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Instructions for Use WAVES

1. O Le Pas L U m Pulsatile Heatexchan pump ger base Controller ne Coa Coolant Ice mp Container pu Cow Gea Display Power P User Interface Center WAVES control unit gt Bidirectional communication Unidirectional communication Figure 20 WAVES block diagram Page 136 of 139 Controller Alarm The controller directs all components of the system to be able to measure display and store parameters The controller also includes a clock The readings are compared with alarm limits visual and audible alarms are triggered if the limits are exceeded Display User Interface The Touchpad display allows you to follow the perfusion protocol and adjust the pulse pump rates by changing the systolic pressure It permits one to enter all perfusion data and parameters such as user name perfusion number set perfusion pressure and pressure regulation mode The display also shows the perfusion data systolic pressure diastolic pressure main pressure flow renal resistance perfusate temperature battery charge level in real time The user can note when an alarms occurs alarm message box and highlighted values and one has access to different graphic and numeric representations of data flow pressure temperature renal resistance The user interface allows one to save or transfer data by USB or network Audio Alarm The alarm sounds in the event of an alarm condition The audio a
2. 5 0 C Batteries status Total B1 B2 B3 B4 75 15 98 99 99 l Iransport 15 5hours 0 5hours 5hours 5hours 5hours T 27 mmHg DIA 20 row 120 ml min res 0 22 J This screen is displayed if you push the T battery symbol during a perfusion You can see the state of each battery Percentage of charge of each battery and Number of hours remaining for each battery A global percentage of charge and number of hours remaining is also available This message box is displayed for 5 seconds and disappears Page 68 of 139 e OPTION SCREEN Options Trend History p A na Coolant Drain This screen is displayed when you push on the Options button on the Main Perfusion screen during a perfusion Pushing the Trend button you can have access to different trends for the current perfusion systolic diastolic flow renal resistance See Trend screen Pushing the History button you can have access to the previous perfusion data stored in the memory See Perfusion history screen Pushing the Drain button you can drain the ice compartment See Coolant drain screen This control permits to drain the water and replace the ice in the ice compartment during a perfusion By pushing Back you can go to the previous step Main Perfusion screen Page 69 of 139 e TREND SCREENS Press Flow 100 80 mLimin This screen appears when you push on the T
3. 138 INTRODUCTION The WAVES is a two part kidney preservation and evaluation system which includes a control unit for monitoring pulsatile perfusion of one kidney The system is comprised of 1 a control unit further referenced by WAVES or WAVES control unit and 2 a sterile disposable single use cassette further referenced by Waters Cassette Module or WCM to aseptically store the kidney Finally a machine perfusate designed for use in a perfusion device is added to the WCM and circulated though the kidney during the preservation period and during transport 1 2 The WAVES control unit is a self contained unit for monitoring the perfusion and or transportation of the kidney The control unit is necessary for the WCM cassette to function properly The WCM cassette is an organ container which employs a circulation system consisting of the organ chamber venous and arterial reservoir bubble trap integrated temperature and pressure sensors membrane oxygenator heat exchanger and pulsatile pump head The cassette provides circulation of up to one liter of perfusate to one kidney The WCM is specifically designed for the control unit and no other cassette will fit into the control unit Contents Included WAVES Control Unit Instruction Manual Batteries 4 Power Cord USB Flash Drive Adapter for air port For a complete list of available accessories for the WAVES please contact Waters Medical Systems Customer Se
4. INE Y PSUS UY OLNI MALANNI LLANE READ THE INSTRUCTION MANUAL BEFORE OPERATING THE DEVICE TO PREVENT ANY SAFETY RISK AND DEVICE DETERIORATION A Institut Georges Lopez C E EC REP 1 all e des Chevreuils 0459 69380 Lissieu France Page 1 of 139 This user manual is made for the WAVES system For technical clinical or commercial support please contact our Clinical Support Customer Service team Technical or Clinical Support Waters Medical Systems WMS technicians and clinical support staff are available 24 hours per day to assist customers Customer Service WMS provides toll free telephone support to assist with product information To place an order for a perfusion device to order replacement parts or to order disposable components call Customer Service The following numbers can be used for technical and non technical support 800 426 9877 24 hours support number 00 1 507 252 3784 International 1 507 252 3700 Facsimile www igl group com Website information contact wtrs com Email Manufacturer WATERS MEDICAL SYSTEMS LLC 2112 15 St NW Rochester MN 55901 6117 USA Returning Equipment Should a customer need to return a device for maintenance or request a replacement disposable part please contact us using the 24 Hour Support Number Please return any disposable part that needs to be replaced to WMS for inspection Many questions can be answered by telephone and we suggest customers call before shi
5. WARNINGS e During non clinical transport no organ being perfused DO NOT SHIP THE WAVES TO WMS WITH THE LI ION BATTERIES INSIDE THE UNIT FIRE OR DAMAGE MAY RESULT TO THE WAVES AND VOID WARRANTY e SHOCK HAZARD NOT USER SERVICABLE WARRANTY WILL BE TERMINATED e EXPLOSION RISKS DO NOT USE THE WAVES IN THE PRESENCE OF FLAMMABLE ANESTHETICS e USE ONLY HOSPITAL GRADE POWER CORD WITH GROUND e THE WAVES MUST BE CONNECTED TO A RECEPTACLE MARKED HOSPITAL GRADE e USE PROPER LIFTING TECHNIQUES AND THE WAVES TRANSPORT BAG TO LIMIT POTENTIAL INJURY e USE UNIVERSAL PRECAUTIONS AND ASCEPTIC TECHNIQUES TO AVOID CONTAMINATION OF THE KIDNEY PRIOR TO OR DURING PERFUSION e BE AWARE THE DEVICE USED DISPOSABLES AND SOLUTIONS AND THE KIDNEY CAN CARRY PATHOGENS USE UNIVERSAL PRECAUTIONS TO PREVENT EXPOSURE TO THE USER CLEAN THE DEVICE AFTER EACH USE e USE PROPER PERFUSION PRESSURE AND DO NOT OVER PRESSURIZE AN ORGAN e DISPOSE OF CONTAMINATED CASSETTES AND SOLUTION USING UNIVERSAL PRECAUTIONS AND LOCAL PROTOCOLS TO PREVENT POTENTIAL EXPOSURE TO OTHERS Page 10 of 139 THE WAVES PERFUSION SYSTEM The WAVES perfusion system is a two part system consisting of a control unit and a single use disposable cassette which contains the kidney and machine preservation solution WAVES Control Unit Figure 1 The WAVES perfusion system front view Figure 2 The WAVES perfusion system back view Page 11 of 139 THE WAVES
6. STORE OUT OF DIRECT SUNLIGHT BA Symbol for Consult Instructions For Use WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT WEEE The Waste Electrical and Electronic Equipment Regulations 2006 No 3289 WEEE have been put in place to ensure that products are recycled using best available treatment recovery and recycling techniques to ensure human health and high environmental protection When you have finished with a WEEE product please do not put in your domestic waste bin as it will not be recycled To ensure that your WEEE is recycled in accordance with the regulations you should ensure that the goods are not put in the bin but are separately disposed of by taking the WEEE to your local designated collection facility This would normally be your local civic amenity site recycling center You can find your local approved site Page 139 of 139
7. CONTROL UNIT The WAVES control unit Figure 1 and 2 regulates the pulsatile perfusion sequence The WAVES will perfuse the organ with machine perfusate and monitor real time pressure flow and temperature of the perfusate Further the control unit will display all parameters for visual confirmation of perfusion activity The control unit will provide trend data to help the evaluation of the kidney prior to transplantation Data Storage The user can select data to view in the display and or download onto a USB flash drive The WAVES control unit has a USB port for data transfer and storage onto a flash drive on the back of the unit The user should determine if the flash drive is recognized by the unit prior to data transfer Figure 3 WAVES USB data storage Page 12 of 139 Network Connectivity The WAVES system permits the user to view the current perfusion data on a network or smartphone when the unit is properly connected to a network The user will need to work with local IT support to make certain the device can be accessed by the local network After connecting the WAVES system to a network using an Ethernet line the user can monitor the WAVES using a web browser THE USER CANNOT CONTROL the unit or make any adjustment over any network The WAVES web display will provide current perfusion parameters such as pressure temperature renal resistance value and alarms The total perfusion time can be monitored A perfusion rep
8. Check the cassette if both temperature and pressure sensor are missing e Stop pulse pump e No value of pressure The pressure value is replaced by in red USER Actions e Check cassette cable connection Change cassette Call WMS technical support if the problem persists WAVES Actions e Reset stroke to zero and try to reach again the set pressure e The value of systolic pressure is displayed in red USER Actions Check cassette tubing Check kidney Check cassette cable and sensors Call WMS technical support if the problem persists WAVES Actions e The value of systolic pressure is displayed in red USER Actions e Check cassette tubing e Check kidney e Check cassette cable and sensors WAVES Actions e The value of systolic pressure is displayed in red USER Actions e Check cassette tubing e Check kidney e Check cassette cable and systolic pressure too high systolic pressure too low unable to reach desired pressure Page 88 of 139 sensors e Check cassette e Check pulse pump e Call WMS technical support if the problem persists No cassette Cassette connector WAVES Actions temperature sensor temperature disconnected e Alert the user missing signal Broken wires on e No value of temperature Cassette missing detected cassette cables The temperature value is Check the cassette Broken wires on replaced by in red if both
9. Door latch WAVES doors WAVES display 3 cassette latches Figure 17 Description of the WAVES system Page 27 of 139 GETTING STARTED SET UP AND CONTROL PROCEDURES RECEPTION INSTALLATION 1 Remove the WAVES from the shipping box or transport bag using proper lifting techniques to avoid injuries 2 Check the presence of all parts and accessories A Battery doors B Ice compartment cap C AC power cord D Network cable prior to starting the device if you plan to network and monitor the unit Ethernet cable not provided 3 To determine that the WAVES is in proper condition check if the WAVES is in good shape A Make sure doors are not damaged hinges are functional and doors latch properly B Check device body for cracks or damage C Check external connectors by plug in and then unplugging the A C power cord an Ethernet line and the USB drive D Examine touchpad display to determine it is not damaged 4 Install the Waves unit in the designed lab on a flat surface counter or cart with access to data access and a power supply 5 Store the unit in the WAVES transport bag and in a secure area 6 In either circumstance make sure the following environmental factors are respected for optimal conditions A Temperature lt 23 C B Humidity 50 or less C AC electrical and network connections available D Setup area for accessories and disposable parts Page 28 of 139 E Ice and cold re
10. EE EE A E RE E EE E T 32 TRANSPORT BAG naoa a E E N T E EON OA OOE E ENA 33 WAVES SOFTWARE DEFINITION AND GENERAL DESCRIPTION OF CONTROLG 000 34 POWER ON OFF STAND BY CHARGING cccssscccccceesssssseeeceecsssssnseeeeeceesseessaeeeeceseseseaseeeeesesseeaaeeeeeessseesaaeeeeees 34 DI PAY USERINTER AC E eroaisi i E EE A vedumue eases bane enteadaaconanarteneansesea tens 34 SOFTWARE FABLE OF CONTEN T orcii E E E TEE OAE E O E te 35 AN AVE oe NE AG E sorsara a A E E E radon eaunpoien inches adel 86 ALARMS AND TROUBLESHOOTING siisssscsdicccecedsncasoncssscndscvdeasiossecenncencesneconesdansienceiesensacsvensse 88 WAVES SOFTWARE TECHNICAL MENU DEFINITIONS AND GENERAL DESCRIPTION 92 TECHNICAL VEN TABLE OF CONE INS jcc ciccedsinacies say nesir ni E E EES 92 PARAMETER MEASUREMENT RANGE siisescscccccscessccascssecsencnspesnconscciesencsusesedsceaecsesacenenuecedauss 130 MAINTENANCE ssri 131 PULSE POMP oa E E E A mauwinraauaper saad 131 CLEANING AND STERILIZATION OF TRANSONIC FLOWPROBEG ssssseeeeceeccceceeeeaaeeeeseeseeeeeeeeeeeeeeeeeaaaaaaassses 131 BATTERY pla oe CT TORA Eei EEE ee ee 131 POR AE ar r T tareaacin E E A E E E T E E 132 STUMP PILING seiigis a E E E A a EA A RASA 132 CLES MIN Gera E E A E E E E E es reiaaay anes 133 PRACTICE aa E A E E E E A E nen re reps 133 APPENDIX A SPECIFICATIONS sicscsatccccacssssaecssseneusssesecsnontanedecssscdssessenessssasaneacntawacesssenasseienens 134 APPEN
11. FROM STATE TO STATE Page 3 of 139 TABLE OF CONTENTS FIGURE INDEX siceccsacssssssinedacsesacwssietsvececnssanssnianusussiwesenedassaciesenedesswassacssllsasaceedesunssensnsesnsancenesaiss 5 INTRODUCTION cveccscassestsencssiesiccncacwscneinsedusanddieas onan E EEE E E E EE 6 CONTENTS INCLUDED scisasiessinncacnssansaacssvssnsentencnsestcateesssesanwsesedewsesswadnsncsesssensvaiesawswedexensneniesesseve 6 STATEMENT OF INTENDED USE a isscccasiscsdccesscsecacssescscadesaqcacasesincessvescccascenseadsessacdeaseenecenseaeccneeses 7 PRECAUTIONS sncaccsscsscsstenesacnenadeonctevadecdesanssotenvesiesiwssenessamadessbaapeseneeesasssessseeassumeactanscensateneoucss 8 WARNINGS sosrcssrrsessireipane aier opao Ean e EN E EN Ea S EEE ESE ENTENEN Eea 10 THE WAVES PERFUSION SYSTEM ssirrssreseisoreroronoressersoresoro srania sn aR An ORE Raai 11 TRENY AVE SCONE AAN a e A E A A A AA AA AEA AAE A E AAE 12 EAEN AVES CA SETTE VW GM ieran E E E 21 DESCRIPTION OFTHE WAVES SYSTE Niisirrroni r aran Nn N E AE E E O E OTEO E E E 27 GETTING STARTED SET UP AND CONTROL PROCEDURES s sssessessssssssssssssssssssossssossssosssssese 28 RECEPTION INSTALLATION seseaensnataenlns corecenaaninnnentcusenensceudeceescetecentasisuansstevecenvaut EEEREN EE EEI REEE ERNER SiiS 28 SE FUPINSTRUC HONS scasenanasocaoningalesin coat nEn NENA AE EATE ERATA E ERNA E EENG 30 END OFFER FUS IN rinna E EE A E A AT E E E 31 TRANSPORTATION sscscnspenaacinnsdensnapatuatsnageamaranetieestenamananenedanas
