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Siesta Its
Siesta Its
Siesta Its
SIESTA i TS
Anaesthesia Machine
Software Version 3.0
Dameca a/s
Islevdalvej 211
DK-2610 Roedovre, Denmark
Phone: +45 44 50 99 90, Telefax: +45 44 50 99 99
E-mail: info@dameca.com, www.dameca.com
User Manual for SIESTA i TS
Important !
We are constantly developing our products, and
consequently reserve the right to make alterations
in design and equipment without prior notice.
DAMECA a/s issues a guarantee against manu-
facturing and material defects for a period of
one year from the date of delivery. Excepted
from this guarantee are rubber articles and
anaesthesia valves with plastic parts.
Dameca I
User Manual for SIESTA i TS
II Dameca
User Manual for SIESTA i TS
Contents
1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3 Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.4 User Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.5 Responsibility of the Manufacturer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.6 Safety Features of the SIESTA i TS Anaesthesia Machine . . . . . . . . . . . . . . . . . . . . . . . 1-4
3. Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.1 Anaesthesia Gas Scavenging System (AGSS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
4. Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1 Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Function Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.3 Operation of Electronic Gas Mixer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
4.4 Operation of Stopwatch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
4.5 Operation of Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
5. Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1 Respiration Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Gas Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Dameca III
User Manual for SIESTA i TS
Contents (continued)
7. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.1 Integrated Breathing System Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Electronic Gas Mixer Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.3 Ventilator Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
7.4 Multigas Module Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
7.5 System Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
7.6 Overview of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
IV Dameca
User Manual for SIESTA i TS
1. Introduction
This manual is related to EGM software An APL (Adjustable Pressure Limiting) valve
version 3.0, ventilator software version is integrated into the IBS, giving the user
2.0 and multigas module (optional) software a choice between manual ventilation or
version B7 or higher. spontaneous breathing.
Dameca anaesthesia machine model SIESTA i A multigas module (optional) which measures
TS is applicable with most types of inhalation respiration rate and inspired and expired
anaesthesia. O2 and N2O, or O2 and AIR can concentrations of O2 , N2O, CO2 and AA
be administered, and anaesthetic vaporizer(s) (anaesthetic agent). The multigas module
is connected to a back-bar. has automatic identification of AA, as well as
identification of a secondary AA, if present.
The gas supply can be obtained from a central
gas supply system or from cylinders. There is The electronic gas mixer, ventilator and optional
no difference in performance when supplied gas module are all microprocessor controlled,
from cylinders. with software installed.
Dameca 1-1
User Manual for SIESTA i TS
1.2 Description
The electronic gas mixer (EGM) of the SIESTA i The IBS uses a CO2 absorber i-SORB which
TS controls the freshgas flow given to the patient contains 900 gr. Sodalime. The absorber is
breathing system. The EGM continuously mea- available as a re-usable or a disposable version.
sures this flow to assure that it is in accordance
with the setting made by the user. If the absorber is disconnected from the IBS,
Besides the EGM controls and displays data two valves automatically close the connections
from electronic gas mixer, ventilator and to the absorber, in order not to loose gases.
optional multigas module on its 15’’ display,
which is touch controlled. The multigas module (optional) of the SIESTA i
TS uses a gas sample from the Y-piece to mea-
The ventilator of the SIESTA i TS uses sure inspired and expired concentrations of O2 ,
compressed AIR or O2 to ventilate the patient N2O, CO2 and AA (anaesthetic agent). Besides,
through the Bag in Bottle system, placed in the multigas module can detect if Ethanol or
the integrated breathing system (IBS). Acetone is expired by the patient, and measure
The ventilator continuously measures airway the concentration. The multigas module has
pressure and inspired/expired volume (optional). automatic identification of AA.
If a multigas module is not installed, the ventila-
tor can also measure inspired O2 by means of a If a secondary AA is present, the multigas
fuel cell sensor (optional) placed on the inspira- module also identifies this, and measures the
tory port of the patient breathing system. concentration.
The integrated breathing system (IBS) of the When gas sample has been measured by the
SIESTA i TS is a semi-closed patient breathing multigas module, it is re-introduced to the pati-
system with one-way valves in both the inspira- ent breathing system, on the expiratory side.
tory and expiratory limb, and an absorber for
eliminating CO2. The system is suitable for high The multigas module does not require re-cali-
flow (app. the patient minute volume), medium bration, as the calibration is stable for life-time.
flow (app. 1-1.5 L/min) and low flow (app.
0.5-1 L/min) of freshgas for patient ventilation. The 3 pcs. integrated power outlets (optional)
of the Siesta i TS are separated from the mains
The IBS is a combination of a Bag in Bottle unit power by a transformer. This transformer
and a patient re-breathing circuit. The IBS has supplies isolated power to the power outlets.
a standing bellows in order for the user to see See section 9 regarding power rating for the
the controlled ventilation of the patient by the power outlets.
movement of the bellows. Besides, in case of
a leakage, room air will not be drawn into the
system, and the leakage can be seen immediately Note:
by the position of the bellows. The parts of the SIESTA i TS do not
contain any latex.
Integrated into the IBS is an APL valve which
is used for manual ventilation only.
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User Manual for SIESTA i TS
The electronic gas mixer of the SIESTA i TS is The integrated breathing system (IBS) of the
designed to give a freshgas mixture selected by SIESTA i TS has an expiratory and inspiratory
the user of: resistance of:
This flow is led through the vaporizer rail, Compliance = 4 ml/hPa with adult tubings
where anaesthetic agent can be added by means (22mm diameter).
of a user selectable vaporizer.
By activating an oxygen by-pass valve, approx. The CO2 absorber i-SORB of the integrated
45 L/min of O2 will be added to the freshgas breathing system (IBS) is designed to optimize
flow, after the vaporizer rail. the flow through the absorber, so that all of the
sodalime is being used.
The SIESTA i TS has an integrated gas
scavenging system which removes excess
gases from an open reservoir. This system
must be connected to an AGSS power unit with
a flow of 30-40 L/min. If an external AGSS
power unit is not available, the SIESTA i TS
can be equipped with an integrated AGSS
power unit (optional).
Dameca 1-3
User Manual for SIESTA i TS
If volume monitor is activated, the volume 1.6 Safety Features of the SIESTA
measurement can be configured in two ways: i TS Anasthesia Machine
Only expired volume Gas supply
If the volume monitor is configured to »only O2, AIR and N2O supply failure alarm. Built-in
exp. volume«, the volume sensor must be placed check valves to prevent reverse flow of gases.
at the expiratory port of the patient breathing
system. The volume monitor will then measure The ventilator, patient suction (optional) and
the expired tidal- and minute-volume only. AGSS power unit (optional) is powered by the
primary driving gas (AIR or O2 , normally AIR).
Full spirometry
If the volume monitor is configured to »full The optional patient suction can also be
spirometry«, the volume sensor must be placed powered by VAC (option).
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User Manual for SIESTA i TS
An MPL (Maximum Pressure Limiting) valve In addition the ventilator has a built-in pressure
opens if the pressure of the freshgas flow to the relief valve which opens at 90 (x100Pa).
auxiliary freshgas outlet exceeds 90 (x100Pa).
Dameca 1-5
User Manual for SIESTA i TS
Flow Diagram
qusjob42.SI1LW6~1.wmf
1-6 Dameca
User Manual for SIESTA i TS
2. Safety Precautions
Read this manual carefully and familiarize Do not use this machine in an environment
yourself with the machine before you start exceeding the EMC levels in EN60601-1-1-2.
to operate the machine.
External patient breathing systems used
Always check the machine for proper function with this machine must conform to EN740
before use. or similar standard.
