Home

The HeartAssist 5 ® VAD System Patient User`s Manual

1. ssssssssssseeee 53 9 1 1 Before You Go To SIGOD eene tbe les tmd btt etu e pcdes etd 53 9 1 2 When You First Wake in the Morning omooooccocoononononnonconcnnnnonnnnnnncnnonanonananancnos 53 10 0 Daily Opera O era soie aerae Ded eod ea Deb ka acl Raus Eun ME ROTER dao a RE Fe VERRE 55 101 Tethered Operation tacon a 55 10 2 To Switch from Untethered to Tethered Operation ooonccccccnnniccccnonnccccconanannnnnnnancnnnnnncnnnos 55 10 2 1 Be Sure that the HeartAttendant is ready to be used ss 55 10 2 2 Connect the HeartAttendant Interface Cable to the External Interface goi M 56 10 3 Untethered Opera rores tr Eee erc e tee fe no deeu nde pea Ea anapeana aides 56 10 4 To Switch from Tethered to Untethered Operation ssne 57 10 4 1 Before Disconnecting From the HeartAttendant cs solis 57 10 4 2 Disconnecting the VADPAK From the HeartAttendant ss 57 10 5 When Away From the Residence seeeeesssseseseseeeeen nennen nennen nnne 57 O a minced ed ra 58 10 7 Using the VADPAK and Shower Bag eo eed bebe t 58 10 8 Activity Restrictions t rr s aeeamedecateasaederceaneeaces 60 10 9 NO KNOWN RISK cet Dc EC 60 MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual V 110 SOHC a Cr 61 11 1 Caring for the HeartAssist 59
2. MicroMed Cardiovascular Inc charging system i e the ChargePAK at all times The Fail Safe Dongle must be kept in the VADPAK The spare Controller spare Battery Pocket and Batteries must be accessible to the patient at all times Do not service this equipment yourself Only qualified personnel can service this equipment If ser vice is required contact your Support Team personnel When connecting the Controller to the HeartAttendant ensure that MAINS AC power is available and or fully charged Batteries are installed in the VADPAK battery pockets Ensure that the MAINS AC input voltage is appropriate for the local power source Do not use extension cords Damage can occur to the HeartAttendant VADPAK cable Controller ports or VADPAK port if the connector is forced without proper alignment DO NOT try to force a battery cable plug into the bat tery port on the Controller Verify the correct VADPAK cable plug is being inserted in the correct bat tery port on Controller and the red dots are aligned When removing the cable hold the connector and pull out DO NOT twist the battery plug while inserting or removing after the connectors are aligned Do not shower with the VADPAK without it being properly encased in the provided Shower Bag MicroMed Cardiovascular Inc Xiv The HeartAssist 5 VAD System Patient User s Manual MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 1 1 0
3. 7 1 Standard Messages Seven Scrolled Information Screens Default Screen 1 Flow Rate in Liters Per 4 0 L min 10 2W Minute B1 10096 B2 06596 VAD Power in Watts Percent Charge Remaining for Batteries 1 and 2 B1 and B2 5 S i ececnestec cte a MSS Figure 7 2 Default Screen 1 Default Screen 2 DATE TIME Month Day Year 02 14 97 24 Hour Clock S N 1234 REVD Controller Serial Number Figure 7 3 Default Screen 2 Default Screen 3 VAD Motor MOTOR CURRENT Current Amps 0 3 A to 2 0 A Figure 7 4 Default Screen 3 MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 39 Default Screen 4 MOTOR SPEED VAD Pump Speed kRPM 10 5 KRPM 7 5 KRPM to 12 5 kRPM Figure 7 5 Default Screen 4 Default Screen 5 RCVD AMPLITUDE Flow Probe Received Amplitude A amp B elm Bem Channels 1 to 5 Volts Figure 7 6 Default Screen 5 Default Screen 6 Flow Probe Meter FLOW SENSOR ENABLED OR ENABLED DISABLED Figure 7 7 Default Screen 6 MicroMed Cardiovascular Inc 40 The HeartAssist 5 VAD System Patient User s Manual Default Screen 7 Not Used Figure 7 8 Default Screen 7 7 2 Alarms The Controller has two distinctive audible sounds to help you determine the type of alarm The diagnostic alarm is a slower beeping sound The emergency alarm is a faster loud ringing 2 tone sound 7 2 4
4. 00 c eee 17 Figure 5 3 The VADPAK lt 4 sve ses ue a aaa eo 20 Figure 5 4 MADPAK Battery Bays 2 eise o xx RR PORRO ERR ole ts AR 20 Figure 5 5 Battery Connector Cables sso tA a e la RE 21 Figure 5 5 Battery Fastener ets pal es SOLE YR 22 Figure 5 7 Closed VADPAK Cover i v2 0 426044 px e rade P rx AC RE Fux da 22 Figure 5 8 External Interface Port Connection oooococooccooccno ees 23 Figure 5 9 Description of Components ooocoooccc eh 24 Figure 5 10 Internal Battery oscila ce suck ERES d ui Eu Oe YER 25 Figure 5 11 Attaching the White Defibrillation Insulator llle 25 6 0 HeartAttendant Figure 6 1 AC Power Setting ire obs rr dows eee gees ave ss bags EY 27 Figure 6 2 Connecting the Controller to the HeartAttendant as a Power Source 28 Figure 6 3 Batteries Seated in HeartAttendant Battery Slots 225 cx A eek 29 Figure 6 4 Battery Display Screen iie gece essa astral e oe E Ri wages ease 29 Figure 6 5 Patient Display Screen ovo ste rs Di eee eos 29 Figure 6 6 gt Alamm Status Barris a ee ee be E rte eet e oh oie 30 Figure 6 7 Status Display o NG ramet han o qoM da a e 30 Figure 6 8 Patient Display Screens Lidia e Reo eR ras er dodo Sha EN REL Rs 31 Figure 6 9 Alarm Status Bar with Sleep and Alarm History Buttons oooooccoooo oo 31 Figure 6 10 Alarm Status Bar with Sleep and Alarm History Buttons and Alarms Detected rat e E E ate en Me d a RP ur qai o EDO
5. Controller Cable VADPAK and Batteries Figure 3 1 The HeartAssist 5 VAD System You have the following components of this system Pump Implanted Inflow Cannula Implanted Flow Probe Implanted Outflow Graft Implanted Percutaneous Cable Partially Implanted MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual VADPAK and Batteries e Controller 3 2 The Pump The Pump is attached to a titanium inlet cannula that is placed in the left ventricle of the heart A Dacron graft is connected to the Pump outlet and attached to the aorta A three phase electric motor is integrated in the Pump and driven by the Controller The Pump is connected to the Controller via a Percutaneous Cable that is passed through the skin The Percutaneous Cable contains the Pump power cable and the flow probe cable The exit site is the area of your skin around which the Percutaneous Cable leaves your body Flow Graft HeartAssist 5 VAD Outflow Graft Probe Protector Inflow Cannula curved cannula depicted Percutaneous Sewing Cable Ring Hat Connector Percutaneous Dacron Cable Sheath Figure 3 2 Assembled HeartAssist 5 VAD Pump MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual Percutaneous Cable Connector Outflow Graft Sewing Hat Flow DeBakey Probe VAD Straight Pump Graft Protector Dacron Percutaneous Sheath Cable Figure 3 3 Assembled
6. The HeartAssist 5 VAD System Patient User s Manual Xi General Warnings and Precautions Warnings 1 13 14 15 16 Do not undergo an MRI Strong magnetic fields may affect device operation Do not use the HeartAttendant with ventricular assist devices other than the HeartAssist 5 VAD System Do not disconnect both Batteries at the same time The Pump will stop Do not disconnect the Pump from the Controller The Pump will stop Disconnect the Controller from the HeartAttendant before unplugging the HeartAttendant from the power source Disconnect the power cord from the power source before changing fuses Use only Batteries supplied by MicroMed Cardiovascular Inc Use only fuses supplied by MicroMed Cardiovascular Inc for the HeartAttendant Use only power cable s supplied by MicroMed Cardiovascular Inc Do not open the back cover of any MicroMed Cardiovascular Inc device Before leaving the hospital make sure the backup Controller has been preprogrammed to the same speed and alarm thresholds as the main Controller The HeartAttendant should not be used in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Do not operate the HeartAttendant where temperatures are less than 10 C 50 F or greater than 40 C 104 F Do not operate the Controller where temperatures are less than 10 C 14 F or greater than 40 C 104 F or where relative
7. operating parameters and alarm levels Each patient is issued a HeartAttendant upon implant and keeps the device for the duration of the implant 6 1 Connecting to the Power Source The AC power setting appropriate to the country of use has been preset for either North America 120VAC or Europe 240VAC 1 Check the AC power input on the side of the HeartAttendant to make sure that the power setting is appropriate See Figure 6 1 If the setting is not appropriate contact your support team AC Power Setting Figure 6 1 AC Power Setting 2 Plug the main power cord into the AC power input 3 Connect the plug to the AC power source The HeartAttendant screen should boot up to the Patient Display Screen within 40 seconds MicroMed Cardiovascular Inc 28 The HeartAssist 5 VAD System Patient User s Manual 4 Insert the Batteries into the battery compartments of the HeartAttendant 6 2 Using the HeartAttendant as a Power Source Follow the steps below to use the HeartAttendant as a power source for the Controller 1 Connect one end of the HeartAttendant Controller Interface Cable to the socket on the front of the HeartAttendant 2 Connect the other end of the cable to the External Interface Port of the VADPAK See Figure 5 8 on page 23 Figure 6 2 Connecting the Controller to the HeartAttendant as a Power Source 6 3 Recharging Batteries It is recommended that Batteries not being used in the V
8. Daily Checks Daily Checks Using the HeartAttendant Check your Controller your primary and reserve batteries and your HeartAttendant every day as described below Caution Contact your Support Team personnel if any of the Controller alarms are not working Every 2 3 hours when awake check the Battery status on the front panel of the Controller if not tethered to the HeartAttendant If tethered to HeartAttendant check Battery 2 status on Patient Display screen on HeartAttendant Pull Battery 1 from VADPAK to check LEDs 9 1 1 Before You Go To Sleep Before you go to sleep check the following things Verify that you have two fully charged Batteries in your VADPAK e Verify that the HeartAttendant is supplying power to the Controller by checking that the Battery LED on your Controller s front panel is green for the battery port connected to the HeartAttendant The Controller front panel will read DAS CONNECTED 9 1 2 When You First Wake in the Morning When you first wake in the morning check the front panel of the Controller and HeartAttendant Patient Display screen for lighted symbols and messages If there are alarm messages see Section 7 0 The Controller Front Panel Display Alarms and Troubleshooting of this manual to find out how to handle them MicroMed Cardiovascular Inc 54 The HeartAssist 5 VAD System Patient User s Manual MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Pati
9. ERR 31 Figure 6 11 Alarm Status Bar with Sleep and Alarm History Buttons and Emergency Alarms Detected x su veau e un s 1 ISSUE ae POUR tee A oe 32 Figure 6 12 Current Alarms and Alarm History Window 000 0c eee eee eee 32 Figure 6 13 Acknowledge Controller Alarms button illie 33 Figure 6 14 Sleep Mode Display 0 000 re 34 Figure 6 15 Battery Display Screen erica pene reg ERES eo REQUE eae eed E RE 34 Figure 6 16 Mains Input Socket on the Rear Panel of the HeartAttendant 35 Figure 6 17 Fuse block in power inlet module 060 cece cee eee ee eR ene 36 MicroMed Cardiovascular Inc viii The HeartAssist 5 VAD System Patient User s Manual 7 0 The Controller Front Panel Display Alarms and Troubleshooting Figure 7 1 Figure 7 2 Figure 7 3 Figure 7 4 Figure 7 5 Figure 7 6 Figure 7 7 Figure 7 8 Figure 7 9 Figure 7 10 Figure 7 11 Figure 7 12 Figure 7 13 Figure 7 14 Figure 7 15 Figure 7 16 Figure 7 17 Figure 7 18 Figure 7 19 Figure 7 20 Figure 7 21 Figure 7 22 Figure 7 23 Figure 7 24 Figure 7 25 Controller Front Panel epo RN O E woe e ee s 37 Detaul Sereen tesis aia e a RU a 38 Default Screen 2 ners rars wines RT ERGO exer a nA SR ANO Rag wipes 38 Default Screen os oia ia ara pete Ge ag dee dress Ui boost qa n he Gee ova 38 Default Screen usse cp ERU ee eee a NR irn t 39 Defa lt Screen an Ac ui ee ru Bei odia eh Mop e
10. Emergency Alarms Emergency Alarm 1 The VAD Pump has stopped The Controller immediately activates the restart algorithm for approximately 60 sec PUMP STOPPED onds LCD alternates between PUMP STOPPED and PUMP RESTARTED while restart algorithm is activated Note If the pump successfully restarts the Figure 7 9 Emergency Alarm 1 emergency alarm will automatically clear ACTION TO BE TAKEN e Contact the Support Team immediately f pump does not start and message does not clear when Alarm Silence Button of the Controller is pressed replace the Controller with backup Controller Note The impeller and motor may occasionally lose synchronization stop then restart When this occurs the LCD displays PUMP STOPPED then PUMP RESTARTED then clears these alarms and returns to the default display assuming no other alarms are present The audible emergency alarm is not sounded for this event but the Holter memory is captured and the HeartAttendant alarm history is triggered The resynchronization event typically allows the Pump to be stopped approximately 2 MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 41 Emergency Alarm 2 BOTH BATTERIES ACTION TO BE TAKEN Emergency Alarm 3 Plug a recharged Battery into the VADPAK or a DISCONNECTED battery pocket Verify VADPAK k k laces Bi battery pocket cables are plugged into Figure 7 10 Emergency Alarm 2 If pump doe
