800 Series Ventilator Operators and Technical Reference Manual Rev G Oct 2016

Table of Contents Operator’s Manual OP 1

Introduction

OP 1.1 Overview...OP 1-1 OP 1.2 Indications for Use...OP 1-2 OP 1.3 Technical Description...OP 1-2 OP 1.3.1 General Background... OP 1-2 OP 1.3.2 Pressure and Flow Triggering... OP 1-3 OP 1.3.3 Breathing Gas Mixture... OP 1-4 OP 1.3.4 Inspiratory Pneumatics... OP 1-4 OP 1.3.5 Patient Circuit... OP 1-5 OP 1.3.6 AC Mains and Backup Power System... OP 1-5 OP 1.3.7 Ventilator Emergency States... OP 1-6 OP 1.4 Graphic User Interface...OP 1-6 OP 1.5 User Interface Controls and Indicators...OP 1-8 OP 1.5.1 Onscreen Symbols and Abbreviations... OP 1-12 OP 1.6 Ventilator System Labeling Symbols...OP 1-16 OP 2

How to Set up the Puritan Bennett™ 840 Ventilator

OP 2.1 Overview...OP 2-1 OP 2.2 Connecting the Electrical Supply...OP 2-3 OP 2.3 Connecting the Air and Oxygen Supplies...OP 2-8 OP 2.4 Connecting the Patient Circuit Components...OP 2-10 OP 2.4.1 Selecting and Connecting a Patient Circuit... OP 2-11 OP 2.4.2 Installing the Expiratory Filter and Collector Vial... OP 2-13 OP 2.4.3 Installing the Flex Arm... OP 2-15 OP 2.4.4 Installing the Humidifier... OP 2-18 OP 2.4.5 Using the Ventilator Cart... OP 2-19 OP 3

How to Run Short Self Test (SST)

OP 3.1 Overview...OP 3-1 OP 3.2 Introduction to SST...OP 3-1 OP 3.3 When to Run SST...OP 3-2 OP 3.4 SST Components and Requirements...OP 3-2 OP 3.5 SST Procedure...OP 3-3 OP 3.6 SST Results...OP 3-8 OP 3.6.1 Interpreting Individual SST Test Results... OP 3-9 OP 3.6.2 SST Outcomes... OP 3-9

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OP 4

How to use the Puritan Bennett™ 840 Ventilator

OP 4.1 Overview... OP 4-1 OP 4.2 Structure of the User Interface... OP 4-2 OP 4.3 Patient Setup... OP 4-3 OP 4.3.1 Ventilating With the Most Recent Control Parameters... OP 4-4 OP 4.3.2 Ventilating With New Control Parameters... OP 4-4 OP 4.3.3 Patient Data and Current Settings... OP 4-7 OP 4.3.4 Other Changes... OP 4-9 OP 4.4 Changing the Main Ventilator Control Parameters... OP 4-11 OP 4.5 Other Changes... OP 4-12 OP 4.6 Constant Timing Variable During Rate Changes... OP 4-13 OP 4.7 Changing Apnea Ventilation Settings... OP 4-14 OP 4.8 Setting Alarms... OP 4-14 OP 4.9 Changing Other Settings... OP 4-16 OP 4.10 Expiratory Pause Maneuvers... OP 4-17 OP 4.11 Inspiratory Pause Maneuvers... OP 4-18 OP 4.12 Interpreting Pause Maneuver Results... OP 4-19 OP 4.13 Using NIV... OP 4-20 OP 4.13.1 NIV Intended Use... OP 4-20 OP 4.13.2 NIV Breathing Interfaces... OP 4-20 OP 4.13.3 NIV Setup... OP 4-21 OP 4.13.4 High Spontaneous Inspiratory Time Limit... OP 4-23 OP 4.13.5 Apnea Setup... OP 4-24 OP 4.13.6 Alarm Setup... OP 4-24 OP 4.13.7 Changing from Invasive to NIV Vent Type... OP 4-25 OP 4.13.8 Changing from NIV to Invasive Vent Type... OP 4-25 OP 4.13.9 NIV Patient Data... OP 4-26 OP 5 OP 5.1 OP 5.2 OP 5.3 OP 5.4 OP 5.5 OP 5.6 OP 5.7 OP 6 OP 6.1 OP 6.2 OP 6.3 OP 6.4

