NPB-70 Handheld Capnograph Operators Manual Rev A Aug 1999

Mallinckrodt Inc. 675 McDonnell Boulevard PO. Box 5840 St. Louis, MO 63134 Tel 314.654.2000 Toll Free 1.800.635.5267 Mallinckrodt Europe BV Hambakenwetering 1 5231 DD ‘s-Hertogenbosch The Netherlands Tel. +31.73.6485200 Nellcor Puritan Bennett 4280 Hacienda Drive Pleasanton, CA 94588

Nellcor Puritan Bennett Inc. is a wholly owned subsidiary of Mallinckrodt, Inc. Nellcor and Nellcor Puritan Bennett are trademarks of Mallinckrodt Inc. To obtain information about a warranty, if any, for this product, contact Mallinckrodt Technical Services or your local Mallinckrodt representative. Microstream and FilterLine are trademarks of Oridion Medical Ltd. Capnography covered by one or more of the following U.S. Patents and foreign equivalents: 4,755,675; 5,063,275; 5,300,859, 5,657,750.

OPERATOR’S MANUAL

Handheld Capnograph

Notice: Purchase of this instrument confers no express or implied license under any Oridion Medical patent to use the instrument with any accessory that is not manufactured or licensed by Oridion Medical Ltd. The following are trademarks of Oridion Medical Ltd.: Microstream and FilterLine. Capnography covered by one or more of the following U.S. patents and foreign equivalents: 4,755,675; 5,063,275; 5,300,859, 5,657,750.

CI04561D

TABLE OF CONTENTS Contents List of Figures List of Tables

CONTENTS SAFETY INFORMATION... 1 WARNINGS ...1 General ...1 MRI Scanning ...2 Alarms...2 Fire Hazard ...3 Electrical ...3 Electro Magnetic Interference...4 SYMBOLS...4

INTRODUCTION ... 7 MONITOR FEATURES ...7

OVERVIEW ... 9 PRINCIPLES OF OPERATION ...9 Microstream EtCO2 Circuits ...10 DISPLAYS, CONTROLS, AND CONNECTORS ...12

INITIAL SETUP ... 15 POWER REQUIREMENTS ...15 Battery and Power Usage ...16 Battery Pack...16 UNPACKING AND INSPECTION ...18 Components ...18 Optional Accessories ...19 START-UP AND SELF-TEST ...20 Preparation ...20 Initialization ...21 MEASURING MODE...22 HANDHELD CAPNOGRAPH QUICK GUIDE...23

CIRCUITS... 25 MICROSTREAM EtCO2 CIRCUITS ...25 Basic Principles...25

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Table of Contents

BASIC OPERATION...27 DATA DISPLAY SCREENS...27 CO2 Waveform ...28 CO2 Trends ...28 Meter Mode...29 Graphic Display Screen Contrast...29 DISPLAYED DATA OPTIONS ...30 ALARM FUNCTIONS...31 Alarms...31 ALARM LIMITS MENU ...33 Alarm Silence...34 ALARM SILENCE/STANDBY MENU...35 INSTRUMENT SETTINGS MENU...36 Instrument Settings Menu Parameters ...36 User-defined Parameters...37 Changing Instrument Settings ...38 Institutional Settings...39 STANDBY ...39

COMMUNICATION INTERFACE...41 COMMUNICATION ADAPTER...41 COMMUNICATION OPTIONS TO A PRINTER AND PC...42 Screen...42 Tabular Trend (5s)/(1m) ...43 Graphic Trend ...44 Trend History ...45 Tabular Trend (14 Hr) ...47 Monitor Setup for Printer/PC Communication...48 COMMUNICATION INTERFACE TO A PRINTER ...49 Printer Setup ...49 PRINTING ...52 COMMUNICATION INTERFACE TO A PC ...53 Transferring the Data to the PC...53 Downloading the Data...53 TROUBLESHOOTING...54 ADDITIONAL INFORMATION ...55 Ordering the Seiko DPU-414 Printer ...55 Technical Support for the Monitor...55 Technical Support for the Seiko Printer ...55

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Table of Contents

TROUBLESHOOTING... 57 ALARMS AND MESSAGES...57 Alarm and Message Priorities...57 Warnings...57 Cautions...59 Advisory Messages...60 Silent Advisories ...61 TROUBLESHOOTING GUIDE ...63

MAINTENANCE ... 65 PERIODIC MAINTENANCE ...65 SERVICE ...66 CLEANING...66 CO2 CALIBRATION CHECK...66 RETURNING THE MONITOR ...69 TECHNICAL ASSISTANCE...69

