CARESCAPE R860 Users Reference Manual Sw Rev 10

User responsibility Datex-Ohmeda, Inc. a General Electric Company, doing business as GE Healthcare. This product will perform in conformity with the description thereof contained in this User’s Reference manual and accompanying labels and/or inserts, when assembled, operated, maintained, and repaired in accordance with the instruction provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. Should repair or replacement become necessary, Datex-Ohmeda recommends that a telephonic or written request for service advice be made to the nearest DatexOhmeda Customer Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Datex-Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be altered without the prior written approval of Datex-Ohmeda. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Datex-Ohmeda.

CAUTION

U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner.Outside the U.S.A., check the local laws for any restriction that may apply.

Table of Contents 1 Introduction Welcome... 1-2 Indications for use/Intended use... 1-2 Contraindications...1-2 Operational use... 1-2 Trademarks... 1-3 Serial numbers...1-3 General information... 1-4 Neonatal manual... 1-5

2 Symbols and abbreviations Abbreviations... 2-2 Symbols, safety and manual terms... 2-5 Symbols on the equipment... 2-5 Symbols on the user interface...2-7 Symbols on the packaging... 2-9

3 Navigation Ventilator display... 3-2 Display user interface... 3-4 Navigating active alarms... 3-5 Standby... 3-6 Main menu... 3-7 System menu...3-8 Changing a setting...3-9 Navigating the user interface... 3-11 Present/Patient Status workspace and views...3-12 Past/Historical Trends workspace and views... 3-15 Future/Clinical Decision Support workspace and views . . . 3-17

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4 Setup and connections General use and safety precautions... 4-3 Ventilator overview front... 4-5 Ventilator overview back... 4-6 Connecting power... 4-7 Connecting and removing the exhalation valve housing . . . 4-8 Connecting gas supplies... 4-9 Connecting the exhalation valve heater... 4-10 Connecting the accessory rail... 4-12 Attaching the rail adapter to the accessory rail...4-12 Attaching system accessories...4-13 Connecting the breathing circuit... 4-14 Connecting the water trap to the breathing circuit... 4-15 Connecting a HME (heat and moisture exchanger)... 4-16 Connecting the humidifier... 4-18 Connecting the nebulizer...4-20 Disposable nebulizer... 4-21 Assembling the nebulizer... 4-21 Filling the nebulizer... 4-22 Disassembling the nebulizer... 4-23 Functional test... 4-24 Airway modules... 4-25 Compatible airway modules... 4-26 Connecting the airway module and module bay...4-28 Connecting the Pedi-lite(+) and D-lite(+) sensors... 4-30 Airway module calibration... 4-31 Connecting the support arm... 4-33 Removing the display unit... 4-35 Installing the display unit on a rail system... 4-36 Installing the display unit on the ventilator... 4-37 Connecting the auxiliary pressure tubing... 4-38 Purging the auxiliary pressure tubing... 4-38

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Table of Contents Zeroing auxiliary pressure... 4-39 Connecting to a compressor... 4-40 Nurse call connection... 4-41 Communication port connection... 4-43 IT network connection... 4-45 Connecting isolated electrical outlets... 4-46

5 Ventilation modes Ventilation mode basics... 5-2 Invasive and non-invasive ventilation... 5-2 Mechanical and spontaneous breaths... 5-2 Ventilation mode settings... 5-3 Positive end expiratory pressure (PEEP)... 5-5 Pressure support... 5-6 Flow and pressure triggering...5-6 Breath timing preferences... 5-7 Ventilation mode features... 5-9 Tube compensation... 5-9 Assist control... 5-9 Leak compensation... 5-10 Trigger compensation... 5-10 Backup mode...5-11 Assist control volume control (A/C VC)...5-12 Assist control pressure control (A/C PC)... 5-14 Assist control pressure regulated volume control (A/C PRVC)... 5-16 Synchronized intermittent mandatory ventilation volume control (SIMV VC)... 5-18 Synchronized intermittent mandatory ventilation pressure control (SIMV PC)... 5-20 Synchronized intermittent mandatory ventilation pressure regulated volume control (SIMV PRVC)... 5-22 Continuous positive airway pressure / pressure support (CPAP/PS)...5-24 BiLevel airway pressure ventilation (BiLevel)... 5-26

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CARESCAPE™ R860 BiLevel airway pressure ventilation volume guaranteed (BiLevel VG)... 5-28 Airway pressure release ventilation (APRV)...5-30 Volume Support (VS)... 5-32 Non-invasive ventilation (NIV)...5-34 Spontaneous breathing trial (SBT mode)... 5-37

