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Service manual Version 01.00

1. Schiler AG PAOLO oss be an CH 6340 Baar
2. R209 R205 TP39O C86 A175 deb Boos LS R202 ai Hiza S P21 uP Print G1 RSO LLL CHIEL ROSH Og CN FP166 o TPL2 ac RSI R92 d13d ts Project EASY PORT R220 Title P24 Q L e del c12 R238 R i JE Ra BR c3 T8 TPID o 000000 00000 0000 000 00000000000 0000000000 TPS TP780 S C41 deg u2387 P TP67 000000000000 o O OTP70 U21 Riz R14 15 TP69 Q C124 O Schiller AG Altgasse 68 D 262 C Visum Drawn By Gau Date 23 02 04 Sheet 2 of 2 CH 6340 Baar K C138 LM ES gs d lt p BL C136 gero o Sira ZK ap R153 B o CA R154 a lt C R155 EREN
3. DES uP Print Project EASY PORT Title iva 2202 Big BEER R248 H SRI eer oe 5 Katja Lo21 C aus U11 O lo A O I T6 8 ui C30 Oo Layout drawings 7 2 Defibrillator circuit 3 2628 0 48 0049 7 3 Avril 2004 Diagrams and layout drawings D2628BA 0 48 0049 7 4 Avril 2004 Schier AG DZOZSDA N s 68 oo
4. MEDICAL S 4 rue Louis Pasteur ZAE Sud BP50 67162 WISSEMBOURG CEDEX 0 48 0049 5 38 APRIL 2004 Technical description of boards R217 H V U_BAT_F_DEFI Converter C L tL pa c H V A Q6 TSE Multiplier 2 GND PATIENTI 17 5V O N AAA cL 4sur Defi um AV Electrodes PATIENT2 xl H V High Volt Generator eran ne 4 IGBT Module CSM 100 2 8 ag 2 8 ag PE GND GND GND GND GND SND ECG Preamplifier GENERAL_EN Patient Impedance END 8 7 IGBT OFF 5 SI Z T Measurement bj 2 2 z d 5 g E 5 R E 8 Z E Z PHASED DECOUP z amp 2 Ei z lei SES S s o al o gt gt gt High Voltage Defibrillator Capacitor Capacitor Patient IGBT Module 2 Generator Charging Voltage Voltage Current Control Signals Control Signals Control Measurement 2 Measurement 1 Measurement GN IGBT S2 S3 LEEN IGBT Failure Detection I 30KHZ Defibrillator Control Unit Z ERROR z a a Z E nl 2 VVV Smid a G to HOST CPU E E A Pi el g UE Schema No V Easy Port 2 Defibrillator High Voltage Unit WSM0040 SYN1 SCHILLER Serial Communication Project 100 FRED EASY PORT 2 eca No Date 220304 Vere with HOST CPU Size A3 Drawn by RH NF lart No WSMO040A
5. The various power supplies generated by the CPU board from voltage UBAT 12V lithium cell Voltage monitoring and Coldfire reset signal generation circuits On Off circuits On Off Analyse and Shock pushbuttons Shock and Electrode LEDs UBAT comes from the defibrillator board and powers the CPU board via the 26 pin flat cable The secondary voltages generated are supplied to the defibrillator board by the same flat cable Power supplies Voltage 3 3 VCC The 3 3 VCC power supply voltage is derived from the UBAT cell voltage by means of chopping regulator U12 chopping transistors U13A and U13B diode D4 induction coil L4 and capacitors C113 and C114 The components make up a step down regulator The voltage is controlled by resistor R266 Voltage 5 V The 5 V power supply voltage is derived from the cell voltage by means of chopping regulator U11 diode D2 induction coil L3 and capacitors C18 C111 and C116 The components make up a step down regulator The voltage is controlled by dividing bridge R159 R164 Voltage 5 VOP The 5 VOP voltage is 5 V filtered by L5 C19 and C112 and is particularly intended to supply power to the operational amplifiers Voltage 17 5 V The 17 5 V power supply voltage is derived from 5 V by means of a step up chopping regulator made up of U14 L7 D3 C82 C123 R162 R165 R166 3 3 V power supply voltage supervisor minimum voltage The 3 3 V power supply voltage supervisor is mad
6. 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 0 48 0019 Page V APRIL 2004 FRED EASYPORT PRECAUTIONS WHILE TESTING THE DEVICE While testing the FRED EASYPORT 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 0 48 0019 Page V APRIL 2004 FRED EASYPORT SOMMAIRE 1 Operation 1 1 Display and controls 1 2 Battery and minicard 1 3 Explanation of symbols used 1 4 Device operation 1 5 Defibrillation procedure 1 6 Recording optional 1 7 Technical specifications 2 Testing and maintenance 2 1 Functional testing 2 2 Test mode 2 3 SAAD mode 2 4 Systematic checking before use 2 5 Cleaning and disinfection 3 Troubleshooting 4 Replacement of parts 4 1 Device disassembly procedure 4 2 Working on the CPU circuit 4 3 Working on the defibrillator circuit 4 4 Replacing the HV capacitor 4 5 Reassembling the device 4 6 Replacing parts 5 Technical description of boards 5 1 FRED Easyport 5 2 CPU part no 3 2627 5 3 Defibrillator board part no 3 2628 6 Device modifications 6 1 Definition 6 2 CPU circuit 6 3 Defibrillator circuit 7 Diagrams and la
7. Cell unit Set up interface L o 8 MINIDIN7 10 O Set up and SI downloading goo interface Conn P2 Diagram 1 General diagram CPU CIRCUIT ADCPM decoder audio amplifier Diagram 6 ECG ADC analogue processing Diagram 7 LCD interface Diagram 5 CPU MCU Diagram 2 3 Connector Power RS232 external PC and Defi board Mini On Off SPI mini SD card SD Card pushbutton Serial communication Diagram 3 Diagram 4 conn JP1 The subassemblies of the CPU board have been described in diagrams 2 to 7 SPEAKER 0 48 0049 CPU FRED EASY PORT General diagram END SCHILLER _ Project PCE No Date notera T Size A3 Dramby JA No Sheet 1 of 7 Sanam 5 24 APRIL 2004 Technical description of boards Diagram 2 CPU MCU ColdFire Memory Clocks Clocks Logical functions CPU_CLK 0 22 C 1 A10PRECH Sheet 4 12 ap cs gt 3 3V CS 0 7 Bidirectional data buffer PWR_BUS BA 0 7 116 31 FLASH_BUSY RASO lt _ A10PRECHG lt _ L BUF DATA BUS BUF ADRS BUS Sheet 3 12 CS BUS CTRL BUS CLK BUS io BUS SERIAL BUS Buffered data bus Buffered address bus CS Chip Select bus Control bus WR
8. The ADPCM decoder U26 output AOUTL provides an analogue signal is applied to the audio amplification chain formed by U27A U27B and U28 Audio amplification The audio amplifier is built around circuit U28 Pre filtering is provided by U27B The audio signal is applied via a capacitive link C34 to the power amplifier input the output of which is applied to the speaker Power amplifier U28 may be put into standby mode by means of signal POWER DOWN AUX 0 48 0049 5 18 Avril 2004 Technical description of boards Analoque processing and analoque to digital converter Figure Diagram 7 represents the analogue processing functions and analogue to digital conversion The ADC U36 is controlled by Coldfire by means of data bus B_D 16 31 signals CS5 WE OE ADC_CSTART and clock CLK4MO96 Line INT4 EOC informs Coldfire that conversion is completed and that the converted data are available The converter resolution is 10 bits and its voltage reference VREF_2V5 is supplied by D20 The ADC has eight multiplexed analogue inputs CHO to CH7 which enable it to digitise the following signals CHO ECG ADC CH1 Z ELEC DEFI CH2 DELTA Z CH3 CHK BAT CPU Analogue signal from the defibrillator board It carries information from the ECG with a bandwidth at 3 dB of 0 5 Hz 23 Hz Before it is applied to the input of the ADC signal ECG_ADC is conditioned by the analogue processing function of the CPU board Analogue s
9. When the electrodes are not connected the device displays a message to inform the user that the electrodes are not connected or are poorly connected and that they need to be connected to the device The device remains in that state as long as the electrode problem persists If the problem lasts for 30 seconds the device guides the user to apply CPR After five minutes the device goes off automatically to save power The fault is also reported by a second visual indicator a LED located under the electrode connector When the fault is observed the LED lights up to report it Otherwise the LED is off To use the device the user is given visual and audio instructions display and loudspeaker Power is supplied by disposable plug in lithium cells Their capacity is sufficient for 70 shocks at the maximum power value or five hours of monitoring cyclical 30 minutes on 30 minutes off or five years of standing by 0 48 0049 Page 1 5 Avril 2004 Operation 1 5 Defibrillation procedure Allthe stages are explained to the user through voice prompts and are displayed on the screen When the D key is pressed an introductory text asks the user to stick on the electrodes The introductory text is repeated till FRED Easyport recognises that the adhesive electrodes have been applied After that FRED Easyport asks the user to start an ECG analysis and not touch the patient Note With the signals from the database of the
10. 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 authorised by SCHILLER MEDICAL the device is used in accordance with its instructions for use s 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 s The quality assurance system in use in the facilities of SCHILLER meets international standards EN ISO 9001 and ISO 13485 e Unless otherwise agreed in writing by SCHILLER no part of the manufacturer s literature may be duplicated or reproduced 0 48 0019 Page Ill APRIL 2004 FRED EASYPORT 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
11. Also follow the cable path Make sure that nothing has been forgotten before restarting the device Important This operation concerns a key component of the HV part of the device and may only be performed by specially authorised personnel with training in FRED Easyport A test of the energy delivered is required 0 48 0049 4 9 Avril 2004 Replacement of parts 4 5 Reassembling the device Reverse the operations to reassemble the device 1 Do not forget to connect the speaker to the CPU 2 Take care while connecting the HV contacts 4 6 Replacing parts d Parts may only be replaced by personnel who have been specially trained and authorised by Schiller Also use only original Schiller replacement parts Ee While ordering a new part from Schiller state the type of device and the serial number provided under the device Then specify the item code of the part to be replaced 0 48 0049 4 10 Avril 2004 Replacement of parts 2x Contact D fi 4 410 246 Boitier sup rieur 4 310 324 Gravure bo tier sup rieur 4 310 3 Protection carte SD 4 435 276 Touche MA _ 4 450 336 is 7 Haut parleur 3 940 001 ___ Touche analyse 4 450 337 Touche choc 4 450 335 6x Vis PT 2245 4910226 4A P Blindage 4416 120 Condensateur 4 812 105 Defi Print Defi blindage 4416 124 78x Vis PT 2245 4 910 226 m ECG Blindage 4 416 123
