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Medtronic
Medtronic Crome HF CRT-D MRI SureScan DTPC2D4: Product Specifications and Features
Technical Specification for Medtronic models including: Medtronic, Crome, HF CRT-D, MRI SureScan, DTPC2D4, ICD, CRT-D, cardiac rhythm management, pacing, defibrillation, MRI conditional, SureScan system
Crome HF CRT-D DF-4 Spec Sheet Download the spec sheet to learn more about Crome HF CRT-D DF-4 model. ICD & CRT-D Systems - Crome | Medtronic
product-spec-sheet-crome-hf-crt-d-mri-surescan-dtpc2d4 ?bypassIM=true CromeTM HF CRT-D MRI SureScanTM
Model DTPC2D4
Product specifications
Physical characteristics
Volumea
35 cm3
Mass
82.1 g
H x W x D
73 mm x 51 mm x 13 mm
Surface area of device can 57 cm2
Radiopaque IDb
PLS
Materials in contact with human tissuec
Titanium, polyurethane, silicone rubber, titanium dioxide
Battery
Hybrid CFx lithium/silver vanadium oxide
a Volume with connector ports unplugged. b The radiopaque ID, which includes a Medtronic identifier symbol, can be viewed in a fluoroscopic image of the device. c These materials have been successfully tested for the ability to avoid biological incompatibility. The device does not produce an injurious temperature in the surrounding tissue during normal operation.
Replacement indicators
Recommended Replacement Time (RRT)
End of Service (EOS)
< 2.80 V on 3 consecutive daily automatic measurements
3 months after RRT
Maximum energy levels and typical full energy charge times
Maximum programmed energy
40 J
Maximum delivered energya 40 J
Maximum stored energyb 47 J
Typical charge time
between Beginning of Service (BOS)c and
Recommended Replacement Time (RRT)c
10.5 s
a Energy delivered at connector block into a 50 load. b Energy stored at charge end on capacitor. c Charge time during a nonwireless telemetry session may be slightly higher.
§ BlueSyncTM Technology § Reactive ATPTM Algorithm § SmartShockTM 2.0 Technology § 1.5T and 3T MRI Access* § PhysioCurveTM Design § OptiVolTM 2.0 Fluid Status Monitoring § DF4
*When MR conditions for use are met.
Device parameters
Tachyarrhythmia detection parameters
Parameter
Programmable values
AT/AF Detection
On; Monitor
Zones
1 ;2
AT/AF Atrial Intervala
150 (400); 160 (375) ... 350 (171) ... 450 (133) ms (bpm)
FAST AT/AF Atrial Intervala
150 (400); 160 (375) ... 200 (300) ... 250 (240) ms (bpm)
VF Detectionb
On ; Off
VF Detection Intervala
240 (250); 250 (240) ... 320 (188) ... 400 (150) ms (bpm)
VF Initial Beats to Detect
12/16; 18/24; 24/32; 30/40 ; 45/60; 60/80; 75/100; 90/120; 105/140; 120/160
VF Beats to Redetect
6/8; 9/12; 12/16 ; 18/24; 21/28; 24/32; 27/36; 30/40
FVT Enable
Off ; via VF; via VT
FVT Detection Intervala
200 (300); 210 (286) ... 240 (250) ... 600 (100) ms (bpm)
VT Detection
On; Off
VT Detection Intervala
280 (214); 290 (207) ... 360 (167) ... 650 (92) ms (bpm)
VT Initial Beats to Detect 12; 16 ... 52; 76; 100
VT Beats to Redetect
8; 12 ... 52
Monitor
Monitor ; Off
VT Monitor Intervala
280 (214); 290 (207) ... 450 (133) ... 650 (92) ms (bpm)
Monitored VT Beats to Detect
16; 20 ... 32 ... 56; 80; 110; 130
PR LogicTM/Wavelet
AF/Aflb
On ; Off
Sinus Tachb
On ; Off
Other 1:1 SVTs
On; Off
Waveletb Template Collected Template Evaluated
On ; Off; Monitor [date]c [date]c
Match Threshold
40; 43 ... 70 ... 97%
Auto Collection SVT V. Limita
Off; On 240; 250; 260 ... 650 ms
Other enhancements Stabilitya
Off ; 30; 40 ... 100 ms
Onset
Off ; On; Monitor
Percent
72; 75; 78; 81 ; 84; 88; 91; 94; 97%
High Rate Timeout
VF Zone Only
Off ; 0.25; 0.5; 0.75; 1; 1.25; 1.5; 1.75; 2; 2.5; 3; 3.5; 4; 4.5; 5 min
All Zones
Off ; 0.5; 1; 1.5 ... 5; 6; 7 ... 20; 22; 24; 26; 28; 30 min
T-Wave
On ; Off
RV Lead Noise
On ; Off; On+Timeout
Timeout
0.25; 0.5; 0.75 ... 2 min
a The measured intervals are truncated to a 10 ms multiple (for example, 457 ms becomes 450 ms). The device uses this truncated interval value when applying the programmed criteria and calculating interval averages. b The Wavelet feature is automatically set to On when VF Detection is set to On. c Date is auto-generated.
