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baxter Starling User Manual
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5-8
Starling
Monitor - User Guide
Patient Preparat
ion
Figure
5-5
CORR
ECT Orientation of Sensors
Figure
5-6
INCORRECT Orientation of Sensor
s
Orientation mark
(outer -top)
Orientation mark
(outer -bottom)
Orientation mark
(outer -bottom)
Orientation mark
(outer - top)
143
145
Table of Contents
Default Chapter
3
Copyright Notice
3
Preface
3
Trademarks
3
Intended Use
4
Operational Use of the Starling Monitor
4
Responsibility of the Manufacturer
5
Conventions Used in this Guide
6
Terms and Abbreviations
8
Table of Contents
9
Chapter 1 - Safety Information
29
General Safety Considerations
29
Safety Checks before Using the System
29
Prescription Notice
30
Equipment Classification
30
Compliance with International Standards
30
Table 1-1 Compliance with International Standards
30
Electrical Safety
31
Electrical Requirements
31
Grounding
32
Electrical Shock Hazard
32
Protection against Ingress of Liquids
33
Electromagnetic Compatibility (EMC)
33
Biocompatibility
33
System Safety Labels
34
Starling Monitor Safety Label
34
Figure 1-1 Starling System - Safety Rating and Manufacturer Label
34
Figure 1-2 Starling Monitor with Spo2 - Safety Rating and Manufacturer Label
35
Table 1-2 Starling System - Safety Rating and Manufacturer Label
35
Location of Safety Labels on System Components
38
Figure 1-3 Starling System Safety Label - Location on Side Panel
38
Label on Monitor Side Panel
38
Safety Labels on Accessories and Disposables
39
Figure 1-4 Disposable Starling Sensors - One Set
39
Label on Pack of Disposable Starling Sensors
39
Table 1-3 Disposable Starling Sensors - Symbol Descriptions
40
System Software
41
Guidelines for Safe Handling of the Starling Monitor
42
Environmental Requirements
43
Table 1-4 Recommended Environmental Conditions - Starling Monitor
43
Table 1-5 Recommended Temperature Conditions - Starling Sensors
43
Space and Positioning
44
Patient Safety and Handling Guidelines
45
Infection Control
45
Electricity Power Failure
45
Battery Capacity Low
45
Use of Accessories and Disposables
46
Disposable Starling Sensors
46
Data Handling
48
Data Export
48
Cybersecurity Guidelines
48
HIPPA Compliance
48
Data Storage
49
Chapter 2 - Starling Monitoring System
51
Overview
51
Indications for Use
53
Limitations of Use
54
Clinical Situations Potentially Affecting Starling Algorithm Accuracy or Performance
54
Patient Populations in Which the Starling Monitor Has Not Been Tested
55
Theory of Operation
56
Figure 2-1 Application of Starling Sensors
57
Figure 2-2 Baseline Phase Shift
58
Figure 2-3 Increase in Phase Shift
58
Figure 2-4 Stroke Volume Increase >10% - Indicates Patient Is Fluid Responsive
59
Figure 2-5 Stroke Volume Increase <10% - Indicates Patient Is Not Fluid Responsive
59
System Configuration
60
Starling Monitor
60
Figure 2-6 Starling Monitor - Front View (Operator Panel)
61
Figure 2-7 Starling Monitor - Rear View
62
Figure 2-8 Starling Monitor - Side and Top Views
63
Operator Panel
64
Display Control Knob
64
Touch Screen - LED Display
64
Back Button
65
Buttons
65
Main Menu Button
65
Power on Button
65
Table 2-1 Power on Button - Power Status Indicators
65
Internal Chargeable Batteries
66
Battery Status Indicators
66
Table 2-2 Battery Status Indicators
66
Battery Power Mode
67
Accessories - Standard
68
AC Power Cable
68
Figure 2-9 Starling Patient Cable
68
Starling Patient Cable
68
Figure 2-10 NIBP Cuff with Air Hose
69
NIBP Module
69
User Guide CD