SPECIFICATIONS... 71 PHYSICAL ...71 Size ...71 Weight (including battery pack) ...71 Noise Emission ...71 ENVIRONMENTAL ...71 Temperature ...71 Relative Humidity ...71 Pressure and Altitude (for operating and storage)...71 SAFETY STANDARDS ...72 PERFORMANCE ...72 POWER SPECIFICATIONS ...73 External Power Source ...73 Internal Power Source ...73 COMPONENTS AND USER INTERFACE ...73 Displays ...73 Controls and Indicators ...74 Connections ...74

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Table of Contents

List of Figures Figure 1: Monitor Front and Side View... 12 Figure 2: Monitor Rear View... 13 Figure 3: Initialization Screen ... 21 Figure 4: Quick Guide Adhesive Label... 23 Figure 5: Monitor Display Screen and LEDs... 27 Figure 6: Tabular Trend Printout ... 43 Figure 7: Graphic Trend Printout... 44 Figure 8: Trend History Printout ... 46

List of Tables Table 1: Packaged monitor ... 18 Table 2: Display Screens... 30 Table 3: Factory Default Alarm Range Values ... 32 Table 4: Alarm Limits... 33 Table 5: Alarm Silence/Standby ... 35 Table 6: Instrument Settings Menu Parameters ... 36 Table 7: Changing Instrument Settings... 38 Table 8: Institutional Settings ... 39 Table 9: Print Options... 42 Table 10: Monitor Setup ... 48 Table 11: Dip Switch Settings ... 50 Table 12: Start/Stop Printing Options... 52 Table 13: COM Property Settings ... 53 Table 14: Troubleshooting Examples ... 54 Table 15: Warning Messages ... 58 Table 16: Caution Messages... 59 Table 17: Advisory Messages ... 60 Table 18: Silent Advisory Messages ... 61 Table 19: Troubleshooting Guide... 63 Table 20: Accessing the Service Mode... 65 Table 21: CO2 Calibration Check ... 67

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SAFETY INFORMATION Warnings Symbols To use the monitor correctly and safely, carefully read this operator’s manual and the Directions for Use for the Microstream EtCO2 circuits. Use of the monitor requires full understanding and strict observation of these instructions, precautionary information in boldface type, and 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 in any position that might cause it to fall on the patient.

WARNING: Carefully route patient cabling (FilterLine) to reduce the possibility of patient entanglement or strangulation.

WARNING: Do not lift the monitor by the FilterLine as it could disconnect from the monitor, causing the monitor to fall on the patient.

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

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Safety Information

WARNING: CO2 readings and respiratory rate readings can be affected by certain ambient environmental conditions and certain patient conditions. Caution: The monitor is a prescription device and to be operated by qualified healthcare personnel only. Caution: Connect the gas outlet to a scavenging system when using the monitor with N2O or other anesthetic agents. MRI Scanning WARNING: Do not use the monitor during magnetic resonance imaging (MRI) scanning.

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.

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Safety Information

WARNING: The monitor is not to be used as an apnea monitor. (An apnea message appears if a valid breath has not been detected for 15 seconds [neonatal mode] or 30 seconds [adult mode]. This indicates the time elapsed since the last valid breath and is not a diagnosis.) Fire Hazard WARNING: When using the monitor with flammable gases or anesthetics, such as high concentrations of oxygen or nitrous oxide, connect the gas outlet to a scavenger system. Electrical WARNING: 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.

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Safety Information

Electro Magnetic Interference WARNING: This device has been tested and found to comply with the requirements for medical devices according to the standard EN60601-1/1990, A1/1993, A2/1995. 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. SYMBOLS The following symbols appear on the monitor and accessories: See Instructions for Use Gas Outlet Defibrillator-proof typeType BF equipment (patient electrically isolated) Audio Alarms Off

Plug Icon Battery Icon Breaths per minute End tidal carbon dioxide value 4

Safety Information

The following symbols appear on the Communication Adapter: Serial communications port

DC output

DC input

Printer interface

PC interface

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INTRODUCTION Monitor Features This manual provides directions for setup and operation of the handheld capnograph monitor. The device is a handheld capnograph that continuously monitors end tidal carbon dioxide (EtCO2) and respiratory rate. The monitor is for attended 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 and mobile use (when protected from excessive moisture such as direct rainfall). The monitor is intended for use on adult, pediatric, and infant/neonatal patients. MONITOR FEATURES • Capnograph in a small, handheld, lightweight monitor. • Measures and displays EtCO2, and respiration rate, in one graphic and two digital displays. • Displays CO2 waveforms and trends. • Utilizes a wide range of Microstream EtCO2 circuits and adapters for all applications. • Operates on main 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. • Displays EtCO2 values in mmHg, kPa or Vol%. • Provides output for printer or PC. 7

