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HC-002 HiCycle User Manual

1. rasten ogies HTest st datafile sedis BTA ELI LIII HiCycle System User Manual Labs Hes Version 50 89 Running a Report reports capture snapshots ofthe data during a durability testing Results displayed on the report enable the user to identify the trial valve HiCycle Unit and selected value used for the trial A screenshot of the Process Display area is provided for visualization of the waveforms during the cumulation process Using the Print lean report is crested within an HTML document These fles are automatically saved ta your Fes folder within the software directory To print the report follow these Opening and Printing Report keep physical copy of the report users can 1 Access the via Explorer under C Program _Files ViVitro_Labs HiTest Flles NOTE The file will be identified with html format The fle name will be the identifier information entered forthe valve and the date and time 2 Open the desired report NOTE This wil open in a Browser or the computers preferred html viewing program 3 Select to print from the menu Reports can be created after key accumulation processes have been completed and saved The fies are saved after the accumulation process and by default are saved in C Pragram Fles Vviro Labs HiTest Files The tst fles be opened to analyze previously saved data accumulations whe
2. Controller Turm onthe controller rive set to Standby Amplitude set to Zero Temperature ls gt Verify that all connections are in place Commence Controller and Module operation Turn the heater on temperature wil rise to the preset e g 37 C 2222 Take the Controller out of Standby mode Increase the amplitude on the Controller to the desired level 5 Startthe computer and logon HiCycle System User Manual Labs HiTest Version 50 Open instacal Right click and select Remove Board Clk Refresh 10 1L Right Clik and Select Configure 12 ADC Settling Time to 10us 1 44 Cove Instacal 15 Double click onthe HiTest icon located on your desktop 16 Selectthe desired calibration configuration file Note The Demo Calibration fle installed in C Program_Fles ivitro_tabs MiTest Fles contains factory calibrations for the pressure measuring system These should be sufficiently accurate for exploratory use af the HiCycle System A checksum test will alert the operator should configuration become corrupted If this occurs ether substitute a backup file or copy the original fle from the distribution medium to the Files folder and overwrite he corrupt file The sensors should then recalbrated 17 Set up your session For each valve using the Valve Selection buttons on the left select the
3. Voltage 90 240 Temperature Ambientta 40 0 5 Dimensions Module on Cart 570 x SED 1320 mm Weight Module p Weight Controller can Take Environmental Operating Temperature 1010350 Operating Humidity 3510759 Operating pressure elevation 70 105 a Shippng Storage Temperature 2016 509 Shippng Storage Humidity Er No restriction on pressure during shipping storage vitro HiCycle System User Manual HiTest Version 50 17 Appendix G Tool List The following toos are required to operate AR System Al tools are provided with the system inthe Accessories Ki AR Series Tools Hex Key DSi Hex Key an Hox key 3 0 Hox key Trim Potentometer Adjustment Tool Philis Head Nat Driver ayain BA Vitro HiCycle System User Manual HiTest Version 50 18 Appendix Software License Agreement The terms and conditions that follow set forth legal agreement between you ether an individual or an entity and ViVitro Labs herein referred ta as ViVitro Labs with principal place of business at 455 Boleskine Road Victoria BC Canada VEZ 17 relating to the computer software known as HiTest and certain other related software Modules if applicable herein referred to as Software The term Software includes and these terms and conditions also appl
4. ORINGV TIDU EELA 5 Tubing w Luer Lock ends RE 0584 BELLOWS HORE 1 BA HiCycle System User Manual HiTest Version 50 15 Appendix Durability Testing Step By Step Guide 154 Scope This guide is intended to serve as a reference for testing once the user has already become familiar with the system through training and reading the user manual This test method describes the testing to be performed on cardiovascular implants or cardiac valve prostheses for evaluating durability The method may vary for diferent samples or test plans 152 Definitions Symbol Definition Bem Frequency of operation expressed in terms of beats per minute Deployed valve diameter Outer diameter mm of the implantable device when deployed within the target implant site in an idealized circular configuration This measure 6 the size used to determine minimum device performance requirements for transcatheter valves Accelerated wear testing wear testing beyond physiologic conditions e g best rates 2200 bpm Control valve valve with known performance used as a benchmark during wear testing Regulatory test A test conducted with the intent of submission to a regulatory body Le FDA CE The test should fully comply with al applicable regulations Tuning the system A series of fine adjustments to the accelerated wear testing System elements This is necessary to ensure accuracy and repeatability of th
5. This immediately cancels calibration mode without updating the Pressure Calibration Values Reduce to user moves through the calibration sequence the acquisition system Thumbnail Continues sampling voltages in the Background and shows these on the raph that is now behind the Wizard window Users can view the graph fully by collapsing the Wizard window down to a thumbnail in the lower left comer of the Hiest window Clicking on this thumbnail retums the Calibration Wizard window to its fll continue calibrating 83 Pressure Calibration The pressure transducers remain installed in the Scan Valve and can be calibrated in place The pressure transducers must be filed with fluid to be calibrated When pressure measurements are not being made Scan Valve should be aligned between chambers to minimize fatigue of the pressure transducers The HiTest software guides an operator through two point pressure calibration and static head calibration NOTE Re eroing of the transducers and re calibration ofthe pressure measuring system i required prior to accumulating dat 120 urnthe Controller on and ensure the amplitude is set toO Put the Controller in Standby mode 2 ign Scan Valve with chamber connected to the Pressure Head connection 3 Select the Calibration button fram the Toolbar Calibration can also be initiated 4 Selectthe most recent calibration file Vitro HiCycle System User Manual HiTest Ve
6. Compensation Spring Configuration 13 Appendix Alternate Pressure Head Configuration 14 Appendix D Recommended Spare Parts Kit 15 Appendix E Durability Testing Step By Step Guide 15 1 Scope 182 Definitions E 153 Summary of Tests ISO 5840 3 Annex 2 184 Equipment Required s 155 CAUTIONS m 186 Sotup 2 187 94 18 8 Baseline Assessment 55 189 Setup and Loading 2 Tune 96 18 11 ata Collection 56 18 12Dally Visual Inspection 87 Check 87 15 14Functional Evaluation 16 18Data Quality Assurance 18 16 oporiing 16 Appendix F Specifications 17 Appendix G Too List 18 Appendix H Software License Agreement 483 Grant of License 182 183 Responsibility for Selection and Use of Software HiCycle System User Manual HiTest Version 50 184 Limited Warranty Exceptions and Disclaimers 104 185 European Sofware Directivo 18 6 General Provisions 187 Canadian Sales 106 sedis BTA Wir a ae ESI BA Nitro HiCycle System User Manual Labs HiTest Version 50 1 About ViVitro Labs Labs nc offers industry leading cardiovascular test equipment and related laboratory testing services Hundreds of organizations in over 39 countries for 30 years have trusted Vitro expertise accuracy and quality for their cardiovascular device testing As the developer af the world
7. Draining Chambers 4o 89 Scan Valve Operation a 6 10 Caps 43 6 11 Debubbiing of Pressure Transducer Channels 45 HiCycle System User Manual HiTest Version 50 6 12 Compensation Spring Adjustment 46 7 HiTest Software Introduction 48 7 Soltwaro Interface Orientation 72 Top Level Toolbar 7 Support Information Area 52 7 Controls 53 75 Accumulating amp Resume Live Conto 53 78 Results Pane 53 7 Process Display 55 2 3 HiTest Software Operation Test Preparation 57 82 Calixation Wizard Navigation 59 83 Pressure Calibration 59 84 Sensor Static Head Zeroing 2 85 Module Tuning 2 B Accumulation Procedure Diagnostics TST Fies n 89 Running a Report n 810 Taking a Snapshot 78 8 11 Exporting CSV File Data 2 812 Log Files 76 System Maintenance Chamber Cleaning 78 92 Shroud Removal 78 93 Controller Cleaning 78 94 Bellows Replacement 78 95 Piston Alignment an 95 Pressure Transducer Replacement 80 10 HiTest 5 0 Release Notes Ti Appendix Valve Ring Molding and Mounting 11 1 Design and Fabrication Considerations HiCycle System User Manual HiTest Version 50 11 2 Molding Ki m 11 3 91 1100 Silcone Rubber Properties m 11 4 Mounting Ring Mold Assembly 11 5 Maing RTV Silicone Rubber 11 8 De Aarating and Dispensing Mixture 117 Mounting Ring Removal 12 Appendix Alternate
8. European Software Directive Ifthe 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 af an independently created computer program with the Software as permitted Under the Software Directive Interoperability Information vou must notify Vitro Labs in writing Specifying the nature of the Interoperability Information you need and the purpose for which it wil be Vitro Labs reasonably determines that you are entitled to such Interoperability Information under the Software Directive Labs Inc shall at its option either provide such Interoperability Information to you i allow you to reverse engineer the Software within the limits and forthe purposes prescribed by the Software Directive solely to the extent Indispensable to obtain such InteraperabltyInfermation Vitro Labs Ine elects clause 0 you wil provide any information and assistance reasonably requested by ViVitro Labs Inc to enable Vito Labs inc to perform clause 1 and Vivre Labs Ine may charge you reasonable fee for making available the requested Interoperablty Information unless such a fee prohibited under the Software Directive 186 General Provisions You acknowledge that the Software and the D
9. Manual Labs HiTest Version 50 thin layer of mold release eg Vaseline or wan should be applied before molding Experimental devices VSI BC bi lefit tissue valve can use a plastic rather than a fabric cuf This simplifies the design of the prototype valve and fabrication of both the mounting and rubber rings 112 Molding Kit A molding kit is supplied to assist in making rubber rings The standard kit consists of the following parts Leach molding jig components 18 pounds G 1100 Scone rubber cones nc Reach dispensing syringe enlarged end 35 mi 02 pounds GI 1100 Activator Silicones Ine Leach dispensing syringe ml standard dispensing syringe 35 ml desc gage tapered tip 5116TT 8 EFD Inc waxed paper mixing cup and wooden spatula Emi mold release grease Vaseline in syringe Optional acessories recommended for molding silicone rubber are given below These items may be obtained from the indicated suppliers 35 mifstroke hand operated vacuum pump capable af generating up to 25 inches of mercury vacuum P 79301 20 Cole Parmer nc Plexiglas vacuum chamber X inch LD tubing VC9991 Airpowered dispenser Contr EFD Inc Barrel reservoir pistons 5112CP B EFD Inc sr gas pressure input 80 100 PSIG gas pressure output 0 100 PSIG NOTE A standard hand operated 35 ml syringe may also be used rather than an air p
10. and Trial details according to What is required Gears the information in the fields of Trial Tale Trial Number and Valve 1D Pressure Sensor Table data extracted from the currently loaded calibration presenting calibration values Displays active calibration fle Analog Capture Variables Displays the mean values for the performance of the trial Hicycle Amplitude and Chamber Resistance fields are editable and require the operator to enter settings read from the Controller and Module respectively HiCycle System User Manual Labs HiTest Version 50 Valve Controls Toggle through valve data by selecting buttons Valve A to F Valve data displayed on the screen updating all fields and proces display graph for the valve selected One valve can be viewed at a time NOTE Operators are advised to correspond software lettering with the HiCycle chamber s reference letter When switching between different valves ensure the Scan Valve the HiCyele Module is collecting data from the corresponding valve chamber 75 Accumulating amp Resume Live Control Accumulating Selecting this will bring up a new window requesting a number of cycles you would ike to run in your trial This is used to demonstrate a direct Segment of the trials test by accumulating al data Once the rial is run through the option to save the data as esv appears The accumula
11. and the target pressure threshold against which valve performance is measured The calibration file being used and the date and time it was ast updated Alegend bar indicates the meaning of the various colored graph traces These be turned on off by clicking the text in the legend to simplify the display yi Nitro HiCycle System User Manual HiTest Version 50 RED ne Valve Outflow Pressure YELLOW line Valve Inflow Pressure BLUE line Transvalve Differential ORANGE circi Peak Differential Pressure NOTE During the free running acquisition phase dling voltages measured by the A D card are rendered as traces in the graph panel every Y second the default A D period or cycle During this perioda series of cycles result in the repetitive waveforms on the graph NOTE Except in test le review mode when the graph is static the pressure graph s redrawn according the A D period which defaults to 2 Hz The graph can be manipulated by the following controis I Refreshes reloads the data on the pressure graph Restore restores the graph to the default viewing seale Incresse Decrease zoom manipulates the scale cf the pressure axis adjusting the Yanis mmtig Volts enables the operator to toggle between mmHg and vols B increases decreases the cycles in view on the process display between a minimum of 3 and a maximum
