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ENRHYTHM MRI
™
SURESCAN® PACING SYSTEM
Software Application Model SW005
Software Application Model SW005 is approved for commercial
use and available for download on Medtronic CareLink Model
2090 Programmer. For more information about this software,
please contact Technical Services at 877-674-7677.
Technical Manual
Caution: Federal Law (USA) restricts this device to sale by or
on the order of a physician.
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The following list includes trademarks or registered trademarks of Medtronic in the United States and
possibly in other countries. All other trademarks are the property of their respective owners.
Checklist, EnRhythm, EnRhythm MRI, Medtronic, Medtronic CareLink, Quick Look, SureScan
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Contents
1 Introduction 5
2 MRI conditions for use 5
3 MRI warnings and precautions 6
4 Potential adverse events 6
5 Cardiology-specific considerations 6
6 Radiology-specific requirements 7
6.1 MRI requirements 7
6.2 Patient safety during the MRI scan 7
6.3 MRI considerations 7
6.4 Patient positioning restrictions within the MRI bore 8
6.5 Allowed scan types 8
7 Pre-MRI scan operations 9
7.1 Identification of SureScan pacing system components 9
7.2 Preparing a SureScan device for an MRI scan 9
7.3 Required patient care 10
8 Performing an MRI scan 10
8.1 SureScan pacing system integrity verification 10
8.2 Programming MRI SureScan to On 11
8.3 Device considerations 13
8.4 Radiology considerations during the MRI scan 14
9 Following the MRI scan 14
9.1 Returning the device to the pre-MRI configuration 14
10 Explanation of symbols 15
11 Medtronic warranty information 15
12 Service 15
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1 Introduction
The SureScan pacing system is MR Conditional and, as such, is designed to allow patients to be safely scanned
by an MRI machine when used according to the specified MRI conditions for use. When programmed to On, the
MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate
pacing. It is important to read this manual before conducting an MRI scan on a patient with an implanted SureScan
pacing system. Clinical and pre-clinical testing has demonstrated that the SureScan pacing system is safe for
use in the MRI environment when used according to the instructions in this manual. Contact a Medtronic
representative if you have further questions.
Refer to the appropriate Medtronic device reference manual or lead technical manual for non-MRI
related instructions for use.
2 MRI conditions for use
A complete SureScan pacing system including a EnRhythm MRI SureScan IPG and two SureScan leads
is required for use in the MRI environment. Any other combination may result in a hazard to the patient during
an MRI scan. The SureScan feature must be programmed to On prior to scanning a patient according to the
specified conditions for use.
Cardiology requirements:
●
Patients and their implanted systems must be screened to meet the following requirements:
– no previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors
– no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history
– a SureScan pacing system that has been implanted for a minimum of 6 weeks
– a SureScan pacing system implanted in the left or right pectoral region
– pacing capture thresholds of ≤ 2.0 volts (V) at a pulse width of 0.4 milliseconds (ms)
– a lead impedance value of ≥ 200 ohms (Ω) and ≤ 1500 Ω
– no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose
device will be programmed to an asynchronous pacing mode when MRI SureScan is on
Radiology requirements:
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Horizontal cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) must be
used.
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Gradient systems with maximum gradient slew rate performance per axis of ≤ 200 Teslas per meter per
second (T/m/s) must be used.
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The scanner must be operated in Normal Operating Mode:
– The whole body averaged specific absorption rate (SAR) must be ≤ 2.0 watts per kilogram (W/kg).
– The head SAR must be < 3.2 W/kg.
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The patient must be positioned within the bore such that the isocenter (center of the MRI bore) is superior to
the C1 vertebra or inferior to the T12 vertebra.
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Proper patient monitoring must be provided during the MRI scan. The methods include visual and verbal
contact with the patient, electrocardiography, and pulse oximetry (plethysmography).
Training requirements:
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A health professional who has completed cardiology SureScan training must be present during the
programming of the SureScan feature.
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A health professional who has completed radiology SureScan training must be present during the MRI scan.
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3 MRI warnings and precautions
Warnings:
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Do not scan patients who do not have a complete SureScan pacing system, which includes a SureScan
device and two SureScan leads. Any other combination may result in a hazard to the patient during an MRI
scan.
