Penlon AV900 User Manual

AV900 Ventilator V.4

User Manual

Partnership for Life

AV900 Version 4 Software

Servicing and Repairs

In order to ensure the full operational life of this
ventilator, servicing by a Penlon-trained
engineer should be undertaken periodically.

The ventilator must be serviced to the following
schedule:

(a) Six monthly service - inspection and

function testing.
(b) Annual service.
(c) Five year major service including battery

replacement.
Details of these operations are given in the

AV900 Service Manual, available only for
Penlon trained engineers.

For any technical enquiry regarding the
servicing or repair of this product, contact the
nearest accredited Penlon agent:

or communicate directly with:
Technical Support

Penlon Limited
Abingdon Science Park
Barton Lane
Abingdon
OX14 3PH
UK

Tel: [phone]
Fax: [phone]

E-mail: [e-mail]

Always give as much of the following
information as possible:

1. Type of equipment

2. Product name

3. Serial number

4. Software revision number

5. Approximate date of purchase

6. Apparent fault

IMPORTANT

(i)

This manual has been produced to provide
authorised personnel with information on the
function, routine performance and
maintenance checks applicable to the AV900
Anaesthesia Ventilator with version 4
software.

Information contained in this manual is
correct at the date of publication.
The policy of Penlon Limited is one of
continued improvement to its products.
Because of this policy, Penlon Limited
reserves the right to make any changes
which may affect instructions in this manual,
without giving prior notice.

Personnel must make themselves familiar
with the contents of this manual and the
machine’s function before using the
apparatus.

Copyright © Penlon Limited, 2005
All rights reserved

FOREWORD

(ii)

THE IMPORTANCE OF PATIENT
MONITORING

WARNING

Anaesthetic systems have the
capability to deliver mixtures of gases
and vapours to the patient which could
cause injury or death unless controlled
by a qualified anaesthetist.

There can be considerable variation in
the effect of anaesthetic drugs on
individual patients so that the setting
and observation of control levels on
the anaesthesia systems does not in
itself ensure total patient safety.

Anaesthesia system monitors and
patient monitors are very desirable
aids for the anaesthetist but are not
true clinical monitors as the condition
of the patient is also dependent on his
respiration and the functioning of his
cardio-vascular system.

IT IS ESSENTIAL THAT THESE
ELEMENTS ARE MONITORED
FREQUENTLY AND REGULARLY AND
THAT ANY OBSERVATIONS ARE
GIVEN PRECEDENCE OVER MACHINE
CONTROL PARAMETERS IN JUDGING
THE STATE OF A CLINICAL
PROCEDURE.

Page No.

USER RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1. WARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

2. PURPOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3. DESCRIPTION

3.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.2 Ventilation Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

3.3 Pneumatic System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.3.1 System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.3.2 Compliance Compensation and Fresh Gas / Mixture Compensation . . . . . . . 13

3.3.3 User Selectable Inspiratory Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.3.4 Automatic Altitude Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.3.5 Patient Gas Pressure Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.3.6 High Pressure Protection . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.3.7 Spirometry . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.4 Oxygen Monitor (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3.4.1 System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3.4.2 The MOX-3 Oxygen Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3.4.3 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3.4.4 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3.4.5 Alarm Mute. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3.5 Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

3.5.1 System Controls and Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

3.5.2 Power Switch (including Interface with Prima SP) . . . . . . . . . . . . . . . . . . . 18

3.5.3 Touchscreen Operation and Navigator Wheel / Push Button . . . . . . . . . . . . . 20

3.5.4 On-screen Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

3.5.5 Mode Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

3.5.6 Tidal Volume Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

3.5.7 Ventilation Rate Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

3.5.8 Ventilation I:E Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

3.5.9 Airway Pressure Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

3.5.10 Electronic Positive End Expiratory Pressure (PEEP) . . . . . . . . . . . . . . . . . . . . 29

3.5.11 Alarm Mute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

3.5.12 Inspiratory Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

3.5.13 Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

3.5.14 A100 Absorber with Bag/Ventilator Mode Detection Switch . . . . . . . . . . . . . . 30

3.5.15 Waveform Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

3.6 Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

3.7 Alarms and Message Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

3.8 Back-up Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

3.9 Operational Capability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

4. SPECIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Oxygen Monitor . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

CONTENTS

(iii)

CONTENTS

(iv)

5. PRE-OPERATION PROCEDURES

5.1 Ventilator Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

5.1.1 Components Supplied with the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . 44

5.1.2 Mounting the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

5.1.3 Electrical Power Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

5.1.4 Gas supply, breathing system connections and start-up . . . . . . . . . . . . . . . . . . 44

5.1.5 Spirometer Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

5.1.6 Spirometer Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

5.2 Bellows Assemblies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

5.3 Pre-use Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.3.1 Daily Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.3.2 Weekly Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

5.4 Oxygen Monitor Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

5.4.1 Installation . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

5.4.2 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

5.4.3 Sensor Low Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

5.4.4 Setting the High and Low O

2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

6. CLINICAL OPERATION

6.1 Before Using the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

6.2 Setting the Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

6.3 Positive End Expiratory Pressure (PEEP) . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

6.4 Bellows Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

7. USER MAINTENANCE

7.1 Service Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

7.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

7.3 Spirometer Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

7.4 Sterilisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

7.5 Oxygen Monitor - Cleaning and Sterilisation. . . . . . . . . . . . . . . . . . . . . . . . . 67

7.6 Oxygen Sensor Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

8. ORDERING INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

9. APPENDIX

Back-up Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Print-out Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Ventilator Alarms -Theory of Operation . . . . . . . . .. . . . . . . . . . . . . . . . . . 72

This anaesthesia ventilator has been built to
conform with the specification and operating
procedures stated in this manual and/or
accompanying labels and notices when
checked, assembled, operated, maintained
and serviced in accordance with these
instructions.

To ensure the safety of this device it must be
checked and serviced to at least the
minimum standards laid out in this manual.
A defective, or suspected defective, product
must not under any circumstances be used.

The user must accept responsibility for any
malfunction which results from non­compliance with the servicing requirements
detailed in this manual.

Additionally, the user must accept
responsibility for any malfunction which may
result from misuse of any kind or non­compliance with other requirements detailed
in this manual.

Worn, broken, distorted, contaminated or
missing components must be replaced
immediately. Should such a repair become

necessary it is recommended that a request
for service advice be made to the nearest
Penlon accredited agent.

This device and any of its constituent parts
must be repaired only in accordance with
written instructions issued by Penlon
Limited and must not be altered or modified

in any way without the written approval of
Penlon Limited. The user of this equipment
shall have the sole responsibility for any
malfunction which results from improper
use, maintenance, repair, damage or
alteration by anyone other than Penlon or its
appointed agents.

USAand Canadian Federal Law restricts the
sale and use of this device to, or on the order
of, a licensed practitioner.

Statements in this manual preceded by the
following words are of special significance:

WARNING means there is a

possibility of injury to the
user or others.

CAUTION means there is a possibility

of damage to the apparatus

or other property.

NOTE indicates points of

particular interest for more
efficient and convenient

operation.

Always take particular notice of the
warnings, cautions and notes provided
throughout this manual.

USER RESPONSIBILITY

1

1. WARNINGS AND CAUTIONS

The following WARNINGS and CAUTIONS
must be read and understood before using
this ventilator.

WARNINGS

General Information

1. Personnel must make themselves

familiar with the contents of this

manual and the machine’s function

before using the ventilator.

Before Using the Ventilator

2. Before the ventilator is used clinically

for the first time, verify that the hospital

engineering department has carried out

an earth continuity test.

3. Excessive electronic noise caused by

other poorly regulated devices, such as

an electrocautery unit, may adversely

interfere with the proper functioning of

the ventilator.

To avoid this problem, do not connect

the ventilator’s power cord into the

same electrical wall outlet or adaptor

strip into which an electrocautery unit

is connected.

4. If used with a mains extension cord, the

unit may be subject to electro-magnetic

interference.

5. The driving gas supply must be clean

and dry to prevent ventilator

malfunction.

6. This ventilator is designed to be driven

by oxygen or medical air only. It is

calibrated during manufacture for use

with either gas.

Before the ventilator is used clinically

for the first time, the commissioning

engineer must confirm that the internal

Air/Oxygen switch is set correctly for

the gas that is to be used.

The use of any other gas will cause

inaccurate operation and may damage

the ventilator, resulting in potential

injury to the patient.

7. The driving gas is discharged through
the opening in the back of the ventilator
control unit.
The discharged gas may contaminate
the environment, and should therefore
be extracted using a gas scavenging
system.

8. The bellows can only support
approximately 1 kPa (10 cmH

2

O)
differential positive pressure, above
which it may be dislodged from the
mounting ring, resulting in dangerous
malfunction of the ventilator.

Do not connect a PEEP valve or other
restrictive device to the exhaust port on
the bellows base.

This would increase the pressure inside
the bellows and the bellows could
detach from the base, causing serious
malfunction.

9. The breathing system which conveys
gases from the anaesthetic machine to
the patient, and disposes of expired
gases, is a vital part of the anaesthetic
delivery system.
Because breathing systems require
frequent cleaning and disinfection they
are not a permanent part of the
anaesthetic ventilator and therefore
cannot be directly under the control of
the anaesthetic ventilator manufacturer.
However, we strongly recommend that
only breathing systems which have
been approved and authorised by
Penlon for use with AV900 should be
employed.

Do not use conductive breathing
system hoses.

When mechanical ventilation is
employed the patient breathing system
must be connected directly to a
pressure relief valve to prevent the
possibility of barotrauma.

10. Do not connect a spirometer to the
exhaust port on the bellows base.
The device will not measure exhaled
volumes in that position.

2

11. The operation of each alarm function
should be verified daily.

Periodically check the alarms at
clinically suitable intervals. If the
audible alarm or the visual indicator of
any alarm function fails to activate
during any alarm condition or fails to
reset after the alarm has been cleared,
refer the unit to an authorised service
technician.

12. Before using the ventilator check that
all connections are correct, and verify
that there are no leaks.

Patient circuit disconnects are a hazard
to the patient. Extreme care should be
taken to prevent such occurrences.

It is recommended that Penlon
Safelock fittings are used throughout
the breathing circuit.

Using the Ventilator

13. This apparatus must not be used with,
or in close proximity to, flammable
anaesthetic agents.
There is a possible fire or explosion
hazard.

14. Anaesthesia apparatus must be
connected to an anaesthetic gas
scavenging system to dispose of waste
gas and prevent possible health
hazards to operating room staff. This
requirement must be observed during
test procedures as well as during use
with a patient.
Any problem arising from an
improperly functioning scavenging
system is solely the user’s
responsibility.

15. When the ventilator is connected to a
patient, it is recommended that a
qualified practitioner is in attendance
at all times to react to an alarm or other
indication of a problem.

16. In compliance with good anaesthesia
practice, an alternative means of
ventilation must be available whenever
the ventilator is in use.

17. The basic model AV900 is not equipped
with an oxygen analyser.
It is recommended that the patient
oxygen concentration should be
monitored continuously, at or near the
proximal airway with an oxygen
monitor that includes high/low alarms.

18. If the drive gas supply pressure drops
below a nominal 241 kPa (35 psi), the
LOW DRIVE GAS SUPPLY alarm will
activate both audibly and visually.
Patient minute volume may be reduced
due to lowered flow rates

19. An audible alarm indicates an
anomalous condition and should never
go unheeded.

20. The characteristics of the breathing
circuit connected between the
ventilator and the patient can modify or
change patient ventilation.
To assist the maintenance of the
delivered patient tidal volume, the
ventilator control system software
includes:
A) a compliance compensation
algorithm,
B) a fresh gas compensation
algorithm.

However, patient ventilation must be
monitored independently from the
ventilator.
It is the responsibility of the user to
monitor patient ventilation.

21. On models with spirometry, care must
be taken to ensure that the flow
sensors are connected correctly to the
inspiratory and expiratory ports of the
absorber.

22. The Vent Inop (ventilator inoperative)
alarm indicates that one of the
following conditions has occurred:
A) The drive gas solenoid has failed.
B) The flow control valve has failed.
C) Internal electronic fault.
D) Internal electrical fault.
E) Software error.
Note that if a ventilator error is
detected, an error code will be
displayed on the front control panel
display.

WARNINGS AND CAUTIONS

3

23. The High and Low Airway Pressure
Alarms are important for patient care.
The ventilator is designed to be used
with a distal sensing tee only.
(Catalogue No. 53194, Breathing
System Tee Assembly - see section 8).

It is important that the distal sensing
tee is properly located in the expiratory
limb of the circuit between the patient
and the expiratory one way valve.
See section 5.1.4.

24. The patient must be continuously

attended and monitored when Patient
Support Mode is in use.

User Maintenance

Control Unit

25. Opening the control unit by
unauthorised personnel automatically
voids all warranties and specifications.

Prevention of tampering with the
control unit is exclusively the user’s
responsibility. If the control unit seal is
broken, the manufacturer assumes no
liability for any malfunction or failure of
the ventilator.

26. For continued protection against fire
hazards, replace the two fuses only
with the identical type and rating of
fuse.
See section 4.41 for fuse rating.

27. If the internal battery is fully
discharged, the ventilator will not
function in the event of mains power
failure. The battery must be recharged
before the ventilator is used clinically,
otherwise backup cannot be
guaranteed.
See section 9 for battery maintenance.
See also CAUTION No. 7.

Used or defective batteries must be
disposed of according to hospital,
local, state, and federal regulations.

28. No oil, grease or other flammable
lubricant or sealant must be used on
any part of the ventilator in close
proximity to medical gas distribution
components.
There is a risk of fire or explosion.

29. Exterior panels must not be removed
by unauthorised personnel and the
apparatus must not be operated with
such panels missing.
There is a possible electric shock
hazard.

Bellows Assembly

30. The valve seat on the patient gas
exhalation diaphragm valve in the base
of the bellows assembly must be
cleaned regularly - see section 7.2.
Failure to keep the valve seat clean
could result in the diaphragm sticking,
thus preventing exhalation.

Great care must be taken not to
damage the precision surface of the
valve seat on the patient gas exhalation
diaphragm valve in the base of the
bellows assembly.

Never use any hard object or abrasive
detergent to clean it; use only a soft
cloth.
If the valve seat is damaged, the valve
will leak and may cause serious
ventilator malfunction.

WARNINGS AND CAUTIONS

4

CAUTIONS

1. Do not sterilise the ventilator control unit.
The internal components are not
compatible with sterilisation techniques
and damage may result.

2. For ventilator components which require
sterilisation, peak sterilisation
temperatures should not exceed 136oC
(275oF) to prevent possible damage.
(See sections 7.2 and 7.3).

3. Those parts suitable for ethylene oxide
sterilisation should, following sterilisation,
be quarantined in a well ventilated area to
allow dissipation of residual gas absorbed
by the components.
Follow the steriliser manufacturer’s
recommendations for any special aeration
periods required.

4. The exhalation valve located in the
bellows base assembly and the paediatric
bellows adaptor must be cleaned and
sterilised separately. See sections 7.2 and

7.3.

5. Care must be taken not to let any liquid
run into the control unit; serious damage
may result.

6. Always check for correct fitment, and carry
out a full function test before clinical use, if
the bellows has been removed and
refitted for any reason. See sections 5.2
and 7.2.

7. Damage may occur to the battery if it is
allowed to remain in a discharged state.
Check the battery frequently if the
ventilator is in storage (see Appendix 1).

8. On models with spirometry, fresh gas

compensation is disabled if :
a) The spirometry system is turned OFF
through the menu system, or
b) The spirometry system is not functioning
correctly.

9. On models with spirometry, fresh gas

mixture compensation is disabled if :
a) The spirometry system is turned OFF
through the menu system, or
b) The spirometry system is not functioning
correctly.

c) The O2 monitor is switched OFF.

10. NOTE: On models with spirometry, circuit

compliance is not activated until Fresh
Gas Compensation is switched OFF.

WARNINGS AND CAUTIONS

5

Oxygen Monitor

WARNINGS

1. We recommend calibration of the
oxygen monitor every time the system
is turned on, as a safety precaution.

2. Do not attempt to open the fuel cell.
The sensor contains small quantities
of :
a) electrolyte, classified as a harmful
irritant which is potentially hazardous,
and
b) lead.

Used or defective cells must be
disposed of according to hospital,
local, state, and federal regulations.

3. ALWAYS check the integrity of the
sensor assembly before use. See
section 3.4.

4. Once exhausted, the sensor must be
disposed of according to hospital,
local, state and federal regulations.

5. The sensor measures oxygen partial
pressure, and its output will rise and
fall due to pressure change.
An increase in pressure of 10% at the
sensor inlet will produce a 10%
increase in sensor output.

CAUTIONS

1. Do not sterilise the oxygen sensor or
control unit components.
These components are not compatible
with sterilisation techniques and damage
may result.

2. Do not autoclave or expose the sensor to
high temperatures.

3. If the sensor shows signs of being affected
by condensation, dry the sensor with soft
tissue.
Do not use heat to dry the sensor.

6

NOTES

1. The O2 SENSOR FAULT alarm indicates
that one of the following conditions has
occurred.
a) Internal electrical fault
b) Software/electronics fault
c) Oxygen sensor fault.

2. The concentration read-out may, in
certain conditions of excess pressure,
show a value above 100%.
To accommodate these conditions it is
possible to set the high alarm value up to
105% (see section 5.4.4).

3. To maintain maximum sensor life, always
remove the unit from the breathing circuit
after use.

4. The accuracy of flow and volume
measurements may be reduced if the
oxygen monitor is not in use.

5. Fresh gas mixture compensation is disabled

if the oxygen monitor is switched OFF.

WARNINGS AND CAUTIONS - Oxygen Monitor

The AV900 Ventilator is a software
controlled, multi-mode ventilator, designed
for mechanical ventilation of adult and
paediatric patients under general
anaesthesia.
In addition, in spontaneous mode, it can be
used to monitor spontaneously breathing
patients
It is designed for use in closed-circuit
anaesthesia and also to drive a Mapleson D
circuit.

Indications for use of the device:

The AV900 Ventilator is intended to provide
continuous mechanical ventilatory support
during anaesthesia. The ventilator is a
restricted medical device intended for use by
qualified trained personnel under the
direction of a physician. Specifically the
ventilator is applicable for adult and
paediatric patients.
The ventilator is intended for use by health
care providers, i.e. Physicians, Nurses and
Technicians with patients during general
anaesthesia

Oxygen Monitor (optional)

The Oxygen Monitor is intended to
continuously measure and display the
concentration of oxygen in breathing gas
mixtures used in anaesthesia, and is
intended for adult and paediatric patients.
The oxygen monitor is a module within an
anaesthesia machine, and is a mandatory
module when the spirometry option for
AV900 is specified.
The oxygen monitor is intended for use by
health care providers, i.e. Physicians,
Nurses and Technicians for use with p atients
during general anaesthesia.

2. PURPOSE

7

3.1 General Description

The AV900 is a time-cycled,
volume/pressure controlled, and pressure
limited ventilator for closed circuit ventilation
or for use with a Mapleson D circuit.

The ventilator is compliance compensated
and has a user selectable option of an
inspiratory pause fixed at 25% of the
inspiratory time.
In addition, models with spirometry are fresh
gas compensated and also feature user
selectable gas mixture compensation.

The print function provides a permanent
record of function activity for up to eight
hours during a procedure, or can be used to
record waveforms.

The bellows unit can be easily detached and
then refitted to the bellows base assembly to
facilitate cleaning.

Drive gas supply

The ventilator drive gas supply can be
oxygen or air. The supply must be at 262 to
689 kPa (38 to 100 psi ). Note that the drive
gas is specified by the customer prior to
delivery. Conversion from one drive gas to
another must be carried out by a Penlon­trained service engineer.

Options

a) Spirometry, and an integral oxygen
monitor to measure oxygen concentration in
the breathing circuit.
Note that on models without spirometry, the
patient support function is disabled.

b) Paediatric bellows assembly.
c) Mounting options - the AV900 can be

mounted on the anaesthetic machine as a
single, complete unit, or the bellows unit and
the control unit can be mounted separately .

3. DESCRIPTION

Bellows Base

Control Unit

Bellows Housing

8

AV900 Ventilator

9

Rear Panel and Gas Ports

Bellows Drive Gas Inlet
Port
Do NOT connect
spirometer

Pressure Monitor Port
Input socket - Oxygen

monitor sensor
Data Output

Outlet - Exhaust Valve
Electrical mains input

and fuse unit

Breathing System

Port

Spirometer

connector

Prima SP Interface

connector

RS232 Port

Printer Port

Connect to cylinder

or pipeline supply

Connect to Bellows

Drive Gas Inlet Port

DESCRIPTION

3.2 Ventilation Cycle

This section provides a simplified description of the ventilation cycle.

1. Inspiratory
Phase

Drive gas pressure
builds up above
the bellows, which
starts to move
down, forcing
patient gas into the

breathing system.

2. End of Inspiratory
Phase

The main drive gas valve
closes and the bellows
stops moving.

NOTE
Inspiratory Pause
(Volume Mode only, user
selectable)
Inspiratory pause holds the
inspiratory phase at the end
of inspiration, for a period of
25% of the inspiratory time
before reverting to expiratory
phase.
See section 3.3.3.

DESCRIPTION

MAIN DRIVE
GAS VALVE
CLOSED

DRIVE GAS IN

PATIENT
GAS OUT TO
BREATHING
CIRCUIT

10

DESCRIPTION

3. Beginning of
Expiratory Phase

The exhaust valve opens, allowing the
drive gas above the bellows to escape
to atmosphere.

The bellows starts to rise and exhaled
gas enters the bellows.

4. End of Expiratory Phase

The bellows exhalation diaphragm
valve in the base of the bellows
assembly opens when the bellows
reaches the top of the chamber.
Patient circuit gas exits through the
bellows assembly exhaust port, and
then through the ventilator exhaust
valve.

5. PEEP - Positive

End Expiratory
Pressure
(user selectable)

During PEEP, the bellows exhalation
diaphragm valve is closed.
Fresh gas flows in the patient circuit.
Pressure in the bellows increases.
The PEEP proportioning valve will
maintain the pressure with a
controlled bleed flow.

EXHAUST VALVE

11

EXHAUST
VALVE OPEN

PEEP VALVE
OPEN

BELLOWS
EXHALATION
DIAPHRAGM
VALVE

BELLOWS
EXHALATION
DIAPHRAGM
VALVE CLOSED

PNEUMATIC SYSTEM DIAGRAM

1. Gas supply 10. Exhaust outlets

2. Input gas filter 11. Pressure relief valve

3. Low supply pressure detector 12. Exhaust valve

4. Input pressure regulator 13. Proportional valve

5. Test point 14. Drive gas over-pressure switch

6. Inspiratory valve 15. Outlet to bellows assembly

7. Drive gas flow metering valve 16. Pressure transducer

8. Stepper motor and feedback 17. Inlet from breathing circuit
potentiometer (for 7)

9. Expiratory valve

12

1

2

3

4

5

6

7

8

9

11

12

13

14

15

16

17

10

DESCRIPTION

Needle Drive Manifold Block

Exhaust Manifold Block

3.3 Pneumatic System

3.3.1 System Operation

Refer to the pneumatic system diagram on the
previous page.

The AV900 Ventilator is designed to operate on
a 262 - 689 kPa (38 -100 psi) drive gas supply
(oxygen or air - to customer’s requirement).
The gas source is connected to the DRIVE
GAS SUPPLY DISS fitting on the rear of the
ventilator control unit.
The gas supply should be capable of a flow rate
of 80 L/min while maintaining a minimum
pressure in excess of 262 kPa (38 psi).

The drive gas is filtered with a 40-micron Input
Gas Filter which protects the pneumatic
components from incoming particulate matter.

The Low Supply Pressure Detector is a
pressure switch set at a predetermined level to
detect a loss or reduction of the input gas source
pressure.
When the pressure falls below 243 kPa (35 psi),
the LOW SUPPLY PRESSURE indicator will be
displayed and the high priority audible alarm will
activate.

The Input Pressure Regulator conditions the
input drive gas to 221 kPa ± 21 kPa (32 psi ± 3
psi) which will operate the internal pneumatic
system.

The Inspiratory Valve is an electro­pneumatically-driven valve with a large orifice.
The valve supplies the drive gas to the Drive
Gas Flow Metering Valve .

The Expiratory Valve operates as a pilot valve
for the exhaust valve.

The Drive Gas Flow Metering Valve is a
variable-orifice needle valve which determines
the drive gas flow rate to the bellows during
inspiration.

The V alve Position Feedback Potentiometer and
the Flow Control Motor function together to set
a flow rate as required by the front panel
controls.

The flow from the Drive Gas Flow Metering
Valve goes to the Bellows Assembly, via the
drive connector.
The flow then closes the exhalation diaphragm
valve and pushes the bellows downward.
As the bellows moves downwards, the gas

inside the bellows is forced into the Breathing
System.

At the end of inspiration the exhaust valve
opens and allows the drive gas in the top of the
bellows housing to exhaust out through the
Exhaust Outlet.

As the pressure in the top of the bellows housing
is reduced to zero, the patient exhales into the
breathing system and the bellows rises.

3.3.2 Compliance Compensation and
Fresh Gas / Fresh Gas Mixture
Compensation

WARNING
The AV900 has circuit compliance
compensation (and fresh gas compensation
on models fitted with spirometry).
However, the actual tidal volume delivered to
the patient may be different to the ventilation
parameters set by the user, due to:

A) an extreme compliance condition,
B) a substantial system leak,
C) patient circuit pressure effects, or
D) extreme fresh gas flows

In addition, high fresh gas flows will lead to
an increased Vt being delivered to the
patient.
Note that on models fitted with spirometry,
the actual tidal volume exhaled will be
displayed.
The patient must

be monitored
independently from the ventilator.
It is the responsibility of the user to monitor
the patient for adequate ventilation.

Circuit Compliance Compensation

A compliance compensation algorithm is built
into the control software which monitors the
volume of gas delivered and the rate of
pressure rise.
It calculates an additional volume to deliver into
the breathing system to compensate for the
reduced volume delivered to the patient as a
result of the increased breathing system
pressure.
As a safety feature, this additional volume is
restricted to a maximum of 15% of the set tidal
volume irrespective of the maximum pressure
rise.

NOTE: On models with spirometry, circuit
compliance compensation is not activated until
Fresh Gas Compensation is switched OFF.

DESCRIPTION

13

DESCRIPTION

Fresh Gas Compensation - models with
Spirometry

A fresh gas compensation algorithm is built into
the control software.
Delivered volume will be altered by up to 45% to
allow compensation for fresh gas.

Fresh gas compensation is disabled if :
a) The spirometry system is turned OFF through
the menu system, or
b) The spirometry system is not functioning
correctly.

Fresh Gas Mixture Compensation

- models with Spirometry

The spirometry system compensates for fresh
gas mixture - the user must access the menu
system and select the gas mixture that will be
used for each clinical procedure.
Fresh gas mixture compensation is disabled if :
a) The spirometry system is turned OFF through
the menu system, or
b) The spirometry system is not functioning
correctly.

c) The O

2 monitor is switched OFF.

3.3.3 User Selectable Inspiratory
Pause

A user selectable inspiratory pause is
provided which, when activated, holds the
inspiratory phase at the end of inspiration, for a
period of 25% of the inspiratory time before
reverting to the expiratory phase.

NOTE
Inspiratory Pause function is not available in
PRESSURE mode and SPONTANEOUS mode.

3.3.4 Automatic Altitude
Compensation

Ambient pressure is monitored and the
ventilator automatically compensates the
delivered volume according to the local
atmospheric pressure.

3.3.5 Patient Gas Pressure
Transducer

The Patient Gas Pressure Transducer is
connected to the patient breathing system via
the rear panel.

In VOLUME CYCLE mode whenever this
pressure exceeds the maximum working
pressure as set on the front panel, an alarm is
activated and the following occurs:

1. The HIGH AIRWAY PRESSURE visual

indicator is illuminated (high priority
alarm).

2. The audible alarm is activated (high
priority alarm).

3. The Inspiratory Valve is closed, the
exhaust valve is opened, and the
inspiration cycle is ended.

Note:
The rate of breaths per minute will be
affected in this condition as the
ventilator will cease to deliver flow
above the maximum working pressure.

WARNING
If this alarm is ignored, the patient may
receive an insufficient minute volume.

In PRESSURE controlled mode, when the set
pressure is reached the following occurs:

1. The Inspiratory valve is closed.

2. The ventilator maintains the set

pressure until the end of the
inspiration cycle.

3.3.6 High Pressure Protection

High pressure in the ventilator is limited by
three independent protective systems.

1. The Pressure Transducer has already
been described.

2. The Driving Gas Over-pressure Switch is
set at 80 cmH

2O and will shut off drive gas

flow at this value.

3. The Pressure Relief Valve is a mechanical
over-pressure relief which will open at 80
cmH

2O, diverting the driving gas to

atmosphere through the exhaust port.

The Exhaust Outlet on the back of the control
unit accepts the drive gas exhaust from all
internal pneumatic components.

3.3.7 Spirometry System

Spirometry (if fitted) can be enabled, or disabled
via the on-screen menu system.

NOTE
If the spirometry system is turned OFF:
a) Fresh gas / fresh gas mixture compensation
is disabled.
b) Patient support function is disabled.

14

DESCRIPTION - O2 Monitor

3.4 Oxygen Monitor
(Optional)

The oxygen monitor continuously measures and
indicates the concentration of oxygen in the
breathing system, and triggers an alarm when the
concentration varies from the set levels.

3.4.1 System Description

The Oxygen Monitor uses a fast-responding,
oxygen-specific, self powered sensor that
achieves 90% of final value in less than 10
seconds.

An external probe is supplied with a 2 m (6 ft)
extendable cable and diverter fitting. The probe
has a safety lock.

The system has user-adjustable high-level and
low-level alarms with visual and audible indication
of alarm conditions.

3.4.2 The MOX-3 Oxygen Sensor

The MOX-3 oxygen sensor offers quick response,
linear output over the entire 0-100% oxygen
range, and long service life.

The MOX-3 is a self-powered galvanic cell that
generates a current proportional to oxygen
concentration.

The cell has a highly stable output over its
operating life. Significant output loss is only
shown at the very end of its life.
Typical sensor drift rates are less than 1% per
month when the sensor is exposed to gas in
typical applications.

Sensor life:

approximately 1 500 000 O2 percent hours
at 20

o

C
(minimum one year in most normal
applications).

Sensor lifetime is governed by the mass of lead
available to react with the oxygen and its rate of
consumption. High oxygen partial pressure and
high temperature will increase the sensor output
current, thus shortening the operation life.

At the point where all lead has been consumed,
the output will fall very quickly to zero over a
period of two to three weeks.

15

Sensor

Sensor Location

1. Prima SP with A100SP Absorber

Please refer to the datasheet, Doc No A100SP
103DS(U), supplied with the absorber.

2. Mounted on the dome of the
absorber inspiratory valve

3. ‘T’ piece adaptor on CGO block

DESCRIPTION - O2 Monitor

3.4.3 Display

High-set, low-set, and oxygen concentration
percentage readings are displayed on screen.

Oxygen Concentration

The display provides a direct readout of
measured oxygen concentrations in the range
0-100%.

Low Alarm Set - limited within 18-99%

The oxygen percentage, set by the user, at
which the low alarm will be activated.
To set the low oxygen alarm, see section 5.4.4

High Alarm Set - limited within 19-105%

The oxygen percentage, set by the user, which
the high alarm will be activated.
Note that in certain conditions of excess
pressure, the readout may show a value above
100%.
To set the high alarm, see section 5.4.4.

3.4.4 Oxygen Monitor Alarms

HIGH O2

ALARM

The high O2 alarm is triggered when the oxygen
concentration is 1% above the set value.

a) The High O

2 Alarm visual indicator will

illuminate.
b) Ahigh priority audible alarm will sound.
To cancel this alarm, the high alarm setting must

be equal to, or above the oxygen concentration.
The alarm can be muted for 120 seconds.

LOW O2 ALARM

The low alarm is triggered when the oxygen
concentration is 1% below the set value.

a) The Low O

2 Alarm visual indicator will

illuminate.
b) Ahigh priority audible alarm will sound.
To cancel this alarm, the low alarm setting must

be equal to, or below the oxygen concentration.
The alarm can be muted for 120 seconds.

O2 SENSOR FAULT

The alarm is triggered:
i) when either the oxygen sensor is

disconnected or approaching the end of its life.
ii) if the O

2 concentration exceeds 110%.

a) The legend O2 SENSOR FAULT will
illuminate.

b) Ahigh priority audible alarm will sound.
To cancel this alarm, check the sensor

connection or replace the sensor.
The alarm can be muted for 120 seconds.

O2 SENSOR LOW

This alarm indicates the sensor has approached
the end of its life.
The legend O2 SENSOR LOW will be displayed,
and a low priority alarm (single note) will sound.

The sensor must be replaced as the output will
fall very quickly to zero within two to three weeks
of normal usage.
See section 7.5 for sensor replacement.

3.4.5 Oxygen Monitor Alarm Mute

In an alarm condition, pressing the ALARM
MUTE button will deactivate the audible alarm
but the alarm message display will remain on
screen.
The switch will illuminate, and a single note will
sound.

The alarm mute can not be operated:
a) Until the mute time is over, or the alarm

condition has been rectified.
b) When O

2 concentration drops below 18%.

%O2

25

100

20

Measured O2
concentration

High Alarm Set
Value

Low Alarm Set
Value

16

Oxygen Monitor Display

DESCRIPTION

17

3.5 Control Unit

3.5.1 System Controls and Parameters

Ventilator parameters:

VENTILATION MODE TIDAL VOLUME
RATE I:E RATIO
AIRWAY PRESSURE CONTROL ELECTRONIC PEEP
MENU FUNCTION WAVEFORM DISPLAY
INSPIRATORY PAUSE

(volume cycle mode only)

The parameters default to factory-set values when the ventilator is switched
on (see 3.5.2).

The parameters can be activated and new values assigned by using the
touchscreen and navigator wheel (see 3.5.3).

Based on the control settings, the system:

1. Calculates INSPIRATORY FLOW, and the INSPIRATORY and
EXPIRATORY times (see section 3.7).

2. Controls the flow metering valve.

3. Displays values for tidal volume or minute volume, rate, and I:E Ratio on
the front panel.

4. Generates the appropriate messages and alarms.

Oxygen Monitor parameters

O2 High Alarm
O

2 Low Alarm

The parameters are set via the menu system (see 3.5.4)

V

T

SET

millilitres

600

RATE

BPM

10

I : E

RATIO

1: 2.0

PEEP

cmH2O

OFF

LIMIT

cmH2O

38

PRESSURE

MODE

SPONT

MODE

VOLUME

CYCLE

STANDBY

V

T

MEASD

PRINTINSP

PAUSE

WAVE

FREEZE

Pcm

H2O

Tsecs

%O

2

25

100

20

AV900

OFF

ON

~

touchscreen control

On/Off Switch

Alarm Mute

Menu Switch

Navigator Wheel
and
Press Button

Alarm Mute Countdown Indicator

MUTE:30

GAS MIXTURE

O2 + air

DESCRIPTION

18

3.5.2 Power Switch

OFF

Electrical Circuit Condition

Mains power disconnected

- all functions are unpowered.

Mains power connected

- the backup battery recharge circuit is live

- the yellow LED is illuminated.

Switch to OFF after use

To switch off, hold down the switch for at least one
second.
Screen display shows:

POWERING DOWN 5...4...3...2...1....

ON

The ventilator automatically initiates a three second
internal test sequence.

During this period,

- the ‘boot up’ screen is displayed, and

- the audible alarms will activate.

After the test sequence, the ventilator switches to
STANDBY mode and the following parameters
default to the values shown:

TIDAL VOLUME 600 ml

RATE 10 bpm
I:E RATIO 1:2
AIRWAY PRESSURE LIMIT 38 cmH2O

PEEP Off

Interface to Prima SP

The AV900V4 can be interfaced to the Prima SP
Anaesthetic Machine and A100SP Absorber through
a connection (A) at the rear of the ventilator control
unit.
The interface cable is plugged into the socket (B) on
the rear panel of the anaesthetic machine.

Prima SP Interface Function:

a) Turn the Prima Sp Gas Delivery Switch (C) to

ON.
The ventilator will power-up.

b) While the Prima SP power is ON, the Ventilator

can be turned OFF and ON, using the
ventilator On/Off switch, as described above.

c) Turn the Prima SP Gas Delivery Switch to OFF.

The ventilator will power-down.

On/Off Switch

Alarm Mute

Mains Power
Indicator

Menu Switch

Navigator Wheel
and
Press Button

AV900

OFF

ON

~

Front Panel Controls

C

A

B

STANDBY

The parameters listed above (ON) are active in STANDBY mode, to allow system set-up.
The following alarms are functional in STANDBY mode:

LOW SUPPLY PRESSURE
MAINS FAILURE
VENT INOP

LOW BATTERY
HIGH AIRWAY PRESSURE

Note: In STANDBY mode, this alarm is triggered at 80 cmH

2O

NEGA TIVE AIRWA Y PRESSURE
INCORRECT RATE/RATIO
O

2 High Alarm (O2 Monitor option)

O

2 Low Alarm (O2 Monitor option)

Sensor Fault (O

2

Monitor option)

DESCRIPTION

19

3.5.3 Touchscreen Operation and
Navigator Wheel / Push
Button

The functions/parameters shown on the
screen above can be activated by touching
the screen at the appropriate tab area.

NOTE
PATIENT SUPPORT is available in Spotaneous
mode only.

Variable parameters can then be altered by
rotating the navigator wheel.

When the required value is displayed, press
the active tab or

the wheel to confirm the

setting.

DESCRIPTION

Active Tabs

VTSET

millilitres

600

RATE

BPM

10

I : E

RATIO

1: 2.0

PEEP

cmH2O

OFF

LIMIT

cmH2O

38

V

T

MEASD

PATIENT

SUPPORT

PRINT

WAVE

FREEZE

%O2

25

100

20

AV900

OFF

ON

~

touchscreen control

Touchscreen Active Tabs

20

Turn the wheel to
alter the value of the
active parameter.

Press

to confirm the

setting

PRESSURE

MODE

SPONT

MODE

VOLUME

CYCLE

STANDBY