PD-002 Pulse Duplicator User Manual
Contents
1. or otherwise arising out of or in connection with the Software or Documentation furnished hereunder and any service supplied from time to time shall not exceed the license fee you paid for the Software or any fee you paid for the service In no event shall ViVitro Labs or its licensors be liable for special indirect incidental punitive or conseguential damages including without limitation damages resulting from loss of use loss of data loss of profits loss of goodwill or loss of business arising out of or in connection with the use of or inability to use the Software or Documentation furnished hereunder and any service supplied from time to time even if ViVitro Labs or its licensors have been advised of the possibility of such damages Notwithstanding the foregoing in no event shall ViVitro Labs liability be limited in the case of death or personal injury arising as a result of the negligence or willful misconduct of ViVitro Labs 7 European Software Directive If the provisions of the Council of European Communities Directive of May 14 1991 on the Legal Protection of Computer Programs as implemented in applicable national legislation the Software Directive apply to your use of the Software and you wish to obtain the information necessary to achieve interoperability of an independently created computer program with the Software as permitted under the Software Directive Interoperability Information you must notify ViVitro Labs in wri2. described above CALIBRATION A voltage A pressure a 0 06 V mmHg for Pulse Duplicator b 0 04 V mmHg for HiCycle RWT The GAIN and SHIFT settings may need to be changed depending on the range of pressure generated in the specific application Different settings may be needed for monitoring the ViVitro Labs Inc pulse duplicator and the Hi Cycle tester Changing GAIN will also change the Output at atmospheric pressure It may be necessary to re adjust SHIFT until the required outputs are obtained at the two calibration pressures The factory preset values shown above are based on the following 1 Application Hydrodynamic Testing probable pressure range 50 to 250 mmHg 2 Application Durability Testing probable pressure range 200 to 200 mmHg Document No 20157 A ViVitro Labs Inc 2014 Page 18 of 25 V V Data Acguisition System User Manual Appendix II I O Module Re Initialization After Reconnecting In cases where the l O Module is reconnected and needs re initialization the following sequence is recommended Remove the I O Module USB cable from the PC Wait 10 seconds and then re insert the USB cable to the PC Navigate to InstaCal icon on your desktop and double click Highlight the board number in the detection box and click OK Right click on the board number in the InstaCal box and select configure E A o Confirm settings are set to a 8 differential channels Factory calibration XAPCR Edge Rising XAPCR Pi
3. recording of erroneous data the full scale capability of recording instruments should be matched to the range of the dynamic signals to be measured If your testing application involves pressures outside of the above limits the AmPack calibration should be adjusted to suit The system should be checked periodically to ensure no drift has occurred e When the transducers are exposed to atmosphere check that outputs read zero e When the transducers are exposed to a known pressure verify with a calibrated manometer outputs should be within an acceptable tolerance Document No 20157 A ViVitro Labs Inc 2014 Page 14 of 25 V V Data Acguisition System User Manual Periodic re calibration is suggested Tracking of calibration trends may help establish calibration frequency Appendix contains instructions for calibrating the AmPack 8 Pressure Transducers The pressure transducers supplied are disposable in clinical application For pressure measurements in a fluid the transducer should be filled with fluid and de bubbled For repeated use in vitro distilled water is recommended Excessive tightening of the Luer lock cap should be avoided Pressure transducer may be damaged by over pressure This can occur if a finger occludes the transducer pressure port during transducer flushing Rapid stopcock closure may also produce excess pressure Please contact ViVitro Labs Inc regarding use of other pressure transduc
4. the natural frequency of the transducer The system frequency response may be limited by fluid filled catheter lines In the OFF position the full amplifier bandwidth is available nominal 0 200 kHz 15 turn potentiometer each turn shifts output 2 5 volts between full scale 12 volts OUTPUT BNC connector between 12 and 12 volts The amplifier is stable with capacitive loads to 100 pF Document No 20157 A ViVitro Labs Inc 2014 Page 13 of 25 Vi Vi tro Data Acquisition System User Manual On Off Switch Power Entry Output Voltage Selection Fuse TRI PACK TF2001 T a FILTER Hi 7 P IY OUTPUT 3 VAS AM 1991 LOW BASS P ri 30 Hz vd 4 ANPUFIEF 1 a J lt L oCo AEN GROUND EARTH PUT a4 By VSI AM9991 2 pa a a o spe S oo os 3 are 3 B VSI AM9991 b ps pa AMPLIFIER A e E gt 10k E VOLTAGE 115 OF haa P 5 ES bi 3 SELE Volts MEJ VITRO SYSTEMS fy i ho On Off Indicator 7 System Calibration ViVitro Labs Inc normally pre sets the pressure calibration of the AmPack to values suitable for monitoring either heart valve hydrodynamic tests or durability tests The l O module in either case Is set for an input range of 10 to 10 V The factory system calibration values are Pulse Duplicator 50 to 250 mmHg 9 to 9 V HiCycle RWT 200 to 250 mmHg 9 to 9 V NOTE To avoid poor signal to noise ratio and
