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SR-200 SuperPump AR Series Manual

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1. Any communications failures or other problems will be signalled here Note that an attempt to communicate with the amplifier will be repeated until successful or the software is terminated Note If the USB is disconnected and then reconnected the Refresh Status will not update The SuperPump must be reconnected using drop down menu in upper left corner 9 5 New waveform creation New waveforms may be created using the drop down menu from the WEEN label in the upper left corner Select New and complete the requested data in the Create New Waveforms window Note that 1024 is the standard and expected number of Points Enter its Label name its Beat Rate and its Waveform Type Select the Save icon and name the file appropriately Select Done when completed The new waveform may now be accessed from one of the five index positions and the duty cycle and beat rate adjusted as required www vivitrolabs com Page 22 of 26 9 6 Software 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 con
2. SuperPump System User Manual AR Series SFPart 17476 B ViVdoc SR 200 1 0 ViVitro Labs SuperPump AR series 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 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 V8Z 1E7 Canada tel 250 388 3531 fax 250 483 1975 e mail support vivitrolabs com 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 content
3. fc 19 om gl 61 1 O50 0 4 ne hn ee ee a eee E ene aes 13 AsO PUND ODS ON DE 13 4T Cleaning ees E nee ene E eee 15 5 Faults Te ET CN 14 Sal EMO CIC e see sone caniseees ce tsessaeneseuese E 14 ye un SWIC ES E P A PE A E A E A EE S E 14 IS PUMPEN E 14 6 Specifications sanssnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn mennenm nn 15 Site 8 Oe Et dite EC 20 TA MOUNTING TEC DOI DANCIN seeni a tcnsaau canst a a 20 7 2 Pump cylinder mounting face bolt Pattern cc cccceececeeeeseeeseeeeseeeeseeeseueeseeesaeeess 20 8 MIVIGEN SON ANC ouire enana E EEEE ENANA IEEE TENAN 21 2 O aa E E E E 21 o NERO ee een er ene eS inert eet et een ee ee 21 Oxo ER 21 E latus 216 TEE 22 8 5 INCW Wav Giron CreatiOn cab segostetcagectecaccnccaesetessisascascad aaea aE AOSA 22 8 6 Software License Agreement 23 www vivitrolabs com Page 4 of 26 1 Cautions and Warnings Read all of the instructions before operating the SuperPump This instrument is intended for research use only and must be operated by trained lab personnel To ensure adequate cooling of the SuperPump controller and pump place on a clean flat surface and be sure that there is at least 10 cm 4 in of clearance around each side of the controller and motor end of the pump Make sure that the fan vent is not blocked Always connect the power supply to a 3 prong grounded AC outlet rated 4A 110 240 V using the AC power cord provided with the SuperPump Do
4. implied or arising by custom or trade usage and specifically disclaim the warranties of merchantability and fitness for a particular purpose In no event may you bring any claim action or proceeding arising out of the warranty set forth in 5 1 6 more than one year after the date on which the breach of warranty occurred d Limitations on Liability Except as required under local law the liability of ViVitro Labs and its licensors whether in contract tort including negligence or otherwise arising out of or in connection with the Software or Documentation furnished hereunder and any service supplied from time to time shall not exceed the 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 consequential damages including without limitation damages resulting from loss of use loss of data loss of profits loss of goodwill or loss of business arising out of or in connection with the use of or inability to use the Software or Documentation furnished hereunder and any service supplied from time to time even if ViVitro Labs or its licensors have been advised of the 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 9 6 7 European Software Direc
5. 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 resulted from i accident corruption misuse or neglect of the Software ii acts or omissions by someone other than ViVitro Labs iil 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 www vivitrolabs com Page 24 of 26 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
