Capnostream™35
0482
Portable Respiratory
Monitor
PM35MN, with
Microstream™ EtCO2 and
Nellcor™ SPO
Technologies
Operator’s Manual
PN: PT00140239B
2
ii
Capnostream™35 Portable Respiratory Monitor
Copyright Information
©2021-11 Medtronic. All rights reserved. Medtronic, Medtronic
logo and Further, Together are trademarks of Medtronic. TM*
Trademark of its respective owner. All other brands are trademarks
of a Medtronic company.
Covidien, Oridion Medical 1987 Ltd. and Nellcor Puritan Bennett LLC
are Medtronic companies.
Notice: Purchase of this product confers no express or implied
license under any Oridion Medical 1987 Ltd. patent to use the
instrument with any accessory that is not manufactured or licensed
by Oridion Medical 1987 Ltd.
Possession or purchase of this device does not convey an express or
implied license to use the device with unauthorized sensors or
cables which would, alone, or in combination with this device, fall
within the scope of one or more of the patents relating to this
device.
US Patents: www.covidien.com/patents
Exemptions: Oridion Medical 1987 Ltd.'s liability under this warranty
does not include any transportation damage or other charges or
liability for direct, indirect or consequential damages or delay
resulting from improper use or application of the product or the
substitution upon it of parts or accessories not approved by Oridion
Medical 1987 Ltd.
All information in this manual is believed to be correct. Oridion
Medical 1987 Ltd. shall not be liable for errors contained herein with
the performance or use of this manual.
Capnostream™35 Portable Respiratory Monitor
iii
Table of Contents
1. Introduction 14
1.1. Introduction 14
1.2. Safety Information 14
1.2.1. General 14
1.2.2. MRI Scanning 19
1.2.3. Alarms 20
1.2.4. Fire Hazard 22
1.2.5. Electrical 23
1.2.6. Electro-magnetic Interference 25
1.2.7. Connectivity 26
1.3. Definitions 27
1.4. Contacting Technical Support 27
1.5. Symbols 28
1.6. Who Should Read This Manual 31
1.7. Warranty and Disclaimers 31
1.7.1. Warranty 31
1.7.2. Disclaimers 32
2. Product Overview 34
2.1. Overview 34
2.2. Intended Use 35
2.3. Buttons, Indicators and Connections 36
2.3.1. Monitor Front Panel 36
2.3.2. Monitor Back Panel 39
2.3.3. Monitor Right and Left Panels 40
2.3.4. Display Screens 43
2.3.5. Monitoring Display Screen Options 43
2.3.6. Monitor Turn-off 60
2.3.7. Screen Navigation 60
2.3.8. Date, Time, Language, and Other Options 61
2.3.9. Capnostream™35 Monitor Operational Check Sheet 64
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Capnostream™35 Portable Respiratory Monitor
3. Installation 67
3.1. Unpacking and Inspecting the Monitor 67
3.2. Batteries 68
3.2.1. Batteries 68
3.2.2. Removable Battery Pack Installation 69
3.2.3. Battery and Power Usage 71
3.2.4. Battery Hot Swap 72
3.2.5. Battery and AC Connections Indicators 72
3.2.6. Handling the Battery Pack 74
3.2.7. Storing the Battery 74
3.2.8. Disposing of the Battery 75
3.2.9. Internal Battery Pack 75
3.3. Monitor Mounting Plate 75
3.4. Operation in EMS Environments 75
3.5. Periodic Maintenance 77
4. Operation 78
4.1. Turning on the Monitor 78
4.2. Monitor Preparation for a Patient 80
4.2.1. Patient Types 81
4.3. Patient Cases and Patient ID Numbers 83
4.4. Patient Events 83
4.5. Alarm and Pulse Volumes and Alarm Delay 85
4.5.1. Alarm Volume 86
4.5.2. Pulse Tone and Button Click Volume 86
4.5.3. Alarm Volume Default Options 87
4.5.4. Alarm Delay 87
4.6. Use of Scavenging System 88
4.7. Use of Pump Off Mode 89
4.8. Additional Monitor Modes 90
4.8.1. Demo Mode 90
4.8.2. Parameter Standby Mode 91
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4.8.3. EMS Mode 95
4.8.4. Reminder Signal 96
4.9. Monitor Screen Menu Reference Chart 97
4.10. Capnography with the Monitor 98
4.10.1. Microstream™ EtCO2 Consumables 98
4.10.2. FilterLine™ Sampling Line Connection 101
