Product Overview
Operator’s Manual Addendum
ADD-7
1.3
Product Overview
1.3.1
Product Description
The Covidien Nellcor™ Respiration Rate Version 2.0 parameter as featured on
the Nellcor™ Bedside Respiratory Patient Monitoring System allows for con-
tinuous noninvasive monitoring of arterial oxygen saturation (SpO
2
), pulse rate
and respiration rate of adult patients using a single sensor. The pulse oximeter
collects the photoplethysmography signal from the patient via the Covidien
Nellcor™ Adult Respiratory Sensor attached to the patient. This signal is pro-
cessed by the pulse oximeter to determine patient SpO
2
and pulse rate data,
which are displayed on the monitor user interface along with trending, system
status, and alarm information. These data are stored on the monitor and avail-
able for subsequent export.
1.3.2
Indications for Use
The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse
oximeter intended for prescription use only as a continuous non-invasive
monitor of arterial oxygen saturation (SpO
2
) and pulse rate of adult, pediatric,
and neonatal patients during both motion and no motion conditions, and for
patients who are well or poorly perfused. The monitoring system is intended for
use in hospitals, hospital-type facilities, and during intra-hospital transport. The
OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults
to detect patterns of desaturation indicative of repetitive reductions in airflow
through the upper airway and into the lungs.
The Nellcor™ Respiration Rate parameter, when used in conjunction with the
Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ Adult
Respiratory Sensor, is intended for the continuous, non-invasive monitoring of
respiration rate in adult patients in hospitals and hospital-type facilities.
1.3.3
Updated Monitoring Screens
The user interface components remain the same as those listed in the
Opera-
tor’s Manual
, with the addition of the new respiration rate field at the lower
right of the monitoring screen. In trend views, respiration rate data is shown
as a white trend line.
