InterMed 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: [email protected]
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 theAV900
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 O2Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 non-
compliance 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 non-
compliance 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 cmH2O)
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 O2monitor 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 patients
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 Penlon-
trained 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
45678
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 electro-
pneumatically-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 Valve 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 O2monitor 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 cmH2O 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
cmH2O, 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