Mindray VS-800 Service Manual

VS-800

Vital signs monitor

Service Manual

Copyright

Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns all rights to this unpublished work and intends to maintain this work as confidential. Mindray may also seek to maintain this work as an unpublished copyright.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 equipment. No part of this can be disseminated for other purposes.

In the event of inadvertent or deliberate publication, Mindray 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 to do so.

All information contained in this publication is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, 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 patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties.

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

Content of this manual is maybe in defect of instructions ,If user has any problem ,Please consult my company customerservice .

PROPERTY OF SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. ALL RIGHTS RESERVED

Responsibility on the manufacturer party

Mindray is responsible for safety, reliability and performance of this equipment only in the condition that:

•all installation, expansion, change, modification and repair of this equipment are conducted by Mindray qualified personnel;

•applied electrical appliance is in compliance with relevant National Standards;

•the monitor is operated under strict observance of this manual.

I

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.

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.

This vital signs monitor is intended for use only by medical professionals in health care institutions.

To avoid electrical shock, you shall not open any cover by yourself. Service must be carried out by qualified personnel.

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.

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.

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.

II

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 VS-800 vital signs Monitor if:

■Assembly operations, extensions, re-adjusts, modifications or repairs are carried out by persons other than those authorized by Mindray.

■The VS-800 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).

III

Return Policy

Return Procedure

In the event that it becomes necessary to return a unit to Mindray, the following procedure should be followed:

1.Obtain return authorization. Contact the Mindray Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Return shipments will not be accepted if the Mindray 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 for service (this includes customs charges).

Company Contact

Address:	Mindray Building, 12th Keji Road South, Hi-tech
	Industrial Park, Nanshan, Shenzhen, P.R.China
Phone:	[phone]	[phone]
Fax:	[phone]	[phone]

IV

Safety Precautions

1 . Meaning of Signal Words

In this manual, the signal words DANGER, WARNING, and CAUTION are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual.

Signal word	Meaning
DANGER	Indicates an imminently hazardous situation which, if not
	avoided, will result in death or serious injury.
WARNING	Indicates a potentially hazardous situation which, if not avoided,
	could result in death or serious injury.
CAUTION	Indicates a potentially hazardous situation which, if not avoided,
	may result in minor or moderate injury.
CAUTION	Indicates a potentially hazardous situation which, if not avoided,
	may result in property damage.

2 . Meaning of Safety Symbols

Symbol

Description

Type-BF applied part

"Attention" (Refer to the operation manual.)

3 . Safety Precautions

Please observe the following precautions to ensure the safety of service engineers as well as operators when using this system.

DANGER: Do not use flammable gasses such as anesthetics, or flammable

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

V

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 overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped.

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.

VI

	Content
	Content
Chapter 1 Monitor Description..........................................................................................		1-1
1.1	Intended Use..............................................................................................................	1-1
1.2	Environmental Specifications .....................................................................................	1-1
Chapter 2 Principles of Operation ....................................................................................		2-1
2.1	General ......................................................................................................................	2-1
2.2	Hardware Description.................................................................................................	2-2
2.3	Software Description ................................................................................................	2-13
2.4	System parameters ..................................................................................................	2-17
Chapter 3 Chapter Specifications.....................................................................................		3-1
3.1	Type of Monitor ..........................................................................................................	3-1
3.2	Specifications of Monitor ............................................................................................	3-1
Chapter 4 Machine Disassembly/assembly and troubleshooting .....................................		4-1
4.1	Disassembly/assembly Figure....................................................................................	4-1
4.2	Inter-board Connections...........................................................................................	4-12
4.2	Troubleshooting........................................................................................................	4-16
Chapter 5 Machine Test and Material List ........................................................................		5-1
5.1Test Procedure ............................................................................................................		5-1
5.2	Material List................................................................................................................	5-3
5.3	NIBP Calibration Method............................................................................................	5-7
Chapter 6 Maintenance and Cleaning ............................................................................		6-1
6.1	Inspection...................................................................................................................	6-1
6.2	General Cleaning .....................................................................................................	6-2
6.3	Cleaning Solution .......................................................................................................	6-2
6.4	Disinfection.................................................................................................................	6-3
6.5	Contact Information for Maintenance and Technical Support .....................................	6-3

I

Content

For your notes

II

Monitor Description

Chapter 1 Monitor Description

1.1 Intended Use

This Monitor is intended for monitoring the patient’s vital signs including Non-invasive Blood Pressure (NIBP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR) and Temperature (TEMP) for single adult, pediatric and neonatal patient.

