Siare Sirio S2 / T User manual

DU5051114

( rev.4) 01.06.2005

LUNG VENTILATOR

Sirio S2 / T

SERVICE MANUAL

Sirio S2 / T Service Manual

DU5051114 3 ( 30 ) ( rev.4) 01.06.2005

INDEX

1INTRODUCTION ............................................................................................................................. 5

1.1 Main characteristics of SIRIO S2/T .......................................................................................... 5

1.2 Operating.................................................................................................................................. 6

1.3 Norms....................................................................................................................................... 6

1.4 Warnings .................................................................................................................................. 7

2DESCRIPTION OF SIRIO S2/T LUNG VENTILATOR ................................................................... 9

2.1 Front view................................................................................................................................. 9

2.2 Left and right side views......................................................................................................... 10

2.3 Bottom side view .................................................................................................................... 10

3PREPARATION TO USE ..............................................................................................................11

3.1 Electric connection ................................................................................................................. 11

3.1.1 External battery supply............................................................................................................... 11

3.1.2 Safety fuses ............................................................................................................................... 11

3.1.3 Connection to other equipments ................................................................................................ 11

3.2 Medical gas connection..........................................................................................................11

3.3 Silicone patient circuit connection .......................................................................................... 12

4HOW TO USE THE SIRIO S2/T LUNG VENTILATOR................................................................. 13

4.1 General................................................................................................................................... 13

4.2 Operating MODES .................................................................................................................13

4.2.1 OFF............................................................................................................................................ 13

4.2.2 AUT + AST................................................................................................................................. 13

4.2.3 PSV............................................................................................................................................ 13

4.2.4 CPAP ......................................................................................................................................... 13

4.3 Optional operations ................................................................................................................ 14

4.3.1 Vehicular power supply.............................................................................................................. 14

4.3.2 Internal battery ........................................................................................................................... 14

4.3.3 PEEP ......................................................................................................................................... 14

4.3.4 Variable TRIGGER .................................................................................................................... 14

5MAINTENANCE ............................................................................................................................ 15

5.1 General................................................................................................................................... 15

5.2 Scheduled Maintenance (performed by the operator) ........................................................... 15

5.2.1 Cleaning of the housing ............................................................................................................. 15

5.2.2 Washing ..................................................................................................................................... 16

5.2.3 Disinfecting by cold immersion................................................................................................... 16

5.3 Spare parts............................................................................................................................. 16

5.4 Special waste materials .........................................................................................................16

6SERVICE ....................................................................................................................................... 17

6.1 Electric and pneumatic calibration ......................................................................................... 17

6.1.1 Electric calibration...................................................................................................................... 17

6.1.2 Pneumatic calibration................................................................................................................. 18

6.2 Testing.................................................................................................................................... 18

7DRAWINGS ................................................................................................................................... 23

7.1 Electric connections ............................................................................................................... 23

7.2 Pneumatic drawing................................................................................................................. 24

7.3 Electronic boards.................................................................................................................... 25

7.3.1 Main board ................................................................................................................................. 25

7.3.2 Power board............................................................................................................................... 26

7.3.3 Analogic board ........................................................................................................................... 27

7.3.4 Logic board ................................................................................................................................ 28

8TECHNICAL DATA SHEET .......................................................................................................... 29

8.1 Legend of abbreviations and symbols.................................................................................... 30

Service Manual Sirio S2 / T

( rev.4) 01.06.2005 4 ( 30 ) DU5051114

Warning !!

“SIARE” is used throughout this manual as an abbreviation for:

SIARE HOSPITAL SUPPLIES S.r.l.

Via Giulio Pastore, 18 - 40056 Crespellano (BO) - ITALY

Tel.: 051.969802 / Fax: 051.969101

In quality of Manufacturer of the equipment described in the present manual.

Sirio S2 / T Service Manual

DU5051114 5 ( 30 ) ( rev.4) 01.06.2005

1 INTRODUCTION

This manual is expressly intended for SIARE qualified personnel or for qualified technical personnel,

officially authorized by SIARE to maintain the SIRIO S2/T.

The present manual describes the SIRIO S2/T and its operation principles, by the aid of constructive,

electrical and pneumatic drawings.

The SIARE qualified personnel or the qualified technical personnel officially authorized by SIARE, must

know the complete content of the present manual, before performing the operations described here

below.

