Penlon-Paragon AV-S User manual
AV -S Ventilator
Remote Display Module and Interface
for use with A200SPAbsorber
User Manual
Draft Copy
July 2005
No update will be given
Servicing and Repairs
In order to ensure the full operational life of this
ventilator, servicing by an engineer trained by
the manufacturer 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
Service Manual for the AV-S, available only for
engineers trained by the manufacturer.
For any enquiry regarding the servicing or
repair of this product, contact Paragon Service.
Paragon Service
W. Bennet Sreet
Saline
MI 48176
Always give as much of the following
information as possible:
1. Type of equipment
2. Product name
3. Serial number
4. Approximate date of purchase
5. 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 AV-S Anaesthesia
Ventilator.
Information contained in this manual is correct
at the date of publication.
The policy of the manufacturer is one of
continued improvement to its products.
Because of this policy, the manufacturer
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.
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.3.1 System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.4 Electrical System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.5 Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.5.1 Touchscreen Operation and Navigator wheel / push-button . . . . . . . . . . . . 16
3.5.2 User Adjustable Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.5.3 Operational capability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.5.4 Output Compensation Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.6 Interface with PrimaSP2 and A200SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.7 Ventilation Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.7.1 Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.7.2 Volume Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.7.3 Pressure Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.7.4 Spontaneous Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.7.5 PSV (Pressure Supported Ventilation) . . . . . . . . . . . . . . . . . . . . . . . 24
3.7.6 PEEP ( Positive End Expiratory Pressure) . . . . . . . . . . . . . . . . . . . . . . . 25
3.8 On-screen Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.9 Spirometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.10 Display Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.11 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.12 Oxygen Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.12.1 System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.12.2 The MOX-3 Oxygen Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.12.3 Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
3.12.4 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.12.5 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.12.6 Alarm Mute. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4. SPECIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Oxygen Monitor . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5. PRE-OPERATION PROCEDURES
5.1 Ventilator Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.1.1 Mounting the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
CONTENTS
(iii)
CONTENTS
(iv)
5.1.2 Electrical Power Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.1.3 Ventilator Gas Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.1.4 Breathing System Schematic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.1.5 Bellows Drive Gas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.1.6 Anaesthetic Gas Scavenging System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.1.7 Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.1.8 Breathing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.1.9 Spirometer Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.1.10 Pressure Monitor Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
5.1.11 Bellows Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
5.2 Pre-use Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5.2.1 Daily Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5.2.2 Function Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
5.2.3 Weekly Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5.3 Oxygen Monitor Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.3.1 Installation . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.3.2 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.3.3 Sensor Low Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.3.4 Setting the High and Low O
2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6. USER MAINTENANCE
6.1 Service Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.2.1 Outside Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.2.2 Bellows and Diaphragm Exhalation Valve . . . . . . . . . . . . . . . . . . . . . . . 53
6.2.3 Spirometer Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6.2.4 Patient Connector Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.3 Sterilisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
6.4 Oxygen Monitor - Cleaning and Sterilisation . . . . . . . . . . . . . . . . . . . . . . . 57
6.5 Oxygen Sensor Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
7. APPENDIX
1. Back-up Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
2. Menu System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
3. Ventilator Spirometry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
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 Paragon
Service.
This device and any of its constituent parts
must be repaired only in accordance with
written instructions issued by the
manufacturer and must not be altered or
modified in any way without the written
approval of the manufacturer. 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 the manufacturer.
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 positive end
expiratory pressure (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. Breathing System
The breathing system which conveys
gases from the anaesthetic machine to
the patient, and disposes of expired
gases, must conform to the
requirements of ISO 8835-2.
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 the
manufacturer for use with AV-S 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 Safelock
fittings are used throughout the
breathing circuit.
13. Check that the cable between the
control unit and remote display screen
unit is connected before use.
Always use a cable type recommended
by the manufacturer.
Using the Ventilator
14. The AV-S ventilator is not intended for
use in intensive care applications.
15. This apparatus must not be used with,
or in close proximity to, flammable
anaesthetic agents.
There is a possible fire or explosion
hazard.
16. Anaesthesia apparatus must be
connected to an anaesthetic gas
scavenging system (AGSS) 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.
The scavenging transfer and receiver
system must conform to ISO 8835-3.
Any problem arising from an
improperly functioning scavenging
system is solely the user’s
responsibility.
Do not use a scavenging system that
restricts drive gas flow when negative
pressure is exerted on it.
17. 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.
18. In compliance with good anaesthesia
practice, an alternative means of
ventilation must be available whenever
the ventilator is in use.
19. It is recommended that the patient
oxygen concentration should be
monitored continuously.
20. 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
21. An audible alarm indicates an
anomalous condition and should never
go unheeded.
22. 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.
23. Care must be taken to ensure that the
flow sensors are connected correctly
to the inspiratory and expiratory ports
of the absorber.
24. 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.
WARNINGS AND CAUTIONS
3
Note that if a ventilator error is
detected, ‘Ventilator Inoperative’will be
displayed on the front control panel
display.
25. The High and Low Airway Pressure
Alarms are important for patient care.
It is important that the sensor is
properly located in the expiratory limb
of the circuit - refer to section 5.1.10.
