980 Series Operators Manual Rev A

Table of Contents 1

Introduction

1.1

1.5 1.6 1.7 1.8

Overview...1-1 Related Documents... 1-1 Global Symbol Definitions...1-2 Safety Information...1-3 Safety Symbol Definitions... 1-3 Warnings Regarding Fire Hazards... 1-4 General Warnings... 1-5 Warnings Regarding Environment of Use... 1-7 Warnings Before Using Equipment... 1-8 Warnings Regarding Electrical Power... 1-9 Warnings Regarding Ventilator Settings... 1-9 Warnings Regarding Hoses, Tubing, and Accessories... 1-10 Warnings Regarding Gas Sources... 1-11 Warnings Regarding Infection Control... 1-12 Warnings Regarding Ventilator Maintenance... 1-13 Cautions... 1-13 Notes... 1-15 Obtaining Technical Assistance... 1-15 Technical Services... 1-15 On-screen Help... 1-16 Warranty Information... 1-17 Manufacture Date... 1-17 Manufacturer... 1-17 Electromagnetic Compatibility... 1-17

2

Product Overview

2.1 2.2 2.3 2.4 2.5 2.6

Overview...2-1 Ventilator Description...2-2 Indications For Use/Intended Purpose...2-3 Contraindications...2-4 Components List...2-4 Product Views...2-6 GUI Front View... 2-6 GUI Rear View... 2-7 BDU Front View... 2-8 BDU Rear View... 2-10 Ventilator Side Views... 2-14 Mounting Configurations... 2-15

1.1.1 1.2 1.3 1.3.1 1.3.2 1.3.3 1.3.4 1.3.5 1.3.6 1.3.7 1.3.8 1.3.9 1.3.10 1.3.11 1.3.12 1.3.13 1.4 1.4.1 1.4.2

2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.7

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2.8 2.9 2.9.1 2.10 2.10.1 2.10.2 2.10.3 2.10.4 2.10.5 2.11 2.11.1 2.11.2 2.12 2.13 2.14 2.15

Battery Backup... 2-15 Graphical User Interface... 2-16 Primary Display... 2-16 GUI Controls and Indicators... 2-16 Control Keys... 2-16 GUI Touch Screen Unresponsive or Blank: Recommended Responses. 2-18 Visual Indicators... 2-20 On-screen Symbols and Abbreviations... 2-23 Audible Indicators... 2-27 Breath Delivery Unit... 2-28 BDU Controls and Indicators... 2-28 Connectors... 2-39 Additional Equipment... 2-40 Special Features... 2-40 Color Definitions... 2-41 Pneumatic Diagrams... 2-41

3

Installation

3.1 3.2 3.3

Overview...3-1 Safety Reminders...3-1 Product Assembly...3-2 How to Assemble Ventilator Components... 3-2 Product Power Sources... 3-2 Product Placement...3-4 Product Connectivity...3-6 Connecting the Ventilator to AC Power... 3-6 Connecting the Gas Supplies... 3-8 Filter Installation... 3-11 Connecting the Patient Circuit... 3-15 How to Install Accessories... 3-19 Batteries... 3-19 Battery Testing... 3-23 Battery Life... 3-24 Battery Manufacturing Date... 3-24 Battery Disposal... 3-24 Flex Arm... 3-25 Humidifier... 3-26 Ventilator Operating Modes... 3-29 Normal Mode... 3-29 Quick Start... 3-29

3.3.1 3.3.2 3.4 3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.6 3.6.1 3.6.2 3.6.3 3.6.4 3.6.5 3.6.6 3.6.7 3.7 3.7.1 3.7.2

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Table of Contents 3.7.3 3.7.4

3.9.1 3.9.2 3.9.3 3.9.4 3.10

Stand-By State... 3-30 Service Mode... 3-32 Product Configuration... 3-34 Preparing the Ventilator for Use... 3-35 Configuring the GUI... 3-36 Installation Testing... 3-45 SST (Short Self Test)... 3-45 EST (Extended Self Test)... 3-51 EST Test Sequence... 3-53 EST Test Results... 3-56 Operation Verification... 3-57

