ePM 10 and 12 Series Service Manual ver1.0 Dec 2018

Intellectual Property Statement 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.

,

, and

are the registered trademarks or trademarks owned by Mindray

in China and other countries.

Revision History This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. 

Version number

1.0



Release time:

December 2018

© 2018 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

I

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 monitors.

Passwords A password may be required to access different modes. The passwords are listed below: 

User maintenance:



Manage Configuration: 315666



Factory maintenance:

332888



Demo mode:

2088

888888

II

Contents 1 Safety ... 1-1 1.1 Safety Information... 1-1 1.1.1 Warnings ... 1-1 1.1.2 Cautions ... 1-2 1.1.3 Notes ... 1-3 1.2 Equipment Symbols ... 1-3 2 Product Principle ... 2-1 2.1 Overview ... 2-1 2.2 Product System Structure ... 2-1 2.2.1 Main Control Board/Parameter/Interface Board ... 2-3 2.2.2 Integral Module Rack Backboard ... 2-3 2.2.3 Power Supply Architecture ... 2-4 2.2.4 Alarm Indicator Light Board ... 2-4 2.2.5 Power On/Off Button Board/Shortcut Button Board ... 2-5 2.3 Data Logic flow ... 2-5 2.4 Power On/Off Signal Flow Diagram ... 2-6 3 Wireless LAN (WLAN) Installation ... 3-1 3.1 Introduction... 3-1 3.2 Network Deployment Process ... 3-1 3.2.1 Output List ... 3-2 3.3 Network Requirements ... 3-3 3.4 Network Inspection and Acceptance ... 3-4 3.4.1 Tools and Resources... 3-4 3.4.2 WiFi Signal Calibration ... 3-5 3.4.3 Network Inspection and Acceptance Process ... 3-5 3.5 Use Patient Monitors to Assess Network Coverage ... 3-8 3.6 Recommended Network Equipment ... 3-9 3.7 Seting the Wireless Parameters of the Patient Monitor ... 3-9 3.8 Troubleshooting ... 3-12 4 Testing and Maintenance ... 4-1 4.1 Introduction... 4-1 4.1.1 Test Device ... 4-1 4.1.2 Test Report ... 4-1 4.1.3 Preventive Maintenance ... 4-1 4.1.4 Recommended Frequency ... 4-2 4.2 Preventive Maintenance ... 4-3 4.2.1 Visual Inspection ... 4-3

1

4.2.2 NIBP Test... 4-4 4.2.3 Sidestream and Microstream CO2 Testing and Calibration... 4-6 4.2.4 AG Testing and Calibration ... 4-8 4.3 Power On Test ... 4-11 4.4 Module Performance Test ... 4-11 4.4.1 ECG Test ... 4-11 4.4.2 Resp Test ... 4-12 4.4.3 SpO2 Test ... 4-12 4.4.4 NIBP Test... 4-13 4.4.5 Temp Test ... 4-13 4.4.6 IBP Test ... 4-13 4.4.7 C.O. Test ... 4-15 4.4.8 Mainstream CO2 Test... 4-16 4.4.9 Sidestream and Microstream CO2 Testing and Calibration... 4-17 4.4.10 AG Test and Calibration ... 4-17 4.4.11 BIS Test ... 4-17 4.5 Nurse Call Test ... 4-18 4.6 Analog Output Test ... 4-19 4.7 Electric Safety Test ... 4-19 4.7.1 Housing Leakage Current Test ... 4-20 4.7.2 Earth Leakage Current Test ... 4-21 4.7.3 Patient Leakage Current Test ... 4-21 4.7.4 Patient Auxiliary Current Test ... 4-21 4.8 Recorder Check ... 4-22 4.9 Network Printing check ... 4-22 4.9.1 Equipment Connection and Setup ... 4-22 4.9.2 Printing Function Test ... 4-22 4.10 Battery Check... 4-23 4.11 Charging Dock Check ... 4-23 4.12 Factory Maintenance ... 4-23 4.12.1 Enter Factory Maintenance... 4-23 4.12.2 Monitor Information (Exporting Log) ... 4-23 4.12.3 Production Test ... 4-24 4.12.4 Setup... 4-24 4.12.5 Debugging ... 4-24 4.12.6 Power Information ... 4-24 4.12.7 Clinical Data ... 4-24 4.12.8 Sending Clinical Data ... 4-24 4.12.9 Software Version ... 4-24 5 Troubleshooting ... 5-1 5.1 Introduction... 5-1 5.2 Component Replacement ... 5-1 5.3 Checkup before Starting the Monitor ... 5-1

