Intica 5/7 ICD Family • Tachyarrhythmia Therapy • Cardiac Resynchronization Therapy Technical manual • en ICD-Familie • Tachyarrhythmietherapie • Kardiale Resynchronisationstherapie Gebrauchsanweisung • de Familia de DAI • Terapia antitaquiarritmia • Terapia de resincronización cardiaca Manual técnico • es Famille des DAI • Traitement de la tachyarythmie • Traitement par resynchronisation cardiaque Manuel technique • fr
© BIOTRONIK SE & Co. KG All rights reserved. Specifications 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 0681 2016 16-D-xx Revision: B (2015-11-06) 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.
417634--B_GA_Intica-ProMRI_mul.fm Page 1 Friday, November 6, 2015 8:13 PM 1 en • English Product Description Intended Medical Use Intended use Intica belongs to a family of implantable cardioverter-defibrillators (ICD). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing.
17634--B_GA_Intica-ProMRI_mul.fm Page 2 Friday, November 6, 2015 8:13 PM Indications Intica can treat life-threatening ventricular arrhythmias with antitachycardia pacing and defibrillation. Generally approved differential diagnostics methods, indications, and recommendations for ICD therapy apply to BIOTRONIK devices. See the current guidelines of cardiology associations for guidance.
417634--B_GA_Intica-ProMRI_mul.fm Page 3 Friday, November 6, 2015 8:13 PM Lead connectors BIOTRONIK offers ICDs with headers for different standardized lead connections: • DF-1/IS-1 and DF-1/IS-1/IS4 • DF4, DF4/IS-1 and DF4/IS-1/IS4 Connector port RA RV RV SVC LV Note: Suitable leads must comply with the norms: • A device's DF-1 connector port may only be used for connecting leads with a DF-1 connector that conform to ISO 11318.
417634--B_GA_Intica-ProMRI_mul.fm Page 4 Friday, November 6, 2015 8:13 PM DF4/IS-1 The labeling on each device provides information pertaining to the connector port assignment in the header. VR DR HF IS-1 RA DF4-LLHH RV DF4-LLHH RV Connector port RA RV LV Lead connector IS-1 DF4 IS-1 Configuration IS-1 RA Leads BIOTRONIK leads are sheathed with biocompatible silicone. They can be flexibly maneuvered, are stable long-term, and are equipped for active or passive fixation.
417634--B_GA_Intica-ProMRI_mul.fm Page 5 Friday, November 6, 2015 8:13 PM DDDR is the NBG code for the antibradycardia mode of the dual-chamber devices: Modes D D D R Note: Not all functions and parameters mentioned in this technical manual are featured by each device type of each device family.
417634--B_GA_Intica-ProMRI_mul.fm Page 6 Friday, November 6, 2015 8:13 PM BIOTRONIK Home Monitoring® In addition to effective pacing therapy, BIOTRONIK provides a complete therapy management system: • With Home Monitoring, diagnostic and therapeutic information as well as technical data are automatically sent to a stationary or mobile transmitter via an antenna in the device header. The data are encrypted and sent from the transmitter to the BIOTRONIK Service Center via the cellular phone network.
417634--B_GA_Intica-ProMRI_mul.fm Page 7 Friday, November 6, 2015 8:13 PM Therapeutic and Diagnostic Functions Antibradycardia pacing and CRT • Rate hystereses, automatic sensor functions, and a night program promote the patient's intrinsic rhythm, avoid overdrive pacing, and facilitate adaptation of the device to the individual needs of the patient. • Both atrial and ventricular thresholds are determined automatically in the device.
417634--B_GA_Intica-ProMRI_mul.fm Page 8 Friday, November 6, 2015 8:13 PM 2 Storing programs There are different therapy programs: • Parameter settings effective for the most common indications in pre-configured programs (Program Consult). • For special indications, individual parameter settings can be stored in up to three therapy programs.
417634--B_GA_Intica-ProMRI_mul.fm Page 9 Friday, November 6, 2015 8:13 PM Sterile delivery The device and the screwdriver have been gas-sterilized. Sterility is guaranteed only if the blister and quality control seal have not been damaged. Sterile packaging The device and screwdriver are packaged in two separately sealed blisters. The inner blister is also sterile on the outside so that it can be transferred in a sterile state during implantation.
