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

Philos DR-T Technical Manual 7

3. Warnings and Precautions

Certain therapeutic and diagnostic procedures may cause
undetected damage to a pulse generator, resulting in
malfunction or failure at a later time. Please note the following
warnings and precautions:

Magnetic Resonance Imaging (MRI) – Avoid use of magnetic
resonance imaging as it has been shown to cause movement of
the pulse generator within the subcutaneous pocket and may
cause pain and injury to the patient and damage to the pulse
generator. If the procedure must be used, constant monitoring is
recommended, including monitoring the peripheral pulse.

Rate-Adaptive Pacing – Use rate-adaptive pacing with care in
patients unable to tolerate increased pacing rates.

High Output Settings – High output settings combined with
extremely low lead impedance may reduce the life expectancy of
the pulse generator to less than 1 year. Programming of pulse
amplitudes, higher than 4.8 V, in combination with long pulse
widths and/or high pacing rates may lead to premature activation
of the replacement indicator.

3.1 Home Monitoring

Patient’s Ability – Use of Home Monitoring requires the patient

and/or caregiver to follow the system instructions and cooperate
fully when transmitting data.

If the patient cannot understand or follow the instructions
because of physical or mental challenges, another adult who can
follow the instructions will be necessary for proper transmission.

Cellular Phone Availability – Home Monitoring is not practical
for patients who live in areas where cellular telephone networks,
utilizing the GSM standard, are not available or are not likely to
become available in the near future.

8 Philos DR-T Technical Manual

Electromagnetic Interference (EMI) – Precautions for EMI

interference with the Philos DR-T pulse generator are provided

in the Philos technical manual in section 4.5. Sources of EMI

including cellular telephones, electronic article surveillance
systems, and others are discussed therein.

Use in Cellular Phone Restricted Areas – The mobile patient
device (transmitter/receiver) should not be utilized in areas
where cellular phones are restricted or prohibited (i.e.,
commercial aircraft).

Event Triggered Message – A timely receipt of the
corresponding event report cannot be guaranteed. The receipt
is also dependent on whether the patient was physically situated
in the required coverage range of the patient device at the time
the event information was sent.

Patient-Activated Message – The magnet effect must be
programmed “synchronous” if the [Patient Message] function is
activated. Otherwise, this function will not be available.

Not for Diagnosis – The data transmitted by Home Monitoring
are not suitable for diagnosis, because not all information
available in the implant is being transmitted.

Follow-Ups – When using Home Monitoring, the time period
between follow-up visits may not be extended.

The use of Home Monitoring does not replace regular follow-up
examinations. The data transmitted via Home Monitoring are not
suitable for a conclusive diagnosis.

Magnet Effect – The magnet effect must be programmed
“synchronous” if the attending physician enables the patient to
transmit messages.

Lead Connection – 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)].

Philos DR-T Technical Manual 9

Consult the Philos manual for additional warnings and
precautions associated with this device.

10 Philos DR-T Technical Manual Philos DR-T Technical Manual 11

4. Types of Messages

When the Home Monitoring function is activated, the
transmission of a message from the implant can be triggered as
follows:

• Trend Message – the time period (daily) initiates the
report

• Event Message – the pacemaker detects certain events,
which initiate a message immediately

• Patient Message – the patient initiates transmission of a
message

The attending physician decides whether or not the patient will
be able to initiate the transmission of a message on their own
through application of a magnet. Transmissions initiated through
magnet application do not affect event or trend message
transmissions.

4.1 Event Message

When certain cardiac and technical events are detected by the
implant, a message transmission is automatically triggered. This
is described as an “event message”.

12 Philos DR-T Technical Manual

The following cardiac and technical events initiate a report:

• Atrial Lead Check < 300 and > 3000 Ohm

• Ventricular Lead Check < 300 and > 3000 Ohm

• Ventricular Bursts (Runs)

• Ventricular Events (Episodes)

• Low P-Wave Amplitude

• Low R-Wave Amplitude

1

(< 50% safety margin)

1

(< 50% safety margin)

• ERI Activation

st

• 1

Mode Switch/24 hours

WARNING

A timely receipt of the corresponding event report cannot be
guaranteed. The receipt is also dependent on whether the
patient was physically situated in the required coverage
range of the patient device at the time the event information
was sent.

