Jarvik Heart, Inc. 333 West 52 nd Street New York, NY Phone (212) Fax (212) Patient Handbook U.S.

Transcription

1 Patient Handbook Page 1 of 29

2 Patient Handbook Appendix K Clinical Protocol G Table of Contents 1. Your Personal Jarvik 2000 Card Precautions and Warnings Potential Complications Proper Positioning Of the Jarvik 2000 Abdominal Cable Operating the Jarvik 2000 System Intermittent Low Speed FlowMaker Controller Basic Function of the FlowMaker Controller Setting the Pump Speed The Power Indicator Lights Alarms and Warnings (Including Procedure to Resolve the Pump Stopped Alarm) Backup Power for the Alarms Batteries The Portable Li-Ion Batteries and Charger The Reserve Lead-Acid Battery & Charger Cables and Cable Connectors The Y-Cable Copyright 2008, All rights reserved. Printed in U.S.A. Page 2 of 29

3 1. YOUR PERSONAL JARVIK 2000 CARD Make sure to fill this card before you leave the hospital. The contact person from the Jarvik Heart Team in the hospital is trained to help you with the Jarvik 2000 equipment. It is important to always have this card with you in case something happens to you or your pump. Patient Name: Patient ID Card Address: City: State, Zip: Phone: Personal Contact Name: Personal Contact Phone: Hospital Name: Hospital Address: Jarvik Heart Team Contact information City: Implant Date: State, Zip: Serial number: Contact Person: Contact Person Phone: HOTLINE: Page 3 of 29

4 2. PRECAUTIONS AND WARNINGS The Jarvik 2000 FlowMaker Controller, batteries, cables, and connectors are subject to damage from neglect or misuse during daily operation. Handle this equipment carefully as you would a video camera or other delicate electronics equipment. The connectors are plastic and may break if not handled cautiously. Protect the cables from damage which can be caused by pulling, cutting, heat, liquids or chemicals. The FlowMaker Controller contains electronic components. The controller case protects these components from shock and liquids. The case and internal components are subject to damage if dropped. The batteries may be damaged if dropped. The cables and connectors can break or shortcircuit if over stressed or pulled and should always be protected from catching on objects, or being kinked, twisted, or tangled. Never lift or hang the FlowMaker Controller or batteries by the cables. The FlowMaker Controller and batteries should be kept at temperatures above 32 o F (0 o C) and below 110 o F (43 o C). Do not leave them in hot or cold environments, such as the trunk of a car in the summer or winter. As a precaution, always keep the equipment at or near room temperature. When exposed to cold temperatures for an extended period, maintain the control system and batteries under your coat. The FlowMaker Controller and Li-ion batteries are splash resistant but not waterproof. Any liquids spilled on them should be cleaned off immediately with a clean dry cloth or paper towel. It is safe to shower with the pump implanted. Based on the healing of the surgical wound, your physician will decide when you can do so. When you take a shower, be sure to place the FlowMaker Controller and batteries outside of the shower area and cover them with a dry towel or bag. The plug-in battery chargers are not splash resistant and must be kept dry and protected from spills. Page 4 of 29

5 The large reserve battery used during sleep must also be kept dry and should never be plugged into wall power when in use to run the pump. The large reserve battery should only be plugged into wall power when recharging the battery. You should never have magnetic resonance imaging (MRI) done. The magnetic field may interfere with the function of the pump leading to pump stoppage or may injure you. Routine diagnostics such as X-rays, echocardiography and CT-scans have no influence on the performance of the pump. The Jarvik 2000 Heart incorporates a Hemashield Vascular Graft. This graft should not be implanted in patients with a known sensitivity to products of bovine origin. You do not have a battery implanted to run the pump. Your pump will stop if the FlowMaker Controller is disconnected from the pump cable. It will also stop if the controller is disconnected from the Y-cable or battery cable. You should reconnect the cables immediately to restart the pump. The small ½ AA battery in the FlowMaker Controller powers the alarms only and is not sufficient to run the pump. Replace this battery every two months. The Jarvik 2000 Heart never runs from wall power even if the reserve battery charger is plugged into the wall. At all times, the pump is only run from batteries. If the gray plug from the reserve battery is plugged into the FlowMaker Controller and the black power plug is plugged into the wall you still are receiving power only from the battery. All external cables should be replaced after 6 months of use for all patients supported with the Jarvik 2000 system. These include: o External Abdominal Cable from Pump to Controller. o The Y-Cable from the Controller to the Li-ion Battery Cable. o The Li-ion Battery Cable from the Y-Cable to the Li-ion Battery Pack. Please make sure that all your external cables are replaced after 6 months of use. If not, please notify the contact person from the Jarvik Heart Team in the hospital, they will provide you with new external cables. Page 5 of 29

