VS Serena
Contents
1. EU HN TA S S M dU 20 eate oed 20 Modes es tee oe p edes se LL dades ee 21 6 1 Ihe mode Spontaneous Node G man SZ NO assesses ert patei teases 21 6 2 The ST mode spontaneous mode with minimum frequency f min gt 5 21 3 Ihe T s mode timed mode with 21 2 22 O 22 Parameters chart depending on the ventilation modes esses eene eee 22 7 3 UniS GIG CCL ACY EROR 23 IVC t Mmm 24 8 1 DIU C 24 AOE L TON 24 9 Muntenance and CCTION 25 9 PUE TUUM ME 29 9 2 DUSCFAHOE RA Edu UU c I 25 Replacement of hent ernal JUEN asco SEE PER Ete a mr 29 9 4 Check the COV ALON 25 NEAT0202079 K 12 31 User s Manual VS Serena 9 5 29 10 lechnical Characters 27 OIC2. COROI 1870 Certificate of conformity User s manual Recommendation concerning safe battery Tubes 180 cm 17 010993 Mains cord connection and claw Tube 1 80 m Vs Saime Bag NEAT0202079 K 8 31 User s Manual VS Serena Recommendations The Vs bi level has been made to work in an optimum way with different types of leaks masks present on the market The characteristics of those masks have been taken into account in the algorithms of calculations However the use of a facial mask can slightly modify the sensibility of the triggering In this configuration it is recommended to use the ST mode and the AUTO Start function disactivated NO With software version 2 04 we recommend the following RESMED masks when using an open circuit ventilation i e leakage 16518 KIT MASQUE MIRAGE STANDARD for PPC 16519 KIT MASQUE MIRAGE LARGE for PPC 16545 KIT MASQUE ULTRA MIRAGE PPC STANDARD 16546 KIT MASQUE ULTRA MIRAGE PPC LARGE 16578 ULTRA MIRAGE MASK SHALLOW WIDE CE 60003 ENSEMBLE MASQUE MIRAGE VISTA STANDARD 60004 ENSEMBLE MASQUE MIRAGE VISTA PROFOND 60103 MASQUE MIRAGE ACTIVA STANDARD 60104 MASQUE MIRAGE ACTIVA LARGE 60105 MASQUE MIRAGE ACTIVA SHALLOW 60011 MASQUE MIRAGE KIDSTA SML 632003 KIT COMPLET MASK PAPILLON TAILLE 1 632004 KIT COMPLET MASK PAPILLON TAILLE 2 LARGE 60610 MASQUE FACIAL ULTRA MIRAGE PETIT STD 6061 1 MASQUE FACIAL ULTRA MIRAGE PETIT SHALLOW 60612 MASQUE FAC
3. PUT 27 LOZ 28 IOS TOWT SUPP Y 28 HOA 28 TOD 29 10 0 3ApDhed 29 10 7 Accessories technical Specii cations sesenta 30 31 NEAT0202079 K 13 31 User s Manual VS Serena I Description and Assembling 1 1 Definition and field of application VS 15 a device used for the two pressure levels non invasive ventilation for adult or paediatric patients at hospital and or at home 1f the patient has enough spontaneous ventilation This device 1s not designed for neonatal use The device should be used with a single circuit system and a leaks mask The device has four leakage modes gt 5 Spontaneous ST Spontaneous with security frequency gt CPAP Continuous Positive Airway Pressure when EPAP IPAP T s Timed mode with frequency 1 2 Screen Buttons Opened padlock Type of used supply Menu Adjustment buttons Alarm Silence Alarm led Bargraph slope On Off 1 3 Patient circuit Connection Before starting the Bi level connect the patient circuit Insuf
4. User s Manual VS Serena R f NEAT0202079 K from version 2 04 Z I 25 rue de l Etain 77176 SAVIGNY LE TEMPLE FRANCE T l 33 0 1 64 19 11 11 Fax 33 0 1 64 41 81 30 33 0 1 64 41 8031 User s Manual VS Serena NEAT0202079 K 2 31 User s Manual VS Serena User s manual 5 Serena Reference 0202079 From version 2 04 4 0197 Manufacturer SAIME Z 1 25 rue de 77176 SAVIGNY LE TEMPLE FRANCE T l 33 0 1 64 19 11 11 Fax 33 0 1 64 41 81 30 33 0 1 64 41 80 31 NEAT0202079 K 3 31 User s Manual VS Serena NEAT0202079 K 4 3 User s Manual VS Serena WARNINGS This manual should be read and understood before using this device on a patient This User s Manual goes with a Service Manual NTA0208095 which should be read and understood by the technical staff in charge of the overhaul Professionally trained and competent personnel working under the doctor s responsibility may carry out the settings A medical doctor should decide the ventilation settings This device has been classified as fit for adult and paediatric ventilation This device must not be used for life support This device has been approved for a continuous service The device should not be restarted immediately if conditions of storage and or transport are different than the recommended operating conditions The device should not be used onto the mains without being removed
