Sirio S2 / T - Frank`s Hospital Workshop
Contents
1. 13 RTT 13 4 2 Operating 5 13 LA MESI EE 13 42 22 AUT RAST L 13 24 2 9 PSM Sus Ae 13 4 2 4 A A 13 4 3 Optional Operations ilaele aliena loan 14 4 3 1 Vehicular power 14 A 14 4 9 9 PEEP gt x uuu 14 4 3 4 Variable TRIGGER istaec I dadas de dada 14 5 MAINTENANCE ai 15 5 General ns 15 5 2 Scheduled Maintenance performed by the operator 15 5 2 1 Cleaning of the NOUSING re ted hne gene etc pa tpe n s Re SUCH Fo FREE ELA E Ed Le epu ERU po ERO ine 15 5 2 2 WASNING E 16 5 2 3 Disinfecting by Cold 16 5 3 OMA tt A 16 5 4 Special waste materials 2 16 SERVICE 17 6 1 Electric and pneumatic calibration 17 6 1 1 Electric calibration n e L RA SS 17 6 1 2 Pneumatic 18 622. erue ere iii 18 T 5 25555046 nri euo ab n re Saa XY REF 23 7 1 Electric connections 23 7 2 Pneumatic drawing i 24 7 3 Electronic 25 73321 SMAIN etes 25 1 3 2 POWOPDOAIO iri Ice rust eret irruere ad 26 7 3 3 Analogic board i 27 TIA ODIO lop 28 8 TECHNICAL DATA SHEET coin rar 29 8 1 Legend of abbreviations and symbols 11100 nano nc eene 30 DU5051114 3 30 rev 4 01 06 2005 e Service Manual f Sirio S2 T 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 rev 4 01 06 2005 4 30 DU5051114 Sirio e 52 f Service Manual 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 m
3. MINUTE VOLUME 19 AA litres gt RESET le 6 ONLINE 510 16 GH PAY LIMIT N 4H FO a Low PAW APNOEA 50 4 GAS SUPPLY e 4 POWER FAILURE LUNG VENTILATOR Sirio S2 T SERVICE MANUAL DU5051114 rev 4 01 06 2005 Sirio 52 Service Manual INDEX 1 INTRODUCTION k u I aei icc Suede e re cc He E c RE 5 1 1 Main characteristics of SIRIO 52 7 5 EZ Opera l 6 13 ina 6 M 7 2 DESCRIPTION OF SIRIO S2 T LUNG VENTILATOR 9 2 1 TAS MMMEER 9 2 2 Left and right side vieWS 10 2 3 Bottom Side VIEW decere x a uM OR 10 3 PREPARATION TO USE 0 d arr EY Ex Ee FE e 11 3 1 Electric COMEN iii ea e e PR tie 11 3 14 1 External battery supply iine eL Ere aeneus toe ees Hone Rea SE pa ROC Feo eerie e ERE cp 11 31 2 Safety TUSES net 11 3 1 3 Connection to other sns 11 3 2 Medical gas 11 3 3 Silicone patient circuit 12 4 HOW TO USE THE SIRIO S2 T LUNG VENTILATOR
4. N amp amp OR ON ON x c E MT LLL N oppii p cea s pm DU5051114 25 30 rev 4 01 06 2005 Service Manual Sirio S2 T 7 3 2 Power board rev 4 01 06 2005 26 30 DU5051114 Sirio S2 T Service Manual 7 3 3 Analogic board DU5051114 27 30 rev 4 01 06 2005 Service Manual 7 3 4 Logic board E gs LOW el lt use ranoos 55111123 Sirio S2 T rev 4 01 06 2005 28 30 DU5051114 Sirio S2 T Service Manual 8 TECHNICAL DATA SHEET Application Patients Ventilation type Control modality Flow generation Gas feeding Ventilation modes Measured parameters Breathing frequency Ratio Inspiratory time Inspiratory pause Pressure limit Pressure support ventilation PEEP Tidal volume Minute volume Mixer device Bronchomanometer Trigger sensitivity Alarms Medical Gas Electric power supply Current consumption Power Battery operation Safety devices User s interface External connections Emergency First Aid Transport Adults Children Newborn babies IPPV volumetric IPPV time cycled and with PRESSURE SUPPORT Electronic Venturi system Oxygen or compressed medical Air at 2 8 6 bar CPAP AUT AST PSV APNEA BACK UP PEEP Airways pressure From 5 to 70 bpm 1 1 5 4096 of breathing cycle Automatic setting durin
5. e spontaneous patient activity in AUT AST and PSV modes e eventual alarm status LOW PAW APNEA GAS SUPPLY LOW 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 05051114 5 30 rev 4 01 06 2005 Service Manual f Sirio S2 T 1 2 1 3 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 O gt the 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 connection
