AV-S Ventilator: Draft Copy July 2005
AV-S Ventilator: Draft Copy July 2005
July 2005
No update will be given
AV-S Ventilator
Remote Display Module and Interface
for use with A200SP Absorber
Service Manual
Technical Support
Penlon Limited
Abingdon Science Park
Barton Lane
Abingdon
OX14 3PH
UK
1. Type of equipment
2. Product name
3. Serial number
4. Approximate date of purchase
5. Apparent fault
(i)
(ii)
3. DESCRIPTION
3.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.2 Ventilation Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4. SPECIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Ventilator .................................................. 34
Oxygen Monitor . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
(iii)
5. PRE-OPERATION PROCEDURES
5.1 Ventilator Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.1.1 Mounting the Ventilator ....................................... 39
5.1.2 Electrical Power Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.1.3 Ventilator Gas Supply .................................. 39
5.1.4 Breathing System Schematic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.1.5 Bellows Drive Gas ........................................... 43
5.1.6 Anaesthetic Gas Scavenging System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.1.7 Printer .................................................... 43
5.1.8 Breathing System ........................................... 43
5.1.9 Spirometer Connections ....................................... 44
5.1.10 Pressure Monitor Connections .................................. 46
5.1.11 Bellows Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6. SERVICE PROCEDURES
6.1 Service Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6.2 Control Unit Patient Block Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
7. SERVICE SCHEDULE
Service Schedule ..................................... 56
8. PARTS LISTS
Preventive Maintenance Kits .............................. 64
Assemblies 65
9. APPENDIX
1. Back-up Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
2. Menu System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3. Ventilator Spirometry System .......................... .... 82
4. Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Outside Surfaces ................................... .. 85
Bellows and Diaphragm Exhalation Valve . . . . . . . . . . . . . . . . . . . . . 86
Spirometer Sensors ................................... 86
Patient Connector Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Sterilisation ........................................... 87
Oxygen Monitor - Cleaning and Sterilisation . . . . . . . . . . . . . . . . . . 88
Oxygen Sensor Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
(iv)
This anaesthesia ventilator has been built to Statements in this manual preceded by the
conform with the specification and operating following words are of special significance:
procedures stated in this manual and/or
accompanying labels and notices when WARNING means there is a
checked, assembled, operated, maintained possibility of injury to the
and serviced in accordance with these user or others.
instructions.
CAUTION means there is a possibility
To ensure the safety of this device it must be of damage to the apparatus
checked and serviced to at least the or other property.
minimum standards laid out in this manual.
A defective, or suspected defective, product NOTE indicates points of
must not under any circumstances be used. particular interest for more
efficient and convenient
The user must accept responsibility for any
operation.
malfunction which results from non-
compliance with the servicing requirements
detailed in this manual. Always take particular notice of the
warnings, cautions and notes provided
Additionally, the user must accept throughout this manual.
responsibility for any malfunction which may
result from misuse of any kind or non-
compliance with other requirements detailed
in this manual.
The following WARNINGS and CAUTIONS 7. The driving gas is discharged through
must be read and understood before using the opening in the back of the ventilator
control unit.
this ventilator.
The discharged gas may contaminate
the environment, and should therefore
be extracted using a gas scavenging
WARNINGS system.
General Information
8. The bellows can only support
1. Personnel must make themselves approximately 1 kPa (10 cmH2O)
familiar with the contents of this differential positive pressure, above
manual and the machine’s function which it may be dislodged from the
before using the ventilator. mounting ring, resulting in dangerous
malfunction of the ventilator.
Do not connect a positive end
Before Using the Ventilator expiratory pressure (PEEP) valve or
2. Before the ventilator is used clinically other restrictive device to the exhaust
for the first time, verify that the hospital port on the bellows base.
engineering department has carried out This would increase the pressure inside
an earth continuity test. the bellows and the bellows could
detach from the base, causing serious
3. Excessive electronic noise caused by malfunction.
other poorly regulated devices, such as
an electrocautery unit, may adversely 9. Breathing System
interfere with the proper functioning of The breathing system which conveys
the ventilator. gases from the anaesthetic machine to
the patient, and disposes of expired
To avoid this problem, do not connect gases, must conform to the
the ventilator’s power cord into the requirements of ISO 8835-2.
same electrical wall outlet or adaptor Because breathing systems require
strip into which an electrocautery unit frequent cleaning and disinfection they
is connected. are not a permanent part of the
anaesthetic ventilator and therefore
4. If used with a mains extension cord, the cannot be directly under the control of
unit may be subject to electro-magnetic the anaesthetic ventilator manufacturer.
interference. However, we strongly recommend that
only breathing systems which have
5. The driving gas supply must be clean been approved and authorised by
and dry to prevent ventilator Penlon for use with AV-S should be
malfunction. employed.
