COVIDIEN PURITAN BENNETT 980 (02) PDF MANUAL


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PDF Content Summary: Operator’s Manual Puritan Bennett TM 980 Series Ventilator

Copyright Information COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally regis tered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trade marks of a Covidien company. © 2013, 2015, 2018, 2019 COVIDIEN. The information contained in this manual is the sole property of Covidien and may not be duplicated without per mission. This manual may be revised or replaced by Covidien at any time and without notice. Ensure this manual is the most current applicable version. If in doubt, contact Covidien’s technical support department. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of profes sional judgment. The ventilator should be operated and serviced only by trained professionals. Covidien’s sole responsibility with respect to the ventilator and software, and its use, is as stated in the limited warranty provided. Nothing in this document shall limit or restrict in any way Covidien’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Covidien has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein. Table of Contents 1 Introduction 1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1 1.1.1 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 1.2 Global Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2 1.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3 1.3.1 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 1.3.2 Warnings Regarding Fire Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 1.3.3 General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 1.3.4 Warnings Regarding Environment of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 1.3.5 Warnings Before Using Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 1.3.6 Warnings Regarding Electrical Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 1.3.7 Warnings Regarding Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 1.3.8 Warnings Regarding Hoses, Tubing, and Accessories . . . . . . . . . . . . . . . . 1-8 1.3.9 Warnings Regarding Gas Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 1.3.10 Warnings Regarding Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 1.3.11 Warnings Regarding Ventilator Maintenance . . . . . . . . . . . . . . . . . . . . . . . 1-11 1.3.12 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 1.3.13 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12 1.4 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13 1.4.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13 1.4.2 On-Screen Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 1.5 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 1.6 Manufacture Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 1.7 Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 1.8 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17 2 Product Overview 2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1 2.2 Ventilator Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2 2.3 Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3 2.4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4 2.5 Components List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4 2.6 Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5 2.6.1 GUI Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 2.6.2 GUI Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 2.6.3 BDU Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 2.6.4 BDU Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8 i 2.6.5 Ventilator Side Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 2.7 Mounting Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13 2.8 Battery Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13 2.9 Graphical User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13 2.9.1 Primary Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 2.10 GUI Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 2.10.1 Control Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 2.10.2 GUI Touch Screen Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16 2.10.3 Visual Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16 2.10.4 On-screen Symbols and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19 2.10.5 Audible Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23 2.11 Breath Delivery Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23 2.11.1 BDU Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24 2.11.2 Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33 2.12 Additional Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34 2.13 Special Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34 2.14 Color Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34 2.15 Pneumatic Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35 3 Installation 3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1 3.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1 3.3 Product Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2 3.3.1 How to Assemble Ventilator Components . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 3.3.2 Product Power Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 3.4 Product Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4 3.5 Product Connectivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4 3.5.1 Connecting the Ventilator to AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 3.5.2 Connecting the Gas Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 3.5.3 Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 3.5.4 Connecting the Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12 3.6 How to Install Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16 3.6.1 Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16 3.6.2 Battery Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20 3.6.3 Battery Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20 3.6.4 Battery Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20 3.6.5 Flex Arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20 3.6.6 Humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21 3.7 Ventilator Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25 3.7.1 Normal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25 ii 3.7.2 Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25 3.7.3 Stand-By State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25 3.7.4 Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27 3.8 Product Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30 3.8.1 Preparing the Ventilator for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31 3.8.2 Configuring the GUI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32 3.9 Installation Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-38 3.9.1 SST (Short Self Test) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-39 3.9.2 EST (Extended Self Test) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-44 3.9.3 EST Test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-46 3.9.4 EST Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49 3.10 Operation Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-50 4 Operation 4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1 4.2 Ventilator Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1 4.3 Ventilator Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2 4.4 User Interface Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2 4.4.1 Using the GUI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 4.4.2 Adjusting GUI Viewing Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 4.4.3 Using Gestures When Operating the GUI . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 4.5 Ventilator Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7 4.5.1 Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9 4.5.2 Apnea Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13 4.5.3 Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14 4.5.4 Alarm Screen During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16 4.5.5 Making Ventilator Settings Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17 4.5.6 Constant Timing Variable During Rate Changes . . . . . . . . . . . . . . . . . . . . 4-17 4.6 Predicted Body Weight (PBW) Calculation . . . . . . . . . . . . . . . . . . . 4-18 4.7 Non-invasive Ventilation (NIV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19 4.7.1 NIV Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19 4.7.2 NIV Breathing Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19 4.7.3 NIV Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20 4.7.4 Conversion from INVASIVE to NIV Vent Type . . . . . . . . . . . . . . . . . . . . . . . 4-20 4.7.5 Conversion from NIV to INVASIVE Vent Type . . . . . . . . . . . . . . . . . . . . . . . 4-22 4.7.6 High Spontaneous Inspiratory Time Limit Setting . . . . . . . . . . . . . . . . . . 4-22 4.7.7 NIV Apnea Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23 4.7.8 NIV Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24 4.8 Manual Inspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24 4.9 Respiratory Mechanics Maneuvers . . . . . . . . . . . . . . . . . . . . . . . . . 4-25 iii 4.9.1 Inspiratory Pause Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26 4.9.2 Expiratory Pause Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27 4.9.3 Other Respiratory Maneuvers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28 4.10 Oxygen Sensor Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28 4.10.1 Oxygen Sensor Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29 4.10.2 Oxygen Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30 4.10.3 Oxygen sensor calibration testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30 4.11 Ventilator Protection Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30 4.11.1 Power on Self Test (POST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30 4.11.2 Technical Fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31 4.11.3 SST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31 4.11.4 Procedure Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31 4.11.5 Ventilation Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31 4.11.6 Safety Valve Open (SVO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31 4.11.7 Ventilator Inoperative (Vent Inop) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32 4.12 Ventilator Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32 5 Product Data Output 5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1 5.2 Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1 5.3 Data Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1 5.4 Data Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1 5.4.1 GUI Screen Capture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 5.4.2 Communication Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 5.4.3 Comm Port Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4 5.4.4 Serial Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 5.4.5 RSET Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 5.4.6 SNDA Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 5.4.7 SNDF Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9 5.5 Communication Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16 5.5.1 Port Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17 5.6 Retrieving Stored Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18 5.7 Display Configurability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18 5.8 Printing Data or Screen Captures . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18 5.9 Connectivity to External Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18 6 Performance 6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1 6.2 System Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1 iv 6.3 Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1 6.4 Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1 6.4.1 Ventilation Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 6.4.2 Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 6.4.3 Breath Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 6.5 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4 6.5.1 Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4 6.5.2 Alarm Reset Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 6.5.3 Audio Paused Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 6.5.4 Alarm Volume Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 6.5.5 Alarm Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8 6.5.6 Viewing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 6.5.7 Alarm Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 6.5.8 Alarm Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 6.5.9 AC POWER LOSS Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29 6.5.10 APNEA Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30 6.5.11 CIRCUIT DISCONNECT Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30 6.5.12 LOSS OF POWER Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30 6.5.13 DEVICE ALERT Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31 6.5.14 HIGH CIRCUIT PRESSURE Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31 6.5.15 HIGH DELIVERED O2% Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31 6.5.16 HIGH EXHALED MINUTE VOLUME Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32 6.5.17 HIGH EXHALED TIDAL VOLUME Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32 6.5.18 HIGH INSPIRED TIDAL VOLUME Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32 6.5.19 HIGH RESPIRATORY RATE Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33 6.5.20 INSPIRATION TOO LONG Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33 6.5.21 LOW CIRCUIT PRESSURE Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33 6.5.22 LOW DELIVERED O2% Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34 6.5.23 LOW EXHALED MANDATORY TIDAL VOLUME Alarm . . . . . . . . . . . . . . . 6-34 6.5.24 LOW EXHALED SPONTANEOUS TIDAL VOLUME Alarm . . . . . . . . . . . . . 6-35 6.5.25 LOW EXHALED TOTAL MINUTE VOLUME Alarm . . . . . . . . . . . . . . . . . . . . 6-35 6.5.26 PROCEDURE ERROR Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35 6.5.27 SEVERE OCCLUSION Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35 6.6 Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36 6.6.1 Total Exhaled Minute Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36 6.6.2 Exhaled Spontaneous Minute Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36 6.6.3 Exhaled Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37 6.6.4 Proximal Exhaled Minute Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37 6.6.5 Proximal Exhaled Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37 6.6.6 Exhaled Spontaneous Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37 6.6.7 Exhaled Mandatory Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37 v 6.6.8 Exhaled mL/kg Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37 6.6.9 Inspired Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37 6.6.10 Proximal Inspired Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38 6.6.11 Delivered mL/kg Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38 6.6.12 I:E Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38 6.6.13 Mean Circuit Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38 6.6.14 Peak Circuit Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38 6.6.15 End Inspiratory Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38 6.6.16 End Expiratory Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38 6.6.17 Intrinsic PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39 6.6.18 PAV-based Intrinsic PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39 6.6.19 Total PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39 6.6.20 Plateau Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39 6.6.21 Total Respiratory Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39 6.6.22 PAV-based Lung Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39 6.6.23 PAV-based Patient Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39 6.6.24 PAV-based Lung Elastance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-40 6.6.25 Spontaneous Rapid Shallow Breathing Index . . . . . . . . . . . . . . . . . . . . . . 