70
Disposable Starling Sensors
71
Figure 2-11 Disposable Starling Sensors - Single Set Contents
72
Accessories - Optional
73
Spo 2 Module
73
Figure 2-12 Spo Cable
74
Figure 2-13 Starling Monitor Mounted on Roll Stand
75
Roll Stand
75
Figure 2-14 Starling IV Pole Mount Connector
76
Starling IV Pole Mount Connector
76
Figure 2-15 Starling Carry Bag
77
Starling Carry Bag
77
Lift
78
Operating Modes
79
Startup Mode
79
Idle Mode
79
Browsing Mode
79
Monitoring Mode
79
Pause Mode
80
Clinical Workflow
81
Chapter 5 - Patient Monitoring
81
Adding a New Patient
81
Patient Preparation
81
Attaching Starling Sensors
81
Viewing an Active Monitoring Session
81
Chapter 3 - Starling Monitor Display
83
Introduction to the Touch Screen Display and Controls
83
Main Screens and Controls
83
Navigation and Display Options
83
Using the Display Control Knob
84
Messages and Pop-Up Windows
84
Quick Access Menu
85
Home Screen
86
Figure 3-2 Home Screen - Default Display after Startup
86
Main Menu
87
Controls Toolbar
91
Help Menu
92
Trends Area
93
Figure 3-6 Scrolling the Trends Display
94
Viewing the Trends Display
94
Figure 3-7 SV Parameter Showing SV Average Values
95
Controlling the Trends Display
96
Figure 3-8 Trends Area - Collapsed and Full-Width Views
97
Figure 3-9 Trends Area - Collapsed and Full-Screen Views
98
Figure 3-10 Trends Area Showing Markers
99
Trends Area Markers
99
Adding an Event to the Trends Area
100
Real-Time Values
101
Controlling the Real-Time Values Display
102
Figure 3-13 Parameter Values Area - Collapsed and Full-With Views
102
Figure 3-14 Parameter Values Area - Collapsed and Full-Screen Views
103
Display Window
104
Clinical Range
104
Setting or Adjusting Clinical Ranges
104
Figure 3-15 Display Window - Clinical Range Tab
104
Figure 3-16 Parameter Value Warning - Exceeds Maximum Limit
105
Figure 3-17 Display Window - Waveforms Tab
105
Waveforms
105
Dynamic Assessment
106
Figure 3-18 Display Window - Dynamic Assessment Tab - no Previous Test
106
Figure 3-19 Display Window - Dynamic Assessment Tab - Latest Test
106
Figure 3-20 Display Window - Numeric Tab
107
Numeric
107
Adding an Event to the Numeric Display
108
Changing the Home Screen Display Layout
109
Figure 3-22 Change View - Predefined Home Screen Layout Options
109
Patient Management Window
110
Figure 3-23 Patient Management Window
110
Function Buttons
111
Table 3-2 Patient Management Window - Button Functions
111
Figure 3-24 Patient Management Window - Selected Patient File
112
Selected Patient File
112
Deleting a Patient File
113
Figure 3-25 Warning Message - Patient File and All Sessions in File will be Deleted
113
Session Browser Window
114
Figure 3-26 Session Browser Window - Default Display
114
Using History Mode
116
Viewing Trends in History Mode
116
Figure 3-27 Trends Area - Full Screen View Showing Sessions Indicator
117
Viewing Dynamic Assessment Test Results in History Mode
118
Figure 3-28 Viewing Multiple Dynamic Assessment Test Results in History Mode
118
Viewing Numeric Data in History Mode
120
Figure 3-29 Viewing Numeric Data in History Mode
120
Chapter 4 - System Preparation, Startup and Shutdown
123
System Preparation - Overview
123
First-Time Use
123
Positioning the Starling Monitor
124
Recommended Guidelines for Monitor Positioning
124
Mounting the Monitor on the Roll Stand
125
Figure 4-1 Mounting the Monitor on the Roll Stand
125
Figure 4-2 Starling Monitor Secured on the Roll Stand
126
Attaching the Starling IV Pole Mount Connector
127
Figure 4-3 Starling IV Pole Mount Connector Attached to Monitor