12. Firmware 5 Update Device Firmware Please connect USB This screen is displayed when no USB flash drive is detected on Technical Menu screen 35 Maintenance Update Device Firmware 2 Pressing OK goes back to Technical Menu screen 34 Maintenance Update Device Firmware 1 Page 129 of 139 PARAMETER MEASUREMENT RANGE Low Alarm Displayed a High Alarm limit Parameter Range limit factory Range factory default default Systolic Pressure mmHg 0 100 0 100 0 o m0 Flow ml min 0 250 0 250 o 200 0 9 99 0 999 0 O Perfusate Temperature 3 10 C 0 30 C 2 C Page 130 of 139 MAINTENANCE Please call WMS technical support for all questions or problems Do not try to open the WAVES technical zone covers or repair the WAVES Opening this cover will negate the manufacturer s warranty PULSE PUMP The pulse pump requires no periodic maintenance If failure occurs consult the WMS Customer Service see page 2 CLEANING AND STERILIZATION OF TRANSONIC FLOWPROBES The Transonic flowprobe installed in the cassette chamber of the WAVES control unit cannot be removed from the WAVES control unit If failure occurs consult the WMS Customer Service see page 2 BATTERY SHELF LIFE amp STORAGE e The WAVES system has four smart LI Ion batteries e Each battery s nominal operating voltage is 10 8V e The smart battery should be stored in a well ventilated environment with low humidity free
13. Menu screen 15 Technical Menu screen 16 Technical Menu screen 17 Technical Menu screen 18 Technical Menu screen 19 Technical Menu screen 20 Technical Menu screen 21 Technical Menu screen 22 Technical Menu screen 23 Technical Menu screen 24 Technical Menu screen 25 Technical Menu screen 26 Technical Menu screen 27 Technical Menu screen 28 Technical Menu screen 29 Technical Menu screen 30 Technical Menu screen 31 Technical Menu screen 32 Technical Menu screen 33 Technical Menu screen 34 Technical Menu screen 35 Technical Menu screen 36 Technical Menu screen 37 Secured connection Wrong password Menu Settings menu Settings Alarms settings 1 Settings Alarms settings 2 Settings Language Settings Owner Password 1 Settings Owner Password 2 Settings Owner Password 3 Settings Owner Password 4 Settings date and clock Settings Networking Settings Pressure Flow 1 Settings Pressure Flow 2 Settings Pressure Flow 3 Settings Pressure Flow 4 Settings Pressure Flow 5 Settings Pressure Flow 6 Settings Temperature Maintenance Menu Maintenance Battery Maintenance Sound Maintenance Screen 1 Maintenance Screen 2 Maintenance Screen 3 Maintenance Screen 4 Maintenance Sensors Maintenance Pumps Maintenance History Menu Maintenance History Alarms Maintenance Factory Default Maintenance Update Device Firmware 1 Maintenance Update Device Firmware 2 Mainten
14. PERFUSION PRESSURE Set perfusion pressure This screen is displayed when you push the OK button on the Clinical screen 14 place kidney Please set the desired systolic perfusion pressure the device will be expected to reach during the perfusion and press OK to go to the next step You can increase or decrease the systolic pressure at which the device will initially operate by using the up and down arrow Maintaining pressure on the arrows automatically changes the value of pressure By pushing the Back button you can go to the previous screen Clinical screen 14 place kidney Page 54 of 139 e CLINICAL SCREEN 16 PRESSURE CONTROL MODE Choose control mode Auto pressure control 2 0 Manual pressure control mmHg Back This screen is displayed when you push OK on the Clinical screen 15 set perfusion pressure Select the pressure control mode by pushing Auto pressure control or Manual pressure control A real time pressure is displayed on this screen Auto pressure control In AUTO control mode the set pressure is constantly maintained and regulated The compression on the bellows pumphead will be increased or decreased to maintain the pressure In this mode 2 minutes of constant pressure at 20 mmHg the initial pressure selected in the technical menu is respected Then the pressure will increase by 5 mmHg every 2 minutes as set in the technical menu until the desired perfusion pressure 1s reached set on the pr
15. UL94V 0 flammability rating 100 240VAC 50 60 Hz medical grade universal power supply 4 Li Ion batteries for transportability and battery backup Battery compartment easily accessible on the back Built in charger for batteries Both main line circuit breakers Blow wieasarenicut Transonic flowmeter board built into the WAVES Transonic flowprobe attached to the WAVES Pressure measurement Disposable medical pressure sensor on the cassette Power Perfusate disposable RTD sensor on the cassette Temperature measurement Ice water non disposable RTD sensor in the ice compartment Pressure display 1 0 mmHg Levels of Accuracy for Temperature display 0 5 C Functionality Flow display 7 Renal resistance display calculated Pressure 0 to 100 mmHg Temperature 0 to 40 C Flow 0 to 250 ml min Interfaces with systems Ethernet network connectivity Internal 2 MB non volatile memory Aa OTAS cubed das USB for memory device for data history transfer Size adond 25 2 x 16 x 13 YEDE 648 mm x 413 mm x 337 mm Weight WAVES System 26 kg fully loaded Lifetime of the product s Measured limits Flows pressures Temperature Page 135 of 139 APPENDIX B BLOCK DIAGRAM The Functional Diagram describes the operation of the WAVES monitor and the WAVES cassette Cassette Bubbletrap Kidney OrganChamber flow MOls Flowsensor fji flow Pumphead KG Heatexchang A Oxygenator
16. WAVES Control Unit in Open or General Perfusion or Transport Clinical configuration with cassette configuration open for organ placement Page 17 of 139 Air port The WAVES system allows oxygen to be diffused into the preservation solution and thus to the kidney using the oxygenator membrane in the cassette and an air pump installed in the WAVES control unit No user action is needed for this feature After the cassette is placed in its compartment the air circuit is automatically connected and the air pump is started An external air port is provided on the back of the device if connection to an external oxygen source is required The port adapter supplied should be screwed into place during use and removed following each use Figure 11 WAVES external air port Page 18 of 139 Temperature regulation The WAVES system has a coolant reservoir where the user can place up to 5 liters of ice and water The user should fill the ice water reservoir initially with a minimum of 2 to 1L cold refrigerated water The user should then completely fill the reservoir with and ice Small pellet ice cubes are preferred but ice in any form may be used The reservoir lid should be closed and remain closed during perfusion and transport Reservoir Lid Sample Vial Coolant Reservoir N Figure 12 Ice compartment A liquid level sensor in the ice reservoir will alert the user in case not enough water is added This ice compart
17. and reach the next step By pushing the Back button you can go to the previous screen Clinical screen 5 Activate coolant pump Page 45 of 139 e CLINICAL SCREEN 7 INSTALL CASSETTE Install the cassette Please connect the sensors cable and activate locking mechanism n OK detection prey This screen is displayed when you press the OK button on the Clinical screen 6 Check Cassette With gloved hands holding the side of the cassette but not touching the lid of the cassette install the cassette in its compartment connect the sensor cable and activate the 3 locking mechanisms Do not touch the top of the cassette lid during this process The device automatically detects the two sensors in the cassette pressure and temperature The device has to detect both the pressure and the temperature sensor to be able to go to the next step If one or several sensors are not detected the system stays at this step and the perfusion cannot be done In this case please check the connection of the cables or call WMS technical support Before the cassette is installed and the sensors detected a red box is displayed showing the device waiting for the sensor detection Installing the cassette properly and connecting the sensor cable makes the corresponding red box become yellow with an OK message displayed The WAVES control unit goes automatically to the next steps if the sensors are detected Pushing the Back button you can go
18. from corrosive gas at a recommended temperature range lt 21 C e Extended exposure to temperatures above 45 C could degrade battery performance and life Storage Temperature Limits 20 C to 60 C 80 RH Do not immerse the batteries in water Do not disassemble or deform the battery Do not expose to or dispose of the battery in fire Avoid excessive physical shock or vibration Never use a battery that appears to have suffered abuse Battery must be charged in appropriate charger only dedicated level II or level III smart battery charger Never use a modified or damaged charger The fuel gauge on the back of each battery determines the state of charge e Do not short the battery e Calibration is the process whereby the battery s fuel gauge is adjusted to maintain an acceptable level of accuracy This may be necessary if a battery has aged or has been subjected to an unusual usage pattern Please proceed to the calibration with an adequate charger or call WMS technical support e Regulations vary for different countries Dispose of battery in accordance with local regulations Page 131 of 139 STORAGE Drain the ice chamber completely See Cleaning section on page 133 Remove the cassette if any from the cassette chamber and dispose of properly Store the WAVES in a dry room temperature environment in the Waves transport bag for protection For long term storage remove batteries and drape the transport bag and un
19. on the Main Menu screen Prior to shut down Please remove the cassette connect the AC cable to charge the batteries and press and hold the Shutdown button for 5 seconds Maintaining the Shutdown button shows the Shutdown screen 2 Pushing Back button you can go to the previous step Main menu screen Page 82 of 139 o Shut down screen 2 Shut down Shutting down of the system z Shut down This screen is displayed when you maintain control of the Shutdown button on Shut down screen 1 Please press and hold the Shutdown button for 5 seconds to shut down the WAVES control unit A counter is displayed on the screen from 5 to 0 until the system is shut down If you stop pushing the Shutdown button the shutdown system is aborted and the system goes back to the Shutdown screen 1 Page 83 of 139 e ALERTS SCREEN Pert I1D 2156470 50 C lt Message gt DIJA 20 Flow 120 ml min OK Tra nsport i This screen is displayed when an error alert occurs Page 84 of 139 e ALARMS SCREEN Perf ID 2156470 a0 s 27 mmHg Sys too high DIA Flow OK ml min Res 0 22 Transport ag This screen is displayed when an alarm condition occurs See also Alarms and troubleshooting on page 88 Each time an alarm occurs a red message box appears to alert the user and describe the problem Depending of the parameters concerned by the alarms The name of the value and value concerned are disp
20. pressure using the touchpad screen see software and control description beginning on page 36 the volume of perfusate delivered by the pump to the kidney is increased or decreased along with a corresponding increase or decrease in pressure Page 16 of 139 WAVES configuration The WAVES system has two configurations closed and open Closed configuration Figure 9 For storage clinical organ perfusion or transport This configuration will be used during perfusion to increase heat exchange and reduce the loss of ice during perfusion The closed configuration also provides maximum protection for the kidney When not in perfusion mode or during storage the unit should be placed in the transport bag The bag is vented and can be used for short transport periods during perfusion but the unit should be removed from the bag immediately when the unit reaches its desired location or frequently during any extended perfusion transport period to prevent heat build up Open configuration Figure 10 To place kidney in the cassette and begin perfusion to visualize the kidney on the device or sample perfusate In general the organ should be perfused with the devices lids in the closed position This open clinical configuration gives the user space to work The two doors may be used as work spaces covered with the sterile drape during placement of the kidney Waves ES Figure 9 Figure 10 WAVES Control Unit in Closed
21. temperature WAVES cassette USER Actions and pressure sensor interface cable e Check cassette cable and are missing Internal controller sensors connector Call WMS technical support Failure of the sensor if the problem persists Pressure circuitry failure on controller Cassette Failure of the coolant WAVES Actions Cassette temperature temperature pump Alert the user too high Too High Blocked coolant Start coolant pump if ice gt 10 C tubing container temperature is Bad contact on heat lower than 10 C exchanger Temperature value Coolant temperature displayed in RED too high no ice USER Actions Check cassette cable and sensors Check cassette Change ice Call WMS technical support if the problem persists WAVES Acti Flow controller WAVES Actions failure e Replace the value of flow by No message Flowmeter lt _ lt in RED a s Onnection between USER Actions functioning owmeter an controller board e Stop the perfusion and call WMS technical support if the problem persists WAVES Actions Failure of the flow e Replace the value of flow by Flow sensor sensor in RED No message not Flow sensor USER Actions functioning disconnected Stop the perfusion and call WMS technical support if the problem persists Page 89 of 139 WAVES Actions Flow too high e Alert the user e Display the flow value in RED Maximum flow USER Actions Flow to high alarm settings e Check cassette
22. the transport bag is vented we recommend the user NOT TRANSPORT the WAVES in clinical perfusion mode for long periods while the device is in the transport bag without opening the zipped lid occasionally to limit heat buildup You can transport the WAVES on a car or plane seat In any case secure the WAVES with a restraining device 10 Keep the WAVES in an upright position to minimize the risk of bubbles or leaks 11 Control the state of the WAVES during transport if possible Page 32 of 139 TRANSPORT BAG The transport bag is an accessory item purchased separately and can provide a safe way to protect transport the device for short periods The bag has a zippered lid which can be zip locked for security and is equipped with wheels a pull strap and lifting handles The bag allows confidential donor information to be transported in a pouch on the inside of the zippered lid The information should be controlled at all times while in the transport bag Figure 18 WAVES transport ba Page 33 of 139 WAVES SOFTWARE DEFINITION AND GENERAL DESCRIPTION OF CONTROLS POWER ON OFF STAND BY CHARGING The POWER switch is located on the lower back left panel of the WAVES Pushing and holding the ON OFF switch permits one to turn ON the power of the WAVES and illuminate the display The device can be turned OFF using two methods By using the software and the touchpanel of the display see description for shutdown ope
