Siesta I TS Version 3.2
Siesta I TS Version 3.2
Siesta I TS Version 3.2
SIESTA i TS
Anaesthesia Machine
Software Version 3.2
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 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 . . . . . . . . . . . . . . . . . . . . . . . 1-5
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
4.3 Operation of Electronic Gas Mixer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
4.4 Operation of Stopwatch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
4.5 Operation of Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
IV Dameca
User Manual for SIESTA i TS
1. Introduction
This manual is related to EGM software O An APL (Adjustable Pressure Limiting) valve
version 3.2, ventilator software version is integrated into the IBS, giving the user
2.2 and multigas module (optional) software a choice between manual ventilation or
version B7 / 1.6.1.0 or higher. spontaneous breathing.
Dameca anaesthesia machine model SIESTA i O 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 Two types of multigas modules are available
gas supply system or from cylinders. There is (see section 5.2).
no difference in performance when supplied
from cylinders. The electronic gas mixer, ventilator and optional
gas module are all microprocessor controlled,
with software installed.
The machine is equipped with:
The machine can be equipped with various
O An electronic gas mixer (EGM) giving user additional equipment such as:
selectable gas mixes (O2/N2O or O2/AIR) in O Active scavenging system
a range of 0 – 20 L/MIN. If N2O is selected O Transfusion stand
as a mix to O2, the N2O percentage is O Arm for patient monitor
limited to max.75% (minimum 25% O2). O Pin-index reduction valves for 4 L. gas
A real time clock and a stopwatch is cylinders, or stand for 10 L. gas cylinders.
included in the electronic gas mixer. The design of the machine is very flexible towards
mounting of extra equipment and additional rails,
O A microprocessor controlled anaesthesia clamps etc. can easily be mounted on the machine.
ventilator with user selectable ventilation
modes: 1.1 Intended Use
- VCV Volume Controlled Ventilation
The SIESTA i TS anaesthesia machine is inten-
- PCV Pressure Controlled Ventilation
ded for composition of anaesthetic breathing gas
- SIMV Synchronised Intermittent
and manual or automatic ventilation of patients
Mandatory Ventilation
undergoing anaesthesia.
- PSV Pressure Supported Ventilation The SIESTA i TS anaesthesia machine is
- PRVT Pressure Regulated Volume Target intended for adult and paediatric patients.
Qualified anaesthesia personnel should operate
O An integrated breathing system (IBS) the SIESTA i TS anaesthesia machine only.
where Bag in Bottle and patient re-breathing Before operating the machine mains electrical
system (incl. absorber) are integrated into power and pressurised gas must be connected
one block. Thereby there are only 2 tubes to the machine.
(inspiratory and expiratory) from the IBS
system to the Y-piece. The machine is not MRI compatible.
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). The mul-
through the Bag in Bottle system, placed in tigas module has automatic identification of AA.
the integrated breathing system (IBS).
The ventilator continuously measures airway Option: The multigas module can detect if
pressure and inspired/expired volume (optional). Ethanol or Acetone is expired by the
If a multigas module is not installed, the ventila- patient, and measure the concentration.
tor can also measure inspired O2 by means of a
fuel cell sensor (optional) placed on the inspira- If a secondary AA is present, the multigas
tory port of the patient breathing system. module also identifies this, and measures the
concentration.
The integrated breathing system (IBS) of the
SIESTA i TS is a semi-closed patient breathing When gas sample has been measured by the
system with one-way valves in both the inspira- multigas module, it is re-introduced to the pati-
tory and expiratory limb, and an absorber for ent breathing system, on the expiratory side.
eliminating CO2. The system is suitable for high
flow (app. the patient minute volume), medium The multigas module does not require
flow (app. 1-1.5 L/min) and low flow (app. re-calibration.
0.5-1 L/min) of freshgas for patient ventilation.
The 3 pcs. integrated power outlets (optional)
The IBS is a combination of a Bag in Bottle unit of the Siesta i TS are separated from the mains
and a patient re-breathing circuit. The IBS has power by a transformer. This transformer supplies
a standing bellows in order for the user to see isolated power to the power outlets. See section
the controlled ventilation of the patient by the 9 regarding power rating for 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
1-4 Dameca
User Manual for SIESTA i TS
Dameca 1-5
User Manual for SIESTA i TS
Flow Diagram
qusjob42.Siesta i TS flowdiagram.wmf
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User Manual for SIESTA i TS
2. Safety Precautions
Read this manual carefully and familiarize O 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.
