AZURE™ S DR

MRI SURESCAN™
Model W3DR01

Physical characteristics
Physical characteristics
Volumea 12.75 cm3
Mass 22.5 g
HxWxD b
46.6 mm x 50.8 mm x 7.4 mm
Radiopaque IDc RNA
Surface area of
33.48 cm2
titanium device can
Materials in contact with Titanium, polyurethane,
human tissued silicone rubber

Battery
Lithium-hybrid CFx silver § BlueSync™ ready
vanadium oxide
a
b
 olume with connector holes unplugged.
V
Grommets may protrude slightly beyond the can surface.
§ Over 10 years longevitya
c
The radiopaque ID, which includes a Medtronic-identifier symbol, can be viewed in a
d
fluoroscopic image of the device.
These materials have been successfully tested for the ability to avoid biological
§ Updated MVP™ algorithm
incompatibility. The device does not produce an injurious temperature in the
surrounding tissue during normal operation. § Approved for 1.5T and 3T MRI usea
a
 anual reference: Medtronic Azure S DR MRI SureScan W3DR01 Device Manual.
M
Replacement indicators M96355A001 B. Accessed September 13, 2017.

Recommended ≤ 2.63 V on 3 consecutive daily

Replacement Time (RRT) automatic measurements
Elective Replacement
3 months after RRT
Indicator (ERI)
End of Service (EOS) 3 months after ERI

Pacing parameters
Modes, rates, and intervals
Parameter Programmable values
DDDR; DDD; AAIR<=>DDDR ;
Mode AAI<=>DDD; DDIR; DDI; AAIR; AAI;
VVIR; VVI; DOO; AOO; VOO; ODO
Mode Switch On ; Off
Lower Rate a
30; 35 … 60 ; 70; 75 … 150 bpm
80; 85 … 130 … 175; 180;
Upper Tracking Rate
190 … 210 bpm
Paced AV 30; 40 … 180 … 350 ms
Sensed AV 30; 40 … 150 … 350 ms
Maximum AV Interval Limit Off ; 250; 260 … 500
PVARP Auto ; 150; 160 … 500 ms
Minimum PVARP 150; 160 … 250 … 500 ms
A. Refractory Period 150; 160 … 310 … 500 ms
a
 he corresponding Lower Rate Interval can be calculated as follows:
T
Lower Rate Interval (ms) = 60,000/Lower Rate.
 Atrial parameters Blanking periods
Parameter Programmable values Parameter Programmable values
Atrial Amplitude 0.5; 0.75 … 3.5 … 5; 5.5; 6; 8 V a
10a; 20 … 100; 110;
PVAB Interval
0.03; 0.06; 0.1; 0.2; 0.3; 0.4 120 …150 … 300 ms
Atrial Pulse Width
… 1.5 ms PVAB Method Partial ; Partial+; Absolute
Off; 0.15; 0.3; 0.45; 0.6; 0.9; A. Blank Post AP 150; 160 … 200 … 250 ms
1.2; 1.5; 1.8; 2.1; 4.0 mV A. Blank Post AS 100 ; 110 … 170 ms
Atrial Sensitivityb
Unipolar: 0.45 mV
Bipolar: 0.3 mV V. Blank Post VP 150; 160 … 200 … 320 ms
Atrial Pace Polarity Bipolar; Unipolar 120 ; 130 … 170; 200; 220;
V. Blank Post VS
250; 280; 300; 320 ms
Atrial Sense Polarity Bipolar; Unipolar If the PVAB Method is set to Partial, the minimum selectable value for the PVAB
a 

Atrial Lead Monitor Monitor Only; Adaptive Interval is 100 ms.

