User's Manual
Table Of Contents
- Home Monitoring - Introduction
- The pacemaker BA03 DDDR is the newest member of the Actros+ family, that consists of pacemakers f...
- This function is part of a complete Home Monitoring system, in which information about the cardia...
- The implants’ Home Monitoring function can be used during the entire service time of the implant ...
- For the transmission of the message, the implant is equipped with a small transmitter that has a ...
- The patient device (Fig.1) is developed for home use and consists of a mobile unit and the respec...
- The patient device rechargeable batteries that make an operating time of about 24 h possible. The...
- The service center compiles the messages into a comprehensive report (Cardio Report). This Cardio...
- Indications and Contraindications
- For the general indications and contraindications please refer to the Actros+ Family technical ma...
- Criteria for using Home Monitoring
- There are no contraindications for use of the Home Monitoring function. This function has no infl...
- • The patient can not handle the system as intended, because of their physical or psychological c...
- • 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 follow-up examination. When using the Home Mon...
- Caution: The data transmitted by Home Monitoring are not suitable for diagnosis, because not all ...
- Transmission of Message
- The Home Monitoring function can be switched ON or OFF with the programming device. If the Home M...
- The attending physician himself decides if the patient should trigger a transmission by programmi...
- The time and interval (Monitoring Interval) of the periodic message are programmable. For the per...
- Application of a magnet over the implant activates a transmission. The attending physician should...
- Diagnostic Memory Functions
- BA03 DDDR has the same standard functions as the ActrosDR+, with the exception that the Gain Mon...
- When the Home Monitoring function is activated, the following diagnostic memory functions are rec...
- The function Event Counter can record the following events:
- Event sequences:
- With every periodic message, the counter is reset.
- The VES events are classified according to their complexity. The following classifications are av...
- 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 ³ 120 bpm
- This function records data, that are characteristic for the activities of patient and pacemaker s...
- Functions of Home Monitoring
- The functions of Home Monitoring and their parameters can be set with the programmers EPR 1000pl...
- 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 monitorin...
- The patient activated message can also be programmed ON or OFF. This option is deactivated in the...
- Using the BA03 DDDR Pacemaker
- 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.
- In addition to the description in the SWM 1000/B-K00.0 manual, the following special features are...
- • 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 332 076
- Technical Data
- DDD, DDDR, DDI, DDIR
- DDD, DDDR, DDI, DDIR, DVI, DVIR, VDD, VDDR, DOO, DOOR, VVI, VVIR, AAI, AAIR, VOO, VOOR, AOO, AOOR...
- Off, On
- 1...(1) ...30 days
- 0:00...23:50 h:min
- Off, On
- 30 ... (1) ... 88 ... (2) ... 122 ... (3) ... 140 ... (5) ... 180 ppm
- Off; -5 ... (5) ... -50 bpm
- Off; 1 ... (1) ... 10
- Off; 1 ... (1) ... 10
- 100; 110; 120; 130; 140; 160; 185 ppm
- Off; (and basic rate settings)
- 2:1; WKB (automatic setting)
- 190 ... 220 ppm
- low; medium; high; individual; fixed
- 15; 50; 75; 100; 120 ... (10) ... 200; 225; 250; 300 ms (programmable in 5 ranges)
- 100 ms
- 12; 16; 24; 32; 40; 48; 56; 72 ms
- Auto; asynchronous; synchronous
- 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
- 0 ... (50) ... 350 ms
- Off; On (in the modes DDD(R) and VDD(R))
- unipolar; bipolar / unipolar; bipolar unipolar; bipolar / unipolar; bipolar
- 1 ... 40 (in 32 steps)
- Off; On
- very low; low; medium; high; very high
- 1; 2; 4; 8 ppm/s
- 80 ... (5) ... 180 ppm/s
- 0,1; 0,2; 0,4; 0,8 ppm/s
- programmed value decreased by 11% (in the modes DVI(R), DDI(R), DVT(R), DDI/T(R), decreases by 4,...
