Operator's Manual

Rad-97 Safety Information, Warnings and Cautions
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instruments prior to clinical decision making to completely understand the patient’s
condition.
WARNING: Rad-97 is not an apnea monitor.
WARNING: Rad-97 should not be used as a replacement or substitute for ECG-based
arrhythmia analysis.
WARNING: Rad-97 may be used during defibrillation. This may affect the accuracy or
availability of the parameters and measurements.
WARNING: Rad-97 may be used during electrocautery. This may affect the accuracy or
availability of the parameters and measurements.
WARNING: Always check that speaker is functional prior to use.
WARNING: Avoid placing Rad-97 against a surface that may cause the alarm to be muffled.
This may result in the inability to detect the audible alarms.
WARNING: Rad-97 may not fully charge in a high ambient temperature environment.
WARNING: Properly apply sensors according to sensor's directions for use. Misapplied sensor
or sensors that become partially dislodged may cause no or incorrect readings.
WARNING: Select a well perfused site for monitoring, very low perfusion at the monitored site
may result in no or incorrect readings.
WARNING: Do not use Rad-97 on patients that have been injected with dyes or any
substance containing dyes, the change usual blood pigmentation may cause no or incorrect
readings.
WARNING: Display parameter may not be accurate when a low SIQ message is provided.
Clinicians should consider additional information to supplement values to completely
understand the patient’s condition.
WARNING: If SpO
2
values indicate hypoxemia, a laboratory blood sample should be taken to
confirm the patient’s condition.
WARNING: SpO
2
is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
WARNING: Optical, pleth-based measurements (e.g. SpO
2
, SpHb, SpOC, SpMet, SpCO, RRp,
and ORi) can be affected by the following:
• Improper sensor application or use of incorrect sensor.
• Blood pressure cuff applied to the same arm as the sensor site.
• Intravascular dyes such as indocyanine green or methylene blue.
• Venous congestion.
• Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg
position).
• Abnormal pulse rhythms due to physiological conditions or induced through
external factors (e.g. cardiac arrhythmias, intra-aortic balloon, etc.).
• Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
• Moisture, birthmarks, skin discoloration, nail aberration, deformed fingers, or
foreign objects in the light path.
• Elevated levels of bilirubin.