Start100 eng
Contents
1. Printing system Printing channels Paper driving speed Thermo sensitive paper Filters Keyboard Led Interpreting Program START 100 H Parameters calculation START 100 P Operating mode Usage mode Autonomy Recharging time Caovering protection degree AFTER SALES SERVICE Class first 110 120 V 10 50 60 Hz 220 240 V 10 50 60 Hz 0 28 A at 110 120V 10 014 Aat 220 240V 10 T 0 315 A 250 V 5x20 mm fuse at 110 120 V T0 16A 250 V 5 x 20 mm fuse at 220 240 V Built in lead rechargeable battery 12V 0 8 Ah T 2 A 250V 5x20mm fuse CF type Inside the apparatus 300 mV 0 Hz 6 4 mV in the passing through band gt 100 MQ on each electrode 95 dB 0 05 150 Hz 3dB without filters gt 3 3 sec 12 bits 1000 samples sec printing channel and filters 500 samples sec channel during calculation phase 3 125 uV bit resolution 12 STANDARD leads out of which 8 acquired 4 reconstructed III aVR aVL aVF 10 s for each lead in self isochronous mode 5 10 20mm mV 5 3 channels printing 10 mm mV for 0 3 3 mV signals 5 mm mV for signals gt 3 mV 20 mm mV for signals lt 0 3 mV 6 channels printing 10 mm mV for 0 15 1 5 mV signals 5 mm mV for signals gt 1 5 mV 20 mm mV for signals lt 0 15 mV Thermal printing unit 8 dot mm Printing useful height 108 mm 3 6 5mm s 10 25 50 mm s 5 DOT CARD 130 mm in 25 metres rolls Mains disturbancies2. THIS TEST TO BE MADE AFTER EACH OPENING FOR INSPECTION AND OR REPAIR USING TOOL 4 1 B AND IN ANY CASE EVERY TWO YEAR PERIOD Proceed as follows 4 3 1 Connect the electrocardiograph to the measuring instrument according to the instructions given in its user s manual and remember that a The leakage current towards ground is measured between the mains power supply circuits and the ground point of the equipotential outlet Table T2 b The leakage current towards the case is measured between the mains power supply circuits Table T2 the equipotential outlet Table T2 and a metallic sheet not greater than 20 x 10 cm in size which should be pressed against the case if composed of insulating material c The leakage current in the patient is measured between the mains Table T2 and the applied part Table T2 The same patient cable can be used for the connection with the applied part d The leakage current in the patient with mains voltage directly on the applied part first fault condition is measured between the equipotential connection Table T2 and the applied part Table T2 e The auxiliary current in the patient is measured individually on each electrode with the exclusion of the black one with respect to all the other electrodes connected together 4 3 2 Program the instrument according to the electrocardiograph type CF and class first 4 3 3 Perform the measurement according to the instructions given in the u
3. 240V code 60500060 Code Description 69700528 69701065 69700077 69700197 69701070 69701071 69701072 69701083 69701097 69701074 69701027 69701075 69701076 69700162 69701098 69701078 69701079 69701080 69701099 69700932 69701082 AFTER SALES SERVICE 12V 0 8 Ah battery Kymograph T 0 16 A fuse 10 pieces T 2 A fuse 10 pieces 4 A fuse SLO BLO SMD 10 pieces Paper feed complete ON OFF switch Internal cables kit Interpreting EPROM kit Insulating membrane kit SMD led 8 green pcs 2 yellow pcs 10 pieces Lower case complete Upper case complete Paper spindle 3 C CPU acquisition board START 100 H 220 V hardware Sensors board Keyboard Printer complete Keyboard membrane Key for the keyboard 10 pieces 14 VA 230 22 V transformer Table 10 3 42 List of spare parts for SPA MEDICAL DEVICES START 100H 110 120V code 60500062 Code Description 69700528 69701065 69700197 69701070 69700331 69701071 69701072 69701083 69701097 69701074 69701027 69701075 69701076 69700162 69701104 69701078 69701079 69701080 69701099 69700932 69701082 AFTER SALES SERVICE 12V 0 8 Ah battery Kymograph T 2 A fuse 10 pieces 4 A fuse SLO BLO SMD 10 pieces T 0 315 A fuse 10 pieces Paper feed complete ON OFF switch Internal cables kit Interpreting EPROM kit Insulating membrane kit SMD led 8 green pcs 2 yellow pcs 10 pieces Lower case complete Upper case comp
4. MEDICAL DEVICES page page page page page page O O O1 L J page SPA MEDICAL DEVICES 7 Disassembling and reassembling the apparatus page 31 7 1 Foreword page 31 7 2 Opening and closing the apparatus page 31 7 3 Disassembling the mother board page 31 7 4 Disassembling the battery page 32 7 5 Disassembling the keyboard page 33 7 6 Disassembling the paper driving motor group page 33 7 7 Disassembling the printer group page 33 7 8 Disassembling the paper and notch sensors card page 33 7 9 Disassembling the paper lid page 34 7 10 Disassembling and replacing the keyboard plate page 34 7 11 Mains fuses page 34 8 Calibrations page 35 8 1 General information page 35 8 2 Calibrating the sensitivity of paper and notch presence sensors page 36 8 3 Calibrating the paper speed page 36 9 General directions for maintenance page 37 9 1 Foreword page 37 9 2 Messages page 37 9 3 Inspection schedule page 38 9 4 Cleaning the thermal head page 39 10 List of spare parts page 40 10 1 General information page 40 APPENDIX A Procedures for handling and storing electronic components sensitive to electrostatic discharges ESD page 45 llustrated tables page 47 AFTER SALES SERVICE 3 SPA MEDICAL DEVICES FOREWORD AND SPECIAL REMARKS This apparatus is a multilingual class first and CF type portable electrocardiograph with 3 6 printing channels and dual power supply mains battery The apparatus uses 130 mm wide rol
5. s through IC33 regulator in order to keep the data when the apparatus is off e Following supply voltages are obtained from TR1 multivoltage transformer 5 V through IC90 regulator to supply the digital logic 25 V Vset to supply the thermal head illustrated in chapter 6 5 5 Volt respectively stabilized by IC38 IC39 to supply the analogic circuits on the insulated part Should all of the power supplies be missing check and or replace the 4A F1 pico fuse type SLO BLO SMD foreseen in the spare parts list Should the values measured during the checks be wrong it is advisable to replace the mother board AFTER SALES SERVICE 30 SPA MEDICAL DEVICES 7 DISASSEMBLING AND REASSEMBLING THE APPARATUS 7 1 FOREWORD Before opening the unit all necessary precautions shall be taken to avoid possible errors or incorrect operating procedures In particular a always follow the directions given in appendix A of this manual regarding the operating procedures the tools needed and the precautions to be taken when working on E S D components b before reassembling the unit the required calibrations as described in chapter 8 of this manual shall be performed c before closing the apparatus it is necessary to check that all subassemblies and connections are properly installed d before closing the apparatus check the proper assembly and positioning of the insulating plates located as follows on patient input conn
6. 5 V d c power supply voltage Check keyboard BROKEN Replace keyboard e When a failure occurs It is a good practice checking the efficiency of all the connections flat wires terminals if they are damaged replace them with an equivalent type provided in the spare kit e Check the presence of 5 V voltage e Check the operation of keys and leds with a tester e If the mentioned circuits are repairable and operating and the apparatus still does not accept any command it is advisable to replace the mother board Replace mother board AFTER SALES SERVICE 23 UE A MEDICAL DEVICES 6 5 MALFUNCTIONS DURING PRINTING PROCESS FLOW ANALYSIS AND TECHNICAL DESCRIPTION refer to electrical diagram file name POW SUP and XILINX ABNORMAL PRINTOUT NO PRINTOUT Too heavy Irregular or weak Check connection flat Check 24 V d c power Clean thermal head supply voltage chapter 9 4 Check 24 V d c power supply voltage NOT CORRECT CORRECT Defective mother board Check connections Check recording signals CORRECT Replace mother board Check 24 V d c power CORRECT NOT CORRECT supply voltage and recordings signals CORRECT Replace printer Defective mother board Check 12 V d c power Replace mother board supply voltage CORRECT Check mechanical assembly Check paper AFTER SALES SERVICE 24 SPA MEDICAL DEVICES 6 5 1 There is no print out e Check th