NOTE:

When ERI mode is reached, this status is transmitted.
Further measurements and transmissions of Home
Monitoring data are no longer possible.

NOTE:

The attending physician must notify the BIOTRONIK Service
Center about which of these events he/she wishes to be
informed.

1

Examples: The programmed sensitivity is 1.0 mV.
A) Average of the measured P/R-Wave amplitudes is 2.6 mV. Therefore,
measured value is greater than 100% of the safety margin. Event message is
not triggered.
B) Average of the measured P/R-Wave amplitudes is 1.9 mV. Therefore,
measured value is less than 100%, but greater than 50% of the safety margin.
Event message is not triggered.
C) Average of the measured P/R-Wave amplitudes is 1.4 mV. Therefore,
measured value is smaller than 50% of the safety margin. As a result, an event
message is triggered.

Philos DR-T Technical Manual 13

4.2 Trend Message

An additional type of message is the programmable “Trend
Message”. Trend messages occur at a programmable time of
transmission (i.e., at the end of the Monitoring Interval). The
time can be set anywhere between 0:00 and 23:50 hours. It is
recommended that you select a time during the late night or
early morning hours (between 0:00 and 4:00), or other time
when the patient is usually in his or her home.

The length of the time interval (monitoring interval) is not
programmable – it is preset to “daily”.

4.3 Patient Message

It is possible to trigger a transmission through magnet
application over the pacemaker. The attending physician must
inform the patient in detail about operating the device and about
the physical symptoms which would warrant a magnet
application by the patient.

WARNING

The magnet effect must be programmed “synchronous” if
the [Patient Message] function is activated. Otherwise, this
function will not be available.

14 Philos DR-T Technical Manual Philos DR-T Technical Manual 15

5. Description of Transmitted

Data

The following data are transmitted by Home Monitoring, when
activated. In addition to the medical data, the serial number of
the implant is also transmitted.

5.1 The Monitoring Interval

The monitoring interval is considered the time period since the
last trend message was transmitted. For a trend message, the
monitoring interval since the previous trend message is set at
24 hours. For an event or patient message, the monitoring
interval would typically be less than 24 hours. This occurs when
these messages are sent after the programmed transmission
time of the trend message.

5.2 Heart Rate

• Average (mean) ventricular heart rate (bpm)

5.3 Atrial Rhythm

• Intrinsic rhythm (As / Ax) (%)

• Number of Mode Switching

• Duration of Mode Switching (%)

5.4 Ventricular Rhythm

• Intrinsic rhythm (Vs/ Vx) (%)

• Ventricular rate at Mode Switching (bpm)

• Number of ventricular runs (4...8 sequential VES)

• Number of ventricular events (more than 8 sequential

VES), defined as a ventricular episode

• Duration of the longest ventricular event (sec)

16 Philos DR-T Technical Manual

5.5 AV Conduction

• AV Synchronicity (Ax Vx/Vx) (%)

− with intrinsic rhythm (AsVs) (%)

− with atrial stimulation (ApVs) (%)

− with ventricular stimulation (AsVp) (%)

− with dual-chamber stimulation (ApVp) (%)

5.6 System Status

• Atrial lead check

• Ventricular lead check

• Mean P-Wave amplitude / programmed sensitivity (%)

• Mean R-Wave amplitude / programmed sensitivity (%)

• Battery status

NOTE:

Atrial and Ventricular Lead Check must be programmed ON
to enable Home Monitoring functionality of this data.

Philos DR-T Technical Manual 17

6. Technical Data

6.1 Modes

The following modes are available in the Philos DR-T when
Home Monitoring is deactivated:

DDDR, DDTR/A, DDTR/V, DDTR, DDIR, DDIR/T, DVIR, DVTR,
DOOR, VDDR, VDTR, VDIR, VVIR, VVTR, VOOR, AAIR, AATR,
AOOR, DDD, DDT/A, DDT/V, DDT, DDI, DDI/T, DVI, DVT, DOO,
VDD, VDT, VDI, VVI, VVT, VOO, AAI, AAT, AOO, OFF

The Home Monitoring function is available for the following
pacing modes:

DDDR, DDTR/A, DDTR/V, DDTR, DDIR, DDIR/T, VDDR, VDTR,
VDIR, DDD, DDT/A, DDT/V, DDT, DDI, DDI/T, VDD, VDT, VDI

NOTE:

Bold parameters indicate factory settings.