A WARNING indicates a situation in which Bacterial filters used with this machine must
the user or the patient may be in danger of conform to EN 13328-1 or similar standard.
injury.
An anaesthetic vapour delivery device
A CAUTION indicates a situation that may connected to the machine shall comply
lead to equipment damage or malfunction. with ISO8835-4 or similar standard.
A NOTE indicates a point of particular interest Heat and moisture exchangers used with this
for more efficient and convenient operation. machine must conform to EN ISO 9360 or
similar standard.
Dameca 2-1
User Manual for SIESTA i TS
A patient monitor connected to the patient Ensure that all connections are secure and
breathing system, may cause a leakage, check for proper operation of the machine
even if it is in stand-by mode. before use. In particular the patient breathing
system and O-rings should be checked to
The AGSS must be turned on whenever the ensure that connections are not loose, and
machine is in use. the patient breathing circuit is not leaking.
Do not add, remove or modify any part of The use of antistatic or electrically condu-
the machine, unless authorised by Dameca a/s. ctive breathing tubes when utilizing high
frequency surgery equipment may cause
burns and is therefore not recommended
Explosion hazard in any application of this machine.
No oil or grease should be used in this
machine. This also applies to silicone Constant attention by a qualified individual
based lubricants and inflammable oil or is required whenever a patient is under
grease. Only PTFE based oxygen anaesthesia or connected to a ventilator.
compatible lubricants must be used, Some malfunction of equipment requires
(e.g. DAMECA special grease P/N 36825). immediate action.
The machine is not suitable for use in the When using the ventilator, alternative means
presence of flammable anaesthetic agents for ventilating the patient must be present.
such as ether and cyclopropane. Only
anaesthetic agents complying with EN 740 When operating the machine, an alternative
or similar standards must be used. oxygen supply must always be present.
2-2 Dameca
User Manual for SIESTA i TS
The O2 percentage in the patient circuit may hetic gases in operating rooms. Observe
differ significantly from the O2 percentage that the ball of the flowmarker is visible.
of the freshgas.
Dameca 2-3
User Manual for SIESTA i TS
Vaporizers should be serviced according Do not leave spare cylinder valves open
to the manufacturer’s instructions by an when using the machine on central gas
authorised service centre. outlets.
Use only original DAMECA hoses and Pressure from cylinders may be higher than
accessories; other hoses and accessories the pressure from central outlets, and the
may cause malfunctions. cylinder supply could be depleted.
Use only original DAMECA O-rings; Disconnect the machine from mains and
other O-rings may cause problems if they medical gas supply, when not in use, to
are not of the same size or material. prevent pollution.
Note:
Tubings used with this product must fulfill the EN12342 standard, and
respiration bags must fulfill the EN1820 standard.
2.3 Symbols
2-4 Dameca
User Manual for SIESTA i TS
3. Function
14
13
3
15
12
11 16
4 17
10 18
19
9 20
IBS 8
7 21
6
22
5
23
24
1 1
qusjob42.10653 front.png
Dameca 3-1
User Manual for SIESTA i TS
12
7
11 13
10
9
8
14
6 15
5
4
3
16
2
17
1 1
qusjob42.10653 bag.png
3-2 Dameca
User Manual for SIESTA i TS
5 6 7 8 9
4
10
3
11
12
2
13
14
1
15
16
25 24 23 22 21 20 19 18 17
qusjob42.Fig. 3-3 with gasmodule.pdf
1. Window for set freshgas flow 14. Window for activating »cancel alarms«
2. Window for measured freshgas flow 15. Window for measurement of respiration
3. Window for set O2 percentage in data (optional)
freshgas flow 16. Window for machine status VENT/
4. Window for set total freshgas flow MANUAL/STBY)
5. Window for alarms and messages 17. Window for ventilation mode
6. Window for date and real time 18. Window for more ventilator settings
7. Window for measurement of CO2 19. Window for PSV settings (optional)
concentrations 20. Window for set inspiratory pressure
8. Window for measurement of gas 21. Window for set PEEP
concentrations 22. Window for set I:E ratio
9. Window for stopwatch 23. Window for set respiration rate
10. Window for activating »normal screen« 24. Window for set tidal volume
11. Window for activating setup menu 25. Window for respiratory graph,
12. Window for activating trend menu pressure measurements and
13. Window for activating alarm menu high alarm setting.
Dameca 3-3
User Manual for SIESTA i TS
5 6 7 8 9
4
10
3
11
12
2
13
14
1
15
16
24 23 22 21 20 19 18 17
qusjob42.fig. 3-4 without gasmodule.PDF
1. Window for set freshgas flow 13. Window for activating alarm menu
2. Window for measured freshgas flow 14. Window for activating »cancel
3. Window for set O2 percentage in alarms«
freshgas flow 15. Window for measurement of
4. Window for set total freshgas flow respiration data (optional)
5. Window for alarms and messages 16. Window for machine status
6. Window for date and real time (VENT/MANUAL/STBY)
7. Window for respiratory graph, pressure 17. Window for ventilation mode
measurements and high alarm setting 18. Window for set inspiratory pause
8. Window for measurement of inspired 19. Window for PSV settings (optional)
O2 percentage (optional) 20. Window for set inspiratory pressure
9. Window for stopwatch 21. Window for set PEEP
10. Window for activating »normal screen« 22. Window for set I:E ratio
11. Window for activating setup menu 23. Window for set respiration rate
12. Window for activating trend menu 24. Window for set tidal volume
3-4 Dameca
User Manual for SIESTA i TS
Dameca 3-5
User Manual for SIESTA i TS
3-6 Dameca
User Manual for SIESTA i TS
4. Operation
4.1.1 Integrated breathing system
Note:
Before using the machine the first time
it must be electrical safety tested
according to EN 60601-1, and all
patient related parts must be cleaned.
2
1
5
Note:
3
Before connecting the machine to a
patient, a function test must be carried 6
out as described in section 4.2. 4
Note:
Check voltage rating on the type label
at the rear panel of the machine, qusjob42.10653-00 slange.pdf
Dameca 4-1
User Manual for SIESTA i TS
Note:
The respiration bag must be 1-3 L. Note:
otherwise the leakage test of the The integrated breathing system must
BAG system, included in the selftest, not be changed during use.
may not work correctly.
If the integrated breathing system is
disconnected, a message will be
Set the freshgas switch (24 on fig. 3-1) to shown on the display:
»Circle System«.
»Patientsystem disconnected«.
qusjob42.10653ny.pdf
4-2 Dameca
User Manual for SIESTA i TS
qusjob42.11960uds ab.pdf
1. Take the handle of the absorber. In order to remove excess gases from the
2. Push the knob above the handle of the breathing system, connect it to the to 30 mm
absorber to release it. The two absorber female cone marked AUX AGSS on the
valves will close in order to prevent loss rear of the machine (9 on fig. 3-2).
of gases during change. See section 3.1.1
3. Lift the used absorber out of the bracket.
4. Put the fresh absorber into the bracket. Set the freshgas switch (24 on fig. 3-1)
5. Lift the handle until the lock gives a »click«. to »Aux Outlet«.
6. The absorber is now attached to the patient
system.
Caution:
A bacteria filter should always be used
with the integrated breathing system.
Dameca bacteria filter P/N 38477-50
(50 pcs.) can be used.
Dameca 4-3
User Manual for SIESTA i TS
4-4 Dameca
User Manual for SIESTA i TS
The actual settings for the flow sensor (type and placing) are shown in the window for respira-
tion graph. If flow sensor type and placing are not shown, this means the machine is installed
without any flow sensor.
Note:
A bacteria filter must always be placed between the patient and the flowsensor.
