Philips V60 User Manual

Download

Page 1

Respironics V60 V entilator

User Manual

Page 2

For Technical Support and Customer Service, contact:

USA and Canada: 800-345-6443 or 724-387-4000 Respironics Europe, Africa, Middle East: +33-1-47-52-30-00 Respironics Asia Pacific: +852-3194-2280 Facsimile: +1-724-387-5012

USA

Respironics California, Inc. 2271 Cosmos Court Carlsbad, CA 92011

Email and web addresses

service@philips.com clinical@philips.com www.philips.com\healthcare

Authorized European representative

Respironics Deutschland GmbH Gewerbestrasse 17 D-82211 Herrsching Germany +49-8-15-29-30-60

This work is protected under T itle 17 of the United States copyright code and is the sole property of Respironics. No part of this document may be copied or otherwise reproduced, or stored in any electronic information retrieval system, except as specifically permitted under United States copyright law, without the prior written consent of Respironics.

Page 3

Table of contents

1. Warnings, cautions, and notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Preparing for ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Alarms and messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Care and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

First-time installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Communications interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Diagnostic mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

2. Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

3. General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

About CO

Potential side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Physical description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

rebreathing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Patient circuits, masks/patient interfaces, and accessories . . . . . . . 3-4

Ventilator unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Graphical user interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

4. Principles of operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

System operational overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Pneumatic system operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Breath delivery characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Control variable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Triggering, cycling, and leak adaptation . . . . . . . . . . . . . . . . . . . . 4-2

Baseline pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Pressure rise time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Negative pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Oxygen concentration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Auto-Trak Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Triggering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Cycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Leak adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Ventilation modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

CPAP mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

PCV mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

S/T mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

AVAPS mode (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

1047358 Rev A Respironics V60 Ventilator User Manual iii

Page 4

Table of contents

5. Preparing for ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Connecting external devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Connecting oxygen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Installing the patient circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Connecting to AC power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

About the optional backup battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Starting up the ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Shutting down the ventilator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Navigating the graphical user interface . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Preoperational check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Required materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Alarm tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

High Inspiratory Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Low Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Patient Disconnect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Patient Circuit Occluded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

6. Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Changing the mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Changing control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Making batch setting changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Changing individual ventilator settings . . . . . . . . . . . . . . . . . . . . . . 6-4

Using the Ramp Time function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Changing alarm settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Selecting the mask and exhalation port . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Running the exhalation port test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Other functions: the Menu window . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Brightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Loudness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Mask/Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Vent Info (ventilator information) . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Screen Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

Help function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14

Table of modes and control settings . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15

7. Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Display conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Table of monitored parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Scaling the waveform axes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Freezing and unfreezing waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

iv Respironics V60 Ventilator User Manual 1047358 Rev A

Page 5

Table of contents

8. Alarms and messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Responding to alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Setting alarm loudness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

Silencing alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Resetting alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Manually resetting alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Clearing autoreset alarms from the Alarms list . . . . . . . . . . . . . . . . 8-5

Hiding/displaying alarm messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

Alarms and other messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

9. Care and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Ventilator exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Bacteria filter, patient circuit, and other accessories . . . . . . . . . . . 9-2

Preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Replacing the air inlet filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

Cleaning or replacing the cooling fan filter . . . . . . . . . . . . . . . . . . 9-5

Removing and replacing the battery . . . . . . . . . . . . . . . . . . . . . . . 9-6

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Repairs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Repacking and shipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

10. Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

Menu window settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

Operator-accessible diagnostic mode functions. . . . . . . . . . . . . . . . . . 10-4

Physical characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4

Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Pneumatic specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Electrical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Other specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

A. First-time installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Unpacking and inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Mounting the ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Installing the optional battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Installing oxygen inlet connector and AC power cord (Outside the USA and Ja-

pan only). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6

Installing the oxygen manifold kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

Configuration and screen calibration . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

1047358 Rev A Respironics V60 Ventilator User Manual v

Page 6

Table of contents

B. Communications interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

RS-232 serial and analog I/O port. . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

Pinout of connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

Communications protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Commands and transmission conventions . . . . . . . . . . . . . . . . . . . B-3

Remote alarm port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-12

C. Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

One-year warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

Warranty limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

D. Parts and accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

Adult masks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

Pediatric masks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

Exhalation ports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

Patient breathing circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4

Bacteria filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4

Operator maintenance parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4

Other parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5

E. Regulatory compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1

Electromagnetic compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . E-1

Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1

F. Diagnostic mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1

Entering the diagnostic mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1

System settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3

Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-4

Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-6

Pressure Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-7

Restore Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-8

Software Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-9

Baud Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-10

Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-11

Significant Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-11

Touchscreen calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-13

Exiting the diagnostic mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-13

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1

vi Respironics V60 Ventilator User Manual 1047358 Rev A

Page 7

Chapter 1. Warnings, cautions, and notes

Before using the Respironics V60 Ventilator on a patient, familiarize yourself with this user manual, particularly the safety considerations listed. Be aware, however, that this manual is a reference only. It is not intended to supersede your institution’s protocol regarding the safe use of assisted ventilation.

Definitions WARNING: Alerts the user to the possibility of injury, death, or other serious adverse

reactions associated with the use or misuse of the device.

CAUTION: Alerts the user to the possibility of a problem with the device

associated with its use or misuse, such as device malfunction, device failure, damage to the device, or damage to other property.

NOTE: Emphasizes information of particular importance.

General WARNING: An alternative means of ventilation shall be available whenever the

ventilator is in use. If a fault is detected in the ventilator, disconnect the patient from it and immediately start ventilation with such a device. The ventilator must be removed from clinical use and serviced by Respironicsauthorized service personnel.

WARNING: Use the Respironics V60 Ventilator on spontaneously breathing patients

only. It is an assist ventilator and is intended to augment the ventilation of a spontaneously breathing patient. It is not intended to provide the total ventilatory requirements of the patient.