4

Operation

4.1 4.2 4.3 4.4

Overview...4-1 Ventilator Function...4-1 Ventilator Setup...4-2 User Interface Management...4-2 Using the GUI... 4-3 Adjusting GUI Viewing Properties... 4-5 Using Gestures When Operating the GUI... 4-6 Ventilator Operation...4-7 Ventilator Settings... 4-10 Apnea Settings... 4-15 Alarm Settings... 4-16 Alarm Screen During Operation... 4-18 Making Ventilator Settings Changes... 4-19 Constant Timing Variable During Rate Changes... 4-20 Predicted Body Weight (PBW) Calculation... 4-21 Non-Invasive Ventilation (NIV)... 4-22 NIV Intended Use... 4-22 NIV Breathing Interfaces... 4-23 NIV Setup... 4-23 Conversion from Invasive to NIV Ventilation Type... 4-24 Conversion from NIV to Invasive Ventilation Type... 4-26 High Spontaneous Inspiratory Time Limit Setting... 4-27 NIV Apnea Setup... 4-28 NIV Alarm Settings... 4-29 Manual Inspiration... 4-30 Respiratory Mechanics Maneuvers... 4-30 Inspiratory Pause Maneuver... 4-31

3.8 3.8.1 3.8.2 3.9

4.4.1 4.4.2 4.4.3 4.5 4.5.1 4.5.2 4.5.3 4.5.4 4.5.5 4.5.6 4.6 4.7 4.7.1 4.7.2 4.7.3 4.7.4 4.7.5 4.7.6 4.7.7 4.7.8 4.8 4.9 4.9.1

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4.9.2 4.9.3 4.10 4.10.1 4.10.2 4.10.3 4.11 4.11.1 4.11.2 4.11.3 4.11.4 4.11.5 4.11.6 4.11.7 4.12

Expiratory Pause Maneuver... 4-32 Other Respiratory Maneuvers... 4-33 Oxygen Sensor Function... 4-34 Oxygen Sensor Life... 4-35 Oxygen Sensor Calibration... 4-36 Oxygen Sensor Calibration Testing... 4-36 Ventilator Protection Strategies... 4-36 Power on Self Test (POST)... 4-37 Technical Fault... 4-37 SST... 4-37 Procedure Error... 4-37 Ventilation Assurance... 4-38 Safety Valve Open (SVO)... 4-38 Ventilator Inoperative (Vent Inop)... 4-38 Ventilator Shutdown... 4-39

5

Product Data Output

5.1 5.2 5.3 5.4

5.6 5.7 5.8 5.9

Overview...5-1 Language...5-1 Data Display...5-1 Data Transfer...5-1 GUI Screen Capture... 5-2 Communication Setup... 5-4 Comm Port Configuration... 5-4 Serial Commands... 5-5 RSET Command... 5-6 SNDA Command... 5-6 SNDF Command... 5-10 Communication Ports 5-19 Port Use... 5-20 Retrieving Stored Data... 5-22 Display Configurability... 5-22 Printing Data or Screen Captures... 5-23 Connectivity to External Systems... 5-23

6

Performance

6.1 6.2

Overview...6-1 System Options...6-1

5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7 5.5 5.5.1

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Table of Contents 6.3 6.4 6.4.1 6.4.2 6.4.3 6.5 6.5.1 6.5.2 6.5.3 6.5.4 6.5.5 6.5.6 6.5.7 6.5.8 6.5.9 6.5.10 6.5.11 6.5.12 6.5.13 6.5.14 6.5.15 6.5.16 6.5.17 6.5.18 6.5.19 6.5.20 6.5.21 6.5.22 6.5.23 6.5.24 6.5.25 6.5.26 6.5.27 6.6 6.6.1 6.6.2 6.6.3 6.6.4 6.6.5 6.6.6 6.6.7

Operator’s Manual

Environmental Considerations...6-1 Ventilator Settings...6-1 Ventilation Type... 6-2 Mode... 6-2 Breath Type... 6-2 Alarms...6-4 Alarm Messages... 6-4 Alarm Reset Key... 6-8 Audio Paused Key... 6-9 Alarm Volume Key... 6-9 Alarm Testing... 6-10 Viewing Alarms... 6-15 Alarm Delay... 6-16 Alarm Handling... 6-16 AC POWER LOSS Alarm... 6-32 APNEA Alarm... 6-32 CIRCUIT DISCONNECT Alarm... 6-33 LOSS OF POWER Alarm... 6-33 DEVICE ALERT Alarm... 6-34 HIGH CIRCUIT PRESSURE Alarm... 6-34 HIGH DELIVERED O2% Alarm... 6-35 HIGH EXHALED MINUTE VOLUME Alarm... 6-35 HIGH EXHALED TIDAL VOLUME Alarm... 6-36 HIGH INSPIRED TIDAL VOLUME Alarm... 6-36 HIGH RESPIRATORY RATE Alarm... 6-36 INSPIRATION TOO LONG Alarm... 6-36 LOW CIRCUIT PRESSURE Alarm... 6-37 LOW DELIVERED O2% Alarm... 6-38 LOW EXHALED MANDATORY TIDAL VOLUME Alarm... 6-38 LOW EXHALED SPONTANEOUS TIDAL VOLUME Alarm... 6-39 LOW EXHALED TOTAL MINUTE VOLUME Alarm... 6-39 PROCEDURE ERROR Alarm... 6-39 SEVERE OCCLUSION Alarm... 6-40 Monitored Patient Data... 6-40 Total Exhaled Minute Volume... 6-41 Exhaled Spontaneous Minute Volume... 6-41 Exhaled Tidal Volume... 6-41 Proximal Exhaled Minute Volume... 6-41 Proximal Exhaled Tidal Volume... 6-41 Exhaled Spontaneous Tidal Volume... 6-42 Exhaled Mandatory Tidal Volume... 6-42