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How to Handle Alarms Overview... OP 5-1 Ventilator Alarm Classifications... OP 5-1 Alarm Silence... OP 5-2 Alarm Reset... OP 5-3 Alarm Log... OP 5-4 Alarm Volume... OP 5-5 Alarm Messages... OP 5-6 How to View Graphics Overview... OP 6-1 Graphics Display Function... OP 6-1 How to Set Up a Graphics Display... OP 6-3 Graphics Display Details and Calculations... OP 6-3

OP 6.5 OP 6.6 OP 6.7 OP 6.8 OP 6.9 OP 7

How to Adjust Displayed Graphics...OP 6-4 The Graphics Display FREEZE Function...OP 6-4 How to Print Patient Data Graphics...OP 6-4 Automatic Display of Graphics...OP 6-5 When Graphics are not Accessible...OP 6-5 Preventive Maintenance

OP 7.1 Overview...OP 7-1 OP 7.2 How to Dispose of Used Parts...OP 7-1 OP 7.3 How to Clean, Disinfect, and Sterilize Parts...OP 7-1 OP 7.3.1 How to Clean Components... OP 7-4 OP 7.4 Disinfection and Sterilization...OP 7-4 OP 7.5 Preventive Maintenance Procedures for the Operator...OP 7-6 OP 7.5.1 Total Operational Hours... OP 7-6 OP 7.5.2 Inspiratory and Expiratory Bacteria Filters... OP 7-8 OP 7.5.3 Daily or as Required: Collector Vial and Drain Bag... OP 7-9 OP 7.5.4 Daily or as Required: In-line Water Traps... OP 7-10 OP 7.5.5 Every 250 Hours: Compressor Inlet Filter... OP 7-10 OP 7.5.6 Every Year: Ventilator Inspection... OP 7-11 OP 7.6 Additional Preventive Maintenance Procedures...OP 7-16 OP 7.7 Storage...OP 7-17 OP 7.8 Repacking and Shipping...OP 7-17 OP A

Specifications

OP A.1 Overview...OP A-1 OP A.2 Physical Characteristics...OP A-1 OP A.3 Environmental Requirements...OP A-2 OP A.4 Pneumatic Specifications...OP A-3 OP A.5 Electrical Specifications...OP A-4 OP A.6 Compliance and Approvals...OP A-5 OP A.6.1 Manufacturer’s Declaration... OP A-7 OP A.7 Technical Specifications... OP A-11 OP A.8 Patient Circuit Configurations... OP A-14 OP A.9 Ranges, Resolutions, and Accuracies... OP A-15 OP A.9.1 Recommended Limits... OP A-15 OP A.9.2 Software Options... OP A-15 OP B

Part Numbers

OP B.1

Overview

...OP B-1

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OP C

Pneumatic Schematic

OP C.1 OP D

Overview

Alarm and Oxygen Sensor Calibration Testing

OP D.1 OP D.2 OP D.3 OP E

... OP C-1

Overview...OP D-1 Alarm Test...OP D-1 Oxygen Sensor Calibration Test...OP D-6 Remote Alarm and RS-232 Ports

OP E.1 Overview... OP E-1 OP E.2 Remote Alarm Port... OP E-2 OP E.3 RS-232 Port... OP E-2 OP E.4 How to Configure the RS-232 Ports... OP E-3 OP E.5 Printers and Cables... OP E-4 OP E.5.1 Printers... OP E-4 OP E.5.2 Cables... OP E-4 OP E.6 RS-232 Port Commands... OP E-5 Technical Reference TR 1

Introduction to Breath Delivery

TR 1.1 TR 2

Overview... TR 1-1 Detecting and Initiating Inspiration

TR 2.1 TR 2.2 TR 2.2.1 TR 2.2.2 TR 2.2.3 TR 2.3 TR 3

Detecting and Initiating Exhalation

TR 3.1 TR 3.2 TR 3.2.1 TR 3.2.2 TR 3.2.3 TR 3.3 TR 3.3.1

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Overview... TR 2-1 Internally Triggered Inspiration... TR 2-1 Pressure Sensitivity... TR 2-2 Flow Sensitivity... TR 2-3 Time-cycled Inspiration... TR 2-4 Operator-triggered Inspiration... TR 2-5

Overview... TR 3-1 Internally Initiated Exhalation... TR 3-1 Time-cycled Exhalation... TR 3-1 End Inspiratory Flow Method... TR 3-1 Airway Pressure Method... TR 3-2 Backup Limits... TR 3-3 Time Limit... TR 3-3