WARNING: We do not recommend you use the Respironics V60 Ventilator on patients

who require ventilation at predetermined tidal volumes. The ventilator provides continuous positive airway pressure (CPAP) and positive pressure ventilation (S/T, PCV, and AVAPS) and is indicated for assisted ventilation only. These modes do not provide ventilation with guaranteed tidal volume delivery.

WARNING: We do not recommend you use AVAPS on patients who require rapid and

frequent IPAP adjustments to maintain a consistent tidal volume. AV APS, a volume targeted mode, changes the IPAP setting in order to achieve the target tidal volume. During AVAPS setup, there may be a period of time before the target tidal volume is achieved. AVAPS is ideal for more stabilized patients.

1047358 Rev A Respironics V60 Ventilator User Manual 1-1

Page 8

Chapter 1

Warnings, cautions, and notes

WARNING: To reduce the risk of CO2 rebreathing, make sure EPAP pressures and

exhalation times are sufficient to clear all exhaled gas through the exhalation port. In noninvasive ventilation continuous air flow through the port flushes exhaled gases from the circuit. The ability to completely exhaust exhaled gas from the circuit depends on the EPAP setting and I:E ratio. Higher tidal volumes further increase the volume of CO

rebreathed

by the patient.

WARNING: To reduce the risk of CO

rebreathing, monitor the patient for changes in

respiratory status at the start of ventilation and with each change in ventilator settings, circuit configuration, or patient condition. Pay attention to ventilator alarms that warn of increased CO

rebreathing risk.

WARNING: Be aware of the possibility of contamination from patient exhalate being

exhausted into the room through the exhalation port.

WARNING: To ensure accuracy of oxygen administration and to monitor for the

presence of contamination (incorrect gas connected), use an external oxygen monitor to verify the oxygen concentration in the delivered gas.

WARNING: To reduce the risk of fire, use the ventilator in well-ventilated areas away

from flammable anesthetics. Do not use in a hyperbaric chamber or other similarly oxygen-enriched environments. Do not use near an open flame.

WARNING: To reduce the risk of electric shock from liquid entering the device, do

not put a container filled with a liquid on the ventilator.

WARNING: To reduce patient risk of hypoxemia, keep free-flowing oxygen away from

air inlet of ventilator.

WARNING: The nurse call/remote alarm should be considered a backup to the

ventilator’s primary alarm system.

WARNING: To ensure that the alarm will be heard, make sure the alarm loudness is

adequate and avoid blocking the alarm speakers beneath the ventilator.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a

physician.

CAUTION: The Respironics V60 Ventilator is designed to operate in the

temperature range of 5 to 40 ºC (41 to 104 ºF). To minimize the risk of overheating the device, do not operate adjacent to heaters or other heat sources.

NOTE: The displays shown in this manual may not exactly match what you

see on your own ventilator.

NOTE: Pressures are indicated on the ventilator in cmH

O. Millibars and

hectopascals (hPa) are used by some institutions instead. Since 1 millibar equals 1 hPa, which equals 1.016 cmH

O, the units may

be used interchangeably.

NOTE: The ventilator is not intended for use as an ambulance transport

ventilator or as an Automatic Transport Ventilator as described by the American Hospital Association and referenced by the FDA. It is intended to allow the patient to be transported within the hospital setting using a cart to move the ventilator.

NOTE: When attachments or other components or subassemblies are added

to the ventilator breathing system, the pressure gradient across the ventilator breathing system, measured with respect to the ventilator outlet, may increase.

1-2 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 9

Chapter 1

Warnings, cautions, and notes

NOTE: To ensure the correct performance of the ventilator and the accuracy

of patient data, we recommend you use only Respironics-approved accessories with the ventilator. See Appendix D, “Parts and accessories”.

NOTE: This Respironics V60 Ventilator and its recommended accessories

that have patient contact are free of latex.

NOTE: If an alarm persists for no apparent reason, discontinue ventilator use

and contact Respironics.

NOTE: If you detect any unexplained changes in the performance or visual

displays of the ventilator, discontinue ventilator use and contact Respironics.

NOTE: The Respironics V60 Ventilator does not support automatic record

keeping.

Preparing for ventilation

WARNING: Connect the ventilator to an appropriate medical-grade oxygen source

only. The source must be able to deliver 100% oxygen regulated to 276 to 600 kPa (40 to 87 psig).

WARNING: To reduce the risk of hypoxia, connect only oxygen to the high-pressure

connector at the rear of the ventilator.

WARNING: To reduce the risk of fire, do not use a high-pressure oxygen hose that is

worn or contaminated with combustible materials like grease or oil.

WARNING: Always check the status of the oxygen cylinders before using the

ventilator during transport.

WARNING: To prevent possible asphyxia and to reduce the risk of CO

take these precautions with respect to mask and exhalation port use:

WARNING: Use only a mask with an exhalation port or a nasal mask for noninvasive

ventilation. WARNING: Do not occlude the exhalation port. WARNING: Turn on the ventilator and verify that the port is operational before

application. Pressurized gas from the ventilator should cause a

continuous flow of air to exhaust from the leak port, flushing exhaled gas

from the circuit. WARNING: Never leave the mask on the patient while the ventilator is not operating.

When the ventilator is not operating, the exhalation port does not allow

sufficient exhaust to eliminate CO

rebreathing may occur. WARNING: To ensure normal air circulation and exchange, do not cover or block the

ports on the ventilator or ventilator circuit. Do not block the air inlet panel

on the right side of the ventilator. WARNING: To prevent possible patient injury and possible water damage to the

ventilator, make sure the humidifier is set to appropriate temperature and

humidification settings.

from the circuit. Substantial CO

rebreathing,

1047358 Rev A Respironics V60 Ventilator User Manual

1-3

Page 10

Chapter 1

Warnings, cautions, and notes

WARNING: To prevent the possibility of inadequate humidification, pay close

attention to the humidifier’s functioning when operating the ventilator at an ambient temperature > 30 ºC (86 ºF). The ventilator warms the air delivered to the patient above ambient temperature, which may impair the humidifier’s performance.