11. The operation of each alarm function 17. In compliance with good anaesthesia
should be verified daily. practice, an alternative means of
ventilation must be available whenever
Periodically check the alarms at the ventilator is in use.
clinically suitable intervals. If the
audible alarm or the visual indicator of 18. It is recommended that the patient
any alarm function fails to activate oxygen concentration should be
during any alarm condition or fails to monitored continuously.
reset after the alarm has been cleared,
refer the unit to an authorised service 19. If the drive gas supply pressure drops
technician. below a nominal 241 kPa (35 psi), the
LOW DRIVE GAS SUPPLY alarm will
12. Before using the ventilator check that activate both audibly and visually.
all connections are correct, and verify Patient minute volume may be reduced
that there are no leaks. due to lowered flow rates
24. The High and Low Airway Pressure 31. Check that the cable between the
Alarms are important for patient care. control unit and remote display screen
It is important that the sensor is unit is connected before use.
properly located in the expiratory limb Always use a cable type recommended
of the circuit - refer to section 5.1.10. by the manufacturer.
Oxygen Monitor
NOTES
1. The O2 SENSOR FAULT alarm indicates
WARNINGS
that one of the following conditions has
1. We recommend calibration of the
occurred.
oxygen monitor every time the system
a) Internal electrical fault
is turned on, as a safety precaution.
b) Software/electronics fault
c) Oxygen sensor fault.
2. Do not attempt to open the fuel cell.
The sensor contains small quantities
2. The concentration read-out may, in
of :
certain conditions of excess pressure,
a) electrolyte, classified as a harmful
show a value above 100%.
irritant which is potentially hazardous,
To accommodate these conditions it is
and
possible to set the high alarm value up to
b) lead.
105% (see section 5).
Used or defective cells must be
3. To maintain maximum sensor life:
disposed of according to hospital,
i) always switch off the anaesthetic
local, state, and federal regulations.
machine after use, to ensure that the basal
flow ceases.
3. ALWAYS check the integrity of the
ii) disconnect the breathing circuit after
sensor assembly before use.
use.
4. Once exhausted, the sensor must be
4. The accuracy of flow and volume
disposed of according to hospital,
measurements may be reduced if the
local, state and federal regulations.
oxygen monitor is not in use.
5. The sensor measures oxygen partial
5. Fresh gas mixture compensation is disabled
pressure, and its output will rise and
fall due to pressure change. if the oxygen monitor is switched OFF.
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.
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.
AV-S Ventilator
Bellows unit
The bellows unit (1) is built into the A200SP 1
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.
5 8 9 10 11 12 13 14 15
6
3 2 1
7
4
NOTE
USB port is for use by Penlon-trained
engineers only.
All other data ports are read only.
For further information, please contact
Penlon Technical Support.
10
1. Inspiratory Phase
2. Beginning of
Expiratory Phase
1
The Inspiratory (1) and
Expiratory (3) proportional
valves close and the exhaust
valve (4) opens. Patient gas
4 returns to the bellows. As
3
the bellows rises, redundant
drive gas is pushed out
through the exhaust valve.
11
3. End of
Expiratory Phase
4
With the bellows at the top
of its housing fresh gas
continues to flow. To
prevent a high pressure
build up the exhalation
5 diaphragm (5) lifts and
allows gas to exit through
the exhaust valve (4).
4. PEEP
Positive End
Expiratory
1 Pressure
(user selectable)
4
During PEEP the Exhalation
Proportional valve (3)
applies PEEP pressure plus
3
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
A Pneumatic Flow
Diagram
1 3 to 7 bar
2
3 241 kPa (35 psi)
5 6
0 - 80 cmH2O
B 7 8 14
C
10 12
11 15
0 - 90 cmH2O
13
16
100 cmH2O
17 18
13
5. Cut-off Valve
The valve isolates the the gas supply :
a) when the ventilator is switched off
b) when a fault condition occurs.
14
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 back-
up battery cuts in automatically.
A fully charged battery will power the ventilator
for approximately 30 minutes.
15
2
AV-S
cm H2O Gas Mixture 1
IO
O2 + air o
o . .
%O2 100
SMMV
33 20
4
Trigger
Freeze
cmH2O
Waveform
-1.0
Pmax Pmean
3
cmH2O cmH2O
24 10 5
Spont
secs Mode
3.6 3.6 6 2 5 38
Touchscreen control
I:E Ratio
1:6 1:5 1:4 1:3 1:2 1:1 1:0.3
1.6
1.5
1.4
1.3
1.2
1.1
1.0
Tidal
Volume 0.9
(litres) 0.8 X
(Vt) 0.7
0.6
0.5
0.4
0.3
0.2
0.1
0 10 20 30 40 50 60 70 80
Rate (bpm)
The ventilator is capable of operating at the volumes and rates below each I:E ratio curve.
Example
1. Select required volume (Vt) (e.g. 0.8 L)
2. Select rate (e.g. 10 bpm).
3. Select I:E ratio of 1:2.
The point X on the graph lies beneath the 1:2 ratio curve, and is therefore within the
ventilator’s capability.
17
WARNING
The AV-S automatically compensates for fresh
gas (spirometry On), fresh gas mixture
(spirometry and oxygen monitor On), and
altitude.