26. The patient must be continuously
attended and monitored when
Advanced Breathing Modes are in use.
User Maintenance
Control Unit
27. 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.
28. For continued protection against fire
hazards, replace the two fuses only
with the identical type and rating of
fuse.
See section 4 for fuse rating.
29. 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 Appendix for battery maintenance.
See also CAUTION No. 7.
Used or defective batteries must be
disposed of according to hospital,
local, state, and federal regulations.
30. 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.
31. 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
32. The valve seat on the patient gas
exhalation diaphragm valve in the base
of the bellows assembly must be
cleaned regularly - see section 6.2.
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 patient block assembly must be
removed from the control unit before
sterilisation ( see section 6.2.4).
All other 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 section 6).
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 section 6.
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 section 6.
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. 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. 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. Circuit compliance is not activated until
Fresh Gas Compensation is switched
OFF.
NOTES
1. The term ‘cycle’ is used to designate the
transition to the exhalation phase.
2. The term ‘trigger’ is used to indicate the
transition to the inhalation phase.
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.
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. Only use low temperature ethylene oxide
sterilisation for the oxygen sensor.
The sensor is not compatible with other
sterilisation techniques - damage may
result.
Do not sterilise any other components.
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).
3. To maintain maximum sensor life:
i) always switch off the anaesthetic
machine after use, to ensure that the basal
flow ceases.
ii) disconnect 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 AV-S 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 AV-S 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.
The AV-S ventilator is not intended for use in
intensive care applications.
Oxygen Monitor
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 an integral part of the
ventilator.
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 AV-S Ventilator is a pneumatically
driven, software controlled, multi-mode
ventilator.
The ventilator is a time-cycled,
volume/pressure controlled, and pressure
limited.
The ventilator has compliance compensation
and a user selectable option of an inspiratory
pause fixed at 25% of the inspiratory time.
In addition, fresh gas compensation and
user selectable gas mixture compensation is
a standard feature.
Ventilation Modes
Volume Mode - continuous mandatory
ventilation
Pressure Mode - pressure controlled
ventilation
Spontaneous, with advanced PSV (Pressure
Support Mode)
PEEP
Patient Monitoring
Airway pressure, measured from the
expiratory limb of the breathing circuit.
Tidal volume and Minute Volume
measurement is provided by a dual
spirometry system
An integral oxygen monitor system
measures oxygen concentration in the
breathing circuit inspiratory limb.
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.
Screen
210 mm (8.4 inch) high definition, colour TFT
screen, with single/dual waveform display.
Remote mounted on an arm.
3. DESCRIPTION
8
AV-S Ventilator
Bellows unit
The bellows unit (1) is built into the A200SP
absorber.
A paediatric bellows assembly is available as
an option
Mounting options
The AV-S integral screen and control unit can
be mounted securely on the anaesthetic
machine shelf or side bracket.
Drive gas supply
The supply must be at 310 to 689 kPa (45 to
100 psi ).
The ventilator drive gas supply can be oxygen
or air.
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 service engineer trained by the manufacturer.
DESCRIPTION
9
1
10
Control Unit
Rear Panel
Interface and Parameter inputs
5. A200SP Absorber Bag/Vent
switch interface
Spirometer connector
6. Prima SP2 Interface connector
7. Pressure Monitor Port
8. Input socket - Oxygen monitor
sensor
Data and Printer Ports
9. Data Output
10. Output to remote display
11. Ethernet
12. USB
13. VGA
14. Printer port
15. RS232
NOTE
USB port is for access only by engineers
trained by the manufacturer.
All other data ports are read only.
For further information, please contact
Paragon.
Gas Connections
1. Ventilator drive gas inlet
- connect to anaesthetic machine
auxiliary gas outlet
2. Bellows Drive Gas Output
- connect to bellows via A200SP
absorber - see section 5.1.5)
3. Outlet - Exhaust Valve
Electrical Connection
4. Electrical mains input and fuse unit
DESCRIPTION
2
7
3
13 14 15
12
1110
9
8
6
5
4
1
3.2 Ventilation Cycle
This section provides a simplified description of the ventilation cycle.
1. Inspiratory Phase
The inspiratory proportional
valve (1) in the control unit
opens, and bellows drive
gas is delivered to the
bellows housing (2).
The expiratory proportional
valve (3) opens and gas
flows through the bleed
valve. The back pressure
ensures that the exhaust
valve (4) is kept closed
Drive gas pressure builds
up above the bellows, which
starts to move down.
The diaphragm (5) in the
bellows assembly base is
held closed, and patient gas
is forced out of the bellows
base (6) into the breathing
system.
2. Beginning of
Expiratory Phase
The Inspiratory (1) and
Expiratory (3) proportional
valves close and the exhaust
valve (4) opens. Patient gas
returns to the bellows. As
the bellows rises, redundant
drive gas is pushed out
through the exhaust valve.
DESCRIPTION
11
1
4
4
5
6
2
3
3
1
3
1
4
DESCRIPTION
3. End of
Expiratory Phase
With the bellows at the top
of its housing fresh gas
continues to flow. To
prevent a high pressure
build up the exhalation
diaphragm (5) lifts and
allows gas to exit through
the exhaust valve (4).
