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
Warranty and Disclaimers
Capnostream™35 Portable Respiratory Monitor
31
1.6. Who Should Read This Manual
The following persons should read this manual:
• Health Care Professionals who will be using the monitor.
• Equipment managers responsible for ensuring that equipment
conforms to institutional policies.
• Researchers or laboratory personnel who will be downloading
patient data.
• Technical experts who will be connecting the monitor to a
computer.
WARNING:
In the United States, federal law restricts this device to sale
by or on the order of a physician.
1.7. Warranty and Disclaimers
1.7.1. Warranty
Oridion Medical 1987 Ltd. ("Oridion Medical") - Warranty for Oridion
Monitors:
THIS LIMITED WARRANTY applies to any patient monitor manufactured by
Oridion Medical 1987 Ltd. (“Oridion”), (“Products”). Subject to the limitations
herein, Oridion warrants that Products, when delivered by Oridion or its
authorized distributor, for two (2) years following the delivery date, but no
more than 27 months following the date of production, will be free from
defects in material and workmanship and will substantially conform to
published Oridion specifications for the respective Products and in effect at
the time of manufacture. This limited warranty excludes (i) Products
purchased through unauthorized third parties; (ii) Products that have been
Warranty and Disclaimers
32
Capnostream™35 Portable Respiratory Monitor
subject to misuse, mishandling, accident, alteration, neglect, opening of
any sealed components without Oridion's written approval, fire, lightening,
or other peril, , unauthorized repair or installation, or from any other cause
beyond Oridion's reasonable control, including force majeure; (iii) Products
that have had the serial number, model number or any other identification
markings removed, modified or rendered illegible; and (iv) Products that
have been used with accessory consumable products other than
Oridion’s FilterLine™ products. Furthermore, this limited warranty shall not
apply to the use of Products in an application or environment that is not
within Oridion specifications or in the event of any act, error, neglect or
default of Customer. Oridion at its sole discretion will replace or repair the
damaged Products. Customer may not return Products without first
obtaining a customer return material authorization (RMA) number from
Oridion or one of the Authorized Service centers and a copy of the Product
purchase invoice. Customer shall be solely responsible for the selection,
use, efficacy, efficiency and suitability of the Products.
1.7.2. Disclaimers
CUSTOMER MAY USE THE PARAMETERS (INCLUDING ANY AND ALL
REFERENCES TO CO
ALGORITHM AND FUTURE AND RELATED INDICES AND CONFIGURATIONS
AND SIGNAL ALARM NOTIFICATIONS) WHICH APPEAR ON ORIDION'S
PATIENT MONITORING DEVICES AND/OR ORIDION’S COMMUNICATION
PROTOCOL AND/OR ANY OUTPUT IN REPORTS DOWNLOADED FROM
ORIDION'S PATIENT MONITORING DEVICES TO PRINTERS OR USB MEMORY
STICKS OR APPROVED SYSTEMS ("DATA") SOLELY AND EXCLUSIVELY FOR
THE PURPOSE OF PATIENT CARE. CUSTOMER ACKNOWLEDGES THAT DATA
TRANSMITTED FROM ORIDION'S PATIENT MONITORING DEVICES MAY NOT
BE TRANSFERRED, INTERFACED, EXCHANGED OR OTHERWISE TRANSMITTED
AND THAT ORIDION ACCEPTS NO RESPONSIBILITY WHATSOEVER FOR THE
ACCURACY OR COMPLETENESS OF DATA THAT HAS BEEN TRANSFERRED,
INTERFACED, EXCHANGED OR OTHERWISE TRANSMITTED. CUSTOMER
FURTHER ACKNOWLEDGES THAT IT MAY NOT SELL, LICENSE OR OTHERWISE
COMMERCIALIZE THE DATA, IN WHOLE OR IN PART. ANY OTHER USE OF
THE DATA OR INTERFACE WITH OTHER SYSTEMS, WHETHER BY CUSTOMER
OR ANY PARTY ON ITS BEHALF, SHALL BE SUBJECT TO A SEPARATE
LICENSING ARRANGEMENT WITH ORIDION, INCORPORATING, BUT NOT
LIMITED TO, COMMERCIAL TERMS TO BE NEGOTIATED IN GOOD FAITH.
, SpO2 , CURRENT INTEGRATED PULMONARY INDEX™
2
Warranty and Disclaimers
Capnostream™35 Portable Respiratory Monitor
33
CUSTOMER ACKNOWLEDGES AND UNDERSTANDS THAT THE DATA IS
PROVIDED “AS-IS” AND THAT ORIDION DISCLAIMS ALL WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
THE WARRANTIES PROVIDED IN THIS DOCUMENT CONSTITUTE
CUSTOMER'S SOLE AND EXCLUSIVE LIABILITY FOR DEFECTIVE OR
NONCONFORMING PRODUCTS AND SHALL CONSTITUTE CUSTOMER'S
SOLE AND EXCLUSIVE REMEDY FOR DEFECTIVE OR NONCONFORMING
PRODUCTS. THESE WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES
EXPRESS, IMPLIED OR STATUTORY, INCLUDING, BUT NOT LIMITED TO,
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, AND ARE IN LIEU OF ALL OBLIGATIONS OR
LIABILITIES ON THE PART OF ORIDION FOR DAMAGES. IN NO EVENT SHALL
ORIDION BE LIABLE FOR CUSTOMER’S COSTS OF PROCURING SUBSTITUTE
PRODUCTS.
ORIDION WILL NOT BE LIABLE FOR ANY INJURIES OR DAMAGES TO ANY
PERSONS OR TANGIBLE OR INTANGIBLE PROPERTY RESULTING FROM ANY
CAUSE WHATSOEVER. ORIDION DISCLAIMS ANY AND ALL LIABILITY FOR
DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PUNITIVE OR
OTHER SIMILAR DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOSS OF
PROFIT, LOSS OF USE, LOSS OF REVENUES OR DAMAGES TO BUSINESS OR
REPUTATION, REGARDLESS OF THE FORM OF ACTION WHETHER IN
CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT PRODUCT LIABILITY
OR ANY OTHER LEGAL OR EQUITABLE THEORY, EVEN IF ORIDION HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH LOSSES OR DAMAGES.
2. Product Overview
The Capnostream™35 monitor operational check sheet is provided at the
end of this chapter to simplify the installation, setup, and getting started
processes. Photocopy the Check Sheet from the manual and check off the
steps on the Check Sheet as you set up the monitor.
2.1. Overview
This manual provides directions for setting up and operating the monitor.
The Capnostream™35 portable respiratory monitor PM35MN, with
Microstream™ EtCO
monitor that continuously monitors a patient’s:
• End tidal carbon dioxide (etCO2) - level of carbon dioxide in
exhaled breath
• Respiratory rate (RR), derived from capnography or pulse
oximetry
and Nellcor™ SPO2 technologies, is a portable bedside
2
• Oxygen saturation (SpO2)
• Pulse rate (PR)
The monitor also provides an Integrated Pulmonary Index™ algorithm
(henceforth referred to as IPI) value, which is a numerical value that
integrates four major parameters measured by the monitor in order to
provide a simple indication of the patient’s ventilatory status. The
integrated parameters are etCO
parameters are used to calculate IPI; other parameters are not taken into
account.
In addition, the monitor provides Apneas per Hour (A/hr) (also known as
ASA, Apnea Saturation Alert) and an Oxygen Desaturation Index (ODI), used
RR, SpO2, and PR. Only these four
2,
Intended Use
Capnostream™35 Portable Respiratory Monitor
35
to help in the identification and quantification of apnea and oxygen
desaturation events for patients over age 22, as follows:
A/hr: a count of the number of pauses in breathing (of at least 10 seconds)
which the patient experienced, either over the past hour (on the Home
screen) or average pauses per hour over a period of time (on the Apnea
Desaturation screen).
and O
2
ODI: the number of times that the SpO
value dropped 4% or more from
2
baseline and returned to baseline in 240 seconds or less, either in the last
hour (on the home screen) or average drops per hour over a period of time
(on the Apnea and O
Desaturation screen).
2
The device also provides the OxiMax™ SPD (Saturation Pattern Detection,
henceforth referred to as SPD) and Nellcor™ respiration rate features,
described in 4.11.4 OxiMax™ SPD Alert Management Technology on page 114.
The Nellcor™ respiration rate and OxiMax™ SPD features are not available
on all devices or in all countries. Availability of these features will depend,
inter alia, on the registration of the monitor in your location. For more
information, contact Capnographytechnicalsupport@medtronic.com.
This manual covers the Capnostream™35 monitor for Software Revision
1.07.0 and up and hardware revision F.XX.
