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Single Channel Automatic ECG Machine Service Manual Model: ECG-11A/B

CMICS Medical Electronic Instrument Factory


1 Features -----------------------------------------------------------------------------------2 Theory and Structure --------------------------------------------------------------------2.1 The Power Supply Module -----------------------------------------------------------2.2 The Keyboard Control Module ------------------------------------------------------2.3 The Pre-amplification Module -------------------------------------------------------2.4 The Amplification Module -----------------------------------------------------------2.5 Mechanical Structure -----------------------------------------------------------------3 Adjustment and Maintenance ----------------------------------------------------------3.1 Check and Calibration ----------------------------------------------------------------3.1.1 Stylus Temperature Calibration ---------------------------------------------------3.1.2 Damp Calibration -------------------------------------------------------------------3.1.3 Gain Adjustment --------------------------------------------------------------------3.2 Operating Instruction -----------------------------------------------------------------3.2.1 Preparation ---------------------------------------------------------------------------3.2.2 Lead Connection --------------------------------------------------------------------3.2.3 Checking -----------------------------------------------------------------------------3.2.4 Recording ----------------------------------------------------------------------------3.3 Cautions ---------------------------------------------------------------------------------3.4 Periodic Maintenance -----------------------------------------------------------------4 Troubleshooting --------------------------------------------------------------------------4.1 The Pre-amplification Module -------------------------------------------------------4.2 The Keyboard Control Module ------------------------------------------------------Appendix -------------------------------------------------------------------------------------

3 3 3 5 7 8 10 11 11 11 11 12 12 12 12 12 12 13 13 14 14 16 18

Notes: Operation instructions subject to change without notice.

1 Features Electrocardiograph (hereinafter refers to ECG) is a medically precise instrument for recording real time cardiac activity and diagnosing heart problems. Model ECG-11A/B features automatic lead change. It was developed in 1988 by combination of advanced position feedback recording system with technical advantage of similar products in China and from abroad. It is suitable for clinical application in towns and rural areas. ECG-11A/B is characterized b compact structure, elegant appearance, portability, and shielding protection. It is the very instrument for patrolling examination and the like. Reasonable design of ECG-11A/B circuitry includes feasible components, isolated input circuit, dedicated integrated-circuit (SDJ-1), and advanced position feedback recording system. The isolated input circuit meets requirements of IEC safety standard. The advanced position feedback recording system features consistent linearity, clear waveform trace, high feasibility, and low power dissipation in addition to convenient adjustment of stylus temperature, damp, and sensitivity. ECG-11A/B is equipped with filters HUM and EMG to guarantee operation in face of powerful interference. Lead disconnection indicator can indicate lead status and prompt the operator to take action whenever lead-disconnection happens. ECG-11A/B features automatic change in turn of 12 leads, automatic calibration, and automatic power down. Operating in automatic mode, the instrument automatically prints out a calibrating square wave subsequent to every lead change. This function helps physician to discriminate lead change and waveform as well to diagnose heart problems. The instrument is provided with standard accessories including patient cable and two sets of electrodes. 2 Theory and Structure ECG-11A/B comprises a pre-amplification module, keyboard control module, power supply module, and a amplification module. The pre-amplification module functions complete linear amplification of the week bio-electric signal acquired from human body surface by ways of electrodes. The amplification module acts to carry out power amplification on the amplified signal from pre-amplification module before sending it to the recording system for printing out. The keyboard control module works to generate commanding signals necessary for the instrument to operate. Operating keys on the panel can set status of the instrument. Following are descriptions of theory of operation for ECG-11A/B. 2.1 The Power Supply Module The power supply module consists of a main power source, a DC-DC converter, and the battery circuitry including a charger, capacity indicator, protector, and automatic changeover circuit. 2.1.1 The main power source comprises integrated circuit N400 and capacitors C402 through C403

