iMEC 12, 10, 8 Service Manual ver 4.0 July 2013

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.

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, adaptation 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.

Contents of this manual are subject to changes without prior notice.

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. „

Revision number:

4.0

„

Release time:

July 2013

© 2011 - 2013 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.

This manual is based on the maximum configuration; therefore, some contents may not apply to your monitor. If you have any question, please contact our Customer Service Department.

Intended Audience This manual is for biomedical engineers, authorized technicians or service representatives responsible for troubleshooting, repairing and maintaining the patient monitors.

Abbreviations Abbreviations used in this manual are: CMS

central monitoring system

PCB

printed circuit board

Passwords A password may be required to access different modes within the monitor. The passwords are listed below: „

User maintenance:

888888 (User adjustable)

„

Factory maintenance:

332888

„

Demo mode:

2088

„

Configuration mode:

315666 (User adjustable)

II

Table of Contents 1 Safety... 1-1 1.1 Safety Information ...1-1 1.1.1 Dangers ...1-2 1.1.2 Warnings ...1-2 1.1.3 Cautions ...1-2 1.1.4 Notes ...1-2 1.2 Equipment Symbols ...1-3

2 Theory of Operation ... 2-1 2.1 Introduction ...2-1 2.2 System Connections...2-2 2.2.1 Installation Support ...2-2 2.2.2 Connectors for Peripheral Devices ...2-3 2.3 Main Unit ...2-4 2.4 Front Housing Assembly...2-5 2.4.1 Main Board ...2-5 2.4.2 Keypad and the Navigation Knob...2-6 2.4.3 Power On/Off and LED Indicator Board...2-7 2.4.4 Alarm Lamp Board...2-7 2.4.5 Display ...2-7 2.4.6 Touchscreen and Touchscreen Control Board ...2-7 2.5 Rear Housing Assembly ...2-7 2.5.1 AC/DC Power Board ...2-8 2.5.2 Interface Board (DC/DC, Power Management Circuit) ...2-8 2.5.3 Battery Back Board ...2-9 2.5.4 Parameter Module... 2-10 2.5.5 Multi-parameter Module... 2-10 2.5.6 SpO2 Board ... 2-11 2.5.7 C.O. Module... 2-11 2.5.8 CO2 Module ... 2-11 2.5.9 Recorder ... 2-12 2.6 Speaker... 2-12

3 Unpacking and Installation ... 3-1 3.1 Unpacking the Equipment...3-1 3.2 Preparation for Installation ...3-2 3.2.1 Preparation for Installation Site ...3-2 3.2.2 Electrical Requirements...3-3 3.2.3 Monitor Installation...3-3 3.2.4 Preparation for Power on ...3-3 1

4 Hardware and Software Upgrade... 4-1 4.1 Introduction... 4-1 4.2 Hardware Upgrade ... 4-1 4.2.1 Upgrading the 1G SD Storage Card ... 4-1 4.2.2 Upgrading Touchscreen... 4-2 4.2.3 Upgrading Wi-Fi ... 4-3 4.2.4 Upgrading Recorder... 4-4 4.2.5 Upgrading CO2... 4-5 4.2.6 Upgrading C.O. ... 4-8 4.2.7 Upgrading IBP... 4-9 4.2.8 Upgrading VGA/USB/Multi-functional Interface... 4-9 4.3 Software Upgrade...4-11 4.3.1 Installing Mindray Patient Monitor Software Upgrade Tool (PN: G-110-000493-00)...4-11 4.3.2 Software Upgrade Procedure...4-13

