OxiMax NPB-75 Portable Capnograph Pulse Oximeter Operators Manual Rev A June 2005

Notice: Purchase of this instrument confers no express or implied license under any Oridion Medical patent or Nellcor Puritan Bennett patent to use the instrument with any accessory that is not manufactured or licensed by Oridion Medical 1987 Ltd.

Nellcor Puritan Bennett Incorporated is an affiliate of Tyco Healthcare.The following are registered trademarks of Oridion Medical 1987 Ltd.: Microstream and FilterLine. The following are trademarks of Nellcor Puritan Bennett Incorporated: Oxiband; Durasensor; OxiCliq; Dura-Y; and OXIMAX®. This product is covered by one or more of the following United States patents: 6,491,643; 6,656,127; 6,168,958; 5,300,859 and 4,755,675 and their foreign equivalents. この製品は、次の日本における特許、1980816と海外での同等のものによっ て保護されて居ります。

Pulse Oximetry covered by one or more of the following U.S. Patents and foreign equivalents: Re.35,122; 4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136; 5,351,685; 5,368;026; 5,485,847; 5,533,507; 5,662,106; 5,853,364; 5,865,736; 6,083,172; and 5,803,910.

010191A – 6/05

TABLE OF CONTENTS Contents List of Figures List of Tables

SAFETY INFORMATION... 1 WARNINGS ... 1 General ... 1 MRI Scanning... 2 Alarms ... 2 Fire Hazard ... 3 Electrical... 3 Electro Magnetic Interference ... 4 SYMBOLS ... 5

INTRODUCTION ... 7 MONITOR FEATURES... 7

OVERVIEW ... 9 PRINCIPLES OF OPERATION ... 9 Capnography... 9 Microstream EtCO2 Consumables ... 10 Pulse Oximetry... 12 DISPLAYS, CONTROLS AND CONNECTORS ... 14

INITIAL SETUP ... 17 POWER REQUIREMENTS ... 17 Battery and Power Usage ... 18 Battery Pack... 18 Unpacking and Inspection... 20 Components... 20 Optional Accessories ... 20 START–UP AND SELF TEST... 21 Preparation... 22 Initialization ... 22 SINGLE PARAMETER SETUP OPTIONS ... 23 MEASURING MODE ... 24 Battery Pack and AC Operation... 25 QUICK GUIDE ... 26

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Table of Contents

ACCESSORIES ... 27 MICROSTREAM EtCO2 CONSUMABLES ... 27 Basic Principles ... 27 NELLCOR SpO2 SENSORS ... 28 Selecting Nellcor SpO2 Sensors... 29 Performance Considerations... 30

BASIC OPERATION... 33 DATA DISPLAY SCREENS ... 33 CO2 Waveform ... 34 CO2 Trends... 35 Meter Mode ... 36 Plethysmograph ... 36 SpO2 Trends... 36 Graphic Display Screen Contrast... 36 DISPLAYED DATA OPTIONS ... 37 ALARM FUNCTIONS ... 38 Alarms 38 Factory Default Alarm Range Values... 39 ALARM LIMITS MENU... 40 Alarm Silence ... 41 ALARM SILENCE/STANDBY MENU... 42 INSTRUMENT SETTINGS MENUS ... 43 Instrument Settings Menu Parameters... 43 CO2 Scale: Autoscale... 44 User-defined Parameters Stored as Defaults .. 44 Changing Instrument Settings... 45 Institutional Settings ... 47 MRI SCANNING ... 48 STANDBY ... 49 PUMP OFF MODE... 49 PUMP OFF/ON LABEL ... 51

COMMUNICATION INTERFACE ... 53 COMMUNICATION ADAPTER ... 54

TROUBLESHOOTING... 55 ALARMS AND MESSAGES... 55 Alarm and Message Priorities ... 55 Warnings ... 55 Cautions ... 57 Advisory Messages ... 58 Silent Advisories... 59 iv