Atrial tachyarrhythmia detection parameters
Parameter
Programmable values
AT/AF Pacing Therapies
AT/AF Rx Status
On; Off
Therapy Type
Rx1: Ramp ; Burst+; 50 Hz Rx2: Ramp; Burst+ ; 50 Hz Rx3: Ramp ; Burst+; 50 Hz
Fast AT/AF Pacing Therapies
Fast AT/AF Rx Status
On; Off
Therapy Type
Rx1: Ramp ; Burst+; 50 Hz Rx2: Ramp; Burst+ ; 50 Hz Rx3: Ramp ; Burst+; 50 Hz
AT/AF Automatic CV
Automatic CV Status Therapy Type
On; Off CVa; Rx4: CV; Rx5: CV
Energy Pathwayb
0.4; 0.6 ... 1.8; 2; 3 ... 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35; 40 J
AX>B; B>AX
Fast AT/AF Automatic CV
Automatic CV Status Therapy Type
On; Off CV a; Rx4: CV; Rx5: CV
Energy Pathwayb
0.4; 0.6 ... 1.8; 2; 3 ... 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35; 40 J
AX>B; B>AX
Shared CV
Minimum R-R Intervalc
400 (150); 410 (146) ... 600 (100) ms (bpm)
Active Can/SVC Coild
Can+SVC On ; Can Off; SVC Off
Automatic CV Limits
Start Time
00:00; 01:00; 02:00; 03:00 ... 23:00
Delivery Window Duration
1 ; 2; 3; 4; 6; 8; 10; 12; 16; 20; 24 h
Maximum shocks per day 1 ; 2; 3; 4; 5; No Limit
Episode Duration before Rx
Episode Duration Before CV
0; 1; 2; 3; 4; 5; 7; 10; 15; 20; 25; 30; 40; 50 min; 1; 2; 3; 4; 5; 6 ; 12; 24; 48; 72 h; 7 d
Atrial tachyarrhythmia detection parameters, cont'd.
Parameter
Programmable values
50 Hz parameters
50 Hz Burst Duration
0.5; 1 ; 2; 3 s
# Sequences
1; 2 ... 10
Burst+ parameters
Initial #S1 Pulses
1; 2 ... 11 ; 12; 13; 14; 15; 20; 25
A-S1 Interval (%AA)
28; 31; 34; 38; 41 ... 59; 63; 66 ... 84 ; 88; 91; 94; 97%
S1-S2 (%AA)
Off; 28; 31; 34; 38; 41 ... 59; 63; 66; 69 ... 81 ; 84; 88; 91; 94; 97%
S2-S3 Decrement
Off; 0; 10; 20 ... 80 ms
Interval Decrement
0; 10 ... 40 ms
# Sequences
1; 2 ... 10
Ramp parameters
Initial #S1 Pulses
1; 2 ... 13 ; 14; 15; 20; 25
A-S1 Interval (%AA)
Rx1-Rx2: 28; 31; 34; 38; 41 ... 59; 63; 66 ... 84; 88; 91 ; 94; 97% Rx3: 28; 31; 34; 38; 41 ... 59; 63; 66 ... 81 ; 84; 88; 94; 97%
Interval Decrement
0; 10 ... 40 ms
# Sequences
1; 2 ... 10
Stop Atrial Rx after (shared)
Rx/Lead Suspect
Disable Atrial ATP if it accelerates V. rate?
Yes ; No
Disable all atrial therapies if atrial lead position is suspect? (Atrial Lead Position Check)
Yes ; No
Duration to Stop
None; 12; 24; 48 ; 72 h
Episode Duration before Rx
0; 1 ; 2; 3; 4; 5; 7; 10; 15; 20; Episode Duration before ATP 25; 30; 40; 50 min;
1; 2; 3; 4; 5; 6; 12; 24 h
Reactive ATP
Rhythm Change
On ; Off
Time Interval
Off ; 2; 4; 7; 12; 24; 36; 48 h
Shared Atrial ATP
A-A Minimum ATP Intervalc 100; 110 ...150 ... 400 ms
A. Pacing Amplitude
1; 2; 3 ... 6 ; 8 V
A. Pacing Pulse Width
0.1; 0.2 ... 1.5 ms
VVI/VOO Backup Pacinge
Off; On (Always); On (Auto Enable)
VVI/VOO Backup Pacing Rate 60; 70 ... 120 bpm
a Nonprogrammable. b If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not used as part of the high-voltage delivery pathway. If the Active Can/SVC Coil parameter is set to SVC Off, the SVC Coil electrode is not used as part of the highvoltage delivery pathway.
c The measured intervals are truncated to a 10 ms multiple (for example, 457 ms becomes 450 ms). The device uses this truncated interval value when applying the programmed criteria and calculating interval averages. d The Active Can/SVC Coil parameter applies to all automatic, manual, and emergency high-voltage therapies. It also applies to T-Shock inductions. e If V. Pacing is programmed to LV, V. Backup Pacing is delivered to the LV chamber. Otherwise, V. Backup Pacing is delivered to the RV chamber.
