respironics_v60_ventilator_user_manual_rev_a.pdf
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Respironics V60 Ventilator
User Manual
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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
© 2009 Respironics and its affiliates.
All rights reserved.
This work is protected under Title 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preparing for ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarms and messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Care and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
First-time installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Communications interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diagnostic mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1-1
1-1
1-3
1-5
1-5
1-5
1-6
1-7
1-7
2.
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
3.
General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
About CO2 rebreathing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Potential side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Physical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient circuits, masks/patient interfaces, and accessories . .
Ventilator unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Graphical user interface . . . . . . . . . . . . . . . . . . . . . . . . . .
4.
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3-1
3-1
3-1
3-2
3-2
3-4
3-4
3-6
3-9
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
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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 . . . . . . . . . . . .
Table of monitored parameters . . . .
Scaling the waveform axes . . . . . . .
Freezing and unfreezing waveforms .
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7-1
7-2
7-2
7-3
1047358 Rev A
Page 5
Table of contents
8.
Alarms and messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Responding to alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting alarm loudness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Silencing alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Resetting alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manually resetting alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clearing autoreset alarms from the Alarms list . . . . . . . . . . . . . . . .
Hiding/displaying alarm messages . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarms and other messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9.
Care and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilator exterior . . . . . . . . . . . . . . . . . . . . . . . . .
Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bacteria filter, patient circuit, and other accessories
Preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . .
Replacing the air inlet filter . . . . . . . . . . . . . . . . . .
Cleaning or replacing the cooling fan filter . . . . . . .
Removing and replacing the battery . . . . . . . . . . . .
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repacking and shipping . . . . . . . . . . . . . . . . . . . . . . . .
10.
8-1
8-4
8-5
8-5
8-5
8-5
8-6
8-6
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9-1
9-1
9-2
9-2
9-3
9-4
9-5
9-6
9-6
9-6
9-6
9-6
Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Menu window settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operator-accessible diagnostic mode functions . . . . . . . . . . . .
Physical characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . .
Pneumatic specifications . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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10-1
10-2
10-3
10-3
10-4
10-4
10-5
10-5
10-5
10-6
Appendixes
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 Japan only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Installing the oxygen manifold kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Configuration and screen calibration . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
1047358 Rev A
Respironics V60 Ventilator User Manual
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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pediatric masks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exhalation ports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient breathing circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bacteria filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operator maintenance parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
E.
D-1
D-3
D-3
D-4
D-4
D-4
D-5
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
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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
General
1047358 Rev A
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.
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. AVAPS, 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.
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Chapter 1
Warnings, cautions, and notes
1-2
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 CO2 rebreathed
by the patient.
WARNING:
To reduce the risk of CO2 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 CO2 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 cmH2O. Millibars and
hectopascals (hPa) are used by some institutions instead. Since
1 millibar equals 1 hPa, which equals 1.016 cmH2O, 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.
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Chapter 1
Warnings, cautions, and notes
Preparing for
ventilation
1047358 Rev A
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.
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 CO2 rebreathing,
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 CO2 from the circuit. Substantial CO2
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.
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Warnings, cautions, and notes
1-4
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.
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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:
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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.
First-time installation
1-6
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:
To 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.
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.
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Chapter 1
Warnings, cautions, and notes
Communications
interface
Diagnostic mode
1047358 Rev A
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 Respironicsapproved 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.
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.
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Chapter 1
Warnings, cautions, and notes
(This page is intentionally blank.)
1-8
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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)
Type B applied part, which is equipment that provides a particular degree
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
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Chapter 2
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
(On power cord)
2-10
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Chapter 2
Symbols
Table 2-1: Symbols used on ventilator labels and packaging (continued)
Symbol
Description
This side up
Recycle
Fragile
Keep dry
Do not stack > 3 high
3
Do not stack > 7 high
50C
Limit temperature to between -20 and 50 ºC (-4 and 122 ºF)
-20C
Hazmat class 9
Fire hazard
uR UL recognition symbol
Battery option
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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.
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Chapter 2
Symbols
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.
Time base adjust button. Rescales the X axis of the graph display data at
3, 6, 12, and 24 second increments.
VE
Estimated minute ventilation
VT
Estimated exhaled tidal volume
TI/TTOT
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.
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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.
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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 ventilator is
intended to be used by qualified medical professionals, 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
Potential side effects
1047358 Rev A
As with mask ventilation in general, patient CO2 rebreathing may occur under
some circumstances. Follow these guidelines to minimize the potential for CO2
rebreathing. If rebreathing is a significant concern for a particular patient and
these guidelines are not sufficient to acceptably reduce the potential for CO2
rebreathing, consider an alternative means of ventilation.
•
Increase EPAP to decrease the potential for CO2 rebreathing. Higher
pressures produce more flow through the exhalation port, which helps
to purge all CO2 from the circuit to prevent rebreathing.
•
Be aware that the potential for CO2 rebreathing increases as
inspiratory time increases. A longer inspiratory time decreases
exhalation time, allowing less CO2 to be purged from the circuit before
the next cycle. In such circumstances, higher tidal volumes further
increase the volume of CO2 rebreathed by the patient.
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.
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Chapter 3
General information
Contraindications
General description
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)
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 patients.
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
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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 RespiLink interface permits software upgrade and remote troubleshooting of the
ventilator through the RS-232 port.
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Chapter 3
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. Table 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.
Oxygen
monitor
Bacteria filter
Patient circuit
Exhalation port
Humidifier
Mask
Oxygen
cylinder
Figure 3-2: Respironics V60 Ventilator with accessories
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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 Appendix D or the equivalent
Inspiratory filter
Respironics main flow (inspiratory) bacteria
filter listed in Appendix D or the equivalent
Humidifier
• Fisher & Paykel MR810 or MR850
• Hudson RCI CONCHATHERM or
CONCHATHERM Neptune
Oxygen monitor
• CRITERION OxiCheck oxygen analyzer
(PN 8-100661-00)
• Teledyne MX300 oxygen monitor
• An equivalent that complies with
ISO 7767
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