Contraindication; Warning - iHealth CardioMed User Manual

Contraindication

Measurements are not possible in patients with a high frequency of arrhythmias
Do not apply the device to patients with sickle cell disease or patients who have or are expected to develop skin
lesions.
The device is not intended for use on pregnant women, neonates and children. The security and effectiveness of
the device has not been validated on pregnant women, neonates and children.
Do not apply the device to patients with coagulation disturbances.
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).

Warning

Read all of the information in the User Guide and other provided instructions before operating the unit.
Consult your physician for any of the following situations:
a)The application of the cuff on any limb with intravascular access or therapy, or an arteriovenous(A-V)
shunt.
b) The application of the cuff on the arm on the side of a mastectomy.
c) Simultaneous use with other medical monitoring equipment on the same limb.
Do not use this product in a moving vehicle as this may result in inaccurate measurements.
If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will be displayed
in the iHealth APP. Under this condition, the 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.
This product should not be used as a USB device.
If the blood pressure measurement (systolic or diastolic) is outside the rated range specified inpart
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.
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 FJ-SW328U0502000N(input:100-240V~, 50/60Hz, 0.4A
Max; output: DC 5V, 2.0A). Please note that the monitor jack size is USB micro B. The USB jack should be used
for charging only.
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.
Please do not use any cuff other than that supplied by the manufacturer as this may result in inaccurate
measurements.
The device would not apply to the patients who use an artificial heart and lung (there will be no pulse)
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, renal diseases, secondary hypertension caused by other diseases.
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