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Do not scan patients with broken or intermittent leads. Lead fractures or other damage to the leads may cause
changes in the electrical properties of the SureScan pacing system that will make the system unsafe for an
MRI scan. Patients with damaged leads may be harmed if an MRI scan is performed.
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Do not scan patients with a SureScan pacing system implanted in sites other than the left and right pectoral
region. This device implant location helps to prevent lead electrode heating due to RF energy and unintended
cardiac capture due to the gradient magnetic fields.
●
Do not scan patients with a lead impedance value of < 200 Ω or > 1500 Ω. If either of the bipolar lead
impedance measurements is < 200 Ω or > 1500 Ω or is unavailable, the device software prevents the MRI
SureScan feature from being initiated.
Cautions:
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Do not scan patients with a whole body averaged SAR level > 2.0 W/kg. A scan above 2.0 W/kg may increase
the risk of myocardial tissue damage due to lead tip heating, resulting in an increase in the pacing capture
threshold.
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Do not scan patients with pacing capture threshold values of > 2.0 V at a pulse width of 0.4 ms. The higher
pacing capture threshold indicates there may be an issue with the implanted lead.
●
Do not scan patients with previously implanted (active or abandoned) medical devices, leads, lead extenders,
or lead adaptors as it may increase the risk of myocardial tissue damage due to lead tip heating and other
MRI RF field-related hazards. The interaction with other implantable devices has not been evaluated by
Medtronic.
●
Do not scan patients whose device will be programmed to an asynchronous pacing mode when MRI
SureScan is on, and who have diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of
1.0 ms. It may be difficult for the patient to remain still in order to obtain a quality image.
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Do not scan the patient positioned such that the isocenter (center of the MRI bore) is inferior to the C1 vertebra
and superior to the T12 vertebra as it may cause myocardial damage due to lead tip heating, resulting in an
increase in pacing capture threshold. This has not been studied clinically by Medtronic.
4 Potential adverse events
The SureScan pacing system has been designed to minimize the potential adverse events that may cause patient
harm. The following potential adverse events may occur in the MRI environment:
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lead electrode heating and tissue damage resulting in loss of sensing or capture or both
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device heating resulting in tissue damage in the implant pocket or patient discomfort or both
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induced currents on leads resulting in continuous capture, VT/VF, hemodynamic collapse, or all three
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damage to the device or leads causing the system to fail to detect or treat irregular heartbeats or causing the
system to treat the patient’s condition incorrectly
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damage to the functionality or mechanical integrity of the device resulting in the inability of the device to
communicate with the programmer
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movement or vibration of the device or leads resulting in dislodgment
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competitive pacing and potential for VT/VF induction due to ambulatory asynchronous pacing in MRI
SureScan mode
5 Cardiology-specific considerations
Competitive pacing – If an asynchronous MRI SureScan pacing mode is selected, be aware that some patients
may be susceptible to cardiac arrhythmia induced by competitive pacing. For these patients, it is important to first
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select an MRI SureScan pacing rate that avoids competitive pacing and then minimize the duration of the
asynchronous pacing operation.
System information and records – All pertinent information about the components of the implanted SureScan
pacing system, such as model names, model numbers, and serial numbers, should be recorded in the patient
record and on the Patient Information Screen on the programmer.
Patient ID card – Reference materials, such as an ID card, should be provided to all patients with an implanted
SureScan pacing system. These reference materials should indicate that the patient has a SureScan IPG and
two SureScan leads.
6 Radiology-specific requirements
6.1 MRI requirements
The MRI requirements listed in this section must be satisfied during all MRI scans performed on patients with a
SureScan pacing system. If you are unsure of the capabilities of your MRI machine, contact the MRI manufacturer.
MRI equipment operating characteristics – The safety and reliability of the SureScan pacing system has been
evaluated for scanning patients using MRI equipment that has the following operating characteristics:
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hydrogen proton magnetic resonance imaging equipment with a static magnetic field of 1.5 T, operating at a
frequency of 64 MHz
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cylindrical bore magnet, clinical MRI systems
●
gradient systems with a maximum gradient slew rate performance per axis of 200 T/m/s or less
MRI radio frequency (RF) power – The MRI scanner must be operated in Normal Operating Mode:
●
The whole body averaged SAR must be ≤ 2.0 W/kg.
●
The head SAR must be < 3.2 W/kg.