WARNING: To reduce the risk that the patient will aspirate condensed water from the

breathing circuit, position any humidifier lower than both the ventilator and the patient.

WARNING: To prevent possible patient injury and equipment damage, do not turn the

humidifier on until the gas flow has started and is regulated. Starting the heater or leaving it on without gas flow for prolonged periods may result in heat build-up, causing a bolus of hot air to be delivered to the patient. Circuit tubing may melt under these conditions. Turn the heater power switch off before stopping gas flow.

WARNING: To reduce the risk of fire, use only patient circuits intended for use in

oxygen-enriched environments. Do not use antistatic or electrically conductive tubing.

WARNING: To prevent patient or ventilator contamination, we recommend you use a

Respironics-approved main flow bacteria filter on the patient gas outlet port. Filters not approved by Respironics may degrade system performance.

WARNING: To reduce the risk of bacterial contamination or damage, handle bacteria

filters with care.

WARNING: Any additional accessories in the patient circuit may substantially

increase flow resistance and impair ventilation.

WARNING: To reduce the risk of strangulation from patient tubing, use a tubing

support arm and secure the proximal pressure line with clips.

WARNING: To reduce the risk of electric shock, connect the ventilator to an AC

supply mains with protective earth only.

WARNING: Do not use extension cords, adapters, or power cords with the ventilator

that are not approved by Respironics.

WARNING: To prevent unintentional disconnection of the power cord, always use the

correct, Respironics-supplied power cord and lock it into place with the power cord retainer before you switch the ventilator on. The retainer is designed to hold the connector end of the Respironics-supplied cord securely in place.

WARNING: To reduce the risk of electric shock, regularly inspect the AC power cord

and verify that it is not frayed or cracked.

WARNING: To reduce the risk of strangulation, route the power cord to avoid

entanglement.

WARNING: To reduce the risk of power failure, pay close attention to the battery’s

charge level. The battery’s operation time is approximate and is affected by ventilator settings, discharge and recharge cycles, battery age, and ambient temperature. Battery charge is reduced at low ambient temperatures or in situations where the alarm is continuously sounding.

1-4 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 11

Chapter 1

Warnings, cautions, and notes

WARNING: To ensure the ventilator’s safe operation, always run the full

preoperational check described in “Preoperational check” on page 5-8

before using the ventilator on a patient. If the ventilator fails any tests,

remove it from clinical use immediately. Do not use the ventilator until

necessary repairs are completed and all tests have passed. WARNING: To prevent possible patient injury, disconnect the patient from the

ventilator before running the preoperational check. Make sure another

source of ventilatory support is available. WARNING: To prevent possible patient injury due to nonannunciating alarms, verify

the operation of any remote alarm device before use. WARNING: To prevent possible patient injury, always return alarm settings to

hospital-standard values after the preoperational check.

CAUTION: To prevent possible damage to the ventilator, ensure that the

connection to the oxygen supply is clean and unlubricated, and that

there is no water in the oxygen supply gas. CAUTION: For 120 V equipment, grounding reliability can only be achieved

when it is connected to an equivalent receptacle marked “hospital

only” or “hospital grade.”

Operation WARNING: To prevent possible patient injury, avoid setting alarm limits to extreme

values, which can render the alarm system useless.

Alarms and messages WARNING: If AC power fails and the backup battery is not installed or is depleted, an

audible and visual alarm annunciates for at least 2 minutes. Immediately

discontinue ventilator use and secure an alternative means of ventilation.

As in most ventilators with passive exhalation ports, when power is lost,

sufficient air is not provided through the circuit and exhaled air may be

rebreathed.

Care and maintenance

WARNING: To reduce the risk of electric shock, power down the ventilator and

disconnect it from AC power before cleaning or servicing it. WARNING: To prevent patient or ventilator contamination, inspect and replace the

main flow bacteria filter between patients and at regular intervals (or as

stated by the manufacturer). WARNING: To prevent possible patient injury, inspect and verify the proper operation

of the exhalation port regularly during use. WARNING: To reduce the risk of fire, explosion, leakage, or other hazard, take these

precautions with respect to the battery:

1047358 Rev A Respironics V60 Ventilator User Manual

1-5

Page 12

Chapter 1

Warnings, cautions, and notes

- Do not attempt to disassemble, open, drop, crush, bend or deform, insert foreign objects into, puncture, or shred the battery pack; modify or remanufacture it; immerse or expose it to water or other liquids; expose it to fire, excessive heat (including soldering irons); or put it in a microwave oven.

- Replace the battery only with another battery specified by the manufacturer.

- Follow all instructions for proper use of the battery.

- Do not short-circuit the battery or allow metallic or conductive objects to contact the battery connector housing.

- Use the battery with the Respironics V60 Ventilator only.

CAUTION: Do not attempt to sterilize or autoclave the ventilator. CAUTION: To prevent possible damage to the ventilator, use only those cleaning

agents listed in this manual.

CAUTION: To prevent possible damage to the touchscreen, take care when

cleaning it. Do not drip water and/or soap solution. After cleaning and rinsing, remove all moisture with a dry, soft cloth. Never clean the touchscreen with an abrasive brush or device, since this will cause irreparable damage.

CAUTION: To avoid introducing foreign matter into the ventilator and to ensure

proper system performance, change the air inlet filter at regular intervals (or as stipulated by your institution).

CAUTION: T o ensure proper system performance, use a Respironics-approved air

inlet filter.

CAUTION: Because some environments cause a quicker collection of lint and

dust than others, inspect the filters more often when needed. The air inlet filter should be replaced; the cooling fan filter should be cleaned.

CAUTION: To prevent possible damage to the ventilator, always ship it with the

original packing material. If the original material is not available, contact Respironics to order replacements.

First-time installation WARNING: Never attempt to disconnect or connect the battery during operation.

