Mindray DPM 5 Service manual

Service Manual (V 5.0)

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Mindray DS USA, Inc. (hereinafter called Mindray DS) owns all rights to this unpublished work and intends to maintain this work as confidential. Mindray DS may also seek to maintain this work as an unpublished copyright.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

All information contained in this manual is believed to be correct. Shenzhen Mindray Bio-Medical

Electronics Co., Ltd. shall not be liable for errors contained herein nor for incidental or consequential damages in c onnection with the f urnishing or use of th is manual.

The manufacturer 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 qualified personnel;

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

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

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Warning

For continued safe use of this equipment, it is necessary that the listed instructions are followed. However, instructions listed in this manual in no way supersede established medical practices concerning patient care. z Do not rely only on audible alarm system to monitor patient. When monitoring

adjusting the volume to very low or completely muting the sound may result in the disaster to the patient. The most reliable way of monitoring the patient is at the same time of using monitoring equipment correctly, manual monitoring should be carried out.

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

professionals in health care institutions.

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

carried out by qualified personnel.

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

interfering signal on the screen of ultrasonic imaging system. Keep the distance between the monitor and the ultrasonic imaging system as far as possible.

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

other liquid or conductive adhesive. Electrical contact and coupler such as cable connector, power supply and parameter module socket-inlet and frame must be kept clean and dry. Once being polluted by liquid, they must be thoroughly dried. If to further remove the pollution, please contact your biomedical department or

Mindray DS.

It is important for the hospital or organization that employs this equipment to carry out a reasonable maintenance schedule. Neglect of this may result in machine breakdown or injury of human health.

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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 '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 or repaired by anyone other than a Mindray authorized representative.

This warranty shall not extend to any instrument which has been subjected to misuse, negligence or accident; any instrument from which Mindray '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 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.

■ 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 5.0)

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:

Address:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Mindray Building, Keji 12th Road South,Hi-tech industrial park,

Nanshan, Shenzhen 518057,P.R.China

Website: www.mindray.com

E-mail Address

Tel:

Fax: [email protected]

+86 755 81888998

+86 755 26582680

Distributor:

Address:

Tel:

Mindray DS USA, Inc.

800 MacArthur Boulevard, Mahwah, New Jersey 07430 USA

1.800.288.2121, 1.201.995.8000

Website: www.mindray.com

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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

WARNING

CAUTION

Meaning

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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WARNING:

Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as life-support systems. If this system malfunctions and generates an 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 waves near the system, they must be instructed to immediately turn OFF the device. This is necessary to ensure the proper operation of the system.

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

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Symbols

Be Careful Protective earth ground

Indicates that the instrument is IEC-60601-1 Type CF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation.

Equipotential grounding terminal

Silence Symbol ！ Close all alarm volume

@ Mark Event 》 Next menu

*** Highest level alarm ** Middle level alarm

* Lowest level alarm pause

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

Heart beat Pace signal

× Gain magnify √ Confirm

SN Series Number

VII

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Contents

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

1.1

I

NTRODUCTION

................................................................................................................................1

1.2

A

PPLICATION

...............................................................................................................................1

1.2.1

General ...............................................................................................................................1

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

2.1

G

ENERAL

...........................................................................................................................................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

H

ARDWARE

D

ESCRIPTION

..........................................................................................................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

SpO

2

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

S

OFTWARE

D

ESCRIPTION

........................................................................................................18

2.3.1

General .............................................................................................................................18

2.3.2

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

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

2.4

S

YSTEM

P

ARAMETER

................................................................................................................21

2.4.1

General .............................................................................................................................21

2.4.2

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

2.4.3

NIBP .................................................................................................................................22

2.4.4

SpO

2

..................................................................................................................................23

2.4.5

TEMP................................................................................................................................23

2.4.6

IBP ....................................................................................................................................23

2.4.7

CO.....................................................................................................................................24

2.4.8

CO

2

...................................................................................................................................24

2.4.9

AG .....................................................................................................................................24

CHAPTER 3.

PRODUCT SPECIFICATIONS...............................................................................27

3.1.

S

AFETY

C

LASSIFICATIONS

........................................................................................................27

3.2.

E

NVIRONMENTAL

S

PECIFICATIONS

..........................................................................................27

3.3.

P

OWER

S

OURCE

S

PECIFICATIONS

..........................................................................................28

3.4.

H

ARDWARE

S

PECIFICATIONS

...................................................................................................29

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3.5.

W

IRELESS NETWORK

................................................................................................................30

3.6.

D

ATA

S

TORAGE

.........................................................................................................................30

3.7.

