Mindray DPM5 User manual

Service Manual (V 3.0)

Copyright

Statement

Mindray DS USA, Inc. (hereinafter called Mindray DS) owns all rights to this unpublished work

and intends to maintain this work as confidential. Mindray DS may also seek to maintain this

work as an unpublished copyright. This publication is to be used solely for the purposes of

reference, operation, maintenance, or repair of Mindray DS equipment. No part of this can be

disseminated for other purposes.

In the event of inadvertent or deliberate publication, Mindray DS intends to enforce its rights to

this work under copyright laws as a published work. Those having access to this work may not

copy, use, or disclose the information in this work unless expressly authorized by Mindray DS

to do so.

All information contained in this publication 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 material. This publication may refer to information and

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 does not assume any liability

arising out of any infringements of patents or other rights of third parties.

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.

Content of this manual is subject to changes without prior notice.

PROPERTY OF Mindray DS USA, Inc.ALL RIGHTS RESERVED

Responsibility on the manufacturer party

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

• any installation, expansion, change, modification and repair of this equipment are not

conducted by Mindray DS qualified personnel;

• applied electrical appliance does not comply with relevant National Standards;

• the monitor is not operated under strict observance of this manual.

Warning

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Service Manual (V 3.0)

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 T o avoid elec trical 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.

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Service Manual (V 3.0)

Warranty

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

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANT ABILITY OR

FITNESS FOR ANY PARTICULAR PURPOSE.

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 substitution upon it of parts or accessories

not approved by Mindray DS or repaired by anyone other than a Mindray DS authorized

representative.

This warranty shall not extend to any instrument which has been subjected to misuse,

negligence or accident; any instrument from which Mindray DS 's original serial number tag or

product identification markings have been altered or removed, or any product of any other

manufacturer.

Safety, Reliability and Performance

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

DPM5 Patient Monitor if:

■ assembly operations, extensions, re-adjusts, modifications or repairs are carried out

by persons other than those authorized by Mindray DS.

■ the DPM5 is not used in accordance with the instructions for use, or the electrical

installation of the relevant room does not comply with NFPA 70: National Electric

Code or NFPA 99: Standard for Health Care Facilities (Outside the United States, the

relevant room must comply with all electrical installation regulations mandated by the

local and regional bodies of government).

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Service Manual (V 3.0)

Return Policy

Return Procedure

In the event that it becomes necessary to return a unit to Mindray DS, the following procedure

should be followed:

1. Obtain return authorization. Contact the Customerr Service Department and obtain a

Customer Service Authorization (Mindray DS) number. The Mindray DS number must

appear on the outside of the shipping container. Return shipments will not be accepted if

the Mindray DS 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 equipment 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: [phone] 1.201.995.8000

Website: www. mindray.com

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Service Manual (V 3.0)

Safety Precautions

1. Meaning of Signal Words

In this manual, the signal words WARNING and CAUTION are used regarding safety

and other important instructions. The signal words and their meanings are defined as follows.

Please understand their meanings clearly before reading this manual.

Signal word Meaning

WARNING

CAUTION

Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury.

2. Meaning of Safety Symbols

Symbol Description

Type-BF applied part

"Attention" (Refer to the operation manual.)

Safety Precautions

Please observe the following precautions to ensure the safety of service engineers as well as

operators when using this system.

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Service Manual (V 3.0)

WARNING: Do not connect this system to outlets with the same circuit

breakers an d fuses that co ntrol current to devices such as
life-support systems. If this system malfunctions and
generates an over current , or when there is an instantaneous
current at power ON, the circuit breakers and fuses of the
building’s supply circuit may be tripped.
Do not use flammable gases 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

(1) Use of radio-wave-emitting devices in the proximity of this

kind of medical electronic system 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.

(2) If a user brings a device which generates radio wav es 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.

VI

Symbols

Service Manual (V 3.0)

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

@ Mark Event 》 Next menu

*** Highest level alarm ** Middle level alarm

* Lowest level alarm

Ð Trend graph cursor u SYS pressure（NIBP trend graph）

t DIA pressure(NIBP trend graph) * MEAN pressure (NIBP trend

graph)

Î Right moving indicator Í Left moving indicator

Be Careful Protective earth ground

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

Silence Symbol ！ Close all alarm volume

Alarm pause

Heart beat

× Gain magnify √ Confirm

SN Series Number

VII

Pace signal

FOR YOUR NOTES

Service Manual (V 3.0)

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Service Manual (V 3.0)

Contents

CHAPTER 1 ABOUT THE PRODUCT..............................................................................................1

1.1 INTRODUCTION................................................................................................................................1

1.2 APPLICATION ...............................................................................................................................1

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

CHAPTER 2 PRINCIPLES ............................ .............................. ........................................................5

2.1 GENERAL ...........................................................................................................................................5

2.1.1 Parameter Measurement....................................................................................................5

2.1.2 Main Control Part............................................................................................ ..................6

2.1.3 Man-Machine Interface......................................................................................................6

2.1.4 Power Supply......................................................................................................................6

2.1.5 Other Auxiliary Functions................................... ............................... ................................6

2.2 HARDWARE DESCRIPTION ..........................................................................................................7

2.2.1 Main Board.........................................................................................................................8

2.2.2 ECG/RESP/TEMP Module........................... ... .... ... .. ..... .. .. ..... .. ... ..... .. ..... .. .. ..... .. ... .... ... .. ....9

2.2.3 CO/IBP Module................................. .... ... .. ..... .. ..... .. .. ..... .. ... .... ... .. ..... .. ... .... ... .. ..... .. .. ..... ..12

2.2.4 SpO2 Module...................................... ...............................................................................13

2.2.5 NIBP Module..................................... .. .. ..... .. ... .... ... .. ..... .. .. ..... .. ... ..... .. ..... .. .. ..... .. ... .... ... .. ..14

2.2.6 Recorder Module............................ ... .. ..... .. .. ..... .. ..... .. ... .... ... .. ..... .. .. ..... ... .. ..... .. .. ..... .. ... ....15

2.2.7 Button Panel.................................................... ............................................................. ....16

2.2.8 Power PCB.......................................................................................................................17

2.3 SOFTWARE DESCRIPTION ........................................................................................................18

2.3.1 General.............................................................................................................................18

2.3.2 System Task................................................. ....... ......... ....... .......... ....... ......... ....... .......... ....19

2.3.3 System Function................ .......................................................................................................20

2.4 SYSTEM PARAMETER................................................................................................................21

2.4.1 General.............................................................................................................................21

2.4.2 ECG/RESP........................................ ............................... .................................................21

2.4.3 NIBP ........................................................ .........................................................................22

2.4.4 SpO2........................... ............................... ........................................................................23

2.4.5 TEMP................................................................................................................................23

2.4.6 IBP....................................................................................................................................23

2.4.7 CO.....................................................................................................................................24

2.4.8 CO2............................ ............................... ........................................................................24

2.4.9 AG..................................... ............................... .................................................................24

CHAPTER 3. PRODUCT SPECIFICATIONS................................................... ............................27

3.1. SAFETY CLASSIFICATIONS........................................................................................................27

3.2. ENVIRONMENTAL SPECIFICATIONS ..........................................................................................27

3.3. POWER SOURCE SPECIFICATIONS ..........................................................................................28

3.4. HARDWARE SPECIFICATIONS ...................................................................................................29

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3.5. WIRELESS NETWORK ................................................................................................................30

3.6. DATA STORAGE .........................................................................................................................30

3.7. SIGNAL OUTPUT SPECIFICATIONS ...........................................................................................30

3.8. ECG SPECIFICATIONS..............................................................................................................31

3.9. RESP SPECIFICATIONS............................................................................................................36

3.10. SPO

SPECIFICATIONS .........................................................................................................36

2

3.11. NIBP SPECIFICATIONS .........................................................................................................38

3.12. TEMP SPECIFICATIONS .......................................................................................................39

3.13. IBP SPECIFICATIONS ............................................................................................................39

3.14. CO SPECIFICATIONS ............................................................................................................40

3.15. CO

SPECIFICATIONS...........................................................................................................40

2

3.16. AG SPECIFICATIONS ............................................................................................................43

CHAPTER 4 DISASSEMBLING/ASSEMBLING & TROUBLESHOOTING...............................45

4.1 DPM5 DISASSEMBLING/ASSEMBLING.....................................................................................45

4.1.2 DPM5 Display (TFT Display) Assembly ........................................................................46

4.1.3 DPM5 Support Assembly (Lithiu m Battery) (920 1-30-35944)......................................47

4.1.4 Front Cover Assembly.........................................................................................................48

4.1.5 Back Cover Assembly..........................................................................................................49

4.1.6 Microstream CO2 Assembly................................................................................................50

4.2 TROUBLESHOOTING ..................................................................................................................51

4.2.1 Black Screen, Startup Failure........... ..................................................................................51

4.2.2 White Screen & Other Abnormal Screen.........................................................................52

4.2.3 Encoder Faults..................................................................... .................................................52

4.2.4 No Audio Alarm................................................. ............................................................. .......52

4.2.5 Printing Failure............................. ............................... ..........................................................52

4.2.6 Abnormal Paper Drive.........................................................................................................52

CHAPTER 5 TEST AND MATERIAL LIST.....................................................................................53

5.1 TEST PROCEDURE ....................................................................................................................53

5.1.1 Connection and Checking...................................................................................................53

5.1.2 Functions of Buttons............................................................................................................53

5.1.3 ECG/RESP............................................................................................................................53

5.1.4 Temperature .......................................................................................... ................................53

5.1.5 NIBP........................................................................................................................................54

5.1.6 SpO2............................ ............................... .............................................................................54

5.1.7 IBP...........................................................................................................................................54

5.1.8 CO......................................... ............................................................. .....................................55

5.1.9 CO2............................ ............................... ...............................................................................55

5.1.10 Water trap............................................................................................................................55

5.1.11 Recorder................................................................................................. ..............................56

5.1.12 Power Supply............................. ............................................................. ............................56

5.1.13 Clock .................................................................................... .................................................56

5.1.14 System Test................................................................... ......................................................57

5.2 NIBP CALIBRATION...................................................................................................................57

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Service Manual (V 3.0)

5.3 IBP CALIBRATE .........................................................................................................................57

5.4 CO2 CHECK..................................................................................................................................60

5.5 AG CALIBRATE ............................................................................................................................61

5.6 DPM5 MATE RIAL LIST..............................................................................................................63

CHAPTER 6 MAINTENANCE AND CLEANING............................. .................................................65

6.1 MAINTENANCE .................................................................................................................................65

6.1.1Checking Before Using.........................................................................................................65

6.1.2 Regular Checking.................................................................................................................65

6.2 CLEANING..................................................................................................................................65

6.3 CLEANING REAGENT ................................................................................................................65

6.4 STERILIZATION ..........................................................................................................................66

6.5 DISINFECTION ...........................................................................................................................66

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Service Manual (V 3.0)

FOR YOUR NOTES

4

Chapter 1 About the Product

Chapter 1 About the Product

1.1 Introduction

The DPM5 Patient Monitor, a portable and accessible patient monitor, is supplied by

rechargeable batteries or external AC power, which applies to adults, pediatric and neonates.

You can select different configurations as required. Besides, the

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

the DPM5 can monitor include: ECG, RESP, SpO

and CO

freezing and recording, is a compact and lightweight patient monitor. Its color TFT LCD is able

to show patient parameters and 8 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 DPM5 Patient Monitor measures patient’s ECG, NIBP, SpO

CO

and 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.

