Portable Bedside Capnograph Operators Manual Rev A

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 1987 Ltd. Capnography is covered by one or more of the following United States patents: 6,437,316; 5,300,859; 6,428,483; 6,997,880 and their foreign equivalents. Additional patent applications pending. Oridion®, Microstream®, FilterLine®, Smart CapnoLine®, CapnoLine®, Smart BiteBloc™, NIV Line™, Capnostream™, Microcap®, Microcap® Plus, and VitalCap® are trademarks or registered trademarks of Oridion Medical 1987 Ltd. Exemptions Oridion'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. All information in this manual is believed to be correct. Oridion shall not be liable for errors contained herein with the performance or use of this manual.

Copyright © 2006 Oridion Medical 1987 Ltd., All rights reserved.

Table of Contents CHAPTER 1 SAFETY INFORMATION ... 7 Warnings ... 7 Symbols ... 10

CHAPTER 2 INTRODUCTION... 11 Monitor Features ... 11

CHAPTER 3 OVERVIEW ... 13 Principles of Operation... 13

CHAPTER 4 INITIAL SETUP... 19 Power Requirements ... 19 Unpacking and Inspection... 22 Start-up and Self test ... 23 Measuring Mode ... 25 Quick Guide ... 26

CHAPTER 5 CONSUMABLES ... 27 MICROSTREAM EtCO2 Consumables ... 27

CHAPTER 6 BASIC OPERATION... 29 Data Display Screens ... 29 Displayed Data Options ... 32 Alarm Functions ... 33 Alarm Limits Menu ... 35 Alarm Silence/Standby Menu... 37 Instrument Settings Menus ... 38

CHAPTER 7 COMMUNICATION INTERFACE ... 47 Communication Interface ... 47

CHAPTER 8 TROUBLESHOOTING... 49 Alarms and Messages ... 49 Troubleshooting Guide... 54

CHAPTER 9 MAINTENANCE... 57 Periodic Maintenance ... 57 Service ... 58 Portable Bedside Capnograph

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Cleaning ... 58 Calibration ... 59 CO2 Calibration Check... 59 Returning the Monitor... 61 Technical assistance ... 62

CHAPTER 10 SPECIFICATIONS...63 Physical ... 63 Environmental ... 63 Safety Standards... 64 Compliance ... 64 Manufacturer’s Declaration ... 67 Performance... 67 Power Specifications ... 68 Electrical ... 69 Components and User Interface ... 75

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List of Figures Figure 1: Monitor Front and Side View... 17 Figure 2: Monitor Rear View ... 18 Figure 3: Initialization Screen... 24 Figure 4: Quick Guide ... 26 Figure 5: Monitor Display Screen and LEDs ... 30 Figure 6: Pump Off... 45 Figure 7: Pump Off Additional Time ... 46 Figure 8: Pump Off/On Label ... 46

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List of Tables Table 1: Symbols on the Device ... 10 Table 2: Display Screens... 32 Table 3: Factory Default Alarm Range Values... 35 Table 4: Alarm Limits ... 35 Table 5: Alarm Silence/Standby ... 37 Table 6: Instrument Settings Parameters (Menu 1) ... 38 Table 7: Instrument Settings Parameters (Menu 2) ... 40 Table 8: Changing Instrument Settings (Menu 1) ... 41 Table 9: Changing Instrument Settings (Menu 2) ... 42 Table 10: Institutional Settings... 43 Table 11: Warning Messages ... 50 Table 12: Caution Messages ... 51 Table 13: Advisory Messages... 52 Table 14: Silent Advisory Messages... 53 Table 15: Troubleshooting Guide ... 55 Table 16: Accessing the Service Mode... 58 Table 17: CO2 Calibration Check ... 60

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Portable Bedside Capnograph

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Chapter 1

Safety Information Warnings Symbols

To use the portable capnograph correctly and safely, carefully read this operator’s manual and the Directions for Use for the 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, and 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.

WARNING:

CO2 readings and respiratory rate readings can be affected by certain ambient environmental conditions and certain patient conditions.

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Safety Information

WARNING:

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

MRI Scanning WARNING:

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 on page 44.)

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.

Fire Hazard 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.

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.

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Warnings

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:

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.

Electro-magnetic Interference This device has been tested and found to comply with the requirements for medical devices according to the standard EN606011-2/2001. 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, or 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.

