dispense 1 5 ml of activator into the cup Thoroughly stir the mixture with the wooden spatula Be sure to scrape the sides and bottom of the cup to ensure the correct ratio of base to activator 10 1 Stir slowly until a uniform light blue colour without streaks is achieved De aerating mixture Immediately after mixing de aeration of the mixed rubber to remove entrapped air is always recommended Removing air bubbles helps assure the rubber rings sealing ability and provides uniformly dense rings Proceed as follows 1 2 3 PPEP en 9 Place the mixing cup with the mixed silicone rubber into a small volume vacuum chamber e g part VC9991 365 ml chamber volume Attach a hand operated vacuum pump to the vacuum chamber us
4. 7 6 Peripheral Resistance Adjustment The peripheral resistance can be adjusted to regulate aortic pressure This will also affect cardiac output NOTE The peripheral resistance adjustment will also influence the pressure throughout the system so it is recommended to make incremental adjustments while monitoring the air level of the compliance chambers and mean aortic pressure Care should be taken NOT to occlude the Peripheral Resistance or connection tubing completely This would rapidly cause excess pressure Adjustment of the Peripheral Resistance may also change the Aortic Root external fluid level This level should be adjusted as shown in Section 7 5 1 Rotate the peripheral resistance outer housing clockwise to increase its resistance to flow The vernier scale can be used as a guide for repeatability 2 Monitor the mean Aortic Pressure on the ViVilest software while increasing the stroke volume to ensure that you do not over pressurize the system for concise instructions see ViViTest Software Operating Manual 3 During normal operation the peripheral resistance should be adjusted so that this pressure ranges between 80 and 120 mmHg 7 7 Pressure Waveform Adjustment The shape of the Aortic and Ventricle Pressure waveforms is influenced by the Aortic Root and Aortic Compliance Chambers Additionally the Viscoelastic Impedance Adapter VIA may influence these waveforms In particular reduction of the Compliance Chamber
5. Mean of pressure difference between outflow and inflow of points between P1 to P2 P3 to P4 for Mitral Mean Pressure Drop F mmHg Mean of pressure difference between outflow and inflow of points between F1 to F2 F3 to F4 for Mitral Back Pressure mmHg 1 Mean Pressure Drop F3 to F4 Maximum Pressure Drop mmHg Maximum Pressure Drop value between Points P1 to P2 Mean Aortic Pressure mmHg Mean Aortic Proximal Pulmonary Pressure between P1 to P4 without compensation RMS Aortic Pressure mmHg RMS of aortic pressure F1 to F4 without compensation Peak Aortic Pressure mmHg Peak Aortic Pressure between P1 to P2 Mitral between P3 to P4 Mean Vent Pressure mmHg Mean Vent Pressure between P1 to P4 Peak Vent Pressure mmHg Peak Vent Pressure between P1 to P4 Parameters based on pressure and flow E O A cm 2 RMS Forward Flow ml sec 51 6 Square Root Mean Pressure Drop Density Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 101 of 118 V V Pulse Duplicator System User Manual Parameters based on Energy Energy loss is calculated by integrating the flow times the transvalvular pressure over a relevant flow interval A conversion factor of 0 1333 is applied to convert the energy from mmHg ml to millijoules mj Ventricular energy VE mj Ventricular energy is computed using the following integral F4 mi VE Conversion factor Pent DL Du dt F1 Where the integral is evaluat
6. This completes the static head and final component of the pressure calibration wizard The derived values are listed helow Calculated Values mY mmHg mV mmHg em Wabuiuie Static Pressure Head Difference 17 073 mmHg Aortic pressure wih respect to Ventricukr 17 072 mmHg Atrial pressure with respect to Ventricula Click REPEAT to restart calibration or YES FINISH to accept these values Accept values q oa ml Repeat Yes Finish In the ViVitro Labs Pulse Duplicator System wall pressure measurement sites are not at the same level Experimental determination of the static head pressure differences is the second part of the pressure calibration The Wizard prompts the user to record pressure transducer outputs when they are once again installed in the model e first with atmospheric reference pressure applied and e then with the static head of fluid pressure applied Application of these pressures is readily made by turning the T taps on the transducers For custom systems where pressure transducers are at the same head level zero static head pressure offsets can be entered manually NOTE The calibration factors presented at the end of the calibration collection sequence are related to the accuracy of the pressure data collection It is important to determine internal acceptance criteria for the pressure transducer calibration factor The integrity of your data and quality of the results are rela
7. 7 Testing Set up Procedures The following sections describe the steps required to prepare an assembled system for testing 7 1 Initial Assembly Procedure Refer to Section 6 to ensure the systems initial assembly is complete before continuing Going forward it is assumed that all the hardware and electrical components have been connected The following sections provide the user with the procedures for set up of the Pulse Duplicator System for testing These procedures provide operation for ideal physiological conditions known to ViVitro Labs The diagram below provides an illustration of the fundamental set up and operational depiction SuperPump Ventricle Chamber Atrium Chamber Aortic Chamber Aortic Standoff and and Substitute Probe Compliance Chambers and Tubing Peripheral resistance controller SuperPump Controller Viscoelastic Impedance Adaptor VIA 10 Computer 11 Flow Meter and Connector Cables 12 Flow Probe Not Shown 13 I O Module and Connector Cables 14 Ampack Pressure Transducers and Connector Cables GE oe ee VC Em 14 e The Standard Pulse Duplicator System 10 A complete list of components for each assembly can be found within the Appendices Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 42 of 118 Vi Vit O Pulse Duplicator System User Manual aDS In 7 2 Installation
8. Acquisition Files Allows access to all ACQ files saved for previous valve trials Analog Voltage Information Provides analog voltage information for the flow probe and transducers used within the system Pressure Calibration Values As pressure calibration is carried out the values are represented within this area for reference Flow Calibration Values Provides the flow probe calibration values for reference Analysis Groups Allows the user to create groups of valve trial data for analysis and comparison Users have the ability to select ANA files from the list below to assign them to a group Groups can be cleared and created easily within this area and are saved as GRP files Zeroing Calibration Values Provides pressures flow and pump zeroing calibration values for reference Document No 17473 V1 3 O ViVitro Labs Inc 2014 Pulse Duplicator System User Manual Acquisition Files Trial 1049 03 19 2010 15 09 29 Runbad acq Trial 1049 03 19 2010 15 11 35 Run05 acq Trial 1111 04 30 2010 09 04 58 RunO1 acq Trial 1201T 02 18 2010 11 06 32 RunO1 acq Trial 1216 02 26 2010 15 31 42 RunO1 acq Trial 1216 02 26 2010 15 41 12 Run02 acq Trial 1234555 04 08 2010 08 40 20 RunO1 acq 3 Trial Comparison test 05 04 2010 14 58 02 RunO1 ac Trial Comparison test 05 05 2010 08 45 18 RunO2 ac Trial FFF 04 30 2010 10 25 40 Run01 acq Trial Test1049 03 18 2010 15 52 25 RunO01 acq Trial Test1049 03 19 2010 09 35 05
9. In all cases data in the results panel is a mean of 10 cycles The data table contains details for each waveform Data table button located at the top of the screen Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 69 of 118 10 12 Crossovers and Interval Identification Data analysis proceeds sequentially from cycle 1 to 10 Pressure and flow waveforms are displayed along with crossover markers defining critical intervals during the cycle Automatic algorithms calculate the start and end of the aortic and mitral valve pressure and flow cycles The Data Dashboard is based on these crossover points Units mmHg KPa Ventricular Pressures Volumes EOA Interval I P Rate BPM 86 2 Max mmHg Closing E Stroke ml Se Mean mmHg Leakage Ei ME aS min 1 3 Mee Total Regurge Fu AP mem 5 3 LPM Back SIS mmHg Regurge on AORTIC VALVI Aortic Pressures Yolumes EDA Interval CH 100 0 Eu ere os It Closing P Stroke mi Mean o mmta Leakage HD 11 Min 0 6 mmHg Total Regurge on mi enemy 2 1 re mmHg Regurge Effective Area EQOA NOTE While the algorithms make reasonably good choices on well formed waveforms do not blindly rely on this automatic placement Manually adjust the crossover markers by clicking and dragging on their labels to change their horizontal location to get best results Analysis for Trial 23234234 234234 Date 02 08 201015 15 Focus Waveform 1 Ov
10. Turn the POWER switch on 12 A switch transient may cause the ALARM indicator to illuminate Depress the ALARM indicator to reset the meter Allow ten minutes for the instrument to stabilize NOTE The green READY light should remain on when the meter is measuring flow Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 34 of 118 V V Pulse Duplicator System User Manual 13 NOTE 14 15 16 NOTE 17 With the PROBE switch set to OFF adjust the ZERO control to give a display meter reading of zero The ZERO control is a 15 turn potentiometer and normal setting would be approximately mid position 7 Le turns clockwise from the extreme anti clockwise rotation ZERO control is functional with or without the flow probe attached and the no signal level of the back panel MEAN and PULS outputs are set by the ZERO control The with signal level should be approximately the same as the no signal level under static flow condition With the PROBE switch set to NULL adjust the NULL control until the display meter indicates a MINIMUM reading With the PROBE switch set to BALANCE rotate the BALANCE control so that the meter reads approximately zero This position should be close to that set by ViVitro Labs Inc during pre shipment calibration With the PROBE switch set to either or Normal placement of the probe dictates flow is in the direction If necessary use the ZERO control until the meter shows z
11. channels Positive leakage can also be caused by excessive valve compliance during back pressure and modifications to the valve mounting should be considered as the first source to resolve the problem derived flow is best used when no other solution is available to the investigator The derived flow method calculates the flow for the target valve by placing the flow probe and supplied competent valve i e no leakage in the companion site and computing the flow from the dL dt pump signal Given the check valve is designed not to leak the ventricular flow or pump displacement can be assigned as the target valve flow NOTE The use of derived flow has been validated by comparing derived flow leakage rates with those obtained from leakage column measurements This validation was made using a ViVitro Labs Pulse Duplicator System with left atrium and mitral flow channels in line The method is only valid with NO compliance The VIA and any air in the hydraulic chamber must be removed The competent valve must be used in the companion site and the rectilinear atrium chamber This method is not recommended for the mitral position or with vertical atrium chambers The ViViTest software alternately uses the same prompts for Direct or Derived flow measurements The ViViTest will provide flow measurements for both the aortic or mitral position regardless of the configuration so your choice of target probe site and target valve determines if the measureme
12. pressure and flow F flow Energy Graph displays curve of selected groups for Energy Forward Closing Closed Total in mJ Pressure Graph displays curve of selected groups for Pressure Mean Back Peak Differential Mean Positive Mean Differential forward Mean Differential hybrid Document No 17473 V1 3 _ ViVitro Labs Inc 2014 Page 72 of 118 Vi Vit ro Pulse Duplicator System User Manual Labs Regurge Graph displays curve of selected groups for Regurgitation Total Percent Closing Closed and Leakage Rate NOTE There is no Legend bar for this interface See the help screen for more information 10 17 Comparing Groups of Trials Groups are created by selecting the Groups of Trials buttons p sa ii in the top of the Analysis Groups panel at screen right TargetValve Aortic INE Groups of Trials wb The sequence of creating groups for comparison is as Fem F follows Geroararn Flesivivie Labs VM TestFlesil 002A i AProgram FilesWi itro Labs VivilestiFiles A e select either aortic or mitral Valve Data GProaram FilesWivitre LabsWidiTestFilest1 ODA e select the checkbox to of each ANA file required to I ctProcram Files ViVitro Labs ViviTestFiles 1 0054 create a group with a default name or edit the CilProaram Files Vivito LabslViviTestiilest 007A Create Group box for o custom name kel C Program FilesiViVitro Labs ViviTestiFiles1 0084 4 e add ANA files to the gro
13. 1 133 g ml at 20 C will have a viscosity of approximately 3 2 mPas at 37 C This approximates the viscosity of blood e Any solution used must be mixed to 0 9 NaCl concentration to operate the electromagnetic flow probes properly Volume Approximately 2 liters Zone 2 Fluid Distilled water mixed with an appropriate biocide may be required to reduce the bioburden impact of contamination Contact a supplier for recommendations Zone 3 Fluid Water mixed with an algaecide to prevent algae growth NOTE The fluid surrounding the ventricle in the hydraulic chamber and the VIA fluid is normally distilled water and can remain in situ for a period of time It should however be replaced when bio film contamination compromises visibility In general replace the hydraulic fluid every 2 months If the system is not used for extended periods the hydraulic chamber fluid should be drained and all components cleaned with a soft cotton cloth and detergent and then dried before storage Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 85 of 118 V V Pulse Duplicator System User Manual 12 2 Draining Fluid NOTE Prior to draining the system ensure the flow meter is turned off Operatinig the flow meter without fluid in the system will damage the flow probe To change valves or to disassemble the system the test fluid must first be drained To do this release the drain tube clamp and collect fluid in a container of 2 liters volume R
14. Aortic Chamber and Aortic Compliance Compliance Chamber characteristic resistance which simulates the left aortic functions of Chamber the heart Aortic Provides in conjunction with the Aortic Chamber and Aortic Root Compliance Compliance Chamber characteristic resistance which simulates the left Chamber aortic functions of the heart Mean Atrial Measurement derived from the pressure created between the Atrium Pressure Chamber and the Ventricle Chamber to simulate the left atrial pressure in the heart in the mitral heart valve region Measurement is gained using a Mitral Flow Probe Aortic Pressure Measurement derived from the pressure created between the Ventricle Chamber and the Aortic Standoff to simulate the left aortic pressure in the heart in the aortic heart valve region Measurement is gained using an Aortic Flow Probe Ventricular Pressure created in the Ventricle Chamber prior to the Aortic heart valve Pressure opening DL DT A signal provided by the SuperPump Amplifier indicating the pump s flow rate in liters per unit time dL dt pump flow data represents overall system flow and can be used in conjunction with the flow meter to derive the flow across the valve opposite to the flow meter Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 97 of 118 1 VITTO LabDS inc 18 Appendix F Pump Calibration Procedure 18 1 Resetting Values 1 Run ViVitest Software Select the Calibration Tab Open the calibration
15. CT O La DS inc Pulse Duplicator System User Manual Pulse Duplicator System Including Data Acquisition System Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 1 of 118 V V Pulse Duplicator System User Manual ViVitro Labs Pulse Duplicator System Designed and Distributed by ViVitro Labs Inc BC Canada Disclaimer and Limitation of Responsibility ViVitro Labs Inc assumes no responsibility for any damage loss or claims which may result from 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 malfunction which occurs at the fault of misuse alternation of the system or incorrect application of use so advised or directed by ViVitro Labs Copyright Copyright 2014 by ViVitro Labs Inc All rights reserved Published by ViVitro Labs Inc Victoria British Columbia Canada 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
16. EEE EE 96 16 3 PSTN 96 16 4 Flow Measuring rnrnnnnnnnnnnnnnnnrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnsennsnnnsennsnnnnnnnnennnnnnnennsennnnnnnennnennne 96 16 5 Optional System Components rrrrnnnrrnannrnnnnrrrnnrnnnnnernnnrrnnnnennnnernnnnennnsennansennnnennnssnnnnee 96 17 Appendix E Glossary EE 97 18 Appendix F Pump Calibration Procedure rrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnr 98 18 1 die 98 18 2 Determing Interal Pump Calibration Value rarurrnnnrrnnnrrnnnnrnnnnernnnnnnnnnenrnnnnnnnnennnnnnnnnne 99 193 PANNE 99 18 4 Determining External Pump Calibration Value rrerrnrrrrnnnrrnnnerrnnnennnnenvanrennnnennannnnnnne 99 19 Appendix G Calculations asxernnnvennnnonnnnnennnnennnnnennnnennnnnnnnnnennnnnnnnnnennnnennnnnennnnennnnnen 100 20 Appendix H Step By Step Guide nr rnnnnnnnnnonnnnnnnnnnennnnnennnnennnnnnnnnnennnnnnnnnnennnnnnnnnnennn 103 SEKR 103 20 2 Summary Test ref ISO 5840 3 Annex Nk 104 21 LEGG 0 EEE 104 204 Pulsatile Flow TESIG EE 105 20 5 System SEUD senene ae E Ee E EEE En E EE Ean EEEE 105 BE ANN 106 Se ET ae EE 107 20 8 Filling Pulse Duplicator 2 2 0 cece cece eeec sees cece eene cena eeseeesaeesaeeseeeseeeseeesaeeseeeseeeseeeseeenes 107 20 9 FE SN 107 20 10 Tuning EE EEE EN 108 RE RE e EE 109 20 12Moving Markers nennannennennennennennrnnrnnrrrrrrrrrrrrrrrrrrrrrrrrrrrurrnrrrrrnrrnrrrrrrrrnrrrrrrrrnrrrrrrereene 110 20T Recodo E RE eee eee ee
17. Flex aorta A67 Clamping bolts 6 32 x inch 3 each A68 Outlet tube clamp for Flex aorta common for all sizes A69 Outlet tube female for Flex aorta A70 Bond between aorta and aortic inlet ring lt is recommended that these structures be made from silicone rubber A silicone rubber aorta will bond easily to the other silicone rubber components that are needed using a silicone rubber sealant Custom make the aortic inlet ring from silicone rubber following procedures given in this manual The aortic ring is then bonded to the inflow of the aorta using Dow Corning flowable silicone sealant 734 A silicone rubber O ring is supplied and is bonded to the outlet of the compliant aorta with the same sealant The grey and green tubes are supplied in various ID sizes with internal diameters 13 28mm Appropriate sized silicone rubber O rings are also supplied for bonding to the exit end of the aorta Before mounting the compliant aorta stentless valve and accessories remove the standard glass aorta assembly following the instruction in the operating manual for aorta replacement Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 93 of 118 V V Pulse Duplicator System User Manual 10 11 12 13 NOTE 14 Bond a silicone O ring A62 to the exit end of the desired compliant aorta and mould a silicone rubber inlet ring A65 with an inside diameter
18. Pulse Duplicator System User Manual Waveforms Users with special requirements may be interested in designing new custom waveforms These 4 waveform buttons allow users to load and modify a dual sine waveform a 2 line waveform a spline waveform and a wavetrain After a custom waveform is designed it is then saved asa WVF or WVT file Users create a custom sine or 2 line waveform by dragging the bottom point of the 2 line V or dual sine valley in the X direction until the desired shape is achieved DESIGNING NEW PUMP CONTROL WAVEFORM USING 2 SINE FUNCTIONS ViViTest Waveform customization custom sine wave Spline waveforms are created by dragging one or more of the spline points to create a new shape New spline points are created by clicking on the line whereas points can be deleted by right clicking on the point Users select a point along a segment and then drag that point up or down in the Y direction until the desired shape is achieved Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 77 of 118 DESIGNING NEW PUMP CONTROL WAVEFORM USING SPLINE FUNCTIONS 1 Cycle 1024 points ViViTest Waveform customization spline wave Wavetrains are created by selecting one of the saved waveform from the waveform design files on the right hand side Once the file has been selected click on the first box or desired location in the Wavetrain Design window below the graph Users can create a train consisting of a variety
19. Run02 acq J II HEEHEEEE NE AK Analog Yoltage Information Chn volts Std Dev Aortic 1 5 371 2 002 V ntric A 5 694 0 002 Atrial 3 5 311 0 003 dl dt 4 0 181 0 002 Flow 5 0 058 0 001 Pump 6 1 068 0 002 Pressure Calibraton Values Pressure Sensor Calibrato Pressure range min mmHg Pressure range max mmHg Aortic Pressure mmHg Ventic Pressure mmHg Aortic Static Pressure mmHg Atrial Static Pressure mmHg Flow Calibraton Yaluez Flow Sensor Calibraton Flow zeros Channel 0 1965 eee 01346 d Adr mv dml ZG S NGE nalysis Groups kb Aortic wt l Mitral Target Valve Groups of Trials Group1 C Program FilestViVitro LabsViviTestiFiles 1 0014 C Program FilestVi itro Labs ViviTestiFiles 1 0024 C Program FilestViVitro Labs ViviTestiFiles 1 0034 C Program FilestVi itro Labs ViviTestiFiles 1 0044 F Group2 LJ C Program FilestViVitro Labs ViviTestiFiles 1 0054 C Program FilestViVitro Labs ViviTestiFiles 1 0064 C Program FilestViVitro Labs ViviTestiFiles 1 0074 C Program FilesiViVitro LabsiViviTest Files 1 00841 ze gt Zeroing Calibration Yalues Sensor Zero Calibraton Aortic Zero Pressure rt ol Smed Atrial Zero Pressure mnH Derived Flow Zero Reading mml Flow Sensor Zero Reading mml Pump Transducer Zero Reading v Vente era Press Page 81 of 118 I VIL O LabS inc Pump Displacement Calibration Displ
20. V1 3 ViVitro Labs Inc 2014 Page 26 of 118 MiVit Pulse Duplicator System User Manual 6 Pulse Duplicator System Assembly The Pulse Duplicator System has several steps to assemble the main mechanical sub assemblies and a few steps for the electrical components installation configuration NOTE It is critical for the assembly steps to be followed in order to assure successful operation 6 1 Unpacking List of Components Inspect the shipping container for external damage Retain the shipping carton and packing materials for possible re shipment Inspect the system components for damage If there is evidence of damage contact the carrier initiate a damage claim and inform ViVitro Labs by calling 1 250 940 2420 or toll free at 1 877 588 3531 The following assemblies should be identified on unpacking SuperPump Ventricle Chamber Atrium Chamber Aortic Chamber Aortic Standoff and and Substitute Probe Compliance Chambers and Tubing Peripheral resistance controller SuperPump Controller Viscoelastic Impedance Adaptor VIA 10 Computer 11 Flow Meter and Connector Cables 12 Flow Probe Not Shown 13 I O Module and Connector Cables 14 Ampack Pressure Transducers and Connector Cables 15 Molding and Accessories Kit Not Shown EE SN 10 i Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 27 of 118
21. a0 2010 10 250 Rundi sles wi Tri al Test 049 03 19 2010 09 35 05 Run02 a acq 6 LEGEND DATA DASHBOARD ma Rate BPM Stroke mi C O LPM ViViTest Screen Layout 11 1 Top Level Toolbar COMPARING mit 04 28 2010_13 37 12 ATnal Standard controls i the top map toolbar are Open File Open an Acquisition ACQ file for analysis or Analysis ANA file for comparison graphing Save File Used to save an Acquisition file when in Acquisition Process Snapshot Captures a JPG screen snapshot of the user interface See Tooltip for details Print In Analysis or Compare processes users can produce a report HTML of results which can then be viewed and printed in any browser Export CSV Save Acquisition or Compare data to a comma separated value CSV file for further processing Data Table In Analysis process the 10 sequential cycles saved to an ACQ file are analyzed and the resulting means data shown in tabular format Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 79 of 118 Vi Vit ro Pulse Duplicator System User Manual LaDS inc Options Menu Access to all software features and information about ViViTest Minimize Minimizes the software to the windows toolbar to enable the user to carry out other activities on the computer screen ee Exit Closes the application NOTE Most controls on the user interface have tooltips that give a brief explanation of usage whenever the mouse is hovered over t
