Siesta i TS 10650E-90 UK Apr08

8/10/2019 Siesta i TS 10650E-90 UK Apr08

1/114

User Manual

Dameca a/s

Islevdalvej 211

DK-2610 Roedovre, Denmark

Phone: +45 44 50 99 90, Telefax: +45 44 50 99 99E-mail: [email protected], www.dameca.com

SIESTAiTSAnaesthesia Machine

Software Version 3.0


2/114


3/114

User Manual for SIESTA i TS

Dameca I

Conformity according to the

Council Directive 93/42EEC

concerning Medical Devices.

Important !

We are constantly developing our products, and

consequently reserve the right to make alterations

in design and equipment without prior notice.

DAMECA a/s issues a guarantee against manu-

facturing and material defects for a period of

one year from the date of delivery. Excepted

from this guarantee are rubber articles and

anaesthesia valves with plastic parts.

DAMECA a/s will repair or replace all defective

components during the period of warranty, pro-

vided (1) that the unit has been used correctly in

accordance with the instructions for use and (2)

that the instructions for maintenance have beenobserved carefully.

Defective products or components must be

returned to DAMECA a/s with a detailed

description of the defect in question.

If repairs are carried out by anyone else than

DAMECA a/s or by a DAMECA a/s appointed

agent, the guarantee no longer applies.

Nobody but DAMECA a/s can issue any otherform for guarantee, either in writing or orally.

DAMECA a/s has no responsibility for any

translation of this English version of the manual.

Preventive maintenance of this unit should

be carried out at least once a year either by

DAMECA a/s or by an authorized technician.

Document No. 10650E-90

April, 2008

User Manual for Anaesthesia Machine

Model SIESTA i TS

Software Version 3.0


4/114


II Dameca

Left blank intentionally


5/114


Dameca III

Contents

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.2 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

1.3 Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

1.4 User Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

1.5 Responsibility of the Manufacturer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

1.6 Safety Features of the SIESTA i TS Anaesthesia Machine . . . . . . . . . . . . . . . . . . . . . . . 1-4

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

2.1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12.2 Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

2.3 Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

3. Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13.1 Anaesthesia Gas Scavenging System (AGSS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

4. Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.1 Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14.2 Function Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

4.3 Operation of Electronic Gas Mixer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

4.4 Operation of Stopwatch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18

4.5 Operation of Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

5. Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15.1 Respiration Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.2 Gas Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

6. User Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16.1 Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.2 Trend Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

6.3 Alarm Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

6.4 Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15


6/114


IV Dameca

Contents (continued)

7. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17.1 Integrated Breathing System Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

7.2 Electronic Gas Mixer Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

7.3 Ventilator Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

7.4 Multigas Module Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

7.5 System Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

7.6 Overview of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11

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

8.1 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

8.3 IBS Patient Breathing System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

8.4 CO2 Absorber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

8.5 Hoses, Y-piece and Manual Breathing Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

8.6 Cleaning Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

8.7 After Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

8.8 Safety Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

8.9 Parts for the CO2 Absorber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

8.10 Parts for the IBS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

9. Tehcnical Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

9.2 Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

9.3 Electronic Gas Mixer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

9.4 Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

9.5 Integrated Breathing System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

9.6 Multigas Module (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

9.7 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

9.8 Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1


7/114


Dameca 1-1

1. Introduction

This manual is related to EGM software

version 3.0, ventilator software version2.0 and multigas module (optional) software

version B7 or higher.

Damecaanaesthesia machine model SIESTAi

TS is applicable with most types of inhalation

anaesthesia. O2 and N2O, or O2 and AIR can

be administered, and anaesthetic vaporizer(s)

is connected to a back-bar.

The gas supply can be obtained from a centralgas supply system or from cylinders. There is

no difference in performance when supplied

from cylinders.

The machine is equipped with:

An electronic gas mixer (EGM) giving user

selectable gas mixes (O2/N2O or O2/AIR) in

a range of 0 20 L/MIN. If N2O is selected

as a mix to O2, the N2O percentage islimited to max.75% (minimum 25% O2).

A real time clock and a stopwatch is

included in the electronic gas mixer.

A microprocessor controlled anaesthesia

ventilator with user selectable ventilation

modes:

- VCV Volume Controlled Ventilation

- PCV Pressure Controlled Ventilation

- SIMV Synchronised Intermittent

Mandatory Ventilation

- PSV Pressure Supported Ventilation

An integrated breathing system (IBS)

where Bag in Bottle and patient re-breathing

system (incl. absorber) are integrated into

one block. Thereby there are only 2 tubes

(inspiratory and expiratory) from the IBS

system to the Y-piece.

An APL (Adjustable Pressure Limiting) valve

is integrated into the IBS, giving the usera choice between manual ventilation or

spontaneous breathing.

A multigas module (optional) which measures

respiration rate and inspired and expired

concentrations of O2 , N2O, CO2 and AA

(anaesthetic agent). The multigas module

has automatic identification of AA, as well as

identification of a secondary AA, if present.

The electronic gas mixer, ventilator and optional

gas module are all microprocessor controlled,

with software installed.

The machine can be equipped with various

additional equipment such as: Active scavenging system Transfusion stand Arm for patient monitor

Pin-index reduction valves for 4 L. gascylinders, or stand for 10 L. gas cylinders.

The design of the machine is very flexible towards

mounting of extra equipment and additional rails,

clamps etc. can easily be mounted on the machine.

1.1 Intended Use

The SIESTA i TS anaesthesia machine is inten-

ded for composition of anaesthetic breathing gas

and manual or automatic ventilation of patients

undergoing anaesthesia.

The SIESTA i TS anaesthesia machine is

intended for adult and paediatric patients.

Qualified anaesthesia personnel should operate

the SIESTA i TS anaesthesia machine only.

Before operating the machine mains electrical

power and pressurised gas must be connected

to the machine.

The machine is not MRI compatible.


8/114


1-2 Dameca

1.2 Description

The electronic gas mixer (EGM) of the SIESTA i

TS controls the freshgas flow given to the patientbreathing system. The EGM continuously mea-

sures this flow to assure that it is in accordance

with the setting made by the user.

Besides the EGM controls and displays data

from electronic gas mixer, ventilator and

optional multigas module on its 15 display,

which is touch controlled.

The ventilator of the SIESTA i TS uses

compressed AIR or O2 to ventilate the patientthrough the Bag in Bottle system, placed in

the integrated breathing system (IBS).

The ventilator continuously measures airway

pressure and inspired/expired volume (optional).

If a multigas module is not installed, the ventila-

tor can also measure inspired O2by means of a

fuel cell sensor (optional) placed on the inspira-

tory port of the patient breathing system.

The integrated breathing system (IBS) of theSIESTA i TS is a semi-closed patient breathing

system with one-way valves in both the inspira-

tory and expiratory limb, and an absorber for

eliminating CO2. The system is suitable for high

flow (app. the patient minute volume), medium

flow (app. 1-1.5 L/min) and low flow (app.

0.5-1 L/min) of freshgas for patient ventilation.

The IBS is a combination of a Bag in Bottle unit

and a patient re-breathing circuit. The IBS has

a standing bellows in order for the user to see

the controlled ventilation of the patient by the

movement of the bellows. Besides, in case of

a leakage, room air will not be drawn into the

system, and the leakage can be seen immediately

by the position of the bellows.

Integrated into the IBS is an APL valve which

is used for manual ventilation only.

The IBS uses a CO2 absorber i-SORB which

contains 900 gr. Sodalime. The absorber isavailable as a re-usable or a disposable version.

If the absorber is disconnected from the IBS,

two valves automatically close the connections

to the absorber, in order not to loose gases.

The multigas module (optional) of the SIESTA i

TS uses a gas sample from the Y-piece to mea-

sure inspired and expired concentrations of O2 ,

N2O, CO2 and AA (anaesthetic agent). Besides,the multigas module can detect if Ethanol or

Acetone is expired by the patient, and measure

the concentration. The multigas module has

automatic identification of AA.

If a secondary AA is present, the multigas

module also identifies this, and measures the

concentration.

When gas sample has been measured by themultigas module, it is re-introduced to the pati-

ent breathing system, on the expiratory side.

The multigas module does not require re-cali-

bration, as the calibration is stable for life-time.

