2 Definitions
ers2 – 1-Channel ECG Telemetry System 13
201000401000 / Rev 04
CAUTION Insufficient ECG transmission quality
Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart
rate alarms. This problem can be largely avoided by correct application of the chest belt and/or
adapter.
Regularly check the 1-channel transmitter for correct application to the chest belt or adapter and
patient according to the instructions in this manual.
CAUTION Risk of infection
After use, the ECG system may be contaminated with bacteria or viruses.
Clean and disinfect the 1-channel transmitter and the applied parts according to the cleaning and
disinfection instructions in this manual.
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.
CAUTION Risk of infection
The ECG system may only be applied on intact skin (e.g., not over open wounds, lesions, infected or
inflamed areas).
CAUTION Wet environment
There is a risk of burn injuries and insufficient ECG transmission quality.
The ECG system is not suitable for use in highly wet environments. Do not wear it in the shower or
when swimming.
CAUTION MR Unsafe
• There is a risk of injuries from ferromagnetic objects being attracted by the magnetic core of
the MRI system (missile effect).
• Thermal injury and burns may occur due to metal components of the device heating up during
MR scanning.
• The system may generate artifacts in the MR image.
• The system may not function properly due to the strong magnetic and radiofrequency fields
generated by the MR scanner.
• It is not permitted to use the ECG system in the vicinity of an MR scanner.
CAUTION Electrosurgery
There is a risk of skin burns and patient injuries.
It is not permitted to use the ECG system during electrosurgery.
CAUTION No diagnostic device
There is a risk of inadequate or wrong therapy.
The ECG system is not intended for use as a tool to diagnose cardiac conditions (e.g., arrhythmias,
ST elevation, etc.).
Apply the ECG system only as described in this manual.
CAUTION Compulsory presence of a primary user
There is a risk of wrong or missing ECG data leading to inadequate therapy and/or over-exertion.
The ECG system may only be used with patients when the primary user is present. The primary user
is required to periodically assess the current exertion level by referring to independent, subjective
parameters (e.g., the RPE value).
CAUTION Installation and instruction obligation
Incorrect installation or training may lead to wrong application of the ECG system.
The ECG system may only be used if properly installed by a certified ergoline partner and after the
user has been instructed by the certified ergoline partner.
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