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Siesta I TS Version 3.2

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User Manual

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

User Manual for Anaesthesia Machine


Model SIESTA i TS
Software Version 3.2

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 been
observed 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 other


form 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.
Conformity according to the
Council Directive 93/42EEC Document No. 10650E-90
concerning Medical Devices. September, 2009

Dameca I
User Manual for SIESTA i TS

Left blank intentionally

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

2. Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1


2.1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.3 Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

3. Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.1 Anaesthesia Gas Scavenging System (AGSS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

4. Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1 Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Function Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
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

6. User Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1


6.1 Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2 Trend Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
6.3 Alarm Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
6.4 Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15

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

8. Maintenance and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1


8.1 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.2 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
8.11 Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8

9. Tehcnical Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1


9.1 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 Type A (see section 5.2) (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
9.7 Multigas Module Type B (see section 5.2) (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
9.8 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
9.9 Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12

10. Alphabetical Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

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.

1-2 Dameca
User Manual for SIESTA i TS

O Continous flow: 2 to 80 L/min


O Max. Peak flow: 120 L/min.
Note:
The SIESTA i TS contains batteries that In VCV and SIMV mode the Tidal volume,
must be exchanged by a technician at Resp. rate, I:E ratio and Insp. pause user settings
certain intervals, as prescribed in the are continuously controlled by the ventilator in
service manual. order to stay within the 2 to 80 L/min continuous
flow limits.

Inspiratory flow = Tidal volume x Resp. rate x


1.3 Performance ((I+E)/I) x (100/(100-Insp. pause))

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:

O 0 to 20 L/min O2 / N2O (O2 0-10 L/min, 60 L/min 30 L/min 5 L/min


N2O 0-10 L/min) Expiratory 4.5 2.0 0.3
or resistance (x100Pa) (x100Pa) (x100Pa)
O 0 to 20 L/min O2 / AIR (O2 0-10 L/min, Inspiratory 4.5 2.0 0.3
AIR 0-10 L/min) resistance (x100Pa) (x100Pa) (x100Pa)

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).

The ventilator of the SIESTA i TS is designed


to give an inspiratory flow of: qusjob8.absorberkurver.tif

Dameca 1-3
User Manual for SIESTA i TS

1.4 User Setup


The SIESTA i TS can be set up to match user If volume monitor is activated, the volume
preferences. measurement can be configured in two ways:

The following features can be installed when Only expired volume


the machine is manufactured: If the volume monitor is configured to »only
exp. volume«, the volume sensor must be placed
O Integrated patient suction at the expiratory port of the patient breathing
O Auxiliary freshgas outlet and integrated system. The volume monitor will then measure
auxiliary O2 flowmeter the expired tidal- and minute-volume only.
O Multigas module
O 3 pcs. integrated power outlets Full spirometry
O Extra O2 , AIR or VAC gas outlet If the volume monitor is configured to »full
O 1 or 2 pcs. pin-index yokes for 4 L. gas cy- spirometry«, the volume sensor must be placed
linders or stand for 2 pcs. 10 L. gas cylinders at the Y-piece of the patient breathing system.
O Power unit for AGSS The volume monitor will then measure expired
O PSV accessible or not tidal- and minute volume, inspired tidal volume
O PRVT accessible or not (during manual ventilation) and a pressure/
volume graph (spirometry loop) can be selected
The following parameters can be changed by the user.
after the machine has been manufactured:
All these settings can be changed in the service-
O N2O supply available or not. menu, by a super-user or a technician.
O Pressure unit.
O SIMV accessible or not.
O Ventilator volume setting based on Tidal 1.5 Responsibility of the
volume or minute volume. Manufacturer
O Acetone check available or not
(see section 5.2.4). Dameca a/s is responsible for the effects on
O Freshgas flow safety activated or de- safety, reliability and performance of the
activated (see section 7.3.1 and 7.3.2). equipment only if:
O Start freshgas flow (see section 4.5.1
and 4.5.2). O Personnel authorized by Dameca a/s
O Mean or plateau pressure shown on the carry out assembly, operations, extensions,
display. re-adjustments, modifications, periodical
O Measured TV insp. shown or not during service or repairs.
VCV and SIMV ventilation.
O If multigas module is not installed, oxygen O The pneumatic installation of the relevant
monitor based on external fuel cell sensor rooms complies with appropriate requirements.
can be activated.
O Volume monitor can be activated or O The equipment is used in accordance with
de-activated. this user manual.

1-4 Dameca
User Manual for SIESTA i TS

1.6 Safety Features of the SIESTA i TS Anasthesia Machine


Gas supply
O2, AIR and N2O supply failure alarm. Built-in minimum of 25% O2 in an O2/N2O mix).
check valves to prevent reverse flow of gases.
An MPL (Maximum Pressure Limiting) valve
The ventilator, patient suction (optional) and opens if the pressure of the freshgas flow to the
AGSS power unit (optional) is powered by the auxiliary freshgas outlet exceeds 90 (x100Pa).
primary driving gas (AIR or O2 , normally AIR).
Vaporizer rail
The optional patient suction can also be Back-bar for one or two vaporizers. The back-
powered by VAC (option). bar for two vaporizers is fitted with interlock
system to assure that only one vaporizer can
If the primary driving gas pressure is lost, a be activated one at a time.
driving gas valve automatically switches to
the secondary driving gas source (AIR or O2 , Ventilator
normally O2) A high-pressure alarm will automatically force
the ventilator into its expiratory state, avoiding
Electronic gas mixer dangerous overpressure situations.
N2O cut-off if O2 supply fails. In addition the ventilator has a built-in pressure
Electronic O2/N2O ratio control (secures a relief valve which opens at 90 (x100Pa).

Dameca 1-5
User Manual for SIESTA i TS

Flow Diagram

qusjob42.Siesta i TS flowdiagram.wmf

1-6 Dameca
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.

2.1 Warnings O Humidifiers used with this machine must


conform to EN ISO 8185 or similar standard.
O Do not open service hatches or covers. No
user-serviceable parts inside the machine. O Suction units used with this machine
A qualified service technician should must conform to EN ISO 10079-1,
perform service. EN ISO 10079-2 and EN ISO 10079-3
or similar standard.
O The machine must be connected to correct
grounded hospital grade electrical outlets O Medical gases and anaesthetic agents used
only. with this machine must conform to the
European pharmacopoeia.
O Always unplug the electric power cord
before cleaning or maintenance of the O Central gas supply used with this machine
machine. Let it dry completely before must comply with EN737-1 or ISO7396 or
reconnecting it to the electrical outlet. similar standard.

O Spillage of liquids may cause electrical


shock. Note:
If the central gas supply fails, the
O Check that all cables are in good working auxiliary gas outlet (optional) of
condition before connecting the machine this machine will also fail.
to mains or patient.

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.

O Use only the anaesthetic agent for which


Patient safety the vaporizer is calibrated. Using the wrong
O Do not use the machine for a clinical agent in the vaporizer can be fatal for patients.
procedure without first ensuring that the
complete system is operating correctly. O If a re-usable CO2 absorber is used, the
following must be taken into account during
O If the multigas module of the Siesta i TS change of soda-lime: Soda-lime dust is
is not installed, the machine should always caustic and can produce burns in the respira-
be used with a separate monitor for O2, tory tract if inhaled. Breathing protection
anaesthetic agent and CO2 concentrations. must be used to ensure that no soda-lime
This monitor must comply with the relevant dust is inhaled by personnel or patient.
standards under the EU Medical Device
Directive. O Do not start any test procedure of the
electronic gas mixer or the ventilator with
O If the volume monitor of the Siesta i TS is a patient connected to the machine.
not installed, the machine should always The test procedures are designed to ensure
be used with a separate monitor for expired correct and safe function of the machine.
volume. This monitor must comply with Do not bypass the test procedures unless
the relevant standards or the EU Medical patient safety requires an immediate starting
Device Directive up procedure.

2-2 Dameca
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.

O When using soda lime in absorbers, follow 2.2 Cautions


the manufacturers instructions.
O Before connecting the power cord to the
O If the machine has been used with different electrical power supply outlet check that the
anaesthetic agents, residues of these agents local voltage and frequency are as stated on
(PPM) may still remain in the machine the TYPE label on the rear of the machine.
(vaporizer rail etc.). By setting a high
freshgas flow during a long period of O Do not attempt to connect other cables or
time these residues can be minimized. connectors to the auxiliary power outlets
(optional), than the ones intended for this
O Means to avoid cross infection between purpose.
patients must be used. See section 8
regarding maintenance and cleaning. O Maximum load on side rails at table is
20 kg. Too much heavy equipment attached
O When connecting more than one external at one side of the machine may cause the
equipment to the auxiliary power outlets machine to tilt.
(optional), a high leakage current from one
equipment (f.ex. in case of a defective earth O Maximum total load on table plate
conductor) will affect the leakage current (including side rails) is 40 kg.
from the other equipment.
O Maximum load on top plate is 40 kg.

Note: O Maximum torque on siderails is 20 Nm.


The auxiliary O2 flowmeter (optional)
is by-passing the MPL valve. The pres- O When closing the drawers of the machine,
sure from the flowmeter may exceed observe that nothing gets squeezed or
the pressure from the freshgas outlet. damaged, with special attention to fingers.

O Vaporizers used for Fluothane, Halothane or


other anaesthetic agents containing Tymol or
Failure of operation other stabilisers must be emptied every other
O If the machine fails to respond as described, week, and the agent that is drained must be
do not use until qualified service personnel destroyed.
have corrected the situation.
O Check calibration of vaporizers regularly
using a proper gas indicator (e.g.refracto-
Occupational hazard meter or similar).
O Do not use this machine in insufficiently
ventilated areas. Use scavenging system to O Authorised service personnel should service
avoid increased concentrations of anaest- this machine at least once a year.

Dameca 2-3
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

Type B (EN60601-1) protection Protective earth.


against electrical shock.

Attention, consult accompanying Equipotentiality.


documents.

Adjusment for auxiliary O2 or ON/OFF


patient suction:
Turn counter-clockwise to increase.
Turn clockwise to decrease. WEEE Symbol, meaning that the
electronics must not be regarded
as normal waste.
ON/OFF switch for lamp.

2-4 Dameca
User Manual for SIESTA i TS

3. Function
14
13
3
15
12
11 16
4 17
10 18
19
9 20
IBS 8
7 21
6
22
5
23
24

1 1

qusjob42.10653 front.png

Fig. 3-1 Anaesthesia machine model SIESTA i TS front view

1. Castors with brake 13. Transfusion stand (optional)


2. Drawers 14. Top shelf
3. AGSS ON/OFF (option) and flow marker 15. Main switch
4. Auxiliary oxygen flowmeter outlet 16. 15’’ TFT colour touch screen
(optional) 17. Control wheel
5. Auxiliary freshgas outlet (optional) 18. ON/OFF switch for light
6. CO2 absorber 19. Emergency flow switch
7. Lock for absorber 20. Back-bar for two interlock vaporizers
8. BAG connection 21. Integrated auxiliary oxygen flowmeter
9. APL valve (for manual ventilation only) (optional)
10. Bellows 22. Table with integrated rails
11. O2 flush 23. Integrated patient suction (optional)
12. Water trap for multigas module (optional) 24. Auxiliary freshgas outlet switch (optional)

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

Fig. 3-2 Anaesthesia machine model SIESTA i TS rear view

1. Castors without brake 10. RS232 port


2. Lower fan 11. Auxiliary power outlets (optional)
3. Yokes for spare cylinders (optional) 12. Upper fan
4. Grounding point 13. Gas inlets
5. Mains power inlet switch 14. Insp./Exp. connections for patient
6. Mains power cord breathing system
7. Connections for patient flow sensor 15. Lock for patient breathing system
(optional) 16. Patient suction connection (optional)
8. Auxiliary gas outlet (optional) 17. Connection for optional O2 fuel cell
9. Auxiliary AGSS connection sensor

3-2 Dameca
User Manual for SIESTA i TS

5 6 7 8 9

Freshgas flow EGM 5.0 Thursday 6. December 11:13 Stop watch


4 (L/min) Normal
3.00 00:00:00 10
screen
O2 set % Gas meas. (%)
3 Exp Insp
33
Rotameter % Setup
4 Exp CO2 O2 32 33 11
menu
1.8 N2O 64 63
2 Insp CO2

0.1 SEV 0.4 0.6 Trend


12
menu
2 0 MAC 0.4
(age: 40)

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

Fig. 3-3 Main display if multigas module is installed

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

Freshgas flow EGM 5.0 Thursday 6. December 11:13 Stop watch


4 (L/min) Normal
3.00 Touch screen controlled Selftest bypassed 00:00:00 10
screen
O2 set % O2 meas. %
3
33 32
Rotameter Adult sensor At Y-piece Setup
hPa

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

Flow (L/min) TV(ml) 480 Cancel 14


O2 N2O
1 0 alarms
1.00 2.00
Compl. 34 ml/hPa
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

24 23 22 21 20 19 17
qusjob42.fig. 3-4 without gasmodule vers 3,2.PDF

Fig. 3-4 Main display if multigas module is not installed

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

3-4 Dameca
User Manual for SIESTA i TS

3.1 Anaesthesia Gas Scavenging System (AGSS)


The Siesta i TS anaesthesia machine has a A built-in reservoir in the scavenging system is
built-in scavenging system. This system open to the ambient air and serves as a relief of
requires evacuation flow of 30-40 L/min., the ejector vacuum.
in order to remove excess gases from the
integrated patient breathing system to the An AGSS connector on the rear of the machine
AGSS outlet on the rear of the machine. is for connection of the machine to the central
scavenging system.
The evacuation flow can be generated by the
permanent gas installation in the operating
room, or it can be generated by an air driven Warning:
ejector in the Siesta i TS machine, activated The gases and agents used under
with an ON/OFF switch located at left side of anaesthesia can pose a danger if
the machine, next to the AGSS flow marker. AGSS is not active, or the operating
room is not ventilated properly.

