Biotronik BA0T Philos DR-T (aka Actros C-T) User Manual

Biotronik, Inc. Philos DR-T (aka Actros C-T)

Contents

User Manual

EXHIBIT O – User Manual FCC ID# PG6BA0T
Using the BA03 DDDR Pacemaker 1Using the BA03 DDDR PacemakerCAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF, A PHY-SICIAN (OR PROPERLY LICENSED PRACTITIONER). Software SWM 1000/B-KT0.0This software must only be used for follow-ups involv-ing BA03 DDDR pacemakers. The BA03 DDDR and Actros DR pacemakers are han-dled almost the same way.➤Please consult the Actros DR+ or the SWM 1000/B-K00.0 manual for a description of Actros DR featuresIn addition to the description in the SWM 1000/B-K00.0manual, the following special features are included inthe B-KT0.0 software:• The list of pacemakers contains only the BA03 DDDR Home Monitoring device.• The Home Monitoring functions and parameters are only available with the B-KT0.0 software.• All statistical functions can be used simultaneously. No preselection is necessary.• Both the rate trend and the sensor trend can be dis-played.• The trend for the gain monitor is not available.This software can be ordered by using the followingCatalog No.:SWM 1000/B-KT0.0.A 332 076Note: This software can only be used with the BIOTRONIK programmers EPR 1000Plus and TMS 1000Plus.
Home Monitoring - Introduction 2Home Monitoring - IntroductionThe pacemaker BA03 DDDR is the newest member ofthe Actros+ family, that consists of pacemakers fortreatment of bradycardia arrhythmia. The pacemakeris identical to the Actros DR+ in that it is a rate adaptive,dual chamber system with separate atrial and ventric-ular leads and is suited for patients who need AV syn-chronous pacing. BA03 DDDR has the functionality of acurrent DDDR pacemaker and is additionally equippedwith the Home Monitoring functionHome Monitoring This function is part of a complete Home Monitoringsystem, in which information about the cardiac condi-tion of the patient can be transmitted using wirelesstechnology between implant, patient and physician.The Home Monitoring function is used to obtain mes-sages from the implant and to compile these mes-sages into tables and graphs. Thus, the course of thetherapy can be optimzied by setting up an additionalfollow-up between regularly scheduled visits, if neces-sary. The implants’ Home Monitoring function can be usedduring the entire service time of the implant or inshorter periods, e.g., a few weeks or months. Transmissionof message For the transmission of the message, the implant isequipped with a small transmitter that has a range ofapprox. 2 m. The patients’ implant data is transmittedto the respective patient device in certain, adjustableperiods. The minimum distance between implant andpatient device is 15 cm. The patient can activate thetransmission himself by application and immediateremoval of a magnet over the implant . Patient devicewith components The patient device (Fig.1) is developed for home useand consists of a mobile unit and the respective charg-ing station. The patient can also carry the mobile unitwith them in their normal daily activities. The patient device rechargeable batteries that makean operating time of about 24 h possible. The patientdevice receives messages from the implant and for-
3Home Monitoring - Introductionwards them to aBIOTRONIK Ser-vice Center viamobile communi-cations.Fig.1Patient Device withCharging StationRUC 200Cardio Report The service center compiles the messages into a com-prehensive report (Cardio Report). This Cardio Reportis tailored to the individual needs of the patient and issent to the attending physician via fax. • For further information about the patient device, please refer to the respective Users Manual.• The standard functions are described in the Actros+ family techncial manua .• The additional Home Monitoring functions of the BA03 DDDR are found in this manual
Indications and Contraindications 4 Indications and ContraindicationsFor the general indications and contraindicationsplease refer to the Actros+ Family technical manual.Basically, the indications and contraindications of theBA03 DDDR are identical to that for the rate adaptivedual chamber pacemaker Actros DR+. The special cri-teria for the Home Monitoring Function are describedas follows:Criteria for using Home MonitoringThere are no contraindications for use of the HomeMonitoring function. This function has no influence onthe diagnostic or therapeutic functionality of the pace-maker. The patient must be capable and willing tomanage certain tasks associated with Home Monitor-ing. Usage of the Home Monitoring system is inappro-priate in the following cases:• The patient can not handle the system as intended, because of their physical or psychological condition.• There is no GSM cellular service available in the local area of the patient’s home. • The patient often stays (i.e. works) in areas where it is not permitted to use mobile phones. Note: Home Monitoring does not replace the regular fol-low-up examination.When using the Home Monitoring function, the time interval between the follow-ups must not be pro-longed.Caution: The data transmitted by Home Monitoring are not suitable for diagnosis, because not all information available in the implant is being transmitted.