7. Ah dimensions 96 x 62 x 25 mm width depth height weight 350 g recommended make FIAMM GS FG20086 SAFETY NOTE The battery can only be replaced with the recommended type or an equivalent one as to both the electic characteristics and the mechanical ones 2 3 MOTHER BOARD The mother board is a multilayer printed circuit card six layers in fine line technology for the assembly of SMD components Surface Mounting Devices It houses most of the apparatus electronic circuits and may be divided in the following sections with reference to the electrical block diagram file name Blok 100 AFTER SALES SERVICE 9 SPA MEDICAL DEVICES 2 3 1 POWER SUPPLY FROM MAINS The power supply from mains is a Class type therefore it assures the apparatus electrical safety only if the protection earthing yellow green wire of the power supply cable is connected to a system realized in compliance with the laws in force The section consists of the following parts separable three wire mains cable three pin mains plug with built in extractable fuses table T 2 protection devices VDR and PTC and disturbances filtering devices mains transformer complying with medical standards code ET 69701082 table T 6 rectifying filtering and voltage adjustment circuits with current limiter for the recharge of the built in battery Such circuits do not allow operating the apparatus without the battery con
8. The self test function can be activated by depressing the COPY key within 3 seconds from the apparatus start up The apparatus prints out a triangular wave to check the efficiency or detect failed dots of the printer head if any the alphanumeric types available in the memory and some step signals to check the 3 velocities Then it prints out a page reporting the result of the RAM test the total number of pages printed so far the code and the software revision and a warning to remind proceeding with the keys test Depressing the keys in sequence lights the related led up as follows MAN 50 mm sec AUTO 25 mm sec C COPY 10 mm mV VELOCITY 5 mm mV AMPLIFICATION 50 Hz filter FILTERS ADF filter STOP saturation This configuration can be abandoned by depressing the STOP key that lights up the orange led and brings the apparatus back to the normal ready for use status AFTER SALES SERVICE 19 SPA MEDICAL DEVICES 6 DETECTION OF THE DAMAGED CIRCUITS AND ANALYSIS OF THE MAIN MALFUNCTIONS 6 1 INTRODUCTION After the introduction of SMT technology Surface Mounting Technology and of fine line multilayer printed circuits singling out and repairing the damage have become extremely difficult even with adequate equipment and tools Therefore it is advisable not to attempt the repair of single cards whereas their replacement is suggested Quite often an inadequate intervention prevents any possibility of further rep
9. after a long interruption of the internal d c power supply to the memories such to cause loosing the stored data even if partially 4 Incase of loss of data stored in the memory even if partial occurred after switching the apparatus off NOTE The two sensors S1 notch passage and S2 paper presence can be seen extracting the paper lid of the paper housing table T1 dust or whatsoever material on the protecting glass alter the sensors sensitivity A good procedure recommends to check and if necessary clean the glass surface using alcohol soaked cotton before calibrating the sensors A strong light directed to the apparatus may influence the sensor AFTER SALES SERVICE 35 SPA MEDICAL DEVICES 8 2 CALIBRATING THE SENSITIVITY OF THE PAPER AND NOTCH PRESENCE SENSORS refer to electrical diagram file name M SPEED Required instrumentation d c voltmeter Proceed as follows a disconnect the apparatus from the mains b open the apparatus as described at chapter 7 3 a b c e keeping all connections active Pay attention to keep the card isolated from the conductive inside of the case c connect the battery supply Calibration of the paper presence sensor a connect the negative pole of the voltmeter to the DGND earth b connect the positive pole of the voltmeter to either pin 3 of the integrated circuit IC36 or the dedicated J39 contact c remove the paper if inserted and install the paper lid d sw
10. all the other terminals of the cable to the negative pole of the instrument 5 1a carry out a recording for a few seconds check that the width of the recorded signal is equal to 20mm 5 over all the channels Reference IEC 62 D CO 6 Regulations repeat the test with leads V4 V6 5 3 ECG LEAD TEST Proceed as follows a b c d turn on the apparatus connect the patient cable to the apparatus connect the patient cable red terminal to the positive pole of the instrument 5 1 a and the remaining ones to the negative pole Start recording and check that the signal width in mm and its polarity positive or negative agrees with the values given in Table 5 3 repeat the measurement in succession with all the remaining active terminals G V C1 C2 C3 C4 C5 C6 of the patient cable in the same manner as in c and check that the values correspond to those reported in Table 5 3 AFTER SALES SERVICE 16 SPA MEDICAL DEVICES LEADS AND PATIENT CABLE TEST CONNECTIONS FOR TESTING N 1 Terminal on positive black excepted 1 N 4 Terminals on negative with 5 wires cable N 9 Terminals on negative with 10 wires cable Square wave signal Electrocardiograph 1mV 10 mm amlificaiton 1Hz 1 1 mVpp 3 recorded signal inmm 5 TABLE OF VALUES i LEADS AND PULSE VALUES ge fme M VR avl AVF yi y2 ys y ys ye positive mm mm mm mm imm fmm mm mn m m mm mm j mm R _ 10 10 0__ 10 5_ 5 3 3 3 3 3 3 3
11. and the auxiliary power supply if provided AFTER SALES SERVICE 10 SPA MEDICAL DEVICES SAFETY NOTE The connection to the intermediate circuits for instance through the serial interface RS232 may be realized only and exclusively towards other medical apparatus according to IEC 601 1 1 standard relating to the medical systems safety Should any doubt exist about the compliance to the medical standards of the apparatus connected to the intermediate circuits e g a Personal Computer make use of a galvanic de coupling device that may be provided by request 2 3 4 INSULATED PREAMPLIFIER This section consists of a 12 channels ECG preamplifier with active control of the reference electrode complete with protection from the effects of defibrillation and 12 bit analog digital conversion circuit The galvanic de coupling is performed by means of a guard zone on the printed circuit 4 mm minimum insulation and photo couplers 2500V rms minimum for 1 minute insulation SAFETY NOTE We strongly advise against any intervention on the components assuring the patient insulation such as the photo couplers and the insulation transformer of the DC DC converter generating the intermediate and insulated power supplies In case of failure replace the mother board 2 4 KEYBOARD This card houses only the keys and leds required for the operation of the apparatus 2 5 PAPER SENSORS BOARD This card houses the sensors signalling the paper pres
12. board d entire mother board 4 2 1 INSULATING TEST TOWARDS MAINS POWER SUPPLY Perform this test with the mains switch inserted Table T2 a Apply the test voltage between the pins with the exclusion of the central pin in the apparatus mains plug Table T2 and the equipotential outlet which is connected to the frame ground of the apparatus Table T2 b How the performance test is carried out class electrocardiograph first Apply for 10 seconds a voltage equal to 0 750 KVac then raise it to 1 5 KVac and hold it at this value for 1 minute AFTER SALES SERVICE 13 SPA MEDICAL DEVICES 4 2 2 DECOUPLING TRANSFORMER AND OPTOINSULATOR TEST CF type electrocardiograph defined by this symbol e Perform this test with the apparatus turned off a Apply the test voltage between all the Pins of the patient input outlet connector Table T2 and the equipotential outlet Table T2 b Apply for 10 seconds a voltage equal to 1 25KVac then raise it to 2 5KVac and hold it at this value for 1 minute 4 2 3 IN BOTH TESTS 4 2 1 4 2 2 Verify that during the test there are neither superficial nor destructive discharges Moderate discharges due to the back effect can be ignored as long as they stop when the test voltage is temporarily lowered to a lower value which nevertheless must remain greater than the reference voltage U 250V as long as the discharges do not result in test voltage drops 4 3 LEAKAGE CURRENT TEST
