Edora 8 ProMRI® Pacemaker | Bradyarrhythmia Therapy | Cardiac Resynchronization Therapy Technical Manual 417803 Revision: B (2016-03-23) © BIOTRONIK SE & Co. KG All rights reserved. Specification subject to modification, revision and improvement. ® All product names in use may be trademarks or registered trademarks held by BIOTRONIK or the respective owner. BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin · Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 sales@biotronik.com www.biotronik.
Table of Contents Table of Contents Table of Contents Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Intended Medical Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 System Overview. . . . . . . . . . . . . . . . . . . . . . .
1 Product Description Intended Medical Use Product Description Product Description1417803Technical ManualEdora 8 Intended Medical Use Intended use Diagnosis and therapy forms Required expertise Edora is a family of implantable pacemakers that can be implanted for all bradycardia arrhythmia indications. The primary objective of the therapy consists of improving patients' symptoms that can be clinically manifested.
Product Description Indications Indications Guidelines of cardiological societies Generally approved differential diagnostic methods, indications, and recommendations for pacemaker therapy apply to BIOTRONIK devices. The guidelines provided by cardiology associations offer decisive information: • We recommend observing the indications published by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC (European Society of Cardiology).
Product Description Contraindications Contraindications Guidelines Pacing modes and parameters No contraindications are known for the implantation of multifunctional singlechamber, dual-chamber, or triple-chamber pacemakers, provided differential diagnostics precedes implantation according to the appropriate guidelines and no modes or parameter combinations are configured that pose a risk to the patient.
Product Description System Overview System Overview Device family This device family consists of single-chamber, dual-chamber and triple-chamber devices with or without Home Monitoring. Not all device types are available in every country.
IS-1/IS4 Product Description System Overview The device labeling provides information pertaining to the connection assignment: HF QP Leads Connector Lead port connector Configuration Implantation site Device type RA IS-1 Unipolar, bipolar Atrium RV IS-1 Unipolar, bipolar Right ventricle HF QP LV IS4 Unipolar, bipolar Left ventricle HF QP HF QP BIOTRONIK leads are sheathed in biocompatible silicone.
NBG codes Product Description System Overview AAIR or VVIR is the NBG code for the antibradycardia mode of the single-chamber device: A/V Pacing in the atrium or ventricle A/V Sensing in the atrium or ventricle I Pulse inhibition in the atrium and ventricle R Rate adaptation DDDR is the NBG code for the antibradycardia mode of the dual-chamber device: D Pacing in the atrium and ventricle D Sensing in the atrium and ventricle D Pulse inhibition and pulse triggering R Rate adaptation DDD
Product Description Diagnostic and Therapy Functions Diagnostic and Therapy Functions General overview Diagnostics functions All the systems have extensive features that allow quick diagnosis and delivery of safe therapy for bradycardia conditions. • Automatic functions make it easy and fast to implant, configure, and check the pacemaker. • Auto-initialization after implantation: The device recognizes the implanted leads autonomously and sets the polarity.
Resynchronisation therapy Programs ProMRI devices recognize magnetic resonance imaging devices Product Description Diagnostic and Therapy Functions Triple-chamber devices have functions to configure different VV delays in order to resynchronize the ventricles. • Capture Control is also available for the left ventricle with automated tracking of the pacing threshold or automatic threshold monitoring (ATM) for trend analysis.
2 General Safety Instructions Operating Conditions General Safety Instructions General Safety Instructions2417803Technical ManualEdora 8 ! CAUTION Safety information Cardiac electrotherapy is subject to special operating conditions and possible complications and risks. • Please take all precautionary measures carefully into account.
General Safety Instructions Possible Complications Possible Complications General information on medical complications Complications for patients and device systems generally recognized among practitioners also apply to BIOTRONIK devices. • Normal complications may include fluid accumulation within the device pocket, infections, or tissue reactions. Primary sources of complication information include current scientific and technological knowledge.