4.10.3. CO2 Data Displayed by the Monitor 102
4.10.4. Adjustable CO2 Parameters 104
4.10.5. Monitoring CO2 during MRI Scanning 106
4.11. Pulse Oximetry with the monitor 108
4.11.1. Pulse Oximetry Features 108
4.11.2. Connecting an SpO2 Sensor to the monitor 109
4.11.3. Nellcor™ Respiration Rate 109
4.11.4. OxiMax™ SPD Alert Management Technology 114
4.11.5. Nellcor™ SpO2 Sensors 121
4.11.6. Nellcor™ SpO2 Sensor Selection 123
4.11.7. Nellcor™ Sensor Features 126
4.11.8. Performance Considerations 126
4.11.9. Nellcor™ Sensor Performance Considerations 128
4.11.10. Nellcor™ Sensor Technology 132
4.11.11. SatSeconds™ alarm management parameter 132
4.11.12. Data Update Period, Data Averaging, and Signal
Processing 137
4.11.13. Nellcor™ Pulse Oximetry with OxiMax™ Technology
Essential Performance 138
4.11.14. SpO2 Data Displayed by the Monitor 140
4.11.15. Adjustable SpO2 Parameters 143
4.11.16. SpO2 Alarm Limit Message 145
4.12. Integrated Pulmonary Index™ Value 146
4.12.1. Integrated Pulmonary Index™ Algorithm: Introduction
146
4.12.2. Integrated Pulmonary Index™ Algorithm Warnings 147
4.12.3. Integrated Pulmonary Index™ Algorithm Display 148
4.12.4. Integrated Pulmonary Index™ Algorithm Options 149
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Capnostream™35 Portable Respiratory Monitor
4.13. Apneas per Hour (A/hr) and the Oxygen Desaturation
Index (ODI) 149
4.13.1. A/hr and ODI: Introduction 149
4.13.2. Apneas per Hour 151
4.13.3. Oxygen Desaturation Index (ODI) 152
4.13.4. Monitoring with A/hr and ODI 152
4.14. Alarms and Messages 154
4.14.1. Alarms Introduction 154
4.14.2. Alarm Display 156
4.14.3. Disabling Alarms 159
4.14.4. Alarm Review Screen 160
4.14.5. Audio Alarm Paused or Off 163
4.14.6. Reminder Signal 165
4.14.7. Message Priorities 165
4.14.8. Alarm Delay 166
4.14.9. Types of Alarms 166
4.14.10. Changing Alarm Limits 177
4.14.11. Testing Alarm Settings 180
4.14.12. Alarm Limits - Factory Defaults 182
4.15. Trends 182
4.15.1. Introduction 182
4.15.2. Trend Storage 182
4.15.3. The Trend Display Screens 183
4.15.4. Choosing Trend Parameters 192
4.15.5. Clearing Trend Memory 192
4.15.6. Trend Display Mode 193
4.15.7. Trends Configuration 193
5. Product Data Output 195
5.1. Report Options 195
5.2. Reports 196
5.3. Data Output 202
5.3.1. Clinical Report Option 211
5.3.2. Printing reports 212
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vii
5.4. Data Transfer 212
5.4.1. USB 215
5.4.2. SD 218
5.4.3. Adapter Cables 218
5.4.4. Ethernet Connectivity 220
5.4.5. Serial Connectivity 221
5.4.6. Connection to Lantronix® Device 223
5.4.7. Working with the Nellcor™ Analytics Tool (NAT) 225
5.4.8. Wireless Communication 228
5.4.9. Vital Sync™ System 238
5.4.10. Printed Reports 242
6. Preventive Maintenance 243
6.1. Introduction 243
6.2. Service Entry and Service Mode Screens 243
6.3. Required Service Activities 245
6.4. Monitor Service Password 245
6.5. CO2 Calibration 249
6.6. CO2 Calibration Check 250
6.6.1. Calibration Check Procedure 251
6.7. Software Support 252
6.8. Operations Log 252
6.9. Maintenance 253
6.10. Cleaning 254
7. Troubleshooting 256
7.1. Electrical Issues 256
7.2. CO2 Troubleshooting 257
7.3. SpO2 Troubleshooting 259
7.4. CO2 Calibration 261
7.5. Returning the Monitor 261
7.6. Technical Assistance 262
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Capnostream™35 Portable Respiratory Monitor
8. Accessories 263
8.1. Microstream™ EtCO2 Consumables 263
8.2. Available Accessories and Spare Parts 270
9. Theory of Operations 273
9.1. Introduction 273
9.2. Features 273
9.3. Technology Overview 274
9.3.1. What is Capnography? 274
9.3.2. What is Pulse Oximetry? 275
10. Product Specifications 279
10.1. Power Supply 279
10.2. Battery 279
10.3. Controls 280
10.4. Display 280
10.5. Sound Pressure Data 281
10.6. Microstream™ Capnography Technology 281
10.7. Nellcor™ Pulse Oximetry 283
10.8. Alarms 285
