• Author / Uploaded
• Edgar Osorio

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• Presión sanguínea
• Corriente continua
• Monitor de computadora
• Diodo emisor de luz
• Diástole

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About this Manual P/N: 01.54.112597-10 Release Date: June 2010 © Copyright EDAN INSTRUMENTS, INC. 2010. 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.

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. 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.

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. I

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.

II

Table of Contents Chapter 1 Warranty and Service................................................................................................. 1 1.1 Standard Service................................................................................................................. 1 1.2 Limitation of Warranty ...................................................................................................... 1 1.3 Service Procedure............................................................................................................... 1 1.4 Contact Information ........................................................................................................... 3 Chapter 2 Installation and Safety................................................................................................ 4 2.1 Environment Requirements................................................................................................ 4 2.2 Electrical Requirements ..................................................................................................... 5 2.3 Safety Requirements .......................................................................................................... 5 2.4 Installing the Monitor......................................................................................................... 6 2.4.1 Install the Monitor on a Flat Surface........................................................................ 6 2.4.2 Mount the Monitor on Wall ..................................................................................... 6 2.4.3 Install the Monitor on Pole Clamp ........................................................................... 6 2.4.4 Install the Monitor on Trolley .................................................................................. 6 Chapter 3 Functional Checks....................................................................................................... 7 3.1 Powering on the Monitor ................................................................................................... 7 3.2 LCD Screen Check............................................................................................................. 7 3.3 Keys Check ........................................................................................................................ 7 3.4 Alarms Check..................................................................................................................... 7 Chapter 4 System Configuration ................................................................................................. 8 4.1 Enter Factory Maintain ...................................................................................................... 8 4.2 Enter Demo Mode .............................................................................................................. 9 4.3 Default Configuration ........................................................................................................ 9 Chapter 5 System Principle........................................................................................................ 11 5.1 Principle ........................................................................................................................... 11 5.1.1 NIBP....................................................................................................................... 12 5.1.2 SpO2 ....................................................................................................................... 12 5.1.3 TEMP ..................................................................................................................... 13 5.2 Principle Block Diagram.................................................................................................. 13 Chapter 6 Test and Maintenance............................................................................................... 26 6.1 Maintenance Inspection ................................................................................................... 26 6.2 Maintenance of the Monitor............................................................................................. 26

III

6.3 Maintenance of Sensors ................................................................................................... 26 6.4 NIBP Calibration.............................................................................................................. 27 Chapter 7 Troubleshooting ........................................................................................................ 28 7.1 Monitor Booting Failure .................................................................................................. 28 7.2 Display Failure ................................................................................................................. 29 7.3 Operation Failure ............................................................................................................. 29 7.4 Network Failure ............................................................................................................... 29 7.5 Power Board Failure ........................................................................................................ 30 7.6 Alarm Failure ................................................................................................................... 30 7.7 Parameter Failure ............................................................................................................. 30 Chapter 8 Modules’ Malfunction Verification ......................................................................... 32 Chapter 9 Disassembling the Monitor....................................................................................... 40 9.1 Tools Required ................................................................................................................. 40 9.2 Replacing Fuses ............................................................................................................... 40 9.3 Disassembling the Main Unit........................................................................................... 42 9.4 Disassembling Rear Panel Assembly............................................................................... 47 9.5 Disassembling Front Panel Assembly.............................................................................. 54 Chapter 10 Renewal Parts.......................................................................................................... 57 Appendix 1 Specification ............................................................................................................ 59 A1.1 Classification................................................................................................................. 59 A1.2 Specifications ................................................................................................................ 59 A1.2.1 Size and Weight .................................................................................................. 59 A1.2.2 Environment ........................................................................................................ 59 A1.2.3 Display ................................................................................................................ 60 A1.2.4 Battery ................................................................................................................. 61 A1.2.5 Review................................................................................................................. 61 A1.2.6 NIBP (Optional) .................................................................................................. 61 A1.2.7 SpO2 (Optional)................................................................................................... 62 A1.2.8 TEMP (Optional)................................................................................................. 63

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M3A Vital Signs Monitor Service Manual

Warranty and Service

Chapter 1 Warranty and Service 1.1 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.

1.2 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.

1.3 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: 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. -1-

M3A Vital Signs Monitor Service Manual

Warranty and Service

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 in advance. 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. (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.

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M3A Vital Signs Monitor Service Manual

Warranty and Service

1.4 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: +86-755-26898321, 26899221 FAX: +86-755-26882223, 26898330 E-mail: [email protected]

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M3A Vital Signs Monitor Service Manual

Installation and Safety

Chapter 2 Installation and Safety WARNING Only qualified service engineers can install this equipment. And only service engineers authorized by EDAN can open the shell.

2.1 Environment Requirements The environment where M3A Vital Signs Monitor (hereinafter called monitor) will be used should be reasonably free from vibration, dust, corrosive or explosive gases, extremes of temperature, humidity, and so on. Size

200.8 mm (L)×241 mm (H)×189 mm (D)

Temperature Working

+5 C ~ +40 C

Transport and Storage

-20 C ~ +55 C

Humidity Working

25% ~ 80% (no condensing)

Transport and Storage

25% ~ 93% (no condensing)

Altitude Working

860hPa ~ 1060hPa

Transport and Storage

700hPa ~ 1060hPa

CAUTION 1 If the monitor is installed in a cabinet, allow at least 2 inches (5 cm) clearance around the monitor for proper air circulation; allow adequate accessibility for servicing, and adequate room for visualization and operation. 2 Ensure the monitor is not subjected to any source of strong electromagnetic interference, such as CT, radio transmitters, mobile phones base stations, etc. 3 Do not install the monitor in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur. 4 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust area, high-temperature and humid environment.

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M3A Vital Signs Monitor Service Manual

Installation and Safety

2.2 Electrical Requirements Power Supply

Voltage: 100V-240V ~ Frequency: 50Hz/60Hz Pmax: 70VA Battery: 14.8 V/4.4 Ah; 14.8 V/2.2 Ah.

2.3 Safety Requirements The monitor complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1, it is ClassⅠequipment and internally powered equipment. Anti-electroshock degree:

NIBP, SpO2 This symbol indicates that the instrument is IEC/EN60601-1 Type BF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation.

