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User Manual
Dameca a/s
Islevdalvej 211
DK-2610 Roedovre, Denmark
Phone: +45 44 50 99 90, Telefax: +45 44 50 99 99E-mail: [email protected], www.dameca.com
SIESTAiTSAnaesthesia Machine
Software Version 3.0
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User Manual for SIESTA i TS
Dameca I
Conformity according to the
Council Directive 93/42EEC
concerning Medical Devices.
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 a/s will repair or replace all defective
components during the period of warranty, pro-
vided (1) that the unit has been used correctly in
accordance with the instructions for use and (2)
that the instructions for maintenance have beenobserved carefully.
Defective products or components must be
returned to DAMECA a/s with a detailed
description of the defect in question.
If repairs are carried out by anyone else than
DAMECA a/s or by a DAMECA a/s appointed
agent, the guarantee no longer applies.
Nobody but DAMECA a/s can issue any otherform for guarantee, either in writing or orally.
DAMECA a/s has no responsibility for any
translation of this English version of the manual.
Preventive maintenance of this unit should
be carried out at least once a year either by
DAMECA a/s or by an authorized technician.
Document No. 10650E-90
April, 2008
User Manual for Anaesthesia Machine
Model SIESTA i TS
Software Version 3.0
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User Manual for SIESTA i TS
II Dameca
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User Manual for SIESTA i TS
Dameca III
Contents
1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11.1 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
2. Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12.2 Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.3 Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
3. Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13.1 Anaesthesia Gas Scavenging System (AGSS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
4. Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1 Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14.2 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15.1 Respiration Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Gas Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
6. User Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16.1 Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2 Trend Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
6.3 Alarm Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
6.4 Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
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User Manual for SIESTA i TS
IV Dameca
Contents (continued)
7. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17.1 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
8. Maintenance and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.1 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.3 IBS Patient Breathing System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.4 CO2 Absorber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.5 Hoses, Y-piece and Manual Breathing Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.6 Cleaning Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
8.7 After Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
8.8 Safety Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
8.9 Parts for the CO2 Absorber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
8.10 Parts for the IBS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
9. Tehcnical Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.2 Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
9.3 Electronic Gas Mixer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
9.4 Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
9.5 Integrated Breathing System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
9.6 Multigas Module (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
9.7 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
9.8 Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
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User Manual for SIESTA i TS
Dameca 1-1
1. Introduction
This manual is related to EGM software
version 3.0, ventilator software version2.0 and multigas module (optional) software
version B7 or higher.
Damecaanaesthesia machine model SIESTAi
TS is applicable with most types of inhalation
anaesthesia. O2 and N2O, or O2 and AIR can
be administered, and anaesthetic vaporizer(s)
is connected to a back-bar.
The gas supply can be obtained from a centralgas supply system or from cylinders. There is
no difference in performance when supplied
from cylinders.
The machine is equipped with:
An electronic gas mixer (EGM) giving user
selectable gas mixes (O2/N2O or O2/AIR) in
a range of 0 20 L/MIN. If N2O is selected
as a mix to O2, the N2O percentage islimited to max.75% (minimum 25% O2).
A real time clock and a stopwatch is
included in the electronic gas mixer.
A microprocessor controlled anaesthesia
ventilator with user selectable ventilation
modes:
- VCV Volume Controlled Ventilation
- PCV Pressure Controlled Ventilation
- SIMV Synchronised Intermittent
Mandatory Ventilation
- PSV Pressure Supported Ventilation
An integrated breathing system (IBS)
where Bag in Bottle and patient re-breathing
system (incl. absorber) are integrated into
one block. Thereby there are only 2 tubes
(inspiratory and expiratory) from the IBS
system to the Y-piece.
An APL (Adjustable Pressure Limiting) valve
is integrated into the IBS, giving the usera choice between manual ventilation or
spontaneous breathing.
A multigas module (optional) which measures
respiration rate and inspired and expired
concentrations of O2 , N2O, CO2 and AA
(anaesthetic agent). The multigas module
has automatic identification of AA, as well as
identification of a secondary AA, if present.
The electronic gas mixer, ventilator and optional
gas module are all microprocessor controlled,
with software installed.
The machine can be equipped with various
additional equipment such as: Active scavenging system Transfusion stand Arm for patient monitor
Pin-index reduction valves for 4 L. gascylinders, or stand for 10 L. gas cylinders.
The design of the machine is very flexible towards
mounting of extra equipment and additional rails,
clamps etc. can easily be mounted on the machine.
1.1 Intended Use
The SIESTA i TS anaesthesia machine is inten-
ded for composition of anaesthetic breathing gas
and manual or automatic ventilation of patients
undergoing anaesthesia.
The SIESTA i TS anaesthesia machine is
intended for adult and paediatric patients.
Qualified anaesthesia personnel should operate
the SIESTA i TS anaesthesia machine only.
Before operating the machine mains electrical
power and pressurised gas must be connected
to the machine.
The machine is not MRI compatible.
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User Manual for SIESTA i TS
1-2 Dameca
1.2 Description
The electronic gas mixer (EGM) of the SIESTA i
TS controls the freshgas flow given to the patientbreathing system. The EGM continuously mea-
sures this flow to assure that it is in accordance
with the setting made by the user.
Besides the EGM controls and displays data
from electronic gas mixer, ventilator and
optional multigas module on its 15 display,
which is touch controlled.
The ventilator of the SIESTA i TS uses
compressed AIR or O2 to ventilate the patientthrough the Bag in Bottle system, placed in
the integrated breathing system (IBS).
The ventilator continuously measures airway
pressure and inspired/expired volume (optional).
If a multigas module is not installed, the ventila-
tor can also measure inspired O2by means of a
fuel cell sensor (optional) placed on the inspira-
tory port of the patient breathing system.
The integrated breathing system (IBS) of theSIESTA i TS is a semi-closed patient breathing
system with one-way valves in both the inspira-
tory and expiratory limb, and an absorber for
eliminating CO2. The system is suitable for high
flow (app. the patient minute volume), medium
flow (app. 1-1.5 L/min) and low flow (app.
0.5-1 L/min) of freshgas for patient ventilation.
The IBS is a combination of a Bag in Bottle unit
and a patient re-breathing circuit. The IBS has
a standing bellows in order for the user to see
the controlled ventilation of the patient by the
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
by the position of the bellows.
Integrated into the IBS is an APL valve which
is used for manual ventilation only.
The IBS uses a CO2 absorber i-SORB which
contains 900 gr. Sodalime. The absorber isavailable as a re-usable or a disposable version.
If the absorber is disconnected from the IBS,
two valves automatically close the connections
to the absorber, in order not to loose gases.
The multigas module (optional) of the SIESTA i
TS uses a gas sample from the Y-piece to mea-
sure inspired and expired concentrations of O2 ,
N2O, CO2 and AA (anaesthetic agent). Besides,the multigas module can detect if Ethanol or
Acetone is expired by the patient, and measure
the concentration. The multigas module has
automatic identification of AA.
If a secondary AA is present, the multigas
module also identifies this, and measures the
concentration.
When gas sample has been measured by themultigas module, it is re-introduced to the pati-
ent breathing system, on the expiratory side.
The multigas module does not require re-cali-
bration, as the calibration is stable for life-time.
The 3 pcs. integrated power outlets (optional)
of the Siesta i TS are separated from the mains
power by a transformer. This transformer
supplies isolated power to the power outlets.
See section 9 regarding power rating for the
power outlets.
Note:The parts of the SIESTA i TS do notcontain any latex.
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User Manual for SIESTA i TS
Dameca 1-3
1.3 Performance
The electronic gas mixer of the SIESTA i TS is
designed to give a freshgas mixture selected bythe user of:
0 to 20 L/min O2 / N2O (O2 0-10 L/min,
N2O 0-10 L/min)
or 0 to 20 L/min O2 / AIR (O2 0-10 L/min,
AIR 0-10 L/min)
This flow is led through the vaporizer rail,
where anaesthetic agent can be added by meansof a user selectable vaporizer.