10.9. General Characteristics 286
10.10. Equipment Classification 287
10.11. Compliance 288
10.12. Electromagnetic Immunity 289
11. Institutional Settings 296
11.1. Institutional Defaults 296
11.1.1. Changing Institutional Defaults 296
11.1.2. Reset to Factory Defaults 297
11.1.3. Institutional Defaults Export/Import 298
11.1.4. Monitor Alarms Settings 299
11.1.5. Monitor Trend Settings 308
11.1.6. Monitor Settings 312
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ix
11.1.7. Home Screen Configuration 318
11.1.8. CO2 Parameters 319
11.1.9. SpO2 Parameters 320
11.1.10. Parameters Settings – Set Colors 321
12. Appendix A: Pulse Oximetry Clinical Studies 323
12.1. Clinical Studies Introduction 323
12.2. Clinical Studies Methodology 323
12.2.1. Hypoxia Methodology (Accuracy, Low Saturation, and
Motion Studies) 323
12.2.2. Low Saturation Methodology (Low Saturation Study
Only) 324
12.3. Clinical Studies Results 325
12.3.1. Accuracy Results (No Motion) 325
12.3.2. Clinical Studies Accuracy Results (Low Saturation) 328
12.3.3. Clinical Studies Accuracy Results (Motion) 331
12.4. Nellcor™ Respiration Rate Clinical Studies 333
12.4.1. Clinical Studies 333
12.4.2. Methods 334
12.4.3. Study Population 334
12.4.4. Study Results 334
12.4.5. Adverse Events 337
12.5. Clinical Studies Conclusion 337
12.5.1. No Motion 337
12.5.2. Motion 337
12.5.3. Nellcor™ Respiration Rate 338
13. Appendix B: Monitor Service Password 339
13.1. Monitor Service Password 339
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Capnostream™35 Portable Respiratory Monitor
List of Figures
Figure 1. Monitor Front Panel 37
Figure 2. Monitor Back Panel 39
Figure 3. Monitor Right View 40
Figure 4. Monitor Left View 42
Figure 5. Home Screen Display #1, Standard 45
Figure 6. Home Screen Display #1, with Nellcor™ RR and OxiMax™
SPD Alert 47
Figure 7. Home Screen Display #2 48
Figure 8. Home Screen Display #3 50
Figure 9. Home Screen Display #4 51
Figure 10. Home Screen Display #5 52
Figure 11. Home Screen Display #6 53
Figure 12. Home Screen Display #7 54
Figure 13. Home Screen Display #8 55
Figure 14. Home Screen Display #9 57
Figure 15. Home Screen Display #10 58
Figure 16. Sample Parameters Adjustment Screen 60
Figure 17. Monitor Bottom, with Battery Pack Installed 69
Figure 18. Trend Memory Message 80
Figure 19. Patient Type Drop-down List 82
Figure 20. Event Marking Screen 84
Figure 21. Monitor Menu Flow 97
Figure 22. CO2 Data on the Monitor 102
Figure 23. CO2 Setup Screen 104
Figure 24. Clinically Significant Desaturation Patterns 115
Figure 25. The SPD Icon 116
Figure 26. Home screen with SPD Alert 120
Figure 27. The SPD Dismiss Window 121
Figure 28. Series of SpO2 Events 133
Figure 29. First SpO2 Event: No SatSeconds™ Alarm 134
Figure 30. Second SpO2 Event: No SatSeconds™ Alarm 135
Figure 31. Third SpO2 Event: Triggers SatSeconds™ Alarm 136
Figure 32. SpO2 Data on Waveform Screen 141
Figure 33. SpO2 Data in Numeric Screen 142
Figure 34. SpO2 Setup Screen 144
Figure 35. IPI Trend Graph 148
Figure 36. ODI and A/hr on the Home Screen 150
Capnostream™35 Portable Respiratory Monitor
xi
Figure 37. High Priority Alarm Example (No Breath) 157
Figure 38. Medium Priority Alarm Example 158
Figure 39. Alarm Enabled Icon (at left) and Alarm Disabled Icon (at
right) 159
Figure 40. Example of Home Screen with Some Alarms Disabled 160
Figure 41. Alarm Review Screen 161
Figure 42. Alarm Setup Screen 178
Figure 43. Graphical Trend Screen - 1 Hour Display 185
Figure 44. Tabular Trend Screen – 30 Second Display 188
Figure 45. Events List 191
Figure 46. Report Selection 196
Figure 47. Vent and Desat Report A 197
Figure 48. Vent and Desat Report B 199
Figure 49. Parameter Statistics Report 200
Figure 50. Alarm Review Report 201
Figure 51. Sample Html Report: Tabular Trend 211
Figure 52. Typical Flash Memory Device 215
Figure 53. Adapter Cable LEDs 218