12. corresponding valve chamber letter as found an top of the HiCyele Module which the Scan Valve is positioned then enter the data pertaining to that valve Tia tile Date automatic ial number 227 Fluid Density Temperature ss recorded on the Hicycle Controller or other calibrated thermometer HiCyce Unit number Cycles counter Enter the number af cycles displayed on the Counter af the Controller Operator iD Comments for reference Adjust Analog Capture Variables bottom right rive amplitude from the reading on the Controller amplitude contral yi Vitro HiCycle System User Manual Labs HiTest Version 50 Chamber resistance restrictor reading from the HiCycle Module for each valve loaded chamber 82 Calibration Wizard Navigation The calibration proces is a step by step sequence guided by the Calibration Wizard which explains each step of the process leading to measured offsets or gains for the system The pressure calibration values are shown inthe Support Information area on the right side af the HiTest sereen While completing the Wizard users accept or edit the current values read from the calibration file proceed to measure new values by following the Wizard Users loop back to the start of the sequence to recheck values Close window At any time during the calibration proces users abort by clicking the Cose button in the upper right corer af the Wizard panel
13. ensure valve placement is evenly balanced inside the tester Remove as much air as possible while fling the chamber with test lui Adjust spring compensation as specified in section 6 12 to ensure shaker plate is initially inthe middle ofthe shaker stroke Connect static head to chamber and filas specified in section 66 Open bypass flow controis Gradually increase amplitude to debubbling level This should be high enough to agitate of the system but not high enough to fully close samples With system in standby further remove in system by drawing fid out of the inflow port using a syringe and allowing air to enter the outflow port capturing the bubbles in the window Slowly reintroduce fluid into the inflow port allowing air to escape the outflow port Repeat steps 10 and 12 until al air is removed from the system Vitro HiCycle System User Manual HiTest Version 50 1540 Initial Tune The tuning process can be very diferent depending on the samples provided The following is outline af the general procedure tuning the HiCyce 2 a n Check that restitors are still open and that amplitude is at zero Ensure window screws have a uniform tightness among the various valves a torque wrench s useful but not necessary Move pressure transducers to the first chamber one inflow one outflow Ensure Hes is Ive and displaying pressures Set sampling rate according to test p
14. fail to cure such breach within fifteen 15 days of notice thereof Upon the termination ofthe license you wil prompti retum to ViVitro Labs or destroy copies of the Software Documentation covered by the icense as instructed by Vira Labs 183 Responsibility Selection and Use of Software You ate responsible for the supervision management and control of the use f the Software and output the Software including but not limited to 1 selection of the Software to achieve your intended results 2 determining the appropriate uses ofthe Software and the output of the Software in your business 3 establishing adequate independent procedures for testing the accuracy of the Software and any output and A establishing adequate backup to prevent the loss of data In the event of a Software malfunction Witro HiCycle System User Manual Labs HiTest Version 50 384 Limited Warranty Exceptions and Disclaimers Vitro Labs warrants that the Software will be free of defects in materials and workmanship and wil perform substantially in accordance with the Documentation for a period of ninety 0 days from the date of receipt by you Labs also warrants that any services it provides from time to time wil be performed in wark manner in accordance with reasonable commercial practice ivtro Labs entire lability and your soe remedy under this warranty shall be to use reasonable efforts repair or repla
15. helps to suppress the formation of bubbles caused by dynamic pressures which occur within the chambers 2 Note Note Note Note test fluid to the Pressure Head Assembly and purge the fom the catheter ine Turn the Scan Valve so that the transducer isset in between chambers This connects all afthe chambers through a passage in the scan valve Ensure the stopcocks connecting the Pressure Head Assembly to the chambers are open to low passage of fluid from the Pressure Head syringe to the chambers It may take few minutes for the Pressure Head on the one chamber to bleed into the other chambers through he passage in the Scan Valve Do not press the plug firmly into the syringe This could prevent the fluid from freely flowing into the catheter The level of fluid in the reservoir should remain constant Evaporation with the stopper on the reservoir should be minimal but check often and refil as needed If the reservoir level falls rapidi check the system for leaks Before opening any valve chamber the Pressure Head Assembly stopcock should be closed This Wil prevent fluid being expelled from the chambers by the Pressure Headin the reservoir When the scan valve pressure transducer is aligned with a chamber the chamber is isolated remaining chambers are connected through the passage in the Scan Valve HiCycle System User Manual HiTost Version 50 57 Debubbling Chambers 1 Before
16. in HiCycle and conduct tune check as outlined n section 15 13 Ensure valve opening is consistent with the high speed videos captured during the most recent hydrodynamic assessment 1515 Data Quality Assurance Due to the interactive nature of the the following are ideal goals however every test device is unique and may deviate Loo Lowstandard deviations in measurements 2 Tune states should follow a trend and should not have significant changes in tune state without physical explanations 3 pressure signals should be relatively re from noise which may indicate the transducers were not properly flushed 4 Hsimiar type and size af devices are being tested each device should have similar performance characteristics 1546 Reporting Record the folowing conditions and results Sections may vary depending on the test plan HiCycle System User Manual HiTest Version 50 Loo Create atest report 2 Include snapshot from high speed video of each valve at both full systole and full diastole 3 Include any relevant photos taken during valve inspection sedis TA SW a LIII Wit 16 Appendix F Specifications AR Series HiCycle System User Manual HiTest Version 50 Capacity samples Tes Valve Se Max diameter 35 mm Chamber Volume 380i Fate 500 1650 cycles minute Operating pressure head 0 65 TP Electrical Specifications
17. of many internal components of the HiCycle Module i rita f here signs of damage initiate a claim with the carier and inform Labs 33 Hardware Assembly This section provides the user with the procedures for the hardware assembly of the HiCycle System NOTE The installation site far the must have a properly grounded 90 240 VAC 50 5092 power supply and a sturdy table or bench if the optional Cart is not being used 1 Placethe Controller on the Cart shelf optional with the device s controls in the elevated position Ensure there is adequate ventilation and access to the power switch t the rear of the device itro HiCycle System User Manual HiTest Version 50 2 Pacethe Module on the top of the Cart optional carefulypostoning the unit over the dowel pin and bolt holes Orient the connector on the Module toward the front of the Car M ase 3 Use the two large thumb screws to secure device to the Cart Do not aver tighten NOTE mounting the Hiycl a bench THE HICYCLE MUST BE FASTENED TO THE BENCH USING THE THREADED ANCHOR POINTS ON THE BASE PLATE 4 Feed the pressure transducer cables through Scan Valve handle and strain relief hose BA Nitro HiCycle System User Manual Labs HiTest Version 50 Locate the Scan Valve handle two red thumb screws on the top af the module Offset the two white spacers to retain the Scan Valve handie as shown below then secure using the t
18. or other Physical damage Donat remove the cover from the electronic Controller There are no user serviceable parts inside nat use solvents on any componente Aways use the power cord supplied with the unit to ensure proper grounding Ensure the rear ofthe Controller is unobstructed to provide adequate ventilation The amplitude must be reduced to minimum before starting nial operation to prevent damage to the Module or test samples Mtis not recommended to run the system at greater than 1080 bpm 18 Hz due to loss of accuracy of pressure readings Changes or modifications to this instrument not expressly approved by Labs will void the product warranty and could cause safety issues yitro HiCycle System User Manual Labs HiTest Version 50 3 System Assembly Listot Components The following components should be identified on unpacking p Hicycle Module Sean Valve handle fied to top of Module MCyde Accessories Kit Pressure Head Assembly mounting pole syringe catheter tubing Controller unit 2 Control eabie Powercord HiCycle Cart optiona Two 2 large thumb screws optional Hyde Data Acquistion System optional VWitroLaptop with Hest Software AmPack Pressure Measuring System VO Module Connecting cables Stroboscope optional Manometer optional Vitro HiCycle System User Manual L ab
19. shroud as described in section 92 above Remove bit in the center of all pistons using 9 64 driver and remove pistons Loosen bolt at base of piston rods using 9 64 key Re insert a piston into piston cylinder and center with the three the plstic shim stripe that are supplied in the accessories kit The shims should be equally spaced by approximately 120 The piston spoke should be perpendicular t the flow restrictor channel The bottom surface of the piston spoke should be slightly above the top of the piston rod the piston rod so that the tapped hole in the top af the pistan aligns with piston center hole Tighten bolt at base of piston rod maintaining center alignment above Insert bolt with stainless steel lat washer in central piston mounting hole and tighten Remove shim strips Check that the piston moves freely as described in Section 4 3 Repeat the above steps for each pistan 96 Pressure Transducer Replacement In the event that pressure transducer calibration values begin deviating from historical standard values or erratic and noisy data observed the pressure transducers part number 06346 should be replaced When ordering new transducers from ViVitro Labs specify that the transducer being used in the Scan Valve unless the alternate Pressure Head Assembly configuration shown in Section 13 5 being used instali the Pressure Transducer in the Scan Valve HiCycle Sys
20. to match and seal the appropriate boundaries on the device The rubber ring should not interfere withthe action of the device being tested The considerations discussed here apply to the design af rubber rings Tor mounting mechanical ar tissue valves with or without sewing rings jig components far valves are shown colored in the folowing illustration The jig components can be separated and adjusted by loosening bolt and thumb screws D The custom pedestal Light GREY is attached to the base PURPLE with a bolt The pedestal can be the actual valve or a replica af the outer dimensions ta which the rubber ring seals It can be made of Delrin which has good mold release ability When a valve or valve component is used as a mold a thin layer of Vaseline coating 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 fow 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 tt is likely that the tissue will be damaged in the molding process and should therefore be cut away before molding stent having all component parts except issue can faciltate molding of complex shapes If porous fabric materials are to interface with the silicone rubber BA Vitr HiCycle System User
21. turning Scan Valve so that the Pressure Head forces fluid through the transducer and pressure channels The pressure transducers in the Scan Valve should only be capped with the Safety Caps provided The Safety Cap on the lower transducer can be removedi tightened by using a fiat blade driver as described in section 6 10 The driver should be inserted horizontally between valve chamber and carefully levered against a cylinder so that the blade moves the serrated clockwise to tighten or anti clockwise to loosen BE CAREFUL NOT TO OVERTIGHTEN Below is a representation of a normal pressure waveform left and a pressure waveform that has excessive due to air bubbles in the pressure transducer port right mmHg Transvalve Pressure Waveforms ER inira rad M M li 6 12 Compensation Spring Adjustment In normal operation there wil probably be a mean downward force the driver caused by two factors 1 Hydrostatic Pressure Head from reservoir 2 Greater mean closed transvae pressure than open transvalve pressure This asymmetrical load causes the mean postion of the shaker armature to change from the unloaded mean position This reduces shaker stoke capability and can be avoided by using spring compensation Aspringin the center af the shaker should be adjusted to compensate for asymmetrical loading 1 Tum Controller to Standby mode 2 Cose the pressure head stopcock BA Vitro H
22. unlock Tighten knurled knobs evenly for free movement of Scan Valve i Nitro HiCycle System User Manual Version 50 Ifthe Pressure Head does not appear to be reaching all ofthe chambers Le fluid does not seep out of any open stopcocks when the pressure head is connected and open the Scan Vale may be over tightened The Scan Vale may be checked for over tightening as follows 1 With no fluid in the test chambers attach manometer to the top luer fitting 2 Connect a syringe full af air to the bottom luer fitting of the same chamber With the scan Valve oriented between chambers attempt to pressurize the chamber to 100 with the syringe Ifthe chamber holds pressure with a leakage rate less than approximately 10 mmHg in 10 seconds loosen the knurled white thumb screws on top af the scan valve anti clockwise a few degrees each and repeat steps 1 through 4 Atter loosening the Scan Valve monitor the system for small leaks in the instance that the Scan Valve is over loosened If leakage occurs tighten as described in the directions above 610 Safety Caps As the Scan Vave is rotated away from each chamber low frequency transient pressures distinct rom chamber pressures may be generated and can damage the pressure transducers To attenuate these pressures the transducers are shipped with a unique Safety Cap installed see image below BA Vitr HiCycle System User Manual bs HiTest Versi
