User's Manual

Rad-87 Pulse CO-Oximeter Operator’s Manual
iii
■ Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO
2
measurements.
■ Elevated levels of Total Bilirubin may lead to inaccurate SpO
2
, SpMet
®
, SpCO, SpHb
®
and SpOC™
measurements.
■ Motion artifact may lead to inaccurate SpMet, SpCO, SpHb and SpOC m
easurements.
■ Very low arterial Oxygen Saturation (SpO
2
) levels may cause inaccurate SpCO and SpMet measurements.
■ Severe anemia may cause erroneous SpO
2
and SpOC readings.
■ Hemoglobin synthesis disorders may cause erroneous SpHb readings.
■ Do not use the Rad-87 or sensors during magnetic resonance imaging (MRI) scanning. Induced current
could potentially cause burns. The Rad-87 may affect the MRI image and the MRI device may affect the
accuracy of the Pulse CO-Oximetry parameters and measurements.
■ If using Rad-87 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
instrument might read zero for the duration of the
active irradiation period.
■ For home use, ensure that the Rad-87’s 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-87 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-87 where the controls can be changed by the patient.
■ Do not place the Rad-87's face against a surface. This will cause the alarm to be muffl ed.
■ Do not place the Rad-87 on electrical equipment that may affect the Pulse CO-Oximeter, preventing it from
working properly.
■ Do not expose the Rad-87 to excessive moisture such as direct exposure to rain. Excessive moisture can
cause the
instrument to perform inaccurately or fail.
■ Do not place containers with liquids on or near the Rad-87. Liquids spilled on the
instrument may cause it to
perform inaccurately or fail.
■ If the Rad-87 fails any part of the setup procedures or leakage tests, remove the
instrument from operation
until qualifi ed service personnel have corrected the situation.
■ Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
■
Do not monitor more than a single patient at a time on the Rad-87.
■ Disposal of product - Comply with local laws in the disposal of the instrument and/or its accessories.
■ The Rad-87 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, Medical Device Directive 93/42/EEC and Part 15, FCC Rules/USA.
■ This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
■ 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
Safety Information, Warnings, Cautions and Notes, continued