TEMP This symbol indicates that the instrument is IEC/EN60601-1 Type CCF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is not suitable for use during defibrillation. CAUTION 1 SHOCK HAZARD- the power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet. If the outlet has only two slots, make sure that it is replaced with a three-slot grounded outlet before attempting to operate the monitor. 2 Do not touch signal input or output connector and the patient simultaneously. 3 Equipment and devices that connect to the monitor should form an equipotential body to ensure effective grounding. 4 Do not switch on the monitor until all cables have been properly connected and verified.

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Installation and Safety

2.4 Installing the Monitor 2.4.1 Install the Monitor on a Flat Surface Place the monitor on a flat surface. Make sure the surface does not vibrate, and is free of corrosive medicine and dust.

Figure 2-1 M3A monitor on a flat surface

2.4.2 Mount the Monitor on Wall To mount the monitor on a wall, you need to order a Wall Mounting Bracket (02.01.109481). Please refer to that instruction for details of installation.

2.4.3 Install the Monitor on Pole Clamp An Assembling Instruction will be delivered with the 1-piece/4-piece Pole Clamp (02.01.109592 or 02.01.109636). Please refer to that instruction for details of installation.

2.4.4 Install the Monitor on Trolley An Assembling Instruction will be delivered with the Trolley (12.01.109480). Please refer to that instruction for details of installation.

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M3A Vital Signs Monitor Service Manual

Functional Checks

Chapter 3 Functional Checks This chapter describes the procedure for a complete functional test to support recommended preventive-maintenance schedules. Function checks do not require opening the device case. WARNING Only qualified service personnel should perform a full function check procedure. Whenever the monitor is serviced or problems are suspected, the manufacturer recommends a full function check procedure.

3.1 Powering on the Monitor Press the ON/OFF button on the front panel to power on the monitor, all the seven-segment displays are bright, and LOGO information is displayed on the screen. If any failure is detected, refer to section 7.1 Monitor Booting Failure for details.

3.2 LCD Screen Check 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. If any failure is detected, refer to section 7.2 Display Failure for details.

3.3 Keys Check Press the keys on the front panel to check if they work properly. When pressing a key, a normal key tone should be heard, unless its related function is disabled. If any failure is detected, refer to section 7.3 Operation Failure for details.

3.4 Alarms Check Stimulate a signal that is higher than the upper limit or lower than the lower limit to activate a physical alarm. Disconnect one of the plugs of the monitor to activate a technical alarm. Check if the audible alarms and visible alarms are working properly. If any failure is detected, refer to section 7.5 Alarm Failure for defective details.

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M3A Vital Signs Monitor Service Manual

System Configuration

Chapter 4 System Configuration The end users can not change the system configuration of the monitor. As a service engineer, you need to change the configuration for them after the monitor is installed and checked properly. NOTE: Restart the monitor after changing the settings.

4.1 Enter Factory Maintain Press the MENU button on the front panel to open Main Menu. You can perform the following operations in this menu.

Figure 4-1 System Memu

Select Maintenance >> in Main Menu to open the following menu. Factory Maintenance is only available for the service engineers of EDAN or representatives authorized by EDAN.

Figure 4-2 Select Factory Maintenance

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M3A Vital Signs Monitor Service Manual

System Configuration

Input the factory password 9 9 8 0 in the Enter Password box as follows and press Confirm:

Figure 4-3 Enter Maintain Password

Factory Maintenance menu will pop up, in which you can set the following items.

Figure 4-4 Factory Maintain

－ Module: you can set the configuration function. － Reset All Config: you can reset all the configuration of the monitor by this item. － Firmware Update: connect the PC and monitor by network cable, then you can do online update.

4.2 Enter Demo Mode Press the MENU button to display Main Menu, then select Maintenance > Demo, Input the demo password 3 0 4 5 in the Enter Password box and press Confirm to enter Demo mode.

4.3 Default Configuration Press the MENU button to display Main Menu, select System Setup > Default Configuration to display the following menu: NOTE: Select any item in this submenu to cancel the current setup and use the selected default setup.

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M3A Vital Signs Monitor Service Manual

System Configuration

Figure 4-5 Default Menu

 Factory Default Config: select the factory default configuration;  User Default Config: select the user-defined default configuration;  Restore Selected Config: select this item to restore the selected configuration;  Save as User Default Config: save the current setup as the user default configuration;  Exit: exit this submenu and return to the previous menu.

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M3A Vital Signs Monitor Service Manual

System Principle

Chapter 5 System Principle This chapter introduces the structure and principle of the monitor, as well as the principles and port definitions of the modules.

5.1 Principle Parameter module is the basic unit to acquire signals for monitoring parameters in monitor. The monitoring signals are transmitted to main control board to accomplish processing and displaying of data and waveforms. The power link board can realize power switching and conversion. The whole system structure is shown in the following figure: Medical staff

Keyboard

Monitor

Power supply

Main control board

NIBP

SpO2

Keyboard

TEMP

Patient

Figure 5-1 System structure

As shown in the above figure, the three parameter modules execute real-time monitoring of NIBP, SpO2, and TEMP respectively by using cuff and measuring cables, the results can be sent to main control board for processing and displaying. Hereinafter the function details of parameter monitor will be explained.

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M3A Vital Signs Monitor Service Manual

System Principle

5.1.1 NIBP Blood pressure monitors commonly measure arterial pressure, which is produced by the contraction of the heart and constantly changes over the course of cardiac cycle. Three blood pressure values, expressed in millimeters of mercury above atmospheric pressure, are obtained. The systolic pressure is the maximum cycle pressure; which occurs during ventricular contraction. The diastolic pressure is the minimum cycle pressure, occurring during the ventricle’s filling stage between contractions. The means arterial pressure (MAP) is the mean value of the blood pressure over the cardiac cycle. The monitor measures non-invasive blood pressure using the oscillometry method. The following are detailed measurement procedures. Inflate the cuff encircling the upper arm until the pressure in the cuff blocks the blood flow in the artery of the upper arm. Then deflate the cuff gradually according to the requirement of certain arithmetic. With the decreasing of the pressure in the cuff, the artery blood will palpitate with the pulse, which results in palpitation in the cuff. Through the pressure sensor connected with the inflating pipe of the cuff, a palpitation signal palpitating with the pulse will be generated. After being filtered by a high-pass filter (about 1Hz), this signal becomes pulsating signal and is amplified. Then the amplified signal is converted into digital signal by A/D. After using the singlechip to process this digital signal, we may obtain systolic pressure, diastolic pressure and mean pressure. Be careful to choose appropriate cuffs for neonatal, pediatric and adult patients so as to avoid generating measurement error. NIBP module also has protection circuit to prevent the cuff from being inflated to a very high pressure. The following are the main operating modes of NIBP. a.