23. F have the Heater On switch in the out position Set the Standby switch to the standby position have the Standby switch in the pushed n position Temperature Controller Standby Frequency Amplitude c HiCycle System User Manual HiTest Version 50 Power On Off Cable to Module 7 Switch on the Controller using the rear panel power switch shown above 5 The Standby LED in the center of the Standby switch should be b The Module shaker should nat be moving 42 Heater Setup 1 Switch on the Omega Temperature Controller shown below by pressing the Heater On switch The pla wil Process Temperature Temperature Set point Heater On Ott Temperature Sot Point Up Down HiCycle System User Manual Version 50 2 _Setthe temperature set point displayed in C for the Module using the Up Down arrows on the Temperature Controller 3 Press the Enter button to set the temperature setpoint The green LED to the ofthe OUTL text on the temperature controller wil be illuminated when the system is heating The measured temperature should begin to rise toward the set point value 37 0 typically and the base plate of the test chambers should begin to warm NOTE The system will heat more efficiently if the Module shaker is operating while heating due to relation of the test fuid NOTE DO NOT attempt to repair any problems ar
24. Manual Labs HiTest Version 50 TT a lc sin eps ye ete B SSS SS io am 1x et con mi a rire son nme tert tt prede uj io esv data output 812 Log Files Asan ongoing background feature of HiTest lg files are created each time user instructs the software do an activity These fles can be accessed the C Program _Files iVtro_Labs iTest Fies Logs directory as fle Log files are for technical support purposes and are not intended to be used as a record for valve data Saving Opening and Printing LOG File 41 Selecting the Append button Ld wil capture the data associated with data at that specific A save window wil display to enable the user to customize the name nVitrO HiCycle System User Manual Labs HiTest Version 50 Aternately the user can opt to use the automatically assigned file name created fom valve Identifier information date and time NOTE The Jog fle wll not open immediately but be saved to the Files directory ofthe software tor later viewing 2 Access the le Explorer under C Program _Fles ViVitro_abs HiTest Logs NOTE The fle will be identified with format The file name wil be the identifier information entered for the valve and the date and time or the customized name the operator assigned a Open th
25. Vitro HiCycle System User Manual HiTest Version 5 0 HiCycle System AR Series User Manual HiTest Version 5 0 yi Nitro HiCycle System User Manual Labs HiTest Version 6 0 Viro Labs HiCyde System Designed and Distributed by Vitro Labs Ine BC Canada Disclaimer and Limitation of Responsibility ViVitro Labs Inc assumes no responsibility for any damage los claims which may result from a failure to follow the instructions contained in this manual Additional ViVitra Labs Ine assumes responsibility result of direct or derived injury data oss system malfunction which occurs at the fault of misuse alternation of the system or incorrect application of use so advised or directed by vivir Labs Copyright Copyright 2014 by Viro Labs inc Ali rights reserved Published by ViVitro Labs Inc Victoria British Columbia Canada Limit of Liability Disclaimer of Warranty While the publisher 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 fitnes far a particular purpose No warranty may be created or extended by sales representatives or wrimen sales material The advice and strategies contained herein may not be Suitable for your situation Neither the Publisher nor author shall be lable for any lo
26. ached The bath counter wil be incremented and contain the count af the total number of Batches since last reset The Grand Teal counter will contain the total count since last reset The Tatal counter wil be zeroed when operation is stopped When the preset batch count is reached the machine wil stop and wait for the next Start command Relay 1 tums off when Paused using olay 1 Fiag remains when Paused using Standby switch Ait HiCycle System User Manual Version 5 0 53 Default Rate Totalizer Display The Default Display shown below is enabled on power up 1 Upper display is RATE in cycles per minute R fiag is displayed adjacent to the rate field Lower display is nominally the current batch count TOTAL The total counter wili be zeroed When operation is stopped then resumed Pause made or Standby mode wil maintain the total T tlag is displayed below the total field The default lawer display may be altered see below MenuiAdvance Rate Display Total Display Stati Fi Batch F2 SiopEnterF3 Vit HiCycle System User Manual HiTest Version 50 54 Alternate Rate Totalizer Displays Grand Total Display Batch Count Display NOTE The Controller must be inthe stopped condition to change operation settings To display alternate count formats during Module testing 1 Grand Total Display The Grand Total counter displ
27. ade 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 Custom Pedestal or 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 The device can now be mounted in the silicone ring and installed in the HiCycie Module y Nitro HiCycle System User Manual Labs HiTest Version 50 12 Appendix B Alternate Compensation Spring Configuration The Hi Cycle MODULE is normally shipped with the compensating spring in PULL configuration This is recommended for valves mounted with outflow uppermost which is prefered for visualization of valve outflow dynamics In this PULL configuration the spring pulls upward on the pusher plate and counteracts the biased downward load on the plate due tothe mean closed valve load being more than the load when the valve is open The tension in the compensating spring should be adjusted by turning the nut with the 3 8 inch driver provided so that the mean pate position under dynamic conditions indicated by the monitor pointer is the same the static load plate postion In this way the shaker operates efficiently and creep driver coil suspension mechanism is minimized may be preferable to mount mechanical valves with inflow uppermost so that gravity assis
28. an take several minutes however this time can be reduced by providing multiple evacuation release cycles during the de seration process During this cycling proces he 24 inHg 610 mmHg vacuum condition should be maintained for about 2 minutes Using this method the total de aeration time should be about 10 HiCycle System User Manual HiTest Version 50 5 1 Release vacuum and remove the from the chamber Pour and spatula the mixture into 30 mi barrel ez HS112CP 8 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 and set pressure to 40 psig 2069 mmHg Sly inject the mixed silicone rubber into the cavity being careful to avoid the formation of air bubbles or entrapment o air Allow the rubber to flow around the cavity The time to fil the cavity with rubber should be abaut 10 minutes Allow the rubber to cure vulcanize for 16 to 18 hours at 25 Lower temperatures and or low humidity wil cause the cure time to lengthen Conversely higher temperatures and or high humidity will cause the cure time to shorten 317 Mounting Ring Removal n 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 bl
29. and default of Help The user manual can be downloaded by selecting Browse User Manual under the Menu Bi button The user wil be directed to download link on the Vitro Labs webste For any further questions contact ViVitro Labs directly com Vitro HiCycle System User Manual Lab HiTest Version 50 8 Software Operation Before using Hest verity that the Software and Data Acquisition System optional are functioning peopely 1 Start the computer and logon 2 Prepare the HiCycle Unit for operation see Section 4 3 Verify the software installation and the hardware function by Positioning the HiCydle Scan Valve to a desired chamber Set HiCyele Controller to standby and temperature control to off Select the Hest icon on the desktop to launch the Hifest software Select the factory settings configuration cg Verify that the Drive Cycle Rate displayed under A D Acquisition Status within the software corresponds approximately to the DRIVE FREQUENCY value displayed onthe front Panel of the Controller The system is now ready to monitor the operation af the H Cyde System using HiTest Software 4 Preparation Before beginning calibration and testing prepare the system as follows 1 Hcycle Module for operation with valves as per section 4 2 Posion the Scan Valve to the desired chamber 3 Prepare the
30. as selected lower pressure reference specified in Step 25 4 prompts the user to pressurize the chamber to the previously entered upper pressure reference limit typically 200 mmHg using a manometer as a reference Vitro HiCycle System User Manual Hes Version 50 5 Step Sof S displays the newly calculated pressure calibration values in mV mmHg A warning wi be displayed if the gains deviate by gt 1 m mmHg and offsets deviate by 15 mV from previous calibration values NOTE The warning may appear if new system components have been installed Ifthe warning appears when components haven t been replaced repeat the calibration If the waming persists consider replacing the pressure transducers See section 9 6 The user can dick Proceed to accept the values click Repeat to calibrate again A HiCycle System User Manual HiTest Version 50 The Calibration Wizard wil then proceed to the Sensor Static Head Zeroing portion af th calibration B4 Sensor Static Head Zeroing Zeroing captures the static head pressure difference between the outflow and inflow sensors caused by her diferent vertical locations The chamber fluid column that sits above the sensors i first opened o the atmosphere with the system static and then outfiow inflow sensor readings taken Re establishing statie head sero offset measurement is the most common of the calibration processes and best practice require
31. ays the total count in thousands since the last reset It can initiated as follows Press Stel once to display Grand Total in thousands Gtotal text is displayed momentarily then the current Gr GT fag is displayed below the count field The Grand Tatal count in thousands wil be displayed during operation 2 Batch Count Display Total count in thousands The Batch Count counter displays the tatal number of cycle batches completed since last reset based onthe Batch Count Preset Batch Count counter can be initiated as follows HiCycle System User Manual HiTest Version 50 Press Stp ito display current Batch count bCount text is displayed The Batch count will be displayed during operation 55 Batch Counter Prese Move Right Enter NOTE The Controller must be the stopped condition to change operation settings When in operation the Module wil continue ta run until the Batch Counter Preset value has been reached Once the Batch Counter Preset number of cycles is reached the Module wil stop and will not continue operation unti the next Start command The Batch Counter Preset display can be initiated as follows 1 om the default display press three times to display batch count preset value in thousands PrESET text displayed momentarily then the current batch Preset value 2 press to display batch count preset in thousands 3 Press to increment current
32. can be saved by clicking the csv save button ana a hum report can be saved by clicking the mi report button 30 After reviewing the Data cick Save Data and Resume to save the accumulated data as tst fle and resume Live Running mode A dlalog box wil appear asking he user ifthey wish to save the data If yes is selected another window will open allowing the HiCycle System User Manual Labs HiTest Version 50 user to save the data collected Alternatively the Save button can be clicked and the Save Data Resume button wil change to Resume Live NOTE The software automaticaly creates fle name according to entered identifiers date and time 11 open a previously saved accumulation lic the open button NOTE Before opening a previously saved accumulation any unsaved accumulated data should saved to prevent loss of data After opening a file the user will have the opportunity to create reports or export csv files before resuming live acquisition Repeat the process for each valve mounted within the Module 87 Diagnostics When viewing tst fles in text viewing program such as notepad they display two lines of diagnostic information for the accumulation see Section 88 below Warnings wil also be displayed when pening the tt file in Hiest to alert the user i either of the agnostic criteria are detected Diagnostics missed Sean packets during accumulation with Sam
33. ce the nonconforming media or Software re perorm the service such effort falls Vitro Labs shall refund the price you paid for the Software upon return of the nonconforming acd s ty acit to kes you pad for i sari ax spec ort provid such other remedy as may be required by law Any replacement Software wil be warranted for the remainder of the original waranty period thirty 30 days the date of receipt by you whichever is longer b Exceptions Vitro Labs limited warranty is void if breach of the warranty has resulted from accident corruption misuse or neglect of the Software i acts or omissions by someone other than ViVitro Labs ii combination of the Software with products material software not provided by Labs not intended for combination with the Software or iv failure by you to incorporate and use all updates to the Software available from Labs Labs does not warrant that the Software service will meet your requirements or that the operation of the Software will be uninterrupted or errar free Limitations an Warranties The express warranty set forth in 18 4 is the only warranty given by Labs with respect the Software and Documentation furnished hereunder and any service supplied from time to time Labs and its licensors to the maximum extent permitted by applicable Iaw make no other warranties express implied or arising by custom or