Min Limit 200 ; 300; 400; 500 Ω Rate response pacing parameters
Max Limit 1,000; 1,500; 2,000; 3,000 Ω
Parameter Programmable values
a 
When Atrial Amplitude is 8 V, Atrial Pulse Width must be less than 1.3 ms.
b
This setting applies to all sensing in this chamber for both tachyarrhythmia detection Upper Sensor Rate 80; 85 … 130 … 175 bpm
and bradycardia pacing operations.
ADL Rate 60; 65 … 95 … 170 bpm
RV parameters Rate Profile Optimization On ; Off
Parameter Programmable values ADL Response 1; 2; 3 ; 4; 5
RV Amplitude 0.5; 0.75 … 3.5 … 5; 5.5; 6; 8 V a
Exertion Response 1; 2; 3 ; 4; 5
0.03; 0.06; 0.1; 0.2; 0.3; 0.4 Low ; Medium Low;
RV Pulse Width Activity Threshold
… 1.5 ms Medium High; High
0.45; 0.60; 0.90 ; 1.20; 2.00; Activity Acceleration 15; 30 ; 60 s
2.80; 4.00; 5.60; 8.00; 11.30 mV Activity Deceleration Exercise ; 2.5; 5; 10 min
RV Sensitivity b
Unipolar: 2.80 mV
Bipolar: 0.90 mV ADL Set Point 5; 6 … 40; 42 … 80
RV Pace Polarity Bipolar; Unipolar UR Set Point 15; 16 … 40; 42 … 80; 85 … 180
RV Sense Polarity Bipolar; Unipolar
Rate Adaptive AV parameters
RV Lead Monitor Monitor Only; Adaptive
Parameter Programmable values
Min Limit 200 ; 300; 400; 500 Ω
Rate Adaptive AV Off ; On
Max Limit 1,000; 1,500; 2,000; 3,000 Ω
a
 hen RV Amplitude is 8 V, RV Pulse Width must be less than 1.3 ms.
W Start Rate 50; 55 … 90 … 145 bpm
b
This setting applies to all sensing in this chamber for both tachyarrhythmia detection
and bradycardia pacing operations.
Stop Rate 55; 60 … 130 … 175 bpm
Minimum Paced AV 30; 40 … 140 … 200 ms
Atrial Capture Management™ parameters
Minimum Sensed AV 30; 40 … 110 … 200 ms
Parameter Programmable values
Atrial Capture Management™ Adaptive ; Monitor; Off Atrial preference pacing parameters
Atrial Amplitude Parameter Programmable values
1.5x; 2.0x ; 2.5x; 3.0x
Safety Margin A. Preference Pacing On; Off
Atrial Minimum Adapted Maximum Rate 80; 85 … 100 … 150 bpm
1.0; 1.5 ; 2.0; 2.5; 3.0; 3.5 V
Amplitude
Interval Decrement 30 ; 40; 50 … 100; 150 ms
Atrial Acute Phase Remaining Off; 30; 60; 90; 120 ; 150 days
Search Beats 5; 10; 15; 20 … 25; 50