The technician authorized by SIARE is equipped with proper tools and spares and he is instructed to

operate for products preservation.

SIARE declines all responsibilities arising from technical intervention performed on the

equipment without a formal authorization by SIARE.

A proper and safe use of SIRIO S2/T lung ventilator both for the patient and the operator requires the

perfect knowledge of the recommendations and instructions indicated in the present manual.

1.1 Main characteristics of SIRIO S2/T

The portable SIRIO S2/T lung ventilator is specially designed to be used in emergency, first-aid, intra-

hospital transportation and it is destined to be applied on adults, children and newborns.

The following ventilation modes are featured:

• at continuous flow (CPAP);

• automatic ventilation through a time cycled breathing activity synchronized with the patient’s

spontaneous activity (AUT+ AST);

• assisted with pressure support (PSV - Pressure Support Ventilation).

Among the default functions the following can be adjusted:

• breathing cycle frequency in AUT+AST mode (Fix I:E Ratio 1:1,5);

• delivered minute volume or flow;

• max airway pressure limit in AUT+AST mode;

• pressure support level in PSV;

• oxygen concentration (MIXER 50 or 100%).

SIRIO S2/T measures and displays:

• the instant airways pressure;

• the spontaneous patient activity in AUT+ AST and PSV modes;

• an eventual alarm status (LOW PAW/APNEA, GAS SUPPLY, LOW BATT, HIGH PAW/LIMIT,

POWER FAILURE).

The ventilation of critical patients without continuous control must be effected by using an

external spirometer having alarms on minute volume.

Service Manual Sirio S2 / T

( rev.4) 01.06.2005 6 ( 30 ) DU5051114

1.2 Operating

For a correct and complete operating the equipment must be connected to the medical gas distribution

system outlet or to the cylinder outlet.

In order to supply mixtures at 21% O2the equipment can be connected to medical compressed air. In

this case the adjustment of the mixer at 50% and 100% values will not affect the concentration.

SIRIO S2/T has a built-in battery that allows it to operate for at least 6 hours when the battery is fully

charged and in good operating order.

An external 12 Vdc battery (from an ambulance, helicopter, etc...) can also be used as a source of

power for SIRIO S2/T .

SIRIO S2/T includes an airway pressure gauge for measuring the patient’s airway pressure, a patient’s

spontaneous activity sensor and a sensor that activates an alarm for low airway pressure.

It is necessary to check these sensors before using them, in order to avoid incorrect evaluation of the

patient’s ventilation. The test procedures are described in chapter 4 of this manual.

The electrical and medical gas system connections should be made as per the procedures described in

chapter 4.

1.3 Norms

SIRIO S2/T is a lung ventilator manufactured according to the following norms:

CEI 62-5 : 1991 (EN 60601-1) Electromedical Equipment.

Part 1: General Safety Norms

UNI EN 794-3 Particular requirements for emergency and transport ventilators

CEI 62-50 :1993 (EN 60601-1-2) Electromedical Equipment.

Part 1: General Safety Norms.

Part 2: Collateral Norms: Electromagnetic Compatibility –

Recommendations and tests.

CEI 64-4 Electrical Installation in locations used for medical practice.

IEC 601-4 Programmable devices

ISO 5356 (EN 1281) Connectors

Dir. 93/42/CEE

Dir. 89/336/CEE

Medical devices

Electromagnetic compatibility

Sirio S2 / T Service Manual

DU5051114 7 ( 30 ) ( rev.4) 01.06.2005

1.4 Warnings

This symbol means that an important note or information is following.

This symbol means that a very important remark for the patient’s and operator ‘s

safety is following.

In order to grant maximum reliability and to ensure the patient and operator’s safety, SIRIO S2/T was

designed and manufactured following warranty standards of quality of the product and its components.

Therefore safety of SIRIO S2/T is warranted only if it is used following the procedures described in the

user’s manual.

For safety reasons, it is necessary to perform the scheduled maintenance described in this manual.

Maintenance and replacement of spare parts should be made by personnel authorized by SIARE only

and original SIARE spare parts or spare parts checked by SIARE should be used without exceptions.

SIARE is not held liable (Civil Law or Penal Code) in the following situations.

1) If SIRIO S2/T is used not for the aims or in the conditions described in the present manual.

2) For lack or omission of performance of the scheduled maintenance as described in this manual.

3) For maintenance not performed by SIARE authorized.

