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© BIOTRONIK SE & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. ® BIOTRONIK Home Monitoring, IEGM-Online HD and SMART Detecton are registered trademarks of BIOTRONIK SE & Co. KG 0123 0681 2012 12-D-xx Revision: B (2012-xx-xx) 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 393468--B_GA_Ilesto-II_mul-01xx_Cover.indd 2 27.09.
1 Ilesto 5/7 VR-T, VR-T DX, DR-T, HF-T ICD Family Tachyarrhythmia Therapy Cardiac Resynchronization Therapy Technical Manual for the Device Doc. Id.
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3 Table of Contents Table of Contents Table of Contents Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Therapeutic and Diagnostic Functions. . . . . . . . . . . . . . . . . 11 General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 Table of Contents
5 1 Product Description Product Description Product Description1GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto 5/7 VR-T, VR-T DX, DR-T, HF-T Intended Medical Use Intended use Ilesto 5/7 is part of a familiy of implantable cardioverter-defibrillators (ICDs). 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.
6 Indications Product Description Ilesto 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 guidelines of cardiology associations for guidance.
7 Product Description System Overview Device family The complete Ilesto 5/7 device familyconsists of several device types with a DF-1/ IS-1 or DF4/IS-1 connection. Single-chamber: VR-T and VR-T DX (only devices with a DF-1/IS-1 connection); dual-chamber: DR-T; triple-chamber: HF-T. Not all device types are available in every country. Device DF-1/IS-1 or DF4/IS-1 The device's housing is made of biocompatible titanium, welded from outside and thus hermetically sealed.
8 DF4/IS-1 lead connection Product Description The device labeling provides information pertaining to possible lead connections depending on the device type and pertaining to connection assignment: VR DR HF IS-1 RA IS-1 RA DF4 RV DF4 RV DF4 RV Connector port Lead connector Configuration Implantation site Device type RA IS-1 Bipolar Atrium DR, HF LV IS-1 Unipolar, Bipolar Left ventricle HF RV, SVC DF4 Bipolar and shock Right ventricle VR, DR, HF IS-1 LV Note: The device's DF4
9 NBD and NBG codes Product Description VVE is the NBD code for the antitachycardia mode of the single-chamber, dualchamber, and triple-chamber devices: V Shock in the ventricle V Antitachycardia pacing (ATP) in the ventricle E Detection via IEGM analysis 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 DDDRV is the NBG code for th
10 BIOTRONIK Home Monitoring® Technical manuals Order numbers for Ilesto with DF-1/IS-1 or DF4/IS-1 connection Scope of delivery Product Description 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.
11 Product Description Therapeutic and Diagnostic Functions Diagnostic functions Antitachycardia pacing Cardioversion, defibrillation Antibradycardia pacing and CRT • Data from implantation and the most recent interrogations and follow-ups are recorded as well as arrhythmia episodes; they are stored together with other data to assess patients and the state of the device at any time.
12 Storing programs Home Monitoring functions Product Description The parameter settings can be saved in 3 individual therapy programs. • The device automatically sends information to the transmitter once a day. It also sends messages related to events, which are immediately forwarded to the Service Center. In addition to this, test messages can be initiated using the programmer. • Appointments for Home Monitoring-supported follow-ups can be scheduled via the HMSC. This applies to Ilesto 5/7.
13 2 General Safety Instructions General Safety Instructions General Safety Instructions2GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto 5/7 VR-T, VR-T DX, DR-T, HF-T Operating Conditions Care during shipping and storage Delivery in shipment mode • Devices are not to be stored or transported close to magnets or sources of electromagnetic interference. • Note the effects of the storage duration; see Battery Data.
14 General Safety Instructions Possible Complications General information on medical complications Skeletal myopotentials 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.
15 General Safety Instructions Possible Risks Contraindicated procedures Risky therapeutic and diagnostic procedures The following procedures are contraindicated as they may cause harm to the patient or damage the device and, as a result, put the system functionality at risk: • Therapeutic ultrasound: Harm to the patient via excess warming of body tissue near the device system • Transcutaneous electrical nerve stimulation • Hyperbaric oxygen therapy • Applied pressures higher than normal pressure
16 Magnetic resonance imaging General Safety Instructions Magnetic resonance imaging (MRI) is contraindicated due to the high frequency fields and the associated 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. • Under certain conditions one can perform special measures with magnetic resonance imaging to protect the patient and device.
