SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)
owns the intellectual property rights to this product and this manual. This manual may refer
to information 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.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution,
rent, adaption and translation of this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
, , and are the registered trademarks or trademarks owned by
Mindray in China and other countries. All other trademarks that appear in this manual are
used only for editorial purposes without the intention of improperly using them. They are
the property of their respective owners.
This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents:
http://www.mindrayna.com/patents.
The issued date for this manual is May 2019 (Version 11.0).
Federal Law (USA) restricts this device to sale by or on the order of a
physician.
NOTE
This manual describes all features and options. The equipment may not have
all of them. Contact Mindray service department for any questions.
I
Manufacturer’s Responsibility
Contents of this manual are subject to changes without prior notice.
All information contained in this manual 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 manual.
Mindray is responsible for safety, reliability and performance of this product only in the
condition that:
All installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray authorized personnel; and
The electrical installation of the relevant room complies with the applicable
national and local requirements; and
This product is operated under strict observance of this manual.
Return Policy
In the event that it becomes necessary to return a unit to Mindray, follow the instructions
below.
1. Obtain a return authorization.
Contact the Mindray Service Department and obtain a Mindray Customer Service
Authorization Number. The Mindray Customer Service Authorization Number
must appear on the outside of the shipping container. Return shipments will not
be accepted if the Mindray Customer Service Authorization 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 this product is shipped to
Mindray for service (including any relevant customs fees or other freight related
charges).
3. Return address
Please send the part(s) or equipment to the address offered by Customer Service
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan, Shenzhen 518057 P.R. China
+86 755 81888998
+86 755 26582680
www.mindray.com
Mindray DS USA, Inc.
800 MacArthur Boulevard Mahwah, New Jersey 07430 USA
1.800.288.2121, 1.201.995.8000
www.mindray.com
III
Preface
Manual Purpose
This manual provides detailed information about the assembling, dissembling, testing and
troubleshooting of the equipment to support effective troubleshooting and repair. It is not
intended to be a comprehensive, in-depth explanation of the product architecture or
technical implementation.
Observance of the manual is a prerequisite for proper equipment maintenance and
prevents equipment damage and personnel injury.
Intended Audience
This manual is for biomedical engineers, authorized technicians or service representatives
responsible for troubleshooting, repairing and maintaining the equipment.
Passwords
A password may be required to access different modes of the following equipment. The
passwords are listed below:
User maintenance: 888888
Configuration mode: 315666
Demo mode : Contact Mindray service personnel for the password
Factory maintenace: Contact Mindray service personnel for the password
It is recommended that the user should change the passwords for user maintenance and
configuration mode once they take ownership of the equipment.
2.2 Connectors for Peripheral Devices ..................................................................................... 2-2
2.3 Main Unit ..................................................................................................................................... 2-2
2.4 Front Housing Assembly ........................................................................................................ 2-4
2.5 Main Board .................................................................................................................................. 2-4
7.2 Main Unit ..................................................................................................................................... 7-1
Modify the description of equipment symbols, add the patent
information
WAR NIN G
Indicates a potential hazard or unsafe practice that, if not avoided, will result
in death or serious injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
NOTE
Provides application tips or other useful information to ensure that you get
the most from your product.
1-1
1.2.1 Warnings
WAR NIN G
All installation operations, expansions, changes, modifications and repairs of
this product are conducted by Mindray authorized personnel.
There is high voltage inside the equipment. Never disassemble the
equipment before it is disconnected from the AC power source or the
battery.
When you disassemble/reassemble a parameter module, a patient leakage
current test must be performed before it is used again for monitoring.
The equipment must be connected to a properly installed power outlet with
protective earth contacts only. If the installation does not provide for a
protective earth conductor, disconnect it from the power line and operate it
on battery power, if possible.
Disposal of the packaging material should observe the applicable waste
control regulations and keeping it out of children’s reach.
1.2.2 Cautions
CAUTION
Make sure that no electromagnetic radiation interferes with the
performance of the equipment when preparing to carry out performance
tests. Mobile phone, X-ray equipment or MRI devices are a possible source of
interference as they may emit higher levels of electromagnetic radiation.
Before connecting the receiver to the power line, check that the voltage and
frequency ratings of the power line are the same as those indicated on the
unit’s label or in this manual.
Protect the equipment from damage caused by drop, impact, strong
vibration or other mechanical force during servicing.
1.2.3 Notes
NOTE
Refer to the operator’s manual for detailed operation and other information.
1.3 Equipment Symbols
See theapplicable Operator’s Manual for information about the symbols used on this
product and its packaging.