By activating an oxygen by-pass valve, approx.
45 L/min of O2 will be added to the freshgas
flow, after the vaporizer rail.
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).
The ventilator of the SIESTA i TS is designed
to give an inspiratory flow of:
Continous flow: 2 to 80 L/min Max. Peak flow: 120 L/min.
In VCV and SIMV mode the Tidal volume,Resp. rate, I:E ratio and Insp. pause user settings
are continuously controlled by the ventilator in
order to stay within the 2 to 80 L/min continuous
flow limits.
Inspiratory flow = Tidal volume x Resp. rate x
((I+E)/I) x (100/(100-Insp. pause))
The integrated breathing system (IBS) of the
SIESTA i TS has an expiratory and inspiratoryresistance of:
60 L/min 30 L/min 5 L/min
Expiratory 4.5 2.0 0.3
resistance (x100Pa) (x100Pa) (x100Pa)
Inspiratory 4.5 2.0 0.3
resistance (x100Pa) (x100Pa) (x100Pa)
Compliance = 4 ml/hPa with adult tubings
(22mm diameter).
The CO2 absorber i-SORB of the integrated
breathing system (IBS) is designed to optimize
the flow through the absorber, so that all of the
sodalime is being used.
qusjob8.absorberkurver.tif
Note:
The SIESTA i TS contains batteries thatmust be exchanged by a technician atcertain intervals, as prescribed in theservice manual.
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User Manual for SIESTA i TS
1-4 Dameca
1.4 User Setup
The SIESTA i TS can be set up to match user
preferences.
The following features can be installed when
the machine is manufactured:
Integrated patient suction Auxiliary freshgas outlet and integrated
auxiliary O2 flowmeter Multigas module 3 pcs. integrated power outlets
Extra O2 , AIR or VAC gas outlet 1 or 2 pcs. pin-index yokes for 4 L. gas cy-
linders or stand for 2 pcs. 10 L. gas cylinders Power unit for AGSS PSV accessible or not
The following parameters can be changed
after the machine has been manufactured:
Ventilator volume setting based on Tidal
volume or minute volume. SIMV accessible or not. If multigas module is not installed, oxygen
monitor based on external fuel cell sensor
can be activated or de-activated. Volume monitor can be activated or
de-activated.
If volume monitor is activated, the volume
measurement can be configured in two ways:
Only expired volume
If the volume monitor is configured to only
exp. volume, the volume sensor must be placed
at the expiratory port of the patient breathing
system. The volume monitor will then measure
the expired tidal- and minute-volume only.
Full spirometry
If the volume monitor is configured to full
spirometry, the volume sensor must be placed
at the Y-piece of the patient breathing system.
The volume monitor will then measure expiredtidal- and minute volume, inspired tidal volume
(during manual ventilation) and a pressure/
volume graph (spirometry loop) can be selected
by the user.
All these settings can be changed in the service-
menu, by a super-user or a technician.
1.5 Responsibility of the
Manufacturer
Dameca a/s is responsible for the effects on
safety, reliability and performance of the
equipment only if:
Personnel authorized by Dameca a/s
carry out assembly, operations, extensions,
re-adjustments, modifications, periodical
service or repairs.
The pneumatic installation of the relevant
rooms complies with appropriate requirements.
The equipment is used in accordance with
this user manual.
1.6 Safety Features of the SIESTAiTS Anasthesia Machine
Gas supply
O2, AIR and N2O supply failure alarm. Built-in
check valves to prevent reverse flow of gases.
The ventilator, patient suction (optional) and
AGSS power unit (optional) is powered by the
primary driving gas (AIR or O2 , normally AIR).
The optional patient suction can also be
powered by VAC (option).
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User Manual for SIESTA i TS
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If the primary driving gas pressure is lost, a
driving gas valve automatically switches tothe secondary driving gas source (AIR or O2 ,
normally O2)
Electronic gas mixer
N2O cut-off if O2 supply fails.
Electronic O2/N2O ratio control (secures a
minimum of 25% O2 in an O2/N2O mix).
An MPL (Maximum Pressure Limiting) valveopens if the pressure of the freshgas flow to the
auxiliary freshgas outlet exceeds 90 (x100Pa).
Vaporizer rail
Back-bar for one or two vaporizers. The back-bar for two vaporizers is fitted with interlock
system to assure that only one vaporizer can
be activated one at a time.
Ventilator
A high-pressure alarm will automatically force
the ventilator into its expiratory state, avoiding
dangerous overpressure situations.
In addition the ventilator has a built-in pressurerelief valve which opens at 90 (x100Pa).
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Flow Diagram
qusjob42.SI1LW6~1.wmf
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User Manual for SIESTA i TS
Dameca 2-1
2. Safety Precautions
Read this manual carefully and familiarizeyourself with the machine before you start
to operate the machine.
Always check the machine for proper function
before use.
A WARNING indicates a situation in which
the user or the patient may be in danger of
injury.
A CAUTION indicates a situation that may
lead to equipment damage or malfunction.
A NOTE indicates a point of particular interest
for more efficient and convenient operation.
2.1 Warnings
Do not open service hatches or covers. Nouser-serviceable parts inside the machine.
A qualified service technician should
perform service.
The machine must be connected to correct
grounded hospital grade electrical outlets
only.
Always unplug the electric power cord
before cleaning or maintenance of the
machine. Let it dry completely before
reconnecting it to the electrical outlet.
Spillage of liquids may cause electrical
shock.
Check that all cables are in good working
condition before connecting the machine
to mains or patient.
Do not use this machine in an environmentexceeding the EMC levels in EN60601-1-1-2.
External patient breathing systems used
with this machine must conform to EN740
or similar standard.
Bacterial filters used with this machine must
conform to EN 13328-1 or similar standard.
An anaesthetic vapour delivery deviceconnected to the machine shall comply
with ISO8835-4 or similar standard.
Heat and moisture exchangers used with this
machine must conform to EN ISO 9360 or
similar standard.
Humidifiers used with this machine must
conform to EN ISO 8185 or similar standard.
Suction units used with this machine
must conform to EN ISO 10079-1,
EN ISO 10079-2 and EN ISO 10079-3
or similar standard.
Medical gases and anaesthetic agents used
with this machine must conform to the
European pharmacopoeia.
Central gas supply used with this machine
must comply with EN737-1 or ISO7396 or
similar standard.
Note:If the central gas supply fails, theauxiliary gas outlet (optional) ofthis machine will also fail.
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A patient monitor connected to the patient
breathing system, may cause a leakage,
even if it is in stand-by mode.
The AGSS must be turned on whenever the
machine is in use.
Do not add, remove or modify any part of
the machine, unless authorised by Dameca a/s.
Explosion hazard
No oil or grease should be used in this
machine. This also applies to siliconebased lubricants and inflammable oil or
grease. Only PTFE based oxygen
compatible lubricants must be used,
(e.g. DAMECA special grease P/N 36825).
The machine is not suitable for use in the
presence of flammable anaesthetic agents
such as ether and cyclopropane. Only
anaesthetic agents complying with EN 740
or similar standards must be used.
Patient safety
Do not use the machine for a clinical
procedure without first ensuring that the
complete system is operating correctly.
If the multigas module of the Siesta i TS
is not installed, the machine should always
be used with a separate monitor for O2,
anaesthetic agent and CO2 concentrations.
This monitor must comply with the relevant
standards under the EU Medical Device
Directive.
If the volume monitor of the Siesta i TS is
not installed, the machine should always
be used with a separate monitor for expired
volume. This monitor must comply with
the relevant standards or the EU Medical
Device Directive
Ensure that all connections are secure and
check for proper operation of the machine
before use. In particular the patient breathing
system and O-rings should be checked toensure that connections are not loose, and
the patient breathing circuit is not leaking.
The use of antistatic or electrically condu-
ctive breathing tubes when utilizing high
frequency surgery equipment may cause
burns and is therefore not recommended
in any application of this machine.
Constant attention by a qualified individualis required whenever a patient is under
anaesthesia or connected to a ventilator.
