Mobiclinic TX-01 - Page 17

Blood Pressure Monitor
FR IT DE PT NL
SWE
PL DKENES
17
NOTICE
Notice to the user and/or patient: any serious incident which has occurred in connection
with the device must be reported to the manufacturer and to the competent authority of the
Member State in which the user and/or patient is established.
WARNINGS
1. Read all information in the operating guide and any other literature in the box before
operating the unit.
2. Remain still and at rest for 5 minutes before measuring blood pressure.
3. The cu should be placed at the same level as your heart.
4. During the measurement, do not talk or move your body or arm.
5. Measure on the same arm for each measurement.
6. Please always relax for at least 1 to 1.5 minutes between measurements to allow the blood
circulation in your arm to recover. Prolonged overination (cu pressure exceeds 300 mmHg or
remains above 15 mmHg for more than 3 minutes) of the chamber may cause an echymoma
in your arm.
7. Consult your physician if you are in any doubt about the following cases:
1) Applying the cu to a wound or illness with inammation.
2) Application of the cu to any extremity where there is an intravascular access or therapy,
or an arteriovenous (A - V) shunt.
3) Application of the cu to the arm on the side of a mastectomy or lymph node clearance.
4) Used simultaneously with other monitoring equipment on the same extremity.
5) Required to monitor the user’s blood circulation.
8. Do not use this unit in a moving vehicle, as this may result in erroneous measurements being
obtained.
9. This electronic sphygmomanometer is designed for adults and should never be used
on infants or young children. Consult your physician or other health care professionals
before use on older children.
10. Blood pressure measurements determined by this monitor are equivalent to those
obtained by a trained observer using the cu/stethoscope auscultation method, within the
limits prescribed by the American National Standards Institute, for electronic or automated
sphygmomanometers.
11. Information regarding possible electromagnetic or other interference between the
blood pressure monitor and other devices, along with recommendations for avoiding such
interference, is provided in the ELECTROMAGNETIC COMPATIBILITY INFORMATION section. It
is suggested that the blood pressure monitor be kept at least 30 cm away from other wireless
devices, such as WLAN unit, microwave oven, etc. It cannot be used near active HF SURGICAL
EQUIPMENT and the RF shielded room of a ME SYSTEM for magnetic resonance imaging,
where the intensity of EM DISTURBANCE is high.
12. If irregular heartbeats (IHB) caused by common arrhythmias are detected in the blood
pressure measurement procedure, a signal shall be displayed . In this condition, electronic
sphygmomanometers can maintain their functions, but the results may not be accurate, so it is
suggested that you consult your physician for an accurate evaluation.
There are two conditions under which the signal (IHB) will appear:
1) Coecient of variation (CV) of pulse period >25%.
2) Dierence in adjacent pulse period ≥0.14s, and the number of that pulse takes more than
53% of the total pulse number.