Biotronik BA0T Philos DR-T (aka Actros C-T) User Manual
Biotronik, Inc. Philos DR-T (aka Actros C-T)
Contents
- 1. User Manual
- 2. Revised User Manual
User Manual
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| Document ID | 136332 |
| Application ID | +atMuy1dmP4hZ7qivNzfxQ== |
| Document Description | User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 13kB (162444 bits) |
| Date Submitted | 2001-02-13 00:00:00 |
| Date Available | 2003-03-25 00:00:00 |
| Creation Date | 2001-02-08 13:09:56 |
| Producing Software | Acrobat Distiller 3.01 for Windows |
| Document Lastmod | 2001-02-09 09:31:04 |
| Document Title | User Manual |
| Document Creator | FrameMaker 5.5.6p145 |
EXHIBIT O – User Manual FCC ID# PG6BA0T Using the BA03 DDDR Pacemaker Using the BA03 DDDR Pacemaker CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF, A PHYSICIAN (OR PROPERLY LICENSED PRACTITIONER). Software SWM 1000/B-KT0.0 This software must only be used for follow-ups involving BA03 DDDR pacemakers. The BA03 DDDR and Actros DR pacemakers are handled almost the same way. ➤ Please consult the Actros DR + or the SWM 1000/BK00.0 manual for a description of Actros DR features In addition to the description in the SWM 1000/B-K00.0 manual, the following special features are included in the 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 displayed. • The trend for the gain monitor is not available. This software can be ordered by using the following Catalog No.: SWM 1000/B-KT0.0.A Note: 332 076 This software can only be used with the BIOTRONIK programmers EPR 1000Plus and TMS 1000Plus. Home Monitoring - Introduction Home Monitoring - Introduction The pacemaker BA03 DDDR is the newest member of the Actros+ family, that consists of pacemakers for treatment of bradycardia arrhythmia. The pacemaker is identical to the Actros DR+ in that it is a rate adaptive, dual chamber system with separate atrial and ventricular leads and is suited for patients who need AV synchronous pacing. BA03 DDDR has the functionality of a current DDDR pacemaker and is additionally equipped with the Home Monitoring function Home Monitoring This function is part of a complete Home Monitoring system, in which information about the cardiac condition of the patient can be transmitted using wireless technology between implant, patient and physician. The Home Monitoring function is used to obtain messages from the implant and to compile these messages into tables and graphs. Thus, the course of the therapy can be optimzied by setting up an additional follow-up between regularly scheduled visits, if necessary. The implants’ Home Monitoring function can be used during the entire service time of the implant or in shorter periods, e.g., a few weeks or months. Transmission of message For the transmission of the message, the implant is equipped with a small transmitter that has a range of approx. 2 m. The patients’ implant data is transmitted to the respective patient device in certain, adjustable periods. The minimum distance between implant and patient device is 15 cm. The patient can activate the transmission himself by application and immediate removal of a magnet over the implant . Patient device with components The patient device (Fig.1) is developed for home use and consists of a mobile unit and the respective charging station. The patient can also carry the mobile unit with them in their normal daily activities. The patient device rechargeable batteries that make an operating time of about 24 h possible. The patient device receives messages from the implant and for- 3 Home Monitoring - Introduction wards them to a BIOTRONIK Service Center via mobile communications. Fig.1 Patient Device with Charging Station RUC 200 Cardio Report The service center compiles the messages into a comprehensive report (Cardio Report). This Cardio Report is tailored to the individual needs of the patient and is sent 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 Indications and Contraindications For the general indications and contraindications please refer to the Actros+ Family technical manual. Basically, the indications and contraindications of the BA03 DDDR are identical to that for the rate adaptive dual chamber pacemaker Actros DR+. The special criteria for the Home Monitoring Function are described as follows: Criteria for using Home Monitoring There are no contraindications for use of the Home Monitoring function. This function has no influence on the diagnostic or therapeutic functionality of the pacemaker. The patient must be capable and willing to manage certain tasks associated with Home Monitoring. Usage of the Home Monitoring system is inappropriate 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: Caution: Home Monitoring does not replace the regular follow-up examination. When using the Home Monitoring function, the time interval between the follow-ups must not be prolonged. The data transmitted by Home Monitoring are not suitable for diagnosis, because not all information available in the implant is being transmitted. 