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Covidien Nellcor Series Manuals
Manuals and User Guides for Covidien Nellcor Series. We have
2
Covidien Nellcor Series manuals available for free PDF download: Operator's Manual, Operator's Manual Addendum
Covidien Nellcor Series Operator's Manual (160 pages)
Bedside SpO2 Patient Monitoring System
Brand:
Covidien
| Category:
Medical Equipment
| Size: 11.02 MB
Table of Contents
Table of Contents
3
1 Introduction
13
Overview
13
Safety Information
13
Safety Symbols
13
Table 1-1. Safety Symbol Definitions
13
Warnings
14
Cautions
16
Technical Assistance
18
Technical Services
18
Related Documents
18
Warranty Information
19
2 Product Overview
21
Overview
21
Product Description
21
Indications for Use
22
Product Views
23
Front Panel and Display Components
23
Figure 2-1. Front and Side Panel Components
23
Figure 2-2. Display Components
24
Rear Panel
27
Table 2-1. Display Colors
27
Figure 2-3. Rear Panel Components
27
Product and Carton Label Symbols
28
Table 2-2. Symbol Descriptors
28
3 Installation
29
Overview
29
Safety Reminders
29
Unpacking and Inspection
30
Table 3-1. Standard Items
30
Power
31
AC Power Connection
31
Internal Battery Power
32
Nellcor™ Pulse Oximetry Sensor Connection
33
Figure 3-1. Connecting a Pulse Oximetry Sensor to Interface Cable
34
4 Operation
37
Overview
37
Safety Reminders
37
Apply Power to Monitoring System
38
Turn on the Monitoring System
38
Turn off the Monitoring System
39
Figure 4-1. Sample Initial Screen
39
Menu Navigation
40
Choose Patient Settings
41
Set Patient Mode (Type)
41
Set Spo 2 and Pulse Rate Alarm Limits
41
Figure 4-2. Save Change Screen
41
Figure 4-3. Spo 2 QUICK ACCESS Menu
43
Figure 4-4. QUICK ACCESS PR Menu
44
Figure 4-5. ALARM/LIMITS Menu Options
44
Set Spo 2 WAVEFORM
45
Figure 4-6. Waveform Display Area Highlighted
45
Manage Alarms and Alarm Limits
46
Table 4-1. Alarm Conditions
46
Audible Alarm Indicators
47
Table 4-2. Audio Status
48
Visual Alarm Indicators
48
Set Additional Patient Modes
49
Mode (Response Mode)
49
Figure 4-8. Response Mode Menu
49
Homecare Mode
50
Figure 4-9. Switch to Homecare Mode
50
Figure 4-10. Password Entry for Homecare Mode
50
Sleep Study Mode
51
Figure 4-11. Delete or Save Trend Data
51
Figure 4-12. Sensor Messages
51
Figure 4-13. Homecare Mode Main Screen with Homecare Icon
51
Figure 4-14. Switch to Sleep Study Mode
52
Figure 4-15. "Disabling of Alarms" Message
52
Figure 4-16. Password Entry for Sleep Study Mode
52
Standard Mode
53
Figure 4-17. Sleep Study Mode Main Screen
53
Select Optional Settings
54
Volume
54
Figure 4-18. Volume Menu Item
54
Figure 4-19. Volume Selection
54
Brightness
55
Figure 4-20. Brightness Menu Item
55
Figure 4-21. Brightness Selection
55
Menu Structure and Factory Defaults
56
Table 4-3. Menu Structure and Factory Defaults
56
Table 4-4. Service Menu Settings (Password Protected)
57
Maintenance Reminder
58
5 Data Management
59
Overview
59
Tabular Trend Data
59
Figure 5-1. Tabular Trend Data Screen
59
Graphical Trend Data
60
Figure 5-2. Graphical Trend Data Screen
60
External Data Communication
61
Nurse Call Interface
61
Figure 5-3. Nurse Call Interface Pin Layout
62
Trend Data Download
63
Table 5-1. Nurse Call Relay Pins States for NORMALLY