6. tightened in particular in case of use with other machines and in general if there are situations which could compromise the correct safe operation of the SIRIO S2 T in order to preserve ventilator integrity Verify the label presence Check that the identification label with data relevant to predisposed power supply for the equipment is present rev 4 01 06 2005 18 30 DU5051114 Sirio S2 T Service Manual 3 Verify the operative mode AUT AST Select the AUT AST operative mode with the operative modes selector Set the following parameters Rate 20 BPM High Press limit 50 cmH20 Minute volume 9 LPM Check that the Airways pressure manometer indicates a value between 15 cm H20 and 25 cm 20 At the end of expiratory phase generate a depression in the patient circuit by pull out the patient simulator bellows Verify that the inspiration leds become red and that the inspiration act is generated 4 Verify the operative mode PSV Select the PSV operative mode by pressing the corresponding button on the front pane Set the following parameters Rate 15 BPM High Press limit 20 cmH20 Minute volume 9 LPM Generate a depression in patient circuit by pulling out the patient simulator bellow Verify that the inspiration leds become red and an inspiratory act is generated so to reach the pressure level of 20 2 cmH20 5 Verify the operative mode PEEP Select the AUT AST operative mode wi
7. 00 O operating only in case of connection to 02 PEEP knob to set the end tidal positive pressure ON OO Handle for transport and fixing on 30x10 mm bar DU5051114 9 30 rev 4 01 06 2005 Service Manual Sirio S2 T 2 2 Left and right side views 10 14 11 12 15 13 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 one way direction valve that allows the patient 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 16 VOUT 12VOC 1518VA6 5080 He WATT 13 FUSE 2X1AT ADS 1 B 9942 CAES C N O 33 4 01 06 2005 10 30 DU5051114 Sirio S2
8. T f Service Manual PREPARATION TO USE Electric connection The electrical connection of the unit is a very important phase because incorrect connections or connection to electrical installations not in conformity to the specifications can be risky for the patient and operator s safety The electrical installation should conform to the local norms for medical installations type A CEI 64 4 Check that the data on the identification label power supply frequency and consumption are compatible with the electrical installation External battery supply Connect the 12Vdc external battery to the plug 14 by using our cable N WARNING Check polarity 3 1 2 3 2 The red cable should be connected to the positive pole of the battery Turn the MODES selector on the front panel and check that the unit is switched on Safety fuses Replace the safety fuse according to the parameters on the label Fuses with incorrect values can compromise the operation and safety of the unit Connection to other equipments If the equipment to be connected is a SIARE unit all the instructions necessary for the connection can be found in the documentation enclosed If the equipment to be connected is not a SIARE unit please contact the manufacturer or a qualified technician for assistance This unit conforms to norms IEC 60601 1 2 for electro magnetic compatibility It is a good rule to install it together with other devices which
9. ange inlet of flow analyzer unit Set the following Minute Volume values and for each of them its corresponding value of RATE as per table Verify that the displayed Tidal Volume values on flow analyzer unit are within the corresponding acceptance limits see table MINUTE VOLUME RATE SETTING ACCEPTANCE MAX ACCEPTANCE SETTING Liters MIN LIMIT Liters LIMITS Liters rev 4 01 06 2005 22 30 DU5051114 e Sirio S2 T f Service Manual 7 DRAWINGS 7 1 Electric connections SWITCH Yellow green cable to connect to earth DEVICE EMERGENCY HOUSING BATTERY 3 CONNECTOR FOR EXTERNAL POWER SUPPLY CONNECTOR FOR FLAT CABLE INLET PRESSURE SENSOR MAIN BOARD 05051114 23 30 rev 4 01 06 2005 Service Manual Sirio S2 T 7 2 Pneumatic drawing AIRWAY PRESSURE PRESS TRANSDUCER LPV2 EXP VALVE AIR SAFETY PEEP VALVE FILTER SCARICC VALVOLA UNIDIREZ INSP EXP VALVOLA UNIDIREZ VENTURI PUMP BLENDER 50 100 OXYGEN FR 1 MINUTE VOLUME FLOW 45 L MIN FR 5 REGOLAZIONE MIXER FLOW 45 L MIN FR 6 DISCHARGE FR2 LIMIT PRESSURE S PV 1 EV 1 INSP INSP 4 bar OUT INLET O2 AIR 2 836 bar rev 4 01 06 2005 24 30 DU5051114 Service Manual Sirio S2 T 7 3 Electronic boards 7 3 1 Main board Sian o me i HOQ 20 06000 0000 E n