6-40 6.6.26 Spontaneous Inspiratory Time Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-40 6.6.27 Spontaneous Inspiratory Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-40 6.6.28 PAV-based Total Airway Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-40 6.6.29 Static Compliance and Static Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-40 6.6.30 Dynamic Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42 6.6.31 Dynamic Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42 6.6.32 C20/C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42 6.6.33 End Expiratory Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42 6.6.34 Peak Spontaneous Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42 6.6.35 Displayed O2% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42 7 Preventive Maintenance 7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1 7.2 Ventilator Operational Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1 7.3 Preventive Maintenance Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1 7.4 Surface Cleaning of Exterior Surfaces . . . . . . . . . . . . . . . . . . . . . . . . .7-4 7.5 Component Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . .7-5 7.5.1 Exhalation Flow Sensor Assembly (EVQ) Disinfection . . . . . . . . . . . . . . . . 7-8 7.5.2 EVQ Reassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13 7.5.3 EVQ Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16 7.5.4 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17 7.6 Component Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17 vi 7.7 Service Personnel Preventive Maintenance . . . . . . . . . . . . . . . . . 7-19 7.8 Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20 7.9 Inspection and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20 7.10 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20 7.11 Storage for Extended Periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20 8 Troubleshooting 8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 8.2 Problem Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 8.3 How to Obtain Ventilator Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 8.4 Used Part Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 8.5 Ventilator Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2 8.6 Diagnostic Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4 9 Accessories 9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1 9.2 General Accessory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1 10 Theory of Operations 10.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 10.2 Theoretical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3 10.3 Applicable Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3 10.4 Inspiration — Detection and initiation . . . . . . . . . . . . . . . . . . . . . . 10-4 10.4.1 Pressure Triggering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4 10.4.2 Flow Triggering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5 10.4.3 Time Triggers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6 10.4.4 Operator-initiated Triggers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7 10.5 Exhalation — Detection and Initiation . . . . . . . . . . . . . . . . . . . . . . 10-7 10.5.1 Airway Pressure Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7 10.5.2 Percent Peak Flow Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8 10.5.3 Time-cycling Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9 10.5.4 Backup Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9 10.6 Compliance and BTPS Compensation . . . . . . . . . . . . . . . . . . . . . . 10-10 10.6.1 Compliance Compensation in Volume-based Breaths . . . . . . . . . . . . .10-10 10.6.2 BTPS Compensation in Volume-based Breaths . . . . . . . . . . . . . . . . . . . .10-13 10.7 Mandatory Breath Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13 10.7.1 Volume Control (VC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-14 10.7.2 Pressure Control (PC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-15 vii 10.7.3 VC+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-16 10.7.4 Rise time % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-17 10.7.5 Manual Inspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-18 10.8 Spontaneous Breath Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18 10.8.1 Pressure Support (PS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-20 10.8.2 Volume Support (VS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-20 10.8.3 Tube Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-22 10.8.4 Proportional Assist Ventilation (PAV™+) . . . . . . . . . . . . . . . . . . . . . . . . . . .10-25 10.9 A/C Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25 10.9.1 Changing to A/C Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-27 10.10 SIMV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28 10.10.1 Changing to SIMV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-30 10.11 Spontaneous (SPONT) Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-32 10.11.1 Changing to SPONT Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-33 10.12 Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-33 10.12.1 Apnea Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-33 10.12.2 Transition to Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-35 10.12.3 Settings Changes During Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . .10-35 10.12.4 Resetting Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-36 10.12.5 Apnea Ventilation in SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-36 10.12.6 Phasing in New Apnea Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-37 10.13 Detecting Occlusion and Disconnect . . . . . . . . . . . . . . . . . . . . . . . 10-37 10.13.1 Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-37 10.13.2 Disconnect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-38 10.13.3 Annunciating Occlusion and Disconnect Alarms . . . . . . . . . . . . . . . . . .10-40 10.14 Respiratory Mechanics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40 10.14.1 Inspiratory Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-41 10.14.2 Expiratory Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-43 10.14.3 Negative Inspiratory Force (NIF) Maneuver . . . . . . . . . . . . . . . . . . . . . . . .10-44 10.14.4 P0.1 Maneuver (Occlusion Pressure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-45 10.14.5 Vital Capacity (VC) Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-45 10.15 Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-46 10.15.1 Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-46 10.15.2 Circuit Type and Predicted Body Weight (PBW) . . . . . . . . . . . . . . . . . . .10-47 10.15.3 Vent Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-48 10.15.4 Mode and Breath Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-49 10.15.5 Respiratory Rate (f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-50 10.15.6 Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-51 10.15.7 Peak Inspiratory Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-51 10.15.8 Plateau Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-51 10.15.9 Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-52 viii 10.15.10Flow Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-52 10.15.11Pressure Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-52 10.15.12Inspiratory Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-53 10.15.13Inspiratory Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-53 10.15.14Expiratory Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-54 10.15.15I:E Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-54 10.15.16High Pressure in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-54 10.15.17Low Pressure in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-54 10.15.18High Time in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-54 10.15.19Low Time in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-55 10.15.20TH:TL Ratio in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-55 10.15.21PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-55 10.15.22Pressure Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-55 10.15.23Volume Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-56 10.15.24% Supp in TC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-56 10.15.25% Supp in PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-56 10.15.26Rise Time % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-56 10.15.27Expiratory Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-57 10.15.28Disconnect Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-57 10.15.29High Spontaneous Inspiratory Time Limit . . . . . . . . . . . . . . . . . . . . . . . . .10-58 10.15.30Humidification Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-58 10.15.31Humidifier Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-59 10.16 Safety Net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59 10.16.1 User Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-59 10.16.2 Patient Related Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-61 10.16.3 System Related Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-61 10.16.4 Background Diagnostic System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-61 10.17 Power On Self Test (POST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-63 10.18 Short Self Test (SST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-63 10.19 Extended Self Test (EST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-64 11 Specifications 11.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1 11.2 Measurement Uncertainty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1 11.3 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3 11.4 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7 11.5 Interface Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7 11.6 Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8 11.7 Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9 11.7.1 Ranges and Resolutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9 ix 11.8 Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-27 11.9 Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-29 11.10 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-36 11.11 Essential Performance Requirements . . . . . . . . . . . . . . . . . . . . . . 11-36 A BiLevel 2.0 A.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 A.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2 A.3 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2 A.4 Setting Up BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 A.5 Using Pressure Support with BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . A-4 A.6 Manual Inspirations in BiLevel Mode . . . . . . . . . . . . . . . . . . . . . . . . . A-5 A.7 Respiratory Mechanics Maneuvers in BiLevel . . . . . . . . . . . . . . . . . A-5 A.8 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6 A.9 Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6 A.9.1 Synchrony in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7 A.9.2 Patient Monitoring in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8 A.9.3 APRV Strategy in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8 A.9.4 Technical Structure of BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 A.10 Mode Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 B Leak Sync B.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1 B.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1 B.3 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1 B.4 Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2 B.5 Setting Up Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3 B.6 When Leak Sync is Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3 B.6.1 Adjusting Disconnect Sensitivity (DSENS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4 B.6.2 Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5 B.7 Technical Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-6 B.7.1 Inspired Tidal Volume (VTL) Accuracy During Leak Sync . . . . . . . . . . . . . B-7 B.7.2 Exhaled Tidal Volume (VTE) Accuracy During Leak Sync . . . . . . . . . . . . . . B-7 B.7.3 %LEAK Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7 B.7.4 Circuit Disconnect Alarm During Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . B-7 x C PAV™+ C.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1 C.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1 C.3 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1 C.4 PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-2 C.4.1 Setting Up PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4 C.4.2 PBW and Tube ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5 C.4.3 Apnea Parameters Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6 C.4.4 Alarm Settings Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6 C.4.5 PAV+ Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7 C.4.6 PAV+ Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7 C.4.7 Monitored Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8 C.4.8 PAV+ Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-9 C.5 Ventilator Settings/Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-9 C.5.1 Specified Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-10 C.5.2 Graphics Displays in PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-10 C.5.3 WOB Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-11 C.5.4 Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-12 C.5.5 Protection Against Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-15 D NeoMode 2.0 E Proximal Flow E.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1 E.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1 E.3 Proximal Flow Option Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1 E.3.1 Proximal Flow Option components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 E.4 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 E.5 Software/Hardware Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3 E.6 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3 E.7 On-screen symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5 E.8 Sensor Calibration and Sensor Line Purging . . . . . . . . . . . . . . . . . . .E-7 E.9 SST Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-8 E.9.1 Attaching the Proximal Flow Sensor for SST . . . . . . . . . . . . . . . . . . . . . . . . . E-9 E.10 Disabling/Enabling the Proximal Flow Option . . . . . . . . . . . . . . . .E-10 E.11 Using the Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-11 E.11.1 How to Perform a Manual Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-13 E.12 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-13 E.13 Ranges, Resolutions, and Accuracies . . . . . . . . . . . . . . . . . . . . . . . . .E-14 xi E.13.1 Proximal Flow Sensor Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-15 E.14 Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-15 Glossary Index xii List of Tables Table 1-1. Shipping Carton Symbols and Descriptions . . . . . . . . . . . . . . . . . . . . . . 1-2 Table 1-2. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Table 2-1. Typical Packing List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Table 2-2. BDU Front Label Symbols and Descriptions . . . . . . . . . . . . . . . . . . . . . . 2-8 Table 2-3. BDU Rear Label or Panel Symbols and Descriptions . . . . . . . . . . . . . . 2-9 Table 2-4. Common Symbols found on GUI or BDU Labels . . . . . . . . . . . . . . . .2-11 Table 2-5. GUI Control Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14 Table 2-6. GUI Visual Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16 Table 2-7. Symbols and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20 Table 2-8. GUI Audible Indicator Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23 Table 2-9. Status Display Indicators and Descriptions . . . . . . . . . . . . . . . . . . . . . .2-27 Table 2-10. BDU Audible Indicator Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-33 Table 2-11. Color Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-34 Table 3-1. Patient Types and PBW Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13 Table 3-2. Ventilator Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30 Table 3-3. SST test Sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-41 Table 3-4. Humidifier Volumes for Adult and Pediatric Patients . . . . . . . . . . . .3-42 Table 3-5. Humidifier Volumes for Neonatal Patients . . . . . . . . . . . . . . . . . . . . . .3-42 Table 3-6. Individual SST Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-43 Table 3-7. Overall SST Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-43 Table 3-8. EST Test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-47 Table 3-9. Individual EST Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-49 Table 3-10. Overall EST Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-49 Table 4-1. Gestures and Their Meanings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Table 4-2. Allowable Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13 Table 4-3. Setting Up a Patient for NIV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20 Table 4-4. INVASIVE to NIV on Same Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21 Table 4-5. NIV to INVASIVE on Same Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22 Table 5-1. MISCA Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6 Table 5-2. MISCF Response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10 Table 6-1. Alarm Descriptions and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6 Table 6-2. Alarm Prioritization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14 Table 6-3. Technical Alarm Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15 Table 6-4. Technical Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16 Table 6-5. Non-technical Alarm Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16 Table 6-6. Non-Technical Alarms and Suggested Responses. . . . . . . . . . . . . . .6-25 Table 7-1. Operator Preventive Maintenance Frequency. . . . . . . . . . . . . . . . . . . . 