Adult/pediatric/neonate: select according to the patient shape, weight and age.

b.

Manual measurement/auto measurement/continuous measurement: Manual measurement is also called single measurement. It means the monitor performs only one measurement each time. Auto measurement means to perform one measurement within selected cycle. Time interval can be set to 1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 240 or 480 minutes. Continuous measurement means after being activated, the monitor will perform quick measurement continuously within 5 minutes. Continuous measurement is effective in monitoring changes in blood pressure.

5.1.2 SpO2 SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained. By tracing the pulse waveform in the fingertip, using specified arithmetic and consulting the clinical data table, we can obtain the SpO2 value. The SpO2 sensor consists of two LEDs and a photodetector. The two LEDs are respectively red diode and infrared diode, which are lighted on according to certain time sequence. When the capillary vessel of the fingertip congests repeatedly, the light of the LED is absorbed by blood vessels and organs and then projected onto the photodetector. The photodetector can detect the light intensity varying with pulse changes and - 12 -

M3A Vital Signs Monitor Service Manual

System Principle

display the changing light intensity in the form of changing electronic signals. The ratio between the DC and AC of the two types of signals for light is the proportion of oxygen in the blood. Then we can calculate correct SpO2 value by using specified arithmetic and also calculate pulse rate according to the SpO2 waveform. The SpO2 module mainly consists of the following four parts: sensor, signal processing, control unit of LED driving sequence, singlechip.

5.1.3 TEMP The temperature of human body is first converted into electronic signals, which are then amplified by amplifier and processed. In this way we can obtain the TEMP value. The circuit includes proportional amplifier constructed by operational amplifiers. The temperature passes the thermal sensor, producing pressure signals, which are amplified and transmitted to A/D converter for further processing.

5.2 Principle Block Diagram The following figure shows the hardware structure of the whole monitor and the connection relationships between different parts. The boards displayed in the figure are the core part of the monitor, i.e. main control board and parameter board.

Recorder

J3

记录仪 J6

SpO2 sensor/NIBP cuff SPO2探头/NIBP袖带

TEMP sensor 快速体温探头

J5 X2参数板 X2 board J2

T2 TEMP board T2体温模块

J1 J2

J9 Power Power control part 电源控制板 电源板 board J4&J2

J1

J5

J1 Power link board 电源接口板 JP1 F1&F2

Li 锂电池 battery

A

AC C input

输 入

J1 J2

J6 J9

J5

J1 J2 网络接口板 Network link

J3 Main control 主控板board J7

扬声 Speaker

board

保 Fuse 险 管

Figure 5-2 Block diagram of monitor - 13 -

器

J4 J10

3.5" LCD

M3A Vital Signs Monitor Service Manual

System Principle

NOTE: The nurse call board and the network board are optional configurations, they can not be installed at the same time. If you want to use the nurse call function, you should install the nurse call board, otherwise you should install the network board.

5.2.1 Main Control Board The block diagram of main control board is displayed as follows: 7-segment 数码管+LED显示 +LED display

7-segment

Communication 通信接口 port

数码管显示驱动 display driver

LCD display LCD显示 Main control 主控制器 unit LCD display

LCD显示驱动 driver Power 电源管理 management

Keyboard 按键

Figure 5-3 Block diagram of main control board

Main control board is the core module of system, it can realize the functions of display, keyboard input, alarm control, module control, etc. According to the function, main control board consists of main control unit, power management, LCD display driver, 7-segment display driver, communication port and keyboard. The main control unit adopts Cortex-M3 core, the display adopts 7-segment and LCD and the keyboard can realize the basic information input. There are different ports on main control board, the port definitions are displayed as follows.

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M3A Vital Signs Monitor Service Manual

5.2.1.1

System Principle

Power Input Port

Pin NO. Power input

5.2.1.2

Definition

1

+5V

2

GND

3

GND

4

+12V

Input Port of Power Control Signal

Pin NO. Power control

Definition

1

PWR_TXD

2

PWR_RXD

3

GND

4

PWR_CHARGE

5

PWR_ACON

6

PWR_SWITCH

7

GND - 15 -

M3A Vital Signs Monitor Service Manual

5.2.1.3

System Principle

X2 Module Port

X2 module

5.2.1.4

Pin NO.

Definition

1

NC

2

+5V

3

+12V

4

GND

5

X2_TXD

6

X2_RXD

Pin NO.

Definition

T2 Module Port

T2 Module

1

5V

2

GND

3

T2_TXD

4

T2_RXD - 16 -

M3A Vital Signs Monitor Service Manual

5.2.1.5

System Principle

Network Interface Board Port

J5

Pin NO. Network module

5.2.1.6

Definition

1

3.3V

2

GND

3

LAN_TXD

4

LAN_RXD

Recorder Port

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M3A Vital Signs Monitor Service Manual

System Principle

Pin NO. Recorder

5.2.1.7

Definition

1

PPRT_STB

2

PPRT_D0

3

PPRT_D1

4

PPRT_D2

5

PPRT_D3

6

PPRT_D4

7

PPRT_D5

8

PPRT_D6

9

PPRT_D7

10

PPRT_ACK

11

PPRT_BUSY

12

PPRT_PE

13

PPRT_ERR

14

GND

15

GND

16

NC

17

NC

18

NC

19

NC

20

GND

Speaker Port

J7

Pin NO. Speaker

Definition

1

AUDIO_IN

2

AUDIO_OUT - 18 -

M3A Vital Signs Monitor Service Manual

5.2.1.8

System Principle

FPC Port of LCD Screen

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M3A Vital Signs Monitor Service Manual

System Principle

Pin NO. FPC port of LCD 1 screen 2

Definition BL_FB BL_FB

3

V_BACKLIGHT

4

V_BACKLIGHT

5

NC

6

NC

7

NC

8

LCD_RESET

9

NC

10

NC

11

NC

12

BB0

13

BB1

14

BB2

15

BB3

16

BB4

17

BB5

18

BB6

19

BB7

20

GG0

21

GG1

22

GG2

23

GG3

24

GG4

25

GG5

26

GG6

27

GG7

28

RR0

29

RR1

30

RR2

31

RR3

32

RR4

33

RR5

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M3A Vital Signs Monitor Service Manual

5.2.1.9

System Principle

34

RR6

35

RR7

36

HSYNC

37

VSYNC

38

DCLK1

39

NC

40

NC

41

+3V3

42

+3V3

43

NC

44

NC

45

NC

46

NC

47

NC

48

GND

49

GND

50

GND

51

NC

52

GND

53

GND

54

GND

Nurse Call Port

J9

Pin NO. Nurse call

Definition

1

+12V

2

NURSE_CALL

3

GND - 21 -

M3A Vital Signs Monitor Service Manual

System Principle

5.2.1.10 JTAG Port

Pin NO. Nurse call

Definition

1

+3V3

2

TDI

3

TMS

4

TCK

5

TDO

6

GND

5.2.2 Network Interface Board 5.2.2.1

Nurse Call Port

Pin NO. Nurse call

Definition

1

+12V

2

NURSE_CALL

3

GND - 22 -

M3A Vital Signs Monitor Service Manual

5.2.2.2

System Principle

Communication Port

Pin NO. Communication port

5.2.2.3

Definition

1

3.3V

2

GND

3

TXD

4

RXD

Network Port

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M3A Vital Signs Monitor Service Manual

System Principle

Pin NO. Network port

Definition

1

ETN_TX+

2

ETN_TX-

3

ETN_RX+

4

NC

5

GND1

6

ETN_RX-

7

T1

8

T2

5.2.3 Power Module The power module can provide DC power supply to other boards. Principle Block Diagram Battery

Fan

Power module

Power control board

Figure 5-4 Block diagram of power board

Principle Introduction This module converts +220 V AC mains power supply or battery power into +5 V and +12 V DC supplies to power other boards. If AC mains and battery coexist, the former take the priority to power the system and charge the latter at the same time. AC/DC Converts high-voltage AC supply into low-voltage DC supply to power subsequent circuits and charge the battery.

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M3A Vital Signs Monitor Service Manual

System Principle

Battery Control Circuit If AC supply and battery coexist, this circuit controls the output from AC/DC part to charge the battery. If AC supply is disconnected, this circuit controls the battery to power the subsequent circuits. +5 V DC Convert the DC supply from the previous circuit into stable +5 V DC supply to power other boards. +12 V DC Convert the DC supply from the previous circuit into stable +12 V DC supply to power other boards. Power Switch Circuit Control the working status of +5 V DC and +12 V DC in order to control ON/OFF action of the monitor. Voltage Detection Circuit Detects the output voltage of every part in detection circuit, converts analogue signals to digital signals and then send them to main control board for processing.

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M3A Vital Signs Monitor Service Manual

Test and Maintenance

Chapter 6 Test and Maintenance 6.1 Maintenance Inspection To ensure the accuracy of the monitoring data, you should routinely check the monitor before usage. Firstly, check appearance and installation of the monitor. And make sure that:  Check the monitor and accessories to see if there is any visible damage that may affect patient’s safety.  Check all the outer cables, power socket and power cables.  Check if the monitor functions properly to make sure it is in good condition. If any damage is detected, replace the damage part (s) or contact EDAN immediately.

Routine Inspection The overall check of the monitor, including the safety check and functions check, should be performed by qualified personnel once every 6 to 12 months, and each time after service. You should do periodic safety test to insure proper patient isolation from leakage currents. This should include leakage current measurement and insulation testing. The recommended testing interval is once a year or as specified in the institution’s test and inspection protocol.

Mechanical Inspection  Make sure all exposed screws are tightly fixed.  Check the external cables for splits, cracks or signs of twisting.  Pay particular attention to the supply socket. Replace any cable that shows serious damage. WARNING If the hospital or agency does not follow a satisfactory maintenance schedule when using monitor, the monitor may become invalid, and the human health may be endangered.

6.2 Maintenance of the Monitor Keep the exterior surface of the monitor clean, free of dust and dirt. The gathering of dew in the screen may occur with abrupt temperature or humidity changes. A table environment is recommended.

6.3 Maintenance of Sensors Keep the sensors in a dry environment with the temperature lower than +45°C (+113°F). Handle the sensors with care. Rough handling could damage the cover, piezoelectric crystals and - 26 -

M3A Vital Signs Monitor Service Manual

Test and Maintenance

mechanical movement. Contacting the transducers with hard or sharp objects should be avoided. Do not excessively flex the cables.

6.4 NIBP Calibration It is recommended that user should calibrate monitor after it works for a long period, in case the measuring results are inaccurate. The calibration should be executed by professional personnel authorized by EDAN. NOTE: The calibration of NIBP is just a method for checking the measuring results, it will not change the measuring standard. NIBP Calibration needs T-connector, hose and Thermometer. Calibration procedure: 1 Connect air way as indicated in figure 6-1;

T-connector Thermometer

Monitor

Figure 6-1 NIBP calibration

2 Press the Menu button to open the Main Menu, Select NIBP Setup > Calibrate, as shown in the following menu:

Figure 6-2 NIBP Calibrate

3 Fill air into system, observe real-time pressure value and displayed pressure value in Thermometer. If the two values are equal, we can consider NIBP measuring of monitor has no failure. - 27 -

M3A Vital Signs Monitor Service Manual

Troubleshooting

Chapter 7 Troubleshooting In transportation, storage and use of monitor, various factors such as unstable network voltage, changing environmental temperature, falling-down or impact, component aging may all result in monitor failures and therefore affect normal application of the device. In failure conditions, professional personnel with the experience of repairing electronic medical devices should perform component-level upkeep for the failure classification listed in the table below. Component-level upkeep means based on analyzing, replacing or trial-operating the component, we can pinpoint the failure on a certain component of the device, such as power board, main control board, LCD assembly, measuring cable or parameter module, etc. Repair of only some components means component-level repair. The repair operation must be conducted by a service engineer with abundant experience and with the assistance of special equipment and in specific environment and conditions.