127
Mounting the Monitor on a Table Top
128
Connecting the AC Power Cable
129
Figure 4-4 Connecting the AC Power Cable to the Monitor
129
System Startup Procedure
130
Turning on Power to the Monitor
130
Connecting the Starling Patient Cable
132
Figure 4-7 Connecting the Starling Patient Cable
132
Connecting the NIBP Air Hose to the Monitor
133
Figure 4-8 Connecting the NIBP Air Hose
133
Connecting the Spo Cable to the Monitor
134
Figure 4-9 Connecting the Spo
134
System Shutdown Procedure
135
Turning off Power to the Starling Monitor
135
Disconnecting Cables
136
Cleaning the Monitor and Accessories
136
Storage When Not in Use
136
Figure 5-2 Enter New Patient Details
139
Figure 5-4 Four Areas for Positioning of Starling Sensors
143
Figure 5-5 CORRECT Orientation of Sensors
144
Figure 5-6 INCORRECT Orientation of Sensors
144
Figure 5-7 Sensor Placement Window - Calibration in Progress
146
Figure 5-8 Sensor Placement - Error Display
147
Figure 5-9 Home Screen - Monitoring Session Initial Display
148
Figure 5-10 Monitoring Session in Progress
149
Figure 5-11 Clinical Ranges Dialog Box
150
Choosing a BP Source
151
Setting Internal NIBP Automatic Mode and Adjusting Time Interval
151
Figure 5-13 Setting Internal NIBP Time Interval
152
Figure 5-14 Time Indicator for Next Internal NIBP Measurement
152
Figure 5-15 Acquiring a Single NIBP Measurement
153
Using the Start Once Feature
153
Figure 5-16 Ending NIBP Measurement
154
Using the End NIBP Feature
154
Entering a Mean Arterial Pressure Measurement
155
Choosing an SPO 2 Source
156
Figure 5-18 Choosing an SPO
156
Entering an SPO 2 Measurement
157
Figure 5-20 Enter SPO
157
Entering an Hgb Measurement
158
Setting the Hgb Posting Period
159
Figure 5-22 Hgb Posting Period - Available Options
159
Adding an Event Manually
161
Figure 5-23 Events Dialog Box - Drugs Tab
161
Figure 5-26 Events Dialog Box - Events Tab
164
Figure 5-27 Events Dialog Box - Fluids Tab
165
Figure 5-28 Events Dialog Box - Other Tab
166
Table 5-1 Predefined Events - Available Options Listed Per Category
167
Setting Alerts
170
Figure 5-29 Setting Audible Alert to on
170
Responding to an Alert
171
Figure 5-30 Active Alert - Warning Message Displayed
171
Passive Leg Raise (PLR) Test
172
Fluid Bolus Challenge
172
Figure 5-31 Display Window - Dynamic Assessment Tab
172
Figure 5-32 Message Displayed Prior to Starting PLR Test
173
Figure 5-34 PLR Test - Baseline Measurement in Progress
175
Figure 5-36 PLR Test - Challenge in Progress
177
Figure 5-37 PLR Test Completed Successfully
178
Figure 5-38 Viewing PLR Test Results - Enlarged View
179
Figure 5-39 Viewing PLR Test Results - Enlarged View Page 2 (Showing Elapsed Time)
180
Figure 5-40 Viewing PLR Test Results - Enlarged View
181
Figure 5-41 Display Window - Dynamic Assessment Tab
182
Figure 5-42 Message Displayed Prior to Starting Bolus Test
182
Figure 5-43 Bolus Test - Baseline Measurement in Progress
184
Figure 5-44 Bolus Test - Measure SVI Change
184
Figure 5-45 Bolus Test - Challenge in Progress
185
Figure 5-46 Bolus Test Completed Successfully
186
Figure 5-47 Viewing Bolus Test Results - Enlarged View
187
Figure 5-48 Viewing Bolus Test Results - Enlarged View Page 2 (Showing Elapsed Time)
188
Explanation of Dynamic Assessment Test Results
189
Figure 5-49 Viewing Bolus Test Results - Enlarged View
189
Figure 5-50 Dynamic Assessment Tab - Latest Test Results
190
Test Results in Dynamic Assessment Window
190
Figure 5-51 Frank-Starling Curve - Interpretation of Stroke Volume Increase
191
Dynamic Assessment Test Results in Full Screen View