12. Bo tier inf rieur 4 310 324 x Vis PT 30x14 4910254 6x cache vis 4 430 210 Pack batterie Easyport Z Pos Menge Bezeichnung S Werkstot R T C H T Bemerung MMI E31 3 940 002 Allgememtolerancen SN 258440 m BG Zuordnung InvervorEasy pont 77 A jv 0 48 0049 Avril 2004 Technical description of boards 5 Technical description of boards 5 1 FRED Easyport General description of FRED Easyport FRED Easyport is technically divided into two subassemblies e The defibrillator board which carries the various digital processing functions specific to the defibrillator analogue processing functions and the high voltage circuit of the defibrillator e The CPU board which carries the various digital processing functions storage auxiliary power supplies and control monitoring and display systems The two boards communicate electrically with each other through a flat cable with a 26 pin connector at its end P2 Control monitoring power supply display and recording systems The various control monitoring and display systems of the CPU board are LCD screen that acts as the visual interface between FRED Easyport and the user On Off key for switching the device on and off Analyse key to start an analysis of the patient s ECG signal Shock key to deliver the defibrillation shock Orange LEDs showing the Shock key and providing an added visual user interface Electrode fault LED showing where the
13. Event recording 500 events e Capacit de la pile au lithium 70 chocs puissance maximale ou Utilisation du moniteur pendant 4 heures cyclique 30 minutes en marche 30 min arr t 5 ans de veille e Lithium battery capacity 70 shocks atthe maximum power rating or Use of the monitor for four hours cyclical 30 minutes on 30 minutes off Five years standing by e Environment conditions Transport storage Temperature 20 to 50 C Relative humidity of air 0 to 95 96 non condensing Atmospheric pressure 500 1060 hPa Use Temperature 0 to 50 C Relative humidity of air 0 to 95 96 non condensing Atmospheric pressure 500 1060 hPa e 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 LS e Dimensions and weight Width 126 mm Depth 133 mm Height 35 mm Approximate weight 490 g with battery 0 48 0049 Page 1 10 Avril 2004 Testing and maintenance 2 Testing and maintenance This section describes the test and maintenance procedures recommended for p
14. LED stays on CPU board fault Replace CPU board No voice prompts Speaker fault Replace speaker CPU board fault Replace CPU board Orange Shock key will not light up CPU board fault Replace CPU board No memory card recording Memory card fault Replace memory card CPU board fault Replace CPU board Loss of date and time Button cell fault Replace button cell CPU board fault Replace CPU board 0 48 0049 Page 3 1 Avril 2004 Troubleshooting If any error is detected FRED Easyport will indicate the error code and the screen will be as shown below To identify the error refer to the table below or use the FredCo software DEVICE OUT OF ORDER If an error message is displayed note down the error number and restart the device to make sure that the error is not due to an isolated program error List of error messages CODE MESSAGE POSSIBLE CAUSES CORRECTIVE ACTION Defi board problem Replace CPU board CPU board CPU board CPU board CPU board board not compatible hardware board not compatible software Defi board Or replace Defi board at U7 of Defi board board Or replace Defi board board 100 207 Err Defi security discharge Safety discharge circuit Replace Defi board problem on Defi board U6 R127 D17 D19 board Or replace Defi board 0 48 0049 Page 3 2 Avril 2004 Troubleshooting List of error messages 100 209 Err Defi shock button Shock button problem Check
15. and replace Shock Or U8 problem button if needed Or replace Defi board board Or replace Defi board 100 211 Err Defi Discharge HV reset Problem with HV circuit Replace Defi board stored on Defi board on Defi board energy on Defi board 100 215 Err Defi battery voltage Problem with lithium cell Replace cell board Or replace Defi r board board Or replace Defi board U3 on Defi board 100 221 Err Defi problem IGBT Problem with IGBT Replace Defi board module U6 on Defi board power supply Or replace CPU board 100 300 Err LCD Problem with LCD Replace CPU board management on CPU board on CPU board on CPU board 100 501 Err Read Flash Problem with Flash Replace CPU board reading U6 on CPU board 100 502 Err Write flash Problem with Flash Replace CPU board writing U6 on CPU board U16 on CPU board 100 700 Err Hardware version Hard and software Load correct software version not compatible on version CPU board Or Upgrade CPU board board CPU board 100 702 Err Hw version invalid gt 47 Problem on R82 of CPU Check R2 on CPU board it board must adjust to the hardware version 100 800 Err Standalone mode Problem with PB15 at Check if LP1 is not shorted U1 of CPU board Or check if pin 4 of P1 is connected to the ground not connected to the ground 100 900 Err ECG amplification chain Problem with ECG Replace CPU board amplification chain on And or repla
16. defibrillation electrodes are to be connected It also shows electrical circuit continuity A speaker to play the prompts intended for the user s A removable memory card of the mini SD card type for recording the ECG signal and procedure events Set up and downloading accessory e A special unit that replaces the cell unit and has a mini DIN connector for a serial link with an external PC is used to download programs and set up FRED Easyport During these operations the device is powered by an external power source through the same connector 0 48 0049 5 12 Avril 2004 Technical description of boards 5 2 CPU part no 3 2627 The paragraphs below describe the different functions of the CPU board General description Figure Diagram 1 provides an overview of device functions The various subassemblies are represented in charts 2 to 7 The pushbuttons and the LCD display module are directly soldered onto the CPU board The CPU board controls and monitors the following basic functions Main clock Generation of intermediate clocks Real time clock Data bus amplification Address bus amplification SDRAM working memory Flash memory program set up data incident log Power from the 26 pin P2 connector for flat cable Auxiliary power supplies 3 3 V voltage supervisor Coldfire power supply Monitoring of auxiliary voltages Monitoring of power supply cell voltage Device power on off On Off key Start of analysis Ana
17. impedance When the patient impedance has been determined the microcontroller generates the waveform with a cyclical ratio adapted to the patient impedance by means of signals PH1_EN PH1 PH2_EN and PH2 When the pulsed biphasic defibrillation pulse is generated the microcontroller blocks IGBT S1 and makes S6 conduct the energy remaining in the HV capacitor is not dissipated in the safety discharge circuit after the shock During a defibrillation shock the microcontroller calculates the energy delivered and transmits that value and the peak current and patient impedance to the CPU board HIGH VOLTAGE CIRCUIT The high voltage circuit part performs the following functions Patient insulation from the high voltage circuit Charging the HV capacitor to the set energy Measurement of the HV capacitor charge voltage Generation of the patient impedance compensated pulsed biphasic waveform Measurement of the peak value of the defibrillation current HV capacitor safety discharge GENERAL DESCRIPTION The high voltage circuit insulates the patient from the high voltage unit of the defibrillator by means of IGBT S1 of the IGBT module The defibrillator charge circuit is directly powered by the lithium cell via the Charge transistor signal ON OFF CONV The HV capacitor is charged by the HV generator signal START_CHARGE When the HV capacitor is being charged IGBT S1 patient insulation is blocked and IGBT S6 safety discharge is saturated Durin
18. latch U22 The other control signals LCD_CS LCD_RS LCD_RES are derived from the data bus by means of latch U22 The power for the logical functions of the LCD screen is provided by the 3 3 V power supply via R143 A second power source VLCD is obtained from the 17 5 V power supply and linear regulator U24 VLCD is temperature compensated by thermistor R219 which offers optimum contrast regardless of the ambient temperature All the logical links with the LCD screen are filtered by RC networks Back lighting is provided by 4 white LEDs controlled by latch U22 through Q4 Hardware configuration Some particular options may be put in place by solder spots LP6 to LP10 The hardware configuration is read by means of input latch U21 Five entries of the latch are connected to VCC by pull up resistors R151 to R155 and may be forced to zero Input latch U21 is controlled by Coldfire by means of the data bus B_D 24 31 and signals CS1 and OE via logical door U20A Latch D21 also enables direct reading by Coldfire of the status of keys Analyse S2 and Shock S3 Audio functions Figure Diagram 6 represents the audio interface ADPCM decoder The ADPCM decoder is controlled by Coldfire through data bus B_D 16 31 and status control signals CS2 OE WE BAO RSTO and OKI_FIFO_MID The decoder operating frequency is 4 096 MHz It is achieved by the generation function of the intermediate clocks that is built around U10
19. list of data stored below is not exhaustive and will develop to keep pace with needs Total device running time Status of the mini SD card flash memory card size space occupied number of events logged Periodic test log last 30 tests as a minimum date time result description of the error Uncontrolled switching off last 30 times as a minimum cell low electrode fault for more than 5 minutes date and time Number of charges per energy value Number of shocks per energy value Total running time of the high voltage converter Etc The data cannot be erased by means of a device button They may be erased by a command from the serial link The data need to be made secure In particular they must not be destroyed when the device is switched off suddenly because the cell is removed The data are only saved when the device undergoes a controlled shut down 2 3 3 Downloading The downloading function is used to upgrade the firmware in the device The software provides the language To change languages the firmware with the required language needs to be downloaded 0 48 0049 Page 2 3 Avril 2004 Testing and maintenance 2 4 Systematic checking before use Before each use the device must undergo a visual inspection including the cables connectors and electrodes If a fault or malfunctioning likely to harm the safety of the patient or the user is found the device may not be started up again before it is repaired Syste
