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owns all rights to this unpublished work and intends to maintain this work as confidential.
Mindray may also seek to maintain this work as an unpublished copyright.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).
In this manual, the signal wordsDANGER, WARNING, andCAUTION 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
WARNING
CAUTION
CAUTION Indicates a potentially hazardous situation which, if not avoided,
Indicates an imminently hazardous situation which, if not
avoided, will result in death or serious injury .
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.
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
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.
• 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
NIBP module
Communication/p
LED &
KEY
Isolation power
board *
ower supply
Key&display
board
LCD
Power
supply
Speaker
Recorder
Main board
Fan
VS-800
* Mindray SpO2 module does not require the isolation power board.
TEMP module
Communication/p
Power board
ower supply
Ethernet
RS232
NurseCall
Battery
AC
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
2.2.1 Main Board
2.2.1.1 Principle diagram
Ethernet
PHY
RTL8201
Principles of Operation
Watchdog
RTCE2PROM
SPI
Nurse Call
Speaker
Audio process
circuit
1.5V
Linear power
3.3V
FlashSDRAM
5.0V
CPU
12V
Serial port 0
LCD
RS232 IC
FPGA
LED
KEY
RS232
Serial port 1: NIBP
Serial port 2: SpO2
Serial port 3: Temp
Serial port 4: Recorder
Figure 4 Operation principle of the main board
2.2.1.2 Principle
The main board communicates with all parameter modules and re corder module throug h 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
2
the system program memory and trend data memory; E
PROM 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 I
simulates the I
2
C bus signal with two I/O ports.
2
C bus interface. The CPU
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.
AC
input
EMI filterRectifer & filter
Start-up
circuit
PWM
controller
Current
detection
Flyback converter
Coupler feeckback
& isolation circuit
Rectifer
& filter
OVP&OPP
16.8
V
DC/DC
converter
LDO
circuit
Charging
circuit
DC/DC
converter
Switch circuit
OVP&OCP
12V
output
5V output
Battery
3.3V output
OVP&OCP
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
module
LED
LED&KEY
CPLD
Start-up
circuit
Start-up signal
OFF/STANDBY
detection
ADV
3.3V
VSB
Key
matrix
3.3V
disable
Switch
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, SpO
, PR
2
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 co nnected t o 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 SpO
Implementing the communication with the main board.
parameter;
2
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
Principles of Operation
2.2.6 TEMP Module
General
This module provide the function of measuring the temperature.
Schematic diagram
图 2-1TEMP schematic diagram
Principle
Normally, the sensor used for measuring temperature is a thermistor. The resistance of a given
thermistor is nonlinearly relative to the temperature. Thus, the resistance of a thermistor can be
conversed into temperature. By applying given field current to the thermistor, its resistance can be
easily obtained by measuring the voltage on the thermistor.
Temperature Detection Circuit
The resistance of the thermistor ch anges as the temperature change. Temperature detection circuit
converts the change of resistance into voltage difference and amplifies the signals to certain range
and then sends the signals to the sampling circuit.
Probe Recognition Circuit
Probe recognition circuit recognize the oral/axillary and rectal temperature probe of the TEMP
module.
2-12
Principles of Operation
Probe Heating Circuit
Probe heating circuit warms up the probe to a constant temperature and keep it so as to shorten the
measuring time.
A/D
The A/D conversion part converts the analog signal to the digital signal, and then sends it to
CPU for further processing.
CPU System
CPU system implements the logical control of all the circuits, the data processing for the TEMP
parameter and the communication with the main control board.
Power & Signal Isolation Circuit
Power & signal isolation circuit implements the conversion of the power supply and the isolation
of the signals.
2.3 Software Description
2.3.1 General
2.3.1.1 Composition of software
The VS-800 software consists of the system software, module software, upgrade software and
printer software.
Besides the system software, all the other software components are universal. Therefore, the
following sections will emphasize on the requirements of the system software. For other
software, only references are provided.
表 2-1 VS-800 software components
Software component Description Material code of
universal
component
System software For different configurations (SpO2 only and
full configuration), the LED requires two
different kinds of software.
S1C33209 write software of the SpO
board
MASIMO M7 SpO
software
2
2
630D-30-09112
9006-30-33911
(See Note 1)
Nellcor SpO2 NELLCOR MP506 SpO2 software
TEMP
Predictive TEMP module software
G-M09A-30-62120
Recorder 33209 write software of the MCU TR6C-30-16656
Note 1: Those software components are external, namely, they are not developed by
Mindray.