7.1 Monitor Booting Failure Phenomenon

Possible Cause

Solution

After switching on, LCD ① Fuse damage (If it has fuse ① Replace fuse has no display; the power on) ② Replace power board indicator is off. ② Power board damage ③ Anchor the short-circuited ③ Component short-circuits. component. No display after power-on Main control board failure or Refer to section 7.2 Display or black screen during display failure. Failure. operation, however, power indicator lights. Operation or Main control measurement function is corresponding disabled. damage. Device stoned.

is

board or Examine the main control component board and the corresponding components.

occasionally ① Moment intensive ① Check power supply and interference of network. grounding system. ② Poor performance of power ② board. ③ ③ Poor performance of main control board. ④ ④ Bad connection of power supply or main control board.

- 28 -

Replace power board. Replace board.

main

Replace or connectors.

control repair

M3A Vital Signs Monitor Service Manual

Troubleshooting

7.2 Display Failure Phenomenon

Possible Cause

Solution

Characters are displayed Data communication error Replace the main control normally, however between main control board and board or parameter module waveforms are displayed parameter module. based on the error prompt. intermittently. When powering on the ① The wire for connecting ① Repair or replace device, power supply is in display screen is damaged. connecting wire. normal operation, however, ② Damage of main control board. ② Replace main control there is no display or the board. screen goes black during ③ Damage of power board. ③ Replace power board. normal operation. LCD displays character.

improper

LCD screen has failure.

Replace the LCD screen.

7.3 Operation Failure Phenomenon

Possible Cause

Buttons or the rotary Main control board has failure. knob is disabled.

Solution Replace buttons or main control board.

Sound of speaker is ① Audio part of main control ① Replace main control board. raucous or there is no board has failure. ② Replace speaker or connecting sound. ② Speaker or connecting wire wire. has failure.

7.4 Network Failure Phenomenon ① The monitor can not be linked to the ② network. ③

Possible Cause

Solution

Network linking wire is ① Check and repair network linking damaged wire. Network bed NO. conflicts

② Change bed NO.

Main control board failure

③ Replace main control board

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M3A Vital Signs Monitor Service Manual

Troubleshooting

7.5 Power Board Failure Phenomenon

Possible Cause

Solution

Fuse is burned upon power-on.

Short circuit occurs in power supply or other parts.

Check after power on the monitor.

Fuse is burned although all loads are disconnected.

Power board failure.

Replace power board.

Fuse is burned after connecting a part.

Short circuit occurs in this part.

Replace this part.

7.6 Alarm Failure Phenomenon No audible activated.

alarm

Possible Cause is

① Audio alarm temporarily disabled. ② Speaker connecting failure.

and wire

Solution is its has

① Switch on the audible alarm. ② Replace the speaker or the wire.

The alarm indicator stays off.

Alarm indicator has failure.

Replace the alarm indicator; if there is no alarm indicator for replacing, change main control board.

No audible alarm or visual alarm is activated.

Program failure

Update the software.

7.7 Parameter Failure Phenomenon

Possible Cause

Solution

NIBP function of X2 ① The connection of X2 ① Check the connection module communication module and main control between boards. stops. board has failure. ② Replace X2 module. ② NIBP function of X2 module ③ Replace main control board. has failure. ③ Main control failure.

board

- 30 -

has

M3A Vital Signs Monitor Service Manual

Troubleshooting

NIBP cuff can not be Airway is folded or has leakage. inflated.

Adjust or repair the airway.

Blood pressure can not Cuff becomes loose or patient is Keep the patient quiet, bind the be measured moving. cuff correctly and safely. occasionally. Error of NIBP ① Cuff size does not fit the ① Use the cuff of appropriate measurement is too big. patient. size. ② X2 module performance.

has

bad ② Replace NIBP module.

the connection SpO2 function of X2 ① The connection of X2 ① Check between boards. module communication module and main control stops. board has failure. ② Replace X2 module. ② SpO2 function of X2 module ③ Replace main control board. has failure. ③ Main control failure. No SpO2 waveform

board

has

Sensor or SpO2 module is Replace the sensor. damaged.

SpO2 waveform has ① Patient is moving. ① Keep the patient quiet. strong interference. ② Environment light is very ② Weaken the light intensity in intensive. the environment. SpO2 value is inaccurate Coloring agent has been injected Remove the coloring agent before into patient body. measurement. No TEMP value

① TEMP sensor has failure.

① Replace the TEMP sensor.

② The connection of TEMP ② Check the connection. sensor has failure. ③ Replace the T2 module. ③ T2 module has failure.

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M3A Vital Signs Monitor Service Manual

Modules’ Malfunction Verification

Chapter 8 Modules’ Malfunction Verification When a module is suspected of malfunction, verify it using the method described in this chapter. NOTE: 1 For all the interfaces, the first pin is the one with a square solder pad. 2 Before switching on the monitor, Please make sure the fuse has been installed in the monitor.

8.1 To Verify Malfunction of the Main Control Board To verify the main control board in the following procedure: 1) Open the main unit using the procedures described in section 9.3 Disassembling the Main Unit. 2) Switch on the monitor. (Powered by AC or battery.) 3) Using a multimeter, measure the voltage to earth of the pins listed below. NO.

Pin

Reference result

1

C17 positive pole

(+5 ±5%) V

2

C18 positive pole

(+12 ±5%) V

3

TP5

(+3.3 ±5%) V

4

TP6

(+1.8 ±5%) V

5

TP2

+23.7 V ~ +26.5 V (without LCD screen)

6

TP2

(+20±10%) V (with LCD screen)

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M3A Vital Signs Monitor Service Manual

Modules’ Malfunction Verification

C17 positive pole C18 positive pole

TP2

TP5

C17 TP2

TP6

C18

TP5 Figure 8-1 Main control board - 33 -

M3A Vital Signs Monitor Service Manual

Modules’ Malfunction Verification

8.2 To Verify Malfunction of the Network Board To verify the network board in the following procedure: 1) Open the main unit using the procedures described in section 9.3 Disassembling the Main Unit. 2) Switch on the monitor. (Powered by AC or battery.) 3) Using a multimeter, measure the voltage to earth of the pins listed below. NO.

Pin

Reference result

1

D1 cathode

(+12±5%) V

2

C6 positive pole

(+3.3 ±5%) V

C6 positive pole

D1 cathode

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M3A Vital Signs Monitor Service Manual

Modules’ Malfunction Verification

C6 positive pole

D1 cathode

Figure 8-2 Network interface board

8.3 To Verify Malfunction of the X2 Module To verify the X2 module in the following procedure: 1) Make sure the NIBP measuring failure is not caused by malfunction of connection, cuff, extensive tube or main control board, etc. 2) Open the main unit using the procedures described in section 9.3 Disassembling the Main Unit. 3) Disconnect the X2 connector from the interface board. 4) Switch on the monitor. (Powered by AC or battery.) 5) Using a multimeter, measure the voltage to earth of the pins listed below. NO.