RV Capture Management™ parameters

Parameter Programmable values
RV Capture Management­ ™
Adaptive ; Monitor; Off
RV Amplitude Safety Margin 1.5x; 2.0x ; 2.5x; 3.0x
RV Minimum Adapted
1.0; 1.5; 2.0 ; 2.5; 3.0; 3.5 V
Amplitude
RV Acute Phase Remaining Off; 30; 60; 90; 120 ; 150 days
 Rate drop response parameters Tachyarrhythmia parameters
Parameter Programmable values
Tachyarrhythmia detection parameters
Rate Drop Responsea On; Off
Parameter Programmable values
Detection Type Drop ; Low Rate; Both
AT/AF Detection Monitor
Drop Detection
AT/AF Interval (Rate) a
150; 160 … 350 … 450 ms
Drop Size 10; 15 … 25 … 50 bpm
VT Monitor Monitor ; Off
Drop Rate 30; 40 … 60 … 100 bpm
VT Monitor Interval (Rate) a
280; 290 … 400 … 500 ms
10; 15; 20; 25; 30 s
Detection Window 0.45; 0.60; 0.90; 1.20; 2.00;
1 ; 1.5; 2; 2.5 min
2.80; 4.00; 5.60; 8.00; 11.30 mV
Low Rate Detection RV Sensitivityb,c
Bipolar: 0.9 mV
Detection Beats 1; 2; 3 beats Unipolar: 2.80 mV
Intervention 0.15; 0.30; 0.45; 0.60; 0.90; 1.20;
Intervention Rate 70; 75 … 100 … 150 bpm Atrial Sensitivityb,d 1.50; 1.80; 2.10; 4.0 mV; Off
Bipolar: 0.3 mV
Intervention Duration 1; 2 … 15 min Unipolar: 0.45 mV
a
When Rate Drop Response is set to On, the lower rate is automatically set to 45 bpm. a
 he measured intervals are truncated to a 10 ms multiple (for example, 457 ms
T
becomes 450 ms). The device uses this truncated interval value when applying the
programmed criteria and calculating interval averages.
Sleep parameters b
This setting applies to all sensing in this chamber for both tachyarrhythmia detection
and bradycardia pacing operations.
Parameter Programmable values c
The device complies with the requirements of ISO 14708-2 when the sensitivity
threshold is programmed to 2.0 mV or higher.
Sleep On; Off d
The device complies with the requirements of ISO 14708-2 when the sensitivity
threshold is programmed to 1.8 mV or higher.
30; 35 … 50 ; 55; 60; 70;
Sleep Rate
75 … 100 bpm
00:00; 00:10 … 22:00 …
Bed Time
23:50
Data collection parameters
00:00; 00:10 … 07:00 … Data collection parameters
Wake Time
23:50
Parameter Programmable values
Non-Competitive atrial pacing (NCAP) parameters Can to Aring; Can to RVring;
Atip to Aring ; Atip to RVring;
Parameter Programmable values EGM 1 Source
Atip to Can; Aring to RVring;
Non-Comp Atrial Pacing On ; Off RVtip to RVring; RVtip to Can
NCAP Interval 200; 250; 300 ; 350; 400 ms ±1; ±2; ±4; ±8 ; ±12; ±16;
EGM 1 Range
±32 mV
MRI SureScan™ parameters Can to RVring; RVtip to
EGM 2 Source
RVring ; RVtip to Can
Parameter Programmable values
±1; ±2; ±4; ±8 ; ±12; ±16;
MRI SureScan ™ On; Off EGM 2 Range
±32 mV