Ventricular tachyarrhythmia therapy parameters
Parameter
Programmable values
VF Therapies
VF Therapy Status
On ; Off
Energy
Rx1-Rx2: 0.4; 0.6 ... 1.8; 2; 3 ... 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35; 40 J Rx3-Rx6: 10; 11 ... 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35; 40 J
Pathwaya
AX>B; B>AX Rx1-Rx4: B>AX Rx5-Rx6: AX>B
VF ATP
Therapy Status
On ; Off
Therapy Type
Ramp; Burst ; Ramp+
Deliver ATP if last 8 R-R 200; 210 ... 240 ... 300 ms
# Sequences Before Charging
Ramp, Burst, Ramp+: 0 ; 1
# Sequences During Charging
1
Initial # Pulses
Ramp: 1; 2 ... 6 ... 15 Burst: 1; 2 ... 8 ... 15 Ramp+: 1; 2; 3 ... 15
R-S1 Interval = (%RR)
Ramp: 50; 53; 56; 59; 63; 66 ... 84; 88; 91 ; 94; 97% Burst: 50; 53; 56; 59; 63; 66 ... 84; 88 ; 91; 94; 97% Ramp+: 50; 53; 56; 59; 63; 66; 69; 72; 75 ; 78; 81; 84; 88; 91; 94; 97%
Interval Dec
Ramp, Burst: 0; 10 ... 40 ms
ChargeSaver Smart Modeb
On ; Off On ; Off
S1S2 (Ramp+) = (%RR)
50; 53; 56; 59; 63; 66; 69 ... 81; 84; 88; 91; 94; 97%
S2SN (Ramp+) = (%RR)
50; 53; 56; 59; 63; 66 ; 69 ... 81; 84; 88; 91; 94; 97%
FVT Therapies/VT Therapies
FVT Therapy Status
On; Off
VT Therapy Status Therapy Typed,e
On; Off CV; Burst; Ramp; Ramp+
Smart Mode
Rx1-Rx4: On; Off
# Sequences
Burst, Ramp, Ramp+: VT therapies: 1; 2; 3 ... 10 FVT therapies: 1 ; 2 ... 10
Initial # Pulses
Ramp: 1; 2 ... 6 ... 15 Burst: 1; 2 ... 8 ... 15 Ramp+: 1; 2; 3 ... 15
Ventricular tachyarrhythmia therapy parameters, cont'd.
Parameter
Programmable values
R-S1 Interval = (%RR)
Burst: 50; 53; 56; 59; 63; 66 ... 84; 88 ; 91; 94; 97% Ramp: 50; 53; 56; 59; 63; 66 ... 84; 88; 91 ; 94; 97% Ramp+: 50; 53; 56; 59; 63; 66; 69; 72; 75 ; 78; 81; 84; 88; 91; 94; 97%
S1S2 (Ramp+) = (%RR)
50; 53; 56; 59; 63; 66; 69 ... 81; 84; 88; 91; 94; 97%
S2SN (Ramp+) = (%RR)
50; 53; 56; 59; 63; 66 ; 69 ... 81; 84; 88; 91; 94; 97%
Interval Dec
Burst, Ramp: 0; 10 ... 40 ms
CV for FVT and VT therapies
Energy
0.4; 0.6 ... 1.8; 2; 3 ... 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35; 40 J VT Rx1-Rx2: 20 J VT Rx3-Rx6: 40 J FVT Rx1-Rx6: 40 J
Pathwaya
AX>B; B>AX Rx1-Rx4: B>AX Rx5-Rx6: AX>B
Shared V. ATP
V-V Minimum ATP Interval 150; 160 ... 200 ... 400 ms
V. Amplitude
1; 2; 3 ... 6; 8 V
V. Pulse Width
0.1; 0.2 ... 1.5 ms
V. Pace Blanking
170 ; 180; 190 ... 450 ms
V. Pacinge
RV ; LV RV; LV
Shared V. Therapies
Active Can/SVC Coilf
Can+SVC On ; Can Off; SVC Off
Progressive Episode Therapies
On; Off
Confirmation+
On ; Off
a If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not used as part of the high-voltage delivery pathway. If the Active Can/SVC Coil parameter is set to SVC Off, the SVC Coil electrode is not used as part of the highvoltage delivery pathway. b Smart Mode is available for Rx1-Rx4. c FVT therapies must be increasingly aggressive. d Last therapy that is programmed to On must be a CV. e If RV+LV is selected, the ATP therapy is delivered LVRV with a 2.5 ms delay. f The Active Can/SVC Coil parameter applies to all automatic, manual, and emergency high-voltage therapies. It also applies to T-Shock inductions.
Pacing parameters
Modes, rates, and intervals
Parameter
Programmable values
Mode
DDDR; DDD ; AAIR<=>DDDR; AAI<=>DDD; DDIR; DDI; AAIR; AAI; VVIR; VVI; DOO; AOO; VOO; ODO
Mode Switch
On ; Off
Lower Ratea
30; 35 ... 50 ; 55; 60; 70; 75 ... 150 bpm
Upper Tracking Rate
80; 85 ... 130 ... 175 bpm
Paced AV
30; 40 ... 130 ... 350 ms
Sensed AV
30; 40 ... 100 ... 350 ms
PVARP
Auto ; 150; 160 ... 500 ms
Minimum PVARP
150; 160 ... 250 ... 500 ms
A. Refractory Period
150; 160 ... 310 ... 500 ms
a The corresponding Lower Rate Interval can be calculated as follows: Lower Rate Interval (ms) = 60,000/Lower Rate.
Atrial pacing parameters
Parameter
Programmable values
A. Amplitude
0.50; 0.75 ... 1.25; 1.50; 1.75 ... 3.50 ... 5.00; 5.50; 6.00; 8.00 V
A. Pulse Width
0.03; 0.06; 0.10; 0.20; 0.30; 0.40 ... 1.50 ms
Atrial Sensitivitya
Off; 0.15; 0.30 ; 0.45; 0.60; 0.90; 1.20; 1.50; 1.80; 2.10; 4.00 mV
a This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing operations.
RV pacing parameters
Parameter
Programmable values
RV Amplitude
0.50; 0.75 ... 1.25; 1.50; 1.75 ... 3.50 ... 5.00; 5.50; 6.00; 8.00 V
RV Pulse Width
0.03; 0.06; 0.10; 0.20; 0.30; 0.40 ... 1.50 ms
RV Sensitivitya
0.15; 0.30 ; 0.45; 0.60; 0.90; 1.20 mV
Pace Polarity
Bipolar; Tip to Coil
Sense Polarity
Bipolar; Tip to Coil
a This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing operations.