S

IGNAL

O

UTPUT

S

PECIFICATIONS

...........................................................................................30

3.8.

ECG S

PECIFICATIONS

..............................................................................................................31

3.9.

RESP S

PECIFICATIONS

............................................................................................................36

3.10.

S

P

O

2

S

PECIFICATIONS

.........................................................................................................36

3.11.

NIBP S

PECIFICATIONS

.........................................................................................................38

3.12.

TEMP S

PECIFICATIONS

.......................................................................................................39

3.13.

IBP S

PECIFICATIONS

............................................................................................................39

3.14.

CO S

PECIFICATIONS

............................................................................................................40

3.15.

CO

2

S

PECIFICATIONS

...........................................................................................................40

3.16.

AG S

PECIFICATIONS

............................................................................................................43

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

4.1

DPM5 D

ISASSEMBLING

/A

SSEMBLING

.....................................................................................45

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

4.1.3 DPM5 Support Assembly (Lithium Battery) (9201-30-35944)......................................47

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

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

4.1.6 Microstream CO

2

Assembly................................................................................................50

4.2

T

ROUBLESHOOTING

..................................................................................................................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

T

EST

P

ROCEDURE

....................................................................................................................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 SpO

2

........................................................................................................................................54

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

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

5.1.9 CO

2

..........................................................................................................................................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 C

ALIBRATION

...................................................................................................................57

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5.3

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

5.4

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

5.5

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

5.6

DPM5 M

ATERIAL

L

IST

..............................................................................................................63

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

6.1

M

AINTENANCE

.................................................................................................................................65

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

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

6.2

C

LEANING

..................................................................................................................................65

6.3

C

LEANING

R

EAGENT

................................................................................................................65

6.4

S

TERILIZATION

..........................................................................................................................66

6.5

D

ISINFECTION

...........................................................................................................................66

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Service Manual (V

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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

DPM5 can be connected with the central monitoring system whereby a monitoring network will be formed. Parameters that the DPM5 can monitor include: ECG, RESP, SpO

2

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

2

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

2

, TEMP, RESP, IBP, CO and

CO

2

physiological signals through the ECG electrode, SpO

2

sensor, cuff, temperature sensor 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.

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

2

, RESP, IBP, CO, CO

2

, TEMP, etc. In recent years, the development of science and technology helping measure and get important physiological information of patients has made the patient monitor more comprehensive in performance and better in quality. Today, multi-parameter patient monitors are widely used.

1

Chapter 1 About the Product

1.2.2 Usage

Parameters that the DPM5 can monitor include: ECG, RESP, SpO

2

, NIBP, TEMP, IBP, CO

AGand CO

2

. DPM5 converts these physiological signals to digital signals, processes them and displays them on the screen. You can set the alarm limit as required. When the monitored parameter exceeds the preset alarm limit, the patient monitor will start the alarm function. In addition, you can control the patient monitor through the control panel. 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)

RESP

SpO

2

NIBP

Respiration Rate (RR)

Respiration waveform

Pulse Oxygen Saturation(SpO

2

), Pulse Rate (PR)

SpO

2

Plethysmogram

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

(NM)

IBP

CO

CO

2

AG

CH1: SYS, DIA

CH2: SYS, DIA

IBP waveform

Temperature of blood (TB)

Cardiac Output (CO)

End-tidal carbon dioxide (EtCO

2

)

Inspired minimum CO

2

(InsCO

2

)

Airway Respiration Rate (AwRR)

Inhaled and exhaled CO

2

(FiCO

2

, EtCO

2

)

2

Chapter 1 About the Product

Inhaled and exhaled N

2

O (FiN

2

O, EtN

2

O)

Inhaled and exhaled O

2

(FiO

2

, EtO

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

2

, N

2

O, O

2

, AA)

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

FOR YOUR NOTES

Chapter 1 About the Product

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

2

, NIBP, TEMP, IBP, CO and CO

2

(IBP, CO and CO

2

are optional). It consists of the following functional parts:

Parameter measurement;

Main control part;

Man-machine interface;

Power supply;

Other auxiliary functions;

These functional units are respectively detailed below.

Figure 2-1 Structure of the DPM5

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)

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.

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.

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.

2.2.1.1 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.

2.2.2.1 General

This module provides the function of measuring three parameters: electrocardiograph (ECG), respiration (RESP) and temperature (TEMP).

9

2.2.2.2 Principle diagram

Chapter 2 Principles

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

2.2.3.1 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 SpO

2

Module

2.2.4.1 General

This module provides the function of measuring the Pulse Oxygen Saturation (SPO

2

).

