GE ApexPro TT, Technical Manual

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Introduction
2001989-351A ApexPro™ 1-3
Safety information
Intended use
The ApexPro Telemetry System is intended for use under the direct supervision of a
licensed healthcare practitioner. The system is designed to acquire and monitor
physiological data for ambulating adult and pediatric patients within a defined
coverage area. The system processes this physiological data to detect various ECG
arrhythmia events and select physiological parameter limit violations.
The ApexPro Telemetry System is intended to be installed in the hospital or clinical
environment in order to provide clinicians with patient physiological data, while
allowing for patient mobility. These systems are typically deployed in sub acute care
areas in hospitals or clinical sites where patient mobility can enhance the
effectiveness of the medical procedures administered.
The physiological parameters monitored include ECG, non-invasive blood pressure,
non-invasive temperature and SpO2. The ApexPro Telemetry System is intended to
provide ECG data via Ethernet to the computer platform for processing. The ApexPro
is also intended to provide physiologic data over the Unity network to clinical
information systems for display.
Responsibility of the manufacturer
GE is responsible for the effects of safety, reliability, and performance only if:
„ assembly operations, extensions, readjustments, modifications, or repairs are
carried out by persons authorized by GE;
„
the electrical installation of the relevant room complies with the requirements of
the appropriate regulations; and
„ the device is used in accordance with the instructions for use.
Equipment symbols
NOTE
Some symbols may not appear on all equipment.
ATTENTION: Consult accompanying documents.
Non-ionizing electromagnetic radiation: To indicate elevated, potentially dangerous, levels of non-ionizing radiation. Note -
In case of application in a warning sign the rules according to ISO 3864-1 shall be adhered to.
IEC 60878 note: See safety sign ISO 7010 - W005 “Warning, non-ionizing radiation”.