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
NOTE
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.
NOTE
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.
Altitude Compensation
Monitors ambient pressure
Adjusts delivered volume accordingly
18
19
20
Altitude Compensation
Monitors ambient pressure
Adjusts delivered volume accordingly
Sigh function:
When the ventilator is in Volume Cycle
mode the "sigh" option is available. When
selected, this option provides extra volume
for 1 to 4 breaths in 50 (frequency is user
selectable).
The extra volume will be 50% above the
tidal volume set by the user.
21
3.7.3.1 Parameters
The ventilator delivers a volume of gas to
achieve a set pressure at fixed breath
intervals.
The Patient is making no respiratory effort.
This is a common mode for the ventilation of
small paediatric patients.
22
3.7.4.1 Parameters
The ventilator monitors the following patient parameters:
Rate
I:E ratio
Pressure
Tidal volume
No mechanical ventilation
No Inspiratory Pause function
23
3.7.5.1 SIMV D
Synchronised Intermittent
Pmax
Mandatory Ventilation
Guarantees a minimum level of volume.
SIMV allows spontaneous breaths and a
set mandatory breath PEEP
0 cmH2O
SIMV - Spontaneously Breathing A A
Patient B B
SIMV - Selection
Select Standby PEEP
Select Menu 0 cmH2O
A A
Select Special Modes
B B
Select SIMV
24
C E
3.7.5.2 SMMV D
Synchronised Mandatory
Minute Ventilation Pmax
SMMV -
No breathing effort by Patient
D
If the patient makes no effort to breathe
C
during a cycle, a mandatory breath, at
the end of the trigger window, will still Pmax
be delivered at the preset volume and
rate
SMMV - Selection
Select Standby Mode PEEP
Select Menu 0 cmH2O
A A
Select Special Modes
B B
Select SMMV
3.7.5.3 PSV
Pressure Supported B
Ventilation
PSV assists each spontaneous breath to
achieve
a preset pressure, thus reducing the
effort required to breathe
Inspiratory flow (generated by the
patient’s spontaneous breath) results in PEEP
synchronised 0 cmH2O
A A
pressure support
C C
PSV is used to support
spontaneously breathing patients
ONLY
If the patient makes no attempt to PSV Pressure Supported Ventilation
A = Set Inspiratory Time
breathe, the ventilator will not provide B = Pressure Support Level
C = Spontaneous Breath results in a synchronised pressure supported breath
support and the apnoea alarm will be
activated
PSV - Selection
Select Standby Mode
Select Menu
Select Special Modes
Select PSV
NOTE
1. The trigger window is pre-set to
60% of the BPM cycle time.
2. The trigger pressure is PEEP
referenced.
3. If the Spirometry is disabled then
PSV is not available.
4. If the pressure limit and alarm are
activated the inspiratory phase is
terminated.
26
Selecting PEEP
Select by touching the screen tab PEEP, or using the
navigator wheel
The setting will flash.
27
To Access:
Press the menu switch on the front panel to
access the following functions and parameters
via drop-down menus:
EXIT MENUS
O2 MONITOR & SPIROMETRY
FRESH GAS COMPENSATION: ON
SPECIAL MODES Menu Switch
WAVEFORM
ALARM SETTINGS
GAS MIXTURE: O2+AIR
USER SETTINGS
SERVICE MENU
Turn the wheel
To Exit: to scroll through
Press the menu switch on the front panel, or, the menus.
select EXIT MENUS and press the wheel. Press to enter
sub-menu
NOTE
The menu window will not be displayed if:
A) Control parameters (VT MEAS, BPM, I:E, PEEP,
or LIMIT) are enabled but not confirmed.
B) A display window is active
To Operate:
1. Rotate the navigator wheel clockwise to
scroll through the menu options - the
cursor ( > ) aligns with each parameter in
turn.
2. Press the wheel to enter the required sub-
menu.
3. Rotate the navigator wheel to change any
displayed values, and press to confirm.
4. To exit the menu display:
A) Press the menu switch on the front
panel .
B) Scroll to EXIT MENUS
and press the navigator wheel.
NOTE
A) If confirmation does not take place within 8
seconds, the parameter reverts to its previous
value.
B) If another parameter is selected using the
touchscreen, the menu is de-selected.
C) While any menu is selected:
- the alarms are active,
- the ventilator can be switched off.
28
3.9 Spirometry
Second waveform
A second waveform can be displayed by using
menu control or touch waveform on screen.
