980 Series Operators Manual Rev A

Table of Contents 1

Introduction

1.1 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 1.5 1.6 1.7 1.8 2

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... 1-4 Warnings Regarding Environment of Use... 1-6 Warnings Before Using Equipment... 1-7 Warnings Regarding Electrical Power... 1-8 Warnings Regarding Ventilator Settings... 1-8 Warnings Regarding Hoses, Tubing, and Accessories... 1-9 Warnings Regarding Gas Sources...1-10 Warnings Regarding Infection Control...1-11 Warnings Regarding Ventilator Maintenance...1-11 Cautions...1-11 Notes...1-13 Obtaining Technical Assistance... 1-13 Technical Services...1-13 On-screen Help...1-14 Warranty Information... 1-14 Manufacture Date... 1-14 Manufacturer... 1-15 Electromagnetic Compatibility... 1-15 Product Overview

2.1 2.2 2.3 2.4 2.5 2.6 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.7 2.8 2.9

Operator’s Manual

Overview... 2-1 Ventilator Description... 2-2 Indications for Use/Intended Purpose... 2-3 Contraindications... 2-4 Components List... 2-4 Product Views... 2-5 GUI Front View... 2-5 GUI Rear View... 2-6 BDU Front View... 2-7 BDU Rear View... 2-8 Ventilator Side Views...2-12 Mounting Configurations... 2-13 Battery Backup... 2-14 Graphical User Interface... 2-14

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Table of Contents 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 3

Installation

3.1 3.2 3.3 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 3.6.8 3.7 3.7.1 3.7.2 3.7.3 3.7.4 3.8

iv

Primary Display...2-14 GUI Controls and Indicators... 2-15 Control Keys...2-15 GUI Touch Screen Reset...2-16 Visual Indicators...2-16 On-screen Symbols and Abbreviations...2-19 Audible Indicators...2-22 Breath Delivery Unit... 2-23 BDU Controls and Indicators...2-24 Connectors...2-33 Additional Equipment... 2-33 Special Features... 2-34 Color Definitions... 2-34 Pneumatic Diagrams... 2-34

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... 3-5 Connecting the Ventilator to AC Power... 3-5 Connecting the Gas Supplies... 3-7 Filter Installation... 3-9 Connecting the Patient Circuit...3-13 How to Install Accessories... 3-17 Batteries...3-17 Battery Testing...3-21 Battery Performance Test Results...3-21 Battery Life...3-23 Battery Manufacturing Date...3-23 Battery Disposal...3-24 Flex Arm...3-24 Humidifier...3-25 Ventilator Operating Modes... 3-28 Normal Mode...3-28 Quick Start...3-28 Stand-By State...3-28 Service Mode...3-30 Product Configuration... 3-32

Operator’s Manual

Table of Contents 3.8.1 3.8.2 3.9 3.9.1 3.9.2 3.9.3 3.9.4 3.9.5 3.10 4

Preparing the Ventilator for Use...3-33 Configuring the GUI...3-34 Installation Testing... 3-41 SST (Short Self Test)...3-41 Flow Sensor Calibration...3-47 Extended Self Test (EST)...3-50 EST Test Sequence...3-52 EST Test Results...3-54 Operation Verification... 3-55 Operation

4.1 4.2 4.3 4.4 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 4.9.2 4.9.3 4.10 4.10.1

