1.1 Safety Information .............................................................................................................................................................................................. 1-1
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
2.4.4 Touchscreen and Touchscreen Control Board ........................................................................................................................... 2-7
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
3.2.4 Preparation for Power on .................................................................................................................................................................. 3-3
4 Hardware and Software Upgrade............................................................................................................................... 4-1
5.1.1 Test Equipment ..................................................................................................................................................................................... 5-1
5.1.2 Test Report ............................................................................................................................................................................................. 5-1
5.1.4 Recommended Frequency ............................................................................................................................................................... 5-2
5.3 Power-on Test ....................................................................................................................................................................................................... 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
5.11.4 Software version .............................................................................................................................................................................. 5-18
5.11.5 Monitor information recording .................................................................................................................................................. 5-19
6.2 Part Replacement ................................................................................................................................................................................................ 6-1
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6.3 Checking Patient Monitor Status ................................................................................................................................................................... 6-1
6.4 Checking Software Version .............................................................................................................................................................................. 6-1
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
7.3.3 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 5/iPM 6/iPM 8/iPM 10) ..................................................... 7-5
7.3.8 Removing the Battery Interface Board and Power Board (iPM 7/iPM 12) ....................................................................... 7-6
7.3.9 Removing the Power Management Board ................................................................................................................................. 7-7
7.3.10 Removing the Interface Board (iPM 5/iPM 8) .......................................................................................................................... 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
7.4.4 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
7.5.1 Removing the External Converter Board ................................................................................................................................. 7-12
3
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7.5.2 Separating the Front and Rear Housing of Modules ............................................................................................................ 7-12
7.5.3 Removing the External Module Interface Board .................................................................................................................... 7-13
7.5.5 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
8.2.1 Main Unit ................................................................................................................................................................................................ 8-2
8.2.2 Front Housing Subassembly (Touchscreen) .............................................................................................................................. 8-3
8.2.3 Front Housing Assembly (Nakescreen) ........................................................................................................................................ 8-5
8.3.1 Main Unit .............................................................................................................................................................................................. 8-18
8.3.2 Front Housing Subassembly (Touchscreen) ............................................................................................................................ 8-19
8.3.3 Front Housing Assembly (Nakescreen) ...................................................................................................................................... 8-21
8.4.1 Main Unit .............................................................................................................................................................................................. 8-27
8.4.2 Front Housing Subassembly (Touchscreen) ............................................................................................................................ 8-28
8.4.3 Front Housing Assembly (Nakescreen) ...................................................................................................................................... 8-30
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.10 Electrical Safety Inspection after Repair ................................................................................................................................................ A-10
5
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FOR YOUR NOTES
6
Page 11
1 Safety
1.1 Safety Information
DANGER
Indicates an imminent hazard that, if not avoided, will result in death or serious injury.
WARNING
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.
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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
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.
1.1.3 CAUTION
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.
1.1.4 NOTE
NOTE
Refer to Operator’s Manual for detailed operation and other information.
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1.2 Equipment Symbols
Caution, consult accompanying documents
Power ON/OFF (for a part of the
equipment)
Alternating current
AUDIO PAUSED
Freeze/unfreeze waveforms
NIBP start/stop key
Alternating/Direct current
Equipotentiality
USB connector
Gas outlet
Battery indicator
ALARM PAUSED
Graphical recorder
Main menu
Inserted direction
Direct current
VGA output
Network connector
Input/output
DATE OF MANUAFACTURE
AUTHORISED REPRESENTATIVE IN
THE EUROPEAN COMMUNITY
DEFIBRILLATION-PROOF TYPE CF
APPLIED PART
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.
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.
NOTE
Some symbols may not appear on your equipment.
Serial number
Electrostatic sensitive devices
DEFIBRILLATION-PROOF TYPE BF
APPLIED PART
1-3
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FOR YOUR NOTES
1-4
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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), SpO
output (C.O.), carbon dioxide (CO
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.
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/iPM 5 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
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.
The mounting bracket should be installed by our qualified service personnel, or engineers who have
adequate knowledge on it.
