Masimo Rad-G Manuel De L'utilisateur page 4

• WARNING: To ensure safety, avoid placing anything on the device during operation.
• WARNING: As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation.
• CAUTION: Do not place the Rad-G where the controls can be changed by the patient.
• CAUTION: Do not place Rad-G where the AC power supply cannot be readily disconnected when used on AC power.
• CAUTION: To ensure patient electrical isolation, all external device connections to the output interface connector must be done using only
authorized data cables.
• Note: Disconnect the device from AC mains by unplugging the AC power supply from the Rad-G.
• Note: Use and store the Rad-G in accordance with specifications. See the Specifications section in this manual.
• Note: The maximum skin surface temperature is measured to be less than 41°C (106°F) in a 35°C (95°F) environment. This was verified by
measuring the skin interface temperature with Rad-G operating under reasonable worst-case conditions.
Performance Warnings and Cautions
• WARNING: The Screening Mode in the Rad-G is intended to help clinicians follow established screening protocols and is not intended to be used
as a diagnostic or sole screening tool.
• WARNING: The Screening Mode screening result is not a definitive assessment of the patient's condition. The result should be evaluated in
conjunction with the patient's clinical status and confirmed with additional diagnostic tests consistent with each hospital's policy.
• WARNING: During Screening, the SpO
• WARNING: Rad-G is intended for spot-checking only, no physiological alarms are provided.
• WARNING: Rad-G should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms.
• WARNING: The Rad-G and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions; it is intended to
be used in conjunction with additional methods of assessing clinical signs and symptoms.
• WARNING: If any measurement seems questionable, first check the patient's vital signs by alternate means and then check Rad-G for proper
functioning.
• WARNING: Rad-G should not be used as a replacement or substitute for ECG-based arrhythmia analysis.
• WARNING: Rad-G may be used during defibrillation. This may affect the accuracy or availability of the parameters and measurements.
• WARNING: Rad-G may be used during electrocautery. This may affect the accuracy or availability of the parameters and measurements.
• WARNING: Properly apply sensors according to sensor's directions for use. Misapplied sensor or sensors that become partially dislodged may
cause no or incorrect readings.
• WARNING: Select a well perfused site for monitoring, very low perfusion at the monitored site may result in no or incorrect readings.
• WARNING: Do not use Rad-G on patients that have been injected with dyes or any substance containing dyes, the change in usual blood
pigmentation may cause no or incorrect readings.
• WARNING: Displayed parameter(s) may not be accurate when a low SIQ message is provided. Clinicians should consider additional information
to supplement values to completely understand the patient's condition.
• WARNING: If SpO values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient's condition.
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• WARNING: SpO is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin
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(MetHb).
• WARNING: Optical, pleth-based measurements (e.g. SpO
• Improper sensor application or use of use of incorrect sensor.
• Blood pressure cuff applied to the same arm as the sensor site.
• Intravascular dyes such as indocyanine green or methylene blue.
• Venous congestion.
• Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg position).
• Abnormal pulse rhythms due to physiological conditions or induced through external factors (e.g. cardiac arrhythmias, intra-aortic balloon,
etc.).
• Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
• Moisture, birthmarks, skin discoloration, nail aberration, deformed fingers, or foreign objects in the light path.
• Elevated levels of bilirubin.
• Physiological conditions that can significantly shift the oxygen disassociation curve.
• A physiological condition that may effect vasomotor tone or changes in vasomotor tone.
• WARNING: Inaccurate SpO
• Elevated levels of COHb and/or MetHb.
• Severe anemia.
• Extremely low arterial perfusion.
• Excessive induced motion.
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (quantitative defects such as
Thalassemias).
• WARNING: Inaccurate RRp readings may be caused by:
• Low arterial perfusion.
• Motion induced artifact.
• Severe anemia.
• CAUTION: If using Rad-G during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the
reading might be inaccurate or the device might read zero for the duration of the active irradiation period.
• CAUTION: When patients are undergoing photodynamic therapy they may be sensitive to light sources. Pulse oximetry may be used only under
careful clinical supervision for short time periods to minimize interference with photodynamic therapy.
• CAUTION: 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.
• CAUTION: 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.
• CAUTION: If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if
indicated, verify oxygenation status through other means.
• CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity
to Rad-G.
trend line should be monitored for low saturation events.
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readings may be caused by:
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and RRp) can be affected by the following:
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