Medtronic PuritanBennett980Ventilator_OperatorsManual_en_US_PT00109658A00 IRIS Medical Operating Microscope Adapter Operator Manual

Operator's Manual

Puritan Bennett

980 Series Ventilator

©2012–2019 Covidien. COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company.

The information contained in this manual is the sole property of Covidien and may not be duplicated without permission. 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 or visit the Puritan Bennett™ product manual web page at:

www.medtronic.com/covidien/support/product-manuals

Click Acute Care Ventilation > PuritanBennett™ 980 Ventilator> then follow the prompts to select the desired manual.

While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13

1.5 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

1.6 Manufacture Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

1.7 Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

1.8 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

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

2.6.5 Ventilator Side Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

2.7 Mounting Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

2.8 Battery Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Operator’s Manual iii

2.9 Graphical User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

2.9.1 Primary Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

2.10 GUI Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

2.10.1 Control Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-22

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

3.5.1 Connecting the Ventilator to AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

3.5.2 Connecting the Gas Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7

3.5.3 Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

3.5.4 Connecting the Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13

3.6 How to Install Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

3.6.1 Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17

3.6.2 Battery Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-21

3.6.3 Battery Performance Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-21

3.6.4 Battery Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

3.6.5 Battery Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

3.6.6 Flex Arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

3.6.7 Humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24

3.7 Ventilator Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28

3.7.1 Normal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28

3.7.2 Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28

3.7.3 Stand-By State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28

3.7.4 Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30

3.8 Product Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32

3.8.1 Preparing the Ventilator for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33

3.8.2 Configuring the GUI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-34

iv Operator's Manual

3.9 Installation Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-41

3.9.1 SST (Short Self Test) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-41

3.9.2 Flow Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-47

3.9.3 Extended Self Test (EST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-50

3.9.4 EST Test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-52

3.9.5 EST Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-55

3.10 Operation Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-56

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 Respiratory Rate Changes . . . . . . . . . . . . . . . . . . . . . . . . . .4-18

4.6 Predicted Body Weight (PBW) Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

4.7 Non-invasive Ventilation (NIV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

4.7.1 NIV Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

4.7.2 NIV Breathing Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

4.7.3 NIV Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

4.7.4 Conversion from Invasive to NIV Ventilation Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

4.7.5 Conversion from NIV to Invasive Ventilation Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

4.7.6 High Spontaneous Inspiratory Time Limit Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

4.7.7 NIV Apnea Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-24

4.7.8 NIV Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-24

4.8 Manual Inspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

4.9 Respiratory Mechanics Maneuvers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

4.9.1 Inspiratory Pause Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27

4.9.2 Expiratory Pause Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28

4.9.3 Other Respiratory Maneuvers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29

4.10 Oxygen Sensor Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

4.10.1 Oxygen Sensor Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-30

4.10.2 Oxygen Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-31

4.10.3 Oxygen Sensor Calibration Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-31

4.11 Ventilator Protection Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

4.11.1 Power On Self Test (POST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-31

Operator's Manual v

4.11.2 Technical Fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-32

4.11.3 SST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-32

4.11.4 Procedure Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-32

4.11.5 Ventilation Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-32

4.11.6 Safety Valve Open (SVO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-32

4.11.7 Ventilator Inoperative (Vent Inop) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-33

4.12 Ventilator Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19

5.7 Display Configurability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19

5.8 Printing Data or Screen Captures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19

5.9 Connectivity to External Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19

6 Performance

6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.2 System Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8

6.5.5 Alarm Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

6.5.6 Viewing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13

6.5.7 Alarm Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13

vi Operator's Manual

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-31

6.5.13 DEVICE ALERT Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-31

6.5.14 HIGH CIRCUIT PRESSURE (

6.5.15 HIGH DELIVERED O

% (1O2%) Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-32

6.5.16 HIGH EXHALED MINUTE VOLUME (

6.5.17 HIGH EXHALED TIDAL VOLUME (

6.5.18 HIGH INSPIRED TIDAL VOLUME (

6.5.19 HIGH RESPIRATORY RATE (

) Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-31

PEAK

VTE) Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-32

VTI) Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-32

) Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-33

TOT

) Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-32

E TOT

6.5.20 INSPIRATION TOO LONG Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-33

6.5.21 LOW CIRCUIT PRESSURE (

6.5.22 LOW DELIVERED O

% (3O2%) Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-34

6.5.23 LOW EXHALED MANDATORY TIDAL VOLUME (

6.5.24 LOW EXHALED SPONTANEOUS TIDAL VOLUME (

6.5.25 LOW EXHALED TOTAL MINUTE VOLUME (

) Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-33

PEAK

TE MAND

) Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-35

E TOT

) Alarm . . . . . . . . . . . . . . . . . . . . .6-34

TE SPONT

) 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 (

6.6.2 Exhaled Spontaneous Minute Volume (

6.6.3 Exhaled Tidal Volume (V

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-36

6.6.4 Proximal Exhaled Minute Volume (

6.6.5 Proximal Exhaled Tidal Volume (V

6.6.6 Exhaled Spontaneous Tidal Volume (V

6.6.7 Exhaled Mandatory Tidal Volume (V

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-36

E TOT

E SPONT

E TOTY

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37

TEY

TE SPONT

TE MAND

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-36

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37

6.6.8 Exhaled mL/kg Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37

6.6.9 Inspired Tidal Volume (V

6.6.10 Proximal Inspired Tidal Volume (V

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37

TIY

6.6.11 Delivered mL/kg Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-38

6.6.12 I:E Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-38

6.6.13 Mean Circuit Pressure (P

6.6.14 Peak Circuit Pressure (P

6.6.15 End Inspiratory Pressure (P

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-38

MEAN

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-38

PEAK

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-38

I END

6.6.16 End Expiratory Pressure (PEEP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-38

6.6.17 Intrinsic PEEP (PEEP

6.6.18 PAV-based Intrinsic PEEP (PEEP

6.6.19 Total PEEP (PEEP

6.6.20 Plateau Pressure (P

6.6.21 Total Respiratory Rate (f

6.6.22 PAV-based Lung Compliance (C

6.6.23 PAV-based Patient Resistance (R

6.6.24 PAV-based Lung Elastance (E

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-38

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-39

I PAV

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-39

TOT

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-39

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-39

TOT

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-39

PAV

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-39

PAV

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-39

PAV

Operator's Manual vii

6.6.25 Spontaneous Rapid Shallow Breathing Index (f/VT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-40

6.6.26 Spontaneous Inspiratory Time Ratio (T

6.6.27 Spontaneous Inspiratory Time (T

I SPONT

6.6.28 PAV-based Total Airway Resistance (R

6.6.29 Static Compliance (C

6.6.30 Dynamic Compliance (C

6.6.31 Dynamic Resistance (R

6.6.32 C

/C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42

) and Static Resistance (R

STAT

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42

DYN

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42

DYN

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-40

I/TTOT

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-40

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-40

TOT

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-40

STAT

6.6.33 End Expiratory Flow (EEF) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42

6.6.34 Peak Spontaneous Flow (PSF) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42

6.6.35 Displayed O

6.6.36 Inspiratory Time Constant (3Tau

% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

7.5 Component Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

7.5.1 Exhalation Flow Sensor Assembly (EVQ) Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

7.5.2 EVQ Reassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12

7.5.3 EVQ Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14

7.5.4 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15

7.6 Service Personnel Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15

7.7 Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16

7.8 Inspection and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16

7.9 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17

7.10 Storage for Extended Periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17

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

viii Operator's Manual

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

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

Operator's Manual ix

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 P

Maneuver (Occlusion Pressure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-45

0.1

10.14.5 Vital Capacity (VC) Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-46

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 Ventilation 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 (V

10.15.7 Peak Inspiratory Flow (

10.15.8 Plateau Time (T

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-51

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-51

MAX

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-51

10.15.9 Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-51

10.15.10 Flow Sensitivity (

10.15.11 Pressure Sensitivity (P

10.15.12 Inspiratory Pressure (P

10.15.13 Inspiratory Time (T

10.15.14 Expiratory Time (T

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52

SENS

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52

SENS

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-53

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-53

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54

10.15.15 I:E Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54

10.15.16 High Pressure (P

10.15.17 Low Pressure (P

10.15.18 High Time (T

10.15.19 Low Time (T

10.15.20 T

Ratio in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55

H:TL

) in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54

) in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54

) in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54

) in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54

10.15.21 PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55

10.15.22 Pressure Support (P

10.15.23 Volume Support (V

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55

SUPP

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-56

T SUPP

10.15.24 % Supp in TC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-56

10.15.25 % Supp in PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-56

10.15.26 Rise Time% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-56

10.15.27 Expiratory Sensitivity (E

10.15.28 Disconnect Sensitivity (D

10.15.29 High Spontaneous Inspiratory Time Limit (

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-57

SENS

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-57

SENS

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-58

I SPONT

10.15.30 Humidification Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-58

10.15.31 Humidifier 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

x Operator's Manual

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

11.4 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

11.5 Interface Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

11.6 Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

11.7 Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

11.7.1 Ranges and Resolutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-7

11.8 Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-25

11.9 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-32

11.10 Essential Performance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-32

A BiLevel 2.0

A.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

A.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

A.3 Safety Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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-5

