Mindray DPM4 User manual

For this Service Manual, the issued date is May 2010 (Version: 3.0).

Intellectual Property Statement

Mindray DS USA, Inc. (hereinafter called Mindray DS) owns the intellectual property rights to

this product and this manual. This manual may refer to information protected by copyrights or

patents and does not convey any license under the copyright and patent rights of Mindray DS, nor

the rights of others.

Mindray DS intends to maintain the contents of this manual as confidential information.

Disclosure of the information in this manual in any manner whatsoever without the written

permission of Mindray DS is strictly forbidden. Release, amendment, reproduction, distribution,

rental, adaptation and translation of this manual in any manner whatsoever without the written

permission of Mindray DS is strictly forbidden.

is a trademark or a registered trademark of Shenzhen Mindray Bio-Medical

Electronics Co., Ltd. All third-party trademarks that appear in this manual are used solely for

editorial purposes and are the property of their respective owners.

Contents of this manual are subject to changes without prior notice.

Responsibility on the Manufacturer Party

All information contained in this manual is believed to be correct. Mindray DS shall not be liable

for errors contained herein nor for incidental or consequential damages in connection with the

furnishing or use of this manual.

Mindray will not be liable for the effects on safety, reliability and performance of this product if:

 any installation operations, expansions, changes, modifications and repairs of this product are

not conducted by Mindray DS authorized personnel; and

 the electrical installation of the relevant room does not comply with the applicable national

and local requirements; and

 the product is not used in accordance with the instructions for use.

Upon request, Mindray DS may provide, with compensation, necessary circuit diagrams,

calibration illustration list and other information to help qualified technician to maintain and

repair some parts, which Mindray DS may define as user serviceable.

NOTE

z This equipment must be operated by skilled/trained medical professionals.

WARNING

For continued safe use of this equipment, it is necessary that the listed instructions

are followed. However, instructions listed in this manual in no way supersede

established medical practices concerning patient care

z Do not rely only on audible alarm system to monitor patient. When monitoring

adjusting the volume to very low or completely muting the sound may result in

the disaster to the patient. The most reliable way of monitoring the patient is at

the same time of using monitoring equipment correctly, manual monitoring

should be carried out.

z This multi-parameter patient monitor is intended for use only by medical

professionals in health care institutions.

z To avoid electrical shock, you shall not open any cover by yourself. Service must

be carried out by qualified personnel.

z Use of this device may affect ultrasonic imaging system in the presence of the

interfering signal on the screen of ultrasonic imaging system. Keep the distance

between the monitor and the ultrasonic imaging system as far as possible.

z It is dangerous to expose electrical contact or applicant coupler to normal saline,

other liquid or conductive adhesive. Electrical contact and coupler such as cable

connector, power supply and parameter module socket-inlet and frame must be

kept clean and dry. Once being polluted by liquid, they must be thoroughly

dried. If to further remove the pollution, please contact your biomedical

department or Mindray DS.

It is important for the hospital or organization that employs this equipment to carry out a

reasonable maintenance schedule. Neglect of this may result in machine breakdown or injury of

human health.

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR

FITNESS FOR ANY PARTICULAR PURPOSE.

III

Exemptions

Mindray DS 's obligation or liability under this warranty does not include any transportation or

other charges or liability for direct, indirect or consequential damages or delay resulting from the

improper use or application of the product or the use of parts or accessories not approved by

Mindray DS or repairs by people other than Mindray DS authorized personnel.

This warranty shall not extend to:

 any Mindray DS product which has been subjected to misuse, negligence or accident;  any Mindray DS product from which Mindray DS's original serial number tag or product

identification markings have been altered or removed;

 any product of any other manufacturer.

Safety, Reliability and Performance

Mindray DS is not responsible for the effects on safety, reliability and performance of DPM4

patient monitor if:

 Assembly operations, extensions, re-adjusts, modifications or repairs are carried out by

persons other than those authorized by Mindray DS.

 Personnel unauthorized by Mindray DS repairs or modifies the instrument.