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6.6.8 6.6.9 6.6.10 6.6.11 6.6.12 6.6.13 6.6.14 6.6.15 6.6.16 6.6.17 6.6.18 6.6.19 6.6.20 6.6.21 6.6.22 6.6.23 6.6.24 6.6.25 6.6.26 6.6.27 6.6.28 6.6.29 6.6.30 6.6.31 6.6.32 6.6.33 6.6.34 6.6.35 6.6.36 6.6.37 7

Preventive Maintenance

7.1 7.2 7.3 7.4 7.5

Overview...7-1 Ventilator Operational Time...7-1 Preventive Maintenance Intervals...7-1 Surface Cleaning of Exterior Surfaces...7-4 Component Cleaning and Disinfection...7-5 Exhalation Flow Sensor Assembly (EVQ) Disinfection... 7-8 EVQ Reassembly... 7-15 EVQ Replacement... 7-16

7.5.1 7.5.2 7.5.3

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Exhaled mL/kg Volume... 6-42 Inspired Tidal Volume... 6-42 Proximal Inspired Tidal Volume... 6-42 Delivered mL/kg Volume... 6-42 I:E Ratio... 6-43 Mean Circuit Pressure... 6-43 Peak Circuit Pressure... 6-43 End Inspiratory Pressure... 6-43 End Expiratory Pressure... 6-43 Intrinsic PEEP... 6-44 PAV-based Intrinsic PEEP... 6-44 Total PEEP... 6-44 Plateau Pressure... 6-44 Driving Pressure (PDRIVE)... 6-44 Total Respiratory Rate... 6-44 PAV-based Lung Compliance... 6-45 PAV-based Patient Resistance... 6-45 PAV-based Lung Elastance... 6-45 Spontaneous Rapid Shallow Breathing Index... 6-45 Spontaneous Inspiratory Time Ratio... 6-45 Spontaneous Inspiratory Time... 6-45 PAV-based Total Airway Resistance... 6-46 Static Compliance and Static Resistance... 6-46 Dynamic Compliance... 6-47 Dynamic Resistance... 6-48 C20/C... 6-48 End Expiratory Flow... 6-48 Peak Spontaneous Flow... 6-48 Displayed O2%... 6-48 Inspiratory Time Constant (3TauI)... 6-48

Operator’s Manual

Table of Contents 7.5.4 7.6 7.7 7.8 7.9 7.10 7.11

Storage... 7-17 Component Sterilization... 7-18 Service Personnel Preventive Maintenance... 7-19 Safety Checks... 7-20 Inspection and Calibration... 7-20 Documentation... 7-21 Storage for Extended Periods... 7-21

8

Troubleshooting

8.1 8.2 8.3 8.4 8.5 8.6

Overview...8-1 Problem Categories...8-1 How to Obtain Ventilator Service...8-1 Used Part Disposal...8-1 Ventilator Logs...8-2 Diagnostic Codes...8-4

9

Accessories

9.1 9.2

Overview...9-1 General Accessory Information...9-2

10

Theory of Operations

10.1 10.2 10.3 10.4 10.4.1 10.4.2 10.4.3 10.4.4 10.5 10.5.1 10.5.2 10.5.3 10.5.4 10.6 10.6.1 10.6.2 10.7

Overview... 10-1 Theoretical Principles... 10-3 Applicable Technology... 10-3 Inspiration - Detection and initiation... 10-4 Pressure Triggering... 10-5 Flow Triggering... 10-6 Time Triggers... 10-7 Operator-initiated Triggers... 10-8 Exhalation - Detection and Initiation... 10-8 Airway Pressure Method... 10-9 Percent Peak Flow Method...10-10 Time-cycling Method...10-10 Backup Methods...10-11 Compliance and BTPS Compensation... 10-11 Compliance Compensation in Volume-based Breaths...10-11 BTPS Compensation in Volume-based Breaths...10-15 Mandatory Breath Delivery... 10-15