This Monitor is intended for use in the health-care institutions such as Outpatient Clinics, Emergency Departments, Medical Floors, Clinics and Nursing Departments. It, however, is not intended for critical patient monitoring, hospital transport or home use.

This Monitor is to be operated by clinical physicians or appropriate medical staffs under the direction of physicians. The operator of the monitor must be well tranined. Any operation by unauthorized or non-tranined personnel is forbidden.

1.2 Environmental Specifications

1.2.1 Temperature Requirements

Operating ambient temperature	0 ºC - 40 ºC
	10 ºC40 ºC 50ºF -104ºF (SmarTemp™ TEMP
	module)
Storage temperature	-20 ºC – 60 ºC

1.2.2 Relative Humidity

Operating relative humidity	15%-95%(non-condensing)
Storage relative humidity	10%-95%(non-condensing)

1.2.3 Altitude Requirements

atmospheric pressure at working conditon	70 to 106KPa
(operating altitude)	-500 to 4600m, -1640 to 15092ft
atmospheric pressure in Storage	22 to 107.4KPa
(Storage altitude)	-500 to 13100m, -1640 to 42979ft

1-1

Monitor Description

1.2.4	Power Requirements
Voltage:	AC 100-240 V, 50/60 Hz
Power:	70VA

1.2.5 Rechargeable Battery

Rechargeable lead-acid battery, 2.3 Ah, 12V

Minimum of 260min:

The monitor runs on power supplied by the new fully-charged battery in the following

conditions:

Ambient temperature: 25ºC

Monitor configuration: SpO2 (Continuous measurement) and NIBP (one auto NIBP measurement per 15min)

Charge time: Maximum of 8h

Lithium battery, 4.4Ah, 11.1V

Minimum of 620min

The monitor runs on power supplied by the new fully-charged battery in the following conditions:

Ambient temperature: 25ºC

Monitor configuration: SpO2 (Continuous measurement) and NIBP (one auto NIBP measurement per 15min)

Charge time: Maximum of 8h

Time to shutdown at low battery power: 5 to 15min after the first battery-low alarm (a

new fully-charged battery should be used)

1-2

Principles of Operation

Chapter2 Principles of Operation

2.1 General

The whole system consists of mechanical, hardware and software parts, as follows:

System

Mechanical

Hardware

Software

Power board

Host

System

software

Main board

Recorder

Parameter

Key&display

software

board

Parameter

Battery

Upgrade

chamber

board

software

Recorder board

TEMP module

Printer

chamber

Connection

software

cables

Figure 1 System structure

As shown in Figure 2-1, the VS-800 Vital Signs Monitor consists of

•4 mechanical parts: host, recorder, TEMP module chamber and rechargeable battery chamber;

•6 hardware parts: main board, key&displays board, parameter boards, recorder board, connection cables and power board;

•4 software parts: System software, Parameter software, Upgrade software and printer software.

2-1

Principles of Operation

2.2 Hardware Description

The hardware structure of the VS-800 is shown as Figure 2-2:

			SpO2 module		TEMP module
		NIBP module
			Isolation power
			board *
			Communication/p		Communication/p
			ower supply		ower supply
		LED &				Ethernet
		KEY
	Key&display	LCD	Main board			RS232
	board
		Power				NurseCall
		supply
		Speaker	Recorder			Battery
				Fan	Power board	AC
			VS-800

* Mindray SpO2 module does not require the isolation power board.

Figure 2 Structure of hardware

Note1: The TEMP module mentioned in this manual is reserved for future use.

The hardware connections of the VS-800 Vital Sings Monitor are as shown in Figure 2-3:

2-2

Principles of Operation

Figure 3 Connections of VS-800 hardware

As shown in the figure above, the core of the system is the main board, from which the power is adapted to all parameter modules; the parameter modules directly communicate with the main board, and the measurement and status of all modules are controlled by the main board. The functions and operation principles of the VS-800 hardware parts are detailed respectively in the following sections.

