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user guide | Users Manual | 2.81 MiB | November 11 2015 | |||
| 1 | Attestation Statements | November 11 2015 | ||||||
| 1 | Attestation Statements | November 11 2015 | ||||||
| 1 | External Photos | November 11 2015 | ||||||
| 1 | Internal Photos | November 11 2015 | ||||||
| 1 | Internal Photos | November 11 2015 | ||||||
| 1 | ID Label/Location Info | November 11 2015 | ||||||
| 1 | Cover Letter(s) | November 11 2015 | ||||||
| 1 | RF Exposure Info | November 11 2015 | ||||||
| 1 | RF Exposure Info | November 11 2015 | ||||||
| 1 | RF Exposure Info | November 11 2015 | ||||||
| 1 | RF Exposure Info | November 11 2015 | ||||||
| 1 | Test Report | November 11 2015 | ||||||
| 1 | Test Setup Photos | November 11 2015 | ||||||
| 1 | Test Report | November 11 2015 | ||||||
| 1 | Test Report | November 11 2015 |
| 1 | user guide | Users Manual | 2.81 MiB | November 11 2015 |
HeartAssist 5 VAD System Patient User's Manual For use with Controller Model: CTL002 L00088-01 Rev R 12/2014 The HeartAssist 5 VAD is a miniaturized ventricular assist technology co-developed with Dr. Michael E. DeBakey, Dr. George P. Noon and the National Aeronautics and Space Administration (NASA). Federal (USA) law limits the sale and use of HeartAssist 5 VAD to investigational use only. HeartAssist 5 and HeartAttendant are registered trademarks of ReliantHeart Inc. 0086 CE marked since November 2013 Copyright 2001 2014 by ReliantHeart as an unpublished work. All rights reserved. ii HeartAssist 5 VAD System Patient User's Manual Customer support Use the contact information below to reach ReliantHeart. International ReliantHeart (Distributor) Erfstraat 10A 5405 BE Uden, The Netherlands Phone +31 413 245 107 Fax +31 413 270 504 MedPass International Limited (Authorized Representative) Windsor House Bretforton Evesham Worcs, WR117JJ United Kingdom Emergency technical and clinical support for medical professionals
(24/7 Urgent Support)
+44 132-386-2836 Emergency help for patients Contact your health care provider. (See page 1-2.) Non-emergency technical and clinical support support@reliantheart.com United States ReliantHeart (Manufacturer) 8965 Interchange Drive Houston, TX 77054 Phone: 713-592-0913 Fax: 713-665-0963 Emergency technical and clinical support for medical professionals 877-332-2539 Emergency help for patients Call 911, or contact your health care provider. (See page 1-2.) Non-emergency technical and clinical support support@reliantheart.com ReliantHeart Confidential Patient and Heath Care Provider Use iii iv HeartAssist 5 VAD System Patient User's Manual Contents Figures ............................................................................................................................................. x Tables.............................................................................................................................................. xii Warnings ........................................................................................................................................ xiii Cautions .......................................................................................................................................... xv Chapter 1 Emergency Information Introduction ................................................................................................................................... 1-2 Support team phone numbers quick reference ............................................................................. 1-2 Conditions for calling emergency assistance ................................................................................ 1-2 Call 911 ............................................................................................................................ 1-2 Call your doctor ................................................................................................................ 1-3 Chapter 2 About This Manual Introduction ................................................................................................................................... 2-2 Purpose of this manual ................................................................................................................. 2-2 Scope of this manual ..................................................................................................................... 2-2 Intended audience ......................................................................................................................... 2-2 How to use this manual ................................................................................................................. 2-2 Text conventions .............................................................................................................. 2-3 Tips, notes, cautions, and warnings ................................................................................. 2-3 Description of chapters ................................................................................................................. 2-4 Chapter 3 Description of the HeartAssist 5 VAD System Introduction ................................................................................................................................... 3-2 Indications and contraindications for use ...................................................................................... 3-2 Potential complications ................................................................................................................. 3-3 Maintenance .................................................................................................................................. 3-3 System components ...................................................................................................................... 3-3 Implantable components .................................................................................................. 3-4 Wearable components ..................................................................................................... 3-5 Accessories ................................................................................................................................... 3-7 Patient accessories .......................................................................................................... 3-7 Hospital accessories ........................................................................................................ 3-8 Symbols used in labeling .............................................................................................................. 3-8 Documentation ............................................................................................................................ 3-11 Chapter 4 Getting Started with Your HeartAssist 5 VAD System Introduction ................................................................................................................................... 4-2 General considerations ................................................................................................................. 4-2 Controller ....................................................................................................................................... 4-2 ReliantHeart Inc. Confidential Patient and Heath Care Provider Use Contents v Overview .......................................................................................................................... 4-3 Controller display ............................................................................................................. 4-3 Controller sounds ............................................................................................................. 4-4 Controller messages and alarms ..................................................................................... 4-4 Battery indicators ............................................................................................................. 4-5 Flow sensor ...................................................................................................................... 4-5 Wireless radio antenna .................................................................................................... 4-5 Automatic fail-safe mode ................................................................................................. 4-6 VAD restart algorithm ....................................................................................................... 4-6 Controller replacement ..................................................................................................... 4-7 Controller safety check .................................................................................................. 4-14 Battery pockets ........................................................................................................................... 4-15 VADPAK ...................................................................................................................................... 4-16 VADPAK components .................................................................................................... 4-16 Setting up the VADPAK Insert ....................................................................................... 4-16 Connecting to external power ........................................................................................ 4-21 Power supply ............................................................................................................................... 4-22 Batteries ......................................................................................................................... 4-22 LVAD Battery Charger ................................................................................................... 4-28 Independent Power Supply ............................................................................................ 4-31 Connecting the Independent Power Supply to the Controller ........................................ 4-32 Chapter 5 Everyday Use and Self Care Introduction ................................................................................................................................... 5-2 Daily status checks ....................................................................................................................... 5-2 Upon waking .................................................................................................................... 5-2 Before sleeping ................................................................................................................ 5-2 Daily operation .............................................................................................................................. 5-3 Tethered operation ........................................................................................................... 5-3 Untethered operation ....................................................................................................... 5-3 Switching from tethered to untethered operation ............................................................. 5-4 Switching from untethered to tethered operation ............................................................. 5-5 Leaving the home ............................................................................................................. 5-6 Showering with the VADPAK Insert and shower bag ...................................................... 5-6 Activity restrictions ........................................................................................................... 5-8 Self care at home .......................................................................................................................... 5-9 Caring for the exit site ...................................................................................................... 5-9 Caring for the percutaneous cable ................................................................................. 5-10 Caring for the VADPAK .................................................................................................. 5-10 Taking medications ........................................................................................................ 5-10 Emergencies ............................................................................................................................... 5-11 Local emergency services ............................................................................................. 5-11 vi Contents HeartAssist 5 VAD System Patient User's Manual CPR and defibrillation .................................................................................................... 5-11 Power outages ............................................................................................................... 5-11 Chapter 6 Equipment Care and Maintenance Introduction ................................................................................................................................... 6-2 All HeartAssist 5 VAD System components ............................................................................... 6-2 Environmental conditions ................................................................................................. 6-2 Contact with liquids .......................................................................................................... 6-3 Electromagnetic disturbances .......................................................................................... 6-3 Service ............................................................................................................................. 6-4 Controller ....................................................................................................................................... 6-4 LVAD Battery Charger .................................................................................................................. 6-4 Independent Power Supply ........................................................................................................... 6-5 Chapter 7 The Pediatric Patient on HeartAssist 5 LBSA VAD Support Introduction ................................................................................................................................... 7-2 Implant surgery ............................................................................................................................. 7-2 System description ........................................................................................................................ 7-2 Environmental conditions .............................................................................................................. 7-2 Temperature ..................................................................................................................... 7-2 Contact with liquids .......................................................................................................... 7-3 Electromagnetic disturbances .......................................................................................... 7-3 Electrostatic discharge ..................................................................................................... 7-4 Operating the HeartAssist 5 LBSA VAD system ........................................................................ 7-4 Batteries ........................................................................................................................... 7-4 VADPAK ........................................................................................................................... 7-4 Percutaneous cable ......................................................................................................... 7-5 Daily operation for the pediatric patient ........................................................................................ 7-5 Leaving the home ............................................................................................................. 7-5 Returning to school .......................................................................................................... 7-5 Activities ........................................................................................................................... 7-6 Travel ............................................................................................................................... 7-6 Sleeping ........................................................................................................................... 7-6 Showering and cleansing ................................................................................................. 7-6 Emergencies ................................................................................................................................. 7-6 Local emergency services ............................................................................................... 7-6 CPR and defibrillation ...................................................................................................... 7-7 Power outages ................................................................................................................. 7-7 Prevention ........................................................................................................................ 7-7 Appendix A Troubleshooting Emergencies ................................................................................................................................. A-2 ReliantHeart Inc. Confidential Patient and Heath Care Provider Use Contents vii Controller troubleshooting ............................................................................................................. A-3 Non-VAD related troubleshooting ................................................................................................. A-6 Appendix B Controller Messages and Alarms Standard message screens .......................................................................................................... B-2 Emergency alarms ........................................................................................................................ B-4 Emergency alarm 1: PUMP STOPPED ........................................................................... B-4 Emergency alarm 2: BOTH BATTERIES DISCONNECTED ........................................... B-5 Emergency alarm 3: VAD DISCONNECTED .................................................................. B-5 Diagnostic alarms .......................................................................................................................... B-6 Diagnostic alarm 1: EXCESS CURRENT ........................................................................ B-6 Diagnostic alarm 2: REDUCED FLOW RATE ................................................................. B-7 Diagnostic alarm 3: REDUCED MOTOR SPEED ............................................................ B-7 Diagnostic alarm 4: PUMP RESTARTING ...................................................................... B-7 Diagnostic alarm 5: BATTERY 1 DISCONNECTED ........................................................ B-8 Diagnostic alarm 6: BATTERY 1 DISCHARGED ............................................................ B-8 Diagnostic alarm 7: BATTERY 1 EXPIRED ..................................................................... B-9 Diagnostic alarm 8: BATTERY 2 DISCONNECTED ........................................................ B-9 Diagnostic alarm 9: BATTERY 2 DISCHARGED ..........................................................B-10 Diagnostic alarm 10: BATTERY 2 EXPIRED .................................................................B-10 Controller failure alarms ..............................................................................................................B-11 Controller failure alarm 1: fail-safe alarm .......................................................................B-11 Controller failure alarm 2: Controller failure alarm .........................................................B-12 Appendix C System Specifications Introduction .................................................................................................................................. C-2 HeartAssist 5 VAD specifications .............................................................................................. C-2 Controller specifications ............................................................................................................... C-3 General specifications ..................................................................................................... C-3 Interface features ............................................................................................................ C-3 Safety features ................................................................................................................ C-3 Wireless antenna specifications ................................................................................................... C-4 HeartAttendant specifications .................................................................................................... C-4 General specifications ..................................................................................................... C-4 Safety features ................................................................................................................ C-4 Electrical specifications ................................................................................................... C-4 Replacement and accessory part list (fuses) .................................................................. C-5 VADPAK and VADPAK Insert specifications ............................................................................... C-5 Independent Power Supply specifications ................................................................................... C-5 General specifications ..................................................................................................... C-5 Safety features ................................................................................................................ C-6 Electrical specifications ................................................................................................... C-6 viii Contents HeartAssist 5 VAD System Patient User's Manual Lithium ion battery specifications ................................................................................................. C-6 General specifications ..................................................................................................... C-6 Safety features ................................................................................................................ C-6 Electrical specifications ................................................................................................... C-6 LVAD Battery Charger specifications ........................................................................................... C-7 General specifications ..................................................................................................... C-7 Electrical specifications ................................................................................................... C-7 Connecter cables, power cords, and fuses .................................................................................. C-7 Essential performance of the HeartAssist 5 VAD ...................................................................... C-8 Appendix D Manufacturer Guidance for Environmental Conditions Introduction .................................................................................................................................. D-2 Electromagnetic emissions .......................................................................................................... D-2 Electromagnetic immunity ............................................................................................................ D-2 Recommended separation distance between portable and mobile RF communications equipment and the Controller, HeartAttendant, battery pockets, Independent Power Supply, and batteries ............................................................................................................. D-5 Requirements applicable to ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of their operation (60601-1-2, 5.2.2.5) .................................................................................. D-6 Requirements applicable to ME EQUIPMENT and ME SYSTEMS that include RF transmitters (60601-1-2, 5.2.2.6) .............................................................................. D-7 FCC statements ........................................................................................................................... D-8 Statement according to FCC part 15.19 ......................................................................... D-8 Statement according to FCC part 15.21 ......................................................................... D-8 Statement according to FCC part 15.105 ....................................................................... D-8 R&TTE Declaration of Conformity .............................................................................................. D-10 Index ReliantHeart Inc. Confidential Patient and Heath Care Provider Use Contents ix Figures Figure 3-1. Figure 4-1. Figure 4-2. Figure 4-3. Figure 4-4. Figure 4-5. Figure 4-6. Figure 4-7. Figure 4-8. Figure 4-9. Figure 4-10. Figure 4-11. Figure 4-12. Figure 4-13. Figure 4-14. Figure 4-15. Figure 4-16. Figure 4-17. Figure 4-18. Figure 4-19. Figure 4-20. Figure 4-21. Figure 4-22. Figure 4-23. Figure 4-24. Figure 4-25. Figure 4-26. Figure 4-27. Figure 4-28. Figure 4-29. Figure 4-30. Figure 4-31. Figure 4-32. Figure 4-33. Figure 4-34. Figure 4-35. Figure 4-36. The HeartAssist 5 VAD System ................................................................. 3-2 Controller ...................................................................................................... 4-3 Controller front panel .................................................................................... 4-4 Backup equipment for replacing the Controller ............................................ 4-7 Removing the VADPAK Insert from the VADPAK ........................................ 4-8 Arranging the components for easy access ................................................. 4-8 Unscrewing the defibrillation cover ............................................................... 4-9 Disconnecting one battery pocket from the Controller ................................. 4-9 Connecting the first battery pocket to the backup Controller ..................... 4-10 Disconnecting the percutaneous cable ...................................................... 4-10 Aligning the driveline cable to the backup Controller ................................. 4-10 Disconnecting the second battery pocket from the Controller.................... 4-11 Connecting the second battery pocket to the backup Controller ............... 4-12 Removing the SIM card cover with the ReliantHeart screwdriver .............. 4-12 SIM card covers removed from both Controllers ........................................ 4-13 Removing the SIM card from the Controller ............................................... 4-13 Inserting the SIM card into the backup Controller ...................................... 4-13 Replacing the SIM card cover .................................................................... 4-14 Battery pocket ............................................................................................. 4-15 VADPAK ..................................................................................................... 4-16 VADPAK Insert ........................................................................................... 4-17 Securing the battery pockets in the VADPAK Insert .................................. 4-17 Securing the Controller into the VADPAK Insert with the Controller display facing upward ................................................................................. 4-18 Securing the battery connectors in the VADPAK Insert ............................. 4-18 Placing the VADPAK Insert in the VADPAK............................................... 