2.2. Intended Use
Intended Purpose: The capnography monitor systems provide
measurements of carbon dioxide during the respiration cycle.
Intended Use: The Capnostream™35 monitor is a portable
capnograph/pulse oximeter, intended to provide professionally trained
health care providers with continuous non-invasive monitoring of carbon
dioxide concentration of the expired and inspired breath, respiration rate,
arterial oxygen saturation (SpO
neonatal patients. The pulse oximeter is intended for use during both no
motion and motion conditions and for patients who are well or poorly
perfused.
) and pulse rate of adult, pediatric, and
2
Buttons, Indicators and Connections
36
Capnostream™35 Portable Respiratory Monitor
The Capnostream™35 monitor also provides the clinician with integrated
pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index
(ODI) values. IPI is intended for pediatric and adult patients only. A/hr and
ODI are intended for age 22 and up. The OxiMax SPD™ alert (SPD) feature is
intended only for facility-use care of adults to detect patterns of
desaturation indicative of repetitive reductions in airflow through the
upper airway and into the lungs.
The Nellcor™ respiration rate parameter is intended for the continuous,
non-invasive monitoring of respiration rate in adult patients in hospitals
and hospital-type facilities.
Other than the OxiMax SPD™ alert and Nellcor™ respiration rate features,
the device is intended for use in hospitals, hospital-type facilities, during
intra-hospital transport, and out-of-hospital Emergency Medical Service
applications that include ground and air transport.
2.3. Buttons, Indicators and Connections
Following are the front, rear, and side views of the monitor showing the
display, controls, and external connection points.
2.3.1. Monitor Front Panel
The monitor’s front panel controls are described below. Reference Figure 1.
Monitor Front Panel, below.
Buttons, Indicators and Connections
Capnostream™35 Portable Respiratory Monitor
37
priority
Figure 1. Monitor Front Panel
1 2 5 3 4
6 7 8 9
Label Name Description Label Name Description
1
2
3
On/Off
button
Battery/
power
indicator
Medium
Priority
Alarm
Turns the
monitor on
or off
Indicates
batteries
and power
status
Indicates
current
medium
6
7
8
10
Back
button
Home
button
Menu
button
Returns the
user to the
previous
screen
Returns the
user to the
Home screen
Opens the
Menu screen
so a menu
Buttons, Indicators and Connections
38
Capnostream™35 Portable Respiratory Monitor
LED
alarm
option can
indicator
4
High
Priority
Alarm
LED
indicator
status
Indicates
current
high
priority
alarm
status
5
Ambient
light
sensor
Senses
level of
ambient
light and
adjusts
screen
brightness
9
10
Audio
Alarm
Paused
button
Enter
button
and
directio
nal
arrows
be chosen
Silences the
audible
alarms for
two minutes
Used for
navigation
and menu
selection
Buttons, Indicators and Connections
Capnostream™35 Portable Respiratory Monitor
39
2.3.2. Monitor Back Panel
Figure 2. Monitor Back Panel
Label Function Description
1 Connector Connects the monitor with
1
2
optional accessories
2 Product label N/A
Buttons, Indicators and Connections
40
Capnostream™35 Portable Respiratory Monitor
2.3.3. Monitor Right and Left Panels
Figure 3. Monitor Right View
2 1
3
4
Buttons, Indicators and Connections
Capnostream™35 Portable Respiratory Monitor
41
Label Function Description
1 Gas outlet To connect to a scavenger system
when the monitor is used in the
presence of anesthetic gases. The
gas output is a barbed style
connector intended for 3/32-inch ID
tubing.
2 CO2 input
connector port
Port for connecting Microstream™
sampling line
CO
2
3 Micro SD port Port for micro SD card
4
12VDC connector
To connect to AC adapter
port
Buttons, Indicators and Connections
42
Capnostream™35 Portable Respiratory Monitor
Figure 4. Monitor Left View
1
2
3
Buttons, Indicators and Connections
Capnostream™35 Portable Respiratory Monitor
43
Label Function Description
1
Nellcor™ SpO
port
sensor
2
Port for connecting Nellcor™
sensor
SpO
2
Port for connecting USB flash
drive, customized Medtronic
2 USB connector port
USB adapter cables, or
Lantronix® SGX 5150 MD Type A
to type C USB cable
3 Mini USB port
Mini USB port; for technical
support use
2.3.4. Display Screens
The monitor provides a number of options for the display screen, in order
to meet needs of different users and institutions.
All of these screens present numeric data; some present graphical data
such as waveforms alongside the numeric data.
When the numeric data for a parameter displays - - (two dashes) instead of
a number, this indicates that data for that parameter is not available.
2.3.5. Monitoring Display Screen Options
The monitor provides a number of monitoring display screen options, as
listed below. Default Home Screen Display #1 will appear when the device
is turned on for the first time. By default, Home Screen Displays 1, 2, and 3
will be available when the device is turned on for the first time. To toggle
between the screen options, press the right or left directional arrows on the
Enter button.
A different Home Screen Display option may be selected as a default using
the Institutional Defaults option; this is described in 11.1.7 Home Screen
Configuration on page 318.
The Default Home Screen Display #1 will appear when the Home button on
the front of the monitor is pressed; likewise, if a different Home Screen
Buttons, Indicators and Connections
44
Capnostream™35 Portable Respiratory Monitor
Display option is selected as the default, that is the screen that will appear
when the Home button is pressed. That default home screen is marked
with a home icon ( ) next to the text HOME on the screen.
If SPD (Saturation Pattern Detection; reference 4.11.4 OxiMax™ SPD Alert
Management Technology on page 114) is enabled, it will appear in the SpO
section of the screen, when it is available as described in 4.11.4 OxiMax™
SPD Alert Management Technology.
2
1. Display Mode Default #1: EtCO
and SpO
waveforms (this is the factory default for Default Home
2
, RR, SpO2, and PR values with CO2
2
Screen)
2. Display Mode Default #2: Numeric Home screen without IPI
3. Display Mode Default #3: EtCO
, RR, SpO2, and PR values with IPI
2
trend graph
4. Display Mode Default #4: EtCO
and RR values with CO2
2
waveform
5. Display Mode Default #5: EtCO
, RR, SpO2, and PR values with CO2
2
waveform
6. Display Mode Default #6: EtCO
, RR, SpO2, and PR values with
2
SpO2 waveform
7. Display Mode Default #7: EtCO
waveform
SpO
2
, RR, SpO2, PR, and IPI values with
2
8. Display Mode Default #8: EtCO2, RR, SpO2, PR, and IPI values with
waveform
CO
2
9. Display Mode Default #9: EtCO2, SpO2, ODI, RR, A/hr, and PR
values with IPI trend graph
10. Display Mode Default #10: SpO
SatSeconds™ alarm management parameter and OxiMax™ SPD
alarm management parameter (where applicable), with SpO2
waveform.
Examples are shown in the screens below.
, RR, and PR values along with
2
Buttons, Indicators and Connections
Capnostream™35 Portable Respiratory Monitor
45
Note that examples of a standard home screen and a home screen with
Nellcor™ RR (also known as pulse-oximetry-derived respiration rate) and
OxiMax™ SPD are seen for the Home Screen #1. For all other home screens,
one type or the other is shown. For more information about these features,
see 4.11 Pulse Oximetry with the monitor on page 108.
Note:
Note the lung icon that appears next to the EtCO
texts, indicating that this data is derived from capnography,
which measures patient respiration, and the heart icon that
appears next to the SpO
is derived from pulse oximetry, which measures data using
the patient's pulse. If the device is showing respiration rate
data derived from pulse oximetry, a heart icon will appear
next to the RR text. For more information, reference 4.11.3
Nellcor™ Respiration Rate on page 109.
