User's Manual

Appendix
 Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environments listed below, and should only be
used in such environments:
Emissions test Compliance
Electromagnetic environment –
guidance
RF emissions
CISPR 11
Group 1
RF energy is used only to maintain device’s
operation. Therefore, its RF emissions are so
low that it’s not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The device is suitable for use in all
establishments, including domestic
establishments, and those directly connected
to the public low-voltage power supply
network
that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Complies
 Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and should only be
used in such environments:
HL858DC essential performance per IEC 80601-2-30 additional
essential performance requirements:
 201.12.1.102 Limits of the error of the manometer from
environmental conditions
Over the temperature range of 5 °C to 40 °C (41 °F ~ 104 °F ) and
the relative humidity range of 15 % to 93 %(non-condensing), the
maximum error for the measurement of the CUFF pressure at any
point of the NOMINAL measurement range shall be less than or
equal to ± 3 mmHg (± 0.4 kPa) or 2 % of the reading, whichever is
greater.
 201.12.1.107 Limits of the change in error of the blood
pressure determination
The laboratory limits of the change in error of the BLOOD PRESSURE
DETERMINATION of the AUTOMATED SPHYGMOMANOMETER shall be
less than 3 mmHg (0.4 kPa).
Note
*Note ！
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in
a residential installation.
This equipment generates uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following measures:
The user is encouraged to try to correct the interference by one or more of the following measures:
 Reorient or relocate the receiving antenna.
 Increase the separation between the equipment and the receiver.
 Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
 Consult the dealer or an experienced radio/TV technician for help.
CAUTION:
To assure continued FCC compliance:
1. Any changes or modifications not expressly approved by the grantee of this device could void the user's
authority to operate the equipment.
2. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
FCC Label Compliance Statement:
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired
operation.
*Note
！
“Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate
the equipment”.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 15 kV air
The relative humidity should be at least 5
%.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 30 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Recommended separation distance
I
r =
────
(m)
188
where I is the current in amperes in a
power bus or an appliance wire and r is
the recommended separation distance
between your device and the power bus or
appliance wire, in meters (m).
Electrical fast
transient/burst
IEC 61000-4-4
±
2 kV for power supply
lines
± 1 kV for input/output
lines
±
2 kV for power supply
lines
± 1 kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±
1 kV line(s) to line(s)
± 2 kV line(s) to earth
±
1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be that of a
typical commercial or hospital
environment.
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the device
requires continued operation during
power mains interruptions, it is
recommended that the device be powered
from an uninterruptible power supply or a
battery.
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