Some malfunction of equipment requires
immediate action.
When using the ventilator, alternative means
for ventilating the patient must be present.
When operating the machine, an alternative
oxygen supply must always be present.
Use only the anaesthetic agent for which
the vaporizer is calibrated. Using the wrong
agent in the vaporizer can be fatal for patients.
If a re-usable CO2 absorber is used, the
following must be taken into account during
change of soda-lime: Soda-lime dust is
caustic and can produce burns in the respira-
tory tract if inhaled. Breathing protection
must be used to ensure that no soda-lime
dust is inhaled by personnel or patient.
Do not start any test procedure of the
electronic gas mixer or the ventilator with
a patient connected to the machine.
The test procedures are designed to ensure
correct and safe function of the machine.
Do not bypass the test procedures unless
patient safety requires an immediate starting
up procedure.
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Dameca 2-3
Note:The auxiliary O2 flowmeter (optional)
is by-passing the MPL valve. The pres-sure from the flowmeter may exceedthe pressure from the freshgas outlet.
hetic gases in operating rooms. Observe
that the ball of the flowmarker is visible.
2.2 Cautions
Before connecting the power cord to the
electrical power supply outlet check that the
local voltage and frequency are as stated on
the TYPE label on the rear of the machine.
Do not attempt to connect other cables or
connectors to the auxiliary power outlets
(optional), than the ones intended for thispurpose.
Maximum load on side rails at table is
20 kg. Too much heavy equipment attached
at one side of the machine may cause the
machine to tilt.
Maximum total load on table plate
(including side rails) is 40 kg.
Maximum load on top plate is 40 kg.
Maximum torque on siderails is 20 Nm.
When closing the drawers of the machine,
observe that nothing gets squeezed or
damaged, with special attention to fingers.
Vaporizers used for Fluothane, Halothane or
other anaesthetic agents containing Tymol or
other stabilisers must be emptied every other
week, and the agent that is drained must be
destroyed.
Check calibration of vaporizers regularly
using a proper gas indicator (e.g.refracto-
meter or similar).
Authorised service personnel should service
this machine at least once a year.
Failure of operation
If the machine fails to respond as described,
do not use until qualified service personnel
have corrected the situation.
Occupational hazard
Do not use this machine in insufficiently
ventilated areas. Use scavenging system to
avoid increased concentrations of anaest-
The O2percentage in the patient circuit may
differ significantly from the O2percentage
of the freshgas.
When using soda lime in absorbers, follow
the manufacturers instructions.
If the machine has been used with different
anaesthetic agents, residues of these agents
(PPM) may still remain in the machine
(vaporizer rail etc.). By setting a high
freshgas flow during a long period of
time these residues can be minimized.
Means to avoid cross infection between
patients must be used. See section 8
regarding maintenance and cleaning.
When connecting more than one external
equipment to the auxiliary power outlets
(optional), a high leakage current from one
equipment (f.ex. in case of a defective earth
conductor) will affect the leakage current
from the other equipment.
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2.3 Symbols
Type B (EN60601-1) protection
against electrical shock.
Attention, consult accompanying
documents.
Adjusment for auxiliary O2 or
patient suction:
Turn counter-clockwise to increase.
Turn clockwise to decrease.
ON/OFF switch for lamp.
Protective earth.
Equipotentiality.
ON/OFF
WEEE Symbol, meaning that the
electronics must not be regarded
as normal waste.
Note:Tubings used with this product must fulfill the EN12342 standard, andrespiration bags must fulfill the EN1820 standard.
Vaporizers should be serviced according
to the manufacturers instructions by an
authorised service centre.
Use only original DAMECA hoses and
accessories; other hoses and accessories
may cause malfunctions.
Use only original DAMECA O-rings;
other O-rings may cause problems if they
are not of the same size or material.
Do not leave spare cylinder valves open
when using the machine on central gas
outlets.
Pressure from cylinders may be higher than
the pressure from central outlets, and the
cylinder supply could be depleted.
Disconnect the machine from mains and
medical gas supply, when not in use, to
prevent pollution.
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User Manual for SIESTA i TS
DamecaDameca 3-1
3. Function
Fig. 3-1 Anaesthesia machine model SIESTA iTS front view
1. Castors with brake
2. Drawers
3. AGSS ON/OFF (option) and flow marker
4. Auxiliary oxygen flowmeter outlet
(optional)
5. Auxiliary freshgas outlet (optional)
6. CO2 absorber
7. Lock for absorber
8. BAG connection
9. APL valve (for manual ventilation only)
10. Bellows
11. O2
flush
12. Water trap for multigas module (optional)
13. Transfusion stand (optional)
14. Top shelf
15. Main switch
16. 15 TFT colour touch screen
17. Control wheel
18. ON/OFF switch for light
19. Emergency flow switch
20. Back-bar for two interlock vaporizers
21. Integrated auxiliary oxygen flowmeter
(optional)
22. Table with integrated rails
23. Integrated patient suction (optional)
24. Auxiliary freshgas outlet switch (optional)
qusjob42.10653 front.png
5
10
2
1
1215
17
22
20
1
13
24
11
8
6
14
16
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7
9
21
23
1819
IBS
4
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Fig. 3-2 Anaesthesia machine model SIESTA i TS rear view
1. Castors without brake
2. Lower fan
3. Yokes for spare cylinders (optional)
4. Grounding point
5. Mains power inlet switch
6. Mains power cord
7. Connections for patient flow sensor
(optional)
8. Auxiliary gas outlet (optional)
9. Auxiliary AGSS connection
10. RS232 port
11. Auxiliary power outlets (optional)
12. Upper fan
13. Gas inlets
14. Insp./Exp. connections for patient
breathing system
15. Lock for patient breathing system
16. Patient suction connection (optional)
17. Connection for optional O2 fuel cell
sensor
qusjob42.10653 bag.png
11
2
13
10
1 1
7
15
14
16
12
65
4
3
8
9
17
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Fig. 3-3 Main display if multigas module is installed
Flow (L/min)O2 N2O
1.00 2.00
Rotameter
Freshgas flow(L/min)
3.00
O2set %
33
Adult sensor At Y-piece Peak
17
Plateau
17
PEEP
3
Compl. 34 ml/hPa
hPa
0
20
40
%
0
2
4
Stop watch
00:00:00
Cancel
alarms
Alarm
menu
Trend
menu
Setup
menu
Normal
screen
Vent. mode
VCV
Status
VENT
Exp CO2
1.8Insp CO2
0.1
Resp. meas.
MVexp(l)5.8
Exp
TV(ml) 480
RR(1/min)12
8.04.0
OFF4
Gas meas. (%)
Exp Insp
O2 32 33
N2O64 63
SEV0.4 0.6
MAC 0.4(age: 40)
PSV settings
30
TV set(ml)
500
RR set(1/min)
12
PEEP(hPa)
OFF
I:ERatio
1:2
P Insp(hPa)
(17) More settings
EGM 5.0 Thursday 6. December 11:13
Touch screen controlled Selftest bypassed
qusjob42.Fig. 3-3 with gasmodule.pdf
1. Window for set freshgas flow
2. Window for measured freshgas flow
3. Window for set O2 percentage in
freshgas flow
4. Window for set total freshgas flow
5. Window for alarms and messages
6. Window for date and real time
7. Window for measurement of CO2concentrations
8. Window for measurement of gas
concentrations
9. Window for stopwatch
10. Window for activating normal screen
11. Window for activating setup menu
12. Window for activating trend menu
13. Window for activating alarm menu
14. Window for activating cancel alarms
15. Window for measurement of respiration
data (optional)
16. Window for machine status VENT/
MANUAL/STBY)
17. Window for ventilation mode
18. Window for more ventilator settings
19. Window for PSV settings (optional)
20. Window for set inspiratory pressure
21. Window for set PEEP
22. Window for set I:E ratio
23. Window for set respiration rate
24. Window for set tidal volume
25. Window for respiratory graph,
pressure measurements and
high alarm setting.
