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Summary of Contents for Stephan Alia
- Page 1 Alia Ventilator Alia EXPIRATIONS-DRU CK INSPIRATIONS-DRU CK PLATEAU PEEP mbar Steriles aqua dest. max. M ed. A IR Service Instructions...
- Page 2 The device is only intended Note for the described purpose. F. Stephan GmbH - Medizintechnik - Kirchstrasse 19 56412 Gackenbach Subject to technical alterations. as of: Januar 2006 version: V1.0 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 3: Table Of Contents
3.6.1 Patient tube system for adults........40 3.6.2 Patient tube system for children ........42 3.6.3 Temperature sensor for patient tube system....43 3.6.4 Pneumotachograph type D ........44 3.6.5 Pneumotachograph Typ C .........44 Serial interface .................45 Commands ................46 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 4 6.3.1 ½ yearly maintenance basic unit .......55 6.3.2 Maintenance of the patient part .........59 Safety checks .................60 6.4.1 Test report ..............61 Troubleshooting ................69 Annex....................71 List of illustrations ................73 List of tables..................75 Place for your Notes.................77 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 5: General Information
Safety checks must be carried out every six months. Maintenance must be carried out by the authorized customer service of F. STEPHAN GMBH. Only spare parts from F. STEPHAN GMBH must be used during maintenance. Clean and disinfect the device respectively device parts every time before maintenance, even when returning the device for repairs. -
Page 6: Abbreviations And Definitions
= mbar Inspired oxygen concentration Incremental transducer Push button and knob Power distribution unit Power Distribution Unit PEEP Positive end expiratory pressure Volt Unit of measurement for electrical voltage Table 1: Abbreviations and definitions © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 7: Safety Instructions
Refers to warnings which, if not heeded, can result in malfunctions, damage or defects in the device, which can possibly also put the patient at danger. Warning Refers to precautions which, if not heeded, can result in damage to the device and its accessories. Caution © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 9: Mechanical Structure
M4x10. The 9 screws used on the side of the device are also fitted with rosettes to prevent damage to the plastic front housing when tightening the screws. Fig. 1: Opening the housing The front housing can now be hinged open to the front. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 10 This input periphery consists of touch buttons, the IGR (push/turn knob), the LCD display, the controller board, the double flowmeter ON/OFF switch on the front pane. Fig. 3: Front housing with input periphery 1 double flow meter 2 FiO and flow adjustment © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 11 The oxygen sensor is located on the left next to the intake filter. It is screwed into the connection block. It can be removed by turning counter-clockwise. The electrical connection between the oxygen sensor and device consists of a 2-pin AMP connector. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 12 On the left and right side wall there are recessed handles for carrying the ventilator. Some of the electronic controls and the power supply are accommodated inside the ventilator. Fig. 6: Electronic components 1 Power supply 3 Electronic controls 2 Cold device connector combination © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 13 1 compressor 2 fresh gas reservoir 3 gas inlets 4 service flap The patient part is connected to the basic device from the front. The patient part is held in position by the guide rail. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 14 Mechanical structure Fig. 8: Inserting the patient part © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 15: Components And Functions
® Components and functions Components and functions The A ventilator consists primarily of the following parts: Electronic controls Power supply Gas supply Fresh gas reservoir Patient part Patient tube system Fig. 9: A block diagram © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 16: Electronic Controls
An SPI bus system provides the link to the micro controller. This simplifies linking the various components in terms of both hardware and software. The following illustration shows the components on the sensor board. Abb. 2: Sensor board © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 17 The differential pressure developing over the resistance body of the PNT head is used for measurement of the volume flow. This differential pressure is conveyed via two tubes to the differential pressure sensor. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 18 V6. During this procedure, the display shows "CAL" in the window of the FiO value. After completing calibration, the valve switches the oxygen sensor back to the output of the double flowmeter. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 19 ® Components and functions Fig. 11: Display showing 'CAL' Fig. 12: Pneumatic function diagram © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 20: Controller Board
