Home

Semiautomatic defibrillator (PAD) Service Manual Version 01.00

image

Contents

1. DE oO N UZ AGLOMMOOWD cia H Cis cigs C17
2. 3 10 0012 3 10 0011 3 10 0011 code article c ble cable PN 3 10 0012 code article c ble cable PN pas mont not mounted Dimensions extr mes 210m
3. UZI ARGIQOMNMONWD R236 C126
4. N A cio Ri78 C29
5. L TR1 violet nm 2 TR1 Blanc white
6. R143 RSF p30 al iz F a 3 10 0012 3 10 0011
7. N g i KIE CSS R244 R225 RAS R240 R239 10 0011 code article c ble cable PN 10 0012 code article c ble cable PN ds ae pas mont not mounted Dimensions extr mes 210mm X 186 5mm FRED EASY Circuit D fibrillateur Defibrillator PCB APPROV MODIFICATION ART WSM0008A NF
8. Gr C170 R261 Rise Rie7 C169 R253 C168 R22 C174 gt R259 R256 pas mont not mounted APPROV MODIFICATION NF CK CK ECL200 11 02 ECL200 11 02 ECL201 02 03 FRED EASY Circuit CPU CPU PCB ART WSMO005A PRT WSMO0005 PCB2 DG WSMO0005AREF200 SHT 1 2 SCHI MEDIC LLER Etiquette N s rie pas mont not mounted Tous les TP ne sont pas mont s All the TP are not mounted APPROV FRED EASY Circuit CPU CPU PCB MODIFICATION NF CK ART
9. R23 p LND a al 8 EN U45 Z Riss R67 Rize C25 coy 2 a C1638 R253 174 R257
10. FRED EASY Circuit CPU CPU PCB Ci70 R261 R259 R256 DRAWN APPROV MODIFICATION ART WSM0005A NF CK CK PRT WSM0005_PCB3 ECL300 ECL300 ECL301 DG WSM000S5AREF300 SC H L L E R 02 03 02 03 05 03 SHT 1 2 CEJ Bim re Ra pas mont not mounted MEDICAL S A Etiquette N s rie pas mont not mounted Tous les TP ne sont pas mont s All the TP are not mounted APPROV FRED EASY Circuit CPU CPU PCB MODIFICATION NF CK ART WSM0005A CK PRT WSM0005_PCB3 ECL300 02 03 ECL300 02 03 ECL301 DG WSM000SARE300 SC H l L L E R 05705 SHT 2 2 MEDICAL Diagrams and layout drawings 7 2 Defi circuit WSM0008A CONFIDENTIAL Part no 0 48 0029 7 4 May 2003 Sch mas et plans d implantation WSM0008_PCB2 Art N 0 48 0015 7 5 Mai 2003 Etiquette
11. RE OONA DAWN AWN HO Cis cies C17 C24 21 QO hare 00 eu D2
12. C24 21 R302 2 R94 en gt N i SE COOONIACI AGN HUONO C152 C144 C N R235 C126
13. LHVC Load High Voltage Capacitor Logical signal that directly activates the HV generator in order to charge the HV capacitor The signal is active throughout the HV capacitor charge phase till charging stops gt input signal LHVC is active when high active at 5 V EPDU Enable Patient Discharge Unit Logical signal that powers the shock delivery hardware circuit by means of a transistor The signal is active throughout the hold phase till the shock is administered gt input signal EPDU is active when high active at 5 V UPRA Microcontroller Patient Relay Activation Logical signal from microcontroller U36 that activates a way for triggering the patient relay by means of a transistor The signal is active for 100ms during the defibrillation shock gt input signal UPRA is active when high active at 5 V SHOCK_KEY Shock Key Logical signal coming directly from the Shock key on the CPU PCB gt input signal SHOCK_KEY is active when low when the Shock key is pressed OV if the key is pressed ECGRA ECG Relay Activation Logical signal that controls the ECG relay coil through a transistor function When the device is switched on the ECG relay must be activated in order to transmit the patient ECG signal to the ECG preamplifier During the defibrillation shock the ECG relay control deactivates the coil for 100ms in order to insulate the ECG preamplifier part from the high voltage circuit when the patient relay is a
14. Schema No WSMO0005_SYN2 S CHILLER _ Date 08 0 1 03 rs ee S ZAE Sud BP50 Sheet 6 of 10 67162 WISSEMBOURG CEDEX Technical description of boards LCD display The LCD display is under the control of the ColdFire processor through data bus B_D 24 31 The LCD registers are written through latch U43 It is controlled by signal LCD _R_W generated by latch U42 and through an OR gate by signals WE and CS4 of the ColdFire processor The LCD registers are re read through latch U44 which is controlled by signal LCD_ENAB generated by latch U42 through an OR gate by signals OE and CS4 of ColdFire The various control signals LCD CS1 LCD_CS2 LCD_CS3 LCD REG SELECT LCD R_W and LCD_ENAB are provided from the data bus through latch U42 It is controlled through an OR gate by signals WE and CS1 of the ColdFire processor The screen is powered with 5 V via R114 and R277 and VEE via R275 and R276 The contrast is adjusted by means of VR1 The nominal contrast adjustment is around 8 V All links with the LCD screen are filtered by RC networks Part no 0 48 0029 5 17 May 2003 CS 0 7 Microcontroller Process Unit LCD Interface gt B_D 16 31 LCD_REG_SELECT LCD_R_W CS0 7 LCD_ENABLE LCD_CS1 LCD_CS2 LCD_CS3 LCD_CDB 0 7 lt J LCD Interface Project 01 58 E 09 PCB No WSMO005_PCB2 Size A4 Drawn by JME NF Art No WSMO005A
15. CK PRT WSM0008 PCB3 DGW WSM0008AREF300 sc HILLE R ECL300 ECL300 01 03 01 03 SHT 1 1 MEDICAL S A
16. d This operation relates to the high voltage capacitor which can carry fatal charges Before starting to work take care to discharge the high voltage capacitor completely The terminals of the high voltage capacitor must never be touched directly The high voltage capacitor may never be replaced by people other than specially authorised and trained personnel Part no 0 48 0029 Page 4 3 May 2003 Replacement of parts The replacement of the high voltage capacitor is an extremely rare operation as the life of the capacitor is very long However if needed the high voltage capacitor may be replaced in accordance with the following instructions 1 Disconnect the two Faston lugs 2 Take the capacitor off its support CE After removing the fully discharged high voltage capacitor from the lower part short the three terminals of the capacitor with conducting wire While replacing the high voltage capacitor glue it to the support twist the wires and wire them in accordance with the polarity requirements The wires are to be routed as required Make sure that nothing has been forgotten before the device is started up again m rs ETTET e Pee seceseseeees 2 ee gt ecu Caution This operation relates to an essential component of the high voltage part It may only be performed by specially authorised personnel who have been trained in repairing FRED easy devices The delivered energy must undergo test
17. During the replacement of one of the boards it should absolutely be seen whether the versions are compatible by consulting the table available at Schiller Medical Only the versions are compatible which comprise a HARDWARE number in the table of the versions Caution On your device the HARDWARE version number perhaps consulted only with the module of remote loading For each replacement of chart it is necessary to charge the good number of HARDWARE version given speaks table Caution A general device test shall be performed each time the device is opened Part no 0 48 0029 Page 4 1 May 2003 Replacement of parts 4 1 Device disassembly procedure Follow the points below while disassembling the device 1 2 Remove the Lithium cell from its slot Disconnect the electrode cables Turn the device over LCD screen down and unscrew the nine assembly screws of the two upper and lower halves of the housing After removing the nine screws turn the device over LCD screen facing you The upper half can now be removed by pulling it up gently The electrode connections to the left and the speaker to the right of the device may offer some resistance In order not to pull off the speaker wires hold it in the lower part while removing the upper part Caution Take care not to lose the caps of the control buttons placed in the upper part Part no 0 48 0029 Page 4 2 May 2003 Replacement of parts 4
18. Schema No WSM0005_SYN2 Date 09 01 03 Sheet 7 of 9 SCHILLER _ MEDICAL S A 4 rue Louis Pasteur ZAE Sud BP50 67162 WISSEMBOURG CEDEX Technical description of boards AD converter The AD converter U35 is under the control of the ColdFire processor through an SPI serial link QSPICLK SPICSO SPI_ DATA OUT and SPI_DATA_IN Line EOC end of convert is a converter status signal that informs the ColdFire processor of the end of conversion and the availability of the converted data The converter resolution is 10 bits and its voltage reference 2 5 V is supplied by D36 The AD converter has eight multiplex analogue inputs that enable it to digitise the following signals e Z ELEC DEFI analogue signal from the defibrillator Carries patient impedance information Before being applied to the converter signal Z ELEC DEF is divided by two with resistors R351 and R352 The signal is filtered from the EMC point of view at the input of the CPU board by a T filter made up of R186 C134 and R194 e ECG LB analogue signal from the defibrillator Carries ECG information with a narrow bandwidth 0 05Hz 1Hz The signal is filtered from the EMC point of view at the input of the CPU board by a T filter made up of R185 C135 and R193 e ECG ADC analogue signal from the defibrillator Carries ECG information with a wide bandwidth 1Hz 25Hz Before it is applied to the input of the ADC signal ECG_ADC is conditioned by the analo
19. WSM0005A CK PRT WSMO0005 PCB2 ECL200 11 02 ECL200 11 02 ECL201 DG WSM0005ARE200 SC H l L L E R 02 03 SHT 2 2 MEDICAL Sch mas et plans d implantation WSM0005_PCB3 Art N 0 48 0015 7 3 Mai 2003
20. 100ms signals UPRA and SHOCK_KEY and the IGBT control circuit The IGBT control circuit controls the IGBT HV switching stage in order to generate a patient impedance compensated pulse biphasic waveform signals FPIC and SPIC During the first pulse of the defibrillation waveform current the high voltage circuit measures the value of the patient current signal IPAT That information enables the defibrillator control circuit to determine the patient resistance in order to control the IGBT control circuit The high voltage circuit is also used for the HV capacitor safety discharge through a power resistor and the safety discharge relay The HV capacitor safety discharge is controlled by the defibrillator control circuit signal WDRA The safety discharge may be initiated either directly by the defibrillator circuit microcontroller or by information transmitted by the serial link from the CPU board Patient insulation from the high voltage circuit The patient is insulated from the high voltage circuit by the open contacts of patient relay RL5 and RL6 The ECG signal collected by the adhesive electrodes is transmitted to the ECG preamplifier by relay RL7 The ECG relay is activated when the device is switched on by transistors Q25 Q26 and driver U34D The ECG relay coil is directly powered by voltage UBAT_FUSED Signal ECGRA which controls U34D is taken from the coil of RL6 in order to deactivate relay ECG RL7 during the defibrillation shock HV
21. 2 Working on the CPU circuit Follow the instructions below to remove the CPU 1 Remove the six rubber washers 2 Disconnect the CPU from the connector to the rear of the device near the battery slot 3 Take off the buzzer and the speaker of the lower housing and carefully pull the connectors Caution The circuit includes components that are sensitive to electrostatic discharge The work described above shall be performed in accordance with ESD rules 43 Working on the LCD display After removing the CPU PCB the LCD display can be removed by following the instructions below 1 Carefully remove the connector of the backlighting circuit connected to the CPU 2 Remove the connector of the flat jumper 3 Unscrew the four screen fastening screws The liquid crystal display is a version with backlighting The two functions cannot be dissociated If the display is to be replaced make sure the new screen is clean Never clean the surface of an LCD screen with cloth or paper that could be very slightly abrasive and scratch the screen Any dust should be removed by blowing compressed air 4 4 Working on the DEFI circuit To remove the DEFI circuit remove the spacers and pull out the circuit which is just placed inside the housing w Caution The circuit includes components that are sensitive to electrostatic discharge After the PCB is disconnected from the device comply with ESD rules 4 5 Replacing the high voltage capacitor
22. 2003 Technical description of boards Note When the device is started up a buzzer alarm is emitted while the ColdFire processor is booting Its duration is limited to 16 seconds maximum During that time the buzzer alarm does not code for technical faults The persistence of the buzzer alarm beyond sixteen seconds imperatively indicates a technical fault Part no 0 48 0029 5 13 May 2003 Status Led Indicator AlarmBuzzer Oscillator Alarm Buzzer and Driver BUZZER E SWITCHED_GND Le Sheet 12 20 gt SWITCHED_GND UBAT_FUSED_CPU gt UBAT_FUSED_CPU LED STATUS CMD_FLASHING_LED_ON SET_ALARM_ON gt CMS_FLASHING_LED_ON DS SET _ALARM_ON Sheet 11 20 RESET gt RESET INH2 Sheet 10 20 Status Led Indicator AlarmBuzzer Schema No WSM0005_SYN2 S C H l L L E R Project 01 58 E 09 PCB No WSM0005_PCB2 Date 08 01 03 4 ue Louis Pasteur Size A4 Drawn by JME NF Art No WSMO005A Sheet 5 of 9 D Wie sR CEDEX Technical description of boards Multimedia Card MMcard interface The MMcard interface is made up of a special connector JP5 which is used to receive memory cards of the MMC Multi Media card and SDC Secure Digital Card type During use they are used to record ECG signals environment sounds and events relating to the procedure The MMcard is under the control of the Cold
23. 95A patient resistance 30Q gt signal IPAT is located between 0 V and 4 V at the most gt scale factor IPAT V peak A 35 with peak patient peak current THVM Transformer High Voltage Measurement Analogue signal offering the first way to measure the charge voltage of the HV capacitor The measurement is taken through the primary winding of the HV capacitor Signal THVM is applied by microcontroller U36 to stop charging the HV generator gt signal THVM is located between 0 and 4V at the most gt scale factor THVM V U pr V 850 where U pr HV capacitor charge voltage CHVM Capacitor High Voltage Measurement Analogue signal offering the second way to measure the charge voltage of the HV capacitor This measurement is taken by means of a voltage divider with a high resistive value referenced to the ground Signal CHVM is applied by microcontroller U36 and transmitted by a serial link to the host CPU to display the stored energy corrected for 50Q The signal must also be used if there is any fault in charge stopping through FDU The maximum charge voltage must not exceed 3 4KV gt signal THVM is located between 0 and 4V at the most gt scale factor CHVM V U pr V 850 where U pr HV capacitor charge voltage CTFC Charge Transistor Fault Condition Analogue signal to detect any short circuit in the charge transistor that charges the high voltage unit The transistor is considered to fai
24. DEFI circuit 7 Diagrams and layout drawings 7 1 CPU circuit WSM0005A 7 2 Defi circuit WSM0008A Part no 0 48 0029 Page VI May 2003 1 1 1 1 1 2 1 3 1 3 1 6 1 7 2 Testing and maintenance 2 1 2 1 2 3 2 3 3 1 4 1 4 2 4 3 4 3 4 3 4 5 4 5 5 1 5 1 5 28 5 33 5 40 5 43 5 43 5 44 5 48 5 50 5 52 6 1 6 1 6 1 6 1 7 1 7 1 7 4 Operation 1 Operation This section briefly outlines the operating of the device For more detailed information please refer to the Users Manual 1 1 Display and controls The green indicator lamp flashes when the device is ready to operate The yellow indicator lamp flashes as long as the electrodes are not in place Connection of adhesive electrodes Green D key to switch the device on and off and start analysing Key for triggering the defibrillation shock Memory card optional Battery Qo D Q 0 ao Part no 0 48 0029 Page 1 1 May 2003 Operation 1 2 Explanation of symbols used Symbols on the device or accessories BF type signal input protected from defibrillation Caution High voltage Expiry date for the use of defibrillation electrodes Follow the instructions for use Open the electrode packaging Remove the protective film Single use only Do not reuse Do not fold the packaging Storage temperature range Symbols displayed on the screen Number of shocks
25. SPI_CS3 SPI_DATA_IN SPI DATA OUT SYNC_FST SYNC_POWER_BURST TEST TYPE_ELECTR TXD_DEFI TXD_GSM TXD_MC35 UBAT UBAT_FUSED_CPU Part no 0 48 0029 GSM telephone external microphone input GSM telephone external microphone input Configuration signal of port BDM and JTAG Not involved in device operation Signal generated by ColdFire to indicate that data bus reading is under way ADPCM decoder FIFO status signal Signal resulting from the activation of key ONOFF ANALYSE Signal for reinitialising the ADPCM encoder and putting the audio amplifier into standby position Signals of port BDM and JTAG Not involved in device operation Saved signal of SHOCK key activation Saved signal of ONOFF_ANALYSE key activation Clock signal of the SPI serial link SDRAM control signal Reset signal generated by the ColdFire processor Applied to the defibrillator microcontroller Reset signal controlled by the ColdFire processor Active when low Reset signal generated by the voltage supervisor Active when low Square signal generated by the clock and transmitted to the ColdFire processor RS232 serial communication link between the ColdFire processor and the defibrillator Signal generated by the ColdFire processor RS232 serial communication between the ColdFire processor and an external PC Signal generated by the ColdFire processor PC bus clock PC bus serial data SDRAM address bank control signal SDRAM bus cl
26. U24C leads to polarisation at a voltage of 5 V by R79 of signal Z_ELEC_DEFI In those conditions signal Z_ELEC_DEFI becomes greater than 3 5 V which is signalled by message CONNECT ELECTRODES The ECG preamplifier also supplies signal ECG_LB to the CPU board Signal ECG_LB is the ECG signal from the output of U22A with a lower bandwidth extended to 0 05Hz The stage with the lower bandwidth extended to 0 05Hz is made up of U12A and U12B U12A is mounted as a voltage follower in order to attack analogue switch U27 controlled by signal INH_PACE The low pass filter is made up of elements C99 and R122 If signal ECG_LB is exceeded signal BACK_OO5HZ generated by the CPU board modifies the bandwidth below approximately 1 6Hz by means of analogue switch U28 The upper cut off frequency of signal ECG_LB is limited to 1Hz by R266 and C104 The gain of signal ECG_LB is 250 Signal ECG_LB is polarised at 1 25 V through the reference 1 25 VREF generated by U11D Verification of the ECG signal acquisition circuit The ECG signal acquisition chain is verified when the power is switched on by means of the 10 Hz signal generated by the CPU board The 10 Hz signal between 5 V and 5 V controls transistor Q22 which generates a differential signal with an amplitude of approximately 1 5mV through U12C and U12D The signal is injected at the input of the differential amplifier through analogue switches U24A and U24B and resistors R46 and R47 The control signal of U2