6 3. POTENTIAL COMPLICATIONS The possibility exists that serious potential complications may arise from the use of the Jarvik 2000 Heart. Potential Complications: the potential complications associated with the use of the Jarvik 2000 Heart include: Death Excessive bleeding Reoperation Thromboembolism (blood clots that form and can travel to other parts of the body) Device thrombosis (blood clots around the device) Systemic hypotension (low blood pressure) Failure to the right side of the heart Cardiogenic shock (inability of the heart and the device to supply an adequate amount of blood to the body) New myocardial infarction (heart attack) Cardiac mural thrombi (blood clots on the walls of the heart) Cardiac arrhythmia (irregular heart rhythm) Coagulopathy (a condition in which the blood cannot clot properly) Infection Hemolysis (the destruction of red blood cells) Liver dysfunction Kidney dysfunction Lung dysfunction Mechanical failure (the assist device or one of its components might fail to operate) Stroke or neurological dysfunction Air emboli (air entry into the vascular system) There may be additional risks which are presently unknown. Page 6 of 29

7 4. PROPER POSITIONING OF THE JARVIK 2000 ABDOMINAL CABLE The implantation, positioning, and external fixation of the implanted cable can affect cable durability for long term patients. The objective of proper positioning is to maximize the length of velour covered cable tunneled subcutaneously, to achieve the best tissue in-growth as a barrier to infection, and to permit practical stabilization of the external portion of the cable to prevent flex fatigue failure. The following diagram illustrates Jarvik Heart s recommended implantation position. Only a few centimeters of exposed velour should be located outside the skin. The recommended length of cable (including the silicone strain relief) outside the skin should be 6-7 cm, and should not exceed 9 cm. We recommend that the cable should be gently curved and the connector of the replaceable external abdominal cable should be taped to the skin to immobilize it, which will also immobilize the cable that is attached to the blood pump. The position of the cable and the tape may be varied somewhat each time the tape is changed. Make sure that the abdominal cable exiting your stomach is taped to your skin at all times (as shown in the diagram on the following page). This is an important safety step to take in the event that there is a sudden pull or excessive force on the cable. This precaution should be followed the whole time you are supported with the Jarvik 2000 pump, not just in the hospital. Page 7 of 29

8 5. OPERATING THE JARVIK 2000 SYSTEM The Jarvik 2000 Heart is a miniature rotary pump called an axial flow pump. It is the size of a C cell flashlight battery and is surgically positioned within your heart. Electric power is supplied to a motor within it through a small cable that passes into the body through the abdominal wall and then to the Jarvik 2000 Heart. This cable has a black connector on the end of it which must be plugged into an external cable which is in turn connected to the FlowMaker Controller. This controller converts the direct current electricity from the battery to the proper type of electric power to run the motor at the selected speed. Page 8 of 29

9 The Jarvik 2000 Heart is designed to act as a true booster pump and permits your natural heart to do as much of the pumping work as possible. Connector to Pump cable Y Cable FlowMaker Controller Li-ion Battery 6. INTERMITTENT LOW SPEED FLOWMAKER CONTROLLER The Intermittent Low Speed FlowMaker Controller provides five user settable speeds. The Intermittent Low Speed function of the Jarvik 2000 Controller reduces the set pump speed to 7,000 rpm for a period of eight seconds after each fifty-six seconds. During this eight second period, flow through the pump will briefly decrease and in some patients the ventricle may eject blood through the aortic valve. Page 9 of 29