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 side
of the machine (9 on fig. 3-2).
Remove the plug from the auxiliary AGSS
connection (30 mm female cone) and connect
qusjob33.flowmark.pcx

Fig. 3-5 Flow marker the external breathing system.

The air driven ejector is optional.


Warning:
An AGSS flowmarker at left side of the
machine contains a yellow ball which is The external breathing system must
visible when the flow is 25 L/min or more. have an open reservoir integrated into
the AGSS part of the system.
Otherwise the auxiliary AGSS flow
Note: can create a sub-atmospheric pressure
in the external breathing system,
The AGSS flowmarker is for the IBS which can be dangerous to the patient.
(Integrated Breathing System) only.
If an external breathing system is
used, this system must be equipped
with an indicator for the AGSS flow. 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).

Dameca 3-5
User Manual for SIESTA i TS

Left blank intentionally

3-6 Dameca
User Manual for SIESTA i TS

4. Operation
4.1.1 Integrated breathing system
Note:
Before using the machine the first time
it must be electrical safety tested
according to EN 60601-1, and all
patient related parts must be cleaned.
2

1
5
Note:
3
Before connecting the machine to a
patient, a function test must be carried 6
out as described in section 4.2. 4

Note:
Check voltage rating on the type label
at the rear panel of the machine, qusjob42.10653-00 slange.pdf

before connecting it to the mains.


O Assemble the integrated breathing system
(see section 8), connect it to the base (1)
and lock it by using the handle (2).
4.1 Set Up O Connect i-SORB CO2 absorber (5) to the
integrated breathing system, by placing
O Connect the machine to the mains. it into the bracket underneath the base
O Connect the machine to the pressurised and pulling up, until the lock »clicks«.
gases (400 - 600 kPa), vacuum (optional)
and AGSS.
O Activate AGSS flow and check that the yellow Caution:
ball in the flow marker (3 on fig. 3-1) appears. If a disposable i-SORB CO2 absorber is
The AGSS flow can be generated by the
used with the system, the seal on a new
machine (optional) or by a unit in the AGSS
absorber must be removed, before the
installation of the hospital. If the AGSS flow
absorber is connected to the integrated
must be generated by the machine, it can
breathing system.
be activated by pressing the red/green pin
placed above the flow marker (3 on fig. 3-1).

Dameca 4-1
User Manual for SIESTA i TS

O Connect inspiratory and expiratory hoses


(3) to the connections marked INSP and
EXP on the integrated breathing system,
Note:
including Y-piece (4) and bacteria filter If an i-SORB CO2 absorber is not
(P/N 38477). The bacteria filter can be reinserted within 30 sec., a message
placed at the Y-piece or at the expiratory will be shown on the display:
connection of the IBS system. »Absorber disconnected«.
O Connect manual respiration bag (6) to the
connection marked BAG on the integrated If the ventilator is in automatic
breathing system. A hose can be placed ventilation mode, this message
between BAG connection and respiration will be followed by an alarm.
bag to give better flexibility for the user.

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«.

If the ventilator is in automatic


ventilation mode, this message
will be followed by an alarm.

21-12-2004 09:47

qusjob42.10653ny.pdf

4-2 Dameca
User Manual for SIESTA i TS

4.1.2 Changing the CO2 absorber

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.

4.1.3 External breathing system


Other breathing systems than the integrated
breathing system can be used with the
Siesta i TS anaesthesia machine.

O Assemble the breathing system and connect


it to the auxiliary freshgas outlet (optional)
placed at left side of the writing table
21-12-2004 09:47

(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«.

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.

The machine can be installed with 2 different types of multigas modules, each with different kind of
water trap.

If the water trap is filled with water, it must be replaced.

Water trap part no. Sample flow Capacity Max. lifetime

Gasmodule A 41020-25 (1 pcs.) 200ml/min. 22ml 3 months

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

4-4 Dameca
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.

The machine uses two different flow sensors:


Paediatric flow sensor is used for patients with hPa Adult sensor At Y-piece Peak
tidal volume from 20 to 300 ml (insp./exp. flow 17 30

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

I:E PEEP P Insp


If the flow sensor is placed on the expiratory Ratio (hPa) (hPa)

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.

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.

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

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.

4-6 Dameca
User Manual for SIESTA i TS

4.1.6 O2 fuel cell sensor

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:

O Connect cable between O2 sensor and


:13 Stop watch
Normal
connector (17 on fig. 3-2) on rear panel
sed 00:00:00 of the machine.
screen
O2 meas. %

32
Setup

menu

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

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.

O Push the main switch on front of the machine


(15 on fig. 3-1) to set it to ON position. Warning:
The patient must not be connected to
the machine at power-up or during
Note: the functional test.
If a »mains failure« alarm is given
when the main switch on front of
the machine is set to ON position,
this is most likely caused by the Now the machine will power up and perform an
mains power inlet switch on rear side initial self-test checking the internal system for
of the machine not being set to ON. safe condition and performing test sequence 1.
This takes approx. 1 minute.

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.

4-8 Dameca
User Manual for SIESTA i TS

When the initial self-test has been successfully Test sequences:


completed, the machine is in Stand-by mode
Start-up
and the full selftest can be performed.
Display: »Do you want to perform FULL
TEST: Y/N«
4.2.1 FULL self test »Patient must NOT be connected
During the FULL selftest the machine checks during test«
its functions, measures the compliance of the »Select Y or N and press to continue«
system and checks for leakages. The compliance
and leakage test includes the integrated breathing O Change between Y and N by turning the
system incl. hoses and Y-piece. control wheel, and press enter to select.
O By selecting Y the FULL selftest is started.
When the mains switch (15 on fig. 3-1) is set to O By selecting N the FULL selftest is bypas-
ON by the user, the machine automatically sed. This should only be done in case of an
performs test sequence 1 to ensure the correct emergency.
function of its mandatory components. Then test
sequence 2 is activated. 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:
Note:
If a system related alarm (see section 7) Display: »Do you want to bypass selftest:
is detected after power-up of the Y/N«
machine, the selftest is not started. »Only bypass in case of an
Instead the alarm is shown on the emergency«
display. When the alarm is no longer »Select Y or N and press to continue«
active, press »cancel alarms« and the
selftest will start.
O Change between Y and N by turning the
control wheel, and press enter to select.
O By selecting Y the FULL selftest is bypas-
sed. This should only be done in case of
an emergency.
When »FULL TEST« is selected by the user O By selecting N the FULL selftest is started
(by selecting »FULL TEST« in the selftest again from the beginning.
menu, included in the setup menu, and pressing
the control wheel), start-up sequence is
activated before going to test sequence 1. Warning:
If the FULL selftest is bypassed, some
of the functions of the machine will
Note: not be checked. The user must then
increase observation of the patient
During the full selftest all alarms
during anaesthesia, in order to
are disabled.
maintain a safe function.

Dameca 4-9
User Manual for SIESTA i TS

2. Gasmixer test
Warning: Display: »Occlude Y-piece (use testadapter)«.
If the FULL selftest is bypassed, the »Check gas evacuation (flow marker)«
compliance and leakage of the integra- »Set APL valve to 35 hPa«
ted breathing system are not measured. »Open vaporizer«
The ventilator therefore uses the data »Press to start«
from last selftest, and therefore the »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«

The functionality of the electronic gasmixer


is checked.

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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4. Compliance and leakage, VENT Display: »Leakage in VENT system XXX


ml/min. Accept: Y/N«
Display: »Leakage test of system is running« »Check BiB, connectors and hoses«
»Select N to repeat test. Select Y to
The electronic gas mixer generates a flow of continue«
10 L/min O2 and 9.75 L/min AIR for 10 seconds
to fill the bag in the Bag in Bottle system. O Change between Y and N by turning the
control wheel and press enter to select.
After this the electronic gas mixer generates O By selecting Y the measured leakage is
a flow of 5 L/min O2 and the pressure in the accepted, and the next test sequence will
patient system is checked (should be 1.5 to be performed.
4.5 hPa due to Bag in Bottle). O By selecting N the measured leakage is not
accepted, and the compliance and leakage
Then the compliance of the VENT system is test will be performed again.
measured, based upon the volume required from
the ventilator to reach a 30 hPa pressure If the leakage is more than 1000 ml/min, an
in the patient system. error message will be shown on main display:

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.

When the 30 hPa pressure is reached, the


leakage of the VENT system is measured, based
5. Leakage, BAG
upon the pressure drop during time, taking into The BAG/VENT valve in the integrated
account the compliance of the system. breathing system is set to BAG and the
If the pressure drops too fast for the leakage to pressure in the patient system is measured
be measured, an error message will be shown on to detect possible leakage from the APL valve
main display: or the respiration bag. If the pressure has
dropped to a value below 10 hPa, an error
Display: »Leakage too high« message will be shown on main display:
»Check BiB, connectors and hoses«
»Press to repeat test« Display: »Leakage in BAG system too high
(pressure below 10 hPa)«
When the control wheel is pressed, the compli- »Check APL valve and resp. bag
ance and leakage test will be performed again. (empty ?)«
»Press to repeat test«
If the leakage is more than 100 ml/min but
less than 1000 ml/min, 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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6. Leakage, BAG/VENT, exp. valve


and peep valve

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«

O Change between Y and N by turning the


control wheel, and press enter to select. Warning:
O By selecting Y the LC selftest is started. The patient must not be connected to
O By selecting N the LC selftest is bypassed. the machine during the LC selftest.
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 Test sequence 2 to 7 from the FULL selftest
text will be shown: are carried out.

Display: »Do you want to bypass selftest:


Y/N«
4.2.3 O2 monitor test
»Only bypass in case of an 4.2.3.1 Fuel cell sensor
emergency« If the machine is set up with an O2 monitor
»Select Y or N and press to using an external fuel cell sensor (see section
continue« 4.1.6), the following test must be carried out:

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User Manual for SIESTA i TS

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.

3. Set freshgas flow to 10 L/min O2, and wait


until O2 % reading on main display is stable.
4.2.5 Airway pressure high alarm
Check that the reading is 98-102 % O2. If 1. Attach a test lung to the Y-piece and start the
not, recalibrate the O2-monitor as described ventilator. Read PEAK pressure on main
in section 6.1.6. display and set airway pressure high alarm
limit 5 hPa below PEAK pressure.
4.2.3.2 Multigas module Check that the »airway pressure high« alarm
If the machine is set up with an integrated starts and that the PEAK pressure is now
multigas module, the following test must reduced by the new airway pressure high
be carried out: alarm limit. Set the airway pressure high
alarm limit as before (above PEAK pressure)
1. Set status to MANUAL. Y-piece must be and check that the alarm stops.
open to ambient air.

2. Set freshgas flow to 10 L/min AIR, and wait


4.2.6 Mains failure alarm
until O2 % reading on main display is stable. 1. Attach a test lung to the Y-piece and start the
Check that the reading is 19-23 % O2. ventilator. Disconnect mains cable to the
machine from the mains outlet. Check that
3. Set freshgas flow to 10 L/min O2, and wait the »mains failure« alarm starts, and that the
until O2 % reading on main display is stable. machine continues to function. Re-connect
Check that the reading is 97-103 % O2. mains cable.

