GE Portrait Hub01 Manuals

Manuals and User Guides for GE Portrait Hub01. We have 1 GE Portrait Hub01 manual available for free PDF download: User Manual

GE Portrait Hub01 User Manual (198 pages)

Mobile Monitoring Solution

Brand: GE | Category: Medical Equipment | Size: 5.88 MB

Table of Contents
3
Legal Manufacturer Information
13
Manufacturer Information
13
Standards
15
Standards Compliance
15
Iec 60601-1
15
Spo 2 Standards Compliance
16
Impedance Respiration Standards Compliance
16
Introduction to this Manual
17
Manual Intended Use
17
Intended Audience of this Manual
17
Training Requirements
18
Manual Conventions
18
Naming Conventions
18
Illustrations and Names
19
Ordering Manuals
19
Accessing Manuals Online
19
Accessing Third Party Software Notices
19
Product Availability
20
Trademarks
20
Third Party Trademarks
20
Manufacturer Responsibility
20
Related Manuals
20
Safety and Intended Use
21
Safety Message Signal Words
21
Safety Symbols
21
Reporting of Serious Incidents
22
Danger Safety Messages
22
Warnings
22
System Warnings
22
EMC Warnings
24
Operation Warnings
25
Defibrillation Warnings
27
Alarm Warnings
27
Accessories Warnings
28
Battery Warnings
28
Care Warnings
28
Respiration Warnings
29
Spo Warnings
29
Cautions
30
Alarm Cautions
30
System Cautions
30
Operation Cautions
30
Disposal Cautions
31
Respiration Cautions
31
Intended Use Statements
31
Portrait Mobile Monitoring Solution Intended Use
31
Equipment Markings
34
Unique Device Identifier (UDI)
39
CE Marking Application Year
39
System Description
41
Short Description of the System
41
Clinical Benefits
41
System Components
42
Core Services Overview
43
Central Viewer and Alarming Unit Overview
43
Hub and Sensors Overview
45
System Installation Points to Note
50
Graphical User Interface
51
User Interface Indicators
51
Central Viewer
53
Multiple Patient View
53
Single Patient View
53
Hub
55
Hub Screen Elements
55
Hub Locked View
56
Hub Passcode View
58
Hub Patient List
58
Hub Patient Details
58
Hub LIVE View
59
Hub Detailed View
60
Hub Menu
61
Managing Patients and Monitoring
63
Admitting a Patient
63
Editing Patient Demographics
64
Powering on the Hub
65
Unlocking the Hub Screen
65
Selecting a Patient
66
Attaching Measurement Devices to the Patient
67
Pairing the First Sensor
67
Pairing Another Sensor
68
Unpairing a Sensor
69
Moving a Patient to a New Bed
69
Using the Hub Pouch
69
Unassigning the Patient from the Hub
70
Shutting down the Hub
70
Discharging a Patient
71
Battery Management
73
Safety Precautions
73
Connecting and Disconnecting Sensor Batteries
73
LED Indicators on Sensor Batteries
73
LED Indicators on the Charger
75
About Hub and Sensor Batteries
75
Charging Batteries
76
Charging an Empty Sensor Battery
77
Checking the Hub Battery Status
77
Checking the Status of a Sensor Battery
78
Changing a Sensor Battery
78
About the Lithium-Ion Battery
79
Battery Recycling
79
Hub and Modes
81
About Modes
81
Selecting the Use Mode
81
Alarms
83
Safety Precautions
83
Alarm Conditions
83
Alarm Priority Levels
83
Active Alarms
83
Alarm Signals and User Position
84
Visual Alarm Indicators
84
About Alarm Messages
85
Auditory Alarm Indicators
85
Alarm Settings on the Central Viewer
85
Adjusting Alarm Limit Settings
85
Adjusting Alarm Volume on the Central Viewer
86
Adjusting Alarm Volume on the Hub
86
Alarm Acknowledgement
87
Acknowledging Alarms
87
Reactivating Alarms
88
Checking Alarm Function
88
Alarms During Power Cycle
88
Alarm Logs
89
Parameter Filtering and Signal Quality
91
Parameter Filtering
91
Signal Quality Indicator (SQI)
91
Impedance Respiration
93
Safety Precautions
93
Portrait
93
Intended Use
93
Portrait TM RR Electrode Patch (Portrait RRP01) Intended Use
93
Respiration Measurement Limitations
94
Respiration Measurement Description
94
Respiration Measurement Practicalities
95
Respiration Points to Note
95
Respiration Measurement Setup
96
Preparing the Patient's Electrode Sites
96
Starting the Respiration Measurement
96
Checking the Respiration Measurement
98
Removing Respiration Electrodes
98
Troubleshooting the Measurement
98
Pulse Oximetry and Pulse Rate
99
Safety Precautions
99
Portrait Spo2
99
Intended Use
99
Wearable Pulse Oximetry Sensor
100
Portrait
100
Spo 2 and Pulse Rate Measurement Limitations
100
Spo 2 Measurement Description
100
Spo₂ Measurement Quality
101
Spo 2 and Pulse Rate Measurement Interference
101
Spo 2 Waveform Quality
101
Spo 2 and Pulse Rate Measurement Practicalities
102
Spo 2 and Pulse Rate Points to Note
102
