Ilivia 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 1 Friday, November 6, 2015 7:49 PM 1 en • English Product Description Intended Medical Use Intended use Ilivia 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.
17633--B_GA_IIlivia-ProMRI_mul-en.fm Page 2 Friday, November 6, 2015 7:49 PM Indications Ilivia 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 3 Friday, November 6, 2015 7:49 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 4 Friday, November 6, 2015 7:49 PM DF4/IS-1 The labeling on each device provides information pertaining to the connector port assignment in the header.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 5 Friday, November 6, 2015 7:49 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 6 Friday, November 6, 2015 7:49 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 7 Friday, November 6, 2015 7:49 PM • Depending on the device type, the device program contains not only the ICD functions but also all pacemaker functions for 1, 2 or 3 chambers. The heart rhythm is continuously monitored; each arrhythmia is classified according to the heart rate and the adjustable detection criteria. Depending on the preset values, antibradycardia as well as antitachycardia therapy is inhibited or delivered.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 8 Friday, November 6, 2015 7:49 PM 2 General Safety Instructions 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 9 Friday, November 6, 2015 7:49 PM Possible Risks Possible technical failures Technical failure of a device system cannot be entirely ruled out.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 10 Friday, November 6, 2015 7:49 PM 3 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 11 Friday, November 6, 2015 7:49 PM Unpacking the device Preventing unintentional shock delivery W WARNING W WARNING Inadequate therapy due to defective device If an unpacked device is dropped on a hard surface during handling, electronic parts could be damaged. • Use a replacement device. • Return the damaged device to BIOTRONIK. Shock delivery with activated ICD There is a risk of unintended shock delivery when handling an activated ICD.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 12 Friday, November 6, 2015 7:49 PM Overview: Implanting 1 2 Prepare the vein. Implant the leads, perform the measurements, and fixate the leads. 3 4 5 6 Form the device pocket. Connect the lead connector to the device. Insert the device. Guide the fixation suture through the opening in the header and fixate the device in the prepared device pocket. Close the device pocket. Check the device with standard tests.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 13 Friday, November 6, 2015 7:49 PM 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 14 Friday, November 6, 2015 7:49 PM Monitoring the patient when setting asynchronous modes The asynchronous modes V00 and D00 can only be set if tachyarrhythmia sensing is deactivated. This would leave the patient without sensing and therefore without ICD therapy. • Continually monitor the patient. • Keep an external defibrillator ready.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 15 Friday, November 6, 2015 7:49 PM Note the reduced pulse amplitude due to a battery voltage drop If the rate and amplitude are set very high and the pulse width is set too long at the same time, the battery voltage may temporarily drop so low that the actual pulse amplitude drops well below the selected level. • Continuously check the pacing efficiency using ECG monitoring.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 16 Friday, November 6, 2015 7:49 PM Follow-up 6 7 8 9 10 Follow-up intervals Follow-ups must be performed at regular, agreed intervals. • The first follow-up should be carried out by the physician using the programmer (in-office follow-up) approximately 3 months after implantation following the lead ingrowth phase. • 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 17 Friday, November 6, 2015 7:49 PM Replacement Indications • 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.
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417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 19 Friday, November 6, 2015 7:49 PM Timing: Post-shock pacing Parameter Post-shock duration Post-shock basic rate AV delay post shock Ventricular post-shock pacing Timing: Ventricular pacing suppression Range of values Standard VR DX DR HF OFF; 10 s; 30 s; 1 min; 2 min; 5 min; 10 min 30 ... (5) ... 100 ... (10) ... 160 bpm 50 ... (10) ...
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 20 Friday, November 6, 2015 7:49 PM Timing: Ventricular multi pole pacing Parameter Pacing polarity 2nd LV Range of values OFF; LV1 tip -> LV2 ring LV1 tip -> LV4 ring LV1 tip -> RV coil LV1 tip -> housing LV2 ring -> LV1 tip LV2 ring -> LV4 ring LV2 ring -> RV coil LV3 ring -> LV2 ring LV3 ring -> LV4 ring LV3 ring -> RV coil LV4 ring -> LV2 ring LV4 ring -> RV coil LV-LV delay 0 ... (5) ... 50 ms Pulse amplitude LV 2nd LV 0.5 ... (0.25) ... 4.0 ... (0.5) ... 6.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 21 Friday, November 6, 2015 7:49 PM Pacing: Pulse amplitude and pulse width Parameter Pulse amplitude A Pulse amplitude V/RV Pulse amplitude LV Pulse width A Pulse width V/RV Pulse width LV Range of values 0.5 ... (0.25) ... 4.0 ... (0.5) ... 6.0; 7.5 V 0.4; 0.5 ... (0.25) ... 1.5 ms Lead configuration LV on IS-1 connection Standard VR DX DR HF AUTO x x x x x x x 0.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 22 Friday, November 6, 2015 7:49 PM MRI program Tachycardia MRI program Parameter MRI program Expiration date Mode Basic rate Pulse amplitude LV Pulse width LV Pacing polarity LV Detection Range of values OFF; AUTO; ON Today ... (1) ... Today + 14 days VOO; OFF VOO; DOO; OFF V00; V00-BiV; D00; D00-BiV; OFF 70 ... (5) ... 100 ... (10) ... 160 bpm 0.5 ... (0.25) ... 4.0 ... (0.5) ... 6.0; 7.5 V 0.4; 0.5 ... (0.25) ... 1.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 23 Friday, November 6, 2015 7:49 PM Therapy: Atrial therapy 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) ... 40 ms 10 ms x Backup stimulation OFF; 70; 90; OFF x Atrial therapy in the presence of unstable atrial fibrillation: Therapy OFF; HF (high frequency) OFF x burst Rate 10 ... (5) .
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417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 25 Friday, November 6, 2015 7:49 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 26 Friday, November 6, 2015 7:49 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.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 27 Friday, November 6, 2015 7:49 PM Battery Data Battery characteristics The following data is provided by the manufacturers: Manufacturer GREATBATCH, INC. Clarence, NY 14031 GB 2992 Li/SVO/CFx 3 Calculation of service times • The services times have been calculated as follows – in all chambers depending on the device type: — Pulse amplitude: 2.5 V — Pulse width: 0.
417633--B_GA_IIlivia-ProMRI_mul-en.fm Page 28 Friday, November 6, 2015 7:49 PM Ilivia 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 Ilivia 7 HF-T (QP) Service times with battery GB 2992 without multipolar pacing: Service time [in years] at number of shocks per year Pacing 4 8 12 16 20 0% 10.1 8.4 7.2 6.3 5.5 15% 9.4 7.9 6.
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