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.
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2.2.2 Connectors for Peripheral Devices
On the back of the patient monitor you can find all connectors for peripheral devices.
iPM 6/7/10/12 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.
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iPM 5/8 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.
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2.3 Main Unit
The main unit of the patient monitor consists of two parts:
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 SpO
The following figure shows the main unit architecture of the patient monitor.
stacking board.
2
Speaker
Power Board
Battery
Interface Board
Recorder
Alarm Lamp
Board
Keypad
Board
Interface Board
Power Management Board
Main Board
Multi-parameter Board
SpO2Board
Display
Parameter
Connector
Panel
Antenna
Touchscr
een
Touchscreen
Control
Board
Wi-Fi
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2.4 Front Housing Assembly
Alarm lamp board
Wi-Fi module
Touchscreen
control board
Screws fixing the front and rear housing
Main board
Keypad
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.
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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
Multi-parameter
assembly
Parameter panel
assembly
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.
Main bracket assembly
Power management board
assembly
Recorder assembly
Interface Board
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2.5.1 AC/DC Power Board
The AC/DC power board transforms the input AC into DC power, which is the power source for all voltages in the
patient monitor.
2.5.2 Power Management Board
The power management board mainly performs DC/DC conversion, power management, and transmission of external
connector signals:
DC/DC conversion: outputs 12 V and 5 V DC power
Power on/off control
Charge/Discharge control
Signal transmission
2.5.3 Interface Board
The interface board supports the USB ports, network ports, multifunctional ports. and VGA ports.
2.5.4 Battery Interface Board
The battery interface board introduces the battery power to the internal system.
2.5.5 Recorder
The recorder receives data from the main board and sends them to the thermal printhead for printing.
2.5.6 Multi-parameter Board
The multi-parameter board provides the following functions:
Supports 2-channel 3-/5-lead ECG monitoring (and 12-lead in future), and I/II lead Resp monitoring
Provides power for and communicates with Mindray/Nellcor/Masimo SpO
Supports 2-channel Temp monitoring
Supports 2-channel IBP monitoring
Supports NIBP monitoring
Processes all algorithms and communicates with the main board via UART
Realizes analog output (four channels, one for ECG, two for IBP, and the other for Defib sync output)
Isolates the parameter modules from the earth
Isolates ECG from other parameters
2-8
board
2
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2.5.7 SpO
The multi-parameter module supports the independently developed Mindray SpO2 board, which provides SpO2
measurement as good as other boards but with smaller size and lower consumption. It is also compatible with Nellcor
NELL-1 SpO
SpO
Board
2
board and Masimo MS-2013 SpO2 board.
2
board is used to collect SpO2 signals transmitted by the multi-parameter module and process SpO2 algorithms.
2
2.5.8 Parameter Connector Board
The parameter connector board transmits the ECG signal, Temp signal, SpO2 signal, and IBP signals collected through
cables to the multi-parameter board.
2.6 Modules
The patient monitor can carry multiple parameter modules, which include IBP/C.O., CO2, and AG modules. The
detailed module configuration is listed below:
IBP module
CO
IBP + C.O. Module
IBP + C.O. + CO
IBP + C.O. + AG (w O
The module converter performs signal conversion function.
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2.6.2 Converter
The converter performs the following functions:
Converting 12 V to 5 V DC power
Converting 232 level to TTL level
Detecting and identifying the modules
2.6.3 IBP + C.O. Module
The IBP/C.O. module supports C.O. and 2-channel measurement of IBP. The module consists of an amplification circuit,
AD converter, CPU circuit and power isolation circuit.
2.6.4 CO
The patient monitor supports the following CO2 modules:
Module
2
M02C Sidestream module
Capnostat Mainstream CO
Ordion Microstream CO
module
2
module
2
2.6.5 AG Module
There are two configurations for the 2.5G Artema AG module: with O2 and without O2.
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3 Unpacking and 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 shall also be checked.
Notify the supplier if provided components are not correct as compared to the packing list.