. It, integrating the functions of parameter measurement, waveform monitoring,

2

physiological signals through the ECG electrode, SpO2 sensor, cuff, temperature sensor

2

, NIBP, 2-channel TEMP, 2-channel IBP, CO

2

DPM5 can be connected with

, TEMP, RESP, IBP, CO and

2

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, SpO

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.

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

2

1

Chapter 1 About the Product

1.2.2 Usage

Parameters that the DPM5 can monitor include: ECG, RESP, SpO2, NIBP, TEMP, IBP, CO

AGand CO

. DPM5 converts these physiological signals to digital signals, processes them and

2

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. Usually, patient

monitors are seen in some clinical areas in hospital, such as ICU, CCU, intensive care units for

heart disease patients, operating rooms, emergency departments and observation wards.

They can also be used in clinics. The DPM5 patient monitor should be run under the control of

clinical staff.

DPM5 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

2

), Pulse Rate (PR) SpO2

2

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

(NM)

TEMP T1, T2, TD

IBP CH1: SYS, DIA

CH2: SYS, DIA

IBP waveform

CO Temperature of blood (TB)

Cardiac Output (CO)

End-tidal carbon dioxide (EtCO2)

CO

2

Inspired minimum CO

(InsCO2)

2

Airway Respiration Rate (AwRR)

AG

Inhaled and exhaled CO

2

(FiCO2, EtCO2)

2

Chapter 1 About the Product

Inhaled and exhaled N2O (FiN2O, EtN2O)

Inhaled and exhaled O

(FiO2, EtO2)

2

Inhaled and exhaled anesthetic agent (FiAA, EtAA, where AA

refers to any of the following anesthetic agents.)

HAL (Halothane)

ISO (Isoflurane)

ENF (Enflurane)

SEV (Sevoflurane)

DES (desflurane)

Airway Respiration Rate (rpm: Respiration Per Minute): AwRR

Minimum Alveolar Concentration (MAC)

4 AG waveforms (CO

, N2O, O2, AA)

2

The DPM5 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.

3

Chapter 1 About the Product

FOR YOUR NOTES

4

Chapter 2 Principles

Chapter 2 Principles

2.1 General

The intended use of the DPM5 patient monitor is to monitor a fixed set of parameters including

ECG, RESP, SpO

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.

, NIBP, TEMP, IBP, CO and CO2 (IBP, CO and CO2 are optional). It consists

2

Figure 2-1 Structure of the DPM5

2.1.1 Parameter Measurement

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

parameter measurement part of the DPM5 patient monitor consists of the measurement probe,

5

Chapter 2 Principles

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

This part converts the physiological signals to electric signals, processes the 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 DPM5 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 DPM5 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.

2.1.4 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 respectively to the 5V DC and 12V 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 DPM5 patient monitor also provides the network upgrade function for the service

engineers to upgrade the system software without disassembling the enclosure.

6

Chapter 2 Principles

2.2 Hardware Description

The structure of the DPM5 patient monitor is shown in the following figure.

Figure 2-2 Functional structure of the DPM5

7

Chapter 2 Principles

The DPM5 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.

2.2.1.2 Principle diagram

Figure 2-4 Working principle of the main board

8

Chapter 2 Principles

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.

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).

9

Chapter 2 Principles

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.

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.

10

Chapter 2 Principles

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.

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.

11

Chapter 2 Principles

2.2.3 CO/IBP Module

2.2.3.1 General

This module provides the function of measuring two parameters: Cardiac Output (CO) and

Invasive Blood Pressure (IBP).

2.2.3.2 Principle diagram

Figure 2-6 Working principle of the CO/IBP module

2.2.3.3 Principle

This module collects the CO/IBP signal through the transducers, processes it and sends it

to the main board throgh the serial port.

CO Signal Process Network

The CO parameter is measured with the thermal dilution method. The transducer

sends two signals (TI: Temperature of Injectate; TB: Temperature of Blood) to the CO

Signal Process Network. After that, the signals are amplified and low-pass filtered, and

then sent to the CPU System for processing.

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 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.

12

Chapter 2 Principles

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 SpO

measurement principle

2

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.

The biasing circuit adjusts the dynamic range of the signal, and sends it to the A/D conversion

part.

A/D

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

CPU for further processing.

D/A

The D/A conversion part converts the digital signal received from CPU to the analog signal,

and provides the control signal for the Led Drive Circuit and SPO2 Signal Process Network.

13

Chapter 2 Principles

CPU System

 Implementing the logical control of all the circuits;
 Implementing the data processing for the SpO

parameter;

2

 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.

2.2.5 NIBP Module

2.2.5.1 General

This module provides the function of measuring the Non-Invasive Blood Pressure (NIBP)

parameter.

2.2.5.2 Principle diagram

Figure 2-8 Working principle of the NIBP module

2.2.5.3 Principle

The NIBP is measured based on the pulse vibration principle. Inflate the cuff which is on the

forearm till the cuff pressure blocks the arterial blood, and then deflate the cuff according to a

specified algorithm. While the cuff pressure is decreasing, the arterial blood has pulses, which

are sensed by the pressure transducer in the cuff. Consequently, the pressure transducer,

connected with the windpipe of the cuff, generates a pulsation signal, which is then processed

by the NIBP module to get the NIBP value.

Valve Drive Circuit

This circuit controls the status (ON/OFF) of valves. It, together with the Motor Drive Circuit,

14

Chapter 2 Principles

implements the inflation and deflation of the cuff.

Motor Drive Circuit

This circuit controls the action of the air pump. It, together with the Valve Drive Circuit,

implements the inflation and deflation of the cuff. Besides, it provides the status signal of the

motor for the A/D conversion part.

NIBP Signal Process Network

The NIBP signal is the differential input signal. The difference amplifying circuit amplifies the

dual-end difference signal and converts it to the single-end signal; meanwhile, this circuit

sends a channel of signal to the A/D conversion part, and the other to the DC isolating and

amplifying circuit.

The DC isolating and amplifying circuit removes DC components from the signal, amplifies 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 it to the

CPU System for further processing.

Over Pressure Detect

The circuit detects the NIBP pressure signal. Once the pressure value exceeds the protected

pressure value, it will send a message to the CPU System, which asks the Valve Drive Circuit

to open the valve to deflate the cuff.

CPU System

 Implementing the logical control of all the circuits;
 Implementing the data processing for the NIBP parameter;
 Implementing the communication with the main board.

2.2.6 Recorder Module

2.2.6.1 General

This module is used to drive the heat-sensitive printer.

2.2.6.2 Principle diagram

Figure 2-9 Working principle of the recorder module

2.2.6.3 Principle

This module receives the to-be-printed data from the main board, converts them to the dot

matrix data, sends them to the heat-sensitive printer, and drives the printer.

15

Chapter 2 Principles

Step Motor Drive Circuit

There is a step motor on the heat-sensitive printer. The step motor drives the paper. This

circuit is used to drive the step motor.

Printer Status Det ect Circuit

This circuit detects the status of the heat-sensitive printer, and sends the status information to

the CPU system. The status information includes the position of the paper roller, status of the

heat-sensitive recorder paper and the temperature of the heat-sensitive head.

CPU System

 Processing the data to be printed;
 Controlling the heat-sensitive printer and step motor;
 Collecting data about the status of the heat-sensitive printer, and controlling the

printer;

 Implementing the communication with the main board.

2.2.7 Button Panel

2.2.7.1 General

This module provides a man-machine interactive interface.

2.2.7.2 Principle diagram

Figure 2-10 Working principle of the button panel

2.2.7.3 Principle

This module detects the input signals of the button panel and control knob, converts the

detected input signals to codes and then sends to the main board. The main board sends

commands to the button panel, which, according to the commands, controls the status of the

LED and the audio process circuit to give auditory/visual alarms.

CPU

 Detecting the input signal of the button panel and control knob;
 Controlling the status of LED;
 Controlling the audio process circuit;

16

Chapter 2 Principles

 Regularly resetting the Watchdog timer;
 Communicating with the main board.

Audio Process Circuit

This circuit generates audio signals and drives the speaker.

Watchdog

When powered on, the Watchdog provides the reset signal for CPU.

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

2.2.8 Power PCB

2.2.8.1 General

This module provides DC working current for other boards.

2.2.8.2 Principle diagram

Figure 2-11 Working principle of the power PCB

2.2.8.3 Principle

This module can convert 220V AC or the battery voltage to 5V DC and 12V DC voltages, which

are supplied for other boards. When the AC voltage and batteries coexist, the AC voltage is

supplied for the system and used to charge the batteries.

AC/DC

This part converts the AC voltage to the low DC voltage for the subsequent circuits; besides, it

supplies the power for charging the batteries.

Battery Control Circuit

When the AC voltage and batteries coexist, this circuit controls the process of charging the

batteries with the DC voltage converted by the AC/DC part. When the AC voltage is

unavailable, this circuit controls the batteries to supply power for the subsequent circuits.

5V DC/DC

This part converts the DC voltage to the stable 5V DC voltage and supplies it for the external

boards.

17

Chapter 2 Principles

12V DC/DC

This part converts the DC voltage to the stable 12V DC voltage and supplies it for the external

boards.

Power Switch Circuit

This circuit controls the status of the 5V DC/DC part and the 12V DC/DC part, thus to control

the switch of the patient monitor.

Voltage Detect Circuit

This circuit detects the output voltages of the circuits, converts the analog signal to the digital

signal, and sends the digital signal to the main board for processing.

2.3 Software Description

2.3.1 General

Figure 2-12 System function

As shown in Figure 2-12, in the red frame is the software system, on the left to the red

frame are the inputs of the software system, and on the right to the red frame are the

outputs. The parameter measurement module exchanges data with the software through

the serial port, while the user interacts with the system through the button panel. Among

the output devices, the recorder and alarm device receive data through the serial ports,

the analog output component is an MBUS component, and the LCD and network

controller are controlled directly by CPU.

18

Chapter 2 Principles

2.3.2 System Task

NO Task Function Period

System initialization Initializing the system

1

Data processing Analyzing and saving the data 1 second

2

Display of timer

3

information

Switchover of modules

5

and screens

Processing of user

commands and

6

screens

System monitoring

7

Network connection Implementing the network connection 1 second

8

Network data sending Sending the network data 1 second

9

Network data receiving Receiving the network data (viewbed) 1 second

10

ECG analysis

11

Record output Outputting records

12

NIBP processing Implementing NIBP-related processing 1 second

13

WATCHDOG task Managing the system watchdog 1 second

14

Implementing the timed refreshing 1 second

Switching over between waveforms and

parameters on the screen

Processing the user inputs by buttons and

displaying them on the screen.

System monitoring, voltage monitoring and

battery management

Analyzing ECG signal, calculating ECG values

(HR, ARR and ST), and saving the analysis

results.

In case of a

startup

In case of a

screen change

event

In case of a

button event

1 second

1 second

In case of a

record event

19

Chapter 2 Principles

2.3.3 System Function

The system tasks can be classified as follows.

Figure 2-13 System task

20

Chapter 2 Principles

2.4 System Parameter

2.4.1 General

For the DPM5 patient monitor, signals are collected by modules, and the results are

transferred to the main board through the adapter board, thus to process and display the data

and waveforms. Commands from the main board, as well as the status information of modules,

are transferred through the adapter board. In addition, the adapter board adapts and changes

the power supply. The structure of the whole system is shown in the following figure.

