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2. Cautions
2.1. General
1) DO NOT store in extremely hot, cold, humid, or wet conditions.
2) Since this product is a medical device, instructions are required to properly dispose of
it. Contact the deputy or manufacturer for such instructions. Improper disposing of this
device can lead to legal consequences.
3) Contact the manufacturer if the product functions abnormally, problematically, or not at
all. Any attempt to repair without the manufacturer's guide is not recommended.
4) Reuse of the electrodes is prohibited in any circumstances due to the infection.
5) Use of electrodes sticker may cause a skin irritation or reaction.
6) DO NOT expose to strong electromagnetic fields.
7) Too much body hair may cause an unsuccessful recording.
8) DO NOT use to diagnose heart related conditions.
9) No warranty for any data or information that is collected erroneously by the device, or
misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect, or
failure to maintain the products as instructed.
10) If there is a change in the performance of a medical device, contact the manufacturer for
action.
11) the Keep the smart phone with you to check the Sensor device status.
If the S-PATCH has no remaining storage memory or the coin cell battery drains, the
Sensor device will not continue to collect your data.
2.2. Safety
1) Before use, the doctor must explain cautions to the patient.
2) Operate the product in the correct order as described in this manual.
3) Use this device under doctor's prescription.
4) Beware of the polarity of the Coin battery when exchange and insert the battery, and the
battery certified to IEC 60086-4 or UL1642 should be used.
5) DO NOT use during magnetic resonance imaging (MRI) or external defibrillation
procedures.
6) DO NOT drop or bump with excessive force.
7) DO keep components out of reach of children.
8) DO NOT swallow the device or wind the cable around the neck.
9) Do NOT allow the cable to twist or bend.
10) Make sure that all electrodes are connected to the patient correctly before operation.
11) Conductive parts of electrodes and associated connectors for type CF applied parts,
should not contact other conductive parts including earth;
12) Do not wear device over excessive body hair in the torso area. Excessive body hair
should be removed several hours before use.
13) Do not use any lotions, oils, or powders on your chest area before or during use.
14) S-PATCH is intended to be used with FDA cleared silver/silver chloride (Ag/AgCl) ECG
electrodes supplied to a patient by a physician or recording center. ECG electrodes not
FDA cleared may cause a patient's skin to react with irritation or reddening.
Samsung Confidential
[6]
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