Figure 5. Home Screen Display #1, Standard
1 2 5
data, which indicates that this data
2
3
and RR
2
4
7
6 8
Buttons, Indicators and Connections
46
Capnostream™35 Portable Respiratory Monitor
Label Function Description
1 Power indicators Indicates power level of batteries
and connections status of power
cord
2 Message area
Area in which alarm and other
messages appear
3 CO2 waveform Display of patient CO2 values in
waveform format
4 EtCO2 patient data Current patient etCO2 patient data
5 RR patient data Current patient RR patient data
6 PR patient data Current patient PR patient data
7 SpO2 patient data Current patient SpO2 patient data
SpO
8
(plethysmograph)
2
waveform
Display of patient SpO2 values in
waveform format
Buttons, Indicators and Connections
Capnostream™35 Portable Respiratory Monitor
47
Figure 6. Home Screen Display #1, with Nellcor™ RR and OxiMax™ SPD Alert
3 4 1 2 5
9
7
Label Function Description
1 Power indicators Indicates power level of batteries
and connections status of power
cord
6 8
2 Message area Area in which alarm and other
3 CO2 waveform section No display of patient CO2 values in
4 EtCO2 patient data
section
5 Nellcor™ RR patient
data
messages appear
waveform format is shown, since
sampling line is connected
no CO
2
No current patient etCO2 patient
data is shown, since no CO
2
sampling line is connected
Current patient RR patient data
based on pulse oximetry; note
heart icon
Buttons, Indicators and Connections
48
Capnostream™35 Portable Respiratory Monitor
6 PR patient data Current patient PR patient data
7 SpO2 patient data Current patient SpO2 patient data
8 SatSeconds™ and
OxiMax™ SPD alert
indicators
9 SpO2 (plethysmograph)
waveform
SatSeconds™ and OxiMax™ SPD
alert indicators, with current
patient data below
Display of patient SpO2 values in
waveform format
Figure 7. Home Screen Display #2
1 2 3 4 7 6
5
Label Function Description
1 Power indicators Indicates power level of batteries
2 Message area
and connections status of power
cord
Area in which alarm and other
messages appear
Buttons, Indicators and Connections
Capnostream™35 Portable Respiratory Monitor
49
3 EtCO2 patient data
section
No current patient etCO2 patient
data is shown, since no CO
2
sampling line is connected
4 RR patient data
Current patient RR patient data;
note the heart icon, indicating
that this data is derived from
pulse oximetry
5 SatSeconds™ and
OxiMax™ SPD alert
indicators
SatSeconds™ and OxiMax™ SPD
alert indicators, with current
patient data below
6 SpO2 patient data Current patient SpO2 patient data
7 PR patient data Current patient PR patient data
Buttons, Indicators and Connections
50
Capnostream™35 Portable Respiratory Monitor
Figure 8. Home Screen Display #3
3 6 1 4 5 2
7 8
Label Function Description
1 Power indicators Indicates power level of batteries and
connections status of power cord
2 EtCO2 patient data Current patient etCO2 patient data
3 Message area Area in which alarm and other
4 RR patient data Current patient RR patient data
5 SpO2 patient data Current patient SpO2 patient data
6 PR patient data Current patient PR patient data
7 IPI value Current patient Integrated Pulmonary
8 IPI trend waveform
messages appear
Index™ (IPI) algorithm value
Integrated Pulmonary Index™ (IPI)
algorithm for current patient as a
trend in waveform format
Buttons, Indicators and Connections
Capnostream™35 Portable Respiratory Monitor
51
Figure 9. Home Screen Display #4
3
2
Label Function Description
4 1
5
1 Power indicators Indicates power level of batteries and
connection status of power cord
2 Message area Area in which alarm and other messages
appear
3 EtCO2 patient
data
4 RR patient data Current patient RR patient data
5 CO2 waveform
Current patient etCO2 patient data
Display of patient CO
format
values in waveform
2
Buttons, Indicators and Connections
52
Capnostream™35 Portable Respiratory Monitor
Figure 10. Home Screen Display #5
1 3 4 2 6 7
8
5
Label Function Description
1 Power indicators Indicates power level of batteries
and connections status of power
cord
EtCO
2
patient data
2
section
3 Message area Area in which alarm and other
4 RR patient data Current patient RR patient data;
5 SatSeconds™ and
OxiMax™ SPD alert
indicators
No current patient etCO2 patient
data is shown, since no CO
2
sampling line is connected
messages appear
note the heart icon, indicating
that this data is derived from
pulse oximetry
SatSeconds™ and OxiMax™ SPD
alert indicators, with current
patient data below
Buttons, Indicators and Connections
Capnostream™35 Portable Respiratory Monitor
53
6 SpO2 patient data Current patient SpO2 patient data
7 PR patient data Current patient PR patient data
8 CO2 waveform No display of patient CO2 values
in waveform format is shown,
since no CO
sampling line is
2
connected
Figure 11. Home Screen Display #6
1 3 4 2 5 6
Label Function Description
1 Power indicators Indicates power level of batteries
2 EtCO2 patient data Current patient etCO2 patient
3 Message area Area in which alarm and other
7
and connections status of power
cord
data
messages appear
Buttons, Indicators and Connections
54
Capnostream™35 Portable Respiratory Monitor
4 RR patient data Current patient RR patient data
5 SpO2 patient data Current patient SpO2 patient data
6 PR patient data Current patient PR patient data
7 SpO2 (plethysmograph)
waveform
Display of patient SpO2 values in
waveform format
Figure 12. Home Screen Display #7
1 3 4 2 5 7 6
Label Function Description
1 Power indicators Indicates power level of batteries
2 EtCO2 patient data Current patient etCO2 patient
8
and connections status of power
cord
data
Buttons, Indicators and Connections
Capnostream™35 Portable Respiratory Monitor
55
3 Message area Area in which alarm and other
messages appear
4 RR patient data Current patient RR patient data
5 SpO2 patient data Current patient SpO2 patient data
6 PR patient data Current patient PR patient data
7 IPI value Integrated Pulmonary Index™ (IPI)
algorithm value for current
patient
SpO
8
(plethysmograph)
2
waveform
Display of patient SpO2 values in
waveform format
Figure 13. Home Screen Display #8
1 3 4 2 5 7 6
8
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Capnostream™35 Portable Respiratory Monitor
Label Function Description
1 Power indicators Indicates power level of batteries
and connections status of power
cord
2 EtCO2 patient data Current patient etCO2 patient data
3 Message area
Area in which alarm and other
messages appear
4 RR patient data Current patient RR patient data
5 SpO2 patient data Current patient SpO2 patient data
6 PR patient data Current patient PR patient data
7 IPI value
Current patient Integrated
Pulmonary Index™ (IPI) algorithm
value
8 CO2 waveform Display of patient CO2 values in
waveform format
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57
Figure 14. Home Screen Display #9
1 3 4 2 5 8 7 6
9
10
Label Function Description
1 Power indicators Indicates power level of batteries and
2 EtCO2 patient data Current patient etCO2 patient data
3 Message area Area in which alarm and other
4 SpO2 patient data Current patient SpO2 patient data
5 ODI patient data Current patient Oxygen Desaturation
6 RR patient data Current patient RR patient data
7 A/hr patient data Current patient Apneas per hour data
connections status of power cord
messages appear
Index data
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Capnostream™35 Portable Respiratory Monitor
8 PR patient data Current patient PR patient data
9 IPI patient data Current Integrated Pulmonary Index™
(IPI) algorithm data
10 IPI trend waveform Integrated Pulmonary Index™ (IPI)
algorithm value for current patient as
a trend in waveform format
Figure 15. Home Screen Display #10
1 3 4 2 5 7 6
Label Function Description
1 Power indicators Indicates power level of batteries and
2 SpO2 patient data Current patient SpO2 patient data
8
connections status of power cord
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Capnostream™35 Portable Respiratory Monitor
59
3 Message area Area in which alarm and other
messages appear
4 SatSeconds™
indicator
5
OxiMax™ SPD alert
indicator
6 RR patient data
SatSeconds™ indicator, with current
patient data below
OxiMax™ SPD alert indicator, with
current patient data below
Current patient RR patient data; note
the heart icon, indicating that this
value is derived from pulse oximetry
7 PR patient data Current patient PR patient data
8 SpO2
(plethysmograph)
Display of patient SpO
waveform format
values in
2
waveform
The user may change the display screen as follows:
1. When the device is turned on, the Display Default Home Screen
#1 will appear.
2. On the Home screen, click the right directional arrow on the
Enter button.
3. The Default Home Screen #2 will now appear.
4. On the Home screen, click the right directional arrow on the
Enter button.
5. The Default Home Screen #3 will now appear.
6. Click the right directional arrow on the Enter button again to
cycle through the Home screen options again.
7. The chosen Home Screen will be displayed until the monitor is
turned off. When the monitor is turned on again, the Display
Default Home Screen #1 will appear.
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Capnostream™35 Portable Respiratory Monitor
8. To choose a different Home Screen Display option as a default, so
that it remains the default even after the device is turned off, use
the Institutional Defaults option; reference 11.1.7 Home Screen
Configuration on page 318.
2.3.6. Monitor Turn-off
To terminate operation of the monitor, take the following steps:
1. Remove the CO
and, if using a patient case, close the patient case.
2. Press the On/Off button for 2-3 seconds to turn off the monitor.
sampling line and SpO2 sensor from the patient
2
2.3.7. Screen Navigation
To move around the screen:
1. Use the directional arrows on the Enter/Navigation button to
move around the screen.