5 Transmission of Message Transmission of Message The Home Monitoring function can be switched ON or OFF with the programming device. If the Home Monitoring function is active, the transmission of the implant data can be triggered as follows: • Periodic message at predefined time intervals • Message activated by the patient The attending physician himself decides if the patient should trigger a transmission by programming this paramater ON or OFF. The patient activated message does not effect the programmed periodic message. Note: Please note that with the BA03 DDDR, the Home Monitoring function is only possible in following pacing modes: DDD, DDDR, DDI, DDIR. Periodic Message The time and interval (Monitoring Interval) of the periodic message are programmable. For the periodic message, a time between 0:00 and 24:00 can be set. Generally, it is recommended to select a time between 0:00 and 4:00. For every Monitoring Interval, a data string is generated in the implant and the transmission is activated. Patient Activated Message Application of a magnet over the implant activates a transmission. The attending physician should inform the patient in detail about the handling and the physical symptoms that suggest a magnet application by the patient. Caution: The magnet effect must be programmed "synchronous" if the attending physician enables the patient to transmit messages. Diagnostic Memory Functions Diagnostic Memory Functions BA03 DDDR has the same standard functions as the Actros DR+, with the exception that the Gain Monitor is unavailable. Contrary to the Actros DR+, the BA03 DDDR has the ability to use all memory functions simultanously. When the Home Monitoring function is activated, the following diagnostic memory functions are recorded automatically and transmitted by the Home Monitoring System: Event Counter The function Event Counter can record the following events: • As percentage • Vs percentage Event sequences: • As - Vs percentage • As - Vp percentage • Ap - Vs percentage • Ap - Vp percentage With every periodic message, the counter is reset. 7 Diagnostic Memory Functions Arrhythmia VES Classifications The VES events are classified according to their complexity. The following classifications are available: 1. Number of Single-VES Event 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 Runs Sequence of 4...8 consecutive VES. Event sequence A-V-VES-VES-...-A. 5. Maximum number of VES /h 6. Number of Ventricular Tachycardias: VT with duration > 8 VES and ≥ 120 bpm Activity Chart This function records data, that are characteristic for the 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 Functions of Home Monitoring Programmable Parameters The functions of Home Monitoring and their parameters can be set with the programmers EPR 1000plus and TMS 1000plus. Therefore, the corresponding software SWM 1000/B-KT0.0 is necessary The functions of Home Monitoring are available only in following pacing modes: DDD, DDDR, DDI, DDIR. When using the Home Monitoring system, the transmission interval must be selected. This monitoring interval can be from one to 30 days. If the standard setting is selected, data will be transmitted daily. For the periodic message, a time between 0:00 and 24:00 is programmed. It is recommended that a time between 0:00 and 4:00 is selected, as preset in the standard program. The patient activated message can also be programmed ON or OFF. This option is deactivated in the standard program Technical Data Technical Data Modes Valid when Home Monitoring function is activated: DDD, DDDR, DDI, DDIR Valid 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, OFF Home Monitoring parameters Home Monitoring Monitoring interval Time of transmission Patient activated data transmission Off, On 1...(1) ...30 days 0:00...23:50 h:min Off, On Technical Data Pulse and Timing Data1) Basic rate 2) Hysteresis 2) 30 ... (1) ... 88 ... (2) ... 122 ... (3) ... 140 ... (5) ... 180 ppm Off; -5 ... (5) ... -50 bpm Repetitive Hyster. Off; 1 ... (1) ... 10 Scan Hysteresis Off; 1 ... (1) ... 10 2) Upper rate (UTR) 100; 110; 120; 130; 140; 160; 185 ppm Night Rate Off; (and basic rate settings) Tachycardia mode 2:1; WKB (automatic setting) 2)3) Rate limitation 190 ... 220 ppm Dynamic AV delay low; medium; high; individual; fixed AV delay values AV safety interval 100 ms Ventricular Blanking time 12; 16; 24; 32; 40; 48; 56; 72 ms Magnet effect Auto; asynchronous; synchronous Pulse amplitude A Pulse width A Sensitivity A Refractory period A 1) 2) 3) 15; 50; 75; 100; 120 ... (10) ... 200; 225; 250; 300 ms (programmable in 5 ranges) 0,1 ... (0,1) ... 4,8 ... (1,2) ... 8,4 V 0,1 ... (0,1) ... 4,8 ... (1,2) ... 8,4 V 0,1; 0,2; 0,3; 0,4; 0,5; 0,75; 1,0; 1,5 ms 0,1; 0,2; 0,3; 0,4; 0,5; 0,75; 1,0; 1,5 ms 0,1 ... (0,1) ... 1,5 ... (0,5) ... 7,5 mV 0,5 ... (0,5) ... 