TR 3.3.2 High Circuit Pressure Limit... TR 3-3 TR 3.3.3 High Ventilator Pressure Limit... TR 3-4 TR 4 TR 4.1 TR 4.2 TR 4.3 TR 4.4 TR 4.5 TR 5 TR 5.1 TR 6 TR 6.1 TR 6.2 TR 6.3 TR 6.4 TR 7 TR 7.1 TR 7.2 TR 7.3 TR 7.4 TR 7.5 TR 8 TR 8.1 TR 8.2 TR 8.3 TR 9 TR 9.1 TR 9.2 TR 9.3 TR 9.4 TR 9.5 TR 9.6 TR 9.7

Mandatory Breath Delivery Overview... TR 4-1 Comparison of Pressure- and Volume-based Mandatory Breaths... TR 4-1 Compliance Compensation for Volume-based Mandatory Breaths... TR 4-3 BTPS Compensation for Volume-based Mandatory Breaths... TR 4-4 Manual Inspiration... TR 4-4 Spontaneous Breath Delivery Overview

... TR 5-1

Assist/control (A/C) Mode Overview... TR 6-1 Breath Delivery in A/C... TR 6-1 Rate change During A/C... TR 6-2 Changing to A/C Mode... TR 6-3 Synchronized Intermittent Mandatory Ventilation Overview... TR 7-1 Breath Delivery in SIMV... TR 7-2 Apnea Ventilation in SIMV... TR 7-3 Changing to SIMV Mode... TR 7-4 Rate Change During SIMV... TR 7-6 Spontaneous (SPONT) Mode Overview... TR 8-1 Breath Delivery in SPONT... TR 8-1 Changing to SPONT Mode... TR 8-1 Apnea Ventilation Overview... TR 9-1 Apnea Detection... TR 9-1 Transition to Apnea Ventilation... TR 9-3 Key Entries During Apnea Ventilation... TR 9-3 Resetting Apnea Ventilation... TR 9-3 Resetting to A/C... TR 9-4 Resetting to SIMV... TR 9-4

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TR 9.8 TR 9.9 TR 10 TR 10.1 TR 10.2 TR 10.3 TR 10.4 TR 11 TR 11.1 TR 12 TR 12.1 TR 12.2 TR 12.3 TR 12.4 TR 12.5 TR 12.6 TR 12.7 TR 12.8 TR 12.9 TR 12.10 TR 12.11 TR 12.12 TR 12.13 TR 12.14 TR 12.15 TR 12.16 TR 12.17 TR 12.18 TR 12.19 TR 12.20 TR 12.21 TR 12.22 TR 12.23 TR 12.24 TR 12.25 TR 12.26 TR 12.27 TR 12.28

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Resetting to SPONT... TR 9-4 Phasing in New Apnea Intervals... TR 9-4 Detecting Occlusion and Disconnect Overview... TR 10-1 Occlusion... TR 10-1 Disconnect... TR 10-2 Occlusions and Disconnect Annunciation... TR 10-4 Phasing in Setting Changes Overview... TR 11-1 Ventilator Settings Overview... TR 12-1 Apnea Ventilation... TR 12-1 Circuit Type and IBW... TR 12-2 Disconnect Sensitivity... TR 12-2 Expiratory Sensitivity... TR 12-3 Expiratory Time... TR 12-3 Flow Pattern... TR 12-3 Flow Sensitivity... TR 12-4 High Spontaneous Inspiratory Time Limit... TR 12-4 Humidification Type... TR 12-5 I:E Ratio... TR 12-5 Ideal Body Weight... TR 12-5 Inspiratory Pressure... TR 12-5 Inspiratory Time... TR 12-6 Mode and mandatory Breath Type... TR 12-6 O2%... TR 12-8 Peak Inspiratory Flow... TR 12-9 PEEP... TR 12-9 PEEP Restoration... TR 12-10 Plateau Time... TR 12-10 Pressure Sensitivity... TR 12-10 Pressure Support... TR 12-10 Respiratory Rate... TR 12-11 Rise Time%... TR 12-11 Safety Ventilation... TR 12-12 Spontaneous Breath Type... TR 12-13 Tidal Volume... TR 12-13 Vent Type... TR 12-14