2. When the screen shows a choice of options/parameters which
may each be adjusted to display a list of choices, a frame will
appear around the selected section. Click Enter to select the
option/parameter for which you want to make changes. You may
now use the up and down arrows to make your selection.
Figure 16. Sample Parameters Adjustment Screen
Note the inactive arrows on the left and the active arrows with the shape
change on the right.
Letters and numbers may be entered as follows:
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Capnostream™35 Portable Respiratory Monitor
61
1. When the cursor is located in a section of the screen in which
letters or numbers may be added, click Enter and a keyboard will
appear on the screen.
2. Navigate within the keyboard using the directional arrows. When
you have moved the cursor to the letter/number which you want
to input, click Enter.
3. When the data input is completed, navigate to Done and click
Enter.
For setting time, date and other changes, reference 2.3.8 Date, Time,
Language, and Other Options, below.
2.3.8. Date, Time, Language, and Other
Options
Date and time may be changed as follows:
1. Click the Menu button on the front panel.
2. The first option in the menu is Setup>Alarm Setup. Click the
down arrow on the Enter button to navigate to System Setup
and click Enter.
3. Use right arrow to navigate to Date and Time and click Enter.
4. Select the first item you want to update and click Enter.
5. Using directional arrows, navigate to the value you want to
display and click Enter. Make the desired change and click
Enter.
6. To make additional changes, navigate to the next item you want
to update, and repeat.
7. When you are done, navigate to the Apply window and click
Enter.
Languages and other options may be changed as follows:
1. Click the Menu button on the front panel.
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Capnostream™35 Portable Respiratory Monitor
2. The first option in the menu is Setup>Alarm Setup. Click the
down arrow on the Enter/Navigation button to navigate to
System Setup and click Enter.
3. Use the right arrow and the down arrow to navigate to the
desired item and click Enter.
4. Using directional arrows, navigate to the value you want to
display and click Enter. Make the desired change and click
Enter.
5. To make additional changes, navigate to the next item you want
to update, and repeat.
6. Return to the home screen using the Home button to implement
the changes.
Table 2. Display Options Available on System Screen
Parameter Default Options
Date and Time NA NA
Language English
Event Marking
Mode
Graphical Trend
Display
Tabular Trend
Increment Display
Graphical Trend
Display Mode
English, French,
German, Spanish, Italian,
Dutch, Swedish,
Norwegian, Japanese,
Russian, Chinese,
Korean, Finnish, Polish,
Portuguese
Detailed Quick, Detailed
4 Hour 1,2,4,8,12, Hour
30 sec 1,5,15,30 sec, 1,5,15,30
Min, 1 hour
Recorded Calendar, Recorded
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Home Trend Display
View
Brightness Index Auto Auto, 1.2.3.4.5.6.7,8,9,10
1 Hour 1,2,4, Hour
Keyboard locking
The monitor keyboard may be locked by the user, perhaps to avoid
accidental changes by the patient or for another reason. Take the following
steps to lock the keyboard:
1. Press the Enter key for more than two seconds to lock the
keyboard. An on-screen message will indicate that the keyboard
is locked.
2. To unlock the keyboard when it is locked, press the Enter key for
more than two seconds. An on-screen message will indicate that
the keyboard is unlocked.
Screen timeouts
After one minute of no user interaction, all set-up type screens, except
screens in the service mode, will return to the screen that they were on last.
If a setup screen times out with a change having been in process, no
change is made.
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Capnostream™35 Portable Respiratory Monitor
2.3.9. Capnostream™35 Monitor
Operational Check Sheet
To get the monitor up and running quickly and smoothly, follow the list of
instructions below:
□ 1. Unpack the monitor
Remove the monitor and the accessories from the box.
Check that the items on the enclosed packing list are included.
□ 2. Install the battery pack
Refer to 3.2.2 Removable Battery Pack Installation on page 69 for installation
instructions.
□ 3. Turn on the monitor
Plug an AC adapter into the 12VDC port on the right side panel of the
monitor.
Plug the adapter cable into the mains AC supply.
The battery charging and power indicator at the front of the monitor will
turn on.
Press the Power ON/OFF button on the front panel to turn on the
monitor. The screen will light up, showing that the monitor is turned on.
□ 4. Change the date, time or language
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Capnostream™35 Portable Respiratory Monitor
65
□ 5. Set the Patient Type
□ 6. To toggle between the home screen options, click the
right/left button on the front panel navigational pad.
□ 7. Check Alarm Limits (Menu>Setup>Alarm
Setup>Select Alarm>Select Limit)
□ 8. Open a Patient Case (Menu>Actions>Patient
Admit)
□ 9. Connect a Sampling Line
Open the CO
monitor and connect the appropriate sampling line to the CO
at the top of this section.
Connect the sampling line to the patient as described in the Directions for
Use supplied with the sampling line. The sampling line connecter should
be screwed clockwise into the monitor CO
turned, to ensure that it is connected securely to the monitor. This will
assure that there is no leak of gases during measurement at the connection
point and that measurement accuracy is not compromised.
input connector shutter on the right side panel of the
2
□ 10. Connect a SpO
Connect the SpO2 extension cord firmly to the monitor SpO2 sensor port on
the left side panel of the monitor, and then connect the appropriate SpO2
sensor to the extension cord.
Connect the SpO
Use.
sensor to the patient as described in its Directions for
2
port until it can no longer be
2
Sensor
2
input port
2
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Capnostream™35 Portable Respiratory Monitor
□ 11. Once either sensor or both sensors are connected to
the monitor, it is ready for operation. Patient data should begin
appearing on the screen within a few seconds.
□ 12. View Trends if desired (Menu>Trend> Graphical
Trend or Tabular Trend)
□ 13. Set Up Data Transfer as required (if applicable;
connectivity accessories must be purchased separately)
(reference 5.4 Data Transfer on page 212).
3. Installation
This chapter describes the physical components of the monitor and how to
set up the monitor so it is ready for use.
3.1. Unpacking and Inspecting the Monitor
Unpack the monitor and check all the components before performing any
further procedures.
To unpack and inspect the monitor:
1. Carefully remove the monitor and the accessories from the box.
2. Check that the items on the enclosed packing list are included:
a. Monitor
b. Mains electrical power cord (AC cable)
c. AC adapter with DC cable
d. Removable battery pack
e. Operator’s manual
f. Monitor quick guide
g. CD with additional documentation (this manual in
additional languages)
3. Inspect each component.
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Capnostream™35 Portable Respiratory Monitor
If any component is damaged or missing, contact your local representative.
Please note that in some models the DC power cable is provided with a
two-color connector. When using such a cable, the connector should be
attached to the device with the lighter color and the arrow facing upwards.
When unpacking the monitor, dispose of packaging waste according to
local regulations for the disposal of packaging waste.
3.2. Batteries
3.2.1. Batteries
The device includes an internal battery, which is not accessible by the user,
and a removable battery pack. Both are lithium-ion batteries.
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 for more information.
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.
Caution:
Prolonged storage of the device above 60° C might cause
performance degradation of the batteries.
Batteries
Capnostream™35 Portable Respiratory Monitor
69
Note:
Ensure that both batteries are fully charged before each use
in EMS environments, based on the charger indicator LED at
the front of the monitor.
Note:
Before each use in EMS environments, inspect removable
battery contacts and remove any residue to ensure proper
connection when the removable battery is in use.
3.2.2. Removable Battery Pack Installation
The battery pack may be installed as follows:
1. Slide the battery pack into the battery pack compartment at the
bottom of the monitor, with label facing downwards, towards
the back panel of the monitor.
2. Push the battery pack in all the way, until a click is heard. The
battery pack is now installed.
3. The device is shipped with a battery that is not fully charged.
Before first use, charge the battery until the removable battery
indicator LED indicates that it is fully charged.
Figure 17. Monitor Bottom, with Battery Pack Installed
2
1
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70
Capnostream™35 Portable Respiratory Monitor
Label Function Description
1 Battery pack Battery pack installed in monitor
2 Black lever Black lever used to open the battery pack
compartment
3. To remove or switch the battery pack, open the battery pack
compartment of the monitor by pushing the black lever up
towards the front of the monitor.
4. The battery pack will release itself from the compartment. Pull
the battery pack out all the way.
Caution:
There should always be a removable battery installed in the
device. If the removable battery is not installed, the unit will
operate properly on AC power, and will operate on the internal
battery for a very limited period (for battery exchange/hot
swap purposes), but if AC power is lost for any reason, the
monitor will work only for a limited period, until the internal
battery’s charge is used up.