17 3 Implantation Implantation Implantation3GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto 5/7 VR-T, VR-T DX, DR-T, HF-T Implantation Procedure Having parts ready The following parts that correspond to the requirements of the EC Directive 90/ 385/EEC are required: • BIOTRONIK device with blind plug and screwdriver • BIOTRONIK leads and lead introducer set — Single-chamber device: One bipolar ICD lead with 1 or 2 shock coils for the ventricle — Dual-chamber device: One bipo
18 Checking parts Implantation site Preventing leakage currents Implantation Damage to any of the parts can result in complications or technical failures. • Check for damage before and after unpacking all parts. • Replace damaged parts. • The ICD is shipped with tachyarrhythmia therapy deactivated and is only to be connected and implanted in this state. • Leads may not be shortened.
19 Implantation Connecting the lead connector to the device 1 Disconnect stylets and stylet guides. 2 DF-1/IS-1 connection: • Connect the DF-1 connector for the right-ventricular shock coil to RV. • Connect the DF-1 connector for the supraventricular shock coil to SVC. Or connect a subcutaneous array to SVC. DF4/IS-1 connection: • 3 Connect the DF4 connector to RV DF-1/IS-1 connection: • Connect the bipolar IS-1 lead connector for the atrium to RA.
20 Implantation Implanting Applying the programming head Prepare the vein. 2 Implant the leads, perform the measurements, and fixate the leads. 3 Form the device pocket. 4 Connect the lead connector to the device. 5 Insert the device. 6 Guide the fixation suture through the opening in the header and fixate the device in the prepared device pocket. 7 Close the device pocket. 8 Check the device with standard tests. The programming head (PGH) features a diagram of the device.
21 Implantation Precautionary Measures while Programming Performing standard tests and monitoring the patient Cancelling telemetry Avoiding critical parameter settings Check for leads suitable for shock path Critical conditions can occur for the patient even during standard tests due to inadequate parameter settings or interrupted telemetry. • Ensure sufficient patient care even during tests.
22 Preventing conduction of atrial tachycardia Observing the shock impedance limit Preventing recurrence after therapy shock Implantation BIOTRONIK devices feature several functions to prevent conduction of atrial tachycardia to the ventricle(s): • Set mode switching for indicated patients. • Set the upper rate and the refractory periods to prevent abrupt ventricular rate switching. • Give preference to Wenckebach response and avoid 2:1 behavior.
23 Considering power consumption and service time Implantation RF telemetry requires somewhat more power: Consumption during implantation corresponds to approximately 10 days of service time and consumption during a 20-minute follow-up corresponds to approximately 3 days. • Do not establish unnecessary RF telemetry. • After 5 minutes without input, SafeSync switches to the economy mode. • Check the battery capacity of the device at regular intervals.
24 Implantation Magnet Response Application of the programming head when ICD therapy is set If a connected programming head is applied and is communicating with the programmer and ICD therapy is permanently set, detection and therapy remain intact except during the diagnostic tests. If ICD therapy is not set as permanent, no therapy is delivered when the programming head is applied.
25 Implantation Follow-up Follow-up intervals Follow-up with BIOTRONIK Home Monitoring® 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.
26 Implantation Patient Information Patient ID card A patient ID card is included in delivery. • Provide the patient with the patient ID. • Request that patients contact the physician in case of uncertainties. Prohibitory signs Places with prohibitory signs must be avoided. • Draw the patient's attention to prohibitory signs. Possible sources of interference Electromagnetic interference should be avoided in daily activities.
27 Implantation Replacement Indications Possible battery levels Elective Replacement Indication (ERI) ! • BOS: Beginning of Service: > 70% charge • MOS 1: Middle of Service: 70% to 40% residual charge • MOS 2: Middle of Service: < 40% residual charge • ERI: Elective Replacement Indication, (i.e. RRT: Recommended Replacement Time) • EOS: End of Service Elective Replacement Indication can be detected by Home Monitoring.