CAUTION: To prevent possible damage to the ventilator, always secure it to its

stand or securely place it on a flat, stable surface that is free of dirt and debris. Do not use the ventilator adjacent to, or stack it with, other equipment.

1-6 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 13

Chapter 1

Warnings, cautions, and notes

Communications interface

WARNING: Connect to the ventilator only items that are specified as part of or

compatible with the ventilator system. Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards. Furthermore, all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of edition 3 of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible for ensuring that the system complies with the requirements for medical electrical systems. Also be aware that local laws may take priority over the above mentioned requirements. If in doubt, consult Respironics.

WARNING: It is the responsibility of the end user to validate the compatibility and use

of information transmitted from the ventilator to the device to be connected to the ventilator.

WARNING: The data provided through the communications interface is for reference

only. Decisions for patient care should be based on the clinician’s observations of the patient.

WARNING: To prevent possible patient injury due to nonannunciating alarms, verify

the operation of any remote alarm device before use.

WARNING: To ensure the functionality of the remote alarm, connect only Respironics-

approved cables to the remote alarm port.

CAUTION: The remote alarm port is intended to connect only to an SELV (safety

extra-low voltage and ungrounded system with basic insulation to ground), in accordance with IEC 60601-1. To prevent damage to the remote alarm, make sure the signal input does not exceed the maximum rating of 24 VAC or 36 VDC at 500 mA with a minimum current of 1 mA.

Diagnostic mode WARNING: To prevent possible patient injury , do not enter the diagnostic mode while

a patient is connected to the ventilator. Verify that the patient is disconnected before proceeding.

1047358 Rev A Respironics V60 Ventilator User Manual

1-7

Page 14

Chapter 1

Warnings, cautions, and notes

(This page is intentionally blank.)

1-8 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 15

Chapter 2. Symbols

Refer to these tables to interpret symbols used on the ventilator labels and packaging and on the ventilator screen. To interpret symbols pertaining to accessories, refer to their instructions for use.

Table 2-1: Symbols used on ventilator labels and packaging

Symbol Description

Warning: Risk of explosion. Do not use in the presence of flammable anesthetics.

Attention, consult the accompanying documents.

Read the user manual before using the ventilator.

Protective earth (ground)

T ype B applied part, wh ich is equi pment that provid es a particular deg ree of protection against electric shock, particularly in regard to allowable leakage current and of the protective earth connection

Requires alternating current (AC)

Degree of fluid ingress protection provided by the enclosure (drip-proof)

Alarm and remote alarm

Two states of control: ON and Shutdown

Battery

European Conformity

Date of manufacture

Manufacturer

1047358 Rev A Respironics V60 Ventilator User Manual 2-9

Page 16

Chapter 2

(On power cord)

Symbols

Table 2-1: Symbols used on ventilator labels and packaging (continued)

Symbol Description

RS-232 RS-232 serial input/output

USB port

Oxygen

Ethernet connection

Accept button on the navigation ring

Adjustment direction on the navigation ring

Canadian Standards Association approval

Do not disassemble. Refer to Respironics-authorized service personnel.

Product must be disposed of in accordance with the WEEE directive.

Noninvasive ventilation (patient with mask)

Invasive ventilation (intubated patient)

Do not block the cooling fan Inlet (at the rear of the ventilator).

Hospital-grade

2-10 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 17

Table 2-1: Symbols used on ventilator labels and packaging (continued)

50C

20C

Symbol Description

This side up

Recycle

Fragile

Keep dry

Do not stack > 3 high

Chapter 2

Symbols

Do not stack > 7 high

Limit temperature to between -20 and 50 ºC (-4 and 122 ºF)

Hazmat class 9

Fire hazard

uR UL recognition symbol

Battery option

1047358 Rev A Respironics V60 Ventilator User Manual 2-11

Page 18

Chapter 2

Symbols

Table 2-2: Symbols used on graphical user interface

Symbol Description

Alarm (audible)

Alarm is silenced

Alarm

Alarm reset

Informational message

Alarm message is displayed. Touch to hide alarm messages.

Alarm message is hidden. Touch to display alarm messages.

Increase and decrease (adjustment arrow) buttons. Adjusts a setting or selects a value.

Accept button. Accepts set values.

Cancel button. Cancels set values.

Ventilator is powered by AC power and the optional battery is installed.

Ventilator is powered by AC power and the optional battery is not installed.

Ventilator is powered by the battery. This symbol shows the approximate battery time remaining in hours and minutes, and it shows the capacity graphically.

Help button. Touch to display onscreen help information.

2-12 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 19

Table 2-2: Symbols used on graphical user interface (continued)

Symbol Description

Vertical autoscale button. Autoscales the Y axis of the graphs to fit the data currently displayed.

Pause button. Freezes waveforms in the Waveform window.

Pause in progress

Resume button. Resumes all waveform graphs from a paused state.

Chapter 2

Symbols

I/TTOT

Time base adjust button. Rescales the X axis of the graph display data at 3, 6, 12, and 24 second increments.

Estimated minute ventilation Estimated exhaled tidal volume

Duty cycle. Inspiratory time divided by total cycle time. No valid data to display

Data is under range

Data is over range

Pressure, centimeters of water

Flow, liters per minute. BTPS compensated.

Volume, milliliters

User-set Ramp Time. Ramp graphic fills in as Ramp Time progresses.

1047358 Rev A Respironics V60 Ventilator User Manual 2-13

Page 20

Chapter 2

Symbols

Table 2-2: Symbols used on graphical user interface (continued)

Symbol Description

Ramp Time is OFF (no ramp time set).

Intentional leak. The number corresponds to the leak symbol printed on Respironics masks.

2-14 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 21

Chapter 3. General information

Intended use The Respironics V60 Ventilator is an assist ventilator and is intended to

augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

The ventilator is intended to support pediatric patients weighing 20 kg (44 lb) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The vent ilator is intended to be used by qualified medical professional s, such as physicians, nurses, and respiratory therapists. The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

About CO2 rebreathing

As with mask ventilation in general, patient CO2 rebreathing may occur under some circumstances. Follow these guidelines to minimize the potential for CO rebreathing. If rebreathing is a significant concern for a particular patien t a nd these guidelines are not sufficient to acceptably reduce the potential for CO rebreathing, consider an alternative means of ventilation.