1-2
y
2 Theory of Operation
2.1 Overview
The Monitor is intended for monitoring physiologic parameters, including SpO2, Pulse Rate,
NIBP and Temperature, on adult, pediatric, and neonatal patients in healthcare facilities by
clinical physicians or appropriate medical staff under the direction of physicians.
The equipment also:
Provides audible and visual alarm indications in case of patient or equipment
problems;
Provides display, review, storage and printing of monitored information;
Incorporates multiple input devices such as buttons, knob, and touchscreen; and,
Enables program upgrade over the network.
Monit or
Nurse Call
Reserved port
Other device
The above figure shows a system consisting of the vital signs monitor and its peripheral
Mindray Proprietary LAN
i
F
-
i
W
EMR Server
AP
CMS/Gatewa
devices. The vital signs monitor:
Can be used for monitoring the physiological parameters, giving alarms and
reviewing patient data, etc.
Supports recorder.
Supports nurse call function.
Supports Wi-Fi module, wired network, remote view, and communication with the
BeneVision Central Monitoring System (hereinafter called CMS) (only available for
the Accutorr 7).
Supports external AC power source and an internal battery.
Supports clinical data acquisition: by SD card
or by USB drive.
NOTE
Wi-Fi module is only available for the Accutorr 7.
2-1
2.2 Connectors for Peripheral Devices
1
2
3
4
5
6
1. Connector for Temperature probe
2. Network connector: It is a standard RJ45 connector used to communicate with
external devices, such as central monitoring system, e-Gateway, or used to export
data or upgrade the system.
3. Multi-function connector: connects to the hospital's nurse call system, or connects
external devices through DIAP protocol.
4. USB connector: connects to barcode scanner or USB disk.
5. AC Power Input
6. Equipotential grounding terminal: When the equipment and other devices are to
be used together, their equipotential grounding terminals should be connected
together to eliminate the potential difference between them.
2.3 Main Unit
The main unit of the vital signs monitor consists of three parts:
Front housing assembly: main board, Wi-Fi module (only available for Accutorr 7),
keypad board assembly (knob), display, touchscreen, and alarm lamp board.
Rear housing assembly: power module (AC/DC), power management and
The following figure shows the main unit architecture of the vital signs monitor.
Front Housing Assembly
Alarm lamp
board
Knob
Power
On/Off
keypad
(Indicator)
SD card
Main board
Wi-Fi module
I2C
LVD
S
Backlight
Touchscree
n control
board
LCD display
Touch
screen
Rear Housing Assembly
Speaker
Recorder
2600mAh
battery
15V
AC-DC power
module
AC-IN
Power
management
and interface
board
SpO
2
isolation power
External interface
RJ45/USB/Multifunctional
(nurse call, extended ports)
Pump
NIBP module
SpO2 board
(Standard
Mindray,OEM
optional)
NIBP socket
SpO2socket
External Module
Predictive
Temp
module
Temp
probe
2-3
T
2.4 Front Housing Assembly
Alarm lamp
board
ouchscreen
control
board
Main board
Keypad
Screws securing the front and rear housing
2.5 Main Board
The main board is the control center of the equipment. It provides communication, display,
and data storage functions, including:
Communication with SpO
through connector;
Communication with power management board, keypad board, and recorder
through connectors;
Providing drive for display and backlight;
Providing 2 USB connectors, a network connector, and a multifunctional
connector;
Communication with touchscreen control board through I2C;
Providing drive for SD card; and,
Providing drive for Wi-Fi module(only available for Accutorr 7).
board, NIBP module, andTemperature module
2
2-4
ypad
Ke
The keypad scans and detects the input of keys and encoder, integrates the power on/off
key, and connects AC and battery indicators.
Alarm Lamp Board
The alarm lamp board is located at the top of front housing. It has two-color indicators, red
and yellow. The alarm lamp board directly connects the main board through a cable. It is
controlled directly by the main board.
Touchscreen and Touchscreen Control Board
The touchscreen control board drives the touchscreen and implements communication
with the vital signs monitor.
Wi-Fi Module (Optional, Only Available for Accutorr 7)
The Wi-Fi Module enables the equipment to connect to an 802.11 a/b/g/n Mindray
proprietary network.
2.6 Rear Housing Assembly
Speaker
Power
NIBP
module
management
and interface
board
Recorder
AC/DC
power
module
SpO2 board
Rear housing assembly consists of power module (AC/DC), power management and
interface board (including SpO
and SpO
The AC/DC power board transforms the input AC into DC power, which is the power source
for all voltages in the equipment.