Figure 2-14 System structure

As shown in Figure 2-14, the five modules and measurement cables monitor and measure

NIBP, SpO

, ECG/RESP/TEMP, IBP/CO and CO2 in real time, and send the results to the main

2

board for processing and displaying. If necessary, the results are sent to the recorder for

printing.

The parameter monitoring functions are described respectively in the following sections.

2.4.2 ECG/RESP

■ ECG

The DPM5 patient monitor has the following ECG functions:

1) Lead type: 3-lead, 5-lead, 12-lead

2) Lead way:

3-lead (1 channel):

5-lead (2 channels):

I, II, III

I, II, III, aVR, aVL, aVF, V

21

Chapter 2 Principles

12-lead (8 channels): I, II, III, aVR, aVL, aVF, V1-V6, CAL

3) Floating input

4) Right-foot drive

5) Lead-off detection

6) 2-channel ECG waveform amplification; processing ECG signals of any two leads

■ The ECG circuit processes the ECG signals. It consists of the following parts:

1) Input circuit: The input circuit protects the ECG input level, and filters the ECG signals

and external interference. The ECG electrode is connected to the input circuit through the

cable.

2) Buffer amplifying circuit: This circuit ensures extremely high input impedance and low

output resistance for ECG.

3) Right-foot drive circuit: The output midpoint of the buffer amplifying circuit is fed to the

RL end of the 5-lead after the inverse amplification, so as to ensure that the human body

is in the equipotential state, decrease the interference, and increase the common-mode

rejection ratio of the circuit.

4) Lead-off detection: The lead-off causes changes in the output level of the buffer

amplifying circuit. Therefore, the lead-off can be detected with a comparator, and the state

of lead-off can be converted TTL level for the Micro Controller Unit (MCU) to detect it.

5) Lead circuit: Under the control of MCU, the lead electrodes should be connected to the

main amplification circuit.

6) Main amplification circuit: The measurement amplifier is composed of 3 standard

operation amplifiers.

7) Subsequent processing circuit: This circuit couples the ECG signals, remotely controls

the gains, filters the waves, shifts the level, amplifies the signal to the specified amplitude,

and sends the signal to the A/D converter.

■ RESP

The DPM5 patient monitor measures the RESP based on the impedance principle. While

a man is breathing, the action of the breast leads to impedance changes between RL and

LL. Change the high-frequency signal passing the RL and LL to amplitude-modulation

high-frequency signal (AM high-frequency signal), which is converted to the electric signal

after being detected and amplified and then sent to the A/D converter. The RESP module

consists of the RESP circuit board and coupling transformer. The circuit has several

functions: vibration, coupling, wave-detection, primary amplification and high-gain

amplification.

2.4.3 NIBP

The NIBP is measured based on the pulse vibration principle. Inflate the cuff which is

on the forearm till the cuff pressure blocks the arterial blood, and then deflate the cuff

according to a specified algorithm. While the cuff pressure is decreasing, the arterial

blood has pulses, which are sensed by the pressure transducer in the cuff.

Consequently, the pressure transducer, connected with the windpipe of the cuff,

generates a pulsation signal. Then, the pulsation signal is filtered by a high-pass filter

(about 1Hz), amplified, converted to the digital signal by the A/D converter, and finally

processed by the MCU. After that, the systolic pressure, diastolic pressure and mean

22

Chapter 2 Principles

pressure can be obtained. For neonates, pediatric and adults, it is necessary to select

the cuffs of a proper size to avoid possible measurement errors. In the NIBP

measurement, there is a protection circuit used to protect patient from over-high

pressure.

The NIBP measurement modes include:

1) Adult/pediatric/neonate mode: To be selected according to the build, weight and age

of the patient;

2) Manual/Auto/Continuous mode: The manual measurement is also called single

measurement; in this mode, only one measurement is done after being started. In the

auto measurement mode, the measurement can be done once within the selected

period, with the interval being 1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 180, 240 or 480

minutes. In the continuous measurement mode, quick continuous measurement will be

done within 5 minutes after being started; it detects the changes in blood pressure

effectively.

2.4.4 SpO2

The SpO2 value is obtained through the pulse waves of the finger tips based on specific

algorithm and clinical data. The SpO

probe is the measurement transducer. It has two

2

inbuilt LEDs and an inbuilt light receiver. The two LEDs include one red-light diode and

one infrared diode, which emit light in turns. When the capillaries in the finger tip are

iteratively congested with blood pumped by the heart, the light emitted by the LEDs, after

absorbed by the capillaries and tissue, casts on the light receiver, which can sense, in the

form of electric signal, the light strength changing with the pulsated blood. The DC/AC

ratio of the two photoelectric signals corresponds to the content of the oxygen in the blood.

Therefore, the correct pulse oxygen saturation can be obtained with specific algorithm.

Moreover, the pulse rate can be obtained according to the pulse waveform.

The circuit of the SpO

module is involved in four parts: SpO2 probe, signal processing

2

unit, LED-driven sequencing control part and the MCU.

2.4.5 TEMP

Temperature measurement principle:

1. The transducer converts the body temperature to the electric signal;

2. The amplifier amplifies the electric signal;

3. The CPU processes the data.

The circuit is a proportional amplifier consisting of operation amplifiers. When the

temperature reaches the heat-sensitive probe, the heat-sensitive probe generates the

voltage signal, which is sent to the A/D converter after being amplified. The probe

detecting circuit is a voltage comparator consisting of operation amplifiers. When the

probe is disconnected, the voltage input is lower than the comparing voltage, so the

voltage comparator outputs the low level; when the probe is connected, the voltage input

is higher than the comparing voltage, so the voltage comparator outputs the high level.

2.4.6 IBP

The IBP module can monitor the arterial pressure, central venous pressure and

pulmonary arterial pressure.

23

Chapter 2 Principles

Measurement principle: Introduce a catheter, of which the external end is connected to

the pressure transducer, into the blood vessel under test, inject the physiological saline.

Since the liquid can be transferred by pressure, the pressure inside the blood pressure is

transferred by liquid to the pressure transducer, and the dynamic waveform of the

pressure inside the blood pressure is obtained in real time. Thus, the arterial pressure,

central venous pressure and pulmonary arterial pressure are obtained based on specific

algorithm.

2.4.7 CO

CO measurement principle: The thermal dilution method is widely used in the clinical CO

monitoring. Introduce a floating catheter into the pulmonary artery through the right atrium,

and inject the physiological saline into the right atrium through the catheter whose front

end is connected to the temperature transducer. When the cold liquid mixes with the

blood, there will be a change of temperature. Thus, when the blood mixed with the

physiological saline flows into the pulmonary artery, its temperature will be sensed by the

temperature transducer. According to the injection time and temperature change, the

patient monitor can analyze the CO, and calculate the Cardiac Index (CI), Stroke Volume

Index (SVI), SVIs of the left atrium and right atrium, Pulmonary Vascular Resistance (PVR)

and so on.

2.4.8 CO2

The CO2 module works based on the infrared spectrum absorption principle. According to

different connection methods, the infrared light transducer is classified as sidestream

infrared light transducer. The sidestream CO

module is composed of the circuit board,

2

inbuilt sidestream infrared light transducer, deflation pump and control. When used, this

module requires the external water trap, drying pipe and sampling tube. In the sidestream

mode, the deflation rate can be set to 100ml/min, 150ml/min or 200ml/min according to

the patient situation. In the AG monitoring, multiple compensations can be set, such as

hydrosphere, oxygen, temperature and desflurane (Des). When the CO

measurement is

2

not being conducted, the sidestream deflation pump and the infrared source are expected

to be shut down, thus to extend the service life and reduce the power consumption of the

module. There is no windpipe which is available in the sidestream mode.

2.4.9 AG

The Anesthesia Gas (AG) can be used to measure the AG and respiration gas of the

anesthetized patient. The AG concentration is measured based on the principle that the

AG has the property of absorbing the infrared. All gases that the AG module can measure

have the property of absorbing the infrared, and every gas has their own specific

absorption peculiarity.

AG measurement procedure:

1. Send the gas to be measured to a sampling chamber;

2. Use an optical infrared filter, select a specific band of infrared, and transmit it

through the gas;

3. Measure the infrared that gets through the gas to obtain the gas concentration.

24

Chapter 2 Principles

For a given volume, the higher the gas concentration is, the more absorbed infrared is,

and the less the infrared that gets through the gas is. For the measurement of multiple

gases, multiple infrared filters are required in the AG module.

The oxygen does not absorb the infrared within the above-mentioned wave band.

Therefore, the oxygen is measured based on its paramagnetism. Inside the transducer of

the O

module, there are two crystal balls full of nitrogen. They are suspended in the

2

symmetrical magnetic field, and designed to point to the strongest outgoing part of the

magnetic field. Outside the balls is the paramagnetic oxygen. Therefore, the balls are

forced, by the relatively stronger paramagnetic oxygen, out of the magnetic field. The

moment of the force acting on the balls is proportional to the paramagnetic strength as

well as to the concentration of the paramagnetic oxygen.

25

Chapter 2 Principles

FOR YOUR NOTES

26

Chapter 3 Product Specifications

Chapter 3. Product Specifications

3.1. Safety Classifications

Class I with internal electric power supply.

Type of protection against

electric shock

Degree of protection

against electric shock

Degree of protection

against hazards of ignition

of flammable anesthetic

mixtures

Degree of protection

against harmful ingress of

water

Mode of operation Continuous

Equipment type Portable

Where the integrity of the external protective earth (ground) in

the installation or its conductors is in doubt, the equipment shall

be operated from its internal electric power supply (batteries)

Sidestream, Microstream CO2/AG:

ECG/RESP/TEMP/SpO2/NIBP/IBP/

CO:

Not protected (ordinary)

Not protected (ordinary)

BF (defibrillation proof)

CF (defibrillation proof)

3.2. Environmental Specifications

0 to 40℃

Operating temperature

Operating humidity 15 to 95%, noncondensing

Operating altitude

Storage temperature

Storage humidity 10 to 95%, noncondensing

Storage and transportation

altitude

5 to 35℃

5 to 35℃

10 to 35℃

-500 to 4600 m (-1640 to 15092 feet)

-305 to 3014 m (-1000 to 9889 feet) (with CO2, AG, Masimo or

Nellcor SpO2 module)

-20 to 60℃

-500 to 13100 m (-1640 to 42979 feet)

-305 to 6096 m (-1000 to 20000 feet) (with CO2, AG, Masimo or

Nellcor SpO2 module)

(With Sidestream CO2 module)

(With Microstream CO2 module)

(With AION AG module)

27

Chapter 3 Product Specifications

3.3. Power Source Specifications

AC Power Supply Specifications

Input voltage

Current 1.4A to 0.6A

Frequency 50/60 Hz

Fuse T 3 A, 250 V

Internal battery

Number of batteries 2

Type Sealed lead-acid battery or lithium-ion battery

Time to shutdown >5 min (after the first low-power alarm)

Sealed lead-acid battery

Nominal voltage 12 VDC

Capacity 2.3 Ah

Operating time

Charge time

Lithium battery

Rated voltage 11.1 VDC

Capacity 4.4 Ah

Operating time

Charge time A maximum of 6.5h (in the running status or standby mode)

100 to 240 V～

48 minutes or 120 minutes typical when powered by one or two
new fully-charged batteries respectively (25℃, ECG, SpO2,

NIBP measurement per 15 minutes).