Return Policy

Return Procedure

In the event that it becomes necessary to return this product or part of this product to Mindray DS,

the following procedure should be followed:

1. Return authorization: Contact the Customer Service Department and obtain a Customer

Service Authorization number. This number must appear on the outside of the shipping

container. Returned shipments will not be accepted if the number is not clearly visible.

Please provide the model number, serial number, and a brief description of the reason for

return.

2. Freight policy: The customer is responsible for freight charges when this product is shipped

to Mindray DS for service (this includes customs charges).

3. Return address: Please send the part(s) or equipment to the address offered by the Customer

Service department

Company Contact

Manufacturer: Mindray DS USA, Inc.

Address: 800 MacArthur Blvd. Mahwah, New Jersey 07430 USA

Tel: 1.800.288.2121 1.201.995.8000

Website: www. mindray.com

Safety Precautions

1. Meaning of Signal Words

In this service manual, the signal words

indicate safety and other important instructions The signal words and their meanings are defined

as follows.

Signal word Meaning

Indicates a potentially hazardous situation which, if not avoided, could

WARNING

CAUTION

NOTE

2. Meaning of Safety Symbols

Symbol Description

result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may

result in minor or moderate injury.

Indicates a potentially hazardous situation which, if not avoided, may

result in property damage.

Type-BF applied part

WA R NI N G, CAUTION and NOTE are used to

"Attention" (Refer to the operation manual.)

Safety Precautions

Please observe the following precautions to ensure patient and operator safety when using this

system.

WARNING

z Do not connect this system to outlets with the same circuit breakers and fuses

that control current to devices such as life-support systems. If this system

malfunctions and generates an overcurrent, or when there is an instantaneous

current at power ON, the circuit breakers and fuses of the building’s supply

circuit may be tripped.

z Do not use flammable gasses such as anesthetics, or flammable liquids such as

ethanol, near this product, because there is danger of explosion.

CAUTION

1. Malfunctions due to radio waves

z Use of radio-wave-emitting devices near the monitor may interfere with its

operation. Do not bring or use devices which generate radio waves, such as

cellular telephones, transceivers, and radio controlled toys, in the room where

the system is installed.

z If a user brings a device which generates radio waves near the system, they

must be instructed to immediately turn OFF the device. This is necessary to

ensure the proper operation of the system.

2. Do not allow fluids such as water to contact the system or peripheral devices.

Electric shock may result.

Symbols

See instructions Protective earth ground

Indicates that the instrument is IEC-60601-1 Type CF 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.

Equipotential grounding terminal

VII

FOR YOUR NOTES

VIII

Contents

1 About the Product ............................................................................................................ 1-1

1.1 Introduction..................................................................................................................... 1-1

1.2 Application...................................................................................................................... 1-1

1.2.1 General ............................................................................................................... 1-1

1.2.2 Usage.................................................................................................................. 1-2

2 Principles........................................................................................................................... 2-1

2.1 General............................................................................................................................ 2-1

2.1.1 Parameter Measurement..................................................................................... 2-2

2.1.2 Main Control Part............................................................................................... 2-2

2.1.3 Man-Machine Interface...................................................................................... 2-2

2.1.4 Power Supply ..................................................................................................... 2-3

2.1.5 Other Auxiliary Functions.................................................................................. 2-3

2.2 Hardware Description ..................................................................................................... 2-3

2.2.1 Main Board......................................................................................................... 2-4

2.2.2 ECG/RESP/TEMP Module................................................................................ 2-6

2.2.3 IBP Module ........................................................................................................ 2-9

2.2.4 SpO2 Module.....................................................................................................2-11

2.2.5 NIBP Module ................................................................................................... 2-13

2.2.6 Recorder Module.............................................................................................. 2-15

2.2.7 Button Panel..................................................................................................... 2-16

2.2.8 Power PCB....................................................................................................... 2-17

2.3 Software Description..................................................................................................... 2-19

2.3.1 General ............................................................................................................. 2-19

2.3.2 System Task...................................................................................................... 2-20

2.3.3 System Function............................................................................................... 2-21

2.4 System Parameter.......................................................................................................... 2-22

2.4.1 General ............................................................................................................. 2-22

2.4.2 ECG/RESP ....................................................................................................... 2-23

2.4.3 NIBP................................................................................................................. 2-24