Operator’s Manual

Overview... 4-1 Ventilator Function... 4-1 Ventilator Setup... 4-2 User Interface Management... 4-2 Using the GUI... 4-2 Adjusting GUI Viewing Properties... 4-4 Using Gestures When Operating the GUI... 4-5 Ventilator Operation... 4-7 Ventilator Settings... 4-9 Apnea Settings...4-13 Alarm Settings...4-14 Alarm Screen During Operation...4-16 Making Ventilator Settings Changes...4-17 Constant Timing Variable During Respiratory Rate Changes...4-18 Predicted Body Weight (PBW) Calculation... 4-18 Non-invasive Ventilation (NIV)... 4-19 NIV Intended Use...4-19 NIV Breathing Interfaces...4-19 NIV Setup...4-20 Conversion from Invasive to NIV Ventilation Type...4-21 Conversion from NIV to Invasive Ventilation Type...4-22 High Spontaneous Inspiratory Time Limit Setting...4-22 NIV Apnea Setup...4-23 NIV Alarm Settings...4-24 Manual Inspiration... 4-24 Respiratory Mechanics Maneuvers... 4-25 Inspiratory Pause Maneuver...4-26 Expiratory Pause Maneuver...4-27 Other Respiratory Maneuvers...4-28 Oxygen Sensor Function... 4-28 Oxygen Sensor Life...4-29

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Table of Contents 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 5

Product Data Output

5.1 5.2 5.3 5.4 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 5.6 5.7 5.8 5.9 6

Overview... 5-1 Language... 5-1 Data Display... 5-1 Data Transfer... 5-1 GUI Screen Capture... 5-2 Communication Setup... 5-3 Comm Port Configuration... 5-4 Serial Commands... 5-5 RSET Command... 5-5 SNDA Command... 5-5 SNDF Command... 5-9 Communication Ports... 5-16 Port Use...5-17 Retrieving Stored Data... 5-19 Display Configurability... 5-19 Printing Data or Screen Captures... 5-19 Connectivity to External Systems... 5-19 Performance

6.1 6.2 6.3 6.4 6.4.1 6.4.2 6.4.3 6.5 6.5.1

vi

Oxygen Sensor Calibration...4-30 Oxygen Sensor Calibration Testing...4-30 Ventilator Protection Strategies... 4-30 Power On Self Test (POST)...4-30 Technical Fault...4-31 SST...4-31 Procedure Error...4-31 Ventilation Assurance...4-31 Safety Valve Open (SVO)...4-31 Ventilator Inoperative (Vent Inop)...4-32 Ventilator Shutdown... 4-32

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

Operator’s Manual

Table of Contents 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 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

Operator’s Manual

Alarm Reset Key... 6-7 Audio Paused Key... 6-7 Alarm Volume Key... 6-8 Alarm Testing... 6-8 Viewing Alarms...6-13 Alarm Delay...6-13 Alarm Handling...6-13 AC POWER LOSS Alarm...6-29 APNEA Alarm...6-30 CIRCUIT DISCONNECT Alarm...6-30 LOSS OF POWER Alarm...6-31 DEVICE ALERT Alarm...6-31 HIGH CIRCUIT PRESSURE (1PPEAK) Alarm...6-31 HIGH DELIVERED O2% (1O2%) Alarm...6-32 HIGH EXHALED MINUTE VOLUME (1VE TOT) Alarm...6-32 HIGH EXHALED TIDAL VOLUME (1VTE) Alarm...6-32 HIGH INSPIRED TIDAL VOLUME (1VTI) Alarm...6-32 HIGH RESPIRATORY RATE (1fTOT) Alarm...6-33 INSPIRATION TOO LONG Alarm...6-33 LOW CIRCUIT PRESSURE (3PPEAK) Alarm...6-33 LOW DELIVERED O2% (3O2%) Alarm...6-34 LOW EXHALED MANDATORY TIDAL VOLUME (3VTE MAND) Alarm...6-34 LOW EXHALED SPONTANEOUS TIDAL VOLUME (3VTE SPONT) Alarm...6-35 LOW EXHALED TOTAL MINUTE VOLUME (3VE TOT) Alarm...6-35 PROCEDURE ERROR Alarm...6-35 SEVERE OCCLUSION Alarm...6-35 Monitored Patient Data... 6-36 Total Exhaled Minute Volume (VE TOT)...6-36 Exhaled Spontaneous Minute Volume (VE SPONT)...6-36 Exhaled Tidal Volume (VTE)...6-36 Proximal Exhaled Minute Volume (VE TOTY)...6-37 Proximal Exhaled Tidal Volume (VTEY)...6-37 Exhaled Spontaneous Tidal Volume (VTE SPONT)...6-37 Exhaled Mandatory Tidal Volume (VTE MAND)...6-37 Exhaled mL/kg Volume...6-37 Inspired Tidal Volume (VTI)...6-37 Proximal Inspired Tidal Volume (VTIY)...6-37 Delivered mL/kg Volume...6-37 I:E Ratio...6-38 Mean Circuit Pressure (PMEAN)...6-38 Peak Circuit Pressure (PPEAK)...6-38 End Inspiratory Pressure (PI END)...6-38 End Expiratory Pressure (PEEP)...6-38