5. For reusable chambers cold decontamination by immersion is also possible Use 2 or 4 of BACTINYL instrumentation liquid soap solution or equivalent 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 9 5 6 Technical properties of BACTYNIL 5M BACTINYL S5SM is a concentrated disinfectant SPORICIDE FUNGICIDE BACTERICIDE amp VIRUCIDE BACTINYL G5M is used with clean materials which has been decontaminated beforehand with soapy water e Use Prepare an immersion bath at 2 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 parts Leave it in the water for 15 minutes Rinse with sterile water or water with low bacteria count Let dry ES e Caution Do not use with other products Do not swallow Rinse with clear water if the product is in contact with skin or eyes e Information For surface disinfecting SAIME recommends BACTINYL FUNGICIDE BACTERICIDE and VIRUCIDE The F GARCIN pharmaceutical laboratories manufacture BACTINYL 63000 CLERMONT FERRAND FRANCE Any equivalent chemical can be used WARNING Maintenance centres may use other decontamination procedures However they must be approved and respect current rules and regulations If other products are used they m
6. M L NEAT0202079 K 10 31 User s Manual VS Serena The VS bi level can also be connected with a humidifier Fisher amp Paykel type 150 or equivalent NEAT0202079 K 11 31 User s Manual VS Serena Contents L Description and Assembling 14 Tod and held or applicat OT un eR 14 1 2 ea TAS EN E 14 1 3 rcu CONNEC ON sn tt LESE iM DOM NNI MI Mi EP Coi MA Eo pM 14 ARCO TGV OU te te itea temi 15 Be 16 20 E 16 22 Control of the functioning and conditioning for a new 16 M 17 1 1 18 3 1 lys P Em 18 2 2 PLOT 18 4 19 4 1 TENCO MR rn 19 4 2 EU iot ME M 19 ID ILLE 20 5 1 H 20 2 2 OY etapas
7. Transport temperature from 10 C to 60 C Note in case of default of one of those following variations the device works Temperature from 5 to 40 C Relative humidity from 10 to 95 RH Atmospheric pressure from 700 mb to 1060 mb Mains tension from 15 to 10 nominal External supply from 26 1590 to 25 10 6 Applied standards The device meets with the following standards e EN 60 601 1 For electromedical devices safety rules EC 601 1 4 For electromedical devices programmable systems e EN 60 601 1 2 Compatibilit lectromagn tique pour les appareils lectrom dicaux EN 55 011 55 EN 61 000 4 2 EN 61 000 4 3 EN 61 000 4 4 EN 61 000 4 5 EN 61 000 4 6 EN 61 000 4 8 EN 61 000 4 11 CEI 801 3 EN 61000 3 2 EN 61000 3 3 NEAT0202079 K 29 31 User s Manual VS Serena EN 17510 EN 1441 EN 1281 1 EN 980 UTC C74 003 EN 739 EC 0197 93 42 EEC WEEE 2002 96 EC European Directive concerning the proper disposal of electrical and electronic equipment 0197 directive 93 42 notified body T V Rheinland 10 7 Accessories technical specifications Tendances is a software dedicated to the recording of the principal ventilatory parameters This trend analysis software allows analysing the data of both patient and device stored in the Bi level ventilator during several months of using It gives access to the following
8. c min gt Pressure Unit hectopascal hPa Readings accuracy 1 1 hPa Measure accuracy bargraph 2 hPa gt The precision depends on the used mask The tidal volume measures correspond to ATPD conditions no humidity in the air Accuracy 2 of the full scale 4 of the readings EN 17510 NEAT0202079 K 23 31 User s Manual VS Serena 8 The Alarms 8 1 Definitions When an alarm is activated a message flashes on the screen and a buzzer rings out 8 1 1 The automatic alarms Continuous Buzzer Alarm No supply connected The device stops d Mains No more mains supply with at least an other supply connected Check the mains supply connection 24 Disconnection High flow and pressure almost zero Check the patient circuit Note In S mode this alarm is inactive if the automatic starting is selected Yes 8 1 2 The technical alarms Jum Global technical alarm ra or Stopped turbine Low tension of the back up battery Connect onto the mains Check date and hour gt Procedure of alarms checking Mains No more mains supply Disconnect the mains cord with an other external alimentation connected Disconnection disconnect the patient circuit 8 2 Alarms Priorities The alarms priorities are represented by the flashing red led on the button by buzzer 8 2 1 High Priority This priority is represented by a quick flashing led and a buzze