13. outputs is the maximum value causing no damage to the apparatus AFTER SALES SERVICE 2 SPA MEDICAL DEVICES APPARATUS DESCRIPTION The apparatus consists of the following main components case internally painted with conductive and shielding paint complete with paper lid plate keyboard and serigraphs sealed lead battery main electronic card hereinafter called mother board keyboard card paper sensors card printer mechanical group complete with thermal head mechanical group of the paper driving device 2 1 CASE The case consists of two parts the upper housing made of polycarbonate Lexan 940 colour RAL 7035 the lower housing made of ABS colour RAL 7025 Both parts are internally painted with conductive and shielding paint Such lining is highly conductive and works as a shielding both against the radio disturbances generated by the apparatus and those externally produced which could cause malfunctions The fastening columns of cards and mechanical components as well as the PVC insulating plates are an integral part of the case SAFETY NOTE The mentioned insulations are strictly required to guarantee the safety features of the apparatus If they are removed during an inspection or repair of the apparatus they must be exactly restored as foreseen by the design 2 2 BATTERY The battery is a lead sealed type accumulator having the following characteristics voltage 12 V capacity 0 8
14. to describe the maintenance interventions necessary for a correct and long lasting operation of the apparatus f to supply a list of spare parts AFTER SALES SERVICE 5 SPA MEDICAL DEVICES REFERENCE STANDARDS The safety characteristics of the electromedical class apparatus are in accordance with the regulations EN 60601 1 1990 General regulations for the safety of electromedical equipments EN 60601 1 1990 A1 1993 EN 60601 1 1990 A2 1995 EN 60601 1 2 1993 Regulations about the electromagnetic compatibility of electromedical equipments IEC 601 2 25 1993 Special safety regulations for electrocardiographs IEC 62D CO 6 1978 Special regulations about the performance of the electrocardiographs SPECIAL REMARKS a Please remember that by following the instructions outlined in this manual the apparatus and its accessories will be correctly and efficiently maintained and consequently will be safer and will last longer b Please remember that this service manual is only addressed to technically competent persons c Please remember that all the instrumentation described or indicated in this service manual is necessary to correctly carry out tests calibrations and controls of the safety characteristics of the apparatus d Please remember that whenever the apparatus is opened for inspection or assistance a complete control of the safety characteristics as described in chapter 5 must be carried out before the
15. 3 3 3 3 3 G 10 0_ 10 5 10 5 3 3 3 3 3 3 3 3 3 3 3 3 V__ 0_ 10 101 8 L5 10 33 33 33 33 33 3 8 0 o wo jo ce o jo jo jo jo jo jo jo jo jo oO 10 Table 5 3 5 4 CHECK OF THE PAPER DRIVING SYSTEM Proceed in the following manner a turn on the apparatus and connect the patient cable b connect the C1 C6 terminals of the patient cable to the positive pole of the instrument 5 1 a c all the other terminals should be connected to the negative pole of the instrument 5 1 a d using the instrument with a 1Hz square wave of 1 mVpp width e record the signal on the leads V1 V6 f measure the length of the wave period recorded on the paper It should come out to be Period 25 mm 5 for 25 mm s speed Period 50 mm 5 for 50 mm s speed Period 5 mm 10 for 5 mm s speed AFTER SALES SERVICE 17 SPA MEDICAL DEVICES NOTE It s not necessary to calibrate the paper feed rate because this control is automatically managed by the microprocessor 5 5 CHECK OF THE FREQUENCY RESPONSE Proceed as follows a turn on the apparatus and connect the patient cable b connect the C1 C6 terminals of the patient cable to the positive pole of the instrument 5 1 b c all the other connectors should be connected to the negative pole of the instrument 5 1 b d prearrange the generator on a 10Hz sinusoidal wave with about 1 mVpp width e select V1 V6 leads and 10 mm mV sen
16. SPA MEDICAL DEVICES CARDIETTE SERVICE MANUAL START 100 H amp C Medical Devices S p A a Via Pisa 250 MEDICAL pEvices 20099 SESTO S G MI ITALY Rev 01 Data 28 May 1999 Code Nr 66500092 AFTER SALES SERVICE 1 INDEX Foreword and special remarks Installation program Register number Aim of the manual Reference standards Special remarks Technical characteristics Apparatus description Case Battery Mother board Keyboard Paper sensors board Printer mechanical group complete with thermal head Mechanical group of the paper driving system Protection from defibrillation Inputs and outputs Connection to the patient input socket Check of the safety characteristics Required instruments Applied voltage test Leakage current test Check of the main characteristics of the electrocardiograph Required instruments Sensitivity test Test of the ECG leads Check of the paper driving system Check of the response in frequency Check of the power supply and battery recharge Technical self test Detection of the damaged circuits and analysis of the main malfunctions Introduction Purpose The apparatus does not switch on The apparatus does not correctly accept the keyboard commands Malfunctions during printing process Malfunctions during paging and paper presence signalling Malfunctions caused by defective paper driving Illustration of the power supply voltage AFTER SALES SERVICE SPA
17. The velocity must be steady with slow voltage variations in the range 13 5 10 5 Vd c AFTER SALES SERVICE 36 SPA MEDICAL DEVICES 9 GENERAL DIRECTIONS FOR MAINTENANCE 9 1 FOREWORD START 100 P H electrocardiograph has been designed to grant a high reliability and maintainability of the product during the whole operating life However it is always necessary to scrupulously follow the directions of both this manual and the user manual during the whole operating life of the apparatus START 100 P H electrocardiograph is provided with a computer aided automatic system capable of controlling and managing all the functions of the apparatus Any wrong use or anomalous working condition is indicated by blinking green leds by the lighting of orange leds or by messages printed on paper The programming phase is guided by the relevant print out 9 2 MESSAGES Signalling of the operating status Orange led Battery discharged Orange led Inputs saturation Velocity green leds blinking Paper lacking and or open lid All leds alight but the Switching on phase discharged battery one Last phase of self test Green leds alight either one Programming phase by one or in pairs Messages on paper Self test print out Guide to programming The memory does not contain the electrocardiographic tracing since the last recording was manually carried out or the apparatus was not switched off correctly Sensitivity leds blinking Acquisi
18. ad to be carried out when the apparatus is switched off is required as indicated at table 9 3 The correct periodic cleaning of the thermal printing head grants a true and precise reproduction of the E C G tracing and a long life of the printing system 9 4 2 TOOLS NEEDED a THERMAL HEAD cleaning marker code 66020004 9 4 3 CLEANING PROCEDURE Proceed as follows a open the lid of the printing unit b pass the special tool on the dots of the thermal head paying attention to avoid touching the head with the hands or other tools NOTE The thermal printing head is highly sensitive to electrostatic potentials Therefore it is recommended not to touch it for any reason whatsoever In case of need handle it after earthing yourselves through a suitable protected strap or armlet AFTER SALES SERVICE 39 SPA MEDICAL DEVICES 10 LIST OF SPARE PARTS 10 1 GENERAL INFORMATION Tables 10 1 10 2 10 3 and 10 4 report the code number of the spare parts When ordering a spare part please refer to the table corresponding to the apparatus List of spare parts for START 100 P 220 240V code 60500052 Code Description 69700528 69701065 69700077 69700197 69701070 69701071 69701072 69701083 69701073 69701086 69701074 69701027 69701075 69701076 69700162 69701077 69701078 69701079 69701080 69701099 69700932 69701082 AFTER SALES SERVICE 12V 0 8 Ah battery Kymograph T 0 16 A fuse 10 pieces T 2 A fuse 10 p