2-3

Principles of Operation

2.2.1 Main Board

2.2.1.1Principle diagram

		Watchdog
Ethernet	PHY			RTC	E 2PROM
				SPI
	RTL8201
		CPU	Serial port 0		RS232
Nurse Call
				RS232 IC
	Audio process
Speaker	circuit				Serial port 1: NIBP
	SDRAM	Flash			Serial port 2: SpO2
				FPGA	Serial port 3: Temp
	1.5V
					Serial port 4: Recorder
	Linear power
	3.3V	5.0V	12V	LED	KEY
			LCD

Figure 4 Operation principle of the main board

2.2.1.2 Principle

The main board communicates with all parameter modules and recorder module through serial ports; the power of the parameter modules is adapted from the main board.

The main board supplies displaying information for the key&displays board detects the keys and realizes the user’s interface.

The audio process circuit of the main board drives the speaker, thus to realize audible alarms, key tones and PITCHTON.

The main board controls the alarm indicator through the signal wire is adapted from the key&displays board.

In addition, the main board provides the nurse call connector, network connector and R232 connector.

The real-time clock is realized by the RTC chip to which the power is supplied from AC mains or by the battery when available. When the AC power or battery is unavailable, the built-in battery of the RTC chip supplies the power, thus guaranteeing the normal working status of the clock.

SDRAM is responsible for storing data temporarily and running programs; FLASH serves as the system program memory and trend data memory; E2PROM serves as the device configuration memory.

2-4

Principles of Operation

2.2.1.3 Units of main board

2.2.1.3.1 FPGA

FPGA is used for:

Controlling STN-LCD

The PFGA drives the display of the monochromatic STN-LCD module, including the RAM and displaying sequence; it communicates with the key&displays board CPLD.

The FPGA transmits data displayed by LEDs and receives key information by Means of communicating with keypad CPLD through synchronous serial port.

Extending serial ports

The FPGA extends 3 serial ports for the communications with parameter modules. Extending I/O port

The FPGA extends the I/O port for controlling the NURSE CALL circuit. Generating frequency-adjustable signal

The FPGA generates the frequency-adjustable signal which is used by the audio process circuit.

2.2.1.3.2 Audio process circuit

Following the common scheme regarding the key&displays board audio process circuit, the audio process circuit generates envelope signals by using the PWM function of the CPU, and generates audio frequency signals by using the FPGA.

2.2.1.3.3 ADC circuit

The ADC circuit detects ADV, +12V and battery voltages as well as the battery status voltage by using the A/D converter. The A/D converter Provides a I2C bus interface. The CPU simulates the I2C bus signal with two I/O ports.

2.2.1.3.4 Network connector

To guarantee that the earth wire of the network connector can pass the 1500V high-voltage test, isolated components such as the network transformer must be placed near the RJ45 socket and kept a specific distance from other components.

2.2.1.3.5 RS232 connector

The RS232 connector is made of the UART module of the CPU and the RS232 chip. The RS232 chip has the ESD protection function (±15KV).

2-5

Principles of Operation

2.2.1.3.6NURSE CALL connector

2.2.1.3.7The NURSE CALL connector controls the NURSE CALL signal by using an I/O port extended by the FPGA.

2.2.2 Power Board

2.2.2.1 General

The power board converts the power input (from AC mains or battery) to different working voltages for other boards; it also has the function of charging the battery.

2.2.2.2 Principle diagram

According to the design requirements, the power board can be divided into three parts: AC/DC

isolation converter, DC/DC converter and charging circuit, as shown in Figure 2-5.

				Flyback converter
	AC		EMI filter	Rectifer & filter
	input
				Rectifer
				& filter
		Start-up
			circuit
			PWM	Current
			controller	detection
				Coupler feeckback
				& isolation circuit
				OVP&OPP

		OVP&OCP
16.8		12V
V	DC/DC
	converter	output
	LDO	5V output
	circuit
	Charging	Battery
	circuit
	DC/DC	3.3V output
	converter
		OVP&OCP
	Switch circuit

Figure 5 Operation principle of the power board

2.2.2.3 Principle

After the AC input reaches the power board through the connection board, it flows through the EMI filter circuit and rectifier and filter circuit. Then it is converted to a DC voltage, which is further converted to the 16.8V DC voltage by the Flyback converter. The 16.8V DC voltage is the main input of the DC/DC converter and charging circuit; it is used to charge the lithium battery or lead-acid battery, and also converted to 12V, 5V and 3.3V DC voltages by corresponding DC/DC converters and LDO circuit. In case the AC input is unavailable, the battery can supplies power for the DC/DC converters to get the 12V, 5V and 3.3V DC voltages. Meanwhile, the 12V, 5V and 3.3V DC outputs are under the control of the switch signal.