Pin

Reference result

1

2nd pin of J2

(+5 ±5%) V

2

3rd pin of J2

(+12 ±5%) V

3

5th pin of J2

RXD

4

6th pin of J2

TXD

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M3A Vital Signs Monitor Service Manual

Modules’ Malfunction Verification

6) Use an oscillograph to measure the 1st pin of J9. A +0V ~ +5V pulse string signal should be detected. 7) If all the results are in the reference range, reconnect the X2 cable and measure the voltage to earth of the following pins on the X2 board. NO.

Pin

Reference result

1

2nd pin of J2

(+5±5%) V

2

3rd pin of J2

(+12±5%) V

3

5th pin of J2

Serial port signal with 115200bps baud rate

4

6th pin of J2

Serial port signal with 115200bps baud rate

J2

Figure 8-3 X2 module

8) If any one of the results is out of the reference range, the X2 module failure is confirmed. Replace the X2 module as recommended.

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M3A Vital Signs Monitor Service Manual

Modules’ Malfunction Verification

8.4 To Verify Malfunction of the T2 Module To verify the T2 module in the following procedure: 1) Make sure the TEMP measuring failure is not caused by malfunction of connection, sensor or main control board, etc. 2) Open the main unit according to the procedures described in section 9.3 Disassembling the Main Unit. 3) Disconnect the T2 module described in section 9.4.1 Replacing T2 Module, overturn the module to see the test points in another part. 4) Switch on the monitor. (Powered by AC or battery.) 5) Using a multimeter, measure the voltage to earth of the pins listed below. NO.

Test point

Minimum

Maximum

1

T11

+5 V

+8 V

2

T2

+3.2 V

+3.4 V

3

T38

+3.2 V

+3.4 V

4

T17

+2.4 V

+2.55 V

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M3A Vital Signs Monitor Service Manual

Modules’ Malfunction Verification

T17 T11 T38

T2

Figure 8-4 T2 module

6) If any one of the results is out of the reference range, the T2 module failure is confirmed. Replace the T2 module as recommended.

8.5 To Verify Malfunction of the Power Module To verify the power module in the following procedure: 1) Open the main unit as described in section 9.3 Disassembling the Main Unit. 2) Disconnect switch connector, communication connector and power output connector of power module from J4, J2 and J9 pin. 3) Switch on the monitor. 4) Short-circuit J4 pin for 1s. - 38 -

M3A Vital Signs Monitor Service Manual

Modules’ Malfunction Verification

5) Using a multimeter, measure the voltage to earth of the pins listed below. NO.

J4

J2

Pin

Reference result

1

1st pin of J9

(+12±5%) V

2

2nd pin of J9

(+5±5%) V

J9

Figure 8-5 Power module

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

Chapter 9 Disassembling the Monitor WARNING 1 Only qualified service personnel can open the monitor case. 2 Switch off the monitor and remove the AC power cable before disassembling the monitor. 3 After any repair of the monitor, perform safety tests before using the monitor again.

9.1 Tools Required A cross-head screwdriver

A flat-head screwdriver

An M3 nut driver

A pair of pliers

Figure 9-1 Tools required

9.2 Replacing Fuses To replace the blown fuse in the following procedure: 1) Switch off the monitor and unplug it. 2) Carefully place the monitor upside down on a flat surface covered with cloth or other protecting pad. 3) Place a flat-head screw driver in the gap of the fuse. Apply a certain amount of pressure on the screw driver to sink the fuse for about 1 mm. Unscrew the fuse anticlockwise.

- 40 -

M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

Figure 9-2 Remove the old fuse

4) Remove the old fuse. Take out a new fuse supplied by EDAN or of the same specification: Size: Ф5mm×20mm; Model: T1.6AL 250V. 5) Place the new fuse in the fuse socket. Press and screw it clockwise back in position.

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

9.3 Disassembling the Main Unit 9.3.1 Separating Front Panel and Rear Panel 1 Remove the four screws in rear panel with screwdriver to separate the front panel and rear panel.

M3×25 cross recessed pan head screw

Figure 9-3 Remove screws

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

2 Take apart the front panel and rear panel at the joint, then disconnect the cables and connectors to separate the two parts.

①

② ③

①

Cable between speaker and main control board

②

Cable for nurse call

③

Cable between main control board and network board Figure 9-4 Left side of monitor

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

①

② ③

④ ⑤

①

Connector for power cable between main control board and PS900K.

②

Connector for control connecting cable between main control board and PS900K.

③

Connector between main control board and X2 module.

④

NIBP airway tube connector.

⑤

SpO2 sensor connector. Figure 9-5 Right side of monitor

9.3.2 Taking out the Main Bracket 1 To separate the rear panel, firstly, you should overturn the monitor and remove the fuses as described in section 9.2 Replacing Fuses. Then remove three screws for fixing main bracket and rear panel.

- 44 -

M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

M3×6 cross recessed countersunk head screw

Fuses

Figure 9-6 Screws on rear panel

2 Remove four screws in main bracket and one screw for grounding. Then carefully take out the main bracket from rear bracket.

- 45 -

M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

M3×6 cross recessed pan head screw

M3×6 cross recessed pan head screw

Figure 9-7 Remove screws from main bracket - 46 -

M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

Figure 9-8 Take out main bracket

9.4 Disassembling Rear Panel Assembly 9.4.1 Replacing T2 Module To replace T2 module, you should remove it according to the following procedure: 1. Separate front panel and rear panel assemblies according to section 9.3.1 Separating Front Panel and Rear Panel. 2. Remove two screws for fixing T2 module on rear panel. 3. Remove connecting cable between T2 module and main control board, pull the cable out from the hole in rear panel.

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

4. Slide out the block on T2 module bracket, and then uninstall the bracket from monitor. Take care of the block when uninstalling as the following figure shows:

Screws

Block

Connecting cable for T2 module and Main control board

Block

Figure 9-9 Remove T2 Module - 48 -

M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

5. Remove four screws on T2 module, and then separate the module.

Screws

Figure 9-10 T2 module

To replace the T2 module: Install a new T2 module in a reverse procedure.

