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Cardiac Rhythm Management Division August 2010: U.S. Product Catalog

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0% found this document useful (0 votes)

82 views

Cardiac Rhythm Management Division August 2010: U.S. Product Catalog

Uploaded by

Abid Khan

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

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Cardiac Rhythm Management Division

U.S. Product Catalog

August 2010
Table of Contents

Cardiac Resynchronization Therapy (CRT) Devices

CRT Defibrillator
Promote® Accel ................................................................................................................................CRT1
Promote® Plus ..................................................................................................................................CRT3
Unify™ ..............................................................................................................................................CRT5

CRT Pacemaker
Anthem® RF .....................................................................................................................................CRT7

Left-Heart Leads/Implant Tools

CPS Direct® SL .................................................................................................................................LHL1
CPS Direct® SL II ..............................................................................................................................LHL3
CPS Universal Slitter .........................................................................................................................LHL5
QuickFlex® . ......................................................................................................................................LHL6
QuickFlex® µ......................................................................................................................................LHL8
QuickSite® ........................................................................................................................................LHL10

Implantable Cardioverter Defibrillator (ICD) Devices

Dual-Chamber
Current Accel™ DR.............................................................................................................................ICD1
Fortify™ DR........................................................................................................................................ICD3
Single-Chamber
Current Accel™ VR.............................................................................................................................ICD5
Current® Plus VR...............................................................................................................................ICD7
Fortify™ VR........................................................................................................................................ICD9

Defibrillation Leads
Durata® ............................................................................................................................................DL1

Pacemakers

Dual-Chamber
Accent® DR ......................................................................................................................................PM1
Accent® DR RF . ...............................................................................................................................PM3
Zephyr® DR ......................................................................................................................................PM5
Zephyr® XL DR..................................................................................................................................PM7
Pacemakers

Single-Chamber
Accent® SR . .....................................................................................................................................PM9
Accent® SR RF .................................................................................................................................PM11
Microny® II SR+ ................................................................................................................................PM13
Microny® K SR . ................................................................................................................................PM15

External Pulse Generators

Dual-Chamber
External Pulse Generator (DDD) ........................................................................................................EPG1

Single-Chamber
External Pulse Generator (SSI) ..........................................................................................................EPG2

Pacing Leads

Bipolar/Unipolar
Tendril® SDX .....................................................................................................................................PL1
Tendril® ST Optim® ...........................................................................................................................PL3
Tendril® STS .....................................................................................................................................PL5

External Equipment

Merlin® Pacing System Analyzer . ......................................................................................................EE1

Merlin® Patient Care System .............................................................................................................EE2
Cardiac Resynchronization
Therapy (CRT) Devices
Cardiac Resynchronization Therapy (CRT) Devices

Promote Accel®
Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Product Highlights
n The LV, RV, and Atrial Capture Confirmation features ensure capture of the
myocardium in response to pacing stimuli in the left ventricle, right ventricle and right
atrium. LVCap™, RVCap® and ACap® Confirm help to ensure patient safety and therapy
delivery by automatically monitoring and adjusting capture thresholds according to
changing patient needs.
n Vibratory Patient Notifier enables patients with hearing problems to be alerted to a low
battery, lead-related complications and more.
n Advanced Biventricular Pacing options
– VectSelect® programmable LV pulse configuration (LV ring-RV coil, LV tip-RV coil or
LV bipolar) may be adjusted noninvasively via the programmer.
– Triggered Pacing with BiV Trigger Mode helps maintain a high percentage of BiV
pacing by triggering pacing in both the left and right ventricles in response to a
sensed ventricular event.
– Negative AV hysteresis with search promotes ventricular pacing by automatically
reducing the AV delay when intrinsic activity is present, thereby promoting a high
degree of ventricular pacing.
n The optional DF4 connector is designed to simplify implants by streamlining
defibrillation connections into a single terminal pin and reducing the number
of set screws.
n TailoredTherapy™ features designed to customize treatment to each patient’s unique
needs, including QuickOpt® Timing Cycle Optimization, which provides quick
and effective optimization for more patients at the push of a button, VectSelect®
programmable LV pulse configuration and DeFT Response® Technology, which
provides more noninvasive programming flexibility in the management of DFTs.
n InvisiLink® wireless telemetry, in conjunction with the Merlin@home® transmitter and
Merlin.net® Patient Care Network (PCN), allows for daily remote monitoring and follow-up.
n AT/AF Alerts notify patients and their clinics when a programmed AT/AF threshold
or continuous episode duration has been exceeded, or when a high ventricular rate
accompanies the AT/AF episode.

Ordering Information
Contents: Cardiac pulse generator

Model Dimensions Connector Connector

Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillation Sense/Pace
CD3215-36 81 x 50 x 14 82 43 DF-1 IS-1
CD3215-36Q 75 x 50 x 14 82 42 DF4 IS-1, DF4

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page CRT1
Cardiac Resynchronization Therapy (CRT) Devices

Promote Accel®
Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Product Specifications
PHYSICAL SPECIFICATIONS Programmable Rate and Off; Base Rate (ppm); Rest Rate (ppm); Maximum Tracking Rate (ppm);
Delay Parameters Maximum Sensor Rate (ppm); Paced AV Delay (ms); Sensed AV Delay (ms);
Models CD3215-36 CD3215-36Q
Rate Responsive AV Delay; Hysteresis Rate (ppm); Rate Hysteresis with Search;
Telemetry RF RF
Maximum Trigger Rate
Delivered/Stored Energy (J) 36/42 36/42
Auto Mode Switch (AMS) Off; DDI(R); DDT(R); VVI(R); VVT(R)
Volume (cc) 43 42
Atrial Tachycardia Detection Rate (ppm) 110-300
Weight (g) 82 82
AMS Base Rate (ppm) 40; 45; ... 135
Size (mm) 81 x 50 x 14 75 x 50 x 14
Auto PMT Detection/Termination Atrial Pace; Off; Passive
Defibrillation Lead Connections DF-1 DF4
Rate Responsive PVARP/VREF Off; Low; Medium; High
Sense/Pace Lead Connections IS-1 IS-1; DF4
Ventricular Intrinsic Preference (VIP ®) Off; 50-200 (50-150 in increments of 25; 160-200 in increments of 10)
High-Voltage Can Electrically active titanium can Electrically active titanium can
LVCap™ Confirm, RVCap® Confirm Setup; On; Monitor; Off
PARAMETERS Settings ACap® Confirm On; Monitor; Off
Biventricular Pacing Post-Therapy Pacing (independently programmable from Bradycardia and ATP )

V. Triggering (BiV Trigger Mode) On; Off Post-Shock Pacing Mode Off; AAI; VVI; DDI; DDD
QuickOpt® Timing Cycle Optimization Sensed/paced AV delay; Interventricular Pace delay Post-Shock Base Rate (ppm) 30-100 in increments of 5
V-V Timing Simultaneous*; RV First; LV First Post-Shock Pacing Duration (min) Off; 0.5; 1; 2.5; 5; 7.5; 10
Interventricular Pace Delay (ms) RV First 10-80 / LV First 15-80 in increments of 5 Device Testing/Induction Methods
Ventricular Sensing RV only (not programmable)
Ventricular Pacing Chamber RV only; biventricular DC Fibber™ Pulse Duration (sec) 0.5-5.0
Negative AV Hysteresis/Search (ms) Off; -10 to -120 Burst Fibber Cycle Length (ms) 20-100
Shortest AV Delay (ms) 25-120 Noninvasive Programmed 2-25 stimuli with up to 3 extrastimuli
VectSelect ® LV Pulse Configuration LV tip to RV coil; LV bipolar; LV ring to RV coil Stimulation (NIPS)

AF Management Patient Notifiers

AF Suppression™ Pacing On; Off Programmable Notifiers (On; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage;
No. of Overdrive Pacing Cycles 15-40 in steps of 5 Atrial Lead Impedance Out of Range; RV Lead Impedance Out of Range;
Maximum AF Suppression Rate (ppm) 80-150 LV Lead Impedance Out of Range; High-Voltage Lead Impedance
Out of Range; AT/AF Burden; V Rate During AT/AF; Backup VVI;
Sensing/Detection Long AT/AF Episode
SenseAbility® Technology Automatic Sensitivity Control adjustment for ventricular events Device Parameter Reset On
Threshold Start (Post-Sensed; Atrial) 50; 62.5; 75; 100%; (Post-Paced; Atrial) 0.2-3.0 mV; Entry into Backup VVI Mode On
(Post-Sensed; Ventricular) 50; 62.5; 75; 100%; (Post-Paced; Ventricular) Vibration Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
Auto; 0.2-3.0 mV Number of Vibrations per Notification 2
Decay Delay (Post-Sensed/Post-Paced; Atrial/Ventricular) 0-220; Number of Notifications 1-16
(Post-Paced; Ventricular) Auto Time Between Notifications (hours) 10; 22
Ventricular Sense Refractory (ms) 125; 157 Electrograms and Diagnostic
Detection Zones VT-1; VT-2; VF
SVT Discriminators AV Rate Branch; Sudden Onset; Interval Stability; Morphology Stored Electrograms Up to 45 minutes including up to 1 minute programmable pre-trigger
Discrimination (MD) with Manual or Automatic Template Update data per VT/VF diagnosis/detection electrograms; triggers include:
Reconfirmation Continuous sensing during charging detection or diagnosis and therapy; atrial episode; PMT termination;
PC shock delivery; noise reversion; magnet reversion; and morphology
Antitachycardia Pacing Therapy template verification
ATP Configurations Ramp; Burst; Scan; 1 or 2 schemes per zone Therapy Summary Diagram of therapies delivered
Burst Cycle Length Readaptive or Fixed Episodes Summary Directory listing of up to 60 episodes with access to more details including
Min. Burst Cycle Length (ms) 150-400 in increments of 5 stored electrograms
Number of Bursts/Stimuli 1-15 with 2-20 Stimuli Lifetime Diagnostics History of bradycardia events and device-initiated charging
Add Stimuli per Burst On; Off AT/AF Burden Trend Trend data and counts
Ventricular HV Lead Impedance Trend Multi-Vector Trend Data
High-Voltage Therapy Sense and Capture Diagnostics Atrial and Ventricular Signal Amplitude trends and electrogram from last
High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt measurement, Atrial, RV and LV Capture Threshold trends and electrogram
Waveform Biphasic; Monophasic from last measurement
RV Polarity Cathode (-); Anode (+) Histograms Event Histogram; AV Interval Histogram; Mode Switch Duration Histogram;
Electrode Configuration RV to Can; RV to SVC/Can Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Ventricular
Heart Rate Histogram; AT/AF Burden; Exercise and Activity Trending;
Bradycardia Pacing V Rates during AMS and AT/AF
Permanent Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); DOO(R); VOO(R); AOO(R) PMT Data Information regarding PMT detections
Temporary Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); AAT(R); DOO(R); VOO(R); Real-Time Measurements (RTM) Pacing lead impedances; high-voltage lead impedances; unloaded battery
AOO(R) voltage; and signal amplitudes
Rate-Adaptive Sensor On; Off; Passive *LV first with 10 ms interventricular delay.

Indications and Usage: The Promote Accel pulse generators are intended to provide ventricular Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system,
antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism,
ventricular arrhythmias. AF Suppression pacing is indicated for suppression of paroxysmal or persistent allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of
atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest
indicated for an ICD, the Promote Accel pulse generators are also intended to provide a reduction of the wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection,
symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage,
remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section pneumothorax, shunting current or insulating myocardium during defibrillation with internal, or external
included in the Merlin® Patient Care System [PCS] on-screen help) and have a left ventricular ejection paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion,
fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical
right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial management, may develop psychological intolerance to an ICD or CRT-D system that may include the
fibrillation and have NYHA Class II or III heart failure. following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious,
fear of losing shock capability, imagined shocking (phantom shock).
Contraindications: Contraindications for use of the pulse generator system include ventricular
tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and
imbalance, or acute myocardial infarction. potential adverse events.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Promote® Plus
Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Product Highlights
n The DF4 connector is designed to simplify implants by streamlining
defibrillation connections into a single terminal pin and reducing the number
of set screws.
n Triple Redundancy Safety Platform is designed to minimize risk and increase
security and patient comfort through multiple hardware and software system
safeguards.
n Vibratory Patient Notifier enables patients with hearing problems to be alerted
to a low battery, lead-related complications and more.
n TailoredTherapy™ features designed to customize treatment to each patient’s
unique needs, including QuickOpt® Timing Cycle Optimization, which provides
quick and effective optimization for more patients at the push of a button,
VectSelect® programmable LV pulse configuration and DeFT Response®
Technology that allows more noninvasive programming flexibility in the
management of DFTs.
n AT/AF Alerts notify patients and their clinics when a programmed AT/AF
threshold or continuous episode duration has been exceeded, or when a
high ventricular rate accompanies the AT/AF episode.

Ordering Information
Contents: Cardiac pulse generator

Model Dimensions Connector Connector

Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillation Sense/Pace
CD3211-36Q 75 x 50 x 14 82 42 DF4 IS-1

Indications and Usage: The Promote ® pulse generators are intended to provide ventricular Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system,
antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism,
ventricular arrhythmias. AF Suppression pacing is indicated for suppression of paroxysmal or persistent allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of
atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest
indicated for an ICD, the Promote pulse generators are also intended to provide a reduction of the wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection,
symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage,
remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section pneumothorax, shunting current or insulating myocardium during defibrillation with internal, or external
included in the Merlin Patient Care System [PCS] on-screen help) and have a left ventricular ejection paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion,
fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical
right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial management, may develop psychological intolerance to an ICD or CRT-D system that may include the
fibrillation and have NYHA Class II or III heart failure. following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious,
fear of losing shock capability, imagined shocking (phantom shock).
Contraindications: Contraindications for use of the pulse generator system include ventricular
tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
imbalance, or acute myocardial infarction. adverse events.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Promote® Plus
Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Product Specifications
PHYSICAL SPECIFICATIONS Post-Therapy Pacing (Independently programmable from Bradycardia and ATP )
Model CD3211-36Q
Telemetry RF Post-Shock Pacing Mode Off, AAI, VVI, DDI, or DDD
Delivered Energy 36 J Post-Shock Base Rate (ppm) 30-100 in increments of 5
Volume (cc) 42 Post-Shock Pacing Duration (min) Off, 0.5, 1, 2.5, 5, 7.5, or 10
Weight (g) 82
Size (mm) 75 x 50 x 14 Device Testing/Induction Methods
Defibrillation Lead Connections DF4
Sense/Pace Lead Connections IS-1 DC Fibber™ Pulse Duration (sec) 0.5-5.0
High-Voltage Can Electrically active titanium can Burst Fibber Cycle Length (ms) 20-100
Noninvasive Programmed
Stimulation (NIPS) 2-25 stimuli with up to three extrastimuli
PARAMETER SETTINGS
V. Triggering (BiV Trigger Mode) On, Off
Patient Notifiers
QuickOpt ® Timing Cycle Optimization Sensed/paced AV delay, Interventricular Pace delay
Ventricular Pacing Simultaneous*, RV First, LV First, RV Only
Programmable Notifiers (On, Off) Device at ERI, Charge Time Limit Reached, Possible HV Circuit
Interventricular Pace Delay (ms) RV First 10-80 / LV First 15-80 in increments of 5
Damage, Atrial Lead Impedance Out of Range, Right Ventricular Lead
Ventricular Sensing RV only (not programmable)
Impedance Out of Range, AT/AF Burden, Backup VVI, HV Lead
Ventricular Pacing Chamber RV only, biventricular
Impedance Out of Range, LV Lead Impedance Out of Range
Negative AV Hysteresis/Search (ms) Off, -10, -20, -30, -40
Device Parameter Reset On
Rate Responsive AV Delay Off, Low, Medium, High
Entry into Backup VVI Mode On
VectSelect ® LV Pulse Configuration LV tip to RV coil, LV bipolar, LV ring to RV coil
Vibration Duration (sec) 2, 4, 6, 8, 10, 12, 14, 16
Number of Vibrations per Notification 2
AF Management Number of Notifications 1-16
Time Between Notifications (hours) 10, 22
AF Suppression™ Pacing On, Off
No. of Overdrive Pacing Cycles 15-40 in steps of 5
Electrograms and Diagnostics
Maximum AF Suppression Rate 80-150 ppm
Stored Electrograms Up to 45 minutes including up to one minute programmable pre-
Sensing/Detection trigger data per VT/VF diagnosis/detection electrograms; triggers
include diagnosis, therapy, atrial episode, PMT termination, PC shock
SenseAbility® Technology Automatic Sensitivity Control adjustment for atrial and delivery, noise reversion, magnet reversion, and morphology template
ventricular events verification
Threshold Start (Post-Sensed, Atrial) 50; 62.5; 75; 100%; (Post-Paced, Atrial) Therapy Summary Diagram of therapies delivered
0.2-3.0 mV; (Post-Sensed, Ventricular) 50; 62.5; 75; 100%; (Post- Episodes Summary Directory listing of up to 60 episodes with access to more details
Paced, Ventricular) Auto, 0.2-3.0 mV including stored electrograms
Decay Delay (Post-Sense/Post-Pace, Atrial/Ventricular) 0-220; Lifetime Diagnostics History of bradycardia events and device-initiated charging
(Post-Pace Ventricular) Auto AT/AF Burden Trend Trend data and counts
Ventricular Sense Refractory (ms) 125, 157 Ventricular HV Lead Impedance Trend Multi-Vector Trend Data
Detection Zones VT-1, VT-2, VF Histograms Event Histogram, AV Interval Histogram, Mode Switch Duration
SVT Discriminators AV Rate Branch, Sudden Onset, Interval Stability, Morphology Histogram, Peak Filtered Rate Histogram, Atrial Heart Rate Histogram,
Discrimination (MD) with Manual or Automatic Template Update Ventricular Heart Rate Histogram, AT/AF Burden, Exercise and Activity
Reconfirmation Continuous sensing during charging Trending, V Rates During AMS
PMT Data Information regarding PMT detections
Antitachycardia Pacing Therapy Real-Time Measurements (RTM) Pacing lead impedances,high-voltage lead impedances, unloaded
battery voltage, and signal amplitudes
ATP Configurations Ramp, Burst, Scan; 1 or 2 schemes per zone
Burst Cycle Length Readaptive or Fixed
Min. Burst Cycle Length (ms) 150-400 in increments of 5 *LV first with 10 ms interventricular delay.
Number of Bursts/Stimuli 1-15 with 2-20 Stimuli
Add Stimuli per Burst On, Off

High-Voltage Therapy

High-Voltage Output Mode Fixed Pulse Width, Fixed Tilt

Waveform Biphasic, Monophasic
RV Polarity Cathode (-), Anode (+)
Electrode Configuration RV to Can, RV to SVC/Can

Bradycardia Pacing

Permanent Modes Off, DDD(R), DDT(R), DDI(R), VVT(R), VVI(R), AAI(R), DOO(R),
VOO(R), AOO(R)
Temporary Modes Off, DDD(R), DDT(R), DDI(R), VVT(R), VVI(R), AAI(R), AAT, DOO, VOO,
AOO, AAT(R)
Rate-Adaptive Sensor On, Off, Passive
Programmable Rate and Off, Base Rate (ppm), Rest Rate (ppm),
Delay Parameters Maximum Tracking Rate, (ppm)
Maximum Sensor Rate (ppm), Paced AV Delay (ms), Sensed AV Delay
(ms), Rate Responsive AV Delay, Pulse Amplitude (Atrial, RV and LV)
(V), Pulse Width (Atrial, RV and LV) (ms), Hysteresis Rate (ppm), Rate
Hysteresis with Search
Auto Mode Switch (AMS) Off, DDI(R), DDT(R), VVI(R), VVT(R)
Atrial Tachycardia Detection Rate (ppm) 110-300
AMS Base Rate 40, 45, ...135
Auto PMT Detection/Termination Atrial Pace, Off, Passive
Rate Responsive PVARP/VREF Off, Low, Medium, High
Ventricular Intrinsic Preference (VIP ®) Off, 50-200 (50-150 in increments of 25;
160-200 in increments of 10)

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Unify™
Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Product Highlights
n Smallest footprint of any HV device available.
n Vibratory Patient Notifier enables patients with hearing problems to be alerted
to a low battery, lead-related complications and more.
n Advanced Biventricular Pacing options:
– VectSelect® programmable LV pulse configuration (LV ring-RV coil, LV tip-RV
coil or LV bipolar) may be adjusted noninvasively via the programmer.
– Triggered Pacing with BiV Trigger Mode helps maintain a high percentage
of BiV pacing by triggering pacing in both the left and right ventricles in
response to a sensed ventricular event.
– Negative AV hysteresis with search promotes ventricular pacing by
automatically reducing the AV delay when intrinsic activity is present,
thereby promoting a high degree of ventricular pacing.
n Unique 40 J delivered energy Safety Shock option can provide a greater
DFT safety margin.
n The Low Frequency Attenuation filter is designed to enhance sensing
performance and may reduce the possibility of oversensing T waves.
n QHR® chemistry battery provides greater capacity for enhanced longevity and
stable charge times.
n The addition of antitachycardia pacing (ATP) while charging and prior
to charging in the VF zone further extends the programming options for
terminating tachyarrhythmias without a high voltage shock.
n The optional DF4 connector is designed to simplify implants by streamlining
defibrillation connections into a single terminal pin and reducing the number
of set screws.
n TailoredTherapy™ features designed to customize treatment to each patient’s
unique needs, including QuickOpt® Timing Cycle Optimization, which provides
quick and effective optimization for more patients at the push of a button,
VectSelect® programmable LV pulse configuration and DeFT Response®
Technology which provides more noninvasive programming flexibility in the
management of DFTs.

QHR is a registered trademark of Greatbatch Medical.