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10.7.1 Volume Control (VC)...10-16 10.7.2 Pressure Control (PC)...10-18 10.7.3 VC+...10-19 10.7.4 Rise Time%...10-20 10.7.5 Manual Inspiration...10-21 10.8 Spontaneous Breath Delivery... 10-21 10.8.1 Pressure Support (PS)...10-23 10.8.2 Volume Support (VS)...10-23 10.8.3 Tube Compensation...10-25 10.8.4 Proportional Assist Ventilation (PAV+™)...10-29 10.9 A/C Mode... 10-29 10.9.1 Changing to A/C Mode...10-31 10.10 SIMV Mode... 10-32 10.10.1 Changing to SIMV Mode...10-35 10.11 Spontaneous (SPONT) Mode... 10-37 10.11.1 Changing to SPONT Mode...10-38 10.12 Apnea Ventilation... 10-39 10.12.1 Apnea Detection...10-39 10.12.2 Transition to Apnea Ventilation...10-41 10.12.3 Settings Changes During Apnea Ventilation...10-41 10.12.4 Resetting Apnea Ventilation...10-42 10.12.5 Apnea Ventilation in SIMV...10-42 10.12.6 Phasing in New Apnea Intervals...10-43 10.13 Detecting Occlusion and Disconnect... 10-43 10.13.1 Occlusion...10-43 10.13.2 Disconnect...10-45 10.13.3 Annunciating Occlusion and Disconnect Alarms...10-47 10.14 Respiratory Mechanics... 10-47 10.14.1 Inspiratory Pause...10-48 10.14.2 Expiratory Pause...10-50 10.14.3 Negative Inspiratory Force (NIF) Maneuver...10-52 10.14.4 P0.1 Maneuver (Occlusion Pressure)...10-53 10.14.5 Vital Capacity (VC) Maneuver...10-53 10.15 Ventilator Settings... 10-54 10.15.1 Apnea Ventilation...10-54 10.15.2 Circuit Type and Predicted Body Weight (PBW)...10-55 10.15.3 Ventilation Type...10-56 10.15.4 Mode and Breath Type...10-58 10.15.5 Respiratory Rate (f)...10-59 10.15.6 Tidal Volume...10-60 10.15.7 Peak Inspiratory Flow...10-60

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Table of Contents 10.15.8 Plateau Time...10-61 10.15.9 Flow Pattern...10-61 10.15.10Flow Sensitivity...10-61 10.15.11Pressure Sensitivity...10-62 10.15.12Inspiratory Pressure...10-62 10.15.13Inspiratory Time...10-63 10.15.14Expiratory Time...10-63 10.15.15I:E Ratio...10-64 10.15.16High Pressure in BiLevel...10-64 10.15.17Low Pressure in BiLevel...10-64 10.15.18High Time in BiLevel...10-64 10.15.19Low Time in BiLevel...10-64 10.15.20TH:TL Ratio in BiLevel...10-65 10.15.21PEEP...10-65 10.15.22Pressure Support...10-65 10.15.23Volume Support...10-66 10.15.24% Supp in TC...10-66 10.15.25% Supp in PAV+™...10-66 10.15.26Rise Time%...10-66 10.15.27Expiratory Sensitivity...10-67 10.15.28Disconnect Sensitivity...10-68 10.15.29High Spontaneous Inspiratory Time Limit...10-69 10.15.30Humidification Type...10-69 10.15.31Humidifier Volume...10-70 10.16 Safety Net... 10-70 10.16.1 User Error...10-70 10.16.2 Patient Related Problems...10-72 10.16.3 System Related Problems...10-72 10.16.4 Background Diagnostic System...10-72 10.17 Power On Self Test (POST)... 10-75 10.18 Short Self Test (SST)... 10-75 10.19 Extended Self Test (EST)... 10-76 11

Specifications

11.1 11.2 11.3 11.4 11.5 11.6

Overview... 11-1 Measurement Uncertainty... 11-1 Physical Characteristics... 11-2 Electrical Specifications... 11-6 Interface Requirements... 11-6 Environmental Specifications... 11-7

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11.7 11.7.1 11.8 11.9 11.10

Performance Specifications... 11-8 Ranges and Resolutions... 11-8 Manufacturer’s Declaration... 11-27 Safety Tests... 11-35 Essential Performance Requirements... 11-35

