RD SET™ E1® Ear Sensor
Single Patient Use Ear Sensor
Single patient use only
Prior to using this sensor, the user should read and understand the Operator's Manual for the monitor
and this Directions for Use.
INDICATIONS
The RD SET™ E1® Ear Sensor is indicated for single patient use for continuous non-invasive monitoring of functional oxygen
saturation of arterial hemoglobin (SpO
(weighing >30 kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
CONTRAINDICATIONS
The RD SET E1 Ear Sensor is contraindicated for patients who exhibit allergic reactions to foam rubber products and/
or adhesive tape or for patients with signs of redness, swelling, infection or skin breakdown at the sensor application site,
including the inner aspect of the ear and behind the ear. The sensor cannot be placed over areas of the ear that have piercings.
Refer to Fig. 1. The sensor should not be used on patients if the inner aspect of the ear (cavum conchae [A]) (reference is
also made to the tragus [B], ear lobe [C] and crus of helix [D].) is not large enough to accommodate the emitter limb of the
sensor without touching the tragus and/or crus of helix. The sensor is not intended for use on a monitoring site for prolonged
periods. If extended monitoring is required, the sensor must be moved to the opposite ear. If the sensor cannot be moved,
use of a Masimo adhesive sensor on a peripheral site, such as the digit, is recommended.
Because individual skin conditions and perfusion levels affect the ability of the site to tolerate sensor placement, it may be
necessary to move the sensor frequently.
DESCRIPTION
The RD SET E1 Ear Sensor are for use only with devices containing Masimo SET® MS-2000 (Version 4.8 or higher) technology,
Masimo rainbow® SET® MX technology.
The RD SET E1 Ear Sensor has been verified using Masimo SET Oximetry technology.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET® oximetry or licensed to
use Masimo sensors.
WARNINGS
• Do not use the E1 Ear Sensor on any site other than the inner aspect of the ear (cavum conchae). This may result in
inaccurate readings due to tissue thickness.
• All sensors and cables are designed for use with specific monitors. Verify the compatibility of the monitor, cable and
sensor before use, otherwise degraded performance and/or patient injury can result.
• The site must be checked frequently or per clinical protocol to ensure adequate adhesion, circulation, skin integrity and
correct optical alignment.
• Exercise extreme caution with poorly perfused patients; skin erosion and pressure necrosis can be caused when the
sensor is not frequently moved. Assess site as frequently as every (1) hour with poorly perfused patients and move the
sensor if there are signs of tissue ischemia.
• During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to
pressure necrosis.
• With very low perfusion at the monitored site, the reading may read lower than core arterial oxygen saturation.
• Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. Use of
additional tape can cause skin damage, and/or pressure necrosis or damage the sensor.
• Sensors applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure
necrosis.
• Misapplied sensors or sensors that become partially dislodged may cause incorrect measurements.
• Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous
outflow from monitored site. Sensor should not be below heart level (e.g. sensor on hand of a patient in a bed with arm
dangling to the floor, Trendelenburg position).
• Venous pulsations may cause erroneous low SpO
• The pulsations from intra-aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display.
Verify patient's pulse rate against the ECG heart rate.
D I R E C T I O N S F O R U S E
Not made with natural rubber latex
LATEX
PCX-2108A
02/13
) and pulse rate (measured by an SpO
2
readings (e.g. tricuspid valve regurgitation, Trendelenburg position).
2
3
sensor) for use with adult and pediatric patients,
2
Title: Graphics, Sensor/Cable symbols,
03/06
GR-14231
en
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Non-sterile
NON
STERILE
5%-95% RH
LATEX
95%
5%
9025B-eIFU-0119