Masimo E1 Serie Instrucciones De Uso página 5

• The sensor should be free of visible defects, discoloration and damage. If the sensor is discolored or damaged, discontinue use.
Never use a damaged sensor or one with exposed electrical circuitry.
• Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
• If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If sensor is exposed to the radiation,
the reading might be inaccurate or the unit might read zero for the duration of the active radiation period.
• Do not use the sensor during MRI scanning or in a MRI environment.
• High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights,
infrared heating lamps, and direct sunlight can interfere with the performance of the sensor.
• To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque
material, if required. Failure to take this precaution in high ambient light conditions may result in inaccurate measurements.
• High levels of COHb or MetHb may occur with a seemingly normal SpO2. When elevated levels of COHb or MetHb are
suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2 measurements.
• Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 measurements.
• Elevated Total Bilirubin levels may lead to inaccurate SpO2 measurements.
• Intravascular dyes such as indocyanine green or methylene blue or externally applied coloring (such as indelible ink) may lead
to inaccurate SpO2 measurements.
• Inaccurate SpO2 readings may be caused by severe anemia, low arterial perfusion or motion artifact.
• To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilize the sensor.
• Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or accuracy.
• Do not attempt to reuse on multiple patients, reprocess, recondition or recycle Masimo sensors or patient cables as these
processes may damage the electrical components, potentially leading to patient harm.
INSTRUCTIONS
A) Site selection
CAUTION: Before using the sensor, ensure that the sensor is physically intact, with no broken or frayed wires or damaged
parts.
• Refer to Fig 1. The preferred measuring site is the hollow of 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].)
• The site should be free of debris. Prior to sensor placement, the site should be checked to ensure that it is clean, without
signs of redness, swelling, infection or breakdown.
B) Attaching the Sensor to the Patient
1. Open the pouch and remove the sensor.
2. Refer to Fig 2. Orient the sensor to ensure that the star (1) on the emitter limb is in front of the patient's ear. Gently pull
the emitter and detector limb apart to separate, so they will clear the ear lobe. Place the emitter limb inside the ear so
that it rests on the hollow of the inner aspect of the ear (cavum conchae).
3. Place the detector limb on the back of the ear (2). The detector limb pad should lay flat on the back of the ear, without
any part of the pad folding under.
4. Position the bottom of the sensor notch (3) so that it fits under the smallest portion of the ear lobe. For the patient's
comfort, the E1 Ear Sensor can be adjusted after it is placed. Ensure that the sensor is not compressing any skin. It is
recommended that the emitter not touch the tragus.
5. If the Masimo Ear sensor does not fit properly on the ear, consider using a Masimo reusable or adhesive sensor on
another measuring site.
6. The patient should turn their head to the opposite side from the ear where the sensor is attached. Attach the anchor
tab on the cable to the anchor pad. Remove the release liner from the anchor pad. Secure the pad to the skin on the
patient's shoulder area. Refer to Fig. 3. Do not secure to the patient's clothing.
C) Attaching the Sensor to the Patient Cable
LNCS
1. Refer to Fig 4a. Properly orient the sensor and patient cable connectors and insert the sensor connectors completely
into the patient cable connector.
2. Refer to Fig 4b. Completely close the protective cover.
M-LNCS
1. Refer to Fig 5. Orient sensor connector to patient cable connector as shown.
2. Insert the sensor connector completely into the patient cable connector until it locks in place.
NOTE: When changing application sites, or reattaching sensor, first attach the sensor to the application site, then connect the patient cable
to the sensor.
Stress and Exercise Testing
1. Attach the E1 Ear Sensor to the patient following the steps in B (Attaching the Sensor to the Patient).
2. Minimize unnecessary sensor motion during excessive patient movement. Using a headband, loop the ear sensor
cable under the chin, and secure the cable under the headband on the side of the head opposite the ear sensor.
5
6041L-eIFU-0421