• Increase EPAP to decrease the potential for CO pressures produce more flow through the exhalation port, which helps to purge all CO

• Be aware that the potential for CO inspiratory time increases. A longer inspiratory time decreases exhalation time, allowing less CO the next cycle. In such circumstances, higher tidal volumes further increase the volume of CO

from the circuit to prevent rebreathing.

rebreathing increases as

to be purged from the circuit before

rebreathed by the patient.

rebreathing. Higher

Potential side effects Advise the patient to immediately report any unusual chest discomfort,

shortness of breath, or severe headache. Other potential side effects of noninvasive positive pressure ventilation include: ear discomfort, conjunctivitis, skin abrasions due to mask/patient interface, and gastric distention (aerophagia). If skin irritation or breakdown develops from the use of the mask, refer to the accompanying mask instructions for appropriate action.

1047358 Rev A Respironics V60 Ventilator User Manual 3-1

Page 22

Chapter 3

General information

Contraindications The Respironics V60 Ventilator is contraindicated for patients with any of the

following conditions:

• Lack of spontaneous respiratory drive

• Inability to maintain a patent airway or adequately clear secretions

• At risk for aspiration of gastric contents

• Acute sinusitis or otitis media

• Hypotension

• Untreated pertussis

• Epistaxis (nosebleed)

General description The Respironics V60 Ventilator (Figure 3-1) is a microprocessor-controlled,

bilevel positive airway pressure (BiPAP) ventilatory assist system that provides noninvasive positive pressure ventilation (NPPV) and invasive ventilatory support for spontaneously breathing adult and pediatric patie nts.

Figure 3-1: Respironics V60 Ventilator

Ventilation modes. The ventilator offers a range of conventional pressure modes, CPAP (continuous positive airway pressure), PCV (pressure-controlled ventilation), and S/T (spontaneous/timed). The volume-targeted AVAPS (average volume-assured pressure support) mode combines the attributes of pressure-controlled and volume-targeted ventilation.

Auto-Trak Sensitivity allows the ventilator to automatically compensate for unintentional leaks by maintaining a stable baseline and adjusting trigger and cycle thresholds for optimum patient-to-ventilator synchrony.

User interface. The ventilator’s ergonomic design, including a 12.1-inch (31cm) color touchscreen, a navigation ring, and key panel, lets you easily access ventilator settings and monitored parameters.

3-2 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 23

Chapter 3

General information

Monitoring. The ventilator displays monitored parameters as numbers and as

real-time waveforms (curves or scalars). Alarms. The ventilator’s operator-adjustable and nonadjustable alarms help

ensure the patient’s safety. Power and gas supplies. The ventilator uses as its primary power source AC

mains. An optional internal backup battery powers the ventilator typically for 6 hours.

The ventilator uses high-pressure oxygen. An integral blower pressurizes gas for delivery to the patient.

Mounting. The ventilator can be mounted to the universal stand. When equipped with the optional cylinder holder, the stand can accommodate two Esize oxygen cylinders.

Communications interface. The ventilator can output data through the RS-232 serial port upon receiving a command from a host computer or bedside monitoring system. The ventilator is equipped with a remote alarm/nurse call connection to activate alarms remotely.

Upgradability via Respironics Respi-Link

remote diagnostic system. The Respi-

Link interface permits software upgrade and remote troubleshooting of the ventilator through the RS-232 port.

1047358 Rev A Respironics V60 Ventilator User Manual 3-3

Page 24

Chapter 3

Oxygen

monitor

Humidifier

Oxygen

cylinder

Patient circuit

Mask

Bacteria filter

Exhalation port

General information

Physical description Patient circuits, masks/patient interfaces, and accessories

Figure 3-2 shows the Respironics V60 Ventilator with its patient circuit and accessories. T a ble 3-1 on page 3-5 lists recommended patient circuits, masks/ patient interfaces, and other accessories for use with the ventilator. Appendix D provides ordering information for Respironics parts and accessories.

Figure 3-2: Respironics V60 Ventilator with accessories

3-4 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 25

Chapter 3

General information

Table 3-1: Recommended parts and accessories

Part Use...

Patient circuit Single-limb patient circuit intended for

noninvasive or invasive ventilation. To minimize turbulence, we recommend that you use smooth-bore tubing. Use a Respironics circuit listed in Appendix D or the equivalent.

Patient interface (noninvasive or invasive) • Respironics masks listed in Appendix D

• Invasive interface (tracheostomy or ET tube)

Exhalation port Respironics exhalation port listed in Ap pen-

dix D or the equivalent

Inspiratory filter Respironics main flow (inspiratory) bacteria

filter listed in Appendix D or the equivalent

Humidifier • Fisher & Paykel

• Hudson RCI CONCHATHERM or CONCHATHERM Neptune

Oxygen monitor • CRITERION

(PN 8-100661-00)

• Teledyne MX300 oxygen monitor

• An equivalent that complies with ISO 7767

MR810 or MR850

OxiCheck oxygen analyzer

1047358 Rev A Respironics V60 Ventilator User Manual 3-5

Page 26

Chapter 3

Key panel

789

General information

Ventilator unit

Figure 3-3 through Figure 3-5 show the controls, indicators, and other important parts of the ventilator unit .

Figure 3-3: Front view

Number Description

1 Graphical user interface. Color LCD (liquid crystal display) with touchscreen. 2 Navigation ring. Lets you adjust values and navigate the graphical user interface

by rotating the finger on its touchpad. 3 Accept button. Activates selections. 4 Proximal pressure port. Connection for tubing that monitors patient pressure in

5 Ventilator outlet (To patient) port. Main connection for the patient circuit. Deliv-

6 Alarm speakers (beneath ventilator) 7 Alarm LED. Flashes during a high-priority alarm. On continuously during a venti-

8 Battery (charged) LED. Flashes when battery is charging. On continuously when

9 ON/Shutdown key with LED. T urns on AC power and initi ates ventilator shutdown.

the patient circuit.

ers air and oxygen in prescribed pressures to the patient.

lator inoperative condition.

battery is charged. Off when ventilator is running on battery or when the venti-

lator is off and AC power is not connected.