20. of parts 4 1 Device disassembly procedure While disassembling the device follow the instructions below 1 Remove the lithium cell from its housing 2 Disconnect the electrode cable 3 Turn the device over LCD screen down take off the protective caps on the screws and unscrew the six assembly screws of the upper and lower halves of the housing 4 After removing the six screws turn the device over once again LCD screen toward you 5 The upper half of the housing may now be pulled off gently The electrode connections to the left hand side may offer some resistance 6 Disconnect the flat cable connector 9O00 OO00257 Flat cable Electrode connections 0 48 0049 4 5 Avril 2004 Replacement of parts 4 2 Working on the CPU circuit To remove the CPU follow the instructions below 1 Disconnect the speaker and take off the six screws shown by an arrow Disconnect ccs vu iis idm w Important Do not lose the control button caps placed in the upper part 2 The speaker is glued into its slot If needed prise it out with a screwdriver 0 48 0049 4 6 Avril 2004 Replacement of parts Important This circuit contains components sensitive to electrostatic discharge The operation above shall be performed in accordance with ESD rules 3 To replace the button cell you will need to remove the shielding 0 010 010 010 0100010010001010 010 OI010
21. signals The defibrillator board provides two signals ECG_DEFI and ECG_STIM ECG DEFI undergoes preliminary filtering on the defibrillator board It is used to analyse the ECG but cannot be used for extracting pacing pulses ECG_STIM is less filtered for high frequencies and is used for that purpose The operational amplifiers are powered between 5 V and GND a virtual ground V_GND 2 V is created by U34A Analogue processing of signal ECG DEFI The continuous component of analogue signal ECG_DEFI undergoes ultimate filtration amplification and offsetting before it is digitised by the ADC Signal ECG_DEFI is applied to analogue switch U29 which is responsible for opening the amplification chain when a pacing pulse is detected Such opening is controlled by signal INHIB_PACE At the switch output the signal is applied to follower U30A through a capacitive link made up of R167 and C96 the object of which is to eliminate the continuous component of signal ECG_DEFI U30B is an inverter gain 1 and has no effect on the shape of the signal The gain is adjusted by R160 and R203 around U34B The continuous component is set to 1 25 V by R6 and R7 to be compatible with the input dynamics of the ADC C47 and C147 adjust the upper cut off frequency Analogue processing of signal ECG STIM Pace information is extracted from signal ECG_DEFI by means of the amplification and filtration chain made up of U32A U32B and U31B The output o
22. through the adhesive defibrillation electrodes e Defibrillator control circuit The defibrillator control circuit is responsible for controlling the charge of the HV capacitor and the defibrillation shock e High voltage circuit and HV capacitor The high voltage circuit charges and discharges the HV capacitor and measures the charging voltage and the patient current during the defibrillation shock e IGBT control circuit The IGBT control circuit controls the IGBT transistors of the high voltage unit in order to generate a patient impedance compensated pulsed biphasic waveform OPERATING OF THE DEFIBRILLATOR SECTION GENERAL DESCRIPTION The defibrillator circuit has four connectors one connector 2 high voltage contacts for connecting the adhesive electrodes one connector 5 contacts for connection with the lithium cell one connector 26 contacts for connection with the CPU board one connector 5 contacts for programming the uC of the defibrillator circuit The power circuit of the defibrillator part that is used to charge the HV capacitor is directly powered by the lithium cell protected by a fuse voltage U BAT F DEFI The defibrillator control circuits and the ECG preamplifier part are powered by 5 V voltage generated on the CPU board The IGBT control circuit is also powered by the 5 V voltage and by 17 5 V generated on the CPU board The voltage references used by the defibrillator part are generated locally in the defibrilla
23. weak not flickering Memorizing in progress with progressively incremented with 24 the filling not flickering 99 Almost full memory threshold with 98 filling flickering Problem memory card Adult electrode detected Child electrode detected Time since the machine was started up minutes and seconds X 0 48 0049 Page 1 3 Avril 2004 Operation 1 4 Device operation FRED Easyport is programmed to operate in four different modes the test mode followed by the defibrillator mode the SAAD mode for device configuration and the Standalone mode used by Manufacturing e Test mode When the device is powered by a cell it runs a self test every time it is started up If it does not find any fault and is ready to operate it switches to the Defibrillator mode e Defibrillator mode or Nominal mode When the device is powered by a cell and has passed the self tests it switches to the defibrillator mode In this operating mode the device performs the following operations Resuscitation algorithm ERC protocol Saving of data throughout the procedure Monitoring of system and physiological parameters Illustration of the screen in nominal mode Date and time 15 01 04 16 54 B 24 PRESS THE Messages GREEN BUTTON e SAAD Setup Acquisition Adjustment Downloading mode When the device is powered by an adapter unit connected to th
24. 10101010101010101010 IGALEP2 EU TMU 16 01 04 0 48 0049 4 7 Avril 2004 Replacement of parts 4 3 Working on the defibrillator circuit To remove the defibrillator circuit 1 Take off the six screws marked by an arrow 2 Take off the bracket that holds the cell connector Bracket Important This circuit contains components sensitive to electrostatic discharge After disconnecting the PCB from the device follow ESD rules 0 48 0049 4 8 Avril 2004 Replacement of parts 4 4 Replacing the HV capacitor d This operation concerns the HV capacitor which may be charged to a fatal voltage Before any work make sure that the HV capacitor has been fully discharged Never touch the terminals of the HV capacitor directly The HV capacitor may only be replaced by specially authorised and trained personnel The replacement of the HV capacitor is required very rarely as the life of the capacitor is extremely long However if needed the HV capacitor may be replaced in accordance with the instructions below IMPORTANT FIRST CHECK IF THE HV CAPACITOR IS FULLY DISCHARGED 1 Separate the two HV wires 2628BA 00006 me w B B EM lli L After you remove the fully discharged HV capacitor from the lower part short its two terminals with conductive wire While replacing the HV capacitor place it in its housing and then solder the cables taking care to follow the polarity
25. 2 4 Avril 2004 Troubleshooting 3 Troubleshooting This section describes how to locate failures if FRED Easyport shows any signs of malfunctioning If you have trouble locating or correcting the fault contact the after sales service department of Schiller Precautions to be taken for troubleshooting All tests with FRED Easyport defibrillators shall be done exclusively with fixed resistors with high voltage and power ratings to simulate the patient The resistors shall be correctly insulated from the ground and the earth Any use of incorrectly insulated systems or systems with loose contacts or containing components such as spark gaps or electronic flash lamps is strictly forbidden as that could irreversibly damage the device HV CAPACITOR HAS BEEN DISCHARGED FULLY ERROR OBSERVATION POSSIBLE CAUSES CORRECTIVE ACTION III TESTING Not displayed on the screen 1 Check button cell on Replace button cell CPU out of order or flat 2 Check if F1 fault on Replace fuse Defibrillator board 3 CPU board fault Replace CPU 4 Defibrillator board fault Replace defibrillator board d Before opening the device for work FIRST MAKE SURE THAT THE Electrodes not connected and LED under the Defibrillator board fault Replace defibrillator board electrode connector off CPU board fault Replace CPU board Electrodes connected to simulator with 50 ohm Defibrillator board fault Replace defibrillator board impedance but the
26. 4 white LEDs are used to backlight the LCD s 2 orange LEDs illuminate the Shock button when it is valid Shock ready e 1 LED indicates electrode faults patient not connected 0 48 0049 5 16 Avril 2004 Technical description of boards Serial links Figure Diagram 4 represents the three serial links used by FRED Easyport e Serial link to an external PC e Serial link to the defibrillator board e SPI link to the Mini SD Card memory card Serial communication with external PC The serial link RS232 protocol TTL levels through the battery connector JP5 is used essentially for operations involving upgrades of the device program and set up It enables communication between an external PC and Coldfire It operates at 115 2 kbauds A special adapting connector of the size of a battery unit fitted with a mini DIN connector is used to set up a physical link between FRED Easyport and the downloading device Special software FredCo is required for using the data from the serial link During the set up and or download operations the device must also be powered by means of the connector Note Pin EXT_PWR is connected to U_BAT through the adapter unit It enables the software of FRED Easyport to switch automatically to the set up mode Serial communication between Coldfire and the PIC microcontroller of the defibrillator Serial communication between Coldfire and the PIC microcontroller of the defibrillator takes place through a