9. IAL ULTRA MIRAGE MEDIUM STD 60613 MASQUE FACIAL ULTRA MIRAGE MEDIUM SHALLOW 60614 MASQUE FACIAL ULTRA MIRAGE LARGE STD 60615 MASQUE FACIAL ULTRA MIRAGE LARGE SHALLOW CAUTION KIT MASQUE MIRAGE SWIFT TAILLES S M L RESMED reference 60506 must not be used with version 2 04 1 or equivalent NEAT0202079 K 9 31 User s Manual VS Serena With software version 2 03 and former versions we recommend the following masks when using an open circuit ventilation i e leakage 16518 KIT MASQUE MIRAGE STANDARD for PPC 16519 KIT MASQUE MIRAGE LARGE for PPC 16545 KIT MASQUE ULTRA MIRAGE PPC STANDARD 16546 KIT MASQUE ULTRA MIRAGE PPC LARGE 16578 ULTRA MIRAGE MASK SHALLOW WIDE CE 60003 ENSEMBLE MASQUE MIRAGE VISTA STANDARD 60004 ENSEMBLE MASQUE MIRAGE VISTA PROFOND 60103 MASQUE MIRAGE ACTIVA STANDARD 60104 MASQUE MIRAGE ACTIVA LARGE 60105 MASQUE MIRAGE ACTIVA SHALLOW 60011 MASQUE MIRAGE KIDSTA SML 632003 KIT COMPLET MASK PAPILLON TAILLE 1 632004 KIT COMPLET MASK PAPILLON TAILLE 2 LARGE CAUTION The following masks must not be used with version 2 03 and former versions 60610 60611 60612 60613 60614 60615 60506 2 or equivalent MASQUE FACIAL ULTRA MIRAGE PETIT STD MASQUE FACIAL ULTRA MIRAGE PETIT SHALLOW MASQUE FACIAL ULTRA MIRAGE MEDIUM STD MASQUE FACIAL ULTRA MIRAGE MEDIUM SHALLOW MASQUE FACIAL ULTRA MIRAGE LARGE STD MASQUE FACIAL ULTRA MIRAGE LARGE SHALLOW KIT MASQUE MIRAGE SWIFT TAILLES S
10. L min 180 L min 168 L min Deliverable maximum minute volume In the optimal adjustment conditions IPAP 30 EPAP 4 various frequency and for the following physiological characteristics Rp 20 C 0 05 V 20 L min Rp 5 C 0 05 V 35 L min Inspiratory resistance Flow 60L min R 4 7 hPa tube resistance Expiratory resistance Flow 60L min R 4 3 hPa tube resistance Used materials in direct contact with patient gaz ABS Aluminium Silicon Stainless steel Polyester Brass Chrome NEAT0202079 K 28 31 User s Manual VS Serena 10 5 Use storage and transport conditions gt Current use Operating temperature from 5 C to 40 C Relative humidity from 30 to 75 90 Pressure from 700 to 1060 hPa gt Storage Device with its accessories in original boxes Storage temperature from 10 C to 50 C Relative humidity from 10 to 90 Do not store in humid conditions The device is fragile it should be stored as it 1s used Device with its accessories not in original boxes Storage temperature from 10 C 50 C Relative humidity from 10 to 90 Do not store in humid conditions The device 15 fragile it should be stored as it 1s used gt Transport Transport temperature from 10 C 50 C Relative humidity from 10 to 90 The ventilator and its accessories should be placed in their original SAIME packaging for transport Warnings Fragile device sensible to humidity respect the transport position
11. Power supply 230 100 VAC 50 60 Hz 52 VA and or external supply 26 VDC maxi medical EN 60601 1 The specific cable delivered with the device should supply the appliance current using another model could be dangerous for the patient The device and its user s manual have obtained the CE marking Rheinland Every used accessory should be CE too The re inhalation of the carbon dioxide is limited by the leaks at the mask and the cleaning of the circuit by the constant flow circulation The serial number of the device gives the product code the manufacturing year and month the number of the device in the month In case of a technical alarm switch off the device plug it from the mains and from O2 supply NEAT0202079 K 6 31 User s Manual VS Serena This device should be disposed of separately not as unsorted waste To dispose of your device you should use appropriate collection reuse and recycling systems available in your region The use of these collection reuse and recycling systems is designed to reduce pressure on natural resources and prevent hazardous substances from damaging the environment This directive applies to all devices manufactured after august 2005 and with serial numbers bigger than VSO508001 VS 02 07 003 number in the month year 1 to month Example NEAT0202079 K 7 31 User s Manual VS Serena Packing list DESIGNATION Kit Accessories KITO12892 Mains