that serve to inhibit ripple voltage. It is accurate in voltage stabilization. The DC-DC converter is a mono-stable transistor self-exciting oscillator comprising transistor V406 and V407, capacitor C404, and transformer T401. Output from the secondary of T401 shall result in a symmetric8 volt power supply after rectifying, filtering, and stabilization. 2.1.2 The charger is a serial voltage stabilizer with a current limiting protector. It charges the battery pack by methods of constant voltage and current limiting. The charging circuitry, consisting of transistor V413 and resistors R413 and R419, is controlled by signal OP. When the instrument is set to CHECK or START, signal OP appears as a high level that leads collector of transistor V413 and output from the charging circuit to be low level, and as a result stops charging the battery. The current limiting circuit consists of transistors V417 and V418, and resistor R413. When the charging current approaches about 300 milli-amperes, voltage across R413, large enough to turn on transistors V417 and V418, leads to reduction of the current flows into the base of transistorv414. Reduction of the output from the charging circuit limits further increment of the charging current. 2.1.3 The charging indicator consists of transistor V419, light emitting diode V422, and integrated circuit N404. While in charging, flowing of current through V419 leads to N404s oscillating and V422s blinking. Increment of voltage at the collector of V419, in compliance with decrement of the charging current, leads N404 to output a high level at increasingly longer time duration until V422 remains steady light. Simply, V422 blinks to indicate charging status. The time duration in which V422 blinks increases with reduction of charging when the charging current is not large enough to keep charging. If switch SA401 is turned on, a 12V voltage is to be applied to the negative end of V422, after voltage dividing by resistor R421 and transistor V423, to turn off it. 2.1.4 When line power is unavailable, pins 11 and 12 of integrated circuit D403 shall emerge a low level in contrast to the high level at pin 10 to changeover of the power supply from AC to battery by ways of turning on transistor V425 and energizing relay KP400. During battery operation, if ECG-11A/B is set to STOP, signal OP appears as a low level in contrast to the high level at pin 9 of D403 to starts the timer consisting of resistor R430, capacitor C401, and a part of D401. Three minutes after the timers starting, V425 is turned off together with dis-energizing of relay KP400 due to a low level at pin 5 of D401 and pin 10 of D403, AND A high level at pin6 of D403. The DC power supply is therefore cut off to protect the battery back from excessive discharging. Effective signal for the timer shall be reset by turning off switch SA401 before turning it on again to guarantee automatic change of power supply from AC to battery. When the battery capacity is below 10.5 volts, V425 is also turned off together with dis-energizing of KP400 due to the high level at pin9 of D401, DC power shall also be cut off to protect the battery back from excessive discharge. 2.1.5 In battery operation, light emitting diodes V432 through V434 indicate battery capacity as follows. Battery Capacity V432 V433 V434 >12.3 volts Light Light Light 11.7~12.3 volts Light Light Dark 10.5~11.7 volts Light Dark Dark <10.5 volts Blinking Dark Dark

Voltage at testing point TP402 shall be 2.45 volts. When the battery capacity is above 12.3 volts, light emitting diodes V432 through V434 are light because of a high level at pins 7 and 8 of N405. When the battery capacity is within the range of 11.7 ~ 12.3 volts, V433 goes out because of a low level at pin 1 of N405. When the battery capacity is within the range of 10.5~11.7 volts, V434 goes out together with V433 because of low level at pins 1 and 7 OF n401. Nevertheless, when the battery capacity is below 10.5 volts, V432 blinks because of a low frequency pulse, due to a high level at pin 14 of D401, from pin 8 of N401. Light emitting diode V435 shall be turned on during battery operation. It is also turned off in AC operation to make sure V432 through V434 be dark. 2.2 The Keyboard Control Module The keyboard control module functions to generate commanding signals necessary for the instrument to operate and indicate instantaneous operation status. It is required to be feasible, quick in acting against stimulus, and correct. The keyboard control module consists of a pulse generator, a paper and stylus heater controller. They are described as follows. 2.2.1 Integrated circuit D213 is a 14-step frequency divider including an oscillator. A 32,768Hz quartz is oscillator is connected in parallel with the inverting terminals, pin 10 and 11, of D213 to output a square wave of 1024/2048/2/4 Hz in frequency, by ways of multi-step frequency division, at pin 5/7/3/2 of D213. 2.2.2 Integrated circuit D207 is a pre-determinable 4-bit up/down counter. It counts up or down depending on a high level or level at pin 10 provided that pin 15 is applied a counting pulse. Pin 1 of D207 is the pre-determinable terminal. It transfers the true value predetermined to pins 4, 12, 13 and 4 to the output terminals of D207. Requirements for output of the counter are described in the following table. TEST 0 0 0 0 I 1 0 0 0 II 0 1 0 0 III 1 1 0 0 AVR 0 0 1 0 AVL 1 0 1 0 AVF 0 1 1 0 V1 V2 0 1 1 1 0 0 1 1 V3 0 0 1 1 V4 V5 V6 1 0 1 0 1 1 1 1 1 1 1 1

