Electrode ECG adult foam hydrogel 57mm X 34mm H92SG

Instructions for use

Application area / contraindications

• Apply only according to the doctor's instructions.
• Any allergic reaction or other type of skin reaction should be immediately evaluated by a doctor.
• The product is not intended for internal use.
• In case of accidental ingestion of the electrode, consult a doctor immediately.
• It is not suitable for use in newborns or premature infants.
• Use with caution in patients with fragile skin.
• Use only in combination with cables and adapters.
• Do not let the electrodes come into contact with extreme electrical voltages.

Application

• Check the expiration date of the packaging. Do not use if out of date.
• Open the bag by the line indicated.
• Determine the application points. Remove cream, oil, gel, ointment, impurities or other layers of separation from the points of application. Otherwise, there will be no sure connection or transmission signal. If necessary, clean the skin with soap and water or other suitable preparation material and dry well before application.
• Remove the electrode from the rear protective coating.
• Place the electrodes and press the carrier material area. Press gently with your finger on the skin, exercising circular movements.
• When not yet connected, connect the patient's electrodes to the electrode connectors.

Duration of use

In case of use over several days, check daily whether the adherence is safe and the absence of skin reaction. The electrodes cannot be repositioned.

Storage

• The electrodes should be stored in their original packaging, protected from weather conditions between 10ºC and 30ºC (50ºF and 86ºF).
• After the package is opened, use the electrodes immediately.
• Protect the remaining electrodes in the package from moisture loss by folding the bag so that it is closed.

Elimination

• Dispose as household waste.
• PVD free.
• Recycle the packaging.

Warnings

Please refer to the packaging indications for the applicable RM environment conditions.

• Unsafe for RM- an item that is known to pose dangers of use in RM environments.
• RM safety information: it has been determined that the ECG electrode would be MR Conditional (it is possible to perform MR examinations, provided certain conditions are met) only when marked with the appropriate symbol.
• Do not take unsafe MR articles into the MR room. Non-clinical trials demonstrate that the ECG electrode is conditional for MRI. It is possible to safely perform the examination on a patient immediately after placing the electrodes under the following MRI examination conditions: Static magnetic field of 3.0 Tesla Magnetic field with maximum spatial gradient of 7000 Gauss/cm (70T/m) Maximum mean specific absorption rate (SAR) for the whole body, reported by the RM system, <2W/kg (Normal operating model). -Warm-up related to MRI: Under the MRI conditions defined above, the ECG electrode should produce a maximum expected temperature increase of 0.8ºC after 15 minutes of continuous examination. These temperature changes will not constitute a risk for a human being under the conditions indicated above.
• Information on artifacts: The quality of the MRI image may be compromised if the area of interest is in the same zone or relatively close to the position of the ECG electrode. Therefore, it may be necessary to optimize the MRI parameters, to compensate the presence of this device. The maximum size of the artifacts (i.e. as observed in the sequence of echo pulses or gradient) extends approximately 3.25mm in relation to the size and shape of this device.
• This product cannot be properly cleaned and/or sterilized by the user to allow safe reuse and is therefore intended for single use only. Attempts to clean or sterilize these devices may result in risks of bioincompatibility, infection or product failure for the patient.
• Do not use if the packaging is open or damaged.
• Free of natural rubber latex.
• Not produced with DEHP.
• Classified as medical device.