34. ch drives the Module and can provide the link to the Hest monitoring Sotware Vitro HiCycle System User Manual HiTest Version 50 Hoye AA Sree Harare cpio Mx amt Cor Optional components Hicycle Cart Houses the Controller and Module at a convenient working height Stroboscope Allows user to view valve operation while testing at high cycle rates Digital Manometer Used for system pressure calibration oa Data Acquisition System Comprised of the AmPack Module and Laptop with HiTest Software the Data Acquistion System complements the HiCyce System by monitoring and recording pressure data BA Vitro HiCycle System User Manual Labs HiTest Version 50 te at Anak ria nd VO Mie yi Vitro HiCycle System User Manual Labs HiTest Version 50 2 Cautions Caution should be used when lifting the Module Injury can occur from improper lifting of heavy loads Do not it or move the Module by handing the top plate This can result in misalignment of the system NOTA LIFT POINT The Hicyele Module must be fastened to the mounting location optional cart or secure bench using the threaded anchor points the Module base plate The should be returned to ViVitro Labs in the case of the unit being dropped
35. chamber window See Section 12 f r more information Vitro HiCycle System User Manual Labs HiTest Version 50 Inset the silicone ring fitted with test sample into the piston cap ensuring the edge ofthe lione ring is held securely underneath the retaining ring Tur the assembly over to check the ring is concentric with the cap Adjust if necessary 5 Place cap assembly on the piston mount aligning the two bolt holes with the threaded holes in the piston 6 Check pistan and cap are concentrically aligned 7 Insert two bolts into the cap and tighten using a 5 64 hex key NOTE Take care not to scratch the TEFLON chambers coating on the heater plate at the bottom of the test Fluld Requirements Sterle water or saline 0 9 by weight recommended is a recommended test solution An appropriate to reduce the bioburden impact of contamination may be needed Contact supplier for a biocide recommendation and verify that it is compatible with the test chamber materials Teflon Aer Silene rubber rubber and 316 Stainless Steel Approximately 18 liters of fluid 280m per chamber are required to fil the system 65 Filing Chambers All chambers must be filed with fluid when testing Chambers without test valves must be filed with fluid that air is not drawn through these chambers nto the Scan Valve See section 64 for fluid requirements NOTE Before filing chambe
36. debubbling ensure the scan valve pressure transducer is not aligned with a chamber The postion of the scan valve should be as shown below Ensure that all three chamber uer fitting ports on chambers are close 3 flow restrictors 0 Turn the controller on and press the button and press the Standby button to release from Standby mode 5 Increase the amplitude slightly unti the piston caps are visibly moving 6 Using the Frequency dial cycle through the full range of frequencies until bubbles are no langer being dislodged 7 Press the Standby button to pause the Module and turn the Amplitude 0 3 Attach a syringe containing approximately 10 ml test fluid and no air to the bottom stopcock and apen the stopcock 9 Ensure the pressure head stopcock is closed yi Vitro HiCycle System User Manual HiTest Version 50 30 Remove the top luer fitting cap to open chamber to atmosphere 11 withdraw approximately 25 mi fuid so that all of small bubbles beneath the window are captured by the drawn in air Slowly push the plunger of the syringe into expe all air through the upper port Be careful to not introduce any new sr bubbles tote chamber from the syringe Replace the fitting cap onthe top 14 Close the stopcock on the bottom drain port and remove the syringe NOTE The above steps may need to be repeated several times before all chambers have a minimal a
37. digit The digit value wraps from 9 back to O and then 4 Press ta move the edit feld one character to the right The edit field position wraps rom the right most character to the left most character 5 press Stap ani P to enter the batch counter Preset value and return to the default display HiCycle System User Manual HiTest Version 50 5 6 Counter Reset Functions MenuiAdvance Batehi F2 StopEnterFs The counter display can be reset as follows 1 Press MSS to enter menu then BEFA display 2 Press Stop i F3 to select then press until Reset Grandtotal St Gt heading is displayed with SET on line 2 3 Press cycle through ESET t reset ESET Gt reset Grand Total ESET be eset Batch Count reset H reset display not applicable in this application reset L reset min display applicable in this application reset HL reset max and min displays not applicable in this application Press to return to the default display without performing a rest Press to reset selected counter and return to main display 6 Repeat steps through to reset another counter MA Vitro HiCycle System User Manual HiTest Version 50 6 Module Operation 61 Chamber Window Removal The windows can be removed with or without fluid in the chambers 1 tthe system is filed with fluid close t
38. dings The Amplitude dial sets the drive level af the Module which increases or decreases peak to peak movement of the chamber pistons and thus the pressures The Amplitude contral should be used asa tool for setting the chamber pressures and not the absolute drive plate peak displacement The relationship between the Amplitude control number and test chamber pressures or the piston displacement is not absolute but dynamic asit depends on several factors including 4 Frequency setting Offset setting o Restrictor valve settings Forward and backward resistance determined by diameter type number and mix of valves under test HiCycle System User Manual HiTest Version 50 For a given HiCycle system the Amplitude setting should be repeatable between test sessions if other dependencies are also duplicated The Amplitude setting should also be similar between AR systems if all conditions are the same WARNING The Amplitude must be reduced to minimum before Starting operation for the first time prevent damage to the Module or test samples once Module tuning has been completed see section 8 5 t still good practice to reduce Amplitude to O before restarting after a Pause or Stop event to reduce the possibilty of transient When stopping or pausing and restarting the HiCycle AR operation Pause or stop operation Note the Amplitude setting Reduce Amplitude 0 Restart operation G
39. e desired Jag file NOTE This wil open within the computers preferred Jog fle viewing program a select to print from the menu yi Vitro HiCycle System User Manual HiTest Version 50 9 System Maintenance 9 Chamber Cleaning The chambers be cleaned by soaking with mildly soapy hot water approximately 48 degrees Celsius and flushing with freshwater several times to clean soap residue from the chambers More thorough cleaning may require Module disassembly NOTE KEEP ORGANIC SOLVENTS AWAY FROM THE SYSTEM AT ALL TIMES NOTE DO NOT DAMAGE TEFLON COATING ON THE PLATE LOCATED AT THE BOTTOM OF TEST CHAMBERS 92 Shroud Removal To acces the bellows and piston rods remove the shroud around the Module Remove 9 upper and 9 lower Philip s head screws attaching shroud to Module Loosen 2 Philip s head screws on eft of Module panel Move end of shroud away panel Tighten 2 panel screws to maintain pane alignment Loosen 2 Philip s head screws on right side of Module panel Side end af shroud away from panel Remove shroud Controller Cleaning To clean the Controller case use a dry cloth Ifthe case cannot be cleaned by dry cloth then disconnect power and use a damp cloth to wipe the exterior of the case Use caution and do nat allow liquids to enter the controller case 94 Bellows Replacement t is recommended that bellows are replaced every 50 100 milion cycles Should bellows need replaceme
40. e test conditions from run to run Tissue Annulus Diameter TAD Diameter in millimeters of the smallest flow area within he patient valve annulus This measure isthe size used to determine minimum device performance requirements for Surgical and mechanical valves TransvalvularRegurgtant Fraction Is defined as the volume of fluid that flows through a valve in he reverse direction during one cycle and is the sum of the closing and leakage volume expressed as percentage of the Stroke volume This assessment is conducted with sealing applied to the valve to prevent paravalvulr leakage Vivitro HiCycle System User Manual HiTest Version 50 Total Regurgtant Fraction ls defined as the volume of fluid that flows through and around a Nominal Conditions Sand 95 rule 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 paravalular leakage Test parameters used for acceptance criteria listed in ISO 5840 Consisting af 5 LPM at a beat rate of 70 BPM and stroke volume of 75 mL sroke with 38 systole duration Targeted pressures across the closed valve were attained for at least 5 of each cycle during at east 95 of al test cycles 153 Summary of Tests 80 5840 3 Annex During drabliy testing devices willbe in a durability tester at an accelerated rate A
41. east 95 of the test cycles should be performed This shown in the Peak Pressures Meeting Target feld These results are shown in the printed report for the trial Also shown is the mean Peak Differential Pressure value and deviation AD Acquisition Status Displays the tria s drive rate and how many samples are run per eyele A D Acquisition Control Manipulate the A D sampling rate by toggling up or down to the desired value The Synchronize Mile button should be clicked when the Sampling Rate has been adjusted and when the Frequency has been adjusted on the Controller The Sampling Rate an be adjusted between 1200 and 4000 Samples second sampling rate of 4000 samples second is recommended there is a mismatch between the sampling rate on the controller and in HiTest increase the sampling rate and click Synchronize NOTE software timer whose default rate is 2 determines how often the A D card is instructed to perform an update NOTE The acquisition rate default 4000 defines how quickly data s digitized for each of 3 channels in a simple outfow inflow syne system and thereby the resolution f the digitized waveform 77 Process Display The Process Display shows the information being read by the system including 4 Most recent pressure sensor values for most recent ADC analysis Multiple valve cycles lt of horizontal lines show the 0 pressure voltage axis
42. ere is adequate storage space on the computer hard drive to prevent loss of data 1 Rotate the HiCycle Module Scan Valve to the desired chamber yi Vitro HiCycle System User Manual Labs HiTest Version 50 Verify that all information entered in the Session Information area is correct Ifthe warning below is displayed during Live Running increase the Sampling Rate in the A D Acquistion Control area and click Synchronize HiCyde 6 Anew window will appear asking the user far the number of cycles to be accumulated The number of cycles to be accumulated must be between 100 and 100 000 Click OK Progress of the accumulation is indicated at the bottom of the Process Display area NOTE Should the user wish to abort the accumulation Click the Stop Accumulate button cick No to discard the accumulated 7 ithe warming shown below i displayed at the end of the accumulation cycles increase the Sampling Rate in the A D Acquisition Control area and click Synchronize The accumulation must then be repeated The warning wil appear each time 157 file containing an erroris opened The following errors occured during accumulation Missed Packets es eire some emen 8 Once the accumulating is complete information window will appear prompting the user to static test data from the accumulation Click continue to view and save the data 3 While viewing the data a csv file
43. es an elecro dyrami shaker to drive 6 pistons within fluid filled temperature controlled chambers The pulsatile flow exercises mounted heart valves or specimens at an accelerated fate of up to 1 650 cydles minute Clear viewports on each chamber allow imaging of the valves during testing Pressure transducers allow monitoring of the dynamic pressures up and down stream of the valves with the use of Hest Software The ViVitro Labs Inc Series System s features include Simultaneous testing of2 3 4 or samples Adjustable cycle rate from S00 t 1 650 eeles minute Independent but not simultaneous monitoring of each sample chamber for Inflow outfow and trans valve pressures individual flow control for each sample chamber Sample observation and ilumination using a stroboscope through nan dstoting viewports Sample positioning locating without major disassembly exible sized sample mounting using adapter rings upto 50 mm in height and 35 mm in diameter Controlled temperature from ambient to 408C 05 C Grand Total Total and Batch Count functions Custom designed cart allow the equipment to be free standing and mobile Fd contact areas made of corrosion resistant materials Pressure Head to the sample chambers ranging from O to 65 mmHg 8 7kPa The System is comprised of Atest Module Drive Unit which creates pulsatile flow through up to 6 test samples An electronic Controller whi
44. he head pressure stopcock to prevent spilling If there is fluid in the system proceed to step 5 2 Attach a syringe to the bottom drain port stopcock Open the chamber to atmosphere by unscrewing the top fitting Remove a small amount or desired of the from the chamber using the syringe on the bottom drain port to prevent spiling during window removal 5 Loosen the two bolts securing the white window retention clamps with 23 32 driver and turn the white clamps untithe window is unobstructed NOTE One red thumbscrew is located on the top housing af the MODULE unscrew this to use handle to remove the chamber windows yi Vitro HiCycle System User Manual HiTest Version 50 6 Screw the red thumbscrew into the pre tapped hole in the chamber window Light tighten just touches the bottom of threads 7 Remove the luer cap from the top drain iit has not yet been removed 3 Gently pull window upward from chamber 52 Chamber Window Insertion Chamber windows can be inserted as follows E 2 Open the chamber to atmosphere by removing the top fitting Place the window on test chamber with the threaded hole facing upward The threaded hole must be facing upward during installation or window removal wil be very dificult careful Tot to pinch the O ring when pushing window into its seated position 3 Turn white window retention clamps ove