Ordering Information
Contents: Cardiac pulse generator

Model Dimensions Connector Connector

Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillation Sense/Pace
CD3231-40 79 x 40 x 14 78 36 DF1 IS-1
CD3231-40Q 73 x 40 x 14 77 36 DF4 DF4, IS-1

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Unify™
Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Product Specifications
PHYSICAL SPECIFICATIONS Bradycardia Pacing
Models CD3231-40 CD3231-40Q
Permanent Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R)
Telemetry RF RF
Temporary Modes Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); AAT; DOO; VOO; AOO
Delivered/Stored Energy (J) 40/45 40/45
Rate-Adaptive Sensor On; Off; Passive
Volume (cc) 36 36
Programmable Rate and Off; Base Rate (ppm); Rest Rate (ppm); Maximum Tracking Rate (ppm)
Weight (g) 78 77
Delay Parameters Maximum Sensor Rate (ppm); Paced AV Delay (ms); Sensed AV Delay (ms);
Size (mm) 79 x 40 x 14 73 x 40 x 14
Rate Responsive AV Delay; Hysteresis Rate (ppm); Rate Hysteresis with Search
Defibrillation Lead Connections DF-1 DF4
Auto Mode Switch (AMS) Off; DDI(R); DDT(R); VVI(R); VVT(R)
Sense/Pace Lead Connections IS-1 DF4, IS-1
Atrial Tachycardia Detection Rate 110-300
High-Voltage Can Electrically active titanium can Electrically active titanium can
AMS Base Rate 40; 45; ... 135
PARAMETERS Settings Auto PMT Detection/Termination Atrial Pace on PMT; Off; Passive
Biventricular Pacing Rate Responsive PVARP/VREF Off; Low; Medium; High
Ventricular Intrinsic Preference (VIP ) Off; 50-200 (50-150 in increments of 25; 160-200 in increments of 10)
®

V. Triggering (BiV Trigger Mode) On; Off LVCap Confirm, RVCap Confirm
™ ®
Setup; On; Monitor; Off
QuickOpt ® Timing Cycle Optimization Sensed/paced AV delay; interventricular pace delay ACap® Confirm On; Monitor; Off
V-V Timing Simultaneous*; RV First; LV First
Post-Therapy Pacing (independently programmable from Bradycardia and ATP)
Interventricular Pace Delay (ms) RV First 10-80 / LV First 15-80 in increments of 5
Ventricular Sensing RV only (not programmable) Post-Shock Pacing Mode Off; VVI; DDI; DDD; AAI
Ventricular Pacing Chamber RV only; biventricular Post-Shock Base Rate (ppm) 30-100 in increments of 5
Negative AV Hysteresis/Search (ms) Off; -10 to -120 Post-Shock Pacing Duration (min) Off; 0.5; 1; 2.5; 5; 7.5; or 10
Shortest AV Delay (ms) 25-120
Device Testing/Induction Methods
VectSelect ® LV Pulse Configuration LV tip to RV coil; LV bipolar; LV ring to RV coil
DC Fibber™ Pulse Duration (sec) 0.5-5.0
AF Management
Burst Fibber Cycle Length (ms) 20-100
AF Suppression™ Pacing On; Off Noninvasive Programmed 2-25 stimuli with up to 3 extrastimuli
No. of Overdrive Pacing Cycles 15-40 in steps of 5 Stimulation (NIPS)
Maximum AF Suppression Rate 80-150 ppm
Patient Notifiers
Sensing/Detection
Programmable Notifiers (On; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage;
SenseAbility® Technology Automatic Sensitivity Control adjustment for atrial ventricular events Atrial Lead Impedance Out of Range; Ventricular Lead Impedance Out
Low Frequency Attenuation On; Off of Range; High-Voltage Lead Impedance Out of Range; AT/AF Burden;
Threshold Start (Post-Sensed; Atrial) 50; 62.5; 75; 100%; (Post-Paced; Atrial) 0.2-3.0 mV; V Rate During AT/AF; Long AT/AF Episode
(Post-Sensed; Ventricular) 50; 62.5; 75; 100%; (Post-Paced; Ventricular) Device Parameter Reset On
Auto; 0.2-3.0 mV Entry into Backup VVI Mode On
Decay Delay (Post-Sensed/Post-Paced; Atrial/Ventricular) 0-220 Vibration Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
Ventricular Sense Refractory (ms) 125; 157 Number of Vibrations per Notification 2
Detection Zones VT-1; VT-2; VF Number of Notifications 1-16
SVT Discriminators AV Rate Branch; Sudden Onset; Interval Stability; Morphology Time Between Notifications (hours) 10; 22
Discrimination (MD) with Manual or Automatic Template Update Electrograms and Diagnostic
Reconfirmation Continuous sensing during charging
Stored Electrograms Up to 45 minutes including up to 1 minute programmable pre-trigger
Antitachycardia Pacing Therapy data per VT/VF diagnosis/detection electrograms; triggers include
ATP Configurations Ramp; Burst; Scan; 1 or 2 schemes per VT zone diagnosis; therapy; atrial episode; PMT termination; PC shock delivery;
ATP in VF Zone ATP While Charging; ATP Prior to Charging; Off noise reversion; magnet reversion; and morphology template verification
ATP Upper Rate Cutoff 150-300 bpm Therapy Summary Diagram of therapies delivered
Burst Cycle Length Adaptive; Readaptive or Fixed Episodes Summary Directory listing of up to 60 episodes with access to more details including
Min. Burst Cycle Length (ms) 150-400 in increments of 5 stored electrograms
Number of Bursts 1-15 Lifetime Diagnostics History of bradycardia events and device-initiated charging
Number of Stimuli 2-20 Ventricular HV Lead Impedance Trend Multi-Vector Trend Data
Add Stimuli per Burst On; Off Histograms Event Histogram; AV Interval Histogram; Mode Switch Duration Histogram;
Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Ventricular Heart
High-Voltage Therapy Rate Histogram; AT/AF Burden; Exercise and Activity Trending; V Rates During AMS
High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Real-Time Measurements (RTM) Pacing lead impedances; high-voltage lead impedances;
Waveform Biphasic; Monophasic and signal amplitudes
RV Polarity Cathode (-); Anode (+)
Electrode Configuration RV to Can; RV to SVC/Can
QHR is a registered trademark of Greatbatch Medical.
*LV first with 10 ms interventricular delay.

Indications for Use: Unify pulse generators are intended to provide ventricular antitachycardia pacing Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system,
and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism,
Suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of
with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, Unify pulse heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest
generators are also intended to provide a reduction of the symptoms of moderate to severe heart failure wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection,
(NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage,
medical therapy (as defined in the clinical trials section included in the Merlin® Patient Care System [PCS] pneumothorax, shunting current or insulating myocardium during defibrillation with internal, or external
on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion,
QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical
nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure. management, may develop psychological intolerance to an ICD or CRT-D system that may include the
following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious,
Contraindications: Contraindications for use of the pulse generator system include ventricular fear of losing shock capability, imagined shocking (phantom shock).
tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte
imbalance, or acute myocardial infarction. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
adverse events.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Anthem® RF
Cardiac Resynchronization Therapy Pacemaker

Product Highlights
n InvisiLink® Wireless Telemetry, in conjunction with the Merlin@home®
transmitter and Merlin.net® Patient Care Network (PCN), allows for daily
remote monitoring and follow-up.
n AT/AF Alerts can be programmed to notify patients and/or their clinics when
a programmed AT/AF threshold or continuous episode duration has been
exceeded, or when a high ventricular rate accompanies the AT/AF episode.
n E xclusive AF Suppression™ algorithm is clinically proven to suppress episodes
of paroxysmal and persistent AF.
n AT/AF Burden Trend provides a graphical representation of the percentage of
time in AT/AF and the number of AT/AF episodes in the previous 52 weeks.
n Up to 14 minutes of stored electrograms help identify key intrinsic and
pacemaker-related events and simplify the diagnosis of complex ECG rhythms
associated with heart failure.

Ordering Information
Contents: Cardiac pulse generator

Model Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector

PM3210 58 x 52 x 6 25 13.7 1
IS-1

Indications: Implantation of Anthem and Anthem RF devices is indicated for: maintaining synchrony of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively
of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction,
fibrillation and have NYHA Class II or III heart failure, the reduction of the symptoms of moderate to severe or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial
heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction.
medical therapy, and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, Atrial Fibrillation. Anthem devices are contraindicated in patients having chronic atrial fibrillation or
implantation of Accent™, Accent RF, Anthem, and Anthem RF devices is indicated in one or more of the intermittent atrial fibrillation that does not terminate. For specific contraindications associated with
following permanent conditions: syncope, presyncope, fatigue, disorientation, or any combination of individual modes, refer to the programmer’s on-screen help.
those symptoms. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and
for those who would benefit from increased stimulation rates concurrent with physical activity. Dual- Potential Adverse Events: The following are potential complications associated with the use of any
Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic, symptomatic pacing system: air embolism, body rejection phenomena, cardiac tamponade or perforation, hematoma,
second- and third-degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle bleeding hematoma, seroma, formation of fibrotic tissue, local tissue reaction, inability to interrogate
branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for or program due to programmer or device malfunction, infection/erosion, interruption of desired pulse
patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular generator function due to electrical interference, either electromyogenic or electromagnetic, lead
Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare malfunction due to conductor fracture or insulation degradation, loss of capture or sensing due to lead
episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression dislodgement or reaction at the electrode/tissue interface, loss of desired pacing and/or sensing due
is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to
more of the above pacing indications. insulation), loss of normal device function due to battery failure or component malfunction, pacemaker
migration or pocket erosion, pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation,
Contraindications: Implanted Cardioverter-Defibrillator (ICD). Devices are contraindicated in patients pneumothorax/hemothorax, device migration and pocket erosion, endocarditis, excessive bleeding,
with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients induced atrial or ventricular arrhythmias, myocardial irritability, pericardial effusion, pericardial rub,
who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An pulmonary edema, rise in threshold and exit block, valve damage, cardiac/coronary sinus dissection,
appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation cardiac/coronary sinus perforation, coronary sinus or cardiac vein thrombosis.
rate tolerated by the patient. AF Suppression stimulation is not recommended in patients who cannot
tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that adverse events.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Anthem® RF
Cardiac Resynchronization Therapy Pacemaker

Product Specifications
PHYSICAL SPECIFICATIONS AF Management
Model PM3210
Telemetry RF AF Suppression™ Algorithm Off; On
Dimensions (mm) 58 x 52 x 6 Lower Rate Overdrive (bpm) 4 10
Weight (g) 25 Upper Rate Overdrive (bpm) 4 5
Volume (cc) 13.71 No. of Overdrive Pacing Cycles 15-40 in steps of 5
Connector IS-1 Rate Recovery (ms) 8; 12
Atrial Tachycardia Detection
PARAMETER SETTINGS Rate (bpm) 110-200 in steps of 10; 225-300 in steps of 25
Resynchronization Therapy Auto Mode Switch Off; DDD(R) to DDI(R); DDD(R) to DDT(R); DDD(R) to VVI(R);
DDD(R) to VVT(R); VDD(R) to VVI(R); VDD(R) to VVT(R)
QuickOpt ® Timing Cycle AMS Base Rate (bpm) 40-170 in steps of 5
Optimization Sensed/Paced AV Delay; Interventricular Paced Delay
RV and LV Pulse Width (ms) 0.05; 0.1-1.5 in steps of 0.1
Stored Electrograms
RV and LV Pulse Amplitude (V) 0.25-4.0 in steps of 0.25; 4.5-7.5 in steps of 0.5
RV Pulse Configuration Unipolar; Bipolar
Options
LV Pulse Configuration Unipolar; Bipolar; LV Tip-RV Ring; LV Ring-RV Ring
Priority Options Off; Low; High
Ventricular Sense Configuration BV Unipolar Tip; BV Bipolar; RV Unipolar Tip; RV Bipolar;
Channel 1; 2; 3
LV Unipolar Tip; LV Bipolar; RV Unipolar Ring; LV Tip-RV Tip
Triggers
Ventricular Pacing Chamber BV; RV only; LV only (temporary mode)
Advanced Hysteresis Off; Low; High
First Chamber Paced Simultaneous2; RV; LV
AMS Entry/AMS Exit/
Interventricular Pace Delay (ms) 10-80 in steps of 5
AMS Entry and Exit Off; Low; High
AT/AF Detection Off; Low; High
Output/Sensing Magnet Response Off; Low; High
High Atrial Rate Off; Low; High
Negative AV Rate (bpm) 125-300 in steps of 25
Hysteresis Search (ms) Off; -10 to -120 in steps of 10 No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Shortest AV/PV Delay (ms) 25-50 in steps of 5; 60-120 in steps of 10 High Ventricular Rate Off; Low; High
SenseAbility® Technology Off; On (Automatic Sensitivity Control adjustment for atrial and Rate (bpm) 125-300 in steps of 25
ventricular events) No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
A Max Sensitivity (mV) 0.2-1.0 in steps of 0.1 PMT Termination Off; Low; High
V Max Sensitivity (mV) 0.2-2.0 in steps of 0.1 Consecutive PVCs Off; Low; High
Threshold Start (Atrial and Ventricular Post-Sense) 50; 62.5; 75; 100% No. of Consecutive PVCs 2; 3; 4; 5
(Atrial Post-Pace) 0.2-3.0 in steps of 0.1 mV Noise Reversion Off; Low; High
(Ventricular Post-Pace) Auto; 0.2-3.0 in steps of 0.1 mV
Decay Delay (ms) (Atrial and Ventricular Post-Sense) 0; 30; 60; 95; 125; 160; 190; 220
Other
(Atrial Post-Pace) 0; 30; 60; 95; 125; 160; 190; 220
(Ventricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220
A and V Lead Monitoring Monitor; Auto Polarity Switch
Ventricular Sensitivity (fixed) (mV) 0.5-5.0 in steps of 0.5; 6-10 in steps of 1.0; 12.53
A and V Low Impedance Limit (Ω) 100-500 in steps of 25
Rate/Timing A and V High Impedance Limit (Ω) 750-2500 in steps of 250; 3000
Magnet Response Off; Battery Test
Mode A00(R); AAI(R); AAT(R); VOO(R); VVI(R); VVT(R); DOO(R); Ventricular Intrinsic
DVI(R); DDI(R); DDT(R); DDD(R); VDD(R); Pacing Off Preference, VIP ® (ms) Off; 50-150 in steps of 25; 160-200 in steps of 10
DDT Trigger4 R wave VIP Search Interval 30 sec; 1; 3; 5; 10; 30 min
DDT Timing4 DDI VIP Search Cycles 1; 2; 3
Base Rate (bpm) 30-130 in steps of 5; 140-170 in steps of 10 Post-Ventricular Atrial Blanking
Hysteresis Rate (bpm) Off; 30-150 in steps of 55 (PVAB) (ms) 60-200 in steps of 10; 225; 250
Search Interval (min) Off; 1; 5; 10; 15; 30 Ventricular Safety Standby Off; On
Cycle Count 1-16 PVC Response Off; Atrial Pace7
Intervention Rate (bpm) Off; Same Base Rate; 80-120 in steps of 10 (Intrinsic +0; PMT Options Off; Passive; Atrial Pace7
Intrinsic +10; Intrinsic +20; Intrinsic +30) PMT Detection Rate (bpm) 90-180 in steps of 5
Intervention Duration (bpm) 1-10 Lead Type Uncoded; Unipolar; Bipolar
Recovery Time Fast; Medium; Slow; Very Slow NIPS Options
Rest Rate (bpm) Off; 30-150 in steps of 5 Stimulation Chamber Atrial; Right Ventricular
Maximum Tracking Rate (bpm) 90-130 in steps of 5; 140-180 in steps of 10 Coupling Interval8 (ms) 100-800 in steps of 10
Sensed AV Delay (ms) 25; 30-200 in steps of 10; 225-325 in steps of 25 S1 Count 2-25 in steps of 1
Paced AV Delay (ms) 25; 30-200 in steps of 10; 225-300 in steps of 25; 350 S19; S2; S3 and S4 Cycle (ms) Off; 100-800 in steps of 10 (Fixed or Adaptive)
Ventricular Pace/Sense Right Venticular
Refractory 6 (Fixed) (ms) 125; 160-400 in steps of 30; 440; 4707 Support Rate (bpm) Off; 30-95 in steps of 5
Atrial Pace Refractory 190-400 in steps of 30; 440; 4707 Sinus Node Recovery Delay (s) 1; 2; 3; 4; 5
Atrial Sense Refractory 93; 125; 157; 190-400 in steps of 30; 440; 4707 Diagnostic Trends AT/AF Burden; Exercise & Activity; Lead Impedance;
PVARP (ms) 125-500 in steps of 25 P and R Wave; A and V threshold
Atrial Protection Interval (ms) 4 125
Patient Notifiers
Far-Field Protection Interval (ms) 4 16
Programmable Notifiers (On; Off) Device at ERI; Atrial Lead Impedance Out of Range;
Rate-Modulated Ventricular Lead Impedance Out of Range; LV Lead Impedance
Out of Range; AT/AF Burden; AT/AF Episode Duration;
Rate Responsive AV/PV Delay Off; Low; Medium; High High V Rate During AT/AF
Rate Responsive PVARP/VREF Off; Low; Medium; High Device Reset On
Shortest PVARP/VREF 125-475 in steps of 25 Entry into Backup VVI Mode On
Sensor On; Off; Passive Audible Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
Max Sensor Rate (bpm) 80-150 in steps of 5; 160-180 in steps of 10 Number of Audible Alerts
Threshold Auto (-0.5); Auto (+0.0); Auto (+0.5); Auto (+1.0); per Notification 2
Auto (+1.5); Auto (+2.0); 1-7 in steps of 0.5 Number of Notifications 1-16
Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 Time Between Notifications (hours) 10; 22
Reaction Time Very Fast; Fast; Medium; Slow
Recovery Time Fast; Medium; Slow; Very Slow 1 ± 0.5 cc
2 LV first with 10 ms interventricular delay.
3 Sensitivity is with respect to a 20 ms haversine test signal.
4 This parameter is not programmable.
5 The highest available setting for hysteresis rate is 5 min-1 below the programmed base rate.
6 In dual-chamber modes, the Maximum Ventricular Refractory Period is 325 ms.
7 Programming options dependent on pacing mode.
8 During atrial NIPS in dual-chamber modes, the shortest Coupling Interval will be limited by the programmed AV/PV Delay.
9 S1 Burst Cycle is applied at the preprogrammed S1 cycle length.

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Outside U.S. Customer Support: 46-8-474-4147

CPS Direct® SL
Slittable Outer Guide Catheter

Product Highlights
n Reliable coronary sinus access
– E xcellent torque transmission and soft, atraumatic tip due to braid-reinforced,
multi-durometer PEBAX®* design.
– Unique SiteMark™ 3D markers provide fluoroscopic visibility to determine
anterior/posterior location and verify torque transfer.
– Seven curve options to satisfy needs of various anatomies and different
implanter techniques.
– Compatible with CPS Aim® cannulators and CPS Luminary® bideflectable
catheter with lumen to modify shape and extend reach if necessary. Indications: The St. Jude Medical CPS Direct ® SL slittable outer
guide catheter is designed for intracardiac access of the venous
system of the heart and to serve as a conduit during implantation
n Enables direct delivery to the target vein. for the delivery of contrast medium and St. Jude Medical devices
(including implantable left heart leads and delivery tools), and
support of fluids where minimizing blood loss is essential. In
– Soft, atraumatic tip with multi-durometer PEBAX shaft is designed to addition, CPS Direct ® SL slittable outer guide catheters can work
with inner catheters as a system.
provide flexibility to allow advancement of the catheter deep into the coronary
Adverse Events: As with any catheterization procedure, potential
venous system. complications include thromboembolism, local and systemic
infection, bleeding or hematoma at the puncture site, vascular
dissection or perforation, cardiac perforation, and cardiac
– CPS Direct® SL catheter can be tracked over CPS Aim® subselectors into the tamponade.
target vein. Upon removal of CPS Aim® subselector, the left-heart lead can be Please review the Instructions for Use prior to using these devices
for a complete listing of indications, contraindications, warnings,
delivered directly through the CPS Direct® SL catheter into the target vein. precautions, potential adverse events and directions for use.

Ordering Information
Contents: Outer guide catheter

Model Length (cm) Length (cm) Diameter (F) Diameter (F)

Number Curve Working Overall Inner Outer
410110 Straight (OC-STR) 47 54 7 9
410111 Multipurpose (OC-MP) 47 54 7 9
410112 115º (OC-115) 47 54 7 9
410113 135º (OC-135) 47 54 7 9
410114 Wide (OC-W) 47 54 7 9
410115 Extra wide (OC-XW) 47 54 7 9
410116 Right sided (OC-R) 47 54 7 9
410120 Straight (OC-STR) 54 61 7 9
410121 Multipurpose (OC-MP) 54 61 7 9
410122 115º (OC-115) 54 61 7 9
410123 135º (OC-135) 54 61 7 9
410124 Wide (OC-W) 54 61 7 9
410125 Extra wide (OC-XW) 54 61 7 9
410126 Right sided (OC-R) 54 61 7 9

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CPS Direct® SL
Slittable Outer Guide Catheter

Product Specifications
PHYSICAL SPECIFICATIONS
Model 47 cm 54 cm
Straight (OC-STR) 410110 410120
Multipurpose (OC-MP) 410111 410121
115° (OC-115) 410112 410122
135° (OC-135) 410113 410123
Wide (OC-W) 410114 410124
Extra Wide (OC-XW) 410115 410125
Right Sided (OC-R) 410116 410126
Working Length 47 cm 54 cm
Overall Length 54 cm 61 cm

Material Multi-durometer braid reinforced PEBAX®*

Inner Diameter 7F
Outer Diameter 9 F
Markers SiteMark™ 3D tungsten tip marker with
three gold marker bands set 5 mm apart

Dilator
Extension Past Catheter Tip 2.5 cm
Material Proprietary polyethylene blend tipped;
compatible with 0.035” guidewire

Accessories
Included

Hemostasis Valve Adapter Seals around .014” guidewire; accommodates up to 7 F

CPS® Valve Bypass Tool SL 7 F peelable tool, 5 cm useable length, (2 per package)
CPS® Slitter Compatible with St. Jude Medical® QuickSite ® leads

Available Separately Model

CPS Implant Kit

®
0.035” guidewire assembly, 12 cc syringe, 410190
18 Ga needle and needle guard assembly
CPS Slitter Compatible with St. Jude Medical’s 410191
QuickSite leads
CPS Valve Bypass Tool SL 7 F peelable sheath, 5 cm useable length 410192
(2 per package)

* PEBAX is a registered trademark of Arkema.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CPS Direct® SL II
Slittable Outer Guide Catheter

Product Highlights
n Reliable coronary sinus access
– E xcellent torque transmission and soft, atraumatic tip due to braid-reinforced, multi-durometer PEBAX® design.
– Unique SiteMark™ 3D markers provide fluoroscopic visibility to determine anterior/posterior location and verify torque transfer.
– Six curve options to satisfy needs of various anatomies and different implanter techniques.
– Compatible with CPS Aim® cannulators and CPS Luminary® bideflectable catheter with lumen to modify shape and extend
reach if necessary.
n Enables Direct-To-Target™ delivery to the target vein:
– Soft, atraumatic tip with multi-durometer PEBAX shaft is designed to provide flexibility to allow advancement of the
catheter deep into the coronary venous system.
– Compatible with CPS Aim® SL inner catheters, designed to assist with branch vein subselection and left ventricular lead delivery.
n Designed to reduce procedural steps during implant:
– Slittable hub and integrated shaft provide smooth transition during slitting of catheter.
– New U-channel valve bypass tool simplifies lead delivery.
– New ergonomic slitter facilitates smooth slitting.
n Designed for worry-free removal - catheter design features Smooth-Slit™ braiding technology and ergonomic slitter, designed
to allow effortless, best-in-class cutting, minimizing the risk of lead dislodgement upon catheter removal.

PEBAX is a registered trademark of Arkema.