LV parameters Parameter LV Amplitude
LV Pulse Width LV Pace Polarity
Programmable values
0.50; 0.75 ... 1.25; 1.50; 1.75 ... 3.50 ... 5.00; 5.50; 6.00; 8.00 V
0.03; 0.06; 0.10; 0.20; 0.30; 0.40 ... 1.50 ms
LVtip to RVcoil; LVring to RVcoil; LVtip to LVring; LVring to LVtip
CRT parameters Parameter V. Pacing V-V Pace Delay V. Sense Response Maximum Rate Atrial Tracking Recovery
Programmable values RV; LV; RVLV; LVRV 0 ; 10 ... 80 ms On ; Off 95; 100 ... 130 ... 150 bpm On ; Off
Atrial Capture ManagementTM parameters
Parameter
Programmable values
Atrial Capture Management Adaptive ;Off; Monitor
Atrial Amplitude Safety Margin
1.5x ; 2.0x; 2.5x; 3.0x
Atrial Minimum Adapted Amplitude
1.0; 1.5 ; 2.0; 2.5; 3.0; 3.5 V
Atrial Acute Phase Remaining Off; 30; 60; 90; 120 ; 150 days
RV Capture Management parameters
Parameter
Programmable values
RV Capture Management Adaptive ;Off; Monitor
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
RV Acute Phase Remaining Off; 30; 60; 90; 120 ; 150 days
LV Capture Management parameters
Parameter
Programmable values
LV Capture Management LV Amplitude Safety Margin
Adaptive ; Off; Monitor
+ 0.5; + 1.0; + 1.5; + 2.0; + 2.5 V; + Auto
LV Maximum Adapted Amplitude
0.50; 0.75 ... 5.00; 5.50; 6.00 V
Blanking periods
Parameter PVAB Interval PVAB Method
Programmable values
10; 20 ... 150 ... 300 msa 100; 110 ... 150 ... 300 msb
Partial ; Partial+; Absolutec
A. Blank Post AP
150; 160 ... 200 ... 250 ms
A. Blank Post AS
100 ; 110 ... 170 ms
V. Blank Post VP
170; 180 ... 200 ... 450 ms
V. Blank Post VS
120 ; 130 ... 170 ms
a When PVAB Method = Partial+ or Absolute. b When PVAB Method = Partial. c Programming the PVAB method to Absolute automatically resets the interval to 30 ms. If the PVAB method is programmed to Partial or Partial+, the interval resets to 150 ms.
Rate Response pacing parameters
Parameter
Programmable values
Upper Sensor Rate
80; 85 ... 120 ... 175 bpm
ADL Rate
60; 65 ... 95 ... 170 bpm
Rate Profile Optimization On ; Off
ADL Response
1; 2; 3 ; 4; 5
Exertion Response
1; 2; 3 ; 4; 5
Activity Threshold
Low ; Medium Low; Medium High; High
Activity Acceleration
15; 30 ; 60 s
Activity Deceleration
Exercise ; 2.5; 5; 10 min
ADL Setpoint
5; 6 ... 40; 42 ... 80
UR Setpoint
15; 16 ... 40; 42 ... 80; 85 ... 180
Rate Adaptive AV parameters
Parameter Rate Adaptive AV
Programmable values Off; On
Start Rate
50; 55 ... 90 ... 145 bpm
Stop Rate Minimum Paced AV
55; 60 ... 130 ... 175 bpm 30; 40 ... 100 ... 200 ms
Minimum Sensed AV
30; 40 ... 70 ... 200 ms
Atrial Rate Stabilization parameters
Parameter
Programmable values
A. Rate Stabilization
On; Off
Maximum Rate
80; 85 ... 100 ... 150 bpm
Interval Percentage Increment
12.5; 25 ; 50%
Atrial Preference Pacing parameters
Parameter
Programmable values
A. Preference Pacing
On; Off
Maximum Rate
80; 85 ... 100 ... 150 bpm
Interval Decrement
30 ; 40 ... 100; 150 ms
Search Beats
5; 10; 15; 20 ; 25; 50
Post Mode Switch Overdrive Pacing parameters
Parameter
Programmable values
Post Mode Switch Overdrive Rate
On; Off 70; 75; 80 ... 120 bpm
Overdrive Duration
0.5; 1; 2; 3; 5 ; 10; 20; 30; 60; 90; 120 min
Conducted AF response parameters
Parameter
Programmable values
Conducted AF Response On ; Off
Response Level
Low; Medium ; High
Maximum Rate
80; 85 ... 110 ... 130 bpm
Ventricular Rate Stabilization parameters
Parameter
Programmable values
V. Rate Stabilization
On; Off
Maximum Rate
80; 85 ... 100 ... 120 bpm
Interval Increment
100; 110 ... 150 ... 400 ms
Post VT/VF shock pacing parameters
Parameter
Programmable values
Post VT/VF Shock Pacing On; Off
Overdrive Rate
70; 75; 80 ... 120 bpm
Overdrive Duration
0.5 ; 1; 2; 3; 5; 10; 20; 30; 60; 90; 120 min
Post shock pacing parameters
Parameter
Programmable values
Post Shock A. Amplitude
1.0; 2.0; 3.0; 4.0 ; 5.0; 6.0; 8.0 V
Post Shock A. Pulse Width 0.1; 0.2 ... 1.5 ms
Post Shock V. Amplitudea Post Shock V. Pulse Widtha
1; 2 ... 6 ; 8 V 0.1; 0.2 ... 1.5 ms
a Applies to all ventricular chambers paced.
