Microcap Portable Capnography Monitor Operators Manual Dec 2006

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. THE FOLLOWING ARE REGISTERED TRADEMARKS OF ORIDION MEDICAL 1987 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.

009544B-12/06

TABLE OF CONTENTS Contents List of Figures List of Tables

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

INTRODUCTION ... 5 MONITOR FEATURES ... 5

OVERVIEW ... 7 PRINCIPLES OF OPERATION ... 7 Microstream EtCO2 Consumables ... 8 DISPLAYS, CONTROLS AND CONNECTORS ... 10

INITIAL SETUP ... 13 POWER REQUIREMENTS ... 13 Battery and Power Usage ... 13 Battery Pack... 14 UNPACKING AND INSPECTION ... 16 Components ... 16 Optional Accessories ... 16 START-UP AND SELF TEST... 17 Preparation... 17 Initialization ... 18 MEASURING MODE ... 19 Battery Pack and AC Operation... 20 QUICK GUIDE ... 20

CONSUMABLES... 21 iii

TABLE OF CONTENTS

MICROSTREAM EtCO2 CONSUMABLES ... 21 Basic Principles ... 21

BASIC OPERATION...23 DATA DISPLAY SCREENS ... 23 CO2 Waveform ... 24 CO2 Trends... 25 Meter Mode ... 26 Graphic Display Screen Contrast... 26 DISPLAYED DATA OPTIONS ... 27 ALARM FUNCTIONS ... 28 Alarms ... 28 ALARM LIMITS MENU... 30 Alarm Silence ... 31 ALARM SILENCE/STANDBY MENU... 32 INSTRUMENT SETTINGS MENUS... 33 Instrument Settings Menu Parameters... 33 User-defined Parameters ... 35 Changing Instrument Settings... 35 Institutional Settings ... 38 MRI SCANNING... 38 STANDBY ... 39 PUMP OFF MODE... 40 PUMP OFF/ON LABEL ... 41

COMMUNICATION INTERFACE ...43 COMMUNICATION ADAPTER ... 44

TROUBLESHOOTING ...45 ALARMS AND MESSAGES... 45 Alarm and Message Priorities ... 45 Warnings ... 46 Cautions ... 47 Advisory Messages ... 48 Silent Advisories... 49 TROUBLESHOOTING GUIDE ... 51

MAINTENANCE...53 PERIODIC MAINTENANCE ... 53 SERVICE... 54 CLEANING... 54 CALIBRATION... 54 iv

TABLE OF CONTENTS

CO2 CALIBRATION CHECK... 54 RETURNING THE MONITOR ... 58 TECHNICAL ASSISTANCE ... 58

SPECIFICATIONS... 59 PHYSICAL ... 59 Size ... 59 Weight (including battery pack)... 59 Noise Emission ... 59 ENVIRONMENTAL... 59 Temperature... 59 Pressure and Altitude (for operating and storage) ... 60 Transport and storage... 60 SAFETY STANDARDS ... 61 COMPLIANCE ... 61 PERFORMANCE ... 64 Electromagnetic Emissions ... 66 Electromagnetic Immunity... 67 Electromagnetic Immunity... 70 Recommended Separation Distances ... 72 POWER SPECIFICATIONS ... 73 External Power Source ... 73 Internal Power Source... 73 COMPONENTS AND USER INTERFACE... 74 Displays... 74 Controls and Indicators ... 74 Connections ... 74

v

TABLE OF CONTENTS

LIST OF FIGURES Figure 1: Monitor Front and Side View...10 Figure 2: Monitor Rear View...11 Figure 3: Initialization Screen ...18 Figure 4: Quick Guide...20 Figure 5: Monitor Display Screen and LEDs ...24 Figure 6 : Pump Off ...40 Figure 7: Pump Off Additional Time ...41 Figure 8: Pump Off/On Label ...41 LIST OF TABLES Table 1: Display Screens ...27 Table 2: Factory Default Alarm Range Values ...29 Table 3: Alarm Limits ...30 Table 4: Alarm Silence/Standby...32 Table 5: Instrument Settings Parameters (Menu1)...33 Table 6: Instrument Settings Parameters (Menu2)...34 Table 7: Changing Instrument Settings (Menu 1)...36 Table 8: Changing Instrument Settings (Menu 2)...37 Table 9: Institutional Settings...38 Table 10: Warning Messages ...46 Table 11: Caution Messages ...47 Table 12: Advisory Messages...48 Table 13: Silent Advisory Messages...49 Table 14: Troubleshooting Guide ...51 Table 15: Accessing the Service Mode ...53 Table 16: CO2 Calibration Check...56

vi

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

1

SAFETY INFORMATION

MRI Scanning 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 in the Basic Operation section of this manual.) 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. 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.