28 Implantation Explantation and Device Replacement Explantation • Interrogate the device status. • Deactivate VT and VF therapies prior to explantation. • Remove the leads from the header. Do not simply cut them loose. • Use state-of-the-art techniques to remove the device and, if necessary, the leads. Note: Normal oxidation processes may cause ICD housing discolorations. This is neither a device defect nor does it influence device functionality.
29 4 Parameters Parameters Parameters4GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto 5/7 VR-T, VR-T DX, DR-T, HF-T Bradycardia / CRT Parameter Range of values Standard VR DX DR HF ICD therapy OFF; ON ON x x x x Programs Display standard program; Display safe program; Display first interrogated program; Individual 1,2,3 – x x x x Parameter Range of values Standard VR DX General ICD therapy Basic rate 30 ... (5) ... 100 ... (10) ...
30 Parameters Range of values Standard DX DR HF AV dynamics Low; Medium; High; Fixed; (Individual) Low x x x – Pacing 15; 40 ... (5) ... 350 ms – x x x – Sensing Either automatic: AV delay after pacing + sense compensation Or: 40 ... (5) ... 350 ms – – At rate 1 50 ... (10) ... 130 bpm 60 bpm – At rate 2 60 ... (10) ... 140 bpm 130 bpm Sense compensation OFF -5 ... (-5) ...
31 Parameters Range of values Standard DX DR HF Intervention rate OFF; 120 ... (10) ... 200 bpm 160 bpm x x x Onset criterion 3 ... (1) ... 8 (out of 8) 5 x x x Modification of basic rate OFF; 5 ... (5) ... 30 bpm 10 bpm x x x Mode VDI(R); VDD(R) VDI x x x DDI(R); DDD(R) DDI x x – Rate OFF; 5 ... (5) ... 50 bpm 10 bpm x x x – Duration 1 ... (1) ...
32 Parameters Parameter Range of values Standard VR DX DR HF Maximum sensor rate 80 ... (10) ... 160 bpm 160 bpm x x x x Sensor gain AUTO Very low; Low; Medium; High; Very high Medium x x x x Sensor threshold Very low; Low; Medium; High; Very high Medium x x x x Rate increase 1; 2; 4; 8 bpm/cycle 2 bpm x x x x Rate decrease 0.1; 0.2; 0.5; 1.0 bpm/cycle 0.
33 Parameters Tachycardia Interval AT/AF 240 ... 600 ms 300 ms Interval VT1 OFF; 270 ... (10) ... 600 ms OFF Interval VT2 OFF; 270 ... (10) ... 500 ms Interval VF OFF; 240 ... (10) ... 400 ms 300 ms Detection counter VT1 10 ... (2) ... 60 26 Detection counter VT2 10 ... (2) ...
34 Parameters Parameter Range of values Standard VR DX DR HF Therapy: Shock Number of shocks VT1/VT2 0; 1; 2; 6; 8 8 x x x x Number of shocks VF 6; 8 8 x x x x 1. Shock for VT1/VT2 OFF 2 ... (2) ... 20 ... (5) ... 40 J 40 J x x x x 2. Shock for VT1/VT2 OFF 4 ... (2) ... 20 ... (5) ... 40 J 40 J x x x x 3rd - nth shock for VT1/VT2 4*40 J; 6*40 J 6*40 J x x x x 1. Shock for VF OFF 2 ... (2) ... 20 ... (5) ... 40 J 40 J x x x x 2. Shock for VF OFF 4 ...
35 Parameters Sensing Sensing A STD; OFF; IND STD Sensing RV STD; TWS; VFS; IND STD Sensing LV STD; OFF; IND STD Upper threshold RV 50; 75 % 50% Upper threshold LV 50; 75 % 50% Upper threshold duration after detection 110; 150 ... (50) ...
36 Parameters Diagnostics Range of values DR HF Standard For AT/AF OFF; ON For Ilesto 7: Extended ON x x x ON For SVT OFF; ON x x x ON Periodic recording When Home Monitoring OFF: OFF; 30 ... (30) ... 180 days x x x 90 days IEGM configuration RA, RV, LV RA, RV, FF FF; RV; LV x RA, RV, LV VR Parameter DX The following can be set: x Parameter Range of values VR DX DR HF The following can additionally be set for Ilesto 7: Standard Start resting period 0:00 ... (1:00) .
