Saime Helia S Ventilator Service Manual
Contents
1. maximum current of 5A and for a duration of over 1 hour non stop 12 7 Technical properties of BACTINYL 5M v v BACYINYL 5M is a concentrated disinfectant SPORICIDE FUNGICIDE BACTERICIDE and VIRUCIDE BACYINYL 5M is used with clean materials which has been decontaminated beforehand with soapy water 12 7 1 Instructions for use Prepare an immersion bath at 296 for products not ready to be used in cold or lukewarm water Completely immerse the equipment to be disinfected both the patient circuit and the removable unit Leave it in the water for 15 minutes Rinse with sterile water or water with low bacteria count and let dry 12 7 2 Caution Do not use with other products Do not swallow SAIME NTA0005042 b Page 12 31 Service Manual HELIA S v Rinse with clear water if the product is in contact with skin or eyes Information for surface disinfecting Saime recommends BACTINYL FUNGICIDE BACTERICIDE and VIRUCIDE The F GARCIN pharmaceutical laboratories manufacture BACTINYL 63000 CLERMONT FERRAND FRANCE Page 12 32 SAIME NTA0005042 b Service Manual HELIA S Appendix 1 Applicable Diagrams e Electrical wiring diagram 99 040 CAB E e CPU electrical layout diagram 99 040 CPU E e Wiring diagram for pneumatic circuit 99 040 CAB P SAIME NTA0005042 b Page 12 33 Notice technique HELIA S Appendix 2 Symbols Type B device Please read the supplied documentation z E AC volt2. ANTI HRE f Fuile ajustable SORTIE INSUPPLATION 3 PATIENT VERS PA se gang s OV ES z EZ CLAPET ANT RETOUR TALE VALY COMMANDE DE VALVE i REGULSTEUR mil PUITE BLOC SOUPAPE __ ee ANHIANT ELECTHOYANNE EXPIRATION SAIME NTA0005042 b Page 1 1 Service Manual HELIA S 1 2 Synoptic translation Afficheur gay Alimentation continue Alimentation exterieure External power supply Keyboard Comande moteur Motor control Motor Motor Regulateur PEEP PEEP regulator Page 1 2 SAIME NTA0005042 b Service Manual HELIA S Retour Expiration patient Patient exhale return Selection pression debit Sortie des Gaz expires Exhaled gas output Sortie insufflation vers patient Valve expiratoire Exhale Valve SAIME NTA0005042 b Page 1 3 Service Manual HELIA S 2 OPERATING PRINCIPAL 24 Principle v The pneumatic system is based on a supply head and pneumatic block v The supply head is driven by a brushless DC motor The supply sucks in the surrounding air and passes it through a filter The pneumatic block either distributes the air to the patient the insufflation cycle or else blocks off the gas during the expiration cycle v The pressure delivered by the ventilator during the inhale cycle depends on the rotation speed of the supply head v The Positive End Expiratory Pressure PEEP is determined via a compressor and a pneumatic regulator v Non return safety valves ensu
3. cone 15mm diameter female cone and 22mm diameter female cone Ny NO RUN A Note the filter usage life is 24 hours if used as a viral bacteria filter 12 4 Oxygen supply v Accessory Grooved on line female coupler diameter 4mm ref PMC17 02 CPC coupler v Oxygen supplied from both bottles and wall taps should be limited to 4 bars If this is not the case use a pressure reducer v The oxygen flow rate should be adjustable up to 10 litres per minute and the oxygen pressure as measured at the flowmeter s nozzle should be less than 100 kPa Page 12 30 SAIME NTA0005042 b Service Manual HELIA S 12 5 Heating chambers NG NG NG Ny Ba NG By NA RUN Recommended types MR 250 Maximum volume 0 5 litre Flow rate 180 litres minute Liquid flow rate from 10 to 25 mgllitre Maximum service pressure 5 80 hPa Pressure drop at 180 litres minute lt 3 hPa Pressure drop under conditions of natural breathing lt 3 hPa Gas Loss At Maximum Pressure lt 20 ml minute Average compliance 0 3 to 0 5 ml hPa All equipment must have the EC label Complete circuit characteristics including humidifier v Complete pneumatic system Average volume 1 4 litre Average compliance 1 ml hPa v Circuit Average volume 1 4 litre Average compliance 1 ml hPa 12 6 External DC Power Supply v v The material used must have the EC label The external power supply must be capable of supplying a 24 DC voltage with a