Display Functions
Y axis
a) Scale adjusts as Plimit is changed
(-20 to 40, 60, 80 cmH2O)
b) In Vol. v Time mode as Vt is changed
(0 to 0.5L, 1.0 L, 2.0 L)
X axis
a) Scale adjusts as Rate is changed
0 to 15sec, 5 sec, 3sec
b) In Vol. v Pres. mode as Plimit is changed
(-20 to 40, 60, 80 cmH2O)
29
Low Bellows Drive Gas Pressure High Fails to reach target level 30 s Automatic
High Bellows Drive Gas Pressure High Exceeds calculated target level 30 s
Automatic
High Airway Pressure High Pressure reaches set limit (10 to 80 cmH2O adjustable) 30 s User / Default
Low Airway Pressure High Breathing system pressure fails to reach minimum level 120 s Default
Negative Airway Pressure High Breathing system pressure exceeds 10 cmH2O 120 s Automatic
Low Tidal Volume High a) Measured Vt less than 50% of volume set 120 s User / Default
b) Spirometer disconnected
30
Low Minute Volume High Calculated volume lower than 50% of volume set 120 s User / Default
Apnoea High In Spontaneous mode, no breath detected within 15 seconds 120 s Auto
High Tidal Volume High Measured value exceeds 150% of set value 120 s User / Default
High Minute Volume High Calculated value exceeds 150% of set value 120 s User / Default
High O2 Concentration High Measured O2 % exceeds set value 120 s User / Default
Low O2 Concentration High Measured O2 % lower than set value 120 s User / Default
O2 Sensor low output Low Sensor life exhausted zero Auto
O2 sensor fault High Sensor disconnected 120 s Auto
Battery Power Fail Medium Battery disconnected, or missing, or totally discharged 120 s
Low Battery Low Battery voltage has dropped below 11.2 v zero
Absorber cable fault (A100SP) Medium Disconnection or short circuit 120 s Auto
Printer not available Low Printer disconnected, or has no power, or has no paper zero
Priority identification:
High Priority: 5 ascending tones - repeated Medium Priority: 3 ascending tones - repeated Low Priority: Single Tone - repeated
DESCRIPTION - O2 Monitor
Bacterial Filter
Use a breathing system bacterial filter in the
expiratory limb of the breathing circuit to protect the
oxygen sensor (see section 5 in the AV900 or AV-S
user manual).
CAUTION
Replacement/Disposal - always follow the instructions
supplied with the filter, and always replace at the
recommended interval.
1
3.12.2 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 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 1500 000 O2 percent hours at 20oC
(minimum one year in most normal applications).
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.
31
O2 Monitor sub-menu
ON/OFF
Turn the navigator wheel to switch between
O2 Monitor & Spiro
ON and OFF.
Press to confirm.
ESCAPE FROM MENU
Scroll to EXIT MENUS and press the wheel
> O2 MONITOR: on
to exit.
CALIBRATION: 100%
NOTE
HIGH ALARM SET: 105
The oxygen monitor automatically switches ON LOW ALARM SET: 18
and defaults to the previous values for high and SPIROMETER: on
low alarm settings when the ventilator is SPIRO CALIBRATION: 0 L/min
switched on.
Fresh gas mixture compensation is disabled if the
O2 monitor is switched OFF.
32
Oxygen Concentration
IO
The display provides a direct readout of
measured oxygen concentrations in the range
o
o . .
0-100%. %O2 100
33 20
Low Alarm Set - limited within 18-99%
The oxygen percentage, set by the user, at
which the low alarm will be activated.
Measured O2 Low Alarm Set
To set the low oxygen alarm, see section 5.3.4.
concentration Value
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 5.3.4.
3.12.5 Display
4.3 Physical
Size (mm)
- control unit only 290 wide x 300 deep x 185 high
- with adult bellows 290 wide x 300 deep x 385 high
Screen Size 210 mm (8.4") TFT
Weight - control unit only 7.6 kg
- with adult bellows 9 kg
Bellows
Adult (Latex free): 20 ml - 1600 ml
Paediatric : 20 - 350 ml
(Note - latex free paediatric available as option)
4.4 Alarms
Alarm Mute 30 or 120 seconds (see 3.11)
Low Drive Gas Pressure Less than 235 kPa (35 psi)
High Continuous Airway Pressure Above 30 cmH2O at start of cycle
Low Pressure 4 - 14 cmH2O PEEP referenced
Low Tidal Volume 50% of Volume set (Spirometry)
Incorrect Rate or Ratio
Mains Failure 30 minutes (nominal) Battery Backup
Low Battery 5 minutes Use
Ventilator Inoperative Internal or Battery Failure
Alarms - User Set
Vt (Tidal)
Min 0 - 1600 ml
Max 20 - 1600 ml
Vm (Minute)
Min 0 - 10 L
Max 0 - 30 L
34
4.5 Functional
Tidal Volume
Adult bellows 20 to 1600 ml (±10%)
Paediatric bellows 20 to 350 ml (±10%)
At ambient temperature of 20oC (+/-10%) and ambient atmosphere of 101.3 kPa (+/-10%).
Minute Volume 0 to 30 L
Rate 4 - 100 bpm
I:E Ratio 1:0.3 - 1:8
Pressure Limit 10 - 80 cmH2O
Fresh Gas Compensation Automatic Tidal Volume adjustment
Modes Off
Standby
Volume Cycle
Pressure Controlled
Spontaneous (includes advanced breathing modes)
Spirometry - Resolution ±1 ml
NOTE
The ventilator is designed for use with Spirometry ON.
