Capnostream 20p Operators Manual PN 012194C

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. Oridion®, Microstream®, FilterLine, Smart CapnoLine®, CapnoLine®, Smart BiteBloc™, NIV Line™, CapnoBloc™, Smart CapnoLine Guardian™, SARA™, Integrated Pulmonary Index™, Capnostream®20p, Microcap®, Microcap® Plus, and VitalCap® are trademarks or registered trademarks of Oridion Medical 1987 Ltd. Nellcor Puritan Bennett LLC is a Covidien company. The following are trademarks of Nellcor Puritan Bennett LLC: Oxiband™; Durasensor™; OxiCliq®; Dura-Y™; Max-Fast™ and OXIMAX™. The capnography component of this product is covered by: US Patents: www.covidien.com/patents. The pulse oximetry component of this product is covered by: 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. Copyright © 2014 Oridion Medical 1987 Ltd. All rights reserved.

Table of Contents Table of Contents

1

List of Figures

8

List of Tables

9

Oridion Medical 1987 Ltd. ("Oridion Medical") - Warranty for Oridion Monitors

10

Safety Information

11

Warnings ... 11 General... 11 MRI Scanning... 12 Monitor Use with Defibrillators ... 12 Alarms ... 12 Fire Hazard... 12 Electrical ... 13 Electro-magnetic Interference ... 13

Definitions ... 14

Chapter 1

15

About this Manual

15

Overview ... 15 Intended Use ... 15 Specific Indications for Use ... 16 Who Should Read This Manual ... 16 Contacting Technical Support ... 16 Symbols ... 16

Chapter 2

19

Technology Overview

19

Introduction ... 19 Features ... 19 Technology Overview ... 19 What is Capnography? ... 19 What is Pulse Oximetry? ... 20

Chapter 3

21

The Capnostream Monitor

21

Unpacking and Inspection ... 21 Installing the Battery Pack ... 22 Testing the Battery and AC Connections... 23 Handling the Battery Pack ... 23 Portable Bedside Capnograph/Pulse Oximeter

1

Storing the Battery ... 24 Disposing of the Battery ... 24 Battery and Power Usage ... 24

Mounting the Monitor... 25 Setting up Periodic Maintenance... 25 Accessories ... 25 Available Accessories ... 25 Monitor Mounting Plate ... 26 Printer Paper ... 26

Buttons, Indicators and Connections ... 26 Monitor Front View ... 27

Front Panel Control Buttons ... 28 Monitor Rear Panel ... 29 Monitor Left and Right Views ... 30

Turning on the Monitor ... 30 Standard Sections of the Display Screen ... 31 Home Screen Standard Display... 32 Home Screen Numeric Display ... 36

Terminating Operation of the Monitor ... 37 Screen Navigation ... 37 Configuration Changes ... 38

Setting Date, Time, Language, and Other Options ... 38 Screen Timeouts ... 39 Screen Timeouts ... 39

Capnostream®20p: Operational Check Sheet ... 40

Chapter 4

43

Using the Capnostream Monitor

43

Preparing the Monitor for a Patient ... 43 Setting the Patient Type ... 43

Using Patient Cases and Patient ID Numbers... 44 Entering Patient Events ... 46 Changing the Alarm and Pulse Volumes ... 46 Alarm Volume ... 46 Pulse Tone Volume ... 47 Alarm Volume Default Options... 47

Alarm Delay ... 48 Use of Scavenging System ... 48 Turning the Pump Off for Suction or Lavage ... 48 Demo Mode... 49 Monitor Screen Menu Reference Chart ... 49

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Portable Bedside Capnograph/Pulse Oximeter

Chapter 5

53

Capnography with the Capnostream Monitor

53

Microstream® EtCO2 Consumables ... 53 Basic Principles ... 53 Microstream® EtCO2 Consumables ... 54

Connecting a FilterLine ... 54 CO2 Data Displayed by the Capnostream Monitor ... 54 Adjustable CO2 Parameters ... 55 Monitoring CO2 during MRI Scanning ... 56