General Safety Instructions Possible Risks Possible Risks Procedures to avoid Potentially risky therapeutic and diagnostic procedures The following procedures must be avoided as they may cause harm to the patient or damage the device and, as a result, put the system functionality at risk: • Therapeutic ultrasound • Transcutaneous electrical nerve stimulation • Hyperbaric oxygen therapy • Applied pressures higher than normal pressure If electrical current from an external source is conducted through
Magnetic resonance imaging General Safety Instructions Possible Risks Magnetic resonance imaging must be avoided due to the associated high frequency fields and magnetic flux density: Damage or destruction of the device system by strong magnetic interaction and damage to the patient by excessive warming of the body tissue in the area surrounding the device system.
3 Implantation Implantation Procedure Implantation Implantation3417803Technical ManualEdora 8 Implantation Procedure Having parts ready The following parts that correspond to the requirements of the EC Directive 90/385/EEC are required: • Device with screwdriver from BIOTRONIK • BIOTRONIK leads and lead introducer set — Single-chamber device: unipolar or bipolar lead for the right ventricle — Dual-chamber device: one unipolar or bipolar lead each for the atrium and for the right ventricle — Tripl
Implantation site Implantation Implantation Procedure In general, the pacemaker is implanted subcutaneously or subpectorally, depending on the lead configuration as well as the anatomy of the patient. Overview: Implanting 1 Shape the device pocket and prepare the vein. 2 Implant the leads and perform measurements. 3 Connect device and leads. 4 Insert the device. The device starts auto-initialization on its own.
Implantation Implantation Procedure Connecting the lead connector to the device 1 Remove stylets and stylet guides. 2 • • • Applying the programming head Establishing wandless telemetry 3 Push the lead connector into the header without bending the conductor until the connector tip becomes visible behind the set screw block. 4 If the lead connector cannot be inserted completely, the set screw may be protruding into the drill hole of the set screw block.
Implantation Precautionary Measures while Programming Precautionary Measures while Programming ! CAUTION Safety information The programming of device systems requires special precautions. • Please carefully take all precautionary measures into account. Checking the device system • • Performing standard tests and monitoring the patient Do not interrupt wandless telemetry during a treatment After auto-initialization, perform a follow-up to see if the device system is functioning properly.
Implantation Precautionary Measures while Programming Preventing device-induced complications BIOTRONIK devices are equipped with several functions to prevent device-induced complications to the greatest extent possible: • Measure the retrograde conduction time. • If the function is not yet automatically set: activate PMT protection. • Set the VA criterion: The aim is to set a VA criterion that is longer than the longest measured retrograde conduction time.
Consider power consumption and service time Implantation Precautionary Measures while Programming The pacemaker permits programming of high pulse amplitudes with long pulse widths at high rates to be able to adequately treat even rare diagnoses. In combination with low lead impedance, this results in a very high level of power consumption.
Implantation Magnet Response Magnet Response Programming head application When the programming head is applied, time remains for device interrogation before the device switches back to the previously set permanent therapy mode. The same applies to programming head application to establish wandless telemetry contact. Magnet response in standard program Applying a magnet or the programming head can result in an unphysiological rhythm change and asynchronous pacing.
Implantation Follow-up Follow-up Follow-up intervals Follow-up with BIOTRONIK Home Monitoring® Follow-ups must be performed at regular, agreed intervals. • Following the lead ingrowth phase, approximately 3 months after implantation, the first follow-up should be carried out by the physician using the programmer (in-office follow-up). • The next in-office follow-up should be carried out once a year and no later than 12 months after the last in-office follow-up.
Implantation Patient Information Patient Information Patient ID card A patient ID card is included in delivery. • Provide the patient with the patient ID card. • Request that patients contact the physician in case of uncertainties. Prohibitive signs Premises with prohibitive signs must be avoided. • Possible sources of interference Draw the patient's attention to prohibitory signs. Electromagnetic interference should be avoided in daily activities.
Implantation Replacement Indications Replacement Indications Possible charging status The time span from the beginning of service (BOS) to elective replacement indication (ERI) is determined by, among others, the following: • Battery capacity • Lead impedance • Pacing program • Pacing to inhibition ratio • Pacemaker circuit properties The following are the defined pacemaker operational statuses: • BOS: Beginning of Service: > 90% • ERI: Elective Replacement Indication (i.e.