O 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 O 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.
O 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 O 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
O A patient monitor connected to the patient O 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
O 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.
O Do not add, remove or modify any part of O 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.
O No oil or grease should be used in this
machine. This also applies to silicone O 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.
O The machine is not suitable for use in the O 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 O When operating the machine, an alternative
or similar standards must be used. oxygen supply must always be present.
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User Manual for SIESTA i TS
O 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.
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User Manual for SIESTA i TS
O Vaporizers should be serviced according O 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.
O 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.
O Use only original DAMECA O-rings; O 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
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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
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User Manual for SIESTA i TS
5 6 7 8 9
Resp. meas.
hPa Adult sensor At Y-piece Peak Alarm
17 30
8.0
13
40 MVexp(l) 5.8 4.0
menu
Plateau
20
17 Exp
TV(ml) 480
Flow (L/min) PEEP Cancel 14
O2 N2O 3
1 0
OFF
alarms
1.00 2.00 Compl. 34 ml/hPa RR(1/min) 12 4
15
TV set RR set I:E PEEP P Insp Vent. mode Status
(ml) (1/min) Ratio (hPa) (hPa)
PSV settings 16
500 12 1:2 OFF (17) VCV VENT
25 24 23 22 21 20 19 17
qusjob42.Fig. 3-3 with gasmodule vers 3,2.pdf
1. Window for set freshgas flow 13. Window for activating alarm menu
2. Window for measured freshgas flow 14. Window for activating »cancel alarms«
3. Window for set O2 percentage in 15. Window for measurement of respiration
freshgas flow data (optional)
4. Window for set total freshgas flow 16. Window for machine status VENT/
5. Window for alarms and messages MANUAL/STBY)
6. Window for date and real time 17. Window for ventilation mode
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, pressure
12. Window for activating trend menu measurements and high alarm setting.
Dameca 3-3
User Manual for SIESTA i TS
5 6 7 8 9
40 Peak menu
11
17 30
Trend
12
2 Plateau menu
17
20 Resp. meas.
Alarm
8.0
13
PEEP
MVexp(l) 5.8 4.0
menu
3 Exp
24 23 22 21 20 19 17
qusjob42.fig. 3-4 without gasmodule vers 3,2.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 19. Window for PSV settings
8. Window for measurement of inspired (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
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Dameca 3-5
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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
O Set the freshgas switch (24 on fig. 3-1) to shown on the display:
»Circle System«.
»Patientsystem disconnected«.
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qusjob42.10653ny.pdf
4-2 Dameca
User Manual for SIESTA i TS
PUSH "CLICK"
Remove seal
on new absorber.
(disposable ver.)
qusjob42.11960uds ab.pdf
1. Take the handle of the absorber. O 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. O 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.
(5 on fig. 3-1)
qusjob42.10653ny.pdf
Dameca 4-3
User Manual for SIESTA i TS
Note: Caution:
When the freshgas switch is set to If the ventilator is in automatic
»Aux Outlet«, a message will be shown ventilation mode, when the freshgas
on the display: »External freshgasoutlet switch is set to »Aux Outlet«, the
activated«. In this situation the patient ventilator will stop and an alarm
can only be ventilated manually, as the will start: »Ventilator stopped due to
ventilator cannot be activated. external freshgasoutlet activated«.
If the user tries to activate the ventilator,
a message will be shown on the display:
»Cannot start ventilator when external
freshgasoutlet is activated«.
The machine can be installed with 2 different types of multigas modules, each with different kind of
water trap.
Gasmodule B Adult:
41200-10 (10 pcs.) 200ml/min. 10ml 1 month
Neonate:
41200-11 (10 pcs.) 70ml/min. 6ml 1 month
Gasmodule A Gasmodule B
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User Manual for SIESTA i TS
Note:
In order to assure correct measurement of gases, the water trap must be
replaced after the max. stated lifetime.
Attach a sample tube between the water trap and In the service menu a super-user or a technician
the Y-piece, for example via a bacteria filter. can define the default value for placement of the
flow sensor.
The sample tube must be 2 to 3 metres long and
have an internal diameter of at least 1.2 mm. In the spirometry-menu the user can change the
placement of the flow sensor.
Dameca sample tube P/N 42630-100 (100 pcs.,
2m) or P/N 42630-200 (100 pcs., 3m) can be However the machine will always go back to
used. default value, after selftest or when the machine
is powered off.
