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Table of Contents
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Summary of Contents for Masimo NomoLine ISA CO2
- Page 1 Operator's Manual ® NomoLine ISA™ CO2 Sidestream Gas Analyzer...
- Page 3 NomoLine® ISA™ CO2 (NomoLine ISA CO2). General knowledge of capnography monitoring and an understanding of the features and functions of NomoLine ISA CO2 are prerequisites for proper use. Do not operate NomoLine ISA CO2 without completely reading and understanding these instructions.
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Page 5: Table Of Contents
System Setup ------------------------------------------------------------------------------------------- 15 Chapter 3: Operation -------------------------------------------------------------------------------------- 17 LEGI Indicator ------------------------------------------------------------------------------------------ 17 Capnography Display ---------------------------------------------------------------------------------- 17 Chapter 4: Troubleshooting ------------------------------------------------------------------------------ 19 Troubleshooting NomoLine ISA CO2 --------------------------------------------------------------- 19 Chapter 5: Specifications --------------------------------------------------------------------------------- 21 Accuracy ------------------------------------------------------------------------------------------------- 21 Environmental ------------------------------------------------------------------------------------------ 21 Physical Characteristics ------------------------------------------------------------------------------- 22... - Page 6 NomoLine ISA CO2 Contents Repair Policy ------------------------------------------------------------------------------------------- 30 Return Procedure ------------------------------------------------------------------------------------- 30 Sales & End-User License Agreement ------------------------------------------------------------- 30 Limited Warranty -------------------------------------------------------------------------------------- 31 Exclusions ----------------------------------------------------------------------------------------------- 31 Limitation of Warranty -------------------------------------------------------------------------------- 31 End-User License -------------------------------------------------------------------------------------- 32 No Implied License ------------------------------------------------------------------------------------ 33 Index --------------------------------------------------------------------------------------------------------- 35 www.masimo.com...
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Page 7: About This Manual
This manual explains how to set up and use NomoLine® ISA™ CO2. Important safety information relating to general use of NomoLine ISA CO2 appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes. -
Page 9: Product Description, Features And Indications For Use
• NomoLine ISA CO2 is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. NomoLine ISA CO2 is also intended to be used in road ambulances. -
Page 11: Safety Information, Warnings And Cautions
Damage to the device may result in degraded performance and/or patient injury. WARNING: Do not start or operate the NomoLine ISA CO2 unless the setup was verified to be correct. Improper set-up of this device may result in degraded performance and/or patient injury. -
Page 12: Performance Warnings And Cautions
Specifications section in this manual. Performance Warnings and Cautions WARNING: NomoLine ISA CO2 should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: Use of high-frequency electrosurgical equipment in the vicinity of NomoLine ISA CO2 may produce interference and cause incorrect measurements. -
Page 13: Compliance Warnings And Cautions
NomoLine ISA CO2. These substances affect the device’s materials and device failure can result. CAUTION: Do not submerge the NomoLine ISA CO2 in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device. -
Page 15: Chapter 1: Description
Chapter 1: Description This chapter contains the description of the NomoLine ISA CO2 physical features. General System Description The NomoLine ISA CO2 system includes the following: • NomoLine ISA CO2 Device • NomoLine Sampling Line For a complete list of compatible NomoLine sampling lines, cannulas, and related consumables, visit www.masimo.com. -
Page 16: Nomoline Sampling Lines
As long as no sampling line is connected, the NomoLine ISA CO2 gas analyzer remains in a low-power sleep mode. Once the sampling line is connected, the NomoLine ISA CO2 gas analyzer switches to measuring mode and starts delivering gas data. -
Page 17: Chapter 2: Setting Up
Note: A bracket designed to mount NomoLine ISA CO2 is available, visit www.masimo.com. Connect the gas sample exhaust port on the rear of NomoLine ISA CO2 to a scavenging system if intended to be used in combination with N2O and/or anesthetic agents. -
Page 19: Chapter 3: Operation
Chapter 3: Operation The information in this chapter assumes that NomoLine ISA CO2 is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate NomoLine ISA CO2 without completely reading and understanding these nstructions. -
Page 21: Chapter 4: Troubleshooting
Possible Cause Correction • • NomoLine ISA CO2 Disconnect and reconnect the NomoLine ISA requires a power cycle NomoLine ISA CO2 connector at CO2 values are the host device. not displayed on • Host device is not host monitor •... - Page 22 NomoLine ISA CO2 Chapter 4: Troubleshooting Symptom Possible Cause Correction • • Incorrect sampling line Use the correct sampling line with Gas readings are used NomoLine ISA CO2. questionable • • Sampling line attached Disconnect and reconnect the incorrectly sampling line to NomoLine ISA CO2.