5. IL rO La DS inc Data Acquisition System User Manual Data Acquisition System Document No 20157 A ViVitro Labs Inc 2014 Page 1 of 25 V V Data Acguisition System User Manual ViVitro Labs Pulse Duplicator System Designed and Distributed by ViVitro Labs Inc BC Canada Disclaimer and Limitation of Responsibility ViVitro Labs Inc assumes no responsibility for any damage loss or claims which may result from a failure to follow the instructions contained in this manual Additionally ViVitro Labs Inc assumes no responsibility as a result of direct or derived injury data loss system malfunction which occurs at the fault of misuse alternation of the system or incorrect application of use so advised or directed by ViVitro Labs Copyright Copyright 2014 by ViVitro Labs Inc All rights reserved Published by ViVitro Labs Inc Victoria British Columbia Canada Limit of Liability Disclaimer of Warranty While the publisher and author have used their best efforts in preparing this document they make no representation or warranties with respect to the accuracy or completeness of the contents of this document and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose No warranty may be created or extended by sales representatives or written sales material The advice and strategies contained herein may not be suitable for your situation Neither the Publisher nor author shall be lia
6. No 20157 A ViVitro Labs Inc 2014 Page 16 of 25 V V Data Acguisition System User Manual 10 3 Pressure Transducer Model HCM018 Opor ne Ranes aaa ae n d ads ha A Sate 50 to 300 mmHg O genase uence scum EO TELO R O O 5 0 u volts volt mmHg 2 typically lt 1 Non linearity amp hysteresis coooooonccnnnnnnoooccnnnnnnanannnnnnnonannss 1 of reading or 1 mmHg whichever is greater TOT ING o lt 40 mmHg ZETO ASA AIS UOC st lt 0 3 mmHg C PP II nip ES Ysa O O O O Tenner ECT rst lt 1 mmHg 8 hours Natural Pro queno PRK E ROU PRO O O rato gt 200 Hz in water Pa RTC ozone eaten oa lod OE lo de ar ola Nac a tote lt 2 uA at 120 volts RMS 60 Hz A ren ere Rann rrr non MEME OS SRC S A irre eet nce Rian Tenner n 400 to 4 000 mmHg A lt 1 mm Hg at 6 volts excitation when exposed to a 3 400 K tungsten light source at 3 000 foot candles Volumetric Displacement lt 0 03 mm 100 mmHg 10 4 Environmental all devices Operating Storage Shipping Temperature 10 35 C 15 55 C 15 55 C Humidity 30 85 non condensing 5 95 non condensing 5 95 non condensing Pressure 110 80 kPa 110 80 kPa 110 80 kPa 11 Symbols Product was shown to comply with the CE applicable regulations in the European Community Attention consult the accompanying instructions for use Date of manufacture Indicates the serial number of the product On off O 4 E P Document No 20157 A ViVitro Labs Inc 2014 Page 17 of 25 V V Data Acg
7. RO E O Sr ese O O oda genes O O O O O 13 e Fon Panci OI ONS unio SPOR S as atte ss SO P O o Pee O P 13 Sy sien CAD LOIN sssrin nu dn E S 14 Pressure Transducers coreo EEA ctanecacd s 15 SO O aana a A E E EEEE EAEE 15 10 SPEECH CANONS gonan arene rudos sada ddaa tuha bv ae 16 10 1 O Module Model 0831 1 ccccccccececeeeeeeeeeeeeesseeeeeeeeeeeeeeeeeeeaaaaaaasseeeeeeeeeeeeeeseeeeaaueauaaeeeeeeeeeeeeessseseaaaagaas 16 102 AmPack Model AG 999 oep tods 16 10 3 Pressure Transducer Model HOM018 ccccccccccccssssseeeeeeeeeeeesseceeeeeeeeeaeeeeeeeeseeaageeeeeeesseaaaseeeseesssaasaeeeeness 17 10 4 Environmental all levices cccooncoccconnococononcccnnonononcnnonanononnnnonononrnnonannnnnnnnnnnnnnrnnnnnnnnnnnnaneranrarenananinnas 17 11 A 17 Appendix I AMPack Galibrat OT uuicaje e eo e iia 18 Appendix Il 1 O Module Re Initialization After Reconnecting oomoncccccnnnnnccncnncnnnoncnnncanconnnnnannnonennaannens 19 Appendix Ill End User License Agreement cccoonnccconcnccccnonccccnnnncncnnnnnonnnnancrnnnnnnrrnnnanrrennannrrnnaarerenannernnnss 20 1 IN Oy NIG nn E AEE EE A EEE E E A E E E 20 2 Ownership of the Software Restrictions on COPyiNQ occccccccccccoonccnnnncnononnnccnnnnonononnnnnnnnnnnnnonnnnnnnnononnnnnnnnns 20 3 Other Restrictions on USO ii ia 21 4 PP nn AA A E E 21 5 Responsibilty for Selection and Use of Software oncccccccocccnnccconcconccnoncnnncononnnononnnnnnnnnonnnnrnnnonnnnr
