SELVAS Healthcare
User Manual BC380
4
_Introduction
INTRODUCTION
You are kindly requested to be familiar with these directions before using this device and always keep it
together with the device. In case you are not sure about any directions or problems arising while using the
device, please contact with SELVAS Healthcare or its local distributor where is purchased. We will provide
you with detailed instructions.
INTENDED USE
This device measures impedance by bioelectrical impedance analysis method and provides lots of
information using measured impedance and inputted personal data (height, age, gender, weight).
It shows body composition of MBF, LBM, SLM, SMM, TBW, protein mass, mineral mass, etc. and information
regarding BMI, PBF, BMR, abdominal analysis, Target to control, segmental analysis, Body composition
change, etc.
Intended application location is professional healthcare facility environments, not home healthcare
environment.
CONTRAINDICATIONS
The device should not be used in following people:
･
Anyone who implants metallic materials like a pacemaker, defibrillator, stent, and metal suture in the
heart and great vessel etc.
･
Anyone who is equipped with the devices injecting electric current such as artificial heart, and heart
lung machine.
･
Anyone who is connected to liquid-filled catheter and other electronic devices of good conductivity.
･
Anyone who use following device can go into danger or cannot reach objective result due to
interference with other electric signals.
Using electronic stimulator for various purposes.
･
Devices injecting electric current or connecting and operating: ECG, EMG, and EEG.
･
Any other person who is diagnosed by the doctor to be influenced even by imperceptible micro-current.
Please consult with doctor before using this device to:
･
Any woman with contraceptive devices.
･
Any woman in pregnancy.
INTENDED PATIENT POPULATION
･
Age: No limit
･
Gender: No limit
･
Weight: 10 ~ 250 Kg
･
Height: 50 ~ 220 cm
･
Race: No special requirements
･
Health: A person who can stand up and maintain the measurement posture required by the machine.
WORD DEFINITIONS
To ensure safe operation and long term performance stability, it is essential that you fully understand the
functions, operating and maintenance instructions by reading this manual before operating your unit.
Particular attention must be paid to all warnings, cautions and notes incorporated herein.
The following conventions are used throughout the manual to denote information of special emphasis.
Warning
“Warning” indicates important information about the presence of a hazard which may
cause severe personal injury, loss of substantial property, damage if the warning is
ignored.
Caution
“Caution” indicates important information about the presence of a hazard which may
cause minor personal injury or property damage if the caution is ignored.
Note
“Note” indicates important information in order to notify installation, operation or
maintenance of this device. "Note" is important but not hazard-related.
Hazard warnings are not included here.
Introduction_
5
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).
Introduction
Содержание BC 380
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