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INVOS 5100C
Covidien INVOS 5100C Manuals
Manuals and User Guides for Covidien INVOS 5100C. We have
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Covidien INVOS 5100C manuals available for free PDF download: Operator's Manual, Assembly Instructions
Covidien INVOS 5100C Operator's Manual (178 pages)
Regional Saturation Patient Monitoring System
Brand:
Covidien
| Category:
Medical Equipment
| Size: 22.18 MB
Table of Contents
Table of Contents
3
1 Introduction
13
Intended Audience
13
Key Terms
13
Labeling Symbols
13
Oximeter Enclosure
13
Monitor
15
Other Symbols
15
Warnings, Cautions, and Notes
17
Safety Symbols
17
General Warnings
17
Table 1-1. Safety Symbol Definitions
17
General Cautions
19
General Notes
21
How to Use this Manual
21
Use of the Product
22
Customer Inquiries
22
Service and Repair
22
INVOS™ System Warranty
23
Key Points
23
Limited Warranty and Disclaimer
23
Warranty Labor
24
Disclaimer of Consequential Damages
24
Failure of Product
25
Purpose of Product
25
Warnings about Unauthorized Repair
25
Who to Contact for Authorized Repair
25
2 Product Overview
27
Overview
27
Indications for Use
27
Contraindications
27
Brief Device Description
27
INVOS™ Adult Regional Saturation Sensor, Pediatric Regional Saturation Sensor, and Oxyalert Nirsensor
28
Principles of Operation
28
Figure 2-1. Disposable Sensors
28
3 Installation
31
Overview
31
Unpacking
31
Serial Numbers
32
Installation
32
Digital Output Port
33
Figure 3-1. Back Connections and Elements
33
VGA Output Port
34
Potential Equalization Connector
34
Alarm Speaker
34
Cooling Fan
34
AC Input and Fuse
34
USB Port
35
Accessories
35
Preamplifier
37
Figure 3-2. Side Connections
37
Figure 3-3. Preamplifiers, Reusable Sensor Cables, and Sensor Connections
38
Reusable Sensor Cable
39
Adult and Pediatric Regional Saturation Sensor Application
39
Sensor Preuse Check
39
Sensor Lot Number
39
Sensor Cerebral Site Selection
39
Sensor Somatic Site Selection
40
Patient Prep
40
Figure 3-4. Sensor Prep
40
Sensor Placement
41
Figure 3-5. Sensor Placement
41
Care of and Removing the Sensor
42
Infant/Neonatal Oxyalert Nirsensor Sensor Application
42
Oxyalert Nirsensor Preuse Check
42
Oxyalert Nirsensor Lot Number
43
Oxyalert Nirsensor Cerebral Site Selection
43
Oxyalert Nirsensor Somatic Site Selection
43
Patient Prep
43
Oxyalert Nirsensor Placement
43
Monitoring with the Oxyalert Nirsensor
44
Figure 3-6. Oxyalert Nirsensor Placements: Cerebral, Flank, and Abdominal Shown
44
Care of and Removing the Oxyalert Nirsensor
45
When INVOS™ System Is Part of a Medical Monitoring System
45
Quick Setup
47
Figure 4-1. Connecting the Preamplifier to the Monitor
47
Initial Setup
47
Overview
47
Figure 4-2. Connecting the Sensor Cable Connectors to the Preamplifier
48
Figure 4-3. Connecting the Sensors to the Sensor Cables
48
Figure 4-4. Connecting Optional Accessories
49
Screens
51
Overview
51
Figure 5-1. Welcome Screen
52
Start Screen, Navigation Bar, Key Panel and Software Version
52
Welcome Screen
52
Figure 5-2. Start Screen, Navigation Bar, Key Panel and Software Version
53
Figure 5-3. Patient Identifier Screen
54
Main Screen
54
Patient Identifier Screen
54
Figure 5-4. Main Screen Elements (Two-Channel Monitoring)
55
Figure 5-5. Main Screen (Four-Channel Monitoring)
56
Figure 5-6. User Configuration Screen
57
Figure 5-7. User Configuration Screen
57
User Configuration Screen
57
Event Mark List Screen
58
Figure 5-8. Event Mark List Screen (or Event Mark List)