Chapter 6

57

Pulse Oximetry with the Capnostream Monitor

57

Nellcor SpO2 Sensors ... 57 Data Update Period, Data Averaging, and Signal Processing ... 58 Selecting Nellcor SpO2 Sensors ... 58 Performance Considerations ... 59

Connecting an SpO2 Sensor to the Monitor... 60 SpO2 Data Displayed by the Capnostream Monitor ... 60 Adjustable SpO2 Parameters... 62 SPO2 Alarm Limit Message ... 62

Chapter 7

63

Integrated Pulmonary Index™

63

Introduction ... 63 Warnings ... 64 IPI Display ... 64 IPI Options ... 64

Chapter 8

65

Apneas per Hour and the Oxygen Desaturation Index

65

Introduction ... 65 Apneas per Hour ... 65 The Capnostream Apneas per Hour ... 65 A/hr Visual Alert ... 66

Oxygen Desaturation Index (ODI) ... 66 Apnea and O2 Desaturation Report ... 66 Monitoring with A/hr and ODI ... 66 Smart A/hr and ODI Home Screen Display ... 67 A/hr and ODI Option ... 67 A/hr and ODI Demo Mode ... 67

Portable Bedside Capnograph/Pulse Oximeter

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Chapter 9

69

Alarms and Messages

69

Introduction ... 69 Alarm Display ... 70 Message Priorities ... 72 Alarm Delay ... 72 Types of Alarms ... 72 High Priority Alarms ... 73 Medium Priority Alarms ... 74 Advisories ... 75 Silent Advisories ... 75

Parameter Standby Mode ... 76 Alarm Silence ... 78 Changing Alarm Limits ... 79 Testing Alarm Settings ... 80 SpO2 Alarms and SatSeconds ... 80 SatSeconds Alarm Display ... 81

Alarm Limits - Factory Defaults ... 82

Chapter 10

83

Using Trends

83

Introduction ... 83 The Trend Display Screens ... 84 Graphical Trend Display Screen ... 84 Graphical Trend Display... 84 Using SCROLL and ZOOM ... 85

Tabular Trend Display Screen... 87 Choosing Trend Parameters ... 89 Important Notes Regarding Trend Reports ... 89 Specific Events as seen in Trend Data... 89 Using the Graphical Trend Screen for Monitoring Patients ... 89 Printing the Trend Data ... 89 Clearing Trend Memory... 90 Configuring Trends... 90 Event Marking Mode ... 91 Trend Graphical Display... 91 Trend Increment Display ... 91

Chapter 11

93

Reports

93

Apnea and O2 Desaturation Report ... 93 Printed Report Options ... 97 Printed Reports ... 97 4

Portable Bedside Capnograph/Pulse Oximeter

Sample Reports... 101 Sample Case Reports ... 101 Sample Trend Reports ... 102

Chapter 12

103

Downloading Patient Data

103

Introduction ... 103 Data Transfer via the USB Data Port ... 103 USB File Naming Convention ... 106 Examples... 106 USB Error Messages ... 107 Reading Patient Data from Saved Capnostream Files... 107

Data Transfer via the RS-232 Port ... 107 Analog Data Output with Capnostream ... 107 Nurse Call Operation ... 107 Types of Nurse Call Systems ... 108 The Nurse Call Cable ... 108 Activating Nurse Call ... 109 Testing Nurse Call... 109

Operation with Hospital Patient Data Systems ... 110 Operation with Nuvon VEGA Systems ... 110

Chapter 13

111

Maintenance and Troubleshooting

111

Introduction ... 111 Determining Monitor Service Hours... 111 CO2 Calibration ... 112 CO2 Calibration Check ... 113 Calibration Check Procedure ... 113

Maintenance ... 114 Replacing the Fuses... 114 Replacing the Printer Paper Roll ... 115 Cleaning ... 115 Troubleshooting... 116 Electrical ... 116 CO2 Problems ... 116 SpO2 Sensor ... 117 Printer ... 117 Nurse Call... 118 CO2 Calibration ... 118