Rate Drop Response parameters
Parameter Rate Drop Responsea
Programmable values On; Off
Detection Type
Drop ; Low Rate; Both
Drop Size
10; 15 ... 25 ... 50 bpm
Drop Rate
30; 40 ... 60 ... 100 bpm
Detection Window
10; 15; 20; 25; 30 s 1 ; 1.5; 2; 2.5 min
Detection Beats
1; 2; 3 beats
Intervention Rate
70; 75 ... 100 ... 150 bpm
Intervention Duration
1; 2 ... 15 bpm
a When Rate Drop Response is programmed to On, the Lower Rate is automatically set to 45 bpm.
Sleep parameters Parameter Sleep Sleep Rate
Bed Time
Wake Time
Programmable values
On; Off
30; 35 ... 50 ; 55; 60; 70; 75 ... 100 bpm
00:00; 00:10 ... 22:00 ... 23:50
00:00; 00:10 ... 07:00 ... 23:50
Non-Competitive Atrial Pacing (NCAP) parameters
Parameter Non-Comp Atrial Pacing
Programmable values On ; Off
NCAP Interval
200; 250; 300 ; 350; 400 ms
MRI SureScan parameters Parameter MRI SureScan
MRI Pacing Mode
MRI Pacing Rate
Programmable values
On; Off
DOO (asynchronous); AOO (asynchronous); VOO (asynchronous); ODO (off)
60; 70; 75 ... 120 bpm
Additional pacing features
Parameter
Programmable values
PMT Intervention
On ; Off
PVC Response
On ; Off
V. Safety Pacinga
On ; Off
a Delivered as LV pacing when LV pacing is permanently programmed. Delivered as RV pacing when RV only pacing is permanently programmed. Otherwise, delivered as Bi-V pacing.
Medtronic CareAlertTM parameters
Clinical management alerts
Parameter
Programmable values
OptiVol 2.0 Fluid Settings
Device Tone and Wireless Alert
OptiVol Alert enable
Device Tone
Off ; On; Suspend 3 days; Suspend 5 days; Suspend 7 days; Suspend 14 days
Wireless Alert OptiVol Thresholdb
Off ; On 30; 40: 50; 60 ... 180
AT/AF Burden and Rate Settings
Device Tone and Wireless Alert
AT/AF Daily Burden
Off ; On
Daily AT/AF Burden
0.5; 1; 2; 6 ; 12; 24 h
Avg. V. Rate during AT/AF Off ; On
Avg. V. Rate during AT/AF Burden Time
0.5; 1; 2; 6 ; 12; 24 h
Avg. V. Rate during AT/AF 90; 100 ... 150 bpm
VT/VF Episodes and Therapies
Device Tone and Wireless Alert
Monitored VT Episode Detected
Off ; On
Thresholds
1 episode
Daily VT/VF Episodes
Off ; On
Thresholds
3 episodes/day
Weekly ATP Delivered Episodes
Off ; On
Thresholds
1 ; 2; 3; 4; 5
Number of Shocks Delivered in an Episoded
Off
; On
Thresholdsc
1 ; 2; 3; 4; 5; 6
Clinical management alerts, cont'd.
Parameter
Programmable values
Total VP < 90%
Device Tone and Wireless Alert
Off ; Ona
a Alert triggered if percent of cumulative right ventricular pacing is greater than 40% for 7 consecutive days. b Decreasing the OptiVol Threshold makes the device more sensitive to changes in the patient's thoracic fluid status. Increasing the OptiVol Threshold could delay or prevent device observation of significant changes in the patient's thoracic fluid status. c This parameter is displayed only if an associated alert has been enabled. d Note that VF, VT, and FVT therapies could be delivered during a single episode (from initial detection until episode termination).
Lead/device integrity alerts
Parameter
Programmable values
RV Lead
Device Tone and Wireless Alert
RV Lead Integrity
On ; Off
RV Lead Noise
On ; Off
Lead Impedance Out of Range
Device Tone and Wireless Alert
A. Pacing Enable
On ; Off
A. Pacing Less than
200 ; 300; 400; 500
A. Pacing Greater than 1,000; 1,500; 2,000; 3,000
RV Pacing Enable
On ; Off
RV Pacing Less than
200 ; 300; 400; 500
RV Pacing Greater than 1,000; 1,500; 2,000; 3,000
LV Pacing Enable
On ; Off
LV Pacing Less than
200 ; 300; 400; 500
LV Pacing Greater than
800; 1,000; 1,500; 2,000; 3,000
RV Defibrillation Enable
On ;Off
RV Defibrillation Less than 20 ; 30; 40; 50
RV Defibrillation Greater than
SVC Defibrillation Enablea
100; 130; 160; 200 On ; Off
SVC Defibrillation Less than
20 ; 30; 40; 50
SVC Defibrillation Greater than
100; 130; 160; 200
Capture Management High Threshold
Device Tone and Wireless Alert
A. Capture
Off ; On
RV Capture
Off ; On
LV Capture
Off ; On
Low Battery Voltage RRT
Device Tone and Wireless Alert
On ; Off
Excessive Charge Time EOS
Device Tone and Wireless Alert
On ; Off
VF Detection Off, 3+ VF or 3+ FVT Rx Off
Device Tone and Wireless Alert
On ; Off
a If an SVC lead is not implanted, the alert will not sound.
Shared parameters
Parameter
Programmable values
Wireless Telemetry with Monitor Alert Time (OptiVol)a
Alert Time (all others)a
On ; Off
00:00; 00:10 ... 10:10 ... 23:50b 00:00; 00:10 ... 08:00 ... 23:50b
a This parameter is displayed only if an associated alert has been enabled. b The implantable device app expresses time in the 24-hour format or in the 12-hour format, depending on your tablet settings.