417634--B_GA_Intica-ProMRI_mul.fm Page 10 Friday, November 6, 2015 8:13 PM Possible Risks Radiation therapy The use of radiation therapy must be avoided due to possible damage to the device and the resulting impaired functional safety. If this type of therapy is to be used anyway, prior risk/benefit analysis is absolutely necessary.
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417634--B_GA_Intica-ProMRI_mul.fm Page 12 Friday, November 6, 2015 8:13 PM Preventing unintentional shock delivery Overview: Implanting W WARNING 1 2 3 4 5 6 Shock delivery with activated ICD There is a risk of unintended shock delivery when handling an activated ICD. • Deactivate ICD therapy before touching the device during implantation, device replacement and explantation. Avoiding damage to the header Set screws and blind plugs (if applicable) must be tightened or loosened with care.
417634--B_GA_Intica-ProMRI_mul.fm Page 13 Friday, November 6, 2015 8:13 PM 4 5 6 7 8 Establishing RF telemetry The programmer (or the SafeSync Module) can be no more than 3 m from the device; ideally there should be no hindrances between the patient and the programmer. • Switch on RF telemetry on the programmer.
417634--B_GA_Intica-ProMRI_mul.fm Page 14 Friday, November 6, 2015 8:13 PM Cancelling telemetry Programmer interference or interrupted telemetry during performance of temporary programs (follow-up tests) can result in inadequate pacing of the patient. This is the case if the programmer can no longer be operated due to a program error or a defective touch screen and therefore the temporary program cannot be terminated.
417634--B_GA_Intica-ProMRI_mul.fm Page 15 Friday, November 6, 2015 8:13 PM Avoiding AV crosstalk When pacing using atrial ATP parameters, atrial pacing pulses can either be conducted into the ventricle or be sensed such that ventricular pacing is prevented. • Check the settings for the presence of crosstalk. • If necessary, temporarily set VVI and a rate for backup stimulation so that no ventricular pulses are prevented.
417634--B_GA_Intica-ProMRI_mul.fm Page 16 Friday, November 6, 2015 8:13 PM Follow-up Considering power consumption and service time RF telemetry requires somewhat more power: Consumption during implantation corresponds to approximately 7 days of service time and consumption during a 20-minute follow-up corresponds to approximately 2 days. • Do not establish unnecessary RF telemetry. • After 5 minutes without input, SafeSync switches to the economy mode.
417634--B_GA_Intica-ProMRI_mul.fm Page 17 Friday, November 6, 2015 8:13 PM Follow-up with the programmer Use the following procedure for in-office follow-up: 1 Record and evaluate the ECG. 2 Interrogate the device. 3 Evaluate the status and automatically measured follow-up data. 4 Check the sensing and pacing functions. 5 Possibly evaluate statistics and IEGM recordings. 6 Manually perform standard tests if necessary. 7 Possibly customize program functions and parameters.
417634--B_GA_Intica-ProMRI_mul.fm Page 18 Friday, November 6, 2015 8:13 PM 4 • VT and VF detection and all therapies are deactivated! • The antibradycardia function remains active in the VVI mode: — Ventricular pacing: RV; basic rate 50 bpm; without special pacemaker functions such as hysteresis, etc. — Pulse amplitude of 6 V; pulse width of 1.
417634--B_GA_Intica-ProMRI_mul.fm Page 19 Friday, November 6, 2015 8:13 PM Timing: AV delay Parameter AV dynamics AV delay (1 or 2) after: – Pacing – Sensing – At rate 1 – At rate 2 Sense compensation AV hysteresis mode AV hysteresis (positive) 7 series, CLS modes: AV hysteresis (positive) AV hysteresis (negative) AV scan and repetitive (positive) Timing: Upper rate Range of values Standard VR DX DR HF Low; Medium; High; Fixed; Low x x x (Individual) Parameter Upper rate Atrial upper rate 40 ...
417634--B_GA_Intica-ProMRI_mul.fm Page 20 Friday, November 6, 2015 8:13 PM Timing: Ventricular pacing Parameter Permanent Triggering LV T-wave protection Maximum trigger rate: – DDD(R) and VDD(R) Timing: Refractory periods and blanking periods Range of values RV; BiV; LV OFF; RVs; RVs+PVC OFF; ON UTR + 20; 90 ... (10) ... 160 bpm – DDI(R), VDI(R) and VVI(R) 90 ... (10) ... 160 bpm Initially paced chamber RV; LV VV delay after Vp 0 ... (5) ...