4.2.4 Expired minute volume 4.2.7 O2 flush


If the machine is set up with a volume monitor 1. Set status to MANUAL. Occlude the
(see section 4.1.5), the following test must be Y-piece. Press O2 flush and check that
carried out: the respiration bag is quickly filled.

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4.2.8 O2 alarm 4.2.10 Patient suction test

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.

3. Start suction by activating the ON/OFF switch.


4.2.9 Spare cylinder test
If the machine is equipped with spare cylinders 4. Verify that the vacuum gauge indicates a
for O2 or N2O, the following test must be vacuum of at least -0.7 kPa.
performed:
5. Adjust the desired vacuum by means of the
1. Disconnect the central gas supply tubings regulator knob.
for O2 and N2O.
6. Close the ON/OFF switch.
2. Open the valves of the spare O2 and N2O
cylinders. 7. Re-mount the plastic tubing on the suction
container.
3. Set the »Carrier gas« in the setup-menu to N2O.

4. Set »Total freshgas flow« to 0.0 L/min.


4.2.11 Vaporizer test
The user must check the functionality of the
5. Read the pressure on the spare cylinder vaporizer(s) by the following procedure:
pressure regulator gauges on rear side
of the machine. 1. Verify that the required vaporizer(s) is
connected.
6. Check for sufficient cylinder pressure
(the pressure of the cylinders must never 2. Check that the regulator knob on the vapori-
be below 10 bar). zer(s) turns freely in the entire regulation
area and is locked in the »0« position.
7. Close the spare cylinder valves.
3. Verify that the vaporizer is sufficiently filled.
8. Observe the pressure gauges for at least
one minute. The pressure must not
decrease.
Note:
9. Reconnect the central supply tubings to the Consult the vaporizer user manual.
central gas supply.

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4.2.12 Aux. O2 flowmeter test Display: »Emergency O2 flow activated«


»App. 5 L/min. added to the O2
If the machine is equipped with an auxiliary O2 flow setting«
flowmeter unit, the user must check the functio-
nality of this unit by the following procedure: De-activate the switch and check the message
disappears.
1. Open the flow meter regulator (turn it
counter-clockwise). 4. If the machine is equipped with an auxiliary
freshgas outlet, activate the switch and check
2. Check that the flow can reach 10 ltr/min. the following message appears on the display:

3. Close the regulator (turn it clockwise) Display: »External freshgasoutlet activated«


and check there is no flow.
De-activate the switch and check the message
disappears.
4.2.13 Test of internal switches
1. Remove the CO2 absorber and check the
following message appears on the display
4.2.14 Daily check completed
(after app. 30 sec.): 1. Set status to STBY.

Display: »Absorber disconnected« 2. Go to Alarm menu and select »Alarm log«


and then »Reset«.
Re-mount the CO2 absorber and check the
message disappears. 3. Go to Alarm menu and select »Set to
default«.
2. Remove the integrated breathing system
(unlock handle) and check the following 4. Press »Cancel alarms« to remove old
message appears on the display: alarm text from the display.

Display: »Patientsystem disconnected«


Caution:
Re-mount the integrated breathing system and When the function test has been
check the message disappears. completed, check that the alarm settings
are suitable for the patient, before
3. Activate the emergency freshgas switch and connecting the patient to the machine.
check the following message appears on the
display:

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4.3 Operation of Electronic Gas Mixer

When the selftest is completed the electronic


gas mixer (EGM) is ready for use.

Turning the control wheel counter-clockwise


will decrease the flow.
Freshgas flow
4
(L/min)
Turning it clockwise will increase the flow.
3.00 The flow is changed immediately as the user
O2 set % changes the set-flow by turning the control-
3
wheel.
33
Rotameter
2. Setting the O2 percentage (3), or the total
flow (4), by pressing the appropriate field
on the main display.

2 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 changed immediately, when the


Flow (L/min) control wheel is turned.
O2 N2O
1
1.00 2.00 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.
4.3.1 Setting of freshgas flow If the set values and the measured values do
The freshgas flow can be set in two ways: not match over a certain period of time, the
machine will generate an alarm.
1. Setting the flow for each gas, by pressing
the set-flow value (1) on the main display. If an oxygen flow less than 300 ml/min is
Then the value is highlighted (blue) and the set, a message » O2 flow critical low« is
specific gasflow can be changed by turning displayed in the alarm and message field
the control-wheel. (5 on fig. 3-3).

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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
Note:
flow will automatically be set to 0 L/min, The displayed values are based
and the O2 set percentage will be changed on STPD conditions (Standard
accordingly. Temperature Pressure Dry).

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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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/min
Carrier gas AIR AIR, N2O

4.4 Operation of stopwatch

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.

O 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.

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4.5 Operation of Ventilator

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

Flow (L/min) PEEP TV(ml) 480 Cancel


O2 N2O 3
0
OFF
alarms
1.00 2.00 Compl. 34 ml/hPa RR(1/min) 12 4

TV set RR set I:E PEEP P Insp Vent. mode Status


(ml) (1/min) Ratio (hPa) (hPa)
PSV settings
500 12 1:2 OFF (17) VCV VENT

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:

Time, pressure graph in previous mode.

Time, pressure graph in SIMV mode.

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.

Time, pressure graph in SIMV mode.

Triggering is never possible during


insp.time + 200msec.

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.

Note: For the 5. and more inspirations the inspiratory


flow will be adjusted automatically by the
PSV mode is an option which can be ventilator, based upon the measured expired
installed on the machine by Dameca tidal volume.
or an authorized technician.
If the ventilator detects that the inspiratory
pressure required to reach the set tidal volume is
less than 4 hPa, then the inspiratory pressure will
be set to 4 hPa and a REQUIRED INSP.
Note: PRESSURE IS TOO LOW alarm will start
PSV mode is only available if the (see section 7)
volume sensor is placed at the Y-piece.
If the ventilator detects that the inspiratory
pressure required to reach the set tidal volume is
more than 67 hPa, then the inspiratory pressure
In PRVT mode a certain inspiratory pressure is will be set to 67 hPa and a REQUIRED INSP.
applied to the patient during inspiration, by a PRESSURE IS TOO HIGH alarm will start
decelerating inspiratory flow. The adjustment (see section 7)
of the inspiratory flow done by the ventilator is
identical to the PCV mode. The difference is that If the ventilator detects that the inspiratory
in PRVT mode the ventilator changes the pressure required to reach the set tidal volume is

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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.

Press the TV set / MV set field and select the


desired tidal volume / minute volume with the
Note: control wheel (17 on fig. 3-1).
PRVT mode is an option which can be Press the control wheel to confirm the selected
installed on the machine by Dameca or tidal volume/minute volume.
an authorized technician.
The tidal volume/minute volume will not
change until the control wheel is pressed.

In the service menu it is defined whether the set


Note: volume should be tidal volume or minute volume.
PRVT mode is only available if the This definition can be changed by a super-user
volume sensor is placed at the Y-piece or a technician.
or at the EXP cone on the IBS.
(Minute volume = Tidal volume x Resp. rate).

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C. Respiration Rate E. PEEP


The number of controlled respirations pr. minute. The ventilator can generate PEEP (Positive
Press the RR set field and select the desired End Expiratory Pressure).
respiration rate with the control wheel
(17 on fig. 3-1). Press the control wheel to If PEEP is set to OFF, the PEEP in the patient
confirm the selected respiration rate. system will be app. 3 hPa (depending on the
The respiration rate will not change until the freshgas flow) due to the Bag in Bottle system.
control wheel is pressed.
Press the PEEP field and select the desired
D. I:E Ratio PEEP with the control wheel (17 on fig. 3-1).
The timing between the inspiratory and the
expiratory phase. Press the control wheel to confirm the selected
PEEP.
Press the I:E Ratio field and select the desired
I:E ratio with the control wheel (17 on fig. 3-1). The PEEP will not change until the control
Press the control wheel to confirm the selected wheel is pressed.
I:E ratio.

The I:E ratio will not change until the control


wheel is pressed. Note:
PEEP + Inspiratory Pressure can
max. be 70 hPa.
Note:
Some combinations of tidal volume,
respiration rate, I:E ratio and inspiratory
pause cannot be set on the ventilator, Note:
because the continous inspiratory flow
must be between 2 and 80 L/min. PEEP cannot be set above the High
If the 2 L/min. or the 80 L/min. limit alarm setting.
is reached, a message will be shown
on the display.
F. Inspiratory Pressure (active in PCV
mode only)
Inspiratory flow = Tidal volume x respiration The inspiratory pressure above PEEP applied
rate x ((I+E)/I) ) x (100/(100-insp.pause %)). to the patient in PCV mode.

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.

Press the P Supp. field and select the desired


Note: support pressure with the control wheel
PEEP + Inspiratory Pressure can (17 on fig. 3-1).
max. be 70 hPa.
Press the control wheel to confirm the selected
support pressure.

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.

Note: Turn the control wheel (17 on fig. 3-1) until


During an »airway pressure high« Insp. pause is highlighted, and press the control
alarm, the freshgas will automatically wheel in order to activate setting of inspiratory
be set to 0.3 L/min O2, in order to pause.
avoid dangerous over-pressure situa-
tions in case of high freshgas flow. Turn the control wheel in order to change the
When the alarm is no longer active, insp. pause setting, and then press the control
the freshgas flow will automatically wheel to confirm the new setting.
be set to the original values.
The inspiratory pause will not change until the
PS: This functionality can be control wheel is pressed.
disabled in the service-menu,
by a super-user or a technician. SIMV trigger point
If ventilation mode is set to SIMV, the patient
can trigger a VCV inspiration during the expira-
tion phase, by applying a decrease of the airway
pressure in the patient system.
Note:
High alarm is active during automatic The decrease of airway pressure is relative to
ventilation only. the set PEEP.

Turn the control wheel (17 on fig. 3-1) until


SIMV trig is highlighted, and press the control
wheel in order to activate setting of SIMV
Note: trigger point.
High alarm cannot be set below the
PEEP setting. Turn the control wheel in order to change the
SIMV trigger point setting, and then press the
control wheel to confirm the new setting.

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 tidal volume percentage being added and


how often this should occur can be defined in
Note: the setup menu.
In the service menu it can be defined
whether SIMV should be accessible Press enter on the control wheel to activate the
or not. This definition can be changed Sigh sub menu.
by a super-user or a technician.

The sigh sub menu has the following settings:


PSV backup period
If ventilation mode is set to PSV, and the patient O Activate
does not trigger en inspiration before the PSV O Frequency
backup period has ended, the ventilation mode O Added TV %
will automatically change from PSV to PCV.
Actual selection is highlighted.
Turn the control wheel (17 on fig. 3-1) until Activate the setting by pressing the control
PSV backup is highlighted, and press the con- wheel (17 on fig. 3-1).
trol wheel in order to activate setting of PSV
backup period. Change the setting by turning the control
wheel, and press enter to confirm.
Turn the control wheel in order to change the
PSV backup period setting, and then press the The setting will not change, before enter is
control wheel to confirm the new setting. pressed on the control-wheel

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.

On the display is shown whether sigh is


Note: activated or not.
In the service menu it can be defined Leave the menu by pressing the normal
whether PSV should be accessible or screen field.
not. This definition can only be
changed by a technician. 4.5.1 Start Automatic Ventilation
Press the Status field, and select VENT with
the control wheel (17 on fig. 3-1),
Sigh
The ventilator can generate a sigh in VCV or Press the control wheel in order for the ventila-
SIMV mode. tor to start ventilating the patient with the set
parameters.
A sigh is a certain percentage tidal volume
being added during inspiration. All parameters can be changed in VENT mode.

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User Manual for SIESTA i TS

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.

PS: In the service menu this default


freshgas flow can be changed, by a 4.5.3 Set Machine to Stand-by
super-user or a technician. If a patient is not connected to the anaesthesia
machine, it can be set to stand-by in order to
stop ventilation and freshgas flow and disable
all alarms related to the patient.
4.5.2 Stop Automatic Ventilation
Press the Status field and select MANUAL Press the Status field, and select STBY with
with the control wheel (17 on fig. 3-1). the control wheel (17 on fig. 3-1),
Press the control wheel in order for the ventila-
tor to stop automatic ventilation of the patient. All parameters except freshgas flow settings
can be changed in STBY mode.
When the status is set to MANUAL, the
patient can be ventilated manually with
the respiration bag. Note:
If the status is changed directly from
Adjust the APL valve (9 on fig. 3-1) in order to VENT to STBY, an alarm will start and
limit the airway pressure during manual ventilation. the text »Do you want to set machine
status to STBY ? Y/N« will be shown
All parameters can be changed in MANUAL mode. on the display. The status will not
change until Y or N has been selected.