27. ADC CSTART ANALYSE KEY BA O 7 BCLKT BD_CS B D 16 31 BDM CPU CLK BKPT BLOCK_PACE Description Coldfire address bus SDRAM control signal ADC conversion starting Signal resulting from the activation of the Shock key Active when low Amplified address bus Synchronisation signal Data bus buffer command signal Amplified data bus Signal of port BDM and JTAG Not involved in device operation Signal of port BDM and JTAG Not involved in device operation Amplification chain analogue switch opening command to remove the pacing pulse Active when low BS 0 3 Control signal of the transfer of data between the SDRAM and Coldfire CASO SDRAM control signal CHOC_KEY Signal resulting from the activation of the Shock key Active when low CHK_BAT_DEF Signal from the defibrillator board for measuring the voltage during the charge CHK_EXT_PWR Signal for selecting the downloading and set up mode CLK4MO96 4 096 MHz secondary clock CPU_CLK 40 96 MHz primary clock CMD LED CHOC CMD LED ELECTRODE CMD OFF Shock key LED control signal Adhesive electrode input LED control signal Pulsed signal generated by Coldfire The device is shut down when this signal is absent CS 0 7 Bus made up of different CSs CS0 Flash memory addressing U6 CS1 CONFIG and LCD latch addressing U21 and U22 CS2 ADPCM decoder addressing U26 CS3 RTC clock addressing U16 CS4 Addressing of data latches of LCD U23 a
28. AHA American Heart Association FRED Easyport offers precise detection with 98 4 sensitivity and 99 8 specificity The device can be set up so that it automatically starts an ECG analysis During the analysis phase the software controls the capacitor charge with an energy value equal to that of the first shock Ifthe analysis program recognises a heart rate that calls for defibrillation the device asks for a shock The heart disorders that call for defibrillation are ventricular fibrillation or ventricular tachycardia with a rate of over 180 bpm If the device recognises a heart rate that calls for defibrillation defibrillation is only permitted if the patient has been found earlier to have no pulse or show no signs of circulation A second analysis is triggered automatically with a preliminary capacitor charge to the energy value of the first shock If the first defibrillation shock has no effect the device automatically tops up the charge in the capacitor to the energy required for a second shock A third analysis is triggered automatically with a preliminary capacitor charge to the energy value of the second shock If the second defibrillation shock has no effect the device automatically tops up the charge in the capacitor to the energy required for a third shock Note The energy values set by default as follows the technical assistance department of Schiller can set other default values Shock Adult
29. Child 1 90 J 15J 2 90 J 30 J 3 120 J 50 J If the third shock has no effect FRED Easyport asks the user to alternately apply artificial respiration and heart massage After one minute it will recommend a ECG analysis Depending on the set up the new analysis may be automatic After a successful defibrillation shock FRED Easyport asks the user to check the respiration and blood circulation of the patient If there are no signs of circulation the device recommends the alternate application of artificial respiration and heart message If there are signs of circulation the patient is to be laid on his or her side 0 48 0049 Page 1 6 Avril 2004 Operation If the analysis program does not recognise a heart rate that calls for defibrillation FRED Easyport informs the user that no defibrillation shock is required and asks the user to check respiration and signs of circulation If there is no sign of circulation FRED Easyport asks the user to alternately apply artificial respiration and heart massage Ifthere are signs of circulation the user is asked to lay the patient on his or her side After a minute FRED Easyport will ask for an ECG analysis once again Depending on the set up the new analysis may be automatic The values below may be set up by the technical assistance department of Schiller upon starting up introductory text or immediate request to apply the adhesive electrodes voice volume energy level
30. LLATOR CONTROL CIRCUIT The defibrillator control circuit performs the following functions Defibrillator section self test Transfer of data by serial link to the CPU board HV capacitor charge control Measurement of the energy stored by the HV capacitor Triggering of the defibrillation shock if the shock key is pressed Control of the IGBT module to generate the patient impedance compensated pulse biphasic waveform e Determination of patient resistance during the defibrillation shock e Safety discharge of the HV capacitor GENERAL DESCRIPTION The defibrillator control circuit contains a microcontroller that performs all the functions described above When the device is powered up the defibrillator control circuit runs a self test of the defibrillator section The defibrillator control circuit microcontroller transmits the data to the CPU board by means of a serial link During the AED protocol the defibrillator control circuit microcontroller checks if the Analyse key is pressed signal ANALYSE_KEY and transmits the corresponding information through the serial link to the CPU board If VF VT is recognised by the master microprocessor of the CPU board it sends a request for a preliminary charge and the selected energy value via the serial link Before triggering the HV capacitor charge the defibrillator control circuit microcontroller checks the operating of the Charge transistor through signal CHK_BAT_DEF When the test is completed the d
31. OE RSTO Clocks Miscellaneous in outputs RS232 serial links CPU FRED EASY PORT CPU MCU Project PCB No Size A3 Drawn by Art No Schema No Date Sheet 2 of 7 SCHILLER MEDICAL S A S 4 rue Louis Pasteur ZAE Sud BP50 67162 WISSEMBOURG CEDEX 0 48 0049 5 25 APRIL 2004 Technical description of boards Diagram 3 On Off Power supplies Pushbuttons LEDs Main switch Pushbuttons and LEDs ht UBAT_SWITCHED C U15 ON OFF Fuse EMC filtering E UBAT_FUSED_CPU D CMD_OFF p PROG ON SUDLED cH00 F gt CMD_LED_ELECTRODE a 4 Z 7 LED 7 LED Electrode Shock ANALYSE KEY C CHOC KEY C UM Burton Button Type ELECTR CN E ON OFF 4 ANALYSE EL ON OFF KEY C 12 V cell voltage via flat cable jets Sheet 7 12 9 9 9 Sheet 6 12 Power supplies CR2032 VREF gt UBAT SWITCHED Sheet 6 12 Power supply management RESET management PF RESET x To ColdFire To latchs LCD ANALYSE KEY gt sn CHOC_KEY gt TYPE_ELECTR gt PWR_BUS gt contains the following power supplies 3 3 V ColdFire and device power supply Vcc 5 V Audio amplifier power supply 5 VOP Filtered power supply for operational amplifiers 17 5 V Power supply used on Defi board IGBTs and HV converter control VbAux Pow
32. OUP which control the IGBTs S4 and S5 of the bridge H which are referenced to the ground With the first defibrillation waveform 0 48 0049 5 33 APRIL 2004 Technical description of boards current pulse the high voltage circuit measures the value of the patient current signal V_IPAT This information is used by the microcontroller to determine the patient impedance in order to control the IGBT control circuit All the control signals required to generate the pulsed biphasic waveform are directly supplied by the microcontroller which adapts the cyclical ratio of the pulses to the patient impedance The high voltage circuit is also used for the safety discharge of the HV capacitor by means of the IGBT module IGBTs S1 and S6 and a power resistor The safety discharge is only possible when S1 and S6 conduct simultaneously The IGBTs are controlled by the microcontroller The safety discharge may be initiated either directly by the defibrillator circuit microcontroller or by a signal sent via the serial link by the CPU board IGBT CONTROL CIRCUIT The IGBT control circuit performs the following functions e Blocking the IGBTs during the charge and hold phases S6 conducts e Commanding the IGBTs to generate the patient impedance compensated pulsed biphasic waveform during the defibrillation shock GENERAL DESCRIPTION The IGBT control circuit blocks the IGBTs S1 S2 S3 S4 and S5 of the module and makes IGBT S6 conduct during the cha
33. P ECG STIM 19 ECG STIM P Z_ELEC_DEFI 20 Z ELEC DEMI PREAMPLIFIER Z_ERROR gt vref Supply z p rs a d k x x UBATT U BAT F DEFI N FL 1 75V BAT 26 Hof L 25 r CHE BAT DEF CHK BAT DEF E E 2 SEEING v S gt 13 CHARGING CHARGING x 14 VIPAT Vref_Supply DJ mm U BAT E DEFI PATIENT J VIPAT Vref 4 096 O3 E CHARGING 17 5V v_HVv2 V_HV1 Vref_HVCONV J Vie HVCONV Vref_HVCONV 22 CHK BAT DEF n ON OFF CONV C oe ON_OFF_CONV PATIENT2 4 ad Z ERROR START CHARGE IA START CHARG ST RT_CHARGE 180 N STOP CHARGE II E ARG STOP_CHARGE 23 TYPE ELECTR TYPE ELECTR HIGHT VOLTAGE 6 ANALYSE KEY ANALYSE KEY CHOC KEY 6 5 FUE CIRCUIT 8 TXD DEFI 9 RXD DEFI CSM 100 164 xD PC GENERALEN Rs EN IGBT S1 EI ATQ EXD PC SBT S 150 EXT PAR enr oFF DJ IGBT OFF L IGBT_OFF PHASE1_EN C Lenie PHASE EN IGBT S2 PHASE1 DECOUP C FHASEL DECOUP PHASE1_DECOUP IGBT S5 PHASE2 EN E Oe m PHASE2 EN DJ gt PHASE2 EN GBT S DEFIBRILLATOR 5 gt N PHASE2_DECOUP PHASE DECOUP gt PHASE2 DECOUP IGBT S4 V_CRTL_IGBT C JP5 IN CONTROL ag EXT PWR CIRCUIT DECH INT C DECH INT DECH INT IGBT S6 Lithium Cell ac RD PC Connector a0 DPC IGBT CONTROL 5 D UBATT DEFAULT DETECTION V CRTLIeBT C el TST CIRCUIT UP Schema No Synoptique Easy Port 2 Defibrillator WSMO040 SYNO Project 100 FRED EASY PORT 2 PCB No Date 19 03 04 Size A3 Drawn by RH NF Art No WSM0040A Sheet 1 of 1 SCHILLER
34. SCHILLER MEDICAL S A S FRED easyport Semiautomatic defibrillator PAD Service manual Version 01 00 SCHILLER MEDICAL S A S ZAE SUD 4 rue Louis pasteur BP 90050 F 67162 WISSEMBOURG CEDEX T l phone 33 0 3 88 63 36 00 T l copie 33 0 3 88 94 12 82 Internet http www schiller medical com E mail info schiller fr THE ART OF DIAGNOSTICS Part No 0 48 0049 FRED EASYPORT Revision history of the service manual Version 01 00 April 2004 0 48 0019 Page I APRIL 2004 FRED EASYPORT 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 EASYPORT 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 manua