11. Manual 3 2 0 Introduction to the HeartAssist 5 VAD You and your doctor have chosen to use the HeartAssist 59 VAD to help support your body s circulation Since your heart cannot pump well enough to adequately circulate the blood theHeartAssist 59 VAD will assist the pumping function of the left ventricle the main pumping chamber of the heart This manual gives you and any caregiver information about the HeartAssist 59 VAD explaining how it works and how to care for the system Your technical and clinical support staff have detailed manuals to supplement the Patient User s Manual The SE 5 Pis System npo og d Ls fini bnt qui UB PA BUD as ose one 1 the Pump System 2 the VADPAK that contains the Controller and Batteries and 3 the HeartAttendant 2 1 2 2 The Pump System The Pump System is implanted and consists of the following components Pump Inflow Cannula Flow Probe Outflow Graft e Percutaneous Cable The inflow cannula is inserted in the left ventricle of the heart and carries the blood to the Pump The outflow graft is attached to the aorta and carries blood away from the Pump to the aorta A three phase electric motor is integrated in the Pump and driven by the Controller The Pump is connected to the Controller via a Percutaneous Cable that is passed through the skin The Percutaneous Cable contains the three phase Pump power cable and the flow probe cable The Controller The Controller
12. Overview This manual gives you and your caregiver the information that you will need to use and care for the HeartAssist 5 VAD System lt covers normal use and also explains how to handle emergencies Please read the entire manual before using the HeartAssist 59 VAD System without supervision Unless otherwise specified HeartAssist 5 VAD refers to the curved inflow eannula the straightinflew cannula HearAssist 5 Straight VAD and the pediatric VAD HeartAssist 59 Pediatric VAD designs Following is a brief description of the kind of information you will find in each section For more information go to the appropriate section Preface Section 1 Section 2 Section 3 Section 4 Section 5 Section 6 General Warnings and Precautions What are some general things that should know about my device When should call for help Overview How is the manual arranged What information is presented in each section Introduction to the HeartAssist 50 VAD Why do need the HeartAssist 5 VAD System What does it do Description of HeartAssist 5 VAD System What are the names of the parts of the HeartAssist 59 VAD System What do they look like Environmental Conditions What kind of temperatures can use it in Are there conditions should avoid while using my system Connecting Your Controller to the VADPAK or HeartAttendant How do set up the HeartAssist 59 VAD Are there any special requirements Heart
13. Pull on Strain Relief Figure 5 9 Description of Components Disconnect the Percutaneous Cable from the old Controller see Figure 5 9 and immediately connect it to the replacement Controller Note The old Controller has an internal 9 volt battery that will cause the Controller alarm 10 11 to sound Ignore this alarm at this time or you may muffle the sound from the old Controller using a towel Press the Alarm Silence Button on the replacement Controller several times to silence alarms If alarm silences the pump is running Verify the connector is pressed in completely While holding the barrel of the connector pull the Strain Relief Nut on the connector to engage the locking mechanism Disconnect the connector for VADPAK Battery Pocket 2 from the Controller currently in the VADPAK Connect this cable into the bottom connector of the new replacement Controller Leave Battery properly seated in pocket Remove the old Controller from its slot in the VADPAK Remove the 9 volt battery from the old Controller and install it in the replacement Controller Press the Alarm Silence Button twice to silence the alarm see Figure 5 10 MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 25 Internal 9 volt Battery Screws Removed from Rear Cover of Controller Rear Cover Figure 5 10 Internal Battery 12 Insert the new replacement Controller into the Controller slot in the VADP
14. VAD System While at Home scsscscssessessesesseseseseeeees 61 Ro Ario 61 A VADPAK i pP ti di 61 11 43 Medications SU 61 12 0 Equipment Care and Maintenance eeeeeeeeeeeeeeee eene eennne nennen nnns 63 UE monis A CE UM 63 12 2 HearnAttendan asian daa ad Bancs d oS i dici end 63 124 Warranty and S CE VIC Se o coectetuer Matiz ducent den dde o a ee 63 12 41 O A a feda zu 63 12 5 Voltage Selector and Settings eene 64 13 0 Emergency Response and Troubleshooting eese 65 13 1 Emergency Response urinario dica 65 Tace OU ESO INIA cuidada 66 13 2 1 Non Pump Related Problems ted 66 T39 2 2 VADPAK PIODIGOIS eror t ig ore e deptos ia 69 13 23 HeartAttendant Problems a e eqs 70 14 0 The Pediatric Patient onHeartAssist 5 Pediatric VAD Support ee 71 14 1 oe Ins ia 71 jo rcd PAM Tr 71 14 3 Environmental Conditions reti ete noce ip eese ren Ere e pde ERE di 71 12 3 1 Temperatur cocto e UE pte rte o pes CORRI e lect ie brittle duis 71 14 3 2 Contact with LiQUIOS isc 72 14 3 3 Electromagnetic Interference ccccccesessecceeceeeessseeeeeeneeeeeeeeeedeceeeeeeeeneseeeeneeeee 72 14 3 4 Electrostatic DISCO xa cic tetto en mento pcdes x se dedi duck RAPERE ME 73 14 4 Operating the HeartAssist 59 Pediatric VAD System 73 14 5 Daily Oporto aide um R tae
15. disconnected ACTION TO BE TAKEN Verify the battery is firmly seated in the VADPAK battery pocket Verify the VADPAK battery pocket connector is firmly inserted into Battery 2 Port on the Controller Press the Alarm Silence Button of the Controller BATTERY 1 EXPIRED Figure 7 19 Diagnostic Alarm 8 BATTERY 2 DISCONNECTED Figure 7 20 Diagnostic Alarm 9 This alarm will clear automatically when a Battery is connected Diagnostic Alarm 10 The Battery plugged in VADPAK battery port 2 is discharged ACTION TO BE TAKEN Replace Battery 2 with a charged Battery This alarm will clear automatically when the discharged Battery is replaced with a charged Battery Diagnostic Alarm 11 The Battery plugged in VADPAK battery pocket 2 has discharged below 15 or it s voltage is too low ACTION TO BE TAKEN Replace Battery 2 with a charged Battery This alarm will clear automatically when the discharged Battery is replaced with a charged Battery MicroMed Cardiovascular Inc BATTERY 2 DISCHARGED Figure 7 21 Diagnostic Alarm 10 BATTERY 2 EXPIRED Figure 7 22 Diagnostic Alarm 11 The HeartAssist 5 VAD System Patient User s Manual 45 Diagnostic Alarm 12 The Controller failed the memory test at power up CONTROLLER ACTION TO BE TAKEN FAILURE Disconnect all power and power up a second time f alarm occurs at second power up Replace j a j Controller with bac
16. emergency MicroMed Cardiovascular Inc 58 The HeartAssist 5 VAD System Patient User s Manual It is recommended that when you travel away from home you 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 emergency Before going on extended trips notify your Support Team personnel 10 6 Bathing Caution Do not bathe or shower with the HeartAssist 5 VAD Pump connected to the HeartAttendant i e while in tethered mode Operating in untethered mode reduces the risk of shock Caution Do not shower with the VADPAK without it being properly encased in the provided Shower Bag Your doctor will provide instructions for the exit site care before during and after bathing or showering 10 7 Using the VADPAK and Shower Bag Step 1 Open the top cover of the Shower Bag Step 2 Insert the complete VADPAK unit including shoulder strap into the Shower Bag with the VAD Percutaneous Cable pointing towards the left as viewed facing the Shower Bag Figure 10 1 Using the VADPAK and Shower Bag Step 2 Step 3 Secure the VAD Percutaneous Cable to the side of the Shower Bag using the hook and loop strap attached to the left side of the Shower Bag MicroMed Cardiovascular Inc The HeartAssist 59 VAD System Patient User s Manual 59 Figure 10 2
17. handled carefully Precautions should be put in place to minimize the child s ability to play with cables and connections The child should be taught to recognize alarms and to immediately go to the parent or caregiver when an alarm occurs If the child is too young to detect audible alarms reliably it is recommended that the child always be within hearing distance of the parent or caregiver If the child is old enough to participate in his or her care and understand what to do the child should be encouraged to be responsible for changing of Batteries Since the duration of the Batteries will vary according to the pump speed you will only be able to estimate the time interval between battery changes If your child cannot change his or her Batteries you will need to develop a system whereby you or a caregiver is with the child around the time a battery needs changing If you cannot reasonably estimate the battery duration for your child it is advisable to keep the child within hearing distance so you will be able to detect the battery discharged alarm A rule must be made with your child that he or she will always have two Batteries in the VADPAK The VADPAK may be large for your child Adjust the shoulder strap and waist belt so the VADPAK fits securely on your child If the weight of the VADPAK pulls on your child s shoulder additional padding may be placed beneath the shoulder strap to reduce the force Your child should be taught to keep the
18. humidity is non condensing 30 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 attempt to wipe the liquid from the inside of the battery ports as the connector pins may become bent or otherwise damaged MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual xii Cautions 1 Federal law restricts this device to sale or use by or on the order of a physician or properly licensed practitioner 2 Implantable parts of this system should not be reused 3 Do not drop the HeartAttendant or the Controller on any hard surface Dropping it may damage internal components causing the device to malfunction 4 Do not submerge the Controller in liquid Submerging the Controller in liquid may damage internal components causing the device to malfunction Do not expose the Controller to moisture 5 Do not submerge Batteries in liquid or expose to heat Submerging the Batteries in liquid or expo sure to heat may cause them to malfunction Do not expose the Batteries to moisture 6 Do not expose the HeartAttendant to moisture 7 The operator should not attempt to make any changes to system software or use the device as a lap top computer Any modification of or attempt to modify the operating system software could result in rendering this device nonfunctional for its intended use 8 The HeartAttendant should not be used
19. is a completely external module It has audible and visual alarms with messages and prompts displayed on the Liquid Crystal Display LCD The Controller displays flow rate power consumption percentage battery charge remaining voltage Pump speed and various diagnostic and emergency messages MicroMed Cardiovascular Inc 2 3 The HeartAssist 5 VAD System Patient User s Manual The HeartAttendant Console The HeartAttendant is a portable console that is designed to power the HeartAssist 59 VAD while the patient is in the hospital and at home The HeartAttendant console provides power and communication for the HeartAssist 59 VAD charging and reconditioning batteries and transmitting data from the patient worn Controller The HeartAttendant software allows real time visualization of the pump performance and its interaction with the native heart via a flow wave form Also displayed are bar charts indicating battery charge levels power usage and mean flow Other screens allow your doctor or support personnel to program pump operating parameters and alarm levels Each patient is issued a HeartAttendant upon implant and keeps the device for the duration of the implant MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 3 0 Description of HeartAssist 5 VAD System 3 1 The HeartAssist 5 VAD System Pump Outflow Graft Flow Probe Inflow Cannula Curved inlet cannula depicted Percutaneous
20. near water while bathing or while showering due to the risk of electrical shock 9 The Controller must always be placed in the Surgery Pouch with battery or the VADPAK to promote proper cooling of the Controller and eliminate potential harm to the patient 10 The Percutaneous Cable from the patient to the Controller should be handled with care to prevent damage 11 All connectors should be handled with care and kept free of liquid dust or debris 12 Take care not to trip over the power cord Persons in the area should be instructed to take care to prevent tripping 13 The HeartAttendant may be cleaned by wiping down with a damp cloth followed by a wipe down with isopropanol to remove contaminants 14 Do not obstruct the fans on the back of the HeartAttendant Keep this area clear so that air can cir culate Keep this area clear so that air can circulate Overheating of the HeartAttendant could cause the Batteries to take longer to charge 15 Do not invert the cabinet of the HeartAttendant while installing Batteries MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual xiii 16 18 19 20 21 22 23 24 Avoid placing or operating the HeartAttendant in areas or near appliances that may expose it to temperatures outside its operating range of 10 C 50 F to 40 C 104 F Batteries not in use with the VADPAK should be recharging in the HeartAttendant or other
21. padded shoulder and waist support straps MicroMed Cardiovascular Inc 10 The HeartAssist 5 VAD System Patient User s Manual External Interface Port Figure 3 6 The VADPAK System with Controller and Batteries Installed 3 6 Independent Power Suppl The independent Power Supply see Figure 3 7 is a portable power supply designed to suppl power to the HeartAssist 5 VAD via the Controller It is an alternate power supply to the HeartAttendant This power supply is designed to be used with the VADPAK containing two charged batteries Figure 3 7 The Independent Power Supply MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 11 3 7 VADPAK Shower Bag The VADPAK Shower Bag see Figure 3 8 is designed to allow the patient to perform normal hygienic tasks such as showering while protecting the VADPAK Controller and Batteries from moisture O a od Eon RO AI E 42 Figure 3 8 The VADPAK Shower Bag MicroMed Cardiovascular Inc 12 The HeartAssist 5 VAD System Patient User s Manual MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 13 4 0 Environmental Conditions The HeartAssist 59 VAD System is made of tough durable materials but it does require some basic care as described below In addition Support Team personnel should perform periodic safety and function checks of your HeartAssist 59 VAD System equip
