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HeartWare Ventricular Assist System Instructions for Use

1. Controller Language Disable VAD Stop Set Alarm Defaults O A S S d E Setup Control d Figure 35 Disable VAD Stop Alarm 43 HeartWare Ventricular Assist System Instructions for Use Figure 36 Pending VAD stop command 10 4 2 4 Monitor Tab The Monitor tab is used to enter the date and time and to calibrate the monitor touch screen Figure 37 This version of the HeartWare Monitor supports English language only e Monitor Date and Monitor Time These buttons set the date and time on the monitor e Language Set to English e Touchscreen Use this button to initiate touch screen calibration for the monitor The monitor will only initiate the calibration sequence if the controller is NOT connected to the monitor Controller Monitor 10 09 09 08 59 English Calibrate l Alarm 4 f Settings HeartWare Figure 37 Monitor tab 10 4 3 Alarm Settings Tab The Alarm Settings tab Figure 38 is used to set the Low Flow Alarm and High Power Alarm thresholds Both flow and power are time averaged values not instantaneous values The Low Flow Alarm threshold may be set from 1 L min to 9 9 L min in 0 1 L min increments The Low Flow Alarm should be set at 2 L min below the patient s average flow Do not set the Low Flow Alarm below 2 L min The High Power Alarm may be set from 1 0 Watts to 25 0 Watts in increments of 0 5 Watts Default settings are 1 L min
2. 19 4 Battery Charger Once a week e Inspect the battery charger for signs of physical damage such as dents chips or cracks DO NOT use the charger if it shows signs of damage Contact HeartWare for a replacement e Inspect the power cord used to connect the charger to an electrical outlet Make sure the cord is not kinked split cut cracked or frayed Do not use the cord if it shows signs of damage Contact HeartWare for a replacement Periodically or as needed Unplug the charger from the wall electrical outlet and clean the exterior surface of the charger using a clean dry cloth To clean the battery charger remove the batteries and unplug the charger from the electrical outlet DO NOT place the charger in water or liquid WARNING NEVER clean the battery charger with the power on as this may lead to an electrical shock 19 5 HeartWare Monitor Once a month If not in use check to be sure the monitor is plugged into an AC outlet This will keep the internal monitor battery charged If the monitor battery fails to hold a charge or lasts less than one hour please contact HeartWare for a replacement Also check the monitor AC adapter and power cord for wear or damage and confirm they are working correctly Turn off the monitor prior to cleaning Clean the monitor screen with a soft lint free cloth A damp cloth may be used but a wet cloth should not Use care to avoid scratching or damaging the screen WARNING NEVER cl
3. 2 0 to 10 0 L min gt 10 L min greater than 10 L min The error of the estimated flow is the maximum of either 1 L min or 20 whichever is greater Flow estimation accuracy can be maintained only if accurate hematocrit values are entered Out of range values on the low side less than 2 0 L min are invalid in terms of estimated flow but could indicate an incorrect hematocrit value used in the flow calculation Out of range values on the high side greater than 10 L min may occur due to thrombus or other materials e g tissue fragments in the device or due to an incorrect hematocrit value used in the flow calculation NOTE Flow estimation should only be used as a trending tool Actual flow may differ from readout due to variability of patient s hematocrit WARNING DO NOT rely only on flow estimation to assess cardiac output An average estimated flow on the monitor or controller display of less than 2 L min or greater than 10 L min may indicate an electrical fault incorrect hematocrit entry or an occlusion due to thrombus or other materials e g tissue fragments in the device Inaccurate assessment of HVAD Pump flow may lead to less than optimal treatment Ventricular Suction Detection Alarm A suction condition may occur due to ventricular collapse or inflow occlusion Ventricular collapse occurs when a continuous flow VAD attempts to pump more blood from the left ventricle than is available resulting in cons
4. Table 11 Of the patients who were implanted as of the cutoff date of May 6 2012 82 of 178 sintered HVAD patients 46 1 and 91 of 140 Control patients 65 0 had been implanted at least 180 days prior to the cutoff date Since pumps with sintered inflows are the only pumps marketed under this PMA by HeartWare results for these HVADs are compared to the control device 19 HeartWare Ventricular Assist System Instructions for Use Table 11 Select Adverse Events from ENDURANCE Trial to 180 days Post Implant Data cut off May 6 2012 Site Reported Event HVAD Sintered Control 0 180 Days n N n N Death 14 0 25 178 13 6 19 140 Neurological events Device Exchange 3 9 7 178 5 7 8 140 Device Thrombus 2 8 5 178 7 1 10 140 17 3 178 57 8 140 Med Treated 1 1 2 178 1 4 2 140 Bleeding requiring 11 8 21 178 12 9 18 140 re operation Bleeding requiring transfusion 2 4 units 15 2 27 178 19 3 27 140 within 7 days post AES 271140 implant 20 HeartWare Ventricular Assist System Instructions for Use SECONDARY ENDPOINTS Overall survival in the HeartWare group was 94 3 132 140 in the safety population and 91 2 in the control group at 180 days as displayed in Table 12 Table 12 Overall Survival at 180 days HeartWare System INTERMACS N 140 N 499 Survival at 180 Days N N Safety Population Survival 132 140 94 3 455 499 91 2 8 140 5 7 44 499 8 8
5. a Change Speed NOTE Disable Suction Detection y tas 700 A eme Z2 UD l A Sx On Q i 2 HWII234867 POD 0 15 34 00 1 Q10 2 HeartWare Figure 32 Dialog box for pump speed changes 10 4 2 3 Controller Tab The Controller tab Figure 33 allows the user to enter the controller date and time set the controller default values and activate the Disable VAD Stop Alarm feature 41 HeartWare Ventricular Assist System Instructions for Use Controller Montor Date Controller Time Controller Language Disable VAD Stop HeartWare Figure 33 Controller tab Press the Controller Date and Controller Time buttons to enter the controller date and time respectively Set Defaults The Set Defaults Figure 34 button sets the controller parameters to the original manufacturer settings listed below e Set Speed is 2500 RPM e Low Flow Alarm threshold is 1 0 L min e High Power Alarm threshold is 16 Watts e Suction Response is Off e Data Log Interval 15 minutes e Hematocrit is 30 NOTE A controller reset removal of both power sources is required following a Set Defaults command for the command to take effect VAD OFF Controller Controller Date 10 09 09 Controller Time Set Defaults Disable VAD Stop Alarm A omm Setup Settings HW1234567 POD 3 02 06 21 1 II 2 HeartWare Figure 34 Default setting 42 HeartWare Ventri
6. Pump Cross clamp two 2 sections of the outflow graft Cut outflow graft between two 2 clamps Cut and remove the percutaneous driveline Excise the remaining outflow graft from the aorta and repair the arteriotomy site Use the sewing ring wrench to loosen the sewing ring screw Remove the HVAD Pump For pump exchange refer to section 16 5 LV Apex Cannulation starting at step 6 For myocardial recovery follow the steps below Repair the hole in the LV Close sternum and skin incision per routine Once HVAD Pump is explanted rinse gently with NaCL Place HVAD Pump in 5 Formaldehyde for at least 2 days Allow the HVAD Pump to thoroughly dry Follow the packaging instructions provided in the Explant Kit provided by HeartWare and return the HVAD Pump in the Explant Kit HeartWare Inc Quality Assurance Department 14000 NW 57th Court Miami Lakes FL 33014 USA 18 0 PATIENT MANAGEMENT 18 1 Postoperative Management After implantation the patient is returned to the intensive care unit Fluids are given to maintain pump flow index pump flow BSA at greater than 2 0 L min m with central venous pressure and left atrial pressure less than 20 mmHg Some vasopressor and or vasodilatory pharmacologic assistance can be used as required to adjust vasomotor tone Patients may require inotropic assistance to improve right ventricular function 76 18 2 18 3 HeartWare Ventricular Assist System Instruction
7. Renal Dysfunction 7 5 0 1 0 7 2 1 4 3 2 1 a l i 1107 4 procedures were not included elective hysterectomy elective repair of hemorrhoids HVAD exchange and RVAD placement Transfusion criteria include gt 20cc kg packed red blood cells PRBC within any 24 hour period during the first 7 day post implant and any transfusion of packed red blood cells PRBC after 7 days following implant with the Investigator recording the number of units given Two cases were excluded 1 case hemolysis lt 72 hours post implant 1 case hemolysis occurring in the presence of tPA Integrillin for VAD thrombosis 1 7 2 3 5 3 6 4 4 2 9 1 0 7 4 1 1 1 1 0 7 The majority of infections did not involve the driveline or cause sepsis The local non device category encompasses a host of sites including the urinary tract lungs sinuses IV punctures colon and skin Infections involving the driveline exit site were more common after hospital discharge gt 30 days Similarly subjects were somewhat more likely to experience sepsis from 31 180 days 5 0 of subjects than perioperatively 2 1 Nearly a third 11 32 of the supraventricular arrhythmias were bouts of atrial fibrillation requiring drug therapy Nearly all the ventricular arrhythmias were ventricular tachycardia AICD shocks were recorded in 24 29 episodes of ventricular arrhythmia and 2 29 received external cardioversion Nearly all patients with a
8. Suction Detection Level The ventricular suction detection alarm can only be activated from the System Screen of the monitor Therefore only the clinician has access to control the state of this alarm The default setting for Suction Response is off In this mode there will be no alarm during a ventricular suction condition An Sx Off message will be displayed on the lower left hand corner of the monitor screen below the Fixed mode display When Suction Response is enabled via the Alarm button the Sx On message will be displayed on the lower left hand corner of the monitor screen below the Fixed mode display NOTE Whether or not the ventricular suction detection alarm is enabled Sx On or is off Sx Off can only be determined with the monitor it cannot be determined from the controller The Suction Response Alarm mode must not be turned on if the patient is in a suction condition If the mode is turned on during a suction condition the Sx On message will be displayed on the monitor and the ventricular suction detection alarm will be enabled but will be inaccurate due to the fact that normal baseline parameters could not be established during a suction condition The algorithm attempts to establish a baseline detection level to distinguish abnormal conditions This is not possible if the patient is experiencing ventricular suction when the algorithm is initiated Once the suction co
9. E 2 Figure 19 Power supply indicators 10 1 Clinical Home Screen Press the Home fa Icon to access the Clinical screen The Clinical Screen Figure 20 displays a real time power Watts waveform and a real time estimated HVAD Pump blood flow waveform L min Waveform time scales may be selected for 10 seconds 20 seconds or 60 minutes 34 HeartWare Ventricular Assist System Instructions for Use Power Watts Flow L min gt HW1234567 POD e 22 43 56 14 di 1 HeartWare Figure 20 Clinical Screen 10 2 Alarm Screen The Alarm Screens Figure 20 and Figure 21 are accessed by pressing the Alarm Lal Icon e A WHITE Alarm Icon is displayed for no alarms or for a low priority alarm e A YELLOW Alarm Icon indicates an active or resolved medium priority alarm e A RED Alarm Icon indicates an active or resolved high priority alarm condition If there are multiple alarms the Alarm Icon will indicate the highest priority alarm The Alarm Icon will not return to a white color until the icon is pressed after resolution of the alarm condition The Alarm Screen has two tabs Alarm Log and Troubleshooting The Alarm Log Figure 21 provides access to the alarm information The controller is designed to store 200 alarm entries on a first in first out basis The Alarm Log displays the date and time when each high or medium priority alarm occurs and when the alarm resolves Pump param
10. HeartWare Leading a small revolution HeartWare Ventricular Assist System Instructions for Use Caution Federal law restricts this device to sale by or on the order of a physician HeartWare Ventricular Assist System Instructions for Use TABLE OF CONTENTS LO INTRODUCTION ficiicsiccccexesecutwswsssasueeweunulsosdesucsa E i E 1 2 0 INDICATIONS FOR USEcciiiinida indias 2 3 0 CONTRAINDICATIONS eiennenn enade inaianei ova aeaa eaa aa ENa aaea saai 2 40 AWARNIN isa A A A a 2 5 0 PRECAUTIO NN Santana ii ii 6 6 0 POTENTIAL COMPLICATIONS conri aia 8 7 0 CLINICAL TRIAL RESULTS 00 oia dias 9 dE PINOTAECUN CAES TUDO DESIGN aaa 9 2 STUDY OBJECTIVES sti ocios 9 7 3 STUDY POPULATION DEMOGRAPHICS AND BASELINE PARAMETERS oocccooccconocnconocnconcnnnononcnoncnnonrnnonarnnonananonoss 9 HA SREETY AND EFFECTIVENESS REUS ica 11 7 5 OVERALL CONCLUSIONS FROM CLINICAL DATA sssssssccccceessssssaeeececessssssaeeeeccesssessaaaeeeeeesseeessaaeeeeeseesns 24 3 0 SYSTEM COMPONENT OVERVIEW siseosas nnana a aa aa aia aa 24 81 JHEARTIWARE VENTRICULAR ASSIST SYSTEM ias 24 32 JHEARTVVARE CONTROLLER acantilado aesculus satasisaeteedensenesesiusadsasnvonbeeuacs 25 Soy TABARIVV ARE MONTO aaa ae 25 8 4 HEARIWARE CONTROLLER POWER SOURCES cnn oia 25 8 5 HEARTWARE BATTERY CHARGER cd a Er O aaa 26 8 6 EQUIPMENT FOR IMPLANTA tds 26 90 PRINCIPLES OF OPERA TIO Ninaiiiinp sn ria A ds 27 Fi
11. PEEK is a registered trademark of Victrex plc Absylux is a trademark of Westlake Plastics Company IEC 60601 1 Classifications Type of protection against electric shock AC adapter Class DC adapter Class Il Controller Class Il Internally Powered Battery charger Class Monitor power adapter Class Degree of protection against electric shock Type CF Defibrillation Proof Applied Parts Degree of protection against the ingress of water IPX7 controller battery pack IPX5 driveline extension cable IPX2 AC adapter monitor power adapter data cable IPX1 monitor IPXO battery charger DC adapter 89 HeartWare Ventricular Assist System Instructions for Use Recommended environmental conditions for general use e Temperature range within 102C to 312C 50 F to 88 F e Relative humidity range within 30 to 75 e Atmospheric pressure range within 700 to 1060 hPa 20 70 to 31 30 in Hg Environmental conditions for transport and storage e Temperature range within 402C to 702C 40 F to 158 F for monitor data cable battery charger driveline extension cable and power adapters e Temperature range within 20C to 50C 4 F to 1222F for controller battery transport only e Temperature range within 20C to 25C 4 F to 772F for battery storage only e Relative humidity range within 10 to 90 e Atmospheric pressure range within 500 to 1060 hPa 14 76 to 31 30 in Hg The box lab
12. Per Protocol Population Survival 130 137 94 9 455 499 91 2 7 137 5 1 44 499 8 8 Survival differs from the primary analysis of success in that subjects who have a device exchange are not censored at the time of exchange but continue to accrue time until the endpoints of transplant death or explant for recovery QUALITY OF LIFE KCCQ AND EUROQOL Kansas City Cardiomyopathy Questionnaire KCCQ At baseline 128 140 91 4 patients were able to complete the KCCQ and at month 6 there were 88 patients available to complete the test 39 had received a transplant six had died seven had met an endpoint receiving a device exchange Table 13 Of the 88 patients available for assessment 74 patients had data at month 6 Reasons for missing the month 6 data included 9 of 14 with poor compliance missed visit 8 of 9 of these from a single site and 1 of 9 had a prior ICVA with MRS score of 2 2 were too sick 1 had no form available 1 had been transplanted within the 14 day visit window and 1 had refused Seventy patients 70 had both baseline and month 6 data For these 70 patients who were on HVAD therapy continuously for 180 days had a 31 point improvement in KCCQ Overall Summary Score over the 180 day period 21 HeartWare Ventricular Assist System Instructions for Use Table 13 KCCQ Overall Summary Score KCCQ Baseline cnange mom Baseline Mean SD 34 9 18 9 67 5 20 4 30 9 26 5 Min Max 0 0 84 1 19 3 100 0 49 4
13. 0 8 0 7 162 1 Alive original device in place a 0 6 Oo 0 5 0 4 4 na 128 6 Transplant original device in place 0 2 o 0 1 15 0 Device Exchange 0 0 E A 4 3 Death original device in place 0 60 120 180 240 300 360 Days Post Implant Deaths There were eight subject deaths during the 180 day study period Six deaths occurred in subjects with their originally implanted device and two deaths occurred after device exchange Safety Results This study was not randomized and used a contemporaneous control for the sole purpose of comparing a pre defined success outcome The adverse events reported here are unique to the HeartWare System and have no randomized comparator arm Exposure The total support exposure on the original HeartWare System was 20 698 days or 56 7 patient years The mean duration on device for the 140 subjects was 147 8 days standard deviation 52 8 witha median 180 range 6 180 days The mean duration on study was 222 5 days standard deviation 119 with a median of 196 range 11 588 days Duration on study exceeds duration on device because the follow up post transplant is included Adverse Events A total of 776 events Table 3 were reported by investigators during the 180 day period on the original device Of these 437 437 776 56 3 were INTERMACS defined specific events and 338 776 43 6 events were recorded under the INTERMACS category of Other One UADE was rep
14. 44 HeartWare Ventricular Assist System Instructions for Use for Low Flow and 16 Watts for High Power The High Power Alarm should be set 2 Watts above the patient s average power If the flow drops below the low flow threshold e g 1 L min or the power exceeds the high power threshold e g 16 Watts an alarm is triggered Clinicians should set the Low Flow and High Power Alarm thresholds close to the patient s flow and power values respectively NOTE The Low Flow Alarm should be set at 2 L min below the patient s average flow DO NOT set the Low Flow Alarm below 2 L min NOTE The High Power Alarm should be set 2 Watts above the patient s average power Low Flow Alarm Limit L min High Power Alarm Limit Watts Speed eos Alarm an i s tu i Control ne Settings y HW1234567 POD 1 qi 11 e 00 11 09 1 2 Figure 38 Alarm settings tab When certain alarm or fault conditions exist the Alarm Settings tab may be used to access additional controls to silence the audio component of the alarm or fault for extended time periods The Controller Fault Audio button appears during a medium priority Controller Fault alarm Figure 39 The Controller Fault Audio button can be used to permanently silence a controller fault alarm However the controller and monitor will continue to display the controller fault alarm until the condition resolves Low Flow Alarm Limit L min High Power Alarm Lim
15. 80 5 95 CI 31 6 38 2 62 8 72 2 24 6 37 3 European Quality of Life EuroQol At baseline 130 140 92 9 of patients were able to complete the test and at month 6 there were 88 patients available to complete the test 39 had received a transplant six had died seven had met an endpoint receiving a device exchange Table 14 Of the 88 patients available 75 had data at month 6 Reasons for missing the month 6 data included 9 of 13 with poor compliance missed visit 8 of 9 of these from a single site and 1 of 9 had a prior ICVA with MRS score of 2 2 were too sick 1 had been transplanted within the 14 day visit window and 1 had refused Seventy two patients 72 had both baseline and month 6 data showing an improvement of 30 points over the 180 day period Table 14 EuroQol EQ 5D Summary of Quality of Life Baseline Change uon Baseline Overall Summary Score CO o a o a o aR FUNCTIONAL ANALYSES 6 MINUTE WALK 6 Minute Walk Of the 132 patients assessed for the 6 minute walk test the mean distance walked was 89 4 meters Seventy Five 75 of the 88 patients on pump at month 6 completed the test Table 15 and Figure 3 Reasons for missing the 6 minute walk test at month 6 included 9 of 14 with poor compliance missed visit 8 of 9 of these from a single site and 1 of 9 had a prior ICVA with MRS score of 2 2 were too sick 1 had no form available 1 had been transplanted within the 14 day visit window and 1 had refused Th
16. Indicator will flash RED and the message on the controller will display Critical Battery 1 or Critical Battery 2 If this occurs there are only a few minutes of power remaining before the pump stops therefore the batteries must be replaced immediately CAUTION ALWAYS recharge fully depleted batteries within 24 hours to avoid permanent battery damage 12 1 Changing a Battery 1 Make sure there is a fully charged battery available to replace the used or depleted battery 2 Disconnect the depleted battery by turning the connector sleeve counterclockwise until it stops follow arrow Pull the connector straight out from the controller 4 Grasp the cable of the fully charged battery near the connector leaving the connector free to rotate 5 Line up the solid white arrow on the connector with the white dot on the controller Figure 51A 52 6 HeartWare Ventricular Assist System Instructions for Use Figure 51 Connecting power to controller Gently push the cable into the controller DO NOT twist the connector but allow it to naturally lock in place A successful connection will result in an audible click NOTE When pushing the connector onto the controller the white arrow will shift slightly Correct locking position white arrow aligned with white dot on controller Figure 51B 7 Confirm that the battery cables are properly locked on the controller by gently pulling the cable near the controll
17. Instructions for Use APPENDIX C PRODUCT SPECIFICATIONS 160g 50cc Titanium Titanium Nitride amp PEEK Gel impregnated polyester graft 60cm 10mm Gelatin sealed polyester PEEK 119cm 4 2mm PTFE coated MP35N DFT wire in a silicone inner sleeve with a polyurethane outer sleeve along with a polyester sleeve Titanium polyester 0 5kg 13 4x10 5x5 1 cm Plastic Absylux Main screen battery Levels 1 amp 2 Status and 3 alarm priorities Alarm Mute Scroll Arrow Li lon rechargeable 0 5 kg 9 9x8 9x4 5 cm Battery level LED 14 8 V 51 8 Wh 4 batteries 5 hours fully depleted 1 3kg 28 6x 13 4 x 10 2 cm Local mains AC 110 240 VAC 50 60 Hz 100 240 V 50 60 Hz 75 VA 17 V 4 A output 0 7 kg 11 8x7 5 100 250 V 50 60 Hz 140 VA 15 V 4 0 A output 88 HeartWare Ventricular Assist System Instructions for Use DC Adapter Weight 0 7 kg Dimensions 15x8 3x5 1 cm Electrical Ratings 11 5 15 6 VDC 30 70 W Input 15 V 2 A output Monitor Type Notebook with touch screen Input Operating System QNX Weight 2 5 Kg Dimensions 29 9 x 23 5 x 4 5 cm Electrical Ratings 19 V 3 2 A input Monitor AC Adapter Weight 0 7 kg Dimensions 16 6 x 9 6 x 5 6 cm Electrical Ratings 100 250 V 50 60 Hz 215 VA 19 V 4 7 A output Software Parameters Ranges amp Factory Default Settings Factory Default Pump Speed 1 800 to 4 000 RPM 20 RPM 2 500 RPM Notes All dimensions are given as length x width x height