13
6
23
4
3
2
1
5 7 98
10
11
12
14
15
22 21 20 19 1824 17
16
25
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Fig. 3-4 Main display if multigas module is not installed
1. Window for set freshgas flow
2. Window for measured freshgas flow
3. Window for set O2 percentage in
freshgas flow
4. Window for set total freshgas flow
5. Window for alarms and messages
6. Window for date and real time
7. Window for respiratory graph, pressure
measurements and high alarm setting
8. Window for measurement of inspired
O2 percentage (optional)
9. Window for stopwatch
10. Window for activating normal screen
11. Window for activating setup menu
12. Window for activating trend menu
13. Window for activating alarm menu
14. Window for activating cancel
alarms
15. Window for measurement of
respiration data (optional)
16. Window for machine status
(VENT/MANUAL/STBY)
17. Window for ventilation mode
18. Window for set inspiratory pause
19. Window for PSV settings (optional)
20. Window for set inspiratory pressure
21. Window for set PEEP
22. Window for set I:E ratio
23. Window for set respiration rate
24. Window for set tidal volume
Flow (L/min)O2 N2O
1.00 2.00
Rotameter
Freshgas flow(L/min)
3.00
O2set %
33
hPa
0
20
40
Stop watch
00:00:00
Cancel
alarms
Alarm
menu
Trend
menu
Setup
menu
Normal
screen
Vent. mode
VCV
Status
VENT
Resp. meas.
MVexp(l)5.8
Exp
TV(ml) 480
8.04.0
PSV settings
30
TV set(ml)
500
RR set(1/min)
12
PEEP(hPa)
OFF
I:ERatio
1:2
P Insp(hPa)
(17) More settings
EGM 5.0 Thursday 6. December 11:13
Touch screen controlled Selftest bypassed
O2meas. %
32
Adult sensor At Y-piece
Peak
17
Plateau
17
PEEP
3
Compl. 34 ml/hPa
qusjob42.fig. 3-4 without gasmodule.PDF
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6
23
4
3
2
1
5 7 98
10
11
12
14
15
22 21 20 19 18 17
16
24
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User Manual for SIESTA i TS
DamecaDameca 3-5
3.1 Anaesthesia Gas Scavenging System (AGSS)
The Siesta i TS anaesthesia machine has a
built-in scavenging system. This systemrequires evacuation flow of 30-40 L/min.,
in order to remove excess gases from the
integrated patient breathing system to the
AGSS outlet on the rear of the machine.
The evacuation flow can be generated by the
permanent gas installation in the operating
room, or it can be generated by an air driven
ejector in the Siesta i TS machine, activated
with an ON/OFF switch located at left side ofthe machine, next to the AGSS flow marker.
A built-in reservoir in the scavenging system is
open to the ambient air and serves as a relief ofthe ejector vacuum.
An AGSS connector on the rear of the machine
is for connection of the machine to the central
scavenging system.
Warning:The gases and agents used underanaesthesia can pose a danger ifAGSS is not active, or the operatingroom is not ventilated properly.
Fig. 3-5 Flow marker
The air driven ejector is optional.
An AGSS flowmarker at left side of the
machine contains a yellow ball which is
visible when the flow is 25 L/min or more.
qusjob33.flowmark.pcx
Note:The AGSS flowmarker is for the IBS(Integrated Breathing System) only.If an external breathing system isused, this system must be equippedwith an indicator for the AGSS flow.
3.1.1 External Breathing System
If an external breathing system is used with the
machine (see section 4.1.3), the excess gases
from this system can be removed by connecting
it to the auxiliary AGSS connection on rear sideof the machine (9 on fig. 3-2).
Remove the plug from the auxiliary AGSS
connection (30 mm female cone) and connect
the external breathing system.
Warning:The external breathing system must
have an open reservoir integrated intothe AGSS part of the system.Otherwise the auxiliary AGSS flowcan create a sub-atmospheric pressurein the external breathing system,which can be dangerous to the patient.
When an external breathing system is no longer
used with the machine, re-mount the plug on the
auxiliary AGSS connection (30 mm female cone).
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User Manual for SIESTA i TS
DamecaDameca 4-1
4. Operation
Note:Before using the machine the first timeit must be electrical safety testedaccording to EN 60601-1, and all
patient related parts must be cleaned.
Note:Before connecting the machine to a
patient, a function test must be carriedout as described in section 4.2.
Note:Check voltage rating on the type labelat the rear panel of the machine,
before connecting it to the mains.
4.1 Set Up
Connect the machine to the mains.
Connect the machine to the pressurised
gases (400 - 600 kPa), vacuum (optional)
and AGSS. Activate AGSS flow and check that the yellow
ball in the flow marker (3 on fig. 3-1) appears.
The AGSS flow can be generated by the
machine (optional) or by a unit in the AGSS
installation of the hospital. If the AGSS flow
must be generated by the machine, it can
be activated by pressing the red/green pin
placed above the flow marker (3 on fig. 3-1).
4.1.1 Integrated breathing system
Assemble the integrated breathing system
(see section 8), connect it to the base (1)
and lock it by using the handle (2). Connect i-SORB CO2 absorber (5) to the
integrated breathing system, by placing
it into the bracket underneath the base
and pulling up, until the lock clicks.
Caution:If a disposable i-SORB CO2 absorber is
used with the system, the seal on a newabsorber must be removed, before theabsorber is connected to the integrated
breathing system.
qusjob42.10653-00 slange.pdf
2
1
5
4
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Connect inspiratory and expiratory hoses
(3) to the connections marked INSP and
EXP on the integrated breathing system,
including Y-piece (4) and bacteria filter(P/N 38477). The bacteria filter can be
placed at the Y-piece or at the expiratory
connection of the IBS system. Connect manual respiration bag (6) to the
connection marked BAG on the integrated
breathing system. A hose can be placed
between BAG connection and respiration
bag to give better flexibility for the user.
Note:
If an i-SORB CO2 absorber is notreinserted within 30 sec., a messagewill be shown on the display:Absorber disconnected.
If the ventilator is in automaticventilation mode, this messagewill be followed by an alarm.
21-12-200409:47
qusjob42.10653ny.pdf
Note:The integrated breathing system mustnot be changed during use.
If the integrated breathing system isdisconnected, a message will beshown on the display:
Patientsystem disconnected.
If the ventilator is in automaticventilation mode, this messagewill be followed by an alarm.
Note:The respiration bag must be 1-3 L.otherwise the leakage test of theBAG system, included in the selftest,may not work correctly.
Set the freshgas switch (24 on fig. 3-1) to
Circle System.
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User Manual for SIESTA i TS
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4.1.2 Changing the CO2 absorber
4.1.3 External breathing system
Other breathing systems than the integrated
breathing system can be used with the
Siestai TS anaesthesia machine.
Assemble the breathing system and connect
it to the auxiliary freshgas outlet (optional)
placed at left side of the writing table
(5 on fig. 3-1)
PUSH
Remove sealon new absorber.(disposable ver.)
"CLICK"
qusjob42.11960uds ab.pdf
1. Take the handle of the absorber.
2. Push the knob above the handle of the
absorber to release it. The two absorber
valves will close in order to prevent loss
of gases during change.
3. Lift the used absorber out of the bracket.
4. Put the fresh absorber into the bracket.
5. Lift the handle until the lock gives a click.
6. The absorber is now attached to the patientsystem.
Caution:A bacteria filter should always be usedwith the integrated breathing system.Dameca bacteria filter P/N 38477-50(50 pcs.) can be used.
In order to remove excess gases from the
breathing system, connect it to the to 30 mm
female cone marked AUX AGSS on the
rear of the machine (9 on fig. 3-2).
See section 3.1.1
Set the freshgas switch (24 on fig. 3-1)
to Aux Outlet.
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Caution:If the ventilator is in automaticventilation mode, when the freshgasswitch is set to Aux Outlet, theventilator will stop and an alarmwill start: Ventilator stopped due toexternal freshgasoutlet activated.