A maximum of 6 h for each battery, and a maximum of 12h for

both (in the running status or standby mode)

120 minutes or 300 minutes typical when powered by one or two
new fully-charged batteries respectively (25℃, ECG, SpO2,

NIBP measurement per 15 minutes).

28

Chapter 3 Product Specifications

3.4. Hardware Specifications

Physical

Size 318 × 270 × 137mm (width×height×depth)

Different due to different configurations

Weight

Display

Type Color TFT LCD

Size 12.1 inches (diagonal)

Resolution 800×600 pixels

Recorder

Type Thermal dot array

Horizontal resolution 160 dots/cm (at 25 mm/s recording rate)

Vertical resolution 80 dots/cm

Width of the recorder paper 50 mm

Length of the recorder paper 20 m

Recording rate 25 mm/s, 50 mm/s

Recorded waveforms 3

Standard configuration: 4.7kg

Maximum weight: ≤ 7.5kg

LED indicator

Alarm indicator 1 (yellow and red)

Running status indicator 1 (green)

AC power indicator 1 (green)

Battery indicator 1 (green)

Audio indicator

Giving audio alarms (45 to 85 dB), keypad tones, and

Speaker

Connectors

Power supply 1 AC power connector

Network 1 standard RJ45 network connector, 100 BASE-TX

VGA 1 standard color VGA monitor connector, 15-PIN D-sub

Auxiliary output 1 BNC connector

Equipotentiality 1 equipotential grounding connector

heartbeat/pulse tone.

Supporting PITCH TONE and multi-level volume.

Audio alarms comply with EN 60601-1-8 and IEC60601-1-8.

29

Chapter 3 Product Specifications

3.5. Wireless network

Standards IEEE 802.11b, Wi-Fi compatible

Frequency range 2.412 to 2.462GHz

China America Canada Europe Spain France Japan

Operating channel

Safe distance 10m (a circle centering AP with the diameter of 10m)

Maximum data rate 11Mbps

1 to 11 10, 11 2

For other country, please refer to your local law.

3.6. Data Storage

Trend data

Alarm events

ARR events 80 ARR events and associated waveforms with 8s wavelength.

NIBP measurements

Long trend: 96 hours, resolution 1min, 5 min or 10 min.

Short trend: 1 hour, resolution 1 s or 5 s.

70 alarm events and associated waveforms (with user

selectable waveform length 8s, 16 or 32).

800 NIBP groups, including systolic pressures, mean pressures,

diastolic pressures and measurement time.

3.7. Signal Output Specifications

Standards

Output impedance 50Ω

ECG analog output

Bandwidth (-3dB; reference

frequency: 10Hz)

Maximum propagation delay 25 ms (In DIAGNOSTIC mode, NOTCH is OFF)

Sensitivity 1 V/mV± 5%

PACE rejection/enhancement No pace rejection or enhancement

Meets the requirements of EC60601-1 for short-circuit

protection and leakage current

Diagnostic mode:

Monitor mode:

Surgery mode:

0.05 to 100 Hz (812A module)

0.05 to 150 Hz (M08A module)

0.5 to 40 Hz

1 to 20 Hz

IBP analog output

Bandwidth 0 to 12.5 Hz (-3 dB, reference frequency: 1 Hz)

Maximum propagation Delay 55 ms (the filter function is disabled)

Sensitivity 1 V/100 mmHg ±5%

Nurse call output

Driver Relay

Electrical specifications ≤60W, ≤2A, ≤36VDC, ≤25VAC

30

Chapter 3 Product Specifications

Conducting resistance < 1Ω

Isolation voltage > 1500 VAC

Signal type Normally open or normally closed, selectable

Defibrillator synchronization pulse

Maximum time delay 35 ms (R-wave peak to leading edge of the pulse)

Amplitude 3.5 V (min) at 3 mA sourcing; 0.8 V (max) at 1 mA sinking

Pulse width 100 ms ±10%

Rising and falling time < 3 ms

VGA

Connector type 15-PIN D-sub socket

Signal RGB: 0.7 Vp-p/75Ω;

Horizontal/vertical synchronization: TTL level

3.8. ECG Specifications

Mindray DS Software Package

Lead naming style AHA, EURO

The lead resistance is no greater than 51 kΩ and it is in parallel

with a 0.047 µF capacitor, it will not cause a lead fault condition.

Lead fault

Sensitivity selection

Sweep speed 12.5 mm/s, 25 mm/s, 50 mm/s

Bandwidth (-3 dB)

Common mode rejection

50/60Hz Notch Filtering The monitor provides software filtering against the 50/60HZ

Input offset current ≤0.1μA (except currents to drive leads)

Differential input impedance ≥ 5MΩ

Input signal range ±8mV (peak-to-peak value)

For 3/5-lead, differential offsets ≤ ±300 mV, it will not cause a

lead fault condition.

For 12-lead, differential offsets ≤ ±500 mV, it will not cause a

lead fault condition.

1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5),

10 mm/mV (×1), 20 mm/mV (×2) and AUTO

Diagnostic mode:

Monitor mode:

Surgery mode:

Diagnostic mode:

Monitor mode:

Surgery mode:

(The notch filter is turned off.)

industrial frequency.

In monitor and surgery modes, the 50/60HZ filter will be turned

on automatically.

In diagnostic mode, the 50/60HZ filter will be turned off.

0.05 to 100 Hz (812A module)

0.05 to 150 Hz (M08A module)

0.5 to 40 Hz

1 to 20 Hz

≥90 dB

≥105 dB

≥105 dB

31

Chapter 3 Product Specifications

Accuracy of input signal

reproduction

Auxiliary current (Leads off

detection)

Methods A and D were used to establish overall system error and

frequency response according to EC11.

Active electrode: < 0.1 μA

Reference electrode: < 1 μA

Patient leakage current < 10uA

Recovery time after

defibrillation

Calibration signal

< 5s

1 mV (peak-to-peak value), precision: ±5%

ESU protection Incision mode: 300W

Congelation mode: 100W

Restore time: ≤10s

The monitor complies with the requirements of ANSI/AAMI

EC13 Section 4.2.9.14.

ESU noise control The monitor uses the ECG leads meeting the requirements of

AAMI; based on the ECG baseline, the peak noise ≤ 2mV

The monitor complies with the test method in EC13 Section

5.2.9.14.

HR

Measurement range

Neonate:

Pediatric:

Adult:

15 to 350 bpm

15 to 350 bpm

15 to 300 bpm

Resolution 1 bpm

Precision ±1 bpm or ±1%, whichever is greater.

Trigger threshold level 200 μV (lead II)

Trigger indication There will be an audible beep on every beat captured.

Heart Rate Averaging The average Heart Rate is computed in line with the ANSI/AAMI

EC13 Section 4.1.2.1 d) as follows:

When the last 3 R-to-R intervals > 1200 ms, compute the average

of the last 4 R-to-R intervals; otherwise, compute the average of

the last 12 R-to-R intervals minus the longest and shortest

intervals.

The displayed Heart Rate is updated once per second.

Heart Rate Meter Accuracy

and Response to Irregular

Rhythm

When tested in accordance with the ANSI/AAMI EC13 Section

4.1.2.1 e), the indicated heart rate after a 20 second stabilization

period is:

Figure 3a (Ventricular Bigeminy) -80±1 bpm

Figure 3b (Slow Alternating Ventricular Bigeminy) -60±1 bpm

Figure 3c (Rapid Alternating Ventricular Bigeminy) -120±1bpm

Figure 3d (Bi-directional Systoles) -90±2 bpm

Response time to heart rate

changes

Meets the requirement of ANSI/AAMI EC13 Section 4.1.2.1 f).

Less than 11 sec for a step increase from 80 to 120 BPM

Less than 11 sec for a step decrease from 80 to 40 BPM

32

Chapter 3 Product Specifications

When tested in accordance with ANSI/AAMI EC13 Section

4.1.2.1 g, the response time is as follows:

Figure 4ah – range: 15.7 to 19.2s, average: 17.4s

Response time of tachycardia

alarm

4a – range: 5.7 to 8.5s, average: 7.5s

4ad – range: 3.6 to 5.1s, average: 4.2s

Figure 4bh – range: 11.5 to 14.7s, average: 12.9s

4b – range: 4 to 14s, average: 7.2s

4bd – range: 6.6 to 14.5s, average: 10.5s

Tall T-Wave Rejection When tested in accordance with the ANSI/AAMI EC13 Section

4.1.2.1 c), the heart rate meter will reject all T-waves with

amplitudes less than 1.2 mV, 100 ms QRS, a T wave duration of

180ms and a Q-T interval of 350 ms.

Pace pulse

Pace pulses meeting the following conditions are marked by the

PACE indicator.

Pulse indicator

Amplitude:

Width:

Rise time:

±4 to ±700 mV (3/5-lead)

±2 to ±700 mV (12-lead)

0.1 to 2 ms

10 to 100 µs

When tested in accordance with the ANSI/AAMI EC13 Sections

4.1.4.1 and 4.1.4.3, the heart rate meter rejects all pulses meeting

the following conditions.

Pulse rejection

Amplitude:

Width:

Rise time:

Min. input slew rate:

±2 to ±700 mV

0.1 to 2 ms

10 to 100 µs

20 V/s RTI

ST segment measurement

Measurement range -2.0 to +2.0 mV

Precision

-0.8 to +0.8 mV: ±0.02 mV or ±10%, whichever is greater

Beyond this range: Undefined

Update period 10 s

Mortara Software Package

Lead naming style AHA, EURO

The lead resistance is no greater than 51 kΩ and it is in parallel

with a 0.047 µF capacitor, it will not cause a lead fault condition.

Lead fault

Sensitivity selection 1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5),

For 3/5-lead, differential offsets ≤ ±300 mV, it will not cause a

lead fault condition.

For 12-lead, differential offsets ≤ ±500 mV, it will not cause a

lead fault condition.

33

Chapter 3 Product Specifications

10 mm/mV (×1), 20 mm/mV (×2) and AUTO

Sweep speed 12.5 mm/s, 25 mm/s, 50 mm/s

Bandwidth (-3 dB)

Common mode rejection

Diagnostic mode:

Monitor mode:

Surgery mode:

Diagnostic mode:

Monitor mode:

Surgery mode:

0.05 to 150 Hz (M08A module)

0.5 to 40 Hz

1 to 20 Hz

≥90 dB

≥105 dB

≥105 dB

(The notch filter is turned off.)

50/60Hz Notch Filtering The monitor provides software filtering against the 50/60HZ

industrial frequency.

In monitor and surgery modes, the 50/60HZ filter will be turned

on automatically.

In diagnostic mode, the 50/60HZ filter will be turned off.

Input offset current ≤0.1μA (except currents to drive leads)

Differential input impedance ≥ 5MΩ

Input signal range ±8mV (peak-to-peak value)

Accuracy of input signal

reproduction

Auxiliary current (Leads off

detection)

Methods A and D were used to establish overall system error and

frequency response according to EC11.

Active electrode: < 0.1 μA

Reference electrode: < 1 μA

Patient leakage current < 10uA

Recovery time after

defibrillation

Calibration signal

< 5s

1 mV (peak-to-peak value), precision: ±5%

ESU protection Incision mode: 300W

Congelation mode: 100W

Restore time: ≤10s

The monitor complies with the requirements of ANSI/AAMI

EC13 Section 4.2.9.14.