23. to the Technical Menu screen 19 Settings Pressure flow 6 Pushing Back button goes back to the previous step Technical Menu screen 4 Settings menu Page 106 of 139 e Technical Menu screen 15 Settings Pressure Flow 2 Cooling process flow Set the flow the system operates during the 1500 250 300mL min Vv OK This screen is displayed when you press on Cooling Process button on the Technical Menu screen 14 Settings Pressure flow 1 Please set the stroke value corresponding to the flow value the system will operate during the cooling process and press OK to validate You can increase or decrease the stroke by pushing on the up or down arrow The system displays the value of the stroke target and the value of the associated estimate flow Stroke 0 to 200 flow 0 1 mL min Stroke 300 to 500 flow 0 10 mL min Stroke 600 to 800 flow 20 80 mL min Stroke 900 to 1100 flow 80 150mL min Stroke 1200 to 1400 flow 150 230 mL min Stroke 1500 to 1700 flow 250 300 mL min Stroke 1800 2000 flow 310 350 mL min Stroke gt 2000 flow 350 400mL min Pushing OK button validates this value and goes to the Technical Menu screen 14 Settings Pressure flow 1 Page 107 of 139 e Technical Menu screen 16 Settings Pressure Flow 3 Initial flow Set the initial flow the system operates during the kidney connection 80 150 mL min Vv OK This screen is displayed when you pre
24. tubing reached leaking Check kidney Check flow probe Call WMS technical support if the problem persists WAVES Actions Flow too low e Alert the user e Display the flow value in RED USER Actions e Check cassette tubing kinking e Check kidney Minimum flow alarms settings reached Flow too low e Check flow probe Call WMS technical support if the problem persists WAVES Actions No message e Alert the user Renal Renal resistance value e Display the RR value in red resistance higher than the maximum USER Actions too high limit e Check cassette tubing e Check kidney e Check cassette positioning Coolant pump trip WAVES Actions No message breaker e None ao Coolant pump current USER Actions Failur too high e If problems persist call Damaged coolant WMS technical support to pump change the coolant pump WAVES Actions No message e None ee a on a USER Actions Call WMS technical support to change the air pump Troubleshoot Battery 1 4 low Bad battery WAVES Actions Discharged Battery e Alert the user USER Actions Battery 1 4 low e Check batteries Page 90 of 139 Battery 1 4 missing Battery 1 4 not detected Turned on power but a REI no display Touchpad doesn t work No response when push on a button No ice left Temperature of the ice container higher than 15 C Coolant temperature too high Coolant fluid missing Not enough coo
25. 21 Maintenance Menu By pressing on the Back button you can go to the Main Menu screen Page 95 of 139 e Technical Menu screen 4 Settings menu Settings Menu oo Alarms settings Networking Tale Ur Te gt Press flow Owner password l Temperature Date and Time Back This screen is displayed when you press Settings button on the Technical Menu screen 3 Menu Alarms Settings button to go to the Technical menu screen 5 Settings Alarms settings 1 Languages button to go to the Technical menu screen 7 Settings Language Owner password button to go to the Technical menu screen 8 Settings Owner Password Date and Time button to go to the Technical menu screen 12 Settings date and clock Networking button to go to the Technical menu screen 13 Settings Networking Pressure flow button to go to the Technical menu screen 14 Settings Pressure flow 1 Temperature button to go to the Technical menu screen 20 Settings Temperature By pressing Back button you can go to the previous step Technical Menu screen 3 Menu Page 96 of 139 e Technical Menu screen 5 Settings Alarms settings 1 Alarm Settings Min Max _ Systolic o mmHg Flow o mL min A RR eae Vv Temperature C Back OK This screen is displayed when you press Alarms settings button on the Technical Menu screen 4 Settings menu You can change the maximum and minimum accepted values alarm values for e
26. AVES control unit display D Remove sterile WCM cassette specimen containers and sterile drape from box E Place the cassette in the WAVES prompted by the WAVES control unit display F Connect cassette cable to the WAVES control unit receptacle G Secure cassette latches H The WAVES will automatically prime the cassette I Allow the WAVES to reach appropriate perfusion temperature J Change to sterile gloves and remove the outer and inner cassette lids Place the sterile drape and lock in place Change into new sterile gloves and place the kidney in the cassette Attach the cannulated renal artery to the unclamped cassette arterial line The user can insert a WMS multi arterial adapter not supplied and additional clamps or cannula if needed for multiple renal arteries K Check for leaks while kidney platform is in up position L Verify that all parameters are within your stated protocol M Lower the platform Closed lids Label lids N Use the specimen containers included for storing associated materials biopsies fluids etc with the organ in the specimen containers and label properly Place Page 30 of 139 the containers up to four in the appropriate slots on the deck of the WAVES control unit see Figure 12 on page 19 O Close doors and monitor the organ P DO NOT LEAVE WAVES UNATTENDED FOR LONG PERIODS END OF PERFUSION A Discard medical wastes and disposable parts cassette perfusate disposable
27. Control unit 10 years after manufacturing release Disposable 2 years shelf life after sterilization Machine preservation solution for kidneys Clamps and Cannula for attaching kidneys Sterile drape and specimen containers Associated products Devices for network connectivity such as wireless routers USB memory devices for transporting preservation history data Wheeled Transport Bag ar Yes poe 24 hours operation on battery Temperature 0 to 40 Humidity 0 to 95 non condensing Pressure 94 to 101 kPa Elevation sea level to 2000 Temperature controlled 3 to 10 C Operation on ice 24 hours 10 max at 21 ambient with Hypothermic kidney operation an extra ice filling Power failure failsafe hypothermic preservation for 12 hours Pulsatile 60 pulses per minute fixed Pressure regulated or fixed Technologies Applied in End Function User Environmental Limits Perfusion 0 to 250 ml min perfusion flow ane Ambient air for oxygenation 1 5 2 L M oe External gas inlet port available local protocol approved f Low power LCD 4 3 color display Display User Interface LED backlight Page 134 of 139 po Integrated touch panel Ice and water circulated in a closed cooling circuit using thermal transfer to perfusate Ice water compartment capacity 5 Liters Cooling Easy ice entry access Easy drainage Coolant container sealed to prevent leakage Coolant pump 12 Volts DC non submersible
28. DIX B BLOCK DIAGRAM xssisceatesacesccsestsnacnviocecsessuasveassacesiesstuiisadessssccdessasssetsenesssceeedewacs 136 APPENDIX C FLOW MEASUREMENT scscssacescadscieswonensssncnasscsesntesssseiseiiessessxsevacdenadsevesesseeniesers 138 Page 4 of 139 APPENDIX WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT WEEE D GRAPHIC SYMBOL INDEX wicssnncsstscsncsatssennessusonnssatecontsenesosnsssinnsasevonsceiess FIGURE INDEX FIGURE 1 FIGURE 2 FIGURE 3 FIGURE 4 FIGURE 5 FIGURE 6 FIGURE 7 FIGURE 8 THE WAVES PERFUSION SYSTEM FRONT VIEW THE WAVES PERFUSION SYSTEM BACK VIEW WAVES USB DATA STORAGE WAVES NETWORK CONNECTIVITY WAVES BACK PANEL WAVES BACK PANEL CONNECTIONS WAVES BATTERY WAVES TOUCHPAD DISPLAY FIGURE 9 WAVES CONTROL UNIT IN CLOSED OR TRANSPORT CONFIGURATION FIGURE 10 FIGURE 11 FIGURE 12 FIGURE 13 FIGURE 14 FIGURE 15 FIGURE 16 FIGURE 17 FIGURE 18 FIGURE 19 FIGURE 20 FIGURE 21 WAVES CONTROL UNIT IN OPEN OR CLINICAL CONFIGURATION WAVES AIR PORT WAVES ICE COMPARTMENT WAVES WCM CASSETTE FEATURES WAVES WCM CASSETTE INSTALLATION WAVES CASSETTE LIDS WAVES ORGAN PLATFORM WAVES DESCRIPTION OF THE WAVES SYSTEM WAVES TRANSPORT BAG WAVES NETWORK CONNECTIONS WAVES BLOCK DIAGRAM WAVES FLOW SENSOR Page 5 of 139 11 11 12 13 14 14 15 16 17 17 18 19 21 22 23 24 27 33 87 136
29. INICAL SCREEN 1 USER NAME Enter user name User Name This screen is displayed when you press Clinical Perfusion button on the Main menu screen Please add the perfusionist name to the perfusion trend record using the keypad and press Enter to validate You can delete characters by pushing on the Del button to delete one character By pushing Back button you can reach the previous screen Main menu screen Page 38 of 139 e CLINICAL SCREEN 2 ENTER DONOR PERFUSION ID Enter Donor perfusion ID 364926 eee E ES RAN EEE0GOCEOCE BME Re Ee ae aaa Back space enter This screen is displayed after pressing Enter button on the keypad on the Clinical screen 1 User name Please add the Donor Perfusion ID to the trend record using the keypad and press Enter to validate and go to the next step You can delete characters by pushing on the Del button to delete one character By pushing Back button you can reach the previous screen Clinical screen 1 User name Page 39 of 139 e CLINICAL SCREEN 3A CONFIRM DONOR PERFUSION ID Confirm Donor perfusion ID 364926 ee ed Een Oe aE SANs pa txe i m njolelatr MRE Ee SEs Ese eas Back space enter This screen is displayed after pressing the Enter button on the keypad on the Clinical screen 2 Enter Donor Perfusion ID Please confirm the Donor Perfusion ID and press Enter button You can delete characters by pushing on the Del button to delete one charac
30. This application can be found on the USB drive provided with the WAVES Using Internet Explorer browser type the URL http xx xx xx xx MainFrame htm Replace xx xx xx xx with the IP address obtained in the previous step The WAVES webpage is displayed The word MainFrame htm is case sensitive You may need your IT Administrator to help you add a device to your network If allowed by your department manager you can use a wireless router and a simple network setup to wirelessly connect to a laptop or other wireless network capable device Figure 19 WAVES network connection Page 87 of 139 ALARMS AND TROUBLESHOOTING The following table gives a description of the alarms that can occur during the operation of the WAVES system and the associated troubleshooting No pressure e Cassette connector WAVES Actions pressure sensor signal disconnected detected e Internal controller connection Broken wires on cassette cables Broken wires on WAVES cassette interface cable Pressure circuitry failure on controller Kinked tubing Blocked arteries arterial lines or kidney Frozen kidney Failure of the pressure sensor Systolic pressure Too High Systolic pressure Too low Leak Failure of pressure sensor Cannot reach set systolic pressure Leaks in arterial line Leaks in bubble trap Leaks of the arteries Failure of the pressure sensor Failure of the pulse pump missing Cassette missing
31. Transport Display Auto pressure mode Pulse pump On touchpad locked no alarms AC Main connected This screen is displayed after all the preliminary steps are completed and is the main perfusion screen Different information and control are displayed Perfusion ID EXAMPLE 2156470 Perfusion ID entered at the beginning of the perfusion steps 5 C Temperature of the perfusate Pulse pump ON or Pulse pump OFF State of the pulse pump You can turn On or OFF the pulse and the air pump by pushing on this control This allows additional work to be performed in the cassette without perfusion continuing Auto pressure or_Manual pressure activated pressure regulation mode Auto or Manual You can display the pressure regulation mode message box to change the mode by pushing on this control Options to have access to the Options Menu Page 61 of 139 SYS value permit to see the actual systolic value in mmHg and change this value by pushing on the button Press on the control permit to have access to the pressure setting message box value mmHg display of the Mean pressure value Mean pressure is calculated using the formula Sys 2Dia 3 DIA value display of the diastolic value Flow value mL min display of the perfusate flow Res value display of the renal resistance value Renal resistance is calculated by mean pressure mmHg flow ml min On the bottom of the screen different control
32. WAVES control unit display to place the organ lift the cassette platform to the up position During organ placement the platform should remain in the up position The kidney can then be placed on the cassette platform for cannulation This position allows the perfusionist direct access to the arterial port and the organ s artery s Either the attached silicone tube or multiple artery adaptor not supplied is used to attach the organ via its perfusion clamp or cannula to the port for perfusion Note If the silicone tubing seems too long it is easily shortened as necessary using scissors After venting air from the clamp cannula and renal artery s the kidney is attached to the port The pressure must be monitored and should remain Page 24 of 139 low at this point After checking for leaks the kidney can then be secured with the retaining net on the organ platform The platform is then placed in the lower position To summarize the platform is removable and has two positions The Up or benching position permits the user to have easy access to the kidney particularly during placement for perfusion The Down or perfusion position must be used during the perfusion The two lids can be closed only in this position BUBBLE TRAP AND SAMPLE PORT The cassette is fitted with a bubble trap that separates trapped air bubbles from the perfusate prior to the arterial This helps prevent bubbles from embolizing the kidney The cassette integr
33. ach following parameters Systolic pressure Systolic Flow Flow Renal Resistance RR Perfusate Temperature Temperature Select the parameter by pressing the value you want to change then use the arrows decrease or increase the value Press OK button to validate and go back to the Technical menu screen 6 Settings Alarms settings 2 Press Back button you can go to previous step Technical Menu screen 4 Settings menu Page 97 of 139 e Technical Menu screen 6 Settings Alarms settings 2 Confirm the new alarms settings Yes This screen is displayed when you press on OK button on the Technical Menu screen 5 Settings Alarms settings 1 You have to confirm and cancel the modifications you made on the alarms settings Please press NO button to cancel the changes and go back to the Technical menu screen 5 Settings Alarms settings 1 Please press YES button to confirm your changes and go to the Technical menu screen 4 Settings menu and saves the modifications Page 98 of 139 e Technical Menu screen 7 Settings Language Language English miclaleciis Espanol OK This screen is displayed when you press Languages button on the Technical Menu screen 4 Settings menu On this screen you can change the language used in the device English French or Spanish Insert the USB flash memory with the languages into the USB port and then select the language by pushing on the corresponding button Engl
34. actory Default Pushing Update Firmware goes to technical menu screen 34 Maintenance Update Device Firmware 1 Pushing Back button goes back to Technical Menu screen 3 Menu Page 113 of 139 e Technical Menu screen 22 Maintenance Battery Maintenance Battery Total 95 14 hours B1 100 4 6 hours B2 100 4 6 hours B3 90 3 5 hours B4 90 3 5 hours This screen is displayed when you press Battery button on the Technical Menu screen 21 Maintenance Menu You can check each battery s charge percentage and remaining hours Pushing OK button goes to Technical Menu screen 21 Maintenance Menu Page 114 of 139 e Technical Menu screen 23 Maintenance Sound Maintenance Sound Push on the speaker to check it This screen is displayed when you press Sound button on the Technical Menu screen 21 Maintenance Menu You can check the speaker of the device used for the alarms and the system Please press the 4 Pushing OK button goes to Technical Menu screen 21 Maintenance Menu speaker symbol to activate the speaker Page 115 of 139 e Technical Menu screen 24 Maintenance Screen 1 Maintenance check the screen dE S Second Black screen with backlight Black screen without backlight White screen This screen is displayed when you press Screen button on the Technical Menu screen 21 Maintenance Menu You can check the screen of the device by pushing each of the buttons Th