8. ble for any loss of profit or any other commercial damages including but not limited to special incidental consequential or other damages No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording scanning or otherwise without the prior written permission of the Publisher Requests to the Publisher for permission should be addressed to ViVitro Labs Inc 455 Boleskine Rd Victoria BC Canada V8Z 1E7 www vivitrolabs com info vivitrolabs com tel 250 388 3531 toll free 877 588 3531 fax 250 483 1975 Document No 20157 A ViVitro Labs Inc 2014 Page 2 of 25 V V Data Acguisition System User Manual Table of Contents 1 POU VIVITOLADS cis ete seine esate cts ESA secese A 4 2 Cautions and VV AUN Siac sss se resect ti 5 3 POUL IIS IN ANN eA secs sete cece E 6 4 About the Data Acquisition SYStCM ccccceseeseseeeseeeesseeeseeesseeeeeoeasseeeseoeeseeeseoenseeeeeooeenseesseoenas 6 4 1 System COMPONEN sce secnceeeccccaddannctatnccadendaedecneendasdeaddenretedcdandendecceebetataateaddeaschadeaendeedaesecnetntesdeaddaasstetnccndendacds 6 A A PP oo 6 5 Initial Set Up Procedures mus muuduan had kaki ariel de iii 7 5 1 Installing the Data Acquisition SySteM ooonccccnccccccoonncnnnnccnnononcnnnnonononnnnnnnnnnnonnnnnnnnnnnnrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnns 7 6 AmPack OC at ON simson alias 13 6 1 OPEN e neces
9. d party consequently you may not sell license sublicense transfer assign lease or rent including via an application service provider ASP or timeshare arrangement the Software or the license granted by this Agreement You may not modify or make works derivative of the Software and you may not analyze for purposes competitive to ViViTest reverse engineer decompile disassemble or otherwise attempt to discover the source code of the Software except in accordance with the following if applicable as it contains trade secrets of ViVitro Labs and its licensors 4 Term The license granted herein will continue until it is terminated in accordance with this term ViVitro Labs may terminate the license granted herein immediately upon written notice to you i for justified cause including without limitation breach of any provision of this Agreement or ii if you breach any provision of this Agreement and fail to cure such breach within fifteen 15 days of notice thereof Upon the termination of the license you will promptly return to ViVitro Labs or destroy all copies of the Software and Documentation covered by the license as instructed by ViVitro Labs 5 Responsibilty for Selection and Use of Software You are responsible for the supervision management and control of the use of the Software and output of the Software including but not limited to 1 selection of the Software to achieve your intended results 2 determining the appro
10. e e Analog to digital conversion to collect all signals into a single USB input to the e Available software makes the Data Acquisition System adaptable to any ViVitro test equipment Document No 20157 A ViVitro Labs Inc 2014 Page 6 of 25 V V Data Acguisition System User Manual 5 Initial Set Up Procedures There are seveal steps reguired in order to complete the installation and configuration of the electrical components of the DAS It is important that these are followed in order to assure successful operation and functionality Unpacking list of components The Data Acquisition System arrives in a single container Inspect the shipping container for external damage Retain the shipping carton and packing materials for possible re shipment Inspect the system components for damage If there is evidence of damage contact the carrier initiate a damage claim and inform ViVitro Labs The Data Acquisition System arrives with the following parts 1 AmPack pressure signal conditioner and amplifier 1 36 BNC Cable 3 12 BNC Cables 1 North American Power Cable 1 trim pot adjustment tool 2 I O Module analog to digital converter with 2 36 BNC Cables 3 12 BNC Cables 1 BNC T Adapter 1USB Cable 3 Laptop Computer 1 North American Power Cable 5 1 Installing the Data Acquisition System The components of the data acquisition system should be set up in a location which is protected from splash and spills
11. eldlantean tiestdandineteaidindeidsnteareieateudidaseaweideies 2 7 kg AMPLIFIER EASE OA VOM AB ee R R E O O no 2 5 volts 0 3 EXACTOS nord ete cian lt 20 mA PAN SCUCET Tesi aNG qui a ad any provided current lt 20 mA o NOTRE OR O 4 arm resistive or piezo resistive shear stress semiconductor MDL POS sernir E R A 10k ohms at 0 Hz CON OE area EEE EEE EEEE ENE EEEE EENE differential LOL eE E EEE EEE E E EE 0 1 full scale ARO AO E O O A 1 of value 8 hours 0 05 C AO SIA R O P O O O O 1 mmHg 8 hours 30 minute warm up common mode Te OE usarla gt 60 dB 0 60 Hz maximum common mode operating voltage ccccnnnnncocococonnnonononononanananonononononcnnnonanana nono 5 volts DC or peak AC Maximu saie TONE eean ENEE ESOO EEREN REE 12 volts DC or peak AC output noise mvolt sensitivity 33 mvolt mmHg oocccccnnnnnononononanonononnnnnnnnnananononnnnnnnnnnnnnanannnnnnss lt 0 1 mvolts freguency response MOCO OA ss O O eeu aa 0 200 kHz filtered 4 selections standard values are oocccocccnccnnccnnnccnncconcconoconoconoronanonnncnnonos O to 30 100 1000 10 000 Hz Zodisin said antec Kde ame EEEE EEEE 2 pole Butterworth 12 dB octave 40 dB decade optional filter modules are available output full scale rad 9 5 volts 23 mA max into 50 ohms capacitive loads to 100 pF ps o A e NP O E O N O thermal and short circuit O0 C COMA CLO O O V O O E A 9 pin female D subminiature OBCE CONNECTION z ra oh dpto tidad BNC Document