58
Figure 5-10. Event Mark List Screen (Vascular Event Mark List)
59
Figure 5-9. Event Mark List Screen (ICU Event Mark List)
59
Baseline Reset Screen
60
Figure 5-11. Event Mark List Screen (NICU Event Mark List)
60
Channel Inactivity Screen
61
Figure 5-12. Baseline Reset Screen
61
Figure 5-13. Channel Inactivity Screen
61
Digital Output Format Selection Screen
62
Figure 5-14. RS-232 Digital Output Format Selection Screen (Two-Channel Monitoring)
62
Figure 5-15. RS-232 Digital Output Format Selection Screen (Four-Channel Monitoring)
62
Figure 5-16. Tabular Trends Screen-Run Function in Normal Mode
63
Figure 5-17. Tabular Trends Screen-Case Archive Function in Normal Mode
63
Tabular Trends Screen
63
Case Archive File List Screen
64
Figure 5-18. Tabular Trends Screen-Manual Set Baseline in Normal Mode
64
Table 5-1. Tabular Trends Line of Data Format
64
Figure 5-19. Case Archive File List Screen
65
Review Screen
65
Figure 5-20. Trend Graph Screen-Case Archive Function in Normal Mode
66
Figure 5-21. Trend Graph Screen-Run Function in Normal Mode
66
6 Operation
67
Overview
67
INVOS™ System Preuse Check
67
Operational Modes
67
Date, Time, and Patient Identifier Settings
68
Date
68
Time
69
Patient Identifier
70
Run Function (Patient Monitoring) in Normal Mode
71
Baseline Set and Status
72
Figure 6-1. INVOS™ System in Normal Mode with Low Alarm
72
Event Mark
75
Table 6-1. Event Codes and Descriptions for Operating Room
76
Table 6-2. Event Codes and Descriptions for Intensive Care Unit
77
Table 6-3. Event Codes and Descriptions for Vascular Application
78
Alarm Limits
79
Table 6-4. Event Codes and Descriptions for Neonatal Intensive Care Unit
79
Alarm Volume
82
Rso2 Scale
84
Time Scale in User Configuration Menu
85
USB Storage Rate
86
Event Mark List
87
Data Channel Labels
88
Color-Coded Data Channel Labels
88
Two- or Four-Channel Monitoring
89
Restore Defaults
90
Alarms and Status Messages
91
Figure 6-4. Technical Alarm Indicated
94
Table 6-5. Status Messages-Rso2 Value Displayed
96
Signal Strength Indicator (SSI)
98
Time Scale
99
Real-Time Review
99
Case Archive Function
101
Case Archive Function-Graphical Format
101
Case Archive Function-Tabular Trends Screen Format
102
7 Using the Monitor Ports
103
Overview
103
Using the VGA Port
103
Figure 7-1. VGA Video Connector Pin-Out
104
Table 7-1. VGA Video Connector Pin-Out Descriptions
104
Using the USB Port
105
USB Port Output-Case Archive Function
105
USB Port Output-Run Function
108
Using the Digital Output Port
109
Using a Philips Vuelink™* Open Interface (VOI) Module
110
Figure 7-2. Digital Output Connector Pin-Out
110
Select Digital Output Port Data Format
112
Using Hyperterminal™* Via Null Modem Cable to Capture and Store Data
113
Figure 7-3. Null Modem Cable Diagram for Connection to Digital Output Port
114
Table 7-2. Input COM Port Settings Using Hyperterminal
115
Data Output Formats
117
Graph Data Files-Rso2 Versus Time with Microsoft Excel
118
Database Operational Mode and Area under the Curve
119
INVOS™ System Database Application Software
119
Database Variable and Fields
120
Overview
119
Field Name: Cumulative Saturation below Threshold-Left
120
Field Name: Cumulative Saturation below Threshold-Right
120
Field Name: Preinduction Baseline Regional Oxygen Saturation-Left
120
Field Name: Preinduction Baseline Regional Oxygen Saturation-Right
120
Field Name: Cerebral Oximeter Provided the First Indication
121
Field Name: Skin Closure Regional Oxygen Saturation-Left
