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Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual iii
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
Do not expose the Pulse CO-Oximeter to excessive moisture such as direct exposure
to rain. Excessive moisture can cause the Pulse CO-Oximeter to perform inaccurately
or fail.
Do not place containers containing liquids on or near the Pulse CO-Oximeter. Liquids
spilled on the Pulse CO-Oximeter may cause it to perform inaccurately or fail.
Failure of Operation - If the Pulse CO-Oximeter fails any part of the setup
procedures remove the Pulse CO-Oximeter from operation until qualified service
personnel have corrected the situation.
Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
The Pulse CO-Oximeter can be used during defibrillation, but the readings may be
inaccurate for up to 20 seconds.
This equipment has been tested and found to comply with the limits for medical
devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC. These limits
are designed to provide reasonable protection against harmful interference in a typical
medical installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment does
cause harmful interference to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one
or more of the following measures:
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Consult the manufacturer for help.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Rad-57 Pulse CO-Oximeter 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.
Explosion hazard. Do not use the Pulse CO-Oximeter in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
The Pulse CO-Oximeter is NOT intended for use as an apnea monitor.
A Pulse CO-Oximeter should be considered an early warning device. As a trend
towards patient hypoxemia is indicated, blood samples should be analyzed by
laboratory instruments to completely understand the patient’s condition.
The Pulse CO-Oximeter is to be operated by qualified personnel only. This manual,
accessory directions for use, all precautionary information, and specifications should
be read before use.
Electric shock hazard. Do not open the Pulse CO-Oximeter 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.
As with all medical equipment, carefully route patient cabling to reduce the possibility
of patient entanglement or strangulation.
Do not place the Pulse CO-Oximeter or accessories in any position that might cause
it to fall on the patient. Do not lift the Pulse CO-Oximeter by the patient cable.
Interfering Substances: Carboxyhemoglobin may erroneously increase SpO
2
readings.
The level of increase is approximately equal to the amount of carboxyhemoglobin
present. Dyes, or any substance containing dyes, that change usual blood pigmentation
may cause erroneous readings.
Severe anemia may cause erroneous SpO
2
readings.
Do not use the Pulse CO-Oximeter or oximetry sensors during magnetic resonance
imaging (MRI) scanning. Induced current could potentially cause burns. The Pulse
CO-Oximeter may affect the MRI image, and the MRI unit may affect the accuracy of
the oximetry measurements.
If using pulse CO-oximetry during full body irradiation, keep the sensor out of
the irradiation field. If sensor is exposed to the irradiation, the reading might be
inaccurate or the unit might read zero for the duration of the active irradiation period.
Always remove the sensor from the patient and completely disconnect the patient
from the Pulse CO-Oximeter before bathing the patient.
Do not place the Pulse CO-Oximeter where the controls can be changed by the patient.
Do not place the Pulse CO-Oximeter face against a surface. This will cause the alarm
to be muffled.
Do not place the Pulse CO-Oximeter on electrical equipment that may affect the
Pulse CO-Oximeter, preventing it from working properly.
ii Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual
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