7-2 Table 7-2. Surface Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5 Table 7-3. Component Cleaning Agents and Disinfection Procedures . . . . . . 7-6 Table 7-4. Sterilization Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18 Table 7-5. Component Sterilization Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18 Table 7-6. Service Preventive Maintenance Frequency. . . . . . . . . . . . . . . . . . . . .7-19 Table 9-1. Accessories and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3 xiii Table 10-1. Compliance Volume Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13 Table 10-2. Maximum Pressure Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17 Table 10-3. Spontaneous Breath Delivery Characteristics. . . . . . . . . . . . . . . . . . 10-19 Table 10-4. Maximum Pressure Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21 Table 10-5. Inspiratory and Expiratory Pause Events. . . . . . . . . . . . . . . . . . . . . . . 10-42 Table 10-6. Values for VT Based on Circuit Type . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-48 Table 10-7. Peak Flow and Circuit Type (Leak Sync Disabled). . . . . . . . . . . . . . 10-48 Table 10-8. Modes and Breath Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-49 Table 10-9. Safety PCV Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-60 Table 10-10. Inspiratory Backup Ventilation Settings . . . . . . . . . . . . . . . . . . . . . . . 10-62 Table 11-1. Performance Verification Equipment Uncertainty . . . . . . . . . . . . . . .11-2 Table 11-2. Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-3 Table 11-3. Pneumatic Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-4 Table 11-4. Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-4 Table 11-5. Electrical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-7 Table 11-6. Interface Pin Designations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-7 Table 11-7. Nurse Call Pin Designations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-8 Table 11-8. Environmental Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-8 Table 11-9. Ventilator Settings Range and Resolution . . . . . . . . . . . . . . . . . . . . . .11-9 Table 11-10. Alarm Settings Range and Resolution . . . . . . . . . . . . . . . . . . . . . . . . 11-16 Table 11-11. Patient Data Range and Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . 11-18 Table 11-12. Delivery Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-25 Table 11-13. Monitoring (Patient Data) Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . 11-25 Table 11-14. Computed Value Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-27 Table 11-15. Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-30 Table 11-16. Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-30 Table 11-17. Immunity to Proximity Fields RF Wireless Communications Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-33 Table 11-18. AIM Standard Test Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-34 Table 11-19. Recommended Separation Distances for RF . . . . . . . . . . . . . . . . . 11-34 Table 11-20. Recommended Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-36 Table A-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2 Table B-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 Table B-2. Maximum Leak Compensation Flow Based on Patient Type. . . . . . B-2 Table B-3. DSENS Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5 Table C-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-2 Table C-2. Absolute limits for PAV+ Monitored Data . . . . . . . . . . . . . . . . . . . . . . . .C-8 Table C-3. PAV+ Work of Breathing terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-11 Table C-4. Default PBW-based Resistance Values . . . . . . . . . . . . . . . . . . . . . . . . . C-19 Table E-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3 Table E-2. Proximal Flow Option Data Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6 Table E-3. Proximal Flow Option SST test Sequence . . . . . . . . . . . . . . . . . . . . . . . . E-9 Table E-4. Proximal Flow Sensor Volume Accuracy . . . . . . . . . . . . . . . . . . . . . . . .E-15 Table E-5. Proximal Flow Sensor Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-15 Table E-6. Proximal Flow Option and Component Part Numbers . . . . . . . . . .E-15 xiv Table Glossary-1. Glossary of Ventilation Terms . . . . . . . . . . . . . . . . . . . . . . . . . .Glossary-1 Table Glossary-2. Units of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Glossary-8 Table Glossary-3. Technical Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Glossary-9 xv Page Left Intentionally Blank xvi List of Figures Figure 2-1. GUI Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Figure 2-2. GUI Rear View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 Figure 2-3. BDU Front View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Figure 2-4. BDU Rear View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8 Figure 2-5. Installed Software Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 Figure 2-6. Ventilator Right Side View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12 Figure 2-7. Ventilator Left Side View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13 Figure 2-8. Ventilator Power Switch and AC Indicator. . . . . . . . . . . . . . . . . . . . . . .2-24 Figure 2-9. Service Mode Button (TEST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25 Figure 2-10. Sample Status Display During Normal Ventilation . . . . . . . . . . . . . . .2-26 Figure 2-11. Pneumatic Diagram (Compressor Shown) . . . . . . . . . . . . . . . . . . . . . .2-35 Figure 2-12. Pneumatic Diagram — Compressor and Prox Flow Systems . . . .2-37 Figure 3-1. Example of Freestanding Ventilator Placement . . . . . . . . . . . . . . . . . . 3-4 Figure 3-2. Power Cord Retainer on BDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Figure 3-3. Connecting the Ventilator to the Gas Supplies . . . . . . . . . . . . . . . . . . . 3-7 Figure 3-4. Adult/Pediatric Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10 Figure 3-5. Installing the Neonatal Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11 Figure 3-6. Drain Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12 Figure 3-7. Connecting the Adult or Pediatric Patient Circuit . . . . . . . . . . . . . . .3-14 Figure 3-8. Connecting the Neonatal Patient Circuit. . . . . . . . . . . . . . . . . . . . . . . .3-15 Figure 3-9. Ventilator Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17 Figure 3-10. Proper Battery Orientation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18 Figure 3-11. Battery Compartment Locations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-19 Figure 3-12. Flex Arm Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-21 Figure 3-13. Bracket Installation on Rail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23 Figure 3-14. Humidifier Installation to Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24 Figure 3-15. Service Mode Button (TEST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-29 Figure 4-1. Areas of the GUI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Figure 4-2. Pushpin Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Figure 4-3. New Patient Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Figure 4-4. Open Menu Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10 Figure 4-5. New Patient Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10 Figure 4-6. Apnea Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14 Figure 4-7. Alarms Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15 Figure 4-8. Alarm Screen during Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16 Figure 4-9. Vent Setup Button “NIV” Indicating NIV vent type . . . . . . . . . . . . . . .4-22 Figure 4-10. 2TI SPONT Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23 Figure 4-11. Default NIV Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-24 Figure 4-12. RM in Menu Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25 Figure 4-13. Respiratory Maneuver Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26 Figure 4-14. More Settings Screen with O2 Sensor Enabled . . . . . . . . . . . . . . . . . .4-29 Figure 5-1. Incompatible USB Device Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Figure 5-2. Comm Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4 xvii Figure 5-3. Port Locations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16 Figure 6-1. Alarm Message Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5 Figure 7-1. EVQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9 Figure 7-2. EVQ Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9 Figure 7-3. EVQ Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10 Figure 7-4. Exhalation Valve Diaphragm Removal . . . . . . . . . . . . . . . . . . . . . . . . . .7-10 Figure 7-5. Exhalation Filter Seal Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-11 Figure 7-6. Pressure Sensor Filter Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-11 Figure 7-7. Immersion Method. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12 Figure 7-8. EVQ Reprocessing Kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14 Figure 7-9. Installing the Pressure Sensor Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14 Figure 7-10. Installing the Exhalation Filter Seal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15 Figure 7-11. Installing the Diaphragm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-16 Figure 7-12. Installing the EVQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-17 Figure 8-1. Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Figure 9-1. Ventilator with Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2 Figure 9-2. Additional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2 Figure 10-1. Inspiration Using Pressure Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5 Figure 10-2. Inspiration Using Flow Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6 Figure 10-3. Breath Activity During Time-triggered Inspiration . . . . . . . . . . . . . . .10-7 Figure 10-4. Exhalation via the Airway Pressure Method . . . . . . . . . . . . . . . . . . . . .10-8 Figure 10-5. Exhalation via the Percent Peak Flow Method. . . . . . . . . . . . . . . . . . .10-9 Figure 10-6. Square Flow Pattern. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10 Figure 10-7. Descending Ramp Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11 Figure 10-8. Ideal Waveform Using Square Flow Pattern . . . . . . . . . . . . . . . . . . . 10-14 Figure 10-9. Ideal Waveform Using Descending Ramp Flow Pattern . . . . . . . 10-15 Figure 10-10. Ideal Waveform Using Pressure Control Ventilation . . . . . . . . . . . 10-16 Figure 10-11. ET Tube Target Pressure vs. Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24 Figure 10-12. Tracheostomy Tube Target Pressure vs. Flow . . . . . . . . . . . . . . . . . 10-25 Figure 10-13. No Patient Inspiratory Effort Detected . . . . . . . . . . . . . . . . . . . . . . . . 10-26 Figure 10-14. Patient Inspiratory Effort Detected. . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-26 Figure 10-15. Combined VIM and PIM Breaths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27 Figure 10-16. Mandatory and Spontaneous Intervals. . . . . . . . . . . . . . . . . . . . . . . . 10-28 Figure 10-17. PIM Delivered Within Mandatory Interval . . . . . . . . . . . . . . . . . . . . . 10-28 Figure 10-18. PIM Not Delivered Within Mandatory Interval . . . . . . . . . . . . . . . . . 10-29 Figure 10-19. Apnea Interval Equals Breath Period . . . . . . . . . . . . . . . . . . . . . . . . . . 10-34 Figure 10-20. Apnea Interval Greater Than Breath Period. . . . . . . . . . . . . . . . . . . . 10-34 Figure 10-21. Apnea Interval Less Than Breath Period. . . . . . . . . . . . . . . . . . . . . . . 10-35 Figure 10-22. Apnea Ventilation in SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-36 Figure A-1. Spontaneous Breathing at PL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1 Figure A-2. BiLevel Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2 Figure A-3. BiLevel Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4 Figure A-4. BiLevel with Pressure Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-5 Figure A-5. Spontaneous and Synchronous Intervals . . . . . . . . . . . . . . . . . . . . . . . .A-7 Figure A-6. APRV With Spontaneous Breathing at PH . . . . . . . . . . . . . . . . . . . . . . . .A-8 xviii Figure B-1. Enabling Leak Sync. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3 Figure B-2. GUI Screen when Leak Sync is Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . B-4 Figure B-3. Leak Sync Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6 Figure B-4. Circuit Disconnect During VC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8 Figure C-1. Ventilator Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-5 Figure C-2. Graphics displays in PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-12 Figure C-3. Use of Default Lung Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-18 Figure E-1. Proximal Flow Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 Figure E-2. Sample GUI screen Showing Proximal Flow Data . . . . . . . . . . . . . . . . E-6 Figure E-3. Message During Autozero and Purge Processes . . . . . . . . . . . . . . . . . E-8 Figure E-4. Attaching Proximal Flow Sensor to Ventilator . . . . . . . . . . . . . . . . . . .E-10 Figure E-5. Enabling/disabling Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . .E-11 Figure E-6. Attaching Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-12 Figure E-7. Manual Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-13 Figure E-8. Alarm Message — Prox Inoperative. . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-14 xix Page Left Intentionally Blank xx 1 Introduction 1.1 Overview This manual contains information for operating the Puritan Bennett™ 980 Series Ventilators. Before operating the ventilator system, thoroughly read this manual. To obtain an additional copy of this manual, contact Covidien Customer Service or your local representative. 1.1.1 Related Documents Covidien makes available all appropriate information relevant to use and service of the ventila tor. For further assistance, contact your local Covidien representative. • The Puritan Bennett™ 980 Series Ventilator Operator’s Manual — Provides basic information on operating the ventilator and troubleshooting errors or malfunctions. Before using the ventilator, thoroughly read this manual. • The Puritan Bennett™ 980 Series Ventilator Service Manual — Provides information to Covidien trained service technicians for use when testing, troubleshooting, repairing, and upgrading the ven tilator. This chapter contains the following: • Symbol definitions • Safety Information, including Warnings, Cautions, and Notes • Technical assistance information • How to access on-screen Help • How to access warranty information • Serial number interpretation • Information regarding Electromagnetic susceptibility 1-1 Introduction 1.2 Global Symbol Definitions The following table describes the symbols shown on the ventilator shipping cartons. Other symbols appearing on various labels are shown in Chapter 2. Table 1-1. Shipping Carton Symbols and Descriptions Symbol Description CE Mark 0123: Signifies compliance with Medical Device Directive 93/42/ EEC Serial number

