EDAN SE-3 Service Manual.pdf

EDAN INSTRUMENTS, INC.

SE-3 3Manual Ver: V1.3 Release Date: Aug. 2008 Part Number: MS1R-20094-V1.3

Copyright © Copyright EDAN INSTRUMENTS, INC. 2008. All rights reserved.

Statement Edan Instruments, Inc. (hereinafter called EDAN) makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. EDAN assumes no responsibility for any error that may appear in this document, or for incidental or consequential damage in connection with the furnishing, performance or use of this material. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of EDAN. All information contained in this publication is believed to be correct. EDAN shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this material. This publication may refer to information and protected by copyrights or patents and does not convey any license under the patent rights of this company, nor the rights of others. This company does not assume any liability arising out of any infringements of patents or other rights of third parties. The information contained in this document is subject to change without notice.

Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. NOTE: This device is not intended for home use. WARNING

: This device is not intended for treatment.

Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable. -I-

Using This Label Guide This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE: A NOTE provides useful information regarding a function or a procedure.

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Table of Contents Chapter 1 General ...................................................................................................................... 1 1.1 Function Features ............................................................................................................ 1 1.2 Environment Requirement .............................................................................................. 2 1.3 Power Supply Requirement............................................................................................. 2 Chapter 2 Appearance Views .................................................................................................... 3 2.1 Top Panel......................................................................................................................... 3 2.2 Patient Cable Socket and Signal Interface ...................................................................... 3 2.3 Mains Connection and Switch......................................................................................... 5 2.4 Bottom Panel ................................................................................................................... 5 Chapter 3 Principle .................................................................................................................... 6 3.1 Abstract of theory of ECG operation............................................................................... 6 3.2 Composition of ECG....................................................................................................... 6 3.3 Lead................................................................................................................................. 7 3.4 Hardware Design Principle Description.......................................................................... 9 3.4.1 ECG Board description ....................................................................................... 10 3.4.2 Main control part description .............................................................................. 11 3.4.3 Power control part description ............................................................................ 12 Chapter 4 Tests ......................................................................................................................... 13 4.1 System Tests .................................................................................................................. 13 4.2 Application System Tests .............................................................................................. 13 4.3 Safety Tests.................................................................................................................... 15 Chapter 5 Electrocardiograph Servicing ............................................................................... 16 5.1 Disassembly Steps......................................................................................................... 16 5.2 Internal Boards and Interfaces....................................................................................... 19 5.3 Troubleshooting............................................................................................................. 23 Chapter 6 Electrocardiograph Installation............................................................................ 27 -III-

6.1 Power and Earthing ....................................................................................................... 27 6.2 Loading/Replacing Record Paper.................................................................................. 28 6.3 Patient Cable Connection.............................................................................................. 29 6.4 Electrodes Connections ................................................................................................. 30 6.5 Inspection before Power On.......................................................................................... 32 Chapter 7 Cleaning .................................................................................................................. 34 7.1 Clean.............................................................................................................................. 34 7.1.1 Clean the Main Unit and Patient Cable............................................................... 34 7.1.2 Clean the Electrodes............................................................................................ 34 7.1.3 Clean the Print Head ........................................................................................... 34 7.2 Disinfection ................................................................................................................... 35 Chapter 8 Maintenance ........................................................................................................... 36 8.1 Recharge and Replacement of Battery .......................................................................... 36 8.2 Record Paper .......................................................................................................... 37 8.3 Maintenance of Main Unit, Patient Cable & Electrodes ........................................ 37 Chapter 9 Technical Specifications......................................................................................... 39

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SE-3 3-Channel Electrocardiograph Service Manual

Chapter 1 General SE-3 is 3-channel electrocardiographs with 12 leads gathered simultaneously, visual display of operation menu, ECG parameters as well as electrocardiogram. 3-channel ECG can be viewed on the LCD (liquid crystal display) screen of SE-3 simultaneously. And it can be recorded by high-quality thermal recorder. Manual, automatic, rhythm recording mode and USB print mode can be chosen conveniently. Either mains supply or built-in rechargeable Lithium battery can be used as power. With a high resolution thermal printer, 32-bit processor and huge capacity memorizer, SE-3 has advanced performance and high reliability. And the compact size makes it suitable for clinic, hospital and ambulance use. Configurations: Main unit and accessories (power cord, earth wire, patient cable, electrodes and thermal recording paper) Note: It is not designed for internal use and direct cardiac application.

1.1 Function Features ♦

Low weight and compact size

♦

Touch key for easy operation

♦

High resolution thermal recorder, recording frequency response ≤150Hz

♦

12-lead gathered and amplified simultaneously, 3-channel built-in recorder

♦

Automatic mode, manual mode, rhythm mode and USB print mode optional

♦

Measurement function and interpretation function optional

♦

LOGIN/PRINT/GENERAL/SYSTEM menu for parameters setting (Only for the device with 320×240 dot single color LCD Screen)

♦

Built-in rechargeable Li battery with high capacity

♦

Hint information for lead off, lack of paper and low battery capacity etc.