27. a make contact of the ECG relay During defibrillation shocks signal ECG1 is insulated from the Defi connector for 100ms gt signal ECG insulated from the Defi connector during the defibrillation shock ECG2 ECG signal from the Defi connector ECG signal from the Defi connector transmitted by a make contact of the ECG relay During defibrillation shocks signal ECG2 is insulated from the Defi connector for 100ms gt signal ECG insulated from the Defi connector during the defibrillation shock APEX Apex electrode of the Defi connector Link between the defibrillator part and the patient through the patient electrode connector This link is used to collect the ECG signal and patient defibrillation gt link insulated from the HV part by the patient relay STERNUM Sternum electrode of the Defi connector Link between the defibrillator part and the patient through the patient electrode connector This link is used to collect the ECG signal and patient defibrillation gt link insulated from the HV part by the patient relay 5 3 7 IGBT control circuit Input signals of the IGBT control circuit PBSBO Patient Bank Selection Bit 0 First of the three encoded bits used to select the different EPROM banks depending on the calculated patient impedance gt signal PBSBO is active when high active at 5 V PBSB1 Patient Bank Selection Bit 1 Second of the three encoded bits used to select the different EPROM banks depending
28. and measuring the charge voltage and patient current during defibrillation shocks e IGBT control circuit The IGBT control circuit part controls the IGBTs of the high voltage unit in order to generate a patient impedance compensated pulsed biphasic waveform e Fault detection circuit The fault detection circuit monitors the critical component in order to detect any fault Operating of the defibrillator part The explanation of the operating of the defibrillator part refers to the chart of the FRED EASY Defibrillator General description The defibrillator circuit includes three connectors e a connector two high voltage contacts for connecting adhesive electrodes e aconnector six contacts for connecting to the lithium cell e aconnector 32 contacts for connecting to the CPU board The power circuit of the defibrillator part which is used to charge the high voltage capacitor is directly powered from the lithium cell protected by a fuse voltage UuBAT_FUSED The circuits that control the defibrillator and the IGBTs and detect faults are powered by the 5V voltage generated by the CPU board The ECG preamplifier circuit is also powered with 5 V and the 5 V voltage generated on the CPU board The voltage references used by the defibrillator part are generated locally on the defibrillator circuit Part no 0 48 0029 5 28 May 2003 Technical description of boards The defibrillator function of FRED Easy is a sequential circuit with si
29. breaths and chest compression Push button to initiate ECG analysis Analysis in progress do not touch the patient Shock advised Shock advised do not touch the patient trigger shock After 3 shocks or when no more No shock advised shocks advised Check for signs of circulation Check for signs of circulation If no signs of circulation If no signs of circulation rescue breaths and rescue breaths and chest compression chest compression CPR for 1 minute CPR for 1 minute Call for professional help Part no 0 48 0029 Page 1 5 May 2003 1 5 Operation Recording optional For information the memory board can save the following half an hour of ECG half an hour of speech 500 events relating to the procedure see overview opposite Plugging in a memory card activates the memory function and the display includes the icon W The memory card is analysed by means of a PC with the SAED Reader software Icon LU flashes when the memory card is full Important The device must be switched off when you insert the card Otherwise the device will not recognise the card and will display the following symbol If no symbol is displayed even after the card has been put in place you must make sure that the card is indeed a card designed for such devices by SCHILLER Part no 0 48 0029 Page 1 6 May 2003 Operation 1 6 Technical specifications e Form of the defibri
30. capacitor charging to a set energy value After receiving a request for charging to a set energy value microcontroller U36 checks signal CTFC in order to make sure that there is no voltage at the drain of charging transistor Q1 When that condition is fulfilled signal EHVG switches to low making Q1 conduct Conduction by charging transistor Q1 leads to the appearance of voltage UCHARGE Microcontroller U36 also controls the activation of the safety discharge relay RL4 by signal WDRA and transistor Q5A In those conditions the contacts of the safety discharge relay RL4 are open enabling the charging of the HV capacitor HV capacitor charging is started by means of signal LHVC which switches to high When signal LHVC is high the HV generator built around U6A U3 Q4 and associated components makes the HV capacitor charge 40uF 3 1KV by means of HV transformer TR1 Measurement of the charge voltage of the HV capacitor The charge voltage of the HV capacitor is measured through two different circuits The first circuit that measures the charging voltage of the HV capacitor is made up of resistors R186 R187 and R196 which directly collect the charge voltage from the terminals of the HV capacitor Signal HV_M Part no 0 48 0029 5 36 May 2003 Technical description of boards generated by the resistive divider attacks amplifier U2A which supplies signal CHVM used as the measurement signal by microcontroller U36 Signal CHVM is the charge voltag
31. given since starting up Battery capacity Memory card Memory card not found Adult electrode detected Child electrode detected Bic gt OF HT Time since the machine was started up minutes and seconds Part no 0 48 0029 Page 1 2 May 2003 Operation 1 3 Device operation FRED easy is a battery operated semiautomatic defibrillator that provides biphasic defibrillation pulses Defibrillation takes place by means of single use adhesive electrodes through which the ECG signals required for the analysis are also collected Adhesive electrodes are available for children and adults The device recognises the type of electrode applied and selects the defibrillation energy values accordingly The user is provided with written and audio instructions display and loudspeaker relating to the use of the device The power is supplied by plug in disposable lithium batteries Their capacity is sufficient for 200 shocks at the maximum power rating or use of the monitor for seven hours cyclical 30 minutes on 30 minutes off or 5 years standing by As soon as a battery is put in place in the FRED easy device it runs a self test to check the status of the device and battery If the device does not find any fault the green indicator begins to flash to show that it is ready to operate and the display disappears Likewise the device runs a self test each time it is switched on If during th
32. gt Vref INH_PACE DEFIBRILLATOR Pacer Detection INH_PACE gt ECG_DEFI DETECT_PACE gt DETECT_PACE ECG PACE TEST lt ECG _PACE_TEST BLOCK_PACE lt BLOCK_PACE Level Adapter 10Hz BACK_005HZ INH_PACE lt _j 10HZ INH_PACE_4066 10HZ_4066 BACK_005HZ y Schema No nalog Processing of ECG A D conversion WSM0005_SYN2 SCHILLER Project 01 58 E 09 PCB No wsmoo05 PcB2 Date 09 01 03 tous Pasteur Size A3 Drawn by JME NF rt No WSMO005A Sheet 8 of 9 EEE a E CEDEX Technical description of boards ADPCM decoder The ADPCM decoder is controlled by the ColdFire processor through data bus B_D 16 31 and control and status signals CS2 OE WE BAO RSTO and OKI FIFO MID The operating frequency of the decoder is 4 096MHz It is provided by the intermediate clock generation function that is built around U2 The ADPCM decoder issues an analogue output on its output AOUTL UU4 28 The signal is applied to an audio amplifier through capacitive connection C104 Audio amplification The audio amplifier is built around circuit U5 The three signals to be amplified come from the ADPCM decoder output 28 of U4 the ADPCM encoder BF_PCM_MOTOROLA and the GSM option SPEECH _GSM_PLUS and are brought to the audio amplifier via a capacity connection mixer built around U6A Through a capacitive link C62 that also takes care of high pass filtering the audio signal is pre ampl
33. shock A defibrillation shock is delivered by pressing key S2 Pressing key S2 forces signal CHOC KEY to zero That status is saved by latch U11B the output PUSH_BUTTON_CHOC of which switches to high 3 3 V The signal is transmitted to the ColdFire microprocessor Latch U11B is reset through transistor Q6 and signal CMD FLASHING LED ON generated by the ColdFire processor Part no 0 48 0029 9 9 May 2003 Technical description of boards Note Key S2 is only active when it is lit The Shock key is lit by two green LEDs D18 and D19 The lighting of the LEDs is controlled through transistors Q7 and Q8 and signal CMD LED CHOC generated by ColdFire 3 3V power supply voltage supervisor The 3 3V power supply voltage is supervised by circuit U10 which gives the reset pulse when the device is started up and supervises the 3 3V power supply voltage when the device is operating Any drop in voltage below 3V triggers reset pulses Clock Clock U9 is controlled by ColdFire through data bus B_D 16 31 address bus BA 0 7 and control signals CS3 OE and WE In addition to its real time clock calendar function the clock also wakes the device once a week and provides the PWR control signal to start up the device Entry KS of clock U9 24 associated with output PWR starts up the device This function has been described in greater detail in sections Device starting up upon the insertion of the power cell and Starting up and swi
34. the HV circuit The high voltage circuit insulates the patient from the high voltage unit of the defibrillator by means of the two patient relays The defibrillator charge circuit is directly powered by the lithium cell via the charging transistor signal EHVG The HV capacitor is charged by the HV generator signal LHVC While the HV capacitor is being charged the safety discharge relay is also active signal WDRA While the HV capacitor is being charged the HV generator supplies a signal for measuring the charging voltage through the HT converter primary winding signal THVM The signal is used by the defibrillator control circuit to determine the energy stored in the HV capacitor When the energy stored in the HV capacitor is equal to the energy defined in the CPU board the HV generator is deactivated which stops charging When the defibrillator is in the hold phase the charge voltage is measured by a high voltage divider at the terminals of the HV capacitor signal CHVM During the charging and hold phases the high voltage circuit actively blocks the IGBTs of the HV switching circuit through the pulse transformers associated with the IGBTs The active blocking of the IGBTs is controlled by the IGBT control circuit signals FPIB and SPIB During the entire duration of the hold phase patient relay control stage activation is authorised signal EPDU When the Shock key is pressed the defibrillator control circuit activates the patient relay for
35. the board NN is reset to 00 when the version of P is changed 6 2 CPU circuit WSMO005A Modifications First board version Modification 03 37 12 Layout has be change in PCB3 WSMO005A WSMO005A 6 3 DEFI circuit WSMO008A First board version Modification 03 55 21 Change of C167 C168 C169 R391 et R392 value WSMO005A 201 Modification 03 21 04 D2 D4 replaced by diodes BAS70 05 R333 and Q29 removed D46 diode BAS70 05 added instead of Q29 Modification 03 36 11 Layout has be change in PCB3 WSMO008A Part no 0 48 0029 6 1 May 2003 Diagrams and layout drawings 7 Diagrams and layout drawings 7 1 CPU circuit WSMO005A CONFIDENTIAL Part no 0 48 0029 7 1 May 2003 Diagrams and layout drawings WSM0005 PCB2 Part no 0 48 0029 7 2 May 2003
36. the high voltage capacitor Information corresponding to the application of the defibrillation shock Information corresponding to the safety discharge phase Information corresponding in real time to the energy stored during the charging phase or the high voltage capacitor hold phase Information corresponding to the energy delivered when the defibrillation shock is applied Information corresponding to the peak current when the defibrillation shock is applied Information corresponding to the identification of the adhesive electrodes used Information corresponding to the pressing of the ANALYSE key Information that leads to a battery test Information corresponding to the energy selected in the semiautomatic mode depending on the protocol AHA ERC or other e Information corresponding to the triggering of the preliminary charge at the selected energy value e Information corresponding to the triggering of the charge at the selected energy value e Information corresponding to the safety discharge of the high voltage capacitor 5 3 1 Driving the high voltage capacitor charge Standby phase During the standby phase microcontroller U36 dialogues with the master microprocessor of the CPU board through the serial link The high voltage circuit of the defibrillator part is disabled The control of high voltage capacitor charging is initiated by the master microprocessor of the CPU board via the serial link Two signals are used to trigger the ch
37. to measure the charge voltage of the HV capacitor This measurement is taken by means of a voltage divider with a high resistive value referenced to the ground Signal CHVM is applied by microcontroller U36 and transmitted by a serial link to the host CPU to display the stored energy corrected for 50Q The signal must also be used if there is any fault in charge stopping through FDU The maximum charge voltage must not exceed 3 4KV gt signal THVM is located between 0 and 4V at the most gt scale factor CHVM V U pr V 850 where U pr gt HV capacitor charge voltage THVM Transformer High Voltage Measurement Analogue signal offering the first way to measure the charge voltage of the HV capacitor The measurement is taken through the primary winding of the HV capacitor Signal THVM is applied by microcontroller U36 to stop charging the HV generator gt signal THVM is located between 0 and 4V at the most gt scale factor THVM V U r V 850 with U 4 HV capacitor charge voltage IPAT Patient Defibrillation Current Analogue signal corresponding to the measurement of the patient current during defibrillation shocks The signal is used to compensate the pulse biphasic wave for the patient impedance With a maximum charge voltage of 2840V the maximum patient current is 95A patient resistance 300 gt signal IPAT is located between 0 V and 4 V at the most gt scale factor IPAT V peak A 35 where p
38. to optimise the use of the power cell Power cell voltage monitoring The power cell voltage is taken from UBAT_FUSED_CPU through dividing bridge R105 and R127 The resulting signal CHEK_BAT_VOLTAGE 5 is transmitted to the ADC The role of transistors Q4 and Q31 is to prevent leakage current from flowing to the ground and in the input of the CAD when the device is off no 3 3V Backup cell voltage monitoring The voltage of backup cell V_LITH is taken at the anode of D37 and transmitted through transistor Q34 to ADC converter U35 The role of the function built around Q34 and Q35 is to prevent leakage current from flowing to the ADC input when the device is switched off Signal CHECK_CR2032 generated by ColdFire controls the connection between the backup cell and the ADC input Part no 0 48 0029 5 20 May 2003 Analog Processing of ECG A D conversion Checking of Lithium Backup Battery voltage COLDEIRE CHECK_CR2032 lt CHECK_CR2032 A D CONVERTER LITH_BAT_VOLTAGE gt LITH_BAT_VOLTAGE Checking of Power Supply Battery voltage CHECK_BAT_VOLTAGE S gt CHECK_BAT_VOLTAGE S Temperature TEMPERATURE gt TEMPERATURE EOC_ADC l SPI_DATA_IN F lt SPI_DATA_IN QSPICLK lt _ QSPICLK SPI_DATA_OUT SPI_DATA_OUT SPILCSO Z_ELEC_DEFI gt Z_ELEC_DEFI ECG LB DELTA _Z Vref Amplification Filters ECG_DEFI gt ECG_DEFIECG_ADC Vref I
39. 096 and synchronisation signals BCLKT and SYNC_FST are chiefly used by the ADPCM encoder and decoder All these signals are generated from clock CPU_CLK 40 96MHz Intermediate clock generation is achieved by the binary counters of programmable circuit U2 Asynchronous counter U3 is essentially used to prepare synchronisation signals BCLKT and SYNC_FST Part no 0 48 0029 5 22 May 2003 Microcontroller Process Unit t gt B_D 16 31 RSTO CS2 RSTO CS2 OE WE OKI_FIFO_MID POWER_DOWN_AUX OE WE OKI_FIFO_MID Encoding Decoding ADPCM Audio Amplification AOUTL CLK4MO96 lt SPLCS1 POWER_DOWN_AUX QSPICLK SPI_DATA_OUT SPI_DATA_IN DATA_CODEC_RX SPI_CS1 QSPICLK SPI_DATA_OUT SPI_DATA_IN DATA_CODEC_RX ADPCM_ENCODE lt _ ADPCM_ENCODE SYNC_FST BCLKT CLK20M48HZ gt POWER_DOWN_AU BF_PCM_MOTOROLA To Loudspeaker SPEECH_GSM_PLUS lt SPEECH_GSM_MINUS lt _ BF_PCM_MOTOROLA MIKE_GSM_PLUS MIKE_GSM_MINUS Form Electret Microphone lt _ CS decoder GAL22LV10 Secondary Clock Generator GAL22LV10 Binary Counter FST_INHIB CLK4M096 CLK20M48 CPU_CLK ADPCM Encoder control signal GAL22LV10 Binary Counter BCLKT SYNC_FST sheet 6 20 s FST_INHIB CPU_CLK To Loudspeaker PAS Dee
40. 1 and PBSB2 During that phase the IGBTs are controlled by the IGBT control circuit to generate the patient impedance pulse biphasic waveform After a duration of 100ms signal UPRA deactivates the patient relay and disables the IGBT control circuit The microcontroller deactivates all the outputs The energy remaining in the high voltage capacitor is dissipated into the safety discharge circuit During the defibrillation shock the microcontroller calculates the energy delivered and transmits the value and the peak current and patient resistance to the CPU board Self test of the defibrillator part When the 5 V power supply voltage generated on the CPU board appears circuit U29 resets the microcontroller of defibrillator control circuit U36 Circuit U29 also monitors the 5 V power supply voltage and resets U36 if it fails The master microprocessor of the CPU board can also reset U36 by means of signal RST_DEFI and transistor Q18 The voltage reference of the ADC internal to U36 is made up of U30 When the FRED Easy device is started up microcontroller U36 of the defibrillator control circuit runs a self test of the defibrillator part During the self test microcontroller U36 performs the following operations e configuration of input output ports verification of the operating of the serial link with the CPU board verification of program integrity verification of the operating of the fault detection circuit verification of the operating of t
41. 222 in parallel with R224 Control by the ColdFire processor of the parallel connection of R224 with R222 increase the 3 6 V voltage during the emission phase of the mobile phone 3 3 V voltage The 3 3V voltage is provided from the 3 6 V by dropping the voltage as required in D23 5 V voltage The 5 V supply voltage is provided from the cell voltage by means of chopping regulator U29 and free wheel diode D30 The network made up of Q27 D24 D26 and C157 operates like a switching aid raising the voltage The components make up a regulator working in the step down mode Control is provided by dividing bridge R47 R236 Backlighting voltage The supply voltage of the backlighting is provided from the 5 V voltage through chopping regulator U38 It provides a chopped volume with an approximate amplitude of 190V The chopping frequency 260HZ is regulated by R308 Vee voltage The Vee supply voltage is provided from the 5 V by means of chopping regulator U30 chopping transistor Q28 induction coil L8 diode D28 and limiting resistors R241 R242 The current is controlled by R243 in series with R244 in parallel with C151 The assembly makes up a regulator operating in the inverter step up mode 5V voltage The 5 V voltage is provided from Vee by means of a linear regulator Power supply by the Mini DIN 7 connector The device can be powered by an external power source through the Mini DIN 7 connector that is located in a rec
