BIOTRONIK Reliaty User Manual
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BIOTRONIK Reliaty User Manual

BIOTRONIK Reliaty User Manual

Pacing system analyzer
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Reliaty
Pacing System Analyzer
Cardiac Rhythm Management
External Devices
User's Guide

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Summary of Contents for BIOTRONIK Reliaty

  • Page 1 Cardiac Rhythm Management External Devices User's Guide Reliaty Pacing System Analyzer...

  • Page 3: Table Of Contents

    Table of Contents Indications/Contraindications/Warnings/Precautions/ General Safety Instructions ..............3 Overview ....................18 System Overview ................. 19 Starting Reliaty ................... 20 Connecting to Reliaty................22 External Monitor ..................22 Patient Cables ..................23 User Interface ..................24 Buttons ....................24 Graphical Interface ................. 26 Channel Selection ..................

  • Page 5: Indications/Contraindications/Warnings/Precautions/General Safety Instructions

    (DFT). Intended Use The Reliaty is intended to be used during the implantation of pacemakers and defibrillators to evaluate the placement and integrity of pacing leads and to determine the appropriate pacing parameters for the implanted device.
  • Page 6 Indications and Contraindications for Use • For the sensing of intrinsic events of the heart: - P/R wave amplitudes and slew rate - Rates (PP, RR interval) - Intrinsic AV delay (PR interval) - Conduction times - Wenckebach point - VV delay • For the pacing of the heart: - Pacing threshold in up to 3 chambers - Lead impedances...
  • Page 7 Indications and Contraindications for Use Possible Complications Depending on the patient's condition and depending on the scope and type of pacing program, the following possible complications associated with the use of pacing system analyzers are reported in medical references: life-threatening atrial and ventricular arrhythmia, bradycardia, tachycardia, and asystole.
  • Page 8 Indications and Contraindications for Use Danger of explosion if exposed to cleaning and disinfecting agents Before operating the device, let cleaning and disinfection agents evaporate. Danger from contamination The device cannot be sterilized. • Do not allow the device to enter a sterile area. Danger from loss of pacing support After the device is switched on, the pacing functions are switched off for approximately 15 seconds while a self-test is...
  • Page 9 Indications and Contraindications for Use in the patient’s heart. • Do not touch the metal clips on the patient cable or the pacing lead. Electrical currents can be dangerous to the patient. • Discharge any electrical static charge on your person before touching the patient, the patient cables or the device.
  • Page 10 Indications and Contraindications for Use • Whenever possible disconnect the device from the patient when defibrillating. • If the device is connected to the patient during defibrillation, check its operations afterwards. Danger from HF surgery The device is equipped with protective circuitry to prevent damage when used with HF surgery.
  • Page 11 • Do not use the device if there is apparent damage. • If damage has occurred, contact BIOTRONIK to test, and if necessary, repair the device. Danger from unauthorized modification of the equipment Modification of the device or its accessories may place the health and safety of the operator and/or patient at risk.
  • Page 12 Indications and Contraindications for Use the user, or others, as well as the equipment. Note: Failure to observe the safety precautions voids all damage claims and manufacturer liability. The following dangers may arise in the event of improper use: • Failure of important device functions. • Personal endangerment due to electrical effects.
  • Page 13 Indications and Contraindications for Use the metal clips on the patient cable or the pacing lead may expose the patient's heart to dangerous electrical currents. Connecting cables to leads Verify that RV patient cable is connected to the RV lead before selecting cross-chamber LV pacing polarities.
  • Page 14 Indications and Contraindications for Use the corresponding leads, the electrostatic potential between physician or medical technicians and the patient must be equalized, for instance by touching the patient at a point as far as possible from the leads. Leakage currents Avoid leakage currents between all connected devices, the patient cable, and the patient if line-powered devices are used in the vicinity of the patient.
  • Page 15 Indications and Contraindications for Use Pacing mode selection Select a pacing mode that is consistent with the patient cable connections to the leads. Loss of pacing may be a consequence of inconsistent selection and may cause life- threatening danger to the patient. Wenckebach test Because atrial single chamber pacing is contraindicated for use in patients with no AV conduction, the Wenckebach test...
  • Page 16 A sensitivity setting at or above 1 mV is strongly recommended, if clinically suitable. Replacement parts and accessories Ensure safety compliance by using only original replacement parts and accessories authorized by BIOTRONIK. Using any other parts voids the liability for subsequent events, the guarantee, and the warranty. Defects...
  • Page 17 Indications and Contraindications for Use Installation site The device may only be operated in an environment that meets the following conditions: • The ambient temperature, relative humidity and atmospheric pressure are within the specified operating conditions. • Sterile operating conditions can be maintained. • There are no explosive gases in the vicinity of the device.
  • Page 18 Indications and Contraindications for Use Note: Before connecting the patient cable to the leads, ensure that the leads are securely implanted in the patient’s heart. • Patient cables may only be used by healthcare professionals that are qualified for intracardial examinations and therapy.
  • Page 19 Note: • Portable and mobile RF communication equipment can affect the operation of the device. • Use of accessories that are not approved by BIOTRONIK can increase the device’s electromagnetic emissions and/ or electromagnetic susceptibility. Note: Electromagnetic interference may cause noise...