♦

Automatic adjustment of baseline for optimal recording

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♦

Standard input/output interface and RS232 communication interface for linking to special network and setting up ECG database

1.2 Environment Requirement The environment requirements are listed in the following table. Transport & Storage

Working

Temperature:

-20℃~+55℃

5℃~40℃

Relative Humidity: Atmospheric Pressure:

25%~93% (Non-Condensing)

25%~80% (Non-Condensing)

700hPa~1060hPa

860hPa~1060hPa

1.3 Power Supply Requirement Power Supply 1) Mains Supply: Rated input voltage:

100V~115V/220V~240V

Rated frequency:

50Hz/60Hz

Rated input power:

35VA

2) Built-in Rechargeable Lithium Battery Pack: Rated voltage:

14.8V

3) Power Consumption:

35VA

4) Fuse Specification: T200mA 250V Ø5×20 (for 220V~240V) T400mA 250V Ø5×20 (for 100V~115V)

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Chapter 2 Appearance Views 2.1 Top Panel Smart ECG SE-3 LCD Screen Record Paper USB Interface

Recorder

External

Control Panel

Input/Output

Socket RS232 Socket Patient Cable Socket Figure 2-1 Main Unit (320×240 dot single color LCD Screen)

2.2 Patient Cable Socket and Signal Interface There are sockets including the patient cable socket, RS232 socket, external input/output socket and USB interface at the right side of the main unit as Figure 2-1 shows. 1) Patient Cable Socket

: Applied part of type CF with defibrillator proof : Attention – see accompanying document

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Definition of corresponding pins: Pin

Signal

Pin

Signal

Pin

Signal

1

C2 (input)

6

SH

11

F (input)

2

C3 (input)

7

NC

12

NC

3

C4 (input)

8

NC

13

C1(input)

4

C5 (input)

9

R (input)

14

NC

5

C6 (input)

10

L (input)

15

N or RF (input)

2) RS232 Socket WARNING

:

RS232 interface is 1500V AC isolated intensity and the maximum voltage applied should not exceed +15V DC.


Signal

Pin

Signal

Pin

Signal

1

NC

4

NC

7

NC

2

RxD (input)

5

GND

8

NC

3

TxD (output)

6

NC

9

NC

3) External Input/Output Socket


Signal

Pin

1

GND

4

GND

2

GND

5

ECG Signal (input)

3

GND

6

ECG Signal (output)

-4-

Signal


4) USB Interface


Signal

Pin

1

VBUS

3

D+

2

D-

4

GND

WARNING

Signal

: Only the USB equipments recommended by EDAN can be connected to the USB interface.

2.3 Mains Connection and Switch

Potential equalization terminal Mains Power Switch Mains Supply Socket

2.4 Bottom Panel Mains Supply Shift Switch

Battery Compartment

Fuse

Fuse Label

Label

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Chapter 3 Principle 3.1 Abstract of theory of ECG operation The heart is a power organ of the body blood circulation. Before the systole or diastole, a cardiac impulse happens in the heart muscle, and a faint bioelectric current signal is thus generated. The bioelectric current signal is transmitted through the whole body, and the electric potential difference is generated on the different skin surfaces because of the different distances from the heart. The cardiogram is a record of the amplification of the electric potential distribution on the body skin surface. The electric potential difference is sampled by the electrodes, and is amplified and processed by the electrocardiograph, and at last it is recorded on the paper. From it the doctor can detect if the heart has a disease. The Electrocardiograph is just a kind of medical electrical equipment intended for producing cardiograms for diagnostic purposes with 10 associated electrodes at certain specific locations on the body. They only record the heart's electrical activity. They do not produce any electricity of their own. The test does not hurt and has no known side effects. It does not require any preparation (except for possibly shaving chest hair to get a better recording). The recording itself takes only a few seconds. There has been more than one hundred years since the electrocardiograph was applied in clinical diagnosis. It is an important measure in clinical diagnosis of heart-disease. This instrument has been equipped in almost every hospital and clinic.

3.2 Composition of ECG The standard 12-lead electrocardiogram is a representation of the heart's electrical activity recorded from electrodes on the body surface. The normal ECG wave consists of P wave, QRS complex, ST segment, T wave and U wave. In the following figure, the x-axis is time and y-axis is voltage. When the recording speed is 25mm/s and the sensitivity is 10mm/mV, one little grid in x-axis represents 0.04 second, and one little grid in y-axis represents 0.1mV. This diagram illustrates ECG waves and intervals as well as standard time and voltage measures on the ECG paper.

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Figure 3-1 Composition of ECG

P wave: the sequential activation (depolarization) of the right and left atria QRS complex: right and left ventricular depolarization (normally the ventricles are activated simultaneously) ST-T wave: ventricular repolarization U wave: origin for this wave is not clear - but probably represents "after-depolarizations" in the ventricles. PR interval: time interval from onset of atria depolarization (P wave) to onset of ventricular depolarization (QRS complex) QRS duration: duration of ventricular muscle depolarization QT interval: duration of ventricular depolarization and repolarization RR interval: duration of ventricular cardiac cycle (an indicator of ventricular rate) PP interval: duration of atria cycle (an indicator or atria rate)

3.3 Lead It is important to remember that the 12-lead ECG provides spatial information about the heart's electrical activity in 3 approximately orthogonal directions: Right

Left

Superior

Inferior

Anterior

Posterior -7-


Each of the 12 leads represents a particular orientation in space, as indicated below (RA = right arm; LA = left arm, LL = left leg): Bipolar limb leads (frontal plane): Lead I: RA (-) to LA (+) (Right Left, or lateral) Lead II: RA (-) to LL (+) (Superior Inferior) Lead III: LA (-) to LL (+) (Superior Inferior) Augmented unipolar limb leads (frontal plane): Lead aVR: RA (+) to [LA & LL] (-) (Rightward) Lead aVL: LA (+) to [RA & LL] (-) (Leftward) Lead aVF: LL (+) to [RA & LA] (-) (Inferior) Unipolar (+) chest leads (horizontal plane): Leads V1, V2, V3: (Posterior Anterior) Leads V4, V5, V6:(Right Left, or lateral)

Figure 3-2 Standard limb leads

RA: right arm LA: Left arm LL: left Leg V1: right 4th intercostal space V2: left 4th intercostal space V3: halfway between V2 and V4 V4: left 5th intercostal space, mid-clavicular line -8-


V5: horizontal to V4, anterior axillary line V6: horizontal to V5, mid-axillary line

Figure3-3 Chest electrode of the standard limb leads

3.4 Hardware Design Principle Description The SE-3 electrocardiograph consists of the following functional blocks: 1)

Keyboard panel for user input/output;

2)

Front_end module including signal acquisition, digital filter and the amplifier;

3)

ARM9 and peripheral module;

4)

Thermal Printer module;

5)

LCD display module;

6)

Power supply module.

