Professional Documents
Culture Documents
Defibrillator/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.
Revision History
This manual has a revision number. This revision number changes whenever the manual is
updated due to software or technical specification change. Contents of this manual are subject
to change without prior notice.
Version number 7.0
Release time: May 2011
2009-2011 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
I
Preface
Manual Purpose
This manual provides detailed information about the assembling, dissembling, testing and
troubleshooting of the equipment to support effective troubleshooting and repair. It is not
intended to be a comprehensive, in-depth explanation of the product architecture or technical
implementation. Observance of the manual is a prerequisite for proper equipment
maintenance and prevents equipment damage and personnel injury.
Intended Audience
This manual is for biomedical engineers, authorized technicians or service representatives
responsible for troubleshooting, repairing and maintaining the defibrillator/ monitors
Passwords
Passwords may be required to access different modes. The passwords are listed below:
II
Contents
1
4.2.1 Visual Test .......................................................................................................... 4-4
4.2.2 NIBP Tests.......................................................................................................... 4-4
4.2.3 CO2 Module Tests............................................................................................... 4-7
4.2.4 Preventative maintenance test report.................................................................. 4-8
4.3 Power On Test ................................................................................................................. 4-9
4.4 User Test........................................................................................................................ 4-10
4.5 Password for Installation Mode .....................................................................................4-11
4.6 Module Performance Tests.............................................................................................4-11
4.6.1 Manual Defibrillation Test ................................................................................4-11
4.6.2 Pacing Test ....................................................................................................... 4-13
4.6.3 ECG Test .......................................................................................................... 4-14
4.6.4 Resp Test .......................................................................................................... 4-15
4.6.5 IBP Tests........................................................................................................... 4-15
4.6.6 SpO2 Test.......................................................................................................... 4-17
4.6.7 Temp Test ......................................................................................................... 4-17
4.7 Analogue Output Test.................................................................................................... 4-18
4.8 Electrical Safety Tests ................................................................................................... 4-18
4.9 Recorder Check............................................................................................................. 4-18
4.10 Factory Service ........................................................................................................... 4-18
4.10.1 Password for Service Mode............................................................................ 4-18
4.10.2 Accessing Service Mode Menu ...................................................................... 4-19
4.10.3 Calibrating NIBP............................................................................................ 4-19
4.10.4 Calibrating/Zeroing Impedance...................................................................... 4-19
4.10.5 Device Information ........................................................................................ 4-21
4.10.6 Checking Failure Code................................................................................... 4-21
4.10.7 Inputting Serial Number................................................................................. 4-22
4.10.8 Paddle Open Circuit Display.......................................................................... 4-22
4.10.9 Selecting Recorder Type ................................................................................ 4-22
6 Troubleshooting................................................................................................................ 6-1
2
6.1 Overview......................................................................................................................... 6-1
6.2 Part Replacement ............................................................................................................ 6-1
6.3 Checking Defibrillator/Monitor Status............................................................................ 6-1
6.4 Checking Device Information ......................................................................................... 6-2
6.5 Checking Technical Alarm .............................................................................................. 6-2
6.6 Troubleshooting Guide.................................................................................................... 6-3
6.6.1 Defibrillation Problems ...................................................................................... 6-3
6.6.2 Pacing Problems................................................................................................. 6-5
6.6.3 Power On/Off Problems ..................................................................................... 6-5
6.6.4 Display Problems ............................................................................................... 6-6
6.6.5 Alarm Problems.................................................................................................. 6-7
6.6.6 Button and Knob Problems ................................................................................ 6-8
6.6.7 Recorder Problems ............................................................................................. 6-9
6.6.8 Output Interface Problems ................................................................................. 6-9
6.6.9 CF Card Problems ............................................................................................ 6-10
6.6.10 Wireless Transmission Module Problems ...................................................... 6-10
6.6.11 Power Supply Problems ..................................................................................6-11
6.6.12 Software Upgrade Problems........................................................................... 6-12
6.7 Technical Alarm Messages............................................................................................ 6-12
6.8 Error Codes ................................................................................................................... 6-13
6.8.1 Therapy Module Error Codes........................................................................... 6-13
6.8.2 Power Module Error Codes.............................................................................. 6-14
6.8.3 Main Control Error Codes................................................................................ 6-15
6.8.4 MPM Error Codes ............................................................................................ 6-15
3
7.4.3 Removing the Speaker ..................................................................................... 7-20
7.4.4 Removing the Indicating Lamp Board and Alarm Lamp Board ...................... 7-20
7.4.5 Removing the Mode Select Knob .................................................................... 7-21
7.4.6 Removing the Rotary Encoder ......................................................................... 7-22
7.4.7 Removing the Recorder.................................................................................... 7-22
7.5 Disassembling the MPM Module.................................................................................. 7-23
7.5.1 Removing the Fan ............................................................................................ 7-23
7.5.2 Removing the SpO2 board ............................................................................... 7-24
7.5.3 Removing the MPM Module Analog Board .................................................... 7-25
7.5.4 Removing the MPM Module Digital Board..................................................... 7-26
7.5.5 Removing the NIBP Module............................................................................ 7-27
7.6 Disassembling the Power Supply Assembly ................................................................. 7-28
7.6.1 Removing the AC/DC board ............................................................................ 7-28