TR 13

Alarms

TR 13.1 Overview... TR 13-1 TR 13.2 Alarm Handling... TR 13-1 TR 13.2.1 Alarm messages...TR 13-2 TR 13.2.2 Alarm Summary...TR 13-4 TR 13.3 AC POWER LOSS Alarm...TR 13-15 TR 13.4 APNEA Alarm...TR 13-15 TR 13.5 CIRCUIT DISCONNECT Alarm...TR 13-15 TR 13.6 DEVICE ALERT Alarm...TR 13-16 TR 13.7 HIGH CIRCUIT PRESSURE Alarm...TR 13-16 TR 13.8 HIGH DELIVERED O2% Alarm...TR 13-17 TR 13.9 HIGH EXHALED MINUTE VOLUME Alarm...TR 13-17 TR 13.10 HIGH EXHALED TIDAL VOLUME Alarm...TR 13-17 TR 13.11 HIGH INSPIRED TIDAL VOLUME Alarm...TR 13-18 TR 13.12 HIGH RESPIRATORY RATE Alarm...TR 13-18 TR 13.13 INSPIRATION TOO LONG Alarm...TR 13-18 TR 13.14 LOW CIRCUIT PRESSURE Alarm...TR 13-19 TR 13.15 LOW DELIVERED O2% Alarm...TR 13-19 TR 13.16 LOW EXHALED MANDATORY TIDAL VOLUME Alarm...TR 13-20 TR 13.17 LOW EXHALED SPONTANEOUS TIDAL VOLUME Alarm...TR 13-20 TR 13.18 LOW EXHALED TOTAL MINUTE VOLUME Alarm...TR 13-21 TR 13.19 PROCEDURE ERROR Alarm...TR 13-21 TR 14 TR 14.1 TR 14.2 TR 14.3 TR 14.4 TR 14.5 TR 14.6 TR 14.7 TR 14.8 TR 14.9 TR 14.10 TR 14.11 TR 14.12 TR 14.13 TR 14.14 TR 15 TR 15.1 TR 15.2

Patient Data Overview... TR 14-1 Delivered O2%... TR 14-1 End Expiratory Pressure... TR 14-1 End Inspiratory Pressure... TR 14-2 Exhaled Minute Volume... TR 14-2 Exhaled Tidal Volume... TR 14-3 I:E Ratio... TR 14-4 Intrinsic (auto) PEEP and Total PEEP... TR 14-4 Mean Circuit Pressure... TR 14-4 Peak Circuit Pressure... TR 14-4 Plateau Pressure... TR 14-5 Spontaneous Minute Volume... TR 14-5 Static Compliance and Resistance... TR 14-5 Total Respiratory Rate... TR 14-9 Safety Net Overview... TR 15-1 Patient Problems... TR 15-1

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TR 15.3 TR 15.4 TR 15.5 TR 15.6 TR 15.7 TR 15.8 TR 15.9 TR 15.10 TR 15.11 TR 15.12 TR 15.13 TR 16 TR 16.1 TR 16.2 TR 16.3 TR 16.4 TR 16.5 TR 16.6 TR 16.7 TR 17 TR 17.1 TR 17.2 TR 17.3 TR 18 TR 18.1 TR 18.2 TR 18.3 TR 18.4 TR 18.5 TR 19 TR 19.1 TR 19.2 TR 19.3 Glossary Index

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System Faults... TR 15-1 Ongoing Background Checks... TR 15-2 Hardware Monitoring Circuitry... TR 15-3 Power On Self Test (POST)... TR 15-4 Short Self Test (SST)... TR 15-4 Extended Self Test (EST)... TR 15-4 Oxygen Sensor Calibration... TR 15-4 Exhalation Valve Calibration... TR 15-5 Ventilator Inoperative Test... TR 15-5 Flow Sensor Offset Calibration... TR 15-5 Atmospheric Pressure Transducer Calibration... TR 15-5 Power on Self Test (POST) Overview... TR 16-1 Safety... TR 16-1 POST Characteristics... TR 16-1 POST Following Power Interruptions... TR 16-3 POST Fault Handling... TR 16-3 POST System Interface... TR 16-3 POST User Interface... TR 16-4 Short Self Test (SST) Overview... TR 17-1 SST Results... TR 17-1 SST Failure Handling... TR 17-2 Extended Self Test (EST) Overview... TR 18-1 EST Functions... TR 18-1 EST Results... TR 18-1 EST Failure Handling... TR 18-2 EST Safety Considerations... TR 18-3 RS-232 Commands Overview... TR 19-1 SNDA Command... TR 19-1 SNDF Command... TR 19-5