4. PEEP
Positive End
Expiratory
Pressure
(user selectable)
During PEEP the Exhalation
Proportional valve (3)
applies PEEP pressure plus
20 cmH2O to the exhaust
valve, which remains closed
at this stage.
As fresh gas flows in the
patient circuit, any pressure
increase above PEEP
pressure in the bellows will
cause gas to bleed past the
exhaust valve (4).
A continuous flow from the
Inspiratory proportional
valve (1) ensures that any
fall in pressure is
compensated by driving the
bellows as required.
12
5
4
13
DESCRIPTION
A
Pneumatic Flow
Diagram
C
1817
5
8
14
9
12
6
16
13
15
11
7
1
2
10
4
3
B
0 - 80 cmH
2O
100 cmH
2O
0 - 90 cmH2O
241 kPa (35 psi)
3 to 7 bar
3.3 Pneumatic System
3.3.1 System Operation
Refer to the pneumatic system diagram on the
previous page.
A) Gas inlet manifold block
The AV-S Ventilator is designed to operate on a
310 - 689 kPa (45 -100 psi) drive gas supply
(oxygen or air - to customer’s requirement).
1. DISS Connector
The gas source is connected to the
DRIVE GAS SUPPLY 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 310 kPa
(45 psi).
2. Filter
The drive gas is filtered with a 40-micron
Input Gas Filter which protects the
pneumatic components from incoming
particulate matter.
3. The Low Supply Pressure Detector
The pressure switch is set at a
predetermined level to detect a loss or
reduction of the input gas source
pressure.
When the pressure falls below 235 kPa
(35 psi ± 1 psi), the LOW SUPPLY
PRESSURE indicator will be displayed
and the high priority audible alarm will
activate.
4. Input Pressure Regulator
Regulates the input drive gas to 260 kPa
± 21 kPa (38 psi ± 3 psi).
5. Cut-off Valve
The valve isolates the the gas supply :
a) when the ventilator is switched off
b) when a fault condition occurs.
6. Airway Pressure Sensor
Connected to expiratory limb of breathing
circuit.
DESCRIPTION
14
B) Pneumatic Control Manifold Block
7. Inspiratory Proportional Valve
8.
Flow Sensor
9. Drive Gas pressure Sensor
10. Low Pressure Regulator
11. Expiratory Proportional Valve
12. PEEP pressure sensor
13. Restrictor
The restrictor allows a flow of up to 2 L/min
(<2 L/min bleeding)
C) Exhaust Manifold Block
14. Check Valve
15. Diaphragm Valve
16. Pressure Relief valve
Set to 100 cmH
2O
17. Exhaust Port ( to AGSS)
18. Bellows drive gas outlet (to bellows
assembly)
3.4 Electrical System
Mains Supply
The mains supply inlet is designed for
connection to any mains voltage from 100 to
240 VAC and a frequency of 50 to 60 Hz,
without any adjustment.
The connector is a standard IEC type.
Back-up Battery
In the event of mains electrical failure, the backup battery cuts in automatically.
A fully charged battery will power the ventilator
for approximately 30 minutes.
See Appendix for battery care procedures.
DESCRIPTION
15
VmSET
Litres
3.6
VmMEAS
Litres
3.6
SET
BPM
6
Insp Time
Sec
2
PEEP
cmH2O
5
LIMIT
cmH2O
38
Spont
Mode
Pmean
cmH2O
10
Pmax
cmH2O
24
Standby
Freeze
Waveform
%O2 100
33 20
cm H2O
secs
AV-S
Touchscreen control
1
4
3
5
2
Gas Mixture
O2 + air
.
.
IO
o
o
DESCRIPTION
5. Navigator Wheel and Press Button
Turn the wheel to select a function or
parameter, or to alter the value of an
active parameter.
Press to confirm the setting.
3.5.1.2 Selecting Functions and
Parameters
The functions/parameters shown on the
screen can be activated as follows:
a) touch the screen at the appropriate tab
area.
b) rotate the navigator wheel and press it
when the indicator arrow is on the required
parameter tab
Note that parameters default to factory-set
values when the ventilator is switched on
and no further user selection is made.
3.5.1.3 User Adjustable Parameters
Variable parameters can be altered by
rotating the navigator wheel.
When the required value is displayed, press
the active tab or
the wheel to confirm the
setting.
3.5 Control Panel
3.5.1 Touchscreen and Navigator
Wheel / Push Button
3.5.1.1 Control Panel
1. On/Off control
Switch On:
Short internal test sequence
Switch Off:
5 second power down sequence with
audible tones
2. Status indicators for electrical power
(mains/battery supply)
Yellow indicator
- illuminated whenever power is
applied to the unit and internal battery
is being charged
Green indicator
- illuminates when the unit is switched
on, .
3. Menu switch
The menu function provides access to
user and service pages
4. Alarm mute switch
30 or 120 second Alarm silence,
depending on alarm status.
Note also that some alarms are not
mutable - see section 3.11.
16
Loading...