Rad-67
Safety Information, Warnings and Cautions
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12
Masimo
CAUTION:
To ensure patient electrical isolation, all external device connections to the
output interface port must be done using only authorized data cables.
Note:
Disconnect the device from AC mains by unplugging the AC power supply from the
Rad-67.
Note:
Use and store the Rad-67 in accordance with specifications. See the Specifications
section in this manual.
Performance Warnings and Cautions
WARNING:
Rad-67 is intended for spot-check monitoring only, no physiological alarms are
provided.
WARNING:
Rad-67 should not be used as the sole basis for medical decisions. It must be
used in conjunction with clinical signs and symptoms.
WARNING:
Do not utilize SpHb spot-check measurements as the sole basis for clinical
decisions on blood transfusions. The SpHb spot-check accuracy range does not include
values below 8 g/dL, which may be important for determining the need for transfusions.
WARNING:
If any measurement seems questionable, first check the patient’s vital signs by
alternate means and then check Rad-67 for proper functioning.
WARNING:
SpHb is not intended for use in pediatrics, pregnant patients, and patients with
renal disease.
WARNING:
Variation in hemoglobin measurements may be profound and may be affected
by sample type, body positioning, as well as other physiological conditions. Any results
exhibiting inconsistency with the patient's clinical status should be repeated and/or
supplemented with additional data. Blood samples should be analyzed by laboratory
instruments prior to clinical decision making to completely understand the patient’s
condition.
WARNING:
Rad-67 should not be used as a replacement or substitute for ECG-based
arrhythmia analysis.
WARNING:
Rad-67 may be used during defibrillation. This may affect the accuracy or
availability of the parameters and measurements.
WARNING:
Rad-67 may be used during electrocautery. This may affect the accuracy or
availability of the parameters and measurements.
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-67 on patients that have been injected with dyes or any
substance containing dyes, the change in usual blood pigmentation may cause no or
incorrect readings.
WARNING:
Displayed parameter(s) 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.