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Figure 3-4 SE-3 machine block diagram

3.4.1 ECG Board description

Figure3-5 ECG Board circuit block diagram -10-


This module is a 12-channel ECG signal sampling and processing module. It can realize the amplification and pre-processing of patient ECG signal in every channel, and the detection of lead situations, as well as sending data to ARM9 MCU. This module is connected to ARM9MCU through UART port. The standard 12-lead electrocardiograph has 10 lead cables, including 9 lead signal input and 1 Right Foot electrode as the float ground. The ECG signals pass through the defibrillator protection circuit, buffering circuit (U1~U3), and enter the difference amplifier circuit. And then they continue to pass through the pacemaker pulse restraining, high-pass filter, low-pass filter, channel switch, second level amplification, and are sent to the A/D sampling port of MSP430F147. Because the ECG system must meet the safety requirement of the photo-electricity isolation, the serial signals will be sent to the photo-electricity component.

3.4.2 Main control part description The main control part includes ARM9 Board and Interface Circuit Board. ARM9 Board consists of MCU S3C2410, SDRAM, NAND FLASH, NOR FLASH, LAN controller, and CPLD etc. The main frequency is 203MHz. The interface Circuit Board consists of RS232 interface, LAN interface, USB interface, printer interface, LCD interface, and keyboard interface etc. It also provides power supply to the device.

Figure 3-6 ARM9 Board circuit block diagram

The system uses ARM9 (S3C2410) (U1) as the control MCU, and the peripheral equipments are connected to the MCU ports. The MCU controls the peripheral equipments by several kinds of methods. The system expands 64M external SDRAM (U6, U7), 64M FLASH (U2), LAN -11-


Controller (U9) and CPLD (U8). The Interface Circuit Board integrates all sockets for USB, Ethernet, Input/output, RS232 and thermal printer. And the main control circuits include Paper Detection circuit (U18), Motor Driving circuit (U16, U17), Thermal Recording circuit (U14, U15) and Heat Time Control circuit (U19). And external analog input is connected to MCU by U21. The thermal recorder has step motor and transmission frame of its own. And the paper detection is carried out depending on a photoelectric diode. The keyboard uses filmy keys, and the keyboard control component uses 3*4 matrixes, 12 keys in total. SE-3 (Configuration A) uses 192*64 LCD screen that adopts 8 bit bus interface. The mainboard of SE-3 uses 8 GPIO to simulate 8 bit buses to control the reading and writing of LCD screen. SE-3 (Configuration B) uses 320*240 LCD screen that adopts standard FSTN interface. Because ARM9 has the FSTN interface of its own, it can be drived directly after connected.

3.4.3 Power control part description 220VAC voltage passes linear transformer and is transformed into 20VAC voltage. One part is provided to charge the battery, and another part passes DC/DC to provide +8V for thermal prinhead, +5V for electric machine, +5V for core board and +5V for ECG board.

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Chapter 4 Tests 4.1 System Tests 1. Unit appearance and assembly examinations 1) Clean appearance, firm assembly, no remainder in the unit when shaking it. 2) Keys feel well when pressing. 3) Labels are full and correct. 4) Standard configurations are full; Sockets are installed firmly. 5) Vibration test should be done before doing the following tests. 2. Switch on After turned on, the electrocardiograph runs well and LCD screen displays well.

4.2 Application System Tests 1. Equipment Requirement Equipment

Model

ECG emulator

FLUKE MPS450

2. LCD screen tests Observe if some characters are missing, or there are bright spots and dark shadows on the LCD screen. Observe if the waveforms, fonts and symbols displayed on the LCD screen are normal.

3. Lead off tests Under AUTO mode, when pull out and insert the lead cables according to the sequence of the lead cables inserted into the ECG emulator, the electrocardiograph will accurately identify the disconnection and connection of the corresponding lead cables. When pull out several lead cables simultaneously, the electrocardiograph will give the hint information of lead off circularly. 4. Keys tests Press every key on the keyboard to test if they work as the descriptions in the user manual. 5. Menu setup and store capability tests Enter the More Setup interface of System Setup window, and set the Default as Yes, and then the -13-


