7
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14
5. If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will be displayed in
the “iHealth MyVitals” APP. Under this condition, the Wireless Blood Pressure Monitor can keep functioning, but the
results may be inaccurate. Please consult your physician for accurate assessment.
The IHB symbol will be displayed under 2 conditions:
1) The coefficient of variation (CV) of pulse period >25%.
2) The difference of adjacent pulse period is ≥0.14s and more than 53 percent of the total number of pulses readings
falls within this definition.
6. Please do not use any cuff other than that supplied by the manufacturer as this may result in inaccurate
measurements.
7. For information regarding potential electromagnetic or other interference between the blood pressure monitor and
other devices together with advice regarding avoidance of such interference, please see ELECTROMAGNETIC
COMPATIBILITY INFORMATION. It is suggested that the blood pressure monitor be kept 10 meters away from other
wireless devices, such as WLAN unit, cell phone, microwave oven, etc.
8.This product should not be used as a USB device.
9. If the blood pressure measurement (systolic or diastolic)is outside the rated range specified in part
SPECIFICATIONS, the monitor will immediately display a technical alarm on the LED screen. In this case, repeat the
measurement ensuring that the proper measurement procedures are followed and/or consult with your medical
professional. The technical alarm is preset in the factory and cannot be adjusted or inactivated. This technical alarm is
assigned as low priority according to IEC 60601-1-8. The technical alarm does not need to be reset.
10. This device requires a medical AC adapter with an output of DC 5.0V that complies with IEC60601-1/UL 60601-1
and IEC 60601-1-2/EN 60601-1-2 such as UE05WCP-050100SPC(input:100-240V, 50/60Hz, 0.18A; output: DC 5V,
1.0A). Please note that the monitor jack size is USB microAB. The USB jack should be used for charging only.
11.Use of Charging Cable other than those specified or provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper
operation.
12.Measurements are not possible in patients with a high frequency of arrhythmias.
13.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.)
14.Motion, trembling, shivering may affect the measurement reading.
15.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).
16.The device would not apply to the patients who use an artificial heart and lung (there will be no pulse)
17.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 sclerosis, poor perfusion, diabetes, pre-eclampsia, enal
diseases.
18.The patient is an intended operator.
This Monitor is designed for adults and should never be used on infants, young children, pregnant or
pre-eclamptic patients. Consult your physician before use on children.
This product might not meet its performance specifications if stored or used outside the specified temperature and
humidity ranges.
Please do not share the cuff with any infectious person to avoid cross-infection.
Please do not attempt to open or disassemble the product, under inappropriate operation, the device and battery can
be damaged and hazardous to the human body and the environment.
