Masimo RD SET TF-I Mode D'emploi page 4

• Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
• High levels of COHb or MetHb may occur with a seemingly normal SpO
suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
• Elevated Total Bilirubin levels may lead to inaccurate SpO
• Intravascular dyes such as indocyanine green or methylene blue or externally applied coloring may lead to inaccurate
readings.
• Inaccurate SpO readings may be caused by severe anemia, low arterial perfusion or motion artifact.
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• Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc. may cause inaccurate
SpO readings.
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• Inaccurate SpO readings may be caused by elevated levels of dyshemoglobin, hypocapnic or hypercapnic conditions
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and severe vasoconstriction or hypothermia.
• To prevent interference from ambient light, ensure that the sensor is properly applied. Failure to take this precaution in
high ambient light conditions may result in inaccurate measurements.
• 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.
• Readings provided with a low signal confidence indicator may not be accurate.
• Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or accuracy.
• Clean the sensors prior to reuse on multiple patients.
• To prevent damage, do not soak or immerse the connector in any liquid solution.
• Do not attempt to sterilize by irradiation, steam, autoclave or ethylene oxide.
• Do not attempt to remanufacture, 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 while monitoring consecutive patients 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 8,760 hours of patient monitoring time. Replace the sensor when
the patient monitoring time is exhausted.
INSTRUCTIONS
A. Site Selection
• The preferred measuring site is the forehead just above either eye. Do not place the RD SET TF-I on sites with a palpable
pulse.
• Site should be cleaned of debris and dry prior to sensor placement.
CAUTION: Before using the sensor, ensure the sensor is physically intact, with no broken or frayed wires or damaged
parts.
B. Attaching the sensor to the patient
1. Ensure sensor surface contacting patient skin is dry, clean, free of debris and oil.
2. OPTIONAL Refer to Fig. 1. For added sensor stability, place one adhesive pad on sensor surface to contact patient
skin, being careful to align the pad such that it does not cover sensor lenses. Once pad is securely placed, remove top
release liner by pulling from release liner tab.
WARNING: Do not use adhesive pads if the patient exhibits allergic reactions to adhesive tape.
3. Refer to Fig. 2. Orient the sensor with the emitter and detector 'bumps' toward the patient. Orient the sensor so the
cable runs upwards and away from the patient. Gently press on the sensor so that adhesive pad forms a good contact
with patient skin.
C. Applying the Headband
CAUTION: Headband must be used to avoid inaccurate readings.
1. Refer to Fig. 3. Wrap the Masimo Headband around the patient's head loosely enough to avoid restricting circulation
around the site and tightly enough to maintain proper alignment of the sensor.
2. Refer to Fig. 4. Secure the Headband using the "hook and loop" tab.
3. Refer to Fig. 5. Verify that the sensor is covered and secure behind the Masimo Headband.
4. Use the clothing clip to secure the cable to the patient's gown (not shown).
5. Carefully route the patient cable to reduce the possibility of patient entanglement or strangulation.
D. Attaching the sensor to the patient cable
1. Refer to Fig. 6. Properly orient the sensor connector and insert the sensor connector completely into the patient cable
connector.
2. Refer to Fig. 7. Close the protective latch cover completely.
measurements.
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measurements.
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. When elevated levels of COHb or MetHb are
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measurements.
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