Biotronik BA0T User Manual
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
➤
K00.0 manual for a description of Actros DR features
In addition to the descript ion in the SW M 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.
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1
or the SWM 1000/B-
• 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 softw are can be ordered by using th e following Catalog No.:
SWM 1000 /B- K T0.0.A 332 076
Note: Th is sof tw are c an onl y be used with the BIOT RONIK
program m ers EPR 100 0
Plus
and TMS 1000
Plus
.
Home Monitoring - Introduction
Home Monitoring - Introduction
2
Home Monitoring
Transmission
of message
The pacemaker BA03 DDDR is the newest member of
the Actros
treatment of bradycardia arrhythmia. The pacemaker
is identical to the Actros DR
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family, that consists of pacemakers for
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in that it is a rate adapt ive,
dual chamb er sy stem with se parat e atr ial and ventr ic ular 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
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.
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 o ver the implant .
Patient device
with components
The patient device (Fig.1) is developed for home use
and consists of a mobile unit and the r espective charging station. The patient can also carry the mobile unit
with them in their normal daily activi ties .
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-
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Home Monitoring - Introduction
Fig.1
Patient Device with
Charging Station
RUC 200
wards them to a
BIOTRONIK Service Center via
mobile communications.
Cardio Report
The service cent er c ompiles the mes sages int o 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 technci a l m a nu a .
• The additional Home Monitoring functions of the
BA03 DDDR are found in this manual
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Indications and Contraindications
Indications and Contraindications
4
For the general indications and contraindications
please refer to the Actros
Basically, the indications and contraindications of the
BA03 DDDR are identical to that for the rate adaptive
dual chamber pacemaker Actros DR
teria for the Home Monitoring Function are described
as follows:
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Family tech nical manu al.
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 i s 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.
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. The special cri-
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 prolonged.
Caution:
The da ta tran smitte d by Ho me Mo n itoring are not
suitable for diagnosis, because not all information
avail able i n the implant is being transmitte d .
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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 Mon-
itoring f u nc tio n is only poss ibl e in fol l ow ing 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 transmissi on
is act ivate d.
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 applicatio n by the
patien t.
Caution:
The magnet effect must be programmed "synchronous" if the attending physician enables the patient to
transmit messages.
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