12. ar after 10 s NEAT0202079 K 16 31 User s Manual VS Serena 2 3 Stop Stop press two seconds on the i button the ventilation stops and the device is in stand by mode button Disconnection of the mains cord a continuous buzzer rings out to confirm press on the X Note the patient can automatically starts the device when the Awto function is activated Yes In the S and CPAP modes the Bi level is automatically in stand by mode if the patient stops ventilation himself putting out the mask To connect onto the mains does not inhibit the continuous alarm you have to deactivate it by pressing the Silence Alarm button NEAT0202079 K 17 31 User s Manual VS Serena 3 Supplies 3 1 Types b symbol displays behind the used supply AC Mains External supply Note only the connected supplies are shown at the top right of the screen CAUTION This device includes a safe battery We strongly recommend before any use to connect the device to the mains power for 24h in order to ensure the optimum charge of the batteries In a general way for an optimum use a minimum time of charge of 24h is necessary after storage for more than 4 weeks 3 2 Priority The mains has always priority over the other supplies NEAT0202079 K 18 31 User s Manual VS Serena 4 Access without unlocking 4 1 The measures The pressure is indicated on the bargraph 1 block hPa TE Two measures displ
13. ation on the place of use For any new patient the process is as indicated Element Interval New patient Frequency given by Frequency given constructor by staff Patient circuits Yes Heating chamber M Ye Ya 9 5 2 Patient Circuit Reusable patient circuit elements should be disinfected and cleaned as per the manufacturer s recommendations The reusable patient circuit should be regularly cleaned with soapy water rinsed with clear water and dried before re use This basic maintenance procedure is recommended for home ventilation on one single patient Cold disinfecting by immersion is also possible Use the BACTINYL 5M solution or equivalent 9 5 3 Bacteria filter Bacteria filters situated in the inspiratory circuit and used for bacterial and viral filtering should be replaced in accordance with manufacturer s instructions and for each new patient NEAT0202079 K 25 31 User s Manual VS Serena 9 5 4 External units parts The external parts of the ventilator can be cleaned with a dry cloth or if necessary a slightly wet sponge Do not use abrasive powders alcohol or solvents 9 5 5 Heating chamber humidifier We recommend the use of disposable chambers Disposable heating chambers should not be put into an autoclave They should not be used with solutions containing phenol ketene formaldehyde hypochloride chlorinated hydrocarbons aromatic hydrocarbons and organic acids
14. ay on the screen by pressing on the button they disappear after 10s During this display press on the F gt and buttons to accede to the IPAP EPAP and f min parameters The measures are estimated patient tidal volume f patient frequency Note The measures are also accessible when the device is unlocked 4 2 The slope It is the rising time between the expiratory and inspiratory pressure To select this parameter press on the 4 button until the slope symbol appears Adjust with the F and buttons The adjustment values are 9 NEAT0202079 K 19 31 User s Manual VS Serena 5 Setting access 5 1 Unlocking It allows to accede to the following parameters The ventilation mode if f min 25 c min the ST mode is activated if f min lt 5 c min the S mode is activated The inspiratory and expiratory pressure IPAP EPAP The inspiratory time Ti min Ti max not in CPAP mode The minimum frequency f min The trigger Trig Automatic starting Auto D The measures The slope The ramp only in CPAP mode To accede to this menu press on the button until the audible bip The a symbol appears on the screen The device is unlocked Note to lock the device press again on the ES button until the padlock disappears If no button is activated for two minutes the device is automatically locked 5 2 Selecting To se
15. d CPAP modes and when the device is locked 7 2 Parameters chart depending on the ventilation modes Parameters Timin seconds 03325 03925 03925 pe ee rix Sp wmn onra inia ____ No 545 in CPAP and S mode the Trig parameter does not appear the trigger is automatic Ti min and Ti max depend on the frequency adjusted Note The IPAPmax pressure is limited to 30 hPa The IPAPmin is limited in S mode gt IPAP gt EPAP 1 hPa in ST mode gt IPAP gt EPAP 2hPa NEAT0202079 K 22 31 User s Manual VS Serena 7 3 Units and accuracy Adjustable Parameters 2 Inspiration IPAP Unit hectopascal hPa Readings accuracy 1 hPa Setting accuracy 2 hPa gt Expiration EPAP Unit hectopascal hPa Readings accuracy 1 hPa Setting accuracy 2 hPa gt Minimum Frequency f min Unit cycles minute c min Readings accuracy c min Setting accuracy period 10 ms gt Minimum inspiratory time Ti min Unit seconds s Readings accuracy 0 1 s Setting accuracy 10 ms Maximum inspiratory time Ti max Unit seconds s Readings accuracy 0 1 s Setting accuracy 10 ms Measures Estimated Tidal Volume Tv Unit litre L Readings accuracy 0 01 L Measure accuracy estimation Frequency f Unit cycles minute c min Readings accuracy 1 c min Measure accuracy
