4
5
* This device may be used only for the purpose described in this booklet. The manufacturer
and Smart Meter cannot be held liable for damage caused by an incorrect application.
INTENDED USERS AND USES CAUTIONS
* This device is intended for adult home use only.
* This device is intended for non-invasive measuring and monitoring of arterial blood
pressure. It is not intended for use on extremities other than the arm or for functions other
than obtaining a blood pressure measurement.
* The device is not suitable for use on neonatal patients, patients with implanted electronic
devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation,
peripheral arterial disease, patients undergoing intravascular therapy,
patients with an arterio-venous shunt, or mastectomy patients. Please consult your doctor
before using the unit if you suffer from these or other illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor
before using it on older children.
* Measurements performed by this device may not be accurate during pregnancy.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your
blood pressure. Do not begin or end medical treatment without asking a physician for
treatment advice.
* If you are taking medication, consult your physician to determine the most appropriate time
to measure your blood pressure. Never change prescribed medication without consulting
your physician.
* Consult your doctor if you have any questions about your blood pressure.
* When the device is used to measure patients who have common arrhythmias such as
atrial or ventricular premature beats or atrial fibrillation, the best result may occur with
deviation. Please consult your physician about the result.
* Do not apply the cuff on an arm that has other medical devices, an intravenous drip, or a
blood transfusion attached.
* Warning: Do not apply the cuff over a wound as it can cause further injury.
* This device was clinically investigated according to the requirements of ISO 81060-2.
USE ENVIRONMENT CAUTIONS
* Please use the device in the environment described in this manual. Otherwise, the
performance and lifetime of the device will be reduced.
* The device is intended for indoor home use.
* The device is not intended for use during patient transport.
* The device is not intended for public use.
* The device cannot be used with HF surgical equipment at the same time.
* The device is not AP/APG equipment and not suitable for use in the presence of a
flammable anesthetic mixture with air of oxygen or nitrous oxide.
* This unit is not suitable for continuous monitoring during medical emergencies or
operations.
INTRODUCTION
INTRODUCTION
* To avoid measurement errors, avoid electromagnetic field radiated interference signals or
electrical fast transient/burst signals.
* Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, and walkie-talkies may affect this
equipment and should be kept at least 13 feet away from the device during use. The
distance of 13 feet is calculated by the manufacturer from the 80 MHz to 5.8 GHz column
of Table 4 and Table 9 of IEC 60601-1-2, as appropriate.
* At least 30 minutes is required for the device to warm from the minimum storage
temperature until it is ready for use. At least 30 minutes is required for the device to cool
from the maximum storage temperature until it is ready for use.
* The blood pressure monitor and the cuff are suitable for use within the home
environment. If you are allergic to polyester, nylon, or plastic, please don't use this
device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been
tested and found to comply with requirements of ISO 10993-5 and ISO 10993-10. The
cuff should not cause irritation.
USE CAUTIONS
* Too frequent and consecutive measurements could cause disturbances in blood
circulation and injuries.
* When using this device, please pay attention to the following situations which may
interrupt blood flow and influence blood circulation and cause injury: connection tube
kinking, too frequent and multiple consecutive measurements, the application of the cuff
and pressurization on any arm with intravascular access therapy, where an arterio-
venous (A-V) shunt is present, and inflating the cuff on the side of a mastectomy.
* Don't compress, restrict, or kink the connection tube during use, otherwise, the cuff
pressure may continuously increase which can prevent blood flow and result in injury.
* Please check that operation of the device does not result in prolonged impairment of
blood circulation.
* If you experience discomfort during measurement, such as pain in the arm, press any
button to release the air immediately from the cuff. Loosen the cuff and remove it from
your arm.
*
If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate.
Should the cuff not deflate when the pressure reaches 40 kPa (300 mmHg), detach the
cuff from the arm immediately and press any button to stop inflation. Prolonged high
pressure (cuff pressure
＞
300 mmHg or constant pressure
＞
15 mmHg for more than 3
minutes) applied to the arm may lead to an ecchymosis.
* The operator should not touch the power supply and the patient simultaneously.
CAUTION
CAUTION
* Please report to the manufacturer and the competent authority of the Member State in
which you are established about any serious incident that has occurred in relation to this
device.