121
Field Name: Skin Closure Regional Oxygen Saturation-Right
121
Database Operational Mode Screens
121
Figure 8-1. Two-Channel Start Screen in Database Operational Mode
122
Start Screen in Database Operational Mode
122
Figure 8-2. Four-Channel Start Screen in Database Operational Mode
123
Figure 8-3. Main Screen (Four-Channel Monitoring) Database Operational Mode
124
Main Screen in Database Operational Mode
124
Figure 8-4. Tabular Trends for Entering Induction Time Screen
125
Tabular Trends for Entering Induction Time Screen
125
Tabular Trends for Entering Skin Closure Time Screen
125
Database Summary Screen
126
Figure 8-5. Tabular Trends for Entering Skin Closure Time Screen
126
Figure 8-6. Database Summary Screen-Auto Set Baseline
126
Figure 8-7. Database Summary Screen-Real-Time Review before Skin Closure
127
Figure 8-8. Database Summary Screen-Real-Time Review after Skin Closure
127
Features
128
Figure 8-9. Database Summary Screen-Case Archive Review
128
Operating in the Database Operational Mode
129
Baseline Set and Status Database Operational Mode
130
Patient Identifier in Database Operational Mode
131
Collecting Metrics in Database Operational Mode
132
Marking the Induction Time
133
Figure 8-10. Events Marked on Main Screen During Database Operational Mode
134
Marking the Skin Closure Time
134
Capturing the First Alert Metric
135
Marking Metrics at the End of a Case
136
Reviewing the Case in Database Operational Mode
137
Real-Time Review of Database Information
137
Case Archive Function in Database Operational Mode
139
Outputting the Metrics in Database Operational Mode
140
Outputting Database Summary Screen to USB Flash Drive During a Case or Prior to Next Patient
140
Outputting Database Summary to USB Flash Drive in Case Archive Function
141
Cleaning the INVOS™ System
143
Overview
143
Repair Policy
143
Software Upgrades
143
Battery Recharge
144
Check Battery Status
145
Recharge the Battery
145
Annual Inspection Procedure
146
Maintenance Schedule
146
Mechanical Inspection Points
146
Table 9-1. Maintenance Schedule
146
Electrical Inspection Points
147
Table 9-2. Electrical Inspection Points
147
Functional Test with Optional Field Test Device
148
Troubleshooting Techniques
148
Check Fuses
149
Who to Contact for Technical Service
149
Table 9-3. INVOS™ System Troubleshooting Chart
150
Troubleshooting Chart
150
Table 9-4. Digital Output Troubleshooting Chart
151
Troubleshooting Signal Strength Indicator (SSI)
151
Troubleshooting the Digital Output
151
Table 9-5. Signal Strength Indicator Troubleshooting Chart
152
Operational
153
Overview
153
Physical
153
Specifications
153
Electrical
154
Environmental Requirements
154
Alarm Conditions
155
Alarm Tone Definitions
156
Default Settings
156
Additional
157
Guidance and Manufacturer's Declaration-Electromagnetic
159
Guidance and Manufacturer's Declaration-Electromagnetic Emissions
159
Guidance and Manufacturer's Declaration-Electromagnetic Immunity
159
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the INVOS™ System
160
System Diagram
162
B Clinical Studies
165
Overview
165
Hypoxia Study
165
Pediatric Clinical Study
167
Interventional Studies
168
Validation Studies
169
Glossary
172
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Covidien INVOS 5100C Assembly Instructions (2 pages)
Cerebral / Somatic Oximeter GCX Mounting Solutions
Brand:
Covidien
| Category:
Medical Equipment
| Size: 0.81 MB
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