A.9 Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6

A.9.1 Synchrony in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-6

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 Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

B.4 Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

B.5 Setting Up Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

B.6 When Leak Sync is Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

B.6.1 Adjusting Disconnect Sensitivity (D

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-4

SENS

B.6.2 Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-5

Operator's Manual xi

B.7 Technical Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6

B.7.1 Inspired Tidal Volume (V B.7.2 Exhaled Tidal Volume (V

) Accuracy During Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6

) Accuracy During Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7

B.7.3 %LEAK Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-7

B.7.4 CIRCUIT DISCONNECT Alarm During Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-7

C PAV™+

C.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

C.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

C.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

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-6

C.4.6 PAV+ Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-7

C.4.7 Monitored Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-7

C.4.8 PAV+ Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-8

C.5 Ventilator Settings/Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8

C.5.1 Specified Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-8

C.5.2 Graphics Displays in PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-9

C.5.3 WOB Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-10

C.5.4 Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-11

C.5.5 Protection Against Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-15

D NeoMode 2.0

D.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

D.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

D.3 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

D.4 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

D.5 Neonatal Door and Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2

D.6 How to Empty the Condensate Vial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4

D.7 How to Connect the Breathing Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5

D.8 Ventilation Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7

D.8.1 Predicted Body Weight (PBW) vs. Patient Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7

D.8.2 Elevate O

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-8

D.8.3 CPAP Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-8

D.8.4 Entering CPAP From Other Ventilation Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-9

D.8.5 Exiting CPAP Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-9

D.8.6 Compliance Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10

D.8.7 Settings, Alarms, and Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10

xii Operator's Manual

E Proximal Flow

E.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1

E.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1

E.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1

E.4 Proximal Flow Option Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

E.4.1 Proximal Flow Option Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4

E.5 Hardware Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4

E.6 On-screen Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

E.7 Sensor Calibration and Sensor Line Purging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6

E.8 SST Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7

E.8.1 Attaching the Proximal Flow Sensor for SST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-8

E.9 Disabling/Enabling the Proximal Flow Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-9

E.10 Using the Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-10

E.10.1 How to Perform a Manual Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-12

E.11 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-12

E.12 Ranges, Resolutions, and Accuracies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-13

E.12.1 Proximal Flow Sensor Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-13

E.13 Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-14

F Trending

F.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1

F.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1

F.3 Safety Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1

F.4 Trending Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1

F.5 Setting Up Trending . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-2

F.6 Trend Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3

F.7 Viewing Trended Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-6

F.7.1 Time Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-7

F.7.2 Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-7

F.8 Trending Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-10

F.8.1 Adult and Pediatric Trending Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-11

F.8.2 Neonatal Trending Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-11

F.9 Data Gaps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-12

Glossary

Index

Operator's Manual xiii

Page Left Intentionally Blank

xiv Operator's Manual

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Table2-6. GUI Visual Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

Table2-7. Symbols and Abbreviations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35

Table3-1. Patient Types and PBW Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

Table3-2. Ventilator Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32

Table3-3. SST Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-44

Table3-4. Humidifier Volumes—Adult and Pediatric Patients. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-45

Table3-5. Humidifier Volumes—Neonatal Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-45

Table3-6. SST Test Step Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-46

Table3-7. Overall SST Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-46

Table3-8. EST Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-53

Table3-9. EST Test Step Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55

Table3-10. Overall EST Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

Table4-4. Invasive to NIV on Same Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Table4-5. NIV to Invasive on Same Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

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 Priority. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26

Table7-1. Operator Preventive Maintenance Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Table7-2. Surface Cleaning Agents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Table7-3. Component Cleaning Agents and Disinfection Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Table7-4. Service Preventive Maintenance Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15

Table9-1. Accessories and Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Table10-1. Compliance Volume Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13

Table10-2. Maximum Pressure Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-17

Operator’s Manual xv

List of Tables

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 V

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. Illustrated Modes and Breath Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-50

Table10-10. Safety PCV Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-60

Table10-11. Inspiratory Backup Ventilation Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62

Table11-1. Performance Verification Equipment Uncertainty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Table11-2. Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Table11-3. Pneumatic Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Table11-4. Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Table11-5. Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Table11-6. RS-232 Pinout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Table11-7. Nurse Call Pinout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Table11-8. Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Table11-9. Ventilator Settings Range and Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Table11-10. Alarm Settings Range and Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14

Table11-11. Patient Data Range and Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-17

Table11-12. Delivery Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23

Table11-13. Monitoring (Patient Data) Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23

Table11-14. Computed Value Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-24

Table11-15. Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-26

Table11-16. Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-26

Table11-17. Immunity to Proximity Fields RF Wireless Communications Equipment. . . . . . . . . . . . . . . . . . 11-29

Table11-18. AIM Standard Test Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-30

Table11-19. Recommended Separation Distances for RF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-31

Table11-20. Recommended Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-32

TableB-1. Maximum Leak Compensation Flow Based on Patient Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

TableB-2. D

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

SENS

TableC-1. Absolute limits for PAV+ Monitored Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7

TableC-2. PAV+ Work of Breathing Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-10

TableC-3. Default PBW-based Resistance Values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-19

TableD-1. Recommended Breathing Circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7

TableD-2. Allowable NeoMode Ventilator Settings and Ventilation Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7

TableD-3. Delivered Volume Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-11

TableD-4. Monitored Inspired Volume (V TableD-5. Monitored Exhaled Tidal Volume (V

TableE-1. Proximal Flow Option Patient Data Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6

TableE-2. Proximal Flow Option SST tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-8

TableE-3. Proximal Flow Sensor Volume Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-13

TableE-4. Proximal Flow Sensor Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-14

Based on Circuit Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-48

) Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-11

) Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-11

xvi Operator’s Manual

List of Tables

TableE-5. Proximal Flow Option Component Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-14

TableF-1. Trended Ventilator Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3

TableF-2. Trended Patient Data Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-4

TableF-3. Sampling Periods for Selected Time Scales. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-7

TableF-4. Events. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-8

Operator’s Manual xvii

Page Left Intentionally Blank

xviii Operator's Manual

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. Pendant-mount Ventilator Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Figure2-9. Ventilator Power Switch and AC Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

Figure2-10. Service Mode Button (TEST). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

Figure2-11. Sample Status Display During Normal Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26

Figure2-12. Pneumatic Diagram (Compressor Shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36

Figure2-13. Pneumatic Diagram—Compressor and Prox Flow Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38

Figure3-1. Example of Freestanding Ventilator Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Figure3-2. Example of Pendant-mounted Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Figure3-3. Power cord Retainer on BDU (without spacers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Figure3-4. Power Cord Retainer on BDU (with spacers). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Figure3-5. Connecting the Ventilator to the Gas Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Figure3-6. Adult/Pediatric Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Figure3-7. Installing the Neonatal Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Figure3-8. Drain Bag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Figure3-9. Connecting the Adult or Pediatric Patient Circuit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Figure3-10. Connecting the Neonatal Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Figure3-11. Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18

Figure3-12. Proper Battery Orientation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

Figure3-13. Battery Compartment Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

Figure3-14. Flex Arm Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

Figure3-15. Bracket Installation on Rail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26

Figure3-16. Humidifier Installation to Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27

Figure3-17. Service Mode Button (TEST). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31

Figure3-18. Flow Sensor Requires Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-48

Figure3-19. Calibrate The Flow Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-48

Figure3-20. Waiting to Begin Calibration and Calibration Test Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49

Figure3-21. Successful Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49

Figure3-22. SST Prompts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-50

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

Operator’s Manual xix

List of Figures

Figure4-9. Vent Setup Button—“NIV” Indicating NIV Ventilation Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Figure4-10.

Figure4-11. Default NIV Alarm Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Figure4-12. RM in Menu Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Figure4-13. Respiratory Maneuver Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

Figure4-14. More Settings Screen with O

Figure5-1. Incompatible USB Device Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Figure5-2. Comm Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Figure5-3. Port Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Figure6-1. Alarm Message Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Figure7-1. EVQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

Figure7-2. EVQ Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Figure7-3. EVQ Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Figure7-4. Exhalation Valve Diaphragm Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Figure7-5. Exhalation Filter Seal Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Figure7-6. Pressure Sensor Filter Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Figure7-7. Immersion Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11

Figure7-8. EVQ Reprocessing Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12

Figure7-9. Installing the Pressure Sensor Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13

Figure7-10. Installing the Exhalation Filter Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13

Figure7-11. Installing the Diaphragm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14

Figure7-12. Installing the EVQ. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15

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

Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

I SPONT

Sensor Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

xx Operator’s Manual

List of Figures

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 P

FigureA-2. BiLevel Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

FigureA-3. BiLevel Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

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 P

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-5

FigureB-4. Circuit Disconnect During VC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7

FigureC-1. Ventilator Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4

FigureC-2. Graphics displays in PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-11

FigureC-3. Use of Default Lung Resistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-18

FigureD-1. Installing the Neonatal Filter and Door. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

FigureD-2. How to Connect the Breathing Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-6

FigureD-3. CPAP Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-9

FigureE-1. Proximal Flow Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4

FigureE-2. Sample GUI screen Showing Proximal Flow Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

FigureE-3. Message During Autozero and Purge Processes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7

FigureE-4. Attaching Proximal Flow Sensor to Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-9

FigureE-5. Enabling/Disabling the Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-10

FigureE-6. Attaching the Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-11

FigureE-7. Manual Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-12

FigureE-8. Alarm Message—Prox Inoperative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-13

FigureF-1. Accessing Trending via the Menu Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8

Operator’s Manual xxi

Page Left Intentionally Blank

xxii Operator's Manual

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. The latest version of this manual is available on the Internet at:

www.medtronic.com/covidien/support/product-manuals

Click Acute Care Ventilation > PuritanBennett™ 980 Ventilator, then follow the prompts to select the desired manual.