Accuracy of delivered volumes with Spirometry OFF may vary from the figures given above.
35
4.8 Bacterial Filter None (see section 5.1.4, use a bacterial filter in
the breathing system to protect components
that are not autoclavable, e.g. oxygen sensor)
36
Accuracy and Linearity: ±2% of full scale (at constant temperature and pressure)
Response Time: 90% of final value in approx. 10 seconds (air to
100% O2)
Sensor
Type: Galvanic fuel cell sensor (0-100%)
Life: 1500000 O2% hours
(One year minimum in typical applications)
Interference Gases and Vapours (in 30% Oxygen, 70% Nitrous Oxide)
37
Humidity Effects
Sensor output is relatively unaffected by prolonged operation in either high or very low relative
humidity.
If the sensor shows signs of being affected by condensation, dry the sensor with soft tissue.
CAUTION DO NOT use heat to dry the sensor.
Temperature Effects
The sensor has a built-in temperature compensation circuit, and is relatively unaffected by
temperature changes within the operating temperature range given above.
Pressure Effects
The sensor measures O2 partial pressure, and its output will rise and fall due to pressure change
(e.g. changes in barometric pressure, or breathing system pressure).
An increase in pressure of 10% at the sensor inlet will produce a 10% increase in sensor output.
38
39
3 25 31
23
2 26
24
20 19 30
18
12
4 1
11 10
21
16 27 13
14
28 5 22
26
29
15 17 12
6
9
7
8
Note
1. AV-S has spirometry and oxygen monitor.
2. Interface cabling is shown for Prima SP2
On/Off switch and A200SP Bag/Vent
switch.
40
1. Bellows
2. Ventilator Control Unit
3. Outlets to Anaesthetic Gas Scavenging System (AGSS)
4. Bacterial Filter
5. Absorber valve block
6. Heat and moisture exchanger
7. Patient
8. CGO Block on anaesthetic machine (Fresh Gas Supply)
9. Auxiliary Outlet on anaesthetic machine (Drive Gas Supply)
10. Flow sensor - expiratory
11. Flow sensor - inspiratory
12 Connectors - sensor - pressure monitor
13. Expiratory Valve - Absorber
14. Inspiratory Valve - Absorber
15. Inlet - from Ventilator Bellows
16. Connector - Reservoir Bag
17. Inlet - Absorber - Fresh Gas Supply
18. Drive Gas Inlet - Ventilator
19. Drive gas Outlet - ventilator control unit to bellows
20. Outlet - Exhaust Valve
21. Inlet - Bellows Drive Gas
22. Outlet - to breathing system
23. Input socket - Oxygen monitor sensor
24. Input socket - Prima SP interface
(SP on/off switch)
25. Input socket:
(i) A200SP Absorber Bag/Vent control position
(ii) Spirometer sensor signal
26. Interface connections on Prima SP2 and A200SP
27. APL Valve
28. Outlet from APL Valve to AGSS
29. Oxygen sensor
30. Ventilator remote screen
31. Cable - control unit to screen
41
5 8 9 10 11 12 13 14 15
6
3 2 1
7
4
NOTE
USB port is for use by Penlon-trained
engineers only.
All other data ports are read only.
For further information, please contact
Penlon Technical Support.
42
5.1.8 Printer
Attach a printer to the printer port (2) if a
printed output of the ventilator function is
required.
43
5.1.10 Spirometer
5.1.10.1 Flow sensors fitted to an A200SP
Absorber mounted on a PrimaSP2
44
WARNING
The High and Low Airway Pressure Alarms are
important for patient care.
The connection point must be properly
located in the expiratory limb of the breathing
system.
46
7
4
6
2
47
Alarm System
WARNING
The operation of each alarm function should be verified
daily.
If the audible alarm or the visual display for 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.
Back-up Battery
WARNING
If the internal battery is fully discharged, the ventilator
will not function.
48
5.2.2 Function Test 10. Open the patient ‘Y’ -piece to ambient
pressure.
1. Set the AIRWAY PRESSURE LIMIT At the second cycle, the LOW
to 50 cmH2O. AIRWAY PRESSURE alarm should
be activated.
2. Connection for PRESSURE
TRANSDUCER: 11. Select STANDBY mode
Check that the port on the rear of the Before using the ventilator clinically,
control unit is correctly connected to check that all connections are correct,
the port on the rear of the absorber and verify that there are no leaks.
assembly (see section 5.1.10).
NOTE
3. Connect a 2-litre breathing bag to the If there is any malfunction, the ventilator must
patient connection as a test lung. NOT be used.
If the problem cannot be rectified, the ventilator
must be checked by a Penlon trained engineer.
4. Adult bellows only:
Set the tidal VOLUME to 600 ml;
RATE to 10 bpm, and I:E RATIO to
1:2.0.
49
Alarms
1. Select STANDBY MODE.
NOTE
If there is any malfunction, the ventilator must
NOT be used.