45. he screwdriver in the grooves of the Safety Cap fiting itro HiCycle System User Manual L HiTest Version 50 sn the screwdriver as a lever against the chamber and tum the Safety anti clockwise to loosen it from the pressure transducer Ifthe positioning i making this difficult reposition the Scan Valve and repeat The Safety Cap can be replaced by threading it onto the pressure transducer using the technique described in step 4 above and turning the Safety fiting clockwise to tighten BE CAREFUL NOT TO OVERTIGHTEN Debubbling of Pressure Transducer Channels Ay air bubbles in the pressure transducers in the channels from the transducers to the test chambers wil compromise the fidet af the pressure records Hidden bubbles may e evident from the oscliatory character of the pressure record see image below The best practice to ensure pressure measurement accuracy is by removing bubbles in the following manner Close the Pressure Head stopcock Turn the Scan Valve align with a chamber Attach a fid filed syringe to the bottom stopcock Remave the Safety from the transducer Fush the transducer and ines by injecting fluid into the chamber using syringe Replace the Safety Cap itro HiCycle System User Manual Labs HiTest Version 50 7 Open the Pressure Head stopcock NOTE An alternate way to de bubble pressure transducers is by removing the Safety Cap and then
46. iCycle System User Manual HiTest Version 50 3 Remove the scan valve handle 4 lease spring compression by turing nut in center of Module by tuming anti clockwise with the socket driver provided in the accessories kit Note alignment af Pasion Monitar indicator relative to the center of the Position Monitor window on the Module 5 Adjust H Cydle to dynamic operating conditions 7 Rotate nut so the Position Indicator ascites about the center of the Position Monitor window NOTE Adjustment of the compensation spring may change shaker peak to peak amplitude Therefore ransvalve pressures may need to be re adjusted to achieve target conditions after adjustment ofthe compensation spring NOTE When the driver is at rest for extended periods of time the compensation spring compression shouldbe released to maintain the relaxed condition of the driver suspension mechanism Vitro HiCycle System User Manual Labs HiTest Version 50 7 HiTest Software Introduction is designed for periodic monitoring acquisition and analysis of data generated during testing of heart valves over several milion cycles The software consists of two primary processes waveform acquisition and statistical calculations based on the acquired waveforms HiTest Hardware Requirements The Hitest software application is designed to run on the following minimum hardware specifications ICD monitor capable of 1600 900 resolution High
47. iCycle System User Manual abs HiTest Version 50 Density Puid Temp Current Cycles Counter Operator ID Record the following in lab notebook if not already done Test luid used and relevant parameters if specified inthe test plan viscosity and density Temperature of test Ensure Amplitude and Restrictor position are recorded Once data is collected save in desired test folder Capture valve opening using a high speed camera Save videos in desired test folder Ensure data is being backed up as appropriate 1542 Dally Visual Inspection This is conducted daily unless otherwise specified in the test plan 1 2 Remove any accumulated air from the test chamber Using straboscope check devices for any accumulated damage Any observations should be recorded A flash ight may also be useful to identify wear Ifin doubt use high speed video to characterize the damage Record the inspection with date temperatur cycle rate number of cycles name and task completed or as specified by the test pan 1513 Tune Check Measurements are conducted to ensure valves are meeting the S and 95 rule Checks are to be conducted every 10 milion cycles or as specified in the test plan 2 Move pressure transducers to the first chamber one inflow one outflow Ensure Hiest ve and displaying pressures Set sampling rate according to test plan the default 4000 samples sec Set numberof cycle
48. ising from insufficient heating If the temperature does rise discontinue use power dawn the system and notify Vitro Labs the temperature displayed on the controller varies by more than 10 C when measured with calibrated thermometer or when the temperature set point has been changed the Auto Tune heating function must be set Set the Auto Tune heating function as follows 1 Press the Enter button The display screen v ll read 2 Press the up arrow to display At or Press the Enter button to select Aton 4 Press the Enter button again to return to the temperature display screen The green LED to the left of the symbol should now be ashing 8 The system will heat until the temperature has stabilized at the set point When the Auto Tune process is complete the green LED to the left of the symbol will turn off NOTE When the temperature set point is changed the Auto Tune function must be set again BA Vitr HiCycle System User Manual b HiTest Version 50 Piston Alignment Check Alignment ofthe pistons within the test chambers s tal NOTE pistons are misaligned they may rub excessively against cylinder walls This may affect the driver operation and or cause damage to the There is a minimum clearance between he piston and cylinder wall Improper alignment should be checked foras fellows Remove all chamber windows ee section 6 1 Turn o
49. lan the default i 4 000 samples sec Set number af cycles in view to allow for appropriate love of cyce detail Fush transducers with syringe to remove any air bubbles The pressure tracings should have a relatively smooth trace with minimal high frequency noise Press standby button to start machine Gradually increase amplitude desired opening is achieved using a stroboscope This willbe based on the opening during zero cycle hydrodynamic testing Turn the flow restrictor until test plan differential requirements are met for the 5 and Recheck valve opening performance increase amplitude if required Repeat untl requirements and valve opening are acceptable Repeat steps 7 through 10 far remaining chambers until check revels that all chambers at desired conditions and no further modifications are required Capture data and videos using data collection section 15 11 Reset counter after initial tuning and set batch count if applicable Record the number of cycles accumulated during tuning in the lab notebook After the completion ensure data is backed up 1541 Data Collection This section describes the process for testing a single valve This will have to be repeated for each valve in the durability tester n on desired chamber letter corresponding to where the pressure transducers are locates Filin session information in Hest Tal Tite Number Valve we re H
50. langue anglaise You further agree that this Agreement is the complete and exclusive statement of your agreement with Vitro Labs Inc relating to the Software and subscription service and supersedes any other agreement ral or written or any other communications between you and ViVitro Labs nc relating to the Software and subscription service provided however that this Agreement shall not supersede the terms of any Signed agreement between you and Labs Inc relating to the Software and subscription service Labs warrants all parts of its own manufacture to be free from defects in material and workmanship under normal use service ina suitable environment fer the period af one year after delivery
51. mber of licenses you have purchased then you must have a reasonable mechanism or process in place to assure thatthe number af computers on which the Software is running cancurrently does not exceed the number of licenses purchased Vitro Labs reserves the right ta embed a software security mechanism within the Software to monitor usage ofthe software to verify your compliance with th licenze Such a security mechanism may store data relating tothe use of the Software and the number of times it has been copied Labs reserves the right 10 use a hardware lock device license administration software and or license Authorization key to control access to the Software You may not take any steps to avoid defeat the purpose of any such measures Use af any Software without any required lack device authorization key is prohibited Ownership of the Software Restitions on Copying Vitro HiCycle System User Manual HiTest Version 50 Vivier Labs its licensors own and will retain copyright trademark trade secret and other proprietary rights in and to the Software and the Documentation THE SOFTWARE AND THE DOCUMENTATION ARE PROTECTED COPYRIGHT LAWS AND OTHER INTELLECTUAL PROPERTY LAWS You obtain only such rights as are specifically provided inthis 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 D
52. mount of air bubbles The debubbling process may be shortened by attaching and filing the Pressure Head reservoir section 3 3 With the Scan Valve NOT aligned with a chamber air bubbles can be expelled by the pressure head through the chamber when the top port is opened 68 Draining Chambers 5 With the viewing window on and the pressure head stopcock closed attach an empty syringe to the bottom drain port stopcock on the chamber 3 Open the bottom drain port stopcock Open chamber to atmosphere by removing top luer ting Begin emptying the chamber using the syringe HiCycle System User Manual HiTest Version 50 5 When the syringe is full dase the bottom drain port stopcock amp Remove the syringe and empty it 7 Continue and repeat steps 1 through 6 unt chambers are empty 3 With windows removed ee section 6 1 residual can be removed using a syringe 69 Scan Valve Operation The Scan Valve is supplied with two pressure transducers installed to measure inflow and outta pressure of each valve The vertically mounted pressure transducer on the Scan Vale shouldbe used as guide tor alignment with the index mark on each chamber NOTE When pressures are not being monitored the Scan Valve should be set between chambers as shown below This wil eliminate cycling pressures from acting on the transducers extending the transducer ife en ai aie char wi tee re HiCycle Sy
53. n File prompt No Sync Pulse Detected warning display in Live Running mode Invalid Cycle Length Missed Data Packets and Variant Cycles warning messages Warning displayed i calibration file gain deviates by gt 1 mVimmHg fer gain and 15 mV tor offset User manual download link accessible through Options menu button Top Level Toolbar Backward compatible with accumulated with previous versions of HiTest The following are notable changes made in HiTest version 5 0 Calculation of the 95 and 5 rules updated to match wording in ISO 5840 2013 3 Appendix 0 7 RW no longer created All accumulated cycles are now captured in TST file CSV and TST Data Fles window removed Files are be opened through the Open File icon on the Top Level Toolbar Timostamps given to default Calibration flle names Additional information popup windows for buttons Accessing Flle longer displayed in tite bar while selecting Calibration fle BA Vitro HiCycle System User Manual Labs HiTest Version 50 11 Appendix A Valve Ring Molding and Mounting Silicone rubber rings are recommended for mounting heart valves or other test specimens The rubber rings provide a flid seal between the device being tested and the test system flanges Eme 4 i 114 Design and Fabrication Considerations Since each size and type of test device differs in geometry a unique rubber ring is required in order
54. n the Controller Ensure Amplitude is set to 0 0 Press rhe Standby button to remove from standby mode Press the Start button Slowly turn the Amplitude knob to approximately 0 8 Listen to each chamber carefully for a squeaking chafing sound If any chafing sound is audible see section 9 5 for alignment instructions HiCycle System User Manual HiTest Version 50 5 Controller Operation The following sections describe the set up and use ofthe HiCycle Controller functions Most Controller functions are managed by the Precision Digital Rate Totalzer Batch Counter Controller Rate Tetslaer The Rate Totalzer buttons perform multiple functions the relevant function for each button press has been emphasized e g in the procedure 53 Frequency Amplitude and Offset Controls AMPLITUDE OFFSET FREQUENCY The Frequency Amplitude and Offset controls all include a dial lock switch recommended that the dials be locked once the desired settings have been made to prevent the dil settings varying due to the vibration ofthe Module See section 41 The desired valve test frequency shouldbe set before increasing the Amplitude setting The Frequency dial sets the oscillating rate of the Module The range of the Frequency setting is approximately 500 bpm 8 fo 1650 bom 275 NOTE ttis not recommended to run the sytem at greater than 2080 bpm 18 Hs due to loss of accuracy of pressure rea
55. nt they can be removed as follows 120 Remove Module shroud as described in section 92 200 Remove bolt securing piston using 9 58 driver and then remove piston 320 Remave boit and washers at base of piston rod yi HiCycle System User Manual Labs HiTest Version 50 A Remove piston rod from narrow end of Bellows 5 Remave four bolts from Bellows lange at the wide end of bellows using 3 32 hex head key 6 Cipthe existing tie wrap with side cutters Ballows Flange 1 Beliows 108 Bellows Clamp 12355 Ta install bellows 120 Position clamp over wide end of bellows and secure clamp using four bolts with 3 32 hex head key to Module base plate so that bellows seals to this plate 2 Push piston rod through neck of bellows COUNTERBORED END OF ROD ONLY 3 Secure piston rod to pusher plate using bolt and washers A Ensure that the Bellows are not twisted or crooked NOTE Misalignment af bellows can cause the bellows to rub on the piston red This resuhs in premature wear on the bellows Place the two halves af the Bellows Clamp around the narrow waist af the Bellows 6 secure with anew S te wrap HiCycle System User Manual HiTest Version 50 95 Piston Alignment The piston rods and pistons must be centered in the cinders for proper operation Alignment can be checked as described in section The pistons can be aligned as follows 1 Remove the Module