Q0 Q1 Q2 Q3

It is required to be predetermined with 0110 and 1010 when lead is changed from V1to AVF and from AVF to V1. When lead is changed from V1 to AVF, integrated circuit D217 develops a high level at pin 14 by decoding the output signal 1001 from the counter to predetermine pin 1 Of D207 with a high level. Input terminals of the counter are predetermined with 0110 that is to be transferred to its output terminals. Integrated circuit D216 decodes the output against 0110 from the counter to light indicator AVF at the moment when D217 develops a low level at pin 14. When lead is changed from AVF to V1, D216 develops a high level at pin 4, by decoding the output signal 0110 from the counter, to predetermine input terminals of the counter with 1010. The latter is to be transferred to its output terminals, by starting the mono-stable oscillating circuit comprising integrated circuits D205Band D206A, capacitor C209, and resistor R211. Pin 1 of D207 is also predetermined with a high level due to the high level from pin 4 of D216. D217 decodes the output signal 1010 from the counter to light indicator V1 by developing a high level at pin 2 at the moment when D216 develops a low level at pin 4. Pressing key UP leads to development of a low

level, which results in applying a counting pulse to pin 15 of the counter after inverting by D206E, by D205 at pin 10. As a result, the counter counts up by 1. Pressing key DOWN leads to development of a high level, which leads to applying a counting pulse to pin 15 of D207, by D205 at pin 9. Respectively, the counter counts down by 1 because of he low level at pin 10 of D207. Resistors R216 and R217, and capacitor C208 are utilized to eliminate quivering due to false key operating. 2.2.3 It is required to generate an INST pulse, in case of lead change, lead abnormal, and the beginning of powering on the instrument, to prevent the stylus heater from deflecting away from the baseline, because bio-electric signal is accompanied with certain polarization voltage of large amplitude. At the beginning of being powered on, the instrument develops a RESET pulse at pin 12 of D206 to predetermine pin 10 of D219 with a high level. Such a level makes it possible to output an INST pulse by ways of the mono-stable oscillator comprising integrated circuit D220D and D221C, resistor R248, CAPACITOR c221, AND TRANSISTOR v234, during lead change. The INST pulse is also generated, as a result of predetermining pin 6 of D219 with a high level by the lead change pulse applied to pin4 of D219. It is to be remained for 0.2 second even after disappearance of lead change pulse to assure the existence of INST pulse while key UP or DOWN is pressed. The INST pulse disappears 0.2 second after operators releasing of the key. The instrument keeps generating INST pulse by developing a high level at pin 5 of D219 to prevent the stylus heater from deflecting large amplitude when lead abnormal happens. 2.2.4 ECG-11A/B features automatic lead change. I t develops a square wave of 2 Hz at pin 3 of integrated circuit D213.This signal is divided by the decimal counter D203 to output at pin 6 another square wave of 0.2Hz in frequency and 1:4 in duty. Integrated circuit D204 develops the INST pulse at pin 9, due to emerging of a high level at pin 6 of D203 and pin 5 of D219, generate the 1mV automatic calibrating signal by multiplying the INST pulse with the square waves of 2Hz and 4Hz. Pulse width of the automatic calibrating signal is widened by the pulse width modulator consisting of integrated circuit D220A, transistor V235, resistor R249, and capacitor C223 to predetermine pin 5 of D215 with a high level. At the meantime, the INST pulse is blocked by driving buffer D208 to guarantee validity of 1mV calibrating signal. D208 also outputs lead code TEST to avoid superimposing cardiac waveform onto the calibrating signal by developing a high level at pin 10 during lead change. Automatic signal of 1mV calibrating pulse is applied to pin 1 of D215, after a delay by R220 and C221, to be used as a signal of automatic lead change simulating the pressing of key UP. When lead is changed from V6 to TEST, D204 outputs a pulse at pin 6 to change, via pin 10 of D219, operation status of the instrument from START to STOP. Accuracy of automatic lead change is guaranteed by the precise frequency generated by the crystal oscillator. Manual operation is allowed to interfere in automatic operation by pressing key UP or DOWN to clear D203 and make lead length remains the same. 2.2.5 The recording system of ECG-11A/B adopts phase locking technology to control paper speed. Integrated circuit D213 outputs square waves of 1024Hz and 2048 Hz at pins 5 and 7 which are transformed into pulse of 102.4Hz or 204.8Hz by multiplying with paper selection signal and frequency dividing through integrated circuit D223B. The pulse of 102.4Hz or 204.8Hz is applied to pin 14 of D221 to be used as reference. Output of phase comparison at pin 13 of D221 is applied to drive the paper motor after filtering power amplification. Speed sensor feeds back related signal to pin 3 of D221 to control output voltage by way of comparing with the reference in frequency or