If the external flow sensor is used, tubings between flow sensor and connectors (7 on fig. 3-2)
on the machine must be connected.
Patient port
qusjob41.10967-120.pdf
Caution:
After selftest has been performed, the type of flow sensor (Adult/Paediatric)
must be defined in the setup menu.
Dameca 4-5
User Manual for SIESTA i TS
If an integrated gas module is not installed, the Place the O2 sensor on T-piece
machine can be set up with an O2 monitor (8 on (P/N 42012-07) in the patient
fig. 3-4), which uses an external fuel cell sensor. breathing system on the inspiratory
side. The O2 sensor must always face
Then the main display will look like the upwards.
following:
qusjob41.10967-85.pdf
4-6 Dameca
User Manual for SIESTA i TS
4.2 Function Test If the main switch on front of the machine is set
to ON during this period, the message will dis-
Turn on the mains power inlet switch on appear and the machine will continue to function.
rear side of the machine (5 on fig. 3-2).
If the main switch on front of the machine is NOT
set to ON position during this period, the ma-
Note: chine will power off when the period has ended.
When the mains power switch on
rear side of the machine is turned
on, the batteries inside the machine Note:
will be charged at all times, inde- The integrated breathing system must
pendent of whether the machine is be assembled and connected, incl. hoses,
running or not. Therefore this switch Y-piece and i-SORB CO2 absorber, be-
should be set to ON at all times. fore a function test can be carried out.
Note: Note:
When the main switch on front of If the machine is equipped with an inte-
the machine at a later time is pushed grated multigas module, this module
in order to set it to OFF position, a will not be working until approx. 2 min.
message will be shown on the screen: after activating the main switch on front
»Machine closing down. Press ma- panel. If the machine is equipped with
ins switch to cancel«. Now a power an O2 monitor which uses an external
delay period of app. 20 seconds is fuel cell sensor, this monitor will not be
started. During this the machine working until approx. 1 minute after
will continue to function as before. activating the main switch on front panel.
Dameca 4-7
User Manual for SIESTA i TS
4-8 Dameca
User Manual for SIESTA i TS
2. Gasmixer test
Warning: Display: »Occlude Y-piece (use testadapter)«.
If the FULL selftest is bypassed, the »Check gas evacuation (flow marker)«
compliance and leakage of the integra- »Set APL valve to 35 hPa«
ted breathing system are not measured. »Open vaporizer«
The ventilator therefore uses the data »Press to start«
from last selftest, and therefore the set »If you want to leave this test, press
tidal volume in VCV mode might not normal screen«
be correct.
Place the Y-piece on the test plug at the BAG
connection of the integrated breathing system.
Check the yellow ball in the flow marker
(3 on fig. 3-1) is visible.
Note: Set the APL valve in patient breathing system
If the FULL selftest has been bypassed, (9 on fig. 3-1) to 35 hPa, and open the vaporizer.
the text »SELFTEST BYPASSED« Press the control wheel to confirm.
is shown constantly on the main display.
Display: »Electronic gas mixer test is running«
The internal safety system of the machine The electronic gas mixer generates a flow
(watchdog) and the valves for the electronic of 10 L/min O2 and 9.75 L/min AIR for
gasmixer and the valves for the ventilator 10 seconds to fill the respiration bag.
are checked during this. After this, the airway pressure in the patient
system is checked (should be 25 to 45 hPa).
Dameca 4-9
User Manual for SIESTA i TS
This 30 hPa pressure must be reached within Display: »Leakage in VENT system XXX
10 sec. at an inspiratory flow of 5 L/min., or an ml/min.«
error message will be shown on main display. »Check BiB, connectors and hoses«
»Press to repeat test«
The compliance of the system must be from
2.0 to 10.0 ml/hPa, or an error message will When the control wheel is pressed, the compli-
be shown on main display. ance and leakage test will be performed again.
4-10 Dameca
User Manual for SIESTA i TS
Display: »Set APL valve at pat. circuit to The electronic gasmixer generates a flow of 10
SP. Close vaporizer« L/min O2 and 9.75 L/min. AIR for 10 seconds to
»Press to continue« remove any anaesthetic agent from the patient system.
Set the APL valve to SP and close the vaporizer. Then the nex text appears on the display.
Press the control wheel to confirm.
Display: »Check alarm sound present«
Display: »Valve check running« »Press cancel alarms to confirm«
When a 30 hPa pressure is reached on the Check that the alarm sound is present, and press
outside of the bellows of the Bag in Bottle, »cancel alarms«. Then the next text appears on
with the BAG/VENT valve in BAG position, the display:
the leakage from the BAG/VENT valve and
from the expiration and peep valves inside the Display: »Test completed. Check pat.
ventilator is checked based upon the pressure suction, vaporizer etc.«
drop during time. »Adjust APL valve«
»Remove Y-piece from test adapter«
If the pressure drop is too high the ventilator »If vol. monitor is installed, sensor
gives an error message: must be connected and defined«
»Read user manual«
Display: »Leakage in BiB system too high« »Press to finalize«
»Check BiB and change-over valve«
»Press to repeat test« The APL valve should be adjusted as
desired by the user.
When the control wheel is pressed, the leakage Y-piece should be removed from the testadapter
test for the BAG/VENT valve and the expiration If the machine is set-up with volume monitor,
and peep valves inside the ventilator will be the type of sensor (Adult or Paediatric) must
performed again. be defined in the setup menu by the user.
When the control wheel is pressed, the
machine goes to STBY mode and all user
7. Test completed settings are set to default values.
Display: »Leakage in VENT system: XXX Then the manual part of the selftest should
ml/min« be performed, as described in section 4.2.3 to
»Compliance in VENT system: X.X 4.2.15
ml/hPa«
»Press to continue«
4.2.2 LC self test
When the control wheel is pressed, the next text The LC (Leakage and Compliance) test can be used
appears on the display: for measuring compliance and checking for leak-
age if parts of the patient system (f. ex. hoses and
Display: »Refreshing gases in patient system« respiration bag) have been changed between two
patients.
Dameca 4-11
User Manual for SIESTA i TS
During the LC selftest the compliance of the Change between Y and N by turning the
system is measured, and the leakage is checked. control wheel, and press enter to select.
The compliance and leakage test includes the in- By selecting Y the LC selftest is bypassed.
tegrated breathing system incl. hoses and Y-piece. By selecting N the LC selftest is started
again, from the beginning.
When LC TEST is selected by the user (by
selecting »LC TEST« in the selftest menu,
included in the setup menu, and pressing the Warning:
control wheel), the following test sequences If parts of the patient system have
are activated. been changed and the LC selftest is not
performed, the compliance and leakage
of the integrated breathing system are
Note: not measured. The ventilator therefore
During the LC selftest all alarms uses the data from last selftest, and
are disabled. therefore the set tidal volume in VCV
mode might not be correct.
Test sequences:
Start-up
Note:
Display: »Do you want to perform LC TEST: If the LC selftest has been bypassed,
Y/N« the text »SELFTEST BYPASSED« is
»Patient must NOT be connected shown constantly on the main display.
during test«
»Select Y or N and press to continue«
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1. Set status to MANUAL. Y-piece must be 1. Attach a test lung to the Y-piece and start
open to ambient air. the ventilator in VCV mode. Wait approx. 1
minute and read the measured expired minute
2. Set freshgas flow to 10 L/min AIR, and wait volume on main display. Check that this
until O2 % reading on main display is stable. corresponds to the set minute volume
Check that the reading is 20-22 % O2. If not, (TVset x RRset). Check that the insp. and
recalibrate the O2-monitor as described in exp. valves in the patient system are moving
section 6.1.6. during inspiration/expiration.