4.1.5 Patient volume sensor If the flow sensor is placed at the Y-piece, be
The machine can be set up with volume monitor sure to place the sensor with the PATIENT
(15 on fig. 3-3 or 15 on fig. 3-4), which uses a port facing the patient.
flow sensor.
2-35 L/min.). 40
Plateau
17
Adult flow sensor is used for patients with tidal
20
PEEP
volume from 200 to 1500 ml (insp./exp. flow 0
3
10-120 L/min.). Compl. 34 ml/hPa
Dameca 4-5
User Manual for SIESTA i TS
O 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.
O If the external flow sensor is used, tubings between flow sensor and connectors (7 on fig. 3-2)
on the machine must be connected.
2 4
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.
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User Manual for SIESTA i TS
If an integrated gas module is not installed, the O 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:
32
Setup
menu
qusjob41.10967-85.pdf
Dameca 4-7
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-
O 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.
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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 »If you want to leave this test, press
tidal volume delivered to the patient normal screen«
in VCV or SIMV mode may not 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.
Set the APL valve in patient breathing system
Note: (9 on fig. 3-1) to 35 hPa, and open the vaporizer.
If the FULL selftest has been bypassed, Press the control wheel to confirm.
the text »SELFTEST BYPASSED«
is shown constantly on the main display. Display: »Electronic gas mixer test is running«
Warning:
The FULL selftest must be carried Note:
out at least one time per day, when If the machine is setup with a separate
the machine is in use. patient monitoring device with measure-
ment of gas concentrations, and the
sample flow is not returned to the
patient system, the tube for sample flow
must not be connected to the patient
Warning: system during the test. Otherwise the
The patient must not be connected to leakage will be too high.
the machine during the FULL selftest.
3. Filling of BAG
1. System and valves Display: »Leakage test of system is running«
Display: »System check running«
The electronic gas mixer generates a flow
The internal safety system of the machine of 10 L/min O2 and 9.75 L/min AIR for
(watchdog) and the valves for the electronic 10 seconds to fill the respiration bag.
gasmixer and the valves for the ventilator After this, the airway pressure in the patient
are checked during this. system is checked (should be 25 to 45 hPa).
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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.
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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« O The APL valve should be adjusted as
desired by the user.
When the control wheel is pressed, the leakage O Y-piece should be removed from the testadapter
test for the BAG/VENT valve and the expiration O 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.
O 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 O 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.
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During the LC selftest the compliance of the O 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- O By selecting Y the LC selftest is bypassed.
tegrated breathing system incl. hoses and Y-piece. O 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 O 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. O Press enter on the control wheel to activate
the Carrier gas setting.
O Turn the control wheel to the desired carrier
gas, and press enter on the control wheel to
confirm the new setting.
Note: O 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. O 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:
3 Stop watch
Normal
ed 00:00:00
screen
Gas meas. (%)
O Start the stopwatch by pressing the O Reset the stopwatch by pressing the
»stopwatch« field. »stopwatch« field twice (double-click).
This can only be done when the stopwatch
O 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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Resp. meas.
hPa Adult sensor At Y-piece Peak Alarm
17 30
8.0
40 MVexp(l) 5.8 4.0
menu
Plateau
20
17 Exp
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 »VENT«. This inspiratory flow is adjusted continuously
by the ventilator in order to reach the set
A. Ventilation mode inspiratory pressure and hold this pressure du-
During automatic ventilation the following ring the inspiration phase, independent of sy-
ventilation modes are available: stem compliance and actual freshgas flow.
VCV (Volume Controlled Ventilation) If the set inspiratory pressure is not reached
PCV (Pressure Controlled Ventilation) during inspiration, the ventilator generates a
SIMV (Synchronized Intermittent Mandatory PRESSURE LIMIT alarm (see section 7.3.8).
Ventilation) (optional)
PSV (Pressure Supported Ventilation) In SIMV mode the patient can trigger a VCV
PRVT (Pressure Regulated Volume Target) 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. inspiratory pressure automatically from breath to
(if flow sensor is »Adult«) or 1.5 sec. breath, in order to deliver the set tidal volume to
(if flow sensor is »Paed.«) the patient.
