Contraindications
1) Do not use if you have current symptoms or medical history of skin cancer, rash, dermatosis, keloids, wounds, etc.
2) Do not use patients with cardiac pacemakers, cardiac defibrillators or other implantable electrical devices.
3) Not for use on pregnant women, breastfeeding mothers, infants or children.
Adverse Event
Physician should advise patients to seek medical attention if either of the following occurs.
1) Mild rash
2) Allergic reaction
3) Skin irritation
4) Itchiness
Warnings
1) This product is for single use only. Reuse is prohibited. Reusing it may lead to malfunction and inaccurate results.
2) Do not attach to any other place than the recommended bodily location of Application.
3) Only authorized technicians are allowed to repair or disassemble Device.
4) Make sure to be fully aware of how to use the product, through sufficient training, before using it.
5) Avoid use at locations where wireless communication interference may occur (e.g., places where metallic hardware or electronic
devices are frequently found).
6) This product cannot be simultaneously used with a defibrillator.
7) Do not expose to strong electromagnetic fields.
8) The device should not be used adjacent to or stacked with other equipment.
9) The device may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSIONS requirements.
10) Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the device. Otherwise, degradation of the performance of this equipment could result.
11) Cautions should be communicated to the patient.
12) All serious accidents related to the medical devices should be reported to the health authorities of the Member State where the
manufacturer, user and patient are located.
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Caution
Appendix
04
Precaution
1) Inappropriate Application and use of the sensor may result in inaccurate measurements, please avoid the below.
- Excessive movement of the patient.
- Application outside the recommended bodily locations.
- To prevent signal abnormalities due to the state of the patient’s skin, sufficient notice of use from physician must be obtained
before use.
2) The following persons should consult physician before using the device.
- Patients with sensitive skin or skin allergy.
- Patients with wounds on the skin that contact the device.
3) Take caution to avoid getting liquid in the device, and also avoid the following.
- Long-term exposure to water such as baths, swimming, etc.
4) Avoid letting the device come into contact with organic compounds like thinners or benzene.
5) Beware of strong shocks and vibrations.
6) Once the product is detached from the body, do not reattach it.
7) The smartphone on which the App is run must be one with a test report or a certificate issued by national or accredited offices.
8) The device needs special precautions regarding EMC and needs to be utilized according to the EMC information provided in the
Electrical safety and compatibility section.
9) Portable and mobile RF communications equipment can affect medical electrical equipment.
10) If the device stops in the middle, see physician.
11) Measures to be taken when a cybersecurity issue occurs.,
- The manufacturer should be consulted if a cybersecurity issue occurs.
ATsens Co., Ltd. : Tel. +82 70 5220 0220 / Fax. +82 70 8270 0738 / E-mail.
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Appendix
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