35. Sheet 2 of 2 6162 WISSEMBOURG CEDEX 0 48 0049 5 39 APRIL 2004 Device modifications 6 Device modifications 6 1 Definition ECL The ECL is the two digit revision number PN ofthe card P Card version number which is incremented every time the card is rerouted N Incremented with each modification on the card N is reset to A when the P version changes HARDWARE VERSION Digit incremented with each card change which may be recognised by the software as an electronic system present on the cards makes it possible to adjust a resistor and define a voltage limit that is converted by the device into a hardware version There are 46 card possibilities 1 46 On the CPU board resistor R81 must be adjusted On the defibrillator board resistor R163 must be adjusted 6 2 CPU circuit Version 1 3 2627 First manufactured card version R81 3 3 M 6 3 Defibrillator circuit Version 1 3 2628 First manufactured card version R164 33M 0 48 0049 6 1 Avril 2004 Layout drawings 7 Layout drawings 7 1 CPU circuit 3 2627 0 48 0049 7 1 Avril 2004 Diagrams and layout drawings D2627CA 0 48 0049 7 2 Avril 2004 Schiller AG Altgasse 68 D 262 C Visum Drawn By Gau Date 23 02 04 Sheet 1 of 2 CH 6340 Baar o p R143 CZSHIEO C28
36. arge request to the defibrillator circuit this time The defibrillator control circuit activates the HT generator signals ON_OFF_CONV and START_CHARGE till the new selected energy is reached When the energy stored in the HV capacitor is equal to the energy selected the microcontroller stops the HV generator signal STOP_CHARGE and authorises the defibrillation shock The defibrillator is in the hold phase during which the stored energy is measured by signal V_HV2 During the hold phase which may last 20 seconds at the most pressing the Shock key signal CHOC_KEY directly interconnected to the defibrillator circuit triggers the defibrillation shock by means of two different signals The first shock delivery signal is made up of the signal directly from the Shock key signal SHOCK_EN1 The second defibrillation shock triggering signal is signal SHOCK_EN2 generated by the defibrillator control circuit microcontroller when the Shock key is pressed The signal duration is approximately 12 ms The two signals above are used to validate the control signals of the IGBT module for the two phases of the defibrillation shock When a press on the Shock key is taken into account the microcontroller generates the first shock pulse after a 40 ms delay in order to ensure that IGBT S1 is conducting and S6 is correctly blocked During the first pulse the microcontroller measures the defibrillation current by means of signal V_IPAT in order to determine the patient
37. ator test communication channel and defibrillation hardware module Settings storage memory test Real time device clock test Cell voltage test The cell voltage is tested by charging the capacitor LCD display test Voice prompt system test Note Failure to pass tests 1 4 disables the device which indicates the failed test till it is Switched off Failure to pass tests 5 and 6 does not disable the device Simultaneous failure to pass tests 7 and 8 disables the device If the tests are passed or if the errors are not of the disabling type the device goes into Defibrillator mode 2 3 SAAD mode This operating mode is used to set up the device extract statistics or download software The cell is replaced by the adapter unit and the downloading unit connected to the FredCo software is to be used 2 3 1 Setting up and adjustments The configurable settings are Date and time format summer winter time gt Date format DD MM YYYY or MM DD YYYY or YYYY MM DD gt Time format 12 or 24 hours Defibrillation energy values ECG display Voice prompt volume level Analyse button use CPR phase Motion detection Language for the display and audio messages of the ERC protocol Device serial number Hardware version number Shock counter charge capacitor wear ERC 1 minute 3 minute protocol selection Device identification string 0 48 0049 Page 2 2 Avril 2004 Testing and maintenance 2 3 2 Statistics The
38. ce Defi board Defi board or CPU board 0 48 0049 Page 3 3 Avril 2004 Replacement of parts 4 Replacement of parts This section addresses the dismantling of FRED Easyport for replacing defective parts The warnings below apply to all work on the components inside the device d Danger FRED Easyport is a defibrillator with an HV capacitor capable of carrying fatal voltages The device may only be dismantled by specially authorised and trained personnel Before opening the device to work on it MAKE SURE THAT THE CAPACITOR HAS BEEN DISCHARGED w Important Before opening the device take the cell out of its housing Important The device contains circuits sensitive to electrostatic discharge All work on FRED Easyport shall be performed in accordance with ESD rules The work shall be performed on an antistatic mat connected to the earth and the operator shall wear an antistatic strap that is connected to the mat Remove the antistatic strap while working on the high voltage part of the defibrillator Important Each defibrillator and CPU board has its own hardware number The list of permitted combinations defibrillator and CPU hardware number is available from Schiller Medical The hardware version numbers are displayed when the device is started up during the self test phase Important Every time the device is opened it must undergo an overall test when it is closed 0 48 0049 4 4 Avril 2004 Replacement
39. e after the self test phase of the defibrillator circuit if the CPU host selects a 0 J energy value if the PIC detects that the cell is low during the charge phase UBATT lt 7 5V if the energy stored during the hold phase does not match the energy selected when the device is switched off or when the cell is removed during operation e The shock is delivered with single use adhesive electrodes applied in the anterior anterior lateral positions s BF type defibrillation electrode connector 0 48 0049 Page 1 9 Avril 2004 Operation e Defibrillation electrodes Adult electrodes Active area 50 cm Child electrodes Active area 15 cm Electrode cable length 1 20 m e VT VF recognition Shock recommendation for VF and VT VT 180 bpm Sensitivity 98 4 96 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 0 15 mV signals of 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 e Display LCD 60 x 40 mm high definition with EL backlighting display of text and icons e Recording of the use of the device optional ECG recording half an hour
40. e FredCo software by means of the serial link and is switched on it goes into SAAD mode This mode is used to Set up and adjust the device View statistics View logs events describing the use of the device Download new software versions e Standalone mode Manufacturing This mode is specific to the manufacturing department of Schiller and is used to test the CPU board by itself Connector P1 of the CPU board must be connected to the serial link of a test console and pin 4 of P1 must be connected to the ground When the device is in Standalone mode a message is displayed to inform the operator that the device is not ready for defibrillation Pressing the keys has no effect including the On Off button 0 48 0049 Page 1 4 Avril 2004 Operation Diagram of the operating modes External power C weon D Pin at ground External power Battery power STANDALONE Modus TEST Modus C A R T Modus Test without errors DEFIBRILLATOR Modus In the Defibrillator mode or nominal mode FRED Easyport is a cell operated automated external defibrillator that provides biphasic defibrillation waveforms Defibrillation is done by means of disposable adhesive electrodes through which the ECG signals required for the analysis are also collected Adhesive electrodes are available in child and adult versions The device recognises the type of electrode applied and selects the appropriate defibrillation energy levels accordingly
41. e up of circuit U18 It provides the RESET_PF pulse when the device is started up and monitors the 3 3 V power supply voltage during operation A drop below 3 V triggers a Coldfire reset pulse U_BAT SWITCHED 3 3V 5V 17 5 V voltage supervisor U17 resets the CPU if any over voltage is seen at the 3 3 V 5 V or 17 5 V power supplies or if voltage U_BAT_SWITCHED drops below 6 5 V Note During normal operation the cell voltage is monitored by Coldfire and by the PIC If there is a fault an error message is generated and the user is informed if the cell voltage is too low to correctly power FRED Easyport The 6 5 V limit is therefore never reached in principle 0 48 0049 5 15 Avril 2004 Technical description of boards On Off key S1 Starting up and shutting down Pressing key S1 polarises the gate of transistor U15 through D11 R201 and R170 so as to make it conduct U15 may be considered to be a main switch Line UBAT_SWITCHED switches to the cell voltage U_BAT_FUSED_CPU U15 is then kept closed temporarily by Q2 through C84 and D12 As soon as the Coldfire microcontroller has started the device is kept operating by pulsed signal CMD_OFF through C86 D12 and Q2 Signal ON_OFF_KEY is used to see the status of key S1 If it is kept pressed in for a long time the software ceases to send a signal to CMD_OFF and the device goes off The device is shut down by pressing the ON_OFF key for more than 3 seconds Analyse