To order an additional copy of this manual, contact Covidien Customer Service or your local representative.

1.1.1 Related Documents

Documentation is available online at the URL above. Covidien makes available all appropriate information relevant to use and service of the ventilator. 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 ventilator.

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

1-1

Introduction

Serial number interpretation

•

• Information regarding electromagnetic susceptibility

1.2 Global Symbol Definitions

Table1-1. 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

Serial number

Part number

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 standards for use in the U.S. and Canada.

1-2 Operator's Manual

Safety Information

Table1-1.Shipping Carton Symbols and Descriptions (Continued)

Symbol Description

U.S. federal law restricts this device to 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 product.

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, 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 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

 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 of the ventilator’s openings or ports.

 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. See To adjust

alarm volume, page 3-37 for instructions on alarm volume adjustment.

Safety Information

 WARNING:

Do not pause, 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 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, 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:

Although the 980 Series Ventilator meets the standards listed in Chapter 11, the internal lithiumion battery of the device is considered to be Dangerous Goods (DG) Class 9 - Miscellaneous, when transported in commerce. The 980 Series Ventilator and 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

 WARNING:

To avoid the risk of ventilator malfunction, operate the ventilator in an environment that meets specifications. See Table11-8.on page 11-6.

 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. See To run SST, page 3-43.

 WARNING:

Check for leaks in the ventilator breathing system by running SST prior to ventilating a patient.

Safety Information

 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 Table11-12., Table11-13., and Table11-14.are applicable only under specified operating conditions. See Table11-8.on page 11-6 for environmental specifications. 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 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 or removing accessories from the ventilator breathing system (VBS) can change the pressure gradient across the 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. See Table11-4.on page 11-3. If adding accessories to or removing accessories from the VBS, always run SST to establish circuit compliance and resistance prior to ventilating the patient.

1-8 Operator's Manual

 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

%, 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.

Safety Information

 WARNING:

Always use filters designed for use with the Puritan Bennett™ 980 Series Ventilator. Do not use filters designed for use with other ventilators. See Table9-1.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 606011-1. 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 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. See Table11-8.on page 11-6 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

1-10 Operator's Manual

sterilizing the ventilator and its components. Use all cleaning solutions and products with caution. Follow manufacturer’s instructions for individual cleaning solutions. See Chapter 7.

 WARNING:

To prevent infection and contamination, always ensure inspiratory and exhalation bacteria filters are installed before ventilating the patient.

 WARNING:

Never attempt to reuse single-use components or accessories. Doing so increases risk of crosscontamination and reprocessing of single-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.

Safety Information

 WARNING:

Follow preventive maintenance according to specified intervals listed in these tables. See

Table7-1.on page 7-2 and Table7-4.on page 7-15.

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. See Table7-2.on page 7-4.

 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. See Table7-2.on page 7-4 for approved cleaning agents.

 Caution:

Clean the compressor inlet filter according to the interval listed in Chapter 7. See Table7-1.on page 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:

To prevent possible damage to electronic circuitry, do not connect the GUI to the BDU while power is applied.

 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:

Federal law (U.S.A.) restricts the sale of this device except by or on the order of a physician.

 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.

1-12 Operator's Manual

 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 O

delivered for 2 minutes, page 3-36.

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 representative. The Puritan Bennett™ 980 Series Ventilator Service Manual includes information necessary to service or repair the ventilator when used by qualified service personnel.

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.

Obtaining Technical Assistance

control. See To adjust the amount of elevated O2

The ventilator’s configuration is available by touching the wrench icon on the GUI screen, then touching the Options tab. Have this information available whenever requesting technical assistance.

Manufacturer’s address

Covidien 2101 Faraday Ave. Carlsbad, CA 92008 Phone: 1 800 255 6774 option 4 Email: VentTechSupport@covidien.com

For online technical support, visit the SolvIT

USA

Center Knowledge Base at

solvitcenter.puritanbennett.com/ and follow the prompts.

The SolvIT Center provides answers to frequently asked questions about the ventilator system and other Puritan Bennett products 24 hours a day, 7 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.

Operator's Manual 1-13

Introduction

 Note:

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

Touch the item in question for a period of at least 0.5 second, or drag the help icon (the question mark icon appearing 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.

Touch “more” on the dialog to display an expanded description.

Touch “close” to close the dialog, or let it fade away after 5 seconds.

Dragging the help icon causes the tooltip to display in its unexpanded state.

 Note:

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, Proximal Flow, and Trending functions.

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 10 digits, in the following format:

35ZYYXXXXX

where

• 35 signifies the unit was manufactured in Galway, Ireland.

1-14 Operator's Manual

Manufacturer

Z represents the product code (B = breath delivery unit, G = GUI, C = DC 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 locations on product options.

1.7 Manufacturer

Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.

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, two-way radios, 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 Series Ventilator requires special precautions to be taken regarding electromagnetic compatibility (EMC) and must be installed and put into service according to the EMC information provided in Chapter 11.

Operator's Manual 1-15

Introduction

Page Left Intentionally Blank

1-16 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.

• Items shown in bold font are physical hardware features (e.g., to patient port, exhaust port)

• Alarms are shown in ALL CAPITAL letters.

Communication between the ventilator’s graphical user interface (GUI) and the breath deliv- ery unit (BDU) occurs continuously via independent central processing units (CPUs).

See Figure2-12.on page 2-36 and Figure2-13.on page 2-38 and their associated reference designators 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 accumulator 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 exhalation 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 (P-Trig) or flow triggering ( decreases and the inspiratory pressure transducer (PI) monitors this pressure decrease. When the pressure drops to at least the value of the pressure sensitivity (P

delivers a breath. During flow triggering, the difference between inspiratory and expiratory

V-Trig). During pressure triggering, as the patient inhales, the airway pressure

) setting, the ventilator

SENS

2-1

Product Overview

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 (

breath. If the patient is not inhaling, any difference between delivered flow and expiratory flow is due to flow sensor inaccuracy or leaks in the ventilator breathing circuit. To compensate for leaks, which can cause autotriggering, the clinician can increase the

 Note:

Leak Sync is a software function that is enabled by the clinician. Details on its operation are provided in Appendix B.

A backup pressure triggering threshold of 2 cmH2O is also in effect. This provides enough pressure 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 expiratory phase if the expiratory pressure measurement (P

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 (if able to do so) through the valve.

), the ventilator delivers a

SENS

setting or enable Leak Sync.

SENS

) equals or exceeds the operator-set high

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-controlled breaths from 2 mL to 315 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 mandatory volume-controlled breaths from 2 mL to 2500 mL.

To ventilate neonatal patients on the Pediatric–Adult or Universal models, the NeoMode 2.0 software option is required. For details regarding the NeoMode 2.0 software option, see Appendix D.

The estimated service life of the ventilator is approximately 10 years, provided the preventive maintenance schedule stated in the Puritan Bennett™ 980 Series Ventilator Service Manual is followed; however, service life of individual units may vary.

2-2 Operator's Manual

Indications for Use

The ventilator’s IEC 60601-1/EN 60601-1 classification is:

• 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)

See Table2-3.on page 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, respectively, generate the breathing parameters.

2.3 Indications for Use

The Puritan Bennett™ 980 Series Ventilator 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-hospital 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 non-invasively, 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 operating rooms, special procedure areas, intensive and

critical care areas within the hospital and in hospital-type facilities. Hospital-type facilities include 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

 Note:

Federal law (U.S.A) restricts the sale of this device except by or on the order of a physician.

2.4 Contraindications

Do not operate the ventilator in a magnetic resonance imaging (MRI) environment.