phase. This is a closed circuit negative feedback control system. It can guarantee paper speed within an accuracy of 1%. 2.2.6 When the instrument is set to STOP, signal OP emerges as a low level to make the stylus heater partly heated to protect itself from unnecessary power dissipation and prolong it lifetime. When the instrument is set to START or CHECK, signal OP emerges as a high level to heat the stylus heater by controlling N307 of the amplification module. 2.3 The Amplification Module The amplification module comprises an input signal processor, angle/position signal detector, signal integrator, push-pull amplifier, and stylus driving circuit. The input signal processor comprises integrated circuit N301B and the related components. It acts as the primary stage of he amplifier to adjust position of stylus baseline and waveform amplitude by adjusting variable resistor RP301 and RP302. Integrated circuit N3030 and N304 form a clamping circuit with resistors R312 and R313, and N301B to avoid applying large signal to the secondary stage of the amplifier to protect the stylus heater and the motor coil. The angle/position signal detector consists of integrated circuit N302 and the position sensor. The position sensor works to detect angle signal of the motor coil before transforming it into electric signal and applying to N302 for amplification. Output from N302 is feedback to N302A as negative feedback input. Variable resistor RP303 is used to adjust angular speed and stylus damp. Variable resistor RP304 is used to adjust angle deflection and clamping amplitude in combination with clamping circuit. Variable resistor RP305 controls zero point. Integrated circuit N301 and N304 carry out integrate amplification of the processed input signal and angle/position signal with resistors R317 and R318. N304 forms a BTL push-pull power amplifier with transistor V308 through V311 to complete power amplifying on signal from the primary stage for driving the stylus motor. The stylus driving circuit consists of N307 and the related components. It acts as a square wave generator. Variable resistor RP306 controls stylus temperature by adjusting heating time depending on the change of the square wave duty. When the instrument is set to START or CHECK, signal OP emerges as a high level to heat the stylus. When it is set to STOP, signal OP emerges as a low level to control square wave duty, and as a result reduce heating time of the stylus. The stylus is therefore set to warm-up. 2. 4 Pre-amplification Module The pre-amplification module consists of buffer amplifiers, differentiate amplifiers, DC amplifiers, photo coupling stage, main amplifiers, and a DC-DC converter. The buffer amplifiers utilize dedicated integrated circuit SDJ-1 that features technique of twice integration. The SDJ-1 matches KT-2 used in ECG-6511 in performance and is interchangeable with it.

Discharging transistors A101 through A110 are connected in parallel with input terminals of the buffer amplifiers. The discharging capacity is about 70 volts. The can inhibit strong pulse voltage during defibrillation. The bipolar diodes connected between input terminal and output terminal of the buffer amplifiers function as the second level protection by guarantee input voltage to be below power supply. The R-C network works to inhibit interference from powerful radio frequency signal. The low resistance signal is applied, after buffering, to the Wilson network comprising integrated resistors of F level precision N116 through n118. The Wilson network is used to eliminate affection on the secondary stage due to mismatch of resistors. Integrated signal is applied together with the balanced chest lead signal to analogous multiplexers D100 through D103 to from standard leads before applying to the differentiate amplifiers. Integrated circuit N103 is the shield driving circuit that amplifies the central potential of the Wilson network to shielding layer of the patient cable after buffering. Part of the common mode interference shall be transformed into difference signal, due to mismat h of distributing capacity c between signal cords and shielding layer of he patient cable, as an interference difficult to reject. Central point potential of the Wilson is just the zero potential of bio-electric signal from human body and common mode voltage point. Isolation of potential in the shielding layer to common mode voltage results in zero potential difference between intra-layer distributing capacitors. Anti-interference of the circuit is therefore enhanced as a result of larger elimination of cap acity affection. Lead change circuit adopts bi-decoder D104 to control multiplexers D100~D103 in sequence. Differentiate amplification stage comprises N105, R123 and R124 to amplify signal by 20 multiples. Variable resistor RP100 is used to calibrate common mode rejection rate (CMRR). Transistor V134 forms the calibrating circuit with resistors R127 through R130 to generate 1mV calibrating voltage. The pulse inhibiting circuit consisting of transistors V131 and V132, capacitors C111 and C112 functions to prevent the powerful pace-making pulse form affecting normal drawing of waveform b blocking the amplifying stage. Capacitor C116, resistors R141and R142 form the DC isolating circuit to isolate polarization voltage and let pass of cardiac signals. Lower limit of the coupling circuit is 0.05Hz. Transistors V137 and V138 form the trace reset circuit to reset baseline in quick action. Integrated circuit N106A is an amplifier of high input impedance with a gain of 20 multiples. Integrated circuit N107 works as a comparator to develop a high level when electrode disconnection occurs which also leads to light of indicator ELECTRODE CHECK and generation of INST pulse to reset baseline. Integrated circuit N106, N108A, and N112, transistors V140 and V141 form the linear photo-coupling circuit to couple the isolated cardiac activity into signal, with the earth as reference, to be used in the secondary stage. N112 is the key component whose specifications match those of PC-02 used inECG-6511 and is interchangeable with it. It is connected in parallel with the closure of the instrument and the isolated earth to meet the requirements of being larger than 1000