Note: If the user selects Y, the status will be


If the freshgas flow is set to 0.0 L/min changed to STBY.
when the manual ventilation is started,
the electronic gas mixer will automati- If the user selects N, the status will still
cally start an O2-flow of 300 ml/min. be VENT.

PS: In the service menu this default


freshgas flow can be changed, by a
super-user or a technician.

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4.5.4 Ventilator default settings

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:

Parameter Factory set value Limits


Ventilation mode VCV VCV, SIMV, PCV, PSV, PRVT
Tidal Volume/Minute Volume 500 ml / 6.0 L 20-1500 ml / 0.2-60.0 L
Respiration rate 12 bpm 4-80 bpm
I:E ratio 1:2 3:1 - 1:9.9
PEEP OFF OFF, 4-20 (x100Pa)
Inspiratory pressure 17 (x100Pa) 4-67 (x100Pa)
PSV insp. trigger flow 3 L/min. 1-10 L/min
PSV exp. trigger flow 40% 10-80%
PSV support pressure 7 (x100Pa) 4-50 (x100Pa)
High pressure alarm 30 (x100Pa) 10-80 (x100Pa)
Inspiratory pause 0% 0-70%
SIMV trigger point -3.0 (x100Pa) -0.5 to -10.0 (x100Pa)
PSV backup period 30 sec. 10-40 sec.
Sigh Activate: N Activate: Y-N
Frequency: 100 bpm Frequency: 50-150 bpm
Added TV: 50% Added TV: 30-80%

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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.

5.1 Respiration Measurements The measured expired minute volume is shown


as »MV exp« in litres, based on the expired
5.1.1 Volume measurements tidal volumes during the last 60 sec. Beside the
Measurement of expired minute volume and actual value for the expired minute volume are
inspired/expired tidal volume can be shown the high and low alarm limits for the expired
on the display, if the Siesta i TS is set up with minute volume.
a patient flow sensor (see section 4.1.5).
The measured inspired and expired tidal volume
for each breath is shown as »TV insp/exp« in
(alder: 40) ml. When the ventilator is set to automatic
Resp. måling ventilation and the ventilation mode is VCV or
Peak
SIMV, the inspired tidal volume is not shown,
17 30
8.0 as the tidal volume is controlled by the machine,
MVexp(l) 5.8 4.0
based on the ventilator settings.
Plateau
17 Exp
TV(ml) 480
PEEP Note:
3 In the service menu it can be defined
OFF
Compl. 34 ml/hPa RR(1/min) 12 4 whether TV insp. should be shown du-
ring VCV or SIMV ventilation. This
Vent. mode S definition can be changed by a super-
user or a technician.
If the flow sensor is placed on the expiratory
side, the expired tidal volume and minute
volume are measured.
Accuracy of volume measurements
If the flow sensor is placed at the Y-piece, the The patient flow sensor used for measuring
inspired tidal volume is also measured, and a expired minute volume and inspired/expired
spirometry-graph (pressure, volume) can be tidal volume measures the actual inspiration/
shown on the main display. expiration flow in real-time.

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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User Manual for SIESTA i TS

This inspired/expired flow measured by the 5.1.3 Respiration graph


patient flow sensor is dependent upon the actual
gas concentrations of the flow being measured, On the display a time-pressure or a pressure-
due to the different densities for the gases volume graph is shown, depending on the user
setting in the setup menu (see section 6.1)
If the Siesta i TS is set up with an integrated
multigas module, the measured minute volume
and tidal volume will be calculated based upon the
5.1.4 Pressure measurements
actual gas concentrations at the patient flow sensor. Beside the graph, some measured pressures are
shown.
If an integrated multigas module is not installed,
the measured minute volume and tidal volume The maximum pressure detected during last
will be calculated based upon the set gas inspiration is shown as PEAK pressure.
concentrations of the freshgasflow.
The pressure detected at the end of last inspira-
Therefore, if the gas concentration at the tion period is shown as Plateau pressure. Instead
patient flow sensor is different from the gas of Plateau pressure, the Mean pressure detected
concentration of the freshgasflow, this will during last respiration (insp. and exp.) period
affect the accuracy of the volume measurement. can be shown.

The pressure detected at the end of last expira-


5.1.2 Respiration rate measurement tion period is shown as PEEP.
The measured respiration rate for the patient is
shown in breaths per minute as »RR«.
Note:
Beside the actual value for the respiration In the service menu it can be defined
rate are the high and low alarm limits for the whether Plateau pressure or Mean
respiration rate. pressure should be shown.
This definition can be changed by
a super-user or a technician.
Note:
The measurement of the respiration rate
is based on the measured CO2 concen-
trations from the patient. Therefore the 5.1.5 Compliance
measurement of respiration rate is only
Beside the graph, the calculated compliance is
present if the machine is set up with an
shown as ml/hPa.
integrated multigas module.
Compliance = expired tidal volume /
(meas. Plateau - meas. PEEP).

Compliance tells which pressure increase is


needed in order to deliver a certain tidal
volume to the patient.

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5.2 Gas Measurements


Measurement of expired and inspired gas concentrations in the patient breathing system can be
shown on the display, if the machine is set up with an integrated multigas module (optional).

EGM 5.0 Thursday 6. December 11:13 Stop watch

Touch screen controlled Selftest bypassed 00:00:00


Gas meas. (%)

Exp Insp

4 Exp CO2 O2 32 33
1.8 N2O 64 63
2 Insp CO2

0.1 SEV 0.4 0.6


0 MAC 0.4
(age: 40)

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.

Thereby no gases are lost due to the integrated multigas module.

Two types of multigas modules can be installed in the machine:


Module A with one water trap with sampleflow 200 ml/min.

Module B with two types of water trap; Adult (sampleflow 200 ml/min.) and
Neonate (sampleflow 70 ml/min.).

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User Manual for SIESTA i TS

Parameter Data range Resolution For example:


Insp O2 % 0-100 % 1% Exp AA = 2 % SEV and Exp N2O = 30 %,
gives the following MAC value:
Exp O2 % 0-100 % 1%
Insp N2O % 0-100 % 1%
MAC = (2/2,05) + (30/100) = 1,28.
Exp N2O % 0-100 % 1%
Insp CO2 % 0-10 % 0.1 % If the patient age has been defined in the setup
Exp CO2 % 0-10 % 0.1 % menu (see section 6.1.1), the MAC value will
Insp AA % HAL, ENF, 0.1 % be corrected accordingly:
ISO: 0-7,5 %
SEV: 0-9 % MAC corrected = MAC x 10 (-0,00269 x (40-age))
DES: 0-20 %
Exp AA % HAL, ENF, 0.1 % according to W.W. Mapleson in British Journal
ISO: 0-7,5 % of Anaesthesia 1996; 76: 179-185
SEV: 0-9 %
DES: 0-20 %
Note:
If the patient age has not been defined
in the Patient data menu (see section
Note: 6.1.1) the MAC value will be based
During use, the multigas module will on a patient age of 40 years.
automatically initiate zero calibration
at certain intervals. During a zero cali-
bration, the message »Gasmodule cali-
brating« will be shown on the display. 5.2.2 Anaesthetic agent
During this, the gas measurement
values will not be present on the display. The multigas module automatically identifies
the anaesthetic agent, which is then shown on
the display.

The primary anaesthetic agent is shown in the


5.2.1 MAC value »Gas measurement« field.
The MAC (Minimum Alveolar Concentration)
value is shown on the display, as a calculated If a secondary anaesthetic agent is present
value based upon the following: (for example due to a change in the anaesthetic
agent being used), a message will be initiated,
MAC = (Exp AA % / X) + (Exp N2O % / 100) and the secondary agent will be shown on the
display, in the message-field (5 on fig. 3-3) as:
where X depends upon the actual anaesthetic agent.;
X(HAL) = 0,75 % »Secondary agent HAL/ENF/ISO/SEV/DES
X(ENF) = 1,7 % identified at insp/exp x.x/y.y %«.
X(ISO) = 1,15 %
X(SEV) = 2,05 %
X(DES) = 6,0 %

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User Manual for SIESTA i TS

5.2.3 Detection of ethanol (module A only)

The multigas module checks the expired gases


Note:
from the patient for concentrations of ethanol In the service menu it can be defined
(alcohol) at all time. whether »Acetone check« should be
available or not. This definition can
If ethanol is detected, a message will be be changed by a super-user or a
initiated, and the ethanol concentration will technician.
be shown on the display, in the message-field
(5 on fig. 3-3) as: »Ethanol identified at
insp/exp x.x/y.y %«.
5.2.5 CO2 graph
5.2.4 Detection of acetone (module A only) On the display a CO2 graph is shown.
During start up and before an anaesthetic agent Beside the graph, the inspired and expired
is identified, the multigas module can check for CO2 concentrations are shown digitally.
concentrations of acetone in the expired gases
from the patient. The measurement-unit for the CO2
concentrations can be changed in
Press the »Acetone check« field in the CO2- the setup menu (see section 6.1.7).
curve field (7 on fig. 3-3), and the gas module
will check for concentrations of acetone.

When the check has been performed, a message Note:


will be shown on the screen, indicating whether If the freshgas flow is 0.0 L/min., the
acetone has been detected or not. machine status is »MANUAL« or
»STBY« and there is no detected
respiration rate for more than 10 min.,
Note: the multigas module goes to standby
During a check for acetone, the gas mode.
measurement values will not be »Gasmodule is in standby mode«,
present on the display. »Open freshgas flow or start ventilator
to activate« is shown on the display.
When freshgas flow or ventilator is
activated the multigas module will
Note: start again, and measurements will
be shown after app. 20 sec.
When an anaesthetic agent has been
detected by the multigas module, the
»Acetone check« field will no longer
appear on the display, as the detection
of acetone is not accurate, when an
anaesthetic agent is present.

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Left blank intentionally

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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:

O Setup menu O Carrier gas (only if both AIR and N2O


O Trend menu are activated in the service menu).
O Alarm menu O Patient data (sub-menu).
O Spirometry (sub-menu, only if volume
sensor is activated).
O Graph (sub-menu).
Normal O Vent. settings (sub-menu).
O Selftest (sub-menu).
screen O O2 % calibration (only if multigas module
is not installed, and O2 monitor with
external fuel cell sensor is activated
in the service menu).
Setup O Gas meas. setup (sub-menu).
O Clock (sub-menu).
menu
O Reset settings & data.
O Print report (only if print option is installed).
O Service (sub-menu).
Trend
Actual selection is highlighted.
menu
Activate the setting by pressing the control
wheel (17 on fig. 3-1).
Alarm
For Carrier gas, change the setting by turning
menu the control wheel, and press enter to confirm.

The setting will not change, before enter is


pressed on the control-wheel.

6.1 Setup Menu


Note:
When pressing the setup menu field, the setup Service menu requires a password
menu appears on the right side of the display. for access.
Select a setting by turning and pressing the
control wheel (17 on fig. 3-1).

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6.1.1 Patient data

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

In this menu, the patient age and ideal weight Note:


can be defined. If the patient age has not been defined
by the user, the MAC value will be
Actual selection is highlighted. based on a patient age of 40 years.
Activate the setting by pressing the control
wheel (17 on fig. 3-1).
Change the setting by turning the control
wheel, and press enter to confirm. When the patient age and the ideal weight have
The setting will not change, before enter been defined, the ventilator settings of tidal/
is pressed on the control-wheel minute volume and respiration rate will change,
in accordance with the patient data.
These new suggested ventilator settings are
based on »Radfords Nomogram«.
Note:
The patient age and ideal weight
cannot be changed when the ventilator Note:
is in automatic ventilation mode. If the patient age and ideal weight
have not been defined by the user, the
ventilator settings will be based on a
patient age of 40 years, and an ideal
When the patient age has been defined, the weight of 70 kg. This gives a set tidal
MAC value on the display (present only if volume of 500 ml and a set respiration
multigas module is installed) will be corrected rate of 12 bpm.
for the patient age, according to the following
equation:

Parameter Factory set value Limits


Patient age 40 years 2-150 years
Patient ideal weight 70 kg 5-100 kg

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6.1.2 Spirometry If the pressure-volume graph is shown on the


display, a spirometry reference loop can be
When spirometry is selected, a sub menu will saved by the user. By doing so, the latest
appear on the display, with the following settings: pressure-volume loop will be saved in the
memory and shown constantly on the
O Sensor. pressure-volume graph as a yellow line.
O Placing. The user can remove this loop or save a new
O Save loop as ref (only if pressure-volume reference loop, which will then overwrite the
graph is shown on the display). old reference loop.
O Remove ref loop (only if a spirometry loop
has previously been saved by the user).
Note:
In this menu the settings for the volume The save loop as ref setting is present,
monitor can be defined. only if the user has decided that the
pressure-volume graph should be shown
Actual selection is highlighted. on the display (see section 6.1.3).
Activate the setting by pressing the control
wheel (17 on fig. 3-1).
Change the setting by turning the control
wheel, and press enter to confirm.
The setting will not change, before enter is Parameter Factory set value Limits
pressed on the control-wheel Patient Adult Adult,
flow sensor Paediatic

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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User Manual for SIESTA i TS

Actual selection is highlighted.