Returning the Monitor ... 118 Technical Assistance... 118

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Appendix 1

119

Institutional Settings

119

Institutional Defaults ... 119 Changing Institutional Defaults... 119 Resetting to Factory Defaults ... 120 Uploading or Downloading Institutional Defaults ... 120 Changing Monitor Settings ... 121 Alarm Limits... 121 Alarm Delay ... 123 Trend Settings ... 123 Changing Parameters Order on the Trend Display ... 123 Events ... 124 How to Change Event Defaults ... 124 Monitor Settings ... 124 CO2 Parameters ... 126 SpO2 Parameters ... 126

Appendix 2

127

Specifications

127

Power Supply ... 127 Battery ... 127 Controls ... 127 Display ... 128 Microstream® Capnography ... 128 Nellcor Oximax® Pulse Oximetry ... 129 Alarms ... 129 Outputs... 129 Analog Output ... 129 Nurse Call... 130 RS-232 ... 131 USB ... 131

Internal Thermal Printer (optional) ... 131 General Characteristics ... 132 Equipment Classification ... 132 Compliance ... 132 Electromagnetic Immunity ... 132

Appendix 3

137

Microstream EtCO2 Consumables

137

Microstream EtCO2 Consumables... 137

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Portable Bedside Capnograph/Pulse Oximeter

Appendix 4

139

Capnostream Service Password

139

Capnostream Service Password ... 139

Portable Bedside Capnograph/Pulse Oximeter

7

List of Figures Figure 1 - Installing the Battery Pack ... 22 Figure 2 - Battery Pack Close-up ... 22 Figure 3 - Menu Bar with Battery Charge Level ... 23 Figure 4 - Monitor Bottom View ... 25 Figure 5 - Capnostream Front View ... 27 Figure 6 - Front Panel Control Buttons ... 28 Figure 7 - Capnostream Rear View ... 29 Figure 8 - Capnostream Left View... 30 Figure 9 - Salutation Screen ... 31 Figure 10 - Typical Home Screen... 32 Figure 11 - Typical Home Screen when A/hr and ODI are not Available ... 33 Figure 12 - Standard Home Screen without IPI Option ... 34 Figure 13 - Header Area ... 34 Figure 14 - Typical Numeric Home Screen ... 36 Figure 15 - System Setup Screen ... 39 Figure 16 - Menu Bar... 47 Figure 17 - Alarm Volume Selection... 47 Figure 18 - Pulse Tone Volume Selection... 47 Figure 19 - Scavenger System Connection Point ... 48 Figure 20 - Screen Menu Reference Chart when A/hr and ODI are available ... 50 Figure 21 - Screen Menu Reference Chart when A/hr and ODI are not available ... 51 Figure 22 - CO2 Data on the Capnostream Monitor... 54 Figure 23 - CO2 Section of Numeric Home Screen ... 55 Figure 24 - SpO2 Data on the Capnostream Monitor - Standard Screen ... 61 Figure 25 - SpO2 Data on the Capnostream Monitor – Standard Screen with IPI Disabled ... 61 Figure 26 - SpO2 Section of Numeric Home Screen ... 62 Figure 27 - IPI Trend Graph ... 63 Figure 28 - Capnostream Alarm Review Screen ... 71 Figure 29 - Example Showing Alarms ... 73 Figure 30 - Alarm Limits Screen ... 79 Figure 31 - Graphical Trend Display ... 84 Figure 32 - Scroll mode in the Graphical Trend ... 86 Figure 33 - Tabular Trend Display... 87 Figure 34 - Trend Memory Message ... 90 Figure 35 - Apnea and Desat Report Screen ... 95 Figure 36 - Apnea and Desat Printed Report ... 96 Figure 37 - Print Screen ... 98 Figure 38 - Sample Case Reports Printout ... 101 Figure 39 - Printed Trend Reports... 102 Figure 40 - Typical Flash Memory Device... 104 Figure 41 - USB Icon ... 105 Figure 42 - Stereo Phono Plug for Nurse Call... 108 Figure 43 - Connection Point for Nurse Call ... 109 Figure 44 - Service Screen ... 112 Figure 45 - Insert Paper Roll into printer ... 115 Figure 46 - Institutional Defaults Screen ... 120 Figure 47 - Software Support Screen ... 121 Figure 48 - Institutional Defaults Alarm Limits Screen ... 122 Figure 49 - Institutional Defaults: Monitor ... 125 8

