drager savina呼吸机维修手册（英文）.pdf

SavinaIntensivtherapie-VentilatorTechnical DocumentationCopyright by Drager Medical AG&Co.KGaA,Lubeck,Federal Republic of Germany Copying is prohibited for commercial purposes.Subject to change without notice.No replacement in case of changes.Attention is to be paid to the Instructions for Use/Operating Instructions.This technical documentation does not replace the Instructions for Use/Operating Instructions.The warranty and liability conditions of the general terms and conditions for business transactions of Drager Medical AG&Co.KGaA are not extended by this technical documentation.Safety Regulations:Reference is hereby made to the observance of the relevant safety provisions,such as the Medical Equipment Ordinance(Medizingerateverordnung),the Pressure Container Ordinance(Druckbehalterverordnung),the Technical Rules for Pressurised Gases(Technische Regeln Druckgase)or the Occupational Health and Safety Provisions(Unfallverhutungsvorschriften).Insofar as reference is made to laws,regulations or standards,these are based on the legal system of the Federal Republic of Germany.Follow your local laws and regulations.ContentsGeneral1 Symbols and Definitions5Function Description1 General 61.1 Working principle.61.2 Monitoring.62 Principal components 72.1 Electronics.82.2 Operator Control Panel.152.3 Pneumatic system.17Test List1 General232 Test equipment required for the Test ListpgCDsal26一A d o。.A-uo sn-EEOL1.LOZL.b L Ez。山006 寸 999XN 山3 General condition 243.1 Accessories(if fitted).244 Special accessories(if fitted)245 Accompanying documents check 256 Safety checks 256.1 Test of electrical safety to VDE 0751.255664.900 SavinaContents1Contents6.2 Test of electrical safety to IEC 60-601.267 Testing the safety features 277.1 Testing the pneumatic safety valve.277.2 Testing the emergency air valve.287.3 Testing the non-return valve in the expiratory valve.297.4 Testing the emergency expiratory valve.297.5 Testing the temperature measurement.308 Checking the readiness for operation according to Instructions forUse/Operating Instructions 309 Handover30Replacing Non-Repairable Items1General notes312Replacing the lead-gel battery(internal battery)323 Replacing the filter in the 02 inlet 36Schematics and DiagramspgCDsal26一A d o。.A-uo sn-EEOL1.LOZL.b L Ez。山006 寸 999XN 山1 Front view Savina 422 Rear view of Savina 443 Identification of PCBs 473.1 O2 Valve PCB.473.2 Control PCB.495664.900 SavinaContents2Contents3.3 Front Panel PCB.503.4 O2 DiaphragmPCB.524 Pneumatic diagram 535 Savina tubing diagram 54Changes1 List of Changes 56Annex1 Spare Items List 58pgCDsal26一A d o。.A-uo sn-EEOL1.LOZL.b L Ez。山006 寸 999XN 山5664.900 SavinaContents3GeneralThis Technical Documentation/Service Manual conforms to the International Standard IEC 60601-1.Read each step in every procedure thoroughly before beginning any test.Always use the proper tools and specified test equipment.If you deviate from the instructions and/or recommendations in this Technical Documentation/Service Manualthe equipment may operate improperly or unsafely,or the equipment could be damaged.Use only original Drager parts and supplies.The maintenance procedures described in this Technical Documentation may be performed by qualified service personnel only.These maintenance procedures do not replace inspections and servicing by Drager Medical AG&Co.KGaA.AStrictly follow the Instructions for Use/Operating Instructions!This Technical Documentation does not replace the Instructions for Use/Operating Instructions.Any use of the product requires full understanding and strict observation of the product-specific Instructions for Use/Operating Instructions.Unless otherwise stated,reference is made to laws,regulations or standards(as amended)applicable in the Federal Republic of Germany.pgCDsal26一A d o。.A-uo sn-EE-0LL OZLOOL E二 040。6 寸99gx5664.900 SavinaVersion 2.0General41Symbols and Definitions-A dash一)is used to identify items on a list.-A bullet()is used to identify a sentence that contains direct work instructions.AThis symbol is used to provide important information that,if ignored,could lead directly to a patienfs or operators injury.It is also used to provide important information that,if ignored,could lead directly to equipment damage and,indirectly,to a patienfs injury.This symbol is used to provide additional information,operating tips,or maintenance suggestions.Definitions according to German standard DIN 31051:Inspection=examination of actual conditionServicing=measures to maintain specified conditionRepair=measures to restore specified conditionMaintenance=inspection,servicing,and repairOZLCOL E 二 0V006 寸99gxpgCDsal26一A d o。.A-uo sn-EE-0LL5664.900 SavinaVersion 2.0General5Function Description1 GeneralpgCDsal26一A d o。.A-uo sn-EEOL1.OZLCOL EJO山一0 1 0 0 6寸 99gziSavina is a long-term ventilator unit designed for patients with a tidal volume of 50 mL and above,and for the following applications:-Intensive care unit-Recovery room-Secondary transportation