2

5.4 Software Version Check ... 5-1 5.5 Technical Alarm Messages... 5-1 5.5.1 General Technical Alarm Messages ... 5-2 5.5.2 ECG Technical Alarm Messages... 5-2 5.5.3 Resp Technical Alarm Messages ... 5-3 5.5.4 SpO2 Technical Alarm Messages ... 5-3 5.5.5 Temp Technical Alarm Messages... 5-4 5.5.6 NIBP Technical Alarm Messages ... 5-4 5.5.7 IBP Technical Alarm Messages ... 5-5 5.5.8 C.O. Technical Alarm Messages ... 5-6 5.5.9 CO2 Technical Alarm Messages ... 5-6 5.5.10 AG Technical Alarm Messages ... 5-8 5.5.11 BIS Technical Alarm Messages ... 5-8 5.5.12 Power Supply Technical Alarm Messages ... 5-9 5.5.13 Recorder Technical Alarm Messages ... 5-10 5.5.14 Printer Technical Alarm Messages ... 5-10 5.5.15 Technical Alarm Messages Related to Networked Monitoring ... 5-11 5.5.16 Other System Technical Alarm Messages ... 5-11 5.6 Troubleshooting Guide... 5-12 5.6.1 Problems with Turning on/off ... 5-12 5.6.2 Display Failures ... 5-15 5.6.3 Module Rack Failures ... 5-16 5.6.4 Alarm Failures... 5-17 5.6.5 Recorder Failures... 5-17 5.6.6 Output Interface Failures ... 5-18 5.6.7 Battery Failures ... 5-18 5.6.8 Parameter Module Failures ... 5-18 5.6.9 Network Failures ... 5-20 5.6.10 Software Upgrade Failures... 5-21 6 Upgrade ... 6-1 6.1 Introduction... 6-1 6.2 Parameter Function Module Upgrade ... 6-1 6.3 Upgrading Parameter C.O. Function Module ... 6-2 6.4 Upgrading the Gas Module ... 6-3 6.5 Function Component Upgrade ... 6-5 6.5.1 Upgrading WiFi Function ... 6-5 6.5.2 Upgrading Recorder Function ... 6-6 6.6 Software Upgrade ... 6-7 6.6.1 Network Upgrade Tool ... 6-9 6.6.2 Software Upgrade ... 6-12 6.6.3 Upgrade by USB Disk... 6-13 7 Maintenance and Disassembly ... 7-1

3

7.1 Tool... 7-1 7.2 Preparations... 7-1 7.3 ePM 12M/ePM 12MA/ePM 12MC Front/Rear Housing and Bottom Housing Disassembly ... 7-2 7.3.1 Disassembling Battery Box Component (Configured) ... 7-2 7.3.2 Disassembling Front/Rear Housing and Bottom Housing ... 7-3 7.3.3 Disassembling Front Housing Component ... 7-4 7.3.4 Disassembling Rear Housing Component ... 7-7 7.3.5 Disassembling Module Rack... 7-17 7.4 ePM 10M/ePM 10MA/ePM 10MC Front/Rear Housing and Bottom Housing Disassembly ... 7-18 7.4.1 Disassembling Front/Rear Housing and Bottom Housing ... 7-18 7.4.2 Disassembling Front Housing Component ... 7-20 7.4.3 Disassembling Rear Housing Component ... 7-23 7.4.4 Disassembling Module Rack... 7-29 8 Parts ... 8-1 8.1 ePM 12M/ePM 12MA/ePM 12MC Parts ... 8-1 8.1.1 System Structure ... 8-1 8.1.2 Front Housing ... 8-2 8.1.3 Rear Housing ... 8-3 8.2 ePM 10M/ePM 10MA/ePM 10MC Parts ... 8-4 8.2.1 System Structure ... 8-4 8.2.2 Front Housing ... 8-5 8.2.3 Rear Housing ... 8-6 8.3 ePM 12M/ePM 12MA/ePM 12MC/ePM 10M/ePM 10MA/ePM 10MC Main Bracket Component... 8-7 A Electrical Safety Inspection... A-1 A.1 Power Cord Plug ... A-1 A.1.1 The Power Plug ... A-1 A.2 Device Enclosure and Accessories ... A-2 A.2.1 Visual Inspection... A-2 A.2.2 Contextual Inspection ... A-2 A.3 Device Labeling ... A-2 A.4 Protective Earth Resistance ... A-2 A.5 Earth Leakage Test ... A-4 A.6 Patient Leakage Current ... A-5 A.7 Mains on Applied Part Leakage ... A-7 A.8 Patient Auxiliary Current ... A-9

4

1 Safety 1.1 Safety Information WARNING 

Indicates a potential hazard or unsafe practice that, if not avoided, could 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 Warnings WARNING 

This equipment is used for single patient at a time.



This equipment and its accessories are suitable for use within the patient environment.



To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents.



Use and store the equipment in specified environmental condition. The monitor and accessories may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range.



The equipment is not intended to be used within the Magnetic Resonance (MR) environment.



Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or in this manual.



Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition.