Portable Bedside Capnograph/Pulse Oximeter

List of Tables Table 1 - Symbols that Appear on the Monitor ... 16 Table 2 - Capnostream Accessories ... 25 Table 3 - Printer Paper Specifications... 26 Table 4 - Capnostream Front View ... 28 Table 5 - Capnostream Rear View ... 29 Table 6 - Capnostream Left View... 30 Table 7 - Header Section ... 34 Table 8 - Event Markings ... 46 Table 9 - Audio Alarm Volume ... 47 Table 10 - Adjustable CO2 Parameters ... 56 Table 11 - Nellcor SpO2 Sensors ... 58 Table 12 - Adjustable SpO2 Parameters ... 62 Table 13 - Adjustable IPI Options ... 64 Table 14 - Alarm Indications... 69 Table 15 - High Priority Alarms ... 73 Table 16 - Medium Priority Alarms ... 74 Table 17 - Advisories ... 75 Table 18 - Silent Advisories... 75 Table 19 - Message and Alarm Status during Different Parameter Standby Situations ... 78 Table 20 - Tabular Display Example ... 88 Table 21 - Detailed Tabular Display Example... 88 Table 22 - Monitor Parameters... 90 Table 23 - Printed Reports – Parameters ... 98 Table 24 - Data Transfer Types ... 103 Table 25 - Select Data Output Type... 105 Table 26 - File Naming Conventions ... 106 Table 27 - Nurse Call Specs ... 108 Table 28 - Nurse Call Indicators ... 109 Table 29 - Factory Default Alarm/Indicator Limits ... 122 Table 30 - Factory Default and Optional Alarm Delay Settings ... 123 Table 31 - Factory Default and Optional Trend Settings ... 123 Table 32 - Guidance and Manufacturer's Declaration - Electromagnetic Emissions ... 133 Table 33 - Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ... 133 Table 34 - Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Monitor ... 135

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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 subject to misuse, mishandling, accident, alteration, neglect, unauthorized repair or installation; and (iii) 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.

Disclaimer USER MAY USE THE PARAMETERS (INCLUDING ANY AND ALL REFERENCES TO CO2, SPO2, CURRENT INTEGRATED PULMONARY INDEX™ 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. USER 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. USER 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 USER 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. USER 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. 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, OR OTHER SIMILAR DAMAGES 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.

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Portable Bedside Capnograph/Pulse Oximeter

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Safety Information Warnings Definitions

To use the Capnostream®20P monitor (henceforth referred to as Capnostream) correctly and safely, carefully read this operator’s manual and the Directions for Use that accompany Microstream® etCO2 consumables (FilterLines®, henceforth referred to as FilterLines) and the SpO2 sensors. Use of the monitor requires full understanding and strict observance of these instructions, the precautionary information in boldface type, and the specifications.

Warnings General 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:

The device should not be used as an apnea monitor.

WARNING:

The device should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter 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.

WARNING:

Carefully route patient cabling (SpO2 sensor and FilterLine) to reduce the possibility of patient entanglement or strangulation.

WARNING:

Do not lift the monitor by the SpO2 sensor cable or FilterLine, as they could disconnect from the monitor, causing the monitor to fall on the patient.

WARNING:

The monitor should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the monitor shall be observed to verify normal operation in the configuration in which it will be used.

WARNING:

To ensure accurate performance and prevent device failure, do not expose the monitor to extreme moisture, such as rain.

WARNING:

The use of accessories, transducers, sensors and cables other than those specified may result in increased emission and/or decreased immunity of the equipment and/or system.

WARNING:

Re-use of single-use accessories could pose a cross-contamination risk to the patient or damage the functioning of the monitor.

WARNING:

CO2 readings, respiratory rate, pulse oximetry readings, and pulse signals can be affected by sensor application errors, certain ambient environmental conditions, and certain patient conditions.

WARNING:

The monitor is a prescription device and is to be operated by qualified healthcare personnel only.

WARNING:

No modification of this equipment is allowed.

Portable Bedside Capnograph/Pulse Oximeter

11

Warnings

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.

Note:

Devices connected to the monitor must be medical grade only.