ESU noise control The monitor uses the ECG leads meeting the requirements of

AAMI; based on the ECG baseline, the peak noise ≤ 2 mV

The monitor complies with the test method in EC13 Section

5.2.9.14.

HR

Measurement range

Neonate:

Pediatric:

Adult:

15 to 350 bpm

15 to 350 bpm

15 to 300 bpm

Resolution 1 bpm

Precision ±1 bpm or ±1%, whichever is greater.

Trigger threshold level 200 μV (lead II)

Trigger indication There will be an audible beep on every beat captured.

34

Chapter 3 Product Specifications

Heart Rate Averaging The average Heart Rate is computed in line with the ANSI/AAMI

EC13 Section 4.1.2.1 d) as follows:

The average heart rate is calculated on the basis of the mean

RR-interval of the last 16 beats, unless the heart rate calculated

using the last 4 beats is less than or equal to 48, then this rate is

used.

The displayed Heart Rate is updated once per second.

Heart Rate Meter Accuracy

and Response to Irregular

Rhythm

When tested in accordance with the ANSI/AAMI EC13 Section

4.1.2.1 e), the indicated heart rate after a 20 second stabilization

period is:

Figure 3a (Ventricular Bigeminy) -80±1 bpm

Figure 3b (Slow Alternating Ventricular Bigeminy) -60±1 bpm

Figure 3c (Rapid Alternating Ventricular Bigeminy) -120±1 bpm

Figure 3d (Bi-directional Systoles) -90±2 bpm

Response time to heart rate

changes

Meets the requirement of ANSI/AAMI EC13 Section 4.1.2.1 f).

Less than 11 sec for a step increase from 80 to 120 BPM

Less than 11 sec for a step decrease from 80 to 40 BPM

When tested in accordance with ANSI/AAMI EC13 Section

4.1.2.1 g, the response time is as follows.

Response time of tachycardia

alarm

Figure 4ah – range:

4a – range:

4ad – range:

Figure 4bh – range:

4b – range:

4bd – range:

4.30 to 5.34s, average: 4.75s

3.94 to 5.92s, average: 4.69s

4.28 to 5.18s, average: 4.78s

3.57 to 8.22s, average: 4.83s

3.09 to 4.11s, average: 3.64s

3.20 to 4.52s, average: 4.09s

Tall T-Wave Rejection When tested in accordance with the ANSI/AAMI EC13 Section

4.1.2.1 c), the heart rate meter will reject all T-waves with

amplitudes less than 1.2 mV, 100 ms QRS, a T wave duration of

180ms and a Q-T interval of 350 ms.

Pace pulse

Pace pulses meeting the following conditions are marked by the

PACE indicator.

Pulse indicator

Amplitude:

Width:

Rise time:

±4 to ±700 mV (3/5-lead)

±2 to ±700 mV (12-lead)

0.1 to 2 ms

10 to 100 µs

When tested in accordance with the ANSI/AAMI EC13 Sections

4.1.4.1 and 4.1.4.3, the heart rate meter rejects all pulses meeting

the following conditions.

Pulse rejection

Amplitude:

Width:

Rise time:

Min. input slew rate:

±2 to ±700 mV

0.1 to 2 ms

10 to 100 µs

20 V/s RTI

35

Chapter 3 Product Specifications

ST segment measurement

Measurement range -2.0 to +2.0 mV

Precision

Update period Updated every 16 valid beats

-0.8 to +0.8 mV: ±0.02 mV or ±10%, whichever is greater

Beyond this range: Undefined

3.9. RESP Specifications

Measurement technique Thoracic impedance

Lead Optional: lead I and lead II; default lead II

Respiration excitation

waveform

Respiration impedance test

range

Baseline impedance range 200 to 2500 Ω (using an ECG cable with 1kΩ resistance)

Differential input

impedance

Linear Signal Range 3 Ω p-p minimum

Bandwidth 0.2 to 2 Hz (-3 dB)

Sweep speed 6.25 mm/s, 12.5 mm/s, 25 mm/s

< 300 µA, sinusoid, 62.8 kHz (±10%)

0.3 to 3 Ω

> 2.5 MΩ

RR

Measurement range

Resolution 1 BrPM

Precision

Apnea alarm delay 10 to 40 s

Adult:

Pediatric/neonate:

7 to 150 BrPM:

0 to 6 BrPM:

3.10. SpO2 Specifications

Mindray DS SpO2 Module

All SpO

specifications when used with Mindray DS SpO

SpO2

Measurement range 0 to 100%

Resolution 1%

Precision

Refreshing rate 1 s

sensors specified in the section MindrayDS SpO2 Accessories meets the following

2

module.

2

70 to 100%:

70 to 100%:

0% to 69%:

±2 % (adult/pediatric, non-motion conditions)

±3% (neonate, non-motion conditions)*

Undefined.

0 to 120 BrPM

0 to 150 BrPM

±2 BrPM or ±2%, whichever is greater.

Undefined.

36

Chapter 3 Product Specifications

7 s (When the sensitivity is set to High)

Averaging time

9 s (When the sensitivity is set to Medium)

11 s (When the sensitivity is set to Low)

PR

Measurement range 20 to 254 bpm

Resolution 1 bpm

Precision ±3 bpm (non-motion conditions)

Refreshing rate 1 s

* A study was performed to validate the accuracy of this monitor with 520N SpO2 sensor.

Totally 122 neonates (65 male & 57 female) aged from 1 day to 30 days with a gestation

age of 22 weeks to full term were involved in this study. The statistical analysis of the 200

pairs of data over the range of 72% to 100% SaO2 of this study shows that the accuracy

(Arms) is 2.47 digits, which is within the stated accuracy specification. Another study

performed on adult subjects also shows the effectiveness.

This monitor with 520N SpO2 sensor was validated on adult subjects (1.62% Arms) and

that actual performance in the neonatal population was observed.

Masimo SpO2 Module

All SpO

specifications when used with Masimo SpO

SpO2

Measurement range 1 to 100%

Resolution 1%

Precision

Refreshing rate 1 s

Averaging time

Low perfusion conditions

Low perfusion accuracy ±2%

PR

Measurement range 25 to 240 bpm

Resolution 1 bpm

Precision

Refreshing rate 1 s

sensors specified in the section Masimo SpO2 Accessories meets the following

2

module.

2

70 to 100%:

70 to 100%:

70 to 100%:

0% to 69%:

±2% (adult/pediatric, non-motion conditions)

±3% (neonate, non-motion conditions)

±3% (in motion conditions)

Undefined.

2-4 s、4-6 s、8 s、10 s、12 s、14 s、16 s

Pulse amplitude: >0.02%

Light penetration: >5%

±3 bpm (non-motion conditions)

±5 bpm (in motion conditions)

37

Chapter 3 Product Specifications

Nellcor SpO2 Module

All SpO

specifications when used with Nellcor SpO

sensors specified in the section Nellcor SpO2 Accessories meets the following

2

module.

2

Sensor Range Precision*

SpO2 measurement range

and precision

PR measurement range and

precision

MAX-A, MAX-AL, MAX-N,

MAX-P, MAX-I and MAX-FAST

OxiCliq A, OxiCliq N, OxiCliq P,

OxiCliq I

D-YS, DS-100A, OXI-A/N and

OXI-P/I

MAX-R, D-YSE and D-YSPD

20 to 250 bpm: ±3 bpm

251 to 300 bpm: Undefined

70 to 100%

0% to 69%

70 to 100%

0% to 69%

70 to 100%

0% to 69%

70 to 100%

0% to 69%

±2%

Undefined

±2.5%

Undefined

±3%

Undefined

±3.5%

Undefined

Refreshing rate 1 s

Averaging time 8 s, 16 s

*: When sensors are used on neonatal subjects as recommended, the specified precision range is

increased by ±1%, to account for the theoretical effect on oximeter measurements of fetal

hemoglobin in neonatal blood.

3.11. NIBP Specifications

Measurement technique Auto oscillation

Displayed parameters Systolic pressure, diastolic pressure, mean pressure and PR

Mode of operation Manual, auto and continuous

Measurement interval in

auto mode

Measurement time in

continuous mode

Measurement range in

normal mode

Measurement precision

Resolution 1mmHg

Static pressure

measurement range

Static accuracy ± 3 mmHg

Over-pressure protection Adult: 297±3 mmHg

1/2/3/4/5/10/15/30/60/90/120/180/240/480 minutes

5 minutes

mmHg Adult Pediatric Neonate

Systolic pressure 40 to 270 40 to 200 40 to 135

Diastolic pressure 10 to 210 10 to 150 10 to 100

Mean pressure 20 to 230 20 to 165 20 to 110

Maximum average error: ±5mmHg

Maximum standard deviation: 8mmHg

0 to 300mmHg

38

Chapter 3 Product Specifications

by software Pediatric:

Neonate:

Over-pressure protection

by hardware

Default start pressure

PR from NIBP

Measurement range 40 to 240 bpm

Precision ±3 bpm or ±3%, whichever is greater

Resolution 1 bpm

Adult:

Pediatric:

Neonate:

Adult:

Pediatric:

Neonate:

240±3 mmHg

147±3 mmHg

330 mmHg

330 mmHg

165 mmHg

178±5 mmHg

133±10 mmHg

67±5 mmHg

3.12. TEMP Specifications

Number of channels 2

Displayed parameters T1, T2 and TD

Measurement range

Resolution

Precision

Update period 1s

Minimum time for

accurate measurement

0 to 50°C (32 to 122°F)

0.1°C

±0.1°C (excluding the sensor)

±0.2°C (including the YSI 400 series sensor)

Body surface: < 100s

Body cavity: < 80s

(YSI 400 series sensor)

3.13. IBP Specifications

Number of channels 2

Pressure readings Systolic, diastolic, mean pressures and PR

Pressure labels ART, PA, CVP, RAP, LAP, ICP, P1 and P2

Linear input range

Measurement range

Resolution 1 mmHg

Precision ±2% or ±1mmHg, whichever is greater

Excitation

Update period 1s

Zero offset range ± 200 mmHg

will be -50 to﹢300 mmHg, after zeroing.

ART 0 to 300 mmHg

PA -6 to 120 mmHg

CVP/RAP/LAP/ICP -10 to 40 mmHg

P1/P2 -50 to 300 mmHg

will be 5 Volts DC, ± 2%

Minimum load resistance will be 300Ω per transducer.

39

Chapter 3 Product Specifications

Zero accuracy ± 1 mmHg

Noise <0.5 mmHg RTI, DC to 12.5 Hz, 300Ω source impedance.

Drift

Frequency Response DC-12.5Hz ±1 Hz, -3db

PR from IBP

Measurement range 25 to 350 bpm

Precision 25 to 350 bpm: ±1 or ±1%, whichever is greater.

Resolution 1 bpm

Pressure transducer

Excitement voltage 5 VDC, ±2%

Sensitivity 5 uV/V/mmHg

Impedance range 300 to 3000Ω

Volume displacement

(ABBOTT)

<0.15 mmHg/℃; will not exceed ± 1 mmHg in 24 hours.

＜0.04 mm

3

/100 mmHg

3.14. CO Specifications

Measurement technique Thermal dilution

Calculated parameter CO, hemodynamics

CO 0.1 to 20l/min

Measurement range

Resolution

Precision

Alarm range TB:

TB

TI

CO:

TB, TI:

CO:

TB, TI:

23 to 43°C

0 to 27°C

0.1 l /min

0.1°C

±5% or ± 0.1 l /min

0.1°C

23 to 43°C

3.15. CO2 Specifications

Measurement technique Infrared absorption technique

Displayed parameter EtCO2, FiCO2, Respiration Rate

CO2 function

Meet the requirements of EN ISO21647/ISO 21647 and

ISO9918.