35. ae O SYS 40 5 0 C 27 mmHg Confirm to end the DIA 20 perfusion Flow 120 ml min No res 0 22 haco Tra nsport T pertusion This message box is displayed if you push the STOP PERFUSION button on the Main perfusion screen This button is active and displayed on the screen only if the pulse pump is turned off Please press YES to confirm your choice and end the perfusion Be careful this action is definitive The perfusion data will be closed and saved in the history and the perfusion ended Please press NO to cancel your choice and keep the perfusion active Page 66 of 139 e CLINICAL SCREEN 21 CHANGE PERFUSION PRESSURE MESSAGE BOX Perf ID 2156470 O SYS 40 5 0 C 27 mmHg Set perfusion pressure j i DIA 20 4O E ml min K 0 22 RES Transport T This message box is displayed when you push on the SYS button during a perfusion Please change the systolic perfusion pressure you want the system to perform Using the A up or V down arrow you can increase or decrease the set pressure value Press OK button to confirm your choice In the Manual pressure regulation mode the pressure is instantaneously reached In the Auto pressure regulation mode the pressure is increased or decreased gradually SmmHg every 2 minutes set in technical menu by default until the set pressure is reached Page 67 of 139 e CLINICAL SCREEN 22 BATTERIES STATUS MESSAGE BOX Perf ID 2156470
36. aint CAUTION Never use the following for cleaning the WAVES or permanent damage may occur to the finish or cabinet e DONOT USE gt 10 chlorine bleach and water solution e Solvents such as methyl or ethyl alcohols acetone trichloroethane trichloroethylene Freon or denatured ethanol After each use the coolant tank should be drained and a disinfectant used to rinse out the container The coolant tank should be stored dry PRACTICE Practice setup and perfusion techniques using human research organs with proper paperwork and permission or use animal kidneys with appropriate paperwork and permission to become familiar with the kidney perfusion using the WAVES system Use aseptic techniques to avoid any contamination Place the kidney and the arteries in adequate position to avoid any kink or damage Cannulate properly to avoid any leaks Select adequate perfusion pressure to avoid damage of the kidney NEVER leave the device unattended Page 133 of 139 APPENDIX A SPECIFICATIONS Product Definition Specification FDA Class II Medical Device Device classification CE Class HA Electric Class I Pulsatile Perfusion Oxygenator Hypothermic Control Micro Processor Control and data acquisition Network monitoring Organ Procurement Organizations OPO hospitals Used by OPOs hospitals and in other clinical environments Operators should be specially trained in organ preservation Product Life
37. al e Always inspect the unit power cord WCM perfusion circuit and all accessory cables for damaged connectors or wires prior to use The use of any damaged accessories or cable may cause a loss of signal or interference Use only manufacturer approved accessories e tis recommended users transport the WAVES using only the WAVES transport bag e The user must remove the WAVES control unit from the WAVES transport bag for clinical use e Prior to clinical use one should position the WAVES control unit on a flat and level surface at a height which provides an easy view of the display The user should provide adequate space to open the unit s doors Easy access to the power switch network cable USB port and other accessories 1s recommended e Cold water and ice are necessary for unit operation e Do not block the vent holes on the left side of the unit the front portion of the unit or under the device cabinet e Do not autoclave or sterilize the WAVES Clean the WAVES using non corrosive non acidic antiseptic cleansers which are safe for plastics and painted surfaces e Check ice and battery levels regularly Completely charge the batteries and refill the ice reservoir prior to transport e Use only ice and water in the reservoir for cooling purposes e Keep the device upright at all times e Do not expose the unit to direct sunlight and extreme temperature hot or cold e Beware any moving mechanical part such as the doo
38. ance Update Device Firmware 3 Maintenance Update Device Firmware 4 Maintenance Update Device Firmware 5 116 117 118 119 120 121 122 123 124 125 126 127 128 129 Page 92 of 139 e Technical Menu screen 1 Secured connection Enter password 36fd4af ee eee This screen is displayed when you push the Technical Menu button on the Main Menu screen Software specifications The entire Technical Menu is protected by password Only administrator may access the technical menu If you lose your password please call WMS technical support to reset Please enter your password using the keypad and press Enter to validate and have access to the Technical Menu screen if password is correct By pushing Back you can go the previous step Main Menu screen Page 93 of 139 e Technical Menu screen 2 Wrong password Enter password 36fd4gf Wrong password Please enter correct password If the password is not correct this message box appears to alert you Please press OK to be able to enter the password again Page 94 of 139 e Technical Menu screen 3 Menu Technical Menu settings Maintenance This screen is displayed when the correct password is entered Please choose the section you want to access by Pressing Settings button to go to the Settings Menu Technical menu screen 4 Settings Menu Pressing Maintenance button to go to the Maintenance Menu Technical menu screen
39. ates a disposable perfusate temperature sensor and a disposable pressure transducer in the bubble trap for ease of use The cassette provides an auto fill capacity and level control mechanisms to regulate fluid height in the trap WMS recommends the user verify the cassette is in proper working condition aseptically wrapped and shipped a needleless sample port is located on the upper portion of the bubble trap The sample port allows the operator to either infuse drugs into the perfusate or withdraw perfusion samples for analysis The perfusate level should remain constant at all times for accurate pressure measurements PERFUSION PUMPING The pumping system is made up of a pulse pump piston in the WAVES control unit and a bellows pumphead in the cassette which provides true pulsatile flow The pump head includes two one way valves in series and a silicone bellows pumphead which is compressed and decompressed by the pulse pump piston The bellows pumphead is self aligned in the pump assembly The WAVES control unit has variable systolic pressure control allowing the operator to adjust the pulse compression of the pulsatile pump piston on the cassette bellows pump head By accessing the systolic pressure control buttons on the display the user can Increase the pump compression the volume of perfusate from the pump head to the kidney is increased along with a corresponding increase in pressure Decrease the pump compression the volume o
40. ber Pushing the Chart button you can see the data in a graphic format see Perfusion History screen data chart Pushing the Transfer button you can transfer the data using a USB flash drive in comma separate value CSV format The USB flash drive is automatically detected by the WAVES control unit Pushing the Back you can go to the previous step Page 74 of 139 o Perfusion History screen data chart Press aan Sino Press RR 100 250 80 200 60 P 40 20 1 Back Press Flow Temp J Pre RR This screen appears when you push on the Chart button on the previous step Perfusion History screen data table On this screen you can have access to 4 different Trends Pressure trends Systolic and diastolic Flow trend Rena r sistance trend Perfusate temperature trend You can switch between the different Trends by pushing on the corresponding button Press Flow RR Temp The Control button of the activated trend is displayed in white The other trend choices are in blue Pushing the Back you can go to the previous step Page 75 of 139 o Perfusion History screen data transfer Transfer Data transferring Please wait This screen is displayed if you push on the Transfer button on the History screen data chart or the History screen data table if a USB flash drive is connected During the transfer a message Data transferring Please wait and the M
41. by the operator Renal resistance is calculated by dividing the mean pressure in mmHg by the flow in ml min and also displayed continuously Mean pressure is calculated using the formula Mean Sys 2 x Dia 3 Where Sys systolic pressure and Dia diastolic pressure in mmHg WAVES components accessory products and disposable supplies are intended to be used for pulsatile perfusion of the kidney These products are to be used in accordance with this instruction manual associated WMS documents and accepted medical standards Only accessories and supplies purchased from or recommended by WMS are to be used with the WAVES In addition only preservation solutions designed specifically for pulsatile perfusion of the kidney should be used with the WAVES Use of supplies other than WMS may result in less than optimal performance and may invalidate the warranty 1 Immediate Function and Cost Comparison Between Static and Pulsatile Preservation in Kidney Recipients J A Light F Gage A E Kowalski T M Sasaki C O Callendar Clinical Transplantation 1996 10 233 236 2 Efficacy of Clinical Cadaver Kidney Preservation by Continuous Perfusion R M Hoffman R J Stratta H W Solinger M WarningsKalayoglu J D Pirsch F O Belzer Transplant Proceedings Vol XX No 5 October 1988 pp 882 884 Page 7 of 139 PRECAUTIONS e The WAVES control unit should be operated by trained personnel who have read the instruction manu
42. cannula per local protocol using precautions to avoid any contamination B Drain and wipe out the ice reservoir Do not store the unit with water or ice in the reservoir C Download data to USB drive D Turn OFF the WAVES control unit E Connect to AC power to recharge batteries F Clean the WAVES control unit for next use See Cleaning instructions on page 133 Page 31 of 139 TRANSPORTATION During perfusion the WAVES system can be transported as needed The WAVES is made to secure the kidney during transport WMS provides a transport bag to make easier the transport of the WAVES WMS DOES NOT RECOMMEND shipping or transporting the device without a trained person to accompany the unit Users should respect the following guidelines to avoid problems during transport 1 2 3 4 5 6 7 Ne 8 8 9 Secure the kidney using the net enclosure on the organ support platform Install close the two cassette lids and lock the outer lid Attach an approved UNOS label to the cassette per UNOS guidelines Close the WAVES doors be sure the latches are locked Check the batteries are in place and note they are fully charged Add ice to completely fill the ice compartment Place the labeled typing material containers in the proper place on the device deck Place other accessories and donor documents in the transport bag in appropriate slots Use proper lifting techniques to place the WAVES in the transport bag While
43. coolant circulation if the temperature of the water in the ice compartment reaches 10 C Page 20 of 139 THE WAVES CASSETTE WCM The WCM cassette supplied separately is for single use and provides a sterile non pyrogenic fluid pathway The WCM cassette is a gravity flow system which houses and protects the kidney during perfusion and allows perfusate to be circulated through the kidney during perfusion The organ s position is controlled on the organ platform and is cradled by a mesh fabric during perfusion The organ is immersed in the perfusate during perfusion After the organ is perfused through the arterial port the effluent flow from the kidney is collected in the organ chamber The perfusate then flows through the membrane oxygenator and into the heat exchanger From here the solution is pumped to the bubble trap where it is delivered back through the arterial port to the cannulated kidney The perfusate then returns to the organ chamber to repeat the perfusion cycle Sensor Sampling drean Tray Connection ogi Integrated Temp amp Pressure Sensors iz Organ Chamber Bubble Trap with Auto Fill Oxygenator Heat Exchanger Pumphead Figure 13 WAVES WCM cassette features Page 21 of 139 CASSETTE PLACEMENT Inspect the cassette prior to use for any damages which may have resulted from shipping or handling From the label on the packaging the user should note the lot number and expiration date o
44. dd perfusate to cassette Please turn the pulse pump ON by pressing the OK button When you push OK the WAVES control unit engages the pulse pump piston to its zero position and the pulsatile pumping begins to prime the cassette and cool the perfusate The degree of compression on the below pumphead is set by default Pushing OK automatically activates the air pump The air pump is activated and deactivated every time the pulse pump is activated or deactivated By pushing the Back button you can go to the previous screen Clinical screen 9 Add perfusate to cassette Page 49 of 139 e CLINICAL SCREEN 11 WAIT FOR TEMPERATURE Wait for 5 C temperature 6 5 C This screen is displayed when you press the OK button on the Clinical screen 10 Turn On pulsatile pump The current temperature of the perfusate is displayed until it reaches the set perfusion temperature selected by software and adjusted in the technical menu At the same time the cassette priming is done The system operates at a high flow rate to accelerate heat exchange When the desired temperature is reached the device automatically goes to the next step Clinical screen 12 perfusion temperature at preset value By pushing the Back button you can go to the previous screen Clinical screen 10 Turn On pulsatile pump and stop both the pulse pump and air pump Page 50 of 139 e CLINICAL SCREEN 12 TEMPERATURE AT PRESET VALUE Perfusion tempera
45. displayed if no USB flash drive is detected when you launch a data transfer or the flash drive is not recognized by the WAVES control unit Please push the OK button connect a USB flash drive and launch the transfer again Page 79 of 139 e COOLANT DRAIN SCREEN o Coolant drain screen 1 Coolant drain Please place the drain tube into a container and keep pushing DRAIN S drain This screen is displayed when you push the Drain button on the Main Menu screen Please place the drain tube outlet in a container and press and hold the Drain button If you stop pushing the Drain button the draining stops instantaneously A level sensor in the ice compartment detects the minimal level of water and automatically stops the draining When the draining is completed the system goes to the Coolant Drain screen 2 Pushing the Back button you can go to the previous step Main Menu screen Page 80 of 139 o Coolant drain screen 2 Coolant drain Cooling compartment draining complete This screen is displayed when the ice water reservoir is drained completely Please push OK button to validate the action and go to the Main Menu screen Page 81 of 139 e SHUT DOWN SCREEN o Shut down screen 1 Shut down Please discard used cassette and plug the AC cable to charge batteries Maintain the button during 5 seconds to shut down the system Shut down This screen is displayed when you push the Shutdown button
