6
· 202104LA090207003 · 09/02/21
the RF shielded room of an ME SYSTEM for mag-
neticresonance imaging, where the intensity of
EM DISTURBANCES is high.
12
If Irregular Heartbeat (IHB) brought by com
-
mon arrhythmias is detected in the procedure
of blood pressure measurement, a
sig-
nal will be displayed. Under this condition,
the Electronic Sphygmomanometers can
keep function, but the results may not be ac-
curate, it’s suggested that you consult with
your physician for accurate assessment.
There are 2 conditions under which the signal of
IHB will be displayed:
a
The coefficient of variation (CV) of pulse
period >25%.
b
The difference of adjacent pulse period≥0.14s,
and the number of such pulse takes more than
53 percentage of the total number of pulse.
13
Please do not use the cuff other than supplied
by the manufacturer, otherwise it may bring
biocompatible hazard and might result in meas-
urement error.
14
The monitor might not meet its performance
specifications or cause safety hazard if stored
or used outside the specified temperature and
humidity ranges in specifications.
15
Please do not share the cuff with other infec
-
tive person to avoid cross-infection.
16
This equipment has been tested and found to
comply with the limits for a Class B digital de-
vice, pursuant to part 15 of the FCC Rules. These
limits are designed to provide reasonable protec-
tion 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:
a
Reorient or relocate the receiving antenna.
b
Increase the separation between the equip-
ment and receiver.
c
Connect the equipment into an outlet on a
circuit different from that to which the re
-
ceiver is connected.
d
Consult the dealer or an experienced radio/
TV technician for help.
17
Measurements are not possible in patients with
a high frequency of arrhythmias.
18
The device is not intended for use on neonates,
children or pregnant women. (Clinical testing
has not been conducted on neonates, children
or pregnant women.)
19
Motion, trembling, shivering may affect the
measurement reading.
20
The device would not apply to the patients with
poor peripheral circulation, noticeably low blood
pressure, or low body temperature (there will be
low blood flow to the measurement position).
21
The device would not apply to the patients who use
an artificial heart and lung (there will be no pulse)
22
Consult your physician before using the device for
any of the following conditions: common arrhyth-
mias such as atrial or ventricular premature beats
or atrial fibrillation, arterial sclerosis, poor per
-
fusion, diabetes, pre-eclampsia, renal diseases.
23
The patient can be an intended operator.
24
This device complies with part 15 of the FCC
Rules. Operation is subject to the following two
conditions: (1) This device may not cause harm-
ful interference, and (2) this device must accept
any interference received, including interference
that may cause undesired operation.