system will be shifted to the main interface automatically. And then enter the corresponding interfaces of the System Setup window to set the current time and change some menu options and exit. Turn off the electrocardiograph, and turn on it five seconds later. When the electrocardiograph is ready for examination and recording, observe if the time displayed on the LCD screen is the current time. And enter the corresponding interfaces of the System Setup window to see if these menus keep the changed options. Then restore these menus to the default values and turn off the electrocardiograph. Five seconds later, turn on the electrocardiograph again. When the electrocardiograph is ready for examination and recording, observe if the menus are still the default options. 6. Heart Rate display tests Set the heart rate output from the ECG emulator as different values, and the error of Heart Rate values displayed on the LCD screen of electrocardiograph should be within ±1bpm. When the heart rate output from the ECG emulator is 240bpm, the electrocardiograph will give the hint information of Heart Rate exceeding the limit and make an alarm sound. 7. Recording tests 1) Set the following values: The heart rate output of ECG emulator is 80bpm, the work mode of electrocardiograph is auto, the speed is 25mm/s, the AC Filter is off, the Lowpass Filter is 150Hz and all the options in the Record Setting menu are on. Install the recording paper and press PRINT/STOP key to begin to record. Examine whether the recording content are integrated and consistent with the information displayed on the LCD screen. 2) Make the ECG detector output the sine wave with 2mV and 10Hz. Press PRINT/STOP key to begin to record. Examine whether the recording content are integrated and consistent with the information displayed on the LCD screen. The amplitude of ECG waveform of Lead I should not be less than 25mm. 3) The ECG record includes: Date and time, ID, Name, Sex, Age, Sensitivity, Paper speed, filter, Lead, 1mV calibration mark, ECG waveform, Heart Rate etc. Meanwhile, before recording ECG wave, 1mV Calibration mark and lead names will be recorded. Recorded characters and waveforms are clear. 4) Open the casing of recorder and remove paper, the hint information of “Paper?” should be displayed. Install the paper again and close the casing of recorder, the hint information of “Paper?” should disappear.

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4.3 Safety Tests 1) Test the protection earth resistance according to IEC/EN 60601-1: Limit 0.1 ohm. 2) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 uA, SFC 1000uA. 3) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10 uA (CF). 4) Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC/EN 60601-1: Limit: 50uA (CF).

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Chapter 5 Electrocardiograph Servicing 5.1 Disassembly Steps 1. View of whole machine

2. Disassembly steps of the whole machine and recorder casing Remove the crosshead screws ① (M3×10) in the four corners of the bottom of electrocardiograph. Open the upper unit ③ and remove the cables between the upper and lower unit, and then separate the upper unit from the lower. In the following pictures, ② is the lower unit, and ④ is the recorder casing.

3. Disassembly steps of the upper unit (Configuration A--192×64 dot single color LCD screen) The upper unit of the electrocardiograph (192×64 dot single color LCD screen) includes the -16-


lower casing of the displaying box, filmy switch panel, LCD screen, rotation base etc. The disassembly steps: Remove the cables between LCD screen ⑩, filmy switch panel ⑨ and transfer board ②.→Remove the five crosshead panhead screws ① (M3×6), and dismantle the transfer board ②→Remove the four crosshead panhead screws ⑤ (M3×8), and dismantle the upper casing of the displaying box to show the LCD screen ⑩ and rotation base ④ fixed on the lower casing of the displaying box. →Remove the screws used to fix the LCD screen and dismantle the LCD screen. →Remove the two crosshead sunk screws ⑧ (M3×20) to dismantle the lower casing of the displaying box ⑥→Remove the four crosshead sunk screws ⑦ (M3×6) to dismantle the rotation base ④. The label (11) and filmy switch panel ⑨ are sticked to the upper unit ③, and can be torn off. Note: The LCD screen should be protected from being damaged when disassembling it.

4. Disassembly steps of the upper unit (Configuration B--320×240 dot single color LCD screen) The difference between disassembling Configuration A and B is that the LCD screen of Configuration B is embedded in the upper casing of the displaying box, while the LCD screen of Configuration A is fixed in the lower casing of the displaying box by screws. The following picture shows: ① crosshead panhead screws M3×6, ② transfer board, ③ the upper unit, ④ rotation base, ⑤ crosshead panhead screws M3×8, ⑥ the lower casing of the displaying box, ⑦crosshead sunk screws M3×6, ⑧crosshead sunk screws M3×20, ⑨ LCD screen, ⑩ filmy switch panel, (11) the upper casing of the displaying box, (12) label, (13) protection screen.

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5. The picture of lower unit

6. Disassembly steps of the lower unit Remove the cables between two parts before disassembly. Remove the transfer board of power supply ⑨ which is embedded in the groove of the lower unit→ Remove screws to dismantle the interface board ⑧ and ECG board ⑦→Remove crosshead panhead screws ⑥ (M3×8) and dismantle the transformer ⑤→Remove the two crosshead panhead screws ④ (M2×6) and dismantle the print-head ③→Remove the four crosshead sunk screws ② (M3×6) and dismantle the print bracket ①.

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5.2 Internal Boards and Interfaces 1. ECG board—receiving and processing ECG signals

①

① P2--socket connected to the interface board

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Pin 1

Description Digital signal (output) RxD (input)

3

Pin

Description

2

GND

4

TxD (output)

+5V

5

2. Interface board—integrating power supplies and input/output interfaces

①

②

③

④

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① CON11-- Socket connected to ECG board. Please refer to P2 socket of ECG board for pin information. ② CON12-- Interface connected to recorder. Pin

Description

1

Draw to GND

2, 15

+5V

3

Paper Detection

16

Temperature Detection

4, 5, 24

NC

6, 7, 25, 26

+8V

8

Data Output

9

Clock Output

10, 11, 19, 20, 21, 22

GND

12, 13, 14, 17, 18, 23

Control Signal Input (valid in low electrical level)

27, 28, 29, 30

Drive Signal of Electric Motor

③ CON8—Interface of LCD (Configuration B) Pin

Description

1, 2, 3, 4

Data Signal of LCD Screen

5

LCD Displays control signal -21-


H: DISPLAY ON 6, 7, 8, 9, 21

Control Signal of LCD Screen

10, 40

+3V

11, 21, 22, 27, 34, 35

GND

12, 15~19, 23, 24

NC

13

Analog Signal Input

14

Restoration Signal

25, 26, 28~33

Control Signal of Filmy Switch Panel

36

Mains Supply Indicator Signals (Analog Signal)