List of Figures Operator’s Manual Figure OP 1-1. Puritan Bennett™ 840 Ventilator System Block Diagram... OP 1-3 Figure OP 1-2. Puritan Bennett™ 840 Ventilator System GUI... OP 1-7 Figure OP 2-1. How to Lift the Ventilator Components... OP 2-2 Figure OP 2-2. How to Connect the Ventilator Power Cord... OP 2-4 Figure OP 2-3. Ventilator Power Switch, AC Indicator, and AC Panel... OP 2-5 Figure OP 2-4. Power Cord Storage on the RTA Cart... OP 2-7 Figure OP 2-5. Power Cord Storage on the Newer Compressor Mount Cart and Pole Cart (shown)... OP 2-8 Figure OP 2-6. How to Connect the Air and Oxygen Supplies...OP 2-10 Figure OP 2-7. How to Connect the Patient Circuit...OP 2-12 Figure OP 2-8. How to Install the Expiratory Filter and Collector Vial...OP 2-13 Figure OP 2-9. How to Use the Collector Vial With or Without the Drain Bag...OP 2-14 Figure OP 2-10. How to Install the Flex Arm on the RTA Cart...OP 2-16 Figure OP 2-11. How to Install the Flex Arm on the Newer Compressor Mount Cart or Pole Cart...OP 2-17 Figure OP 2-12. How to Install the Humidifier (Fisher & Paykel™* version shown) for Ventilators Mounted on RTA Carts...OP 2-19 Figure OP 2-13. Location of Cart Lot Number Label...OP 2-20 Figure OP 2-14. How to Lock and Unlock the RTA Cart’s Front Wheels...OP 2-21 Figure OP 2-15. How to Lock and Unlock the Compressor Mount Cart or Pole Cart Front Wheels... OP 2-21 Figure OP 3-1. Test Button Location... OP 3-4 Figure OP 4-1. Touch Screen User Interface... OP 4-2 Figure OP 4-2. Ventilator Startup Screen... OP 4-3 Figure OP 4-3. Touch Screen Appearance During Normal Ventilation (shown with alarm silence and 100% O2/CAL in progress)... OP 4-8 Figure OP 4-4. TI (or TH) Selected as the Constant During Rate Change...OP 4-13 Figure OP 4-5. Alarm Setup...OP 4-15 Figure OP 4-6. New Patient Setup Screen-NIV...OP 4-21 Figure OP 4-7. NIV Ventilator Settings Screen...OP 4-23 Figure OP 4-8. New Patient Default Alarm Settings...OP 4-24 Figure OP 4-9. More Patient Data Screen - NIV...OP 4-26 Figure OP 5-1. Alarm Indicators... OP 5-1 Figure OP 5-2. Alarm Silence in Progress Indicator (lower screen)... OP 5-3 Figure OP 5-3. Alarm log... OP 5-4 Figure OP 5-4. Alarm Message Format... OP 5-6 Figure OP 6-1. Pressure-volume Loop... OP 6-2 Figure OP 6-2. Flow-volume Loop... OP 6-2 Figure OP 7-1. How to Empty the Collector Vial and Seal the Drain Bag...OP 7-10 Figure OP 7-2. 806 Compressor with Inlet Filter...OP 7-11 Figure OP 7-3. Dislodge the O2 Sensor Access Cover...OP 7-13 Figure OP 7-4. Open O2 Sensor Access Port...OP 7-14 Figure OP 7-5. Locate O2 Sensor...OP 7-14 Figure OP A-1. Heated Wire Configuration... OP A-14

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Figure OP A-2. Non-heated Wire Configuration... OP A-14 Figure OP B-1. Ventilator Accessories... OP B-2 Figure OP B-2. Ventilator Accessories (compressor mount cart shown)... OP B-6 Figure OP B-3. Puritan Bennett™ 840 Ventilator System Shown Mounted on Puritan Bennett™ 800 Series Ventilator Pole Cart...OP B-10 Figure OP C-1. Pneumatic Schematic...OP C-2 Figure OP E-1. Remote Alarm and RS-232 Ports... OP E-1 Figure OP E-2. Remote Alarm Pinout (view from back of GUI)... OP E-2 Figure OP E-3. RS-232 Serial Port Pinout... OP E-3 Technical Reference Figure TR 2-1. Declaring Inspiration Using Pressure Sensitivity... TR 2-2 Figure TR 2-2. Declaring Inspiration Using Flow Sensitivity... TR 2-3 Figure TR 2-3. Time-cycled Inspiration... TR 2-4 Figure TR 3-1. Initiating Exhalation using the End-inspiratory Flow Method... TR 3-2 Figure TR 3-2. Initiating Exhalation using the Airway Pressure Method... TR 3-3 Figure TR 6-1. A/C Mode, No Patient Effort Detected... TR 6-2 Figure TR 6-2. A/C Mode, Patient Effort Detected... TR 6-2 Figure TR 6-3. A/C Mode, VIM and PIM Breaths... TR 6-2 Figure TR 7-1. SIMV Breath Cycle (mandatory and spontaneous intervals)... TR 7-1 Figure TR 7-2. SIMV Breath Cycle, PIM Delivered Within Mandatory Interval... TR 7-2 Figure TR 7-3. SIMV Breath Cycle, PIM Not Delivered Within Mandatory Interval... TR 7-2 Figure TR 7-4. Apnea Ventilation in SIMV... TR 7-4 Figure TR 9-1. Apnea Interval Equals Breath Period... TR 9-2 Figure TR 9-2. Apnea Interval Greater than Breath Period... TR 9-2 Figure TR 9-3. Apnea Interval Less than Breath Period... TR 9-2 Figure TR 13-1. Alarm messages format (upper GUI screen)... TR 13-3