56. ocumentation any copyright or other proprietary rights notice any disclaimer and you shall reproduce on all copies of the Software made in accordance with this Agreement ll such notices and disclaimers Other Restrictions on Use This Agreement is your proof of license exercise the rights granted herein and must be retained by you You may not use any portion of the Software separately rom or independently of the Software and other than far your normal business purposes You may not provide acces to use of the Software to any third party consequently you may not sell license sublicense transfer assign lease or rent lincuding via an application service provider ASP or timeshare arrangement the Software or the license granted by this Agreement You may not modify ar make works derivative of the Sofware and you may not analyze for purposes competitive to Hest reverse engineer decompile disassemble ar otherwise attempt to discover the source code of the Software except in accordance with the following f applicable as it contains trade secrets of Labs and licensors 182 The license granted herein will continue unt it is terminated in accordance with this term ViVtr Labs terminate the license granted herein immediately upon written notice to you justified cause including without limitation breach ot any provision of this Agreement or if you breach any provision of this Agreement and
57. ocumentation 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 e move the Software from the country in which you first licensed it without the appropriate United States foreign government licenses and the writen approval of Labs and its licensors The United Nations Convention on Contract far the Intemational Sale of Goods 1980 s here by excluded in its entirety from application to this License Agreement The English language 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 permisible and the remainder of this Agreement Sha remain in ful force and effect HiCycle System User Manual Labs HiTest Version 50 ir you purchased this product in Canada you agree to the following The partes hereto confirm that it is their wish that this Agreement as well as ther 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 s y rattache olent r dig s en
58. oloured heat shrink from the connector junctions near the end of transducer cables as shown below 2 Unplug the pressure transducers from the cable and save the transducer as a spare sedis BTA Wi a 519 HiCycle System User Manual HiTest Version 50 Plugthe cables into the Scan Valve pressure transducer cables Ensure the cables are logged into the correct cable based on their colour coding blue inflow lower transducer red to cuttlowfupper transducer 4 Connect the remainder of the Data Acquisition as shown in he schematic on the allowing page See the Data Acquisition System User Manual for further information Nitro HiCycle System User Manual 1 HiTest Version 50 sedis BTA Wir La III HiCycle System User Manual HiTest Version 50 System Setup This section provides the user wth Controller Setup Before switching the Controller power on Ensure all system cable connections have been made See section 33 for deta Set the Amplitude contro to 00 Ifthe dial will not tur ensure the dial lock lever shown below is switched up for the unlock position CAUTION if the amplitude is not at O when the system starts damage may occur at high amplitudes Set offset control to about 5 0 Dial Lock Set Frequency control t outs Set the Temperature Controller to OF
59. on 50 Cap Salty Cap Micro capilary Cap NOTE The pressure transducers in the Scan Valve should only be capped with the Safety Caps provided The Safety Cap includes a micro channel and an entrapped air volume to suppress low frequency pressure transients without compromising high frequency pressure fidelity of the transducer system To be effective the Safety should contain an entrapped air volume and can be primed as follows 1 Position the Scan Valve to be aligned with a chamber that is open to atmosphere 2 Remove the transducers Safety 3 Remove the non vented cap from the Safety Cap Attach an air filed syringe to the Safety Cap connector if necessary remove fuid from catheter iine using the syringe 5 Placethe miero capillary cap in a container of distilled water 6 Use the syringe to draw fuid through micro apiliary cap until catheter line is half ied with uid f the micro capillary is blacked the Safety Cap not functioning properly and should be discarded and replaced with a new assembly 7 Remove the syringe and secure the nan vented cap to entrap theair volume 3 place the Safety Cap on the transducer The Safety Cap on the lower Scan Valve pressure transducer can be removed as follows 1 Align the Sean Valve so that the lower Safety Cap is visible in between chamber 2 Insert a flat blade screwdriver in between the chambers 3 place the blade of t
60. owered dispenser and barrel reservoir piston combination however considerable force necessa to inject the rubber mixture The tapered tip e g 11617 8 should be attached to the syringe before dispensing the rubber 113 00 1100 Silicone Rubber Properties This rubber is made by Silicone P O Box 363 211 Woodbine Street High Point NC 27260 USA Ph 336 886 5018 Fax 336 886 7122 btep www siconesine com It has extremely high tear strength and is a highly elastic two component tin catalyzed RTV Room Temperature Vulcanizing icone rubber yi Vitro HiCycle System User Manual Labs HiTest Version 50 314 Mounting Ring Mold Assembly The Insert E Dark GREY should be removed when making rubber rings for use in the Hicyte system With the middie ring YELLOW over the base PURPLE attach the Custom Pedestal or device replica light GREY so that iis centered and square to the base rc PURPLE The method of attachment wil depend on the device Fil the assembly with silicone rubber GI 1100 recommended which has been de erated as described above Prior to complete jig assembly and filing with rubber it is recommended that rubber fist be applied deep undercut regions using the barrel reservair and tapered 8 This avoids entrapping alr in those regions where the fou ofthe viscous rubber can be problematic Pace the upper ring GREEN over the midde ring YELLOW and lock with thumbscrew C Adju
61. ownload Reposition this icon and dragging wil reposition the Hest session window toolbar Minimize Minimize the software window to the Windows et loses the application NOTE Most controls on the user interface have tooltips that give brief explanation of usage whenever the mouse is hovered over the control NOTE fles saved from the software are saved to the Files folder of the software directory e z ChProgram Files ViVitro Labe Testes Vitro HiCycle System User Manual Labs HiTest Version 50 73 Support Information The Support Information Area hosts key information regarding valve and trial eadings resuts for your NOTE This area depicts the information for the selected valve according to the Valve Controls on the fight ofthe screen Collapses the selected data area Opens the selected data area Session Information Operators are expected to complete each field to ensure that each trial and valve can be individually characterized Most fields are editable however the Target Pressure value is taken from the Target Differential Pressure toggle button for the selected valve chamber im the TRANSVALVE STATISTICS are at the bottom of the sereen Trial date automatically loads the current date and time When accumulation is started While creating data for each valve note that the Information remains the same in each field The operator is to manually change the Valve
62. ple counts outside 10 of average 0 W either the missed scan packets during accumulation or cycles with sample counts outside 10 average greater than O the data should be discarded Ifthe number of cyces with sample counts outside 10 average is greater than O increase the Sampling Rate during Ive running mode in the A D Acquistion Control area cick Synchronize HiCycle and accumulate data again TST Files fles are created by HiTest during accumulation and contain the raw data used by Saving Opening and Printing a TST Fle ES MEME The tst fle contains data for the number of cycles in view A save window wil be displayed and enable the user to customize the filename Atemately the user can opt to use the automatically assigned fle created from valve identifier information date and time NOTE the session wil remain static until otherwise instructed therefore enabling the operator to carry out data analysis as required Vitro HiCycle System User Manual L abs HiTest Version 50 len cia ope Peli LIE e NOTE This action wil enable the operator to carry out print snapshot and excel export activities pertaining to the data saved 3o Torento tele Amin ente tre nb 4 Toview the te fle in text form open desired st fle from is fle location in a text editing program such as notepad mmddyy teta us
63. r the window and secure using 3 32 driver NOTE Adjusting the window retention clamps after tuning the system will akter the operating pressures in the chamber Ensure clamps are secure priar to tuning HiCycle System User Manual HiTest Version 50 63 Mounting Test Samples In order for the loading on the Module to be balanced either 2 3 4 ar chambers shouid be used in the configurations shown below Other configurations may be used but depend on t It is recommended that the same valve type and size of sample be used in each test chamber It may however be possible to achieve target test conditions with samples af one nominal size difference Two sampes Should be Tiree samples should Faursamplesshouldbe samples loaded placedso thattheyare placedinakernate placed opposite each n diametrically chambers other opposite chambers To maunt a sample follow these steps 1 Remove chamber window see section 11 1 Unscrew the two bolts securing the piston cap using a 5 64 x ey Remove the piston cap 8 Fit sample into a molded silicon rubber ring specifically tailored to the sample s geometry NOTE provided for molding valve mounting rings These rings are common to all ViVitro Labs equipment See Section 11 for a description of mold fabrication Samples are usualy mounted with their outflow side facing up to allow visualization of the outflow through the
64. radually increase Amplitude to the previous setting Recheck pressures The Offset pane control setting has some efect on the Frequency setting The Frequency should be checked after adjusting Offset and re adjusted if required 52 Operating Modes Rate Relay 1 Frequency Flag MenulAdvance Stai BatehvF2 Cyclo Total CAUTION Keep hands and face away from the Module when starting Ait C HiCycle System User Manual HiTest Version 50 The Module can be Started Paused Resumed or Stopped as described below 1 Start Ensure the Amplitude dial is set to 0 0 Press Stat gt F to begin operating The Relay 1 Alarm fiag is displayed f the red LED on the controler Standby button is iluminated press the Standby button to ext Standby mode Slowly increase the Amplitude dial ta begin Module operation 2 Pause Resume Press once Pause operation PAUSE will be displayed on the panel Press to resume operation Operation may also be paused by pressing the Standby controller button ses below The red LED on the Standby button wil be iluminated when in Standby or Pause mode stop Press Sent a second time to Stap operation StoP willbe displayed on the panel The red LED on the Standby switch will be illuminated when in Stop mode Press to resume operation While the Module is in running operation will continue uti the preset batch counts re
65. re reports can be created to demonstrate or record this data BA Vit TO HiCycle System User Manual 205 fest Version 80 yi Vitro HiCycle System User Manual HiTest Version 50 8 10 Taking a Snapshot Snapshots enable the user to display represented graphs ofthe trias valve cycle activity waveforms at any moment during the durability testing 5 The Process Display area can be manipulated to zoom in or out using the zoom buttons The focus and extent of data can be manipulated via the Cycles in View buttons in the top right comer of the sereen A minimum of 3 and maximum of 8 cycles can be displayed The vertical shift of the graph can be adjusted using the arrow buttons in the lower left comer of the window NOTE To capture the full Hiest sereen press SHIFT and click HiCycle System User Manual HiTest Version 50 Saving Opening and Printing a Snapshot 4 selecting the Snapshot button will capture the Process Display area as itis seen onthe Screen A save window will display to enable the user to customize the fle name ltemately the user can opt to use the automatically assigned name created from Vaive identifier information data and time NOTE The Snapshot will not apen immediately but be saved to the Files directory of the software later viewing Loo Access the fle via Explorer under Clrogram Flesl Viro Labs West ils NOTE file will be identified wi
66. rs and re adjust restrictors for target pressure opening is insufficient increase amplitude stan chambers re adjust restrictors for target pressure Vitro HiCycle System User Manual HiTest Version 50 85 Accumulation Procedure Before data accumulation operators must adjust the Controller unt the test parameters satisfy he intended test criteria The system must also be tuned as described in section 8 5 and calibrated as described in section 83 prior to data accumulation Periodically over the of the trial users will need accumulate cycle measurements e g every 10 000 000 cycles This process would be carried out for each valve mounted in the Hiycle Module A running average is kept of 3 critical values during the Accumulation Process Peak Differential Pressure mean and standard deviation Percent of each cycle that meets or exceeds the target differential pressure mean and standard deviation 5 rule Porcent af cycles exceeding the 5 rule 95 rule The document ISO 5840 32013 in Annex O7 i Report requirements states that a durability assessment report should include verification that targeted pressures across the closed valve were attained for at Jeast of each cycle during atleast 95 of the test cycles NOTE System must be calibrated and tuned to meet the test rera live running mode prior to data cumulation NOTE Prior to accumulating large amounts of data ensure th