6.2 Home Monitoring Parameters

Home Monitoring

Off, On

Monitoring Interval

1 day

Time of Transmission

0:00...(10)...23:50 hours

Patient Message

Off, On

Event Message

Off, On

18 Philos DR-T Technical Manual

6.3 Pulse and Control Parameters

Basic rate

30...(1)...60...(1)...88...(2)...122...(3)...140...(5)...180 ppm

Night rate

Off, 30...(1)...60...(1)...88...(2)...122...(3)...140...(5)...180 ppm

Rate Hysteresis

Off; -5...(5)...-50 bpm

Repetitive Hysteresis

Off; 1…(1)…10

Scan Hysteresis

Off: 1…(1)…10

Upper Tracking Rate (UTR)

100; 110; 120; 130; 140; 160; 185 ppm

UTR Response

2:1; WRL (automatic selection)

2,3,4

Rate Limitation

190…220 ppm

Dynamic AV Delay (Dual chamber only)

low; medium; high; individual; fixed

AV Delay Values (Dual chamber only)

15; 50; 75; 100; 120...(10)...200; 225; 250; 300 ms

(Programmable in 5 ranges)

2

The corresponding intervals t correlate with the rates f by the formula t = 60.000
/ f (t in ms, f in ppm).

3

In the event of electronic defect.

4

Rate Limitation changes as the Pacemaker approaches End of Service. The
Rate Limitation is nominally 190 ppm at Beginning of Service (BOS) and can
reach 220 ppm at End of Service (EOS) due to battery depletion.

Philos DR-T Technical Manual 19

AV Hysteresis

Off; low; medium; high

AV Repetitive Hysteresis

Off; 1...(1)...6

AV Scan Hysteresis

Off; 1...(1)...6

AV safety delay (Dual chamber only)

100 ms

Sense Compensation

Off; -15...(15)...-120 ms

Ventricular Blanking Time

16; 24; 32; 40; 48; 56; 72 ms

Magnet effect

Automatic; asynchronous; synchronous

Asynchronous Magnet Effect: paces at 90 ppm.

Automatic Magnet Effect; 10 cycles at 90 ppm
asynchronous; thereafter synchronous with the programmed
basic rate

Synchronous Magnet Effect; synchronous with programmed
basic rate

Pulse amplitude

A 0.1...(0.1)...3.6...(0.1)...4.8...(1.2)...8.4 V

V 0.1...(0.1)...3.6...(0.1)...4.8...(1.2)...8.4 V

Ventricular Pulse Amplitude for Safe Program

4.8V

Pulse width

A 0.1; 0.2; 0.3; 0.4; 0.5; 0.75; 1.0; 1.5 ms

V 0.1; 0.2; 0.3; 0.4; 0.5; 0.75; 1.0; 1.5 ms

20 Philos DR-T Technical Manual

Sensitivity

A 0.1...(0.1)...1.0...(0.1)…1.5…(0.5)...7.5 mV

V 0.5...(0.5)...2.5...(0.5)...7.5 mV

5

Refractory period

A 200...(25)…425...(25)...775 ms

V 170, 195, 220, 250; 300; 350; 400 ms

PVARP (minimum)

Off, dependent on TARP and AV Delay settings

ARP Extension

0...(50)...350 ms

Lead Check

Off; On

Automatic Mode Conversion

Off; On (in modes DDD(R), DDT(R)/A, DDT(R)/V, and VDD(R))

Mode Switch (X out of Y)

Off; On (in modes DDD(R), DDT(R)/A, DDT(R)/V and VDD(R))

X = 3...(1)...8

Z = 3...(1)...8

Lead Polarity

Pace: A unipolar; bipolar

V unipolar; bipolar

Sense: A unipolar; bipolar

V unipolar; bipolar

Far-Field Blanking

50...(25)...200 ms

5

In the DDIR, VVIR and VOOR modes, lower maximum sensor rates result than indicated

here (partly depending on the selected AV interval). The correct values are indicated by
the programmer.

