Download Atlas™ II VR

™
Atlas II VR
Different people. Different needs. One ICD solution.
MODEL V-168
Implantable Cardioverter Defibrillator
70 x 50 x 14 mm
SPECIFICATIONS
Reduce the risk of inappropriate shocks
• The SenseAbility ™ feature with Decay Delay and Threshold Start provides the
flexibility to fine-tune to individual patient needs and helps eliminate oversensing of
T waves, fractionated QRS complexes, and other extraneous signals.
• The exclusive Morphology Discrimination feature helps reduce the risk of
inappropriate ICD shocks and promotes fast, accurate diagnosis and delivery of
therapy.
Help manage high DFTs without additional surgery
• Many drugs have been shown to raise defibrillation thresholds to potentially unsafe
levels.1 Our exclusive DeFT Response™ technology tools provide more clinically
proven, non-invasive options for managing high DFTs.
• Programmable pulse widths allow the user to tailor the shock to the individual
patient, making shocks more efficacious.2
• Four programmable tilt options are available, because no one tilt is optimal for
every patient.3
• The SVC shocking electrode can be activated or deactivated quickly and
non-invasively with the press of a button.
• 36J delivered energy provides unsurpassed energy for defibrillation.
• Together, these features may help to prevent additional surgical procedures.
Speed up implant time
• Our exclusive DC Fibber ™ VF induction has a documented 95.5% success rate for
inducing fibrillation on the first induction as compared with a 72.7% success rate
for Shock-on-T.4
1
2
3
4
Follow-up efficiently
• New fast telemetry speeds data from the device to the programmer.
• Redesigned programmer screens and new terminology help users move more
quickly through follow-up.
• There is an increase to 45 minutes of continuous, fully annotated stored
electrograms, including 0-32 seconds of pre-trigger information per electrogram.
Help patients forget that they have a device—
unless they need to be reminded
• Exclusive vibratory Patient Notifier may allow even patients with hearing problems
to be alerted to a low battery, lead-related complications and more.
Crystal E, Ovsyshcher Eli et al. Mexiletine related chronic defibrillation threshold elevation: case report and review of the literature. PACE 2002; 25 (Part
I):507-508.
McBride B, Clyne C et al. Does the use of beta-blocker of choice of beta-blocker impact the defibrillation threshold? Circulation 2004; Supplement III, 110
(17):III-625, 2907.
Nielsen T, Hamdan M et al. Effect of acute amiodarone loading on energy requirements for biphasic ventricular defibrillation. American Journal of
Cardiology; 88:446-448.
Mouchawar G, Kroll M, Val-Mejias JE et al. ICD waveform optimization: a randomized prospective, pair-sampled multicenter study. PACE 2000; 23 (Part
II):1992-1995.
Sweeney MO, Natale A, Volosin KJ et al. Prospective randomized comparison of 50%/50% versus 65%/65% tilt biphasic waveform on defibrillation in
humans. PACE 2001; 24:60-65.
Sharma AD, O'Neill PG, Fain E et al. Shock on T versus DC for induction of ventricular fibrillation: a randomized prospective comparison. 21st Annual
Scientific Session North American Society of Pacing and Electrophysiology (NASPE). Poster presentation published in meeting proceedings. Washington DC,
USA, May 2000.
Indications
The Atlas II and Atlas II+ systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated
treatment of life-threatening ventricular arrhythmias. The Atlas II HF and Atlas II+ HF CRT-Ds are also intended to resynchronize the right
and left ventricles in patients with congestive heart failure.
Contraindications
Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.
Warnings
The physician should be familiar with all components of the system and the material in this manual before beginning the procedure.
Ensure that a separate standby external defibrillator is immediately available. Avoid MRI devices because of the magnitude of the magnetic fields and the strength of the radiofrequency (RF) fields they produce. Do not implant the pulse generator if the acute defibrillation
lead impedance is less than 20 ohms or the lead impedance of chronic leads is less than 15 ohms. Damage to the device may result if
high-voltage therapy is delivered into an impedance less than 15 ohms. Avoid lithotripsy unless the therapy site is not near the pulse
generator and leads as it may damage the pulse generator. Avoid diathermy, even if the device is programmed off, as it may damage tissue around the implanted electrodes or may permanently damage the pulse generator.