A

BiLevel 2.0

A.1 A.2 A.3 A.4 A.5 A.6 A.7 A.8 A.9 A.9.1 A.9.2 A.9.3 A.9.4 A.10

Overview... A-1 Intended Use... A-2 Safety Symbol Definitions... A-2 Setting Up BiLevel... A-3 Using Pressure Support with BiLevel... A-4 Manual Inspirations in BiLevel Mode... A-6 Respiratory Mechanics Maneuvers in BiLevel... A-6 Specifications... A-6 Technical Description... A-6 Synchrony in BiLevel... A-7 Patient Monitoring in BiLevel... A-9 APRV Strategy in BiLevel... A-9 Technical Structure of BiLevel...A-10 Mode Changes... A-10

B

Leak Sync

B.1 B.2 B.3 B.4 B.5 B.6

Overview...B-1 Intended Use...B-1 Safety Symbol Definitions...B-1 Leak Sync...B-2 Setting Up Leak Sync...B-3 When Leak Sync is Enabled...B-4 Adjusting Disconnect Sensitivity (DSENS)... B-5 Monitored Patient Data... B-6 Technical Discussion...B-8 Inspired Tidal Volume (VTL) Accuracy During Leak Sync... B-8 Exhaled Tidal Volume (VTE) Accuracy During Leak Sync... B-8 %LEAK Calculation... B-9 Circuit Disconnect Alarm During Leak Sync... B-9

B.6.1 B.6.2 B.7 B.7.1 B.7.2 B.7.3 B.7.4

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Table of Contents C

PAV+™

C.1 C.2 C.3 C.4

Overview... C-1 Intended Use... C-1 Safety Symbol Definitions... C-2 PAV+™... C-3 Setting Up PAV+™... C-5 PBW and Tube ID... C-6 Apnea Parameters Adjustment... C-7 Alarm Settings Adjustment... C-7 PAV+™ Ventilator Settings... C-8 PAV+™ Alarm Settings... C-8 Monitored Data... C-8 PAV+™ Alarms... C-9 Ventilator Settings and Guidance... C-10 Specified Performance...C-10 Graphics Displays in PAV+™...C-11 WOB Terms and Definitions...C-12 Technical Description...C-13 Protection Against Hazard...C-17

C.4.1 C.4.2 C.4.3 C.4.4 C.4.5 C.4.6 C.4.7 C.4.8 C.5 C.5.1 C.5.2 C.5.3 C.5.4 C.5.5 D

NeoMode 2.0

D.1 D.2 D.3 D.4 D.5 D.6 D.7 D.8

Overview... D-1 Intended Use... D-1 Description... D-1 Safety Information... D-2 Neonatal Door and Filter Installation... D-3 How to Empty the Condensate Vial... D-5 How to Connect the Breathing Circuit... D-6 Ventilation Features... D-8 SST (Short Self Test)...D-9 Elevate O2...D-9 CPAP Mode... D-10 Entering CPAP From Other Ventilation Modes... D-11 Exiting CPAP Mode... D-12 Compliance Compensation... D-12 Settings, Alarms, and Monitored Patient Data... D-12

D.8.1 D.8.2 D.8.3 D.8.4 D.8.5 D.8.6 D.8.7

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E

Proximal Flow

E.1 E.2 E.3

Overview...E-1 Intended Use...E-1 Proximal Flow Option Description...E-1 E.3.1 Proximal Flow Option components... E-2 E.4 Safety Symbol Definitions...E-2 E.5 Software and Hardware Requirements...E-3 E.6 Safety Information...E-3 E.7 On-screen symbols...E-6 E.8 Sensor Calibration and Sensor Line Purging...E-7 E.9 SST Requirements...E-8 E.9.1 Attaching the Proximal Flow Sensor for SST... E-10 E.10 Disabling and Enabling the Proximal Flow Option... E-11 E.11 Using the Proximal Flow Sensor... E-12 E.11.1 How to Perform a Manual Purge... E-14 E.12 Alarms... E-14 E.13 Ranges, Resolutions, and Accuracies... E-15 E.13.1 Proximal Flow Sensor Specifications... E-16 E.14 Part Numbers... E-16 F

Trending

F.1 F.2 F.3 F.4 F.5 F.6 F.7

Overview...F-1 Intended Use...F-1 Safety Reminder...F-1 Trending Description...F-1 Setting Up Trending...F-2 Trend Parameters...F-3 Viewing Trended Parameters...F-7 Time Scales... F-7 Events... F-8 Trending Presets... F-12 Adult and Pediatric Trending Presets... F-12 Neonatal Trending Presets... F-12 Data Gaps... F-13

