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AILE FC-BP131 - Intended Use and Contraindications

AILE FC-BP131
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4
■ Please do not put CUFF over a wound, as this can cause further
injury;
■ Regarding the effect of blood flow interference and resulting
harmful injury to the PATIENT caused by continuous CUFF pressure due
to connection tubing kinking;
■ StatementRegarding the requirements of the adapter, it should
meet the following conditions, output voltage: DC 5V, Current: 1000mA,
and comply with IEC 60601-1 and IEC 60601-1-11, provide two MOPP
insulation between ac input and dc output.
■ Do not install the wrong battery polarity.
■ After the battery is exhausted, please replace four new batteries.
■ If over three months do not use the device, please remove the
battery as it may cause leakage, overheat, rupture and damage the
blood pressure monitor body.
Intended purpose: The Upper Arm Electronic Blood Pressure Monitor is
intended used to measure the systolic and diastolic blood pressure
and pulse rate of an adult individual by using a non-invasive technique
in which an inflatable cuff is wrapped around the upper arm.
Indication: Intermittent measurement of human body blood pressure
from upper arm.
Contraindications:
● The product can not be used for patients with arrhythmia.
● This product can not be used for infants, neonates or pregnancy.
● People who can not express himself can not use this product.
Intended users: Professional medical staff, lay persons.
Patient population: Adults.
Clinical benefits: Measuring body blood pressure so as to help to
diagnose human body conditions.

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