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1. Set freshgas flow 1 L/min O2 and 1 L/min If the machine is equipped with a patient suction
N2O. Disconnect O2 gas supply to the ma- unit, the user must check the functionality of
chine from the gas outlet and wait until the this unit by the following procedure:
O2 flow column on main display goes to zero.
1. Fully open the regulator on the suction unit.
Check that the »O2 supply pressure is low«
alarm is active, and check that the N2O flow 2. Remove the plastic tubing from the suction
column is also zero. Re-connect O2 gas supply. container and block the tube opening.
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Note:
The freshgas flow can not be activated Note:
if the machine status is STBY. Change The N2O supply is cut-off in case of
to MANUAL or VENT in order to an oxygen failure. When reducing the
open freshgas flow. O2 flow, the N2O flow will be reduced
proportionally, securing a minimum
of 25% O2 in the freshgas. N2O will
be cut of at an O2 flow less than
100 ml/min.
Note:
The O2 percentage is a calculated
value based upon the measured flow
data, and not a value measured by an 4.3.2 Changing carrier gas
oxygen analyser. In case of a hospital If the machine is set up with both AIR and
pipeline cross connection, incorrect N2O as carrier gas for O2, this carrier gas
values will result. can be changed in the setup menu.
The O2 percentage in the patient Press the setup menu field (11 on fig. 3-3)
breathing system may differ signifi- and the first line of the menu will say
cantly from the O2 percentage of Carrier gas.
the freshgas. Press enter on the control wheel to activate
the Carrier gas setting.
Turn the control wheel to the desired carrier
gas, and press enter on the control wheel to
confirm the new setting.
Note: The gas flow beside the O2-flow will now
If the O2, AIR or N2O driving gas change to the selected carrier gas. Besides
the carrier gas flow will change to the last
pressure is lower than 2,5 (x100 kPa)
known flow setting for this specific gas.
the appropriate alarm is activated.
Leave the menu by pressing the normal
screen field.
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When the machine is turned OFF or the FULL selftest or the LC selftest has been performed,
the settings of the electronic gas mixer will change to default values:
Start the stopwatch by pressing the Reset the stopwatch by pressing the
»stopwatch« field. »stopwatch« field twice (double-click).
This can only be done when the stopwatch
The colour of the HH:MM:SS will change is stopped.
from grey to green and the stopwatch will
start to count.
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When the selftest is completed the machine is In PCV mode the set inspiratory pressure above
in stand-by mode, ready for automatic ventilation PEEP is applied to the patient during inspira-
after adjustment of the ventilation parameters. tion, by a decelerating inspiratory flow.
The following parameters can be set when the
machine status is »STBY«, »MANUAL« or This inspiratory flow is adjusted continuously
»VENT«. by the ventilator in order to reach the set
inspiratory pressure and hold this pressure du-
A. Ventilation mode ring the inspiration phase, independent of sy-
During automatic ventilation the following stem compliance and actual freshgas flow.
ventilation modes are available:
If the set inspiratory pressure is not reached
VCV (Volume Controlled Ventilation) during inspiration, the ventilator generates a
PCV (Pressure Controlled Ventilation) PRESSURE LIMIT alarm (see section 7.3.8).
SIMV (Synchronized Intermittent Mandatory
Ventilation) (optional) In SIMV mode the patient can trigger a VCV
PSV (Pressure Supported Ventilation) inspiration during the expiration phase by
applying a decrease of the airway pressure in
In VCV mode the set tidal volume is delivered the patient system. In the ventilator settings
to the patient during inspiration by a constant menu the user can define at which decrease
inspiratory flow. of the airway pressure a VCV inspiration
This inspiratory flow is adjusted continously should be triggered. The decrease of the airway
by the ventilator in order to deliver the set pressure is relative to the set PEEP. If the patient
tidal volume to the patient, independent of has not triggered an inspiration during the
system compliance and actual freshgas flow. expiration phase, the ventilator automatically
VCV is also known as »CMV« or »IMV«. gives a VCV inspiration.
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The time where the patient can trigger an inspi- the set resp. rate in SIMV is decreased, to force
ration is called »trigger-window«. This trigger- the patient to start spontaneous breathing
window is calculated when the mode is changed during wake-up, the trigger-window is kept
to SIMV and is equal to the cycle time (inspira- at the end of the expiration phase, see picture
tion + expiration) of the previous mode. When below:
Trigger-window:
Trigger-window:triggering
triggeringpopossible
ssible
For security reasons the patient can never Therefore the trigger-window is limited, so
trigger a new inspiration, when the ventilator that it can never enter the inspiration-time
is already performing an inspiration, and just plus a 200 msec. period thereafter
after an inspiration has taken place. The patient can only trigger one inspiration in
each trigger window.
In SIMV mode the tidal volume and inspiration If the Resp. rate, or Insp. pause is changed, the
time should be the same as it was in VCV mode, ventilator automatically calculates a new
even when the user prolongs the expiration I:E ratio, in order to keep the inspiration
time to force the patient to start spontaneous time the same.
breathing during wake-up.
Example:
Therefore the setting of inspiration time and Default settings and Resp.rate is set to 20.
volume is different in SIMV mode. This gives an inspiration time of 1 sec.
If SIMV mode is selected and the resp.rate is
Inspiration time: then set to 10 (in order to increase expiration
The inspiration time in SIMV mode is shown time in SIMV), the I:E ratio is automatically
beneath the »I:E ratio« setting. changed from 1:2 to 1:5, in order to keep the
inspiration time at 1 sec.
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In SIMV mode the I:E ratio can go from 1:1 If the user wants to change the tidal volume in
to 1:9.9, since inverse I:E ratio is not allowed SIMV mode, select »MV set« and adjust with
in SIMV mode. Therefore Resp. rate and Insp. the control wheel. When the set minute volume
pause cannot be adjusted to a setting which is adjusted, the new tidal volume is shown on
gives an I:E ratio outside the 1:1 to 1:9.9 the display. However this new setting will not
be effective until the control wheel is pressed.
Example:
Default settings and resp.rate is set to 20.
This gives an inspiration time of 1 sec. Note:
If SIMV mode is selected, the resp.rate can In the service-menu it can be defined
be set from 6 resp/min (gives I:E ratio of 1:9.0) whether SIMV mode shall be available
to 30 resp/min (gives I:E ratio of 1:1). or not. This definition can be changed
by a super-user or a technician.
If the user wants to change the inspiration time
in SIMV mode, select »I:E ratio« and adjust
with the control wheel. When the I:E ratio is
adjusted, the new inspiration time is shown on In PSV mode it is only the patient who controls
the display. However, this new setting will not the ventilator, as the ventilator does not give any
be effective until the control wheel is pressed. mandatory inspirations to the patient. Therefore
this mode is for patient with a certain degree of
Set volume: spontaneous respiration, where the ventilator
If the ventilator is installed with »Minute assists the respiration of the patient.
volume« as set volume, the tidal volume in
SIMV mode is shown beneath the »MV set« Inspiration:
setting. When the patient starts an inspiration, and the
inspiratory flow at the Y-piece (measured by the
If the Resp. rate is changed, the ventilator flow sensor) is higher than the set »Insp. trig.«,
automatically calculates a new minute volume the ventilator starts an inspiration, to reach the
setting in order to keep the tidal volume the set »Support pressure«.
same.
When this »support pressure« is reached, the
Example: ventilator maintains the pressure in the rest of
Default settings and Resp. rate is set to 20. the inspiration phase.
This gives a tidal volume of 300 ml.