18. Mhz outside ISM IEC 61000 4 6 bands 10 Vrms d 1 24 P within ISM bands i d 1 2 P 80 MHz to 800 MHz O REIS 10 Vrms 150 kHz to 80 Mhz inside ISM bands d 2 3VP 800 MHz to 2 5 GHz 61000 4 3 10 Vrms 80 MHz to Where P is the maximum output power rating of the 2 5 GHz transmitter in Watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m i Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects amp people 93 HeartWare Ventricular Assist System Instructions for Use The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas Fo
19. NOT use a damaged battery Battery function is unknown if the battery is damaged CAUTION DO NOT short circuit the external contacts on a battery since this may result in battery damage CAUTION DO NOT touch the fluid if a battery pack is leaking fluid Dispose of a leaking battery pack In case of eye contact with fluid DO NOT rub eyes Immediately flush eyes thoroughly with water for at least 15 minutes lifting upper and lower lids until no evidence of the fluid remains Seek medical attention CAUTION DO NOT expose batteries to excessive shock or vibration since this may affect battery operation CAUTION DO NOT dispose of a battery in fire or water Dispose of batteries according to federal state and local regulations CAUTION ONLY use the HeartWare Battery Charger to charge HeartWare Batteries Other battery chargers will not charge the batteries and may damage them CAUTION ALWAYS wait until the Ready light turns on to disconnect the battery from the battery charger If this is not followed over consecutive charging cycles the Battery Capacity Display will not function properly and may convey misleading battery capacity CAUTION DO NOT use HeartWare equipment in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide CAUTION A backup controller should always be available and programmed identically to the primary controller CAUTION DO NOT exert excessive tension or force on t
20. Response and to enter the HVAD Pump serial number Fixed mode manual entry of pump speed is the only mode currently available and therefore this button is disabled Patient VAD Controller Monitor L min 2860 A HW1400 RPM po Mode Fixed 4 2 de eal Watts dl Speed Control ieee 1 GEA 2 CH HeartWare Figure 30 VAD tab Press the VAD ID button to enter the HVAD Pump serial number from the Implant Kit package After pressing the VAD ID button a dialog box is displayed Figure 31 and the serial number is entered by using the keypad to enter letters and numbers The first two letters of the VAD ID are fixed with the letters HW After the information is entered press the Change button If an incorrect number is entered press Cancel and start again 40 HeartWare Ventricular Assist System Instructions for Use Figure 31 VAD ID dialog box The Suction Response button includes two options for suction detection e Suction Response Off This is the default setting e Suction Response on with Alarm An alarm will sound if a suction event is detected See section 9 3 2 Ventricular Suction Detection Alarm for more information on suction detection When the pump speed is changed by accessing the Speed Control tab the dialog box reminds users that this will disable the suction detection alarm Figure 32 3 5 MA 2500 Plow Lenin d
21. Sintered Pumps in CAP Cohort INTERMACS Category Sintered N 60 Non Sintered N 132 po y np ischemiceva 2 33 01 2 at a3 4 Hemorrhagiccva 4 67 2 2 76 3 9 mA la faz oo ala aal a A multivariate analysis was performed to identify the most significant factors associated with at least one stroke ICVA and HCVA event and a stroke mitigation strategy was developed To mitigate the risk of stroke with HVAD pumps clinicians should adhere to the following patient management guidelines Maintain MAP at lt 85 mm Hg as tolerated The HVAD pump is sensitive to both preload and afterload Ramp speed and flows more slowly during the first few weeks e g 30 days post implant to avoid excessive hemodynamic forces that may damage fragile blood vessels that have undergone remodeling secondary to the lower pressures and reduced flow associated with medically treated heart failure There is no apparent need to exceed a cardiac index of 2 6 L min m2 until patients have fully recovered from the implant surgery and physical performance improves A cardiac index of 2 6 L min m2 is the lower limit of normal for a healthy adult Maintain anticoagulation within the recommended INR range of 2 0 3 0 Check for ASA resistance with a reliable test e g VerifyNow and adjust ASA mono therapy accordingly or consider combination therapy such as ASA 81 mg plus Aggrenox ASA plus extended release dipyridamole
22. an impeller which spins blood to generate up to 10 L min of flow There are two motors in the pump housing with one motor providing redundancy A short integrated inflow cannula is inserted into the left ventricle and the outflow graft connects the HVAD Pump to the aorta A sewing ring attaches to the myocardium and allows for pump orientation adjustments intraoperatively The device size and short inflow cannula allow for pericardial placement which eliminates the need for abdominal surgery and device pockets Figure 4 Figure 4 HVAD Pump and left ventricular LV cannulation 24 HeartWare Ventricular Assist System Instructions for Use 8 2 HeartWare Controller The controller Figure 5 is a microprocessor unit that controls and manages HeartWare System operation It sends power and operating signals to the blood pump and collects information from the pump The percutaneous driveline is connected to the controller which must always be connected to two power sources an AC adapter or DC adapter and or rechargeable batteries The controller s internal non replaceable rechargeable battery is used to power an audible No Power alarm when both power sources are disconnected The controller interfaces with the monitor through a data port Figure 5 Controller 1 Monitor Connection 2 Power Connection 3 Driveline Connection 4 Power Connection CAUTION ONLY use HeartWare Controllers on one patient to avoid risks asso
23. atvcalee ate gal oeet nine ees a N 75 17 2 MYOCARDIAL RECOVERY PUMP EXCHANGE ina it its 76 13 0 PATIENT MANAGEMENT ias AA AAA 76 18 1 POSTOPERATIVENIAN AGE MENTOR oi 76 18 2 JEMERGENCUIVIAN A GEMENT cotas adidas 77 1853 AN EOA CUA Ntra tere trola 77 16 4 INFECTION CONTROL GUIDELINES manere n A 78 18 5 DRVEUNE CAR N N 78 18 6 JARRE THIMIAS dde iia 79 18 7 RIGGAT HEART FAILURE arta ns 79 18 8 BLOOD PRESSURE MAINTENANCE susana 80 18 9 PHYSICAL RE HABIEI TATION o aio N 80 LSO PATIENT EDUCATION ariar E E S 80 St EXTERNAL ACCESSORN ES las 80 a O O O A 80 IBA feg Ware SHOW CE DO E T E E A A A 81 18 12 RECOMMENDED EQUIPMENT FOR USE ATOMEsiain ia A A Ai 81 19 0 EQUIPMENT INSPECTION CLEANING AND MAINTENANCE ccsscssccsccscesccccecceccssescesees 82 OL GENERA GARE zerie adiciona 82 IZ CONTROL E R ere ae en 82 193 BACTERIA A N 83 MA BATTER CHARGE E E E E 83 19 5 HCARTWARF MONITOR aee T S 83 19 6 EXPECTED USEFUL LIFE OF HEARTWARE COMPONENTS it A da 84 19 7 PRODUCT DISPOSAL preine ninia 84 20 0 DEVICE TRACKING AND REPORTING REQUIREMENTS cssssccscssccsccsccscesccscesccccsccescssoncess 84 APPENDIX A QUICK REFERENCE GUIDE FOR ALARMS ssssssosssssessososessseseososososessososososeseseseseos 85 APPENDIX B SYSTEM COMPONENTS usina a a 87 APPENDIX C PRODUCT SPECIFICATIONG ssscsccccccccsccescnsnssnssanceccescaccescescnsnssnssencescescescsenans 88 APPENDIX D EMC MANUAL REQ
24. connected when the VAD is running 4 Grasp the Tyvek lid of the HVAD Pump implant kit package at the point indicated and peel back taking care not to contaminate the inner sterile tray 5 Pass the HVAD Pump tray and other components aseptically onto the sterile field Examine all components including the surgical tools for damage corrosion or any abnormalities that might affect the safety or functionality of the tools If any abnormalities are noted please use the appropriate backup supplies 6 Cover the HVAD Pump with a sterile towel With the driveline extended on the back table remove the Tyvek sleeve peel off by hand covering the polyester covered portion of the driveline see Figure 60 Wipe the driveline with a lap sponge moistened with antibiotic irrigation and discard the sponge 67 HeartWare Ventricular Assist System Instructions for Use 7 8 Figure 60 Tyvek sleeve covering polyester on driveline On the sterile field fill a basin with 2 liters of 5 dextrose Attach the sterile driveline extension cable to the HVAD Pump and pass the distal portion of the cable labeled Controller to the non sterile assistant WARNING ALWAYS check for an audible click when connecting the driveline to the controller or driveline extension cable Failure to ensure a secure connection may cause an electrical fault 10 11 12 13 14 Clamp the sterile portion of the extension cable to the
25. device Improper operation of the system and potential harm to the patient and to the user could result INTRODUCTION STERILE All HeartWare components used at implant including surgical tools are provided sterile The HeartWare Ventricular Assist System HeartWare System is designed to assist a weakened poorly functioning left ventricle The HeartWare System utilizes a centrifugal blood pump the HVAD Pump the pump which is implanted in the pericardial space with left ventricular apex to ascending aortic cannulation for left ventricular support Figure 1 The inflow conduit which is partially sintered is integrated with the pump and a 10mm gel impregnated outflow graft with a strain relief is attached to the pump A percutaneous driveline connects the pump to an external controller The controller powered by two batteries or by one battery and electricity from the wall or car outlet regulates pump function and monitors the system The monitor is used to display system performance and to change controller operating parameters A battery charger is also included All components of the HeartWare System are designed to be used only in conjunction with each other They are neither compatible nor intended to be used with other manufacturer s devices Figure 1 HeartWare Ventricular Assist System 1 Monitor 4 Controller 2 HVAD Pump 5 Battery 3 AC Adapter HeartWare Ventricular Assist System Instructions fo
26. fully charged battery to the controller NOTE Once powered the controller performs a self test and will display a temporary message regarding the status of the self test If the controller fails the self test a controller fault alarm message will appear In that case replace the controller with the second controller 6 Press Speed Control tab and reduce the set speed to 1800 RPM 65 HeartWare Ventricular Assist System Instructions for Use 7 Press Setup tab to display Patient VAD Controller and Monitor tabs see Section 10 4 2 Setup Tab 8 Press the Patient tab and enter the Patient ID and Implant Date 9 Ensure the Hematocrit setting is 30 10 Press VAD tab and enter HVAD pump serial number and verify that Suction Response is Off 11 Press Controller tab and enter controller date and time 12 Press the Alarm Settings tab to set the Low Flow Alarm limit and High Power Alarm limits Default settings are 1 L min for low flow and 16 watts for high power 13 Remove data cable 14 To prevent the controller alarm from sounding after the power is removed follow these instructions e Ifared alarm adapter is available Insert it into the blue connector on the controller e l fno alarm adapter is available Press and hold the Alarm Mute and Scroll Buttons on the controller until a beep is heard or for at least 5 seconds 15 Disconnect both power sources from controller 16 Set the backup co
27. implant test and prior to implantation The HVAD Pump must be completely submerged in fluid before being turned on WARNING DO NOT implant gel impregnated vascular prostheses in patients who exhibit sensitivity to polyester or materials of bovine origin as severe reactions may occur WARNING DO NOT allow the Gelweave prostheses non sterile foil pouch or outer tray to be introduced to the sterile field or the sterile field will be contaminated Only the innermost tray is sterile WARNING DO NOT preclot the outflow graft Preclotting may disrupt the gel matrix resulting in bleeding Gelweave prostheses are sealed grafts and must not be preclotted WARNING DO NOT implant the Gelweave prostheses more than one month after removal from the foil pouch This may disrupt the gel matrix resulting in bleeding WARNING DO NOT allow anyone but a surgeon physician s assistant or surgical assistant trained in the procedure to attach the outflow graft to the pump as a loose graft connection may lead to bleeding and or an air embolus WARNING ALWAYS rotate the strain relief so that the clamp screw is located on the inner side of the outflow conduit to avoid tissue irritation or damage WARNING DO NOT use excessive force when tightening the clamp screw because this could damage the graft clamp or graft clamp screw and a loose connection may result in bleeding and or an air embolus Replace components if required WARNING DO NOT over loosen
28. indicate proper connection Ensure that the power indicator on the power adapter cable turns green before plugging into the controller Figure 54 AC adapter Figure 55 Power cord connection The DC adapter Figure 56 plugs into the power port located in most cars When the DC adapter is properly connected to power a green indicator light will be displayed on the adapter Figure 56 DC adapter NOTE The DC adapter is for use in vehicles only and may not fit in some vehicles 14 1 Connecting the AC Adapter or DC Adapter to the Controller 1 Connect the AC adapter into a grounded electrical outlet or the DC adapter into a power port located in most cars WARNING DO NOT plug the AC adapter into an electrical outlet which is not properly grounded or you may receive a serious electrical shock 56 HeartWare Ventricular Assist System Instructions for Use 2 Disconnect the battery with the least remaining charge The corresponding battery indicator will turn off 3 Grasp the cable of the AC adapter or DC adapter near the connector leaving the connector free to rotate 4 Line up the solid white arrow on the connector with the white dot on the controller Figure 57 Figure 57 Correct adapter alignment Figure 58 Correct locking position 5 Gently push the cable into the controller DO NOT twist the connector but allow it to naturally lock in place A successful connection will result in an audible click Figu
29. or letters 38 HeartWare Ventricular Assist System Instructions for Use er SE ee Enter Patient ID Figure 28 Patient ID dialog box NOTE Patient ID must be entered for patient s alarms to be displayed in the monitor s alarm log Press the Implant Date button and enter the HVAD Pump implant date using the keypad Use the Enter button to confirm entry or the Cancel button to cancel entry Figure 29 VAD OFF 0 0 an 2010 L min November o A RPM 0 0 Watts HW1234567 POD 3 Se 21 08 52 HeartWare Figure 29 Implant Date Screen The hematocrit can be changed using the Hematocrit button refer to Figure 27 This method allows the clinician to manually input the patient s hematocrit using a measurement obtained from a blood sample The default hematocrit value is 30 10 4 2 1 1 Downloading Controller Log Files The Log Files button allows the clinician to obtain alarm and trend data from the controller and to transfer it from the patient s controller to a USB flash drive Process for downloading log files from the controller e Using the monitor data cable connect the blue data port on the controller to the monitor e Check that the data download icon in the lower left hand corner of the monitor is flashing grey The data download icon will become black when the download is complete It may take up 10 minutes for all the data to transfer from the controller to th
30. replaced Figure 49 Battery Battery Buttons and Indicators Pressing the TEST BUTTON will light up the Battery Capacity Display The BATTERY CAPACITY DISPLAY will tell you how much power remains in the battery The Battery Capacity Display on the battery is similar to the Battery Indicator on the controller see Section 11 0 Using the HeartWare Controller except that only green lights are used on the battery For example at 25 49 capacity 2 green lights will be displayed on the battery while 2 yellow lights will be displayed on the controller see chart below 51 HeartWare Ventricular Assist System Instructions for Use Battery Capacity Display on Battery Indicator on BATTERY CONTROLLER Battery Capacity NOTE When one battery is depleted to lt 25 the controller will automatically switch to the other battery When this happens an intermittent beep will sound the Alarm Indicator on the controller will be yellow and a message will be displayed to replace the depleted battery Figure 50 mn po Ay larrilarraoas RA 1tPPIaCe Da y E pitas ple Figure 50 Replace depleted battery message on controller If the battery is NOT changed within 5 minutes the alarm volume will escalate until the battery is exchanged with a fully charged battery When a depleted battery is not exchanged and there are only a few minutes of battery time remaining in both batteries a high priority alarm will sound the Alarm
31. sure to wear a cap mask and sterile gloves CAUTION AVOID the use of prophylactic topical antibiotic ointments such as silver sulfadiazine betadine or polymyxin neomycin bacitracin on the tissue around the driveline exit site as these ointments can injure the tissue 6 Immobilize the percutaneous lead with occlusive dressing and if necessary a Hollister clip Montgomery strap or a custom made percutaneous lead immobilization binder or belt Keep the extra external length of the driveline under a binder or clothing 7 Complicated non routine driveline dressing changes that involve exit site infections may require assistance supervision from a health care professional 8 For wounds incisions other than the driveline exit site that require dressing changes and or other care the ability of the patient and caregiver to provide that care will be evaluated by the implanting center Treatment plans will be dependent upon this evaluation 18 6 Arrhythmias The HVAD Pump functions most effectively when adequate and stable amounts of preload are available A stable supraventricular rhythm helps to optimize right heart performance and provide the HVAD Pump with preload Many heart failure patients will have permanent pacemakers and internal defibrillators in place by the time an LVAD is implanted These devices are often needed in the early postoperative period 18 7 Right Heart Failure Right heart failure is common in patients recei
32. the adverse events are listed in alphabetical order Death Air embolism Aortic insufficiency Bleeding perioperative or late Cardiac arrhythmias Death Device malfunction Device thrombosis Driveline infection Driveline perforation Driveline wire damage Erosions and other tissue damage Gl bleeding AV malformations Hemolysis Hepatic dysfunction Hypertension Interference with from other devices Local infection Multi organ failure Myocardial infarction Neurologic dysfunction Organ damage during driveline tunneling Pericardial effusion tamponade Peripheral thromboembolism Platelet dysfunction Psychiatric episodes Renal dysfunction Re operation Respiratory dysfunction Right ventricular failure Sensitivity to aspirin Sepsis Stroke Worsening heart failure Wound dehiscence HeartWare Ventricular Assist System Instructions for Use 7 0 CLINICAL TRIAL RESULTS 7 1 7 2 7 3 Pivotal Clinical Study Design This was a multi center prospective contemporaneous control trial The trial was non randomized and open label Enrollment in the study is complete subjects have all reached the primary endpoint as described and specified in the protocol but follow up of subjects is ongoing Subjects were consented for participation and then assessed against the inclusion and exclusion criteria for participation in the study and implantation of the HVAD Pump After the surgical recovery period patients
33. the cause of any alarm Silencing an alarm does not resolve the alarm condition WARNING DO NOT grasp the driveline cable as this may damage the driveline To remove the driveline from the controller first pull back the driveline cover then grasp and pull the driveline connector WARNING DO NOT disconnect the driveline from the controller or the pump will stop If this happens reconnect the driveline to the controller as soon as possible to restart the pump WARNING DO NOT operate the controller in temperatures less than 20 C 4 F or greater than 50 C 122 F or the controller may fail WARNING DO NOT attach the alarm adapter to a controller connected to the running pump The alarm adapter silences the No Power alarm and should only be attached to a controller that has failed or malfunctioned and is no longer connected to a pump WARNING ALWAYS keep a spare controller and fully charged spare batteries available at all times in case of an emergency WARNING DO NOT plug the AC adapter into an electrical outlet which is not properly grounded or you may receive a serious electrical shock WARNING ALWAYS check the controller display for any information regarding an alarm when using loud machinery or in the vicinity of loud noises as the alarms may not be audible WARNING ALWAYS replace a controller with a blank display or no audible alarms This condition is predictive of a controller failure WARNING ALWAYS switch to
34. the outflow graft clamp CAUTION Always use the smallest possible needle for de airing 19 gauge is normally sufficient Hypodermic needles have a cutting point which may result in blood leakage and may require repair by suturing 5 Start HVAD Pump at 1800 RPM by pressing the blue button labeled START on the monitor 6 With the HVAD Pump at 1800 RPM use TEE to assess air in the left ventricle and aorta WARNING ALWAYS remove all air from the HVAD Pump and its conduits to reduce risk of air embolus WARNING DO NOT de air the HVAD Pump when there is inadequate blood volume in the HVAD Pump or leaks in the inflow outflow connections as air may enter the HVAD Pump and outflow graft resulting in a delay in de airing and possible air embolism 74 HeartWare Ventricular Assist System Instructions for Use CAUTION DO NOT rely on HVAD Pump flow estimation during the de airing procedure Flow estimation may not be accurate 7 After all air is removed remove the 19 gauge needle and oversew the needle hole with pledgeted sutures Release the outflow graft cross clamp Gradually increase HVAD Pump speed to achieve the desired flow and wean from cardiopulmonary bypass as tolerated NOTE Increase HVAD Pump speed in increments of 100 RPM with a 20 second interval between speed changes to gradually increase flow and to help prevent ventricular collapse 16 9 Programming the Backup Controll