The 3 pcs. integrated power outlets (optional)

of the Siesta i TS are separated from the mains

power by a transformer. This transformer

supplies isolated power to the power outlets.

See section 9 regarding power rating for the

power outlets.

Note:The parts of the SIESTA i TS do notcontain any latex.


9/114


Dameca 1-3

1.3 Performance

The electronic gas mixer of the SIESTA i TS is

designed to give a freshgas mixture selected bythe user of:

0 to 20 L/min O2 / N2O (O2 0-10 L/min,

N2O 0-10 L/min)

or 0 to 20 L/min O2 / AIR (O2 0-10 L/min,

AIR 0-10 L/min)

This flow is led through the vaporizer rail,

where anaesthetic agent can be added by meansof a user selectable vaporizer.

By activating an oxygen by-pass valve, approx.

45 L/min of O2 will be added to the freshgas

flow, after the vaporizer rail.

The SIESTA i TS has an integrated gas

scavenging system which removes excess

gases from an open reservoir. This system

must be connected to an AGSS power unit with

a flow of 30-40 L/min. If an external AGSS

power unit is not available, the SIESTA i TS

can be equipped with an integrated AGSS

power unit (optional).

The ventilator of the SIESTA i TS is designed

to give an inspiratory flow of:

Continous flow: 2 to 80 L/min Max. Peak flow: 120 L/min.

In VCV and SIMV mode the Tidal volume,Resp. rate, I:E ratio and Insp. pause user settings

are continuously controlled by the ventilator in

order to stay within the 2 to 80 L/min continuous

flow limits.

Inspiratory flow = Tidal volume x Resp. rate x

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

The integrated breathing system (IBS) of the

SIESTA i TS has an expiratory and inspiratoryresistance of:

60 L/min 30 L/min 5 L/min

Expiratory 4.5 2.0 0.3

resistance (x100Pa) (x100Pa) (x100Pa)

Inspiratory 4.5 2.0 0.3

resistance (x100Pa) (x100Pa) (x100Pa)

Compliance = 4 ml/hPa with adult tubings

(22mm diameter).

The CO2 absorber i-SORB of the integrated

breathing system (IBS) is designed to optimize

the flow through the absorber, so that all of the

sodalime is being used.

qusjob8.absorberkurver.tif

Note:

The SIESTA i TS contains batteries thatmust be exchanged by a technician atcertain intervals, as prescribed in theservice manual.


10/114


1-4 Dameca

1.4 User Setup

The SIESTA i TS can be set up to match user

preferences.

The following features can be installed when

the machine is manufactured:

Integrated patient suction Auxiliary freshgas outlet and integrated

auxiliary O2 flowmeter Multigas module 3 pcs. integrated power outlets

Extra O2 , AIR or VAC gas outlet 1 or 2 pcs. pin-index yokes for 4 L. gas cy-

linders or stand for 2 pcs. 10 L. gas cylinders Power unit for AGSS PSV accessible or not

The following parameters can be changed

after the machine has been manufactured:

Ventilator volume setting based on Tidal

volume or minute volume. SIMV accessible or not. If multigas module is not installed, oxygen

monitor based on external fuel cell sensor

can be activated or de-activated. Volume monitor can be activated or

de-activated.

If volume monitor is activated, the volume

measurement can be configured in two ways:

Only expired volume

If the volume monitor is configured to only

exp. volume, the volume sensor must be placed

at the expiratory port of the patient breathing

system. The volume monitor will then measure

the expired tidal- and minute-volume only.

Full spirometry

If the volume monitor is configured to full

spirometry, the volume sensor must be placed

at the Y-piece of the patient breathing system.

The volume monitor will then measure expiredtidal- and minute volume, inspired tidal volume

(during manual ventilation) and a pressure/

volume graph (spirometry loop) can be selected

by the user.

All these settings can be changed in the service-

menu, by a super-user or a technician.

1.5 Responsibility of the

Manufacturer

Dameca a/s is responsible for the effects on

safety, reliability and performance of the

equipment only if:

Personnel authorized by Dameca a/s

carry out assembly, operations, extensions,

re-adjustments, modifications, periodical

service or repairs.

The pneumatic installation of the relevant

rooms complies with appropriate requirements.

The equipment is used in accordance with

this user manual.

1.6 Safety Features of the SIESTAiTS Anasthesia Machine

Gas supply

O2, AIR and N2O supply failure alarm. Built-in

check valves to prevent reverse flow of gases.

The ventilator, patient suction (optional) and

AGSS power unit (optional) is powered by the

primary driving gas (AIR or O2 , normally AIR).

The optional patient suction can also be

powered by VAC (option).


11/114


Dameca 1-5

If the primary driving gas pressure is lost, a

driving gas valve automatically switches tothe secondary driving gas source (AIR or O2 ,

normally O2)

Electronic gas mixer

N2O cut-off if O2 supply fails.

Electronic O2/N2O ratio control (secures a

minimum of 25% O2 in an O2/N2O mix).

An MPL (Maximum Pressure Limiting) valveopens if the pressure of the freshgas flow to the

auxiliary freshgas outlet exceeds 90 (x100Pa).

Vaporizer rail

Back-bar for one or two vaporizers. The back-bar for two vaporizers is fitted with interlock

system to assure that only one vaporizer can

be activated one at a time.

Ventilator

A high-pressure alarm will automatically force

the ventilator into its expiratory state, avoiding

dangerous overpressure situations.

In addition the ventilator has a built-in pressurerelief valve which opens at 90 (x100Pa).


12/114


1-6 Dameca

Flow Diagram

qusjob42.SI1LW6~1.wmf


13/114


Dameca 2-1

2. Safety Precautions

Read this manual carefully and familiarizeyourself with the machine before you start

to operate the machine.

Always check the machine for proper function

before use.

A WARNING indicates a situation in which

the user or the patient may be in danger of

injury.

A CAUTION indicates a situation that may

lead to equipment damage or malfunction.

A NOTE indicates a point of particular interest

for more efficient and convenient operation.

2.1 Warnings

Do not open service hatches or covers. Nouser-serviceable parts inside the machine.

A qualified service technician should

perform service.

The machine must be connected to correct

grounded hospital grade electrical outlets

only.

Always unplug the electric power cord

before cleaning or maintenance of the

machine. Let it dry completely before

reconnecting it to the electrical outlet.

Spillage of liquids may cause electrical

shock.

Check that all cables are in good working

condition before connecting the machine

to mains or patient.

Do not use this machine in an environmentexceeding the EMC levels in EN60601-1-1-2.

External patient breathing systems used

with this machine must conform to EN740

or similar standard.

Bacterial filters used with this machine must

conform to EN 13328-1 or similar standard.

An anaesthetic vapour delivery deviceconnected to the machine shall comply

with ISO8835-4 or similar standard.

Heat and moisture exchangers used with this

machine must conform to EN ISO 9360 or

similar standard.

Humidifiers used with this machine must

conform to EN ISO 8185 or similar standard.

Suction units used with this machine

must conform to EN ISO 10079-1,

EN ISO 10079-2 and EN ISO 10079-3

or similar standard.

Medical gases and anaesthetic agents used

with this machine must conform to the

European pharmacopoeia.

Central gas supply used with this machine

must comply with EN737-1 or ISO7396 or

similar standard.

Note:If the central gas supply fails, theauxiliary gas outlet (optional) ofthis machine will also fail.


14/114


2-2 Dameca

A patient monitor connected to the patient

breathing system, may cause a leakage,

even if it is in stand-by mode.

The AGSS must be turned on whenever the

machine is in use.

Do not add, remove or modify any part of

the machine, unless authorised by Dameca a/s.

Explosion hazard

No oil or grease should be used in this

machine. This also applies to siliconebased lubricants and inflammable oil or

grease. Only PTFE based oxygen

compatible lubricants must be used,

(e.g. DAMECA special grease P/N 36825).

The machine is not suitable for use in the

presence of flammable anaesthetic agents

such as ether and cyclopropane. Only

anaesthetic agents complying with EN 740

or similar standards must be used.

Patient safety

Do not use the machine for a clinical

procedure without first ensuring that the

complete system is operating correctly.

If the multigas module of the Siesta i TS

is not installed, the machine should always

be used with a separate monitor for O2,

anaesthetic agent and CO2 concentrations.

