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.
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.
Contents of this manual are subject to changes without prior notice.
For this manual, the issued Date is January 2015 (Version 2.0).
, , and are the registered trademarks or trademarks owned by
WARNING
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.
Warranty
Mindray warrants that components within its products will be free from defects in
workmanship and materials for a period of three years from the date of purchase except that
disposable or one-time use products are warranted to be free from defects in workmanship
and materials up to a date one year from the date of purchase or the date of first use,
whichever is sooner.
This warranty does not cover consumable items such as, but not limited to, batteries,
external cables, and sensors.
Mindray shall not be liable for any incidental, special, or consequential loss, damage, or
expense directly or indirectly arising from the use of its products. Liability under this
warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or
replacing the affected products, at Mindray’s option, at the factory or at an authorized
distributor, for any product which shall under normal use and service appear to Mindray to
have been defective in material or workmanship. Recommended preventative maintenance,
as prescribed in the service manual, is the responsibility of the user and is not covered by
this warranty.
No agent, employee, or representative of Mindray has any authority to bind Mindray to any
affirmation, representation, or warranty concerning its products, and any affirmation,
representation or warranty made by any agent, employee, or representative shall not be
enforceable by buyer or user.
THIS WARRANTY IS EXPRESSLY IN LIEU OF, AND MINDRAY EXPRESSLY DISCLAIMS, ANY
OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF
MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE, AND OF
ANY OTHER OBLIGATION ON THE PART OF MINDRAY.
Damage to any product or parts through misuse, neglect, accident, or by affixing any
II
non-standard accessory attachments, or by any customer modification voids this warranty.
Mindray makes no warranty whatsoever in regard to trade accessories, such being subject to
the warranty of their respective manufacturers.
A condition of this warranty is that the equipment or accessories which are claimed to be
defective be returned when authorized, freight prepaid to Mindray DS USA, Inc., Mahwah,
New Jersey 07430 or its authorized representative. Mindray shall not have any responsibility
in the event of loss or damage in transit.
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 use of parts or accessories not
approved by Mindray or repairs by people other than Mindray authorized personnel.
This warranty does not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure events, such as (i) flood, fire and
earthquake or other similar elements of nature or acts of God; (ii) riots, war, civil
disorders, rebellions, or revolutions in any country; or (iii) any other cause beyond the
reasonable control of Mindray.
Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible.
Others not caused by instrument or part itself.
III
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
IV
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
It is recommended that the user should change the passwords for user maintenance and
configuration mode once they take ownership of the equipment.
1.1 Manual Information .................................................................................................................................... 1-1
1.2 Safety Information ....................................................................................................................................... 1-1
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
4.2.3 SpO2 test ............................................................................................................................................ 4-2
4.2.4 NIBP Test ............................................................................................................................................ 4-4
4.2.5 Temperature Test ............................................................................................................................ 4-6
4.2.6 Nurse Call Reply Performance Test .......................................................................................... 4-7
4.3 Electrical Safety and Other Tests ............................................................................................................ 4-8
4.3.1 Electrical Safety and Other Test Frequencies ....................................................................... 4-8
4.3.2 Electric Safety Tests ........................................................................................................................ 4- 8
4.3.3 Power-on Test .................................................................................................................................. 4-8
4.4.3 Software Version ........................................................................................................................... 4-11
4.4.4 Monitor Information ................................................................................................................... 4-12
5.2 Part Replacement ........................................................................................................................................ 5-1
5.3 Checking Equipment Status .................................................................................................................... 5-1
5.4 Checking Software Version ...................................................................................................................... 5-1
7.2 Main Unit ........................................................................................................................................................ 7-1
7.2.2 Parts List ............................................................................................................................................. 7-1
7.3 Front Housing Subassembly (Touchscreen) ...................................................................................... 7-2
7.3.2 Parts List ............................................................................................................................................. 7-3
7.4.2 Parts List ............................................................................................................................................. 7-4
7.5 Main Bracket Assembly ............................................................................................................................. 7-6
7.5.2 Parts List ............................................................................................................................................. 7-6
7.6 Power Management Board Assembly ................................................................................................. 7-7
7.6.2 Parts List ............................................................................................................................................. 7-7
7.7.2 Parts List ............................................................................................................................................. 7-8
7.8 Predictive Temperature Assembly ......................................................................................................... 7-9
7.8.2 Parts List ............................................................................................................................................. 7-9
8 Hardware and Software Upgrade ......................................................................................... 8-1
2.0 Modify temperature module test method, update parts list
1.2 Safety 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 operator’s manual for detailed operation and other information.