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Table of Contents 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 7

Preventive Maintenance

7.1 7.2 7.3 7.4 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.6 7.7 7.8 7.9 7.10 8 8.1 8.2 8.3

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Intrinsic PEEP (PEEPI)...6-38 PAV-based Intrinsic PEEP (PEEPI PAV)...6-38 Total PEEP (PEEPL)...6-39 Plateau Pressure (PPL)...6-39 Total Respiratory Rate (fTOT)...6-39 PAV-based Lung Compliance (CPAV)...6-39 PAV-based Patient Resistance (RPAV)...6-39 PAV-based Lung Elastance (EPAV)...6-39 Spontaneous Rapid Shallow Breathing Index (f/VT)...6-39 Spontaneous Inspiratory Time Ratio (TI/TTOT)...6-40 Spontaneous Inspiratory Time (TI SPONT)...6-40 PAV-based Total Airway Resistance (RTOT)...6-40 Static Compliance (CSTAT) and Static Resistance (RSTAT)...6-40 Dynamic Compliance (CDYN)...6-41 Dynamic Resistance (RDYN)...6-42 C20/C...6-42 End Expiratory Flow (EEF)...6-42 Peak Spontaneous Flow (PSF)...6-42 Displayed O2%...6-42 Inspiratory Time Constant (3TauI)...6-42

Overview... 7-1 Ventilator Operational Time... 7-1 Preventive Maintenance Intervals... 7-1 Surface Cleaning of Exterior Surfaces... 7-3 Component Cleaning and Disinfection... 7-4 Exhalation Flow Sensor Assembly (EVQ) Disinfection... 7-6 EVQ Reassembly...7-13 EVQ Replacement...7-14 Storage...7-15 Service Personnel Preventive Maintenance... 7-15 Safety Checks... 7-17 Inspection and Calibration... 7-17 Documentation... 7-17 Storage for Extended Periods... 7-17 Troubleshooting Overview... 8-1 Problem Categories... 8-1 How to Obtain Ventilator Service... 8-1

Operator’s Manual

Table of Contents 8.4 8.5 8.6

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... 9-1

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 10.7.1 10.7.2 10.7.3 10.7.4 10.7.5 10.8 10.8.1 10.8.2 10.8.3 10.8.4 10.9 10.9.1 10.10 10.10.1 10.11

Operator’s Manual

Overview... 10-1 Theoretical Principles... 10-3 Applicable Technology... 10-3 Inspiration-Detection and Initiation... 10-4 Pressure Triggering...10-4 Flow Triggering...10-5 Time Triggers...10-6 Operator-initiated Triggers...10-7 Exhalation-Detection and Initiation... 10-7 Airway Pressure Method...10-7 Percent Peak Flow Method...10-8 Time-cycling Method...10-9 Backup Methods...10-9 Compliance and BTPS Compensation...10-10 Compliance Compensation in Volume-based Breaths... 10-10 BTPS Compensation in Volume-based Breaths... 10-13 Mandatory Breath Delivery...10-13 Volume Control (VC)... 10-14 Pressure Control (PC)... 10-15 VC+... 10-16 Rise time%... 10-17 Manual Inspiration... 10-18 Spontaneous Breath Delivery...10-18 Pressure Support (PS)... 10-20 Volume Support (VS)... 10-20 Tube Compensation... 10-22 Proportional Assist Ventilation (PAV+™)... 10-25 A/C Mode...10-25 Changing to A/C Mode... 10-27 SIMV Mode...10-28 Changing to SIMV Mode... 10-30 Spontaneous (SPONT) Mode...10-32