4.1.4 Multigas module water trap
If an integrated gas module is installed, the water
trap (12 on fig. 3-1) must be installed prior to use.
Make sure the water trap is not filled with water,
and install it on the base on left side of the machine.
If the water trap is filled with water, it must be
replaced (P/N 41020-25).
The capacity of the water trap is 22 ml.
Attach a sample tube between the water trap and
the Y-piece, for example via a bacteria filter.
The sample tube must be 2 to 3 metres long and
have an internal diameter of at least 1.2 mm.
Dameca sample tube P/N 42630-100 (100 pcs.,
2m) or P/N 42630-200 (100 pcs., 3m) can be
used.
Adult sensor At Y-piece Peak
17
Plateau
17
PEEP
3
Compl. 34 ml/hPa
hPa
0
20
40
30
PEEP(hPa)
I:ERatio
P Insp(hPa)
Note:
When the freshgas switch is set toAux Outlet, a message will beshown on the display: Externalfreshgasoutlet activated. In thissituation the patient can only beventilated manually, as the ventilatorcannot be 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.
4.1.5 Patient volume sensor
The machine can be set up with volume monitor
(15 on fig. 3-3 or 15 on fig. 3-4), which uses a
flow sensor.
The machine uses two different flow sensors:
Paediatric flow sensor is used for patients with
tidal volume from 20 to 300 ml (insp./exp. flow
2-35 L/min.).
Adult flow sensor is used for patients with tidal
volume from 200 to 1500 ml (insp./exp. flow
10-120 L/min.).
If the flow sensor is placed on the expiratory
side, the expired tidal volume and minute
volume are measured.
If the flow sensor is placed at the Y-piece, the
inspired tidal volume is also measured, and a
spirometry-graph (pressure, volume) can be
shown on the main display.
In the service menu a super-user or a technician
can define the default value for placement of theflow sensor.
In the spirometry-menu the user can change the
placement of the flow sensor. However the ma-
chine will always go back to default value, after
selftest or when the machine is powered off.
If the flow sensor is placed at the Y-piece, be
sure to place the sensor with the PATIENT
port facing the patient.
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External flowsensor kit P/N 10967-120
Item Qty Description Part No.
1 1 Spirometry tube 2 m 42632-091
2 1 Adult flow sensor, Re-usable 42632-06
3 1 Paed. flow sensor, Re-usable 42632-07
4 2 Single-use bacterial filter. 38477
1
42
3
qusjob41.10967-120.pdf
Patient port
Caution:After selftest has been performed, the type of flow sensor (Adult/Paediatric)must be defined in the setup menu.
User Manual for SIESTA i TS
Dameca 4-5
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.
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4.1.6 O2 fuel cell sensor
If an integrated gas module is not installed, the
machine can be set up with an O2 monitor (8 onfig. 3-4), which uses an external fuel cell sensor.
Then the main display will look like the
following:
Place the O2 sensor on T-piece
(P/N 42012-07) in the patientbreathing system on the inspiratory
side. The O2 sensor must always face
upwards.
Connect cable between O2 sensor and
connector (17 on fig. 3-2) on rear panel
of the machine.
User Manual for SIESTA i TS
4-6 Dameca
Stop watch
00:00:00
Setup
menu
Normal
screen
:13
ed
O2meas. %
32
O2 Sensor kit P/N 10967-85
Item Qty Description Part No.1 1 T-piece 42012-07
2 1 Oxygen sensor 42035-46
3 1 Cable for oxygen sensor 10967-86
2
1
3
qusjob41.10967-85.pdf
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User Manual for SIESTA i TS
Dameca 4-7
4.2 Function Test
Turn on the mains power inlet switch on
rear side of the machine (5 on fig. 3-2).
If the main switch on front of the machine is set
to ON during this period, the message will dis-
appear and the machine will continue to function.
If the main switch on front of the machine is NOT
set to ON position during this period, the ma-
chine will power off when the period has ended.Note:When the mains power switch onrear side of the machine is turnedon, the batteries inside the machinewill be charged at all times, inde-
pendent of whether the machine isrunning or not. Therefore this switchshould be set to ON at all times.
Push the main switch on front of the machine
(15 on fig. 3-1) to set it to ON position.
Note:If a mains failure alarm is givenwhen the main switch on front ofthe machine is set to ON position,this is most likely caused by themains power inlet switch on rear sideof the machine not being set to ON.
Note:
When the main switch on front ofthe machine at a later time is pushedin order to set it to OFF position, amessage will be shown on the screen:Machine closing down. Press ma-ins switch to cancel. Now a powerdelay period of app. 20 seconds isstarted. During this the machinewill continue to function as before.
Note:The integrated breathing system must
be assembled and connected, incl. hoses,Y-piece and i-SORB CO
2
absorber, be-
fore a function test can be carried out.
Warning:The patient must not be connected tothe machine at power-up or duringthe functional test.
Now the machine will power up and perform an
initial self-test checking the internal system for
safe condition and performing test sequence 1.
This takes approx. 1 minute.
Note:
If the machine is equipped with an inte-grated multigas module, this modulewill not be working until approx. 2 min.after activating the main switch on front
panel. If the machine is equipped withan O2 monitor which uses an external
fuel cell sensor, this monitor will not beworking until approx. 1 minute afteractivating the main switch on front panel.
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When the initial self-test has been successfully
completed, the machine is in Stand-by mode
and the full selftest can be performed.
4.2.1 FULL self test
During the FULL selftest the machine checks
its functions, measures the compliance of the
system and checks for leakages. The compliance
and leakage test includes the integrated breathing
system incl. hoses and Y-piece.
When the mains switch (15 on fig. 3-1) is set to
ON by the user, the machine automaticallyperforms test sequence 1 to ensure the correct
function of its mandatory components. Then test
sequence 2 is activated.
Test sequences:
Start-up
Display: Do you want to perform FULLTEST: Y/N
Patient must NOT be connected
during test
Select Y or N and press to continue
Change between Y and Nby turning the
control wheel, and press enter to select. By selecting Y the FULL selftest is started.
By selecting N the FULL selftest is bypas-
sed. This should only be done in case of anemergency.
Even if the FULL selftest has been started, the
user can bypass the test by pressing the normal
screen field (10 on fig. 3-3), and the following
text will be shown:
Display: Do you want to bypass selftest:
Y/N
Only bypass in case of anemergency
Select Y or N and press to continue
Change between Y and Nby turning the
control wheel, and press enter to select. By selecting Y the FULL selftest is bypas-
sed. This should only be done in case of
an emergency. By selecting N the FULL selftest is started
again from the beginning.
Warning:If the FULL selftest is bypassed, someof the functions of the machine willnot be checked. The user must thenincrease observation of the patientduring anaesthesia, in order to
maintain a safe function.
Note:During the full selftest all alarmsare disabled.
Note:If a system related alarm (see section 7)is detected after power-up of themachine, the selftest is not started.Instead the alarm is shown on thedisplay. When the alarm is no longeractive, press cancel alarms and theselftest will start.
When FULL TEST is selected by the user
(by selecting FULL TEST in the selftest
menu, included in the setup menu, and pressing
the control wheel), start-up sequence is
activated before going to test sequence 1.
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Warning:
If the FULL selftest is bypassed, thecompliance and leakage of the integra-ted breathing system are not measured.The ventilator therefore uses the datafrom last selftest, and therefore the settidal volume in VCV mode might not
be correct.
Note:If the FULL selftest has been bypassed,the text SELFTEST BYPASSEDis shown constantly on the main display.
Warning:The patient must not be connected tothe machine during the FULL selftest.
2. Gasmixer test
Display: Occlude Y-piece (use testadapter).
Check gas evacuation (flow marker)Set APL valve to 35 hPa
Open vaporizer
Press to start
If you want to leave this test, press
normal screen
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
(9 on fig. 3-1) to 35 hPa, and open the vaporizer.
Press the control wheel to confirm.
Display: Electronic gas mixer test is running
The functionality of the electronic gasmixer
is checked.