4. of the patient s clinical state Faulty sensor Patient occlusion Change of the patient s clinical state Faulty sensor Patient circuit leaks Partial patient circuit occlusion Patient disconnected Leaks on the endotracheal sensor DC power pressure circuit pressure or the balloon has deflated Alarm level setting not correct Change of the Check fuses F1 F2 and the mains fuse Reconnect the mains or external DC supply Use an alternative means of ventilation Check fuses F and F1 Check the mains cable Run the ventilator from the back up supply unit Make sure the DC source is connected Check fuse F2 Replace charge the external supply Check the cable Check replace the fuses of the external DC supply Run the ventilator from the mains Eliminate leaks Reconnect the patient Adapt the settings to the patient s new clinical condition Call maintenance if the problem persists Eliminate the source of the occlusion Adapt the settings to the patient s new clinical condition Call maintenance if the problem persists Eliminate the source of the leaks Make sure that neither the patient circuit nor the intubation sensor do not contain any excessive resistances and the patient s air passage is not blocked Check the balloon sensor and pressure Check the level of the SAIME NTA0005042 b Service Manual VT max Discontinuous sound a
5. pneumatic test set for an inspiratory volume control of about 0 6 litre Set Vt minimum on 2 5L The INSUFFICIENT TV alarm goes on Block the minimum volume alarm Press the Alarm Off button Set Vt maximum on 0 5L The EXCESS TV alarm goes on Block the maximum volume alarm Press the Alarm Off button Turn off the ventilator without pressing the Alarm Off button The general power cut off continuous sound alarm is activated Press the Alarm Off button NY NG ING NO NUN NN a YEN NN SAIME NTA0005042 b Page 8 19 Service Manual HELIA S 9 ADJUSTING THE VENTILATOR SETTINGS Warning The following settings may only be adjusted if the ventilator s memory containing the various settings has been unlocked This should only be done by trained personnel with the required test material test lung spirometer pressure gauge endotest 9 1 Technical Access 9 1 1 To access the technical menu v Press the Alarm Off button and then very quickly the On Off button The technical menu displays on the screen and the supply head stops v Press the ventilation modes buttons to scroll the technical menu left or right v Asetting has to display on the top left of the screen before it can be adjusted 9 1 2 To leave the technical menu v Press the Alarm Off button and then very quickly the On Off button v The technical menu disappears from the screen and the ventilator starts up again Note if Helia S is turned off without ha
6. the V2 4 CPU version This modification doesn t require the update of the previous versions Improvement of automatic detection of simple double circuit uncertain release of low pressure alarm V2 6 Available Update of CPU version poorer or equal to V2 3 This modification doesn t require the update of the previous versions Improvement of useful life of O cell measure bracket V2 51 HEL0301016 This modification doesn t require the update of the previous versions Improvement of useful life of O cell measure bracket Update of CPU version poorer or equal to V2 3 veo aa modification doesn t require the update of the previous versions Modification of connection between CPU and display by flat cable Improvement of the connection s resistance to vibrations Application from ventilator HEL0107034 This modification doesn t require the update of the previous versions Modification of the fixed pneumatic bloc on Helia 2 electro valves instead of 3 Optimization of expiratory resistance with a single electro valve Application from ventilator HEL0204025 This modification doesn t require the update of the previous versions Modification of mains supply New mains bloc Optimization of EMC more manual settings Application from ventilator HEL0207033 This modification doesn t require the update of the previous versions gt HELIAS e Modifications Version of Applied to Subject program Serial number Modi
7. 10 hPa After 3 cycles check the expiration pressure is indicated by the bargraph by 5 1 squares If the expiratory pressure is out of this range follow the instructions SNS Adjust PEEP 0 Go to the technical menu Select AJ PR setting to increase or decrease the PEEP value Leave the technical menu Follow the procedure as above indicated to check the settings at 5 and 10 hPa 9 5 Adjusting the inspiratory volume NN ON K Hook up the ventilator to a test lung with a resistance Rp20 and a compliance 0 05 Connect a spirometer to the lung s entrance Adjust the following settings PCV PS 20hPa PEEP 0hPa FREQ 16 Tins 1 2s Make sure that the inhale volume measured by the ventilator corresponds to the volume measured by the spirometer at 0 03 litre If the volume setting is not within the range enter the technical menu select the I VOL setting to increase or decrease the inhale volume as required then leave the technical menu and check the setting 9 6 Adjusting the display contrast v v Remove the back cover from the ventilator Start the ventilator and use the POT1 potentiometer on the CPU to adjust the contrast SAIME NTA0005042 b Page 9 21 Service Manual HELIA S 10 FUNCTIONAL DIAGRAMS THE PNEUMATIC CIRCUIT 10 1 Inspiration cycle BLECTROYANNE AIR ANBIANT INSPIRATOIRE SORTIE JMJURRLATJOM COMMANDE DE YALYE EXPIRATOIRE BLECTROYANNE EXPIRATION gt HELIA S inspiration cycl