6.2 Patient safety during the MRI scan
Patient monitoring – Proper patient monitoring must be provided during the MRI scan. This includes the
following methods:
●
visual and verbal contact with the patient
●
electrocardiography
●
pulse oximetry (plethysmography)
Preparation for patient rescue – An external defibrillator must be available nearby during the MRI scan.
Note: If the patient’s hemodynamic function is compromised during the MRI scan, discontinue the MRI scan,
remove the patient from the magnet room, and take the proper measures to restore the patient’s hemodynamic
function.
6.3 MRI considerations
Use of transmit/receive and receive-only coils – As long as the patient positioning and centering criteria are
followed, there are no restrictions on the use of local transmit/receive coils for imaging of the head or of the
extremities, and there are no restrictions on the placement of receive-only coils.
Multiple MRI scans – The effect of multiple MRI scans on a patient has not been evaluated clinically. While the
clinical study was not designed to evaluate the effects of multiple MRI scans, 15 patients received multiple MRI
scans due to medical need during the course of the clinical trial. In these 15 patients, there was no observed
impact on electrical performance due to multiple MRI scans and there were no MRI-related complications.
Image artifact and distortion – SureScan leads have demonstrated minimal image distortion for areas
surrounding the implanted leads when the device is out of the field of view. Significant image distortion can result
from the presence of the device within the field of view. Image artifacts and distortion resulting from the presence
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of the device and the leads within the field of view must be considered when selecting the field of view and imaging
Isocenter (center of
the MRI bore)
Isocenter (center of
the MRI bore)
C1
T12
parameters. These factors must also be considered when interpreting the MRI images.
6.4 Patient positioning restrictions within the MRI bore
Cautions:
●
The SureScan pacing system is compatible only with certain MRI scan procedures. Safely imaging a patient
with an implanted SureScan pacing system is dependent upon compliance to the MR conditional criteria
described in this section. Before starting the imaging procedure, confirm the patient’s position as described
here.
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Do not scan the patient positioned such that the isocenter (center of the MRI bore) is inferior to the C1 vertebra
and superior to the T12 vertebra (see Figure 1) as it may cause myocardial damage due to lead heating,
resulting in an increase in pacing capture threshold. This has not been evaluated clinically by Medtronic.
Figure 1. Patient positioning criteria
1 The dashed line labeled “C1” depicts a transverse plane adjacent to the superior surface of the C1 vertebra.
2 The dashed line labeled “T12” depicts a transverse plane adjacent to the inferior surface of the T12 vertebra.
Examples of allowed imaging include the brain, lumbar spine, and lower extremities. Images within the C1 vertebra
and the T12 vertebra (for example, the cervical spine, elbow, thoracic spine, and liver) may still be obtained as
long as the patient positioning criteria are followed. This may require modification of scan sequences.
6.5 Allowed scan types
Localizer scans – All position localizer scans are allowed. These scans may be used to confirm compliance with
the patient positioning criteria as described in Section 6.4 during diagnostic scans. If the localizer scan image
indicates that the patient is positioned such that the isocenter (center of the MRI bore) is between C1 and T12,
reposition the patient and confirm that the new relationship complies with the patient positioning criteria as
described.
Diagnostic scans – All standard diagnostic scans of anatomies may be performed if the patient positioning
criteria are followed. Achieving diagnostic-quality imaging of the desired anatomies may require manipulation of
the scan parameters used during normal practice, for example: Field of View.
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7 Pre-MRI scan operations
The steps in the following sections are required before performing an MRI scan.
7.1 Identification of SureScan pacing system components
The following are three ways to verify that a patient has SureScan pacing system components:
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Radiopaque MRI symbols: A radiopaque MRI symbol is present on all implanted SureScan pacing system
components. By taking an x-ray of the implanted system, the clinician can verify whether the components
have SureScan technology. An x-ray also indicates whether the patient has any additional active implantable
devices.
The device radiopaque MRI symbol is located in the header of the can. The radiopaque MRI symbol is a wavy
line located in the upper portion of the full device radiopaque. A similar wavy line is visible on the lead, adjacent
to the can and lead interface. See Figure 2 for the device and lead radiopaque MRI symbols and their
locations.