5Transmission of Message Transmission of MessageThe Home Monitoring function can be switched ON orOFF with the programming device. If the Home Moni-toring function is active, the transmission of theimplant data can be triggered as follows:• Periodic message at predefined time intervals• Message activated by the patientThe attending physician himself decides if the patientshould trigger a transmission by programming thisparamater ON or OFF. The patient activated messagedoes not effect the programmed periodic message. Note: Please note that with the BA03 DDDR, the Home Mon-itoring function is only possible in following pacing modes: DDD, DDDR, DDI, DDIR.Periodic MessageThe time and interval (Monitoring Interval) of the peri-odic message are programmable. For the periodicmessage, a time between 0:00 and 24:00 can be set.Generally, it is recommended to select a time between0:00 and 4:00. For every Monitoring Interval, a datastring is generated in the implant and the transmissionis activated. Patient Activated MessageApplication of a magnet over the implant activates atransmission. The attending physician should informthe patient in detail about the handling and the physicalsymptoms that suggest a magnet application by thepatient. Caution: The magnet effect must be programmed "synchro-nous" if the attending physician enables the patient to transmit messages.
Diagnostic Memory Functions 6 Diagnostic Memory Functions BA03 DDDR has the same standard functions as theActros DR+, with the exception that the Gain Monitor isunavailable. Contrary to the Actros DR+, the BA03DDDR has the ability to use all memory functionssimultanously. When the Home Monitoring function is activated, thefollowing diagnostic memory functions are recordedautomatically and transmitted by the Home MonitoringSystem:Event CounterThe function Event Counter can record the followingevents:• As percentage• Vs percentageEvent sequences:• As - Vs percentage•As - Vp percentage• Ap - Vs percentage• Ap - Vp percentageWith every periodic message, the counter is reset.
7Diagnostic Memory FunctionsArrhythmiaVES ClassificationsThe VES events are classified according to their com-plexity. The following classifications are available:1. Number of Single-VESEvent sequence A-V-VES-A...2. Number of VES Couplets:Event sequence A-V-VES-VES-A.3. Number of VES Triplets:Event sequence A-V-VES-VES-VES-A.4. Number of VES RunsSequence of 4...8 consecutive VES.Event sequence A-V-VES-VES-...-A.5. Maximum number of VES /h6. Number of Ventricular Tachycardias:VT with duration > 8 VES and ≥ 120 bpmActivity ChartThis function records data, that are characteristic forthe activities of patient and pacemaker system:• Mean value of actual ventricular heart rate • Maximum value of actual ventricular heart rate• Activity duration at maximum sensor rate
Functions of Home Monitoring 8 Functions of Home MonitoringProgrammable ParametersThe functions of Home Monitoring and theirparameters can be set with the programmers EPR1000plus and TMS 1000plus. Therefore, the correspond-ing software SWM 1000/B-KT0.0 is necessaryThe functions of Home Monitoring are available only infollowing pacing modes: DDD, DDDR, DDI, DDIR. When using the Home Monitoring system, the trans-mission interval must be selected. This monitoringinterval can be from one to 30 days. If the standard set-ting is selected, data will be transmitted daily. For theperiodic message, a time between 0:00 and 24:00 isprogrammed. It is recommended that a time between0:00 and 4:00 is selected, as preset in the standard pro-gram.The patient activated message can also be pro-grammed ON or OFF. This option is deactivated in thestandard program
