6
3
Safety Information
3.1
Contraindications
1)
Patients with implantable cardiac pacemaker, cardioverter defibrillator, or
other implantable electric devices.
2)
Pregnant women or breast-feeding mothers.
3)
Patients with current symptoms or medical history of skin cancer, rash, skin
disorder, keloid, and/or any injury.
3.2
Warnings
3.2.1
General
1)
Before using external defibrillator, remove S-Patch Ex from patient body
2)
DO NOT swallow the device or wind the cable around the neck. Keep
components out of reach of children.
3.3
Cautions
3.3.1
General
1)
A healthcare professional should explain the proper use of the device to a
patient.
Use this device under doctor’s prescription.
2)
Follow instructions specified in Section 4.3.2 for proper storage of the product
3)
A new lithium coin battery must be used for each use. Make sure the battery is
inserted in the correct orientation
4)
Do not use dried out electrodes. Do not re-use electrodes. New electrodes must
be used for each use.
5)
Do not place the device on top of excessive body hair. Excessive body hair may
cause noise in the recording. Body hair should be removed prior to placement
of the device.
6)
Do not drop or bump with excessive force.
7)
After completing the testing, peel the S-Patch Ex off the skin. Prolonged use of
electrodes may cause skin irritation. Discontinue use and consult your
healthcare provider if skin irritation occurs.
8)
Please follow local laws for disposal of battery and/or electronic products.
9)
Contact the manufacturer if there is a change in the performance of the device.
10)
No warranty is provided for any erroneous data collected by the device due to
misuse or malfunction as a result of abuse, accidents, alteration, neglect, or
failure to maintain the products as instructed.
3.3.2
MR-unsafe
1)
Do not expose the device to a magnetic resonance (MR) environment due to
the following:
⚫
The device may present a risk of projectile injury due to the presence of
ferromagnetic materials that can be attracted by the MR magnet core.
⚫
Thermal injury and burns may occur due to the metal components of the
device that can heat during MR scanning.
Summary of Contents for S-Patch Ex
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