2.5 Components List

 Note:

The ventilator has no components made of natural rubber 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 packing list shown in Table2-1. 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/condensate vial

2 Gas hoses (air and oxygen)

1 Standard caster base

1 DC compressor (optional)

1 Power cord

1 Operator’s manual CD

2-4 Operator's Manual

Quantity Item

1 Puritan Bennett™ 980 Series Ventilator Installation Instructions

1 Flex arm

1 Drain bag

1 Gold standard circuit (for running EST)

2.6

Product Views

2.6.1 GUI Front View

Product Views

Table2-1.Typical Packing List (Continued)

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

Operator's Manual 2-5

Audio paused1 key

Product Overview

2.6.2

GUI Rear View

5 Rotary encoder (knob)

1 The terms “audio paused” and “alarm silence“ are interchangeable.

Figure2-2.GUI Rear View

See Table2-4.on page 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

2.6.3 BDU Front View

Product Views

Figure2-3.BDU Front View

1 Power switch 5 Condensate vial

2 AC power indicator 6 Status display

3 Exhalation filter latch 7 Internal inspiratory filter

4 Exhalation filter 8 Option connector panel door

Operator's Manual 2-7

Product Overview

BDU Rear View

2.6.4

Table2-2.BDU Front Label Symbols and Descriptions

Symbol Description

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 DC compressor base (if the DC compres-

sor is installed). If no compressor is present, the standard base is included.

2 Air inlet 6 Remote alarm port

3 Oxygen inlet 7 Cylinder mount (optional)

4 Labels indicating installed software

options

5 Service mode button

Software option labels are applied to the grid located on the back of the ventilator, as shown in

Figure2-4.(item 4) and Figure2-5.(item 1).

Figure2-5.Installed Software Options

Table2-3.lists the symbols and descriptions found on the BDU or base labels.

Table2-3.BDU Rear Label or Panel Symbols and Descriptions

Symbol Description

U.S. federal law restricts this device to 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 combustibility.

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 10°C to 40°C (50°F to 104°F).

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.

Unsafe to use the ventilator in magnetic resonance imaging environments.

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).

2-10 Operator's Manual

Table2-3.BDU Rear Label or Panel Symbols and Descriptions (Continued)

Symbol Description

Service port (at rear of ventilator).

Service mode button (at rear of ventilator).

Remote alarm port (at rear of ventilator).

Ethernet connector (at rear of ventilator).

Product Views

Serial port (at rear of ventilator).

Table2-4.Common Symbols Found on GUI or BDU Labels

Symbol Description

Do Not Push—Do not push on the GUI

Manufacturer—Name of the ventilator manufacturer.

Serial number.

Manufacture date—The manufacture date is contained in the serial number. See Manufacture Date (1.6) on page 1-14 for details regarding interpretation of the serial number.

WEEE—Proper waste disposal. Follow local governing ordinances regarding 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

Figure2-7.Ventilator Left Side View

Mounting Configurations

2.7

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 movement. The ventilator system may also be purchased in a pendant-mount configuration, as shown in Figure2-8.Contact your local representative for more information.

Operator's Manual 2-13

Product Overview

Figure2-8.Pendant-mount Ventilator Configuration

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 representation of battery charge levels. See Table2-9.on page 2-27 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. See Using Battery Power, page 3-

2.9 Graphical User Interface

There are two displays on the ventilator—the primary display (GUI) and the status display.

2.9.1 Primary Display

The GUI incorporates a 15 inch display that rotates throughout a 170° angle 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 ventilator’s primary display. The GUI’s keys activate other ventilator functions including screen brightness, display lock, alarm volume, manual inspiration, inspiratory pause, expiratory pause, alarm reset, and audio paused.

2-14 Operator's Manual

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 in Table2-5.

Table2-5.GUI Control Keys

Key symbol Description

GUI Controls and Indicators

Display brightness 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 ventilator (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.

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 (P

breath stacking, a manual inspiration is not delivered during inspiration or during the restricted phase of exhalation. See Manual Inspiration (10.7.5) on page 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.

) to high pressure (PH) (or vice versa). To avoid

Operator's Manual 2-15

Product Overview

Table2-5.GUI Control Keys (Continued)

Key symbol Description

Inspiratory pause key—Initiates an inspiratory pause maneuver, which closes the inspiratory and exhalation valves and extends the inspiratory phase of a mandatory breath for the purposes of measuring end inspiratory pressure (P

pressure (P

Expiratory pause key—Initiates an expiratory pause maneuver, which extends the expiratory phase of the current breath to measure total PEEP (PEEP

Alarm reset key—Clears active alarms or resets high-priority alarms and cancels an active audio paused interval. 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.

), static compliance (C

), and static resistance (R

STAT

) for calculation of plateau

I END

STAT

TOT

GUI Touch Screen Reset

2.10.2

On rare occasions, the GUI touch screen may become unresponsive. If you observe an unresponsive 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

2. Touch the display lock key again. Doing so displays a progress bar below the locked padlock icon, after

Alternatively, ensure that a patient is not connected to the ventilator and power cycle the ventilator.

 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.

screen and the display lock key illuminates.

which time the locked icon will “unlock,” indicating a successful GUI touch screen reset.

2.10.3 Visual Indicators

Table2-6.shows the GUI’s visual indicators. See Figure4-1.on page 4-3 for area names.

2-16 Operator's Manual

GUI Controls and Indicators

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.

Pediatric patient circuit indicator. Indicates pediatric circuit type tested during SST, and in use. Appears above the Vent Setup button.

Manual Event

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. See Figure4-

1. on page 4-3. Touch this icon to dismiss all open

dialogs on the GUI screen. The display resumes showing the ventilator waveforms.

This text appears below the Home icon. Touching this text causes the manual event screen to appear, where a variety of events can be recorded for viewing in the Trending layout. See Appendix F for more information about events.

Alarms icon. A constant access icon. See Figure4-

1. on page 4-3.Touch this icon to display the alarm

settings screen, which allows alarm limits to be changed.

Logs icon. A constant access icon. See Figure4-1.on page 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.

Operator's Manual 2-17

Product Overview

Table2-6.GUI Visual Indicators (Continued)

Symbol

Description

Elevate O

control. A constant access icon. See Fig-

ure4-1.on page 4-3. Touch this icon to temporarily

increase the delivered oxygen concentration by the percent displayed in the Elevate O2 dialog. The ven-

tilator will deliver the elevated O 2 minutes and then return the O the set O

% value.

For the 2-minute period, the Elevate O

concentration for

concentration to

concentra-

tion can be set to result in any value between 22% and 100% O

2-minute interval. The Elevate O

delivery. Touching “Extend” restarts the

function can be

terminated prior to completion of the 2-minute interval by touching Stop. Any time the Elevate O

control is activated, an entry is made to the patient data log.

Screen capture icon. A constant access icon. See

Figure4-1.on page 4-3. Touch this icon to capture

the image displayed on the GUI screen. See

To capture GUI screens, page 5-2 to read the complete

procedure for capturing screen images.

Help icon. A constant access icon. See Figure4-1.on page 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. See Figure4-

1. on page 4-3. Touch this icon to display the config-

ure screen. Tabs with SST results, options, Comm setup, and date/ time change are displayed.

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 waveform 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.

2-18 Operator's Manual

Table2-6.GUI Visual Indicators (Continued)

Symbol Description

Restore waveform icon. Restores waveform to its original size. Located at the upper right of the maximized 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. See Figure4-2.on page 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. See Figure4-2.on page 4-4.

Low priority alarm icon (appears on alarm banner).

Medium priority alarm icon (appears on alarm banner).

GUI Controls and Indicators

2.10.4

On-screen Symbols and Abbreviations

Touch an on-screen symbol briefly (0.5 second) to display a tooltip on the GUI screen. The tooltip contains 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 5 seconds if left alone. Expanding the tooltip dialog prevents the tooltip from timing out. Touching outside the tooltip causes the dialog to close.

Table2-7.summarizes the ventilator’s symbols and abbreviations.

 Note:

Table2-7.is subject to change.

High priority alarm icon (appears on alarm banner).

Audio paused symbol. The audio paused symbol appears together with a 2-minute countdown timer in the constant access area when the audio paused key is pressed. See Figure4-1. on page 4-3.