from hospital to hospital-Patient transfer within the hospital-Transfer flights1.1 Working principleSavina generates the compressed air for ventilation with a blower,which means Savina is able to ventilate without any connection of compressed air or oxygen.A controllable valve is switched in parallel with the blower to regulate the pre-set ventilation parameters.The valve opens or closes according to the pre-set ventilation parameters.To increase the oxygen concentration in the ventilatory gas,an oxygen concentrator,such as Permox SilentCare from Drager Medical AG&Co.KGaA,can be connected.1 If compressed oxygen is connected to Savina,the oxygen concentration of the ventilatory gas can be precisely metered.The oxygen concentration is then metered internally with sensors,the associated electronics,and a bank of valves.1.2 MonitoringSavina has the following monitoring:-Measurement of the airway pressure(Paw)-Measurement of the expiratory minute volume(MV)-Measurement of the inspiratory O2 concentration(FiO2)-Measurement of the inspiratory gas temperature(T)-Detection of a period of apnea-Detection of dead space-intensive spontaneous breathing(tachypnea monitoring).1-Not yet implemented.5664.900 SavinaVersion 2.0Function Description62Principal componentsSavina consists of the electronics,the operator control unit and the pneumatic system,containing the following principal components:Electronics:Operator control panelPneumatics:-Power pack-Front Panel PCB-Drawer unit-Control PCB-Display-Valve block-Motor Commutation-Membrane keypad-Inspiration blockPCB-02 Valve PCB-Control knob-Pressure measuring unit-02 Diaphragm PCB-Patient systemFanFlow aanacrapgCDsal26一A d o。.A-uo sn-EEOL1.OZLCOL EJO山一0 1 0 0 6寸 99gzi5664.900 SavinaVersion 2.0Function Description72.1 Electronics9zznq00三 Aoup一uosusn0dE 二 PE*一(co0-Ao0_dx o U B d O J C O C H O I B d oo.寸 S E 9 e.寸S 7 9 二.寸S-.9xooq c up tu ainss 一 da s)osusMo-J A2p-5.su-t&S)osusMo-J A2B-dx(17uoq=p。do 0-s 6UZ。一一 MSxoo-qA=Bq-PE1CDodoco。a)ssedAqcood2 n l u l u o ooow8M0-qO E d dA-alpq-eu1Xs d d n s M o d peoquo)昼o OQ 6so Su-BluFig.1:Block diagram of the electronics with operator controlpgCDsal26一A d o。.A-uo sn-EEOL1.OZLCOL EJO山一01006寸 99gzi5664.900 SavinaVersion 2.0Function Description82.1.1 Power packThe power pack delivers the supply voltages for Savina.The input voltage range of the power pack is 100 V to 240 V AC and 50 Hz to 60 H乙 However,the power pack can also be operated with an external rechargeable battery(12 V or 24 V)or with an external on-board-ambulance/helicopter-power supply(10 V to 36 V).The connection for the alternating voltage is made by a power cable.The connection for the external rechargeable battery or the external on-board power supply is made by a coded plug.The power pack actuates the three Mains power,External battery or on-board power supply and Internal battery LEDs.The LEDs are mounted on the membrane keypad of the operator control,and indicate the current operating status.Savina includes 2 internal rechargeable batteries(2 x 12 V)which enable uninterrupted operation in the event of a complete failure of external power.The internal rechargeable batteries supply the O2 sensors with power,even when the Savina is switched off.As a result,valid O2 values are available immediately on power-up.The power pack delivers the following output voltages:-+5V 15 V-+15 V-+24 V-+48 VThe output voltages are short-circuit-proof and stable at no-load.The output voltages are generated according to the following priority,dependent on the input voltages:pgCDsal26一A d o。.A-uo sn-EEOL1.OZLCOL EJO山一0 1 0 0 6寸 99gziInput voltagePriorityActionAC voltage1Charge external and internal batteries,and maintain the charge.External on-board power supply2Charge internal batteries,and maintain the charge.External battery/batteries3Maintain the charge of the internal batteries.Internal batteries4一The fan cools the power pack.The heated air removes excess oxygen from the control unit and warms the patient system.5664.900 SavinaVersion 2.0Function Description92.1.2 Control PCBThe Control PCB is the central control and monitoring unit of the Savina.It includes two separate processor systems:the master and front processors.The program memories are Flash-EPROMs.The Flash-EPROMs can be programmed with a laptop connected to the serial port of the Savina(software download).An EEPROM is provided for each processor system for storage of changeable,nonvolatile data.The EEPROM of the master stores the calibration data of the sensors,fan,etc.The EEPROM of the front processor stores safety parameters,settings such as contrast,sound volume,etc.,as well as a backup copy of the operating hours.The EEPROM of the front processor is plugged in and,if the board needs to be replaced,must be mounted on the new board.The board is provided with a real-time clock which is used to display the time and to store the software options,the unit identification and the operating hours.The realtime clock is buffered by a battery