42. 4A and U24B is also generated by the 10 Hz signal through D32 R13 and C102 Part no 0 48 0029 5 30 May 2003 Technical description of boards Patient impedance measurement Patient impedance is measured by an oscillator which injects a 22KHz sinus current towards the patient through networks R254 R252 C152 C154 R248 and R255 R253 C151 C155 R249 The sinus oscillator is made up of U26A and U26B While testing the ECG signal acquisition chain the sinus oscillator is blocked by means of transistor Q24 The sinus oscillator is protected from possible transients by means of sparker E1 and clipping diodes DZ32 and DZ33 Patient impedance is measured by processing the amplitude of the 22KHz signal contained in the ECG signal The 22KHz signal is extracted through cells C81 R211 and C82 R212 which are attacked by voltage followers U21A and U21B Stage U21C makes up a differential amplifier with a gain value of 10 The 22KHz sinus signal is amplified once again with gain of 9 through U21D and associated components The following stage is made up of a peak rectifier built around 23A et D22 The output signal of this stage is integrated by R45 and C95 in order to supply continuous voltage where the amplitude depends on the patient impedance value Circuits U23B and 38B make up an additional gain stage with a limit adjustment below the patient impedance by means of VR2 The output signal from this stage is buffered by U38A to make up signal Z_ELEC_DE
43. BAT_SWITHED Q29 amp Q30 simulate a low forward voltage diode A Q 3 3V 3 6V 5V 5V VEE 3 3V B_D 16 31 CJ RTC_WATCHDOG BA O 7 Microcontroller Process Unit B_D 16 31 gt COLDFIRE CS3 OE WE RTC_WATCHDOG PUSH_BUTTON_POWER_ON CMD_FLASHING_LED_ON rm PUSH_BUTTON_POWER_ON GND O ONOFF_ANALYSE_KEY ONOFF ANALYSE KEY CMD_FLASHING_LED_ON lt _ E T N AA GND lt t t LED ANALYSE MEMORISATION om 3 PUSH_BUTTON_CHOC GND O CHOC_KEY CHOC KEY CMD_FLASHING_LED_ON INH AA a E E Supervisory Circuit amp Delayed Reset LED CHOC nie a INH1 Sheet 10 20 CMD_LED_ANALYSE PUSH_BUTTON_CHOC CMD_LED_CHOC RTC_PF_RESET RTC_PF_RESET Start Stop Power Supplies Schema No WSM0005_SYN2 SCHILLER Project 01 58 E 09 Size A3 Drawn by JME NF PCB No WSM0005_PCB2 Art No WSMO0005A MEDICAL 8 A 4 rue Louis Pasteur ZAE Sud BP50 67162 WISSEMBOURG CEDEX Date 08 01 03 Sheet 4 of 9 Technical description of boards Buzzer Alarm The buzzer alarm is activated when an error is found during the self test phase Note The Buzzer alarm is heard as a sequence of two consecutive beeps that are repeated after every two seconds The Buzzer alarm function is powered by UBAT through protection resistors R343 and R344 The buzzer alarm is sta
44. D fibrillateur INH_PACE BACK 006HZ 10HZ ECG DEFI Z HEC DEFI ECG LB DELTA Z FoR PREAMPLI ECG INH PACE BACK 00SHZ 16 TOHZ 18 Bp ECG DEH S Z ELEC DEH ao FOG LB PAA DELTA Z 1 UBATT 2 4 6 BO 33V 100 5v 270 V 12 21 2 31 32 3 EHVG AO 260 NC WORA BATT NC LHVG 5o HATERC EPDU SDA 7 UPRA go SS PIOR SHOCK KEY ECGRA CIRCUIT DE COMMANDE DEFIBRILLATEUR 14 TYPE ELEC 30 INHIBITION 13 ONOFF ANALYSE KEY SHOCK KEY 110 RST DEH Pe TXD DER 19 RXD DEH 10 gt UBATT 20 gt 33 a Connecteur 30 44 Pile Lithium 40 SDA 5 BATT NC EHVG WDRA LHVC UPRA sock HEY ECGRA EPDU CIRCUIT HAUTE TENSION DU CIRCUIT DE DETECTION REDU DE DEFAUT APEX Connecteur Electrodes STERNUM Synoptique Fred Easy Defibrillator Re u 58 FRED EASY DEFI Date 21 01 03 Art No WVSVO008A Sheet 1 of 1 Project S A3 SCHILLER MEDICAL B A 4 rue Louis Pasteur ZAE Sud BP50 67162 WISSEMBOURG CEDEX Device modifications 6 Device modifications 6 1 Definition ECL The ECL is the three digit PNN revision number of the board P is the version number of the board and is incremented with each rerouting operation NN is incremented with each modification made to
45. Etiquette N s rie F ce TR1 violet JPE JPE HERE R1 Blanc white
46. FI transmitted to the CPU board Before voltage follower U38A the analogue signal corresponding to the patient impedance attacks a window comparator U25A and U25B which generates the PIOR signal Signal PIOR is used by the defibrillator control circuit in order to check if the defibrillation electrodes are glued correctly Defibrillator control circuit The defibrillator control circuit part performs the following functions e Self test of the defibrillator part Transfer of information by serial link with the CPU board Driving the high voltage capacitor charge Measuring the energy stored in the high voltage capacitor Triggering the defibrillation shock if the Shock key is pressed Determining patient resistance during defibrillation shocks Driving the patient impedance compensated pulse biphasic waveform Safety discharge of the high voltage capacitor General description of the defibrillator control circuit The defibrillator control circuit contains a microcontroller that performs all the functions described above When the device is switched on the defibrillator control circuit performs the self test of the defibrillator part The defibrillator control circuit microcontroller exchanges information with the CPU board via a serial link During the SAD protocol the defibrillator control circuit checks if the Analyse key is pressed signal ONOFF_ANALYSE_KET and transmits the corresponding signal by means of the serial link of the CPU board
47. Fire processor through signals SPl_CS3 QSPICLK SPI_DATA IN and SPI DATA OUT Signals DET_ PRESENT _SDCARD and SDC_WRITE_PROTECTED are status signals of the memory card which indicate the presence and write protection of the MMcard respectively The signals are active in the low logical state The lines connected with JP5 are all protected by resistors of 22 1 Q The power supply of the MMcard is protected by fuse F2 CPU hardware configuration The hardware configuration is performed through the input latch U41 The first seven inputs of the latch can be forced to a low or high logical status that depends on the installation of appropriate resistors Note The eighth input is occupied by signal SDC_WRITE_PROTECTED and cannot be used for hardware configuration Input latch U41 is under the control of ColdFire through data bus B_D 24 31 and signals CS1 and OE via gate OR of U40A Control signal LCD_ENAB input 11 of U41 is generated by latch U42 see section AFFICHAGE_LCD Part no 0 48 0029 5 15 May 2003 Serial Communication between CPU and MMC DET_PRESENT_SDCARD SPI_CS3 SPI_DATA_ OUT QSPICLK SPI_DATA_IN SDC_WRITE_PROTECTED Configuration Bits K gt B_D 16_31 Hardware LCD Interface Serial Communication between CPU and MMC Project 01 58 E 09 PCB No WSM0005_PCB2 Size A4 Drawn by JME NF Art No WSMO005A
48. G analysis automatically Note With the signals from the AHA American Heart Association database the detection accuracy of FRED easy was found to be 98 43 sensitivity with a specificity rate of 99 80 The device may be configured so that it automatically starts the ECG analysis If the analysis program recognises a heart rate that calls for defibrillation it automatically charges the energy required for defibrillation and asks the user to deliver the shock after the energy is charged The following are considered to warrant defibrillation ventricular fibrillation or ventricular tachycardia with a heart rate of over 180 bpm Part no 0 48 0029 Page 1 3 May 2003 Operation If the device finds a heart rate that calls for defibrillation defibrillation is only authorised if the patient is found to have no pulse or if there are no signs of circulation If the defibrillation shock has no effect the device automatically charges the energy required for a second or even a third shock Note The energy values are set by default as follows the technical assistance of SCHILLER can configure other default values if needed Shock Adult Child 1 90 J 15J 2 130 J 30 J 3 150 J 50 J If the third shock is also ineffective the FRED easy device asks to user to alternately administer artificial respiration and heart massage After a minute an ECG analysis will be requested once again Depending on the
49. If VF VT is recognised by the master microprocessor of the CPU board the board sends a pre charge request and the energy selected by the serial link Before setting off the high voltage capacitor charge the defibrillator control circuit microcontroller checks the operating of the charging transistor by signal CTFC When the test is completed the defibrillator control circuit generates the charging transistor activation signal signal EHVG The safety discharge relay is also excited by means of signal WDRA When the different operations are completed the high voltage capacitor charge is triggered by activating the high voltage generator signal LHVC During the charging of the high voltage capacitor the microcontroller measures the energy stored in the high voltage capacitor through signal THVM The microcontroller also generates two IGBT blocking signals signals PPG1 and PPG2 When the stored energy is equal to the selected energy the microcontroller stops the high voltage generator and the defibrillator circuit is in the stage when preliminary charging is completed and defibrillation is not allowed During the phase when preliminary charging is completed the microcontroller measures the energy stored in the high voltage capacitor by means of signal CHVM If during the previous charging phase the analysis of the ECG signal by the CPU board confirms VF VT the CPU board sends a new charging request to the defibrillator circuit The defibrillator co
50. Lithium battery capacity 200 shocks at the maximum power rating or Use of the monitor for seven hours cyclical 30 minutes on 30 minutes off Five years standing by Environment conditions Transport storage Temperature 30 to 50 C Relative humidity of air 0 to 95 non condensing Atmospheric pressure 500 1060 hPa Use Temperature 30 to 50 C Relative humidity of air 0 to 95 non condensing Atmospheric pressure 700 1060 hPa Electromagnetic compatibility The FRED easy device only uses radio frequency range energy for its internal functions It is treated against interference in accordance with standard CISPR 11 class B The FRED easy device can be subjected to the following interference without any adverse effect on its functioning electrostatic discharges of up to 8 kV energy in the radio frequency range up to 20 V m 80 2500 MHz 5 Hz modulated magnetic fields of 100 A m 50 Hz Dimensions and weight Width 220 mm Depth 230 mm Height 70mm Approximate weight 1 5 kg with battery Part no 0 48 0029 Page 1 8 May 2003 Testing and maintenance 2 Testing and maintenance This section describes the testing and maintenance procedures recommended for FRED easy 2 1 Functional testing The device runs an automatic functional test In order to ensure proper performance tests are performed when the device starts in the nominal mode SAD mode once
51. MIKE_GSM_PLUS K MIKE_GSM_MINUS Sheel 19 20 Form Electret Microphone SPEECH _GSM_PLUS K_SPEECH_GSM_MINUS Telephone GSM Option Encoding Decoding ADPCM Audio Amplification Project 01 58 E 09 PCB No WSM0005_PCB2 Size A3 Drawn by CF NF Art No WSMO005A Schema No WSMO005_SYN2 Date 09 01 03 Sheet 9 of 9 SCHILLER MEDICAL B A 4 rue Louis Pasteur ZAE Sud BP50 67162 WISSEMBOURG CEDEX Technical description of boards Recognition of the type of electrode The type of electrode used child or adult is recognised by a reed type contact REL1 The child electrode connector has a magnet that draws contact REL1 and forces signal TYPE_ELECTR to the low logical status The signal is transmitted to the defibrillator microcontroller Note The adult electrode connector does not have a permanent magnet EMC measurements The CPU circuitry is enclosed in a metal housing that is connected at several locations to the CAVE ground plane that acts as the reference for EMC filtering The CAVE ground plane occupies the outer layer of the CPU board and therefore forms an enclosure with the metal housing All the input and output CPU signals are filtered by networks RC and LC GSM interface The GSM interface is optional The link between the CPU and the GSM interface is provided by a flat jumper via connector JP6 The GSM
52. N 47 1 58 0402 35 2 HV CONTACT BOLT 6 14 0000 34 2 HV MALE CONTACT 2mm 35041 32 EMORY BATTERY 4 07 0000 22 5 LED AMBER SQUARE FORM 4 58 0002 21 LOUD SPEAKER CABLES PROTECTION 1 58 040 20 LOUD SPEAKER CABLES PROTECTION 1 58 040 17 LCD GSM SUPPORT 6 90 0002 16 2 ON OFF OR ANALYSE SWITCH 4 54 000 15 14 L SPACER CPU DEFI BOARD 6 13 0000 13 2 CAPACITOR SUPPORT 6 99 000 12 SHOCK KNOB CAP 6 03 000 6 ON OFF KNOB CAP 6 03 0000 5 LCD SUPPORT 1 58 0403 3 DEFI BARD WITHOUT CAPACITOR SUPPORT WSMO008A 2 UPPER CASE 1 58 0100 1 DOWN CASE 1 58 0404 ITEM QTY JDESIGANTION PART NUMBER spare list Technical description of boards 5 Technical description of boards 5 1 FRED easy General description of FRED easy FRED easy is technically divided into two subassemblies including The DEFI board includes the various digital processing functions specific to the defibrillator the analogue processing functions and the high voltage circuit of the defibrillator The CPU board includes the various functions relating to digital processing analogue processing data saving additional power supplies and controls and displays The two boards communicate electrically between each other through a 32 pin connector JP 4 Controls power supply display and recording The various controls and display elements of the CPU board are as follows An LCD screen that acts as the visual interface between FRED easy and the user A dual fu
53. SCHILLER MEDICAL S A S FRED easy Semiautomatic defibrillator PAD Service Manual Version 01 00 SCHILLER TH ART OF DIAGNOSTICS Part No 0 48 0029 FRED EASY Revision history of the service manual Version 01 00 May 2003 Part no 0 48 0029 Page May 2003 FRED EASY WARNING This manual shall be considered to form an integral part of the device described This technical manual is intended for qualified personnel and describes the operating maintenance and troubleshooting procedures for FRED EASY Compliance with its content is a prerequisite for proper device performance and for the safety of the patient and operator The manufacturer shall only be liable for the safety reliability and performance of the device if assembly extensions adjustments modifications or repairs are performed by the manufacturer or by persons authorised by the manufacturer the electrical installation of the facility of use complies with the requirements applicable in the country the device is used in accordance with its instructions for use the spare parts used are original parts from SCHILLER This manual describes the device at the time of printing The supply of this manual does not in any event constitute permission or approval to modify or repair a device The manufacturer agrees to supply all the spare parts for a period of ten years All rights reserved for the devices circuits processes a
54. STOR ERROR Message DEFIBRILLATOR SAFETY DISCHARGE ERROR Message DEFIBRILLATOR EPROM ERROR Message DEFIBRILLATOR SHOCK BUTTON ERROR Message DEFIBRILLATOR COMMUNICATION ERROR Message SYSTEM ERROR Fault detected during the self test Monitor on but the OK LED does not flash Part no 0 48 0029 Troubleshooting DEFI board 1 1 1 DEFI board CPU board 1 1 CPU board DEFI board DEFI board CPU board 2 DEFI board 1 CPU board 1 CPU board Page 3 2 Replace DEFI board Replace DEFI board Replace DEFI board Replace DEFI board Replace DEFI board Replace DEFI board Replace CPU board Replace CPU board Replace DEFI board Replace CPU board 2 Replace DEFI board Replace CPU board Replace CPU board May 2003 Cell symbol flashing but no remaining Electrodes not connected and LED under electrode connection off Electrodes connected to simulator with 50 ohm impedance but the LED does not go off No cell voice message Device off OK LED off and no buzzer Audio alarm Green Analysis key or orange Shock key not on Abnormal internal discharge No shock delivered No record on memory card Loss of date and time Part no 0 48 0029 Troubleshooting 1 Cell contact fault DEFI board faulty CPU board faulty DEFI board faulty CPU board faulty Speaker fault CPU board fault Buzzer fault CPU boa
55. a week and each time a battery is inserted The Test mode defines specific device behaviour and is used to test its vital functions The functioning of the Test mode is not redundant with the self test phase The aim of the self test is to check the vital functions of the device when it is switched on The aim of the Test mode is to regularly check the vital parts of the device in order to ensure that it will continue to perform even when it is used occasionally The device is also in the Test mode when a battery is inserted In that case specific tests are defined Specific case of self tests Self tests are performed automatically when the device is switched on and require no action by the operator No message describing the test under way is displayed when the device runs its self tests A message is displayed to merely show that the device is about to start STARTING The software version of the device is also displayed during the self test The self test consists in checking the following functions e ADC converter test it is used to validate the functioning of the analogue to digital converter used to acquire battery parameters voltage and temperature and patient parameters ECG 250Hz MVTS impedance variation patient impedance e Defibrillator test level 1 used to validate the status of the defibrillator hardware and particularly to ensure that communication with the defibrillator is operational and that the defibril
56. arging of the high voltage capacitor preliminary charging and charging In both cases the charging of the high voltage capacitor is identical The difference lies in the status of the defibrillator when charging is completed If the high voltage capacitor is charged following a preliminary charge signal the defibrillator enters the preliminary charge completed mode when the charging is done During that stage the defibrillator stands by for a new charging request and does not allow the delivery of defibrillation shocks If the high voltage capacitor is charged following a charge signal the defibrillator enters the hold phase when the charging is done During the hold phase the defibrillator allows the delivery of defibrillation shocks To set off the charge or preliminary charge the master microprocessor of the CPU board also sends a signal corresponding to the selected energy When the preliminary charge signal is received with the selected energy level microcontroller U36 checks the charge transistor by means of signal CTFC After verifying signal CTFC microcontroller U36 activates charge transistor Q1 of the high voltage circuit through signal EHVG and open collector driver U33A The activation of Q1 generates the power supply voltage of the high voltage generator UCHARGE The voltage is that of the lithium cell protected by F1 and switched by Q1 Microcontroller U36 also activates signal WDRA which excites safety discharge relay RL4 through