6. To the left of the display is the menu knob which allows scrolling by turning the knob and selection by pressing the knob To the right of the display is the amplitude knob which adjusts the amplitude of the output waveform and starts and stops the pump by pressing the knob 3 4 Rear Panel The rear panel contains all of the connectors From left to right e Waveform In BNC connector used when an external signal is used as the waveform e Position BNC connector analog output signal for the piston position e dl dt BNC connector analog output signal proportional to instantaneous flow rate e Sync Out BNC connector 5V TTL signal triggered at the rising zero crossing of the waveform The timing of the signal can be adjusted to any point in the waveform e Troubleshooting port no user accessible functions e USB For uploading custom waveforms created using ViVigen software or for use with ViVitest when the SuperPump is used as part of the Pulse Duplicator e Motor Cable connection to the pump e Cooling fan e Power input Power cord fuse holder and main power on off www vivitrolabs com Page 8 of 26 3 5 Electrical Requirements ViVitro Labs Inc will endeavor to have your system s components adapted to meet your country s power supply however as an extra precaution it is advised that all equipment designated to be connected to a power supply be checked prior to use Use only the power cord supplied with your SuperPump The co
7. dicate the most recently used waveform source If the current waveform source is desired press the dial again to escape the waveform selector If a stored waveform is desired turn the dial clockwise and press the dial when you have chosen the correct waveform Refer to Section 8 ViVigen to load standard waveforms edit or create waveforms and load them onto the SuperPump Controller 4 4 Set Sync Delay Press the Menu Selector Dial Turn the menu knob until 2 Sync Pulse Delay is on the screen press the dial again The screen will now indicate the current sync delay in msec To adjust the delay turn the dial until the correct delay is displayed and then press the dial www vivitrolabs com Page 12 of 26 4 5 Change the Cycle Count Press the Menu Selector Dial Turn the menu knob until 3 Totalizer is on the screen press the dial again To adjust the counter turn the dial until the correct value is displayed and then press the dial 4 6 Pump Operation Turn the Amplitude Dial until the desired stroke volume is reached For example To stop the pump either turn the Amplitude Dial to 0 or press the Amplitude Dial In this case an Emergency Stop alarm will appear To clear this alarm press the Amplitude Dial The pump will automatically perform a Homing Sequence www vivitrolabs com Page 13 of 26 5 Faults and Alarms 5 1 Emergency Stop If case of an Emergency Stop press the Amplitude Dial to clear
8. ditions also apply to any updates or upgrades to the Software that you may receive from time to time under a subscription service or other support arrangement You may not load or use the Software in any computer or copy it without a license from ViVitro Labs ViVitro Labs hereby offers you a non exclusive license on the terms set out in this Agreement You should carefully read these terms and conditions BEFORE opening the case that contains the Software or installing and using the Software Opening the case containing the Software or installing and using the software will signify your agreement to be bound by these terms and conditions If you do 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 9 6 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 n
9. gue anglaise You further agree that this Agreement is the complete and exclusive statement of your agreement with ViVitro Labs Inc relating to the Software and subscription service and supersedes any other agreement oral or written or any other communications between you and ViVitro Labs Inc relating to the Software and subscription service provided however that this Agreement shall not supersede the terms of any signed agreement between you and ViVitro Labs Inc relating to the Software and subscription service ViVitro Labs warrants all parts of its own manufacture to be free from defects in material and workmanship under normal use and service in a suitable environment for the period of one year after delivery www vivitrolabs com Page 26 of 26
10. he pump piston is located by a ball screw servo motor encoder unit driven by a motor controller which compares actual position against the desired position defined by the input waveform The precision of the ball screw and the resolution of the encoder ensure accurate positioning of the piston resulting in the desired pulsatile flow The controller can be used stand alone by selecting one of the built in waveforms or an external signal can be input ViVigen software is included with the pump to allow the generation of custom waveforms which can then be uploaded to the controller via the built in USB port The SuperPump is designed for use as part of the ViVitro Pulse Duplicator and includes the required inputs and outputs for this These same I O including analog outputs for position dl dt flow and the sync pulse make the SuperPump adaptable to any custom test apparatus The ViVitro Labs AR series SuperPump is ideal for testing a variety of cardiovascular devices 2 2 Features The SuperPump AR series from ViVitro Labs Inc features include e Digital precision control of a pump in cylinder designed linear actuator used to generate physiological flows e Stand alone capability with five 5 preprogrammed cardiac waveforms created by user e Range of capable rates are 4 to 200 beats per minute e Range of stroke volume 0 to 150 ml e Digital controlled and created waveforms by ViViGen or ViViTest software e Control create input or store cardiac wa
