• Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO
• Elevated Total Bilirubin levels may lead to inaccurate SpO
• Intravascular dyes such as indocyanine green or methylene blue or externally applied coloring (such as indelible ink) may
lead to inaccurate SpO
• Inaccurate SpO
readings may be caused by severe anemia, low arterial perfusion or motion artifact.
2
• 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.
• Caution: Replace the sensor when a replace sensor message is displayed, or when a low SIQ message is consistently
displayed after completing the low SIQ troubleshooting steps identified in the monitoring device operator's manual.
• Note: The sensor is provided with X-Cal® technology to minimize the risk of inaccurate readings and unanticipated loss
of patient monitoring. The sensor will provide up to 168 hours of patient monitoring time or up to 336 hours for sensors
with a replaceable tape. After single-patient use, discard sensor.
INSTRUCTIONS
A) Site Selection
• Ensure that the patient's skin is clean, dry and free of debris and oil.
• Do not place the RD SET TFA-1 on sites with a palpable pulse.
• The preferred measuring site is the forehead, above the eyebrow.
B) Attaching the sensor to the patient
CAUTION: Headband must be used to avoid inaccurate readings.
Initial Application
1. Remove the sensor from the release liner.
2. Refer to Fig. 1. Apply the sensor to the forehead. Sensor should be just above the eyebrow with the center lines in line
with the center of the eye (pupil).
3. Refer to Fig. 2. Apply the headband. Headband should be secure enough to apply slight pressure to the sensor and
should completely cover the sensor.
4. The cable should be routed up and over the headband so the cable does not apply pressure to the skin and is not pulling
on the sensor.
C) Attaching the Sensor to the Patient Cable
1. Refer to Fig. 3. Orient the sensor's connector tab so that the side with the "shiny" contacts is facing up. Orient the patient
cable with the color bar and finger grips facing up.
2. Refer to Fig. 4. Insert the sensor tab into the patient cable until there is a tactile or audible click of connection. Gently tug
on the connectors to ensure a positive contact.
D) Disconnecting the Sensor from the Patient Cable
1. Refer to Fig. 5. Pull firmly on the sensor connector to remove it from the patient cable.
NOTE: To avoid damage, pull on the sensor connector, not the cable.
E) Reattachment
• The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still
adheres to the skin.
NOTE: When changing application sites, or reattaching sensor, first attach the sensor to the application site, then connect
the patient cable to the sensor.
Using a New Adhesive Pad
• The adhesive pads included with the RD SET TFA-1 sensors are double sided adhesive pads used when the stickiness of
the adhesive covering the sensor is no longer effective.
• Up to 3 adhesive pads may be applied to each sensor placing one on top of the other.
1. Remove one of the adhesive pads from the strip.
2. Refer to Fig. 6. Place the adhesive pad over the sensor as shown. Do not cover the emitter or detector, located in the
center of the sensor.
3. Refer to Fig. 7. Remove the protective paper that covers the pad.
4. Refer to Steps 2 through 4 under "Initial Application" for patient application.
NOTE: If the adhesive no longer adheres to the skin, use a new sensor.
measurements.
2
measurements.
2
measurements.
2
4
9508D-eIFU-0319