12. ers with the ViVitro Labs Inc Model AP9991 amplifiers e g Millar catheter tip MPC 500 9 Software For information on the software installed on the PC supplied with the Data Acquisition system refer to the system specific user manual ViViTest see Pulse Duplicator User Manual ViViGen see Pulse Duplicator User Manual HiTest see HiCycle User Manual or RWT User Manual a a i QCTest see Function Tester User Manual Document No 20157 A ViVitro Labs Inc 2014 Page 15 of 25 V V Data Acguisition System User Manual 10 Specifications 10 1 I O Module Model 08311 015 dh D5 0 E EE 5 VDC from USB x mW ETI LO 0 PRO ROP OP R V O O O O wx1xh 255 x 265 x 83 mm O O 1 85 kg Analog Inputs RAUB CS ssa Software selectable on a perchannel basis 10 V 5 V 2 V 1 V 0 5 V 0 2 V 0 1 V Input IMpPedantes sere 10 MOhm single ended 20 MOhm differential PP A BNC Digital Input NOU A ner oak mrt earner A a S tenner rrr mtr er o err o oo o perry o st 0 5 V TUE CO CPOE root BNC Analog Out TOMTO PER Po EEN A 16 bits Oo Ole cias 10 V A k oshisda olo a dest i ao kade E sknce the noe stpo t atd mA max KOJOT CORE O GOT Seem meee o o O re BNC 10 2 AmPack Model AP9991 Powersupply seri 115 230 10 volts AC switch selectable 50 60 Hz 10 watts PO Ue MOD A O case aa an eect O O II O O Y4 A MDL fuse PO ito aaa 255 x 150 x 130 mm total weight with three amplifiers inserted scctvevecciisnncicntuedecsard
13. from the test equipment The AmPack may be placed on top of the I O module Ensure the AmPack Is situated such that the on off switch located on the rear of the unit is accessible during operation NOTE Check your country s power supply amperage and voltage prior to connecting into a power supply ViVitro Labs Inc will endeavor to have your system s components adapted to meet your country s power supply however as an extra precaution it is advised that all equipment designated to be connected to a mains outlet be checked prior to use 1 Check that the voltage setting on the back panel of the Flow meter and AmPack are set for your supply voltage BEFORE connecting to the mains outlet Ensure that the operating voltage of the Heat Bath is correct for your region before connecting to the mains outlet Document No 20157 A ViVitro Labs Inc 2014 Page 7 of 25 V V Data Acguisition System User Manual 2 Where the voltage setting is incorrect adjust the setting manually according to the hardware s instructions The DAS is designed to be set up in the two following configurations 5 1 1 Pulse Duplicator Set Up For use with ViViTest and QC Test Software 1 Connect the pressure transducer cables to the inputs of the AmPack as follows a Aortic Red top b Ventricular Yellow middle c Atrial Blue bottom Connect the 3 12 BNC connectors to the outputs of the AmPack Connect the 3 12 BNC conncetors to following channel
14. holders and regulatory bodies that results are obtained by qualified personnel using traceable calibrated equipment and up to date test methods all supervised by a quality assurance department Document No 20157 A ViVitro Labs Inc 2014 Page 4 of 25 vit Data Acquisition System User Manual 2 Cautions and Warnings Document No 20157 A Prior to turning the AmPack on ensure the line voltage switch at the back is set to the correct value After you receive your Data Acquisition System ensure that you let the electrical enclosures sit indoors at room temperature for at least one day before plugging them in The systems must not be used in environments at higher than 75 humidity Ensure the AmPack is situated such that the on off switch located on the rear of the unit is accessible during operation Ensure the AmPack is situated with sufficient clearance gt 75mm at the rear to allow adequate air flow for cooling Read all of the instructions before operating the System This instrument is intended for research use only and must be operated by trained lab personnel Always connect the AmPack and PC power supplies to a grounded AC outlet using the AC power cords provided with the system Do not use an adapter to an ungrounded outlet Electrical devices pose the risk of electric shock To reduce the risk of shock do not open any covers that are fastened with screws Clean the exterior of the AmPack and I O Module housi