8. INDER HELIA S 4 1 Ventilation settings chart s Ventilation modes Settings Adjustment Adjustment Display Control Notes 9 range increment precision precision psy PSV PCV APCV F PS 05 to 60hPa 1 hPa 1hPa 0 54 hPa Yes Yes Yes Yes PEEP 00 03 to 1 hPa 1hPa 1hPa Yes Yes Yes Yes 12hPa FREQ 05 to 60 1 1 10ms Yes No Yes Yes Set to SV for sponta cycles min neous ventilation TRIGGER 01 to 10 1 1 0 54 hPa Yes Yes No Yes Set to CV in PCV mode FIN I 05 to 90 or 1 1 5 Yes Yes No No AUTO Tins 0 5 to 3 5s 0 1 s 0 1 s 20 ms No No Yes Yes SLOPE 00 to 02 1 1 without Yes Yes Yes Yes 4 2 Delivered minute volume The minute volume delivered to the patient by the ventilator depends on the ventilator settings Pressure level Frequency Inspiratory time and the physiological traits of the patient resistance 4 compliance With PS 40hPa et a measured l E 1 2 results are Minute volume delivered Minute volume delivered Compliance for a resistance calibrated for a resistance calibrated Rp20 2 0 cm H2O litre s Rp5 0 5 cm H Ollitre s 0 03 L cm H20 23 litres 43 litres 0 04 L cm H20 24 litres 44 litres 0 05 L cm H20 24 litres 45 litres 0 06 L cm H20 25 litres 46 litres 0 07 L cm H20 25 litres 46 litres SAIME NTA0005042 b Page 4 7 Service Manual HELIA S 4 3 Me
9. active in 2 ways Helia S not plugged onto the mains display and fast buzzer can not be inhibited Helia S plugged onto the mains display and normal buzzer with silence alarm function available Notes v The non inhibited alarm is released if the external supply tension is lower than 21 5V for at least 5 seconds The inhibited alarm is released if the external supply tension is in between 21 5 amp 22 5 V or higher than 29 V for at least 5 seconds v This alarm system is particularly suitable for external battery packs SB Helia supplied by Saime SAIME NTA0005042 b Page 5 11 Service Manual 5 5 Alarms Summary table HELIA S Report Continuous sound alarm Complete ventilator stop No message MAINS Discontinuous sound alarm Mains electricity a supply failure EXTERNAL POWER External DC supply failure Discontinuous sound alarm LOW PRESSURE or APNEA Low Inspiratory pressure Discontinuous sound alarm HIGH PRESSURE High Pressure Discontinuous sound alarm VT min Low inspiratory a tidal volume Discontinuous sound alarm Page 5 12 General electricity failure Mains failure Mains cable has fallen out or is defective External failure External DC voltage insufficient or the batteries of the external DC source discharged Cable has fallen out or is defective External DC supply faulty Patient circuit leaks Patient disconnected Change
10. age DC voltage Class II Complies with EC standards Fragile w Store and transport this side up Keep away from water 4 oh Alarm off button Gas output toward patient Exhale valve control SAIME NTA0005042 b Page 12 35 Please refer to the HELIA S Service Manual for the Assembling Disassembling related to the maintenance HELIA S Maintenance designation reference Air filter FIL009663 Micropump S E009683 Turbine 120 Mbar ELE008886 Expiratory valve CLA007829 Inspiratory valve CLA007235 PNEUMATIC BLOC O RINGS KIT010152 O ring 32x2 JO1007256 O ring 33x2 JO1009333 Silicon valve SOU009078 Electrovalves S E009345 HELIA S PEEP Micropump MICROPUM SP 250 EC MICROPUMP FOAM SINGLE MICROPUMP FOAM MICROPUMP FOAM COVER HELIA S Pneumatic block 6 VALVE UNITBRIDLE BRI00840 s J EXPIRATORY VALVES CLA007829 9 1 INSPRATORYVALYWE as HELIA S Turbine FOAM wwrrrro EXIT CONNECTOR RANGE WASHER O RANGE WASHER 8 4 M4STEELWASHER 9 4 M4NYLONWASHER Z 10 BLOC SILENT SUPERIOR TURBINE M3X6 CRUCIFORM SCREW Sr INFORMATION PRODUCTS MODIFICATIONS HELIA 2 S gt HELIA 2 e Modifications Version of Applied to Subject program Serial number Improvement of automatic detection of simple double circuit uncertain release of low pressure alarm V2 5 HEL0206088 Update of
