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9
Masimo
Safety Information, Warnings and
Cautions
The Rad-5
®
/5v
®
Pulse Oximeter software program is designed to minimize the possibility of
hazards from errors by following sound engineering design processes, Risk Analysis and
Software Validation.
Safety Warnings and Cautions
WARNING:
Electric shock hazard. Do not open the Rad-5/5v cover except to replace the
batteries. Only a qualified operator may perform maintenance procedures specifically
described in this manual. Refer servicing to Masimo for repair of this equipment.
WARNING:
Do not use Rad-5/5v if it appears or is suspected to be damaged. Damage to the
device can result in exposed electrical circuits that may cause patient harm.
WARNING:
Do not adjust, repair, open, disassemble, or modify the Rad-5/5v. Damage to the
device may result in degraded performance and/or patient injury.
WARNING:
Do not start or operate the Rad-5/5v unless the setup was verified to be correct.
Improper set-up of this device may result in degraded performance and/or patient injury.
WARNING:
As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.
WARNING:
Do not place the Rad-5/5v or accessories in any position that might cause it to
fall on the patient. Do not lift the Rad-5/5v by the patient cable.
WARNING:
Explosion hazard. Do not use the Rad-5/5v in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
WARNING:
Only use Masimo authorized devices with Rad-5/5v. Using unauthorized devices
with Rad-5/5v may result in damage to the device and/or patient injury.
WARNING:
All sensors and cables are designed for use with specific devices. Verify the
compatibility of the device, cable, and sensor before use; otherwise degraded performance
and/or patient injury can result.
WARNING:
Do not use the Rad-5/5v or oximetry sensors during magnetic resonance
imaging (MRI) scanning. Induced current could potentially cause burns. The Rad-5/5v may
affect the MRI image, and the MRI unit may affect the accuracy of the oximetry
measurements.
WARNING:
Rad-5/5v may be used during defibrillation. However, to reduce the risk of
electric shock, the operator should not touch the Rad-5/5v during defibrillation.
WARNING:
To protect against electrical shock injury, follow the directions below:
Avoid placing the device on surfaces with visible liquid spills.
Do not soak or immerse the device in liquids.
Do not attempt to sterilize the device.
Use cleaning solutions only as instructed in this Operator's Manual.
Do not attempt to clean the Rad-5/5v while monitoring patient.