This monitor must comply with the relevant

standards under the EU Medical Device

Directive.

If the volume monitor of the Siesta i TS is

not installed, the machine should always

be used with a separate monitor for expired

volume. This monitor must comply with

the relevant standards or the EU Medical

Device Directive

Ensure that all connections are secure and

check for proper operation of the machine

before use. In particular the patient breathing

system and O-rings should be checked toensure that connections are not loose, and

the patient breathing circuit is not leaking.

The use of antistatic or electrically condu-

ctive breathing tubes when utilizing high

frequency surgery equipment may cause

burns and is therefore not recommended

in any application of this machine.

Constant attention by a qualified individualis required whenever a patient is under

anaesthesia or connected to a ventilator.

Some malfunction of equipment requires

immediate action.

When using the ventilator, alternative means

for ventilating the patient must be present.

When operating the machine, an alternative

oxygen supply must always be present.

Use only the anaesthetic agent for which

the vaporizer is calibrated. Using the wrong

agent in the vaporizer can be fatal for patients.

If a re-usable CO2 absorber is used, the

following must be taken into account during

change of soda-lime: Soda-lime dust is

caustic and can produce burns in the respira-

tory tract if inhaled. Breathing protection

must be used to ensure that no soda-lime

dust is inhaled by personnel or patient.

Do not start any test procedure of the

electronic gas mixer or the ventilator with

a patient connected to the machine.

The test procedures are designed to ensure

correct and safe function of the machine.

Do not bypass the test procedures unless

patient safety requires an immediate starting

up procedure.


15/114


Dameca 2-3

Note:The auxiliary O2 flowmeter (optional)

is by-passing the MPL valve. The pres-sure from the flowmeter may exceedthe pressure from the freshgas outlet.

hetic gases in operating rooms. Observe

that the ball of the flowmarker is visible.

2.2 Cautions

Before connecting the power cord to the

electrical power supply outlet check that the

local voltage and frequency are as stated on

the TYPE label on the rear of the machine.

Do not attempt to connect other cables or

connectors to the auxiliary power outlets

(optional), than the ones intended for thispurpose.

Maximum load on side rails at table is

20 kg. Too much heavy equipment attached

at one side of the machine may cause the

machine to tilt.

Maximum total load on table plate

(including side rails) is 40 kg.

Maximum load on top plate is 40 kg.

Maximum torque on siderails is 20 Nm.

When closing the drawers of the machine,

observe that nothing gets squeezed or

damaged, with special attention to fingers.

Vaporizers used for Fluothane, Halothane or

other anaesthetic agents containing Tymol or

other stabilisers must be emptied every other

week, and the agent that is drained must be

destroyed.

Check calibration of vaporizers regularly

using a proper gas indicator (e.g.refracto-

meter or similar).

Authorised service personnel should service

this machine at least once a year.

Failure of operation

If the machine fails to respond as described,

do not use until qualified service personnel

have corrected the situation.

Occupational hazard

Do not use this machine in insufficiently

ventilated areas. Use scavenging system to

avoid increased concentrations of anaest-

The O2percentage in the patient circuit may

differ significantly from the O2percentage

of the freshgas.

When using soda lime in absorbers, follow

the manufacturers instructions.

If the machine has been used with different

anaesthetic agents, residues of these agents

(PPM) may still remain in the machine

(vaporizer rail etc.). By setting a high

freshgas flow during a long period of

time these residues can be minimized.

Means to avoid cross infection between

patients must be used. See section 8

regarding maintenance and cleaning.

When connecting more than one external

equipment to the auxiliary power outlets

(optional), a high leakage current from one

equipment (f.ex. in case of a defective earth

conductor) will affect the leakage current

from the other equipment.


16/114


2-4 Dameca

2.3 Symbols

Type B (EN60601-1) protection

against electrical shock.

Attention, consult accompanying

documents.

Adjusment for auxiliary O2 or

patient suction:

Turn counter-clockwise to increase.

Turn clockwise to decrease.

ON/OFF switch for lamp.

Protective earth.

Equipotentiality.

ON/OFF

WEEE Symbol, meaning that the

electronics must not be regarded

as normal waste.

Note:Tubings used with this product must fulfill the EN12342 standard, andrespiration bags must fulfill the EN1820 standard.

Vaporizers should be serviced according

to the manufacturers instructions by an

authorised service centre.

Use only original DAMECA hoses and

accessories; other hoses and accessories

may cause malfunctions.

Use only original DAMECA O-rings;

other O-rings may cause problems if they

are not of the same size or material.

Do not leave spare cylinder valves open

when using the machine on central gas

outlets.

Pressure from cylinders may be higher than

the pressure from central outlets, and the

cylinder supply could be depleted.

Disconnect the machine from mains and

medical gas supply, when not in use, to

prevent pollution.


17/114


DamecaDameca 3-1

3. Function

Fig. 3-1 Anaesthesia machine model SIESTA iTS front view

1. Castors with brake

2. Drawers

3. AGSS ON/OFF (option) and flow marker

4. Auxiliary oxygen flowmeter outlet

(optional)

5. Auxiliary freshgas outlet (optional)

6. CO2 absorber

7. Lock for absorber

8. BAG connection

9. APL valve (for manual ventilation only)

10. Bellows

11. O2

flush

12. Water trap for multigas module (optional)

13. Transfusion stand (optional)

14. Top shelf

15. Main switch

16. 15 TFT colour touch screen

17. Control wheel

18. ON/OFF switch for light

19. Emergency flow switch

20. Back-bar for two interlock vaporizers

21. Integrated auxiliary oxygen flowmeter

(optional)

22. Table with integrated rails

23. Integrated patient suction (optional)

24. Auxiliary freshgas outlet switch (optional)

qusjob42.10653 front.png

5

10

2

1

1215

17

22

20

1

13

24

11

8

6

14

16

3

7

9

21

23

1819

IBS

4


18/114


3-2 Dameca

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

1. Castors without brake

2. Lower fan

3. Yokes for spare cylinders (optional)

4. Grounding point

5. Mains power inlet switch

6. Mains power cord

7. Connections for patient flow sensor

(optional)

8. Auxiliary gas outlet (optional)

9. Auxiliary AGSS connection

10. RS232 port

11. Auxiliary power outlets (optional)

12. Upper fan

13. Gas inlets

14. Insp./Exp. connections for patient

breathing system

15. Lock for patient breathing system

16. Patient suction connection (optional)

17. Connection for optional O2 fuel cell

sensor

qusjob42.10653 bag.png

11

2

13

10

1 1

7

15

14

16

12

65

4

3

8

9

17


19/114


DamecaDameca 3-3

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

Flow (L/min)O2 N2O

1.00 2.00

Rotameter

Freshgas flow(L/min)

3.00

O2set %

33

Adult sensor At Y-piece Peak

17

Plateau

17

PEEP

3

Compl. 34 ml/hPa

hPa

0

20

40

%

0

2

4

Stop watch

00:00:00

Cancel

alarms

Alarm

menu

Trend

menu

Setup

menu

Normal

screen

Vent. mode

VCV

Status

VENT

Exp CO2

1.8Insp CO2

0.1

Resp. meas.

MVexp(l)5.8

Exp

TV(ml) 480

RR(1/min)12

8.04.0

OFF4

Gas meas. (%)

Exp Insp

O2 32 33

N2O64 63

SEV0.4 0.6

MAC 0.4(age: 40)

PSV settings

30

TV set(ml)

500

RR set(1/min)

12

PEEP(hPa)

OFF

I:ERatio

1:2

P Insp(hPa)

(17) More settings

EGM 5.0 Thursday 6. December 11:13

Touch screen controlled Selftest bypassed

qusjob42.Fig. 3-3 with gasmodule.pdf

1. Window for set freshgas flow

2. Window for measured freshgas flow

3. Window for set O2 percentage in

freshgas flow

4. Window for set total freshgas flow

5. Window for alarms and messages

6. Window for date and real time

7. Window for measurement of CO2concentrations

8. Window for measurement of gas

concentrations

9. Window for stopwatch

10. Window for activating normal screen

11. Window for activating setup menu

12. Window for activating trend menu

13. Window for activating alarm menu

14. Window for activating cancel alarms

15. Window for measurement of respiration

data (optional)

16. Window for machine status VENT/

MANUAL/STBY)

17. Window for ventilation mode

18. Window for more ventilator settings

19. Window for PSV settings (optional)

20. Window for set inspiratory pressure

21. Window for set PEEP

22. Window for set I:E ratio

23. Window for set respiration rate

24. Window for set tidal volume

25. Window for respiratory graph,

pressure measurements and

high alarm setting.