16. dversely affect the ventilator This device should not be used with patient circuits made with current conducting material No device sterile under non watertight film wrapping Do not expose the ventilator to direct sunlight This device is fragile Do not handle it roughly 8 AC mains supply must be in conformity with local regulation The ventilator should be run from its external DC supply in case of serious mains supply disturbances 8 n case of a prolonged storage without being connected onto the mains the back up battery naturally runs down When starting the device if the back up battery alarm releases connect the device onto the mains for several hours Make sure that the total resistance of the patient circuit and ventilation accessories does not exceed 6 hPa at 60 litres minute for adults and 6 hPa at 30 litres minute for children 9 All faulty fuses on the supply board should be replaced with identical fuses respecting identical standards The primary fuse on the mains socket protects the transformer from overload Before every use on a new patient and when using the device for the first time the ventilator must be cleaned and disinfected according to the procedure see chapter Maintenance and Disinfection ventilator should be disinfected and decontaminated as per the manufacturer s indications and the procedure s set down by the hospital or the home ventilation care organisation
17. flation towards patient Note Check the settings and alarms adjustment before connecting on the patient The insufflation connector has a standard size 22 mm NEAT0202079 K 14 31 User s Manual VS Serena 1 4 Rear lay out Serial line External supply Mains Tension selector 100 230VAC Fuse drawer Note the safety hook near the mains connection protects the device against the accidental disconnection of the mains It should be put on the mains cord after the connection see picture below Gas inlet IAN Caution connectors of the rear panel are not protected against electrostatic discharges Note make sure that the ventilator s inlets are not blocked up Note when the switch is commutated on 220 the device can function on 230 VAC When the switch is in position 100 the device can function on 100V or 120V according to the checked box NEAT0202079 K 15 31 User s Manual VS Serena 2 Start Stop 2 1 Start Mains cord connection the device is in stand by mode The following screen appears with mains symbol date hour version Date and hour settings In stand by mode press the Menu button until the date flashing Adjust date and hour with and buttons then confirm by pressing the Menu button until the date and hour stop flashing Starting Press on the Coe button a buzzer rings out the device starts on Note when the device is turned on two counters of hours are disp
18. from its transport bag 8 SAIME 15 willing to provide further information on the steps taken to guarantee the cleanliness of the respirator elements during the production and delivery phases The device should be used only in its normal operating position placed firmly on its feet 8 Use the unit s carry handle for the transport and handling Do not use the device carry handle if a patient is being ventilated on the machine Do not block up the ventilator s inlets The device must not be covered or placed in such a way as to adversely affect ventilation The complete patient circuit should be thoroughly checked for leaks or defects before connecting the patient The pressure in the ventilator is greater than the atmospheric pressure at all times during the exhale cycle device and the turbine conception have been designed in such a way as to limit the output pressure to a maximum of 39 hPa The alarms should be checked regularly especially before the ventilator is used on the patient and when used for on going home ventilation This device should not be used with inflammable anaesthetic agents s The ventilator may dysfunction if used in the presence of devices that generate short wavelengths or high frequencies defibrillators diathermia devices electro surgical devices X ray devices cellular phones etc NEAT0202079 K 5 31 User s Manual VS Serena Electromagnetic fields exceeding 10 V m may a