22. ensure ViViTest is showing a sine waveform for the Pump Vol signal All other signals can be hidden if desired 2 Turn the SuperPump amplitude knob up the values described in the table below Record the controller stroke volume for both the controller display and the ViViTest display Calculate the values for the right hand column Average the results of the 3 calculations should be 197 mL stroke Controller Stroke mL s ViViTest Stroke mL s ViViTest value Controller Value 200 50 E BE Average o oS S y O 18 3 External Gain Value 1 Ensure there is not enough water in the load assembly that when the pump is turned to 100 amplitude it sprays 2 Run the pump with an internal S50_70 waveform up to 100 amplitude Record the maximum stroke volume should be 185 ish Max Stroke mL s 3 Stop the pump Change the input waveform to External Select a 550 70 waveform in ViViTest and hit apply 4 Turn the pump off Turn it back on and enter Calibration Mode Enter Calibration menu 2 Turn the amplitude up to 100 Write down the Max Stroke SE UWS Ube Max Stroke mus Pump Control 5 Adjust the External Gain value until the max stroke in step SE a hor 4 matches the max stroke in step 2 Record the new i E Si bP External Gain value Waveform O SWF External Gain Apply 18 4 Determining External Pump Calibration Value 1 Turn the amplitude to 0 Exit Calibration Mode Repeat the following table using the exter
23. file Calibration cfg Insert New Tab Page Layout References Mailings Review View ud Computer OS C Program Files ViVitro Labs ViviTest Files Logs 24 01 2014 10 41 File folder Waveforms 31 10 2012 4 48 PM File folder Calibration ctg 16 01 2014 4 04 PM CFG File I KE Target Valve AORTIC e _ Zero Offset Calibration cfg 01 06 20129 50 AM CFG File 1 KB Zeros Drift Static mV unit 0 000v 0 000 6 949 59 985 c 0 000v 0 000 0 000 60 090 0 000v 1 00 2 60 171 0 004y 9 000 0 000 2 607 0 000v 000 0 00 7 011 200 000 wm KINGSTON E G Production E ViviTest Calibration file cfg Filename Werther D Determining Internal Pump Calibration Value in ViViTest 2 Turn the amplitude to zero 3 Select the Pump calibration tab 4 Change the Linear Transducer Ch 6 value to 200 000 mV mm Verify that the Piston Area is set to 38 32 cm2 Select Accept 5 Select the Calibrate Tab This saves changes to the calibration file Calibration cfg Close the print preview dialog box Select the Calibrate Tab Open the Calibration cfg file this process saves the 200 000 mV mm value ere 16 Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 98 of 118 Vi Vit A O Pulse Duplicator System User Manual ADS In 18 2 Determing Interal Pump Calibration Value 1 Turn the SuperPump Actuator on Set the internal waveform to 550 70 Adjust the amplitude knob to an arbitrary value and watch to
24. matching the inflow end of this aorta A64 Select matched sized tubes A66 and A69 appropriate to the size of the aorta being attached With the clamp A68 detached insert the green tube A69 into the aortic assembly housing and secure with the two clamping washers and bolts A35 Place the outlet tube clamp A68 over the green tube A69 temporarily leaving the bolt A63 loose Attach the catheter A10 to the grey outlet tube A66 using the catheter clamp and bolts A8 Mate the grey A66 and green A69 tubes and rotate the yellow clamp A68 so that the three bolt A67 holes align Tighten the clamp screw A63 Insert the aorta exit O ring A62 between the grey A66 and green A69 tubes and clamp using the three supplied bolts Insert the inlet of the aorta into the silicone rubber inlet ring A65 and before bonding the two components together assure that there is no twisting or buckling of the aortic walls Once the bond is secure remove the aorta from the assembly and proceed with mounting the stentless aortic valve into the compliant aorta This process may involve suturing the valve the inside of the aorta Resulting suture holes and sutures can be reinforced and sealed with a bead of silicone sealant on the inside and outside of the aorta In this regard silicone rubber sealant will vulcanize in water and therefore allows tissue type stentless valves to be kept moist With stentless valve and aorta
25. meter and AmPack are set for your supply voltage BEFORE connecting to the power supply Ensure that the operating voltage of the Heat Bath is correct for your region before connecting to the power supply 2 Where the voltage setting is incorrect adjust the setting manually according to the hardware s instructions 3 Where it is necessary to adapt the power supply plugs the following line cord colours should be observed black phase Miiiicmuctiunl green ground The diagram on the following page shows a schematic detailing the electrical connections that need to be made to make the system operational The following table details these connections Diagram Colour Hardware From Label Hardware To Reference Red AM Pack Bottom Left Aortic Chamber Aortic Transducer Dark Red AM Pack Bottom Right I O Module CH 0 INPUT Yellow AM Pack Middle Left Ventricle Chamber Transducer PULSE gt Flow Meter Probe BE Aortic or Mitral Flow Flow cation Probe Black Flow Meter Ground Aortic Mitral Grounding Pin Standoff CH5 gt Bien Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 40 of 118 Vi Vit ro Pulse Duplicator System User Manual Labs inc 6 19 Electrical Connection Diagram AORTI INPUT OUTPUT VO MODULE Electrical connections for the Pulse Duplicator System Document No 17473 V1 3 ViVitro Labs Inc 2014 USB TO COMPUTER JJ 900 Page 41 of 118 MiVit Pulse Duplicator System User Manual
26. not agree to these terms and conditions promptly return the case containing the Software and the accompanying items including written materials for a refund This is a license agreement and not an agreement for sale 21 1 Grant of License ViVitro Labs grants to you a nonexclusive license to use the Software and the printed and or electronic user documentation the Documentation accompanying the Software in accordance with this Agreement If you have paid the license fee for a single user license this Agreement permits you to use one copy of the Software on any single computer provided that the Software is in use on only one computer at any time The Software is in use on a computer when it is loaded into the temporary memory i e RAM If the potential number of users of the Software exceeds the number of licenses you have purchased then you must have a reasonable mechanism or process in place to assure that the number of computers on which the Software is running concurrently does not exceed the number of licenses purchased ViVitro Labs reserves the right to embed a software security mechanism within the Software to monitor usage of the software to verify your compliance with this license Such a security mechanism may store data relating to the use of the Software and the number of times it has been copied ViVitro Labs reserves the right to use a hardware lock device license administration software and or a license authorization key to c
27. or 1 5 liters with VIA via the stopcock This will fill the pump head ventricle chamber and VIA if installed Fill until the ventricle membrane is slightly compressed Be sure not to overfill the ventricle chamber which will collapse the ventricle membrane CLOSE OPEN Relevant stopcock positions Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 29 of 118 VIA Pulse Duplicator System User Manual SuperPump Priming with Fluid Without VIA SuperPump Priming with Fluid With VIA 2 Close the 2 stopcocks on the VIA if installed 3 Remove air by syringe via the stopcock on the ventricle chamber This involves adding a predetermined amount of fluid and removing an equal amount of air so that the ventricular membrane is not over or under expanded Debubble the ventricle chamber and pump head by attaching a syringe to the stopcock on 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 30 debubble remove the air in the chamber return to horizontal position when debubbling is completed Debubble the VIA if installed by attaching a syringe to the stopcock closest to the ventricle chamber on the VIA then e open the stopcock on the VIA e close the remaining stopcocks one on the ventricle
28. pressure in mmHg P final static pressure in mmHg Conversion factor I mmHg 1333 2 Dynes cm The following graph shows experimental data for contained air volumes versus compliance Initial static pressure P ranged from 0 to 120 mm Hg Best fit linear equations are given for the four data lines It can be seen that in a contained air volume as initial pressure condition increases compliance decreases Air volume max values that were experimentally found appropriate for simulating left ventricle aortic root and systemic arterial compliance are Left ventricle Source compliance air volume 120 ml output compliance air volume 50 ml Aortic root 640 ml Systemic arterial 615 ml These air volume compliances helped provide realistic pressure and flow wave forms under pulsatile flow conditions Air volumes less than these can simulate various patho physiologic or stiffened tissue conditions where tissues may exhibit less compliance Air Volume Compliance VSI Air Compliance Calib xIs 29 Jan 13 Feb 2002 TNS LNS Initial Pressure P mm Hg Fag 1 1 e mg r Compliance x 10 6 cm dyne Wi oa CH 100 200 300 400 500 600 Air Volumemax ml Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 92 of 118 V V Pulse Duplicator System User Manual 14 Appendix B Installing LVOT Accessories Optional The ViVitro Labs Inc Pulse Duplicator System and aortic system has been used by some clie
29. pressure will increase the ratio of maximum to minimum Aortic Pressure At low stroke volumes e g 35 ml stroke 2 LPM C O elimination of this compliance may give Aortic Pressure wave shapes closer to physiologic ones Normally the Aortic Root Compliance Chamber air volume is left at its maximum value of 640 ml Instructions 1 The tubing to the air compliance chambers can be occluded by closing the plastic clamps These clamps can be closed just prior to reducing pump stroke volume to zero to prevent air bubbles from entering the test fluid flow loop 2 You may also release air from the Aortic Root Compliance Chamber when slowly turning down the stroke volume to maintain the proper water levels This helps to stay prepared for continuous collections Document No 17473 V1 3 _ ViVitro Labs Inc 2014 Page 45 of 118 V V Pulse Duplicator System User Manual 7 8 Viscoelastic Imedance Adapter VIA adjustments The VIA will increase ventricle compliance and reduce the rate of increase of ventricle pressure during ventricle contraction The VIA action consists of the resistance element and two air compliance chambers e Vary the volume of air in the output chamber and source chamber to attain the desired pressure waveform 7 9 Mean Atrial Pressure The Mean Atrial Pressure value can be adjusted by altering the fluid level in the Atrium Chamber There should be 10 20 cm of fluid above the mitral valve 7 10 Transducer Settings
30. recommendation See label below The probe factor shown in the Electronics Inc red circle translates to a setting of 4 38 on the flow meter eee EE potentiometer Reference the probe factor calibration label wee P provided with the flow probe for proper set up BLOOD FLOW Following the ViViTest software instructions for flow calibration the B 2 lt 2 software will automatically adjust create a calibration factor forthe creas flow meter signal to equal the pump dL dt If a significant drift is MO2 amp LNO yg noticed in the flow meter conversion factor the flow meter and ae 88mm probe may require calibration SERIALNO A41019 _ e Turn the POWER switch on A switch transient may cause the em ALARM indicator to illuminate Depress the ALARM indicator to reset the meter Allow ten minutes for the instrument to stabilize The green READY light should remain on when the meter is measuring flow e With the PROBE switch set to OFF Adjust the ZERO control to give a display meter a reading of zero NOTE The ZERO control is functional with or without the flow probe attached and the no signal level of the back panel MEAN and PULS outputs are set by the ZERO control The gt De with signal level should be approximately the same as the DO NOT DISCARD THIS LABEL no signal level under static flow condition krise Pc
31. shipment Inspect the system components for damage If there is evidence of damage contact the carrier initiate a damage claim and inform ViVitro Labs The SuperPump arrives pre assembled with the following parts Mounting base Linear Actuator with Cable Standard Pump Head Actuator Extension Cable SuperPump Controller USB flash drive with ViVigen software 3 5 Installing the SuperPump The SuperPump is supplied mounted to a rigid plastic base for use on a bench top Optionally the pump may be mounted directly to a structure or test apparatus using 10 32 fasteners through the mounting feet of the pump See bolt pattern layout in Section 4 9 It is recommended that the SuperPump be mounted horizontally The back side of the pump cylinder is provided with a drain however vertical mounting of the pump can result in water entering the ball screw motor causing an electrical hazard The controller should be located away from the pump to avoid any water or test fluid An extension cable is provided to allow extra separation if required It is recommended that the pump act on the test fluid through a membrane to maintain isolation between working and test fluid The piston should not be directly exposed to blood analog solution or saline Distilled water is recommended as the working fluid 3 6 Front Panel The front panel consists of 2 controls and the display The controls are rotary encoders with push switches To the left of the displa
32. system Stop SuperPump Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 107 of 118 Vi Vit ro Pulse Duplicator System User Manual Labs 6 Open pressure transducers to atmosphere using stopcocks 7 Allow fluid level to stabilize NOTE The live voltage readings should have fluctuations less than 0 005 mV before proceeding 8 Click a twice to take zero reading 9 The flow meter may experience a large drift but all other values Aortic Ventricular Atrial dL dt and pump should have a drift lt 0 01 mV upon zeroing If outside this range contact the study director 10 Open pressure transducers back to fluid 11 Proceed to collecting data promptly to minimize flow meter drift 20 10 Tuning System 1 Depending on test plan valves can be tested under a variety of operating conditions The following outlines the steps to obtain the required testing parameters 2 With pumped stopped set desired waveform and beat rate in ViViTest click apply See Figure 2 Pump Control Cycle Rate 7 a bpm Waveform FDA MF X Apply Figure 2 Setting Waveform and Beat Rate Increase amplitude on SuperPump controller to desired SV Visually inspect dL dt waveform to ensure that appropriate waveform has been selected Remove any air collected in aortic view port or atrium using overflow tube or atrial pressure port respectively Ensure overflow tube is closed before proceeding Air will accumulate in the a
33. system s hardware Connection of the system s electrical components Calibration and system setup Operator procedures for the system s daily use Operator procedures for ViViTest Software Operator procedures for ViViGen Software Optional valve and other cardiac structure mounting procedures for use within the Model Left Heart oS e NOTE The user may opt to manipulate the system to achieve _ alternate states results configurations Should the user carry this out it should be noted that the pressures and flows are kept within the limitations of the system to ensure the system is not overloaded Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 10 of 118 V V Pulse Duplicator System User Manual 2 About the Pulse Duplicator System 2 1 System Hardware The ViVitro Labs Inc Pulse Duplicator System assesses heart valve function under simulated cardiac conditions The system simulates the function of the heart s ventricle which generates pulsatile flow through a prosthetic heart valve in a ViVitro Labs Model Left Heart A Pulse Duplicator simulates physiological or other complex pressure variations which when connected to the ViViTest software via sensors provides detailed data return on prosthetic heart valve s and cardiac system performance The ViVitro Labs Pulse Duplicator System is ideal for testing a variety of prosthetic heart valves Standard and optional hardware components facilitate the mounting of mechanical st
34. the Pump Controller is properly connected to all cable connections e The power supply is auto detectable for 230 50Hz or 110 60Hz e Switch power button located on the back panel to ON Piston should immediately home to the central cylinder position e The LCD screen will display any errors and provide status of the controller e Using the waveform button located on the front panel select the desired waveform If using ViViTest the external channel should be selected Note For further pump control features please see the SuperPump AR series user manual NOTE Avoid large piston strokes that could activate the pump limit switches Note that if the push or pull limits of the pump are reached the pump will automatically reset to the home position 1 Pump Piston Transducer Calibration The pump piston linear displacement is measured for each unit The factor in mv mm is provided by ViVitro manufacturing Follow the ViViTest pump calibration step to ensure the correct Pump Calibration Factor is entered 8 2 Drive Waveform Generator Operational Check The Pulse Duplicator is operated by unique complex analog waveforms supplied by the analog output of the I O Module See the ViViTest User Manual for instructions NOTE Do not change the waveform setting while the pump is in operation Set amplitude to zero before changing the waveform The selected waveform will dictate the operation of the pump to a prescribed push pull syst
35. the Snapshot The Process Display area can be manipulated to zoom in via toggling of the tool options within the graph To Save Open and Print 1 Selecting the Snapshot button will capture the Process Display area as it is seen on the screen save window will display to enable the user to customize the file name alternately the user can opt to use the automatically assigned file name created from valve identifier information date and time NOTE The Snapshot will not open immediately but be saved to the Files directory of the software for later viewing 2 Access the file via Explorer under C Program_Files ViVitro_Labs ViViTest Files NOTE The file will be identified with JPG format The file name will be the identifier information entered for the valve and the date and time or the customized name the operator assigned 3 Open the desired Snapshot 4 Select print from the menu 10 24 Exporting CSV file data For researchers developers wishing to extract the data to create algorithms and calculations to provide specific results the option of producing a raw data csv file is available Users can access this under the Analyze tab either as raw data or by opening a results table and exporting the calculated data NOTE The output presents as many cycles as displayed within the Process Display area By clicking on the Export CSV icon you can create a CSV file once data has been accumulated The outpu
36. the Software ii acts or omissions by someone other than ViVitro Labs iii combination of the Software with products material or software not provided by ViVitro Labs or not intended for combination with the Software or iv failure by you to incorporate and use all updates to the software available from ViVitro Labs ViVitro Labs does not warrant that the Software or service will meet your requirements or that the operation of the Software will be uninterrupted or error free c Limitations on Warranties The express warranty set forth in 8 6 6 is the only warranty given by ViVitro Labs with respect to the software and Documentation furnished hereunder and any service supplied from time to time ViVitro Labs and its licensors to the maximum extent permitted by applicable law make no other warranties express implied or arising by custom or trade usage and specifically disclaim the warranties of merchantability and fitness for a particular purpose In no event may you bring any claim action or proceeding arising out of the warranty set forth in 5 1 6 more than one year after the date on which the breach of warranty occurred d Limitations on Liability Except as required under local law the liability of ViVitro Labs and its licensors whether in contract tort including negligence or otherwise arising out of or in connection with the Software or Documentation furnished hereunder and any service supplied from time to time shall not exceed the l
37. 3 Follow step by step calibration wizard NOTE The data summary presented at the end of the calibration collection sequence is used to show the adjustment k factor of the flow channels to the dL dt channel It is important to determine internal acceptance criteria for the flow channel calibration The software automatically adjusts the flow channel k factor to equal the dL dt channel Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 64 of 118 Witro Pulse Duplicator System User Manual Flow Calibration 5 of 5 This completes flow calibration Values are mean sums over entire cycles Click BACK to adjust and recalculate or FINISH to record these values Cumative Cumative Voltage Factor Flow Rate STDEV mV mV mL s mL s mV mL s Pump dL dt 1572 392 8 205 191 633 0 057 Flow Meter Confirm calibration gains fr E Back Finish NOTE To calibrate the flow transducer using the ViVitro Labs Pulse Duplicator System place an open spacer ring in the flow probe site and an occluding solid plug located in the opposite site These items are provided in the Pulse Duplicator Accessories Kit There should be no compliance between pump piston and flow probe ViViTest Open Spacer Ring and Solid Occluding Plug for Flow Calibration In cases where flow transducers are mounted in both the aortic and mitral position the dL dt signal can be ignored in favor of direct flow measurement at the valve Docum
38. 6 As Trend 73 10 19Handling Compare Results 0 2 0 0 ccccccecceceeeceseeeeceeeeeseeeeseeeesseeeesseeessaeeeseesesseeeesaeeessaees 73 Un ES eet 74 10 211 0 Module He mtalzaton 74 10 22 R NNNO RENO EE 74 10 23 Taking TN 15 10 24 Exporting CSV file Aata ccccccseccsceeccceecescecesceeeecseeesceeenceeeesceeesceeeescessscueeenseessceess 75 VISNE 76 TOZO LOG REE EEE EE EEE 76 ENEE Eege EE 76 11 Software Interface Orientation E 79 Wet Top Covo TOOD EEE EE EE EE EE 79 11 2 Process Selection and Secondary Buttons rnrrrnnnrnnnnnrnnnnnvnnnnrnnnnrennnrrnnnnrennnrennnerennnn 80 VS SONEN eger 80 11 4 Main Process Controls 82 11 5 Dala Dashboard RE 82 11 6 Process TE 83 Dr Process Or 84 ND PN 84 12 System WANS AICS eege EES 85 PIE 85 T22 Ba Fd E 86 er elle Le ee Te E e E 86 12 4 Aorta Hepnlacement 87 12 5 Ventricle Member Heplacement 87 120 PNI TN 88 13 Appendix A Supplemental Component Notes rrnnvrrnnnvrnnnnennnnvennnnennnnvennnnennnnvennnuennn 92 14 Appendix B Installing LVOT Accessories Optional rrvnnnnrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnr 93 Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 6 of 118 V V Pulse Duplicator System User Manual 15 Appendix C LVOT Simulation Assembly Optional anennnennnennnennnennnennnennnennnennner 95 16 Appendix D Components and Parts LiStS rrannrnnnernnnennnnrnnnennnnennnnnnnnennnnnnnnennnnennnunnn 96 TOA SPP NT 96 16 2 Model Ler gg EEE
39. 8 Vi Vit A O Pulse Duplicator System User Manual ADS Inc 4 3 Select Waveform Press the Menu Selector Dial Turn the Menu dial until 1 Waveform Source appears as below While the message Waveform Source is on the screen press the dial again The screen will now indicate the most recently used waveform source If the current waveform source Is desired press the dial again to escape the waveform selector If a stored waveform is desired turn the dial clockwise and press the dial when you have chosen the correct waveform Refer to Section 9 to load standard waveforms edit or create waveforms and load them onto the SuperPump Controller 4 4 Set Sync Delay Press the Menu Selector Dial Turn the menu knob until 2 Sync Pulse Delay is on the screen press the dial again The screen will now indicate the current sync delay in msec To adjust the delay turn the dial until the correct delay is displayed and then press the dial 4 5 Change the Cycle Count Press the Menu Selector Dial Turn the menu knob until 3 Totalizer is on the screen press the dial again To adjust the counter turn the dial until the correct value is displayed and then press the dial Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 19 of 118 Vi Vit A O Pulse Duplicator System User Manual ADS Inc 4 6 Pump Operation Turn the Amplitude Dial until the desired stroke volume is reached For example To stop the pum