11. asured parameters v 5 measured parameters are available Maximum pressure bargraph Machine operating time when the ventilator is turned on Frequency I E ratio inspired Vt automatically displayed when no button has been activated for 6 seconds v The measured parameters display automatically when the ventilator is turned on v If the operator displays the ventilation settings and then touches no button for 6 seconds the measured parameters are automatically displayed again Measured Adjustment Adjustment Display Notes parameter Range increment precision Sensor tip Pmax xxhPa 0 to 76hPa 0 54hPa pressure at insufflation Frequency xx min 0 to 99 1cycle min cycles min VE 1 xx___ 1 0 1 to 1 9 9 Vti x xxL 0 00 to 4 00 L Full range saa 5 volume control Error at low average volumes volume over 2 0 05L cycles CLOCK xxxxHww 0 to 10 ms 1 minute Machine 99999H99 operating time 4 3 1 Pressure sensor characteristics v The DCAL 430 GN sensor is a differential pressure sensor 76 hPa consisting of a compensated and amplified piezo resistive bridge with a ratiometric output voltage v The pressure measurement precision of 0 54 hPa characteristics of the sensor and the processing chain This precision is defined for the linear zone O to 76 hPa However the sensor gives returns pressure readings up to 85 hPa 4 3 2 Flow Rate sensor characteristics v The AWM3201CR sensor is a differential
12. boxes Storage temperature from 5 to 60 C Do not store in humid conditions SASS The ventilator is fragile it should be handled with care The ventilator should be stored as it is used i e in a vertical position on all legs 11 6 2 The ventilator and its accessories are not in original boxes Storage temperature from 5 to 60 C Do not store in humid conditions SILA 11 7 Transport conditions The ventilator is fragile it should be handled with care The ventilator should be stored as it is used i e in a vertical position on all legs v The ventilator and its accessories should be placed in their original SAIME packaging for transport v Transport temperature 5 C to 60 C 11 8 Materials used The materials used in the ventilator are In contact with the inspired air In contact with breathed oxygen AutoT ext Rubber Polyester Aluminium Stainless steel Brass Delrin Silicon KIN NYT NS SLA Foam PPI 80 polyester 11 9 Fire prevention For a ventilator in first fault condition and an oxygen input set at 10 litres per minute the oxygen concentration inside the ventilator is Page 11 28 SAIME NTA0005042 b Service Manual HELIA S v Less than 24 1 for a stopped ventilator v Less than 22 4196 for a working ventilator For a ventilator in first fault condition the inflammable materials cannot reach their ignition
13. e Page 10 22 SAIME NTA0005042 b Service Manual HELIA S Inspiration cycle Translation chart BLOC SOUPAPE VALVE UNIT Capteur de debit expiratoire Exhale rate sensor Capteur de debit inspiratoire Inhale rate sensor Capteur de Pression 26 PC 26 PC pressure sensor Command de valve expiratoire Exhale valve control Fuite Leak Sortie insufflation vers patient Insufflation output toward the patient Supply Head Valve Valve SAIME NTA0005042 b Page 10 23 Service Manual HELIA S 10 2 Expiration cycle gt HELIA S expiration cycle Page 10 24 SAIME NTA0005042 b Service Manual HELIA S Expiration cycle Translation chart BLOC SOUPAPE VALVE UNIT Capteur de debit expiratoire Exhale rate sensor Capteur de debit inspiratoire Inhale rate sensor Capteur de Pression 26 PC 26 PC pressure sensor Command de valve expiratoire Exhale valve control Filtre poussieres Dust filter Fuite Leak Supply Head Valve SAIME NTA0005042 b Page 10 25 Service Manual HELIA S 11 TECHNICAL SPECIFICATIONS 11 1 Ventilator specifications Pulmonary ventilator HELIA Pressure Support Barometric adult children WON 11 2 Power Supply HELIA S is a Class II b ventilator 11 2 1 Mains v 230V AC 50Hz 2A maximum 80 VA v Fuses T 2A H250V and T5A H250V 11 2 2 External supply v 24V DC 2A maximum v Fuse T2 H250V 11 3 Performances v Maximum pressure delivered by the supply head in first fault c
14. e the pressure and flow rate sensors Check the voltages 24V 12 V 5V and the DC supply Check the voltage of the CPU back up battery gt 3 6 V Check the fuses Bl NG Tr RO KA AG NN ES At 12000 hours added to 4000 hours checking v Fita new supply head v Fit a new PEP compressor This maintenance schedule shall be carried out following the indications provided by Saime It is recommended to attend Saime technical trainings in order to get the maximum capability Note unless otherwise mentioned Helia S should be turned off for all internal handling Also the checks should be made only by correctly trained and qualified personnel Page 7 16 SAIME NTA0005042 b 8 1 8 Service Manual HELIA S CHECKING THE VENTILATOR Checking the pneumatic circuit 8 1 1 The pneumatic block To remove the pneumatic bloc NG NG NG NG NIN Then 8 2 NONG SS SSS SSS Remove the back cover Disconnect the electric leads and pneumatic tubes coming into the block Unscrew the front panel Take off the front cover Unscrew the supply head Disconnect the tube leaving the supply head and unscrew the screws on the front of the block Check the non return valves Disassembly the 2 pneumatic chambers and check the valves and seals Make sure the nipples are tight Make sure the electrovalves are tight Replace faulty parts and put the unit back together again 8 1 2 Pneumatic circuit tubes Check the tube b