Warning:
The FULL selftest must be carriedout at least one time per day, whenthe machine is in use.
1. System and valves
Display: System check running
The internal safety system of the machine
(watchdog) and the valves for the electronic
gasmixer and the valves for the ventilator
are checked during this.
Note:If the machine is setup with a separate
patient monitoring device with measure-ment of gas concentrations, and thesample flow is not returned to the
patient system, the tube for sample flowmust not be connected to the patientsystem during the test. Otherwise theleakage will be too high.
3. Filling of BAG
Display: Leakage test of system is running
The electronic gas mixer generates a flow
of 10 L/min O2 and 9.75 L/min AIR for
10 seconds to fill the respiration bag.
After this, the airway pressure in the patient
system is checked (should be 25 to 45 hPa).
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4. Compliance and leakage, VENT
Display: Leakage test of system is running
The electronic gas mixer generates a flow of
10 L/min O2 and 9.75 L/min AIR for 10 seconds
to fill the bag in the Bag in Bottle system.
After this the electronic gas mixer generates
a flow of 5 L/min O2 and the pressure in the
patient system is checked (should be 1.5 to
4.5 hPa due to Bag in Bottle).
Then the compliance of the VENT system ismeasured, based upon the volume required from
the ventilator to reach a 30 hPa pressure
in the patient system.
This 30 hPa pressure must be reached within
10 sec. at an inspiratory flow of 5 L/min., or an
error message will be shown on main display.
The compliance of the system must be from
2.0 to 10.0 ml/hPa, or an error message willbe shown on main display.
When the 30 hPa pressure is reached, the
leakage of the VENT system is measured, based
upon the pressure drop during time, taking into
account the compliance of the system.
If the pressure drops too fast for the leakage to
be measured, an error message will be shown on
main display:
Display: Leakage too high
Check BiB, connectors and hoses
Press to repeat test
When the control wheel is pressed, the compli-
ance and leakage test will be performed again.
If the leakage is more than 100 ml/min but
less than 1000 ml/min, an error message will
be shown on main display:
Display: Leakage in VENT system XXX
ml/min. Accept: Y/N
Check BiB, connectors and hoses
Select N to repeat test. Select Y tocontinue
Change between Y and Nby turning the
control wheel and press enter to select. By selecting Y the measured leakage is
accepted, and the next test sequence will
be performed. By selecting N the measured leakage is not
accepted, and the compliance and leakage
test will be performed again.
If the leakage is more than 1000 ml/min, an
error message will be shown on main display:
Display: Leakage in VENT system XXX
ml/min.
Check BiB, connectors and hoses
Press to repeat test
When the control wheel is pressed, the compli-ance and leakage test will be performed again.
5. Leakage, BAG
The BAG/VENT valve in the integrated
breathing system is set to BAG and the
pressure in the patient system is measured
to detect possible leakage from the APL valve
or the respiration bag. If the pressure has
dropped to a value below 10 hPa, an error
message will be shown on main display:
Display: Leakage in BAG system too high
(pressure below 10 hPa)
Check APL valve and resp. bag
(empty ?)
Press to repeat test
When the control wheel is pressed, the compli-
ance and leakage test will be performed again.
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6. Leakage, BAG/VENT, exp. valve
and peep valve
Display: Set APL valve at pat. circuit toSP. Close vaporizer
Press to continue
Set the APL valve to SP and close the vaporizer.
Press the control wheel to confirm.
Display: Valve check running
When a 30 hPa pressure is reached on the
outside of the bellows of the Bag in Bottle,with the BAG/VENT valve in BAG position,
the leakage from the BAG/VENT valve and
from the expiration and peep valves inside the
ventilator is checked based upon the pressure
drop during time.
If the pressure drop is too high the ventilator
gives an error message:
Display: Leakage in BiB system too highCheck BiB and change-over valve
Press to repeat test
When the control wheel is pressed, the leakage
test for the BAG/VENT valve and the expiration
and peep valves inside the ventilator will be
performed again.
7. Test completedDisplay: Leakage in VENT system: XXX
ml/min
Compliance in VENT system: X.X
ml/hPa
Press to continue
When the control wheel is pressed, the next text
appears on the display:
Display: Refreshing gases in patient system
The electronic gasmixer generates a flow of 10L/min O2 and 9.75 L/min. AIR for 10 seconds to
remove any anaesthetic agent from the patient system.
Then the nex text appears on the display.
Display: Check alarm sound present
Press cancel alarms to confirm
Check that the alarm sound is present, and press
cancel alarms. Then the next text appears onthe display:
Display: Test completed. Check pat.
suction, vaporizer etc.
Adjust APL valve
Remove Y-piece from test adapter
If vol. monitor is installed, sensor
must be connected and defined
Read user manual
Press to finalize
The APL valve should be adjusted as
desired by the user. Y-piece should be removed from the testadapter If the machine is set-up with volume monitor,
the type of sensor (Adult or Paediatric) must
be defined in the setup menu by the user. When the control wheel is pressed, the
machine goes to STBY mode and all user
settings are set to default values. Then the manual part of the selftest should
be performed, as described in section 4.2.3 to
4.2.15
4.2.2 LC self test
The LC (Leakage and Compliance) test can be used
for measuring compliance and checking for leak-
age if parts of the patient system (f. ex. hoses and
respiration bag) have been changed between two
patients.
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During the LC selftest the compliance of the
system is measured, and the leakage is checked.
The compliance and leakage test includes the in-
tegrated breathing system incl. hoses and Y-piece.
When LC TEST is selected by the user (by
selecting LC TEST in the selftest menu,
included in the setup menu, and pressing the
control wheel), the following test sequences
are activated.
Change between Y and N by turning the
control wheel, and press enter to select. By selecting Y the LC selftest is bypassed.
By selecting N the LC selftest is startedagain, from the beginning.
Note:During the LC selftest all alarmsare disabled.
Test sequences:
Start-up
Display: Do you want to perform LC TEST:
Y/N
Patient must NOT be connectedduring test
Select Y or N and press to continue
Change between Y and Nby turning the
control wheel, and press enter to select. By selecting Y the LC selftest is started. By selecting N the LC selftest is bypassed.
Even if the FULL selftest has been started, the
user can bypass the test by pressing the normal
screen field (10 on fig. 3-3), and the following
text will be shown:
Display: Do you want to bypass selftest:
Y/N
Only bypass in case of an
emergency
Select Y or N and press to
continue
Warning:If parts of the patient system have
been changed and the LC selftest is notperformed, the compliance and leakageof the integrated breathing system arenot measured. The ventilator thereforeuses the data from last selftest, andtherefore the set tidal volume in VCVmode might not be correct.
Note:If the LC selftest has been bypassed,the text SELFTEST BYPASSED isshown constantly on the main display.
Warning:The patient must not be connected tothe machine during the LC selftest.
Test sequence 2 to 7 from the FULL selftest
are carried out.
4.2.3 O2 monitor test
4.2.3.1 Fuel cell sensor
If the machine is set up with an O2 monitor
using an external fuel cell sensor (see section
4.1.6), the following test must be carried out:
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1. Set status to MANUAL. Y-piece must be
open to ambient air.
2. Set freshgas flow to 10 L/min AIR, and waituntil O2 % reading on main display is stable.
Check that the reading is 20-22 % O2. If not,
recalibrate the O2-monitor as described in
section 6.1.6.
3. Set freshgas flow to 10 L/min O2, and wait
until O2 % reading on main display is stable.
Check that the reading is 98-102 % O2. If
not, recalibrate the O2-monitor as described
in section 6.1.6.
4.2.3.2 Multigas module
If the machine is set up with an integrated
multigas module, the following test must
be carried out:
1. Set status to MANUAL. Y-piece must be
open to ambient air.
2. Set freshgas flow to 10 L/min AIR, and waituntil O2 % reading on main display is stable.
Check that the reading is 19-23 % O2.
3. Set freshgas flow to 10 L/min O2, and wait
until O2 % reading on main display is stable.
Check that the reading is 97-103 % O2.