Part number Authorized representative Manufacturer This side up Fragile Humidity limitations: 10% to 95% relative humidity, non-condensing (operation and storage) Temperature limitations: 10°C to 40°C (50°F to 104°F) (operation) -20°C to 70°C (-68°F to 158°F) (storage) Atmospheric pressure limitations: 70 kPa to 106 kPa (10.2 psi to 15.4 psi) Keep dry CSA certification mark that signifies the product has been evaluated to the applicable ANSI/Underwriters Laboratories Inc. (UL) and CSA stan dards for use in the US and Canada.

1-2 Operator’s Manual Safety Information Table 1-1. Shipping Carton Symbols and Descriptions (Continued) Symbol Description This device is for sale by or on the order of a physician. Refer to instruction manual. 1.3 Safety Information 1.3.1 Safety Symbol Definitions This section contains safety information for users, who should always exercise appropriate caution while using the ventilator. Table 1-2. Safety Symbol Definitions Symbol Definition WARNING Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient, user, or environment. Caution Cautions alert users to exercise appropriate care for safe and effective use of the prod uct. Note Notes provide additional guidelines or information. 1.3.2 Warnings Regarding Fire Hazards  WARNING: Explosion hazard — Do not use in the presence of flammable gases. An oxygen-rich environment accelerates combustibility.  WARNING: To avoid a fire hazard, keep all components of the system away from all sources of ignition (such as matches, lighted cigarettes, flammable medical gases, and/or heaters). Oxygen-rich environments accelerate combustibility. Operator’s Manual 1-3 Introduction  WARNING: In case of fire or a burning smell, immediately take the following actions if it is safe to do so: disconnect the patient from the ventilator and disconnect the ventilator from the oxygen supply, facility power, and all batteries. Provide alternate method of ventilatory support to the patient, if required.  WARNING: Replacement of ventilator batteries by inadequately trained personnel could result in an unacceptable risk, such as excessive temperatures, fire, or explosion.  WARNING: To minimize fire hazard, inspect and clean or replace, as necessary, any damaged ventilator parts that come into contact with oxygen.  WARNING: To prevent electrostatic discharge (ESD) and potential fire hazard, do not use antistatic or electrically conductive hoses or tubing in or near the ventilator breathing system. 1.3.3 General Warnings  WARNING: To ensure proper operation and avoid the possibility of physical injury, only qualified medical personnel should attempt to set up the ventilator and administer treatment with the ventilator.  WARNING: In case of ventilator failure, the lack of immediate access to appropriate alternative means of ventilation can result in patient death. An alternative source of ventilation, such as a self-inflating, manually-powered resuscitator (as specified in ISO 10651-4 with mask) should always be available when using the ventilator.  WARNING: Patients on mechanical ventilation should be monitored by clinicians for proper patient ventilation.  WARNING: The ventilator system is not intended to be a comprehensive monitoring device and does not activate alarms for all types of conditions. For a detailed understanding of ventilator operations, be sure to thoroughly read this manual before attempting to use the ventilator system. 1-4 Operator’s Manual Safety Information  WARNING: To prevent patient injury, do not use the ventilator if it has a known malfunction. Never attempt to override serious malfunctions. Replace the ventilator and have the faulty unit repaired by trained service personnel.  WARNING: To prevent patient injury, do not make unauthorized modifications to the ventilator.  WARNING: To prevent injury and avoid interfering with ventilator operation, do not insert tools or any other objects into any ventilator openings.  WARNING: The audio alarm volume level is adjustable. The operator should set the volume at a level that allows the operator to distinguish the audio alarm above background noise levels. Reference To adjust alarm volume, p. 3-35 for instructions on alarm volume adjustment.  WARNING: Do not silence, disable, or decrease the volume of the ventilator’s audible alarm if patient safety could be compromised.  WARNING: If increased pressures are observed during ventilation, it may indicate a problem with the ventilator. Check for blocked airway, circuit occlusion, and/or run SST.  WARNING: The LCD panel contains toxic chemicals. Do not touch broken LCD panels. Physical contact with a broken LCD panel can result in transmission or ingestion of toxic substances.  WARNING: If the Graphical User Interface (GUI) display/LCD panel is blank or experiences interference and cannot be read, check the patient, then verify via the status display that ventilation is continuing as set. Because breath delivery is controlled independently from the GUI, problems with the display will not, by themselves, affect ventilation. The ventilator, however, should be replaced as soon as possible and repaired by qualified service personnel.  WARNING: The Puritan Bennett™ 980 Series Ventilator contains phthalates. When used as indicated, very limited exposure to trace amounts of phthalates may occur. There is no clear clinical evidence that this degree of exposure increases clinical risk. However, in order to minimize risk of phthalate exposure in children and nursing or pregnant women, this product should only be used as directed. Operator’s Manual 1-5 Introduction  WARNING: Even though the 980 Series Ventilator meets the standards listed in Chapter 11, the internal Lithium-ion battery of the device is considered to be Dangerous Goods (DG) Class 9 - Miscellaneous, when transported in commerce. The 980 Series Ventilator and/or the associated Lithium-ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport (IATA: International Air Transport Association), International Maritime Dangerous Goods code for sea and the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) for Europe. Private individuals who transport the device are excluded from these regulations although for air transport some requirements may apply. 1.3.4 Warnings Regarding Environment of Use  WARNING: Do not position the ventilator next to anything that blocks or restricts the gas inlet or cooling air circulation openings, gas exhaust port, fan intake, or alarm speaker, as this may: • limit the air circulation around the ventilator, potentially causing overheating; • limit the ventilator's ability to exhaust patient exhaled gas leading to potential harm; • limit the clinician’s ability to hear ventilator alarms.  WARNING: To avoid injury, do not position the ventilator in a way that makes it difficult to disconnect the patient.  WARNING: To ensure proper operation, do not position the ventilator in a way that makes it difficult to access the AC power cord.  WARNING: Do not use the ventilator in a hyperbaric chamber. It has not been validated for use in this environment.  WARNING: Do not use the ventilator in the presence of strong magnetic fields. Doing so could cause a ventilator malfunction.  WARNING: Do not use the ventilator during radiotherapy (i.e. cancer treatment using ionizing radiation), as doing so could cause a ventilator malfunction. 1-6 Operator’s Manual Safety Information  WARNING: To avoid the risk of ventilator malfunction, operate the ventilator in an environment that meets specifications. Reference Environmental Specifications, p. 11-8.  WARNING: Do not use the ventilator as an EMS transport ventilator. It has not been approved or validated for this use. 1.3.5 Warnings Before Using Equipment  WARNING: Before activating any part of the ventilator, be sure to check the equipment for proper operation and, if appropriate, run SST as described in this manual. Reference To run SST, p. 3-40.  WARNING: Check for leaks in the ventilator breathing system by running SST prior to ventilating a patient.  WARNING: Lock the ventilator’s casters during use to avoid the possibility of extubation due to inadvertent ventilator movement.  WARNING: The ventilator accuracies listed in the Ventilator Settings, Alarm Settings, and Patient Data tables in Chapter 11 are applicable under specified operating conditions. Reference Environmental Specifications, p. 11-8. If the ventilator is operated outside specified ranges, the ventilator may supply incorrect information and the accuracies listed in the aforementioned tables do not apply. A hospital Biomedical Technician must verify the ventilator is operated in the environmental conditions specified. 1.3.6 Warnings Regarding Electrical Power  WARNING: To avoid the risk of electrical shock: • Use only Covidien-branded batteries, adapters, and cables. • Do not use batteries, adapters or cables with visible signs of damage. • Do not touch internal components. Operator’s Manual 1-7 Introduction 1.3.7 Warnings Regarding Ventilator Settings  WARNING: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient, based on clinical judgment, the condition and needs of the patient, and the benefits, limitations and characteristics of the breath delivery options. As the patient's condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient's current needs.  WARNING: Avoid nuisance alarms by applying appropriate alarm settings.  WARNING: To prevent inappropriate ventilation, select the correct Tube Type (ET or Tracheostomy) and tube inner diameter (ID) for the patient’s ventilatory needs. Inappropriate ventilatory support leading to over-or under-ventilation could result if an ET tube or trach tube setting larger or smaller than the actual value is entered.  WARNING: Setting expiratory volume alarms to OFF increases the risk of not detecting a low returned volume.  WARNING: Setting any alarm limits to OFF or extreme high or low values can cause the associated alarm not to activate during ventilation, which reduces its efficacy for monitoring the patient and alerting the clinician to situations that may require intervention. 1.3.8 Warnings Regarding Hoses, Tubing, and Accessories  WARNING: To prevent electrostatic discharge (ESD) and potential fire hazard, do not use antistatic or electrically conductive hoses or tubing in or near the ventilator breathing system.  WARNING: Adding accessories to the ventilator can change the pressure gradient across the ventilator breathing system (VBS) and affect ventilator performance. Ensure that any changes to the ventilator circuit configurations do not exceed the specified values for circuit compliance and for inspiratory or expiratory limb total resistance. Reference Technical Specifications, p. 11-4. If adding accessories to the patient circuit, always run SST to establish circuit compliance and resistance prior to ventilating the patient. 1-8 Operator’s Manual Safety Information  WARNING: Use of a nebulizer or humidifier can lead to an increase in the resistance of inspiratory and exhalation filters. Monitor the filters frequently for increased resistance or blockage.  WARNING: During transport, the use of breathing tubing without the appropriate cuffed connectors may result in the circuit becoming detached from the ventilator.  WARNING: The added gas from an external pneumatic nebulizer can adversely affect spirometry, delivered O2%, delivered tidal volumes, and breath triggering. Additionally, aerosolized particulates in the ventilator circuit can lead to an increase in exhalation filter resistance.  WARNING: Carefully route patient tubing and cabling to reduce the possibility of patient entanglement or strangulation.  WARNING: Always use filters designed for use with the Puritan Bennett™ 980 Series Ventilator. Do not use filters designed for use with other ventilators. Reference Accessories and Options, p. 9-3 for relevant filter part numbers.  WARNING: To avoid liquid entering the ventilator, empty the expiratory condensate vial before fluid reaches the maximum fill line.  WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to IEC 60601-1. Furthermore, all configurations shall comply with the system standard IEC 60601- 1-1. Any person who connects additional equipment to the signal input part or signal output part of the ventilator system configures a medical system, and is therefore responsible for ensuring the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult Covidien Technical Services at 1.800.255.6774 or your local representative.  WARNING: Do not use HMEs (heat and moisture exchangers) and heated humidifiers together. This may result in the HME absorbing water and becoming obstructed, resulting in high airway pressures. Operator’s Manual 1-9 Introduction 1.3.9 Warnings Regarding Gas Sources  WARNING: Do not use nitric oxide, helium or mixtures containing helium with the ventilator. It has not been validated for use with these gas mixtures.  WARNING: To avoid the risk of ventilator malfunction, do not use the ventilator with anesthetic gases.  WARNING: For proper ventilator operation, use only clean, dry, medical grade gases when ventilating a patient.  WARNING: Use of only one gas source could lead to loss of ventilation and/or hypoxemia if that one gas source fails and is not available. Therefore, always connect at least two gas sources to the ventilator to ensure a constant gas supply is available to the patient in case one of the gas sources fails. The ventilator has two connections for gas sources: air inlet and oxygen inlet.  WARNING: Use of the ventilator in altitudes higher or barometric pressures lower than those specified could compromise ventilator operation. Reference Environmental Specifications, p. 11-8 for a complete list of environmental specifications.  WARNING: The ventilator should be connected to a gas pipeline system compliant to ISO 7396-1:2007 because: • Installation of the ventilator on a non-ISO 7396-1:2007 compliant gas pipeline system may exceed the pipeline design flow capacity. • The ventilator is a high-flow device and can interfere with the operation of other equipment using the same gas source if the gas pipeline system is not compliant to ISO 7396-1:2007. 1.3.10 Warnings Regarding Infection Control  WARNING: Patients receiving mechanical ventilation may experience increased vulnerability to the risk of infection. Dirty or contaminated equipment is a potential source of infection. It is recognized that cleaning, sterilization, sanitation, and disinfection practices vary widely among health care institutions. Always follow your hospital infection control guidelines for handling infectious material. Follow the instructions in this manual and your institution’s protocol for cleaning and sterilizing the ventilator and its components. Use all cleaning solutions and products with caution. 1-10 Operator’s Manual Safety Information Follow manufacturer’s instructions for individual cleaning solutions. Reference Chapter 7 of this manual.  WARNING: To prevent infection and contamination, always ensure inspiratory and exhalation bacteria filters are installed before ventilating the patient.  WARNING: Never attempt to re-use single patient use components or accessories. Doing so increases risk of cross-contamination and re-processing of single patient use components or accessories may compromise functionality leading to possible loss of ventilation. 1.3.11 Warnings Regarding Ventilator Maintenance  WARNING: To ensure proper operation and avoid the possibility of physical injury, this ventilator should only be serviced by qualified technicians who have received appropriate Covidien-provided training for the maintenance of this ventilator.  WARNING: Follow preventive maintenance according to specified intervals. Reference Operator Preventive Maintenance Frequency, p. 7-2. Reference Service Preventive Maintenance Frequency, p. 7-19. 1.3.12 Cautions Caution: To prevent possible equipment damage, ensure the casters are locked to prevent inadvertent movement of the ventilator during routine maintenance, or when the ventilator is on an incline. Caution: Do not use sharp objects to make selections on the display or keyboard. Caution: To ensure optimal performance, keep the GUI touch screen and keyboard clean and free from foreign substances. Reference Surface Cleaning Agents, p. 7-5. Caution: To avoid moisture entering the ventilator and possibly causing a malfunction, Covidien recommends using a wall air water trap when using piped medical air from a facility-based air compressor. Operator’s Manual 1-11 Introduction Caution: Use only the cleaning agents specified. Reference Surface Cleaning Agents, p. 7-5. for approved cleaning agents. Caution: Clean compressor inlet filter according to the interval listed in Chapter 7. Reference Operator Preventive Maintenance Frequency, p. 7-2. Caution: Do not block cooling vents. Caution: Ensure proper connection and engagement of exhalation and inspiratory filters. Caution: Follow instructions for proper GUI and BDU (breath delivery unit) mounting as described in the Puritan Bennett™ 980 Series Ventilator Installation Instructions. Caution: Follow proper battery installation instructions as described in this manual. Caution: When transferring the ventilator from storage conditions, allow its temperature to stabilize at ambient conditions prior to use. Caution: Remove extended and primary batteries from ventilator prior to transporting in a vehicle. Failure to do so could result in damage to the ventilator. 1.3.13 Notes Note: When using non-invasive ventilation (NIV), the patient’s actual exhaled volume may differ from the exhaled volume reported by the ventilator due to leaks around the mask. Note: When utilizing a closed-suction catheter system, the suctioning procedure can be executed using existing mode, breath type, and settings. To reduce potential for hypoxemia during the procedure, elevated delivered oxygen can be enabled using the Elevate O2 control. Reference To adjust the amount of elevated O2 delivered for two minutes, p. 3-34. 1-12 Operator’s Manual Obtaining Technical Assistance 1.4 Obtaining Technical Assistance 1.4.1 Technical Services For technical information and assistance, to order parts, or to order an Operator’s Manual or Service Manual, contact Covidien Technical Services at 1.800.255.6774 or a local Covidien repre sentative. Reference the following table for service centers in the USA and other countries. The Puritan Bennett™ 980 Series Ventilator Service Manual includes information necessary to service or repair the ventilator when used by qualified, factory-trained personnel. If unable to correct a problem while using the ventilator, contact Covidien Technical Services at 1.800.255.6774 or a local Covidien representative. The Service Manual, used by qualified, factory trained service personnel, provides additional troubleshooting information. When calling Covidien Technical Services, or a local Covidien representative, have the BDU and GUI serial numbers available, as well as the firmware version number of the ventilator system. The ventilator’s configuration is available by touching the wrench icon on the GUI screen. Have this information available whenever requesting technical assistance. The following table lists Covidien Service Centers, addresses, telephone, and Fax numbers:

Covidien Argentina Aguero 351 Capital Federal - 1171 ABC, Argentina Tel: (5411) 4863-5300 Fax: (5411) 4863-4142 Covidien Belgium BVBA/SPRL. Generaal De Wittelaan 9/5 2800 Mechelen Belgium Tel +32 15 29 44 50 Fax +32 15 29 44 55 Covidien China 2F, Tyco Plaza 99 Tian Zhou Rd Shang Hai 200233 P.R. China Tel: (+86) 4008 1886 86 Fax: (+86) 2154 4511 18 Covidien Asia Singapore Regional Service Centre 15 Pioneer Hub, #06-04 Singapore 627753 Tel (65) 6578 5288 Fax (65) 6515 5260 Covidien Brazil Av. Das Nações Undias 12995 Andar 23 - Brook lin São Paulo, SP Brasil 04578-000 Tel: (5511) 2187-6200 Fax: (5511) 2187-6380 Covidien Colombia Edificio Prados de la Morea Carretera Central Del Norte (Cra 7a)Kilometro 18, Chia-Cundinamarca Bogota, Colombia Tel: (571) 619-5469 Fax: (571) 619-5425 Covidien Australia 52A Huntingwood Drive Huntingwood, NSW 2148 Australia Tel: (+61) 1800 - 350702 Fax: (+61) 2967 - 18118 Covidien Canada 19600 Clark Graham Baie d'Urfe, QC, H9X 3R8 Canada Tel:1-514-695-1220, Select Option 2 Fax: 1-514-695-4965 Covidien Costa Rica Global Park, Parkway 50 La Auroa de Heredia Costa Rica Tel: (506) 2239 - 5386 Fax: (506) 2239 - 5319 Covidien Austria GmbH Campus21 Europaring F09402 Brunn am Gebrige A-2345 Österreich Tel: (+43) 2236 - 3788 39 Fax: (+43) 2236 - 3788 3940 Covidien Chile Camino lo Boza (Ex 8395) Pudehuel Santiago Chile Tel: (562) 739 - 3000 Fax: (562) 783 - 3149 Covidien ECE Prosecká 851/64 190 00 Prague Czech Republic Tel +42 024 109 57 35 Fax + 42 02 3900 0437