Figure 2. Radiopaque MRI symbols and their locations
1 Location of the device radiopaque symbol
3 Lead radiopaque MRI symbol
2 Device radiopaque MRI symbol
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Patient records or patient ID card (if applicable): The patient records or patient ID card, if applicable,
must be complete and accurate if they are to be used to verify that the patient has a SureScan pacing system
and to determine whether the patient has any additional active implantable devices.
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Patient information on the programmer: The patient information must be complete and accurate on the
programmer if this feature is to be used to determine whether the patient has a SureScan pacing system and
to determine whether the patient has any additional active implantable devices.
7.2 Preparing a SureScan device for an MRI scan
The following tasks must be completed before performing an MRI scan on a patient with a SureScan pacing
system:
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Check that the SureScan pacing system has been implanted for more than 6 weeks: The 6-week
post-implant waiting period allows the device and lead to become fixated in the patient. Maturation of the lead
and tissue interface increases the stability of the pacing capture threshold.
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Check that the device was implanted in the pectoral region: A device that is implanted in the pectoral
region limits the lead loop area. This device implant location helps to prevent lead electrode heating due to
RF energy and unintended cardiac capture due to the gradient magnetic fields.
●
Check that no additional implantable devices are present: Interactions with all other implantable
devices, active or abandoned, have not been studied by Medtronic. Patients can be considered safe for an
MRI scan only if no other implantable devices are present.
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Check that the leads are labeled as SureScan leads: Leads other than SureScan leads have not been
tested by Medtronic. Patients can be considered safe for an MRI scan only if the implanted system consists
of a SureScan device connected to two SureScan leads.
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Check that the leads are electrically intact: Lead fractures or other damage to the leads may cause
changes in the electrical properties of the SureScan pacing system that will make the system unsafe for an
MRI scan. Patients with damaged leads may be harmed if an MRI scan is performed.
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Check that abandoned or additional leads are not present: Abandoned or additional leads have not
been tested by Medtronic. Patients can be considered safe for an MRI scan only if no other implanted leads
are present.
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Check that no lead extenders or adaptors are present: Lead extenders or adaptors are not considered
part of the SureScan pacing system, and they have not been designed for MRI use. Use of lead extenders
or adaptors with the SureScan pacing system components may change important parameters that are
designed to prevent lead tip heating due to RF energy and unintended cardiac capture due to the gradient
magnetic fields.
7.3 Required patient care
Verify that the pacing capture threshold values are ≤ 2.0 V at a pulse width of 0.4 ms.
Note: Patients experiencing atrial fibrillation may be scanned if all other pre-MRI scan requirements are satisfied.
Maximum pacing capture threshold – The patient’s atrial and ventricular pacing capture thresholds must be
evaluated before performing an MRI scan. If either the atrial or ventricular capture threshold exceeds 2.0 V at a
pulse width of 0.4 ms, there may be an issue with the implanted lead.
Pacing therapy during MRI scans – Each patient must be evaluated to determine whether or not pacing support
is needed during the MRI scan. For patients that require pacing support, the MRI SureScan pacing mode must
be set to DOO, AOO, or VOO while MRI SureScan is programmed to On. For patients that do not require pacing
support, the MRI SureScan pacing mode should be set to ODO while MRI SureScan is programmed to On.
Pacing rate – The appropriate pacing rate for patients who require pacing support must be determined before
performing the MRI scan. The pacing rate must be selected to avoid competitive pacing during MRI SureScan
operation.
8 Performing an MRI scan
Caution: Do not bring the Medtronic CareLink Model 2090 programmer into Zone 4 (magnet room), as defined
by the American College of Radiology. It is MRI Unsafe.
To safely perform an MRI scan on a patient with the SureScan pacing system, MRI SureScan must be
programmed to On using the 2090 programmer. To program MRI SureScan, the user must select parameters
that are appropriate for the patient when the MRI scan is performed.
Note: Pacing mode and rate (if applicable) are to be programmed per the physician’s discretion. Based on
whether the patient needs pacing support or not, an asynchronous pacing mode (DOO, AOO, or VOO) or sensing
only mode (ODO) can be programmed. Sensed events will be ignored by the device when MRI SureScan is
programmed to On, regardless of the programmed mode.
The device maintains the selected parameters until MRI SureScan is programmed to Off after the MRI scan is
done. After MRI SureScan is programmed to Off, the permanent device parameters are restored.