46. e during the kidney connection You can increase or decrease the pressure by pushing on the up or down arrow and push OK button to validate and go to the Technical Menu screen 14 Settings Pressure Flow 1 Page 109 of 139 e Technical Menu screen 18 Settings Pressure Flow 5 Perfusion Pressure Set the default value for perfusion pressure LO rents This screen is displayed when you press Perfusion Pressure button on the Technical Menu screen 14 Settings Pressure Flow 1 Please set the default value of the perfusion pressure which is displayed on Clinical screen 15 set perfusion pressure Software specifications You can increase or decrease the pressure by pushing on the up or down arrow and push OK to validate and goes to the Technical Menu screen 14 Settings Pressure Flow 1 Page 110 of 139 e Technical Menu screen 19 Settings Pressure Flow 6 Auto pressure increase Set the pressure increasing increment and time to reach the set perfusion pressure in auto mode A OK This screen is displayed when you press Auto Press button on the Technical Menu screen 14 Settings Pressure Flow 1 Please set the rate in mmHg min of increase in pressure when the system is in Auto Pressure Control Mode using the down and up arrows and press OK to validate and goes to the Technical Menu screen 14 Settings Pressure Flow 1 In Auto Mode the system uses this rate to increase the pressure each time you change the
47. e following screens permit you to detect any damage on the display Pushing the Black screen with backlight button goes to the Technical Menu screen 25 Maintenance Screen 2 Pushing the Black screen without backlight button goes to the Technical Menu screen 26 Maintenance Screen 3 Pushing the White screen button goes to the Technical Menu screen 27 Maintenance Screen 4 Pushing Back button goes to Technical Menu screen 21 Maintenance Menu Page 116 of 139 e Technical Menu screen 25 Maintenance Screen 2 This screen is displayed when you press Black screen with backlight button on the Technical Menu screen 26 Maintenance Screen 1 You can check any failure of the screen on the device on a black background with backlight The display keep this screen during 5 seconds and goes automatically to Technical Menu screen 26 Maintenance Screen 1 Page 117 of 139 e Technical Menu screen 26 Maintenance Screen 3 This screen is displayed when you press Black screen without backlight button on the Technical Menu screen 26 Maintenance Screen 1 You can check any failure of the screen on the device on a black background without backlight The display keep this screen during 5 seconds and goes automatically to Technical Menu screen 26 Maintenance Screen 1 Page 118 of 139 e Technical Menu screen 27 Maintenance Screen 4 This screen is displayed when you press White Screen button on the Technical M
48. enu screen 26 Maintenance Screen 1 You can check any failure of the screen on the device on a white background The display keep this screen during 5 seconds and goes automatically to Technical Menu screen 26 Maintenance Screen 1 Page 119 of 139 e Technical Menu screen 28 Maintenance Sensors Maintenance Sensors 091010 n a 1500 Se 6O Mu H6XLF102BPBD Flow mL min 98 100 T cass To Level T Ice C Back Pulse pump ON This screen is displayed when you press Sensors button on the Technical Menu screen 21 Maintenance Menu You can check the good state and calibration of the pressure sensor flowsensor Flow the cassette temperature sensor Temp1 the ice container temperature sensor Temp2 and the ice container liquid level sensor Level Please select the stroke value of the pulse pump with the LUP and V DOWN arrows You can read the value of pressure flow cassette temperature and ice container temperature You can turn the pulse pump on or off by pressing the Pulse pump ON or Pulse pump Off button You need to place and lock a cassette to begin obtaining measures of flow and temperatures pulse pump On If the sensors are not detected cassette not in place only a white box with a horizontal dash is displayed Pressing Back goes to Technical Menu screen 21 Maintenance Menu Page 120 of 139 e Technical Menu screen 29 Maintenance Pumps Maintenance status current Pulsatile pum
49. evious screen Manual pressure control In MANUAL control mode you can increase or decrease the systolic pressure as desired The pressure is not auto regulated In this mode the user will choose the time to reach the perfusion pressure The time to reach the manually selected pressure is only applied the first time the system has to reach the set pressure selected at Clinical screen 15 set perfusion pressure After that if the user changes the set pressure the pressure will be reached instantaneously Pushing Auto pressure control button goes to the Clinical screen 17a Confirm auto pressure control mode Pushing Manual pressure control button goes to the Clinical screen 17b Confirm Manual pressure control mode By pushing the Back button you can go to the previous screen Clinical screen 15 set perfusion pressure Page 55 of 139 e CLINICAL SCREEN 17A CONFIRM AUTO PRESSURE CONTROL MODE Confirm auto pressure control mode Auto mode must be reactivated every 6 This screen is displayed when you push the Auto pressure control button on the Clinical screen 16 Pressure control mode Please press YES to confirm your choice or NO to cancel it and go back to the previous step Clinical screen 16 Pressure control mode The Auto Pressure Mode is only activated for a maximum of 6 hours and then must be reactivated to protect the kidney After 6 hours the manual mode is activated If the user wants to stay in auto mode
50. f perfusate from the pump head to the kidney is decreased along with a corresponding decrease in pressure The flow from the kidney is collected in the oxygenator membrane During the perfusion the perfusate is pumped from the oxygenator membrane passing through the heat exchanger to the pumphead then to the bubble trap The flow rate is measured by a flowsensor integrated into the device The temperature of the perfusate is regulated using the heat exchanger and a coolant pump The WAVES system has two parallel liquid circuits Perfusate circuit in the cassette during the perfusion the perfusate passes through a heat exchanger plate Page 25 of 139 Cooling circuit in the WAVES control unit Cold water near 0 1 C is pumped from the ice container and circulates through a heat exchanger base The heat exchanger plate and the heat exchanger base are in contact This contact allows the heat exchanger to cool the perfusate to the desired perfusion temperature The liquids of the two circuits perfusate and cold water are never in contact The ice water bath will maintain the hypothermic perfusate temperature for approximately 12 hours at below 10 C at an ambient temperature around 21 C After that time if needed the coolant will need to be drained and the ice replaced Page 26 of 139 DESCRIPTION OF THE WAVES SYSTEM 4 Sample vials i WCM Cassette Ice cap and f Cassette compartment O WU _ Compartment
51. frigerated water easily available F Cleaning materials easily available G Setup the device close to the area where the preservation solution is stored 7 Contact WMS technical support for any problems Page 29 of 139 SET UP INSTRUCTIONS 1 2 3 4 5 6 7 Use proper lifting techniques to avoid injuries each time you move the WAVES Use the transport bag when moving the unit Check the cleanliness of the WAVES control unit and insure the ice compartment is clean and empty before beginning a perfusion See page 133 for cleaning recommendations Make sure no cassette is installed in the WAVES unit Connect the power cord and network Ethernet line if needed before turning on the device Verify the batteries are in place Start the WAVES control unit by pushing on the power switch on the back left corner of the device The power switch lights up blue and the display starts When the unit is fully powered the user can launch a clinical perfusion session access history files drain the ice compartment check the battery status or access the technical menu After the user makes a choice the WAVES control unit directs the operator by prompts After pressing Clinical Perfusion the user will follow prompts to insure proper setup A Enter Username and Perfusion ID using the alphanumeric keyboard on the display user interface B Use aseptic technique C Fill the ice water compartment as prompted by the W
52. ge password button on the Technical Menu screen 8 Settings Owner password 1 You can change and confirm your password password needed to access to the technical menu Please enter the new password and press Enter then confirm this new password by entering it a second time and press Enter to validate and go to the Technical Menu screen 8 Settings Owner password 1 if the 2 passwords match We recommend writing this new password down Pressing the Back button you can go to the previous step Technical Menu screen 8 Settings Owner password 1 Page 102 of 139 e Technical Menu screen 11 Settings Owner Password 4 Enter actual password 514624 123456 Enter new password Confirm 4 Passwords don t ma match Please try again Sin OK 1 ee _ x Le 38 This screen is displayed when you press Enter button if the 2 new passwords don t match on the Technical Menu screen 10 Settings Owner password 3 Please press OK to enter the passwords again Technical Menu screen 8 Settings Owner password 3 Page 103 of 139 e Technical Menu screen 12 Settings date and clock Date and Clock DELMA 24 WA 03 JA 2009 dd mm yyyy Time hh mm _ OK This screen is displayed when you press Date and Time button on the Technical Menu screen 4 Settings menu You can change the Date and the Time Select the value to change by pressing on the value to change and then the arrows to increase or decrease
53. he WAVES control unit goes to the next steps and begins to regulate the pressure at the set perfusion pressure value At this point the perfusionist should check for leaks and if none are found then apply the webbed membrane over the kidney to control limit kidney movement on the platform The platform should be lowered into the solution The drape should be removed and the lids aseptically placed on the cassette and locked Finally the cassette should be labeled as described in your protocol Page 59 of 139 CLINICAL SCREEN 19 MAIN PERFUSION WINDOW Perf ID 2156470 5 0 C t f 0 ail Pulse Pump On f 4 h Auto Pressure flow 120 ml min Options RES Transport Auto pressure mode Pulse pump ON touchpad unlock no alarms ETAZ 5 0 C ss A0 Stee or 27 mmHg Pulse Pump On DIA 910 a a Sa Manual Pressure Fow 120 ml min RES 0 22 Options Transport Perf ID 2156470 50 C Auto Pressure row 120 ml min RES pension Transport Auto pressure mode Pulse pump Off touchpad unlock no alarms AC Main connected Page 60 of 139 Perf ID 2156470 50 C sys 40 2 mmHg wa 20 Manual Pressure i FLOW 120 ml min RES 0 22 i Transport a pertusion Options Manual pressure mode Pulse pump Off touchpad unlock no alarms AC Main connected Perf ID 2156470 5 0 C sys 40 27 mmHg DIA 20 Lock Active row 120 ml min RES 0 22 Tra nsport T
54. he has to reactivate the auto mode Page 56 of 139 e CLINICAL SCREEN 17B CONFIRM MANUAL PRESSURE CONTROL MODE Confirm manual pressure control mode This screen is displayed when you push the manual pressure control button on the Clinical screen 16 Pressure control mode Please press YES to confirm your choice or NO to cancel it and go back to the previous step Clinical screen 16 Pressure control mode Page 57 of 139 e CLINICAL SCREEN 17C TIME TO REACH PERFUSION PRESSURE Set time to reach perfusion pressure This screen is displayed when you push the Yes button on the Clinical screen 17b Confirm Manual pressure control mode Please set the desired time you want the system to take to reach the perfusion pressure set on Clinical screen 15 set perfusion pressure by pressing the UP or Down arrow This control mechanism is only used for the first increase of pressure at the beginning of the perfusion Then please press the OK button to validate your setting and goes to the next step Clinical screen 18 starting perfusion Page 58 of 139 e CLINICAL SCREEN 18 STARTING PERFUSION Starting perfusion This screen is displayed when you push either The Yes button on the Clinical screen 17a Confirm Auto pressure control mode The OK button on Clinical screen 17c Time to reach perfusion This screen is only displayed for 5 seconds to inform you that perfusion will begin After 5 seconds t
55. i transfer progress bar is displayed to inform the user The user will transfer all the data for the perfusion systolic diastolic temp RR perfusion number and date of the beginning of perfusion Pushing on the Back button you can cancel the transfer and go to the previous step Page 76 of 139 o Perfusion History screen data transfer completed Transfer Data transfer completed This screen is displayed if the transfer of the perfusion data to the USB flash drive is successful Please push the OK button to validate the transfer and go back to the Main Perfusion screen or to the Main Menu depending if a perfusion is launched or not You can now disconnect the USB flash drive To insure proper data transfer we recommend using a USB flash drive provided as accessory by WMS Page 77 of 139 o Perfusion History screen data transfer failed Transfer Connection failed Data transfer stopped This screen is displayed if the transfer failed disconnection of the USB flash drive or failure during the transfer The transfer is stopped Please push the OK button to validate and try again the transfer if needed Pushing OK made the system go back to the Perfusion History screen data table or Perfusion History screen data chart depending of the previous state of the system Page 78 of 139 o Perfusion History screen data transfer USB connection ok Back Transfer Chart ey This screen is
56. ironment see figure 15 During the organ placement process the user should place the internal lid on the cassette to seal the perfusate in the organ chamber and then twist and lock the external lid in place The two lids have a filter to equalize the internal pressure of the cassette with the environment particularly in cases of dramatic change of pressure The WCM cassette has been designed to allow for an organ identification label to be attached which should meet federal local transplant guidelines The double barrier WCM cassette meets current federal transplant contractor guidelines For more information See UNOS 5 0 policy for verification of organ packaging Page 23 of 139 Retaining Net Organ Platform UP Benching Position Organ Platform DOWN Perfusion Position Figure 16 WAVES organ platform ORGAN PLACEMENT The user should wear glasses surgical cap mask gown and STERILE gloves when touching the mounted cassette or its external lid Following the perfusion instructions on the WAVES control display when prompted to place the sterile drape the user must use aseptic technique The user should remove the outer and inner cassette lids and place them on a clean aseptic surface for later use Using aseptic technique the sterile drape should then be placed on the cassette and locked in place With the aseptic drape locked in place the user should change STERILE gloves and when prompted by the