Technical Data 9Technical DataModesValid when Home Monitoring function is activated:DDD, DDDR, DDI, DDIRValid when Home Monitoring function is deactivated:DDD, DDDR, DDI, DDIR, DVI, DVIR, VDD, VDDR, DOO,DOOR, VVI, VVIR, AAI, AAIR, VOO, VOOR, AOO, AOOR,DDI/T, DDI/TR, DDT, DDTR, DVT, DVTR, VDT, VDTR,VVT, VVTR, AAT, AATR, VDI, OFFHome Monitoring parametersHome Monitoring Off, OnMonitoringinterval 1...(1) ...30 daysTime oftransmission 0:00...23:50 h:minPatient activateddata transmission Off, On
Technical Data 10Pulse and Timing Data1)Basic rate2) 30 ... (1) ... 88 ... (2) ... 122 ... (3) ... 140 ... (5) ... 180 ppmHysteresis2) Off; -5 ... (5) ... -50 bpmRepetitive Hyster. Off; 1 ... (1) ... 10Scan Hysteresis Off; 1 ... (1) ... 10Upper rate (UTR)2) 100; 110; 120; 130; 140; 160; 185 ppm Night Rate Off; (and basic rate settings) Tachycardia mode 2:1; WKB (automatic setting)Rate limitation2)3) 190 ... 220 ppmDynamic AV delay low; medium; high; individual; fixed AV delay values 15; 50; 75; 100; 120 ... (10) ... 200; 225; 250; 300 ms (programmable in 5 ranges)AV safety interval 100 msVentricularBlanking time 12; 16; 24; 32; 40; 48; 56; 72 msMagnet effect Auto; asynchronous; synchronousPulse amplitude AV0,1 ... (0,1) ... 4,8 ... (1,2) ... 8,4 V0,1 ... (0,1) ... 4,8 ... (1,2) ... 8,4 VPulse width AV0,1; 0,2; 0,3; 0,4; 0,5; 0,75; 1,0; 1,5 ms0,1; 0,2; 0,3; 0,4; 0,5; 0,75; 1,0; 1,5 msSensitivity AV0,1 ... (0,1) ... 1,5 ... (0,5) ... 7,5 mV0,5 ... (0,5) ... 7,5 mVRefractory period AV200 ... (25) ... 775 mV250; 300; 350; 400 ms1) 37°C, 500 Ω2) The respective intervals result from the rate f in the formula t = 60.000 / f (t in ms, f in ppm)3) In the case of an electronic failure
Technical Data 11ARP extension 0 ... (50) ... 350 msAutomatic modeconversion Off; On (in the modes DDD(R) and VDD(R))Lead polarityPace A/VSense A/V unipolar; bipolar / unipolar; bipolarunipolar; bipolar / unipolar; bipolarRate AdaptionSensor gain 1 ... 40 (in 32 steps)Autom. s. gain Off; OnSensor threshold very low; low; medium; high; very highRate increase 1; 2; 4; 8 ppm/sMax.Sensor rate1) 80 ... (5) ... 180 ppm/sRate decrease 0,1; 0,2; 0,4; 0,8 ppm/s1) In the modes DDIR-, DVIR-, VVIR-and VOOR, lower maximum sensor rates result than indi-cated here (partly depending on the selected AV interval). The respective values are displayed by the programmer.
Technical Data 12Parameter at Replacement IndicationBasic rate programmed value decreased by 11%(in the modes DVI(R), DDI(R), DVT(R), DDI/T(R),decreases by 4,5–11%, depending on the programmedAV delay)Magnet rate Pulse generator behavior after reaching ERI Pulse amplitudes programmed valuessensitivity programmed valuesHome Monitoringafter ERI 0 ...(1)...14 daysDefault 14 daysMagnet Mode Cycles 1-10 after magnet applicationAfter Cycle 11Automatic Asynch. at 80 ppm Synch. with basic rate reduced by 4.5 - 11% Asynchronous Asynch. at 80 ppm Asynch. with basic rate reduced by 4.5 - 11%Synchronous Synch. with basic rate reduced by 4.5 - 11% Synch. with basic rate reduced by 4.5 - 11%
Technical Data 13Features• Home MonitoringAdditional functions conform with Actros DR• Automatic sensor gain• Extensive VES analysis• External pulse control up to 800 ppm• Dual chamber IEGM with event marker• 24 hour trend with pacing part in %• Sensor test trend with rate forecast• Automatic mode conversion• High definition threshold test in the range of 0,1 up to 4,8 V with 0,1 V resolution•P/R wave test• Retrograde conduction test• Reaction to vasovagal syncopes•Night program• Heart rate histogram• Sensor rate histogram• Assisted follow-up• Activity chart• Event counter• Patient data memory• Analog telemetry• Temporary program activation• Controlled impulse amplitudes