Ordering Information
Contents: Outer guide catheter

Model Length (cm) Length (cm) Diameter (F) Diameter (F)

Number Curve Working Overall Inner Outer
DS2C001 Straight 47 50.7 7 9
DS2C002 115º 47 50.7 7 9
DS2C003 135º 47 50.7 7 9
DS2C004 Wide 47 50.7 7 9
DS2C005 X-Wide 47 50.7 7 9
DS2C006 Right Side 47 50.7 7 9
DS2C011 Straight 54 57.7 7 9
DS2C012 115º 54 57.7 7 9
DS2C013 135º 54 57.7 7 9
DS2C014 Wide 54 57.7 7 9
DS2C015 X-Wide 54 57.7 7 9

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CPS Direct® SL II
Slittable Outer Guide Catheter

Product Specifications
PHYSICAL SPECIFICATIONS

Slittable Outer Guide Catheter

Models CURVE SHAPE AVAILABLE LENGTH OVERALL LENGTH INNER DIAMETER OUTER DIAMETER
DS2C001 Straight 47 cm 50.7 cm 7F (2.44mm) 9F (3.00mm)
DS2C002 115º 47 cm 50.7 cm 7F (2.44mm) 9F (3.00mm)
DS2C003 135º 47 cm 50.7 cm 7F (2.44mm) 9F (3.00mm)
DS2C004 Wide 47 cm 50.7 cm 7F (2.44mm) 9F (3.00mm)
DS2C005 X-Wide 47 cm 50.7 cm 7F (2.44mm) 9F (3.00mm)
DS2C006 Right Side 47 cm 50.7 cm 7F (2.44mm) 9F (3.00mm)
DS2C011 Straight 54 cm 57.7 cm 7F (2.44mm) 9F (3.00mm)
DS2C012 115º 54 cm 57.7 cm 7F (2.44mm) 9F (3.00mm)
DS2C013 135º 54 cm 57.7 cm 7F (2.44mm) 9F (3.00mm)
DS2C014 Wide 54 cm 57.7 cm 7F (2.44mm) 9F (3.00mm)
DS2C015 X-Wide 54 cm 57.7 cm 7F (2.44mm) 9F (3.00mm)

Material Multi-durometer PEBAX® material reinforced with stainless steel braid wire for a kink-resistant catheter shaft
and distal soft tip. Lubricious coating on inner and outer surface.

Marker Three gold marker bands and two tungsten stripes on distal tip.

Accessories

Included Separately Available

Dilator CPS® Universal Slitter
2 Valve bypass tools CPS Direct ® Valve Bypass Tool
Implant Kit

Indications: The St. Jude Medical CPS Direct ® SL II slittable outer guide catheter is designed for Adverse Events: As with any catheterization procedure, potential complications include
intracardiac access of the venous system of the heart and to serve as a conduit during implantation for thromboembolism, local and systemic infection, bleeding or hematoma at the puncture site, vascular
the delivery of contrast medium and St. Jude Medical devices (including implantable left heart leads and dissection or perforation, cardiac perforation, and cardiac tamponade.
delivery tools), and support of fluids where minimizing blood loss is essential. In addition, CPS Direct ® SL
II slittable outer guide catheters can work with inner catheters as a system. Please review the Instructions for Use prior to using these devices for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CPS® Universal Slitter

Universal Slitter

Product Highlights
n Ergonomic design includes a rubber thumb grip for better stability while
slitting St. Jude Medical® catheters.
n Compatible with all St. Jude Medical leads (4 F to 6 F) and all slittable (SL)
catheters (CPS Aim® SL, CPS Direct® SL and CPS Direct® SL II).
n Designed to provide control throughout catheter removal process.

Ordering Information
Contents:Slitter

Model Number Lead Compatibility Catheter Compatibility

DS2A003 4 F to 6 F All St. Jude Medical slittable
catheters

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QuickFlex®
Left-Heart Lead

Product Highlights
n Superb deliverability combined with exceptional stability and performance.
n Steerable tip - distal tip angle can be controlled to maneuver through venous
anatomy.
n Flexible lead body
– E xpanded tip-to-ring electrode spacing of 20 mm.
– Shorter tip and ring electrodes reduce the length of rigid portions of the lead body.
n Low profile - 5.6 F proximal lead body, 5.0 F distal lead body, 4.0 F lead tip.
n Compatible with over-the-wire or stylet approaches.
n Composite construction - proximal polyurethane section and cable/coil conductors
are designed to offer exceptional push and torque, while the flexible distal silicone
portion is designed for improved tracking in tortuous anatomy.

Ordering Information
Contents: Left-heart lead

Model Insulation Insulation S-Curve Minimum

Number Proximal Distal Height (mm) Introducer (F) Connector Lengths (cm)
1156T Polyurethane Silicone 8 7 IS-1 bipolar 75, 86
1158T Polyurethane Silicone 16 7 IS-1 bipolar 75, 86

Indications/Intended Use: The QuickFlex ® Model 1156T and QuickFlex ® XL Model 1158T leads are 6 Potential Adverse Events: Potential adverse events associated with the use of left ventricular leads
French, transvenous, steroid eluting, bipolar, IS-1 compatible, S-shaped curve, passive fixation leads include: Allergic reaction to contrast media, body rejection phenomena, cardiac/coronary sinus dissection,
intended for permanent sensing and pacing of the left ventricle when used with a compatible St. Jude cardiac/coronary sinus perforation, cardiac tamponade, coronary sinus or cardiac vein thrombosis, death,
Medical® biventricular system. endocarditis, excessive bleeding, hematoma/seroma, induced atrial or ventricular arrhythmias, infection,
lead dislodgment, local tissue reaction; formation of fibrotic tissue, loss of pacing and/or sensing due to
Contraindications: The use of QuickFlex® leads is contraindicated in patients who are expected to be dislodgment or mechanical malfunction of the pacing lead, myocardial irritability, myopotential sensing,
hypersensitive to a single dose of 1.0 milligram of dexamethasone sodium phosphate, are unable to pectoral/diaphragmatic/phrenic nerve stimulation, pericardial effusion, pericardial rub, pneumothorax/
undergo an emergency thoracotomy procedure, have coronary venous vasculature that is inadequate for hemothorax, prolonged exposure to fluoroscopic radiation,m pulmonary edema, renal failure from contrast
lead placement, as indicated by venogram. media used to visualize coronary veins, rise in threshold and exit block, thrombolytic or air embolism,
valve damage. Performance of a coronary sinus venogram is unique to lead placement in the cardiac
venous system, and carries risks. Potential complications reported with direct subclavian venipuncture
include hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic
duct injury, cannulation of other vessels, massive hemorrhage, and rarely, death.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

QuickFlex®
Left-Heart Lead

Product Specifications
PHYSICAL SPECIFICATIONS
Model 1156T 1158T
Connector IS-1 Bipolar IS-1 Bipolar
Lead Length 7 5 cm, 86 cm 75 cm, 86 cm
Maximum Lead Body Size 6.0 F (2 mm/0.079”) 6.0 F (2 mm/0.079”)
Proximal Polyurethane Lead Body Size 5.6 F (1.85 mm/0.073”) 5.6 F (1.85 mm/0.073”)
Distal Silicone Rubber Lead Body Size 5.0 F (1.68 mm/0.066”) 5.0 F (1.68 mm/0.066”)
Tip Electrode Size 4.0 F (1.33 mm/0.052”) 4.0 F (1.33 mm/0.052”)
LV Lead Delivery System Introducer Size Minimum 7 F ID Minimum 7 F ID
Minimum S-Curve Height 8 mm 16 mm
Tip Electrode Pt/Ir, TiN coated, ring-shaped, Pt/Ir, TiN coated, ring-shaped,
two grooves two grooves
Steroid Dexamethasone sodium phosphate Dexamethasone sodium phosphate
Tip Electrode Surface Area 4.9 mm2 4.9 mm2
Ring Electrode Surface Area 7.4 mm2 7.4 mm2
Tip-to-Ring Electrode Spacing 20 mm 20 mm
Lead Body Insulation Proximal: polyurethane 55D Proximal: polyurethane 55D
Distal 7 cm: silicone rubber Distal 7 cm: silicone rubber
Lead Body Coating Fast-Pass® coating Fast-Pass® coating
Conductors
Distal (coil) MP35N ® MP35N ®
Proximal (cables) MP35N ® MP35N ®
Suture Sleeve Attached Attached

MP35N is a registered trademark of SPS Technologies, LLC.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

QuickFlex® µ
Left-Heart Lead

Product Highlights
n Superb deliverability combined with exceptional stability and performance.
n Low profile - 4.3 F lead body, 4.0 F lead tip.
n Steerable tip - distal tip angle can be controlled to maneuver through venous
anatomy.
n Flexible lead body
– Tip-to-ring electrode spacing of 20 mm.
– Shorter tip and ring electrodes reduce the length of rigid portions of the lead body.
n Allows Direct-To-Target™ placement through CPS Aim® SL inner catheter to deliver
leads to small, acute venous anatomies that may have been unreachable in the past.
n Optim® lead insulation – a chemical co-polymer that blends the best features of
polyurethane and silicone for improved handling and increased durability.
n Compatible with over-the-wire or stylet approaches.

Ordering Information
Contents: Left-heart lead

Model Insulation S-Curve Minimum

Number Height (mm) Introducer (F) Connector Lengths (cm)
1258T Optim 16 5 IS-1 bipolar 75, 86, 92

Indicationsand Usage: The QuickFlex ® lead has application as part of a St. Jude Medical® biventricular system.
Contraindications: The use of QuickFlex® leads is contraindicated in patients who:
n Are expected to be hypersensitive to a single dose of 1.0 mg of dexamethasone sodium phosphate.
n Are unable to undergo an emergency thoracotomy procedure.
n Have coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

QuickFlex® µ
Left-Heart Lead

Product Specifications
PHYSICAL SPECIFICATIONS
Model 1258T
Connector IS-1 Bipolar
Lead Length 75 cm, 86 cm, 92 cm
Lead Body Size 4.3 F (1.42 mm/0.056")
Tip Electrode Size 4.0 F (1.33 mm/0.052")
Ring Electrode Size 4.7 F (1.57 mm/0.062")
LV Lead Delivery System Introducer Size Minimum 5 F ID
Minimum S-Curve Height 16 mm
Tip Electrode Pt/Ir, TiN-coated, ring-shaped, two grooves
Steroid Dexamethasone sodium phosphate
Tip Electrode Surface Area 5.0 mm2
Ring Electrode Surface Area 7.4 mm2
Tip-to-Ring Electrode Spacing 20 mm
Lead Body Insulation Optim® insulation
Lead Body Coating Fast-Pass® coating
Conductors Distal (coil) MP35N ®
Proximal (cables) MP35N ®
Suture Sleeve Attached

Indications and Usage

The QuickFlex ® lead has application as part of a St. Jude Medical® biventricular system.

Contraindications

The use of QuickFlex leads is contraindicated in patients who:

Are expected to be hypersensitive to a single dose of 1.0 mg of dexamethasone sodium phosphate.

Are unable to undergo an emergency thoracotomy procedure.

Have coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

MP35N is a registered trademark of SPS Technologies, LLC.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

QuickSite®
Left-Heart Lead

Product Highlights
n Superb deliverability combined with exceptional stability and performance.
n Steerable tip – the distal tip can be controlled to maneuver through
venous anatomy.
n Low profile – 5.6 F proximal lead body, 5.0 F distal lead body.
n Compatible with over-the-wire or stylet approaches.
n Composite construction – proximal polyurethane section and cable/coil
conductors are designed to offer exceptional push and torque, while
the flexible distal silicone portion is designed for improved tracking in
tortuous anatomy.

Ordering Information
Contents: Left-heart lead

Model Insulation Insulation S-Curve Minimum

Number Proximal Distal Height (mm) Introducer (F) Connector Lengths (cm)
1058T Polyurethane Silicone 16 7 IS-1 bipolar 75, 86

Indications: The QuickSite ® leads have application as part of a St. Jude Medical® biventricular system. lead, myocardial irritability, myopotential sensing, pectoral/diaphragmatic/phrenic nerve stimulation,
pericardial effusion, pericardial rub, pneumothorax/hemothorax, prolonged exposure to fluoroscopic
Contraindications: The use of QuickSite leads is contraindicated in patients who are expected to be radiation, pulmonary edema, renal failure from contrast media used to visualize coronary veins, rise in
hypersensitive to a single dose of 1.0 milligram of dexamethasone sodium phosphate, are unable to threshold and exit block, thrombolytic or air embolism, valve damage.
undergo an emergency thoracotomy procedure or have coronary venous vasculature that is inadequate for
lead placement, as indicated by venogram. Performance of a coronary sinus venogram is unique to lead placement in the cardiac venous system, and
carries risks.
Potential Adverse Events: Possible adverse events associated with the QuickSite Lead System, include,
but are not limited to the following: allergic reaction to contrast media, body rejection phenomena, Potential complications reported with direct subclavian venipuncture include hemothorax, laceration of
cardiac/coronary sinus dissection, cardiac/coronary sinus perforation, cardiac tamponade, coronary sinus the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other
or cardiac vein thrombosis, death, device migration and pocket erosion, endocarditis, excessive bleeding, vessels, massive hemorrhage and, rarely, death.
hematoma/seroma, induced atrial or ventricular arrhythmias, infection, local tissue reaction; formation of
fibrotic tissue, loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the pacing Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse
event information.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

QuickSite®
Left-Heart Lead

Product Specifications
PHYSICAL SPECIFICATIONS
Model 1058T
Connector IS-1 Bipolar
Lead Length 75 cm, 86 cm
Maximum Lead Body Size 6.0 F (2 mm/0.079”) at PU – SR transition
Proximal Polyurethane Lead Body Size 5.6 F (1.85 mm/0.073”)
Distal Silicone Rubber Lead Body Size 5.0 F (1.68 mm/0.066”)
LV Lead Delivery System Introducer Size Minimum 7 F ID
Minimum S-Curve Height 16 mm
Tip Electrode Pt/Ir, TiN coated, two grooves, blunt tip
Steroid Dexamethasone sodium phosphate
Tip Electrode Surface Area 4.8 mm2
Ring Electrode Surface Area 14.7 mm2
Tip-to-Ring Electrode Spacing 20 mm
Lead Body Insulation Proximal: polyurethane 55D
Distal 7 cm: silicone rubber
Conductors Two ETFE-insulated low resistance cables,
multifilar MP35N ®* coil

ACCESSORIES

Suture Sleeves (2) White, radiopaque

Stylets (6) 0.36 mm/0.014” (diameter) PTFE-coated stainless steel
stylets, with 15 cm distal tapers:
Soft – 0.15 mm/0.006” (diameter) – green knob (3 stylets)
Firm – 0.20 mm/0.008” (diameter) – yellow knob (2 stylets)
Extra Firm – 0.25 mm/0.010” (diameter) – red knob (1 stylet)
Guidewire PTFE-coated, 180 cm long, 0.36 mm/0.014” (diameter)
with 5 cm floppy tip; two torque tools included
Lead Flushing Tools (2) White ABS coupling with Luer-Lok™** connector
Stylet Guide (funnel)
Vein Pick

* MP35N is a trademark of SPS Technologies, LLC.

** Luer-Lok is a trademark of Becton, Dickinson & Co.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page LHL11
Implantable Cardioverter
Defibrillator (ICD) Devices
Implantable Cardioverter Defibrillator (ICD) Devices

Current Accel® DR
Dual-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Highlights
n AutoCapture™ Pacing System offers the maximum in threshold adaptability and patient
safety with ventricular Beat-by-Beat™ capture confirmation. The AutoCapture Pacing
System automatically delivers a 5.0 V backup safety pulse when noncapture is detected.
n Vibratory Patient Notifier enables patients with hearing problems to be alerted to a low
battery, lead-related complications and more.
n ACap® Confirm Pacing System periodically completes a threshold search and
automatically adjusts amplitude to address patients’ changing atrial thresholds.
n DeFT Response® technology tools provide more clinically proven, noninvasive options
for managing high DFTs.
– Programmable pulse widths allow the user to tailor the shock to the individual patient.
– SVC shocking electrode can be quickly and noninvasively activated or deactivated
with the touch of a button.
– 36 J delivered energy provides substantial energy for defibrillation.
– Four programmable tilt options are available to accommodate variances among
patients.
n AT/AF Alerts notify patients and their clinics when a programmed AT/AF threshold
or continuous episode duration has been exceeded, or when a high ventricular rate
accompanies the AT/AF episode.
n The optional DF4 connector is designed to simplify implants by streamlining defibrillation
connections into a single terminal pin and reducing the number
of set screws.
n Ventricular Intrinsic Preference (VIP®) algorithm automatically searches for intrinsic
conduction.
n InvisiLink® wireless telemetry, in conjunction with the Merlin@home® transmitter and
Merlin.net® Patient Care Network (PCN), allows for daily remote monitoring and follow-up.

Ordering Information
Contents: Cardiac pulse generator

Model Dimensions Connector Connector

Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillation Sense/Pace
CD2215-36 77 x 50 x 14 80 42 DF-1 IS-1
CD2215-36Q 74 x 50 x 14 80 41 DF4 IS-1, DF4

Indications and Usage: The Current Accel pulse generators are intended to provide ventricular heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest
antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection,
ventricular arrhythmias. AF Suppression pacing is indicated for suppression of paroxysmal or persistent keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage,
atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. pneumothorax, shunting current or insulating myocardium during defibrillation with internal, or external
paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion,
Contraindications: Contraindications for use of the pulse generator system include ventricular venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical
tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte management, may develop psychological intolerance to an ICD or CRT-D system that may include the
imbalance, or acute myocardial infarction. following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious,
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system, fear of losing shock capability, imagined shocking (phantom shock).
include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and
allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of potential adverse events.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page ICD1
Implantable Cardioverter Defibrillator (ICD) Devices

Current Accel® DR
Dual-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Specifications
PHYSICAL SPECIFICATIONS Post-Therapy Pacing (independently programmable from Bradycardia and ATP )
Models CD2215-36 CD2215-36Q Post-Shock Pacing Mode Off; AAI; VVI; DDI; DDD
Telemetry RF RF Post-Shock Base Rate (ppm) 30-100 in increments of 5
Delivered/Stored Energy (J) 36/42 36/42 Post-Shock Pacing Duration (min) Off; 0.5; 1; 2.5; 5; 7.5; 10
Volume (cc) 42 41
Device Testing/Induction Methods
Weight (g) 80 80
Size (mm) 77 x 50 x 14 74 x 50 x 14 DC Fibber™ Pulse Duration (sec) 0.5-5.0
Defibrillation Lead Connections DF-1 DF4 Burst Fibber Cycle Length (ms) 20-100
Sense/Pace Lead Connections IS-1 IS-1, DF4 Noninvasive Programmed 2-25 stimuli with up to 3 extrastimuli
High-Voltage Can Electrically active titanium can Electrically active titanium can Stimulation (NIPS)
PARAMETERS Settings Patient Notifiers
AF Management Programmable Notifiers (On; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage;
Atrial Lead Impedance Out of Range; Ventricular Lead Impedance Out
AF Suppression™ Pacing On; Off
of Range; High-Voltage Lead Impedance Out of Range; AT/AF Burden;
No. of Overdrive Pacing Cycles 15-40 in steps of 5
V Rate During AT/AF; Backup VVI; Long AT/AF Episode
Maximum AF Suppression Rate (ppm) 80-150
Device Parameter Reset On
Sensing/Detection Entry into Backup VVI Mode On
SenseAbility® Technology Automatic Sensitivity Control adjustment for ventricular events Vibration Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
Threshold Start (Post-Sensed; Atrial) 50; 62.5; 75; 100%; Number of Vibrations per Notification 2
(Post-Paced; Atrial) 0.2-3.0 mV; Number of Notifications 1-16
(Post-Sensed; Ventricular) 50; 62.5; 75; 100%; Time Between Notifications (hours) 10; 22
(Post-Paced; Ventricular) Auto; 0.2-3.0 mV Electrograms and Diagnostic
Decay Delay (Post-Sensed/Post-Paced; Atrial/Ventricular) 0-220;
Stored Electrograms Up to 45 minutes including up to 1 minute programmable pre-trigger
(Post-Paced; Ventricular) Auto
data per VT/VF diagnosis/detection electrograms; triggers include:
Ventricular Sense Refractory (ms) 125; 157
detection or diagnosis and therapy; atrial episode; PMT termination;
Detection Zones VT-1; VT-2; VF
PC shock delivery; noise reversion; magnet reversion; and morphology
SVT Discriminators AV Rate Branch; Sudden Onset; Interval Stability; Morphology
template verification
Discrimination (MD) with Manual or Automatic Template Update
Therapy Summary Diagram of therapies delivered
Reconfirmation Continuous sensing during charging
Episodes Summary Directory listing of up to 60 episodes with access to more details including
Antitachycardia Pacing Therapy stored electrograms
ATP Configurations Ramp; Burst; Scan; 1 or 2 schemes per VT zone Lifetime Diagnostics History of bradycardia events and device-initiated charging
Burst Cycle Length Adaptive; Readaptive or Fixed AT/AF Burden Trend Trend data and counts
Min. Burst Cycle Length (ms) 150-400 in increments of 5 Ventricular HV Lead Impedance Trend Multi-Vector Trend Data
Number of Bursts 1-15 Sense and Capture Diagnostics Atrial and Ventricular Signal Amplitude trends and electrogram from last
Number of Stimuli 2-20 measurement, Atrial and RV Capture Threshold trends and electrogram
Add Stimuli per Burst On; Off from last measurement
ATP Pulse Amplitude (V) 7.5 independently programmable from Bradycardia and Post-Therapy Pacing Histograms Event Histogram; AV Interval Histogram; Mode Switch Duration Histogram;
ATP Pulse Width (ms) 1.0 or 1.5 independently programmable from Bradycardia Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Ventricular
and Post-Therapy Pacing Heart Rate Histogram; AT/AF Burden; Exercise and Activity Trending;
V Rates during AMS
High-Voltage Therapy PMT Data Information regarding PMT detections
High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt Real-Time Measurements (RTM) Pacing lead impedances; high-voltage lead impedances; unloaded battery
Waveform Biphasic; Monophasic voltage; and signal amplitudes
RV Polarity Cathode (-); Anode (+)
Electrode Configuration RV to Can; RV to SVC/Can
Bradycardia Pacing

Permanent Modes DDD(R); DDI(R); DOO(R); VVI(R); VOO(R); AAI(R); AOO(R)

Temporary Modes Off; DDD(R); DDI(R); VVI(R); AAI(R); AAT(R); DOO(R); VOO(R); AOO(R)
Rate-Adaptive Sensor On; Off; Passive
Programmable Rate and Off; Base Rate (ppm); Rest Rate (ppm); Maximum Tracking Rate (ppm);
Delay Parameters Maximum Sensor Rate (ppm); Paced AV Delay (ms); Sensed AV Delay (ms);
Rate Responsive AV Delay; Hysteresis Rate (ppm); Rate Hysteresis with Search
QuickOpt Timing Cycle Optimization Sensed/Paced AV delay
®

Auto Mode Switch (AMS) DDI(R); VVI(R)

Atrial Tachycardia Detection Rate (ppm) 110-300
AMS Base Rate (ppm) 40; 45; ... 135
Auto PMT Detection/Termination Atrial Pace; Off; Passive
Rate Responsive PVARP/VREF Off; Low; Medium; High
Ventricular Intrinsic Preference (VIP®) Off; 50-200 (50-150 in increments of 25; 160-200 in increments of 10)
Ventricular AutoCapture™ Pacing System On; Off
ACap® Confirm On; Monitor; Off

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page ICD2
Implantable Cardioverter Defibrillator (ICD) Devices

Fortify™ DR
Dual-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Highlights
n Unique 40 J delivered energy Safety Shock option can provide a greater DFT
safety margin.
n Vibratory Patient Notifier enables patients with hearing problems to be alerted
to a low battery, lead-related complications and more.
n QHR® chemistry battery provides greater capacity for enhanced longevity and
stable charge times.
n The addition of antitachycardia pacing (ATP) while charging and prior
to charging in the VF zone further extends the programming options for
terminating tachyarrhythmias without a high voltage shock.
n The Low Frequency Attenuation filter is designed to enhance sensing
performance and may reduce the possibility of oversensing T waves.
n The optional DF4 connector is designed to simplify implants by streamlining
defibrillation connections into a single terminal pin and reducing the number
of set screws.
n TailoredTherapy™ features designed to customize treatment to each patient’s
unique needs, including QuickOpt® Timing Cycle Optimization, which provides
quick and effective optimization for more patients at the push of a button, and
DeFT Response® Technology which provides more noninvasive programming
flexibility in the management of DFTs.
n Ventricular Intrinsic Preference (VIP®) algorithm automatically searches for
intrinsic conduction.