40. 8 of 118 V V Pulse Duplicator System User Manual 9 5 New Waveform Generation New waveforms may be created using the drop down menu from the RS label in the upper left corner Select New and complete the requested data in the Create New Waveforms window Note that 1024 is the standard and expected number of Points Enter its Label name its Beat Rate and its Waveform Type Select the Save icon and name the file appropriately Select Done when completed The new waveform may now be accessed from one of the five index positions and the duty cycle and beat rate adjusted as required Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 59 of 118 MiVit Pulse Duplicator System User Manual 10 ViViTest Software Operation 1 Set up the Pulse Duplicator System refer to previous sections 2 Double click on the ViViTest icon located on your desktop 3 Select the preferred calibration file Calibration cfg is the ViVitro Labs default file with default values to run the software NOTE Good practice indicates that to verify the configuration of the system users should test a valve with known characteristics at the start of every session Once users are familiar with the waveform image associated with a standard valve inconsistent waveforms from test valves can be quickly recognized even before analyzing numeric results The ACQ data file associated with the standard valve can be loaded in either the
41. A or Model Left Heart Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 91 of 118 V V Pulse Duplicator System User Manual 13 Appendix A Supplemental Component Notes The extra compliance available with Large Volume Compliance bottle is useful in applications where aortic root or LVOT compliance is minimal This will occur in applications where low compliance conduits are being utilized This is typical when stentless aortic valves silicone rubber aortas PVL applications and LVOT models are involved in the test work If desired the air volume simulating characteristic compliance can be reduced by allowing the fluid level to rise higher in the characteristic compliance chamber and or by adding water to the supplementary bottle as shown below for the optional large supplementary compliance bottle The diagram depicts how compliance adjustment is accomplished using water to reduce the air volume Note on compliance modeling Tissue compliance is simulated in the Model Heart and VIA models by using contained air volumes These air volumes are adjustable and cover a physiologic range for simulating left ventricle aortic root and systemic arterial compliance Compliance is defined as the ratio of volume change to pressure difference as follows Compliance ME cm Dyne AP 1333 7 Where AV change in contained air volume in ml AP pressure difference mm Hg caused by volume change AV AP p P initial static
42. Analysis or Review pages in the ViViTest application In most standard test situations waveform pressure ranges should correspond to physiologic pressure ranges 10 1 Calibration Process Overview NOTE It is advised that calibration is carried out each time the software is restarted and at key intervals during use NOTE First time through perform Pump calibration FIRST Users can select any of 4 types of calibration to perform Measure sensor zero references Calibrate the flow meter and flow probe s Mitral Aortic Calibrate and zero the 3 transducer pressure sensors atrial ventricular and aortic Measure pump linear displacement Pressure Pump A complete calibration involves going through each of these Calibration Wizards which is outlined in the following sections NOTE The calibration values are read from the selected calibration file and are represented within the Session Information Panel and the Calibration Wizard These values can be altered to reflect the desired values and saved to a new calibration file via the Calibration Wizard Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 60 of 118 Vi Vi tro Pulse Duplicator System User Manual Labs 10 2 Calibration Wizard Navigation The Calibration Process is a step by step process guided by the Calibration Wizard The wizard explains each step of the process leading to measured offsets or gains that constitute the calibration values shown in the Sens
43. Ensure the glass cylinder does not bump against the cylinder rod M10 Nut and Lock Washer 12 Push the Glass Cylinder SPM042 onto the pump Ensure that the piston does not come close to the sharp edge of the glass cylinder 13 Place the Short Extrusion 08981 onto the pump The gap in the short extrusion should be in line with the longer flat section of the central stand Short Extrusion 08981 Note orientation 14 Push O Ring 235 SPM072 into the groove on the outside face of End Cap 08975 15 Push O Ring 335 10084 into the groove on the inside face of End Cap 08975 Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 90 of 118 Pulse Duplicator System User Manual Long flat section Inside Face 16 Fasten the End Cap 08975 onto the pump head with four 7 20 x 4 5 SHCS 08980 Take care not to chip the edge of the glass with the aluminum parts Tighten the fasteners gradually to prevent uneven stress on the glass cylinder Compress the sides of the Short Extrusion 08981 while tightening so that the sides sit flush with the end cap faces Outside Face Ya 20 x 4 5 17 Check for damage on O Ring 09534 into the recess of the SuperPump Piston Cap 09533 18 Fasten the SuperPump Piston Cap 09533 to the SuperPump Piston with three 6 32 x SHCS HCM079 Loctite is not required The SuperPump is now ready for installation of the Viscoelastic Impedance Adaptor VI
44. Four ports with stopcocks are provided for the insertion of pressure transducers to measure Aortic Aortic outflow tract Ventricle and Atrial pressures Instruction e Insert the pressure transducers directly into the stopcocks at the CLOSE OPEN pressure measuring ports e Care should be taken to remove air bubbles in the fluid line from ar pressure transducers by flushing the line using a syringe Ca ge distilled water is recommended Attach the syringe to the outer l E luer fitting open inner and outer fitting and slowly pull fluid through transducer Repeat until all bubbles are removed and away from transducer sensor e Apply atmospheric pressure to the pressure transducers by turning the appropriate stopcocks to the closed position this allows the transducer to measure air atmospheric pressure NOTE Excessive tightening of the Luer lock cap should be avoided Pressure transducers may be damaged by over pressure This can occur if a finger occludes the transducer pressure port during transducer flushing RAPID STOPCOCK CLOSURE may also produce excess pressure Please contact ViVitro Labs Inc regarding use of other pressure transducers with the ViVitro Labs Inc Model AM9991 amplifiers e g Millar catheter tip MPC 500 NOTE Atmospheric pressure is useful as a zero pressure reference The pressure on the transducer sensing element will be atmospheric plus or minus the static head This includes fluid in the stopcock and in
45. Pressures and Flows Legend to highlight or hide traces 10 14 Derived Flow Measurements Total System Flow Flow Meter Flow Un instrumented Valve Flow This derived flow will only be meaningful if the data was acquired using the ViVitro Labs Pulse Duplicator System with no compliance between pump piston and the model s ventricle In this case the derived flow should correspond to the flow in the side without a flow probe either aortic or mitral 10 15 Useful Icons Refresh Use the refresh button in the upper right corner of the graph to clear any artifacts from the graph should it become corrupted To change pressure units for the values shown in the Data Dashboard select the mmHg KPa toggle at the upper right corner Static head pressure compensation is one of the parameters measured during the sensor calibration process Users can enable or disable these 3 pressure sensor compensation values to the data algorithms by selecting the Static Head compensation checkbox in the Sensor Calibrations panel Once satisfied with the results save the Analysis means for the 10 waveforms to an ANA file by selecting the Save button Users can review the results calculated for each of the 10 waveforms in detail by reviewing a data table showing all 10 waveforms and the cumulative means Select the Data Table button in the title bar to bring up the data table Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 71 of 118 iLO Pul
46. Pump includes pump head and motor pre installed SuperPump Motor power supply cable SuperPump Amplifier SuperPump Amplifier power supply cable Cooling fan SuperPump mounting shelf Model Left Heart Ventricle chamber Aortic chamber Atrium chamber Aortic standoff Accessories kit includes 2 compliance chambers 1 peripheral resistance controller and 4 colour coded silicone tubes Accessories table Mechanical disc valve Data Acquisition System I O Module Computer and associated components ViViTest Software package USB cable Short BNC cables Long BNC cables Flow Measuring Flow Measuring controller Flow probe Flow probe cable kit includes cable to flow probe and ground Optional System Components Heat Exchanger 1 1 2 1 1 M Heat bath including pump and controller box Heat Exchanger Long silicone tubes Short silicone tube Power supply cable anometer Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 96 of 118 3 Pulse Duplicator System User Manual 17 Appendix E Glossary Test Fluid Fluid used within the chambers pump and pump head Aortic Chamber Provides in conjunction with the Aortic Root Compliance Chamber and Aortic Compliance chamber characteristic resistance which simulates the left aortic functions of the heart Atrium Chamber Provides characteristic resistance which simulates the left atrium functions of the heart Aortic Root Provides in conjunction with the
47. The Data Dashboard area shows the data for both the aortic and mitral parts of the heart cycle NOTE Once users select the target valve on the right the opposite control valve data is de emphasized PN Snapshot At any point users can select the Snapshot button in the Top Menu Bar to capture a JPG image of the graph to record particular features of valve behaviour 10 10 Re zero Sensors Re zero Sensors At any time during a test users have the option of returning the system to a quiescent state and collecting sensor zeros This is helpful in confirming sensor accuracy and drift 10 11 Analyze Process Once one or more 10 cycle ACQ files have been saved users can begin to perform a more comprehensive analysis of the valve cycle waveforms by selecting the Analyze tab an open file dialog allows users to select a valve trial from the list of ACQ files contained in the C Program Files ViVitro Labs ViViTest Files folder on the right The left side selector buttons allow users to select one several or all of the 10 acquisition trial waveforms for graphing NOTE When the All Waveforms cycles button is selected statistics shown on the graph and in the lower results panels apply to the first waveform by default To see the results of another waveform simply click once on the waveform number you wish to see When some but not all of the waveforms are selected statistics apply to the most recent waveform selected
48. V V Li Pulse Duplicator System User Manual Optional hardware Heat Exchanger and Heat Bath Large Compliance Chamber LVOT accessories Transfemoral and Transapical Access Device Digital Manometer The following steps detail procedures for assembling the main components outlined above in the order that they should be installed for a complete unit 6 2 SuperPump The SuperPump arrives pre assembled with the following parts e Base Plate e Linear Actuator Cylinder e Standard Pump Head WARNING Itis recommended that the SuperPump be positioned with its longest dimension horizontal 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 to occur NOTE The pump head is made from an electrical non conductor In applications where an electromagnetic flow transducer is used this will isolate the path to ground for the transducer from the ground path for the motor This should improve the signal to noise ratio of the flow signal Locate the SuperPump on a fixed structure i e a table or frame suitable to accommodate the weight and dimensions of the entire system once put together The pump head of the SuperPump should extend over the edge of the bench to provide clearance for the ventricle drain assembly 6 3 Attaching the VIA and the Ventricle Chamber Fasten the VIA directly to the SuperPump using 3x 8 32 x 1 screws and flat washer
49. ach valve in test plan Once all valves have been completed proceed to Section 20 15 to ensure data quality Ensure data is being backed up as appropriate Once testing is complete have study director sign off Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 109 of 118 Vi Vit roO Pulse Duplicator System User Manual Labs 20 12 Moving Markers 1 Once data has been captured the analyze tab will need to be used to extract the relevant flow parameters The procedure differs whether an aortic or mitral valve is being tested Aortic Valve Testing 2 Clicking will take you to the screen to analyze collected data The software will automatically open the most recently collected data file to open a different file use the navigator on the right side of the screen 3 Note When analyzing data in ViViTest channels can be turned on off by clicking on the desired channel in the legend below the pressure flow curve display This can make it easier to locate crossovers for maker setting d Set AO Positive Pressure by setting ao ve1 to the point where TRANSAORTIC signal first rises above zero and ao ve2 to where it crosses back over zero see Figure 3 In other words move ao ve1 to the first point at which the ventricular pressure is above the aortic pressure Set ao ve2 to the last point at which the ventricular pressure is above the aortic pressure Analysis for rial Figure 3 Example of AO Pos
50. an vent is not blocked e Always connect the power supply to a 3 prong grounded AC outlet rated 4A 110 240 V using the AC power cord provided with the SuperPump Do not use an adapter to an ungrounded outlet Before plugging the instrument in be sure that the correct fuses are installed See section 3 9 e Electrical devices pose the risk of electric shock To reduce the risk of shock do not open any covers that are fastened with screws e While SuperPump is designed to withstand spills on its exterior surface do not allow fluids to enter the interior of the instrument In the event of such a spill disconnect the power cable before cleaning up e Do not operate SuperPump in extreme humidity or in conditions that can create condensation Protect the instrument against dust and moisture and avoid physical shock and strong forces e Clean the controller and pump exterior with a dry cloth Disconnect power before cleaning e Use caution when moving the controller and or pump Disconnect power and pump cable before moving the system to a new location e Do not use the SuperPump system if there is evidence of physical damage or if the system has been dropped or subject to impact e Do not attempt to service the product beyond what has been described in this manual All other servicing should be referred to qualified service personnel 1 2 About this Manual This document describes the Pulse Duplicator System s procedures for Assembly of the
51. anual 3 About the AR Series SuperPump 3 1 System Hardware The Advanced Research series SuperPump System made by ViVitro Labs Inc consists of a digital amplifier with stroke volume display and preprogrammed waveforms driving a piston in cylinder pump The pump piston is located by a ball screw servo motor encoder unit driven by a motor controller which compares actual position against the desired position defined by the input waveform The precision of the ball screw and the resolution of the encoder ensure accurate positioning of the piston resulting in the desired pulsatile flow The controller can be used stand alone by selecting one of the built in waveforms or an external signal can be input ViVigen software is included with the pump to allow the generation of custom waveforms which can then be uploaded to the controller via the built in USB port The SuperPump is designed for use as part of the ViVitro Pulse Duplicator and includes the required inputs and outputs for this These same I O including analog outputs for position dL dt flow and the sync pulse make the SuperPump adaptable to any custom test apparatus The ViVitro Labs AR series SuperPump is ideal for testing a variety of cardiovascular devices 3 2 Features The SuperPump AR series from ViVitro Labs Inc features include e Digital precision control of a pump in cylinder designed linear actuator used to generate physiological flows Stand alone capability with five 5 prepr
52. aortic pressure ViVitro Labs Inc 2014 Page 103 of 118 Vivi MI Positive Pressure Test Fluid VIA Companion Valve Sample Run Nominal Conditions Pulse Duplicator System User Manual The part of a cardiac cycle in which AP across the mitral valve is positive atrial pressure greater than ventricular pressure The fluid that will come into contact with a sample in the Pulse Duplicator Examples Saline Blood Analog Bovine Blood etc Viscoelastic Impedance Adapter The valve located in the opposite position of the valve being tested For example if an aortic valve is being tested the valve in the mitral position is the companion valve By default the companion valve is the ViVitro Spring Loaded Disk Valve Note When possible the companion valve in the mitral test position will be at least one size larger than the valve being tested in the aortic test position Could be valve etc If the test specimen requires a holder to interface with the testing equipment the entire assembly will be considered a sample The measurement recording and subsequent averaging of required parameters for 10 cardiac cycles Test parameters used for acceptance criteria listed in ISO 5840 Consisting of 5 LPM at a beat rate of 70 minute and stroke volume of 75 mL stroke with a 35 systolic duration 20 2 Summary Test ref ISO 5840 3 Annex N The heart valves undergoing testing are mounted in the active test position aortic mitral
53. apply to the design of rubber rings for mounting mechanical or tissue valves with or without sewing rings Molding jig components for valves are shown coloured in the following illustration The jig components can be separated and adjusted by loosening bolt A and thumb screws C amp D The custom pedestal Light GREY is attached to the base PURPLE with a bolt A The pedestal can be the actual valve or a replica of the outer dimensions to which the rubber ring seals It can be made of Delrin which has good mold release ability When a valve or valve Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 23 of 118 V V Pulse Duplicator System User Manual component is used as a mold a thin layer of Vaseline coating on the component may facilitate mold release after vulcanization Vaseline can be washed off using soap and water after the rubber ring cures In general to help minimize flow turbulence a tapered transition should be made between the outside diameter of the rod and the inside diameter of the device inlet orifice For tissue valves it is likely that the tissue will be damaged in the molding process and should therefore be cut away before molding A tissue less valve stent having all component parts except issue can facilitate molding of complex shapes If porous fabric materials are to interface with the silicone rubber a thin layer of mold release e g Vaseline or wax should be applied before molding Experimental device
54. assembly complete install assembly into the Pulse Duplicator System aortic assembly housing and proceed with function testing Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 94 of 118 ckt Pulse Duplicator System User Manual 15 Appendix C LVOT Simulation Assembly Optional This sketch depicts a mounting scheme using silicone tubing to simulate a variety of LVOT sizes Parts A66 A68 and A69 are custom fitted to accommodate silicone tubes with relaxed tube ID s of 13 16 19 22 25 and 28 mm The 28 mm tube may be expandable up to about 50 mm OD and cover intermediate sizes as indicated k a Se 825 Ed RVOT outflow pressure port MAXIMUM INTERNAL DIAMETER 28 mm 9 43 0 13 48 8 0 3 Ei TF TF ral re BR E ee E RVOT inflow pressure port USING A SYRINGE FROM THIS PORT SUCTION REMOVAL OF AIR or WATER SURROUNDING THE SILICONE TUBE RVOT MODEL ALLOWS DESIRED DIAMETER TO BE OBTAINED USING THE UNEXPANDED 28mm TUBE SIZE ALL INTERMEDIATE SIZES 28 50 mm Dia COULD LIKELY BE OBTAINED Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 95 of 118 V V Pulse Duplicator System User Manual 16 16 1 zech sesch sesch sesch sesch wesch 16 2 zech wesch sesch be br N 16 3 O OUO sch 16 4 16 5 Appendix D Components and Parts Lists SuperPump Super
55. ays pump linear transducer calibration values as input in the Wizard and represented within the CFG file 11 4 Main Process Controls Pulse Duplicator System User Manual Pump Displacement Calibration Linear Transducer Calibration E SECH 140 381 ee 141 258 Transducer Displacement mm Transducer Calibration m mm Pump Piston area cn nd Pump Spacer value mm Fr Control buttons which modify or add attributes to the Process Display area Calibrate Acquire my Ventricular Atrial Pressure Pump dL dT Finished Flow Sensor Pump Stroke Pump All Channels Save 10 Cycles Re zero Sensors 11 5 Data Dashboard Aortic Pressures Yolumes EICH 100 0 ak Max ETA mmHg Mean mmHg Stroke 02 D i Me Guill oe Mer SCH 2 1 C Date BPM Stroke mi c o 53 Wa Waveform01 Waveform 02 Waveform 03 Waveform 04 Waveform 05 Waveform 06 Waveform 07 Waveform 08 Waveform 09 Waveform 10 All Waveforms ZE E E E E E E E E E gt Waveform 01 Energy Waveform 02 DET Waveform 03 Regurge Waveform 04 Waveform 05 Waveform 06 Waveform 07 Waveform 08 Waveform 09 ZE E E E E E E E E Waveform 10 N Avg Waveform N All Waveforms Units Units Ventricular Pressures EDA Interval DELA 93 9 ae Mean mmHg Min EEE mmHg see oo ar e Information relating to Aortic or Mitral Valve measurements e Provides non editable summary data for both the aortic and m
56. chamber and the other on the VIA e elevate the whole system at the ventricle chamber by approximately 30 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 30 of 118 M Vitro Pulse Duplicator System User Manual e debubble remove the air in the chamber e return to horizontal position when debubbling is completed Adjust the fluid volume of the ventricle chamber so that the ventricle membrane is in a relaxed state by attaching a syringe to the stopcock on the ventricle chamber open the stopcock closing the stopcocks on the VIA if installed add fluid to the ventricle chamber ensuring the ventricle membrane is in a relaxed state NOTE The fluid in the ventricle chamber can remain but should be replaced periodically lt 2 months If the system is used infrequently drain fluid from the chamber and allow it to dry 6 6 Accessories Table Installation An accessories table has been supplied in the model left heart crate to accommodate the peripheral resistance and supplementary compliances Mount the accessories table to the provided flanges on the SuperPump using the two 10 32 x 1 red thumb screws provided The two threaded holes in the edge of the table for mounting the optional heat exchanger should be at the front left of the SuperPump Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 31 of 118 Vi Vit O Pulse Duplicator System User Manual ADS Inc 6 7 Atrium Chamber Installation NOTE I
57. cts in material and workmanship under normal use and service in a suitable environment for the period of one year after delivery Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 117 of 118 V V Pulse Duplicator System User Manual 22 Appendix J Wetted Materials The Pulse Duplicator consists of the following materials that are in contact with the test fluid Acrylic Polycarbonate Buna N Teflon ABS Platinum 316 SS PVC Silicone Acetal Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 118 of 118
