1
/
8
Delivery package includes
Issued: 07/12/2016,
1 WIWE device
version: WIWE EN044
1 USB cable
1 User manual
1
Product description
WIWE is a cardio diagnostic device.
Item number of the white WIWE: DSW0001, item number of the black WIWE: DSW0002.
1.1
Diagnostic device
The device provides information on the average heart rate, on the possible deviation from normal ECG and on
blood-oxygen saturation
(SpO
2
) rate
. It displays arrhythmia, the risk for afib-related stroke and the deviation of the state of the heart muscle from normal. The
device also features a
pedometer
function.
1.2
Evaluation of the result, risk levels
The accurate evaluation and detailed representation of the recorded measurements are done with the help of an application that is free
to download from application stores (App Store and Google Play online stores). For the evaluation, the phone receives data from the
device via Bluetooth connection. The evaluated measurements appear on the phone’s screen showing its risk levels, and can be
forwarded to the doctor via e-mail with one tap.
1.3
Scope of WIWE.
WIWE is a measuring device that monitors the properties of the user’s cardiac activities with the help of an application that runs on
smartphones. It is a device that serves mainly for
checking the heart rhythm
– at home and on the way.
Do not use the device during driving or activities which may cause danger!
WIWE does not replace neither medical checks of heart activities, nor medical ECG recording, which can be achieved with a more
complex, multi-channel ECG measuring configuration.
WIWE will not prepare diagnosis of the potential causes based on the changes in ECG. This is exclusively reserved for your
doctor.
1.4
Accumulator
The device operates with an accumulator. The built-in accumulator can be charged with the USB cable supplied with the device
according to the charging of WIWE’s accumulator chapter.
Do not measure during charging.
2
Cautionary and safety information
2.1
General information
Adhering to the directions of the manual is essential for WIWE to function as intended, to the greatest satisfaction of the user, and
that is when you get the most accurate test result, and a safe and smooth operation.
The housing which can be accessed by the customer and the sensors are made from a biocompatible material so the occurence of
allergic reactions are not expected.
The parameters of WIWEs that are already marketed cannot be altered.
Do not change the device’s cover!
Not all cardiovascular diseases can be detected with WIWE, so if you experience any symptoms of
acute heart disease, or if you are
unsure of your symptoms – regardless of the test results of WIWE – please turn to your doctor immediately!
WIWE is meant to measure ECG in repose, that is why it is recommended to perform measuring while being still, 15-20 minutes after
heavy physical activities, when the body goes back to resting state.
WIWE displays any deviations in the heart rhythm. Among the many reasons, there can be physiological changes, which means they
can be harmless ones too, but diseases of various severity may also trigger them.
Turn to your doctor when disease is
suspected!
Those ECGs, which are recorded with WIWE reflect the momentary heart activity, thus previous or following changes may not
necessarily be detected.
Using WIWE is advised for users of 18 years or more, since the ECG of children is different from that of adults. Using WIWE does
not pose a threat to children, nor greater risk than using any other electronic device at home.
Do not perform self-diagnosis or self-treatment based on the measurement results of WIWE
without consulting your doctor.
Especially do not start a new treatment arbitrarily, and do not change the type of the existing medical treatment and the dose of
prescribed medication! We suggest that you keep the resulting ECG curves, and send or show it to your doctor, if necessary. It is
particularly true if the status messages of WIWE are not showing the normal (green) symbol.
2.2
Important safety information
ATTENTION! Some parts of the WIWE device’s case can reach 43 °C throughout the charging process. Because of this fact please
wait 5 minutes, while the device cools down to the normal temperature. Do not use WIWE while it’s charging!
ATTENTION! Danger of choking! The USB cable supplied with the device could signal “danger of choking” because of its length.
Make sure not to let children reach it.
WIWE and a defibrillator are not to be used at the same time.
Do not use the device during MRI scanning!
The pacemaker or other electronic stimulator of the user and the WIWE can be used at the same time, they do not interfere with each
other’s functioning. The doctor, however, must be aware of the presence of these devices around WIWE and has to evaluate the ECG
curve knowing this.
WIWE must be protected from radiant heat, dropping and humidity! Do not use it under water or moist environment.
Instructions for Use
Understanding and adhering to the instructions of this manual is essential so that
WIWE may show as accurate values as possible about the user’s state of health!
Web:
http://mywiwe.com/en/
1011
1413