2.4.4 SpO2................................................................................................................. 2-25

2.4.5 TEMP ............................................................................................................... 2-25

2.4.6 IBP ................................................................................................................... 2-26

2.4.7 CO2 .................................................................................................................. 2-26

3 Product Specification....................................................................................................... 3-1

3.1 Safety Classifications......................................................................................................3-1

3.2 Environmental Specifications ......................................................................................... 3-1

3.3 Power Source Specifications........................................................................................... 3-2

3.4 Hardware Specifications ................................................................................................. 3-3

3.5 Wireless network............................................................................................................. 3-4

3.6 Data Storage.................................................................................................................... 3-4

3.7 Signal Output Specifications........................................................................................... 3-4

3.8 ECG Specifications ......................................................................................................... 3-5

3.9 RESP Specifications...................................................................................................... 3-12

3.10 SpO2 Specifications..................................................................................................... 3-13

3.11 NIBP Specifications .................................................................................................... 3-15

3.12 TEMP Specifications................................................................................................... 3-16

3.13 IBP Specifications....................................................................................................... 3-17

3.14 CO2 Specifications ...................................................................................................... 3-18

4 Disassembling/Assembling & Troubleshooting.............................................................. 4-1

4.1 DPM4 Disassembling/Assembling ................................................................................. 4-1

4.1.1 Exploded View of DPM4 ................................................................................... 4-1

4.1.2 DPM4 Front Bezel Assembly............................................................................. 4-2

4.1.3 DPM4 Back Housing Assembly (Lithium Battery)............................................ 4-4

4.1.4 Screen Assembly ................................................................................................ 4-5

4.1.5 Battery Connector Assembly.............................................................................. 4-6

4.1.6 Parameter Connector Assembly ......................................................................... 4-7

4.1.7 CF Card Assembly ............................................................................................. 4-8

4.2 Troubleshooting .............................................................................................................. 4-9

4.2.1 4.2.1 Black Screen, Startup Failure.................................................................... 4-9

4.2.2 White Screen & Other Abnormal Screen ......................................................... 4-10

4.2.3 Encoder Faults.................................................................................................. 4-10

4.2.4 No Audio Alarm ............................................................................................... 4-10

4.2.5 Printing Failure................................................................................................. 4-10

4.2.6 Abnormal Paper Drive...................................................................................... 4-10

5 Test and Material List...................................................................................................... 5-1

5.1 Test Procedure ................................................................................................................. 5-1

5.1.1 5.1.1 Connection and Checking ......................................................................... 5-1

5.1.2 5.1.2 Functions of Buttons ................................................................................. 5-1

5.1.3 ECG/RESP ......................................................................................................... 5-1

5.1.4 Temperature........................................................................................................ 5-2

5.1.5 NIBP................................................................................................................... 5-2

5.1.6 SpO2................................................................................................................... 5-3

5.1.7 IBP ..................................................................................................................... 5-3

5.1.8 CO2 .................................................................................................................... 5-4

5.1.9 Watertrap ............................................................................................................ 5-4

5.1.10 Recorder ........................................................................................................... 5-5

5.1.11 Power Supply ................................................................................................... 5-5

5.1.12 Clock ................................................................................................................ 5-5

5.1.13 System Test ...................................................................................................... 5-5

5.2 NIBP Calibration............................................................................................................. 5-6

5.3 IBP Calibration................................................................................................................ 5-7

5.3.1 IBP Transducer Zero .......................................................................................... 5-7

5.4 DPM4 Material List .......................................................................................................5-11

6 Maintenance and Cleaning.............................................................................................. 6-1

6.1 Maintenance .................................................................................................................... 6-1

6.1.1 Checking Before Using ...................................................................................... 6-1

6.1.2 Regular Checking............................................................................................... 6-1

6.2 Cleaning .......................................................................................................................... 6-2

6.3 Cleaning Reagent ............................................................................................................6-2

6.4 Disinfection..................................................................................................................... 6-2

FOR YOUR NOTES

1 About the Product

1.1 Introduction

The DPM4 Patient Monitor, a portable and accessible patient monitor, which applies to adults,

pediatric and neonates, is supplied by rechargeable battery or external AC power. You can select

different configurations as required. Besides, the DPM4 can be connected with the central

monitoring system whereby a monitoring network will be formed. Parameters that the DPM4 can

monitor include: ECG, RESP, SpO

compact and lightweight patient monitor. Its color TFT LCD is able to show patient parameters

and waveforms clearly. The compact control panel and knob control, and the easy-to-use menu

system enable you to freeze, record, or perform other operations conveniently.