Data collection parameters
Data collection parameters
Parameter
LECG Source (Leadless ECG)a
Programmable values
Can to SVC b,c; Can to Aring; RVcoil to Aring
LECG Range (Leadless ECG)
±1; ±2 ; ±4; ±8; ±12; ±16; ±32 mV
EGM 1 Source
RVtip to RVring; RVtip to RVcoil; Atip to RVring; Atip to Aring ; Aring to RVring; Aring to RVcoil
EGM 1 Range
±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mV
EGM 2 Source
Can to RVcoil ; Can to RVring; RVtip to RVcoil; RVtip to RVring; Can to SVCb,c; RVcoil to SVCb; LVtip to SVCb; Can to LVtip; RVtip to LVtip
EGM 2 Range
±1; ±2; ±4; ±8; ±12 ; ±16; ±32 mV
EGM 3 Source
RVtip to RVcoil; RVtip to RVring ; LVtip to LVringd; LVtip to RVring; LVtip to RVcoil; LVring to RVcoil; Can to RVcoil
EGM 3 Range
±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mV
Monitored
EGM1 and EGM2; EGM1 and EGM3 ; EGM2 and EGM3; EGM1 and LECG; EGM2 and LECG; EGM3 and LECG
Pre-arrhythmia EGM
Off; On Continuous
V. Sensing Episodes
Collect if Consecutive VS
5; 8; 10 ; 15; 20; 30; 40; 50; 100; 150; 200 senses
Data collection parameters, cont'd.
Parameter
Programmable values
End collection if Consecutive VP
2; 3 ; 5; 10 paces
Device Date/Timee
(select time zone)
Holter Telemetry Duration
Off ; 0.5; 1; 2; 4; 8; 16; 24; 36; 46 h
a This EGM channel displays far-field signals. To display an approximation of a surface ECG signal, choose the Can to SVC EGM source. b An SVC electrode must be present for this configuration. c If the Can to SVC source is selected, the EGM Range is automatically set to ±2 mV. The EGM Range is automatically set to ±8 mV for all other EGM Source options. d A bipolar LV lead must be present for this configuration. e The times and dates stored in episode records and other data are determined by the Device Date/Time clock.
CardioSyncTM Optimization test parameters
Sensing Lower Rate
30; 35 ... 60; 70; 75 ... 90 bpm
Pacing Lower Rate
35; 40 ... 60; 70; 75 ... 95 bpm
Wavelet Test parameters
Match Threshold
40; 43 ... 70 ... 97%
Modea
ODO; AAI; VVI; DDD; DDI
AV Delay
30; 40 ... 350 ms
Lower Rate
30; 35 ... 60; 70; 75 ... 120 bpm
a The selectable values for this parameter depend on the programmed pacing mode. b When performing the test in DDD mode, the Lower Rate must be less than the programmed Upper Tracking Rate. c The selectable values for this parameter depend on the programmed PVAB values.
System test parameters
System test parameters
Parameter
Selectable values
Pacing Threshold Test parameters
Test Type (Atrium or RV test)
Amplitude; Pulse Width
Test Type (LV test)
Amplitude; Pulse Width; Phrenic Nerve Stim -- Amplitude; Phrenic Nerve Stim -- Pulse Width
Chamber
Atrium; RV; LV
Decrement after
2; 3 ... 15 pulses
RV Pace Polarity
Bipolar; Tip to Coil
LV Pace Polarity
Modea (RV or LV Test) Modea (Atrium Test) Lower Rateb
LVtip to RVcoil; LVtip to LVring;LVring to RVcoil; LVring to LVtip
VVI; VOO; DDI; DDD; DOO
AAI; AOO; DDI; DDD; DOO
30; 35 ... 60; 70; 75 ... 150 bpm
RV Amplitude
0.25; 0.5 ... 5; 5.5; 6; 8 V
RV Pulse Width
0.03; 0.06; 0.1; 0.2 ... 1.5 ms
LV Amplitude
0.25; 0.5 ... 5; 5.5; 6; 8 V
LV Pulse Width
0.03; 0.06; 0.1; 0.2 ... 1.5 ms
A. Amplitude
0.25; 0.5 ... 5; 5.5; 6; 8 V
A. Pulse Width
0.03; 0.06; 0.1; 0.2 ... 1.5 ms
AV Delay
30; 40 ... 350 ms
V. Pace Blanking
150; 160 ... 450 ms
A. Pace Blanking
150; 160 ... 250 ms
PVARPc
150; 160 ... 500 ms
Sensing Test parameters Modea
AAI; DDD; DDI; VVI; ODO
AV Delay Lower Rateb
30; 40 ... 350 ms 30; 35 ... 60; 70; 75 ... 120 bpm
EP study parameters
T-Shock parameters
Parameter Chambera
Selectable values RV ; LV; RV+LV
Resume at Deliver
Enabled ; Disabled
Enable
Enabled; Disabled
#S1
2; 3; 4; 5 ; 6; 7; 8
S1S1
300; 310 ... 400 ... 2,000 ms
Delay
20; 30 ... 300 ... 600 ms
Energy/Pathway
Energy Pathwayb
0.4; 0.6; 0.8; 1.0 ... 1.8; 2; 3; 4 ... 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35; 40 J
AX>B; B>AX
Waveform
Monophasic ; Biphasic
a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first. b If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not used as part of the high-voltage delivery pathway. If the Active Can/SVC Coil parameter is set to SVC Off, the SVC Coil electrode is not used as part of the high-voltage delivery pathway.