15. e ventilator Using a different mains cable could be dangerous for the patient 8 2 4 Checking the voltages on the CPU board The DC voltage between the pins 2 and 14 of the test connector should be 5V 0 2V The 12 Volts between the pins 3 and 14 of the connector test should be 12V 0 02V The 5 volt reference voltage between the pins 4 and 14 of the J8 connector buzzer side should be 5V 0 05V 8 3 Checking the ventilator 37 NG NG INANI ING NG NW SATA BR SY Take off the ventilator s back cover Start the ventilator from the mains with a pneumatic circuit connected Leaving the mains connected supply the machine with a 24 V DC supply Disconnect the mains The Mains alarm goes on Press the Alarm Off button Plug the mains back in and remove the DC supply The External DC Supply alarm goes on Press the Alarm Off button Go to the PCV mode and set PS 20 hPa FREQ 16 Tins 1 2s Disconnect the pneumatic tube at the insufflation input The Low Pressure alarm goes on Reconnect the pneumatic tube at the insufflation input Press the Alarm Off button Disconnect the tube on the pressure sensor MPXL5010 at the back of the ventilator but pinch the tube closed so as to keep the ventilator working correctly Apply a pressure of over 20hPa to the pressure sensor Page 8 18 SAIME NTA0005042 b Service Manual HELIA S The High Pressure alarm goes on Reconnect the pneumatic tubes Press the Alarm Off button Adjust the
16. essure v If after 0 5 seconds the pressure exceeds 10 hPa the alarm goes on Note if after 1 second the pressure still exceeds 10 hPa the ventilator switches to automatic expiration 5 2 Adjustable alarms Adjustable setting Adjustment range Message displayed Min Vt level No 0 1 to 2 9L Insufficient Vt alarm Max Vt level 0 1 to 4 0 L No Excess Vt alarm 5 3 Signalling alarms When an alarm goes on v The red alarm LED goes on v A discontinuous beep is heard v The alarm message blinks on the screen Page 5 10 SAIME NTA0005042 b Service Manual HELIA S If the operator presses the Alarm Off button v The audible alarm stops for 2 minutes except for the MAINS alarm or the EXTERNAL POWER alarm v The red LED continuously goes on v The alarm message blinks on the screen If the source of the alarm disappears v The red LED goes off v The sound signal goes off v The alarm message displays without blinking on screen alarm stored in memory as long as the Alarm Off button hasn t been pressed 5 4 Alarms operation 5 4 1 Mains v The MAINS alarms means the power supply failure v The audible alarm disappears if a correct tension is back In this case the message is memorized and displayed on screen v Pressing the Alarm Off button makes it disappear 5 4 2 External supply v The EXT PWR message means a loss of external supply lt is never release when the ventilator is turned on v Itcan be
17. etween the supply head and the block Check the pneumatic tubes as per the pneumatic circuit diagram 99 040 CAB P Connect the ventilator to a test lung with a resistance Rp20 and a compliance 0 05 Fit a pressure gauge to the pneumatic circuit Make the settings PCV PS 40hPa PEEP 0hPa FREQ 16 Tlns 1 2 Check the pressure rise in the ventilator Electrical Circuit Checks 8 2 1 Checking the fuses Turn off the ventilator The fuse of the mains connector is a T1 2AH250V fuse 1 25A time lagged and protects from overload The fuse labelled F2 on the PCB is a T4AH250V 4A time lagged This is the secondary transformer fuse and protects from overheating The fuse labelled F1 on the PCB is a T2AH250V 2A time lagged This fuse is connected to the external DC power supply and protects from overload SAIME NTA0005042 b Page 8 17 Service Manual HELIA S Note all defective fuses should be replaced with identical fuses respecting identical norms SSS 8 2 2 Checking the LED Connect an external source between 24 volts minimum and 26 volts maximum and make sure that the External V LED on the front panel lights up Start the ventilator and check the LED for each of the ventilation modes the Alarm LED and the trigger LED 8 2 3 Electrical wiring Remove the back panel Check the electrical wiring as per the wiring plan 99 040 CAB E Make sure that the ventilator is being run from the specific cable delivered with th
18. fication of time counter writing uncertain release of pressure alarm V 1 07 HLS0207003 Update of V1 06 CPU version This modification doesn t require the update of the previous versions Modification of time counter writing untimely release of pressure alarm V 1 08 Available Update of CPU version poorer or equal to V 1 05 This modification doesn t require the update of the previous versions Modification of connection between CPU and display by flat cable Improvement of the connection s resistance to vibrations Application from ventilator HLS0108015 This modification doesn t require the update of the previous versions