35. the speed will immediately disable the ventricular suction detection alarm An Sx Off will be displayed on the monitor screen below the Fixed Mode display The clinician will have to reactivate the alarm after adjusting the speed CAUTION Manual changes to the speed will immediately disable the ventricular suction detection alarm An Sx Off will be displayed on the monitor screen below the Fixed mode display The ventricular suction detection alarm will have to be re activated CAUTION DO NOT enable the ventricular suction detection alarm while the patient is in a suction condition To optimize operation of the suction detection the patient should be hemodynamically stable prior to enabling the ventricular suction detection alarm The ventricular suction detection function will temporarily deactivate if e The estimated flow value becomes invalid Once the flow estimation is within valid range the ventricular suction detection will resume e The baseline flow value is less than 1 8 L min the algorithm loses sensitivity if the baseline and therefore the suction detection level gets too low Once the baseline value is above 1 8 L min then the ventricular suction detection will resume e The clinician changes the hematocrit input the algorithm recognizes that a change in the fluid viscosity will cause a change in the estimated flow The ventricular suction detection reactivates once a new baseline is establis
36. values at baseline were in general unremarkable except for an elevated BUN 26 14 mg dL and a depressed hematocrit 34 5 8 Eighty percent of subjects in the HeartWare System treatment group were on inotropic therapy at baseline Some 23 were on more than one inotrope IABP therapy at baseline was reported for 25 of subjects and 85 presented with an AICD Subjects received typical medications for congestive heart failure with diuretics 82 most common Comparison of Selected Baseline Characteristics between Treatment and Control Groups The mean age of implant recipients in the HeartWare System group was 53 3 range 22 70 and for the control 52 2 Other parameters available to compare included gender BSA BUN right atrial pressure and creatinine In all cases the values for both the HeartWare treatment and control groups were not statistically significantly different Table 1 Table 1 Select Baseline Characteristics for HeartWare and INTERMACS Groups HeartWare System INTERMACS Characteristics N 140 N 499 Age years 53 3 10 3 52 2 12 2 Female Gender n 39 28 120 24 BUN mg deciliter 25 31 13 5 28 9 20 9 Right atrial pressure mmHg 10 8 3 3 11 5 5 0 Serum creatinine mg dL 1 3 0 4 1 40 6 10 7 4 HeartWare Ventricular Assist System Instructions for Use Safety and Effectiveness Results EFFECTIVENESS RESULTS Primary Endpoint The analysis of the primary endpoint demonstr
37. 15 2 Medium Alarms A medium alarm starts at a low volume and gets louder over the next minute unless the Alarm Mute Button is pressed Pressing the Alarm Mute Button will silence medium and low level alarms for 5 minutes or until an additional alarm occurs If the Alarm Mute button is not pressed after 5 minutes the alarm volume is elevated to the level used in high alarms A medium alarm is indicated by a flashing YELLOW Alarm Indicator and the text message tells the patient to call medical personnel for instructions to resolve the alarm condition For information on how to mute an alarm see section 15 5 How to Silence Mute an Alarm 59 HeartWare Ventricular Assist System Instructions for Use Medium Alarms Message on Message Alarm on Indicator Controller Meaning Alarm Sound Controller A line 1 line 2 High Watts Electrical A change in the Fault status of the e Gradual increase in HeartWare volume over the first Low Flow System is detected minute if alarm not muted e Alarm gets louder after 5 Controller Call Controller minutes if alarm not Fault malfunction muted Flashing 1 Controller YELLOW malfunction e Able to mute alarm for 5 minutes or 1 hour e Electrical Fault audio detection low can be permanently Entro l Call flow alarms disabled Fault ALARMS disabled e Controller Fault audio OFF High power and can be permanently VAD disabled Suction disconnected alarms may be disa
38. BACKGROUND soea a E E E A 27 diz BLOOD FLOW CHARACTERISTIC a 28 9 3 PHYSIOLOGICAL CONTROL ALGORITHMS ccccesssseesccceeeeeessssnseecececsessssenseeceeecessussesseeeneeeessssnseseenessesas 28 9 3 1 FOWE SIMAO A A wee ROI 29 9 3 2 Ventricular SUCTION DETCCTION AO AA AAA 29 9 4 HVAD PUMP OPERATING GUIDELINES ocre iaa A aS 31 10 0 USING THE HEARTWARE MONITOR ssccsssccssccssccssccssccssccnsscesscsscssecsscesssessssesssesssesses 33 OTE CEINIGALVFIOME SCREEN us a e dd ds os 34 102 ALARM SCREEN ninas 35 TOS TREND SCREEN osa dada 36 104 SYSTEM SCREEN toa 36 TOAD Speer CONO ADN o 37 HeartWare Ventricular Assist System Instructions for Use LOZ SUD TIA o ade 38 1043 AQT SCTHNOS TODA E tad 44 TOD A O A O A 47 11 0 USING THE HEARTWARE CONTROLLER ssccsscosscssccscccsscnsccsscnsccsccesscesccsscesscescesscescosces 47 TET CONTROLLER CONNECTOR LAO UT dell assests ies 47 11 2 CONTROLLER DISPLAY AND OPERATION puristas ameotantsbaccateaesetaeies 48 LL HOW TO CHANGE THE CONTROLLER cours aa 49 12 0 USING THE HEARTWARE BATTERIES consi anar 51 121 CHANGING A BATTERY 2 1 00 c02 5zesaneteetundsadia ane loci cslenl 52 1272 CARE OF BATTER EStdt eects 53 13 0 USING THE HEARTWARE BATTERY CHARGER ssseessecsecessecsecscsecseosesecsecsececsecsecseceesecsesee 54 13 1 CONNECTING THE BATIERY TO THE BATTERY CHARGER cuicos ide 55 13 2 DISCONNECTING THE BATTERY FROM THE BATTERY CHARGER sc0scsecsecsa
39. Operation at temperatures below 0 C will temporarily reduce battery capacity but the battery will operate Storage 20 C to 25 C 4 F to 77 F Long term storage outside of this range may permanently reduce the battery capacity Best condition for storage is at room temperature CAUTION ALWAYS keep batteries away from children Children may be harmed by damaged batteries or components CAUTION DO NOT disassemble crush or puncture a battery CAUTION DO NOT use a damaged battery Battery function is unknown if the battery is damaged CAUTION DO NOT short circuit the external contacts on a battery since this may result in battery damage CAUTION DO NOT touch the fluid if a battery pack is leaking fluid Dispose of a leaking battery pack In case of eye contact with fluid DO NOT rub eyes Immediately flush eyes thoroughly with water for at least 15 minutes lifting upper and lower lids until no evidence of the fluid remains Seek medical attention CAUTION DO NOT expose batteries to excessive shock or vibration since this may affect battery operation CAUTION DO NOT dispose of a battery in fire or water Dispose of batteries according to federal state and local regulations 13 0 USING THE HEARTWARE BATTERY CHARGER The battery charger Figure 52 can charge up to 4 batteries at a time It takes approximately 4 to 5 hours to fully charge a depleted battery The battery charger must be plugged into a properly ground
40. UIREMENTS GUIDANCE DOCUMEENT ccscsscsscsccscsscscescsces 91 APPENDIX E SYMBOL DEFINITIONS cnica is 95 HeartWare Ventricular Assist System Instructions for Use HeartWare Ventricular Assist System Instructions for Use FOREWORD 1 0 The HeartWare Ventricular Assist System is indicated for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use Clinical users include physicians registered nurses perfusionists and biomedical engineers Implant of the device must be performed by a qualified cardiac surgeon trained by HeartWare authorized personnel Clinical users of the HeartWare System should attend HeartWare clinical operator training should have a working knowledge of the principles of left ventricular assist devices LVADs and should be aware of the physical and psychological needs of patients undergoing LVAD support Patients and caregivers should complete a user training program and demonstrate their ability to use the system Clinicians should read the entire Instructions for Use before system operation This manual may serve as a reference for detailed information including specific information on device function system setup implant and maintenance This manual is not intended to replace comprehensive educational programs or to supersede acquired knowledge or proper medical judgment WARNING Carefully read this entire manual prior to implanting or operating the
41. VAD Connect alarm may be other alarms or symptoms replace audio and controler ALARMS disabled controller and assess in emergent Controller Fault OFF e High Power alarm may be visit Fault audio disabled e Download email patient log files can be from original alarming controller permanently and new controller disabled e Contact HeartWare Clinical Support y dea an e HVAD Pump Watts have e Confirm correct settings for High on the exceeded High Power alarm Power alarm and pump speed cantccllarts threshold e Consider checking blood dear eatalice e Alarm threshold set too coagulation labs ela l close to average power e Assess patient for hemolysis alan High Watts Call Thrombus or other Download email patient logs files messages materials e g tissue e Check for aortic insufficiency fragments in the device thrombus etc e High RPM e Contact HeartWare Clinical Support e High flow e VAD electrical fault 85 HeartWare Ventricular Assist System Instructions for Use Flashing Yellow A Electrical Fault Fault in continuity of pump to controller electrical connections Partial driveline fracture Connector malfunction Controller component failure VAD malfunction Average flow below Low Flow alarm threshold Alarm threshold set too close to average flow Suction RPM too high or too low Poor VAD filling right ventricular failure hypovolemia tamponade arrhythmias inflow cannula obstruction e
42. akage e VAD electrical failure e Controller failure e Exchange controller e VAD failure e Contact HeartWare Clinical Support e Thrombus or other e Download email patient log files materials e g tissue fragments in the device Controller Change e Controller component failed Exchange controller e Contact HeartWare Clinical Support VAD Change Stopped Controller Failed Controller e Replace critical battery with fully charged battery or AC or DC adapter e Change controller if new power sources do not correct alarm Critical Replace e Limited battery 1 or battery Battery 1 Battery 1 2 time remamng e Battery malfunction Replace Battery 2 Critical Battery 2 e Confirm frequency and duration of Flashing Intermittent controller component alarm concurrent alarms and Yellow beep malfunction but pump still pump il w spesd power A e Gradual Controller Call working e Assess patient for complaints of increase in Fault E shortness of breath chest pain alarm volume palpitations dizziness etc over time if e Isolated alarm monitored with not muted download at next visit e Able to mute e Controller component e Multiple alarms within 24 hours alarm lora malfunction without other issues should be minutes or 1 e Suction Detection disabled assessed at non emergent visit nour l e Low Flow alarm disabled e Multiple alarms within 1 hour with j Electrical Fault Call e
43. aration distance according to frequency of transmitter m output power of transmitter 150kHz to 80MHz 150kHz to 80MHz 80MHz to 800MHz to 2 5GHz 800MHz W tside ISM band ithin ISM band 9 3 outside ands within ands ESTOP D d 12 P d 12 P For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 94 APPENDIX E SYMBOL DEFINITIONS Attention consult ac
44. art function and left ventricular afterload 31 HeartWare Ventricular Assist System Instructions for Use 8 6 E L min Flow Pulsatility gt 4 Waveform Trough gt e 0 Figure 14 HVAD Pump flow waveform The flow waveform trough is the minimum value of the HVAD Pump flow waveform The trough value should be gt 2 L min and there should be gt 2 L min of pulsatility An example of a flow wave form with a trough of gt 2 l min and pulsatility of gt 2 L min is shown below SUA 5 1 Fay L min 2800 A Flow L min RPM Time s 4 0 Watts d L VAD STOP ES Set RPM 2800 a ON Speed Alarm Setup Control Settings Ay HW1234567 POD 9 22 56 55 1 di TU 2 HeartWare Figure 15 HeartWare Monitor screen showing HVAD Pump flow waveform 32 HeartWare Ventricular Assist System Instructions for Use 10 0 USING THE HEARTWARE MONITOR To turn the monitor ON press and hold the power button until the monitor software starts up The power button is located on the top of the monitor Figure 16 Figure 16 Monitor Power Button 1 The monitor is designed to provide a user friendly way to monitor and control the HeartWare System The monitor e Displays pump information e Allows users to adjust pump parameters e Monitors and reports system errors and alarm conditions CAUTION ALWAYS fully charge the monitor s internal bat
45. ated HVAD non inferiority to the control group Table 2 The difference in success rates between the HVAD group and controls was less than the 15 non inferiority margin p lt 0 0001 The 95 one sided UCL on the difference in success rates was 4 5 for the Safety SAF population analysis and 0 9 for the Per Protocol PP population analysis The pre specified primary endpoint was achieved Table 2 Success Rates and Inference on non Inferiority Implanted Successes L O Safety Cohort Per Protocol Cohort lt 0 0001 P value From significance test of non inferiority UCL 95 one sided upper confidence limit on the difference in success rates Note The table accounts for 497 of the 499 INTERMACS patients the remaining 2 patients who withdrew consent before 180 days have a missing success failure outcome lt 0 0001 Competing Outcomes A competing risks analysis was performed Figure 2 estimating the time related probability of experiencing each of the component events These data are calculated from all events occurring during the study duration including deaths transplants and exchanges occurring after 180 days but ending with last patient last visit 11 HeartWare Ventricular Assist System Instructions for Use Figure 2 Competing Risk Outcomes HVAD Safety Population HVAD patients Safety Population N 140 1 90 7 Transplant or Alive 1 0 original device in place 0 9 F Don i E
46. atient as this may affect HeartWare System operation WARNING AVOID therapeutic levels of ultrasound energy as the device may inadvertently concentrate the ultrasound field and cause harm WARNING AVOID therapeutic ionizing radiation since it may damage the device This damage may not be immediately detectable WARNING DO NOT use any components other than those supplied by HeartWare with the HeartWare System as this may affect HeartWare System operation WARNING DO NOT drop the controller or other equipment Dropping the controller could cause sudden stoppage of the pump Dropped equipment should be reported to HeartWare and inspected WARNING Damaged equipment should be reported to HeartWare and inspected WARNING NEVER clean the battery charger with the power on as this may lead to an electrical shock WARNING NEVER clean the monitor with the power on as this may lead to an electrical shock DO NOT use alcohol or detergent on the monitor display Gently wipe the display with a soft lint free cloth HeartWare Ventricular Assist System Instructions for Use 5 0 53 WARNING DO NOT disconnect the driveline or power sources from the controller while cleaning it or the pump will stop If this happens reconnect the driveline to the controller as soon as possible to restart the pump PRECAUTIONS 1 CAUTION Safety and effectiveness in persons less than 18 years of age and in persons with a BSA of less than 1 5 m h
47. ave not been established 2 CAUTION The HeartWare Ventricular Assist System has had limited use in patients with artificial mitral or aortic valves and therefore the risks are currently unknown Caution should be used in selecting patients with artificial mitral or aortic valves for HeartWare System therapy 3 CAUTION ONLY use HeartWare Controllers on one patient to avoid risks associated with an inadvertent mismatch of controller pump speed settings 4 CAUTION Manual changes to the speed will immediately disable the ventricular suction detection alarm An Sx Off will be displayed on the monitor screen below the Fixed mode display The ventricular suction detection alarm will have to be re activated 5 CAUTION DO NOT enable the ventricular suction detection alarm while the patient is in a suction condition To optimize operation of the suction detection the patient should be hemodynamically stable prior to enabling the ventricular suction detection alarm 6 CAUTION ALWAYS fully charge the monitor s internal battery prior to patient use 7 CAUTION DO NOT allow patients to touch the monitor as this may lead to the entering of unwanted HeartWare System parameters 8 CAUTION DO NOT use the Set Defaults button on the monitor when a controller is connected to a patient Pressing it will erase all patient VAD parameter information from the controller 9 CAUTION ALWAYS recharge fully depleted batteries within 24 ho
48. bled The following are Medium Priority Alarms High Watts This alarm warns of a high power condition in running the HVAD Pump The alarm is triggered when the Watts exceed the High Power Alarm threshold see section 10 4 3 This may occur due to thrombus or other materials e g tissue fragments in the device Electrical Fault A fault in the continuity of the pump to controller electrical connection triggers this alarm The fault could be in the HVAD Pump motor driveline and connector or within the controller The audio portion of this alarm can be permanently disabled via the monitor see section 10 4 3 When this alarm condition occurs the HVAD Pump will be running on a single stator and will consume slightly more power Low Flow The low flow alarm is triggered if average flow drops below the Low Flow Alarm threshold see section 10 4 3 Suction The ventricular suction detection alarm is triggered if the suction algorithm has identified a ventricular suction condition This may self clear if the suction is transient 60 HeartWare Ventricular Assist System Instructions for Use Controller Fault The controller contains two microprocessors one which controls pump function PMC and a second which controls user interface functions UIC such as controller display and buttons The controller fault alarm indicates a possible controller malfunction may have occurred but during this fault the UIC processor still receives a h
49. ch to the backup controller if there is a Controller Failed alarm since the HVAD Pump may not be running Critical Battery Displayed when there are a few minutes of battery time remaining to power the HVAD Pump or when the battery has malfunctioned Replace battery 1 or 2 with a fully charged battery or use the AC adapter or DC adapter If the controller has lost communication with a battery and the other power port is connected to either a battery with a remaining capacity of 25 or greater or a valid power adapter the controller shall generate a Power Disconnect alarm associated with the non communicating battery This alarm condition will clear or activate a different alarm if any of the following conditions occur 1 Communication with battery is re established alarm will clear 2 The remaining capacity of other battery drops below 25 critical battery alarm will be triggered When the controller has lost communication with a battery and the other power connector is NOT connected to a valid power supply or is connected to a battery with a remaining capacity of less than 25 the controller will generate a Critical Battery alarm This alarm condition will clear when any of the following occur 1 Communication with battery is re established 2 The non communicating battery is disconnected 3 The other power source is switched to a valid power adapter or to a battery having a remaining capacity of 25 or greater
50. ciated with an inadvertent mismatch of controller pump speed settings 8 3 HeartWare Monitor The monitor Figure 6 is a touch screen tablet that uses proprietary software to display system performance and to permit adjustment of selected controller parameters When connected to a controller the monitor receives continuous data from the controller and displays real time and historical pump information The monitor also displays alarm conditions Figure 6 Monitor 1 Power Cord 2 Monitor Controller Connection 8 4 HeartWare Controller Power Sources The controller requires two power sources for safe operation either two batteries or one battery Figure 7 and an AC adapter Figure 8 or DC adapter Figure 9 While active patients will typically use 25 HeartWare Ventricular Assist System Instructions for Use two batteries While relaxing or sleeping patients should use power from an electrical outlet AC adapter because it provides power for an unlimited period of time The batteries should be exchanged when their charge falls below 25 capacity Spare fully charged batteries should always be available Figure 7 Battery Figure 8 AC adapter Figure 9 DC adapter WARNING NEVER disconnect both power sources batteries and AC or DC adapter at the same time since this will stop the pump At least one power source must be connected at all times 8 5 HeartWare Battery Charge
51. companying documents Follow operating instructions Batch code Catalog number Serial number Keep dry no water ingress protection Protected against vertically falling water drops Protected against dripping water Protected against water jets Protected against the effects of water Defibrillation proof type CF applied part LoT 3 Temperature range Humidity range Atmospheric pressure range aas 95 HeartWare Ventricular Assist System Instructions for Use Date of manufacture Manufacturer Sterilized with ethylene oxide gas Non sterile Single use only do not reuse Do not use if damaged Properly dispose battery Use by YYYY MM DD or YYYY MM Direct current power connection Monitor connection Pump connection Input power required Output power delivered UL Classification Mark With respect to electric shock fire and mechanical hazards only in accordance with UL60601 1 IEC60601 1 CAN CSA C22 2 No 601 1 HeartWare Ventricular Assist System Instructions for Use 41CP11 34 50 2 41 CP11 34 SD 2 pin settings CE Mark Diameter The UL mark product safety certification Latex free Usable length Prescription only symbol Y Non pyrogenic HeartWare HVAD and the HeartWare Logo are registered trademarks of HeartWare Inc 96 HeartWare Customer Service Direct Dial 305 364 2500 or 877 367 4823 Fax 305 818 4118 E mail cs hear
52. connections are identical and are used to connect to any of the power sources batteries AC adapter or DC adapter The controller should always be connected to two power sources for safety If only connected to one power source the controller will function but will sound an alarm after 20 seconds 47 HeartWare Ventricular Assist System Instructions for Use Figure 43 Controller 1 Monitor Connection 2 Power Connection 3 Driveline Connection 4 Power Connection The driveline is connected to the silver connector To connect the driveline to the controller align the red markings on both connections and push together Figure 44 The driveline cover should completely cover the controller s silver driveline connector to protect it and keep it clean To disconnect the driveline pull the driveline cover away from the silver controller connector then pull the driveline connector from the silver controller connector Figure 44 Driveline connection to controller WARNING DO NOT grasp the driveline cable as this may damage the driveline To remove the driveline from the controller first pull back the driveline cover then grasp and pull the driveline connector WARNING DO NOT disconnect the driveline from the controller or the pump will stop If this happens reconnect the driveline to the controller as soon as possible to restart the pump The monitor cable attaches to the blue data port connector on the controller The monit