19. layed and also the country of use e Patient 00000h e Device To reset the patient counter press simultaneously and 4 9 while it appears Warning this resets trends memory While the above counters are displayed press one second on the Menu button in order to display the Meca parameter turbine overhaul instead of the Device counter e Meca 00000 refer to the Service Manual NTA0208095 To set the device with the manufacturing parameters while the Meca counter displays after the device turns press simultaneously 49 and Warning this resets the trends memory and the Patient counter 2 2 Control of the functioning and conditioning for a new patient Before every use on a new patient and when using the device for the first time the ventilator must be cleaned and disinfected according to the procedure see chapter Maintenance and Disinfection To check the functioning of the device Assembly the patient circuit with a balloon a SIEMENS for example and then start the device Check the pressure on the bargraph the measures and the alarms triggering see Procedure of alarms checking chapter 8 Check also the similarity between the settings and the measures made by the device see Units and accuracy chapter 7 Pressing one second on the button Ca and check the display of the measured frequency and the delivered tidal volume The screens disappe
20. lect a parameter scroll with the button until the requested parameter appears If you press the button while you maintain pressed the button you could go back in the Menu 5 3Adjusting Once the selected parameter adjust the value with the D button to increase the button to decrease NEAT0202079 K 20 31 User s Manual VS Serena 6 Ventilation Modes 6 1 The S mode spontaneous mode f min NO This mode is a two pressure levels ventilation The frequency and the inspiratory time are entirely patient triggered The adjustable parameters are The inspiratory pressure IPAP The expiratory pressure EPAP The minimum frequency f min No The minimum inspiratory time Ti min The maximum inspiratory time Ti max Automatic starting The slope Note in the case IPAP EPAP the CPAP mode appears the slope symbol and f min disappear Then can adjust the ramp 6 2 The ST mode spontaneous mode with minimum frequency f min 5 c min In addition to the S mode characteristics this mode allows to adjust a security frequency f min The adjustable parameters are The inspiratory pressure IPAP The expiratory pressure EPAP The minimum frequency f min The minimum inspiratory time Ti min The maximum inspiratory time Ti max The trigger Trig Yes Automatic starting The slope 6 3 The T s mode timed mode with frequency The adjustable paramete
21. parameters and graphics Parameters e Tv estimated tidal volume delivered by the device frequency of respiratory cycles measured by the device Leaks estimated leaks in comparison with the leaks of the mask e Vol minute calculated volume minute on the basis of the estimated Tv and the measured frequency 2 Graphic analysis e 4 trends with dating of beginning and end of a session length of session e Ventilation log histogram of lengths it includes the whole sessions of ventilation stored as histograms day by day Dji ie IPIS w Note in case of sudden stop of the device further to a mains cut the last quarter of hour of the ventilation trends is not saved and cannot be recovered NEAT0202079 K 30 31 User s Manual 11 Symbols Type BF device DC voltage Store and transport this side up On Off button Recycling NEAT0202079 K Oo Classe II device ONS AC voltage v 1 Fragile Beware of Electrostatic discharges VS Serena Please read the supplied documentation 4 0197 CE label ill Keep away from humidity Insufflation towards patient 31 31
22. r ringing out every 8 seconds eee ee or a continuous buzzer ringing out in case of defect stop of the device 8 2 2 Medium Priority This priority is represented by a moderate flashing led a buzzer ringing every 20 seconds 8 2 3 Low Priority This priority is represented by a continuous led a discontinuous buzzer every 5 seconds For any further persistent alarm or in case of any doubt please contact your technician NEAT0202079 K 24 31 User s Manual VS Serena 9 Maintenance and disinfection 9 1 Fuses replacement Time lagged fuse cutting high power T 630mA 250V for a use on to the 230 VAC mains T 1 25A 250V for a use on to 100 VAC mains 9 2 Dust Filter replacement