Power Management
and Interface Board
The power management and interface board provides the following functions:
Charge and discharge of battery and charge detection;
DC/DC conversion: outputs 12V and 5V DC power;
Control over power on/off key and AC, BAT indicator;
Communication transmission among parameter modules;
Providing isolation power for SpO
Providing external connectors
module; and,
2
, filter and protection for these connectors.
Recorder
The recorder receives data from the main board and sends them to the thermal printhead
for printing.
NIBP Module
The NIBP module consists of blood pressure measurement board and pump and valve
assembly, providing measurement acquisition of blood pressure data. The main functions of
the NIBP module are:
NIBP measurement; and,
Data exchange with the main board.
Board
SpO
2
The SpO2 board collects SpO2 signals, processes SpO2 algorithm and sends measurement
results to the main board. The power management interface board provides isolation power
for it.
CO
Module (Only Available for Accutorr 7)
2
CO
concentration of CO
of specific wavelengths. The main functions of the CO
monitoring is a continuous, non-invasive technique for determining the
2
in the patient’ airway by measuring the absorption of infrared (IR) light
2
module are:
2
Provides a CO2 waveform, and EtCO2, FiCO2, awRR measurement; and
Data exchange with the main board through the serial ports.
2.7 External Module
An external Temp module can be attached to the monitor.
The independently developed Mindray Temperature module consists of an isolation power
board, Temperature measurement board, and probes. The Temperature measurement
board collects Temperature signals, processes algorithm and sends measurement results to
the main board.
2-6
3 Equipment Installation
3.1 Unpacking the Equipment
Open the package and take out the packing list. Check that all the articles included in the
packing list are available and the quantity and specification are correct. Make sure that:
All the optional parts purchased by the customer
Notify Mindray North America if your order is incorrect or is incomplete.
In case of damage during transportation, keep the packing material and notify
Mindray North Americaimmediately.
Keep the packing material until all equipment is checked and accepted.
3.2 Preparation for Installation
3.2.1 Preparation for Installation Site
1. Ensure that the site meets all safety, environmental and power requirements.
2. Ensure that a network connector is available if the equipment needs to be
connected to network.
3.2.2 Environmental Requirements
To avoid explosion hazard, do not use the equipment in the presence of flammable
anesthetics, vapors or liquids. The environment where the equipment will be used should
be reasonably free from vibration, dust and corrosive substances. If these conditions are not
met, the system may not function normally.
The environmental specification is as follows:
Main Unit
Item
Operating
environment
Storage
environment
NOTE
The environmental specifications of unspecified accessories are the same as
Temperature (℃)
0 to 40 (without Temp
module)
5 to 40 (with SmarTemp module)
16 to 40 (with Exergen Temp
module)
-30 to 70
-20 to 50 (with Exergen Temp
module)
erature
have been received.
Relative humidity
(noncondensing)
15% to 95% 427.5 to 805.5
10% to 95% 120.0 to 805.5
Altitude
(mmHg)
3-1
those of the main unit.
3.2.3 Electrical Requirements
Check cables and power cords. Make sure that:
1. System cables, power cords, and power plugs are not damaged, and that the pins
are not loose. If damage is noted, discontinue use and replace.
2. Patient cables and connections are secure.
WARNING
Use only properly grounded power outlets.
Use the supplied power cord only!
Vol tage
Current
Frequency
100 to 240V AC
to 0.5A
0.9
50/60 Hz
3.3 Equipment Installation
Follow the procedure below to install the equipment:
1. Ensure the unit and accessories are not damaged.
2. Install the battery (optional). For detailed operations, please refer to the operator’s
manual.
3. Connect AC power.
4. Connect the accessories.
Installation Support
The vital signs monitor can be mounted on a wall bracket or on a rolling stand. The wall
bracket or rolling stand can be ordered optionally. Each type of mounting bracket is
delivered with a complete set of mounting hardware and instructions. For detailed
installation information, please refer to Wall-mount Bracket Instructions for Use (PN: 0010-20-42933) and Rollstand Instructions for Use (PN: 0010-20-42934).
CAUTION
Use only Mindray supplied or approved mounting solutions.
The mounting bracket should be installed by qualified service personnel.
3-2
3.3.1 Preparation for Power on
1. Before using the equipment, check for any mechanical damage and make sure
that all external cables, plug-ins and accessories are properly connected.
2. Plug the power cord into the AC power source. If you run the equipment on
battery power, ensure that the battery is sufficiently charged.
3. Press the Power ON/OFF button (
equipment.