67. rs with fluid through the open window ports ensure that all ports on each chamber are closed or capped When the windows are in place filing with fluid can be completed and air removed from the chambers as follows 1 Remave all chamber windows see section 6 HiCycle System User Manual Version 50 Fil each chamber with fuid ensuring that no leaks occur before continuing to the next chamber Fil to approximately half way up the top chamber plate i Using a non abrasive instrument dislodge any visible air bubbles from the chambers Remove the top fitting caps Replace the chamber windows and fasten in place see section 6 2 Attach a syringe filed with test fluid to the bottom drain on the chamber Open the stopcock and begin filing the chamber 7 Continue filing until a small amount of water comes out ofthe open tap fitting itro HiCycle System User Manual Labs HiTest Version 50 3 Close the stopcock and remove the syringe D Replace the on the top luer fitting 10 Repeat steps 6 through 8 until al required chambers are filed 11 Continue to section 67 to debubble chambers 66 Pressure Head Assembly Operation The Module should be operated under postive head of pressure The Pressure Head Assembly provided with the system provides up to 65 mmHg of positive pressure head The postive pressure in the system assists in sealing Scan Valve and
68. rsion 50 5 stage Hest displays the Pressure Calibration Values table on the right hand side of the screen This table displays the saved values entered during the process derived from the tairation fle The Calibration Wizard wil now begin Complete the Wizard entries through the 5 steps of Pressure Calibration to edit or calculate outflow and inflow sensor gains and the 3 steps of Sensor Static Head Zeroing to edit or measure the zera offsets for these sensors When using the Labs Data Acquisition System the following procedure is suggested for adjustment of the amplifiers and calibration of both pressure transducers simultaneously 1 of 5 Pressure Calibration will prompt the user to either accept current calibration Vales or to proceed with calibration Calibration values may also be manually entered and saved by clicking Accept Vitro HiCycle System User Manual Labs Hes Version 50 2 Onstep 2of5 the program prompts for values of lower and upper calibration pressures They shouldbe chosen to span the expected working range of the transducers e g 0 200 mmHg a requires the user to drain the system to capture the lower pressure reading specified in Step 2015 Refer to section 6 for instructions on draining the chambers When recording the average lower pressure voltage ensure the lid is removed from the chamber ora stopcock on the chamber s open to atmosphere if O mmHg w
69. s HiTest Version 50 32 Unpacking 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 Vitro Labs CAUTION INIURY CAN OCCUR FROM IMPROPER LIFTING OF HEAVY LOADS DO NOT MOVE MODULE BY HANDLING VALVE TEST CHAMBERS The Module weight is 25 kg 55 Ib It should be unpacked as follows 120 Lift the inner shipping crate out of the box using the handie on the and place on fim surface 2 Remove 4x philips head screws from the two sides with the Unscrew here first labels 3 Liftoff the top of the crate box off of the base using the handle on top of the crate sedis BTA Page Ta yi HiCycle System User Manual HiTest Version 50 A Remove shipping bots under the crate base releasing the Module Liftthe Module to the mounting location optional cart ar secure bench DO NOT LIFT BY THE MODULE CHAMBERS Lift the HiCycie by the bottom plate of the Module 6 Remove three black shipping spacers beside the rubber Module base piate isolation mounts store with the shipping crate for future shipping 7 Remove packing materials fram the Module 8 Unpack Controller power cable and connection cable Inspect the Module and Controller for external signs of damage in shipment The alignment
70. s frst Pulse Duplicator the Vitro name has been synonymous with cardiovascular device testing equipment Nitra hardware and software products have been used by leading R amp D facilities and academic labs worldwide and its equipment and testing methods have been cited in hundreds af peer reviewed publications http ViVitrotabs com company cited publications The Labs Pulse Duplicator System in particular the ViVre Labs SuperPump has become a worldwide standard to simulate physiolagical hear conditions in academie research applications Labs nc holds ISO IEC 17025 accreditation for laboratory testing services endorsed by and based on ISO 5840 This scope of accreditation includes the physical and mechanical testing of heart vale substitutes including durability hydrodynamic and visualization testing ivitr Labs is widely recognized as the authority on cardiovascular device testing Vitro 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 aver 30 years and is renowned for its proven success from product development testing through to full regulatory submission Labs is a member af the 5840 standards committee and is actively engaged in developing regulatory requirements Leveraging this intimate knowledge of the standard Labs ensures that te
71. s in view to allow for appropriate level of cycle detail Fush transducers with syringe to remove any air bubbles The pressure tracings should have a relatively smooth trace with minimal high frequency noise Follow Data Collection section 15 1 but capture found state and save data files HiCycle System User Manual Labs HiTest Version 50 are meeting the criteria specified in the test plan and ISO 5840 record these valves valves are not meeting the criteria contact study director before proceeding 6 adjustments are required o bring he system back in ine with parameters listed in the test plan fallow section 0 record the Tune State following section 15 1 7 Once the system is tuned to the desired conditions capture high speed video 8 Oncetestingis complete have study director sign off 1514 Functional Evaluation At intervals specified in the test plan the valves will be removed from the Hiycle and inspected dor wear At this paint additional hydrodynamic assessments may be made Before removing valves capture found state and found state high speed videos Check that temperature on controller is accurate using a calibrated thermometer 2 Remove valves Conduct assessment as outlined in 154 5 After the study director has reviewed the data and videos in accordance with the test plan for acceptance criteria including signs af wear or functional impairment reinstall devices
72. s that this be done frequently within session particularly before starting new valve data accumulation Follow the Calibration Wizard to complete steps 1 through 3 1 step 1of3 af the Sensor Static Head Zeroing will prompt the user to either accept current talibration values or to proceed with calibration BA Vitro HiCycle System User Manual Labs HiTest Version 50 2 step 2of3 requires the user to fil the system See section 65 for instructions on filing the system Step3 of displays the newly calculated static head calibration values in Volts The user can Click Finish to accept the values or click Repeat to calibrate again if Finish is clicked the users ven the option of saving the calibration fg as a new name HiCycle System User Manual Labs HiTest Version 50 Once the Calibration Process is completed the Pressure Sensor Table displays the values within the Support information Area on the right hand side of the screen NOTE calibration values begin deviating from their historical ranges the pressure transducers should be replaced During calibration a warning will be displayed if the gains deviate by gt 1 mV mmHg and offsets deviate by gt 15 m from previous calibration values See section 96 instructions fon pressure transducer replacement Contact ViVitro Labs to obtain replacement parts Pressure Transducer part number 06146 NOTE Risk analysis req
73. ss of profit 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 retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording scanning otherwise without the prior written permission of the Publisher Requests to the Publisher for permission should be addressed Labs ine 455 Boleskine Rd Victoria BC Canada 2167 warn ViVinrolabs com infegViVtrolabs com tel 2503883531 free 877 588 3531 fax 2504831975 BA Nitro HiCycle System User Manual Labs HiTest Version 50 Table of Contents 1 AboutViVitro Labs 14 About This Manual 1 2 Abou AR Series System Hardware 2 Cautions 3 System Assembly 3 Ust of Components 12 32 Unpacking 13 33 Hardware Assembly 14 System Setup 43 Controller Setup 22 42 Heater Setup 23 Piston Alignment Check 25 Controller Operation Frequency Amplitude and Offset Controls 26 Operating Modes 27 Default Rate Tolalzer Display 29 Alternate Rate Totalizer Displays 7 Batch Counter Preset a Counter Reset Functions E Module Operatio 61 Chamber Window Removal a 62 Chamber Window Insertion aa 53 Mounting Test Samples as Requirements as 65 Filing Chambers as 65 Pressure Head Assembly Operation 67 Debubblng Chambers 29
74. ssure transducers This consists of a two point pressure calibration and static head compensation Use a manometer for pressure reference to ensure that calibration is valid L start HiTest software and open the calibration file that the software defaults to eum 3 completion of calibration the inflow outflow and transvalve diferential pressure should ali read zero when the pressure transducers are open to the test fuid BA Vitro HiCycle System User Manual Version 50 Save calibration file 158 Baseline Assessment W required by the test plan conduct an initial inspection af the valves required by the test lan conduct an initial hydrodynamic assessment Perform high speed videography to record the opening and closing characteristics of the in the pulse duplicator After the completion ensure data is backed up 159 Setup and Loading Reter to section 4 for detailed instructions a n Set cycling frequency in accordance to test plan Reset cycle count on tester if required Fil with enough test fluid to cover the samples but not cause overflow while installing samples Turn on heater Set temperature set point according to test plan Using calibrated thermometer ensure displayed controller temperature accurate Install samples and install ids as per test plan and or sections 62 and 6 3 Record location of valves in the lab notebook I less than valves are being tested
75. st protocols wili meet the ever changing regulatory requirements ViVitro s Laboratory Testing Services offers an ISO IEC 17025 certified ab using Vitro equipment to conduct 3rd party independent testing Viros accredited testing lab is governed by a mature Quality Management System QMS certified to meet the 5840 This gives assurance ta 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 About This Manual This document describes the HiCycle AR System s procedures for Assembly of the systers hardware System setup Operator procedures forthe system s daily use Test software operating instructions For further information on the optional Data Acquisition System please see the Data Acquisition System user manual A Nitro HiCycle System User Manual HiTest Version 50 12 HiCycle AR Series System Hardware The Hicycle System assesses the durability of prosthetic heart valves and other cardiovascular products biomaterial specimens This assessment can be used to determine the valve s continued function over a reasonable lifetime The HiCyce System provides accelerated life cycle testing of up to 6 heart valves biomaterial specimens at a time This is laboratory test instrument not designed for use on humans or animats The HiCycle System us
76. st the locked assembly GREEN YELLOW on the base PURPLE so that when rubber fils the cavity the level of rubber is even with the op edge of the upper ring GREEN and about 23 mm of rubber covers the top ridge of the pedestal device TAN This top covering layer of rubber should be suficent to secure the test device during forward flow conditions 115 Mixing RTV Silicone Rubber For making one rubber ring about 15 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 2 large hole in the syringe end The base is to be mixed with activator at a 10 1 ratio 116 De Aerating and Dispensing Mixture Immediately after mixing de aeration of the mixed rubber to remave entrapped aris recommended Removing air bubbles helps ensure the rubber rings sealing ablity and provides uniformly dense rings Proceed a follows Place the mixing cup with the mined scone rubber into a small volume vacuum chamber e g part VCS991 365 chamber volume Attach a hand operated vacuum pump to the vacuum chamber using X inch LD hose eg P 79301 20 Evacuate to about 24 ing 610 mmHg vacuum The mixture will expand towards the 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 c
77. stem User Manual HiTest Version 50 Sear Ve ane menor rasa The tension between upper and lower Scan Valve elements has been set at ViVitro Labs to give minimum friction while stil sealing The three knurled white tension adjustment knobs on top of the Scan Valve have been factory set Normally adjustment of the tension should be necessary ef possible that as the unit is warming from room temperature to the set point temperature and before Pressure Head is applied to the unit there may be some initial seepage of test fluid from the upper or lower Scan Valve elements This can be removed with an absorbent cloth fit occurs seepage should cease when the Scan Valve elements are pressurized and the temperature is stable The Scan Valve should be turned using both hands the handle If the Scan Valve s difficult to turn friction may be reduced by turning each the three knurled white thumb nuts on the top of Scan Valve ants ockwise few degrees If the Scan Valve assembly seems locked it may be due to mis seating of the tapers in the upper and or lower Scan Valve elements of the assembly They may be unlocked and as folus 1 Tum each ofthe three white knurled adjustment knobs anti clockwise approximately 30 2 Push down simultaneously on the ends of the three 3 threaded draw rods to unlock lower element of Scan Valve 30 Place fingers underneath upper element and pull upwards to
