1) This device is classified as;
- Class 1 type-BF against electric shock
- Ordinary equipment without protection against ingress of water
- Equipment not suitable for use in presence of a flammable anesthetic mixture by standard of
IEC 60601-1: 2005+A1:2012(Basic safety and essential performance of Medical Electrical Equipment)
2) This device is complied with Class A for Noise-Emission, Level B for Noise-immunity, by standard of IEC 60601-1-2:2014(Electromagnetic Compatibility Requirements).
4. SAFETY PRECAUTIONS
This device is designed and manufactured with consideration of the safety of the operator and subject and also the reliability of the unit. The following warnings, precautions and notes must be observed for safety;
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The unit must be operated only by, or under supervision of a qualified person with our
company or our distributors.
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5
CLASSIFICATION AND COMPLIANCE