57. ish Francais Espanol and validate by pressing OK button By pressing the Back button you can go to the previous step Technical Menu screen 4 Settings menu Page 99 of 139 e Technical Menu screen 8 Settings Owner Password 1 Owner password owner name password This screen is displayed when you press Owner password on the Technical Menu screen 4 Settings Menu Choose to change the owner name or the password Pushing Owner name button goes to the Technical Menu screen 9 Settings Owner password 2 Pushing Password button goes to the Technical Menu screen 10 Settings Owner password 3 Pushing Back button goes to Technical Menu screen 4 Settings Menu Page 100 of 139 e Technical Menu screen 9 Settings Owner Password 2 Change owner name This screen is displayed when you press Owner name button on the Technical Menu screen 8 Settings Owner password 1 The actual owner name is displayed You can change the owner name using the keypad and press Enter to validate Pressing Enter validates the new owner name and goes to the screen Technical Menu screen 8 Settings Owner password 1 Pressing Back you can go to the previous step Technical Menu screen 8 Settings Owner password 1 without validating the new owner name Page 101 of 139 e Technical Menu screen 10 Settings Owner Password 3 Enter new password 914624 Confirm new password 514624 j This screen is displayed you press Chan
58. it with a plastic sheet SHIPPING To return the WAVES control unit for maintenance periodic or corrective use adequate packaging materials provided by Waters Medical Systems You can use a common transport company Before shipping Clean the WAVES control unit as described in the Cleaning section on page 133 to avoid contamination Check the ice compartment and make sure it is empty and dry Remove the ice compartment lid Check the battery door is properly close Remove any old cassette Check the device is turned OFF Secure the WAVES in the shipping box Disconnect any cable network power USB and components USB flash drive Page 132 of 139 CLEANING The WAVES cabinet should be cleaned after each use First turn off the WAVES and disconnect the power Clean the WAVES using a soft cotton cloth and mild detergent such as dish soap or hydrogen peroxide and warm water Occasionally the ice compartment and pump should be cleaned using 10 household bleach solution This process is completed by running 250 ml of 10 bleach solution through the reservoir pump using the drain machine command to prevent mold Once the solution is completely pumped out through the drain line the reservoir should be wiped out with a dry cloth and left open to air dry If a commercial bactericide is used such as Cidex test on an inconspicuous part of the cabinet to determine there is no damage or stain to the p
59. lant water e Check batteries placement e Charge batteries e If problem persists call WMS technical support to replace battery 1 4 WAVES Actions e Alert the user USER Actions e Check batteries placement e Install battery WAVES Actions None User Actions e If problems persist call WMS technical support to control and or change the display or the controller WAVES Actions None User Actions e Calibrate touchpad e Change the display Battery 1 4 missing No message No message Ice container temp too high e Control controller board WAVES Actions Alert the user User Actions e Drain Ice container and replace ice WAVES Actions e Alert the user e Stop coolant pump User Actions e Check ice compartment and add ice and water if necessary Call WMS technical support if problems persist No ice and water in the ice container Please add ice and water Page 91 of 139 WAVES SOFTWARE TECHNICAL MENU DEFINITIONS AND GENERAL DESCRIPTION TECHNICAL MENU TABLE OF CONTENTS Technical Menu screen 1 Technical Menu screen 2 Technical Menu screen 3 Technical Menu screen 4 Technical Menu screen 5 Technical Menu screen 6 Technical Menu screen 7 Technical Menu screen 8 Technical Menu screen 9 Technical Menu screen 10 Technical Menu screen 11 Technical Menu screen 12 Technical Menu screen 13 Technical Menu screen 14 Technical
60. larm may be suspended under user control Power Center The power center includes medical grade power supply battery charger signal and power distribution functions The power center also has an automatic hierarchical power source switching system The power center accepts power from AC mains and 10 8 Volts Li Ion batteries Pulsatile Pump The pulsatile pump rate pulse per minute is fixed by software at 60ppm You can change the level of compression stroke volume of the silicon pumphead only by software update by changing the pressure value Cooling System The cooling system includes an ice water reservoir a coolant pump a heat exchanger and a heat exchanger base The pump controlled by software is cycled on and off to control the perfusate temperature Cassette Connection The Cassette connection is made by the cassette cable receptacle It permits the connection of the cassette cable connector to have access of the perfusate temperature and the pressure data provided by the disposable temperature and pressure sensors placed on the bubble trap Air Pump The air pump is used to blow room air through the oxygenator chamber This air pump is activated when the pulse pump is turned on One can also blow other gases such as oxygen using the external gas inlet port if approved by local protocol Page 137 of 139 APPENDIX C FLOW MEASUREMENT Measuring flow with the WAVES The WAVES system uses a TRANSONIC flow measure
61. layed in red until the problem is identified Example The systolic pressure is too high A red message box is displayed If you want to hide the message box please push OK Example The systolic is too high A sound is activated to alert the user If a new alarm occurs the sounds are reactivated automatically During an active perfusion if the system is not in the Main Perfusion screen Trend screens history screens drain screen the WAVES control unit goes automatically on the Main Perfusion Screen if any alarm occurs in order to be able to see the displayed parameters Page 85 of 139 WAVES WEBPAGE Sys Dia Flow 150 mL min WAVE S W e b P a g e software version xxxxx Real Time Data Data 40 mmHg Sys Dia D bit Temp XXXX XXXX XXXX XXX XXXX XXXX XXXX XXXX XXXX XXXX XXXX XXXX 20 mmHg ae E Temp 50 C ih MM XXXX XXXX XXXX XXXX RR 0 22 hh mm XXXX XXXX XXXX XXXX Trend Alarms History Alarms Alarms 1 Alarms 2 Alarms 3 Alarms 4 07 27 2011 06 49 00 07 27 2011 07 52 00 ID 10272611 Current Time Start end 07 27 2011 7 39 38 D Total perfusion time hours 1 03 Print The perfusionist can only see the perfusion parameters displayed and print a report consisting of Real Time Data Systolic diastolic and mean pressures flow temperature and renal resistance values as displayed on the device screen at that time real time CURRENT Data Systolic diastolic and
62. linical screen 13 Place sterile drape IF FIRST STERILE DRAPE WAS REMOVED FOLLOW DRAPE PLACEMENT PROCESS AS BEFORE MAKING SURE CASSETTE LIDS ARE REMOVED AND STORED ON A CLEAN STERILE SURFACE Once sterile drape is locked in place follow these instructions to place the kidney on the pump Aseptically raise the organ tray to the tray rest Place the kidney on the organ tray in the cassette and connect the artery s to a suitable perfusion clamp or cannula Debubble the artery and clamp cannula Finally attach the clam cannula to the arterial port At this step the WAVES control unit and the pulse pump system operate at a medium flow set in the technical menu to protect the kidney from over pressurization during the connection The WAVES automatically provides real time monitoring of the systolic pressure The pressure is displayed and set not to exceed a maximum pressure of 20mmHg preset in the technical menu The pressure may exceed 20mmHg for a brief time when connecting the kidney but then will reset to 20 mmHg If the systolic pressure reaches and exceeds the set value the system decreases the pressure to maintain the pressure at a value lower than or equal to 20mmHg set in the technical menu Pressing OK button to validate and go to the next step By pushing the Back button you can go to the Clinical screen 13 Place sterile drape This action stops both the pulse pump and air pump Page 53 of 139 e CLINICAL SCREEN 15 SET
63. mber button if you want to select the files by perfusion number Pushing the Back button you can go to the previous screen Page 72 of 139 o Perfusion history screen data selection Data Q2 01 2011 14 07 s 123456D 11 08 2011 14 15 23456067G 10 06 2011 16 20 456789G 10 05 2011 18 33 346890D 09 04 2011 11 56 536589D Back Eok EE Epok S One of these screens appears when the user pushes the Date or the Perfusion Number on the Perfusion History menu screen Please select the perfusion files you want to access by using the down and up arrows and push the OK button to validate your choice Two stars appear in front of the selected data Pushing the Back button you can go to the previous screen Page 73 of 139 o Perfusion History screen data table History data Time 14 12 14 13 14 14 14 15 14 16 14 17 Back Sys Dia Flow Temp 40 41 40 40 41 41 24 24 24 24 24 24 Transfer 01 11 2011 14 12 120 123 122 120 121 124 5 1 4 9 5 0 5 0 4 9 5 0 Chart RR 0 31 0 31 0 31 0 31 0 31 0 31 A y The selected perfusion files are displayed as shown A table gives you all the systolic and diastolic pressures the flow the perfusate temperature and the renal resistance values for the perfusion case You can consult the data by using the up and down arrows This screen displays also the beginning date and time of the perfusion and the perfusion num
64. mean pressures flow temperature and renal resistance values saved in the device for the actual perfusion The data are displayed from the newest to the oldest The first data is displayed on the top during the perfusion The webpage can display up to 15 hours of perfusion data CURRENT Trend A chart which represents all data saved in the device for the current perfusion for systolic and diastolic pressures and flow values Perfusion Alarms History This table lists the alarms that occurred during the perfusion Up to 16 alarms can be displayed for each case Perfusion Number Date and Time at the beginning of this perfusion allows total perfusion time to be calculated Page 86 of 139 The perfusion webpage can be printed for use in the recipient operating room by clicking on the Print button or using the Internet Explorer printing feature Per national standards the perfusion record should be printed and must become a permanent portion of both the donor and recipient medical records No change on the perfusion parameters or on the WAVES can be made from the website Network connection procedure Attach the WAVES to your network using a standard ethernet cable You may require permission from your IT department Turn ON the WAVES if not done so already Qn your network attached personal computer open Waters network scan application FindWaves exe Click on the Refresh button to look up the IP address for the WAVES
65. ment in only one position See Figure 7 for battery installation It is recommended to have spare batteries before transport F ol Note Connector Orientation Battery Pack Battery Door Figure 7 WAVES battery Page 15 of 139 Display User interface The display touchpad user interface screen allows the user to control the unit and provides the user with continuous controls and updates on the perfusion parameters During normal operation the display will provide real time perfusion parameters and will notify the user with information if problems occur during setup instructions or as a result of an alarm message The display also offers other menu options including password controlled technical menus and perfusion trending options The display provides current information in numerical format which includes systolic mean and diastolic pressures flow from the kidney and temperature of the perfusate and renal resistance of the kidney The perfusion measurements will be displayed at all times during an alarm The alarm system will signal an audio as well as a visual alarm for the user in selected alarm conditions See page 88 for alarms and their descriptions along with troubleshooting tips lt a amp SA q a Figure 8 WAVES touchpad display Pressure regulation The WAVES control unit has variable stroke volume control allowing the operator to adjust the motion of the pulsatile pump By adjusting the
66. ment permits temperature regulation in two ways Static heat exchange The cassette chamber is in direct contact with the ice compartment which keeps the cassette chamber environment cool Dynamic and automatic temperature regulation The ice compartment is connected to a cooling pump that transfers water from the tank to the heat exchanger This heat exchanger is designed in two parts 1 the heat exchanger base on the Waves control unit cassette compartment and 2 the heat exchanger plate on the WCM cassette During perfusion the perfusate circulates through the heat exchanger plate attached to the cassette The coolant pump circulates water from the ice compartment to the heat exchanger base After having circulated through the heat exchanger base the water returns to the ice compartment Page 19 of 139 Installing the cassette permits a direct contact between the heat exchanger base and the heat exchanger plate which provides perfusate temperature regulation Two temperature sensors regulate the perfusate temperature to the set perfusion value usually 5 C 0 5 C A disposable temperature sensor on the cassette measures the real time perfusate temperature The coolant pump is turned ON and OFF based on the perfusate temperature The coolant pump will stop when the perfusate temperature reaches perfusion temperature A second temperature sensor in the ice reservoir will provide an alarm message and the pump will stop the
67. ment system to measure the flow across the cassette tubing In this manner sterile perfusate does not come in contact with the flowprobe The flowprobe is non removable It uses a real time ultrasound signal method to insure precision measurements How the Flowprobe Work The Transonic flowprobe uses the transit time ultrasound method to accurately measure perfusate flow The flowprobe incorporates two transducers that generate ultrasonic beams which alternately intersect the perfusate The difference between the upstream and downstream ultrasonic beam transit times is a measure of volume flow The flowprobe is pre calibrated for use with the WAVES and perfusate Figure 21 WAVES Flow Sensor The WAVES will update the flow for the displayed value trend and graph the data and use this value in the renal resistance calculation Page 138 of 139 Appendix D Graphic Symbol Index Symbol for CAUTION Refer to accompanying documents Symbol for Batch Code Symbol for Date Of Manufacture Symbol for DO NOT REUSE Symbol for Catalog number Symbol for Serial Number STERILE EO Symbol for Sterilized Using Ethylene Oxide gt 0 YYYY MM Symbol for Use By Date referenced Year Month Symbol for Manufacturer Symbol for product 1s classed as Electrical or Electronic Equipment and is covered by the WEEE Regulations Please refer to Symbol for KEEP DRY Symbol for