In case of damage during transportation, keep the packing material and notify the supplier immediately.
Keep the packing material till new equipment is accepted.
The following pictures show the patient monitor and accessory packing.
Accessories
Operator's
Manual and
Packing List
Main Unit
Main unit packing
Accessory packing
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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. Check that required power sockets are available.
3. Check that a network connector is available if the patient monitor needs to be connected to network.
Environmental Requirements
To avoid explosion hazard, do not use the equipment in the presence of flammable anesthetics, vapors or liquids. The
environment where the patient monitor 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 (iPM 5/8)
Item Temperature (°C) Relative humidity (noncondensing) Altitude (kPa)
Operating environment 0 to 40 15% to 95% 57.0 to 107.4
Storage environment -30 to 70 10% to 95% 16.0 to 107.4
Main Unit (iPM 6/7/10/12)
Item Temperature (°C) Relative humidity (noncondensing) Altitude (kPa)
Operating environment 0 to 40 15% to 95% 57.0 to 107.4
Storage environment -20 to 60 10% to 95% 16.0 to 107.4
Mainstream CO2 module
Item Temperature (°C) Relative humidity (noncondensing) Altitude (kPa)
Operating environment 0 to 40 15% to 90% 57.0 to 107.4
Storage environment -20 to 60 10% to 90% 53.3 to 107.4
Sidestream CO2 module
Item Temperature (°C) Relative humidity (noncondensing) Altitude (kPa)
Operating environment 5 to 40 15% to 95% 57.3 to 105.3
Storage environment -20 to 60 10% to 95% 57.3 to 105.3
Microstream CO2 module
Item Temperature (°C) Relative humidity (noncondensing) Altitude (kPa)
Operating environment 0 to 40 15% to 95% 57.3 to 105.3
Storage environment -20 to 60 10% to 95% 57.3 to 105.3
NOTE
The environmental specifications of unspecified parameters are the same as those of iPM 6/7/10/12 main
unit.
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3.2.2 Electrical Requirements
Check cables and power cords. Make sure that:
1. Check that the system cables, power cords, and power plugs are not damaged, and pins are not loose. In case of
any damage, remove it from use.
2. The insulation of patient cables and leadwires is not damaged, and connectors are not loose.
WARNING
Only power sockets with protective grounding can be used.
1. Find the installation program and double click it to start installation.
2. Select [英语].
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3. Click [确定] and the following screen is displayed. Click [Next] to go to the next step.
4. Enter User Name, Company name, and Serial Number "26582640". Then click [Next].
5. Specify the destination folder for installing this program. Then select [Next].
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6. Select Program Folder. Then select [Next].
7. Click [Finish] to complete installation.
4.2.2 Software Upgrade Procedure
Before software upgrade, select [Main Menu→] [Maintenance >>→] [Factory Maintenance >>→] enter the
required password [Software Version] to check the current software version, as described in 5.11.4 Software
version.
1. Connect the monitor to be upgraded and a PC running the upgrade tool to the same network, or directly
connect the monitor and the PC via a network cable (a crossover network cable is recommended).
2. Set the IP address of the PC to "77.77.1.XX" and subnet mask to "255.255.255.0".
→
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3. Run Mindray Patient Monitor Software Upgrade Tool on the PC and set Machine to [iPM 8/10/12].
4. On the Mindray Patient Monitor Software Upgrade Tool screen, select [Select Package] and then the packages
you want to upgrade. Then select [Start].
5. Turn on the patient monitor to be upgrade. Press and hold "Silence" and "Main Menu" buttons for 2 to 3 seconds,
the patient monitor enters upgrade mode and starts software upgrade automatically, and corresponding prompt
messages are displayed on both the patient monitor and PC.
When software upgrade is finished, restart the patient monitor and check if the software is correctly upgrade.
For details of software upgrade, please refer to help and instructions for use of Mindray Patient Monitor Software
Upgrade Tool.
CAUTION
Disconnect the equipment from the patient and make sure the important data are saved before upgrade.