LED is continuously on when AC power is connected.

3-6 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 27

Figure 3-4: Side view

1 2

Chapter 3

General information

Number Description

1 Ventilation vents. Allow intake of air for delivery to the patient. 2 Air inlet filter (under side panel). Filters the air for delivery to the patient.

1047358 Rev A Respironics V60 Ventilator User Manual 3-7

Page 28

Chapter 3

7 3 6 54 3 2

General information

Figure 3-5: Rear view

Number Description

1 Backup battery (compartment under side panel). Optional, 6-hour backup bat-

tery. 2 Remote alarm/nurse call connector 3 Reserved for future use 4 Power cord retainer 5 Power cord 6 RS-232 serial and analog I/O connector (female DB-25). Connects to hospital

information systems and other serial devices, and functions as an interface

for analog signals. Connects Respi-Link

for software updates. 7 Cooling fan filter 8 High-pressure oxygen inlet connector

remote diagnostic system gateway

3-8 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 29

Chapter 3

Window/window tabs

(see page 6-1)

Help button (see page 6-14)

Waveforms window

(see page 7-1)

Patient data window

(see page 7-1)

Power symbols

(see page 5-5)

Alarm status bar

(see page 8-2)

Compressed waveforms window with Alarms/ Messages list (see page 8-2)

General information

Graphical user interface

Through the graphical user interface (Figure 3-6) you make ventilator settings and view ventilator and patient data. During ventilation, the upper screen displays alarms and patient data. The middle screen displays real-time waveforms and alarm and informational messa ges. The lower screen lets you access modes and other ventilator settings, display help information, and see

the power status.

1047358 Rev A Respironics V60 Ventilator User Manual 3-9

Figure 3-6: Parts of graphical user interface

Page 30

Chapter 3

General information

(This page is intentionally blank.)

3-10 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 31

Chapter 4. Principles of operation

System operational overview

The Respironics V60 Ventilator is a microprocessor-controlled pneumatic system that delivers a mixture of air and oxygen. It is powered by AC with optional battery backup to protect against power failure or unstable power and to facilitate intrahospital transport. The ventilator’s pneumatics deliver gas and its electrical systems control pneumatics, monitor the patient, and distribute power.

The user provides inputs to the ventilator through a touchscreen, keys, and a navigation ring. These inputs become instructions for the pneumatics to deliver a precisely controlled gas mixture to the patient. Pressure and flow sensors provide feedback, which is used to adjust gas delivery to the patient. Monitored data based on sensor inputs is also displayed by the graphical user interface.

The ventilator’s gas delivery and monitoring functions are cross-checked. This cross-checking helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of system failure.

A comprehensive system of visual and audible alarms helps ensure the patient’s safety. Clinical alarms can indicate an abnormal physiological condition. Technical alarms, triggered by the ventilator’s self-tests, can indicate a hardware or software failure. In the case of some technical alarms, limited ventilation is provided to give the user time for corrective actions. When a condition is critical enough to possibly compromise safe ventilation, the ventilator is placed into the ventilator inoperative state, in which oxygen flow and blower operation are disabled.

The ventilator has several means to ensure that safe patient or respiratory pressures are maintained. The maximum working pressure is ensured by the high inspiratory pressure (HIP) alarm limit. If the set high pressure limit is reached, the ventilator cycles into exhalation.

1047358 Rev A Respironics V60 Ventilator User Manual 4-1

Page 32

Chapter 4

Respironics V60 Ventilator

Blower

High-

pressure

oxygen

Ambient

air

Proximal (patient)

pressure

Ventilator outlet

(machine)

pressure

Air flow

sensor

Mixer

Proportioning

O2 flow

sensor

Air inlet

filter

Main flow

filter

Patient

Exhalation

port

O2 pressure

Principles of operation

Pneumatic system operation

The ventilator uses ambient air and high-pressure oxygen (Figure 4-1). Air enters through an inlet filter. Oxygen enters though a high-pressure inlet, and a proportioning valve provides the operator-set concentration. The system mixes the air and oxygen, pressurizes it in the blower, and then regulates it to the user-set pressure. To do this, the ventilator compares the proximal (patient) pressure measurement with the vent ilator outlet (machine) pressure, and adjusts the machine pressure to compensate for the pressure drop across the inspiratory filter, patient circuit, and humidifier. This helps ensure accurate and responsive pressure delivery and leak compensation.

Figure 4-1: Respironics V60 Ventilator gas delivery system

The ventilator delivers gas to the patient through a main flow (inspiratory) bacteria filter, a single-limb patient breathing circuit, a humidification device (optional) and a patient interface such as a mask or ET tube. A pressure tap proximal to the patient is used to monitor patient pressure. The exhalation port continually exhausts gas from the circuit during inspiration and exhalation to minimize rebreathing and ensure CO

removal.

Breath delivery characteristics

Control variable

Breaths delivered by the Respironics V60 Ventilator are pressure controlled. In the AVAPS mode, the ventilator’s applied pressure is automatically adjusted over several breaths to maintain a target tidal volume.

Triggering, cycling, and leak adaptation

Unlike other ventilators, the Respironics V60 Ventilator does not require you to set triggering and cycling sensitivity or to adjust baseline flow.The ventilator’s unique Auto-Trak Sensitivity algorithm adjusts these automatically; see “AutoTrak Sensitivity” on page 4-3.

Baseline pressure

4-2 Respironics V60 Ventilator User Manual 1047358 Rev A

A positive baseline pressure (EPAP or CP AP) may be set for all breaths in all modes.

