DRE AV-S User manual
AV-S Ventilator
User Manual
This manual contains information for software upgrade v.1.87.01
DATASHEET
USER
AV-S Ventilator User Manual
Software Version 1.87.01
Addendum to the User Manual
Keep this Datasheet with the User Instruction Manual for AV-S at all times
Introduction
AVS software V. 1.87.01 introduces a new
user interface. However, if you are familiar
with the AV-S, please note that the basic
operation and calibration procedures remain
as per v.1.86.
Modifications to the User Interface
Setting up the Ventilator for use
1. Introduction Screen
1.1 Start-up
At start-up, the introduction screen
allows the user to select one of three
default settings:
SITE DEFAULTS
ADULT DEFAULTS
PEDIATRIC DEFAULTS
NOTE
a) The user must select one of the
above default groups before the
ventilator will switch to standby in that
default mode
b) SITE DEFAULT is editable in
standby mode (see section 1.2, below)
c) Settings can be saved via the
service menu to create a new site
default
1.2 Default Settings
1.2.1 Selection
The user can select ADULT, or
PEDIATRIC, or SITE, and view the
default parameter settings.
The options will remain, even after the
ventilator is turned off.
1.2.2 Site Default Settings
Adjust the parameter values from within
the Service menu (SITE DEFAULTS)
Press to confirm the new settings for
site defaults.
1.3 Calibrate Touchscreen
The introduction screen allows the
user to calibrate the screen
2. Parameter Display Identification
2.1 Active Parameters
Active parameters that can be set for use
in the current mode are displayed as:
White Text on Blue
2.2 Inactive Parameters
Inactive parameters that can be set for
any non-current mode are displayed as:
White Text on Blue Label
White values on Black
2.3 Measured Parameters
Yellow values on Black
2.4 T+PS INIT (target and pressure support
initial value)
The initial pressure value can be changed
so that when entering either PRESSURE
or PSV modes the TARGET value or
PSUPP value are pre-selected.
NOTE
Changing either of these limits in their
active modes will maintain the value when
changing between PSV, PRESSURE, and
STANDBY modes.
3. Gas Mixture
The Gas Mixture window is an active
touch-selectable area (in any mode), with
a drop down menu.
Gas Mixture is also available through the
menu structure.
Selection of the required mixture is in the
normal way with the scroll wheel.
Using the Ventilator - description of
modes and functions
4. Modes
4.1 Access to Support Modes
Access is available in Standby mode
(depending on the support mode options
on the ventilator).
Support Mode
a) PSV
b) SIMV
c) SMMV
d) SIGH ENABLE
SIGH TO BREATH RATIO
e) INSP PAUSE
INSP PAUSE %
WARNING
Modes a, b, and c are only available
when Spirometry is enabled.
2
4.2 Standby Mode
a) Standby mode at ventilator start-up:
The last used Volume mode settings will
be displayed
b) Standby mode selected while the
ventilator is in use:
The screen will display the previous
ventilation mode, highlighted in yellow,
within the relevant box. The last used
parameters will also be displayed.
4.3 Spontaneous Mode
a) Spontaneous mode at ventilator start-
up:
Default values will be displayed in white
on a black background if the ventilator
has just been powered ON.
b) Spontaneous mode selected while the
ventilator is in use:
The last used ventilation mode
(underlined) will be displayed, with the
last used set values in white on a black
background
4.4 Sigh
Sigh is settable from 1:n, where n has a
range of 10 to 100.
The Sigh menu can also be accessed by
touching the icon area of the screen.
NOTE
1:10 is one sigh to ten normal breaths.
4.5 Inspiratory Pause
Inspiratory pause can be varied in the
menu from 0 - 60%.
The inspiratory pause menu can also be
accessed by touching the icon area of
the screen.
WARNING
This can affect the maximum Tidal
Volume.
3
5. Apnoea Alarm Mute - Spontaneous
mode only
NOTE
The occurrence of another alarm event
will override this feature
In spontaneous mode the mute button
acts both to silence an existing apnoea
alarm and inhibit new apnoea alarms for
a given period (provided that no other
alarm events are present) .
This time period is selectable (choose
from 15, 30, 60, 120, or 180 seconds)
through the alarm settings menu, or
accessed by touching the alarm area of
the screen.
To adjust the default setting, use the SITE
DEFAULT menu option.
