N-85 Portable Bedside Capnograph Pulse Oximeter Operators Manual PN 015440A 2012

Notice: Purchase of this instrument confers no express or implied license under any Oridion or Covidien patent to use the instrument with any sensor or other accessory that is not manufactured or licensed by Oridion or Covidien. The capnography component of this product is covered by one or more of the following US patents: 6,428,483; 6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent applications pending. Oridion®, Microstream®, FilterLine®, Smart CapnoLine®, CapnoLine®, Smart BiteBloc™, Smart CapnoLine Guardian™, NIV Line™, Capnostream®, 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 OXIMAXTM . Pulse Oximetry: U.S. Patents 5,485,847; 5,676,141; 5,743,263; 6,035,223; 6,226,539; 6,411,833; 6,463,310; 6,591,123; 6,708,049; 7,016,715; 7,039,538; 7,120,479; 7,120,480; 7,142,142; 7,162,288; 7,190,985; 7,194,293; 7,209,774; 7,400,919. Copyright © 2012 Oridion Medical 1987 Ltd., All rights reserved.

Safety Information

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.

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Contents Oridion Medical 1987 Ltd. ("Oridion Medical") - Warranty for Oridion Monitors3 Safety Information ... 11 Introduction ... 19 Overview ... 21 Initial Setup ... 29 Accessories ... 39 Basic Operation ... 47 Communication Interface... 67 Troubleshooting ... 69 Maintenance ... 79 Specifications ... 85

Portable Bedside Capnograph/Pulse Oximeter

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Table of Contents Oridion Medical 1987 Ltd. ("Oridion Medical") Warranty for Oridion Monitors ... 3 Safety Information ... 11 Warnings ... 11 General... 11 MRI Scanning ... 13 Alarms ... 13 Fire Hazard... 14 Electrical ... 14 Electro-magnetic Interference ... 15 Symbols ... 16

Introduction ... 19 Monitor Features ... 19

Overview ... 21 Principles of Operation ... 21 Capnography ... 21 Microstream EtCO2 Consumables ... 22 FilterLine ... 23 Pulse Oximetry ... 24 Displays, Controls and Connectors ... 26

Initial Setup ... 29 Power Requirements ... 29 Battery and Power Usage ... 30 Battery Pack ... 30 Unpacking and Inspection ... 32 Components ... 32 Optional Accessories ... 32 Start-Up and Self Test ... 33 Preparation ... 33 Use of Scavenging System ... 34 Initialization... 34 Portable Bedside Capnograph/Pulse Oximeter

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Single Parameter Setup Options ... 35 Measuring Mode ... 36 Terminating Operation of the Monitor ... 37 Battery Pack and AC Operation ... 37 Quick Guide ... 38

Accessories ... 39 Microstream EtCO2 Consumables ... 39 Microstream EtCO2 Consumables ... 39 Basic Principles ... 41 Nellcor™ SpO2 Sensors ... 41 Selecting Nellcor™ SpO2 Sensors ... 42 Performance Considerations ... 43

Basic Operation ... 47 Data Display Screens ... 47 CO2 Waveform ... 48 CO2 Time Base... 48 CO2 Trends... 49 Meter Mode ... 49 Plethysmograph Waveform Display ... 50 SpO2 Data Update Period ... 50 Pulse Bar Amplitude Indicator ... 50 SpO2 Trends ... 51 Graphic Display Screen Contrast ... 51 Displayed Data Options ... 52 Alarm Functions ... 53 Alarms ... 53 Factory Default Alarm Range Values ... 53 Alarm Limits Menu ... 54 Alarm Silence ... 55 Alarm Silence/Standby Menu ... 57 Instrument Settings Menus ... 58 Instrument Settings Menu Parameters... 58 CO2 Scale: Autoscale ... 59 User-defined Parameters Stored as Defaults ... 59 Changing Instrument Settings ... 60 6

Portable Bedside Capnograph/Pulse Oximeter

Institutional Settings ... 62 MRI Scanning ... 62 Standby ... 63 Pump Off Mode ... 64 Pump Off/On Label ... 65

Communication Interface ... 67 Troubleshooting ... 69 Alarms and Messages ... 69 Alarm and Message Priorities ... 69 Warnings ... 69 Cautions ... 70 Advisory Messages ... 72 Silent Advisories ... 73 Troubleshooting Guide ... 75

Maintenance ... 79 Periodic Maintenance ... 79 Service ... 80 Cleaning ... 80 Calibration ... 81 CO2 Calibration Check ... 81 Returning the Monitor ... 84 Technical Assistance ... 84

Specifications ... 85 Physical ... 85 Size ... 85 Weight ... 85 Noise Emission ... 85 Environmental ... 85 Temperature ... 85 Pressure and Altitude (for operating and storage) .. 86 Transport and Storage ... 86 Performance Standards ... 86 ™ OXIMAX Sensor Power Dissipation ... 87 Portable Bedside Capnograph/Pulse Oximeter