42. efibrillator control circuit generates the activation signal of the Charge transistor signal On_OFF_CONV The IGBT responsible for the safety discharge S6 module IGBT is activated continuously by signal DECH_INT The microcontroller validates the oscillator powering command by means of signal STOP_CHARGE When the different operations are performed the HV capacitor charge is triggered by a pulse signal START_CHARGE and the HV generator starts oscillating to self power the HV generator While the HV capacitor is being charged the microcontroller measures the energy stored in the HV capacitor by means of signal V_HV1 While the HV capacitor is being charged IGBT S1 is blocked and S6 conducts making it possible to reference the potential of the upper branch of bridge H to the ground in order to ensure that the ECG signal collected by the adhesive defibrillation electrodes is stable When the 0 48 0049 5 32 APRIL 2004 Technical description of boards stored energy is equal to the selected energy the microcontroller stops the HV generator signal STOP_CHARGE and the defibrillator circuit switches to the preliminary charge completed stage where the defibrillation shock is blocked During the preliminary charge completed phase the microcontroller measures the energy stored in the HV capacitor by means of signal V HV2 If during the previous charging phase the ECG signal analysed by the CPU board confirms VF VT the CPU board sends a new ch
43. er supply to the real clock when the device is off VREF 2V5 Voltage reference used by the ADC converter 36 To DEFI board flat S Schema No CPU FRED EASY PORT Power supplies PBs wenooos syns SCHILLER MEDICAL 5 A 5 Project PCB No Date 4 rue Louis Pasteur Size A3 Drawn by Art No Sheet 3 of 7 7169 WISSEMBOURG CEDEX 0 48 0049 5 26 APRIL 2004 Technical description of boards SERIAL BUS vers Latchs du module LCD PWR BUS Diagram 4 Serial communication ColdFire lt gt SPI Mini SD Card ColdFire lt gt Defibrillator board ColdFire lt gt External PC set up RS232 links TTL levels Connector Mini SD Card RXD DEFI gt DEFI board ms XE DER To battery connector j Config T l chargement DET_PRESENT_SDCARD SPI_CS3 QSPICLK SPI_DATA_OUT CABLE PLAT vers carte DEFI lt _ SPI_DATA_IN WRITE_PROTECT_1 gt DEFI board To PIC microcontroller an Sheet 7 12 Communication with DEFI CPU FRED EASY PORT Serial links schema Noc Date MEDICAL S 4 rue Louis Pasteur Da i ZAE Sud BP50 Size A4 Drawn by Art No Sheet 4 of 7 67162 WISSEMBOURG CEDEX SCHILLER _ A S 0 48 0049 5 27 APRIL 2004 Technical description of boards Diagram 5 LCD interfaceand hardware configuration In
44. f the amplification and filtration chain is applied to comparators U33A and U33B which set off the tripping of two monostable triggers U33A and U33B At the output of the monostable triggers D19A D27A and R146 form an OR gate through which the recognition of a pacing pulse DETECT PACE is sent to Coldfire In response Coldfire sends to line BLOCK_PACE a low logical status for a definite time to shape signal INH_PACE which is used to open the ECG amplification chain when a pacing pulse is detected Signal INH_PACE is also sent to the defibrillator board where it is also used to open the amplification chain Signal INH_PACE_DETECT is used to block pace detection during the self test of the amplification chain Processing of other signals Signals Z ELEC DEFI DELTA Z UBAT SWITCHED CHK BAT DEF and CHK_EXT_PWR are filtered by RC networks before they are applied to the input of the ADC converter 0 48 0049 5 20 Avril 2004 Technical description of boards Electromagnetic compatibility EMC The CPU circuitry is enclosed in a metal housing that is connected at several points to the CAVE chip plan that acts as the reference for EMC filtration The CAVE chip plan occupies an outer layer of the CPU PCB and therefore makes up a closed enclosure with the metal housing All the CPU input and output signals are filtered by the RC and LC networks Description of port modules and labels Port module and label A 0 20 A10 PRECHG
45. filtering AD converter detection PACE amplification ECG STIM 3 1 gt ECG STIM INH PACE 4 gt ECG DEF INH PACE DETECT PACE INH PACE DETECT gt BLOCK PACE L gt VREF 2V5 Sheet 8 12 To DEFI vor via flat cable Sheet 5 12 Z ELEC DEFI VREF 2V5 Motion detector Z ELEC DEFI D Z ELEC DEFI DELTA Z C Sheet 9 12 EXT PWR CHK EXT PWR CHK BAT DEF gt CHK BAT DEF Hardware Battery E H ms version set up control CPU VREF_2V5 CHK BAT CPU C CHK BAT CPU UBAT SWITCHED CHK HW VERSION C Sheet 9 1 HK_BAT_CPU_F II CHK_BAT_CPU_F Sheet 9 12 gt CHK HW VERSION i INH PACE 3 To DEFI via flat cable BUF_DATA_BUS 1 0_BUS CPU FRED EASY PORT Analogical ADC Schema No SCHILLER MEDICAL S A Project PCB No Date 4 rue Louis Pasteur Size A3 Drawnby Art No Sheet 7 of 7 Fe WISSEMBOURG CEDEX 0 48 0049 5 30 APRIL 2004 Technical description of boards 5 3 5 3 1 Defibrillator board part no 3 2628 The lower part of FRED Easyport contains the housing for the Lithium MnO cell and the defibrillator PCB The defibrillator PCB part no WSM0040_ PCB includes the following parts e ECG preamplifier The ECG preamplifier acquires the ECG signal collected
46. g the HV capacitor charge the HV capacitor charge voltage is measured by a voltage divider that supplies signal V_HV1 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 by the CPU board the HV generator is disabled which stops the charge signal STOP_CHARGE When the defibrillator is in the hold phase the charge voltage is measured by a second voltage divider at the terminals of the HV capacitor signal V_HV2 During the charge and hold phases the high voltage circuit continues to insulate the patient by blocking S1 and making S6 conduct IGBT S1 is blocked by an optocoupler U21 and a photovoltaic cell OPT1 controlled by signals IGBT_OFF and GENERAL_EN generated by the microcontroller When the Shock key is pressed the defibrillator control circuit generates signal SHOCK_EN2 which in association with SHOCK_EN1 validates the defibrillation shock When the defibrillation shock is initiated the microcontroller generates two signals PHASE1 EN and PHASE2 EN that validate phases 1 and 2 respectively of the defibrillation shock The two signals continuously activate the two upper IGBTs S2 and S3 of the bridge H throughout the duration of each respective phase by means of two photovoltaic cells OPT2 and OPT3 The pulsed biphasic waveform is chopped or generated by the pulse trains of signals PHASE1_DECOUP and PHASE2_DEC
47. ignal from the defibrillator board It carries information about patient impedance Before it is applied to the converter signal Z ELEC DEFI is attenuated by two and filtered by dividing bridge R74 R76 and C48 Analogue signal generated from Z_ELEC_DEFI by the filter built around U31A It carries information about impedance variation used for detecting motion Signal used to measure the instant battery voltage CH4 CHK BAT CPU F Same signal as CHK_BAT_CPU only filtered to eliminate the instant variations due CH5 CHK BAT DEF CH6 CHK EXT PWR Note CH7 hardware version 0 48 0049 to brief current inrushes Signal for controlling the voltage applied to the high voltage HV converter on the defibrillator board when HV capacitor charging is under way Signal used to determine if the software must start up in AED mode or in set up mode If pin CHK EXT PWR pin 15 of P2 or pin 2 of battery connector JP5 on the defibrillator board is connected to U_BAT the device starts up in set up mode If CHK_EXT_PWR is not connected which means that a standard battery unit is being used the device starts in the AED mode Link U_BAT to CHK_EXT_PWR is made up of a special battery unit designed for downloading The voltage from a divider bridge is applied to input CH7 The value of resistor R81 determines the hardware version of the CPU board 5 19 Avril 2004 Technical description of boards ECG analoque
48. key S2 Starting an ECG analysis An analysis is started by pressing key S2 when the device is on The signal is directly sent to the PIC microcontroller of the defibrillator board Coldfire is informed of any press of the key via the serial link from PIC to Coldfire Note The Analyse key may also be read directly by Coldfire via latch U21 see LCD interface Shock key S3 Delivering a defibrillation shock The command for giving a defibrillation shock is given by pressing key S3 Pressing key S3 forces signal CHOC_KEY to zero The signal is transmitted directly to the PIC microcontroller of the defibrillator board Coldfire is informed of a press on the key via the serial link from PIC to Coldfire Note The Shock key can also be read directly by Coldfire via latch U21 see LCD interface Pressing the Shock key S3 is only applied when it is lit up by two orange LEDs D15 and D26 The LEDs are switched on by means of transistor Q3 and signal CMD LED CHOC generated by Coldfire Recognition of type of electrode The type of electrode used Child or Adult is recognised by means of a reed contact REL1 The Child type electrode connector has a permanent magnet that closes contact REL1 and forces signal TYPE_ELECTR to the low logical status The signal is sent to the microcontroller of the defibrillator Note The connector of the Adult electrode does not have a permanent magnet Light emitting diodes LEDs The device has 7 LEDs e
49. l BD_CS Buffered Data Chip Select generated by programmable circuit U10 controls the activation of U7 Address bus amplification The Coldfire address bus undergoes unidirectional amplification by means of U3 Only the eight low addresses A 0 7 are amplified With the exception of DRAM U4 and US all the other addressed peripherals use amplified address bus BA 0 7 Main clock A 40 96 MHz quartz oscillator U9 acts as the main clock CPU_CLK of Coldfire Generation of intermediate clocks and associated logical functions A programmable logic circuit U10 of the GAL22LV10 type is used to generate the secondary clocks and other synchronisation signals from main clock CPU_CLK and asynchronous counter U8 Secondary clock CLK4M096 is used by the ADPCM audio decoder Real time clock Real time clock U16 is controlled by Coldfire through data bus B D 16 31 address bus BA 0 7 and control signals CS3 OE and WE It performs the function of real time clock calendar and is controlled by 32 768 kHz quartz Q8 This clock is powered by the backup cell BT1 when the device is switched off When the device is running U16 is powered by VCC 3 3 V Note software set up data The software set up data of FRED Easyport are saved in the dedicated areas of the Flash memory U6 0 48 0049 5 14 Avril 2004 Technical description of boards Power supplies On Off pushbuttons and LEDs Figure Diagram 3 represents the following
50. l 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 and 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 0 48 0019 Page Il APRIL 2004 FRED EASYPORT 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 IEC 60601 2 4 Electromagnetic compatibility of medical electrical devices s 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