57. brillator is in the preliminary charge completed phase standing by for a new charging request During the preliminary charge completed phase microcontroller U36 calculates the energy stored in the HV capacitor through signal CHVM The maximum duration of the preliminary charge completed phase is set to 15 s Beyond that time microcontroller U36 triggers the safety discharge of the HV capacitor by deactivating all its outputs If during the preliminary charge completed phase U36 receives a new charge request with a selected energy value the microcontroller goes back to the charging phase by activating signal LHVC Charging phase set off by charge information When signal LHVC becomes active once again capacitor charging is restarted and the energy stored is calculated as before through signal THVM When the energy stored is equal to the energy defined by the master microprocessor of the CPU board microcontroller U36 deactivates signal LHVC which stops the HV capacitor charge In those conditions after a delay of 50ms the defibrillator switches to the hold phase The charging phase initiated by a Charge signal lasts no more than 30s Hold phase When the defibrillator enters the hold phase microcontroller U36 determines the energy stored in the HV capacitor through signal CHVM and checks if it is located within the authorised tolerances It that is not so U36 leads to a safety discharge of the HV capacitor During the hold phase microcon
58. buffer U34A and transistor Q5A After a delay of 50ms microcontroller U36 activates the high voltage generator through signal LHVC and buffer U34B When all the conditions are met the charging of the high voltage capacitor can start The maximum duration of the charge initiated by the preliminary charge signal is 20s after which U36 triggers a safety discharge of the high voltage capacitor by deactivating all the active outputs In order to actively block the IGBTs of the HV switching circuit microcontroller U36 also generates two signals PPG1 and PPG2 with a period of 16ms and a width of 200us Through gates U17A and U17D drivers U5B and U7B and transistors Q13 and Q16 the two signals PPG1 and PPG2 trigger the generation of blocking pulses in the cores that drive the gates of the IGBTs Microcontroller U36 generates the IGBT blocking pulses during the charging preliminary charging completed and hold phases During the charging of the HV capacitor initiated by the preliminary charge control microcontroller U36 measures the charging voltage of the HV capacitor through signal THVM via multiplexer U31 The energy stored by the HV capacitor is calculated by U36 When the value is equal to the energy defined by the master Part no 0 48 0029 5 33 May 2003 Technical description of boards microprocessor of the CPU board U36 deactivates signal LHVC which stops the charging of the HV capacitor Preliminary charge completed phase The defi
59. compensated biphasic waveform is generated by means of signals FPIC and SPIC The two signals control the primary current of the control cores of the IGBTs by means of drivers U5A and U7A and transistors Q14 and Q15 The primary current of the cores is limited by resistors R200 R201 and R202 When the cores are controlled by transistors Q14 and Q15 the secondary windings generate positive gate voltage that makes the IGBTs of phase 1 or phase 2 conduct depending on signals FPIC and SPIC The patient compensated pulse biphasic waveform defibrillation shock is provided by IGBTs Q7 to Q12 which form an H bridge The first phase of the biphasic waveform is achieved by making Q7 and Q12 conduct The second phase is achieved by making Q9 Q10 and Q8 Q11 conduct The IGBT high voltage switching circuit is connected to the patient by means of the patient relay made up of RL5 and RL6 The patient relay is controlled by the two signals UPRA and SHOCK_KEY The first signal UPRA that controls transistor Q6B is generated by microcontroller U36 of the defibrillator control circuit The UPRA signal has a duration of 100ms The second signal SHOCK_KEY is derived directly from the Shock key of FRED easy Signal SHOCK_KEY activates transistor Q3 which saturates Q6A through network D6 C62 and R63 When the two transistors Q6A and Q6B conduct and the defibrillator is in the hold phase the patient relay is activated for a duration of 100ms The defibrillation shock is autho
60. completed and hold phases Signal PPG2 has a period of 16ms The current pulses in the cores have a duration of 100us Signal PPG2 is offset by 8ms in relation to PPG1 gt signal PPG2 is active when low active at OV SFDU Set Failure Detection Unit Logical signal from microcontroller U36 that triggers the safety latch when the device is switched on before the latch is tested by the microcontroller Signal SFDU is active for 5ms gt input signal SFDU is active when low active at OV RFDU Reset Failure Detection Unit Logical signal that direct resets the safety latch after it is tested when the device is switched on Signal RFDU is active for 5ms gt input signal RFDU is active when low active at OV Part no 0 48 0029 5 47 May 2003 Technical description of boards 5 3 6 High voltage circuit Input signals of the high voltage circuit EHVG Enable High Voltage Generator Logical signal that powers the high voltage unit When the signal is active it activates the charge transistor in order to enable an HV capacitor charge request or a battery test gt input signal EHVG is active when high active at 5 V WDRA Energy Dump Relay Activation Logical signal that activates the safety discharge of the high voltage unit through a transistor The signal is active during the entire defibrillation cycle During battery tests signal WDRA is not active gt input signal WDRA is active when high active at 5 V
61. configuration the new analysis may be automatic After a successful defibrillation shock the FRED easy device asks the user to check the patient s breathing and blood circulation If there is no sign of circulation the device asks the user to alternately administer artificial respiration and heart massage If there is any sign of circulation the patient must be laid on his or her side If the analysis program does not recognise a heart rate calling for defibrillation FRED easy informs the user that defibrillation is not necessary and asks the user to look for breathing and signs of circulation If there is no sign of circulation the FRED easy device asks the user to alternately administer artificial respiration and heart massage If there are any signs of circulation the user is asked to lay the patient on his or her side After a minute the FRED easy device repeats the request for an ECG analysis Depending on the configuration the new analysis may be automatic The following values can be configured by the technical assistance department of SCHILLER upon starting up introductory text or immediate request to apply the adhesive electrodes voice volume energy levels of shocks 1 2 and 3 with adult and child separate starting of the ECG analysis via the keypad or automatically Part no 0 48 0029 Page 1 4 May 2003 Operation Procedure chart Check for signs of circulation If no signs of circulation rescue
62. ctivated gt input signal ECGRA is active when high active at 5 V or 14V max FPIC First Phase IGBT Conducting Logical signal makes the phase 1 IGBTs conduct during the defibrillation shock This signal matches the content of the EPROM for the selected bank gt signal FPIC is active when high active at 5 V Part no 0 48 0029 5 48 May 2003 Technical description of boards FPIB First Phase IGBT Conducting Logical signal that makes the phase 1 IGBTs block during the charge preliminary charge completed and hold phases and during the defibrillation shock This signal is either signal PPG1 or the content of the EPROM for the bank selected during the shock gt signal FPIB is active when high active at 5 V SPIC Second Phase IGBT Conducting Logical signal makes the phase 2 IGBTs conduct during the defibrillation shock This signal matches the content of the EPROM for the selected bank gt signal SPIC is active when high active at 5 V SPIB Second Phase IGBT Conducting Logical signal that makes the phase 2 IGBTs block during the charge preliminary charge completed and hold phases and during the defibrillation shock This signal is either signal PPG2 or the content of the EPROM for the bank selected during the shock gt signal SPIB is active when high active at 5 V Output signals of the high voltage circuit CHVM Capacitor High Voltage Measurement Analogue signal offering the second way
63. d PPG2 generate signals FPIB and SPIB by means of gates U17A and U17D These signals control the IGBT blocking pulses by means of U5B U7B Q13 and Q16 see above During the charging preliminary charge completed and hold phases the pulsed biphasic waveform control circuit U15 and U16 is disabled by signal UPRA which is high IGBT control during the defibrillation shock During the defibrillation shock the IGBT control signals of the HV switching stage are directly generated by counter U15 and memory U16 activated by signal UPRA when it is low The data contained in the various banks sent by microcontroller U36 through signals PBSBO PBSB1 and PBSB2 depending on the patient resistance control the active blocking and conduction of the IGBTs during the defibrillation shock Signal FPIC makes the IGBT of the first phase Q7 and Q12 conduct The IGBTs are blocked by signal FPIB Signal SPIC makes the IGBTs of the second phase Q9 Q10 and Q8 Q11 conduct The IGBTs are blocked by signal FPIB Fault detection circuit Part no 0 48 0029 5 38 May 2003 Technical description of boards The fault detection circuit part performs the following functions e Detection of hardware faults in the critical components of the defibrillator General description The fault detection circuit monitors the critical fault conditions that may be generated by a technical fault of the defibrillator part When the FRED Easy device is started up the defibrillat
64. ds Configuration EEPROM Configuration EEPROM U26 is under the control of the ColdFire processor through a synchronous serial link Line SCL carries clock data and the SDA line carries bi directional data Communication between the ColdFire microprocessor and the defibrillator Communication between the ColdFire processor and the defibrillator is provided by a 9600 baud RS232 serial link Signal TXD_DEFI from the defibrillator microcontroller is directly applied to the entry of the ColdFire microprocessor Signal RXD_DEFI generated by the ColdFire processor is transmitted to the microcontroller of the defibrillator through a voltage level adaptation stage The stage is build around Q1 and Q2 Part no 0 48 0029 5 7 May 2003 Serial Communication RS232 Bus and I2C Bus EEPROM Config U26 EEPROM Batte lt A lt a AS Teo Ge tie COLDFIRE DEFIBRILLATOR ae RST_DEFI RST_DEFI DO DEF TXD DEF INHIBITION 7 INHIBITION ry ry A i RXD_GSM i TXD_GSM i 45 mo mess I I I I a ei a arrar errr Spy On RXD_DEFI P8 To PC Rx and SPy On RXD_GSM 1 lt Spy On TXD_GSM MUX ee i tee E E Tx from PC Tx from PC INHIBITION i j Telephone GSM TXD_GSM from PC 1 RD GSW MINIDIN7 a lt TOME R62 R233 i Sheet 13 20 212V E L__ gt GND Sheet 19 20 Ext
65. e Level 2 hardware test of the defibrillator module test of a battery test command by the defibrillator module This test is used to check that the power source of the device lithium cell or battery makes it possible to charge the device e ECG acquisition circuit test checking the functioning of the ECG signal acquisition chain which acts as the basis for analysing the patient s heart signal This test is used to make sure that the data on which the diagnostic is based are consistent The tests are performed automatically from time to time Every week at 12 00 hours the tests are performed if the device is off The clock wakes the device for the requisite operations The alarm date is configurable by means of the configuration PC Periodic tests are logged in order to be able to determine the nature of any failure and the time when the failure occurred The last thirty results of periodic testing are logged in the memory The memory can be read simply by means of a PC in the configuration and transfer mode That makes it possible to identify the origin of the problem found The logged data include the following e test date test time test result origin of the problem found if the result shows an error The detection of a problem during a periodic test makes the device impossible to use The Status display is changed in order to indicate that a problem has been found Nothing is displayed during the periodic tests in order to ma
66. e On Off key Start of an analysis Delivery of a defibrillation shock 3 3 V voltage supervisor Time stamping Buzzer alarm Status LED indicator MMcard interface CPU hardware configuration LCD display interface AD converter Analogue processing of the ECG signal Monitoring of the internal temperature of the device Supervision of the power supply cell voltage Supervision of the backup cell voltage ADPCM decoder for voice message emission Audio amplifier for voice message emission ADPCM encoder for recording the environment sounds Generation of intermediate clocks Recognition of the type of electrode child adult EMC measurements Optional functions GSM telephone Development debugging and miscellaneous utilities Serial link to list to communication between the ColdFire processor and the defibrillator microcontroller Ethernet link Part no 0 48 0029 5 3 May 2003 Technical description of boards Data bus amplification The ColdFire data bus has bi directional amplification through U28 With the exception of DRAM U7 and U39 all the other peripherals use the amplified data bus B_D 16 31 Signal WE generated by ColdFire controls the direction of data transmission and signal BD_CS generated by programmable circuit U2 of the intermediate clock generation function controls the activation of U28 Address bus amplification The address bus of the ColdFire processor has unidirectional amplification through U25 Only th
67. e device is switched on the ECG relay must be activated in order to transmit the patient ECG signal to the ECG preamplifier During the defibrillation shock the ECG relay control deactivates the coil for 100ms in order to insulate the ECG preamplifier part from the high voltage circuit when the patient relay is activated gt input signal ECGRA is active when high active at 5 V or 14V max PBSBO Patient Bank Selection Bit 0 First of the three encoded bits used to select the different EPROM banks depending on the calculated patient impedance gt signal PBSBO is active when high active at 5 V PBSB1 Patient Bank Selection Bit 1 Second of the three encoded bits used to select the different EPROM banks depending on the calculated patient impedance gt signal PBSB1 is active when high active at 5 V PBSB2 Patient Bank Selection Bit 2 Third of the three encoded bits used to select the different EPROM banks depending on the calculated patient impedance gt signal PBSB2 is active when high active at 5 V PPG1 Prepulse Generator Logical signal that blocks the IGBTs through cores during the charging preliminary charge completed and hold phases Signal PPG1 has a period of 16ms The current pulses in the cores have a duration of 100us gt signal PPG1 is active when low active at OV PPG2 Prepulse Generator Logical signal that blocks the IGBTs through cores during the charging preliminary charge
68. e eight low addresses A 0 7 are amplified With the exception of DRAM U7 and U339 all the other peripherals addressed use the amplified address bus BA 0 7 Part no 0 48 0029 5 4 May 2003 FLASH MEMORY B_D 16 31 lt 4 Microcontroler Process Unit BSI0 3 C CLK4M096 CS decoder GAL22LV10 BDCS CS 0 7 C Secondary Clock Generator GAL22LV10 Binary Counter CLK20M48 CLK4M096 FST_INHIB lt CLK20M48 CPU_CLK ADPCM Encoder control signals GAL22LV10 Binary Counter BCLKT lt BCLKT SYNC _FST SYNC_FST sheet 6 20 BS 0 3 A10PRECH SDCLK SDCLKE RSTO WE FLASH_BUSY OE CS0 K FST_INHIB CPU_CLK Microcontroler Process unit Project 01 58 E 09 Drawn by JME NF BUFFER Schema No WSM0005_SYN2 Date 08 01 03 Sheet 2 of 9 PCB No WSM0005_PCB2 Art No WSMO005A SCHILLER _ MEDICAL B A 4 rue Louis Pasteur ZAE Sud BP50 67162 WISSEMBOURG CEDEX Technical description of boards Power supplies 3 6 V voltage The 3 6 V power supply voltage is supplied from the cell voltage by means of chopping regulator U22 chopping transistors U20 U21 free wheel diode D29 and current limiting resistor R220 All these components form a step down regulator Voltage control is provided by divider bridge R221 and R
69. e of the HV capacitor divided by 850 The second circuit for measuring the HV capacitor charge voltage only generates a signal during the HV capacitor charge phases The measurement signal is taken through the primary winding of the HV transformer TR1 which reflects the charge voltage of the HV capacitor when transistor Q4 is blocked The signal of the primary winding of TR1 is taken by transistor Q2 and the associated components Stages U1A and U1B make up the circuits that form the signal supplied by Q2 The output signal from U1B THVM is also the HV capacitor charge voltage divided by 850 Signal THVM is used by microcontroller U36 to measure the HV capacitor charge voltage in order to stop the HV generator charge Charge stopping is adjusted by means of VR1 HV switching circuit blocking During the charging preliminary charging completed and hold phases the microcontroller generates two signals PPG1 and PPG2 which lead to the active blocking of IGBTs Q7 Q8 Q9 Q10 Q11 and Q12 of the HV switching circuit The IGBTs are blocked by signals FPIB and SPIB which control the primary current of the IGBT control cores L1 L2 L3 L4 L5 and L6 by means of drivers U5B and U7B and transistors Q13 and Q16 While the cores are controlled by transistors Q13 and Q16 the secondary windings generate a negative gate voltage that blocks the IGBTs of both phases Generation of the patient impedance compensated biphasic waveform The patient impedance
70. e test the device finds an error itissues an audio alarm the green indicator does not flash The alarm signal rings till the battery is completely discharged Key T is used to repeat the self test and the error message is displayed Also the device runs a self test after every seven days The test is announced by a beep If during the test the device finds an error itissues an audio alarm the green indicator does not flash If you press key D the corresponding error message is displayed In that case you must replace the battery and repeat the test Depending on the test result the error message will disappear or another message will be displayed 1 4 Defibrillation procedure All the stages are explained orally to the user at the same time as they are displayed on the screen Once key D is pressed the introductory text tells the user what is to be done if the patient has the following symptoms the patient has ceased to breathe there is no sign of circulation The introductory text is repeated till the FRED easy device recognises the application of the adhesive electrodes Depending on the configuration the introductory text may be deleted and the device directly requests the application of the adhesive electrodes After that the FRED easy device asks the user to start an ECG analysis and to no longer touch the patient The analysis lasts approximately 10 s Depending on the configuration the device starts the EC