Activate the setting by pressing the control
Note: wheel (17 on fig. 3-1).
The type setting is present, only if it has
been defined in the service menu that Change the setting by turning the control wheel,
volume sensor is placed at the Y-piece. and press enter to confirm.

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.

O Insp. pause If the machine is in PSV mode and the patient


O SIMV trig point (only if SIMV is installed) has not made a supported breath before the
O PSV backup (only if PSV is installed) PSV backup time has ended, the machine will
O Sigh automatically change to PCV mode, and an
O Hide PSV settings (only if PSV is installed) alarm will be given.

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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The machine can generate a sigh during VCV 6.1.6 O2 % calibration


or SIMV ventilation.
When O2 % calibration is selected, the exter-
By selecting Sigh the user can activate or nal O2 fuel cell sensor can be calibrated.
deactivate the sigh function, and adjust the
settings for the sigh function.
See section 4.5 chapter I for further explanation.
Caution:
If the three primary parameters for PSV is If the O2 % calibration is activated,
shown on the display, and the selected
the machine will go to STBY mode.
ventilation mode is not PSV, the user can
select Hide PSV settings in order to hide
these three PSV parameters on the display.

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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If O2 % calibration is activated, the sensor will 6.1.7 Gas measurement setup


be calibrated, by following these sequences:
When gas meas. setup is selected, a sub menu will
A. Place O2 sensor on the inspiratory port of appear on the display, with the following settings:
the patient circuit, including hoses.
Y-piece must be open to ambient air. O Exp. O2 %
Press enter on the control wheel O Insp. N2O %
(17 on fig. 3-1) to confirm. O Exp. N2O %
O Resp. rate
B. The electronic gas mixer automatically O MAC
sets a freshgas flow of 10 L/min AIR. O CO2 unit
Now waiting for stable O2 percentage
is shown on the display. In this menu it can be defined which measure-
ments performed by the multigas module should
When the O2 percentage has stabilised, the be shown on the display.
next step of the calibration procedure will
be started. Actual selection is highlighted.
Activate the setting by pressing the control
C. The electronic gas mixer automatically wheel (17 on fig. 3-1).
closes the AIR freshgas flow, and sets Change the setting by turning the control wheel,
a freshgas flow of 10 L/min. O2. and press enter to confirm.
The setting will not change, before enter is
Now waiting for stable O2 percentage is pressed on the control-wheel.
shown on the display.
When the O2 percentage has stabilised, the
next step of the calibration procedure will Note:
be started. The gas measurement menu is present,
only if the multigas module is installed
D. Press enter on the control wheel (17 on
fig. 3-1) to save the calibration.
Press the normal screen field in order
not to save the calibration. By selecting a parameter, the user can decide
whether the parameter should be shown on the
O2 calibration should be done if the test display or not.
described in section 4.2.3.1 cannot be
succesfully completed.
Note:
If calibration cannot be carried out, the O2 Due to safety not all gas measurement
sensor could be defective. parameters can be removed from the
display.
New O2 sensor has P/N 42035-46.

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User Manual 10970

Parameter Factory set value Limits


Exp. O2 % ON ON - OFF
Insp. N2O % ON ON - OFF
Exp. N2O % ON ON - OFF
Resp. rate ON ON - OFF
MAC ON ON - OFF
CO2 unit % %, kPa, mmHg

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

In this menu the setting of the clock can be


changed for the machine.
Actual selection is highlighted. Note:
Activate the setting by pressing the control If Reset settings & data has been
wheel (17 on fig. 3-1). selected, the trend data and the alarm
Change the setting by turning the control log cannot be restored.
wheel, and press enter to confirm.
The setting will not change, before enter
is pressed on the control-wheel
6.1.10 Print report
Note: If the machine is installed with printer option,
The clock settings cannot be changed the user can get a print out of the trend data, the
unless a password has been given in alarm log and the selftest data.
the service menu.
By selecting Print report the print job is sent to
the external printer, via the external adapter box.
6.1.9 Reset settings & data
When Reset settings & data is selected by the Note:
user, the alarm log and all the trend data will be The external adapter box and printer
reset and all the settings made by the user will must be supplied by Dameca A/S as
go back to default values. a kit.
Reset settings & data can be used before a new
case is started.

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6.1.11 Service 6.2 Trend Menu


When service is selected, a sub menu will appear When pressing the trend menu field, the trend
on the display, with the following settings: menu appears in right side of the display.

O 1. password The actual trend data are shown in the center


O 2. password of the display.
O 3. password
O Versions Select a setting by turning and pressing the
O Calibration control wheel (17 on fig. 3-1).
O Installation
O Miscellaneous The following settings can be accessed in the
setup menu:
By selecting versions, the user activates a
sub menu with information about the software O Page
versions for the different components inside O Table
the Siesta i TS. O 1. Column
O 2. Column
The calibration, installation and O 3. Column
miscellaneous sub menu are only accessible O 4. Column
when the correct password has been given. O 5. Column
However, the super-user password can be given, O Rate
in order for the user to be able to change the O Print (only if print option is installed)
default settings of the Siesta i TS. O Reset
O Selftest data
O Gas usage
Caution:
If the super-user password has been When the trend menu is activated, the latest
given in the service menu, all changes data are shown.
made in the setup menu, trend menu and
alarm menu (except expired minute By selecting page, the user can view the trend
volume alarm limits and high pressure data for other times.
alarm limit) will be stored as new default
settings when the machine is turned off. Each page contains 17 set of parameters.
When a page is filled with data, a new page
is created.
999 pages of trend data can be stored in the
memory of the electronic gas mixer.
Note:
The factory default settings can be By selecting table, the user can decide whether
installed again, in the service menu, table A, B, C, D or E should be shown.
by a technician.
On each table 5 columns with set or measured
parameters are displayed.

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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

The factory setup for the trend tables is the following:

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.

In this sub menu the accumulated use of the


Note: anaesthetic agents (HAL, ENF, ISO, SEV, DES)
Reset trend data before a new case and of the gases used in the freshgas flow
is started. (O2, AIR, N2O) are shown.

It is the intension to show the gas usage for each


patient, and therefore the accumulated usage of
gases will be reset by the following user actions:
Note:
If full selftest or LC test has been
O Performing full selftest or LC test
carried out, or the machine has been
O Selecting »Reset settings & data« in the
powered OFF, the trend data are setup menu
automatically reset.
O Selecting »Reset« in the trend menu
O Powering OFF the machine

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6.3 Alarm Menu


When pressing the alarm menu field, the alarm O High resp. rate (only if multigas module
menu appears in right side of the display. is installed).
O Low resp. rate (only if multigas module
Select a setting by turning and pressing the is installed).
control wheel (17 on fig. 3-1). O Set to default.
The following alarm settings can be accessed O Alarm log (sub-menu).
in the alarm menu:
Actual selection is highlighted. Activate the set-
O CO2 alarms (only if multigas module ting by pressing the control wheel (17 on fig. 3-1).
is installed). A number of the alarm settings can be changed
O High pressure. immediately, by turning the control wheel, and
O Gas meas. alarms (sub-menu, only if press enter to confirm.
multigas module is installed).
O High O2 % (only if multigas module is not The setting will not change, before enter is
installed, and O2 monitor with external fuel pressed on the control-wheel.
cell sensor is activated in the service menu).
O Low O2 % (only if multigas module is not
installed, and O2 monitor with external fuel Warning:
cell sensor is activated in the service menu). The alarms should be adjusted
O High MV exp (only if volume sensor is according to the patient and should
activated in the service menu). not be adjusted to extreme settings.
O Low MV exp (only if volume sensor is
activated in the service menu).

Alarm limit Factory set value Resolution Limits


High pressure 30 (x100 Pa) 1 (x100 Pa) 10-80 (x100 Pa)
High O2 % OFF 1% 19-100 % and OFF
Low O2 % 18 % 1% 18-100 %
High MV exp 133 % of set MV * 0.1 L 0.1-80.0 L and OFF
Low MV exp 66 % of set MV * 0.1 L 0.0-79.9 L and OFF
High resp. rate OFF 1 per min. 4-80 and OFF
Low resp rate 4 1 per min. 4-80 and OFF
* »OFF« when the anaesthesia machine status is set to »STBY« or MANUAL«

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6.3.1 CO2 alarms 6.3.2 Gas measurement alarms

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.

Warning: Actual selection is highlighted. Activate the set-


If the alarms for Exp/Insp CO2 and ting by pressing the control wheel (17 on fig. 3-1).
Respiration rate are disabled, special
Change the setting by turning the control
attention must be given to the patient,
wheel, and press enter to confirm.
since no alarm will be given in case
of an apnea.
The setting will not change, before enter is
pressed on the control-wheel

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Alarm limit Factory set value Resolution Limits


Insp O2 High OFF 1% 18-100 % and OFF
Insp O2 Low 18 % 1% 18-100%
Exp O2 High OFF 1% 10-100 % and OFF
Exp O2 Low 10 % 1% 10-100 %
Insp N2O High Fixed 82 %
Insp CO2 High * 3% 0.1 % 0.1-3 % and OFF
Insp CO2 Low * OFF 0.1 % 0.1-3 % and OFF
Exp CO2 High * 8% 0.1 % 0-15 % and OFF
Exp CO2 Low * OFF 0.1 % 0-15 % and OFF
Insp AA High HAL: 2.2 % 0.1 % HAL, ENF, ISO, SEV:
ENF: 5.1 % 0-15 %
ISO: 3.4 %
SEV: 5.1 %
DES: 18 % DES: 0-30 %
Insp AA Low OFF 0.1 % 0-15 % and OFF
DES: 0-30 %
Exp AA High HAL: 1.5 % 0.1 % HAL, ENF, ISO, SEV:
ENF: 3.4 % 0-15 %
ISO: 2.3 %
SEV: 3.4 %
DES: 12% DES: 0-30 %
Exp AA Low OFF 0.1 % 0-15 % and OFF
DES: 0-30 %

* 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.

6.3.3 Expired minute volume alarm limits


When status is »VENT«, the machine automatically sets the High MV exp and Low MV exp
alarm limits +/- 33 % around the set minute volume for the ventilator.

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:

High MV exp: 8.0 L


Low MV exp: 4.0 L

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User Manual for SIESTA i TS

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

By selecting page, the user can view the alarm


data for other times.
6.3.4 Set alarms to default Each page contains 17 sets of parameters.
When set alarms to default is selected, the When a page is filled with data, a new page is
user will be prompted to answer Y or N. created. 100 alarms can be stored in the alarm-
If Y is selected, all the alarm limits will be log. If the alarm log is full »Alarm log full« will
set to default values. be shown at the end of the log.

The layout of the alarm log table is as follows:

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.

6.4 Menu Structure


The menu structure is organised in order to make settings as user friendly as possible.

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6.4 Menu Structure (continued)

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6.4 Menu Structure (continued)

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6.4 Menu Structure (continued)

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6.4 Menu Structure (continued)

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Left blank intentionally

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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.

