SELVAS Healthcare, Inc.
6
_INTRODUCTION
Note
"Notice" indicates important information 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 safety of the operator and subject and
also to the reliability of the unit.
The following precautions must be observed for additional safety;
Warning
The unit must be operated only by, or under supervision of a qualified person with our
company or our distributors.
Warning
This device is specified as Class 1 type BF unit under the standard of IEC 60601-
1:2005/A1:2012 (Basic safety and essential performance of Medical Electrical Equipment).
Therefore, patients must not touch or handle inner side of the system at any time.
Prohibition
Do not modify the unit. If any modification is needed, ask our company or its authorized
dealer for service.
Summary of Contents for ACCUNIQ BC300
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