MINDRAY
iPM 12, 10, 8 Service Manual Rev 4.0 Sept 2013
Service Manual
132 Pages
Preview
Page 1
iPM 12/iPM 10/iPM 8
Patient Monitor
Service Manual
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, 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.
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:
September 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: MPM
multi-parameter module
SMR
satellite module rack
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
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 CAUTION ...1-2 1.1.4 NOTE...1-2 1.2 Equipment Symbols ...1-3
2 Theory of Operation ... 2-1 2.1 The Basics ...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 ...2-5 2.4 Front Housing Assembly...2-6 2.4.1 Main Board ...2-6 2.4.2 Keypad ...2-6 2.4.3 Alarm Lamp Board...2-7 2.4.4 Touchscreen and Touchscreen Control Board ...2-7 2.4.5 Wi-Fi Module...2-7 2.5 Rear Housing Assembly ...2-7 2.5.1 AC/DC Power Board ...2-8 2.5.2 Power Management Board ...2-8 2.5.3 Interface Board ...2-8 2.5.4 Battery Interface Board...2-8 2.5.5 Recorder ...2-8 2.5.6 Multi-parameter Board ...2-8 2.5.7 SpO2 Board ...2-9 2.5.8 Parameter Connector Board ...2-9 2.6 Modules ...2-9 2.6.1 Module Converter...2-9 2.6.2 Converter ... 2-10 2.6.3 IBP + C.O. Module ... 2-10 2.6.4 CO2 Module ... 2-10 2.6.5 AG Module... 2-10
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 1
3.2.3 Monitor Installation ... 3-3 3.2.4 Preparation for Power on... 3-3
4 Hardware and Software Upgrade... 4-1 4.1 Hardware Upgrade ... 4-1 4.1.1 Upgrade Package ... 4-1 4.1.2 Hardware Upgrade Method... 4-2 4.2 Software Upgrade... 4-4 4.2.1 Installing Mindray Patient Monitor Software Upgrade Tool ... 4-4 4.2.2 Software Upgrade Procedure... 4-6
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 Tests 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 CO2 Tests...5-10 5.4.10 AG Tests and Calibration...5-12 5.5 Nurse Call Reply Performance Test ...5-15 5.6 Analog Output Performance Test...5-15 5.7 Electric Safety Tests ...5-15 5.8 Touchscreen Calibration ...5-16 5.9 Recorder Check...5-16 5.10 Battery Check...5-16 5.11 Factory Maintenance...5-17 5.11.1 Accessing Factory Maintenance Menu ...5-17 5.11.2 Drawing Waves ...5-17 5.11.3 Recorder ...5-17 5.11.4 Software version...5-18 5.11.5 Monitor information recording...5-19
6 Troubleshooting ... 6-1 6.1 Introduction... 6-1 6.2 Part Replacement... 6-1 2
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 Battery Failures ...6-4 6.6.7 Recorder Failures...6-5 6.6.8 Output Interface Failure ...6-5 6.6.9 Data Storage Failure...6-6 6.6.10 Wired Network Related Problems ...6-6 6.6.11 Wi-Fi Related Problems...6-7 6.6.12 Module Failures...6-7 6.6.13 Software Upgrade Problems ...6-8 6.6.14 Technical Alarm Messages ...6-8