2.3.2 System Software
2.3.2.1 General
The functions of the system software are shown in Figure 2-9:
System software
Parameter
module
Patient
Keypad
Nurse
Figure 9 Function of system software
The VS-800 software provides the following functions:
1 Transmitting/receiving data to/from modules;
2 Displaying parameters, plethysmograms and trend data;
3 Rising alarms;
4 Controlling the recorder;
5 Reviewing patient history data;
PC
LCD
LED
Thermal recorder
6 Network function;
7 NURSECALL function;
8 Power management;
2-14
Principles of Operation
9 Displaying measurement results with LEDs;
10 Outputting data to PC for permanent storage and data printing.
2.3.2.2 Functions of system software
2.3.2.2.1 Power management
A. The system detects the battery and battery volume automatically, and power LED
gives status of battery.
B. The system detects the voltage (12V) of the main board periodically. Once the
voltage exceeds 12V limit, stop the ongoing NIBP measurement.
2.3.2.2.2 Parameter measurement
The parameter measurements are performed respectively by parameter modules. The system
software is responsible for processing data and displaying the results.
2.3.2.2.3 Data output
Trend data can be recorded. The recorded data can be queried on the LCD, output by the
recorder or through the network. In addition, the monitor can be connected to the central
monitoring system, thus performing data output.
2.3.2.2.4 Alarm paused/silenced
The audible alarms are compliant with IEC60601-1-8.
The alarm pause period is 2 minutes; the system can also be silenced.
2.3.2.2.5 Network
Central Monitoring System (CMS)
Data output
Software upgrade
2.3.2.2.6 Pitch Tone
With the Pitch Tone function, the system can dynamically change the pulse tone.
Nurse Call
The Nurse Call function is used for outputting alarms.
2.3.2.2.7 Standby
When the monitor receives no physiological signals or gives a battery-low alarm,
In the monitoring status, press the ON/STANDBY key for less than 2s. The CONFIRM
STANDBY STATE dialog box appears, prompting “Enter the Standby State. Yes?” Select YES
2-15
Principles of Operation
to enter the standby status.
In the standby status, press any key on the front panel of the monitor or withdraw the
temperature probe from the probe sheath to exit the standby status. The EXIT STANDBY
dialog box appears, prompting “Enter monitoring state?” Select YES to exit the Standby status
and enter the monitoring status. If no operation is done within 30 seconds, the monitor will
automatically select NO, this dialog box will disappear, and the monitor will keep in the Standby
status.
The monitor exits the standby status and enters the monitoring status automatically when
The monitor receives SpO
physiological signal for 5 seconds or more;
2
The monitor is powered by the internal battery which is to be depleted.
2.3.2.2.8 Mode modification
A. Format of date: Chinese (-year-month-day); European: (day-month-year); American
(month -day- year). The review date of the trend data corresponds to the system time.
B. Precision of real-time clock: ±1 minute/month at 213±. ℃
Display resolution: 1s
Range: 2001 0: 0: 0 -2099 23: 59: 59
2.3.2.2.9 Alarm message
A. Alarms include physiological alarms and technical alarms,Alarms classed 3 gra de:high、
middle and low alarm.
a) Every parameter has an alarm switch. If the alarm function of a parameter is disabled, no
audible and visual alarm will be given in case exceptions occur.
b) The alarm function is compliant with relevant standards.
B. Alarm mode
a) The speaker and alarm indicator give the audible and visual alarms, the LED flashes, and
alarm messages are displayed on the LCD.
b) When alarms of the two alarm levels occur, the system gives the high-level alarm.
C. If the monitor is connected to the Nurse Call system properly, the alarm, if any, can be
given through the Nurse Call system. The reviewed trend data begin to be stored.
2.3.2.2.10 Non-volatile data storage
The monitor can store modified configurations. Besides the factory default configuration, the
2-16
Principles of Operation
monitor can store 1 group of user default configuration for each patient type.
Storage of trend data: In the full configuration, the non-volatile data include trend data of all
parameters: systolic pressure, mean pressure, diastolic pressure, PR, SpO
time and patient ID.
, measurement
2
2.3.3 Module Software
The module software implements the upper-level communication protocol through the
communication port.
2.3.4 Upgrade Software
The upgrade software implements, through the Ethernet and PC, the online upgrade of the
system software of the monitor and module software.
The upgrade software package includes the bootstrap and PC upgrade software. The
bootstrap, which takes the main board as the platform, provides the online upgrade functions
of system software and module software as well as the system function configuration. The PC
upgrade software, which takes the PC as the plat form, communicates with the monitor through
the Ethernet, and provides operators with the upgrade/configuration UI.