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

9.4.2 Replacing X2 Module To replace X2 module, you should remove it according to the following procedure: 1. Separate front panel and rear panel assemblies according to section 9.3.1 Separating Front Panel and Rear Panel. 2. Remove four screws for fixing X2 module on Rear panel. 3. Remove connecting cable, and then remove X2 module.

Screws

Figure 9-11 X2 module

To replace the X2 module: Install a new X2 module in a reverse procedure.

9.4.3 Replacing Power Module To replace power module, you should remove it according to the following procedure: 1. Separate front panel and rear panel assemblies, and take out main bracket as described in section 9.3 Disassembling the Main Unit. 2. Remove four screws for fixing power module on main bracket as the following figure shows:

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

Screws

Figure 9-12 Power module

To replace the power module: Install a new power module in a reverse procedure.

9.4.4 Replacing Network Module To replace network board in the following procedure: 1. Separate front panel and rear panel assemblies, and take out main bracket as described in section 9.3 Disassembling the Main Unit.

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

2. Remove three screws for fixing network module and the interface cable, and then remove the network module.

Cross recessed pan head screw

Figure 9-13 Screws on LCD screen

To replace the network module: Install a new network module in a reverse procedure.

9.4.5 Replacing Speaker To replace the speaker in the following procedure: 1. Separate front panel and rear panel assemblies, and take out main bracket as described in section 9.3 Disassembling the Main Unit. 2. The speaker is on rear panel. Remove two screws for fixing speaker, and then remove the speaker.

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

Speaker

Figure 9-14 Screws on LCD screen

To replace the speaker: Install a new speaker in a reverse procedure.

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

9.5 Disassembling Front Panel Assembly 9.5.1 Replacing Main Control Board To replace main control board, you should remove it according to the following procedure: 1. Separate front panel and rear panel assemblies according to section 9.3.1 Separating Front Panel and Rear Panel. 2. Remove the connector for LCD screen: open the clock on the connector, and then remove the connector of LCD screen from FPC interface.

Clock

Figure 9-15 Connector for LCD screen

- 54 -

M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

3. After taking off the connector for LCD screen, remove six screws for fixing module, and then remove the main control board.

M3×8 cross recessed screw

Figure 9-16 Screws on module

To replace the main control board: Install a new main control board in a reverse procedure.

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M3A Vital Signs Monitor Service Manual

Disassembling the Monitor

9.5.2 Replacing LCD Screen To replace LCD screen, you should remove it according to the following procedure: 1. Separate front panel and rear panel assemblies according to section 9.3.1 Separating Front Panel and Rear Panel. 2. Remove the connector for LCD screen: open the clock on the connector, and then remove the connector of LCD screen from FPC interface.

Clock

Figure 9-17 Connector for LCD screen

3. Remove four screws for fixing LCD screen, one of them is grounded.

M3×8 screws

Grounding Figure 9-18 Screws on LCD screen

To replace the LCD screen: Install a new LCD screen in a reverse procedure. - 56 -

M3A Vital Signs Monitor Service Manual

Renewal Parts

Chapter 10 Renewal Parts WARNING The specifications of recommended accessories are listed below. Using other accessories may damage the monitor. The following accessories are recommended when using this monitor. Standard configuration including: Part Number

Accessories

12.01.109069

EDAN SH1 Adult Reusable SpO2 Sensor (Only compatible with EDAN SpO2 module)

01.57.40029

Adult NIBP cuff / (25cm ~ 35cm), CM1203, with sensor 190

01.57.471005

NIBP cuff extension tube /3m, TPU

01.13.36014

Power supply cable 220V (EUR Standard)

11.13.36015

Power supply cable (USA Standard)

01.21.064115

Rechargeable Lithium-Ion Battery HYLB-1049 (14.8V/4.4 Ah, optional)

01.21.064147

Rechargeable Lithium-Ion Battery /HYLB-1264 (14.8V/2.2 Ah)

11.13.114214

Grounding line

Optional configuration including: EDAN SpO2 12.01.109069

EDAN SH1 Adult Reusable SpO2 Sensor (Only compatible with EDAN SpO2 module)

12.01.109079

EDAN SH1 Adult Reusable SpO2 Finger Sensor (DB9), 1m

01.13.210001

EDAN SpO2 extension cable

12.01.110492

EDAN SH3 Neonatal SpO2 Sensor (Only compatible with EDAN SpO2 module and extension cable)

12.01.110515

EDAN SH4 Adult Silicone Soft-tip SpO2 Sensor (Only compatible with EDAN SpO2 module and extension cable)

02.01.110531

EDAN SH4 Adult Silicone Soft-tip SpO2 Sensor (Immersion Disinfection)

12.01.110521

EDAN SH5 Child Silicone Soft-tip SpO2 Sensor

01.57.040196

Adult disposable SpO2 sensor/ SESI001B - 57 -

M3A Vital Signs Monitor Service Manual

Renewal Parts

01.57.040197

Pediatry disposable SpO2 sensor / SESJ001B

01.57.040198

Infant disposable SpO2 sensor / SELK001B

01.57.040199

Neonate disposable SpO2 sensor / SELL001B

NIBP 01.57.471005

NIBP cuff extension tube /3m, TPU

11.59.36029

Blood pressure airway tube / 6mm×4mm

11.59.30437

Neonate blood pressure cuff connecting tube

01.57.40020

Infant blood pressure cuff (10cm ~ 19cm), CM1201, with sensor 190

01.57.40018

Pediatry blood pressure cuff (18cm ~ 26cm), CM1202, with sensor 190

01.57.40029

Adult blood pressure cuff (25cm ~ 35cm), CM1203, with sensor 190

01.57.40074

Larger adult blood pressure cuff (33cm ~ 47cm), CM1204, with sensor 190

11.57.40097

Neonate disposable blood pressure cuff 5102 (6cm ~ 9 cm)

11.57.40098

Neonate disposable blood pressure cuff 5104 (9cm ~ 14cm)

01.57.040139

Infant blood pressure cuff SURGI-CUF 5101 (3cm ~ 6cm)

01.57.040140

Infant blood pressure cuff SURGI-CUF 5103 (8cm ~ 12cm)

01.57.040141

Infant blood pressure cuff SURGI-CUF 5104 (9cm ~ 14cm)