63
Table 5-2. Nurse Call Relay Pins States for NORMALLY
63
Figure 5-4. Trend Data Download Option
65
Figure 5-5. Trend Data Download Status
65
Figure 5-6. Sample Trend Data Printout
67
Table 5-3. Status Codes 5
68
Figure 5-7. Sample Bridge Driver Installer Window
69
Figure 5-8. Sample New Hardware Wizard Screen
70
Figure 5-9. Sample Device Manager Button under Hardware Tab
71
Figure 5-10. Sample Hardware List in Device Manager Window
72
Figure 5-11. Sample Initial USB to UART Bridge Properties Window
73
Firmware Upgrades
74
Figure 5-12. Sample Baud Rate List under Port Settings Tab
74
6 Performance Considerations
75
Overview
75
Oximetry Considerations
75
Pulse Rates
75
Saturation
75
Performance Considerations
75
Overview
76
Patient Conditions
76
Sensor Performance Considerations
77
Reducing EMI (Electromagnetic Interference)
79
Obtaining Technical Assistance
80
7 Preventive Maintenance
81
Overview
81
Cleaning
81
Recycling and Disposal
82
Battery Maintenance
82
Periodic Safety Checks
84
Service
84
8 Troubleshooting
85
Overview
85
General
85
Error Conditions
86
Table 8-1. Common Problems and Resolutions
86
Return
88
9 Accessories
89
Overview
89
Nellcor™ Pulse Oximetry Sensors
89
Table 9-1. Nellcor™ Pulse Oximetry Sensor Models and Patient Sizes
90
Optional Equipment
92
Biocompatibility Testing
92
10 Theory of Operations
93
Overview
93
Theoretical Principles
93
Automatic Calibration
94
Functional Versus Fractional Saturation
94
Measured Versus Calculated Saturation
95
Figure 10-1. Oxyhemoglobin Dissociation Curve
95
Satseconds™ Alarm Management Feature
96
Figure 10-2. Series of Spo
96
Figure 10-3. First Spo
97
First Spo Event
97
Figure 10-4. Second Spo Event: no Satseconds™ Alarm
98
Second Spo Event
98
Third Spo Event
99
The Satseconds™ Safety Net
100
11 Product Specifications
101
Overview
101
Physical Characteristics
101
Electrical Requirements
102
Environmental Conditions
102
Table 11-1. Transport, Storage, and Operating Condition Ranges
102
Tone Definition
103
Table 11-2. Tone Definitions
103
Performance Specifications
104
Table 11-3. Trends
104
Table 11-4. Nellcor™ Sensor Accuracy and Ranges
105
Table 11-5. Nellcor™ Sensor Operating Ranges and Power Dissipation
106
Product Compliance
107
Manufacturer's Declaration and Guidance
107
Electromagnetic Compatibility (EMC)
107
Table 11-6. Electromagnetic Emissions Guidelines and Compliance
109
Table 11-7. Electromagnetic Immunity Guidelines and Compliance
110
Table 11-8. Recommended Separation Distance Calculations
111
Table 11-9. Recommended Separation Distances
112
Table 11-10. Test Specifications for Enclosure Port Immunity to RF Wireless Communications Equipment
113
Sensor and Cable Compliance
114
Safety Tests
114
Table 11-11. Cables and Sensors
114
Table 11-12. Earth Leakage and Touch Current
115
Table 11-13. Patient Leakage Current
116
Essential Performance
117
Clinical Studies
119
Overview
119
Methodology
119
Hypoxia Methodology
119
Motion Studies
119
Low Saturation Methodology (Low Saturation Study Only
120
Motion Methodology (Motion Study Only
120
Results
120
Accuracy Results (no Motion
120
Table A-1. Spo2 Accuracy Results (no Motion
121
Table A-2. Pulse Rate Accuracy Results (no Motion
122