19. is alarm is turned off by pressing the Alarm Off button v The DC supply fails If the DC supply fails but the mains keeps running an alarm goes on and a EXT PWR message is displayed This alarm is turned off by pressing the Alarm Off button v The mains supply fails If the mains supply fails but the DC power keeps running an alarm goes on and a MAINS message is displayed This alarm is turned off by pressing the Alarm Off button s NOTE The external power supply must have a runtime of at least one hour SAIME NTA0005042 b Page 2 5 Service Manual HELIA S 3 OXYGEN SUPPLY REMINDER Synoptic Oxygen source Flowmeter HELIA S oxygen input Wall bottle oxygen 100 kPa max concentrator liquid OEM 100 kPa max oxygen 10 L min max v Oxygen source must be connected to the oxygen input identified on the front face by the symbol 6 v Oxygen source shall provide maximum pressure 100kPa maximum adjustable flow 10 L min v Accessory Grooved on line female coupler diameter 4mm ref PMC17 02 CPC coupler ref COU006231 Note 1 with a maximum oxygen flow of 10 L min Helia S can accept FiO2 from 21 to 70 Note 2 Helia S does not feature any oxygen monitoring system Oxygen concentration is regulated by an external flowmeter Warning if the oxygen pressure is higher than 1 bar a pressure reducer must be used Page 3 6 SAIME NTA0005042 b Service Manual 4 VENTILATION SETTINGS REM
20. larm TECHNICAL Discontinuous sound alarm Excessive inspiratory volume tidal Technical problem a with the ventilator SAIME NTA0005042 b patient s clinical state Faulty flow rate sensor Patient circuit leaks Alarm level setting not correct Change of the patient s clinical state Faulty sensor flow rate Pressure sensor and or supply head control faulty HELIA S alarm Adapt the settings to the patient s new clinical condition Call maintenance if the problem persists Eliminate the source of the leaks Check the alarm Adapt the settings to the patient s new clinical condition Call maintenance if the problem persists Use an alternative means of ventilation Call maintenance if the problem persists level of the Page 5 13 Service Manual HELIA S 6 CLEANING AND STERILISING Warning The ventilator should be cleaned and disinfected as described in the technical notice if the ventilator is being used for the first time or is being used on a new patient 6 1 Maintenance frequency The disposable ventilator elements should be cleaned or replaced in accordance with either the manufacturer s instructions or the medical policy in operation on the place of use However the table below gives Saime maintenance frequency for the pneumatic circuit elements Element Interval New patient Frequency given by Frequency given constructor paa A medical staff Patie
21. nt circuits Ye Yes Heating chamber Bacteria filter Yes Yes Yes 6 2 Patient circuit v Reusable patient circuit elements should be disinfected and cleaned as per the manufacturer s recommendations v The reusable patient circuit should be regularly cleaned with soapy water rinsed with clear water and dried before re use v This basic maintenance procedure is recommended for home ventilation on one single patient v Only silicon tubes and valves are autoclavable v Cold disinfecting by immersion is also possible use the BACTINYL 5M solution 6 3 Bacteria filter v Bacteria filters used for bacterial and viral filtering should be replaced in accordance with manufacturer s instructions and whenever a new patient is connected v Filters used to filter dust should be changed every 500 hours 6 4 External unit parts v The external parts of the ventilator can be cleaned with a dry cloth or if necessary a slightly wet sponge v Do not use abrasive powders alcohol or solvents Page 6 14 SAIME NTA0005042 b Service Manual HELIA S 6 5 Heating chamber Note we recommend using disposable chambers v Disposable heating chambers should not be put into an autoclave v Also they should not be used with solutions containing phenol ketone formaldehyde hypochloride chlorinated hydrocarbons aromatic hydrocarbons and organic acids v Cold decontamination by immersion is also possible for reusable chambers use a 2 o
