User's Manual

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Safety Information, Warnings, and
Cautions
The following section lists warnings, caution, notes, and safety information.
The Radical-7 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.
The Radical-7 is to be operated by qualified personnel only. The manual, accessories,
directions for use, all precautionary information, and specifications should be read before use.
Always use the Radical-7 precisely in accordance with the directions in this manual,
including finger selection, finger alignment in the sensor, and subject behavior during
testing. Failure to follow all of the directions in this manual could lead to inaccurate
measurements.
Caution
For SpHb, the Radical-7 should be considered an early warning device. Blood
samples should be analyzed by laboratory instruments prior to clinical
decision making to completely understand the patient’s condition.
Caution
Variation in hemoglobin measurements may be profound and may be affected
by sample type, body positioning, as well as other physiological conditions.
As with most hemoglobin tests, Radical-
7 test results should be scrutinized in
light of a specific patient’s condition. Any results exhibiting inconsistency
with the patient’s clinical status should be repeated and/or supplemented
with additional test data.
Parameter Related Safety Information, Warnings, and
Cautions
This section contains parameter related safety information.
Warning
Interfering Substances: Dyes, or any substance containing dyes, that change
usual blood pigmentation may cause erroneous readings.
Warning
SpO2,
SpCO, SpMet, and SpHb are empirically calibrated in healthy adult
volunteers with normal levels of carboxyhemoglobin (COHb) and
methemoglobin (MetHb).