6 Operation Power...6-2 Turning on power to the ventilator...6-2 Turning off power to the ventilator...6-2 Patient Setup... 6-4 New Patient... 6-4 Previous Patient... 6-4 Current Patient...6-5 System Check... 6-6 System Check overview... 6-6 Circuit Setup... 6-7 Running a System Check... 6-7 Patient ventilation... 6-10 Setting the ventilator data source... 6-10 System menu...6-10 Setting a ventilation and backup mode... 6-11 Starting patient ventilation... 6-12 Pausing ventilation... 6-13 Setting Favorites... 6-14

7 Procedures Suction... 7-2 Nebulizer treatment... 7-3 Pneumatic nebulizer... 7-5 Performing an Increase O2 procedure... 7-6 Performing an Inspiratory Hold... 7-7

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Table of Contents Performing an Expiratory Hold... 7-8 Manual breath... 7-9 Measuring P 0.1... 7-10 Measuring Negative Inspiratory Force (NIF)...7-11 Measuring Vital capacity... 7-12 Measuring Auto PEEP...7-13 PEEPi Volume... 7-13

8 Alarms and troubleshooting Alarms... 8-2 Alarm management... 8-3 Alarm bar... 8-3 Alarm setup... 8-4 Auto limits... 8-6 Alarm priority... 8-6 Audio pause...8-7 Secondary audio alarm... 8-8 Measured data alarms...8-8 List of alarms - adult and pediatric... 8-9 Alarm filters... 8-25 Alarm delays... 8-26 Alarm tests...8-28 Low O2 alarm test... 8-28 High O2 alarm test...8-28 Low EtO2 alarm test... 8-29 High EtO2 alarm test... 8-30 Low EtCO2 alarm test... 8-30 High EtCO2 alarm test... 8-31 PEEPe low alarm test... 8-31 PEEPe high alarm test... 8-32 VTexp low alarm test... 8-32 VTexp high alarm test... 8-33 Pmax alarm test...8-33

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CARESCAPE™ R860 O2 supply pressure low alarm test... 8-34 Air supply pressure low alarm test... 8-34 Sustained airway pressure (Paw) alarm test... 8-35 Minute volume alarm test... 8-35 Breathing circuit occlusion alarm test... 8-36 Breathing circuit alarm leak test... 8-36 Apnea alarm test... 8-37 Patient disconnected alarm test... 8-37 Nebulizer not connected alarm test... 8-38 Low internal battery alarm test... 8-38 Power failure alarm test...8-39 Internal errors... 8-40 Troubleshooting...8-41 NIV Troubleshooting... 8-43 General messages... 8-44

9 Patient monitoring Patient data and waveforms... 9-2 Measured data definitions... 9-2 Waveform settings...9-5 Spirometry settings... 9-7 Reading waveforms...9-8 Reading spirometry loops... 9-10 Trends workspace... 9-11 Review trends... 9-12 Trends timeline... 9-12 Graphical trends view... 9-13 Numerical trends view... 9-14 Trends log view... 9-15 Snapshot trends view... 9-17

10 Clinical decision support SBT view... 10-2

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Table of Contents Review spontaneous breathing trial data... 10-3 Perform a spontaneous breathing trial... 10-3 Functional residual capacity view... 10-5 FRC procedures... 10-5 FRC INview procedure... 10-6 PEEP INview procedure... 10-7 Lung INview procedure... 10-8 FRC tabs... 10-9 Spirometry view... 10-14 Spirometry tab... 10-14 SpiroDynamics tab... 10-16 Set up and view SpiroDynamics... 10-20 Metabolics view... 10-22 Steady state ventilation... 10-23 Perform a Metabolics measurement... 10-23 Review Metabolics data... 10-24 Calculations view...10-26 Lab data...10-27 Input tab...10-27 Ventilation tab... 10-28 Oxygenation tab... 10-28

11 System configuration (Super User) and service Configuration menu (Super User)... 11-2 Access the Configuration menu... 11-2 Configuring units... 11-2 Configuring time and date... 11-3 Configuring ventilator settings...11-4 Assign mode favorites... 11-4 Calibrations... 11-5 Copy configuration...11-6 Assign facility default settings... 11-7 Assign facility default views...11-8

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CARESCAPE™ R860 Factory default settings... 11-9 Service menus...11-12 Localization... 11-12 Optional features... 11-13 Service log... 11-14