22. nt de Materiel Medical Medical Device Manufacturer HELIA S PRESSURE SUPPORT PULMONARY VENTILATOR Service Manual Ref NTA0005042 b SAIME S A 25 rue de I tain 77176 Savigny le Temple T l 101 64 19 1111 Fax 01 64 41 81 30 Service Manual HELIA S WARNING This Service Manual may be used as a complement of Helia User s Manual It is therefore compulsory to have read and understood the User s Manual prior to the lecture and understanding of the Service Manual Helia S settings should be made by professionally trained and competent personnel working under a doctor s responsibility Helia S settings exclusively depend on a doctor s medical prescription Page II SAIME NTA0005042 b Service Manual HELIA S Contents 1 FUNCTIONAL DIAGRAM 1 1 B OXYGEN SUPPLY REMINDER 3 6 4 VENTILATION SETTINGS REMINDER 7 4 1 7 4 RAZOWA NNS AA 4 SAIME NTA0005042 b Page III Service Manual CLEANING AND STERILISING Page IV SAIME NTA0005042 b Service Manual HELIA S 12 TECHNICAL SPECIFICATIONS FOR THE VENTILATOR ACCESSORIES 12 30 Appendix 2 Symbols 12 35 SAIME NTA0005042 b Page V Service Manual HELIA S 1 FUNCTIONAL DIAGRAM 1 1 Synoptic CLAVIER VENTILATEUR AFFICHEUR ALINENTA TION SELECTION CONTINUE DES TENSIONS TRANSFORNATEUR CONNAN DE NOTEUR SECTEUR ELECTROVANNE NR AM INSFIRATOIRE PILTRE A eZ POU SSIBRE mum mal TURBINE CLAPET
23. ondition lt 80 hPa v Maximum adjustable pressure 60 hPa Pinsp PEEP v Maximum pressure delivered by ventilator under normal operating conditions lt 70 hPa v Flow rate at 40 hPa 240 litres per minute the flow rate is limited to 240 litres min v Ventilator compliance not measurable depends on elasticity of air HELIA S has the following specifications with the filter circuit and humidifier Page 11 26 SAIME NTA0005042 b Service Manual HELIA S v Volume 0 9 to 1 8L v Compliance 1 3 to 1 5 ml hPa v Inspiratory resistance lower than 6hPa at 60L min Pressure losses in the pneumatic circuit Flow rate Maximum inspiratory in litres per minute resistance in hPa 11 4 Conditions of use v Operating temperature 410 to 40 C v Relative humidity 10 to 75 v Pressure 600 to 1100 hPa 11 5 Ventilator operating limits Any one of the following 5 conditions would be considered an operating limit Ambient temperature from 5 C to 50 C Ambient relative humidity from 10 to 95 Atmospheric pressure from 600 to 1100 hPa Mains voltage deviating 20 to 10 from the nominal value External supply tension from 20 to 410 for an external tension lower than 24VDC 10 21 6V the external supply alarm is released A combination of 45 C and 75 RH SAKSA SAIME NTA0005042 b Page 11 27 Service Manual 11 6 Storage conditions HELIA S 11 6 1 The ventilator and its accessories are in original
24. pressure sensor 1 25 hPa with a 4 20mA output current v The flow rate precision depends on the characteristics of the pressure loss sensor used v The sensor gain in Litres sec x pressure gives the precision in litres s Page 4 8 SAIME NTA0005042 b Service Manual HELIA S 4 3 3 Measuring the inspiratory volume control v The measurement is given under ATPD conditions i e ambient temperature and pressure conditions and dry air no water vapour v The volumes can be considered acceptable down to 0 1 litre However at low volumes from 0 1 litre downwards the volume reading error is 0 05 litre i e 5096 of 0 1 litre SAIME NTA0005042 b Page 4 9 Service Manual HELIA S 5 ALARMS 5 1 Automatic not adjustable alarms Sorted by decreasing priority General Electrical Power Cutoff alarm MAINS Mains Failure alarm LOW PRESSURE except in PSV mode without frequency HIGH PRESSURE HIGH FREQUENCY TECHNICAL internal technical problem EXTERNAL POWER external DC power supply failure SARACEN 5 1 1 Low Pressure Alarm v This alarm has been programmed to go on at 3 hPa below the set ventilation pressure v If after 5 respiratory cycles the pressure is insufficient the alarm goes on Note this alarm does not exist in spontaneous ventilation mode but is replaced by APNEA alarm 5 1 2 High Pressure Alarm v This alarm has been programmed to go on at 10 hPa above the set ventilation pr
25. r 4 BACTINYL instrumentation liquid soap solution v Should you wish to disinfect an element after decontamination use a 2 BACTINYL 5M solution Follow the same procedure as for the BACTINYL instrumentation liquid soap Note maintenance centres may use other decontamination procedures However they must be approved and respect current rules and regulations Warning if other products are used they must respect the conditions detailed in the French Pharmacopoeia they must guarantee the absence of all residual products and they must not interfere with the ventilator s operation Furthermore they must not be in contradiction with the security measures recommended by Saime SAIME NTA0005042 b Page 6 15 Service Manual HELIA S 7 MAINTENANCE AND PREVENTIVE INSPECTIONS Assuming the ventilator is used in normal operating conditions the following procedure is recommended v The alarms should be regularly checked especially before connecting a new patient v The pneumatic circuit should be checked before connecting a new patient v The dust filter should be regularly replaced The following schedule recommends time tabled technical interventions At 4000 hours or 1 year Check the alarms Check the LED light displays Replace the valves the non return valves and the O seals on the pneumatic block Check the internal pneumatic circuit for leaks Check all connections mechanical behaviour insulation Calibrat