Expiration:
If SIMV mode is selected, and the resp.rate The inspiration stops and the expiration starts if
is then set to 10 (in order to increase expiration one of the following conditions are met:
time in SIMV), the set minute volume is
automatically changed from 6.0 to 3.0, in 1. The pressure reaches the »high alarm«
order to keep the tidal volume at 300 ml. (same as for the other ventilation modes).
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2. The inspiration time is more than 2.5 sec. B. Tidal volume/Minute volume (active in
(if flow sensor is »Adult«) or 1.5 sec. VCV or SIMV mode only)
(if flow sensor is »Paed.«) The tidal volume/minute volume delivered
by the ventilator in VCV or SIMV mode is
3. The patient inspiratory flow at the Y-piece automatically compensated for the compliance
(measured by the flow sensor) is lower than of the breathing system and for the freshgas
the set »Exp. trig«. flow.
The »Exp. trig.« is set as a % of the measured
peak flow during inspiration. TV,patient = TV,ventilator + TV,freshgas -
TV,compliance
Ventilation backup:
If the patient does not trigger an inspiration During automatic ventilation in VCV or SIMV
before the »PSV backup« period has ended, a the ventilator automatically calculates the
»PSV BACKUP MODE ACTIVATED, correct inspiratory flow to give the patient the
SWITCHING TO PCV« alarm starts (see section desired tidal volume/minute volume, indepen-
7.3.14) and the ventilator automatically switches dent of other ventilator settings (respiration
to PCV mode. rate, I:E ratio, inspiratory pause etc.) and of
the compliance and freshgas flow.
The alarm disappears when the »cancel alarms«
button is pressed. Press the TV set / MV set field and select the
desired tidal volume / minute volume with the
control wheel (17 on fig. 3-1).
Note: Press the control wheel to confirm the selected
tidal volume/minute volume.
PSV mode is an option which can be
installed on the machine by Dameca The tidal volume/minute volume will not
or an authorized technician. change until the control wheel is pressed.
In the service menu it is defined whether the set
volume should be tidal volume or minute volume.
This definition can be changed by a super-user
or a technician.
Note:
PSV mode is only available if the (Minute volume = Tidal volume x Resp. rate).
volume sensor is placed at the Y-piece.
C. Respiration Rate
The number of controlled respirations pr. minute.
Press the RR set field and select the desired
Press the Vent. mode field and select the desired respiration rate with the control wheel
mode with the control wheel (17 on fig. 3-1). (17 on fig. 3-1). Press the control wheel to
Press the control wheel to confirm the selected confirm the selected respiration rate.
mode. The ventilation mode will not change The respiration rate will not change until the
until the control wheel is pressed. control wheel is pressed.
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D. I:E Ratio Press the PEEP field and select the desired
The timing between the inspiratory and the PEEP with the control wheel (17 on fig. 3-1).
expiratory phase. Press the control wheel to confirm the selected
PEEP.
Press the I:E Ratio field and select the desired
I:E ratio with the control wheel (17 on fig. 3-1). The PEEP will not change until the control
Press the control wheel to confirm the selected wheel is pressed.
I:E ratio.
The I:E ratio will not change until the control Note:
wheel is pressed. PEEP + Inspiratory Pressure can
max. be 70 hPa.
Note:
Some combinations of tidal volume,
respiration rate, I:E ratio and inspiratory
pause cannot be set on the ventilator, Note:
because the continous inspiratory flow PEEP cannot be set above the High
must be between 2 and 80 L/min. alarm setting.
If the 2 L/min. or the 80 L/min. limit
is reached, a message will be shown
on the display.
F. Inspiratory Pressure (active in PCV
mode only)
The inspiratory pressure above PEEP applied
Inspiratory flow = Tidal volume x respiration to the patient in PCV mode.
rate x ((I+E)/I) ) x (100/(100-insp.pause %)).
The ventilator controls the inspiratory flow
Example on min. inspiratory flow: in order to reach this pressure during start
Tidal volume = 20ml, I:E = 1:2, Insp. pause = 0 of inspiration.
These settings give a min. respiration rate of 34.
When the set inspiratory pressure above PEEP
Example on max. inspiratory flow: is reached, the ventilator makes a pressure
Respiration rate = 20, I:E = 1:2, Insp. pause = 0 plateau until the expiration phase.
These settings give a max. tidal volume of 1330ml.
Press the P insp. field and select the desired
E. PEEP inspiratory pressure with the control wheel
The ventilator can generate PEEP (Positive (17 on fig. 3-1).
End Expiratory Pressure). Press the control wheel to confirm the selected
inspiratory pressure.
If PEEP is set to OFF, the PEEP in the patient
system will be app. 3 hPa (depending on the The inspiratory pressure will not change until
freshgas flow) due to the Bag in Bottle system. the control wheel is pressed.
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When the machine is turned OFF or the FULL selftest or the LC selftest has been performed,
the settings of the ventilator will change to default values:
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5. Measurements
The Siesta i TS performs a number of measure- In the spirometry menu the user can change the
ments, depending on the configuration of the placement of the flow sensor. However the ma-
machine. chine will always go back to default value, after
selftest or when the machine is powered OFF.
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The multigas module measures the gas concentrations based upon a sample taken from the
Y-piece.
This sample flow is 200 ml/min, and is re-introduced to the patient breathing system,
on the expiratory side.
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6. User Menus
Siesta i TS has a number of menus that can The following settings can be accessed in
be accessed by the user: the setup menu:
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User Manual for SIESTA i TS
When patient data is selected, a sub menu will MAC corrected = MAC x 10(-0,00269 x (40-age))
appear on the display, with the following settings:
according to W.W. Mapleson in British Journal
Age of Anaesthesia 1996; 76: 179-185
Ideal Weight
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Note:
The spirometry menu is present, only 6.1.3 Graph
if volume sensor is activated in the
service menu. When graph is selected, a sub menu will appear
on the display with the following settings:
The user must define whether an Adult or a Type (only if it is defined in the service
Paediatric flow sensor is used in the patient menu that volume sensor is placed at
system for measurement of volumes. the Y-piece).
T-scale.
Adult sensor: Tidal Volume 200 to 1500 ml
(insp./exp. flow 10-120 L/min.) In this menu the settings for the respiration
graph shown on the display can be defined.
Paed. sensor: Tidal Volume 20 to 300 ml Actual selection is highlighted.
(insp./exp. flow 2-35 L/min.) Activate the setting by pressing the control
wheel (17 on fig. 3-1).
The selected sensor is shown on the display. Change the setting by turning the control wheel
The user can also define where the volume and press enter to confirm.
sensor is placed, in the patient circuit The setting will not change, before enter is
(At Y-piece, At EXP cone or no sensor). pressed on the control wheel
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User Manual for SIESTA i TS
By selecting type, the user can decide which re- The setting will not change, before enter is pres-
spiration graph should be shown on the display. sed on the control wheel.
The user can choose between the following
types of graphs: By selecting Insp. pause the user can set a
certain percentage of the inspiratory time, in
Time-Pressure curve which the ventilator should stop the inspiratory
Pressure-Volume loop flow, before switching to expiration. Thereby
a pressure plateau is added to the inspiration.
By selecting T-scale, the user can decide the re-
solution of the time-scale on the time-pressure
graph. Note:
Setting an insp. pause will affect the
Parameter Factory set value Limits inspiration in VCV and SIMV mode
Graph type Time-Pressure Time- only.
Pressure
Pressure-
Volume
T-scale 20 sec. 10, 20, 30, If the machine is installed with SIMV, the
60 sec. patient can trigger an inspiration during the
expiration phase, by applying a decrease of
the airway pressure in the patient system.