417634--B_GA_Intica-ProMRI_mul.fm Page 21 Friday, November 6, 2015 8:13 PM Timing: Rate adaptation via CLS The following parameters apply to devices of series 7: Parameter Range of values Standard VR DX DR HF Maximum sensor rate CLS response 120 bpm Medium x x x x x x x x +20 bpm x x x x No Yes x x x CLS resting rate control Vp required 80 ... (10) ... 160 bpm Very low; Low; Medium; High; Very high OFF; +10 ... (+10) ...
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417634--B_GA_Intica-ProMRI_mul.fm Page 23 Friday, November 6, 2015 8:13 PM Tachycardia Therapy: Atrial therapy The following parameters apply to devices of series 7: Parameter Range of values Standard VR DX DR Atrial therapy in the presence of stable atrial flutter: ATP type OFF; Burst; Ramp OFF x Number S1 2 ... (1) ... 10 5 x P-S1 interval 70 ... (5) ... 95% 80% x S1 decrement 5 ... (5) ...
417634--B_GA_Intica-ProMRI_mul.fm Page 24 Friday, November 6, 2015 8:13 PM Parameter R-S1 interval for VT1/VT2 R-S1 interval for VF Early ATP delivery for VF Sensing Range of values Standard VR DX DR HF 70 ... (5) ...
417634--B_GA_Intica-ProMRI_mul.fm Page 25 Friday, November 6, 2015 8:13 PM Diagnostics The following can be set: Parameter Range of values For AT/AF OFF; ON 7 series: Extended ON For SVT OFF; ON For nsVT OFF; ON Periodic recording When Home Monitoring is deactivated: OFF; 30 ... (30) ... 180 days IEGM configuration RA, RV, LV RA, RV, FF FF; RV; LV Start resting period 00:00 ... (1:00 AM) ... 23:00 hh:mm Duration of resting 0.5 ... (0.5) ...
417634--B_GA_Intica-ProMRI_mul.fm Page 26 Friday, November 6, 2015 8:13 PM 5 Technical Data Factory settings • Arrhythmia zones VT1, VT2, VF: OFF • Antibradycardia pacing: OFF • Home Monitoring: OFF Mechanical Characteristics Housing Devices with header for DF-1 and DF4 connector: Type Lead connector W x H x D in mm VR VR DX DR HF HF QP DF-1 DF4 DF-1 DF-1 DF4 DF-1 DF4 DF-1 DF4 65 x 55 x 11 65 x 54 x 11 65 x 55 x 11 65 x 55 x 11 65 x 56 x 11 65 x 58.5 x 11 65 x 56 x 11 65 x 60.5 x 11 65 x 58.
417634--B_GA_Intica-ProMRI_mul.fm Page 27 Friday, November 6, 2015 8:13 PM Telemetry data for Japan: In accordance with Japanese law, this device has been assigned an identification number under the "Ordinance concerning certification of conformity with technical regulations etc. of specified radio equipment", Article 2-1-8. • R: 202-LSD078 ATP amplitude A burst was measured at 500 Ω, an amplitude of 7.5 V (tolerance ± 1.5 V), pulse width of 1.
417634--B_GA_Intica-ProMRI_mul.fm Page 28 Friday, November 6, 2015 8:13 PM Battery Data Battery characteristics The following data is provided by the manufacturers: Manufacturer GREATBATCH, INC.
417634--B_GA_Intica-ProMRI_mul.fm Page 29 Friday, November 6, 2015 8:13 PM Intica 5/7 VR-T Service times with GB 2992 or LiS 3410 RR battery: Service time [in years] at number of shocks per year Pacing 4 8 12 16 20 0% 10.3 8.3 7.0 6.0 5.3 15% 10.1 8.1 6.8 5.9 5.2 50% 9.5 7.8 6.6 5.7 5.0 100% 8.8 7.3 6.2 5.4 4.8 Intica 5 HF-T (QP) Service times with GB 2992 or LiS 3410 RR battery: Service time [in years] at number of shocks per year Pacing 4 8 12 16 20 0% 8.9 7.4 6.3 5.5 4.9 15% 8.3 7.0 6.0 5.2 4.7 50% 7.
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