15. ltage on the back panel of the AmPack chassis for your line voltage Be sure to select 115 or 230 VAC appropriate to your line voltage AN INCORRECT VOLTAGE SETTING MAY CAUSE DAMAGE TO THE UNIT The fuse located on the rear panel should be 4A MDL Ensure the proper power cord for your countries outlet is available Insert the rectangular power plug into the rear panel receptacle The other end should be plugged into the mains supply Plug the white pressure transducer cables into the input connector on the front panel of the amplifiers Fasten all clamping screws using the trim pot adjuster tool to ensure optimum signal to noise ratio and stability Keep moisture away from all electrical connectors and the transducer case To power the unit on use the toggle switch on the rear panel Allow the amplifiers to warm up for 30 minutes to achieve minimum drift Warm up time can be avoided by leaving the unit on continuously This will not damage the system Select the desired filters using the filter switch located on the front panel of each amplifier For Pulse Duplicator measurements 30 Hz or 100 Hz is recommended For measurement of pressure in accelerated cycling tests 1000 Hz is recommended ront Panel Controls INPUT Always use the locking screws on the cable connectors GAIN Adjustable by 15 turn potentiometer FILTERS A five position switch selects upper frequency cut off Normally this should be lower SHIFT than
16. lted from i accident corruption misuse or neglect of the Software ii acts or omissions by someone other than ViVitro Labs ili combination of the Software with products material or software not provided by ViVitro Labs or not intended for combination with the Software or iv failure by you to incorporate and use all updates to the Software available from ViVitro Labs ViVitro Labs does not warrant that the Software or service will meet your requirements or that the operation of the Software will be uninterrupted or error free Document No 20157 A ViVitro Labs Inc 2014 Page 21 of 25 V V Data Acguisition System User Manual c Limitations on Warranties The express warranty set forth in 8 6 6 is the only warranty given by ViVitro Labs with respect to the Software and Documentation furnished hereunder and any service supplied from time to time ViVitro Labs and its licensors to the maximum extent permitted by applicable law make no other warranties express implied or arising by custom or trade usage and specifically disclaim the warranties of merchantability and fitness for a particular purpose In no event may you bring any claim action or proceeding arising out of the warranty set forth in 5 1 6 more than one year after the date on which the breach of warranty occurred d Limitations on Liability Except as reguired under local law the liability of ViVitro Labs and its licensors whether in contract tort including negligence
17. n direction input XDPCR Edge Rising XDPCR pin direction input g ADC settling time 10us 7 Click OK 8 Right click on the board number in the InstaCal box and select Calibrate A D 9 Click Calibrate 10 Click OK and Exit program gt o a 0 0 Document No 20157 A ViVitro Labs Inc 2014 Page 19 of 25 V V Data Acguisition System User Manual Appendix Ill End User License Agreement The terms and conditions that follow set forth a legal agreement between you either an individual or an entity and ViVitro Labs herein referred to as ViVitro Labs with its principal place of business at 455 Boleskine Road Victoria BC Canada V8Z 1E7 relating to the computer software known as ViViTest and certain other related software modules if applicable herein referred to as Software The term Software includes and these terms and conditions also apply to any updates or upgrades to the software that you may receive from time to time under a subscription service or other support arrangement You may not load or use the Software in any computer or copy it without a license from ViVitro Labs ViVitro Labs hereby offers you a non exclusive license on the terms set out in this Agreement You should carefully read these terms and conditions BEFORE opening the case that contains the Software or installing and using the Software Opening the case containing the Software or installing and using the Software will signify your agreeme
18. nditioner AP9991 2009 hereby declare that the device named above has been tested and found to comply with the above referenced Directives and Standards Name Position Done at On Document No 20157 A ViVitro Labs Inc 2014 Gerry Wight General Manager Victoria BC Canada 15 July 2014 Page 25 of 25
19. ngs with a dry cloth only Disconnect power before cleaning Use caution when moving the system Disconnect power before moving the system to a new location Do not use the system if there is evidence of physical damage or if the system has been dropped or subject to impact Do not attempt to service the product beyond what has been described in this manual All other servicing should be referred to qualified service personnel The user may opt to manipulate the system to achieve alternate states results configurations Should the user carry this out it should be noted that exceeding the specified limits may compromise the accuracy of the digitized signal ViVitro Labs Inc 2014 Page 5 of 25 V V Data Acguisition System User Manual 3 About this Manual This document describes the Data Acquisition System s procedures for Assembly of the system s hardware Connection of the system s electrical components Calibration and system setup Operator procedures for the system s daily use n l eae 4 About the Data Acquisition System 4 1 System Components The Data Acquisition System supplied by ViVitro Labs Inc consists of e O Module Inputs outputs signals from the software e AmPack Pressure Measuring System including transducers and amplifier e Laptop computer e Connecting cables e Software ViViTest HiTest or QCTest 4 2 Hardware Features The Data Acquisition System from ViVitro Labs Inc features includ