The FPGA upgrade software is controlled by the main board.
The upgrade software realizes the multi-language downloading and upgrade function.
2.3.5 Printer Software
The printer software, which takes the PC as the plat form, receives dat a output from the monitor,
and implements the data display, storage and printing.
2.4 System Parameters
2.4.1 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
2-17
Principles of Operation
the A/D converte r, and finally processed by the MCU. After that, the systolic pressure, diastolic
pressure and mean 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 auto measurement be done according to the preset procedure. 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.
2.4.2 SpO2
The SpO2 value is obtained through the pulse waves of the finger tips based on specific
algorithm and clinical data. The SpO
LEDs and an inbuilt light receiver. The two LEDs include one red-light diode and one infrared
diode, which emit light in turns. When the capillaries in the finger tip are iteratively congested
with blood pumped by the heart, the light emitted by the LEDs, after absorbed by the
capillaries and tissue, casts on the light receiver, which can sense, in the form of electric signal,
the light strength changing with the pulsated blood. The DC/AC ratio of the two photoelectric
signals corresponds to the content of the oxygen in the blood. Therefore, the correct pulse
oxygen saturation can be obtained with specific algorithm. Moreover, the pulse rate can be
obtained according to the pulse waveform.
The circuit of the SpO
module is involved in four parts: SpO2 probe, signal processing unit,
2
LED-driven sequencing control part and the MCU.
probe is the measurement transducer. It has two inbuilt
2
2-18
Principles of Operation
2.4.3 TEMP
Body temperature can be taken with two different methods according to the temperature probe
used. One method is direct measurement with which the temperature is measured by thermal
equilibrium. Therefore, thermistor, platinum resistance or mercury can be used in the temperature
probe. Direct temperature measurement is the standard method for measuring body temperature
and it is commonly used for clinical diagnosis. With this method, we can obtain accurate
temperature reading, however, it takes longer time since we need time for reaching thermal
equilibrium. Another temperature measuring method is indirect, which uses thermal radiation of
human body to obtain body temperature. Thus, the probe can be an infrared sensor. Indirect
temperature measurement takes shorter time but the measurement error is greater
Direct temperature measurement can be classified as continuous monitoring and predictive
measurement. Continuous monitoring thermometer continuously monitors body temperature and
displays the temperature reading in real time by applying the temperature probe to the measured
site. Since it takes time for heat conduction between the human body and the thermometer,
continuous monitoring takes relatively longer time to reach the final temperature, normally 3
minutes in oral mode and 5 minutes in axillary mode. In predictive thermometer, a heating device
is connected with the temperature detector. Time for reaching the thermal equilibrium between the
temperature probe and the measured site is shortened with the heating device before temperature
measurement. Additionally, the temperature at which thermal equilibrium is reached is predicted
according to the temperature curve of the probe in given time. Since the final temperature of the
measured site can be obtained without taking time for reaching the thermal equilibrium, measuring
time can be shortened effectively.
The predictive TEMP mode provide both continuous monitoring (in MONITOR mode) and
predictive measurement (in PREDICT mode).
2-19
Principles of Operation
For your notes
2-20
Product Specifications
Chanpter3 Product Specifications
3.1 Type of Monitor
Type of protection against electrical shock Class I, internally powered equipment
EMC Class A
Degree of protection against electrical shock NIBP/SpO
Defibrillation-proof
Monitor: B
Degree of protection against harmful
ingress of water
Degree of protection against hazards of
ignition of flammable anesthetic mixtures
Methods of sterilization Refer to the operation manual for
Figure 25 Isolation power board to the TEMP module connection cables
4.3 Troubleshooting
4.3.1 Cannot start
4-16
Machine Disassembly/Assembly and Troubleshooting
Cannot start
YN
Check the keypad-to-main board signal line for fault;
Check the keypad-to-power board signal line for fault;
Check t he keyboard for fa ult
Check the main board for fault;
Ch eck t he po wer bo ard for fault;
above un its one by one
Check if the AC indicator
is lit
Check/replace the
so as to locate the
faul t;
end
Check if the power
supply is normal
Y
Check the AC power
cord is n orma
Check the k eypad-to-power board sign al
li ne for fault;
Check the keyboard for fault
Ch eck t he mai n boa rd for fau lt;
Check the power board for fault;
l
Y
N
Y
Check if battery is
installed;
Y
Check if the battery
has electricity;
N
N
N
Figure 25 Black Screen Troubleshooting Map
4.3.2 LCD Black, Backlight Off
1. Check if the LCD signal line is in good condition;
2. Check if the keypad power cord is in good condition;
3. If the problem still remains after the connection cables are replaced, replace the
LCD module:
4. If the problem still exists, check the keypad, power board or main board.
4.3.3 LED Displays Abnormally
1. Check if the LED signal line is in good condition;
2. Check if the keypad power cord is in good condition;
3. Check if the button signal line is in good condition;
4. If the problem still exists, check the keypad, power board or main board.
4.3.4 Alarms Soundless
1. Check if the sound is turned off in the software setup;
4-17
Machine Disassembly/Assembly and Troubleshooting
2. Check the speaker connection cables;
3. Replace the speaker;
4. Replace the main board.
4.3.5 Cannot Print
1. Check if the software has recorder-related alarms. If yes, eliminate them;
2. Check if the recorder indicator is lit;
3. If not, check the recorder signal input connection cables;
4. Check the recorder power input connection cables (including the recorder power
board);
5. Replace the recorder module.
4.3.6 Paper Travels Abnormally
1. Check if the recorder paper roller has got something;
2. Check if the recorder print head has got something;
3. Check if the recorder power voltage >7.8V.
4.3.7 NIBP cannot Work Correctly
1. Check if the NIBP hose is not obstructed;
2. Check if the NIBP signal line is in good condition;
3. Otherwise, replace the NIBP module.
4.3.8 SPO2 Works Abnormally
1. Check if the accessories are correct;
2. Check if the SpO2 signal line is in good condition;
3. Check if the SpO2 communication cable is in good condition;
4. Otherwise, replace the SpO2 module.
4-18
Machine Disassembly/Assembly and Troubleshooting
4.3.9 TEMP Module Works Abnormally
1. Check that the temperature probe is correct;
2. Check that the communication cable is in good condition;
3. Check that the TEMP module self-check properly;
4. Otherwise, replace the TEMP module.
4-19
Machine Disassembly/Assembly and Troubleshooting
For your notes
4-20
Machine test and Material List
Chanpter5 Machine test and Material List
5.1 Test Procedure
Connect the simulators, power and fixture to the VS-800 and power it on. The LED and LCD
modules should display correctly
5.1.1 Button Function Test
Press each button on the keypad. The VS-800 should give corresponding response and
perform corresponding function. Refer to the VS-800’s Operation Manual.
5.1.2 NIBP Test
After connecting the NIBP simulator, adult cuff and accessories properly, connect the cuff to
the CUFF connector on the monitor and tighten it by turning clockwise.
1. After self-tests pass, press ENT to enter the ADULT mode. Set the simulator to the
blood pressure 255/195/215 mmHg, SHIFT +15 and HR 80BPM, and the VS-800 to the
ADULT mode. Press START for around 30 seconds, and the results will be calculated.
The test results are 270±8mmHg, 210±8mmHg and 230±8mmHg.
2. Press ECS and↓ on the simulator to enter the NEONATE mode. Set the simulator to the
blood pressure 120/80/90 mmHg and HR 120 BPM, and the VS-800 to the NEONATE
mode. Press START for around 30 seconds, and the results will be calculated. The test
results will be 120±8mmHg, 80±8mmHg and 90±8mmHg respectively.
3. Press ESC and ↓ on the simulator to enter the NEONATE mode. Set the simulator to the
blood pressure 60/30/40 mmHg, SHIFT—20 and HR 120 BPM, and the VS-800 to the
NEONATE mode. Change the simulator accessory to a neonatal cuff. Press START for
around 30 seconds, and the result displayed should be 40±8mmHg, 10±8mmHg and
20±8mmHg.
5.1.3 SpO2 Test
Insert a finger into the SpO2 sensor. The screen should display the values of PR and SpO2
correctly. The normal SpO2 should be above 97%.
5-1
Machine test and Material List
5.1.4 TEMP Test
The monitor shall correctly measure normal body temperature. When monitoring ambient
temperature in MONITOR mode, the temperature reading displayed shall be in normal range and
continuously shown on the temperature display area.
5.1.5 Recorder Print Test
1. Print SpO2 graph. The recorder should print correctly and the printed results should
be clear and consistent. If set such faults such out of paper, etc., corresponding
prompts should be given. After the fault is removed, the VS-800 should be able to
work correctly.
2. Print trend data. The recorder should print in accordance with what described in the
Operation Manual.
5.1.6 Clock Test
Verify the accuracy of clock counting when conducting the system test, and then set the clock to the
current time.
5.1.7 Whole Parameter Test
Plug all monitoring parameters and monitor them one by one. During the simultaneous monitoring of all
parameters, the parameters should not interfere with each other.
