MRI Procedure Information - SJM

Allure™, Allure™ RF, Allure Quadra™, Allure Quadra™ RF ...

Testing has demonstrated that the St. Jude Medical™ MR Conditional pacing system is conditionally safe for use in the MRI environment when used according to the instructions in the MRI Procedure Information document. The St. Jude Medical MR Conditional pacing system includes a St. Jude Medical MR Conditional pulse generator

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MRI-Ready Systems Manual - St. Jude Medical Instructions ...

The St. Jude Medical MR Conditional system includes a St. Jude Medical MR Conditional device connected to one or more St. Jude Medical MR Conditional leads. For a list of the device/lead combinations that have been tested, see the device/lead combinations tables (page . …

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Tendril STS 2088 [OUS] - St. Jude Medical Instructions for ...

1. Inside sterile field : Sterilization The package contents have been sterilized with ethylene oxide before shipment. This lead is for single use only and is not intended to be resterilized. If the sterile package has been compromised, contact St. Jude Medical. Implanting the Tendril™ STS Lead : Pre-Implantation : Before implanting the lead:

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User's Manual - St. Jude Medical Instructions for Use Website

The device and the incision and insertion tools have been sterilized with ethylene oxide prior to shipment. They are intended for single use only and should not be resterilized. If the sterile package has been compromised, contact St. Jude Medical. Do not insert the device if the dot on the ethylene oxide label is purple.

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MR Conditional. Refer to the MRI Safety Information ...

suture markers to facilitate valve placement. A stainless steel wire is located under ... • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature ... The clinical investigation of the Epic valve supports the safety and effectiveness of

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User's Manual - SJM

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 lithotripsy beam within 16 cm of the device. Program the device to

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User's Guide - SJM

The St. Jude Medical™ Patient Controller app is intended to be used with the generator to help the patient manage prescribed stimulation programs. Indications for Use . This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral

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Ellipse Fortify Assura - SJM

Additional pacemaker implanted. These devices provide bradycardia pacing. If another pacemaker is used, it should have a bipolar pacing reset mode and be programmed for bipolar pacing to minimize the pos sibility of the output pulses being detected by the device. Modifying the device. This device has been tested for compliance to FCC regulations.

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MRI-Ready Systems Manual - SJM

an MRI scanner when used according to the instructions in this manual. CAUTION Not all of the products listed as MR Conditional are approved for MR Conditional use in all countries or regions. Before performing an MRI scan on patients implanted with …

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MRI Ready Monitor Systems Manual - SJM

During the MRI scan, visually and audibly monitor the patient, including verbal communication. The following potential effects during the scan should be considered: When selecting the field of view and imaging parameters, consider that image distortion may occur around the ICM. Consider these factors also when interpreting the MRI images.

The Municipal Planning Guide to Zoning Bylaws in Manitoba

2. Prescribe permitted and conditional uses for land and buildings in each zone. 3. Establish a system of development permits and procedures [71(1)]. See Part 2 of The Introduction for more information on these three requirements of a zoning bylaw. In addition to these requirements, a zoning bylaw must also “prescribe general

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ImageReadyTM MR-Conditional Model List

TM MR-Conditional* Model List* Therapy Device Name Device Model Numbers MRI System Configuration ICM LUX-Dx™ M301 1.5T or 3T Pacemakers ACCOLADE™ MRI ESSENTIO™ MRI 1.5T or 3T L310, L311, L331 L110, L111, L131 VITALIO™ MRI1 K275, K277 1.5T S-ICD EMBLEM™ A209 1.5T EMBLEM™MRI A219

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Agreement for Bringing Peace to Afghanistan as a state and ...

Feb 29, 2020 · II A. The United States, its allies, and the Coalition will take the following measures in the first one hundred thirty-five (135) days: 1) They will reduce the number of U.S. forces in Afghanistan to eight thousand six hundred

  Agreement

Cardiology Order Form - Boston Scientific

Patient is implanted with a valid ImageReady™ MR-Conditional Pacing System. Pulse generator implant location is left or right pectoral region. At least six (6) weeks have elapsed since implantation and/or any lead revision or surgical modification of …

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AZURE™ MRI SURESCAN™ / ASTRA™ MRI SURESCAN™ MRI …

The Medtronic 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.

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MRI Ready Monitor Systems Manual - SJM

WARNING: Scanning patients who have other MR Conditional devices is acceptable as long as all the MR Conditional requirements for each of the implanted devices are met. Do not conduct an MRI scan if any conditions or implants prohibit it. If you are unclear what implants are present, perform an X-ray to determine the implant type and location.

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事 務 連 絡 令和元年11月15日 厚生労働 ... - Pmda

るMR安全性評価等、添付文書における記載方法及び経過措置等の取扱いに関する質疑応 ... Q11：「MR Safe」、「MR Unsafe」、「MR Conditional」を別の用語に置き換えるなど、二課 …

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