7,5 mV 200 ... (25) ... 775 mV 250; 300; 350; 400 ms 37°C, 500 Ω The respective intervals result from the rate f in the formula t = 60.000 / f (t in ms, f in ppm) In the case of an electronic failure 10 Technical Data ARP extension Automatic mode conversion Lead polarity Pace A/V Sense A/V 0 ... (50) ... 350 ms Off; On (in the modes DDD(R) and VDD(R)) unipolar; bipolar / unipolar; bipolar unipolar; bipolar / unipolar; bipolar Rate Adaption Sensor gain Autom. s. gain Sensor threshold Off; On very low; low; medium; high; very high Rate increase 1; 2; 4; 8 ppm/s Max. Sensor rate1) 80 ... (5) ... 180 ppm/s Rate decrease 1) 1 ... 40 (in 32 steps) 0,1; 0,2; 0,4; 0,8 ppm/s In the modes DDIR-, DVIR-, VVIR-and VOOR, lower maximum sensor rates result than indicated here (partly depending on the selected AV interval). The respective values are displayed by the programmer. 11 Technical Data Parameter at Replacement Indication Basic rate Magnet rate Magnet Mode 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 programmed AV delay) Pulse generator behavior after reaching ERI Cycles 1-10 after After Cycle 11 magnet application Automatic 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 Synch. with basic rate reduced by 4.5 - 11% 11% Pulse amplitudes programmed values sensitivity programmed values Home Monitoring after ERI Default 0 ...(1)...14 days 14 days 12 Technical Data Features • Home Monitoring Additional 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 13 Technical Data Default Programs FactorySettings StandardProgram Safe Program Off Off Off DDD DDDR VVI Off Off — Basic rate 60 ppm 60 ppm 70 ppm Hysteresis Off Off Off Repetitive hysteres. — — Off Scan hysteresis — — Off Night program Off Off Off Upper rate (UTR) 160 ppm 160 ppm — Dynamic AV delay medium medium — 24 ms 24 ms — Magnet effect Auto Auto Auto Pulse amplitude A 3,6 V 3,6 V 3,6 V 3,6 V — 4,8 V Pulse width A 0,4 ms 0,4 ms 0,4 ms 0,4 ms — 1,0 ms Sensitivity A 1,5 mV 2,5 mV 1,5 mV 2,5 mV — 2,5 mV Refractory time A 425 ms 250 ms 425 ms 250 ms — 300 ms 0 ms 0 ms — Parameter/Function Home Monitoring Mode Autom. m. conversion Ventric. blanking time ARP 14 Technical Data Factory Settings StandardProgram Save Program Sensor threshold — medium — Sensor gain — — Auto. Sensor gain. — Off — Rate increase — 2 ppm/s — Max. sensor rate — 120 ppm — Rate decrease — 0,4 ppm/s — Pace A/V unipolar unipolar unipolar Sense A/V unipolar unipolar unipolar Statistics standard standard standard Parameter/Function Lead polarity 15 Technical Data Materials in Contact to Human Tissue Housing Titanium Grommet Silicone Connector Receptacle Epoxy resin Coating (for unipolar Silicone (if used) devices) Programmer EPR 1000 plus , and TMS 1000 plus Electrical Data1) Circuit Input impedance A Pulse form Polarity Hybrid electronics with VLSI-CMOS-Chip 270 kΩ 330 kΩ biphasic, asymmetric cathodic Current drain BOS, inhibited 12 µA BOS, 100 % stimul. 24 µA Conducting surface 36 cm2 Conducting shape 1) 37°C, 500 Ω flattened ellipsoidal 16 Technical Data Battery Power Source Li/J Manufacturer Wilson Greatbatch Type WG 8431 Voltage 2,8 V Voltage at ERI 2,5 V Nominal Capacity1) 1,3 Ah Service Times Nominal service time2) 6,7 years at pulse amplitudes 3,6 V Expected service time3) 5,1 years at pulse amplitudes 3,6 V Remaining capacity at ERI in Ah 0,13 Mechanical Data Lead connection Mass Volume Dimensions X-Ray Identification 1) 2) 3) IS-1 (accepts unipolar and bipolar) 30 g 13 cm3 6 x 45 x 57 mm EE Data from battery manufacturer Calculated with formula: T= 2740 x Cbat /(IBOS + IEOS) Expected service time based on all avialable data as provided from the battery manufacturer 17 Technical Data Tolerances of Factory Settings1) Data according to EN 50 061 Basic rate Interference rate 60 ± 1 min-1 Basic interval 1000 ± 3 ms Escape interval 1000 ± 5 ms Magnet rate Magnet Interval AV delay Basic rate ≤70 ppm 70-90 ppm 91-110 ppm 111-130 ppm ≥130 ppm 90 ± 1 min-1 (for 10 cycles) 664 ± 2 ms (for 10 cycles) 180 180 160 140 120 100 +3/-1 ms +3/-1 ms +15/-5 ms +15/-5 ms +15/-5 ms +15/-5 ms Atrium Ventricle 3,6 3,3 +0,25 V/ -0,45 V +0,25 V / -0,45 V 3,6 3,3 +0,25 V/ -0,45 V +0,25 V / -0,45 V Pulse width 0,43 ±0,02 ms 0,43 ±0,02 ms Sensitivity 15 ms sin2 40 ms sin2 1,5 ±0,5 mV 2,5 ±0,5 mV EN 50061 Triangle 1,8 ±0,5 mV 2,5 ±0,5 mV Refractory period 425 +5 / -20 ms 250 +5 / -20 ms Run-away protection 210 ±20 min-1 210 ±20 min -1 Pulse amplitude Peak value EN 50061 mean 1) 37°C, 500 Ω 18 Technical Data Order Information Model Lead Connection Order Number IS-1 122 126 BA03 DDDR uncoated Federal Communications Commission Disclosure The 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., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such aids, including interference 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 communications 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. 19
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