Table2-7.Symbols and Abbreviations

Symbol or abbreviation Definition

SENS

Operator's Manual 2-19

Apnea interval

Disconnect sensitivity

Product Overview

Table2-7.Symbols and Abbreviations (Continued)

Symbol or abbreviation Definition

DYN

Dynamic compliance

Dynamic resistance

EEF End expiratory flow

I END

End inspiratory pressure

LEAK Exhalation leak

CIRC

LEAK

Exhalation leak at PEEP (Leak Sync enabled) as measured by

Monitored total circuit pressure

the proximal flow sensor

TE MAND

E TOT

E SPONT

TE SPONT

SENS

Exhaled mandatory tidal volume

Exhaled minute volume

Exhaled spontaneous minute volume

Exhaled spontaneous tidal volume

Exhaled tidal volume

Expiratory sensitivity

Expiratory time

Flow pattern (ramp)

Flow pattern (square)

CIRC

SENS

Monitored total inspiratory and expiratory flow

Flow sensitivity

V-Trig Flow triggering

Monitored inspiratory and expiratory flow measured at the

proximal airway

Monitored circuit pressure throughout the breath cycle mea-

High pressure setting (in BiLevel)

sured at the proximal airway

H:TL

High pressure time to low pressure time ratio (in BiLevel)

High pressure time (in BiLevel)

I:E Inspiratory time to expiratory time (I:E)

/C Inspiration compliance ratio

LEAK

Inspiratory leak

2-20 Operator's Manual

Table2-7.Symbols and Abbreviations (Continued)

Symbol or abbreviation Definition

GUI Controls and Indicators

3Tau

PEEP

MEAN

I PAV

Inspired tidal volume (when Leak Sync is enabled)

Inspiratory time

Inspiratory time constant

Inspiratory pressure

Inspired tidal volume

Intrinsic PEEP (auto PEEP)

PAV-based intrinsic PEEP

Low pressure setting (in BiLevel)

Low pressure time (in BiLevel)

Mean circuit pressure

NIF Negative inspiratory force

% Oxygen percentage

0.1

PAV

Airway occlusion pressure at 100 ms

PAV-based lung compliance

PAV-based lung elastance

% Supp Percent support setting for tube compensation and PAV+

WOB

PAV

TOT

PAV-based work of breathing of patient and ventilator during

PAV-based patient resistance

PAV-based total airway resistance

inspiration

PEAK

Peak circuit pressure

PEF Peak expiratory flow

MAX

Peak inspiratory flow

PSF Peak spontaneous flow

PEEP Set or monitored positive end expiratory pressure

%Leak Percent leak

COMP

SENS

Plateau pressure

Plateau time

Compensation pressure

Pressure sensitivity

Operator's Manual 2-21

Product Overview

Table2-7.Symbols and Abbreviations (Continued)

Symbol or abbreviation Definition

SUPP

P-Trig Pressure triggering

TIY

TEY

TI MANDY

TI SPONTY

TLY

f Respiratory rate or apnea respiratory rate

f/V

I SPONT

I/TTOT

STAT

Proximal mandatory inspired tidal volume

Proximal spontaneous inspired tidal volume

Proximal inspired tidal volume with Leak Sync enabled

Spontaneous rapid/shallow breathing index

Pressure support level

Proximal inspired tidal volume

Proximal exhaled tidal volume

Rise time percent

Spontaneous inspiratory time

Spontaneous inspiratory time ratio

Static compliance

Static resistance

Audible Indicators

2.10.5

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 pauses alarms for the 2-minute audio paused period.

T CIRC

T Y

PEEP

TOT

VC Vital capacity

VS Volume support

Monitored total inspiratory and expiratory volumes

Monitored Inspiratory and expiratory patient volumes mea-

sured throughout the breath cycle measured at the proximal

Total respiratory rate (monitored)

Tidal volume

airway

Total PEEP

2-22 Operator's Manual

Caregivers may choose to pause alarms by pressing the audio paused key. A 2-minute countdown timer appears on the GUI during the audio paused interval. Cancel the audio paused function by touching Cancel.

Click each icon in Table2-8.to listen to a sample of the corresponding tones:

 Note:

To hear the tones, Adobe Reader version 10 or higher must be installed on your computer.

Get Adobe Reader, free.

Breath Delivery Unit

Table2-8.GUI Audible Indicator Functions

Function Description

Low priority alarm tone A series of two tones. Sounds when a low priority

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 settings. 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. See Figure2-1.on page

2-5. The keys activate other ventilator functions. See Table2-5.on page 2-15.

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

Figure2-9.Ventilator Power Switch and AC Indicator

1 AC power indicator 2 On/Off switch

On/Off switch—Lift the switch cover and turn the ventilator on or off.

•

• 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. See Figure2-10., item 1.

2-24 Operator's Manual

Figure2-10.Service Mode Button (TEST)

Breath Delivery Unit

 Note:

The Covidien splash screen shows the Covidien logo and appears momentarily as a banner on the status display. See Table2-9.for an image of the splash screen.

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. See Typical Status Display Indicators and Messages, page 2-27 for a description of the status display indicators and symbols. See the next section for a summary of the information appearing on the status display.

Status Display

The status display is a separate display located on the BDU. See Figure2-3., item 6 on page 2-7. 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)

1 Service mode button

• 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, 2P

• 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.

Figure2-11.shows a sample of the status display during normal ventilation (compressor option

not installed).

values

alarm setting and current P

PEAK

Figure2-11.Sample Status Display During Normal Ventilation

PEAK

and PEEP

1 Primary and extended battery status (pres-

ence or absence).

2 Alarm volume setting 7 Measured inspiratory pressure (changes as

3 Gas connection status 8 Selected pressure units

4 Power status 9 Measured PEEP

2-26 Operator's Manual

alarm setting

PEAK

pressure changes)

5 Measured peak circuit pressure (updated

at the end of the current breath)

During Service mode the status display shows:

• Ventilator serial number

• 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

See Table2-9. for status display possibilities.

Typical Status Display Indicators and Messages

Breath Delivery Unit

 Note:

Status display images are shown without the optional DC compressor installed.

Table2-9.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 ventilator to enter Service mode.

POST failure. This image appears if a POST error occurs at ventilator startup, 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 installation 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 P

and PEEP values.

PEAK

Stand-By state. The status display appears as shown when the ventilator is in Stand-By state.

2-28 Operator's Manual

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. The percentage indicator shows 100%.

Battery charging/discharging. Identifies that the ventilator’s primary battery is charging or discharging, and provides its relative capacity. If an extended battery is installed, the image shows a similar representation in the extended battery location (left-most receptacle).

Breath Delivery Unit

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 insufficient AC power to operate the ventilator. Ventilator is operating on battery power with greater than 10 minutes of capacity remaining. Note the appearance of the battery icon.

Low battery. Identifies that the ventilator’s primary battery (right-most receptacle) is discharging and there are10 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 receptacle).

Operator's Manual 2-29

Product Overview

Table2-9.Status Display Indicators and Descriptions (Continued)

Status display indicator or message Meaning

Critically low battery. Identifies that the ventilator’s primary battery has less than 5 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.

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 batter or connect ventilator to AC power.

Battery inoperative. This image appears on the status display when a battery fault renders the battery inoperative.

Battery not installed. This image appears when there is no primary battery installed, and renders ventilator inoperative. This image displays when the primary battery is removed during ventilator operation.

2-30 Operator's Manual

Table2-9.Status Display Indicators and Descriptions (Continued)

Status display indicator or message Meaning

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 countdown timer lasts for approximately 30 s.

GUI failure. Indicates a loss of communication between the BDU and the GUI that cannot be recovered 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 ventilator 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 monitoring indicators (e.g., oxygen saturation, heart rate, blood pressure, etc.)

• Transfer the patient to an alternate source of ventilation consistent with your institution’s protocol.

Breath Delivery Unit

Ventilator inoperative (vent inop). Indicates the ventilator 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. See Safety Valve Open (SVO) (4.11.6) on page

4-32 for more information on the SVO state.

Operator's Manual 2-31

Product Overview

Table2-9.Status Display Indicators and Descriptions (Continued)

Status display indicator or message Meaning

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.

On AC power indicator. When this image appears on any status display indicator, indicates the ventilator is operating on AC power.

Status display appearance when the ventilator is breathing in Normal mode. Note the appearance of the AC power icon.

Air available indicator. When this image appears on any status display indicator, indicates the ventilator is connected to a pressurized air source.

available indicator. When this image appears on

any status display indicator, indicates the ventilator is connected to a pressurized O

source.

BDU Audible Indicators

The continuous tone alarm is the only audible indicator in the BDU, and is described in Table2-10.

2-32 Operator's Manual

Table2-10.BDU Audible Indicator Functions

Indicator Description

Additional Equipment

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 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 Appendix E.

• Standard interface connectors — USB, HDMI, and Ethernet connectors are provided. The USB con-

nector allows images 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 allows 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. See Port Use (5.5.1) on page 5-17 for more information. See To configure Comm ports, page 5-4 for information on serial-over-USB data transfer when configuring Comm ports for external devices.

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 breath delivery CPU PCBA. See 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 or compressor operation. See Table11-8.on page 11-6 for environmental specifications.

Operator's Manual 2-33

Product Overview

Special Features

2.13

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, see Appendix E for more information.

2.14 Color Definitions

Table2-11.provides a legend to interpret gas colors in the pneumatic diagrams shown in Figure2-12.and Figure2-13.