6. Touchscreen Access to Mode
Configuration Options
Touch the screen in the area containing
the green icons to access mode
configuration options (including INSP
PAUSE, SIGH, and APNOEA ALARM
mute/inhibit).
7. Waveform Pause and Print
Waveform pause and print icons are
located to the left hand side of the
waveform displays.
Ensure that a compatible printer is
connected, and switched On (see section
5.1.8).
To print the waveform information, press
the pause icon. The print icon will be
displayed. Press the icon to print.
Press the pause icon to unfreeze the
waveform.
8. Waveform Freeze Loop
The FREEZE LOOP icon is located at the
left hand side of the top waveform.
9. Leak Test
a) Select LEAK TEST through the Menu
in Standby Mode.
b) With the bag/vent switch in VENT
position, this checks for a leak using an
occluded breathing system
The leak test procedure is given in
section 5.1.12 in the user manual.
4
Modifications to Operational Envelope
(sections 4.5 and 4.6 in user manual)
Flow Range: 2 – 70 Litres per min.
Volume Range: 20 ml – 1.6 Litres (tidal)
2 – 50 Litres per min (minute vol.)
Rate 4 – 100 bpm
I:E Ratio 1:0.2 – 1:8.0 (normal)
1:2.0 – 1:8.0 (effective in support modes)
Inspiratory Time 0.3 – 10 seconds (normal)
0.3 – 5 seconds (effective in support modes)
ExpiratoryTime 0.3 – 10 seconds
(effective dependent on Inspiratory time)
Additional information on Sigh and Inspiratory Pause
(section 3.7.2.4)
Inspiratory Pause
Inspiratory Pause has a range of 0 to 60% of the inspiratory time.
Sigh
This function must be enabled in the mode menu but is only
operational in volume ventilation.
The sigh ratio is 1 to n (1:n) with n giving a range of 10 – 100 breaths
between sighs.
5
EXIT MENUS
O2 MONITOR & SPIROMETRY
LEAK TEST
FRESH GAS COMPENSATION:ON
MODES
WAVEFORM
ALARM SETTINGS
GAS MIXTURE: O2+AIR
SERVICE MENU
O2 Monitor & Spirometry
ESCAPE FROM MENU
O2 MONITOR: on
CALIBRATION: 100%
HIGH ALARM SET: 105
LOW ALARM SET: 18
SPIROMETER: on
SPIRO CALIBRATION: 0 L/min
off / on (Toggle option
21 / 100% (Toggle option)
19 -105 (Integer)
18 - 99 (Integer)
off / on (Toggle option)
0 L/min / 10 L/min (Toggle option)
off/on (Toggle option)
Fresh Gas Compensation
ON / OFF
Special Modes
See next page
Waveform
ESCAPE FROM MENU
SECOND WAVEFORM: off
Second waveform pick list
off
vol. vs time
vol. vs press.
Alarm settings
ALARM MENU
ESCAPE FROM MENU
ALARM MODE : default
HIGH TIDAL VOLUME: off
VM MIN: 3 L
VM MAX: 9 L
VT MIN: 300 mL
VT MAX: 900 mL
APNOEA ALARM LIMIT: 15 secs
ALARM VOLUME: 50%
default / user (Toggle option)
off / on (Toggle option)
0.0 - 7.4 (Integer)
0.1 - 7.5 (Integer)
10 - 1600 (Integer)
20 - 2400 (Integer)
0.3 - 3.5 (Integer)
50 - 100% (Integer)
Gas mixture: O2+Air
O2+AIR
O2+N2O
Leak Test
ESCAPE FROM MENU
<START/STOP LEAK TEST>
LEAK STATUS: unknown
LEAK LEVEL: 0 mL/min
BSYS COMP 7.0 mL/cmH2O
Service
See page 62
Menu Structure
Main Menu
6
The SPECIAL MODES menu is context sensitive, with the contents
dependent on current mode.