mega-ohms in insulating impedance and 2500 volts tolerance for 60 seconds. Only by this, can the patient leakage current in case of malfunction meets the requirements of IEC standard. N106B works as a regulator with open loop application. C118 is used to eliminate oscillation. Transistor V140 drives light emitting diodes of the photo coupler of which photocells at pins 1 and 2 are connected to inverting input terminal of N106B to form closed loop negative feedback. Integrated circuit N116B is capable of regulating in linear operation area of open loop. It is therefore unnecessary to stabilize the +12V power supply for driving. Transistor V139 outputs a 6.2V stabilized voltage to provide the photo coupler a voltage bias through resistorR146. Current bias for driving is within the range of 10~16mA. These factors guarantee dynamic range of this stage be within1V and maximum1.4V. Resistor R150 and transistor V141 form a protecting circuit to monitor driving current via resistor R149 to prevent burning of photo coupler due to excessive current in case of too large input voltage resulted from accident or malfunction. It limits the driving current to be within to be within 50mA by partially turning on V141 and lowering the base potential of transistor V140. In normal status, V141 does not work. Integrated circuit N108A transforms photocell current at pins 5 and 6 into voltage. Variable resistor RP103 is utilized to adjust baseline position by compensating potential bias. The whole photo-coupling stage is controlled by an variable resistor RP102. Secondary stage amplifiers comprises sensitivity selection and filtering. Gain of this stage is 3/6/12 multiples in respect to sensitivity of 0.5/1/2. Sensitivity changeover is controlled by signal from pins 10 and 11 of integrated circuit D105. Pin 9 of D105 works to control selecting of filter HUM. Selecting of filter EMG is controlled by signal EMG which turns on the J type filed effect transistor V146 or turns it off at a frequency of 45Hz. The HUM circuit is a band pass network trapping filter which traps 30dB at 30Hz with bandwidth be larger than 30Hz. It is capable of anti-interference with little distortion. Sockets EXT and CRO are provided for the customer. EXT is used to record external signal via the recording system. CRO is used to output cardiac waveform of the patient for display on oscilloscope. The DC-DC converter provides the isolated circuit with power supply of 8V & 3V. It adopts the 12V voltage from the power supply module to form a push-pull self-exciting oscillator with transistors V161 and V162, and transformer T100 to output the above mentioned power supply after rectifying and isolating the secondary of T100. Theory of operation is described as follows. Capacitor C182 provides the oscillating transistor with current bias for turning on. When V161 is turned on, the current flowing into pins 5 and 6 at primary coil of T100 get increased sharply. Meanwhile, the generation of inductive voltage at pins 1 and 2 of feedback coil that in return speeds up V161s turning on and V162s turning off to from an intensive positive feedback. V161 is thus quickly get saturated. When Ic equals Ib, V161 gets out of saturation. Decrement of Ic leads to generating a negative inductive current that speeds up reduction of Ib. Intensive positive feedback

results in quick turning on of V161 and saturation of V162 and he beginning of he next circle. Capacitor C136 is used to eliminate surging voltage due to turning off and on of the oscillating transistor. Transistor V159 and V160 work to protect BE node of the oscillating transistor. Resistor R181 controls feedback intensity. Capacity C137is a filtering capacitor. DC coupling inductor L103 functions to prevent oscillator from interfering with operation of other parts of the power supply. Waveform at testing point TP101 shall be 16KHz in frequency and 24Vp-p in amplitude. Isolating transformer is an important component concerning safety. It shall endure 1000 mega-ohm of insulating impedance and 2500 volts per minute of voltage tolerance. 2. 5 Mechanical Design Conception ECG is a kind of highly technical bio-electric instrument whose design is of great importance. Following are descriptions of characteristics of appearance. Paper speed control mechanism, and the internal structure of ECG-11A/B. 2.5.1 Design of ECG-11A/B aims at Hi-Tech product of elegance and modernity. Its appearance is principally conceived of cold color with the upper part underlined with cream color, and keyboard with cream dot in contrast to the gray touch panel. Dark green base of ECG-11A/B matches circumstance of hospital. 2.5.2 Paper speed control mechanism is as important as electric parts. It is required to be accurate in speed stabilization, quick in starting, and feasible in operating. To meet requirements of speed stabilization, it adopts phase locking technique whose key part is a phase comparator which compares reference frequency with speed feedback signal before output a square wave to drive the motor through a filter and a power amplifier. The comparator outputs a high level to speed up the motor by raising its operating voltage when its speed is below normal value. When speed of the motor is above normal value, the comparator outputs a low level to lower it speed by reducing the operating voltage. The reference frequency, of precision due to utilization of crystal oscillator, and the indirect method of speed measurement guarantee paper speed and long term operation of the mechanism. 2.5.3 ECG-11A/B is of simple operation and powerful in anti-interference, because it takes into account of internal interference while designing its internal parts. 3 Adjustment and Maintenance Operators of ECG-11A/B are required to read through operation manual before operating the unit. Familiarity with correct adjustment of linearity, frequency response and other specifications, is the best way to acquire consistent linearity and trace of little distortion, as well to lay the foundation of correct diagnosis of heart problems. Following are descriptions of regular adjustment and maintenance for ECG-11A/B. Users are required to contact manufacturer or professional personnel in the case of troubleshooting malfunctions. 3.1 ECG-11A/B requires use of thermal recording papers. Stylus temperature and damp had been