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 Disassembling Parameter Modules...7-3 7.3.3 Removing the Parameter Connector Panel Assembly ...7-3 7.3.4 Removing the SpO2 Board and Parameter Board ...7-3 7.3.5 Removing Pump and Valve ...7-4 7.3.6 Removing the Recorder (Optional) ...7-4 7.3.7 Removing Battery Interface Board and Power Board (iPM 8/iPM 10)...7-5 7.3.8 Removing the Battery Interface Board and Power Board (iPM 12)...7-6 7.3.9 Removing the Power Management Board ...7-7 7.3.10 Removing the Interface Board (iPM 8)...7-8 7.3.11 Removing the Interface Board (iPM 10/iPM 12) ...7-8 7.4 Disassembling the Front Housing Assembly...7-8 7.4.1 Removing Touchscreen Control Board (Optional) ...7-9 7.4.2 Removing the Wi-Fi Module (Optional) ...7-9 7.4.3 Removing SD Card (Optional) ... 7-10 7.4.4 Removing the Main Control 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... 7-11 7.4.8 Removing the Encoder ... 7-11 7.4.9 Removing the Alarm Lamp Board ... 7-12 7.5 Disassembling Modules... 7-12 7.5.1 Removing the External Converter Board ... 7-12 3
7.5.2 Separating the Front and Rear Housing of Modules ...7-12 7.5.3 Removing the External Module Interface Board...7-13 7.5.4 Removing M03B Module ...7-13 7.5.5 Removing Sidestream CO2 Module...7-14 7.5.6 Removing Microstream CO2 Module...7-14 7.5.7 Removing AG Module...7-15
8 Parts... 8-1 8.1 Introduction... 8-1 8.2 iPM 8 ... 8-2 8.2.1 Main Unit ... 8-2 8.2.2 Front Housing Subassembly (Touchscreen) ... 8-3 8.2.3 Front Housing Assembly (Nakescreen)... 8-5 8.2.4 Rear Housing Assembly ... 8-7 8.2.5 Multi-parameter Assembly ... 8-8 8.2.6 Battery Compartment Assembly ...8-10 8.2.7 NIBP Pump and Valve Kit ...8-11 8.2.8 IBP_C.O. Module Assembly ...8-12 8.2.9 IBP_C.O._Sidestream CO2 Module Assembly...8-13 8.2.10 IBP_C.O._Microstream CO2 Module Assembly ...8-15 8.2.11 IBP_C.O._Mainstream CO2 Module Assembly...8-17 8.2.12 IBP_C.O._AG Module Assembly ...8-18 8.3 iPM 10...8-20 8.3.1 Main Unit ...8-20 8.3.2 Front Housing Subassembly (Touchscreen) ...8-21 8.3.3 Front Housing Assembly (Nakescreen)...8-23 8.3.4 Rear Housing Assembly ...8-25 8.3.5 Battery Compartment Assembly ...8-26 8.3.6 Multi-parameter Assembly ...8-27 8.3.7 NIBP Pump and Valve Kit ...8-27 8.3.8 IBP_C.O. Module Assembly ...8-27 8.3.9 IBP_C.O._Sidestream CO2 Module Assembly...8-27 8.3.10 IBP_C.O._Microstream CO2 Module Assembly ...8-27 8.3.11 IBP_C.O._Mainstream CO2 Module Assembly...8-27 8.3.12 IBP_C.O._AG Module Assembly ...8-27 8.4 iPM 12...8-28 8.4.1 Main Unit ...8-28 8.4.2 Front Housing Subassembly (Touchscreen) ...8-29 8.4.3 Front Housing Assembly (Nakescreen)...8-31 8.4.4 Rear Housing Assembly ...8-32 8.4.5 Battery Compartment Assembly ...8-34 8.4.6 Multi-parameter Assembly ...8-34 8.4.7 NIBP Pump and Valve Kit ...8-34 8.4.8 IBP_C.O. Module Assembly ...8-35 8.4.9 IBP_C.O._Sidestream CO2 Module Assembly...8-35 8.4.10 IBP_C.O._Microstream CO2 Module Assembly ...8-35 4
8.4.11 IBP_C.O._Mainstream CO2 Module Assembly ... 8-35 8.4.12 IBP_C.O._AG Module Assembly... 8-35
A Electrical Safety Inspection ... A-1 A.1 Power Cord Plug... A-1 A.2 Device Enclosure and Accessories ... A-1 A.2.1 Visual Inspection... A-1 A.2.2 Contextual Inspection ... 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-8 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 CAUTION
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 NOTE NOTE z
Refer to Operator’s Manual for detailed operation and other information.