Caution:
Only the battery pack provided with this monitor shall be used
for the monitor. Other batteries may not operate correctly.
Caution:
The battery pack supplied with this monitor should not be used
with other devices.
The battery icons indicate the charge level of the batteries. Reference 3.2.5
Battery and AC Connections Indicators on page 72 for more details.
Batteries
Capnostream™35 Portable Respiratory Monitor
71
3.2.3. Battery and Power Usage
If power is lost when the monitor is operating from AC power, it
automatically switches to the removable battery pack for power. If the
removable battery pack is empty, the monitor includes an internal battery
which can supply power for a limited period while the user inserts another
removable battery pack or attaches the monitor to AC power.
The battery charging and power indicator at the front of the monitor ( )
indicates the battery/power status, as described in 3.2.5 Battery and AC
Connections Indicators on page 72.
The monitor can work using the removable battery pack for approximately
3 hours. The monitor can work using the permanent internal battery for 20
minutes. It is recommended to use the internal battery only for battery
switching periods and not for more extended use. Use of the internal
battery only for extended use may cause the device to power down.
WARNING:
When using the permanent battery only (that is, when the
external battery is not connected or completely depleted),
the Low Power alarm may display for less than 30 minutes
and an immediate shutdown may occur, due to a sudden
drop in permanent battery capacity. Please note that, as
described in 3.2.2 Removable Battery Pack Installation on page
69, there should always be a removable battery installed in
the device.
Both batteries will charge when the unit is plugged in. Charging time is up
to 5 hours when the unit is turned off, and up to 8 hours when the unit is
turned on. The removable battery may also be charged in the external
battery charger (see 8.2 Available Accessories on page 270).
The battery icons will show the approximate charge level of the removable
and permanent internal batteries. Reference 3.2.5 Battery and AC
Connections Indicators, below, for more details.
A Battery Low alarm appears when the removable battery charge level
falls below 30 minutes.
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Capnostream™35 Portable Respiratory Monitor
3.2.4. Battery Hot Swap
The monitor includes an internal permanent battery pack, to maintain
battery power during battery switching while the monitor is turned on but
not attached to AC power. Remove the removable battery pack as
described above and insert another battery pack.
When the monitor is attached to AC power, both the internal permanent
and the external removable battery packs will charge.
3.2.5. Battery and AC Connections
Indicators
The battery pack charge level and AC power connections should be
confirmed before each use.
Recharge the removable battery pack when the Battery Low alarm
appears on the display screen. To recharge the battery, make sure that the
monitor is plugged into the AC mains. The external battery charger may be
used for charging, but it will charge only the removable battery. It is best
practice to ensure that both batteries are fully charged.
The battery charging and power indicator at the front of the monitor ( )
indicates the battery/power status, as follows:
• The indicator is green when the monitor is connected to AC
power and both batteries are fully charged.
• The indicator is orange when the monitor is connected to AC
power and both batteries are currently being charged.
• The indicator is red when the monitor is connected to AC power
and both batteries are not being charged as the result of a
malfunction or another reason.
• The indicator is off (no light emitted from the indicator) when the
monitor is not connected to AC power.
An on-screen indicator ( ) will appear whenever the removable
battery is installed, indicating the current status of the removable battery.
Batteries
Capnostream™35 Portable Respiratory Monitor
73
Each of the five bars in the indicator indicates about 20% of the battery’s
charge level, so, for example, two bars on the indicator will inform the user
that the removable battery is at about 40% charge level. The indicator will
indicate a red bar when its charge level is low, flicker when its charge level
is very low, and show a diagonal line through the icon if the removable
battery is not charged or no removable battery is installed (reference 3.2.3
Battery and Power Usage on page 71).
An on-screen indicator ( ) will appear only if the internal battery bears a
charge of 50% or less. In this case, a hot swap of the removable battery
should not take place, and the device should be attached to AC power to
charge the internal battery. If the indicator appears even after the device is
attached to AC power, the device will need to be serviced; contact
Capnographytechnicalsupport@medtronic.com.
If the on-screen removable battery indicator ( ) does not change (to
indicate a reduction in capacity) during use with battery power only, and
the internal battery low power screen indicator ( ) appears, there may be
an issue with the removable battery. In this case, replace the removable
battery.
In addition, a Battery Low message in the message area will appear when
the removable battery charge level falls below 30 minutes; if both batteries’
charge level reach below critical levels, the monitor will display a message
indicating Battery empty, Shutting down in 30 seconds, and then
countdown to shutdown with an audible beep pattern. In this case,
immediate replacement of the removable battery and/or connection to an
AC power source is urgently required.
For normal operation, always check that the battery/power indicator is
green or orange during monitor use. This will ensure the battery is charged
during use and the monitor is prepared in case of a power outage. In the
case of a patient transfer, the unit can be unplugged and transferred with
the patient. Care should be taken to reconnect the monitor to the AC
mains following the transfer.
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Capnostream™35 Portable Respiratory Monitor
3.2.6. Handling the Battery Pack
Caution:
Do not immerse the removable battery pack in water; it may
malfunction.
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 may present a risk of fire or explosion.
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.
3.2.7. Storing the Battery
The removable battery should be stored outside the device. The battery
pack has an automatic discharge feature. You must periodically check the
charge level of the battery pack. The battery may be stored as follows:
The battery pack must be stored in a cold, dry area, not inside the monitor.
Its charge decreases over time. To restore the battery pack to full power,
recharge the battery before use.
Operation in EMS Environments
Capnostream™35 Portable Respiratory Monitor
75
Optimum storage for a removed battery is room temperature. The batteries
must be stored at the following temperature ranges:
• Less than 1 month: -20 to +50°C
• 1 month to 3 months: -20 to +40°C
• 3 months to 1 year: -20 to +20°C
3.2.8. Disposing of the Battery
Caution:
Do not dispose of the battery pack in fire; it may explode.
Follow local governing ordinances and recycling instructions regarding
disposal or recycling of batteries.
3.2.9. Internal Battery Pack
The internal battery pack is not removable and should not be handled by
the user.
3.3. Monitor Mounting Plate
The monitor may be attached to a 75mm VESA™* standard mounting plate
by attaching the VESA™* adapter assembly to the back panel of the
monitor. For more information, see the Mounting Adapter Kit directions for
use.
TM* Trademark of its respective owner.
3.4. Operation in EMS Environments
In EMS environments, the device should be used with battery power only.
Operation in EMS Environments
76
Capnostream™35 Portable Respiratory Monitor
The device is compatible with 2-bladed main-rotor helicopters with a rotor
frequency of 5-8 Hz (300-480 RPM) according to the parameters listed
in10.9 General Characteristics on page 286. For use with other types of
helicopters, please contact Capnographytechnicalsupport@medtronic.com.
The performance of the device was not tested in fixed-wing aircraft.
When installing the device in a helicopter for use during transport, please
note the following:
The device shall be mounted using a VESA™* mount and the monitor
mounting plate, positioned so that the bottom of the device is parallel to
the floor of the helicopter. The device shall be placed in a position where
the controls are easily reached by the caregiver, and the screen may be
viewed clearly by the caregiver.
If the monitor is connected to a Lantronix® device or connected to a
network via one of the adapter cables listed in 8.2 Available Accessories and
Spare Parts on page 270, it cannot be used in an EMS environment.
Note:
For use in EMS environments, Medtronic suggests storing an
extra removable battery with full capacity alongside the
monitor, to ensure the possibility of longer use of the
monitor without the need for an external power source.
Note:
Ensure that both batteries are fully charged before each use
in EMS environments, based on the charger indicator LED at
the front of the monitor.
Note:
Before each use in EMS environments, inspect removable
battery contacts and remove any residue to ensure proper
connection when the removable battery is in use.
Periodic Maintenance
Capnostream™35 Portable Respiratory Monitor
77
3.5. Periodic Maintenance
If your institution has a periodic maintenance database, log the monitor in
this database for its periodic regular maintenance and its calibration
procedure.
Regular maintenance is required every 24 months, starting from the
installation date.
Calibration is required after the first 1,200 hours of use (or 12 months,
whichever comes first) and thereafter every 4,000 hours of use (or 12
months, whichever comes first). The number of hours remaining until
calibration will appear on the monitor’s Service Screen. For more details
about calibration and other maintenance procedures, reference 6 Preventive
Maintenance on page 243.
4. Operation
4.1. Turning on the Monitor
This section explains how to turn on the monitor.
Caution:
The monitor is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs
and symptoms.
Caution:
Use only Microstream™ etCO2 consumables and Nellcor™ SpO2
sensors, to ensure that the monitor functions properly.