Figure 54. WiFi Connection Icon; WiFi off at left, on at right 229
Figure 55. Menu Connectivity Screen showing WiFi connected 230
Figure 56. Service Mode Connectivity Screen, with Connected
Network 231
Figure 57. WiFi Configuration 236
Figure 58. Service Entry Screen, bottom section 244
Figure 59. Service Mode Screen 244
Figure 60. Service Entry Screen 246
Figure 61. Service Mode Password Change 246
Figure 62. Service Mode Password Change, Entering a New
Password 247
Figure 63. Password Successfully Set Pop-up Window 248
Figure 64. Variations of the Pleth due to Respiration 277
Figure 65. Revert To Factory Defaults Screen 298
Figure 66. Institutional Defaults Alarm Setup 302
Figure 67. Modified Bland-Altman for SpO2 (All Data - No Motion):
SaO
vs. (SpO2 - SaO2) 327
2
Figure 68. Modified Bland-Altman for SpO2 (All Data - Low
Saturation): SaO
vs. (SpO2 - SaO2) 329
2
Figure 69. Modified Bland-Altman for SpO2 (All Data - Motion): SaO2
vs. (SpO
- SaO2) 332
2
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Capnostream™35 Portable Respiratory Monitor
Figure 70. Modified Bland-Altman Plot of Nellcor Respiration Rate
Software versus Clinician Overscored Respiration Rate 336
List of Tables
Table 1. Symbols that Appear on the Monitor and its Packaging 28
Table 2. Display Options Available on System Screen 62
Table 3. Event Markings 85
Table 4. Message and Alarm Status during Different Parameter
Standby Situations 93
Table 5. CO2 Parameters 105
Table 6. CO2 Waveform Setup Parameters 106
Table 7. Nellcor™ SpO2 Sensor Models and Patient Sizes 124
Table 8. Pulse Oximetry Performance 138
Table 9. Electromagnetic Immunity Compliance and Guidance, Not
Life-Supporting Equipment 139
Table 10. Adjustable SpO2 Parameters 145
Table 11. IPI Values 147
Table 12. Adjustable IPI Options 149
Table 13. Alarm Indications 155
Table 14. High/Medium Priority Alarms 166
Table 15. Advisory Messages 173
Table 16. Silent Advisory Messages 173
Table 17. Waveform Area Messages 176
Table 18. Trend Increments and Zoom Levels 187
Table 19. Report Options Access 195
Table 20. Ventilation and Desaturation and Parameter Statistics
Report Types 202
Table 21. Data Transfer Report Types 204
Table 22. Connectivity Icons 213
Table 23. Communication Protocols 214
Table 24. USB File Naming Convention 216
Table 25. USB Files Examples 217
Table 26. Serial Adapter Cable (RS232 and RS422) LEDs 219
Table 27. Ethernet (LAN) Adapter Cable LEDs 219
Table 28. NAT Alarms 227
Table 29. Wireless Specifications 237
Table 30. Microstream™ Consumables 263
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Table 31. Microstream™ Advance Consumables 265
Table 32. Monitor Accessories and Spare Parts 270
Table 33. Nellcor™ Adult Respiratory Sensor Operating Range and
Power Dissipation Power Dissipation 52.5 mW 285
Table 34. Guidance and Manufacturer’s Declaration -
Electromagnetic Emissions 289
Table 35. Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity 290
Table 36. Recommended Separation Distances between Portable
and Mobile RF Communications Equipment and the
Monitor 294
Table 37. Factory Default Alarm Limits 299
Table 38. Parameters Available on the Alarm Review Screen 306
Table 39. Alarm Delay Settings 307
Table 40. Parameters Available on the Trend Screens 311
Table 41. Percent Modulation During Motion 325
Table 42. SpO2 Accuracy Results (No Motion) 326
Table 43. RMSD of SpO2 per Decade (No Motion) 328
Table 44. RMSD of SpO2 per Plateau (No Motion) 328
Table 45. SpO2 Accuracy Results (60 to 80% SaO2, low saturation) 328
Table 46. RMSD of SpO2 per Decade (Low Saturation) 330
Table 47. RMSD of SpO2 per Plateau (Low Saturation) 330
Table 48. SpO2 Accuracy Results during Motion 331
Table 49. RMSD of SpO2 per Decade (Motion) 333
Table 50. RMSD of SpO2 per Plateau (Motion) 333
Table 51. Demographic Data 334
Table 52. Accuracy and Precision for Respiration Rate, Version 2.0 vs.