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List of Tables Operator’s Manual Table OP 1-1. Table OP 1-2. Table OP 1-3. Table OP 1-4. Table OP 2-1. Table OP 3-1. Table OP 3-2. Table OP 3-3. Table OP 4-1. Table OP 4-2. Table OP 4-3. Table OP 4-4. Table OP 4-5. Table OP 4-6. Table OP 5-1. Table OP 7-1. Table OP 7-2. Table OP 7-3. Table OP 7-4. Table OP A-1. Table OP A-2. Table OP A-3. Table OP A-4. Table OP A-5. Table OP A-6. Table OP A-7. Table OP A-8. Table OP A-9.

Puritan Bennett™ 840 Ventilator System GUI Controls and Indicators... OP 1-8 BDU Indicators...OP 1-11 Puritan Bennett™ 840 Ventilator System Symbols and Abbreviations...OP 1-13 Labeling Symbols...OP 1-16 Patient circuit and IBW values...OP 2-12 SST Test Sequence... OP 3-6 Individual SST Test Results... OP 3-9 Overall SST Outcomes...OP 3-10 Ideal Body Weight (IBW) Based on Patient Height... OP 4-9 Soft Bound Ranges for Ideal Body Weight (IBW) and Tube Internal Diameter (ID)...OP 4-10 Patient Circuit and IBW Values...OP 4-11 Monitored Ventilator Control Parameters...OP 4-11 Automatic Settings Changes-Invasive to NIV on the Same Patient...OP 4-25 Automatic Settings Changes-NIV to Invasive on the Same Patient...OP 4-25 Alarm Messages... OP 5-7 Procedures to Clean, Disinfect, and Sterilize Parts... OP 7-2 Disinfection and Sterilization Procedures... OP 7-5 Operator Preventive Maintenance Procedures and Frequency... OP 7-6 Service Preventive Maintenance Procedures and Intervals...OP 7-16 Physical Characteristics...OP A-1 Environmental Requirements...OP A-2 Pneumatic Specifications...OP A-3 Electrical Specifications...OP A-4 Compliance and Approvals...OP A-6 Electromagnetic Emissions...OP A-7 Electromagnetic Immunity...OP A-8 Electromagnetic Immunity-Conducted and Radiated RF...OP A-9 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Puritan Bennett™ 840 Ventilator System... OP A-10 Table OP A-10. Compliant Cables... OP A-11 Table OP A-11. Technical Specifications... OP A-11 Table OP A-12. Ventilator Settings... OP A-16 Table OP A-13. Alarm Settings... OP A-28 Table OP A-14. Patient Data... OP A-31 Table OP A-15. Other Screens-Displayed Data... OP A-36 Table OP B-1. Ventilator Parts and Accessories... OP B-2 Table OP B-2. Ventilator Parts and Accessories... OP B-6 Table OP B-3. Ventilator Pole Cart and Accessories...OP B-10 Table OP C-1. Pneumatic Components...OP C-3

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Technical Reference Table TR 4-1. Table TR 4-2. Table TR 5-1. Table TR 12-1. Table TR 12-2. Table TR 13-1. Table TR 13-2. Table TR 13-3. Table TR 13-4. Table TR 14-1. Table TR 19-1. Table TR 19-2.

