User's Manual

Radius-7 Safety Information, Warnings and Cautions
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WARNING: To ensure safety, avoid placing anything on the device during operation.
WARNING: As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.
WARNING: The Armband site must be checked frequently or per clinical protocol to ensure
adequate securement, circulation and skin integrity.
WARNING: Armbands applied too tightly or that become tight due to edema will cause
inaccurate readings and can cause pressure injury.
WARNING: Discontinue and dispose of Armband if it appears to be stained or becomes
excessively moist to minimize risk of skin irritation.
CAUTION: Electrical Shock Hazard: Do not place the Battery Charger of Radius-7 on or near
the patient. Injury to patient could occur.
Note: Use and store the Radius-7 in accordance with specifications. See the Specifications
section in this manual.
Performance Warnings and Cautions
WARNING: Radius-7 is not an apnea monitor.
WARNING: Radius-7 should not be used as a replacement or substitute for ECG-based
arrhythmia analysis.
WARNING: Radius-7 may be used during defibrillation, but this may affect the accuracy or
availability of the parameters and measurements.
WARNING: Do not use during electrocautery. This may affect the accuracy or availability of
the parameters and measurements.
WARNING: Radius-7 is intended only as an adjunct device in patient assessment. It should
not be used as the sole basis for diagnosis or therapy decisions. It must be used in
conjunction with clinical signs and symptoms.
WARNING: If any measurement seems questionable, first check the patient’s vital signs by
alternate means and then check Radius-7 for proper functioning.
WARNING: When the Radius-7 is connected to Root, all audible alarms will be provided on
the Root.
WARNING: Always pair Radius-7 with Root.
WARNING: Avoid placing Radius-7 against a surface that may cause the alarm to be muffled.
WARNING: Misapplied sensor or sensors that become partially dislodged may cause either
over or under reading of actual arterial oxygen saturation.
WARNING: With very low perfusion at the monitored site, the reading may read lower than
core arterial oxygen saturation.
WARNING: Venous congestion may cause under reading of actual arterial oxygen saturation.
Therefore, assure proper venous outflow from monitored site.
WARNING: Excessive venous pulsations may cause erroneous low SpO2 readings (e.g.
tricuspid valve regurgitation,Trendelenburg position).
WARNING: Interfering Substances: Dyes or any substance containing dyes, that change usual
blood pigmentation may cause erroneous readings.