The ventilator will change the inspiratory
3. The patient inspiratory flow at the Y-piece pressure automatically, until the difference
(measured by the flow sensor) is lower than between the set tidal volume and the expired
the set »Exp. trig«. tidal volume (measured by the flow sensor in
The »Exp. trig.« is set as a % of the measured the patient circuit) is less than 10 %
peak flow during inspiration.
When PRVT mode is selected, the inspiratory
Ventilation backup: flow for the first 3 inspirations will be as in VCV
If the patient does not trigger an inspiration mode with a 20 % inspiratory pause, in order to
before the »PSV backup« period has ended, a determine the patient compliance. The patient
»PSV BACKUP MODE ACTIVATED, compliance is used to calculate the inspiratory
SWITCHING TO PCV« alarm starts (see section pressure which is necessary to deliver the set
7.3.14) and the ventilator automatically switches tidal volume.
to PCV mode.
For the 4.inspiration the inspiratory flow will be
The alarm disappears when the »cancel alarms« as in PCV mode and the inspiratory pressure will
button is pressed. be based upon the set tidal volume and the
measurement of the patient compliance.
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less than 5 hPa from the alarm limit for high Press the Vent. mode field and select the desired
airway pressure, then the inspiratory pressure mode with the control wheel (17 on fig. 3-1).
will be limited to high airway pressure alarm Press the control wheel to confirm the selected
limit - 5 hPa and an alarm starts; REQUIRED mode. The ventilation mode will not change
INSP. PRESSURE TOO CLOSE TO HIGH until the control wheel is pressed.
PRESS. ALARM (see section 7)
B. Tidal volume/Minute volume (active in
If the desired inspiratory pressure is not reached VCV or SIMV mode only)
during inspiration, a PRESSURE LIMIT alarm The tidal volume/minute volume delivered
starts (see section 7) by the ventilator in VCV or SIMV mode is
automatically compensated for the compliance
of the breathing system and for the freshgas
Caution: flow.
If the expired tidal volume measured
during PRVT ventilation is too low TV,patient = TV,ventilator + TV,freshgas -
compared with the set tidal volume, the TV,compliance
ventilator will automatically increase
the inspiratory pressure until 5 hPa During automatic ventilation in VCV or SIMV
from the high airway pressure alarm li- the ventilator automatically calculates the
mit. Therefore it is especially important correct inspiratory flow to give the patient the
in PRVT mode that the alarm limit for desired tidal volume/minute volume, indepen-
high airway pressure is set to a value dent of other ventilator settings (respiration
that is suitable for the patient. rate, I:E ratio, inspiratory pause etc.) and of
the compliance and freshgas flow.
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Example on min. inspiratory flow: The ventilator controls the inspiratory flow
Tidal volume = 20ml, I:E = 1:2, Insp. pause = 0 in order to reach this pressure during start
These settings give a min. respiration rate of 34. of inspiration.
Example on max. inspiratory flow: When the set inspiratory pressure above PEEP
Respiration rate = 20, I:E = 1:2, Insp. pause = 0 is reached, the ventilator makes a pressure
These settings give a max. tidal volume of 1330ml. plateau until the expiration phase.
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Press the P insp. field and select the desired Press the control wheel to confirm the selected
inspiratory pressure with the control wheel expiratory trigger flow.
(17 on fig. 3-1). The expiratory trigger flow will not change until
Press the control wheel to confirm the selected the control wheel is pressed.
inspiratory pressure.
Support Pressure
The inspiratory pressure will not change until The inspiratory pressure above PEEP applied to
the control wheel is pressed. the patient in PSV mode.
G. PSV settings The support pressure will not change until the
If the machine is set up with PSV, the patient control wheel is pressed.
can control the inspiration and expiration of the
ventilator, via the following settings. H. High alarm
Press the number shown to the right of the value
Inspiratory trigger flow for measured PEAK pressure.
The inspiratory flow the patient must apply, in
order for the ventilator to start an inspiration. Resp. meas.
Peak
Press the Insp. trig. field and select the desired 17 30
8.0
inspiratory trigger flow with the control wheel MVexp(l) 5.8 4.0
(17 on fig. 3-1). Plateau
Press the control wheel to confirm the selected 17 Exp
inspiratory trigger flow.
PEEP TV(ml) 480
The inspiratory trigger flow will not change un- 3
til the control wheel is pressed.
Expiratory trigger flow Adjust the high alarm setting by turning the
The inspiratory flow measured during inspira- control wheel, and confirm by pressing the
tion, at which the ventilator will stop inspiration control wheel.
and go to expiration.
