Masimo RD SET DBI Mode D'emploi page 4

• 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
• 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 and severe
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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 sensor 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 message is displayed, or when a low SIQ message is consistently displayed while
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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
• Choose a site that is well perfused and least restricts a conscious patient's movements. The ring finger of the non-dominant hand is preferred.
• Site should be cleaned of debris prior to sensor placement.
B) Attaching the sensor to the patient
1. Refer to Fig. 1. Hold the sensor with star and cable on top. Open the sensor by pressing on the sides of the sensor. Insert the selected digit
into the sensor.
2. Refer to Fig. 2. Orient the sensor so that the cable runs toward the top of the patient's hand. The tip of the finger should touch the raised
digit stop inside the bottom of the sensor. If the fingernail is long, it may extend through the opening at the end of the sensor. Check the
arrangement of the sensor to verify correct positioning. Release the sides of the sensor. Complete coverage of the detector is needed to
ensure accurate data.
C) Attaching the Sensor to the Patient Cable
1. Refer to Fig. 3. Properly orient the sensor connector and insert the sensor connector completely into the patient cable connector.
2. Refer to Fig. 4. Close the protective latch cover completely.
D) Disconnecting the Sensor from the Patient Cable
1. Refer to Fig. 5. Lift up the protective cover.
2. Refer to Fig. 6. 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.
CLEANING
To surface clean the sensor:
1. Remove the sensor from the patient and disconnect it from the patient cable.
2. Clean the sensor surface by wiping it with a 70% isopropyl alcohol pad.
3. Allow the sensor to dry prior to placement on a patient. If low-level disinfection is required, proceed to steps 4 through 7.
4. Saturate a cloth or gauze pad with one of the following solutions:
• Glutaraldehyde (such as Metrex, Metricide 28 or Cidex 2250)
• Ammonium Chlorides (such as ECOLAB, Huntington Brand, Aspeti-Wipe)
• 1:10 bleach/water solution
5. Wipe all surfaces of the sensor and cable.
6. Saturate another cloth or gauze pad with sterile or distilled water and wipe all surfaces of the sensor and cable.
7. Dry the sensor and cable by wiping all surfaces with a clean cloth or dry gauze pad.
To clean or disinfect the sensor using a soaking method:
1. Place the sensor in one of the following cleaning solutions, so that the sensor and desired length of cable are completely immersed.
• Glutaraldehyde (such as Metrex, Metricide 28 or Cidex 2250)
• Ammonium Chlorides (such as ECOLAB, Huntington Brand, Aspeti-Wipe)
• 1:10 bleach/water solution
2. Dislodge air bubbles by gently shaking the sensor and cable.
3. Soak the sensor and the cable for at least 10 minutes and not greater than 24 hours. Do not immerse the connector.
4. Remove from cleaning solution.
5. Place the sensor and the cable in room temperature sterile or distilled water for 10 minutes. Do not immerse the connector.
6. Remove from the water.
7. Dry the sensor and cable by wiping all surfaces with a clean cloth or dry gauze pad.
Caution:
• Do not use undiluted bleach (5–5.25% sodium hypochlorite) or any cleaning solution other than those recommended herein because
permanent damage to the sensor could occur.
• Do not immerse the connector on the cable in any liquid solution.
• Do not sterilize by irradiation, steam, autoclave, or ethylene oxide.
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readings.
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9022B-eIFU-0119