5 Testing and Maintenance ... 5-1 5.1 Introduction... 5-1 5.1.1 Test Equipment... 5-1 5.1.2 Test Report ... 5-1 5.1.3 Preventative Maintenance ... 5-1 5.1.4 Recommended Frequency... 5-2 5.2 Visual Inspection ... 5-3 5.3 Power-on Test ... 5-3 5.4 Module Performance Tests ... 5-3 5.4.1 ECG Test and Calibration... 5-3 5.4.2 Resp Test ... 5-4 5.4.3 SpO2 Test... 5-4 5.4.4 NIBP Test ... 5-5 5.4.5 Temp Test... 5-7 5.4.6 IBP Test and Calibration... 5-7 5.4.7 C.O. Test... 5-9 5.4.8 Mainstream CO2 Tests... 5-9 5.4.9 Sidestream and Microstream CO2Tests and Calibration...5-10 5.5 Nurse Call Function Test ...5-12 5.6 Analog Output Performance Test...5-13 5.7 Electric Safety Tests ...5-13 5.8 Touchscreen calibration...5-13 5.9 Recorder check...5-13 5.10 Battery Check...5-14 5.11 Factory Maintenance...5-14 5.11.1 Accessing Factory Maintenance Menu ...5-14 5.11.2 Drawing Waves ...5-15 5.11.3 Recorder ...5-15 5.11.4 Software Version...5-15 5.11.5 Monitor information recording...5-16

2

6 Corrective Action ... 6-1 6.1 Introduction ...6-1 6.2 Part Replacement ...6-1 6.3 Checking Patient Monitor Status...6-1 6.4 Checking Software Version...6-1 6.5 Checking Technical Alarms ...6-2 6.6 Troubleshooting Guide ...6-2 6.6.1 Power On/Off Failure ...6-2 6.6.2 Display Failures ...6-2 6.6.3 Alarm Lamp Failures ...6-3 6.6.4 Button and Knob Failures ...6-3 6.6.5 Sound Failures...6-4 6.6.6 Power Supply Failures ...6-4 6.6.7 Recorder Failures...6-5 6.6.8 Output Interface Failure ...6-5 6.6.9 SD Card Failure...6-6 6.6.10 Wired Network Related Problems ...6-6 6.6.11 Wi-Fi Related Problems...6-7 6.6.12 Software Upgrade Problems ...6-7 6.6.13 Technical Alarm Messages ...6-7

7 Disassembly and Repair... 7-1 7.1 Tools Required ...7-1 7.2 Preparations for Disassembly...7-1 7.3 Disassembling the Main Unit ...7-2 7.3.1 Separating the Front and Rear Half of the Monitor...7-2 7.3.2 Removing the Parameter Connector Panel Assembly ...7-3 7.3.3 Disassembling the Parameter Module Assembly ...7-3 7.3.4 Removing the Battery Compartment Assembly ...7-6 7.3.5 Removing the Power Management and Interface Board ...7-6 7.3.6 Removing the Recorder (Optional) ...7-7 7.3.7 Checking Waterproof Strips before Reassembling...7-7 7.4 Disassembling the Front Housing Assembly...7-8 7.4.1 Removing Touchscreen Control Board (Optional) ...7-8 7.4.2 Removing Antenna (Optional)...7-9 7.4.3 Removing SD Card (Optional) ...7-9 7.4.4 Removing the Main Board... 7-10 7.4.5 Removing the Touchscreen (Optional) ... 7-11 7.4.6 Disassembling the Screen ... 7-11 7.4.7 Removing the Keypad... 7-13 7.4.8 Removing the Encoder ... 7-13 7.4.9 Removing the Alarm Lamp Board ... 7-14 7.4.10 Removing the ON/OFF Key Board... 7-14 7.5 Disassembling the Battery Compartment Assembly ... 7-14 7.5.1 Removing the Power Board ... 7-14 7.5.2 Removing the Battery Interface Board Assembly ... 7-15 3