11. hort Extrusion 08981 onto the pump The gap in the short extrusion should be in line with the longer flat section of the central stand Short Extrusion 08981 Note orientation 14 Push O Ring 235 SPM072 into the groove on the outside face of End Cap 08975 15 Push O Ring 335 10084 into the groove on the inside face of End Cap 08975 www vivitrolabs com Page 17 of 26 Long flat section Inside Face 16 Fasten the End Cap 08975 onto the pump head with four 20 x 4 5 SHCS 08980 Take care not to chip the edge of the glass with the aluminum parts Tighten the fasteners gradually to prevent uneven stress on the glass cylinder Compress the sides of the Short Extrusion 08981 while tightening so that the sides sit flush with the end cap faces Outside Face Ya 20 x 4 5 17 Check for damage on O Ring 09534 into the recess of the SuperPump Piston Cap 09533 18 Fasten the SuperPump Piston Cap 09533 to the SuperPump Piston with three 6 32 x SHCS HCM079 Loctite is not required www vivitrolabs com Page 18 of 26 7 Specifications Pump bore diameter Nominal GO Gamm 2 750 Maximum pressure External Waveform 5V 0 067 Hz to 3 33 Hz 4 to 200 beats per minute Outputs Position 5 to 5 V 200mV mm dl dt 5 to 5 V 539 ml s V Sync 5V TTL LE at rising zero crossing Operating Temperature Operating Humidity Operating pressure elevation Shipping Storage Tempera
12. il 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 9 6 5 Responsibility for Selection and Use of Software You are responsible for the supervision management and control of the use of the Software and output of the Software including but not limited to 1 selection of the Software to achieve your intended results 2 determining the appropriate uses of the Software and the output of the 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 9 6 6 Limited Warranty Exceptions A 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
13. lash drive with ViVigen software 3 2 Installing the SuperPump The SuperPump is supplied mounted to a rigid plastic base for use on a bench top Optionally the pump may be mounted directly to a structure or test apparatus using 10 32 fasteners through the mounting feet of the pump See bolt pattern layout at the end of the document lt is recommended that the SuperPump be mounted horizontally The back side of the pump cylinder is provided with a drain however vertical mounting of the pump can result in water entering the ball screw motor causing an electrical hazard The controller should be located away from the pump to avoid any water or test fluid An extension cable is provided to allow extra separation if required It is recommended that the pump act on the test fluid through a membrane to maintain isolation between working and test fluid The piston should not be directly exposed to blood analog solution or saline Distilled water is recommended as the working fluid When connecting the controller to other equipment such as computers or a signal generator ensure all equipment is on the same ground Ground loops can cause noise or signal offsets which will result in a noisy or inconsistent waveform Any test setup should be validated by running known samples before testing www vivitrolabs com Page 7 of 26 3 3 Front Panel The front panel consists of 2 controls and the display The controls are rotary encoders with push switches
14. not use an adapter to an ungrounded outlet Before plugging the instrument in be sure that the correct fuses are installed See section 3 6 Electrical devices pose the risk of electric shock To reduce the risk of shock do not open any covers that are fastened with screws While SuperPumpis designed to withstand spills on its exterior surface do not allow fluids to enter the interior of the instrument In the event of such a spill disconnect the power cable before cleaning up Do not operate SuperPump in extreme humidity or in conditions that can create condensation Protect the instrument against dust and moisture and avoid physical shock and strong forces Clean the controller and pump exterior with a dry cloth Disconnect power before cleaning Use caution when moving the controller and or pump Disconnect power and pump cable before moving the system to a new location Do not use the SuperPump 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 www vivitrolabs com Page 5 of 26 2 About the AR series SuperPump 2 1 System Hardware The Advanced Research series SuperPump System made by ViVitro Labs Inc consists of a digital amplifier with stroke volume display and preprogrammed waveforms driving a piston in cylinder pump T