Capnography-Based Reference 335
Table 53. Local Bias with Respect to Reference Respiratory Rate 337
Capnostream™35 Portable Respiratory Monitor
14
1. Introduction
1.1. Introduction
Carefully read this operator’s manual and the Directions for Use that
accompany Microstream™ etCO
henceforth referred to as sampling lines) and the SpO2 sensors, in order to
use the Capnostream™35 portable respiratory monitor PM35MN, with
Microstream™ EtCO
to as the Capnostream™35 monitor or the monitor) correctly and safely. Use
of the monitor requires full understanding and strict observance of these
instructions, the precautionary information, and the specifications.
and Nellcor™ SPO2 technologies (henceforth referred
2
1.2. Safety Information
1.2.1. General
sampling lines (FilterLine™ sampling lines,
2
WARNING:
If uncertain about the accuracy of any measurement, first
check the patient’s vital signs by alternate means, and then
make sure the monitor is functioning correctly.
WARNING:
Patient monitoring via a network connected to the monitor
is intended to supplement and not replace any part of the
hospital's device monitoring. Do not rely on the remote
patient monitoring as the sole source of patient data.
In order to assure a timely response to changes in patient
status, a clinician must be within visual and/or audible range
of the monitoring device. In order to provide medical
Safety Information
Capnostream™35 Portable Respiratory Monitor
15
intervention, a clinician must interact with the device at the
bedside.
WARNING:
The monitor should not be used as an apnea monitor.
WARNING:
The monitor should be considered an early warning device.
As a trend towards patient deoxygenation is indicated,
blood samples should be analyzed by a laboratory cooximeter to completely understand the patient's condition.
WARNING:
To ensure patient safety, do not place the monitor in any
position that might cause it to fall on the patient. If the
monitor is mounted, ensure that is securely mounted.
WARNING:
Carefully route patient cabling (SpO
line) to reduce the possibility of patient entanglement or
strangulation.
sensor and sampling
2
WARNING:
Do not lift the monitor by the SpO
line, as they could disconnect from the monitor, causing the
monitor to fall on the patient.
WARNING:
Do not obstruct the monitor so that the visual alarm
indicators cannot be seen or the audio alarm indicators
cannot be heard.
WARNING:
The monitor should not be used adjacent to or stacked with
other equipment; if adjacent or stacked use is necessary, the
sensor cable or sampling
2
Safety Information
16
Capnostream™35 Portable Respiratory Monitor
monitor shall be observed to verify normal operation in the
configuration in which it will be used.
WARNING:
Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
WARNING:
All cables and tubing, including SpO2 sensors and CO2
sampling lines, should be kept clear of the defibrillator and
its electrodes, and should not run between, adjacent to, or
overlapping the electrodes and the electrode wires, in order
to reduce potential interference between the monitor and
defibrillation equipment.
WARNING:
All SpO
in order to enable use of a defibrillator with the monitor.
sensors must be completely intact and undamaged,
2
WARNING:
Re-use of single-use accessories could pose a crosscontamination risk to the patient or damage the functioning
of the monitor.
WARNING:
readings, respiratory rate, pulse oximetry readings, and
CO
2
pulse signals can be affected by sensor application errors,
certain ambient environmental conditions, including
electromagnetic interference, and certain patient
conditions.
WARNING:
The monitor is a prescription device and is to be operated by
qualified healthcare personnel only.
Safety Information
Capnostream™35 Portable Respiratory Monitor
17
WARNING:
No modification of this equipment is allowed.
WARNING:
If calibration does not take place as instructed in the
relevant service manual, the monitor may be out of
calibration. A monitor that is out of calibration may provide
inaccurate results.