71. eak patient peak current Part no 0 48 0029 5 49 May 2003 Technical description of boards CTFC Charge Transistor Fault Condition Analogue signal to detect any short circuit in the charge transistor that charges the high voltage unit The transistor is considered to fail when signal CTFC is greater than 1 0V before the HV capacitor charge starts gt signal CTFC must be located between 0 and 5 V at the most DUFD Discharge Unit Failure Detection Analogue signal that corresponds to the mid point of the two patient relay activation transistors Signal DUFD must lead to the triggering of the safety latch when one of the relay activation transistors must conduct for over 2 5 s That also makes it possible to detect a short circuit in any of the two transistors or in both gt input signal DUFD is located between 0 and UBATT at the most IGFD IGBT Failure Detection Analogue signal that is equal to the differential potential between the mid points of the two branches of the H bridge The signal is amplified and its amplitude is compared to a reference limit Signal IGFD must lead to the triggering of the safety latch when the IGBTs of a branch of the H bridge is needed to conduct for over 1 5s That also makes it possible to detect any IGBT short circuit in the HV switching stage gt Signal IGFD is active when low active at 0 V ECG1 ECG signal from the Defi connector ECG signal from the Defi connector transmitted by
72. er all the circuits of the ECG preamplifier ECG signal acquisition The ECG signal taken by means of adhesive defibrillation electrodes is acquired through following stages U37 and the resistor networks made up of R251 R259 R294 and R250 R260 R295 The ECG preamplifier input stage is protected from possible transients by sparker E2 and clipping diodes D24 and D25 The clipping diodes are polarised to the reference voltages of 2 5 V and 2 5 V generated by voltage references U9 and U10 Amplification and processing of the ECG signal The two circuits U22A and U22C make up a differential amplifier with a gain value of 4 Capacitor C79 is used to attenuate the amplitude of the 22KHZ sinus signal used to measure patient impedance The two stages U22B and U22D make up an amplifier with a gain of approximately 43 where the direct component is compensated by means of elements R244 and C96 If a pacemaker pulse is detected by the master microprocessor of the CPU board analogue switch U24D is opened by signal INH_PACE in order to limit direct component overrun Signal ECG_DEFI sent to the CPU board makes up the output signal of the stage The output signal from U22D corresponding to the amplitude of the direct component of the ECG signal is compared to reference limits by window comparator U4 If the polarisation voltage of the ECG signal is too great window comparator U4 blocks transistor Q17 which activates analogue switch U24C The activation of
73. er use phenol based cleaners or cleaners containing peroxide derivatives to disinfect the surfaces of the housing of the device e Dispose of all single use electrodes immediately after use in order to eliminate the risk of accidental reuse disposal with hospital waste e Before cleaning the electrode cables of sensors disconnect them from the device For cleaning and disinfecting wipe the cables with a gauze cloth moistened with cleaner or disinfectant Never immerse the connectors in liquid The cleaning solution used may be any cleaning or disinfecting solution that is commonly used in hospitals e Proceed likewise with the device housing with a cloth moistened with cleaner or disinfectant No liquid may be allowed to penetrate into the device during the operation Part no 0 48 0029 Page 2 3 May 2003 Troubleshooting 3 Troubleshooting This section addresses the troubleshooting procedures for FRED easy If you have trouble locating or correcting the problem contact the after sales service department of Schiller Precautions during troubleshooting While testing the FRED EASY defibrillator the patient may only be simulated with fixed high voltage and high power resistors that are well insulated from the ground or earth Poorly insulated devices or devices with loose contacts or devices containing components such as spark arresters or electronic flash lamps may never be used as they could irremediably destroy the device The use
74. ering for extracting the PACE information Signal ECG_DEFI is applied to analogue switch U45 which is responsible for opening the amplification circuit when a stimulation pulse is detected The opening is commanded by signal INHIB_PACE At the output of the switch the signal is applied to follower U46 through a capacitive link made up of R33 and C53 the role of which is to eliminate the continuous component of signal ECG_DEFI Final amplification and filtering is performed by U32C Through the divider bridge made up of R86 R223 and R245 circuit U32C brings the dynamics of signal ECG_ADC to the middle of the ADC conversion range The PACE information is extracted from signal ECG_DEFI through the amplification and filtering circuit built around U32A U32C and U32D The output of the amplification and filtering circuit is applied to comparators U34A and U34B which control the triggering of monostable U33A and U33B At the monostable output D14 D15 and R66 form an AND gate through which stimulation pulse recognition DETECT_PACE is transmitted to ColdFire In response the ColdFire processor sends a low logical status of a set duration on line BLOCK_PACE Part no 0 48 0029 5 19 May 2003 Technical description of boards Internal device temperature monitoring Temperature probe U36 provides analogue voltage proportional to the internal temperature of the device It is directly applied to the input of the CAD Note The measurement is used
75. ernal Power Detection pe Re ne mare TXD_MC35 D24 D pedege yg e commons men son om e memes on T Ee mem ten em ne i Option or check FENY connection for 73 6V developpement 5V Q22 _ UBAT_FUSED_CPU TL VEE PWR from RTE a Schema No Serial Communication RS232 Bus and 12C Bus WSMO005 SYN2 SCHILLER Project 01 58 E 09 PCB No wsmooo5 pcB2 Date 08 01 03 el eh FA Size A4 Drawn by JME NF Art No WSMO005A Sheet 3 of 9 PNR CEDEX Technical description of boards Starting up of the device when the cell is inserted Inserting the power supply cell starts the device The device runs a self test and switches off after positioning the Status LED indicator and the buzzer alarm depending on the results of the self test Inserting the power supply cell generates a pulse at the gate of Q3 through C69 R102 R103 and R104 The pulse is transmitted to input KS of the clock The clock comes out of the standby mode and sets its PWR output to low That signal makes switching transistor Q22 of the auxiliary power supplies conduct through R121 Q20 R120 Q19 and R123 Notes Do not insist for too long if after the power cell is inserted the device goes off after three seconds and the message FRED IS TESTING has not been displayed on the screen The depletion of the backup cell is accelerated Starting and stopping the device with the On Off key The On Off_Analysis key has a d
76. es the safety discharge relay of the high voltage unit through a transistor The signal is active during the entire defibrillation cycle During battery tests signal WDRA is not active gt input signal WDRA is active when high active at 5 V LHVC Load High Voltage Capacitor Logical signal that directly activates the HV generator in order to charge the HV capacitor The signal is active throughout the HV capacitor charge phase till charging stops gt input signal LHVC is active when high active at 5 V EPDU Enable Patient Discharge Unit Logical signal that powers the shock delivery hardware circuit by means of a transistor The signal is active throughout the hold phase till the shock is administered gt input signal EPDU is active when high active at 5 V UPRA Microcontroller Patient Relay Activation Logical signal from microcontroller U36 that activates a way for triggering the patient relay by means of a transistor The signal is active for 100ms during the defibrillation shock gt input signal UPRA is active when high active at 5 V SHOCK_KEY Shock Key Logical signal coming directly from the Shock key on the CPU PCB gt input signal SHOCK_KEY is active when low when the Shock key is pressed OV if the key is pressed Part no 0 48 0029 5 46 May 2003 Technical description of boards ECGRA ECG Relay Activation Logical signal that controls the ECG relay coil through a transistor function When th
77. ess on the internal wall of the lithium cell slot Access to the connector requires removing the lithium cell When the power supply is derived from an external power source signal INHIBITION U27D 11 switches to low and switches the device to the configuration mode The power supply voltage is brought to the various chopping regulators by means of diode D24 RS232 serial link via the Mini DIN 7 connector The RS232 serial link via the Mini DIN 7 connector P8 is used chiefly for device program updating and configuration It takes care of communication between an external PC and the ColdFire processor It operates at 115 2Kbaud The use of this serial link means that the device is powered through the Mini DIN 7 connector Signal INHIBITION output from U27D switches to low when the device is powered by the Mini DIN 7 connector The Transmit signal generated by the external PC is transmitted to the ColdFire processor through NAND gates U27C and U27A The Receive signal ending at the external PC is a direct connection Signal TXD_GSM is a dual function line First of all it is responsible for communication between the external PC and the ColdFire processor in the configuration mode Secondly it takes charge of communication between ColdFire and the optional GSM when the device is used for an operation All the lines ending in the Mini DIN 7 connector have EMC filters RC network Part no 0 48 0029 5 6 May 2003 Technical description of boar
78. gh the linear regulator built around U15 It is responsible for the operating of the control of the LED STATUS indicator and the buzzer alarm The power to supply 5FL to the control circuitry comes from the pulsed current that passes through status LED D22 which is stored via R154 and D7 in C117 The flashing frequency of indicator LED STATUS is provided by U16 Capacitor C122 fixes the lighting time of indicator LED STATUS and C123 determines its flashing frequency Flashing is started by a pulse 100mS on line CMD_FLASHING_LED_ON Output U14B 9 switches to the low logical status Through Q13 transistor Q23 which shorted status LED D22 switches to the blocked state The flashing cycle is started The flashing is maintained by means of D8 Q14 and Q24 The flashing of indicator LED STATUS is stopped and the buzzer alarm is started through signal SET_ALARM_ON A pulse on line SET_ALARM_ON forces U14B 9 to the high logical status Transistor Q23 is saturated and shorts status LED D22 which ceases to flash At the same time output 6 of U14A switches to the high status Transistors Q15 and Q16 saturate and start the buzzer alarm During the duration of the reset and few dozen milliseconds after that time signal INH2 keeps transistor Q33 blocked During that time the buzzer alarm is blocked The binary counter built around U12A U12B U13A and U13B introduces a delay when the buzzer alarm is started up It is 16 seconds Part no 0 48 0029 5 12 May
79. gh voltage capacitor charge voltage is verified by means of signal CHVM also through multiplexer U31 During the self test the high voltage capacitor charge must be close to OV If any fault is detected during the self test microcontroller U36 sends an error message to the CPU board through the serial link In that case U36 also makes fault latch U18A trip in order to stop the operation of the high voltage part of the defibrillator When the self test of the defibrillator circuit finds no fault the defibrillator enters the standby phase Transfer of information by serial link with the CPU board The exchange of information between the CPU board and the defibrillator part takes place through a serial link At the defibrillator circuit the serial link is directly managed by microcontroller U36 and signals Part no 0 48 0029 5 32 May 2003 Technical description of boards RxD_DEFI and TxD_DEFI Dialogue with the serial link takes place by sending a frame every 100ms The serial link transmits the following information e Information used to test communication between the CPU board and the defibrillator Information corresponding to malfunctioning of the defibrillator part Information corresponding to the standby phase of the defibrillator part Information corresponding to the charging phase of the high voltage capacitor Information corresponding to the status after preliminary charging is completed Information corresponding to the hold phase of
80. gue processing function of the CPU board The signal is filtered from the EMC point of view at the input of the CPU board by a filter made up of C34 and R200 e CHEK BAT VOLTAGE 5 Analogue signal Carries information about the power cell voltage The signal is taken from UBAT_FUSED_CPU through the divider bridge made up of R105 and R127 When the device is switched off transistor Q4 in series with the divider bridge prevents the current from flowing to the ground As a result the gate source voltage of Q31 is zero and the leakage of current to the ADC input is interrupted e DELTA Z analogue signal from the defibrillator Carries information about the impedance variation used for movement detection The signal is filtered from the EMC point of view at the input of the CPU board by aT filter made up of R204 C132 and R197 e TEMPERATURE probe U36 provides analogue voltage proportional to the internal temperature of the device It is directly applied to the input of the CAD e LITH BAT VOLTAGE This signal carries information about the voltage of the backup cell The link between the ADC input and the backup cell is provided through transistor Q34 which is controlled by signal CHEK_CR2032 The control prevents the leakage of current to the ADC input Analogue processing of the ECG signal Analogue processing of the ECG_DEFI signal consists of finally filtering amplifying and offsetting the direct component before it is digitised and special filt
81. he AD converter verification of the operating of the voltage reference of the fault detection circuit and analogue multiplexer U31 verification of the status of the Shock key e verification of the status of the Charge transistor e verification of the charging voltage of the high tension capacitor During the self test all the output ports of the microcontroller are inactive The operating of fault latch U18A is tested by signal SFDU which makes U18A trip In order to check correct latch operation microcontroller U36 reads signal FDUOS through multiplexer U32 During the test signal FDUOS must be high When the test result confirms the operating of the safety latch microcontroller U36 resets U18A by means of signal RFDU The ADC internal to microcontroller U36 is tested is by reading the 5 V and GND voltage via analogue multiplexer U31 Voltage reference U8 2 5 V is also verified by analogue multiplexer U31 That voltage reference is used by the high tension generator and by fault detection comparators The microcontroller also checks the status of the Shock key by means of signal DDIS2 Signal DDIS2 is taken from the Shock key and formed by U35A and the associated components During the test signal DDIS2 must be high The status of charging transistor Q1 is verified through signal CTFC Signal CTFC is that of the voltage present at the drain of Q1 divided by R129 and RR128 During the self test signal CTFC must be close to OV The hi
82. he FRED EASY defibrillator the patient may only be simulated with fixed high voltage and high power resistors that are well insulated from the ground or earth Poorly insulated devices or devices with loose contacts or devices containing components such as spark arresters or electronic flash lamps may never be used as they could irremediably destroy the device Part no 0 48 0029 Page V May 2003 FRED EASY CONTENTS 1 Operation 1 1 Display and controls 1 2 Explanation of symbols used 1 3 Device operation 1 4 Defibrillation procedure 1 5 Recording optional 1 6 Technical specifications 2 1 Functional testing 2 2 Systematic verification before use 2 3 Cleaning and disinfecting 3 Troubleshooting 4 Replacement of parts 4 1 Device disassembly procedure 4 2 Working on the CPU circuit 4 3 Working on the LCD display 4 4 Working on the DEFI circuit 4 5 Replacing the high voltage capacitor 4 6 Reassembling the device 4 7 Replacement of parts 5 Technical description of boards 5 1 FRED easy 5 2 CPU part no WSMO005A 5 3 Defibrillator part no WSM0008A Driving the high voltage capacitor charge 5 3 1 5 3 2 5 3 3 5 3 4 5 3 5 5 3 6 5 3 7 5 3 8 Chronograms Description of signals ECG preamplifier Defibrillator control circuit High voltage circuit IGBT control circuit Fault detection circuit 6 Device modifications 6 1 Definition 6 2 CPU circuit 6 3
83. he HV generator if it is activated inhibits shock validation if has been validated and leads to a safety discharge of the HV capacitor gt input signal DRST is active when low ONOFF_ANALYSE_KEY On Off and Analyse Key Logical signal corresponding to the status of the On Off and Analyse key on the CPU PCB gt input signal ONOFF_ANALYSE KEY is active when low OV when the key is pressed SHOCK_KEY Shock Key Logical signal coming directly from the Shock key on the CPU PCB gt input signal SHOCK_KEY is active when low when the Shock key is pressed OV if the key is pressed RST_DEFI Defibrillator reset Logical signal for resetting the hardware of the defibrillator part Signal controlled by the CPU board gt input signal RST_DEFI is active when high PIOR Patient Impedance Out of Range Part no 0 48 0029 5 44 May 2003 Technical description of boards Logical signal from the patient impedance measurement circuit Signal PIOR is low when the patient impedance is located between approximately 30Q and 200Q The signal is high when the values are not within these limits the value of signal PIOR is located between 0 V and 5 V IPAT Patient Defibrillation Current Analogue signal corresponding to the measurement of the patient current during defibrillation shocks The signal is used to compensate the pulse biphasic wave for the patient impedance With a maximum charge voltage of 2840V the maximum patient current is
84. ified and undergoes low pass filtering thanks to the function built around U6B After that the audio signal is applied via a capacitive link C106 to the input of the power amplifier the output of which attacks the speaker Power amplifier U5 can be put into standby mode with the help of signal POWER_DOWN_AUX ADPCM encoder The ADPCM encoder is responsible for digitally compressing analogue signals taken via an electret microphone The electret microphone is polarised from the 5 V through R92 and R93 The signal delivered by the microphone is transmitted to the encoder through the capacitive link made up of C45 and C46 Resistors R98 R99 R100 and R101 form the gain at the analogue input stage of the encoder The ADPCM encoder is controlled by ColdFire through a serial SPI link with the help of signals SPI_CS1 QSPICLK SPI DATA IN SPI DATA OUT and reset signal POWER_DOWN_AUX The basic frequency of the encoder is 20 48MHz The data transmission baud rate is supplied by signal BCLKT The frame synchronisation frequency is given by signal SYNC _FST It is 8KHz All these frequencies are provided by the intermediate clock generation function that is built around U2 The encoded data are transmitted to the ColdFire processor through signal ADPCM_ENCODE Signals DATA_CODEC_RX and BF_PCM_MOTOROLA are part of the decoder function of MC145540 which is not currently used Intermediate clock generation Intermediate clocks CLK_20M48HZ and CLK4M