20. nnnonanernnnnnnns 21 6 Limited Warranty Exceptions Disclaimers ccoooonncncccccoccnnccononnnnncononcnnnnononcnnnnonnncnnnnonnnrnnnnnnnnnnnnnonannnnnnnnnns 21 7 European SOMWare DIRGCIIVG iii 22 8 Genera lNRrTOMISIONS csi roo 22 9 e ya ne sei ree voto tle ee ss ye psc dese O O O ssece 23 Appendix IV I O Module Declarations of Conformity ccccceceseesseeeseeeesseeeseeesseeeeseeenseeessonenneees 24 Appendix V AmPack Declarations of Conformity cccceeeeeeseccessseeeeeeeeeeceessseeeeeseeeoeanseeeeeeseeees 25 Document No 20157 A ViVitro Labs Inc 2014 Page 3 of 25 V V Data Acguisition System User Manual 1 About ViVitro Labs ViVitro Labs Inc offers industry leading cardiovascular test eguipment and related laboratory testing services Hundreds of organizations in over 39 countries for 30 years have trusted ViVitro s expertise accuracy and quality for their cardiovascular device testing As the developer of the world s first Pulse Duplicator the ViVitro name has been synonymous with cardiovascular device testing equipment ViVitro hardware and software products have been used by leading R amp D facilities and academic labs worldwide and its equipment and testing methods being cited in hundreds of peer reviewed publications http ViVitrolabs com company cited publications The ViVitro Labs Pulse Duplicator System in particular the ViVitro Labs SuperPump has become a worldwide standa
21. nt to be bound by these terms 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 is a license agreement and not an agreement for sale 1 Grant of License ViVitro Labs grants to you a nonexclusive license to use the Software and the printed and or electronic user documentation the Documentation accompanying the Software in accordance with this Agreement If you have paid the license fee for a single user license this Agreement permits you to use one copy of the Software on any single computer provided that the Software is in use on only one computer at any time The Software is in use on a computer when it is loaded into the temporary memory i e RAM If the potential number of users of the Software exceeds the number of licenses you have purchased then you must have a reasonable mechanism or process in place to assure that the number of computers on which the Software is running concurrently does not exceed the number of licenses purchased ViVitro Labs reserves the right to embed a software security mechanism within the Software to monitor usage of the software to verify your compliance with this license Such a security mechanism may store data relating to the use of the Software and the number of times it has been copied ViVitro Labs reserves the right to use a hardware lock device license administ
22. ottom and middle AmPack channels Connect the 2 12 BNC cables to the following channels on the I O Module a Outflow bottom to channel 0 b Inflow middle to channel 1 Connect the BNC T connector to channel 6 on the I O Module Connect one side of the T to channel 3 using a 12 BNC cable Connect one 36 BNC cable from the Sync output of the controller to the other side of the T Connect the USB cable between the I O Module and the Laptop computer Document No 20157 A ViVitro Labs Inc 2014 Page 10 of 25 Vitro Data Acquisition System User Manual e USB TO COMPUTER PRESSURE TRANSDUCER CABLE CH3 CH4 CHS LOOF CABLE m JUNCTION OUTPUT iw EE mo la O gt la 8 Document No 20157 A O ViVitro Labs Inc 2014 Page 11 of 25 SYNC Vitro Data Acquisition System User Manual A Ma r A A 4 p Y A A A Za A A i A AP P ACTUATOR CABLE Ma A 7 PA H a ha A A g AA oa A gt A A lt gt s A M SS gt a i o ix pe SS A fy h i i 1 HA T PA jj A P A y A A a PRESSURE TRANSDUCER CABLE SYNC OUT LOOP CABLE gw 033 238 gt O Document No 20157 A ViVitro Labs Inc 2014 Page 12 of 25 V V Data Acguisition System User Manual 6 AmPack Operation 6 1 Operation 1 NOTE NOTE 4 NOTE 6 2 F Set the vo
23. pplication 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 permissible and the remainder of this Agreement shall remain in full force and effect Document No 20157 A ViVitro Labs Inc 2014 Page 22 of 25 V V Data Acguisition System User Manual 9 Canadian Sales If you purchased this product in Canada you agree to the following The parties hereto confirm that it is their wish that this Agreement as well as other documents relating hereto including Notices have been and shall be written in the English language only Les parties aux pr sentes confirment leur volunt que cette convention de m me que tous les documents y compris tout avis qui s y rattache soient r dig s en langue anglaise You further agree that this Agreement is the complete and exclusive statement of your agreement with ViVitro Labs Inc relating to the Software and subscription service and supersedes any other agreement oral or written or any other communications between you and ViVitro Labs Inc relating to the Software and subscription service provided however that this Agreement shall not supersede the terms of any signed agreemen