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Table of Contents 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... 10-35 10.12.5 Apnea Ventilation in SIMV... 10-36 10.12.6 Phasing in New Apnea Intervals... 10-36 10.13 Detecting Occlusion and Disconnect... 10-37 10.13.1 Occlusion... 10-37 10.13.2 Disconnect... 10-38 10.13.3 Annunciating Occlusion and Disconnect Alarms... 10-39 10.14 Respiratory Mechanics... 10-39 10.14.1 Inspiratory Pause... 10-41 10.14.2 Expiratory Pause... 10-43 10.14.3 Negative Inspiratory Force (NIF) Maneuver... 10-44 10.14.4 P0.1 Maneuver (Occlusion Pressure)... 10-45 10.14.5 Vital Capacity (VC) Maneuver... 10-45 10.15 Ventilator Settings... 10-46 10.15.1 Apnea Ventilation... 10-46 10.15.2 Circuit Type and Predicted Body Weight (PBW)... 10-47 10.15.3 Ventilation Type... 10-48 10.15.4 Mode and Breath Type... 10-48 10.15.5 Respiratory Rate (f)... 10-50 10.15.6 Tidal Volume (VT)... 10-50 10.15.7 Peak Inspiratory Flow (VMAX)... 10-51 10.15.8 Plateau Time (TPL)... 10-51 10.15.9 Flow Pattern... 10-51 10.15.10 Flow Sensitivity (VSENS)... 10-52 10.15.11 Pressure Sensitivity (PSENS)... 10-52 10.15.12 Inspiratory Pressure (PI)... 10-52 10.15.13 Inspiratory Time (TI)... 10-53 10.15.14 Expiratory Time (TE)... 10-53 10.15.15 I:E Ratio... 10-53 10.15.16 High Pressure (PH) in BiLevel... 10-54 10.15.17 Low Pressure (PL) in BiLevel... 10-54 10.15.18 High Time (TH) in BiLevel... 10-54 10.15.19 Low Time (TL) in BiLevel... 10-54 10.15.20 TH:TL Ratio in BiLevel... 10-54 10.15.21 PEEP... 10-54 10.15.22 Pressure Support (PSUPP)... 10-55 10.15.23 Volume Support (VT SUPP)... 10-55 10.15.24 % Supp in TC... 10-55

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Operator’s Manual

Table of Contents 10.15.25 % Supp in PAV+™... 10-56 10.15.26 Rise Time%... 10-56 10.15.27 Expiratory Sensitivity (ESENS)... 10-56 10.15.28 Disconnect Sensitivity (DSENS)... 10-57 10.15.29 High Spontaneous Inspiratory Time Limit (2TI SPONT)... 10-58 10.15.30 Humidification Type... 10-58 10.15.31 Humidifier Volume... 10-58 10.16 Safety Net...10-59 10.16.1 User Error... 10-59 10.16.2 Patient Related Problems... 10-60 10.16.3 System Related Problems... 10-60 10.16.4 Background Diagnostic System... 10-61 10.17 Power On Self Test (POST)...10-63 10.18 Short Self Test (SST)...10-63 10.19 Extended Self Test (EST)...10-63 11