Page 33

Chapter 4

Principles of operation

Pressure rise time

The operator-set Rise Time defines the time required for inspiratory pressure to rise to the set (target) pressure.

Negative pressures

There are no negative pressures generated during exhalation.

Oxygen concentration

The Respironics V60 Ventilator incorporates an oxygen mixer. Oxygen concentration can be set in all modes.

Auto-Trak Sensitivity An important characteristic of the Respironics V60 Ventilator is its ability to

recognize and compensate for unintentional leaks in the system and to automatically adjust its triggering and cycling algorithms to maintain optimum performance in the presence of leaks. This is called Auto-Trak Sensitivity. The following subsections describe this func tion in detail.

Triggering

Breaths are patient (flow) triggered in all modes, typically when patient effort causes a certain volume of gas to accumulate above method). An inspiration is also triggered when the patient inspiratory the expiratory flow waveform sufficiently (shape signal method; see page 4-4).

baseline flow (volume

effort distorts

Cycling

Cycling to exhalation occurs in these cases:

• Patient expiratory sufficiently (shape signal method). See “Shape signal method of cycling and triggering.” on page 4-4.

• Patient flow reaches the spontaneous exhalation threshold (SET). See “SET method of cycling.” on page 4-4.

• After 3 seconds at the IPAP level (timed backup safety mechanism)

• When a flow reversal occurs, typically due to a mask or mouth leak

effort distorts the inspiratory flow waveform

1047358 Rev A Respironics V60 Ventilator User Manual 4-3

Page 34

Chapter 4

Estimated

patient flow

Shape

signal

Cycle to exhalation crossover point

Trigger to inspiration crossover point

Spontaneous exhalation threshold

Principles of operation

Shape signal method of cycling and triggering. The shape signal or “shadow

trigger” method uses a mathematical model derived from the flow signal. A new flow signal (shape signal) is generated by offsetting the signal from the actual flow and delaying it (Figure 4-2). This intentional delay causes the flow shape signal to be slightly behind the patient’s flow signal. If there is a sudden change in patient flow, the patient’s flow signal crosses the shape signal; this results in a trigger or a cycle. As a resul t, a su dden d ecr ease in exp ira tory f low from an inspiratory effort will cross the shape signal and create a signal for ventilator triggering.

Figure 4-2: Shape signal

SET method of cycling. Patient flow reaches the spontaneous exhalation threshold (SET); see Figure 4-3. The SET represents the intersection of the flow waveform and a line of a given slope. SET is updated each breath.

Figure 4-3: Spontaneous exhalation threshold (SET)

4-4 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 35

Chapter 4

Flow

TIME

Original baseline

Inspiration

Spontaneous trigger

Cycle to exhalation

End exhalation

Adjustment of baseline

New

baseline

Patient

flow

Additional leak

Principles of operation

Leak adaptation

Noninvasive ventilation in particular may involve considerable leakage around the mask or through the mouth. Some leakage is known or intentional: it is a characteristic of the mask/patient interface design. So that it can accurately adjust its baseline flow, the ventilator has you enter the intentional leakage value specific to the mask/patient interface (“Selecting the mask and exhalation port” on page 6-7). Other leakage is unpredictable or unintentional, and it changes as the patient’s breathing pattern changes.

To maintain prescribed pressures in the presence of leakage, the ventilator adjusts its baseline flow. Because the unintentional part of the leakage may constantly change, the ventilator recalculates the baseline flow each breath at the end of exhalation. The ventilator uses two main mechanisms to update its baseline flow: expiratory flow adjustment and tidal volume adjustment.

Expiratory flow adjustment. Every breath, at end-exhalation, the ventilator updates its flow baseline. At end-exhalation patient flow is assumed to be zero, so any difference between actual patient flow and the original baseline flow indicates a change in leakage. Figure 4-4 shows how the ventilator adjusts the baseline.

1047358 Rev A Respironics V60 Ventilator User Manual 4-5

Figure 4-4: Expiratory flow adjustment

Page 36

Chapter 4

Additional leak introduced

New baseline

Volume adjustment

Flow

Volume

Principles of operation

Tidal volume adjustment. Every breath, the ventilator compares the inspiratory

and expiratory tidal volumes. Any difference is assumed to be due to an unintentional circuit leak. The ventilator adj usts the ba seline to reduce this tidal volume difference for the next breath . Figure 4-5 shows how the ventilator adjusts the baseline.

Figure 4-5: Tidal volume adjustment

4-6 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 37

Chapter 4

Principles of operation

Ventilation modes The Respironics V60 Ventilator operates in the following ventilation modes:

• CPAP (continuous positive airway pressure) mode

• S/T (spontaneous/timed) mode

• PCV (pressure-controlled ventilation) mode

• AVAPS (average volume-assured pressure support) mode (optional)

Table 4-1 summarizes the characteristics of these modes. Note that on the ventilator, the Timed breath indicator means the breath is ventilator triggered, while the Spont breath indicator means the breath is patient triggered.

Table 4-1: Characteristics of Respironics V60 ventilation modes

Mandatory breaths Spontaneous breaths

Mode

CPAP N/A N/A N/A Auto-Trak Pressure Auto-Trak PCV Time,

S/T Time,

AVAPS Time,

* A trigger variable starts inspiration. † A limit variable can reach and maintain a preset level before inspiration ends but it does not

end inspiration.

‡ A cycle variable is a measured parameter used to end inspiration.

Trigger

Auto-Trak

†

Limit

Pressure Time N/A N/A N/A

Pressure Time Auto-Trak Pressure Auto-Trak

Pressure Time,

‡

Cycle

Auto-Trak

Trigger Limit Cycle

Auto-Trak Pressure Auto-Trak

1047358 Rev A Respironics V60 Ventilator User Manual 4-7

Page 38

Chapter 4

Volume Flow

Pressure

CPAP

I E

Time

Principles of operation

CPAP mode

In the CPAP (continuous positive airway pressure) mode, the ventilator functions as a demand flow system, with the patient triggering all breaths and determining their timing, pressure, and size. You set no triggering or cycling sensitivities: the patient triggers and cycles based on the ventilator’s Auto-Trak Sensitivity algorithms. The control settings active in the CPAP mode are shown in Figure 4-6. Figure 4-7 shows CPAP mode waveforms.