Do not shut down or power off the equipment when upgrading the system software. Otherwise, it may
cause the equipment to break down.
Software upgrade should be performed by qualified service personnel only.
Crossover network cable is recommended when a PC is connected for software upgrade.
NOTE
Make sure the version of the upgrade package is what you desired. To obtain the latest upgrade package,
please contact Mindray Customer Service Department.
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FOR YOUR NOTES
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5 Testing and Maintenance
5.1 Introduction
To ensure the patient monitor always functions normally, qualified service personnel should perform regular
inspection, maintenance and test. This chapter provides a checklist of the testing procedures for the patient monitor
with recommended test equipments and frequency. The service personnel should perform the testing and
maintenance procedures as required and use appropriate test equipments.
The testing procedures provided in this chapter are intended to verify that the patient monitor meets the
performance specifications. If the patient monitor 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 Customer Service
Department.
CAUTION
All tests should be performed by qualified service personnel only.
Care should be taken to change the settings in [User Maintenance] 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 applicable.
5.1.1 Test Equipment
See the following sections.
5.1.2 Test Report
Upon the completion of the tests, the table of preventative maintenance test reports and the table of maintenance
test reports in this chapter should be kept properly.
5.1.3 Preventative Maintenance
Below are preventative maintenance tests which need to be performed on the monitor. The recommended
frequency of preventative maintenance is at least once per year. See the following sections for detailed maintenance
procedures.
Visual inspection
NIBP test
CO
AG test and calibration
test and calibration
2
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5.1.4 Recommended Frequency
Check/Maintenance Item Frequency
Visual inspection 1. When first installed or reinstalled.
Power- on test
1. When first installed or reinstalled.
2. Following any repairs or replacement of any main unit parts.
ECG test
Performance Test
Module calibration
Resp performance test
SpO2 test
Pressure check
NIBP test
Leakage test
TEMP test
Performance test
IBP test
Pressure calibration
C.O. test
Mainstream CO2 test
Leakage test
Sidestream and
Microstream CO
tests
2
Performance test
Calibration
Leakage test
AG test
Performance test
Calibration
Nurse call function test
Analog output performance test
1. If the user suspects that the measurement is incorrect.
2. Following any repairs or replacement of relevant module.
3. At least once every two years.
Note: At least once a year is recommended for NIBP, CO
, and AG.
2
If the user suspects that the nurse call or analog output does not work
well.
1. Following any repair or replacement.
2. After the monitor drops.
3. At least once every two years.
1. When the touchscreen appears abnormal.
2. After the touchscreen is replaced.
Electric Safety Tests
Touchscreen calibration
Refer to A Electrical
Safety Inspection.
Recorder check Following any repair or replacement of the recorder.
Battery check
Functionality test
1. When first installed.
2. Whenever a battery is replaced.
Performance test Once every six months or if the battery run time reduced significantly.
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5.2 Visual Inspection
Inspect the equipment for obvious signs of damage. The test is passed if the equipment has no obvious signs of
damage. Following these guidelines when inspecting the equipment:
Carefully inspect the case, display screen, buttons, and knob for obvious signs of damage.
Inspect the power cord, wall mount, and accessories 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.
5.3 Power-on Test
This test is to verify that the patient monitor can power up correctly. The test is passed if the patient monitor starts up
by following this procedure:
1. Insert the battery in the battery compartment and connect the patient monitor to the AC mains. The AC mains
LED and battery LED light.
2. Press the power on/off switch to switch on the patient monitor.
The monitor performs self-test as soon as the monitor is powered on. During the self-test, the alarm lamp turns yellow
and red, and then turns off; the monitor gives a beep. This indicates that the visual and audible alarm indicators
operate properly.