4.2.4 Expired minute volume
If the machine is set up with a volume monitor
(see section 4.1.5), the following test must be
carried out:
1. Attach a test lung to the Y-piece and start
the ventilator in VCV mode. Wait approx. 1
minute and read the measured expired minute
volume on main display. Check that thiscorresponds to the set minute volume
(TVset x RRset). Check that the insp. and
exp. valves in the patient system are moving
during inspiration/expiration.
4.2.5 Airway pressure high alarm
1. Attach a test lung to the Y-piece and start the
ventilator. Read PEAK pressure on main
display and set airway pressure high alarmlimit 5 hPa below PEAK pressure.
Check that the airway pressure high alarm
starts and that the PEAK pressure is now
reduced by the new airway pressure high
alarm limit. Set the airway pressure high
alarm limit as before (above PEAK pressure)
and check that the alarm stops.
4.2.6 Mains failure alarm1. Attach a test lung to the Y-piece and start the
ventilator. Disconnect mains cable to the
machine from the mains outlet. Check that
the mains failure alarm starts, and that the
machine continues to function. Re-connect
mains cable.
4.2.7 O2 flush
1. Set status to MANUAL. Occlude the
Y-piece. Press O2 flush and check that
the respiration bag is quickly filled.
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4.2.8 O2 alarm
1. Set freshgas flow 1 L/min O2 and 1 L/min
N2O. Disconnect O2 gas supply to the ma-chine from the gas outlet and wait until the
O2 flow column on main display goes to zero.
Check that the O2 supply pressure is low
alarm is active, and check that the N2O flow
column is also zero. Re-connect O2 gas supply.
4.2.9 Spare cylinder test
If the machine is equipped with spare cylindersfor O2 or N2O, the following test must be
performed:
1. Disconnect the central gas supply tubings
for O2 and N2O.
2. Open the valves of the spare O2 and N2O
cylinders.
3. Set the Carrier gas in the setup-menu to N2O.
4. Set Total freshgas flow to 0.0 L/min.
5. Read the pressure on the spare cylinder
pressure regulator gauges on rear side
of the machine.
6. Check for sufficient cylinder pressure
(the pressure of the cylinders must never
be below 10 bar).
7. Close the spare cylinder valves.
8. Observe the pressure gauges for at least
one minute. The pressure must not
decrease.
9. Reconnect the central supply tubings to the
central gas supply.
4.2.10 Patient suction test
If the machine is equipped with a patient suction
unit, the user must check the functionality ofthis unit by the following procedure:
1. Fully open the regulator on the suction unit.
2. Remove the plastic tubing from the suction
container and block the tube opening.
3. Start suction by activating the ON/OFF switch.
4. Verify that the vacuum gauge indicates avacuum of at least -0.7 kPa.
5. Adjust the desired vacuum by means of the
regulator knob.
6. Close the ON/OFF switch.
7. Re-mount the plastic tubing on the suction
container.
4.2.11 Vaporizer test
The user must check the functionality of the
vaporizer(s) by the following procedure:
1. Verify that the required vaporizer(s) is
connected.
2. Check that the regulator knob on the vapori-
zer(s) turns freely in the entire regulation
area and is locked in the 0 position.
3. Verify that the vaporizer is sufficiently filled.
Note:Consult the vaporizer user manual.
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4.2.12 Aux. O2
flowmeter test
If the machine is equipped with an auxiliary O2
flowmeter unit, the user must check the functio-nality of this unit by the following procedure:
1. Open the flow meter regulator (turn it
counter-clockwise).
2. Check that the flow can reach 10 ltr/min.
3. Close the regulator (turn it clockwise)
and check there is no flow.
4.2.13 Test of internal switches
1. Remove the CO2 absorber and check the
following message appears on the display
(after app. 30 sec.):
Display: Absorber disconnected
Re-mount the CO2 absorber and check the
message disappears.
2. Remove the integrated breathing system
(unlock handle) and check the following
message appears on the display:
Display: Patientsystem disconnected
Re-mount the integrated breathing system and
check the message disappears.
3. Activate the emergency freshgas switch and
check the following message appears on the
display:
Display: Emergency O2 flow activated
App. 5 L/min. added to the O2flow setting
De-activate the switch and check the message
disappears.
4. If the machine is equipped with an auxiliary
freshgas outlet, activate the switch and check
the following message appears on the display:
Display: External freshgasoutlet activated
De-activate the switch and check the messagedisappears.
4.2.14 Daily check completed
1. Set status to STBY.
2. Go to Alarm menu and select Alarm log
and then Reset.
3. Go to Alarm menu and select Set todefault.
4. Press Cancel alarms to remove old
alarm text from the display.
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Caution:When the function test has been
completed, check that the alarm settingsare suitable for the patient, beforeconnecting the patient to the machine.
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Turning the control wheel counter-clockwisewill decrease the flow.
Turning it clockwise will increase the flow.
The flow is changed immediately as the user
changes the set-flow by turning the control-
wheel.
2. Setting the O2percentage (3), or the total
flow (4), by pressing the appropriate field
on the main display.
Then the value is highlighted (blue) and
the gasflow can be changed by turning the
control-wheel.
Turning the control wheel counter-clockwise
will decrease the flow.
Turning it clockwise will increase the flow.
The flow is NOT changed, before enter is
pressed on the control-wheel.
The freshgas flow values (1), (3) and (4) on
main display are all set values.
The freshgas flow bargraphs (2) on main display
are all measured values.
If the set values and the measured values do not
match over a certain period of time, the machine
will generate an alarm.
If an oxygen flow less than 300 ml/min is set, a
message O2 flow critical low is displayed in
the alarm and message field (5 on fig. 3-3).
This message can be deleted by pressing
cancel alarms.
Flow (L/min)O2 N2O
1.00 2.00
Rotameter
Freshgas flow(L/min)
3.00
O2set %
33
4
3
2
1
4.3 Operation of Electronic GasMixer
When the selftest is completed the electronicgas mixer (EGM) is ready for use.
4.3.1 Setting of freshgas flow
The freshgas flow can be set in two ways:
1. Setting the flow for each gas, by pressing the
set-flow value (1) on the main display. Then
the value is highlighted (blue) and the speci-
fic gasflow can be changed by turning the
control-wheel.
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4.3.2 Changing carrier gas
If the machine is set up with both AIR andN2O as carrier gas for O2, this carrier gas
can be changed in the setup menu.
Press the setup menu field (11 on fig. 3-3)
and the first line of the menu will say
Carrier gas. 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. The gas flow beside the O2-flow will now
change to the selected carrier gas. Besides
the carrier gas flow will change to the last
known flow setting for this specific gas. Leave the menu by pressing the normal
screen field.
Note:The O2percentage is a calculated
value based upon the measured flowdata, and not a value measured by an
oxygen analyser. In case of a hospitalpipeline cross connection, incorrectvalues will result.
The O2percentage in the patient
breathing system may differ signifi-cantly from the O2percentage of
the freshgas.
Note:If the O2, AIR or N2O driving gas
pressure is lower than 2,5 (x100 kPa)the appropriate alarm is activated.
Note:
The displayed values are basedon STPD conditions (StandardTemperature Pressure Dry).
Note:The N2O supply is cut-off in case ofan oxygen failure. When reducing theO2 flow, the N2O flow will be reduced
proportionally, securing a minimumof 25% O2 in the freshgas. N2O will
be cut of at an O2 flow less than100 ml/min.
Note:The freshgas flow can not be activatedif the machine status is STBY. Changeto MANUAL or VENT in order toopen freshgas flow.
If the total flow setting or the O2 set percentage
is changed in such a way that the O2, AIR or
N2O flow becomes less than 100 ml/min, this
flow will automatically be set to 0 L/min,and the O2 set percentage will be changed
accordingly.
