2 - 1
2
Equipment Introduction
2.1
Intended Use
The ePM 10M/ePM 10MA/ePM 10MC/ePM 12M/ePM 12MA/ePM 12MC patient monitor, hereafter called the
monitor, is intended to be used for monitoring, displaying, reviewing, storing, alarming and transferring of
multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead, and 12-lead selectable, arrhythmia
detection, ST segment analysis, QT/QTc monitoring, and heart rate (HR)), respiration (Resp), temperature (Temp),
pulse oxygen saturation (SpO
2
), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure
(IBP), cardiac output (C.O.), carbon dioxide (CO
2
), oxygen (O
2
), anesthetic gas (AG) and bispectral index (BIS). The
monitor also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric and neonatal patients with the exception of the
following:
■
C.O. monitoring is only intended for adult patients.
■
The PAWP and BIS monitoring are intended for adult and pediatric patients only.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It is not
intended for helicopter transport, hospital ambulance, or home use.
WARNING
•
This monitor is intended for use only by clinical professionals or under their guidance. It must only
be used by persons who have received adequate training in its use. Anyone unauthorized or
untrained must not perform any operation on it.
2.2
Applied Parts
The applied parts of the monitor are:
■
ECG electrode and leadwire
■
SpO
2
sensor
■
Temp probe
■
NIBP cuff
■
IBP transducer
■
C.O. sensor
■
CO
2
sampling line/nasal sampling cannula, water trap, and mask
■
AG sampling line, water trap, airway adapter, and mask
■
BIS sensor
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