  • Page 20: Overview

    The user controls the operations of Reliaty through the LCD touch-screen, parameter wheel, and control buttons. Figures 1 and 2 provide an overview of external features. The device provides three-chamber pacing and sensing and can display up to three channels of real-time IEGMs and markers.

  • Page 21: System Overview

    System Overview System Overview Connectors for patient cables Secondary power Tilt stand USB port VGA interface AC power Figure 1: Reliaty PSA Safe program LED indicators Measurement keys Maximum stimulation Preferred settings Parameter wheel Figure 2: Reliaty PSA front panel...

  • Page 22: Starting Reliaty

    Check battery cartridges and power supply before turning the device on. The ON/OFF button is located on the right side of the device. Press the ON/OFF button to turn on Reliaty. The start screen appears shortly after the device is turned on. A self-test then runs for approximately 15 seconds.
  • Page 23 Starting Reliaty Periodic Inspection • A complete inspection of the device needs to be performed: - in suspicion of malfunction; - every two years. • Excessive electrical power, e.g. combined use of HF surgery equipment or a defibrillator on a patient during use of the pacing system analyzer, may damage the device.

  • Page 24: Connecting To Reliaty

    Connect the VGA plug of the monitor to the VGA port, as shown in Figure 3. If the VGA port is set to Auto and Reliaty detects a connection to a VGA monitor, Reliaty will enable its external VGA port. The device may not detect some VGA monitors, so it may be necessary to manually enable the external port.

  • Page 25: Patient Cables

    LV leads of the patient. Remove the cables • Disconnect the patient cable or adapter from the pacing lead by opening the clips and removing the pacing lead. • Disconnect the patient cable from Reliaty by pulling on the cable’s locking connector.

  • Page 26: User Interface

    User Interface User Interface Buttons Figure 5: User interface and buttons LEDs : The LEDs, shown in Figure 5, along the top of the front panel indicate pacing or sensing in each of the three chambers. See Visual and Audio Signals section on page 43 for more information.
  • Page 27 User Interface Parameter wheel : To adjust a selected parameter, turn the wheel to the right or left. The new values are effective immediately. To increment the value, turn the wheel clockwise. To decrement the value, turn the wheel counter-clockwise. Max Stim: This button delivers pacing at 10 V at 2.0 ms.

  • Page 28: Graphical Interface

    User Interface Graphical Interface Figure 6: User interface Information bar : Along the top of the screen, the current mode, rate in each channel, and power supply indicator are displayed to provide basic information. Modes : Pressing the Mode button opens a drop down menu with common single- and dual-chamber modes.
  • Page 29 User Interface Pacing button : Pressing the Pace button, available in each chamber, toggles to ON or OFF to adjust the mode to enable or disable pacing in a particular chamber. Like the Sense button, the Pace button indicates whether pacing is ON or OFF in a particular channel using a filled in or empty circle.
  • Page 30 User Interface Basic rate : Selecting the Rate button will allow the user to increase or decrease the basic rate by adjusting the parameter wheel. The Rate button is indicated by the orange rectangle in Figure 6. Amplitude and pulse width : Selecting the Amplitude or Pulse Width buttons, available in each chamber, allows the user to adjust the output by adjusting the parameter wheel.

