EDAN SE-601A User manual

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文件名称：SE-601系列维修手册_英文
文件编号：01.54.110350
版本：1.5
产品型号：SE-601A;SE-601B;SE-601C
项目编码：2201C000
签批信息:
作者 : 肖 丽军 (xiaolijun) 2016-10-11 15:02:00
审核人 : 董 宁 (dongning) 2016-10-12 08:57:03
审核人 : 肖 玉华 (xiaoyuhua) 2016-10-11 16:40:39
批准人 : 王 力维 (wangliwei) 2016-10-13 20:59:28
批准人 : 杨 洁 (yangjie) 2016-10-13 21:03:43
版权©深圳市理邦精密仪器股份有限公司
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I
About this Manual
P/N: 01.54.110350
MPN: 01.54.110350015
Release Date: September 2016
© Copyright EDAN INSTRUMENTS, INC. 2009-2016. All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User‟s operation
failing to comply with this manual may result in malfunction or accident for which EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Product Information
Product Name: Electrocardiograph
Model: SE-601A, SE-601B, SE-601C
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
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II
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.
EDAN will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist service personnel to repair those
parts of the equipment that are designated by EDAN as repairable by service personnel.
Terms Used in this Manual
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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III
Table of Contents
Chapter 1 Warranty and Service..............................................................................................1
Chapter 2 Safety Guidance .......................................................................................................4
2.1 Warnings and Cautions....................................................................................................4
2.1.1 Safety Warnings ....................................................................................................4
2.1.2 Li-ion Battery Care Warnings ...............................................................................7
2.1.3 General Cautions...................................................................................................8
2.2 List of Symbols...............................................................................................................9
Chapter 3 Overview.................................................................................................................13
3.1 Technical Specifications................................................................................................13
3.2 Description of Hardware Design Principle...................................................................14
3.2.1 Main Board Description......................................................................................15
3.2.2 ECG Board Description ......................................................................................16
3.2.3 PS900G Power Supply Module Description.......................................................17
3.2.4 Key Board Description........................................................................................18
3.2.5 WIFI Module Description (Optional) .................................................................18
Chapter 4 Optional andAdvanced Functions.......................................................................19
4.1 Configuring a Bar Code Reader....................................................................................19
4.2Activating SCP/FDA-XML/DICOM Function................................................................22
4.3 Implementing FTP Protocol..........................................................................................22
4.4 Viewing Device Information.........................................................................................28
4.5 Updating by Using A U Disk ........................................................................................29
4.6 Using DEMO Function.................................................................................................29
Chapter 5 Inspection and Troubleshooting............................................................................30
5.1 Function Tests ...............................................................................................................30
5.2 System Tests..................................................................................................................32
5.3 Module Tests .................................................................................................................39
5.3.1 Main Board Test..................................................................................................39
5.3.2 ECG Board Test ..................................................................................................41
5.3.3 Key Board Test....................................................................................................42
5.3.4 Power Supply Board Test....................................................................................43
5.3.5 WIFI Module Test (Optional) .............................................................................44
5.3.6 Display Drive Board Test....................................................................................45
5.4 Troubleshooting ............................................................................................................46
Chapter 6 Electrocardiograph Disassembly..........................................................................51
6.1 Disassembly Procedures ...............................................................................................51
6.2 Internal Boards and Interfaces ......................................................................................56
Chapter 7 Renewable Parts.....................................................................................................64
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SE-601 Series Electrocardiograph Service Manual Warranty and Service
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Chapter 1 Warranty and Service
Standard Service
EDAN provides a one-year-warranty for the warranted products (accessories are included). The
warranty period begins on the date the products are shipped to customers. If a customer promptly
notifies EDAN of customer‟s warranty claim hereunder, EDAN will either repair, adjust or
replace (with new or exchange replacement parts) EDAN‟s products. EDAN warrants that any
service it provides to customers will be performed by trained individuals in a workmanlike
manner.
Limitation of Warranty
Direct, indirect or final damage and delay caused by the following situations for which EDAN is
not responsible may void the warranty:
Groupware is dismounted, stretched or redebugged.
Unauthorized modification or misuse.
Damage caused by operating beyond the environmental specifications for the medical
product.
Change or remove original serial number label or Manufacturer symbol.
Improper use.
Service Procedure
(1) Fill in the Service Claim Form (SCF).
Fill in the SCF with detailed information including: Model Name, Serial Number (SN) and
Problem Phenomena.
EDAN should not have any obligation to take over the case without this information. The
form can be downloaded at: http://www.edan.com.cn or obtained from EDAN‟s Service
Department.
(2) Send EDAN the SCF and Select a Solution.