12 Cleaning and maintenance Repair policy... 12-2 Approved service...12-2 Storing the ventilator... 12-2 Disposal... 12-3 System data...12-4 Testing battery performance... 12-4 Maintenance summary and schedule... 12-6 User maintenance... 12-6 Airway module maintenance... 12-7 Compressor maintenance... 12-7 Component replacement schedule... 12-8 Component processing compatibility... 12-9 External surfaces processing compatibility...12-10 Fan filters... 12-11 Compressor filter... 12-13 ISO 17664 compliance... 12-14 Component processing... 12-15 Inspiratory safety guard...12-15 Disassemble for processing... 12-16 Neonatal flow sensor (NFS)... 12-16 Pedi-lite(+) and D-lite(+) sensors... 12-16 Expiratory flow sensor... 12-17 Exhalation valve assembly... 12-18 Water trap (cart mounted)... 12-19 Manual cleaning... 12-21 Soaking... 12-21

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Table of Contents Manual disinfection... 12-23 Hydrogen peroxide... 12-23 Ortho-phthaldehyde...12-24 Automated cleaning...12-25 Sterilization... 12-26 Autoclave... 12-26 Aerogen Pro Nebulizer... 12-27 Component replacement schedule - nebulizer... 12-27 Disassemble for processing - nebulizer... 12-27 Manual cleaning - nebulizer... 12-28 Manual disinfection - nebulizer... 12-28 Automatic cleaning and disinfection... 12-29 Sterilization - nebulizer... 12-30

13 Specifications Overview... 13-2 Physical specifications... 13-3 Alarm sound pressure... 13-4 Environmental specifications...13-5 Pneumatic specifications...13-6 Electrical specifications... 13-7 Battery information... 13-7 Battery status...13-8 Low internal battery alarm test... 13-9 Testing battery performance... 13-10 Equipotential stud... 13-11 Ventilation specifications... 13-12 Ventilation settings... 13-12 Alarm settings... 13-15 Waveform specifications... 13-16 Nebulizer... 13-16 Ventilation delivery specifications... 13-19 Tidal volume delivery...13-20

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CARESCAPE™ R860 Inspired pressure control...13-20 PEEP control... 13-20 Oxygen-air mixture accuracy... 13-21 Ventilator breathing system compliance and resistance... 13-21 Filter specifications... 13-22 Ventilation monitoring specifications...13-22 Airway module... 13-25 Gas specifications for E- series modules... 13-25 Gas specifications for CARESCAPE modules... 13-26 E-series typical performance...13-27 CARESCAPE module typical performance... 13-28 Airway module measurement limitations... 13-29 Electromagnetic compatibility (EMC)... 13-31 Essential performance...13-31 Cables and accessories... 13-32 Guidance and manufacturer’s declaration electromagnetic emissions... 13-32 Guidance and manufacturer’s declaration electromagnetic immunity... 13-33 Recommended separation distances... 13-35 Electrical safety... 13-37 Classification... 13-38

14 Clinical theory Functional residual capacity... 14-2 Nitrogen washout...14-3 Metabolics... 14-4 Leak compensation calculation... 14-5 Airway module... 14-6 Gas exchange... 14-6 Gas exchange measurements... 14-6 Static measurements...14-7 Evaluate airway module data... 14-8

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Table of Contents Oxygen consumption (VO2)... 14-8 Carbon dioxide production (VCO2)...14-9 Respiratory quotient (RQ)... 14-9 Energy expenditure (EE)... 14-10 Airway module test method...14-12 VT setting calculation... 14-13 Body Surface Area (BSA) calculation... 14-14 Ideal Body Weight (IBW) calculation...14-15

15 System theory of operation System operation...15-2 Electrical operation... 15-3 Display Unit... 15-4 Ventilator Control Board... 15-5 Ventilation Monitoring Board... 15-5 Power Management Board... 15-5 Motherboard... 15-5 Monitoring Interface Board... 15-6 Pneumatic operation... 15-7 Inspiratory... 15-8 Expiratory...15-9 Hazard protection... 15-9

16 Parts and accessories Replacement parts and accessories...16-2 System accessories...16-3 System parts... 16-5 Power cords...16-6 Airway module... 16-7 Exhalation valve assembly... 16-8 Exhalation valve heater... 16-9

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17 Neonatal Introduction Overview of neonatal ventilation... 17-2 Neonatal manual... 17-2

18 Neonatal setup and connections General use and safety precautions... 18-2 Connecting the Neonatal Flow Sensor (NFS)...18-4