adjusted at factory on the basis of recording paper of medium thermal susceptibility. It is therefore important to readjust damp and stylus temperature, whenever recording paper is changed, to optimize the trace. 3.1.1 Adjustment of stylus temperature may be carried out according to the trace. Adjust stylus temperature as follows. a. Turn off the filters. b. Set the instrument to START. c. Take the upper cover of the recorder before fetching the little screw and adjusting temperature controller in clockwise or counterclockwise depending on too lower or too high temperature. d. Evaluate the optimum stylus temperature by the trace of the trace of which the heaviness shall be within the range of 0.3~0.5mm. 3.1.2 Correct damp is vital to record waveforms. It shall be adjusted according to recording papers. Adjustment of damp is as follows. a. Turn off the filters. b. Set sensitivity of the instrument to 1. c. Set the instrument to standard paper speed and lead position TEST. d. Press key 1mV to trace 1mV calibrating signal which is required to be as shown in the following figure. e. Adjust the damp controller in clockwise or counterclockwise depending on too small or too large damp. 3.1.3 The instrument adopts precise voltage stabilizer to generate 1mV signal for calibrating. Amplitude of the 1mV signal shall not change with line power supply or battery voltage. It has been adjusted at factory according to standard sensitivity to10mm/mV2%. It is required to adjust the gain controller in clockwise or counterclockwise depending on too small or too large 1mV signal. It is unnecessary to carry out the aforementioned adjustment provided that the instrument is in long term steady operation. Instead, the operator is only required to make proper checks. 3.2 Operating Instructions 3.2.1 Power on the instrument before setting lead to TEST and checking 1mV signal by way of key 1mV under conditions of standard sensitivity, standard paper speed, non-filter operation in addition to locating stylus at the middle of the recording paper. Adjust 1mV signal according to the previously described procedures when it does not meet requirements. 3.2.2 Apply ECG jelly to surface of patient body and lead connectors before attaching limb electrodes and chest electrodes, according to definition, to the patient. Lead connectors shall be in good continuity with plug of patient cable. The patient cable shall be so placed that it is away from power cable to avoid doing harm on patient or incurring interference. Lead connection shall also be checked by ways of indicator electrode abnormal and pressing lead selector in turn. 3.2.3 Set the instrument to check and lead I, and make sure styluss deflecting is not accompanied with interference. Filter must be selected if the styluss deflecting is accompanied with obvious interference. Key reset must be pressed to start from the beginning after the patients

getting calmed provided that the stylus large amplitude from the baseline. Physicians and operators shall be aware that filter operation is to result in distortion of 1mV signal which manifests itself as the damps difference from the calibrated. Simply, it is unnecessary to carry out another calibration after filter selecting. 3.2.4 Recording must be started only after checking normal deflecting of the stylus. ECG-11A/B features automatic and manual lead change. The tow modes is able to changeover each other at any lead. Manual operation is allowed to interfere in automatic operation to set desired lead position. 3.3 Cautions 3.3.1 Environment condition plays an important role in the instruments normal operation. Environment conditions for ECG-11A/B are described as follows. a. Temperature: 5 ~40 b. Relative Humidity: 80%

