Directions For Use - Masimo E1 Serie Instrucciones De Uso

E1 Series Ear Sensors
LNCS®/M-LNCS® Single Patient Use Ear Sensor
Single Patient Use Only
INDICATIONS
The E1 Ear Sensor is indicated for single patient use for continuous non-invasive monitoring of functional oxygen saturation of
arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients, (weighing
>30 kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
When Used with:
Application Site
NON
STERILE
Saturation Accuracy, No Motion
LATEX
Pulse Rate Accuracy, No Motion
%
Low Perfusion Accuracy
5%
Tit le: G rap hics, Sensor/C able symb ols, 03/06
GR-14231
DRO-13914
DESCRIPTION
The E1 Series Ear Sensors are intended for use only with instruments containing Masimo SET® MS-2000 (Version 4.8 or higher)
technology, Masimo rainbow® SET® MX technology.
The E1 Ear Sensor has been validated on Masimo SET Oximetry technology, which is included in the Radical-7®, Rad-8®, Rad-
5®, Rad-87®, and Rad-57® instruments.
WARNING: Masimo sensors and cables are designed for use with instruments containing Masimo SET® oximetry or licensed
to use Masimo sensors.
CONTRAINDICATIONS
The 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.
WARNINGS
• Do not use the E1 Ear Sensor 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 SpO2 readings (e.g. tricuspid valve regurgitation, Trendelenburg position).
• 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 IREC TIO NS FOR U SE
Not made with natural rubber latex
LATEX
PCX-2108A
02/13
+70 C
-40 C
+1060 hPa - +500 h
795 mmHg - 375 mmHg
5%-95% RH
95%
Masimo
> 30 kg
Ear
± 2.5%
± 3 bpm
SpO2 ± 2.5%
Pulse ± 3 bpm
4
Non-sterile
NON
STERILE
LATEX
%
5%
Tit le: G rap hics, Sensor/C able symb ols, 03/06
GR-14231
DRO-13914
6041L-eIFU-0421
en
+70 C
>30 kg
-40 C
+1060 hPa - +500 h
795 mmHg - 375 mmHg
5%-95% RH
95%