4-19 Viewing the Controller in the clear window of the VADPAK ....................... 4-19 Routing the driveline cable in the VADPAK................................................ 4-20 Zipping up the VADPAK completely ........................................................... 4-20 Exposing the battery pocket external power connector ............................. 4-21 Aligning the arrow on the power source connector with the square on the battery pocket external power connector ............................................. 4-21 Routing the cables in the VADPAK ............................................................ 4-22 HeartAssist 5 VAD battery ....................................................................... 4-23 Battery charge level LED indicators ........................................................... 4-23 Aligning the arrow on the battery pocket connector with the square on the Controller connector ........................................................................ 4-24 Batteries connected to the Controller ......................................................... 4-25 Removing the battery from the battery pocket ........................................... 4-27 LVAD Battery Charger ................................................................................ 4-29 x Figures HeartAssist 5 VAD System Patient User's Manual Figure 4-37. Figure 4-38. Figure 5-1. Figure 5-2. Figure 5-3. Figure 5-4. Figure 5-5. Figure 6-1. Figure B-1. Figure B-2. Figure B-3. Figure B-4. Figure B-5. Figure B-6. Figure B-7. Figure B-8. Figure B-9. Figure B-10. Figure B-11. Figure B-12. Figure B-13. Figure B-14. Figure B-15. Figure B-16. Figure B-17. Figure B-18. Figure B-19. Figure B-20. Figure B-21. Figure B-22. Independent Power Supply ........................................................................ 4-31 Independent Power Supply connection diagram ........................................ 4-32 Standard message screen 1 display on the Controller front panel when using external power ........................................................................... 5-2 Standard message screen 1 display on the Controller front panel when using battery power ............................................................................ 5-4 Properly inserting the Controller, battery pockets, batteries, and cables in the VADPAK Insert into the shower bag ....................................... 5-7 Securing the percutaneous cable to the side of the shower bag ................. 5-7 Properly closing and securing the lid of the shower bag .............................. 5-8 MRI warning and safety seal ........................................................................ 6-3 Standard message screen 1: battery status ................................................. B-2 Standard message screen 2: current VAD parameters ............................... B-2 Standard message screen 3: wireless antenna status ................................. B-3 Standard message screen 4: flow probe received amplitude ...................... B-3 Standard message screen 5: flow sensor status ......................................... B-3 Standard message screen 6: battery capacity ............................................. B-3 Standard message screen 7: not used ......................................................... B-4 Emergency alarm 1: PUMP STOPPED ........................................................ B-4 Emergency alarm 2: BOTH BATTERIES DISCONNECTED ....................... B-5 Emergency alarm 3: VAD DISCONNECTED ............................................... B-5 Diagnostic alarm 1: EXCESS CURRENT .................................................... B-6 Diagnostic alarm 2: REDUCED FLOW RATE .............................................. B-7 Diagnostic alarm 3: REDUCED MOTOR SPEED ........................................ B-7 Diagnostic alarm 4: PUMP RESTARTING ................................................... B-8 Diagnostic alarm 5: BATTERY 1 DISCONNECTED .................................... B-8 Diagnostic alarm 6: BATTERY 1 DISCHARGED ......................................... B-9 Diagnostic alarm 7: BATTERY 1 EXPIRED ................................................. B-9 Diagnostic alarm 8: BATTERY 2 DISCONNECTED ..................................B-10 Diagnostic alarm 9: BATTERY 2 DISCHARGED .......................................B-10 Diagnostic alarm 10: BATTERY 2 EXPIRED .............................................B-11 Controller failure alarm 1: fail-safe alarm (display frozen) ..........................B-11 Controller failure alarm 2: (no display) .......................................................B-12 ReliantHeart Inc. Confidential Patient and Heath Care Provider Use Figures xi Tables Table 1-1. Table 2-1. Table 2-2. Table 3-1. Table 3-2. Table 3-3. Table 3-4. Table 3-5. Table 3-6. Table 4-1. Table 4-2. Table 4-3. Table 5-1. Table 5-2. Table 5-3. Table A-1. Table A-2. Table C-1. Table C-2. Table C-3. Table C-4. Table C-5. Table C-6. Table C-7. Table C-8. Table C-9. Table C-10. Table C-11. Table C-12. Table D-1. Support team phone numbers ...................................................................... 1-2 Text conventions used in this manual .......................................................... 2-3 The HeartAssist 5 VAD System Patient Users Manual chapter descriptions .................................................................................................. 2-4 Implantable components .............................................................................. 3-4 Wearable components.................................................................................. 3-5 Patient accessories ...................................................................................... 3-7 Hospital accessories ..................................................................................... 3-8 Product labeling symbols ............................................................................. 3-8 HeartAssist 5 VAD System documentation set ....................................... 3-11 Battery charge level LED indicators ........................................................... 4-24 Controller battery indicator descriptions ..................................................... 4-26 LVAD Battery Charger status lights description ......................................... 4-30 Prohibited activities ....................................................................................... 5-8 Restricted activities ....................................................................................... 5-9 Permitted activities ....................................................................................... 5-9 Troubleshooting guide for Controller alarms ................................................ A-3 Troubleshooting guide for non-VAD issues .................................................. A-6 HeartAssist 5 VAD general specifications ................................................ C-2 Controller general specifications ................................................................. C-3 HeartAttendant general specifications ...................................................... C-4 HeartAttendant electrical specifications .................................................... C-4 HeartAttendant part list ............................................................................. C-5 VADPAK specifications ............................................................................... C-5 Independent Power Supply general specifications ..................................... C-5 Independent Power Supply electrical specifications ................................... C-6 Lithium ion battery general specifications ................................................... C-6 Lithium ion battery electrical specifications ................................................. C-6 LVAD Battery Charger general specifications ............................................. C-7 LVAD Battery Charger electrical specifications ........................................... C-7 Electromagnetic emissions guidance and manufacturers declaration for all ME equipment and ME systems ........................................................ D-2 Electromagnetic immunity guidance and manufacturers declaration for all ME equipment and ME systems ........................................................ D-2
< Radio Frequency Susceptibility (Radiated and Conducted) .................... D-3 Table D-3. and Electrostatic Discharge > ..................................................................... D-3 Table D-4. Table D-2. Electromagnetic immunity guidance and manufacturers declaration for all life supporting ME equipment and ME systems ................................ D-4 Recommended separation distance between portable and mobile RF communications equipment and the life-supporting ME equipment and ME systems .......................................................................................... D-5 HeartAssist 5 VAD System Patient User's Manual Table D-5. xii Tables Warnings General warnings The following warnings do not appear elsewhere in this manual. Warnings indicate possible bodily injury or death. Do not disconnect the HeartAssist 5 VAD (VAD) from the Controller. The VAD will stop. The Controller must be reconnected as quickly as possible to resume VAD function. The Controllers internal capacitors only run the CPU and alarms for approximately three minutes. They do not run the VAD. If both of the batteries are disconnected or depleted, the VAD stops. Do not use the Independent Power Supply with ventricular assist devices (VADs) other than the HeartAssist 5 VAD System. The Independent Power Supply should not be used in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. The VAD should not be used adjacent to other equipment or in a stacked configuration with other equipment. The normal operation of the VAD must be verified when used in these configurations. Avoid unnecessary pulling or moving of the external portion of the percutaneous lead, especially as the exit site is healing. Pulling on or moving the lead could prolong the healing process or disrupt an already healed exit site. Disruption of the percutaneous lead exit site increases the patient's risk of acquiring a serious infection. Avoid prolonged direct contact between the Controller and battery pockets and your skin. The Controller and batteries emit heat that could potentially cause harm if left in direct contact with skin. Limit direct contact with skin to less than one minute. Always place the Controller (with battery) in the VADPAK Insert to promote proper cooling of the Controller and to eliminate potential bodily harm. Exercise diligent care throughout the course of VAD support to prevent infection and sepsis. Systemic infections and localized infection of the percutaneous lead exit site can occur with use of this device. Infection can contribute to patient morbidity and death. Be cautious in the presence of young children as they may not understand the life supporting nature of the system and could damage cables, connectors, or other system components. Keep pets and pests away from all HeartAssist 5 VAD System components as they could damage cables, connectors, or other system components. ReliantHeart Inc. Confidential Patient and Heath Care Provider Use Warnings xiii List of warnings The following warnings appear sequentially in this manual on the pages indicated. Read this entire manual before handling the VAD without supervision. Do not store or use the Independent Power Supply near water or any liquid
(for example, in the bathroom or kitchen) due to the risk of electrical shock. .......... 2-4 Only use the power cables supplied by ReliantHeart. .............................................. 4-2 Plug this equipment into grounded outlets only to reduce the risk of shock. If the power outlets are not grounded, an electrician must install grounded outlets before you can use this equipment outside of the hospital. ......................... 4-2 Only attempt to manually restart the VAD one time. If the VAD does not successfully restart, immediately begin the procedure detailed in the next section, Controller replacement. ............................................................................ 4-7 You must periodically (every two to three hours) visually inspect the front panel of the Controller to verify battery status in case of a diagnostic audible alarm failure. ........................................................................................................... 4-26 Only remove one battery at a time from the battery pockets. Removing both batteries simultaneously causes the VAD to stop (unless you are in tethered mode). The batteries must be reconnected as quickly as possible to resume VAD function. .......................................................................................................... 4-27 Do not store or use the Independent Power Supply near water or any liquid
(for example, in the bathroom or kitchen) due to the risk of electrical shock. ........ 4-31 Use the Independent Power Supply only with a properly grounded plug. To reduce the risk of electrical shock, plug this equipment into grounded outlets only. If your power outlets are not grounded, an electrician must install grounded outlets before you can use this equipment outside of the hospital. ....... 4-32 Only use batteries supplied by ReliantHeart. ........................................................... 5-3 Only remove one battery at a time from the battery pockets. Removing both batteries simultaneously causes the VAD to stop (unless you are in tethered mode). The batteries must be reconnected as quickly as possible to resume VAD function. ............................................................................................................ 5-4 If a power failure is expected to last for an extended period of time, take the Independent Power Supply, the LVAD Battery Charger, and all batteries to the nearest location with suitable mains power. ....................................................... 5-5 Do not shower with the VAD connected to the Independent Power Supply (in tethered mode). Showering in untethered mode reduces the risk of electrical shock. ....................................................................................................................... 5-6 Keep all liquids away from equipment to avoid accidental spills. Do not put any part of this equipment under water or in other liquids. Contact with liquids increases the risk of electrical shock and of damage to the equipment. .................. 6-3 Do not subject patients implanted with the VAD to magnetic resonance imaging (MRI). The VAD contains ferromagnetic components, and MRI can cause device failure or patient injury. ....................................................................... 6-3 Do not modify this equipment. No modification of this equipment is allowed. ......... 6-4 Do not open the back cover of any ReliantHeart device. ......................................... 6-4 You must always have extra batteries, a backup battery pocket, and a backup Controller. .................................................................................................... A-7 xiv Warnings HeartAssist 5 VAD System Patient User's Manual Cautions General cautions The following cautions do not appear elsewhere in this manual. Cautions indicate possible data loss or equipment damage. Federal law restricts this device to sale or to use by or on the order of a physician or properly licensed practitioner. Implantable parts of this system must not be reused. Do not drop the LVAD Battery Charger, Independent Power Supply, batteries, or the Controller on any hard surface. Dropping these components might damage internal parts causing the device to malfunction. Do not expose the LVAD Battery Charger, Independent Power Supply to moisture. Do not store the HeartAssist 5 VAD System in environments where temperatures are less than 20 C (4 F) or greater than 55 C (131 F). Do not store or leave batteries in hot or cold areas (e.g., car trunks, dashboards, window sills, and so forth). These temperatures can damage the battery. Do not attempt to make any changes to system software or to use the device as a laptop computer. Any modification of, or attempt to modify, the operating system software could result in rendering this device nonfunctional for its intended use. Disconnect the Controller from the Independent Power Supply before unplugging the Independent Power Supply from the power source. The percutaneous cable from the patient to the Controller must be handled with care to prevent damage. All connectors must be handled with care and kept free of liquid, dust, and debris. Clean the LVAD Battery Charger, Independent Power Supply by first disconnecting the equipment from the power source and then wiping it with a damp cloth. Complete the cleaning process by wiping the equipment with isopropanol alcohol to remove contaminants. Do not invert the cabinet of the LVAD Battery Charger while installing batteries. A spare Controller, a spare battery pocket, and additional batteries must be accessible to the patient at all times. When connecting the Controller to the Independent Power Supply, ensure that mains
(AC) power is available or that fully charged batteries are installed in the battery pockets. Do not obstruct the fan on the back of the LVAD Battery Charger. Obstructing the fan can prevent the batteries from charging properly or cause the LVAD Battery Charger to overheat. Using expired or defective batteries can result in reduced operating time or abrupt loss of VAD function. Do not set alarm thresholds to extreme values that can render the alarm system useless. ReliantHeart Inc. Confidential Patient and Heath Care Provider Use Cautions xv Do not dispose of any ReliantHeart equipment. Return all equipment to your support team for proper return to ReliantHeart. Do not use a battery suspected to be malfunctioning. In the event of a possible battery failure, please remove the faulty battery from battery pocket or charger and replace with a working battery. Contact ReliantHeart if a battery error is suspected. List of cautions The following cautions appear sequentially in this manual on the pages indicated. Connecting batteries other than as described can result in permanent damage to the unit. ................................................................................................... 2-4 Ensure that the mains (AC) input voltage is appropriate for the local power source. Do not use extension cords. ........................................................................ 4-2 Do not block fans or ventilation holes of the equipment. Blocking these openings can cause heat to build up inside and damage the equipment. ............... 4-2 Align the driveline connector and Controller connector properly. Forcing the connectors with improper alignment can damage the equipment. Do not twist a connector plug while inserting it after the connectors are aligned. ..................... 4-11 Align all connectors properly. Forcing connectors without proper alignment can damage the equipment. Do not try to force a power source connector into the battery pocket external power connector. When removing a cable, hold the connector, and pull it out. Do not twist the connectors while inserting them or removing them after the connectors are aligned. ...................................... 4-25 Do not handle batteries by the connector pins. A strong static discharge can cause the charge level indicator to temporarily malfunction. If the charge level indictor ceases to function, place the battery into a ReliantHeart charger, and recharge the battery. ......................................................................... 4-28 Even when they are connected to an external power source (such as the Independent Power Supply), the batteries located inside the battery pockets drain and lose charge over time. Verify that the two batteries in the battery pockets have sufficient charge levels prior to disconnecting the system from an external power source. ...................................................................................... 4-28 Obtain replacement batteries from ReliantHeart after the battery capacity indicates less than 6,000 milliamp hours. Only use batteries supplied by Reliant Heart. .......................................................................................................... 4-28 Connection other than indicated can result in permanent damage to the LVAD Battery Charger. ........................................................................................... 4-30 Avoid placing or operating the LVAD Battery Charger in areas or near appliances that expose it to temperatures outside of the operating range of the device, which is 0 C (32 F) to 50 C (122 F). ............................................... 4-30 The Independent Power Supply contains no user-serviceable parts. Do not open the back cover of the Independent Power Supply. Only qualified ReliantHeart personnel can service this equipment. If service is required, contact your support team. ..................................................................................... 4-31 Avoid placing or operating the Independent Power Supply in areas or near appliances that expose it to temperatures outside the operating range of the device, which is 0 C (32 F) to 40 C (104 F) or where relative humidity is noncondensing, less than 10% Rh or greater than 75% Rh. ................................. 4-31 Do not trip over the power cord. Instruct persons in the area to prevent tripping. ................................................................................................................... 4-31 xvi Cautions HeartAssist 5 VAD System Patient User's Manual Contact your support team if any of the Controller alarms are not working. Every two three hours when you are awake (whether you are attached to the Independent Power Supply or not), check the battery status on the Controller front panel. ............................................................................................... 5-2 You can damage the connectors if you force them without proper alignment. After the connectors are aligned, do not twist the power source connector while connecting it. ................................................................................................... 5-5 Ensure that batteries that are not being used in the battery pockets are always charging in the LVAD Battery Charger while you are in the tethered mode of operation. .................................................................................................... 5-5 Do not submerge the Controller in liquid. Submerging the Controller in liquid might damage internal parts, causing the device to malfunction. Showers and washing are permitted when the clinician approves wound site readiness. During showers, you must use the shower bag. Do not expose the Controller to moisture. ............................................................................................................... 5-6 Do not submerge batteries in liquid or expose them to heat or moisture. Submerging the batteries in liquid or exposing them to heat might cause them to malfunction. During showers, you must use the shower bag to prevent exposure to moisture. .................................................................................. 5-6 Ensure that the VADPAK Insert is properly encased in the provided shower bag before showering. .............................................................................................. 5-6 Do not use the VADPAK Insert and Controller in the shower bag longer than 30 minutes because the Controller requires air circulation for proper cooling. ........ 5-8 Position the shower bag so that it does not tip or drop. Do not allow the shower bag to sit in liquid. ........................................................................................ 5-8 The system has not been tested with each possible brand of device, and the possibility of electromagnetic disturbances exists. If you experience unexpected changes in the speed of the VAD, investigate potential sources of electromagnetic disturbances (such as cellular phones, radio transmitters, or microwave ovens) within a few feet. If you discover disturbances, move away from the potential source, and determine if the VAD operation returns to normal. If it does not return to normal, contact your support team. ..................... 6-3 Do not service this equipment yourself. Only qualified personnel can service this equipment. If service is required, contact your support team. ........................... 6-4 Do not drop the Controller on any hard surface. Dropping the Controller can damage internal parts causing the device to malfunction. ....................................... 6-4 Do not attempt to wipe liquid from the inside of the LVAD Battery Charger battery bays as this action might bend or otherwise damage the connector pins. .......................................................................................................................... 6-5 Do not operate the Controller where temperatures are less than 10 C (14 F) or greater than 40 C (104 F) or where the relative humidity is noncondensing, <10% Rh or >75% Rh. ................................................................... 7-2 The batteries, Controller, battery pockets, VADPAK, and VADPAK Insert must not be exposed to moisture or heat. ................................................................ 7-3 Never spray water or detergent directly onto the Controller. Always apply water or detergent to a soft cloth, wring it out until just slightly damp, and wipe the Controller. ................................................................................................... A-6 You can damage the connectors if you force them without proper alignment. Do not twist the connectors while inserting them after the connectors are aligned. ..................................................................................................................... A-8 ReliantHeart Inc. Confidential Patient and Heath Care Provider Use Cautions xvii The HeartAttendant is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the HeartAttendant can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HeartAttendant as recommended in Table D-4, according to the maximum output power of the communications equipment. .................................................................................... D-6 Use of equipment and supplies other than those specified in this manual or sold by ReliantHeart for replacement parts could affect the electromagnetic compatibility of the HeartAssist 5 VAD with other devices, resulting in potential interference between the HeartAssist 5 VAD and other devices. .......... D-6 The HeartAttendant must be kept at least one foot away from electrical appliances (such as kitchen appliances). ................................................................ D-6 The HeartAssist 5 VAD System requires special precautions regarding electromagnetic compatibility (EMC), and you must install it and put it into service according to the EMC information provided in this appendix. .................... D-8 Portable and mobile RF communications equipment can affect the HeartAssist 5 VAD System. .................................................................................. D-8 Radio frequency radiation exposure information: For body worn operation, this phone has been tested and meets the FCC RF exposure guidelines when used with the ReliantHeart accessories supplied or designated for this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. ................................................................................................ D-9 xviii Cautions HeartAssist 5 VAD System Patient User's Manual Chapter 1 Emergency Information In this chapter Introduction ................................................................................................................................... 1-2 Support team phone numbers quick reference ............................................................................. 1-2 Conditions for calling emergency assistance ................................................................................ 1-2 Call 911 ............................................................................................................................ 1-2 Call your doctor ................................................................................................................ 1-3 ReliantHeart Confidential Patient and Heath Care Provider Use 11 Introduction This chapter provides a quick reference of your support teams contact information and examples of conditions for calling your doctor or emergency assistance. Read this entire manual before handling the VAD without supervision. Support team phone numbers quick reference Keep a record of your support teams contact information in Table 1-1. To reach ReliantHeart, see Customer support on page iii. Support team phone numbers Table 1-1. Title Emergency assistance Cardiologist Cardiothoracic surgeon Nurse Technical assistance Name Phone Number You should always have access to someone trained in the use of and troubleshooting for the HeartAssist 5 VAD System. Your medical care should be monitored by a qualified doctor or medical staff trained in the operation of the HeartAssist 5 VAD System. The name and phone number of this person, your medical doctor, and heart surgeon are listed above. ReliantHeart recommends that patients who have a limited ability to care for themselves or communicate clearly have a trained companion available. Conditions for calling emergency assistance Use the following guidelines to determine whether to call for emergency help. Your physicians instructions supersede these guidelines. Always follow your physician's orders regarding your care. Call 911 Call 911 or your local emergency number when any of the following symptoms occur:
Loss of consciousness Seizures or convulsions Inability to move or speak Sudden collapse 12 HeartAssist 5 VAD System Patient User's Manual Call your doctor Call your doctor immediately if you have any of the following symptoms:
Numbness, tingling or weakness Pain Redness, swelling, or drainage at the exit site of the percutaneous cable Blurred vision Speech problems Shortness of breath Dizziness Temperature higher than 38 C (100.4 F) Unusual bleeding Unusual bruising ReliantHeart Confidential Patient and Heath Care Provider Use 13 14 HeartAssist 5 VAD System Patient User's Manual Chapter 2 About This Manual In this chapter Introduction ................................................................................................................................... 2-2 Purpose of this manual ................................................................................................................. 2-2 Scope of this manual ..................................................................................................................... 2-2 Intended audience ......................................................................................................................... 2-2 How to use this manual ................................................................................................................. 2-2 Text conventions .............................................................................................................. 2-3 Tips, notes, cautions, and warnings ................................................................................. 2-3 Description of chapters ................................................................................................................. 2-4 ReliantHeart Confidential Patient and Heath Care Provider Use 21 Introduction This manual is intended to supplement formal training provided by your clinician and VAD support team. The VAD should only be operated and monitored by properly trained personnel. Adjustment, maintenance, and repair of this equipment should only be carried out by qualified personnel. Use this manual as a reference after leaving the hospital. Purpose of this manual The purpose of the HeartAssist 5 VAD System Patient Users Manual is to serve as a guide for the HeartAssist 5 VAD System for the patient and patients caregiver. Scope of this manual This manual includes information on operating the HeartAssist 5 VAD System, including the Controller, VADPAK, VADPAK Insert, LVAD Battery Charger, Independent Power Supply, and other components. Intended audience This manual is intended for the HeartAssist 5 VAD System patients and their caregivers. Medical personnel should refer to the HeartAssist 5 VAD System Operators Manual. How to use this manual This manual contains features to assist the reader in finding and comprehending information. These features include a table of contents, a list of figures, a list of tables, an index, chapter-level tables of content, chapter-level numbering, headings and subheadings in the body text, and running headers above the body text that indicate your location in the manual. This manual uses certain conventions to enhance usability. A description of each of these conventions follows in Table 2-1. 22 HeartAssist 5 VAD System Patient User's Manual Text conventions Table 2-1 explains the conventions used in the text of this document. Table 2-1. Text conventions used in this manual Format Boldface Boldface Italic Blue, 10-point text and blue, 10-point initial capped text Meaning The text on the equipment display appears exactly as written in the manual. The emphasized words are particularly important. The formatted text is a file format, file name, or file extension. The formatted, initial capped text indicates a control or window that does not appear on the display as it is written in the manual. (For example, the control or window is not titled on the display or is graphical.) Example The LCD alternates between PUMP STOPPED and PUMP RESTARTED while restarting. Do not open the inner package outside of the sterile field. YY-MM-DD hh-mm-ssSegX.hol 11-05-25 10_40_33Seg1.hol
*.hol Press the Alarm Silence button. Italic Magenta text The emphasized words have special meaning. The emphasized words indicate a book title. The formatted text is a link. In the PDF version of the manual, the text is a hyperlink. This method is called tethered operation. Refer to The HeartAssist 5 VAD System Operators Manual for more information. www.reliantheart.com Tips, notes, cautions, and warnings This manual uses special notices including tips, notes, cautions, and warnings to call out important information. The following sections describe the meaning of these notices. Tips Tips convey helpful hints and shortcuts. Example:
You can only adjust the motor speed (increase or decrease) when the VAD is running. Notes Notes convey important information that does not pertain to data loss, equipment damage, or personal injury. Example:
ReliantHeart Confidential Patient and Heath Care Provider Use 23 The power adapter is universal for both domestic and European AC input voltages. Cautions Cautions indicate possible data loss or equipment damage. Example:
Connecting batteries other than as described can result in permanent damage to the unit. Warnings Warnings indicate possible bodily injury or death. Example:
Do not store or use the Independent Power Supply near water or any liquid (for example, in the bathroom or kitchen) due to the risk of electrical shock. Description of chapters This manual gives you and your caregiver the information that you need to use and manage the HeartAssist 5 VAD System. The manual covers normal use and also explains how to handle emergencies. Read the entire manual before using the HeartAssist 5 VAD System without supervision. Table 2-2 describes the type of information contained in each chapter. For more information, refer to the appropriate chapter. Table 2-2. The HeartAssist 5 VAD System Patient Users Manual chapter descriptions Chapter Title Contents Figures Tables Warnings Cautions Chapter 1 Emergency information Description Sequential reference of chapters, headings, and subheadings in this manual Sequential reference of graphics in the manual Sequential reference of tables in the manual General warnings for VAD patients Sequential reference of the warnings that appear in the chapters and appendices of this manual General cautions for VAD patients Sequential reference of the cautions that appear in the chapters and appendices of this manual Who to call for emergencies, equipment service, or general health concerns When to call for help 24 HeartAssist 5 VAD System Patient User's Manual Chapter Chapter 2 Title About this manual Chapter 3 Description of the HeartAssist 5 VAD System Chapter 4 Getting started with your HeartAssist 5 VAD System Chapter 5 Everyday use and self care Chapter 6 Equipment care and maintenance Chapter 7 The pediatric patient on HeartAssist 5 LBSA VAD support Appendix A Troubleshooting Appendix B Controller messages and alarms Appendix C System specifications Appendix D Manufacturer guidance for environmental conditions Index Description How the manual is arranged and what information is presented in each chapter The conventions used in this manual Why patients need the HeartAssist 5 VAD System and what it does Names and images of the HeartAssist 5 VAD System components Managing the Controller, VADPAK, and power supply General information about the HeartAssist 5 VAD System Verifying that the VAD is working properly Steps to perform every day Allowed and prohibited activities while using this device Patient care away from the hospital Maintaining the VAD and components Cleaning the components Information specific to pediatric patients on HeartAssist 5 LBSA VAD support Special considerations for children using the HeartAssist 5 LBSA VAD Appropriate action take in an emergency Troubleshooting the HeartAssist 5 VAD System Information on the Controller message screens Controller alarm meanings General specifications for the HeartAssist 5 VAD system components Information on the use of connecter cables and power cords, the proper replacement of fuses, and the essential performance of the HeartAssist 5 VAD Operating temperatures and other environmental conditions for the HeartAssist 5 VAD System Conditions to avoid while using the HeartAssist 5 VAD System Alphabetical reference of major concepts, processes, and system components ReliantHeart Confidential Patient and Heath Care Provider Use 25 26 HeartAssist 5 VAD System Patient User's Manual Chapter 3 Description of the HeartAssist 5 VAD System In this chapter Introduction ................................................................................................................................... 3-2 Indications and contraindications for use ...................................................................................... 3-2 Potential complications ................................................................................................................. 3-3 Maintenance .................................................................................................................................. 3-3 System components ...................................................................................................................... 3-3 Implantable components .................................................................................................. 3-4 Wearable components ..................................................................................................... 3-5 Accessories ................................................................................................................................... 3-7 Patient accessories .......................................................................................................... 3-7 Hospital accessories ........................................................................................................ 3-8 Symbols used in labeling .............................................................................................................. 3-8 Documentation ............................................................................................................................ 3-11 ReliantHeart Confidential Patient and Heath Care Provider Use 31 Introduction The VAD is a miniaturized, auxiliary heart pump, or ventricular assist device (VAD). The VAD is 30 mm x 76 mm, weighs 92 grams (less than 4 ounces), and is designed to provide increased blood flow to patients who suffer from heart failure. It is capable of pumping in excess of 10 liters per minute. The HeartAssist 5 VAD is intended for patients with a BSA > 1.5, and the HeartAssist 5 LBSA VAD is intended for patients with a BSA < 1.5. All of the material presented in the HeartAssist 5 VAD System Operators Manual is true for both devices. Figure 3-1. The HeartAssist 5 VAD System Outflow Graft Flow Probe Battery Pockets and Batteries Controller Pump Inflow Cannula Percutaneous Cable Indications and contraindications for use The VAD is intended for use in patients with end stage heart failure who would benefit from the implantation of a left ventricular assist device and in whom the device's implantable components fit properly. The HeartAssist 5 VAD is intended for use in the hospital and outside of the hospital, or for transportation of VAD patients via ground ambulance, fixed wing aircraft, or helicopter. The VAD is contraindicated in patients who cannot tolerate anticoagulation therapy. 32 HeartAssist 5 VAD System Patient User's Manual Potential complications The medical risks associated with the use of the HeartAssist 5 VAD System include the following adverse events:
Bleeding Re-operation Hemolysis Infection (all causes) Renal dysfunction Hepatic dysfunction Right ventricular dysfunction Neurological dysfunction Thromboembolism Mechanical or electrical failure Maintenance The HeartAssist 5 VAD System does not require any user maintenance other than charging batteries. The individual life of a fully charged battery is approximately 4.5 7 hours depending on pump speed. Patients must recondition batteries occasionally and recharge batteries regularly. System components The HeartAssist 5 VAD System consists of implantable components, wearable components, and accessories as well as patient and hospital documentation. Tables 3-1 through 3-4 list the components that are used throughout your time on VAD support. ReliantHeart Confidential Patient and Heath Care Provider Use 33 Implantable components Table 3-1 lists the implanted HeartAssist 5 VAD System components. Table 3-1. Implantable components Example Component HeartAssist 5 VAD (VAD) Outflow graft Description The VAD with inflow cannula, wedge nut, flow probe, and percutaneous cable attached. The VAD is connected to the heart via the inflow cannula, which is inserted into the apex of the left ventricle. A three-phase electric motor is integrated in the VAD and driven by the Controller. The VAD is connected to the Controller via the percutaneous cable that is passed through the skin at the exit site. The VAD is fully implanted in the patient (with the exception of a portion of the percutaneous cable), and thus does not have a user interface. The VAD is the CF Applied part. The outflow graft consists of a pre-clotted gelatin weave graft. It is attached to the distal end of the VAD with the wedge nut and is anastomosed to the ascending aorta. Graft protector The graft protector is a plastic cover that attaches to the flow probe and protects the outflow graft. Flow probe The flow probe is a custom ultrasonic real-time flow sensor. It accurately measures the flow passing through the graft. Sewing ring The sewing ring is a silicone ring wrapped in polyester with drawstring Prolene 0 sutures used to attach the inflow cannula to the apex of the left ventricle. 34 HeartAssist 5 VAD System Patient User's Manual Wearable components Table 3-2 lists the HeartAssist 5 VAD System components that you wear. Table 3-2. Wearable components Example Component Controller Lithium ion Description The Controller regulates the speed and supply of power to the VAD, displays current operating parameters, and provides visual and audible alarms. The Controller contains the power management system, the motor controller, data acquisition memory, software, a microprocessor, and ultrasonic flow measurement system, and a system to provide GSM cell phone connectivity to transmit pump data for remote monitoring. The Controller includes two battery cables and one driveline cable for the VAD connection. ReliantHeart supplies a spare Controller with each patient to allow for Controller exchange in emergency situations. Each battery supplies power to the VAD for up 7.5 hours. The battery includes a button indicator consisting of LEDs which indicate the charge level of the battery. VADPAK The VADPAK carries the VADPAK Insert, which contains the Controller and two battery pockets with batteries inserted. ReliantHeart Confidential Patient and Heath Care Provider Use 35 Component VADPAK Insert Description The VADPAK Insert is a reinforced fabric organizer for the Controller, battery pockets, batteries, and associated cables. It allows you to easily manage and transport the HeartAssist 5 VAD System during everyday use. Example Defibrillation cover The defibrillation cover protects the patient from harm if defibrillation is needed. It is not intended to secure the percutaneous cable to the Controller cable. The defibrillation cover does not protect against fluid ingress. Battery pockets The battery pockets connect the batteries and all external power sources to the Controller. The battery pockets have an integrated quick release feature to allow for easy removal of the batteries. 36 HeartAssist 5 VAD System Patient User's Manual Accessories Tables 3-3 and 3-4 describe the patient and hospital accessories available for the HeartAssist 5 VAD System. Patient accessories Table 3-3 lists the HeartAssist 5 VAD System patient accessories. Table 3-3. Patient accessories Component LVAD Battery Charger Example Description The LVAD Battery Charger charges and reconditions the system batteries. The charger contains LED status indicators. The charger requires up to 3.5 hours to fully charge a battery and between 10 14 hours to recondition a battery. Independent Power Supply The Independent Power Supply provides mains
(AC) electricity to the Controller. When you are using the Independent Power Supply, the VAD is not consuming battery power, and the Controller displays the external power indicator
(a plug symbol) on the front panel. This symbol indicates that the system is using an external power source:
Shower bag The shower bag protects the VADPAK Insert, Controller, cables, battery pockets, and batteries while you shower. ReliantHeart Confidential Patient and Heath Care Provider Use 37 Hospital accessories Table 3-4 lists the components used by the hospital staff. Table 3-4. Hospital accessories Component HeartAttendant Example Description The HeartAttendant is used to program the Controller, displays VAD performance and data, and provide mains (AC) power to the Controller. It can transmit data via an internet connection. This device is password protected. It is connected to the Controller via the HeartAttendant connector cable. Surgery pouch The surgery pouch is a non-sterile, disposable pouch that holds the Controller during surgery. Symbols used in labeling Table 3-5 lists the symbols used in ReliantHeart product labeling and provides a description of their meaning. Table 3-5. Product labeling symbols Symbol Description Authorized EC representative in the European Community Batch code Batteries enclosed Battery connection battery 1 Battery connection battery 2 Catalog or reference number 38 HeartAssist 5 VAD System Patient User's Manual Symbol Description Caution; consult accompanying documents CE mark Consult operating instructions Danger; risk of electrical shock Defibrillation proof type CF applied part Diameter Do not reuse; applies to single-use devices Do not discard in trash Do not use if damaged Double insulated Fire hazard For use within temperature limits ReliantHeart Confidential Patient and Heath Care Provider Use 39 Symbol Description Fragile General caution General warning Item showing sterilization method: ethylene oxide Latex free Manufactured on YYYY-MM or Manufactured on YYYY-MM-DD Manufacturers name and address Nationally recognized safe testing lab label Serial number Use by YYYY-MM or Use by YYYY-MM-DD 310 HeartAssist 5 VAD System Patient User's Manual Documentation Table 3-6 lists the documentation available for the HeartAssist 5 VAD System. Table 3-6. HeartAssist 5 VAD System documentation set Document The HeartAssist 5 VAD System Patient Users Manual
(this book) Audience Patients and caregivers The HeartAssist 5 VAD System Operators Manual Medical personnel and technical staff Description This manual is a user guide intended for HeartAssist 5 VAD System patients and caregivers. It contains descriptions and usage information for the end user of the HeartAssist 5 VAD System. This manual is a user guide intended for HeartAssist 5 VAD System surgeons, technical support staff, and other medical personnel. It contains detailed instructions for surgical procedures and system setup for HeartAssist 5 VAD System medical and technical staff. ReliantHeart Confidential Patient and Heath Care Provider Use 311 312 HeartAssist 5 VAD System Patient User's Manual Chapter 4 Getting Started with Your HeartAssist 5 VAD System In this chapter Introduction ................................................................................................................................... 4-2 General considerations ................................................................................................................. 4-2 Controller ....................................................................................................................................... 4-2 Overview .......................................................................................................................... 4-3 Controller display ............................................................................................................. 4-3 Controller sounds ............................................................................................................. 4-4 Controller messages and alarms ..................................................................................... 4-4 Battery indicators ............................................................................................................. 4-5 Flow sensor ...................................................................................................................... 4-5 Wireless radio antenna .................................................................................................... 4-5 Automatic fail-safe mode ................................................................................................. 4-6 VAD restart algorithm ....................................................................................................... 4-6 Controller replacement ..................................................................................................... 4-7 Controller safety check .................................................................................................. 4-14 Battery pockets ........................................................................................................................... 4-15 VADPAK ...................................................................................................................................... 4-16 VADPAK components .................................................................................................... 4-16 Setting up the VADPAK Insert ....................................................................................... 4-16 Connecting to external power ........................................................................................ 4-21 Power supply ............................................................................................................................... 4-22 Batteries ......................................................................................................................... 4-22 LVAD Battery Charger ................................................................................................... 4-28 Independent Power Supply ............................................................................................ 4-30 Connecting the Independent Power Supply to the Controller ........................................ 4-32 ReliantHeart Confidential Patient and Heath Care Provider Use 41 Introduction You should practice connecting the components of the HeartAssist 5 VAD System with your support team personnel before you attempt to connect them on your own. This practice allows you to become familiar with each part of your system, how they connect, and what they do. If you have any questions during the system connection, ask your support team personnel for more information. General considerations The Controller has alarm sounds and light indicators to alert you about important system conditions and a display that provides textual information about these conditions. For a complete description of these messages and alarms, see Appendix B, Controller messages and alarms. Protect the power cords and equipment cables. Do not put them where people walk. Do not allow anything heavy to rest on top of or roll over the cables. Avoid pinching cables in doors, drawers, and so forth. To avoid the possibility of electrical shock, contact the support team regarding the replacement of frayed or damaged cords and plugs. Only use the power cables supplied by ReliantHeart. Ensure that the mains (AC) input voltage is appropriate for the local power source. Do not use extension cords. All equipment should sit on a hard, flat, stable surface. Do not place them on surfaces that could allow them to tip over. Plug this equipment into grounded outlets only to reduce the risk of shock. If the power outlets are not grounded, an electrician must install grounded outlets before you can use this equipment outside of the hospital. To avoid accidentally switching off the power to your VAD, use outlets that are not connected to any wall or light switches. Set up your equipment near outlets that meet these requirements. Do not block fans or ventilation holes of the equipment. Blocking these openings can cause heat to build up inside and damage the equipment. Controller The Controller provides power to run the VAD, and it displays VAD operating parameters such as speed, flow, and power usage. It also displays remaining battery life and wireless 42 HeartAssist 5 VAD System Patient User's Manual antenna status. The Controller is equipped with an internal radio for one-way wireless transmission of data from the Controller to a secure server. The Controller is designed to be reliable and easy to operate. Users can choose the Controller option to transmit pump data by radio frequency transmission, but activating this option is not required for the device to fulfill its intended use or to meet the indications for use. Overview The Controller has two battery cables and one driveline cable for VAD connection. (See Figure 4-1.) A liquid crystal display (LCD) is integrated into the Controller to display the operational parameters of the VAD as well as any emergency or diagnostic alarms that might occur. (See Figure 4-2 on page 4-4.) Figure 4-1. Controller Controller display The Controller front panel allows you manage alarms and to monitor system status. Controller front panel features The front panel of the Controller contains the following features:
LCD display Two battery indicator light emitting diodes (LEDs) Fail-safe and emergency mode indicator LED The indicator LED is red when it activates. It is a solid red for fail-safe alarms, and it flashes red for emergency alarms. Alarm Silence button Scroll Display button Figure 4-2 shows an example of the Controller front panel display. ReliantHeart Confidential Patient and Heath Care Provider Use 43 Figure 4-2. Controller front panel Battery 1 Indicator Battery 2 Indicator LCD Display Alarm Silence Button Fail-safe and emergency mode indicator LED Scroll Display Button Adjusting Controller front panel brightness Use the following steps to adjust the Controller backlight display brightness:
1. On the Controller, press the Scroll Display button, and hold it for five seconds. The Controller display flashes when five seconds has passed. Release the Scroll Display button. The Controller front panel displays the + and buttons and a slider, indicating the current brightness level. 2. 3. Press the + button to increase the brightness, or press the button to decrease the brightness. The brightness slider indicates the new brightness level. Controller sounds The Controller emits three distinct sounds:
A diagnostic alarm is indicated by a slower beeping sound. An emergency alarm is indicated by a faster, loud, ringing two-tone sound. A Controller failure is indicated by a continuous tone. Controller messages and alarms The LCD screen on the front panel of the Controller displays three types of messages:
Standard messages Diagnostic alarms Emergency alarms Standard messages You can review seven standard information messages on the front panel of the Controller by pressing the Scroll Display button. With the first press of the Scroll Display button, the LCD backlights, and each subsequent press changes the display from one message to the next in a continuous loop. 44 HeartAssist 5 VAD System Patient User's Manual Emergency alarms When the Controller displays an emergency alarm, the pump is stopped, the back light automatically lights, an audible alarm sounds, and the emergency alarm indicator flashes red. The Controller continues to audibly and visually alarm until you resolve the condition causing the alarm. Pressing the Alarm Silence button has no effect. After you resolve the condition causing the emergency alarm, the alarm automatically clears. Diagnostic alarms When the Controller displays a diagnostic alarm message, the back light automatically lights, and an audible alarm sounds. Pressing the Alarm Silence button silences the alarm. Normal mode In normal operating conditions with no alarms, the Controller LCD back light is off, and the Controller displays standard message screen 1: battery status. Battery indicators The battery indicators on the top corners of the Controller front panel indicate three different conditions for each battery. For a description of these indicators, see Table 4-2, Controller battery indicator descriptions, on page 4-26. Flow sensor The Controller contains an integrated flow sensor board that works with the implantable flow probe. The quality of the flow signal is indicated by the received amplitude shown on one of the screens of the Controller. See Figure B-4, Standard message screen 4: flow probe received amplitude, on page B-3 as an example. Any voltage above one volt on either channel A or B indicates that the flow signal quality is acceptable. Wireless radio antenna The Controller contains an internal wireless radio antenna for one-way, wireless, machine-to-machine transmission of data from the Controller to a secure server. You can disable the wireless antenna (the equivalent of placing the unit in airplane mode) as needed. Users have the option to allow the Controller to transmit pump data by radio frequency transmission, but this option is not required for the device to fulfill its intended use or to meet the indications for use. Use the following steps to enable and disable the wireless antenna:
1. On the Controller, press Alarm Silence button, and hold it for five seconds. The Controller display flashes when five seconds has passed. 2. Release the Alarm Silence button. The Controller front panel displays the + and buttons and a wireless antenna symbol. If the wireless radio antenna is disabled, the front panel also displays a circle-backslash symbol. ReliantHeart Confidential Patient and Heath Care Provider Use 45 3. Press the + button to activate the wireless antenna, or press the button to disable the antenna. See Figure B-3, Standard message screen 3: wireless antenna status, on page B-3 for examples of the wireless antenna Controller display. Always disable the wireless radio antenna prior to boarding an aircraft. Automatic fail-safe mode ReliantHeart equips the Controller with features to provide fail-safe operation in the event of failure of the internal central processing unit (CPU). The fail-safe mode operation bypasses the CPU entirely and runs the HeartAssist 5 VAD at the last set speed. Fail-
safe mode operation activates automatically. In this situation, the Fail-safe and emergency mode indicator LED on the Controller front panel changes from off to solid red, and the Controller sounds a continuous high-pitched tone alarm. If these conditions exist, replace the Controller, and contact your support team immediately for instructions. VAD restart algorithm The Controller contains a sophisticated restart algorithm that attempts to restart the VAD in case of desynchronization or a VAD stoppage. Automatic restart If the VAD becomes desynchronized due to the loss of the back-EMF signal or other momentary VAD stoppage, the Controller attempts to restart the VAD in approximately two seconds. If this attempt occurs, the LCD displays PUMP STOPPED then PUMP RESTARTING (only while the VAD is attempting to restart). If the VAD restarts on the first attempt, the LCD screen clears and returns to the standard message screen 1: battery status. If the VAD does not restart on the first attempt, the PUMP STOPPED emergency alarm sounds as well as any additional alarms that can diagnose why the VAD has stopped. (Examples of additional alarms include BOTH BATTERIES DISCONNECTED or VAD DISCONNECTED.) The Controller attempts to restart the VAD for approximately 60 seconds. First, the Controller attempts to restart the VAD three times with a four-second pause between each attempt. If these initial attempts are unsuccessful, the cycle is repeated two more times with a 10-second pause between each set of attempts. The Controller attempts to automatically restart the VAD up to nine times. Manual restart If the nine attempts to automatically restart the VAD are unsuccessful, the Controller ceases any further attempts to restart the VAD. Initiate manual restarts with the following method:
1. Disconnect the battery pockets from any external power sources (such as the Independent Power Supply). 2. Briefly remove both batteries from the battery pockets. 3. Re-insert one of the charged batteries into one of the battery pockets. This action activates the restart algorithm, which triggers an additional nine automatic restart attempts. 46 HeartAssist 5 VAD System Patient User's Manual Only attempt to manually restart the VAD one time. If the VAD does not successfully restart, immediately begin the procedure detailed in the next section, Controller replacement. When the pump restarts, the PUMP STOPPED emergency alarm automatically clears. Controller replacement Replace the Controller only when it is absolutely clear that the existing Controller has malfunctioned. Read all instructions thoroughly before replacing the Controller. Setting up the equipment Use the following steps to replace the Controller. 1. Locate the necessary backup equipment:
Backup Controller Independent Power Supply or at least one charged battery Figure 4-3. Backup equipment for replacing the Controller 2. Remove the VADPAK Insert from the VADPAK. ReliantHeart Confidential Patient and Heath Care Provider Use 47 Figure 4-4. Removing the VADPAK Insert from the VADPAK 3. Arrange all of the components in the VADPAK Insert and all of the backup equipment so that they are easy to access. Figure 4-5. Arranging the components for easy access Ensure that there is at least one charged battery or an external power source available. 48 HeartAssist 5 VAD System Patient User's Manual Connecting the backup Controller The patient must sit or recline for this procedure. 1. Unscrew the defibrillation cover, by turning it counter-clockwise, to access the driveline connector. Figure 4-6. Unscrewing the defibrillation cover 2. Slide the defibrillation cover back along the driveline toward the patient. 3. Disconnect one battery pocket (with charged battery) from the Controller. Figure 4-7. Disconnecting one battery pocket from the Controller 4. Connect the battery pocket to the backup Controller. The backup Controller begins to alarm. ReliantHeart Confidential Patient and Heath Care Provider Use 49 Figure 4-8. Connecting the first battery pocket to the backup Controller 5. Pull the ribbed section of the driveline connector to disconnect it from the malfunctioning Controller. Figure 4-9. Disconnecting the percutaneous cable 6. Align the arrow on the driveline connector to the groove on the backup Controller connector. Figure 4-10. Aligning the driveline cable to the backup Controller 7. Firmly press the connectors together to connect the backup Controller to the VAD. A slight click sounds as the connectors snap into place and become fully seated. 410 HeartAssist 5 VAD System Patient User's Manual Align the driveline connector and Controller connector properly. Forcing the connectors with improper alignment can damage the equipment. Do not twist a connector plug while inserting it after the connectors are aligned. The VAD should now be running using the backup Controller. 8. Screw the defibrillation cover to the Controller cable by turning clockwise. 9. Press the Alarm Silence button. 10. Disconnect the second battery pocket from the malfunctioning Controller. Figure 4-11. Disconnecting the second battery pocket from the Controller 11. Connect the second battery pocket to the backup Controller. ReliantHeart Confidential Patient and Heath Care Provider Use 411 Figure 4-12. Connecting the second battery pocket to the backup Controller The malfunctioning Controller continues to alarm for approximately three minutes after you disconnect the power. You cannot silence this alarm. Replacing the SIM card When you replace the Controller, you must transfer the SIM card from the malfunctioning Controller to the backup Controller. Continue with the following steps to replace the SIM card. 1. Locate and use the screwdriver supplied by ReliantHeart to remove the SIM card cover located on both Controllers. Figure 4-13. Removing the SIM card cover with the ReliantHeart screwdriver 412 HeartAssist 5 VAD System Patient User's Manual Figure 4-14. SIM card covers removed from both Controllers 2. Remove the SIM card from the malfunctioning Controller. Figure 4-15. Removing the SIM card from the Controller 3. Insert the SIM card into the backup Controller. The SIM card clicks when it is properly seated. Figure 4-16. Inserting the SIM card into the backup Controller 4. Reattach the SIM card cover on both Controllers, and secure the cover using the screwdriver. ReliantHeart Confidential Patient and Heath Care Provider Use 413 Figure 4-17. Replacing the SIM card cover 5. Contact your support team immediately. The Controller replacement is now complete. Controller safety check ReliantHeart recommends a periodic safety check of the Controller to ensure continued proper operation. Perform the following steps to verify the safety of the Controller. 1. Verify that all three connections to the Controller are secure and undamaged. 2. Disconnect the Independent Power Supply from the battery pocket (if connected). 3. Verify that the percent charge of both batteries as displayed on the Controller LCD indicates a charge level above 25%. 4. Remove battery 1 from the battery pocket. 5. Verify that the % charge of battery 1 displays a line: and that the LED for battery 1 is a flashing amber light. 6. Reinstall battery 1. 7. Verify that the Controller emits three audible beeps and that the Controller LCD displays the % charge for battery 1. 8. Remove battery 2 from the battery pocket. 9. Verify that the % charge of battery 2 displays a line: and that the LED for battery 2 is a flashing amber light. 10. Reinstall battery 2. 11. Verify that the Controller emits three audible beeps and that the Controller LCD displays the % charge for battery 2. If the Controller is functioning improperly during the safety check, replace the Controller using the procedure defined in Controller replacement on page 4-7, repeat the steps in Controller safety check, and contact your support team immediately. 414 HeartAssist 5 VAD System Patient User's Manual Battery pockets The battery pockets securely hold the lithium ion batteries that power the HeartAssist 5 VAD System. Figure 4-18. Battery pocket Each battery pocket is comprised of the following components:
Green and amber LED indicators that indicate the status of the battery. External interface port that facilitates convenient connection to external power sources
(such as the Independent Power Supply). Metal belt clip that allows you to rotate the battery pocket 360 for comfortable positioning and for attaching to a belt or the VADPAK Insert for easy mobility. Retention clip that safely secures the battery in the battery pocket while providing easy access for battery insertion and removal. ReliantHeart Confidential Patient and Heath Care Provider Use 415 VADPAK The VADPAK is an ergonomic storage system that allows the patient to carry the Controller, battery pockets, and batteries (Figure 4-19). Figure 4-19. VADPAK VADPAK components The VADPAK is comprised of three components:
A removable VADPAK Insert that organizes the Controller, battery pockets, batteries, and cables. A protective pouch with a padded shoulder strap. An emergency information card with appropriate contact information. Setting up the VADPAK Insert The VADPAK Insert is a reinforced fabric organizer for the Controller, battery pockets, batteries, and associated cables. It is designed to allow easy management and transport of the HeartAssist 5 VAD System during everyday use. 416 HeartAssist 5 VAD System Patient User's Manual Figure 4-20. VADPAK Insert Use the following steps to set up the VADPAK insert. 1. Place the VADPAK Insert on a secure surface near the percutaneous cable exit site. 2. Slide the battery pockets side by side onto the matching fabric straps on the VADPAK Insert using the battery pocket belt clips. Figure 4-21. Securing the battery pockets in the VADPAK Insert 3. Slide the Controller onto the fabric strap using the Controller belt clip so that the Controller display is facing upward. ReliantHeart Confidential Patient and Heath Care Provider Use 417 Figure 4-22. Securing the Controller into the VADPAK Insert with the Controller display facing upward 4. Secure the battery connectors and cables below the Controller using the Velcro straps. Figure 4-23. Securing the battery connectors in the VADPAK Insert 5. Grasp the VADPAK Insert by the handle, and place it in the VADPAK with the Controller display visible in the clear window of the VADPAK. 418 HeartAssist 5 VAD System Patient User's Manual Figure 4-24. Placing the VADPAK Insert in the VADPAK Figure 4-25. Viewing the Controller in the clear window of the VADPAK 6. Route the driveline cable to the opening below the end of the zipper in the VADPAK. ReliantHeart Confidential Patient and Heath Care Provider Use 419 Figure 4-26. Routing the driveline cable in the VADPAK 7. Zip the VADPAK all the way to the end of the zipper to prevent the VADPAK Insert from falling out of the VADPAK. Figure 4-27. Zipping up the VADPAK completely The VADPAK is now ready to carry using the handle or the shoulder strap. You can easily remove the VADPAK Insert to aid in replacing batteries or connecting to external power sources. 420 HeartAssist 5 VAD System Patient User's Manual Connecting to external power Use the following instructions to connect the Controller to external power sources using the battery pockets external power connector. These steps are performed while the Controller is in the VADPAK Insert. These instructions apply to all external power supply sources. All external power sources share identical connectors. 1. Open the VADPAK to expose the external power connector on the bottom of the battery pocket. Figure 4-28. Exposing the battery pocket external power connector 2. Visually align the arrow on the power source connector (such as the Independent Power Supply) with the square on the battery pocket external power connector on the bottom of the battery pocket. Figure 4-29. Aligning the arrow on the power source connector with the square on the battery pocket external power connector 3. Once the arrow and the square are aligned, firmly push the power source connector straight into the battery pocket external power connector. ReliantHeart Confidential Patient and Heath Care Provider Use 421 A slight click sounds, and the connectors snap into place as they become fully seated. 4. When you are connected to a single external power source, the following indications verify your external power connection:
The Controller emits three audible beeps. The Controller screen and the connected battery pocket both display a solid green light. The external power indicator (a plug symbol) displays on the Controller screen in place of the charge time remaining for the connected battery pocket. 5. Route the connector cable and the percutaneous cable to the opening below the end of the zipper. Figure 4-30. Routing the cables in the VADPAK 6. Zip the VADPAK all the way to the end of the zipper to prevent the VADPAK Insert from falling out of the VADPAK. See Figure 4-27, Zipping up the VADPAK completely on page 4-20. The VADPAK is now ready to carry using the handle or the shoulder strap. Power supply While you are away from home, the HeartAssist 5 VAD System can draw power from a variety of sources including batteries, the Independent Power Supply. Batteries The batteries that power the VAD are lithium ion smart batteries. Each battery powers the VAD for approximately 4.5 7.5 hours, providing a combined battery time of approximately 9 15 hours. Figure 4-31 displays an example of a HeartAssist 5 VAD battery. 422 HeartAssist 5 VAD System Patient User's Manual Figure 4-31. HeartAssist 5 VAD battery Figure 4-32 displays an example of the charge level indicators on a battery. Figure 4-32. Battery charge level LED indicators Each battery contains an integrated charge level indicator display consisting of four LEDs on the face of the battery. The LEDs represent the maximum charge level the battery contains in 25% increments. Table 4-1 describes the LED battery charge level indicators. To activate the charge level indicator display on the battery, press the circular Check button above the indicator LEDs. ReliantHeart Confidential Patient and Heath Care Provider Use 423 Table 4-1. Battery charge level LED indicators Charge level indicator LEDs on battery 4 3 2 1 red 1 flashing red Percent charged 75% 100%
50% 75%
25% 50%
10% 25%
Below 10%
The battery in Figure 4-32 is 25% 50% charged. Battery time can vary from patient to patient depending on the set VAD speed. Connecting a battery pocket to the Controller The Controller connects to the battery pockets with connectors that are on the end of cables extending from the units. The Controller has two connectors that connect to the battery pockets, and these connectors are designed for ease of use. Use the following steps to connect the battery pocket connectors to the Controller connectors. 1. Visually align the arrow on the battery pocket connector with the square on the Controller connector. Figure 4-33. Aligning the arrow on the battery pocket connector with the square on the Controller connector 2. After you align the arrow and the square, firmly push the battery pocket connector straight into the Controller connector. 424 HeartAssist 5 VAD System Patient User's Manual A slight click sounds, and the connectors snap into place as they become fully seated. The Controller emits three audible beeps, and the Controller LCD displays the percent charge for the connected battery pocket. If the connected battery is either discharged or expired, the battery indicator LED for that battery pocket flashes an amber light, and the Controller emits audible alarms and displays visual alarms. Figure 4-34. Batteries connected to the Controller Alternately, if you cannot visually align the arrow and the square, use the following steps:
a. Gently insert the battery pocket connector 2mm (1/16 of an inch). b. With very little pressure applied, rotate the battery pocket connector until it mates with the Controller connector and no longer rotates freely. c. Firmly push the battery pocket connector straight into the Controller connector until they are fully seated. Align all connectors properly. Forcing connectors without proper alignment can damage the equipment. Do not try to force a power source connector into the battery pocket external power connector. When removing a cable, hold the connector, and pull it out. Do not twist the connectors while inserting them or removing them after the connectors are aligned. Both battery pocket connectors are identical. The Controller automatically switches to draw power from the appropriate battery. When an external power source (such as the Independent Power Supply) is connected to the battery pocket external power connector, the power source bypasses the battery in the battery pocket and supplies power directly to the Controller port. The Controller displays the external power indicator (a plug symbol) in place of the battery charge percentage. ReliantHeart Confidential Patient and Heath Care Provider Use 425 Interpreting Controller battery indicators The battery indicators on the top corners of the Controller front panel indicate three different conditions for each battery. See Figure 4-2, Controller front panel, on page 4-4 for an example of the battery indicators. Table 4-2. Controller battery indicator descriptions Flashing ambera Indicator condition Solid green Meaning This battery pocket is connected to external power, and the Controller is using external power from this battery pocket to run the VAD. This battery pocket contains either a discharged, an expired, or no battery. This battery pocket contains a battery with an adequate charge level, which is correctly installed and is in use or is ready for use. Flashing amber lights indicate batteries that should be changed. Always change batteries with flashing amber lights before batteries with no lights. The Controller always uses the battery with the lower charge and continues to use the battery down to a 25% charge level, thus preserving the battery with the highest charge for later use. You must periodically (every two to three hours) visually inspect the front panel of the Controller to verify battery status in case of a diagnostic audible alarm failure. Off a Changing a battery Use the following steps to change a battery. 1. Determine which battery to change by selecting the one with the lower charge using one of the following methods:
Use the LCD display on the Controller. See Figure B-1, Standard message screen 1: battery status, on page B-2. Use the battery indicator LED on the Controller or battery pockets. See Table 4-2, Controller battery indicator descriptions, on page 4-26. Press the battery charge level indicator Check button on each battery to determine its charge level. Batteries with adequate charge levels have no indicator lights on the Controller and battery pockets. Batteries with flashing amber indicator lights on the Controller and battery pockets have less than a 25% charge level and should be changed first. See Table 4-2, Controller battery indicator descriptions, on page 4-26 for other battery conditions and Figure 4-32, Battery charge level indicators, on page 4-23. 2. Ensure that the remaining battery indicates adequate charge on the Controller LCD display. 3. Remove the battery with the lower charge from the battery pocket. 426 HeartAssist 5 VAD System Patient User's Manual Figure 4-35. Removing the battery from the battery pocket 4. Verify that the battery to be inserted is fully charged by pressing the battery level charge indicator Check button on the battery itself. See Table 4-1, Battery charge level LED indicators, on page 4-23. All four LEDs on the battery should illuminate, indicating a charge between 75% and 100%. 5. Align the connector on the battery with the receptacle in the pocket, and insert the charged battery into the pocket until it clicks. The Controller emits three audible beeps, and the Controller LCD displays the percent charge for the connected battery. Any flashing amber indicator lights turn off. The BATTERY DISCHARGED and BATTERY DISCONNECTED alarms clear automatically. 6. Verify the percent charge of the replaced battery on the Controller LCD display. See the following section, Verifying battery charge status. Only remove one battery at a time from the battery pockets. Removing both batteries simultaneously causes the VAD to stop (unless you are in tethered mode). The batteries must be reconnected as quickly as possible to resume VAD function. ReliantHeart Confidential Patient and Heath Care Provider Use 427 Do not handle batteries by the connector pins. A strong static discharge can cause the charge level indicator to temporarily malfunction. If the charge level indictor ceases to function, place the battery into a ReliantHeart charger, and recharge the battery. Verifying battery charge status Use one of the following methods to check the charge status of either battery:
Look at the Controller LCD display. Press the Check button on the battery, adjacent to the battery charge indicator LEDs. See Table 4-1, Battery charge level LED indicators, on page 4-23 for a description of the LED meanings. Even when they are connected to an external power source (such as the Independent Power Supply), the batteries located inside the battery pockets drain and lose charge over time. Verify that the two batteries in the battery pockets have sufficient charge levels prior to disconnecting the system from an external power source. Verifying battery capacity Battery capacity number refers to the total power available from the battery when fully charged. As the battery ages with normal use, this number decreases. Verify the total battery capacity using standard message screen 6: battery capacity on the Controller. (See Figure B-6 on page B-3.) The screen displays the maximum battery capacity in milliamp hours. Once a battery displays a total capacity of 6000 milliamp hours or less, contact your support team for a replacement battery. Obtain replacement batteries from ReliantHeart after the battery capacity indicates less than 6,000 milliamp hours. Only use batteries supplied by Reliant Heart. A battery that displays less than 6000 milliamp hours is still a good battery; however, the battery might not provide as much total support time as a new battery. LVAD Battery Charger Figure 4-36 displays the LVAD Battery Charger. It charges and reconditions batteries used with the HeartAssist 5 VAD System. Table 4-3, LVAD Battery Charger status lights description, on page 4-30 describes the charge indicator lights. With batteries, the LVAD Battery Charger weighs approximately 3.6 pounds (1.7 kg). It is enclosed in a durable case that is both moisture and flame resistant. 428 HeartAssist 5 VAD System Patient User's Manual Figure 4-36. LVAD Battery Charger Certain battery charger can only charge or recondition one battery at a time. This is denoted by the recondition arrow solely indicating the left bay as the reconditions lot. Please verify the proper model before following the steps for charging or reconditioning of batteries.. Connecting to a power source Use the following steps to connect the LVAD Battery Charger to wall power. 1. Plug the main power cord into the AC power input on the LVAD Battery Charger. 2. Connect the plug to an AC power source. The power adapter is universal for both domestic and European AC input voltages. Charging batteries Use the following steps to charge the batteries. 1. 2. 3. 4. Allow 5 10 seconds for the LVAD Battery Charger to recognize the battery. Identify the appropriate model, before attempting reconditioning or charging. Inspect the connector end of each battery to ensure that it is clean. Insert one or two batteries into the two bays of the LVAD Battery Charger. Depending on model type, the charger can charge one or two batteries simultaneously.. The charging process can take up to 3.5 hours per battery. If the battery status light below the battery bay flashes green, the battery is charging. If a battery status light flashes red, the battery charger is in error mode. If the battery status lights flash a red color, you must remove both batteries and unplug the power cord. Wait 15 seconds, reinsert the batteries, and reconnect the power cord. If the batteries are warm, wait for 30 minutes before reinserting them. ReliantHeart Confidential Patient and Heath Care Provider Use 429 Always check batteries by pushing the charge level indicator Check button on the battery to verify charge level when removing batteries from the LVAD Battery Charger. Using a battery charger that is not supplied by ReliantHeart could result with batteries that could be charged inappropriately causing an over or under charged condition resulting in discharge times that are noticeably shorter than intended. Table 4-3 describes the LVAD Battery Charger status lights. Table 4-3. LVAD Battery Charger status lights description Light status Off Green flashing Green solid Amber flashing Amber and green Amber solid Red flashing Battery status No battery Fast charging Fully charged Reconditioning Reconditioned Standby or Suspend Error Reconditioning batteries To maintain the accuracy of the battery indicators, batteries must occasionally run through a recondition cycle. Use the following steps to recondition batteries. 1. Place the battery into the left bay, for chargers with only one reconditions slot. Use either slot with the charger capable of reconditioning in either position. 2. Press the Recondition button on the front label of the charger, directly below the battery slot. The reconditioning process can take up to 9 hours. Connection other than indicated can result in permanent damage to the LVAD Battery Charger. Avoid placing or operating the LVAD Battery Charger in areas or near appliances that expose it to temperatures outside of the operating range of the device, which is 0 C (32 F) to 50 C (122 F). Independent Power Supply The Independent Power Supply is a portable power supply that supplies AC power to the VAD via the battery pocket external power connector. Use this power supply as a backup power source in conjunction with the two battery pockets containing charged batteries. 430 HeartAssist 5 VAD System Patient User's Manual Figure 4-37. Independent Power Supply The Independent Power Supply is for use only by patients who are implanted with the HeartAssist 5 VAD System. Do not store or use the Independent Power Supply near water or any liquid (for example, in the bathroom or kitchen) due to the risk of electrical shock. The Independent Power Supply contains no user-serviceable parts. Do not open the back cover of the Independent Power Supply. Only qualified ReliantHeart personnel can service this equipment. If service is required, contact your support team. Avoid placing or operating the Independent Power Supply in areas or near appliances that expose it to temperatures outside the operating range of the device, which is 0 C (32 F) to 40 C (104 F) or where relative humidity is noncondensing, less than 10% Rh or greater than 75% Rh. Do not trip over the power cord. Instruct persons in the area to prevent tripping. ReliantHeart Confidential Patient and Heath Care Provider Use 431 Connecting the Independent Power Supply to the Controller Figure 4-38 and the following instructions serve as a guide for connecting the Independent Power Supply to an AC power source and to the Controller. Figure 4-38. Independent Power Supply connection diagram Use the following instructions to connect the Independent Power Supply to the Controller. 1. Plug the power cord of the Independent Power Supply into the wall plug. See 1 in Figure 4-38. 2. Plug the power cord into the Independent Power Supply. See 2 in Figure 4-38. 3. Plug the Independent Power Supply connector into the battery pocket external power connector (which is already connected to the Controller; see Connecting a battery pocket to the Controller on page 4-24). See 3 in Figure 4-38. If all connections are secure, and the components are working properly, the Controller emits three audible beeps, the Controller front panel displays the external power indicator
(a plug symbol), and the battery indicator LED on the Controllers front panel displays a solid green light for the connected battery pocket. When you are using the Independent Power Supply, the Controller uses power from the grounded AC wall outlet. The Controller can also receive backup power from the two charged batteries in the battery pockets if the wall outlet fails. If a power failure occurs, the Controller sounds an audible alarm, notifying you that it is using backup battery power. Use the Independent Power Supply only with a properly grounded plug. To reduce the risk of electrical shock, plug this equipment into grounded outlets only. If your power outlets are not grounded, an electrician must install grounded outlets before you can use this equipment outside of the hospital. 432 HeartAssist 5 VAD System Patient User's Manual Chapter 5 Everyday Use and Self Care In this chapter Introduction ................................................................................................................................... 5-2 Daily status checks ....................................................................................................................... 5-2 Upon waking .................................................................................................................... 5-2 Before sleeping ................................................................................................................ 5-2 Daily operation .............................................................................................................................. 5-3 Tethered operation ........................................................................................................... 5-3 Untethered operation ....................................................................................................... 5-3 Switching from tethered to untethered operation ............................................................. 5-4 Switching from untethered to tethered operation ............................................................. 5-5 Leaving the home ............................................................................................................. 5-6 Showering with the VADPAK Insert and shower bag ...................................................... 5-6 Activity restrictions ........................................................................................................... 5-8 Self care at home .......................................................................................................................... 5-9 Caring for the exit site ...................................................................................................... 5-9 Caring for the percutaneous cable ................................................................................. 5-10 Caring for the VADPAK .................................................................................................. 5-10 Taking medications ........................................................................................................ 5-10 Emergencies ............................................................................................................................... 5-11 Local emergency services ............................................................................................. 5-11 CPR and defibrillation .................................................................................................... 5-11 Power outages ............................................................................................................... 5-11 ReliantHeart Confidential Patient and Heath Care Provider Use 51 Introduction Hospital staff should initially supervise system management, and then, as appropriate, transfer management to the patient. Daily status checks Check the Controller, the primary and reserve batteries, the Independent Power Supply, and the LVAD Battery Charger every day as described below. Contact your support team if any of the Controller alarms are not working. Every two three hours when you are awake (whether you are attached to the Independent Power Supply or not), check the battery status on the Controller front panel. Upon waking When you awaken in the morning, check the front panel display of the Controller for lighted symbols and messages. If the Controller is displaying alarm messages, see Emergency alarms on page B-4 and Diagnostic alarms on page B-6. Before sleeping Before you go to sleep, ensure that you verify the following statuses:
Verify that the battery status lights are lit for all reserve batteries in the LVAD Battery Charger. Verify that you have two fully charged batteries in the battery pockets. Verify that the Independent Power Supply is supplying power to the Controller by performing the following steps:
a. Verify that the battery LED on the Controllers front panel is solid green for the battery pocket connected to the Independent Power Supply. b. Press the Scroll Display button on the front panel of the Controller to verify that the battery percentage is displaying the external power indicator (a plug symbol) for the battery pocket connected to the Independent Power Supply. Figure 5-1. Standard message screen 1 display on the Controller front panel when using external power Battery 2 External Power Indicator 52 HeartAssist 5 VAD System Patient User's Manual Daily operation Always connect the Controller to two power sources. The VAD draws power from one source at a time. The second source serves as backup power. When you are using the two batteries in the battery pockets as the primary and backup power sources, ensure that you check the remaining charge in each battery every hour. While you are relaxing or sleeping, use the Independent Power Supply in the tethered mode of operation (described in the following section). When you are active, you usually use the batteries in the battery pockets in the untethered mode of operation. The system is not connected to the Independent Power Supply during this time. Tethered operation During times of little activity, such as when you are sleeping or relaxing, you should use the Independent Power Supply. This method is called tethered operation. The HeartAttendant is only used while you are in the hospital and the physician wants to monitor your condition. The system must be in tethered mode whenever you think you might fall asleep or if charged batteries are not available for use in the battery pockets. When you use the Independent Power Supply the Controller uses power from the grounded AC wall outlet. The Controller can also receive backup power from the batteries in the battery pockets if the wall fails. Untethered operation When active, most patients prefer using the batteries in the battery pockets (untethered operation) instead of having the system plugged into the Independent Power Supply in tethered mode. The battery pockets must contain two fully charged batteries before you switch to untethered mode. The Controller draws power from one battery before drawing power from the second battery. This design ensures that the second battery will have energy remaining when the first battery falls below a 25% charge level. Each fully charged battery powers the VAD for approximately 4.5 7.5 hours, giving a combined battery time of approximately 9 15 hours. Higher VAD speeds can reduce battery charge levels. The Controller front panel displays the percent charge level for each battery. A fully charged battery provides adequate power to run the VAD for 4.5 7.5 hours. If the VAD speed is set high, it reduces the amount of time the battery can operate the VAD. The amount of time that you stay in untethered operation depends on the set VAD speed and the number of reserve batteries available. Only use batteries supplied by ReliantHeart. ReliantHeart Confidential Patient and Heath Care Provider Use 53 Switching from tethered to untethered operation Use the following steps to change the power source from tethered to untethered operation. Verifying battery charge Use the following steps before you disconnect from the Independent Power Supply. Verify that the charge level of the two batteries connected to the Controller is nearly full
(>80%) on the Controller front panel. Figure 5-2. Standard message screen 1 display on the Controller front panel when using battery power Battery 1 Percent Charge Remaining Battery 1 Charge Time Remaining hh:mm Battery 2 Percent Charge Remaining Battery 2 Charge Time Remaining hh:mm If one or both batteries are not near charge capacity, proceed as follows:
1. Remove one or two fully charged batteries from the LVAD Battery Charger. 2. Check the batteries by pushing the charge indicator button on each battery to verify charge level. 3. Remove only one discharged battery from the battery pocket and insert the fully charged battery. 4. Remove the second discharged battery from the battery pocket and insert the fully charged battery. Only remove one battery at a time from the battery pockets. Removing both batteries simultaneously causes the VAD to stop (unless you are in tethered mode). The batteries must be reconnected as quickly as possible to resume VAD function. 5. Check the charge level of the new battery connected to the Controller on the Controller front panel. Disconnecting from the Independent Power Supply Use the following steps to disconnect the battery pocket from the Independent Power Supply and complete the process of switching to untethered operation. Disconnect the Independent Power Supply from the battery pocket external power connector as follows:
1. With one hand, firmly hold the battery pocket external power connector. 2. With the other hand, pull the power source connector from the battery pocket external power connector. This connection might be tight and might take some force to pull loose. 54 HeartAssist 5 VAD System Patient User's Manual Do not twist the connector while removing it. Do no pull on the cables.. During untethered operation, check the charge level of both batteries in the battery pockets every hour to ensure that enough power is available.. Always disconnect the Independent Power Supply connector from the battery pocket external power connector before removing power to or turning off the Independent Power Supply. Switching from untethered to tethered operation Use the following steps to change the power source from untethered to tethered operation. Verifying Readiness Ensure that the Independent Power Supply is ready to be used. Verify that the system status light of the Independent Power Supply is a steady green. Connecting to the battery pocket external power connector Use the following general steps to connect the power source connector (Independent Power Supply connector) to the battery pocket external power connector. 1. Visually align the arrow on the power source connector with the square on the battery pocket external power connector. 2. Once the arrow and square are aligned, firmly push the power source connector into the battery pocket external power connector. You hear a slight click as the connectors become fully seated. You can damage the connectors if you force them without proper alignment. After the connectors are aligned, do not twist the power source connector while connecting it. If all connections are tight and the components are working properly, the Controller emits three audible beeps, the Controller front panel displays the external power indicator (a plug symbol), and the battery indicator LED on the Controllers front panel displays a solid green light for the connected battery pocket. If a power failure is expected to last for an extended period of time, take the Independent Power Supply, the LVAD Battery Charger, and all batteries to the nearest location with suitable mains power. Ensure that batteries that are not being used in the battery pockets are always charging in the LVAD Battery Charger while you are in the tethered mode of operation. ReliantHeart Confidential Patient and Heath Care Provider Use 55 Leaving the home Always travel with fully charged batteries, a spare Controller, a spare battery pocket, the Independent Power Supply, extra batteries and the LVAD Battery Charger. You might need these components in an emergency. When you travel away from home, carry a card, letter or other medical notification that identifies you as a left ventricular assist device (HeartAssist 5 VAD) patient. This notification should include the name and telephone number of your doctor in case of an emergency. Before going on extended trips, notify your support team. Showering with the VADPAK Insert and shower bag Your doctor will provide instructions for the exit site care before, during, and after showering. Do not shower with the VAD connected to the Independent Power Supply (in tethered mode). Showering in untethered mode reduces the risk of electrical shock. Do not submerge the Controller in liquid. Submerging the Controller in liquid might damage internal parts, causing the device to malfunction. Showers and washing are permitted when the clinician approves wound site readiness. During showers, you must use the shower bag. Do not expose the Controller to moisture. Do not submerge batteries in liquid or expose them to heat or moisture. Submerging the batteries in liquid or exposing them to heat might cause them to malfunction. During showers, you must use the shower bag to prevent exposure to moisture. Ensure that the VADPAK Insert is properly encased in the provided shower bag before showering. Use the following instructions to encase the VADPAK Insert with components into the shower bag for showering. 1. Open the top cover of the shower bag. 2. Insert the VADPAK Insert, containing the Controller, battery pockets, two charged batteries, and cables into the shower bag with the VAD percutaneous cable pointing towards the left (as viewed facing the shower bag). The percutaneous cable connection must remain dry in the shower bag. 56 HeartAssist 5 VAD System Patient User's Manual Figure 5-3. Properly inserting the Controller, battery pockets, batteries, and cables in the VADPAK Insert into the shower bag 3. Secure the percutaneous cable to the side of the shower bag using the Velcro strap attached to the left side of the shower bag. Figure 5-4. Securing the percutaneous cable to the side of the shower bag 4. Close the lid of the shower bag, and carefully press the sides of the cover inward to secure the Velcro fasteners located along each face of the shower bag. ReliantHeart Confidential Patient and Heath Care Provider Use 57 Figure 5-5. Properly closing and securing the lid of the shower bag 5. When you are finished showering, carefully dry off the outside of the shower bag, open the top cover of the shower bag, and remove the VADPAK Insert. If water has leaked into the shower bag, contact your support team immediately. Activity restrictions Do not use the VADPAK Insert and Controller in the shower bag longer than 30 minutes because the Controller requires air circulation for proper cooling. Position the shower bag so that it does not tip or drop. Do not allow the shower bag to sit in liquid. The HeartAssist 5 VAD System lets you move around and be active; however, there are some restrictions associated with the device. The following tables describe prohibited activities. The activities described in Table 5-1 are always prohibited for your safety and for the function of the device. Ask the doctor what types of activities you are allowed to perform. Table 5-1. Prohibited activities Activity Total body submersion
(swimming or bathing) Steam bath or dry saunas Do not operate the system in environments where the temperature Notes Do not submerge the Controller or batteries in water. Submerging these components can cause the device to malfunction. is less than 10 C or greater than 40 C. Hard physical contact with other people or objects could damage the external HeartAssist 5 VAD System hardware, injure internal organs, or interfere with the tissue healing at the exit site. Participation in contact sports 58 HeartAssist 5 VAD System Patient User's Manual Consult the doctor and gain prior approval before engaging in the activities described in Table 5-2. Table 5-2. Restricted activities Activity Showering Driving an automobile Flying Non-contact sports
(golfing, jogging, tennis) Notes Obtain approval from the doctor. A shower bag is also required. Obtain approval from the doctor. In addition, local laws may prohibit persons in your condition from operating motor vehicles. Obtain approval from the doctor. In addition, check with the airlines about possible special requirements. You and your doctor can determine whether participation in a certain sport could cause equipment damage or bodily harm. The activities described in Table 5-3 have no known risks. Table 5-3. Permitted activities Activity Careful sponge baths Sexual activity Housework Moderate exercise Shopping Notes No total submersion Walking, gardening, cycling, and so forth Self care at home Use the following instructions to care for yourself and HeartAssist 5 VAD System while you are away from the hospital. Caring for the exit site The tube (percutaneous cable) that protrudes from your skin contains wires that connect the HeartAssist 5 VAD to the Controller and allow the VAD and Controller to communicate. The area where the percutaneous cable comes out of your skin is called the exit site. The physicians orders supersede these cleaning instructions. You should always follow the physicians orders regarding the care of the exit site and other surgical locations. Change the percutaneous cable exit site dressing daily using strict aseptic technique
(sterile gloves minimally). 1. Gently cleanse the site with a mild disinfectant soap (preferably chlorhexidine solution). 2. Rinse with sterile normal saline solution. 3. Dry the cleansed site using a sterile 4 x 4 gauze pad. 4. Cover the cleansed and dried site with a dry, sterile dressing. ReliantHeart Confidential Patient and Heath Care Provider Use 59 Do not apply prophylactic topical agents to the exit site wound unless ordered by the physician. As you clean the exit site each day, examine it for signs of infection such as the following:
Redness Swelling Drainage Open sores or ulcers Pain Skin that is warm to the touch If any sign of infection or break in the tissue is present, contact the doctor immediately. Caring for the percutaneous cable It is extremely important that the percutaneous cable is protected from extreme or frequent bending or kinking. Damage to the percutaneous cable, depending on the degree, can cause the VAD to stop. Follow these recommendations to reduce damage to the percutaneous cable:
Do not severely bend or kink the percutaneous cable. Do not let the percutaneous cable become twisted. Allow for a gentle curve of the percutaneous cable. Do not severely bend the percutaneous cable multiple times or wrap it tightly. Keep the percutaneous cable clean. Wipe off any dirt or grime that appears. If necessary, use a towel with soap and warm water to gently clean the percutaneous cable. However, never submerge the cable or other system components in water or liquid. Do not pull on or move the cable going through the skin. Be aware of the location of the Controller at all times. Protect the Controller from falling or from pulling on the percutaneous cable. Do not allow the percutaneous cable to catch or snag on anything that will pull on or move the cable. Check the percutaneous cable daily for signs of damage (such as cuts, holes, or tears). Caring for the VADPAK The VADPAK is an ergonomic storage system that allows you to carry the Controller, battery pockets, and batteries. If you are going for a walk, disconnect the Independent Power Supply (possibly the HeartAttendant if in the hospital). Taking medications Your doctor might prescribe an anticoagulant such as warfarin (Coumadin) and might prescribe other drugs to take while you are on the HeartAssist 5 VAD support. It is important that you take these and other medications according to your doctors instructions. Contact your doctor if you have questions about your medications. 510 HeartAssist 5 VAD System Patient User's Manual Emergencies An emergency situation can be caused by medical conditions or by mechanical problems that interfere with the pumping ability of the HeartAssist 5 VAD. You and your caregivers must learn how to identify and respond to emergencies. The most important action is to restore power to your HeartAssist 5 VAD. Local emergency services You or your caregivers should brief local emergency services about your HeartAssist 5 VAD, and your caregivers should establish a plan to activate these emergency services when needed. CPR and defibrillation If defibrillation is required, you can be connected either to battery power, the HeartAttendant, or the Independent Power Supply. While you are implanted with the HeartAssist 5 VAD, you can receive cardiopulmonary resuscitation (CPR). Caregivers and health care providers might not be able to feel your pulse, even if the HeartAssist 5 VAD is operating normally, so CPR and defibrillation should not be performed if you are awake and responsive, even if a pulse is not apparent. Power outages If your current location loses power, and you are not certain when it will be restored, you must temporarily move to a location with power as soon as possible to prevent the HeartAssist 5 VAD from stopping. Bring your Independent Power Supply, LVAD Battery Charger, and reserve batteries with you to the new location. ReliantHeart Confidential Patient and Heath Care Provider Use 511 512 HeartAssist 5 VAD System Patient User's Manual Chapter 6 Equipment Care and Maintenance In this chapter Introduction ................................................................................................................................... 6-2 All HeartAssist 5 VAD System components ............................................................................... 6-2 Environmental conditions ................................................................................................. 6-2 Contact with liquids .......................................................................................................... 6-3 Electromagnetic disturbances .......................................................................................... 6-3 Service ............................................................................................................................. 6-4 Controller ....................................................................................................................................... 6-4 LVAD Battery Charger .................................................................................................................. 6-4 Independent Power Supply ........................................................................................................... 6-5 ReliantHeart Confidential Patient and Heath Care Provider Use 61 Introduction The HeartAssist 5 VAD System is made of tough, durable materials, but it does require some basic care as described in the following sections. In addition, support team personnel should perform periodic safety and function checks of your HeartAssist 5 VAD System equipment. All HeartAssist 5 VAD System components The following subsections Environmental conditions, Contact with liquids, Electromagnetic disturbances, and Service apply to all HeartAssist 5 VAD System components. Environmental conditions The HeartAssist 5 VAD System components operate under the following environmental conditions. Do not operate the Controller where temperatures are less than -10 C (14 F) or greater than 40 C (104 F), or where the relative humidity is non-condensing, less than 10% Rh or greater than 75% Rh. Do not operate the Independent Power Supply where temperatures are less than 0 C
(32 F) or greater than 40 C (104 F) or where the relative humidity is non-
condensing, less than 10% Rh or greater than 75% Rh. Do not operate the LVAD Battery Charger where temperatures are less than 0 C (32 F) or greater than 50 C (122 F), or where the relative humidity is non-condensing, less than 10% Rh or greater than 75% Rh. Do not store the system in environments where temperatures are less than 20 C