Note:

The accurate display of the following parameters is required in order to fill the essential performance of the device: Carbon dioxide levels in expired breath (CO2) and respiration rate when monitoring with capnography, and arterial oxygen 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.

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 during magnetic resonance imaging (MRI) scanning. Using the FilterLine H Set Infant/Neonatal during MRI scanning could harm the patient.

CAUTION:

During MRI scanning, the monitor must be placed outside the MRI suite. When the monitor is used outside the MRI suite, etCO2 monitoring can be implemented using the FilterLine XL. (Refer to Monitoring CO2 during MRI Scanning on page 56.

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 interference. The use of non-H sampling lines is advised. For a list of H sampling lines, see Microstream EtCO2 Consumables on page 137.

Monitor Use with Defibrillators 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 SpO2 sensors must be completely intact and undamaged, in order to enable use of a defibrillator with the monitor.

Alarms WARNING:

Do not silence the audible alarm if patient safety may be compromised.

WARNING:

Always respond immediately to a system alarm since the patient may not be monitored during certain alarm conditions.

WARNING:

Before each use, verify that the alarm limits are appropriate for the patient being monitored.

WARNING:

Check the audible alarm silence duration before temporarily silencing the audible alarms.

WARNING:

Auditory alarm signal sound pressure levels which are less than ambient sound levels can impede operator recognition of alarm conditions.

CAUTION:

Setting alarm limits to extreme values may impair the alarm system’s effectiveness.

Fire Hazard

12

WARNING:

When using the monitor with anesthetics, nitrous oxide or high concentrations of oxygen, connect the gas outlets 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.

Portable Bedside Capnograph/Pulse Oximeter

Warnings

WARNING:

The FilterLine may ignite in the presence of O2 when 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 flammability of the FilterLine or surrounding surgical drapes.

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:

Connect the device only to a three-wire, grounded, hospital grade receptacle. The threeconductor plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electrical code. Do not under any circumstances remove the grounding connector from the power plug. Do not use extension cords or adapters of any type. The power cord and plug must be intact and undamaged. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

WARNING:

Ensure that the monitor is positioned so that its mains plug is accessible for immediate disconnection from supply mains, when needed.

WARNING:

If there is any doubt about the integrity of the protective earth conductor arrangement, operate the device on internal battery power until the AC power supply protective conductor is fully functional.

WARNING:

Do not connect to an electrical outlet controlled by a wall switch or a dimmer.

WARNING:

Measure the device's leakage current whenever an external device is connected to the serial port. Leakage current must not exceed 100 microamperes.

WARNING:

To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective grounding.

WARNING:

Whenever the equipotential ground at the back of the device (reference Figure 7 Capnostream Rear View on page 29) is to be used, the user must connect to the pin in a way which will ensure that accidental disconnection is avoided.

WARNING:

In a facility which provides detachable potential equalization conductors, the Equipotential ground at the back of the device (reference Figure 7 - Capnostream Rear View on page 29) may be used for optional connection between the Capnostream and the potential equalization busbar of the electrical installation. The Equipotential ground at the back of the device should not be used for a protective earth connection.

WARNING:

Always connect power cord to the device first, and then plug the power cord into the wall outlet.

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.

CAUTION:

Keep power cord, plug and socket clear in case an urgent power supply disconnection is required.

Electro-magnetic Interference This device has been tested and found to comply with the requirements for medical devices according to the standard EN60601-1-2. 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),

Portable Bedside Capnograph/Pulse Oximeter

13

Definitions

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.

WARNING:

Do not use the monitor with nuclear spin tomography (MRT, NMR, NMT) as the function of the monitor may be disturbed.

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.