Once the service department receives the fully filled SCF, EDAN‟s engineer will offer a
solution in three working days. EDAN will follow out the case based on the two conditions
below:
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SE-601 Series Electrocardiograph Service Manual Warranty and Service
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Within Warranty:
There are two options:
i) After receiving the Return Material Authorization (RMA) form from EDAN service
department, the customer sends EDAN the defective parts and informs about the shipment
tracking number. Then we will dispatch new part(s) to your confirmed address with
confirmed shipping invoice.
ii) The customer signs the Declaration Form and sends it back by email or fax. This form is
legally certificated to make sure the customer or end-user will return the defective parts to
EDAN on time. We will, at this option, dispatch the replacement one(s) with confirmed
shipping invoice.
NOTE:
(1) Both Return Material Authorization Form and Declaration Form are offered
by EDAN service department once the SCF is confirmed by service engineer.
(2) The customer is responsible for freight & insurance charges when the
equipment is shipped to EDAN for service, including custom charges. EDAN
is responsible for the freight, insurance & custom charges from EDAN to the
customer.
Out of Warranty:
After receiving the RMA form from the service department, the customer sends defective
parts to EDAN. We will analyze the problems and discuss with the customer about either
repairing or replacing the part(s). Once the maintenance fee is invoiced and paid, we will
make sure to dispatch good part(s) to the confirmed address.
NOTE: The customer is responsible for any freight & insurance charge for the
returned product.
(3) Obtain the RMA Form.
Before the shipment of the materials, the customer must obtain an RMA form from our
service department, in which the RMA number, description of returning parts and shipping
instructions are included. The RMA number should be indicated on the outside of the
shipping container.
NOTE: EDAN should not have any obligation to the end-user or customer who
returns the goods without the notification by EDAN’s service department.
The sender takes full responsibility for the accounted fee.
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SE-601 Series Electrocardiograph Service Manual Warranty and Service
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(4) Send the Parts to EDAN.
Follow these recommended instructions:
Please disassemble the parts with anti-static facility, do not touch the parts with naked hand.
Please pack the parts safely before return.
Please put the RMA number on the parcel.
Please describe the returned parts as „sample of *****‟ and put the total value on the invoice,
and note on the invoice as „sample, no commercial value‟.
Please confirm the invoice with Edan before shipment.
Please send back the parts after Edan‟s confirmation.
Contact Information
If you have any question about maintenance, technical specifications or malfunctions of devices,
do not hesitate to contact us.
EDAN Instruments, Inc.
TEL: [phone]
FAX: [phone]
E-mail: [email protected]
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SE-601 Series Electrocardiograph Service Manual Safety Guidance
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Chapter 2 Safety Guidance
This chapter provides important safety information related to the use of SE-601 series
electrocardiograph.
2.1 Warnings and Cautions
In order to use the electrocardiograph safely and effectively, and avoid possible dangers caused
by improper operation, please read through the user manual and be sure to be familiar with all
functions of the equipment and proper operation procedures before use.
Please pay more attention to the following warning and caution information.
2.1.1 Safety Warnings
WARNING
1. The electrocardiograph is intended to be used by qualified physicians or personnel
professionally trained. They should be familiar with the contents of this user manual
before operation.
2. Only qualified service engineers can install this equipment, and only service
engineers authorized by the manufacturer can open the shell.
3. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of
flammable anesthetic mixtures with oxygen or other flammable agents.
4. SHOCK HAZARD - The power receptacle must be a hospital grade grounded outlet.
Never try to adapt the three-prong plug to fit a two-slot outlet.
5. Make sure that the power is turned off and the power cord is disconnected from the
AC socket before connecting or disconnecting equipment. Otherwise, electrical shock
or other injuries may happen to the patient or operator.
6. If the integrity of the external protective conductor is in doubt, the equipment should
be powered by an internal li-ion rechargeable battery.
7. Do not use this equipment in the presence of high static electricity or high voltage
equipment which may generate sparks.
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SE-601 Series Electrocardiograph Service Manual Safety Guidance
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WARNING
8. Only the patient cable and other accessories supplied by the manufacturer can be
used. Or else, the performance and electric shock protection can not be guaranteed.
The electrocardiograph has been safety tested with the recommended accessories,
peripherals, and leads, and no hazard is found when the electrocardiograph is
operated with cardiac pacemakers or other stimulators.
9. Make sure that all electrodes are connected to the patient correctly before operation.
10.Ensure that the conductive parts of electrodes and associated connectors, including
neutral electrodes, do not come in contact with earth or any other conducting objects.
11.Disposable electrodes must be used during defibrillation.
