Equipment Information; Intended Use Of This Equipment; Safety Statements; Dangers - GE ApexPro Operator's Manual

Introduction

Equipment information

Intended use of this equipment

Safety statements

Dangers

Warnings

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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 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.
The safety statements presented in this chapter refer to the equipment in general and,
in most cases, apply to all aspects of the device. There are additional safety statements
in other chapters which are specific to that chapter content.
The order in which safety statements are presented in no way implies the order of
importance.
Danger statements identify an imminent hazard which, if not avoided, will result in
death or serious injury. No danger statements apply to this system.
Warning statements identify a potential hazard or unsafe practice which, if not
avoided, could result in death or serious injury.
The following warning statements apply to this system.
WARNING
Do not monitor pacemaker patients with a 3-leadwire set when
reliable pacer detection is required. Pacer pulse detection can be
erratic when only a single vector is monitored. Always use a 5- or 6-
leadwire set when reliable pacer detection is required.
ApexPro™ 2001989-200E