2-6

Principles of Operation

The 16.8V DC output is protected against over-voltage and over-power; the 12V and 3.3V DC

outputs are protected against over-voltage, short-circuit and over-current; the 5V DC output is

protected against over-voltage and short-circuit.

2.2.3 Key&displays board

2.2.3.1 General

The key&displays board provides the user’s interface. The main board supplies the power for

the key&displays board. The LCD module, 7-segment digit display, LED indicators and keys

are integrated on this board.

Principle diagram
	STN LCD	LED
	module
		CPLD		LED&KEY
	3.3V		Start-up
		disable	circuit	Start-up signal
ADV
3.3V	Key
	matrix	Switch		OFF/STANDBY
VSB				detection

Figure 6 Operation principle of the key&displays board

2.2.3.2 Units

2.2.3.2.1 LCD module

This module has the function of adjusting the contrast and brightness in 10 levels, Self-provided drive.

The FPGA controls the LCD. It transmits data signals and control signals to the LCD drive to realize the display on the LCD.

The main board supplies the 3.3V power for the logic part of the LCD module, and the power board supplies the 3.3V power for the backlight assembly.

This module displays menus, trend data and plethysmograms.

2-7

Principles of Operation

2.2.3.2.2 LED

There are Six groups of 7-segment digit display on the key&displays board. They are used for displaying the systolic pressure, diastolic pressure, mean pressure/cuff pressure, SpO2, PR and Temp; every group is of 3 digits.

The signal is transmitted from the main board FPGA to the CPLD, and is displayed by the 7-segment digit displays driven by the CPLD scanning.

The AC indicator is driven by the ADV voltage output from the power board.

The working status indicator (ON/STADNDBY indicator) is driven by the 3.3V voltage. The battery indicator is controlled by the flash control signal, ADV signal and /BC signal

together. When the system is powered by the battery only, the CPLD outputs the flash control signal and the battery indicator flashes; when the system is power by AC mains, the ADV voltage drives the battery indicator to ON. The /BC signal is transmitted from the power board to the cathode of the battery indicator. When there is no battery in the monitor, the resistance of the /BC becomes high, so the battery indicator will never become ON.

The bichrome LED alarm indicator is driven by the 3.3V voltage and controlled by the flash control signal output from the CPLD.

For other LED indicators, the anodes are connected to 3.3V voltages and are controlled by the CPLD I/O port.

The displaying and controling is signal of the indicators above is delivered from the main board FPGA to the CPLD.

2.2.3.2.3 Keys

There are totally 12 keys.

ON/STANDBY key: In the OFF status, press this key to power on the monitor; in the working status, press this key for less than 1s to enter the standby status. Press this key for more than 2s to power off the monitor.

The other 11 keys form a 3×4 matrix. The CPLD scans the key matrix, and performs the key debouncing after detecting any key input signal. If the input signal is valid, the CPLD saves the current key input code and transmits it to the main board.

2-8

Principles of Operation

2.2.4 SpO2 Module

2.2.4.1 General

The SpO2 module provides the function of measuring the Pulse Oxygen Saturation (SpO2).

2.2.4.2 Principle diagram

Figure 7 Operation principle of the SpO2 module

2.2.4.3 Principle

The SpO2 measurement principle:

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

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

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

2.2.4.3.1 Led Drive Circuit

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

2.2.4.3.2 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.

2-9

Principles of Operation

2.2.4.3.3 A/D

The A/D conversion part converts the analog signal to the digital signal, and then sends it to CPU for further processing.

2.2.4.3.4 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.

2.2.4.3.5 CPU System

Implementing the logical control of all the circuits;

Implementing the data processing for the SpO2 parameter;

Implementing the communication with the main board.

2.2.4.3.6 Power & Signal isolate Circuit

Isolating the external circuits to ensure the safety of human body;

Supplying power for all circuits;

Implementing the isolation communication between the CPU System and the main board.

2.2.5 NIBP Module

2.2.5.1 General

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

2.2.5.2 Principle diagram

Figure 8 Operation principle of the NIBP module Principle

2-10

Principles of Operation

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.

2.2.5.2.1 Valve Drive Circuit

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

2.2.5.2.2 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.

2.2.5.2.3 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.

2.2.5.2.4 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.

2.2.5.2.5 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.

2.2.5.2.6 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.

2-11