  • Page 31: Channel Selection

    Channel Selection Figure 7: Selecting a Channel Reliaty is capable of testing in three channels: atrium, right ventricle, and left ventricle. Each channel can be inactive, active, or selected. Inactive : The channel is not being tested and is not used in the current mode.

  • Page 32: Testing

    Tests button, located along the bottom of the Reliaty screen. Sensing Figure 8: P/R wave amplitude measurements in Reliaty P/R wave amplitude measurements are used to assess the ability of the implanted device to sense the intrinsic activity of the heart at the current lead position within the heart.

  • Page 33: Threshold And Impedance

    • Repeat the procedure for other channels as necessary. Threshold Impedance Figure 9: Threshold and impedance measurements in Reliaty Pacing threshold measurements are used to assess the ability of the implanted device to effectively and efficiently pace the heart at the current lead position. Lead impedance measurements are used in assessing the integrity of the lead and the connection of the lead’s electrodes with the...

  • Page 34: Conduction And Wenckebach

    Testing • Press the Channel button to activate and select the desired channel. • Press the Pace button to adjust the mode to allow pacing in that channel. • Adjust the rate and/or AV delay to force pacing in that channel. • Use the parameter wheel to decrease the pacing amplitude until loss of capture occurs.
  • Page 35 Testing Conduction Conduction measurements are used to determine appropriate pacing parameters for the implanted device. Antegrade conduction time is measured by sensing in the ventricle and measuring from atrial event to ventricular sensed event. The retrograde conduction time is measured by pacing in the ventricles and measuring the time interval between the ventricular pace and any subsequently induced P-wave.

  • Page 36: Burst Pacing

    Testing Burst Pacing Figure 11: Burst pacing pop-up window Figure 12: Burst pacing screen Burst pacing can be used to terminate certain types of arrhythmias. During burst pacing, the currently selected channel is stimulated with a fixed pulse amplitude (7.5 V), fixed pulse width (1.0 ms), and an adjustable pacing rate.

  • Page 37: Maximum Pacing

    The burst is delivered as long as the button is pressed. Maximum burst duration is 30 seconds. If the burst deliver button is held longer than 30 seconds, Reliaty will stop delivering burst pacing. While burst pacing in the atrium, the device will provide ventricular backup pacing if the pacing mode is a ventricular pacing mode when starting the burst.

  • Page 38: Safe Program

    Safe Program Safe Program The Safe program function sets critical pacing parameters to preset, safe values. The Safe program, when initiated, immediately interrupts all other Reliaty functions. The Safe program settings (non-programmable) are listed below: Mode: VVI RV Rate: 60 bpm Output: 7.5 V at 1.0 ms...

  • Page 39: Print And Export

    Figure 13: Report screen To print or export a report, navigate to the Report screen by selecting the Report button along the bottom of the Reliaty screen, as shown in Figure 13. To view a detailed report with both measured values and 5 second snapshots of the IEGM window, press the Details button.

  • Page 40: Report List

    Create a report : Press the New Report button to add a new report. All following measurements will be saved to this report until a new report is created or Reliaty is turned off.
  • Page 41 This is useful for documenting different configurations during implant or to store more than one Freeze screen per implantation. Reliaty allows the user to store one Freeze screen per report to document timing. A new Freeze screen recorded overwrites the previously saved Freeze screen.

  • Page 42: Device Settings

    Figure 15. Reliaty begins with the preferred parameters when it is initially turned on. To adjust these parameters, select the parameter and use the parameter wheel to change the value or select the new setting from a list.

  • Page 43: System Settings

    All changes to system settings are saved permanently in Reliaty, even after it is turned off. To change a system setting, select the Pref. set. button to move to the Preferred Settings page.
  • Page 44 Device Settings Maintenance code : The Maintenance code is used for service purposes only. Export system logfile : This option is used during unexpected device behavior. A logfile is exported via a USB stick, and the exported information is then used for analysis.

  • Page 45: Visual And Audio Signals

    Visual and Audio Signals Visual and Audio Signals Reliaty includes audio and visual signals to alert the user. These signals include a tone for confirmation of user input, a beep to warn for low battery, and LEDs to indicate pacing and sensing.

  • Page 46: Patient Cables

    PA-1-B; IS-1 0.8 m (S) 121°C adapters connector with PA-2 (31.5 in) adapter PK-67-L PK-155 is disposable PK-67-S Alligator clips (78.7 in) and cannot be with (PK-155) re-sterilized PK-155 Table 1: Cables compatible with Reliaty...