In STANDBY the SPECIAL MODES menu is:
ESCAPE FROM MENU
SUPPORT MODE: SIMV, SMMV, PSV
(1)
VOLUME TYPE: Tidal
SIGH ENABLE:
(2)
SIGH TO BREATH RATIO:
INSP. PAUSE% : 0%
APPLY: SITE DEFAULT
In SPONT mode and VOLUME mode, and SIMV/ SMMV, the SPECIAL
MODES menu is:
ESCAPE FROM MENU
VOLUME TYPE: Tidal
SIGH ENABLE:
(2)
SIGH TO BREATH RATIO:
INSP. PAUSE% : 0%
In PRESSURE mode and PSV modes the SPECIAL MODES menu is:
ESCAPE FROM MENU
SIGH ENABLE:
(2)
SIGH TO BREATH RATIO:
INSP. PAUSE% : 0%
Notes
(1) Support mode depends on configuration options.
The SUPPORT MODE option will be missing from the SPECIAL
MODE menu if:
a) Options are not enabled
b) ‘’SPIROMETRY: off’’ is displayed.
The support mode sub menu can include:
none / PSV / SIMV / SMMV
(2) The options here are: 0 - 60%
(3) The options here are:
on - off
1:10 to 1:100
Note
1:10 indicates 1 breath with sigh, then 10 breaths without sigh
(2) The TRIGGER values are L/min with SPIROMETRY enabled, or
cmH
2O when SPIROMETRY disabled.
Spirometry enabled Spirometry disabled
0.7 L/min 0.5 cmH
2O
0.8 L/min 0.6 cmH
2O
0.9 L/min 0.7 cmH
2O
1.0 L/min 0.8 cmH
2O
1.5 L/min 0.9 cmH
2O
2.0 L/min 1.0 cmH
2O
2.5 L/min 1.2 cmH
2O
3.0 L/min 1.5 cmH
2O
3.5 L/min 1.7 cmH
2O
4.0 L/min 2.0 cmH
2O
SPECIAL MODES MENU
ESCAPE FROM MENU
SUPPORT MODE: SIMV, SMMV, PSV
VOLUME TYPE: Tidal
SIGH ENABLE:
SIGH TO BREATH RATIO:
INSP. PAUSE% : 0%
APPLY: SITE DEFAULT
7
UPGRADE MENU
ESCAPE FROM MENU
I/O HARDWARE: 2
I/O FIRMWARE: vx.xx [Build xx]
MAIN FIRMWARE: vx.xx [Build xx]
REGISTRATION KEY: unknown
UPGRADE FIRMWARE: unavailable
ADD NEW FEATURE: unavailable
DISPLAY HISTORY
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
Service
ESCAPE FROM MENU
LANGUAGE: ENGLISH
PATIENT LOG MENU
SITE DEFAULTS
SERIAL MODE: none
ABSORBER SWITCH; ON
CLOCK MENU
UPGRADE MENU
AMBIENT PRESSURE: 988 mBar
DISPLAY HISTORY
*SERVICE PIN: 0
*ENGINEER MENU
CLOCK MENU
ESCAPE FROM MENU
YEAR: 2005
MONTH: 3
DATE: 16
HOUR: 9
MINUTE: 57
UPDATE CLOCK
DAYLIGHT SAVING: off
PATIENT LOG MENU
ESCAPE FROM MENU
PRINT PATIENT DATA
LOGGING: off
LOG STATUS: disabled
CLEAR LOG DATA
LOGGING WINDOW: 10 min
Clock pick list (integer)
2005 - 2099 (integer)
1 - 12 (integer)
1 -31 (integer)
0 - 23 (integer)
0 - 59 (integer)
off / on (toggle
option)
*NOTE
Sub-menus for Service PIN and
Engineer Menu are not accessible
by users.
SERVICE MENU
SITE DEFAULTS
ESCAPE FROM MENU
SAVE TO SITE
VIEW: SITE DEFAULTS
VOLUME TYPE : tidal
Vt SET: 550 ml
Vm SET: 5.5 Litres
T+PS INIT: 10 cmH2O
SET BPM : 10
I : E : 1:1.0
PEEP : OFF
LIMIT : 38 cmH2O
TRIGGER : 10 L/min
APNOEA ALARM LIMIT : 15 Sec
BACK LIGHT LEVEL : 50 %
Doc No. AVS 0408DS (U)
September 2008
DRE, Inc. 1800 Williamson Court Louisville, KY 40223 USA
Tel: (502) 244-4444
Fax: (502) 244-0369
Web: www.dremed.com
IMPORTANT
(i)
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 / two year / four year service -
inspection and function testing, and
component 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 DRE, Inc.
Technical Support
DRE, Inc.