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Safety Standards ... 87 Environmental Standards ... 88 Compliance ... 88 ISO 9919:2005 Compliance ... 88 Manufacturer’s Declaration ... 89 Performance ... 89 Display Update Interval ... 90 Power Specifications ... 93 External Power Source... 93 Internal Power Source ... 93 Electrical ... 93 Instrument ... 93 ™ OXIMAX Sensors... 93 Electromagnetic Emissions ... 94 Electromagnetic Immunity ... 95 Recommended Separation Distances ... 99 Electric and Communication Cables ... 100 Sensors ... 101 Components and User Interface... 103 Displays ... 103 Controls and Indicators ... 103 Connections ... 103

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Portable Bedside Capnograph/Pulse Oximeter

List of Figures Figure 1: Monitor Front View ...26 Figure 2: Monitor Rear View ...28 Figure 3: Initialization Screen ...34 Figure 4: Self Test Screen...35 Figure 5: Quick Guide ...38 Figure 6: Monitor Display Screen and LEDs ...48 Figure 7: Pump Off ...64 Figure 8: Pump Off Additional Time ...65 Figure 9: Pump Off/On Label ...65

Portable Bedside Capnograph/Pulse Oximeter

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List of Tables Figure 1: Monitor Front View ... 26 Figure 2: Monitor Rear View ... 28 Figure 3: Initialization Screen ... 34 Figure 4: Self Test Screen ... 35 Table 1: Single Parameter Setup Options ... 35 Figure 5: Quick Guide ... 38 Table 2: Nellcor™ SpO2 Sensors... 43 Figure 6: Monitor Display Screen and LEDs ... 48 Table 3: Display Screens ... 52 Table 4: Factory Default Alarm Range Values ... 54 Table 5: Alarm Limits... 54 Table 6: Alarm Silence/Standby ... 57 Table 7: Instrument Settings Parameters (Menu 1) ... 58 Table 8: Instrument Settings Parameters (Menu 2) ... 59 Table 9: Changing Instrument Settings (Menu 1) ... 60 Table 10: Changing Instrument Settings (Menu 2) ... 61 Table 11: Institutional Settings ... 62 Table 12: Warning Messages ... 70 Table 13: Caution Messages ... 71 Table 14: Advisory Messages ... 72 Table 15: Silent Advisory Messages ... 73 Table 16: Troubleshooting Guide ... 75 Table 17: Accessing the Service Mode... 79 Table 18: CO2 Calibration Check ... 83

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Portable Bedside Capnograph/Pulse Oximeter

Safety Information Warnings Symbols

To use the portable capnograph/pulse oximeter monitor correctly and safely, carefully read this operator’s manual and the Directions for Use for the SpO2 sensors and Microstream EtCO2 consumables. 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, check the patient’s vital signs by alternate means, then make sure the monitor is functioning correctly.

WARNING:

To ensure patient safety, do not place the monitor and/or accessories 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.

Portable Bedside Capnograph/Pulse Oximeter

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Safety Information

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:

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

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:

This monitor is for use with one patient at a time 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. When the Blockage!! message appears on the screen, indicating that the FilterLine is blocked, the monitor’s CO2 pump will automatically shut off until the FilterLine is replaced with a new FilterLine. The patient's breath sample will not be pulled into the monitor while the pump is off.

Note:

Note:

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Follow the instructions that appear in the Troubleshooting section of this manual: First disconnect and reconnect the FilterLine. If the blockage message still appears, disconnect and replace the FilterLine. Once a new FilterLine is attached to the handheld monitor, the pump will automatically resume operation. When used in transport environment, use with the protective boot is required.

Portable Bedside Capnograph/Pulse Oximeter

Warnings

Note:

In high-altitude environments, etCO2 values may be lower than values observed at sea level, as described by Dalton's law of partial pressures. When using the monitor in high-altitude environments, it is advisable to consider adjusting etCO2 alarm settings accordingly.

MRI Scanning WARNING:

Do not use Nellcor™ 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 consumable 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 MRI Scanning, page 62.)

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 39.

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.

Portable Bedside Capnograph/Pulse Oximeter

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Safety Information

Fire Hazard WARNING:

When using the monitor with anesthetics, such as high concentrations of oxygen or nitrous oxide, 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.

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

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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:

Use only the medical grade AC adapter provided by the manufacturer. If in doubt about the integrity of the mains supply connection, operate the monitor from its internal battery pack.

WARNING:

Do not connect to a printer or to a PC unless using the Communication Adapter provided by the manufacturer as an optional accessory. The printer and PC (when connected to the patient through the Communication Adapter) must be distanced from the patient environment by at least 1.5 m.

WARNING:

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

Portable Bedside Capnograph/Pulse Oximeter

Warnings

CAUTION:

The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Considerations regarding the choice should include use of the accessory in the patient vicinity and evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 606011 and/or IEC60601-1-1 harmonized national standard.

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. These standards are 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 the 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 give incorrect measurements.