19. air once the apparatus is sent back to the factory 6 2 PURPOSE This chapter provides the repairman with useful information in order to single out the failed card and or group For that purpose the analysis of the possible malfunctions or failures is synthesized in flow diagrams and subsequently developed in detail according to the circuit logic reported in the general block diagram of the apparatus and mother board AFTER SALES SERVICE 20 SPA MEDICAL DEVICES 6 3 THE APPARATUS DOES NOT SWITCH ON FLOW ANALYSIS AND TECHNICAL DESCRIPTION refer to electrical diagram file name ACCU 12 V QUIPMENT DOESN T SWITCH ON heck the T 2 A batter fuse Verify current comsumption max 1 8 Ad c Verify battery operation Verify fuse burnout cause Remove fuse burnout cause erify the 12 V power Replace battery supply circuit Replace fuse BROKEN Verify ON OFF circuit BROKEN Replace mother board AFTER SALES SERVICE 21 SPA MEDICAL DEVICES 6 3 1 Protective fuse of the battery type T 2 A missing or melted e Check that the power absorbed by the apparatus is lower than 1 8 A d c If the value is higher search for the cause e Once the cause has been eliminated replace the fuse with an equivalent type 6 3 2 Damaged battery e The battery emitted some acid e tis swallen e Cannot be recharged Replace it with an equivalent one as to type voltage and capacity 6 3 3 Battery check To check the
20. apparatus is returned e Please remember that this apparatus has been designed using CMOS technology Most of the electronic components belongs to the ELECTROSTATIC SENSITIVE DEVICES ESD family Therefore it is necessary to follow specific working procedures Appendix A describes the special procedures required in the treatment of electrostatic sensitive devices ESD The manufacturer refuses all responsibility for any damage undergone by the apparatus caused by inadequate or non existent working procedure necessary in treating with ESD devices NOTE Transportation and packaging of the apparatus not in its original packaging or an incorrectly packaged apparatus frees the manufacturers of any responsibility with regard to damages to the apparatus and its accessories thus resulting in the annulment of the warranty f H amp C MEDICAL DEVICES S p A reserves to itself the right to modify at any time and without any advance notice the product or this manual g Before starting the assistance service please ready the entire content of this manual AFTER SALES SERVICE 6 HE MEDICAL DEVICES 1 TECHNICAL CHARACTERISTICS Power supply from mains Max input Mains power supply protection Built in power supply Battery protection Applied part Protection from defibrillation Input dynamics Input impedance Common rejection Frequency response Time constant Acquisition Leads Signal memory Sensitivity manual automatic
21. chapter 7 8 If the above conditions do not apply the mother board is damaged 6 6 2 The failed control of the black notch on the paper and the related malfunctions in automatic mode may depend on FC2 sensor is dirty clean with a cloth the slide above it Faulty connection between keyboard card and mother board Check the flexstrip The calibration voltage of the sensor is not correct as per chapter 8 2 Damaged sensor Replace the sensors card as per chapter 7 8 If the above conditions do not apply the mother board is damaged AFTER SALES SERVICE 27 HE MEDICAL DEVICES 6 7 MALFUNCTIONS CAUSED BY DEFECTIVE PAPER DRIVING FLOW ANALYSIS AND TECHNICAL DESCRIPTION refer to electrical diagram file name M SPEED Paper doesn t run Paper runs irregularly Check paper guid roller and Check paper compartment lid ie paper feed Check the presence of paper Check kymograph gears spindle Check kymograph connector Check kymograph gears Check kymograph power supply and control circuit Check kymograph stroboscope sensor Check kymograph power Replace mother board MAE supply and control circuit Replace mother board 6 7 1 The paper does not run AFTER SALES SERVICE 28 SPA MEDICAL DEVICES The main causes are due to e Paper lid badly closed correctly insert it e The teeth of either the paper lid or the motor group gear are damaged crushed replace either paper lid or motor group e Stroboscopic disc ei
22. condensers may discharge on components or groups of components causing permanent damage e Proceed in the opposite direction to reassemble the mother board paying attention to insert the mains plug vertically in the dedicated slots so that its fixing wings correctly lock on the internal wall of the case NOTE When the insulations and auxiliary fixing elements are not restored or restored wrongly the safety characteristics of the apparatus fail and the producer is released from whatsoever responsibility g The mother board replacement requires the calibration of the paper sliding speed and the calibration of the two paper and notch presence sensors 7 4 DISASSEMBLING THE BATTERY table T 6 To replace the battery table T 6 proceed as follows a Open the equipment as mentioned at chapter 7 2 b Follow the directions of chapter 7 3 points a b relevant to the movement of the card to reach the battery Removing the card completely is unnecessary if desired proceed as per point e c Remove the two fixing rods of the battery lifting them upwards after unscrewing the respective fixing screws d Install in the same position a new 12 V 0 8 Ah lead battery equivalent as to dimensions and power to the original one e In reverse sequence reassemble and fix the two battery fixing rods reposition and fix the mother board taking care to connect it first to the battery power socket in the correct polarity Pay attention
23. dling and working with electronic components sensitive to electrostatic discharges precautions must be taken against electrostatic discharges ELECTROSTATIC SENSITIVE DEVICE ESD 2 PROCEDURE 2 1 WORKING AREA PROTECTION 2 1 1 INDIVIDUAL PROTECTION SYSTEM The personnel dealing with control storage transportation and installation procedures should be connected to ground by means of the special conductive bracelet in accordance with safety regulations Should it not be possible to use this procedure the operator must use appropriate antistatic shoes 2 1 2 PROTECTION OF THE WORKING EQUIPMENT AND INSTRUMENTS All working equipment should be grounded Tables working benches and other surfaces on which the components are handled should be covered with conductive material and should be grounded All tables and working benches should be covered with a layer of conductive material and should be grounded The repair man himself should be connected to ground with the special bracelet in accordance with safety regulations 2 2 PACKAGING AND TRANSPORT The material should be held in special antistatic bags or containers and should be labelled according to MIL STD 129J The containers should guarantee adequate protection from shocks and handling during transportation 2 3 STORAGE All ESD components should be stored in their original boxes and placed in special metallic containers During warehouse storage the electronic components should b
24. e notch detection and paper sliding speed START 100 electrocardiograph is supplied duly calibrated from the factory during the installation at the users some non volatile data i e those data saved in the RAM even when the apparatus is off can be set e g user s data patient s data language printing channels number of automatically printed pages analysis type filter type and functions programmable by the installation technician as described in the guide to installation manual The equipment is delivered to the distributor without the d c protection fuse which can be reached from the case bottom in order to avoid a damaging discharge of the battery after a long period of storage or inactivity In such condition at the first start up proceed according to the following sequence 1 Install the fuse 2 Perform the apparatus self test by depressing in sequence the ON key and within 3 seconds the MAN key with mains power supply The self test operation automatically performs the apparatus reset and the configuration set up in the English language 3 Carry out the desired programming 4 After leaving step 3 the apparatus is ready for use NOTE The sequence described above shall be performed 1 Atthe FIRST INSTALLATION start up and or eproms replacement 2 After installing and or replacing the power supply fuse if any data stored in the memory have been lost 3 After replacing the battery or else