1800 Williamson Court
Louisville, KY 40223
USA
Tel: (502) 244-4444
Fax: (502) 244-0369
Web: www.dremed.com
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
FOREWORD
(ii)
Parameter / Device Relevant Standard
Pressure Measuring ISO 8835-2
Pressure Limitation Device EN 60601-2-13:2006 - 51.101.1
Exhaled Volume Monitor EN 60601-2-13:2006 - 51.101.4
Breathing System Integrity Alarm System EN 60601-2-13:2006 - 51.101.5
Continuing Pressure Alarm EN 60601-2-13:2006 - 51.101.6
Oxygen Monitor ISO 7767
Carbon Dioxide Monitor ISO 9918
Breathing Circuit ISO 8835-2
Agent Monitor ISO 11196
Gas Scavenging ISO 8835-3
For information on installing and connection of any of these systems or devices, please refer to the relevant manufacturer’s instructions.
This manual has been produced to provide
authorized personnel with information on the
function, routine performance and
maintenance checks applicable to the AV-S
Anesthesia 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.
The Importance of
Patient Monitoring
WARNING
Anesthetic 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 anesthetist.
There can be considerable variation in the
effect of anesthetic drugs on individual
patients so that the setting and observation of
control levels on the anesthesia systems
does not in itself ensure total patient safety.
Anesthesia system monitors and patient
monitors are very desirable aids for the
anesthetist 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.
Before using any monitoring system or
device, the user must check that it conforms
to the relevant standard, as listed in the table
below.
CONTENTS
(iii)
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
3.4 Electrical System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 14
3.5 Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.5.1 Touchscreen Operation and Navigator wheel / push-button . . . . . . . . . . . . 15
3.5.2 User Adjustable Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.5.3 Operational capability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.5.4 Output Compensation Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.6 Interface with Integra AV-S and A200SP . . . . . . . . . . . . . . . . . . . . . . 20
3.7 Ventilation Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.7.1 Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.7.2 Volume Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.7.3 Pressure Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.7.4 Spontaneous Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.7.5 Advanced Spontaneous Breathing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.7.5.1 SIMV (Synchronised Intermittent Mandatory Ventilation) . . . . . . . . . . . . . 26
3.7.5.2 SMMV (Synchronised Mandatory Minute Ventilation) . . . . . . . . . . . . 27
3.7.5.3 PSV (Pressure Supported Ventilation) . . . . . . . . . . . . . . . . . . . . . . 28
3.7.5.4 PEEP ( Positive End Expiratory Pressure) . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.8 On-screen Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
3.9 Spirometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.10 Display Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.11 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
3.12 Oxygen Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
3.12.1 System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
3.12.2 The Oxygen Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
3.12.3 Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
3.12.4 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
3.12.5 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
3.12.6 Alarm Mute. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4. SPECIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Oxygen Monitor . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
CONTENTS
(iv)
5. PRE-OPERATION PROCEDURES
5.1 Ventilator Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.1.1 Mounting the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.1.2 Electrical Power Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.1.3 Ventilator Gas Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.1.4 Breathing System Schematic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.1.5 Bellows Drive Gas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
5.1.6 Anesthetic Gas Scavenging System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
5.1.7 Remote Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5.1.8 Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5.1.9 Breathing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5.1.10 Spirometer Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
5.1.11 Pressure Monitor Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.1.12 Leak Test / Compliance value Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.1.13 Bellows Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
5.2 Pre-use Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.2.1 Daily Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.2.1.1 Alarm System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.2.1.2 Ventilator Internal Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.2.1.3 Function Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.2.2 Weekly Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
5.3 Oxygen Monitor Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5.3.1 Installation . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5.3.2 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5.3.3 Sensor Low Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
5.3.4 Setting the High and Low O
6. MAINTENANCE
6.1 Service Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
6.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
6.2.1 Outside Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
6.2.2 Bellows Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
6.2.3 Spirometer Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
6.2.4 Oxygen Monitor Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
6.2.5 Patient Connector Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
6.3 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
6.4 Oxygen Monitor Sensor Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
7. APPENDIX
1. Back-up Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
2. Menu System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
3. Ventilator Spirometry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
4. Disposal after use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
5. Approved Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
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
This anesthesia 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 DRE, Inc.
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.
USA and Canada:
Federal Law restricts the sale and use of this
device to, or on the order of, a licensed
practitioner.
1. WARNINGS AND CAUTIONS
2
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 AV-S ventilator is used
clinically for the first time a Calibration
Check and Output Check must be
successfully completed.
