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Part No. 10006048 Rev B (A7213-1) 07/2012
© 2012 Covidien.
Covidien llc
15 Hampshire Street, Mansfield, MA 02048 USA.
Covidien Ireland Limited, IDA Business & Technology Park, Tullamore.
www.covidien.com [T]
1.800.NELLCOR
119
Table of Contents
Main Page
Default Chapter
3
Table of Contents
3
1 Introduction
11
Overview
11
Safety Information
11
Safety Symbols
11
Table 1-1. Safety Symbol Definitions
11
Warnings
12
Cautions
14
Obtaining Technical Assistance
16
Technical Services
16
Related Documents
16
Revision History
17
Warranty Information
17
2 Product Overview
19
Overview
19
Product Description
19
Indications for Use
20
Product Views
21
Front Panel and Display Components
21
Figure 2-1. Front and Side Panel Components
21
Figure 2-2. Display Components
22
Table 2-1. Display Colors
24
Rear Panel
25
Figure 2-3. Rear Panel Components
25
Product and Carton Label Symbols
26
Table 2-2. Symbol Descriptors
26
3 Installation
27
Overview
27
Safety Reminders
27
Unpacking and Inspection
28
Setup
29
Table 3-1. Standard Items
29
Connecting to Power
30
Using the Internal Battery
31
Connecting a Nellcor™ Pulse Oximetry Sensor
32
Figure 3-1. Connecting a Pulse Oximetry Sensor to Interface Cable
33
4 Operation
35
Overview
35
Safety Reminders
35
User Interface
36
Turning on the Monitoring System
36
Turning off the Monitoring System
37
Figure 4-1. Sample Initial Screen
37
Menu Options Navigation
38
Figure 4-2. Save Change Screen
38
Menu Structure
39
Table 4-1. Menu Structure and Available Options
39
Figure 4-3. QUICK ACCESS Spo 2 Menu with Audio Alarm Selected
40
QUICK ACCESS Menus
40
Figure 4-4. QUICK ACCESS PR Menu with Alarm Audio off
41
Figure 4-5. Volume Selection
42
OPTIONS Menu
42
Figure 4-6. Volume Selection
43
Figure 4-7. Response Mode Menu
44
ALARM/LIMITS Menu
45
Figure 4-8. Delete All Trend Data Menu Item
45
Figure 4-9. Alarm/Limits Menu Options
47
PATIENT MODE Menu
47
Figure 4-10. Patient Mode Menu
48
Spo 2 WAVEFORM Menu
48
Spo WAVEFORM Menu
48
Figure 4-11. Highlighting the Waveform Display Area
49
Figure 4-12. Spo 2 Waveform Menu
49
Managing Alarms and Alarm Limits
50
Table 4-2. Alarm Conditions
50
Audible Alarm Indicators
51
Table 4-3. Audio Status
52
Visual Alarm Indicators
53
Factory Defaults
53
Table 4-4. Parameter Ranges and Factory Defaults
53
Maintenance Reminder
54
5 Data Management
55
Overview
55
Tabular Trend Data
55
Figure 5-1. Tabular Trend Data Screen
55
Graphical Trend Data
56
External Data Communication
57
Figure 5-2. Graphical Trend Data Screen
57
Nurse Call Interface
58
Figure 5-3. Nurse Call Interface Pin Layout
59
Trend Data Download
59
Figure 5-4. Trend Data Download Option
61
Figure 5-5. Trend Data Download Status
62
Table 5-1. Operating Status Codes
64
Figure 5-6. Sample Trend Data Printout
65
Figure 5-7. Sample Bridge Driver Installer Window
67
Figure 5-8. Sample New Hardware Wizard Screen
67
Figure 5-9. Sample DEVICE MANAGER Button under Hardware Tab
69
Figure 5-10. Sample Hardware List in Device Manager Window
70
Figure 5-11. Sample Initial USB to UART Bridge Properties Window
71
Figure 5-12. Sample Baud Rate List under Port Settings Tab
72
Firmware Upgrades
72
6 Performance Considerations
73
Overview
73
Oximetry Considerations
73
Pulse Rates
73
Saturation
73
Performance Considerations
74
Overview
74
Patient Conditions
74
Sensor Performance Considerations
75
Reducing EMI (Electromagnetic Interference)
77
Obtaining Technical Assistance
78
7 Preventive Maintenance
79
Overview
79
Cleaning
79
Recycling and Disposal
80
Battery Maintenance
80
Periodic Safety Checks
82
Service
82
8 Troubleshooting
83
Overview
83
General
83
Error Conditions
84
Table 8-1. Common Problems and Resolutions
84
Return
86
9 Accessories
87
Overview
87
Nellcor™ Pulse Oximetry Sensors
87
Table 9-1. Nellcor™ Pulse Oximetry Sensor Models and Patient Sizes
88
Optional Equipment
89
Biocompatibility Testing
90
10 Theory of Operations
91
Overview
91
Theoretical Principles
91
Automatic Calibration
92
Functional Testers and Patient Simulators
92
Unique Technologies
93
Functional Versus Fractional Saturation
93
Measured Versus Calculated Saturation
94
Data Update Period, Data Averaging, and Signal Processing
94
Figure 10-1. Oxyhemoglobin Dissociation Curve
94
Satseconds™ Alarm Management Feature
95
Figure 10-2. Series of Spo
95
Figure 10-3. First Spo 2 Event: no Satseconds Alarm
96
First Spo Event
96
Figure 10-4. Second Spo 2 Event: no Satseconds Alarm
97
Second Spo Event
97
Figure 10-5. Third Spo 2 Event: Triggers Satseconds Alarm
98
Third Spo Event
98
The Satseconds Safety Net
99
11 Product Specifications
101
Overview
101
Physical Characteristics
101
Electrical
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
Sound Pressure
105
Table 11-4. Pulse Oximetry Sensor Accuracy and Ranges
105
Table 11-5. Sound Pressure in Decibels
105
Product Compliance
106
Manufacturer's Declaration
106
Basicselectromagnetic Compatibility (EMC)
106
Table 11-6. Electromagnetic Emissions Guidelines
107
Table 11-7. Electromagnetic Immunity Guidelines
108
Table 11-8. Recommended Separation Distances
109
Sensor and Cable Compliance
110
Safety Tests
110
Table 11-9. Cables and Sensors
110
Table 11-10. Earth and Enclosure Leakage Current Specifications
111
Table 11-11. Patient Applied and Patient Isolation Risk Current
112
Overview
113
Methods
113
Clinical Studies
114
Study Population
114
Study Results
114
Table A-1. Demographic Data
114
Table A-2. Spo 2 Accuracy for Nellcor™ Sensors Vs. CO-Oximeters
114
Adverse Events or Deviations
115
Conclusion
116
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