(4 F) or greater than 55 C (131 F). Do not expose the batteries to moisture or heat. Do not expose the Controller, VADPAK, VADPAK Insert, battery pockets, Independent Power Supply to moisture. The VADPAK carry bag is flame retardant, but you must be careful when using the bag near open flame or embers. Any hot item that falls onto or within the bag must be removed as quickly as possible to prevent scorching or marring of the materials. The Controller meets the IP32 rating as designated in IEC 60529 Degrees of protection provided by enclosures. This rating signifies that the Controller case protects the Controller hardware and software from dripping fluid and solid foreign objects 2.5 mm in diameter. Do not transport the HeartAssist 5 VAD System in environments where temperatures are less than 0 C (32 F) or greater than 55 C (122 F). Travel should be limited to pressure altitude of 0 2000 m (6500 ft). The altitude specification does not limit use of the device on fixed wing aircraft, since commercial planes utilize pressurized cabins. For example, when a plane is traveling at 35,000 feet altitude, the pressurized altitude inside the cabin is equivalent to 5,400 feet above sea level. 62 HeartAssist 5 VAD System Patient User's Manual Contact with liquids All HeartAssist 5 VAD System components (with the exception of the shower bag) are susceptible to damage by liquids. Keep all liquids away from HeartAssist 5 VAD System components. Keep all liquids away from equipment to avoid accidental spills. Do not put any part of this equipment under water or in other liquids. Contact with liquids increases the risk of electrical shock and of damage to the equipment. Electromagnetic disturbances Laboratory testing suggests that patients have little risk from most devices that might produce electromagnetic disturbances (such as metal detectors, microwave ovens, and cellular phones). However, such devices can affect electronic equipment at very close range. For this reason, observe the recommended separation distances in Tables D-1 through D-4 beginning on page D-2 in Appendix D, Manufacturer guidance for environmental conditions. The HeartAssist 5 VAD has been shown to have acceptable risk regarding electromagnetic disturbances, as specified by international standard IEC 60601-1-
2:2007. The system has not been tested with each possible brand of device, and the possibility of electromagnetic disturbances exists. If you experience unexpected changes in the speed of the VAD, investigate potential sources of electromagnetic disturbances (such as cellular phones, radio transmitters, or microwave ovens) within a few feet. If you discover disturbances, move away from the potential source, and determine if the VAD operation returns to normal. If it does not return to normal, contact your support team. Do not subject patients implanted with the VAD to magnetic resonance imaging (MRI). The VAD contains ferromagnetic components, and MRI can cause device failure or patient injury. Figure 6-1. MRI warning and safety seal MR unsafe ReliantHeart Confidential Patient and Heath Care Provider Use 63 VAD support equipment was assessed for basic electrical and constructional safety with respect to IEC/EN 60601-1/A2: 1995 UL2601-1: 1997 (North American Deviations to IEC 60601-1) UL60601-1: 2003 (HeartAttendant) CAN/CSA-C22.2 No. 601.1-M90 (with updates 1 and 2 for HeartAttendant) Service Service There are no user-serviceable parts in the Controller, LVAD Battery Charger, or Independent Power Supply. Contact your support team for service of this equipment. Do not service this equipment yourself. Only qualified personnel can service this equipment. If service is required, contact your support team. Do not modify this equipment. No modification of this equipment is allowed. Do not open the back cover of any ReliantHeart device. Controller The Controller does not require routine maintenance. You can wipe dust off of the surface of the device with a clean, dry, lint-free cloth, and you can clean spills from the cover with a dampened cloth. Do not drop the Controller on any hard surface. Dropping the Controller can damage internal parts causing the device to malfunction. LVAD Battery Charger The LVAD Battery Charger does not require routine maintenance. You can wipe dust off of the surface of the device with a clean, dry, lint-free cloth, and you can clean spills from the cover with a dampened cloth. 64 HeartAssist 5 VAD System Patient User's Manual Do not attempt to wipe liquid from the inside of the LVAD Battery Charger battery bays as this action might bend or otherwise damage the connector pins. Independent Power Supply The Independent Power Supply does not require routine maintenance. You can wipe dust off of the surface of the device with a clean, dry, lint-free cloth, and you can clean spills from the cover with a dampened cloth. ReliantHeart Confidential Patient and Heath Care Provider Use 65 66 HeartAssist 5 VAD System Patient User's Manual Chapter 7 The Pediatric Patient on HeartAssist 5 LBSA VAD Support In this chapter Introduction ................................................................................................................................... 7-2 Implant surgery ............................................................................................................................. 7-2 System description ........................................................................................................................ 7-2 Environmental conditions .............................................................................................................. 7-2 Temperature ..................................................................................................................... 7-2 Contact with liquids .......................................................................................................... 7-3 Electromagnetic disturbances .......................................................................................... 7-3 Electrostatic discharge ..................................................................................................... 7-4 Operating the HeartAssist 5 LBSA VAD system ........................................................................ 7-4 Batteries ........................................................................................................................... 7-4 VADPAK ........................................................................................................................... 7-4 Percutaneous cable ......................................................................................................... 7-5 Daily operation for the pediatric patient ........................................................................................ 7-5 Leaving the home ............................................................................................................. 7-5 Returning to school .......................................................................................................... 7-5 Activities ........................................................................................................................... 7-6 Travel ............................................................................................................................... 7-6 Sleeping ........................................................................................................................... 7-6 Showering and cleansing ................................................................................................. 7-6 Emergencies ................................................................................................................................. 7-6 Local emergency services ............................................................................................... 7-6 CPR and defibrillation ...................................................................................................... 7-7 Power outages ................................................................................................................. 7-7 Prevention ........................................................................................................................ 7-7 ReliantHeart Confidential Patient and Heath Care Provider Use 71 Introduction All of the material previously presented in the HeartAssist 5 VAD System Patient User's Manual is true for the pediatric patient. It is expected that pediatric patients between 5 and 16 years of age will encounter situations similar to the adult patient as described in this manual. This chapter provides guidance for situations that pediatric patients, especially younger children, might encounter and is written for the childs parents or caregivers. Parents or caregivers of pediatric patients of any age and children or adolescents with the appropriate skills should read the HeartAssist 5 VAD System Patient User's Manual thoroughly before working with the HeartAssist 5 LBSA VAD. This chapter does not repeat all of the cautions and instructions contained elsewhere in this manual, and this chapter should not be substituted for reading the entire manual. Implant surgery The HeartAssist 5 LBSA VAD is placed in your childs chest during surgery. Your childs doctor explains the surgery to both of you. When you and your child are ready after the implant operation, the hospital staff trains you and your child, if he or she is old enough, on how to operate the HeartAssist 5 LBSA VAD. System description The Controller, VADPAK, VADPAK Insert, battery pockets, batteries, LVAD Battery Charger, and Independent Power Supply that the pediatric patient uses are the same as described in Chapter 3, Description of the HeartAssist 5 VAD System. The VAD your child receives is designed to fit properly in a childs smaller chest. The HeartAssist 5 LBSA VAD operates exactly like the adult HeartAssist 5 VAD. Chapter 3, Description of the HeartAssist 5 VAD System describes how the HeartAssist 5 LBSA VAD operates. Environmental conditions HeartAssist 5 LBSA VAD system operation and storage is not recommended in certain environmental conditions, as explained in the following subsections. Temperature The following guidelines describe temperature controls for the Controller. Do not operate the Controller where temperatures are less than 10 C (14 F) or greater than 40 C (104 F) or where the relative humidity is noncondensing,
<10% Rh or >75% Rh. 72 HeartAssist 5 VAD System Patient User's Manual Your child must wear the Controller at all times, or your childs HeartAssist 5 LBSA VAD will not run. Therefore, you must not allow your child to spend time in areas with temperatures outside of the specified range of 10 C (14 F) or greater than 40 C (104 F) or to place the Controller in locations where this temperature range can be exceeded
(for example, near heaters, radiators, or air conditioners). The batteries, Controller, battery pockets, VADPAK, and VADPAK Insert must not be exposed to moisture or heat. The batteries must not be exposed to extreme heat. You must monitor his or her temperature when your child is playing in very hot environments such as the beach. Children on HeartAssist 5 LBSA VAD support must not stand in front of or come in contact with sources of heat such as fireplaces, space heaters, stoves, and so forth. As a reminder, your childs LVAD Battery Charger or Independent Power Supply should never be placed close to these types of heat sources. The VADPAK carry bag is flame retardant, but you must exercise care when using the bag near open flame or embers. Remove any hot item that falls onto or within the bag as quickly as possible to prevent scorching or marring of the materials. Take special care if your child is around campfires or other sources of open flame. Teach your child to stay a safe distance away from them. Contact with liquids All forms of liquid must be kept away from the equipment in order to prevent accidental spills. For example, you might want your child to wear an apron or bib while eating so that food or drinks dont spill on the VADPAK or its components. The equipment must never be submerged in any liquid. Young children might need to be watched carefully when they are near sources of water, such as the bathroom, as they might attempt to put their equipment in places like the toilet. Your child will not be able to swim or take a full bath while supported by the HeartAssist 5 LBSA VAD. Bathing while wearing the HeartAssist 5 LBSA VAD is described in Showering with the VADPAK Insert and shower bag on page 5-6. Whenever your child is mobile or operating in the untethered mode (operating the HeartAssist 5 LBSA VAD on batteries alone), he or she will have two batteries, two battery pockets, and the Controller in the VADPAK, using the VADPAK Insert. The batteries, the battery pockets, and the Controller must not get wet. You must not allow your child to swim or play in water in a way that allows moisture to enter the VADPAK and come in contact with the batteries, the battery pockets, or the Controller. On days with heavy rains, it might be helpful to ensure that your child is wearing rain gear or the shower bag to protect the VADPAK, the Controller, the batteries, and the battery pockets when he or she goes outside. Limit the time that the Controller and accessories are in the shower bag and the shower to 30 minutes. Electromagnetic disturbances Laboratory testing suggests that there is little risk from most devices that can produce electromagnetic disturbances (such as metal detectors, microwave ovens, and cellular phones) with the HeartAssist 5 LBSA VAD. However, these types of devices can affect electronic equipment at very close range. For this reason, observe the recommended ReliantHeart Confidential Patient and Heath Care Provider Use 73 separation distances in Table D-4, Recommended separation distance between portable and mobile RF communications equipment and the life-supporting ME equipment and ME systems, on page D-5. The system has not been tested with each possible brand of these devices, and the possibility of electromagnetic disturbances might exist. You must observe your childs HeartAssist 5 LBSA VAD functions, such as flow and speed, closely anytime your child is in the presence of devices that might cause electromagnetic disturbances, including toys that use wireless or radio-controlled technology. If an unexpected change occurs, tell your child to move away from the potential source of interference. If the HeartAssist 5 LBSA VAD function does not immediately return to normal when the source is removed, contact your support team. Electrostatic discharge Testing has demonstrated that the HeartAssist 5 LBSA VAD has an acceptable risk regarding electrostatic discharge. However, children often come in close contact with television screens or computer monitors. Although this contact should not affect the operation of the HeartAssist 5 LBSA VAD, consider teaching your child to stay a safe distance from television screens and other sources of electrostatic discharge as an added measure of safety. Operating the HeartAssist 5 LBSA VAD system Chapters 4 6 explain how to operate and manage your childs HeartAssist 5 LBSA VAD system. The following additional information is specific to device management for the pediatric patient. As appropriate for his or her age, help your child to understand the device that is supporting his or her life; in particular, your child should understand that the Controller and other components of the system are not toys and should be handled carefully. Put precautions in place to minimize your childs ability to play with cables and connections. Teach your child to recognize alarms and to immediately go to you or another caregiver when an alarm occurs. If your child is too young to detect audible alarms reliably, ReliantHeart recommends that your child always be within hearing distance of you or another caregiver. If your child is old enough to participate in his or her care and to understand what to do, you should encourage your child to be responsible for changing batteries. Since the charge duration of the batteries varies according to the HeartAssist 5 LBSA VAD speed, you can only estimate the time interval between battery changes. If your child cannot change his or her batteries, you or another caregiver must always be available around the time that batteries must be changed. If you cannot reasonably estimate the battery charge duration, keep your child within hearing distance so that you can detect the battery discharged alarm. You must make a rule with your child that he or she will always have two charged batteries in the battery pockets. The VADPAK might be large for your child. Adjust the shoulder strap so that the VADPAK fits securely on your child. If the weight of the VADPAK pulls on your childs shoulder, additional padding may be placed beneath the shoulder strap to reduce the force. Your child should be taught to keep the VADPAK closed at all times, except when changing a battery or checking the Controller. Batteries VADPAK 74 HeartAssist 5 VAD System Patient User's Manual Caution active children against upside-down maneuvers on jungle gyms or other apparatus because the VADPAK Insert might come loose from the VADPAK if the zippers are unzipped. Your child will almost certainly get the VADPAK dirty. You can wipe the exterior of the bag with a slightly damp cloth to clean it, taking care not to get water inside the VADPAK. If your child would like, you can apply stickers to the exterior of the VADPAK, but nothing should be placed in the interior of the bag where equipment is placed. Because sand or dirt particles could easily get into the VADPAK and potentially interfere with connections, keep your child from sitting and playing in sand or dirt. Your childs VADPAK should be exposed to ambient air to allow proper cooling and to prevent the alarms from being muffled. Do not allow your child to wear the VADPAK beneath clothing for extended periods of time. Percutaneous cable The percutaneous cable connection to the Controller should be protected because it links the HeartAssist 5 LBSA VAD inside your childs chest to the equipment that runs that VAD on the outside of your childs body. Even though the HeartAssist 5 LBSA VAD is designed to prevent the cable from catching on objects and being pulled, you should make sure that your childs percutaneous cable is not prone to pulling or disconnection at any point while your child is active. Teach your child not to play with the percutaneous cable or its connection to the Controller because doing so might increase the risk of injury or infection at the exit site or disturb connections. Daily operation for the pediatric patient Daily operation on page 5-3 discusses the normal, daily use for both the HeartAssist 5 VAD (for adult patients) and the HeartAssist 5 LBSA VAD. The following subsections provide more information that is specific to children on HeartAssist 5 LBSA VAD support. Leaving the home Your child must have fully charged batteries whenever he or she leaves the house, and you or your child should always carry a spare Controller, spare battery pocket, and spare batteries. If your child will be away from home for extended periods of time, he or she must travel with an LVAD Battery Charger, reserve batteries, and an Independent Power Supply to charge his or her batteries and provide backup wall power. If you do not accompany your child, it is very important to teach him or her to carry the required backup equipment. Your child should also have a card, letter, bracelet, or other medical identification that shows that he or she has a HeartAssist 5 LBSA VAD left ventricular support device. This identification should also include your name or another caregivers name and a method of contact, as well as the name and phone number of your childs physician. Returning to school Some children return to school while on HeartAssist 5 LBSA VAD support. Before your child returns to school, the school nurse and classroom teacher or teachers should receive training in the management of your childs device. It is helpful to provide a copy of The HeartAssist 5 VAD System Patient User's Manual to school staff. You and your childs teachers should evaluate playground and classroom areas to identify any situations that might cause harm to your child or his or her device. ReliantHeart Confidential Patient and Heath Care Provider Use 75 It is useful to discuss your childs device with his or her classmates before he or she returns to school. Other children who play with your child should be cautioned not to pull your childs VADPAK, straps, or percutaneous cable during play. Classmates and playmates should be reminded to seek adult help as soon as possible if your child doesnt feel well or loses consciousness. While on HeartAssist 5 LBSA VAD support, your child may not participate in swimming or contact sports. This restriction is to protect the safety and function of your childs device. With the doctors permission, your child may participate in moderate activities like jogging, golfing, walking, shopping, and so forth with a low risk of harm to the device. Consult your doctor about whether or not your child may travel by car or plane. If your child requires a car seat during travel, you must position the VADPAK to eliminate pulling on the cables or on your childs shoulder. Seat belts should not interfere with travel for older children; however, children might be more comfortable riding on the right side of the vehicle where the belt buckles connect on the left side (because the percutaneous cable and VADPAK are located on the right side of the body). Activities Travel Sleeping When sleeping, your child should be tethered to the Independent Power Supply, which provides a continuous power supply and prevents the necessity of waking your child to change batteries. Arrange your childs room so that he or she can take the VADPAK off while sleeping, yet keep it close by so that the percutaneous cable connection is not stretched. You should put things your child might need at night in Showering and cleansing Children supported by the HeartAssist 5 LBSA VAD may not take a bath because the VADPAK, VADPAK Insert, Controller, battery pockets, and batteries would be fully submerged in water. Careful sponge baths are suggested in children not yet old enough to shower. If your child showers with the device, the VADPAK Insert must be fully enclosed in the shower bag as described in the section Showering with the VADPAK Insert and shower bag on page 5-6. Emergencies An emergency situation can be caused by medical conditions or by mechanical problems that interfere with the pumping ability of the HeartAssist 5 LBSA VAD. You and your child must learn how to identify and respond to emergencies. The most important action is to restore power and function to your childs HeartAssist 5 LBSA VAD. Local emergency services Local emergency services should be briefed about your childs HeartAssist 5 LBSA VAD, and you should have a plan established with your family to activate these emergency services when needed. 76 HeartAssist 5 VAD System Patient User's Manual CPR and defibrillation If defibrillation is required, your child can be connected either to battery power, the HeartAttendant, or the Independent Power Supply. Children on HeartAssist 5 LBSA VAD support can receive cardiopulmonary resuscitation (CPR). You might not be able to feel your childs pulse even if the HeartAssist 5 LBSA VAD is operating normally, so CPR and defibrillation should not be performed if your child is awake and responsive, even if a pulse is not apparent. Power outages If your childs current location loses power, and you are not certain when it will be restored, you must temporarily move your child to a location with power as soon as possible to prevent the HeartAssist 5 LBSA VAD from stopping. Bring your childs Independent Power Supply, LVAD Battery Charger, and reserve batteries with you and your child to the new location. Prevention Prevention is the key to handling emergencies with children on HeartAssist 5 LBSA VAD support, especially children who are old enough to sometimes be without a parent or caregiver. Your child should always carry identification as a left ventricular assist device patient with contact information for the caregiver and physician. Your childs teachers, coaches, classmates, friends, and siblings should be educated about the HeartAssist 5 LBSA VAD and taught what to do in the case of emergency. If your child is not with you, he or she should be accompanied by a responsible person such as a friend or an older sibling, so that someone is available to immediately seek help for your child in the case of an emergency. Children who are too young or unable to respond to device alarms, change batteries, or seek help should always be accompanied by a parent, other caregiver, or an individual knowledgeable in the operation of the HeartAssist 5 LBSA VAD. ReliantHeart Confidential Patient and Heath Care Provider Use 77 78 HeartAssist 5 VAD System Patient User's Manual Appendix A Troubleshooting In this appendix Emergencies ................................................................................................................................. A-2 Controller troubleshooting ............................................................................................................. A-3 Non-VAD related troubleshooting ................................................................................................. A-6 ReliantHeart Confidential Patient and Heath Care Provider Use A1 Emergencies Emergency situations can be caused by medical conditions or by mechanical problems that interfere with the pumping ability of the HeartAssist 5 VAD. You must learn how to identify and respond to emergencies. The most important action is to restore power and function to the HeartAssist 5 VAD. You or your caregiver must call 911 or the local emergency number when any of the following symptoms occur:
Loss of consciousness Seizures or convulsions Inability to move or speak Sudden collapse If you lose AC power, ensure that fully charged batteries are installed in the battery pockets, disconnect the Controller from the Independent Power Supply, and travel to the nearest source of correct AC power with the Independent Power Supply, reserve batteries, and the LVAD Battery Charger. A2 HeartAssist 5 VAD System Patient User's Manual Controller troubleshooting Table A-1 describes troubleshooting for alarm messages displayed on the Controller LCD. For examples of these messages, see Emergency alarms on page B-4 and Diagnostic alarms on page B-6. Table A-1. Troubleshooting guide for Controller alarms Alarm or error PUMP STOPPED alarm Associated event The VAD has stopped. The Controller automatically tries restarting nine times within approximately 60 seconds. The LCD alternates between PUMP STOPPED and PUMP RESTARTING while restarting. Troubleshooting If the first three methods fail to restart the VAD, you can force the VAD to restart by removing both batteries and re-inserting one battery into a battery pocket while not tethered to wall power as described in Manual VAD restart below. Check for flashing alarms, which can indicate why the VAD has stopped. For example: VAD DISCONNECTED or BOTH BATTERIES DISCONNECTED. Check for system damage. Attempt to verify that an unknown electrical disturbance is not affecting the Controller by moving to another location. See Emergency alarm 1: PUMP STOPPED on page B-4. Manual VAD restart If the VAD did not restart, perform the manual restart procedure described below:
1. Disconnect the battery pockets from any external power source. 2. Briefly remove both batteries from the battery pockets. 3. Re-insert one of the batteries into one of the battery pockets. This procedure activates the restart algorithm, which triggers an additional nine automatic restart attempts. If the VAD does not restart, continue with step 4. If the VAD restarts, disregard the remaining steps. When the VAD restarts, the emergency alarm clears. If the VAD does not restart after you have performed the manual restart procedure, replace the Controller with the backup Controller. 4. 5. Contact emergency medical services and your support team. The impeller and the motor Controller can occasionally lose synchronization. When this event occurs, the LCD displays the PUMP STOPPED then PUMP RESTARTING alarms, then it returns to the default display (assuming no other alarms are present). The audible emergency alarm does not sound for this event, but the event memory is captured. The resynchronization event typically allows the VAD to stop for approximately two seconds. PUMP RESTARTING alarm The VAD is attempting to restart. 1. See Diagnostic alarm 4: PUMP RESTARTING on page B-7. 2. Contact your support team. ReliantHeart Confidential Patient and Heath Care Provider Use A3 Alarm or error REDUCED FLOW RATE alarm EXCESS CURRENT alarm Fail-safe LED display frozen No display BOTH BATTERIES DISCONNECTED alarm Associated event The flow rate measured by the implanted flow probe has dropped below the programmed alarm threshold. The VAD is drawing current in excess of the programmed alarm threshold. The fail-safe LED is lit, the Controller is emitting a high-pitched continuous alarm, the LCD display is frozen, and the battery LEDs are lit. The VAD is running at the last set speed. The LCD is off, the LEDs are off, and the Controller is emitting a high-pitched continuous emergency alarm. The Controller has failed internally. Due to potential processor failure, no display is associated with this alarm. Both batteries are disconnected. If the emergency alarm clears, the batteries are connected; disregard further steps. If the alarm does not silence, continue with step 5. VAD DISCONNECTED alarm The VAD has become disconnected from the Controller. Troubleshooting Contact your support team. Contact your support team. 1. Replace the Controller with the backup Controller. 2. Contact your support team. 1. Replace the Controller with the backup Controller immediately. 2. Contact your support team. 1. Verify that all batteries are fully seated into the battery pockets. 2. Verify that the battery pocket connectors are correctly inserted into the Controller connectors. 3. Verify that the battery pocket cables are not cut or damaged. 4. Verify that at least one of the batteries is charged. 5. Replace the Controller with the backup Controller. 6. Contact your support team. 1. Verify that the percutaneous cable is not damaged. 2. Unscrew the white defibrillation cover from the percutaneous cable. 3. Disconnect the driveline from the percutaneous cable and verify that the pins inside the VAD connector are straight and free from debris or liquid. 4. Plug the driveline connector back into the percutaneous cable ensuring that the driveline connector is fully seated with the percutaneous cable connector. If the emergency alarm silences, the VAD is running. If the VAD does not restart, and the message does not clear when the alarm silence button is pressed, replace the Controller with the backup Controller. 5. Screw the white defibrillation cover onto the driveline cable. 6. Contact emergency medical services and your support team. A4 HeartAssist 5 VAD System Patient User's Manual Alarm or error Continuous audible alarm Associated event The Controller is malfunctioning. REDUCED MOTOR SPEED alarm BATTERY 1 OR 2 DISCHARGED alarm BATTERY 1 OR 2 DISCONNECTED alarm The RPM of the VAD has fallen below the programmed alarm threshold. The battery in port 1 or 2 has discharged below 25%. Either battery 1 or 2 has been disconnected. BATTERY 1 OR 2 EXPIRED alarm The battery in port 1 or 2 has discharged below 15%, or the battery voltage is too low. Troubleshooting 1. You must seek immediate medical assistance if the VAD has stopped. 2. Replace the Controller with the backup Controller. 3. Contact your support team. Contact your support team. Replace the discharged battery with a charged battery. 1. Verify that the battery is firmly seated into the battery pocket. 2. Verify the battery plug is properly seated into battery port of alarm Controller. 3. If alarm does not clear, contact your support team. 1. Replace the expired battery with a charged battery. 2. If the battery expired alarm occurred prior to a battery discharged alarm for that battery, contact your support team for a replacement battery. ReliantHeart Confidential Patient and Heath Care Provider Use A5 Non-VAD related troubleshooting The following tables describe troubleshooting information for the HeartAssist 5 VAD System. Table A-2. Troubleshooting guide for non-VAD issues Situation or error The Controller LCD display is unreadable, the battery LEDs respond to battery changes, and the fail-safe mode LED is off. It is likely that the VAD is still running normally. The Controller LCD display is unreadable, the battery LEDs respond to battery changes, and the fail-safe mode LED is on (solid red). It is likely that the VAD is still running in fail-safe mode at the last set speed. Because the motor Controller is separate circuitry from the CPU, the VAD could continue to run in the event of a Controller failure. However, the circuitry that verifies the functionality of the CPU detects a failure in the CPU and sets the motor controller to the last set speed. The Controller LCD display is unreadable; the battery LEDs do not respond to battery changes. It cannot be determined whether or not the VAD is operational. The Controller is splashed with liquid. The Controller becomes soiled. The Controller becomes submerged in liquid. Troubleshooting 1. Verify the functionality of the battery LEDs by inserting and removing a fully charged battery into one of the battery ports while the other battery port contains a charged battery. If the LCD is not functional but the battery and fail-safe mode status indicators are still functional and you feel no adverse effects, the VAD is probably still functioning correctly. 2. Replace the Controller with the backup Controller. 3. Contact your support team. 1. Replace the Controller with the backup Controller. 2. Contact your support team. 1. Replace the Controller with the backup Controller. 2. Contact your support team. Wipe the liquid from the case of the Controller. Wipe the Controller with a slightly damp cloth with mild detergent (for example, dishwasher soap). Never spray water or detergent directly onto the Controller. Always apply water or detergent to a soft cloth, wring it out until just slightly damp, and wipe the Controller. 1. Replace the Controller with the backup Controller immediately. 2. Contact your support team. A6 HeartAssist 5 VAD System Patient User's Manual Situation or error A VADPAK with VADPAK Insert is submerged in liquid. A battery is submerged in liquid. Troubleshooting 1. Locate your backup Controller, backup battery pocket, a charged battery, and the Independent Power Supply. 2. Insert a charged battery into the backup battery pocket. 3. Power up and connect the Independent Power Supply to the backup battery pocket. 4. Connect the backup battery pocket to the backup Controller. Perform the Controller replacement with the backup. 5. Contact your support team. If the backup battery pocket and the Independent Power Supply are not available, do not disconnect the Controller. Try to drain liquid, and contact your support team immediately. You must always have extra batteries, a backup battery pocket, and a backup Controller. If the battery is in the battery pocket, replace both the battery pocket and battery with a backup battery pocket and a spare battery. If the battery is not in the battery pocket, do not attempt to use or recharge this battery. Do not attempt to use or recharge any battery that becomes submerged in liquid. Contact your support team for a replacement battery and battery pocket. ReliantHeart Confidential Patient and Heath Care Provider Use A7 Situation or error An external power source, such as the Independent Power Supply (IPS), is connected to the battery pocket external power connector, but the power source is not indicated on the Controller display. Troubleshooting 1. Verify that the connector cable is correctly inserted in the battery pocket connector. If the Controller display does not indicate that the IPS or APS is connected, continue with steps 25. 2. Using the Controller display, check the battery status for both battery pocket batteries to ensure adequate charge levels. See Figure B-1 on page B-2. 3. With the IPS or APS connected to the battery pocket, disconnect the battery pocket from the Controller. See Disconnecting from the Independent Power Supply on page 5-4. 4. Press the Alarm Silence button on the Controller front panel. If you do not press the Alarm Silence button on the sounds, notifying you that it is disconnected. 5. Disconnect the IPS or APS from the battery pocket connector, and connect the IPS or APS directly into the Controller connector. You can damage the connectors if you force them without proper alignment. Do not twist the connectors while inserting them after the connectors are aligned. If the Controller front panel displays the external power indicator (a plug symbol), the battery pocket external power connector is malfunctioning. Replace the battery pocket with a backup battery pocket, and contact your support team for a replacement. If the Controller front panel is not displaying the external power indicator, the IPS or APS is malfunctioning. Reconnect the battery pocket, and contact your support team for a replacement IPS or APS. A8 HeartAssist 5 VAD System Patient User's Manual Appendix B Controller Messages and Alarms In this appendix Standard message screens .......................................................................................................... B-2 Emergency alarms ........................................................................................................................ B-4 Emergency alarm 1: PUMP STOPPED ........................................................................... B-4 Emergency alarm 2: BOTH BATTERIES DISCONNECTED ........................................... B-5 Emergency alarm 3: VAD DISCONNECTED .................................................................. B-5 Diagnostic alarms .......................................................................................................................... B-6 Diagnostic alarm 1: EXCESS CURRENT ........................................................................ B-6 Diagnostic alarm 2: REDUCED FLOW RATE ................................................................. B-7 Diagnostic alarm 3: REDUCED MOTOR SPEED ............................................................ B-7 Diagnostic alarm 4: PUMP RESTARTING ...................................................................... B-7 Diagnostic alarm 5: BATTERY 1 DISCONNECTED ........................................................ B-8 Diagnostic alarm 6: BATTERY 1 DISCHARGED ............................................................ B-8 Diagnostic alarm 7: BATTERY 1 EXPIRED ..................................................................... B-9 Diagnostic alarm 8: BATTERY 2 DISCONNECTED ........................................................ B-9 Diagnostic alarm 9: BATTERY 2 DISCHARGED ..........................................................B-10 Diagnostic alarm 10: BATTERY 2 EXPIRED .................................................................B-10 Controller failure alarms ..............................................................................................................B-11 Controller failure alarm 1: fail-safe alarm .......................................................................B-11 Controller failure alarm 2: Controller failure alarm .........................................................B-12 ReliantHeart Confidential Patient and Heath Care Provider Use B1 Standard message screens Battery 1 Percent Charge Remaining Battery 1 Charge Time Remaining hh:mm Battery 1 Percent Charge Remaining Battery 1 Charge Time Remaining hh:mm VAD Motor Power in WATTS, 0 24 W The Controller has seven standard message screens that continuously display information while scrolling with the Scroll Display button. Figures B-1 B-6 display the seven messages shown on the Controller. Figure B-1. Standard message screen 1: battery status Using battery power Battery 2 Percent Charge Remaining Battery 2 Charge Time Remaining hh:mm Battery 2 Percent Charge Remaining Battery 2 External Power Indicator Using external power Figure B-2. Standard message screen 2: current VAD parameters Flow rate in liters per minute VAD Speed (kRPM) 7.5 kRPM to 12.5 kRPM When the system is plugged in to external AC or DC power (for example with the Independent Power Supply), the battery charge time remaining that is displayed in standard message screen 1 is replaced by the external power indicator (a plug symbol), as shown in Figure B-1. B2 HeartAssist 5 VAD System Patient User's Manual Figure B-3. Standard message screen 3: wireless antenna status Wireless Antenna Enabled Wireless Antenna Disabled Wireless Antenna Disabled with Adjust Controls Figure B-4. Standard message screen 4: flow probe received amplitude Flow Probe Received Amplitude:
A & B Channels 1 - 5 Volts Figure B-5. Standard message screen 5: flow sensor status Flow Probe/Meter ENABLED or DISABLED Figure B-6. Standard message screen 6: battery capacity Battery 1 and 2 Capacity Remaining in Milliamp Hours
(mAh) ReliantHeart Confidential Patient and Heath Care Provider Use B3 Figure B-7. Standard message screen 7: not used Emergency alarms The following subsections describe emergency alarms. The Controller indicates an emergency alarm with a fast, loud, two-tone ringing sound. Emergency alarm 1: PUMP STOPPED The VAD has stopped. The Controller immediately activates the restart algorithm for approximately 60 seconds. The LCD alternates between PUMP STOPPED and PUMP RESTARTING while the restart algorithm is activated. If the pump successfully restarts, the emergency alarm automatically clears. Example Figure B-8 displays an example of emergency alarm 1, PUMP STOPPED. This alarm indicates that the VAD is not running. Figure B-8. Emergency alarm 1: PUMP STOPPED PUMP STOPPED User response If the PUMP STOPPED alarm displays, take the following actions:
1. Allow the automatic restart algorithm to complete its cycle (within 60 seconds). 2. If the VAD does not restart automatically after 60 seconds, perform the following manual restart procedure:
a. Disconnect the battery pockets from any external power sources (such as the Independent Power Supply). b. Briefly remove both batteries from the battery pockets. c. Re-insert one of the batteries into one of the battery pockets. B4 HeartAssist 5 VAD System Patient User's Manual 3. This procedure activates the restart algorithm, which triggers an additional nine automatic restart attempts. If the VAD does not restart after performing the manual restart procedure, replace the Controller with the backup Controller. 4. Contact your support team immediately. Emergency alarm 2: BOTH BATTERIES DISCONNECTED The Controller is not receiving power from either of the batteries. Example Figure B-9 displays an example of emergency alarm 2, BOTH BATTERIES DISCONNECTED. This alarm indicates that either the batteries are not properly inserted in the battery pockets, the cables connecting the battery pockets and Controller are not secure or are damaged, or that the Controller is malfunctioning. The VAD is not running when this alarm is present. Figure B-9. Emergency alarm 2: BOTH BATTERIES DISCONNECTED BOTH BATTERIES DISCONNECTED User response If the BOTH BATTERIES DISCONNECTED alarm displays, take the following actions:
1. Confirm that both batteries are properly inserted into the battery pockets. 2. Verify all cable connections. 3. If the VAD does not start, and the alarm does not clear automatically, replace the Controller with the backup Controller. This alarm clears automatically when the VAD restarts. A Controller that is not receiving power alarms for approximately three minutes. This alarm cannot be silenced. Emergency alarm 3: VAD DISCONNECTED The VAD is not connected to the Controller. Example Figure B-10 displays an example of emergency alarm 3, VAD DISCONNECTED. This alarm indicates that the VAD is not running and is not connected to the Controller. Figure B-10. Emergency alarm 3: VAD DISCONNECTED ReliantHeart Confidential Patient and Heath Care Provider Use B5 VAD DISCONNECTED User response If the VAD DISCONNECTED alarm displays, take the following actions:
1. Unscrew the white defibrillation cover from the driveline cable. 2. Verify and, if necessary, reconnect the driveline cable to the Controller. 3. Verify that the VAD has restarted successfully. 4. If VAD does not restart, and the alarm does not clear automatically, replace the Controller with the backup Controller. 5. Contact your support team immediately. Diagnostic alarms The following subsections describe diagnostic alarms. The Controller indicates a diagnostic alarm with a slow beeping sound. Diagnostic alarm 1: EXCESS CURRENT The VAD is drawing current in excess of the programmed alarm threshold. This alarm does not silence or clear automatically. Press the Controller Alarm Silence button to clear this alarm. Example Figure B-11 displays an example of diagnostic alarm 1, EXCESS CURRENT. Figure B-11. Diagnostic alarm 1: EXCESS CURRENT EXCESS CURRENT User response If the EXCESS CURRENT alarm displays, contact your support team immediately. B6 HeartAssist 5 VAD System Patient User's Manual Diagnostic alarm 2: REDUCED FLOW RATE The flow rate measured by the implanted flow probe has decreased below the programmed alarm threshold. This alarm does not silence or clear automatically. Press the Controller Alarm Silence button to clear this alarm. Example Figure B-12 displays an example of diagnostic alarm 2, REDUCED FLOW RATE. Figure B-12. Diagnostic alarm 2: REDUCED FLOW RATE REDUCED FLOW RATE User response If the REDUCED FLOW RATE alarm displays, contact your support team immediately. Diagnostic alarm 3: REDUCED MOTOR SPEED The speed (RPM) of the VAD has fallen below the programmed alarm threshold. This alarm does not clear automatically. Press the Alarm Silence button to clear this alarm. Example Figure B-13 displays an example of diagnostic alarm 3, REDUCED MOTOR SPEED. Figure B-13. Diagnostic alarm 3: REDUCED MOTOR SPEED REDUCED MOTOR SPEED User response If the REDUCED MOTOR SPEED alarm displays, contact your support team immediately. Diagnostic alarm 4: PUMP RESTARTING The VAD has stopped and is attempting to restart. The message PUMP RESTARTING displays briefly during the restart attempt alternating with the PUMP STOPPED message. ReliantHeart Confidential Patient and Heath Care Provider Use B7 Example Figure B-14 displays an example of diagnostic alarm 4, PUMP RESTARTING. Figure B-14. Diagnostic alarm 4: PUMP RESTARTING PUMP RESTARTING User response If the PUMP RESTARTING alarm displays, take the following actions:
1. Every two to three seconds, press the Alarm Silence button on the Controller, and verify that the flow rate, RPM, and power are normal. See Figure B-2 on page B-2. If the alarm silences, the VAD has restarted successfully. 2. Contact your support team immediately. Diagnostic alarm 5: BATTERY 1 DISCONNECTED Battery 1 is disconnected from the battery pocket as indicated on the Controller with a blinking amber light and an audible diagnostic alarm. Example Figure B-15 displays an example of diagnostic alarm 5: BATTERY 1 DISCONNECTED. Figure B-15. Diagnostic alarm 5: BATTERY 1 DISCONNECTED BATTERY 1 DISCONNECTED User response If the BATTERY 1 DISCONNECTED alarm displays, take the following actions:
1. Verify that the battery is firmly seated into battery pocket 1. 2. Verify that the battery pocket connector is firmly inserted into the Controller connector for battery 1. This alarm clears automatically after you reconnect battery 1. If alarm does not clear, contact your support team. 3. Diagnostic alarm 6: BATTERY 1 DISCHARGED The battery plugged into battery pocket 1 has discharged below a 25% charge level, as indicated on both the Controller and the battery pocket with a blinking amber light and an audible diagnostic alarm. B8 HeartAssist 5 VAD System Patient User's Manual Example Figure B-16 displays an example of diagnostic alarm 6, BATTERY 1 DISCHARGED. Figure B-16. Diagnostic alarm 6: BATTERY 1 DISCHARGED BATTERY 1 DISCHARGED User response If the BATTERY 1 DISCHARGED alarm displays, take the following actions:
1. Replace the battery in battery pocket 1 with a fully charged battery. 2. Recharge the discharged battery. This alarm clears automatically when you replace the discharged battery with a charged battery. Diagnostic alarm 7: BATTERY 1 EXPIRED The battery plugged into battery pocket 1 has discharged below 15%, or its voltage is too low, as indicated on both the Controller and battery pocket with a blinking amber light and an audible diagnostic alarm. Example Figure B-17 displays an example of diagnostic alarm 7, BATTERY 1 EXPIRED. Figure B-17. Diagnostic alarm 7: BATTERY 1 EXPIRED BATTERY 1 EXPIRED User response If the BATTERY 1 EXPIRED alarm displays, take the following actions:
1. Replace the expired battery in battery pocket 1 with a fully charged battery. 2. Recharge the expired battery. This alarm clears automatically after you replace the expired battery with a charged battery. Diagnostic alarm 8: BATTERY 2 DISCONNECTED Battery 2 is disconnected from the battery pocket as indicated on the Controller with a blinking amber light and an audible diagnostic alarm. Example Figure B-18 displays an example of diagnostic alarm 8, BATTERY 2 DISCONNECTED. ReliantHeart Confidential Patient and Heath Care Provider Use B9 Figure B-18. Diagnostic alarm 8: BATTERY 2 DISCONNECTED BATTERY 2 DISCONNECTED User response If the BATTERY 2 DISCONNECTED alarm displays, take the following actions:
1. Verify that the battery is firmly seated into battery pocket 2. 2. Verify that the battery pocket connector is firmly inserted into the Controller connector for battery 2. This alarm clears automatically after you reconnect battery 2. Diagnostic alarm 9: BATTERY 2 DISCHARGED The battery plugged into battery pocket 2 has discharged below a 25% charge level, as indicated on both the Controller and the battery pocket with a blinking amber light and an audible diagnostic alarm. Example Figure B-19 displays an example of diagnostic alarm 9, BATTERY 2 DISCHARGED. Figure B-19. Diagnostic alarm 9: BATTERY 2 DISCHARGED BATTERY 2 DISCHARGED User response If the BATTERY 2 DISCHARGED alarm displays, take the following actions:
1. Replace the battery in battery pocket 2 with a fully charged battery. 2. Recharge the discharged battery. This alarm clears automatically when you replace the discharged battery with a charged battery. Diagnostic alarm 10: BATTERY 2 EXPIRED The battery plugged into battery pocket 2 has discharged below 15%, or its voltage is too low, as indicated on both the Controller and the battery pocket with a blinking amber light and an audible diagnostic alarm. Example Figure B-20 displays an example of diagnostic alarm 10: BATTERY 2 EXPIRED. B10 HeartAssist 5 VAD System Patient User's Manual Figure B-20. Diagnostic alarm 10: BATTERY 2 EXPIRED BATTERY 2 EXPIRED User response If the BATTERY 2 EXPIRED alarm displays, take the following actions:
1. Replace the expired battery in battery pocket 2 with a fully charged battery. 2. Recharge the expired battery. This alarm clears automatically when you replace the expired battery with a charged battery. Controller failure alarms The following section describes alarms that occur when the Controller ceases to function. Controller failure alarms are indicated by a continuous tone. Controller failure alarm 1: fail-safe alarm The fail-safe LED is lit solid red, a high-pitch continuous alarm sounds, the LCD display is frozen, and battery LEDs are lit. The VAD continues to run at the last set speed. Example When this alarm sounds, the Controller continues to display the same screen that was present when the fail-safe alarm began to sound. Figure B-21. Controller failure alarm 1: fail-safe alarm (display frozen) FLOW SENSOR ENABLED The Controller screen is frozen to the last screen displayed before the alarm began to sound User response 1. Replace the Controller with the backup Controller. 2. Notify your support team of this event, and request a Controller replacement. ReliantHeart Confidential Patient and Heath Care Provider Use B11 Controller failure alarm 2: Controller failure alarm The LCD is off, the LEDs are off, and the Controller emits a high-pitch continuous alarm
(not a beeping alarm). The Controller has failed internally. The VAD has stopped. Example Figure B-22 displays an example of the Controller failure alarm. The Controller has a blank display when emitting this alarm. Figure B-22. Controller failure alarm 2: (no display) User response 1. Replace the Controller with the backup Controller immediately. 2. Notify your support team of this event immediately, and request a Controller replacement. B12 HeartAssist 5 VAD System Patient User's Manual Appendix C System Specifications In this appendix Introduction .................................................................................................................................. C-2 HeartAssist 5 VAD specifications .............................................................................................. C-2 Controller specifications ............................................................................................................... C-3 General specifications ..................................................................................................... C-3 Interface features ............................................................................................................ C-3 Safety features ................................................................................................................ C-3 Wireless antenna specifications ................................................................................................... C-4 HeartAttendant specifications .................................................................................................... C-4 General specifications ..................................................................................................... C-4 Safety features ................................................................................................................ C-4 Electrical specifications ................................................................................................... C-4 Replacement and accessory part list (fuses) .................................................................. C-5 VADPAK and VADPAK Insert specifications ............................................................................... C-5 Independent Power Supply .......................................................................................................... C-5 General specifications ..................................................................................................... C-5 Safety features ................................................................................................................ C-6 Electrical specifications ................................................................................................... C-6 Lithium ion battery ........................................................................................................................ C-6 General specifications ..................................................................................................... C-6 Safety features ................................................................................................................ C-6 Electrical specifications ................................................................................................... C-6 LVAD Battery Charger ................................................................................................................. C-7 General specifications ..................................................................................................... C-7 Electrical specifications ................................................................................................... C-7 Connecter cables, power cords, and fuses .................................................................................. C-7 Essential performance of the HeartAssist 5 VAD ...................................................................... C-8 ReliantHeart Confidential Patient and Heath Care Provider Use C1 Introduction This chapter presents information on the specifications for the HeartAssist 5 VAD System components. This chapter also presents information on the use of connecter cables and power cords, the proper replacement of fuses, and the essential performance of the HeartAssist 5 VAD. The service life of the Controller and all accessories is three years. HeartAssist 5 VAD specifications Table C-1 describes the general specifications of the HeartAssist 5 VAD. Table C-1. HeartAssist 5 VAD general specifications General property Weight (without cannula) Size Material Flow accuracy Range Specification 92 grams 30 mm x 76 mm Specific property VAD and internal components Titanium Bearings Ceramic Vascutek Gel Weave (with titanium ring) Graft Titanium, polyurethane, epoxy, polycarbonate Flow probe polyurethane Polycarbonate-polyurethane Ultra-high molecular-weight polyethylene 10% when flow > 3 L/min; 0.3 L/min when flow is