  • Page 47: Power Supply

    12 hours when the batteries are new. Also, the batteries should be removed if Reliaty will not be used for a prolonged period of time to avoid draining battery life. Rechargeable batteries are contraindicated for Reliaty because they do not allow for a precise calculation of the remaining operation time.

  • Page 48: Battery Exchange

    Battery replacement while the device is in use will not interrupt Reliaty operation when a second battery cartridge or external power source is also used. The battery compartments are located on the right and left side of the device.

  • Page 49: Power Supply Management

    Power Supply To ensure operation of Reliaty during battery replacement, replace the batteries in the depleted cartridge first. Reliaty comes with a third battery cartridge for quick battery exchange. Power Supply Management Replace left Replace right cartridge cartridge Immediately connect the external power supply! Do not replace any battery cartridge.
  • Page 50 Using battery only, remaining operation time is longer than 4 hours Using battery only, remaining operation time is between 2 and 4 hours Using battery only, operation time is below 30 minutes Table 2: Reliaty power supply indicators...

  • Page 51: Technical Specifications

    30% water. Disinfect by exposing to water with a 2% concentration of Lysoformin for 15 minutes. • Sterilization: Reliaty cannot be sterilized. The PK-155 cable is for single use only and cannot be sterilized. Other approved cables can be re-sterilized and re-used.
  • Page 52 Technical Specifications Input/Output Parameter Specification USB port USB 2.0 standard (12 MBit/S) Support external HP PCL5 Bluetooth interface ® compatible printer DE-15 DDC2 only for VGA interface medical monitor Socket for barrel connector External power supply 5.5 mm / 2.5 mm (0.19 in / 0.098 in) Patient connectors 2 Redel connectors PKN06 Environmental conditions...
  • Page 53 Technical Specifications Parameters Factory Parameter Specification Settings DDD, DDI, VDD, VDI, Mode VVI, VOO, AAI, AOO, OAO, OVO, ODO A: ON, OFF; RV: ON, A: ON, RV: ON, Active channels OFF; LV: ON, OFF LV: ON A: ON, OFF; RV: ON, A: OFF, RV: OFF, Pace OFF;...
  • Page 54 Technical Specifications Factory Parameter Specification Settings Burst time maximum 30 s High rate protection 200 bpm Blanking after 25 ms pace-cross-chamber Blanking after 125 ms pace-same chamber Autoshort after pace 15 ms (A, RV, LV) Measurement time 60 ms sense (A, RV, LV) Noise interval 70 ms Atrial Refractory...

  • Page 55: Specifications/System Messages/Symbols

    System Messages/Symbols Specifications / System Messages / Symbols Scope of Delivery and Accessories Name Quantity Order no. Reliaty 365 530 370 109 External power supply 367 905 Power cord 380 080 Battery cartridge 3 (2 inside device) 365 382 Batteries...
  • Page 56 System Messages/Symbols System Messages System Messages: Meaning and Measures Message text Meaning Measures Error while creating PDF file is corrupt. the *.pdf - file! • D elete unused data on Insufficient Storage medium storage device. remaining memory out of space! • U se storage device with on storage device.
  • Page 57 BIOTRONIK representative. Country-Related Information UL certification Reliaty has been certified by Underwriters Laboratories Inc. with respect to electrical shock, fire and mechanical hazards only in accordance with: • UL 60601-1 • CAN/CSAC22.2 No. 601.1 • IEC 60601-1: 1988 + A1 + A2...
  • Page 58 System Messages/Symbols Legend for the Label The label icons symbolize the following: Pacing system analyzer BIOTRONIK order number Serial number of device Date of manufacture Storage and transport temperature limitation Storage and transport atmospheric pressure limitation Storage and transport humidity limitation CE conformity marking Caution: Federal (U.S.A.) law restricts this...
  • Page 59 European Directive 2002/96/EC regarding waste electrical and electronic equipment (WEEE) applies. Return devices that are no longer used to BIOTRONIK. Battery magazine External power supply (power supply brick plus power cord) Patient with implanted lead...
  • Page 60 BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) (800) 291-0470 (fax) www.biotronik.com M4144-A 06/12 © 2012 BIOTRONIK, Inc. All rights reserved. MN015r1 10/15/12...

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