The controller board also contains the alarm system for indicating alarm statuses. The digital interfaces for triggering the actuators and reading the sensors (via the sensor board) are integrated on the controller board. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 21 (graphical user interface). The signals of the capacitive sensor button on the front panel and of the incremental transducer (IGR) are read and processed by processor M68HC11. In addition, the graphic output is generated on the LCD. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 22: Power Distribution Unit Pdu
(power failure, voltage fluctuations, etc.) then the ventilator runs off the battery. This happens without electronic changeover (parallel mode). The Power Distribution Unit PDU can only be switched on by a switched on by a rechargeable battery. This can also be discharged (≥ 10.8 V). © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 23 The charge status of the battery is shown by three coloured LEDs (red, orange and green). The charge curve is taken into consideration. The charge status can be read off the LEDS: = 10-40 % orange = 40-90 % green = 90-100 % © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 24 <10.8V ( Batt_enable = 0). An acoustic and visual alarm battery is given. The user should stop using the ventilator and recharge the battery, or provide another voltage source. Compressor ON/OFF The compressor is switched on/off without any contact. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 25: Power Supply
The rechargeable battery provides a backup power supply in the event of a mains power failure. The Power Distribution Unit controls the changeover to the provided voltage source. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 26: Power Supply Unit
100 – 240 V AC, 2 A, 50/60 Hz Fuse: Output voltage: 15 V DC, 185 W Fuse: 16 A The output voltage of 15V DC and the DC_good signal are conveyed directly to the Power Distribution Unit PDU. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 27: Rechargeable Battery
Gel-type lead battery Weight: 6.2 kg Rated voltage: 12 V Rated capacity: 17 Ah Fuse: 10 A Recharging time: 18 h Operating time: approx. 1 h with heating approx. 3.5 h without heating Connections: threaded hole M5 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 28: Inverter
The power supply is switched directly from the Power Distribution Unit PDU (compressor ON/OFF). Fig. 20: Inverter 1 inverter Input voltage : 15V/DC Output voltage: 230V/AC, 50 Hz stabilized Continuous power: 100 W The inverter has thermal overload protection and electronic short-circuit protection. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 29: Gas Supply
The output pressure is 300 mbar. The external gas supply is provided by the coded "NIST" resp. "DIN" gas inputs for O and AIR. The gases must be dry and free of oil and dust. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 30: Oxygen Supply
The corresponding pressure switch is queried by the sensor board. If there is no pressure ( <1 bar ), the display shows the question "Is O2 available?". Confirmation with "NO" deactivates the oxygen failure alarm! Fig. 23: Display O2 available © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 31: Compressed Air Supply
1 compressor The compressor is a maintenance-free magnetic piston pump. The compressor runs on mains voltage. The operating voltage for the compressor is generated by the inverter. This guarantees operation even without the mains power supply. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 32: Fresh Gas Reservoir
The tension springs in the bellows define the compliance of the system. The springs consist of stainless steel. Fig. 25: Fresh gas reservoir 1 bellow 3 container 2 spring © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 33 Filling and emptying the bellows is controlled by solenoids on the valve block, depending on the set ventilation parameters. Fig. 26: Valve block 1 valve block © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 34 Solenoid V1 remains open permanently. There is a constant flow of fresh gas to the patient part. Fig. 28: Gas flow in open mode In the semi-open mode (constant volume), solenoid V2 remains open permanently. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 35 The safety valve in the rear wall of the basic housing prevents any overpressure from accumulating in the bellows. The safety valve opens at a pressure of 70 mbar. Fig. 30: Safety valve 1 safety valve © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 36: Patient Part
The patient part contains the pneumatic components of the patient circuit. The plateau valve limits the maximum pressure and the PEEP valve adjusts the final expiration pressure. The heating and the water bath condition the breathing gas. Fig. 31: Patient part 1 patient part © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 37: Peep Valve
The PEEP valve is open in idle state. The extent of the final expiration pressure is defined by the tension of the spring before the valve plate. The tension in the spring is adjusted by the PEEP knob. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 38: Plateau Valve