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Comparison of Pressure- and Volume-based Mandatory Breaths... TR 4-2 Compliance Volume Factors... TR 4-4 Spontaneous Breath Delivery Characteristics... TR 5-1 Puritan Bennett™ 840 Ventilator Modes and Breath Types... TR 12-7 Illustrated Modes and Breath Types... TR 12-8 Alarm Priority Levels... TR 13-2 Alarm Summary... TR 13-4 Loss of GUI Display... TR 13-14 Applicability of High Inspired Tidal Volume Alarm Symbols... TR 13-18 Inspiratory Pause Maneuver Displays... TR 14-7 MISCA Response... TR 19-2 MISCF Response... TR 19-6

Applicability The information in this manual applies to Puritan Bennett™ 840 Ventilator versions manufactured or updated after August 2005. Some of this information may not apply to earlier versions. Contact your Covidien representative if in doubt. Definitions This manual uses three special indicators to convey information of a specific nature:

  

WARNING: Indicates a condition that can endanger the patient or the ventilator operator. Caution: Indicates a condition that can damage the equipment. Note: Indicates points of particular emphasis that make operation of the ventilator more efficient or convenient.

Warnings, Cautions, and Notes Take the time to familiarize yourself with the safety considerations listed in this section, special handling requirements, and regulations that govern the use of the ventilator system.

    

WARNING: The 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. WARNING: The user of this product shall have sole responsibility for any ventilator malfunction due to operation or maintenance performed by anyone not trained by Covidien. WARNING: To ensure proper servicing and avoid the possibility of physical injury, only qualified personnel should attempt to service or make authorized modifications to the ventilator. WARNING: To avoid an electrical shock hazard while servicing the ventilator, be sure to remove all power to the ventilator by disconnecting the power source and turning off all ventilator power switches. WARNING: To avoid a fire hazard, keep matches, lighted cigarettes, and all other sources of ignition (e.g., flammable anesthetics or heaters) away from the ventilator system and oxygen hoses.

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WARNING: Do not use oxygen hoses that are worn, frayed, or contaminated by combustible material such as grease or oils. Textiles, oils, and other combustibles are easily ignited and burn with great intensity in oxygen-enriched air. WARNING: In case of fire or a burning smell, immediately disconnect the ventilator from the oxygen supply, the facility power, and the backup power source. WARNING: When handling any part of the ventilator system, always follow your hospital guidelines for handling infectious material. WARNING: Covidien recognizes cleaning, sterilization, sanitation, and disinfection practices vary widely among health care institutions. It is not possible for Covidien to specify or require specific practices that will meet all needs, or to be responsible for the effectiveness of cleaning, sterilization, and other practices carried out in the patient care setting. As a manufacturer, Covidien does not have any guidelines or recommendations regarding specific pathogens as they relate to the usage of our products. In regards to transmission of any specific pathogen, Covidien can offer the specifications of our products as well as our recommendations for cleaning and sterilization. Any further clarification regarding pathogens as they relate to our products should be brought to the attention of your lab pathologist as well as your infection control personnel or your risk committee. WARNING: Patients on life-support equipment should be appropriately monitored by competent medical personnel and suitable monitoring devices. WARNING: The ventilator system is not intended to be a comprehensive monitoring device and does not activate alarms for all types of dangerous conditions for patients on life-support equipment. WARNING: For a thorough understanding of ventilator operations, be sure to thoroughly read this manual before attempting to use the system. 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. WARNING: An alternative source of ventilation should always be available when using the ventilator system.

Operator's and Technical Reference Manual

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WARNING: Check the ventilator periodically according to the Puritan Bennett™ 840 Ventilator System Service Manual; do not use if defective. Immediately replace parts that are broken, missing, obviously worn, distorted, or contaminated. WARNING: This ventilator offers a choice of breath delivery modes and types. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and breath type to use for that patient. This selection should be based on the clinician’s clinical judgment, considering the condition and needs of the individual patient, as such condition and needs change from time to time and considering the benefits, limitations, and operating characteristics of each mode and breath type. Caution: Do not use sharp objects to make selections on the graphical user interface (GUI) display or keyboard. Note: Items shown in bold font are physical hardware features (e.g., to patient port, from patient port). Note: U. S. federal law restricts this device to sale by or on the order of a physician.

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Warranty The ventilator system is warranted against defects in material and workmanship in accordance with the Covidien Medical Equipment Warranty supplied with your ventilator. Keep a maintenance record to ensure the validity of the warranty. Year of Manufacture The GUI and breath delivery unit (BDU), backup power source (BPS) and compressor contain a specific year of manufacture applicable for that assembly. The year of manufacture is indicated by the fifth and sixth digits of the serial number, which is located at the back panel of the GUI, BDU, and BPS, and the side panel of the compressor. Manufacturer Covidien llc 15 Hampshire Street Mansfield, MA 02408 USA

Electromagnetic Susceptibility The ventilator system complies with the requirements of IEC 60601-1-2:2004 (EMC Collateral Standard), including the E-field susceptibility requirements at a level of 10 volts per meter, at frequencies from 80 MHz to 2.5 GHZ, and with the ESD requirements of this standard. However, even at this level of device immunity, certain transmitting devices (cellular phones, twoway radios, cordless phones, paging transmitters, etc.) emit radio frequencies that could interrupt ventilator operation if operated in a range too close to the ventilator. It is difficult to determine when the field strength of these devices becomes excessive. Practitioners should be aware radio frequency emissions are additive, and the ventilator must be located a sufficient distance from transmitting devices to avoid interruption. Do not operate the ventilator in a magnetic resonance imaging (MRI) environment.



