SELVAS Healthcare, Inc.
6
_INTRODUCTION
Note
"Notice" indicates important information in order to notify installation, operation or
maintenance of this device. "Notice" is important but not hazard-related. Hazard warnings
are not included here.
CLASSIFICATION AND COMPLIANCE
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).
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.
Warning
During measurement of the body composition, a microcurrent of 180μA flows through
the body. Individuals who have any kind of implanted active medical devices, such as
pacemakers, should not use this equipment because the microcurrent can cause
malfunction in the implanted device.
Warning
To prevent fire hazard, use only a correctly wired (100-240VAC) outlet, and do not use a
MSO(Multiple Socket Outlet) that is not in compliance with IEC 60601-1.
Warning
To reduce the risk of electric shock or product damage, never plug-in or plug-out with
wet hands.
