BIOTRONIK Philos DR-T Technical Manual
BIOTRONIK Philos DR-T Technical Manual

BIOTRONIK Philos DR-T Technical Manual

Dddr dual chamber pulse generator with home monitoring

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Philos DR-T
DDDR Dual Chamber Pulse Generator
with Home Monitoring
Technical Manual

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Summary of Contents for BIOTRONIK Philos DR-T

  • Page 1 Philos DR-T DDDR Dual Chamber Pulse Generator with Home Monitoring Technical Manual...
  • Page 2 [Reference ISO 5841-3:1992(E)]. AUTION 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.
  • Page 3: Table Of Contents

    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.
  • Page 4 Philos DR-T Technical Manual AUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician (or properly licensed practitioner).
  • Page 5: Home Monitoring-Overview

    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.
  • Page 6: Patient Device With Components

    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.
  • Page 7: Receiving Patient Data

    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.
  • Page 8 4 Philos DR-T Technical Manual Table 1: System Requirements / Recommendations System System Requirements Recommendations (for Optimal Usage) Screen 800 x 600 ≥ 1024 x 768 Resolution Internet 56 kB/sec ≥ 128 kB/sec Bandwidth (DSL, cable modem) 600 MHz, 128...
  • Page 9: Indications And Contraindications

    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.
  • Page 10 6 Philos DR-T Technical Manual...
  • Page 11: Warnings And Precautions

    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...
  • Page 12 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.
  • Page 13 Philos DR-T Technical Manual 9 Consult the Philos manual for additional warnings and precautions associated with this device.
  • Page 14 10 Philos DR-T Technical Manual...
  • Page 15: Types Of Messages

    Philos DR-T Technical Manual 11 4. Types of Messages When Home Monitoring function activated, 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 •...
  • Page 16 Home Monitoring data are no longer possible. The attending physician must notify the BIOTRONIK Service Center about which of these events he/she wishes to be informed. 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.
  • Page 17: Trend Message

    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...
  • Page 18 14 Philos DR-T Technical Manual...
  • Page 19: Description Of Transmitted Data

    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.
  • Page 20: Av Conduction

    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 •...
  • Page 21: Technical 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,...
  • Page 22: Pulse And Control Parameters

    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;...
  • Page 23 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;...
  • Page 24 20 Philos DR-T Technical Manual Sensitivity 0.1...(0.1)...1.0...(0.1)…1.5…(0.5)...7.5 mV 0.5...(0.5)...2.5...(0.5)...7.5 mV Refractory period 200...(25)…425...(25)...775 ms 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;...
  • Page 25: Rate Adaptation

    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,...
  • Page 26 22 Philos DR-T Technical Manual Magnet Mode Cycles 1-10 after After Cycle 10 magnet application Automatic Asynchronous, Synchronized with basic rate at 80 ppm basic rate reduced by 4.5 - 11% Asynchronous Asynchronous, Asynchronous with basic rate at 80 ppm...
  • Page 27: Additional Functions

    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 • (pulse...
  • Page 28: Programmers

    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...
  • Page 29: Mechanical Data

    Philos DR-T Technical Manual 25 Polarity cathodic Power Consumption BOS, inhibited: 14 µA BOS, 100 % pacing: 22 µA Conducting Surface uncoated: 32.8 cm coated: 7.23 cm Conducting Shape uncoated: flattened ellipsoidal coated: ellipsoidal AT T E R Y Power Source...
  • Page 30 26 Philos DR-T Technical Manual Volume 12 cm Dimensions 6 x 44 x 51 mm X-Ray Identification...
  • Page 31: Order Information

    Philos DR-T Technical Manual 27 7. Order Information Product Name Order Number Philos DR-T 331 440...
  • Page 32 Distributed by: BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) (503) 635-9936 (FAX) Manufactured by: BIOTRONIK GmbH & Co. KG Woermannkehre 1 D-12359 Berlin Germany M4064-C 7/04...

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