The optional C-Flex setting enhances traditional CPAP by reducing the pressure at the beginning of exhalation – a time when patients may be uncomfortable with CPAP – and returning it to the set CPAP level before the end of exhalation.

Figure 4-6: CPAP controls

Figure 4-7: CPAP waveforms

4-8 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 39

Chapter 4

Pressure

EPAP

IPAP

I-TIme

1/Rate

Machine-triggered (Timed) breath

Rise

Time

Patient-triggered (Spont) breath

Principles of operation

PCV mode

The PCV (pressure-controlled ventilation) mode delivers pressure-controlled mandatory breaths, either triggered by the ventilator (Timed) or the patient (Spont). You set no triggering sensitivity: the patient trigger is based on the ventilator’s Auto-Trak Sensitivity algorithms. The control settings active in the PCV mode are shown in Figure 4-8. The IPAP setting defines the applied pressure for all breaths. Rate and I-Time define the breath timing for all breaths. You set no triggering or cycling thresholds: the ventilator’s Auto-Trak Sensitivity algorithms automatically determine when to trigger and cycle based on patient efforts. Figure 4-9 shows a PCV mode pressure waveform.

Figure 4-8: PCV controls

Figure 4-9: PCV pressure waveform

1047358 Rev A Respironics V60 Ventilator User Manual 4-9

Page 40

Chapter 4

Pressure

EPAP

IPAP

I-TIme

1/Rate

Patient-triggered (Spont)

spontaneous breath with

pressure support

Mandatory (Timed) breath

Time

Rise

Principles of operation

S/T mode

The S/T (spontaneous/timed) mode guarantees breath delivery at the user-set rate. It delivers pressure-controlled, time-cycled mandatory and pressuresupported spontaneous breaths, all at the IPAP pressure level. If the patient fails to trigger a breath within the interval determined by the Rate setting, the ventilator triggers a mandatory breath with the set I-Time. You set no patient triggering or cycling sensitivities: the patien t triggers and cycles based on the ventilator’s Auto-Trak Sensitivity algorithms. The control settings active in the S/T mode are shown in Figure 4-10. Figure 4-11 shows an S/T mode pressure waveform.

Figure 4-10: S/T controls

Figure 4-11: S/T pressure waveform

4-10 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 41

Chapter 4

Principles of operation

AVAPS mode (optional)

NOTE: When you adjust AVAPS minimum and maximum pressures,

remember that IPAP is adjusted to meet the target value. If the calculated target pressure is outside of the minimum and maximum pressure range, the target volume will not be achieved.

Unlike most pressure modes, the AVAPS (average volume-assured pressure support) mode delivers a target tidal volume. It achieves the target volume by regulating the pressure applied followin g an initial pressure ramp-up. The AVAPS mode delivers time-cycled mandatory breaths and pressure-supported spontaneous breaths.

If the patient fails to trigger a breath within the interval determined by the Rate control, the ventilator triggers a mandatory breath with the set I-Time. Mandatory and spontaneous breaths are delivered at a pressure that is continually adjusted over a period of time to achieve the volume target, V Min P and Max P define the minimum and maximum pressures that can be applied. You set no patient triggering or cycling sensitivities: the patient triggers and cycles based on the ventilator’s Auto-Trak Sensitivity algorithms.

The control settings active in the AVAPS mode are shown in Figure 4-12. Figure 4-13 shows AVAPS mode waveforms.

Figure 4-12: AVAPS controls

1047358 Rev A Respironics V60 Ventilator User Manual 4-11

Page 42

Chapter 4

Volume Flow

Pressure

Max P

Min P

EPAP

1/Rate

I-TIme

Mandatory (Timed)

breath

Patient-triggered (Spont) spontaneous breath

Rise

Time

Principles of operation

Figure 4-13: AVAPS waveforms

4-12 Respironics V60 Ventilator User Manual 1047358 Rev A

Page 43

Chapter 5. Preparing for ventilation

Set up the ventilator for each patient use as described in this chapter. For firsttime installation, refer to Appendix A.

Connecting external devices

You can connect the ventilator to a remote alarm (nurse call) device and a patient monitor or other external device. See Appendix B for details.

Connecting oxygen WARNING: Connect the ventilator to an appropriate medical-grade oxygen source

only. The source must be able to deliver 100% oxygen regulated to 276 to 600 kPa (40 to 87 psig).

WARNING: To ensure accuracy of oxygen administration and to monitor for the

presence of contamination (incorrect gas connected), use an external oxygen monitor to verify the oxygen concentration in the delivered gas.

WARNING: To reduce the risk of fire, do not use a high-pressure oxygen hose that is

worn or contaminated with combustible materials like grease or oil.

WARNING: To reduce the risk of hypoxia, connect only oxygen to the high-pressure

connector at the rear of the ventilator.

WARNING: Always check the status of the oxygen cylinders before using the

ventilator during transport.

CAUTION: To prevent possible damage to the ventilator, ensure that the

connection to the oxygen supply is clean and unlubricated, and that there is no water in the oxygen supply gas.

NOTE: To avoid depleting the cylinders, close the cylinder valves when using

the wall oxygen supply.

Connect the oxygen hose to the ventilator’s oxygen inlet connector (Figure 5-1) or to the oxygen manifold, if applicable.

1047358 Rev A Respironics V60 Ventilator User Manual 5-1

Page 44

Chapter 5

Oxygen inlet

connector

Preparing for ventilation

Figure 5-1: Oxygen inlet connector

Installing the patient circuit

WARNING: To reduce the risk of strangulation from patient tubing, use a tubing

support arm and secure the proximal pressure line with clips.

WARNING: To prevent possible patient injury and possible water damage to the

ventilator, make sure the humidifier is set to appropriate temperature and humidification settings.