WARNING: Accessory equipment connected to the power receptacle, analog, and digital interfaces must be certified according to IEC 60601-1. Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the power receptacle, signal input part, or signal output part of the ventilator 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 contact your local Covidien representative.

This manual describes possible ventilator alarms and what to do if alarms occur. Consult with your institution’s biomedical engineering department in case of interrupted ventilator operation, and before relocating any life support equipment.

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Operator's and Technical Reference Manual

Customer assistance For further assistance call Covidien Technical Services at 1 800 255 6774 or contact your local Covidien representative. For online technical support, visit the SolvItSM 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 Covidien products 24 hours a day, 7 days a week.

Preface This manual is divided into two parts: the operator’s manual and the technical reference manual. The operator’s manual describes how to operate the ventilator system. It also provides product specifications and accessory order numbers. The technical reference manual includes background information about how the ventilator functions, including details on its operating modes, self-tests, and other features. In the table of contents, list of figures, list of tables, and index, the prefix OP- identifies page numbers, figure numbers, and table numbers in the operator’s manual, and the prefix TR- identifies the same items in the technical reference manual. Any references to the software options BiLevel, Volume Ventilation Plus (VV+) (which include VC+ and VS breath types), NeoMode, Proportional Assist™* Ventilation (PAV™*+), Tube Compensation (TC), Respiratory Mechanics (RM), and Trending in this manual assume that the option has been installed on the ventilator. If these options aren’t installed, then references to their functions do not apply. While this manual covers the ventilator configurations currently supported by Covidien, it may not be all-inclusive and may not be applicable to your ventilator. Within the USA, contact Covidien at 1 800 255 6774 for questions about the applicability of the information. Some illustrations and images are shown with a ready-to-assemble (RTA) cart, a Puritan Bennett™ 800 Series Ventilator Compressor Mount Cart, or a Puritan Bennett™ 800 Series Ventilator Pole Cart. Note that these images are for illustrative purposes only, and regardless of which cart you have, the required information is provided. The term “RTA cart” refers to the ready-to-assemble cart and any earlier cart versions.

Operator's and Technical Reference Manual

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Operator's and Technical Reference Manual

OP 1 Introduction

OP 1.1

Overview The intended use of the Puritan Bennett™ 840 Ventilator System is for acute and subacute care of infant, pediatric, and adult patients. Software options, available from Covidien, provide additional ventilation functions. The ventilator facilitates work of breathing management, offers selectable modes of breath delivery, and assists the practitioner in selecting the most appropriate ventilator control parameters for the patient. The user interface is intuitive and easy to operate for those with prior knowledge of ventilator operation. The user interface includes DualView touch screens that display monitored patient data for easy assessment of the patient’s condition. The touch screens also display the current ventilator control parameters. The SandBox area on the touch screen allows the practitioner to preview the selected ventilator control parameters prior to active patient ventilation. The SmartAlert system intercepts alarms, or events, provides specific information about the cause, and prompts the user with actions to resolve the reported conditions. The breath delivery unit (BDU) comprises the pneumatics and the patient circuit. The ventilator uses two independent central processing units (CPUs): •

Breath delivery (BD) CPU

•

Graphic user interface (GUI) CPU

The BD CPU uses the ventilator control parameters, selected by the practitioner, to deliver breaths to the patient. The BD CPU also runs continuous and extensive operational background checks to ensure proper operation of the ventilator. The GUI CPU monitors the ventilator and the ventilator/patient interaction. The GUI CPU also monitors the operation of the BD CPU and prevents simultaneous failure of control and monitor functions when a single fault is reported. The ventilator system supplies mandatory or spontaneous breaths with a preset level of positive end expiratory pressure (PEEP), trigger sensitivity, and oxygen concentration. A mandatory breath can either be pressure- or volume-controlled, but it is always pressure-controlled in the optional BiLevel mode. A spontaneous breath allows patient inspiratory flows of up to 200 L/ min, with or without pressure support.

OP 1-1