Specifications

11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.7.1 11.8 11.9 11.10 A

Overview... 11-1 Measurement Uncertainty... 11-1 Physical Characteristics... 11-2 Electrical Specifications... 11-5 Interface Requirements... 11-5 Environmental Specifications... 11-6 Performance Specifications... 11-7 Ranges and Resolutions...11-7 Manufacturer’s Declaration...11-25 Safety Tests...11-31 Essential Performance Requirements...11-31 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

Operator’s Manual

Overview... A-1 Intended Use... A-2 Safety Reminder... A-2 Setting Up BiLevel... A-3 Using Pressure Support with BiLevel... A-4 Manual Inspirations in BiLevel Mode... A-5 Respiratory Mechanics Maneuvers in BiLevel... A-5 Specifications... A-5 Technical Description... A-6 Synchrony in BiLevel...A-6 Patient Monitoring in BiLevel...A-8

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Table of Contents A.9.3 A.9.4 A.10 B

Leak Sync

B.1 B.2 B.3 B.4 B.5 B.6 B.6.1 B.6.2 B.7 B.7.1 B.7.2 B.7.3 B.7.4 C

Overview... B-1 Intended Use... B-1 Safety Reminder... B-1 Leak Sync... B-1 Setting Up Leak Sync... B-2 When Leak Sync is Enabled... B-3 Adjusting Disconnect Sensitivity (DSENS)... B-4 Monitored Patient Data... B-5 Technical Discussion... B-6 Inspired Tidal Volume (VTL) Accuracy During Leak Sync... B-6 Exhaled Tidal Volume (VTE) Accuracy During Leak Sync... B-7 %LEAK Calculation... B-7 CIRCUIT DISCONNECT Alarm During Leak Sync... B-7 PAV+™

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

xii

APRV Strategy in BiLevel...A-8 Technical Structure of BiLevel...A-9 Mode Changes... A-9

Overview... C-1 Intended Use... C-1 Safety Information... C-1 PAV+™... C-2 Setting Up PAV+™...C-3 PBW and Tube ID...C-5 Apnea Parameters Adjustment...C-6 Alarm Settings Adjustment...C-6 PAV+™ Ventilator Settings...C-6 PAV+™ Alarm Settings...C-6 Monitored Data...C-7 PAV+™ Alarms...C-7 Ventilator Settings and Guidance... C-8 Specified Performance...C-8 Graphics Displays in PAV+™...C-9 WOB Terms and Definitions...C-9 Technical Description... C-11 Protection Against Hazard... C-14

Operator’s Manual

Table of Contents D

NeoMode 2.0

D.1 D.2 D.3 D.4 D.5 D.6 D.7 D.8 D.8.1 D.8.2 D.8.3 D.8.4 D.8.5 D.8.6 D.8.7 D.8.8 E

Overview...D-1 Intended Use...D-1 Description...D-1 Safety Information...D-1 Neonatal Door and Filter Installation...D-2 How to Empty the Condensate Vial...D-4 How to Connect the Breathing Circuit...D-5 Ventilation Features...D-7 Short Self Test (SST)... D-7 Predicted Body Weight (PBW) vs. Patient Length... D-8 Elevate O2... D-8 CPAP Mode... D-8 Entering CPAP From Other Ventilation Modes... D-9 Exiting CPAP Mode... D-10 Compliance Compensation... D-10 Settings, Alarms, and Monitored Patient Data... D-10 Proximal Flow

E.1 E.2 E.3 E.4 E.4.1 E.5 E.6 E.7 E.8 E.8.1 E.9 E.10 E.10.1 E.11 E.12 E.12.1 E.13 F F.1 F.2

Operator’s Manual

Overview... E-1 Intended Use... E-1 Safety Information... E-1 Proximal Flow Option Description... E-3 Proximal Flow Option Components... E-4 Hardware Requirements... E-4 On-screen Symbols... E-5 Sensor Calibration and Sensor Line Purging... E-6 SST Requirements... E-7 Attaching the Proximal Flow Sensor for SST... E-8 Disabling/Enabling the Proximal Flow Option... E-9 Using the Proximal Flow Sensor... E-10 How to Perform a Manual Purge...E-12 Alarms... E-12 Ranges, Resolutions, and Accuracies... E-13 Proximal Flow Sensor Specifications...E-13 Part Numbers... E-14 Trending Overview... F-1 Intended Use... F-1