Table of Contents

TROUBLESHOOTING GUIDE ... 61

MAINTENANCE ... 63 PERIODIC MAINTENANCE ... 63 SERVICE ... 64 CLEANING ... 64 CALIBRATION ... 64 RETURNING THE MONITOR ... 67 TECHNICAL ASSISTANCE ... 67

SPECIFICATIONS... 69 PHYSICAL ... 69 Size ... 69 Weight ... 69 Noise Emission ... 69 ENVIRONMENTAL... 69 Temperature... 69 Pressure and Altitude... (for operating and storage) ... 70 Transport and storage... 70 OXIMAX® Sensor Power Dissipation... 70 SAFETY STANDARDS ... 71 COMPLIANCE ... 71 MANUFACTURER’S DECLARATION... 74 PERFORMANCE... 74 Capnograph ... 74 Display Update Interval ... 75 PULSE OXIMETER ... 75 External Power Source ... 78 Internal Power Source... 78 ELECTRICAL ... 78 Instrument ... 78 OXIMAX® Sensors ... 78 Electromagnetic Emissions ... 79 Electromagnetic Immunity... 80 Electromagnetic Immunity... 82 Recommended Separation Distances ... 84 Cables ... 85 COMPONENTS AND USER INTERFACE... 88 Displays... 88 Controls and Indicators ... 88 Connections ... 88

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Table of Contents

LIST OF FIGURES Figure 1: Monitor Front View... 14 Figure 2: Monitor Rear View ... 15 Figure 3: Initialization Screen... 22 Figure 4: Self Test Screen ... 23 Figure 5: Quick Guide ... 26 Figure 6: Monitor Display Screen and LEDs ... 34 Figure 7: Pump Off... 50 Figure 8: Pump Off Additional Time ... 50 Figure 9: Pump Off/On Label ... 51 LIST OF TABLES Table 1: Single Parameter Setup Options... 24 Table 2: Nellcor SpO2 Sensors ... 29 Table 3: Display Screens ... 37 Table 4: Factory Default Alarm Range Values ... 39 Table 5: Alarm Limits ... 40 Table 6: Alarm Silence/Standby... 42 Table 7: Instrument Settings Parameters (Menu 1)... 43 Table 8: Instrument Settings Parameters (Menu 2)... 44 Table 9: Changing Instrument Settings (Menu 1)... 45 Table 10: Changing Instrument Settings (Menu 2)... 46 Table 11: Institutional Settings ... 47 Table 12: Warning Messages ... 56 Table 13: Caution Messages ... 57 Table 14: Advisory Messages ... 58 Table 15: Silent Advisory Messages ... 59 Table 16: Troubleshooting Guide... 61 Table 17: Accessing the Service Mode ... 63 Table 18: CO2 Calibration Check ... 66

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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 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 (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: 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: 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. Caution: The monitor is a prescription device and is to be operated by qualified healthcare personnel only. 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. 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 48.) 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.

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Safety Information

WARNING: Check the audible alarm silence duration before temporarily silencing the audible alarms. Caution: Before each use, make sure that the monitor default alarm settings are appropriate for the specific patient being monitored. 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. Electrical WARNING: Electric shock hazard. The monitor’s cover is to be removed only by qualified service personnel. There are no userserviceable 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 EN60601-1-2/2001. 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.

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Safety Information

SYMBOLS The following symbols appear on the monitor and monitor LCD (liquid crystal display): See Instructions 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

Connector Interface

Pump Off/On

Pump Off

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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 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 • 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.

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OVERVIEW Principles of Operation Displays, Controls and Connectors The monitor combines Oridion’s Microstream capnography technology with 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. 9

Overview

Therefore, no compensations are required when different concentrations of N2O, O2, anesthetic agents and water vapor are present in the inhaled 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: Intubated • FilterLine Set (for non–humid environments

• FilterLine H set (for humid environments). Non-intubated • Smart CapnoLine Oral Nasal Cannula – for use in procedural sedation. Also available with O2 delivery.