13

6

23

4

3

2

1

5 7 98

10

11

12

14

15

22 21 20 19 1824 17

16

25


20/114


3-4 Dameca

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

1. Window for set freshgas flow

2. Window for measured freshgas flow

3. Window for set O2 percentage in

freshgas flow

4. Window for set total freshgas flow

5. Window for alarms and messages

6. Window for date and real time

7. Window for respiratory graph, pressure

measurements and high alarm setting

8. Window for measurement of inspired

O2 percentage (optional)

9. Window for stopwatch

10. Window for activating normal screen

11. Window for activating setup menu

12. Window for activating trend menu

13. Window for activating alarm menu

14. Window for activating cancel

alarms

15. Window for measurement of

respiration data (optional)

16. Window for machine status

(VENT/MANUAL/STBY)

17. Window for ventilation mode

18. Window for set inspiratory pause

19. Window for PSV settings (optional)

20. Window for set inspiratory pressure

21. Window for set PEEP

22. Window for set I:E ratio

23. Window for set respiration rate

24. Window for set tidal volume

Flow (L/min)O2 N2O

1.00 2.00

Rotameter


3.00

O2set %

33

hPa

0

20

40

Stop watch

00:00:00

Cancel

alarms

Alarm

menu

Trend

menu

Setup

menu

Normal

screen

Vent. mode

VCV

Status

VENT

Resp. meas.

MVexp(l)5.8

Exp

TV(ml) 480

8.04.0

PSV settings

30

TV set(ml)

500

RR set(1/min)

12

PEEP(hPa)

OFF

I:ERatio

1:2

P Insp(hPa)

(17) More settings

EGM 5.0 Thursday 6. December 11:13

Touch screen controlled Selftest bypassed

O2meas. %

32

Adult sensor At Y-piece

Peak

17

Plateau

17

PEEP

3

Compl. 34 ml/hPa

qusjob42.fig. 3-4 without gasmodule.PDF

13

6

23

4

3

2

1

5 7 98

10

11

12

14

15

22 21 20 19 18 17

16

24


21/114


DamecaDameca 3-5

3.1 Anaesthesia Gas Scavenging System (AGSS)

The Siesta i TS anaesthesia machine has a

built-in scavenging system. This systemrequires evacuation flow of 30-40 L/min.,

in order to remove excess gases from the

integrated patient breathing system to the

AGSS outlet on the rear of the machine.

The evacuation flow can be generated by the

permanent gas installation in the operating

room, or it can be generated by an air driven

ejector in the Siesta i TS machine, activated

with an ON/OFF switch located at left side ofthe machine, next to the AGSS flow marker.

A built-in reservoir in the scavenging system is

open to the ambient air and serves as a relief ofthe ejector vacuum.

An AGSS connector on the rear of the machine

is for connection of the machine to the central

scavenging system.

Warning:The gases and agents used underanaesthesia can pose a danger ifAGSS is not active, or the operatingroom is not ventilated properly.

Fig. 3-5 Flow marker

The air driven ejector is optional.

An AGSS flowmarker at left side of the

machine contains a yellow ball which is

visible when the flow is 25 L/min or more.

qusjob33.flowmark.pcx

Note:The AGSS flowmarker is for the IBS(Integrated Breathing System) only.If an external breathing system isused, this system must be equippedwith an indicator for the AGSS flow.

3.1.1 External Breathing System

If an external breathing system is used with the

machine (see section 4.1.3), the excess gases

from this system can be removed by connecting

it to the auxiliary AGSS connection on rear sideof the machine (9 on fig. 3-2).

Remove the plug from the auxiliary AGSS

connection (30 mm female cone) and connect

the external breathing system.

Warning:The external breathing system must

have an open reservoir integrated intothe AGSS part of the system.Otherwise the auxiliary AGSS flowcan create a sub-atmospheric pressurein the external breathing system,which can be dangerous to the patient.

When an external breathing system is no longer

used with the machine, re-mount the plug on the

auxiliary AGSS connection (30 mm female cone).


22/114


3-6 Dameca

Left blank intentionally


23/114


DamecaDameca 4-1

4. Operation

Note:Before using the machine the first timeit must be electrical safety testedaccording to EN 60601-1, and all

patient related parts must be cleaned.

Note:Before connecting the machine to a

patient, a function test must be carriedout as described in section 4.2.

Note:Check voltage rating on the type labelat the rear panel of the machine,

before connecting it to the mains.

4.1 Set Up

Connect the machine to the mains.

Connect the machine to the pressurised

gases (400 - 600 kPa), vacuum (optional)

and AGSS. Activate AGSS flow and check that the yellow

ball in the flow marker (3 on fig. 3-1) appears.

The AGSS flow can be generated by the

machine (optional) or by a unit in the AGSS

installation of the hospital. If the AGSS flow

must be generated by the machine, it can

be activated by pressing the red/green pin

placed above the flow marker (3 on fig. 3-1).

4.1.1 Integrated breathing system

Assemble the integrated breathing system

(see section 8), connect it to the base (1)

and lock it by using the handle (2). Connect i-SORB CO2 absorber (5) to the

integrated breathing system, by placing

it into the bracket underneath the base

and pulling up, until the lock clicks.

Caution:If a disposable i-SORB CO2 absorber is

used with the system, the seal on a newabsorber must be removed, before theabsorber is connected to the integrated

breathing system.

qusjob42.10653-00 slange.pdf

2

1

5

4

3

6


24/114


4-2 Dameca

Connect inspiratory and expiratory hoses

(3) to the connections marked INSP and

EXP on the integrated breathing system,

including Y-piece (4) and bacteria filter(P/N 38477). The bacteria filter can be

placed at the Y-piece or at the expiratory

connection of the IBS system. Connect manual respiration bag (6) to the

connection marked BAG on the integrated

breathing system. A hose can be placed

between BAG connection and respiration

bag to give better flexibility for the user.

Note:

If an i-SORB CO2 absorber is notreinserted within 30 sec., a messagewill be shown on the display:Absorber disconnected.

If the ventilator is in automaticventilation mode, this messagewill be followed by an alarm.

21-12-200409:47

qusjob42.10653ny.pdf

Note:The integrated breathing system mustnot be changed during use.

If the integrated breathing system isdisconnected, a message will beshown on the display:

Patientsystem disconnected.

If the ventilator is in automaticventilation mode, this messagewill be followed by an alarm.

Note:The respiration bag must be 1-3 L.otherwise the leakage test of theBAG system, included in the selftest,may not work correctly.

Set the freshgas switch (24 on fig. 3-1) to

Circle System.


25/114


Dameca 4-3

4.1.2 Changing the CO2 absorber

4.1.3 External breathing system

Other breathing systems than the integrated

breathing system can be used with the

Siestai TS anaesthesia machine.

Assemble the breathing system and connect

it to the auxiliary freshgas outlet (optional)

placed at left side of the writing table

(5 on fig. 3-1)

PUSH

Remove sealon new absorber.(disposable ver.)

"CLICK"

qusjob42.11960uds ab.pdf

1. Take the handle of the absorber.

2. Push the knob above the handle of the

absorber to release it. The two absorber

valves will close in order to prevent loss

of gases during change.

3. Lift the used absorber out of the bracket.

4. Put the fresh absorber into the bracket.

5. Lift the handle until the lock gives a click.

6. The absorber is now attached to the patientsystem.

Caution:A bacteria filter should always be usedwith the integrated breathing system.Dameca bacteria filter P/N 38477-50(50 pcs.) can be used.

In order to remove excess gases from the

breathing system, connect it to the to 30 mm

female cone marked AUX AGSS on the

rear of the machine (9 on fig. 3-2).

See section 3.1.1

Set the freshgas switch (24 on fig. 3-1)

to Aux Outlet.

21-12-200409:47

qusjob42.10653ny.pdf


26/114


4-4 Dameca

Caution:If the ventilator is in automaticventilation mode, when the freshgasswitch is set to Aux Outlet, theventilator will stop and an alarmwill start: Ventilator stopped due toexternal freshgasoutlet activated.