By selecting SIMV trig point the user can de-
6.1.4 Vent. settings fine at which decrease of the airway pressure
When Vent. settings is selected, a sub menu this VCV inspiration should be triggered.
will appear on the display, with the following The decrease of airway pressure is relative to
settings: the set PEEP.
In this menu the secondary settings for the By selecting PSV backup the user can define
ventilator can be defined. the length of this PSV backup time.
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6.1.5 Selftest
When selftest is selected, a sub-menu will appear
on the display, with the following settings: Note:
The O2 % calibration menu is present,
Full test only if multigas module is not installed,
LC test and O2 monitor with external fuel cell
sensor is activated in the service menu.
In this menu the full selftest or the LC selftest
can be started.
Actual selection is highlighted.
Start the selftest by pressing the control wheel
(17 on fig. 3-1).
See section 4.2 regarding selftest.
Note:
The O2 sensor should be placed on the
Note: inspiratory port of the patient breathing
Full test and LC test can only be select- system. Use T-piece (P/N 42012-07),
ed if the machine is in STBY mode. and place O2 sensor facing upwards.
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6.1.8 Clock
When clock is selected, a sub menu will appear
on the display, with the following settings:
Day
Note:
Month If the full selftest or LC test has been
Year carried out, or the machine has been
Hour powered OFF, the settings and data
Minute will automatically be reset.
Second
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By selecting 1. to 5.column, the user can design entered the super-user password in the service
the contents of the trend tables. However, these menu (see section 6.1.9).
settings are not available unless the user has
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User Manual for SIESTA i TS
By selecting rate, the user can define the inter- 6.2.1 Selftest data
val between the logging of trend information.
Rate can be selected from 1 second to 10 min. By selecting selftest data, a sub menu is
Default value is 5 minutes. activated.
If the machine is installed with printer option, In this sub menu the user can view information
the user can get a print out of the trend data, by regarding the last performed selftest:
selecting print.
Test type
By selecting reset, the user can reset all the Test time
trend data. Leakage in VENT system
Compliance in VENT system
Note:
If reset has been selected, the trend 6.2.2 Gas usage
data cannot be restored.
By selecting Gas usage, as sub menu is
activated.
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When status is »MANUAL«, the alarms When gas measurement alarms is selected, a
for Exp/Insp CO2 and Respiration rate can sub menu will appear on the display, with the
be disabled by setting »CO2 alarms« to OFF following settings:
in the alarm menu.
Insp O2 high Exp CO2 high
On the display is shown whether the CO2 Insp O2 low Exp CO2 low
alarms are set to ON or OFF. Exp O2 high Insp AA low
Exp O2 low Exp AA low
When status is changed to »STBY« or »VENT«, Insp N2O high Insp AA high
»CO2 alarms« are automatically set to ON, Insp CO2 high Exp AA high
and the alarm limits for Exp/Insp CO2 and Insp CO2 low
Respiration rate are set to default values.
Besides »CO2 alarms ON/OFF« is no longer
shown on the display, and can no longer be In this menu, the alarm limits for the gas
selected in the alarm menu. concentrations measured by the multigas
module can be defined.
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* The values for Insp CO2 High/Low and Exp CO2 High/Low are dependent upon the unit
for CO2 measurements (%, kPa or mm Hg), as defined by the user in the setup menu.
For example, if TV set is 500 ml and RR set is 12, the set minute volume is 6.0 L, and the
alarm limits will then be:
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Once the user sets the High MV exp or the Low 6.3.5 Alarm log
MV exp alarm limit, these limits are no longer
set +/- 33 % around the minute volume for the When alarm log is selected, the alarm log
ventilator, but will remain »fixed«. menu appears on the right side of the display.
The actual alarm log data are shown in the
When a FULL selftest or a LC selftest has been center of the display.
carried out, the functionality of the automatic Select a setting by turning and pressing the
setting is regained. control wheel (17 on fig. 3-1).
The following settings can be accessed in the
alarm log menu:
Note:
Both alarm limits are automatically Page
set to »OFF« when the anaesthesia Print (only if print option is installed)
machine status is set to »STBY« or Reset
»MANUAL«. However the user can
still change these alarm limits. When the alarm log menu is activated, the latest
data are shown
Table A
Time Alarm
HH:MM:SS
If the machine si installed with printer option, the user can get a print out of the alarm log,
by selecting print.
By selecting reset, the user can reset all the alarm log data.
Note:
If reset has been selected, the alarm log data cannot be restored.
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Note:
If FULL selftest or LC test has been carried out, or the machine has been powered
OFF, the alarm log is automatically reset.
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7. Alarms
The Siesta i TS anaesthesia machine has a built- Patient system disconnected
in alarm system for all the measured parameters, Absorber disconnected
as well as for the safe function of the machine.
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7.2.1 O2 flow is critical low 7.2.3 Electronic gas mixer fan stopped
The »O2 flow is critical low« alarm is activated, The »electronic gas mixer fan stopped« alarm
if the O2 freshgas flow is set to less than is activated, if the upper fan placed on the
300 ml/min. upper rear panel is stalled (12 on fig. 3-2).
This is done in order to prevent unintended Take off the filter placed in front of the fan,
setting of a low O2 freshgas flow. and check whether the fan is working.
If the O2 freshgas flow is increased to a value
above 300 ml/min, the alarm will stop.
Note:
The filter placed in front of the fan
Note: should be cleaned regularly.
Whenever the O2 freshgas flow is set New filter has P/N 36715-01.
to less than 300 ml/min, the alarm will
appear, but the alarm sound will not be
repeated. 7.2.4 O2/AIR/N2O freshgas flow is
out of control
The »O2 freshgas flow is out of control« alarm
is activated, if the measured O2 freshgas flow
7.2.2 O2/AIR/N2O pressure is low (shown as bargraph) does not match with the
The »O2 pressure is low« alarm is activated, if set flow (shown as digits).
the O2 inlet pressure to the machine is less than The »AIR freshgas flow is out of control« alarm
2.5 (x100 kPa). is activated, if the measured AIR freshgas flow
The »AIR pressure is low« alarm is activated, (shown as bargraph) does not match with the set
if the AIR inlet pressure to the machine is less flow (shown as digits).
than 2.5 (x100 kPa). The »N2O freshgas flow is out of control« alarm
The »N2O pressure is low« alarm is activated, is activated, if the measured N2O freshgas flow
if the N2O inlet pressure to the machine is less (shown as bargraph) does not match with the set
than 2.5 (x100 kPa). flow (shown as digits).
The alarm sound can be cancelled for 2 minutes,
but the alarm itself cannot be cancelled. Check If the alarm does not disappear after app.
that the relevant gas is connected to the gas inlet 10 seconds, and an »O2/AIR/N2O pressure
of the machine (8 on fig. 3-2). If this is OK, then is low« alarm is not present at the same time,
check the inlet pressure for the gas in question. call for technical assistance.
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When the battery capacity is so low that the 7.3 Ventilator Alarms
electronic gas mixer and the multigas module
cannot be powered by the battery, »closing The following alarms are in relation to the
down« is also shown on the display. ventilator:
After approx. 20 sec. the machine will automati-
cally power off in order not to discharge the Airway pressure high
battery completely. System pressure high
Connect the machine to mains in order for the Disconnection
electronic gasmixer battery to re-charge. Drivegas low
The machine can be used when the battery has Ventilator fan stopped
been charged to a safe capacity. Ventilator battery low
System pressure
Pressure limit
Note: Freshgas high
During an »electronic gasmixer battery Insp. O2 % high/low (only if multigas
low« alarm, the audible alarm cannot module is not installed, and O2 monitor
be disabled. with external fuel cell sensor is activated
in the service menu)
Expired minute volume high/low (only if
volume sensor is activated in the service menu)
Ventilator mains power failure
7.2.6 External freshgas outlet activated
The »external freshgasoutlet activated« alarm is
activated if the external freshgasoutlet on the
7.3.1 Airway pressure high
machine is activated. The »airway pressure high« alarm is activated
if the measured pressure in the patient breathing
During the alarm, the ventilator cannot be started. system is higher than the high alarm limit.