2.2.4.2 Principle diagram

Figure2-7 Working principle of the SpO

2

module

2.2.4.3 Principle

The SpO

2

measurement principle

1. Collecting the light signal of the red light and infrared transmitting through the finger or toe which is pulsing;

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

The drive circuit of the LED and the gain of the amplifying circuit should be controlled according to the different perfusions and transmittances of the tested object.

Led Drive Circuit

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

SPO2 Signal Process Network

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

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

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

2

parameter;

„ 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.

2.2.5.1 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.

2.2.6.1 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 Detect 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.

2.2.7.1 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.

2.2.8.1 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

NO Task Function

1 System initialization Initializing the system

2

Data processing Analyzing and saving the data

Period

In case of a startup

1 second

3 information

5

Switchover of modules and screens

Switching over between waveforms and parameters on the screen

In case of a screen change event

6

7

Processing of user screens displaying them on the screen.

System monitoring

In case of a button event

System monitoring, voltage monitoring and battery management

1 second

8

Network connection Implementing the network connection

9

Network data sending Sending the network data

1 second

1 second

1 second

10

Network data receiving Receiving the network data (viewbed)

11 ECG analysis

Analyzing ECG signal, calculating ECG values

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

1 second

1 second

12

13

Record output

NIBP processing

14 WATCHDOG task

Outputting records

Implementing NIBP-related processing

Managing the system watchdog

In case of a record event

1 second

1 second

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

2

, ECG/RESP/TEMP, IBP/CO and CO

2

in real time, and send the results to the main 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 SpO

2

The SpO

2

value is obtained through the pulse waves of the finger tips based on specific algorithm and clinical data. The SpO

2

probe is the measurement transducer. It has two 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

2

module is involved in four parts: SpO

2

probe, signal processing 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 CO

2

The CO

2

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

2

module is composed of the circuit board, 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

2

measurement is 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

2

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

FOR YOUR NOTES

Chapter 2 Principles

26

Chapter 3 Product Specifications

Chapter 3. Product Specifications

3.1. Safety Classifications

Type of protection against electric shock

Degree of protection against electric shock

Class I with internal electric power supply.

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:

BF (defibrillation proof)

CF (defibrillation proof)

Degree of protection against hazards of ignition of flammable anesthetic mixtures

Degree of protection against harmful ingress of water

Mode of operation

Equipment type

Not protected (ordinary)

Not protected (ordinary)

Continuous

Portable

3.2. Environmental Specifications

Operating temperature

Operating humidity

Operating altitude

Storage temperature

Storage humidity

Storage and transportation altitude

0 to 40℃

5 to 35℃

(With Sidestream CO2 module)

5 to 35℃ (With Microstream CO2 module)

10 to 35℃ (With AION AG module)

15 to 95%, noncondensing

-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℃

10 to 95%, noncondensing

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

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

Nellcor SpO2 module)

27

Chapter 3 Product Specifications

3.3. Power Source Specifications

AC Power Supply Specifications

Input voltage 100 to 240 V～

Fuse

Internal battery

Number of batteries

Type

Time to shutdown

Sealed lead-acid battery

Nominal voltage

T 3 A, 250 V

2

Sealed lead-acid battery or lithium-ion battery

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

12 VDC

Operating time

Charge time

Lithium battery

Rated voltage

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)

Operating time

Charge time

11.1 VDC

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).

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

28

Chapter 3 Product Specifications

3.4. Hardware Specifications

Physical

Size

Weight

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

Different due to different configurations

Standard configuration: 4.7kg

Maximum weight: ≤ 7.5kg

Display

Type

Size

Color TFT LCD

12.1 inches (diagonal)

Recorder

Type

Horizontal resolution

Thermal dot array

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

LED indicator

Alarm indicator

Running status indicator

AC power indicator

Battery indicator

Audio indicator

1 (yellow and red)

1 (green)

1 (green)

1 (green)

Speaker

Giving audio alarms (45 to 85 dB), keypad tones, and heartbeat/pulse tone.

Supporting PITCH TONE and multi-level volume.

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

Connectors

Power supply

Network

VGA

Auxiliary output

Equipotentiality

1 AC power connector

1 standard RJ45 network connector, 100 BASE-TX

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

1 BNC connector

1 equipotential grounding connector

29

Chapter 3 Product Specifications

3.5. Wireless network

Standards

Frequency range

Operating channel

Safe distance

Maximum data rate

IEEE 802.11b, Wi-Fi compatible

2.412 to 2.462GHz

China America Canada Europe Spain France Japan

1 to 11 10, 11 2

For other country, please refer to your local law.

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

11Mbps

3.6. Data Storage

Trend data

Alarm events

ARR events

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).