37, 39

Battery Recharging Indicator Signals (Analog Signal)

38

Battery Indicator Signals (Analog Signal)

④ CON7—Interface of LCD (Configuration A) Pin

Description

1, 2, 23, 24

NC

3, 22, 27, 34, 35

GND

4

+5V

5, 6

Analog Signal Input

7, 8, 11, 12, 21

Control Signal of LCD Screen

9

Restoration Signal

10, 13~20

Data Signal of LCD Screen

25, 26, 28~33

Control Signal of Filmy Switch Panel

36

Mains Supply Indicator Signals (Analog Signal)

37, 39

Battery Recharging Indicator Signals (Analog Signal)

38

Battery Indicator Signals (Analog Signal)

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3. ARM9 board—LCD display control, data process, ECG analysis

5.3 Troubleshooting The electrocardiograph is a complicated electrical device and it is difficult for even an experienced person to repair the internal hardware failure. The manufacture does not recommend the user to repair it. Always call the representative of the manufacture for service if the device failed to work. This troubleshooting guide introduces the suitable actions for correcting the problems or replacing the accessory or calling the service person. It can also help the user to have more exact descriptions of the fault symptoms when call for service, which greatly makes the service fast and efficient. 1. Troubles of the whole machine Fault symptoms Can not turn on the electrocardiograph with mains supply. Can not turn on the electrocardiograph with battery.

Possible cause ① Fuse failure ② Interface board failure ③ Key panel failure ① Battery failure ② Interface board failure ③ Key panel failure

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Correction action ① Change fuse ② Change interface board ③ Change key panel ① Change battery ② Change interface board ③ Change key panel


① strong interference of electric networks ② ARM9 board failure Out of work ③ Power supply or plug-in unit on the master control board failure ① The power supply or Fuse is burned when turning on other component is the electrocardiograph. short-circuited. Fuse is burned when ① This component is connecting a certain short-circuited. component.

① Inspect Power supply and earthing system ② Change ARM9 board ③ Change or repair plug-in unit

① open the electrocardiograph for further examination

① Change this component

2. Display troubles Fault symptoms

Possible cause

Some characters displayed on ① LCD screen failure the LCD screen are missing. ① The brightness of interface board is not LCD screen is dark. adjusted well. ② LCD screen failure

Correction action

① Change LCD screen ① Adjust the adjustable transformer VR1 in the interface board ② Change LCD screen

3. Transmission troubles Fault symptoms

Fail to transmit by net port or serial port Fail to copy to or from U disk

Possible cause

Correction action

①Set and connect again (The ①Setup and connection first three numbers of Local IP error and Remote IP must be set the ②Connection cord failure same.) ③Port failure ②Change connection cord ④IC failure ③Change port ④Change IC

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4. Operation troubles Fault symptoms

Possible cause

Correction action

Key failure

① Key board is damaged ② ARM9 board failure

① Change key board ② Change ARM9 board

No Key Beep or Key Beep is raucous

① Buzzer failure

① Change buzzer

Can not print

Recording is illegible

Some characters or waveform recorded are missing.

Error for detecting paper

① recording paper runs out ② Print-head failure ③ Interface board failure ④ Recorder connection cord failure ① Install the paper roller on the print-head directly. If recording becomes clear, you can confirm that the recorder is not installed well. ② If still illegible, print-head is failure. ① Print-head has stain ② Print-head failure ① There is a stain on the detecting position of the print-head. ② Print-head failure ③ Main board failure

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① Install paper for recorder ② Change print-head ③ Change interface board ④ Change or repair recorder connection cord

① Adjust the installation of recorder ② Change print-head

① Clean print-head ② Change print-head ① Clean the stain on the detecting position of the print-head ② Change print-head ③ Change main board


5. Parameter troubles Fault symptoms

Possible cause

Correction action ① Install electrode clamp again or clean electrode area on body surface with alcohol ② connect the patient cable with the unit ③ Change ECG board ① Install electrode clamp again or clean electrode area on body surface with alcohol ② Change patient cable ③ Change ECG board

Without ECG waveform

① Electrode clamp is not installed well. ② Patient cable is loose from the unit ③ ECG board failure

ECG waveform is abnormal or disturbed

① Electrode clamp is not installed well. ② Patient cable failure ③ ECG board failure

Heart rate is not accurate

① Waveform measuring failure

① Adjust connections

ECG waveform has burr

① Electrode clamp is not installed well. ② ECG board failure

① Install electrode clamp again or clean electrode area on body surface with alcohol ② Change ECG board

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Chapter 6 Electrocardiograph Installation CAUTION

:

Before use, the equipment, patient cable and electrodes should be checked. Replace it if there is any evident defectiveness or aging which may impair the safety or performance. And be sure that the equipment is in proper working condition.

6.1 Power and Earthing WARNING : If the integrity of external protective conductor in installation or arrangement is in doubt, the equipment should be operated from the built-in rechargeable battery. Power Supply The electrocardiograph can be powered either by mains supply or the built-in rechargeable lithium battery pack. 1. Mains supply The mains connection socket is on the left of the unit. If mains supply used, connect the power cord to the socket first, and then connect the plug of the cord to the hospital grade outlet. Rated input voltage: Rated frequency: Rated input power:

100V~115V or 220V~240V 50Hz/60Hz 35VA

Make sure the mains supply meets the above requirements before power on. And then press the mains power switch to power on the unit. Then the mains supply indicator lamp ( ) will be lit. If the built-in rechargeable battery is weak when mains supply used, it will be recharged automatically at the same time. And both the mains supply indicator lamp ( recharging indicator lamp (

) and the battery

) will be lit.