58. d to the Aortic Root Compliance Chamber by way of the luer fitting connected to the tube at the compliance chamber NOTE If fluid enters the aortic root tube it will alter the Aortic Pressure waveform This will be noticed by a dip in the Aortic Pressure waveform after the Ventricle Pressure drops Result e Approximate air volumes will be Aortic Root Chamber 35 ml plus Aortic Root Compliance Chamber incl hose 615 ml Totaling 640 ml If desired this volume and hence Aortic Root Compliance can be reduced by adding water to the Aortic Root Compliance Chamber to reduce the air volume Aortic Compliance The fluid in the Aortic Chamber should be allowed to rise approximately 2 5 cm 1 Using a syringe apply or release air as needed to the Aortic Compliance Chamber by way of luer fitting connected to the tube at the compliance chamber Note During collection of low cardiac outputs e g 2 LPM C O it may be necessary to clamp the Aortic Compliance Chamber hose to reduce the compliance see comments in Pressure Waveform Adjustment section Result e Approximate air volumes will be Aortic Chamber 300ml plus Aortic Root Compliance Chamber incl hose 350ml Totaling 650ml If desired this volume and hence Aortic Root Compliance can be reduced by adding water to the Aortic Root Compliance Chamber to reduce the air volume Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 44 of 118 iLO Pulse Duplicator System User Manual
59. device during forward flow conditions 5 When the rubber is cured dismantle the molding jig and remove the rubber ring Remove the upper ring GREEN from the middle ring YELLOW Two notches on the upper ring GREEN allow insertion of a blade type screw driver which can help pry the two rings apart Push the middle ring YELLOW down over the base PURPLE Peel and stretch the rubber ring off the device light GREY The rubber ring should be trimmed of any excess rubber using small scissors Trimming should be done carefully to prevent compromising the seal of the ring eS 5 4 Preparation of RTV silicon rubber Optional accessories recommended for molding silicone rubber are given below These items may be obtained from the indicated suppliers e 35 ml stroke hand operated vacuum pump capable of generating up to 25 inches of mercury vacuum P 79301 20 Cole Parmer Inc e 365 ml Plexiglas vacuum chamber 1 4 inch I D tubing VC9991 e air powered dispenser controller gas pressure input 80 100 PSIG gas pressure output 0 100 PSIG 800V EFD Inc e 30 ml Barrel reservoir pistons 5112CP B EFD Inc NOTE A standard hand operated 35 ml syringe may also be used rather than an air powered dispenser and barrel reservoir piston combination however considerable force of hand is necessary to inject the rubber mixture The tapered tip e g 5116TT B should be attached to the syringe before dispensing the rubber
60. e clamp drain after system is drained Fluid remaining in the left atrium reservoir can be drained by temporarily disconnecting the green colour coded hose connected to the left atrium port Remaining test fluid in the aortic root above the aortic valve can be removed by syringe through a pressure port stopcock Replacing frequency Zone 1 Will be replaced by natural course due to the changing of prosthetic structures on a regular basis Zone 2 Replace every 2 months Zone 3 Replace every 2 months Instructions Zone 1 1 Ensure the system is turned off including the flow probe s 2 Place bucket under Ventricle Chamber 3 Open drain valve situated beneath the chamber 4 Allow to completely empty NOTE Ideally you would allow it to completely dry before placing further fluids in the system Instructions Zone 2 Ensure the system is turned off including the flow probe s Place bucket under Ventricle Chamber Open luer drain port on bottom of Ventricle Chamber Tip the entire system to 30 with the motor at the higher end This will aid the draining of the VIA and pump head 5 Return to horizontal position NOTE Ideally you would allow it to completely dry before placing further fluids in the system Instructions Zone 3 Ensure the system is turned off including the flow probe s Drain as per the Heat Bath manufacturers recommendations ai ad en 12 3 Cleaning Acrylic Fluid The other acrylic plastic parts can be clean
61. e eee ee ee 113 OED Remove Eege 113 20 15Data Quality Assurance rrrrannrrrnnnnrrrnnnrrnrnnnrnrnnnnrnrnnnrnnrannennnnnrenrnnnsnnnnsennnnssennnnssennnn 114 E Eege RT NN a MN 114 20 17 Maintenance EN 114 21 Appendix I End User License Agreement nrrnnnnnnnunnnnvnnnuvnnnnvnnnvnnnnnnnnvennnvnnnnnnnnvennurr 115 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 7 of 118 V V Pulse Duplicator System User Manual 2 SNE NE 115 21 2 Ownership of the Software Restrictions on COPYING ccccseeeseeeeeeeeeeeeeeeesaeeesaees 115 21 3 Other Restrictions ON USE ercer aeiaai iaa aaa aa E aiaa Aa 115 TEN 116 21 5 Responsibilty for Selection and Use of Gotbware 116 21 6 Limited Warranty Exceptions amp UDscamers 116 21 7 European Software Directive 117 Zio TENNE 117 21 9 Canadian Sales rarrrnnnrrnrnnrrrnnnrnrnnenrnnnrnnnnrrransennnnernansnnnnnennnsennnnnennnsennnssennnnennnssennnsen 117 22 Appendix J Wetted Materials nrnnnnnrnnnvrnnnnevnnnvennnnennnnvennnnevnnnvennnnennnnvennnnevnnnvnnnnuennn 118 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 8 of 118 V V Pulse Duplicator System User Manual 1 About ViVitro Labs ViVitro Labs Inc offers industry leading cardiovascular test equipment and related laboratory testing services Hundreds of organizations in over 39 countries for 30 years have trusted ViVitro s expertise accuracy and quality for their cardiovascular device testing As the develope
62. e to desired operating conditions Fill in session information in ViViTest Trial Title test plan number TP xx xx Trial Number 00 optional Aortic Valve valve ID in aortic position Mitral Valve valve ID in mitral position Operator ID your name optional Ventricle Vol 150 00 ml optional Fluid Density 1 01 g ml if saline is test fluid or as specified in test plan Fluid Temp 37 C or as specified in test plan optional Flow Probe Site set to location to test valve Target Valve set to location of test valve Record the following in lab note book if not already done Test fluid used and relevant parameters if specified in the test plan Suggested viscosity and density Temperature of test fluid VIA compliance volume Companion valve used Ensure test fluid is at desired temperature as specified in the test plan with calibrated thermometer Tune system to first desired parameter as per Section 20 10 i Capture 10 Cycles optional Follow Section 20 12 for aortic or mitral valve Repeat steps 20 for each test condition in the test plan If required by the test plan record high speed video of each valve at nominal conditions Once all conditions are complete proceed to Section 20 14 to drain the system and remove test valve Have the study director sign off after the first data collection Notify QA that a testing audit can be conducted Repeat above for e
63. ed using a soft cotton cloth with detergent and water If required acrylic parts can also be sterilized by using glutaraldehyde or a dilute hydrogen peroxide solution Keep these solutions away from the flow probe electrodes Alcohol abrasives and solvents should never be allowed to come into contact with the acrylic components of the Model Heart Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 86 of 118 V V Pulse Duplicator System User Manual 12 4 Aorta Replacement CAUTION THE GLASS AORTA IS FRAGILE HANDLE WITH CARE DO NOT APPLY UNDUE STRESS 1 Remove the original aorta exit tube assembly from the load assembly o remove two 2 56 bolts on the clamp retaining the catheter to the side of the aorta exit tube o remove four 6 32 x 3 8 inch bolts to detach the white plastic plate at the entrance of the glass aorta o loosen the two 6 32 bolts and rotate the washers near the exit end of the glass aorta to allow aorta assembly removal o push the exit end of the plastic aorta exit tube to remove glass aorta and exit tube assembly 2 Remove remnants of the original aorta and silicone sealant from the exit tube 3 Attach three 2 cm strips of adhesive tape equally spaced on the inside surface of the new aorta exit with 1 cm of tape projecting above the end 4 Hold the aorta exit tube above the glass aorta so that the pressure port is aligned with a sinus edge 5 Mate and center the exit tube counter bore with the aorta and t
64. ed using trapezoidal rule and dt 1 sample rate Forward Energy FE mj F2 FE Conversion factor F1 Closing Energy CE mj F3 CE Conversion factor F2 Leakage Energy LE mj F4 LE Conversion factor F3 Total Energy mj Forward Energy Closing Energy Leakage Energy Document No 17473 V1 3 ViVitro Labs Inc 2014 ml AP flow 7 dt ml AP flow frr dt ml AP flow eg dt Page 102 of 118 Vivi Pulse Duplicator System User Manual 20 Appendix H Step By Step Guide 20 1 Symbol Feasibility test Regulatory test BPM SV CO FV Regurgitation Transvalvular Regurgitant Fraction Total Regurgitant Fraction EOA EOA ne ae 51 6 2d p Where Definitions Definition A test conducted for research and development purposes only This type of test is not intended for submission to a regulatory body A test conducted with the intent of submission to a regulatory body i e FDA CE The test should fully comply with all applicable regulations Frequency of operation expressed in terms of beats per minute Stroke Volume is the amount of fluid ejected from the left ventricle during each beat Value is calculated from piston area and stroke length Cardiac Output in liters per minute LPM calculated as product of SV and HR Forward Flow Volume is the volume mL of fluid passing through the valve during the forward flow phase of the cycle To
65. ement the Software or the license granted by this Agreement You may not modify or make works derivative of the Software and you may not analyze for purposes competitive to ViViTest reverse engineer decompile disassemble or otherwise attempt to discover the Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 115 0f 118 V V Pulse Duplicator System User Manual source code of the Software except in accordance with the following if applicable as it contains trade secrets of ViVitro Labs and its licensors 21 4 Term The license granted herein will continue until it is terminated in accordance with this term ViVitro Labs may terminate the license granted herein immediately upon written notice to you i for justified cause including without limitation breach of any provision of this Agreement or ii if you breach any provision of this Agreement and fail to cure such breach within fifteen 15 days of notice thereof Upon the termination of the license you will promptly return to ViVitro Labs or destroy all copies of the Software and Documentation covered by the license as instructed by ViVitro Labs 21 5 Responsibilty for Selection and Use of Software You are responsible for the supervision management and control of the use of the Software and output of the Software including but not limited to 1 selection of the Software to achieve your intended results 2 determining the appropriate uses of the Software and the output of the Sof
66. ent No 17473 V1 3 ViVitro Labs Inc 2014 Page 65 of 118 Vi Vit O Pulse Duplicator System User Manual ADS Inc 10 5 Pressure Calibration Calibrating and Zeroing the Sensors Pressure Calibration of the aortic ventricle and atrial pressure sensors has two parts e a2 point pressure calibration then e ameasurement of static pressure head differences between the 3 pressure transducers NOTE 2 point pressure calibration pressures must be applied to all 3 transducers simultaneously NOTE The low and high pressures should be chosen to span the expected working range of the transducers e g 0 to 200 mmHg NOTE Usually the 3 transducers are mounted on a manifold and first exposed to the atmosphere to establish the lower end of the range Then a large syringe and a digital manometer are used to apply the upper range pressure The software measures the ADC voltage at each of these limits and uses these as a 2 point slope in calculating the calibration gain Pressure Calibration gt Lower Pressure Reading 3 of 12 Attach the 3 pressure transducers to a manifold so will all be at the same pressure Open the manifold to the atmosphere and then click PROCEED to record atmospheric reference pressure Read Atmospheric Pressure TT EEE Proceed Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 66 of 118 1Vitro Pulse Duplicator System User Manual oa i Pressure Calibration gt Static Head Confirmation 11 of 11
67. ented and stentless bioprostheses percutaneous devices The system is also suitable for other related cardiovascular purposes such as measurements of root compliance in conjunction with video recording or average coronary flow 2 2 Hardware Features The Pulse Duplicator System from ViVitro Labs Inc features include e Assessment of heart valve performance and function under simulated cardiac conditions e View and monitor heart valves under simulated conditions via o transparent parts and view ports to observe and video record valve function and adjacent flow fields o aids in flow visualization studies o thin acrylic windows permit ultrasound transmission for interrogation of flow fields in aortic and mitral regions o transducer sites to measure wall pressures in the atrium ventricle aortic outflow tract downstream of the aortic valve and upstream of the aortic and mitral valves e Control pulsatile fluid flows to simulate various cardiac flow conditions to include arrhythmia normal hypo and hypertensive states at various cardiac outputs and beat rates e Peripheral resistance and supplementary characteristic compliances to simulate cardiovascular character and resistance e Control create download and playback cardiac waveforms at various physiological states and lower frequencies e Quality data acquisition which meets verification and testing in accordance with ISO 13485 requirements and aids in the collection of data t
68. er e Flow Probe e PHONO to BNC Cable Before installing the flow probe s an initial operation check of the flow measurement system should be performed as follows NOTE This should be done for each flow probe and its accompanying flow meter 1 Check that the voltage switch on the back panel of the unit is set for your mains supply 115 or 230 VAC If it must be switched ensure the correct fuses are installed in the meter as per the instructions on the rear of the unit If it is necessary to change the power plug style then the following conductor colours apply black phase ieee 2 Check POWER OFF down and PROBE switch OFF 3 Plug the power cord into the mains supply NOTE The Flow meter must be properly grounded to the probe site 4 Connect PULS output on the back panel to the INPUT CH 4 on the I O Module 5 Place the flow probe and ground lead into a non metallic container filled with a conductive fluid such as saline It does not function in air or pure water 6 Insert the ground lead cable into the flow meter ground jack on the front panel of the meter 7 Connect the 8 pin probe plug to the flow meter jack with the correct registration as indicated by the missing pin 8 Set the MEAN switch to HI 9 Set the outer dial on the RANGE switch to give a PFX probe factor multiplier of 1 10 The Hz RESPONSE and PROBE FACTOR controls should be left as set during ViVitro Labs Inc calibration as shown on the calibration sheet 11
69. erlaid gradient bars at the top of graph mark pressure intervals bars at the bottom of the graph mark flow intervals NOTE Markers must be in correct logical sequence from left to right If this is not the case analysis will stop and an error bar will appear below the graph Markers must then be moved to be in sequential order Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 70 of 118 MiVit Pulse Duplicator System User Manual The end of the Closing Flow interval may need adjustment particularly if the flow is non zero at these points There may be a precursor to positive flow in which case the start of forward flow could be advanced in time to avoid negative values of mean transvalve pressure during the forward flow interval Users should check the crossover placements for each of the 10 waveforms that makeup the analysis data NOTE When All Waveforms is selected moving markers will affect all 10 waveforms 10 13 Producing Data Output Once analysis and adjustment of 10 cycles of data has been completed means and standard deviations for the 10 cycles can be output as an ANA file CSV file data table or printed report by selecting the Save Export CSV Data Table or Print icons see the Appendices for further instruction As in the Acquisition Process graph traces may be hidden by selecting their trace button below the graph Users can define the graph s level of complexity by selecting trace names in the
70. ero If the meter is off scale check for improper grounding or air bubbles in the probe lumen which can be removed using a cotton swab Alternate and while adjusting Balance for least difference Move the probe so that an oscillatory flow of saline moves through the probe lumen caused by moving the hand or implement in the fluid manually The display meter should show an oscillatory signal above and below zero The back panel PULS output should also follow this signal This may be verified on a flow monitor or via the ViViTest software Turn the PROBE switch OFF when flow is not being monitored Successful completion of the above steps indicates a functioning flow meter system and mounting of the flow probe into the Pulse Duplicator System can proceed Once mounted in Pulse Duplicator System step 5 and 17 are not applicable Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 35 of 118 Vi Vi tro Pulse Duplicator System User Manual 6 10 Labs Installation of Flow Probes There are two positions on the Pulse Duplicator System where electromagnetic probes may be installed in the place of substitute probes in the aortic site and the mitral site AORTIG MITRAL When a single probe flow meter is used the displacement of the pump is differentiated over time to obtain the total flow into the system and then the measured flow from the site with the sensor is subtracted from this number to obtain t
71. ew valid checksum calculated 10 8 Acquisition Process The Acquisition Process allows operators to capture 10 successive waveforms cycles for the valve being tested for subsequent analysis by the Analysis Process The Process Display area displays pressures flow transvalve pressures and pump stroke volume The Process Controls modify the pressure display The Support Information and Data Dashboard areas have a number of data boxes showing critical metrics such as cardiac output and pertinent pressures volumes and flows NOTE During the Live Acquisition Phase voltages measured by the I O Module are rendered as 6 pressure and flow traces in the Process Display area every 2 5 seconds each trace corresponds to an A D channel Users can hide unwanted traces by selecting one or more of the selector buttons along the left side Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 68 of 118 ckt O Pulse Duplicator System User Manual 10 9 Standard Valve Verification Adjust the Pulse Duplicator System until the quality of the waveforms shown in the graph panel is considered valid Complete the fields in the Session Information panel It is particularly important that users indicate the location of the Flow sensor so that flow algorithms operate properly NOTE Trial date is filled in automatically 1 Capture 10 Cycles Click the button to capture 10 consecutive valve pulse cycles Save the captured data to an ACQ file
72. f you wish to install a mitral flow meter electromagnetic probe you may wish to do this prior to installing the Atrium Chamber see Installing the mitral flow probe 1 Mount the atrium base plate assembly on to the four long stainless steel screw posits situated on the mitral valve side of the mounting block 2 Tighten the red thumb screws on the assembly to provide a seal around the valve ring Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 32 of 118 Vi Vit ro Pulse Duplicator System User Manual Labs 6 8 Aortic Assembly Installation NOTE If you wish to install an aortic flow meter electromagnetic probe you may wish to do this prior to installing the Aortic Chamber see Installing the aortic flow probe Mount the aortic chamber on the aortic standoff over the ventricular outflow tract flange over the aortic valve Tighten the red headed thumbscrews NOTE When positioned correctly the side of the aortic assembly with the three ports colour coded RED YELLOW and BLUE should be facing towards the accessories table NOTE The aorta viewing tube and window assembly is adjustable and is locked into position using three bolts The viewing tube window should never be closer than 20 mm from the end of the aorta outlet tube Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 33 of 118 Vi Vi tro Pulse Duplicator System User Manual Labs 6 9 Flow Probe s Initial Operational Check Componenis e Flow Met
73. ffset is intended for recreating a particular wave shape The peak to peak limits with offset must still remain within 5 0 Vpp relative to ground e Noise and Distortion both noise and distortion will affect the accuracy of the pump movement therefore the signal source should be clean with THD N total harmonic distortion and noise below 5 Note the maximum velocity of the piston is limited to approximately 60mm sec As amplitude and frequency are increased the velocity will also increase If the pump cannot match the desired waveform a pump error will result In this case either the maximum slope of the waveform must be reduced or the frequency or amplitude must be reduced Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 17 of 118 Vi Vi tro Pulse Duplicator System User Manual Labs 4 2 Initialize System Turn on the power switch on the back of the Controller The screen on the front of the Controller will light up and indicate that it is Initializing It will then automatically begin a Homing Pump sequence gt Firmware Programming F TN ap A iR be HIERS 1e Menu Amplitude Selector Dial After automatically Homing Pump the screen should appear as below The most recently used waveform source will appear in the Current Waveform section Current Amplitude Current Stroke Volume kb Amplitude Current Sync Output Waveform Delay Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 18 of 11
74. he control NOTE All files saved from the software are saved to the Files folder of the software directory e g C Program Files ViVitro Labs ViViTest Files 11 2 Process Selection and Secondary Buttons These tabs transfer you to the various components of the software These are e Calibration Process Acquisition Process Analysis Process Compare Process and Acquisition Review 11 3 Support Information Area e Demographic statistics process table data and context help in collapsible panels at screen right e Displays editable and non editable information relating to the Process Display area A Collapses the selected data area F Opens the selected data area Session Information Fag cee Set up key valve identifier information for each time a new oO a e valve is being tested Ensure that the correct flow probe gg LE site is selected to gain correct readings Data entered Di within this area will be used to create automated file Mitral Valve TEST a TEA 15000 MN names Fluid Density g ml ree 3710 ke Flow Probe Site Target Valve Sensor Calibrations Sensor Calibrations Calibrahon31 cfg Represents the collected calibration values within the Se ee selected calibration file Vente 5715y 0378 0000 49789 Enable disable Static Head compensation to alter GE pe readings as desired ow v 0 000 8 000 Pump UU Static Head compensation Eg Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 80 of 118 MT O La bs Inc
75. he flow in the site without a sensor In every case a ground connection between the flow meter and the probe site is necessary SYNCH on the back panel of the flow meter is used only when two flow meters are connected 6 11 Installing the Aortic Flow Probe The aortic probe is located between the ventricle chamber and the aortic chamber on the aortic standoff 1 2 Remove the aortic assembly loosen thumb screws and lift off tapered screw posts Unscrew the four tapered screw posts to remove the white mounting on the aortic standoff This will reveal a further 4 screws to remove the remaining structure Remove the four screws to unclamp the substitute flow transducer white Delrin spacer Remove substitute flow probe Insert electromagnetic flow probe using the supplied flow channel alignment jig to assist in centering the flow probe between the aortic housing clamp ventricular outflow tract and valve mounting base Take care to align the flats on the alignment jig with the probe electrodes to prevent marring the electrodes Replace and evenly tighten the four bolts Do not use excessive torque Replace and adjust the four tapered studs so that when the thumbscrews are being tightened onto the tapered surface of these studs the mating flanges pull together and provide a seal around the silicone ring Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 36 of 118 Vi Vi tro Pulse Duplicator System User Manual Labs 6 12 Insta