80 ARR events and associated waveforms with 8s wavelength.

800 NIBP groups, including systolic pressures, mean pressures, diastolic pressures and measurement time.

3.7. Signal Output Specifications

Standards

Output impedance

Meets the requirements of EC60601-1 for short-circuit protection and leakage current

50Ω

ECG analog output

Bandwidth (-3dB; reference frequency: 10Hz)

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

Maximum propagation delay

Sensitivity

25 ms (In DIAGNOSTIC mode, NOTCH is OFF)

1 V/mV± 5%

PACE rejection/enhancement No pace rejection or enhancement

IBP analog output

Bandwidth

Maximum propagation Delay

Sensitivity

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

55 ms (the filter function is disabled)

1 V/100 mmHg ±5%

Nurse call output

Driver Relay

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

30

Chapter 3 Product Specifications

Conducting resistance

Isolation voltage

Signal type

< 1Ω

> 1500 VAC

Normally open or normally closed, selectable

Defibrillator synchronization pulse

Maximum time delay

Amplitude

Pulse width

Rising and falling time

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

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

100 ms ±10%

< 3 ms

VGA

Connector type 15-PIN D-sub socket

Horizontal/vertical synchronization: TTL level

3.8. ECG Specifications

Mindray DS Software Package

Lead naming style

Lead fault

Sensitivity selection

Sweep speed

Bandwidth (-3 dB)

AHA, EURO

The lead resistance is no greater than 51 k

Ω and it is in parallel with a 0.047 µF capacitor, it will not cause a lead fault condition.

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

12.5 mm/s, 25 mm/s, 50 mm/s

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

Common mode rejection

50/60Hz Notch Filtering

Diagnostic mode:

Monitor mode:

Surgery mode:

≥90 dB

≥105 dB

≥105 dB

(The notch filter is turned off.)

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.

Input offset current

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

≤0.1μA (except currents to drive leads)

Differential input impedance ≥ 5MΩ

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

31

Chapter 3 Product Specifications

Accuracy of input signal reproduction

Auxiliary current (Leads off detection)

Patient leakage current

Recovery time after defibrillation

Calibration signal

ESU protection

ESU noise control

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

< 10uA

< 5s

1 mV (peak-to-peak value), precision:

±5%

Incision mode: 300W

Congelation mode: 100W

Restore time: ≤10s

The monitor complies with the requirements of ANSI/AAMI

EC13 Section 4.2.9.14.

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

Precision

Trigger threshold level

Trigger indication

Heart Rate Averaging

Heart Rate Meter Accuracy and Response to Irregular

Rhythm

Response time to heart rate changes

±1 bpm or ±1%, whichever is greater.

200 μV (lead II)

There will be an audible beep on every beat captured.

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.

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

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

Response time of tachycardia alarm

Tall T-Wave Rejection

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

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

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

Pulse indicator

Pulse rejection

Pace pulses meeting the following conditions are marked by the

PACE 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.

Amplitude: ±2 to ±700 mV

Width:

Rise time:

Min. input slew rate:

0.1 to 2 ms

10 to 100 µs

20 V/s RTI

ST segment measurement

Measurement range

Precision

Update period

-2.0 to +2.0 mV

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

Beyond this range: Undefined

10 s

Mortara Software Package

Lead naming style

Lead fault

Sensitivity selection

AHA, EURO

The lead resistance is no greater than 51 k

Ω and it is in parallel with a 0.047 µF capacitor, it will not cause a lead fault condition.

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),

33

Chapter 3 Product Specifications

Sweep speed

Bandwidth (-3 dB)

Common mode rejection

50/60Hz Notch Filtering

(The notch filter is turned off.)

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)

Patient leakage current

Recovery time after defibrillation

Calibration signal

ESU protection

10 mm/mV (×1), 20 mm/mV (×2) and AUTO

12.5 mm/s, 25 mm/s, 50 mm/s

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

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

< 10uA

< 5s

ESU noise control

1 mV (peak-to-peak value), precision:

±5%

Incision mode: 300W

Congelation mode: 100W

Restore time: ≤10s

The monitor complies with the requirements of ANSI/AAMI

EC13 Section 4.2.9.14.

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

Precision

Trigger threshold level

Trigger indication

±1 bpm or ±1%, whichever is greater.

200 μV (lead II)

There will be an audible beep on every beat captured.

34

Chapter 3 Product Specifications

Heart Rate Averaging

Heart Rate Meter Accuracy and Response to Irregular

Rhythm

Response time to heart rate changes

Response time of tachycardia alarm

Tall T-Wave Rejection

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.