25. e efficiency of the connection between thermal head and mother board flexstrip e Check while the printing process is active the power supply to the thermal head Vset 25 V d c 1 measured on either drain Q7 or pin 1 of J4 depending on the type of signal being printed during the printing process e Check the existence of either an electrocardiographic or instrumental signal e If above points check activate the printing function of the apparatus and check on connector J4 a The presence of a 1 5 Mhz clock on pin 5 see Fig 1 b The presence of logic signals on the lines BDIP on pin 7 data and LAPT on pin 6 see Fig 1 c The presence of a square strobe wave signal on pin 4 with a frequency of 1 Khz see Fig 1 If there is still no print out when such signals are present as per Figure 1 replace the thermal head group If on the contrary the signals do not correspond to Figures 1 the failure is located in the mother board which needs being replaced 6 5 2 Anomalous print out Electrical check e If the prin out is too intense at any velocity check that Vset on pin 1 of J4 is not higher than 28 Vdc maximum supply voltage of the thermal head if Vset is higher the control circuit is damaged see Q2 Q3 Q4 Q7 e f the duration of the strobe impulse on pin 4 of J4 is higher than approximately 700 msec see Fig 2 the mother board is damaged and needs being replaced e f the apparatus regularly operates and the pr
26. e kept in the original packaging Possible containers should be exclusively metallic material and or conductive material In the event of direct handling the personnel should adopt all those precautions described in 2 1 4 AFTER SALES SERVICE 45 SPA MEDICAL DEVICES 2 4 TRANSPORT OF THE ELECTRONIC COMPONENT CARDS During transportation phases the cards should be deposited in the special antistatic containers 2 5 ESD COMPONENT IDENTIFICATION Each component sensitive to electrostatic discharges is identified with the ESD initials In the Warehouse area the containers are labelled with the appropriate symbol 2 6 WARNINGS AND RESPONSIBILITY Please follow all the instructions given in this procedure when dealing with ESD components The manufacturer is not responsible for any damage to the apparatus caused by insufficient or inadequate treatment handling or working methods AFTER SALES SERVICE 46 SPA MEDICAL DEVICES ILLUSTRATED TABLES TABLE T1 VIEW OF THE UPPER CASE TABLE T2 SIDE VIEWS TABLE T3 VIEW OF THE LOWER CASE TABLE T4 INNER VIEW OF THE LOWER CASE TABLE T5 INNER VIEW OF THE UPPER CASE TABLE T6 DETAILED INNER VIEW OF THE UPPER CASE TABLE T7 DETAILED VIEW OF THE WRITING SYSTEM AFTER SALES SERVICE 47
27. ector under the mother board stuck to the bottom of the case table T4 NOTE The safety characteristics see chapter 4 shall be checked after every opening and or repairing of the apparatus as well as before its redelivery to the client 7 2 OPENING AND CLOSING THE APPARATUS table T 5 The following procedure is recommeded a put the equipment on a soft working bench keeping the case removable bottom upward unscrew and remove the eight TSP 2 5mm x 8mm screws table T3 ref 1 b lift upward and disconnect the mobile bottom of the case NOTE In case the apparatus is power supplied while open please remind that the inside is conductive Therefore pay special attention to the uncovered points where the primary mains voltage and the secondary voltage of the cards supplying circuits exist in order to avoid causing permanent damages To close the equipment again follow the above directions in the opposite direction 7 3 DISASSEMBLING THE MOTHER BOARD table T 5 a proceed as mentioned at chapter 7 2 opening the apparatus b unscrew and remove the six M4 x 6 x 3 25 brass nuts table T 5 Lift the card above the paper box by 1 cm and interpose through that spacing an insulating sheet along the whole conductive case Once released the card in such area by exerting an upward pressure on the power supply plug and the patient connector contemporaneously lift it up again by a few centimeters and unthread the socket of the wire c
28. efficiency of a battery having plate data 12 V 0 7 0 8 Ah proceed as follows e Take it out from the case as described in chapter 7 4 e Power it with an external 13 65 V voltage power supply checking whether it absorbs any current Such current depends on the charge conditions e After recharging it for 15 hours discharge it through a resistance with a 0 7 0 8 Ah current If the voltage remains higher than 11 Volt for about 30 minutes the battery may be still considered to be efficient if not its charging capacity is very limited and its replacement is advisable 6 3 4 Battery recharge failed due to the 12 V power supply check e Refer to chapter 5 6 Supply circuit from mains Transformer 230 22 V 115 22 V Outlet bridge 30 Vdc 5 on pin 4 of the switching IC29 controller Presence of about 14 V 0 5 measured on R4 anode side of diode D54 The correct value of such voltage indicates a regular operation of the switching IC29 controller e ON OFF circuit check whether depressing the ON OFF key of the keyboard with the stand by switch closed a 13 65 V voltage appear on Q8 drain If not the mother board is to be considered damaged AFTER SALES SERVICE 22 SPA MEDICAL DEVICES 6 4 THE APPARATUS DOES NOT CORRECTLY ACCEPT THE KEYBOARD COMMANDS FLOW ANALYSIS AND TECHNICAL DESCRIPTION refer to electrical diagram file name TAS START EQUIPMENT DOESN T ACCEPT COMMANDS FROM THE KEYBOARD Check flat and connector Check
29. ence and the paging black notch 2 6 PRINTER MECHANICAL GROUP COMPLETE WITH THERMAL HEAD This group consists of the supporting plate for the printer thermal head and the mechanical components required for its correct positioning A complete sparee group is provided 2 7 MECHANICAL GROUP OF THE PAPER DRIVING SYSTEM The group consists of the driving motor complete with support and gears A complete spare group is provided 2 8 PROTECTION FROM DEFIBRILLATION The apparatus has a built in protection from the defibrillator discharges Therefore this apparatus allows the use of patient cables not protected from defibrillation and supplied by the manufacturer AFTER SALES SERVICE 11 SPA MEDICAL DEVICES 3 INPUTS AND OUTPUTS START 100 does not allow any connection to other external apparatus 3 1 CONNECTION TO THE PATIENT INPUT SOCKET table T2 OOOOOOGOD OOOOOOO Socket seen from the connection side Pin 1 IN C2 C2 electrode Pin 2 IN C3 C3 electrode Pin 3 IN C4 C4 electrode Pin 4 IN C5 C5 electrode Pin 5 IN C6 C6 electrode Pin 6 IAGND Pin 7 NC not connected Pin 8 NC not connected Pin 9 IN R R electrode Pin 10 IN L L electrode Pin 11 IN F F electrode Pin 12 IN C1 C1 electrode Pin 13 NC not connected Pin 14 IN N N electrode Pin 15 NC not connected The inputs have the following characteristics a Sensitivity 1 mV 5 10 20 mm depending on the selected
30. ide of the apparatus To replace it in case of wear lift it up on one corner by means of a thin blade tool and tear it away from the case If any adhesive remains on the case remove it using the finger tips To install a new membrane centre its corners inside the housing and exert a slight pressure on the whole surface 7 11 MAINS FUSES The mains fuses can be reached from the outside as they are positioned below the power supply plug on the rear part of the apparatus table T2 In order to replace them exert a pressure on the two plastic wings of its container using a pair of tweezers The protection fuses are T 0 16 A with 220 240V power supply and T 0 315 A with 110 120 V power supply NOTE Use standard fuses Those selected by the manufacturer are the recommended ones see the spare parts list chapter 10 NOTE FUSES MELTING MAY BE DUE TO EXCESSIVE POWER INPUT AS WELL AS TO A WRONG USE OF OR POWER SUPPLY TO THE APPARATUS IN ANY CASE CHECK THE APPARATUS TO IDENTIFY THE REASON FOR SUCH FAILURE WARNING ALWAYS REPLACE THE FUSES KEEPING THE MAINS CABLE DISCONNECTED FROM THE APPARATUS POWER PLUG AFTER SALES SERVICE 34 SPA MEDICAL DEVICES 8 CALIBRATIONS 8 1 GENERAL INFORMATION This apparatus has an automatic calibration system The only calibrations required after disassembling the apparatus for checks or repairs and related to the mother board exclusively are those for the sensors of paper presenc