85. ignal generated by the ColdFire processor to show that writing is under way on the data bus 10 Hz Signal generated by the ColdFire processor for the amplification circuit test 10 Hz_4066 10 Hz signal with dynamics extended to 5 V and 5 V 3 3 V 3 3V auxiliary power supply voltage Mainly used by the digital part of the CPU board 3 6 V 3 6V auxiliary power supply voltage GSM telephone power supply 5 V 5V auxiliary power supply voltage Power supply of the analogue part of the CPU and the defibrillator and the digital part of the LCD 5 V 5 V auxiliary power supply voltage Power supply of the analogue part of the CPU and the defibrillator Part no 0 48 0029 5 27 May 2003 Technical description of boards 5 3 Defibrillator part no WSM0008A Defibrillator printed circuit The lower part of FRED Easy includes the housing for the MnO lithium cell and the defibrillator printed circuit The defibrillator printed circuit WSM 0008_PCB includes the following different parts e ECG preamplifier The ECG preamplifier is responsible for acquiring the ECG signal taken by means of adhesive defibrillation electrodes e Defibrillator control circuit The control circuit part of the defibrillator is responsible for controlling the charging and discharging of the high voltage capacitor e High voltage circuit and capacitor The high voltage circuit part is responsible for charging and discharging the high voltage condenser
86. ing Part no 0 48 0029 Page 4 4 May 2003 Replacement of parts 4 6 Reassembling the device To put back the device reverse the procedures Instructions for assembling the connector between boards AVR ON Short connections on the DEFI circuit 4 7 Replacement of parts o Parts may only be replaced by personnel who have been specially trained and authorised by Schiller Medical Besides the replacement parts shall be original Schiller Medical parts S To order a new part from Schiller Medical provide the part number and the serial number of the device located under the device After that specify the item code of the part the part number the description provided in the list of parts and the ECL of the replaced part Part no 0 48 0029 Page 4 5 May 2003 17 55 59 50 45 47 37 59 CPU BOARD LCD WSMOO005A 58 LCD FLAT CABLE 4 15 0000 57 LED GREEN 4mm 4 58 0000 56 DISK 7mm 6 87 0002 55 2 LED GREEN SQUARE FORM 4 58 0001 54 BATTERY EJECT BENDER 6 60 0001 51 HIGHT VOLTAGE CONTACT GUIDE 6 66 0000 50 5 DISK 4 5mm 6 87 0000 48 DUST PROTECTION 6 64 0001 47 BUZZER PROTECTION 37 1 58 0402 45 CPU SHIELD 1 58 0400 43 6 BATTERUY CONTACT 6 60 0000 42 41 EMORY CARD COVER 6 64 0000 40 HV CAPACITOR 4 19 0021 37 BUZZER PROTECTIO
87. interface is controlled by the ColdFire processor through the serial link RXD_GSM TXD_MC35 and signal GSM_IGNITION It is powered with 3 6 V via L9 Signal SYNC_POWER_BURST acts on voltage 3 6 V which is slightly raised during the GSM emission phase Audio signals SPEECH_GSM_PLUS and SPEECH_GSM_MINUS are amplified by the audio amplifier and rendered by the device speaker Lines MIKE_GSM_PLUS and MIKE_GSM_MINUS are those of the audio signal recorded by electret microphone MK1 Connector P2 is used for the GSM SIMM card Part no 0 48 0029 5 24 May 2003 Technical description of boards Description of labels and port modules Label and port module A O 22 ADPCM_ENCODE A10_PRECHG BA O 7 BACK_005HZ BATT_NC BCLKT BD_CS B_D 16 31 BDM_CPU_CLK BF_PCM_ MOTOROLA BKPT BLOCK_PACE CHEK_BAT_VOLTAGE 5 CHEK_CR2032 CHOC_KEY CLK4M096 CLK20M48HZ CMD_FLASHING_LED_ON CMD_LED_ANALYSE CMD_LED_CHOC CMD LED ELECTRODE CS 0 7 CS7 D 0 31 DATA CODEC_RX DDATA O 3 DELTA Z DETECT_PACE DET_PRESENT_SDCARD DISPO_DEFI_3 DSCLK DSI DSO DTEA ECG_ADC ECG_DEFI ECG LB ECG _PACE_TEST ECG_ADC FLASH_BUSY FST_INHIB Description ColdFire address bus Encoded ADPCM data transmitted to ColdFire SDRAM control signal Amplified address bus ECG _LB signal trace retrieval command after a defibrillation shock Active when high Not used Synchronisation signal of the serial transmission of ADPCM e
88. ion Signal of port BDM and JTAG Not involved in device operation Signal of port BDM and JTAG Not involved in device operation Analogue ECG signal applied to the ADC input Analogue ECG signal delivered by the defibrillator preamplifier Analogue ECG signal with a narrow bandwidth given by the defibrillator preamplifier Pacing pulse detection disabling signal Active when low End of conversion signal indicating the availability of converted data Status signal of the flash memory Active when low Disabling of signal SYNC FST during the ADPCM encoder initialisation phase GSM_IGNITION GSM telephone starting signal Active when high INH1 INH2 Part no 0 48 0029 Signal introducing a disabling time for the On Off key saving latch Signal introducing a disabling time for the Buzzer alarm start saving latch 5 25 May 2003 INHIBITION INH_PACE INH_PACE_4066 Technical description of boards Signal that switches the device to the configuration mode Active when low Signal for opening the amplification circuit analogue switch when a pacing pulse is detected Signal INH_PACE with dynamics extended to 5 V and 5 V MIKE_GSM_MINUS MIKE_GSM_PLUS MTMOD OE OKI_FIFO_MID ONOFF_ANALYSE_KEY POWER_DOWN_AUX PST O 3 PUSH_BUTTON_CHOC PUSH BUTTON POWER ON QSPICLK RASO RST_DEFI RSTO RTC_PF_RESET RTC_WATCH_DOG RXD_DEFI SDCLKE SDC_WRITE_PROTECTED SDWE SET_ALARM_ON SPI_CSO SPI_CS1
89. l when signal CTFC is greater than 1 0V before the HV capacitor charge starts gt signal CTFC must be located between 0 and 5 V at the most Part no 0 48 0029 5 45 May 2003 Technical description of boards RIPAT Read Defibrillation Patient Current Logical signal that corresponds to datum DO of the IGBT control circuit EPROM The signal is identical to signal FPIC The first pulse of signal RIPAT is used to synchronise microcontroller U36 for calculating the patient resistance at the first current pulse gt signal RIPAT is active when high active at 5 V FDUO Failure Discharge Unit Output Logical signal corresponding to the triggering of the safety latch The safety latch must be triggered voluntarily when the device is started up In order to check operation triggering takes place through signal SFDU If any hardware faults are found the fault latch is triggered by one of the input signals CHVM DUFD IGFD or SFDU When the latch is triggered signal FDUO is high gt output signal FDUO is active when high active at 5 V Output signals of the defibrillator control circuit EHVG Enable High Voltage Generator Logical signal that powers the high voltage unit When the signal is active it activates the charge transistor in order to enable an HV capacitor charge request or a battery test gt input signal EHVG is active when high active at 5 V WDRA Energy Dump Relay Activation Logical signal that activat
90. lation electrodes The signal is used to determine the patient impedance in order to check if the defibrillation electrodes are glued correctly gt signal Z_ELEC_DEFI is located between OV and 5 V at the most PIOR Patient Impedance Out of Range Logical signal from the patient impedance measurement circuit Signal PIOR is low when the patient impedance is located between approximately 30 Q and 200 Q Outside these limits the signal is high the value of signal PIOR is located between 0 V and 5 V ECG LB Large Band Defibrillator ECG Analogue signal corresponding to the lower frequency range of the patient ECG signal Signal ECG_LB has a gain of about 250 as compared to the input signal signal ECG_LB is located between 5 V and 5 V at the most DELTA Z Patient Impedance Variation Analogue signal that is used to recognise major variations in the patient impedance by the CPU board Signal DELTA _Zis derived from the main patient impedance measuring circuit gt signal DELTA _Z is located between 5 V and 5 V at the most 5 3 5 Defibrillator control circuit Input signals of the defibrillator control circuit TYPE_ELECTR Defibrillator Electrode Type Analogue signal that is used to identify the type of defibrillation electrodes gt input signal TYPE_ELECTR is located between 0 and 5 V INHIBITION Defibrillator Disable Logical signal that triggers the resetting of the defibrillator function The signal stops t
91. lation hardware module has not found any error e EEPROM configuration test it is used to make sure that access to the EEPROM containing device configuration information is valid and that the information is consistent e RTC test used to validate the operating of the real time clock of the device e Battery test used to validate the battery level the test shows an error if the remaining battery charge is 0 e LCD test used to validate the display e OKI test used to validate the speech prompt system e Encoder test used to validate the operating of the sound environment acquisition system If any of the tested peripherals shows an error the device cannot be used In that case the device status display flashing LED is changed to indicate that the device may not be used the LED goes off and a message indicates the test that has failed When the LED goes off a buzzer is triggered to indicate a device fault If the tests succeed the device executes the SAD operating mode Part no 0 48 0029 Page 2 1 May 2003 Testing and maintenance Specific case of periodic tests Because the device is used in emergency situations it must be ready to operate when it is needed As a result self tests are insufficient That is why periodic testing is performed to maximise the chances of detecting any error in the device including when it is not used Periodic testing includes the following operations e Selftests
92. ler U36 does not authorise the defibrillation shock and directly triggers Part no 0 48 0029 5 34 May 2003 Technical description of boards the safety discharge of the HV capacitor Signal PIOR from the ECG preamplifier part is reversed by transistor Q20 and its associated components to generate signal PIMP Determination of patient impedance during the shock The first IGBT control pulse generated by U16 lasts 50us and makes IGBTs Q7 and Q12 of phase1 conduct Signal RIPAT which corresponds to the first control pulse is also read by microcontroller U36 Microcontroller U36 uses the signal as a synchronisation signal to measure the patient peak current The patient peak current is measured by signal IPAT taken from the patient discharge circuit through R203 From the HV capacitor charge voltage read through signal CHVM and the value of the patient current microcontroller U36 determines the patient resistance value Control of the patient impedance compensated biphasic waveform After calculating the patient resistance value microcontroller U36 sends a databank from memory U16 through signals PBSBO PBSB1 and PBSB2 The different memory banks U16 contain information for IGBT control depending on the patient resistance Signals FPIC and SPIC control the conduction of the HV switching circuit IGBTs in order to generate a patient impedance compensated pulse biphasic waveform During the defibrillation shock signals FPIB and SPIB trigger the ac
93. llation pulse Modulated defibrillation pulse with two pulse phases and physiologically optimised phase duration of 4 ms Constant value of the average current delivered and the energy discharged depending on patient impedance using pulse modulations in the pause position in the two phases Modulation of the second phase negative phase so that the residual charges of the first phases are degraded in the heart e Standard energy settings Adult discharge in 50 90 130 150 J Child automatic switch when child electrodes are connected 15 30 50 J The energy levels can be configured by the technical assistance department of Schiller if the standard values need to be changed 1 2 4 6 8 15 30 50 70 90 110 130 150 J Adult 1 2 4 6 8 15 30 50 70 Child Tolerance at 50 Q 3 J or 15 whichever is greater 100 0 80 0 60 0 Ohms 40 0 50 Ohms 75 Ohms 100 Ohms 20 0 125 Ohms he 150 Ohms re UU il 175 Ohms l gt Te SEE Aa Chie a i JU EAU RAI 20 0 Pt D 40 0 time ms e Automatic charge control after a shock is recommended following an analysis e Patient resistance 30 175 e Charge duration from the time a shock is recommended up to the time when the device is ready lt 10s e Cycle time between two shocks lt 20s e Indication that the devices is ready to deliver a shock key Y goes on e The shock is delivered with key W e Internal safety di
94. m X 186 5mm z N 2 o R22 o Rza R254 C54 R231 R230 FRED EASY Circuit D fibrillateur Defibrillator PCB APPROV MODIFICATION R235 ART WSM0008A CK PRT WSM0008 PCB2 ECL200 DGW WSMO008AREF200 SC H L L E 11 02 SHT 1 1 SIO O omza 2 i MEDICAL S A Sch mas et plans d implantation WSM0008_PCB3 Art N 0 48 0015 7 6 Mai 2003
95. mplifier ECG preamplifier input signals 5 VA Filtered positive power supply voltage Filtered 5 V power supply voltage specific to the ECG preamplifier part gt the voltage value is located between 4 6 V and 5 2 V 5 VA Filtered negative power voltage Filtered 5 V power supply voltage specific to the ECG preamplifier part gt this voltage value is located between 4 6V and 5 2V ECG1 ECG signal from the Defi connector ECG signal from the Defi connector transmitted by a make contact of the ECG relay During defibrillation shocks signal ECG1 is insulated from the Defi connector for 100ms gt signal ECG insulated from the Defi connector during the defibrillation shock ECG2 ECG signal from the Defi connector ECG signal from the Defi connector transmitted by a make contact of the ECG relay During defibrillation shocks signal ECG2 is insulated from the Defi connector for 100ms gt signal ECG insulated from the Defi connector during the defibrillation shock INH_PACE Pacemaker Inhibition Logical signal generated by the CPU board to activate the analogue switches in the ECG signal amplification circuit if pacemaker pulses are detected If pacing pulses are detected signal INH_PACE becomes active for the duration of the pacing pulse the value of input signal INH_PACE is located between 5 V and 5 V The signal is active when low active at 5 V BACK_005HZ Back 0 005Hz Filter Logical signal genera
96. ncoded data bits Data bus buffer control signal Amplified data bus Signal of port BDM and JTAG Not involved in device operation Audio output of ADPCM encoder Not used Signal of port BDM and JTAG Not involved in device operation Controls the opening of the analogue switch of the amplification chain to suppress the pacing pulse Active when low Control signal of data transfer between the SDRAM and ColdFire SDRAM control signal Analogue signal of the battery voltage measurement Control signal of backup cell voltage monitoring Active when high Signal resulting from Shock key activation Active when low 4 096MHz clock 20 48MHz clock Control signal of the starting of the STATUS LED and resetting of the saving latches of keys ONOFF_ANALYSE and SHOCK Control signal of the LEDs of key ONOFF_ANALYSE Control signal of the LEDs of the Shock key Control signal of the adhesive electrode input LED Bus made up of different CSs SDRAM activation signal ColdFire data bus Reception of encoded ADPCM data Not involved in device operation Signals of port BDM and JTAG Not involved in device operation Analogue signal of the patient impedance measurement used to detect movements Pacing pulse detection signal Active when low SDCard present detection signal Active when low Not used Not used Not used Signal of port BDM and JTAG Not involved in device operation Signal of port BDM and JTAG Not involved in device operat
97. nction key On Off and Analysis for controlling device switching on and off Its other function consists in enabling the starting of a patient signal analysis Two green LEDs indicative of the On Off Analysis keys offer an additional visual interface for the user The SHOCK key controls the delivering of a defibrillation shock The orange LEDs indicative of the Shock key offer an additional visual interface for the user Status LED that continuously indicates the success of the last device self test A buzzer to indicate any anomaly found at the last self test An Electrode Fault LED to indicate where the defibrillation electrodes are to be connected Also provides information about the continuity of the electrical circuit A speaker for the messages intended for the user A microphone for recording the sound in the environment An MMCard for recording the ECG signal the events of the operation and the environment sounds A Mini DIN 7 connector for the serial link with a PC in order to download programs and configure FRED easy During these operations the board is powered by an external power source through the same connector Part no 0 48 0029 Page 5 1 May 2003 its Soldered DEFIBRILLATOR BOARD WSM0008 12V 2 8Ah Central Process Unit CPU BOARD WSM0005 Analog Process 5 ADPCM DISPO DEFLS of Serial Encode Decode JPI CPU MMC ECG ADC Amplificati
98. nd names appearing in this manual The FRED EASY device shall be used as described in the User s Manual The device may not be used for any purpose that has not been specifically described in the manual as such use could be hazardous Part no 0 48 0029 Page May 2003 FRED EASY SAFETY INFORMATION e The product is marked as follows CE 0459 in accordance with the requirements of Council Directive 93 42 EEC relating to medical equipment based on the essential requirements of annex of the directive e It fully meets the electromagnetic compatibility requirements of standard IEC 60601 1 2 EN 60601 2 Electromagnetic compatibility of medical electrical devices e The device has undergone interference suppression in accordance with the requirements of standard EN 50011 class B e In order to optimise patient safety electromagnetic compatibility accurate measurement indication and proper device performance users are advised to use only original spare parts supplied by SCHILLER Any use of accessories other than original accessories shall be at the exclusive risk of the user The manufacturer shall not be liable for any damage due to the use of incompatible accessories or consumable supplies e The manufacturer shall only be liable for the safety reliability and performance of the device if assembly configuration modifications extensions or repairs are made by personnel from SCHILLER MEDICAL or personnel duly autho
99. nduction by Q19 through signal FDUO and consequently the safety discharge of the HV capacitor see previous paragraph HV switching circuit monitoring Monitoring of the charge voltage of the HV capacitor Surge voltage in the event of a charge stopping circuit fault is detected by comparator U20B which monitors the amplitude of signal CHVM When the HV capacitor charge voltage reaches approximately 3 3KV signal CHVM divided by R208 and R209 triggers comparator U20B which activates fault latch U18A through U20A The safety discharge of the HV capacitor and the stopping of the HV generator is achieved as described previously see previous paragraph monitoring the HV switching circuit Part no 0 48 0029 5 39 May 2003 5 3 2 Chronograms signal PPG1 signal PPG2 signal EHVG UCHARGE Drain Q1 signal WDRA LHVC VDS Q4 UBATT 0 signal nan 0 signal CHVM Part no 0 48 0029 Technical description of boards Preliminary charging of the HV capacitor Charge triggering by information PRE CHARGE REQUEST 7 HTML I I I i I I t I Safety discharge relay activation 50 ms a 65 V nn UBATT t I Selected energy reference 150 J VREF 3 33 V End of charge for U HT 2831 V 150J CHVM 2831 850 3 33 V 3 33 V May 2003 Technical description of boards Preliminary charging and charging of the HV capacitor HV capacito