4.1.4 Multigas module water trap

If an integrated gas module is installed, the water

trap (12 on fig. 3-1) must be installed prior to use.

Make sure the water trap is not filled with water,

and install it on the base on left side of the machine.

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

replaced (P/N 41020-25).

The capacity of the water trap is 22 ml.

Attach a sample tube between the water trap and

the Y-piece, for example via a bacteria filter.

The sample tube must be 2 to 3 metres long and

have an internal diameter of at least 1.2 mm.

Dameca sample tube P/N 42630-100 (100 pcs.,

2m) or P/N 42630-200 (100 pcs., 3m) can be

used.


17

Plateau

17

PEEP

3

Compl. 34 ml/hPa

hPa

0

20

40

30

PEEP(hPa)

I:ERatio

P Insp(hPa)

Note:

When the freshgas switch is set toAux Outlet, a message will beshown on the display: Externalfreshgasoutlet activated. In thissituation the patient can only beventilated manually, as the ventilatorcannot be activated.If the user tries to activate the ventilator,a message will be shown on the display:Cannot start ventilator when external

freshgasoutlet is activated.

4.1.5 Patient volume sensor

The machine can be set up with volume monitor

(15 on fig. 3-3 or 15 on fig. 3-4), which uses a

flow sensor.

The machine uses two different flow sensors:

Paediatric flow sensor is used for patients with

tidal volume from 20 to 300 ml (insp./exp. flow

2-35 L/min.).

Adult flow sensor is used for patients with tidal

volume from 200 to 1500 ml (insp./exp. flow

10-120 L/min.).

If the flow sensor is placed on the expiratory

side, the expired tidal volume and minute

volume are measured.

If the flow sensor is placed at the Y-piece, the

inspired tidal volume is also measured, and a

spirometry-graph (pressure, volume) can be

shown on the main display.

In the service menu a super-user or a technician

can define the default value for placement of theflow sensor.

In the spirometry-menu the user can change the

placement of the flow sensor. However the ma-

chine will always go back to default value, after

selftest or when the machine is powered off.

If the flow sensor is placed at the Y-piece, be

sure to place the sensor with the PATIENT

port facing the patient.


27/114

External flowsensor kit P/N 10967-120

Item Qty Description Part No.

1 1 Spirometry tube 2 m 42632-091

2 1 Adult flow sensor, Re-usable 42632-06

3 1 Paed. flow sensor, Re-usable 42632-07

4 2 Single-use bacterial filter. 38477

1

42

3

qusjob41.10967-120.pdf

Patient port

Caution:After selftest has been performed, the type of flow sensor (Adult/Paediatric)must be defined in the setup menu.


Dameca 4-5

The actual settings for the flow sensor (type and placing) are shown in the window for respira-

tion graph. If flow sensor type and placing are not shown, this means the machine is installed

without any flow sensor.

Note:A bacteria filter must always be placed between the patient and the flowsensor.

If the external flow sensor is used, tubings between flow sensor and connectors (7 on fig. 3-2)

on the machine must be connected.


28/114

4.1.6 O2 fuel cell sensor

If an integrated gas module is not installed, the

machine can be set up with an O2 monitor (8 onfig. 3-4), which uses an external fuel cell sensor.

Then the main display will look like the

following:

Place the O2 sensor on T-piece

(P/N 42012-07) in the patientbreathing system on the inspiratory

side. The O2 sensor must always face

upwards.

Connect cable between O2 sensor and

connector (17 on fig. 3-2) on rear panel

of the machine.


4-6 Dameca

Stop watch

00:00:00

Setup

menu

Normal

screen

:13

ed

O2meas. %

32

O2 Sensor kit P/N 10967-85

Item Qty Description Part No.1 1 T-piece 42012-07

2 1 Oxygen sensor 42035-46

3 1 Cable for oxygen sensor 10967-86

2

1

3

qusjob41.10967-85.pdf


29/114


Dameca 4-7

4.2 Function Test

Turn on the mains power inlet switch on

rear side of the machine (5 on fig. 3-2).

If the main switch on front of the machine is set

to ON during this period, the message will dis-

appear and the machine will continue to function.

If the main switch on front of the machine is NOT

set to ON position during this period, the ma-

chine will power off when the period has ended.Note:When the mains power switch onrear side of the machine is turnedon, the batteries inside the machinewill be charged at all times, inde-

pendent of whether the machine isrunning or not. Therefore this switchshould be set to ON at all times.

Push the main switch on front of the machine

(15 on fig. 3-1) to set it to ON position.

Note:If a mains failure alarm is givenwhen the main switch on front ofthe machine is set to ON position,this is most likely caused by themains power inlet switch on rear sideof the machine not being set to ON.

Note:

When the main switch on front ofthe machine at a later time is pushedin order to set it to OFF position, amessage will be shown on the screen:Machine closing down. Press ma-ins switch to cancel. Now a powerdelay period of app. 20 seconds isstarted. During this the machinewill continue to function as before.

Note:The integrated breathing system must

be assembled and connected, incl. hoses,Y-piece and i-SORB CO

2

absorber, be-

fore a function test can be carried out.

Warning:The patient must not be connected tothe machine at power-up or duringthe functional test.

Now the machine will power up and perform an

initial self-test checking the internal system for

safe condition and performing test sequence 1.

This takes approx. 1 minute.

Note:

If the machine is equipped with an inte-grated multigas module, this modulewill not be working until approx. 2 min.after activating the main switch on front

panel. If the machine is equipped withan O2 monitor which uses an external

fuel cell sensor, this monitor will not beworking until approx. 1 minute afteractivating the main switch on front panel.


30/114


4-8 Dameca

When the initial self-test has been successfully

completed, the machine is in Stand-by mode

and the full selftest can be performed.

4.2.1 FULL self test

During the FULL selftest the machine checks

its functions, measures the compliance of the

system and checks for leakages. The compliance

and leakage test includes the integrated breathing

system incl. hoses and Y-piece.

When the mains switch (15 on fig. 3-1) is set to

ON by the user, the machine automaticallyperforms test sequence 1 to ensure the correct

function of its mandatory components. Then test

sequence 2 is activated.

Test sequences:

Start-up

Display: Do you want to perform FULLTEST: Y/N

Patient must NOT be connected

during test

Select Y or N and press to continue

Change between Y and Nby turning the

control wheel, and press enter to select. By selecting Y the FULL selftest is started.

By selecting N the FULL selftest is bypas-

sed. This should only be done in case of anemergency.

Even if the FULL selftest has been started, the

user can bypass the test by pressing the normal

screen field (10 on fig. 3-3), and the following

text will be shown:

Display: Do you want to bypass selftest:

Y/N

Only bypass in case of anemergency



control wheel, and press enter to select. By selecting Y the FULL selftest is bypas-

sed. This should only be done in case of

an emergency. By selecting N the FULL selftest is started

again from the beginning.

Warning:If the FULL selftest is bypassed, someof the functions of the machine willnot be checked. The user must thenincrease observation of the patientduring anaesthesia, in order to

maintain a safe function.

Note:During the full selftest all alarmsare disabled.

Note:If a system related alarm (see section 7)is detected after power-up of themachine, the selftest is not started.Instead the alarm is shown on thedisplay. When the alarm is no longeractive, press cancel alarms and theselftest will start.

When FULL TEST is selected by the user

(by selecting FULL TEST in the selftest

menu, included in the setup menu, and pressing

the control wheel), start-up sequence is

activated before going to test sequence 1.


31/114


Dameca 4-9

Warning:

If the FULL selftest is bypassed, thecompliance and leakage of the integra-ted breathing system are not measured.The ventilator therefore uses the datafrom last selftest, and therefore the settidal volume in VCV mode might not

be correct.

Note:If the FULL selftest has been bypassed,the text SELFTEST BYPASSEDis shown constantly on the main display.

Warning:The patient must not be connected tothe machine during the FULL selftest.

2. Gasmixer test

Display: Occlude Y-piece (use testadapter).

Check gas evacuation (flow marker)Set APL valve to 35 hPa

Open vaporizer

Press to start

If you want to leave this test, press

normal screen

Place the Y-piece on the test plug at the BAG

connection of the integrated breathing system.

