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Enitra 6/8
Pacemaker | Bradyarrhythmia Therapy |
Cardiac Resynchronization Therapy
Technical Manual
417801
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.
0123 2016
Index 417801Technical ManualEnitra 6/8
®
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.com
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Summary of Contents for BIOTRONIK Enitra 6 Series
- Page 1 Cardiac Resynchronization Therapy Technical Manual 417801 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.
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Page 2: Table Of Contents
Table of Contents Table of Contents Table of Contents Product Description ..........3 Intended Medical Use. -
Page 3: Product Description
Diagnosis and therapy forms The cardiac rhythm is automatically monitored and bradycardia arrhythmias are treated. All major therapeutic approaches from the field of cardiology and electrophysiology are unified in this pacemaker family. BIOTRONIK ® Home Monitoring enables physicians to perform therapy management at any time. -
Page 4: Indications
Guidelines of cardiological Generally approved differential diagnostic methods, indications, and societies 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). -
Page 5: Contraindications
Product Description Contraindications Contraindications Guidelines No contraindications are known for the implantation of multifunctional single- chamber, 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. Pacing modes and parameters The compatibility and effectiveness of parameter combinations must be checked and, as the case may be, adapted after programming. -
Page 6: System Overview
• Only quadripolar leads must be connected to the IS4 connector on device type HF QP with IS4. 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. - Page 7 Left ventricle HF QP Leads BIOTRONIK leads are sheathed in biocompatible silicone. They can be flexibly maneuvered, are stable long-term, and are equipped for active or passive fixation. They are implanted using a lead introducer set. Some leads are coated with polyurethane which is known to increase the gliding properties for the lead.
- Page 8 Multisite pacing in both ventricles ® BIOTRONIK Home Monitoring In addition to effective pacing therapy, BIOTRONIK provides a complete therapy 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.
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Page 9: Diagnostic And Therapy Functions
Product Description Diagnostic and Therapy Functions 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 10 Product Description Diagnostic and Therapy Functions Resynchronisation therapy 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.
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Page 11: 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. • Keep technical manuals for later use. -
Page 12: Possible Complications
Any device can be sensitive to interference, for example, when external signals are (EMI) sensed as intrinsic rhythm. • 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 13: Possible Risks
• Adhere to instructions for potentially risky therapeutic and diagnostic procedures. • Shield device against radiation. • After applying radiation, double-check the device system to make sure it is functioning properly. Note: Please contact BIOTRONIK with questions on the risk/benefit analysis. - Page 14 Under certain conditions and when maintaining mandatory measures to protect the patient and the device system, magnetic resonance imaging can be performed. BIOTRONIK devices with the "MR conditional" function bear the identification ProMRI. • The ProMRI manual – MR conditional device systems – contains detailed information on safely conducting an MRI.
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Page 15: Implantation
— Triple-chamber device: an additional unipolar, bipolar, or quadripolar LV lead • Approved connections are IS-1 and IS4: Use only adapters approved by BIOTRONIK for leads with different connections or leads from other manufacturers. • BIOTRONIK programmer (with integrated wandless telemetry or with separate SafeSync Module) and approved cables •... - Page 16 Avoid damage to the header Set screws must be tightened or loosened with care. • Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screwdrivers with torque control! • If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.
- Page 17 Implantation Implantation Procedure Connecting the lead connector Remove stylets and stylet guides. to the device • Connect the unipolar or bipolar IS-1 lead connector for the right ventricle to RV. • Connect the unipolar or bipolar IS-1 lead connector atrium to A. •...
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Page 18: Precautionary Measures While Programming
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 • After auto-initialization, perform a follow-up to see if the device system is functioning properly. - Page 19 • Set the VA criterion: The aim is to set a VA criterion that is longer than the longest measured retrograde conduction time. Preventing conduction of BIOTRONIK devices are equipped with several functions to prevent conduction of atrial tachycardia atrial tachycardia to the ventricle(s): •...
- Page 20 Implantation Precautionary Measures while Programming Consider power consumption The pacemaker permits programming of high pulse amplitudes with long pulse and service time 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.