c. Away from X-ray equipment, elevator, power distributor. 3.3.2 In clinical application, it is important to keep the patient insulating from the earth by preventing them from in touch with metal parts of the metallic examination table or by providing insulation between the wooden examination table and the earth. 3.3.3 The instrument must be well grounding cable so as to reduce interference and to guarantee the operators safety. 3.3.4 Power supply for the instrument shall be of 220V2% in amplitude and 50Hz 2% in frequency. If there is intensive and frequent surge, it is required to provide the instrument with power supply by voltage stabilizer. 3.3.5 The instrument is to work continuously less than 4 hours. Excessively continuous working hour shall result in quantitative heating and may lead to malfunction due to poor ventilation. 3.4 Periodic Maintenance 3.4.1 ECG-11A/B is characterized by ac power and battery power supply. It is equipped with a built-in battery pack to provide uninterrupted power supply for continuous operation by automatic changeover from ac to battery when ac power is unavailable. It also provides circuits for battery charging, excessive discharge protection. The battery pack shall work continuously for two hours provided that it is fully charged. Its lifetime is up to two years if it is maintained correctly as follows: a. Less than 2 hours of continuous operation as well as stop operation in case of capacity indicators blinking. b. Immediate recharging posterior to each operation and setting of the power switch to charging position when the instrument is not in operation. Indicators keep lighting to indicate full

charge. c. Battery pack shall be stored in a dry environment and be charged every 1 month even when it is not to be used for a long time. 3.4.2 Maintenance of the stylus is vital to clarity of the instruments trace. It shall be maintained as follows: a. Rubbing against the roller of the cargo with stylus is not allowed if recording paper has not been loaded. b. Stylus temperature shall be kept properly to prolong its lifetime. Replace stylus by disconnecting stylus connector before removing the existing one and mounting the new stylus. It is required to adjust damp and temperature immediately after replacement of the stylus. 3.4.3 Twisting of the patient cable in operation is not allowed, for it will cause disconnection of its internal leads. a. Disconnect the lead connectors, after operation, by taking hold of the connector, instead of pulling the lead cords, to avoid cause of disconnection on internal leads of the patient cable. b. Wipe out ECG jelly applied to the patient cable, after operation, to avoid affecting normal tracing due to reduced insulation. 4 Troubleshooting ECG is a king of precise electronic instrument. Specifications and performance of its circuitry and mechanical parts are specifically defined. It is important to make the repaired instrument meet the requirements instead of simply change certain parts. All reparation shall be based on theory and scientific analysis. Otherwise, it is possible to worsen the instruments conditions. The person responsible for field service is required to be familiar to structure and operation theory of modules, specifications and functions of components, as well as performance of the instrument as a whole. They shall pay attention to following descriptions. a. Acquaint oneself with malfunction manifests and the process of its occurrence. This is the base for analyzing and finding out cause of the malfunction. b. Visual checks without power on the instrument. c. Blind adjustment of variable resistors & capacitors concerning static operation point, dynamic equilibrium, damp, and reference voltage may lead to performance change of the instruments circuitry. Generally, a voltmeter or oscilloscope is used to measure parameters of components to ease analysis and judgment on malfunction by comparing actual value with the requirements. Encountering malfunction concerning large scope, service engineer may cut apart the circuitry at the middle of the scope to narrow possible malfunction scope. This method is classified into circuit opening and circuit shorting. Following are descriptions of troubleshooting for the instrument. 4.1 Pre-amplification Module 4.1.1 Abnormal Floating Power Supply Possible cause and solution to abnormal floating power supply are described as follows. a. The push-pull oscillator does not work. This oscillator works by ways of transistors v161 and





v162s alternative turning on/off and the current bias provided by resistor R181. It is therefore necessary to check operation parameters of v162, v162, r181 as well as inductive L103. The isolating transformer malfunctions. Malfunction of the isolating transformer is generally due to damage or shorting of the coils at its primary and the secondary. Voltage at pins7, 6, 5, and 4 of its primary shall be 0 volt. Pins 2 and 11 shall emerge power supply with the earth as reference. Voltage at pins of its secondary are as follows. Vp14=Vp13=-3.2V; Vp12=Vp11=7.5V; Vp10=Vp9=0V Rectifying output is abnormal. It is the diodes v149 through v158 that are responsible for rectifying. In case of this event, it is necessary to check performance of v149 through v158 and capacitors c134 and c131. Zero input to the linear stabilizers. Normal conditions of the linear stabilizes shall be as voltages of 8V0.5 at pin 1 of n111 and +12V0.2 at pin 1 of n110. It is always damage of inductive L101 and L102 and capacitors c133 and c130 that cause zero input to stabilizers (78L08) n110 and n111. Abnormal output from the linear stabilizers. Possible cause may be shorting of their output terminals or damage of itself.