76. he inlet of the Atrium Chamber marked GREEN DD Ei a K 9 7 8 D D v i al Connections with no Heat Exchanger 3 If no heat exchanger is being used connect the silicone tube from the RED outlet of the Aortic Chamber to the RED inlet of the controller If using a heat exchanger proceed to Section 6 16 Connections with a Heat Exchanger Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 38 of 118 tro Pulse Duplicator System User Manual 6 16 Heat Exchanger System Installation Optional Components e Heat Exchanger with Mounting Flange e Heat Bath 1 Mount the Heat Exchanger to the side of the Accessories Table where screw holes are located 2 Connect the silicone tube from the Test Fluid Outlet top of the Heat Exchanger to the Peripheral Resistance Controller 3 Connect the silicone tube from the outlet of the Aortic Chamber marked RED to the Test Fluid Inlet on the Heat Exchanger under side S L is 4 Connect the silicone tube from the right inlet on the Heat Exchanger to the outlet on the Heat Bath 5 Connect the silicone tube from the left outlet on the Heat Exchanger to the inlet on the Heat Bath 6 Fillthe Heat Bath with fluid NOTE It is advised to add an algaecide to prevent algae growth 7 Turn the Heat Bath on and set to desired temperature i e 37 0 C 6 17 Silicon Hose Installation Confirm that the four colour coded silicone rubber ho
77. hen use the tape to hold the two parts together 6 Use a syringe filled with silicone sealant with attached dispensing tip e g EFD Inc 5118PPS B to fill the gap between the glass and aorta exit tube taking care not to entrap air bubbles which could cause leaks Any excess sealant should be wiped before curing occurs Let sealant cure 24 hours Remove adhesive tape from inside surfaces of assembly Re insert assembly into housing reversing the 4 bulleted steps shown above in step 1 eS 12 5 Ventricle Member Replacement The model ventricle and bonded drain tube are made of silicone rubber and should have a long flex life If damaged they may be repairable using RTV Silicone rubber Otherwise replace as follows 1 Remove 8 X head bolts and valve block retaining tabs then remove block 2 Remove polycarbonate base filler ring 3 Move ventricle base aside to gain access to the bonded silicone tube and pull off from polycarbonate tube Reverse above sequence to install new ventricle Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 87 of 118 Vi Vit O Pulse Duplicator System User Manual ADS Inc 12 6 Piston Seal Replacement 1 Remove the three 46 32 x screws located on the front of the piston and remove the SuperPump Piston Cap 09533 6 32 x SHCS 2 Remove the four 20 x 4 5 screws on the front of the pump head Ya 20 x 4 5 3 Remove the Short Extrusion 08981 and end cap from the pum
78. i Follow instructions listed in User Manual Disassemble all parts of the Pulse Duplicator soak in 0 1 bleach solution rinse re assemble rinse and drain system with distilled water 3 times prior to use Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 114 of 118 V V Pulse Duplicator System User Manual 21 Appendix I End User License Agreement The terms and conditions that follow set forth a legal agreement between you either an individual or an entity and ViVitro Labs herein referred to as ViVitro Labs with its principal place of business at 455 Boleskine Road Victoria BC Canada V8Z 1E7 relating to the computer software known as ViViTest and certain other related software modules if applicable herein referred to as Software The term Software includes and these terms and conditions also apply to any updates or upgrades to the software that you may receive from time to time under a subscription service or other support arrangement You may not load or use the Software in any computer or copy it without a license from ViVitro Labs ViVitro Labs hereby offers you a non exclusive license on the terms set out in this Agreement You should carefully read these terms and conditions BEFORE opening the case that contains the Software or installing and using the Software Opening the case containing the Software or installing and using the Software will signify your agreement to be bound by these terms and conditions If you do
79. icense fee you paid for the Software or any fee you paid for the service In no event shall ViVitro Labs or its licensors be liable for special indirect incidental punitive or consequential damages including without limitation damages resulting from loss of use loss of data loss of profits loss of goodwill or loss of business arising out of or in connection with the use of or inability to use the Software or Documentation furnished hereunder and any service supplied from time to time even if ViVitro Labs or its licensors have been advised of the Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 116 of 118 V V Pulse Duplicator System User Manual possibility of such damages Notwithstanding the foregoing in no event shall ViVitro Labs liability be limited in the case of death or personal injury arising as a result of the negligence or willful misconduct of ViVitro Labs 21 7 European Software Directive If the provisions of the Council of European Communities Directive of May 14 1991 on the Legal Protection of Computer Programs as implemented in applicable national legislation the Software Directive apply to your use of the Software and you wish to obtain the information necessary to achieve interoperability of an independently created computer program with the Software as permitted under the Software Directive Interoperability Information you must notify ViVitro Labs in writing specifying the nature of the Interoperability I
80. ing a inch I D hose e g P 79301 20 Evacuate to about 24 inches of mercury vacuum The mixture will expand towards the top edge of the cup and then begin to collapse as the entrapped bubbles burst in the low pressure The mixture should eventually collapse back to its original volume The bursting of the bubbles can take several minutes however this time can be reduced by providing multiple evacuation release cycles during the de aeration process During this cycling process the 24 inches of mercury vacuum condition should be maintained for about 2 minutes Using this method the total de aeration time should be about 10 minutes Release vacuum and remove the cup from the chamber Pour and spatula the mixture into a 30 ml barrel e g 5112CP B and insert piston Expel barrel air as much as possible Attach tapered tip e g 5116TT B to loaded barrel Attach the barrel adapter assembly to an air pressure source e g 800V and set pressure to 40 psig Slowly inject the mixed silicone rubber into the cavity being careful to avoid the formation of air bubbles or entrapment of air Allow the rubber to flow around the cavity The time to fill the cavity with rubber should be about 10 minutes Allow the rubber to cure vulcanize for 16 to 18 hours at 25 C Lower temperatures and or low humidity will cause the cure time to lengthen conversely higher temperatures and or high humidity will cause the cure time to shorten Document No 17473
81. is is complete the data can now be recorded proceed to Section 20 13 Mitral Valve Testing ANALYZE 9 Clicking on the tab in ViViTest will take you to the screen to analyze collected data The software will automatically open the most recently collected data file to open a different file use the navigator on the right side of the screen 10 Note When analyzing data in ViViTest channels can be turned on off by clicking on the desired channel in the legend below the pressure flow curve display This can make it easier to locate crossovers for maker setting 11 Set AO Positive Pressure by setting at ve1 to point where TRANSMITRAL signal first rises above zero and at ve2 to where it crosses back over zero see Figure 6 In other words move at ve1 to the first point at which the mitral pressure is above the ventricular pressure Set at ve2 to the last point at which the mitral pressure is above the ventricle pressure Figure 6 Example of MI Positive Pressure 12 Set V1 Mitral forward volume by moving f3 to the point at which Flowmeter signal begins to rise above the zero line and f4 to the point at which the Flowmeter signal crosses the zero line again See Figure 7 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 112 of 118 Vi Vi Cro Pulse Duplicator System User Manual Labs Figure 7 Example of flow marker setting 13 The closing volume of a valve will usually be a
82. itive Pressure Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 110 of 118 Vi Vit roO Pulse Duplicator System User Manual 5 Set V1 aortic forward volume by moving marker f1 to the point at which Flowmeter signal begins to rise above the zero line and marker f2 to the point at which the Flowmeter signal crosses the zero line again See Figure 4 Figure 4 Example of flow marker setting 6 The closing volume of a valve will usually be a sharp spike of flow in the negative direction Create an imaginary line that runs tangent to the Flowmeter signal along the Straight portion as it begins to rise back towards the zero line Set f3 to where this imaginary line would intersect zero if it were to be extended See Figure 4 and Figure 5 for more detail Markers F2 to F3 will create V3 or the closing volume Y 1 2 0 GZ ieee ve SH X d Y Tangent Key X time Y flowrate 1 closing volume 2 leakage volume Figure 5 Example of closing volume from ISO 5840 7 Set f4 to the point at which the flow begins to rise above zero at the end of the cycle As this is the end of the cycle it should be similar to where f1 was set but at the beginning of the next cycle on the display Markers f3 to f4 will create the leakage volume V4 as shown in Figure 4 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 111 of 118 Vi Vit roO Pulse Duplicator System User Manual Labs 8 Once th
83. itral valves e Measurement units can be toggled by using the mmHg KPa button Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 82 of 118 11 6 Process Display Displays the activity of information gathered In most cases the following will be displayed e a multi axis graph typically showing both pressure and flow data over a 1 35 pump cycle e most recent pressure sensor values for most recent ADC analysis multiple valve cycles Analysis for Trial Check Data 1003 Date 6 29 2007 4 23 26 PM Focus Waveform 10 AO Positive Pressure LEGEND AORTIC VENTRICULAR TRANSAORTIC TRANSMITRAL DERIVED FLOW e A legend bar indicating the meaning of the various coloured graph traces These can be turned on off to highlight specific data to be viewed O O O OO OF ET OO RED line Aortic Pressure YELLOW line Ventricular Pressure BLUE line Atrial Pressure PINK line Transaortic Pressure ORANGE line Transmitral Pressure WHITE line Derived Flow GREEN line Pump dL dt DARK BLUE line Flow meter GREY line Pump Volume The graph can be manipulated by Refresh this allows the data to be refreshed reloaded to display the latest data Restore enables the changes done to the graph view to revert to 1 1 Increase Decrease zoom manipulates the interval frequency of the measured pressure to bring the graph closer or further away Up Down enables the user to position the adapted g
84. lating flow The previously calibrated pump volume dL dt signal is matched to the flow probe signal To proceed with aortic flow probe calibration 1 Insert probe in aortic site as described previously 2 Remove window assemblage on top of aortic chamber loosen bolts holding three retaining tabs rotate tabs to window release position and pull up on window Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 52 of 118 V V Pulse Duplicator System User Manual 3 4 5 6 7 NOTE 10 11 12 Occlude RED and BLUE ports on aorta housing block with rubber stoppers or clamp the tubes securely and clamp drain hose Place silicon rubber annular seal in aortic site and secure the aortic chamber with thumbscrews Occlude the mitral site with solid silicon rubber seal Place atrium assembly over solid seal and secure by tightening the four thumbscrews Add fluid must contain 0 9 NaCl to load reservoir until level just reaches mitral site Continue to fill the system through the open top on aortic chamber reservoir until the test fluid level reaches the level indicated in the diagram on above Remove all entrapped air through ports occluded by stopper 1 amp 2 may be necessary to tilt model It is important to remove all air from the aortic root assembly This can be done via the BLUE port It may be necessary to tilt the model so that all air can exit through this port Switch on the drive to SuperPump and record
85. le under the Edit Waveform Tools Note The Beat Rate has a max value of 400 Do not use a beat rate higher than 220 when running the SuperPump Use the Save icon to save the modified waveform to a file Use the Refresh icon E to view your changes Note Remember to save your waveform before using the Refresh icon when making changes under Edit Waveform Tools Use the Send icon LN send the waveform to the amplifier Note Do not attempt to Refresh or Upload a waveform when the SuperPump is running 9 4 Status Request Use the Refresh icon E beside the SuperPump Status label to update the screen view with the current status of the pump Note the amplitude number represents a percentage value not a stroke volume Waveform index gives the index number of the waveform currently being used by the amplifier Sync pulse delay is given in milliseconds and can be adjusted using the amplifier controls Observe the error code box under the SuperPump Status Any communications failures or other problems will be signalled here Note that an attempt to communicate with the amplifier will be repeated until successful or the software is terminated Note If the USB is disconnected and then reconnected the Refresh Status will not update The SuperPump must be reconnected using drop down menu in upper left corner Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 5
86. lling the Mitral Flow Probe The mitral probe is located between the ventricle chamber and the atrium chamber Remove the left atrium assembly loosen the four thumbscrews and lift Loosen the four bolts securing the mitral flow channel to the atrium chamber Remove white Delrin spacer Insert electromagnetic flow probe Carefully align probe to minimize turbulence Tighten evenly the four bolts Do not use excessive torque aS NS 6 13 Aortic Compliance Chamber Installation 1 Mount the Aortic Compliance Chamber on to the Accessories Table using two red 48 32 x thumb screws provided 2 Connect the silicone tube from the top of the compliance chamber to the Aortic Chamber at the marked YELLOW outlets inlets 6 14 Aortic Room Compliance Chamber 1 Mount the Aortic Root Compliance Chamber on to the Accessories Table using two 8 32 x red thumb screws provided HE Tee d f M MEN v ES Le hh qo A 2 Connect the silicone tube from the top of the compliance chamber to the Aortic Chamber at the marked BLUE outlets inlets ly Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 37 of 118 Vi Vit O Pulse Duplicator System User Manual ADS Inc 6 15 Peripheral Resistance Controller 1 Mount the Peripheral Resistance Controller on the Accessories Table using the two 10 32 x 1 screws provided 2 Connect the silicone tube from the outlet marked GREEN of the controller to t
87. may now be performed using the ViViTest software 8 6 System Check The ground jack on the front panel of the Flow Meter should be connected to the test fluid ground point corresponding to the flow probe site see cabling schematic If the fluid ground point is changed the Flow Meter should be re adjusted per steps starting at the NULL step When the Flow Meter is supplied by ViVitro Labs Inc calibration of the unit using the ViViTest software is carried out prior to shipment The calibration applies ONLY when the front panel control settings are those on the calibration sheet The calibration sheet gives the calibration factor in units of mV ml s This may be used for manual input to the ViVilest software however it is recommended that the flow meter be calibrated daily The calibration sheet compares the volumetric flow rate generated by a piston pump and the resulting flow meter signal During calibration of the flow transducer no air must be in the VIA The ViVilest software will equalize the flow meter output to the instantaneous net ventricle volumetric flow rate generated by SuperPump using a sinusoidal waveform at 70 or 100bpm This volumetric flow rate is obtained by using the piston displacement signal differentiated with respect to time This signal is Output from the SuperPump controller back panel through the output labeled dL dt The dynamic flow transducer calibration is performed with no valves in the Model Heart To take the place
88. moment in time during a valve s trial Results displayed on the report enable the user to identify the trial valve and selected value used for the trial A screenshot of the Process Display area is provided for visualization of the waveforms Poa Using the Print icon MM a report is created within an HTML document These files are automatically saved to your Files folder within the software directory NOTE The report will open immediately to screen A copy will have automatically been saved to the Files folder To Open and Print To keep a physical copy of the report users can 1 Access the file via Explorer under C Program_Files ViVitro_Labs ViViTest Files NOTE The file will be identified with html format The file name will be the identifier information entered for the valve and the date and time Open the desired report Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 74 of 118 V V Pulse Duplicator System User Manual NOTE This will open in a Browser or the computers preferred html file viewing program Select to print from the menu 10 23 Taking a Snapshot Snapshots enable the user to display represented graphs of the trials valve cycle activity waveforms at any moment j Click the Snapshot icon to produce a JPG file of the Process Display area Extra data is included in the file in the top right corner of the graph to identify trial valve and other related data Customizing
89. mparisons To Save Open and Print 1 Using the Save button ke save the current data to an ANA file A save window will display to enable the user to customize the file name alternately the user can opt to use the automatically assigned file name created from valve identifier information data and time To retrieve the ANA file select the desired analysis files on the bottom right side of the software under the directory C Program_Files ViVitro_Labs ViViTest Files NOTE This action will enable the operator to carry out print snapshot and excel export activities pertaining to the data saved 10 26 Log File As an ongoing background feature of ViViTest log files are created each time a user instructs the software to do an activity These files can be accessed via the C Program_Files ViVitro_Labs ViViTest Logs directory as a LOG file To Open and Print 1 Access the file via Explorer under C Program_Files ViVitro_Labs ViViTest Logs NOTE The file will be identified with a LOG format The file name will be the identifier information entered for the valve and the date and time 2 Open the desired LOG NOTE This will open within the computers preferred LOG file viewing program 3 Select print from the menu 10 27 Waveform Design Users can change waveform designs by clicking on Bi sil and selecting Edit Pump Waveforms Designing Custom Waveforms Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 76 of 118
90. n is conducted with the same principals as those previously described for aortic flow calibration Similarly set up the model with no air in the pump head and VIA The instantaneous net ventricle volumetric flow rate should equal the flow rate generated by SuperPump This flow rate is obtained by using the piston displacement signal differentiated with respect to time This is output from the SuperPump power amplifier back panel through the output labeled dL dt The dynamic flow probe calibration is performed with no valves in the system To take the place disc valves mounting rings from the accessories kit contains a silicon rubber flow straightener sealing ring and also a solid seal for the aortic valve non test site To proceed with mitral flow probe calibration preparation 1 Insert flow probe in mitral site as described in the installation section 2 Place silicon rubber annular seal in mitral site 3 Place atrium assembly over seal and secure by tightening the four thumbscrews Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 54 of 118 V V Pulse Duplicator System User Manual 4 Use black rubber stopper to occlude the green hose port or clamp securely and clamp drain hose 5 Add fluid must be 0 9 NaCl to the atrium reservoir until fluid reaches aortic valve site 6 Occlude aortic site with solid silicon rubber seal without trapping air beneath seal 7 Place load assembly over solid silicon rubber seal and secure by tighteni
91. nal waveform Controller Stroke mL s ViViTest Stroke mL s ViViTest value Controller Value 200 EJ 10 s KE Average 2 If different from the internal value Average these 2 values together Select the Pump calibration tab and enter the new value Repeat entering the Acquire Tab of ViVil est process to save it 3 Run both internal and external 550 70 waveforms at various amplitudes and ensure the stroke volume displayed by the controller matches the ViViTest value within 0 1 or 0 2 mL s Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 99 of 118 V V Pulse Duplicator System User Manual 19 Appendix G Calculations Crossover points are defined as follows P1 Pressure Drop Beginning of Systole Positive F1 Flowrate Beginning of systole Forward Flow Pressure Drop F2 Flowrate End of systole forward flow P2 Pressure Drop End of Systole Positive Pressure Drop F3 Flowrate Outflow Valve Closing leakage P3 Pressure Drop Beginning of Diastole Positive begins Pressure Drop F4 Flowrate End of Leakage Cycle P4 Pressure Drop End of Diastole Positive Pressure Drop P Calculated between Positive pressure markers F Calculated between Flow markers H Calculated between first Pressure and second Flow marker General parameters Cardiac Output Liters per Minute Mean Flowrate F1 to F4 Heart Rate beats per min 60 sec min Total Period sec Total Period total point
92. nformation you need and the purpose for which it will be used If ViVitro Labs reasonably determines that you are entitled to such Interoperability Information under the software Directive ViVitro Labs Inc shall at its option either i provide such Interoperability Information to you or ii allow you to reverse engineer the Software within the limits and for the purposes prescribed by the Software Directive solely to the extent indispensable to obtain such Interoperability Information If ViVitro Labs Inc elects clause i you will provide any information and assistance reasonably requested by ViVitro Labs Inc to enable ViVitro Labs Inc to perform clause i and ViVitro Labs Inc may charge you a reasonable fee for making available the requested Interoperability Information unless such a fee is prohibited under the Software Directive 21 8 General Provisions You acknowledge that the Software and the Documentation may be subject to the export control laws of the United States or the United Kingdom and agree not to export or re export the Software or the Documentation i e move the Software from the country in which you first licensed it without the appropriate United States or foreign government licenses and the written approval of ViVitro Labs Inc and its licensors The United Nations Convention on Contracts for the International Sale of Goods 1980 is here by excluded in its entirety from application to this License Agreement The English lang
93. ng thumbscrews 8 Complete filling of chamber until the test fluid level reaches the level indicated in the diagram above 9 Switch on the drive to SuperPump and record the piston displacement piston displacement differentiated with respect to time dL dt and flow probe signals Using the ViViTest FLOW Calibration steps the calibration of these signals can be conveniently determined The phasing between these signals can also be determined If the electronic filters on the instruments are matched typically either 30 Hz or 100 Hz low pass filters then any measurable phase difference for these signals is likely due to the characteristics of the transmission path between the flow generator piston and the flow probe 10 Turn the pump controller amplitude to the desired pump stroke volume typically 70ml NOTE Always verify the flow zero reset electronically by following the software prompts for re Zero 11 Verify the proper flow meter PROBE FACTOR value obtained from the manufacturer calibration label is set 12 The system is now ready for flow calibration in ViViTest A CAUTION about FLOW Measurement Electromagnetic flow probes e m probes are best suited to measurement of uniform streamline flow non turbulent Flow in Model Heart channels may deviate considerably from ideal for e m probes particularly during the leakage flow phase when regurgitant jets from valves produce unfavorable flows in the probe lumen This can be most