7.6 Disassembling the Parameter Module Assembly...7-15 7.6.1 Removing the Mindray M02C CO2 Module (Optional)...7-15 7.6.2 Removing the Mainstream CO2 Module (Optional) ...7-16 7.6.3 Removing the Microstream CO2 module (Optional)...7-16 7.6.4 Removing the C.O. Module (Optional) ...7-16 7.6.5 Removing the SpO2 Board...7-17 7.6.6 Removing the Multi-parameter Module...7-17 7.6.7 Removing the Pump and Valve ...7-17 7.7 Removing the Parameter Connector Assembly...7-18 7.7.1 Removing the Mainstream CO2 Signal Cable (Optional)...7-18 7.7.2 Removing the Microstream CO2 Connector Assembly (Optional)...7-18 7.7.3 Removing the Watertrap Base Assembly (Optional) ...7-19 7.7.4 Removing the Cables from the Parameter Connector Assembly ...7-19 7.7.5 Removing the Recorder ...7-20

8 Parts... 8-1 8.1 Introduction... 8-1 8.2 iMEC8... 8-2 8.2.1 Main unit... 8-2 8.2.2 Front Housing Assembly (Nakescreen)... 8-3 8.2.3 Front Housing Assembly (Touchscreen) ... 8-5 8.2.4 Rear Housing (Network/VGA/USB/Analog Input & Output)... 8-7 8.2.5 Rear Housing Assembly ... 8-8 8.2.6 Battery Compartment Assembly ... 8-9 8.2.7 Parameter module assembly...8-10 8.2.8 Parameter connector panel assembly ...8-12 8.2.9 Mindray Sidestream CO2 Module Kit ...8-13 8.2.10 Ordion Microstream CO2 Module Kit ...8-14 8.2.11 Capnostat Mainstream CO2 module kit ...8-15 8.2.12 TR6F Recorder Kit ...8-16 8.2.13 Battery charge board assembly (12 inch)...8-16 8.3 iMEC10 ...8-17 8.3.1 Main unit...8-17 8.3.2 Front Panel Assembly (10 Inch/touchscreen/Wi-Fi+ 1G SD card)...8-18 8.3.3 Fujitsu Touchscreen Kit (10 Inch LCD) ...8-19 8.3.4 Front Housing Assembly (10 Inch) ...8-20 8.3.5 Tianma LCD display kit (10 inch) ...8-22 8.3.6 Rear Housing Assembly ...8-23 8.3.7 Rear Housing Assembly ...8-25 8.3.8 Battery Compartment Assembly ...8-26 8.3.9 Parameter Module Assembly ...8-27 8.3.10 Parameter Connector Assembly...8-27 8.3.11 Mindray Sidestream CO2 Module Kit...8-27 8.3.12 Oridion Microstream CO2 Module Kit ...8-27 8.3.13 Capnostat Mainstream CO2 Module Kit ...8-27 8.3.14 TR6F Recorder Kit ...8-27 4

8.3.15 Battery Interface Board Assembly... 8-27 8.4 iMEC12... 8-27 8.4.1 Main Unit ... 8-27 8.4.2 Front Panel Assembly (12 Inch/touchscreen/Wi-Fi+ 1G SD card) ... 8-28 8.4.3 Fujitsu touchscreen kit (12 Inch) ... 8-29 8.4.4 Front Housing Assembly (12 Inch)... 8-30 8.4.5 Tianma LCD Display Kit (12 Inch)... 8-32 8.4.6 Rear Housing Assembly... 8-32 8.4.7 Rear Housing Subassembly... 8-32 8.4.8 Battery Compartment Assembly... 8-33 8.4.9 Parameter Module Assembly ... 8-33 8.4.10 Parameter Connector Assembly ... 8-33 8.4.11 Mindray Sidestream CO2 Module Kit... 8-33 8.4.12 Oridion Microstream CO2 Module Kit ... 8-33 8.4.13 Capnostat Mainstream CO2 Module Kit... 8-33 8.4.14 TR6F Recorder Kit ... 8-33 8.4.15 Battery Interface Board Assembly... 8-33 8.5 Other Maintainable Parts... 8-34

A Electrical Safety Inspection ... A-1 A.1 Power Cord Plug... A-1 A.2 Device Enclosure and Accessories ... A-1 A.3 Device Labeling ... A-2 A.4 Protective Earth Resistance... A-2 A.5 Earth Leakage Test... A-3 A.6 Patient Leakage Current ... A-4 A.7 Mains on Applied Part Leakage ... A-6 A.8 Patient Auxiliary Current ... A-7 A.9 Scheduled Electrical Safety Inspection... A-9 A.10 Electrical Safety Inspection after Repair...A-10

5

FOR YOUR NOTES

6

1 Safety 1.1 Safety Information

DANGER z

Indicates an imminent hazard that, if not avoided, will result in death or serious injury.