1-1



To avoid risk of electric shock, the equipment must only be connected to mains power with protective earth. If a protective earth conductor is not provided, operate it on battery power, if possible.



Do not use the multiple portable socket outlets (MPSO) or AC mains extension cords. Insure that the sum of the individual ground leakage currents does not exceed the allowable limits.



Do not touch the patient and live parts simultaneously. Otherwise patient injury may result.



Do not come into contact with the patient during defibrillation. Otherwise serious injury or death could result.



Do not open the equipment housings. All servicing and future upgrades must be carried out by trained and authorized personnel.



Do not rely exclusively on the audible alarm system for patient monitoring. Turning the alarm volume to a low level or off may result in a hazard to the patient. Remember that alarm settings should be customized according to patient situations. Always keep the patient under close surveillance.



The physiological data and alarm messages displayed on the equipment are for reference only and cannot be directly used for diagnostic interpretation.



Route, wrap and secure the cables to avoid inadvertent disconnection, stumbling and entanglement.



The software equipment copyright is solely owned by Mindray. No organization or individual shall resort to modifying, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.

1.1.2 Cautions CAUTION 

Use only parts and accessories specified in this manual.



Ensure that the equipment is supplied with continuous electric power during work. Sudden power failure may cause data loss.



Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.



Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.



Dry the equipment immediately in case of rain or water spray.



Some settings are password protected and can only be changed by authorized personnel. Contact your department manager or biomedical engineering department for the passwords used at your facility.

1-2



Dispose of the package material as per the applicable waste control regulations. Keep it out of children’s reach.



At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact us.

1.1.3 Notes NOTE 

Put the equipment in a location where you can easily view and operate the equipment.



The equipment use a mains plug as isolation means to the mains power. Do not locate the equipment in a place difficult to operate the mains plug.



The typical operator's position is in front of the monitor.



The software was developed in compliance with IEC62304. The possibility of hazards arising from software errors is minimized.



This manual describes all features and options. Your equipment may not have all of them.



Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.

1.2 Equipment Symbols See the ePM Series Patient Monitor Operator’s Manual (P/N: 046-012607-00) for information about the symbols used on this product and its packaging.

1-3

FOR YOUR NOTES

1-4

2 Product Principle 2.1 Overview The ePM series multi-parameter monitors enable to provide complete patient management, adequate physiological parameter monitoring and physiological alarm, possessing powerful data review function, flexible wired or wireless network configuration and application ability. It provides a series of CAA applications to assist physicians to make a diagnosis. Meanwhile, the ePM series provide hospital management with superior monitor management applications to help hospitals to improve the efficiency and quality of monitor equipment management. Based on the needs of clinical applications, ePM series could provide product models with displays of different sizes. Users can operate the monitor by touch screen or shortcut key. The product is compatible with the current BeneView T/BeneVision N series plug-in modules IBP, CO2, AG and C.O. as well as related accessories. The ePM series have good human-computer interaction design, clinical applicability, complete hospital IT solution capabilities and lots of CDS applications.

2.2 Product System Structure The ePM series monitors have only one main unit: 

ePM 10M/ePM 10MA/ePM 10MC host uses 10.1" TFT WXGA display



ePM 12M/ePM 12MA/ePM 12MC host uses 12.1" TFT WXGA display



Both of them use a touch screen and shortcut buttons as input devices, with an optional remote control



The host integrates a 2-slot integral module rack



Optional WiFi module



Optional built-in recorder

2-1

LCD/Touch Screen

Alarm indicator light board

ON/OFF button board/ shortcut button board

Speaker WiFi module

Main control/multi-parameter/ interface board Parameter module (built-in, optional)

AC-DC module

Recorder (built-in, optional) DC_IN

2*USB

VGA

RJ45

Multi-purpose connector

Fig. 2-1 System Block Diagram

2-2

Battery interface board

AC-DC connector

Battery

2.2.1 Main Control Board/Parameter/Interface Board The main control board includes the main control CPU, program memory, data memory, system configuration memory, WiFi module (optional), power management MCU, charging circuit for batteries and DC-DC circuit. A multi-parameter module circuit (ECG/Resp/SpO2/NIBP/IBP) is also integrated on this board. In addition, there are internal and external interfaces. The internal interfaces include an interface for the recorder, an interface for the integral module rack backboard, an internal parameter module interface, an interface between the AC-DC and the battery. The external interfaces include a VGA display interface, a USB interface, an Ethernet interface and a multi-function interface. Internal card cage backboard (for model M only)

SPI

MMC

E2ROM

DDR3 I2C

RTC

MMC Alarm indicator light

Touch Screen

I2C SPI

E2ROM

USB

USB hub

LCDC

RGB-LVDS

Main processor

Light sensor

USB 2*port

Audio codec/AMP

Speaker Power button/power indicator light

Parameter module(built-in)

Program memory

Main control/ parameter/ interface

Data memory

Touch screen controller

Shortcut button

WiFi � optional�

Power M0

RJ-45

UART

LCD VGA transfer

PHY

UAR T

UART/RS232

Nurse call/RS232 Multi-purpose connector

Analog Output

VGA interface

Backlight drive

Parameter processor

Parameter acquisition circuit

Fig. 2-2 Main Control Board Block Diagram

2.2.2 Integral Module Rack Backboard The host has an integral module rack backboard that supports a 2-slot module. Its main functions include: providing an interface for communication with the parameter module, and the interfaces for the above communication include: an infrared communication interface, a pog-pin interface and a power interface.