WARNING:
Do not use any monitoring system, sensor, cable, connector,
or screen that appears damaged. Remove any damaged
equipment from service for inspection by a qualified service
technician.
WARNING:
Do not perform service or maintenance on the device while
it is in use.
WARNING:
The device is not sterile. Do not autoclave or sterilize this
device.
WARNING:
Do not transport damaged or defective lithium cells and
batteries via air transport.
WARNING:
Charge the monitor fully before your first use of the
monitor, by attaching the monitor to AC power with the
removable battery installed. See 3.2.5 Battery and AC
Connections Indicators on page 72 for more information.
Safety Information
18
Capnostream™35 Portable Respiratory Monitor
WARNING:
The unit should always be operated with the removable
battery installed in order to provide back-up power in the
event of a momentary or temporary power outage.
WARNING:
The characteristics of a breath are calculated differently for
the different patient types. Setting the correct patient type
is therefore very important. Incorrect setting will result in
inaccurate monitoring of the patient's respiration, and could
lead to incorrect alarm limits or produce incorrect patient IPI
data.
WARNING:
Changing the institutional default settings might adversely
affect the monitoring of patients. Changes to the
Institutional settings must only be made by authorized
personnel.
Caution:
Storage or transport of the monitor under environmental
conditions beyond those mentioned in the specification will
affect monitor performance and damage the monitor.
Note:
Temperature sensors will turn the monitor off when it
exceeds the permitted temperature.
Note:
Dispose of calibration gases according to local regulations
for disposal of gases.
Note:
Any serious incident related to device use that may occur
Safety Information
Capnostream™35 Portable Respiratory Monitor
19
should be reported immediately to the manufacturer, the
local competent authority, and any other regulators as
required.
Devices connected to the monitor must be medical grade only.
The accurate display of the following parameters is required in order to fill
the essential performance of the monitor: Carbon dioxide levels in expired
breath (CO
saturation of blood (SpO2) and pulse rate when monitoring with pulse
oximetry. If the patient is being monitored with both functions, all of these
parameters will be displayed. If the patient is being monitored with either
or both functions, alarm volume is included in the monitor's essential
performance.
) when monitoring with capnography, and arterial oxygen
2
1.2.2. MRI Scanning
WARNING:
Do not use oximetry sensors during magnetic resonance
imaging (MRI) scanning. Conducted current could cause
burns. The sensors may affect the MRI image, and the MRI
unit may affect the accuracy of oximetry measurements.
WARNING:
Do not use the FilterLine™ H Set Infant/Neonatal set, the
VitaLine™ H Set Infant/Neonatal set, or any of the
Microstream™ Advance Neonatal-Infant Intubated CO
Line Extended Duration products during magnetic
resonance imaging (MRI) scanning. Using these products
during MRI scanning could harm the patient.
WARNING:
During MRI scanning, the monitor must be placed outside
the MRI suite. When the monitor is used outside the MRI
suite, etCO
FilterLine™ XL or the MRI XL sampling line. Reference 4.10.5
Monitoring CO2 during MRI Scanning on page 106.
monitoring can be implemented using the
2
Filter
2
Safety Information
20
Capnostream™35 Portable Respiratory Monitor
Caution:
Use of a CO2 sampling line with H in its name (indicating that it
is for use in humidified environments) during MRI scanning
may cause artefacts on the MRI image. The use of non-H
sampling lines is advised. For a list of sampling lines, reference
8.1 Microstream™ EtCO2 Consumables on page 263.
1.2.3. Alarms
WARNING:
Do not silence, pause or decrease the volume of the audible
alarm if patient safety may be compromised.
WARNING:
Do not pause or turn off the audible alarms until you verify
that the patient is being monitored by other means, such as
direct observation.
WARNING:
Do not decrease the volume of the audible alarm to a level
that is less than the ambient sound level. Doing so might
impede operator recognition of the audible alarm, which
might lead to patient harm during an alarm situation.
WARNING:
Always respond immediately to a device alarm since the
patient may not be monitored during certain
technical/caution alarm conditions.
WARNING:
Before each use, verify that the alarm enabled/disabled
status and the alarm limits are appropriate for the patient
being monitored.
Safety Information
Capnostream™35 Portable Respiratory Monitor
21
WARNING:
Do not set alarm limits to extreme values that render the
monitoring system ineffective. Ensure alarm limits are
appropriate for each patient.