22. put in backwards and reinsert If the Battery Status Indicators still do not display this Battery may not be functional A Battery is charged when the Indicator icons are full Note Always check Batteries by pushing the charge level button on the Battery to verify charge level when removing from the HeartAttendant See Figure 5 1 on page 16 MicroMed Cardiovascular Inc 30 The HeartAssist 5 VAD System Patient User s Manual 6 4 Description of Screens The HeartAttendant uses six screens to display and configure the systems The patient has access to only two of these screens 6 4 1 Displays Common to All HeartAttendant Screens Each of the six screens shares a common Alarm Status bar across the top that indicates if an alarm has been detected and allows you to navigate to the Alarm History screen or Silence an alarm on the Controller Each of the six screens also shares a common bar across the bottom the Status Display and the Display Select Buttons sections NO ALARMS SLEEP ALARM HISTORY Ed Figure 6 6 Alarm Status Bar 77 PATIENT ID TEST1 BATTERY 1211112009 5 08 PM Figure 6 7 Status Display Status Display Shows the real time values for speed flow and power as well as the patient s ID number the date and time Figure 6 7 Speed The displayed VAD speed may vary due to pulsatility Flow Average flow through the VAD is in liters per minute Instantaneous flow is shown graphically i
23. specified type as listed on the rear panel of the HeartAttendant are used for replacement The use of makeshift fuses or short circuiting of the fuse holder is prohibited Caution Any interruption of the protective conductor inside or outside the HeartAttendant while the mains are connected is likely to make the device dangerous Intentional interruption of the protective conductor is prohibited while the mains are connected MicroMed Cardiovascular Inc The HeartAssist 50 VAD System Patient User s Manual 37 Section 7 7 0 The Controller Front Panel Display Alarms and Troubleshooting LCD Display Battery 1 LED Indicator Battery 2 LED Indicator Alarm Silence Fail Safe Mode Scroll Display Backlight Button Indicator Button Figure 7 1 Controller Front Panel The battery indicators on either side of the front display of the Controller indicate four different conditions for each Battery Battery Indicator Condition Green Controller is using this Battery to run the Pump Blinking Amber Battery is discharged disconnected or expired Off Battery is connected charged but not currently being used to run the Pump Solid Green 3 seconds Occurs immediately following a Battery insertion into a VADPAK Battery Pocket or when a Battery Pocket Cable plug with a charged battery is inserted into a battery port MicroMed Cardiovascular Inc 38 The HeartAssist 5 VAD System Patient User s Manual
24. which points toward the appropriate Battery slot VADPAK Battery Pocket 2 is the pocket that is closest to your body when carrying the VADPAK It is also designated by the number MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 19 2 triangle located on the top of the VADPAK plastic housing which points toward the appropriate Battery slot The battery indicator for that Battery on the Controller front panel will be blinking amber and the indicator for the other Battery will be green if that battery is above 25 otherwise it will be solid green and blinking amber simultaneously 8 Align the long groove in the Battery with the pocket and insert the charged Battery into the pocket until a slight click is felt At this time three beeps will be heard from the Controller and the LED indicator for this new Battery will light green for three seconds 9 Press the Alarm Silence Button on the Controller The LED for the new Battery Turns from_amber to green if the replaced Battery is a lower charge than the other connected Battery or Turns from_amber to off if the replaced Battery is a higher charge than the other connected Battery 10 Close the VADPAK battery pocket cover ensuring the pocket is well sealed see Figure 5 7 Verify the percent charge of the replaced Battery on the Controller LCD display WARNING Only remove one Battery at a time from the VADPAK Never remove both Batteries simultaneo
25. without proper alignment Do not twist the connector plug while inserting after the connectors are aligned f all connections are tight and all components are working properly the Controller front panel will display DAS CONNECTED if using the HeartAttendant cable while in the hospital Contact the Support Team for a VADPAK replacement MicroMed Cardiovascular Inc 70 The HeartAssist 5 VAD System Patient User s Manual 13 2 3 HeartAttendant Problems Situation Reason Action Battery Status Light fails to Installation of inappropriate Battery Battery Reseat battery light when Battery is inappropriately seated dirty Battery connector inserted Call the Support Team System Status Light blinks AC power out or blown side fuse of the Check power fuses red HeartAttendant Call the Support Team System Status Light does not light when cord is plugged into main outlet No AC power is supplied to HeartAttendant9 blown power fuse microprocessor has not passed self test Check power fuses Call the Support Team Batteries take a long time to charge or do not charge Exposure to too low or too high a temperature faulty Battery or faulty HeartAttendant charger Call the Support Team Replacement fuse blows Installation of incorrect fuse Check fuses and replace with correct ones Call the Support Team Reduced fan sound warm HeartAttendant extend
26. ADPAK should be charging in the HeartAttendant at all times see Figure 6 3 Approximate charge time for a fully depleted Battery is two hours 1 Inspect the connector end of each Battery to ensure that it is clean 2 Insert one or more Batteries connector side up in the battery compartments on the front of the HeartAttendant Figure 6 3 making certain each Battery is fully seated by the display of charge level on the Battery Charging screen on the HeartAttendant Figure 6 4 MicroMed Cardiovascular Inc The HeartAssist 59 VAD System Patient User s Manual 29 585 m Figure 6 3 Batteries Seated in HeartAttendant Battery Slots 3 When you insert the Batteries into the HeartAttendant the Battery Status Indicator icons should display immediately There are four icons at the bottom of the Patient Display screen Figure 6 4 and four larger icons on the Battery screen Figure 6 5 Batteries begin recharging as soon as they are inserted into the HeartAttendant If the Battery Status Indicators do not light up the Battery has not been recognized NO ALARMS SLEEP ALARM HISTORY L SLEEP ALARM HISTORY EJ BATTERY BATTERY BATTERY BATTERY 1 2 3 4 108 D wwe 108 so LO m LI LI LI se E E sol mi se so m se o 1 mm 2 mm 3 mum 4 mmi Figure 6 4 Battery Display Screen Figure 6 5 Patient Display Screen 4 Check to make sure that it has not been
27. AK 13 Screw the White Defibrillation Insulator onto the RAEC with finger tight pressure only see Figure 5 11 White Defibrillation Insulator screwed onto RAEC Percutaneous Cable Connector This protects the connector and the locking mechanism Figure 5 11 Attaching the White Defibrillation Insulator 14 Close and secure bag cover MicroMed Cardiovascular Inc 26 The HeartAssist 5 VAD System Patient User s Manual 15 Contact your Support Team to ensure that the Pump speed and alarm settings do not need to be adjusted Note In the unlikely event that the VADPAK is damaged the HeartAttendant or a single Battery Pocket with a fully charged Battery should be connected to a battery port on the Controller MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 27 6 0 HeartAttendant The HeartAttendant is a portable console that is designed to power the HeartAssist 59 VAD while the patient is in the hospital and at home The HeartAttendant console provides power and communication for the HeartAssist 5 VAD charging batteries and transmitting data to the patient worn Controller The HeartAttendant software allows real time visualization of the pump performance and its interaction with the native heart via a flow wave form Also displayed are bar charts indicating battery charge levels power usage and mean flow Other screens allow your doctor or support personnel to program pump
28. Assist 5 VAD System Patient User s Manual Caution The system has not been tested with each possible brand of device and the possibility of electromagnetic interference may exist If you experience unexpected changes in the speed of the HeartAssist 59 VAD see if there is a potential source of electromagnetic interference such as cellular phones radio transmitters or microwave ovens within a few feet If there is move away from the potential source and see if the HeartAssist 59 VAD operation returns to normal If it does not return to normal contact your Support Team Warning Do not undergo an MRI The strong magnetic field may affect device operation causing injury to you Warning Do not use the HeartAttendant with ventricular assist devices other than the HeartAssist 5 VAD System Relative Humidity Do not operate the HeartAttendant where relative humidity is non condensing 30 75 Rh MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 15 5 0 Connecting Your Controller to the VADPAK or HeartAttendant You should practice connecting the HeartAssist 59 VAD System to the VADPAK or HeartAttendant with your Support Team personnel before connecting it on your own This lets you become familiar with each part of your system how they connect and what they do If you have any questions during the system connection please contact your Support Team personnel for more informat
29. Attendant MicroMed Cardiovascular Inc Section 7 Section 8 Section 9 Section 10 Section 11 Section 12 Section 13 Section 14 The HeartAssist 5 VAD System Patient User s Manual How do connect to recharge and use the HeartAttendant The Controller Front Panel Display Alarms and Troubleshooting What do the different messages on the display mean What do the alarms mean What do do if there is an alarm Summary of Use What should do if something happens Daily Checks How do check to see if the HeartAssist 5 VAD is working properly What do need to do every day Daily Operation What will be able to do while using this device How often will need to change Batteries and how will tell Are there some things should not do while using the HeartAssist 59 VAD Self Care How do take care of the area where the Pump Percutaneous Cable comes out of my body i e exit site When will need to see my doctor Equipment Care and Maintenance How do take care of the HeartAssist 5 VAD and its components Do need to clean them Is there someone can speak with if need advice Emergency Response and Troubleshooting How do troubleshoot my system The Pediatric Patient onHeartAssist 5 Pediatric VAD Support Are there special considerations for children using the HeartAssist 5 Pediatric VAD MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s
30. BE TAKEN Contact the Support Team immediately Patient must return to the hospital for one or more Excess Current Alarms which cannot be cleared in 10 minutes or for multiple Excess Current Alarms over a period of more than 10 minutes but less than 24 hours Diagnostic Alarm 2 The flow rate measured by the implanted flow probe of the REDUCED VAD Pump has dropped below the programmed alarm value FLOW RATE Note This alarm does not silence or clear automatically The Controller Alarm Silence Button must be pressed to silence and clear this alarm Figure 7 13 Diagnostic Alarm 2 ACTION TO BE TAKEN Contact the Support Team immediately Diagnostic Alarm 3 The speed RPM of the VAD Pump has fallen below the REDUCED programmed alarm value MOTOR SPEED ACTION TO BE TAKEN Contact the Support Team immediately Figure 7 14 Diagnostic Alarm 3 MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 43 Diagnostic Alarm 4 The internal battery of the Controller is low on power LOW ACTION TO BE TAKEN INTERNAL BATTERY e For changing this battery contact the Support Team immediately Figure 7 15 Diagnostic Alarm 4 Diagnostic Alarm 5 The VAD Pump has stopped and is attempting to restart PUMP This text displays briefly during restart attempt alternating with the PUMPED STOPPED message RESTARTING ACTION TO BE TAKEN e Every 2 to 3 seconds press the Alarm Si
31. BLE connect to the HeartAttendant 2 Remove one Battery at a time from the VADPAK and replace with a charged Battery until both Batteries are replaced DO NOT REMOVE BOTH BATTERIES AT THE SAME TIME 3 Place the toggling Batteries aside to return to the Support Team 4 Contact the Support Team for replacement batteries Who Do Call Support Team PUMP RESTARTED The Controller has attempted to restart the VAD Pump This alarm is displayed every time the Controller tries to restart the Pump 1 Contact the Support Team imme diately 2 If no current is shown on the Controller and the Pump has stopped change to the backup Controller 3 If this does not start the Pump current flow registered seek emergency help immediately Support Team MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 49 Alarm What Happened What Do I Do Who Do Call PUMP The VAD Pump has 1 First check for other alarms Support STOPPED stopped flashing which may show why the Team Pump has stopped For example VAD DISCONNECTED or BOTH BATTERIES DISCONNECTED 2 Be sure that the Percutaneous Cable has not been cut or dam aged 3 See if an unknown electrical dis turbance is affecting the Control ler or Pump Do this by physically moving to a different location if possible If the Pump successfully restarts press the Alarm Silence Button on the Controller I