Note: Monitor should be fully charged before first
use, based on the charger indicator LED at the front of the
monitor.
Take the following steps to turn on the monitor:
1. Attach the AC adapter to the 12VDC connector port on the right
side of the monitor.
2. Attach the power cord to the AC adapter.
3. Plug the power cord into an external power source.
4. The battery/power indicator on the front of the monitor should
be either green or orange once the monitor is plugged in. If
Turning on the Monitor
Capnostream™35 Portable Respiratory Monitor
79
necessary, the monitor can work for a limited period of time on
battery power; reference 3.2.3 Battery and Power Usage on page
71 for details.
5. Press the On/Off button ( ) at the front of the monitor. The
monitor will turn on and the screen will light up. The yellow and
red alarm lights will light up briefly and a beep will be emitted by
the monitor speaker.
Caution:
If the battery charging and power indicator at the front of the
monitor ( ) is red or off, the monitor is running on battery
power only and will stop operating when the battery is
discharged.
Caution:
If the yellow and red alarm lights do not light up or there is no
sound from the speaker, the monitor should not be used and
should be sent for servicing.
6. The default mode for the device is the EMS-enabled mode, in
which the monitor will immediately be ready for monitoring,
once a CO
7. If EMS mode is disabled on the device, the monitor will display
the following on-screen message when turned on:
sampling line and an SpO2 sensor are attached.
2
Monitor Preparation for a Patient
80
Capnostream™35 Portable Respiratory Monitor
Figure 18. Trend Memory Message
8. In this case, click No to continue monitoring the same patient, or
click Yes if you are now monitoring a new patient and want to
clear any information regarding the previous patient to avoid
mix-ups. The monitor is now ready to begin monitoring, once a
CO2 sampling line and an SpO2 sensor are attached. If you want
to enable or disable EMS mode, reference 4.8.3 EMS Mode on
page 95.
9. Before attaching the monitor to a patient, check the date and
adjust to the current date if required, following the instructions in
2.3.8 Date, Time, Language, and Other Options on page 61.
4.2. Monitor Preparation for a Patient
Caution:
If any monitor response does not seem appropriate, do not use
the monitor. Instead, contact your local Service Center or
Capnographytechnicalsupport@medtronic.com.
The following steps describe the procedure for preparing the monitor for a
patient.
1. Connect the sampling line, the SpO
monitor, following the instructions in this manual. To connect the
sensor, or both to the
2
Monitor Preparation for a Patient
Capnostream™35 Portable Respiratory Monitor
81
sampling line and sensor, reference 4.10.2 FilterLine™ Sampling
Line Connection on page 101 and 4.11.2 Connecting an SpO2
Sensor to the monitor on page 109.
2. Once either or both the SpO
sensor and the sampling line are
2
connected to the monitor, it is ready for operation.
3. It is possible to use either the Capnography function (etCO
the Pulse Oximetry function (SpO
) individually. If you only want
2
to operate one function, connect ONLY the component for that
function, and the monitor will operate normally.
The monitor is for use with one patient at a time only.
4.2.1. Patient Types
There are six different patient types recognized by the monitor, listed
below.
• Infant/Neonatal: for patients from birth to the age of one year
• Pediatric 1-3 yrs: for patients aged one to three years
• Pediatric 3-6 yrs: for patients aged three to six years
• Pediatric 6-12 yrs: for patients aged six to twelve years.
• Adult 12-22: for patients aged 12 to 22 years
) or
2
• Adult 22+: For patients aged 22 years and up
The patient type is displayed at the top left-hand corner of the menu
screen.
The original default patient type on the monitor is ADULT 22+. The default
patient type may be changed in Institutional Defaults (reference 11.1.1
Changing Institutional Defaults on page 296.) The device will revert to the
default patient type every time the trend is cleared. (Stopping a case will
clear the trend memory and revert to the default patient type.) Other
actions, including boot-up in which the trend is not cleared, or opening a
new case, will retain the current patient type.
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Capnostream™35 Portable Respiratory Monitor
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.
To change the patient type:
1. Click the Menu button on the front panel.
2. The first option in the menu is Setup>Alarm Setup.
3. On the Setup Menu screen, navigate to the Patient Type Icon (on
the upper left of the Menu screen) using the directional arrows
and click Enter to open the drop-down menu.
Figure 19. Patient Type Drop-down List
4. Using the directional arrows, select the relevant patient type.
5. Select Enter and, if requested, Confirm, using the Enter button.
If there is a contradiction between the patient type and patient
age, check your patient data and change as required.
Patient Events
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83
4.3. Patient Cases and Patient ID Numbers
The monitor may be used for one patient at a time. It is recommended that
all patients should be recorded as patient cases, as described below.
1. Click the Menu button on the front panel.
2. On the Menu screen, navigate to and select Actions>Patient
Admit.
3. Change the automatically generated patient ID number (which
includes the current date according to the device and other
information - see Table 24. USB File Naming Convention on page
216) to a number that will identify the patient in your system, if
desired. The patient may also be identified with a case number,
also inputted on this screen.
4. Input patient data as required. Note that a patient case may be
opened even if you do not add patient data.
5. Navigate to and click the Start Case button on the left. A
window will notify you that a case has been started, and the text
on that button will change to Stop Case.
6. To stop a case that has already been started, navigate to the
same screen and click the Stop Case button. Note that stopping
a case will clear the trend memory and cause the device to revert
to the default patient type.
4.4. Patient Events
When scanning patient history in the monitor, it is often useful to have a
record of patient events that could have influenced the recorded readings.
Events are added to the patient trend record as follows:
1. Click the Menu button on the front panel.
Patient Events
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Capnostream™35 Portable Respiratory Monitor
2. On the Menu screen, navigate to and select Actions>Events.
The Event screen will open. Reference Figure 20. Event Marking
Screen on page 84.
3. The Medication Event list will be seen on the main screen; if you
want to add a Medication Event, navigate to the relevant event
and click Enter. If you want to add a PaCO
Intervention Event, navigate to the PaCO
, Patient or
2
, Patient or
2
Intervention buttons and click Enter. For PaCO2, navigate to
and set the date, time and number of PaCO
using the Enter
2
button. For a Patient or Intervention Event, navigate to and select
the desired event.
4. If you want to add a different event, navigate to and click the
Text Entry button and add free text, up to 20 characters, and
date and time for this event. This date and time may be in the
past.
5. Once you have inputted Event data, clicking Enter will return
you to the Home screen. If you decide not to input Event data,
click Back or Home to return to the Home screen.
Trend recording will continue as before; entering an event does not change
the trend recording status.
Figure 20. Event Marking Screen
The default event marking options in the monitor are as follows:
Alarm and Pulse Volumes and Alarm Delay
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85
Table 3. Event Markings
MEDICATION PATIENT INTERVENTION
Fentanyl EATING OXYGEN
Versed DRINKING SUCTION
Midazolam Coughing Adj Airway
Morphine Ambulating Narcan
Demerol Chest PT Romazicon
Propofol Turned Neb tx
Surfactant Snoring Stimulated
Medication-Other Patient-Other CO2 Insufflation
ABG
Intervention-Other
New events may be added and any of these event markings may be
changed, using Institutional Settings. Reference 11.1.1 Changing Institutional
Defaults on page 92 for more information.
4.5. Alarm and Pulse Volumes and Alarm Delay
WARNING:
Do not silence, pause or decrease the volume of the audible
alarm if patient safety may be compromised.
WARNING:
Do not decrease the volume of the audible alarm to a level
Alarm and Pulse Volumes and Alarm Delay
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Capnostream™35 Portable Respiratory Monitor
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.
The alarm volume can be made louder or softer for patient alarms and
pulse tone.
The monitor provides an optional pulse beep - a single beep which sounds
for each detected pulse. The pitch of the pulse beep signal changes with a
rise or fall in the patient’s blood O2 saturation level, with a higher tone
denoting a higher saturation level, and vice versa. The pulse tone can also
be turned off using the SpO
menu. By default, the pulse tone is turned off.
2
4.5.1. Alarm Volume
Follow the steps listed below to make the alarm volume louder or softer.
1. Click the Menu button on the front panel.
2. Navigate to and select the Setup>Volume Setup screen. Click
Enter and select the desired volume using the directional
arrows. Select Home to return to the Home screen while
retaining any changes you have made.
3. If the monitor is set to the Alarm Volume default setting, the set
volume will remain active when the monitor is turned off.
Other alarm volume options settable in Institutional Defaults are
Maximum and Audio Off. To change the Alarm Volume Institutional
Settings, reference 11.1.6.1 Main Monitor settings on page 313.