2. Built-in rechargeable battery While using the built-in rechargeable lithium battery pack, turn on the unit by pressing ON/OFF key on control panel directly and the battery indicator lamp ( The battery symbol

) will be lit.

will be displayed on the LCD screen. Because of the consumption

during storage and transport, the capacity of battery may not be full. If the symbol

and the

hint information “BAT WEAK” are displayed, which means the battery capacity is weak, please -27-


recharge the battery first. Please refer to the maintenance section for how to recharge the battery. During recharging the battery, SE-3 can be powered by mains supply at the same time. WARNING

:

Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrical installation when necessary.

6.2 Loading/Replacing Record Paper Two kinds of paper can be used as ECG record paper. One is Rolled thermal paper with 80mm width, and the other is folded thermal paper with 80mm width. Note: When using folded thermal paper, the Paper Roller is unnecessary, and it can be taken out. When there is no record paper loaded or it reaches the end of record paper, warning message “Paper?” will be given on the screen. Under this circumstance, record paper should be loaded or replaced immediately.

Casing

Paper Tray

Paper Roller

Thermal Print Head

Printer Platen

Groove

Loading/Replacing Process for Rolled thermal paper: 1)

Place fingers under the flange of the recorder casing, pull upwards directly to release the casing;

2)

Take out the paper roller, and remove remain paper from the left of roller if necessary;

3)

Take off the wrapper of thermal paper roll, and then put through the roller from the left with the paper’s grid side facing downward; -28-


4)

Place the paper and roller gently in the recorder with the roller pin on the roller’s left side facing to the groove;

5)

Pull about 2cm of paper out, and put down the recorder casing;

6)

Secure the casing by pressing it firmly.

Loading/Replacing Process for Folded thermal paper: 1)

Place fingers under the flange of the recorder casing, pull upwards directly to release the casing;

2)

Remove residual paper in the Paper Tray if necessary;

3)

Take off the wrapper of folded thermal paper, and then put it in the Paper Tray with the paper’s grid side facing the thermal print head while put the free end of paper upright;

4)

Pull about 2cm of paper out, and put down the recorder casing;

5)

Secure the casing by pressing it firmly.

6.3 Patient Cable Connection WARNING

: The performance and electric shock protection can be guaranteed only if original EDAN patient cable and electrodes are used.

Patient cable includes two parts, main cable and lead wires with associated connectors, which can be distinguished from the color and identifier on the connectors.

Main Cable Lead Wires

Screw

Electrode Connectors

Connector

Connect Main Cable: Plug the connector of main cable into the patient cable socket on the right side of the unit according to the direction of arrow on the plug, and then secure it with two screws.

-29-


6.4 Electrodes Connections Chest Electrode:

Suction Bulb

Electrode

Metal Cup

Limb Electrode:

Electrode

Reed Clamp

The identifier and color code of electrodes used complies with IEC/EN requirements. In order to avoid incorrect connections, the electrode identifier and color code is specified in Table 4-1. Moreover the equivalent code according to American requirements is given in Table 4-1 too. Table 4-1 Electrodes and their identifier and color code

European Electrodes

Identifier

American

Color code

Identifier

Color code

Right arm

R

Red

RA

White

Left arm

L

Yellow

LA

Black

Right leg

N or RF

Black

RL

Green

Green

LL

Red

Left leg

F

Chest 1

C1

Red

V1

Red

Chest 2

C2

Yellow

V2

Yellow

Chest 3

C3

Green

V3

Green

Chest 4

C4

Brown

V4

Blue

Chest 5

C5

Black

V5

Orange

Chest 6

C6

Violet

V6

Violet

As the following figure shows, the chest electrodes’ position on body surface is

-30-


C1: Fourth intercostals space at right border of sternum C2: Fourth intercostals space at left border of sternum C3: Fifth rib between C2 and C4 C4: Fifth intercostals space on left midclavicular line C5: Left anterior axillary line at the horizontal level of C4 C6: Left midaxillary line at the horizontal level of C4

C1 C4

C2 C6 C3 C5

The contacting resistance between the patient and the electrode will affect the quality of ECG greatly. In order to get a high-quality ECG, the skin/electrode resistance must be minimized while connecting electrodes. WARNING

: Be sure that all electrodes have been connected to the patient correctly before operation.

WARNING

: Be sure that the conductive parts of electrodes and associated connectors, including neutral electrode, should not contact with earth or any other conducting objects.

Chest electrodes connection: 1)

Ensure the electrodes to be clean firstly;

2)

Align all lead wires of patient cable to avoid twisting, and connect the associated electrode connectors with corresponding electrodes according to the color and identifier;

3)

Clean electrode area on chest surface with alcohol;

4)

Daub the round area of 25mm diameter on each electrode site with gel evenly;

5)

Place a small mount of gel on the brim of chest electrode’s metal cup;

6)

Place the electrode on chest electrode site and squeeze the suction bulb. Unclench it and -31-


then the electrode is adsorbed on chest. Attach all chest electrodes in the same way. Limb electrodes connection: 1)

Ensure the electrodes to be clean firstly;

2)

Align lead wires of patient cable to avoid twisting, and connect the electrode connectors to corresponding electrodes according to the color and identifier;

3)

Clean electrode area on a short distance above the ankle or wrist with alcohol;

4)

Daub the electrode area on limb with gel evenly;

5)

Place a small amount of gel on the metal part of limb electrode clamp;

6)

Connect the electrode to limb, and be sure that the metal part be placed on the electrode area above the ankle or wrist. Attach all limb electrodes in the same way.