All alarms are audible and visible. Most of the


7.1.1 Patientsystem disconnected
audible alarms can be disabled for 120 sec. by The »patientsystem disconnected« alarm is acti-
means of the cancel alarms key (14 on fig. 3-3). vated, if the IBS patientsystem is disconnected
from the IBS-base on the side of the machine.
If an audible alarm is disabled, the alarm will
be shown in yellow letters in the message field Connect the IBS to the IBS-base and lock by
(5 on fig. 3-3), and a timer at the end of the using the handle on back of the IBS-base.
alarm text will count down from 2 minutes.
During the alarm the ventilator cannot be
When an alarm is active, the cancel alarms field started.
on the display flashes in a red colour.
If the ventilator is running when the alarm is
When an alarm is no longer active, the cancel activated, a »ventilator stopped due to patient-
alarms field no longer flashes, and the alarm system disconnected« alarm is activated, the
text is still shown the display, in the message ventilator is stopped and status changed to
field (5 on fig. 3-3), until the user confirms MANUAL.
having observed the alarm, by pressing the
cancel alarms field.
7.1.2 Absorber disconnected
The »absorber disconnected« alarm is activated
Note: if the CO2 absorber has not been connected to
If the anaesthesia machine status is set the IBS system for more than 30 sec. Connect
to STBY, all alarms relating to the pati- the CO2 absorber to the IBS, and lift the handle
ent are disabled. System alarms (such until the lock gives a »click«.
as mains failure alarm) are still enabled.
7.2 Electronic Gas Mixer Alarms
An overview of all the alarms is shown in The following alarms are in relation to the
section 7.6 electronic gas mixer:
O O flow is critical low
2
O O /AIR/N O pressure is low
2 2
7.1 Integrated Breathing System O Electronic gas mixer fan stopped
Alarms O O /AIR/N O freshgas flow is out of control
2 2
O Electronic gas mixer battery low
The following alarms are in relation to the O External freshgas outlet activated
integrated breathing system: O Emergency O2 flow activated

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User Manual for SIESTA i TS

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.

Note: 7.2.5 Electronic gas mixer battery low


If the pressure of the primary drivegas The »electronic gas mixer battery low« alarm is
(normally AIR) is less than 2.5 (x100kPa), activated, if the capacity of the internal battery
then the machine will automatically for the electronic gas mixer and the optional
switch to the secondary drivegas multigas module is too low to secure proper
(normally O2), for use in ventilator function of the electronic gas mixer and the
and suction units. multigas module during a mains power failure.

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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.

During the alarm, the ventilator cannot be started.


7.3.1 Airway pressure high
If the ventilator is running when the alarm is The »airway pressure high« alarm is activated
activated, a »ventilator stopped due to external if the measured pressure in the patient breathing
freshgasoutlet activated« alarm is activated, system is higher than the high alarm limit.
the ventilator is stopped and status changed When the airway pressure reaches the high
to MANUAL. pressure alarm limit, the ventilator goes to
expiration phase to avoid dangerous over-
pressure situations.
7.2.7 Emergency O2 flow activated
The »emergency O2 flow activated« alarm is The high alarm condition will end when one
activated if the emergency O2 flow on the respiration without reaching the alarm limit
machine is activated. This should only be done has passed.
if the electronic gas mixer is not functioning.
»App. 5 L/min added to the O2 flow« is shown
as additional information. Note:
If the electronic gas mixer is functioning, stop Airway pressure high alarm is active
the emergency O2 flow by changing the position during automatic ventilation only.
of the switch

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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.

When the battery capacity is so low that the


7.3.3 Disconnection ventilator cannot be powered by the battery,
The »disconnection« alarm is activated if the »closing down« is also shown on the display,
pressure in the patient breathing system does and the ventilator automatically switches to
not cross a PEEP +2 hPa limit in 15 sec. stand-by mode.

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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.

7.3.7 System pressure 7.3.11 Expired minute volume high/low


The »system pressure« alarm is activated if the (only if volume sensor is installed)
difference between the ventilator pressure to The »expired minute volume high« alarm is
Bag in Bottle and the airway pressure in the pa- activated, if the expired minute volume
tient breathing system is more than 15 (x100Pa). measured using the external flow sensor,
is higher than the alarm limit.
This could be due to the bellows in the Bag in The »expired minute volume low« alarm is
Bottle system being empty. activated, if the expired minute volume,
measured using the external flow sensor,
If the Bag in Bottle is filled, and the alarm does is lower than the alarm limit.
not disappear after approx. 10 seconds, the bag
in bottle system must be checked.
7.3.12 Ventilator mains power failure
The »ventilator mains power failure« alarm is
7.3.8 Pressure limit activated if the mains power to the ventilator is
The »pressure limit« alarm is activated if the lost during use.
max. airway pressure during PCV ventilation
is lower than the set inspiratory pressure.
Note:
7.3.9 Freshgas high The internal batteries are primarily
intended for alarm back-up.
The »freshgas high« alarm is activated if the The machine will work normally
freshgas flow is too high for the ventilator during this period. A »closing down«
settings in VCV or SIMV mode. alarm will appear before the ventilator
Ventilator inspiratory flow - freshgas flow closes down in order not to completely
< 2 L/min. discharge the batteries.

Dameca 7-5
User Manual for SIESTA i TS

7.3.13 Measured TV too high O Insp/exp O2 high/low


O Insp N2O high
The »measured TV too high« alarm is given if O Insp/exp CO2 high/low
the tidal volume measured by the external flow O Insp/exp AA high/low
sensor is higher than 2000 ml (Adult sensor) or O Resp rate high/low
500 ml (Paed. sensor). O Secondary agent identified
O Ethanol detected
O Gas measurement is in standby mode
7.3.14 PSV backup mode activated O Occlusion
The »PSV backup mode activated« alarm is O Sample flow rate error
given if the machine is in PSV mode and the O Invalid O2 sensor offset
patient has not made a supported breath before O Ambient CO2 too high
the PSV backup time has ended. O Sample cell pressure
If this alarm happens, the ventilator will
automatically change to PCV mode.

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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User Manual for SIESTA i TS

7.4.1 Inspired/expired O2 % high/low

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.

The »inspired O2 % low« alarm is activated


if the O2 % measured by the multigas module
7.4.5 Resp. rate high/low
is lower than the alarm limit. The »resp. rate high« alarm is activated if the
respiration rate measured by the multigas
module is higher than the alarm limit.
Note:
If the inspired O2 % is less than 18, The »resp. rate low« alarm is activated if the
respiration rate measured by the multigas
the audible alarm cannot be disabled.
module is lower than the alarm limit.

7.4.2 Inspired N2O % high 7.4.6 Apnea


The »inspired N2O % high« alarm is activated The »Apnea« alarm is activated if the multigas
if the N2O % measured by the multigas module module has not detected any breath for a certain
is higher than 82 %. amount of time. If the status is VENT the alarm
will start 20 sec. after last detected breath. If the
status is MANUAL the alarm will start 60 sec.
Note: after last detected breath.
The audible alarm cannot be disabled.
7.4.7 Secondary agent identified
The »secondary agent identified« alarm is acti-
vated if the multigas module detects a secondary
7.4.3 Inspired/expired CO2 % high/low anesthetic agent in the sample gas flow.
The »inspired CO2 % high« alarm is activated The agent type (HAL, ENF, ISO, SEV or DES)
if the CO2 % measured by the multigas module is shown, and the actual inspired/expired con-
is higher than the alarm limit. centration is also shown, in the CO2 graph field.
When a secondary agent is not identified any
The »inspired CO2 % low« alarm is activated longer, the alarm is cancelled.
if the CO2 % measured by the multigas module
is lower than the alarm limit.
7.4.8 Ethanol detected (multigas
module A only, see section 5.2)
7.4.4 Inspired/expired AA % high/low
The »inspired AA % high« alarm is activated The »ethanol detected« alarm is activated if
if the AA % measured by the multigas module the multigas module detects ethanol in the
is higher than the alarm limit. sample gas flow.

Dameca 7-7
User Manual for SIESTA i TS

The actual inspired/expired concentration is


shown in the CO2 graph field.
Note:
When ethanol is not identified any longer, the If the »occlusion« alarm has been
alarm is cancelled. active for more than one minute, the
sample flow will stop, in order to
protect the samplepump.
7.4.9 Gas measurements is in standby When the sample-tube and/or watertrap
mode has been replaced, press »Exp. CO2«
The »gas measurement is in standby mode« in order to restart the samplepump.
alarm is activated when the multigas module
goes to stand-by mode, where the sample-flow
pump is stopped.
Note:
The stand-by mode is activated if the status is
The water trap should be replaced
STBY or MANUAL, freshgas flow is closed
minimum every 3 months (multigas
and respiration rate is not detected, and this has
module type A) or every 1 month
been the situation for more than 10 min. This is
(multigas module type B).
done to increase the lifetime of the sample-flow
See section 4.1.4.
pump in the multigas module.

»Open freshgas flow or start ventilation to


activate« is shown as additional information.
7.4.11 Sampleflow rate error
When freshgas flow or ventilation is started, The »sampleflow rate error« alarm is given if
the multigas module is activated again, and the the sampleflow measured by the gasmodule is
measurement of gas concentrations is running not according to the specifications.
after app. 20 sec.
This could be caused by an obstruction in the
sample flow line.
7.4.10 Occlusion
The »occlusion« alarm is activated if the Check that the sample-tube between Y-piece and
multigas module cannot achieve a sample flow. water trap is not blocked. Replace if necessary.

Check that the sample-tube between Y-piece and Check that the water trap is not filled with
water trap is not blocked. Replace if necessary. liquid. Replace if necessary.

Check that the water trap is not filled with


liquid. Replace if necessary.
7.4.12 Invalid O2 sensor offset
The »invalid O2 sensor offset« alarm is given if
the sensor used for measurement of O2 cannot
be calibrated by the gasmodule.

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User Manual for SIESTA i TS

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.

7.4.14 Sample cell pressure out of range 7.5.2 Ventilator error


The »sample cell pressure out of range« alarm is An alarm is activated if a mal-function is
given if the pressure measured in the measuring detected in the electronics of the ventilator.
chamber inside the gasmodule is too high or to low
. There are 2 different types of ventilator error
This could be caused by an obstruction in the alarms:
sample flow line.
Ventilator out of order
Check that the sample-tube between Y-piece This alarm means that the ventilator is not
and water trap is not blocked. Replace if necessary. responding.

Dameca 7-9
User Manual for SIESTA i TS

Ventilator system failure Gas module RED service


This alarm means that the ventilator has If this alarm is activated, the gasmeasurement
detected a mal-function. data cannot be used. The type of error leading
to this alarm can only be corrected by a service
During these alarms, the ventilator will change technician.
to manual ventilation mode, and the patient
must be ventilated manually. Gas module out of order
If this alarm is activated, the gas module is not
functioning at all, and the gas measurement is
Note: not running.
The audible alarm cannot be disabled.

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:

Gas module YELLOW correctable


If this alarm is activated, the gas measurement
7.5.4 Machine closing down
data cannot be completely relied upon. The type The »machine closing down« alarm is activated
of error leading to this alarm can possibly be if the mains switch on front of the machine is
corrected by the user or the gasmodule. set to OFF position.

Gas module YELLOW service »Press mains switch to cancel« is shown as


If this alarm is activated, the gas measurement additional information.
data cannot be completely relied upon. The type
of error leading to this alarm can only be If the mains switch is not activated again, the
corrected by a service technician. machine will power down after approx. 20 sec.
If the mains switch is activated again within the
Gas module RED correctable approx. 20 sec., the machine will not power
If this alarm is activated, the gas measurement down, but continue to function as before.
data cannot be used. The type of error leading to
this alarm can possibly be corrected by the user
or the gasmodule.

