2 Definitions
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201000401000 / Rev 04
2.3 Provisions and Safety Information
This section contains information on the safe use of the system and on observance of legal regula-
tions. Familiarize yourself with this information. Read and understand all instructions before
attempting to use this system.
Any failure to observe the safety information contained herein is considered improper use of the
system, which may lead to injuries, loss of data and may render the warranty null and void.
2.3.1 Safety Information
The following safety information refers to the system as a whole. Specific safety information may
be presented in other sections of this manual.
Safety Text
WARNING No monitoring device
There is a risk of life-threatening patient conditions going unnoticed.
The ECG system is not suitable for the electrocardiographic monitoring of critical care patients.
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).
WARNING Conductive materials
Electric shocks or malfunction of the ECG system may result from contact with conductive mate-
rials.
Conductive parts of the ECG system must not touch other conductive parts, including ground,
during application to or removal from the patient.
Follow the sequence of steps for application and removal of the ECG system described in this
manual.
WARNING Visual inspection before use
Before each use, visually inspect the ECG system for signs of damage. If you detect damage that
may result in a hazard to the patient or the operator, the ECG system must be repaired before it
can be used again. Follow the instructions for visual inspection given in this manual.
WARNING Defibrillation protection
To ensure defibrillation protection, use only the electrodes, leadwires, and patient cables with the
1-channel transmitter specified by the manufacturer.
When a defibrillation shock was delivered, all components must be inspected by a certified
ergoline service partner for possible damage.
WARNING Compatibility
Safe and reliable operation of the ECG system is only possible when ergoline has declared the
devices connected to the ECG system to be part of the ECG system or compatible with the ECG
system.
CAUTION Incorrect application
The ECG system is not intended for long-term monitoring. Skin irritation and/or allergies may occur.
Apply the ECG system only as described in this manual.
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