2-3

2.2.3 Power Supply Architecture Poweswitch board

LCD&TP

+5V/+3.3V

Photo Alarm lamp board senseor

Led driver

+3.3V

+3.3V_1

+5V

Isolation Power module

M0

+1.1V +1.8V

ON/OFF

100～240V AC

15V DC

AC/DC module

VBUS： 9.6～11.1V, +15V

AC-DC in

LDO ON/OFF DC/DC_1

+12V

ON/OFF

+1.325V +3.3V

DC_in

1st Battery

BAT charger

DC/DC_ 2

DC/DC +1.35V +1.1V _3

+5V

+1.8V

BAT switch

+12V

2nd Battery

DC/DC DC/DC Internal module rock COM board

+12V

+5V

Parameter module(integrated internally)

+12V

Recorder

Fig.2-3 Power Supply Architecture Diagram The AC/DC power module outputs 15V to the main control board. By the internal DC-DC_2 and DC_DC_1 conversion circuits of the main control board, it can generate 3.3V, 5V and 12V to supply power for other modules or boards in the host. The battery charging circuit is powered by 15V and can be switched between AC power supply and battery power supply by AC connection test. The ePM 12M/ePM 12MA/ePM 12MC support dual batteries. The first battery is installed in the main unit and the second battery is installed in the external battery compartment. The external battery compartment is installed at the bottom of the main unit. The ePM Series monitors support 3 types of batteries, 2600mAh, 4500mAh and 5600mAh. 2600mAh and 4500mAh are interchangeable. 5600mAh cannot be used interchangeably with these two batteries. +12V is the power supply for the integral module rack, recorder and parameter acquisition circuit. The power module for parameter acquisition adopts the DC-DC isolation design. DC_DC_3 is used to power the main processor.

2.2.4 Alarm Indicator Light Board There are LED alarm indicator lights and light sensors (optional) on the board. The light sensors conduct ambient light detection in order to adjust the brightness of LCD background light.

2-4

2.2.5 Power On/Off Button Board/Shortcut Button Board There are ON/OFF buttons and 3 indicator lights on the ON/OFF button board. They are the AC connection indicator light, the battery indicator light, and the power-on indicator light. The shortcut button board of has 4 shortcut buttons.The power switches, indicator lights and shortcut buttons are integrated on one board.

2.3 Data Logic flow Display and user interface

Data acquisition

System application

Data forwarding

Data output

Data storage Fig.2-4 Data Flow Diagram The monitoring parameters are collected and analyzed by the module and then forwarded to the system software via an integral or external module rack. The system software displays waveforms, values and alarms, meanwhile the data, alarms and values will also be stored in the internal data memory. It can also be sent to a central station or other monitors via network (wired or wireless).

2-5

2.4 Power On/Off Signal Flow Diagram Power supply management MO Normal power supply and power-on

No

If power button is turned on

Yes

Turn on the 12V power (power on infrared backboard/recorder/parameter module) Turn on the 5V/3.3V power (power on main control/USB port/display/touch screen) Power ON/OFF chart

2-6

Power supply management MO running process

Runs properly

Whether the Battery voltage is lower than the power-off voltage?

No

No

Yes

Whether the power Button is kept being pressed for more than 3s？

Yes

Send a request for poweroff to the main control

Whether the power-off request is received?

Yes

No

Whether the power button is kept being pressed for more than 10s/waiting for more than 10s

Yes

Turn off the main power supply

Power OFF process.

2-7

FOR YOUR NOTES

2-8

3 Wireless LAN (WLAN) Installation 3.1 Introduction This section describes how to install the Wireless LAN (WLAN) for Mindray patient monitor.

3.2 Network Deployment Process If the hospital has established a WLAN, follow the installation process below:

Mindray Marketing Agency or Sales Staff

A0 Providing network requirements

Mindray Headquarters

A1 Communication with hospitals on the intention to order

Mindray Acting Servant

A2 Communication with hospitals on network requirements and require hospitals to set up and adjust accordingly

A3 On-site adjustment

Pass/Fail

Pass A4 Conclusion of a contract

A5 Device installation and commissioning

Fig. 3-1 Network deployment flow chart

3-1