< 3 L/min 4.0 L/min to 10.0 L/min Percutaneous cable Graft protector C2 HeartAssist 5 VAD System Patient User's Manual Controller specifications The following subsections describe the properties of the Controller. General specifications Table C-2 describes the general specifications of the Controller. Table C-2. Controller general specifications Property Classification Ingress protection Weight Dimensions Programmed pump speed Battery type Power required Alarm sound pressure Specification Internally powered, type CF, defibrillation proof IP32 2.7 kg (6 lbs) (with two battery pockets & two batteries) 16.5 cm x 8.9 cm x 5.1 cm
(6.5 in x 3.5 in x 2.0 in) 7500 (200) to 12500 (200) RPM Lithium Ion (Li-ON) Range: 0 40 W 10%
60 80 db Interface features Patients, caregivers, and support staff use the Controller by interacting with the following features. Battery indicators Fail-safe and emergency mode indicator LED LCD display Programmable language Real-time clock Alarm Silence button Scroll Display button Battery status indicators Safety features The Controller includes the following features to ensure patient safety. Automatic fail-safe and emergency mode LED (with status) Automatic pump restart algorithm Automatic diagnostic tests at start-up Diagnostic visual and audible alarms Emergency visual and audible alarms Built-in data acquisition Patient information stored in nonvolatile memory ReliantHeart Confidential Patient and Heath Care Provider Use C3 Wireless antenna specifications You can use the wireless antenna in all markets where Quadband GSM (850/900/
1800/1900 MHz) is available. The wireless transmission of data is not a requirement for the Controller to fulfill its intended use or to meet its indications for use. HeartAttendant specifications The following subsections describe the HeartAttendant properties. General specifications Table C-3 describes the general specifications of the HeartAttendant. Table C-3. HeartAttendant general specifications Property Weight Dimensions External indicators External control Specification 11.34 kg (25 lbs) 55.88 cm x 48.25 cm x 45.72 cm (22 in x 19 in x 18 in) LED display Touch screen Safety features The HeartAttendant includes the following features to ensure patient safety. Fault tolerant operating system 5,000 volt defibrillation protection Password protection to VAD controls and operating system Electrical specifications Table C-4 describes the HeartAttendant electrical specifications. Table C-4. HeartAttendant electrical specifications Property Input voltage Maximum current Equipment type EMI/RFI Operation Specification 120/240 VAC 60/50 Hz 3.0/1.5 A Type CF, defibrillation proof, Class 1 Class A device Continuous duty C4 HeartAssist 5 VAD System Patient User's Manual Replacement and accessory part list (fuses) Table C-5 lists the HeartAttendant replacement and accessory parts and their part numbers. See Connecter cables, power cords, and fuses for instructions on obtaining replacement fuses. Table C-5. HeartAttendant part list Part description Fuse (US) Fuse (Europe) Part number 5 x 20 mm 120 V / 4 AMP slow blow 5 x 20 mm 240 V / 3 AMP slow blow VADPAK and VADPAK Insert specifications Table C-6 describes VADPAK and VADPAK Insert properties. Table C-6. VADPAK specifications Property VADPAK Bag Weight Dimensions Materials VADPAK Insert Weight Dimensions Materials Specification 1.81 kg (4.0 lb) (with batteries, battery pockets and controller) 27.94 cm x 10.16 cm x 21.59 cm (11 in x 4.0 in x 8.5 in) Cordura 500D Black, Cordura 500D Foliage, Soft Tex Skid Resistant 1.81 kg (4 lb) (with batteries, battery pockets and controller) 25.4 cm x 20.32 cm x 17.78 cm (10 in x 8 in x 7 in) Cordura 500D Black, 0.125 Corrugated Plastic Independent Power Supply specifications The following subsections describe the Independent Power Supply properties. General specifications Table C-7 describes the general properties of the Independent Power Supply. Table C-7. Independent Power Supply general specifications Property Weight Dimensions External indicators Specification 0.45 kg (1 lb) 4.80 cm 12.07 cm 7.62 cm (1.89 in 4.75 in 3.00 in) Power indicator light (green LED) ReliantHeart Confidential Patient and Heath Care Provider Use C5 Property Ingress protection Specification IPX1 Safety features The Independent Power Supply includes output protection from short circuit and overload to ensure patient safety. Electrical specifications Table C-8 describes the Independent Power Supply electrical specifications. Table C-8. Independent Power Supply electrical specifications Property Input voltage Maximum voltage Equipment type EMI/RFI Operation Specification 90-264 VAC; 47-63 Hz; 60 W 13.5 Vdc; 4.3 A Type CF; Defibrillation proof; Class 1 Class B device Continuous duty Lithium ion battery specifications The following subsections describe the lithium ion battery properties. General specifications Table C-9 describes the general properties of the lithium ion battery. Table C-9. Lithium ion battery general specifications Property Weight Dimensions External indicators Charge percentage Charge time remaining Battery capacity a Specification 0.45 kg (1 lb) 14.05 cm 8.86 cm 2.00 cm (5.53 in 3.49 in 0.79 in) LED indicator icon (fuel gauge) Range: 0 100% 10%
Range: 0:00 7:30 hours 10%
Range: 6000a 7800 mAh 10%
Recommended battery replacement level specified by ReliantHeart. Safety features The lithium ion battery includes a discharge cutoff of 9.0 V to ensure patient safety. Electrical specifications Table C-10 describes the lithium ion battery electrical specifications. Table C-10. Lithium ion battery electrical specifications C6 HeartAssist 5 VAD System Patient User's Manual Property Input voltage Maximum voltage Equipment type Operation Specification 10.8 V 4000 mA (under 30 C) 3000 mA (over 30 C) Type BF Continuous duty LVAD Battery Charger specifications The following subsections describe the LVAD Battery Charger properties. General specifications Table C-11 describes the general properties of the LVAD Battery Charger. Table C-11. LVAD Battery Charger general specifications Property Weight Dimensions External indicators External control Specification 0.71 kg (1.56 lb) 17.15 cm 11.05 cm 5.03 cm (6.75 in 4.35 in 1.98 in) LED indicators (green and amber) Recalibration button Electrical specifications Table C-12 describes the LVAD Battery Charger electrical specifications. Table C-12. LVAD Battery Charger electrical specifications Property Input voltage Maximum current Equipment type EMI/RFI Operation Specification 18 VDC 1.8 A Type BF, Class III Class III Intermittent duty Connecter cables, power cords, and fuses Only use ReliantHeart-supplied power cords and connecter cables with the HeartAssist 5 VAD System. Contact ReliantHeart to obtain the proper replacement power cords or connecter cables for your geographical area. Ensure appropriate fuse usage by obtaining replacement fuses from ReliantHeart. See Customer support on page iii for contact information. ReliantHeart Confidential Patient and Heath Care Provider Use C7 Essential performance of the HeartAssist 5 VAD The HeartAssist 5 VAD operates, without stoppage, at the preset speed. C8 HeartAssist 5 VAD System Patient User's Manual Appendix D Manufacturer Guidance for Environmental Conditions In this appendix Introduction .................................................................................................................................. D-2 Electromagnetic emissions .......................................................................................................... D-2 Electromagnetic immunity ............................................................................................................ D-2 Recommended separation distance between portable and mobile RF communications equipment and the Controller, HeartAttendant, battery pockets, Independent Power Supply, and batteries ................................................................................................................................. D-5 Requirements applicable to ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of their operation (60601-1-2, 5.2.2.5) ...................................................................................................................... D-6 Requirements applicable to ME EQUIPMENT and ME SYSTEMS that include RF transmitters (60601-1-2, 5.2.2.6) .............................................................................. D-7 FCC statements ........................................................................................................................... D-8 Statement according to FCC part 15.19 ......................................................................... D-8 Statement according to FCC part 15.21 ......................................................................... D-8 Statement according to FCC part 15.105 ....................................................................... D-9 R&TTE Declaration of Conformity ................................................................................................ D-9 ReliantHeart Confidential Patient and Heath Care Provider Use D1 Introduction The following sections outline the ReliantHeart manufacturers guidance and declarations for the components of the HeartAssist 5 VAD System. Electromagnetic emissions The HeartAssist 5 Controller, HeartAttendant, battery pockets, batteries, Independent Power Supply, and Controller connector cable are intended for use in the electromagnetic environment specified in Table D-1. The customer or the user of these components must ensure that they are used in such an environment. Table D-1. Electromagnetic emissions guidance and manufacturers declaration for all ME equipment and ME systems Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3 Compliance Group 1 Class B Class A Electromagnetic environmentguidance These components use RF energy only for their internal functions. Therefore, RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. These components are suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Complies Electromagnetic immunity The Controller, HeartAttendant, battery pockets, batteries, Independent Power Supply and Controller connector cable are intended for use in the electromagnetic environment specified in Table D-2 and Table D-3. The customer or the user of these components must ensure that they are used in such an environment. Table D-2. Electromagnetic immunity guidance and manufacturers declaration for all ME equipment and ME systems Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/ burst IEC 61000-4-4 Surge IEC 61000-4-5 IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input/
output lines 1 kV line(s) to line(s) 2 kV line(s) to earth Compliance Electromagnetic environmentguidance 6 kV contact 15 kV air 2 kV for power supply lines 1 kV for input/
output lines 1 kV differential mode 2 kV common mode The relative humidity should be at least 10%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. D2 HeartAssist 5 VAD System Patient User's Manual Immunity test Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 IEC 60601 test level
<5% UTa
(>95% dip in UT) for 0.5 cycles 40% UT
(60% dip in UT) for 5 cycles 70% UT
(30% dip in UT)
<5% UT
(>95% dip in UT) for 5 sec 10 A/m Compliance Electromagnetic environmentguidance
<5% UT
(>95% dip in UT) for 0.5 cycles 40% UT
(60% dip in UT) for 5 cycles 70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec 60 A/m Mains power quality should be that of a typical commercial or hospital environment. If the user of this equipment requires continued operation during power mains interruptions, ReliantHeart recommends powering this equipment from an uninterruptible power supply (UPS) or a battery. Based on the compliance level of 60 A/m for power frequency magnetic field, the appropriate separation distance can be calculated based upon the current in the power risers using the following formula:
Where I is the maximum current in amperes in the mains cable, and r is the recommended minimum separation distance (in meters). An example for calculating the separation distance for a 100 power bus would be as follows:
r = r = In the example above, the recommended separation distance would be about 27 cm. a UT is the AC mains voltage prior to application of the test level. Table D-3. and Electrostatic Discharge >
< Radio Frequency Susceptibility (Radiated and Conducted) Immunity Test Radiated Susceptibility RTCA/DO-160F Section 20 Radiated Susceptibility RTCA/DO-160F section 20 Air Discharge RTCA/DO-160F Section 25 RTCA/DO 160F Test Level 20V/m 100 to 400 MHz Compliance Yes 150V/m 400 MHz to 8 GHz 15kV Yes Yes Compliance indicates that the device did not malfunction while subjected to the listed test levels. ReliantHeart Confidential Patient and Heath Care Provider Use D3 Table D-4. Electromagnetic immunity guidance and manufacturers declaration for all life supporting ME equipment and ME systems Immunity test IEC 60601 test level Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz Outside ISM bandsa 10 Vrms 150 kHz to 80 MHz in ISM bandsa 10 V/ m 80 MHz to 2.5 GHz Compliance Electromagnetic environmentguidance 3 V 10 V 10 V/ m 80 MHz to 400 MHz 20 V/ m 400 MHz to 3.5 GHz Portable and mobile RF communications equipment should be used no closer to any part of this equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance
1.2
1.2
1.2
1.2
0.6
1.2 Recommended Separation Distance Recommended Separation Distance: 80 MHz to 400 MHz Recommended Separation Distance: 400 MHz to 800 MHz Recommended Separation Distance: 800 MHz to 3.5 GHz Recommended Separation Distance: 800 MHz to 3.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m).b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey c;
should be less than the compliance level in each frequency ranged. Interference can occur in the vicinity of equipment marked with the following symbol:
a b The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 27,957 MHz to 27,283 MHz; and 40.66 MHz to 40.70 MHz. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. D4 HeartAssist 5 VAD System Patient User's Manual Immunity test IEC 60601 test level Compliance Electromagnetic environmentguidance c d No accurate theoretical prediction of field strength from fixed transmitters such as base stations for radio, cellular and cordless telephones, land mobile radios, amateur radios, AM and FM radio broadcasts, and TV broadcasts is possible. To assess the electromagnetic environment due to fixed RF transmitters, consider an electromagnetic site survey. If the measured field strength in the location in which this equipment is used exceeds the applicable RF compliance level listed in Table D-3, observe the equipment to verify normal operation. If you observe abnormal performance, additional measures might be necessary, such as reorienting or relocating this equipment. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. At 400 MHz and 800 MHz, the higher frequency range applies. These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Recommended separation distance between portable and mobile RF communications equipment and the Controller, HeartAttendant, battery pockets, Independent Power Supply, and batteries This equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile communications equipment (transmitters) and this equipment as recommended in Table D-4, according to the maximum output power of the communications equipment. Table D-5. Recommended separation distance between portable and mobile RF communications equipment and the life-supporting ME equipment and ME systems Rated maximum output power of transmitter W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 150 kHz to 80 MHz outside ISM bands
. 150 kHz to 80 MHz in ISM bands
. 80 MHz to 400 MHz
. 400 MHz to 800 MHz
. 800 MHz to 3.5 GHz
. 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.06 0.19 0.6 1.9 6 0.12 0.38 1.2 3.8 12 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to ReliantHeart Confidential Patient and Heath Care Provider Use D5 the frequency transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. At 400 MHz and 800 MHz, the separation distance for the higher frequency range applies. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz;
and 40.66 MHz to 40.70 MHz. An additional factor of 10/3 has been incorporated into the formula used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile or portable communications equipment could cause interference if it is inadvertently brought into patient areas. These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. The HeartAttendant is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the HeartAttendant can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HeartAttendant as recommended in Table D-4, according to the maximum output power of the communications equipment. Use of equipment and supplies other than those specified in this manual or sold by ReliantHeart for replacement parts could affect the electromagnetic compatibility of the HeartAssist 5 VAD with other devices, resulting in potential interference between the HeartAssist 5 VAD and other devices. The HeartAttendant must be kept at least one foot away from electrical appliances (such as kitchen appliances). Requirements applicable to ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of their operation (60601-1-2, 5.2.2.5) For ME EQUIPMENT and ME SYSTEMS that intentionally receive FR electromagnetic energy for the purpose of their operation, the ACCOMPANYING DOCUMENTS shall include the following information:
a. Each frequency or frequency band of reception; the preferred frequency or frequency band, if applicable, and the bandwidth of the receiving section of the ME EQUIPMENT or ME SYSTEM in those bands. The conquest controller may receive the following frequency ranges:
869.2 MHz to 894.2 MHz D6 HeartAssist 5 VAD System Patient User's Manual 935 MHz to 960 MHz 1805.2 MHz to 1879.8 MHz 1930.2 MHz to 1989.8 MHz For operation in North America, the conquest controller will be fitted with an antenna which is optimized to receive frequencies in the GSM 850 and GSM 1900 frequency bands which have a range of 869.2 to 894.2 MHz and 1930.2 to 1989.8 MHz. Use of equipment and supplies other than those specified in this manual or sold by ReliantHeart for replacement parts could affect the electromagnetic compatibility of the HeartAssist 5 VAD with other devices, resulting in potential interference between the HeartAssist 5 VAD and other devices. Requirements applicable to ME EQUIPMENT and ME SYSTEMS that include RF transmitters (60601-1-2, 5.2.2.6) For (Conquest Controller) ME EQUIPMENT and (VAD System) ME SYSTEMS that include RF transmitters, the ACCOMPANYING DOCUMENTS shall include each frequency or frequency band of transmission, the type and frequency characteristics of the modulation and the EFFECTIVE RADIATED POWER. RF Power Output 850MHz band Limit: FCC: Nominal Peak Output Power < 38.45 dBm (7W) IC: Nominal Peak Output Power < 40.60 dBm (11.5W) GSM Cellular 850 (GMSK Mode) Frequency (MHz) 824.2 836.6 848.8 Radiated Power ERP (dBm) 30.5 31.2 30.3 RF Power Output 1900MHz band Limit: Nominal Peak Output Power < 33 dBm (2W) GSM PCS 1900 (GMSK Mode) Frequency (MHz) 1850.2 1880.0 1909.8 Radiated Power EIRP (dBm) 29.1 29.3 27.7 The HeartAssist 5 VAD System has been tested and found to comply with IEC 60601-1-
2:2007 Medical Electrical Equipment - Part 1-2 General Requirements for Safety -
Collateral Standard: Electromagnetic Compatibility. This testing shows the device provides reasonable protection against interference in a typical medical installation. The HeartAssist 5 VAD can generate, use, and radiate radio frequency energy and, if not installed and used in accordance with the instructions, can cause interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause interference to other devices or is negatively impacted by other devices, the user is encouraged to attempt to correct the interference by one or more of the following measures:
Reorient or relocate devices. Increase the separation between devices. ReliantHeart Confidential Patient and Heath Care Provider Use D7 Connect the equipment to an outlet on a different circuit. Consult the manufacturer or technical support engineer for help. The HeartAssist 5 VAD System requires special precautions regarding electromagnetic compatibility (EMC), and you must install it and put it into service according to the EMC information provided in this appendix. Portable and mobile RF communications equipment can affect the HeartAssist 5 VAD System. FCC statements ReliantHeart has issued the following statements regarding the HeartAssist 5 VAD System wireless transmitter. The following FCC statements apply to Model: CTL002 FCC ID: 2AB4ZCTL002. Statement according to FCC part 15.19 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Statement according to FCC part 15.21 Modifications not expressly approved by, ReliantHeart could void the users authority to operate the equipment. D8 HeartAssist 5 VAD System Patient User's Manual Statement according to FCC part 15.105 This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Radio frequency radiation exposure information:
This phone has been tested and meets the FCC RF exposure guidelines for body worn operations with zero distance. It shall be used with the ReliantHeart accessories supplied or designated for this product and as documented within this manual. Use of other accessories may not ensure compliance with the FCC RF exposure guidelines. R&TTE Declaration of Conformity Hereby, ReliantHeart declares that the Controller is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. To obtain an English copy of the Declaration of Conformity, write to the address below:
ReliantHeart 8965 Interchange Drive Houston, TX 77054 ReliantHeart Confidential Patient and Heath Care Provider Use D9 D10 HeartAssist 5 VAD System Patient User's Manual Index A Accessories, 3-7 activity restrictions, 7-6 Activity restrictions, 5-8 Automatic restart, 4-6 B backup power, 5-3 bathing, 7-6 battery changing, 4-26 charging, 4-28 Battery pockets, 4-15 C controller Automatic fail-safe mode, 4-6 Battery indicators, 4-5 display, 4-3 Flow sensor, 4-5 messages and alarms, 4-4 replacement, 4-7 Replacing the SIM card, 4-12 safety check, 4-14 sounds, 4-4 Standard message screens, B-2 troubleshooting, A-3 VAD restart algorithm, 4-6 Wireless radio antenna, 4-5 Controller, 4-2 controller failure alarms Controller failure alarm, B-12 fail-safe alarm, B-11 CPR, 5-11 D Daily operation, 5-3 Daily status checks, 5-2 defibrillation, 5-11, 7-7 diagnostic alarms BATTERY 1 DISCHARGED, B-8 BATTERY 1 DISCONNECTED, B-8 BATTERY 1 EXPIRED, B-9 BATTERY 2 DISCHARGED, B-10 BATTERY 2 DISCONNECTED, B-9 BATTERY 2 EXPIRED, B-10 EXCESS CURRENT, B-6 PUMP RESTARTING, B-7 REDUCED FLOW RATE, B-7 REDUCED MOTOR SPEED, B-7 Documentation, 3-11 E electrical shock, avoiding, 4-2 Electromagnetic disturbances, 6-3 Emergencies, 5-11, 7-6, A-2 emergency alarms BOTH BATTERIES DISCONNECTED, B-5 PUMP STOPPED, B-4 VAD DISCONNECTED, B-5 emergency assistance, 1-2 Environmental conditions, 6-2 exit site, how to care for, 5-9 G graft protector, 3-4 I Independent Power Supply, 4-31 disconnecting, 5-4 ReliantHeart Confidential Patient and Heath Care Provider Use Index 1 LVAD Battery Charger, C-7 VAD, C-2 VADPAK, C-5 wireless antenna, C-4 specifications independent power supply, C-5 surgery pouch, 3-8 Symbols used in labeling, 3-8 System components, 3-3 T television screens, 7-4 tethered operation Independent Power Supply, 5-5 switching from unthethered operation, 5-5 Tethered operation, 5-3 U untethered operation switching to unthethered operation, 5-4 Untethered operation, 5-3 V VADPAK, 4-16 Connecting to external power, 4-21 Indications and contraindications for use, 3-2 L Leaving the home, 5-6 liquids, contact with, 6-3, 7-3 M Maintenance, 3-3 N no display, A-4 O outflow graft, 3-4 P pediatric patient daily operation, 7-5 percutaneous cable caring for, 5-10 securing to the showerbag, 5-7 Percutaneous cable, 7-5 Potential complications, 3-3 power cables, 4-2 outages, 5-11, 7-7 outlets, 4-2 Power supply, 4-22 prohibited activities, 7-6 pulse, 7-7 S separation distance, D-5 shower bag, 5-6 Showering, 5-6, 7-6 specifications controller, C-3 HeartAttendant, C-4 lithium ion batteries, C-6 2 Index HeartAssist 5 VAD System Patient User's Manual ReliantHeart Confidential Patient and Heath Care Provider Use Index-3
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2015-11-11 | 1852.4 ~ 1907.6 | PCB - PCS Licensed Transmitter | Original Equipment |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 | Effective |
2015-11-11
|
||||
| 1 | Applicant's complete, legal business name |
ReliantHeart Inc.
|
||||
| 1 | FCC Registration Number (FRN) |
0023477615
|
||||
| 1 | Physical Address |
8965 Interchange
|
||||
| 1 |
Houston, Texas 77054
|
|||||
| 1 |
United States
|
|||||
| app s | TCB Information | |||||
| 1 | TCB Application Email Address |
n******@cetecom.com
|
||||
| 1 | TCB Scope |
B1: Commercial mobile radio services equipment in the following 47 CFR Parts 20, 22 (cellular), 24,25 (below 3 GHz) & 27
|
||||
| app s | FCC ID | |||||
| 1 | Grantee Code |
2AB4Z
|
||||
| 1 | Equipment Product Code |
CTL002
|
||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 | Name |
B**** E**** L******
|
||||
| 1 | Title |
CTO
|
||||
| 1 | Telephone Number |
+1 71********
|
||||
| 1 | Fax Number |
+1 71********
|
||||
| 1 |
b******@reliantheart.com
|
|||||
| app s | Technical Contact | |||||
| n/a | ||||||
| app s | Non Technical Contact | |||||
| n/a | ||||||
| app s | Confidentiality (long or short term) | |||||
| 1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
| if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
| app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
| 1 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 | Equipment Class | PCB - PCS Licensed Transmitter | ||||
| 1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Controller for HeartAssist 5 Left Ventricular Assist Device | ||||
| 1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 | Modular Equipment Type | Does not apply | ||||
| 1 | Purpose / Application is for | Original Equipment | ||||
| 1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
| 1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
| 1 | Grant Comments | Output power listed is ERP for part 22 and EIRP for part 24 and part 27. This device contains functions that are not operational in U.S. Territories. This filing is only applicable for US operations. This device has been tested to be compliant with FCC RF exposure guidelines for body worn operation with zero distance. End users must be informed of the body worn requirements for satisfying RF Exposure compliance. The highest reported SAR for body-worn transmission use condition is 0.68 W/kg. | ||||
| 1 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
| app s | Test Firm Name and Contact Information | |||||
| 1 | Firm Name |
CETECOM Inc.
|
||||
| 1 | Name |
S**** S********
|
||||
| 1 | Telephone Number |
408-5********
|
||||
| 1 | Fax Number |
408 5********
|
||||
| 1 |
S******@cetecom.com
|
|||||
| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 22H | 824.2 | 848.8 | 0.75 | 2.5 ppm | 240KGXW | ||||||||||||||||||||||||||||||||||
| 1 | 2 | 22H | 824.2 | 848.8 | 0.25 | 2.5 ppm | 248KG7W | ||||||||||||||||||||||||||||||||||
| 1 | 3 | 22H | 826.4 | 846.6 | 0.08 | 2.5 ppm | 4M08F9W | ||||||||||||||||||||||||||||||||||
| 1 | 4 | 27 | 1712.4 | 1752.6 | 0.25 | 2.5 ppm | 4M06F9W | ||||||||||||||||||||||||||||||||||
| 1 | 5 | 24E | 1850.2 | 1909.8 | 0.89 | 2.5 ppm | 241KGXW | ||||||||||||||||||||||||||||||||||
| 1 | 6 | 24E | 1850.2 | 1909.8 | 0.56 | 2.5 ppm | 252KG7W | ||||||||||||||||||||||||||||||||||
| 1 | 7 | 24E | 1852.4 | 1907.6 | 0.23 | 2.5 ppm | 4M10F9W | ||||||||||||||||||||||||||||||||||
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC