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
19
Order Information
Model
Lead Connection Order Number
BA03 DDDR
uncoated
IS-1 122 126
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., 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.