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Table of Contents F.3 F.4 F.5 F.6 F.7 F.7.1 F.7.2 F.8 F.8.1 F.8.2 F.9

Safety Reminder... F-1 Trending Description... F-1 Setting Up Trending... F-2 Trend Parameters... F-3 Viewing Trended Parameters... F-6 Time Scales... F-7 Events... F-7 Trending Presets... F-10 Adult and Pediatric Trending Presets...F-11 Neonatal Trending Presets...F-11 Data Gaps... F-12

Glossary Index

xiv

Operator’s Manual

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 2-13. 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 3-19. Figure 3-20. Figure 3-21. Figure 3-22. Figure 3-23. Figure 4-1. Figure 4-2. Figure 4-3. Figure 4-4. Figure 4-5. Figure 4-6. Figure 4-7.

Operator’s Manual

GUI Front View... 2-5 GUI Rear View... 2-6 BDU Front View... 2-7 BDU Rear View... 2-8 Installed Software Options... 2-9 Ventilator Right Side View... 2-12 Ventilator Left Side View... 2-13 Pendant-mount Ventilator Configuration... 2-14 Ventilator Power Switch and AC Indicator... 2-24 Service Mode Button (TEST)... 2-25 Sample Status Display During Normal Ventilation... 2-26 Pneumatic Diagram (Compressor Shown)... 2-35 Pneumatic Diagram-Compressor and Prox Flow Options... 2-37 Example of Freestanding Ventilator Placement... 3-4 Example of Pendant-mounted Ventilator... 3-5 Power cord Retainer on BDU (without spacers)... 3-6 Power Cord Retainer on BDU (with spacers)... 3-7 Connecting the Ventilator to the Gas Supplies... 3-8 Adult/Pediatric Filter Installation... 3-11 Installing the Neonatal Filter... 3-12 Drain Bag... 3-13 Connecting the Adult or Pediatric Patient Circuit... 3-15 Connecting the Neonatal Patient Circuit... 3-16 Battery... 3-18 Proper Battery Orientation... 3-19 Battery Compartment Locations... 3-20 Battery serial number... 3-23 Flex Arm Installation... 3-24 Bracket Installation on Rail... 3-26 Humidifier Installation to Ventilator... 3-27 Service Mode Button (TEST)... 3-31 Flow Sensor Requires Calibration... 3-47 Calibrate The Flow Sensor... 3-48 Waiting to Begin Calibration and Calibration Test Setup... 3-48 Successful Calibration... 3-49 SST Prompts... 3-49 Areas of the GUI... 4-3 Pushpin Icon... 4-4 New Patient Settings... 4-8 Open Menu Tab... 4-10 New Patient setup Screen... 4-10 Apnea Setup Screen... 4-14 Alarms Settings Screen... 4-15

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List of Figures Figure 4-8. Figure 4-9. Figure 4-10. Figure 4-11. 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.