) on the front panel to turn on the
3-3
FOR YOUR NOTES
3-4
4 Testing and Maintenance
4.1 Introduction
The expected service life of the equipment is five years. To ensure the equipment always
functions normally, qualified service personnel should perform regular inspection,
maintenance and test. This chapter provides a checklist of the testing procedures for the
equipment with recommended test equipment and frequency. The service personnel
should perform the testing and maintenance procedures as required and use appropriate
test equipment.
The testing procedures provided in this chapter are intended to verify that the equipment
meets the performance specifications. If the equipment or a module fails to perform as
specified in any test, repairs or replacements must be done to correct the problem. If you
have any question, contact our Technical Support Department.
CAUTION
All tests should be performed by qualified service personnel only.
Care should be taken to avoid changing the settings in [User Settings >>] and
[Factory Maintenance >>] menus to avoid loss of data.
Service personnel should acquaint themselves with the test tools and make
sure that test tools and cables are available.
4.2 Performance Tests
Performance test are designed to ensure that measurement results are accurate. The
following sections provide a list of performance and accuracy tests and their recommended
frequencies.
4-1
4.2.1 Performance Test Frequencies
Check/Maintenance Item Frequency
Visual inspection 1. When first installed or reinstalled.
SpO2test
Leakage test
NIBP test
CO2 test
(Accutorr 7 only)
TEMP test
Accuracytest
NIBP cuff
overpressure test
Performance test
Calibration
Exergen
TemporalScanner
thermometer
1. If the user suspects that the measurement is
incorrect.
2. Following any repairs or replacement of
relevant module.
3.
Every two years for SmarTemp
and SpO
4.
test.
2
Per year is recommended for NIBP and CO
TM
module test
2
tests.
SmarTempTM
module
4.2.2 Visual Inspection
Perform an overall inspection on the appearance of the equipment. The test is passed if the
equipment has no obvious signs of damage. Follow these guidelines when inspecting the
equipment:
Carefully inspect the case, display screen, buttons, and knob for obvious signs of
damage.
Inspect all external connections for loose connectors, bent pins or frayed cables.
Inspect all connectors on the equipment for loose connectors or bent pins.
Make sure that safety labels and data plates on the equipment are clearly legible.
4.2.3 SpO
Test Met ho d 1
Tool required:
None
Test procedure:
1. Connect SpO
2. Place the SpO
3. Verify the Pleth Wave and Pulse Rate are displayed on the screen.
4. Remove the SpO
test
2
sensor for adult to the SpO2 connector of the monitor. Set [Patient
2
Category
] to [Adult].
sensor on your finger.
2
alarm is triggered.
sensor from your finger and make sure that the SpO2 Sensor Off
2
4-2
Measurement validation
The SpO2 accuracy has been validated in human studies against arterial blood sample
reference measured with a CO-oximeter. Pulse oximeter measurements are statistically
distributed, and only about two-thirds of the measurements can be expected to fall within
the specified accuracy compared to CO-oximeter measurements.
NOTE
The SpO2 simulator can only be used to verify that the pulse oximeter
operates properly. It cannot be used to verify the accuracy of the pulse
oximeter or the SpO2 sensor. To verify the accuracy, clinical tests are
required.
Test Met ho d 2
Tool required:
SpO
simulator, Index-2 recommended
2
Test procedure:
1. Connect the SpO
sensor to the SpO2 simulator.
2
2. Selected the model and manufacturer of the SpO2 module to be tested on the
simulator, and set the simulator as follows: SpO
to 96% and Pulse Rate to 80 bmp.
2
3. Set the patient type to [Adult], [Pediatric], and [Neonatal] respectively. Observe
the monitor and make sure the displayed SpO
and Pulse Rate value fall in the
2
following range.
Manufacturer SpO2 Pulse Rate
Nellcor
Masimo
96% ± 2% (Adult, pediatric)
96% ± 3% (Neonate)
96% ± 2% (Adult, pediatric)
96% ± 3% (Neonate)
80 ± 3 bpm
80 ± 3 bpm
4-3
4.2.4 NIBP Test
Leakage Test
NOTE
Perform NIBP leakage test before any other NIBP test and calibration.
ools required:
T
Adult NIBP Cuff
NIBP Hose
Cylinder
Follow this procedure to perform the
leakage test:
1. In the [Patient Demographics] menu, set [Patient Category] to [Adult].
2. Connect the NIBP cuff to the NIBP connector on the monitor.
Leakage Testing…] is displayed in the NIBP parameter area.