5.4 Module Performance Tests
5.4.1 ECG Tests and Calibration
ECG Performance Test
Tool required:
Fluke Medsim 300B patient simulator recommended
1. Connect the patient simulator with the ECG connector using an ECG cable.
2. Set the patient simulator as follows: ECG sinus shythm, HR = 80 bpm with the amplitude as 1 mV.
3. Check the ECG waves are displayed correctly without noise and the displayed HR value is within 80 ± 1 bpm.
4. Disconnect each of the leads in turn and observe the corresponding lead off message displayed on the screen.
5. Set the simulator outputs paced signals and set [Paced] to [Yes] on the monitor. Check the pace pulse marks on
the monitor screen.
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ECG Calibration
Tool required:
Vernier caliper
1. Select the ECG parameter window or waveform area and set [Filter] to [Diagnostic].
2. Select [Main Menu→] [Maintenance >>].
3. Select [Calibrate ECG]. A square wave appears on the screen and the message [ECG calibrating] is displayed.
4. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%.
5. After completing the calibration, select [Stop Calibrating ECG].
You can print out the square wave and wave scale and then measure the difference between them if necessary.
5.4.2 Resp Test
Tool required:
Fluke Medsim 300B patient simulator recommended
1. Connect the patient simulator to the module using a non ESU-proof cable and set lead II as the respiration lead.
2. Configure the simulator as follows: lead II as the respiration lead, base impedance line as 1500 Ω, data impedance
as 0.5 Ω, and respiration rate as 40 rpm.
3. Check the Resp wave is displayed without any distortion and the displayed Resp value is within 40 ± 2 rpm.
5.4.3 SpO
Tool required:
None
1. Connect SpO
2. Apply the SpO2 sensor to your ring finger (assume that you stay healthy).
3. Check the Pleth wave and PR reading on the screen and make sure that the displayed SpO2 is within 95% and
Test
2
[SpO2].
100%.
sensor to the SpO2 connector of the monitor. Set [Patient Cat.] to [Adu] and [PR Source] to
2
4. Remove the SpO
sensor from your finger and make sure that an alarm of SpO2 Sensor Off is triggered.
2
NOTE
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor. However, it can be
used to demonstrate that a particular pulse oximeter monitor reproduces a calibration curve that has been
independently demonstrated to fulfill a particular accuracy specification.
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5.4.4 NIBP Test
NIBP Leakage Test
NOTE
Perform NIBP leakage test before any other NIBP concerned test.
Tools required:
NIBP cuff for adult patient
Tubing
Cylinder
Follow this procedure to perform the leakage test:
1. Set [Patient Cat.] to [Adu].
2. Connect the NIBP cuff to the NIBP connector on the monitor.
3. Apply the cuff to the cylinder as shown below.
Monitor
Connector for NIBP
cuff
4. Select [Main Menu→] [Maintenance >>→] [NIBP Leakage Test]. The message [Leakage Testing…] is
displayed in the NIBP parameter area.
5. The cuff automatically deflates after 20 s, which means NIBP leakage test is completed.
6. 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 leakage. In this case, check if all
connections are good and the cuff and tubing have no leakage. Perform the test again after making sure all
connections are good and the cuff and tubing have no leakage.
You can either 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 balloon pump. Then, wait for 5 seconds to let the
measured values becoming stable.
Air tubing
Cylinder
Cuff
3. Record the current pressure value, and meanwhile use a time counter to count the time. Then, record the
pressure value after 60 s.
4. Compare the two pressure values and make sure the difference should not be greater than 6 mmHg.
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NIBP Accuracy Test
Tool required:
T-shape connector
Appropriate tubing
Balloon pump
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 equipments as shown below.
Monitor
Connector for NIBP
cuff
Balloon pump
2. Before inflation, check that the reading of the manometer is 0. If not, turn off the balloon pump to let the whole
airway open to the atmosphere. Turn on the balloon pump 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 balloon pump. 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.
Appropriate tubing
Standard
sphygmomanome
ter
Rigid Vessel
7. Raise the pressure in the rigid vessel to 200 mmHg with the balloon pump. 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 balloon pump and the reference manometer to perform the
test.
You can use an appropriate cylinder and a cuff instead of the rigid vessel.