94. nt for the target valve is direct or derived Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 49 of 118 Pulse Duplicator System User Manual 8 4 Flow Meter Operational Check NOTE Warning Incorrect mains voltage setting may cause damage to the flow meter Installation Instructions e Refer to the Flow Meter Manual before changing the power plug style j e Check that the voltage switch on the EA NN esr back panel of the unit is set for your Ek mains supply 115 or 230 VAC e With POWER OFF down and PROBE switch OFF plug the power cord into the mains supply NOTE The Flow Meter must be properly grounded e Connect PULS output on the back panel to the flow monitoring device A PHONO to BNC cable for connection to the I O Module is supplied e Connect the 8 pin probe plug to the Flow Meter jack with the correct registration as indicated by the missing pin The flow probe requires a conductive fluid such as saline to properly function It will not function in air or pure water e Connect the ground jack on the front panel of the Flow Meter to the test fluid ground point corresponding to the flow probe site 2 T 6 Aula SS wt e 28 iy Jo AA ture 30 By e Set the MEAN switch to HI e Set the outer dial on the RANGE switch to give a PFX probe factor multiplier of 1 e The frequency response recommendation is 30Hz e The PROBE FACTOR should be set to the manufacturer s Carolina Medical
95. nts to test stentless aortic valves and simulate left ventricular outflow tracts LVOT Although compliant aortic roots with sinuses are not currently provided by ViVitro Labs Inc this instruction describes a method whereby optional ViVitro Labs Inc flanges may assist in mounting the researcher s own structures into the ViVitro Labs Inc Pulse Duplicator System NOTE NOTE NOTE NOTE NOTE The diameter of a compliant aorta will change under dynamic flow and pressure conditions The minimum diameter of the aorta during pulsatile flow testing should be approximately that of the relaxed or molded diameter of the aorta This can be achieved by adjusting the mean pressure on the outside of the aorta using a syringe to inject or withdraw air from the aortic root compliance chamber z it FIGURE LEGEND A8 Catheter clamp with V 006 O ring amp 2 56 x 3 8 inch s s bolts 2 ea A10 High pressure catheter tube A35 Aorta clamp washers amp 6 32 x 3 8 inch s s bolts 2 ea A62 Silicone O ring shown bonded to compliant aorta exit A63 Clamping bolt for part 8 6 32x3 inch 1 each A64 Compliant silicone aorta RVOT no sinuses 13 28 mm ID A64 1 Stentless Aortic valve mounted to aorta user supplied A65 Silicone rubber inlet ring bonded to silicone aorta RVOT A66 Outlet tube male for
96. o meet ISO 5840 to FDA requirements through the use of ViViTest software e Optional components enable o Testing of various cardiac valve types and cardiac structures o Viscoelastic simulated behavior to produce realistic ventricle pressure waveforms o Operate test fluid at 37 C to simulate physiological conditions Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 11 of 118 V V Pulse Duplicator System User Manual 2 3 ViViTest Software This document describes the ViViTest software program designed to acquire data from the ViVitro Labs Pulse Duplicator System in characterizing heart valves This document along with hardware operations manuals for the various elements of the Pulse Duplicator System should be considered as the primary reference document for operations of the ViVilTest software package ViViTest is designed for monitoring acquisition and analysis of data generated by laboratory systems for assessment of heart valves This software is primarily developed for the Pulse Duplicator System from ViVitro Labs For use with other systems please contact ViVitro Labs for technical assistance 2 4 Software Features The software consists of four primary processes Waveform Acquisition Waveform Analysis Waveform Comparison Waveform Review and one secondary utility e Sensor Calibration The ViViTest software is shipped pre installed on a PC Components e Laptop or Desktop PC with monitor keyboard and mouse e UO Mod
97. of Valves NOTE A silicon rubber ring around the valve ring or sewing ring should be used for mounting valves in the Pulse Duplicator System This ring also provides the seal between the atrium chamber and the mitral valve on the ventricle chamber mounting block and between the aortic valve mounting flange and the aortic standoff The soft rubber also helps simulate compliant tissue The valves in their rubber rings can be inserted into the valve mounting flanges The mitral valve corresponds to the site with the longer tapered studs in the valve mounting block The aortic valve mounts in the aortic outflow tract downstream of the aortic flow transducer or substitute Delrin ring Note that the valves in their rings can be rotated around their stream wise axis and mounted in different orientations The mitral and aortic valves are retained by the atrium and aortic standoff respectively 7 3 Priming Preparing the Chambers 1 Add the test fluid through the atrium chamber located above the mitral valve 2 The Aortic Ventricle and Atrium Chambers will fill with fluid Continue until fluid is near the top of the aortic outflow in the Aortic Chamber 7 4 Air Bubble Removal To ensure the data you acquire is accurate it is important to debubble the chambers prior to running your tests Instructions 1 Install a catheter line to the stopcock at the top of the aortic chamber and place the end of the catheter in the atrium chamber to collect ove
98. of disc valves the accessories kit contains a silicon rubber flow straightener sealing ring and also a solid seal The solid seal assures zero flow in the occluded site NOTE After filling refilling with test fluid the meter should be re adjusted as outlined in steps starting from NULL 4 3 2 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 51 of 118 MiVitr Pulse Duplicator System User Manual 8 7 Calibration Procedure for Aortic Flow Probe The diagram below illustrates the proper set up for Aortic Flow calibration Stoppers may be used as shown in the diagram or the tubing can be clamped If the stoppers are used care should be taken to remove the tubing without damaging or breaking the acrylic hose barbs Preparation of SD 2001 1 for Aortic Flow Calibration Temporarily remove aortic view tube assembly Potential sites for entrapped air must be removed Test Fluid Level Annular Rubber Seal Aortic Site Solid Rubber Seal Mitral Site It is recommended that the flow probe be calibrated using pulsatile flow generated in the model This can readily be done using the SuperPump with no air in the hydraulic chamber and VIA The instantaneous net ventricle volumetric flow rate should equal the flow rate generated by the SuperPump The ViVilest software will facilitate the sequence of steps to determine these measurements and determine the calibration factor A sine wave from 70 100bpm is required to create a stable oscil
99. of the Pulse Duplicator and a companion valve is mounted in the opposite test position The test loop is filled with a blood analog solution The valves are then subjected to pulsatile flow operation that is intended to simulate physiologic conditions Measurements of the various chamber pressures and the flow through the test position are obtained The results are used to determine the pressure drops through the valve during the forward flow phase of the cycle and the reflux volumes of fluid during the closing and leakage phases of the cycle 20 3 Cautions e Do not turn flow meter on while system is drained Ensure flow meter is always turned off before draining the system e When flushing pressure ports ensure this is done gradually to ensure pressure limits are not exceeded Watch ViViTest to get a sense of pressures obtained while flushing e Never operate the Pulse Duplicator without ViViTest in live mode with pressure sensors connected and operating properly e When testing valves always make changes to the system gradually if anything seems abnormal stop the system and re evaluate Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 104 of 118 Vi Vit A O Pulse Duplicator System User Manual ADS nc 20 4 Pulsatile Flow Testing 20 5 System Setup 1 Set up Pulse Duplicator per User Manual 2 Mount flow probe in location desired for test either aortic or mitral Duplicator User Manual for instructions Note Ensure
100. of waveforms up to 10 in sequence i e location 1 530 WVF location 2 535 WVF location 3 S40 WVF DESIGNING NEW PUMP CONTROL WAVEFORM USING 2 SINE FUNCTIONS 1 Cycle 1024 points Wavetrain Design ViViTest WaveTrain Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 78 of 118 1 VitrOo Pulse Duplicator System User Manual 11 Software Interface Orientation ca TOP LEVEL TOOLBAR REVIEWING 06184 1049 Trial CALIBRATE ACQUIRE PROGEESS SELEGTION AND SECONDARY BUTTONS we SEE LELE 03 18 20101552 Mite 1048 Aortic Valve vilDise beggen _ Waveform RENEE mechanical 5184 CCnn ERA 15000 il Kate EE Hi Fluid Density oon cm r dE Fluid Temp 3710 C Waveform 03 Target Te Flow Probe Ste TE Target Valve KINE sensor coitroin SUPPORT r or INFORMATION Verde 6 040v 0 307 0 000 Atria 6 075v 0 101 dL dt 0 185v 0 184 Flow 0171y 0 186 Pump 0 113v 0 030 o DO Static Head compensation PA Acquisition Files Trial 1049 03 19 2010 15 09 29 Runbad acq Trial 1049 03 19 2010 15 11 35 Run05 acq Trial 1111 04 30 2010 09 04 58 RunO1 acq Trial 12017 02 18 2010 11 06 32 RunO1 acq Trial 1216 02 26 2010 15 31 42 RunO1 acq Avg Waveform j Trial 1216 02 26 2010 15 41 12 Run02 acq Trial 1234555 04 08 2010 08 40 20 Run01 aca Trial Comparison test 05 04 2010 14 58 02 RunO1 ac f i ee F Trial Comparison test 05 05 2010 08 45 18 Run02 ac ii al FFF ge
101. ogrammed cardiac waveforms created by user Range of capable rates are 4 to 200 beats per minute Range of stroke volume 0 to 150 ml Digital controlled and created waveforms by ViViGen or ViViTest software Control create input or store cardiac waveforms at various physiological states and frequencies through ViVitro software or other std waveform generating equipment e Manufactured by an ISO 13485 accredited facility designed to meet regulatory requirements ISO 5840 and FDA or research needs NOTE The user may opt to manipulate the system to achieve _ alternate states results configurations Should the user carry this out it should be noted that the pressures and flows are kept within the limitations of the system to ensure the system is not overloaded 3 3 SuperPump Initial Set up Procedures The SuperPump System has several steps to the main mechanical sub assemblies and a few steps for the electrical components installation configuration NOTE It is critical for the assembly steps to be followed in order to assure successful operation Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 14 of 118 Vi Vit O Pulse Duplicator System User Manual ADS nc 3 4 Unpacking List of Components The SuperPump AR arrives in 2 containers a wooden shipping crate for the pump and a cardboard container for the controller Inspect the shipping containers for external damage Retain the shipping carton and packing materials for possible re
102. oints Points 9 1 Installation Install the ViVigen Installer exe on the computer This executable program can be found on the supplied flash drive During installation setup check the box Create a desktop icon 9 2 Method Connect the SuperPump Amplifier to the computer using the USB cable Turn on the amplifier Open the ViViGen shortcut icon on the desktop Click the adil abe on the upper left corner to access the drop down menu Select Connect and select a COMX value If the connection is successful the red dot will turn green Click the SES label on the upper left corner to access the drop down menu Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 57 of 118 MiVit Pulse Duplicator System User Manual Select Refresh Waveforms to upload current waveforms from the amplifier to the Waveform Generator console The amplifier and the console are able to access five waveforms 9 3 Icons The left side of the console panel shows five index positions These correspond to the five waveforms stored in the amplifier It is possible to modify these waveforms using the four icons and the drop down boxes for each position Use the Open File icon I to search for a stored waveform in the software package Open the file and view the waveform on the graph Use the Tools icon Si to modify or edit the waveform its label or its Beat Rate Be sure to define the Type and Duty Cyc
103. ole diastole ratio corresponding to a systolic duration percentage characteristic waveform and beat rate in beats per minute Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 48 of 118 V V Pulse Duplicator System User Manual 8 3 Calibration of Flow Probe Methods There are two distinctive methods to collecting flow measurements Each should be considered prior to starting so that the proper set up and recognition by the ViViTest software is performed NOTE Direct Flow This is the most common type of measurement The flow probe should be mounted in the position of interest i e aortic valve flow measurement requires the flow probe to be mounted on the Aortic Chamber side of the Heart Model The ViViTest software will automatically determine flow for the probe site based on the target probe site and target valve If these entries are the same the software will recognize the system as configured for direct flow measurements Derived Flow This type of measurement is used when the experimentalist notes a problem that is noticeable as leakage flow computing to a positive value This can result when using the electromagnetic flow measuring system and a disturbance of the flow field around the flow probe occurs The problem can be particularly noticeable when using mechanical valves where small leakage paths can give rise to relatively high velocity regurgitant fluid jets and consequent highly disturbed flow in the model flow
104. on Factor is entered The Piston Area should match the area listed on the decal on the rear of the SuperPump a Pump Calibration 1 o Operators have the option of using the calibration wizard to measure a new 2 point calibration gain or editing the current calibration value manually Current calibration gain from calibration cfile Bie mle ici ame 200 000 mV ren e om Click ACCEPT when done Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 62 of 118 V V Pulse Duplicator System User Manual 10 4 Flow Meter Calibrating the Flow Meter E With this calibration the flow rate through the transducer will be made directly proportional to the piston displacement signal differentiated with respect to time dL dt The latter signal is an output from the pump amplifier The PROBE FACTOR should be set to the manufacturer s recommendation See Carolina Medical label The probe factor shown in the red circle translates to a setting of 4 38 on the flow meter potentiometer Reference the probe factor calibration label provided with the flow probe for proper set up Carolina Medical Electronics Inc 4125 Old Mill Rd East Bend NC 336 983 5132 BLOOD FLOW PROBE MODEL no EP688 connector __PV 8 LUMEN size B mm SERIAL NO AO _ DO NOT DISCARD THIS LABEL Following the calibration wizard instructions the software will automatically adjust to create a calibration factor for the flo
105. ontrol access to the Software You may not take any steps to avoid or defeat the purpose of any such measures Use of any Software without any required lock device or authorization key is prohibited 21 2 Ownership of the Software Restrictions on Copying ViVitro Labs or its licensors own and will retain all copyright trademark trade secret and other proprietary rights in and to the Software and the Documentation THE SOFTWARE AND THE DOCUMENTATION ARE PROTECTED BY COPYRIGHT LAWS AND OTHER INTELLECTUAL PROPERTY LAWS You obtain only such rights as are specifically provided in this Agreement You may copy the Software into any machine readable form for back up purposes and within the license restrictions You may not remove from the Software or Documentation any copyright or other proprietary rights notice or any disclaimer and you shall reproduce on all copies of the Software made in accordance with this Agreement all such notices and disclaimers 21 3 Other Restrictions on Use This Agreement is your proof of license to exercise the rights granted herein and must be retained by you You may not use any portion of the Software separately from or independently of the Software and other than for your normal business purposes You may not provide access to or use of the Software to any third party consequently you may not sell license sublicense transfer assign lease or rent including via an application service provider ASP or timeshare arrang
106. or Aortic Flow Probe onnnannnnnnannnnnnnnnnnnnnrnnnrnnrnenrrnrrerrnnrrenrnne 52 8 8 Calibration Preparation of Mitral Flow Probe 54 8 9 Calibration of Pressure Measurement System AP9991 Initial Getup 56 9 ViViGen SOTMWANC Larsnes 57 gt Eege 57 lt MENN 57 SEG Oe E 58 SEN 58 9 5 New Waveform Generation 59 10 ViViTest Software Operation cccssccsseseseeseeceeseseeseesenseeeeneeeenseseeneseensesonseseeneesonnenes 60 10 1 Calibration Process Overview rrrrnrrnararranennnrnnanennanernnnnnanernnnenanennanennnnnnanennuennsennanennn 60 10 2 VNR 61 10 3 Pump Keel EEE EEE 62 10 4 Flow Meter Calibrating the Flow Meier 63 10 5 Pressure Calibration Calibrating and Zeroing the Gensors 66 10 6 Zero Calibration Measuring Sensor Zero References rrnrrrrarannnnennnrnnanennnnevanennnnennn 68 10 7 Finishing Calibration Updating the Calibration Ee 68 10 8 Acquisition Process TE 68 VE GE Valve V N aO a E EE E E E E 69 10 10 Rezero E 69 TOALLA IZO POCOS r E E 69 10 12Crossovers and Interval Identification rrrorrrrnrernnrrrnnrrrnnernnrrrnnrrnnnernnrnranennnrennnennnsennn 70 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 5 of 118 V V Pulse Duplicator System User Manual VI FEN 71 10 14Derived Flow Measurements arannnrnnnnrnnnnennnrnnnnennnnennnrnnnnennnnnnnnennnnennsrnnanennnsennsennnsennn 71 EE deeg 71 10 16C0mpare PORS ar 72 10 17Comparing Groups of Tale 73 10 2
107. or Calibrations panel on the right hand side of the screen Each of the calibration processes has a navigation panel where users have the opportunity to proceed to the next step or accept the values as presented Should previous steps need to be revised the user may repeat the process or alternately take a step back to revisit the data entered Close At any time during the calibration process users can abort by selecting the Close button This immediately cancels the calibration sequence without saving any of the newly input values D Collapse The Collapse button enables the user to momentarily stall the calibration process without losing the values entered It causes the Wizard to reduce to a thumbnail in the left hand corner of the screen Wizard Once the Collapse button is selected a thumbnail Thumbnail will appear in the bottom left corner of the screen Selecting this thumbnail returns the Wizard to its full size once again Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 61 of 118 1 VitLrO LabS inc 10 3 Pump Calibration o_o The pump piston linear displacement is measured for each unit The factor in mv mm is provided by ViVitro manufacturing The value as shown below is used by the ViViTest software to calibrate the pump The Linear Transducer Ch 6 value should be pre set from ViVitro between 195 and 199 follow the ViViTest pump calibration procedure in the Appendix to ensure the correct pump calibrati
108. oratory notebook as they are tested Filling Pulse Duplicator Add test fluid through atrial reservoir Begin pumping fluid by turning SuperPump up to a stoke volume of 50ml stroke Turn flow probe on by turning Probe knob on the flow meter to Continue to add test fluid as required It is recommended that the height of the test fluid in the atrium should fluctuate about the same level during testing This can be adjusted by either adding removing air from compliance chambers or adding removing test fluid Use reference level marked on atrium as a reference J 6 Remove any air collected in aortic view port or atrium using overflow tube or atrial pressure port respectively Ensure pressure transducers are free from air bubbles Flush with a syringe or bleed fluid from the system Add air to compliance chambers if necessary as this will affect the fluid level in the system Confirm fluid level is appropriate as above Run system until appropriate temperature is reached measure using calibrated thermometer Zeroing the System This is conducted before each data set is collected to account for any baseline drift on all inputs but most importantly to account for any flow meter drift Ensure system is at the desired testing temperature and has been running for 5 minutes The flow meter should be on the on position Ensure pressure transducers are free from air bubbles Flush with a syringe or bleed fluid from the
109. ortic view port each time the Pulse Duplicator is stopped and will need to be removed every run 6 Use peripheral resistance knob to adjust either Mean Aortic Pressure or back pressure per the test plan 7 Adjust root compliance such that test fluid is not rising up silicone tubing If too much air is added it will by pass the aortic root and will need to be flushed according to step 5 5 8 Adjust aortic compliance such that test fluid is rising and falling around the approximate half way level of the chamber If testing at 100 mmHg the aortic pressure should be varying between 120 10 and 80 10 mmHg 9 Adjust VIA compliance if specified in the test plan Record any changed in lab notebook 10 Stop the pump 11 Re zero system according to Section 20 9 12 Repeat steps 20 10 3 through 20 10 9 to ensure desired conditions are still being met before proceeding with data capture sd nd e Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 108 of 118 V V Pulse Duplicator System User Manual 20 11 Data Capture This section describes the process for testing a single valve This will have to be repeated for each valve in the test plan er NAD TAS Once system has stabilized with desired parameters click Once data is collected save in desired test folder using name VALVE ID RUNXX Install test valve in Pulse Duplicator in position to be tested as per Section 20 7 Fill system as per Section 20 8 allowing system to com
110. ot tool provided in the Accessories Kit to adjust the 15 turn potentiometers for GAIN amp SHIFT The extreme position indicated by a click may be located by rotation of at least 15 turns clockwise or anti clockwise A two point pressure transducer calibration method can be made as follows o Connect amplifiers to pressure transducers and switch amplifier ON o Use a syringe to fill the pressure transducers with distilled water o Adjust the SHIFT control to give 6 0 volts output at 0 mmHg gage pressure atmospheric o Apply a pressure of 200 mmHg to transducers and adjust GAIN for 6 0 volts output o Repeat steps 4 and 5 to achieve the stated outputs o CALIBRATION voltage pressure 12 V 200 mmHg 0 06 V mmHg NOTE The GAIN and SHIFT settings may need to be changed depending on the range of pressure generated in the specific application Different settings may be needed for monitoring the ViVitro Labs Inc Pulse Duplicator System Changing GAIN will also change the output at atmospheric pressure It may be necessary to re adjust SHIFT until the required outputs are obtained at the two calibration pressures i Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 56 of 118 MVitr Pulse Duplicator System User Manual 9 ViViGen Software ViVitro ViviGen Waveform Generator SuperPump Waveforms Index 3 WW i Beat Rate fo Paints f h Beat Rate p ed Mn 10 0 500 600 700 800 900 I Data P