10 7. BASIC FUNCTION OF THE FLOWMAKER CONTROLLER The FlowMaker Controller provides power to the implanted blood pump, provides user settable speeds at which the pump runs, and provides alarms and warnings. The rechargeable Li-ion battery pack permits portable use in a comfortable wearable configuration. The reserve batteries power the pump during sleep and provide over 2 days of backup emergency power in the event of a local power blackout. Backup units for the control system, batteries, cables and battery chargers are provided. A Y-cable is provided to allow battery changes without stopping the pump. Speed Setting Knob 8. SETTING THE PUMP SPEED Only one control adjustment to the Jarvik 2000 can be made, namely the speed at which the pump is running. The pump speed can be selected by turning the knob on the side of the controller so that the selected setting number appears in the window on the top panel. In general, the higher the setting number the more blood the Jarvik 2000 will pump. The numbers on the dial show how fast the pump is running: 1 is the slowest and 5 is the fastest. The top panel has the symbol of a propeller to represent pump speed. The large propeller with the arrow next to it indicates the direction to turn the knob to increase the speed. Page 10 of 29

11 The control system does not measure the actual blood flow that the heart is pumping. The flow estimates shown in the table below are based on research measurements in healthy animals. This represents only the flow through the Jarvik 2000 Heart. In some cases the natural heart may pump in addition to this. The actual blood flow may vary and will depend on several factors including blood pressure and the condition of your natural heart. Setting Number Pump Speed Approximate Flow 1 8,000 RPM 1-2 L/min 2 9,000 RPM 2-4 L/min 3 10,000 RPM 3-5 L/min 4 11,000 RPM 4-6 L/min 5 12,000 RPM 5-7 L/min After your doctor has evaluated your condition, instructions are provided on how to select the speed setting to be used at any time. In general, a lower speed may be selected during sleep, an intermediate speed may be used most of the day, and a higher speed may be used occasionally during exercise. CAUTION: If the pump speed is turned to setting 4 or 5 during exercise always be sure to turn the setting back down to the proper number for rest when exercise is stopped. Page 11 of 29

12 9. THE POWER INDICATOR LIGHTS The numbers 3 through 13 appear across the top of the control panel with a picture of an electric plug below the numbers. These numbers indicate the electrical power (Watts) that the pump is using. One or two numbers may be lit at any moment, and the lights may change rhythmically with the heartbeat of your natural heart. All lights are green except 13 which is amber. The number 13 indicates 13 Watts or more. The number 3 indicates 3 Watts or less. The control system measures the amount of electric power that the Jarvik 2000 is using in watts and lights that number on the panel. The amount of power used generally increases when the speed of Jarvik 2000 is increased. The following are typical values: Setting Number Approximate Power (Watts) During the course of your recovery the amount of power that the Jarvik 2000 uses may change. For an initial period of time after the implant operation, the lights may not blink rhythmically. Later they may begin to blink which indicates how fast the natural heart is beating. One may notice that exercise makes the lights blink faster. It is useful for you to keep a record of this information. If the condition of your natural heart improves or deteriorates, this information will help your doctor to understand the changes that have occurred. This information may also be helpful if a problem with the Jarvik 2000 occurs. Page 12 of 29

13 10. ALARMS AND WARNINGS (INCLUDING PROCEDURE TO RESOLVE THE PUMP STOPPED ALARM) The FlowMaker control system monitors the pump speed, the power consumed, and the battery. Alarms are communicated to the user by both a visual indicator and an audible alarm. All alarms require immediate attention. Warnings are communicated to the user by a visual indicator. All warnings require appropriate corrective action. The following table briefly summarizes all Alarms and Warnings for the Jarvik 2000 Heart: Alarm or Warning Alarm (audible) Visual Indicator Pump Stopped Alarm steady tone steady red High Power Alarm steady tone steady amber/yellow Low Battery Alarm Intermittent beeps steady yellow Underspeed Indicator Warning - steady yellow ALARMS PUMP STOPPED ALARM The pump stopped symbol is shaped like a stop sign with a bell inside it. If the pump stops or if the pump speed drops to below 5,000 RPM for any reason, a steady alarm sound is heard and the Pump Stopped symbol on the control panel lights red. The pump stopped alarm will also sound if the intermittent low speed feature on a FlowMaker controller (ILS) fails to function for any reason. There should never be a time when power is removed from the pump. You should not remove cables etc. even for dressing unless under supervision. If power to the pump is interrupted, the pump will stop and the Pump Stopped Alarm will sound. CAUTION: If the steady alarm sound is heard at any time other than when cables are disconnected, immediate attention is required. Page 13 of 29