OVERVIEW Principles of Operation Displays, Controls, and Connectors

The monitor incorporates Oridion’s Microstream capnography technology. PRINCIPLES OF OPERATION The monitor uses Microstream non-dispersive infrared (IR) spectroscopy to continuously measure the amount of CO2 during every breath, the amounts 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 circuits deliver a sample of the inhaled and exhaled gases from the ventilator circuit or directly from the patient 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. low sampling flow rate reduces liquid and secretion accumulation, thus the sample flow is not obstructed, even in humid ICU environments. Once inside the Microstream CO2 sensor, the gas sample goes through a microsample 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 Microbeam IR source illuminates the microsample cell and the reference channel. This proprietary IR light source generates only the specific wavelengths characteristic of the CO2 absorption spectrum. Therefore, no compensations are required when different 9

Overview

concentrations of N2O, O2, anesthetic agents, and water vapor are present in the inhaled and exhaled breath. The radiation that passes through the microsample cell and the radiation that passes through the reference channel are measured by the IR detectors. The microcomputer in the monitor calculates the CO2 concentration by comparing the signals from both channels. Microstream EtCO2 Circuits - Microstream FilterLine The Microstream FilterLine has four active elements that work together to offer a solution to the problems that have previously posed challenges to capnography in ICU, emergency, and transport applications. These elements are described below. * Hydrophobic filter

The hydrophobic filter is located at the end of the sample line that is closest to the capnograph. This filter strips the remaining water vapor from the gas sample while keeping a laminar flow of the gas. This laminar flow minimizes distortion of the CO2 waveform. This filter is made of 0.45µ hydrophobic porous media that reduces biological contaminants. * Drying element

The drying element is a tube made of a synthetic material that is chemically stable and has high water absorption. This material allows the water vapor to pass outside the tube, thereby adjusting the humidity inside the FilterLine close to the level of humidity in the ambient air.

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Overview

* Sample line

The sample line has low dead space due to its small internal diameter. This provides a sharp waveform and an accurate CO2 reading at high breath rate per minute. The sample line is not affected by gases and anesthetic agents in the operating room environment. * FilterLine Recognition Safeguard

When the FilterLine is attached to the monitor, the FilterLine Recognition Safeguard (FRS) identifies the FilterLine and activates the monitor, thus enabling it to take a measurement. - Microstream Airway Adapter The Microstream airway adapter design provides multiple channels for the sampled air from the airway minimizing the possibility of water infiltration or line blockage. These multiple channels allow uninterrupted monitoring for all adapter orientations and in all applications. The Microstream airway adapter provides optimal performance in all directions and is seldom disabled by secretions or liquids.

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Overview

DISPLAYS, CONTROLS, AND CONNECTORS

Figure 1: Monitor Front and Side View

The numbered labels in Figure 1 are described below. 1. ON/OFF Switch 2. Alarm Bar 3. Digital Display of EtCO2 and Respiration Rate 4. Graphic Display 5. Contrast/Changes Value Button *6. Next/Menu Button 7. Battery Pack *6+8 = Data Transfer ON/OFF 12

*8. Event/Home Button 9. Power Supply/ Communication Adapter Port 10. Alarm Silence/Alarm Silence Menu Button 11. Alarm Silence Indicator 12. Gas Outlet 13. Photo Resistor 14. FilterLine Input Connector

Overview

1

2

3

4 5 Figure 2: Monitor Rear View

The numbered labels in Figure 2 are described below. 1. Clamp Adapter 2. Space for Quick Guide Adhesive Label

3. Serial Number Label 4. Battery Pack Release Button 5. Battery Pack

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INITIAL SETUP Power Requirements Unpacking & Inspection Start-up and Self-Test Measuring Mode Handheld Capnograph Quick Guide

POWER REQUIREMENTS The monitor operates on batteries or on AC power. It is equipped with a rechargeable Nickel Metal Hydride battery pack. When a power outlet is available, use the medical grade AC adapter provided with the monitor. Before using the monitor in the field, ensure that the battery pack is fully charged. (At the measuring mode, check that the battery icon at the right side of the graphic display is full.) Note: If the battery is not fully charged, the icon may first show as full and after a short period of time will drop to indicate the real charge level. A fully charged battery pack provides between three to six operating hours, depending on power management (refer to Table 6 for a description of the power management options). 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: To ensure patient electrical isolation, connect only to other equipment with circuits that are electrically isolated.

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