32. HeartAssist 5 Straight VAD Pump 3 3 The Controller The Controller has two battery ports and one VAD port The front display of the Controller contains the Liquid Crystal Display LCD two battery Light Emitting Diodes LEDs one fail safe LED and two buttons one to silence alarms and the other to scroll the display information The Controller is designed to be reliable and easy to operate You can view the operational parameters of your VAD on the LCD as well as any emergency or diagnostic alarms that may occur See Section 6 0 HeartAttendant for a description of front panel display and alarms MicroMed Cardiovascular Inc 8 The HeartAssist 5 VAD System Patient User s Manual LCD Liquid Crystal Display VAD Connector Battery 2 Port Black Ring Battery 1 Port Black Ring Battery 1 Status Battery 2 Status Indicator Indicator Alarm Silence Fail Safe Mode Scroll Display Button Active Indicator Button Figure 3 4 The Controller 3 4 The HeartAttendant Console The HeartAttendant is shown in Figure 3 5 The HeartAttendant combines the functions ofthe CDAS and the PHSS units It is designed to power the HeartAssist 5 VAD and Controller and at the same time charge and recondition four batteries The HeartAttendant has a 7 5 touch screen for patient viewing of the Patient and Battery Status screens and for physician or support staff viewing of the Patient Battery Holter Pump Setup and Data status screens using a pa
33. TIS D elt tnn cons 5 S NM Idiot M 6 3 3 The Controlado 7 3 4 The HeartAttendant Console tette tentent tents 8 3 5 VADPA TP 9 3 6 Independent Power Supply tede e e E rid c Ete its 10 J P MADPAK Shower Bag eret ate iia 11 4 0 Environmental Conditions eeeeeee cesse eene eene neun nean nnn nnn an anna n amu a nnn 13 4 1 Temperature Gondiorns nd da 13 4 2 Contact with Liquids s eot dica Deus cd ues D MEE 13 4 3 Electromagnetic Interference ici io 13 A ea ba e exei x depu s hue i reda LAGO TEAR REA ded 14 5 0 Connecting Your Controller to the VADPAK or HeartAttendant 15 5 1 General CoDsiBerallOlnis ctocuocc eso Sep rcr eo SAU i Dena Rua yis ade 15 5 2 HeartAttendant Console nter tremere rt i d tk tk nns 16 A ISPs remo eub A ed ctus es o eor ANO 16 54 Batteries ET 16 5 4 1 Connecting a Battery Cable to the Battery POlt ooonioooccccncccononoconnccnononocnonannnnnos 16 5 4 2 Battery Indicators on the Controller airada 18 5 4 3 Changing a Battery in the VADPAK ococcccnnnccccccnnncccccnononcnnonnncnnnnnnnnncnnnnnnccccnnns 18 5 5 MADPAIS I ON Send tes adsolet tees Lua uoces c io AN 20 5 51 o Manage the VADPAK s i tette dl 20 5 6 Controller Replacemierit 0 oot te e ete ee 23 5 0 HeanA tendant 2ccesic metn tuia OE ede EET 27 6 1 Connecting to the Power SODEOD 5 ias 27 6 2 Using the HeartAttendant as a Power Source s
34. The HeartAssist 5 VAD System Patient User s Manual Miniaturized ventricular assists technology co developed with Dr Michael E DeBakey Dr George P Noon and the National Aeronautics and Space Administration NASA MicroMed Cardiovascular Inc 8965 Interchange Drive Houston TX 77054 CAUTION Federal USA law limits the sale and use of the HeartAssist 59 VAD to investigational use only The HeartAssist 59 Pediatric VAD is authorized by Federal law for use in providing temporary left side mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients 5 16 years old with BSA greater than or equal to 0 7 m and less than 1 5 m who are in NYHA Class IV end stage heart failure are refractory to medical therapy and who are listed candidates for cardiac transplantation The effectiveness of this device for this use has not been demonstrated L00224 Rev ii The HeartAssist 5 VAD System Patient User s Manual Warning Read this entire manual before handling the HeartAssist 59 VAD without supervision Quick Reference Support Team Phone Numbers Title Name Phone Number Emergency Assistance Cardiologist Cardiothoracic Surgeon Nurse Technical Assistance 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 and or medical staff traine
35. Using the VADPAK and Shower Bag Step 3 Step 4 Close the lid of the Shower Bag and carefully press the sides of the cover inward to secure the hook and loop fasteners located along each face of the Shower Bag Figure 10 3 Using the VADPAK and Shower Bag Step 4 Step 5 When finished bathing carefully dry off the outside of the Shower Bag open the top cover of the Shower Bag and remove the VADPAK If water has leaked into the Shower Bag contact the hospital staff immediately Note Limit the time 30 minutes the VADPAK and Controller are used in the Shower Bag since the Controller requires air circulation for proper cooling MicroMed Cardiovascular Inc 60 10 8 10 9 The HeartAssist 5 VAD System Patient User s Manual Activity Restrictions The HeartAssist 59 VAD System lets you move around and be active however there are some restrictions associated with the device You should discuss with your doctor what activities you may do The following activities are always prohibited for your safety and for the function of the device Absolutely NO Total Body Submersion i e swimming Comments Do not submerge the Controller or Batteries in water Submerging them may cause the device to malfunction Steam Bath or Dry Saunas Do not operate the system in environments where the temperature is less than 10 C or greater than 40 C Participation in Contact Sports Hard physical contact with other peop
36. VADPAK Battery M00098 or M00527 Note Use MicroMed Cardiovascular Inc replacement parts ONLY For a mains power cord replacement please contact MicroMed Cardiovascular Inc 12 5 Voltage Selector and Settings Voltage and Setting North American 120V MAINS AC European 240V MAINS AC MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 65 13 0 Emergency Response and Troubleshooting An emergency situation may be caused by conditions requiring medical care or by a mechanical problem that interferes with the pumping ability of the HeartAssist 59 VAD It is important to learn how to identity and respond to an emergency The most important action is to restore power and function to the HeartAssist 59 VAD 13 1 Emergency Response 911 or local emergency number should be called when any of the following symptoms occur Loss of Consciousness e Seizures or Convulsions e Inability to Move or Speak e Sudden Collapse e Conditions for Calling the Doctor as provided by your physician Warning BEFORE EXTERNAL DEFIBRILLATION the patient should be receiving power from the two VADPAK Batteries in the VADPAK If AC power is lost ensure that fully charged batteries are installed in the VADPAK remove the Controller connector from the HeartAttendant and travel to the nearest source of correct AC power with the HeartAttendant MicroMed Cardiovascular Inc 66 13 2 Troublesho
37. VADPAK closed at all times except for when changing a battery or checking the Controller Active children should be cautioned against upside down maneuvers on jungle gyms or other apparatus because the Batteries or Controller may come loose from the VADPAK if the Velcro flaps are dislodged Your child will almost certainly get the VADPAK dirty You may wipe the exterior of the bag with a slightly damp cloth to clean taking care not to get water inside the VADPAK If the child would like you may 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 it may be desirable to keep your child from sitting and playing in sand or dirt Your child s VADPAK should be exposed to ambient air to allow proper cooling and to prevent the alarms from being muffled You should not allow your child to wear the VADPAK beneath clothing for extended periods of time MicroMed Cardiovascular Inc 74 14 5 The HeartAssist 5 VAD System Patient User s Manual The percutaneous cable connection to the VADPAK or Controller should be protected because it links the pump inside your child s chest to the equipment that runs that pump on the outside of your child s body Even though the HeartAssist 59 Pediatric VAD is designed to prevent the cable from catching on objects and being pulled you sh
38. ace E M Cute 74 14 5 1 LEAVING your lose ote rr pon eet a 74 14 5 2 Return to SO cc seed cs too d disent se prc iius 74 145 3 AGUVITIOS eee etre Ec rs d Cle bed end Dia SS apt lee ira 74 A att ade wad niece te cee ttle a peated EEA aa AE A eee aN 75 14 5 5 itj M AE ee 75 14 6 Emergencies oet rtr reed oa cte erdt iactat mida rd cedet as acea da EEEE aei 75 MicroMed Cardiovascular Inc vi The HeartAssist 5 VAD System Patient User s Manual MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual vii Figures 3 0 Description of HeartAssist 59 VAD System Figure 3 1 The HeartAssist 5 VAD System 0 0c cc cece cece eee ence ene eas 5 Figure 3 2 Assembled HeartAssist 5 VAD Pump 0 00c0c e 6 Figure 3 3 Assembled HeartAssist 5 Straight VAD Pump 000ceec eee eeeeuee 7 Figure 3 4 The Controller ii sss erp REDE Oe oes digas ee aw awe oA e eek ee ee 8 Figure 3 5 The HeartAttendant Console 2 0 0 0 0c ccc cee cent eee 9 Figure 3 6 The VADPAK System with Controller and Batteries Installed 10 Figure 3 7 The Independent Power Supply 000 eee 10 Figure 3 8 The VADPAK Shower Bag 0c eee n 11 5 0 Connecting Your Controller to the VADPAK or HeartAttendant Figure 5 1 Battery Charge Indicators cicle A A ad 16 Figure 5 2 Connecting the VADPAK Battery Pocket Cable
39. ce Port Check the battery status for both VADPAK Batteries e Press the Scroll Display Button until you see the default screen 1 with the battery percent values Determine which Battery the VAD Pump is receiving power from by looking at the battery LED indicator of the Controller The Battery with a green indicator is providing power to the VAD Pump Disconnect the connector of the backup Battery Battery not in use in the VADPAK The Battery with no indicator light lit is the Battery not being used Firmly hold the connector with one hand e With the other hand firmly hold the Controller e Pull the connector from the Controller This connection may be tight and may take some force to pull it loose e Press the Alarm Silence Button on the Controller front panel Note If you do not press the Alarm Silence Button on the Controller front panel the alarm will sound and tell you it is disconnected Connect the HeartAttendant Controller Interface Cable to the Controller Visually align the slot on the cable connector with the red dot on the Controller port e Once the slot and red dot are aligned firmly push the plug straight into the Controller port A slight click will be heard and felt as the connector becomes fully seated HeartAttendant is connected to the External Interface Port of the VADPAK but is not indicated on the Controller display Caution Damage can occur if the connector is forced
40. d in the operation of the HeartAssist 59 VAD System The name and phone number of this per son your medical doctor and heart surgeon are listed above It is recommended that patients who have a limited ability to care for themselves or communicate clearly should have a trained companion available Conditions for calling for Emergency Assistance Call your local emergency number when any of the following symptoms occur e Loss of Consciousness e Seizures or Convulsions e Inability to Move or Speak Sudden Collapse 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 Anytime you re feeling bad MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual iii Contents Emergency IMPOrmation c aldea ii PIQUE OS anna a Vii General Warnings and Precautions cccsssseeeeeeeseeeeneeeeeeeeesseeeeeeeeeeenseeneeeeeeeeeeseeeeeeeeees xi 1 0 KOM ais D 1 2 0 Introduction to the HeartAssist 59 VAD unicornio 3 2 4 The PUMP System eoe oS redet did 3 22 The CORTO neral lia lit elos 3 23 The HeartAttendant Console tala 4 3 0 Description of HeartAssist 59 VAD System ccoo 5 3 1 The HeartAssist 5 VAD SUSIBI
41. d respond to an emergency The most important action is to restore power and function to your child s HeartAssist 59 Pediatric VAD Local emergency services should be briefed about your child s heart pump and you should have a ET AS with your m to aeiae these emergency de when needed Hyeur SS Cardiopulmonary resuscitation CPR may be performed for children with a HeartAssist y Pediatric VAD You may not be able to feel the child s pulse even if the pump is operating normally so CPR and defibrillation should not be done if your child is awake and responsive even if a pulse cannot be felt If you lose power to your home and you are not certain when it will be restored you should move your child and his or her PHSS er HeartAttendant with Batteries to a location that has power as soon as possible to prevent pump stoppage due to battery expiration Prevention is the key to handling emergencies with the child who has a HeartAssist 59 Pediatric VAD especially if that child is old enough to sometimes be without a parent or caregiver The child should always carry identification as an assist device patient with contact information for the parent and physician The child s teachers coaches classmates friends and siblings should be educated about theHeartAssist 59 Pediatric VAD and taught what to do in the case of emergency for your child If your child is not with you he or she should be accompanied by a responsible MicroMed Cardiovascular I
42. dow NO ALARMS SLEEP ALARM HISTORY ul Figure 6 9 Alarm Status Bar with Sleep and Alarm History Buttons SLEEP ALARM HISTORY a Figure 6 10 Alarm Status Bar with Sleep and Alarm History Buttons and Alarms Detected MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual SLEEP ET HISTORY j i Figure 6 11 Alarm Status Bar with Sleep and Alarm History Buttons and Emergency Alarms Detected Alarm Status Bar The bar across the top of the all screens This bar is green when conditions are normal Figure 6 9 it will flash yellow when a diagnostic alarm occurs Figure 6 10 and it will flash red when an emergency alarm occurs Figure 6 11 Alarm History Button Opens a pop up window that allows review of alarm messages that are stored on the HeartAttendant for the patient CURRENT ALARMS ALARM HISTORY Reduced Flow Rate 11Jun09 12 18 39 PP a 5 Rmo r z tiJunO9 12 18 35 taducad Motor Spaec Reduced Motor Sp 11Jun09 12 18 39 iem Ineusdfim Dil 11Jun09 12 18 34 Reduced Motor Speed Time Unknown Battery 1 Disconnected Time Unknown Battery 1 Disconnected fiJun09 11 49 20 Reduced Motor Spoed 11Jun09 11 43 13 Reduced Motor Speed Time Unknown Bath Batterias Disconnected Time Unknown Reduced Flow Rate Time Unknown Low Internal Battery Time Unknown Battery 1 Disconnected Time Unknown Battery 2 Discharged Time Unknown Battery 2 Expired Figure 6 12 Current Alarms and Alarm Hist
