Safety Information, Warnings And Cautions; Safety Warnings And Cautions; Performance Warnings And Cautions - Masimo UniView Operator's Manual

Safety Information, Warnings and Cautions

Note: Please refer to the Operator's Manual or Directions For Use for UniView host device.

Safety Warnings and Cautions

WARNING: Do not adjust, repair, open, disassemble, or physically modify the UniView host device. Injury to personnel or equipment damage could occur.
Return the UniView host device for servicing.
WARNING: If UniView host device fails any part of the setup procedures or electrical safety tests, remove the device from operation until qualified service
personnel have corrected the situation.
WARNING: Do not place the UniView host device where it may be accessible by patients.
WARNING: Do not use the UniView host device if it appears or is suspected to be wet or damaged.
WARNING: Do not use unauthorized devices with UniView. Possible loss of performance and/or patient injury may result.
WARNING: Do not place the UniView host device in any position that might cause it to fall on the patient.
WARNING: Do not use UniView in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched
environments or nitrous oxide to avoid risk of explosion.
WARNING: UniView host device should only be used in clinical environments in which it is approved to prevent patient injury or damage.
WARNING: To protect against injury, follow the directions below:
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Avoid placing the host device or accessories on surfaces with visible liquid spills.
•
Do not soak or immerse the host device in liquids.
•
Use cleaning solutions only as instructed in this operator's manual.

Performance Warnings and Cautions

WARNING: UniView does not generate or manage audible alarms. The connected device's alarms, used in conjunction with clinical signs and symptoms,
are the primary sources for determining that an alarm condition exists.
WARNING: UniView may be used during defibrillation. However, to reduce the risk of electric shock, the operator should not touch the UniView during
defibrillation.
WARNING: Do not use the UniView during magnetic resonance imaging (MRI) or in an MRI environment.
CAUTION: UniView is intended to be a supplemental display. Medical decisions should be made using data from the primary display of a device in
conjunction with clinical signs and symptoms.
CAUTION: UniView is intended to operate across the facility's network. Unanticipated failure or alteration of network components (including but not
limited to: disconnection or malfunctioning of a networking device/switch/router/ethernet cable) may result in loss of connectivity of UniView to other
hospital systems. Altering or making changes to the hospital network should be done with proper knowledge.
CAUTION: The Quality of Service (QoS) of the connectivity to the Point-of-Care (PoC) devices may be affected by:
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Network failure
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Increased number of connected devices on the network
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Modifications to the network
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Presence of devices provided with radio transmitters
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Improper network configuration and/or on PoC
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Signal priorities of the network
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Latency
CAUTION: Network performance may be affected by changes in the network including the addition of additional network devices.
CAUTION: Host device performance may be affected by changes in the host device software settings or operating system updates.
CAUTION: PoC performance may be affected by changes in the PoC software settings or updates.
CAUTION: To prevent tampering and ensure security, follow the directions below:
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UniView should be located with responsible personnel
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Unauthorized changes should not be made to UniView
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