Check the yellow ball in the flow marker

(3 on fig. 3-1) is visible.

Set the APL valve in patient breathing system

(9 on fig. 3-1) to 35 hPa, and open the vaporizer.

Press the control wheel to confirm.

Display: Electronic gas mixer test is running

The functionality of the electronic gasmixer

is checked.

Warning:

The FULL selftest must be carriedout at least one time per day, whenthe machine is in use.

1. System and valves

Display: System check running

The internal safety system of the machine

(watchdog) and the valves for the electronic

gasmixer and the valves for the ventilator

are checked during this.

Note:If the machine is setup with a separate

patient monitoring device with measure-ment of gas concentrations, and thesample flow is not returned to the

patient system, the tube for sample flowmust not be connected to the patientsystem during the test. Otherwise theleakage will be too high.

3. Filling of BAG

Display: Leakage test of system is running

The electronic gas mixer generates a flow

of 10 L/min O2 and 9.75 L/min AIR for

10 seconds to fill the respiration bag.

After this, the airway pressure in the patient

system is checked (should be 25 to 45 hPa).


32/114


4-10 Dameca

4. Compliance and leakage, VENT

Display: Leakage test of system is running

The electronic gas mixer generates a flow of

10 L/min O2 and 9.75 L/min AIR for 10 seconds

to fill the bag in the Bag in Bottle system.

After this the electronic gas mixer generates

a flow of 5 L/min O2 and the pressure in the

patient system is checked (should be 1.5 to

4.5 hPa due to Bag in Bottle).

Then the compliance of the VENT system ismeasured, based upon the volume required from

the ventilator to reach a 30 hPa pressure

in the patient system.

This 30 hPa pressure must be reached within

10 sec. at an inspiratory flow of 5 L/min., or an

error message will be shown on main display.

The compliance of the system must be from

2.0 to 10.0 ml/hPa, or an error message willbe shown on main display.

When the 30 hPa pressure is reached, the

leakage of the VENT system is measured, based

upon the pressure drop during time, taking into

account the compliance of the system.

If the pressure drops too fast for the leakage to

be measured, an error message will be shown on

main display:

Display: Leakage too high

Check BiB, connectors and hoses

Press to repeat test

When the control wheel is pressed, the compli-

ance and leakage test will be performed again.

If the leakage is more than 100 ml/min but

less than 1000 ml/min, an error message will

be shown on main display:

Display: Leakage in VENT system XXX

ml/min. Accept: Y/N


Select N to repeat test. Select Y tocontinue


control wheel and press enter to select. By selecting Y the measured leakage is

accepted, and the next test sequence will

be performed. By selecting N the measured leakage is not

accepted, and the compliance and leakage

test will be performed again.

If the leakage is more than 1000 ml/min, an

error message will be shown on main display:

Display: Leakage in VENT system XXX

ml/min.



When the control wheel is pressed, the compli-ance and leakage test will be performed again.

5. Leakage, BAG

The BAG/VENT valve in the integrated

breathing system is set to BAG and the

pressure in the patient system is measured

to detect possible leakage from the APL valve

or the respiration bag. If the pressure has

dropped to a value below 10 hPa, an error

message will be shown on main display:

Display: Leakage in BAG system too high

(pressure below 10 hPa)

Check APL valve and resp. bag

(empty ?)


When the control wheel is pressed, the compli-

ance and leakage test will be performed again.


33/114


Dameca 4-11

6. Leakage, BAG/VENT, exp. valve

and peep valve

Display: Set APL valve at pat. circuit toSP. Close vaporizer

Press to continue

Set the APL valve to SP and close the vaporizer.

Press the control wheel to confirm.

Display: Valve check running

When a 30 hPa pressure is reached on the

outside of the bellows of the Bag in Bottle,with the BAG/VENT valve in BAG position,

the leakage from the BAG/VENT valve and

from the expiration and peep valves inside the

ventilator is checked based upon the pressure

drop during time.

If the pressure drop is too high the ventilator

gives an error message:

Display: Leakage in BiB system too highCheck BiB and change-over valve


When the control wheel is pressed, the leakage

test for the BAG/VENT valve and the expiration

and peep valves inside the ventilator will be

performed again.

7. Test completedDisplay: Leakage in VENT system: XXX

ml/min

Compliance in VENT system: X.X

ml/hPa

Press to continue

When the control wheel is pressed, the next text

appears on the display:

Display: Refreshing gases in patient system

The electronic gasmixer generates a flow of 10L/min O2 and 9.75 L/min. AIR for 10 seconds to

remove any anaesthetic agent from the patient system.

Then the nex text appears on the display.

Display: Check alarm sound present

Press cancel alarms to confirm

Check that the alarm sound is present, and press

cancel alarms. Then the next text appears onthe display:

Display: Test completed. Check pat.

suction, vaporizer etc.

Adjust APL valve

Remove Y-piece from test adapter

If vol. monitor is installed, sensor

must be connected and defined

Read user manual

Press to finalize

The APL valve should be adjusted as

desired by the user. Y-piece should be removed from the testadapter If the machine is set-up with volume monitor,

the type of sensor (Adult or Paediatric) must

be defined in the setup menu by the user. When the control wheel is pressed, the

machine goes to STBY mode and all user

settings are set to default values. Then the manual part of the selftest should

be performed, as described in section 4.2.3 to

4.2.15

4.2.2 LC self test

The LC (Leakage and Compliance) test can be used

for measuring compliance and checking for leak-

age if parts of the patient system (f. ex. hoses and

respiration bag) have been changed between two

patients.


34/114


4-12 Dameca

During the LC selftest the compliance of the

system is measured, and the leakage is checked.

The compliance and leakage test includes the in-

tegrated breathing system incl. hoses and Y-piece.

When LC TEST is selected by the user (by

selecting LC TEST in the selftest menu,

included in the setup menu, and pressing the

control wheel), the following test sequences

are activated.

Change between Y and N by turning the

control wheel, and press enter to select. By selecting Y the LC selftest is bypassed.

By selecting N the LC selftest is startedagain, from the beginning.

Note:During the LC selftest all alarmsare disabled.

Test sequences:

Start-up

Display: Do you want to perform LC TEST:

Y/N

Patient must NOT be connectedduring test



control wheel, and press enter to select. By selecting Y the LC selftest is started. By selecting N the LC selftest is bypassed.

Even if the FULL selftest has been started, the

user can bypass the test by pressing the normal

screen field (10 on fig. 3-3), and the following

text will be shown:

Display: Do you want to bypass selftest:

Y/N

Only bypass in case of an

emergency

Select Y or N and press to

continue

Warning:If parts of the patient system have

been changed and the LC selftest is notperformed, the compliance and leakageof the integrated breathing system arenot measured. The ventilator thereforeuses the data from last selftest, andtherefore the set tidal volume in VCVmode might not be correct.

Note:If the LC selftest has been bypassed,the text SELFTEST BYPASSED isshown constantly on the main display.

Warning:The patient must not be connected tothe machine during the LC selftest.

Test sequence 2 to 7 from the FULL selftest

are carried out.

4.2.3 O2 monitor test

4.2.3.1 Fuel cell sensor

If the machine is set up with an O2 monitor

using an external fuel cell sensor (see section

4.1.6), the following test must be carried out:


35/114

1. Set status to MANUAL. Y-piece must be

open to ambient air.

2. Set freshgas flow to 10 L/min AIR, and waituntil O2 % reading on main display is stable.

Check that the reading is 20-22 % O2. If not,

recalibrate the O2-monitor as described in

section 6.1.6.

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

until O2 % reading on main display is stable.

Check that the reading is 98-102 % O2. If

not, recalibrate the O2-monitor as described

in section 6.1.6.

4.2.3.2 Multigas module

If the machine is set up with an integrated

multigas module, the following test must

be carried out:

1. Set status to MANUAL. Y-piece must be

open to ambient air.

2. Set freshgas flow to 10 L/min AIR, and waituntil O2 % reading on main display is stable.

Check that the reading is 19-23 % O2.

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

until O2 % reading on main display is stable.

Check that the reading is 97-103 % O2.