14 Procedure To Resolve Pump Stopped Alarm Ccondition for Jarvik 2000 Heart Abdominal Cable Model Only The most likely reason for the pump to stop is a completely discharged battery or a disconnected or damaged cable. If the cause of a component failure is clearly identifiable (i.e. low battery, physical damage, etc.) replace that cable or component first. If the cause is unknown, follow these step-by-step instructions with the assistance of a support person. The patient should sit down or lie down. This procedure should be completed quickly. Back-up equipment must be immediately available. 1. Be sure the alarm is not an intermittent beeping which only indicates a low battery. If the alarm is beeping, change the battery as usual. 2. If the pump is stopped (steady alarm sounding, red light on): a. Disconnect the abdominal cable from the blood pump cable at the abdomen, and set aside all the attached components. Disconnect the Li-ion battery cable and also partially unscrew the ½ AA cell battery cap on the Flowmaker controller to silence the alarm. b. Plug the blood pump cable (the short length exiting the skin) directly into the backup Flowmaker controller (eliminating the abdominal cable). Make sure to tighten the ½ AA cell battery cap on the backup Flowmaker controller to activate the alarm. c. Using the backup Li-ion cable plug a fully charged Li-ion battery into the Flowmaker controller. d. If the pump now runs and you are feeling well, red tag the original components that you put aside in step 2a. You may then try replacing each of your backup components (presently working), one at a time, with components that you tagged, to identify the original component that had failed. 3. If the pump is still stopped call your medical emergency number immediately. 4. Red tag all components of the system that you set aside before you changed to the backup components in step 2a. This should be done with the assistance of a medical support person if possible. 5. Be sure that all external cables and connectors have been changed and check to see if the connector permanently attached to the heart is broken. If it is broken and has come apart put it back together where it is broken. If the heart does not run, take the connector apart again rotate the parts 90 and put it back together again. Repeat three times. The heart may start. The connector may then be held together with tape while you go to the hospital for it to be repaired. 6. If the heart still has not started, lie down and have your support person double check batteries and connectors. Try changing batteries again. It is possible that you accidentally removed a discharged Li-ion battery and then plugged the same Li-ion battery back in by mistake. It is possible that neither battery is charged. If no lights illuminate on either battery you must use a third battery. Use your Reserve battery if it is with you. Page 14 of 29

15 7. If you have followed all of the above steps (1-6) and have carefully replaced all cables and components without successfully restarting the pump (the alarm is still sounding) and you are confident that all of the external cables and components have been replaced, and all attempts to restart the pump still fail, disconnect the power to the Jarvik 2000 Heart by unplugging the battery. Also partially unscrew the ½ AA cell battery cap on the Flowmaker controller. (The alarm should stop sounding).there could be a problem with the external portion of the pump cable that can be repaired without surgery. If you leave the Li-ion or Reserve battery connected, the Flowmaker controller will apply power to the pump which could be harmful. Disconnecting the battery reduces the chance of a clot forming inside the pump by allowing the rotor to spin as blood flows across it. Note: Return any failed or suspect component(s) to your Clinical Center for evaluation by Page 15 of 29