WARNING z

Indicates a potential hazard or unsafe practice that, if not avoided, will result in death or serious injury.

CAUTION z

Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

NOTE z

Provides application tips or other useful information to ensure that you get the most from your product.

1-1

1.1.1 Dangers There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective sections of this manual.

1.1.2 Warnings WARNING z

All installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel.

z

There is high voltage inside the equipment. Never disassemble the equipment before it is disconnected from the AC power source or the battery.

z

When you disassemble/reassemble a parameter module, a patient leakage current test must be performed before it is used again for monitoring.

z

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.

z

Disposal of the packaging material should observe the applicable waste control regulations. and keeping it out of children’s reach.

1.1.3 Cautions CAUTION z

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.

z

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.

z

Protect the equipment from damage caused by drop, impact, strong vibration or other mechanical force during servicing.

1.1.4 Notes NOTE z

Refer to Operation Manual for detailed operation and other information.

1-2

1.2 Equipment Symbols Caution (Attention, consult

Power ON/OFF

accompanying documents) Warning: dangerous voltage

Serial number

Alternating current

Battery

AUDIO PAUSED

ALARM PAUSED

Freeze waveforms

Graphical recorder

NIBP

Menu

Equipotentiality

Video output

USB connector

Output

Output; exit

Network interface

Date of manufacture

Inserted direction

The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive. Electrostatic sensitive devices

DEFIBRILLATION-PROOF TYPE CF APPLIED PART

DEFIBRILLATION-PROOF TYPE BF APPLIED PART

1-3

FOR YOUR NOTES

1-4

2 Theory of Operation 2.1 Introduction This patient monitor is designed to monitor a fixed set of physiological parameters including ECG, respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), and carbon dioxide (CO2).

The patient monitor also: „

Provides audible and visual alarm indications in case of patient or equipment problems.

„

Enables displaying, reviewing, storing and transferring of real-time data and wave.

„

Incorporates multiple input devices such as buttons, knob, and touchscreen.

„

Enables program upgrade over the network.

„

Integrates the information of other devices, which include but are not restricted to defibrillator.

Sy Sig nch na ro l O ni ut zed pu t

Local Display Defibrillator

Centeral Station Fi Wi-

LAN

Remote Monitor

2-1

The above figure shows a system consists of the iMEC patient monitor and its peripheral devices. The iMEC patient monitor: „

Can be used for monitoring the physiological parameters, giving alarms and reviewing patient data, etc.

„

Supports recorder.

„

Supports nurse call signal, synchronization defibrillation signal, and analog output signal.

„

Supports Wi-Fi module, wired network, remote view, and communication with the HyperVisor Central Monitoring System.

„

Supports a secondary display.

„

Supports external AC power source and an internal battery.

„

Supports clinical data acquisition, which has two ways: by SD card and by USB drive. The system software should support data output function, for SD card is a built-in device.

2.2 System Connections 2.2.1 Installation Support The patient 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. Refer to the documentation delivered with the mounting hardware for instructions on assembling mounts.

CAUTION z

Use mounting brackets we supply or approve. If other compatible mounting bracket is used, be sure it can be safely used on the patient monitor.

z

The mounting bracket should be installed by our qualified service personnel, or engineers who have adequate knowledge on it.

z

If other mounting solution is used, the installation personnel and the customer should verify if it can be safely used on the patient monitor, and the customer assume the responsibility for any risk resulting from that.