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Page 23: Chapter 5: Specifications
10% to 95% RH (non-condensing at ambient Storage/Transport Humidity temperature) Ambient CO ≤ 800 ppm Operating Atmospheric Pressure*** 525 mbar to 1,200 mbar (52.5 kPa to 120 kPa) Storage/Transport Atmospheric 200 mbar to 1,200 mbar (20 kPa to 120 kPa) Pressure www.masimo.com Masimo... -
Page 24: Physical Characteristics
NomoLine ISA CO2 Chapter 5: Specifications * A warm up period of 10 minutes is required for the NomoLine ISA CO2 to fulfill the accuracy specification if immediately put into use after being stored at −40°C. See Chapter 4: Troubleshooting on page 19 for additional information. -
Page 25: Additional Specifications
NomoLine ISA CO2 Chapter 5: Specifications Safety Standards Compliance EN 30301-1:2006/AMD1:2013 IEC 60601-1-12:2014 ANSI/AAMI ES60601-1:2005/A1:2012 CAN/CSA C22.2 No. 60601-1:2014 Equipment Classification per IEC 60601-1 Type of Protection Class II Degree of Protection of Electrical Shock Defibrillation proof BF-Applied Part Protection against harm from liquid... - Page 26 NomoLine ISA CO2 Chapter 5: Specifications Data Output Specifications Breath detection Adaptive threshold, minimum 1 vol% change in CO concentration. Respiration rate 0 to 150 ± 1 breaths/min Fi and ET **** Fi and ET are displayed after one breath and have a continuously updated breath average.
- Page 27 NomoLine ISA CO2 Chapter 5: Specifications Gas Analyzer Specifications Analyzer System < 3 seconds Response Time ***** An automatic zeroing is performed. See Zeroing on page 30. Effects from Water Vapor Partial Pressure on Gas Readings When the breathing gas flows through the sampling line, the gas temperature will adapt to the ambient temperature before reaching the gas analyzer.
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Page 28: Symbols
NomoLine ISA CO2 Chapter 5: Specifications Gas or Vapor Gas Level CO (Carbon Monoxide) 1 vol% NO (Nitrogen Monoxide) 0.02 vol% 100 vol% Note 1: Negligible interference, effect included in the specification “Accuracy, all conditions” above. Note 2: Negligible interference with N... - Page 29 NomoLine ISA CO2 Chapter 5: Specifications Symbol Description Symbol Description Catalog number (model number) Not made with natural rubber Lot Code latex Storage temperature range Fragile, handle with care Keep dry Atmospheric pressure limitation Do not use if package is...
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Page 31: Chapter 6: Service And Maintenance
Chapter 6: Service and Maintenance Cleaning Cleaning of the NomoLine ISA CO2 should be performed at regular intervals or in accordance with hospital, as well as local and governmental regulations. See Safety Information, Warnings and Cautions on page 9. WARNING: To avoid electric shock, always physically disconnect the NomoLine ISA CO2 and all patient connections before cleaning. -
Page 32: Repair Policy
Please clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Cleaning Procedure. Make sure the equipment is fully dry before packing. To return the NomoLine ISA CO2 for service, please follow the Return Procedure below on page 30. Return Procedure Clean contaminated/dirty equipment before returning, following instructions in the Cleaning Procedure section. -
Page 33: Limited Warranty
Products or Software. In no event shall Masimo’s liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or Software. -
Page 34: End-User License
Masimo. Masimo sensors that are designated for single use are licensed under Masimo patents for use on a single patient only, and are not sold. Masimo reusable sensors are licensed under Masimo patents for use on more than a single patient, but are not sold. -
Page 35: No Implied License
Agreement and shall be prohibited except to the extent expressly permitted by the terms of this Agreement. 10. Patents. The Masimo technology in the Masimo product is covered under one or more patents set forth at www.masimo.com/patents.htm. -
Page 37: Index
End-User License • 32 Repair Policy • 30 Environmental • 21 Return Procedure • 30 Exclusions • 31 Safety Information, Warnings and Features • 13 Cautions • 9, 29 Front View • 13, 15 Safety Warnings and Cautions • 9 www.masimo.com Masimo... - Page 38 NomoLine ISA CO2 Index Sales & End-User License Agreement • Sampling Line Replacement • 14, 19, 20 Symbols • 26 System Setup • 13, 15 Troubleshooting NomoLine ISA CO2 • 19 Zeroing • 17, 25, 30 www.masimo.com Masimo...
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