Operator’s Manual 1-13 Introduction

Covidien Danmark A/ S Langebrogade 6E, 4. th DK-1411 København K Danmark Tel +45 4368 2171 Fax:+45 4368 4511 18 Covidien France SAS 2 Rue Denis Diderot 78990 Elancourt France Tel +33 (0) 13079 80 00 Fax +33 (0) 130 79 80 30 Covidien Ireland Block G, Ground Floor, Cherrywood Business Park, Loughlinstown County Dublin, Ireland Tel +353 (0) 1.4073173 Fax +353(0) 1.4073174 Covidien Korea 5F, Hibrand Living Gwan, #215, Yangjae-Dong, Seocho-Gu Seoul, Korea Tel: +822 570 5459 Fax: +822 570 5499 Covidien Norge AS Bankveinen 1, Postboks 343 N-1372 Askerr Norway Tel +47 2415 98 87 Fax +47 2415 15 98 88 Covidien Puerto Rico Palmas Industrial Park Road 869 Km 2.0 Bdlg. #1 Cataño, PR 00962 Tel. 787-993-7250 Ext. 7222 & 7221 Fax 787-993-7234 Covidien Deutschland GmbH Gewerbepark 1r D-93333 Neustadt/ Donau Germany Tel + 49 (0) 9445 95 9 0 Fax + 49 (0) 9445 95 9 155 Covidien Hong Kong Unit 12 - 16, 18/F BEA Tower Millennium City 5 4187 Kwun Tong Road Kwum Tong, Kowloon, Hong Kong Tel + 852 3157 7299 Fax + 852 2838 0749 Covidien Israel 5, Shasham St. North Industrial Park POB3069 Caesarea, 38900 Tel +972 4.627 73 88 Fax+972 4.627 76 88 Covidien Mexico Insurgentes Sur # 863, Piso 16 Col. Nápoles Del. Benito Juarez Mexico, D.F. 03810 Mexico Tel: (5255) 5804-1524Fax: (5255) 5536-1326 Covidien Panama Parque Industrial Costa del Esta Calle Primera, Edifio # 109 Panama City, Panama Tel: (507) 264-7337 Fax: (507) 236-7408 Covidien Russia 53 bld. 5 Dubininskaya StreetMoscow RUSSIA. 119054 Tel +70 495 933 64 69 Fax +70 495 933 64 68 Covidien ECE Galvahiho 7 / A 832104 Bratislava Slovakia Tel +420 2 41 095 735 Fax +420 2 39 000 437 Covidien India 10th Floor Building No 9B DLF Cyber City Phase III Gurgaon Haryana - 122002 India Tel + 91 1244 709800 Fax + 91 1244 206850 Covidien Italia S.p.A Via Rivoltana 2/D I-20090 Segrate (Mi) Italy Tel +39 02 703 173 1 Fax +39 02 71740584 Covidien Nederland BV Hogeweg 105 NL5301 LL ZaltbommelNederland Tel0418 57 66 00 Fax 0418 57 67 91 Covidien Polska Al. Jerozolimskie 162 02-342 Warszawa. Polska Tel +48 22 312 20 00 Fax +48 22 312 20 20 Covidien Saglik A.S. Maslak Mahallesi Bilim Sokak No: 5, Sun Plaza Kat: 2-3 Sisli, Istanbul 34398 Turkey Tel +90 212 366 20 00 Fax +90 212 276 35 25 Covidien Finland Oy Pursimiehenkatu 26-39C PL407 FIN-00151 Helsinki Finland Te. +358 9725 192 88 Fax +358 9725 192 89 Covidien ECE Mariássy u.7. 1095 Budapest Hungary Tel + 36 1880 7975 Fax + 36 1777 4932 Covidien Japan Inc. Technical Support Center 83-1, Takashimadaira 1- Chome Itabashi-ku, Tokyo 175- 0082 Japan Tel: +81 (0) 3 6859 0120 Fax: +81 (0) 3 6859 0142 Covidien New Zealand Cnr Manu Tapu Dr & Joseph Hammond Pl. Auckland Airport New Zealand Phone: + 64 508 489 264 Covidien Portugal Lda. Produtos De Saúde Ida. Est: Outeiro Polima, Lote 10-1° Piso Abóboda P-2785-521 S. Domingos de Rana Portugal Tel +351 21 448 10 00 Fax +351 21 445 05 88 Covidien South Africa Corporate Park North 379 Roan Crescent RandjesparkMidrand, South Africa Tel +27 115 429 500 Fax +27 115 429 624

1-14 Operator’s Manual Obtaining Technical Assistance

Covidien Spain S.L. c/Fructuós Gelabert 6, 8a Planta 08970 Sant JoanDespí Barcelona, Spain Tel +34 93475 86 10 Fax +34 93 477 10 17 Covidien UK 4500 Parkway Whiteley, Fareham Hampshire PO157NY, United Kingdom Tel +44 (0) 1329 2240002 Fax +44 (0) 1329 220213 Covidien Sverige AB Hemvärnsgatan 9, Box 54 SE-171 74 Solna Sweden Tel +46(0)8517 615 73 Fax + 46 (0)8 517 615 79 Covidien USA 2101 Faraday Ave Carlsbad, CA 92008 Phone: 1-800-255-6774 (option 4 Email: VentTechSup port@covidien.com Covidien Switzerland Roosstrasse 53 Ch-8832 Wollerau Switzerland Tel +41(0)44 786 50 50 Fax +41 (0) 44 78650 10 Covidien Thailand 319 Chamchuri Square 17th Floor, Unit 1-8, Phayathai Road Pathumwan, Bangkok 10330, Thailand Tel +66-2 207-3 100 Fax +66-2 207 - 3101

For online Technical support, visit the SolvITSM Center Knowledge Base at covidien.com. The SolvIT Center provides answers to frequently asked questions about the ventilator system and other Puritan Bennett products 24 hours a day, seven days a week. 1.4.2 On-Screen Help The ventilator is equipped with an on-screen help system that enables users to select an item on the screen and display a description of that item. Follow the procedure below to access and use on-screen help. Accessing On-screen Help Topics Help topics on the ventilator are called tooltips. If a tooltip is available, a glowing blue outline appears around the item in question. To access tooltips 1. Touch the item in question for a period of at least 0.5 s, or drag the help icon (the question mark icon appear ing at the lower right of the GUI screen) to the item in question. A tooltip appears with a short description of the item. Most screen items have tooltips associated with them, providing the operator with access to a multitude of help topics. 2. Touch “more” on the dialog to display an expanded description. 3. Touch “close” to close the dialog, or let it fade away after five (5) s Note: • Dragging the help icon causes the tooltip to display in its unexpanded state. Operator’s Manual 1-15 Introduction • Dragging the help icon and pausing causes a tooltip to display. Continue dragging to another item to dismiss the last tooltip and display another tooltip. Other Resources Additional resources for information about the ventilator can be found in the Puritan Bennett™ 980 Series Ventilator Service Manual and appendices in this manual for BiLevel 2.0, Leak Sync, PAV+, NeoMode 2.0, and Proximal Flow Sensor options. 1.5 Warranty Information To obtain warranty information, for a covered product, contact Covidien Technical Services at 1.800.255.6774 or call a local Covidien representative. 1.6 Manufacture Date The graphical User Interface (GUI) and Breath Delivery Unit (BDU) each possess a specific year of manufacture applicable only for that assembly. These dates are contained in the serial numbers for each assembly or option. Serial numbers for the 980 Ventilator final units consist of ten digits, in the following format: 35ZYYXXXXX where • 35 signifies the unit was manufactured in Galway, Ireland • Z represents the product code (B= breath delivery unit, G= GUI, C = Compressor, P= Proximal Flow Monitoring option. The product codes shown here are typically the most common. There may be other product codes shown in the serial number depending upon the particular option(s) purchased. • YY is a two-digit year code that changes with each year • XXXXX is a sequential number that resets at the beginning of each new year Serial numbers are located on labels on the back panels of the GUI and BDU, and in various loca tions on product options. 1.7 Manufacturer Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Covidien Ireland Limited, IDA Business &Technology Park, Tullamore, Ireland. 1-16 Operator’s Manual Electromagnetic Compatibility 1.8 Electromagnetic Compatibility The ventilator system complies with the requirements of IEC 60601-1-2:2007, IEC 60601-1-2: 2014 (EMC Collateral Standard), and AIM Standard 7351731 Rev 2.00.2017. Certain transmitting devices (cellular phones, walkie-talkies, cordless phones, paging transmitters, RFID devices, etc.) emit radio frequencies that could interrupt ventilator operation if operated in a range too close to the ventilator. Practitioners should be aware of possible radio frequency interference if portable devices are operated in close proximity to the ventilator. The Puritan Bennett™ 980 ventilator requires special precautions to be taken regarding electro magnetic compatibility (EMC) and must be installed and put into service according to the EMC information provided in Chapter 11 in this manual. Operator’s Manual 1-17 Introduction Page Left Intentionally Blank 1-18 Operator’s Manual 2 Product Overview 2.1 Overview This chapter contains introductory information for the Puritan Bennett™ 980 Series Ventilator. Note: Items shown in bold-italic font are contained as entries in the glossary. Communication between the ventilator’s graphical user interface (GUI) and the breath deliv ery unit (BDU) occurs continuously via independent central processing units (CPUs). Reference Pneumatic Diagram (Compressor Shown), p. 2-35 and its associated reference desig nators when reading the following paragraphs. Gas delivery starts with the ventilator connected to wall (or bottled) air and oxygen. Gas travels to the mix module where gas pressures are regulated by their respective proportional solenoid valves (PSOLs). The PSOLs meter the gases according to the ventilator settings entered, then the gases flow through individual air and oxygen flow sensors into the mix manifold and accu mulator for mixing. The individual gas pressures are continuously monitored both before and after they are mixed in the mix manifold and accumulator assemblies. The mixed gas then flows to the inspiratory pneumatic system where it flows through the breath delivery flow sensor and then the inspiratory PSOL for delivery to the patient. Before the gas reaches the patient, it passes through an internal inspiratory bacteria filter, then through an external inspiratory bacteria filter attached to the ventilator’s gas outlet (the To patient port) where the breathing circuit is attached. When the gas returns from the patient, it flows through the expiratory limb of the breathing circuit, to the From patient port on the exhalation bacteria filter (which includes a condensate vial) before flowing through the exhala tion flow sensor and exhalation valve (EV). A gas exhaust port allows exhaled gas to exit the ventilator and flow to the room. The ventilator recognizes the patient’s breathing effort using pressure triggering (PTRIG) or flow triggering (VTRIG). During pressure triggering, as the patient inhales, the airway pressure decreases and the inspiratory pressure transducer (PI) monitors this pressure decrease. When the pressure drops to at least the value of the pressure sensitivity (PSENS) setting, the ventilator delivers a breath. During flow triggering, the difference between inspiratory and expiratory flows is monitored. As the patient inhales, the exhalation flow sensor measures less flow, while the delivery flow sensor measurement remains constant. When the difference between the two measurements is at least the value of the operator-set flow sensitivity (VSENS), the ventilator 2-1 Product Overview delivers a breath. If the patient is not inhaling, any difference between delivered flow and expira tory flow is due to flow sensor inaccuracy or leaks in the ventilator breathing circuit. To compen sate for leaks, which can cause autotriggering, the clinician can increase the VSENS setting or enable Leak Sync, if available. Note: Leak Sync is a software option. Details on its operation are provided in the Leak Sync appendix in this manual. A backup pressure triggering threshold of 2 cmH2O is also in effect. This provides enough pres sure sensitivity to avoid autotriggering, but will still allow the ventilator to trigger with acceptable patient effort. The exhalation valve controls Positive End Expiratory Pressure (PEEP) using feedback from the expiratory pressure transducer (PE). the valve controller also cycles the ventilator into the exhala tion phase if the PE measurement equals or exceeds the operator-set high circuit pressure limit. The PE measurement also controls when the safety valve (SV) opens. If PE measures 110 cmH2O or more in the ventilator breathing circuit, the safety valve opens, allowing the patient to breathe room air through the valve. 2.2 Ventilator Description The ventilator system is available in three models. All ventilators provide continuous ventilation to patients requiring respiratory support. • Puritan Bennett™ 980 Pediatric–Adult Ventilator — The Pediatric–Adult model ventilates pediat ric or adult patients with predicted body weights from 3.5 kg to 150 kg, and with tidal volumes from 25 mL to 2500 mL. • Puritan Bennett™ 980 Neonatal Ventilator — The Neonatal model ventilates neonatal patients with predicted body weights from 0.3 kg to 7.0 kg, and with tidal volumes for mandatory volume-con trolled breaths from 2 mL to 320 mL. • Puritan Bennett™ 980 Universal Ventilator — The Universal model ventilates neonatal, pediatric, and adult patients with predicted body weights from 0.3 kg to 150 kg, and with tidal volumes for man datory volume-controlled breaths from 2 mL to 2500 mL. To ventilate neonatal patients on the Pediatric–Adult or Universal models, the NeoMode 2.0 soft ware option is required. For details regarding the NeoMode 2.0 software option, reference the NeoMode 2.0 appendix in this manual. The ventilator should have a service life of approximately 10 years, provided the preventive main tenance schedule stated in the Puritan Bennett™ 980 Series Ventilator Service Manual is followed. The ventilator’s IEC 60601-1/EN 60601-1 classification is: 2-2 Operator’s Manual Indications For Use • Protection class I • Type BF • Mobile • Internally powered • IP 21 equipment • Continuous operation • Not suitable for use with flammable medical gases (not AP or APG) Reference BDU Rear Label or Panel Symbols and Descriptions, p. 2-9 for a description of the meaning of the IP classification. The ventilator system uses a graphical user interface (GUI) and breath delivery unit (BDU) for entering patient settings and delivering breaths to the patient. The GUI contains electronics capable of transferring the clinician’s input (by touching the screen) to the BDU where pneumatic and electronic systems generate the breathing parameters. 2.3 Indications For Use The Puritan Bennett™ 980 Ventilator System is designed for use on patient population sizes from neonatal (NICU) through adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hos pital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or noninvasively, to patients who require the following types of ventilator support: • Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasive ly (via mask or nasal prongs) • Assist/ Control, SIMV or Spontaneous modes of ventilation Note: Intended typical usage may be defined to include the following for the ventilator system Hospital Use — Typically covers areas such as general care floors (GCFs), operating rooms, special proce dure areas, intensive and critical care areas within the hospital and in hospital-type facilities. Hospital type facilities include physician office-base facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers. Intra-hospital transport — Includes transport of a patient within the hospital or hospital-type facility. All external hospital transportation (i.e. ambulance or aircraft) is excluded. Operator’s Manual 2-3 Product Overview 2.4 Contraindications Do not operate the ventilator in a magnetic resonance imaging (MRI) environment. 2.5 Components List Note: No parts of the ventilator system contain latex. Note: The components in the gas pathway that can become contaminated with bodily fluids or expired gases during both normal and single fault conditions are: • External inspiratory filter • Internal inspiratory filter • Exhalation filter and condensate vial • Exhalation valve assembly The typical ventilator system ships with the following packing list. Depending upon the ventilator system purchased, your list may vary. Table 2-1. Typical Packing List Quantity Item 1 Graphical User Interface 1 Breath Delivery Unit 1 Inspiratory filter 1 Exhalation filter 1 Condensate vial 2 Gas hoses (air and oxygen) 1 Standard caster base 1 Power cord 1 Operator’s Manual CD 1 Puritan Bennett™ 980 Series Ventilator Installation Instructions 1 Flex arm 1 Drain bag 1 Gold standard circuit (for running EST) 2-4 Operator’s Manual Product Views 2.6 Product Views 2.6.1 GUI Front View Figure 2-1. GUI Front View 1 Display brightness key 6 Inspiratory pause key 2 Display lock key 7 Expiratory pause key 3 Alarm volume key 8 Alarm reset key 4 Manual Inspiration key 9 Audio paused1 key 5 Rotary encoder (knob) 10 Omni-directional LED 1. The terms “audio paused” and “alarm silence” are interchangeable. Operator’s Manual 2-5 Product Overview 2.6.2 GUI Rear View Figure 2-2. GUI Rear View Reference Common Symbols found on GUI or BDU Labels, p. 2-11 for symbols found on the GUI or BDU. The “Do Not Push” symbol found on the GUI, only, is shown in this table. 2-6 Operator’s Manual Product Views 2.6.3 BDU Front View Figure 2-3. BDU Front View 1 Condensate vial 5 Power switch 2 Exhalation filter 6 Status display 3 Exhalation filter latch 7 Internal inspiratory filter 4 AC power indicator 8 Option connector panel door Operator’s Manual 2-7 Product Overview Table 2-2. BDU Front Label Symbols and Descriptions Symbol Description