68. n the local perfusion record Use aseptic technique when handling the cassette from the packaging When the user is prompted by the WAVES control unit s display the cassette can be mounted into the WAVES by aligning the cassette in the appropriate position on the open device surface see Figure 14 below The cassette will only fit into the device in one position When prompted the user should then secure the three cassette latches mounted on the control unit by rotating them into position between the bumps on the cassette The pulsatile pump will self align with the cassette pumphead in the cassette compartment The pressure transducer inlet tubing to the ambient air pump temperature probe and needleless sample port are integrated into the WAVES cassette The cassette 1s designed to be automatically aligned and connected to the flow transducer therefore all functions are ready for operation once the cassette is placed properly inside the device The temperature probe is also integrated into the cassette bubble trap and will control the ice water reservoir circulation pump and thermostatically maintain the temperature of the perfusate using the cassette sensor connection Cassette Latch 1 of 3 Locking position of cassette latch Page 22 of 139 Outer Lid with Locking Tabs Inner Lid Figure 15 WAVES cassette lids The WCM cassette has two sealed lids to prevent damage or contamination of the kidney from the external env
69. nt which has been subjected to negligence accident abuse misuse or other improper operation or has been tampered with or altered or repaired by anyone other than an authorized service representative of Waters Medical Systems The purchaser assumes all liability for all claims losses or damages incurred by the use or misuse of the instrument when placing and accepting delivery of an instrument supporting parts or disposables AT NO TIME SHALL WATERS MEDICAL SYSTEMS LLC THEIR EMPLOYEES REPRESENTATIVES OR THEIR DEALERS BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM OR CAUSED BY ANY DEFECT FAILURE OR MALFUNCTION OF ANY PRODUCT OR CLAIMS LOSSES DAMAGES OF ANY THIRD PARTY OR FOR LOST PROFITS OR INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND EVEN IF WATERS HAS BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGES THIS WARRANTY IS GIVEN EXPRESSLY AND IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED PURCHASER AGREES THAT THERE IS NO WARRANTY OF MERCHANTABILITY AND THAT THERE ARE NO OTHER REMEDIES OF WARRANTIES EXPRESSED OR IMPLIED WHICH EXTEND BEYOND THE DESCRIPTION ON THE FACE OF THIS AGREEMENT SOME STATES DO NOT ALLOW LIMITATIONS ON THE DURATION OF IMPLIED WARRANTIES OR EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR CERTAIN PURCHASES SO THE ABOVE EXCLUSIONS OR LIMITATIONS MAY NOT APPLY TO YOU THIS LIMITED WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS AND YOU MAY ALSO HAVE OTHER RIGHTS WHICH VARY
70. ort may be printed The WAVES has an Ethernet port on the back of the unit for network connection AC Power Network Cable Figure 4 WAVES network connectivity Page 13 of 139 Power and Batteries The WAVES operates on 100 to 240VAC 50 to 60 Hz or rechargeable Lithium Ion battery s to provide continuous power Two circuit breakers will disconnect the mains upon an internal short condition A Main power switch is available to start and or stop the WAVES The power switch must be held for a short period to start the device The start button will glow blue when the unit is powered on Battery operation lasts up to 12hourswith four fully charged batteries AC mains must be plugged in to re charge batteries i eS Ta pi y i 5 A a Circuit Breakers Re S Main Power Switch AC Power Battery Door Network Port USB Port Figure 5 WAVES back panel USB Flash Drive AC Power Network Cable Figure 6 WAVES back panel connections Page 14 of 139 Use only a hospital grade AC power cord as provided Use only batteries recommended by WMS Do not substitute batteries You have access to the batteries by a door on the back of the device No tools are needed to open the door To access the batteries unscrew knob as shown in Figure 7 and remove the door Make certain the batteries are in position and making contact with the unit prior to use The batteries can be placed in the compart
71. p Coolant pump rt 0 55 A Air pump This screen is displayed when you press Pumps button on the Technical Menu screen 21 Maintenance Menu You can check the good state of the coolant pulsatile or air pump by turning them ON or OFF and check the current of the coolant pump If the coolant pump current value exceeds 1 00 A continuously the pump requires replacing Pushing Back goes to Technical Menu screen 21 Maintenance Menu Page 121 of 139 e Technical Menu screen 30 Maintenance History Menu History Alarms history This screen is displayed when you press History button on the Technical Menu screen 21 Maintenance Menu You can view the history of the alarms by pressing the Alarms history button See the Technical Menu screen 31 Maintenance History Alarms Pushing Back button goes to Technical Menu screen 21 Maintenance Menu Page 122 of 139 e Technical Menu screen 31 Maintenance History Alarms History Alarms 05 27 2010 03 25 13 Battery 1 missing f 05 27 2010 03 37 18 Battery 2 missing 05 27 2010 04 45 19 Sys too high This screen is displayed when you press Alarms History button on the Technical Menu screen 32 Maintenance History Menu You can scan the alarms occurred during the corresponding perfusion Pressing U UP or arrow you can scan all alarms classified by date and time Pressing OK button goes to Technical Menu screen 30 Maintenance History Menu Pre
72. pping a device or part to WMS If you believe you need to return your instrument to WMS call Customer Service for a return and shipping information Return the WAVES to WMS in the original shipping packaging The original packaging will minimize delays and shipping damage It is strongly recommended the WAVES be insured for full purchase price in case of damage or loss Waters is not responsible for return shipping charges damage or loss All parcels should be shipped to our Rochester street address Instruction manual revision 3070055 001 Rev 6 2012 11 13 2011 All rights reserved Waters Medical Systems LLC Rochester MN USA Duplication or changes forbidden unless otherwise authorized by Waters Medical Systems LLC Page 2 of 139 WARRANTY Waters Medical Systems warrants that during a period of one year from date of shipment from the factory each new instrument sold or manufactured by Waters is free from defects in material or workmanship under normal installation use and service Waters Medical Systems agrees that any such defect shall be repaired or replaced at Waters discretion provided the part is delivered intact to the factory for examination with shipping costs prepaid by the owner Exceptions to this warranty include items or parts that require periodic replacement or calibration consistent with normal use and instructions Such items or parts are not covered under this warranty This warranty does not extend to any instrume
73. pressure regulation mode or Manual to activate the Manual pressure regulation mode Page 63 of 139 o Lock screen confirmation Perf ID 2156470 Confirm for transport lock Flow 120 nl mi no vs ANEY Transport af This message box is displayed if you want to lock the screen touchpad during a transport by pushing on the Transport button during a perfusion Please press on Yes if you want to confirm your choice and lock the screen or No you want to cancel your choice and keep the screen unlocked Perf ID 2156470 5 0 C eo Transport Display Lock Active This screen appears once the display is locked To unlock the display push on any area of the screen to display the unlocking confirmation message Page 64 of 139 o Unlock screen confirmation Transport Display Lock Active Display locked To unlock the display Press button 1234 in order Cancel This message box is displayed if you touch the screen touchpad when the screen is already locked Please press in the correct order the button 1 2 3 4 to unlock the screen Press cancel to keep the screen locked Transport display lock not disarmed Try again No Yes This message appears if the 1 2 3 4 buttons are not selected in the correct order or if you didn t push on these buttons Press yes to try again or no to cancel and keep the screen locked Page 65 of 139 o End perfusion confirmation Perf lID 2156470 e
74. ration By pushing and holding the power switch for 5 seconds Batteries are being charged if the WAVES is plugged into the A C power DISPLAY USER INTERFACE The user will interact using the touchpad display for all operations The display is a 4 3 touchpad LCD screen that provides a simple clear and user friendly interface and helps the user during set up and perfusion operations The touchscreen allows the user to access menus and to change all perfusion parameters as well as control the different functions of the device The following section provides a description of the main screens which appear on the display of the WAVES Page 34 of 139 SOFTWARE TABLE OF CONTENTS Device Initialization Screen Main Menu Screen Clinical Screen 1 User name Clinical Screen 2 Enter Donor Perfusion ID Clinical Screen 3a Confirm Donor Perfsion ID Clinical Screen 3b Error confirmation Donor Perfsion ID Clinical Screen 4a add Ice and Water Clinical Screen 4b NO Ice and Water Clinical Screen 5 Activate coolant pump Clinical Screen 6 Check cassette Clinical Screen 7 Install Cassette Clinical Screen 8 Cassette in proper position Clinical Screen 9 Add perfusate to cassette Clinical Screen 10 Turn ON pulsatile pump Clinical Screen 11 Wait fot Temperature Clinical Screen 12 Temperature at preset value Clinical Screen 13 Place sterile drape Clinical Screen 14 Place kidney Clinical Screen 15 Set perf
75. rend button on the Options screen On this screen you can have access to 4 different Trends Pressure trends Systolic and diastolic Flow trend Renal resistance trend Perfusate temperature trend You can switch between the different Trend by pushing on the corresponding button Press Flow RR Temp The Control button of the activated trend is displayed in white The others are in blue Page 70 of 139 e BATTERY STATUS SCREEN Batteries status 75 15 98 99 99 15 5hours 0 5hours 5hours 5hours 5hours You can have access to the battery status by pushing on the Battery Status button on the main Menu Screen Percentage of charge of each battery and The number of hours remaining for each battery A global percentage of charge and number of hours remaining is also available Pushing the Back button you can go to the main menu screen Page 71 of 139 e PERFUSION HISTORY SCREENS The following screen details the different steps to have access to the data history files o Perfusion History Menu screen Data Choose date or perfusion number BEIG Perfusion number This screen appears when you push the History button on one of the following screens Options screen Main Menu screen You have access to the previous perfusion data and can make your selection by date or by perfusion number Please push the Date button if you want to select the files by date Please push the Perfusion nu
76. rs pulse head and door latches e Follow air transport regulations when transporting the device e Visually inspect each WCM cassette to make certain all connectors sensors and associated tubing are secure before attaching the cassette to the WAVES e Check expiration dates on all disposable equipment and solutions prior to use Do not use any expired products with the device The use of expired product may impact the performance and the safety e Secure the kidney cassette covers and lids before moving or transporting the device e During clinical transport with an organ being perfused the device should be transported with an A C power cord and the recommended number of charged batteries in the unit e Make sure all renal arteries are properly cannulated and perfused e Make sure the cassette is sealed appropriately labeled and not leaking during perfusion Page 8 of 139 Disposable products provided by Waters Medical Systems are sterile Do not resterilize or reuse disposable products Training and research products WCM disposables and machine solution are available from WMS but should never be used for clinical perfusion These components are clearly marked NON STERILE and are not intended for clinical use Always use universal precautions and aseptic procedures with the WAVES perfusion device organs specimens and perfusate Use only solutions designed for hypothermic pulsatile perfusion Page 9 of 139
77. rvice listed on page 2 Page 6 of 139 STATEMENT OF INTENDED USE The WAVES is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation transportation and eventual transplantation into a recipient Description The device provides a simple and efficient method of organ preservation using a physiology based pulsatile pump and membrane oxygenator The system utilizes hypothermic temperatures and a machine preservation solution to provide organ preservation The device is designed to preserve one kidney by perfusing a machine perfusion solution through the organ s artery s while maintaining stable pressure oxygenation flow and temperature The device is not to be used for direct contact with any patient Clinical experience has shown that hypothermic pulsatile preservation of kidneys for transplant is a safe effective and cost efficient means of preservation Previous preservation system models of this type developed by WMS have safely preserved thousands of kidneys for transplantation Perfusion parameters are controlled and displayed by the WAVES These parameters are Systolic Mean and Diastolic pressure Flow Temperature and Renal Resistance Systolic pressure is set by the user and then controlled automatically by the WAVES Gn AUTO mode or by the user Gn MANUAL mode Other perfusion parameters flow and temperature are measured by the WAVES and displayed continuously for evaluation
78. s and information are also available Stop perfusion Only displayed when the pulse pump is OFF This command permits to end the perfusion and goes back to the Main Menu screen Battery symbol which permits to have a global view of the remaining charge of the batteries You can also push on this symbol to display a message box showing the percentage of charging of each battery and the estimated hours remaining Transport button you can lock and unlock the touchpad screen by pushing on this button After 60 seconds if no one touches the display the touchpad is automatically locked To unlock the touchpad you can touch any area of the screen to display a message box to confirm your choice When the AC line is plugged into a proper socket a symbol appears on the screen to alert the user the Main is plugged Page 62 of 139 e CLINICAL SCREEN 20 CONFIRMATION MESSAGE BOX o Change pressure control confirmation Perf 1ID 2156470 ee 5 0 C SYS 40 5 27 mmHg Choose the new pressure 20 control mode DITAN Auto mode must be reactivated every 6 hours FLOW 1 20 ml min Manual _ Auto 0 22 RES Transport a This message box is displayed when you want to change the pressure regulation control mode on the display panel if you push on the Auto Press or Manual Press button After 6 hours of perfusion in auto pressure control mode the manual mode is automatically activated Please press Auto to activate the Auto