WARNING:
Do not preset different or inappropriate alarm limits for the
same or similar equipment in any single area, since this may
compromise patient safety.
WARNING:
Remote alarm generation is intended to supplement and
not replace any part of the hospital's device monitoring. Do
not rely on the remote alarms as the sole source of alarms.
In order to assure a timely response to device alarms, a
clinician must be within visual and/or audible range of the
alarming device. In order to provide medical intervention, a
clinician must interact with the device at the bedside.
WARNING:
Consider the following when setting delays on alarms that
are being viewed with a remote alarm system: Connected
devices report data to the application periodically, not
continuously. Because of this, as well as delays caused by
network bandwidth or hardware limitations or network
loading, the true duration of any device alarm will be longer
than the delay set in this screen for that alarm. Carefully
consider these factors when choosing delay settings, and
use the shortest delay settings that are practical to reduce
nuisance alarms, to avoid undue delay in response to events
actually requiring direct clinical intervention.
Safety Information
22
Capnostream™35 Portable Respiratory Monitor
1.2.4. Fire Hazard
WARNING:
When using the monitor with anesthetics, nitrous oxide or
high concentrations of oxygen, connect the gas outlet to a
scavenger system.
WARNING:
The monitor is not suitable for use in the presence of
flammable anesthetic mixture with air, oxygen or nitrous
oxide.
WARNING:
The sampling line may ignite in the presence of O
directly exposed to laser, ESU devices, or high heat. When
performing head and neck procedures involving laser,
electrosurgical devices or high heat, use these devices with
caution to prevent flammability of the sampling line or
surrounding surgical drapes.
when
2
Caution:
Recharge the removable battery pack only in the monitor or
the external battery charger (reference 8.2 Available Accessories
on page 270) to avoid possible heating, burning or rupture of
the battery pack.
Caution:
The battery used in this device may present a risk of fire or
chemical burn if mistreated. Do not disassemble, operate the
monitor beyond its environmental specifications (reference
10.9 General Characteristics on page 286), or incinerate. Replace
battery with Medtronic PN PM35BTY only. Use of another
battery or a refurbished battery may present a risk of fire or
explosion.
Safety Information
Capnostream™35 Portable Respiratory Monitor
23
Caution:
Replace the battery according to the instructions in this
manual. Dispose of used battery promptly. Keep away from
children. Do not open or short circuit the battery. Misuse may
cause battery to ignite, explode, leak or get hot, causing
personal injury.
1.2.5. Electrical
WARNING:
To protect against electric shock hazard, the monitor’s cover
is to be removed only by qualified service personnel. There
are no user-serviceable parts inside.
WARNING:
To ensure patient electrical isolation, connect only to other
equipment with circuits that are electrically isolated.
WARNING:
Do not connect the monitor to a power supply other than
that supplied with the monitor.
WARNING:
To avoid the risk of electric shock, the monitor must be
connected only to a supply mains with protective earth.
WARNING:
Connect the monitor only to a hospital grade receptacle. The
plug must be inserted into a properly wired receptacle; if a
properly wired receptacle is not available, a qualified
electrician must install one in accordance with the
governing electrical code. Do not use extension cords or
adapters of any type. The power cord and plug must be
intact and undamaged.
Safety Information
24
Capnostream™35 Portable Respiratory Monitor
WARNING:
Do not connect to an electrical outlet controlled by a wall
switch or a dimmer.
WARNING:
Measure the monitor’s leakage current whenever an
external device is connected to the serial port. Leakage
current must not exceed 100 microamperes.
WARNING:
Protection of the monitor against the effects of the
discharge of a cardiac defibrillator is dependent upon the
use of appropriate SpO
Nellcor™ SpO2 Sensor Models and Patient Sizes on page 124.
cables and sensors listed in Table 7.
2
Caution:
Any USB device (excluding a flash memory drive) or PC
connected to the monitor must be running on a battery, or a
IEC 60601-1 compliant power supply (Clause 16, ME Systems),
or a IEC 60601-1 compliant isolation transformer (Clause 16,
ME Systems).
Caution:
All signal input and output (I/O) connectors are intended for
connection of devices complying with Clause 16, ME Systems,
of IEC 60601-1 only. Connecting additional devices to the
monitor may increase chassis or patient leakage currents. To
maintain operator and patient safety, consider the
requirements of Clause 16, ME Systems, of IEC 60601-1.
Measure the leakage currents to confirm that no electric shock
hazard exists.