4.2.4 Expired minute volume

If the machine is set up with a volume monitor

(see section 4.1.5), the following test must be

carried out:

1. Attach a test lung to the Y-piece and start

the ventilator in VCV mode. Wait approx. 1

minute and read the measured expired minute

volume on main display. Check that thiscorresponds to the set minute volume

(TVset x RRset). Check that the insp. and

exp. valves in the patient system are moving

during inspiration/expiration.

4.2.5 Airway pressure high alarm

1. Attach a test lung to the Y-piece and start the

ventilator. Read PEAK pressure on main

display and set airway pressure high alarmlimit 5 hPa below PEAK pressure.

Check that the airway pressure high alarm

starts and that the PEAK pressure is now

reduced by the new airway pressure high

alarm limit. Set the airway pressure high

alarm limit as before (above PEAK pressure)

and check that the alarm stops.

4.2.6 Mains failure alarm1. Attach a test lung to the Y-piece and start the

ventilator. Disconnect mains cable to the

machine from the mains outlet. Check that

the mains failure alarm starts, and that the

machine continues to function. Re-connect

mains cable.

4.2.7 O2 flush

1. Set status to MANUAL. Occlude the

Y-piece. Press O2 flush and check that

the respiration bag is quickly filled.


Dameca 4-13


36/114


4-14 Dameca

4.2.8 O2 alarm

1. Set freshgas flow 1 L/min O2 and 1 L/min

N2O. Disconnect O2 gas supply to the ma-chine from the gas outlet and wait until the

O2 flow column on main display goes to zero.

Check that the O2 supply pressure is low

alarm is active, and check that the N2O flow

column is also zero. Re-connect O2 gas supply.

4.2.9 Spare cylinder test

If the machine is equipped with spare cylindersfor O2 or N2O, the following test must be

performed:

1. Disconnect the central gas supply tubings

for O2 and N2O.

2. Open the valves of the spare O2 and N2O

cylinders.

3. Set the Carrier gas in the setup-menu to N2O.

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

5. Read the pressure on the spare cylinder

pressure regulator gauges on rear side

of the machine.

6. Check for sufficient cylinder pressure

(the pressure of the cylinders must never

be below 10 bar).

7. Close the spare cylinder valves.

8. Observe the pressure gauges for at least

one minute. The pressure must not

decrease.

9. Reconnect the central supply tubings to the

central gas supply.

4.2.10 Patient suction test

If the machine is equipped with a patient suction

unit, the user must check the functionality ofthis unit by the following procedure:

1. Fully open the regulator on the suction unit.

2. Remove the plastic tubing from the suction

container and block the tube opening.

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

4. Verify that the vacuum gauge indicates avacuum of at least -0.7 kPa.

5. Adjust the desired vacuum by means of the

regulator knob.

6. Close the ON/OFF switch.

7. Re-mount the plastic tubing on the suction

container.

4.2.11 Vaporizer test

The user must check the functionality of the

vaporizer(s) by the following procedure:

1. Verify that the required vaporizer(s) is

connected.

2. Check that the regulator knob on the vapori-

zer(s) turns freely in the entire regulation

area and is locked in the 0 position.

3. Verify that the vaporizer is sufficiently filled.

Note:Consult the vaporizer user manual.


37/114

4.2.12 Aux. O2

flowmeter test

If the machine is equipped with an auxiliary O2

flowmeter unit, the user must check the functio-nality of this unit by the following procedure:

1. Open the flow meter regulator (turn it

counter-clockwise).

2. Check that the flow can reach 10 ltr/min.

3. Close the regulator (turn it clockwise)

and check there is no flow.

4.2.13 Test of internal switches

1. Remove the CO2 absorber and check the

following message appears on the display

(after app. 30 sec.):

Display: Absorber disconnected

Re-mount the CO2 absorber and check the

message disappears.

2. Remove the integrated breathing system

(unlock handle) and check the following

message appears on the display:

Display: Patientsystem disconnected

Re-mount the integrated breathing system and

check the message disappears.

3. Activate the emergency freshgas switch and

check the following message appears on the

display:

Display: Emergency O2 flow activated

App. 5 L/min. added to the O2flow setting

De-activate the switch and check the message

disappears.

4. If the machine is equipped with an auxiliary

freshgas outlet, activate the switch and check

the following message appears on the display:

Display: External freshgasoutlet activated

De-activate the switch and check the messagedisappears.

4.2.14 Daily check completed

1. Set status to STBY.

2. Go to Alarm menu and select Alarm log

and then Reset.

3. Go to Alarm menu and select Set todefault.

4. Press Cancel alarms to remove old

alarm text from the display.


Dameca 4-15

Caution:When the function test has been

completed, check that the alarm settingsare suitable for the patient, beforeconnecting the patient to the machine.


38/114


4-16 Dameca

Turning the control wheel counter-clockwisewill decrease the flow.

Turning it clockwise will increase the flow.

The flow is changed immediately as the user

changes the set-flow by turning the control-

wheel.

2. Setting the O2percentage (3), or the total

flow (4), by pressing the appropriate field

on the main display.

Then the value is highlighted (blue) and

the gasflow can be changed by turning the

control-wheel.

Turning the control wheel counter-clockwise

will decrease the flow.

Turning it clockwise will increase the flow.

The flow is NOT changed, before enter is

pressed on the control-wheel.

The freshgas flow values (1), (3) and (4) on

main display are all set values.

The freshgas flow bargraphs (2) on main display

are all measured values.

If the set values and the measured values do not

match over a certain period of time, the machine

will generate an alarm.

If an oxygen flow less than 300 ml/min is set, a

message O2 flow critical low is displayed in

the alarm and message field (5 on fig. 3-3).

This message can be deleted by pressing

cancel alarms.

Flow (L/min)O2 N2O

1.00 2.00

Rotameter


3.00

O2set %

33

4

3

2

1

4.3 Operation of Electronic GasMixer

When the selftest is completed the electronicgas mixer (EGM) is ready for use.

4.3.1 Setting of freshgas flow

The freshgas flow can be set in two ways:

1. Setting the flow for each gas, by pressing the

set-flow value (1) on the main display. Then

the value is highlighted (blue) and the speci-

fic gasflow can be changed by turning the

control-wheel.


39/114


Dameca 4-17

4.3.2 Changing carrier gas

If the machine is set up with both AIR andN2O as carrier gas for O2, this carrier gas

can be changed in the setup menu.

Press the setup menu field (11 on fig. 3-3)

and the first line of the menu will say

Carrier gas. Press enter on the control wheel to activate

the Carrier gas setting. Turn the control wheel to the desired carrier

gas, and press enter on the control wheel to

confirm the new setting. The gas flow beside the O2-flow will now

change to the selected carrier gas. Besides

the carrier gas flow will change to the last

known flow setting for this specific gas. Leave the menu by pressing the normal

screen field.

Note:The O2percentage is a calculated

value based upon the measured flowdata, and not a value measured by an

oxygen analyser. In case of a hospitalpipeline cross connection, incorrectvalues will result.

The O2percentage in the patient

breathing system may differ signifi-cantly from the O2percentage of

the freshgas.

Note:If the O2, AIR or N2O driving gas

pressure is lower than 2,5 (x100 kPa)the appropriate alarm is activated.

Note:

The displayed values are basedon STPD conditions (StandardTemperature Pressure Dry).

Note:The N2O supply is cut-off in case ofan oxygen failure. When reducing theO2 flow, the N2O flow will be reduced

proportionally, securing a minimumof 25% O2 in the freshgas. N2O will

be cut of at an O2 flow less than100 ml/min.

Note:The freshgas flow can not be activatedif the machine status is STBY. Changeto MANUAL or VENT in order toopen freshgas flow.

If the total flow setting or the O2 set percentage

is changed in such a way that the O2, AIR or

N2O flow becomes less than 100 ml/min, this

flow will automatically be set to 0 L/min,and the O2 set percentage will be changed

accordingly.


40/114


4-18 Dameca

4.3.3 Electronic gas mixer default settings

When the machine is turned OFF or the FULL selftest or the LC selftest has been performed,

the settings of the electronic gas mixer will change to default values:

Parameter Factory set value Limits

Freshgas flow 0.0 L/min 0.0, 0.3-10.0 L/min

O2 set % 100% Carrier gas AIR: 21-100%

Carrier gas N2O: 25-100%

O2-flow 0.0 L/min 0.0, 0.3-10.0 L/min

AIR-flow 0.0 L/min 0.0, 0.1-10.0 L/min

N2O-flow 0.0 L/min 0.0, 0.1-10.0 L/minCarrier gas AIR AIR, N2O

4.4 Operation of stopwatch

Stop watch

00:00:00

Normal

screenGas meas. (%)

3

d

Start the stopwatch by pressing the

stopwatch field.

