BIOTRONIK Cardiac Airbag User manual

(Draft)
Cardiac Airbag /
Cardiac Airbag-T
Family of Implantable Cardioverter
Defibrillators and Software Cartridge for
TMS 1000PLUS and EPR 1000PLUS
Technical Manual

X-ray Identification
Cardiac Airbag/Cardiac Airbag-T
Implantable Cardioverter Defibrillator
Inside the housing, top left-hand side:
Year of manufacture
X-Ray identification
EI•
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the
order of, a physician.
2003 BIOTRONIK, Inc., all rights reserved.

Cardiac Airbag Technical Manual i
Contents
1. General...........................................................................1
1.1 System Description....................................................1
1.2 Indications and Usage ...............................................2
1.3 Contraindications .......................................................2
1.4 Warnings and Precautions.........................................3
1.4.1 Sterilization, Storage, and Handling ..................3
1.4.2 Device Implantation and Programming..............4
1.4.3 Lead Evaluation and Connection.......................6
1.4.4 Follow-up Testing...............................................7
1.4.5 Pulse Generator Explant and Disposal..............8
1.4.6 Hospital and Medical Hazards ...........................9
1.4.7 Home and Occupational Hazards......................11
1.4.8 Cellular Phones..................................................11
1.4.9 Electronic Article Surveillance (EAS).................12
1.4.10 Home Appliances...............................................12
1.5 Adverse Events..........................................................13
1.5.1 Potential Adverse Events...................................13
1.5.2 Observed Adverse Events .................................14
1.6 Clinical Studies ..........................................................17
1.6.1 Patients Studied.................................................17
1.6.2 Methods .............................................................18
1.6.3 Results ...............................................................18
1.7 Patient Selection and Treatment ...............................20
1.7.1 Individualization of Treatment............................20
1.7.2 Specific Patient Populations ..............................20
1.8 Patient Counseling Information .................................20
1.9 Evaluating Prospective ICD Patients.........................21
2. Device Features ............................................................22
2.1 Sensing ......................................................................22
2.1.1 Ventricular Sensitivity Settings ..........................22
2.1.2 Minimum Ventricular Threshold .........................25
2.2 Ventricular Tachyarrhythmia Detection ......................25
2.2.1 VF Classifications ..............................................26
2.2.2 VT Interval Counters ..........................................26
2.2.3 VT Classification ................................................26
2.2.4 Onset and Stability .............................................27

ii Cardiac Airbag Technical Manual
2.3 Tachyarrhythmia Redetection ....................................28
2.3.1 VT Redetection ..................................................28
2.3.2 VF Redetection ..................................................28
2.3.3 Tachyarrhythmia Termination ............................28
2.4 Tachyarrhythmia Therapy ..........................................28
2.4.1 Shock Therapy...................................................29
2.5 Bradycardia Therapy .................................................31
2.5.1 Bradycardia Pacing Modes................................31
2.5.2 Basic Rate..........................................................31
2.5.3 Rate Adaptation .................................................31
2.5.4 Gain and Threshold ...........................................32
2.5.5 Rate Increase / Decrease ..................................32
2.5.6 Maximum Sensor Rate ......................................32
2.5.7 Pulse Amplitude .................................................32
2.5.8 Pulse Width........................................................33
2.5.9 Noise Response.................................................33
2.5.10 Post Shock Pacing.............................................33
2.6 Special Features ........................................................33
2.6.1 Home Monitoring (Cardiac Airbag-T Only) ........33
2.6.2 Real-time IEGM Transmission...........................37
2.6.3 Capacitor Reformation .......................................37
2.6.4 Patient and Implant Data ...................................38
2.6.5 System Status....................................................39
2.6.6 Holter Memory ...................................................40
2.6.7 Arrhythmia Induction Features...........................42
2.6.8 Manual Shock ....................................................43
2.6.9 Test Shock .........................................................43
3. Software Features.........................................................44
3.1 Follow-Up Assistant (FAST) Window.........................44
3.1.1 Interrogate ICD without Follow-up .....................45
3.2 Main Function Keys ...................................................45
3.3 Parameter Window ....................................................47
4. Sterilization and Storage..............................................50
5. Implant Procedure ........................................................52
5.1 Implant Preparation ...................................................52
5.2 Lead System Evaluation ............................................52
5.3 Opening the Sterile Container ...................................53
5.4 Pocket Preparation ....................................................53
5.5 Lead to Device Connection .......................................54