Caution:
Electrical installation of the room or the building in which the
monitor is to be used must comply with regulations specified
by the country in which the equipment is to be used.
Safety Information
Capnostream™35 Portable Respiratory Monitor
25
Caution:
Keep power cord, plug and socket clear in case an urgent
power supply disconnection is required.
1.2.6. Electro-magnetic Interference
This monitor has been tested and found to comply with the requirements
for medical devices according to the standard IEC 60601-1-2. This standard
is designed to provide reasonable protection against harmful interference
in a typical medical installation.
However, because of the proliferation of radio-frequency transmitting
equipment and other sources of electrical noise in healthcare
environments (for example: cellular phones, mobile two–way radios,
electrical appliances), it is possible that high levels of such interference due
to close proximity or strength of a source may result in disruption of
performance of this device.
WARNING:
Operating high frequency electrosurgical equipment in the
vicinity of the monitor can produce interference in the
monitor and cause incorrect measurements. Do not use the
monitor with nuclear spin tomography (MRT, NMR, NMT) as
the function of the monitor may be disturbed.
WARNING:
EMI disruption can cause erratic readings, cessation of
operation, or other incorrect functioning.
WARNING:
The monitoring system is intended for use by healthcare
professionals only. It may cause radio interference or may
disrupt the operation of nearby equipment. Mitigation for
such disruption may require re-orienting or relocating the
monitoring system or shielding the location.
Safety Information
26
Capnostream™35 Portable Respiratory Monitor
WARNING:
Portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part
of this monitor, including cables specified by the
manufacturer. Otherwise, degradation of the performance
of this equipment could result.
1.2.7. Connectivity
WARNING:
Ensure the security of a WiFi network before connecting the
device to the network; connection to an unsecure network
may endanger patient data. Access of unauthorized
personnel through an unsecure network may result in
patient risk.
WARNING:
Use the appropriate configuration information to ensure
proper connectivity.
WARNING:
If there are changes to the network with which you are
connecting the device, verify that changes are reflected in
the device to ensure connectivity.
WARNING:
The Capnostream™35 monitor has been approved for use
with the Vital Sync™ system. Use with hospital data systems
other than the Vital Sync™ system is under the user’s
responsibility.
WARNING:
Only use Medtronic-approved hardware or remote
monitoring software for data port connectivity.
Contacting Technical Support
Capnostream™35 Portable Respiratory Monitor
27
1.3. Definitions
Note:
A Note is inserted to point out procedures or conditions
which may otherwise be misinterpreted or overlooked and
to clarify apparently contradictory or confusing situations.
Caution:
A Caution is inserted to call attention to a procedure which, if
not followed exactly, can lead to damage or destruction of the
equipment.
WARNING:
A Warning is inserted to call attention to dangerous or
hazardous conditions inherent to the operation, cleaning,
and maintenance of the equipment which may result in
personal injury or death of the operator or patient.
1.4. Contacting Technical Support
For any technical issue involving the monitor, contact your local Service
Center or Covidien Technical Support, as follows:
North America: Tel: 1-888-ORIDION (674-3466), Fax: (781) 453-2722; Outside
North America: Tel: + (972) 2-589-9104, Fax: + (972) 2-582-8868; E-mail:
Capnographytechnicalsupport@medtronic.com
Symbols
28
Capnostream™35 Portable Respiratory Monitor
1.5. Symbols
The following symbols appear on the body of the monitor.
Table 1. Symbols that Appear on the Monitor and its Packaging
Symbol Description
Monitor ON/OFF button
Battery/power indicator
Home button
Back button
Temporarily silence audible alarms
Enter button with directional arrows
Type BF Defibrillator Proof Protection
Gas inlet
Gas outlet
port indicator
CO
2
Symbols
Capnostream™35 Portable Respiratory Monitor
29
Micro SD card port
12VDC
Nellcor™ SpO2 connection
USB flash memory connection port
Monitor connection
Federal Communications Commission
For prescription use only
Caution, consult accompanying
documents
Follow Instructions for Use (symbol
appears in blue on monitor)
Directive on waste from electrical and
electronic equipment
Non-ionizing electromagnetic radiation
Wireless regulation (Australia)
Symbols
30
Capnostream™35 Portable Respiratory Monitor
IPX rating
TUV Mark
CE Mark
Serial number
Catalog number
Date of manufacture
Manufacturer
EC Representative
Shipping symbols
Temperature limit for storage and
transport
Humidity limit for storage and transport
Atmospheric pressure limit for storage and
transport