50 Hz Burst parameters
Parameter
Selectable values
Resume at Burst
Enabled ; Disabled
Chamber Amplitudea Pulse Widtha
Atrium; RV; LV 1; 2; 3; 4 ; 5; 6; 8 V 0.10; 0.20 ... 0.50 ... 1.50 ms
VOO Backup (for atrial 50 Hz burst)b
On; Off
Pacing Rate
60; 70 ... 120 bpm
V. Amplitudec,d
0.50; 0.75 ... 5.00; 5.50; 6.00; 8.00 V
V. Pulse Widthc,d
0.10; 0.20 ... 1.50 ms
a Applies to all ventricular chambers paced. b If V. Pacing is set to RV, RVLV, or LVRV, then backup pacing is delivered to the RV chamber. If V. Pacing is set to LV, then backup pacing is delivered to the LV chamber. c The default value for this parameter is set according to the permanently programmed settings for bradycardia pacing. d Crosstalk may occur when atrial pacing amplitude is > 6.0 V.
Fixed Burst parameters
Parameter
Selectable values
Resume at Burst Chambera
Enabled ; Disabled Atrium; RV; RV+LV; LV
Interval Amplitudeb Pulse Widthb
100; 110 ... 600 ms 1; 2; 3; 4 ; 5; 6; 8 V 0.10; 0.20 ... 0.50 ... 1.50 ms
VVI Backup (for atrial fixed burst)c
On; Off
Pacing Rate
60; 70 ... 120 bpm
V. Amplituded,e
0.50; 0.75 ... 5.00; 5.50; 6.00; 8.00 V
V. Pulse Widthd
0.10; 0.20 ... 1.50 ms
a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first. b Applies to all ventricular chambers paced. c If V. Pacing is set to RV, RVLV, or LVRV, then backup pacing is delivered to the RV chamber. If V. Pacing is set to LV, then backup pacing is delivered to the LV chamber. d The default value for this parameter is set according to the permanently programmed settings for bradycardia pacing. e Crosstalk may occur when atrial pacing amplitude is > 6.0 V.
PES induction parameters
Parameter
Selectable values
Resume at Deliver
Enabled ; Disabled
Chambera
Atrium; RV; RV+LV; LV
#S1
1; 2 ... 8 ... 15
S1S1
100; 110 ... 600 ... 2,000 ms
S1S2
On; Off; 100; 110 ... 400 ... 600 ms
S2S3
On; Off ; 100; 110 ... 600 msb
S3S4
On; Off ; 100; 110 ... 600 msb
Amplitudec
1; 2; 3; 4 ; 5; 6; 8 V
Pulse Widthc
0.10; 0.20 ... 0.50 ... 1.50 ms
VVI Backup (for atrial PES)d On; Off
Pacing Rate
60; 70 ... 120 bpm
V. Amplitudee,f
0.50; 0.75 ... 5.00; 5.50; 6.00; 8.00 V
V. Pulse Widthe
0.10; 0.20 ... 1.50 ms
a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first. b Default value when parameter is programmed to On is 400 ms. c Applies to all ventricular chambers paced. d If V. Pacing is set to RV, RVLV, or LVRV, then backup pacing is delivered to the RV chamber. If V. Pacing is set to LV, then backup pacing is delivered to the LV chamber. e The default value for this parameter is set according to the permanently programmed settings for bradycardia pacing. f Crosstalk may occur when atrial pacing amplitude is > 6.0 V.
Defibrillation parameters
Parameter
Selectable values
Chamber
RV
Energy
0.4; 0.6 ... 1.8; 2; 3 ... 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35; 40 J
Pathwaya
AX>B; B>AX
a If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not used as part of the high-voltage delivery pathway. If the Active Can/SVC Coil parameter is set to SVC Off, the SVC Coil electrode is not used as part of the high-voltage delivery pathway.
Cardioversion parameters
Parameter
Selectable values
Chamber
Atrium; RV
Energy Pathwaya
0.4; 0.6 ... 1.8; 2; 3 ... 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35; 40 J
AX>B; B>AX
Minimum R-R (atrial CV only) 400; 410 ... 500 ... 600 ms
a If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not used as part of the high-voltage delivery pathway. If the Active Can/SVC Coil parameter is set to SVC Off, the SVC Coil electrode is not used as part of the high-voltage delivery pathway.
Shared ATP parametersa
Parameter
Selectable values
Minimum Interval (atrial ATP) 100; 110; 120; 130 ... 400 ms
Minimum Interval (ventricular ATP)
Amplitudeb
Pulse Widthb
150; 160 ... 200 ... 400 ms
1; 2 ... 6 ; 8 V 0.10; 0.20 ... 1.50 ms
VVI Backup (for atrial ATP studies)c
On; Off
Pacing Rate
60; 70 ... 120 bpm
V. Amplituded,e
0.50; 0.75 ... 5.00; 5.50; 6.00; 8.00 V
V. Pulse Widthd
0.10; 0.20 ... 1.50 ms
a Ramp, Burst, Ramp+ and Burst+. b Applies to all ventricular chambers paced. c If V. Pacing is set to RV, RVLV, or LVRV, then backup pacing is delivered to the RV chamber. If V. Pacing is set to LV, then backup pacing is delivered to the LV chamber. d The default value for this parameter is set according to the permanently programmed settings for bradycardia pacing. e Crosstalk may occur when atrial pacing amplitude is > 6.0 V.
Ramp parameters
Parameter Chambera
Selectable values Atrium; RV; RV+LV; LV
Ventricular Ramp study parameters
# Pulses
1; 2 ... 6 ... 15
%RR Interval
50; 53; 56; 59; 63; 66 ... 84; 88; 91; 94; 97 %
Dec/Pulse
0; 10 ; 20; 30; 40 ms
Atrial Ramp study parameters
# Pulses
1; 2 ... 6 ... 15; 20; 30 ... 100
%AA Interval
28; 31; 34; 38; 41 ... 59; 63; 66 ... 84; 88; 91; 94; 97 %
Dec/Pulse
0; 10 ; 20; 30; 40 ms
a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first.