2-34 Operator's Manual

Table2-11.Color Legend

Pneumatic Diagrams

Color or

symbol

Pneumatic Diagrams

2.15

Description

High-pressure oxygen (NFPA 99 designation)

High-pressure air (NFPA 99 designation)

Mixed gases, including air

Atmosphere

Vacuum

Water

 Note:

Both the compressor and the Proximal Flow option are hardware options.

Figure2-12.and Figure2-13.illustrate the ventilator’s pneumatics with and without the optional

Proximal Flow option. The Proximal Flow option is only for use with neonatal patients.

Operator's Manual 2-35

Product Overview

Figure2-12.Pneumatic Diagram (Compressor Shown)

2-36 Operator's Manual

Pneumatic Diagrams

1 Pressure switch, mix accumulator (PS1) 28 Relief valve, compressor accumulator

(RVCA)

2 Solenoid valve, options supply (SOL2) 29 Solenoid valve, compressor unload (SOL7)

3 Pressure sensor, mix accumulator (P

4 Accumulator, mix (ACC

5 Tube, mix (T

) 32 Filter, compressor air (F7)

) 31 Heat exchanger, compressor (HE)

6 Proportional solenoid valve, patient gas

delivery (PSOL

)

) 30 Motor compressor (MC)

33 Dryer, compressor

7 Solenoid valve, BUV (SOL 3) 34 Filter, muffler (F6)

8 Safety valve (SV) 35 Check valve, compressor accumulator

)

(CV

9 Pressure sensor, safety valve (P

) 36 Pressure sensor, compressor accumulator

(PC)

10 Solenoid valve, inspiratory pressure sensor

37 Check valve, oxygen (CVO

)

autozero (SOL4)

11 Pressure sensor, inspiratory (P

) 38 Check valve, air (CV

)

Air

12 Pressure sensor, barometric (PA) 39 Proportional solenoid valve, oxygen

(PSOLO

13 Vial, exhalation condensate (ECV) 40 Flow sensor, air (FS

)

Air

14 Filter, exhalation (F4) 41 Proportional solenoid valve, air (PSOL

)

Air

15 Flow sensor assembly, exhalation valve 42 Pressure sensor, air gas inlet (P

)

Air

16 Exhalation valve (EV) 43 Restrictor, wall air bleed outlet (R1)

17 Filter, exhalation pressure line (F5) 44 Check valve, compressor air inlet (CV

18 Solenoid valve, exhalation pressure

45 Filter bowl assembly, air (WT2)

autozero (SOL 5)

19 Pressure sensor, exhalation (PE) 46 Filter element, air (F2)

20 Humidifier 47 Check valve, wall air inlet (CV

21 Filter, external bacteria (F

22 Filter, internal bacteria (F

23 Check valve, patient gas delivery (CV

) 48 Filter, oxygen impact (F1)

) 49 Filter element, oxygen (F3)

) 50 Pressure sensor, oxygen gas inlet (PO2)

24 Sensor, oxygen (OS) 51 Flow sensor, oxygen (FSO

)

WAir

)

25 Restrictor, breath delivery bypass (R2) 52 Restrictor, prox flow (R4)

26 Flow sensor, patient gas delivery (FS

) 53 Relief valve, mix accumulator (RVMA

CAir

)

Operator's Manual 2-37

Product Overview

27 Accumulator, compressor (ACCC) 54 Solenoid valve, mix accumulator purge

(SOL1)

Figure2-13.Pneumatic Diagram—Compressor and Prox Flow Options

 Note:

Items enclosed by the dotted line represent components internal to the ventilator.

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

)

PROX

5 Humidifier

9 Condensate vial, neonatal expiratory

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.

 WARNING:

Use only gas supply hoses approved by Covidien. Other hoses may be restrictive and may cause improper ventilator operation.

3-1

Installation

 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 qualified biomedical engineers per the schedule specified. See Table7-4.on page 7-15.

 Note:

U.S. federal law restricts this device to sale by or on the order of a physician.

3.3 Product Assembly

3.3.1 How to Assemble Ventilator Components

Ventilator setup, including a successful EST, should have already been completed by qualified service personnel. This manual does not include ventilator assembly instructions.

3.3.2 Product Power Sources

Using AC Power

The ventilator is normally AC-powered. See Connecting the Ventilator to AC Power (3.5.1) on page

3-5 to connect the ventilator to AC power.

Using Battery Power

 WARNING:

Use only Covidien 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. See Figure3-13.on page 3-20 to identify battery slots.

The ventilator’s primary battery must be installed by qualified service personnel (as it is shipped separately) before patient use. The ventilator will not complete power on self test (POST) if the battery is not present, and ventilation is prohibited. Ensure the battery is fully charged before placing the ventilator into service.

3-2 Operator's Manual

Product Assembly

The ventilator employs a battery backup system if AC power becomes unavailable or drops below approximately 90 volts. A new, fully charged battery provides at least 1 hour of power to the ventilator assuming ambient temperature of 20°C (68°F) to 25°C (77°F), PBW=70 kg, and at factory default ventilator settings.

The battery back-up systems for the ventilator and compressor contain one primary battery each. Backup power is supplied to the ventilator in the event of an AC power loss.

One extended battery receptacle is available for the ventilator and one extended battery receptacle is available for the compressor. If both primary and extended ventilator and compressor batteries are present, these batteries can power the ventilator and compressor for 2 hours (1 hour for the primary battery and 1 hour for the extended battery) under the environmental conditions described above. When using battery power, the ventilator and compressor operate from their extended batteries, if present, first and then switch to the primary batteries. The ventilator and compressor primary and extended batteries are charged whenever the ventilator is plugged into AC power (the ventilator does not have to be powered up). If the ventilator or compressor is operating on battery power, the status display shows which battery is in use and its charge level, and the remaining time the battery will operate before charging is required again.

Battery Charging

Batteries requiring charging are charged whenever the ventilator is connected to AC power, whether operating or not.

The ventilator and compressor charge their primary batteries first, then their extended batteries. The time required to charge a single battery (either primary or extended) is approximately 6 hours at room temperature whether the ventilator is turned off (but connected to AC power) or operating, but charging time can vary based on temperature or depletion state of the battery. The status display provides the batteries’ capacities.

Green LED bars located on the ends of both primary and extended batteries (if installed) scroll upwards indicating battery charging. A white LED bar represents the battery is in use and a round LED indicator illuminates red if there is a battery fault. When running on battery power, battery capacity is determined by the number of green LED bars illuminated. See Figure3-12.on page

3-19 to view the LEDs. See page 3-18 for information on interpreting the battery capacity. Green

LED bars do not scroll if the battery is not charging or is in use.

The compressor’s battery charging system (if a compressor is present) operates independently from the ventilator’s charging system and batteries are charged in parallel.

If a battery fault occurs, the fault is annunciated, charging of the faulty battery discontinues, but charging of any other non-faulty battery continues. A faulty battery will cause annunciation of the error and battery power will not be available from that battery.

The ventilator status display indicates the charge level of the installed batteries, the presence of one or more battery faults, and which battery is being charged.

The ventilator operates no differently when its batteries are charging than it does when the batteries are fully charged.

Operator's Manual 3-3

Installation

The ventilator continues operating as set when the ventilator switches from AC power to battery power and illuminates an indicator on the status display alerting the operator that the ventilator is now operating on battery power and AC POWER LOSS alarm annunciates. A medium priority alarm annunciates when the remaining run-time for the ventilator drops to 10 minutes and a high priority alarm annunciates when the remaining time drops to 5 minutes.

3.4 Product Placement

The ventilator is positioned standing on its casters next to the patient’s bedside, as shown in

Figure3-1., or if using a pendant-mounted configuration, Figure3-2.

Move the ventilator using the handle encircling the BDU and roll the ventilator to the desired location.

Figure3-1.Example of Freestanding Ventilator Placement

3-4 Operator's Manual

Figure3-2.Example of Pendant-mounted Ventilator

Product Connectivity

3.5

Product Connectivity

3.5.1 Connecting the Ventilator to AC Power

 Note:

Power outlet access and power cord position—Ensure that the power outlet used for the ventilator is easily accessible; disconnection from the outlet is the only way to completely remove power from the ventilator.

To connect the power cord to AC power

1. Plug the ventilator into a properly grounded power outlet rated for at least 15 A.

2. Verify the connection by checking the AC indicator below the power switch on the front of the BDU.

See Figure2-9.on page 2-24 for the power switch and AC indicator locations.

To connect the power cord to the ventilator

1. Remove the power cord retainer and connect the female end of the power cord to the ventilator’s

power cord receptacle. See Figure3-3.on page 3-6 and Figure3-4.on page 3-7.

2. Set hex nuts and spacers, if present, aside for reassembly.

3. Replace the power cord retainer, using the hex nuts and spacers removed during disassembly. See Fig-

ure3-3. on page 3-6 or Figure3-4. on page 3-7.