• CapnoLine H – for use in ICU for patients receiving hi–flow oxygen by mask or on long term CPAP or Bi-PAP. Also available with O2 delivery.

• NIV–Line – for use under oxygen CPAP, Bi–PAP or NPPV mask and to avoid intubation during EMS transport.

Special Procedure FilterLines • FilterLine XL– Provides extended length so that the monitor can be used safely during MRI (see, page 48). Note:

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The generic term FilterLine, used in this manual, is interchangeable with any of the Microstream EtCO2 consumables.

Overview

FilterLine The FilterLine has five active elements that work together to offer a solution to the problems that have previously proved challenging 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. *

Drying element

The drying element is a tube made of a synthetic material that is extremely 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. *

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 a 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 pump, thus enabling measuring.

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Overview

*

Airway Adapter

The 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 airway adapter provides optimal performance in all directions and is seldom disabled by secretions or liquids. Pulse Oximetry Operating Principles Pulse oximetry is based on two principles: oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry), and the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (plethysmography). A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measures changes in light absorption during the pulsatile cycle. Red and infrared low–power light–emitting diodes (LEDs) in the oximetry sensor serve as light sources; a photodiode serves as the photodetector. Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation. To identify the oxygen saturation of arterial hemoglobin, the monitor uses the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase. During diastole, blood volume and light absorption reach their lowest point. The monitor bases its SpO2 measurements on the difference between maximum and minimum absorption (measurements at systole and diastole). The focus of light absorption by pulsatile arterial blood eliminates the effects of nonpulsatile absorbers such as tissue, bone, and venous blood.

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Overview

Automatic Calibration Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies, an oximeter must know the mean wavelength of the sensor's red LED to accurately measure SpO2. During monitoring, the instrument's software selects coefficients that are appropriate for the wavelength of that individual sensor's red LED; these coefficients are then used to determine SpO2. Additionally, to compensate for differences in tissue thickness, the light intensity of the sensor's LEDs is adjusted automatically. Functional versus Fractional Saturation This monitor measures functional saturation–oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin. In contrast, laboratory hemoximeters report fractional saturation–oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobins. To compare functional saturation measurements to those from an instrument that measures fractional saturation, fractional measurements must be converted as follows: functionalsaturation =

fractionalsaturation 100 - (% carboxyhemoglobin + % methemoglobin)

× 100

Measured versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen (PO2), the calculated value may differ from the SpO2 measurement of a pulse oximeter. This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO2 and saturation: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3DPG, and fetal hemoglobin.

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Overview

DISPLAYS, CONTROLS AND CONNECTORS

Figure 1: Monitor Front View The numbered labels in Figure 1 are described below. 1

SpO2 Connector

9

Battery Pack

2

Off/On Switch

10

FilterLine Input Connector

3

Alarm Bar

11

Gas Outlet

4

Digital Display of SpO2

12

Digital Display of EtCO2

5

Graphic Display

13

Photo Resistor

6

Contrast/Value Change Button

14

Alarm Silence Indicator

7

Alarm Silence/ Alarm Silence Menu Button

15

Port for AC Adapter or communication adapters

8

Next/Menu Button

16

Event /Home Button

17

Pump Off/On Adhesive Label

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Overview

1 7 2

3

4

5

6

Figure 2: Monitor Rear View

The numbered labels in Figure 2 are described below. 1. FilterLine Input Connector

5.Battery Pack Release Button

2.Clamp Connector

6. Battery Pack

3. Space for Quick Guide Adhesive Label

7. SpO2 Connector Latch

4. Serial Number label

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INITIAL SETUP Power Requirements Unpacking and Inspection Start–up and Self Test Single Parameter Setup Options Measuring Mode 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 four to seven operating hours, depending on power management (refer to Table 7 for a description of the power management options). WARNING: Use only the medical grade AC adapter provided by the manufacturer. If unsure about the integrity of the line 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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