Before every use on a new patient check the dust filter which is on the rear face Note we recommend to replace this filter for each use on a new patient 9 3 Replacement of the internal filter The air filter placed into the turbine compartment has to be replaced by a qualified technician Note we recommend to replace the internal filter yearly 9 4 Check the calibration Check the calibration of the pressure measurement between each patient or and yearly cf the procedure in the service manual 0208095 9 5 Cleaning Sterilising 9 5 1 Frequency The disposable ventilator elements should be cleaned or replaced in accordance with either the manufacturer s instructions or the medical policy in oper
23. rs are The inspiratory pressure IPAP The expiratory pressure EPAP The frequency f The minimum inspiratory time Ti min The maximum inspiratory time Ti max The trigger Trig No Automatic starting The slope NEAT0202079 K 21 31 User s Manual VS Serena 7 The parameters 7 1 Definition IPAP Inspiratory Positive Airway Pressure inspiratory pressure delivered by the device It cannot be less than the expiratory pressure 2 hPa except in CPAP and S modes EPAP Expiratory Positive Airway Pressure expiratory pressure delivered by the device The frequency f minimal number of cycles per minute delivered by the device to the patient in ST mode f min lt 5 c min f min No gt 5 mode In T s mode f min is replaced by f The inspiratory time Ti inspiratory phase of each cycle It can be adjusted as a minimum Ti min this parameter has always priority over Ti max a maximum Ti max Note Ti max Ti min 0 5 s The trigger allows the patient to release himself inspiration cycles This function is adjusted from the ST mode Trig Yes to the T s mode Trig No The automatic starting Awuxo amp D This function can be activated or not Yes No It allows the patient to be able to start the device when he wants by breathing through the mask Note moreover it allows the device to be automatically in stand by mode after 30 s if the patient put out his mask only in S an
24. ust 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 Note due to the device conception in leakage ventilation the contamination by the expired gas of the patient is highly limited to the pneumatic circuit Indeed at the time of the active expiration of the patient when the cycle begins there is a column of clean air between the device and the patient volume of the patient circuit During the passive phase of the expiratory cycle a constant flow allows the expired gas to be evacuated by the leaks of the mask cleaning Nevertheless using a bateria filter is the only precaution which assures an optimal protection particularly in hospital So we recommend the change of the patient circuit for each new patient The pneumatic elements and the internal foams are not submitted to the same conditions NEAT0202079 K 26 3 1 VS Serena User s Manual 10 Technical Characteristics 10 1 Synoptic Battery Watchdog Saveguard S 232 line Buzzer Blower Speed Driver uP Voltage Selector R External RS232 Supply connector inlet Transformer Display Keyboard Selector 100 230V O 2 o 27 sensor Rotative Rotative Valve motor o 3 2 A 9 Rotative valve Po
25. wer supply Distribution EMIFilter CPU BOARD 1 1 a A M i Pressure AC Mains C Fuses connector r inlet Electric line Insufflation Pneumatic line port 27 31 NEAT0202079 K User s Manual VS Serena 10 2 Functioning The gas source is driven by an internal blower the external air is inhaled through a dust filter The positive inspiratory and expiratory pressures are driven at the settings with a pneumatic distributor During the insufflation a rotating valve drives the air of the blower towards the patient At the expiration it drives the expired gas through the exhalation outlet Thus it reduces the concentration of re inhaled CO during the next cycle Inspiratory and Expiratory triggers are based on inspiratory Pressure signal analysis pressure settings and closed loop blower signal 10 3 Power supply Class II type BF device Mains 230 100 50 60 Hz 52 VA Imax 630 mA External supply 26 VDC 10 maximum CE medical EN60601 1 10 4 Specifications Sound level 29 dBA measured under ISO3744 amp 7510 standard Weight 2 5 kg Dimensions 135 mm x 285 mm x 204 mm Compliance no measurable Maximum adjusted pressure 30 hPa Maximum pressure in 1 fault condition 39 hPa Flow at 10 20 30 hPa 204
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