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When removing the EnSite™ System Reference Electrode from the patient's abdomen, remove the electrode from the patient before disconnecting
from the EnSite™ system hardware.
To reduce likelihood of skin damage when removing, slowly pull back surface electrode(s) at a low angle with one hand while holding the skin taut
with the other hand.
Do not attempt to relocate the device(s) after initial application.
Replace self-adhesive electrodes if they no longer stick firmly to the skin.
The 3M‡ Red Dot‡ Monitoring Electrode was determined to be MR-Conditional via non-clinical testing. For information on the use of a 3M‡
Red Dot‡ monitoring electrode during an MRI procedure please see below.
Limitations
Do not place the surface electrode(s) over devices such as pacemakers or ICDs.
Device(s) should only be connected to the EnSite Precision™ Cardiac Mapping System.
Adverse Events
Skin and subcutaneous tissue disorders including irritation, damage, sensitivity, burns, ecchymosis, inflammation, and allergic skin reaction.
MRI Safety Information
Important Notes
3M‡ MR Conditional EKG/ECG Electrodes have not been tested for MRI-related issues with any MR Conditional monitoring system.
Therefore, the acceptable use of 3M‡ MR Conditional EKG/ECG Electrodes when connected to an MR Conditional monitoring system is
unknown.
Disconnected 3M‡ MR Conditional Electrodes can be worn safely during an MRI examination according to the conditions of use
presented in the MRI Safety Information labeling. Any deviation from those specific conditions may result in injury (e.g., burn) to the
patient.
MR Conditional
The 3M‡ Red Dot‡ Monitoring Electrode with Foam Tape and Sticky Gel 2570 series was determined to be MR Conditional. Non-clinical testing
demonstrated that the 3M‡ Red Dot‡ Monitoring Electrode with Foam Tape and Sticky Gel 2570 series is MR Conditional. A patient with these electrodes
can be scanned safely immediately after placement under the following conditions:
Static magnetic field of 3-Tesla or less
Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4-W/kg for 15 minutes of scanning (i.e., per pulse
sequence) in the Normal Operating Mode
Under the scan conditions defined, the 3M EKG/ECG electrode is expected to produce a maximum temperature rise of 2.5°C after 15 minutes of
continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the 3M EKG/ECG electrode extends approximately 3-mm from this device when imaged using a
gradient echo pulse sequence and a 3-Tesla MR system.
NOTE: The EnSite™ Locating Electrodes and the EnSite™ System Reference Electrode have not been determined to be MR-Conditional.
Directions for Use
NOTE: Please consult the EnSite Precision™ Cardiac Mapping System IFU before using this kit.
Skin Preparation
NOTE: When prepping the skin sites for PRS patch placement, do not abrade skin.
NOTE: 3M‡ Red Dot‡ electrodes have a built-in abrader on the back of the liner that can be used to abrade skin.
Good skin preparation is essential to all electrophysiology studies. To help minimize noise related to surface electrode placement, perform these steps at
application site(s) before placing the device(s) on the patient's skin:
1.
Trim excess hair.
2.
Gently abrade the skin using a gauze pad or like material or gel prep (such as Omni Prep) that contains small particles of gritty material. Make sure
all the gel material is removed from the skin.
3.
Clean skin surface with soap and water. Avoid cleaning with isopropyl alcohol unless the skin is excessively oily or covered with lotion.
4.
Ensure the skin is completely dry and that all alcohol has evaporated.
Placement Guidelines
When placing the EnSite Precision™ Surface Electrodes on the patient, it is important to place them in the correct position, not only in relationship to
each other, but also in relationship to other surface electrodes.
It is recommended to avoid opening the package and removing the liner until the surface electrode is ready to be placed on the patient. Once the liner
has been removed, do not attempt to stick the liner back on the adhesive side of the surface electrode. Doing so may result in the liner becoming stuck
to the surface electrode.
Front (Anterior) and Back (Posterior) Electrodes
The precordial lead V2 ECG electrode placement at the 4th intercostal space and the left sternal border guides the placement of the anterior
EnSite Precision™ Surface Electrode. If both are placed correctly, the anterior EnSite Precision™ Surface Electrode will be offset slightly to the left of the
patient's sternum. It is important that the posterior EnSite Precision™ Surface Electrode be placed directly opposite of the anterior EnSite Precision™
Surface Electrode. As a result, it should be offset slightly to the left of the patient's spine. This placement will help maintain appropriate anteroposterior
(AP) orientation. Deviation from the recommended location will skew the AP orientation in the map display.
Right and Left Electrodes
The right and left side EnSite Precision™ Surface Electrodes must also be directly across from each other and orthogonal to the AP surface electrode
arrangement. Any other placement may skew side-to-side orientation.
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