100. nsertion test is logged The logged data include test date e testtime e test result OK e reset information to indicate that a problem had been found during periodic tests and has been corrected If the tests are completed successfully the device goes off automatically at the end of the operation Otherwise the device stays on to indicate the failed test 2 2 Systematic verification before use Before each use of the device the device cables connectors and electrodes must undergo a visual inspection If you find any faults or malfunctioning that could impact the safety of the patient or the user do not use the device before it is repaired Systematic verification before each use e Verification of the device housing e No mechanical damage e No penetration of liquid in the device e Check the condition of the control buttons and the connectors 2 3 Cleaning and disinfecting Caution Switch the device off before cleaning it Remove the cell before you start cleaning the device in order to eliminate the risk of the device starting up accidentally Also disconnect the defibrillation electrodes of the device before cleaning No liquid shall be allowed to enter into the device However if that does happen the device may not be used before it is verified by the after sales service department The device or electrodes may never be cleaned with substances such as ether acetone esters aromatic chemicals etc Nev
101. ntrol circuit activates the high voltage generator signal LHVC till the new selected energy is reached When the energy stored in the high voltage capacitor is equal to the selected energy the microcontroller stops the high tension generator and authorises defibrillation shocks signal EPDU The defibrillator is now in the hold phase during which the energy stored is measured by signal CHVM During the hold phase when the Shock key directly interconnected with the defibrillator circuit is pressed the defibrillator control circuit sets off the defibrillation shock through two independent channels The first shock triggering Part no 0 48 0029 5 31 May 2003 Technical description of boards channel is made up of the signal taken directly from the Shock key signal SHOCK KEY The second defibrillation shock triggering channel is provided by the microcontroller of the defibrillator control circuit signal UPRA of a duration of 100ms The two signals above activate the patient relay of the high voltage unit Signal UPRA also validates the counter of the IGBT control circuit After 25ms the first defibrillation pulse is generated by the IGBT control circuit During that first pulse the microcontroller measures the defibrillation current through signal IPAT in order to determine patient resistance When the patient resistance has been determined the microcontroller sends a databank corresponding to the patient resistance by means of signals PBSBO PBSB
102. ock SDRAM bus clock control signal Signal indicating that the SDC is write protected Active when low SDRAM control signal Buzzer alarm start pulse CS0 address selection signal of the SPI serial link CS1 address selection signal of the SPI serial link CS3 address selection signal of the SPI serial link Serial data of the SPI link read by the ColdFire processor Serial data of the SPI link generated by the ColdFire processor Synchronisation signal of the serial transmission of ADPCM encoded data frames Signal generated by the mobile phone that controls the 3 6 V power supply during the emission phase Configuration signal of port BDM and JTAG Not involved in device operation Child Adult electrode recognition RS232 serial communication link between the ColdFire processor and the defibrillator Signal generated by the defibrillator microcontroller The signal also ends on the Mini DIN 7 connector RS232 serial communication between the ColdFire processor and an external PC Signal generated by the PC The signal also ends on the Mini DIN 7 connector RS232 serial communication link between the ColdFire processor and the GSM telephone Signal generated by the GSM telephone Device power voltage Power voltage after the protection fuse 5 26 May 2003 Technical description of boards UBAT_SWITCHED Switched power supply voltage Backup cell voltage 2 5 V reference voltage LCD negative power voltage WE S
103. of the two mid points of the H bridge If the leakage current is too great the potential is not balanced The two signals IGBT_FD1 and IGBT_FD2 at the output of the balancing network attack differential amplifier U13A When the output amplitude of U13A is greater than the limits set by window comparator U13B and 13C signal IGFD switches to low Signal IGFD triggers fault latch U18A through comparators U20C U20D and U20A The triggering of the fault latch makes transistor Q19 conduct through signal FDUO which deactivates signal EHVG In those conditions the power supply voltage UCHARGE disappears making the HV generator stop if it is charging and the HV capacitor undergoes a safety discharge The triggering of fault latch U18A also generates a fault signal recognised by microcontroller U36 through signal FDUOS Microcontroller U36 deactivates all its active outputs and supplies an error message transmitted to the CPU board through the serial link Monitoring of patient relay activation transistors Faults in patient relay activation transistors Q6A and Q6B are detected through signal DUFD If one of the two transistors is shorted the idle potential of signal DUFD polarised by R69 and R70 is modified That variation is detected by means of a window comparator made up of U19B and U19C After a duration of approximately 2 5s fault latch U18A is triggered through U19A U19D and U20A As described above the triggering of the fault latch leads to co
104. on SCL CHOC_KEY ONOFF_ANALYSE KEY RST_DEFI TXD_DEFI Microcontrolle Ted Katus gt rot ECG DEFI gt Alarm Buzzer JP2 INF PACE JP4 Process 43 Unit TYPE ELECTR BACK O05HZ LCD Interface JP3 DISPO DEFI 1 Serial Com naa DEL Start Stop INHIBITION RS232 LC Power JP6 SOLDERED ON PCB BOARD 77 dm o 5 o CHOC KEY ONOFF ANALYSE KEY LED ELECTRODES QO 77 Z7 77 ELECTRET MICROPHONE LED STATUS Connector LED CHOC LED ANALYSE SPEAKER BUZZER 6 Scherra No Central Process Unit WSM0005_SYN2 l Project 01 58 E09 PCB No WSV0005 POB2 Date 08 01 03 OT LR S A3 Dramby JME NF lart No wavaa Sheet t 9 Peur Technical description of boards 5 2 CPU part no WSM0005A The paragraphs below outline the various functions of the CPU board General description The CPU board includes a ColdFire host microcontroller U23 the working RAM U7 and U39 and the flash memory U37 The ColdFire processor is driven by a 40 96MHZ quartz The CPU controls the following basic functions Data bus amplification Address bus amplification Auxiliary power supplies Power supply by the Mini DIN 7 connector RS232 serial link via the Mini DIN 7 connector Configuration EEPROM Communication between the ColdFire microprocessor and the defibrillator Starting up of the device when the cell is inserted Starting up of the device by th
105. on the calculated patient impedance gt signal PBSB1 is active when high active at 5 V Part no 0 48 0029 5 50 May 2003 Technical description of boards PBSB2 Patient Bank Selection Bit 2 Third of the three encoded bits used to select the different EPROM banks depending on the calculated patient impedance gt signal PBSB2 is active when high active at 5 V PPG1 Prepulse Generator Logical signal that blocks the IGBTs through cores during the charging preliminary charge completed and hold phases Signal PPG1 has a period of 16ms The current pulses in the cores have a duration of 100us gt signal PPG1 is active when low active at OV PPG2 Prepulse Generator Logical signal that blocks the IGBTs through cores during the charging preliminary charge completed and hold phases Signal PPG2 has a period of 16ms The current pulses in the cores have a duration of 100us Signal PPG2 is offset by 8ms in relation to PPG1 gt signal PPG2 is active when low active at OV UPRA Microcontroller Patient Relay Activation Logical signal from microcontroller U36 that activates a way for triggering the patient relay by means of a transistor The signal is active for 100ms during the defibrillation shock gt input signal UPRA is active when high active at 5 V Output signals of the IGBT control circuit RIPAT Read Defibrillation Patient Current Logical signal that corresponds to datum DO of the IGBT con
106. or control circuit tests the fault detection circuit in order to check operation signals SFDU and RFDU The fault detection circuit monitors the following e no abnormal leakage current from the IGBT switching circuits signal IGFD e no short circuit of the patient relay activation transistors signal DUFD e no out of range HV capacitor charge voltage signal CHVM The various fault conditions above trigger a latch that directly deactivates the high voltage unit leading to the safety discharge of the HV capacitor The safety latch also supplies a fault signal to the microcontroller of the defibrillator control circuit signal FDUO which then deactivates all its outputs and sends an error message to the CPU board Fault detection circuit test When the FRED easy device is switched on microcontroller U36 tests the operating of fault latch U18A When the 5 V power supply voltage appears the circuit made up of R167 and C49 resets latch U18A through gate U17C During the self test microcontroller U36 triggers fault latch U18A through signal SFDU and gate U17B After checking the operating of the latch by reading signal FDUOS microcontroller U36 resets the fault latch to zero through signal RFDU HV switching circuit monitoring The detection of abnormal leakage currents from the IGBT switching circuit is achieved by means of two resistor chains R188 R189 R115 and R191 R190 RR116 which form a network that balances the potential
107. put on signal DDIS2 Signal DDIS2 is applied by microcontroller U36 When signal DDIS2 is active for more than 150 ms U36 generates a high level on signal UPRA for 100ms The second way for activating the patient relay is made up of transistor Q6A which is activated by signal SHOCK_KEY and transistor Q3 In order to excite the patient relay the two triggering ways must be active During the 100ms of activation of the patient relay the ECG relay is de excited disconnecting the ECG preamplifier from the high voltage circuit The ECG relay is controlled by signal ECGRA taken directly from the coils of RI5 and RL6 When patient relay RL5 and RL6 is excited the patient is connected to the high voltage circuit of the defibrillator For the 100ms during which signal UPRA is high the control circuit of the pulse biphasic wave is activated by signal UPRA reversed by open collector driver U33C The pulse biphasic wave control circuit is made up of oscillator U14 which generates a 50us clock counter U15 and memory U16 The first control pulse of the IGBTs is generated 25ms after the activation of U15 and UU16 by signal UPRA When the Shock key is pressed the microcontroller checks the status of the PIOR signal corresponding to the patient impedance range in which the defibrillation shock is authorised When signal PIOR is low the patient impedance is located from 30Q to 200Q and the defibrillation shock is authorised When signal PIOR is high microcontrol
108. r s manual contains a troubleshooting table intended for the user The device is not switched on when the battery is inserted When the cell is inserted the self test succeeds but the OK indicator does not flash No display of message FRED IS TESTING When the cell is inserted no self test but the OK indicator flashes The self test succeeds but the OK indicator does not flash The screen stays on for 5 s The On Off key does not respond No display and or no voice messages Message DEFIBRILLATOR CPU ERROR Part no 0 48 0029 POSSIBLE CAUSES 1 Cell fault 2 Incorrect insertion 3 Problem with contacts 4 Problem with fuses 1 Fuse F1 on CPU board faulty 1 Check the button cell on the CPU out of order or down 2 Check if F1 is faulty on DEFI board 3 CPU board faulty 4 DEFI board faulty 1 CPU board faulty 1 CPU board faulty 1 CPU board faulty 1 DEFI board Page 3 1 CORRECTIVE ACTION Replace the cell Repeat the insertion Check contacts Check fuses Replace fuse Replace the button cell Replace fuse Replace CPU Replace DEFI board Replace CPU Replace CPU Replace CPU Replace DEFI board May 2003 Message DEFIBRILLATOR INTEGRITY ERROR PROGRAM Message DEFIBRILLATOR DETECTOR ERROR Message DEFIBRILLATOR ERROR VOLTAGE REFERENCE Message DEFIBRILLATOR CONVERTER ERROR ADC Message DEFIBRILLATOR CHARGE TRANSI
109. r charging initiated by information PRE CHARGE REQUEST signal EHVG 0 I signal l i WDRA 0 T I a HV capacitor charge initiated bas 208 by information signal l CHARGE REQUEST LHVC i I l 0 50 ms Tmax 30s I signal Thax 155 i l l I l 1 l 0 i l i 50 ms Tmax 20 s l soms masas J UDISCHEN pon l Drain Q5B l l l l l l I l l I l l MR E signal i i l UBATT I I l he a t signal PPG2 l l I l 0 i T i l f Current l l phase i l l 1 STANDBY CHARGE CHARGE HOLD SAFETY PHASE PHASE PHASE PHASE DISCHARGE PHASE PRE CHARGE COMPLETE PHASE Part no 0 48 0029 5 41 May 2003 Technical description of boards Hold phase and defibrillation shock signal EHVG signal WDRA signal LHVC i I j signal i EPDU l 1 j i _50 ms rat UDISCHEN i l Drain Q5B UBATT D fe 1 CHARGE l l SHOCK key pressed i SHOCK key l l pressed l i i 0 Tmin 150ms 16sec 7 ignal i TER 1 Activation du i i relais patient l S l l E T 100 ms L t Defibrillation i current l i i I I I Io J i i l t I I I Current l phase IE mr STANDBY 1 CHARGE HOLD I sHocK _ SAFETY PHASE PHASE Part no 0 48 0029 5 42 May 2003 5 3 3 Technical description of boards Description of signals The names of signals refer to the chart of the FRED Easy Defibrillator 5 3 4 ECG prea
110. rd fault CPU board fault DEFI board faulty DEFI board faulty CPU board fault Memory card CPU board fault Button cell CPU board fault Page 3 3 1 1 Check cell contact 1 2 Replace cell Replace DEFI board Replace CPU board Replace DEFI board Replace CPU board Replace speaker Replace CPU board Replace buzzer Replace CPU board Replace CPU board Replace DEFI board Replace DEFI board Replace CPU board Replace memory board Replace CPU board Replace button cell Replace CPU board May 2003 Replacement of parts 4 Replacement of parts This section addresses the issue of how to dismantle FRED easy in order to replace faulty parts The warnings below apply to all work inside the device FRED easy is a defibrillator with a high voltage capacitor that can be charged to a fatal voltage The device may only be dismantled by specially authorised and trained personnel Caution Before dismantling the device remove the battery or the cell from its slot Caution The device contains circuits sensitive to electrostatic discharge All work on the FRED easy device shall be performed in accordance with ESD rules The repairs shall be performed on an antistatic mat connected to the earth and the operator shall wear an antistatic strap also connected to the mat In the event of any work on the high voltage part of the defibrillator remove the antistatic strap
111. rised by SCHILLER MEDICAL the device is used in accordance with its instructions for use e Any use of the device other than as described in the instructions for use shall be made at the exclusive risk of the user e This manual covers the device version and the safety standards applicable at the time of printing All rights reserved for the circuits processes names software and devices appearing in this manual e The quality assurance system in use in the facilities of SCHILLER meets international standards EN ISO 9001 and EN 46001 e Unless otherwise agreed in writing by SCHILLER no part of the manufacturer s literature may be duplicated or reproduced Part no 0 48 0029 Page III May 2003 FRED EASY Safety symbols used on the device Danger High voltage Conventions used in the manual indicates an imminent hazard which if not avoided will result in death or serious injury to the user and or others Warning indicating conditions or actions that could lead to device or software malfunctioning Useful information for more effective and practical device operation Additional information or explanation relating to the paragraphs preceding the note Manufacturer SCHILLER MEDICAL SA 4 rue Louis Pasteur ZAE sud F 67 162 Wissembourg Tel 33 0 3 88 63 36 00 Fax 33 0 3 88 94 12 82 Part no 0 48 0029 Page V May 2003 FRED EASY PRECAUTIONS WHILE TESTING THE DEVICE While testing t
112. rised during the hold phase through transistor Q5B and signal EPDU generated by open collector driver U33B Part no 0 48 0029 5 37 May 2003 Technical description of boards Defibrillation peak current measurement At the first IGBT control pulse generated by memory U16 IGBTs Q7 and Q12 are made to conduct for 100us During that time microcontroller U36 acquires the peak current value in order to determine the patient resistance value The defibrillation peak current is measured through shunt resistor R203 which is located in the patient discharge circuit Signal IPAT_M collected at the terminals of R203 attack follower U2B by means of a protection and clipping network to generate signal IPAT Signal IPAT corresponds to the value of the peak defibrillation current divided by 35 HV capacitor safety discharge The safety discharge of the HV capacitor is achieved by means of safety discharge relay RL4 and power resistor R192 When signal WDRA generated by microcontroller U36 switches to low transistor Q5A stops conducting In those conditions the coil of safety discharge relay RL4 is de excited which leads to the closing of the contacts and a safety discharge of the HV capacitor into resistor R192 IGBT control circuit The IGBT control circuit part performs the following functions e Blocking of IGBTs during the charging and hold phases e IGBT control in order to generate the patient impedance compensated pulse biphasic waveform during
113. rted up by switching signal SWITCHED_GND to the ground That is achieved by transistor Q16 of indicator LED STATUS The oscillator built around U17C and U17D generates the attack frequency KHz of the buzzer The current is amplified by followers U19A to U19F The buzzer attack signal is modulated by a signal generated by oscillator U17A U17B and divider U The modulation is applied to the oscillator of the buzzer attack frequency through an OR logical gate built around D10 D11 and R137 Note Regardless of the starting mode weekly self test starting with On Off key or due to battery insertion the buzzer alarm starts up as soon as the device is started It stops after a few seconds if no fault is found during the self test Otherwise the buzzer alarm persists till the power cell capacity is depleted LED STATUS indicator The LED STATUS indicator is a visual indicator that flashes at 0 5Hz If no error is found the LED STATUS indicator flashes regardless of the device status off or on providing the power cell is in place Note The operating of the LED STATUS indicator is closely linked to that of the buzzer alarm If the indicator does not flash the buzzer alarm must start But the very fact that the LED STATUS indicator does not flash shows a technical fault The LED STATUS indicator is powered by UBAT FUSED CPU The 5FL auxiliary power supply voltage is provided from the voltage taken from the terminals of C117 throu