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Page 21: Magnet Response
Applying a magnet or the programming head can result in an unphysiological 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 (where applicable ... -
Page 22: 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 23: Patient Information
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. ... -
Page 24: Replacement Indications
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 •... - Page 25 Implantation Replacement Indications Magnet response at ERI After reaching ERI, pacing is performed as follows after applying the magnet or programming head: Magnet Cycles 1 to 10 After 10th cycle response Automatic Asynchronous with 80 bpm Synchronous with basic rate reduced by 11% Asynchronous Asynchronous with 80 bpm Asynchronous with 80 bpm...
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Page 26: 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 27: Parameters
Parameters Timing Parameters Parameters4417801Technical ManualEnitra 6/8 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) 60 bpm ... - Page 28 Parameters Timing Ventricular pacing Parameter Range of values Standard SR DR HF Ventricular pacing BiV, RV; LV Triggering OFF; RVs; RVs + PVC LV T-wave protection ON; OFF Maximum trigger rate AUTO; 90 ... (10) ... 160 bpm AUTO Initially paced RV;...
- Page 29 Parameters Timing Refractory periods Parameter Range of values Standard SR DR HF RV 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);...
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Page 30: Pacing And Sensing
Parameters Pacing and Sensing Pacing and Sensing Pulse amplitude and Parameter Range of values Standard SR DR HF pulse width Pulse 0.2 ... (0.2) ... 6.0 ... (0.5) 3.0 V amplitude A/RV/LV ... 7.5 V Pulse width A/RV/LV 0.1 ...(0.1) ... 0.5 ... (0.25) 0.4 ms ... - Page 31 Parameters Pacing and Sensing Lead configuration Parameter Range of values Standard SR DR HF Sensing polarity A Unipolar; bipolar Unipolar Sensing polarity RV Unipolar; bipolar Unipolar Sensing polarity LV Unipolar; bipolar Unipolar Pacing polarity A Unipolar; bipolar Unipolar Pacing polarity RV Unipolar;...
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Page 32: Rate Adaptation
Parameters Rate Adaptation Rate Adaptation CLS modes: closed loop Parameters valid for 8 series devices: stimulation Parameter Range of values Standard SR DR HF Maximum CLS rate 80 ... (10) ... 160 bpm 120 bpm CLS response Very low; Low; Medium; Medium High;... -
Page 33: Mri Program
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 Expiration date Today's date ... (1 day) ... Today's date today's date + 14 days + 14 days MRI mode OFF;... -
Page 34: Preset Programs
Parameters Preset Programs Preset Programs Standard and safe program Mode after auto-initialization: Parameter Factory Standard Safe program SR DR HF setting Mode VVIR In the AAI mode, the safe program is also AAI. Mode DDDR Lead configuration, determined and set immediately after connection (auto lead check) Parameter Factory... - Page 35 Parameters Preset Programs Parameter Factory Standard Safe SR DR HF setting program Refractory period A AUTO AUTO — Refractory period RV 250 ms 250 ms 300 ms Refractory period LV 200 ms 200 ms 200 ms Mode switching — Onset criterion 5-out-of 8 5-out-of 8 —...
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Page 36: Tolerances Of Parameter Values
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) ±... -
Page 37: Technical Data
31.2 HF-T QP Note: D = housing without header X-ray identification All device types receive the BIOTRONIK logo for X-ray identification. It can be found centrally between the circuitry and the battery. Materials in contact with • Housing: Titanium body tissue •... -
Page 38: Electrical Characteristics
Telemetry data • MICS frequency: 402 - 405 MHz • Maximum power of transmission: < 25 µW (-16 dBm) International radio ® Devices with BIOTRONIK Home Monitoring are equipped with an antenna for certification wireless communication. • Telemetry information for Australia:... - Page 39 (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 EN 45502-2-1: 2003, § 27.5.1 at the highest sensitivity.
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Page 40: Battery Data
Technical Data Battery Data Battery Data Battery characteristics The following data is provided by the manufacturers: Manufacturer Wilson GREATBATCH, LITRONIK GmbH, INC. Clarence, NY 14031 01796 Pirna, Germany Battery type GB 3193 LiS 2650MK LiS 3150MK System LiMn0 LiMn0 Device type SR;... - Page 41 Technical Data Battery Data Mean service times HF For triple-chamber devices of the 8 series 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...
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Page 42: Legend For The Label
MR scan under precisely defined conditions. Compabiltiy with telemetry protocol version 2 of BIOTRONIK Home Monitoring Uncoated device: NBG code and compatible leads Example Screwdriver...
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