Rad-97
Safety Information, Warnings and Cautions
www.masimo.com
15
Masimo
Kite
WARNING:
Do not adjust, repair, open, disassemble, or physically modify the Kite host
device. Injury to personnel or equipment damage could occur. Return the Kite host device for
servicing.
Performance Warnings and Cautions
WARNING:
Rad-97 should not be used as the sole basis for medical decisions. It must be used
in conjunction with clinical signs and symptoms.
WARNING:
The Rad-97 and Accessories are not intended to be used as the sole basis for
making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it
is intended to be used in conjunction with additional methods of assessing clinical signs and
symptoms.
WARNING:
If any measurement seems questionable, first check the patient’s vital signs by
alternate means and then check Rad-97 for proper functioning.
WARNING:
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 data, Rad-97 trend data should be scrutinized in light of a specific patient
condition. Any results exhibiting inconsistency with the patient's clinical status should be
repeated and/or supplemented with additional data.
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:
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.
