27
1) The coefficient of variation (CV) of pulse period >25%.
2) 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 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 cross-infection.
16. This equipment has been tested and found to comply with the limits for a Class B digital devi-
ce, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable pro-
tection 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:
– 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. 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 ac-
cept any interference received, including interference that may cause undesired operation.
18. Measurements are not possible in patients with a high frequency of arrhythmias.
19. 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.)
20. Motion, trembling, shivering may affect the measurement reading.
21. 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).
22. The device would not apply to the patients who use an artificial heart and lung (there will
be no pulse).
23. Consult your physician before using the device for any of the following conditions: common
arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclero-
sis, poor perfusion, diabetes, pre-eclampsia, renal diseases.
24. The patient is an intended operator.
25. Attention that changes or modification not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