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

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.

Figure 4ah – range:

4a – range:

4.30 to 5.34s, average: 4.75s

3.94 to 5.92s, average: 4.69s

4ad – range:

Figure 4bh – range:

4b – range:

4bd – range:

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

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

Pulse indicator

Pulse rejection

Pace pulses meeting the following conditions are marked by the

PACE indicator.

Amplitude: ±4 to ±700 mV (3/5-lead)

±2 to ±700 mV (12-lead)

Width:

Rise time:

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.

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

Precision

Update period

-2.0 to +2.0 mV

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

Beyond this range: Undefined

Updated every 16 valid beats

3.9. RESP Specifications

Measurement technique

Lead

Respiration excitation

Thoracic impedance

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

Respiration impedance test range

< 300 µA, sinusoid, 62.8 kHz (±10%)

0.3 to 3 Ω

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

Differential input impedance

Linear Signal Range

Bandwidth

Sweep speed

> 2.5 MΩ

3 Ω p-p minimum

0.2 to 2 Hz (-3 dB)

6.25 mm/s, 12.5 mm/s, 25 mm/s

RR

Measurement range

Adult:

Pediatric/neonate:

0 to 120 BrPM

0 to 150 BrPM

Precision

Apnea alarm delay

7 to 150 BrPM:

0 to 6 BrPM:

10 to 40 s

±2 BrPM or ±2%, whichever is greater.

Undefined.

3.10. SpO

2

Specifications

Mindray DS SpO

2

Module

All SpO

2

sensors specified in the section MindrayDS SpO2 Accessories meets the following specifications when used with Mindray DS SpO

2

module.

SpO2

Measurement range 0 to 100%

Resolution 1%

70 to 100%: ±2 % (adult/pediatric, non-motion conditions)

Precision 70 to 100%:

0% to 69%:

±3% (neonate, non-motion conditions)*

Undefined.

Refreshing rate 1 s

36

Chapter 3 Product Specifications

Averaging time

7 s (When the sensitivity is set to High)

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

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 SpO

2

Module

All SpO

2

sensors specified in the section Masimo SpO2 Accessories meets the following specifications when used with Masimo SpO

2

module.

SpO2

Measurement range 1 to 100%

Resolution 1%

Precision

Refreshing rate

Averaging time

70 to 100%:

70 to 100%:

70 to 100%:

0% to 69%:

1 s

Low perfusion conditions

±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%

Low perfusion accuracy ±2%

PR

Measurement range 25 to 240 bpm

Precision

Refreshing rate

±3 bpm (non-motion conditions)

±5 bpm (in motion conditions)

1 s

37

Chapter 3 Product Specifications

Nellcor SpO

2

Module

All SpO

2

sensors specified in the section Nellcor SpO2 Accessories meets the following specifications when used with Nellcor SpO

2

module.

SpO2 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

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

PR measurement range and precision

Refreshing rate

20 to 250 bpm: ±3 bpm

251 to 300 bpm: Undefined

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

Displayed parameters

Mode of operation

Measurement interval in auto mode

Measurement time in continuous mode

Auto oscillation

Systolic pressure, diastolic pressure, mean pressure and PR

Manual, auto and continuous

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

5 minutes

40 to 135

10 to 100

20 to 110

Measurement range in normal mode

Systolic pressure 40 to 270

Diastolic pressure 10 to 210

297±3 mmHg

40 to 200

10 to 150

Mean pressure 20 to 230

Maximum average error:

±5mmHg

20 to 165

Measurement precision

Maximum standard deviation: 8mmHg

Resolution 1mmHg

Static pressure measurement range

0 to 300mmHg

Static accuracy ± 3 mmHg

Over-pressure protection Adult:

38

Chapter 3 Product Specifications by software

Over-pressure protection by hardware

Default start pressure

Pediatric:

Neonate:

Adult:

Pediatric:

Neonate:

Adult:

Pediatric:

Neonate:

PR from NIBP

Measurement range

Precision

40 to 240 bpm

240±3 mmHg

147±3 mmHg

330 mmHg

330 mmHg

165 mmHg

178±5 mmHg

133±10 mmHg

67±5 mmHg

±3 bpm or ±3%, whichever is greater

3.12. TEMP Specifications

Number of channels

Displayed parameters

Measurement range

Resolution

Precision

Update period

Minimum time for accurate measurement

2

T1, T2 and TD

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)

1s

Body surface: < 100s

Body cavity: < 80s

(YSI 400 series sensor)

3.13. IBP Specifications

Number of channels

Pressure readings

Pressure labels

Linear input range

Measurement range

2

Systolic, diastolic, mean pressures and PR

ART, PA, CVP, RAP, LAP, ICP, P1 and P2 will be -50 to﹢300 mmHg, after zeroing.