4.1.2 Abnormal Power Supply Power supply is provided by power supply module. This kind of trouble is probably is probably caused by shorting of multiplexer d105 (4053) to the power supply due to internal damage. When the positive power supply is not available, attention shall be paid to pin 5 of connector xs103 (shorting to the earth) and pins 6 and 16 of d105 (shorting to each other). When the negative power supply is not available, attention shall be paid to pin 6 of connector xs103 (shorting to the earth) and pin 7 (shorting) to pin 8 or 6) of d105. 4.1.3 Uncontrolled Baseline Baseline is normally controlled by adjustment of compensating potential. Photo-coupler gd2203 couples light intensity from the light emitting diode into linear light current by way of regulating. Amplifier n108a transforms the liner light current into voltage signal. Variable resistor is used for potential compensating. Uncontrolled baseline is principally resulted from abnormal voltage at pin 8 of n108 and the positive end of transistor v141 which shall be 6.2 volts. 4.1.4 Abnormal Calibrating Signal a. Calibrating signal unavailable. When calibrating, keyboard control module generate 1mV calibrating signal which leads to emerging by photo-coupler n114 high level at pin 3 and low level at pin 10. Transistor v134 is turned off when p10 emerges high level. V134 is therefore turned on whenever a calibrating pulse is generated. V134s turn on leads to stabilized reference voltage at the stabilizing diode v133 which is transformed into 1mV calibrating signal, to be used as amplitude calibrating signal for the instrument, by way of voltage dividing. Amplitude of the 1mV signal is amplified into 1 volt via 20 multiples at the first stage, 10 multiples at the second stage, and 6 multiples at the third stage. It is thus necessary to check performance of the aforementioned components (pins 3 and 10 of n114, v134, v133) as well as amplifiers n105 and n106, when calibrating signal is not available. b. Abnormal calibrating signal. Encountering this trouble, attention shall paid to multiples of each

amplification stage as mentioned in a before checking parameters of variable resistors pr101 (25 kilo-ohm) and rp102 (25 kilo-ohm), and resistor r151 (10 kilo-ohm). 4.1.5 Abnormal INST Signal Transistors v137 and v138 are required to be of little current leakage and consistence to each other in performance. 4.1.6 Abnormal EMG Filter Selecting of EMG filter is controlled by signal from pin 11 of connector xs101 by way of J-type field effect transistor v146s turning on /off. When EMG signal is available, transistors v147 and v148 are turned on which in return turns on v146. It is always damage on v146 or 148 that results in abnormal EMG signal. 4.1.7 Abnormal HUM Signal What concern filtering depth are resolution of resistors r165 and r166, capacitors c123 and c124. 4.1.8 Excessively Large Baseline Drift Photo-coupler gd2203s operation in saturated area leads to large current in light emitting diode (excessively large Ic of v140). This current makes voltage drop across resistor r149 large enough to turn on v141. Voltage at pin 3 of gd2203 shall be larger than 600mV when the instrument behaves excessively large baseline drift. 4.2 Keyboard Control Module Keyboard control module is required to be feasible in operation, quick in acting against stimulus, and accurate in command. It consists of a pulse generator, lead selector, inst pulse generator, 1mV calibrating signal generator, paper speed and stylus heater controllers. Keyboard control module shall generate an inst pulse, in case of lead change, lead abnormal, and the beginning of power on the instrument, to prevent stylus heater from deflecting away from the baseline, because bioelectric signal is accompanied with polarization voltage of large amplitude. At the beginning of power on the instrument, it develops a reset pulse at pin 12 of d206 to predetermine pin 10 integrated-circuit d219 with high level which makes it output an inst pulse by way of the mono-stable oscillator comprising integrated-circuits d220d, d221c, resistor r248, capacitor c221, and transistor v234. During lead change, the inst pulse applied to pin 4 of d219, and remained for 0.2 second even after disappearance of lead change pulse to ensure existence of inst pulse during pressing of key up or down. The inst pulse disappears 0.2 second after operators releasing of the key. The instrument keeps generating inst pulse by developing high level at pin 5 of d219 to prevent stylus heater from deflecting large amplitude when lead abnormal occurs. Following are troubleshooting for this module. 4.2.1 Key Malfunction

Key malfunction lies in unavailable output change from Schmitt triggers and unavailable status change of output from triggers or registers. The former is always resulted from circuit opening or shorting, and requires to check performance of the Schmitt triggers and the 0.1 uf-capacitor connected in parallel to each key. The latter is cause by the following four factors: a. Unavailable status change of input to triggers or registers. b. Resetting terminals of triggers or registers are forcibly reset. c. Shorting at output terminals of triggers or registers. d. Malfunction of the triggers or registers. 4.2.2 Light Emitting Diode Malfunction Light emitting diode malfunction lies in incapability of indicator to light and incapability of indicators to light. The former is result from wrong level at output terminals of inverting buffers or unqualified performance of light emitting diodes. 4.2.3 Abnormal Paper Speed Abnormal paper speed lies in as follows: a. The paper motor does not work when the instrument is set to start. b. Uncontrolled paper speed.