3.5.2 Statement
• The unit is intended to be used to measure blood pressure (systolic and
diastolic) and heart rate from the upper arm by using the oscillometric method.
• The unit is intended for using in only adult population, not applied to the other
populations such as newborn babies.
•It can’t be used while the arm has bleeding or wound to avoid the blood
flowing from the wound when pressurizing.
•The device's accessories and batteries should be disposed of as waste correctly
at the end of its service life, please follow Local Laws or Regulations for disposal.
•Applied part: CUFF.
Protection Class: Internally powered equipment.
•Applied Part Type: Type BF.
Moisture Protection: IP21, continue operation.
Altitude<2000m;
Overvoltage:II;
Pollution degree:2
•The risk of patient and user can be lowered to an acceptable level.
•The unit might not meet its performance specification if stored or used outside
the following specified temperature , humidity and altitude ranges.
•The unit satisfies the requirements of IEC60601-1 Medical electrical equipment,
IEC 60601-1-2: Electromagnetic compatibility –Requirements and tests
IEC 80601-2-30: Non-invasive sphygmomanometers - Part 1: Requirements and
test methods for non-automated measurement type EN1060-3: Non-invasive
sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring
systems.
3.5.3 IEC 60601-1-2:2014 ME EQUIPMENT and ME SYSTEMS identication, marking
and documents for Class B product
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
and so on.
Warning:Don’t near active HF surgical equipment and the RF shielded room of an
ME system for magnetic resonance imaging, where the intensity of EM
disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified
or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
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