QHR is a registered trademark of Greatbatch Medical.

Ordering Information
Contents: Cardiac pulse generator

Model Dimensions Connector Connector

Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillation Sense/Pace
CD2231-40 74 x 40 x 14 76 35 DF1 IS-1
CD2231-40Q 71 x 40 x 14 75 35 DF4 DF4, IS-1

Indications for Use: Fortify pulse generators are intended to provide ventricular antitachycardia pacing Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system,
and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism,
Suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of
with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, Fortify pulse heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest
generators are also intended to provide a reduction of the symptoms of moderate to severe heart failure wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection,
(NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage,
medical therapy (as defined in the clinical trials section included in the Merlin® Patient Care System [PCS] pneumothorax, shunting current or insulating myocardium during defibrillation with internal, or external
on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion,
QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical
nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure. management, may develop psychological intolerance to an ICD or CRT-D system that may include the
following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious,
Contraindications: Contraindications for use of the pulse generator system include ventricular fear of losing shock capability, imagined shocking (phantom shock).
tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte
imbalance, or acute myocardial infarction. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
adverse events.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page ICD3
Implantable Cardioverter Defibrillator (ICD) Devices

Fortify™ DR
Dual-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Specifications
PHYSICAL SPECIFICATIONS Post-Therapy Pacing (independently programmable from Bradycardia and ATP )
Models CD2231-40 CD2231-40Q Post-Shock Pacing Mode Off; AAI; VVI; DDI; DDD
Telemetry RF RF Post-Shock Base Rate (ppm) 30-100 in increments of 5
Delivered/Stored Energy (J) 40/45 40/45 Post-Shock Pacing Duration (min) Off; 0.5; 1; 2.5; 5; 7.5; or 10
Volume (cc) 35 35
Device Testing/Induction Methods
Weight (g) 76 75
Size (mm) 74 x 40 x 14 71 x 40 x 14 DC Fibber™ Pulse Duration (sec) 0.5-5.0
Defibrillation Lead Connections DF-1 DF4 Burst Fibber Cycle Length (ms) 20-100
Sense/Pace Lead Connections IS-1 DF4, IS-1 Noninvasive Programmed 2-25 stimuli with up to 3 extrastimuli
High-Voltage Can Electrically active titanium can Electrically active titanium can Stimulation (NIPS)
PARAMETERS Settings Patient Notifiers
AF Management Programmable Notifiers (On; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage;
Atrial Lead Impedance Out of Range; Ventricular Lead Impedance Out
AF Suppression™ Pacing On; Off
of Range; High-Voltage Lead Impedance Out of Range; AT/AF Burden;
No. of Overdrive Pacing Cycles 15-40 in steps of 5
V Rate During AT/AF; Long AT/AF Episode
Maximum AF Suppression Rate 80-150 ppm
Device Parameter Reset On
Sensing/Detection Entry into Backup VVI Mode On
SenseAbility® Technology Automatic Sensitivity Control adjustment for atrial and ventricular events Vibration Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
Low Frequency Attenuation On; Off Number of Vibrations per Notification 2
Threshold Start (Post-Sensed; Atrial) 50; 62.5; 75; 100%; Number of Notifications 1-16
(Post-Paced; Atrial) 0.2-3.0 mV; Time Between Notifications (hours) 10; 22
(Post-Sensed; Ventricular) 50; 62.5; 75; 100%; Electrograms and Diagnostic
(Post-Paced; Ventricular) Auto; 0.2-3.0 mV
Stored Electrograms Up to 45 minutes including up to 1 minute programmable pre-trigger
Decay Delay (Post-Sensed/Post-Paced; Atrial/Ventricular) 0-220
data per VT/VF diagnosis/detection electrograms; triggers include
Ventricular Sense Refractory (ms) 125; 157
diagnosis; therapy; atrial episode; PMT termination; PC shock delivery;
Detection Zones VT-1; VT-2; VF
noise reversion; magnet reversion; and morphology template verification
SVT Discriminators AV Rate Branch; Sudden Onset; Interval Stability; Morphology
Therapy Summary Diagram of therapies delivered
Discrimination (MD) with Manual or Automatic Template Update
Episodes Summary Directory listing of up to 60 episodes with access to more details including
Reconfirmation Continuous sensing during charging
stored electrograms
Antitachycardia Pacing Therapy Lifetime Diagnostics History of bradycardia events and device-initiated charging
ATP Configurations Ramp; Burst; Scan; 1 or 2 schemes per VT zone AT/AF Burden Trend Trend data and counts
ATP in VF Zone ATP While Charging; ATP Prior to Charging; Off Ventricular HV Lead Impedance Trend Multi-Vector Trend Data
ATP Upper Rate Cutoff 150-300 bpm Histograms Event Histogram; AV Interval Histogram; Mode Switch Duration Histogram;
Burst Cycle Length Adaptive; Readaptive or Fixed Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Ventricular
Min. Burst Cycle Length (ms) 150-400 in increments of 5 Heart Rate Histogram; AT/AF Burden; Exercise and Activity Trending;
Number of Bursts 1-15 V Rates during AMS
Number of Stimuli 2-20 PMT Data Information regarding PMT detections
Add Stimuli per Burst On; Off Real-Time Measurements (RTM) Pacing lead impedances; high-voltage lead impedances;
ATP Pulse Amplitude (V) 7.5 independently programmable from Bradycardia and Post-Therapy Pacing and signal amplitudes
ATP Pulse Width (ms) 1.0 or 1.5 independently programmable from Bradycardia
and Post-Therapy Pacing
High-Voltage Therapy QHR is a registered trademark of Greatbatch Medical.

High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt

Waveform Biphasic; Monophasic
RV Polarity Cathode (-); Anode (+)
Electrode Configuration RV to Can; RV to SVC/Can
Bradycardia Pacing

Permanent Modes DDD(R); DDI(R); VVI(R); AAI(R); Pacer Off

Temporary Modes Off; DDD; DDI; VVI; AAI; AAT; DOO; VOO; AOO
Rate-Adaptive Sensor On; Off; Passive
Programmable Rate and Off; Base Rate (ppm); Rest Rate (ppm); Maximum Tracking Rate (ppm);
Delay Parameters Maximum Sensor Rate (ppm); Paced AV Delay (ms); Sensed AV Delay (ms);
Rate Responsive AV Delay; Hysteresis Rate (ppm); Rate Hysteresis with Search
QuickOpt ® Timing Cycle Optimization Sensed/Paced AV delay
Auto Mode Switch (AMS) Off; DDI(R); VVI(R)
Atrial Tachycardia Detection Rate 110-300
AMS Base Rate 40; 45; ... 135
Auto PMT Detection/Termination Atrial Pace; Off; Passive
Rate Responsive PVARP/VREF Off; Low; Medium; High
Ventricular Intrinsic Preference (VIP ®) Off; 50-200 (50-150 in increments of 25; 160-200 in increments of 10)
Ventricular AutoCapture ™
On; Off
Pacing System
ACap® Confirm On; Monitor; Off

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page ICD4
Implantable Cardioverter Defibrillator (ICD) Devices

Current Accel® VR
Single-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Highlights
n AutoCapture™ Pacing System offers the maximum in threshold adaptability
and patient safety with ventricular Beat-by-Beat™ capture confirmation. The
AutoCapture Pacing System automatically delivers a 5.0 V backup safety pulse
when noncapture is detected.
n Vibratory Patient Notifier enables patients with hearing problems to be alerted
to a low battery, lead-related complications and more.
n DeFT Response® technology tools provide more clinically proven, noninvasive
options for managing high DFTs.
– Programmable pulse widths allow the user to tailor the shock to the
individual patient.
– SVC shocking electrode can be quickly and noninvasively activated or
deactivated with the touch of a button.
– 36 J delivered energy provides substantial energy for defibrillation.
– Four programmable tilt options are available to accommodate variances
among patients.
n Unique SenseAbility ® feature, with Decay Delay and Threshold Start, provides
the flexibility to fine-tune sensing to individual patient needs.
n The optional DF4 connector is designed to simplify implants by streamlining
defibrillation connections into a single terminal pin and reducing the number
of set screws.
n InvisiLink® wireless telemetry, in conjunction with the Merlin@home®
transmitter and Merlin.net® Patient Care Network (PCN), allows for daily
remote monitoring and follow-up.

Ordering Information
Contents: Cardiac pulse generator

Model Dimensions Connector Connector

Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillation Sense/Pace
CD1215-36 76 x 50 x 14 79 41 DF-1 IS-1
CD1215-36Q 74 x 50 x 14 79 41 DF4 DF4

Indications and Usage: The Current Accel pulse generators are intended to provide ventricular wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection,
antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage,
ventricular arrhythmias. pneumothorax, shunting current or insulating myocardium during defibrillation with internal, or external
paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion,
Contraindications: Contraindications for use of the pulse generator system include ventricular venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical
tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte management, may develop psychological intolerance to an ICD or CRT-D system that may include the
imbalance, or acute myocardial infarction. following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious,
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system, fear of losing shock capability, imagined shocking (phantom shock).
include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and
allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of potential adverse events.
heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page ICD5
Implantable Cardioverter Defibrillator (ICD) Devices

Current Accel® VR
Single-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Specifications
PHYSICAL SPECIFICATIONS Device Testing/Induction Methods
Models CD1215-36 CD1215-36Q DC Fibber™ Pulse Duration (sec) 0.5-5.0
Telemetry RF RF Burst Fibber Cycle Length (ms) 20-100
Delivered/Stored Energy (J) 36/42 36/42 Noninvasive Programmed 2-25 stimuli with up to 3 extrastimuli
Volume (cc) 41 41 Stimulation (NIPS)
Weight (g) 79 79
Size (mm) 76 x 50 x 14 74 x 50 x 14 Patient Notifiers
Defibrillation Lead Connections DF-1 DF4
Programmable Notifiers (On; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage;
Sense/Pace Lead Connections IS-1 IS-1; DF4
Ventricular Lead Impedance Out of Range; High-Voltage Lead Impedance
High-Voltage Can Electrically active titanium can Electrically active titanium can
Out of Range; Backup VVI
Device Parameter Reset On
PARAMETERS Settings
Entry into Backup VVI Mode On
Sensing/Detection Vibration Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
SenseAbility® Technology Automatic Sensitivity Control adjustment for ventricular events Number of Vibrations per Notification 2
Threshold Start (Post-Sensed, Ventricular) 50; 62,5; 75; 100%; Number of Notifications 1-16
(Post-Paced, Ventricular) Auto; 0,2-3,0 mV Time Between Notifications (hours) 10; 22
Decay Delay (Post-Sensed/Post-Paced, Ventricular) 0-220;
Electrograms and Diagnostic
(Post-Paced Ventricular) Auto
Ventricular Sense Refractory (ms) 125; 157 Stored Electrograms Up to 45 minutes including up to 1 minute programmable pre-trigger
Detection Zones VT-1; VT-2; VF data per VT/VF diagnosis/detection electrograms; triggers include:
SVT Discriminators Sudden Onset; Interval Stability; Morphology Discrimination (MD) with detection or diagnosis and therapy; PC shock delivery; noise reversion;
Manual or Automatic Template Update magnet reversion; and morphology template verification
Reconfirmation Continuous sensing during charging Therapy Summary Diagram of therapies delivered
Episodes Summary Directory listing of up to 60 episodes with access to more details including
Antitachycardia Pacing Therapy stored electrograms
ATP Configurations Ramp; Burst; Scan; 1 or 2 schemes per VT zone Lifetime Diagnostics History of bradycardia events and device-initiated charging
Burst Cycle Length Adaptive; Readaptive or Fixed Ventricular HV Lead Impedance Trend Multi-Vector Trend Data
Min. Burst Cycle Length (ms) 150-400 in increments of 5 Sense and Capture Diagnostics Ventricular Signal Amplitude trends and measurement, RV Capture
Number of Bursts 1-15 Threshold trends and electrogram from last measurement
Number of Stimuli 2-20 Histograms Event Histogram; Ventricular Heart Rate Histogram; Exercise and
Add Stimuli per Burst On; Off Activity Trending
ATP Pulse Amplitude (V) 7.5 independently programmable from Bradycardia and Post-Therapy Pacing Real-Time Measurements (RTM) Pacing lead impedances; high-voltage lead impedances; unloaded battery
ATP Pulse Width (ms) 1.0 or 1.5 independently programmable from Bradycardia voltage; and signal amplitudes
and Post-Therapy Pacing

High-Voltage Therapy

High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt

Waveform Biphasic; Monophasic
RV Polarity Cathode (-); Anode (+)
Electrode Configuration RV to Can; RV to SVC/Can

Bradycardia Pacing

Permanent Modes Off; VVI(R); VOO(R)

Temporary Modes Off; VVI(R); VOO(R)
Rate-Adaptive Sensor On; Off; Passive
Programmable Rate Parameters Off; Base Rate (ppm); Rest Rate (ppm); Maximum Sensor Rate (ppm);
Hysteresis Rate (ppm); Rate Hysteresis with Search
Ventricular AutoCapture™ On; Off
Pacing System

Post-Therapy Pacing (independently programmable from Bradycardia and ATP )

Post-Shock Pacing Mode Off; VVI

Post-Shock Base Rate (ppm) 30-100 in increments of 5
Post-Shock Pacing Duration (min) Off; 0.5; 1; 2.5; 5; 7.5; 10

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page ICD6
Implantable Cardioverter Defibrillator (ICD) Devices

Current® Plus VR
Single-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Highlights
n The DF4 connector is designed to simplify implants by streamlining
defibrillation connections into a single terminal pin and reducing the number
of set screws.
n Vibratory Patient Notifier enables patients with hearing problems to be alerted
to a low battery, lead-related complications and more.
n Triple Redundancy Safety Platform is designed to minimize risk and increase
security and patient comfort through multiple hardware and software system
safeguards.
n Vibratory Patient Notifier enables patients with hearing problems to be alerted
to a low battery, lead-related complications and more.
n TailoredTherapy™ features designed to customize therapy to each patient’s
unique needs, including DeFT Response® Technology that allows more
noninvasive programming flexibility in the management of DFTs, and the
SenseAbility ® feature, which provides the flexibility to fine-tune sensing
to individual patient needs and help eliminate oversensing of T waves,
fractionated QRS complexes, and other extraneous signals.
n Automatic Daily High-Voltage Lead Integrity Test is designed to ensure
optimal patient safety.

Ordering Information
Contents: Cardiac pulse generator

Model Dimensions Connector Connector

Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillation Sense/Pace
CD1211-36Q 74 x 50 x 14 79 41 DF4 IS-1

Indications: The devices are intended to provide ventricular antitachycardia pacing and ventricular damage, pneumothorax, thromboemboli, venous occlusion. Other possible adverse effects include
defibrillation for automated treatment of life-threatening ventricular arrhythmias. 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
Contraindications: Contraindications for use of the pulse generator system include ventricular ventricular tachycardia, interruption of function due to electrical or magnetic interference, shunting of
tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte energy from defibrillation paddles, system failure due to ionising radiation. Other possible adverse effects
imbalance, or acute myocardial infarction. include mortality due to inappropriate delivery of therapy caused by: multiple counting of cardiac events
Adverse Events: Implantation of the pulse generator system, like that of any other device, involves risks, including T waves, P waves, or supplemental pacemaker stimuli. Among the psychological effects of
some possibly life-threatening. These include but are not limited to the following: acute hemorrhage/ device implantation are imagined pulsing, dependency, fear of inappropriate pulsing, and fear of losing
bleeding, air emboli, arrhythmia acceleration, cardiac or venous perforation, cardiogenic shock, cyst pulse capability.
formation, erosion, exacerbation of heart failure, extrusion, fibrotic tissue growth, fluid accumulation, Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
hematoma formation, histotoxic reactions, infection, keloid formation, myocardial irritability, nerve adverse events.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page ICD7
Implantable Cardioverter Defibrillator (ICD) Devices

Current® Plus VR
Single-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Specifications
PHYSICAL SPECIFICATIONS Device Testing/Induction Methods
Model CD1211-36Q
Telemetry RF DC Fibber™ Pulse Duration (sec) 0.5-5.0
Delivered Energy 36 J Burst Fibber Cycle Length (ms) 20-100
Volume (cc) 41 Noninvasive Programmed
Weight (g) 79 Stimulation (NIPS) 2-25 stimuli with up to three extrastimuli
Size (mm) 74 x 50 x 14
Defibrillation Lead Connections DF4 Patient Notifiers
Sense/Pace Lead Connections IS-1
High-Voltage Can Electrically active titanium can Programmable Notifiers (On, Off) Device at ERI, Charge Time Limit Reached, Possible HV Circuit
PARAMETER SETTINGS Damage, Ventricular Lead Impedance Out of Range, Backup VVI,
HV Lead Impedance Out of Range
Sensing/Detection
Device Parameter Reset On
Entry into Backup VVI Mode On
SenseAbility® Technology Automatic Sensitivity Control adjustment for ventricular events
Vibration Duration (sec) 2, 4, 6, 8, 10, 12, 14, 16
Threshold Start (Post-Sensed, Ventricular) 50; 62.5; 75; 100%; (Post-Paced,
Number of Vibrations per Notification 2
Ventricular) Auto, 0.2-3.0 mV
Number of Notifications 1-16
Decay Delay (Post-Sense/Post-Pace, Ventricular) 0-220; (Post-Pace Ventricular)
Time Between Notifications (hours) 10, 22
Auto
Ventricular Sense Refractory (ms) 125, 157
Detection Zones VT-1, VT-2, VF Electrograms and Diagnostics
SVT Discriminators Sudden Onset, Interval Stability, Morphology Discrimination (MD) with
Manual or Automatic Template Update Stored Electrograms Up to 45 minutes including up to one minute programmable
Reconfirmation Continuous sensing during charging pre-trigger data per VT/VF diagnosis/detection electrograms;
triggers include diagnosis, therapy, PC shock delivery, noise reversion,
magnet reversion, and morphology template verification
Antitachycardia Pacing Therapy Therapy Summary Diagram of therapies delivered
Episodes Summary Directory listing of up to 60 episodes with access to more details
ATP Configurations Ramp, Burst, Scan; 1 or 2 schemes per zone including stored electrograms
Burst Cycle Length Adaptive, Readaptive or Fixed Lifetime Diagnostics History of bradycardia events and device-initiated charging
Min. Burst Cycle Length (ms) 150-400 in increments of 5 Ventricular HV Lead Impedance Trend Multi-Vector Trend Data
Number of Bursts/Stimuli 1-15 with 2-20 Stimuli Histograms Event Histogram, Ventricular Heart Rate Histogram,
Add Stimuli per Burst On, Off Exercise and Activity Trending
Real-Time Measurements (RTM) Pacing lead impedances, high-voltage lead impedances, unloaded
High-Voltage Therapy battery voltage, and signal amplitudes

High-Voltage Output Mode Fixed Width, Fixed Tilt

Waveform Biphasic, Monophasic
RV Polarity Cathode (-), Anode (+)
Electrode Configuration RV to Can, RV to SVC/Can

Bradycardia Pacing

Permanent Modes Off, VVI(R), VOO(R)

Temporary Modes Off, VVI, VOO
Rate-Adaptive Sensor On, Off, Passive
Programmable Rate and Off, Base Rate (ppm), Rest Rate (ppm),
Delay Parameters Maximum Sensor Rate (ppm), Pulse Amplitude (Ventricular) (V),
Pulse Width (Ventricular) (ms), Hysteresis Rate (ppm)

Post-Therapy Pacing (Independently programmable from Bradycardia and ATP )

Post-Shock Pacing Mode Off, VVI

Post-Shock Base Rate (ppm) 30-100 in increments of 5
Post-Shock Pacing Duration (min) 0.5, 1, 2.5, 5, 7.5, or 10

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page ICD8
Implantable Cardioverter Defibrillator (ICD) Devices

Fortify™ VR
Single-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Highlights
n Unique 40 J delivered energy Safety Shock option can provide a greater DFT
safety margin.
n Vibratory Patient Notifier enables patients with hearing problems to be alerted
to a low battery, lead-related complications and more.
n QHR® chemistry battery provides greater capacity for enhanced longevity and
stable charge times.
n The addition of antitachycardia pacing (ATP) while charging and prior
to charging in the VF zone further extends the programming options for
terminating tachyarrhythmias.
n The Low Frequency Attenuation filter is designed to enhance sensing
performance and may reduce the possibility of oversensing T waves.
n The optional DF4 connector is designed to simplify implants by streamlining
defibrillation connections into a single terminal pin and reducing the number
of set screws.
n TailoredTherapy™ features designed to customize treatment to each patient’s
unique needs, including DeFT Response® Technology which provides more
noninvasive programming flexibility in the management of DFTs and unique
SenseAbility ® feature, with Decay Delay and Threshold Start, which provides
the flexibility to fine-tune sensing to individual patient needs.

QHR is a registered trademark of Greatbatch Medical.