43. e inserted only into a socket outlet provided with a protective earth contact 6 5 1 1 Mains Voltage Cord Mains Voltage Range and Fuses Before plugging the HeartAttendant into an electrical outlet make sure that the HeartAttendant is configured for local mains voltage The following are warnings typical to medical electrical equipment which also apply to the HeartAttendant These warnings appear on HeartAttendant labeling 1 The HeartAttendant should be disconnected from all voltage sources when a fuse is to be replaced 2 The nominal mains voltage and frequency is 120VAC 60Hz or 240VAC 50Hz 3 Afuse holder is located on the rear panel of the HeartAttendant in the mains input socket When the mains fuse needs replacing proceed as follows Figure 6 16 1 Disconnect the HeartAttendant from the mains line 2 Remove the cover of the fuse holder using a small screwdriver Figure 6 16 Mains Input Socket on the Rear Panel of the HeartA ttendant MicroMed Cardiovascular Inc 36 The HeartAssist 5 VAD System Patient User s Manual 3 Fita new fuse of the correct rating according to the rear label of the DAS box Figure 6 17 and reinsert the fuse holder into the power entry module Figure 6 17 Fuse block in power inlet module 4 Power on the HeartAttendant and check functionality by watching for normal boot up Caution Make sure that only fuses with the required current rating and of the
44. e your child is in the presence of devices that may cause electromagnetic interference including toys that use wireless or radio controlled technology If an unexpected change occurs ask your child to move away from the potential source If the pump function does not immediately return to normal when the source is removed you should contact your Support Team MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 73 14 3 4 Electrostatic Discharge Testing has demonstrated that the function of the HeartAssist 5 Pediatric VAD is not affected by electrostatic discharge However children often come in close contact with television screens or computer monitors Although this should not effect the operation of the HeartAssist 59 Pediatric VAD you should consider teaching your children to stay a safe distance from television screens and other sources of electrostatic discharge as an added measure of safety 14 4 Operating the HeartAssist 5 Pediatric VAD System Sections 5 and 6 of this manual tell you how to operate and manage your child s HeartAssist 5 Pediatric VAD System A few additional comments should be made specific to device management for the pediatric patient As appropriate for his or her age you should help your child understand the device that is supporting his or her life in particular the child should understand that the Controller and other components of the system are not toys and should be
45. ed charging time for Batteries Slow fuse blown fans power Fan malfunction Main input voltage inappropriate Call the Support Team Check voltage selector on Power Entry Module Call the Support Team Blown fuse System Status Light not illuminated Use of incorrect or too long an extension cord power failure when unattached to Controller dirty or broken cable connector or broken cable failure of audible alarms with full discharge of Batteries Replace power fuses Call the Support Team Green LED on Controller does not indicate HeartAttendant is supplying power to Controller port 1 Blown fuse on rear of HeartAttendant Or improperly seated connectors on HeartAttendant Controller Interface Cable Verify connections to HeartAttendant and VADPAK are properly seated Call the Support Team MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 71 14 0 The Pediatric Patient onHeartAssist 59 Pediatric VAD Support All of the material previously presented in this Patient User s Manual is true for the pediatric patient It is expected that pediatric patients between 12 and 16 years of age will encounter situations similar to the adult patient as described in this manual This section provides guidance for situations that pediatric patients especially younger children might encounter and is aimed at the child s parents or caregiver Parents o
46. en resolved the audible alarm will stop When the VADPAK is then reconnected to the HeartAttendant the same alarm that was previously resolved will not appear as a flashing red bar but will show in the alarm list as the alarm description followed by Time Unknown Diagnostic Alarm Yellow Flashing Bar A yellow flashing bar signals a diagnostic alarm given by the Controller previously described in Section 7 2 2 Diagnostic Alarms on page 42 and shown in Figure 6 10 on page 31 VADPAK Connected to the HeartAttendant When the VADPAK is connected to the HeartAttendant and a diagnostic alarm occurs the audible alarm from the Controller may be silenced by pressing the silence button on the Controller Pressing the silence button on the Controller does not clear the flashing bar on the HeartAttendant The speaker icon must be pressed for the flashing yellow bar to return to the normal green display VADPAK Not Connected to the HeartAttendant When the VADPAK is not connected to the HeartAttendant and a diagnostic alarm occurs it can be silenced by pressing the silence button on the Controller When the VADPAK is then reconnected to the HeartAttendant the same alarm that was previously silenced will appear as a flashing yellow bar MicroMed Cardiovascular Inc 52 The HeartAssist 5 VAD System Patient User s Manual MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 53 9 1 9 0
47. ent User s Manual 55 10 0 Daily Operation Always connect the Controller to two power sources lt draws power from one source at a time The second source serves as backup power When you are using the two Batteries in the VADPAK as the two power sources check the remaining charge in each Battery every hour While you are relaxing or sleeping you should use the HeartAttendant in the tethered mode of operation Most of the time that you are active you will use the Batteries in the VADPAK in the untethered mode of operation You will not be connected to the HeartAttendant 10 1 10 2 Tethered Operation During times of little activity such as when you are sleeping or relaxing it is recommended that you use your HeartAttendant This is called the tethered mode of operation You must be in tethered mode whenever you think you might fall asleep or if you do not have charged batteries available for use in the VADPAK When you use the HeartAttendant the Controller uses power from the grounded wall outlet The Controller can also get power from the batteries in the VADPAK if the wall outlet fails Note A fully charged Battery will provide adequate power to run the Pump for 2 5 to 4 hours If your Pump speed is set high it will reduce the amount of time the Battery can operate the Pump To Switch from Untethered to Tethered Operation 10 2 1 Be Sure that the HeartAttendant is ready to be used The HeartAttenda
48. er and replace with the spare Battery Pocket connector Verify connection of the Battery using the Controller display Remove the Battery 1 connection to the Controller and replace with the HeartAttendant Controller Interface Cable Verify connection of the HeartAttendant using the Controller Display The Controller should no longer be connected to the VADPAK at this point Drain the liquid from the VADPAK and contact the Support Team immediately for assistance If spare Battery Pocket and the HeartAttendant are not available DO NOT disconnect the Controller Try to drain liquid and contact the Support Team immediately REMEMBER Always carry extra Batteries a spare Battery Pocket and a spare Controller with you MicroMed Cardiovascular Inc 68 The HeartAssist 5 VAD System Patient User s Manual Situation Action A battery or VADPAK is submerged in Liquid If the Battery is in the VADPAK battery pocket remove it immediately from the pocket DO NOT attempt to use or recharge this battery Contact the Support Team for a replacement Battery MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 13 2 2 VADPAK Problems Situation HeartAttendant is Connected to the External Interface Port of the VADPAK but is not indicated on the Controller display 69 Action Verify that the HeartAttendant Controller Interface Cable is correctly inserted in the External Interfa
49. f heat sources Note The VADPAK carry bag is flame retardant but care should be exercised when used near open flame or embers Any hot item that falls onto or within the bag should be removed as quickly as possible to prevent scorching or marring of the materials Special care should be taken if your child is around campfires or other sources of open flame You should teach your child to stay a safe distance away from them Contact with Liquids All forms of liquid should be kept away from the equipment in order to prevent accidental spills For example you may want your child to wear an apron or bib while eating so drinks don t spill on the VADPAK or its components The equipment should never be submerged in any liquid Young children may need to be watched carefully when near sources of water such as the bathroom as they may 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 Pediatric VAD Bathing while wearing the HeartAssist 59 Pediatric VAD is covered later in Section 14 5 Daily Operation Electromagnetic Interference Testing has shown that there is little risk from electromagnetic interference e g cellular phones microwave ovens etc with the HeartAssist 59 Pediatric VAD However not all brands of every type of device were tested It is important to observe your child s pump functions e g flow and speed closely anytim
50. f the Controller doesn t restart the Pump the alarm will continue even after the Alarm Silence Button is pressed If the Pump does not start call for emergency medical assistance immediately REDUCED FLOW Flow rate from the Contact the Support Team Support RATE Pump is reduced Team below the alarm value REDUCED MOTOR The VAD Pump speed If you don t have any symptoms Support SPEED is reduced below contact the Support Team If you Team alarm value experience dizziness light headedness or other symptoms seek medical assistance MicroMed Cardiovascular Inc 50 The HeartAssist 5 VAD System Patient User s Manual Alarm What Happened What Do I Do Who Do Call VAD The VAD Pump is 1 See that the VAD Percutaneous Support DISCONNECTED disconnected from the Cable is not cut or damaged Team Controller 2 Unscrew the White Defibrillation Insulator from the RAEC 3 Remove VAD Percutaneous Cable connector from the RAEC 4 Plug the VAD Percutaneous Cable back into the RAEC mak ing sure the plug is fully seated connected in the RAEC mating connector 5 Screw the White Defibrillation Insulator onto the RAEC connec tor If the problem persists replace the Controller with the backup Controller If the Pump does not start call for emergency medical assistance immediately FAIL SAFE LED Controller malfunction Replace Controller Support Team CONTINUOUS Controller malfunction Replace Co
51. fully seated Caution Damage can occur to the HeartAttendant or VADPAK cable Controller ports or VADPAK port if the connector is forced without proper alignment DO NOT try to force a Battery cable plug into the Battery port on the Controller Verify the correct VADPAK cable plug is being inserted into the correct battery port on Controller and the red dots are aligned When removing the cable hold the connector and pull out DO NOT twist the battery plug while inserting or removing after the connectors are aligned 5 The Controller will sound three audible beeps and display a 3 second solid green light for that VADPAK Battery Pocket to indicate a correct insertion Align the slot on the VADPAK Battery Pocket Cable with the red dot Figure 5 2 Connecting the VADPAK Battery Pocket Cable Note Both of the Controller s battery ports are identical and the Controller will automatically switch to take power from the appropriate Battery port MicroMed Cardiovascular Inc 18 5 4 2 5 4 3 The HeartAssist 5 VAD System Patient User s Manual Battery Indicators on the Controller The battery port indicators on either side of the front display indicate four different conditions for each battery Battery Indicator Condition Green Controller is using this Battery to run the Pump Blinking Amber Battery is discharged disconnected or expired Off Battery is connected charged but not currently being used to run t
52. ge level button on each Battery to verify charge level see Figure 5 1 on page 16 Remove only one discharged Battery from the VADPAK battery pocket and insert the fully charged Battery Remove the second discharged Battery from the VADPAK battery pocket and insert the fully charged Battery Note Never remove both Batteries from the VADPAK battery pocket at the same time e Check the capacity of the new Battery connected to the Controller on the Controller front panel 10 4 2 Disconnecting the VADPAK From the HeartAttendant Disconnect the HeartAttendant Interface Cable connector from the External Interface Port of the VADPAK as follows e With one hand firmly hold the VADPAK casing With the other hand pull the connector from the External Interface Port This connection may be tight and may take some force to pull it loose Note Do not twist the connector while removing Do not pull on the wire Note During the untethered operation check the battery capacity of both VADPAK Batteries every hour to be sure that enough power is available Note Always ensure that the HeartAttendant Controller Interface Cable has been disconnected from the VADPAK BEFORE removing power to or turning off the HeartAttendant 10 5 When Away From the Residence Always travel with fully charged batteries spare Controller spare battery pocket and carry extra Batteries as well as the HeartAttendant You may need these components in an