Heating and moistening the breathing gas is coordinated by the sensor board. A temperature sensor in the inspiration fitting and at the end of the heating section of the inspiration tube provide the actual temperature value. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 39 4 heating cartridge The sensor board switches the 12V/35W heating cartridge and the tube heating on or off depending on the nominal and actual temperature value. The electrical resistance of the heating cartridge is 27.5 Ω. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 40: Patient Tube System
It must be connected to the red tube fitting on the patient part. The neutral coloured expiration tube is connected to the neutral coloured tube fitting. The continuously heated tube is 1100 mm long. The electrical resistance of the tube heating is 26 Ω. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 41 The connectors for the heating are plugged into the corresponding sockets on the ventilator. Fig. 36: Heating connection To measure the inspired or expired flow, a pneumotachograph type D make F. S H must be used together with a patient tube TEPHAN system for adults. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 42: Patient Tube System For Children
The connectors for the heating are plugged into the corresponding sockets on the ventilator. To measure the inspired or expired flow, a pneumotachograph type C make F. S H must be used together with a patient tube TEPHAN system for children. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 43: Temperature Sensor For Patient Tube System
Please comply with chapter 8 of the A operating instructions! A specially screened cable with a 5-pin "LEMOSA" plug connects the temperature sensor to the ventilator. This plug also connects the temperature sensor of the breathing gas humidifier to the ventilator. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 44: Pneumotachograph Type D
Fig. 39: PNT D 3.6.5 Pneumotachograph Typ C The pneumotachograph type C measures the inspired and expired flow (> 25 l/min) and is used together with a patient tube system for children. Fig. 40: PNT C © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 45: Serial Interface
Stop bits: Flow control: none After the ventilator has been switched on, the interface sends the following initialization sequence: Fig. 41: Initialization sequence During this phase, the controller runs through the stipulated algorithms for the self-test. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 46: Commands
Input of "cpr5" –ENTER starts 50 mbar calibration of the redundant pressure sensor: cpr5 Start calibration FlowCal=0 PO2Cal=0 PPatCal=0 PRedCal=35 Input of "cpp5" –ENTER starts 50 mbar calibration of the pressure sensor cpp5 near the patient: © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 47: Setting And Querying The Date And Time
15:17:30 10.12.05 The system is set to 10 December 2005, 15.17 hrs and 30 seconds. The clock in the A ventilator is not buffered! It serves merely for time recording when saving interface outputs. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 48: Output Of Measured Values
= Digital value of the redundant patient pressure sensor = Monitoring the oxygen pressure switch = Measuring the valve flows UeVD = Measuring the power supply of the pressure sensors TRed = Digital value of the redundant temperature sensor © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 49 The individual valves and switches are listed in the register shown below: EV1 EV2 = Expiration valve = Calibration valve of the oxygen sensor = Calibration valve of the offset value of the differential pressure = Battery switched on = Tube heating ON/OFF © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 50 Differential pressure in 1/10 µbar The displayed flow value results from the dP value calculated by means of the differential pressure value FlowIn(ExtADC). Temperature Temp_Pat= 148 In= 993 R= 7944 InRed= 255 RRed=32640 TempTank= 303 In= 997 R= 3988 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 51: Tools And Aids
Test lung for children Test lung for adults Hot air fan Lubricants/ Super Lube (silicone-based) auxiliary substances Berolube (oxygen-resistant grease) Loctite (anaerobic adhesive) Teflon sealing tape Soldering tin Unsoldering cord Silicone adhesive E41 and E43 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 52 Electronic pressure meter -10 – 100 mbar / tol. ±1 digit Instruments and accessories Oxygen monitor Pressure measuring set consisting of injection syringe, silicone tube 3x1.5, Y-piece (small), 3-way cock Safety tester as per VDE 0751 Vernier calliper Measuring tape © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 53: Checks And Maintenance
40 cmH ⇒ Inspiration pressure Close Y-piece Monitoring Pmax shows adjusted (plateau) inspiration pressure ⇒ Expiration pressure Monitoring PEEP shows adjusted (PEEP) expiration pressure ⇒ After 30 s, "Apnea" alarm Apnea monitoring Adjust respiration form C/BKUP © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 54: Weekly
The intake filter is at the back of the device. Open the service flap to remove and replace the intake filter. Fig. 43: Back of the A : service flap open 1 oxygen sensor 2 intake filter © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 55: Yearly