Ordering Information
Contents: Cardiac pulse generator

Model Dimensions Connector Connector

Number (H x W x T, mm) Weight (g) Volume (cc) Defibrillation Sense/Pace
CD1231-40 73 x 40 x 14 76 35 DF1 IS-1
CD1231-40Q 71 x 40 x 14 75 35 DF4 DF4

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page ICD9
Implantable Cardioverter Defibrillator (ICD) Devices

Fortify™ VR
Single-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Specifications
PHYSICAL SPECIFICATIONS Post-Therapy Pacing (independently programmable from Bradycardia and ATP)
Models CD1231-40 CD1231-40Q Post-Shock Pacing Mode Off; VVI
Telemetry RF RF Post-Shock Base Rate (ppm) 30-100 in increments of 5
Delivered/Stored Energy (J) 40/45 40/45 Post-Shock Pacing Duration (min) Off; 0.5; 1; 2.5; 5; 7.5; or 10
Volume (cc) 35 35
Device Testing/Induction Methods
Weight (g) 76 75
Size (mm) 73 x 40 x 14 71 x 40 x 14 DC Fibber™ Pulse Duration (sec) 0.5-5.0
Defibrillation Lead Connections DF-1 DF4 Burst Fibber Cycle Length (ms) 20-100
Sense/Pace Lead Connections IS-1 DF4 Noninvasive Programmed 2-25 stimuli with up to 3 extrastimuli
High-Voltage Can Electrically active titanium can Electrically active titanium can Stimulation (NIPS)
PARAMETERS Settings Patient Notifiers
Sensing/Detection Programmable Notifiers (On; Off) Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage;
Ventricular Lead Impedance Out of Range; High-Voltage Lead Impedance
SenseAbility® Technology Automatic Sensitivity Control adjustment for atrial and ventricular events
Out of Range
Low Frequency Attenuation On; Off
Device Parameter Reset On
Threshold Start (Post-Sensed; Atrial) 50; 62.5; 75; 100%;
Entry into Backup VVI Mode On
(Post-Paced; Atrial) 0.2-3.0 mV;
Vibration Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
(Post-Sensed; Ventricular) 50; 62.5; 75; 100%;
Number of Vibrations per Notification 2
(Post-Paced; Ventricular) Auto; 0.2-3.0 mV
Number of Notifications 1-16
Decay Delay (Post-Sensed/Post-Paced; Atrial/Ventricular) 0-220
Time Between Notifications (hours) 10; 22
Ventricular Sense Refractory (ms) 125; 157
Detection Zones VT-1; VT-2; VF Electrograms and Diagnostic
SVT Discriminators AV Rate Branch; Sudden Onset; Interval Stability; Morphology
Stored Electrograms Up to 45 minutes including up to 1 minute programmable pre-trigger
Discrimination (MD) with Manual or Automatic Template Update
data per VT/VF diagnosis/detection electrograms; triggers include
Reconfirmation Continuous sensing during charging
diagnosis; therapy; PC shock delivery; noise reversion; magnet reversion;
Antitachycardia Pacing Therapy and morphology template verification
Therapy Summary Diagram of therapies delivered
ATP Configurations Ramp; Burst; Scan; 1 or 2 schemes per VT zone
Episodes Summary Directory listing of up to 60 episodes with access to more details including
ATP in VF Zone ATP While Charging; ATP Prior to Charging; Off
stored electrograms
ATP Upper Rate Cutoff 150-300 bpm
Lifetime Diagnostics History of bradycardia events and device-initiated charging
Burst Cycle Length Adaptive; Readaptive or Fixed
Ventricular HV Lead Impedance Trend Multi-Vector Trend Data
Min. Burst Cycle Length (ms) 150-400 in increments of 5
Histograms Event Histogram; Ventricular Heart Rate Histogram; Exercise and
Number of Bursts 1-15
Activity Trending
Number of Stimuli 2-20
Real-Time Measurements (RTM) Pacing lead impedances; high-voltage lead impedances;
Add Stimuli per Burst On; Off
and signal amplitudes
ATP Pulse Amplitude (V) 7.5 independently programmable from Bradycardia and Post-Therapy Pacing
ATP Pulse Width (ms) 1.0 or 1.5 independently programmable from Bradycardia
and Post-Therapy Pacing
QHR is a registered trademark of Greatbatch Medical.
High-Voltage Therapy

High-Voltage Output Mode Fixed Pulse Width; Fixed Tilt

Waveform Biphasic; Monophasic
RV Polarity Cathode (-); Anode (+)
Electrode Configuration RV to Can; RV to SVC/Can
Bradycardia Pacing

Permanent Modes VVI(R); Pacer Off

Temporary Modes Off; VVI; VOO
Rate-Adaptive Sensor On; Off; Passive
Programmable Off; Base Rate (ppm); Rest Rate (ppm); Maximum Sensor Rate (ppm);
Rate Parameters Pulse Hysteresis Rate (ppm); Rate Hysteresis with Search
Ventricular AutoCapture™ On; Off
Pacing System

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Durata®
Defibrillation Lead

Product Highlights
n The DF4 connector is designed to simplify implants by streamlining
defibrillation connections into a single terminal pin and reducing the number
of set screws.
n Redundant conductors serve as a backup system in the unlikely event of a
conductor failure.
n Symmetrically aligned cables within the lead body and centrally located coil
provide for additional protection to the inner coil.
n Optim® insulation – blends the biostability and flexibility of high-performance
silicone rubber with the strength, tear resistance and abrasion resistance of
polyurethane.
n Two innovative designs are intended to help prevent tissue ingrowth –
flat-wire technology provides a low profile for the defibrillation coils, and
silicone backfilling completely fills the shock coil space.

Ordering Information
Contents: Defibrillation lead

Model Min. Shock Tip-to-Proximal

Number Insulation Fixation Introducer (F) Configuration Sensing Coil (cm) Connector Lengths (cm)

7120Q Optim Ext/Ret Helix 7 Dual-coil True bipolar 17 DF4 52, 58, 65
7121Q Optim Ext/Ret Helix 7 Dual-coil True bipolar 21 DF4 52, 58, 65
7122Q Optim Ext/Ret Helix 7 Single-coil True bipolar N/A DF4 52, 58, 65
7170Q Optim Tines 7 Dual-coil True bipolar 17 DF4 52, 58, 65
7171Q Optim Tines 7 Dual-coil True bipolar 21 DF4 52, 58, 65

Indications for Use: The Durata™ Models 7120Q, 7121Q, 7122Q, 7170Q and 7171Q transvenous leads Potential Complications: Possible complications of the use of transvenous lead systems include, but are
are indicated for use with compatible pulse generators (refer to the applicable defibrillator manual for not limited to, supraventricular or ventricular arrhythmias, conduction disturbances, cardiac perforation,
system indications). They provide pacing and sensing and deliver cardioversion/defibrillation therapy cardiac tamponade, loss of contractility, air embolism, heart wall rupture, myocarditis, post-operative
to the heart. A transvenous lead system may offer the patient the benefit of avoiding a thoracotomy for heart failure, chronic mechanical stimulation of the heart, tricuspid valve dysfunction, lead fracture
lead implantation. If the initial lead configuration is not effective, repositioning of the lead or other lead necessitating surgical removal, pneumothorax, hemothorax, infection, tissue necrosis, and erosion of the
configurations should be attempted. In some patients, a nonthoracotomy lead configuration may not skin. Specific events and effects are summarized below:
provide reliable conversion of arrhythmias, and the use of subcutaneous or epicardial patch defibrillation
leads should be considered. WARNING: Implanted cardiac leads are subjected to a hostile environment within the body due to
constant, complex flexural and torsional forces, interactions with leads and/or the pulse generator, or
Contraindications: Contraindications for use of the Durata leads with an implantable pulse generator other forces associated with cardiac contractions and patient physical activity, posture, and anatomical
include ventricular tachyarrhythmias resulting from transient or reversible factors such as drug toxicity, influences. Cardiac leads’ functional lifetimes can be affected by these and other factors.
electrolyte imbalance, or acute myocardial infarction. Transvenous lead systems are contraindicated for
patients with tricuspid valvular disease or a mechanical heart valve. Durata leads are contraindicated for Refer to the defibrillator manual for additional complications and precautions specific to the pulse
patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is contraindicated. The generator.
Durata 7120Q, 7121Q, 7122Q, 7170Q and 7171Q leads are contraindicated for extra firm (red color knob)
stylets. The lead is not designed, sold, or intended for use other than as indicated.
1. St. Jude Medical DF-1 lead connectors conform to the international connector standard ISO 11318/Amd. 1.
2. St. Jude Medical IS-1 lead connectors conform to the international connector standard ISO 5841-3.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Durata®
Defibrillation Lead

Product Specifications
PHYSICAL SPECIFICATIONS

True Bipolar, Active-Fixation Defibrillation Leads

Models 7120Q 7121Q 7122Q
Fixation Ext/Ret Helix
Shock Configuration Dual-Coil Single-Coil
Sensing Configuration True Bipolar
Min. Size Introducer (F) 7
Lengths (cm) 52, 58, 65
Body Diameter (F) 6.8
Tip-to-Anode Spacing (mm) 11
Tip-to-Distal Coil (cm) 17
Tip-to-Proximal Coil (cm) 17 21 N/A
Tip Electrode Area (mm2) 6
Steroid Plug Yes
Distal Shock Coil Area (mm2) 367

True Bipolar, Passive-Fixation Defibrillation Leads

Models 7170Q 7171Q
Fixation Tines
Shock Configuration Dual-Coil
Sensing Configuration True Bipolar
Min. Size Introducer (F) 7
Lengths (cm) 52, 58, 65
Body Diameter (F) 6.8
Tip-to-Anode Spacing (mm) 11
Tip-to-Distal Coil (cm) 17
Tip-to-Proximal Coil (cm) 17 21
Tip Electrode Area (mm2) 3.5
Steroid Plug Yes
Distal Shock Coil Area (mm2) 367

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Accent® DR
Dual-Chamber Pacemaker

Product Highlights
n Inductive remote follow-up utilizing a wand, in conjunction with the Merlin@home®
transmitter and Merlin.net® Patient Care Network(PCN), allows patients to download
information and provide the clinic with access to device measurements.
n A two-tone audible alert allows programming to notify the patient of changes in
device performance or arrhythmia status, which can provide earlier insight into
actionable clinical events.
n Ventricular AutoCapture™ Pacing System offers the maximum in threshold
adaptability and patient safety with ventricular Beat-by-Beat™ capture confirmation.
The AutoCapture Pacing System automatically delivers a 5.0 V backup safety pulse
when noncapture is detected, and it may be programmed to either a bipolar or
unipolar configuration.
n AT/AF Alerts can be programmed to notify patients and/or their clinic when a
programmed AT/AF threshold or continuous episode duration has been exceeded, or
when a high ventricular rate accompanies the AT/AF episode.
n E xclusive AF Suppression™ algorithm is clinically proven to suppress episodes of
paroxysmal and persistent AF.
n Real-time electrogram (EGM) waveform, as well as the associated event markers that
precede and follow a specific triggering event, can be programmed to automatically
record up to 14 minutes of stored EGMs when encountering one or more
programmable trigger options.
n Ventricular Intrinsic Preference (VIP®) algorithm automatically searches for intrinsic
conduction.

Ordering Information
Contents: Cardiac pulse generator

Model Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector

PM2110 46 x 52 x 6 19 10.5 (± 0.5 cc) IS-1

Indications: Implantation is indicated in one or more of the following permanent conditions: syncope, contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction,
presyncope, fatigue, disorientation due to arrhythmia/bradycardia, or any combination of those symptoms. or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction.
would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing
is indicated for those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and third- Potential Adverse Events: The following are potential complications associated with the use of any
degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when pacing system: air embolism, body rejection phenomena, cardiac tamponade or perforation, hematoma,
tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus bleeding hematoma, seroma, formation of fibrotic tissue, local tissue reaction, inability to interrogate
node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated or program due to programmer or device malfunction, infection/erosion, interruption of desired pulse
for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A-V block generator function due to electrical interference, either electromyogenic or electromagnetic, lead
or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression Pacing is indicated malfunction due to conductor fracture or insulation degradation, loss of capture or sensing due to lead
for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the dislodgement or reaction at the electrode/tissue interface, loss of desired pacing and/or sensing due
above pacing indications. to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to
insulation), loss of normal device function due to battery failure or component malfunction, pacemaker
Contraindications: Implanted Cardioverter-Defibrillator (ICD). Devices are contraindicated in patients migration or pocket erosion, pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation,
with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients pneumothorax/hemothorax, device migration and pocket erosion, endocarditis, excessive bleeding,
who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An induced atrial or ventricular arrhythmias, myocardial irritability, pericardial effusion, pericardial rub,
appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation pulmonary edema, rise in threshold and exit block, valve damage.
rate tolerated by the patient. AF Suppression stimulation is not recommended in patients who cannot
tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that adverse events.
of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Accent® DR
Dual-Chamber Pacemaker

Product Specifications
PHYSICAL SPECIFICATIONS AF Management
Model PM2110
Telemetry Inductive AF Suppression™ Algorithm Off; On
Dimensions (mm) 46 x 52 x 6 Lower Rate Overdrive (bpm) 103
Weight (g) 19 Upper Rate Overdrive (bpm) 53
Volume (cc) 10.51 No. of Overdrive Pacing Cycles 15-40 in steps of 5
Connector IS-1 Rate Recovery (ms) 8; 123
Maximum AF
PARAMETER SETTINGS Suppression Rate (bpm) 80-150 in steps of 5; 160-180 in steps of 10
Rate/Timing Atrial Tachycardia
Detection Rate (bpm) 110-200 in steps of 10; 225-300 in steps of 25
Atrial Pace Refractory (ms) 190-400 in steps of 30; 440; 4702 Auto Mode Switch Off; DDD(R) to DDI(R); DDD(R) to VVI(R);
Atrial Sense Refractory (ms) 93; 125; 157; 190-400 in steps of 30; 440; 4702 VDD(R) to VVI(R)
Atrial Protection Interval (ms) 1253 AMS Base Rate (bpm) 40-170 in steps of 5
Paced AV Delay (ms) 25; 30-200 in steps of 10; 225-300 in steps of 25; 350 Stored Electrograms
Base Rate (bpm) 30-130 in steps of 5; 140-170 in steps of 10
Far-Field Protection Interval (ms) 163 Options
Hysteresis Rate (bpm) Off; 30-150 in steps of 5 4 Priority Options Off; Low; High
Search Interval (min) Off; 1; 5; 10; 15; 30 Channel 1; 2; 3
Cycle Count 1-16 in steps of 1 Triggers
Intervention Rate (bpm) Off; Same Base Rate; 80-120 in steps of 10 (Intrinsic +0; Advanced Hysteresis Off; Low; High
Intrinsic +10; Intrinsic +20; Intrinsic +30) AMS Entry/AMS Exit/
Intervention Duration (min) 1-10 in 1-minute intervals AMS Entry and Exit Off; Low; High
Recovery Time Fast; Medium; Slow; Very Slow AT/AF Detection Off; Low; High
Maximum Tracking Rate (bpm) 90-130 in steps of 5; 140-180 in steps of 10 Magnet Response Off; Low; High
Mode AOO(R); AAI(R); AAT(R); VOO(R); VVI(R); High Atrial Rate Off; Low; High
VVT(R); VDD(R); DOO(R); DVI(R); DDI(R); Rate (bpm) 125-300 in steps of 25
DDD(R); Pacing Off No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Post-Ventricular Atrial Blanking (ms) 60-200 in steps of 10; 225; 250 High Ventricular Rate Off; Low; High
PVARP (ms) 125-500 in steps of 25 Rate (bpm) 125-300 in steps of 25
Sensed AV Delay (ms) 25; 30-200 in steps of 10; 225-325 in steps of 25 No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Rest Rate (bpm) Off; 30-150 in steps of 5 PMT Termination Off; Low; High
Shortest AV Delay (ms) 25-50 in steps of 5; 60-120 in steps of 10 Consecutive PVCs Off; Low; High
Ventricular Blanking (ms) Auto; 12-52 in steps of 4 No. of Consecutive PVCs 2; 3; 4; 5
Ventricular Pace/Sense Refractory5 Noise Reversion Off; Low; High
(Fixed) (ms) 125; 160-400 in steps of 30; 440; 4702 Other
Output/Sensing
A and V Lead Monitoring Monitor; Auto Polarity Switch
Atrial Sensitivity (mV) 0.1-0.46 in steps of 0.1; 0.5; 0.75-2.0 in steps of 0.25; A and V Low Impedance Limit (Ω) 100-500 in steps of 25
2.5-4.0 in steps of 0.5; 5.07 A and V High Impedance Limit (Ω) 750-2500 in steps of 250; 3000
Ventricular AutoCapture™ Lead Type Uncoded; Unipolar; Bipolar
Pacing System On; Off Magnet Response Off; Battery Test
Primary Pulse Configuration Unipolar; Bipolar Negative AV Hysteresis Search (ms) Off; -10 to -120 in steps of 10
Backup Pulse Configuration Unipolar; Bipolar NIPS Options
Backup Pulse Amplitude (V) 5.03 Stimulation Chamber Atrial; Ventricular
Search Interval (hours) 8; 24 Coupling Interval (ms) 100-800 in steps of 108
AutoCapture S1 Count 2-25 in steps of 1
Paced/Sensed AV Delay (ms) 50/25; 100/70; 120/100 S19; S2; S3 and S4 Cycle (ms) Off; 100-800 in steps of 10 (Fixed or Adaptive)
Ventricular Sensitivity (mV) 0.5-5.0 in steps of 0.5; 6-10 in steps of 1.0; 12.57 Ventricular Support Rate (bpm) Off; 30-95 in steps of 5
SenseAbility® Technology Off; On (Automatic Sensitivity Control adjustment for atrial Sinus Node Recovery Delay (sec) 1; 2; 3; 4; 5
and ventricular events) PMT Options Off; Passive; Atrial Pace2
A Max Sensitivity (mV) 0.2-1.0 in steps of 0.1 PMT Detection Rate (bpm) 90-180 in steps of 5
V Max Sensitivity (mV) 0.2-2.0 in steps of 0.1 PVC Response Off; Atrial Pace2
Threshold Start (Atrial and Ventricular Post-Sense) 50; 62.5; 75; 100% Ventricular Intrinsic
(Atrial Post-Pace) 0.2-3.0 in steps of 0.1 mV Preference, VIP ® (ms) Off; 50-150 in steps of 25; 160-200 in steps of 10
(Ventricular Post-Pace) Auto; 0.2-3.0 in steps of 0.1 mV VIP Search Interval 30 sec; 1; 3; 5; 10; 30 min
Decay Delay (ms) (Atrial and Ventricular Post-Sense) 0; 30; 60; 95; 125; 160; 190; 220 VIP Search Cycles 1; 2; 3
(Atrial Post-Pace) 0; 30; 60; 95; 125; 160; 190; 220 Ventricular Safety Standby Off; On
(Ventricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Diagnostic Trends AT/AF Burden; Exercise & Activity; Lead Impedance;
Rate-Modulated Parameters P and R Wave; A and V Threshold
Patient Notifiers
Maximum Sensor Rate (bpm) 80-150 in steps of 5; 160-180 in steps of 10
Rate Responsive AV Delay Off; Low; Medium; High Programmable Notifiers (On; Off) Device at ERI; Atrial Lead Impedance Out of Range;
Rate Responsive PVARP/VREF Off; Low; Medium; High Ventricular Lead Impedance Out of Range; AT/AF Burden;
Reaction Time Very Fast; Fast; Medium; Slow AT/AF Episode Duration; High V Rate During AT/AF
Recovery Time Fast; Medium; Slow; Very Slow Device Reset On
Sensor On; Off; Passive Entry into Backup VVI Mode On
Shortest PVARP/VREF (ms) 125-475 in steps of 25 Audible Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Number of Audible Alerts
Auto (+3); 1-16 in steps of 1 per Notification 2
Threshold Auto (-0.5); Auto (+0.0); Auto (+0.5); Auto (+1.0); Number of Notifications 1-16
Auto (+1.5); Auto (+2.0); 1-7 in steps of 0.5 Time Between Notifications (hours) 10; 22

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Accent® DR RF
Dual-Chamber Pacemaker

Product Highlights
n InvisiLink® Wireless Telemetry, in conjunction with the Merlin@home®
transmitter and Merlin.net® Patient Care Network (PCN), allows for daily
remote monitoring and follow-up.
n AT/AF Alerts can be programmed to notify patients and/or their clinic when
a programmed AT/AF threshold or continuous episode duration has been
exceeded, or when a high ventricular rate accompanies the AT/AF episode.
n E xclusive AF Suppression™ algorithm is clinically proven to suppress episodes
of paroxysmal and persistent AF.
n Real-time electrogram (EGM) waveform, as well as the associated event
markers that precede and follow a specific triggering event, can be
programmed to automatically record up to 14 minutes of stored EGMs when
encountering one or more programmable trigger options.
n AutoCapture™ Pacing System offers the maximum in threshold adaptability
and patient safety with ventricular Beat-by-Beat™ capture confirmation.
n Ventricular Intrinsic Preference (VIP®) algorithm automatically searches for
intrinsic conduction.