The DPM4 Patient Monitor measures patient’s ECG, NIBP, SpO

physiological signals through the ECG electrode, SpO

pressure transducer. During the measurement, the patient monitor does not get energy or any

substance from the human body, and does not release any substance to the human body. However,

it releases sine wave signals to the patient when measuring the respiration rate. The patient

monitor converts the measured physiological signals to the digital signals, waveforms and values,

and then displays them on the screen. You can control the patient monitor through the control

panel. For example, you can set different alarm limits for different patients. Thus, when the

patient monitor detects any physiological parameter exceeding the preset alarm limit, it will

enable the audio and visual alarm.

, NIBP, 2-channel TEMP, 2-channel IBP, and CO2. It is a

, TEMP, RESP, IBP, and CO2

sensor, cuff, temperature sensor and

1.2 Application

1.2.1 General

In the treatment processes, it is necessary to monitor important physiological information of

patients. Therefore, the patient monitor has been playing an outstanding role among medical

devices. The development of technology does not only help medical staff get the important

physiological information, but also simplifies the procedures and makes it more effective. For

patients in hospital, the basic and important physiological information is required, including ECG,

SpO2, RESP, IBP, CO2, TEMP, etc. In recent years, the development of science and technology

helping measure and get important physiological information of patients has made the patient

monitor more comprehensive in performance and better in quality. Today, multi-parameter patient

monitors are widely used.

1-1

1.2.2 Usage

DPM4 converts physiological signals to digital signals, processes them and displays them on the

screen. You can set the alarm limit as required. When the monitored parameter exceeds the preset

alarm limit, the patient monitor will start the alarm function. In addition, you can control the

patient monitor through the control panel. The DPM4 patient monitor should be run under the

control of clinical staff.

DPM4 patient monitor has the following functions:

ECG

Heart Rate (HR)

2-channel ECG waveform

Arrhythmia analysis and S-T analysis (optional)

Respiration Rate (RR) RESP

Respiration waveform

Pulse Oxygen Saturation (SpO

Plethysmogram

SpO

), Pulse Rate (PR) SpO2

NIBP Systolic pressure (NS), diastolic pressure (ND), mean pressure

(NM)

TEMP T1, T2, TD

IBP CH1: SYS, DIA

CH2: SYS, DIA

IBP waveform

End-tidal carbon dioxide (EtCO2)

Inspired minimum CO

(InsCO2)

Airway Respiration Rate (AwRR)

The DPM4 provides the functions of audio/visual alarm, trend graphic storage and output, NIBP

measurement, alarm event identification, large font screen, defibrillator synchronization,

oxyCRG recall, drug calculation, etc.

1-2

2 Principles

2.1 General

The intended use of the DPM4 patient monitor is to monitor a fixed set of parameters including

ECG, RESP, SpO2, NIBP, TEMP, IBP, and CO2 (IBP and CO2 are optional). It consists of the

following functional parts:

 Parameter measurement;  Main control part;  Man-machine interface;  Power supply;  Other auxiliary functions;

These functional units are respectively detailed below.

Figure 2-1 Structure of the DPM4

2-1

2.1.1 Parameter Measurement

The parameter measurement and monitoring are the core functions of the patient monitor. The

parameter measurement part of the DPM4 patient monitor consists of the measurement probe,

parameter input socket assembly, NIBP assembly and the main control board.

This part converts the physiological signals to electrical signals, processes those signals and

conducts the calculation by the preset program or command delivered from the main control

board, and then sends the values, waveforms and alarm information (which will be displayed by

using the man-machine interface) to the main control board.