111. ove overflow tube to aortic drain port to speed up draining Ensure valve is removed promptly upon system draining Rinse valve if necessary before placing in container eh Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 113 of 118 V V Pulse Duplicator System User Manual 20 15 Data Quality Assurance This section is meant to identify potential procedural errors Test samples may vary from the expected results below 1 2 Eh S md E Forward flow performance Runs 1 4 Decreasing RF as CO increases similar closing and leakage with increasing forward flow Constant EOA possible deviation at low flow Forward flow pressure drop and Qrms plot should be linear 70 BPM and 5 LPM cases leakage should increase with backpressure and EOA should remain constant Regurgitant Performance Closing volumes should be constant for a given beat rate Closing volume should increase with beat rate EOA should be constant at each beat rate set Leakage volumes should increase with increasing back pressure However bio prosthetic valves may seal better with increasing back pressure potentially reducing leakage 20 16 Reporting Test Results 1 2 3 Create test report Include a snapshot from high speed video of each valve at both full systole and full diastole Include any relevant photos taken during valve inspection 20 17 Maintenance 1 2
112. p Initial Set up Procecdures aursmassindaradnnanidneiaid naiiai 14 3 4 Unpacking List of Components rrrannrnnanrrnannennnnenrnnrrnnnnenranrnrnnnennnnrnnnnnennnsennnnsennnssnnnn 15 35 IMSTAlING ne SUPEPUTP ae Seegen es inationdadechandtiectiseds ieetandtteutinds Seed enges ege 15 O FOTP N e snd succeded a EE E E E acne 15 S 5 Mr UV EE crore cascrcoprerneremne eanannce enema emnanoorer apnea wots 16 3238 EICCIFICA IRCOUNCIICINS ta cumrinh a emminn eats a 16 Be EEE 16 4 Running the SuperPump System annernnnnnnnnnnnnnnnnnnnnennnnnnnnnnennnnennnnnnnnnnennnnnnnnnnennnnennnnnen 17 4T VENNE 17 A EP EE EEE KE 18 4 3 Select Waveform rrrarrrnnnnrnnannvnnnnvrnannnnnnnrnnanrnnnnnrnnanrnnnnnrnnansnnnnnrnnnnsnnnnnnnnnnennnnnnnnnnsennn 19 e RE E E EE 19 4 5 ChangetbeCvceCGoumt 19 AG PUNO G 1 10 ge E E E iE 20 4 7 SuperPump Faults and Alarms x seisescocevc assencesacdenceracesenocmenteserodesnaesencunsneesneeneseeentaeieneeed 20 10 FEN 21 4 9 Pump Mounting Details Feet Bolt Pattern rarrnnnennnennnrnnnennnrnnnrnnnennnrnnnennnennnennnennnnn 22 4 10 Pump Cylinder Mounting Face Bolt Pattern rrnnrnnnnrnnnnnnnnnnnanennnrrvnnrnnnnennnnnnnnrnnnnennnnnn 22 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 3 of 118 V V Pulse Duplicator System User Manual 5 Valve Mounting and Molding Procedure n ranvrnnuvnnuvnnunnnunnnunnnunnnunnnunnnunnnvrnnvnnnvnnnvnnnunnne 23 5 1 Rubber Ring Moulding Considerations
113. p assembly M10 Nut and Lock Washer Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 88 of 118 Vi Vit A O Pulse Duplicator System User Manual ADS Inc 4 Carefully remove the glass cylinder from the piston CAUTION DURING THIS STEP BE CAREFUL WHEN HANDLING THE GLASS CYLINDER AS THE EDGES MAY BE SHARP 5 Remove the M10 nut and lockwasher from the front of the piston 6 Remove the SuperPump Piston 09532 from the rod end Piston Seal 7 Locate the small hole near the outer edge of the piston Holding the piston firmly press off the piston seal with a small hex key Be sure not to scratch or damage the piston sealing surface during this step Push from this face Piston Sealing Surface 8 Check the sealing surface of the piston for scratches that are either visible or can be felt with a fingernail Ensuring the orientation is correct snap the piston seal onto the piston carefully by hand 9 Clean any dust and debris from the glass cylinder Apply two pieces of electrical tape to one edge of the glass cylinder Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 89 of 118 1 VitrOo Pulse Duplicator System User Manual 10 Push the piston into the glass cylinder SPM042 using the tape as a glide point Remove the electrical tape from the Glass Cylinder SPM042 11 Slide rod end into the SuperPump Piston 09532 Fasten in place with a M10 Lock Washer 09538 Loctite and the nut from the rod end
114. p either turn the Amplitude Dial to 0 or press the Amplitude Dial In this case an Emergency Stop alarm will appear To clear this alarm press the Amplitude Dial The pump will automatically perform a Homing Sequence 4 7 SuperPump Faults and Alarms 4 7 1Emergency Stop If case of an Emergency Stop press the Amplitude Dial to clear the alarm and Home the pump 4 7 2Limit Switch The SuperPump actuator contains a factory set limit sensor for the maximum push and pull stroke In case of a Limit reached alarm press the Amplitude Dial to clear the alarm and Home the pump 4 7 3Pump Error If the Controller loses communication with the Pump or if the Pump is unable to move a Pump error message will appear If this occurs 1 turn off the system 2 check that the cables are properly installed 3 ensure that the pump is free of mechanical interference and damage 4 turn the controller on and allow it to initialize normally 5 Ifthe alarm persists contact the manufacturer Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 20 of 118 Vivi 4 8 Specifications Pulse Duplicator System User Manual Pump bore diameter Pump stroke Displacement Rate Nominal 69 85mm 2 750 0 40mm 20mm 0 150mL 4 to 200 beats per minute External Waveform Position DL dt Sync 0 10 Vpp 0 067 Hz to 3 33 Hz 4 to 200 beats per minute 5 to 5 V 200mV mm 5 to 5 V 539 ml s V 5V TTL LE at rising zero c
115. problematic at high cycle rates and flows The flow signal must therefore be interpreted advisedly In particular a positive flow signal seen during the leakage phase for a valve known to seal is indicative of an erroneous flow signal This problem may be reduced by rotating probe or valve about the central flow streamline to minimize direct impingement of jets on the electrodes Additionally a rigid or less compliance mount can reduce the effects of positive leakage Another solution for this flow measurement problem is to use indirect flow measurement For a leaking valve in the aortic test site the alternative method of measuring flow is by placing the flow probe in the mitral site and eliminating any compliance between pump and ventricle In this way the pump displacement differentiated with respect to time dL dt becomes the ventricle net volumetric flow rate In this case with the e m probe in the mitral site impingement of jets on electrodes should be less problematic because of the mitral flow channel configuration The ViViTest software handles synthesis of the derived aortic flow signal from the e m probe mitral site flow signal and the pump dL dt Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 55 of 118 V V Pulse Duplicator System User Manual 8 9 Calibration of Pressure Measurement System AP9991 Initial Setup 1 Switch the unit ON rear panel Allow the amplifiers to warm up for 30 minutes to achieve minimum drif
116. r of the world s first Pulse Duplicator the ViVitro name has been synonymous with cardiovascular device testing equipment ViVitro hardware and software products have been used by leading R amp D facilities and academic labs worldwide and its equipment and testing methods being cited in hundreds of peer reviewed publications http ViVitrolabs com company cited publications The ViVitro Labs Pulse Duplicator System in particular the ViVitro Labs SuperPump has become a worldwide standard to simulate physiological heart conditions in academic research applications ViVitro products are manufactured by StarFish Medical in an ISO 13485 2003 certified manufacturing facility ViVitro Labs Inc also holds ISO IEC 17025 accreditation for laboratory testing services endorsed by A2LA and based on ISO 5840 This scope of accreditation includes 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 ViVitro Laboratory Services are engaged worldwide for hydrodynamic durability and flow visualization testing of heart valves and other cardiac devices ViVitro has been the trusted name in regulatory approvals for over 30 years and is renowned for its proven success from product development testing through to full regulatory submission ViVitro Labs is a member of the ISO 5840 standards committee and i
117. ranerrnnnennanenvnnnennnnennansennnnennunennnnnennunennne 38 6 16 Heat Exchanger System Installation COptponal 39 6 17 Silicon Hose INStAN ANON EE 39 ble BA MENE 40 6 19 Electrical Connection Dagram 41 7 Testing Setup Procedur s oviscnsicccccccctccccsevesencenricctdeessnenecestavecastenwansnntesssvessseetesttorwdasvcaes 42 7 1 Initial Assembly Procedure cccceccceccceeeeceeeeseeseeeeseeeeeueeseueeseessuseseeeeseeesseeeseeesaneess 42 TE MAOO EE 43 73 Priming Preparing ht eru 43 7 4 Air Bubble REMOV ssen 43 7 5 Characteristic Compliance and Liquid Level Adiusiment 44 7 6 Peripheral Resistance Adjustment rrranrrnnnrrnnnrnnnnnvnnrnnanennnrnnanennanennnrnnnnennnnnnnnrnnnsennsen 45 Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 4 of 118 V V Pulse Duplicator System User Manual 7 7 Pressure Waveform Adjustment EE 45 7 8 Viscoelastic Imedance Adapter VIA adiustments 46 79 Mean Atrial PressS re deed Seed ee ed Bee BEE aiian kira EE ed geg 46 G Le Transducer SENOS vr 46 8 System Preparation for Calibration rnnnxennnnnrnnnnennnnnnnnnnnnnnnennnnnnnnnnennnnnnnnnnennnnennnnnen 48 8 1 Pump Calibration Operational Check 48 8 2 Drive Waveform Generator Operational Check 48 8 3 Calibration of Flow Probe Methode 0 nnn0nnnannnnnnnnnnnnnnnnnnnnnrnnennnnnrnernnenrnenrnsnersnrrnneene 49 8 4 Flow Meter Operational Check 50 5 NLP NNN 51 KE SIS GCC eege EE EN 51 8 7 Calibration Procedure f
118. raph data more centrally on the screen by adjusting the Y axis Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 83 of 118 V V Pulse Duplicator System User Manual 11 7 Process Output The software uses a number of various calculations to output accurate and relevant information for your review Some of the standard formulas have been listed below for your ease of reference Please reference Appendix E for a more complete list of calculations used For anything further please contact ViVitro Labs directly EOA aes 51 6 Joe 11 8 Help Information pertaining to the screen or the software in general Help is available throughout the use of ViViTest Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 84 of 118 V V Pulse Duplicator System User Manual 12 System Maintenance 12 1 Required Fluid There are 3 zones of your system that will require differing fluid requirements 1 The main operating zone within the Model Left Heart Peripheral Resistance Controller and connecting tubes 2 The pulse duplicating zone within the pump head VIA if installed and Ventricle Chamber 3 The heat exchanging zone within the heat exchanger heat bath heat pump and tubing Zone 1 Depending on your requirements the following fluid information is provided as a guide for use in the system Fluid e Saline or e A blood analogue fluid consisting of 35 glycerin 65 saline by volume This mixture having a density of approximately
119. rflow 2 Ensure the lid is fastened to the top of the aortic chamber 3 Check that the peripheral resistance controller is open at least two full turns 4 Via the Amplifier a Start the SuperPump by slowly turning the Amplitude knob b Adjust the Amplitude setting to a low stroke volume approx 30 mL stroke 5 Open the stopcock to vent air from the inside of the aortic chamber Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 43 of 118 V V Pulse Duplicator System User Manual 6 Add fluid to the atrium as necessary to the system to prevent air bubbles from being circulated 7 Close the stopcock when all air has been displaced by test fluid NOTE It may be necessary to increase the pumping rate stroke volume and reduce the Peripheral Resistance to remove all air bubbles Monitor aortic pressure and avoid excess pressure in the system 7 5 Characteristic Compliance and Liquid Level Adjustment Note The instructions for Aortic Root Compliance Chamber and Aortic Compliance Chamber fluid levels should be conducted simultaneously Aortic Root Compliance 1 With the stroke volume set at a given value e g 70 ml 70 beats minute the pressure of the air above the fluid surrounding the Aortic Root should be adjusted so that the highest level of fluid in the aortic housing almost reaches but does not occlude the tube port making connection to the Aortic Root Compliance Chamber 2 Using a syringe apply or release air as neede
120. ring should remain in situ when making rubber rings intended for use in the mitral site of the ViVitro Labs Model Heart and load systems The Insert E Dark GREY should be removed when making rubber rings for use in the Leakage Tester and the HiCycle test systems This ring may also find use as a filler in the aortic valve mounting site when thin rubber rings intended for use in the mitral position are to be used in the aortic valve mounting site 2 With the middle ring YELLOW over the base PURPLE attach the device or replica light GREY so that it is centered and square to the base rod PURPLE The method of attachment will depend on the device 3 Fill the assembly with silicone rubber Gl 1100 recommended which has been de aerated as described later Prior to complete jig assembly and filling with rubber it is recommended that rubber first be applied to deep undercut regions using the barrel reservoir and tapered tip B This avoids entrapping air in those regions where the flow of the viscous rubber can be problematic 4 Place the upper ring GREEN over the middle ring YELLOW and lock with thumbscrew C Adjust the locked assembly GREEN YELLOW on the base PURPLE so that when rubber fills the cavity the top level of rubber is even with the top edge of the upper ring GREEN and about 2 3 mm of rubber covers the top ridge of the pedestal or device TAN This top covering layer of rubber should be sufficient to secure the test
121. rossing Power Requirements Voltage Power 90 240 VAC 50 60Hz Max 300W Dimensions Controller Pump Document No 17473 V1 3 11 x 48 x 33 cm 15x55x 17 cm O ViVitro Labs Inc 2014 Page 21 of 118 Vi Vit O Pulse Duplicator System User Manual ADS In 4 9 Pump Mounting Details Feet Bolt Pattern 391 5 N lt UuPPER MOUNTING HOLES 4 X 10 32 X 14 mm DEEP FOOT MOUNTING HOLES 4X 5 1mm THRU 4 10 Pump Cylinder Mounting Face Bolt Pattern 6x 24 5 THRU ON 102 26 mm BCD Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 22 of 118 MiVit Pulse Duplicator System User Manual 5 Valve Mounting and Molding Procedure 5 1 Rubber Ring Moulding Considerations Silicone rubber rings are recommended for mounting heart valves or other test specimens The rubber rings provide a fluid seal between the device under test and the test system flanges CUSTOM PEDESTAL BARREL RESERVOIR A AND TAPERED TIP INSERT SDM0405A FA UPPER RING SDM0426A i lt _C MIDDLE RING SDM1416B lD Sl m LS _ NOTCH 2 PLACES la be E E gt gt BASE SDM1416C EE 1cm Since each size and type of test device differs in geometry a unique rubber ring is required in order to match and seal the appropriate boundaries on the device The rubber ring should not interfere with the action of the device being tested The considerations discussed here
122. s e g VSI BC bi leaflet tissue valve can use a plastic rather than a fabric cuff This simplifies the design of the proto type valve and fabrication of both the mounting and rubber rings A molding kit is supplied to assist in making rubber rings The standard kit consists of the following parts 1 each molding jig components 1 8 pounds GI 1100 Silicone rubber Silicones Inc 1 each dispensing syringe enlarged end port 35 ml 0 2 pounds GI 1100 Activator Silicones Inc 1 each dispensing syringe 1 ml 1 each standard dispensing syringe 35 ml 1 each gage tapered tip 45116TT B EFD Inc 100 ml waxed paper mixing cup and wooden spatula 1 ml mold release grease Vaseline in syringe 5 2 GI 1100 Silicone Rubber This rubber is made by Silicones Inc P O Box 363 211 Woodbine Street High Point NC 27260 USA Ph 919 886 5018 Fax 919 886 7122 It has extremely high tear strength and is a highly elastic two component tin catalyzed RTV Room Temperature Vulcanizing silicone rubber Specifications include e Hardness Shore 22 14 Tensile Strength AStm D412 525 125 psi Elongation AStm D412 400 125 Tear Die B AStm D624 140 115 ppi Shrinkage 0 1 Specific Gravity 1 07 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 24 of 118 V V Pulse Duplicator System User Manual 5 3 Ring Moulding Procedure 1 Insert E dark GREY is removable This
123. s Tighten the fasteners evenly and ensure the fasteners are not overtightened Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 28 of 118 tro Pulse Duplicator System User Manual 6 4 Attaching the Ventricle Chamber NOTE The three screws should be tightened evenly and NOT BE OVER TIGHTENED Be careful that the bolt entering the blind tapped hole in the Ventricle Chamber does not bottom out when tightened as this will damage the acrylic material of the chamber Fasten the Ventricle Chamber to the VIA using 3x 48 32 x 1 screws and flat washers Tighten fasteners evenly and be extremely careful not to overtighten an damage the acrylic If no VIA is being used with the system y KAN 6 5 Filling the Ventricle Chamber VIA if installed and Pump Head REQUIREMENTS 0 8 to 1 5 liters of de aerated fluid It is further recommended to use distilled water with biocide to reduce bioburden An appropriate biocide can be determined by a reputable supplier NOTE It is recommended that the ventricle chamber be filled with de aerated fluid to minimize the formation of small air bubbles which may reduce visibility and introduce artifact in echo studies NOTE Ensure the SuperPump is set at the home position in the centre of its range movement before filling therefore creating minimal expansion or collapse of the ventricle membrane during operation 1 Fill the ventricle chamber with fluid 0 8 liters
124. s actively engaged in developing regulatory requirements Leveraging this intimate knowledge of the standard ViVitro Labs ensures that test protocols will meet ever changing regulatory requirements ViVitro s Laboratory Testing Services offers an ISO IEC 17025 certified lab using ViVitro equipment to conduct 3 party independent testing ViVitro s accredited testing lab is governed by a mature Quality Management System QMS certified to meet the ISO 5840 This gives assurance to stakeholders and regulatory bodies that results are obtained by qualified personnel using traceable calibrated equipment and up to date test methods all supervised by a quality assurance department Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 9 of 118 V V Pulse Duplicator System User Manual 1 1 Cautions and Warnings e After you receive your Pulse Duplicator ensure that you let the electrical enclosures sit indoors at room temperature for at least one day before plugging them in e The systems must not be used in environments at higher than 75 humidity e Read all of the instructions before operating the SuperPump e This instrument is intended for research use only and must be operated by trained lab personnel e 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 side of the controller and motor end of the pump Make sure that the f
125. s between F1 to F4 sample Rate samples sec Total Period sec samples between F1 to F4 sample Rate samples sec Flow parameters Pump Stroke Volume ml Maximum Position signal Minimum Position signal Cross sectional Area of piston Calculated Stroke Volume ml Cardiac Output l min 1000 ml l Heart rate beats min Systolic percent of time samples between maximum and minimum position signal points between F1 and F4 Forward flow time samples between f1 to f2 sample Rate samples sec F3 to F4 for Mitral RMS Forward Flow ml sec RMS Flowrate f1 to f2 1000 60 sec min F3 to F4 for Mitral Mean Forward Flow ml sec Mean Flowrate f1 to f2 1000 60 sec min F3 to F4 for Mitral Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 100 of 118 V V Pulse Duplicator System User Manual Forward Flow Volume ml Flowrate Area F1 to F2 1000 ml Liter 60 sec min F3 to F4 for Diastolic FF volume Closing Volume ml flowrate Area F2 to F3 1000 ml Liter 60 sec min F1 to F2 for Mitral Leakage Volume ml flowrate Area F3 to F4 1000 ml Liter 60 sec min F2 to F3 for Mitral Regurgitant Fraction RF closing volume leakage Volume 100 Forward Volume Forward Flow Ratio Forward Flow time 100 Sample rate samples sec Mean Leakage Flowrate ml sec 1 Mean Flowrate F3 to F4 F2 to F3 for Mitral Pressure parameters Mean Pressure Drop P mmHg
126. se Duplicator System User Manual Export CSV To put the same calculated results into an editable file for later off line analysis select the Export CSV icon this creates a comma separated value CSV file ko Printed Report Users can create a report of the Analysis by selecting the Print i icon to write an HTML file to the Files folder Verify the data shown in the on screen report review NOTE Files generated by the software such as CSV files or HTML report files are written to C Program Files ViVitro Labs ViViTest Files unless otherwise directed 10 16 Compare Process COMPARE The Compare Process allows users to compare analysis for a series of valve trials e for one valve e against a similar series of trials for a second third valve Area Energy Pressure Requrge Features of the Compare Process interface e Main Process Control select categories of mean data to be plotted e Various Y axis data types can be selected by selecting the direction buttons flanking the Y axis label e Various X axis flow data types can be selected by selecting the direction buttons flanking the X axis label e The range of the X and Y axes are controlled by the zoom buttons EE at the right or top end of these axes e The Data Dashboard is split between a pair of trials selected from 2 groups The following data types may be shown Area Graph displays curve of selected groups for Area P pressure PF
127. ses are connected correctly between colour coded ports 1 MAEKA from the port on the top of the aortic assembly to the smaller of the two compliance bottles This provides characteristic compliance supplementary to that in the aortic assembly 2 B IS from the port to the air volume surrounding the aortic root to the larger of the two compliance bottles This provides supplementary aortic root compliance 3 HEN from the outlet port in the aortic root enclosure to the inlet of the peripheral resistance or the heat exchanger inflow port 4 GEGEN from the outlet of the peripheral resistance to the inlet of the left atrium assembly Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 39 of 118 V V Pulse Duplicator System User Manual 6 18 Electrical Connections The 6 electrical components used to control and monitor the mechanical components of the Pulse Duplicator System are SuperPump SuperPump Amplifier Flow Meter AmPack Computer I O Module aa ol hen See Page 42 for an annotated image of the components STOP CHECK YOUR COUNTRY S POWER SUPPLY AMPERAGE AND VOLTAGE PRIOR TO CONNECTING INTO A POWER SUPPLY ViVitro Labs Inc will endeavor to have your system s components adapted to meet your country s power supply however as an extra precaution it is advised that all equipment designated to be connected to a power supply be checked prior to use 1 Check that the voltage setting on the back panel of the Flow
128. sharp spike of flow in the negative direction Set f1 to the point at which the Flowmeter signal first crosses the zero line on the left side of the screen Create an imaginary line that follows the tangent of the Flowmeter signal along the straight portion as it begins to rise back towards the zero line Set f2 to where this imaginary line would intersect zero if it were to be extended See Figure 5 and Figure 7 for more detail 14 Once this is complete the data can now be recorded proceed to Section 20 13 20 13 Recoding Data 1 Data should be recorded in the lab notebook in accordance with the lab s procedures 2 Click the button to bring up the analysis table 3 Click the Pe button to save ACQ file Use the same file name as used in step 20 11 22 4 Close analysis table 5 Record the following information in lab notebook for each run of each valve 6 Run Begin at RUNO1 and increment for each test condition 7 lf a run at the same condition has to be repeated keep the same number and affix a letter and increment as necessary example RUNO3B RUNO3C 8 Stoke Volume mL 9 Cardiac Output LPM 10 Mean Aortic Pressure mmHg or Back Pressure mmHg 11 Closing Volume mL 12 Leakage Volume mL 13 Regurgitant Fraction 14 EOA cm 15 Waveform Sine50 Sine30 FDA etc 20 14 Drain Remove Valve Ensure flow meter is turned off before system is drained Open ventricle drain and m