15. ntroller must be plugged into a grounded outlet rated for 300W 3 6 Fuses Two fuses are supplied and required for the SuperPump Controller They are located in the fuse drawer on the power input module on the back of the controller At 120VAC use two 4A 5mm x 20mm 230V fuses At 230VAC use two 2A 5mm x 20mm 230V fuses Contact ViVitro Labs if you require replacement fuses www vivitrolabs com Page 9 of 26 4 Running the System 4 1 Waveform Source The SuperPump may be operated using either a USB connection to a computer running ViViTest Software see ViViTest user manual b Internally stored waveform see section 8 ViVigen c Externally generated waveform If an external waveform is to be used plug an appropriate BNC cable from the waveform source to the Waveform In port on the back of the SuperPump Controller sec 2 4 The external waveform should conform to the following specifications e Amplitude 5 0 V maximum Any waveform that exceeds this amplitude will not be accurately represented in the pump movement e Rate Frequency 4 bom beats per minute minimum to 200 bom maximum 0 067 Hz to 3 33 Hz NOTE Do not input waveforms with frequency greater than the listed maximum e Form Bi polar The waveform should be centered about 0 V ground without D C offset unless offset is intended for recreating a particular wave shape The peak to peak limits with offset must still remain within 5 0 V relative to g
16. 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 Le move the Software from the country in which you first licensed it without the appropriate United States or foreign government licenses and the written approval of ViVitro Labs Inc and its licensors The United Nations Convention on Contracts for the International Sale of Goods 1980 is here by excluded in its entirety from application to this License Agreement The English 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 www vivitrolabs com Page 25 of 26 9 6 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 lan
17. rPump has become a worldwide standard for the generation of physiological pressure waveforms in academic research applications Laboratory and Production Services Almost every significant prosthetic valve company in the world has ViVitro Labs equipment in their research laboratories ViVitro Labs services include e Verification of Hydrodynamic Testing ISO 5840 2005 Annex L e Durability Testing ISO 5840 2005 Annex M e And other design specific testing Other Product Services ViVitro Labs also provides a variety of product services which are found in many manufacturers production and QC systems ViVitro Labs product services include e Customized testing systems e Custom production function testers e QC test and inspection equipment www vivitrolabs com Page 3 of 26 Contents 1 Cautions and VV AU e EE 5 2 About the AR series SUPCrPUMDP 111 cceeceeceeseneeneeeeneeeeeneeeesseeenseeeeneeeoneeseaseeseasesonnensoes 6 2 1 SYSTEM Hardware 6 2 WC ASS spe ecoctet es retrecticteystecioctncte AEE EE EEE AEE E 6 3 Initial Set Up Procedures EE 7 3 1 Unpacking list Of components ccccceecceeeceeeeeeeeeeeeeeeeeeeeeeeseeeseeeeeeesaeeeeeeseeesaeees 7 3 2 Installing the ZGuperbump 7 33 deu 1 0 lt n eee ee eee 8 3A Rear a E 8 3 5 Electrical Requirements A 9 SE 9 4 RUNNING the System EEN 10 4 1 Waveform Gource ke NENNEN ENEE En 10 Ace Inialze Systemi EE 11 e SOIOCL VV AVC IONIAN EE 12 44 SO OVC RE 12 AS
18. refully remove the glass cylinder from the piston CAUTION DURING THIS STEP BE CAREFUL WHEN HANDLING THE GLASS CYLINDER AS THE EDGES MAY BE SHARP 5 Remove the M10 nut and lockwasher from the front of the piston 6 Remove the SuperPump Piston 09532 from the rod end Piston Seal 7 Locate the small hole near the outer edge of the piston Holding the piston firmly press off the piston seal with a small hex key Be sure not to scratch or damage the piston sealing surface during this step Push from this face Piston Sealing Surface 8 Check the sealing surface of the piston for scratches that are either visible or can be felt with a fingernail Ensuring the orientation is correct snap the piston seal onto the piston carefully by hand www vivitrolabs com Page 16 of 26 9 Clean any dust and debris from the glass cylinder Apply two pieces of electrical tape to one edge of the glass cylinder 10 Push the piston into the glass cylinder SPM042 using the tape as a glide point Remove the electrical tape from the Glass Cylinder SPM042 11 Slide rod end into the SuperPump Piston 09532 Fasten in place with a M10 Lock Washer 09538 Loctite and the nut from the rod end Ensure the glass cylinder does not bump against the cylinder rod M10 Nut and Lock Washer 12 Push the Glass Cylinder SPM042 onto the pump Ensure that the piston does not come close to the sharp edge of the glass cylinder 13 Place the S