5.1.8 Set Defaults at the time of loading Software
Perform such main menu operations as patient information management, trend data review,
system setup, etc. The system responds correctly and no obvious error occurs during
functioning. Each function meets the product requirements.
5-2
Machine test and Material List
5.2 Material List
1 6006-20-39350 Handle cap
2 6006-20-39351 Rear housing
3 6006-30-39352 Main board
4 6006-20-39353A PCB board for main board
5 6006-30-39354 Keypad
6 6006-20-39355A PCB board for keypad
7 6006-20-39358 Front housing
8 6006-20-39359 Battery door
9 6006-20-39360 NIBP parameter connector cap
10 6006-20-39361 Alarm light cover
Temperature module cap (No
11 6006-20-39362
12 6006-20-39366 SpO2 mount bracket
13 6006-20-39367 Master bracket (lead-acid)
14 6006-20-39368 NIBP bracket
15 6006-20-39369 Recorder bracket
16 6006-20-39370 Serial port bracket
17 6006-20-39372 Silicon button
18 6006-20-39373 Fan bracket
19 6006-20-39374 Machine label (Chinese)
20 6006-20-39375 Foot cushion
21 6006-20-39376 Battery door connection bond
22 6006-20-39378 SPO2 parameter connector cap
23 6006-20-39379 Speaker press plate
24 6006-20-39380 Main board power cord
25 6006-20-39381 Recorder signal line
26 6006-20-39382 SpO2 module connection cables
27 6006-20-39383 Keypad signal line
28 6006-20-39384 LCD signal line
29 6006-21-39385 Speaker and connection cables
30 6006-21-39386 Power board AC input connection cables
Calibration method: Increase the pressure at intervals of 50mmHg(6.7kPa). The maximum
difference between the monitor and calibrator at any pressure point within the measurement
range does not exceed ±3mmHg (±0.4kPa). Similarly, when decreasing the pressure, the
difference between the monitor and calibrator at any pressure point within the measurement
range should not exceed±3mmHg (±0.4kPa).
5-7
Machine test and Material List
For your notes
5-8
Maintenance and Cleaning
Chanpter6 Maintenance and Cleaning
6.1 Inspection
6.1.1 Inspection before Using the Monitor
Before using the monitor, check:
1. The monitor for mechanical damages;
2. All exposed wires, male connectors and accessories;
3. All functions that may be used on patients, thus guaranteeing the good performance
of the monitor.
In case of any indication of functional damage, stop using the monitor, and contact bio-medical
engineers of the hospital or Mindray service engineers immediately.
6.1.2 Routine Inspection
An overall inspection, including the functional safety inspection, must be performed on the
monitor by qualified personnel for every 6-12 months or after maintenance each time. All
inspections must be performed by qualified service personnel when it is necessary to
disassemble the monitor.
Warning
Failure on the part of the responsible hospital or institution employing the
monitoring equipment to implement a satisfactory maintenance schedule may
cause undue equipment failure and possible health hazard.
6-1
Maintenance and Cleaning
6.2 General Cleaning
Warning
Be sure to shut down the system and disconnect all power cords from the
outlet before cleaning the equipment or accessories.
The VS-800 Vital Signs Monitor should be free from dust.
The exterior surface and LCD should be cleaned with non-corrosive cleaning solutions, such
as the diluted soap water and water.
• Warning
To avoid damages to the VS-800 Vital Signs Monitor:
ALWAYS dilute the solutions according to the manufacturer’s suggestions;
ALWAYS wipe of f all the excess cleaning solution with a dry cloth after cleaning;
NEVER submerge the equipment into water or any cleaning solution, or pour or
spray water or any cleaning solution on the equipment;
NEVER permit fluids run into the casing, switches, connectors, or any ventilation
openings in the equipment;
NEVER use abrasive or erosive cleaners of any kind as well as cleaners containing
acetone.
6.3 Disinfection
Disinfection may cause damage to the equipment; therefore, only the disinfection that is
considered necessary as per the hospital’s service plan is recommended. Before disinfecting
the equipment, clean it first.
For the disinfections of S p O
in VS-800 Operation Manual.
2
sensors, NIBP cuffs and TEMP probes, refer to relevant chapters
6-2
Maintenance and Cleaning
6.4 Cleaning/ Disinfection Solutions
Following are examples of cleaning/Disinfection solutions:
Alcohol based (Ethanol 70%, Isopropanol 70%)
aldehyde based
6.5 Contact Information for Maintenance and Technical