MRI Conditional....Don't make me laugh.!

Anonymous

Guest
Restrictions for the patient and the cardiac device system
The implanted system consists only of a lead and a pacemaker, which are each labeled
MR Conditional separately, and in combination make up an MR Conditional system.
There are no other implants in the patient’s body. For example:
Other pacemakers or ICDs
Leads no longer in use
Lead adapters
Lead extensions
The patient does not have fever.
The patient’s height is at least 1.4 meters.
The system has been implanted for at least 6 weeks.
The implanted pacing system is in the patient’s chest area.
The calculated pacing threshold does not lie above 2.0 V amplitude at 0.4 ms pulse width.
The ascertained lead impedance is between 200 and 1500 Ohms.
The implant is programmed to a special MRI mode immediately before the MRI scan.
The conditions applicable to specific devices or systems such as specific permissible
positioning zones, minimum patient height, etc. are adhered to.
Requirements of the MRI scanner
Use of a clinical MRI machine with
A closed tube
Cylindrical magnets
A static magnetic field strength of 1.5 Tesla.
The slew rate of the MRI scanner’s gradient fields should not exceed 216 T/m/s.
No additional local transmitting coils are used.
Restrictions during the MRI scan
The MRI scan can only be performed with the patient in dorsal position.
The permissible positioning zone defined below has to be adhered to.
The overall MRI scanning time accumulated from the imaging times as displayed by
the MRI scanner must not exceed 30 minutes.
The mean specific absorption rate for the whole body displayed by the MRI scanner
must not exceed 2.0 W/kg.
The head absorption rate displayed by the MRI scanner must not exceed 3.2 W/kg.
Emergency equipment for reanimation must be kept at hand and properly certified staff
must be available.
Monitor the patient’s hemodynamics during the entire MRI scan by continuously
recording at least one of the following parameters:
Blood oxygen saturation
Blood pressure
ECG

Starting from the foot end, the maximum allowed positioning mark
for the isocenter (laser light) is at the hip bone level.
Starting from the top of the skull, the maximum allowed positioning
mark for the isocenter is at the level of the eyes.
 






Restrictions for the patient and the cardiac device system
The implanted system consists only of a lead and a pacemaker, which are each labeled
MR Conditional separately, and in combination make up an MR Conditional system.
There are no other implants in the patient’s body. For example:
Other pacemakers or ICDs
Leads no longer in use
Lead adapters
Lead extensions
The patient does not have fever.
The patient’s height is at least 1.4 meters.
The system has been implanted for at least 6 weeks.
The implanted pacing system is in the patient’s chest area.
The calculated pacing threshold does not lie above 2.0 V amplitude at 0.4 ms pulse width.
The ascertained lead impedance is between 200 and 1500 Ohms.
The implant is programmed to a special MRI mode immediately before the MRI scan.
The conditions applicable to specific devices or systems such as specific permissible
positioning zones, minimum patient height, etc. are adhered to.
Requirements of the MRI scanner
Use of a clinical MRI machine with
A closed tube
Cylindrical magnets
A static magnetic field strength of 1.5 Tesla.
The slew rate of the MRI scanner’s gradient fields should not exceed 216 T/m/s.
No additional local transmitting coils are used.
Restrictions during the MRI scan
The MRI scan can only be performed with the patient in dorsal position.
The permissible positioning zone defined below has to be adhered to.
The overall MRI scanning time accumulated from the imaging times as displayed by
the MRI scanner must not exceed 30 minutes.
The mean specific absorption rate for the whole body displayed by the MRI scanner
must not exceed 2.0 W/kg.
The head absorption rate displayed by the MRI scanner must not exceed 3.2 W/kg.
Emergency equipment for reanimation must be kept at hand and properly certified staff
must be available.
Monitor the patient’s hemodynamics during the entire MRI scan by continuously
recording at least one of the following parameters:
Blood oxygen saturation
Blood pressure
ECG

Starting from the foot end, the maximum allowed positioning mark
for the isocenter (laser light) is at the hip bone level.
Starting from the top of the skull, the maximum allowed positioning
mark for the isocenter is at the level of the eyes.



Where did you find this?
 


















I guess this is funny too.






MRI conditions for use

A complete SureScan pacing system including a Revo 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.

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 the Revo MRI SureScan Pacing System Technical Manual.

The SureScan pacing system can be scanned in patients under the following conditions:

1. Horizontal, cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) must be used.

2. Gradient systems with maximum gradient slew rate performance per axis of ≤ 200 Teslas per meter per second (T/m/s) must be used.

3. The scanner must be in Normal Operating Mode:
• Whole body averaged specific absorption rate (SAR) as reported by the MRI equipment must be ≤ 2.0 Watts per kilogram (W/kg)
• The head SAR must be < 3.2 W/kg.

4. 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.

5. 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).

6. 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 the left or right pectoral region
• pacing capture threshold values of ≤ 2.0 volts (V) at a pulse width of 0.4 milliseconds (ms)
• a lead impedance value of ≥ 200 ohms (Ω) or ≤ 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

7. A health professional who has completed cardiology SureScan training must be present during the programming of the SureScan feature.

8. A health professional who has completed radiology SureScan training must be present during the MRI scan.

9. The implanted system must consist solely of a SureScan device and SureScan leads. Any other combination may result in a hazard to the patient during MRI scans.

For more information please visit http://www.medtronic.com/mrisurescan

[MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MR procedure.]

REFERENCES

http://www.medtronic.com/mrisurescan

Instructions for Use, SURESCAN MRI procedural information for Revo MRI SureScan RVDR01, CapSureFix MRI 5086MRI, Medtronic, Inc., Minneapolis, MN

Sutton R, Kanal E, Wilkoff BL, et al. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. 2008 Dec 2;9:68.