F.7.1 F.7.2 F.8 F.8.1 F.8.2 F.9 Glossary Index

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List of Tables Table 1-1. Table 1-2. Table 2-1. Table 2-2. Table 2-3. Table 2-4. Table 2-5. Table 2-6. Table 2-7. Table 2-8. Table 2-9. Table 2-10. Table 2-11. Table 3-1. Table 3-2. Table 3-3. Table 3-4. Table 3-5. Table 3-6. Table 3-7. Table 3-8. Table 3-9. Table 3-10. Table 4-1. Table 4-2. Table 4-3. Table 4-4. Table 4-5. Table 5-1. Table 5-2. Table 6-1. Table 6-2. Table 6-3. Table 6-4. Table 6-5. Table 6-6. Table 7-1. Table 7-2. Table 7-3. Table 7-4. Table 7-5.

Operator’s Manual

Shipping Carton Symbols and Descriptions... 1-2 Safety Symbol Definitions... 1-4 Typical Packing List... 2-5 BDU Front Label Symbols and Descriptions... 2-9 BDU Rear Label or Panel Symbols and Descriptions... 2-11 Common Symbols found on GUI or BDU Labels... 2-13 GUI Control Keys... 2-16 GUI Visual Indicators... 2-21 Symbols and Abbreviations... 2-24 GUI Audible Indicator Functions... 2-28 Status Display Indicators and Descriptions... 2-33 BDU Audible Indicator Functions... 2-39 Color Legend... 2-41 Patient Types and PBW Values... 3-16 Ventilator Configuration... 3-34 SST tests... 3-48 Humidifier Volumes For Adult and Pediatric Patients... 3-48 Humidifier Volumes-Neonatal Patients... 3-49 Individual SST Results... 3-49 Overall SST Outcomes... 3-50 EST Tests... 3-54 EST Test Step Results... 3-56 Overall EST Outcomes... 3-57 Gestures and Their Meanings... 4-6 Allowable Ventilator Settings... 4-15 Setting Up a Patient for NIV... 4-23 Invasive to NIV on Same Patient... 4-24 NIV to Invasive on Same Patient... 4-27 MISCA Response... 5-7 MISCF Response... 5-11 Alarm Descriptions and Symbols... 6-7 Alarm Prioritization... 6-17 Technical Alarm Categories... 6-18 Technical Alarms... 6-18 Non-technical Alarm Summary... 6-19 Non-Technical Alarms and Suggested Responses... 6-28 Operator Preventive Maintenance Frequency... 7-2 Surface Cleaning Agents... 7-5 Component Cleaning Agents and Disinfection Procedures... 7-6 Sterilization Parameters... 7-18 Component Sterilization Procedures... 7-18

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Table 7-6. Table 9-1. Table 10-1. Table 10-2. Table 10-3. Table 10-4. Table 10-5. Table 10-6. Table 10-7. Table 10-8. Table 10-9. Table 10-10. Table 11-1. Table 11-2. Table 11-3. Table 11-4. Table 11-5. Table 11-6. Table 11-7. Table 11-8. Table 11-9. Table 11-10. Table 11-11. Table 11-12. Table 11-13. Table 11-14. Table 11-15. Table 11-16. Table 11-17. Table 11-18. Table 11-19. Table 11-20. Table A-1. Table B-1. Table B-2. Table B-3. Table C-1. Table C-2. Table C-3. Table C-4.

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Service Preventive Maintenance Frequency... 7-19 Accessories and Options... 9-3 Compliance Volume Factors...10-15 Maximum Pressure Adjustments...10-20 Spontaneous Breath Delivery Characteristics...10-22 Maximum Pressure Adjustments...10-25 Inspiratory and Expiratory Pause Events...10-49 Values for VT Based on Circuit Type...10-56 Peak Flow and Circuit Type (Leak Sync Disabled)...10-56 Modes and Breath Types...10-58 Safety PCV Settings...10-71 Inspiratory Backup Ventilation Setting s...10-74 Performance Verification Equipment Uncertainty... 11-1 Physical Characteristics... 11-2 Pneumatic Specifications... 11-3 Technical Specifications... 11-3 Electrical Specifications... 11-6 Interface Pin Designations... 11-6 Nurse Call Pin Designations... 11-7 Environmental Specifications... 11-7 Ventilator Settings Range and Resolution... 11-8 Alarm Settings Range and Resolution...11-15 Patient Data Range and Resolution...11-18 Delivery Accuracy...11-25 Monitoring (Patient Data) Accuracy...11-25 Computed Value Accuracy...11-26 Electromagnetic Emissions...11-28 Electromagnetic Immunity...11-29 Immunity to Proximity Fields RF Wireless Communications Equipment...11-32 AIM Standard Test Levels...11-33 Recommended Separation Distances for RF...11-34 Recommended Cables...11-35 Safety Symbol Definitions... A-3 Safety Symbol Definitions... B-1 Maximum Leak Compensation Flow Based on Patient Type... B-2 DSENS settings... B-6 Safety Symbol Definitions... C-2 Absolute limits for PAV+™ Monitored Data... C-9 PAV+™ Work of Breathing terms...C-12 Default PBW-based Resistance Values...C-22