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4.3.3 Electronic gas mixer default settings
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:
Parameter Factory set value Limits
Freshgas flow 0.0 L/min 0.0, 0.3-10.0 L/min
O2 set % 100% Carrier gas AIR: 21-100%
Carrier gas N2O: 25-100%
O2-flow 0.0 L/min 0.0, 0.3-10.0 L/min
AIR-flow 0.0 L/min 0.0, 0.1-10.0 L/min
N2O-flow 0.0 L/min 0.0, 0.1-10.0 L/minCarrier gas AIR AIR, N2O
4.4 Operation of stopwatch
Stop watch
00:00:00
Normal
screenGas meas. (%)
3
d
Start the stopwatch by pressing the
stopwatch field.
The colour of the HH:MM:SS will change
from grey to green and the stopwatch will
start to count.
Stop the stopwatch by pressing the
stopwatch field again, and the HH:MM:SS
will change from green to grey and the
stopwatch will stop counting.
Reset the stopwatch by pressing the
stopwatch field twice (double-click).
This can only be done when the stopwatch
is stopped.
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4.5 Operation of Ventilator
Flow (L/min)O2 N2O
1.00 2.00
Adult sensor At Y-piece Peak
17
Plateau
17
PEEP
3
Compl. 34 ml/hPa
hPa
0
20
40
Cancel
alarms
Alarm
menu
Vent. mode
VCV
Status
VENT
Resp. meas.
MVexp(l)5.8
Exp
TV(ml) 480
RR(1/min)12
8.04.0
OFF4
PSV settings
30
TV set
(ml)
500
RR set
(1/min)
12
PEEP
(hPa)
OFF
I:E
Ratio
1:2
P Insp
(hPa)
(17) More settings
When the selftest is completed the machine is
in stand-by mode, ready for automatic ventilation
after adjustment of the ventilation parameters.
The following parameters can be set when the
machine status is STBY, MANUAL orVENT.
A. Ventilation mode
During automatic ventilation the following
ventilation modes are available:
VCV (Volume Controlled Ventilation)
PCV (Pressure Controlled Ventilation)
SIMV (Synchronized Intermittent Mandatory
Ventilation) (optional)
PSV (Pressure Supported Ventilation)
In VCV mode the set tidal volume is delivered
to the patient during inspiration by a constant
inspiratory flow.
This inspiratory flow is adjusted continously
by the ventilator in order to deliver the set
tidal volume to the patient, independent of
system compliance and actual freshgas flow.
VCV is also known as CMV or IMV.
In PCV mode the set inspiratory pressure above
PEEP is applied to the patient during inspira-
tion, by a decelerating inspiratory flow.
This inspiratory flow is adjusted continuouslyby the ventilator in order to reach the set
inspiratory pressure and hold this pressure du-
ring the inspiration phase, independent of sy-
stem compliance and actual freshgas flow.
If the set inspiratory pressure is not reached
during inspiration, the ventilator generates a
PRESSURE LIMIT alarm (see section 7.3.8).
In SIMV mode the patient can trigger a VCV
inspiration during the expiration phase by
applying a decrease of the airway pressure in
the patient system. In the ventilator settings
menu the user can define at which decrease
of the airway pressure a VCV inspiration
should be triggered. The decrease of the airway
pressure is relative to the set PEEP. If the patient
has not triggered an inspiration during the
expiration phase, the ventilator automatically
gives a VCV inspiration.
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The time where the patient can trigger an inspi-
ration is called trigger-window. This trigger-
window is calculated when the mode is changed
to SIMV and is equal to the cycle time (inspira-tion + expiration) of the previous mode. When
the set resp. rate in SIMV is decreased, to force
the patient to start spontaneous breathing
during wake-up, the trigger-window is kept
at the end of the expiration phase, see picturebelow:
Triggering is never possible during
insp.time + 200msec.
Time, pressure graph in SIMV mode.
For security reasons the patient can never
trigger a new inspiration, when the ventilator
is already performing an inspiration, and just
after an inspiration has taken place.
Therefore the trigger-window is limited, so
that it can never enter the inspiration-time
plus a 200 msec. period thereafter
The patient can only trigger one inspiration in
each trigger window.
In SIMV mode the tidal volume and inspiration
time should be the same as it was in VCV mode,
even when the user prolongs the expiration
time to force the patient to start spontaneous
breathing during wake-up.
Therefore the setting of inspiration time and
volume is different in SIMV mode.
Inspiration time:
The inspiration time in SIMV mode is shown
beneath the I:E ratio setting.
If the Resp. rate, or Insp. pause is changed, the
ventilator automatically calculates a new
I:E ratio, in order to keep the inspiration
time the same.
Example:
Default settings and Resp.rate is set to 20.
This gives an inspiration time of 1 sec.
If SIMV mode is selected and the resp.rate is
then set to 10 (in order to increase expiration
time in SIMV), the I:E ratio is automatically
changed from 1:2 to 1:5, in order to keep the
inspiration time at 1 sec.
Trigger-window: triggering po ssible
Time, pressure graph in previous mode.
Time, pressure graph in SIMV mode.
Trigger-window: triggering possible
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In SIMV mode the I:E ratio can go from 1:1
to 1:9.9, since inverse I:E ratio is not allowed
in SIMV mode. Therefore Resp. rate and Insp.
pause cannot be adjusted to a setting whichgives an I:E ratio outside the 1:1 to 1:9.9
Example:
Default settings and resp.rate is set to 20.
This gives an inspiration time of 1 sec.
If SIMV mode is selected, the resp.rate can
be set from 6 resp/min (gives I:E ratio of 1:9.0)
to 30 resp/min (gives I:E ratio of 1:1).
If the user wants to change the inspiration timein 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
the display. However, this new setting will not
be effective until the control wheel is pressed.
Set volume:
If the ventilator is installed with Minute
volume as set volume, the tidal volume in
SIMV mode is shown beneath the MV setsetting.
If the Resp. rate is changed, the ventilator
automatically calculates a new minute volume
setting in order to keep the tidal volume the
same.
Example:
Default settings and Resp. rate is set to 20.
This gives a tidal volume of 300 ml.
If SIMV mode is selected, and the resp.rate
is then set to 10 (in order to increase expiration
time in SIMV), the set minute volume is
automatically changed from 6.0 to 3.0, in
order to keep the tidal volume at 300 ml.
If the user wants to change the tidal volume in
SIMV mode, select MV set and adjust with
the control wheel. When the set minute volume
is adjusted, the new tidal volume is shown onthe display. However this new setting will not
be effective until the control wheel is pressed.
Note:In the service-menu it can be definedwhether SIMV mode shall be availableor not. This definition can be changed
by a super-user or a technician.
In PSV mode it is only the patient who controls
the ventilator, as the ventilator does not give any
mandatory inspirations to the patient. Therefore
this mode is for patient with a certain degree of
spontaneous respiration, where the ventilator
assists the respiration of the patient.
Inspiration:
When the patient starts an inspiration, and the
inspiratory flow at the Y-piece (measured by the
flow sensor) is higher than the set Insp. trig.,
the ventilator starts an inspiration, to reach the
set Support pressure.
When this support pressure is reached, the
ventilator maintains the pressure in the rest of
the inspiration phase.
Expiration:
The inspiration stops and the expiration starts if
one of the following conditions are met:
1. The pressure reaches the high alarm
(same as for the other ventilation modes).
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2. The inspiration time is more than 2.5 sec.
(if flow sensor is Adult) or 1.5 sec.
(if flow sensor is Paed.)
3. The patient inspiratory flow at the Y-piece
(measured by the flow sensor) is lower than
the set Exp. trig.
The Exp. trig. is set as a % of the measured
peak flow during inspiration.
Ventilation backup:
If the patient does not trigger an inspiration
before the PSV backup period has ended, a
PSV BACKUP MODE ACTIVATED,SWITCHING TO PCV alarm starts (see section
7.3.14) and the ventilator automatically switches
to PCV mode.
The alarm disappears when the cancel alarms
button is pressed.
B. Tidal volume/Minute volume (active in
VCV or SIMV mode only)
The tidal volume/minute volume delivered
by the ventilator in VCV or SIMV mode isautomatically compensated for the compliance
of the breathing system and for the f