16 HIGH POWER ALARM If the control system measures 13 watts of power or more this indicates a malfunction. The number 13 will light amber and an alarm will sound. This condition should receive prompt attention. Immediate medical assistance is required. LOW BATTERY ALARM When the battery powering the pump is low (about 5-10 minutes of running time remaining with the portable Li-ion battery) the low battery symbol on the control panel lights yellow and the alarm sound beeps. This condition requires attention since when the portable battery becomes fully discharged the pump will stop. Although the portable Li-Ion Battery Pack will have enough power to continue operating the heart for 5-10 minutes, recharged batteries should always be kept immediately at hand and the battery should be changed when the alarm sounds. The Reserve Battery will continue to operate for much longer than the portable Li-Ion Battery Pack after the low battery alarm begins to sound (over 15 minutes). WARNINGS UNDERSPEED INDICATOR The underspeed light comes on when the controller detects that the pump speed is slower than the dial setting selected. No alarm sounds. The under-speed light was intended as a method to confirm that the pump is running up to speed. If the underspeed light is not glowing, this means the pump is running as fast as the dial Page 16 of 29

17 indicates. It was originally included in the system to help detect a situation where there was increased resistance to rotation such as worn bearings or rubbing pump blades. However, this has never occurred in any patient. The yellow underspeed indicator light on the Flowmaker Controller warns that the pump is running slower than the speed indicated on the dial setting. If this occurs, and there are no clinical indications of a problem with the patient s condition, the most common reason is the battery voltage is too low. In this case, corrective actions are to: 1) Select a lower speed setting on the Flowmaker Controller and/or 2) Increase the voltage available to the controller. To increase the voltage, change to a fully charged battery and/or change from a reserve battery to a lithium-ion battery. If the underspeed indicator light is still lit, then the cause may be a fault in the system and the appropriate corrective actions are to 1) Replace all external components; and if the underspeed light is still on after replacing all external components, 2) Treat the situation as an emergency and seek immediate medical attention. About Low Voltage Activation of the Low Speed Indicator Voltage may be too low to sustain the selected speed when (1) running at speed setting 5 on the Li-ion battery at some point before the battery is half discharged, (2) running at speed setting 4 on the Reserve battery at some point before the battery is half discharged; (3) running at speed settings 5 on the Reserve battery even when the battery is fully charged. CAUTION: If the underspeed light stays on after taking all corrective actions, this indicates a problem with the cables, battery, controller, or the Jarvik 2000 Heart. This condition should receive prompt attention. Immediate medical assistance is required. Page 17 of 29

18 11. BACKUP POWER FOR THE ALARMS ½ AA cell A small non-rechargeable ½ AA cell battery is used to assure that control system has enough power for the alarms if the main battery fails, if the battery cable fails, or if the main battery becomes accidentally disconnected. This battery is located in a small housing on the end of the control system between the connectors for the Jarvik 2000 cable and the main battery cable. The ½ AA cell may be placed into its housing with either the plus (+) or minus (-) side inserted first. The cap holding the battery in place must be screwed all the way down in order for the battery to work. To check that it is working, briefly unplug the main battery powering the heart from the Y-cable. The pump will stop while the battery is disconnected and you will hear the alarm sound. Then immediately plug the main battery back in. The pump will begin to run and the alarm will stop. If the alarm does not sound when you disconnect the main battery, change the ½ AA cell for a new one and repeat the procedure. CAUTION: This test should be done only by operator, or patient under supervision Recommendation: Replace this battery every two months. Use only batteries that are obtained from Any time the main battery is disconnected the Jarvik 2000 will stop and the alarm will sound. The small battery does not have enough power to run the Jarvik 2000 Heart for even a short time and is only used to power the alarms. You must keep a backup FlowMaker Controller together with a charged backup battery and a complete set of backup cables with you at all times. The small battery in the backup controller may be left in its housing and the cap loosened just until the alarm goes off. An O-ring which seals the battery chamber from fluid spills will keep the lid from coming off as long as it is not loosened too much. Page 18 of 29