Operator’s Manual

List of Tables Table D-1. Recommended Breathing Circuits...D-8 Table D-2. Allowable NeoMode Ventilator Settings and Ventilation Type...D-8 Table D-3. Humidifier Volumes-Neonatal Patients...D-9 Table D-4. Delivered Volume Accuracy... D-14 Table D-5. Monitored Inspired Volume (VTI) Accuracy... D-14 Table D-6. Monitored Exhaled Tidal Volume (VTE) Accuracy... D-14 Table E-1. Safety Symbol Definitions... E-3 Table E-2. Proximal Flow Option Data Symbols... E-7 Table E-3. Proximal Flow Option SST Tests... E-9 Table E-4. Proximal Flow Sensor Volume Accuracy... E-16 Table E-5. Proximal Flow Sensor Specifications... E-16 Table E-6. Proximal Flow Option and Component Part Numbers... E-16 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-8 Table F-4. Events... F-9 Table Glossary-1. Glossary of Ventilation Terms... Glossary-1 Table Glossary-2. Units of Measure... Glossary-8 Table Glossary-3. Technical Abbreviations... Glossary-9

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Page Left Intentionally Blank

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List of Figures Figure 2-1. Figure 2-2. Figure 2-3. Figure 2-4. Figure 2-5. Figure 2-6. Figure 2-7. Figure 2-8. Figure 2-9. Figure 2-10. Figure 2-11. Figure 2-12. Figure 3-1. Figure 3-2. Figure 3-3. Figure 3-4. Figure 3-5. Figure 3-6. Figure 3-7. Figure 3-8. Figure 3-9. Figure 3-10. Figure 3-11. Figure 3-12. Figure 3-13. Figure 3-14. Figure 3-15. Figure 3-16. Figure 3-17. Figure 3-18. Figure 4-1. Figure 4-2. Figure 4-3. Figure 4-4. Figure 4-5. Figure 4-6. Figure 4-7. Figure 4-8. Figure 4-9. Figure 4-10. Figure 4-11.

Operator’s Manual

GUI Front View... 2-6 GUI Rear View... 2-7 BDU Front View... 2-8 BDU Rear View... 2-10 Installed Software Options... 2-11 Ventilator Right Side View... 2-14 Ventilator Left Side View... 2-15 Ventilator Power Switch and AC Indicator... 2-29 Service Mode Button (TEST)... 2-30 Sample Status Display During Normal Ventilation... 2-32 Pneumatic Diagram (Compressor Shown)... 2-42 Pneumatic Diagram - Compressor and Prox Flow Systems... 2-44 Example of Freestanding Ventilator Placement... 3-5 Example of a Pendant-mounted Ventilator... 3-5 Power Cord Retainer on BDU (without spacers)... 3-7 Power Cord Retainer on BDU (with spacers)... 3-8 Connecting the Ventilator to the Gas Supplies... 3-10 Adult and Pediatric Filter Installation... 3-13 Installing the Neonatal Filter... 3-14 Drain Bag... 3-15 Connecting the Adult or Pediatric Patient Circuit... 3-17 Connecting the Neonatal Patient Circuit... 3-18 Ventilator Battery... 3-20 Proper Battery Orientation... 3-21 Battery Compartment Locations... 3-22 Battery manufacturing date... 3-24 Flex Arm Installation... 3-25 Bracket Installation on Rail... 3-27 Humidifier Installation to Ventilator... 3-28 Service Mode Button (TEST)... 3-33 Areas of the GUI... 4-3 Pushpin Icon... 4-5 New Patient Settings... 4-9 Open Menu Tab... 4-11 New Patient Setup Screen... 4-12 Apnea Setup Screen... 4-16 Alarms Settings Screen... 4-17 Alarm Screen During Operation... 4-19 Vent Setup Button “NIV” Indicating NIV ventilation type... 4-26 2TI SPONT Indicator... 4-28 Default NIV Alarm Settings... 4-29