MRI Pacing Mode DOO; AOO; VOO; ODO RVtip to RVring; Can to RVring ;
MRI Pacing Rate 60; 70; 75; 80 … 120 bpm EGM 3 Source Atip to RVring; Atip to Aring;
Can to Aring
Additional pacing features ±1; ±2; ±4; ±8 ; ±12; ±16;
EGM 3 Range
Parameter Programmable values ±32 mV
PMT Intervention On; Off EGM1 and EGM2 ; EGM1 and
Monitored
EGM3; EGM2 and EGM3
PVC Response On ; Off
Off ; On – 1 month;
V. Safety Pacing On ; Off Pre-arrhythmia EGM On – 3 months;
Rate Hysteresis Off ; 30; 40 … 80 bpm On Continuous
Device Date/Timea (select Time Zone)
Off ; 0.5; 1; 2; 4; 8; 16; 24; 36;
Holter Telemetry
46 hr
Wireless Telemetry with
On; Off
Monitor
a
 he times and dates stored in episode records and other data are determined by the
T
Device Date/Time clock.
Medtronic CareAlert™ parameters System test parameters
Clinical management alerts System test parameters
Parameter Programmable values Parameter Selectable values
AT/AF Burden and Rate Settings Pacing Threshold Test parameters
AT/AF Alerts Test Type Amplitude; Pulse Width
AT/AF Daily Burden Enable Off ; On Chamber Atrium; RV
Daily AT/AF Burden 0.5; 1; 2; 6 ; 12; 24 hr/24 hr Decrement after 2; 3 … 15 pulses
Avg. V. Rate During Modea (RV Test) VVI; VOO; DDI; DDD; DOO
Off ; On
AT/AF Enable Modea (Atrium Test) AAI; AOO; DDI; DDD; DOO
Daily Burden for Lower Rate 30; 35 … 60; 70; 75 … 150c bpm
0.5; 1; 2; 6 ; 12; 24 hr/24 hr
Avg. V. Rate (hr/24 hr)
RV Amplitude 0.25; 0.5 … 5; 5.5; 6; 8 V
Avg. V. Rate During AT/AF 90; 100 … 150 bpm
RV Pulse Width 0.03; 0.06; 0.1; 0.2 … 1.5 ms
Monitored VT Episode
Off ; On A. Amplitude 0.25; 0.5 … 5; 5.5; 6; 8 V
Detected
Cumulative Right Ventricular A. Pulse Width 0.03; 0.06; 0.1; 0.2 … 1.5 ms
Off ; Onb
Pacing > 40%a AV Delay b
30; 40 … 350 ms
a
 here is no observation for Cumulative Right Ventricular Pacing > 40%.
T
b
Alert triggered if cumulative percent of right ventricular pacing exceeds 40% for V. Pace Blanking 150; 160 … 320 ms
7 consecutive days.
A. Pace Blanking 150; 160 … 250 ms
PVARP 150; 160 … 500 ms
Lead/Device integrity alerts
Pace Polarity Unipolar; Bipolar
Parameter Programmable values
Sensing Test parameters
Low Battery Voltage RRT On ; Off
Modea AAI; DDD; DDI; VVI; ODO
Lead Impedance Out of Range
AV Delayb 30; 40 … 350 ms
Lead Impedance
Lower Rate c
30; 35 … 60; 70; 75 … 120 bpm
A. Pacing Enable On ; Off a
 he selectable values for this parameter depend on the programmed pacing mode.
T
A. Pacing Less than 200 ; 300; 400; 500 Ω
b
The selectable values for this parameter depend on the programmed Lower Rate.
c
When performing the test in DDD mode, the Lower Rate must be less than the
A. Pacing Greater than 1,000; 1,500; 2,000; 3,000 Ω programmed Upper Tracking Rate.