1-2
1.2 Equipment Symbols Attention: Consult accompanying
Power ON/OFF
documents (this manual). Direct Current (DC)
Serial Number
Alternating current（AC）
Battery
Silencing Alarms
Pausing Alarms
Freeze/unfreeze waveforms
Record
NIBP
Enter the main menu
Equipotential Grounding Terminal
VGA output
USB connector
Multifunctional output
Gas outlet
Network interface
Manufacture date
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. ESD warning symbol for electrostatic sensitive devices. Type CF applied part. The unit displaying this symbol contains an F-type isolated (floating) patient part providing a high degree of protection against shock, and is suitable for use during defibrillation. 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. Type BF applied part. Defibrillator-proof protection against electric shock.
1-3
FOR YOUR NOTES
1-4
2 Theory of Operation 2.1 The Basics 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.), carbon dioxide (CO2), and anesthetic gas (AG).
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.
Si a gn ut lO
Defibrillation
Main unit
CMS
t pu
module
Local Display
LAN
iPM-T nal Sig g o ut al An Outp
W i-
Fi
Remote Monitor IABP
2-1
Printer
The above figure shows a system consists of the iPM patient monitor and its peripheral devices. The iPM 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 AC power source and battery power source (iPM 8 patient monitors additionally supports DC power source).
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. Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.
2-2
2.2.2 Connectors for Peripheral Devices On the back of the patient monitor you can find all connectors for peripheral devices.
iPM 10/12 Rear View
1.
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.
Parameter Module slot:
used to connect the parameter module.
4.
General USB Connector:
used to connect any USB-compatible peripheral device.
5.
Multifunctional connector:
used to output analog signals and defibrillator synchronization signals.
6.
Network Connector:
an RJ45 connector, used to connect an Ethernet network or a PC.
7.
VGA Connector:
used to connect a secondary display.
2-3
iPM 8 Rear View
1.
Equipotential terminal:
used to connect the equipotential terminal of other equipments, eliminating
potential difference between different pieces of equipment. 2.
AC power input:
used to connect an AC power source (100 to 240 VAC, 50/60 Hz).
3.
Parameter Module slot:
used to connect the parameter module.
4.
Multifunctional connector:
used to output analog signals and defibrillator synchronization signals.
5.
DC power input
6.
General USB Connector:
used to connect any USB-compatible peripheral device.
7.
Network Connector:
an RJ45 connector, used to connect an Ethernet network or a PC.
8.
VGA Connector:
used to connect a secondary display.
2-4
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), power management board, battery pad, interface board, recorder, speaker, and multi-parameter module which includes three types of SpO2 stacking board.
The following figure shows the main unit architecture of the patient monitor.
Interface Board
Speaker
Power Board Power Management Board
Multi-parameter Board
Battery Interface Board Recorder SpO2 Board
Alarm Lamp Board
Main Board
Display
Keypad Board Antenna Touchscr een
Touchscreen Control Board
Wi-Fi
2-5
Parameter Connector Panel
2.4 Front Housing Assembly Screws fixing the front and rear housing
Alarm lamp board
Main board
Wi-Fi module
Keypad Touchscreen control board
Lock hatch
2.4.1 Main Board The main board is the control center of the system. It provides communication, display, and data storage functions, including:
Display drive and backlight control
Wired and wireless network
Data Storage
Printing
Serial port communication
Connection with touchscreen control board
Audio drive
EEPROM drive
USB drive
2.4.2 Keypad The keypad scans and detects the input of keys and knobs, integrates the power on/off key, and connects AC and battery indicators.
2-6
2.4.3 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.
2.4.4 Touchscreen and Touchscreen Control Board The touchscreen control board drives the touchscreen and implements communication with the patient monitor.
2.4.5 Wi-Fi Module The Wi-Fi module enables the patient monitor to connect to 802.11 g/n wireless network.
2.5 Rear Housing Assembly
Pump and valve assembly Multi-parameter assembly
Recorder assembly Parameter panel assembly
Interface Board
Main bracket assembly
Power management board
The rear housing assembly consists of the parameter panel assembly, multi-parameter assembly, pump and valve assembly, recorder assembly, main bracket assembly (including the battery compartment and battery interface board), power management board, and interface board.
2-7