Calibration and output checks must be
carried out by a DRE-trained
technician, following the procedure in
Appendix 6 in the AV-S Service Manual.
3. Before the ventilator is used clinically
for the first time, verify that the hospital
engineering department has carried out
an earth continuity test.
If the integrity of the protective
conductor is in doubt, the ventilator
must not be used.
Before the ventilator is used clinically
for the first time, the commissioning
engineer must confirm that the
air/oxygen selection is set correctly for
the drive 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.
8. 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.
9. The bellows can only support
approximately 1 kPa (10 cmH
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.
2O)
4. 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.
5. If used with a mains extension cord, the
unit may be subject to electro-magnetic
interference.
6. The driving gas supply must be clean
and dry to prevent ventilator
malfunction.
7. This ventilator is designed to be driven
by oxygen or medical air only. The
drive gas is set during manufacture
and the ventilator is calibrated for that
gas.
10. Breathing System
The breathing system which conveys
gases from the anesthetic 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
anesthetic ventilator and therefore
cannot be directly under the control of
the anesthetic ventilator manufacturer.
However, we strongly recommend that
only breathing systems which have
been approved and authorized 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.
WARNINGS AND CAUTIONS
3
11. The spirometer sensors are mounted
within the A200SP absorber. Do not fit a
spirometer sensor to any other
location.
The device will not measure exhaled
volumes in any other position.
12. 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 authorized service
technician.
13. 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.
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.
18. 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.
19. In compliance with good anesthesia
practice, an alternative means of
ventilation must be available whenever
the ventilator is in use.
20. It is recommended that the patient
oxygen concentration should be
monitored continuously.
21. 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
14. 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
15. The AV-S ventilator is not intended for
use in intensive care applications.
16. This apparatus must not be used with,
or in close proximity to, flammable
anesthetic agents.
There is a possible fire or explosion
hazard.
17. Anesthesia apparatus must be
connected to an anesthetic 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.
22. An audible alarm indicates an
anomalous condition and should never
go unheeded.
23. 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.
24. Care must be taken to ensure that the
flow sensors are connected correctly
to the inspiratory and expiratory ports
of the absorber.
WARNINGS AND CAUTIONS
4
25. 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, ‘Ventilator Inoperative’ will be
displayed on the front control panel
display.
26. 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.
27. The patient must be continuously
attended and monitored when
Advanced Breathing Modes are in use.
User Maintenance
28. User maintenance is restricted to
cleaning the outside surfaces of
the ventilator, see section 6.
Other procedures detailed in this
manual must be carried out by
trained technicians.
Service and repair operations must
only be carried out by an engineer
trained by the manufacturer.
The warranty for this product is
void if the product is not
maintained in accordance with the
service schedule detailed in
section 6.1, and the procedures
published in the Service Manual for
this product.
Control Unit
29. Opening the control unit by
unauthorized 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.
30. For continued protection against fire
hazards, any replacement fuses must
be the identical type and rating as the
original components. Replacement
must be carried out by trained
technician.
See section 4 for fuse rating.
31. 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.
32. 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.
33. Exterior panels must not be removed
by unauthorized personnel and the
apparatus must not be operated with
such panels missing.
There is a possible electric shock
hazard.
Bellows Assembly
34. The valve seat on the patient gas
exhalation diaphragm valve in the base
of the bellows assembly must be
cleaned regularly. Note that the bellows
assembly is built into the A200SP
Absorber - please refer to User Manual
for this product.
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.
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
CAUTIONS
1. Do not sterilize the ventilator control unit.
The patient block assembly must be
removed from the control unit before
sterilization ( see section 6.2.5).
All other internal components are not
compatible with sterilization techniques
and damage may result.
2. For ventilator components which require
sterilization, peak sterilization
temperatures should not exceed 134oC
(275oF) to prevent possible damage.
(See section 6).
3. Care must be taken not to let any liquid
run into the control unit; serious damage
may result.
4. The exhalation valve located in the
bellows base assembly and the pediatric
bellows adaptor must be cleaned and
sterilized separately. Note that the bellows
assembly is built into the A200SP
Absorber - please refer to User Manual for
this product.
5. 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. Note that the
bellows assembly is built into the A200SP
Absorber - please refer to User Manual for
this product.
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.