Ordering Information
Contents: Cardiac pulse generator

Model Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector

PM2210 52 x 52 x 6 23 12.8 1
IS-1

Indications: Implantation is indicated in one or more of the following permanent conditions: syncope, contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction,
presyncope, fatigue, disorientation due to arrhythmia/bradycardia, or any combination of those symptoms. or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction.
would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing
is indicated for those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and Potential Adverse Events: The following are potential complications associated with the use of any
third-degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block pacing system: air embolism, body rejection phenomena, cardiac tamponade or perforation, hematoma,
when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with bleeding hematoma, seroma, formation of fibrotic tissue, local tissue reaction, inability to interrogate
sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is or program due to programmer or device malfunction, infection/erosion, interruption of desired pulse
indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of generator function due to electrical interference, either electromyogenic or electromagnetic, lead
A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression is indicated malfunction due to conductor fracture or insulation degradation, loss of capture or sensing due to lead
for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the dislodgement or reaction at the electrode/tissue interface, loss of desired pacing and/or sensing due
above pacing indications. to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to
insulation), loss of normal device function due to battery failure or component malfunction, pacemaker
Contraindications: Implanted Cardioverter-Defibrillator (ICD). Devices are contraindicated in patients migration or pocket erosion, pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation,
with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients pneumothorax/hemothorax, device migration and pocket erosion, endocarditis, excessive bleeding,
who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An induced atrial or ventricular arrhythmias, myocardial irritability, pericardial effusion, pericardial rub,
appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation pulmonary edema, rise in threshold and exit block, valve damage.
rate tolerated by the patient. AF Suppression stimulation is not recommended in patients who cannot
tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that adverse events.
of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Accent® DR RF
Dual-Chamber Pacemaker

Product Specifications
PHYSICAL SPECIFICATIONS AF Management
Model PM2210
Telemetry RF AF Suppression™ Algorithm Off; On
Dimensions (mm) 52 x 52 x 6 Lower Rate Overdrive (bpm) 103
Weight (g) 23 Upper Rate Overdrive (bpm) 53
Volume (cc) 12.81 No. of Overdrive Pacing Cycles 15-40 in steps of 5
Connector IS-1 Rate Recovery (ms) 8; 123
Maximum AF
PARAMETER SETTINGS Suppression Rate (bpm) 80-150 in steps of 5; 160-180 in steps of 10
Rate/Timing Atrial Tachycardia
Detection Rate (bpm) 110-200 in steps of 10; 225-300 in steps of 25
Atrial Pace Refractory (ms) 190-400 in steps of 30; 440; 4702 Auto Mode Switch Off; DDD(R) to DDI(R); DDD(R) to VVI(R);
Atrial Sense Refractory (ms) 93; 125; 157; 190-400 in steps of 30; 440; 4702 VDD(R) to VVI(R)
Atrial Protection Interval (ms) 1253 AMS Base Rate (bpm) 40-170 in steps of 5
Paced AV Delay (ms) 25; 30-200 in steps of 10; 225-300 in steps of 25; 350
Base Rate (bpm) 30-130 in steps of 5; 140-170 in steps of 10 Stored Electrograms
Far-Field Protection Interval (ms) 163
Hysteresis Rate (bpm) Off; 30-150 in steps of 5 4 Options
Search Interval (min) Off; 1; 5; 10; 15; 30 Priority Options Off; Low; High
Cycle Count 1-16 in steps of 1 Channel 1; 2; 3
Intervention Rate (bpm) Off; Same Base Rate; 80-120 in steps of 10 (Intrinsic +0; Triggers
Intrinsic +10; Intrinsic +20; Intrinsic +30) Advanced Hysteresis Off; Low; High
Intervention Duration (min) 1-10 in 1-minute intervals AMS Entry/AMS Exit/
Recovery Time Fast; Medium; Slow; Very Slow AMS Entry and Exit Off; Low; High
Maximum Tracking Rate (bpm) 90-130 in steps of 5; 140-180 in steps of 10 AT/AF Detection Off; Low; High
Mode AOO(R); AAI(R); AAT(R); VOO(R); VVI(R); Magnet Response Off; Low; High
VVT(R); VDD(R); DOO(R); DVI(R); DDI(R); High Atrial Rate Off; Low; High
DDD(R); Pacing Off Rate (bpm) 125-300 in steps of 25
Post-Ventricular Atrial Blanking (ms) 60-200 in steps of 10; 225; 250 No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
PVARP (ms) 125-500 in steps of 25 High Ventricular Rate Off; Low; High
Sensed AV Delay (ms) 25; 30-200 in steps of 10; 225-325 in steps of 25 Rate (bpm) 125-300 in steps of 25
Rest Rate (bpm) Off; 30-150 in steps of 5 No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Shortest AV Delay (ms) 25-50 in steps of 5; 60-120 in steps of 10 PMT Termination Off; Low; High
Ventricular Blanking (ms) Auto; 12-52 in steps of 4 Consecutive PVCs Off; Low; High
Ventricular Pace/Sense Refractory5 No. of Consecutive PVCs 2; 3; 4; 5
(Fixed) (ms) 125; 160-400 in steps of 30; 440; 4702 Noise Reversion Off; Low; High

Output/Sensing Other

Atrial Sensitivity (mV) 0.1-0.46 in steps of 0.1; 0.5; 0.75-2.0 in steps of 0.25; A and V Lead Monitoring Monitor; Auto Polarity Switch
2.5-4.0 in steps of 0.5; 5.07 A and V Low Impedance Limit (Ω) 100-500 in steps of 25
Ventricular AutoCapture™ A and V High Impedance Limit (Ω) 750-2500 in steps of 250; 3000
Pacing System On; Off Lead Type Uncoded; Unipolar; Bipolar
Primary Pulse Configuration Unipolar; Bipolar Magnet Response Off; Battery Test
Backup Pulse Configuration Unipolar; Bipolar Negative AV Hysteresis Search (ms) Off; -10 to -120 in steps of 10
Backup Pulse Amplitude (V) 5.03 NIPS Options
Search Interval (hours) 8; 24 Stimulation Chamber Atrial; Ventricular
AutoCapture Coupling Interval (ms) 100-800 in steps of 108
Paced/Sensed AV Delay (ms) 50/25; 100/70; 120/100 S1 Count 2-25 in steps of 1
Ventricular Sensitivity (mV) 0.5-5.0 in steps of 0.5; 6-10 in steps of 1.0; 12.57 S19; S2; S3 and S4 Cycle (ms) Off; 100-800 in steps of 10 (Fixed or Adaptive)
SenseAbility® Technology Off; On (Automatic Sensitivity Control adjustment for atrial Ventricular Support Rate (bpm) Off; 30-95 in steps of 5
and ventricular events) Sinus Node Recovery Delay (sec) 1; 2; 3; 4; 5
A Max Sensitivity (mV) 0.2-1.0 in steps of 0.1 PMT Options Off; Passive; Atrial Pace2
V Max Sensitivity (mV) 0.2-2.0 in steps of 0.1 PMT Detection Rate (bpm) 90-180 in steps of 5
Threshold Start (Atrial and Ventricular Post-Sense) 50; 62.5; 75; 100% PVC Response Off; Atrial Pace2
(Atrial Post-Pace) 0.2-3.0 in steps of 0.1 mV Ventricular Intrinsic
(Ventricular Post-Pace) Auto; 0.2-3.0 in steps of 0.1 mV Preference, VIP ® (ms) Off; 50-150 in steps of 25; 160-200 in steps of 10
Decay Delay (ms) (Atrial and Ventricular Post-Sense) 0; 30; 60; 95; 125; 160; 190; 220 VIP Search Interval 30 sec; 1; 3; 5; 10; 30 min
(Atrial Post-Pace) 0; 30; 60; 95; 125; 160; 190; 220 VIP Search Cycles 1; 2; 3
(Ventricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 Ventricular Safety Standby Off; On
Diagnostic Trends AT/AF Burden; Exercise & Activity; Lead Impedance;
Rate-Modulated Parameters P and R Wave; A and V Threshold
Patient Notifiers
Maximum Sensor Rate (bpm) 80-150 in steps of 5; 160-180 in steps of 10
Rate Responsive AV Delay Off; Low; Medium; High Programmable Notifiers (On; Off) Device at ERI; Atrial Lead Impedance Out of Range;
Rate Responsive PVARP/VREF Off; Low; Medium; High Ventricular Lead Impedance Out of Range; AT/AF Burden;
Reaction Time Very Fast; Fast; Medium; Slow AT/AF Episode Duration; High V Rate During AT/AF
Recovery Time Fast; Medium; Slow; Very Slow Device Reset On
Sensor On; Off; Passive Entry into Backup VVI Mode On
Shortest PVARP/VREF (ms) 125-475 in steps of 25 Audible Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Number of Audible Alerts
Auto (+3); 1-16 in steps of 1 per Notification 2
Threshold Auto (-0.5); Auto (+0.0); Auto (+0.5); Auto (+1.0); Number of Notifications 1-16
Auto (+1.5); Auto (+2.0); 1-7 in steps of 0.5 Time Between Notifications (hours) 10; 22
1 ± 0.5 cc
2 Programming options dependent on pacing mode.
3 This parameter is not programmable.
4 The highest available setting for hysteresis rate will be 5 min-1 below the programmed base rate.
5 In dual-chamber modes, the maximum ventricular refractory period is 325 ms.
6 Values 0.1-0.4 not available in a unipolar sense configuration.
7 Sensitivity is with respect to a 20 ms haversine test signal.
8 During atrial NIPS in dual-chamber modes, the shortest Coupling Interval will be limited by the programmed AV/PV delay.
9 S1 Burst Cycle is applied at the preprogrammed S1 cycle length.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Zephyr® DR
Dual-Chamber Pacemaker

Product Highlights
n ACap® Confirm feature periodically completes a threshold search and adjusts
the pulse amplitude accordingly in the atrium.
n The AutoCapture™ Pacing System offers the maximum in threshold
adaptability and patient safety with ventricular Beat-by-Beat™ capture
confirmation.
n Powerful tools to save valuable clinic time, including Automatic Daily
Measurements, Follow-Up EGM and Trends, Optimized In-Clinic Testing and
Lead Impedance Trend and Polarity Switch.
n Ventricular Intrinsic Preference (VIP®) algorithm automatically searches for
intrinsic conduction.
n Stored electrograms (EGMs) record a real-time EGM waveform as well as the
associated event markers that precede and follow a specific triggering event.

Ordering Information
Contents: Cardiac pulse generator

Model Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector

5820 43 x 44 x 6 18 8.5* IS-1

Indications and Usage: Implantation of Zephyr ® pulse generators is indicated in the following permanent patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond
conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, that of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively
disorientation, or any combination of those symptoms. Rate-Modulated Pacing is indicated for patients contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction,
with chronotropic incompetence,1 and for those who would benefit from increased stimulation rates or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial
concurrent with physical activity. Dual-Chamber Pacing (Models 5826, 5820 only) is indicated for Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction.
those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and third-degree AV block,
recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia For specific contraindications associated with individual modes, refer to Operating Modes.
and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction Potential Adverse Events: Adverse events associated with the use of any pacing system include: Air
and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients embolism, Bleeding Hematoma, Body rejection phenomena, Cardiac tamponade or perforation, Formation
with significant bradycardia and: Normal sinus rhythm with only rare episodes of A-V block or sinus of fibrotic tissue, local tissue reaction, Inability to interrogate or program due to programmer or device
arrest, chronic atrial fibrillation, severe physical disability. AF Suppression (Models 5826, 5820 only) malfunction, Infection/erosion, Interruption of desired pulse generator function due to electrical
is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or interference, either electromyogenic or electromagnetic, Lead malfunction due to conductor fracture or
more of the above pacing indications. For specific indications associated with individual modes, refer to insulation degradation, Loss of capture or sensing due to lead dislodgement or reaction at the electrode/
Operating Modes. tissue interface, Loss of desired pacing and/or sensing due to lead displacement, body reaction at
Contraindications: Implanted Cardioverter-Defibrillator (ICD). Because Zephyr ® pulse generators electrode interface, or lead malfunction (fracture or damage to insulation), Loss of normal device function
will be automatically programmed to a unipolar pulse configuration if the device initiates Backup VVI due to battery failure or component malfunction, Pacemaker migration, pocket erosion, or hematoma,
pacing, Zephyr devices are contraindicated in patients with an implanted cardioverter- defibrillator. Pectoral muscle or diaphragmatic stimulation, Phrenic nerve stimulation, Pneumothorax/hemothorax.
Rate-Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be adverse events.
selected based on assessment of the highest stimulation rate tolerated by the patient. AF Suppression
(Models 5826, 5820 only) stimulation is not recommended in patients who cannot tolerate high atrial- 1 Chronotropic incompetence has not been rigorously defined. A conservative approach, supported by the literature, defines
rate stimulation. Dual-Chamber Pacing (Models 5826, 5820 only) though not contraindicated for chronotropic.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Zephyr® DR
Dual-Chamber Pacemaker

Product Specifications
PHYSICAL SPECIFICATIONS AF Management
Model 5820
Dimensions (mm) 43 x 44 x 6 AF Suppression™ Algorithm Off; On
Weight (g) 18 Lower Rate Overdrive (bpm) 10∆
Volume (cc) 8.5* Upper Rate Overdrive (bpm) 5∆
Connector IS-1 No. of Overdrive Pacing Cycles 15-40 in steps of 5
Rate Recovery (ms) 8; 12 ∆
Maximum AF Suppression Rate (bpm) 80-150 in steps of 5, 160-180 in steps of 10
PARAMETER SETTINGS Atrial Tachycardia Detection Rate (bpm) 110-150 in steps of 5; 160-200 in steps of 10;
Rate/Timing 225-300 in steps of 25
Auto Mode Switch Off; DDDR to DDIR; DDD to DDI; VDDR to VVIR; VDD to VVI;
Atrial Absolute Refractory Period 60; 80; 100-350 in steps of 25 DDDR to DDI; DDD to DDIR; VDDR to VVI; VDD to VVIR
Atrial Protection Interval (ms) 125∆ AMS Base Rate (bpm) Base Rate +0 to Base Rate +35 in steps of 5
Paced AV Delay (ms) 25; 30-200 in steps of 10; 225-300 in steps of 25; 350
Base Rate (bpm) 30**; 40-130 in steps of 5; 140-170 in steps of 10 Stored Electrograms
Far-Field Protection Interval (ms) 16∆
Hysteresis Rate (bpm) Off; 30**-130 in steps of 5; 140; 150*** Options
Search Interval (min) Off; 5; 10; 15; 30 Sampling Options Freeze; Continuous
Cycle Count 1-16 in steps of 1 No. of Stored EGMs 1; 2; 4; 8; 12
Intervention Rate (bpm) Off; 60; 80-120 in steps of 10; Intrinsic +0; Channel Atrial; Ventricular; Dual; Cross-Channel
Intrinsic +10; Intrinsic +20; Intrinsic +30
Intervention Duration (min) 1-10 in 1 minute intervals Triggers
Recovery Time Fast; Medium; Slow; Very Slow Advanced Hysteresis On; Off
Maximum Tracking Rate (bpm) 90-130 in steps of 5; 140-180 in steps of 10 AMS Entry/AMS Exit On; Off
Mode AOO(R); AAI(R); AAT(R); OAO; VOO(R); VVI(R); AT/AF Detection On; Off
VVT(R); VDD(R); OVO; DOO(R); DVI(R); DDI(R); Magnet Placement On; Off
DDD(R); ODO High Atrial Rate Off 125; 150; 175; 200; 225; 250; 275; 300
PVARP (ms) 125-500 in steps of 25 No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Post Ventricular Atrial Blanking (ms) 60; 70; 80; 85; 95; 100; 110; 115; 125; 130; 140; 150; 155; 165; High Ventricular Rate Off 125; 150; 175; 200; 225; 250; 275; 300
170; 180; 185; 195; 200 No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Sensed AV Delay (ms) 25; 30-200 in steps of 10; 225-325 PMT Termination On; Off
in steps of 25 PVC Detection On; Off
Rest Rate (bpm) Off; 30-130 in steps of 5; 140; 150 No. of Consecutive PVCs 2; 3; 4; 5
Shortest AV Delay (ms) 30-50 in steps of 5; 60-120 in steps of 10
Ventricular Blanking (ms) Auto, 12-52 in steps of 4 Other
Ventricular Refractory (ms) 125-500 in steps of 25†
A and V Lead Monitoring Off, Monitor, Auto Polarity Switch
Output/Sensing A and V Low Impedance Limit (Ω) 200∆
A and V High Impedance Limit (Ω) 750, 1000, 1250, 1500, 1750, 2000
ACap® Confirm On; Off; Monitor Lead Type Uncoded; Unipolar; Bipolar Only; Unipolar/Bipolar
Primary Pulse Configuration Bipolar∆ Magnet Response Off; Battery Test
Backup Pulse Configuration Unipolar; Bipolar Negative AV Hysteresis Search (ms) Off; -10 to -110 in steps of 10
Backup Pulse Amplitude (V) 5.0∆ NIPS Options
Search Interval (hours) 8, 24 Stimulation Chamber Atrial; Ventricular
A or V Pulse Amplitude (V) 0.0-4.0 in steps of 0.25; 4.5-7.5 in steps of 0.5 Coupling Interval (ms) 100-800 in steps of 10 ◊
A or V Pulse Width (ms) 0.05; 0.1-1.5 in steps of 0.1 S1 Count 1-25 in steps of 1
A or V Pulse Configuration Unipolar (tip-case); Bipolar (tip-ring) S1 , S2, S3 and S4 Cycle (ms)
¥
100-800 in steps of 10
A or V Sense Configuration Unipolar Tip (tip-case); Bipolar (tip-ring); Ventricular Support Rate (bpm) Off, 30, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95
Unipolar Ring (ring-case) Sinus Node Recovery Delay (sec) 1, 2, 3, 4, 5
Atrial Sensitivity (mV) 0.1-0.4v, 0.5 by 0.1; 0.75-2.0 in steps of 0.25; 2.0-4.0 PMT Options Off; 10 Beats > PMT; Auto Detect
in steps of 0.5; 5.0‡ PMT Detection Rate (bpm) 90-150 in steps of 5; 160-180 in steps of 10
Ventricular AutoCapture™ Pacing System On; Off PVC Options Off; A Pace on PVC; +PVARP on PVC (VDD mode only)
Primary Pulse Configuration Unipolar; Bipolar Signal Amplitude Monitoring
Backup Pulse Configuration Unipolar; Bipolar P-Wave Monitoring Off, On
Backup Pulse Amplitude (V) 5.0∆ R-Wave Monitoring Off, On
Search Interval (hours) 8, 24 Ventricular Intrinsic Preference, VIP ® (ms) Off, 50-150 in steps of 25; 160-200 in steps of 10
AutoCapture Paced/Sensed AV Delay (ms) 50/25; 100/70; 120/100 VIP Search Interval 30 sec., 1, 3, 5, 10, 30 min.
Ventricular Sensitivity (mV) 0.5-5.0 in steps of 0.5; 6-10 in steps of 1.0; 12.5‡ VIP Search Cycles 1, 2, 3
Ventricular Safety Standby Off; On
Rate-Modulated Parameters * ± 0.5 cc
** The actual pacing rate for the 30 ppm is 31 ppm.
Maximum Sensor Rate (bpm) 80-150 in steps of 5; 160-180 in steps of 10 *** The highest available setting for Hysteresis Rate will be 5 ppm below the programmed Base Rate.
† In dual-chamber modes, the maximum Ventricular Refractory Period is 325 ms.
Rate Responsive AV Delay Off; Low; Medium; High ‡ Sensitivity is with respect to a 20 ms haversine test signal.
Rate Responsive PVARP/VREF Off; Low; Medium; High v Values 0.1-0.4 not available in a Unipolar Sense Configuration.
Reaction Time Very Fast; Fast; Medium; Slow ◊ During atrial NIPS in dual-chamber modes, the shortest Coupling Interval will be limited by the programmed AV/PV delay.
¥ S1 Burst Cycle is applied at the preprogrammed S1 cycle length.
Recovery Time Fast; Medium; Slow; Very Slow ∆ This parameter is not programmable.
Sensor On; Off; Passive
Shortest PVARP/VREF (ms) 120-350 in steps of 10
Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16
in steps of 1
Threshold Auto (-0.5); Auto (+0.0); Auto (+0.5); Auto (+1.0); Auto
(+1.5); Auto (+2.0); 1-7 in steps of 0.5

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Zephyr® XL DR
Dual-Chamber Pacemaker

Product Highlights
n ACap® Confirm feature periodically completes a threshold search and adjusts
the pulse amplitude accordingly in the atrium.
n The AutoCapture™ Pacing System offers the maximum in threshold
adaptability and patient safety with ventricular Beat-by-Beat™ capture
confirmation.
n Powerful tools to save valuable clinic time, including Automatic Daily
Measurements, Follow-Up EGM and Trends, Optimized In-Clinic Testing and
Lead Impedance Trend and Polarity Switch.
n Ventricular Intrinsic Preference (VIP®) algorithm automatically searches for
intrinsic conduction.
n Mean projected longevity of 13 years with AutoCapture Pacing On.

Ordering Information
Contents: Cardiac pulse generator

Model Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector

5826 44 x 52 x 6 23.5 11* IS-1 compatible §

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Zephyr® XL DR
Dual-Chamber Pacemaker

Product Specifications
PHYSICAL SPECIFICATIONS AF Management
Model 5826
Dimensions (mm) 44 x 52 x 6 AF Suppression™ Algorithm Off; On
Weight (g) 23.5 Lower Rate Overdrive (bpm) 10∆
Volume (cc) 11* Upper Rate Overdrive (bpm) 5∆
Connector IS-1 compatible § No. of Overdrive Pacing Cycles 15-40 in steps of 5
Rate Recovery (ms) 8; 12 ∆
Maximum AF Suppression Rate (bpm) 80-150 in steps of 5, 160-180 in steps of 10
PARAMETER SETTINGS Atrial Tachycardia Detection Rate (bpm) 110-150 in steps of 5; 160-200 in steps of 10;
Rate/Timing 225-300 in steps of 25
Auto Mode Switch Off; DDDR to DDIR; DDD to DDI; VDDR to VVIR; VDD to VVI;
Atrial Absolute Refractory Period 60; 80; 100-350 in steps of 25 DDDR to DDI; DDD to DDIR; VDDR to VVI; VDD to VVIR
Atrial Protection Interval (ms) 125∆ AMS Base Rate (bpm) Base Rate +0 to Base Rate +35 in steps of 5
Paced AV Delay (ms) 25; 30-200 in steps of 10; 225-300 in steps of 25; 350
Base Rate (bpm) 30**; 40-130 in steps of 5; 140-170 in steps of 10 Stored Electrograms
Far-Field Protection Interval (ms) 16∆
Hysteresis Rate (bpm) Off; 30**-130 in steps of 5; 140; 150*** Options
Search Interval (min) Off; 5; 10; 15; 30 Sampling Options Freeze; Continuous
Cycle Count 1-16 in steps of 1 No. of Stored EGMs 1; 2; 4; 8; 12
Intervention Rate (bpm) Off; 60; 80-120 in steps of 10; Intrinsic +0; Channel Atrial; Ventricular; Dual; Cross-Channel
Intrinsic +10; Intrinsic +20; Intrinsic +30
Intervention Duration (min) 1-10 in 1 minute intervals Triggers
Recovery Time Fast; Medium; Slow; Very Slow Advanced Hysteresis On; Off
Maximum Tracking Rate (bpm) 90-130 in steps of 5; 140-180 in steps of 10 AMS Entry/AMS Exit On; Off
Mode AOO(R); AAI(R); AAT(R); OAO; VOO(R); VVI(R); AT/AF Detection On; Off
VVT(R); VDD(R); OVO; DOO(R); DVI(R); DDI(R); Magnet Placement On; Off
DDD(R); ODO High Atrial Rate (bpm) Off 125; 150; 175; 200; 225; 250; 275; 300
Post Ventricular Atrial Blanking (ms) 60; 70; 80; 85; 95; 100; 110; 115; 125; 130; 140; No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
150; 155; 165; 170; 180; 185; 195; 200 High Ventricular Rate (bpm) Off 125; 150; 175; 200; 225; 250; 275; 300
PVARP (ms) 125-500 in steps of 25 No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Sensed AV Delay (ms) 25; 30-200 in steps of 10; 225-325 in steps of 25 PMT Termination On; Off
Rest Rate (bpm) Off; 30-130 in steps of 5; 140; 150 PVC Detection On; Off
Shortest AV Delay (ms) 30-50 in steps of 5; 60-120 in steps of 10 No. of Consecutive PVCs 2; 3; 4; 5
Ventricular Blanking (ms) Auto, 12-52 in steps of 4
Ventricular Refractory (ms) 125-500 in steps of 25† Other