10. are also in conformity to the same norms for a good operation Medical gas connection This unit can be connected to the hospital main gas O or AIR supply or to an oxygen cylinder N WARNING The assembly of the compatible connectors with the hospital main gas supply as all maintenance operations and or the replacement of all medical gas supply tubes should be exclusively performed by highly qualified technicians in order to avoid gas inversions that can kill the patient Insert the connector of the oxygen tube 21 included to the main gas connector 13 in order to use the main system the technician has to perform the connection of the inlet 23 not included compatible with the hospital main medical gas supply to the tube If an oxygen cylinder is used connect the oxygen connector 20 to the main supply 13 then insert the tube 22 into the pressure reducer of the cylinder and open the valve The medical gas pressure should be 2 8 6 bar DU5051114 11 30 rev 4 01 06 2005 Service Manual Sirio S2 T 4 The compressed air should be classified for medical use and therefore it should not contain oil and it should be filtered For installation to other units always check the proper manuals 3 3 Silicone patient circuit connection gt 10 Expiratory valve control tube connection gt 11 Inspiratory patient circuit connection gt 24 D 15 corrugate
11. d tube patient circuit inspiratory line gt 25 Airways pressure reading tube gt 26 Expiratory valve rev 4 01 06 2005 12 30 DU5051114 Sirio S2 T f Service Manual 4 2 1 4 2 2 4 2 3 4 2 4 HOW TO USE THE SIRIO S2 T LUNG VENTILATOR General The outcome of the preliminary functional test must be positive in order to ensure the proper functioning of SIRIO S2 T After the inspection phase SIRIO S2 T can be connected to the patient by using the patient circuit 4 2 ATTENTION To follow the instructions and the warnings reported in the User s Manual enclosed with the SIRIO PLUS machine Operating MODES OFF When the 4 selector knob is on OFF the unit is off AUT AST When the MODES 4 selector is on AUT AST the ventilator operates as a synchronized with assisted breaths time cycled ventilator When there are no spontaneous breaths the ventilator effects an automatic time cycled ventilation If the pressure limit knob is set to values higher than the ventilation pressure the ventilator operates as a volumetric ventilator and the Minute Volume can be set with the relative regulator 3 If the pressure limit knob is set to values lower than the ventilation pressure the ventilator operates as a time cycled pressure metric ventilator and the flow be set with the relative regulator 3 PSV When the MODES 4 selector is PSV the ventilator operates a
12. f 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 IfSIRIO S2 T is used not for the aims or in the conditions described in the present manual 2 Forlack 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 f connected to devices not in conformity with governmental safety norms for the recommended use N 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 DU5051114 7 30 rev 4 01 06 2005 Service Manual f Sirio S2 T The equipment must be checked and inspections must be performed by SIARE auth
13. g PSV mode Adjustable from 0 to 50 cmH20 Adjustable from 0 SPONT to 50 cmH O Adjustable from 0 to 20 cmH20 From 15 to 3000 ml From 1 to 16 l min 50 or 100 O gt 21 O gt with medical compressed air supply Mechanical from 20 to 80 cmH O Adjustable from 1 to 6 cmH20 Low and high airways pressure Apnea Low battery Gas supply Power failure Oxygen or Compressed Medical Air at 2 8 6 bar 220 Vac 12 Vdc 110 Vac optional 0 02 A 220 Vac 0 4 A 12 Vdc 4 5 W With internal Pb battery approx 6 hours operation Mechanical limit of airways pressure adjustable from 0 to 50 cmH O Mechanical bronchomanometer Control knobs Alarm Led LED messages e to display the correct ventilation proceeding e to display the battery charge level Electrical power supply 12Vdc or power supply 220Vac or 110Vac 12Vdc Gas air or oxygen DU5051114 29 30 rev 4 01 06 2005 Service Manual Sirio 52 Dimensions 23x 13x 15 cm Wx D xH Weight 3 5 Kg Standard accessories Power supply cable 12 Vdc code 530147100 supplied Silicone patient circuit with expiratory valve code 102631 SLU Disposable patient circuit in PVC with expiratory valve code A36 049001 Feeder 220 Vac 12Vdc code G30146100 O2 tube code G60005100 User s manual Conformity to Norms Internationals Natio