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5.4.5 Temp Test
Tool required:
Resistance box (with accuracy above 0.1 Ω)
1. Connect the two pins of any Temp connector in the monitor to the two ends of the resistance box using 2 wires.
2. Set the resistance box to 1354.9 Ω (corresponding temperature is 37 °C).
3. Verify each Temp channel of the monitor and make sure that the displayed value is within 37 ± 0.1°C.
4. Repeat steps 1 to 3 and verify another temperature channel.
5.4.6 IBP Test and Calibration
IBP Performance Test
Tools required:
Medsim300B patient simulator, or MPS450, or equivalent equipments
IBP adapter cable for test (P/N 009-002199-00 for Medsim 300B, P/N 009-002198-00, for MPS450)
1. Connect the patient simulator through the monitor's IBP connector.
2. Make the patient simulator outputs 0 mmHg to an IBP channel.
3. Select IBP Zero in the IBP setup Menu to make a zero calibration.
4. Set the patient simulator as P (static) = 200 mmHg.
5. The displayed value should be within 200 ± 4 mmHg.
6. If the error is beyond ± 4 mmHg, calibrate the pressure module. If the IBP module was calibrated with a
dedicated reusable IBP sensor, check the calibration together with this IBP sensor.
7. Let the patient simulator output 120/80 mmHg ART signal and 120/0 mmHg LV signal to the IBP channel and
check that the IBP wave is displayed correctly.
8. Repeat the steps above to calibrate other IBP channels.
IBP Pressure Calibration
Method 1:
Tools required:
Medsim300B patient simulator, or MPS450, or equivalent equipments
IBP adapter cable for test (P/N 009-002199-00 for Medsim 300B, P/N 009-002198-00, for MPS450)
1. Connect the patient simulator through the monitor's IBP connector.
2. Set the patient simulator to 0 for the desired IBP channel.
3. Select IBP Zero in the IBP setup Menu to make a zero calibration.
4. Set the patient simulator as P (static) = 200 mmHg.
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k
5. Select [Main Menu→] [Maintenance >>→] [Cal. IBP Press. >>]. In the [Cal. IBP Press.] menu, set the
calibration value to 200 mmHg.
6. Select the [Calibrate] button next to the desired IBP channel to start calibration.
7. If the calibration is completed successfully, the message [Calibration Completed!] will be displayed. Otherwise,
Before disassembling the equipment, finish the following preparations:
Stop patient monitoring, turn off the equipment, and disconnect all the accessories and peripheral devices.
Disconnect the AC power source and remove the battery.
WARNING
Before disassembling the equipment, be sure to eliminate the static charges first. When disassembling the
parts labeled with static-sensitive symbols, make sure you are wearing electrostatic discharge protection
such as antistatic wristband or gloves to avoid damaging the equipment.
Properly connect and route the cables and wires when reassembling the equipment to avoid short circuit.
Select appropriate screws to assemble the equipment. If unfit screws are tightened by force, the
equipment may be damaged and the screws or part may fall off during use, causing unpredictable
equipment damage or human injury.
Follow correct sequence to disassembly the equipment. Otherwise, the equipment may be damaged
permanently.
Be sure to disconnect all the cables before disassembling any parts. Be sure not to damage any cables or
connectors.
Be sure to place removed screws and disassembled parts properly, preventing them from being lost or
contaminated.
Place the screws and parts from the same module together to facilitate reassembling.
To reassemble the equipment, first assemble the assemblies, and then the main unit. Carefully route the
cables.
Make sure that the waterproof material is properly applied during reassembling.
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7.3 Disassembling the Main Unit
NOTE
The recorder can be disassembled separately.
To disassemble the equipment, place the equipment on a work surface free from foreign material,
avoiding damaging the antiglare screen, touchscreen and the knob. Be careful not to break the two cotters
on the front ends of rear housing.
All the operations should be performed by qualified service personnel only. Make sure to put on the
insulating gloves during service operations.
Operations relating to optional parts may not apply to your equipment.
7.3.1 Separating the Front and Rear Half of the Monitor
1. Lay the monitor on a flat platform with the knob overhanging as shown below. Then unscrew the two M3×10
screws on the rear panel and the two M3×6 screws on the bottom of the patient monitor.