12.Electrodes of dissimilar metals should not be used; otherwise it may cause a high
polarization voltage.
13.The disposable electrodes can only be used for one time.
14.Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.
15.Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously.
16.The use of equipment that applies high frequency voltages to the patient (including
electrosurgical equipment and some respiration transducers) is not supported and
may produce undesired results. Disconnect the patient data cable from the
electrocardiograph, or detach the leads from the patient prior to performing any
procedure that uses high frequency surgical equipment.
17.If WIFI technology is used, in order to maintain compliance with the FCC RF exposure
guidelines, WIFI should be installed and operated with a minimum distance of 20cm
between the radiator and the human body. There should be no shield in or around the
room where WIFI is used.
18.Fix attention on the examination to avoid missing important ECG waves.
19.SHOCK HAZARD - Don’t connect non-medical electrical equipment, which has been
supplied as a part of the system, directly to the wall outlet when the non-medical
equipment is intended to be supplied by a multiple portable socket-outlet with an
isolation transformer.
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SE-601 Series Electrocardiograph Service Manual Safety Guidance
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WARNING
20.SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.
21.Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1-1 approved to the electrocardiograph.
The operation or use of non-approved equipment or accessories with the
electrocardiograph is not tested or supported, and electrocardiograph operation and
safety are not guaranteed.
22.Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
23.Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.
24.Multiple portable socket-outlets shall not be placed on the floor.
25.Do not use the additional multiple portable socket-outlet or extension cord in the
medical electrical system, unless it’s specified as part of the system by manufacturer.
And the multiple portable socket-outlets provided with the system shall only be used
for supplying power to equipment which is intended to form part of the system.
26.Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the standard IEC/EN 60601-1-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN 60601-1-1. If in
doubt, consult our technical service department or your local distributor.
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SE-601 Series Electrocardiograph Service Manual Safety Guidance
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WARNING
27.Connecting any accessory (such as external printer) or other device (such as the
computer) to this electrocardiograph makes a medical system. In that case, additional
safety measures should be taken during installation of the system, and the system
shall provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
28.All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
29.If multiple instruments are connected to a patient, the sum of the leakage currents
may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
Consult your service personnel.
30.The potential equalization bar can be connected to that of other equipment when
necessary. Make sure that all the equipment is connected to the potential equalization
terminal.
2.1.2 Li-ion Battery Care Warnings
WARNING
1. Improper operation may cause the internal li-ion battery (hereinafter called battery) to
be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It
is necessary to read the user manual carefully and pay more attention to warning
messages.
2. Only qualified service engineers authorized by the manufacturer can open the battery
compartment and replace the battery, and batteries of the same model and
specification as manufacturer configuration should be used.
3. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when
installing the battery.
4. Do not heat or splash the battery or throw it into fire or water.
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SE-601 Series Electrocardiograph Service Manual Safety Guidance
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WARNING
5. Do not destroy the battery; Do not pierce battery with a sharp object such as a needle;
Do not hit with a hammer, step on or throw or drop to cause strong shock; Do not
disassemble or modify the battery.
6. When leakage or foul smell is found, stop using the battery immediately. If your skin or
cloth comes into contact with the leakage liquid, cleanse it with clean water at once. If
the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with clean
water first and go to see a doctor immediately.
7. Properly dispose of or recycle the depleted battery according to local regulations.
8. Only when the device is off can the battery be installed or removed.
9. Remove the battery from the electrocardiograph when the electrocardiograph isn’t
used for a long time.
10.If the battery is stored alone and not used for a long time, we recommend that the
battery be charged at least once every 6 months to prevent overdischarge.
2.1.3 General Cautions
CAUTION
1. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and
55 ºC during transportation and storage.
2. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.
3. Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters or mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. is likely to bring electromagnetic
interference.
4. Ruptured fuse must only be replaced with that of the same type and rating as the
original.
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SE-601 Series Electrocardiograph Service Manual Safety Guidance
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CAUTION
5. The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of
them together with house-hold garbage. At the end of their lives hand the batteries
over to the applicable collection points for the recycling of waste batteries. For more
detailed information about recycling of this product or battery, please contact your
local Civic Office, or the shop where you purchased the product.
6. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
2.2 List of Symbols
No.