1-2
1.3 Equipment Symbols
Some symbols may not appear on your equipment.
Caution
Alternating current (AC)
Alarm Reset
Alarm Paused
Admit a new patient
DEFIBRILLATION –PROOF
TYPE CF APPLIED PART
Network connector
USB connectors
Serial number
DATE OF MANUAFACTURE
Power ON/OFF
Battery indicator
NIBP Start/Stop key
Record
Insertion Direction
Input/Output
Equipotentiality
Manufacturer
Protection against fluid ingress
CATALOGUE NUMBER
Temperature limit
Atmospheric pressure
limitation
AUTHORISED
REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
The product bears CE mark indicating its conformity with the provisions of the
Council Directive 93/42/EEC concerning medical devices and fulfills the
essential requirements of Annex I of this directive.
1-3
Humidity limitation
Refer to instruction manual/
booklet
Interference may occur in the
vicinity of equipment marked
with this symbol
The following definition of the WEEE label applies to EU member states only.
This symbol indicates that this product should not be treated as household
waste. By ensuring that this product is disposed of correctly, you will help
prevent bringing potential negative consequences to the environment and
human health. For more detailed information with regard to returning and
recycling this product, please consult the distributor from whom you purchased
it.
* For system products, this label may be attached to the main unit only.
The presence of this label indicates the machine was certified by ETL with the
statement:
Conforms to AAMI Std ES 60601-1, IEC Std 60601-1-6, IEC Std 60601-1-8, IEC Std
60601-2-49, IEC Std 80601-2-30, ISO Std 80601-2-56, ISO Std 80601-2-61.
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.
Monito
Nurse Call
Reserved port
Other device
Mindray Proprietary LAN
i
F
-
i
W
EMR Server
AP
CMS/Gatewa
The above figure shows a system consisting of the vital signs monitor and its peripheral 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
Hypervisor Central Monitoring System (hereinafter called CMS).
Supports external AC power source and an internal battery.
Supports clinical data acquisition: by SD card or by USB drive.
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, keypad board assembly (knob),
display, touchscreen, and alarm lamp board.
Rear housing assembly: power module (AC/DC), power management and interface
board (including SpO
board.
SpO
2
External module:Temperature module.
isolation power), recorder, speaker, battery, NIBP module, and
2
2-2
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
2.4 Front Housing Assembly
Alarm lamp board
Touchscreen
control board
Wi-Fi
antenna
Main board
Screws securing the front and rear housing
Wi-Fi
module
Keypad
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
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.
board, NIBP module, and Temperature module through
2
2-4
Keypad
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)
The Wi-Fi Module enables the equipment to connect to an 802.11 b/g/n Mindray proprietary
network.
2.6 Rear Housing Assembly
Speaker
Power
NIBP
module
Recorder
Rear housing assembly consists of power module (AC/DC), power management and interface
board (including SpO
isolation power), recorder, speaker, battery, NIBP module, and SpO2 board.
2
2-5
management
and interface
board
AC/DC
power
module
SpO2board
AC/DC Power Module
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, filter and protection for these connectors.
module; and,
2
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.
SpO2 Board
The SpO
to the main board. The power management interface board provides isolation power for it.
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 have been received.
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 America immediately.
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
Temperature (℃)
0 to 40 (without Temperature
module)
5 to 40 (with Temperature
module)
-30 to 70 10% to 95% 120.0 to 805.5
NOTE
The environmental specifications of unspecified accessories are the same as those of
the main unit.
Relative humidity
(noncondensing)
15% to 95% 427.5 to 805.5
Altitude (mmHg)
3-1
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
0.9 to 0.5A
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 of the vital signs monitor.
3. Connect AC power.
4. Connect the accessories.
Installation Support
The vital signs monitor can be mounted on a wall bracket or on a trolley support. The wall
bracket or trolley support 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
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