GE Medical Systems Information Technologies 2014748 Users Manual

2 Safety

Revision B ApexPro Telemetry System 2-1

2001989-134

For your notes

2-2 ApexPro Telemetry System Revision B

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For Your Safety

Intended Use

Safety: For Your Safety

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 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.

Definitions

The terms danger, warning, and caution are used throughout this
manual to point out hazards and to designate a degree or level or
seriousness. Familiarize yourself with their definitions and significance.

Hazard is defined as a source of potential injury to a person.

DANGER indicates an imminent hazard which, if not avoided, will
result in death or serious injury.

WARNING indicates a potential hazard or unsafe practice which, if not
avoided, could result in death or serious injury.

CAUTION indicates a potential hazard or unsafe practice which, if not
avoided, could result in minor personal injury or product/property
damage.

NOTE provides application tips or other useful information to assure
that you get the most from your equipment.

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System Safety

Dangers

Warnings

Safety: For Your Safety

The safety statements presented in this chapter refer to the equipment
in general and, in most cases, apply to all aspects of the telemetry
system. There are additional safety statements in other chapters that are
specific to the information presented in that chapter.

The order in which safety statements are presented in no way implies
order of importance.

There are no dangers that refer to the equipment in general. Specific
“Danger” statements may be given in the respective sections of this
manual.

WARNINGS

ACCIDENTAL SPILLS — To avoid electric shock or
device malfunction liquids must not be allowed to enter
the device. If liquids have entered a device, take it out of
service and have it checked by a service technician before
it is used again.

ACCURACY — If the accuracy of any value displayed on
the monitor, central station, or printed on a graph strip is
questionable, determine the patient's vital signs by
alternative means. Verify that all equipment is working
correctly.

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Safety: For Your Safety

WARNINGS

ALARMS — Do not rely exclusively on the audible alarm
system for patient monitoring. Adjustment of alarm
volume to a low level or off during patient monitoring
may result in a hazard to the patient.

Do not rely exclusively on the alarm pause breakthrough
feature for alarm notification during an alarm pause.
This may result in a hazard to the patient. Only crisis
alarms break through an alarm pause.

Remember that the most reliable method of patient
monitoring combines close personal surveillance with
correct operation of monitoring equipment.

After connecting the monitor to the central station, nurse
alert system, and/or network, verify the function of the
alarm system.

The functions of the alarm system for monitoring of the
patient must be verified at regular intervals.

BEFORE USE — Before putting the system into
operation visually inspect all connecting cables for signs
of damage. Damaged cables and connectors must be
replaced immediately.

Before using the system, the operator must verify that it
is in correct working order and operating condition.

Periodically, and whenever the integrity of the product is
in doubt, test all functions.

CABLES — Route all cables away from patient's throat
to avoid possible strangulation.

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