Spo 2 and Pulse Rate Measurement Setup
103
Preparing the Spo and Pulse Rate Connection
103
Starting the Spo and Pulse Rate Measurement
103
Checking the Spo 2 and Pulse Rate Measurement
105
Troubleshooting the Measurement
106
Spo 2 Functional Testers
106
Trends
107
About Trends on the Central Viewer
107
Viewing Trends on the Central Viewer
107
Using the Trend Cursor on the Central Viewer
108
About Trends on the Hub
109
Viewing Trends on the Hub
109
Using the Trend Cursor on the Hub
110
Cleaning, Disinfection, and Care
113
Safety Precautions
113
Cleaning, Disinfection, and Care Overview
113
Visual Inspection, Cleaning, and Disinfection Frequency
113
Cleaning
114
General Cleaning Instructions
114
Cleaning Points to Note
114
Permitted Detergents
114
Cleaning Procedure for the Hub
115
Cleaning Procedure for the Respiration Sensor
117
Cleaning Procedure for the Spo Sensors
119
Cleaning Procedure for Sensor Batteries
122
Cleaning Procedure for the Charger
124
Cleaning Procedure for the Alarming Unit
125
Disinfection
126
Disinfection Points to Note
126
Permitted Disinfectants
127
Disinfection Procedure
127
Care
128
Care Schedules
128
Periodic Maintenance
129
Daily Checks
129
Preventive Maintenance
129
About Service and Maintenance During Monitoring
129
Troubleshooting
131
Troubleshooting the Central Viewer
131
Troubleshooting the Hub
132
Troubleshooting the Respiration Measurement
134
Troubleshooting the Spo 2 and Pulse Rate Measurements
135
Alarm Messages
137
Alarms Related to the Respiration Rate Measurement
137
Alarms Related to the Spo 2 and Pulse Rate Measurement
139
Alarms Related to Device Issues
142
Technical Specifications
145
Design, Environmental, and Physical Specifications
145
FCC Information
145
Radio Equipment Directive (RED) Information
146
ISED Information
146
RF Exposure Information
146
Technical Specifications, Hub
147
Technical Specifications, Charger
147
Technical Specifications, Sensors
148
Technical Specifications, Sensor Batteries
148
Technical Specifications, Alarming Unit
149
Minimum Requirements, Central Viewer
149
Technical Specifications, EHL Platform
150
Alarm Specifications
151
Auditory Alarm Volume, IEC Tones
151
Audio Alarm Sound Tolerances
151
IEC Alarm Tone Sound Patterns
152
Auditory Information Signal Characteristics
152
Alarm Delay Specifications
152
Alarm Delay Specifications for Impedance Respiration Alarms
153
Alarm Delay Specifications for Spo 2 and PR Alarms
154
Alarm Delay Specifications for Technical Issues
154
Parameter Specifications
157
Spo 2 Displayed Saturation Values
157
Spo₂ Summary of Clinical Studies Used to Establish Accuracy Claims
157
Accuracy of Portrait TM Sensor Technology
157
Spo 2 Test Methods Used to Establish Accuracy Claims During Motion
157
Spo 2 Test Methods Used to Establish Accuracy Claims During Low Perfusion
158
Spo 2 Test Methods Used to Establish Pulse Rate Accuracy
158
Spo 2 Performance Specifications
158
Spo₂ Supplemental Analysis Graphs
159
Additional Accuracy Information for Portrait
159
TM Sensors
159
Impedance Respiration Performance Specifications
163
Abbreviations
165
List of Abbreviations
165
Skills Checklist
167
Safety
167
System Introduction
168
Graphical User Interface
168
Configuration
169
Managing Patients and Monitoring
169
Battery Management
170
Hub Modes
170
Alarms
171
Parameter Filtering and Signal Quality
171
Impedance Respiration
171
Pulse Oximetry and Pulse Rate
172
Trends
172
Cleaning, Disinfection, and Care
173
Quick Workflow Overview
175
Quick Workflow Instructions
175
Default Settings and Configuration
177
About Configuration Settings
177
Config UI Patient Default Profiles Configuration
177
Compatible Devices
183
Hub (HUB01) Compatibility
183
Spo 2 Sensor (Spo2 P-SA01, P-SP01) Compatibility
183
Spo 2 Sensor (P-SE01) Compatibility
184
Spo 2 Sensor (P-W01) Compatibility
184
Respiration Rate Sensor (P-RR01) Compatibility
184
Sensor Battery (SBT01) Compatibility
185
Bedside Charger (BCH01) Compatibility
185
Alarming Unit (CAU01) Compatibility
185
Mounts Compatibility
185
Supplies and Accessories
187
List of Supplies and Accessories
187
Electromagnetic Compatibility
189
Iec 60601-1-2
189
EMC Warnings
189
About EMC Disturbance
190
Essential Performance in EMC
190
Electromagnetic Emissions
191
Electromagnetic Immunity
191
Electromagnetic Immunity for RF
193
Recommended Separation Distances
194
Proximity Field Immunity Compliance
194
Applicable RF Receiver and Transmitter Specifications
196

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