53. cular Assist System Instructions for Use CAUTION DO NOT use the Set Defaults button on the monitor when a controller is connected to a patient Pressing it will erase all patient VAD parameter information from the controller Disable VAD Stop Alarm The purpose of this feature is to allow programming of a controller when it is not connected to a pump or a motor fixture After applying power to the controller it will pause for ten seconds before detecting whether or not a pump is disconnected a VAD Stopped condition The Disable VAD Stop Alarm feature enables the user to send a command to the controller to tell it NOT to alarm when a pump is not attached This allows the input of patient and controller information via the monitor without an audible alarm This pending command will clear after 3 minutes Steps 1 2 Press Disable VAD Stop Alarm indicator on monitor Figure 35 Connect monitor to controller Power up controller with 2 power sources Enter patient and controller information via the monitor Disconnect monitor from controller Disable No Power alarm by pressing the Alarm Mute and Scroll buttons simultaneously for 5 seconds Disconnect power from controller The VAD Stop Alarm will be re armed automatically after 3 minutes as long as the monitor is not connected to a controller Figure 36 Patient Controller Monitor Controller Date Controller Time
54. ded to reduce the lag time in reaching full therapeutic benefit typically a 3 4 day lag Warfarin should be started within 4 days post op and titrated to maintain an INR of 2 0 to 3 0 Infection Control Guidelines For prevention of infection remove unnecessary IV lines and replace old IV lines before HVAD Pump implantation Administer antimicrobial prophylaxis based on the hospital s nosocomial and microbial sensitivity profile with sufficient coverage for staph aureus staph epidermidis and enterococcus Use pre operative scrub with antiseptic the night before and again the morning of the operation After HVAD Pump implantation continue systemic antimicrobials prophylaxis for 48 to 72 hours Remove mediastinal and pleural drains as soon as appropriate Early extubation removal of monitoring lines and patient ambulation are encouraged Rapid restoration of oral nutrition should be attempted using tube feeding if necessary Turning the patient side to side can start once the patient is clinically stable Physical therapy and active range of motion can begin on the first postoperative day The patient can be moved to a chair and can should use an exercise bicycle or treadmill as soon as possible Nursing measures to decrease infection include frequent hand washing and strict aseptic technique during contact with invasive lines and during HVAD Pump dressing changes Driveline Care To minimize the risk of infection driveline exit site dre
55. deral laws and regulations DO NOT incinerate discarded monitor batteries Medical Waste Disposal The explanted HVAD Pump and associated implantable components must be disposed of in compliance with all applicable local state and federal laws and regulations concerning medical waste Device Tracking and Reporting Requirements The HVAD Pump is considered a life sustaining medical device and must be tracked per US Food and Drug Administration FDA and other foreign regulatory agency regulations Compliance is mandatory Accordingly all device tracking paperwork must be completed and promptly returned to HeartWare In addition any device malfunctions must be reported to HeartWare by the implanting center 84 HeartWare Ventricular Assist System Instructions for Use APPENDIX A QUICK REFERENCE GUIDE FOR ALARMS Alarm LCD Display LCD Display Potential Causes Potential Action Alarm Tone Symbol line 1 y e Connect two new power sources e Replace controller e Contact HeartWare Clinical Support e Continuous loud e Unable to mute e No power to pump e Pump has stopped lt no lt no message gt message gt amp Flashing Loud Two e Driveline disconnected e Reconnect driveline Red toned alarm VAD Connec e Driveline fracture e Contact HeartWare Clinical Support unable to ME e Connector malfunction e Download email patient log files Stopped Driveline mute bre
56. e monitor e Press the Pump Icon to access the System Screen and enter the password e Press Setup tab 39 HeartWare Ventricular Assist System Instructions for Use e Press Patient tab e Wait until the data download icon stops flashing and turns black then disconnect the monitor data cable from the controller NOTE DO NOT disconnect the controller from the monitor when the data transfer icon is flashing as data is being transferred If the message Log Transfer Not Complete appears re connect the controller to the monitor to complete the data transfer e 5 seconds after disconnecting the data cable the Log Files button will appear Press this button and a list of the patient logs will be displayed e Place a HeartWare Monitor compatible USB memory stick into the USB port on the left side of the monitor e Select the logs to be saved Press the Save to USB button e Aconfirmation screen will appear to affirm selection If correct press YES button e A download complete message will appear when data download is complete Press OK e Remove the USB stick and email the three files data alarm and events 3 separate files to hvadlogs heartwareinc com NOTE The maximum storage for each controller is 3000 entries which equates to approximately 31 patient days A USB flash drive can be used intermittently to download data 10 4 2 2 VAD Tab The VAD tab Figure 30 is used to enable or disable the Suction
57. e to the controller Make sure to protect the driveline connector from contamination during this time Prior to removing the driveline cap put on clean dry gloves To remove the driveline cap unscrew the outer sleeve and pull back on the grooved part of the connector Next place the white rubber driveline cover over the driveline connector Verify that the connector is dry and clean before attaching to the controller If the driveline connector contains any fluid tissue or foreign material thoroughly clean it with isopropyl alcohol and dry it with a clean cloth Attach the driveline to the controller and slide the driveline cover forward to completely cover the controller s silver driveline connector After the driveline is connected to the controller the driveline cover is on and the pump has started immobilize the driveline at the exit site with retaining sutures WARNING DO NOT grasp the driveline and pull as this may damage the driveline To remove the driveline cap from the driveline unscrew the outer sleeve then pull back on the grooved part of the connector 16 8 De airing Procedure 1 2 Start ventilation Be sure that all IV catheters and pressure monitoring lines are closed to the atmosphere to reduce the possibility of air entering the heart and pump Reduce cardiopulmonary bypass flow to allow filling of the left ventricle and pump Place a sterile 19 gauge needle into the outflow graft between the HVAD Pump and
58. ean the monitor with the power on as this may lead to an electrical shock DO NOT use alcohol or detergent on the monitor display Gently wipe the display with a soft lint free cloth 83 HeartWare Ventricular Assist System Instructions for Use 19 6 Expected Useful Life of HeartWare Components The HeartWare System components were designed and tested to function without failing for the following periods e HVAD Pump at least two years e The controller is expected to function for at least one year e The battery charger is expected to function for at least one year e The battery is expected to function through a minimum of 500 charge and discharge cycles this will provide patient support for at least one year 19 7 Product Disposal 20 0 Specific product disposal considerations for certain HeartWare supplied equipment appears below Otherwise dispose of all expired or damaged equipment according to applicable local state and federal laws and regulations For additional product disposal support and information contact HeartWare Batteries HeartWare Li lon battery cells DO NOT contain lead Dispose of recycle HeartWare batteries in compliance with all applicable local state and federal laws and regulations DO NOT incinerate HeartWare Monitor The HeartWare Monitor contains a lithium battery replaceable Dispose of recycle the monitor s internal battery in compliance with all applicable local state and fe
59. eartbeat message from the PMC indicating the PMC is still functioning and controlling the pump The controller fault alarm will result in the word Call in the controller display notifying the patient to call the clinician The clinician should query the patient about the frequency and duration of alarm as well as any additional alarms and changes in pump flow speed or power The patient should also be asked about any clinical symptoms changes including dizziness shortness of breath angina and or palpitations Based on the patient s responses the following course of action should be taken e lf there was a single isolated controller fault alarm with no change in pump or clinical parameters instruct the patient to report any additional alarms that may occur Download the controller log files at the patient s next clinic visit and send to HeartWare for analysis e Instruct the patient to return to the center as soon as reasonable not emergently so the controller log file can be downloaded and sent to HeartWare for analysis if one of the following situations occurs o Ifa controller fault alarm has occurred and been resolved multiple times over a 24 hour period or o Ifa controller fault alarm has occurred in conjunction with other alarms even though it has not affected pump flow power or speed and there are no concurrent clinical symptoms The decision to change the controller or what other action is needed will be based on the log
60. ed electrical outlet to charge batteries The power indicator is green when the battery charger is properly connected to electrical power Each battery slides into a bay and is connected to the battery charger It is safe to leave the batteries in the charger and the charger plugged into a wall outlet at all times 54 HeartWare Ventricular Assist System Instructions for Use Figure 52 Battery charger The charger has two indicators for each charging bay The indicators are Ready and Status The green light adjacent to the Ready indicates that the battery is fully charged Figure 53 Figure 53 Battery charger indicators 1 Ready 2 Status 3 AC Power Battery being charged NOT ready for use Battery not charging Flashing Yellow Check battery connections If connections are intact switch to another battery slot If problem persists return battery to HeartWare a Battery too cold or too hot waiting to charge Defective battery Do NOT use Mark battery and return to HeartWare Flashing Red CAUTION ONLY use the HeartWare Battery Charger to charge HeartWare Batteries Other battery chargers will not charge the batteries and may damage them CAUTION ALWAYS wait until the Ready light turns on to disconnect the battery from the battery charger If this is not followed over consecutive charging cycles the Battery Capacity Display will not function properly and may convey misleading ba
61. el details conditions for transport and storage The device label details the environmental condition limits under which the device should be operated 90 HeartWare Ventricular Assist System Instructions for Use APPENDIX D EMC MANUAL REQUIREMENTS GUIDANCE DOCUMENT Electromagnetic Compatibility Medical electrical equipment needs special precautions regarding electromagnetic compatibility EMC and needs to be installed and put into service according to the EMC information provided in this user manual Portable and mobile radio frequency RF communications equipment can affect medical electrical equipment Guidance and Manufacturer s Declaration Electromagnetic Emissions The HVAD Pump is indicated for use in the electromagnetic environments specified below The customer or the user of the HVAD Pump should assure it is used in such an environment EmissionsTest Compliance Guidance O O OOOO O eee ale The HVAD Pump uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class B CISPR 11 Harmonic Emissions Complies The HVAD Pump is suitable for use in all establishments including domestic establishments and those directly connected IEC 61000 3 2 to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage Fluctuations Flicker Complies E
62. er exceeds 3 Watts do not use the pump set it aside and repeat this process using the backup HVAD Pump 68 HeartWare Ventricular Assist System Instructions for Use 16 After the test is complete disable the no power alarm If a red alarm adapter is available insert it into the blue connector on the backup controller If no alarm adapter is available press and hold the Alarm Mute and Scroll Buttons until a beep is heard or for at least 5 seconds Remove the battery from the controller This will power down the controller and will stop the pump 17 Wearing clean dry gloves disconnect the driveline extension cable from the controller and the HVAD Pump 18 Connect the driveline cap to the driveline by pushing both connectors together until you feel a click Figure 61 Protect the connector from exposure to fluids E Figure 61 Driveline cap connection 19 Cover the inflow cannula of the HVAD Pump with the yellow inflow cap 16 3 Outflow Graft Attachment 1 Examine the outflow graft package It must be unopened and without visible damage WARNING DO NOT implant gel impregnated vascular prostheses in patients who exhibit sensitivity to polyester or materials of bovine origin as severe reactions may occur 2 Open the package aseptically talking care not to contaminate the sterile graft WARNING DO NOT allow the Gelweave prostheses non sterile foil pouch or outer tray to be intr
63. er power connector CAUTION DO NOT force connectors together without proper alignment Forcing together misaligned connectors may damage the connectors CAUTION ALWAYS confirm that the power cables are properly locked on the controller by gently pulling the cable near the controller power connector or the power cables may come loose and result in an alarm or the pump stopping 12 2 Care of Batteries z OO on A a a To preserve battery life batteries should be stored at room temperature Protect batteries from extreme high and low temperatures Avoid storage in direct sunlight Protect the battery connectors from moisture dirt and metal at all times Handle connectors so as to avoid touching the inside Do not drop the batteries or let them hit hard objects Do not let batteries get wet Do not twist or kink battery cables Do not force battery connection to the controller or battery charger Batteries should be stored in the battery charger Store batteries fully charged 53 HeartWare Ventricular Assist System Instructions for Use CAUTION DO NOT expose batteries to temperatures outside the storage and operational ranges or they may provide less support than usual To preserve battery life batteries should be stored at room temperature Battery operating and storage temperatures a Operating discharge normal use with the HeartWare System and charge while on battery charger 0 C to 45 C 32 F to 113 F
64. er to Match the Primary Controller A backup controller should always be available and programmed identical to the primary controller The backup controller should be programmed before the implant procedure prior to patient transfer from the operating room when the primary controller is replaced and upon any parameter change to the primary controller Parameters include Pump speed Hematocrit setting VAD ID Pump serial number Suction Response setting Controller date and time Low Flow Alarm limit High Power Alarm limit 8 Patient ID E a a See section 16 1 for instructions on programming the controller and removing power from the backup controller 17 0 HVAD PUMP EXPLANT 17 1 At Transplant 1 Surgically expose the HVAD Pump and sewing ring 2 Place patient on cardiopulmonary bypass according to institutional guidelines 3 Connect the controller to the monitor and turn off the HVAD Pump 4 Cross clamp two 2 sections of the outflow graft 5 Cut outflow graft between two 2 clamps 6 Cut and remove the percutaneous driveline 7 Remove the HVAD Pump with the heart 75 HeartWare Ventricular Assist System Instructions for Use 17 2 Myocardial Recovery Pump Exchange 1 10 11 12 13 14 15 16 Surgically expose the HVAD Pump and sewing ring Place patient on cardiopulmonary bypass according to institutional guidelines Connect the controller to the monitor and turn off the HVAD
65. ese 75 patients showed a mean distance walked of 246 meters a mean change of 150 meters from baseline 22 HeartWare Ventricular Assist System Instructions for Use Table 15 Functional Status 6 Minute Walk Baseline Senge Tom Baseline Distance Walked in Meters e e Mean SD 89 4 141 3 246 0 203 9 150 1 214 1 95 Cl 65 1 113 7 199 1 292 9 100 5 199 8 Figure 3 6 Minute Walk Test 246 204 244 205 89 141 94 149 Meters Walked Baseline 132 6 Month Follow Up Baseline 74 6 Month Follow Up patients 75 patients patients 74 patients Table 16 shows a breakdown of results of patients who walked at both baseline and at 6 months as well as those patients that did not walk at baseline but did walk at 6 months Table 16 6 Minute Walk Breakdown of Patients Walking vs Not Walking at Baseline HeartWare System Patients Baseline m Month m Patients walking at baseline and at 6 months 260 140 n 25 338 202 n 25 Patients NOT walking at baseline for any reason N A 333 125 n 30 but walking at 6 months 23 HeartWare Ventricular Assist System Instructions for Use 7 5 8 0 Overall Conclusions from Clinical Data The HeartWare System bridge to transplant study ADVANCE was a multi center prospective contemporaneous control trial The purpose of this study was to evaluate the safety and effectiveness in patients listed for cardiac tra
66. eters are also displayed next to the alarm Alarm Leg wwe bd yy Peet O tior tuite MAA See Wate MIRA MIA MA A TEFAL GS S ep wea AUER MIT 1 WA hee Pam T Ware vipe IZA MA AA IAB ME of Wate a 120 7 MITA pep Was MIDI MIS sep Wate ate Loew lee mins Mu Low e TEESI lse ee wipe myrs tow lie MIRA hate HWI234867 POD 3 podras 1 4111 2 E HeartWare Figure 21 Alarm Log The Troubleshooting tab displays active high and or medium priority alarms and potential causes for each alarm Figure 22 Low priority alarms are not displayed in the Troubleshooting tab 35 HeartWare Ventricular Assist System Instructions for Use ni Troubleshooting VAD STOPPED 1 Driveline Disconnect 1 2 Driveline Fracture 1 J Connector Mallunction broken 4 VAD Electrical Failure HWI1239456T POD 0 17 07 07 1 4111 2 E HeartWare Figure 22 Troubleshooting tab 10 3 Trend Screen The Trend Screen Figure 23 is accessed by pressing the Trend Screen amp Icon Waveform trend data is accessed on the Trend Screen by pressing the Flow Speed tab or Flow Power tab Flow L min and speed RPM or flow L min and power Watts can be displayed Use the Display Interval button to select between the following time intervals 60 minutes 4 hours 24 hours 14 days or 30 days a x on cs a Power 1234387 POD 0 Jose 1 E 2 UN HeartWare Figure 23 Trend Screen Trend data is uploaded from the cont
67. events was seen with the HeartWare System in this initial cohort of patients Forty percent of the ischemic stroke patients were ultimately transplanted Thirty percent of ischemic stroke patients lost transplant eligibility while thirty percent were alive and remained eligible for transplant One hundred percent of the hemorrhagic stroke patients died or lost transplant eligibility as a result of these neurological events During the continued access phase CAP data was captured on patients receiving HVAD pumps with sintered inflow cannula This device modification is incorporated in the PMA approved commercial device and is intended to allow for increased tissue ingrowth around the inflow cannula The stroke incidence in patients receiving these devices is lower than that of patients receiving devices with the non sintered inflow cannula The adverse event information for the CAP patients who received sintered versus non sintered cannula pumps is shown below Table 9 Perioperative Neurologic Events for Sintered vs Non Sintered Pumps in CAP Cohort Sintered N 60 Non Sintered N 132 INTERMACS Category 0 30 Days 0 30 Days Events 0 30 Days 0 30 Days Events Adverse Events Pts Pts 0 30 Pts Pts 0 30 Days Days Ischemic CVA 0 0 0 O i 3 0 4 Hemorrhagic CVA 2 3 3 2 3 2 3 TIA 0 0 0 0 2 1 5 2 17 HeartWare Ventricular Assist System Instructions for Use Table 10 Late Neurologic Events for Sintered vs Non
68. file analysis and the patient s clinical condition e The patient should be instructed to change the controller and return to the implanting center as soon as is reasonable within 12 16 hours if one of the following occurs o The controller fault alarm is occurring frequently more than 1 time per hour with increasing frequency o If the controller fault alarm has occurred and not resolved o Ifthe controller fault alarm has occurred in conjunction with other alarms and is associated with a change in pump flow speed or power or any adverse clinical symptom such as light headedness or shortness of breath o Download the log files from the original controller and the current controller and send them to HeartWare for analysis When a medium alarm resolves there is no audible alarm or light displayed in the Alarm Indicator located on the controller However the message on the controller display will remain until the message is cleared by pressing the Scroll Button A new alarm will also clear a resolved medium alarm from the controller display For instructions on how to silence mute an alarm see section 15 5 The Controller Display and Alarm Indicator will continue to display all active alarms Any new alarm condition will inactivate the 60 minute mute The controller fault alarm audio can be permanently silenced but this cannot be done by the patient requires the monitor see Section 10 4 3 Alarm Settings Tab 61 HeartWare Ven
69. for Use performance improves A cardiac index of 2 6 L min m2 is the lower limit of normal for a healthy adult e Maintain anticoagulation within the recommended INR range of 2 0 3 0 e Check for ASA resistance with a reliable test e g VerifyNow and adjust ASA mono therapy accordingly or consider combination therapy such as ASA 81 mg plus Aggrenox ASA plus extended release dipyridamole or daily ASA 81 mg plus Plavix 75 mg In general mono therapy with ASA is not encouraged in the absence of testing for resistance WARNING Do not use the HeartWare System in pregnant women Any woman receiving a HeartWare System who is of childbearing age and sexually active should use a reliable method of birth control Use of anticoagulants during pregnancy has been associated with birth defects and bleeding WARNING NEVER disconnect both power sources batteries and AC or DC adapter at the same time since this will stop the pump At least one power source must be connected at all times WARNING DO NOT rely only on flow estimation to assess cardiac output An average estimated flow on the monitor or controller display of less than 2 L min or greater than 10 L min may indicate an electrical fault incorrect hematocrit entry or an occlusion due to thrombus or other materials e g tissue fragments in the device Inaccurate assessment of HVAD Pump flow may lead to less than optimal treatment WARNING ALWAYS investigate and if possible correct