40

Chapter 3 Product Specifications

Mindray DS CO2 Specifications

CO2 measurement range 0 to 99mmHg

0 to 40 mmHg:

Precision*

41 to 76 mmHg:

77 to 99 mmHg:

Resolution 1 mmHg

Drift meet the requirement of accurancy in 6 hours

Sample flow rate 70, 100 ml/min

Precision of deflation rate ±15% or 15 ml/min, whichever is great

Start-up time of CO2

module

< 1min, the module enters the warming up status after the startup.

One minute later, it enters the ready-to-measure status.

AwRR measurement range 0 to 120 BrPM

Precision

0 to 70 BrPM:

> 70 BrPM:

When measured with a neonatal watertrap and a 2.5 m-long

neonatal sampling line:

<3.5 s @ 100 ml/min

Response time

<4 s @ 70 ml/min

When measured with an adult watertrap and a 2.5 m-long adult

sampling line:

<5.5 s @ 100 ml/min

<7 s @ 70 ml/min

When measured with a neonatal watertrap and a 2.5m-long

neonatal sampling line:

<3 s @ 100 ml/min

Delay time

<3.5 s @ 70 ml/min

When measured with an adult watertrap and a 2.5m-long adult

sampling line:

<5 s @ 100 ml/min

<6.5 s @ 70 ml/min

Apnea alarm delay AwRR: 10 to 40 s

* Conditions for measurements in typical precision:

The measurement is started after the preheating mode of the module;
Ambient pressure: 750 mmHg to 760 mmHg; room temperature: 22℃ to 28℃;

The gas under test is dry, and the balance gas is N2;

The deflation rate is 100 ml/min, the respiration rate is no greater than 50 BrPM, with a

fluctuation less than ±3 BrPM, and the inhale interval/exhale interval is 1:2;

When the working temperature is from 15 to 25 degree, or from 50 to 55 degree, or when the

breath rate is greater than 50Brpm, the measurement precision should meet the requirements of

ISO21647: ±4mmHg (0 to 40mmHg) or ±12% of the reading (41 to 99 mmHg)

±2 mmHg

±5%

±10%

±2 BrPM

±5 BrPM

41

Chapter 3 Product Specifications

Oridion CO2 Specifications

CO2 measurement range 0 to 99mmHg

Precision*

0 to 38 mmHg:

39 to 99 mmHg:

Drift meet the requirement of accurancy in 6 hours

Resolution

Sample flow rate

Waveform:

Value:

7.5

−

50

15

+

ml/min

Initialization time 30 s (typical)

Response time 2.9 s (typical)

Delay time 2.7 s (typical)

AwRR measurement range 0 to 150 BrPM

AwRR measurement

precision

0 to 70 BrPM:

70 to 120 BrPM:

121 to 150 BrPM:

Apnea alarm delay AwRR: 10 to 40 s

* Precision applies for breath rates of up to 80 bpm. For breath rates above 80 bpm, accuracy

complies with EN ISO 21647/ISO 21647/ISO 9918 (4 mmHg or ±12% of reading whichever is

greater) for EtCO2 values exceeding 18 mmHg. To achieve the specified accuracies for breath

rates above 60 breaths/minute, the Microstream® FilterLine H Set for Infant/Neonatal (p/n

006324) must be used.The accuracy specification is maintained to within 4% of the values

indicated in the above table in the presence of interfering gases according to EN ISO

21647/ISO 21647 Section Eleven, Part 101.

±2 mmHg

±5% + 0.08% × (reading - 38 mmHg)

0.1 mmHg

1 mmHg

±1 BrPM

±2 BrPM

±3 BrPM

42

Chapter 3 Product Specifications

3.16. AG Specifications

Measurement technique Infrared absorption

Measurement mode Sidestream

AG functions

Warm-up time

Sampling flow

(sidestream)

Gas type CO2, N2O, O2 (optional), Des, Iso, Enf, Sev, Hal

Measurement range

Resolution

Precision

Meets requirements of ISO9918, ISO11196, EN12598 and

ISO7767

45 seconds (warming-up status)

10 minutes (ready-to-measure status)

Adult/Pediatric 120, 150, 200 ml/minute (user-selectable)

Neonatal 70, 90, 120 ml/minute (user-selectable)

CO2:

N2O:

Des:

Sev:

Enf, Iso, Hal:

O2:

AwRR:

CO2:

AwRR:

Gas Range (%REL) Precision (%ABS)

CO2

N2O

Des

Sev

Enf, Iso, Hal

0 to 30%

0 to 100%

0 to 30%

0 to 30%

0 to 30%

0 to 100%

2 to 100 BrPM

1 mmHg

1 BrPM

0 to 1

1 to 5

5 to 7

7 to 10

> 10 Not specified

0 to 20

20 to 100

0 to 1

1to 5

5 to 10

10 to 15

15 to 18

>18 Not specified

0 to 1

1 to 5

5 to 8

> 8 Not specified

0 to 1

1 to 5

±0.1

±0.2

±0.3

±0.5

±2

±3

±0.15

±0.2

±0.4

±0.6

±1

±0.15

±0.2

±0.4

±0.15

±0.2

43

Chapter 3 Product Specifications

> 5 Not specified

0 to 25

O2 (Optional)

25 to 80

80 to 100

AwRR

2 to 60 BrPM

> 60 BrPM Not specified

Drift meet the requirement of accurancy in 6 hours

Alarm range

CO2:

AwRR:

0 to 10 % (0 to 76 mmHg)

2 to 100 BrPM

Apnea alarm delay AwRR: 20 to 40 s

Refreshing rate 1s

Calibration Yearly calibration requested.

Calibration stability

Rise time (10 % to 90 %)

Sampling flow 120ml/min,

using the DRYLINE™

water trap and neonatal

DRYLINE™ sampling

After module being used for 12 consective months, the error is <

1%

CO2 250 ms (fall time 200 ms)

N2O 250 ms

O2 600ms

HAL, ISO, SEV, DES 300 ms

ENF 350 ms

line (2.5m)

Rise time (10 % to 90 %)

Sampling flow 200ml/min,

using the DRYLINE™

water trap and adult

DRYLINE™ sampling

CO2 250 ms (fall time 200 ms)

N2O 250 ms

O2 500ms

HAL, ISO, SEV, DES 300 ms

ENF 350 ms

line (2.5m)

Delay time < 4s

±1

±2

±3

±1 BrPM

44

Chapter 4 Disassembling/Assembling & Troubleshooting

Chapter 4 Disassembling/Assembling &
Troubleshooting

4.1 DPM5 Disassembling/Assembling

4.1.1 Exploded View of DPM5

Figure 4-1 Exploded view of DPM5

NO Material code Part & Specification Quantity

1 9201-30-35947 Front cover assembly 1

2 9210-30-30181 Back plate assembly 1

3 M04-000305--- Cross-head self-tapping screw 3*12 5

4 M02-000802--- Flat washer GB97.13 4

5 9201-30-35944 Support assembly (Lithium battery) 1

6 9201-20-35971- Battery door 1

7 M04-003105--- Cross-head self-tapping screw M3*8 3

8 9201-30-35948 6pin parameter socket 1

9 9201-30-35992 Back cover assembly (microstream CO2) 1

10 TR6C-30-19654 TR6D-C recorder 1

11 M04-004012--- Gasketed cross-head screw M3*6 2

12 M04-004014--- Gasketed cross-head screw M4*10 4

13 M04-004017--- Gasketed cross-head screw M3*12 2

14 M04-051140--- Screw assembly M3*8 2

45

Chapter 4 Disassembling/Assembling & Troubleshooting

4.1.2 DPM5 Display (TFT Display) Assembly

Figure 4-2 DPM5 display (TFT display) assembly

NO Standard Name & Specification Quantity

1

2

3

4

5

6

7

8

M04-004015---

0010-10-12271 LG display LB121S02 1

9210-20-30180 12.1`back plate-LG 1

9210-30-30169 LVDS-TTL adapter board 1

M04-002505--- Cross-head screw M3*6 2

9000E-10-04913 INVERTOR-TDK 2

M04-002405--- Cross-head screw M2*6 4

M90-000002-01 Insulating washer Ф2.5 4

Cross-head screw M3×8

4

46

Chapter 4 Disassembling/Assembling & Troubleshooting

4.1.3 DPM5 Support Assembly (Lithium Battery) (9201-30-35944)

Figure 4-3 DPM5 support assembly

NO Material Code Part & Specification Quantity

1 M04-004012--- Gasketed cross-head screw M3*6 24

2 9200-20-10689 Recorder regulating panel 1

3 M04-005005--- Cross-head sunk screw M3*6 14

4 9201-20-35965 Support 1

5 M04-002505--- Cross-head screw M3*6 10

6 9210-30-30150 9210 main control board 1

7 9201-30-35922 Battery compartment assembly (Lithium

1

battery)

8 M05-010001-06 Lithium battery 2

9 9200-20-10516 Insulating plate of ECG board 1

10 051-000007-00 812B ECG board 1

11 M04-060009--- Stud M3*14 1

12 9200-20-10677 Insulating plate of mounting plate 3 1

13 9200-20-10676 SPO2/IBP mounting plate 1

14 9200-20-10678 Insulating plate of mounting plate 4 1

15 M03A-30-26050 IBP/CO module 1

16 630D-30-09121 630D blood pressure pump 1

17 0010-10-12275 MASIMO SpO2 module 1

18 9201-20-36012 Power PCB insulating plate 1

19 9201-30-35901 Lithium battery power PCB 1

47

Chapter 4 Disassembling/Assembling & Troubleshooting

20 9210-30-30163 Socket assembly 1

21 9201-30-35908 Microstream CO2 adapter board 1

22 9201-30-35955 Microstream CO2 module 1

23 9201-20-35928 Mounting plate of microstream CO2

module

1

4.1.4 Front Cover Assembly

Figure 4-4 Front cover assembly

NO Material Code Part & Specification

1

2

3

4

5

6

7

8

9

10

11

12

13

9200-20-10513 Dust washer 1

9200-20-10514 Dust washer 2

M04-003105--- Cross-head self-tapping screw 3*8

9200-30-10701 Alarm indicator panel (red-yellow indicator)

9200-30-10470 Encoder plate

9201-20-35966 Front screen

9200-20-35968 Alarm indicator cover

9200-20-10548 12.1 TFT panel

9201-20-35972 Rotary knob

9200-20-10512 Foot plate 2

9200-20-10472 Button

9200-20-10473 Button backer

9201-20-36031 Connector

48

Chapter 4 Disassembling/Assembling & Troubleshooting

14

15

M04-051004--- Cross-head self-tapping screw 2.6*6

9201-30-35912 9201 button panel

4.1.5 Back Cover Assembly

Figure 4-5 Back cover assembly (microstream CO2) (9201-30-35992)

NO Material Code Part & Specification Remark

1

2

3

4

5

6

7

8

9

10

11

12

13

14

M04-003105--- Cross-head self-tapping screw 3*8

9200-20-10620 Speaker press plate

9200-21-10633 Speaker

9200-20-10622 Hook mounting plate

9201-21-35974 Back cover (microstream CO2 module)

9201-20-35970 Handle

9201-20-35969 Gland

M04-000802--- Flat washer GB9713

M04-000305--- Cross-head self-tapping screw 3*12

9201-30-35923 Mounting assembly of microstream CO2

connector

6200-20-11614 CO2 nozzle

9200-20-10511 Foot plate 1

M04-000501--- Stainless steel nut GB6170MS

9201-30-35978 Fan assembly

49

Chapter 4 Disassembling/Assembling & Troubleshooting

4.1.6 Microstream CO

Assembly

2

Figure 4-6 Microstream CO

assembly

2

NO Material Code Part & Specification

1

2

3

4

9201-30-35959 Microstream CO2 connector

M04-003105--- Cross-head self-tapping screw 3*8

9201-20-36010 Baffle of torsional spring

9201-20-35961 Retaining torsional spring of microstream CO2

connector

5

9201-20-35915 Mounting plate of CO2 connector

6 9201-20-35914 Baffle of CO2 connector

50

Chapter 4 Disassembling/Assembling & Troubleshooting

4.2 Troubleshooting

4.2.1 Black Screen, Startup Failure

Y

Figure 4-7

Location flow of faults causing black screen

51

Chapter 4 Disassembling/Assembling & Troubleshooting

4.2.2 White Screen & Other Abnormal Screen

In case of faults causing white screen or other abnormal screens,

■ Check whether the LCD connection wires are in good contact;

■ Replace the LCD connection wires, or replace the LCD if necessary;

■ Replace the main control board if the fault still exists.