Operator's Manual 3-5

Note:

Your ventilator may have either combination of power cord and retainer.

Installation

Use the power cord hook located at the back of the ventilator for power cord storage.

 WARNING:

For proper ventilator operation, and to avoid the risk of electric shock, connect the ventilator to a grounded, hospital-grade, AC electrical outlet.

Figure3-3.Power cord Retainer on BDU (without spacers)

1 1/4 in. hex nuts 3 AC power cord

2 Power cord retainer

3-6 Operator's Manual

Figure3-4.Power Cord Retainer on BDU (with spacers)

Product Connectivity

1 1/4 in. hex nuts 3 AC power cord

2 Power cord retainer 4 Spacers

Connecting the Gas Supplies

3.5.2

The ventilator can be connected to hospital grade wall or bottled air and oxygen. See

Figure3-5.on page 3-8. Both air and O

599.8 kPa (35 psig and 87 psig) and the average flow requirement for both gases is 60 L/min at 280 kPa (40.61 psi). The transient will not exceed 200 L/min for ≥3 seconds.

supply pressure ranges must be between 241.3 kPa to

 WARNING:

Due to excessive restriction of the Air Liquide™, SIS, and Dräger™ hose assemblies, reduced ventilator performance levels may result when oxygen or air supply pressures <345 k Pa (50 psi) are employed.

Operator's Manual 3-7

Installation

Gas cross flow from one high pressure input port of one type of gas to another high pressure input port of a different gas will not exceed 100 mL/h under normal or single fault conditions. If, during a single fault condition, cross flow exceeds 100 mL/h, an audible alarm annunciates.

 WARNING:

To connect the gas sources

1. Connect the oxygen hose to the oxygen inlet fitting (item 1) as shown. Ensure use of a medical grade

2. Connect the air hose to the air inlet fitting (item 2) See Figure3-5.on page 3-8.

oxygen source.

Figure3-5.Connecting the Ventilator to the Gas Supplies

3-8 Operator's Manual

gas connection 2 Air gas connection

 WARNING:

To prevent a potential fire hazard and possible damage to the ventilator, ensure the connections to the gas supplies are clean and unlubricated, and there is no water in the supply gas. If water is suspected, use an external wall air water trap to prevent damage to the ventilator or its components.

The ventilator system can be purchased with the following gas inlet fittings for both air and O2: BOC, DISS, female, NIST, Air Liquide, SIS, and Dräger.

See Table9-1.on page 9-3 for part numbers of gas hoses.

3.5.3 Filter Installation

The ventilator is shipped with internal and external inspiratory filters. See Table9-1.on page 9-3 for the part numbers of exhalation filters. To prevent infection and contamination, both inspiratory and exhalation filters must be used with the ventilator.

 WARNING:

To reduce the risk of infection, always use the ventilator with inspiratory and exhalation bacteria filters.

Product Connectivity

 WARNING:

Do not attempt to use inspiratory or exhalation filters designed for use with ventilators other than the Puritan Bennett 980 Series Ventilator. See Table9-1.on page 9-3 for relevant part numbers.

 WARNING:

Refer to the filter’s instructions for use (IFU) for details such as cleaning requirements, filtration efficiency, proper filter usage, and maximum filter resistance, particularly when using aerosolized medications.

 Caution:

Ensure both inspiratory and exhalation filters are properly attached to the ventilator.

 Note:

Refer to the inspiratory filter IFU for information on proper use and handling of the filter.

To install the inspiratory filter

1. Attach the inspiratory filter to the to patient port.

2. Ensure the direction of flow arrow is pointing outward, toward the patient circuit’s inspiratory limb.

 Note:

Refer to the inspiratory filter IFU for information on proper use and handling of the filter.

Operator's Manual 3-9

Installation

 Note:

Refer to the exhalation filter IFU for information on proper use and handling of the filter and for emptying the condensate vial for adult and pediatric patients. See Appendix D for information on emptying the condensate vial when using neonatal exhalation filters.

 WARNING:

Do not reuse disposable inspiratory or exhalation filters, and dispose of the filters according to your institution’s policy for discarding contaminated waste.

To install the adult/pediatric exhalation filter

1. If necessary, remove the expiratory limb of the patient circuit from the exhalation filter.

2. Raise the exhalation filter latch to unlock (item 3).See Figure3-6.on page 3-11. This raises the exhala-

3. Open the exhalation filter door.

4. Remove the existing filter.

tion valve assembly and allows the filter door to swing away from the ventilator.

5. Insert the new filter by sliding the filter along the tracks in the door. Ensure the from patient port

aligns with the cutout in the door and points away from the ventilator.

6. Close the exhalation filter door.

7. Lower the exhalation filter latch to secure the filter.

 WARNING:

Do not operate the exhalation filter latch during patient ventilation. Opening the latch during ventilation will result in a patient disconnect condition and corresponding alarm.

 Note:

To prevent EVQ misalignment and potential damage, ensure there is an exhalation filter in place any time the ventilator is transported from one location to another.

3-10 Operator's Manual

Figure3-6.Adult/Pediatric Filter Installation

Product Connectivity

1 Condensate drain port cap 3 Exhalation filter latch

2 Condensate drain port 4 Exhalation filter door

To install the neonatal exhalation filter adapter door

1. If necessary, remove the expiratory limb of patient circuit from the exhalation filter.

2. Lift the exhalation filter latch. See Figure3-7.(item 3).

3. Remove the existing exhalation filter door by lifting it off of the pivot pins.

4. Fit neonatal adapter door onto the pivot pins.

Operator's Manual 3-11

Installation

Figure3-7.Installing the Neonatal Filter

1 Neonatal exhalation filter 3 Exhalation filter latch

2 Neonatal adapter door 4 Filter door pivot pin

 Note:

The condensate vial is removable for discarding accumulated liquid, by turning the vial clockwise to remove and counterclockwise to install.

To install the neonatal exhalation filter assembly

1. With the door still open, push the neonatal filter assembly straight up into the adapter.

2. Close the door.

3. Lower the exhalation filter latch.

4. Re-attach the expiratory limb of the patient circuit to the filter.

To use the drain bag

1. Remove the drain port cap from the exhalation filter condensate vial drain port.

2. Attach the drain bag tube to the condensate vial’s drain port.

3. Hang the drain bag on the holder located on the ventilator’s accessory rail, as shown in Figure3-8.on

page 3-13. See Table9-1.on page 9-3 for the part number of the drain bag holder.

3-12 Operator's Manual

Figure3-8.Drain Bag

Product Connectivity

3.5.4

Connecting the Patient Circuit

See Figure3-9.on page 3-15 or Figure3-10.on page 3-16 to connect the adult, pediatric, or neonatal patient circuits, respectively.

 WARNING:

Use patient circuits of the lowest compliance possible with the ventilator system to ensure optimal compliance compensation and to avoid reaching the compliance compensation limit. See Table3-

1. for circuit types corresponding with predicted body weight (PBW).

Operator's Manual 3-13

Installation

 Note:

Table3-1.Patient Types and PBW Values

Circuit type PBW in kg (lb) Allowed but not recommended

Neonatal 0.3 kg to 7.0 kg (0.66 lb to 15 lb) Not applicable

Pediatric 7.0 kg to 24 kg (15 lb to 53 lb) 3.5 kg to 6.9 kg and 25 kg to 35 kg

(7.7 lb to 15 lb and (55 lb to 77 lb)

Adult 25 kg to 150 kg (55 lb to 331 lb) 7.0 kg to 24 kg

(16 lb to 53 lb)

Refer to the patient circuit’s IFU for information on proper use and handling and care and maintenance of the circuit.

A list of breathing system components and accessories is provided. See Table9-1.on page 9-3. Use only Covidien components and accessories in the patient circuit.

Follow your institution’s protocol for safe disposal of the patient circuit.

Follow the patient circuit’s IFU for cleaning and disinfection information for reusable circuits.

Orient the patient circuit by hanging the patient circuit on the circuit management supports provided with the flex arm.

3-14 Operator's Manual

Figure3-9.Connecting the Adult or Pediatric Patient Circuit

Product Connectivity

1 Humidifier 6 From patient port

2 Inspiratory limb 7 Exhalation filter

3 Circuit wye 8 To patient port

4 Expiratory limb 9 Inspiratory filter

5 Condensate vial

Operator's Manual 3-15

Installation

Figure3-10.Connecting the Neonatal Patient Circuit

1 Humidifier 6 From patient port

2 Patient circuit inspiratory limb 7 Neonatal exhalation filter (installed in

adapter door)

3 Circuit wye 8 To patient port

4 Patient circuit expiratory limb 9 Inspiratory filter

5 Condensate vial

 WARNING:

Do not attempt to sterilize single-use circuits.