which is integrated in the real-time clock.The realtime clock also holds the logbook.The real-time clock is plugged in and,if the board needs to be replaced,must be mounted on the new board.The Control PCB contains the following functions:-Processing of the signals from the sensors(O2,flow,pressure,temperature)-Control of the blower and valves-Monitoring of the unit functions and the supply voltages-Actuation of the displays-Keypad interpretation-Delivery of the internal and external interfaces.pgCDsal26一A d o。.A-uo sn-EEOL1.OZLCOL EJO山一0 1 0 0 6寸 99gzi5664.900 SavinaVersion 2.0Function Description10F5664900T01IEC.fm 13.12.01For internal use only.Copyright reserved.5 664.900 sav-na Version 2.0 Funci-On D escription-kF9-2:Bock d_agram of ihe coniro-PCBPneumaticsPower switch contactsexternal interfacesAWT 01nurse call RS 232(MEDIBUS)2.1.3 Motor Commutation PCBThe Motor Commutation PCB controls the motor of the blower.The entire control functionality is located in a self-contained housing.The supply voltage is+48 V,and is delivered by the power pack.The+48 V on the Motor Commutation PCB are protected with a fuse(6.3AT).The input voltage range of the Motor Commutation PCB is 12 to 52.5 V.The rotation speed is set by the Control PCB.The control voltage for the rotation speed is 0 to+4.75 V,corresponding to a rotation speed of 0 to 12.500 rpm.The rotation speed range is 300 to 12.500 rpm.The Motor Commutation PCB delivers the actual rotation speed signal to the Control PCB.The actual value signal is 6 pulses per rotation.In the event of discrepancies in the rotation speed the Control PCB adjusts the speed according to the deviation.Fig.3:Block diagram of the Motor Commutation PCBpgCDsal26一A d o。.A-uo sn-EEOL1.OZLCOL EJO山一0 1 0 0 6寸 99gzi5664.900 SavinaVersion 2.0Function Description122.1.4 Oj Valve PCBThe O2 Valve PCB holds the pressure sensors(2x absolute pressure S6 and S7,1x O2 supply pressure S5),the actuator for the O2 calibrating valve and the nebulizer valve,and the actuator for the valve block.The signals from the pressure sensors are amplified and passed to the Control PCB.The+5 V voltage supply to the pressure sensors is generated on the O2 Valve PCB.The valves in the valve bank,the O2 calibrating valve and the nebulizer valve can be operated individually by an electronic switch.They are actuated by the Control PCB.02 Valve PCBFig.4:Block diagram of the 02 Valve PCBpgCDsal26一A d o。.A-uo sn-EEOL1.OZLCOL EJO山一0 1 0 0 6寸 99gzi5664.900 SavinaVersion 2.0Function Description132.1.5 Oj Diaphragm PCBThe O2 Diaphragm PCB amplifies the signals from the O2 sensors and measures the temperature of the O2 sensors and of the respiratory gas in the inspiration block.The temperature of the O2 sensors is required to compensate for the temperaturesensitive O2 measurements.The calibration data from the sensors are stored on the Control PCB in an EEPROM.The reference voltage of the O2 sensors is generated from the voltage of the rechargeable batteries,and so is also available when the unit is switched off.The operating voltages of the O2 Diaphragm PCB are+5 V and+15 V.02 Diaphragm PCBFig.5:Block diagram of the 02 Diaphragm PCB2.1.6 FanThe fan takes in ambient air through the cooler of the blower and cools the blower.The air flow also removes excessive oxygen from the device.The voltage supply to the fan is+24 V.The rotation speed of the fan is controlled by the Control PCB.pgCDsal26一A d o。.A-uo sn-EEOL1.OZLCOL EJO山一0 1 0 0 6寸 99gziFig.6:Fan control5664.900 SavinaVersion 2.0Function Description142.2 Operator Control PanelThe operator control panel is the interface between the unit and the user.It is used to enter and display the ventilation parameters.Fig.7:Operator control panel2.2.1 Front Panel PCBThe Front Panel PCB contains the 7-segment displays for the pre-set ventilation parameters,the drivers for the key LEDs,the drivers for interpretation of the keys and the shaft encoder,and the voltage generator for backlighting of the display.The voltage generation for the backlighting can be switched on and off from the Control PCB.pgCDsal26一A d o。.A-uo sn-EEOL1.OZLCOL EJO山一0 1 0 0 6寸 99gzi5664.900 SavinaVersion 2.0Function Description15Front Panel PCBFig.8:Block diagram of the Front Panel PCB2.2.2 DisplayThe display shows the patient parameters and the warning messages.The display is actuated by the Control PCB;the display backlighting is actuated by the Front Panel PCB.The display resolution is 240 x 128 pixels.The voltage supply is+5 V and 15 V.2.2.3 Membrane keypadThe membrane keypad contains the keys,with associated LEDs,to operate Savina.2.2.4 Control knobThe control knob is used to set and confirm changeable ventilation parameters.The control knob transmits square signals to the Front Panel PCB as it rotates,and the signals are then evaluated by the Control PCB.The voltage supply is+5 V.pgCDsal26一A d o。.A-uo sn-EEOL1.OZLCOL EJO山一0 1 0 0 6寸 99gzi5664.900 SavinaVersion 2.0Function Description16F5664900T01IEC.fm 13.12.01For internal us