4.2.3 Encoder Faults

1. If all other functions (indicator, alarm, buttons) of the button panel are normal,

proceed to step 2; otherwise, replace the button panel;

2. Check whether short-circuit or abnormal open-circuit occurs in the encoder pad;

3. Replace the encoder.

4.2.4 No Audio Alarm

1. Check whether the audio alarm function is disabled in the software settings;

2. Replace the speaker;

3. Replace the button panel.

4.2.5 Printing Failure

1. Check whether there is any alarm about the recorder. If any, eliminate it;

2. Check whether the recorder indictor is on;

3. If not, check the connection wire for inputting signals to the recorder;

4. Check whether the recorder module is enabled in the maintenance menu;

5. Check the power cord of the recorder (including the recorder power PCB);

6. Replace the recorder module.

4.2.6 Abnormal Paper Drive

1. Check whether there are blocks on the paper roller of the recorder;

2. Check whether there are blocks in the gear cluster of thermal assembly of the

recorder;

3. Check whether the voltage input of the recorder is larger than 17.6V.

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Chapter 5 Test and Material List

Chapter 5 Test and Material List

5.1 Test Procedure

5.1.1 Connection and Checking

Connect the simulators, power supply and test fixture properly to the DPM5 patient

monitor, and power it on. Then, the patient monitor displays the start-up screen on the TFT

screen and enters the system screen.

5.1.2 Functions of Buttons

Press every button on the button panel to check their functions as specified in DPM5
Operator’s Manual. Rotate the control knob to check its functions.

5.1.3 ECG/RESP

The TFT screen displays the standard ECG waveform, and the error between the heart

rate and the set value of the simulator is no more than ±1, namely 60±1; the RESP

waveform is smooth, and the respiration rate is 20±1.

1. Select all leads in order, including Cal, select all the four gains and AUTO, ensure

the waveforms are displayed properly, and check whether the 50Hz/60Hz

interference can be filtered.

2. Check, in all the above-mentioned cases, the consistency between the

heartbeats, the flashes of the red heart-like indicator, and the R-wave.

3. The gain has no impact on the message “ECG signal over weak” in the HR

calculation.

4. Verify the range and precision: Suppose that the amplitude of the GCG signal of

the simulator is 1mV, the heart rates are respectively 30, 60, 120, 200, 240 and

300. Check leads I, II and III. The results should meet 29-31, 59-61, 119-121,

198-202, 238-242, and 297-303.

5. PACE pulse test: Set the simulator to PACE. You should be able to view the pace.

Change PACE amplitude to ±8 – 700mv, and pulse width to 0.1ms – 2ms. The

PACE should be legible, and LEAD OFF is displayed properly.

6. RESP measurement: Set the baseline impedance to 1K, the respiration

impedance to 0.5Ω and 3Ω, and the respiration rate to 30 and 120. The

respiration rate should be 29 – 31, 118 –122.

7. PVC test: Set the simulator to the PVC mode, and set the occurrence times. The

relevant PVCS should be obtained.

8. Set the simulator as follows: RR: 40, baseline impedance: 2KΩ, RESP waveform:
3:1. Open the apnea alarm, set the respiration resistance to 0Ω, and set various

alarm time. Alarms should be given.

5.1.4 Temperature

1.

YSI probe

Select YSI probe from the manufacturer menu, select YSI temperature probe as

the test fixture, set the analog resistance to 1.471K, 1.355K and 1.249K. Then

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Chapter 5 Test and Material List

the TEMP parameter should be 35±0.1 , 37±℃ 0.1 and 39±0.1 .℃℃

2. CY-F1 probe

Select CY-F1 probe from the manufacturer menu, select CY-F1 temperature

probe as the test fixture, set the analog resistance to 6.534K, 6.018K and

5.548K. Then the TEMP parameter should be 35±0.1 , 37±0.1 and ℃℃
39±0.1 .℃

5.1.5 NIBP

Connect the NIBP simulator, adult cuff and accessories, and then connect the module

CUFF and clockwise screw it tightly.

1. After the simulator self-test, press <ENT> to enter the ADULT analog blood

pressure mode. Set the blood pressure to the 255/195/215 mmHg level, SHIFT

to +15, and the HR to 80BPM. Set DPM5 to the adult mode. Press <START>.

Then the results will be obtained in about 30s. The measured results should be

respectively 270±8mmHg, 210±8mmHg and 230±8mmHg.

2. Press <ESC> and <↓> on the simulator to enter the NEONATE mode. Set the

blood pressure to the 120/80/90 mmHg level, HR to 120bmp, and DPM5 to the

pediatric mode. Press <START>. Then the results will be obtained in about 30s.

The measured results should be respectively 120±8mmHg, 80±8mmHg and

90±8mmHg.

3. Press <ESC> and <↓> on the simulator to enter the NEONATE mode. Set the

blood pressure to the 60/30/40 mmHg level, SHIFT to -20, HR to 120bmp, and

DPM5 to the neonate mode. Change the simulator accessory to the neonatal

cuff. Press <START>. Then the results will be obtained in about 30s. The

measured results should be respectively 40±8mmHg, 10±8mmHg and

20±8mmHg.

5.1.6 SpO2

Select PLETH as the HR source of DPM5, and put the finger into the SpO2 sensor. The

screen should display the PR and SpO

values normally. The normal SpO2 value is

2

above 97%.

5.1.7 IBP

Test fixture

1.

Physiological signal simulator

2. Test procedure
IBP1 test:①

Set the BP sensitivity of the ECG simulator to 5uv/v/mmHg, BP to 0mmHG, and the

IBP channel 1 to ART. Enter the IBP PRESSURE ZERO menu of the DPM5, zero

Channel 1, and then return to the main screen. Set the BP of the simulator to

200mmHg. Enter the IBP PRESSURE CALIBRATE menu of the DPM5, conduct

calibration, and then exit the IBP PRESSURE CALIBRATE menu.

Set the BP value of the simulator respectively to 40mmHg, 100mmHg and

200mmHg. Then the screen of the DPM5 should display 40±1mmHg, 100±2mmHg

and 200±4mmHg.

Set the simulator output to ART wave. Then the screen of the DPM5 should display

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Chapter 5 Test and Material List

relevant waveform properly.

Unplug the IBP probe. Then the screen should prompt “IBP: Transducer 1 OFF!”

and “IBP: Transducer 2 OFF!”

Plug the OHMEDA cable to the IBP1 channel. Then the prompting message “IBP:

Transducer 1 OFF!” disappears.

IBP2 test:②

Plug the IBP cable to the IBP2 channel, and repeat the procedure in Section .①

5.1.8 CO

Test fixture

1.

Physiological signal simulator

2. Test procedure

Injectate and blood temperature test: Assemble the TB and TI test fixture, output
three TB temperature values: 36 , 37 and 38 . Then TB should be respectively ℃℃ ℃

36.0±0.1 , 37.0±0.1 and 38.℃℃0±0.1 . Set the injectate switch to ON, output two ℃
TI temperature values: 0 and 2 . Then the screen should display 0±0.1 and ℃℃ ℃

2.0±0.1 .℃

CO measurement: Set the CO.CONST and T

to the default values: 0.542 and 0 , ℃

I

set the injectate switch to OFF, and then press START. Then the simulator will
output 0 , 2.5L/M and 0 , 5L/M within 2s. The CO values should be 2.5±0.25L/M ℃℃

and 5±0.5L/M.

5.1.9 CO2

Test fixture

1.

CO

steel bottle (containing 10% CO2)

2

2. Test procedure
① Sidestream CO

measurement: Set the calculation compensation of DPM5 to

2

COMMON.

Plug the water trap to the water trap socket, connect the sampling tube with the CO

steel bottle, and open//close the valve of the CO

3s. The CO

value should be the calibration gas pressure value: 76±5%mmHg. When

2

steel bottle based on the interval of

2

the valve is opened permanently, the patient monitor prompts “APNEA ALARM”.

Unplug the water trap. The patient monitor prompts “CO

water trap OFF”. Plug the

2

water trap again. The prompting message disappears.

② When the measured value exceeds the high limit of CO

prompts “CO

than the low limit, the patient monitor prompts “CO

too high” on the main screen. When the measured value is lower

2

too low”.

2

, the patient monitor

2

5.1.10 Water trap

1. Connect the airway and block the inlet of the sampling line with your finger.

Check if the message

CO2 SAMPLE LINE ABNORMAL is displayed and the current

2

pump rate in the CO2 USER MAINTAIN menu drops below ５ml/min. If yes, it

indicates the airway is normal. Otherwise, proceed with step 2.

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Chapter 5 Test and Material List

2. Remove the sampling line and block the inlet of the water trap with your finger.

Check if the message

CO2 SAMPLE LINE ABNORMAL is displayed and the current

pump rate in the CO2 USER MAINTAIN menu drops below ５ml/min. If yes, it

indicates there may be a problem with the connection between the sampling

line and water trap or a leakage in the sampling line. Otherwise, proceed with

step 3.

3. Remove the water trap and block the two inlets in the receptacle for the water

trap. Check if the message

CO2 SAMPLE LINE ABNORMAL is displayed and the

current pump rate in the CO2 USER MAINTAIN menu drops below ５ml/min. If

yes, it indicates there may be a problem with the connection between the water

trap and its receptacle or a leakage in the water trap. Otherwise, there may be a

problem with the internal airway in the monitor. The internal airway has two

parts, one part in the receptacle and the other part in the module. Block the

small tubes between the water trap receptacle and module with your fingers and

check if the message

CO2 SAMPLE LINE ABNORMAL is displayed and the current

pump rate in the CO2 USER MAINTAIN menu drops below ５ml/min. If yes, it

indicates there is a problem with the airway in the receptacle. Replace the

receptacle. Otherwise, replace the module.

5.1.11 Recorder

1. Print the ECG waveform. The recorder should print it normally and clearly. Set

the recorder to the fault of lack of paper and abnormal clip. There should be relevant

prompting messages on the main screen. When the fault is cleared, the patient

monitor should become normal.