If the ventilator is running when the alarm is
activated, a »ventilator stopped due to external When the airway pressure reaches the high
freshgasoutlet activated« alarm is activated, pressure alarm limit, the ventilator goes to
the ventilator is stopped and status changed expiration phase to avoid dangerous over-
to MANUAL. pressure situations.
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Note: Note:
During an »airway pressure high«
alarm, the freshgas flow will automati- If PEEP is set to OFF the limit is 5 hPa,
cally be set to 0.3 L/min O2, in order based on PEEP being 3 hPa due to Bag
to avoid dangerous over-pressure situa- in Bottle.
tions in case of high freshgas flow.
When the alarm is no longer active, the
freshgas flow will automatically be set
to the orginal values. PS: This functio- 7.3.4 Drivegas low
nality can be disabled in the service-
menu, by a super-user or a technician. The »ventilator drivegas low« alarm is activated
if the dynamic driving gas pressure at the
ventilator is less than 2.5 (x100kPa).
7.3.2 System pressure high
The »system pressure high« alarm is activated if
the ventilator pressure to Bag in Bottle is more
7.3.5 Ventilator fan stopped
than 10 hPa higher than the »high alarm« limit. The »ventilator fan stopped« alarm is activated,
This could be due to the bellows in the Bag in if the lower fan placed on the lower rear panel
Bottle system being empty. is stalled (2 on fig. 3-2).
When the Bag in Bottle pressure reaches the
high pressure alarm limit +10 hPa, the ventilator Take off the filter placed in front of the fan, and
goes to expiration phase to avoid dangerous check whether the fan is working.
over-pressure situations.
The alarm condition will end, when one respira-
tion without reaching the limit has passed. Note:
The filter placed in front of the fan
Note: should be cleaned regularly. New
filter has P/N 36715-01.
During a »system pressure high« alarm,
the freshgas flow will automatically be
set to 0.3 L/min O2, in order to avoid
dangerous over-pressure situations in
case of high freshgas flow. When the 7.3.6 Ventilator battery low
alarm is no longer active, the freshgas The »ventilator battery low« alarm is activated,
flow will automatically be set to the if the capacity of the internal battery for the
orginal values. PS: This functionality ventilator is too low to secure proper function
can be disabled in the service-menu, of the ventilator during a mains power
by a super-user or a technician. failure.
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After approx. 20 sec. the ventilator will The alarm is generated in order for the tidal
automatically power off in order not to volume given to the patient not to be higher
discharge the battery completely. than the set tidal volume
Increase the tidal volume setting or decrease the
Connect the machine to mains and turn ON the freshgas flow in order for the alarm to disappear.
machine in order for the ventilator battery to
re-charge. The ventilator can be used when the
battery has been charged to a safe capacity.
7.3.10 Inspired O2 % high/low (only if
external O2 fuel cell sensor is
installed)
Note: The »inspired O2% high« alarm is activated if
During a »ventilator battery low« the O2% measured by the external O2 sensor
alarm, the audible alarm cannot be is higher than the alarm limit.
disabled. The »inspired O2% low« alarm is activated if
the O2% measured by the external O2 sensor
is lower than the alarm limit.
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The »inspired CO2 % low« alarm is activated When ethanol is not identified any longer, the
if the CO2 % measured by the multigas module alarm is cancelled.
is lower than the alarm limit.
7.4.8 Gas measurements is in standby
7.4.4 Inspired/expired AA % high/low mode
The »inspired AA % high« alarm is activated The »gas measurement is in standby mode«
if the AA % measured by the multigas module alarm is activated when the multigas module
is higher than the alarm limit. goes to stand-by mode, where the sample-flow
pump is stopped.
The »inspired AA % low« alarm is activated
if the AA % measured by the multigas module The stand-by mode is activated if the status is
is lower than the alarm limit. STBY or MANUAL, freshgas flow is closed
and respiration rate is not detected, and this has
been the situation for more than 10 min. This is
7.4.5 Resp. rate high/low done to increase the lifetime of the sample-flow
The »resp. rate high« alarm is activated if the pump in the multigas module.
respiration rate measured by the multigas »Open freshgas flow or start ventilation to
module is higher than the alarm limit. activate« is shown as additional information.
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When freshgas flow or ventilation is started, Check that the water trap is not filled with
the multigas module is activated again, and the liquid. Replace if necessary.
measurement of gas concentrations is running
after app. 20 sec.
7.4.11 Invalid O2 sensor offset
The »invalid O2 sensor offset« alarm is given if
7.4.9 Occlusion the sensor used for measurement of O2 cannot
The »occlusion« alarm is activated if the be calibrated by the gasmodule.
multigas module cannot achieve a sample flow.
If this alarm happens, go to setup menu, select
Check that the sample-tube between Y-piece and gas meas. setup menu and select »Gasmodule
water trap is not blocked. Replace if necessary. ini« in order to restart the gas module and
perform a new calibration.
Check that the water trap is not filled with
liquid. Replace if necessary.
7.4.12 Ambient CO2 too high
The gasmodule draws room air into the
Note: measuring chamber at certain intervals, in
If the »occlusion« alarm has been order to calibrate the module.
active for more than one minute, the However, if the measured CO2 concentration
sample flow will stop, in order to of the ambient (room) air is too high for the gas-
protect the samplepump. module to calibrate, the »ambient CO2 too high«
When the sample-tube and/or watertrap alarm is given.
has been replaced, press »Exp. CO2«
in order to restart the samplepump. If this alarm happens, increase the ventilation
of the room in which the machine is placed.
Then go to setup menu, select gas meas. setup
menu and select »Gasmodule ini« in order to
restart the gas module and perform a new
Note: calibration.
The water trap should be replaced
minimum every 3 months.
7.4.13 Sample cell pressure out of range
The »sample cell pressure out of range« alarm is
given if the pressure measured in the measuring
7.4.10 Sampleflow rate error chamber inside the gasmodule is too high or to low.
The »sampleflow rate error« alarm is given if This could be caused by an obstruction in the
the sampleflow measured by the gasmodule is sample flow line.
not according to the specifications.
This could be caused by an obstruction in the Check that the sample-tube between Y-piece
sample flow line. and water trap is not blocked. Replace if necessary.
Check that the sample-tube between Y-piece and Check that the water trap is not filled with
water trap is not blocked. Replace if necessary. liquid. Replace if necessary.
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Gas module RED correctable If the mains switch is not activated again, the
If this alarm is activated, the gas measurement machine will power down after approx. 20 sec.
data cannot be used. The type of error leading to If the mains switch is activated again within the
this alarm can possibly be corrected by the user approx. 20 sec., the machine will not power
or the gasmodule. down, but continue to function as before.
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* Default values for »Insp AA High« and »Exp AA High« depend on the anaesthetic agent
identifed by the mutigas module:
HAL ENF ISO SEV DES
Insp AA High 2.2 % 5.1 % 3.4 % 5.1 % 18 %
Exp AA High 1.5 % 3.4 % 2.3 % 3.4 % 12 %
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8.1 Maintenance
Preventive maintenance of the machine must be
carried out at least once a year by an authorized
technician.