31. ieces 4 A fuse SLO BLO SMD 10 pieces Paper feed complete ON OFF switch Internal cables kit EPROM parameters 1st series kit EPROM parameters 2nd series kit Insulating membrane kit SMD led 8 green pcs 2 yellow pcs 10 pieces Lower case complete Upper case complete Paper spindle 3 C CPU acquisition board START 100 P 220 V hardware Sensors board Keyboard Printer complete Keyboard membrane Key for the keyboard 10 pieces 14 VA 230 22 V transformer Table 10 1 40 List of spare parts for SPA MEDICAL DEVICES START 100 P 110 120V code 60500059 Code Description 69700528 69701065 69700197 69701070 69700331 69701071 69701072 69701083 69701086 69701074 69701027 69701075 69701076 69700162 69701096 69701078 69701079 69701080 69701099 69700932 69701082 AFTER SALES SERVICE 12V 0 8 Ah battery Kymograph T 2 A fuse 10 pieces 4 A fuse SLO BLO SMD 10 pieces T 0 315 A fuse 10 pieces Paper feed complete ON OFF switch Internal cables kit EPROM parameters 2nd series kit Insulating membrane kit SMD led 8 green pcs 2 yellow pcs 10 pieces Lower case complete Upper case complete Paper spindle 3 C CPU acquisition board START 100 P 120 V hardware Sensors board Keyboard Printer complete Keyboard membrane Key for the keyboard 10 pieces 14 VA 230 22 V transformer Table 10 2 41 List of spare parts for SPA MEDICAL DEVICES START 100 H 220
32. ied out on the mother board AFTER SALES SERVICE 33 SPA MEDICAL DEVICES 7 9 DISASSEMBLING THE PAPER LID table T 1 The paper lid system is a mechanical device located in the case and accessible from the outside which is actuated by the apparatus motor and lets the thermo sensitive paper slide It is housed above the paper box and covers the latter entirely To remove this particular part proceed as follows a Exert a pressure on the dedicated release hook located in the middle of the case front where the paper comes out from and extract it by inclining it upwards b Disassembly ot this group is necessary before inserting a new paper roll when cleaning the roller and in any case before replacement or disassembly of the thermal head c To reassemble the device it is sufficient to let it slide into its housing keeping the rubber roller towards the apparatus inside and holding it lifted up from the opposite end As soon as inserted exert a slight pressure downwards on the lifted end so as to make it click NOTE If the roller is not clean and the paper lid is either badly inserted or badly fixed the paper driving will be difficult and an apparatus malfunction will occur 7 10 DISASSEMBLING AND REPLACING THE KEYBOARD MEMBRANE table T 1 The keyboard membrane is an elastic membrane located above the keyboard card which allows depressing the control keys of the latter This self adhesive plate is stuck on the front s
33. int out disappears check the correct operation of the battery Mechanical check e If the pressure among the thermal head paper and driving platen is insufficient check fixing of the printer on the case and pay attention when tightening the two screws to keep the thermal head group well and homogeneously forward pressed against the box containing the paper If the printer is fixed in an inclined position the writing is irregular e Check that the paper driving platen does not rotate eccentrically if this happens replace the paper lid AFTER SALES SERVICE 25 SPA MEDICAL DEVICES 6 6 MALFUNCTIONS DURING PAGING AND PAPER PRESENCE SIGNALLING FLOW ANALYSIS AND TECHNICAL DESCRIPTION refer to electrical diagram file name M SPEED PAPER PAGING AND PAPER PRESENCE Ne ndicaboniciend ol paper Not correct automatic paging no automatic stop when end of paper no printout in AUTO Mode Check paper sensor Check paper sensor Defective mother board Check paper sensor system Replace mother board Defective mother board Replace mother board AFTER SALES SERVICE 26 SPA MEDICAL DEVICES 6 6 1 The failed control of paper over condition may depend on e FC1 sensor is dirty clean with a cloth the slide above it Faulty connection between keyboard card and mother board Check the flexstrip The calibration voltage of the sensor is not correct as per chapter 8 2 Damaged sensor Replace the sensors card as per
34. itch the apparatus on and adjust the AR1 trimmer to obtain a 4 Vdc 0 3 Volt voltage table T 6 ref 2 e insert the paper close the lid and check that the voltage is 1 Vdc 0 Volt 0 3 Volt if necessary fine tune the trimmer and repeat the item d test without inserting the paper Calibrating the notch presence sensor a connect the negative pole of the voltmeter to the DGND earth b connect the positive pole of the voltmeter to either pin 5 of the integrated circuit IC36 or the dedicated IC40 contact c remove the paper if inserted and close the lid d switch the apparatus on and adjust AR2 trimmer to obtain 4 Vdc 0 3 V voltage table T 6 ref 3 e insert the paper close the lid and check that when the paper is NOT present the voltage is 1 Vdc 0 Volt 0 3 Volt if necessary fine tune the trimmer and repeat the test of item d without the paper 8 3 CALIBRATING THE PAPER SPEED refer to electrical diagram file name M SPEED The calibration of the paper speed must be carried out with 12 Volt power supply from battery as described in chaoter 5 4 Start recording a 1 impulse sec frequency signal at 25 mm sec and calibrate it by means of AR3 potentiometer Table T 6 ref 1 as accurately as possible tolerance 5 Then start another recording at 50 mm sec speed and check that it is in the 5 tolerance too if not fine tune the calibration by means of the AR3 potentiometer and check again at 25 mm sec
35. lete Paper spindle 3 C CPU acquisition card START 100 H 120 V hardware Sensors board Keyboard card Printer complete Keyboard membrane Key for the keyboard 10 pieces 14 VA 230 22 V transformer Table 10 4 43 SPA MEDICAL DEVICES SPECIAL NOTE When ordering spare parts for mother board and software keep in mind the following a b c Apparatus START 100 P 220 240 V first series No 50 ECG START 100 code 60500052 Lot No 00099 From number LHIF 001 to number LHIF002 From number LHZM 001 to number LHZM046 From number LHLA 001 to number LHLA002 On these apparatus it is possible replacing the first series EPROM kit code 69701073 or else replacing the CPU acquisition mother board second series code 69701077 with EPROM START 100 kit second series code 69701086 Other apparatus START 100 P H On these apparatus it is possible replacing indipendently the CPU acquisition mother board and the EPROM kit foreseen in the respective spare parts list Never replace EPROM kits in the apparatus with a revision status lower than the installed one AFTER SALES SERVICE 44 SPA MEDICAL DEVICES APPENDIX A 1 PROCEDURES FOR THE HANDLING AND STORAGE OF ELECTRONIC COMPONENTS SENSITIVE TO ELECTROSTATIC DISCHARGES ESD 1 1 GENERAL INFORMATION All modern electronic components and in particular those based on CMOS technology can be irreparably damaged by even modest electrostatic discharges When han
36. ls of thermosensitive paper provided with grid It is supplied in two different models START 100 P 110 120 Vac 220 240 Vac This model in addition to recording the ECG grants the possibility of calculating the main electrocardiographic parameters with either brief or extended report recording in both manual and automatic mode with copy possibility in printing mode 3 and or 6 channels selecting the language Italian English German French Spanish Russian selecting the 50 55 60 Hz filters automatically numbering the pages by either terns or six lines groups 1 or 2 inserting the user name START 100 H 110 120 Vac 220 240 Vac This model differs from the previous one in that it features the implementation of the interpreting program instead of the parameters calculation INSTALLATION PROGRAM The access to the programming menus can be achieved in two steps The first one takes place by depressing the STOP key within 3 seconds after switching the apparatus on If the procedure has been correctly performed all the leds relevant to the velocity amplitude and filters keys will blink In such condition the AUTO STOP SPEED keys shall be depressed in sequence The menu activation is very clearly guided on the print outs For more detailed information please refer to the installation instructions REGISTER NUMBER The label with the apparatus identification data is placed o