4.5.2. Pulse Tone and Button Click
Volume
The pulse tone and button click sound can be turned on or off as follows:
1. Click the Menu button on the front panel.
2. Navigate to and select Setup>SpO
Setup on the Menu Screen.
2
Alarm and Pulse Volumes and Alarm Delay
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87
3. Navigate to Pulse Tone and click Enter to view options. The
default value is Off. Navigate to On and click Enter to turn on
the pulse tone and button click sound.
4. This will return you to the SpO
return to the Home screen.
The pulse tone and button click volume can be set as follows:
1. The volume can be adjusted whether or not the Pulse Tone has
been turned on as described above.
2. Click the Menu button on the front panel.
3. Navigate to the Setup >Volume Setup screen. Click the down
arrow to navigate to the Pulse Volume section of the screen. Click
Enter and select the desired volume using the directional
arrows. Select Home to return to the Home screen while
retaining any changes you have made.
Setup screen. Select Home to
2
4.5.3. Alarm Volume Default Options
WARNING:
The Audio off option (which will create permanent audio
alarm off until reversed) should be set in the Institutional
Defaults only in a situation in which the caregiver is also
monitoring the patient by other means. When installing the
monitor as part of hospital's remote monitoring system,
continuous wireless transmission of data/alarm signals is
not guaranteed. It is therefore advised that, when setting
permanent audio off mode while using the monitor with a
remote monitoring system, extra care for operator-patient
proximity is in place in order to assure operator awareness
to the onset of alarm signals.
4.5.4. Alarm Delay
Alarm delay may be set for all patient alarms except for the No Breath and
SatSeconds™ alarms, using the following steps:
Use of Scavenging System
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Capnostream™35 Portable Respiratory Monitor
1. Click the Menu button on the front panel.
2. Setup will already be selected on the Menu screen. Navigate to
and select Service on the Setup Menu Screen.
3. Enter Service password (reference 6.4 Monitor Service Password on
page 245) and select Done.
4. Navigate to Institutional Defaults>Alarms>Alarm Delay.
5. Navigate to and select Enter on the relevant alarm.
6. Navigate and select to the desired alarm delay. Click Enter.
7. Select Home to return to the Home Screen.
8. The device will ask you to save settings and shut down. Click
Shutdown to shut down and then restart to retain the settings
change you have just made.
If the SatSeconds™ option is selected and the SatSeconds™ value triggers
alarm, any SpO2 delay that has been set will be superseded and the
an SpO
2
alarm will occur despite the SpO2 delay.
4.6. Use of Scavenging System
When using the monitor with anesthetics, nitrous oxide or high
concentrations of oxygen, connect the gas outlet to a scavenger system.
The gas output is a barbed style connector intended for 3/32-inch ID
tubing.
The gas outlet may be seen in Figure 3. Monitor Right View on page 40.
Use of Pump Off Mode
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89
4.7. Use of Pump Off Mode
Use the Pump Off mode whenever performing suction or lavage. During
Pump Off mode, pump activity is suspended to protect the monitor from
drawing in liquids which could cause a malfunction.
In the Pump Off mode, the CO
time to prevent liquids from entering the monitor.
module pump is switched OFF for a preset
2
WARNING:
If at any time the monitor displays the FilterLine Blockage
message, replace the sampling line.
Set the pump mode as follows:
1. The monitor must be currently monitoring CO
placed in Pump Off mode.
2. Click the Menu button on the front panel.
3. Navigate to and select Actions on the menu screen and Pump
Off on the Actions menu screen. Click Enter.
4. The monitor will indicate, in the CO
the time remaining until the pump will automatically turn back
on.
5. The standard Pump Off period is 15 minutes. This may be
changed in the CO
is turned off; reference 4.10.4 Adjustable CO2 Parameters on page
104), or in the Institutional defaults screen (permanently;
Reference 11.1.1 Changing Institutional Defaults on page 92.)
Setup screen (temporarily, until the monitor
2
area and the message area,
2
in order to be
2
6. To turn the CO
passed, click the menu button on the front panel and then
navigate to and select Pump Off for xx:xx – Exit Now.
7. To extend the timer for another Pump Off period, beyond the
current period, click the menu button on the front panel and
then navigate to and select Extend Timer. Clicking the Extend
pump back on before the set time period has
2
Additional Monitor Modes
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Capnostream™35 Portable Respiratory Monitor
Timer button will begin another Pump Off period of the same
length as the set Pump Off period.
While the pump is off, CO
or capnography-based respiration rate number values are displayed. SpO2,
pulse rate, and pulse-oximetry-based respiration rate monitoring continue.
is not monitored and no CO2 waveform, etCO2,
2
4.8. Additional Monitor Modes
4.8.1. Demo Mode
Access the Demo Mode as follows:
1. Click the Menu button on the front panel.
2. Setup will already be selected on the Menu screen. Navigate to
and select Service on the Setup Menu Screen.
3. Enter Service password (reference 6.4 Monitor Service Password on
page 245) and select Done.
4. Navigate to and select Demo Mode. Navigate to and select the
desired demo patient type option. Click Enter.
5. After a brief waiting period, the monitor will move to Demo
Mode. An on-screen message indicating Demo Mode can be
seen on the upper right, next to the time and date, in black text
on a yellow background.
6. To exit Demo Mode, turn off the monitor. When the monitor is
restarted, it will no longer be in Demo Mode.
No patient monitoring will take place while the monitor is in
Demo Mode, even if a sampling line and sensor are attached
to the monitor. To return to monitoring, turn off the monitor
and restart it.
Note:
Additional Monitor Modes
Capnostream™35 Portable Respiratory Monitor
91
Note:
The SPD alert feature will not be available in the Demo
Mode.
When a device is in Demo Mode, the trend data in the device will not be
erased. However, if trend data is viewed while the device is in Demo Mode,
the trend data displayed will be the Demo data. When the device is turned
off and turned on again, the device will show the previous patient’s trend
data, if the user has not cleared it (by choosing Yes when the device asks
whether to clear trend data). For the period of time during which the Demo
mode was viewed on the screen, no data will be available, since no data is
recorded while the device is in Demo mode.
4.8.2. Parameter Standby Mode
The monitor may be placed in a separate parameter standby mode for
capnography and/or for pulse oximetry. The purpose of this option is to
enable the user to turn off the alarm that sounds when a sampling
line/sensor is removed from the monitor at will. Once the monitor is in
Parameter Standby Mode, that mode can be activated as required.
By default, Parameter Standby Mode is enabled.
In both Standard Mode (when Parameter Standby Mode is not enabled)
and Parameter Standby Mode, removing a sampling line or SpO
sensor/extension cable from the monitor will cause a message to appear
on the screen (FilterLine Disconnected or SpO
Disconnected, as relevant) and cause an alarm to sound. Removing the
sensor from the patient will set off an audible alarm and an on-screen
SpO
2
message. The purpose of this alarm is to prevent unauthorized
disconnection of a sampling line/SpO2 sensor from the monitor, perhaps by
patients or patients’ visitors.
When there is no CO
(for pulse oximetry) connected to the monitor, the relevant Parameter
Standby Mode may be activated (as described below). Once it is activated,
there will be no audible alarms for the relevant parameter.
If Parameter Standby Mode is enabled, it may be activated as follows:
sampling line (for capnography) or no SpO2 sensor
2
Sensor
2
2
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Capnostream™35 Portable Respiratory Monitor
1. Remove the sampling line and/or SpO2 sensor from the monitor
or remove the SpO2 sensor from the patient.
2. Press the audio alarm paused hard key at the front of the
monitor ( ) for more than two seconds to enter the
Parameter Standby Mode.
3. The monitor will emit the Standby pattern beep when the
monitor is successfully placed in Parameter Standby Mode, and
the monitor screen will indicate the following messages in the
waveform areas (and in the message areas, alternately with other
relevant messages): CO
sampling line is connected to the monitor, the Parameter Standby
If a CO
2
Standby, SpO2 Standby.
2
Mode for CO2 will not open even if the audio alarm paused key is pressed
as required. Likewise, if an SpO
sensor is connected to the monitor and to
2
a patient, the Parameter Standby Mode for SpO2 will not open even if the
audio alarm paused key is pressed as required. This is to prevent entering
this mode while a patient is being monitored. Pressing the audio alarm
paused key will therefore start Parameter Standby Mode for both CO
if both are disconnected, or for one if only one is disconnected.
SpO
2
and
2
Please note the following:
• CO2 standby will be exited automatically when a CO2 sampling
line is attached to the monitor.
• SpO
attached to the monitor and to a patient.
