22
GICAL EQUIPMENT and the RF shielded room of an ME SYSTEM
for magneticresonance imaging, where the intensity of EM DI
STURBANCES is high.
12. If Irregular Heartbeat (IHB) brought by common arrhythmias
is detected in the procedure of blood pressure measurement, a
signal of will be displayed. Under this condition, the Elec
tronic Sphygmomanometers can keep function, but the results
may not be accurate, it’s suggested that you consult with your
physician for accurate assessment.
There are 2 conditions under which the signal of IHB will be di
splayed:
1) The coefficient of variation (CV) of pulse period >25%.
2) The difference of adjacent pulse period ≥ 0.14 s, and the num
ber 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 manufac
turer, otherwise it may bring biocompatible hazard and might
result in measurement 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 infective person to
avoid crossinfection.
16. 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 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 in
structions, may cause harmful interference to radio communica
tions. 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:
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and 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.
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 re
ading.
20. The device would not apply to the patients with poor peripheral
circulation, noticeably low blood pressure, or low body tempera
ture (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:
