BIOTRONIK Eluna 8 Technical Manual

Pacemaker

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Technical manual (109 pages)

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Page 1 Revision: F (2014-08-04) © BIOTRONIK SE & Co. KG All rights reserved. Specification subject to modification, revision and improvement. ® Registered trademarks of BIOTRONIK SE & Co. KG: BIOTRONIK Home Monitoring, Eluna, ProMRI BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin ·...
Page 2: Table Of Contents
Table of Contents Table of Contents Table of Contents Product Description ..........3 Intended Medical Use .
Page 3: Product Description
All major therapeutic approaches from the field of cardiology and electro- ® physiology are unified in this pacemaker family. BIOTRONIK Home Monitoring enables physicians to perform therapy management at any time. Required expertise In addition to having basic medical knowledge, the user must be thoroughly familiar with the operation of a device system.
Page 4: Contraindications
Product Description Pacing modes For the following symptomatic, the following pacing modes are indicated: Symptom/expectation Pacing mode Sick sinus syndrome Dual-chamber pacing Chronic, symptomatic second and third-degree AV block Dual-chamber pacing Adams-Stokes syndrome Dual-chamber pacing Symptomatic bilateral bundle branch block when tach- Dual-chamber pacing yarrhythmia and other causes have been ruled out •...
Page 5: System Overview
Right ventricle SR, DR, HF IS-1 Unipolar, bipolar Left ventricle Note: Use only adapters approved by BIOTRONIK for leads with different connec- tions. • If you have any questions concerning the compatibility of other manufacturers' leads, please contact BIOTRONIK. Leads BIOTRONIK leads are sheathed in biocompatible silicone.
Page 6 Product Description Programmer Implantation and follow-up are performed with BIOTRONIK's portable programmer: There are programmers with integrated or external SafeSync Module for RF telemetry. The programmer is used during implantation to transfer the current device program to the device. The pacing thresholds can be determined and all tests can be performed during in-office follow-up.
Page 7 Sensing in the atrium and ventricle Pulse inhibition and pulse triggering Rate adaptation Multisite pacing in both ventricles BIOTRONIK In addition to effective pacing therapy, BIOTRONIK provides a complete therapy ® Home Monitoring management system: • With Home Monitoring, diagnostic and therapeutic information and technical data are automatically sent to a stationary or mobile transmitter via an antenna in the device header.
Page 8: Diagnostic And Therapy Functions
Product Description Diagnostic and Therapy Functions General overview 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.
Page 9 Product Description Programs There are two types of therapy programs: • Default parameters are offered for the most common indications (Program Consult function). • Individual settings can be saved in 3 individual therapy programs. Home Monitoring functions The device automatically sends information to the transmitter once a day. Addition- ally, the test messages can be initiated using the programmer.
Page 10: General Safety Instructions
— Technical manuals for cables, adapters and accessories • Technical manuals are either included in hard copy form in the storage package or in digital form on the internet: manuals.biotronik.com • Follow all relevant technical manuals. • Preserve technical manuals for later use.
Page 11: Possible Complications
(EMI) sensed as intrinsic rhythm or if measurements prevent rate adaptation. • BIOTRONIK devices have been designed so that their susceptibility to EMI is minimal. • Due to the intensity and variety of EMI, there is no guarantee for safety. It is generally assumed that EMI produces only minor symptoms in patients - if any.
Page 12: Possible Risks
• Adhere to instructions for potentially risky therapeutic and diagnostic proce- dures. • Shield device against radiation. • After applying radiation, double-check the device system to make sure it is func- tioning properly. Note: Please contact BIOTRONIK with questions on the risk/benefit analysis.
Page 13 Under certain conditions and when maintaining mandatory measures, magnetic resonance imaging can be performed to protect patient and device system. BIOTRONIK devices with the "MR conditional function bear the identification ® ProMRI ®...
Page 14: Implantation
— Triple-chamber device: an additional unipolar or bipolar LV lead • Approved connections are IS-1: Use only adapters approved by BIOTRONIK for leads with different connections or leads from other manufacturers. • BIOTRONIK programmer (with integrated SafeSync RF telemetry or with sepa- rate SafeSync Module) and approved cables •...
Page 15 Avoid damage to the header Set screws must be tightened or loosened with care. • Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screw- drivers with torque control! • If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.
Page 16 Implantation Connecting the lead Disconnect stylets and stylet guides. connector to the device • Connect the unipolar or bipolar IS-1 lead connector ventricle to RV. • Connect the unipolar or bipolar IS-1 lead connector atrium to A. • Connect the unipolar or bipolar IS-1 lead connector ventricle to LV. Push the lead connector into the header without bending the conductor until the connector tip becomes visible behind the set screw block.
Page 17: Precautionary Measures While Programming