53. he Pump Solid Green 3 seconds Occurs immediately following a Battery insertion into a VADPAK Battery Pocket or when a spare Battery Pocket Cable plug with charged battery is inserted into a Battery port Note The Controller always uses the Battery with the lower charge down to 25 thus preserving the Battery with the highest charge Note You must periodically every 2 to 3 hours visually inspect the front panel of the Controller to verify Battery status in case the diagnostic audible alarm fails Changing a Battery in the VADPAK Verify the replacement Battery is fully charged by pressing the charge status indicator on the Battery see Figure 5 1 All four green LEDs on the Battery should illuminate indicating a charge between 75 to 100 Open the VADPAK Press the scroll display button on the front panel of the Controller to the screen displaying the battery status Check the remaining Battery charge level for each Battery Determine which Battery is to be changed by selecting the Battery with the lower charge ensuring the remaining Battery indicates adequate charge on the Controller LCD display Open the VADPAK battery pocket cover secure by hook and loop fastener see Figure 5 6 Slide the Battery from the pocket VADPAK Battery Pocket 1 is the pocket that resides furthest away from your body when carrying the VADPAK It is also designated by the number 1 triangle located on the top of the VADPAK plastic housing
54. ion 5 1 General Considerations This equipment has alarm sounds and light indicators to let you know about important system conditions The Controller has a display to tell you about these conditions 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 etc To avoid the possibility of electric shock replace frayed or damaged cords and plugs by contacting your Support Team personnel Use only the power cord s supplied with this system Do not use an extension cord or adapters with this system All units should sit on a hard flat stable surface Do not place them on surfaces that could allow them to tip over Caution Plug this equipment into grounded outlets only This reduces the risk of shock Note If the power outlets are not grounded an electrician will need to install grounded outlets before you can use this equipment outside of the hospital Note To avoid accidentally switching off the power to your VAD use outlets which are not connected to any wall or light switches Set up your equipment near outlets that meet these requirements Note Do not block fans or ventilation holes of the equipment Blocking these openings can cause heat to build up inside and damage the equipment MicroMed Cardiovascular Inc 16 5 2 5 3 5 4 The HeartAssist 5 VAD System Patient User s Ma
55. isplay on the Controller LCD display until the Controller Alarm Silence Button on the Controller is pressed or the alarms clear automatically Sleep Mode The HeartAttendant has a Sleep Mode for times when the patient is resting sleeping and may not want to see the Patient screen Select Sleep in the display bar at the top of the screen and the screen will go dark showing only Flow Date and Time See Figure 6 14 To exit sleep mode simply touch the display screen MicroMed Cardiovascular Inc 34 The HeartAssist 5 VAD System Patient User s Manual Figure 6 14 Sleep Mode Display 6 4 4 Battery Display Screen The Battery Display Screen informs the user about the current status of the batteries that are currently plugged into the front of the HeartAttendant There are no controls available Battery charging is automatic NO ALARMS SLEEP ALARM HISTORY Pel BATTERY BATTERY BATTERY BATTERY 1 2 3 4 77 PATIENT ID TEST1 LOW ROSE BATTERY 12 11 2009 5 08 PM L MIN WATTS L 2 NEN 3 mum mm K5 Figure 6 15 Battery Display Screen 5 7 MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 35 6 5 Hazards Be aware of the following hazards associated with the HeartAttendant 6 5 4 Grounding Before any connection to the Controller input is made the HeartAttendant must be connected to a protective earth ground via the three core mains cable supplied The mains plug should b
56. kup Notify MicroMed FUIS ieee DIBgnostic Alain te Cardiovascular Inc and request a replacement Controller 7 2 3 Fail Safe Alarm Fail Safe Alarm Fail Safe LED is lit high pitch continuous alarm is heard LCD display is frozen battery LEDs are lit The Pump is DISPLAY FROZEN running at 8500 RPM ACTION TO BE TAKEN Replace the Controller with the backup Controller Figure z AA FAESA AIRI 7 2 4 Controller Failure Alarm Controller Failure Alarm The LCD is off the LEDs are off and a high pitch No display for continuous emergency alarm is heard not a beeping alarm The Controller has failed internally The Pump this alarm has stopped Due to potential process failure there will be no display associated with the alarm Figure 7 25 Controller Failure Alarm ACTION TO BE TAKEN Replace the Controller immediately with the backup Controller e Contact the Support Team immediately to request a Controller replacement MicroMed Cardiovascular Inc 46 The HeartAssist 5 VAD System Patient User s Manual MicroMed Cardiovascular Inc on power The HeartAssist 5 VAD System Patient User s Manual 47 Section 8 0 Summary of Use 8 1 Quick Reference Alarms from the Controller Alarm What Happened What Do I Do Who Do I Call BATTERY 1 OR2 Battery 1 or 2 is See that the Battery is firmly seated Support DISCONNECTED disconnected from the in the VADPAK battery pocke
57. le or objects could damage the external HeartAssist 5 VAD System hardware injure internal organs or interfere with the tissue healing at the exit site You should consult your doctor before engaging in the following activities Consult Your Doctor Regarding Bathing or Showering Comments Prior approval of your doctor and a Shower Bag are required Driving an Automobile You must first get approval from your doctor In addition local laws may prohibit persons in your condition from operating motor vehicles Flying You must first get approval from your doctor In addition speak with the airlines about any special requirements that they may have Non Contact Sports i e golfing jogging tennis You and your doctor can determine whether participation in a certain sport may pose a danger either to yourself or to your HeartAssist 59 VAD equipment No Known Risk e Careful Sponge Baths e Sexual Activity e Housework Moderate Exercise i e walking gardening cycling Shopping MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 61 11 0 Self Care 11 1 Caring for the HeartAssist 5 VAD System While at Home 11 1 1 11 1 2 11 1 3 Exit Site The tube Percutaneous Cable coming out of your skin contains wires that connect the HeartAssist 59 VAD Pump to the Controller and allow the Pump and Controller to communicate The area where the VAD Pe
58. lence Button of the Controller and verify the flow rate RPMs and current are normal The alarm silencing will indicate a successful Pump restart Contact the Support Team immediately Figure 7 16 Diagnostic Alarm 5 Diagnostic Alarm 6 Battery 1 has been disconnected BATTERY 1 ACTION TO BE TAKEN DISCONNECTED Verify the Battery is firmly seated into the VADPAK battery pocket Verify the VADPAK battery pocket connector is firmly inserted into the Battery 1 Port on the Controller This alarm will clear automatically when a Battery is connected If alarm does not clear contact the Support Team Figure 7 17 Diagnostic Alarm 6 Diagnostic Alarm 7 The Battery plugged in VADPAK battery pocket 1 is BATTERY 1 discharged DISCHARGED ACTION TO BE TAKEN Replace Battery 1 with a charged Battery This alarm will clear automatically when the discharged Battery is replaced with a charged Battery Figure 7 18 Diagnostic Alarm 7 MicroMed Cardiovascular Inc 44 The HeartAssist 5 VAD System Patient User s Manual Diagnostic Alarm 8 The battery plugged in VADPAK battery pocket 1 has discharged below 15 or it s voltage is too low ACTION TO BE TAKEN Replace Battery 1 with charged Battery e Recharge expired battery This alarm will clear automatically when the discharged Battery is replaced with a charged Battery Diagnostic Alarm 9 The Battery plugged in VADPAK battery pocket 2 has been
59. m Patient User s Manual 63 12 1 12 2 12 4 12 0 Equipment Care and Maintenance Controller The Controller should always be placed in the VADPAK to promote proper cooling of the Controller and eliminate potential harm to you Caution Do not drop the Controller on any hard surface Dropping the Controller may damage internal components causing the device to malfunction HeartAttendant The HeartAttendant does not require routine maintenance Dust may be wiped off the surface of the device with a clean dry lint free cloth and spills may be cleaned from the cover with a dampened cloth To safely change fuses see Section 6 5 1 1 Mains Voltage Cord Mains Voltage Range and Fuses on page 35 Warranty and Service 12 4 4 HeartAttendant The HeartAttendant is under warranty for one year If the HeartAttendant fails to operate in the described manner contact your Support Team personnel for a replacement and return of the original for service Caution Do not service this equipment yourself Only qualified personnel can service this equipment If service is required contact your Support Team personnel MicroMed Cardiovascular Inc 64 The HeartAssist 5 VAD System Patient User s Manual Description MicroMed Part Number Fuse European M00438 04 Fuse North American M00438 05 Fuse Controller Power M00413 03 PHSS Contralles intecace Gable MOTOS HeartAttendant Controller Interface Cable M01507
60. ment 4 1 Temperature Conditions Do not operate the Controller where temperatures are less than 10 C 14 F or greater than 40 C 104 F Do not operate the HeartAttendant where temperatures are less than 10 C 50 F or greater than 40 C 104 F Do not store the system in environments where temperatures are less than 20 C 4 F or greater than 55 C 131 F The Batteries should not be exposed to moisture or heat The Controller and HeartAttendant should not be exposed to moisture The VADPAK carry bag is flame retardant but care should be exercised when used near open flame or embers Any hot item that falls onto or within the bag should be removed as quickly as possible to prevent scorching or marring of the materials 4 2 Contact with Liquids Caution 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 shock and of damage to the equipment 4 3 Electromagnetic Interference Laboratory testing suggests that there is little risk from most devices that may produce electromagnetic interference such as metal detectors microwave ovens and cellular phones The HeartAssist5 VADHeartAssist 5 VAD System has been shown to be safe from electromagnetic interference as defined by European standard IEC EN 60601 1 as well as US MicroMed Cardiovascular Inc 14 4 4 The Heart
61. ment of the child s device It may be helpful to provide a copy of this manual to school staff You and your child s teacher should evaluate playground and classroom areas to identify any situations that might cause harm to the child or his or her device lt may be useful to discuss your child s 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 the child s VADPAK straps or percutaneous cable during play Classmates and playmates should be reminded to seek adult help as soon as possible if your child doesn t feel well or passes out 14 5 3 Activities While on HeartAssist 5 Pediatric VAD support your child may not participate in swimming or contact sports activities This is to protect the safety and function of your child s device With your doctor s permission your child may participate in moderate activities like jogging golfing walking shopping etc with a low risk of harm to the device You should consult your doctor about whether or not your child should travel by car or plane If your child requires a car seat during travel you should be sure to position the VADPAK so there is no pull on the cables or the child s shoulder Seatbelts should not interfere with travel for older children in any case however they may be MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 75 14 6 more comfortable riding on the righ
62. n the moving flow window Power Power in Watts used by the Pump and Controller together excludes CPU and flow sensor power requirements Battery Displays the battery charge level as a percent of full capacity for battery 2 connected to the Controller in the VADPAK Display Select Buttons These buttons are used to navigate between the six HeartAttendant screens Select the desired button to move to that screen A password is required to change from the Patient Display and Battery screens to other screens Battery Status Indicators Four small icons across the bottom of the screen correspond to the batteries plugged into the charging slots below The number of MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 31 segments illuminated indicates the approximate charge level of the battery below it See bottom of Figure 6 7 6 4 2 Patient Display Screens The following screens are for the benefit and use of patients NO ALARMS IST Ej 8 5 5 8 5 6 78 PATIENT ID TEST1 SPEED FLOW POWER BA 12 11 2009 3 45 PM kRPM L MIN WATTS AA A Figure 6 8 Patient Display Screens Graphic Flow Display Plots VAD Pump flow in real time The time scale scrolls from left to right and covers a five second time span 6 4 2 1 Alarm Status Bar and Screens The following screens show the Alarm Status Bar with varying states of alarm status as well as the Current Alarms and Alarm History win
63. nc 76 The HeartAssist 5 VAD System Patient User s Manual person such as a friend or 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 caregiver or other individual knowledgeable in the operation of the HeartAssist 59 Pediatric VAD MicroMed Cardiovascular Inc