37 Parameters Parameter Range of values Standard VR DX DR HF Home Monitoring Home Monitoring OFF; ON OFF x x x x Time of transmission STD; 00:00 ... (01:00) ...
38 Parameters
39 5 Technical Data Technical Data Technical Data5GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto 5/7 VR-T, VR-T DX, DR-T, HF-T Mechanical Characteristics Housing Devices with a DF-1/IS-1 header: Type Connection W x H x D in mm Volume in ccm Mass in g VR, DX, DR DF-1 65 x 55 x 11 31 80 HF DF-1 65 x 58.
40 Technical Data Electrical Characteristics Standards Measuring conditions Factory settings Telemetry data International radio certification The specifications are made according to EN 45502-2-2:2008. If not indicated otherwise, all specifications refer to the following conditions: • Ambient temperature: 37 ºC ± 2 °C • Pacing/sensing: 500 Ω ± 1% • Shock: 50 Ω ±1% • Arrhythmia zones VT1, VT2, VF: OFF • Antibradycardia pacing: OFF • Home Monitoring: OFF • Nominal carrier frequency: 403.
41 Resistance to interference Technical Data • Note on device type DX (only devices with a DF-1/IS-1 connection): The EMC requirements are met as long as atrial sensitivity is set to 1.0 mV (factory settings) or values ≥ 1.0 mV. Measures must be taken to assure interference-free therapy if more sensitive values are set. • Note on device type HF: In the case of unipolar sensing, the requirement for interference voltages of ≤ 0.3 mV (tip to tip) is met.
42 Technical Data Battery Data Battery characteristics Storage period Calculation of service times The following data is provided by the manufacturers: Manufacturer GREATBATCH, INC. Clarence, NY 14031 LITRONIK GmbH & Co 01796 Pirna, Germany Battery type GB 2992 LiS 3410 RA Battery ID number shown on the programmer 3 4 Device type VR, (DX), DR, HF Battery voltage at ERI 2.5 V 2.
43 Ilesto 5 VR-T DX Technical Data Service times with GB 2992 or LiS 3410 RA battery: Longevity [in years] at number of shocks per year Stimulation Ilesto 5 DR-T 4 8 12 16 20 0% 9.48 7.76 6.57 5.70 5.03 15% 9.24 7.61 6.46 5.61 4.96 50% 8.75 7.26 6.21 5.42 4.81 100% 8.12 6.83 5.89 5.17 4.62 Service times with GB 2992 or LiS 3410 RA battery: Longevity [in years] at number of shocks per year Stimulation Ilesto 5 HF-T 4 8 12 16 20 0% 9.48 7.76 6.57 5.70 5.
44 Ilesto 7 DR-T Technical Data Service times with GB 2992 battery: Longevity [in years] at number of shocks per year Stimulation Ilesto 7 HF-T 4 8 12 16 20 0% 10.73 8.82 7.48 6.50 5.74 15% 10.22 8.47 7.23 6.31 5.59 50% 9.20 7.76 6.70 5.90 5.27 100% 8.05 6.92 6.07 5.40 4.87 Service times with GB 2992 battery: Longevity [in years] at number of shocks per year Stimulation 4 8 12 16 20 0% 9.96 8.29 7.10 6.20 5.51 15% 9.33 7.85 6.77 5.95 5.31 50% 8.12 6.
45 Technical Data Legend for the Label Label on the package The label icons symbolize the following: Manufacturing date Use by Temperature limit Order number Serial number Product identification number Dangerous voltages! CE mark Contents Follow the instructions for use Sterilized with ethylene oxide 2 Do not resterilize Do not reuse STERILIZE Do not use if packaging is damaged Non-sterile NON STERILE Transmitter with non-ionizing radiation at designated frequency Device: NBG code and c
46 Technical Data Bipolar IS-1 connector Unipolar IS-1 connector Unipolar DF-1 connector DF4 connector