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Figure 4-12. Figure 4-13. Figure 4-14. Figure 5-1. Figure 5-2. Figure 5-3. Figure 6-1. Figure 7-1. Figure 7-2. Figure 7-3. Figure 7-4. Figure 7-5. Figure 7-6. Figure 7-7. Figure 7-8. Figure 7-9. Figure 7-10. Figure 7-11. Figure 7-12. Figure 8-1. Figure 9-1. Figure 9-2. Figure 10-1. Figure 10-2. Figure 10-3. Figure 10-4. Figure 10-5. Figure 10-6. Figure 10-7. Figure 10-8. Figure 10-9. Figure 10-10. Figure 10-11. Figure 10-12. Figure 10-13. Figure 10-14. Figure 10-15. Figure 10-16. Figure 10-17. Figure 10-18. Figure 10-19.

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RM in Menu Tab... 4-30 Respiratory Maneuver Tabs... 4-31 More Settings Screen with O2 Sensor Enabled... 4-35 Incompatible USB Device Message... 5-3 Comm Setup Screen... 5-4 Port Locations... 5-20 Alarm Message Format... 6-6 EVQ... 7-9 EVQ Components... 7-9 EVQ Removal... 7-10 Exhalation Valve Diaphragm Removal... 7-11 Exhalation Filter Seal Removal... 7-11 Pressure Sensor Filter Removal... 7-12 Immersion Method... 7-13 EVQ Reprocessing Kit... 7-15 Installing the Pressure Sensor Filter... 7-15 Installing the Exhalation Filter Seal... 7-16 Installing the Diaphragm... 7-16 Installing the EVQ... 7-17 Log Screen... 8-4 Ventilator with Accessories... 9-2 Additional Accessories... 9-3 Inspiration Using Pressure Sensitivity... 10-6 Inspiration Using Flow Sensitivity... 10-7 Breath Activity During Time-triggered Inspiration... 10-8 Exhalation via the Airway Pressure Method... 10-9 Typical Flow-cycled breath...10-10 Square Flow Pattern...10-12 Descending Ramp Flow Pattern...10-13 Ideal Waveform Using Square Flow Pattern...10-17 Ideal Waveform Using Descending Ramp Flow Pattern...10-17 Ideal Waveform Using Pressure Control Ventilation...10-18 ET Tube Target Pressure vs. Flow...10-28 Tracheostomy Tube Target Pressure vs. Flow...10-29 No Patient Inspiratory Effort Detected...10-30 Patient Inspiratory Effort Detected...10-31 Combined VIM and PIM Breaths...10-31 Mandatory and Spontaneous Intervals...10-32 PIM Delivered Within Mandatory Interval...10-33 PIM Not Delivered Within Mandatory Interval...10-33 Apnea Interval Equals Breath Period...10-40

Operator’s Manual

List of Figures Figure 10-20. Figure 10-21. Figure 10-22. Figure A-1. Figure A-2. Figure A-3. Figure A-4. Figure A-5. Figure A-6. Figure B-1. Figure B-2. Figure B-3. Figure B-4. Figure C-1. Figure C-2. Figure C-3. Figure D-1. Figure D-2. Figure D-3. Figure E-1. Figure E-2. Figure E-3. Figure E-4. Figure E-5. Figure E-6. Figure E-7. Figure E-8. Figure F-1.

Operator’s Manual

Apnea Interval Greater Than Breath Period...10-40 Apnea Interval Less Than Breath Period...10-41 Apnea Ventilation in SIMV...10-43 Spontaneous Breathing at PL... A-1 BiLevel Mode... A-2 BiLevel Setup Screen... A-4 BiLevel with Pressure Support... A-5 Spontaneous and Synchronous Intervals... A-8 APRV With Spontaneous Breathing at PH... A-9 Enabling Leak Sync... B-3 GUI Screen when Leak Sync is Enabled... B-5 Leak Sync Monitored Patient Data... B-7 Circuit Disconnect During VC... B-9 Ventilator Setup Screen... C-5 Graphics displays in PAV+™...C-12 Use of Default Lung Resistance...C-21 Installing the Neonatal Filter and Door...D-4 How to Connect the Breathing Circuit...D-7 CPAP Setup Screen... D-11 Proximal Flow Sensor... E-2 Sample GUI screen Showing Proximal Flow Data... E-6 Message During Autozero and Purge Processes... E-8 Attaching the Proximal Flow Sensor to the Ventilator... E-10 Enabling and Disabling the Proximal Flow Sensor... E-11 Attaching the Proximal Flow Sensor... E-13 Manual Purge... E-14 Alarm Message-Prox Inoperative... E-15 Accessing Trending via the Menu Tab... F-2

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