Philos DR-T Technical Manual 21

PMT Management

Off; On

6.3.1 Rate Adaptation

Sensor gain

1.0, 1.1, 1.3, 1.4, 1.6, 1.8, 2.0, 2.2, 2.6, 3.0, 3.3, 3.7, 4.0, 4.5,

5.0, 6.0, 7.0, 8.0, 8.5, 10, 11, 12, 14, 16, 18, 20, 22, 24, 28, 32,
35, 40

Sensor threshold

very low; low; mean; high; very high

Rate increase

1, 2, 4, 8 ppm/s

Maximum sensor rate

80...(5)...180 ppm

Rate decrease

0.1, 0.2, 0.4, 0.8 ppm/s

Automatic Sensor Gain

Off; On

6.3.2 Parameters at Replacement Indication

Basic Rate

Programmed value minus 11%

(in modes DVI(R), DDI(R), DVT(R), DDI/T(R) minus 4.5–11%,
depending on programmed AV Delay)

Magnet Rate

The magnet rate in all modes decreases as shown in the
following table.

22 Philos DR-T Technical Manual

Magnet Mode Cycles 1-10 after

magnet

application

Automatic Asynchronous,

basic rate at 80 ppm

Asynchronous Asynchronous,

basic rate at 80 ppm

Synchronous Synchronized with

basic rate reduced

by 4.5 - 11%

Pulse Widths

Programmed values

Sensitivities

Programmed values

After Cycle 10

Synchronized with
basic rate reduced

by 4.5 - 11%

Asynchronous with

basic rate at 80

Synchronized with
basic rate reduced

by 4.5 - 11%

Philos DR-T Technical Manual 23

6.3.3 Additional Functions

Home Monitoring

Additional functions conform with Philos DR:

• Temporary Program Activation

• High Precision Threshold test in the range of 0.1 up to

4.8 V with 0.1 V resolution

• PAC (pulse amplitude control) system produces
consistent pulses

• Analog Telemetry with measuring of battery, pulse and
lead data

• Two channel Real Time IEGM Transmission with
markers

• Patient Data Memory

• Sensor Simulation

• Position Indicator for the programmer head

• 24 hour Trend

• Heart Rate Histogram

• Sensor Rate Histogram

• Sensor Test Trend with complete Rate Forecast

• Automatic Sensor Gain with Trend Monitor

• VES Analysis

• AES Analysis

• Retrograde Conduction Test

• Automatic Mode Conversion

• Mode Switching

• PMT Management

• Activity Report

• Event counter

• P-/R-wave Tests with Trend Data

• External Pulse Control up to 800 ppm

• Night Program

24 Philos DR-T Technical Manual

• Arrhythmia Detection Recordings (note that only 3 ADRs
can be stored by the Philos DR-T; however, 10 can be
stored by the Philos DR)

• Lead Impedance Trends

• Lead Check

6.4 Programmers

Home Monitoring functions and their parameters can be
configured with the following programming devices:

EPR 1000

PLUS

, TMS 1000

PLUS

6.5 Materials in Contact with Human
Tissue

Housing: Titanium

Connector receptacle: Epoxy resin

Sealing Plugs: Silicone Rubber

Coating for unipolar devices: Silicone Rubber

6.6 Electrical Data/Battery

N

OTE:

At 37ºC, with pacing impedance of 500 Ohms.

LECTRICAL DATA

E

Circuit

Hybrid electronics with VLSI CMOS Chip

Input Impedance

A 240 kOhm

V 240 kOhm

Pulse Form

biphasic, asymmetric

Philos DR-T Technical Manual 25

Polarity

cathodic

Power Consumption

BOS, inhibited: 14 µA

BOS, 100 % pacing: 22 µA

Conducting Surface

2

uncoated: 32.8 cm

coated: 7.23 cm

2

Conducting Shape

uncoated: flattened ellipsoidal

coated: ellipsoidal

BATTERY

Power Source

Li/I

Open-Circuit Voltage

2.8 V

Voltage at ERI

2.5 V

6

Nominal Capacity

1.3 Ah

6.7 Mechanical Data

Lead Connector

IS-1 (accepts unipolar and bipolar)

Weight

27 g

6

Battery manufacturer’s specification.

26 Philos DR-T Technical Manual

Volume

3

12 cm

Dimensions

6 x 44 x 51 mm

X-Ray Identification

VV

Philos DR-T Technical Manual 27

7. Order Information

Product Name Order Number

Philos DR-T 331 440

Distributed by:

BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035-5369
[phone] (24-hour)
[phone] (FAX)

M4064-C 7/04

Manufactured by:

BIOTRONIK GmbH & Co. KG

Woermannkehre 1

D-12359 Berlin Germany