2. Stand the patient monitor and separate the front housing assembly and rear housing assembly with caution.
Disconnect the cable between the main board and keypad board and then take off the front panel.
Cable between the main
board and keypad board
NOTE
When reassembling the equipment, be sure to check if the front housing waterproof strip is correctly
placed.
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7.3.2 Disassembling Parameter Modules
Lay the patient monitor on a flat platform and unscrew the five M3×5 screws as shown below. Disconnect the cable
between the power management board and multi-parameter board, and then take out the parameter module.
Cable between the power
management board and
multi-parameter board
7.3.3 Removing the Parameter Connector Panel Assembly
Unscrew the three M3×6 screws as shown below and separate the parameter connector panel assembly and
parameter board assembly.
7.3.4 Removing the SpO
1. Unscrew the two M3×4 screws and take out the SpO2 board and insulation plate.
Board and Parameter Board
2
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2. Unscrew the four M3×6 screws, disconnect the pump cable and valve cable, and then take out the SpO2 board.
Pump cable
Valve cable
7.3.5 Removing Pump and Valve
Unscrew the two M3×6 screws and take out the valve. Then cut the two fixing strips to take out the pump.
7.3.6 Removing the Recorder (Optional)
Unscrew the four M3×6 screws and disconnect the recorder cable to remove the recorder.
NOTE
The recorder can be disassembled separately.
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7.3.7 Removing Battery Interface Board and Power Board (iPM 5/iPM 6/iPM 8/iPM 10)
1. Unscrew the three M3×6 screws inside the patient monitor and the four M3×6 screws on the bottom as shown
below:
2. Disconnect the cable between battery interface board and power management board, and the cable between
the power management board and AC/DC power board. Then take out the battery compartment assembly.
Cable between the power
management board and
AC/DC power board
Cable between the battery in
terface board and power ma
nagement board
3. Unscrew the two M3 nuts to take out the battery interface board.
4. Unscrew the three M3×6 screws to remove the AC/DC power board.
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5. Unscrew the M3×6 screw and the flat head screw fixing the AC input receptacle assembly, then loose the screw
that fixes the grounding cable to take out the AC input receptacle assembly.
7.3.8 Removing the Battery Interface Board and Power Board (iPM 7/iPM 12)
1. Unscrew the two M3×6 screw inside the patient monitor and then the two M3×6 screws on the bottom. Then
disconnect the cable between the battery interface board and power management board to remove the battery
compartment assembly.
2. Unscrew the four M3×6 screws to take out the battery interface board assembly.
3. Unscrew the two M3×6 screws inside the patient monitor and then the two M3×6 screws on the bottom. Then
disconnect the cable between the battery interface board and the power management board to remove the
power board assembly.
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4. Unscrew the five M3×6 screws that fix the AC input receptacle assembly and then the screw that fixes the
grounding cable. Unplug the AC input receptacle and cable from the board to remove the AC input receptacle
assembly.
5. Unscrew the three M3×6 screws to remove the AC/DC power board.
AC input receptacle and cable
7.3.9 Removing the Power Management Board
Unscrew the seven M3×6 screws inside the patient monitor, disconnect all the cables, and then take out the power
management board.
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7.3.10 Removing the Interface Board (iPM 5/iPM 8)
Unscrew the three M3×6 screws inside the patient monitor and take out the interface board.
7.3.11 Removing the Interface Board (iPM 6/iPM 7/iPM 10/iPM 12)
Unscrew the three M3×6 screws inside the patient monitor and take out the interface board.
7.4 Disassembling the Front Housing Assembly
NOTE
To disassemble the equipment, place the equipment on a work surface free from foreign material,
avoiding damaging the antiglare screen, touchscreen and the knob.
Remember to install the screen support pad properly during reassembly.
Operations relating to optional parts may not apply to your equipment.
Position the touchscreen properly with the flexible cable facing down.