Figure A-10. Modified Bland-Altman for Pulse Rate - MAXA Sensor (no Motion): ECG HR Vs. (Pulse Rate - ECG HR
132
Figure A-11. Modified Bland-Altman for Pulse Rate - MAXN Sensor (no Motion): ECG HR Vs. (Pulse Rate - ECG HR
133
Figure A-12. Modified Bland-Altman for Pulse Rate - MAXFAST Sensor (no Motion): ECG HR Vs. (Pulse Rate - ECG HR
134
Figure A-13. Modified Bland-Altman for Pulse Rate - SC-A Sensor (no Motion): ECG HR Vs. (Pulse Rate - ECG HR
135
Figure A-14. Modified Bland-Altman for Pulse Rate - DS-100A Sensor (no Motion): ECG HR Vs. (Pulse Rate - ECG HR
136
Figure A-15. Modified Bland-Altman for Pulse Rate - Oxicliq-A Sensor (no Motion): ECG HR Vs. (Pulse Rate - ECG HR
137
Figure A-16. Modified Bland-Altman for Pulse Rate - D-YSE Sensor (no Motion): ECG HR Vs. (Pulse Rate - ECG HR
138
Figure A-17. Correlation Plot for Spo2 (All Data - no Motion)
139
Figure A-18. Correlation Plot for Pulse Rate (All Data - no Motion): ECG HR Vs. Pulse Rate
140
Accuracy Results (Low Saturation
141
Table A-6. Pulse Rate Accuracy Results (60 to 80% Sao 2
141
Figure A-20. Modified Bland-Altman for Pulse Rate (All Data - Low Saturation): ECG HR Vs. (Pulse Rate - ECG HR
143
Figure A-21. Correlation Plot for Spo2 (All Data - Low Saturation)
144
Table A-7. RMSD of Spo2 Per Decade (Low Saturation
145
Figure A-22. Correlation Plot for Pulse Rate (All Data - Low Saturation): ECG HR Vs. Pulse Rate
145
Accuracy Results (Motion
146
Table A-10. Pulse Rate Accuracy Results During Motion
146
Figure A-24. Modified Bland-Altman for Pulse Rate (All Data - Motion): ECG HR Vs. (Pulse Rate - ECG HR
148
Figure A-27. Modified Bland-Altman for Pulse Rate - MAXA Sensor (Motion): ECG HR Vs. (Pulse Rate - ECG HR
151
Figure A-28. Modified Bland-Altman for Pulse Rate - MAXN Sensor (Motion): ECG HR Vs. (Pulse Rate - ECG HR
152
Figure A-29. Correlation Plot for Spo2 (All Data - Motion)
153
Figure A-30. Correlation Plot for Pulse Rate (All Data - Motion): ECG HR Vs. Pulse Rate
153
Table A-11. Percent Modulation During Motion
154
Conclusion
155
No Motion
155
Motion
155
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Covidien Nellcor Series Operator's Manual Addendum (36 pages)
Bedside Respiratory Patient Monitoring System, Respiration Rate Version 1.0
Brand:
Covidien
| Category:
Medical Equipment
| Size: 2.95 MB
Table of Contents
Table of Contents
3
Table of Contents
5
Overview
5
Introduction
7
Safety Symbol Definitions
7
Related Documents
9
Warranty Information
10
Product Overview
10
Product Description
10
Indications for Use
10
Updated Monitoring Screen
11
Operation
12
Required Pulse Oximetry Sensor Usage
12
Prerequisites
13
Respiration Rate Views
14
Additional Alarm Messages
15
Additional Respiration Rate Parameter
16
Menu Options and Defaults
17
Additional Data Output Fields
19
Real-Time Trend Data
19
Historical Trend Data
21
Performance Considerations
23
Monitoring System Constraints
23
Nellcor™ Sensor Performance Considerations
23
Patient Conditions
26
Troubleshooting
27
Additional Nellcor™ Pulse Oximetry Sensor
28
Theory of Operations
28
Specifications
30
Clinical Studies
31
Methods
31
Study Population
31
Study Results
33
Adverse Events
34
Conclusion
34
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