Thus, if the user is unaware that the monitor is in the Parameter Standby
mode, simply reattaching a sampling line to the monitor or SpO
the patient will cause the monitor to exit the Parameter Standby mode and
monitoring to resume.
During Standby Mode, the current value of any parameter in standby will
be displayed as a double dash in the relevant area on the home screen.
standby will be exited automatically when an SpO2 sensor is
2
sensor to
2
Additional Monitor Modes
Capnostream™35 Portable Respiratory Monitor
93
Table 4. Message and Alarm Status during Different Parameter Standby
Situations
Feature Parameter Standby Situations
FilterLine
disconnected
(from monitor)
on-screen
message / SpO
sensor
disconnected
(from monitor)
on-screen
message
FilterLine
disconnected
(from monitor)
alarm / SpO
2
sensor
disconnected
(from monitor)
alarm
Status when
Parameter
Standby
mode
disabled
Status when
Parameter
Standby
mode
enabled but
not activated
Yes Yes Yes
2
No Yes No
Status when
Parameter
Standby mode
enabled and
Parameter
Standby
activated
SpO2 Sensor not
Yes Yes No
on Patient
Medium Priority
audible alarm
SpO2 Sensor not
Yes Yes Yes
on Patient onscreen message
Additional Monitor Modes
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Capnostream™35 Portable Respiratory Monitor
Feature Parameter Standby Situations
CO2 Standby
message / SpO
2
Standby message
High Priority
(patient) alarms
Flashing red and
yellow LEDs on
the front panel
during high
Priority (patient)
alarms
Status when
Parameter
Standby
mode
disabled
Status when
Parameter
Standby
mode
enabled but
not activated
Status when
Parameter
Standby mode
enabled and
Parameter
Standby
activated
No No Yes
Yes Yes No (for the
parameter in
standby), since
the patient is
not being
monitored
Yes Yes
No (for the
parameter in
standby), since
the patient is
not being
monitored
Storage or
transfer to remote
stations of high
priority (patient)
alarms
If you do not want to use Parameter Standby Mode, it may be disabled as
follows:
1. Click the Menu button on the front panel.
Yes Yes No (for the
parameter in
standby), since
the patient is
not being
monitored
Additional Monitor Modes
Capnostream™35 Portable Respiratory Monitor
95
2. Setup will already be selected on the Menu screen. Navigate to
and select Service on the Setup Menu Screen.
3. Enter Service password (reference 6.4 Monitor Service Password on
page 245) and select Done.
4. Select Institutional Defaults>Monitor.
5. Navigate to Parameter Standby Mode and click Enter. Set
Parameter Standby Mode to Disabled and click Enter.
6. Select Home to return to the Home Screen. The device will ask
you to save settings and shut down
7. Click Shutdown to shut down, and then restart to retain the
settings change you have just made.
4.8.3. EMS Mode
When the EMS mode is enabled, the following change will occur in the
monitor’s functioning:
• After powerup, the monitor immediately opens the home screen,
with no message regarding clearing trend memory for a new
patient.
• Likewise, after powerup, the monitor will start monitoring with
the most recently used patient type (not the default patient
type).
By default, the EMS Mode is enabled.
Disable the EMS Mode as follows:
1. Click the Menu button on the front panel.
2. Setup will already be selected on the Menu screen. Navigate to
and select Service on the Setup Menu Screen.
3. Enter Service password (reference 6.4 Monitor Service Password on
page 245) and select Done. Select Institutional
Defaults>Monitor>Factory Defaults.
Additional Monitor Modes
96
Capnostream™35 Portable Respiratory Monitor
4. Navigate to EMS Mode and click Enter.
5. Set to EMS Mode to Disabled and click Enter.
6. Select Home to return to the Home Screen. The device will ask
you to save settings and shut down; do so.
7. To enable the EMS mode, follow steps 1, 2, 3, 4 and 5 above. Set
EMS Mode to Enabled and click Enter.
8. Select Home to return to the Home Screen. The device will ask
you to save settings and shut down; do so.
4.8.4. Reminder Signal
When the monitor is set to Audio Off (Permanent Audio Alarm Off), a
reminder signal, which is a single beep, may be provided every two
minutes to indicate that the monitor is in a Permanent Audio Alarm Off
state.
By default, this Reminder Signal is Disabled.
Enable the reminder signal as follows:
1. Click the Menu button on the front panel.
2. Setup will already be selected on the Menu screen. Navigate to
and select Service on the Setup Menu Screen.
3. Enter Service password (reference 6.4 Monitor Service Password on
page 245) and select Done.
4. Select Institutional Defaults>Monitor.
5. Navigate to Reminder Signal and click Enter. Set Reminder
Signal to Enabled and click Enter.
6. Select Home to return to the Home Screen. The device will ask
you to save settings and shut down; do so.
7. When you restart, the Reminder Signal will be enabled.
Monitor Screen Menu Reference Chart
Capnostream™35 Portable Respiratory Monitor
97
4.9. Monitor Screen Menu Reference Chart
The chart below shows the menu flow paths for navigating through the
different screens of the monitor.
Figure 21. Monitor Menu Flow
Capnography with the Monitor
98
Capnostream™35 Portable Respiratory Monitor
4.10. Capnography with the Monitor
4.10.1. Microstream™ EtCO2 Consumables
Caution:
Before use, carefully read the Microstream™ etCO
consumables Directions for Use.
Caution:
Use only Microstream™ etCO
monitor functions properly.
consumables to ensure the
2
Caution:
Dispose of Microstream™ etCO
standard operating procedures or local regulations for the
disposal of contaminated medical waste.
consumables according to
2
2
Caution:
When monitoring with capnography during sedation, please
note that sedation may cause hypoventilation and CO2
waveform distortion or disappearance. Waveform attenuation
or disappearance is an indicator that the status of the patient’s
airway should be assessed.
Caution:
When monitoring patients during upper endoscopy, partial
blockage of the oral airway due to endoscope positioning or
during suction may cause periods of low readings and rounded
waveforms. The occurrence will be more pronounced with high
oxygen delivery levels.
Caution:
If CO2 insufflation is performed during CO2 monitoring, the
Capnography with the Monitor
Capnostream™35 Portable Respiratory Monitor
99
etCO2 values will accordingly rise very significantly and this
may result in device alarms and abnormally high waveforms
until the CO
is evacuated from the patient.
2
WARNING:
Microstream™ CO
patient use, and are not to be reprocessed. Do not attempt
to clean, disinfect, sterilize or flush any part of the sampling
line. Re-use of single-use accessories could pose a crosscontamination risk to the patient or damage the functioning
of the monitor.
consumables are designed for single
2
WARNING:
Loose or damaged connections may compromise ventilation
or cause an inaccurate measurement of respiratory gases.
Securely connect all components, turning the sampling line
connecter clockwise into the monitor CO
longer be turned. Check connections for leaks according to
standard clinical procedures, and ensure CO
port until it can no
2
WARNING:
If too much moisture enters the sampling line (i.e., from
ambient humidity, patient secretions, or breathing of
unusually humid air), the message Clearing FilterLine will
appear in the monitor message area. If the sampling line
(FilterLine™ sampling line) cannot be cleared, the message
FilterLine Blockage will appear in the CO
display section on the Home screen and in the monitor
message area. (If there is no waveform display, the message
will appear only in the message area.) Replace the sampling
line once the FilterLine Blockage message appears.
waveform
2
values appear.
2
WARNING:
sampling lines used with the monitor are marked as to
CO
2
the upper limit of oxygen that may be provided with the
sampling line. At levels of oxygen provision higher than
those marked on the sampling line packaging, dilution of
readings may occur, leading to lower CO2 values.
CO
2
Capnography with the Monitor
100
Capnostream™35 Portable Respiratory Monitor
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 with caution to
prevent combustion of the sampling line or surrounding
surgical drapes.
when
2
WARNING:
With non-intubated patients, inaccurate CO
ineffective O2 delivery (for infant patients) may occur if the
patient has clogged nares.
readings or
2
WARNING:
When used with a suction catheter, do not place the airway
adapter between the suction catheter and endotracheal
tube. This is to ensure that the airway adapter does not
interfere with the functioning of the suction catheter, and
that the suction process does not damage the airway
adapter. Damage of the airway adapter may harm the
patient.
Note:
During nebulization, lavage, or suction, suspend CO
activity as described in 4.7 Use of Pump Off Mode on page 89,
in order to avoid moisture buildup and sampling line
occlusion. In addition, especially if unable to suspend the
pump, disconnect the sampling line connector from the
CO
2
CO2 port on the monitor.
Note:
Any serious incident related to device use that may occur
should be reported immediately to the manufacturer, the
local competent authority, and any other regulators as
required.
pump
2
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