19. round e Noise and Distortion both noise and distortion will affect the accuracy of the pump movement therefore the signal source should be clean with THD N total harmonic distortion and noise below 5 Note the maximum velocity of the piston is limited to approximately 6 0mm sec As amplitude and frequency are increased the velocity will also increase If the pump cannot match the desired waveform a pump error will result In this case either the maximum slope of the waveform must be reduced or the frequency or amplitude must be reduced www vivitrolabs com Page 10 of 26 4 2 Initialize System Turn on the power switch on the back of the Controller The screen on the front of the Controller will light up and indicate that it is Initializing It will then automatically begin a Homing Pump sequence Kl B i LNS D o Firmware Version Programming oo Date A Tab an Bu i ch NV HRS qe Menu Amplitude Selector Dial After automatically Homing Pump the screen should appear as below The most recently used waveform source will appear in the Current Waveform section Current Amplitude Current Stroke Volume Amplitude Current Sync Output Waveform Delay www vivitrolabs com Page 11 of 26 4 3 Select Waveform Press the Menu Selector Dial Turn the Menu dial until 1 Waveform Source appears as below While the message Waveform Source is on the screen press the dial again The screen will now in
20. s 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 9 6 3 Other Restrictions on Use www vivitrolabs com Page 23 of 26 This Agreement is your proof of license to exercise the rights granted herein and must be retained by you You may not use any portion of the Software separately from or independently of the Software and other than for your normal business purposes You may not provide access to or use of the Software to any third party consequently you may not sell license sublicense transfer assign lease or rent including via an application service provider ASP or timeshare 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 9 6 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 fa
21. s of this document and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose No warranty may be created or extended by sales representatives or written sales material The advice and strategies contained herein may not be suitable for your situation Neither the Publisher nor author shall be liable for any loss of profit or any other commercial damages including but not limited to special incidental consequential or other damages ViVitro Labs Inc t 250 388 3531 f 250 483 1975 455 Boleskine Rd Victoria BC V8Z 1E7 Canada www vivitrolabs com Page 2 of 26 About ViVitro Labs ViVitro Labs offers industry leading prosthetic heart valve test equipment and related testing and consulting services Since our formation in 1984 we have worked closely with our clients universities medical device manufacturers and regulatory agencies to support their research regulatory and production requirements Our vision is to empower our clients to complete world leading research develop high quality innovative products and ensure that they demonstrate regulatory compliance What we offer ViVitro Labs respected clients come from all over the world and include leaders in the cardiovascular implant industry Academic Research ViVitro Labs is a leading vendor to academic labs worldwide Hundreds of citations refer to the use of ViVitro Labs equipment For example the ViVitro Labs Supe
22. t is possible to modify these waveforms using the four icons and the drop down boxes for each position www vivitrolabs com Page 21 of 26 Use the Open File icon the file and view the waveform on the graph to search for a stored waveform in the software package Open Use the Tools icon ya to modify or edit the waveform its label or its Beat Rate Be sure to define the Type and Duty Cycle under the Edit Waveform Tools Note The Beat Rate has a max value of 400 Do not use a beat rate higher than 200 when running the SuperPump Use the Save icon Led to save the modified waveform to a file Use the Refresh icon ON to view your changes Note Remember to save your waveform before using the Refresh icon when making changes under Edit Waveform Tools Use the Send icon Ss to send the waveform to the amplifier Note Do not attempt to Refresh or Upload a waveform when the SuperPump is running 9 4 Status Request Use the Refresh icon fe beside the SuperPump Status label to update the screen view with the current status of the pump Note the amplitude number represents a percentage value not a stroke volume Waveform index gives the index number of the waveform currently being used by the amplifier sync pulse delay is given in milliseconds and can be adjusted using the amplifier controls Observe the error code box under the SuperPump Status