70. handle to the tunneling rod depress the locking pin insert the tunneling rod into the handle until it bottoms out release the locking pin and rotate the handle until the locking pops out Using the tunneler tunnel the driveline lead to the point of exit Adjust distance of exit site from costal margin to fit body habitus and prevent rubbing against the costal margin WARNING ALWAYS position the driveline exit site so that the tunneler does not contact any vital organs or structures CAUTION The driveline connector is made of nickel coated brass which may cause a rash in patients with a nickel allergy CAUTION ALWAYS be aware of the position of the driveline to avoid damage by surgical instruments and needles during HVAD Pump implantation and or re operation Once the tunneling path has been made screw the driveline cap on to the tunneling rod tip as shown in Figure 68 Pull the driveline through the tunneling path once it is secured to the tunneling tool 73 HeartWa re Ventricular Assist System Instructions for Use ES Figure 68 Driveline cap attachment to tunneler NOTE Failure to follow instructions on protecting the driveline connector or improper use of the driveline cap could result in contamination or damage to the connector and electrical fault alarms could occur Disconnect the tunneling rod from the driveline cap Do not remove the driveline cap until it is time to connect the drivelin
71. he Gelweave prostheses as it will damage the polyester fibers and the gelatin impregnation which may result in bleeding CAUTION ALWAYS ensure the inflow cannula position is pointed toward the mitral valve and parallel to the interventricular septum to optimize HVAD Pump operation CAUTION ALWAYS position the sewing ring to permit access to its screw after cannulation CAUTION ALWAYS use round body taper point needles when implanting Gelweave prostheses to minimize fiber damage A kinked or compressed outflow graft may lead to reduced flow and or thrombus formation CAUTION The driveline connector is made of nickel coated brass which may cause a rash in patients with a nickel allergy CAUTION ALWAYS be aware of the position of the driveline to avoid damage by surgical instruments and needles during HVAD Pump implantation and or re operation CAUTION ALWAYS use the smallest possible needle for de airing 19 gauge is normally sufficient Hypodermic needles have a cutting point which may result in blood leakage and may require repair by suturing CAUTION DO NOT rely on HVAD Pump flow estimation during the de airing procedure Flow estimation may not be accurate CAUTION Chest compressions may pose a risk due to pump location and position of the outflow graft on the aorta use clinical judgment If chest compressions have been administered confirm function and positioning of HVAD Pump HeartWare Ventricular Assist System I
72. he HeartWare System is required before using this product Failure to understand these principles applications and risks may result in improper operation of the system and potential harm to the patient or to the user 2 WARNING Carefully read this entire manual prior to implanting or operating the device Improper operation of the system and potential harm to the patient and to the user could result 3 WARNING Serious and life threatening adverse events including stroke have been associated with use of this device A user must fully consider the risks of this device with that of other treatment modalities before deciding to proceed with device implantation Please see Section 6 4 for a summary of the stroke data To mitigate the risk of stroke please adhere to the following patient management guidelines e Maintain MAP at lt 85 mm Hg as tolerated The HVAD Pump is sensitive to both preload and afterload e Ramp speed and flows more slowly during the first few weeks e g 30 days post implant to avoid excessive hemodynamic forces that may damage fragile blood vessels that have undergone remodeling secondary to the lower pressures and reduced flow associated with medically treated heart failure There is no apparent need to exceed a cardiac index of 2 6 L min m2 until patients have fully recovered from the implant surgery and physical 10 Li 12 13 14 15 16 17 HeartWare Ventricular Assist System Instructions
73. hed 9 4 HVAD Pump Operating Guidelines The HVAD Pump speed can be set between 1800 and 4000 RPM however the recommended clinical operating speed range is 2400 to 3200 RPM Speeds below 2400 RPM should only be used during the implant procedure when weaning from cardiopulmonary bypass Speeds above 3200 RPM are seldom needed and increase the risk of suction events HVAD Pump power ranges from 2 5 to 8 5 watts when operating within the recommended speed range Power values gt 8 5 watts suggests a problem which should be evaluated by log file analysis The table below shows the expected average values for speed power and flow at 2400 and 3200 rpms Table 17 Expected Average HVAD Pump Parameters Speed rpms Flow L min 2400 2 5 3 3200 es o e One of the operating goals for the HVAD Pump is to maintain device operation in the Normal Pulsatility Region to avoid retrograde flow and suction events HVAD Pump flow pulsatility is the difference between the minimum trough and maximum flows which are displayed in the flow waveform on the HeartWare Monitor Pulsatility is reflected in a positive waveform similar in form to an arterial line waveform where the trough value represents the flow during left ventricular diastole and the peak value represents the flow during left ventricular systole see Figure 14 below Pulsatility is affected by a number of patient conditions including left ventricular contractility right he
74. ian to do so Patients who shower must use the HeartWare Shower Bag WARNING DO NOT allow hearing impaired patients to shower unless their caregiver is close by to hear alarms WARNING DO NOT plug the controller into an AC wall outlet during showers to eliminate the possibility of a severe electrical shock it should be connected to two batteries WARNING DO NOT allow patients to take a bath or swim as this may damage HeartWare System components and or result in driveline exit site infection WARNING DO NOT submerge HeartWare System components in water or other fluid as this may damage them If this happens contact HeartWare WARNING DO NOT allow water or other fluids to enter the controller power adapters batteries battery charger or connectors as this may damage HeartWare System components If this happens contact HeartWare WARNING AVOID areas with high magnetic forces such as theft detection devices or airport security systems as this may affect HeartWare System operation WARNING Keep mobile phones at least 20 inches 50 centimeters away from the controller as mobile phones may interfere with controller operation WARNING DO NOT let the patient have a magnetic resonance imaging MRI procedure while implanted with the HVAD Pump Doing so could cause harm to the patient or could cause the pump to stop WARNING DO NOT apply high power electrical treatment e g application of diathermy directly to the p
75. ible to have concurrent alarm conditions For multiple alarms the Alarm Indicator A will display the color of the most severe alarm and the alarm will sound the most severe alarm An arrow is displayed on the right side of the alarm for multiple alarms Figure 59 Use the Scroll Button to see all active alarms 62 HeartWare Ventricular Assist System Instructions for Use Figure 59 Controller displaying multiple alarms Alarm Indicator and Alarm Sound for Multiple Alarms Multiple Al Alarm Indicator o A Alarm Sound More than 2 High Alarms Loud continuous unable to mute High and Medium Alarm Loud continuous unable to mute High and Low Alarm Loud continuous unable to mute M han 2 Medi E Tae l li if al NOT ore than edium Flashing YELLOW Gradual increase in volume if alarm NO Alarms muted TEEF Gradual i i if al NOT Medium and Low Alarm Flashing YELLOW E ee muted Gradual increase in volume if alarm NOT More than 2 Low Alarms YELLOW muted NOTE If an arrow is displayed on the right side of the alarm message there are multiple active alarms Use the Scroll Button to see all alarm conditions Press the Scroll Button to advance to the next alarm or to the pump parameters flow speed and power If the Scroll Button is not touched for 1 minute the controller automatically displays the most severe alarm on the controller display If a new alarm occurs the controller display will show the new alarm 15 5 How to Sile
76. iderable reduction in ventricular volume Left ventricular collapse can be the result of clinical events affecting left ventricular preload including hypovolemia bleeding right heart failure arrhythmia or pulmonary embolus An inflow occlusion occurs when the inflow cannula is obstructed causing a suction condition Temporary inflow obstruction can occur as a result of surgical positioning patient position or during straining valsalva The ventricular suction detection alarm functions by monitoring the estimated flow for sudden decreases in flow rate A flow baseline is established by continuously tracking the minimum flow 29 HeartWare Ventricular Assist System Instructions for Use values A trigger value is established at 40 below the estimated flow baseline An indication of suction is obtained when the minimum flow falls below this trigger level The alarm will be triggered if this condition is maintained for 10 seconds The flow minimum that triggers the suction alarm is also used to define the suction clear limit The estimated flow baseline is continuously compared to this limit The suction alarm will be cleared if the flow baseline is maintained above the trigger level for 20 seconds This is an indication that the suction condition has cleared Estimated Flow A Waveform TUPLE EE E ku Y Y Y Suction Detect Trigger l l Suction Suction Detection Clear
77. ient must be able to demonstrate proficiency in operating the HeartWare System and in responding to emergencies In order to ensure their understanding and ability patients should be trained using hands on demonstrations At the end of the training the patient should be able to do the following e Identify the AC adapter and successfully connect it to the controller and an electrical outlet e Identify the power ports on the controller and be able to successfully replace batteries as indicated e Successfully recharge batteries with the battery charger e Monitor the remaining battery time on each battery according to LED light displays e Identify audible and text alarm messages on the controller e Understand the meaning of alarms and demonstrate appropriate responses to alarm conditions e Successfully switch from one controller to another controller e Understand the importance of not pulling twisting or kinking the driveline or power cables Following hospital discharge the patient s understanding of HeartWare System operation and alarms should be re evaluated during routine follow up visits This training should include reinforcement of the procedure for switching to a backup controller in the case of an emergency External Accessories 18 11 1 Patient Pack The patient pack is used to safely secure store and carry the controller and batteries It can be used in or out of the hospital when resting sleeping or ambulating O
78. ior to HVAD Pump implantation is an important goal 77 HeartWare Ventricular Assist System Instructions for Use 18 4 18 5 Anticoagulation should be individualized for each patient In general begin low dose heparin at 10 units kg hr on postoperative day one to a target PTT of 40 50 seconds Prior to initiation of anticoagulation chest tube drainage should be less than 40 ml hr for approximately three hours the HCT should be stable without the need for transfusion of blood products and coagulation factors approaching normal Gradually increase the heparin dosage to maintain the aPTT in a range of 50 60 seconds The recommended long term oral anticoagulation regimen for the HVAD Pump is a combination of warfarin and aspirin In general aspirin should be started at a dose such as 325 mg day within 24 hours after implant if there are no postoperative bleeding complications However if ASA alone is the medication chosen for anti platelet therapy a check for ASA resistance with a reliable test e g VerifyNow is recommended to establish the dose or to select an alternative medication Multi drug options include e ASA 81mg plus Aggrenox ASA 25 mg plus extended release dipyridamole 200 mg e ASA 81 mg plus clopidogrel 75 mg daily For patients who are aspirin sensitive or otherwise intolerant clopidogrel at doses of 75 150 mg day is a viable alternative A clopidogrel loading dose of 300 mg followed by 75 mg day is recommen
79. it Watts Controller Fault Audio Speed Set Alarm Control ila Settings HW1234567 POD 08 01 31 1 di 1 24 HeartWare Figure 39 Controller fault audio 45 HeartWare Ventricular Assist System Instructions for Use Permanently silencing the Controller Fault audible alarm is a two step process Pressing the Silence button on the monitor touch screen will bring up a confirmation box Figure 40 Pressing the Yes button will silence all current medium priority controller fault alarms Subsequent controller faults will produce new audible alarms Low Flow Alarm Limit L min Speed Control HW1234567 POD 0 gt 08 01 31 Figure 40 Permanently silence controller fault dialogue box The Electrical Fault Audio button appears during a medium priority Electrical Fault alarm Figure 41 The Electrical Fault Audio button can be used to permanently silence an electrical fault alarm However the controller and monitor will continue to display the electrical fault alarm until the condition resolves Low Flow Alarm Limit L min High Power Alarm Limit Watts Electrical Fault Audio Speed Setu Alarm Control P Settings HW1234567 POD 0 08 01 31 1 jalea 2 HeartWare Figure 41 Electrical fault audio WARNING ALWAYS investigate and if possible correct the cause of any alarm Silencing an alarm does n
80. ller connected to the running pump The alarm adapter silences the No Power alarm and should only be attached to a controller that has failed or malfunctioned and is no longer connected to a pump e If no alarm adapter is available o Press and hold the Alarm Mute and Scroll Buttons simultaneously on the original controller until a beep is heard or for at least 5 seconds o Release the Alarm Mute and Scroll buttons 8 Disconnect both power sources from the original controller The controller will be turned off and all alarms silenced 50 HeartWare Ventricular Assist System Instructions for Use 9 Slide the white driveline cover up to cover new controller s silver connector Figure 48 Figure 48 Replace driveline cover 10 Contact HeartWare to obtain a new backup controller WARNING ALWAYS keep a spare controller and fully charged spare batteries available at all times in case of an emergency 12 0 USING THE HEARTWARE BATTERIES The batteries Figure 49 contain lithium ion cells to power the HVAD Pump for approximately 4 to 6 hours when fully charged The capacity hours of support of each battery is based on e Controller and HVAD Pump operating power consumption e Number of battery charge and discharge cycles The batteries are expected to have a useful operating life of greater than 500 charge and discharge cycles If a battery provides less than two hours of support duration it should be
81. missions IEC 61000 3 3 Radiated emissions Avionics Category M The HeartWare System with 2 battery packs or one battery pack RTCA DO 160F Section 21 and controller AC adapter is compliant with all related FAA safety requirements and will not interfere with aviation electronics per Section 21 Category M of the RTCA document number RTCA DO 160F as specified in Use of Portable Electronic Devices Aboard Aircraft AC number 91 21 1B Section 8A 91 HeartWare Ventricular Assist System Instructions for Use Guidance and Manufacturer s Declaration Electromagnetic Immunity The HVAD Pump is indicated for use in the electromagnetic environments specified below The customer or the user of the HVAD Pump should assure it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Guidance Electrostatic Discharge IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage Dips Short Interrupts amp Variations on power Supply Lines IEC 61000 4 11 6 kV Contact 8 kV Air 2 kV on Power Supply Lines 1 kV on Input Output Lines 1 kV Differential Mode 2 kV Common Mode lt 5 Ur 95 dip in Uy for 0 5 cycles lt 40 Ur 60 dip in U for 5 cycles lt 70 Ur 30 dip in U for 25 cycles 6 kV Contact 8 kV Air 2 kV on Power Supply Lines 1 kV on Input Output Lines 1 kV Differential Mode 2 kV Co
82. mmon Mode lt 5 Uy 95 dip in Uy for 0 5 cycles lt 40 Ur 60 dip in U for 5 cycles lt 70 Ur 30 dip in U for 25 cycles Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment The HVAD Pump will always have a battery backup power supply connected NOTE Uy is the a c mains voltage prior to application of the test level Power Frequency Magnetic Fields IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 92 HeartWare Ventricular Assist System Instructions for Use Guidance and Manufacturer s Declaration Electromagnetic Immunity cont Immunity IEC 60601 Compliance Test Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the HVAD Pump including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 150 kHz to 80 d 1 2 P outside ISM bands
83. mp screw is on the outflow conduit and attached to the graft clamp 6 Tighten the clamp screw slightly with the hex driver then rotate the strain relief so that clamp screw is located on the inner side of the outflow conduit Figure 64 Finish tightening the clamp screw until resistance is met Figure 64 Rotate clamp screw to inner side of outflow conduit 70 HeartWare Ventricular Assist System Instructions for Use WARNING ALWAYS rotate the strain relief so that the clamp screw is located on the inner side of the outflow conduit to avoid tissue irritation or damage WARNING DO NOT use excessive force when tightening the clamp screw because this could damage the graft clamp or graft clamp screw and a loose connection may result in bleeding and or an air embolus Replace components if required 9 Gently pull on the outflow graft to verify secure placement of the graft clamp to the outflow conduit Inspect the outflow graft and strain relief for any kinks or twisting Reattach the outflow graft if necessary Clamp the HVAD Pump outflow graft with a vascular clamp then wrap it all in a clean towel 16 4 Pump Implantation Preparation 1 Ze 3 Make a standard median sternotomy incision Open the pericardium to expose and access the left ventricle LV apex Consider a transesophageal echocardiography TEE prior to placing the patient on cardiopulmonary bypass to assess for a patent foramen ovale PFO If prese
84. nce Mute Alarms High alarms CANNOT be silenced However medium and low alarms may be silenced for 5 minutes by pressing the Alarm Mute Button Clinicians can also mute medium alarms for one hour by pressing and holding the Alarm Mute Button then pressing and holding the Scroll Button followed by releasing the Alarm Mute Button and finally releasing the Scroll Button The alarm will sound again if a new alarm condition occurs during the mute interval The medium priority Electrical Fault alarm and Controller Fault alarm can be permanently disabled by accessing the Alarm Settings in the monitor s System Screen see Section 10 4 3 63 HeartWare Ventricular Assist System Instructions for Use WARNING ALWAYS investigate and if possible correct the cause of any alarm Silencing an alarm does not resolve the alarm condition 15 6 Status Message Display The monitor may display a status message where alarms are typically displayed The following are potential status messages Message Potential Causes Driveline connected to controller and HVAD Pump manually VAD Off stopped Patient data cannot be stored due to maximum number of patients Data Limit or lack of storage space NOTE The monitor will overwrite files at its data limit which is based on the amount of hard disc space used The USB flash drive can be used to transfer log files 16 0 SURGICAL IMPLANT PROCEDURE NOTE In order to optimize pa
85. ndition clears an accurate baseline will be obtained automatically and the suction detection will proceed NOTE Ventricular suction detection may be activated once the patient s intravascular volume and pump flow have been stabilized If a ventricular suction detection alarm is triggered the clinician should evaluate whether the alarm was triggered by a transient reversible condition which corrects itself or whether the alarm is more serious and requires intervention Transient alarms often occur at certain times during the day and or under particular circumstances such as bending over or lying on one side They usually resolve quickly without problems If the ventricular suction detection alarm is persistent and there are clinical symptoms of decreased blood flow such as dizziness or hypotension or if a Low Flow alarm is active then the patient should be evaluated This can be accomplished by checking the pump flow waveform on the monitor for evidence of suction or if necessary by visualizing the left ventricle with 30 HeartWare Ventricular Assist System Instructions for Use echocardiography Next the clinician should attempt to identify and treat the underlying cause of the suction event If the cause for the suction event cannot be determined or if the cause is refractory to treatment then the clinician should manually adjust the speed to resolve the suction condition under echocardiographic guidance Manual changes to
86. ne controller and two batteries fit into the patient pack 80 HeartWare Ventricular Assist System Instructions for Use 18 11 2 HeartWare Shower Bag A shower bag is available for use in conjunction with the HeartWare System To ensure safe and appropriate use of the shower bag all patients and caregivers should be trained on shower bag operation prior to use WARNING DO NOT allow patients to shower until they have received permission from their clinician to do so Patients who shower must use the HeartWare Shower Bag WARNING DO NOT allow hearing impaired patients to shower unless their caregiver is close by to hear alarms WARNING DO NOT plug the controller into an AC wall outlet during showers to eliminate the possibility of a severe electrical shock it should be connected to two batteries WARNING DO NOT allow patients to take a bath or swim as this may damage HeartWare System components and or result in driveline exit site infection WARNING DO NOT submerge HeartWare System components in water or other fluid as this may damage them If this happens contact HeartWare WARNING DO NOT allow water or other fluids to enter the controller power adapters batteries battery charger or connectors as this may damage HeartWare System components If this happens contact HeartWare CAUTION DO NOT pull kink or twist the driveline or the power cables as these may damage the driveline Special care should be taken n