51. lved in device operation OE Signal generated by Coldfire to indicate that data are being read from the data bus OKI_FIFO_MID Status signal of ADPCM decoder FIFO ON_OFF_KEY Signal resulting from On Off key activation PF_RESET Reset signal generated by the voltage supervisor POWER_DOWN_AUX PROG ON Active when low Audio amplifier standby signal Used to force the starting up of the CPU board via connector P2 Not used during normal device operation PST O 3 Signals of port BDM and JTAG Not involved in device operation QSPICLK SPI serial link clock signal RASO SDRAM control signal RST DEFI Reset signal generated by Coldfire Applied to the defibrillator microcontroller REMOTE For future extensions Infrared link RSTO Reset signal controlled by Coldfire RTC WATCH DOG RXD DEFI Active when low Square signal generated by the real time clock and sent to Coldfire RS232 serial communication between Coldfire and the defibrillator Signal generated by Coldfire RXD PC Serial link with an external PC Set up and downloading Signal available on the battery connector JP5 on defibrillator board SDBAO SDRAM address bank control signal SDCLK SDRAM bus clock SDCLKE SDRAM bus clock control signal WRITE PROT 1 Signal indicating that the min SD card is write protected Active when low SDWE SDRAM control signal SPI_CS3 Address CS3 selection signal of SPI serial link SPI_DATA_IN Serial data of the SPI link
52. lyse key Recognition of electrode type child adult Delivery of defibrillation shock Shock key RS232 serial links through connector P2 26 pins Communication between Coldfire and defibrillator PIC Mini SD Card memory card interface LCD display interface CPU hardware configuration ADPCM decoder for voice prompts Audio amplifier for voice prompts Analogue to digital converter ECG signal analogue processing 0 48 0049 5 13 Avril 2004 Technical description of boards Description of subassemblies Microcontroller Figure Diagram 2 shows the MCU microcontroller unit The MCU is built around a host microcontroller U1 called Coldfire the working RAM U4 and U5 and the Flash memory U6 Coldfire is controlled by a 40 96 MHz quartz clock Note Configuration of Coldfire upon starting up Coldfire starts up as soon as signal PF_RESET hardware reset from the voltage supervisor appears and generates signal RSTO reset generated by Coldfire and used by devices While activating RSTO Coldfire reads entries BUSWO BUSW1 and WSEL which are used to set the communication speeds with devices Signals WSEL BUSWO and BUSW1 are generated by means of U2 Data bus amplification The Coldfire data bus undergoes bidirectional amplification by U7 With the exception of DRAM U4 and U5 all the other devices use amplified data bus B_D 16 31 Signal WE generated by Coldfire controls the direction of data transmission Signa
53. matic inspection before each use e Device housing check e No mechanical damage e No liquid penetration into the device e Control button and connector check 2 5 Cleaning and disinfection Important Switch off the device before cleaning Remove the cell before starting to clean the device in order to ensure that the device does not start up accidentally Before cleaning also disconnect the defibrillation electrode cables from the device No liquid must enter into the device If that does happen the device may not be used before it is checked by the after sales service department Users are strongly advised against cleaning the devices or electrodes with agents such as ether acetone esters or aromatic chemicals Never use phenol based cleaners or cleaners containing peroxide derivatives to disinfect the surfaces of the device housing e Systematically dispose of the single use electrodes immediately after use in order to ensure that they are not reused by mistake hospital waste e Before cleaning the electrode cables disconnect them from the device Clean and disinfect them by wiping them with a piece of gauze moistened with cleaner or disinfectant Never immerse the connectors in any liquid Use any cleaning or disinfectant 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 enter the device during cleaning 0 48 0049 Page
54. nd U25 CS5 ADC converter addressing U36 CS6 Not used for future use CS7 SDRAM memory addressing U4 and U5 D 0 31 Coldfire data bus DDATA 0 3 Signals of port BDM and JTAG Not involved in device operation DELTA_Z Analogue signal of the patient impedance measurement used for DETECT_PACE DET_PRESENT_SDCARD 0 48 0049 motion detection Pacing pulse detection signal Active when low Mini SD card presence detection signal Active when low 5 21 Avril 2004 Technical description of boards Port module and label DSCLK Description Signal of port BDM and JTAG Not involved in device operation DSI Signal of port BDM and JTAG Not involved in device operation DSO Signal of port BDM and JTAG Not involved in device operation DTEA Signal of port BDM and JTAG Not involved in device operation ECG_ADC ECG analogue signal applied to the ADC input ECG_DEFI ECG analogue signal delivered by the defibrillator preamplifier ECG_STIM Filtered ECG signal for extracting pacing pulses FLASH_BUSY Flash memory status signal Active when low FST_INHIB SYNC FST signal inhibition INH_PACE Control signal for opening the analogue switch of the amplification INH_PACE_DETECT chain while detecting a pacing pulse Pacing pulse detection inhibition signal Active when low INT4 End of conversion signal indicating that the converted data are available MTMOD Configuration signal of port BDM and JTAG Not invo
55. our FRED Easyport 2 1 Functional testing Functional testing is performed by the automatic test function In order to ensure that the device is operating correctly tests are conducted when it is switched on in the nominal mode SAD mode 2 2 Test mode Self tests are conducted automatically when the device is powered by the cell and is switched on by pressing the D On Off key The operator does not see the tests No message describing the tests is displayed when the device is running them A starting up screen is displayed during the self test procedure with the following information SCHILLER EASYPORT Sw CPU V01 00B1 Sw Defi V01 00B1 Hw CPU 3 Hw Defi 5 Language 16 19 01 04 15 54 1 TESTING Language Code 1 English 10 Finnish 19 Turkish 28 Walloon 2 French 11 Russian 20 Japanese 29 Latvian 3 German 12 Chinese 21 Hebrew 30 Tahitian 4 Spanish 13 Korean 22 Bulgarian 31 Brazilian 5 Italian 14 Romanian 23 Arabic 32 Slovak 6 Dutch 15 USA 24 Czechoslovakian 33 Polish 7 Swedish 16 Austrian 25 Quebec French 8 Portuguese 17 Danish 26 Hungarian 9 Norwegian 18 Greek 27 Flemish 0 48 0049 Page 2 1 Avril 2004 Testing and maintenance The tests cover the following functions 1 DS DO DE dcos To Hardware number test Acquisition system test ECG amp patient impedance Defibrill
56. p the ERC protocol The limit at which the memory is almost full is 98 e Memory full or no card indicator No memory symbol is displayed e Indicator of a problem with the procedure recording memory x This symbol flashes when the recording memory is not accessible write protected hot insertion electronic problem etc That does not stop the ERC protocol 0 48 0049 Page 1 8 Avril 2004 Operation 1 7 Technical specifications e Form of the defibrillation pulse Biphasic impulse of defibrillation pulsated with compensation of patient impedance e Standard energy settings Adult discharge in 50 Q 90 90 120 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 15 30 50 70 90 120 J Adult 15 30 50 70 Child Tolerance at 50 Q 3 J or 15 whichever is greater 100 80 60 20 current A 20 time ms e Automatic charge control after a shock is recommended following an analysis e Patient resistance 30 to 200 Q 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 goes on e The shock is delivered with key 4 e Internal safety discharg
57. pacitor FAULT DETECTION GENERAL DESCRIPTION In order to detect any critical fault conditions due to technical faults different circuits are monitored by the microcontroller When the FRED Easyport device is powered up the microcontroller runs a self test during which the specific operating of the uC is checked by mean of the following tests e watchdog operating test internal memory test ADC test Shock button test Besides when the defibrillator part is operating the microcontroller monitors the fault conditions below e test of the operating of the Charge transistor when the charge is triggered test of the operating of the HV generator during the charge test of the operating of IGBT S1 during the charge test of the operating of IGBTs S2 or S3 during the shock test of the operating of IGBTs S4 or S5 during the shock safety discharge time greater than 15s 0 48 0049 5 34 APRIL 2004 Technical description of boards Besides the defibrillator circuit also includes a hardware circuit designed to detect off range HV capacitor charging voltage The different fault conditions above are all detected by the microcontroller which then disables all the outputs runs a safety discharge and transmits an error message to the CPU board 0 48 0049 5 35 APRIL 2004 Technical description of boards 5 3 2 TIME CHARTS HV CAPACITOR CHARGE CHARGE REQUEST 120J ON_OFF_CONV ud 0 UBAT F DEFI switched by Q6 C Ww g
58. read by Coldfire SPI_DATA_OUT Serial data of the SPI link generated by Coldfire SYNC_FST Synchronisation signal TEST Configuration signal of port BDM and JTAG TYPE_ELECTR TXD_DEFI 0 48 0049 Not involved in device operation Recognition of Child Adult electrode type RS232 serial communication between Coldfire and the defibrillator Signal generated by the defibrillator microcontroller 5 22 Avril 2004 Technical description of boards Port module and label TXD_PC UBAT UBAT_FUSED_CPU UBAT_SWITCHED Description Serial link with external PC set up and downloading Signal available on the battery connector Device power supply voltage on connector P2 Power supply voltage after the protective fuse Switched power supply voltage VREF_2V5 2 5 V reference voltage WE Signal generated by Coldfire to indicate that data are being written to the data bus Z ELEC DEFI Signal representative of patient impedance 17 5 V 17 5 V auxiliary voltage Used to command the IGBTs on the defibrillator board and the LCD 3 3 V 3 3 V auxiliary power supply voltage Mainly used by the digital part of the CPU PCB 5 V Auxiliary 5 V power supply voltage Power supply of the analogue part of the CPU and defibrillator 5 VOP Filtered 5 V power supply voltage 0 48 0049 5 23 Avril 2004 Technical description of boards Patient Electrodes Inputs DEFIBRILLATOR CIRCUIT