Magnet response at ERI Expected service times after ERI Implantation Replacement Indications After reaching ERI, pacing is performed as follows after applying the magnet or programming head: Magnet response Cycles 1 to 10 After 10th cycle Automatic Asynchronous with 80 bpm Synchronous with basic rate reduced by 11% Asynchronous Asynchronous with 80 bpm Asynchronous with 80 bpm Synchronous Synchronous with basic rate reduced by 11% Synchronous with basic rate reduced by 11% The informatio
Implantation Explantation and Device Replacement Explantation and Device Replacement Explantation Device replacement • • • Disconnect the leads from the header. Remove the device and, if necessary, leads using state-of-the-art technology. Explants are biologically contaminated and must be disposed of safely due to risk of infection. The following applies to leads from a previous device that are intended for further use: • Check the leads prior to connecting to the new device.
4 Parameters Timing Parameters Parameters4417803Technical ManualEdora 8 Note: Unless described separately, information for device type HF also applies to device type HF QP. Timing Basic rate day/night Parameter Range of values Standard SR DR HF Basic rate 30 ... (5) ... 100 ... (10) ... 200 bpm 60 bpm x Night rate OFF; 30 ... (5) ... 100 ... (10) ... 200 bpm OFF x x x Night begins 00:00 ... (10 min) ...
Parameters Timing Ventricular pacing Parameter Range of values Standard Ventricular pacing BiV, RV; LV BiV x Triggering OFF; RVs; RVs + PVC RVs x ON x LV T-wave protection ON; OFF SR DR HF Maximum trigger rate AUTO; 90 ... (10) ... 160 bpm AUTO x Initially paced chamber RV; LV LV x VV delay after Vp 0 ... (5) ... 80 ... (10) ... 100 ms 0 ms x VV delay after Vs 0 ms x 0 ms Upper rate Parameter Range of values Standard SR DR HF Upper rate SR: in VVT mode 90 ... (10) ...
Parameters Timing Refractory periods Parameter Range of values Standard SR DR HF RV refractory period 200 ... (25) ... 500 ms 250 ms x Atrial refractory period AUTO Atrial refractory period in the modes AAI(R); AAT(R); DDT 300 ... (25) ... 775 ms x x AUTO x x 350 ms x x x x LV refractory period 200 ms 200 ms AUTO PVARP OFF; ON ON x PVARP 175 ... (25) ...
Parameters Pacing and Sensing Pacing and Sensing Pulse amplitude and pulse width Parameter Range of values Standard SR DR HF Pulse amplitude A/RV/LV 0.2 ... (0.2) ... 6.0 ... (0.5) ... 7.5 V 3.0 V x x x Pulse width A/RV/LV 0.1 ...(0.1) ... 0.5 ... (0.25) ... 1.5 ms 0.4 ms x x x Parameter Range of values Standard SR DR HF Sensitivity AUTO; 0.5 ... (0.5) ... 7.5 mV AUTO x Sensitivity A AUTO; 0.1 ... (0.1) ... 1.5 ... (0.5) ... 7.5 mV AUTO RV sensitivity AUTO; 0.5 ... (0.5) .
Parameters Pacing and Sensing Lead configuration Parameter Range of values Standard SR DR HF Sensing polarity A Unipolar; bipolar Unipolar x x x Sensing polarity RV Unipolar; bipolar Unipolar x x x Sensing polarity LV Unipolar; bipolar Unipolar Pacing polarity A Unipolar; bipolar Unipolar x x x Pacing polarity RV Unipolar; bipolar Unipolar x x x Pacing polarity LV Device type HF: LV1 tip -> LV2 ring LV1 tip -> RV ring LV2 ring -> LV1 tip LV2 ring -> RV ring LV1 tip -> h
Parameters Rate Adaptation Rate Adaptation CLS modes: closed loop stimulation R modes: Accelerometer Parameter Range of values Standard SR DR HF Maximum CLS rate 80 ... (10) ... 160 bpm 120 bpm x x x CLS response Very low; Low; Medium; High; Very high Medium x x x CLS resting rate control OFF; +10 ... (10) ...