Implantation Precautionary Measures while Programming Checking the device system • After auto-initialization, perform a follow-up to see if the device system is func- tioning properly. • Perform a pacing threshold test to determine the pacing threshold. Performing standard tests Critical conditions can occur for the patient even during standard tests due to inad- and monitoring the patient equate parameter settings or interrupted telemetry.
Page 18 • If the function is not yet automatically set: activate PMT protection. • Set the VA criterion. Preventing conduction BIOTRONIK devices are equipped with several functions to prevent conduction of of atrial tachycardia atrial tachycardia to the ventricle(s): • Set Mode Switching for indicated patients.
Page 19: Magnet Response
Applying a magnet or the programming head can result in an unphysiological standard program rhythm change and asynchronous pacing. The magnet response is set as follows in the standard program of BIOTRONIK pacemakers: • Asynchronous: For the duration of the magnet application – mode D00 (possibly V00 / A00) without rate adaptation;...
Page 20: Follow-Up
(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. Follow-up with BIOTRONIK Monitoring using the Home Monitoring function does not serve to replace regular ®...
Page 21: Replacement Indications
Implantation Replacement Indications Possible battery levels The time span from the beginning of service (BOS) to elective replacement indica- tion (ERI) is determined by, among others, the following: • Battery capacity • Lead impedance • Pacing program • Pacing to inhibition ratio •...
Page 22: Explantation And Device Replacement
BIOTRONIK takes back used products for the purpose of environmentally safe disposal. • Clean the explant with a solution of at least 1% sodium hypochlorite. • Rinse with water. • Fill out explantation form and send to BIOTRONIK together with the cleaned device.
Page 23: Parameters
Parameters Parameters Parameters4403587Technical ManualEluna SR(-T), DR(-T), HF(-T) Timing Basic rate day/night Parameter Range of values Standard SR DR HF Basic rate 30 ... (5) ... 100 ... (10) ... 200 bpm 60 bpm 50 bpm Night rate OFF; 30 ... (5) ... 100 ... (10) ...
Page 24 Parameters Ventricular pacing Parameter Range of values Standard SR DR HF Ventricular pacing Triggering OFF; RVs; RVs + PVC LV T-wave protection ON; OFF Maximum  AUTO;  AUTO trigger rate 90 ... (10) ... 160 bpm Initially paced RV; LV chamber VV delay after Vp 0 ...
Page 25: Pacing And Sensing
Parameters Refractory periods Parameter Range of values Standard SR DR HF Refractory period 200 ... (25) ... 500 ms 250 ms Atrial refractory AUTO AUTO period Atrial refractory 300 ... (25) ... 775 ms 350 ms period in the modes AAI(R);...
Page 26 Parameters Atrial capture control Parameter Range of values Standard SR DR HF Atrial capture control ATM (monitoring only); ON; OFF Minimum amplitude 0.5 ... (0.1) ... 4.8 V 1.0 V Threshold test start 2.4 ... (0.6) ... 4.8 V 3.0 V Safety margin 0.5 ...
Page 27: Rate Adaptation
Parameters IEGM recordings Parameter Range of values Standard SR DR HF IEGM recordings 8 series: — 20 (quantity); each max. 10 s 6 series: 12 (quantity); each max. 10 s Types of IEGM High atrial rate (HAR) recordings Mode switching High ventricular rate (HVR) 8 series:...
Page 28: Mri Program
Parameters MRI Program MRI modes Modes valid for devices marked ProMRI Mode Range of values Standard SR DR HF MRI Program ON; OFF MRI mode OFF; A00; V00 — OFF; D00; A00; V00 — OFF; D00; A00; V00; — D00-BiV; V00-BiV MRI parameters Preset parameters in the MRI program: Parameter...
Page 29 Parameters Parameter Factory Standard Safe SR DR HF settings program program AV hysteresis — Sense compensation -45 ms -45 ms — AV safety delay 100 ms 100 ms — VV delay LV T-wave protection Far-field protection 100 ms 100 ms —...
Page 30: Tolerances Of Parameter Values
Parameters Tolerances of Parameter Values Parameter Range of values Tolerance Basic rate 30 ... (5) ... 100 ... ± 20 ms (10) ... 200 bpm Basic interval 1000 ms ± 20 ms Magnet rate (magnet interval) 90 bpm (664 ms) ±...
Page 31: Technical Data
(Ua). With increasing pacing duration (tb), the pulse amplitude is reduced dependent on the pacing impedance. All variants of BIOTRONIK devices comply with the requirements of  Resistance to interference prEN 45502-2-1: 2006, § 27.5.1 at the highest sensitivity.
Page 32: Battery Data
Technical Data Battery Data Battery characteristics The following data is provided by the manufacturers: Manufacturer LITRONIK GmbH, 01796 Pirna, Germany Battery type LiS 3150M System LiMn0 Device type SR(-T); DR(-T); HF-T Battery voltage at BOS 3.1 V Open-circuit voltage 3.1 V Nominal capacity 1.2 Ah Remaining capacity at ERI...
Page 33 Technical Data Without using RF telemetry: Amplitude Impedance [Ω] Pacing 100% 1.5 V >15 >15 >15 1000 >15 >15 >15 2.5 V >15 >15 13.3 1000 >15 >15 >15 3.0 V >15 14.2 11.2 1000 >15 >15 14.1 3.5 V 14.9 12.9 10.1...
Page 34 Technical Data Mean service times HF-T For triple-chamber devices, the following times (in years) result: Using RF telemetry: Pulse width: Pacing Impedance: 0.4 ms atrial + biven- A+RV+LV: A+RV: A+RV+LV: Amplitude: tricular 100% 500 Ω 500 Ω 1000 Ω LV: 800 Ω A: 2.5 V RV: 2.5 V LV: 3.5 V...
Page 35: Legend For The Label
ProMRI symbol on the packaging can be examined using an MR scan under precisely defined conditions. Compatibility with telemetry protocol version 2 of BIOTRONIK Home Monitoring Uncoated device: NBG code and compatible leads Example Coated device: NBG code and compat-...

This manual is also suitable for:

Eluna 8 sr Eluna 8 dr-t Eluna 8 hf-t Eluna 8 sr-t Eluna 8 dr Promri

BIOTRONIK Eluna 8 Technical Manual

Product Description

General Safety Instructions

Implantation

Parameters

Technical Data