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Safety Information

Symbols The following symbols appear on the monitor and monitor LCD (liquid crystal display): Table 1: Symbols on the Device Symbol

Description

See Directions for Use Gas Outlet Defibrillator-proof Type BF equipment (patient electrically isolated) Audio Alarms Off Plug Icon Battery Icon Respiratory Rate (breaths per minute) EtCO2

End tidal carbon dioxide value DC Input Refer to manual for connector interface and other information

Pump Off/On

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Pump Off

Portable Bedside Capnograph

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Chapter 2

Introduction Monitor Features

This manual provides directions for setup and operation of the portable capnograph monitor. The device is a portable capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The monitor is 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 hospital type facilities. The monitor is intended for use on adult, pediatric, and infant/neonatal patients.

Monitor Features •

Capnograph in a small, portable, lightweight monitor

•

Measures and displays EtCO2, FiCO2, and respiration rate, in one graphic and two digital displays

•

Displays CO2waveforms and trends

•

Utilizes a wide range of Microstream EtCO2 consumables 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

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Introduction

12

•

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.

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Chapter 3

Overview Principles of Operation FilterLine Displays, Controls, and Connectors

The monitor incorporates Oridion’s Microstream capnography technology.

Principles of Operation 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 circuit 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 microsample cell (15 microliters). This extremely small volume is

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Overview

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 concentrations of N2O, O2, anesthetic agents, and water vapor are present in the inhaled and exhaled breath. The IR that passes through the microsample cell and the IR 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 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). Nasal and Oral/Nasal Cannulas for Non-intubated patients: • Smart CapnoLine Plus – 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. • NIV Line – for use under oxygen, CPAP, Bi–PAP or NPPV mask. *

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Smart products provide oral and nasal sampling. H products are for long term use.

Portable Bedside Capnograph

FilterLine

Special Procedure FilterLines • FilterLine XL – Provides extended length so that the monitor can be used safely during MRI (see MRI Scanning on page 44). Note:

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

FilterLine The FilterLine has five active elements that work together to offer a solution to the problems that have previously posed challenges to capnography in ICU, emergency, and intra-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 a 0.2 μ hydrophobic porous medium. *

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. *

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.

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Overview

*

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 measuring. *

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.

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Displays, Controls, and Connectors

Displays, Controls, and Connectors

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Figure 1: Monitor Front and Side View

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

On/Off Switch

2.

Alarm Bar

3.

Digital Display of EtCO2 and Respiration Rate

4.

Graphic Display

5.

Contrast/Value Change Button

9.

Port for AC Adapter or communication adapters

10. Alarm Silence/Alarm Silence Menu Button 11. Alarm Silence Indicator 12. Gas Outlet 13. Photo Resistor

6.

Next/Menu Button

14. FilterLine Input Connector

7.

Battery Pack

8.

Event/Home Button

15. Pump Off/On Adhesive Label

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Overview

1

2

3

4 5 Figure 2: Monitor Rear View

The numbered labels in Figure 2: Monitor Rear View are described below.

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1.

Clamp Connector

3.

Serial Number Label

2.

Space for Quick Guide Adhesive Label

4.

Battery Pack Release Button

5.

Battery Pack

Portable Bedside Capnograph

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Chapter 4

Initial Setup Power Requirements Unpacking and Inspection Start-up and Self test 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 and seven operating hours, depending on power management (refer to Table 6: Instrument Settings Parameters (Menu 1) on page 38 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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Initial Setup

Battery and Power Usage If power is lost when the monitor is operating from AC power, it automatically switches to its internal battery pack for power. A plug-shaped icon at the bottom right side of the graphic display is displayed when the monitor operates from an external power source and the battery pack is fully charged. A battery-shaped icon is displayed when the monitor operates from the battery pack. The battery icon will show the battery pack’s approximate charge level. An advisory message, Battery !, appears when approximately 40 minutes of battery charge remains. A caution message, Battery !!, appears when approximately 15 minutes of charge time remains. While the monitor is connected to AC power, the battery pack can be replaced without interrupting monitoring. Battery Pack Before using a new battery pack for the first time, charge and discharge the battery three times to ensure full battery capacity. For charging and discharging, the Microstream Capnograph Battery Charger is recommended (refer to the Microstream Capnograph Battery Charger Directions for Use). Internal Recharge Function CAUTION:

Do not attempt to disassemble the battery pack. It is a sealed unit and has no serviceable parts inside.

When the monitor is connected to an external power source (even if the monitor is turned off), the battery pack charges automatically. If the instrument is on during charging, the battery-shaped icon displays a filling pattern. It takes approximately 4.5 hours to fully charge an empty battery pack. Additional battery packs can be purchased from your local representative. The recommended temperature for battery charging is between 5ºC and 45ºC.

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