14. intained as per the instructions in this manual and the technical manual The Technical Assistance Report signed by the authorized SIARE technician is proof of the completion of the scheduled maintenance Scheduled Maintenance performed by the operator Cleaning of the housing The case of the unit does not require special provisions for its cleaning It can be done whenever necessary by using a disposable cloth moistened with regular detergent Disinfectants i e Buraton 10F diluted as per manufacturer s instruction with regular detergent can also be used as needed Ensure that no liquid enters into the internal parts of the unit The following detergents should not be used as they can damage the unit halogenated compounds strong organic acids oxygenated compounds 05051114 15 30 rev 4 01 06 2005 Service Manual f Sirio 52 5 2 2 5 2 3 5 3 5 4 Washing Wash the disassembled components with a pH of 4 to 8 5 detergent Rinse with running water Disinfecting by cold immersion Place the disassembled components in a solution of disinfectant following its instructions Rinse with water preferably decalcified and shake well in order to remove any residual water Let it dry well Spare parts Use only original SIARE spare parts or spare parts checked by SIARE In absence of indications the parts can be replaced upon Physician or Technician s opinion in case of failure or wo
15. is equipped with proper tools and spares and he is instructed to operate for products preservation For electric and pneumatic connections drawing refer to chapter 7 Electric and pneumatic calibration Tools devices and consumables Multimeter Manometer 20 100 cmH O Oscilloscope Flow analyzer tester for analog lung ventilator Perform the following connections Make the electric and pneumatic connections relevant to the ventilator to be calibrated Power the circuit and select the AUT mode Electric calibration Necessary tools devices Frequency meter Voltmeter Compressor Proceed as described here below see layout on page 25 a Connect the frequency meter between GND and the 4 pin of U5 b Rotate the potentiometer present on the panel at the maximum rate Regulate the trimmer R2 to read a frequency of around 7850Hz 50Hz d Rotate the potentiometer present on the panel to the minimum rate e Regulate the trimmer R3 to read the frequency of around 620Hz 10Hz f Connect the voltmeter between GND and the 2 pin of U4 DU5051114 17 30 rev 4 01 06 2005 Service Manual f Ic Sirio S2 T Rotate the trimmer R30 to read 1 Volt on device Apply 20 cmH5 O to pressure transducer Rotate the trimmer R40 to read 2 4 Volts on device Take off pressure from transducer and repeat the points g h i j until it is no more necessary to intervene on trimmers Apply 30 cmH5O
16. lator and patient simulator manometer display remains displayed a pressure of 20 cmH20 2 cmH5O for all setted time 10 seconds 12 Verify the low pressure apnoea alarm Switch on the ventilator in AUT AST mode Regulate the Minute Volume so that the displayed pressure on the manometer of the patient simulator and ventilator is over 10 cmH O Reduce the Minute Volume so that the pressure decrease to 9 cmH O Verify that within 30 secs the alarm sounds and that the APNOEA led lights on on front panel Disconnect the patient circuit from the simulator Verify that within 30 secs the alarm sounds and APNEA led lights on DU5051114 21 30 rev 4 01 06 2005 Service Manual f Sirio 52 13 Verify the high pressure alarm Set the following parameters Operative mode AUT AST Minute Volume 9 LPM Rate 10 bpm Set high pressure alarm at maximum Obstruct the Y connector of patient circuit and verify that an high pressure acoustic alarm sounds and that the max displayed pressure ventilator manometer do not reach 50 max mechanic limit 14 Verify the gas supply alarm Set the following parameters Operative mode IPPV or AUT AST Connect the patient circuit to the simulator Close the pneumatic supply Verify that an alarm sounds and that the corresponding led lights on 15 Verify the functionality Select the AUT AST operative mode Connect the patient circuit to High flow r