Symbol
Description
1
External input/output
2
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
3
Attention, consult ACCOMPANYING DOCUMENTS
4
Operating instructions
5
Equipotential grounding
6
Patient Cable Socket
7
USB socket
8
Net port
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SE-601 Series Electrocardiograph Service Manual Safety Guidance
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9
Alternating Current
10
Battery check
11
Battery recharging indicator
12
Delete key
13
Enter key
14
Esc key
15
Space key/Feed paper key
16
Shift key
17
Fn key
18
Power On/Off key
19
1mV/COPY key
20
MODE key
21
RESET key
22
PRINT/STOP key
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SE-601 Series Electrocardiograph Service Manual Safety Guidance
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23
Tab paper key
24
Gender key
25
Age Group key
26
General symbol for recovery/recyclable
27
Part Number
28
SERIAL NUMBER
29
Date of manufacture
30
MANUFACTURER
31
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
32
CE marking
33*
With respect to electrical shock, fire and mechanical
hazards only in accordance with UL 60601-1 and
CAN/CSA C22.2 No. 601.1
34
Caution: Federal (U.S.) law restricts this device to sale by
or on the order of a physician.
35
Disposal method
36
Refer to User Manual
(Background: Blue; Symbol: White)
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SE-601 Series Electrocardiograph Service Manual Safety Guidance
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37
Warning
(Background: Yellow; Symbol&Outline: Black)
38*
Non- ionizing electromagnetic radiation
39*
Contains FCC ID:
YOPGS2011MIZ
Federal Communications Commission:
Contains FCC ID: YOPGS2011MIZ
NOTE:
1. 33* The UL mark is optional.
2. 38*, 39*: Applicable to SE-601B/C.
3. The manual is printed in black and white.
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SE-601 Series Electrocardiograph Service Manual Overview
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Chapter 3 Overview
The service manual is a reference for periodic preventive maintenance and corrective service
procedures for SE-601 series electrocardiograph.
WARNING
When performing a service procedure, follow the instructions in this manual exactly.
Failure to do so could damage the device, invalidate the product warranty, and lead to
serious personal injury.
This guide provides troubleshooting information, disassembly procedures, and instructions for
functional testing and performance verification. It is intended to be used by technically
qualified service personnel only.
3.1 Technical Specifications
Safety Standards:
IEC 60601-1:2005/A1:2012
EN 60601-1:2006/A1:2013
IEC 60601-1-2:2007
EN 60601-1-2:2007/AC:2010
IEC 60601-2-25:2011
Classifications:
Anti-electric-shock type:
Class І with internal power supply
Anti-electric-shock degree:
CF type with defibrillation-proof
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:
CISPR 11 Group 1, Class A
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SE-601 Series Electrocardiograph Service Manual Overview
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Environment Requirements:
Transport and Storage
Working
Temperature:
-20ºC (-4ºF) ~ +55ºC (+131ºF)
+5ºC (+41ºF) ~ +40ºC (+104ºF)
Relative Humidity:
25%RH~93%RH
Non-Condensing
25%RH~80%RH
Non-Condensing
Atmospheric Pressure:
70 kPa ~106 kPa
86 kPa ~106 kPa
Power Supply Specifications:
1) Mains Supply:
Operating Voltage: 100V-240V~
Operating Frequency: 50Hz/60Hz
Input Power = 0.9A-0.4A
2) Internal li-ion rechargeable battery:
Rated voltage: 14.8V; Rated capacity: 2500mAh
3) Fuse Specification: T3.15AH250V, Ø5×20mm
3.2 Description of Hardware Design Principle
Main Board
Printer ECG Board
Power Supply
Board
LCD
Display Key Board
UART
I/O 5V, 12V,
8.3V
WIFI
Module
(optional)
Speaker or
buzzer
UART
AC Li-ion
Battery
I/O
Figure 3-1 Block Diagram of the Electrocardiograph
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SE-601 Series Electrocardiograph Service Manual Overview
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SE-601 series electrocardiograph consists of the following functional blocks:
1) Key board
2) Main board
3) PS900G power supply board
4) ECG board
5) Thermal printer module
6) LCD display module
7) WIFI module (optional)
8) Speaker or buzzer
3.2.1 Main Board Description
The main board includes Core CPU, SDRAM, FLASH, buffer chip, Ethernet driver chip, power
supply, printing interface, audio interface, TFT screen interface, USB interface, RS232-Serial
port, analog input and output.
CPU, SDRAM,
FLASH, CS8900,
74LVTH162245
232
Coversion
10/100M
Ethernet
Audio
Circuit
TFT LCD
Signal
Driver or
Conversion
Power
Supply
CPLD
USB
DEVICE
Interface
USB HOST
Interface
UART1
UART0
ECG
Board
Interface
UART2
Analog Signals
input/output
Key
Board
Interface
601B/C
LCD
Interface
RS232
Interface
Printer Interface
SE-601A
LCD
Interface
Speaker
Isolation
Transformer
Circuit Feedback
Detection
Analog Signals
input/output
WIFI Interface
(optional)
UART0
SPI 0
Figure 3-2 Main Board Diagram
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