2.1.2 Main Control Part

In the DPM4 patient monitor, the main control part refers to the main control part of the main

control board. It drives the man-machine interface, manages the parameter measurement and

provides users with other special functions, such as storage, recall of waveforms and data. (See

Figure 2-1)

2.1.3 Man-Machine Interface

The man-machine interface of the DPM4 patient monitor includes the TFT display, recorder,

speaker, indicator, buttons and control knob.

The TFT display is the main output interface. It, with the high resolution, provides users with

abundant real-time and history data and waveforms as well as various information and alarm

information.

The recorder is a subsidiary of the display, which is used for the user to print data.

The speaker provides the auditory alarm function.

The indicator provides additional information about the power supply, batteries, alarms and so

on.

The buttons and control knob are the input interface, which are used for the user to input the

information and commands to the patient monitor.

2-2

2.1.4 Power Supply

The power supply part is an important part of the patient monitor. It includes the main power

PCB, backlight board, batteries and fan.

The main power PCB converts the external AC current to the 5V DC current, which are supplied

for the whole system. For the TFT display, there is a special requirement on the power supply, so

a backlight board is used. The batteries supply power for the system for a short time when there is

no external AC current. The fan is used for the heat sink of the system.

2.1.5 Other Auxiliary Functions

The DPM4 patient monitor also provides the network upgrade function for the service engineers

to upgrade the system software without disassembling the enclosure.

2.2 Hardware Description

The structure of the DPM4 patient monitor is shown in the following figure.

Figure 2-2 Functional structure of the DPM4

2-3

The DPM4 PCB connection is shown in the following figure.

Figure 2-3 PCB connection

Basic functions and working principles of modules are described in the following sections.

2.2.1 Main Board

2.2.1.1 General

The main board is the heart of the patient monitor. It implements a series of tasks, including the

system control, system scheduling, system management, data processing, file management,

display processing, printing management, data storage, system diagnosis and alarm.

2-4

2.2.1.2 Principle diagram

Figure 2-4 Working principle of the main board

2.2.1.3 Principle

The main board is connected with external ports, including the power input port, multi-way serial

port, TFT display interface, analog VGA interface, network port and analog output port. Besides,

on the main board is also a BDM interface reserved for the software debugging and software

downloading.

CPU System

CPU is the core part of the main board. It, connected with other peripheral modules through the

bus and I/O cable, implements the data communication, data processing, logical control and other

functions.

RTC

RTC provides the calendar information (such as second, minute, hour, day, month and year). CPU

can read and modify the calendar information from RTC.

Ethernet Controller

Ethernet Controller supports the IEEE802.3/IEEE802.3u LAN standard, and supports two data

transmission rate: 10Mbps and 100Mbps. CPU exchanges data with the Ethernet through the

Ethernet Controller.

2-5

Analog Output

The D/A converter converts the digital ECG/IBP signals sent from CPU to the analog signals,

which are provided for the external after low-pass filtered by the filter and amplified by the

amplifier.

FPGA and VRAM

VRAM stores the displayed data. CPU stores the displayed data to VRAM through FPGA. FPGA

gets data from VRAM, processes them, and then sends them to the relevant graphic display

device.

In addition, FPGA also extends multiple serial ports, which communicate with peripheral

modules. FPGA transfers the received data to CPU through the bus; CPU delivers data to FPGA

through the bus, and then the FPGA transfers those data to the peripheral modules.

Watchdog

When powered on, watchdog provides reset signals for CPU, FPGA and Ethernet Controller.

The patient monitor provides the watchdog timer output and voltage detection functions.

2.2.2 ECG/RESP/TEMP Module

2.2.2.1 General

This module provides the function of measuring three parameters: electrocardiograph (ECG),

respiration (RESP) and temperature (TEMP).

2-6

2.2.2.2 Principle diagram

Figure 2-5 Working principle of the ECG/RESP/TEMP module

2.2.2.3 Principle

This module collects the ECG, RESP and TEMP signals through the transducer, processes the

signals, and sends the data to the main board through the serial port.

ECG Signal Input Circuit

The input protection and filtering circuits receive the ECG signal from the transducer, and filter

the high-frequency interference signal to protect the circuit against the damage by defibrillator

high-voltage and ESD.