4) If non-original spare parts or parts not checked by SIARE were used.

5) If connected to devices not in conformity with governmental safety norms for the recommended

use.

Do not use this equipment near flammable gases.

Make an inspection prior to use.

Do not connect the equipment to the patient by using conductive antistatic tubes.

Regarding the general safety of the electro-medical equipment, it is important to follow all rules

regarding the interaction between the equipment and the patient, the operator and the nearby

environment.

In order to ensure proper and safe use of the equipment, it is crucial to follow the instructions and pay

attention to the notes furnished in this user’s manual.

In order to use this equipment, it is vital to know all the instructions present in this manual.

Service Manual Sirio S2 / T

( rev.4) 01.06.2005 8 ( 30 ) DU5051114

The equipment must be checked and inspections must be performed by SIARE authorized personnel

every 800 operating hours, or in case of limited use of the unit, at least every 6 months.All

maintenance performed by SIARE authorized personnel is recorded in the equipment’s maintenance

file.

Every repair must be performed by SIARE authorized personnel.

SIARE is not liable for direct or indirect damage to people or things, due to technical assistance by

SIARE non-authorized personnel or improper use of the equipment, that is to say a use not described in

the user’s or technical manuals.

In order to repair the equipment malfunctioning, defects or broken parts, the operator should contact

SIARE or its authorized local service dealer.

It is important, when requesting service, to specify the model and serial number of the equipment.

It is recommended to have a maintenance and assistance contract with a SIARE authorized service

dealer, in order to guarantee the scheduled maintenance required to operate the equipment in a safe

and correct manner.

Use the recommended accessories only.

The use of other accessories is authorized only by a written authorization from SIARE as per the safety

directives in effect.

Operation of the equipment is authorized only in areas which are in conformity with the safety directives

in effect.

This unit is not approved for use in areas with danger of explosion.

This unit cannot be used in the presence of explosive gases.

Before connecting the unit with other electrical equipment not described in this

manual, check with the manufacturer.

Sirio S2 / T Service Manual

DU5051114 9 ( 30 ) ( rev.4) 01.06.2005

2 DESCRIPTION OF SIRIO S2/T LUNG VENTILATOR

2.1 Front view

The SIRIO S2/T lung ventilator is composed of the following parts.

5 4

1 PAW AIRWAYS PRESSURE: mechanic airway pressure gauge which displays the instantaneous airway

pressure.

2 ALARM RESET: for safety reasons the acoustic alarm silencer operates for 20 seconds, the

alarm is enabled again whenever the airway pressure exceeds 8 cmH2O.

This key also allows to silence the POWER FAILURE ALARM. In critical patients, especially

when the operator is not present, it is good practice to connect a breathing monitor in order to

verify the ventilation from a volumetric point of view also, not just from a pressure point of view.

3 MINUTE VOLUME: it is a control knob permitting to set the liters per minutes to be delivered to the patient. The

suggested settings for adult and pediatric patients are marked on the scale.

4 MODES: knob for selection of the following operating modes: OFF, AUT+AST, PSV, CPAP.

5 RATE: this scale is used in the AUT+AST mode.

6 PRESSURE LIMIT: it is a knob that regulates the maximum airway pressure limit.

7 MIXER: option to select between 50% O2and 50% AIR or 100% O2.(operating only in case of connection to O2)

8 PEEP: knob to set the end tidal positive pressure.

9 Handle for transport and fixing on 30x10 mm bar.

Service Manual Sirio S2 / T

( rev.4) 01.06.2005 10 ( 30 ) DU5051114

2.2 Left and right side views

10 14

12 15

10 EXP. VALVE: for the expiratory line of the patient circuit to be connected.

11 INSP. VALVE: for the inspiratory line of the patient circuit to be connected.

12 AIR FILTER: it is a one way direction valve that allows the patient in spontaneous ventilation to inspirate

ambient air in case the ventilator ceases working or insufficient volume is performed.

13 GAS SUPPLY: pneumatic supply inlet where to connect oxygen or medical compressed air at 2.8÷6 bar.

14 POWER SUPPLY: 12Vdc plug, for an external 12Vdc battery to be connected; for example the one on

ambulance (vehicular power supply).

15 BATTERY: if removed, the vehicle supply fuses box and the internal battery supply one are visible.

16 Identification label where model, power supply, number and value of fuses, power absorbed and

serial identification number are indicated.

2.3 Bottom side view

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