ART 0 to 300 mmHg

PA

CVP/RAP/LAP/ICP

P1/P2

-6 to 120 mmHg

-10 to 40 mmHg

-50 to 300 mmHg

Precision

Excitation

Update period

Zero offset range

±2% or ±1mmHg, whichever is greater will be 5 Volts DC, ± 2%

Minimum load resistance will be 300Ω per transducer.

1s

± 200 mmHg

39

Zero accuracy

Noise

Drift

Frequency Response

PR from IBP

Measurement range

Precision

Pressure transducer

Excitement voltage

Sensitivity

Impedance range

Volume displacement

(ABBOTT)

Chapter 3 Product Specifications

± 1 mmHg

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

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

DC-12.5Hz ±1 Hz, -3db

25 to 350 bpm

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

5 VDC, ±2%

5 uV/V/mmHg

300 to 3000Ω

＜

0.04 mm

3

/100 mmHg

3.14. CO Specifications

Measurement technique

Calculated parameter

Thermal dilution

CO, hemodynamics

Measurement range

Resolution

Precision

Alarm range

TB

TI

CO:

TB, TI:

CO:

TB, TI:

TB:

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. CO

2

Specifications

Measurement technique Infrared absorption technique

Displayed parameter

CO2 function

EtCO2, FiCO2, Respiration Rate

Meet the requirements of EN ISO21647/ISO 21647 and

ISO9918.

40

Chapter 3 Product Specifications

Mindray DS CO

2

Specifications

CO2 measurement range

Precision*

0 to 99mmHg

0 to 40 mmHg:

41 to 76 mmHg:

77 to 99 mmHg:

±2 mmHg

±5%

±10%

Drift

Sample flow rate meet the requirement of accurancy in 6 hours

70, 100 ml/min

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

Start-up time of CO2 < 1min, the module enters the warming up status after the startup. module One minute later, it enters the ready-to-measure status.

AwRR measurement range 0 to 120 BrPM

Precision

0 to 70 BrPM:

> 70 BrPM:

±2 BrPM

±5 BrPM

Response time

When measured with a neonatal watertrap and a 2.5 m-long neonatal sampling line:

<3.5 s @ 100 ml/min

<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

<3.5 s @ 70 ml/min

Delay time

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

AwRR: 10 to 40 s Apnea alarm delay

* 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)

41

Chapter 3 Product Specifications

Oridion CO

2

Specifications

CO2 measurement range

Precision*

Drift

Resolution

0 to 99mmHg

0 to 38 mmHg:

39 to 99 mmHg:

±2 mmHg

±5% + 0.08% × (reading - 38 mmHg) meet the requirement of accurancy in 6 hours

Waveform: 0.1 mmHg

Value: 1 mmHg

Sample flow rate

50

−

7.5

+

15

ml/min

Initialization time

Response time

Delay time

30 s (typical)

2.9 s (typical)

2.7 s (typical)

AwRR measurement range 0 to 150 BrPM

AwRR measurement precision

Apnea alarm delay

0 to 70 BrPM:

70 to 120 BrPM:

121 to 150 BrPM:

AwRR: 10 to 40 s

±1 BrPM

±2 BrPM

±3 BrPM

* 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.

42

Chapter 3 Product Specifications

3.16. AG Specifications

Measurement technique

Measurement mode

AG functions

Warm-up time

Sampling flow

(sidestream)

Gas type

Measurement range

Resolution

Precision

Infrared absorption

Sidestream

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, O2 (optional), Des, Iso, Enf, Sev, Hal

CO2:

N2O:

Des:

Sev:

Enf, Iso, Hal:

O2:

AwRR:

CO2:

AwRR:

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

CO2

N2O

Des

0 to 1

1 to 5

5 to 7

7 to 10

> 10

0 to 20

20 to 100

0 to 1

1to 5

5 to 10

10 to 15

15 to 18

±0.1

±0.2

±0.3

±0.5

Not specified

±2

±3

±0.15

±0.2

±0.4

±0.6

±1

Sev

Enf, Iso, Hal

0 to 1

1 to 5

5 to 8

> 8

0 to 1

1 to 5

±0.15

±0.2

±0.4

Not specified

±0.15

±0.2

43

Chapter 3 Product Specifications

Drift

Alarm range

Apnea alarm delay

Refreshing rate

Calibration

Calibration stability

Rise time (10 % to 90 %)

Sampling flow 120ml/min, using the DRYLINE™ water trap and neonatal

DRYLINE™ sampling line (2.5m)

Rise time (10 % to 90 %)

Sampling flow 200ml/min, using the DRYLINE™ water trap and adult

DRYLINE™ sampling line (2.5m)

Delay time

O2 (Optional)

AwRR

> 5

0 to 25

25 to 80

80 to 100

2 to 60 BrPM

> 60 BrPM

Not specified

±1

±2

±3

±1 BrPM

Not specified meet the requirement of accurancy in 6 hours

CO2: 0 to 10 % (0 to 76 mmHg)

AwRR: 2 to 100 BrPM

AwRR: 20 to 40 s

1s

Yearly calibration requested.