2. Print the alarm messages of all parameters. Set the alarm print switch to ON for

all parameters, and set different alarm limits. Then the recorder should print the

alarm message in case of an alarm

5.1.12 Power Supply

When the patient monitor is supplied with the external AC power, the CHARGE

indicator becomes ON. When it is disconnected from the external AC power, the

CHARGE indicator becomes OFF. After the patient monitor is started without

assembling the batteries, “x” is displayed in the battery indication frame on the main

screen. After the batteries are assembled, the battery electricity is displayed in the

battery indication frame on the main screen. The patient monitor can work normally

with or without batteries. It, however, should give an alarm when the batteries are

exhausted.

.

5.1.13 Clock

Verify the correctness of the clock in the system test, and then set the clock to the current time.

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Chapter 5 Test and Material List

5.1.14 System Test

Load all parameters, and conduct operations respectively on the loaded parameters.

During the synchronization, no exceptions (for example, mutual interference) occur.

Set all parameter setups in menus to the default values which are those at the time of

software loading, and conduct operations on the menus, for example, managing the

patient information, recalling data, and so on. All the operations should be done

normally, and the corresponding functions should be correct and meet the product

requirements.

5.2 NIBP Calibration

Figure 5-1 NIBP Calibration

Calibration method:

Based on the precision of 50mmHg (6.7kPa), increase the pressure step by step. The

maximum error at any pressure point within the NIBP measurement range of the patient

monitor should be no more than ±3mmHg (±0.4kPa). Decrease the pressure step by step.

The maximum error at any pressure point within the NIBP measurement range of the patient

monitor should be no more than ±3mmHg (±0.4kPa).

5.3 IBP CALIBRATE

5.3.1 IBP Transducer Zero

 Press the ZERO button on the IBP module to call up IBP PRESSURE ZERO menu as

shown below:

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Chapter 5 Test and Material List

Figure 5-2 IBP PRESSURE ZERO

Zero Calibration of Transducer

Select CH1, the system will zero IBP1. Select CH2, the system will zero IBP2.

Cautions:( Use the PM-6000 IBP module as a example)

 Turn off patient stopcock before you start the zero procedure.
 The transducer must be vented to atmospheric pressure before the zero procedure.
 The transducer should be placed at the same height level with the heart, approximately

mid-axially line.

 Zero procedure should be performed before starting the monitoring and at least once a

day after each disconnect-and-connect of the cable.

Figure 5-3 IBP Zero

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Chapter 5 Test and Material List

5.3.2 IBP Calibration

 Press CAL button on the IBP module to call up the IBP PRESSURE CALIBRATE menu as

shown below:

Figure 5-4 IBP Calibration Menu

Calibrate the transducer:

Turn the knob to select the item CH1 CAL VALUE, press and turn the knob to select the

pressure value to be calibrated for channel 1. Then turn the knob to select the item

CALIBRATE to start calibrating channel 1.

Turn the knob to select the item CH2 CAL VALUE, press and turn the knob to select the

pressure value to be calibrated for channel 2. Then turn the knob to select the item

CALIBRATE to start calibrating channel 2.
 The pressure calibration of DPM5:

Figure 5-5 IBP Calibration

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Chapter 5 Test and Material List

You will need the following pieces of equipment:

• Standard sphygmomanometer

• 3-way stopcock

• Tubing approximately 25 cm long

The Calibration Procedure:

1. Close the stopcock that was open to atmospheric pressure for the zero calibration.

2. Attach the tubing to the sphygmomanometer.

3. Ensure that connection that would lead to patient is off.

4. Connect the 3-way connector to the 3-way stopcock that is not connected to the patient

catheter.

5. Open the port of the 3-way stopcock to the sphygmomanometer. .

6. Select the channel to be calibrated in the menu and select the pressure value to which the

IBP is to be adjusted.

7. Inflate to make the mercury bar rise to the setup pressure value.

8. Adjust repeatedly until the value in the menu is equal to the pressure value shown by the

mercury calibration.

9. Press the Start button, the device will begin calibrating.

10. Wait for the calibrated result. You should take corresponding measures based on the

prompt information.

11. After calibration, disassemble the blood pressure tubing and the attached 3-way valve.

Calibration completion message:

“SUCCESSFUL CALIBRATE”

5.4 CO2 CHECK

Check procedure for sidestream module only

Via the DPM5’s system and maintain menus you are prompted for a password for entering the

factory key. After entering the password “332888” you get access to the pump rate settings and

to check the accuracy of the CO2 measurement. Using the below test set up to verify the

accuracy of the CO2 module.

Figure 5-6 Sidestream test set up

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Chapter 5 Test and Material List

Note The sidestream module can not be calibrated. Only the overall performance

and accuracy is checked. If the Co2 module fails the tests it should be replaced.

Figure 5-7 Factory Maintain Menu Figure 5-8 CO2 check menu

5.5 AG CALIBRATE

Calibrate the AG module every year or when the measured value has a great deviation.

Tool s requ ired:

Gas bottle, with a certain standard gas or mixture gas. Gas concentration should meet the

following requirements: AA>1.5%, CO

>1.5%, N2O>40%, O2>40%, of which AA

2

represents an anesthetic agent.

T-shape connector

Tubing

Reservoir bag

Follow this procedure to perform a calibration:

1. Select MAINTAIN>> in SYSTEM MENU, enter USER KEY, then select CONFIRM

button. Then selecting GAS CALIBRATE >> in USER MAINTAIN menu opens the

GAS CALIBRATE menu.

2. Select VERIFY ACCURACY to check the airway and make sure that there are no

occlusions or leaks.

 Vent the tubing to the air and check if the CUR RATE and SET RATE are

approximately the same. If the deviation is great, it indicates that there is an

occlusion in the tubing. Check the tubing for an occlusion.

 The CUR RATE shall fall rapidly and the system prompt that the tubing is blocked.

Otherwise, it indicates that there are leakages in the tubing. Check the tubing for

leakages.

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Chapter 5 Test and Material List

3. Connect the gas bottle, reservoir bag and the tubing using a T-shape connector as shown

in the figure below. Check the airway and make sure there are no leaks.

4. Open the gas valve and vent a certain standard gas or mixture gas into the tubing.

Gas valve

Tubing

AG module

Reservoir bag

Gas bottle

5. In the CALIBRATE menu, the concentration and flowrate of each measured gas are

displayed

 If the difference between the measured gas concentration and the actual one is very

small, a calibration is not needed.

 If the difference is great, you should perform a calibration. Select START CAL>>

to enter the calibrate menu.

6. Enter the vented gas concentration. If you use only one gas for calibration, set other

gases’ concentration to 0.

7. Select CALIBRATE to start calibration.

8. If the calibration is finished successfully, the message CALIBRATION COMPLETED!

is displayed. If the calibration failed, the message AG CAL. FAILED is displayed.

Perform another calibration.

9. Select EXIT to exit the current menu.

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Chapter 5 Test and Material List

5.6 DPM5 Material List

NO Material Code` Name & Specification Quantity

1 M04-004012--- Gasketed cross-head screw M3*6 24

2 9200-20-10689 Recorder regulating panel 1

3 M04-005005--- Cross-head sunk screw M3*6 14

4 9201-20-35965 Support 1

5 M04-002505--- Cross-head screw M3*6 10

6 9210-30-30150 9210 main control board 1

7 9201-30-35922 Battery compartment assembly (Lithium

battery)

8 M05-010001-06 Lithium battery 2

9 9200-20-10516 Insulating plate of ECG board 1

10 812A-30-08557 812A ECG board 1

11 M04-060009--- Stud M3*14 1

12 9200-20-10677 Insulating plate of mounting plate 3 1

13 9200-20-10676 SPO2/IBP mounting plate 1

14 9200-20-10678 Insulating plate of mounting plate 4 1

15 M03A-30-26050 IBP/CO module 1

16 630D-30-09121 630D blood pressure pump 1

17 0010-10-12275 MASIMO SpO2 module 1

28 9201-20-36012 Power PCB insulating plate 1

29 9201-30-35901 Lithium battery power PCB 1

20 9210-30-30163 Pinboard assembly 1

21 9201-30-35908 Microstream CO2 adapter board 1

22 9201-30-35955 Microstream CO2 module 1

23 9201-20-35928 Mounting plate of microstream CO2

module

1

1

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Chapter 5 Test and Material List

FOR YOUR NOTES

64

Chapter 6 Maintenance and Cleaning

Chapter 6 Maintenance and Cleaning

6.1 Maintena nce

6.1.1Checking Before Using

■ Check the patient monitor for mechanical damages;

■ Check all exposed conductors, connectors and accessories;

■ Check all functions that are possibly enabled for the monitored patient, and

ensure the device is in good working status.

In case of any damage, stop using this patient monitor, and contact biomedical

engineers of the hospital or Mindray DS maintenance engineers.

6.1.2 Regular Checking

An all-around check, including the safety check, should be done by qualified personnel

every 6-12 months or after maintenance each time.

All checks in which the patient monitor should be disassembled should be done by

qualified maintenance personnel. The safety and maintenance checks can be done by

Mindray DS engineers. The local office of Mindray DS at your region will be pleased to

provide you with the information about the maintenance contract.

6.2 Cleaning

Do switch off the patient mon itor and d isconn ect the AC power supply before
cleaning it or the probes.

The DPM5 patient monitor should be dust free. To clean the surface of its enclosure

and screen, use the cleaning agent that is not corrosive, for example, soap and water.

1. Do not use strong solvent, such as acetone;

2. Most cleaning agents must be diluted before being used, so conduct dilution under

the instruction of manufacturers;

3. Do not use any erosive material (such as steel wool or polishing agent);

4. Prevent the ingress of any liquid to the enclosure and any part of the device;

5. Ensure no residue of cleaning liquid on the surface of the device.

6.3 Cleaning Reagent

1. Diluted aqua ammonia

2. Diluted sodium hypochlorite (bleaching powder for washing)

3. Diluted formaldehyde 35 – 37%

4. Hydrogen peroxide 3%

5. Ethanol

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Chapter 6 Maintenance and Cleaning

6. Isopropyl alcohol

6.4 Sterilization

To avoid the long-time damage to the patient monitor, we recommend you
9 To conduct only sterilization which is considered necessary in your maintenance

plan;

9 To clean the patient monitor before the sterilization;
9 To sterilize the patient monitor with specified sterilization agent: Ethylate, and

Acetaldehyde.

For the sterilization agents of the ECG leads and blood pressure cuffs, refer to relevant

chapters in Operation Manual.

Caution





Conduct dilution or use the liquid of the possibly-lowest concentration
under the instructions by the manufacturer.

Prevent the ingress of liquid to the enclosure.







Prevent any part of the system from being dipped.
In sterilization, do not spill the liquid to the patient monitor.
Ensure no residue of sterilization agent on the surface of the patient

monitor. Clean it if any.

6.5 Disinfection

To avoid the long-time damage to the patient monitor, we recommend you
9 To conduct only disinfection which is considered necessary in your maintenance

plan;

9 To clean the patient monitor before the disinfection;

For the disinfections of ECG leads, SpO

sensor, refer to relevant chapters in Operation Manual.

Gas (EtO) or formaldehyde are forbidden for the disinfection of the patient
monitor.

sensor, blood pressure cuffs and temperature

2

66

Mindray DS USA, Inc.

800 MacArthur Blvd.

Mahwah, New Jersey 07430

USA

Tel:[phone]

Tel:[phone]

www.mindray.com

P/N: 046-000183-00(3.0)