8.1 SureScan pacing system integrity verification
The SureScan pacing system provides automatic verification that no device or lead issues that may compromise
patient safety during an MRI scan are detected. Before allowing the user to initiate the MRI SureScan feature,
the SureScan device application software checks for the following 2 situations:
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Lead impedance is out of range – If either of the bipolar lead impedance measurements is greater than
1500 Ω, is less than 200 Ω, or is unavailable, the software prevents the MRI SureScan feature from being initiated.
Insufficient battery longevity – If the device is at Recommended Replacement Time (RRT) or End of Service
(EOS), the software prevents the MRI SureScan feature from being initiated.
Note: If the battery voltage is at or below 2.85 V, the user is notified that the device is nearing the RRT threshold.
(See Figure 3). The MRI SureScan feature may be programmed to On; however, prolonged use of the MRI
SureScan feature may lead to an early, undetected RRT.
Figure 3. Programmer display: Device is nearing the RRT threshold
8.2 Programming MRI SureScan to On
Use the following steps to program MRI SureScan to On:
1. Select the Params icon from the tool palette.
2. Select Additional Features… on the Parameters screen.
3. Select the MRI SureScan… field (see Figure 4). The MRI SureScan Checklist appears.
Figure 4. Selecting the MRI SureScan… field
4. Select the check box in the upper-left corner if all items on the MRI SureScan Checklist are satisfied for the
patient (see Figure 5).
Note: Print the MRI SureScan Checklist if desired.
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Figure 5. MRI SureScan Checklist
5. Select [OK]. The MRI SureScan window appears.
6. Program MRI SureScan to On.
7. Select an appropriate MRI SureScan pacing mode and MRI SureScan pacing rate (see Figure 6).
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For patients who require pacing support, program the device to an asynchronous pacing mode (DOO,
AOO, VOO).
Note: An MRI SureScan pacing rate must be selected for these pacing modes to avoid competitive
pacing during the operation of MRI SureScan.
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For patients who do not require pacing support, program the device to the non-pacing mode (ODO).
Note: An MRI SureScan pacing rate is not necessary for patients whose device is programmed to ODO.
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Figure 6. Selecting MRI SureScan settings
8. Select [PROGRAM].
Note: After the device has been programmed for an MRI scan, available options are [Print…], [End
Session…], and [Emergency]. MRI SureScan can also be programmed to Off.
Note: The status of MRI SureScan and the programmed parameters may be confirmed by printing the MRI
SureScan parameter screen.
The device is now ready for the MRI scan.
8.3 Device considerations
Suspension of diagnostics and counters – When MRI SureScan is programmed to On, the following device
diagnostics and counters are suspended:
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Daily Automatic EGM Amplitude Measurements
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Daily Automatic Battery Measurement
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Daily Automatic Lead Impedance Measurements
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Daily Atrial Lead Position Check
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Short Interval Counter
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Bradycardia Event Counters
Suspension of Magnet Mode – When MRI SureScan is programmed to On, the device does not initiate
asynchronous, fixed-rate bradycardia pacing in the presence of a magnet.
Suspension of tachyarrhythmia and PVC detection – When MRI SureScan is programmed to On, the device
does not detect atrial or ventricular tachyarrhythmias or PVCs.
Suspension of tachyarrhythmia therapies – When MRI SureScan is programmed to On, the device does not
deliver tachyarrhythmia therapies. However, bradyarrhythmia pacing therapy is provided when an asynchronous
pacing mode is selected for MRI SureScan operation.
Automatic PAV selection for MRI DOO mode – If DOO mode is selected when MRI SureScan is programmed
to On, the device automatically sets the PAV to either the permanently programmed PAV interval or 110 ms,
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whichever is less. However, if the permanently programmed PAV is less than 50 ms, the device automatically
sets the PAV to 50 ms when MRI SureScan is programmed to On.
Automatic amplitude and pulse width selection for MRI SureScan pacing modes – When MRI SureScan
is programmed to On and the pacing mode is DOO, VOO, or AOO, the device may automatically reset the
amplitude and pulse width values. If the permanently programmed RA Amplitude or RV Amplitude is less than
5.0 V, the amplitude is reset to 5.0 V. If the permanently programmed RA Pulse Width or RV Pulse Width is less
than 1.0 ms, the pulse width is reset to 1.0 ms.