2

SAFETY INFORMATION

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. 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. This standardis 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.

3

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 Respiratory Rate (breaths per minute)

EtCO2

End tidal carbon dioxide value

DC Input

Connector Interface

Pump Off/On

4

Pump Off

INTRODUCTION Monitor Features

This manual provides directions for setup and operation of the portable capnograph monitor. The device is a portable bedside capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). 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, portable, lightweight monitor

• •

Displays CO2 waveforms and trends

•

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%.

Measures and displays EtCO2, and respiration rate, in one graphic and two digital displays Utilizes a wide range of Microstream EtCO2 consumables for all applications

Provides output for printer, PC, and Digital to Analog Converter

5

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 (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 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 7

OVERVIEW

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: 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 MRI Scanning, page 38) 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

8

OVERVIEW

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 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 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. 9

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/Value Change Button 6. Next/Menu Button 7. Battery Pack

10

8. Pump Off/On Adhesive Label 9. Event/Home Button 10. Port for AC Adapter or communication adapters 11. Alarm Silence/Alarm Silence Menu Button 12. Alarm Silence Indicator 13. Gas Outlet 14. Photo Resistor 15. 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 Connector 2. Space for Quick Guide Adhesive Label

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

11

INITIAL SETUP Power Requirements Unpacking & 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 to seven operating hours, depending on power management (refer to Table 5 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. Battery and Power Usage If power is lost when the monitor is operating from AC power, the monitor automatically switches to its internal battery pack for power.

13

INITIAL SETUP

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. During charging, if the instrument is on, 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 distributor. The recommended temperature for battery charging is between 5ºC and 45ºC. Important! The following information relates to the safe handling, storage, and disposal of the monitor battery pack.

14

INITIAL SETUP

Battery Testing The battery pack charge level should be tested before each use by observing the level on the battery icon after Self Test. For a correct reading, wait for the battery charge level to stabilize. Replace or recharge the battery pack when the advisory message, Battery !, appears on the graphic display screen (refer to the Troubleshooting section). Handling • Do not immerse the battery pack in water; it may malfunction.

•

Only recharge the battery pack in the monitor or use the Microstream Capnograph Battery Charger, provided by your local distributor, to avoid possible heating, burning or rupture of the battery pack.

Storage • Short-term storage (one month or less): The battery pack has an automatic discharge feature. You must periodically check the charge level of the battery pack.

•

Long-term storage (6 months or more): The battery pack must be stored in a cold, dry area. Its charge decreases over time. To restore the battery pack to full power, charge and discharge it three times before use. Long-term storage, without charging the battery, may degrade the battery capacity.

Disposal • Do not dispose of the battery pack in fire; it may explode.

•

Be sure to follow local governing ordinances and recycling instructions regarding disposal or recycling of batteries.

15

INITIAL SETUP

UNPACKING AND INSPECTION Components 1.

Remove the monitor and the accessories from the box carefully.

2.

Check that the items, listed in the table on the back cover of this manual, are included.

3.

Inspect each component. If the package is damaged or any component is missing, contact your local representative.

Optional Accessories The following items are available for use with the monitor:

• • • • • • • • • • • •

Protective Boot Carrying Case Clamp Rechargeable Battery Pack Microstream Capnograph Battery Charger Battery Pack Carrying Pouch Communication Adapter Kit Calibration Gas Kit Service Manual Digital to Analog (D/A) Converter Seiko DPU 414 Printer 12 Volt Cable Note: For information on operating the monitor with any accessory, refer to the specific accessory’s Directions for Use.

Important! To protect the unit, the manufacturer recommends using , the carrying case, the clamp, or the protective boot depending on the type of application.

16