Output/Sensing A and V Lead Monitoring Off, Monitor, Auto Polarity Switch

A and V Low Impedance Limit (Ω) 200∆
ACap® Confirm On; Off; Monitor A and V High Impedance Limit (Ω) 750, 1000, 1250, 1500, 1750, 2000
Primary Pulse Configuration Bipolar∆ Lead Type Uncoded; Unipolar; Bipolar Only; Unipolar/Bipolar
Backup Pulse Configuration Unipolar; Bipolar Magnet Response Off; Battery Test
Backup Pulse Amplitude (V) 5.0∆ Negative AV Hysteresis Search (ms) Off; -10 to -110 in steps of 10
Search Interval (hours) 8, 24 NIPS Options
A or V Pulse Amplitude (V) 0.0-4.0 in steps of 0.25; 4.5-7.5 in steps of 0.5 Stimulation Chamber Atrial; Ventricular
A or V Pulse Width (ms) 0.05; 0.1-1.5 in steps of 0.1 Coupling Interval (ms) 100-800 in steps of 10 ◊
A or V Pulse Configuration Unipolar (tip-case); Bipolar (tip-ring) S1 Count 1-25 in steps of 1
A or V Sense Configuration Unipolar Tip (tip-case); Bipolar (tip-ring); S1 , S2, S3 and S4 Cycle (ms)
¥
100-800 in steps of 10
Unipolar Ring (ring-case) Ventricular Support Rate (bpm) Off, 30, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95
Atrial Sensitivity (mV) 0.1-0.4v, 0.5 by 0.1; 0.75-2.0 in steps of 0.25; 2.0-4.0 Sinus Node Recovery Delay (sec) 1, 2, 3, 4, 5
in steps of 0.5; 5.0‡ PMT Options Off; 10 Beats > PMT; Auto Detect
Ventricular AutoCapture™ Pacing System On; Off PMT Detection Rate (bpm) 90-150 in steps of 5; 160-180 in steps of 10
Primary Pulse Configuration Unipolar; Bipolar PVC Options Off; A Pace on PVC; +PVARP on PVC (VDD mode only)
Backup Pulse Configuration Unipolar; Bipolar Signal Amplitude Monitoring
Backup Pulse Amplitude (V) 5.0∆ P-Wave Monitoring Off, On
Search Interval (hours) 8, 24 R-Wave Monitoring Off, On
AutoCapture Paced/Sensed AV Delay (ms) 50/25; 100/70; 120/100 Ventricular Intrinsic Preference, VIP ® (ms) Off, 50-150 in steps of 25; 160-200 in steps of 10
Ventricular Sensitivity (mV) 0.5-5.0 in steps of 0.5; 6-10 in steps of 1.0; 12.5‡ VIP Search Interval 30 sec., 1, 3, 5, 10, 30 min.
VIP Search Cycles 1, 2, 3
Rate-Modulated Parameters Ventricular Safety Standby Off; On
* ± 0.5 cc
Maximum Sensor Rate (bpm) 80-150 in steps of 5; 160-180 in steps of 10 ** The actual pacing rate for the 30 ppm is 31 ppm.
Rate Responsive AV Delay Off; Low; Medium; High *** The highest available setting for Hysteresis Rate will be 5 ppm below the programmed Base Rate.
† In dual-chamber modes, the maximum Ventricular Refractory Period is 325 ms.
Rate Responsive PVARP/VREF Off; Low; Medium; High ‡ Sensitivity is with respect to a 20 ms haversine test signal.
Reaction Time Very Fast; Fast; Medium; Slow v Values 0.1-0.4 not available in a Unipolar Sense Configuration.
Recovery Time Fast; Medium; Slow; Very Slow ◊ During atrial NIPS in dual-chamber modes, the shortest Coupling Interval will be limited by the programmed AV/PV delay.
¥ S1 Burst Cycle is applied at the preprogrammed S1 cycle length.
Sensor On; Off; Passive ∆ This parameter is not programmable.
Shortest PVARP/VREF (ms) 120-350 in steps of 10 § Accepts all IS-1, VS•1, and 3.2 mm leads.
Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16
in steps of 1
Threshold Auto (-0.5); Auto (+0.0); Auto (+0.5); Auto (+1.0); Auto
(+1.5); Auto (+2.0); 1-7 in steps of 0.5

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Accent® SR
Single-Chamber Pacemaker

Product Highlights
n Inductive remote follow-up utilizing a wand, in conjunction with the
Merlin@home® transmitter and Merlin.net® Patient Care Network(PCN),
allows patients to download information and provide the clinic with access to
device measurements.
n A two-tone audible alert allows programming to notify the patient of changes in
device performance or arrhythmia status, which can provide earlier insight into
actionable clinical events.
n Ventricular AutoCapture™ Pacing System offers the maximum in threshold
adaptability and patient safety with ventricular Beat-by-Beat™ capture
confirmation. The Ventricular AutoCapture Pacing System automatically delivers
a 5.0 V backup safety pulse when noncapture is detected, and it may be
programmed to either a bipolar or unipolar configuration.
n Exclusive SenseAbility ® feature, with Decay Delay and Threshold Start, provides
the flexibility to fine-tune sensing to individual patient needs and help eliminate
oversensing of T waves, fractionated QRS complexes and other extraneous signals.
n Real-time electrogram (EGM) waveform, as well as the associated event markers
that precede and follow a specific triggering event, can be programmed to
automatically record up to 14 minutes of stored EGMs when encountering one
or more programmable trigger options.
n Weekly Lead Impedance Trend displays the current measurement, historical
test results, pacing polarity and any polarity switches.

Ordering Information
Contents: Cardiac pulse generator

Model Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector

PM1110 42 x 52 x 6 18 9.5 (± 0.5 cc) IS-1

Indications: Implantation is indicated in one or more of the following permanent conditions: syncope, Potential Adverse Events: The following are potential complications associated with the use of any
presyncope, fatigue, disorientation due to arrhythmia/bradycardia, or any combination of those symptoms. pacing system: air embolism, body rejection phenomena, cardiac tamponade or perforation, hematoma,
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those bleeding hematoma, seroma, formation of fibrotic tissue, local tissue reaction, inability to interrogate
who would benefit from increased stimulation rates concurrent with physical activity. Atrial Pacing or program due to programmer or device malfunction, infection/erosion, interruption of desired pulse
is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction generator function due to electrical interference, either electromyogenic or electromagnetic, lead
systems. Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus malfunction due to conductor fracture or insulation degradation, loss of capture or sensing due to lead
rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical dislodgement or reaction at the electrode/tissue interface, loss of desired pacing and/or sensing due
disability. to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to
insulation), loss of normal device function due to battery failure or component malfunction, pacemaker
Contraindications: Implanted Cardioverter-Defibrillator (ICD). Devices are contraindicated in patients migration or pocket erosion, pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation,
with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients pneumothorax/hemothorax, device migration and pocket erosion, endocarditis, excessive bleeding,
who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An induced atrial or ventricular arrhythmias, myocardial irritability, pericardial effusion, pericardial rub,
appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation pulmonary edema, rise in threshold and exit block, valve damage.
rate tolerated by the patient. Single-Chamber Ventricular Demand Pacing is relatively contraindicated
in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial Pacing is adverse events.
relatively contraindicated in patients who have demonstrated compromise of AV conduction. For specific
contraindications associated with individual modes, refer to the programmer’s on-screen help.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Accent® SR
Single-Chamber Pacemaker

Product Specifications
PHYSICAL SPECIFICATIONS Stored Electrograms
Model PM1110 Options
Telemetry Inductive Priority Options Off; Low; High
Dimensions (mm) 42 x 52 x 6 Channel 1; 2; 3
Weight (g) 18 Triggers
Volume (cc) 9.51 Magnet Response Off; Low; High
Connector IS-1 High Ventricular Rate Off; Low; High
Rate (bpm) 125-300 in steps of 25
PARAMETER SETTINGS No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Rate/Timing Advanced Hysteresis Off; Low; High
Noise Reversion Off; Low; High
Ventricular Pace/Sense Refractory
(Fixed) (ms) 125; 160-400 in steps of 30; 440; 4702 Other
Base Rate (bpm) 30-130 in steps of 5; 140-170 in steps of 10
Mode VOO(R); VVI(R); VVT(R); Pacing Off Lead Monitoring Monitor; Auto Polarity Switch
Hysteresis Rate (bpm) Off; 30-150 in steps of 53 V Low Impedance Limit (Ω) 100-500 in steps of 225
Search Interval (bpm) Off; 1; 5; 10; 15; 30 V High Impedance Limit (Ω) 750-2500 in steps of 250; 3000
Cycle Count 1-16 by 1 Magnet Response Off; Battery Test
Intervention Rate (bpm) Off; Same Basic Rate; 80-120 in steps of 10 (Intrinsic +0; Lead Type Uncoded; Unipolar; Bipolar
Intrinsic +10; Intrinsic +20; Intrinsic +30); Same as Base Rate NIPS Options
Intervention Duration (min) 1-10 in 1-minute intervals Stimulation Chamber Ventricular
Recovery Time Fast; Medium; Slow; Very Slow Coupling Interval (ms) 100-800 in steps of 10
Rest Rate (bpm) Off; 30-150 in steps of 5 S1 Count 2-25 in steps of 1
S16 ; S2; S3 and S4 Cycle (ms) 100-800 in steps of 10 (Fixed or Adaptive)
Output/Sensing Diagnostic Trends Exercise & Activity; Lead Impedance; R Wave; V Threshold

V Pulse Amplitude (V) 0.25-4.0 in steps of 0.25; 4.5-7.5 in steps of 0.5 Patient Notifiers
V Pulse Width (ms) 0.05; 0.1-1.5 in steps of 0.1
V Sensitivity (mV) 0.5-5.0 in steps of 0.5; 6-10 in steps of 1.0; 12.5 4 Programmable Notifiers (On; Off) Device at ERI; Ventricular Lead Impedance Out of Range
Device Reset On
V Pulse Configuration Unipolar (tip-case); Bipolar (tip-ring)
Entry into Backup VVI Mode On
V Sense Configuration Unipolar Tip (tip-case); Bipolar (tip-ring); Unipolar Ring (ring-case) Audible Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
Ventricular AutoCapture™ Number of Audible Alerts
Pacing System On; Off per Notification 2
Primary Pulse Configuration Unipolar; Bipolar Number of Notifications 1-16
Backup Pulse Configuration Unipolar; Bipolar Time Between Notifications (hours) 10; 22
Backup Pulse Amplitude (V) 5.05
Search Interval (hours) 8; 24
SenseAbility® Technology Off; On (Automatic Sensitivity Control adjustment for
ventricular events)
Max Sensitivity (mV) 0.2-2.0 in steps of 0.1
Threshold Start (Ventricular Post-Sense) 50; 62.5; 75; 100%
(Ventricular Post-Pace) Auto; 0.2-3.0 in steps of 0.1 mV
Decay Delay (ms) (Ventricular Post-Sense) 0; 30; 60; 95; 125; 160; 190; 220
(Ventricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220
Rate-Modulated Parameters

Maximum Sensor Rate (bpm) 80-150 in steps of 5; 160-180 in steps of 10

Rate Responsive VREF Off; Low; Medium; High
Shortest VREF 125-475 in steps of 25
Reaction Time Very Fast; Fast; Medium; Slow
Recovery Time Fast; Medium; Slow; Very Slow
Sensor On; Off; Passive
Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 in steps of 1
Threshold Auto (-0.5); Auto (+0.0); Auto (+0.5); Auto (+1.0); Auto (+1.5);
Auto (+2.0); 1-7 in steps of 0.5

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Accent® SR RF
Single-Chamber Pacemaker

Product Highlights
n InvisiLink® Wireless Telemetry, in conjunction with the Merlin@home® transmitter
and Merlin.net® Patient Care Network (PCN), allows for daily remote monitoring
and follow-up.
n A two-tone audible alert allows programming to notify the patient of changes in
device performance, or information can be remotely transmitted to the clinician
through the Merlin.net PCN without patient interaction.
n AutoCapture™ Pacing System offers the maximum in threshold adaptability
and patient safety with ventricular Beat-by-Beat™ capture confirmation. The
AutoCapture Pacing System automatically delivers a 5.0 V backup safety pulse
when noncapture is detected, and it may be programmed to either a bipolar or
unipolar configuration.
n E xclusive SenseAbility ® feature, with Decay Delay and Threshold Start, provides
the flexibility to fine-tune sensing to individual patient needs and help eliminate
oversensing of T waves, fractionated QRS complexes and other extraneous signals.
n Real-time electrogram (EGM) waveform, as well as the associated event markers
that precede and follow a specific triggering event, can be programmed to
automatically record up to 14 minutes of stored EGMs when encountering one or
more programmable trigger options.
n Weekly Lead Impedance Trend displays the current measurement, historical test
results, pacing polarity and any polarity switches.

Ordering Information
Contents: Cardiac pulse generator

Model Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector

PM1210 52 x 52 x 6 23 12.8 (± 0.5 cc) IS-1

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Accent® SR RF
Single-Chamber Pacemaker

Product Specifications
PHYSICAL SPECIFICATIONS Stored Electrograms
Model PM1210 Options
Telemetry RF Priority Options Off; Low; High
Dimensions (mm) 52 x 52 x 6 Channel 1; 2; 3
Weight (g) 23 Triggers
Volume (cc) 12.81 Magnet Response Off; Low; High
Connector IS-1 High Ventricular Rate Off; Low; High
Rate (bpm) 125-300 in steps of 25
PARAMETER SETTINGS No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Rate/Timing Advanced Hysteresis Off; Low; High
Noise Reversion Off; Low; High
Ventricular Pace/Sense Refractory
(Fixed) (ms) 125; 160-400 in steps of 30; 440; 4702 Other
Base Rate (bpm) 30-130 in steps of 5; 140-170 in steps of 10
Mode VOO(R); VVI(R); VVT(R); Pacing Off Lead Monitoring Monitor; Auto Polarity Switch
Hysteresis Rate (bpm) Off; 30-150 in steps of 53 V Low Impedance Limit (Ω) 100-500 in steps of 225
Search Interval (bpm) Off; 1; 5; 10; 15; 30 V High Impedance Limit (Ω) 750-2500 in steps of 250; 3000
Cycle Count 1-16 by 1 Magnet Response Off; Battery Test
Intervention Rate (bpm) Off; Same Basic Rate; 80-120 in steps of 10 (Intrinsic +0; Lead Type Uncoded; Unipolar; Bipolar
Intrinsic +10; Intrinsic +20; Intrinsic +30); Same as Base Rate NIPS Options
Intervention Duration (min) 1-10 in 1-minute intervals Stimulation Chamber Ventricular
Recovery Time Fast; Medium; Slow; Very Slow Coupling Interval (ms) 100-800 in steps of 10
Rest Rate (bpm) Off; 30-150 in steps of 5 S1 Count 2-25 in steps of 1
S16 ; S2; S3 and S4 Cycle (ms) 100-800 in steps of 10 (Fixed or Adaptive)
Output/Sensing Diagnostic Trends Exercise & Activity; Lead Impedance; R Wave; V Threshold

V Pulse Amplitude (V) 0.25-4.0 in steps of 0.25; 4.5-7.5 in steps of 0.5 Patient Notifiers
V Pulse Width (ms) 0.05; 0.1-1.5 in steps of 0.1
V Sensitivity (mV) 0.5-5.0 in steps of 0.5; 6-10 in steps of 1.0; 12.5 4 Programmable Notifiers (On; Off) Device at ERI; Ventricular Lead Impedance Out of Range
Device Reset On
V Pulse Configuration Unipolar (tip-case); Bipolar (tip-ring)
Entry into Backup VVI Mode On
V Sense Configuration Unipolar Tip (tip-case); Bipolar (tip-ring); Unipolar Ring (ring-case) Audible Duration (sec) 2; 4; 6; 8; 10; 12; 14; 16
Ventricular AutoCapture™ Number of Audible Alerts
Pacing System On; Off per Notification 2
Primary Pulse Configuration Unipolar; Bipolar Number of Notifications 1-16
Backup Pulse Configuration Unipolar; Bipolar Time Between Notifications (hours) 10; 22
Backup Pulse Amplitude (V) 5.05 1 ± 0.5 cc
Search Interval (hours) 8; 24 2 Programming options dependent on pacing mode.
SenseAbility® Technology Off; On (Automatic Sensitivity Control adjustment for 3 The highest available setting for hysteresis rate will be 5 min-1 below the programmed base rate.
4 Sensitivity is with respect to a 20 ms haversine test signal.
ventricular events) 5 This parameter is not programmable.
Max Sensitivity (mV) 0.2-2.0 in steps of 0.1 6 S1 Burst Cycle is applied at the preprogrammed S1 cycle length.
Threshold Start (Ventricular Post-Sense) 50; 62.5; 75; 100%
(Ventricular Post-Pace) Auto; 0.2-3.0 in steps of 0.1 mV
Decay Delay (ms) (Ventricular Post-Sense) 0; 30; 60; 95; 125; 160; 190; 220
(Ventricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220
Rate-Modulated Parameters

Maximum Sensor Rate (bpm) 80-150 in steps of 5; 160-180 in steps of 10

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Microny® II SR+
Single-Chamber Pacemaker

Product Highlights
n The Beat-by-Beat™ AutoCapture™ Pacing System is a capture verification
algorithm that allows the pacemaker to deliver an output pulse 0.3 V above
the measured capture threshold, thus minimizing battery drain.
n Automatic P/R Sensitivity Test suggests a programmed value for the
P/R sensitivity.
n Accelerometer sensor provides reliable rate response with only one
programmable parameter (Slope).
n Beat-by-Beat Lead Impedance Monitoring.
n Comprehensive diagnostics and management tools, including Measured Data,
Rate Prediction Model, Stimulation Threshold vs. Time, Sensor Indicated Rate
vs. Time and others.

Ordering Information
Contents: Cardiac pulse generator

Model Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector

2525T 33 x 33 x 6 12.8 5.9 IS-1 bipolar

Indications and Usage: The pulse generators are indicated for: Accepted Patient Conditions warranting pacing in patients with an implanted cardioverter-defibrillator (ICD) since it may inhibit or trigger ICD
chronic cardiac pacing, which include: sick sinus syndrome, chronic, symptomatic second- and third- therapy. The pulse generators are programmed to unipolar pacing and may be inappropriate for patients
degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when with an ICD.
tachy-arrhythmia and other causes have been ruled out.
Potential Adverse Events: Adverse events associated with the use of any pacing system include: air
Atrial Pacing in patients with sinus node dysfunction and normal AV and intraventricular conduction embolism, bleeding/hematoma, body rejection phenomena, cardiac tamponade or perforation, formation
systems. Ventricular Pacing in patients with significant bradycardia and: of fibrotic tissue; local tissue reaction, Inability to interrogate or program due to programmer or device
malfunction, infection/erosion, interruption of desired pulse generator function due to electrical
normal sinus rhythm with only rare episodes of A-V block or sinus arrest requiring short periods of pacing interference, either electromyogenic or electromagnetic, lead malfunction due to conductor fracture or
support, chronic atrial fibrillation, severe physical disability. insulation degradation, loss of capture or sensing due to lead dislodgment or reaction at the electrode/
Rate-Modulated Pacing in patients who would benefit from increased pacing rates concurrent with tissue interface, loss of desired pacing and/or sensing due to lead displacement, body reaction at
physical activity. electrode interface, or lead malfunction (fracture or damage to insulation), loss of normal device function
due to battery failure or component malfunction, pacemaker migration, pocket erosion, or hematoma,
Contraindications: The pulse generators are contraindicated for: single-Chamber Ventricular Demand pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation, pneumothorax/hemothorax.
Pacing in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or who
suffer a drop in arterial blood pressure with the onset of ventricular pacing, single-Chamber Atrial Pacing Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
in patients who have demonstrated compromise of AV conduction, rate-Modulated Pacing in patients who adverse events.
experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates, unipolar

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Microny® II SR+
Single-Chamber Pacemaker

Product Specifications
PHYSICAL SPECIFICATIONS
Model 2525T
Dimensions (mm) 33 x 33 x 6
Weight (g) 12.8
Volume (cc) 5.9
Connector IS-1 Bipolar
Battery Data Lithium-iodine cell, 2.80 V/0.35 Ah

PARAMETER SETTINGS
Rate/Timing

Mode AOO(R); AAI(R); AAT(R); VOO(R); VVI*(R); VVT(R)

Basic Rate (ppm) 45 - 160 in steps of 5; 60*
Hysteresis Rate (ppm) 0, 10, 20, 30 below the basic or sensor-indicated rate; Off*
Refractory Period (ms) 250, 300*, 350, 400, 450, 500, 550

Output/Sensing

Pulse Amplitude (V) Auto** 0.3 - 4.5 in steps of 0.3; 2.4*

Pulse Width (ms) 0.03; 0.06; 0.09; 0.12; 0.15; 0.18; 0.21; 0.24; 0.31*; 0.37; 0.43;
0.49; 0.58; 0.70; 0.82; 1.0
P/R Sensitivity (mV) 0.5; 0.8; 1.2; 2.0; 3.0*; 5.0; 7.5; 12
ER Sensitivity (mV) 1.6; 2.5; 4.0*; 6.0; 10.0; 15.0; 24.0
Pulse Polarity Configuration Unipolar
Sense Polarity Configuration Bipolar

Rate-Modulated Parameters

VARIO On, Off*

Ventricular AutoCapture™ Pacing System On; Off*
Sensor On; Off; Passive
Maximum Sensor Rate (ppm)*** 90 - 160 in steps of 10; 130*
Slope*** 1 - 16 in steps of 1; 10*
Reaction Time*** Very Fast; Fast; Medium*; Slow; Very Slow
Recovery Time*** Very Fast; Fast; Medium*; Slow; Very Slow
Fast Response*** On, Off*
* Standard/Nominal settings.
** Only with AutoCapture ON.
*** Inactive. Activate by programming the sensor ON or PASSIVE.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Microny® K SR
Single-Chamber Pacemaker

Product Highlights
n Automatic P/R Sensitivity Test suggests a programmed value for the
P/R sensitivity.
n Accelerometer sensor provides reliable rate response with only one
programmable parameter (Slope).
n Features for fine-tuning the rate response, including Rate Prediction Model,
Reaction Time, Recovery Time and Fast Response.
n Beat-by-Beat Lead Impedance Monitoring.
n Comprehensive diagnostics and management tools, including Measured Data,
Rate Prediction Model, Sensor Indicated Rate vs. Time, Event Markers
and others.