6
WARNINGS AND CAUTIONS - Oxygen Monitor
Oxygen Monitor
Note that the sensor for the oxygen
monitor is built into the A200SP
Absorber - for additional information,
please refer to the A200SP User
Manual.
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.
CAUTIONS
1. Do not sterilize any oxygen monitor
component.
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.
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. 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.
6. The oxygen sensor is not suitable for
sterilization.
If contamination is suspected, fit a new
sensor (see section 6.4) and dispose of
the contaminated unit according to
hospital, local, state and federal
regulations.
3. To maintain maximum sensor life:
i) always switch off the anesthetic
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.
2. PURPOSE
7
The AV-S Ventilator is a software controlled,
multi-mode ventilator, designed for
mechanical ventilation of adult and
pediatric patients under general
anesthesia.
In addition, in spontaneous mode, it can be
used to monitor spontaneously breathing
patients
It is designed for use in closed-circuit
anesthesia.
Indications for use of the device:
The AV-S Ventilator is intended to provide
continuous mechanical ventilatory support
during anesthesia. 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
pediatric patients.
The ventilator is intended for use by health
care providers, i.e. Physicians, Nurses and
Technicians with patients during general
anesthesia.
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 anesthesia, and is
intended for adult and pediatric 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 anesthesia.
3. DESCRIPTION
8
1
2
Spontaneous Mode Patient Support
SIMV - Synchronised Intermittent Mandatory Ventilation
SMMV - Synchronised Mandatory Minute Ventilation
PSV - Pressure Supported Ventilation
PEEP - Positive End Expiratory Pressure
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 patient support -
SIMV, SMMV, PSV, 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.
Mounting:
Remote, arm-mounted as illustrated (1) or optional
combined control unit / screen (see section 5.1.1).
Bellows unit
The bellows unit (2) is built into the A200SP absorber.
A pediatric bellows assembly is available as an
option
Drive gas supply
The drive gas supply can be oxygen or air.
The supply must be at 310 to 689 kPa (45 to 100 psi).
Note that the drive gas is specified by the customer,
and set during manufacture. Conversion from one
drive gas to another must only be carried out by an
authorized service engineer trained by the
manufacturer.
9
DESCRIPTION
2
7
3
13 14
15
12
1110
9
8
6
5
4
1
Control Unit
Rear Panel
Gas Connections
1. Ventilator drive gas inlet
- connect to anesthetic machine
auxiliary gas outlet
2. Bellows Drive Gas Output
- connect to bellows via A200SP
absorber - see section 5.1.5
3. Outlet - Exhaust Valve
- connect to scavenge system - see
section 5.1.6
Electrical Connection
4. Electrical mains input and fuse unit
Interface and Parameter inputs
5. A200SP Absorber Bag/Vent
switch interface, and
Spirometer connector
6. Integra AV-S Interface
connector - (primary on/off
switch)
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 (manufacturer’s use only)
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
your distributor’s service department, or
the manufacturer.
3.2 Ventilation Cycle
This section provides a simplified description of the ventilation cycle.
1. Inspiratory Phase
The drive gas proportional
valve (1) in the control unit
opens.
Drive gas is delivered to the
bellows housing (2).
The patient 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 (5),
which starts to move down.
The diaphragm (6) in the
bellows assembly base is
held closed, and patient gas
is forced out of the bellows
base (7) into the breathing
system.
2. Beginning of
Expiratory Phase
The drive gas proportional
valve (1) closes.
The patient proportional
valve (3) closes.
The exhaust valve (4) opens.
Patient gas returns to the
bellows (5).
As the bellows rises,
redundant drive gas is
pushed out through the
exhaust valve.
DESCRIPTION
10
1
4
4
6
7
5
5
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 (6) lifts and
allows gas to exit through
the exhaust valve (4).
4. PEEP
Positive End
Expiratory
Pressure
(user selectable)
The patient 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 (5)
will cause gas to bleed past
the exhaust valve (4).
If there is a fall in pressure in
the breathing circuit, the
continuous flow from the
drive gas proportional valve
(1) helps maintain the set
PEEP pressure.
11
6
4
5
5
12
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 cmH2O
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.
B) Pneumatic Control Manifold Block
7. Drive Gas Proportional Valve
8. Drive Gas Flow Sensor
9. Drive Gas Pressure Sensor
10. Low Pressure Regulator
11. Patient 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)
DESCRIPTION
13
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