If the problem cannot be rectified, the ventilator
must be checked by a Penlon trained engineer.
Bellows
Check the condition of the bellows and
exhalation diaphragm valve - see section
6.2.2.
50
5.3.1 Installation
Fit the probe (A) to the A200SP absorber.
Connect the cable to the input socket (B) on
the back of the AV-S ventilator control unit
WARNING
The sensor contains a small quantity of
electrolyte, classified as a harmful irritant
which is potentially hazardous.
Do not attempt to open a cell.
ALWAYS check the integrity of the sensor
assembly before use.
Once exhausted, the sensor must be A
disposed of according to hospital, local, state
and federal regulations. B
NOTE
To maintain maximum sensor life:
i) always disconnect the breathing circuit after
use.
ii) Switch off the anaesthetic machine to cut-off
the basal flow through the system.
Bacterial Filter
Use a breathing system bacterial filter in the
expiratory limb of the breathing circuit to
protect the oxygen sensor (see section
5.1.8).
CAUTION
Replacement/Disposal - always follow the
instructions supplied with the filter, and always
replace at the recommended interval.
5.3.2 Calibration
The new unit must be calibrated before
clinical use.
Thereafter, as a safety precaution, we
recommend calibration of the unit every
time the system is switched on.
51
8. Scroll to CALIBRATION.
If the menu shows 21% (which indicates
calibration using air), press the navigator
wheel / button (6) to switch to 100%
(calibration using oxygen).
52
53
Every day:
Pre-use function check
Every week:
Check the condition of the diaphragm valve,
and clean as required.
Every 6 months:
Inspection and Function Check.
Remove patient block assembly and clean.
Check condition of bellows.
Every 12 months:
Repeat six month procedure, plus:
Replace components, including O-seals,
drive gas inlet filter, exhaust diaphragm,
one way valve.
Preventive maintenance kit available.
Every 2 years:
Repeat 12 month service, plus:
Replace battery.
Every 2 years:
Repeat 12 month service, plus:
Replace PCB battery and bellows
diaphragm valve.
54
Refitting
5. Position the patient block and push
fully into the control unit, ensuring
that the metal tubes (4) are engaged 4
in their unions.
6. Fit the securing knobs (3).
7. Function test the ventilator.
55
2.4 Default selection screen appears and automatically defaults to adult mode after
approximately eight seconds.
2.5 Mains indicator illuminates green
2.6 Check screen is undamaged, display is clear and that the touch sensitive screen
functions are operating correctly.
4.2 Select 'Clock Menu' check date and time are correct.
Year = 2005 - 2099
Month = 1-12 (Jan - Dec)
Date = 1- 31
DOW = 1-7 =(Day of week, Mon - Sun)
Hour = 1-23
Minute = 1-59
56
5.1 Select 'Service Menu' - 'Engineer Menu' - 'Diagnosis Menu'- 'Display Error Log'
5.2 Check and investigate errors. Up to 30 Error Codes can be stored. Format is:
Date - Time - Fault
Example: 08/05/01 - 09:12:40 - On/Off Valve
6.3 Discard old bellows and replace with new. (every 12 months)
6.8 Replace large orange o-ring from bellows canister (not absorbent canister)
(every 12 months)
Replace small o-ring from diaphragm valve. (every 12 months)
Apply oxygen approved grease
6.11 With hand occlude the Inspiratory connector of the absorber and inflate bellows
assembly using flush button until bellows is at top of housing.
With no flow from anaesthesia machine bellows should not drop.
6.12 Move hand from Inspiratory connector and occlude drive gas hose at rear of absorber.
Bellows will fall momentarily but then should stop falling.
Failure of either 6.11 or 6.12 indicates a bellows leak, diaphragm valve leak, drive gas
hose leak or canister leak.
57
7.5 Remove the 5mm hexagonal fitting at the rear of the control unit.
Replace Gas Supply Filter. (every 12 months)
7.7 With patient valve still removed, connect ventilator to power supply.
Reconnect gas supply.
Switch on the unit.
In 'Standby Mode', set inspiratory flow of 5l/min using front panel settings: 500, 5, 1:1,
OFF, 38.
Switch ventilator to 'Volume Mode'
7.10 During expiratory phase ensure that there is no gas flow from the Drive Gas connector.
If necessary carry out Drive Gas Valve Offset calibration.
8.1 From 'Diagnosis Menu' check supply voltages and battery current as follows, with the
mains lead connected:
'V IN' = 1096 mV±10% (mV x 13 = input voltage)
'V SUPP' = 1060 mV±10% (mV x 13 = input voltage)
'I BATT' 0 - 450 mV (mV x 1.333 = mA)
8.2 Check all electrical connections and components for security. (every 12 months)
58
9.3 Connect the pressure tube to 'Patient Pressure' connection on the rear panel of the
control module to the Pressure Sensing port on the rear of the absorber.