3-16 Operator's Manual

How to Install Accessories

3.6

3.6.1 Batteries

 WARNING:

Use only Covidien batteries. Using other manufacturer’s brands or remanufactured batteries could result in the batteries operating the ventilator for less than the specified amount of time or could cause a fire hazard.

 WARNING:

To reduce the risk of infection due to cross-contamination, using a damp cloth, disinfect the batteries with one of the solutions listed before installation and whenever transferring to or from another ventilator. During use, clean external surfaces of batteries as necessary. See Table7-2.on page 7-4. Do not spray disinfectant directly onto the battery or its connector.

 WARNING:

Although the Puritan Bennett 980 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. As such, the Puritan Bennett 980 Ventilator and 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.

How to Install Accessories

 WARNING:

To avoid the risk of fire, explosion, electric shock, or burns, do not short circuit, puncture, crush, heat above 60°C, incinerate, disassemble the battery, or immerse the battery in water.

 Caution:

Ensure that the batteries are oriented properly. See Figure3-12.on page 3-19.

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Installation

Figure3-11.Battery

1 Battery connector

Primary Batteries

The ventilator’s primary battery is located in the rearward battery receptacle on the right side of the BDU. The compressor’s primary battery is located in the rearward battery receptacle in the compressor base. See Figure3-13.on page 3-20. The primary battery may be “hot swapped,” that is it can be replaced while the ventilator is operating.

To install or replace the primary battery in the BDU or compressor

1. With the battery not installed in the ventilator, or if the ventilator is turned off and not connected to

AC power, check the charge level by pressing the charge level button on the battery and verifying the charge level LEDs illuminate. See Figure3-12.on page 3-19. for the location of the charge level button. Five green LED segments illuminate, indicating ≥90% battery capacity. From bottom to top, the first LED indicates ≥10% capacity, the second LED indicates ≥25% capacity, the third LED indicates≥50% capacity, and the fourth LED indicates ≥75% capacity. An illuminated red LED at the top of the battery indicates a battery fault. If no LEDs illuminate it means there is <10% battery capacity remaining.

2. If the charge level is sufficient, orient the battery as shown in Figure3-13.on page 3-20, face the front

of the ventilator and locate the battery compartments on the right side of the appropriate module. The

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How to Install Accessories

receptacle towards the rear of the ventilator houses the primary battery while the receptacle towards the front of the ventilator houses the extended battery.

3. The primary battery is fastened in place with a thumbscrew (item 3). Loosen the thumbscrew approx-

imately four to five turns to allow battery installation.

4. Insert the battery and push into its receptacle all the way until it clicks, indicating it is latched. The

battery will only fit into the slot one way.

Figure3-12.Proper Battery Orientation

1 White battery in-use LED 3 Green charge status LEDs

2 Red battery fault indicator 4 Charge level button

5. Tighten the thumbscrew to secure the battery and prevent the primary battery from being removed.

 Note:

Remove either primary battery by reversing the steps. After loosening the thumbscrew, slide the battery ejector to the left to eject the battery.

Operator's Manual 3-19

Installation

Figure3-13.Battery Compartment Locations

1 BDU extended battery receptacle and

ejector

2 BDU primary battery receptacle and

ejector

3 BDU and compressor primary battery

thumbscrews

4 Compressor primary battery receptacle

and ejector

5 Compressor extended battery receptacle

and ejector

6 BDU primary battery (positioned for instal-

lation)

Extended batteries

The extended battery receptacle is located forward of the primary battery. Like the primary battery, the extended battery may be hot swapped.

To install or remove an extended battery in either the BDU or compressor

1. Properly orient the battery as shown in Figure3-13.on page 3-20.

2. Push the battery into the forward receptacle in the BDU all the way until it clicks, indicating the battery

is latched.

3-20 Operator's Manual

 Note:

Remove the battery by sliding the battery ejector to the left. The battery ejects itself from its receptacle. There is no thumbscrew for extended batteries.

 Note:

See Battery Charging, page 3-3 for battery charging information when batteries are installed in the ventilator.

3.6.2 Battery Testing

To test the batteries

1. Push the battery charge level button located on the battery. A series of LEDs illuminates, indicating the

charge level of the battery. When the bottom LED is illuminated, there is≥10% of full battery capacity. The next LED illuminates when there is ≥25% capacity. the third lamp illuminates when there is ≥50% capacity available. The fourth LED illuminates when there is ≥75% capacity, and when the top LED is illuminated, it represents ≥90% capacity. See Figure3-12.on page 3-19 to view the battery test button and LEDs.

How to Install Accessories

3.6.3 Battery Performance Test Results

Performance testing on a sample of new batteries and batteries charged and discharged at least 1000 times was completed to demonstrate that the ventilator’s LOW BATTERY alarms remain effective. Testing demonstrated that the batteries have a minimum of 10 minutes time remaining from the activation of the low battery alarm and a minimum of 5 minutes time remaining from the critically low battery alarm until ventilator shutdown. See Table2-9.on page 2-27 for images of the Status Display during low battery and critically low battery conditions.

Performance testing on a sample of new batteries and batteries charged and discharged at least 1000 times was completed to demonstrate the expected run time of the ventilator on battery. This testing was performed for both typical ventilator settings and adult high demand ventilator settings.

The typical ventilator settings used were:

• Ventilator settings

– Assist/Control Ventilation with Volume Control (VC) mandatory type

– Tidal volume (V

– Peak flow (V

)=500 mL

)=30 L/min

MAX

– Respiratory rate (f)=20 1/min

– PEEP=8 cmH

Operator's Manual 3-21

Installation

Oxygen concentration (FiO2)=60%

–

– Flow trigger (V-Trig)=3 L/min

• Approximate respiratory monitored parameters during simulation

– Peak pressure (P

– Plateau pressure (P

– Exhaled tidal volume (V

– Total respiratory rate (R

– I:E ratio =1:2

– PEEP=8 cmH

– Exhaled minute volume (V

• Adult high-demand ventilator settings

– Assist/Control Ventilation with Pressure Control (PC) mandatory type

– Inspiratory pressure (P

– Inspiratory time (T

– Respiratory rate (f)=60 1/min

)=27 cmH2O

PEAK

) during manual inspiratory pause =23 cmH2O

)= 442 mL (BTPS)

)=20 1/min

TOT

O / Total PEEP (PEEP

)=8.84 L/min

E TOT

)=55 cmH2O

)=0.55 s

) during expiratory pause =8 cmH2O

TOT

– PEEP=35 cmH

– Oxygen concentration (FiO

– Flow trigger (V-Trig)=20 L/min

• Approximate respiratory monitored parameters during adult high-demand simulation

– Peak pressure (P

– Plateau pressure (P

– Exhaled tidal volume (V

– Total respiratory rate (R

– I:E ratio =1:1

– PEEP=39 cmH

)=60%

)=90 cmH2O

PEAK

) during manual inspiratory pause =79 cmH2O

)=900 mL (BTPS)

)=60 1/min

TOT

O / Total PEEP (PEEP

) during expiratory pause =49 cmH2O

TOT

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How to Install Accessories

Exhaled minute volume (V

–

E TOT

)=52 L/min

The run time does not vary significantly between typical and heavy load settings. The ventilator can be expected to run approximately 75 minutes at typical settings with new batteries. When running batteries nearing end of life (batteries with 1000 charge/discharge cycles were used for this data) the run time can be expected to be approximately 55 minutes.

3.6.4 Battery Life

Battery life for both primary and extended batteries is approximately 3 years. Actual battery life depends on the history of use and ambient conditions. As the batteries age with use, the time the ventilator will operate on battery power from a fully charged battery will decrease. Replace the battery every 3 years or sooner if battery operation time is insufficient for your usage.

3.6.5 Battery Disposal

The battery is considered electronic waste and must be disposed of according to local regulations. Follow local governing ordinances and recycling plans regarding disposal or recycling of the battery.

3.6.6 Flex Arm

Use the flex arm to support the patient circuit between the patient and the ventilator. See

Figure3-14.on page 3-24, which illustrates flex arm installation into the sockets provided.

Operator's Manual 3-23

Installation

Figure3-14.Flex Arm Installation

To attach or remove the flex arm

1. Locate the threaded inserts in the ventilator’s handle.

2. Fasten the flex arm into one of the inserts.

3. Hang the patient circuit using the circuit management supports included with the flex arm.

4. Remove the flex arm by first removing the patient circuit, then unfastening the flex arm from the

threaded fastener in the handle.

3.6.7 Humidifier

Use the humidifier to add heat and moisture to the inhaled gas. Connect the humidifier to a hospital grade electrical outlet. Choose the humidifier (type and volume appropriate for the patient).

3-24 Operator's Manual

Medtronic PuritanBennett980Ventilator_OperatorsManual_en_US_PT00109658A00 IRIS Medical Operating Microscope Adapter Operator Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Introduction

2 Product Overview

3 Installation