64. nt should be powered up The HeartAttendant Controller Interface Cable should be plugged into the HeartAttendant Note You can leave the HeartAttendant Controller Interface Cable plugged into the HeartAttendant at all times MicroMed Cardiovascular Inc 56 The HeartAssist 5 VAD System Patient User s Manual 10 2 2 Connect the HeartAttendant Interface Cable to the External Interface Port Visually align the slot on the cable connector with the red dot on the External Interface Port of the VADPAK The cable should be oriented so it is pointing upwards Once the slot and red dot are aligned firmly push the plug into the External Interface Port A slight click will be heard and felt as the connector becomes fully seated Note Damage can occur if the connector is forced without proper alignment After the connectors are aligned do not twist the connector plug while inserting fall connections are tight and all the components are working properly the Controller front panel will display DAS CONNECTED if using the HeartAttendant Controller Cable Note In the event that a power failure is expected to last for an extended period of time it is recommended that the patient take the HeartAttendant and all Batteries to the nearest location with suitable mains power Caution Batteries not being used in the VADPAK should always be charging in the HeartAttendant 10 3 Untethered Operation You will
65. ntroller Support AUDIBLE ALARM Team 8 2 Quick Reference Alarms on HeartAttendant Note The HeartAttendant does not have any audible alarms All audible alarms are only given from the Controller When connected to the HeartAttendant a flashing bar at the top of the screen denotes that one of the following two types of alarms has occurred 8 2 1 Emergency Alarm Red Flashing Bar A red flashing bar signals an emergency alarm given by the Controller as described in Section 7 2 1 Emergency Alarms on page 40 and shown in Figure 6 11 on page 32 VADPAK Connected to the HeartAttendant When the VADPAK is connected to the HeartAttendant the emergency Controller alarm can only be silenced for a few seconds by pressing the speaker icon at the top right portion of the screen The alarm repeats if the reason for the alarm remains The alarm cannot be silenced by pressing the silence button on the Controller When the MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 51 8 2 2 reason for the alarm has been resolved the audible alarm from the Controller will stop but the red flashing bar will continue to flash until the speaker icon is pressed VADPAK Not Connected to the HeartAttendant When the VADPAK is not connected to the HeartAttendant and an emergency alarm occurs it cannot be silenced by pressing the silence button on the Controller When the cause of the alarm has be
66. nual HeartAttendant Console The HeartAttendant console functions as the CDAS and the PHSS unite combined as one unit The HeartAttendant is designed to set Pump operating parameters communicate with the Controller and is the primary source of power for the duration of the implant The HeartAttendant also charges and reconditions batteries Controller The Controller is designed to be very reliable and easy to operate 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 may occur The Controller emits three distinct audible sounds The diagnostic alarm is a slower beeping sound The emergency alarm is a faster loud ringing two tone sound A Controller failure alarm is indicated by a continuous tone alarm The Controller contains two memory banks called Holter memories These memories record the performance of the Controller and the Pump Note Your Support Team personnel are responsible for programming the Controller Batteries The Batteries that power the HeartAssist 59 VAD are nickel metal hydride type DR36 smart Batteries Each Battery will power the VAD for approximately 2 5 to 4 hours with flow sensor disabled giving a combined Battery time of approximately 5 to 8 hours Each Battery contains an integrated charge indicator consisting of four green LEDs representing 25 charge increments see Fig
67. operational or not The Controller should be immediately replaced with the backup Controller The Controller is splashed with liquid Wipe the liquid from the case of the Controller If one of the battery ports is open tilt the Controller to allow the liquid to drain from the open port Warning DO NOT attempt to wipe the liquid from the inside of the battery ports as the connector pins may become bent or otherwise damaged Contact the Support Team immediately MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual Situation The Controller becomes soiled 67 Action The Controller can be wiped with a slightly damp cloth with mild detergent for example dishwasher soap Caution NEVER spray water or detergent directly on to the Controller Always apply water or detergent to a soft cloth wring out until just slightly damp and wipe Controller The Controller becomes submerged in liquid Replace the Controller immediately and Contact the Support Team immediately for an additional backup Controller A VADPAK battery pocket submerged in liquid Remove the Controller from the VADPAK immediately DO NOT disconnect from the VADPAK yet Locate a spare Battery Pocket and insert a fully charged battery into it Locate HeartAttendant Controller Interface Cable Verify that the HeartAttendant is powered up Remove the Battery 2 connection to the Controll
68. ory Window Current Alarms This window lists alarms as they occur while the HeartAttendant is connected to the Controller Alarms also cause the Alarm Status bar to flash Alarm conditions should be cleared as soon as practical after they occur in order to detect a recurrence of the same alarm Alarm History Alarms are listed in this window as they occur while the HeartAttendant is connected to the Controller MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 33 6 4 3 Possible Emergency Alarms Pump Stopped Both Batteries Disconnected VAD Disconnected Possible Diagnostic Alarms Controller Failure Excess Power Reduced Flow Rate Low Internal Battery Reduced Motor Speed Pump Restarted Battery 1 Disconnected Battery 1 Discharged Battery 1 Expired Battery 42 Disconnected Battery 2 Discharged Battery 2 Expired Acknowledge Alarms As alarms occur in the Controller they are transmitted to the HeartAttendant To clear the alarms from the status window and silence the Controller alarm press the Acknowledge Controller Alarms button Ba Figure 6 13 Acknowledge Controller Alarms button Note This action only silences the Controller audible signal the Controller alarm silence clear button must also be pressed to clear the alarm from the Controller s LCD and or LEDs Note The alarm messages continue to alternately d
69. oting 13 2 1 Situation The Controller LCD display is unreadable the Battery LEDs respond to Battery changes and the Fail Safe Mode LED is OFF It is likely the Pump is still running normally The HeartAssist 5 VAD System Patient User s Manual Non Pump Related Problems Action 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 active and you feel no adverse affects the Pump is probably still functioning correctly The Controller should be replaced with the backup Controller The Controller LCD display is unreadable the Battery LEDs respond to Battery changes and the Fail Safe Mode LED is ON Amber It is likely that the Pump is still running but at the Fail Safe Mode speed 8 5 kRPM Because the motor Controller is separate circuitry from the Controller CPU the Pump may continue to run in the event of a Controller failure however the watchdog circuitry that verifies the functionality of the CPU will detect a failure in the CPU and fix the motor Controller to the preset speed of 8 500 RPM The Controller should be replaced with the backup Controller The Controller LCD display is unreadable the Battery LEDs do not respond to Battery changes It cannot be determined if the Pump is
70. ould make sure your child s percutaneous cable is not prone to pull or disconnection at any point while the child is active Moreover the child should be taught not to play with the percutaneous cable or its connection to the VADPAK or Controller because doing so may increase the risk of injury or infection at the exit site or disturb connections Daily Operation 14 5 1 Leaving your house Your child should have fully charged Batteries whenever he or she goes away from your 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 a HeartAttendant should travel with your child so his or her Batteries may be charged and he or she will have 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 Pediatric VAD left ventricular support device This should also include the parent or caregiver s name and a method of contact as well as the name and phone number of the child s physician 14 5 2 Return to School It is expected that some children will return to school while on HeartAssist 59 Pediatric VAD support Before the child returns to school the school nurse and classroom teacher should receive training in the manage
71. probably want to use the Batteries in the VADPAK instead of the HeartAttendant while you are active This is called untethered operation You must have two fully charged Batteries in the VADPAK before you switch to the untethered mode The Controller will draw 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 25 capacity Each fully charged Battery will power the HeartAssist 5 VAD Pump for approximately 2 5 to 4 hours giving a combined Battery time of approximately 5 to 8 hours Higher Pump speeds may reduce Battery time The Controller front panel will tell you the percent capacity remaining for each Battery Each Battery is expected to last at least 200 charge discharge cycles Note The amount of time that you stay in untethered operation depends on the set Pump speed Warning Only use Batteries supplied by MicroMed Cardiovascular Inc MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 57 10 4 To Switch from Tethered to Untethered Operation 10 4 1 Before Disconnecting From the HeartAttendant Check that the capacity of the two Batteries connected to the Controller is nearly full gt 80 on the Controller panel If one or both are not proceed as follows Remove one or two fully charged Batteries from the HeartAttendant e Check the Batteries by pushing the char
72. r caregivers of pediatric patients of any age and children or adolescents with the appropriate skills should read this manual thoroughly before taking on care of the device This section does not repeat all of the cautions and instructions contained elsewhere in this manual and it should not be substituted for reading the entire manual 14 1 Implant Surgery The HeartAssist 59 Pediatric VAD will be placed in your child s chest with an operation Your child s doctor will explain the surgery to both of you When you and your child are ready after the operation to implant the device the hospital staff will train you and your child if he or she is old enough on how to operate the HeartAssist 5 Pediatric VAD 14 2 Description The Controller VADPAK SmartPak Batteries ChargePak and HeartAttendant that the pediatric patient will use are the same as described in Section 2 0 and 3 0 of this manual The pump your child will receive has been adjusted so it will fit better in a child s smaller chest The pump operates exactly like the adult pump Section 2 0 and 3 0 of this manual describe how the HeartAssist 59 Pediatric VAD pump works 14 3 Environmental Conditions 14 3 1 Temperature HeartAssist 59 Pediatric VAD system operation and storage is not recommended in certain environmental conditions Note Do not operate the Controller where temperatures are less than 10 C 14 F or greater than 40 C 104 F Your child must wear the Con
73. rcutaneous Cable comes out of your skin is called the exit site While in the hospital the exit site was bandaged to prevent infection Now your exit site prebably deesatmay not require bandaging but you still must prevent the skin around the exit site from breaking down The skin grown around your Percutaneous Cable forms a barrier to infection Consult your physician for exit site bandaging instructions As you clean the exit site each day examine it for signs of infection such as Redness Swelling Drainage Presence of an Open Sore or Ulcer Pain Warm to Touch If any sign of infection or break in the tissue is present contact your doctor immediately VADPAK The VADPAK is an ergonomic storage system designed to allow the patient to carry the Controller and Batteries If you are going for a walk disconnect the HeartAttendant and connect to the VADPAK ensuring that it contains charged Batteries Medications Your doctor may prescribe an anticoagulant such as warfarin Coumadin and may prescribe other drugs to take while you are on the HeartAssist 5 VAD support It is MicroMed Cardiovascular Inc 62 The HeartAssist 5 VAD System Patient User s Manual important that you take these and other medications according to your doctor s instructions Please contact your doctor with questions about your medications MicroMed Cardiovascular Inc The HeartAssist 5 VAD Syste
74. s not start and message does not clear when Alarm Silence Button of the Controller is pressed or the alarm does not clear automatically replace the Controller with backup Controller The VAD Pump is disconnected from the Controller VAD ACTION TO BE TAKEN DISCONNECTED Unscrew the White Defibrillation Insulator from the AEC Remove the Pump Percutaneous Cable plug from the Paura t 17 Semorgene y Alarm s RAEC Plug the Pump Percutaneous Cable plug back into the RAEC making sure it is fully seated in the RAEC mating connector Verify the Pump has restarted successfully If pump does not start and message does not clear when Alarm Silence Button of the Controller o pressed or the alarm does not clear automatically replace the Controller with backup ontroller Screw the White Defibrillation insulator onto the RAEC mating connector If Pump does not start and message does not clear when the Alarm Silence Button is pressed replace the Controller with backup Controller Contact the Support Team immediately MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 7 2 2 Diagnostic Alarms Diagnostic Alarm 1 The VAD Pump is drawing current power in excess of the programmed alarm value EXCESS CURRENT Note This alarm does not silence or clear automatically The Controller Alarm Silence Button must be pressed to silence and clear this alarm Figure 7 12 Diagnostic Alarm 1 ACTION TO
