Masimo UniView Operator's Manual

UniView™
Operator's Manual
Notice: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Masimo Corporation 52 Discovery Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com
Patents: www.masimo.com/patents.htm
Masimo®, ®, O3®, Radical-7®, Radius-7®, rainbow®, Root®, and SedLine® are federally registered trademarks of Masimo Corporation.
Iris Gateway™, ISA™, Patient SafetyNet™, Rad-97™, and UniView™ are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners.
The use of the trademark PATIENT SAFETYNET is under license from University Health System Consortium.
© 2018 Masimo Corporation
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Contents
About This Manual...................................................................................................................................................................................................................... 5
Product Description, Intended Use and Contraindications ........................................................................................................................................................ 7
Product Description ............................................................................................................................................................................................................... 7
Key Features ........................................................................................................................................................................................................................... 7
Intended Use ......................................................................................................................................................................................................................... 7
Contraindications .................................................................................................................................................................................................................. 7
Safety Information, Warnings and Cautions .............................................................................................................................................................................. 9
Safety Warnings and Cautions............................................................................................................................................................................................... 9
Performance Warnings and Cautions .................................................................................................................................................................................... 9
Cleaning and Service Warnings and Cautions..................................................................................................................................................................... 10
Compliance Warnings and Cautions ................................................................................................................................................................................... 10
Chapter 1: Description .............................................................................................................................................................................................................. 11
System Overview .................................................................................................................................................................................................................. 11
UniView Overview ................................................................................................................................................................................................................ 12
Chapter 2: Operation ................................................................................................................................................................................................................ 13
Opening the UniView Application ....................................................................................................................................................................................... 13
System Login ....................................................................................................................................................................................................................... 13
Selecting a Patient .............................................................................................................................................................................................................. 13
Selecting a Screen Layout ................................................................................................................................................................................................... 14
Visual Alarms Indicators ..................................................................................................................................................................................................... 20
Alarm Status Visualizer ....................................................................................................................................................................................................... 23
Changing Patients ............................................................................................................................................................................................................... 24
Advanced Features ............................................................................................................................................................................................................... 25
Chapter 3: Messages ................................................................................................................................................................................................................ 29
Messages .............................................................................................................................................................................................................................. 29
Chapter 4: Troubleshooting ...................................................................................................................................................................................................... 31
Troubleshooting UniView .................................................................................................................................................................................................... 31
Chapter 5: Specifications ........................................................................................................................................................................................................ 33
Compatible Masimo Systems ............................................................................................................................................................................................. 33
Symbols .............................................................................................................................................................................................................................. 33
Chapter 6: Warranty Information ............................................................................................................................................................................................ 35
Cleaning .............................................................................................................................................................................................................................. 35
Contacting Masimo ............................................................................................................................................................................................................. 35
Index ......................................................................................................................................................................................................................................... 37
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About This Manual

This manual explains how to set up and use UniView™. Important safety information relating to general use of UniView appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.
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Product Description, Intended Use and Contraindications

Product Description

UniView is a supplemental display of parameter data and alarm conditions received from Point-of-Care (PoC) devices connected to Masimo Systems (Patient SafetyNet or Iris Gateway).
The following PoC devices can display data on UniView via Patient SafetyNet or Iris Gateway Systems:
Third-party devices
Masimo devices

Key Features

UniView consists of the following components and/or features:
Ability to communicate over an IEEE 802.11 (2.4 & 5 GHz) wireless or hard wired network.
Ability to access parameter data from multiple PoC devices through Masimo Systems.
Ability to display supplemental visual alarm conditions at different alarm priorities for parameter data received through a Masimo System.
Multiple screen layout options:
Overview Layout (See Overview Layout on page 15)
Hemodynamics Layout (See Hemodynamics Layout on page 17)
Oxygenation Layout (See Oxygenation Layout on page 18)
Sedation Layout (See Sedation Layout on page 19)

Intended Use

UniView is a software application, intended to provide supplemental display of patient monitoring data, and run on off-the-shelf hardware devices. UniView communicates with networked devices in healthcare environments.

Contraindications

There are no contraindications.
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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:
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:
Network failure
Increased number of connected devices on the network
Modifications to the network
Presence of devices provided with radio transmitters
Improper network configuration and/or on PoC
Signal priorities of the network
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:
UniView should be located with responsible personnel
Unauthorized changes should not be made to UniView
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UniView Safety Information, Warnings and Cautions
CAUTION: Do not place the UniView host device on or near electrical equipment that may affect the device and prevent it from working properly.
CAUTION: To ensure proper system operation, always verify successful connection between PoC devices and UniView.
CAUTION: To ensure the host device receives enough signal strength, verify the host device is within range of the hospital network.
CAUTION: To prevent unauthorized access to patient information, enable security measures as part of the host device.
Note: Patient monitoring data displayed on the UniView is based upon the time stamp provide by the PoC device. UniView times may not be
synchronized to the PoC device.

Cleaning and Service Warnings and Cautions

WARNING: Do not autoclave, pressure sterilize, or gas sterilize the UniView host device.
WARNING: Clean and only use as instructed in the Operator's Manual for the UniView host device.
Note: Modifications to UniView's settings, and those of any components connected to UniView, should be made by qualified personnel only.
Note: UniView host device installation must be completed by Masimo or an authorized service personnel.

Compliance Warnings and Cautions

WARNING: Do not attempt to repair or modify any part of UniView host device doing so may void the warranty or the authorization to use the UniView host device.
WARNING: The software settings of the UniView host device should be completed by authorized personnel only.
WARNING: Disposal of product - Comply with local laws in the disposal of UniView host device and/or its accessories.
WARNING: When using devices with wireless features, consideration should be taken to local government frequency allocations and technical parameters
to minimize the possibility of interference to/from other wireless devices.
WARNING: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems.
Note: Refer to the UniView host device's Operator's Manual or Directions For Use for UniView for FCC compliance information before use.
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facility. See Adding a System on page 25.
The UniView application is pre-installed on the host device and compatible only with an Android operating system.

Chapter 1: Description

System Overview

The diagram below describes how UniView receives patient data from PoC devices. The PoC devices, Masimo System, and UniView host device must be configured to the same hospital network.
Ref Component Description
Point-of-Care (PoC)
1
2 Hospital Network
3 Masimo System
4 UniView
Devices
A device that provides bedside patient monitoring.
IEEE 802.11 (2.4 & 5 GHz) wireless or hard wired network communication
PoC devices, Masimo System, and host device are configured to the same hospital network.
Note: Refer to the appropriate device operator's manual for network configuration instructions.
The Masimo System is a Patient SafetyNet/Iris Gateway server.
The Masimo System receives patient data from PoC devices and sends patient data to UniView through a secured connection.
UniView displays patient data from one Masimo System. To view a different Masimo System, see Changing Systems on page 27.
Multiple Masimo Systems can be added to UniView to view patient data from different care stations in a hospital
UniView requires a host device and display.
The host device is a computer or mobile device with an Android operating system.
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