23. the alarm and Home the pump 5 2 Limit Switch The SuperPump actuator contains a factory set limit sensor for the maximum push and pull stroke In case of a Limit reached alarm press the Amplitude Dial to clear the alarm and Home the pump 5 3 Pump Error lf the Controller loses communication with the Pump or if the Pump is unable to move a Pump error message will appear If this occurs turn off the system check that the cables are properly installed ensure that the pump is free of mechanical interference and damage turn the controller on and allow it to initialize normally lf the alarm persists contact the manufacturer Vi ee www vivitrolabs com Page 14 of 26 6 Maintenance and Cleaning 6 1 Cleaning The controller outer surface should be cleaned with a dry cloth only The outer surface should be cleaned with a dry cloth only The pump cylinder may be flushed with distilled water or in the case of contamination mild detergent and water followed by rinsing with distilled water 6 2 Piston Seal Replacement 1 Remove the three 6 32 x 3 3 screws located on the front of the piston and remove the SuperPump Piston Cap 09533 6 32 x SHCS Piston Cap 2 Remove the four 20 x 4 5 screws on the front of the pump head Ya 20 x 4 5 3 Remove the Short Extrusion 08981 and end cap from the pump assembly www vivitrolabs com Page 15 of 26 M10 Nut and Lock Washer 4 Ca
24. tive If the provisions of the Council of European Communities Directive of May 14 1991 on the Legal Protection of Computer Programs as implemented in applicable national legislation the Software Directive apply to your use of the Software and you wish to obtain the information necessary to achieve interoperability of an independently created computer program with the Software as permitted under the Software Directive Interoperability Information you must notify ViVitro Labs in writing specifying the nature of the Interoperability 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 9 6 8 General Provisions You acknowledge that the Software and the D
25. ture Shipping Storage Humidity www vivitrolabs com Page 19 of 26 8 Pump Mounting Details 8 1 Mounting feet bolt pattern 391 3 lt i m ta UPPER MOUNTING HOLES 4 X 10 32 X 14mm DEEP FOOT MOUNTING HOLES 4X 5 1mm THRU 8 2 Pump cylinder mounting face bolt pattern 6x 4 5 THRU ON 102 26 mm BCD www vivitrolabs com Page 20 of 26 9 ViviGen Software ViVitro ViViGen Waveform Generator 300 400 500 600 700 800 900 Data Points 9 1 Installation Install the ViVigen Installer exe on the computer This executable program can be found on the supplied flash drive During installation setup check the box Create a desktop icon 9 2 Method Connect the SuperPump Amplifier to the computer using the USB cable Turn on the amplifier Open the ViViGen shortcut icon on the desktop Click the KEIdudlabel on the upper left corner to access the drop down menu Select Connect and select a COMX value If the connection is successful the red dot will turn green Click the eisai label on the upper left corner to access the drop down menu Select Refresh Waveforms to upload current waveforms from the amplifier to the Waveform Generator console The amplifier and the console are able to access five waveforms 9 3 Icons The left side of the console panel shows five index positions These correspond to the five waveforms stored in the amplifier I
26. umber of licenses you have purchased then you must have a reasonable mechanism or process in place to assure that the number of computers on which the Software is running concurrently does not exceed the number of licenses purchased ViVitro Labs reserves the right to embed a software security mechanism within the Software to monitor usage of the software to verify your compliance with this license Such a security mechanism may store data relating to the use of the Software and the number of times it has been copied ViVitro Labs reserves the right to use a hardware lock device license administration software and or a license authorization key to 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 9 6 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 right
27. veforms at various physiological states and frequencies through ViVitro software or other std waveform generating equipment e Manufactured by an ISO 13485 accredited facility designed to meet regulatory requirements ISO 5840 and FDA or research needs NOTE The user may opt to manipulate the system to _ achieve _ alternate states results configurations Should the user carry this out it should be noted that the pressures and flows are kept within the limitations of the system to ensure the system is not overloaded www vivitrolabs com Page 6 of 26 3 Initial Set Up Procedures The SuperPump System has several steps to the main mechanical sub assemblies and a few steps for the electrical components installation configuration NOTE Itis critical for the assembly steps to be followed in order to assure successful operation 3 1 Unpacking list of components The SuperPump AR arrives in 2 containers a wooden shipping crate for the pump and a cardboard container for the controller Inspect the shipping containers for external damage Retain the shipping carton and packing materials for possible re shipment Inspect the system components for damage If there is evidence of damage contact the carrier initiate a damage claim and inform ViVitro Labs The SuperPump arrives pre assembled with the following parts e Mounting base e Linear Actuator with Cable e Standard Pump Head e Actuator Extension Cable e SuperPump Controller e USB f

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