BIOTRONIK Philos DR-T Technical Manual
Philos DR-T
DDDR Dual Chamber Pulse Generator
with Home Monitoring
Technical Manual
Philos DR-T
Implantable Pulse Generator
Philos DR-T
X-Ray identification
Radiopaque Identification
A radiopaque identification code is visible on standard x-ray, and
identifies the pulse generator:
Philos DR-T
VV
CAUTION
Because of the numerous available 3.2-mm configurations
(e.g., the IS-1 and VS-1 standards), lead/pulse generator
compatibility should be confirmed with the pulse generator
and/or lead manufacturer prior to the implantation of a pacing
system.
IS-1, wherever stated in this manual, refers to the
international standard, whereby leads and generators from
different manufacturers are assured a basic fit. [Reference
ISO 5841-3:1992(E)].
CAUTION
Federal (U.S.A.) law restricts this device to sale by or on the
order of, a physician (or properly licensed practitioner).
©2004 BIOTRONIK, Inc., all rights reserved.
Philos DR-T Technical Manual i
Contents
1. Home Monitoring-Overview ................................................1
1.1 Home Monitoring ..............................................................1
1.2 Transmission of Information .............................................1
1.3 Patient Device with Components......................................2
1.4 Receiving Patient Data .....................................................3
2. Indications and Contraindications.....................................5
3. Warnings and Precautions..................................................7
3.1 Home Monitoring ..............................................................7
4. Types of Messages ............................................................11
4.1 Event Message ............................................................... 11
4.2 Trend Message...............................................................13
4.3 Patient Message .............................................................13
5. Description of Transmitted Data.......................................15
5.1 The Monitoring Interval ...................................................15
5.2 Heart Rate.......................................................................15
5.3 Atrial Rhythm ..................................................................15
5.4 Ventricular Rhythm .........................................................15
5.5 AV Conduction ................................................................16
5.6 System Status.................................................................16
6. Technical Data ....................................................................17
6.1 Modes .............................................................................17
6.2 Home Monitoring Parameters.........................................17
6.3 Pulse and Control Parameters .......................................18
6.3.1 Rate Adaptation ......................................................21
6.3.2 Parameters at Replacement Indication ..................21
6.3.3 Additional Functions................................................23
6.4 Programmers ..................................................................24
6.5 Materials in Contact with Human Tissue ........................24
6.6 Electrical Data/Battery ....................................................24
6.7 Mechanical Data .............................................................25
7. Order Information ..............................................................27
ii Philos DR-T Technical Manual
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the
order of, a physician (or properly licensed practitioner).
Philos DR-T Technical Manual 1
1. Home Monitoring-Overview
Philos DR-T offers the complete functionality of a DDDR
pacemaker while being equipped with the additional features
associated with Home Monitoring. Consult the Philos technical
manual for a description and overview of the standard
pacemaker functionality of the Philos DR-T.
1.1 Home Monitoring
Home Monitoring is a novel system, which enables the exchange
of information about a patient’s cardiac status between implant,
patient, and physician. Home Monitoring can be used to provide
the physician with advance reports from the implant and process
them into graphical and tabular formats. This information helps
the physician optimize the therapy process, as it may result in
the patient being scheduled for additional clinical appointments
between regular follow-up visits if necessary.
The implant’s Home Monitoring function can be used for the
entire operational life of the implant (prior to ERI) or for shorter
periods, such as several weeks or months.
1.2 Transmission of Information
The implant transmits information with a small transmitter, which
has a range of about 2 meters. The patient’s implant data are
sent daily to the corresponding patient device (i.e.,
CardioMessenger) at a configurable time. The transmissions
may also be activated by the patient with the application of a
magnet over the implant and by certain cardiac events, as
programmed. The types of transmissions are discussed in
Section 4
The minimal distance between the implant and the patient device
must be 15 cm.
.
2 Philos DR-T Technical Manual
1.3 Patient Device with Components
The patient device (Figure 1) is designed for use in the home
and is comprised of the mobile device and the associated
charging station. The patient can carry the mobile device with
them during his or her occupational and leisure activities. The
patient device comes with a rechargeable battery that has an
approximate operational time of 24 hours after a charge time of 5
hours. It receives information from the implant and forwards it
via the mobile network to a BIOTRONIK Service Center.
For additional information about the patient device, please refer
to its manual.
Figure 1: Patient Device with Charging Stand
(CardioMessenger)
Philos DR-T Technical Manual 3
1.4 Receiving Patient Data
The implant’s information is digitally formatted by the
BIOTRONIK Service Center and processed into a concise report
called a Cardio Report. The Cardio Report, which is adjusted to
the individual needs of the patient, contains current and previous
implant data. The Cardio Report is sent to the attending
physician via fax or is available on the Internet, which is selected
during registration of the patient. For more information on
registering for Home Monitoring, contact your BIOTRONIK sales
representative.
The password protected BIOTRONIK Home Monitoring website
can be accessed by registered users at the following URL:
www.biotronik-homemonitoring.com
An online help menu is available in order to assist with the use of
the Home Monitoring website.
Use of the Internet for reviewing Home Monitoring data must be
in conjunction with the system requirements listed in Table 1
Additionally, Table 1
recommended for optimizing usage of the Internet.
provides system specifications that are
.
4 Philos DR-T Technical Manual
Table 1: System Requirements / Recommendations
System
Requirements
System
Recommendations
(for Optimal Usage)
Screen
800 x 600 ≥ 1024 x 768
Resolution
Internet
Bandwidth
PC 600 MHz, 128
56 kB/sec ≥ 128 kB/sec
(DSL, cable modem)
N/A
MB RAM
Internet Browser MS Internet
Explorer 5.0
- or Netscape
≥ MS Internet Explorer
5.5
- or ≥ Netscape 7/Mozilla
Navigator 4.72
Acrobat Reader Version 4 Version 5 or higher
Communication
Channel
Fax (G3) or
e-mail
Fax (G3), e-mail or
mobile phone
Additionally, the attending physician may register to be informed
of the occurrence of an Event Triggered Message through email
or SMS (i.e., mobile phone) with a brief text message. If
registered for Internet availability, the patient’s detailed implant
data can then be viewed by logging onto the Home Monitoring
website.
Philos DR-T Technical Manual 5
2. Indications and
Contraindications
For the general indications and contraindications, please refer to
the Philos Family technical manual. The indications and
contraindications of the Philos DR-T are identical to those of the
rate adaptive dual chamber Philos DR pulse generator.
6 Philos DR-T Technical Manual
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