iHealth BP7 Manuale d'uso - Pagina 8

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d) Simultaneous use with other medical monitoring equipment on the same limb

e) The blood circulation of the user needs to be checked

This Wireless Blood Pressure Wrist 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.

4. Do not use this product in a moving vehicle as this may result in inaccurate measurements.

5. Blood pressure measurements determined by this product are equivalent to those obtained by

professional healthcare practitioners using the cuff/stethoscope auscultation method within the

limits prescribed by the American National Standard, Electronic or Automated

Sphygmomanometer.

6. 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.

7. It is recommended that the iOS device be set in Airplane mode during measurement to avoid

strong magnetism interference. If a call comes in during the measurement, the measurement

process will be terminated automatically.

8. If Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol

will be displayed. Under this condition, the Wireless Blood Pressure Wrist Monitor can keep

functioning, but the results may be inaccurate. Please consult your physician for accurate

assessment.

There are 2 conditions under which the signal of IHB will be displayed:

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 percent of the total number of pulses.

9. Please do not use any other cuff other than that supplied by the manufacturer as this may result

in measurement errors and a biocompatible hazard.

10.

This product might not meet its performance specifications if stored or used outside the

specified temperature and humidity ranges.

11.

Please do not share the cuff with any infectious person to avoid cross-infection.

12. This product should not be used as a USB device.

13. This product is verified by auscultatory method. It is recommended that you check Annex B of

ANSI/AAMI SP-10:2002+A1:2003+A2:2006 for verification method details if needed.

14. If the determined blood pressure (systolic or diastolic) is outside the rated range specified in

part SPECIFICATIONS, the app will immediately display a technical alarm on screen. In this

case, consult a physician or ensure that proper measurement procedures are followed. 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 is

non-latching and does not need to be reset.

15. A medical AC adapter with an output of DC 5.0V and complies with IEC 60601-1/UL 60601-1

and IEC 60601-1-2/EN 60601-1-2 is suitable for this monitor, such as ASP5-05010002JU

(input: 100-240V, 50/60Hz, 200mA; output: DC 5V, 1.0A). Please note that the monitor jack

size is USB mini B.