2.6.4 BDU Rear View To Patient port From Patient port Exhalation filter latch locked (down)/unlocked (up)Figure 2-4. BDU Rear View

2-8 Operator’s Manual Product Views 1 Standard base 5 Service mode button 2 Air inlet 6 Remote alarm port 3 Oxygen inlet 7 Cylinder mount (optional) 4 Labels indicating installed software options Software option labels are applied to the grid located on the back of the ventilator, as shown below and in the previous image (item 4). Figure 2-5. Installed Software Options The following table lists the symbols and descriptions found on BDU or base labels. Table 2-3. BDU Rear Label or Panel Symbols and Descriptions Symbol Description This device is for sale by or on the order of a physician. User must consult instructions for use. Symbol is also found on “Do not obstruct” labels on both left and right sides of the ventilator, and on label indication supply gas connections. Keep away from fire or flame. Oxygen rich environments accelerate com bustibility. Atmospheric pressure limitations – The operational atmospheric pressure range 70 kPa to 106 kPa (10.2 psi to 15.4 psi). Operator’s Manual 2-9 Product Overview Table 2-3. BDU Rear Label or Panel Symbols and Descriptions (Continued) Symbol Description Humidity limitations – The operational humidity limit range 10% to 95%. Temperature limitations – The operational temperature limit range 50°F to 104°F (10°C to 40°C). Type BF applied part. IEC Ingress protection classification – Protected against ingress of fingers or similar objects and protected from condensation. Explosive hazard. Do not use in the presence of flammable gases. Authorized to bear the CSA certification mark signifying the product has been evaluated to the applicable ANSI/Underwriters Laboratories Inc. (UL) and CSA standards for use in the US and Canada. The ventilator contains components manufactured with phthalates. Potential equalization point (ground) (on AC panel). CB1 BDU Circuit Breaker (on AC panel). CB2 Compressor Circuit Breaker (on AC panel).

USB port (at rear of ventilator). HDMI port (at rear of ventilator). Service port (at rear of ventilator).

2-10 Operator’s Manual Product Views Table 2-3. BDU Rear Label or Panel Symbols and Descriptions (Continued) Symbol Description

Service Mode button (at rear of ventilator). Remote alarm port (at rear of ventilator). Ethernet connector (at rear of ventilator). Serial port (at rear of ventilator). Table 2-4. Common Symbols found on GUI or BDU Labels

Symbol Description CE Mark – Signifies compliance with Medical Device Directive 93/42/EEC.

Do Not Push – Do not push on the GUI Manufacturer – Name of the ventilator manufacturer. Authorized representative. Serial number. Manufacture date – The manufacture date is contained in the serial number. Reference Manufacture Date, p. 1-16 for details regarding inter pretation of the serial number. WEEE – Proper waste disposal. Follow local governing ordinances regard ing disposing of waste labeled with the WEEE symbol.

Operator’s Manual 2-11 Product Overview 2.6.5 Ventilator Side Views Figure 2-6. Ventilator Right Side View 2-12 Operator’s Manual Mounting Configurations Figure 2-7. Ventilator Left Side View 2.7 Mounting Configurations The ventilator system can be mounted as a free-standing unit standing at the patient’s bedside; the BDU with the GUI is mounted on a base with casters and includes a handle for ease of move ment. 2.8 Battery Backup The ventilator system uses a battery to provide backup power in case AC power is lost. When operating on battery power, the status display shows the “On Battery Power” image, and the GUI displays a rep resentation of battery charge levels. Reference Typical Status Display Indicators and Messages, p. 2-27 to for a description of the status display images and messages. An optional, extended battery is available to lengthen the amount of time the ventilator can operate on battery power. Reference Using Battery Power, p. 3-2. 2.9 Graphical User Interface There are two displays on the ventilator — the primary display (GUI) and the status display. Operator’s Manual 2-13 Product Overview 2.9.1 Primary Display The GUI incorporates a 15” display that rotates 170° about a vertical axis in either direction. The GUI can also be tilted up to 45° from vertical. The clinician enters ventilation parameters via the GUI’s touch screen, also known as the ventila tor’s primary display. The GUI’s keys activate other ventilator functions including screen bright ness, display lock, alarm volume, manual inspiration, inspiratory pause, expiratory pause, alarm reset, and audio paused. The GUI displays the following information depending on the state of the ventilator: • Ventilator, apnea, and alarm settings • Patient data • Waveforms • Current alarm banners 2.10 GUI Controls and Indicators 2.10.1 Control Keys The GUI bezel has eight off-screen control keys as shown below. Table 2-5. GUI Control Keys Key symbol Description Brightness control key — Adjusts the GUI screen brightness. Press the key and turn the knob to adjust the brightness. Display lock key — Actuates a lock to prevent inadvertent settings changes to the venti lator (including the knob function) while the display is locked. The display lock is useful when cleaning the touch screen. Press the key again to unlock the display. Also use the display lock key to reset the GUI touch screen as described in GUI Touch Screen Reset (2.10.2).

Alarm volume key — Adjusts the alarm volume. The alarm volume cannot be turned OFF.

2-14 Operator’s Manual GUI Controls and Indicators Table 2-5. GUI Control Keys (Continued) Key symbol Description Manual inspiration key — In A/C, SIMV, and SPONT modes, delivers one manual breath to the patient in accordance with the current mandatory breath parameters. In BiLevel mode, transitions from low pressure (PL) to high pressure PH) (or vice versa). To avoid breath stacking, a manual inspiration is not delivered during inspiration or during the restricted phase of exhalation. Reference Manual Inspiration, p. 10-18 for information on the restricted phase of exhalation. The Manual inspiration key can be used to deliver mandatory breaths to the patient or to run an inspiratory pause maneuver in SPONT mode. The manual inspiration key cannot be used to run an expiratory pause maneuver in SPONT mode. Inspiratory pause key — Initiates an inspiratory pause which closes the inspiratory and exhalation valves and extends the inspiratory phase of a mandatory breath for the pur poses of measuring end inspiratory pressure (PI END) for calculation of plateau pressure (PPL), static compliance (CSTAT), and static resistance (RSTAT). Expiratory pause key — Initiates an expiratory pause which extends the expiratory phase of the current breath in order to measure total PEEP (PEEPL). Alarm reset key — Clears active alarms or resets high-priority alarms and cancels an active audio paused condition. An alarm reset is recorded in the alarm log if there is an active alarm. DEVICE ALERT alarms cannot be reset. Audio paused key — Pauses alarms for 2 minutes. Cancel the audio paused function by touching the on-screen Cancel button. Operator’s Manual 2-15 Product Overview 2.10.2 GUI Touch Screen Reset On rare occasions, the GUI touch screen may become unresponsive. If you observe an unrespon sive GUI, inaccurate GUI responses, or unintended GUI responses, reset the touch screen to restore proper touch screen functionality. To reset the touch screen: 1. Touch the display lock key on the GUI bezel to lock the screen. The locked padlock icon appears on the screen and the display lock key illuminates. 2. Touch the display lock key again. Doing so displays a progress bar below the locked padlock icon, after which time the locked icon will “unlock,” indicating a successful GUI touch screen reset. Alternatively, ensure that a patient is not connected to the ventilator and power cycle the venti lator. Note: Do not touch the screen during the unlock period. Note: The manual GUI touch screen reset described in this section is different than the automatic 30-second transient reset of the GUI described in Table 2-9. 2.10.3 Visual Indicators The table below shows the GUI’s visual indicators. Reference Areas of the GUI, p. 4-3 for area names. The audio paused function has two visual indicators — the audio paused key on the GUI bezel glows yellow during an audio paused interval, and a visual countdown timer appears, showing the amount of time the audio paused interval has remaining. Table 2-6. GUI Visual Indicators Symbol Description Ventilator Setup (Vent Setup) button. Located at the lower left corner of the GUI. Touch this button to open the ventilator setup screen. Adult patient circuit indicator. Indicates adult circuit type tested during SST, and in use. Appears above the Vent Setup button. 2-16 Operator’s Manual GUI Controls and Indicators Table 2-6. GUI Visual Indicators (Continued) Symbol Description Pediatric patient circuit indicator. Indicates pediatric circuit type tested during SST, and in use. Appears above the Vent Setup button. Neonatal patient circuit indicator. Indicates neonatal circuit type tested during SST, and in use. Appears above the Vent Setup button. Home icon. A constant access icon. Reference Areas of the GUI, p. 4-3. Touch this icon to dismiss all open dialogs on the GUI screen. The display resumes showing the ventilator waveforms. Manual Event Touching this text causes the manual event screen to appear, where a variety of events can be recorded for viewing in the Trending layout. Reference the Trending addendum for more information about events Alarms icon. A constant access icon. Reference Areas of the GUI, p. 4-3.Touch this icon to display the alarm settings screen, which allows alarm limits to be changed. Logs icon. A constant access icon. Reference Areas of the GUI, p. 4-3. Touch this icon to display the logs screen, which contains tabs for Alarms, Settings, Patient Data, Diagnostics, EST/SST status, General Event, and Service logs. Elevate O2 control. A constant access icon. Reference Areas of the GUI, p. 4-3. Touch this icon to increase the set the elevated oxygen concentration to the institu tional default O2 configuration (if institutional default has been configured) for two minutes, or allows the operator to determine the additional per centage of oxygen to increase. The O2 concentration for the two-minute increase can be set to any value between 1% and 100% O2. If the Elevate O2 function is active, touching Extend re-starts the two-minute interval. The Elevate O2 function can be terminated prior to completion of the two-minute interval by touching Stop. Any time the Elevate O2 control is activated, an entry is made to the patient data log. Screen capture icon. A constant access icon. Refer ence Areas of the GUI, p. 4-3. Touch this icon to capture the image displayed on the GUI screen. Ref erence Areas of the GUI, p. 4-3 to read the complete procedure for capturing screen images. Operator’s Manual 2-17 Product Overview Table 2-6. GUI Visual Indicators (Continued) Symbol Description Help icon. A constant access icon. Reference Areas of the GUI, p. 4-3. Drag this icon to the item in question and release. A tooltip will appear describing the item’s function. Unread items icon. When this icon appears overlaid on another icon or tab (the logs icon, for example) it indicates there are unread items at this location. Configure icon. A constant access icon. Reference Areas of the GUI, p. 4-3. Touch this icon to display the configure screen. From this screen, perform all the SST tests or a single SST test. If performing a single test, all SST tests must subsequently be performed and passed in order to ventilate a patient. Pause icon. Located above the constant access icons. Touch this icon to pause the waveform graph. Waveform layout icon. Located above the constant access icons area.Touch this icon to open the wave form layout dialog. Grid lines icon. Located above the constant access icons area. Touch this icon to turn waveform grid lines ON or OFF. Maximize waveform icon. Located at the upper right portion of each waveform. Touch this icon to enlarge the waveform to its maximum size. Restore waveform icon. Restores waveform to its original size. Located at the upper right of the maxi mized waveform. Pushpin icon – pinned state. When in the pinned state, prevents a dialog from closing (under certain conditions). Located in the upper right corner of the GUI on the vent setup screen. Reference Pushpin Icon, p. 4-4. Pushpin icon – unpinned state. When the unpinned icon is touched, the pinned state becomes active. Located in the upper right corner of the GUI on the vent setup screen. Reference Pushpin Icon, p. 4-4

