Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual
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CONTRAINDICATIONS: The Rad-57 is contraindicated for use as an apnea monitor.
Safety Information, Warnings and Cautions
The Rad-57™ is designed to minimize the possibility of hazards from errors in the software program
by following Sound Engineering Design Processes, Risk Analysis and Software Validation.
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The
Rad-57 is to be operated by qualified personnel only. This manual, accessories,
Directions
for Use
, all precautionary information, and specifications should be read before use.
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Explosion hazard. Do not use the Rad-57 in the presence of flammable anesthetics or other
flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
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Electric shock hazard. Do not open the Rad-57 cover except to replace the batteries. Only a
qualified operator may perform maintenance procedures specifically described in this manual.
Refer servicing to Masimo for repair of this equipment.
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High intensity extreme lights (such as pulsating strobe lights and direct sunlight) directed on the
sensor, may not allow the Rad-57 to obtain readings.
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EMI radiation interference such as computer displays and/or LCD/plasma TVs can cause
errors or incorrect measurements on the Rad-57.
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If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to
completely understand the patient's condition.
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Pulse rate measurement is based on the optical detection of a peripheral flow pulse and
therefore may not detect certain arrhythmias. The Rad-57 should not be used as a replacement
or substitute for ECG based arrhythmia analysis.
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As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
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Do not place the Rad-57 or accessories in any position that might cause it to fall on the patient.
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Do not lift the Rad-57 b
y the patient ca
ble or sensor.
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Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
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Rad-57 should not be used as the sole basis for diagnosis or therapy decisions. It must be used
in conjunction with clinical signs and symptoms.
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Always remove the sensor from the patient and completely disconnect the patient from the Rad-
57 before bathing the patient.
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Interfering Substances: Dyes, or any substance containing dyes, that change usual blood
pigmentation may cause erroneous readings.
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Do not use the Rad-57 or sensors during magnetic resonance i
maging (MRI) scanning. Induced
current could potentially cause burns. The Rad-57 may affect the MRI image, and the MRI device
may affect the accuracy of the Pulse CO-Oximetry parameters and measurements.
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Do not use the Rad-57 during electrocautery.
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Do not use the Rad-57 or sensor during defibrillation.
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If using the Rad-57 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 instrument might read
zero for the duration of the active irradiation period.
Summary of Contents for Rad-57
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