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

ENF

300 ms

350 ms

CO2

N2O

250 ms (fall time 200 ms)

250 ms

O2 500ms

HAL, ISO, SEV, DES 300 ms

< 4s

44

Chapter 4 Disassembling/Assembling &

Troubleshooting

4.1.1 Exploded View of DPM5

Figure 4-1 Exploded view of DPM5

NO

1

Material code

9201-30-35947

Part & Specification

Front cover assembly

2

3

9210-30-30181

M04-000305---

4 M02-000802---

Back plate assembly

Cross-head self-tapping screw 3*12

Quantity

1

1

5

4

5 9201-30-35944

6 9201-20-35971-

Support assembly (Lithium battery)

7 M04-003105---

8 9201-30-35948

Cross-head self-tapping screw M3*8

1

1

3

1

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

10

115-031469-00 TR6F 1

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

12 M04-004014---

13 M04-004017---

14 M04-051140---

Gasketed cross-head screw M4*10

Gasketed cross-head screw M3*12

4

2

2

45

4.1.2 DPM5 Display (TFT Display) Assembly

4

5

6

7

8

1

2

3

Figure 4-2 DPM5 display (TFT display) assembly

M04-004015--- Cross-head screw M3

×8

4

0010-10-12271 LG display LB121S02 1

9210-20-30180 12.1`back 1

9210-30-30169 LVDS-TTL adapter board 1

M04-002505--- Cross-head 2

9000E-10-04913 INVERTOR-TDK 2

M04-002405--- Cross-head 4

46

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

Figure 4-3 DPM5 support assembly

NO

1

2

3

Material Code

M04-004012---

9200-20-10689

M04-005005---

Part & Specification

Gasketed cross-head screw M3*6

Recorder regulating panel

Cross-head sunk screw M3*6

4 9201-20-35965

5 M04-002505---

6

7

9210-30-30150

9201-30-35922

Support

Cross-head screw M3*6

9210 main control board

Battery compartment assembly (Lithium battery)

8 M05-010001-06

9 9200-20-10516

10 051-000007-00

11 M04-060009---

12 9200-20-10677

Insulating plate of ECG board

Insulating plate of mounting plate 3

SPO

2

/IBP mounting plate

Insulating plate of mounting plate 4

13 9200-20-10676

14 9200-20-10678

15 M03A-30-26050

16 630D-30-09121

17 0010-10-12275

18

19

9201-20-36012

9201-30-35901

630D blood pressure pump

Power PCB insulating plate

Lithium battery power PCB

47

Quantity

24

1

14

1

10

1

1

2

1

1

1

1

1

1

1

1

1

1

1

20 9210-30-30163

21 9201-30-35908 Microstream

22 9201-30-35955

23 9201-20-35928 Mounting plate of microstream CO module

2

4.1.4 Front Cover Assembly

1

1

1

1

Figure 4-4 Front cover assembly

7

8

9

10

11

12

13

3

4

5

6

1

NO Material Code

2

M04-003105---

9200-30-10701

9200-20-35968

9200-20-10512

Part & Specification

Cross-head self-tapping screw 3*8

Alarm indicator panel (red-yellow indicator)

Alarm indicator cover

Foot plate 2

9200-20-10472 Button

9201-20-36031 Connector

48

14

15

M04-051004---

9201-30-35912

4.1.5 Back Cover Assembly

Cross-head self-tapping screw 2.6*6

9201 button panel

Figure 4-5 Back cover assembly (microstream CO

2

) (9201-30-35992)