Low priority alarm icon (appears on alarm banner). Medium priority alarm icon (appears on alarm ban ner). High priority alarm icon (appears on alarm banner).

2-18 Operator’s Manual GUI Controls and Indicators 2.10.4 On-screen Symbols and Abbreviations Touch an on-screen symbol briefly (0.5 s) to display a tooltip on the GUI screen. The tooltip con tains a definition of the symbol and other descriptive text, available with either short or long descriptions. The short description expands to show more information by touching “more” on the tooltip dialog or collapses by touching less. The tooltip closes by touching close or fades in five (5) seconds if left alone. Expanding the tooltip dialog prevents the tooltip from timing out. Touching outside the tooltip causes the dialog to close. The table below summarizes the ventilator’s symbols and abbreviations. Operator’s Manual 2-19 Product Overview Table 2-7. Symbols and Abbreviations Symbol or Abbreviation Definition TA Apnea interval DSENS Disconnect sensitivity CDYN Dynamic compliance RDYN Dynamic resistance EEF End expiratory flow PI END End inspiratory pressure LEAK Exhalation leak PCIRC Monitored total circuit pressure LEAKY Exhalation leak at PEEP (Leak Sync enabled) as measured by the proximal flow sensor VTE MAND Exhaled mandatory tidal volume VE TOT Exhaled minute volume VE SPONT Exhaled spontaneous minute volume VTE SPONT Exhaled spontaneous tidal volume VTE Exhaled tidal volume ESENS Expiratory sensitivity TE Expiratory time

Flow pattern (ramp) Flow pattern (square)

VCIRC Monitored total inspiratory and expiratory flow VCIRC Y Monitored inspiratory and expiratory flow measured at the proximal airway VSENS Flow sensitivity VTRIG Flow triggering VY Inspiratory and expiratory patient flow PH High pressure setting (in BiLevel) PY Monitored circuit pressure throughout the breath cycle mea sured at the proximal airway TH High pressure time (in BiLevel) 2-20 Operator’s Manual GUI Controls and Indicators Table 2-7. Symbols and Abbreviations (Continued) Symbol or Abbreviation Definition TH:TL High pressure time to Low pressure time ratio (in BiLevel) I:E Inspiratory time to expiratory time (I:E) C20/C Inspiration compliance ratio VLEAK Inspiratory leak TI Inspiratory time PI Inspiratory pressure VTI Inspired tidal volume VTL Inspired tidal volume (when Leak Sync is enabled) PEEPI Intrinsic PEEP (auto PEEP) PEEPI PAV PAV-based intrinsic PEEP PL Low pressure setting (in BiLevel) TL Low pressure time (in BiLevel) PMEAN Mean circuit pressure NIF Negative inspiratory force O2% Oxygen percentage P0.1 Airway occlusion pressure at 100 ms CPAV PAV-based lung compliance EPAV PAV-based lung elastance % Supp Percent support setting for Tube Compensation and PAV+ RPAV PAV-based patient resistance RTOT PAV-based total airway resistance WOBTOT PAV-based work of breathing of patient and ventilator during inspiration PPEAK Peak circuit pressure PEF Peak expiratory flow VMAX Peak inspiratory flow PSF Peak spontaneous flow PEEP Set or monitored positive end expiratory pressure %Leak Percent leak PPL Plateau pressure Operator’s Manual 2-21 Product Overview Table 2-7. Symbols and Abbreviations (Continued) Symbol or Abbreviation DefinitionTPL Plateau time PCOMP Compensation pressure PSENS Pressure sensitivity PSUPP Pressure support level PTRIG Pressure triggering VTIY Proximal inspired tidal volume VTEY Proximal exhaled tidal volume VTI MANDY Proximal mandatory inspired tidal volume VTI SPONTY Proximal spontaneous inspired tidal volume VTLY Proximal inspired tidal volume with Leak Sync enabled f Respiratory rate or apnea respiratory rate

Rise time percent

f/VT Spontaneous rapid/shallow breathing index TSPONT Spontaneous inspiratory time TI/TTOT Spontaneous inspiratory time ratio CSTAT Static compliance RSTAT Static Resistance VT Tidal Volume VT CIRC Monitored total inspiratory and expiratory volumes VT Y Monitored inspiratory and expiratory patient volumes mea sured throughout the breath cycle at the proximal airway PEEPL Total PEEP fTOT Total respiratory rate (monitored) VC Vital Capacity VS Volume support 2-22 Operator’s Manual Breath Delivery Unit 2.10.5 Audible Indicators A tone sounds when a button on the GUI is touched, and also when settings are accepted. Audible indicators include pitched tones, beeps, and key clicks. Key clicks sound whenever a key on the GUI is pressed. Various tones annunciate patient alarms. Note: Pressing the audio paused key mutes alarms for the 2-minute audio paused period. Caregivers may choose to silence alarms by pressing the audio paused key. A 2-minute count down timer appears on the GUI during the audio paused interval. Cancel the audio paused func tion by touching Cancel. Table 2-8. GUI Audible Indicator Functions Function Description A series of two tones. Sounds when a low priority

Low priority alarm tone alarm occurs.

Medium priority alarm tone A repeating series of three tones. Sounds when a medium priority alarm occurs. High priority alarm tone A repeating series of five tones. Sounds when a high priority alarm occurs. Soft bound tone One tone. Sounds when a soft bound is reached when making changes to ventilator settings. A soft bound is a selected value that exceeds or goes below its limit and requires acknowledgment to continue. Hard bound tone (invalid entry) The invalid entry sound occurs when a hard bound is reached when making changes to ventilator set tings. A hard bound defines the upper or lower limit of the setting, where the setting cannot be adjusted higher or lower. The clinician enters ventilation parameters via the GUI’s touch screen. Reference GUI Front View, p. 2-5. The keys activate other ventilator functions. Reference GUI Control Keys, p. 2-14. 2.11 Breath Delivery Unit The breath delivery unit contains the hardware and software to enable the ventilator to provide patient support. Operator’s Manual 2-23 Product Overview 2.11.1 BDU Controls and Indicators BDU Controls • ON/OFF switch — Lift the switch cover and turn the ventilator ON or OFF. Figure 2-8. Ventilator Power Switch and AC Indicator 1 AC power indicator 2 ON/OFF switch • Service mode button — Press and release this button when the Covidien splash screen appears on the status display after powering on the ventilator to enter Service mode. 2-24 Operator’s Manual Breath Delivery Unit Figure 2-9. Service Mode Button (TEST) 1 Service mode button Note: The Covidien splash screen shows the Covidien logo and appears momentarily as a banner on the status display. BDU AC Indicator The status display and the AC power indicator are the only visual indicators on the BDU. The AC indicator illuminates green whenever the ventilator is connected to AC power. All other visual indicators on the ventilator are on the GUI. Reference Typical Status Display Indicators and Messages, p. 2-27 for a description of the status display indicators and symbols. Reference the section below for a summary of the information appearing on the status display. Status Display The status display is a separate display located on the BDU. Reference BDU Front View, p. 2-7, item 6. The status display provides the following information according to the state of the ventilator: During normal ventilation the status display shows • Current power source (AC or DC) • Safe State status: (Safety Valve Open (SVO) or Vent Inop Operator’s Manual 2-25 Product Overview • Presence of primary and extended batteries and their charging status • Relative available battery charge level • Circuit pressure graph displaying pressure units, 2PPEAK alarm setting and current PPEAK and PEEP values • Connection of air and oxygen • Ventilator operational hours • Visual indication of current alarm volume setting Note: The status display provides a redundant check of ventilator operation. If the GUI stops operating for any reason, ventilation continues as set. The figure below shows a sample of the status display during normal ventilation (compressor option not installed). Figure 2-10. Sample Status Display During Normal Ventilation