79. set perfusion pressure Page 111 of 139 e Technical Menu screen 20 Settings Temperature Temperature Set the temperature value to be reached during the cooling process 5 O C This screen is displayed when you press Temperature button on the Technical Menu screen 4 Settings menu OK Please set the value of the temperature using the up and down arrows and press OK button to validate and go to the Technical Menu screen 4 Settings menu The system will regulate the temperature at this value during the initial cooling process and all clinical perfusion processes set value 0 5 C Page 112 of 139 e Technical Menu screen 21 Maintenance Menu Maintenance Battery pumps Sound History Screen Factory default Sensors Update Firmware This screen is displayed when you press Maintenance button on the Technical Menu screen 3 Menu Pushing Battery button goes to the Technical menu screen 22 Maintenance Battery 1 Pushing Sound button goes to the Technical menu screen 23 Maintenance Sound Pushing Screen button goes to the Technical menu screen 24 Maintenance Screen 1 Pushing Sensors button goes to the Technical menu screen 28 Maintenance Sensors Pushing Pumps button goes to the Technical menu screen 29 Maintenance pumps Pushing History button goes to the Technical menu screen 30 Maintenance History Menu Pushing Factory Default goes to technical menu screen 33 Maintenance F
80. ss Initial stroke button on the Technical Menu screen 14 Settings Pressure flow 1 Please set the stroke flow the system will operate during the kidney connection and until the beginning of the perfusion Perfusion main Screen The system displays the value of the stroke target and the value of the associated estimate flow TBD during the final validation Stroke 0 to 200 flow 0 1 mL min Stroke 300 to 500 flow 0 10 mL min Stroke 600 to 800 flow 20 80 mL min Stroke 900 to 1100 flow 80 150mL min Stroke 1200 to 1400 flow 150 230 mL min Stroke 1500 to 1700 flow 250 300 mL min Stroke 1800 2000 flow 310 350 mL min Stroke gt 2000 flow 350 400mL min You can increase or decrease the flow by pushing on the up or down arrow and push OK button to validate this value and go to the Technical Menu screen 14 Settings Pressure flow 1 Page 108 of 139 e Technical Menu screen 17 Settings Pressure Flow 4 Initial Pressure Set the pressure the system operates for the 2 first minutes of the perfusion 4 0 es This screen is displayed when you press Initial pressure button on the Technical Menu screen 14 Settings Pressure Flow 1 Please set the initial systolic perfusion pressure the system will operate during the first two minutes of the perfusion when the system first arrives on the Perfusion main screen This value is also the maximum value of systolic pressure that the system has to operat
81. ss OK to go back to the Clinical screen 4a add ice and water and add ice and water in the ice compartment Page 43 of 139 e CLINICAL SCREEN 5 ACTIVATE COOLANT PUMP Activation of the coolant pump This screen is displayed when you press the OK button on the keypad on the Clinical screen 4a Add ice and water An animated graphic of a pump operating is shown Please push OK to activate the coolant pump and go to the next step During perfusion the coolant pump is activated when the temperature is 0 5 degree Celsius higher than the temperature set in the Technical Menu user defined but usually 5 C and deactivated when the temperature is lower than 4 5 C The aim is to keep the temperature in the cassette at Perfusion Temperature 0 5 C 5 C 0 5 C By pushing Back you can reach the previous screen Clinical screen 4a Add ice and water Page 44 of 139 e CLINICAL SCREEN 6 CHECK CASSETTE Check cassette for integrity and note lot number and expiration date on perfusion record ca This screen is displayed when you press the OK button on the Clinical screen 5 Activate coolant pump Please check the cassette expiration date cassette integrity and note the lot number and expiration date on the perfusion record If you detect a problem you must change the cassette communicate the defect to the WMS technical support and return the damaged cassette If no problem is detected please press OK to validate
82. ssing Back button goes to Technical Menu screen 30 Maintenance History Menu Page 123 of 139 e Technical Menu screen 32 Maintenance Factory Default Factory default This action will erase all perfusion data from the device Please confirm this action NO EYESIS This screen is displayed when you press Factory Default button on the Technical Menu screen 21 Maintenance Menu Pressing NO cancels this action and goes back to Technical Menu screen 21 Maintenance Menu Pressing YES validates this action and erases all the data from the device then go to Technical Menu screen 21 Maintenance Menu Page 124 of 139 e Technical Menu screen 33 Maintenance Update Device Firmware 1 Update Device Firmware Connect USB Memory Stick Please confirm to check software version on USB Update will not occur yet A This screen is displayed when the user presses Update Device Firmware button on the Technical Menu screen 21 Maintenance Menu Pressing No to cancel this action and goes back to Technical Menu screen 21 Maintenance Menu Pressing Yes to validate this action and check if a USB flash drive is connected Page 125 of 139 e Technical Menu screen 34 Maintenance Update Device Firmware 2 Update Device Firmware SEEI Checking for USB This screen is displayed when the user presses Yes button on the Technical Menu screen 34 Maintenance Update Device Firmware 1 The WAVES is checking
83. ter By pushing Back button you can reach the previous screen Clinical screen 2 Enter Donor Perfusion ID Page 40 of 139 CLINICAL SCREEN 3B ERROR CONFIRMATION DONOR PERFUSION ID CONFIRM Donor perfusion ID 364926 Error on Donor Perfusion ID confirmation Please ey space If your confirmation of the Donor Perfusion ID doesn t match this message box is displayed Please push OK button to go back to the Clinical screen 2 Enter Donor Perfusion ID and enter and confirm the Donor perfusion ID Page 41 of 139 e CLINICAL SCREEN 4A ADD ICE AND WATER Add Ice and water in the cooling compartment This screen is displayed when the user presses the Enter button on the keypad on the Clinical screen 3a Confirm Donor Perfusion ID Fill the ice compartment fully and add to 1 liter cold water and press OK to confirm The ice and water permit the regulation of the perfusate temperature in the cassette By pushing the Back button you can reach the previous screen Clinical screen 3a Confirm Donor Perfusion ID Page 42 of 139 e CLINICAL SCREEN 4B NO ICE AND WATER Add ice and water in the cooling No Ice and water in the cooling compartment Please add ice and water OK The Waves control unit has a level sensor in the ice compartment If the minimum level of water is not detected before your press OK button on the Clinical screen 4a add Ice and water this message box appears Please pre
84. the connection of USB flash drive and searching for a new firmware version If the USB is detected the Technical Menu screen 36 Maintenance Update Device Firmware 3 is displayed If not a message box appears Technical Menu screen 38 Maintenance Update Device Firmware 5 Page 126 of 139 e Technical Menu screen 35 Maintenance Update Device Firmware 3 Update Device Firmware Current Version is 01 00 02 Version on USB Its 01 00 03 Do you want to update This screen is displayed when the USB connection is detected Pressing No to cancel this action and goes back to Technical Menu screen 34 Maintenance Update Device Firmware 1 Pressing Yes to validate the action and start the firmware update Page 127 of 139 e Technical Menu screen 36 Maintenance Update Device Firmware 4 Update Device Firmware The screen will go blank in 5 seconds The WAVES will reboot after beeping stops Please don t touch This screen is displayed when the user presses Yes on Technical Menu screen 36 Maintenance Update Device Firmware 3 This screen is displayed during 5 seconds before the Waves reboots While the WAVES is loading the new software do_not turn the unit off If the power fails during this operation the programming will be incomplete and the unit will be inoperable and the unit will need to be returned to Waters for re programming Page 128 of 139 e Technical Menu screen 37 Maintenance Update Device
85. the value then press OK button to validate the modification and go to the Technical Menu screen 4 Settings menu Page 104 of 139 e Technical Menu screen 13 Settings Networkin Enter static IP Adress 190 168 0 17 l This screen is displayed when you press Networking button on the Technical Menu screen 4 Settings menu This section permits you to change if necessary the IP address of the WAVES control unit for networking communication You may require assistance from your network administrator Please enter the IP address and push Enter button to validate Pushing Back button you can go back to the previous step Technical Menu screen 4 Settings menu Page 105 of 139 Technical Menu screen 14 Settings Pressure Flow 1 Pressure Flow Cooling process Initial flow Initial Press Perfusion Press Auto Press Back This screen is displayed when you press Press flow button on the Technical Menu screen 4 Settings menu Please select the section you want to set the value you need Pushing Cooling process button goes to the Technical Menu screen 15 Settings Pressure Flow 2 Pushing Initial stroke button goes to the Technical Menu screen 16 Settings Pressure flow 3 Pushing Initial Press button goes to the Technical Menu screen 17 Settings Pressure flow 4 Pushing Perfusion Press button goes to the Technical Menu screen 18 Settings Pressure flow 5 Pushing Auto Press button goes
86. to the previous screen Clinical screen 6 Check Cassette Page 46 of 139 e CLINICAL SCREEN 8 CASSETTE IN PROPER POSITION Cassette in proper position This screen is displayed if the cassette sensors are detected and verified on the Clinical screen 7 Install cassette This screen is displayed for 5 seconds and automatically goes to Clinical screen 9 place sterile drape Page 47 of 139 e CLINICAL SCREEN 9 ADD PERFUSATE TO CASSETTE Add 1L of PPS solution to cassette using aseptic technique aas This screen is displayed when you press the OK button on the Clinical screen 8 cassette in proper position Add 1 liter of pulsatile perfusion solution into the cassette using aseptic technique and press OK button to validate and go to the next step At this point the space where the device is located can be isolated and the cassette can be allowed to reach temperature 5 C with the cassette open OR Cassette lids can be aseptically replaced onto the cassette to speed cooling To further speed the initial cooling process the outer lids of the device need to be closed to enhance cooling Pushing the Back button you can go to the previous screen Clinical screen 6 check cassette Page 48 of 139 e CLINICAL SCREEN 10 TURN ON PULSATILE PUMP Pre cooling process Turn ON the pulse pump a Bia Y i id ae OK This screen is displayed when you press the OK button on the Clinical screen 9 A
87. ture at preset value soccl This screen is displayed when preset temperature is reached on the Clinical screen 11 wait for temperature At this step the target flow rate is decreased to a medium value set in technical menu This screen is displayed during 5 seconds and the system automatically goes to the next steps Clinical screen 13 place kidney As a safety measure you cannot move forward in the perfusion process until the temperature is reached Page 51 of 139 e CLINICAL SCREEN 13 PLACE STERILE DRAPE Place sterile drape cg This screen is displayed when you press the OK button on the Clinical screen 12 Temperature at preset value Change into a sterile gown and gloves Remove the two cassette lids using aseptic technique and place the lids on a sterile surface for later use Remove the sterile drape from the packaging and place it on the cassette to protect the device and keep the cassette sterile The sterile drape should be locked on the cassette Push OK button using aseptic technique through the sterile drape to validate and go to the next Step The sterile drape must completely cover the surface of the WAVES including the display and the doors Pushing the Back button you can go to the Clinical screen 10 Turn On pulsatile pump Page 52 of 139 e CLINICAL SCREEN 14 PLACE KIDNEY Place kidney in cassette 20 This screen is displayed when the preset temperature is reached on the C
88. uring the testing of the main component The message that shows the state of the device during the main component testing is Testing During this autotest I O are initialized and pulsatile pump is initialized to its home position Touchpad Calibration of the touchpad if needed IGL group website For more information log onto www igl group com Page 36 of 139 e MAIN MENU SCREEN Choose operational mode Clinical Perfusion Technical menu History Coolant drain Battery status Shut down This screen is displayed at startup of the device The Main Menu gives the user 6 choices Push one of the 6 buttons to select the desired action Clinical Perfusion Screen To initiate perfusion by going to perfusion screens Perfusion History To access of all perfusion data stored in the device Battery Status To check the charge of each battery Technical Menu To access to the technical settings of the device secured by password Only administrator may access the technical menu If you lose your password please call WMS technical support to reset Coolant drain To drain the Ice compartment Shut down To shut down the system In the following sections each screen will be discussed in detail and the rational for moving from one screen to another will be provided A perfusion session can only be started after moving through the steps as described in the following pages Page 37 of 139 e CL
89. usion pressure Clinical Screen 16 Pressure control mode Clinical Screen 17a Confirm Auto pressure control mode Clinical Screen 17b Confirm Manual pressure control mode Clinical Screen 17c Time to reach perfusion pressure Clinical Screen 18 Starting perfusion Clinical Screen 19 Main Perfusion Window Clinical Screen 20 Confirmation message box Clinical Screen 21 Change perfusion pressure message box Clinical Screen 22 Batteries status message box Option Screen Trend Screen Battery Status Screen Perfusion History Screen Coolant drain screen Shut down screen Alerts screen Alarms Screen 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 63 67 68 69 70 71 72 80 82 84 85 Page 35 of 139 e DEVICE INITIALIZATION SCREEN Waters Medical Systems WAVES Transplant Center Testing For more information log onto www igl group com When the power is turned on this initial WAVES screen is displayed during a brief time two seconds during internal testing No action of the user is needed The following information will be displayed Name of the manufacturer Waters Medical Systems Name of the device WAVES The unit s owner OPO or Transplant Center Name The user can change the name of the OPO or transplant center by entering the password protected area of the technical menu A message showing the current state of the device d

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