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Alarm Screen During Operation... 4-16 Vent Setup Button-“NIV” Indicating NIV Ventilation Type... 4-22 2TI SPONT Indicator... 4-23 Default NIV Alarm Settings... 4-24 RM in Menu Tab... 4-25 Respiratory Maneuver Tabs... 4-26 More Settings Screen with O2 Sensor Enabled... 4-29 Incompatible USB Device Message... 5-3 Comm Setup Screen... 5-4 Port Locations... 5-17 Alarm Message Format... 6-5 EVQ... 7-7 EVQ Components... 7-8 EVQ Removal... 7-8 Exhalation Valve Diaphragm Removal... 7-9 Exhalation Filter Seal Removal... 7-9 Pressure Sensor Filter Removal... 7-10 Immersion Method... 7-11 EVQ Reprocessing Kit... 7-13 Installing the Pressure Sensor Filter... 7-13 Installing the Exhalation Filter Seal... 7-14 Installing the Diaphragm... 7-14 Installing the EVQ... 7-15 Log Screen... 8-4 Ventilator with Accessories... 9-2 Additional Accessories... 9-2 Inspiration Using Pressure Sensitivity... 10-5 Inspiration Using Flow Sensitivity... 10-6 Breath Activity During Time-triggered Inspiration... 10-7 Exhalation via the Airway Pressure Method... 10-8 Typical Flow-cycled breath... 10-9 Square Flow Pattern... 10-10 Descending Ramp Flow Pattern... 10-11 Ideal Waveform Using Square Flow Pattern... 10-14 Ideal Waveform Using Descending Ramp Flow Pattern... 10-15 Ideal Waveform Using Pressure Control Ventilation... 10-16 ET Tube Target Pressure vs. Flow... 10-24 Tracheostomy Tube Target Pressure vs. Flow... 10-25 No Patient Inspiratory Effort Detected... 10-26 Patient Inspiratory Effort Detected... 10-26 Combined VIM and PIM Breaths... 10-27 Mandatory and Spontaneous Intervals... 10-28 PIM Delivered Within Mandatory Interval... 10-28

Operator’s Manual

List of Figures Figure 10-18. Figure 10-19. 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.

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PIM Not Delivered Within Mandatory Interval... 10-29 Apnea Interval Equals Breath Period... 10-34 Apnea Interval Greater Than Breath Period... 10-34 Apnea Interval Less Than Breath Period... 10-34 Apnea Ventilation in SIMV... 10-36 Spontaneous Breathing at PL... A-1 BiLevel Mode... A-2 BiLevel Setup Screen... A-3 BiLevel with Pressure Support... A-5 Spontaneous and Synchronous Intervals... A-7 APRV With Spontaneous Breathing at PH... A-8 Enabling Leak Sync... B-3 GUI Screen when Leak Sync is Enabled... B-4 Leak Sync Monitored Patient Data... B-5 Circuit Disconnect During VC... B-7 Ventilator Setup Screen... C-4 Graphics displays in PAV+™... C-10 Use of Default Lung Resistance... C-17 Installing the Neonatal Filter and Door... D-3 How to Connect the Breathing Circuit... D-6 CPAP Setup Screen... D-9 Proximal Flow Sensor... E-4 Sample GUI screen Showing Proximal Flow Data... E-5 Message During Autozero and Purge Processes... E-7 Attaching Proximal Flow Sensor to Ventilator... E-9 Enabling/Disabling the Proximal Flow Sensor... E-10 Attaching the Proximal Flow Sensor... E-11 Manual Purge... E-12 Alarm Message-Prox Inoperative... E-13 Accessing Trending via the Menu Tab... F-2

Operator’s Manual

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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 9-1. Table 10-1. Table 10-2.