Function control
Integrity control
Cleaning
8.2 Cleaning
8.2.1 Anaesthesia machine
Wipe the surface of the machine with a soft
qusjob42.11960-96.png
cloth moistened with mild soapy water or Fig. 8-1 IBS Patient System Overview
isopropyl alcohol. Wipe the machine with
a dry cloth.
Remove the bottle (1), and remove bellows (2).
Remove the cover (3), and remove the
Caution: membrane (4).
Remove the APL valve (5) (note the release
Avoid abrasive and corrosive cleaning
button at the side of the IBS body).
agents as they may damage the ma-
Remove the caps (6) for the insp/exp valves
chine. Avoid organic fluids as acetone,
(7), and remove the valves.
turpentine, thinner or similar.
Remove absorber valves: Inspiratory valve
(8) marked C and the expiratory valve (9)
marked B. To help disassemble the valves
use the tool (11).
Remove change-over valve (10) marked A.
8.3 IBS Patient Breathing System To help disassemble the valve use the tool (11).
Before cleaning, the integrated patient breathing The IBS Patient System and the parts can
system must be disassembled as follows: now be cleaned and sterilized.
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Note:
Alcohol must not be used for disinfection.
Note:
Some disinfectants, such as phenol and
aldehyde compounds, can be absorbed
and accumulated in plastic and rubber
parts, when disinfection has taken
place repeatedly.
qusjob42.11960-96.png
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Mount the insp/exp valves (7) with the If a re-useable CO2 absorber (i-SORB) is used
groove in the valve body fitting the pin in with the integrated patient breathing system,
the IBS body. Check that the valves are change the two filters (4) (40 pcs. has P/N 11040-40).
mounted correctly by carefully pushing the
valves in. Check that the membranes have Place one filter at the bottom of the absorber
no visible damages. Change the membranes canister (1) and fill with absorbent.
if they are damaged (use valve P/N 11890-31).
Do not touch the valve flap.
The following types of absorbent can be used:
Mount the valve caps (6). Sofnolime, Medisorb, Prosorb, Sodalime, Lime-
pak, Agasorb, Sefasorb, Carbolime, Chemosorb,
Mount change-over valve (10) marked A. Vitalime and Ventisorb.
To help assemble the valve use the tool (11).
Apply a thin film of special grease (P/N 36825) to
Mount the absorber valves (8) and (9). To the O-ring (3).
help assemble the valves use the tool (11).
Place the other filter on top of the sodasorb
Mount the APL valve (5) (Press firmly until (or similar) and mount the lid of the absorber
the lock »clicks«). (2), including the O-ring (3).
Fit the membrane (4) into the housing and In order to achieve optimum performance of the
mount the cover (3). absorber, knock it gently against a firm surface
(see the fig. below).
Mount the bellows (2).
The circle can now be mounted onto the
Mount the bottle (1). SIESTA i TS machine.
qusjob42.absorber1.pdf
qusjob42.11042.pdf
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Do not add components to the system without making sure they are clean and
in good condition.
Do not use the system before a performance and leakage test has been carried out.
qusjob42.11042.pdf
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qusjob42.11960serviceparts.png
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9. Technical Data
Note:
All flow and volume measurements are related to STPD conditions
(Standard Temperature Pressure Dry).
9.1 General
Dimensions:
Height : 1510 mm
Width : 760 mm (including IBS)
Depth : 670 mm
Weight: : Approx. 140 kg (depending on configuration)
Electrical:
Class :I
Type :B
Mains voltage : 100/115/230 volt 50/60 Hz.
Power consumption (typical) : 130 VA + 20 VA (multigas module)
Battery capacity : 1.5 Ah (ventilator), 5.2 Ah (EGM and
multigas module)
Battery operation time : Approx. 30 minutes
Battery type : NiCd rechargeable (ventilator), sealed Pb
(EGM and multigas module)
Charge time : Approx. 12 hour
Note:
There are no changes in performance when the machine is battery powered.
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9.2 Gases
Note:
All gases and anaesthetic agents must conform to the European Pharmacopeia.
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O2 flush flow:
Fixed flow : Approx. 45 L/min
9.4 Ventilator
Driving gas (AIR or O2):
Pressure : Min. 3.0 (x100kPa) at 80 L/min.
Max. consumption (peak flow) : 120 L/min
Average consumption : Max. 80 L/min at 2.8 (x100kPa)
Pressure range:
Pressure limitation (Plim max) : 90 (x100Pa) (mechanical pressure limitation valve)
Max. adjustable working pressure : 80 (x 100Pa)
High pressure alarm : 10 to 80 (x100Pa)
Min. expiration pressure (Plim min) : +1 (x100Pa)
Cycling pressure : 1 to 80 (x100Pa)
Note:
Negative airway pressures are possible if the patient is breathing spontaneously only.
Set parameters
Tidal Volume : 20 to 1500 ml.
Accuracy : 20 to 250 ml: +/-10%, min. 10 ml
: 250 to 1500 ml: +/-5%, min. 25 ml
Minute volume : 0.2 to 60 L/min.
Frequency : 4 to 80 resp./min.
Accuracy : +/- 5 %
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Note:
The sigh function is only active in VCV and SIMV mode only.
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Water trap:
Capacity : 22 ml.
Measured parameters:
Insp. O2 : 0 to 100 %. Resolution: 1 %
Exp. O2 : 0 to 100 %. Resolution: 1 %
Insp. N2O : 0 to 100 %. Resolution: 1 %
Exp. N2O : 0 to 100 %. Resolution: 1 %
Insp. CO2 : 0 to 10 %. Resolution: 0.1 %
Exp. CO2 : 0 to 10 %. Resolution: 0.1 %
Insp AA : HAL, ENF, ISO: 0 to 7.5 %
SEV: 0 to 9 %
DES: 0 to 20 %
Resolution: 0.1 %
Exp. AA : HAL, ENF, ISO: 0 to 7.5 %
SEV: 0 to 9 %
DES: 0 to 20 %
Resolution: 0.1 %
Resp. rate : 0 to 100 breaths pr. min.
Ethanol : 0.0 to 0.15 %
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Calculated parameters:
MAC : 0 to 10. Resolution: 0.1
Cross-gas interference:
The multigas module will meet the specifications for accuracy, when the individual gases
are within the ranges specified in »measured parameters«.
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Metered dosed inhaler : CFC propellants such as CFC 11, 12 and 114 will have no
propellants effect on the multigas-measurements.
HFA-134a propellant can affect the measurement of
Enflurane, Halothane and Ethanol.
If this is the case the multigas module will give an alarm.
Note:
If the Ethanol concentration or the Acetone concentration is higher than
0.1 %, the accuracy of the gas measurements may be affected.
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For example:
Primary anaesthetic agent is 2.0 % Halothane.
The required Enflurane concentration to identify it as secondary agent is:
0.20 % ENF + 0.05x2 % = 0.30 % Enflurane.
Alarms:
Insp. O2 % high : 18 to 100 % and OFF. Resolution: 1 %
Insp. O2 % low : 18 to 100 %. Resolution: 1 %
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9.7 Environment
Storage temperature : -20 to + 50OC (optional O2-sensor: 0OC to +50OC)
Working temperature : 15 to 35OC
Relative humidity : 10 to 90% RH (non condensing)
Storage pressure : 630 to 1060 (x 100Pa)
Working pressure : 960 to 1060 (x 100 Pa)
9.8 Standards
Standards fulfilled:
Software : EN 60601-1-4
EMC : EN 55011; Group 1; Class B
Electrical safety : EN 60601-1
Function safety : EN 738-1, EN 739, EN 740, EN 837,
EN 980, EN 1281-1
Oxygen monitor (optional) : EN 12218, EN 12598, EN 13220
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Agent Name and Address:
10650E-90 April 08