01.57.040142

Infant blood pressure cuff SURGI-CUF 5105 (12cm ~ 18cm)

Others 12.01.109480

Trolley

02.01.109481

Wall Mounting Bracket

02.01.109592

Pole Clamp/1 piece

02.01.109636

Pole Clamp/4 pieces

01.13.36014

Power supply cable 220V (EUR Standard)

11.13.36015

Power supply cable (USA Standard)

01.21.064115

Rechargeable Lithium-Ion Battery HYLB-1049 (14.8V/4.4 Ah,optional)

01.21.064147

Rechargeable Lithium-Ion Battery /HYLB-1264 (14.8V/2.2 Ah)

11.13.114214

Grounding line

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M3A Vital Signs Monitor Service Manual

Specification

Appendix 1 Specification A1.1 Classification Anti-electroshock type

ClassⅠequipment and internally powered equipment

EMC type

Group I Class A

Anti-electroshock degree

SpO2, NIBP: Type BF, defibrillation-proof TEMP: Type CF

Ingress protection

IPX1 (No protection against ingress of water if configured with TEMP module)

Working system

Continuous running equipment (no more than 7 days)

Compliant with safety standards

IEC 60601-1:1988+A1+A2, EN 60601-1:1990+A1+ A2, IEC/EN 60601-1-2:2001+A1, IEC 60601-1-8, ISO 9919, EN 1060-1, EN 1060-3, EN 1060-4, ANSI/AAMI SP10, IEC/EN 60601-2-30, IEC60601-2-49

A1.2 Specifications A1.2.1 Size and Weight Size

200.8 mm (L)×241 mm (H)×189 mm (D)

Weight

2.4 kg (without battery)

A1.2.2 Environment NOTE: When the monitor and related products have differing environmental specifications, the effective range for the combined products is that range which is common to the specifications for all products. Temperature Working

+5 C ~ +40 C

Transport and storage

-20 C ~ +55 C

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M3A Vital Signs Monitor Service Manual

Specification

Humidity Working

25% ~ 80% (no condensing)

Transport and storage

25% ~ 93% (no condensing)

Altitude Working

860hPa ~ 1060hPa

Transport and storage

700hPa ~ 1060hPa

Power supply

Voltage: 100V-240V ~ Frequency: 50Hz/60Hz Pmax: 70VA Battery: 14.8V/4.4 Ah; 14.8V/2.2 Ah.

A1.2.3 Display Multicolor LCD

Resolution: 320×240, adjustable brightness 1 PLETH waveform

Seven-segment display

Display NIBP/SpO2/TEMP measuring values & unit Patient type Pulse amplitude display TEMP measuring position

Messages

1 power supply indicator LED (Green) 1 power on indicator LED (Green) 1 alarm indicator LED (Cyan/Yellow/ Red) 1 alarm silence indicator LED (Yellow) 1 charge indicator LED (Yellow) 1 NIBP working status indicator LED (Backlight) 3 indicating modes correspond to alarm mode

NURSE CALL Drive mode

Relay

Electronic

≤1A, ≤125V ~, ≤110V DC - 60 -

M3A Vital Signs Monitor Service Manual

Specification

Isolated voltage

1500V ~ (line to ground)

Status

Continuously ON

A1.2.4 Battery Quantity

1

Type

Li battery

Power-off delay

5 min ~ 15 min (After the low battery alarm)

Voltage

14.8 VDC

Capacitance

2.2 Ah 4.4 Ah (optional)

Working period

2.2 Ah: 10 hours 4.4 Ah: 21 hours (At +25℃, continuous SpO2 measuring, automatic NIBP measuring per 15min)

Rechargeable period

2.2 Ah: 180 min 4.4 Ah: 320 min

A1.2.5 Review Trend list review

100 hours, 30 seconds Resolution

Measurement review

12, 000 groups of measuring data

A1.2.6 NIBP (Optional) Method

Oscillometric

Measuring type

Systolic Pressure, Diastolic Pressure, Mean Pressure, PR

Mode

Manual, Auto, Continuous

Measuring interval in AUTO mode

1/2/3/4/5/10/15/30/60/90/120/240/480 min

Continuous

5 min, interval is 5 s

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M3A Vital Signs Monitor Service Manual

Specification

Typical measuring period

30 s ~ 45 s (depend on HR/motion disturbance)

Calibration

Every 30 s (In standby mode)

Measuring range ADU mode

SYS 40 mmHg ~ 270 mmHg DIA 10 mmHg ~ 215 mmHg MAP 20 mmHg ~ 235 mmHg

PED mode

SYS 40 mmHg ~ 200 mmHg DIA 10 mmHg ~ 150 mmHg MAP 20 mmHg ~ 165 mmHg

NEO mode

SYS 40 mmHg ~ 135 mmHg DIA 10 mmHg ~ 100 mmHg MAP 20 mmHg ~ 110 mmHg

Alarm type

SYS, DIA, MAP

Cuff pressure measuring range

0 mmHg ~ 290 mmHg

Pressure resolution

1 mmHg

Maximum mean error

±5 mmHg

Maximum standard deviation

±8 mmHg

Overpressure protection

ADU (297±3) mmHg

(Dual overpressure protection)

PED

(240±3) mmHg

NEO (145±3) mmHg PR Measuring range

40 bpm ~ 240 bpm

Resolution

1 bpm

Accuracy

The maximum of ±3 bpm or 3.5 %

A1.2.7 SpO2 (Optional) Measuring range

0% ~ 100 %

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M3A Vital Signs Monitor Service Manual

Specification

Alarm range

0% ~ 100 %

Resolution

1%

Accuracy ADU & PED

2 digits (70% ~ 100% SpO2) Undefined (0% ~ 70% SpO2)

NEO

3 digits (70% ~ 100% SpO2) Undefined (0% ~ 70% SpO2)

Pulse rate Measuring and alarm range

30 bpm ~ 254 bpm

Resolution

1 bpm

Accuracy

 3 bpm

Data update period

2s

A1.2.8 TEMP (Optional) Environment temperature for working

+10 C ~ +40 C

Measuring range

+25 C ~ +45 C

Sensor type

Oral/Axillary, Rectal

Alarm range

+25 C ~ +45 C

Resolution

+0.1 C

Accuracy

0.1 C (+25 C ~ +45 C)

Response time

< 60 s

Update time

1s~2s

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