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Portable Bedside Capnograph/Pulse Oximeter

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Chapter 1

About this Manual Overview Intended Use Specific Indications for Use Who Should Read This Manual Contacting Technical Support Symbols

Overview This manual provides directions for setting up and operating the Capnostream monitor. The Capnostream is a portable bedside monitor that continuously monitors a patient’s:

• End tidal carbon dioxide (etCO2) - level of carbon dioxide in exhaled breath. • Respiratory rate (RR). • Fractional inspired carbon dioxide (FiCO2) - level of carbon dioxide present during inhalation. • Oxygen saturation (SpO2). • Pulse rate (PR). The device also provides an Integrated Pulmonary Index™ (henceforth referred to as IPI) value, which is a numerical value that integrates four major parameters measured by Capnostream in order to provide a simple indication of the patient’s ventilatory status. The integrated parameters are etCO2, RR, SpO2, and PR. Only these four parameters are used to calculate IPI; other parameters are not taken into account. In addition, the device provides the Apneas per Hour (A/hr) and an Oxygen Desaturation Index (ODI), used 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 and O2 Desaturation screen).

• ODI: the number of times that the SpO2 value dropped 4% or more from baseline and returned to baseline in 240 seconds or less, either in the last hour (on the Home screen) or average pauses per hour over a period of time (on the Apnea and O2 Desaturation screen). The A/hr and ODI indices are not available in all locations. In order to equip your device with the A/hr and ODI feature, contact [email protected].

Intended Use The Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital transport environments. Capnostream®20p is to be operated by qualified healthcare personnel only.

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Specific Indications for Use

The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Specific Indications for Use An additional indication of the monitor is to provide information to help in the identification of apnea and oxygen desaturation events in adult patients (age 22 and up) in hospital ICU and general floor environments, through the reporting of these events and calculation of the associated apnea per hour (A/hr) and oxygen desaturation index (ODI).

Who Should Read This Manual This manual should be read by:

• Health Care Professionals who will be using Capnostream. • 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 Capnostream to a computer via the RS-232 interface. WARNING:

In the United States, federal law restricts this device to sale by or on the order of a physician.

Contacting Technical Support For any technical issue involving the Capnostream monitor, please contact Oridion 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: [email protected].

Symbols The following symbols appear on the body of the monitor. Table 1 - Symbols that Appear on the Monitor

Symbol

Description Monitor ON/OFF button

AC power ON indicator

UNIT ON indicator

Event selection

Patient Admit/Discharge

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Portable Bedside Capnograph/Pulse Oximeter

Symbols

Symbol

Description Pump Off

Temporarily silence alarms

Type BF Defibrillator Proof Protection

General warning sign Gas inlet Gas outlet Equipotential ground USB flash memory connection port

CE Mark

For prescription use only Directive on waste electrical and electronic equipment

Follow instructions for use

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17

Chapter 2

Technology Overview Introduction Features Technology Overview

Introduction The Capnostream bedside monitor provides accurate, continuous capnography and pulse oximetry monitoring for intubated and non-intubated patients from neonate to adult. Using Microstream® technology, patented FilterLine® etCO2 consumables, and pulse oximetry technology, Capnostream allows for simultaneous "hassle free" etCO2 and SpO2 monitoring.

Features

• Dual parameter monitor that supports the current standard of care providing CO2 and SpO2 measurements • Integrated Pulmonary Index™ (IPI), which provides a simple, clear, and comprehensive indication of a patient’s ventilatory status and trends

• Apneas per Hour and Oxygen Desaturation Index, indices used to help in the identification and quantification of apnea and oxygen desaturation events (if available)

• Simple user interface with color screen • Routine functions are accessed with 2 clicks • 72 hour trends to review patient history • One-click alarm review • SARA™ (Smart Alarm for Respiratory Analysis), an embedded Smart Capnography alarm management technology, which reduces clinically insignificant alarms

• Event marking to compare events and medication administration to changes in patient status • Case recording to help organize patient files • Nurse call • Optional internal printer • USB output to transfer patient data to USB flash memory devices • Analog output for use in sleep labs and other laboratory environments • RS-232 port for data transfer Technology Overview This section provides a basic overview of Capnography and Pulse Oximetry. What is Capnography? Capnography is a non-invasive method for monitoring the level of carbon dioxide in exhaled breath (etCO2) to assess a patient’s ventilatory status. Capnostream uses Microstream® non–dispersive infrared (NDIR) spectroscopy to continuously measure the amount of CO2 during every breath, the amount of CO2 present at the end of exhalation (etCO2), the amount of CO2 present during inhalation (FiCO2), and the Respiratory Rate. Portable Bedside Capnograph/Pulse Oximeter

19