17. n assisted ventilation with pressure support In this mode the machine only helps in the breathing work The value of supplied pressure increases according to the set HIGH PRESSURE LIMIT When the HIGH PRESSURE LIMIT is set to ZERO the unit performs only the flow that the patient can generate spontaneously therefore without pressure support When the patient stops breathing after approx 20 seconds the ventilator automatically switches in AUT AST APNEA BACK UP mode CPAP With MODES 4 selector on CPAP the ventilator delivers a continuous flow into the patient circuit In this way the patient is free to breathe spontaneously into the circuit During spontaneous breathing the pressure must oscillate around the set value and must decrease when the patient inspires and increase when he expires If this oscillation is too extended more than 30 it is necessary to set an higher flow so that the oscillation decreases DU5051114 13 30 rev 4 01 06 2005 Service Manual f Sirio 52 4 3 4 3 1 4 3 2 4 3 3 4 3 4 Optional operations Vehicular power supply SIRIO S2 T can operate with an external 12 Vdc battery such as the vehicular battery when connected to a 12Vdc plug located on the side 14 Internal battery SIRIO S2 T is equipped with an internal battery that when fully charged and in proper working condition guarantees at least 6 hours of autonomy Its charge level is always checked therefo
18. nals International Generals IEC 601 1 CEI 62 5 Lung Ventilators for Emergency UNI EN 794 3 and Transport Medical devices D 93 42 CEE Electromagnetic Compatibility IEC 601 1 2 T Dir 89 336 EMC 1993 CEI 62 50 Electric equipment in medical CEI 64 4 environments Programmable devices IEC 601 1 4 Anaesthesia and resuscitation machine Tapered EN1281 1 ISO 5356 connections Dir 93 42 Class and type Class llb CEI Class and type Class S E I Type B Environmental conditions Temperature from 10 to 40 C Relative humidity from 10 to 9096 non condensing Atmospheric pressure from 70 to 110 kPa 8 1 Legend of abbreviations and symbols Abbreviation Description PAW Airway pressure APNEA ALARM Apnea alarm RATE Set breathing rate MINUTE VOLUME Minute volume LOW PAW ALARM Low airway pressure alarm GAS SUPPLY ALARM Lack of gas supply alarm from pneumatic installation LOW BATT ALARM Low battery level alarm BATT LEVEL Battery level rev 4 01 06 2005 30 30 DU5051114
19. orized 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 N This unit cannot be used in the presence of explosive gases Before connecting the unit with other electrical equipment not desc
20. quire a perfect knowledge of the equipment and therefore must be performed by highly qualified and specifically trained personnel only who has been formally authorized by SIARE The anesthetist or doctor is responsible for the ordinary maintenance of the unit as described in this chapter Instructions about how and how often it is suggested cleaning disinfecting sterilizing and replacing parts are indicated in this manual and should be strictly followed in order to avoid damage to the equipment and also endanger the patient and operator s safety The components have been selected after technical and comparative tests in the designing phase of the machine Furthermore the same components have been tested during the manufacturing cycle in order to obtain the maximum level of safety and reliability for the operator and patient For the above mentioned reasons whenever a part needs to be replaced it must be an original spare part which has been checked and tested by SIARE The scheduled inspections and maintenance are performed automatically if a maintenance contract is signed with SIARE or with an authorized dealer For more information please contact SIARE to have the coordinates of an authorized service dealer in your area When you require service please indicate the serial number of the unit and the problem to SIARE or to your authorized technicians SIARE assumes responsibility for all provisions of the law if the unit is used and ma