Increased current drain – When MRI SureScan is programmed to On, the current drain from the battery is
increased. Therefore, the feature should be programmed off following the MRI scan to prevent significant
reduction in battery longevity.
No RRT indication – When MRI SureScan is programmed to On, if the battery voltage falls below 2.81 V, the
normal RRT indication may not be displayed.1 If the feature is left on indefinitely, the patient will have no indication
that the device has reached RRT.
8.4 Radiology considerations during the MRI scan
Patient monitoring – Proper patient monitoring must be provided during the MRI scan. This includes the
following methods:
●
visual and verbal contact with the patient
●
electrocardiography
●
pulse oximetry (plethysmography)
Preparation for patient rescue – An external defibrillator must be available nearby during MRI scans.
Note: If the patient’s hemodynamic function is compromised during the MRI scan, discontinue the MRI scan,
remove the patient from the magnet room, and take the proper measures to restore the patient’s hemodynamic
function.
9 Following the MRI scan
Required patient care – The following steps are required after performing an MRI scan:
●
Program MRI SureScan to Off.
●
Check the pacing capture threshold to ensure that there is a proper safety margin.
IPG capture output resolution – The Medtronic EnRhythm MRI SureScan EMDR01 IPG measures pacing
capture threshold in 0.5 V increments. The actual pacing capture threshold change associated with a 0.5 V change
is between 0.0 V and 1.0 V. For example, actual thresholds of 1.49 V and 1.51 V correspond to measured
thresholds of 1.5 V and 2.0 V respectively. In this case, an actual change of 0.02 V results in a measured change
of 0.5 V. Similarly, actual thresholds of 1.01 V and 2.00 V correspond to measured thresholds of 1.5 V and 2.0 V.
In this situation, an actual change of 0.99 V results in a measured change of 0.5 V.
9.1 Returning the device to the pre-MRI configuration
Note: The device maintains the parameters that were set while initiating the SureScan feature until the MRI
SureScan parameter is programmed to Off after the MRI scan.
After the MRI scan is complete, MRI SureScan must be programmed to Off using the 2090 programmer. This
restores the device parameter values to the pre-MRI SureScan configuration.
1
RRT indication consists of the following indicators: automatic mode programming to VVI; automatic Lower
Rate programming to 65 bpm; atrial ATP automatically disabled; response to application of magnet = VOO,
65 bpm; upon interrogation, an RRT warning message is displayed to the user.
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Perform the following steps to program MRI SureScan to Off:
1. Program the MRI SureScan parameter to Off.
2. Select [PROGRAM].
3. Select [Close] to return to the Additional Features window. Select [OK] to return to the Parameters screen.
The device parameter values are now restored to the pre-MRI SureScan configuration.
Note: During each interrogation, the device is monitored for possible electrical reset conditions and disabled
therapies. If a condition is detected that requires attention, the programmer displays a Device Status Indicator
warning in a pop-up window and on the Quick Look screen.
10 Explanation of symbols
The labeling for SureScan pacing system components displays the SureScan symbol and the MR Conditional
symbol.
SureScan symbol
MR Conditional symbol
11 Medtronic warranty information
Please see the literature enclosed with the products for information regarding the product warranty or disclaimer
of warranty as applicable.
12 Service
Medtronic employs highly trained representatives and engineers located throughout the world to serve you and,
upon request, to provide training to qualified hospital personnel in the use of Medtronic products. Medtronic also
maintains a professional staff to provide technical consultation to product users. For more information, contact
your local Medtronic representative, or call or write Medtronic at the appropriate telephone number or address
listed on the back cover.
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World Headquarters
*M948278A001*
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
www.medtronic.com
Tel. +1-763-514-4000
Fax +1-763-514-4879
Medtronic USA, Inc.
Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
Bradycardia: 1-800-505-4636
Tachycardia: 1-800-723-4636
Europe/Africa/Middle East Headquarters
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
www.medtronic.com
Tel. +41-21-802-7000
Fax +41-21-802-7900
Medtronic E.C. Authorized Representative
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. +31-45-566-8000
Fax +31-45-566-8668
Technical manuals:
www.medtronic.com/manuals
© Medtronic, Inc. 2011
M948278A001B
2011-05-31
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