SELVAS Healthcare
User Manual BC380
8
_Introduction
Introduction
Introduction_
9
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 device damage, never plug-in or plug-out with
wet hands.
Warning
Physically disabled persons should not attempt to take measurements alone, but instead
should have their caretakers assist them in using the device.
Caution
The unit must be operated only by, or under supervision of a qualified person with our
company or our distributors.
Caution
If you have experienced any trouble with the unit, switch it off immediately, and contact
our company or its authorized dealer for assistance.
Caution
If you plan to connect any device from other manufacturers electrically or mechanically to
the unit, contact our company or its authorized dealer for instructions before doing so.
When you connect computer or other system to the unit (RS-232C), the attached systems
should be those certified by IEC 950 or equivalent standards for data processing equipment.
Configurations shall comply with the system standard IEC 60601-1:2005/A1:2012.
Everybody who connects additional equipment to the signal input part or signal output
part configures a medical system by standard IEC 60601-1:2005/A1:2012.
If in doubt, consult the A/S department of local distributor.
Caution
Avoid the following environments for storage;
･
Where the ambient temperature falls below -25℃ or exceeds 70℃.
･
Where the atmospheric pressure falls below 70kPa (700mbar) or exceeds 106kPa (1060mbar).
･
Where the humidity is over 93% non-condensing.
･
Where the unit is exposed to spray or splashing water.
･
Where the unit is exposed to dust.
･
Where the unit is exposed to water vapor.
･
Where the unit is exposed to salty atmosphere.
･
Where the unit is exposed to explosive gas.
･
Where the unit is exposed to excessive shocks or vibrations.
･
Where the angle of inclination of mounting surface exceeds 10 degrees.
･
Where the unit is exposed to direct sunlight.
Caution
This device needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided in the ACCOMPANYING
DOCUMENTS.
Caution
Cross contamination is possible because this equipment is used with bare hands and
feet. Refer to the cleaning and disinfecting methods in this manual.
Caution
Measurements may be impaired if this device is used near televisions, microwave
ovens, X-ray equipment or other devices with strong electrical fields. To prevent such
interference, use the meter at a sufficient distance from such devices or turn them off.
Prohibition
Do not disassemble or alter the device under any circumstances, as this could result in
electric shock or injury as well as adversely affect the precision of measurements. This
device is specified as Class 1 type BF unit under the standard 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 to touch signal input, signal output or other connectors, and the patient
simultaneously.
Содержание BC 380
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