2

3

4

NO Material Code

1 M04-003105---

9200-20-10620

Part & Specification

Cross-head self-tapping screw 3*8

Speaker press plate

9200-21-10633 Speaker

9200-20-10622 Hook mounting plate

5

6

7

8

9201-20-35970 Handle

9201-20-35969 Gland

9 M04-000305---

10

9201-30-35923

(microstream

Cross-head self-tapping screw 3*12

Mounting assembly of microstream CO connector

2

Remark

11

6200-20-11614 CO

2

nozzle

12 9200-20-10511 Foot plate 1

13 M04-000501--- Stainless steel nut GB6170MS

14

9201-30-35978 Fan

49

4.1.6 Microstream CO

2

Assembly

NO

1

2

3

4

5

6

Figure 4-6 Microstream CO

2

assembly

Material Code Part & Specification

M04-003105---

9201-20-36010

9201-20-35961

9201-20-35915

9201-20-35914

Cross-head self-tapping screw 3*8

Baffle of torsional spring

Retaining torsional spring of microstream CO

2 connector

Mounting plate of CO

2

connector

Baffle of CO

2

connector

50

4.2 Troubleshooting

4.2.1 Black Screen, Startup Failure

Y

Figure 4-7

Location flow of faults causing black screen

51

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.

52

Chapter 5 Test and Material List

Chapter 5 Test and Material List

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

53

Chapter 5 Test and Material List the TEMP parameter should be 35±0.1 , 37± ℃ ℃

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

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 SpO

2

Select PLETH as the HR source of DPM5, and put the finger into the SpO

2

sensor. The screen should display the PR and SpO

2

values normally. The normal SpO

2

value is above 97%.

5.1.7 IBP

1. Test fixture

Physiological signal simulator

2. Test procedure

① IBP1 test:

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

54

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.

②

IBP2 test:

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

5.1.8 CO

1. Test fixture

Physiological signal simulator

2. Test procedure

Injectate and blood temperature test: Assemble the TB and TI test fixture, output

36.0±0.1 , 37.0±0.1 and 38.

℃

2.0±0.1 .

CO measurement: Set the CO.CONST and T

I set the injectate switch to OFF, and then press START. Then the simulator will and 5±0.5L/M.

5.1.9 CO

2

1. Test fixture

CO

2

steel bottle (containing 10% CO

2

)

2. Test procedure

①

Sidestream CO

2

measurement: Set the calculation compensation of DPM5 to

COMMON.

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

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

2

steel bottle based on the interval of

3s. The CO

2

value should be the calibration gas pressure value: 76±5%mmHg. When the valve is opened permanently, the patient monitor prompts “APNEA ALARM”.

Unplug the water trap. The patient monitor prompts “CO

2

water trap OFF”. Plug the water trap again. The prompting message disappears.

②

When the measured value exceeds the high limit of CO

2

, the patient monitor prompts “CO

2

too high” on the main screen. When the measured

value is lower than the low limit, the patient monitor prompts “CO

2

too low”.

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 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.

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.

Tools required:

Gas bottle, with a certain standard gas or mixture gas. Gas concentration should meet the following requirements: AA>1.5%, CO

2

>1.5%, N

2

O>40%, O

2

>40%, of which AA 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

1

Material Code`

M04-004012---

2

3

9200-20-10689

M04-005005---

4 9201-20-35965

Name & Specification

Gasketed cross-head screw M3*6

Recorder regulating panel

Cross-head sunk screw M3*6

Support

5

6

7

M04-002505---

9210-30-30150

9201-30-35922 Battery compartment assembly (Lithium battery)

8 M05-010001-06

Cross-head screw M3*6

9210 main control board

Insulating plate of ECG board 9 9200-20-10516

10 812A-30-08557

11 M04-060009---

12 9200-20-10677

13 9200-20-10676

14 9200-20-10678

15 M03A-30-26050

Insulating plate of mounting plate 3

SPO

2

/IBP mounting plate

Insulating plate of mounting plate 4

16 630D-30-09121

17 0010-10-12275

28 9201-20-36012

630D blood pressure pump

SpO

2

module

Power PCB insulating plate

29 9201-30-35901

20 9210-30-30163

23 9201-20-35928

Lithium battery power PCB

21 9201-30-35908 Microstream

22 9201-30-35955

Mounting plate of microstream CO module

2

Quantity

24

1

14

1

10

1

1

1

1

1

2

1

1

1

1

1

1

1

1

1

1

1

1

63

FOR YOUR NOTES

Chapter 5 Test and Material List

64

Chapter 6 Maintenance and Cleaning

Chapter 6 Maintenance and Cleaning

6.1 Maintenance

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 monitor and disconnect 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

2

sensor, blood pressure cuffs and temperature sensor, refer to relevant chapters in Operation Manual.

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

66

Mindray DS USA, Inc.

800 MacArthur Blvd.

Mahwah, New Jersey 07430

USA

Tel:1.800.288.2121

Tel:1.201.995.8000 www.mindray.com

P/N: 046-000183-00(

5.0)