1 Primary and extended battery status (pres ence or absence). 6 PPEAK alarm setting

2 Alarm volume setting 7 Measured inspiratory pressure (changes as pressure changes) 3 Gas connection status 8 Selected pressure units 4 Power status 9 Measured PEEP 5 Measured peak circuit pressure (updated at the end of the current breath) 2-26 Operator’s Manual Breath Delivery Unit During Service mode the status display supplies • Ventilator serial number(s) • Ventilator operational time • EST and SST history • Power On Self Test (POST) status • Hours until next preventive maintenance is due • Gas pressure at the manifold inlets Reference Table 2-9. for status display possibilities. Typical Status Display Indicators and Messages The following table lists indicators and messages that appear on the status display. Table 2-9. Status Display Indicators and Descriptions Status Display Indicator or Message Meaning Splash screen. Appears when the ventilator’s power switch is turned on. When this image appears, press and release the TEST button at the back of the venti lator to enter Service mode. POST failure. This image appears if a POST error occurs at ventilator start-up, along with the error code (in this case a missing primary battery). Operator’s Manual 2-27 Product Overview Table 2-9. Status Display Indicators and Descriptions (Continued) Status Display Indicator or Message Meaning Failure of the exhalation flow sensor assembly (EVQ) during power on self test. Confirm proper installa tion of the exhalation flow sensor assembly and power cycle the ventilator. Failure of the EVQ during power on self test. Reinstall or replace the EVQ and run flow sensor calibration from Service mode. Prior to patient connection. The status display appears as shown when the patient has not been connected to the ventilator. Note the absence of PPEAK and PEEP values. Stand-by state. The status display appears as shown when the ventilator is in stand-by state. 2-28 Operator’s Manual Breath Delivery Unit Table 2-9. Status Display Indicators and Descriptions (Continued) Status Display Indicator or Message Meaning Battery charged. The ventilator’s primary battery (in the right-most slot) is shown fully charged, repre sented by a + symbol and green color. (Image shown without optional compressor installed). Battery charging. Identifies that the ventilator’s primary battery is charging. This icon is animated; orange bars scroll upward towards a “+” sign indicat ing the battery is charging. Green bars show the rel ative remaining battery capacity. If an extended battery is installed, the image shows a similar repre sentation in the extended battery location (left-most receptacle). (Image shown without optional com pressor installed). Battery icon. Denotes the ventilator is operating on battery power when this image appears on any status display indicator. Alerts the operator there is insufficient AC power to operate the ventilator. The indicator is replaced by the “on AC power” indicator when adequate AC power is restored. On battery power. Alerts the operator there is insuf ficient AC power to operate the ventilator. Ventilator is operating on battery power with greater than ten minutes of capacity remaining. Note the appearance of the battery icon. (Image shown without optional compressor installed). Operator’s Manual 2-29 Product Overview Table 2-9. Status Display Indicators and Descriptions (Continued) Status Display Indicator or Message Meaning Low battery. Identifies that the ventilator’s primary battery (right-most slot) is discharging and there are ten minutes or less of battery capacity remaining. A percentage indicator shows the remaining battery capacity. If an extended battery is installed, the image would show a similar representation in the extended battery location (left most slot). (Image shown without optional compressor installed). Critically low battery. Identifies that the ventilator’s primary battery has less than five minutes of battery capacity remaining. A percentage indicator shows the remaining battery capacity. If an extended battery is installed, the image would show a similar representation in the extended battery location. (Image shown without optional compressor installed). Power failure. Alerts the user that the ventilator’s battery is depleted or depletion is imminent. Replace primary or extended battery with a fully charged battery or connect ventilator to AC power. Battery Inoperative. This image appears on the status display when a battery fault renders the battery inoperative. (Image shown without optional com pressor installed). 2-30 Operator’s Manual Breath Delivery Unit Table 2-9. Status Display Indicators and Descriptions (Continued) Status Display Indicator or Message Meaning Battery not installed. This image appears when there is no primary battery installed, and renders the ven tilator inoperative. (Image shown without optional compressor installed). GUI Transient Reset. Indicates there is a transient loss of communication between the BDU and the GUI. It occurs in the ventilator by design to maintain full GUI display functionality. During the GUI transient reset, ventilation continues as currently set, audible and visual alarms are NOT annunciated, and the status display shows a count-down timer until the completion of the GUI transient reset. The count down lasts for approximately 30 s. GUI Failure. Indicates a loss of communication between the BDU and the GUI that cannot be recov ered by the ventilator system. During the GUI failure, ventilation continues as currently set, audible and visual alarms ARE annunciated, and the status display shows “Display Failed.” Replace the ventilator as soon as it is appropriate to do so. Service the ven tilator prior to returning it for use on patients. Recommended actions for GUI failure condition: • Verify the patient’s respiratory and physiological stability. • Confirm that the patient is receiving ventilatory support by observing expansion and contraction of the patient’s chest. • Assess patient status by reviewing other monitor ing indicators (for example, oxygen saturation, heart rate, blood pressure, etc.). • Transfer the patient to an alternate source of venti lation consistent with your institution’s protocol. Operator’s Manual 2-31 Product Overview Table 2-9. Status Display Indicators and Descriptions (Continued) Status Display Indicator or Message Meaning Ventilator inoperative (Vent Inop). Indicates the ven tilator is no longer capable of ventilating a patient and requires service. The alarm reset key cannot be used to restore function to the ventilator during a ventilator inoperative condition. Provide alternate means of ventilation immediately Note the display of the Safety valve open indicator. Safety valve open (SVO) indicator. During SVO, the patient can breathe room air through the safety valve, to the extent the patient is able to breathe unaided. Reference Safety Valve Open (SVO), p. 4-31. Backup Ventilation (BUV) indicator. Indicates the ventilator has entered the backup ventilation state. See Background Diagnostic System (10.16.4) on page 10-61 for a description of BUV. AC power indicator. When this image appears on any status display indicator, indicates the ventilator is operating on AC power. Status display appearance when ventilator is breath ing in Normal mode. Note the appearance of the AC power icon. 2-32 Operator’s Manual Breath Delivery Unit Table 2-9. Status Display Indicators and Descriptions (Continued) Status Display Indicator or Message Meaning Air available indicator. When this image appears on any status display indicator, indicates the ventilator is connected to a pressurized air source. O2 available indicator. Indicates ventilator is con nected to a pressurized O2 source. BDU Audible Indicators The continuous tone alarm is the only audible indicator in the BDU, and is described in Table 2-10. Table 2-10. BDU Audible Indicator Functions Indicator Description

Continuous tone alarm (Immediate priority) 2.11.2 Connectors A continuous tone annunciated when there is a Ventilator Inoperative (Vent Inop) condition. This alarm lasts for a minimum of two (2) minutes.

The ventilator incorporates the following connectors: • Ventilator outlet port (To patient) — A coaxial 15 mm (ID) / 22 mm (OD) conical connection to which the external inspiratory bacteria filter attaches. • Exhalation port (From patient) — The expiratory limb of the patient circuit attaches to the inlet of the exhalation bacteria filter. This port is compatible with a standard 22mm (OD) conical connection. • Proximal Flow sensor — A keyed pneumatic connector for the Proximal Flow Sensor is provided with a locking feature to prevent inadvertent disconnection. The proximal flow sensor measures flow and pressure at the patient wye. The Proximal Flow Sensor is an optional sensor. Details on operation are provided in the appendix in this manual. Reference Appendix E. • Standard interface connectors — USB, HDMI, and Ethernet connectors are provided. The USB connec tor allows screens to be captured on an external USB storage device and allows communication with an external patient monitor via serial over USB protocol, and the HDMI connector allow the GUI image to be displayed on an external video display device. The Ethernet connector is used by Service Personnel to upload new software and options. Reference Port Use, p. 5-17 for more information. Reference To configure Comm ports, p. 5-4 for information on serial over USB data transfer when configuring Comm ports for exter nal devices. Operator’s Manual 2-33 Product Overview 2.12 Additional Equipment An optional DC compressor is available to provide compressed air in the event the wall or bottled air supply is lost or is unavailable. The compressor receives DC power from its own power supply if AC power is present. If there is no AC power available, the compressor is powered by its internal battery. The compressor interface printed circuit board assembly (PCBA) communicates with the BDU CPU PCBA. Reference the Compressor Operator’s Manual Addendum for details regarding compressor operation.  WARNING: Use of the compressor in altitudes higher or barometric pressures lower than those specified could compromise ventilator/compressor operation. Reference Environmental Specifications, p. 11-8. 2.13 Special Features A Proximal Flow option is available. The proximal Flow Sensor is used to measure low flows and pressures associated with neonatal ventilation. If the ventilator is configured with this option, Ref erence Appendix E for more information. 2.14 Color Definitions Reference the following figures to view the ventilator’s pneumatic diagram during inspiration with various colors representing the gases as shown below. Table 2-11. Color Legend

Color or Symbol Description High-pressure Oxygen (NFPA 99 designation) High-pressure Air (NFPA 99 designation) Mixed gases, including air Atmosphere Vacuum Water

2-34 Operator’s Manual Pneumatic Diagrams 2.15 Pneumatic Diagrams The following figures illustrate the ventilator’s pneumatics with and without the optional Proximal Flow System. The Proximal Flow System is only for use with neonatal patients. Note: Both the compressor and the Proximal Flow System are hardware options. Figure 2-11. Pneumatic Diagram (Compressor Shown) Operator’s Manual 2-35 Product Overview 1 Pressure switch, mix accumulator (PS1) 24 Sensor, Oxygen (OS) 2 Solenoid Valve, options supply (SOL2) 25 Restrictor, breath delivery bypass (R2) 3 Pressure sensor, mix accumulator (PMX) 26 Flow sensor, patient gas delivery (FSD) 4 Accumulator, mix (ACCM) 27 Accumulator, compressor (ACCC) 5 Tube, mix (TM) 28 Relief valve, compressor accumulator (RVCA)

6 Proportional solenoid valve, patient gas delivery (PSOLD) 29 Solenoid valve, compressor unload (SOL7)

7 Solenoid valve, BUV (SOL 3) 30 Motor Compressor (MC) 8 Safety valve (SV) 31 Heat exchanger, compressor (HE) 9 Pressure sensor, safety valve (PSV) 32 Filter, compressor air (F7)

10 Solenoid valve, inspiratory pressure sensor autozero (SOL4) 33 Dryer, compressor

11 Pressure sensor, inspiratory (PI) 34 Filter, muffler (F6) 12 Pressure sensor, barometric (PA) 35 Check valve, compressor accumulator (CVCA) 13 Vial, exhalation condensate 36 Pressure sensor, compressor accumulator (PC) 14 Filter, exhalation (F4) 37 Check valve, Oxygen (CVO2) 15 Flow sensor assembly, exhalation valve 38 Check valve, Air (CVAir) 16 Exhalation valve (EV) 39 Proportional solenoid valve, Oxygen (PSOLO2) 17 Filter, exhalation pressure line (F5) 40 Flow sensor, Air (FSAir)

18 Solenoid Valve, exhalation pressure autoz ero (SOL 5) 41 Proportional solenoid valve, Air (PSOLAir)

19 Pressure sensor, exhalation (PE) 42 Pressure sensor, air gas inlet (PAir) 20 Humidifier 43 Restrictor, wall air bleed outlet (R1) 21 Filter, External bacteria (FD2) 44 Check valve, compressor air inlet (CVCAir) 22 Filter, Internal bacteria (FD1) 45 Filter bowl assembly, Air (WT2) 23 Check valve, patient gas delivery (CVD) 46 Filter element, Air (F2) 47 Check valve, wall Air inlet (CVWAir) 51 Flow sensor, Oxygen (FSO2) 48 Filter, Oxygen Impact (F1) 52 Restrictor, Prox Flow (R4) 49 Filter element, Oxygen (F3) 53 Relief Valve, mix accumulator (RVMA) 2-36 Operator’s Manual Pneumatic Diagrams 50 Pressure sensor, Oxygen gas inlet (PO2) 54 Solenoide Valve, mix accumulator purge (SOL 1) Figure 2-12. Pneumatic Diagram — Compressor and Prox Flow Systems 1 Restrictor, Prox Flow (R4) 6 Wye, patient circuit 2 Solenoid Valve, Prox Flow (SOL 6) 7 Sensor, Proximal Flow 3 Module, Proximal Flow System 8 Filter, neonatal exhalation

4 Pressure Sensor, Prox Flow Accumulator (PPROX) 5 Humidifier 9 Condensate vial, neonatal expiratory

Items enclosed by dotted line represent components internal to the ventilator. Operator’s Manual 2-37 Product Overview Page Left Intentionally Blank 2-38 Operator’s Manual 3 Installation 3.1 Overview This chapter contains information for the installation and set up of the Puritan Bennett™ 980 Series Ventilator. Before operating the ventilator system, thoroughly read this Operator’s Manual. Topics include: • Safety reminders • Ventilator setup • Battery information • Ventilator operating modes • Preparing the ventilator for use • Tests to perform prior to ventilating a patient 3.2 Safety Reminders  WARNING: Explosion hazard — Do not use in the presence of flammable gases. An oxygen-rich environment accelerates combustibility.  WARNING: To ensure proper operation and avoid the possibility of physical injury, only qualified medical personnel should attempt to set up the ventilator and administer treatment with the ventilator.  WARNING: To prevent electrostatic discharge (ESD) and potential fire hazard, do not use antistatic or electrically conductive hoses or tubing in or near the ventilator breathing system. 3-1 Installation  WARNING: Use only gas supply hoses approved by Covidien. Other hoses may be restrictive and may cause improper ventilator operation.  WARNING: To avoid possible injury, lock the ventilator’s casters prior to installing or removing ventilator components. Caution: To ensure optimum performance, Covidien recommends preventive maintenance be performed by factory-trained Biomedical Engineers per the schedule specified. Reference Service Preventive Maintenance Frequency, p. 7-19. 3.3 Product Assembly 3.3.1 How to Assemble Ventilator Components Ventilator setup should have already been completed by factory-trained service personnel including successfully passing EST. This manual does not include ventilator assembly instructions. 3.3.2 Product Power Sources Using AC Power The ventilator is normally AC-powered. Reference Connecting the Ventilator to AC Power, p. 3-4 to connect the ventilator to AC power. Using Battery Power  WARNING: Use only Covidien-branded batteries. Using other manufacturer’s brands could result in the batteries operating the ventilator for less than the specified amount of time or could cause a fire hazard.  WARNING: One primary battery must be installed at all times in the BDU’s primary battery slot for proper ventilator operation. The ventilator will not complete the startup process without the primary battery installed. Reference Battery Compartment Locations, p. 3-19 for identification of battery slots. 3-2 Operator’s Manual


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