21. re when there is about 5 minutes of operating time left LOW alarm is enabled SIRIO S2 T incorporates also a system for recharging the battery through the main power supply 15 PEEP Turn the PEEP knob 8 in order to set the end tidal positive pressure which can vary from 0 to 20 cmHb o0 the relative value is displayed on the bronchomanometer 1 1 Variable TRIGGER The trigger level which detects the spontaneous activity of the patient is set by default at 1 cmH gt 0 The operator can vary the level from 1 to 6 cmH20 anyway by acting as follows switch the ventilator on using the MODES knob 4 and at the same time keep the ALARM RESET key pressed 2 as long as led 1 on the alarm section is on then push again the ALARM RESET key 2 in order to change the level of sensitivity from 1 to 6 cmH50 once the value is set wait for 3 seconds and the level of sensitivity will be maintained till the unit is switched off When the ventilator SIRIO S2 T is switched on again the set value will be the default one i e 1 20 rev 4 01 06 2005 14 30 DU5051114 Sirio S2 T f Service Manual 5 5 1 MAINTENANCE General N WARNING To ensure the patient and operator s safety SIRIO S2 T has to be checked and 5 2 5 2 1 inspected every 800 operating hours or in case of limited use of the unit at least every 6 months These inspections and tests re
22. ribed in this manual check with the manufacturer rev 4 01 06 2005 8 30 DU5051114 Sirio S2 T f lt 4 Service Manual 2 DESCRIPTION OF SIRIO S2 T LUNG VENTILATOR 2 4 Front view The SIRIO S2 T lung ventilator is composed of the following parts 9 3 2 1 7 8 PAW AIRWAYS PRESSURE 1cmH 02 1 hPa 5 4 6 BPM PRESSURE LIMIT CPAP emHO 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 UN alarm is enabled again whenever the airway pressure exceeds 8 cmH20 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 MODES knob for selection of the following operating modes OFF AUT AST PSV CPAP RATE this scale is used in the AUT AST mode PRESSURE LIMIT it is a knob that regulates the maximum airway pressure limit MIXER option to select between 50 O gt and 50 AIR or 1
23. rm parts The scheduled replacement for ordinary maintenance concerns the patient circuit see codes on the technical data sheet 8 Standard Accessories table replacement every 6 months is highly suggested The replacement of 12Vdc battery 1 3Ah code E96512000 is to be effected every 24 months Special waste materials Batteries accumulators and O cells do not put them in the fire explosion risk do not open them corrosion danger do not recharge batteries The batteries and the accumulators are special waste materials and they must be put in appropriate containers in conformity to local norms for getting rid of such waste materials For further information contact the competent authorities for the environmental and public health monitoring or municipality section for environmental services rev 4 01 06 2005 16 30 DU5051114 Sirio S2 T f Service Manual 6 1 SERVICE This chapter is expressly intended for SIARE qualified personnel or for qualified technical personnel officially authorized by SIARE to maintain the SIRIO S2 T and it 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
24. s should be made as per the procedures described in chapter 4 Norms SIRIO S2 T is a lung ventilator manufactured according to the following norms 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 64 4 Electrical Installation in locations used for medical practice IEC 601 4 Programmable devices ISO 5356 EN 1281 Connectors Dir 93 42 Medical devices Dir 89 336 CEE Electromagnetic compatibility rev 4 01 06 2005 6 30 DU5051114 Sirio S2 T f Service Manual 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 o
25. th the operative modes selector Set the following parameters Rate 15 BPM High Press limit 20 cmH20 Minute volume 9 LPM PEEP 20 cmH20 Verify that the airvays pressure manometer indicates between 35 cm H20 and 45 cmH20 as pressure and 20 2 cmH20 as end expiration level 6 Verify the operative mode CPAP Select the CPAP operative mode with operative mode selector Set the following parameters High Press limit 10 cmH20 Verify that the airway pressure gauge indicates 10 1 cmH20 High Press limit 20 cmH20 Verify that the airway pressure gauge indicates 20 2 20 DU5051114 19 30 rev 4 01 06 2005 Service Manual f Sirio 52 Verify the RATE Connect the patient circuit to the HIGH FLOW range inlet of flow analyzer unit Set the following parameters Operative mode AUT AST High Press limit 50 cmH2O Minute volume 9 LPM Verify that the following setted frequencies RATE are within the corresponding acceptance limits read on flow analyzer unit Setted Rate Lower acceptance limit Upper acceptance limit values read on flow analyzer unit values read on flow analyzer unit wa Verification the oxygen mixer Connect the O2 Set the following parameters Operative mode AUT AST Rate 715 High Press limit 50 cmH20 Minute volume 9 LPM Set the following conc values and verify that the value read on referring oxymeter is within