WARNING:

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

Portable Bedside Capnograph/Pulse Oximeter

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Safety Information

Symbols The following symbols appear on the monitor and monitor LCD (liquid crystal display): Symbol

Description See Directions for Use Gas Outlet

Defibrillator–proof Type BF equipment (patient electrically isolated)

Audible Alarms Off

Plug Icon

Battery Icon

EtCO2

End tidal carbon dioxide value

SpO2 %

Oxygen saturation value DC Input

Refer to manual for connector interface and other information Pump Off/On

Pump Off

Directive on waste electrical and electronic equipment

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Portable Bedside Capnograph/Pulse Oximeter

Symbols

Symbol

Description

CE mark

For prescription use only

Manufacturer Manufacture date

Portable Bedside Capnograph/Pulse Oximeter

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Introduction Monitor Features

This manual provides directions for setup and operation of the monitor. The monitor is a portable bedside capnograph/pulse oximeter that continuously monitors end tidal carbon dioxide (EtCO2), respiratory rate (RR), fractional inspired carbon dioxide (FiCO2), oxygen saturation (SpO2), and pulse rate. The unit is indicated for monitoring only and must be used in the continuous presence of a qualified healthcare provider. It is intended for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital, hospital-type facilities, transport and EMS. The monitor is intended for use on adult, pediatric, and infant/neonatal patients.

Monitor Features

• Combines a capnograph and pulse oximeter in a small, portable, lightweight monitor.

• Measures and displays EtCO2, FiCO2, respiration rate, SpO2, and pulse rate in one graphic and two digital displays.

• Displays CO2 and SpO2 waveforms and trends. • Utilizes a wide range of Microstream EtCO2 consumables and Nellcor™ SpO2 sensors for all applications.

• Operates on mains line power or a rechargeable Nickel Metal Hydride battery pack.

• Employs audible and visual alarm warnings for monitored parameters and instrument malfunctions.

• Provides user selectable language options: English, French, German, Spanish, Italian, Dutch, Swedish, Norwegian and Portuguese.

• Displays EtCO2 and FiCO2 values in mmHg, kPa or Vol%. • Provides output for printer, PC, and Digital to Analog Converter. • Provides interface to hospital nurse call systems.

Portable Bedside Capnograph/Pulse Oximeter

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Overview Principles of Operation FilterLine Pulse Oximetry Displays, Controls and Connectors

The monitor combines Oridion’s Microstream capnography technology with Covidien’s Nellcor™ pulse oximetry technology.

Principles of Operation Capnography The monitor 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) and during inhalation (FiCO2), and the Respiratory Rate. Infrared spectroscopy is used to measure the concentration of molecules that absorb infrared light. Because the absorption is proportional to the concentration of the absorbing molecule, the concentration can be determined by comparing its absorption to that of a known standard. The Microstream EtCO2 consumables deliver a sample of the inhaled and exhaled gases from the ventilator consumable or directly from the patient (via an oral/nasal cannula) into the monitor for CO2 measurement. Moisture and patient secretions are extracted from the sample, while maintaining the shape of the CO2 waveform. The 50 ml/min. sampling flow rate reduces liquid and secretion accumulation, decreasing the risk of obstruction in the sample pathway in humid ICU environments. Once inside the Microstream CO2 sensor, the gas sample goes through a micro-sample cell (15 microliters). This extremely small volume is quickly flushed, allowing for fast rise time and accurate CO2 readings, even at high respiration rates. The Micro Beam IR source illuminates the micro-sample cell and the reference cell. This proprietary IR light source generates only the specific wavelengths characteristic of the CO2 absorption spectrum. Therefore, no compensations are required when different concentrations of N2O, O2, anesthetic agents and water vapor are present in the inhaled Portable Bedside Capnograph/Pulse Oximeter

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Overview

and exhaled breath. The IR that passes through the micro-sample cell and the IR that passes through the reference cell are measured by the IR detectors. The microcomputer in the monitor calculates the CO2 concentration by comparing the signals from both channels. Microstream EtCO2 Consumables The following products comprise the Microstream EtCO2 consumables: Sample Lines and Airway Adapter Sets for Intubated Patients: • FilterLine Set (for non–humid environments).

• FilterLine H Set (for humid environments). • Vitaline H Set (for humid environments and high ambient humidity). Nasal and Oral/Nasal Cannulas for Non-intubated patients: • O2 CO2 Nasal FilterLine – nasal only sampling

• Smart CapnoLine and Smart CapnoLine Plus – oral/nasal sampling for use in procedural sedation. Also available with O2 delivery.

• CapnoLine H – for patients receiving hi–flow oxygen by mask, on long term CPAP or Bi-PAP, or post-op pain management. Also available with O2 delivery. Note: Note:

Smart products provide oral and nasal sampling. H products are for long term use. The generic term FilterLine, used in this manual, is interchangeable with any of the Microstream EtCO2 consumables.

A list of available part numbers appears in Microstream EtCO2 Consumables on page 39.

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Portable Bedside Capnograph/Pulse Oximeter