BIOTRONIK Ilesto 5 VR-T User manual

Ilesto
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ICD Familie • Tachyarrhythmietherapie • Kardiale Resynchronisationstherapie
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Technical Manual
Technická příručka
Brugermanual
Gebrauchsanweisung
Manual técnico
Käyttöohje
Manuel technique
Manuale tecnico di istruzione
Gebruikshandleiding
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393468--B_GA_Ilesto-II_mul-01xx_Cover.indd 1 27.09.2012 15:44:48

BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel [phone]
Fax [phone]
[e-mail]
www.biotronik.com
12-D-xx
Revision: B (2012-xx-xx)
© BIOTRONIK SE & Co. KG
All rights reserved. Specications subject
to modication, revision and improvement.
® BIOTRONIK Home Monitoring, IEGM-Online HD
and SMART Detecton are registered trademarks
of BIOTRONIK SE & Co. KG
0123
0681 2012
393468--B_GA_Ilesto-II_mul-01xx_Cover.indd 2 27.09.2012 15:44:48

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.: GA-HW_en--mul_393468-B
Index GA-HW_en--mu l_393468-BTechnical[nb sp ]Manual for the[ nbsp ]DeviceIl esto 5/7 VR-T, VR-T DX, DR -T, HF-T

2

3Table of Contents
Table of Contents
Table of Con tents
Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Therapeutic and Diagnostic Functions. . . . . . . . . . . . . . . . . 11
General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Precautionary Measures while Programming . . . . . . . . . . 21
Magnet Response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Replacement Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Explantation and Device Replacement. . . . . . . . . . . . . . . . . 28
Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Bradycardia / CRT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Tachycardia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Home Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . 39
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

4Table of Contents

5Product Description
1 Product Description
Product Description1G A-HW_en--mul_393468-BTechnical[nbsp ]Manua l for the[nbsp ]DeviceI lesto 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 resynchroni-
zation therapy with multisite ventricular pacing.
The implantation of an ICD is a symptomatic therapy with the following objectives:
• Termination of spontaneous ventricular fibrillation (VF) through shock delivery
• Termination of spontaneous ventricular tachycardia (VT) through antitachy-
cardia pacing (ATP); in case of ineffective ATP or hemodynamically not toler-
ated VT, with shock delivery
• Cardiac resynchronization through multisite ventricular pacing (triple-
chamber devices)
• Compensation of bradycardia through ventricular (single-chamber devices) or
AV sequential pacing (DX, dual- and triple-chamber devices)
Diagnosis and therapy
forms
The device monitors the heart rhythm and automatically detects and terminates
cardiac arrest resulting from ventricular tachyarrhythmia. All major therapeutic
approaches from the field of cardiology and electrophysiology are included. BIO-
TRONIK 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 and the operation conditions of a device system.
• Only qualified medical specialists having this special knowledge required are
permitted to use implantable devices.
• If users do not possess this knowledge, they must be trained accordingly.

6Product Description
Indications Ilesto can treat life-threatening ventricular arrhythmias with antitachycardia
pacing and defibrillation.
Generally approved differential diagnostics methods, indications, and recommen-
dations for ICD therapy apply to BIOTRONIK devices. See the guidelines of cardi-
ology associations for guidance.
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). This also applies to the guidelines published
by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the
American Heart Association (AHA), and other national cardiology associations.
Single-chamber and dual-
chamber
Single-chamber and dual-chamber ICDs are indicated for patients with the fol-
lowing risk:
• Sudden cardiac death caused by ventricular arrhythmias
Triple-chamber Triple-chamber ICDs are indicated for patients with the following risks:
• Sudden cardiac death caused by ventricular arrhythmias
• Congestive heart failure with ventricular asynchrony
Also indicated for primary prophylaxis in congestive heart failure patients is Ilesto.
Contraindications Known contraindications:
• Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning,
electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction
• Such frequent VT or VF that the therapies would cause an unacceptably rapid
depletion of the device batteries
• VT with few or without clinically relevant symptoms
• VT or VF treatable by surgery
• Concomitant diseases that would substantially limit a positive prognosis
• Accelerated idioventricular rhythm

7Product 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 The device's housing is made of biocompatible titanium, welded from outside and
thus hermetically sealed. The ellipsoid shape facilitates implantation in the pec-
toral muscle area. The connections for bipolar pacing and sensing (and unipolar
connections for the triple-chamber device) as well as for shock delivery are found
in the device header. The housing serves as a potential antipole during shock
delivery or in the case of unipolar lead configuration.
DF-1/IS-1 or DF4/IS-1 BIOTRONIK provides ICDs with headers for different standardized lead connec-
tions: DF-1/IS-1 and DF4/IS-1.
DF-1/IS-1 lead connection The device labeling provides information pertaining to possible lead connections
depending on the device type and pertaining to connection assignment:
Note: The device type DX can only be connected using a DF-1/IS-1 connector.
VR DX DR HF
DF-1
RV
DF-1
SVC
IS-1
RV
DF-1
RV
DF-1
SVC IS-1
RA
IS-1
RV
DF-1
RV
DF-1
SVC IS-1
RA
IS-1
RV
DF-1
RV
DF-1
SVC IS-1 RA
IS-1
RV
IS-1
LV
Connector port Lead con-
nector Configuration Implantation site Device type
RV DF-1 Shock coil Right ventricle VR, DX, DR, HF
SVC DF-1 Shock coil Superior vena cava VR, DX, DR, HF
RA IS-1 Bipolar Atrium DX, DR, HF
(R)V IS-1 Bipolar (Right) ventricle VR, DX, DR, HF
LV IS-1 Unipolar, Bipolar Left ventricle HF

8Product Description
DF4/IS-1 lead connection The device labeling provides information pertaining to possible lead connections
depending on the device type and pertaining to connection assignment:
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.
They are implanted using a lead introducer set. Some leads are coated with poly-
urethane which is known to increase the sliding properties for the lead. Leads with
steroids reduce inflammatory processes. The fractal design of the electrodes pro-
vides for low pacing thresholds. BIOTRONIK provides adapters to connect already
implanted leads to new devices.
Telemetry Telemetric communication between the device and the programmer can be carried
out following initialization either by applying the programming head (PGH) to the
device or by using radio frequency (RF) telemetry in the programmer. BIOTRONIK
calls this function SafeSync®.
Programmer Implantation and follow-up are performed with BIOTRONIK's portable pro-
grammer. There is one with integrated RF telemetry and one with a separate
SafeSync Module. 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. In addition to this, the
programmer is used to set mode and parameter combinations, as well as for inter-
rogation and saving of data from the device. Leadless ECG, IEGM, markers and
functions are displayed simultaneously on the color display.
Modes The mode setting depends on the individual diagnosis:
VR DR HF
DF4
RV
DF4
RV
IS-1
RA
DF4
RV
IS-1
RA IS-1
LV
Connector
port Lead con- nector 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
Note: The device's DF4 connector port may only be used for connecting leads
with a DF4 connector that conform to ISO 27186.
Device type Modes
VR VVI; VVIR; V00; OFF
DX VDD; VDDR; VDI; VDIR; VVI; VVIR; V00; OFF
DR, HF DDD; DDDR; DDI; DDIR; VDD; VDDR; VDI; VDIR
VVI; VVIR; AAI; AAIR; V00; D00; OFF