37. modified 50 55 60 Hz notch digital filter Anti drift 0 5 Hz pass high and linear phase digital filter Membrane type with 8 functional and numerical keys 9 Function indicators HES ECG program developed by Medizinische Hochschule Hannover Germany Developed by Istituto di Fisiologia Clinica C N R in Pisa Italy Manual real time acquisition Automatic isochronous Continuous operation Built in battery 30 minutes in the 3 channel mode 10 mm mV 25 mm sec 10 Hz p v Built in battery 4h 80 12h 100 IP20 Environmental conditions Operation Transport and storage Dimensions Weight Compliance with standards HE MEDICAL DEVICES Ambient temperature 10 to 40 Relative humidity 25 to 95 without condensation Atmospheric pressure 700 hPa to 1060 hPa Ambient temperature 10 C to 40 C Relative humidity 10 to 95 without condensation Atmospheric pressure 500 hPa to 1060 hPa 247 x 69 x 262 mm width x height x depth 2 4 Kg EN 60601 1 1990 EN 60601 1 1990 A1 1993 EN 60601 1 1990 A2 1995 General standards for the electromedical equipment safety EN 60601 1 2 1993 Standards related to the electromagnetic compatlibility of electromedical equipment IEC 601 2 25 1993 Special safety standards for electrocardiographs IEC 62D CO 6 1978 Special performance standards for electrocardiographs NOTE REGARDING THE PROTECTION The maximum applicable voltage to inputs and
38. n 1 of IC31 If the stroboscopic sensor is damaged no signal will be noticed therefore replace the motor group Inthe second case Q1 transistor is short circuited replace it with an equivalent one e If the paper velocity is irregular check The efficiency of AR3 calibration potentiometer refer to chapter 8 3 relevant to velocity calibration should it show any false contact replace either the potentiometer itself or the mother board The efficiency of the motor control circuit as described in above paragraphs 6 7 1 and 6 7 2 if the circuit is found damaged replace the mother board AFTER SALES SERVICE 29 SPA MEDICAL DEVICES 6 8 ILLUSTRATION OF THE POWER SUPPLY VOLTAGE FLOW ANALYSIS AND TECHNICAL DESCRIPTION refer to electrical diagram file name POW SUP and ACCU 12 V CHECK OF THE POWER SUPPLY VOLTAGES Multivoltage power supply Insulated circuits 5 V for analogic circuits 5 V for digital circuits 12 V d c battery power supply 12V 0 7 0 8 Ah battery VMB 3 6 V for memory power Not insulated circuits Vset 25 V 5V If detected values do not correspond the mother board is defective Replace mother board Illustration of the functions relevant to the power supply voltages e The section relevant to the power supply and battery recharge has already been illustrated in chapter 6 3 e The voltage VBM 3 6 V is supplied to the static RAM
39. n the movable bottom Table T3 The label is subdivided into three parts 1 The upper part gives the sellers data and the apparatus trademark 2 The middle part gives The model the characteristics of the power supply in Volt The code number the frequency in Hz The serial number the absorption in Amperes CE mark AFTER SALES SERVICE 4 SPA MEDICAL DEVICES 3 The lower part gives the language or langages the manufacturer s identification data NOTE Always use the series code and the apparatus code when communicating with the Seller or with the Assistance Service CE MARKING The CE marking identification label is placed on the movable bottom and defines the type of apparatus conformity CE Marking only it defines conformity to European Community Directive 89 336 relative to electromagnetic compatibility CE 0470 CE Marking 0470 it defines conformity to European Community Directive 93 42 relative to the safety of medical devices The number 0470 indicates the homology number of the Nemko Certified Body AIM OF THE MANUAL The aim of this manual is the following a to give a description of how the unit operates b to give a description of the procedures necessary to carry out a complete test of the apparatus c to give a description of the procedures necessary to carry out the safety tests according to the IEC safety regulations d to identify and isolate blocks of operational breakdowns e
40. nection socket with earthing functions and equipotential connection table T 2 The equipotential connection must be carried out according to the instructions and using the materials listed hereunder Required material e cylindrical head M5X10 mm type screw e 5 mm internal diameter washer e 5 mm internal diameter cable terminal e wire with overall resistance lower than 0 1 Ohm and 1 5 cm minimum section Instructions e prepare and solder the wire to the cable terminal e insert the washer and the cable terminal in the screw e fix and adequately tighten the screw in the equipotential threaded bushing SAFETY NOTE The replacement of the components belonging to the mains power supply section may only be carried out using identical components to the original ones homologated by the manufacturer or else the safety features of the apparatus will be lost 2 3 2 POWER SUPPLY TO INTERMEDIATE CIRCUITS This section consists of a DC DC converter and a high frequency transformer generating the following voltages e 5 V to supply the control logic e 24 V to supply the printer thermal head e 5 V to supply the insulated part 2 3 3 INTERMEDIATE CIRCUITS FOR CONTROL AND INTERFACING This section includes the microprocessor system controlling the operation of the whole apparatus and the external interfaces of the mother board such as the keyboard and the serial interface RS232 the analog inputs and outputs the remote control
41. onnected to the battery After this operation it becomes possible to rotate the card itself by 180 by means of the hinge along the paper holding box bringing it to an horizontal position AFTER SALES SERVICE 31 HE MEDICAL DEVICES At the end of the rotation it is advisable to lean the part overhanging from the case on a Suitable insulated rest so as to avoid any traction on the connected cables and flats Under these conditions it is already possible to perform some preliminary checks without power supply c In order to achieve a more adequate functional position from the position reached rotate the case by 90 towards the card leaving it in a vertical rest along the paper outlet side d In case of checks performed with mains power supply pay particular attention not to come into contact with live parts not insulated e To either disassemble or replace the mother board completely disconnect as follows the flat of the keyboard card the flat of the sensors card the flat of the thermal head the connector with the connecting wires to the motor group the faston with the yellow green wire of the printer earthing connection Always remember to perform all the operations as well as handling the card only after earthing yourselves with a suitable protected armlet Remember that the inside of the case is conductive Remember to put the card on insulated parts in order to avoid that residual voltages on the
42. r group paying particular attention to positioning all mechanical items such as screws washers etc besides remember to carry out the earthing connection under the fixing screw of the frame supporting the thermal head with the mother board and during the fastening keep the group forced against the paper holding box d In order to achieve a long life of the thermal head it is advisable to exclusively use the thermo sensitive paper DOT CARD recommended by the manufacturer in 130 mm high rolls The ordering code is stamped on the bottom edge of the paper itself e The thermal head is highly sensitive to electrostatic potentials therefore the operational procedures described in appendix A shall be followed in any case f The replacement of the printing group requires no calibration 7 8 DISASSEMBLING THE PAPER AND NOTCH SENSORS BOARD table T 6 Proceed as follows a Follow the directions given in chapter 7 3 points a b e to open the apparatus and remove the mother board b To remove the sensors card force it upward with a suitable tool The card is stuck in its housing inside the upper case c To replace the card it is necessary cleaning its housing correctly positioning it inside its housing with the flat outlet facing the paper holder and sticking it by means of an instantaneous adhesive d Toclose the apparatus follow the reverse operations e After replacement the sensors card requires calibration to be carr