9.4 Connect the cable from the 'Interface' connector on the rear panel of the control
module and to the Spirometer connection on the rear of the absorber and the rear of
the Prima SP anaesthesia.
9.5 Attach the 'Fresh Gas Supply' hose from the absorber to the CGO of the PrimaSP
9.6 Connect a patient breathing circuit to the CO2 absorber and attach the patient
connector to a test lung.
9.7 Connect the Gas Scavenging System to the "Exhaust' connector on the rear of the
vent. (If no scavenge system is attached to the rear of the ventilator, a continuous
bleed during the inspiratory phase will be audible)
10.2 Power Off the Anaesthesia machine. Ventilator should switch 'OFF'
10.4 Default selection screen appears and automatically defaults to adult mode after
approximately eight seconds
10.5 Note: standby mode is highlighted white in the bottom right of screen.
10.6 Set incorrect rate, i.e. increase Vt, and/or Rate controls.
Check 'Incorrect Rate Or Ratio' displayed on screen and 3 alarm tones sound. Do not
confirm settings, wait for default values to return.
11.2 Check Vent O2 sensor is inserted into the absorber O2 sampling point.
11.8 On ventilator, adjust high and low O2 alarms and check alarms trigger when values
59
12.2 Disconnect fresh gas hose from anaesthesia machine Common Gas Outlet. Switch
Bag/Vent switch to 'Bag' and remove bag from bag arm.
Remove test lung from patient connector if fitted, or remove patient circuit. Ensure
scavenging circuit is not connected.
12.4 From menu select 'Oxygen Monitor & Spirometry'- 'Spiro Calibration'.
12.14 Reconnect fresh gas hose, patient circuit and manual bag and re-set bag/vent switch
to 'Vent' position.
13.5 Press 'Mute' verify audible alarm is muted for 120 seconds.
(Note, alarm mute countdown is displayed at bottom right of touch screen.)
13.6 Switch absorber to bag mode, close APL valve. Inflate bag with O2 flush and repeat
tests 3 - 5 above using re-breathing bag.
60
NB: If absorber switch is not enabled in service menu message will read 'Absorber in
vent mode?' Press 'SMMV' once again.
NB: If absorber switch is not enabled in service menu message will read 'Absorber in
vent mode?'
Press 'PSV' once again.
13.14 Operate Test Lung (by hand) and check that occasional ventilator assistance is given
with a pressure of 10 cmH2O.
13.15 Stop operation of test lung and ensure pressure reading falls to zero and after 30 sec
delay check 'Low Tidal Volume' alarm triggered and 'Vt meas.' shows '= = ='.
14.2 Set 'Vt' to 600 ml, 'BPM' to 10, 'I:E' to 1:2 and 'Pressure Limit' to 80.
14.4 Press 'Insp Pause' check 25% pause during the inspiratory phase.
14.5 Check measured display indicates 600 ml +/- 50ml on 'Vt Meas'
14.7 The bellows still delivers 600 ml +/- 50 ml but the measured volume will reduce to
approximately 500 ml with a standard test lung
61
14.14 Check the ventilator is operating smoothly, test lung is inflating, and system pressure is
displayed on both vent and absorber manometer.
15.1 Set ventilator to default settings and ventilate test lung in 'Volume' mode.
15.4 Volume cycle vent, adjust Vt Set to achieve a peak airway pressure of greater than 30
cm H2O of water.
62
16.4 Check waveform holds the airway pressure values. (Level display)
A falling display indicates a leak either in the driving circuit, the patient circuit or the
absorber system.
63
64
5000492
Arm Assembly
65
66
67
5 019049 M3 X 10 LG Pan HD 3
7 5000489 Chassis Assembly 1
8 5000499 Tray Assembly (Remote) 1
68
69
8 103996 Battery 1
9 104715 LEC Mains Connector / Filter 1
10 2220-099 LEC Mains Plug Retainer Assembly 1
70
72
75
1 300580 Diaphragm 1
2 300581 One-way valve 1
3 300583 Inline Relief Valve 1
4 5000478 Check Valve Cap 1
5 300593 Taper Adaptor 1
6 300594 Tapered Conn 1
7 5000448 Spring Guide 1
8 5000450 Valve Body 1
9 5000451 Seat Insert 1
10 5000452 Drive Gas Block 1
11 5000453 Valve Base 1
76
77
APPENDIX 1
Care of Back-up Battery
CAUTION
Damage may occur if the battery is allowed to remain in a discharged
state.
Never discharge the battery to below 10.2 volts.