87. nsplantation with refractory advanced heart failure at risk of death The primary endpoint was success at 180 days which is defined as alive on the originally implanted HVAD Pump or transplanted or explanted for recovery The analysis of the primary endpoint yielded non inferiority of the HeartWare System to the INTERMACS control The 95 one sided UCL on the difference in success rates was 4 5 for the Safety Group and 0 9 for the Per Protocol Group Each of these limits was less than the 15 non inferiority margin p value lt 0 0001 e The pre specified primary endpoint was achieved e Both quality of life and functional capacity showed improvements following implant of the HVAD Pump e The HeartWare System has an adverse event profile that supports its safe use for bridge to transplant patients SYSTEM COMPONENT OVERVIEW See Appendix B for a complete list of system components 8 1 HeartWare Ventricular Assist System The HeartWare System consists of a blood pump with an integrated partially sintered inflow cannula a 10mm diameter gel impregnated polyester outflow graft and a percutaneous driveline A strain relief is used on the outflow graft to prevent kinking and secures the outflow graft to the pump The driveline cable is wrapped with woven polyester fabric to encourage tissue in growth at the skin exit site The small wearless pump has a displaced volume of 50cc and weighs 160 grams The pump has one moving part
88. nstructions for Use 6 0 33 34 35 36 37 38 CAUTION ALWAYS examine the driveline for evidence of tears punctures or breakdown of any of the material during exit site dressing changes Driveline damage may affect HeartWare System performance CAUTION AVOID the use of prophylactic topical antibiotic ointments such as silver sulfadiazine betadine or polymyxin neomycin bacitracin on the tissue around the driveline exit site as these ointments can injure the tissue CAUTION DO NOT pull kink or twist the driveline or the power cables as these may damage the driveline Special care should be taken not to twist the driveline while sitting getting out of bed adjusting controller or power sources or when using the shower bag CAUTION ALWAYS keep all connectors free of liquid dust and dirt or the HeartWare System may not function as intended CAUTION DO NOT attempt to repair or service any components of the HeartWare System If HeartWare System equipment malfunctions contact HeartWare CAUTION DO NOT place batteries in water or liquid POTENTIAL COMPLICATIONS Implantation of a Ventricular Assist Device VAD is an invasive procedure requiring general anesthesia a median sternotomy a ventilator and cardiopulmonary bypass These surgical procedures are associated with numerous risks Adverse events that may be associated with the use of the HeartWare System are listed below Other than death
89. nt correct the defect prior to HVAD Pump implantation Consider flooding the field with CO when appropriate to reduce residual intracardiac air during surgery 16 5 Left Ventricle LV Apex Cannulation 1 2 Elevate the LV apex Select the insertion site for the HVAD Pump inflow cannula It should be anterior to the LV apex with the inflow cannula pointing to the mitral valve and parallel to the interventricular septum Evaluate where the HVAD Pump will sit when implanted If it appears it will directly contact adjacent rigid structures such as the chest wall consider placing the pump on the diaphragmatic surface opening the left pleural space or wrapping it in a sheet of PTFE CAUTION ALWAYS ensure the inflow cannula position is pointed toward the mitral valve and parallel to the interventricular septum to optimize HVAD Pump operation 3 Attach the sewing ring to the myocardium using 8 12 pledgeted double armed polypropylene sutures Use felt strips or a felt ring for reinforcement if necessary CAUTION ALWAYS position the sewing ring to permit access to its screw after cannulation 4 5 Perform a full thickness cruciate incision inside the sewing ring using an 11 blade scalpel Using the apical coring tool Figure 65 create and remove the apical core To use the apical coring tool e Insert the thumb in the thumb ring and wrap the first two fingers around the handle Push the ring forward with your
90. ntroller aside for use during the Pre Implant Test CAUTION A backup controller should always be available and programmed identically to the primary controller Programming Initial Settings for the Primary Controller 1 Press the Controller tab on the Monitor Setup Screen and then press the Disable VAD Stop Alarm button Connect the monitor data cable to the blue data port on the controller Plug the AC adapter into an electrical outlet Connect the primary controller to the AC adapter Connect a fully charged battery to the controller Press Speed Control tab and reduce the set speed to 1800 RPM oe ee A Press Setup tab to display Patient VAD Controller and Monitor tabs see Section 10 4 2 Setup Tab ga Press the Patient tab and enter the Patient ID and Implant Date 9 Ensure the Hematocrit setting is 30 10 Press VAD tab and enter HVAD Pump serial number and verify that Suction Response is Off 11 Press Controller tab and enter controller date and time 12 Press the Alarm Settings tab to set the Low Flow Alarm limit and High Power Alarm limits Default settings are 1 L min for low flow and 16 watts for high power 66 HeartWare Ventricular Assist System Instructions for Use 13 Press the Logout button and return to the Clinical Home Screen 14 After setting up the primary controller keep both power supplies connected to the controller so that the pump does not stop then resta
91. oduced to the sterile field or the sterile field will be contaminated Only the innermost tray is sterile WARNING DO NOT preclot the outflow graft Preclotting may disrupt the gel matrix resulting in bleeding Gelweave prostheses are sealed grafts and must not be preclotted WARNING DO NOT implant the Gelweave prostheses more than one month after removal from the foil pouch This may disrupt the gel matrix resulting in bleeding 3 Pass the outflow graft onto the sterile field WARNING DO NOT allow anyone but a surgeon physician s assistant or surgical assistant trained in the procedure to attach the outflow graft to the pump as a loose graft connection may lead to bleeding and or an air embolus 69 HeartWare Ventricular Assist System Instructions for Use 4 Slide the strain relief over the outflow graft Figure 62 Next stretch the outflow graft over the HVAD Pump outflow conduit Figure 63 Hemostats can be used to assist with the procedure Verify that the outflow graft is not kinked or twisted If necessary reattach graft if kinking or twisting occurs CAUTION DO NOT exert excessive tension or force on the Gelweave prostheses as it will damage the polyester fibers and the gelatin impregnation which may result in bleeding Figure 63 Stretch outflow graft over pump outflow conduit 5 Loosen the graft clamp screw and place the graft clamp over the lip of the HVAD Pump outflow conduit Verify that the cla
92. ogical event data available on the HeartWare Ventricular Assist System A comparison of the bridge to transplant clinical trial data to that published by Miller et al 1 and Pagani et al 2 is shown below Comparisons of the adverse events recorded in HeartWare trial patients implanted with non sintered HVAD pumps through August 23 2010 and in the perioperative period are shown in Tables Table 7 and Table 8 respectively August 23 2010 corresponds to the date of the last enrolled patient s last visit Table 7 HeartWare BTT Neurological Event Rates Compared to Literature HeartWare BTT Miller et al Pagani et al Subjects Subjects ek ci Events Events Events Affected Affected Affected 4 PPY PPY o PPY Overall TIA ICVA HCVA Other Event rates for the HVAD were calculated using 84 9 patient years Includes one spinal cord infarct event 16 HeartWare Ventricular Assist System Instructions for Use Table 8 HeartWare BTT Early Neurological Event Rates Compared to Literature Patients Affected Event Rate events PPY 0 30 Days 0 30 Days Miller Pagani Miller Pagani 3 8 2 8 0 49 0 37 1 5 1 4 0 20 0 18 1 5 1 1 0 20 0 14 23 1 4 0 29 0 18 Event rates for the HVAD were calculated using 11 2 patient years Miller et al New England Journal of Medicine August 30 2007 Pagani et al Journal of the American College of Cardiology July 21 2009 A higher level of perioperative ischemic stroke
93. onnected to the controller within 20 seconds the Power Disconnect message will be displayed on the controller display and an alarm will sound 57 HeartWare Ventricular Assist System Instructions for Use 15 0 ALARMS 15 1 Visual and auditory alarms tell clinicians and patients about the pump controller connections and power supplies batteries AC adapter DC adapter A quick reference guide for alarms is located in Appendix A Alarm conditions are classified as high medium or low Each of these alarms has a 1 unique sound 2 visual display flashing RED flashing YELLOW or YELLOW and 3 message When an alarm occurs two lines of text appear in the controller display The first line describes the alarm and the second line tells you what to do When an alarm is resolved there is no longer an alarm sound or a light displayed in the Alarm Indicator WARNING ALWAYS check the controller display for any information regarding an alarm when using loud machinery or in the vicinity of loud noises as the alarms may not be audible WARNING ALWAYS replace a controller with a blank display or no audible alarms This condition is predictive of a controller failure High Alarms A high alarm is the highest priority and loudest alarm the Alarm Indicator on the controller is flashing RED and the text message demands immediate action for VAD stoppage controller malfunction or limited power to run the pump The monitor will also displa
94. or cable and power adapters have identical connectors and attach to the controller in the same way To connect align the white arrow with the white dot and push the two halves until the connector locking mechanism latches To disconnect twist the connector counterclockwise and pull the two connectors apart 11 2 Controller Display and Operation WARNING DO NOT operate the controller in temperatures less than 20 C 4 F or greater than 50 C 122 F or the controller may fail 48 HeartWare Ventricular Assist System Instructions for Use The controller face Figure 45 incorporates a number of visual indicators and function buttons Figure 45 Controller Display AC DC Indicator Alarm Mute Button Battery Indicator 1 Alarm Indicator Battery Indicator 2 Scroll Button Controller Display HeartWare LA ee E 11 3 How to Change the Controller A backup controller and fully charged batteries must be available at all times for controller failures or malfunctions The backup controller should be set with the same pump parameters and patient information as the primary controller A controller failure or serious controller malfunction will generate a high priority or RED alarm and the controller display will tell you if you should Change Controller To change the controller 1 Have the patient sit or lie down 2 Place the new controller within easy reach 3 Connect backup power sources to the new controller Confi
95. or daily ASA 81 mg plus Plavix 75 mg In general mono therapy with ASA is not encouraged in the absence of testing for resistance gt More than thirty dichotomous covariates were considered as critical risk factors Each covariate was assessed independently as a predictor univariate analysis and covariate influence was measured with odds ratios and accompanying p values using the Cochran Mantel Haenszel test Covariate reduction was performed based on univariate analysis results and the impact of potential multicolinearity In addition important interaction terms were considered A logistic regression analysis was performed with the remaining covariate terms to generate a model for predicting stroke outcomes ADDITIONAL CLINICAL DATA Additional clinical data have been collected on the HeartWare VAS from an ongoing randomized controlled destination therapy trial ENDURANCE that should complete follow up in May 2014 Destination Therapy is for patients with end stage heart failure who are 10 years older on average and not eligible for cardiac transplantation Although the ADVANCE trial evaluated patients who were candidates for heart transplant ENDURANCE does provide concurrent control adverse event information in a set of heart failure patients receiving mechanical circulatory support A subset of the unadjudicated data from ENDURANCE up to 180 days following implant is included in 18 HeartWare Ventricular Assist System Instructions for Use
96. orted during the 180 day primary endpoint period 12 HeartWare Ventricular Assist System Instructions for Use Table 3 Summary of All Investigator Reported Adverse Events Event Total INTERMACS defined Events 437 56 3 INTERMACS Other AE s 338 43 6 UADE 1 0 1 Total 776 100 INTERMACS Events The INTERMACS defined adverse events for the 180 day primary endpoint on original device are summarized below and are separated into the perioperative 0 30 days and post perioperative 31 180 days periods Events meeting INTERMACS criteria are shown in Table 4 below Bleeding infections and arrhythmia were the most common Most bleeding events qualified due to transfusions see definition below On the other hand all reoperations due to bleeding were in the first 30 days post op 23 vs O events post 30 days Table 4 INTERMACS Events by Type and Time of Onset HeartWare System N 140 Day of Event Onset INTERMACS defined AEs 20 Da 272190 Days Subjects Subjects N N o a o o 2 e e e e e a AAA s A aal d R RES REE US A T a e Arrhythmia rr ee HeartWare Ventricular Assist System Instructions for Use Day of Event Onset INTERMACS defined AEs MEE LS DUDE Subjects Subjects N N 15 25 7 1 11 7 9 6 4 3 14 10 0 Right Heart Failure 21 15 0 17 12 1 RVAD 3 Arterial Thromboembolism 3 2 1 Venous Thromboembolism 4 4 2 9
97. ot resolve the alarm condition The user should always log off the password protected System Screens after completing system adjustments Press the Logout button and confirm by pressing the Yes button to return to the Clinical 46 HeartWare Ventricular Assist System Instructions for Use Screen If the System Screen is not used for 11 minutes the user is automatically logged out and needs to enter the password to access these screens 10 5 Monitor Shut Down The Monitor On Off NOTE Always press the On Off icon on the screen before pressing the power button on the top of the monitor or data may be lost Icon is used to shut down the monitor program A dialog box will appear after pressing the Monitor On Off Icon asking you to confirm Figure 42 Patient VAD N Controller Monitor h L min Controller 2700 11 12 10 RPM 4 3 Watts Disable VAD Stop Alarm Speed Alarm gt HW1234567 POD 3 21 24 06 1 d 2 HeartWare Figure 42 Confirming monitor shutdown Press Yes to exit the program and then press the power button switch located at the lower left corner of the monitor when the It is now safe to turn off power prompt appears on the monitor OR Press No to return to the program 11 0 USING THE HEARTWARE CONTROLLER 11 1 Controller Connector Layout There are four connectors two on either side of the controller Figure 43 The power supply
98. ot to twist the driveline while sitting getting out of bed adjusting controller or power sources or when using the shower bag 18 12 Recommended Equipment for Use at Home The minimum recommended amount of HeartWare supplied equipment needed for use at home after discharge from the hospital is 2 Controllers with AC adapters 1 Patient Pack 1 Battery charger 1 Driveline cover 4 Batteries 2 Alarm adapters 1 DC adapter 1 Shower bag Whenever patients with the HVAD Pump leave the hospital or leave their house on an excursion in addition to what they are currently using they should bring the following equipment as a backup 2 Controllers 1 AC adapter 4 Charged batteries 1 Alarm adapter 1 Patient Pack 1 Driveline cover 1 Shower bag Emergency contact information 81 HeartWare Ventricular Assist System Instructions for Use WARNING AVOID areas with high magnetic forces such as theft detection devices or airport security systems as this may affect HeartWare System operation WARNING Keep mobile phones at least 20 inches 50 centimeters away from the controller as mobile phones may interfere with controller operation WARNING DO NOT let the patient have a magnetic resonance imaging MRI procedure while implanted with the HVAD Pump Doing so could cause harm to the patient or could cause the pump to stop WARNING DO NOT apply high power electrical treatment e g application of diathermy directly to the patient as thi
99. ower source Disconnect Power 1 disconnected or e Replace power source malfunctioning e Replace controller Power Reconnect Disconnect Power 2 86 HeartWare Ventricular Assist System Instructions for Use APPENDIX B SYSTEM COMPONENTS Implantables Supplied Sterile ETO HVAD pump 10mm gel impregnated polyester graft Sewing Ring Strain Relief Surgical Tools and Accessories Supplied Sterile ETO Tunneler Rod and Handle Sewing Ring Torque Wrench Coring Tool Driveline Extension Cable Driveline Cap Hex Driver Inflow Cap Driveline Cover Externals Supplied Non Sterile Controller includes AC Adapter Power Cord Alarm Adapter Controller DC Adapter Patient Pack Shower Bag Monitor with Display Case includes AC Adapter Power Cord Data Cable Battery Charger includes Power Cord Battery USB Flash Drive Explant Kit Instructions for Use IFU Also available as individual item 87 Pump Mass or weight Volume Materials Outflow Graft Length Diameter or size Materials Strain Relief Material Driveline Length Diameter Materials Sewing Ring Materials Controller Weight Dimensions Material Display Messages Buttons Battery Type Weight Dimensions Indicators Ratings Battery Charger Capacity Recharge Time Weight Dimensions Power Source Electrical Ratings AC Adapter Weight Dimensions Electrical Ratings HeartWare Ventricular Assist System
100. p speed in increments of 20 RPM NOTE After perioperative period recommended pump speed during patient support is 2400 RPM to 3200 RPM Confirm the speed adjustment by pressing the change button The HVAD Pump button is colored and labeled according to the running state of the HVAD Pump e VAD ON means the HVAD Pump is pumping the button is RED and labeled STOP To stop VAD press STOP e VAD OFF means the HVAD Pump is NOT pumping the button is BLUE and labeled START To start VAD press START Figure 26 37 HeartWare Ventricular Assist System Instructions for Use A dialogue box will appear prompting the user to confirm each action VAD OFF y HW1234567 POD 11 21 05 38 1 qi 2 HeartWare Figure 26 System Screen VAD start 10 4 2 Setup Tab When the Setup tab is pressed four additional tabs are displayed and include Patient VAD Controller and Monitor Figure 27 The function of each is described below Patient Controller Monitor Patient ID Log Files Implant ite 05 13 11 Hematocrit Speed Control A AB124 POD 6 14 13 19 2 dejala HeartWare Figure 27 Setup tab 10 4 2 1 Patient Tab The Patient tab is used to enter Patient ID Implant Date and Hematocrit Press the Patient ID to enter patient identification The patient ID is entered by using the keypad Figure 28 The A to Z and 0 to 9 tabs allow entry of numbers
101. r The battery charger Figure 10 is used to simultaneously recharge up to four batteries It takes approximately 4 to 5 hours to fully charge a depleted battery Figure 10 Battery charger 8 6 Equipment for Implant Figure 11 shows the HeartWare System components used at implant provided ETO sterilized e HVAD Pump e Outflow graft a 10mm diameter gel impregnated graft e Strain relief to prevent outflow graft kinking e Sewing ring to secure the HVAD Pump to the left ventricle e Driveline cap to protect the driveline connector when tunneling e Inflow cap to cover the pump inflow cannula after the wet test and prior to implantation 26 HeartWare Ventricular Assist System Instructions for Use e Driveline extension cable used during the pre implant wet test to keep the non sterile controller isolated from the sterile field Figure 11 Components used at implant 1 HVAD Pump 2 Outflow graft 3 Sewing ring made of titanium and polyester 4 Driveline cap 5 Strain relief 6 Inflow cap 7 Driveline extension cable Figure 12 Surgical tools _ a 1 Tunneler to tunnel the pump s percutaneous 9 0 9 1 driveline through the skin to the exit site 2 Sewing ring wrench to tighten the screw on the sewing ring 3 Driveline cover to cover the driveline connection to the controller 4 Apical coring tool to core the LV apex 5 Hex driver to secure the strain
102. r Use 2 0 INDICATIONS FOR USE The HeartWare Ventricular Assist System is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage left ventricular heart failure The HeartWare System is designed for in hospital and out of hospital settings including transportation via fixed wing aircraft or helicopter 3 0 CONTRAINDICATIONS The HeartWare System is contraindicated in patients who cannot tolerate anticoagulation therapy WARNING Serious and life threatening adverse events including stroke have been associated with use of this device A user must fully consider the risks of this device with that of other treatment modalities before deciding to proceed with device implantation Please see Section 6 4 for a summary of the stroke data WARNING Do not use the HeartWare System in pregnant women Any woman receiving a HeartWare System who is of childbearing age and sexually active should use a reliable method of birth control Use of anticoagulants during pregnancy has been associated with birth defects and bleeding 4 0 WARNINGS 1 WARNING The Instructions for Use IFU is intended to be used by physicians nurses and other clinical professionals Setup and operation of this device should only be undertaken by personnel who have completed a HeartWare product training program A thorough understanding of technical principles clinical applications and risks associated with t
103. r this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the HVAD Pump is used exceeds the applicable RF compliance level above the HVAD Pump should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the HeartWare pump Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Recommended separation distances between portable and mobile RF communications equipment and the HVAD Pump The HVAD Pump is indicated for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the HVAD Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the HVAD Pump as recommended below according to the maximum output power of the communications equipment Rated maximum Sep
104. re 58 NOTE When pushing the connector onto the controller the white arrow will shift slightly Correct locking position white arrow aligned with white dot on controller 6 Confirm that the power cables are properly locked on the controller by gently pulling the cable near the controller power connector CAUTION DO NOT force connectors together without proper alignment Forcing together misaligned connectors may damage the connectors CAUTION ALWAYS confirm that the power cables are properly locked on the controller by gently pulling the cable near the controller power connector or the power cables may come loose and result in an alarm or the pump stopping 7 Proper connection is also verified when the AC DC Indicator on the controller turns green and the corresponding power supply indicator illuminates If the AC DC Indicator does not turn green the controller is using battery power only and a Power Disconnect alarm will sound 14 2 Disconnecting from the AC Adapter or DC Adapter Before switching from AC or DC power to battery power make sure that a fully charged battery is available Connect the fully charged battery after disconnecting the AC or DC adapter To disconnect power cables from the controller Turn the connector counterclockwise until it stops Pull the connector straight out from the controller Connect a fully charged battery to the controller power connector A a SS If a charged battery is not c