26. the corresponding acceptance limits Setted O conc O conc Lower acceptance limit O conc Upper acceptance limit w m Verify the power supply failure power supply failure alarm Set the AUT operative mode AUT AST Disconnect the electric power supply Verify that ON LINE led switch off and that ON BATT leds switch on the ventilator continues working When the battery is low the red led lights on with consequent not resettable acoustic alarm indicating a 5 minutes operation left rev 4 01 06 2005 20 30 DU5051114 Sirio S2 T f Service Manual 10 Verify the bronchomanometer AN Connect the patient circuit by a T to patient simulator and to inlet of flow analyzer unit with PEAK option Set the following parameters Operative mode AUT AST Rate 15 Act on Volume Minute knob so to display on ventilator manometer the following peak pressure and verify that the values displayed on flow analyzer unit are within in corresponding acceptance limits Setted pressure Lower acceptance limit Upper acceptance limit read on flow analyzer unit read on flow analyzer unit e mn 11 Verify leakages absence Leakage test from valves group to the patient low pressure circuit leakage Connect the patient circuit to a patient simulator Set the following parameters Operative mode AUT AST or PCV or PSV in Apnoea BACK UP RATE 5 Verify that on venti
27. to pressure transducer and verify that the device displays around 3 1 Volts 6 1 2 Pneumatic calibration ee Nea fF ON 11 12 13 Connect the compressed air source at 4 bar Completely open FR1 Minute Volume Position the mixer on 50 Connect the Flow Analyzer unit to the inspiratory connector Activate CPAP mode Calibrate the PR1 pressure regulator until obtaining a flow of 40 5 l min Verify all FR1 regulator scale eventually adjust the indicator position Open the FR2 regulator Pressure Limit at cmH O Always in CPAP mode connect the lung simulator and close FR6 until obtaining 20 cmH20 on simulator Verify all the FR2 regulator scale eventually adjust the indicator position Regulate FRS at 20 l min Flow Analyzer Tester with the mixer on100 Verify all the FR7 regulator scale eventually adjust the indicator position Regulate FRS at 40 l min Flow Analyzer Tester with the mixer on100 6 2 Testing Perform the following connections Connect the electric power cable to the equipment and to the main power supply Connect the compressed air at 3 5 bar to O inlet Connect the patient circuit of 120 cm to the equipment and patient simulator Verify the external aspect Verify if the equipment shows damages bruises electric cable and pneumatic circuits and broken parts or any other kind of defect concerning each external component of the unit Verify if all the fixing nuts are correctly positioned and
28. ust 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 N SIARE declines all responsibilities arising from technical intervention performed on the 1 1 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 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 e continuous flow CPAP e automatic ventilation through a time cycled breathing activity synchronized with the patient s spontaneous activity AUT AST e assisted with pressure support PSV Pressure Support Ventilation Among the default functions the following can be adjusted e breathing cycle frequency in AUT AST mode Fix Ratio 1 1 5 delivered minute volume or flow e airway pressure limit in AUT AST mode pressure support level in PSV e oxygen concentration MIXER 50 or 100 SIRIO S2 T measures and displays e instant airways pressure
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