26. re that the patient can breath freely through the ventilator 2 2 Microcontroller The microcontroller on the Central Processing Unit CPU manages v The ventilation cycles frequencies inspiration times by means of the inhale and exhale electrovalves The pressure level by means of the supply head and pressure sensor readings The Positive End Expiratory Pressure PEEP by means of the compressor The inhale trigger by means of the pressure sensor The exhale trigger PSV 8 PSV F modes by means of the inhale flow rate sensor pressure loss type sensor Man machine interface communication keyboard LED display etc The alarms buzzer Power supply source switching KN KN SSR 2 3 Current supply possibilities v The Helia S may be run either from the mains 230 AC 50 Hz 1 25 A maximum n external DC supply between 24 VDC 2A maximum v The V EXT LED indicates the presence of the external voltage Note The two sources may be connected simultaneously in which case the ventilator will default to the mains supply Warning The Helia S has no internal battery It is wholly dependent on the mains and or the external DC supply With none of those power sources Helia S stops working However an audible alarm is released in such case Page 2 4 SAIME NTA0005042 b Service Manual HELIA S v Both Power Sources fail If both of these fail an alarm warns the user that the ventilator has stopped working Th
27. temperatures without setting off a high temperature alarm fixed at 50 C 11 10 Applied Standards The ventilator meets with the following standards EN 60 601 1 for electromedical devices safety rules IEC 601 1 4 for electromedical devices programmable systems EN 794 2 for pulmonary ventilators for use in the home EN 55 011 Class B EN 61 000 4 2 EN 61 000 4 4 EN 61 000 4 5 IEC 801 3 EC 0197 93 42 EC GM SNS NO NG NG NG KN SAIME NTA0005042 b Page 11 29 Service Manual HELIA S 12 TECHNICAL SPECIFICATIONS FOR THE VENTILATOR ACCESSORIES 12 1 Pneumatic circuits They must have the EC label Maximum internal volume of the circuit 800 cm3 for a single circuit The average compliance of the circuits must be less than 1ml hPa Maximum resistance 0 3 to 1 l s Resistances may not be higher than 6hPa at 60 litres for the adult and 6 hPa at 30 litres for children ANN KON Note to use a paediatric patient circuit a standard male male connector 22mm 15mm may be used 12 2 Gas input filter This filter is supplied by SAIME The dust filter is a PPI 80 foam pad Polyester foam with an 80 micron grid 12 3 Bacteria filter Recommended bacteria filter FILTA GUARD from INTERSURGICAL code 1944 Viral Bacteria filter Bacteria and viral retention greater than 99 999 Resistance at 60 litres minute 2 3 cm H2O Compliance non measurable air elasticity Compressible volume 66ml Connector 22mm diameter male
28. ving relocked the Technical menu it will automatically proposes the regular menu next time it will be turned on 9 2 Adjusting the Sensors The ventilator should have been running for one hour before the following adjustment is made v Use the ventilation mode settings to display the OFD1 in the adjustment zone v Use the rotating button in order to get DEB1 between 0000 and 0001 v Repeat the procedure for the settings OF PR PRES and OF PR2 PRES2 9 3 Adjusting the pressure DIV P Hook up the ventilator to a test lung with a resistance Rp20 and a compliance 0 05 Fit a pressure gauge to the pneumatic circuit Settings PCV PS 40hPa PEEP 0hPa FREQ 10 Tins 2s During the inspiratory phase check that the measured pressure is 40hPa 0 5 and that the bargraph contains 20 full squares If the pressure setting is not within the range select the P DIV setting in order to increase or decrease the level of pressure read then leave the technical menu and check the new setting Na NG DS Page 9 20 SAIME NTA0005042 b Service Manual HELIA S 9 4 Adjusting the Peep compressor v LA SN Hook up the ventilator to a test lung with a resistance Rp20 and a compliance 0 05 Fit a pressure gauge to the pneumatic circuit Adjust the following settings PCV PS 20hPa PEEP 5hPa FREQ 16 Tins 1 2s After 3 cycles check the expiration pressure is indicated by the bargraph by 2 5 1 squares Adjust the same settings but PEEP
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