[
Module Maintenance >>]→[NIBP Leakage Test]. The message
After about 20 seconds, the monitor will automatically deflate. This means the test is
complete. If no message is displayed in the NIBP parameter area, it indicates that the system
has no leakage. If the message [
NIBP Pneumatic Leak] is displayed, it indicates that the
system may have a leak. Check the tubing and connections for leakages. Ensure that the
tubing and connections are all correct, perform a leakage test again. If the problem persists,
contact our Technical Support Department.
You may also perform a manual leakage test:
1. Perform steps 1 to 4 in the NIBP Accuracy Test section.
2. Raise the pressure in the rigid vessel to 250 mmHg with the manometer bulb.
Then, wait for 5 seconds to allow the pressure to stabilize.
3. Record the current pressure value, wait 60 seconds and record the pressure again.
4. Compare the two pressure values and verify the difference is 6mmHg or less.
4-4
NIBP Accuracy Test
Tool required:
T-shape connector
Appropriate tubing
Manometer bulb
Rigid Vessel with volume 500 ± 25 ml
Reference manometer (calibrated with accuracy equal to or better than 0.75
mmHg)
Follow this procedure to perform the accuracy test:
1. Connect the equipment as shown below.
Monitor
Standard
sphygmomanometer
Connector for NIBP cuff
Manometer bulb
Appropriate tubing
Rigid Vessel
2. Before inflation, check that the reading of the manometer is 0. If not, turn off the
manometer bulb to let the whole airway open to the atmosphere. Turn on the
manometer bulb after the reading is 0.
4. Check the manometer values and the monitor values. Both should be 0 mmHg.
5. Raise the pressure in the rigid vessel to 50 mmHg with the manometer bulb. Then,
wait for 10 seconds to let the measured values become stable.
6. Compare the manometer values with the monitor values. The difference between
the manometer and displayed values should be ± 3 mmHg. If it is greater than ± 3
mmHg, contact Mindray Technical Support.
7. Raise the pressure in the rigid vessel to 200 mmHg with the manometer bulb.
Then, wait for 10 seconds to let the measured values become stable. Repeat step
6.
NOTE
You can use an NIBP simulator to replace the manometer bulb and the
reference manometer to perform the test.
4-5
Cuff OverpressureTes t
NIBP
Tools required:
T-shape connector
Appropriate tubing
Manometer bulb
Metal Vessel with volume 500 ± 25 ml
Reference manometer (calibrated, with accuracy equal to or better than 0.75
mmHg)
Follow this procedure to perform the calibration:
1. Perform steps 1 to 4 in the NIBP Accuracy Test section.
2. Select [
Main]→[Maintenance >>]→[Factory Maintenance >>]→enter the required
3. In [Overpressure Protection Circuit] menu, set [Patient Category] to [Adu/Ped].
Raise the pressure to 330 mmHg. After the pressure value is stabilized, select
[Calibrate] to start calibration.
4. In the [
Overpressure Protection Circuit] menu, set [Patient Category] to
Neonatal]. Raise the pressure to 165 mmHg. When the pressure value is stabilized,
[
select [
Calibrate] to start calibration.
5. All calibration results are displayed in the [Calibrate NIBP] menu. If the calibration
fails, check the test system for leakage and perform another calibration.
3. Open the valve to start flowing CO
to atmosphere.
4. Verify the realtime CO
2 value is within 5.0 ± 0.3% in the [Calibrate CO2] menu.
Tubing
Monitor
2 and make sure that there is sufficient flow to vent
4-7
T
T
CO2 Calibration
Tools required:
A steel gas cylinder with 5% CO
2, 21% O2, and balance gas N2 (P/N 0075-00-0033-01)
T-shape connector
Tubing
1. Select [
Main]→ [Maintenance >>]→[User Maintenance>>]→enter the required
password→ [
Module Maintenance>>]→[Calibrate CO2>>].
2. In the [Calibrate CO2] menu, select [Zero].
3. After the zero calibration is finished successfully, connect the equipment as follows:
Relief valve
-shape connector
ubing
Monitor
Cylinder
4. Open the valve to start flowing CO
2 and make sure that there is sufficient flow to vent
to atmosphere.
5. In the [Calibrate CO2] menu, enter the CO
6. In the [Calibrate CO2] menu, the measured CO
measured CO
2 module.
CO
2 concentration becomes stable, select [Calibrate CO2] to calibrate the
2 concentration in the [CO2] field.
2 concentration is displayed. After the
If the calibration is completed successfully, the message [Calibration Completed!] is
displayed in the [Calibrate CO2] menu. If the calibration fails, the message [Calibration Failed ] is displayed. In this case, attempt to calibrate the CO
2 module again.
4-8
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