6.5 Inspection before Power On In order to avoid safety hazards and get good ECG record, the following inspection procedure is recommended before power on and operation. 1) Environment: ♦

Check and make sure that there is no electromagnetic interference source around the equipment, especially large medical electrical equipment such as electrosurgical equipment, radiological equipment and magnetic resonance imaging equipment etc. Switch off these devices when necessary.

♦

Keep the examination room warm to avoid muscle action voltages in ECG signal caused by cold.

2) Power Supply: ♦

If mains power used, please check whether the power cord has been connected to the unit well. And the grounded three-phase outlet should be used. -32-


♦ 3)

Recharge the battery first when the battery capacity is weak before use. Patient Cable:

♦

Check whether the patient cable has been connected to the unit firmly, and keep it far away from the power cord.

4) Electrodes: ♦

Check whether all electrodes have been connected to lead wires of patient cable correctly according to the identifier and color.

♦

Ensure that the chest electrodes haven’t contacted with each other.

5) Recorder Paper: ♦

Ensure that there is enough recorder paper loaded correctly.

6) Patient: ♦

The patient should not contact with conducting object such as earth, and metal part of bed etc.

♦

Ensure the patient is warm and relaxed, and breathe calmly.

WARNING

: The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained. And they should be familiar with the contents of this user manual before operation.

-33-


Chapter 7 Cleaning 7.1 Clean CAUTION

:

Turn off the power before cleaning and disinfection. Mains supply must be switch off if it has been in use.

7.1.1 Clean the Main Unit and Patient Cable The surface of the main unit and patient cable can be wiped with a clean soft cloth damped in soapy water or non-caustic neutral detergent. After that, remove detergent remainder with a clean dry cloth.

7.1.2 Clean the Electrodes Remove the remainder gel from the electrodes with a clean soft cloth first. Take the suction bulb and mental cup of chest electrodes apart, and take the clamp and the metal part of the limb electrodes apart. Clean them in warm water and be sure there is no remainder gel. Dry the electrodes with a clean dry cloth or air dry naturally.

7.1.3 Clean the Print Head Dirty and soiled thermal print head will deteriorate the record definition. So it should be cleaned at least once a month regularly. Open the recorder casing and remove the paper. Wipe the print head gently with a clean soft cloth damped in 75% alcohol. For stubborn stain, soak it with a little alcohol first and wipe it off with a clean soft cloth. After air dried, load the record paper and shut the casing of the recorder. CAUTION

:

Prevent the detergent from seeping into the main unit while cleaning. Do not immerse the unit or patient cable into liquid under any circumstances. CAUTION

:

Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes. -34-


7.2 Disinfection To avoid permanent damage to the equipment, disinfection can be performed only when it has been considered as necessary according to your hospital’s regulations. Before disinfection clean the equipment first. Then wipe the surface of the unit and patient cable with hospital standard disinfectant. CAUTION

:

Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.

-35-


Chapter 8 Maintenance 8.1 Recharge and Replacement of Battery 1) Capacity Identification Current capacity of the rechargeable battery can be identified according to the battery symbol in the top right corner on LCD screen. : Full capacity : Capacity is limited, and recharge should be taken into account : Battery is weak; and warning message “BAT WEAK” will be displayed on LCD screen. The battery should be recharged immediately 2) Recharge SE-3 is equipped with recharge control circuit together with built-in rechargeable lithium battery. When connect with the mains supply, the battery will be recharged automatically. And then the battery recharge indicator lamp (

) and the mains supply indicator lamp (

will be lit at the same time. During the course of recharging, the symbol “

” will flash in

the top right corner of LCD screen. When the capacity of battery is full, the symbol “ will stop flashing, and the battery recharge indicator lamp (

)

”

) will usually be black. But

if SE-3 is power off, the lamp will still lit just because the equipment will not monitor the recharge status; so you need to power on the device to verify the status. Because of the capacity consumption during storage and transport, the capacity of battery is not full while using at the first time. Battery recharge should be considered before first usage. 3) Replacement When the useful life of battery is over, or foul smell and leakage has been found, please contact with manufacturer or local distributor for replacement of battery. WARNING ♦

:

Only qualified service engineer authorized by EDAN can open the battery compartment and replace the battery. And the battery of same model and specification provided by manufacturer must be used.

♦

Danger of explosion -- Do not reverse the anode and cathode when

-36-


connecting the battery. ♦

When the battery’s useful life is over, contact with the manufacturer or local distributor for disposal or dispose the battery according to local regulations.

8.2 Record Paper Note: Record paper provided by manufacturer should be used. Other paper may shorten thermal print head’s life. And the deteriorated print head may lead to illegible ECG record and block the advance of paper etc. Storage requirements: ♦

Record paper should be stored in dry, dark and cool area, avoiding excessive temperature, humidity and sunshine.

♦

Do not put the paper under fluorescence for long time.

♦

Be sure that there is no polyvinyl chloride or other chemicals in the storage environment, which will lead to color change of the paper.

♦

Do not overlap the recorded paper long time, or else the ECG record may trans-print each other.

