Rad-8 Signal Extraction Pulse Oximeter Operator’s Manual
iii
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
■ If using Rad-8 during full body radiation, keep the sensor out of the radiation fi eld. 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.
■ For home use, ensure that the Rad-8 alarm can be heard from other rooms in the house especially
when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or radios
are operating.
■ Always remove the sensor from the patient and completely disconnect the patient from the Rad-8
before bathing the patient.
■ Additional information specific to Masimo sensors including information about parameter/measurement
performance during motion and low perfusion, may be found in the sensor's Directions For Use (DFU).
■ Do not place the Rad-8 where the controls can be changed by the patient.
■ Do not place the Rad-8 face against a surface. This will cause the alarm to be muffl ed.
■ Do not place the Rad-8 on electrical equipment that may affect the Pulse Oximeter, preventing it from
working properly.
■ Do not expose the Rad-8 to excessive moisture such as direct exposure to rain. Excessive moisture
can cause the device to perform inaccurately or fail.
■ Do not place containers with liquids on or near the Rad-8. Liquids spilled on the device may cause it
to perform inaccurately or fail.
■ If the Rad-8 fails any part of the setup procedures or leakage tests, remove the device from operation
until qualifi ed service personnel have corrected the situation.
■ If a sensor is damaged in any way, discontinue use immediately.
■ Disposal of product - Comply with local laws in the disposal of the device and/or its accessories.
■ The Rad-8 can be used during defi brillation, 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.
■ A functional tester cannot be utilized to assess the accuracy of the Pulse Oximeter or any sensors.
■ Ensure the speaker is not covered or the device is not placed face-down on bedding or
other sound absorbing surface.
■ To protect against injury from electric shock, follow the directions below:
■ Avoid placing the device on surfaces with visible liquid spills.
■ Do not soak or immerse the device in liquids.
■ Always turn off and disconnect the power cord from the AC power supply before cleaning
the device.
■ Use cleaning solutions sparingly.
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