19 If a change to the backup control system is needed, one should be sure to tighten the battery lid to activate the back-up alarm battery. 12. BATTERIES Two types of batteries are provided; each type comes with its specific charger: 1. Portable gray Li-ion batteries (3 provided): each Li-ion battery provides power for the Jarvik 2000 Heart for 7-12 hours under usual conditions. 2. Reserve Lead-acid batteries in a red case (2 provided): each Reserve battery provides power for the Jarvik 2000 Heart for 24 hours under usual conditions. All are connected to the FlowMaker controller through the Y-cable using a gray plug with single key. The Y-cable will be discussed later in this handbook. 13. THE PORTABLE LI-ION BATTERIES AND CHARGER Li-ion Battery Pack The portable Li-ion Battery Pack has enough power to run the Jarvik 2000 Heart for 7-12 hours under usual conditions. Our recommendation is to rotate use of all portable Li-ion batteries, so they each get the same approximate use. Rotation helps assure that no battery pack is left for long periods of time without recharging, and that batteries are kept in the fully charged condition as much as possible. Each battery can be recharged hundreds of times. Eventually, as the number of times the pack has been recharged increases, fully charged Li-ion battery packs will power the Jarvik 2000 Heart for less than 7 hours. Although, the battery still powers the heart and will continue to function properly over many additional recharge cycles, the amount of time it will last before requiring charging will continue to decrease. Therefore, when a Page 19 of 29

20 Li-ion Battery Pack lasts less than 7 hours under usual use, from the time it is fully charged until the low battery alarm, it is time to retire that Li-ion battery pack and replace it with a new one. Each Li-Ion Battery Pack has an indicator with five lights which indicates how much power is remaining. Depress the black button and this turns on the indicator lights. Three lights are in the green zone, one in the yellow zone, and one is in the red zone. The approximate amount of time remaining is as follows: Indicator** Li-ion Battery Pack - NEW Li-ion Battery Pack Ready for Retirement Approximate Time Remaining until Low battery Alarm* ~ 8 12 hrs. < 7 hrs. Operating range with ALL 5 LEDs lit ~ 6 10 hrs. - Operating range with 4 LEDs lit ~ 5 8 hrs. - Operating range with 3 LEDs lit ~ 3 5 hrs. - Operating range with 2 LEDs lit ~ 5 min 2 hrs. - Operating range with 1 LED lit * Note: Actual operating times may vary depending on equipment, environment, and use conditions. Operating time decreases as the speed setting is increased from 1 to 5. ** Note: All LEDs are green, however the background zones are color coded. Li-ion Battery Charger Page 20 of 29

21 The Li-Ion Battery Charger has a black power cable to plug into the wall, and a smaller black cable to plug into the Li-ion Battery Pack. This smaller cable (~24 inches long) has a gray and white connector plug which fits into the Li-ion battery pack receptacle. The charger has two status lights on the top panel. A green light indicates connection to wall power. The second light flashes yellow during charging and turns green when the battery pack is charged. Prior to attaching a Liion Battery pack for charging, plug the charger into main power. The yellow status light will flash and then change to green as the unit completes a self test. After the yellow light stops flashing, turns to green and goes off, you can connect the battery for charging. During charging the status light will flash yellow. Please allow approximately five hours to fully recharge a fully discharged Li-ion battery pack. The Li-ion pack may be damaged if it is dropped onto a hard surface. The indicator lights and a black membrane switch are also subject to damage and should be protected. Do not press the black membrane switch with pointed or hard objects. Protect the Li-ion battery pack from impact. If any of the lights are damaged they may not light up when the black button is depressed. The battery pack will still function properly, and may continue to be used safely; however more careful attention to the amount of time that pack has been used since recharging is recommended. The Li-ion pack includes an attachment device to permit the FlowMaker controller to be mounted onto it. Hold the gray pack and slide the black tongue of the controller box into the gray groove on the battery pack. When these two components are joined in this way, never lift them by the black box only. The gray pack could slide out of the tongue and groove attachment device and fall. Always directly hold the gray battery pack whenever handling it. 14. THE RESERVE LEAD-ACID BATTERY & CHARGER The reserve battery and charger are combined in a single unit which is provided in a red (maroon) colored fabric carrying case with a shoulder strap. The pack provides power for times when you are not using a wearable battery, such as at night. Page 21 of 29