- Pulse generator behavior after reaching ERI
- programmed values
- programmed values
- 0 ...(1)...14 days
- 14 days
- Features
- • Home Monitoring
- • 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
- Default Programs
- Features
- Factory- Standard - Safe Settings Program Program
- Off Off Off
- DDD DDDR VVI
- Off Off —
- 60 ppm 60 ppm 70 ppm
- Off Off Off
- — — Off
- — — Off
- Off Off Off
- 160 ppm 160 ppm —
- medium medium —
- 24 ms 24 ms —
- Auto Auto Auto
- 3,6 V 3,6 V — 3,6 V 3,6 V 4,8 V
- 0,4 ms 0,4 ms — 0,4 ms 0,4 ms 1,0 ms
- 1,5 mV 1,5 mV — 2,5 mV 2,5 mV 2,5 mV
- 425 ms 425 ms — 250 ms 250 ms 300 ms
- 0 ms 0 ms —
- Factory Standard - Save Settings Program Program
- — medium —
- — 6 —
- — Off —
- — 2 ppm/s —
- — 120 ppm —
- — 0,4 ppm/s —
- unipolar unipolar unipolar
- unipolar unipolar unipolar
- standard standard standard
- Housing Titanium
- Grommet Silicone
- Connector Receptacle Epoxy resin
- Coating (for unipolar Silicone (if used)
- devices)
- EPR 1000 plus , and TMS 1000 plus
- Hybrid electronics with VLSI-CMOS-Chip
- 270 kW 330 kW
- biphasic, asymmetric
- cathodic
- 12 µA
- 24 µA
- 36 cm2
- flattened ellipsoidal
- Li/J
- Wilson Greatbatch
- WG 8431
- 2,8 V
- 2,5 V
- 1,3 Ah
- 6,7 years at pulse amplitudes 3,6 V
- 5,1 years at pulse amplitudes 3,6 V
- 0,13
- IS-1 (accepts unipolar and bipolar)
- 30 g
- 13 cm3
- 6 x 45 x 57 mm
- EE
- Data according to EN 50 061
- 60 ± 1 min-1
- 1000 ± 3 ms
- 1000 ± 5 ms
- 90 ± 1 min-1 (for 10 cycles)
- 664 ± 2 ms (for 10 cycles)
- 180 +3/-1 ms 180 +3/-1 ms 160 +15/-5 ms 140 +15/-5 ms 120 +15/-5 ms 100 +15/-5 ms
- Atrium Ventricle
- 3,6 +0,25 V/ -0,45 V 3,6 +0,25 V/ -0,45 V 3,3 +0,25 V / -0,45 V 3,3 +0,25 V / -0,45 V
- 0,43 ±0,02 ms 0,43 ±0,02 ms
- 1,5 ±0,5 mV 2,5 ±0,5 mV 1,8 ±0,5 mV 2,5 ±0,5 mV
- 425 +5 / -20 ms 250 +5 / -20 ms
- 210 ±20 min-1 210 ±20 min-1
- Lead Connection Order Number
- IS-1 122 126
Technical Data
18
Tolerances of Factory Settings
1)
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
90 ± 1 min
-1
(for 10 cycles)
Magnet Interval
664 ± 2 ms (for 10 cycles)
AV delay
Basic rate
≤
70 ppm
70-90 ppm
91-110 ppm
111-130 ppm
≥
130 ppm
180 +3/-1 ms
180 +3/-1 ms
160 +15/-5 ms
140 +15/-5 ms
120 +15/-5 ms
100 +15/-5 ms
Atrium Ventricle
Pulse amplitude
Peak value
EN 50061 mean
3,6 +0,25 V/ -0,45 V 3,6 +0,25 V/ -0,45 V
3,3 +0,25 V / -0,45 V 3,3 +0,25 V / -0,45 V
Pulse width
0,43 ±0,02 ms 0,43 ±0,02 ms
Sensitivity
15 ms sin
2
40 ms sin
2
EN 50061 Triangle
1,5 ±0,5 mV
2,5 ±0,5 mV
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
1) 37°C, 500 Ω