Cardiac Airbag Technical Manual iii
5.6 Blind Plug Connection ...............................................55
5.7 Program the ICD........................................................56
5.8 Implant the ICD..........................................................56
5.9 Suggested Cardiac Airbag Implant Procedure ..........57
6. Follow-up Procedures ..................................................68
6.1 General Considerations.............................................68
6.2 Suggested Cardiac Airbag Follow-Up Procedure......68
6.3 Longevity....................................................................74
6.3.1 Standard ERI Method ........................................74
6.3.2 Treated VF Episode ERI Method.......................76
6.4 Explantation ...............................................................78
7. Technical Specifications ..............................................80
Appendix A...........................................................................85

iv Cardiac Airbag Technical Manual
Cardiac Airbag Specifications
Battery Voltage: 6.3 Volts
Maximum Shock Energy: 30 joules
Defibrillation Lead Ports Two DF-1 (3.2 mm)
Pacing Lead Ports One IS-1 (3.2 mm)
Dimension: 55 x 67 x 13 mm
Volume: 39 cc
Mass: 73 g
Housing Material: Titanium
Header Material: Epoxy Resin
Sealing Plug Material: Silicone
Battery Composition Li / MnO2

Cardiac Airbag Technical Manual 1
1. General
1.1 System Description
The Cardiac Airbag family of Implantable Cardioverter
Defibrillators (ICDs) detects and treats ventricular
tachyarrhythmias as well as provides rate adaptive bradycardia
pacing support. The ICDs are designed to collect diagnostic data
to aid the physician’s assessment of a patient’s condition and the
performance of the implanted device. The Cardiac Airbag ICDs
are specifically designed to have reduced complexity for implant
and follow-up, yet provide essential therapies for conversion of
life threatening ventricular tachyarrhythmias.
There are 10 programmable parameters to simplify the implant
procedure, and detailed diagnostic information is stored for up to
10 ventricular tachycardia (VT) episodes and 3 treated
ventricular fibrillation (VF) episodes. There are 30 minutes of
single-channel IEGM storage available to record spontaneous
and induced ventricular tachyarrhythmias. The Cardiac Airbag is
restricted to storage of diagnostic information up to and including
3 treated ventricular fibrillation episodes.
The Cardiac Airbag ICDs provide therapy for ventricular
tachyarrhythmias with programmable defibrillation therapy. The
ICDs provide high energy biphasic shocks with the first shock
having with programmable energies of 20 or 30 joules and up to
8 shocks per VF episode. The remaining 7 shocks in the
therapy progression are pre-set at 30 joules.
The Cardiac Airbag family of ICDs includes the following
members:
•Cardiac Airbag provides therapies for ventricular
tachyarrhythmias and single chamber rate adaptive
bradycardia pacing support.
•Cardiac Airbag-T is identical to the Cardiac Airbag with
the added functionality of BIOTRONIK’s Home
Monitoring system. The Home Monitoring System
enables automatic exchange of information about a
patient’s cardiac status from the implant to the physician
remotely.