114. scharge if the heart rate does not call for defibrillation after 20 seconds of the device indicating its readiness for a shock no shock is delivered there is an electrode fault the battery voltage is insufficient the device is faulty the device is switched off e The shock is delivered with single use adhesive electrodes applied in the anterior anterior lateral positions e BF type defibrillation electrode connector Part no 0 48 0029 Page 1 7 May 2003 Operation Defibrillation electrodes Adult electrodes Active area 78 cm Child electrodes Active area 28 cm Electrode cable length 2 m VT VF recognition Shock recommendation for VF and VT VT gt 180 bpm Sensitivity 98 43 Specificity 99 8 These values have been found with the AHA database which contains cases of VF and VT with and without artefacts Conditions required for ECG analysis Minimum amplitude for the signals used gt 0 15 mV signals of lt 0 15 mV are considered to show asystole Definition Sensitivity Correct detection of heart rates for which defibrillation shocks are recommended Specificity Correct detection of heart rates for which defibrillation shocks are not recommended Display LCD 100 x 37 mm high definition with EL backlighting display of text and icons Recording of the use of the device optional ECG recording half an hour Voice recording half an hour Event recording 500 events
115. t occupy the space under the high voltage capacitor The ECG preamplifier part amplifies the ECG signal and measures the patient impedance The ECG signal from the patient is collected through adhesive defibrillation electrodes The amplified ECG signal is transmitted in the analogue form to the CPU board signal ECG DEF The CPU board directly controls the ECG preamplifier if pacemaker pulses are detected signal INH_PACE The ECG signal acquisition circuit test is also controlled by the CPU board when the FRED easy device is started up 10 Hz signal The ECG preamplifier also contains an extended lower bandwidth stage signal ECG_LB In the event of an overrun the CPU controls this stage through signal BACK_OO5HZ The ECG preamplifier part is also responsible for measuring the patient impedance through a 22KHz sinus signal After processing a signal corresponding to the value of the patient impedance is transmitted to the CPU board in analogue form signal Z_ELEC_DEFI The signal is also used by the defibrillator control circuit in order to enable defibrillation shocks only if the defibrillation electrodes are glued correctly signal PIOR Part no 0 48 0029 5 29 May 2003 Technical description of boards ECG preamplifier power supply The ECG preamplifier is powered by voltages 5 V and 5 V generated by the CPU board These power voltages are filtered by networks R4 C145 et R5 and C146 to generate the 5 VA and 5 VA voltages that pow
116. tching off the device with the On Off key The clock is driven by quartz Q21 with a speed of 32 768KHz Note The clock accuracy is greater than 30minutes per year The clock is powered by the backup cell or by the 3 3 V power supply depending on whether the device is on or off When the device is off the clock is powered by the backup cell via D37 R342 and LP1 Transistors Q29 and Q30 are blocked and stop the leakage current flowing to the 3 3 V power When the device is on the clock is powered by the 3 3 V supply as the voltage of the collector of Q29 is greater than the voltage of the anode of D37 Current flow from the cell to the clock is blocked Signal RTC_WATCH_DOG is an interrupt generated regularly by the clock It may be used by the ColdFire processor to monitor the progress of the program Note The clock also includes a voltage supervisor This function is not used Resistor R10 has not been fitted Part no 0 48 0029 5 10 May 2003 UBAT_FUSED_CPU A D CONVERTER HECK_BAT_VOLTAGE lt _ Power Battery Level Measurement CHECK_BAT_VOLTAGE UBAT_FUSED_CPU Start Stop Power Supplies Q22 Saving Battery Level Measurement LITH_BAT_VOLTAGE LITH_BAT_VOLTAGE lt _ DEFIBRILLATOR Detection Battery Insertion UBAT_FUSED_CPU KS Y D37 swaf Lithium Cell RIC lt _ONOFF_ANALYSE_KE MEMORISATION Auxiliary Powers gt U
117. ted by the CPU board which activates an analogue switch in the amplification circuit of signal ECG_LB in order to give rise to a rapid return of the ECG signal after a defibrillation shock Signal BACK_005HZ becomes active if the signal is exceeded the value of input signal INH_PACE is located between OV and 3 3V The signal is active when high active at 3 3V 10 Hz 10 Hz signal Logical signal generated by the CPU board to test the ECG acquisition circuit wnen the device is switched on by injecting a 10 Hz signal to the input stage of the ECG preamplifier While testing the ECG signal acquisition circuit the 10 Hz signal produces a square signal of approximately 10 Hz that oscillates between 5 V and 5 V When the 10 Hz signal is inactive itis 5 V gt the 10 Hz input signal oscillates from 5 V to 5 V during the acquisition circuit test Normally when the signal is inactive the 10 Hz signal is 5 V Part no 0 48 0029 5 43 May 2003 Technical description of boards Output signals of the ECG preamplifier ECG_DEFI ECG defibrillator Analogue signal corresponding to the patient ECG signal taken through the defibrillation electrodes Signal ECG_DEFI has a gain of about 180 as compared to the input signal gt signal ECG_DEFI is located between 5 V and 5 V at the most Z_ELEC DEFI Defibrillator Electrode Impedance Analogue signal where the amplitude is equal to the impedance connected between the two defibril
118. the defibrillation shock General description The IGBT control circuit actively blocks the IGBTs of the high voltage switching circuit during the charge preliminary charge completed and hold phases signals FPIB and SPIB The gates of the IGBTs in the high voltage unit are controlled by means of the pulse transmitters associated with the IGBTs The active blocking of IGBTs is controlled by the defibrillator control circuit signals PPG1 and PPG2 During the defibrillation shock phase the pulse biphasic waveform generation circuit is activated signal UPRA At the first pulse of the defibrillation wave current the IGBT control circuit supplies a synchronisation signal to the microcontroller of the defibrillator control circuit in order to measure the patient current signal RIPAT During the defibrillation shock the IGBT control circuit controls the IGBTS to generate the patient impedance compensated pulse biphasic waveform signals FPIC FPIB SPIC and SPIB Addressing signals PBSBO PBSB1 and PBSB2 generated by the defibrillator control circuit are used to select the databank that supplies the IGBT control signals depending on the patient resistance determined by the defibrillator circuit microcontroller Blocking of IGBTs during the charging and hold phases The IGBTs are blocked during the charge preliminary charge completed and hold phases by the two signals PPG1 and PPG2 generated by microcontroller U36 The two signals PPG1 an
119. the triggering of the safety latch when one of the relay activation transistors must conduct for over 2 5 s That also makes it possible to detect a short circuit in any of the two transistors or in both gt input signal DUFD is located between 0 and UBATT at the most IGFD IGBT Failure Detection Analogue signal that is equal to the differential potential between the mid points of the two branches of the H bridge The signal is amplified and its amplitude is compared to a reference limit Signal IGFD must lead to the triggering of the safety latch when the IGBTs of a branch of the H bridge is needed to conduct for over 1 5s That also makes it possible to detect any IGBT short circuit in the HV switching stage gt Signal IGFD is active when low active at 0 V Part no 0 48 0029 5 52 May 2003 Technical description of boards Output signals of the fault detection circuit FDUO Failure Discharge Unit Output Logical signal corresponding to the triggering of the safety latch The safety latch must be triggered voluntarily when the device is started up In order to check operation triggering takes place through signal SFDU If any hardware faults are found the fault latch is triggered by one of the input signals CHVM DUFD IGFD or SFDU When the latch is triggered signal FDUO is high gt output signal FDUO is active when high active at 5 V Part no 0 48 0029 5 53 May 2003 P1 WSM0008_PCB FRED EASY Circuit
120. tive blocking of the IGBTs After a 100 ms duration signal UPRA de activates the patient relay RL5 and RL6 and disables the IGBT control circuit Microcontroller U36 de activates all the outputs and signals EPDU WDRA and EHVG are switched to low leading to a safety discharge of the energy remaining in the HV capacitor During the defibrillation shock microcontroller U36 calculates the energy delivered to the patient and transmits the corresponding information to master microprocessor of the CPU board HV capacitor safety discharge The HV capacitor safety discharge may be initiated either directly by microcontroller U36 when it enters the safety discharge phase or a safety discharge command from the master microprocessor of the CPU board or by the fault detection circuit through the fault latch In all cases the safety discharge of the HV capacitor is triggered by the return to the low level of signal WDRA Part no 0 48 0029 5 35 May 2003 Technical description of boards High voltage circuit The high voltage circuit performs the following functions e Patient insulation from the high voltage circuit HV capacitor charging at the set energy value Measurement of the charge of the HV capacitor Blocking of the high voltage switching circuit Generation of the patient impedance compensated pulse biphasic waveform Measurement of the peak value of the defibrillation current HV capacitor safety discharge eeeeee General description of
121. trol circuit EPROM The signal is identical to signal FPIC The first pulse of signal RIPAT is used to synchronise microcontroller U36 for calculating the patient resistance at the first current pulse gt signal RIPAT is active when high active at 5 V FPIC First Phase IGBT Conducting Logical signal makes the phase 1 IGBTs conduct during the defibrillation shock This signal matches the content of the EPROM for the selected bank gt signal FPIC is active when high active at 5 V FPIB First Phase IGBT Conducting Logical signal that makes the phase 1 IGBTs block during the charge preliminary charge completed and hold phases and during the defibrillation shock This signal is either signal PPG1 or the content of the EPROM for the bank selected during the shock gt signal FPIB is active when high active at 5 V SPIC Second Phase IGBT Conducting Logical signal makes the phase 2 IGBTs conduct during the defibrillation shock This signal matches the content of the EPROM for the selected bank gt signal SPIC is active when high active at 5 V SPIB Second Phase IGBT Blocking Logical signal that makes the phase 2 IGBTs block during the charge preliminary charge completed and hold phases and during the defibrillation shock This signal is either signal PPG2 or the content of the EPROM for the bank selected during the shock gt signal SPIB is active when high active at 5 V Part no 0 48 0029 5 51 Ma
122. troller U36 activates signal EPDU which makes transistor Q5B conduct through open collector driver U33B In those conditions the defibrillation shock can be delivered to the patient The hold phase lasts no more than 20s after which microcontroller U36 triggers a safety discharge Measurement of the energy stored in the HV capacitor The energy stored in the HV capacitor is measured by two independent signals THVM and CHVM During the charging sequences the stored energy is measured by signal THVM Signal THVM comes from the primary winding of the HV converter After it is formed it corresponds to the charging voltage of the HV capacitor During the preliminary charging completed and hold phases the stored energy is measured by signal CHVM Signal CHVM is directly taken from the terminals of the HV capacitor through a resistive divider with a high ohm value and circuit U2A Triggering of a defibrillation shock If during the hold phase the Shock key of the device is pressed the defibrillator delivers the defibrillation shock When the Shock key is pressed signal SHOCK_KEY is connected to the ground When signal SHOCK_KEY is low patient relay RL5 and RL6 is excited by two independent control ways The first activation way of patient relay RL5 RL6 is made up of transistor Q6B and buffer U34C which are driven by signal UPRA generated by microcontroller U36 When the Shock key is pressed comparator U35A supplies the low level at the out
123. ual function It switches the device on and off and makes it possible to start an analysis The second function has been described in the section Starting an Analysis Pressing key S1 takes input KS of clock U9 24 to the ground through D2 That signal saved by latch U11A is transmitted to ColdFire through signal PUSH_BUTTON_POWER_ON It informs ColdFire of the origin of the starting of the device Latch U11A is reset by Q6 and signal CMD_FLASHING_LED_ON It is generated by ColdFire Signal INH1 keeps transistor Q6 blocked during the rest pulse duration and a few milliseconds after that in order to ensure the saving of signal ONOFF_ANALYSE_KEY That extension of the duration of signal INH1 beyond the reset is achieved by network R367 R368 and C199 The ONOFF_ANALYSE_KEY signal is transmitted and processed by the defibrillator microcontroller It has no bearing on the working of the defibrillator during the device start up phase The device is stopped by a lengthy press of the On Off_Analysis key Starting an analysis An analysis is started by pressing key S1 when the device is on The signal is transmitted to the defibrillator microcontroller Note If key S1 is kept pressed for more than three seconds the device is switched off The On Off_Analysis key is lit by two green LEDs D20 and D21 The lighting of the LEDs is controlled through transistors Q9 and Q10 and signal CMD LED ANALYSE generated by ColdFire Delivering a defibrillation
124. x distinct phases 1 Standby phase Phase during which FRED Easy is on monitoring function The defibrillator part is standing by no request for charging 2 Charging phase Phase during which the high voltage generator charges the high voltage capacitor 40uF 3 1KV The charging phase may be initiated by two different commands 1 Preliminary charging command 2 Charging command 3 Preliminary charging completed Phase following a preliminary charging order when the selected energy is reached During this phase defibrillation shocks cannot be administered 4 Hold phase Phase following a charging order when the selected energy is reached This phase lasts no more than 20 seconds during which the high voltage capacitor remains charged FRED Easy is ready to delivery the defibrillation shock 5 Shock phase This is when FRED easy delivers the patient impedance compensated pulse biphasic defibrillation shock 6 Safety discharge This is when the energy stored in the high voltage capacitor is discharged into an internal discharge circuit of FRED Easy ECG preamplifier The preamplifier part performs the following functions e ECG signal acquisition e Amplification and processing of the ECG signal e Verification of the acquisition chain e Patient impedance measurement General description of the ECG preamplifier On the defibrillator printed circuit the ECG preamplifier part is located under the two metal shields tha
125. ximise the use of machine power That is why the Status display is the only means of indication When the device is switched on again an error message indicates the problem found during periodic testing Each time the device is switched on the error message is displayed The error disappears when the problem is corrected and when new tests succeed after battery insertion If the tests are successful the device is switched off Specific case of battery insertion tests Given that periodic tests cannot be performed when the device no longer has a battery the device must be tested as soon as a new battery is inserted in order to indicate any fault as soon as possible Tests are triggered as soon as a battery is inserted in the device In that case the test and the operations performed are e Self tests if no error is found during previous periodic tests Self tests level 2 hardware test of the defibrillator module and ECG acquisition circuit tests if an error has been found during the previous periodic tests If any of the tested peripherals shows an error the device cannot be used In that case the device status display flashing LED is changed to indicate that the device may not be used the LED goes off and a message indicates the test that has failed Part no 0 48 0029 Page 2 2 May 2003 Testing and maintenance If the battery insertion test is successful and if the last logged periodic test has failed the battery i
126. y 2003 Technical description of boards 5 3 8 Fault detection circuit Input signals of the fault detection circuit SFDU Set Failure Detection Unit Logical signal from microcontroller U36 that triggers the safety latch when the device is switched on before the latch is tested by the microcontroller Signal SFDU is active for 5ms gt input signal SFDU is active when low active at OV RFDU Reset Failure Detection Unit Logical signal that direct resets the safety latch after it is tested when the device is switched on Signal RFDU is active for 5ms gt input signal RFDU is active when low active at OV CHVM Capacitor High Voltage Measurement Analogue signal offering the second way to measure the charge voltage of the HV capacitor This measurement is taken by means of a voltage divider with a high resistive value referenced to the ground Signal CHVM is applied by microcontroller U36 and transmitted by a serial link to the host CPU to display the stored energy corrected for 50Q The signal must also be used if there is any fault in charge stopping through FDU The maximum charge voltage must not exceed 3 4KV gt signal THVM is located between 0 and 4V at the most gt scale factor CHVM V U pr V 850 where U pr gt HV capacitor charge voltage DUFD Discharge Unit Failure Detection Analogue signal that corresponds to the mid point of the two patient relay activation transistors Signal DUFD must lead to

Download Pdf Manuals

image

Related Search

Related Contents

VERSAMED_I VENT 101_Manual ANVISApdf  Seer Preamplifier Manual  SIG-HC-86 CAM2 Multi-Vehicle Synthetic Blend ATF Rev01  TransCanada - Office national de l`énergie  Refrigeradores Bosch KSG34  "service manual"  Tarot 2-Axis T-2D Brushless Gimbal for GoPro Hero3 User Manual  DAVE - Quick® SpA  XGB Positioning    

Copyright © All rights reserved.
Failed to retrieve file