105. relief and outflow graft to the HVAD Pump All tools and accessories used during implantation are for single use only PRINCIPLES OF OPERATION Background Continuous flow pumps contain a rotating impeller that adds energy to the blood by converting the rotational kinetic energy into mechanical energy Figure 13 Impeller blades push the fluid through the pump using hydrodynamic and centrifugal forces The net effect is to build up the fluid pressure sometimes referred to as pump head i e related to the differential pressure across the device or just head such that the fluid is moved from the inlet to the outlet of the pump Pump head is the difference between the afterload and the preload Energy to rotate the impeller is provided through electromagnetic coupling between permanent magnets rotor magnet attached or enclosed within the impeller and the motor stators The motor stators consist of coils of wire that are sequentially charged by electrical current turning the coils into electromagnets These electromagnets have the effect of spinning the rotor magnets around an axis of rotation The HVAD Pump is efficient at pumping moderate quantities of blood against moderate amounts of resistance 27 HeartWare Ventricular Assist System Instructions for Use Inflow cannula Figure 13 Exploded view of HVAD pump Inflow Cannula Front Housing Assembly Impeller Center Post Rear Housing Assembly housing assembl
106. reported episode of ventricular tachycardia were subsequently placed on amiodarone Respiratory problems were more common in the perioperative period declining from 26 34 events at 0 30 days to about one third that number 8 34 from 31 180 days Subjects were more likely to experience right heart failure events in the perioperative period 20 29 The most common treatment for right heart failure was the use of inotropic drugs and the pulmonary vascular dilator nitric oxide 25 29 Three subjects required an RVAD and a fourth was exchanged for a pneumatic biVAD at 75 days post implant Ischemic strokes ICVA were more common overall 10 14 events and occurred with greater frequency in the perioperative period 7 9 perioperative strokes Four hemorrhagic strokes HCVA were recorded Three of these resulted in deaths TIAs were more common in the 31 180 day period 5 7 TIA events While HCVAs were generally fatal 75 they were most often associated with hypertension MAP gt 90 mm Hg Three of the 4 HCVAs had a mean arterial pressure of gt 95 mm Hg at the time of the stroke and the one normotensive patient was septic and had an INR of 2 7 high normal range 14 HeartWare Ventricular Assist System Instructions for Use Overall 70 of the patients who experienced ICVAs were transplanted or remained eligible It is noteworthy that 6 10 ICVA events occurred within 48 hours of implant and may have been related to surgical procedural factors
107. rious adverse events including neurocognitive status and unanticipated adverse device effects incidence of all device failures and device malfunctions Quality of Life improvement as measured by the Kansas City Cardiomyopathy Questionnaire KCCQ and European Quality of Life Assessment EuroQol EQ 5D and functional status improvement as measured by New York Heart Association NYHA classification and 6 minute walk Safety measures included the frequency and rates of adverse events overall and for each specific event which were collected throughout HeartWare System support Study Population Demographics and Baseline Parameters There were three analysis populations defined for this trial These are the intent to treat population ITT the Safety population SAF and the Per Protocol population PP HeartWare Ventricular Assist System Instructions for Use Intent to Treat Population N 140 Safety Population Per Protocol Population N 140 N 137 Major Protocol Violations N 3 Subjects were predominately male 72 1 and 53 3 10 3 years of age BSA and BMI were 2 1 0 3 kg m and 28 6 6 1 m respectively The principal etiology of heart failure was ischemic heart disease 41 and the average LVEF was 17 8 7 1 Pulmonary Capillary Wedge Pressure PCWP was elevated at 23 9 mm Hg and pulmonary artery pressures were also high 49 15 25 9 mmHg The majority of patients were classified as NYHA IV 95 Laboratory
108. rm that the power cables are properly locked onto the controller by gently pulling on the cable near the connector A Power Disconnect alarm will activate if a second power source is not connected to the new controller within 20 seconds of controller power up A VAD Stopped alarm will activate if the pump driveline is not connected to the new controller within 10 seconds This alarm will resolve once the pump driveline is connected 4 Pull back the white driveline cover from original controller s silver connector Figure 46 Figure 46 Remove white driveline cover 5 Disconnect the driveline from the original controller by pulling on the silver connector away from the controller Do not disconnect by pulling on the driveline cable A VAD Stopped alarm may activate 6 Connect the driveline to the new controller align the two red marks and push together Figure 47 If the VAD Stopped alarm was active on the new controller it will now resolve 49 HeartWare Ventricular Assist System Instructions for Use Figure 47 Connect Driveline to New Controller align the two red marks e The pump should restart The RPM L min and Watts numbers should show on controller display 7 To prevent the controller alarm from sounding after the power is removed e Ifared alarm adapter is available insert it into the blue connector on the original controller WARNING DO NOT attach the alarm adapter to a contro
109. roller to the monitor by connecting the monitor data cable to the controller see section 10 4 2 1 1 Downloading Controller Log Files 10 4 System Screen li The System Screen is accessed by pressing the HVAD Pump Icon 36 10 4 1 HeartWare Ventricular Assist System Instructions for Use a O EA laaa Taa CEE Figure 24 Password Dialog Box The System Screen is password protected HeartWare will provide the clinician with a password The dialog box Figure 24 is used to enter the numeric password User access is timed out after 11 minutes of non use Speed Control Tab The System Screen displays waveforms with real time estimated flow L min or real time power Watts The preferred waveform is selected by pressing the Flow or Power tab Figure 25 ya JIU 2800 7 RPM CO Time s a 4 0 Flow Watts VAD STOP Set RPM 2800 5 1 fae Flow L min ON Speed ee Alarm Control are Settings y HW1234567 POD 9 22 56 55 1 ARAN 2 HeartWare Figure 25 System Screen The Speed Control tab is used to adjust RPM and to turn the VAD on or off The Set RPM button is used to adjust the pump speed RPM from 1800 to 4000 and the VAD button is used to turn the pump on and off When the Set RPM button is pressed a dialog box will appear with an up arrow and a down arrow Pressing the up or down arrow will change the pum
110. rt automatically when power is restored During implant the HVAD Pump should be started only by pushing the password protected Start button 15 Place the controller in the Patient Pack carry bag and position the bag close to the head of the OR table so the driveline can be connected to the controller after tunneling WARNING Keep both power supplies connected to the controller after setting up the primary controller to minimize the risk of air embolus during implant Disconnecting and then reconnecting both power supplies will result in the controller starting the pump as soon as the driveline is connected NOTE Any changes to the primary controller should also be made to the backup controller 16 2 HVAD Pump Pre implant Test 1 Examine the HVAD Pump implant kit package and other component packaging They must be unopened and without any visible damage including abrasion delamination or punctures WARNING DO NOT use if package is damaged or opened Sterile components are intended for single use only DO NOT re sterilize or re use as this will increase the risk of infection 2 Setup a sterile back table to prepare and test the HVAD Pump 3 Open the driveline extension cable first Pass it onto the sterile field wipe it off with a damp sponge and set on sterile back table Dispose of sponge and change gloves NOTE The driveline extension cable should only be used during the pre implant test It should not be
111. s for Use WARNING To mitigate the risk of stroke please adhere to the following patient management guidelines e Maintain MAP at lt 85 mm Hg as tolerated The HVAD Pump is sensitive to both preload and afterload Ramp speed and flows more slowly during the first few weeks e g 30 days post implant to avoid excessive hemodynamic forces that may damage fragile blood vessels that have undergone remodeling secondary to the lower pressures and reduced flow associated with medically treated heart failure There is no apparent need to exceed a cardiac index of 2 6 L min m2 until patients have fully recovered from the implant surgery and physical performance improves A cardiac index of 2 6 L min m2 is the lower limit of normal for a healthy adult Maintain anticoagulation within the recommended INR range of 2 0 3 0 Check for ASA resistance with a reliable test e g VerifyNow and adjust ASA mono therapy accordingly or consider combination therapy such as ASA 81 mg plus Aggrenox ASA plus extended release dipyridamole or daily ASA 81 mg plus Plavix 75 mg In general mono therapy with ASA is not encouraged in the absence of testing for resistance NOTE Recommended HVAD Pump speeds are between 2400 RPM and 3200 RPM HVAD Pump speeds outside this range may result in less than optimal HVAD Pump operation NOTE HVAD Pump speed should be adjusted according to a calculated cardiac index During the first few weeks post implan
112. s may affect HeartWare System operation WARNING AVOID therapeutic levels of ultrasound energy as the device may inadvertently concentrate the ultrasound field and cause harm WARNING AVOID therapeutic ionizing radiation since it may damage the device This damage may not be immediately detectable 19 0 EQUIPMENT INSPECTION CLEANING AND MAINTENANCE 19 1 General Care The HeartWare System is made of durable materials that will occasionally need cleaning The following steps should be used to clean the equipment 1 Use aclean soft cloth when cleaning the system 2 Gently clean the equipment Avoid hard rubbing WARNING DO NOT use any components other than those supplied by HeartWare with the HeartWare System as this may affect HeartWare System operation WARNING DO NOT disconnect the driveline or power sources from the controller while cleaning it or the pump will stop If this happens reconnect the driveline to the controller as soon as possible to restart the pump WARNING DO NOT drop the controller or other equipment Dropping the controller could cause sudden stoppage of the pump Dropped equipment should be reported to HeartWare and inspected WARNING Damaged equipment should be reported to HeartWare and inspected CAUTION ALWAYS keep all connectors free of liquid dust and dirt or the HeartWare System may not function as intended CAUTION DO NOT attempt to repair or service any components of the Hear
113. seesasecsessccscscsersasesoessssessenbenseees 55 14 0 USING THE HEARTWARE CONTROLLER AC ADAPTER OR DC ADAPTER csecescosecscceees 56 14 1 CONNECTING THE AC ADAPTER OR DC ADAPTER TO THE CONTROLLER occoocccnccnnnccnnncnnnncnnnncnnnncononcnncncnnnnnnnss 56 14 2 DISCONNECTING FROM THE AC ADAPTER OR DC ADAPTER occcoccccnccnnncnnnncnnnncnnnoncnnonconcncnncnononcnnorcnncrnnncnnnoss 57 TIO PAEARIMIS A AR A rd 58 ISE E O 58 TA A O saute sae 59 153 LOW ALARM taa ida 62 E A A vaca teeta ec tierra versa cs aia teautee a aati an ames A 62 155 HOW TO SILENCE MUTE ALARMS sais sidvnesiehacatvaneduvetansuncaves sume aia 63 1540 STATUS MESSAGE DISPLAY aii 64 16 0 SURGICAL IMPLANT PROCEDURE iisissecicncasetise caciones 64 16 1 HEARTWARE VENTRICULAR ASSIST SYSTEM SETUP viii idas 65 162 HVAD PUMP PREIMPLANT TEST lt cisstaictonsna aciavsaissie tots N N 67 16 3 OUTFLOW GRAFT ATTACHMEN T rediras ratoni a a a aa aa a EA TONA 69 16 4 PUMP IMPLANTATION PREPARATION oiriin a E E A N 71 16 5 LEFT VENTRICLE LW APEX CANNULATION a bt dos a 71 16 6 OUTELOW GRAPT ANASTOMOSIS css sare a a A a a aS 72 1637 DRIVELINE PLACEMENT tidad 73 16 8 DE AIRING PROCEDURE solia E EENT E S EN EEN NN 74 16 9 PROGRAMMING THE BACKUP CONTROLLER TO MATCH THE PRIMARY CONTROLLER oooccoocccnnccnnocnnnoncnncncnncnnnoss 75 HeartWare Ventricular Assist System Instructions for Use 17 0 HVAD PUMVIPEXPLAN Ta 75 TEL ATTRANSPLANT eeir N cee cat dca pclae da glee gnc
114. ssings should routinely be changed Routine driveline exit site care is the responsibility of the patient and the primary caregiver For proper HVAD Pump driveline and exit site care please ensure the following 1 Use good hand washing technique before and after dressing changes 2 Always use aseptic technique 3 Change dressings per institutional protocol guidelines 4 Once the exit site dressing is removed the driveline should be visually inspected for kinks tears or other damage If blood is seen within the lumen of the driveline the implanting center should be notified immediately 78 HeartWare Ventricular Assist System Instructions for Use Infection Control Guidelines and Driveline Care based on recommendations from Multicenter Experience Prevention and Management of Left Ventricular Assist Device Infections Chinn et al ASAIO Journal 2005 51 461 470 CAUTION ALWAYS examine the driveline for evidence of tears punctures or breakdown of any of the material during exit site dressing changes Driveline damage may affect HeartWare System performance 5 Perform exit site care every 24 48 hours using an antiseptic cleansing agent such as a diluted chlorhexidine scrub solution Following aseptic cleansing rinse and dry the site to avoid tissue injury Aseptic technique should be followed anytime the dressing is removed and the exit site is exposed inspected dressed or handled When performing exit site care be
115. sterile field on the table to prevent cable movement The non sterile assistant should have the backup controller and a charged battery ready for use Completely submerge the HVAD Pump in the dextrose solution Fill the pump with dextrose and gently rotate it with the inflow cannula facing up in the dextrose to allow any trapped air to escape At least 4 inches 10 2 cm of dextrose solution must be above the VAD inflow and outflow conduits When the HVAD Pump is completely submerged in the sterile basin and is de aired point the inflow cannula towards the wall of the basin and position your hand over the VAD outflow The non sterile assistant should connect the driveline extension cable to the controller and then connect the battery to the controller Ensure that the driveline extension cable boot is pushed fully forward to cover the exposed metal driveline connector and the mating connector on the controller The pump will start at 1800 RPM WARNING NEVER turn on the HVAD Pump in air as this may damage the pump DO NOT use an HVAD Pump that was turned on without total submersion in fluid during the pre implant test and prior to implantation The HVAD Pump must be completely submerged in fluid before being turned on NOTE During the HVAD Pump Pre Implant Test a low priority alarm will sound since one of the controller power ports is empty 15 Run the pump for 30 60 seconds If at any time during this test the pow
116. stolic pulse pressures it is best to monitor the mean arterial pressure MAP MAP should be monitored and maintained at lt 85 mmHg The blood pressure should be manually auscultated however it may be necessary to use a Doppler probe If unable to manually auscultate a blood pressure or use a Doppler probe or if hypotension precludes either method consider placing an arterial line 18 9 Physical Rehabilitation 18 10 18 11 Physical Rehabilitation begins as soon as the patient admitted to the intensive care unit is stable Early extubation removal of monitoring lines and patient ambulation are encouraged Turning the patient from side to side should start once the patient is clinically stable Physical therapy and active range of motion may begin on the first postoperative day The patient may be moved to a chair and should use a bed bike exercise bicycle or treadmill as soon as possible Within a few days of LVAD implant the patient should be ambulating in the halls and performing mild exercise under the supervision of a physical therapist The nursing physical therapy and occupational therapy staff will work together to prepare the patient for hospital discharge whether to home or a rehabilitation facility If discharged to home at the clinician s discretion the patient may attend a structured outpatient cardiac rehabilitation program Patient Education Patient training is critical to ensure safe and successful outcomes The pat
117. such as ragged coring of the myocardium for inflow insertion or incomplete device de airing These issues were addressed by improvements to the coring tool and by site retraining The overall stroke survival for the combined ICVAs and HCVAs on the original device was 77 10 13 patients Venous thrombosis occurred in 5 of subjects Most of these were cases of DVT in the lower extremities In the arterial thromboembolism category a case of VAD thrombosis was treated with tPA and resolved and in another case a clot was removed from the left main coronary artery following cardiac catheterization A third case appeared to involve a shower of small emboli to the periphery No subject required permanent dialysis Psychiatric events were recorded for nine subjects 6 4 All recovered without sequelae Two hemolysis events were detected by strict INTERMACS criteria in the absence of VAD thrombosis These resolved spontaneously One subject experienced a myocardial infarction and one subject had a hypertensive event during the perioperative period Hepatic dysfunction was noted in four subjects Adverse events were generally more common in the perioperative period SERIOUS ADVERSE EVENTS A total of 452 serious adverse events on the original device occurred in 118 84 3 subjects Table 5 A total of 287 INTERMACS defined events met the definition of an SAE and 164 INTERMACS other events met the definition of an SAE Table 5 Summary of Serio
118. t excessive hemodynamic forces may damage fragile blood vessels that have undergone remodeling secondary to the lower pressures and reduced flow associated with medically treated heart failure Unless there is a clear clinical need for higher flows the cardiac index should be set at 2 6 2 8 L min m until patients have fully recovered from the implant surgery 2 3 months and or physical activities require higher levels of support Emergency Management In the event of an emergency such as a cardiac arrest patients with the HeartWare System may be defibrillated with either an internal or external defibrillator The HeartWare System can be left on nothing needs to be turned off or disconnected If chest compressions are performed confirm function and positioning of HVAD Pump once the patient is stable CAUTION Chest compressions may pose a risk due to pump location and position of the outflow graft on the aorta use clinical judgment If chest compressions have been administered confirm function and positioning of HVAD Pump Anticoagulation Prior to HVAD Pump implantation many patients with refractory heart failure have abnormal coagulation due to abnormal liver function and chronic use of anticoagulation Prolonged INR can be associated with significant postoperative bleeding The INR PTT and platelet count should be performed prior to HVAD Pump implantation The return of each of these parameters to a normal range pr
119. t of the monitor screen Pressing this icon silences the alarm for 5 minutes The upper section of the monitor screen also displays status messages mm dd yy Onset Resolved Alarm RPM L min Watts Alarm Log Troubleshooting 11 12 10 21 37 08 High Watts 3079 8 4 11 12 10 21 36 57 High Watts 3079 7 3 11 12 10 21 36 29 High Watts 3080 8 1 11 12 10 21 36 22 High Watts 3079 7 4 11 12 10 21 35 56 High Watts 3120 8 4 11 12 10 21 33 37 High Watts 2959 7 4 11 12 10 21 33 11 High Watts 3158 7 8 11 12 10 21 32 38 High Watts 3078 7 6 11 12 10 21 32 27 High Watts 3180 8 0 11 12 10 21 30 43 Low Flow 2701 3 8 11 12 10 21 30 38 Low Flow 2700 2 6 11 12 10 21 27 22 Low Flow 2701 3 6 11 12 10 21 27 08 Low Flow 2700 2 5 11 12 10 21 26 27 Suction 2696 5 1 y HW1234567 POD 3 21 38 32 1 laa 2 E HeartWare Figure 18 Monitor screen layout The bottom of each screen includes the controller data download status icon patient identification time postoperative day POD and power supply status Either the 1 or 2 will light to indicate which source is powering the controller The illuminated 2 in Figure 19 indicates that an AC or DC adapter is connected to power supply connector 2 and is operating the controller The remaining battery capacity is also displayed for battery power If one of the power sources is disconnected the corresponding icon disappears
120. tWare System If HeartWare System equipment malfunctions contact HeartWare 19 2 Controller Once a week Instruct the patient to inspect the controller power connections and connector pins for dirt This inspection can be done while the patient is changing batteries or when changing from 82 HeartWare Ventricular Assist System Instructions for Use batteries to the AC adapter Check the power connections on the controller one at a time DO NOT disconnect both power sources to examine the connections DO NOT disconnect the pump to examine the percutaneous lead controller connection This connector should be inspected only during a controller exchange The patient should not attempt to clean the controller connectors but should be instructed to contact their VAD coordinator if they notice the connectors are dirty Exterior surfaces of the controller should be cleaned using a clean cloth A damp cloth may be used but a wet cloth should not 19 3 Batteries Once a week Inspect batteries for physical damage including the battery cable and connectors for damage DO NOT use batteries that appear damaged Damaged batteries must be replaced Periodically or as needed e Ifthe battery lasts for less than 2 hours after being fully charged it should be replaced e Exterior surfaces of the batteries should be cleaned using a clean cloth A damp cloth may be used but a wet cloth should not CAUTION DO NOT place batteries in water or liquid
