AZURE™ S SR

MRI SURESCAN™
Model W3SR01

Physical characteristics
Physical characteristics
Volumea 12.25 cm3
Mass 22.5 g
HxWxD b
42.6 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 13 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
§ Approved for 1.5T and 3T MRI usea
incompatibility. The device does not produce an injurious temperature in the a
 edtronic Azure S SR MRI SureScan W3SR01 Device Manual. M964357A001 B.
M
surrounding tissue during normal operation. Accessed September 13, 2017.

Replacement indicators
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
Mode VVIR ; VVI; VOO; OVO
Lower Rate a
30; 35 … 60 ; 70; 75 … 150 bpm
a
 he corresponding Lower Rate Interval can be calculated as follows:
T
Lower Rate Interval (ms) = 60,000/Lower Rate.
 RV parameters Sleep parameters
Parameter Programmable values Parameter Programmable values
RV Amplitude 0.5; 0.75 … 3.5 … 5; 5.5; 6; 8 V a
Sleep On; Off
0.03; 0.06; 0.1; 0.2; 0.3; 0.4 30; 35 … 50 ; 55; 60; 70;
RV Pulse Width Sleep Rate
… 1.5 ms 75 … 100 bpm
0.45; 0.60; 0.90 ; 1.20; 2.00; 00:00; 00:10 … 22:00 …
Bed Time
2.80; 4.00; 5.60; 8.00; 11.30 mV 23:50
RV Sensitivityb
Unipolar: 2.80 mV 00:00; 00:10 … 07:00 …
Bipolar: 0.90 mV Wake Time
23:50
RV Pace Polarity Bipolar; Unipolar
RV Sense Polarity Bipolar; Unipolar MRI SureScan™ parameters
RV Lead Monitor Monitor Only; Adaptive Parameter Programmable values
Min Limit 200 ; 300; 400; 500 Ω MRI SureScan ™ On; Off
Max Limit 1,000; 1,500; 2,000; 3,000 Ω MRI Pacing Mode VOO; OVO
a
 hen RV Amplitude is 8 V, RV Pulse Width must be less than 1.3 ms.
W
b
This setting applies to all sensing in this chamber for both tachyarrhythmia detection
MRI Pacing Rate 60; 70; 75; 80 … 120 bpm
and bradycardia pacing operations.
Additional pacing features
RV Capture Management™ parameters
Parameter Programmable values
Parameter Programmable values
Rate Hysteresis Off ; 30; 40 … 80 bpm
RV Capture Management­™ Adaptive ; Monitor; Off
RV Amplitude Safety Margin 1.5x; 2.0x ; 2.5x; 3.0x
RV Minimum Adapted
Amplitude
1.0; 1.5; 2.0 ; 2.5; 3.0; 3.5 V Tachyarrhythmia parameters
RV Acute Phase Remaining Off; 30; 60; 90; 120 ; 150 days Tachyarrhythmia detection parameters
Parameter Programmable values
Blanking periods
VT Monitor Monitor ; Off
Parameter Programmable values
VT Monitor Interval (Rate) a
280; 290 … 360 … 500 ms
V. Blank Post VP 150; 160 … 200 … 320 ms
0.45; 0.60; 0.90; 1.20; 2.00;
120 ; 130 … 170; 200; 220; 2.80; 4.00; 5.60; 8.00; 11.30 mV
V. Blank Post VS RV Sensitivity b,c
250; 280; 300; 320 ms Bipolar: 0.9 mV
Unipolar: 2.80 mV
Rate response pacing parameters 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
Parameter Programmable values programmed criteria and calculating interval averages.
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.
c
The device complies with the requirements of ISO 14708-2 when the sensitivity
ADL Rate 60; 65 … 95 … 170 bpm threshold is programmed to 2.0 mV or higher.

Rate Profile Optimization On ; Off

ADL Response 1; 2; 3 ; 4; 5
Exertion Response 1; 2; 3 ; 4; 5
Low ; Medium Low;
Activity Threshold
Medium High; High
Activity Acceleration 15; 30 ; 60 s
Activity Deceleration Exercise ; 2.5; 5; 10 min
ADL Set Point 5; 6 … 40; 42 … 80
UR Set Point 15; 16 … 40; 42 … 80; 85 … 180
Data collection parameters System test parameters
Data collection parameters System test parameters
Parameter Programmable values Parameter Selectable values
Can to RVring; RVtip to Pacing Threshold Test parameters
EGM 1 Source
RVring ; RVtip to Can Test Type Amplitude; Pulse Width
±1; ±2; ±4; ±8 ; ±12; ±16; Chamber RV
EGM 1 Range
±32 mV
Decrement after 2; 3 … 15 pulses
Can to RVring; RVtip to
EGM 2 Source RV Pace Polarity Unipolar; Bipolar
RVring; RVtip to Can
±1; ±2; ±4; ±8 ; ±12; ±16; Mode a
VVI; VOO
EGM 2 Range
±32 mV Lower Rate 30; 35 … 60; 70; 75 … 150 bpm
RVtip to RVring; Can to RVring ; RV Amplitude 0.25; 0.5 … 5; 5.5; 6; 8 V
EGM 3 Source
RVtip to Can
RV Pulse Width 0.03; 0.06; 0.1; 0.2 … 1.5 ms
±1; ±2; ±4; ±8 ; ±12; ±16;
EGM 3 Range V. Pace Blanking 150; 160 … 320 ms
±32 mV
Sensing Test parameters
EGM1 and EGM2 ; EGM1 and
Monitored Modea VVI; OVO
EGM3; EGM2 and EGM3
Off ; On – 1 month; Lower Rate 30; 35 … 60; 70; 75 … 120 bpm
Pre-arrhythmia EGM On – 3 months; a
The selectable values for this parameter depend on the programmed pacing mode.
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

Clinical management alerts
Parameter Programmable values
Monitored VT Episode
Off ; On
Detected
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
7 consecutive days.

Lead/Device integrity alerts

Parameter Programmable values
Low Battery Voltage RRT On ; Off
Lead Impedance Out of Range
Lead Impedance
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
RV Capture Enablea Off ; On
a
I f 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 18.3 18.3 18.3 18.3 18.3 18.3
VVI, 0%
On 18.2 18.2 18.2 18.2 18.2 18.2
Off 17.5 16.7 17.6 16.9 17.8 17.3
VVI, 15%
On 17.4 16.6 17.5 16.8 17.7 17.2
Off 15.8 13.9 16.1 14.4 16.7 15.4
VVI, 50%
On 15.7 13.8 16.0 14.3 16.6 15.3
Off 13.9 11.2 14.4 11.9 15.4 13.3
VVI, 100%
On 13.8 11.1 14.3 11.8 15.3 13.2
a
 he data provided for programming Pre-arrhythmia EGM storage to On are based on a 6-month period (two 3-month follow-up intervals) over the life of the device. Additional use of
T
Pre-arrhythmia EGM storage reduces projected service life by approximately 13.6% or 1.6 months per year.
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%.
The data are based on pacing outputs programmed to the specified amplitude and 0.4 ms pulse width and 60 bpm pacing rate. The service life of the device is affected by the
programmed settings for certain features, such as Pre-arrhythmia EGM storage. Projected 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: Medtronic Azure S SR MRI SureScan W3SR01 Device Manual. M96435A001 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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