22 Reserve Lead-acid battery and charger in bag FlowMaker Controller Note that the pack is quite heavy (15 lbs) and the fabric case has a rubbery non-skid material on the bottom. When practical, the carrying case should be placed on the floor because then it is impossible for it to fall. If it needs to be placed on a table, be sure to place it on a clean hard surface. These batteries have an 8 foot long gray cord with a gray plug that plugs into the Y-cable connected to the FlowMaker control box. The carrying case has two fabric loops to hold the clips on the control system box. When using the reserve battery, keep the control system and Y-cable in place on these loops and connect the elastic retention strap to prevent the controller from being accidentally pulled away. If the controller is attached to the maroon case, keep the long gray cable neatly coiled in the side pouch of the case. Be careful never to put stress on the 8 foot long battery cable. The FlowMaker controller must be connected to the Jarvik 2000 Heart by the long black extension cord. The reserve battery has one receptacle on the top (or on the side for older models), and a cable with a gray plug which fits both the receptacle on the pack, and the Y-cable or FlowMaker Controller. There is also a removable black power cord which plugs into the other side of the unit and into a wall plug. The wall plug only charges the battery. If the gray plug is plugged into the FlowMaker Page 22 of 29

23 Controller and the black power plug is plugged into the wall you still are receiving power only from the battery. NOTE: The Jarvik 2000 Heart never runs from wall power even if the reserve battery charger is plugged into the wall. At all times, the pump is only run from batteries. Prior to plugging the reserve battery into the Y-cable, attach the FlowMaker Controller onto the carrying case by sliding the two belt clips down over the loops on the battery case. Retain the controller in place with the Velcro strap. Next, plug the gray reserve battery cable into the Y-cable prior to unplugging the portable battery. This assures that the Jarvik 2000 Heart does not stop and helps prevent stress on the short cable which could damage it if it were pulled too hard. When fully charged, the reserve battery has enough power to run the heart for over 24 hours. When the reserve battery is new and the heart is run at an average speed (setting 3) the battery will power the heart for over 40 hours. If the reserve battery is used for under 12 hours and then recharged, it will last for more than 1000 recharge cycles. If it is not recharged until it is fully discharged and the low battery alarm sounds, it will last for fewer than 200 recharge cycles. We recommend the following: (1) Use the Reserve Battery for less than 12 hours each night and plug it in to recharge each morning after switching over to the portable gray Li-ion batteries. (2) Rotate use of Reserve Batteries by using one of the Reserve Batteries one night and the other reserve battery the following night. Alternating the batteries this way assures that they will both be freshly charged (which is important if there is a power outage at the patient s home) and increases the service life of both batteries. To recharge the reserve battery one must do the following: 1) after attaching a charged battery to the Y-cable, disconnect the reserve battery and plug the gray plug on the end of the 8 foot gray cord into the gray receptacle on the reserve battery pack, and 2) plug the reserve pack into the wall using the black power cord. Page 23 of 29

24 Battery Cable Connected to Charger Power Cord Reserve Lead-Acid Battery and Charger A green light and a yellow light will go on top of the battery charger, visible through the plastic window in the carrying case. When the battery is fully charged (after 8-12 hours), the yellow light will go out and only the green light will glow. This indicates that the battery is fully charged. It may remain connected to the wall plug indefinitely without damage to the battery. We recommend that the wall power cable be unplugged each night when the FlowMaker is connected to the reserve battery. One should unplug the cable both from the wall and from the battery pack. The green light does not indicate that the battery is fully charged unless the gray plug of the six foot long gray cable is plugged into the receptacle on the battery pack. NOTE: If the eight foot long gray cable is plugged into the FlowMaker control system or is not plugged into anything, the green light only indicates that the reserve battery is plugged into the wall. The reserve battery pack must be plugged in correctly to be certain that it is fully charged Page 24 of 29

25 15. CABLES AND CABLE CONNECTORS The control system has two receptacles, a black one for the Jarvik 2000 cable and/or extension cable and a gray one for the Y-cable. The plugs and receptacles are keyed so that they cannot be connected improperly, and are also color coded for ease of use. Receptacle Receptacle Plug Plug Connection from Jarvik 2000 Heart to FlowMaker Controller: The black receptacles on the FlowMaker Controller are located above the housing for the small backup battery. They have double key slots for the black plugs. The extension cord also has double key slots. Connection from FlowMaker Controller to Y-cable or battery: The gray receptacles on the FlowMaker Controller are located below the housing for the small back-up battery. They have a single key slot for the gray plugs of the Y-cable and the battery cable. Note that the single and double keys on the plugs and receptacles are easily visible and must be placed in the proper rotational position for the connectors to go together. Place the plug into the receptacles with slight pressure and gently rotate the plug until the key-way engages. Then push the connector together. The connector should click into place and should not come apart if the cable is tugged (although care should be taken to avoid this). To remove the plug, hold it close to the receptacle and pull. Page 25 of 29