59. rge preliminary charge completed and hold phases in order to insulate the patient The gates of the IGBTS of the high voltage unit that are not referenced to the ground S1 S2 and S3 are controlled by an optocoupler and photovoltaic cells The IGBTs are controlled by signals IGBT_OFF GENERAL_EN PHASE1_EN and PHASE2_EN During the defibrillation shock phase the microcontroller directly generates the signals required to control the pulsed biphasic waveform when the shock validation circuit is activated by signals SHOCK_EN1 and SCHOCK EN2 Before activating the IGBTs of bridge H the microcontroller blocks IGBT S6 and makes S1 conduct During the defibrillation shock the microcontroller controls the IGBTs to generate the patient impedance compensated pulsed biphasic waveform First of all after S1 closes IGBT S2 is activated continuously by signal PHASE1_EN After a small delay IGBT S5 is controlled by signal PHASE1 DECOUP as regards the pulses of phase1 During the first pulse the microcontroller determines the patient impedance and on the basis of the impedance applies a constant cyclical ratio to the chopping signal After a set time following the first phase IGBT S3 starts conducting continuously signal PHASE2_EN and then IGBT S4 is controlled by signal PHASE2_DECOUP which leads to the pulses of phase 2 After the defibrillation shock IGBT S1 is blocked when S6 is saturated and the energy remaining after the shock remains stored in the HV ca
60. s of shocks 1 2 and 3 with a distinction between adult and child values starting of the ECG analysis by pressing the keyboard or automatic Procedure chart Check for signs of circulation If no signs of circulation rescue 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 0 48 0049 Page 1 7 Avril 2004 Operation 1 6 Recording optional For information the memory card can save half an hour of ECG 500 events relating to the procedure see overview opposite In the nominal operating mode the device records different types of information throughout the procedure Recording starts when the device is powered up and runs in the nominal mode and stops when the device is switched off 24 e Saving in progress indicator This symbol is displayed steady display and the percentage is incremented as the memory card is filled up 99 e Memory almost full indicator This symbol flashes when the recording memory is almost full That does not sto
61. serial link at 9600 bauds Signal TXD_DEFI from the defibrillator microcontroller is directly applied at the input of Coldfire Signal RXD DEFI generated by Coldfire is sent to the microcontroller of the defibrillator by means of a voltage level adaptation stage which is made up of Q1 and Q5 Serial communication between SPI and the mini SD card interface The mini SD Card interface is made up of special connector JP1 designed to accommodate memory cards During the procedure the card is used to record the ECG signals and events of the procedure The mini SD card is controlled by Coldfire through signals SPI_CS3 QSPICLK SPI_DATA_IN and SPI_DATA_OUT Signals DET_PRESENT_SDCARD and WRITE_PROT_1 are status signals of the memory card which indicate mini SD card presence and write protection respectively The signals are active in the low logical state The lines linked with JP1 are all protected by 220 Q resistors The mini SD card power supply is protected by resistor R253 0 48 0049 5 17 Avril 2004 Technical description of boards LCD display Figure Digram 5 represents the LCD interface of FRED Easyport The LCD display is controlled by Coldfire by means of data bus B_D 24 31 and signals CS1 and CS4 Data is written in the LCD registries by means of latch U23 and is controlled by signal LCD_WR generated by latch U22 Data are read from the LCD registries by means of latch U24 and is controlled by signal LCD_RD generated by
62. t 4 4 0 START_CHARGE 100 ms signal U3 p1 0 CHARGING VDS Q9 switching transistor f 60 kHz UBATT 1 1 1 1 1 1 1 1 L 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 A 1 1 LI T 1 1 1 1 U 1 1 1 1 i 0 STOP_CHARGE a Wemm 125 J 1 1 1 HV capacitor i SHOCK charge voltage N K 1 11 0 standby l Charge phase i Hold phase 1 I standby max 20s i i IGBT S6 1 70T Vee i 0 ad ii 205ms t Press on Shock button gt In ms IGBT S1 i Vee tt 0 NE 165 ms 1 40ms t 0 48 0049 5 36 APRIL 2004 Technical description of boards DEFIBRILLATION SHOCK 150 ms 40 ms 50 us 1 ms 60 ms lt gt Kart gt lt Ze SHOCK ENI A gt DECH INT IGBT OFF gt GENERAL_EN Ac 500Hz 50 SHOCK EN2 A PHI EN PHASEI mm II I PH2_EN EE m TN 23ms 3 ms 50 us 1 5 ms 50 us 700 us ES 0 48 0049 5 37 APRIL 2004 Technical description of boards OAPEX Electrodes Connector STERNUM a FRED EASY PORT Defibrillator board JPI a ibid L INH PACE 219 ECG DER
63. terface latchs gt 3 3V i PWR BUS 175V LCD contrast BUF DATA BUS E B D 16 31 LCD RES CS 0 7 LCD RS LCD CS PF RESET PF RESET LCD WRI LCD RD CTRL BUS DTE gt OE LCD_CDBJ 0 7 CFG_LP6 CFG_LP7 5 jumpers CFG_LP8 SET BACKL for CFG LP9 hard CFG_LP10 argware Hardware configuration configuration l SD Card connector gt WRITE PROT 1 Sheet 10 l Driver K gt LCD CDB O 7 SET BACKL Backlight LEDs 12 Sheet 10 12 CPU FRED EASY PORT LCD Interface Size A4 Drawn by Art No Schema No SCHILLER MEDICAL S A S Date 4 rue Louis Pasteur Sheet 5 of 7 ZAE Sud BP50 0 48 0049 5 28 APRIL 2004 Technical description of boards Diagram 6 ADPCM decoding Audio amplification ADPCM decoder Audio amplifier To speaker JP5 To speaker BUF_DATA_BUS gt POWER DOWN AUX BUF ADRS BUS E 5V Sheet 11 12 5VOP Sheet 11 12 CPU FRED EASY PORT Audio amplification Schema No SCHILLER MEDICAL S A S 4 rue Louis Pasteur Date ZAE Sud BP50 Sheet 6 of 7 67162 WISSEMBOURG CEDEX 0 48 0049 5 29 APRIL 2004 Technical description of boards Diagram 7 Analogue ECG processing AD conversion ECG DEFI Pacing ECG
64. tor PCB the ECG preamplifier is located close to RV1 under the upper metal shielding The ECG preamplifier part amplifies the ECG signal and measures the patient impedance The patient s ECG signal is collected through the adhesive defibrillation electrodes The amplified ECG signal is transmitted in analogue form to the CPU board The ECG preamplifier board supplies two ECG signals signal ECG_DEFI designed for analysing and recognising fibrillation and signal ECG_STIM that is used to detect any pacing pulses The ECG signals are analysed and interpreted on the CPU board If pacing pulses are detected the CPU board directly controls the ECG acquisition circuit of the ECG preamplifier signal INH_PACE The ECG signal acquisition circuit test is controlled by the uC of the defibrillator circuit 30 kHz signal which injects a square signal with a 10 Hz frequency for 2 seconds into the 30 kHz signal when FRED Easyport is switched on That 10 Hz signal is used to check the operating of the ECG signal acquisition circuit by the CPU board The ECG preamplifier part also measures patient impedance through the 30 kHz square signal After treatment the 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 to permit the defibrillation shock only if the defibrillation electrodes are stuck correctly signal Z_ERROR DEFIBRI
65. tor circuit The defibrillator function of FRED Easyport is a sequential circuit with six distinct phases 1 Standby phase phase during which FRED Easyport is powered and the defibrillator part is standing by no request for a charge 2 Charge phase phase during which the HV generator charges the HV capacitor 45 uF 2 4KV The charge phase may be initiated by two distinct commands e Preliminary charge command e Charge command 3 Preliminary charge completed phase that follows the preliminary charge command when the selected energy value is reached During this phase the defibrillation shock is blocked 4 Hold phase phase that follows a Charge command when the selected energy is reached This phase lasts at least 20 seconds during which time the HV capacitor remains charged FRED Easyport is ready to give a defibrillation shock 5 Shock phase this is the phase during which FRED Easyport gives the patient impedance compensated pulsed biphasic defibrillation shock 6 Safety discharge this is the phase during which the energy stored in the HV capacitor is discharged into a circuit internal to FRED Easyport 0 48 0049 5 31 APRIL 2004 Technical description of boards ECG PREAMPLIFIER The preamplifier part performs the following functions e ECG signal acquisition e ECG signal amplification and processing e Acquisition circuit verification e Patient impedance measurement GENERAL DESCRIPTION On the defibrilla
66. yout drawings 7 1 CPU circuit 3 2627 7 2 Defibrillator circuit 3 2628 0 48 0019 Page VI APRIL 2004 1 1 1 1 1 2 1 3 1 4 1 6 1 8 1 9 2 1 2 1 2 2 4 2 4 3 1 4 4 4 5 4 6 4 8 4 9 4 10 4 10 5 12 5 12 5 13 5 31 6 1 6 1 6 1 7 1 7 1 Operation 1 Operation This section briefly outlines the operating of the device For more detailed information please refer to the User s Manual 1 1 Display and controls Green D key to switch the device on and off to stop supporting more than 3 seconds The yellow indicator lamp flashes as long as the electrodes are not in place Connection of adhesive electrodes Display Blue key to start analysing Key for triggering the defibrillation shock O O1 BR N 0 48 0049 Page 1 1 Avril 2004 Operation 1 2 Battery and minicard 7 Battery 12V 8 SD Minicard protection 9 SD Minicard 0 48 0049 Page 1 2 Avril 2004 Operation 1 3 Explanation of symbols used Symbols on the device or accessories JAH 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 S Number of shocks given since starting up D Battery

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