Burst parameters
Parameter Chambera
Selectable values RV ; RV+LV; LV
# Pulses
1; 2 ... 8 ... 15
%RR Interval
50; 53; 56; 59; 63; 66 ... 84; 88 ; 91; 94; 97%
a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first.
Ramp+ parameters
Parameter Chambera
Selectable values RV ; RV+LV; LV
# Pulses
1; 2; 3 ... 15
R-S1 (%RR)
50; 53; 56; 59; 63; 66 ... 75 ... 84; 88; 91; 94; 97%
S1S2 (%RR)
50; 53; 56; 59; 63; 66; 69 ... 84; 88; 91; 94; 97%
S2SN (%RR)
50; 53; 56; 59; 63; 66 ... 84; 88; 91; 94; 97%
a If the chamber selected is RV+LV, the delay is set to 2.5 ms with LV pace delivered first.
Burst+ parameters Parameter Chamber #S1 Pulses
%AA Interval
S1S2
S2S3 Dec
a This value is nonprogrammable.
Selectable values Atriuma
1; 2 ... 6 ... 15; 20; 30 ... 100
28; 31; 34; 38; 41 ... 59; 63; 66 ... 84; 88; 91 ; 94; 97%
Off; 28; 31; 34; 38; 41 ... 59; 63; 66 ... 84 ; 88; 91; 94; 97%
Off; 0; 10; 20 ... 80 ms
Longevity
Projected service life in years
RA amplitude/pace % RV amplitude/pace % LV amplitude/pace % Projected service life per impedance
1.5 V, 0% 1.5 V, 13% 1.5 V, 100%
2.0 V, 100% 2.0 V, 100% 2.0 V, 100%
1.75 V, 100% 1.75 V, 100% 1.75 V, 100%
500 9.6 yearsa
9.4 yearsa
RA 435 /RV 430 /LV 568 9.5 yearsb
2.5 V, 15%
2.5 V, 100%
2.5 V, 100%
8.3 years
600 : 8.7 years
a Per EN 45502-2-2 or ISO 14708-6 for paced percentage and lead impedance. b Based on median CareLinkTM settings for amplitude, paced percentage, and lead impedance.
The service life projections are based on the following assumptions: § Semi-annual maximum energy charging frequency § A quarterly schedule of remote telemetry transmissions § Typical shelf storage time before implant § 1 hour of wireless telemetry during implant § 1 hour of in-office wireless telemetry annually
Projected service life estimates are based on accelerated battery discharge data and device modeling as specified. Do not interpret these values as precise numbers.
Brief Statement CobaltTM/CromeTM MRI SureScanTM ICD and CRT-D Systems Indications: The Cobalt and Crome HF CRT-D MRI SureScan systems are indicated for use in patients who are at significant risk of developing atrial and/or life-threatening ventricular arrhythmias and who have heart failure with ventricular arrhythmias. Heart failure patients must have experienced one or more of the following conditions: § NYHA Functional Class III or IV patients who remain symptomatic despite stable, optimal medical
therapy and have LVEF 35% and a prolonged QRS duration § NYHA Functional Class II patients who have left bundle branch block (LBBB) with a QRS duration
130 ms and a left ventricular ejection fraction 30% § NYHA Functional Class I, II, or III who are on stable, optimal medical therapy (if indicated) and have
LVEF 50%, atrioventricular block (AV block), and are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing The Cobalt and Crome VR and DR ICD MRI SureScan systems are indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, atrial and/or life-threatening ventricular arrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies. MRI Conditions for Use: Medtronic SureScan ICD and CRT-D systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. ICD and CRT-D SureScan system patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. A complete SureScan defibrillation system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com/. Any other combination may result in a hazard to the patient during an MRI scan.
Medtronic 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA
Toll-free in USA: 800.633.8766 Worldwide: +1.763.514.4000
Contraindications: The Cobalt and Crome VR and DR ICD, and CRT-D MRI SureScan systems are contraindicated for use in the following situations: § If implanted with a unipolar pacemaker § If incessant VT or VF exists § If the primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF § If tachyarrhythmias with transient or reversible causes exist, including the following known issues:
acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, and sepsis Warnings and Precautions: Changes in a patient's disease and/or medications may alter the efficacy of the device's programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Patients and their implanted systems must be screened to meet the following requirements for MRI: no lead extenders, lead adaptors, or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; the device must be operating within the projected service life; and the system must be implanted in the left or right pectoral region. Potential Adverse Events: Potential adverse events include, but are not limited to, the following events: allergic reactions, atrial fibrillation, bradyarrhythmia, cardiac arrest, device migration, discomfort, dizziness, dyspnea, erosion, excessive fibrotic tissue growth, heart failure or loss of CRT (for CRT-D patients), hematoma, hemorrhage, inability to deliver therapy, inappropriate shock, infection, lead migration/dislodgement, lethargy, loss of pacing, mental anguish, necrosis, nerve damage, oversensing, palpitations, seroma, syncope, tachyarrhythmia, tissue damage due to heating of the device, undersensing, and wound dehiscence. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, spontaneous tachyarrhythmia, potential for VT/VF induction, device heating that results in tissue damage, stimulation of the leads that results in continuous capture, VT/VF, hemodynamic collapse, damage to the device or the leads, causing the system to fail or treat the patient's condition incorrectly, and movement or vibration of the device or the leads, resulting in dislodgement. See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and adverse events. See the MRI SureScan Technical Manual before performing an MRI Scan. For further information, call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com or mrisurescan.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
medtronic.com
UC202001912 EN ©2020 Medtronic. Minneapolis, MN. All Rights Reserved. Printed in USA. 04/2020
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