26 CAUTION: Never attempt to disconnect any connector by twisting The connectors are attached and removed by a push pull latch mechanism and not by a screw thread Do not attempt to pull the connector apart by the wire or by the strain relief If you pull on the cable, the connector will remain attached and damage may occur Never force a connector together. If the plug does not go into the receptacle easily, gently rotate it until it is aligned properly. When it is fully engaged, a soft click can be heard. An extension cable between the controller and pump may be used to allow the electrical equipment to be kept at distance. The extension cord includes a retractable coil about a foot long which extends to about six feet. This facilitates domestic activities such as sleeping and showering. The retractable coil is intended to be partially stretched during normal use, but should not be over-stretched or it will not return to its original shape and may become tangled more easily. A loop of cable from the heart should be maintained near this connector to protect the skin from being stretched and injured if the cable becomes caught on something and is accidentally pulled. The cable or connector may break if pulled with more than 15 pounds of force. All external cables should be replaced after 6 months of use for all patients supported with the Jarvik 2000 system. These include: o External Abdominal Cable from Pump to Controller. o The Y-Cable from the Controller to the Li-ion Battery Cable. o The Li-ion Battery Cable from the Y-Cable to the Li-ion Battery Pack. Please make sure that all your external cables are replaced after 6 months of use. If not, please notify the contact person from the Jarvik Heart Team in the hospital, they will provide you with new external cables. Page 26 of 29

27 16. THE Y-CABLE The Y-Cable for the Jarvik 2000 is used to allow battery changes without removing power from the pump. Before unplugging the discharged battery a recharged battery should be plugged into the Y-cable. If the battery cable is unplugged prior to attaching a charged battery to the other end of the Y-cable, the Jarvik 2000 stops, but the natural heart continues to beat. If this occurs, the beeping tone of the alarm will change to a steady tone, indicating that the Jarvik 2000 is stopped. After the used battery is replaced with a fresh one, always remove the discharged battery from the Y-cable. NOTE: If the pump stopped alarm sounds while using the Y-cable it is possible that the Y-cable may have failed. Remove the Y-cable and plug the battery cable directly into the gray receptacle of the FlowMaker Controller. If the pump then runs properly and the alarm no longer sounds, the problem was with the Y-cable. When either of the two types of batteries being used to run the heart are low, the low battery alarm on the FlowMaker Controller will begin to beep. Even after the low battery alarm begins to beep the Jarvik 2000 will continue to run for at least five to ten minutes. There is no immediate need to change the battery the moment the alarm goes on, but you should always change the battery within the next few minutes. Take enough time to change the battery carefully in order to protect the cables and connectors from damage. If the black portable battery is allowed to run longer than 10 minutes after the alarm sounds the battery may be damaged and not last as long in the future. If the gray portable battery is allowed to run for more than five to ten minutes it will shut off completely, and the heart will stop running. It is recommended that the Y-Cable and all other external cables are replaced after 6 months of use. (Please see the Cables and Cable Connectors section of this handbook for additional information). Page 27 of 29

28 General instructions to set up the system: Connect any of the available battery types to either of the female receptacles of the Y-cable using the battery cable previously used. The other receptacle should have the blank plug inserted to seal the receptacle. If the heart is being powered by a battery without a Y-cable, unplug the battery cable from the controller. Connect the male plug of the Y-cable to the controller. Connect the battery cable to the Y-cable. Page 28 of 29

29 Instructions for battery change: Any battery type can be used in combination any other battery type. There is no reason to make the change quickly. Take your time to avoid damaging the cables or connectors. It is safe to leave two batteries connected simultaneously but it is not recommended that you do this for more than a few minutes. Leave two batteries connected for only as long as required to change batteries. Page 29 of 29