Ordering Information
Contents: Cardiac pulse generator

Model Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector

2535K 33 x 33 x 6 12.8 5.9 IS-1 unipolar

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Microny® K SR
Single-Chamber Pacemaker

Product Specifications
PHYSICAL SPECIFICATIONS
Model 2535K
Dimensions (mm) 33 x 33 x 6
Weight (g) 12.8
Volume (cc) 5.9
Connector IS-1 Unipolar
Battery Data Lithium-iodine cell, 2.80 V/0.35 Ah

PARAMETER SETTINGS
Rate/Timing

Mode AOO(R); AAI(R); AAT(R); VOO(R); VVI*(R); VVT(R)

Basic Rate (ppm) 45 - 160 in steps of 5; 60*
Hysteresis Rate (ppm) 0, 10, 20, 30 below the basic or sensor-indicated rate; Off*
Refractory Period (ms) 250, 300*, 350, 400, 450, 500, 550

Output/Sensing

Pulse Amplitude (V) 0.3 - 4.5 in steps of 0.3; 2.4*

Pulse Width (ms) 0.03; 0.06; 0.09; 0.12; 0.15; 0.18; 0.21; 0.24; 0.31*; 0.37; 0.43;
0.49; 0.58; 0.70; 0.82; 1.0
P/R Sensitivity (mV) 0.5; 0.8; 1.2; 2.0; 3.0*; 5.0; 7.5; 12
Pulse Polarity Configuration Unipolar
Sense Polarity Configuration Unipolar

Rate-Modulated Parameters

VARIO On, Off*

Sensor Of; Off; Passive
Maximum Sensor Rate (ppm)** 90 - 160 in steps of 10; 130*
Slope** 1 - 16 in steps of 1; 10*
Reaction Time** Very Fast; Fast; Medium*; Slow; Very Slow
Recovery Time** Very Fast; Fast; Medium*; Slow; Very Slow
Fast Response** On; Off*
* Standard/Nominal settings.
** Inactive. Activate by programming the sensor ON or PASSIVE.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page PM16
External Pulse Generators
External Pulse Generators

Model 3085 External (Temporary) Pulse Generator

Dual-Chamber External Pulse Generator

Product Highlights
n Designed for safe and reliable temporary stimulation of the heart in cases of
rhythm disturbances and conduction defects, and/or perioperative temporary heart
stimulation.
n An extensive dual-chamber feature set, including a full array of mode choices, atrial
auto-sensing, completely adjustable stimulation parameters, a wide base rate range,
and a max tracking rate of 80-230 ppm.
n Continuous, independent atrial and ventricular lead surveillance and an audible
warning in the event of lead malfunction.
n The Auto Mode Switch/Noise Reversion feature responds to signals faster than 273
ppm with reversion to a non-tracking or asynchronous mode.
n Rapid atrial pacing rates (up to 1000 ppm) are available for pace-termination of atrial
tachycardia.
n Additional safety features:
– Stimulation is maintained for 30 seconds during battery changes.
– The Lock/Unlock feature prevents unintentional program changes.
– The Emergency Key feature immediately switches the Model 3085 temporary
pacemaker to VOO or AOO pacing at a rate of 80 ppm, with output settings of 12 V
or set value when higher, and a pulse width of 0.75 ms (VOO) or 1.0 ms (AOO), or
set value when longer.
n Designed for ease of use:
– Standard 9 volt lithium or alkaline batteries are used, and the device features both
visual and audible battery life indicators.
– A straightforward graphical user interface and simple controls.
– Small size and lightweight design.

Ordering Information
Contents: External pulse generator

Model Number Dimensions (H x W x T, cm) Weight (g) Battery

3085 20 x 9.6 x 3.8 490 (includes battery) Standard 9 V, alkaline or lithium

Indications for Use: The Model 3085 external pulse generator/temporary pacemaker is designed - Postoperatively after cardiac surgery;
to be used with cardiac stimulation lead systems for temporary atrial, ventricular or A V sequential - T emporary application during implantation or exchange of a permanent pacemaker.
stimulation. The Model 3085 has applications where such stimulation modes are indicated for therapeutic, Indication for atrial overdrive stimulation:
prophylactic, or diagnostic purposes. - Supraventricular tachycardia.
Specific indications include, but are not limited to, the following:
- Sick sinus syndrome; Contraindications: There are no contraindications with regards to the use of the Model 3085 for
- Bradycardia with congestive heart failure; temporary cardiac stimulation for therapy and prevention of arrhythmia. The state of health of the patient,
- Complete heart block; however, can restrict the choice of operational mode and stimulation parameters. For example, a mode
- Acute myocardial infarction complicated with heart block; of operation with atrial sensing is not suitable or appropriate when atrial fibrillation occurs. This is due
- Sinus bradycardia; to excessive and chaotic frequency of detected fibrillation waves. Overdrive-stimulation therapy must
- Cardiac arrest with ventricular asystole; only be used in the atrium. Overdrive-stimulation in the ventricle could cause life threatening ventricular
- Atrial and/or ventricular ectopic arrhythmia; fibrillation

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Model 3085 External (Temporary) Pulse Generator

Dual-Chamber External Pulse Generator

Product Specifications
PHYSICAL SPECIFICATIONS
Model 3085
Battery Standard 9 V, alkaline or lithium
Battery Life Alkaline Minimal 10 days (VVI, standard parameters),
Minimal 8 days (DDD, standard parameters)
Plus 1 day reserve after the first appearance of the battery change
message
Battery Life Lithium Minimal 19 days (VVI, standard parameters)
Minimal 15 days (DDD, standard parameters)
Plus 1 day reserve after the first appearance of the battery change
message
Weight (g) Approximately 490 (including battery)
Size (cm) 20 x 9.6 x 3.8 (7.75 in. x 4 in. x 1.5 in.)

PARAMETER SETTINGS
Modes DDD, DDD + AT, DOO, DAT, DVI, DAI, VVI, VOO, VAT, AAI, AOO, AAT, VDD
Base Pacing Rates (ppm) 30-220
Upper Pacing Rates (MTR) (ppm) 80-230
Rapid Atrial Pacing Rates (ppm) 70-1000
AV Delay (ms) 5-400 (minimum 30 ms when atrial Auto Sense is activated)
PV Delay (ms) AV delay-30 (minimum 5 ms when atrial Auto Sense is not activated,
minimum 30 when atrial Auto Sense is activated)
Pulse Duration (ms) 0.05-1.50
Pulse Amplitude (V) 0.1-18
Atrial Sensitivity (mV) 0.2-20
Ventricular Sensitivity (mV) 1.0-20
Blanking Period (ms) 85 (atrial & ventricular), 55 (ventricular after atrial pacing)
Atrial Refractory Period (ms) 250 … 400 ms ± 5% (AAI, AAT), A-V interval plus PVARP
(DDD, VDD, DAI, VAT, DAT)
PVARP (ms) 100-500 (absolute: 90 ms, relative: 90 ms)
Ventricular Refractory Period (ms) 250
Extended PVARP (After PVC) (ms) 500
Crosstalk Detection Window (ms) 40
Emergency Mode V00 (A00), 80 ppm, 12 V or set value when higher, 0.75 ms (1.00 ms)
or set value when longer
Runaway Protection (ppm) 235

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Model 3077 External (Temporary) Pulse Generator

Single-Chamber External Pulse Generator

Product Highlights
n Designed for safe and reliable temporary stimulation of the heart in cases of rhythm
disturbances and conduction defects.
n An extensive single-chamber feature set, including mode choices, a wide base rate
range, adjustable amplitude and sensitivity parameters, and two modes of high-rate
pacing.
n Up to 12 volts of output available per channel make the Model 3077 temporary
pacemaker one of the highest-output devices of its kind available.
n Designed for ease of use:
– Standard 9 volt lithium or alkaline batteries are used, and the device features both
visual and audible battery life indicators.
– Large, simple dial.
– Small size and lightweight design.
n Runaway protection limits the device to a maximum rate of 200 ppm in the unlikely
event of circuit malfunction.

Ordering Information
Contents: External pulse generator

Model Number Dimensions (H x W x T, cm) Weight (g) Battery

3077 6 x 11.5 x 2.2 185 (includes battery) Standard 9 V, alkaline or lithium

Indications for Use: When combined with a stimulation lead system, the Model 3077 SSI temporary pulse Contraindications: The Model 3077 SSI temporary pulse generator is contraindicated:
generator can be used whenever temporary atrial or ventricular stimulation is indicated. The device can be - In the treatment of ventricular tachycardia
employed for therapeutic as well as diagnostic purposes or be used prophylactically. -W hen overall physiological condition of the patient limits the selection of the stimulation mode and the
Some specific indications for temporary stimulation are: stimulation parameters.
- Complete (third-degree) or intermittent heart block
- Symptomatic sinus bradycardia
- Atrial or ventricular ectopic arrhythmia
- Sick sinus syndrome (SSS)
- Atrial tachyarrhythmia
- Acute myocardial infarction induced heart block
- Stimulation during a ventricular asystole
- Usage during the replacement of an implantable pacemaker
- Stimulation and monitoring before the implantation of a cardiac pacemaker
- Stimulation and monitoring following heart surgery

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Model 3077 External (Temporary) Pulse Generator

Single-Chamber External Pulse Generator

Product Specifications
PHYSICAL SPECIFICATIONS
Model 3077
Battery Alkaline-38 days (72 ppm, 8.0 V), Lithium-53 days (72 ppm, 8.0 V)
Weight (g) Approximately 185 (including battery)
Size (cm) 6.0 x 11.5 x 2.2 (2.25 in. x 4.5 in. x .85 in.)

PARAMETER SETTINGS
Modes VVI, VOO, AAI, AOO
Base Pacing Rates (ppm) 30-180
High Pacing Rates (ppm) 360-720
Pulse Width (ms) 0.75
Pulse Amplitude (V) 0.3-12
Sensitivity (mV) 1.0-20
Refractory Period (ms) 250
Runaway Protection (ppm) 200

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Tendril® SDX
Pacing Lead

Product Highlights
n Improved fluoroscopic visibility, Traffic-Light™ stylet configuration (red = extra
firm; yellow = firm; green = soft), active mapping collar and multiple lengths
for convenience.
n Radiopaque suture sleeve, ultra-thin lead body and Fast-Pass® coating for
easy implantation.
n Steroid elution and titanium nitride fractal coating on electrodes for low
thresholds.
n Shorter tip-to-ring spacing and silicone insulation for high performance and
reliability.

Ordering Information
Contents: Cardiac pacing lead

Model Number Insulation Fixation Min. Introducer (F) Connector Lengths (cm)
1688TC Silicone rubber Ext/Ret Helix 7 IS-1 bipolar 58

Indications: The Tendril® SDX lead is designed for permanent sensing and pacing in either the atrium or Adverse Events: Potential complications associated with the use of Tendril® ST leads are the same as
the ventricle, in combination with a compatible pulse generator. An active lead, such as the Tendril SDX, with the use of other active fixation leads and include: cardiac tamponade, diaphragmatic stimulation,
may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In embolism, excessive bleeding, induced ventricular ectopy, infection, loss of pacing and/or sensing due
atrial applications, the use of a screw-in lead, such as the Tendril SDX, may be indicated in the presence to dislodgment or mechanical malfunction of the pacing lead, phrenic nerve stimulation, thrombosis.
of an abnormal, surgically altered or excised atrial appendage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax,
laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation
Contraindications: The Tendril® SDX lead is contraindicated: In the presence of tricuspid atresia, for of other vessels, massive hemorrhage and, rarely, death.
patients with mechanical tricuspid valves, in patients who are expected to be hypersensitive to a single
dose of one milligram of dexamethasone sodium phosphate. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
adverse events.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Tendril® SDX
Pacing Lead

Product Specifications
PHYSICAL SPECIFICATIONS
Model 1688TC
Lead Connector IS-1 Bipolar
Length 58 cm
Minimum Introducer Size 7F
Type of Lead Transvenous, screw-in, bipolar, steroid
Fixation Mechanism Extendable/Retractable helix (3 facet)
External Lead Body Diameter 0.081”/2.1 mm (6.2 F)
Tip-to-Ring Spacing 10 mm
Lead Tip Electrode (Cathode) Pt/Ir collar + active titanium nitride coated Pt/Ir helix
(1.8 mm extension)
Tip Electrode Surface Area 8 mm2 (collar: 2.4 mm2; helix: 5.6 mm2)
Ring Electrode (Anode) Titanium nitride coated Pt/Ir ring
Ring Electrode Surface Area 16 mm2
Mapping Available with collar
Steroid ≤ 1 mg dexamethasone sodium phosphate
Inner Conductor MP35N coil
Inner Insulation Silicone rubber
Outer Conductor MP35N coil
Outer Insulation Silicone rubber

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Tendril® ST Optim®
Pacing Lead

Product Highlights
n Optim lead insulation – a chemical co-polymer that blends the best features of
polyurethane and silicone for improved handling and increased durability.
n Thin lead body to provide ease of passage and a small venous space.
n Active mapping collar enables threshold measurements prior to extending the
helix to save time at implant.
n Ventricular straight or atrial J-shaped active-fixation options.
n Short tip-to-ring spacing to reduce the potential for oversensing.

Ordering Information
Contents: Cardiac pacing lead

Model Number Insulation Fixation Min. Introducer (F) Connector Length (cm)
1888TC Optim Ext/Ret Helix 6 IS-1 bipolar 52

Indications and Usage: The Tendril® ST Model 1888 lead is designed for permanent sensing and pacing Adverse Events: Potential complications associated with the use of Tendril® ST leads are the same as
in either the right atrium or the right ventricle, in combination with a compatible device. The Tendril ST with the use of other active fixation leads and include: cardiac tamponade, diaphragmatic stimulation,
Model 1882 is designed for permanent sensing and pacing in the right atrium, in combination with a embolism, excessive bleeding, induced ventricular ectopy, infection, loss of pacing and/or sensing due
compatible device. Active leads such as the Tendril ST Models 1888 and 1882 leads may be indicated for to dislodgment or mechanical malfunction of the pacing lead, phrenic nerve stimulation, thrombosis.
patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax,
use of screw-in leads such as Tendril ST Models 1888 or 1882 leads may be indicated in the presence of laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation
an abnormal, surgically altered or excised atrial appendage. of other vessels, massive hemorrhage and, rarely, death.
Contraindications: Tendril® ST Model 1888 and 1882 leads are contraindicated: in the presence of Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
tricuspid atresia, for patients with mechanical tricuspid valves, in patients who are expected to be adverse events.
hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Tendril® ST Optim™
Pacing Lead

Product Specifications
PHYSICAL SPECIFICATIONS
Model 1888TC
Conductor MP35N ®* coil
Length 52 cm
Lead Connector IS-1 bipolar
Minimum Introducer Size 6 F
Type of Lead Transvenous, screw-in, bipolar, steroid
Fixation Mechanism Extendable/retractable helix
Shape Straight
Tip-to-Ring Spacing 10 mm
Lead Tip Electrode (Cathode) Pt/Ir collar + active titanium nitride coated Pt/Ir helix
(2 mm extension)
Tip Electrode Surface Area 8.5 mm2
Ring Electrode (Anode) Titanium nitride coated Pt/Ir ring
Ring Electrode Surface Area 16 mm2
Mapping Available with collar
Steroid Elution Yes
Insulation Optim

* MP35N is a trademark of SPS Technologies, LLC.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Tendril® STS
Pacing Lead

Product Highlights
n Soft silicone tip offers more compliance and less tip pressure at the lead tip-
endocardium interface.
n Small diameter lead offers improved ease of venous passage, reduced risk of
venous thrombosis or rib-clavicle crush and ability to accommodate additional
leads more easily.
n Optim® lead insulation – a chemical co-polymer that blends the best features
of polyurethane and silicone for improved handling and increased durability.
n Titanium nitride (TiN) fractal coating on the tip and ring electrodes is
designed to promote precise sensing and to provide improved contact with the
myocardium.
n Lubricious Fast-Pass® coating facilitates lead insertion through the introducer
and veins to ease implantation.
n Fits through a 6 F introducer.

Ordering Information
Contents: Cardiac pacing lead

Model Number Insulation Fixation Min. Introducer (F) Connector Lengths (cm)
2088TC Optim Ext/Ret Helix 6 IS-1 bipolar 46, 52, 58

Indications: Tendril® STS Lead is designed for permanent sensing and pacing in either the right atrium or Adverse Events: Potential complications associated with the use of Tendril STS lead are the same as
the right ventricle, in combination with a compatible device. Active leads such as the Tendril STS lead may with the use of other active fixation leads and include: cardiac tamponade, diaphragmatic stimulation,
be indicated for patients where permanent fixation of passive leads is suspected to be unstable. embolism, excessive bleeding, induced ventricular ectopy, infection, loss of pacing and/or sensing due
to dislodgment or mechanical malfunction of the pacing lead, phrenic nerve stimulation, thrombosis.
In atrial applications, the use of screw-in leads such as Tendril STS lead may be indicated in the presence Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax,
of an abnormal, surgically altered or excised atrial appendage. laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation
Contraindications: Tendril STS lead is contraindicated: in the presence of tricuspid atresia, for patients of other vessels, massive hemorrhage and, rarely, death.
with mechanical tricuspid valves, in patients who are expected to be hypersensitive to a single dose of one Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
milligram of dexamethasone sodium phosphate.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
adverse events.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Tendril® STS
Pacing Lead

Product Specifications
PHYSICAL SPECIFICATIONS
Model 2088TC
Minimum Introducer Size 6F
Type of Lead Active-fixation, bipolar, steroid-eluting, endocardial, pacing lead
Lead Connector IS-1 bipolar
Lead Lengths 46, 52 and 58 cm
Fixation Mechanism Extendable/Retractable helix
Typical Number of Rotations
for Helix Extension 6-11 (straight stylet)
Lead Body Diameter 1.9 mm (max)
Tip-to-Ring Spacing 10 mm
Lead Tip Electrode (Cathode) Active TiN-coated Pt/Ir helix (2.0 mm extension)
Tip Electrode Surface Area 6.9 mm2
Ring Electrode (Anode) TiN-coated Pt/Ir
Ring Electrode Surface Area 16 mm2
Mapping Capable with TiN-coated Pt/Ir helix
Steroid < 1 mg dexamethasone sodium phosphate
Inner Conductor/Outer Conductor MP35N* coil
Inner Insulation Silicone rubber
Outer Insulation Optim lead insulation
Lead Body Coating Fast-Pass® coatingP

In Pack

Straight stylets 1 x-soft in lead, 1 x-soft, 1 soft

J-curved stylets 2 soft
Helix extension/retraction clip-on tools 2 clip-on tools

Accessory Kits
Available Separately Model Number Compatible Lengths Description

Stylet Kit DSO6002 with appropriate 46, 52 and 58 cm 1 fixation tool, 1 clip-on tool,
length designation 1 J-shaped soft, 1 x-soft,
1 soft, 1 firm, 1 x-firm
DSO6003 with appropriate 46, 52 and 58 cm 1 clip-on tool, 1 J-shaped soft,
length designation 1 x-soft, 1 soft, 1 firm, 1 x-firm

Locator ® Plus 1281 with appropriate 46, 52 and 58 cm Disposable implant tool that
Deflectable Stylet length designation facilitates precise lead
positioning
1292 with appropriate 46, 52 and 58 cm and allows manipulation with
length designation one hand

* MP35N is a registered trademark of SPS Technologies, Inc.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Merlin®
Pacing System Analyzer (PSA)

Product Highlights
n Provides confidence and control at implant by quickly delivering accurate
measurements for optimal lead positioning and a streamlined implant.
n Connects directly to the Merlin® Patient Care System, delivering a seamless,
intuitive interface.
n Fast parameter programming and switching speed.
n Able to display on external monitors.
n Independent atrial, right ventricular and left ventricular channels.
n Continuously displayed measurements on a beat-by-beat basis.
n Dedicated current of injury display.

Ordering Information
Model Number Part Number Description
EX3100 100002300 Merlin Pacing System Analyzer

Merlin PSA accessories

Model Number Part Number Description

EX3160 100031916 Merlin storable pouch

EX3170 100015290 For use with Medtronic-style disposable cables

(Models 4051 and 4061)
EX3180 100015301 For use with Medtronic 2292 re-sterilizable cable
EX3190 100019848 USB to RF antenna
4051 1020752-001 Disposable Threshold Cable (Medtronic connector)
4053A 5070142-101 Non-Disposable Adapter (to threshold cable Medtronic
connector)
4160 60010198-001 Disposable Threshold cable for DF4 leads
(Biotronik connector)
4161 60010086-001 Disposable Threshold cable for DF4 leads
(Medtronic connector)
PK-67-S 5030162-001 Non-Disposable Adapter (to threshold cable Biotronik
connector)

Intended Use: The Merlin® PSA is intended to assess the pacing and sensing performance of the lead The Merlin PSA is not intended for use as a temporary pacemaker or for life sustaining pacing support.
system prior to pulse generator implantation, or during invasive lead system troubleshooting. The Merlin PSA is not intended for diagnostic purposes.

Only use the Merlin PSA with the Merlin PCS. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Contraindications: There are no known contraindications to the use of a lead-analysis device. The Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
patient’s age and medical condition, however, may dictate the pacing modes and lead assessment adverse events.
activities appropriate for the patient.

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

Merlin®
Patient Care System (PCS)

Product Highlights
n 15” touch screen clearly displays programming and diagnostic screens.
n New user interface allows for faster patient management.
n Continuous, simultaneous display of surface ECGs, intracardiac electrograms
(EGMs), and annotated event markers allows quick interpretation.
n Built-in top-load/top-exit printer quickly and quietly prints full-page (8 inch)
reports for patient charts.
n Integrated cable storage speeds setup and saves space with always-
connected cables and ample storage space.

Ordering Information

Model Number Part Number Description

3650 Merlin Patient Care System (PSA)

Merlin (PCS) Accessories

Model Number Part Number Description

EX3000 60018372 3-Lead ECG Patient Cable
3134 60000909-001 VGA Cable and Adapter (female to male) (25’ length)

3615 60004294-001 Adapter for 3150 PSA Wand (required for use of
PSA Wand Model 3150 with the Merlin Patient Care System)
3616 60005260-001 Wand Extension Cable (4’ length)
3617 60005251-001 External ECG Input Cable (25’ length)
3618-US 60005252-002 External Keyboard (U.S. configuration)
3620 60005254-001 External Floppy Disk Drive
EX3621-2GB 100006806 Flash Drive (2 GB)
3622 60005256-001 Shoulder Strap
3623 60005257-001 USB to RS232 Serial Adapter (for direct Paceart® connection)
3625 60003676-001 5 Electrode ECG Cable – Standard U.S.
3630 60002876-001 Merlin Patient Care System Telemetry Wand (with Magnet)
3630M 60002876-097 Magnet
3638 50019403-001 Antenna (required to enable radio frequency [RF] communication
between Merlin PCS and St. Jude Medical® implantable devices
with RF communication capability)
3643 60003605-001 Thermal Paper

U.S. Customer Support: 1-800-722-3774

Outside U.S. Customer Support: 46-8-474-4147

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE
ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted,
® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical,
Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
©2010 St. Jude Medical, Inc. All rights reserved. Page PEE2
Global Headquarters Cardiac Rhythm International Division
One Lillehei Plaza Management Division One Lillehei Plaza
St. Paul, Minnesota 55117 15900 Valley View Court St. Paul, Minnesota 55117
USA Sylmar, California 91342 USA
+1 651 483 2000 USA +1 651 483 2000
+1 651 490 4310 Fax +1 818 362 6822 +1 651 481 7741 Fax
+1 818 364 5814 Fax

SJMprofessional.com

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