The expiratory trigger flow is a percentage of The new alarm limit will not be effective until
the PEAK flow measured during inspiration. the control wheel is pressed.
Press the Exp. trig. field and select the desired In PCV mode the high alarm will automatically
expiratory trigger flow percentage with the be set 10 hPa higher than Inspiratory Pressure +
control wheel (17 on fig. 3-1). PEEP.
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In PSV mode the high alarm will automatically Press the »Setup menu« field (11 on fig. 3-3)
be set 10 hPa higher than support pressure + and select »Vent. settings« in order to open the
PEEP. menu, and get access to the following settings:
If the measured airway pressure during auto- Inspiratory pause (active in VCV and
matic ventilation is higher than the high alarm SIMV mode only)
limit, the ventilator will immediately go into The percentage of the inspiratory time, in which
expiration state, and the alarm will start. the inspiratory flow is closed in VCV or SIMV
mode.
I. More ventilator settings The SIMV trigger point will not change until
The secondary ventilator settings are placed in the control wheel is pressed.
a menu.
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The PSV backup period will not change until The sigh functionality is activated only if
the control wheel is pressed. activate is set to Y.
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Note: Note:
If the freshgas flow is set to 0.0 L/min The APL valve is for manual
when the automatic ventilation is star- ventilation only.
ted, the electronic gas mixer will auto-
matically start an O2-flow of 300 ml/min.
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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.
In the service menu a super-user or a technician The machine then integrates this real-time
can define the default value for placement of flow during time, in order for the volume
the flow sensor. measurement to be shown on the display.
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Exp Insp
4 Exp CO2 O2 32 33
1.8 N2O 64 63
2 Insp CO2
Resp. meas.
hPa Adult sensor At Y-piece Peak
The multigas module measures the gas concentrations based upon a sample taken from the
Y-piece.
This sample flow is re-introduced to the patient breathing system, on the expiratory side.
Module B with two types of water trap; Adult (sampleflow 200 ml/min.) and
Neonate (sampleflow 70 ml/min.).
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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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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
O Age of Anaesthesia 1996; 76: 179-185
O 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 O 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).
O 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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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,
O Full test only if multigas module is not installed,
O 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:
O Day
Note:
O Month If the full selftest or LC test has been
O Year carried out, or the machine has been
O Hour powered OFF, the settings and data
O Minute will automatically be reset.
O 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
Table A
Time Ventilation Set Tidal Set Resp. rate Set Insp.
mode volume pressure
Table B
Time Meas. Peak Minute Meas. Resp. Expired
pressure Volume Exp rate CO2
Table C
Time Set O2 Set AIR Set N2O Expired
Flow Flow Flow O2
Table D
Time Exp Primary Insp Primary Expired MAC
Agent Agent N2O
Table E
Time Expired Inspired Expired Inspired
O2 O2 CO2 CO2
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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.
O Test type
By selecting reset, the user can reset all the O Test time
trend data. O Leakage in VENT system
O 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, Respiration rate and Apnea sub menu will appear on the display, with the
can be disabled by setting »CO2 alarms« to following settings:
OFF in the alarm menu.
O Insp O2 high O Exp CO2 high
On the display is shown whether the CO2 O Insp O2 low O Exp CO2 low
alarms are set to ON or OFF. O Exp O2 high O Insp AA low
O Exp O2 low O Exp AA low
When status is changed to »STBY« or »VENT«, O Insp N2O high O Insp AA high
»CO2 alarms« are automatically set to ON, O Insp CO2 high O Exp AA high
and the alarm limits for Exp/Insp CO2 and O 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
O Page
set to »OFF« when the anaesthesia
O Print (only if print option is installed)
machine status is set to »STBY« or
O 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- O Patient system disconnected
in alarm system for all the measured parameters, O 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 ventilator:
down« is also shown on the display.
After approx. 20 sec. the machine will automati- O Airway pressure high
cally power off in order not to discharge the O System pressure high
battery completely. O Disconnection
Connect the machine to mains in order for the
O Drivegas low
electronic gasmixer battery to re-charge.