Technical Data 14Default ProgramsParameter/Function Factory- Standard- SafeSettings Program ProgramHome Monitoring Off Off OffMode DDD DDDR VVIAutom. m. conversion Off Off —Basic rate 60 ppm 60 ppm 70 ppmHysteresis Off Off OffRepetitive hysteres. ——OffScan hysteresis ——OffNight program Off Off OffUpper rate (UTR) 160 ppm 160 ppm —Dynamic AV delay medium medium —Ventric. blanking time 24 ms 24 ms —Magnet effect Auto Auto AutoPulse amplitude AV3,6 V 3,6 V —3,6 V 3,6 V 4,8 VPulse width AV0,4 ms 0,4 ms —0,4 ms 0,4 ms 1,0 msSensitivity AV1,5 mV 1,5 mV —2,5 mV 2,5 mV 2,5 mVRefractory time AV425 ms 425 ms —250 ms 250 ms 300 msARP 0 ms 0 ms —
Technical Data 15Parameter/Function Factory Standard- SaveSettings Program ProgramSensor threshold —medium—Sensor gain —6 —Auto. Sensor gain. —Off—Rate increase —2 ppm/s—Max. sensor rate —120 ppm—Rate decrease —0,4 ppm/s—LeadpolarityPace A/V unipolar unipolar unipolarSense A/V unipolar unipolar unipolarStatistics standard standard standard
Technical Data 16Materials in Contact to Human TissueHousing TitaniumGrommet SiliconeConnector Receptacle Epoxy resinCoating (for unipolar Silicone (if used)devices)ProgrammerEPR 1000 plus , and TMS 1000 plus Electrical Data1)Circuit Hybrid electronics with VLSI-CMOS-ChipInput impedance AV270 kΩ330 kΩPulse form biphasic, asymmetricPolarity cathodicCurrent drainBOS, inhibited 12 µABOS, 100 % stimul. 24 µAConducting surface 36 cm2Conducting shape flattened ellipsoidal1) 37°C, 500 Ω
Technical Data 17BatteryPower Source Li/JManufacturer Wilson GreatbatchType WG 8431Voltage 2,8 VVoltage at ERI 2,5 VNominal Capacity1) 1,3 AhService TimesNominal servicetime2) 6,7 years at pulse amplitudes 3,6 VExpected servicetime3) 5,1 yearsat pulse amplitudes 3,6 VRemaining capacityat ERI in Ah 0,13Mechanical DataLead connection IS-1 (accepts unipolar and bipolar)Mass 30 gVolume 13 cm3Dimensions 6 x 45 x 57 mmX-RayIdentification EE1) Data from battery manufacturer2) Calculated with formula: T= 2740 x Cbat /(IBOS+ IEOS)3) Expected service time based on all avialable data as provided from the battery manufacturer
Technical Data 18Tolerances of Factory Settings1)Data according to EN 50 061Basic rateInterference rate 60 ± 1 min-1Basic interval 1000 ± 3 msEscape interval 1000 ± 5 msMagnet rate 90 ± 1 min-1 (for 10 cycles)Magnet Interval 664 ± 2 ms (for 10 cycles)AV delayBasic rate≤70 ppm70-90 ppm91-110 ppm111-130 ppm ≥130 ppm180 +3/-1 ms180 +3/-1 ms160 +15/-5 ms140 +15/-5 ms120 +15/-5 ms100 +15/-5 msAtrium VentriclePulse amplitudePeak valueEN 50061 mean 3,6 +0,25 V/ -0,45 V 3,6 +0,25 V/ -0,45 V3,3 +0,25 V / -0,45 V 3,3 +0,25 V / -0,45 VPulse width 0,43 ±0,02 ms 0,43 ±0,02 msSensitivity15 ms sin240 ms sin2EN 50061 Triangle1,5 ±0,5 mV 2,5 ±0,5 mV1,8 ±0,5 mV 2,5 ±0,5 mVRefractory period 425 +5 / -20 ms 250 +5 / -20 msRun-away protection 210 ±20 min-1 210 ±20 min-11) 37°C, 500 Ω
Technical Data 19 Order Information Model Lead Connection Order NumberBA03 DDDRuncoated IS-1 122 126Federal Communications Commission DisclosureThe BA03 DDDR pacemaker is equipped with an RF transmitter for wireless communications. This transmitter is authorized by rule under the Medical Implant Communications Service (47 CFR Part 95) and must not cause harmful interference to stations operating in the 400.150 - 406.000 MHz band in the Meteorological Aids (i.e., trans-mitters and receivers used to communicate weather data), the Meteoro-logical Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such aids, including interfer-ence that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Implant Communications Service. Analog and digital voice communi-cations are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference.The FCC ID number for this device is: PG6BA0T.

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