6 months. It must be replaced at the latest every 3 years. To remove the rechargeable battery, open the flap on the bottom of the ventilator. Fig. 44: Battery flap on the bottom of the A © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 56 3% from the actually achieved pressure values. Unscrew the left recessed handle to give access to the calibration block without opening the front housing. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 57 To do so, remove the silicone tube from the 4 mm fitting of the calibration block. Input of "cpr0" –ENTER starts offset calibration of the redundant pressure sensor: cpr0 Start calibration FlowCal=0 PO2Cal=0 PPatCal=0 PRedCal=30 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 58 Connect the opens to a pressure source and the water column and adjust to 50 mbar. Input of "cpr5" –ENTER starts 50 mbar calibration of the redundant pressure sensor: Cpr5 Start calibration FlowCal=0 PO2Cal=0 PPatCal=0 PRedCal=35 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 59: Maintenance Of The Patient Part
We draw attention particularly to the need for intensive cleaning of the inner part, the coil body and the magnetic core. In the case of pronounced wear (mechanical drive), replace the PEEP valve plate with axis and coil core. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 60: Safety Checks
Safety checks Safety checks must be carried out every six months by F. S TEPHAN H or the authorized customer service following the six-monthly maintenance. © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 61: Test Report
System type: Ventilator Manufacturer: F. Stephan GmbH Serial number: Software version: Serial number patient part: PNT: PNT C PNT D Tube system Children Adults Test equipment make: Type: Serial number: Remarks Tester: Test date: Signature: © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 62 Substitute system leakage < 1.0 current System leakage current (mains < 0,1 connector turned) Function test Sensor calibration (interface) (only if calibration was carried out !) Red. sensor Offset Gain Pat. sensor Offset Gain Flow sensor Offset © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 63 Alarm "O2 pressure low" Apply O pressure of 0.9 bar (increase slowly) Reset alarm "O2 pressure low" Connect O supply: Is O2 available? No alarm "O2 pressure low" Is O2 available? No alarm "O2 pressure low" © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 64 Insp = 2 s Exp = 31 s Alarm CMV SIMV A/CV C/BKUP ASB N/CPAP PEAK PRESS STENOSIS PRESS/DISCON LOW MIN. VOLUME High MIN. VOLUME VT (EXP) LOW APNOE no alarm Alarm sound HP Alarm sound MP © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 65 Remove temperature sensors T. SENSOR FAIL HUM T. SENSOR FAIL PAT H1 = 0, H2 = 0 Tube heating Tube heating HEATING H2 FAIL Patient part HEATING H1 FAIL Voltage: FiO2<18% LOW FiO2 HIGH FiO2 CALIBRATION O2 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 66 1 – 3 mbar 4 – 6 mbar 9 – 11 mbar Pmax Results Criterion Results Pmax Unit measuring ± digit Alia unit 14 – 16 mbar 24 – 26 mbar 34 – 36 mbar © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
- Page 67 PNT D Results Criterion Results Unit measuring ± 20 % Alia unit 40 – 60 120 – 180 ml 240 – 360 ml 400 – 600 ml 1000 800 – 1200 1300 1040 – 1560 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 69: Troubleshooting
Sensor depleted CALIBRATION O Faulty calibration Calibrate sensor Replace sensor TEMP.SENSOR Measured temperature close to Check temperature sensor patient is outside the measurable Check sensor cable range Replace temperature sensor Table 3: Troubleshooting table © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 71: Annex
® Annex Annex Fig. 48: A complete modules 1 fresh gas reservoir 5 compressor 2 power supply 6 sensor and PDU board 3 valve block 7 rechargeable battery 4 patient part © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 72 Annex Fig. 49: Pneumatic diagram © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 73: List Of Illustrations
Fig. 24: Compressor ................31 Fig. 25: Fresh gas reservoir..............32 Fig. 26: Valve block................33 Fig. 27: Valve block................34 Fig. 28: Gas flow in open mode .............. 34 Fig. 29: Gas flow in semi-open mode ............. 35 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 74 Fig. 45: Tube fitting for pressure calibration .......... 57 Fig. 46: PC monitor after saving ............. 58 Fig. 47: Remove front panel of patient part ..........59 Fig. 48: A complete modules ............71 Fig. 49: Pneumatic diagram ..............72 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB...
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Page 75: List Of Tables
® List of tables List of tables Table 1: Abbreviations and definitions ............. 6 Table 2: Test list..................54 Table 3: Troubleshooting table ............... 69 © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... -
Page 77: Place For Your Notes
® Place for your Notes Place for your Notes © F. Stephan GmbH SA-112-0106V1.0-WEM-GB... - Page 78 F. Stephan GmbH - Medizintechnik - Kirchstrasse 19 56412 Gackenbach (+)49 (6439) 9125 – 0 (+)49 (6439) 9125 – 111 info@stephan-gmbh.com www.stephan-gmbh.com...
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