RV Pacing Enable On ; Off

RV Pacing Less than 200 ; 300; 400; 500 Ω
RV Pacing Greater than 1,000; 1,500; 2,000; 3,000 Ω
Capture Management High Threshold
™

High Threshold
A. Capture Enablea Off ; On
RV Capture Enableb Off ; On
a
I f programmed to On, alert notification is sent if A. capture management™ has
measured high thresholds for 3 consecutive days.
b
If programmed to On, alert notification is sent if RV capture management™ has
measured high thresholds for 3 consecutive days.
Longevity
Projected service life in years
500 Ω 600 Ω 900 Ω
pacing impedance pacing impedance pacing impedance
Pre-arrhythmia
Pacing EGM storagea 2.5 V 3.5 V 2.5 V 3.5 V 2.5 V 3.5 V
Off 15.8 15.8 15.8 15.8 15.8 15.8
DDD, 0%
On 15.7 15.7 15.7 15.7 15.7 15.7
Off 14.6 13.6 14.8 13.9 15.1 14.4
DDD, 15%
On 14.5 13.5 14.7 13.8 15.0 14.3
Off 12.4 10.2 12.8 10.8 13.6 11.9
DDD, 50%
On 12.3 10.1 12.7 10.7 13.5 11.9
AAI<=>DDD (MVP™ Mode) Off 13.7 12.1 14.0 12.6 14.5 13.4
50% Atrial, 5% Ventricular On 13.6 12.1 13.9 12.5 14.4 13.3
Off 10.2 7.5 10.8 8.1 12.0 9.6
DDD, 100%
On 10.1 7.4 10.7 8.1 11.9 9.5
a
 he data provided for programming Pre-arrhythmia EGM storage to On are based on a
T The data are based on pacing outputs programmed to the specified amplitude and 0.4
6-month period (two 3-month follow-up intervals) over the life of the device. Additional ms pulse width and 60 bpm pacing rate. The service life of the device is affected by the
use of Pre-arrhythmia EGM storage reduces projected service life by approximately programmed settings for certain features, such as Pre-arrhythmia EGM storage. Projected
12.1% or 1.4 months per year. service life estimates are based on accelerated battery discharge data and device modeling
as specified. These values should not be interpreted as precise numbers.
Note: These projections are based on typical shelf storage time (5 months). Assuming
worst-case shelf storage time (18 months), longevity is reduced by approximately 7%. Manual reference: Medtronic Azure S DR MRI SureScan W3DR01 Device Manual.
M96355A001 B. Accessed September 13, 2017.
Brief Statement
Azure TM MRI SR and DR IPG
Indications
The Azure DR MRI and Azure SR MRI SureScan TM systems are indicated for the rate of competition between paced and intrinsic rhythms. Single chamber atrial pacing
adaptive pacing in patients who may benefit from increased pacing rates concurrent is contraindicated in patients with an AV conduction disturbance. ATP therapy is
with increases in activity. Accepted patient conditions warranting chronic cardiac contraindicated in patients with an accessory antegrade pathway.
pacing include symptomatic paroxysmal or permanent second- or third-degree AV
block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient Warnings and Precautions: Changes in patient’s disease and/or medications may
sinus node dysfunctions with or without associated AV conduction disorders, or alter the efficacy of the device’s programmed parameters. Patients should avoid
bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms sources of magnetic and electromagnetic radiation to avoid possible underdetection,
of symptomatic tachyarrhythmias. inappropriate sensing and/or therapy delivery, tissue damage, induction of an
arrhythmia, device electrical reset, or device damage. Do not place transthoracic
The Azure DR MRI devices are also indicated for dual chamber and atrial tracking modes defibrillation paddles directly over the device. Use of the device should not change the
in patients who may benefit from maintenance of AV synchrony. Dual chamber modes application of established anticoagulation protocols.
are specifically indicated for treatment of conduction disorders that require restoration
of both rate and AV synchrony, which include various degrees of AV block to maintain Patients and their implanted systems must be screened to meet the following
the atrial contribution to cardiac output, VVI intolerance (for example, pacemaker requirements for MRI: no lead extenders, lead adaptors, or abandoned leads present;
syndrome) in the presence of persistent sinus rhythm, or vasovagal syndromes or no broken leads or leads with intermittent electrical contact as confirmed by lead
hypersensitive carotid sinus syndromes. Antitachycardia pacing (ATP) is indicated for impedance history; the device must be operating within the projected service life, and
termination of atrial tachyarrhythmias in bradycardia patients with one or more of the the system must be implanted in the left or right pectoral region.
above pacing indications. Potential Adverse Events or Potential Complications: Potential complications
MRI Conditions for Use: Medtronic SureScan pacing systems are MR conditional, and include, but are not limited to, rejection phenomena, erosion through the skin, muscle or
as such are designed to allow patients to undergo MRI under the specified conditions nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes,
for use. Pacemaker SureScan system patients may be scanned using a horizontal field, acceleration of tachycardia, and surgical complications such as hematoma, infection,
cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When inflammation, and thrombosis. Potential lead complications include, but are not
programmed to On, the MRI SureScan feature allows the patient to be safely scanned limited to, valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac
while the device continues to provide appropriate pacing. A complete SureScan pacing perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial
system, which is a SureScan device with appropriate SureScan lead(s), is required for irritability, and pneumothorax. Other potential complications related to the lead
use in the MR environment. To verify that components are part of a SureScan system, may include lead dislodgement, lead conductor fracture, insulation failure, threshold
visit http://www.mrisurescan.com/. Any other combination may result in a hazard to the elevation, or exit block. Potential MRI complications include, but are not limited to, lead
patient during an MRI scan. electrode heating and tissue damage resulting in loss of sensing or capture or both, or
induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic
Contraindications: The Azure DR MRI and Azure SR MRI SureScan systems are collapse.
contraindicated for concomitant implantation with another bradycardia device See the device manuals before performing an MRI Scan for detailed information regarding
or with an implantable cardioverter defibrillator. Rate-responsive modes may be the implant procedure, indications, MRI conditions of use, contraindications, warnings,
contraindicated in those patients who cannot tolerate pacing rates above the precautions, and potential complications. For further information, call Medtronic at
programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.
with chronic or persistent supraventricular tachycardias, including atrial fibrillation or
flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) Caution: Federal law (USA) restricts these devices to sale by or on the order of a
physician.

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