2Cardiac Airbag Technical Manual
The Cardiac Airbag and Cardiac Airbag-T have two DF-1
defibrillation / cardioversion and one IS-1 pacing/sensing header
ports. IS-1 refers to the international standard whereby leads
and generators from different manufacturers are assured a basic
fit [Reference ISO 5841-3:1992]. DF-1 refers to the international
standard for defibrillation lead connectors [Reference ISO
11318:1993].
External devices that interact with and test the implantable
devices are also part of the ICD System. These external devices
include the TMS 1000
PLUS Tachyarrhythmia Monitoring System
and the EPR 1000
PLUS Programming and Monitoring System.
These programmers are used to interrogate and program the
ICDs. In addition, the programmer software is used to perform
the interrogation and programming of the ICDs during implant
and follow-up testing.
1.2 Indications and Usage
The Cardiac Airbag Implantable Cardioverter Defibrillators
(ICDs) are intended to provide ventricular defibrillation for
automated treatment of life-threatening ventricular arrhythmias.
1.3 Contraindications
Do not use the Cardiac Airbag Implantable Cardioverter
Defibrillators (ICDs) in patients:
•Whose ventricular tachyarrhythmias may have transient
or reversible causes including:
-acute myocardial infarction
-digitalis intoxication
-drowning
-electrocution
-electrolyte imbalance
-sepsis
-hypoxia
•Patients with incessant VT of VF
•Patients with unipolar pacemaker
•Patients whose only disorder is brady arrhythmia or
atrial arrhythmia

Cardiac Airbag Technical Manual 3
1.4 Warnings and Precautions
ATP (Anti-Tachycardia Pacing) – The Cardiac Airbag ICD
does not provide ATP therapy. Do not implant this ICD in
patients with documented ventricular tachycardias unless high
energy defibrillation is desired for treatment of the ventricular
arrhythmia.
MRI (Magnetic Resonance Imaging) - Do not expose a patient
dvertent arrhythmia
CD lead
ation Availability - Do not perform induction testing
program the VT/VF Detection and
in
1.4.1 Sterilization, Storage, and Handling
device’s
e-sterilize and re-implant explanted
to MRI device scanning. Strong magnetic fields may damage
the device and cause injury to the patient.
Electrical Isolation - To prevent ina
induction, electrically isolate the patient during the implant
procedure from potentially hazardous leakage currents.
Lead Systems - The use of another manufacturer’s I
system may cause potential adverse consequences such as
under sensing of cardiac activity and failure to deliver necessary
therapy.
Resuscit
unless an alternate source of patient defibrillation such as an
external defibrillator is readily available. In order to implant the
ICD system, it is necessary to induce and convert the patient’s
ventricular tachyarrhythmias.
Unwanted Shocks – Always
Therapy status to DISABLED prior to handling the device to
prevent the delivery of serious shocks to the patient or the
person handling the device during the implant procedure.
Rate-Adaptive Pacing – Use rate-adaptive pacing with care
patients unable to tolerate increased pacing rates.
Device Packaging - Do not use the device if the
packaging is wet, punctured, opened or damaged because the
integrity of the sterile packaging may be compromised. Return
the device to BIOTRONIK.
Re-sterilization - Do not r
devices.

4Cardiac Airbag Technical Manual
Storage (temperature) - Store the device between 5° to 55°C
(41° - 131° F) because temperatures outside this range could
damage the device.
Storage (magnets) - To avoid damage to the device, store the
device in a clean area, away from magnets, kits containing
magnets, and sources of electromagnetic interference (EMI).
Temperature Stabilization - Allow the device to reach room
temperature before programming or implanting the device
because temperature extremes may affect initial device function.
Use Before Date - Do not implant the device after the USE
BEFORE DATE because the device may have reduced
longevity.
1.4.2 Device Implantation and Programming
ected
ing of the high voltage
Blind Plug - A blind plug must be inserted and firmly conn
into any unused header port to prevent chronic fluid influx and
possible shunting of high energy therapy.
Capacitor Reformation - Infrequent charg
capacitors may extend the charge times of the ICD. The
capacitors may be reformed manually, or the ICD may be
programmed to reform the capacitors automatically. For further
information, please refer to Section 2.6.3, Capacitor Reforming.
Connector Compatibility - ICD and lead system compatibility
should be confirmed prior to the implant procedure. Consult
your BIOTRONIK representative regarding lead/pulse generator
compatibility prior to the implantation of an ICD system. For
further information, please refer to Appendix A.
ERI (Elective Replacement Indicator) - Upon reaching ERI, the
battery has sufficient energy remaining to continue monitoring for
at least three months and to deliver a minimum of six 30 joule
shocks. After this period, tachyarrhythmia detection and therapy
will proceed until EOS is declared. Bradycardia functions are
still active at programmed values until the battery voltage drops
below 3.0 volts.