129. ssure ports are open to the test fluid The flow signal should read zero and all the pressure tracings should be at the same level as the ventricular pressure as shown below Figure 1 VENTRICULAR Figure 1 Calibration verification 15 Drain Pulse Duplicator according to Section 20 14 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 106 of 118 V V Pulse Duplicator System User Manual 20 7 Inserting Valves Do not insert bio prosthetic valves without immediately filling system with test fluid Handle valves per manufacturers instructions for use 1 Note Insert the valve and holder assembly into the Pulse Duplicator as instructed in the User Manual Note Holders can be used with and without a step If a holder has a step remove the keeper ring as listed in the Pulse Duplicator User Manual lt is recommended that post one is oriented towards the inside the of the Pulse Duplicator i e If testing an aortic valve ensure that post 1 is oriented towards the mitral chamber this will ensure constant high speed videography If testing a bi leaflet valve ensure axis between the leaflets is oriented towards the mitral chamber so gravity will have the same effect on both leaflets 2 3 4 20 8 1 2 3 4 Note If necessary carefully insert outflow tract of valve into glass aorta Install the companion valve as stated above For each valve record the valve s manufacturer serial number and size in the lab
130. t NOTE Warm up time can be avoided by leaving the unit on continuously This will not damage the system Select the desired filters using the filter switch located on the front panel of each amplifier For pulse duplicator measurements 30 Hz is recommended o INPUT always use the locking screws on the cable connector o GAIN adjustable by 15 turn potentiometer o FILTERS A five position switch selects upper frequency cut off Normally this should be lower than the natural frequency of the transducer o SHIFT 15 turn potentiometer each turn shifts output 2 5 volts between full scale 12 volts For additional specifications or instructions refer to the Pressure Measurement User Manual GAIN amp SHIFT Adjustment and Calibration Each amplifier module and pressure transducer may be calibrated following the procedure given below 1 Using a Manometer an appropriate range and accuracy and a volt meter with a display of 10 000 and 10 000 volts DC to an accuracy greater than the pressure gauge accuracy Follow the ViVilest software calibration steps inputting range i e O 200mmHg recognition of atmospheric pressure voltage 6 0 volts adjust SHIFT as needed and recognition full scale voltage 6 0 volts adjust GAIN as needed NOTE To avoid poor signal to noise ratio and recording of erroneous data the full scale capability of recording instruments should be matched to the range of the dynamic signals to be measured Use a trim p
131. t is suitable to be viewed and manipulated within a CSV file reading program Data supplied includes trial and valve information as well as e Associated data creating the current trial scene e Raw collected Inflow Outflow pressure measurements throughout the displayed cycles To Save Open and Print Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 75 of 118 V V Pulse Duplicator System User Manual 1 Selecting the Export CSV button will capture the data associated with the Process Display area as it is seen on the screen save window will display to enable the user to customize the file name alternately the user can opt to use the automatically assigned file name created from valve identifier information data and time NOTE The CSV file will not open immediately but be saved to the Files directory of the software for later viewing 2 Access the file via Explorer under C Program_Files ViVitro_Labs ViViTest Files NOTE The file will be identified with CSV format The file name will be the identifier information entered for the valve and the date and time or the customized name the operator assigned 3 Open the desired CSV NOTE This will open within the computers preferred CSV file viewing program 4 Select print from the menu 10 25 ANA file During the Analyze Process an ANA file is created to store the save data collected The ANA file enables the operator to open the analysis information to allow co
132. tal regurgitation expressed as a percent of the total forward flow Closing Volume Leakage Volume FV Is defined as the volume of fluid that flows through a valve in the reverse direction during one cycle and is the sum of the closing and leakage volume expressed as a percentage of the stroke volume This assessment is conducted with sealing applied to the valve to prevent paravalvular leakage Is defined as the volume of fluid that flows through and around a valve in the reverse direction during one cycle and is the sum of the closing and leakage volume expressed as a percentage of the stroke volume This assessment includes both transvalvular and paravalvular leakage Effective orifice area determined by the Gorlin equation cm Opus s the root mean square forward flow mL s during the positive differential pressure period or Aortic or Mitral RMS Flow P in ViViTest Ap is the mean pressure difference measured during the positive differential pressure period mmHg or Trans Aortic or Mitral mean pressure P in ViViTest p is the density of the test fluid g cm Transaortic pressure Transmitral pressure AO Positive Pressure Document No 17473 V1 3 The AP across the aortic valve the difference in aortic and ventricular pressures The AP across the mitral valve the difference in atrial and ventricular pressures The part of a cardiac cycle in which AP across the aortic valve is positive ventricular pressure greater than
133. te These values are referenced to the ventricle pressure measurement site thus the ventricular pressure offset will be 0 0 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 47 of 118 V V Pulse Duplicator System User Manual 8 System Preparation for Calibration e Verify power is On for all instruments e Verify hardware and fluids o Pump head and VIA optional component are fluid filled and debubbled o Flow meter probe is in place and connected o Atrium Ventricle silicone ventricular membrane is in a static state Aortic Root and Aorta Chambers are fluid filled according to their specifications and debubbled Compliance Chambers are compliant Transducers are in place and connected Peripheral Resistance is connected o Heat exchanger is connected optional component e Verify electrical components and connections o Pump controller is turned on and desired waveform control is selected Ensure Limit is not illuminated if it is switch is moved in the direction of the arrow o Flow meter turned on MEAN is set to HI ground cable is connected to Flow Probe pin If the Alarm is illuminated depress and allow 10 minutes to stabilize It is recommended to set the Range to 100 and Hz Response to 30Hz o Pressure Amplifier turned on Low pass filter settings set to recommended 30Hz o Data Acquisition system turned on and ViViTest software loaded and running O O 8 1 Pump Calibration Operational Check e Verify
134. ted to the degree of acceptable resolution The data accepted should be reviewed to ensure the calibration specification meets the testing objectives Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 67 of 118 V V Pulse Duplicator System User Manual 10 6 Zero Calibration Measuring Sensor Zero References ero Zero offset measurement is the most common of the calibration processes and best practice is that this be done frequently within a valve trial session Zero values for the sensors are calculated for the pressure pump and flow sensors on a quiescent system open to atmosphere Users initially have the option of entering Known values directly into the editable fieldsin the Calibration Wizard or follow instructions given by the Calibration Wizard to measure zero voltage values using ADC input The software tracks the changes of transducer zeros against previously stored zeros These are indicated as the Drift value in the Sensor Calibrations panel NOTE Abnormal zero DRIFT may indicate a malfunctioning transducer 10 7 Finishing Calibration Updating the Calibration File Finished After all the calibration processes have been completed select the Finished button to save the calibration parameters regenerated in the wizard At this point you have the option to print the calibration report This will be saved in the Files folder as an htm file Whenever a new calibration is completed the file is rewritten and a n
135. that flow probe is oriented such that the side with numbers is the outflow side 3 Turn on SuperPump controller ampack and flow meter to allow electronics to come up to operating temperature 4 If required turn on the Heat bath to allow it to come up to required temperature Refer to Pulse Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 105 of 118 20 6 Calibration Start ViViTest software and open the calibration file that the software defaults to Click Click and follow prompts to take zero voltage reading of all channels Set up Pulse Duplicator for pressure calibration as per Pulse Duplicator User Manual Click land calibrate as per prompts Use a manometer for pressure reference ensure that calibration is valid Set up Pulse Duplicator for flow calibration as per Pulse Duplicator User Manual Remove all air from VIA if installed Follow Flow Measuring System setup instructions as per Pulse Duplicator User Manual tab a ee ZS Click and calibrate as per prompts 0 If testing on a new system for the first time or if displayed pump and ViViTest stroke volumes do not align a E 11 Click ae calibrate as per User Manual 12 Click and save calibration file as YYMMDD TP XX XX cfg renaming is optional 13 Turn off flow probe by turning Probe knob on flow meter to Off 14 To verify that the calibration was done correctly ensure the flow meter is turned on and the pre
136. 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 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 Requests to the Publisher for permission should be addressed to ViVitro Labs Inc 455 Boleskine Rd Victoria BC Canada V8Z 1E7 www vivitrolabs com info vivitrolabs com tel 250 388 3531 toll free 877 588 3531 fax 250 483 1975 Document No 17473 V1 3 ViVitro Labs Inc 2011 Page 2 of 60 V V Pulse Duplicator System User Manual Table of Contents Ms AOU VE OOS Len 9 tet Cautions ANG VV 11 ao EE 10 Tee ele tg Eg E 10 2 About the Pulse Duplicator System rnnnnennnnnnnnnnennnnnnnnnnnnnnnennnnnennnnennnnnnnnnnennnnnnnnnnennnnr 11 2 1 System Hardware 11 22 Hardware FC ANU SEE E E R E E ENE 11 23 VIVIT CSE Software EE 12 2A SE FANS gt 12 SEENEN 12 2 6 Software Requirements ccccccccccseccceeececececeeeeeseeeesseeeeseeeeseeesseeessueesseeeseeeesseeeesees 13 24 WUpg ade IMStallatiOn WMSUUGTONG sssaaa naa aAA AN 13 3 About the AR Series SuperPump rannxnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnennnnnnnnnnennnnnnnnnnennnnr 14 Se VS UCT WY lS esters cence sie sac O 14 SSC 14 3 3 SuperPum
137. the piston displacement piston displacement differentiated with respect to time dL dt and flow transducer signals Using the ViVilest software following the FLOW Calibration steps The phasing between these signals can also be determined If the electronic filters on the instruments are matched typically either 30 Hz or 100 Hz low pass filters then any measurable phase difference for these signals is likely due to the characteristics of the transmission path between the flow generator piston and the flow probe Always verify the flow zero reset electronically by following the software prompts for re zero Turn the pump controller amplitude to the desired pump stroke volume typically 70ml Verify the proper flow meter PROBE FACTOR value obtained from the manufacturer calibration label is set The system is now ready for flow calibration in ViViT est Document No 17473 V1 3 O ViVitro Labs Inc 2014 Page 53 of 118 Mi Vit Pulse Duplicator System User Manual 8 8 Calibration Preparation of Mitral Flow Probe The diagram below illustrates the proper set up for Mitral Flow calibration Stoppers may be used as shown in the diagram or the tubing can be clamped If the stoppers are used care should be taken to remove the tubing without damaging or breaking the acrylic hose barbs Potential sites for entrapped air must be removed Stopper Solid Rubber Seal Aortic Site Annular Rubber Seal Mitral Site Mitral flow calibratio
138. the power cord supplied with your SuperPump The controller must be plugged into a grounded outlet rated for 300W 3 9 Fuses Two fuses are supplied and required for the SuperPump Controller They are located in the fuse drawer on the power input module on the back of the controller At 230VAC use two 2A 5mm x 20mm 230V fuses At 120VAC use two 4A 5mm x 20mm 230V fuses Contact ViVitro Labs if you require replacement fuses Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 16 of 118 V V Pulse Duplicator System User Manual 4 Running the SuperPump System 4 1 Waveform Source The SuperPump may be operated using either a USB connection to a computer running ViViTest Software see ViViTest user manual b Internally stored waveform see section 8 ViVigen c Externally generated waveform If an external waveform is to be used plug an appropriate BNC cable from the waveform source to the Waveform In port on the back of the SuperPump Controller sec 2 4 The external waveform should conform to the following specifications e Amplitude 10 0 Vpp 45 0 Vpp maximum Any waveform that exceeds this amplitude will not be accurately represented in the pump movement e Rate Frequency 4 bom beats per minute minimum to 200 bom maximum 0 067 Hz to 3 33 Hz NOTE Do not input waveforms with frequency greater than the listed maximum e Form Bi polar The waveform should be centered about 0 V ground without D C offset unless o
139. the pressure transducer If this static head and atmospheric pressure do not change i e orientation of transducer and atmospheric pressure are constant then the reference pressure will be constant for each transducer NOTE With no flow of test fluid the pressure transducers will record the static head of pressure on the transducer sensing element This will differ from the static wall pressure by an amount equivalent to the head level difference between wall pressure measuring point and the sensing element To compute transvalvular pressure under pulsatile flow conditions compensation for the static head of pressure should be made This compensates the pressure transducers to a zero offset for differential measurement referenced as compensated pressure Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 46 of 118 V V Pulse Duplicator System User Manual Experimental Measurement e Experimental measurement of the compensation to be applied can be made with the same fluid head in the model above all pressure measuring ports e The ViVilest software handles experimental determination of the static head pressures as part of the pressure calibration routine e Alternatively these static head pressures may be manually input into the software When the test fluid is saline the approximate values to be input are 6 5 mmHg for the aortic pressure site and 0 2 mmHg for the straight left atrium or 3 5 for the angled rectilinear left atrium si
140. tle bar to write an HTML file to the Files folder Verify the data in the report review and either delete the HTML file or print to the system printer from a browser Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 73 of 118 Mi Vit Pulse Duplicator System User Manual 10 20 Review Process The Review Process allows users to browse acquisition ACQ files and quickly graph their pressure flow and differential transvalve pressure and power characteristics on a common timescale The list of current ACQ files is shown in a checked list in the Selected Files panel at screen right 10 21 I O Module Re initialization In cases where the I O Module needs re initialization the following sequence is recommended Remove the I O Module USB cable from the PC Wait 10 seconds and then re insert the USB cable to the PC Navigate to InstaCal icon on your desktop and double click Highlight the board number in the detection box and click OK Right click on the board number in the InstaCal box and select configure Confirm settings are set to a 8 differential channels Factory calibration c XAPCR Edge Rising d XAPCR Pin direction input e f pe XDPCR Edge Rising XDPCR pin direction input g ADC settling time 10us Click OK Right click on the board number in the InstaCal box and select Calibrate A D Click Calibrate 0 Click OK and Exit program mo i 10 22 Running a Report ViViTest reports capture a
141. tware in your business 3 establishing adequate independent procedures for testing the accuracy of the Software and any output and 4 establishing adequate backup to prevent the loss of data in the event of a Software malfunction 21 6 Limited Warranty Exceptions amp Disclaimers a Limited Warranty ViVitro Labs warrants that the Software will be free of defects in materials and workmanship and will perform substantially in accordance with the Documentation for a period of ninety 90 days from the date of receipt by you ViVitro Labs also warrants that any services it provides from time to time will be performed in a work person like manner in accordance with reasonable commercial practice ViVitro Labs entire liability and your sole remedy under this warranty shall be to use reasonable efforts to repair or replace the nonconforming media or Software or re perform the service If such effort fails ViVitro Labs shall i refund the price you paid for the Software upon return of the nonconforming Software and a copy of your receipt or the price you paid for the service as appropriate or ii provide such other remedy as may be required by law Any replacement Software will be warranted for the remainder of the original warranty period or thirty 30 days from the date of receipt by you whichever is longer b Exceptions ViVitro Labs limited warranty is void if breach of the warranty has resulted from i accident corruption misuse or neglect of
142. uage version of this Agreement shall be the authorized text for all purposes despite translations or interpretations of this Agreement into other languages If for any reason a court of competent jurisdiction finds any provision of this Agreement or a portion thereof to be unenforceable that provision shall be enforced to the maximum extent permissible and the remainder of this Agreement shall remain in full force and effect 21 9 Canadian Sales If you purchased this product in Canada you agree to the following The parties hereto confirm that it is their wish that this Agreement as well as other documents relating hereto including Notices have been and shall be written in the English language only Les parties aux pr sentes confirment leur volunt que cette convention de m me que tous les documents y compris tout avis qui s y rattache soient r dig s en langue anglaise You further agree that this Agreement is the complete and exclusive statement of your agreement with ViVitro Labs Inc relating to the Software and subscription service and supersedes any other agreement oral or written or any other communications between you and ViVitro Labs Inc relating to the Software and subscription service provided however that this Agreement shall not supersede the terms of any signed agreement between you and ViVitro Labs Inc relating to the Software and subscription service ViVitro Labs warrants all parts of its own manufacture to be free from defe
143. ule NET 3 5 framework 2 5 Hardware System The ViViTest software is shipped pre installed on a PC Components e Laptop or Desktop PC with monitor keyboard and mouse e UO Module NET 3 5 framework The ViVilest software application is designed to run on the following minimum hardware specifications e LCD monitor capable of 1600 x 900 resolution High throughput video card I O Module 2GB RAM 38GB Hard drive Pentium 4 3 6 GHz Processor single core or better Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 12 of 118 V V Pulse Duplicator System User Manual 2 6 Software Requirements For the software to run smoothly the following software is required to be installed on the computer e Microsoft Windows XP Professional SP3 Windows 7 Windows 8 e NEI 3 5 framework 2 7 Upgrade Installation Instructions As the software upgrades are released you will be notified via email Instructions 1 Download updater installer file 2 Select the single comprehensive installer executable 3 An installation Wizard will guide you through the installation steps 4 Unless provided the installation key should be left blank NOTE With some upgrade releases there may be the necessity to upgrade the I O Module files and or the NET files The Wizard will guide you through this Should you incur problems contact ViVitro Labs directly Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 13 of 118 V V Pulse Duplicator System User M
144. up by selecting the checkbox Ge next to the file name IN the Analysis Files list Disk IC sl C Program Files YWiVitro Labs WiviT est e repeat the steps above to create another group NOTE If the groups tree need to be cleared select the Clear H 10084 ANA 06 29 2007 CI bot op 05 07 2010 button Al MI Copy 2 of 0041 02 Fi 02 09 2010 H Copy 3 of 0041 02 Fi 02 09 2010 Mi Copy 4 of 0041 02 Fi 02 09 2010 Mi Copy of 0041 02 08 Fi 02 09 2010 oO Group op Fil 03 19 2010 of Group1_resOO000000 Fi 06 23 2010 O Group2 arp i 04 28 2010 Oo Trial 1049 03 19 201 Fi 03 19 2010 OM Trial 1049 03 19 201 Fi 03 19 2010 Save the group using the save button a and enter a file name in the Save dialog box The new groups file appears as a GRP name in the Analysis files list 10 18 Auto scaling and Zooming When users select a different Y graph type or change the data type selection shown in the X or Y axis the graph is auto scaled to fit the data before it is rendered Users can override and adjust this auto scaling using the ESS zoom buttons for either axis 10 19 Handling Compare Results TI Export CSV To put the list of trial means being compared into an editable file for off line analysis select the Export CSV button this creates a comma separated value CSV file Print Report Users can create a report of the Compare means by selecting the printer icon in the ti
145. w meter signal to equal the pump dL dt If a significant drift is noticed in the flow meter conversion factor the flow meter and probe may require calibration Three zero crossovers for each signal should be seen on the voltage graph on step three of the Wizard within the Process Display area Where this is not the case an error window will appear to run the user through the process again A typical Pulse Duplicator System configuration consists of a single flow sensor so dL dt is the default selection meaning that overall system flow is calculated using the pump s RPM sensor and that flow at the un instrumented side of the model will be indirectly derived from both Channels 4 and 5 Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 63 of 118 1 Vitro oa m mj EN H a bh Flow Calibration gt lt gt fam rt a sn on R ge 8 8 pg n e 7 PLP pe yn om S ase n pon Stop unplug the pump Drain and remove chamber opposite the flowmeter from beer Gre SAT TN Ep DPN eee eee SG EE Mg fe system typically aortic chamber Replace valve gasket with solid valve plug and fill with test fluid so no air is trapped below plug Is plug in place and filled with fluid 1 Set Pump Control settings on the right to desired levels Typically users would use a cycle rate at 70bpm using a sine waveform of 50 A sine wave is required for accurate flow calibration 2 Click Flow under calibration stage on left
146. y is the menu knob which allows scrolling by turning the knob and selection by pressing the knob To the right of the display is the amplitude knob which adjusts the amplitude of the output waveform and starts and stops the pump by pressing the knob Document No 17473 V1 3 ViVitro Labs Inc 2014 Page 15 of 118 Vi Vit A O Pulse Duplicator System User Manual ADS Inc 3 7 Rear Panel The rear panel contains all of the connectors From left to right Waveform In BNC connector used when an external signal is used as the waveform Position BNC connector analog output signal for the piston position dL dt BNC connector analog output signal proportional to instantaneous flow rate Sync Out BNC connector 5V TTL signal triggered at the rising zero crossing of the waveform The timing of the signal can be adjusted to any point in the waveform Troubleshooting port no user accessible functions e USB For uploading custom waveforms created using ViVigen software or for use with ViVitest when the SuperPump is used as part of the Pulse Duplicator e Motor Cable connection to the pump e Cooling fan e Power input Power cord fuse holder and main power on off 3 8 Electrical Requirements ViVitro Labs Inc will endeavor to have your system s components adapted to meet your country s power supply however as an extra precaution it is advised that all equipment designated to be connected to a power supply be checked prior to use Use only

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