Adverse Events
Implantation of the pulse generator system, like that of any other device, involves risks, some possibly life-threatening. These include but
are not limited to the following: acute hemorrhage/bleeding, air emboli, arrhythmia acceleration, cardiac or venous perforation, cardiogenic shock, cyst formation, erosion, exacerbation of heart failure, extrusion, fibrotic tissue growth, fluid accumulation, hematoma formation, histotoxic reactions, infection, keloid formation, myocardial irritability, nerve damage, pneumothorax, thromboemboli, venous occlusion. Other possible adverse effects include mortality due to: component failure, device-programmer communication failure, lead abrasion, lead dislodgment or poor lead placement, lead fracture, inability to defibrillate, inhibited therapy for a ventricular tachycardia, interruption of function due to electrical or magnetic interference, shunting of energy from defibrillation paddles, system failure due to ionizing
radiation. Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by: multiple counting of cardiac
events including T-waves, P-waves, or supplemental pacemaker stimuli. Among the psychological effects of device implantation are
imagined pulsing, dependency, fear of inappropriate pulsing, and fear that pulsing capability may be lost.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
Atlas™II VR Model V-168
Implantable Cardioverter Defibrillator
MODEL NUMBER
V-168
PHYSICAL SPECIFICATIONS
™
Volume (cc)
Weight (g)
Size (mm)
Defibrillation Lead Connections
Sense/Pace Lead Connections
High Voltage Can
38
77
70 x 50 x 14
DF-1
IS-1
Electrically active titanium can
PARAMETER
SETTINGS
Sensing/Detection
Auto Sensitivity Control
Programmable Threshold Start
Programmable Decay Delay
Detection Zones
Sudden Onset
Interval Stability
Morphology Discrimination (MD)
Automatic Template Update
Reconfirmation
ATP Pulse Width (ms)
DC Fibber™ Pulse Duration (sec)
Burst Fibber Cycle Length (ms)
Shock-on-T Voltage
Noninvasive Programmed
Stimulation (NIPS)
Ramp, Burst, Scan
Adaptive, Readaptive or Fixed
148-400 in increments of 4
1-15
2-20
On, Off
7.5 or 10.0; independently programmable from
Bradycardia and Post-Therapy Pacing
1.0 or 1.9; independently programmable from
Bradycardia and Post-Therapy Pacing
0.5-5.0
20-100
50-830 V [0.1-36J (Delivered)]
2-20 stimuli with up to three extrastimuli
Electrograms and Diagnostics
Stored Electrograms
Automatic sensitivity adjustment for ventricular events
(Post-Sensed, Ventricular) 50, 62.5, 75, 100%;
(Post-Paced, Ventricular) Auto, 0.2-3.0 mV in 0.1
mV increments
(Post-Sense, Ventricular) 0, 30, 60, 95, 125, 160, 190,
220 ms;
(Post-Pace, Ventricular) Auto, 0, 30, 60, 95, 125, 160,
190, 220 ms
VT-1, VT-2, VF
On, Off, Passive
On, On with SIH (Sinus Interval History),
Off, Passive
On, Off, Passive
Off, 8 hours, 1 day, 3 days, 7 days, 14 days, 30 days
Continuous sensing during charging
Antitachycardia Pacing Therapy
ATP Configurations
Burst Cycle Length
Min. Burst Cycle Length (ms)
Number of Bursts
Number of Stimuli
Extrastimuli per Burst
ATP Pulse Amplitude (V)
Device Testing/Induction Methods
Therapy Summary
Episodes
Lifetime Diagnostics
Event Histogram
Heart Rate Histogram
Sensor Histogram
Real-Time Measurements (RTM)
Up to 45 minutes including up to 32 seconds
programmable pre-trigger data per electrogram;
triggers include diagnosis, therapy, PC
shock delivery, noise reversion, magnet reversion,
and morphology template verification
Diagram of therapies delivered
Directory listing of up to 60 episodes with access
to more details including stored electrograms
History of bradycardia events and deviceinitiated charging
Bar graph of sensed and paced event sequences
Bar graph of sensed and paced rates
Information regarding sensor activity
Pacing lead impedances, unloaded battery voltage,
signal amplitudes and RTM trends
Patient Notifiers
Device at ERI
Charge Time Limit Reached
Possible HV Circuit Damage
Device Reset
Ventricular Lead Impedance (out of range)
Entry into Backup VVI Mode
Vibration Duration
Number of Vibrations per Notification
Number of Notifications
Time Between Notifications
Off, On
Off, On
Off, On
Off, On
Off, On
On
2, 4, 6, 8, 10, 12, 14, 16 s
1, 2
1-16
10, 22 hours
High Voltage Therapy
Maximum Energy/Voltage
High Voltage Output Mode
Waveform
RV Polarity
Electrode Configuration
42J (Stored)/ 830 volts /36J (Delivered)
Programmable Pulse Width, Programmable Tilt
Biphasic, Monophasic
Cathode (-), Anode (+)
RV to Can, RV to SVC/Can
Bradycardia Pacing
Permanent Modes
Temporary Modes
Rate-Adaptive Sensor
Base Rate (min-1)
Rest Rate (min-1)
Maximum Sensor Rate (min-1)
Pulse Amplitude (Ventricular) (V)
Pulse Width (Ventricular) (ms)
Hysteresis Rate (min-1)
Rate Hysteresis with Search
Rate Responsive Ventricular Refractory
VVI(R), Pacer Off
VVI, VOO
On, Off, Passive
40-100
Off, 35-95
80-150
0.25-7.5
0.05, 0.1-1.5
Off, 35-95
On, Off
Off, Low, Medium, High
Post-Therapy Pacing (Independently programmable from Bradycardia and ATP)
Post-Shock Pacing Mode
Post-Shock Base Rate (min-1)
Post-Shock Pacing Duration
Post-Shock Ventricular Pacing Amplitude (V)
Post-Shock Pacing Pulse Width (ms)
Cardiac Rhythm
Management Division
15900 Valley View Court
Sylmar, CA 91342 USA
888 SJM-CRMD
818 362-6822
818 362-7182 Fax
www.sjm.com
Off, VVI
35-100 in increments of 5
Off, 30 sec, 1, 2.5, 5, 7.5, 10 min
0.25 to 7.5, 10.0
0.05, 0.1-1.5
St. Jude Medical AB
Veddestavägen 19
SE-175 84 Järfälla
SWEDEN
+46 8 474 4000
+46 8 760 9542 Fax
Ordering No. G0XXX 060605
CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER
OF A PHYSICIAN.
Consult the User’s Manual for information on indications, contraindications, warnings and precautions.
Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical, or one of its subsidiaries.
© 2006 St. Jude Medical Cardiac Rhythm Management Division. All rights reserved.