The colour of the HH:MM:SS will change

from grey to green and the stopwatch will

start to count.

Stop the stopwatch by pressing the

stopwatch field again, and the HH:MM:SS

will change from green to grey and the

stopwatch will stop counting.

Reset the stopwatch by pressing the

stopwatch field twice (double-click).

This can only be done when the stopwatch

is stopped.


41/114


Dameca 4-19

4.5 Operation of Ventilator

Flow (L/min)O2 N2O

1.00 2.00


17

Plateau

17

PEEP

3

Compl. 34 ml/hPa

hPa

0

20

40

Cancel

alarms

Alarm

menu

Vent. mode

VCV

Status

VENT

Resp. meas.

MVexp(l)5.8

Exp

TV(ml) 480

RR(1/min)12

8.04.0

OFF4

PSV settings

30

TV set

(ml)

500

RR set

(1/min)

12

PEEP

(hPa)

OFF

I:E

Ratio

1:2

P Insp

(hPa)

(17) More settings

When the selftest is completed the machine is

in stand-by mode, ready for automatic ventilation

after adjustment of the ventilation parameters.

The following parameters can be set when the

machine status is STBY, MANUAL orVENT.

A. Ventilation mode

During automatic ventilation the following

ventilation modes are available:

VCV (Volume Controlled Ventilation)

PCV (Pressure Controlled Ventilation)

SIMV (Synchronized Intermittent Mandatory

Ventilation) (optional)

PSV (Pressure Supported Ventilation)

In VCV mode the set tidal volume is delivered

to the patient during inspiration by a constant

inspiratory flow.

This inspiratory flow is adjusted continously

by the ventilator in order to deliver the set

tidal volume to the patient, independent of

system compliance and actual freshgas flow.

VCV is also known as CMV or IMV.

In PCV mode the set inspiratory pressure above

PEEP is applied to the patient during inspira-

tion, by a decelerating inspiratory flow.

This inspiratory flow is adjusted continuouslyby the ventilator in order to reach the set

inspiratory pressure and hold this pressure du-

ring the inspiration phase, independent of sy-

stem compliance and actual freshgas flow.

If the set inspiratory pressure is not reached

during inspiration, the ventilator generates a

PRESSURE LIMIT alarm (see section 7.3.8).

In SIMV mode the patient can trigger a VCV

inspiration during the expiration phase by

applying a decrease of the airway pressure in

the patient system. In the ventilator settings

menu the user can define at which decrease

of the airway pressure a VCV inspiration

should be triggered. The decrease of the airway

pressure is relative to the set PEEP. If the patient

has not triggered an inspiration during the

expiration phase, the ventilator automatically

gives a VCV inspiration.


42/114


4-20 Dameca

The time where the patient can trigger an inspi-

ration is called trigger-window. This trigger-

window is calculated when the mode is changed

to SIMV and is equal to the cycle time (inspira-tion + expiration) of the previous mode. When

the set resp. rate in SIMV is decreased, to force

the patient to start spontaneous breathing

during wake-up, the trigger-window is kept

at the end of the expiration phase, see picturebelow:

Triggering is never possible during

insp.time + 200msec.

Time, pressure graph in SIMV mode.

For security reasons the patient can never

trigger a new inspiration, when the ventilator

is already performing an inspiration, and just

after an inspiration has taken place.

Therefore the trigger-window is limited, so

that it can never enter the inspiration-time

plus a 200 msec. period thereafter

The patient can only trigger one inspiration in

each trigger window.

In SIMV mode the tidal volume and inspiration

time should be the same as it was in VCV mode,

even when the user prolongs the expiration

time to force the patient to start spontaneous

breathing during wake-up.

Therefore the setting of inspiration time and

volume is different in SIMV mode.

Inspiration time:

The inspiration time in SIMV mode is shown

beneath the I:E ratio setting.

If the Resp. rate, or Insp. pause is changed, the

ventilator automatically calculates a new

I:E ratio, in order to keep the inspiration

time the same.

Example:

Default settings and Resp.rate is set to 20.

This gives an inspiration time of 1 sec.

If SIMV mode is selected and the resp.rate is

then set to 10 (in order to increase expiration

time in SIMV), the I:E ratio is automatically

changed from 1:2 to 1:5, in order to keep the

inspiration time at 1 sec.

Trigger-window: triggering po ssible

Time, pressure graph in previous mode.

Time, pressure graph in SIMV mode.

Trigger-window: triggering possible


43/114


Dameca 4-21

In SIMV mode the I:E ratio can go from 1:1

to 1:9.9, since inverse I:E ratio is not allowed

in SIMV mode. Therefore Resp. rate and Insp.

pause cannot be adjusted to a setting whichgives an I:E ratio outside the 1:1 to 1:9.9

Example:

Default settings and resp.rate is set to 20.

This gives an inspiration time of 1 sec.

If SIMV mode is selected, the resp.rate can

be set from 6 resp/min (gives I:E ratio of 1:9.0)

to 30 resp/min (gives I:E ratio of 1:1).

If the user wants to change the inspiration timein SIMV mode, select I:E ratio and adjust

with the control wheel. When the I:E ratio is

adjusted, the new inspiration time is shown on

the display. However, this new setting will not

be effective until the control wheel is pressed.

Set volume:

If the ventilator is installed with Minute

volume as set volume, the tidal volume in

SIMV mode is shown beneath the MV setsetting.

If the Resp. rate is changed, the ventilator

automatically calculates a new minute volume

setting in order to keep the tidal volume the

same.

Example:

Default settings and Resp. rate is set to 20.

This gives a tidal volume of 300 ml.

If SIMV mode is selected, and the resp.rate

is then set to 10 (in order to increase expiration

time in SIMV), the set minute volume is

automatically changed from 6.0 to 3.0, in

order to keep the tidal volume at 300 ml.

If the user wants to change the tidal volume in

SIMV mode, select MV set and adjust with

the control wheel. When the set minute volume

is adjusted, the new tidal volume is shown onthe display. However this new setting will not

be effective until the control wheel is pressed.

Note:In the service-menu it can be definedwhether SIMV mode shall be availableor not. This definition can be changed

by a super-user or a technician.

In PSV mode it is only the patient who controls

the ventilator, as the ventilator does not give any

mandatory inspirations to the patient. Therefore

this mode is for patient with a certain degree of

spontaneous respiration, where the ventilator

assists the respiration of the patient.

Inspiration:

When the patient starts an inspiration, and the

inspiratory flow at the Y-piece (measured by the

flow sensor) is higher than the set Insp. trig.,

the ventilator starts an inspiration, to reach the

set Support pressure.

When this support pressure is reached, the

ventilator maintains the pressure in the rest of

the inspiration phase.

Expiration:

The inspiration stops and the expiration starts if

one of the following conditions are met:

1. The pressure reaches the high alarm

(same as for the other ventilation modes).


44/114


4-22 Dameca

2. The inspiration time is more than 2.5 sec.

(if flow sensor is Adult) or 1.5 sec.

(if flow sensor is Paed.)

3. The patient inspiratory flow at the Y-piece

(measured by the flow sensor) is lower than

the set Exp. trig.

The Exp. trig. is set as a % of the measured

peak flow during inspiration.

Ventilation backup:

If the patient does not trigger an inspiration

before the PSV backup period has ended, a

PSV BACKUP MODE ACTIVATED,SWITCHING TO PCV alarm starts (see section

7.3.14) and the ventilator automatically switches

to PCV mode.

The alarm disappears when the cancel alarms

button is pressed.

B. Tidal volume/Minute volume (active in

VCV or SIMV mode only)

The tidal volume/minute volume delivered

by the ventilator in VCV or SIMV mode isautomatically compensated for the compliance

of the breathing system and for the f

Siesta i TS 10650E-90 UK Apr08

Documents

Transcript of Siesta i TS 10650E-90 UK Apr08