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User Manual for SIESTA i TS

7.6 Overview of Alarms


Patient related alarms:
Alarm Factory set value Resolution Limits Priority Audible
disable
Airway 30 (x100 Pa) 1 (x100 Pa) 10-80 High Yes
pressure high (x100 Pa)
High MV exp STBY/MANUAL: OFF 0.1 L 0.1-80.0 L High Yes
VENT: 133 % of set MV and OFF
Low MV exp STBY/MANUAL: OFF 0.1 L 0.1-79.9 L High Yes
VENT: 66 % of set MV and OFF
PSV backup 30 sec. 5 sec. 10-40 sec. Low -
mode activated
Insp O2 High OFF 1% 19-100 % Medium Yes
and OFF
Insp O2 Low 18 % 1% 18-100 % High Yes
Insp O2 <
18 %: No
Exp O2 High OFF 1% 10-100 % Medium Yes
og OFF
Exp O2 Low 10 % 1% 10-100 % High Yes
Insp N2O High Fixed at 82 % High No
Insp CO2 High 3% 0.1 % 1-3 % og OFF Medium Yes
Insp CO2 Low OFF 0.1 % 1-3 % og OFF Medium Yes
Exp CO2 High 8% 0.1 % 0-15 % og OFF Medium Yes
Exp CO2 Low OFF 0.1 % 0-15 % og OFF Medium Yes
Insp AA High * 0.1 % 0-30 % Medium Yes
Insp AA Low OFF 0.1 % 0-30 % og OFF Low -
Exp AA High * 0.1 % 0-30 % Medium Yes
Exp AA Low OFF 0.1 % 0-30 % og OFF Low -
Resp rate High OFF 1 pr. min. 4-80 og OFF Medium Yes
Resp rate Low 4 1 pr. min. 4-80 og OFF Medium Yes
Apnea VENT: 20 sec. - - High Yes
MANUAL: 60 sec.
Secondary agent - - - Low -
identified
Ethanol detected - - - Low -
(multigas module type A only)

* 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 %

Dameca 7-11
User Manual for SIESTA i TS

System related alarms:

Alarm Priority Audible disable


Patient system disconnected Low -
Ventilator stopped due to patientsystem Medium Yes
disconnected
Absorber disconnected Low -
(during MANUAL or STBY)
Absorber disconnected (during VENT) High Yes
O2 flow is critical low Low -
O2 pressure is low High Yes
AIR pressure is low High Yes
N2O pressure is low High Yes
Electronic gasmixer fan stopped High Yes
O2 freshgasflow out of control High Yes
AIR freshgasflow out of control High Yes
N2O freshgasflow out of control High Yes
Electronic gasmixer battery low High No
External freshgasoutlet activated Low -
(during MANUAL or STBY)
Ventilator stopped due to external Medium Yes
freshgasoutlet activated (during VENT)
Emergency O2 flow activated High Yes
System pressure high High Yes
Disconnection High Yes
Drivegas low High Yes
Ventilator fan stopped High Yes
Ventilator battery low High No
System pressure High Yes
Pressure limit High Yes
Freshgas high High Yes
Ventilator mains power failure High Yes
Measured TV too high Low -
PSV backup mode activated Low -
Required insp. pressure is too low High Yes
Required insp. pressure is too high High Yes
Required insp. pressure is too close to High Yes
high press. alarm

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User Manual for SIESTA i TS

Alarm Priority Audible disable


Occlusion High Yes
Sample flow rate error High Yes
Invalid O2 sensor offset High Yes
Ambient CO2 too high Low -
Sample cell pressure High Yes
Gas measurement is in standby mode Low -
Mains power failure High Yes
Ventilator out of order High No
Ventilator system failure High No
Gasmodule out of order High Yes
Gasmodule yellow correctable High Yes
Gasmodule yellow service High Yes
Gasmodule red correctable High Yes
Gasmodule red service High Yes
Machine closing down Low -
(during MANUAL or STBY)
Machine closing down (during VENT) High Yes

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User Manual for SIESTA i TS

Left blank intentionally

7-14 Dameca
User Manual for SIESTA i TS

8. Maintenance and Cleaning


Before using the machine it must be cleaned and
washed according to the guidelines in this section.

8.1 Maintenance
Preventive maintenance of the machine must be
carried out at least once a year by an authorized
technician.

Daily maintenance carried out by the user


is limited to:

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.

Dameca 8-1
User Manual for SIESTA i TS

8.4 CO2 Absorber 8.5 Hoses, Y-piece and Manual


Breathing Bag
Clean, disinfect and dry hoses, Y-piece and
manual breathing bag in accordance with
normal hospital routines.

8.5.1 Routine cleaning


All the parts of the patient breathing system
can be washed in a washing machine.

8.5.2 After an infected case


Soak all parts of the patient breathing system
4 4 3 2 in a disinfectant. Then wash according to the
1
instructions for routine cleaning.

8.5.3 After cleaning


Check visually that all parts are totally dry,
undamaged and connected properly.
Pos Vare nr Beskrivelse An
qusjob42.11042.pdf

Fig. 8-2 CO2 absorber


Note:
If a re-usable CO2 absorber i-SORB is used Some disinfectants, such as phenol and
with the integrated patient breathing system, aldehyde compounds, can be absorbed
unscrew the lid of the absorber (2) and and accumulated in plastic and rubber
disassemble the components of the absorber parts, when disinfection has taken place
as shown in the figure. repeatedly.
Destroy the two filters (4) and the used
absorbent. Clean and sterilize as described
for the IBS patient system.

8-2 Dameca
User Manual for SIESTA i TS

8.6 Cleaning Methods


8.6.1 Washing machinery Note:
The washing machinery used must be construct- The lifetime of rubber parts can be
ed to allow the washing of instruments and extended considerably by avoiding
anaesthesia equipment. The washing programme decontamination and sterilization at
and detergents used must be suitable for was- high temperatures.
hing rubber and plastic parts. The washing
procedure should be finalized by rinsing in
clean water, heat disinfection and drying.
8.6.3 Autoclaving
After being washed, the parts can be autoclaved
Note: at 134OC for max. 7 min. a limited number of times
(app. 100 times).
The detergent shall have pH value
between 7 and 10 in final solution. 8.7 After Cleaning
Check that all components are in correct
Warning: condition and completely dry.
When handling the IBS body after Compressed Air can be used to remove residual
cleaning, beware of residual hot water water from the components.
in the internal channels. Apply a thin film of special grease(P/N 36825)
to the O-rings.
Reassemble the integrated patient breathing
8.6.2 Chemical disinfection system as follows:
Observe the manufacturer’s instructions
carefully. Disinfectants must be suitable
for the components for which they are used.
Do not expose components to disinfectants
for longer time than needed.
Rinse all components in sterile water after
disinfection and dry at room temperature.

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
User Manual for SIESTA i TS

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

8-4 Dameca
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8.8 Safety Control


After cleaning and sterilization, reassemble and verify proper function of the system.

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.

8.9 Parts for the CO2 Absorber

4 4 3 2
1

qusjob42.11042.pdf

Item Qty Description Part No.


1 1 Absorber 11042-02
2 1 Lid for absorber 11042-01
3 1 O-ring 36345
4 2 Filter (40 pcs.) 11040-40

Dameca 8-5
User Manual for SIESTA i TS

8.10 Parts for the IBS

Item Qty Description Part No.


1 1 Valve dome with O-ring 11890-40
2 2 Valve flap with seat 11890-31
3 1 Cover 51525-10
4 1 Membrane spill valve 51025-08
5 1 Bellows 11960-05
6 4 O-ring for APL valve 36252
7 1 O-ring for APL valve 36346
8 5 O-ring 36267
9 2 Gasket for absorber valves 11960-23
10 2 Gasket for absorber valves 11960-24
11 2 O-ring 36333-1630
12 1 Spring 11960-45
13 1 Spring 11960-25
14 1 O-ring 36333-1830
15 1 O-ring 36332-2020
16 1 O-ring 36332-2120
17 1 O-ring 36330
18 1 O-ring 36274
19 2 O-ring 36343
20 1 O-ring 36344

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qusjob42.11960serviceparts.pdf

Dameca 8-7
User Manual for SIESTA i TS

8.11 Consumables

Description Part no.

i-SORB single use absorber (box of 8 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11040-08


i-SORB re-usable absorber (1 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11042
Filter for re-usable absorber (40 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11040-40

Bellows for IBS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11960-05

Bacteria filter, single use (50 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38477-50

If external patient volume sensor is installed:


Spirometry tube 2 m (5 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42632-09
Spirometry tube 3 m (5 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42632-08
Spirometry tube 6 m (5 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42632-10
D-LITE Adult flow sensor, re-usable (1 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42632-06
PEDI-LITE flow sensor, re-usable (1 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42632-07

If external O2 fuel cell sensor is installed:


O2 sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42035-46
Cable for O2 sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10967-86
T-piece for O2 sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42012-07

If multigas module is installed:


Gas sample tube 2 m (10 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42630-01
Gas sample tube 2 m (100 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42630-100
Gas sample tube 3 m (10 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42630-02
Gas sample tube 3 m (100 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42630-200

Water trap (1 pcs.) for gasmodule A (lifetime: 3 months) . . . . . . . . . . . . . . . . . . . . . . . . 41020-25

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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User Manual for SIESTA i TS

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.

Auxiliary power outlets (optional):


Max. power from each outlet : 360 VA
Fuse for each outlet : T1.6A (230V) / T3.15A (115V)
Max. power total : 460 VA
Fuse for all outlets in total : T2A (230V) / T4A (115V)

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User Manual for SIESTA i TS

9.2 Gases

Note:
All gases and anaesthetic agents must conform to the European Pharmacopeia.

Central gas supply:


Inlet pressure : 4-6 (x100kPa) for O2, N2O and AIR
Spare Gas Supply (optional):
Pin index for 4 ltr cylinders (O2 and N2O).
Pressure gauges:
Central gas supply (optional) : 0-10 (x100kPa) for O2, AIR and N2O
Gas cylinder (optional) : 0-315 (x100kPa) for O2
0-100 (x100kPa) for N2O
Auxiliary outlets (optional):
Flow for O2 or AIR : 100 L/min at 4 (x100kPa) static pressure
140 L/min at 6 (x100kPa) static pressure
>300 L/min at 12 (x100kPa) static pressure
AGSS:
Scavenging flow : 30-40 L/min
Gas Alarm:
Alarm start-pressure for O2, AIR and N2O : 2.5 (x100kPa)
Auxiliary freshgas outlet (optional):
Max. pressure limiting valve : 90 (x100Pa)
Auxiliary O2 flowmeter (optional):
Flow range : 0 to 10 L/min
Accuracy : 7.5% actual flow + 2.5% full scale
Patient suction unit (optional):
Max. vacuum : -0.8 (x100kPa)
Max. suction flow : 35 L/min

9.3 Electronic Gas mixer


Set parameters:
Freshgas flow : 0.0, 0.3 to 20.0 L/min
Flow resolution : 0 to 1.0 L/min: 0.05 L/min,
1.0 to 20.0 L/min: 0.1 L/min
O2 set % : 21 to 100 % (O2/AIR mix)
25 to 100 % (O2/N2O mix)
O2 set % resolution : 1 % (v/v)
Accuracy : +/- 5 % (v/v)
O2 flow range : 0.0, 0.3 to 10.0 L/min
AIR flow range : 0.0, 0.1 to 10.0 L/min

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N2O flow range : 0.0, 0.1 to 10.0 L/min


Accuracy (all gases) : 0.1 to 0.5 L/min : +/- 50 ml
0.5 to 10.0 L/min: +/- 10 % of reading
O2 emergency flow:
Fixed flow : 5.0 L/min +/- 20 %

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 %

I:E Ratio : 3:1 and up to 1:9,9


PEEP : OFF, 4 to 20 (x100Pa)

Inspiratory pressure : 4 to 67 (x100Pa)


Inspiratory pause : 0 to 70 %

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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.

Airway pressure monitor


Measured parameters : PEAK, Plateau, Mean, PEEP, Compliance
(if vol. monitor is installed)
Pressure range : -10 to 99 (x100Pa)
Accuracy : +/-2 (x100Pa)
O2 % fuel cell monitor (optional):
Measuring range : 0 to 100 % O2 (V/V)
Accuracy : +/- 2 % O2 (V/V) at constant temperature and pressure
High O2% alarm : 19 to 100% and OFF
Low O2% alarm : 18 to 100%
Expected O2 sensor lifetime : Over 500.000 O2 percent hours under normal
conditions (equivalent to 33 months, when placed
in AIR at 25OC)
Cross interference : less than 1.25% O2 response to anaesthetic agents
Drift : less than 1% O2 over 24 hours
Rise time : less than 6 seconds for 90% of final value
Volume monitor (optional):
Measuring range Paed. sensor : 20 to 300 ml (insp./exp. flow: 2-35 L/min.)
Measuring range Adult sensor : 200 to 1500 ml (insp./exp. flow: 10-120 L/min)
Accuracy Paed. sensor : 20 to100 ml: +/- 10 ml
100 to 300 ml: +/- 10% of actual value
Accuracy Adult sensor : 200 to 500 ml: +/- 50 ml
500 to 1500 ml: +/- 10% of actual value

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High expired minute volume alarm : 0.1 to 80.0 L and OFF


Low expired minute volume alarm : 0.0 to 79.9 L and OFF

9.5 Integrated Breathing System


Dimensions:
Size : ø160 x 360 mm
Weight : 4 kg (complete system excl. i-SORB CO2 absorber)
APL valve:
Setting : SP, 5 to 75 (x100 Pa)
Accuracy : +-7 (x100Pa) at 4 L/min
i-SORB CO2 absorber:
Capacity : Approx. 900 gr.
Volume (empty) : 1420 ml

9.6 Multigas Module type A (see section 5.2) (optional)


Warm up time:
Time to match full specifications : 2 minutes after power up.