O Ventilator fan stopped
O Ventilator battery low
The machine can be used when the battery has O System pressure
been charged to a safe capacity. O Pressure limit
O Freshgas high
O Insp. O2 % high/low (only if multigas
Note: module is not installed, and O2 monitor
During an »electronic gasmixer battery with external fuel cell sensor is activated
low« alarm, the audible alarm cannot in the service menu)
be disabled. O Expired minute volume high/low (only if
volume sensor is activated in the service menu)
O Ventilator mains power failure
O Measured TV too high
O PSV backup mode activated
7.2.6 External freshgas outlet activated O Required insp. pressure is too low
The »external freshgasoutlet activated« alarm is
O Required insp. pressure is too high
O Required insp. pressure is too close to high
activated if the external freshgasoutlet on the
press. alarm
machine is activated.
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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 functionality can be disabled 7.3.4 Drivegas low
in the service-menu, by a super-user
The »ventilator drivegas low« alarm is activated
or a technician.
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. ventilator is too low to secure proper function
PS: This functionality can be disabled
in the service-menu, by a super-user of the ventilator during a mains power
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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Note:
7.3.15 Required insp. pressure is too low The alarms related to the measured gas
The »Required insp. pressure is too low« alarm concentrations are disabled until a re-
is activated if the inspiratory pressure required spiration rate is detected by the mult-
to reach the set tidal volume in PRVT mode is igas module based upon the measured
less than 4 hPa. CO2 concentrations.
This means that the gas concentration
alarms are not active, until a patient is
7.3.16 Required insp. pressure is too high
connected to the anaesthesia machine
The »Required insp. pressure is too high« alarm and breathing through the patient system.
is activated if the inspiratory pressure required
to reach the set tidal volume in PRVT mode is
more than 67 hPa.
Note:
7.3.17 Required insp. pressure is too When the anaesthesia of a patient has
close to high press. alarm been completed, and the patient is
The alarm »Required insp. pressure is too close disconnected from the machine, select
to high press. alarm« is activated if the inspira- »Reset« in the trend menu (in order to
tory pressure required to reach the set tidal reset all trend data) and the gas concen-
volume in PRVT mode is less than 5 hPa from tration alarms are once again disabled,
the high pressure alarm setting. until a respiration rate has been
detected by the multigas module.
The trend data can also be reset by
7.4 Multigas Module Alarms performing the FULL selftest or the
LC selftest or by selecting »Reset
The following alarms are in relation to the data & settings« in the setup menu.
optional multigas module:
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The »inspired O2 % high« alarm is activated The »inspired AA % low« alarm is activated
if the O2 % measured by the multigas module if the AA % measured by the multigas module
is higher than the alarm limit. is lower than the alarm limit.
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User Manual for SIESTA i TS
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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If this alarm happens, go to setup menu, select Check that the water trap is not filled with
gas meas. setup menu and select »Gasmodule liquid. Replace if necessary.
ini« in order to restart the gas module and
perform a new calibration.
7.5 System Alarms
7.4.13 Ambient CO2 too high The following alarms are in relation to
The gasmodule draws room air into the the system:
measuring chamber at certain intervals, in
order to calibrate the module. O Mains power failure
O Ventilator out of order
However, if the measured CO2 concentration O Gas module error
of the ambient (room) air is too high for the gas- O Machine closing down
module to calibrate, the »ambient CO2 too high«
alarm is given.
7.5.1 Mains power failure
If this alarm happens, increase the ventilation The »mains failure« alarm is activated if the
of the room in which the machine is placed. mains power is lost during use.
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 internal batteries are primarily
intended for alarm back-up.
The machine will work normally
Note: during this period. A »closing down«
When this alarm is active, the accuracy alarm will appear before the machine
of the CO2 measurements may not be closes down in order not to completely
according to specifications. discharge the batteries.
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Note:
If a gasmodule error happens, the
7.5.3 Gas module error gasmodule can be reset by doing the
An alarm is activated if a mal-function, different following:
from the once listed in section 7.4, is detected in Go to setup menu, select gas meas.
the optional multigas module. setup menu and select »Gasmodule ini«
in order to restart the gas module and
There are 5 different types of gasmodule error perform a new calibration.
alarms:
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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.
O Function control
O Integrity control
O 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.
O Remove the bottle (1), and remove bellows (2).
O Remove the cover (3), and remove the
Caution: membrane (4).
O 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- O Remove the caps (6) for the insp/exp valves
chine. Avoid organic fluids as acetone,
(7), and remove the valves.
turpentine, thinner or similar. O Remove absorber valves: Inspiratory valve
(8) marked C and the expiratory valve (9)
marked B. To help disassemble the valves
use the tool (11).