2-2

2.2.2 Connectors for Peripheral Devices On the back of the patient monitor you can find all connectors for peripheral devices.

5

6

2

1 3

Figure 1

1.

4

iMEC Rear View

AC power input: used to connect an AC power source (100 to 240 VAC, 50/60 Hz).

2.

Equipotential terminal: used to connect the equipotential terminal of other equipments, eliminating potential difference between different pieces of equipment.

3.

VGA connector: used to connect a secondary display.

4.

Network connector: an RJ45 connector, used to connect an Ethernet network or a PC.

5.

Multifunctional connector: used to output analog signals and defibrillator synchronization signals.

6.

General USB connector: used to connect any USB-compatible peripheral device.

2-3

2.3 Main Unit The main unit of the patient monitor consists of two parts: „

Front housing assembly: main board, keypad board assembly (knob), display, touchscreen, alarm lamp board, power switch, and indicator board.

„

Rear housing assembly: power board (AC/DC), battery pad, interface board, recorder, speaker, multi-parameter module which includes three types of SpO2 stacking board, CO2 module, and IBP/C.O. module.

The following figure shows the main unit architecture of the patient monitor.

2-4

2.4 Front Housing Assembly Alarm lamp board Display bracket

Navigatio n knob Main board Keypad Touchscreen control board

Power on/off board

2.4.1 Main Board The main board is located at the center of the front housing assembly's LCD metal sheet. It is the heart of the patient monitor. It provides communication, display, and data storage functions, including: „

Display drive and backlight control

„

Wired and wireless network

„

Data storage (DDR, NOR flash, and SD card)

„

Printing

„

Serial ports: there are 7 serial ports, respectively for multi-parameter module, C.O./IBP module, sidestream/mainstream CO2 module, recorder, power board, and key board. The seventh serial board is for future use.

„

Connection with touchscreen control board

„

Audio drive

„

EEPROM drive

„

USB

2-5

The main board has the following interfaces to connect other PCBAs: „

Display signal interface

„

Backlight control interface

„

Keypad interface

„

Alarm lamp interface

„

Wi-Fi interface

„

SD storage card interface

„

Interface board interface (for external output, module communication, power supply and etc.)

2.4.2 Keypad and the Navigation Knob The keypad and navigation knob are located at the right side of the front housing assembly. The navigation knob can be rotated both clockwise and counterclockwise. It can also be pressed down. The navigation knob is connected with the keypad. The keypad has the following functions: „

It scans and detects the input of the six keys;

„

It integrates the power on/off hardkey;

„

It integrates the rotary encoder;

„

It connects and forwards the status of power switch and LED board to the main board; and,

„

It communicates with the main board through a serial port.

The following figure shows the connection of keypad:

2-6

2.4.3 Power On/Off and LED Indicator Board The power on/off and LED indicator board is connected with the keypad. It controls the patient monitor's power switch. It has 3 groups of indicators which are used to indicate the status of AC mains, battery, as well as the monitor's power on/off status.

2.4.4 Alarm Lamp Board The alarm lamp board is located at the top of the 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.

2.4.5 Display iMEC8, iMEC10 and iMEC12 respectively support 8-inch, 10-inch, and 12-inch LCDs. The display connects the main board through a display signal cable and a backlight cable. The interface cables for the three types of patient monitors are different and cannot be mixed. The reliability of display signal cable is relatively poor. If display problem occurs, consider first to replace the display signal cable.

2.4.6 Touchscreen and Touchscreen Control Board The fully configured iMEC patient monitor supports touchscreen. The touchscreen can be controlled by touch and can be calibrated. The touchscreen is connected with the touchscreen control board and the main board. The touchscreen control board drives the touchscreen and implements communication with the patient monitor. The touchscreen control board communicates with the main board via an I2C interface and connects the touchscreen via FPC.

2.5 Rear Housing Assembly

2-7