Operator’s Manual

Shipping Carton Symbols and Descriptions... 1-2 Safety Symbol Definitions... 1-3 Typical Packing List... 2-4 BDU Front Label Symbols and Descriptions... 2-8 BDU Rear Label or Panel Symbols and Descriptions... 2-9 Common Symbols Found on GUI or BDU Labels... 2-11 GUI Control Keys... 2-15 GUI Visual Indicators... 2-17 Symbols and Abbreviations... 2-19 GUI Audible Indicator Functions... 2-23 Status Display Indicators and Descriptions... 2-27 BDU Audible Indicator Functions... 2-33 Color Legend... 2-34 Patient Types and PBW Values... 3-14 Ventilator Configuration... 3-32 SST Tests... 3-44 Humidifier Volumes-Adult and Pediatric Patients... 3-44 Humidifier Volumes-Neonatal Patients... 3-45 SST Test Step Results... 3-45 Overall SST Outcomes... 3-46 EST Tests... 3-53 EST Test Step Results... 3-54 Overall EST Outcomes... 3-55 Gestures and Their Meanings... 4-6 Allowable Ventilator Settings... 4-12 Setting Up a Patient for NIV... 4-20 Invasive to NIV on Same Patient... 4-21 NIV to Invasive on Same Patient... 4-22 MISCA Response... 5-6 MISCF Response... 5-10 Alarm Descriptions and Symbols... 6-6 Alarm Priority... 6-14 Technical Alarm Categories... 6-15 Technical Alarms... 6-16 Non-technical Alarm Summary... 6-16 Non-Technical Alarms and Suggested Responses... 6-26 Operator Preventive Maintenance Frequency... 7-1 Surface Cleaning Agents... 7-4 Component Cleaning Agents and Disinfection Procedures... 7-5 Service Preventive Maintenance Frequency... 7-16 Accessories and Options... 9-3 Compliance Volume Factors... 10-13 Maximum Pressure Adjustments... 10-17

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List of Tables 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 10-11. 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 B-1. Table B-2. Table C-1. Table C-2. Table C-3. Table D-1. Table D-2. Table D-3. Table D-4. Table D-5. Table D-6. Table E-1. Table E-2. Table E-3.

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Spontaneous Breath Delivery Characteristics... 10-19 Maximum Pressure Adjustments... 10-21 Inspiratory and Expiratory Pause Events... 10-41 Values for VT Based on Circuit Type... 10-47 Peak Flow and Circuit Type (Leak Sync Disabled)... 10-48 Modes and Breath Types... 10-49 Illustrated Modes and Breath Types... 10-49 Safety PCV Settings... 10-59 Inspiratory Backup Ventilation Settings... 10-62 Performance Verification Equipment Uncertainty... 11-1 Physical Characteristics... 11-2 Pneumatic Specifications... 11-3 Technical Specifications... 11-3 Electrical Specifications... 11-5 RS-232 Pinout... 11-5 Nurse Call Pinout... 11-6 Environmental Specifications... 11-6 Ventilator Settings Range and Resolution... 11-7 Alarm Settings Range and Resolution... 11-14 Patient Data Range and Resolution... 11-16 Delivery Accuracy... 11-22 Monitoring (Patient Data) Accuracy... 11-23 Computed Value Accuracy... 11-24 Electromagnetic Emissions... 11-26 Electromagnetic Immunity... 11-26 Immunity to Proximity Fields RF Wireless Communications Equipment... 11-29 AIM Standard Test Levels... 11-29 Recommended Separation Distances for RF... 11-30 Recommended Cables... 11-31 Maximum Leak Compensation Flow Based on Patient Type... B-2 DSENS Settings... B-5 Absolute limits for PAV+™ Monitored Data... C-7 PAV+™ Work of Breathing Terms... C-10 Default PBW-based Resistance Values... C-18 Recommended Breathing Circuits... D-7 Allowable NeoMode Ventilator Settings and Ventilation Type... D-7 Humidifier Volumes-Neonatal Patients... D-8 Delivered Volume Accuracy...D-11 Monitored Inspired Volume (VTI) Accuracy...D-11 Monitored Exhaled Tidal Volume (VTE) Accuracy...D-11 Proximal Flow Option Patient Data Symbols... E-5 Proximal Flow Option SST tests... E-7 Proximal Flow Sensor Volume Accuracy... E-13

Operator’s Manual

List of Tables Table E-4. Table E-5. Table F-1. Table F-2. Table F-3. Table F-4.

Operator’s Manual

Proximal Flow Sensor Specifications... E-14 Proximal Flow Option Component Part Numbers... E-14 Trended Ventilator Settings... F-3 Trended Patient Data Parameters... F-4 Sampling Periods for Selected Time Scales... F-7 Events... F-8

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