75. ssseeeees 28 6 9 Recharging Batterigs on ences dd di 28 MicroMed Cardiovascular Inc iv The HeartAssist 5 VAD System Patient User s Manual 6 4 Description of SOLOS treacle osa tt dto ei t 30 6 4 1 Displays Common to All HeartAttendant Screens ssses 30 6 4 2 Patient Display Screens aaa lord a atados 31 643 Sleep Mode taa dit o ce ela 33 6 4 4 Battery Display Screeri ise amd ti tirada ds 34 65 Hazard aos 35 6 51 GOW IF edecanes 35 7 0 The Controller Front Panel Display Alarms and Troubleshooting 37 7 1 Standard Messages Seven Scrolled Information Screens 0cocccnnnocicnnccocccnonancccnnnnacnninnnns 38 Le AMOS e 40 49 1 Emergency O A en aaea inaipa 40 22 2 Diagnostic Alar MS osse iii 42 7 2 3 Fail Safe o d PC neee Se cones 45 7 2 4 Controller Failure Alarm utet cre odo ee eee 45 8 0 Summary OF USE P 47 8 1 Quick Reference Alarms from the Controller ccccceeseeeeeeeeccceeeeeneeeeeeeneeeeeeeaaeeeeee 47 8 2 Quick Reference Alarms on HeartAttendant c ccccssessssssessessessessesseseessesecsseteeveneees 50 8 2 1 Emergency Alarm Red Flashing Bat 2 ccccceeeseeecceeeeeeeeeeeeeeeeeeeeeeeeneeeees 50 8 2 2 Diagnostic Alarm Yellow Flashing Bar eese 51 9 05 Dally Chec kS cud iac iu as oret FAR aue SA e CH Ful a SEN nun evel aaa 53 9 1 Daily Checks Using the HeartAttendant
76. ssword Below the display are the four battery charging slots that hold the custom DR36 style batteries used by the HeartAssist 5 VAD Below the battery ports is the connector dedicated to the Controller using the Patient Interface Cable Components inside the unit include a computer patient isolation board battery charger and conditioner power supply and toroid isolation transformer MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 9 3 5 Figure 3 5 The HeartAttendant Console VADPAK After implantation of the HeartAssist 59 VAD you will be able to carry the Controller and Batteries using the VADPAK an ergonomically designed wearable system that enables the patient to be mobile The system is comprised of four integrated components A plastic housing which provides structural form protection and secures all of the other components A smart battery interface board which allows for the quick connection and disconnection of power and control devices via an external interface connector This unit provides automatic switching from battery 1 of the Controller to an approved power supply or control device when the power supply or control device is connected via the External Interface Port The External Interface Port see Figure 3 6 allows connection to an approved external power source or control device without the need to disconnect the Battery cables within the VADPAK A protective pouch with
77. ste eed 39 Default Screen B cox reme e Tuae aed irs c e ees 39 Berault Screen 7 uten riim anie rolas lanos R P 40 Errergerney Alarm s seta teres AS URERSSR BA Shire ES A I 40 Emergency Alarm 20003 erus bes ey EIe Ceiba Rea edd y ace woe AS 41 Emergency Alanis 8 Lenses ern uis dne ce 8 toca E coed M Dread M c cua DE 41 Diagdosuc Alam T uses m SpA Race ES SERES ia kode at eec Baw BS ades 42 Di gnostic Alarm 2 aosta PCI EL DM 42 Diagnostic Alarm 3 uo v e A ba ee ra 42 Diag stic AIMAR a 43 Diagnostic Alarm S aces scs y AA diee ed S e eae arcas 43 Diagnostic Alarme sio darte Foy a DR ROM ROLL SDN Eo tine dne vig dea ch 43 Diagnostic Alarm 7 ivre ERR Ou prefix RE Eae rus UU UE P Vind 43 Diagnostic Aat Bait ena e a ovaries salem sis oe OCDE NR ROC EE 44 Diagnostic Alarm 9 eset se E VA A dae be P ree duced vias 44 Eiagnosuc ALANNA Wars cix P oe e dao deed e tne kun de e ea e Bev tate Bre gg ae 44 Eidgnosuc Alarm T asi sos exu Ata Be side tii i da 44 Bi gnostc Alarm 12 xc bes eT ss Qe 45 Fail Safe Alarm o oom ate o e me Me meras d oco 0 stude Loa d e e to Dk 45 Controller Failure Alarm u i eiim abides ah tae RR PR ae Peri 45 10 0 Daily Operation Figure 10 1 Figure 10 2 Figure 10 3 Using the VADPAK and Shower Bag Step2 0 00 cece eee 58 Using the VADPAK and Shower Bag Step3 00 eee eee 59 Using the VADPAK and Shower Bag Step 4 lllllllles elles 59 MicroMed Cardiovascular Inc
78. t Team Controller BATTERY 1 OR2 There is no power left 1 Replace the Battery with a Support EXPIRED in Battery 1 or 2 charged Battery Team 2 Press the Alarm Silence Button of the Controller BATTERY 1 OR2 There is not enough 1 Replace the Battery with a Support DISCHARGED power left in Battery 1 charged Battery Team or 2 2 Press the Alarm Silence Button of the Controller BOTH BATTERIES Both Batteries are 1 See that the Batteries are fully Support DISCONNECTED disconnected seated in the VADPAK battery Team pockets 2 Seethat the VADPAK battery pocket cable connectors are cor rectly inserted into the Controller ports 3 Seethat the VADPAK battery pocket cables are not cut or dam aged 4 Seethat at least one of the Bat teries is charged EXCESS The VAD Pump Patient must return to the hospital for Support CURRENT current is above the one or more Excess Current Alarms Team alarm value which cannot be cleared in 10 minutes or for multiple Excess Current Alarms over a period of more than 10 minutes but less than 24 hours LOW INTERNAL The internal battery of Contact the Support Team Support BATTERY the Controller is low Team MicroMed Cardiovascular Inc 48 Alarm The HeartAssist 5 VAD System Patient User s Manual What Happened BATTERY TOGGLING BETWEEN BATTERIES 1 AND 2 ACCOMPANIED BY NUMEROUS SHORT AUDIBLE BEEPS A Battery has experienced a prematurely low voltage What Do I Do 1 IF POSSI
79. t Controller into the larger pocket Connect battery cables P1 and P2 to Controller see Figure 5 5 4 Verify the Battery capacity by pressing the scroll display button on the front panel of the Controller Each battery connector is labeled to help you identify which corresponds to the Battery charge shown on the Controller display see Figure 5 5 Battery Connector 1 P1 c3 v e Battery Connector 2 P2 Figure 5 5 Battery Connector Cables 5 Secure the Batteries with the narrow hook and loop strap see Figure 5 6 MicroMed Cardiovascular Inc 22 The HeartAssist 5 VAD System Patient User s Manual Hook and Loop Fastener xt ES EA AERE Figure 5 6 Battery Fastener 6 Close the cover of the VADPAK see Figure 5 7 Note Secure the top cover of the VADPAK carry bag using the hook and loop strip 7 When relaxing or before sleeping connect the HeartAttendant Controller Interface Cable into the External Interface Port see Figure 5 8 Make sure the VADPAK material does not inhibit the connector from being fully seated in the External Interface Port 8 Verify that the HeartAttendant is supplying power to the Controller by checking that the green LED on the Controller is lit Figure 5 7 Closed VADPAK Cover MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 23 5 6 External Interface Port et Figure 5 8 External Interface Port Connection No
80. t side of the vehicle where the belt buckles connect on the left because the percutaneous cable and VADPAK are located on the right side of the body 14 5 4 Bedtime When sleeping your child should be tethered to the HeartAttendant so that there is a continuous power supply and the child does not have to be awakened to change Batteries It will be important for you to arrange your child s room so that he or she can take the VADPAK off while sleeping yet keep it close by so the percutaneous cable connection will not be stretched You should put things the child may need at night in close reach because their connection to the VADPAK limits the distance they can safely move Many children like a glass of water at their bedside use of a non spillable cup to prevent liquid from entering the VADPAK Controller or Batteries is recommended 14 5 5 Bathing Children supported by the HeartAssist 59 Pediatric VAD may not take a bath because the VADPAK Controller 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 must be fully enclosed in the Shower Bag as described in Section 9 0 of this manual Emergencies An emergency situation may be caused by conditions requiring medical care or by a mechanical problem that interferes with the pumping ability of the HeartAssist 59 Pediatric VAD It is important to learn how to identify an
81. te All of the MicroMed Cardiovascular Inc external power and control devices i e Fail Safe Dongle should only be connected via the External Interface Port The battery cables connected to the Controller should never be removed unless the Controller or VADPAK needs to be changed Note The hook and loop flap and the interface port cap on the side of the VADPAK carry bag should be closed over the External Interface Port whenever it is not in use Controller Replacement In the event that the Controller needs to be changed have a caregiver assist if possible in the following steps 1 Sit or recline for this procedure Note It is normal for the Controller to alarm during this process 2 Ensure that both Batteries in the VADPAK are charged 3 Unscrew the White Defibrillation Insulator from the Right Angle Extension Cable RAEC see Figure 5 9 for component descriptions MicroMed Cardiovascular Inc 24 The HeartAssist 5 VAD System Patient User s Manual Disconnect the connector for VADPAK Battery Pocket 1 from the Controller currently in the VADPAK Connect this cable to the top connector of the new replacement Controller Ensure the replacement Controller has power Leave Battery properly seated in pocket Connector fully inserted mated The sliding barrel is in the locked position White Defibrillation Insulator Hold Here Hold Here as ias au Pull in Opposite Directions Strain Relief DO NOT
82. troller at all times or the child s pump will not run Therefore you should not allow your child to spend time in areas with temperatures outside this range or to place their Controller in locations where this temperature range may be exceeded e g heaters radiators air conditioners MicroMed Cardiovascular Inc 72 14 3 2 14 3 3 The HeartAssist 5 VAD System Patient User s Manual Note The SmartPak Batteries Controller and VADPAK should not be exposed to moisture or heat Whenever your child is mobile or operating in the un tethered mode i e child is operating pump on Batteries alone he or she will have two Batteries and the Controller in the VADPAK These Batteries and Controller must not get wet so you should not allow your child to swim or play in water such that moisture may enter the VADPAK and come in contact with either the Batteries or Controller On days with heavy rains it might be helpful to make sure the child is wearing rain gear or the Shower Bag to protect the VADPAK Controller and Batteries as he or she goes outside The Batteries also should not be exposed to extreme heat Care should be taken when the child is playing in very hot environments like at the beach Young children should not stand in front of or come in contact with sources of heat such as fireplaces space heaters stoves etc As a reminder your child s PHSS HeartAttendant and ChargePak should never be placed close to these types o
83. ure 5 1 To activate the Battery indicator press the circular button below the LEDs Four LEDs representing 25 charge increments Figure 5 1 Battery Charge Indicators Note Battery time may vary from patient to patient depending on set Pump speed Warning Only use Batteries supplied by MicroMed Cardiovascular Inc 5 4 1 Connecting a Battery Cable to the Battery Port The two Battery ports for the Controller are color coded black and keyed so that only the HeartAttendant the VADPAK Battery plugs the backup Battery Pocket or the MicroMed Cardiovascular Inc The HeartAssist 5 VAD System Patient User s Manual 17 Fail Safe Dongle can be inserted To insert the Battery cable into the Controller follow the steps below 1 Locate the red dot on the Controller port 2 Locate the sletarrow on the VADPAK Battery Pocket Cable plug 3 Visually align the sletarrow on the VADPAK Battery Pocket Cable plug with the red dot on the Controller port 4 Once the sletarrow and red dot are aligned firmly push the plug straight in the Controller port A slight click will be heard and felt as the connector becomes fully seated Alternately if the sletarrow and red dot cannot be aligned visually the plug can be gently inserted 2 mm 1 16 of an inch with very little pressure applied rotated until it mates with the port and no longer rotates freely At this point the connector is firmly pushed straight in the port until it is
84. usly Caution Even when connected to an external power supply the Batteries located inside the VADPAK will drain and lose capacity over time The user should ensure that these two Batteries are always as close to fully charged as possible The capacity of these Batteries can be determined in the fell owingAvaysas follows 1 e When the Controller is connected to the HeartAttendant the percent capacity of Battery 2 will beis shown on the patient display Screen ESaiteby i capacity ecan be soheeked as dotalod above Battery 1 can safely be removed from the VADPAK Battery Pocket and the capacity can be checked via the Battery charge indicator LEDs MicroMed Cardiovascular Inc 20 The HeartAssist 5 VAD System Patient User s Manual 5 5 VADPAK The VADPAK is an ergonomically designed wearable pouch that will enable you to be completely mobile see Figure 5 3 Figure 5 3 The VADPAK 5 5 1 To Manage the VADPAK 1 Insert two 2 fully charged Batteries into the VADPAK Battery bays one Battery in each bay see Figure 5 4 Note There should always be two 2 Batteries in the VADPAK Battery bays one in each bay except when changing batteries Figure 5 4 VADPAK Battery Bays MicroMed Cardiovascular Inc The HeartAssist 59 VAD System Patient User s Manual 21 2 To ensure that the Battery is securely inserted into the Battery bay press down on the Battery until you feel it click 3 Inser

The HeartAssist 5 ® VAD System Patient User`s Manual

Contents

Download Pdf Manuals

Related Search

Related Contents

The HeartAssist 5 &reg; VAD System Patient User`s Manual

Contents

Download Pdf Manuals

Related Search

Related Contents

The HeartAssist 5 ® VAD System Patient User`s Manual