Storage Recharge
temperature period
Note
Removal/replacement of battery must only be undertaken by a trained
technician
78
APPENDIX 2
On-screen Menus
NOTE:
79
Waveform
Alarm settings
ALARM MENU
ESCAPE FROM MENU
ALARM MODE : default default / user (Toggle option)
HIGH TIDAL VOLUME: off off / on (Toggle option)
VM MIN: 0.3 L 0.0 - 7.4 (Integer)
VM MAX: 0.9 L 0.1 - 7.5 (Integer)
VT MIN: 300 mL 10 - 1600 (Integer)
VT MAX: 900 mL 20 - 2400 (Integer)
APNOEA ALARM LIMIT: 0.3 cmH2O 0.3 - 3.5 (Integer)
ALARM VOLUME: 50% 50 - 100% (Integer)
Select settings
User Settings ESCAPE FROM MENU
USER1: CCT1
ESCAPE FROM MENU USER2: CCT2
SELECT SETTINGS USER3: CCT3
SAVE SETTINGS USER4: CCT4
BACK LIGHT LEVEL: 50% USER5: CCT5
VOLUME TYPE: tidal ADULT DEFAULT
PAEDIATRIC DEFAULT
Save settings
ESCAPE FROM MENU
USER1: CCT1 CONFIRM: CCT1
USER2: CCT2 CONFIRM: CCT2
USER3: CCT3 CONFIRM: CCT3
USER4: CCT4 CONFIRM: CCT4
USER5: CCT5 CONFIRM: CCT5
Backlight level
0 - 100% (integer)
Volume type
tidal/minute (toggle)
Service
See next page
80
Clock
ESCAPE FROM MENU Clock pick list (integer)
YEAR: 2005 2005 - 2099 (integer)
MONTH: 3 1 - 12 (integer)
DATE: 16 1 -31 (integer)
DOW: 3 1 - 7 (1 = Monday) (integer)
HOUR: 9 0 - 23 (integer)
MINUTE: 57 0 - 59 (integer)
UPDATE CLOCK
DAYLIGHT SAVING: off off / on (toggle option)
Upgrade
ESCAPE FROM MENU
I/O HARDWARE: 2
I/O FIRMWARE: v0.47 [Build 68]
MAIN FIRMWARE: v0.92 [Build 32]
REGISTRATION KEY: unknown
UPGRADE FIRMWARE: unavailable
ADD NEW FEATURE: unavailable
History Display
ESCAPE FROM MENU
MANUFACTURER DATE : 03/03/05
TOTAL HOURS RUN: 100
LAST SERVICE DATE: 13/08/04
HOURS SINCE SERVICE : 100
DRIVE VALVE CYCLES: 1253
PATIENT VALVE CYCLES: 822
CUTOFF VALVE CYCLES: 72
*NOTE
Service PIN
Engineer Menu
81
82
83
5
4.5
4
3.5
Resistance 3
(cmH2O) 2.5
2
1.5
1
0.5
0
0 20 40 60 80 100 120 140
Flow
(L/min)
84
APPENDIX 4
Cleaning A
Outside surfaces and bellows housing
CAUTION
Care must be taken not to allow liquids to run into the control
unit; serious damage
may result.
Bellows
As with all elastomers, the bellows material deteriorates
with aging and should be inspected at least every six
months or after 1200 hours of use, whichever comes first.
The bellows must be replaced if it shows signs of aging.
85
Clean the seat, and the metal disk (E) attached to the
base of the diaphragm valve, thoroughly and remove all
Exhalation Diaphragm Valve
contamination from the surfaces of both components. Assembly
NOTE
If excessive contamination is discovered, check that a bacterial
filter is used in the expiratory limb of the breathing circuit (or an
HME at the patient tee-piece).
Refitting
Refit the diaphragm valve assembly to the bellows base
and reassemble the bellows assembly
If a paediatric bellows is fitted, press the adaptor (C) into
the ventilator bellows assembly base, then fit the bellows.
CAUTION
Always check for correct fitment of the bellows (see illustration),
and function test the ventilator before clinical use.
Spirometer Sensors
The sensors are built into the A200SP absorber, and
cleaning and sterilisation can only be carried out when the
absorber assembly is removed for cleaning.
For further information please refer to the user
instructions supplied with the A200SP.
86
Sterilisation
CAUTION
To prevent possible damage to components, peak sterilisation
temperatures must not exceed :
54oC (130oF) for gas (ethylene oxide) or,
134oC (275oF) for steam autoclave.
Low temperature autoclave is 121oC
ITEM METHOD
NOTE
1. Liquid method indicates the use of a high level
disinfectant.
2. Examples of suitable high level disinfection liquid agents
are: Nu-Cidex, Sporicidin, and Sonacide.
3. The exhalation diaphragm valve must be removed,
cleaned and sterilised separately.
87
Bacterial Filter
Use a breathing system bacterial filter in the expiratory limb of the
breathing circuit to protect the oxygen sensor (see section 5.1.8).
CAUTION 1
Replacement/Disposal - always follow the instructions supplied with the
filter, and always replace at the recommended interval.
88
Manufactured by:
Penlon Limited
Abingdon Science Park
Barton Lane
Abingdon
OX14 3PH
UK
Technical Support
Tel: 44 (0) 1235 547076
Fax: 44 (0) 1235 547062
E-mail: [email protected]
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Tel: +44 1235 547001
Fax: +44 1235 547021
E-mail: [email protected]
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Tel: 01235 547036
Fax: 01235 547023
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