24. priate uses of the 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 4 establishing adequate backup to prevent the loss of data in the event of a Software malfunction 6 Limited Warranty Exceptions amp Disclaimers a Limited Warranty ViVitro Labs warrants that the Software will be free of defects in materials and workmanship and will perform substantially in accordance with the Documentation for a period of ninety 90 days from the date of receipt by you ViVitro Labs also warrants that any services it provides from time to time will be performed in a work person like manner in accordance with reasonable commercial practice ViVitro Labs entire liability and your sole remedy under this warranty shall be to use reasonable efforts to repair or replace the nonconforming media or Software or re perform the service If such effort fails ViVitro Labs shall i refund the price you paid for the Software upon return of the nonconforming Software and a copy of your receipt or the price you paid for the service as appropriate or li provide such other remedy as may be required by law Any replacement Software will be warranted for the remainder of the original warranty period or thirty 80 days from the date of receipt by you whichever is longer b Exceptions ViVitro Labs limited warranty is void if breach of the warranty has resu
25. ration software and or a license authorization key to control access to the Software You may not take any steps to avoid or defeat the purpose of any such measures Use of any Software without any required lock device or authorization key is prohibited 2 Ownership of the Software Restrictions on Copying ViVitro Labs or its licensors own and will retain all copyright trademark trade secret and other proprietary rights in and to the Software and the Documentation THE SOFTWARE AND THE DOCUMENTATION ARE PROTECTED BY COPYRIGHT LAWS AND OTHER INTELLECTUAL PROPERTY LAWS You obtain only such rights as are specifically provided in this Agreement You may copy the Software into any machine readable form for back up purposes and within the license restrictions You may not remove from the Software or Documentation any copyright or other proprietary rights notice or any disclaimer and you shall reproduce on all copies of the Software made in accordance with this Agreement all such notices and disclaimers Document No 20157 A ViVitro Labs Inc 2014 Page 20 of 25 V V Data Acguisition System User Manual 3 Other Restrictions on Use This Agreement is your proof of license to exercise the rights granted herein and must be retained by you You may not use any portion of the Software separately from or independently of the Software and other than for your normal business purposes You may not provide access to or use of the Software to any thir
26. rd to simulate physiological heart conditions in academic research applications ViVitro products are manufactured by StarFish Medical in an ISO 13485 2003 certified manufacturing facility ViVitro Labs Inc also holds ISO IEC 17025 accreditation for laboratory testing services endorsed by A2LA and based on ISO 5840 This scope of accreditation includes the physical and mechanical testing of heart valve substitutes including durability hydrodynamic and flow visualization testing ViVitro Labs is widely recognized as the authority on cardiovascular device testing ViVitro Laboratory Services are engaged worldwide for hydrodynamic durability and flow visualization testing of heart valves and other cardiac devices ViVitro has been the trusted name in regulatory approvals for over 30 years and is renowned for its proven success from product development testing through to full regulatory submission ViVitro Labs is a member of the ISO 5840 standards committee and is actively engaged in developing regulatory requirements Leveraging this intimate knowledge of the standard ViVitro Labs ensures that test protocols will meet ever changing regulatory requirements ViVitro s Laboratory Testing Services offers an ISO IEC 17025 certified lab using ViVitro equipment to conduct 3 party independent testing ViVitro s accredited testing lab is governed by a mature Quality Management System QMS certified to meet the ISO 5840 This gives assurance to stake