8.3 Maintenance of Main Unit, Patient Cable & Electrodes The following safety checks should be performed at least every 24 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests. a) Inspect the equipment and accessories for mechanical and functional damage. b) Inspect the safety relevant labels for legibility. c) Inspect the fuse to verify compliance with rated current and breaking characteristics. d) Verify the device functions properly as described in the instructions for use. e) Test the protection earth resistance according to IEC/EN 60601-1: Limit 0.2ohm. f) Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500uA, SFC 1000uA. g) Test the patient leakage current according to IEC/EN 60601-1: Limit: 10uA (CF). h) Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC/EN 60601-1: Limit: 50uA (CF). The leakage current should never exceed the limit. The data should be recorded in an -37-


equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired. WARNING

:

Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. 1) Main Unit ♦

Avoid excessive temperature, sunshine, humidity and dirt.

♦

Put on the dustproof coat after use and prevent from shaking violently when moving it to another place.

♦

Prevent any liquid from seeping into the equipment, for it will affect the safety and performance of electrocardiograph.

2) Patient Cable ♦

Integrity of patient cable, including main cable and lead wires, should be checked regularly. And be sure that it is conductible.

♦

Do not drag or twist the patient cable with excessive stress while using. Hold the connector plugs instead of the cable when connect or disconnect the patient cable.

♦

Align the patient cable to avoid twisting, knotting or crooking in closed angle while using.

♦

Store the lead wires in bigger wheel to prevent any people from stumbling.

♦

Once damage or aging of the cable patient has been found, replace it with a new one immediately.

3) Electrodes ♦

Electrodes must be cleansed after use and be sure there is no remainder gel on them.

♦

Keep the suction bulb of chest electrode from sunshine and excessive temperature.

♦

After long-term use, the surface of electrodes will be oxidized because of erosion and other causes. By this time, electrodes should be replaced to achieve high-quality ECG.

CAUTION

:

The equipment should be sent to the special agencies according to local regulation for separate collection after its useful life.

-38-


Chapter 9 Technical Specifications Safety

1) EN 60601-1: 1990(A1 + A2),

Standards

2) IEC/EN 60601-1-2: 2001, 3) IEC/EN 60601-2-25, 4) ANSI/AAMI EC-11.

Classification

Anti-electric-shock type:

Class І with internal power supply

Anti-electric-shock degree:

Type CF

Degree of protection against harmful ingress of water:

Ordinary equipment (Sealed equipment without liquid proof)

Disinfection/sterilization method:

Refer to the user manual for details

Degree of safety of application in the presence of flammable gas:

Equipment not suitable for use in the presence of flammable gas

Working mode:

Continuous operation

EMC:

Group І, type A

Dimensions

288mm×210mm×70mm

Weight

About 2.5kg

Display

320×240 dot single color LCD Screen 192×64 dot single color LCD Screen

Environment

Transport /Storage

Working

Temperature:

-20℃~55℃

5℃~40℃

Relative

25%~93%

25%~80%

Non-Condensing

Non-Condensing

700hPa ~1060hPa

860hPa ~1060hPa

Humidity: Atmospheric Pressure: Power Supply

Rated input voltage =100V~115V/220V~240V Mains Supply:

Rated frequency = 50/60Hz Rated input power = 35VA Rated voltage = 14.8V

Built-in Lithium Battery -39-


Pack:

Rated capacity =2000mAh /2200mAh /2400mAh When the capacity of battery is full, SE-3 can work continuously at least 249 minutes. Charge mode: Constant current/voltage Charge current (standard) = 0.2C5A (320mA) Charge voltage (standard) = (17±0.1V) Cycle life ≥ 300 times

Recording

Power Consumption:

35VA (max)

Fuse:

T400mA250V Ø5×20/T200mA 250V Ø5×20

Recorder:

Thermal dot-matrix printer Folded thermal paper, 80mm width

Record Paper: Rolled thermal paper, 80mm width Effective Width: Paper Speed:

HR Recognition

ECG Unit

72mm 5mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s （±3%）

Accuracy of data:

±5% (x-axis), ±5%(y-axis)

Technique:

Peak-peak detection

HR Range:

30 BPM ~300 BPM

Accuracy:

±1BPM

Leads:

12 standard leads

Acquisition Mode:

simultaneously 12 leads

A/D Resolution:

12 bits

Time Constant:

≥3.2s

Frequency Response:

0.05Hz ~ 150Hz

Sensitivity:

2.5, 5, 10, 20 (mm/mV)

Input Impedance:

50M Ω (10Hz)

Input Circuit Current:

≤50nA

Input Voltage Range

<±5 mVpp

-40-


Calibration Voltage:

1mV±3%

Noise:

<12.5 µ Vp-p

Multichannel crosstalk

≤0.5mm AC Filter: On/Off DFT Filter: 0.05/0.15/0.25/0.5

Filter EMG Filter: 25Hz/35Hz/OFF LOWPASS Filter:150Hz/100Hz/75Hz CMRR

≥110dB

Sampling Frequency

1000Hz

Patient Leakage Current:

<10 µ A (220V~240V)

Patient Auxiliary Current:

<0.1 µ A (DC)

Dielectric Strength:

4000V rms

External Input/Output

Input

≥100k Ω ; Sensitivity 10mm/V±5%; Single ended

(Optional) Output

≤100 Ω ; Sensitivity 1V/mV±5%; Single ended

-41-

EDAN INSTRUMENTS, INC. 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan Shenzhen, 518067 P.R. China TEL:86-755-26882220

FAX: ＋86-755-26882223

EC REPRESENTATIVE Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, D-20537 Hamburg Germany TEL: +49-40-2513175

FAX: +49-40-255726

E-mail: [email protected]

EDAN SE-3 Service Manual.pdf

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