O 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
Dameca 8-3
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O 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:
O Mount the valve caps (6). Sofnolime, Medisorb, Prosorb, Sodalime, Lime-
pak, Agasorb, Sefasorb, Carbolime, Chemosorb,
O 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
O 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
O 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).
O 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).
O Mount the bellows (2).
The circle can now be mounted onto the
O Mount the bottle (1). SIESTA i TS machine.
4 4 3 2
1
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.
4 4 3 2
1
qusjob42.11042.pdf
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8.11 Consumables
Water trap, Adult (10 pcs.) for gasmodule B (lifetime: 1 month) . . . . . . . . . . . . . . . . . . 41200-10
Water trap, Neonate (10 pcs.) for gasmodule B (lifetime: 1 month) . . . . . . . . . . . . . . . . 41200-11
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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. 90 minutes
Battery type : NiMH 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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Ventilation mode (controlled) : VCV, SIMV (option), PCV, PSV (option), PRVT (option)
SIMV settings:
Trigger point : -0,5 to -10.0 (x100Pa)
PSV settings:
Support pressure : 4 to 50 (x100Pa)
Inspiratory trigger : 1 to 10 L/min.
Expiratory trigger : 10 to 80 %
PSV backup : 10 to 40 sec.
Test mode : LC TEST, FULL TEST
Sigh settings:
Interval : 50 to 150 respirations
Added tidal volume : 30 to 80 %
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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Measured parameters:
Calculated parameters:
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Interference [%ABS]
Contaminant
CO2 N2O O2 Agents
< 1 % Acetone 0.1 0.1 0 0
< 1 % Methane 0.1 0.1 0 0
< 0.1 % Ethanol 0 0.1 0 0
< 80 % He Unspecified Unspecified 2.0 Unspecified
< 50 ppm NO Unspecified Unspecified 2.0 Unspecified
< 80 % N2 0 0 0 0
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Alarms:
Insp. O2 % high : 18 to 100 % and OFF. Resolution: 1 %
Insp. O2 % low : 18 to 100 %. Resolution: 1 %
9.8 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)
9.9 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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IF IF
ORIGINAL RED D A M E C A A / S ORIGINAL RED
EMC DECLARATION
Performed by: Henrik Lænø Date : 20060301 Norm: EN 60601-1-2 : 2001
Product name(s) Siesta i TS & Siesta i Whispa (refered as AWS) Class: Not Life supportting
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IF IF
ORIGINAL RED D A M E C A A / S ORIGINAL RED
EMC DECLARATION
Performed by: Henrik Lænø Date : 20060301 Norm: EN 60601-1-2 : 2001
Product name(s) Siesta i TS & Siesta i Whispa (refered as AWS) Class: Not Life supportting
Table 204
Guidance and manufacturer´s declaration – electromagnetic immunity
The AWS is intended for use in the electromagnetic environment specified below. The customer or the user of AWS should
assure that it is used in such an environment.
Immunity test IEC 60601 AWS Electromagnetic environment -guidance
test level Compliance
level
Portable and mobile RF communications equipment should be used no
closer to any part of the AWS, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 10 Vrms d= 0,35¥ P
1EC 61000-4-6 150 kHz to 80
MHz
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IF IF
ORIGINAL RED D A M E C A A / S ORIGINAL RED
EMC DECLARATION
Performed by: Henrik Lænø Date : 20060301 Norm: EN 60601-1-2 : 2001
Product name(s) Siesta i TS & Siesta i Whispa (refered as AWS) Class: Not Life supportting
Table 206
Recommended separation distances between
portable and mobile RF communications equipment and the AWS.
The AWS is intended for use in an electromagnetic environment in which radiated RF-disturbances are controlled. The customer or the user of
the AWS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the AWS as recommended below, according to the maximum power of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum
output power of 150 kHz to 80 MHz 80MHz to 800MHz 800MHz to 2,5 GHz
transmitter
W
d= 0,35¥ P d= 0,35¥ P d= 0,7¥ P
0,01 0,04 0,04 0,07
0,1 0,11 0,11 0,22
1 0,35 0,35 0,70
10 1,11 1,11 2,22
100 3,50 3,50 7,00
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
Warning;
If necessary to place electronic equipment close to AWS, normal operation of AWS should be verified before the AWS is used.
Test Result
The AWS has passed the tests in this declaration without any degradation.
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11-4 Dameca
Agent Name and Address:
10650E-90 September 09