121. tc High blood pressure Outflow graft kink RPM too high Poor VAD filling right ventricular failure hypovolemia tamponade arrhythmias inflow cannula obstruction etc Thrombus or other materials e g tissue fragments in the device Check driveline cover and ensure driveline connector is engaged Inspect driveline for defects Download email patient log files Contact HeartWare Clinical Support Confirm VAD parameters If possible confirm correct settings for Low Flow alarm limit and viscosity Confirm blood pressure MAP lt 85 mmHg Evaluate cause of poor left ventricle filling include attaching patient to monitor to evaluate pump wave form and consider volume resuscitation if indicated If no potential patient cause can be identified download email patient log files Consider ECHO Contact HeartWare Clinical Support Confirm pump flow trends to evaluate a decrease in mean flow Download email patient log files Consider volume resuscitation and or correct cause of poor left ventricular filling Consider decreasing pump speed Contact HeartWare Clinical Support Consider ECHO Solid Yellow A Intermittent beep e Gradual increase in alarm volume over time if not muted e Able to mute alarm for 5 minutes Alarm Type Low Low Battery Replace e Battery power is low eReplace low battery 1 Battery 1 Low Battery Replace 2 Battery 2 Power Reconnect Power source is e Reconnect p
122. tempts to pump more blood than is available ventricular suction may occur The controller operates in Fixed mode which maintains a constant motor speed The motor speed range is between 1800 and 4000 RPM The appropriate speed should be determined based on the patient condition NOTE Recommended HVAD Pump speeds are between 2400 RPM and 3200 RPM HVAD Pump speeds outside this range may result in less than optimal HVAD Pump operation 9 3 Physiological Control Algorithms The HVAD Pump control algorithms provide clinicians information about device performance and HVAD Pump blood flow estimation 28 9 3 1 9 3 2 HeartWare Ventricular Assist System Instructions for Use Flow Estimation Estimated HVAD Pump blood flow is calculated using VAD power speed parameters and hematocrit based on a blood sample from the patient The default hematocrit setting is 30 but for accurate flow estimation the patient s hematocrit should be entered into the monitor Adjustments to the hematocrit setting on the monitor should be made for hematocrit changes of 5 or greater NOTE Update hematocrit settings on the monitor whenever hematocrit changes by plus or minus 5 or more The valid range of estimated blood flow is 2 to 10 L min The table below shows monitor and controller display messages and what they mean Monitor and Controller Display Estimated Flow Range al al 2 0 L min up to 10 0 L min
123. terference with AICD sensing may require adjustment of lead sensitivity proximal placement of new leads or replacement of an existing sensing lead CAUTION DO NOT use HeartWare equipment in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Battery Charger 1 Connect the battery charger power cable to an electrical outlet Verify the power indicator is lit next to HeartWare 2 Verify availability of four fully charged batteries If batteries are not fully charged start charging depleted batteries at least 4 hours before the HVAD Pump implant procedure Monitor 1 Connect the monitor power cord to an electrical outlet 2 Turn the monitor on The monitor program will appear in a few minutes 3 Connect the monitor data cable to the serial port on the monitor and to the blue connector on the controller 4 Press the HVAD Pump Icon to access the System Screen and enter the password see section 10 4 for more detail 5 Press Setup tab to display Patient VAD Controller and Monitor tabs see section 10 4 2 6 Press the Monitor tab and enter monitor date and time Backup Controller 1 eS YY 1 Press the Controller tab on the Setup Screen and then press the Disable VAD Stop Alarm button Connect the monitor data cable to the blue data port on the controller Plug the AC adapter into an electrical outlet Connect the controller to the AC adapter Connect a
124. tery prior to patient use CAUTION DO NOT allow patients to touch the monitor as this may lead to the entering of unwanted HeartWare System parameters The monitor is designed to use AC power from a wall outlet The monitor can also use its internal battery during patient transportation Keep the monitor s battery charged by connecting the monitor AC adapter to an electrical outlet at all times even while in storage It takes approximately 4 hours to charge a depleted battery If the monitor is going to be stored for a long period removing the battery and leaving the monitor unplugged is also an option NOTE The monitor should always use AC power except during patient transport There are five icons Figure 17 on the monitor to access system information and to manage pump operation The icons are displayed on all screens When an icon is selected it points to the screen Clinical Alarm Trend System Monitor On Off Home Figure 17 HeartWare Monitor screen icons 33 HeartWare Ventricular Assist System Instructions for Use Pump parameters are displayed along the left hand side of all monitor screens Parameters displayed include average pump blood flow L min speed RPM and power Watts Figure 18 The top of the monitor screen displays alarm messages for active controller alarms The alarm messages are identical to those displayed by the controller During active alarms the Alarm Mute icon appears on the top righ
125. the backup controller if there is a Controller Failed alarm since the HVAD Pump may not be running WARNING The HVAD Pump may cause interference with AICDs If electromagnetic interference occurs it may lead to inappropriate shocks arrhythmia and possibly death The occurrence of electromagnetic interference with AICD sensing may require adjustment of lead sensitivity proximal placement of new leads or replacement of an existing sensing lead 3 HeartWare Ventricular Assist System Instructions for Use 18 19 20 Z Le 22 23 24 25 26 27 28 29 30 31 32 33 WARNING Keep both power supplies connected to the controller after setting up the primary controller to minimize the risk of air embolus during implant Disconnecting and then reconnecting both power supplies will result in the controller starting the pump as soon as the driveline is connected WARNING DO NOT use if package is damaged or opened Sterile components are intended for single use only DO NOT re sterilize or re use as this will increase the risk of infection WARNING ALWAYS check for an audible click when connecting the driveline to the controller or driveline extension cable Failure to ensure a secure connection may cause an electrical fault WARNING NEVER turn on the HVAD Pump in air as this may damage the pump DO NOT use an HVAD Pump that was turned on without total submersion in fluid during the pre
126. the sewing ring s screw or it may fall off the sewing ring and be lost in the sterile field WARNING DO NOT cut the outflow graft too short or too long or it may kink Prior to chest closure ensure that the graft is not kinked or compressed A kinked or compressed outflow graft may lead to reduced flow and or thrombus formation WARNING DO NOT immerse the Gelweave grafts in saline for longer than 5 minutes Longer periods of soaking in saline may disrupt the gel matrix resulting in bleeding WARNING ALWAYS position the driveline exit site so that the tunneler does not contact any vital organs or structures WARNING DO NOT grasp the driveline and pull as this may damage the driveline To remove the driveline cap from the driveline unscrew the outer sleeve then pull back on the grooved part of the connector 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 HeartWare Ventricular Assist System Instructions for Use WARNING ALWAYS remove all air from the HVAD Pump and its conduits to reduce risk of air embolus WARNING DO NOT de air the HVAD Pump when there is inadequate blood volume in the HVAD Pump or leaks in the inflow outflow connections as air may enter the HVAD Pump and outflow graft resulting in a delay in de airing and possible air embolism WARNING DO NOT allow patients to shower until they have received permission from their clinic
127. thumb extending the cutting head e After the cutting head is completely extended place the cutting head through the myocardium Release tension e Grasp the tool with one hand and use the other to rotate the cutting head as it retracts 71 HeartWare Ventricular Assist System Instructions for Use 10 e Cored tissue is captured within the cutting head Figure 65 Apical coring tool Perform a visual inspection of the left ventricle and remove any thrombus or potential obstruction to the inflow cannula Place a clamp on the HVAD Pump outflow graft Remove the inflow cap from the HVAD Pump inflow cannula and keep the HVAD Pump outflow graft cross clamped Insert the inflow cannula into the ventricle Ensure that the HVAD Pump housing is flush with the sewing ring housing Use the sewing ring wrench Figure 66 to tighten the sewing ring s screw around the HVAD Pump inflow conduit Use the wrench to tighten the screw until an audible click is heard WARNING DO NOT over loosen the sewing ring s screw or it may fall off the sewing ring and be lost in the sterile field 11 Figure 66 Sewing ring wrench Verify no blood or air leakage around the sewing ring Add reinforced pledgeted sutures as needed 16 6 Outflow Graft Anastomosis 1 Gently stretch the outflow graft measure and cut to length The outflow graft should lie without kinking or overstretching Place a partial occl
128. tient outcomes HeartWare suggests that the following techniques be considered at the time of HVAD Pump implant e TEE Inspect LA and LV for thrombus thoroughly remove any thrombus present Check for PFO PFO should be surgically repaired prior to HVAD Pump implant Coring After coring make sure margins of the core are clean and smooth Perform visual inspection of cored area and remove any loose tissue and or clots e De Airing After placement of HVAD Pump in the LV passively fill the LV and pump Elevate the apex of the heart and shake gently to remove any entrapped air in the heart HVAD Pump Clamp the distal outflow graft After anastomosis of the outflow graft to the ascending aorta complete the de airing process using standard technique e Pump Speed RPM Prior to starting the HVAD Pump the LV should be full The pump must always start at 1800 RPM Speed should be increased by no more than 100 RPM at a time Increase the HVAD Pump speed slowly to avoid suction events Suction events can lead to the ingestion of tissue clot from inside the LV and may also lead to episodes of ectopy 64 HeartWare Ventricular Assist System Instructions for Use 16 1 HeartWare Ventricular Assist System Setup WARNING The HVAD Pump may cause interference with AICDs If electromagnetic interference occurs it may lead to inappropriate shocks arrhythmia and possibly death The occurrence of electromagnetic in
129. tricular Assist System Instructions for Use 15 3 Low Alarms A low alarm is indicated by a solid YELLOW Alarm Indicator The message indicates whether to replace a low battery or reconnect a power source battery AC adapter or DC adapter The alarm gets louder after 5 minutes and even louder after 10 minutes if the alarm is not muted Low Alarms on Controller Message on Message on Alarm controller controller Meaning Indicator Alarm Sound line 1 line 2 A Low Battery 1 Replace Battery 1 Battery 1 is low Alarm gets louder YELLOW after 5 minutes and Low Battery 2 Replace Battery 2 Battery 2 is low even louder after 10 minutes if alarm not Power Reconnect Power Power source 1 Is muted Disconnect 1 disconnected or defective Able to mute alarm Power Reconnect Power Power source 2 Is for 5 minutes Press Disconnect 2 disconnected or Alarm Mute Button defective The following are Low Priority Alarms Low Battery This alarm is triggered if any batteries have a remaining capacity between 10 and 25 Power Disconnect This alarm is triggered if a controller power source is disconnected or defective The power supply should be replaced immediately because the patient will be without a backup power source WARNING NEVER disconnect both power sources batteries and AC or DC adapter at the same time since this will stop the pump At least one power source must be connected at all times 15 4 Multiple Alarms It is poss
130. ttery capacity 13 1 Connecting the Battery to the Battery Charger 1 2 3 4 The battery connects to the battery charger the same way that it connects to the controller Grasp the cable of the battery near the connector leaving the connector free to rotate Line up the solid white arrow on the connector with the white dot on the battery charger Gently push the cable onto the battery charger until it locks in place 13 2 Disconnecting the Battery from the Battery Charger 1 2 Disconnect the charged battery by turning the connector counterclockwise until it stops Pull the connector straight out from the battery charger 55 HeartWare Ventricular Assist System Instructions for Use 14 0 USING THE HEARTWARE CONTROLLER AC ADAPTER OR DC ADAPTER The AC adapter Figure 54 has cables that connect to the controller and into an electrical outlet Prior to connection to the controller verify proper connection of the power cord to the adapter Figure 55 and electrical outlet If not properly connected perform the following steps 1 Using a Philips screw driver loosen the screw at the retainer clip to allow the retainer clip to open 2 Insert the AC power cord completely and securely into the receptacle of the AC adapter 3 Tighten the screw at the retainer clip closing the retainer clip 4 Ensure that AC power cord is secure in the adapter receptacle and cannot be pulled out A green indicator light on the adapter will
131. twareinc com Website www heartware com 24 Hour Clinical Support Toll free 888 494 6365 or 888 HW INFO 5 HeartWare HeartWare Inc 14000 NW 57 Court Miami Lakes FL 33014 USA heartware com 2012 HeartWare Inc IFUOOOO1 Rev 15 11 12
132. urs to avoid permanent battery damage 10 CAUTION DO NOT force connectors together without proper alignment Forcing together misaligned connectors may damage the connectors 11 CAUTION ALWAYS confirm that the power cables are properly locked on the controller by gently pulling the cable near the controller power connector or the power cables may come loose and result in an alarm or the pump stopping 12 CAUTION DO NOT expose batteries to temperatures outside the storage and operational ranges or they may provide less support than usual To preserve battery life batteries should be stored at room temperature Battery operating and storage temperatures a Operating discharge normal use with the HeartWare System and charge while on battery charger 0 C to 45 C 32 F to 113 F Operation at temperatures below 0 C will temporarily reduce battery capacity but the battery will operate b Storage 20 C to 25 C 4 F to 77 F Long term storage outside of this range may permanently reduce the battery capacity Best condition for storage is at room temperature 13 CAUTION ALWAYS keep batteries away from children Children may be harmed by damaged batteries or components 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 HeartWare Ventricular Assist System Instructions for Use CAUTION DO NOT disassemble crush or puncture a battery CAUTION DO
133. us Adverse Events HeartWare System N 140 l Number of Subjects Serious Adverse Events SAEs SAEs N O Total Serious Adverse Events 452 118 84 3 Other 75 53 6 Device Exchange INTERMACS 287 98 70 0 Device exchange occurred in 7 patients 7 140 5 0 in the SAF population during the period 180 days post implant Of these 7 exchanges 3 were resultant from retained tissue being pulled into the pump from the ventricle in the very early post operative period and were deemed to be procedure related 2 were exchanged due to thrombus inside the pump one was exchanged for a high power event of unknown cause and one due to latent right heart failure which caused the patient to require a biventricular support system Device Malfunctions A device malfunction is defined as a failure of one or more of the components of the HeartWare System which either directly causes or could potentially cause or induce a state of inadequate circulatory support low cardiac output state or death There was information on 26 malfunctions from 20 subjects entered into the clinical database during the study period Table 6 15 HeartWare Ventricular Assist System Instructions for Use Table 6 Malfunctions by Suspected Component HeartWare System N 140 Events Device Component ID N LVAD 7 5 0 IC o ee IC e Driveline Described in Pump Exchange section Neurological Events This section contains certain neurol
134. usion clamp on the portion of the ascending aorta where the outflow graft will be placed Make a longitudinal arteriotomy and sew the outflow graft to the aorta with 4 0 or 5 0 polypropylene or similar material sutures 72 HeartWare Ventricular Assist System Instructions for Use 4 Remove the partial occlusion clamp from the aorta and ensure an intact anastomosis without bleeding while keeping the HVAD Pump outflow graft clamped WARNING DO NOT cut the outflow graft too short or too long or it may kink Prior to chest closure ensure that the graft is not kinked or compressed A kinked or compressed outflow graft may lead to reduced flow and or thrombus formation WARNING DO NOT immerse the Gelweave grafts in saline for longer than 5 minutes Longer periods of soaking in saline may disrupt the gel matrix resulting in bleeding CAUTION ALWAYS use round body taper point needles when implanting Gelweave prostheses to minimize fiber damage A kinked or compressed outflow graft may lead to reduced flow and or thrombus formation 16 7 Driveline Placement Select the location where the driveline will exit the skin Consider the position of major organs and structures when determining the path of the tunneler Massage antibiotic solution into the external surface of the driveline s woven polyester velour Figure 67 Tunneler The tunneler Figure 67 is designed so that the handle can be attached and detached To attach the
135. ving LVADs Right heart failure usually develops within the first 24 hours after LVAD implant Warning signs include increasing right atrial pressure RAP with concurrent decreases in the pulmonary capillary wedge pressure PCWP and LVAD flow Systemic hypotension tachycardia and a decrease in urine output soon follow Volume should be given to increase the RAP to 15 18mmHg This can be accomplished quickly and easily in the operating room while the patient is on cardiopulmonary bypass Increasing the RAP to gt 20mmHg is usually ineffective After optimizing intravascular volume increasing inotropic drug support in conjunction with pulmonary vasodilators such as nitric oxide is usually effective If volume and pharmacological therapy fail a right ventricular assist device RVAD should be considered Late right heart failure weeks to months post LVAD implant is unusual but would manifest itself with similar but less acute symptoms The etiology of late right heart failure may be a progression of chronic heart disease such as coronary artery disease and or right ventricular infarction The cause of the right heart dysfunction should be identified and treated appropriately 79 HeartWare Ventricular Assist System Instructions for Use 18 8 Blood Pressure Maintenance The restoration of normal perfusion may lead to systemic hypertension in susceptible patients Since the HVAD Pump provides continuous flow resulting in narrow arterial systolic dia
136. were allowed to leave the hospital if they met additional criteria for hospital discharge Each patient was followed to 180 days death device explant for recovery or cardiac transplantation whichever occurred first Patient outcomes were compared to a contemporaneously treated cohort of patients as recorded in the Interagency Registry for Mechanical Assisted Circulatory Support INTERMACS All patients enrolled in the INTERMACS registry over the same enrollment period as the trial that met the control group inclusion and exclusion criteria comprised the control group Study Objectives Primary Objective The purpose of the HeartWare Ventricular Assist System study was to evaluate the safety and effectiveness of the HeartWare System in patients listed for cardiac transplantation with refractory advanced heart failure at risk of death The primary endpoint is success at 180 days which was defined as alive on the originally implanted device or transplanted or explanted for recovery If explanted for recovery patients must have survived 60 days post explant to be considered successful Effectiveness was measured by the primary endpoint The proportion of study patients alive transplanted or explanted for recovery at 180 days was compared to the same proportion obtained from the INTERMACS registry cohort and tested for non inferiority Secondary Objectives Including Safety Secondary endpoints included overall survival incidence of all se
137. y a ee O Rear Housing Assembly 9 2 Blood Flow Characteristics The amount of flow a rotary pump can generate is dependent upon the diameter of the impeller the geometry of the impeller blades housing design motor capacity rotational speed and pressure differential that exists across the pump This allows for in vitro pump characterization for a specific pump and is the basis for blood flow estimation The HeartWare System estimates blood flow rate using HVAD Pump characteristics electrical current impeller speed and blood viscosity Viscosity is calculated from the patient s hematocrit To obtain the most accurate estimate of blood flow the patient s hematocrit must be entered into the HeartWare monitor Flow estimation should be used as a trending tool only as it cannot adapt to changing fluid conditions see Section 9 3 1 Flow Estimation The volume of flow generated by the HVAD Pump is determined by the rotational speed of the impeller and by the pressure differential across the pump The pressure that the HVAD Pump must work against is similar to the mean arterial pressure If the pump speed RPM is set too low then the device may not generate enough forward pressure This can lead to retrograde flow flow from the aorta back through the device and into the left ventricle The maximum rotational speed is determined by how much flow is available from the right heart If the speed is set too high and the pump at
138. y alarm information High Alarms on Controller Immediate Action Required Message on Message on Alarm Controller Controller Meaning Indicator Alarm Sound line 1 line 2 A ie Both power supplies Continuous Driveline disconnected or VAD Stopped Connect Driveline connector malfunction broken VAD Stopped Change Controller Controller failure Controller Unable to Change Controller Controller failure Failed mute alarm Critical Battery 1 Limited battery 1 and Repl Batt 1 ini eplace battery battery 2 time remaining Critical Battery 2 Limited battery 2 and Repl Batt 2 ini Space battery battery 1 time remaining The following are High Priority Alarms No Power no message If both power sources are disconnected from the controller a loud continuous alarm will sound and there will be NO message on the controller display The HVAD Pump 58 HeartWare Ventricular Assist System Instructions for Use is NOT pumping and power sources should be connected immediately If this action does not resolve the alarm condition replace the controller VAD Stopped The HVAD Pump will stop if the driveline is disconnected or if the controller fails The text message indicates whether to connect the driveline or change the controller Controller Failed Indicates a potential controller failure and the controller should be exchanged for a new controller The HVAD Pump may not be pumping WARNING ALWAYS swit

HeartWare Ventricular Assist System Instructions for Use

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