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

Gas measurement accuracy:


Breath rate 1 to 30 breaths pr. min:
O2 : +/- (2.5 % O2 + 5.0 % of actual reading)
N2O : +/- (1.5 % N2O + 5.0 % of actual reading)
CO2 : +/- (0.2 % CO2 + 5.0 % of actual reading)
Halothane : +/- (0.1 % HAL + 4.0 % of actual reading)
Enflurane : +/- (0.1 % ENF + 4.0 % of actual reading)
Isoflurane : +/- (0.1 % ISO + 4.0 % of actual reading)
Sevoflurane : +/- (0.1 % SEV + 4.0 % of actual reading)
Desflurane : +/- (0.1 % DES + 4.0 % of actual reading)
Ethanol : +/- 0.013 % Ethanol

Breath rate 31 to 60 breaths pr. min:


O2 : +/- 6 % O2
N2O : +/- (3.0 % N2O + 10.0 % of actual reading)
CO2 : +/- (0.4 % CO2 + 10.0 % of actual reading)
Halothane : +/- (0.2 % HAL + 8.0 % of actual reading)
Enflurane : +/- (0.2 % ENF + 8.0 % of actual reading)
Isoflurane : +/- (0.2 % ISO + 8.0 % of actual reading)
Sevoflurane : +/- (0.2 % SEV + 8.0 % of actual reading)
Desflurane : +/- (0.2 % DES + 8.0 % of actual reading)
Ethanol : +/- 0.025 % Ethanol

Cross-gas interference:
The multigas module will meet the specifications for accuracy, when the individual gases
are within the ranges specified in »measured parameters«.

Regarding cross-gas interference from Methane, Isopropanol or metered


dosed inhaler propellants, the following applies:

Methane : Up to 3000ppm Methane, the multigas-measurements will be


within specifications, except for measurement of Halothane
which may have an additional 0.1 % HAL in-accuracy.

Isopropanol : Up to 1000ppm Isopropanol, the multigas-measurements will


be within specifications, except for measurement of Ethanol
which may have an additional in-accuracy of up to 0.15 %
Ethanol.

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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.

Resp. rate measurement accuracy:


Resp. rate : +/- 2 breaths pr. min.
Resp.rate detection : 0.8% CO2 variation in measured CO2

Gas measurement typical response times 10 - 90 %:


O2 : max. 550 msec.
N2O : max. 300 msec.
CO2 : max. 300 msec.
AA : max. 500 msec. (once agent has been identified)
Ethanol : max. 150 msec.

Primary anaesthetic agent identification:


A primary anaesthetic agent will be identified by the multigas module, if the concentrations are
higher than:
Halothane : 0.20 % HAL
Enflurane : 0.20 % ENF
Isoflurane : 0.20 % ISO
Sevoflurane : 0.24 % SEV
Desflurane : 0.30 % DES

Secondary anaesthetic agent identification:


A secondary anaesthetic agent will be identified by the multigas module, if the concentrations are
higher than:

Halothane : 0.20 % HAL + 16 % of primary agent (ENF,


ISO, SEV or DES)

Enflurane :0.20 % ENF + 5 % of primary agent (HAL or ISO)


+ 6 % of primary agent (DES)
+ 10 % of primary agent (SEV)

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Isoflurane : 0.20 % ISO + 5 % of primary agent (HAL or SEV)


+ 6 % of primary agent (ENF)
+ 18 % of primary agent (DES)

Sevoflurane : 0.24 % SEV + 5 % of primary agent (HAL,


ENF or ISO)
+ 6 % of primary agent (DES)

Desflurane : 0.30 % DES + 8 % of primary agent (HAL, ENF,


ISO or SEV)

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 %

Exp. O2 % high : 10 to 100 % and OFF. Resolution: 1 %


Exp. O2 % low : 10 to 100 %. Resolution: 1 %

Insp. N2O high : Fixed 82 %

Insp. CO2 high : 1.0 to 3.0 % and OFF. Resolution: 0.1 %


Insp. CO2 low : 1.0 to 3.0 % and OFF. Resolution: 0.1 %

Exp. CO2 high : 0.0 to 15.0 % and OFF. Resolution: 0.1 %


Exp. CO2 low : 0.0 to 15.0 % and OFF. Resolution: 0.1 %

Insp AA high : 0.0 to 30.0 %. Resolution: 0.1 %


Insp AA low : 0.0 to 30.0 % and OFF. Resolution: 0.1 %

Exp. AA high : 0.0 to 30.0 %. Resolution: 0.1 %


Exp. AA low : 0.0 to 30.0 % and OFF. Resolution: 0.1 %

Resp. rate high : 4 to 80 breaths pr. min. and OFF


Resp. rate low : 4 to 80 breaths pr. min. and OFF

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9.7 Multigas Module type B (see section 5.2) (optional)


Warm up time:

Time to match ISO accuracy specs. : 45 sec. after power up

Time to match full accuracy specifications : 10 minutes after power up.

ISO accuracy specifications : As Full accuracy specifications but derated as follows:


Add +/- 0.3% CO2 to inaccuracy for CO2.
Add +/- 8% of actual reading to inaccuracy for
all anaesthetic agents.
N2O inaccuracy is +/- (2% N2O + 8% of actual
reading).
Water trap:

Capacity : 10 ml. (Adult) / 6 ml. (Neonate)

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.

Calculated parameters:

MAC : 0 to 10. Resolution: 0.1

Dameca 9-9
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Gas measurement accuracy (Full accuracy specs.):

Breath rate 1 to 60 breaths pr. min:

Gas Concentration1) [% REL] Inaccuracy2), 3) [% ABS] Interference4), 5) [% ABS]


0-1 ±0.1
1–5 ±0.2 N2O 0.1
CO2 5–7 ±0.3 O2 0.1
7 - 10 ±0.5 Any agent 0.3
> 10 Unspecified
CO2 0
0 – 20 ±2
N2O O2 0
20 - 100 ±3
Any agent 0
0 - 25 ±1 CO2 0.1
O2 25 - 80 ±2 N2O 0.2
80 - 100 ±3 Any agent 1.0
CO2 0
0-1 ±0.15
HAL, ENF, N2O 0.1
1–5 ±0.2
ISO O2 0.1
> 5 Unspecified
2nd agent 0.2 (typical)
0-1 ±0.15 CO2 0
1–5 ±0.2 N2O 0.1
SEV
5–8 ±0.4 O2 0.1
>8 Unspecified 2nd agent 0.2 (typical)
0-1 ±0.15
1–5 ±0.2 CO2 0
5 – 10 ±0.4 N2O 0.1
DES
10 – 15 ±0.6 O2 0.1
15 - 18 ±1 2nd agent 0.2 (typical)
> 18 Unspecified

Regarding cross-gas interference:

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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Resp. rate measurement accuracy:


Resp. rate 0-60 bpm : +/- 1 breath pr. min.
Resp. rate >60 bpm : Unspecified
Resp. rate detection : CO2 variation in measured CO2

Gas measurement typical response times 10 - 90 % (Adult water trap):


O2 : max. 500 msec.
N2O : max. 250 msec.
CO2 : max. 250 msec.
AA : max. 300 msec. (once agent has been identified)

Primary anaesthetic agent identification:


A primary anaesthetic agent will be identified by the multigas module, if the concentrations are
higher than:
Halothane : 0.25 % HAL (0.50 % during ISO accuracy mode)
Enflurane : 0.15 % ENF (0.40 % during ISO accuracy mode)
Isoflurane : 0.15 % ISO (0.40 % during ISO accuracy mode)
Sevoflurane : 0.15 % SEV (0.40 % during ISO accuracy mode)
Desflurane : 0.15 % DES (0.40 % during ISO accuracy mode)

Secondary anaesthetic agent identification:


A secondary anaesthetic agent will be identified by the multigas module, if the concentrations are
higher than:

Halothane : 0.30 % HAL (0.50 % HAL during ISO accuracy mode)

Enflurane : 0.30 % ENF (0.50 % ENF during ISO accuracy mode)

Isoflurane : 0.30 % ISO (0.50 % ISO during ISO accuracy mode)

Sevoflurane : 0.30 % SEV (0.50 % SEV during ISO accuracy mode)

Desflurane : 0.30 % DES (0.50 % DES during ISO accuracy mode)

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Alarms:
Insp. O2 % high : 18 to 100 % and OFF. Resolution: 1 %
Insp. O2 % low : 18 to 100 %. Resolution: 1 %

Exp. O2 % high : 10 to 100 % and OFF. Resolution: 1 %


Exp. O2 % low : 10 to 100 %. Resolution: 1 %

Insp. N2O high : Fixed 82 %

Insp. CO2 high : 1.0 to 3.0 % and OFF. Resolution: 0.1 %


Insp. CO2 low : 1.0 to 3.0 % and OFF. Resolution: 0.1 %

Exp. CO2 high : 0.0 to 15.0 % and OFF. Resolution: 0.1 %


Exp. CO2 low : 0.0 to 15.0 % and OFF. Resolution: 0.1 %

Insp AA high : 0.0 to 30.0 %. Resolution: 0.1 %


Insp AA low : 0.0 to 30.0 % and OFF. Resolution: 0.1 %

Exp. AA high : 0.0 to 30.0 %. Resolution: 0.1 %


Exp. AA low : 0.0 to 30.0 % and OFF. Resolution: 0.1 %

Resp. rate high : 4 to 80 breaths pr. min. and OFF


Resp. rate low : 4 to 80 breaths pr. min. and OFF

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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Classification according to EN 60601-1:

Class I Equipment : according to the type of protection against


electrical shock.
Type B Equipment : according to the degree of protection against
electrical shock.
Continuous Operation : according to the mode of operation

Classification according to EU Medical Device Directive 93/42/EEC:


The Dameca anaesthesia machine model Siesta i TS is classified as IIb

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10. Alphabetical Index

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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

Manufacturer Dameca a/s


Manufacturer’s address Islevdalvej 211 Phone : +45 44 50 99 90
DK-2610 Fax : +45 44 50 99 99
Rødovre E-mail: info@dameca.com
Denmark
EMC test hause Delta Denmark
Test rapport Certificate no: 686
Table 201
Guidance and manufacturer’s declaration – electromagnetic emissions
The AWS is intended for use in the electromagnetic environment specified below. The customer or the user of the AWS should
assure that it is used in such an environment.
Emissions test Compliance Electro
magnetic environment -guidance
RF-emissions Group 1 The AWS uses RF energy only for its internal function. Therefore, its RF
CISPR11 emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
RF-emissions Class A The AWS is suitable to use in all establishments other than domestic and those
CISPR11 directly connected to the public low-voltage power supply network that supplies
Harmonic emissions Class A buildings used for domestic purposes.
IEC 61000-3-2
Voltage fluctuations Complies
Flicker emissions
IEC 61000-3-3
Table 202
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 the AWS should
assure that it is used in such an environment.
Immunity test IEC 60601 AWS Electromagnetic environment -guidance
test level Compliance level
Electromagnetic ± 6 kV contact ± 6 kV contact Floors should be of concrete, wood or ceramic tile. If
discharge (ESD) ± 8 kV air ± 8 kV air floors are covered with synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30%.
Electrical fast ± 2 kV power supply lines ± 2 kV power Mains power quality should be that of a typical hospital
transient/burst ± 1 kV input/output lines supply lines environment
± 1 kV input/
IEC 61000-4-4 output lines
Surge ± 1 kV differential mode ± 1 kV differential Mains power quality should be that of a typical hospital
± 2 kV common mode mode environment.
IEC 61000-4-5 ± 2 kV common
mode
Power 3 A/m 3A/m Power frequency magnetic fields should be at levels
frequency characteristic of a typical location in a typical hospital
(50/60Hz) environment.
magnetic fields
IEC 61000-4-8
Voltage dips, >95% reduction for 10ms, >95% reduction for Mains power quality should be that of a typical hospital
short 60% reduction for 100ms, 10ms, 60% environment. AWS requires continuous operation during
interruptions 30%reduction for 500ms reduction for mains power interruptions.
AWS is equipped with internal batteries. The responsible
and voltage and >95% reduction for 5s. 100ms, organisation/user shall make sure that batteries are
variations on 30%reduction for replaced before their lifetime has expired, according to
power supply 500ms and >95% the instructions of use.
input lines reduction for 5s.
IEC 61000-4-11

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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

Radiated RF 3 V/m 10 V/m d= 0,35¥ P 80MHz to 800MHz


1EC 61000-4-3 80 MHz to 2,5 d= 0,7¥ P 800MHz to 2,5 GHz
GHz
Where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distances in metres (m).

Field strength from fixed RF transmitters, as determined by an


electromagnetic site survey,a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of equipment market with the
following symbol:

NOTE 1 At 80 MHz and 800MHz, the higher frequency range applies


NOTE 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection
from structure, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To asses the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the AWS is used exceeds the applicable RF compliance level above, the
AWS should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the AWS.
b Over the frequency range 150kHz to 80 MHz, field strengths shall be less than 10V/m.

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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

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