1 General Notes
ers2 – 1-Channel ECG Telemetry System 7
201000401000 / Rev 04
1 General Notes
This manual describes the ers2 ECG system and is geared for the primary and secondary users of these
devices. The ECG system is intended for use with a medical application software or ME equipment.
The ECG system is intended for use with the ergoline rehabilitation software (ers2) among others.
The software processes the acquired ECG signal, saves it, and uses it to continuously monitor and
document the heart rate and the cardiac rhythm and to control the training load for rehabilitation
or preventive training activities of adult patients. For the relevant wireless connections and special
functional tests, refer to the instructions for use of the application software.
If you intend to use the ECG system with a software not expressly approved by ergoline, please
contact the manufacturer of this software for information on installation, configuration, and pos-
sible restrictions.
1.1 General Information
This manual is an integral part of the device. It should be kept near the device at all times.
This manual provides the necessary information for safe transport and storage, setup and safe
operation in compliance with its function and as defined by its intended use. This system man-
ual is not a substitute for in-depth product training, it should rather be considered as a supple-
ment.
The symbol means: Follow instructions in accompanying documents.
It indicates points that are of particular importance in the application of the device.
The manual reflects the device specifications and applicable safety standards valid at the time of
printing. All rights are reserved for devices, circuits, techniques, software programs, and names
appearing in this manual.
The CE mark and the CE approval number 0123 indicate that the device is in conformity with the
applicable rules and requirements set out in Regulation (EU) 2017/745.
It is an active class IIa device for "transient" use on patients.
The device has been certified with respect to electric shock, fire, mechanical hazards, electromag-
netic compatibility, and signal accuracy in accordance with IEC 60601-1, IEC 60601-1-2, and IEC
60601-2-27.
WARNING No pacemaker detection
There is a risk of inadequate therapy and/or over-exertion.
The 1-channel system may continue to count the pacemaker rate during cardiac arrest or some
arrhythmias. Do not rely entirely upon rate meter alarms.
The 1-channel transmitter has no pacemaker pulse rejection capability.
Keep pacemaker patients under close surveillance. The primary user is required to periodically assess
the current exertion level by referring to independent, subjective parameters (e.g., the RPE value).
CAUTION Prescription device
Please note that US Federal Law restricts this ECG system to be used by a physician or on the order
of a physician.
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