The right-leg drive circuit gets the 50/60Hz power common-mode signal from the lead cable, and

sends the negative feedback signal to the human body to reject the common-mode interference

signal on the lead cable, which helps the detection of the ECG signal.

The lead-off detecting circuit checks whether the ECG lead is off, and sends the information to

CPU.

2-7

ECG Signal Process Circuit

The difference amplifying circuit conducts the primary amplification of the ECG signal and

rejects the common-mode interference signal.

The low-pas filtering circuit filters the high-frequency interference signal beyond the frequency

band of the ECG signal.

The PACE signal refers to the ECG pace signal. It has significant interference to the ECG signal

detection. The PACE rejection circuit can rejects the PACE signal, which helps the ECG signal

detection.

The main amplifying/filtering circuit conducts the secondary amplification of the ECG signal,

filters the signal, and then sends the ECG signal to the A/D conversion part.

Pace Detect

This part detects the PACE signal from the ECG signal and sends it to CPU.

Temperature Detect Circuit

This circuit receives the signal from the temperature transducer, amplifies and filters it, and then

sends it to the A/D conversion part.

Carrier Generate Circuit

The RESP measurement is based on the impedance method. While a man is breathing, the action

of the breast leads to changes of the thoracic impedance, which modulates the amplitude of the

high-frequency carrier signal. Finally, the modulated signal is sent to the measurement circuit.

The purpose of this module is generating the high-frequency carrier.

RESP Signal Input Circuit

This circuit couples the RESP signal to the detecting circuit.

RESP Signal Process Circuit

The pre-amplifying circuit conducts the primary amplification of the RESP signal and filters it.

The detecting circuit detects the RESP wave that has been modulated on the actuating signal.

The level shifting circuit removes the DC component from the RESP signal.

2-8

The main amplifying/filtering circuit conducts the secondary amplification of the RESP signal,

filters the signal, and then sends it to the A/D conversion part.

A/D

The A/D conversion part converts the analog signal to the digital signal, and sends the signal to

CPU for further processing.

CPU System

 Implementing the logical control of all parameter parts and A/D conversion parts;  Implementing the data processing for all parameters;  Implementing the communication with the main board.

Power & Signal isolate Circuit

 Isolating the external circuits to ensure the safety of human body;  Supplying power for all circuits;  Implementing the isolation communication between the CPU System and the main board.

2.2.3 IBP Module

2.2.3.1 General

This module provides the function of measuring Invasive Blood Pressure (IBP).

2.2.3.2 Principle diagram

Figure 2-6 Working principle of the IBP module

2-9

2.2.3.3 Principle

This module collects the IBP signal through the transducers, processes it and sends it to the main

board throgh the serial port.

IBP Signal Process Network

The IBP signal is the differential signal. After the common-mode filtering, the difference signal is

amplified by the difference amplifying circuit which changes the dual-end signal to the

single-end signal. After the low-pass filtering, the IBP signal is sent to the CPU System for

processing.

CPU System

 Converting the analog signal obtained by the circuit to the digital signal;  Implementing the logical control of all parameter parts;  Implementing the data processing for the two parameters;  Implementing the communication with the CPU board.

Power & Signal isolate Circuit

 Isolating the external circuits to ensure the safety of human body;  Supplying power for all circuits;  Implementing the isolation communication between the CPU System and the main board.

2-10

2.2.4 SpO2 Module

2.2.4.1 General

This module provides the function of measuring the Pulse Oxygen Saturation (SPO2).

2.2.4.2 Principle diagram

Figure2-7 Working principle of the SpO2 module

2.2.4.3 Principle The SpO2 measurement principle

1. Collecting the light signal of the red light and infrared transmitting through the finger or toe

which is pulsing;

2. Processing the collected signal to get the measured result.

The drive circuit of the LED and the gain of the amplifying circuit should be controlled according

to the different perfusions and transmittances of the tested object.

Led Drive Circuit

This circuit supplies the LED with the drive current, which can be regulated.

SPO2 Signal Process Network

The pre-amplifying circuit converts the photoelectric signal to the voltage signal and conducts the

primary amplification.

The gain adjusting and amplifying circuit conducts the secondary signal amplification and adjusts

the gain.

2-11

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