VS-800 Service Manual V2.1

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 (hereinafter called Mindray) owns all rights to this unpublished work and intends to maintain this work as confidential. Mindray may also seek to maintain this work as an unpublished copyright.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

+86 755 26582479

+86 755 26582888

Fax:

+86 755 26582934

+86 755 26582500

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

Monitor Description

Chapter 1 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 ºC～＋40 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

Key&display board

Battery chamber

Parameter board

Parameter software Upgrade software

Recorder board TEMP module chamber

Connection cables

Printer software

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 ower supply

Communication/p ower supply

LED & KEY

Key&display board

Ethernet RS232

Main board

LCD

NurseCall

Power supply

Speaker

Battery

Recorder

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 2.2.1.1

Principle diagram Watchdog

Ethernet

RTC SPI Serial port 0

CPU

Nurse Call Speaker

E 2PROM

PHY RTL8201

RS232 RS232 IC

Audio process circuit

SDRAM

Serial port 1: NIBP

Flash

Serial port 2: SpO2 FPGA

Serial port 3: Temp

1.5V Serial port 4: Recorder

Linear power 3.3V

12V

5.0V

LCD

LED

KEY

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

2.2.1.3.6 NURSE CALL connector 2.2.1.3.7

The 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 input

EMI filter

OVP&OCP

Rectifer & filter Rectifer & filter

16.8 V

LDO circuit Start-up circuit

Charging circuit PWM controller

Current detection

12V output

DC/DC converter

DC/DC converter

5V output

Battery

3.3V output OVP&OCP

Coupler feeckback & isolation circuit

Switch circuit OVP&OPP

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

LED

STN LCD module

LED&KEY

CPLD

Start-up

3.3V disable

circuit

Start-up signal

ADV Key matrix

3.3V

Switch

VSB

OFF/STANDBY 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