192
Figure 5-52 Dynamic Assessment Test Results - Full Screen View
192
Browsing Monitoring Session History
194
Figure 5-53 Patient Management Window
194
Figure 5-54 List of Monitoring Sessions for Selected Patient
195
Figure 5-55 Selected Monitoring Session Displayed in Session Browser Window
196
Saving a Screen Capture
197
Data Export
198
Figure 5-56 List of Monitoring Sessions for Selected Patient
198
Exporting a Single Monitoring Session
201
Completion of Patient Monitoring
204
Stop Monitoring Session
204
Removing the Starling Sensors
205
Exporting Report Data
205
Cleaning the Starling Monitor
205
Chapter 6 - Care and Maintenance
207
General Care and Maintenance Guidelines
207
Cleaning and Disinfecting the Starling Monitor
207
Cleaning the LED Display
207
Cleaning the Roll Stand
211
Other Optional Accessories
211
Starling IV Pole Mount Connector
211
Storage When Not in Use
211
Touch Screen Calibration
212
Fuse Replacement Procedure
216
Battery Replacement
218
Software Upgrade
218
Service Information
219
HIPPA Compliance
219
Appendix A - Troubleshooting Guide
221
General Troubleshooting Guidelines
221
Error Messages
221
Dynamic Assessment Tests - Troubleshooting
221
Table A-1 Starling System Troubleshooting - Error Messages
222
Table A-2 Performing a PLR or Fluid Bolus Dynamic Assessment Test - Troubleshooting
226
Warning Messages
227
Table A-3 Starling System Troubleshooting - Warning Messages
227
Miscellaneous Issues
228
Table A-4 Starling System Troubleshooting - Miscellaneous Issues
228
Appendix B - System Specifications and Technical Data
233
System Performance Specifications and Accuracy
233
Monitored Parameters
233
Table B-1 Normal Hemodynamic Parameters
233
Measurements Calculated and Displayed
234
Table B-2 Primary Measurements Calculated and Displayed
234
System Specifications
237
Starling Monitor
237
Starling System Specifications
237
Table B-3 Starling Monitor - Dimensions and Weight
237
Table B-4 Starling Monitor - LED Display
237
Table B-5 Starling Monitoring System Specifications
237
Technical Characteristics of Acquisition Module
239
Environmental Specifications
239
Starling Sensors - Specifications
239
Table B-6 Starling Sensors - Specifications
239
Technical Information
240
Electromagnetic Compatibility (EMC
240
Electromagnetic Emissions - Manufacturer's Declaration and Guidance
241
Table B-7 Guidance and Manufacturer's Declaration - Electromagnetic Emissions
241
Table B-8 Guidance and Manufacturer's Declaration - Electromagnetic Immunity
242
Recommended Separation Distances
244
Table B-10 Recommended Separation Distances
244
Immunity to Proximity Fields from RF Wireless Communications Equipment
245
Appendix C - Accessories: Specifications & Technical Data
247
NIBP Module
247
Terminology
247
Bpm
247
Mmhg
247
Oscillometry
247
Introduction
248
Populations that May Use the NIBP Function
248
Warnings and Precautions
249
Adverse Reactions
251
NIBP Cuff Selection and Placement
251
Table C-1 NIBP Cuff Sizes Available for Use with the Starling Monitor
253
Table C-2 NIBP Module Performance
254
Error Code List and Definitions
256
Table C-3 NIBP Module - Error Code List and Definitions
256
Spo 2 Module (Optional
261
NELL-1 Spo
261
Warnings and Precautions
262
Spo 2 Error Code List and Definitions
263
Connection of an External Patient Monitor
264
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baxter Starling Specifications
General
Brand
baxter
Model
Starling
Category
Medical Equipment
Language
English
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