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7.4.1 Removing Touchscreen Control Board (Optional)
Loose and unscrew the two M3×6 screws as shown below. Disconnect the touchscreen cable and cable for
touchscreen control board, and then remove the touchscreen control board.
Touchscreen cable
7.4.2 Removing the Wi-Fi Module (Optional)
1. Take out the two antennas on the front panel from the slots as shown below:
Antenna
2. Remove the antennas from the Wi-Fi module PCBA.
Antenna
Antenna
Antenna
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3. Push the clamps aside to remove the Wi-Fi module.
Clamps
7.4.3 Removing SD Card (Optional)
Unscrew the M3×6 screw, and push the SD card as indicated below to take out the SD card.
Clamps
7.4.4 Removing the Main Control Board
Disconnect the alarm lamp cable, cable for display backlight, display cable, and the cable between the main board
and keypad board respectively. Unscrew the four M3×8 screws and take out the main board, as shown below:
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7.4.5 Removing the Touchscreen (Optional)
Unscrew the nine M3×6 screws as indicated below. Take out the touchscreen assembly and then the touchscreen.
7.4.6 Disassembling the Screen
Unscrew the four M3×6 screws indicated below to remove the screen.
7.4.7 Removing the Keypad
Unplug the encoder cable and unscrew the five PT3×8 screws indicated below. Take out the keypad.
7.4.8 Removing the Encoder
Poke the encoder knob out from the slot and loose the nut with a sharp nose plier. Take out the encoder.
Knob
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7.4.9 Removing the Alarm Lamp Board
Unscrew the two M3×6 screws indicated below and take out the alarm lamp board.
7.5 Disassembling Modules
7.5.1 Removing the External Converter Board
Unscrew the four M3×8 screws and disconnect the cable between the converter board and copper board to remove
the converter board.
7.5.2 Separating the Front and Rear Housing of Modules
1. For AG modules, unscrew the four M3×8 screws on the bottom before separating the front and rear housing.
Cable between the
converter board and
copper board
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2. For other modules, unscrew the two M3×6 screws on the back to separate the front and rear housing.
7.5.3 Removing the External Module Interface Board
Unscrew the two M3×6 screws, disconnect all the cables from the board, and then remove the module interface
board.
7.5.4 Removing M03B Module
Disconnect all the cables from the M03B module and push the clamp on the bracket to remove the M03B module.
Clamp
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7.5.5 Removing Sidestream CO
1. Unscrew the 3 screws that fix the bracket and connector panel. Disconnect all the cables and tubes that connect
the bracket and connector panel. Then separate the connector panel and bracket.
Module
2
NOTE
Manage the tubes properly during reassembly and make sure the tubes shaping smooth.
2. Unscrew the four screws that fix the M02C module, and then take out the M02C module.
7.5.6 Removing Microstream CO
1. Unscrew the 3 screws that fix the bracket and connector panel. Disconnect all the cables and tubes that connect
the bracket and connector panel. Then separate the connector panel and bracket.
Module
2
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2. Unscrew the three M3×8 screws that fix the microstream CO2 module, and then remove the microstream CO2
module.
7.5.7 Removing AG Module
1. Unscrew the three M3×6 screws and the captive screw that fix the AG module bracket and connector panel. Then
disconnect all the cables and tubes connecting the connector panel and the AG module to separate the
connector panel and bracket.
2. Unscrew the six M3×6 screws that fix the AG module and remove AG module.
NOTE
Manage the tubes properly during reassembly and make sure the tubes shaping smooth.
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FOR YOUR NOTES
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8 Parts
8.1 Introduction
This section contains the exploded views and parts lists of the main unit. It helps the engineer to identify the parts
during disassembling the patient monitor and replacing the parts. This manual is based on the maximum
configuration. Your equipment may not have same parts and the quantity of the screws or stacking sleeves etc. may
be different with those included in the parts lists.
Hardware architecture of the main unit is shown below:
NOTE
The part number listed in the Parts List is only for checking the FRU part number which is also included in
the Parts List. Please provide the FRU parts number if you want to purchase the spare parts.