78. t the same time a control device may be cycled in order to compare the performance of the test valves to that of similar valve that is currently available in the market and tatis clinically approved Performance wil e evaluated through hydrodynamic and visual inspections performed throughout the test Vitro HiCycle System User Manual Labs HiTest Version 50 sedis ESTA ELI 519 HiCycle System User Manual Labs HiTest Version 50 184 Equipment Required Calibrated Ensure equipment has a valid calibration before using 5 Manometer Thermometer other Miro Labs Hicycle Strchoscope Data Acquisition System including Test Highspeed video recording system Test fluid Syringe Laboratory notebook for submission testing a dedicated notebook is required Pash ight Hex Keys 155 CAUTIONS Always perform amplitude and restrictor adjustments slowly Where possible ensure valves are connected to pressure transducers and showing lve readings in HTest to ensure valves are not experiencing undue stress Use cation to avoid spiling test fluids as electronics reside below the module 156 System Setup 1 Set up the durability tester as per section 4 2 Turon durability tester controller and AmPack to allow electronics to come up to operating temperature 3 tum on the heater to allow it to come up to required temperature 157 Calibration Calibration is only required for the pre
79. ted data will then appear within the proces display Selecting the Accumulating button while the accumulation isin process will abort the activity Gac ae To resume the lve data view when viewing accumulated data select this button 7 6 Results Panel The results panel hosts running statistics regarding pressure loads and A D Acquisition It allows operators to adjust the way live pressure data acquired HiCycle System User Manual HiTest Version 50 Transvalve Statisties MERE uiua tho Target Pressure Boundary here to osha oye REN affect the Session Information data Live mean diferential pressure statisties tracking valve performance during extended testing are played Asa trial is running the rules wil display as each cycle complete The Peak Differential Pressure is displayed in this panel NOTE The target transvalve pressure threshold is signed negative to indicate it is the pressure across the closed valve This target pressure load threshold sets the criterion by which two important result needed for 5840 2013 compliance are calculate 95 ond 5 Rule Percent af cycle reaching or exceeding the target pressure 5 rule Percent of cycles that exceed the target pressure threshold for gt 5 of the cycle 95 ISO 5840 2013 Appendix 0 7 states that verification that targeted pressure across the closed valve were attained for at least 5 of each cycle during at l
80. tem User Manual HiTest Version 50 1 insert the nipple ofthe Pressure Transducer HCMO18 into the Lower Scan Valve 2 Install he Retainer Pate HCMO14 to the Pressure Transducer Standoffs HCMOL with the 2 56 x3 8 Modified SHCS HCMO15 Use calibrated driver to install at 2 in ibe 3 T hten the Female Luer end ofthe Safety Cap Assembly HCMO23 onto Male Luer fiting on top of the Pressure Transducer standard transducer typically for use with other Vitro products needs to be modified to be compatible with a Scan Valve fallow the steps below 120 Break the collar from the nipple of the Pressure Transducer HCMOLB See image to the left below 220 Cutthe end ofthe Pressure Transducer so that the nipple is 10mm long See image to the right below push an Oring HCMO17 on each of the nipple of the Pressure Transducer fl TO 10MM 7 Vitro HiCycle System User Manual Labs HiTest Version 50 10 HiTest 5 0 Release Notes The following features aro now in HiTest version 5 0 Standardized output format and trial information display CALIBRATING LIVE RUNNING and REVIEWING mode display in Top Level Toolbar Number of accumulated cycles displayed in REVIEWING mode File name and date of active calibration displayed on Process Display Most recently accessed calibration flle recalled during Selecta Calibratio
81. th 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 Openthe desired Snapshot NOTE This wil open the computers preferred jpg fle viewing program 4 select to print fromthe meno 8 11 Exporting CSV File Data For researchers developers wishing to extract the data to create algorithms and cacustions to provide specifie results the option of producing a raw data csv file is available The output fle contains cycles By clicking on esv after accumulating data during the durability testing HiCycle System User Manual Labs Hes Version 50 The output is suitable to be viewed and manipulated within a spreadsheet program Data supplied includes trial valve and Hicycle Unit information as well as data created during the current cycle testing and raw infiow Ourtlow pressure measurements throughout the displayed cycles Saving Opening and Printing CSV File Data 2 Access the le Explorer under C Program _Fls ViVitre_Labs HiTest Files NOTE The wil be identified with csv format The name wil be the identifier information entered for the valve and the date and time or the customized name the operator assigned Openthe desired co NOTE This will open within the computers preferred co viewing program 4 Select to print from the menu Vitro HiCycle System User
82. throughput video card VO Module 22068 Hard drive Quad core processor 666 or better Software Requirements For the software run smoothly the following software required to be installed computer Microsoft Windows 7 Profesional 3S framework 7 Software Interface Orientation Below is the home screen of 72 Top Level Toolbar Am Standard controls in the top evel toolbar are LH New Trial Resets in preparation new valve trial Open File Brings up a standard open fle dialog window to low users to select a valve test fle for review HiCycle System User Manual HiTest Version 50 Save File snapshot Print save esv File Append Saves a valve test tst fle for the currently selected valve in focus statisties means and ts latest raw pressure buffer ling the Save button saves the status of the latest acquisition to a test txt This allows users to record a data snapshot of the vave s behavior for later review Typically users daing extended testing of a valve will periodically daily even week accumulate several cycles and then save a test file for the latest accumulation to record the valve state at that time Captures a screen snapshot jpg fie of the acquisition graph To capture the full HiTest window hold the shift key down while clicking the Creates a report html file of current conditions and mean resul
83. trade usage and specifically the warranties of merchantability and finess for a particular purpose In event may you bring any claim action or proceeding arising out of the warranty set forth in 18 4 more han one year after the date on which the breach of warranty occurred Limitations on xcept as required under local taw the liability of Labs and its licensors whether in contract tort negligence or otherwise arising out of or in connection with the Software Documentation furnished hereunder and any service supplied from time to time shall not exceed the license fee you paid for the Software or any fee you paid for the service In no event shall Labs or its censors be Tabie special indirect incidental punitive or consequential damages including without limitation damages resulting from loss of use loss of data loss of profits los of goodwill loss of business BA Vitro HiCycle System User Manual HiTest Version 50 arising out of or in connection with the use af or inability to use the Software or Documentation furnished hereunder and any service supplied from time to time even if Vitro Labs ts licensors have been advised of the possibilty of such damages Notwithstanding the foregoing in no event shall Labs liability be limited in the case of death or personal injury arising ss a result of the negligence or wilful misconduct of Vitro Labs 185
84. ts for the curently selected valve being tested Saves most recent valve test statistics means and pressure data to CSV comma separated value csv file type text file for ready access Averages and A D voltage data for a single A D period are saved a current state entry to the Iog fle for the current test The log file name i buit from the trial date Live acquisition is interrupted only briefly and the user is notified writing to the log fails due to an A hidden log is kept for every Hicyle session as a means of auditing events and user actions for regulatory and troubleshooting purposes This is HiCycle System User Manual Labs HiTest Version 50 a background process and there is no indication at the time these entries are made This log name is simply a time and date stamp eg 20 17 09 15 00008 These log fles are kept in the C Program Files ViVitro_Labs HiTest Fles Logs folder and should be archived or cleared out periodically when they are longer likely to be referenced Calibrate Interrupts Live Running mode and starts the calibration sequence Users can manually edit re measure pressure sensor gains and zero offsets to update the calibration fle cfg fil for the connected HiCyele Unit Ali Menu Access to all features and information about HiTest including Graph syne signal Open Excel on csv save option Loading calibration les User manual d
85. ts opening In this case the spring configuration should be changed to PUSH as depicted by Removing nut using 3 8 driver 2 Removing spring collar spring amp spring washer Inserting new spring spacer spring collar and spring adjuster Nit HiCycle System User Manual 7 Hes Version 50 13 Appendix C Alternate Pressure Head Configuration Some users may wish to use connect the Pressure Head assembly and the pressure transducers directly to the external fitings of the HCyce for collecting data This configuration easily be assembled using standard tubing and fittings externally connect the Pressure Head assembly and allow for externally mounted pressure transducers set up the HiCycle module as shown below HiCycle System User Manual HiTest Version 50 NiVitro HiCycle System User Manual HiTest Version 50 14 Appendix D Recommended Spare Parts Kit The recommended spare parts for the HiCyde system are listed below tis recommended that the parts lated be kept an hand to reduce down time in the event of a component Contact Labs to purchase a Spare Parts Kit Description Part Number unity CHAMBER WINDOW BOW 5 H jce Pressure Trsnsducer Remy 06146 TOP TEFLON SEAL AN B CUP TEFLON SEL 3286 WOW T TEFION O RING MOD ROOST B ORINGY 36 70 BONOS 5 RING EO EELA 16 1 225 77 OMS 5 DANG 070 WOW
86. uires that this calibration fle be protected by a checksum and should the fle be accidentaly corrupted users are notified and given the opportunity to stop the program and cover the original calibration fle from the distribution medium BA Vitr HiCycle System User Manual Labs HiTest Version 50 85 Module Tuning Since all test samples are driven simultaneously in a HiCycle changing the load on one valve may affect other valves Therefore system adjustment is an iterative process followed until the desired operation ofall valves achieved ond the system is tuned NOTE For best tuning it is advised to operate the system with valves ofthe same size and type in each chamber i may be possible to run with dissimilar samples This can only be determined by experiment NOTE Adjusting the window retention clamps after tuning the system will alter the operating pressures inthe chamber Ensure clamps are secure prior to tuning The following sequence for tuning is suggested 1 Set all Module restrictors to 50 installed valves are al the same size otherwise set lower restrictor values for small sizes and higher restrictor values for large sizes Monitor a chamber and increase drive amplitude until transvalve pressure reaches target Scan remaining chambers with Scan Vale and adjust restrictors to achieve target pressures Monitor valve opening with stroboscope If opening is excessive reduce amplitude scan chambe
87. wo red thumb screws 5 Unravel the overflow drain tube at the base of the Module and position itto drain fluid from the Sean Valve away from the Module and Controller Connect the 25 pin cable to the Controller and the Module Secure by tightening the two screws on each connector with small fat blade screwdriver not over tighten HiCycle System User Manual HiTest Version 50 8 Instali sit 6 stopcocks from the Accesories Kit on the lower luer fittings of the Module ve 9 Threod the two Pressure Head Assembly rods together 10 Add a stopcock from the Accessories Kit to the Pressure Head Assembly syringe Cap the open port of the stopcock with a cap from the Accessories Ki HiCycle System User Manual HiTost Version 50 IL insert the Pressure Head Assembly in the opening in the rear left ofthe Cart optional Secure using the small thumb nut 3L Connect the catheter line to the bottom stopcock of one ofthe test chambers 33 Connect the Controller to the power supply using the cable provided If connecting a Data Acquisition System optional connect as described below alternate configuration which mounts the transducers to the outside of the Module is shown in section 13 HiCycle System User Manual Labs HiTest Version 50 120 To connect the pressure transducers of the Data Acquisition System optional to the Sean Valve cut the c
88. y ta any updates or upgrades to the Software that you may receive from time to time under a subscription service or ether support arrangement You may not load or use the Software In any computer or it without a license from Vivero 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 installing and using the Software wil signify your agreement to be bound by these terme and conditions If you do 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 isa license agreement and not an agreement for sale E 4 Grantof License Vitro Lobs 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 fe 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 in use on a computer when it is loaded into the temporary memory Le If the potential number of users of the Software exceeds the nu

HC-002 HiCycle User Manual

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