19 Neonatal ventilation modes Ventilation mode basics... 19-2 Invasive and non-invasive ventilation... 19-2 Mechanical and spontaneous breaths... 19-2 Ventilation mode settings... 19-3 Positive end expiratory pressure (PEEP)... 19-5 Pressure support... 19-6 Flow and pressure triggering...19-6 Breath timing preferences... 19-7 Ventilation mode features... 19-9 Assist control... 19-9 Leak compensation... 19-9 Trigger compensation... 19-10 Backup mode...19-10 Nasal continuous positive airway pressure (nCPAP)... 19-12 Invasive neonatal ventilation modes... 19-14

20 Neonatal Operation Power...20-2 Turning on power to the ventilator... 20-2 Turning off power to the ventilator...20-2 Patient Setup... 20-4 New Patient... 20-4

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Table of Contents Previous Patient... 20-4 Current Patient... 20-5 System Check... 20-6 System Check overview - neonatal...20-6 Running a neonatal system check... 20-7 Patient ventilation... 20-9 Setting the ventilator data source... 20-9 System menu (neonatal)... 20-9 Setting a ventilation and backup mode... 20-10 Starting patient ventilation... 20-11 Standby... 20-12 Ventilation adjustments... 20-13 Setting Favorites... 20-13

21 Neonatal procedures Suction... 21-2 Nebulizer treatment... 21-3 Pneumatic nebulizer... 21-4 Performing an Increase O2 procedure... 21-5

22 Neonatal alarms and troubleshooting Alarms... 22-2 Alarm management... 22-3 Alarm bar... 22-3 Alarm setup... 22-4 Alarm priority... 22-6 Audio pause...22-7 Measured data alarms...22-8 List of alarms... 22-9 Alarm filters... 22-23 Alarm delays... 22-24 Battery status...22-26 Internal errors... 22-27

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CARESCAPE™ R860 Troubleshooting...22-28 nCPAP Troubleshooting... 22-30 General messages... 22-31

23 Neonatal patient monitoring Patient data and waveforms... 23-2 Neonatal measured data definitions... 23-2 Waveform settings...23-5 Access waveform settings...23-5 Waveform field configuration...23-6 Waveform style... 23-6 Waveform speed... 23-6 Waveform color... 23-6 Waveform and spirometry loop scaling...23-6 Spirometry settings... 23-8 Configure spirometry loops - Neonatal... 23-8 Waveform and spirometry loop scaling...23-8 Reading waveforms...23-9 Reading spirometry loops... 23-11 Neonatal Trends... 23-12 Trends workspace - Neonatal... 23-12 Review trends... 23-13 Trends timeline... 23-14 Graphical trends view... 23-14 Neonatal numerical trends view... 23-15 Trends log view... 23-17 Snapshot trends view... 23-18 Measured patient data snapshots...23-20 Waveform snapshots...23-20 Alarms snapshots... 23-20 Review snapshot trends... 23-21

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24 Neonatal clinical decision support SBT view - Neonatal... 24-2 Perform a spontaneous breathing trial... 24-3 Review spontaneous breathing trial data - neonatal . . 24-4 Spirometry view... 24-5 Spirometry... 24-5

25 Neonatal cleaning and maintenance Neonatal flow sensor (NFS)... 25-2 Processing the neonatal flow sensor... 25-3 Calibrating the neonatal flow sensor...25-4

26 Neonatal specifications and settings Overview... 26-2 Neonatal ventilation settings... 26-2 Neonatal alarm settings...26-3 Waveform specifications... 26-4 Neonatal tidal volume delivery... 26-5 Inspired pressure control...26-5 PEEP control... 26-5 Oxygen-air mixture accuracy... 26-6 Ventilation breathing system compliance and resistance - Neonatal... 26-6 Ventilation monitoring specifications - Neonatal... 26-7

27 Neonatal parts and accessories Replacement parts and accessories...27-2 Inspiratory safety guard...27-2 Neonatal flow sensor...27-3

Index

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1 Introduction

Introduction

In this section

Welcome... 1-2 General information... 1-4

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CARESCAPE™ R860

Welcome Thank you for choosing the GE Healthcare CARESCAPE™ R860. Our goal is to provide you with the highest quality product and services available. This ventilator features a user interface specifically designed to streamline workflow while providing exceptional insight into patient needs.

Indications for use/Intended use The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules. Not all features are available for all patient types or product configurations. The CARESCAPE R860 ventilator is not a pulmonary function calculation device. The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

Contraindications None known.

Operational use The ventilator must only be operated by authorized medical personnel well trained in the use of this product. The ventilator must be operated according to the instructions in this User’s Reference Manual.

WARNING

1-2

This ventilator is not intended for use as a facility to facility transport ventilator.

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This ventilator is not indicated for use with anesthetic agents.

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MR unsafe. This ventilator is not suitable for use in a magnetic resonance imaging (MRI) environment.

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