27. s of the I O Module a Aortic top to channel 0 b Ventricular middle to channel 1 c Atrial bottom to channel 2 4 Connect the 36 BNC cable provided in the Flow Meter box to channel 4 of the I O module Connect the other end to the Pulse port on the Flow Measuring System 5 Attach the ground wire to the Pulse Duplicator and plug it into the Flow Measuring system Connect the flow probe cable to meter Connect one 36 BNC cable to the Position port on the controller and connect the other end to channel 5 on the I O module 8 Connect one 36 BNC cable to the DL DT port on the controller and connect the other end to channel 3 on the I O module 9 Connect one 36 BNC cable to the Waveform In port on the controller and connect the other end to analog output chanel 0 on the I O module 10 Connect the USB cable between the I O Module and the Laptop computer Document No 20157 A ViVitro Labs Inc 2014 Page 8 of 25 T it A O Data Acquisition System User Manual a DS inc USB TO COMPUTER alll VENT RIC OUTPUT 9 eeeees73e 0 o VO MODULE DRIVE OUTPUT Document No 20157 A ViVitro Labs Inc 2014 Page 9 of 25 V V Data Acguisition System User Manual 5 1 2 HiCycle RWT Set Up For use with HiTest Software Connect the pressure transducer cables to the inputs of the AmPack as follows a Outflow Red bottom b Inflow Blue middle Connect 2 12 BNC cables to the outputs of the b
28. t between you and ViVitro Labs Inc relating to the Software and subscription service ViVitro Labs warrants all parts of its own manufacture to be free from defects in material and workmanship under normal use and service in a suitable environment for the period of one year after delivery Document No 20157 A ViVitro Labs Inc 2014 Page 23 of 25 V V Data Acguisition System User Manual Appendix IV I O Module Declarations of Conformity Application of Council Directives Standards to which conformity is declared Manufacturer Type of device Model Year of initial CE Marking CE 2004 108 EC EN 61326 1 2013 ViVitro Labs Inc 455 Boleskine Road Victoria BC V8Z 1E7 Canada Analog Digital Converter 08311 2014 I hereby declare that the device named above has been tested and found to comply with the above referenced Directives and Standards Name Position Done at On Document No 20157 A ViVitro Labs Inc 2014 Gerry Wight General Manager Victoria BC Canada 15 July 2014 Page 24 of 25 V V Data Acguisition System User Manual Appendix V AmPack Declarations of Conformity Application of Council Directives Standards to which conformity is declared Manufacturer Type of device Model Year of initial CE Marking CE 2006 95 EC 2004 108 EC EN 61010 1 2010 EN 61326 1 2013 ViVitro Labs Inc 455 Boleskine Road Victoria BC V8Z 1E7 Canada Transducer Signal Co
29. ting specifying the nature of the Interoperability Information you need and the purpose for which it will be used If ViVitro Labs reasonably determines that you are entitled to such Interoperability Information under the Software Directive ViVitro Labs Inc shall at its option either i provide such Interoperability Information to you or ii allow you to reverse engineer the Software within the limits and for the purposes prescribed by the Software Directive solely to the extent indispensable to obtain such Interoperability Information If ViVitro Labs Inc elects clause i you will provide any information and assistance reasonably requested by ViVitro Labs Inc to enable ViVitro Labs Inc to perform clause i and ViVitro Labs Inc may charge you a reasonable fee for making available the requested Interoperability Information unless such a fee is prohibited under the Software Directive 8 General Provisions You acknowledge that the Software and the Documentation may be subject to the export control laws of the United States or the United Kingdom and agree not to export or re export the Software or the Documentation i e move the Software from the country in which you first licensed it without the appropriate United States or foreign government licenses and the written approval of ViVitro Labs Inc and its licensors The United Nations Convention on Contracts for the International Sale of Goods 1980 is here by excluded in its entirety from a
30. uisition System User Manual Appendix AmPack Calibration Each amplifier module and pressure transducer may be calibrated following the procedure given below You will need a reference pressure gauge A manometer with a range of at least 250 mmHg and accuracy of at minimum 0 025 is suitable You will need a means of reading amplifier output between 10 00 and 10 00 volts DC to an accuracy gt than the pressure gauge accuracy Use the supplied trim pot tool to adjust the 15 turn potentiometers for GAIN amp SHIFT The extreme position indicated by a click may be located by rotation of at least 15 turns clockwise or anti clockwise Ensure the AmPack has been on for at least 30 minutes prior to calibration to prevent drift A two point pressure transducer calibration can be made as follows 1 Connect amplifiers to pressure transducers and switch amplifier chassis power ON 2 Use a syringe to fill the pressure transducers with distilled water 3 Adjust the SHIFT control to give the desired voltage output at 0 mmHg gage pressure atmospheric a 5 9 to 6 1 VDC for Pulse Duplicator b 0 9 to 1 1 VDC for HiCycle RWT 4 Apply a pressure of 200 mmHg to transducers and adjust GAIN for the target voltage output a 5 9 to 6 1 VDC for Pulse Duplicator b 6 9 to 7 1 VDC for HiCycle RWT 5 Repeat steps 3 and 4 the desired sttings at both limits are achieved 6 Below are the approximate values that will be achieved from the calibrations
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