SJM MRI ACTIVATOR HANDHELD DEVICE WORKFLOW Model: EX4000. SJM-EDTR Item approved for U.S. use only.

Transcription

1 SJM MRI ACTIVATOR HANDHELD DEVICE WORKFLOW Model: EX4000 1

2 APPROVED MRI SCAN CONDITIONS 1.5 TESLA FULL BODY 2

3 SETUP SJM MRI ACTIVATOR HANDHELD DEVICE The SJM MRI Activator handheld device must be enabled prior to using the Merlin Patient Care System (PCS). 3

4 MRI PATIENT WORKFLOW WITH SJM MRI ACTIVATOR HANDHELD DEVICE Patient needs an MRI scan Patient goes to cardiology center for device check Patient has MRI scan Patient goes home MR Saves time, effort, and inconvenience 4

5 SJM MRI ACTIVATOR HANDHELD DEVICE SJM MRI Activator Device Compatibility The SJM MRI Activator device is not paired with a specific device and can be used for all Assurity MRI pacemakers that have the SJM MRI Activator device enabled. Shelf Life 3-year battery life from manufacturing date. Activators are powered with a non-standard, non-rechargeable battery, and must be returned to St. Jude Medical for replacement. 3 years 5

6 BUTTONS AND LED INDICATOR LIGHTS Disable MRI Settings Button Enable MR Settings Button Green LED indicator lights Red LED indicator lights MRI Settings Status Request Button MR Do not use in MRI scan room 6

7 LED INDICATOR LIGHTS Color of LED Can the patient be put in MRI scanner? Cause Green Yes The pacemaker is in MRI Settings SJM MRI Activator device has not been enabled Red No Lights + Two-tone Beep No No Lead impedance readings may be out of programmed ranges so the pacemaker remains in permanent settings Notify the device clinic, physician, or St. Jude Medical representative The SJM MRI Activator device is unable to communicate with the pacemaker Reposition the SJM MRI Activator device and press the button again Notify the device clinic, physician or St. Jude Medical representative if the communication cannot be resolved 7

8 OVERVIEW 8

9 SJM MRI ACTIVATOR DEVICE WORKFLOW TO SCAN PATIENTS Step One: Verify that the patient has a St. Jude Medical MRI Conditional pacing system. 1 2 Step Two: Position the SJM MRI Activator device over the implanted pacemaker. 9

10 STEP 3: PRESS THE BUTTON TO ACTIVATE MRI SETTINGS 3 If green SJM MRI Activator device LED illuminates continuously for 5s MRI settings are ON Safe to scan the patient If red SJM MRI Activator device LED illuminates continuously for 5s DO NOT scan the patient MRI settings are OFF 10

11 STEP 4: PRESS THE BUTTON TO DISABLE MRI MODE 4 If red SJM MRI Activator device LED illuminates continuously for 5s MRI settings are OFF Safe to discharge patient If green SJM MRI Activator device LED illuminates continuously for 5s DO NOT discharge the patient MRI settings are ON 11

12 BUTTON Use the MR Status button on the SJM MRI Activator device at any time to check whether the MRI settings are on or off. 12

13 NO COMMUNICATION WITH DEVICE If the SJM MRI Activator device makes a two-tone beep, one of the following conditions may apply: It cannot communicate with the Assurity MRI pacemaker; reposition the SJM MRI Activator device. The pacemaker is not MRI conditional; contact the physician (on the ID card) or St. Jude Medical Technical Support. 13

14 SUMMARY Before the SJM MRI Activator device can be used, it must be enabled using the Merlin Patient Care System The SJM MRI Activator device is device agnostic, meaning it can be used to enable MRI settings in any Assurity MRI pacemaker that has the MRI Activator enabled in the device settings When the activator has been enabled, a clinician has already verified MRI settings that are appropriate for the patient. The activator can be used prior to the scan to enable the MRI settings stored within the device and then again after the MRI scan to return the device to the original parameter set. 14

15 DISCLAIMER Rx Only Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Indications: Dual-Chamber Pacing (Dual-chamber pulse generators, CRT-Ps) is indicated for those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and third-degree AV block, recurrent Ad ams-stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicat ed for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. MR Conditional System: MR Conditional pacemakers are conditionally safe for use in the MRI environment when used in a complete MR conditional system and according to instructions in the MRI procedure document for the St. Jude Medical MR conditional system. Contraindications: Dual-Chamber Pacing (Dual-chamber pulse generators, CRT-Ps), though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of singlechamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have d emonstrated compromise of AV conduction. For specific contraindications associated with individual modes, refer to the programmer s on-screen help. Warnings: To prevent permanent damage to the device and tissue damage at the electrode/tissue interface: Electrosurgery: Do not use electrosurgical devices in the vicinity of an implanted device. If electrocautery is necessary, use a bipolar cauterizer or place the indifferent electrode as far from the device as possible,. Lithotripsy: Do not focus a litho tripsy beam within 6 inches of the device. Program the device to Sensor Off prior to lithotripsy to prevent inappropriate increases in pacing rate. A thorough assessment of device function with special attention to the sensor should be performed following exposure to lithotripsy. Therapeutic Radiation: Do not use ionizing radiation in the vicinity of an implanted device. Radiation therapy may damage the electronic circuitry of the device. Ultrasound Treatment: Do not use therapeutic ultrasound within 6 inches of the device. Ventricular Sensing: In CRT-Ps, Ventricular Sensitivity should be programmed to the highest setting (lowest sensitivity) that will provide ventricular sensing with adequate sensing margin. Left ventricular lead dislodgement, to a position near the atria, can result in atrial oversensing and ventricular inhibition. Perform a thorough assessment of device function following exposure to any of the above. Backup VVI Operation: In rare instances, the device may revert to Backup VVI operation settings. These values are not programmable. When the device has reverted to Backup VVI operation, the programmer displays a pop-up message indicating that the device is operating at the Backup VVI values. Press [Continue] and follow the on-screen instructions. Elective Replacement Indicator (ERI): At ERI, the nominal life of the device is three or six months. When the device exhibits signs of ERI it should be replaced expeditiously. Patient follow-up visits should be scheduled at an appropriate frequency so that ERI can be detected well before End-of-Life (EOL). Noninvasive Programmed Stimulation (NIPS): Life -threatening ventricular tachycardia or fibrillation may occur during NIPS, there fore: (1) closely monitor the patient, and (2) make defibrillation and resuscitation equipment, and trained personnel, readily available during testing. Only physicians trained in tachycardia induction and reversion protocols should use NIPS. For more information on NIPS, refer to the programmer's on-screen help. Ventricular Support Pacing during NIPS testing (Dual-chamber pulse generators, CRT-Ps) is delivered in the VOO mode. The specific indications and contraindications for VOO mode can be found on the programmer s on -screen help. Precautions: For single use only. Device Communication: Communication with the device can be affected by electrical interference and strong magnetic fields. If this is a problem, turn off nearby electrical equipment or move it away from the patient and the programmer. If the problem persists, contact St. Jude Medical. Suboptimal RF Communication: For devices w ith RF telemetry capability, the Merlin PCS indicates the quality of the RF communication by the telemetry strength indicator LEDs on both the programmer and the Merlin Antenna. CT Scans: CT scans, due to their increased power leve ls and long exposure times, have the remote possibility of interfering with implanted devices. The potential interference is transient and occurs only when the X-ray signal is present. Continuous exposure may cause a temporary sensor rate increase. In addition, there is a remote possibility for a device to intermittently oversense while the CT scanning beam is directly over the implanted device. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiar ies. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies St. Jude Medical, Inc. All Rights Reserved. 15