Parameters MRI Program MRI Program MRI modes Modes valid for devices marked ProMRI: Mode Range of values Standard SR DR HF MRI program ON; OFF; AUTO OFF x x x Expiration date Today's date ... (1 day) ... today's date + 14 days Today's date x + 14 days x x MRI mode OFF; A00; V00 Dependent on permanent program x Range of values Standard SR DR HF Basic rate 70 ... (10) ...
Parameters Preset Programs Preset Programs Standard and safe program Mode after auto-initialization: Parameter Factory setting Standard Safe program SR DR HF Mode VVI VVIR VVI In the AAI mode, the safe program is also AAI.
Parameters Preset Programs Parameter Factory setting Standard Safe program Refractory period A AUTO AUTO — Refractory period RV 250 ms 250 ms 300 ms SR DR HF x x x x x Refractory period LV 200 ms 200 ms 200 ms Mode switching ON ON — x x Onset criterion 5-out-of 8 5-out-of 8 — x x Resolution criterion 5-out-of 8 5-out-of 8 — x x Intervention rate 160 bpm 160 bpm — x x Switches to DDIR DDIR — x x The basic rate with mode switching +10 bpm +10 bpm —
Parameters Tolerances of Parameter Values Tolerances of Parameter Values Parameter Range of values Tolerance Basic rate 30 ... (5) ... 100 ... (10) ± 20 ms ... 200 bpm Basic interval 1000 ms ± 20 ms Magnet rate (magnet interval) 90 bpm (664 ms) ± 20 ms Pulse amplitude 0.2 ... 7.5 V The greater value of ±50 mV or +20/-25% Pulse width 0.1 ... 1.5 ms ±10% Sensitivity A EN 45502-2-1 triangle pulse 0.1 ... 0.2 mV ±0,05 mV 0.3 ... 7.
5 Technical Data Mechanical Characteristics Technical Data Technical Data5417803Technical ManualEdora 8 Mechanical Characteristics Measurements for the housing Device W x H x D [mm] Single-chamber SR(-T) 48 x 40 x 6.5 Volume [cm3] Mass [g] 10 20.8 Dual-chamber DR(-T) 48 x 44 x 6.5 11 23.2 Triple-chamber HF-T 53 x 52 x 6.5 14 26.9 Triple-chamber HF-T QP 53 x 53 x 6.5 15 31.
Technical Data Electrical Characteristics Electrical Characteristics Components and input values Electrically conductive surface Telemetry data International radio certification Electrical characteristics determined at 37°C, 500 Ω: Circuit technology Dycostrate Input impedance > 10 kΩ Pulse form Biphasic, asymmetric Polarity Cathodic The device housing has the form of a flattened ellipsoid.
Pulse form Technical Data Electrical Characteristics The pacing pulse has the following form: The pulse amplitude reaches its maximum value at the beginning of the pulse (Ua). With increasing pacing duration (tb), the pulse amplitude is reduced dependent on the pacing impedance. Resistance to interference All variants of BIOTRONIK devices comply with the requirements of EN 45502-2-1: 2003, § 27.5.1 at the highest sensitivity.
Technical Data Battery Data Battery Data Battery characteristics The following data is provided by the manufacturers: Manufacturer Shortening of the service time after long storage period Power consumption Calculation of service times Mean service times SR Battery type GB 3193 LiS 2650MK LiS 3150MK System QMR LiMn02 LiMn02 Device type SR; DR Battery voltage at BOS 3.3 V 3.1 V 3.1 V HF; HF QP Open-circuit voltage 3.3 V 3.1 V 3.
Mean service times HF Technical Data Battery Data For triple-chamber devices the following times result when set to DDDR with a basic rate of 60 bpm, 100% biventricular pacing and a pulse width of 0.4 ms at an impedance of 500 Ω: Amplitude Pacing Average service time A: 2.5 V 10% 9 years, 8 months RV: 2.5 V LV: 2.5 V 100% A: 3.0 V 10 % RV: 3.0 V LV: 3.0 V 100% A: 5.0 V RV: 5.0 V LV: 5.
Technical Data Legend for the Label Legend for the Label The label icons symbolize the following: Manufacturing date Use by Storage temperature Order number Serial number Product identification number CE mark Contents Follow the instructions for use Sterilized with ethylene oxide Do not resterilize Single use only.