43. sensitivity b Input impedance higher than 100 MOhm for each electrode c Input dynamic 300 mV at 0 Hz 6 4 mV in the passing through band d The inputs are protected from defibrillation AFTER SALES SERVICE 12 SPA MEDICAL DEVICES 4 SAFETY CHARACTERISTICS CONTROL The safety regulation expects two important tests a The applied voltage test it verifies the insulating efficiency of the power supply circuits and those relative to the patient connections b The leakage current test it measures the value of the leakage currents in relation to patient safety NOTE All safety tests should be performed according to IEC 601 1 regulations paragraphs 19 20 4 1 NECESSARY INSTRUMENTS a Insulating strength analyser model U28 M Elektrotechn Laboratorium D 7015 Korntal Germany or its equivalent b Leakage current analyser model AMPLAID ST 10 Amplifon Division S p A Italy or model METRON QA 80 Electrical Safety Analyser or model BIO TEK 601 PRO Amplisim Division srl Italy or its equivalents 4 2 APPLIED VOLTAGE TEST The test should be carried out in a suitable location in accordance with safety regulations by using the instrument 4 1 a This test must be carried out only in those apparatuses in which components with special insulating characteristics have been substituted a power supply transformers b transformer on the TR1 voltage converter c optoinsulators FC1 FC7 of the mother
44. ser s manual of the instrument itself and verify that the values of the leakage currents measured are less than or equal to those reported in Table IV AFTER SALES SERVICE 14 SPA MEDICAL DEVICES IEC REGULATIONS 60601 1 1990 60601 2 25 1993 Table IV Permanent admissible values for the leakage currents and for the auxiliary currents in the patient in mA N C S F C Leakage current towards ground Leakage current in the case Leakage current in the patient 0 01 Leakage current in the patient with mains voltage in the applied part 0 05 N C Usual condition EE e S F C First fault condition AFTER SALES SERVICE 15 5 SPA MEDICAL DEVICES CONTROL OF THE APPARATUS MAIN TECHNICAL CHARACTERISTICS 5 1 REQUIRED INSTRUMENTS The instrumentation required includes a b c mV impulse generator with the following minimum characteristics impulse width 1mV 3 impulse repetition rate 1 Hz tolerance rate 1 max impulse rise time 1 ms low frequency sinusoidal wave generator accessory ECG simulator 5 2 SENSITIVITY TEST Proceed as follows a b c d e f g prearrange the apparatus for the recording of 3 signals with leads V1 V3 and sensitivity of 20 mm mV connect the patient cable to the apparatus connect the C1 C6 terminals of the patient cable connected to the apparatus to the positive pole of the instrument 5 1 a connect
45. sitivity f carry out a recording and set the generator width in such a way as to obtain a 10 mm swing in the recorded signal h vary the generator frequency from 0 5Hz to 100Hz keeping the width constant g check that the frequency response is in agreement with Table 5 5 FILTERS FREQUENCY PARAMETERS Hz WIDTH mm min 9 0 max 10 5 min 7 0 max 10 5 max 9 0 min 9 0 max 10 5 min 7 0 max 7 2 min 3 0 max 4 5 min 8 0 max 10 0 max 0 5 max 2 0 TABLE 5 5 5 6 CHECK OF POWER SUPPLY AND BATTERY RECHARGE Proceed as follows a open the apparatus as mentioned in chapter 7 2 supply it through the mains paying attention to keep the live parts duly insulated b checking the supplied voltage replace the battery with a 1 KOhm 0 25 W resistor and measure the voltage at its terminals it must correspond to 13 65 V 5 c checking the supplied current replace the battery with a load ranging from 0 Ohm to 30 Ohm 15 W and measure the supplied voltage and current check that with a 12 Vdc voltage the current is 0 9 A 10 d check the discharged battery indication still meeting the polarities replace the battery with a power supply capable of supplying 5A with a voltage ranging from 0 to 15 Vdc switch the apparatus on and check that the yellow led indicating a discharged battery condition lights up with 10 75Vdc 2 AFTER SALES SERVICE 18 SPA MEDICAL DEVICES 5 7 TECHNICAL SELF TEST
46. ther warped or damaged replace motor group e Check the connection motor mother board if damaged replace the kymograph e Check the motor power supply and control system proceeding as follows With reference to the electrical diagram file name M SPEED check the presence of 12 Vdc on the emitter of Q1 check the presence of 7 5 Vdc on pin 9 of IC3 check the logic status of the ACV BCV controls according to the table reported in the electrical diagram if correct values are noticed check the working condition of the stroboscopic sensor by manually turning the stroboscopic disc and checking on IC31 the presence of a sinusoidal trapezoidal signal with variable frequency as per Fig 2 it depends on the set velocity if no signal is noticed the stroboscopic sensor is damaged therefore replace the kymograph If on the contrary a 0 6 V signal is noticed as per Fig 2 replace the mother board 6 7 2 The paper runs irregularly refer to electrical diagram of the mother board file name M SPEED The faulty driving of paper also causes some mulfunctions during the printing process and the notch checking process The main causes are due to e Perform all the mechanical checks described in above chapter 6 7 1 e f the motor does not control the speed any longer and takes to spin along then either the stroboscopic control is missing or Q1 transistor is short circuited In the first case check the signal on pi
47. tion phase completed Leds out in isochronous Parameters calculation or analysis phase print velocity sensitivity filters AFTER SALES SERVICE 37 SPA MEDICAL DEVICES 9 3 INSPECTION FREQUENCY Periodical inspections and checks of both the apparatus and its accessories are required to assure a safe and long duration Table 9 3 indicates the type required and the scheduling of the check operations for the standard use of the recorder about 4000 ECG recordings year SAFETY CHECK Type of intervention If the apparatus is used as an electrocardiograph only check of the dispersion currents every 2 years If the apparatus is used for intracardiac applications check of the dispersion currents every year NOTE This periodic check must be carried out according to the directions of the National safety standards of the State where the apparatus works However it is advisable to perform the tests relevant to the dispersion currents at least once per year FUNCTIONAL CONTROL Frequency every 3 months every 3 months every 3 months every 3 months once per year once per year once per year cleaning of paper housing and check of paper notch once per year presence sensors check of patient cables and electrodes once per year battery check once per year once per year AFTER SALES SERVICE 38 SPA MEDICAL DEVICES 9 4 CLEANING THE THERMAL HEAD 9 4 1 FOREWORD The periodic cleaning of the thermal he
48. to correctly position the insulating plate located on the patient connector reinstall and fix the mobile bottom AFTER SALES SERVICE 32 SPA MEDICAL DEVICES 7 5 DISASSEMBLING THE KEYBOARD To disassemble the keyboard it is necessary to proceed as follows a Proceed as per chapter 7 3 points a b e to open and remove the mother board of the apparatus b Unscrew the 6 fixing screws and remove the keyboard lifting it upward c Proceed in the opposite direction to reassemble the board and close the apparatus 7 6 DISASSEMBLING THE PAPER DRIVING MOTOR GROUP table T 6 Proceed as follows a Take off the paper lid and the paper roll of the apparatus b Proceed as per chapter 7 3 points a b e to open and remove the mother board c Take off the 2 fixing screws and lift the motor group up d The replacement of the motor requires calibrating the paper sliding speed e Proceed in the opposite direction to reassemble the motor group and close the apparatus 7 7 DISASSEMBLING THE PRINTER GROUP table T 6 Proceed as follows a Follow the directions of chapter 7 3 points a b e to open and remove the mother board of the apparatus and those of chapter 7 6 for the removal of the motor group b Take off the 2 fixing screws of the printer group and remove it from its housing paying attention not to damege the thermel head dots with hard items c Proceed in the opposite direction to install the printe
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