Statement; Emc Table; Specifications - Quoticare BP101U Instruction Manual

Statement

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 usingin only adult population,not applied
to the other populations such as neonatal baby.
It can't be used while the wirst (arm) has bleeding or wound to
avoid the blood flowing from the wound in pressurzing.
The device,part and batteries have to be disposed of waste correctly at
the end of the usage.
Please follow Local Ordinances or Regulations for disposal.
Applied part: CUFF.
Protection Class: Internally powered equipment.
Applied Part Type: Type BF.
Moisture Protection: IPX0,continue operation.
altitude<2000m;
overvoltage:II;
pollution degree:2
The risk of patient and user can be lowered to 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 60601-1-2:2007: Electromagnetic compatibility –Requirements
and tests
IEC80601-2-30:Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type
EN 1060-3:Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure
measuring systems
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EMC Table

EMC Table
Guidance and manufacture's declaration Guidance and manufacture's declaration
Guidance and manufacture's declaration – electromagnetic emission Guidance and manufacture's declaration – electromagnetic emission
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment
specified below. The customer of the user of the Digital Blood Pressure Monitor should
assure that it is used in such an environment.
Emission test Emission test Compliance Compliance Electromagnetic environment – guidance Electromagnetic environment – guidance
The Digital Blood Pressure Monitor use RF energy only for
RF emissions its internal function. Therefore, its RF emissions are very low
Group 1
and are not likely to cause any interference in nearby
CISPR 11
electronic equipment.
RF emission
Class B
CISPR 11
Harmonic
The Digital Blood Pressure Monitor is suitable for use in all
emissions Not applicable
establishments other than domestic and those directly
IEC 61000-3-2
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Voltage
fluctuations/
Not applicable
flicker emissions
IEC 61000-3-3
Guidance and manufacture's declaration – electromagnetic immunity Guidance and manufacture's declaration – electromagnetic immunity
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of Digital Blood Pressure Monitor should assure
that it is used in such an environment.
IEC 60601 test IEC 60601 test Compliance Compliance
Immunity test Immunity test
level level level level
Electrostatic
±6 kV contact ±6 kV contact
discharge (ESD)
±8 kV air ±8 kV air
IEC 61000-4-2
Power frequency
(50Hz/60Hz)
3V/m 3V/m
magnetic field IEC
61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacture's declaration – electromagnetic immunity Guidance and manufacture's declaration – electromagnetic immunity
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of Digital Blood Pressure Monitor should assure
that it is used in such an environment.
Electromagnetic environment - guidance Electromagnetic environment - guidance
Floors should be wood, concrete or
ceramic tile. If floor are covered with
synthetic material, the relative humidity
should be at least 30%.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
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