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

• Inaccurate readings may be caused by EMI radiation interference.
• Intravascular dyes such as indocyanine green or methylene blue may lead to inaccurate or no readings.
• 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 levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
• Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO
• Elevated levels of total bilirubin may lead to inaccurate SpO
• Inaccurate SpO readings may be caused by severe anemia, very low arterial perfusion, or extreme 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 vasospastic disease such as Raynaud's, and peripheral vascular disease.
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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.
• SpO readings may be affected under very low perfusion conditions at the monitored site.
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• 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 as it will damage the sensor.
• Do not attempt to 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 or a persistent low SIQ message is displayed when the patient
monitoring time is exhausted.
• 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 8,760 hours of patient monitoring time. Replace the sensor when the
patient monitoring time is exhausted.
INSTRUCTIONS
A. Site Selection
• The preferred measuring sites are either the ear lobe or pinna.
• The site should be free of debris prior to sensor placement.
CAUTION: If extended monitoring is required, use of a RD SET disposable sensor is recommended.
CAUTION: Before using the sensor, ensure that the sensor is physically intact, with no broken or frayed wires or damaged parts.
B. Attaching the sensor to the patient
1. To improve perfusion to the ear, rub the earlobe vigorously for 25-30 seconds. The ear lobe can also be rubbed with
rubefacient cream (10-30% methylsalicylate and 2-10% menthol).
CAUTION: Do not use strong vasodilator creams such as nitroglycerine paste.
2. Refer to Fig. 1. Clip the sensor onto the ear lobe or pinna. Orient the cable so that it runs down the neck toward the body.
If the RD SET TC-I sensor does not fit properly on the ear, consider using an RD SET disposable sensor or RD SET reusable
finger clip on another measuring site.
CAUTION: Discontinue use of the ear sensor if there is loss of spring tension sufficient enough to allow slippage or
movement of the sensor from its proper position on the ear lobe or pinna.
CAUTION: Avoid positioning the patient so that external pressure is applied to the sensor at the measuring site.
C. Attaching the Sensor to the Patient Cable
1. Refer to Fig. 2. Properly orient the sensor connector and insert the sensor connector completely into the patient cable connector.
2. Refer to Fig. 3. Close the protective latch cover completely.
D. Stress and Exercise Testing
1. Attach the RD SET TC-I 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.
3. Clip the clothing clip to the patient gown.
E. Disconnecting the Sensor
From the patient cable
1. Refer to Fig. 4. Lift up the protective latch.
2. 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.
From the patient
1. To remove the RD SET TC-I from the patient's ear, gently press open the ear clip and remove.
CAUTION:
To avoid discomfort to the patient or damage to the sensor, do not remove the sensor from the patient's ear by pulling
on the cable.
. When elevated levels of COHb or MetHb are
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measurements.
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measurements.
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readings.
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