1.
The Basics
Caution: Federal law restricts this device to sale by or on the order of a physician.
This manual contains the instructions necessary to operate the product safely and in accordance with its
function and intended use. Observance of this manual is a prerequisite for proper product performance and
correct operation and ensures patient and operator safety.
This manual is based on the maximum configuration of
Portable ECG monitor
.
1.1 Safety
Warnings
Before using the device, please ensure that you have read this manual thoroughly and fully understand
corresponding precautions and risks.
This device has been designed for practical use, but is not a substitute for a visit to the doctor.
The data and results displayed on the device are for reference only and cannot be directly used for
diagnostic interpretation or treatment.
We recommend not to use this device if you have a pacemaker or other implanted devices. Follow the
advice given by your doctor, if applicable.
Users should always consult their physician if they notice changes in their health.
Messages after measurement report heart rate and heart rhythm only.
This device neither detects nor measures all heart rate, heart rhythm and heart waveform changes,
especially those related to ischemic heart conditions.
Do not use this device with a defibrillator.
Never submerge the device in water or other liquids. Do not clean the device with acetone or
other volatile solutions.
Do not drop this device or subject it to strong impact.
Do not place this device in pressure vessels or gas sterilization device.
Do not dismantle the device, as this could cause damage or malfunctions or impede the
operation of the device.
This device is not intended for use by people (including children) with restricted physical,
sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are
supervised by a person who has responsibility for their safety or they receive instructions
from this person on how to use the device. Children should be supervised around the device
to ensure they do not play with it.
Do not allow the electrodes of the device to come into contact with other conductive parts
(including earth).
Do not use the device with persons with sensitive skin or allergies.
Do not store the device in the following locations: locations in which the device is exposed to
direct sunlight, high temperatures or levels of moisture, or heavy contamination; locations
near to sources of water or fire; or locations that are subject to strong electromagnetic
influences.
Do not swing the device with the strip, which may result in injury.
This device displays changes in the heart rhythm and blood oxygenation etc. which may have
various different causes. These may be harmless, but may also be triggered by illnesses or
diseases of differing degree of severity. Please consult a medical specialist if you believe you
may have an illness or disease.
Vital signs measurements, such as those taken with this device, cannot identify all diseases.
Regardless of the measurement taken using this device, you should consult your doctor