7.6.2 Removing the Power Supply Sheet Metal and the Grounding Terminal.......... 7-29
7.7 Disassembling the CO2 Module ................................................................................... 7-30
7.7.1 Disassembling the Microstream CO2 Module ................................................. 7-30
7.7.2 Disassembling Mindray CO2 Module.............................................................. 7-31
7.8 Disassembling the Measurement Module Panel Assembly........................................... 7-32
7.8.1 Disassembling the Measurement Module Panel with Mindray CO2 Module.. 7-32
7.8.2 Disassembling the Measurement Module Panel with Microstream CO2 Module
................................................................................................................................... 7-33
7.8.3 Disassembling the Measurement Module Panel without CO2 Module ........... 7-33
7.9 Disassembling the Recorder.......................................................................................... 7-34
7.9.1 Disassembling the TR6F Recorder................................................................... 7-34
7.9.2 Disassembling the TR8A Recorder .................................................................. 7-35
7.10 Disassembling the External Paddle ............................................................................. 7-37
7.10.1 Disassembling the Adult Paddle..................................................................... 7-37
7.10.2 Disassembling the Apex Pediatric Paddle ...................................................... 7-37
7.10.3 Disassembling the Sternum Pediatric Paddle ................................................. 7-38
4
8.6 Measurement Module Panel Assembly ......................................................................... 8-12
8.6.1 Exploded View ................................................................................................. 8-12
8.6.2 Parts List .......................................................................................................... 8-12
8.7 Power Supply Assembly ............................................................................................... 8-14
8.7.1 Exploded View ................................................................................................. 8-14
8.7.2 Parts List .......................................................................................................... 8-15
8.8 MPM Module................................................................................................................ 8-16
8.8.1 Exploded View ................................................................................................. 8-16
8.8.2 Parts List .......................................................................................................... 8-17
8.9 Capacitor Assembly ...................................................................................................... 8-18
8.9.1 Exploded View ................................................................................................. 8-18
8.9.2 Parts List .......................................................................................................... 8-18
8.10 Sidestream CO2 Module Kit ....................................................................................... 8-19
8.10.1 Exploded View ............................................................................................... 8-19
8.10.2 Parts List ........................................................................................................ 8-19
8.11 Microstream CO2 Module Kit .................................................................................... 8-20
8.11.1 Exploded View ............................................................................................... 8-20
8.11.2 Parts List......................................................................................................... 8-20
8.12 Paddle Tray Assembly................................................................................................. 8-21
8.12.1 Exploded View ............................................................................................... 8-21
8.12.2 Parts List ........................................................................................................ 8-21
8.13 External Paddle ........................................................................................................... 8-22
8.13.1 Exploded View ............................................................................................... 8-22
8.13.2 Parts List ........................................................................................................ 8-22
8.14 Sternum Pediatric Paddle Kit ...................................................................................... 8-23
8.14.1 Exploded View ............................................................................................... 8-23
8.14.2 Parts List ........................................................................................................ 8-23
8.15 Sternum Adult Paddle Kit ........................................................................................... 8-24
8.15.1 Exploded View ............................................................................................... 8-24
8.15.2 Parts List ........................................................................................................ 8-24
8.16 Apex Pediatric Paddle Kit ........................................................................................... 8-25
8.16.1 Exploded View ............................................................................................... 8-25
8.16.2 Parts List ........................................................................................................ 8-25
8.17 Apex Adult Paddle Kit ................................................................................................ 8-26
8.17.1 Exploded View ............................................................................................... 8-26
8.17.2 Parts List ........................................................................................................ 8-26
8.18 External Paddle Cable ................................................................................................. 8-27
8.18.1 Exploded View ............................................................................................... 8-27
8.18.2 Parts List ........................................................................................................ 8-27
8.19 Hook Mount ................................................................................................................ 8-28
8.19.1 Exploded View ............................................................................................... 8-28
8.19.2 Parts List ........................................................................................................ 8-28
8.20 Replacement Parts....................................................................................................... 8-29
8.20.1 Main Unit ....................................................................................................... 8-29
5
8.20.2 Connecting Cables ......................................................................................... 8-32
6
1 Safety
1.1 Safety Information
DANGER
z Indicates an imminent hazard that, if not avoided, will result in death, serious
personal injury or property damage.
WARNING
z Indicates a potential hazard or unsafe maintenance practice that, if not avoided,
could result in death, serious personal injury, product / property damage.
CAUTION
z Indicates a potential hazard or unsafe maintenance 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 can better
service your product.
1-1
1.1.1 Dangers
WARNING
z Do not open the equipment cases to avoid shock hazard. All servicing and future
upgrades must be carried out by the personnel trained and authorized by our
company only.
1.1.2 Warnings
WARNING
z To avoid high voltage shock, disconnect the defibrillator/monitor from AC adapter
and remove the batteries before disassembly.
z The equipment must be connected to a properly installed power socket with
protective earth contacts only. If the installation does not provide a protective
earth conductor, do not use this socket and operate the equipment on rechargeable
batteries.
z When disposing of the packaging material, be sure to observe the applicable waste
control regulations and keep it out of childrens 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 equipment to the power line, check that the voltage and
frequency ratings of the power line are the same as those indicated on the
equipments label or in this manual.
z Protect the equipment from damage caused by drop, impact, strong vibration or
other mechanical force during servicing.
1-2
1.1.4 Notes
NOTE
z Refer to Operation Manual for detailed operation and other information.
1-3
FOR YOUR NOTES
1-4
2 Theory of Operation
2.1 The Basics
2.1.1 Overview
BeneHeart D6 defibrillator/monitor (hereinafter called the equipment) provides four
operating modes: Manual Defib, AED, Pacer, and Monitor. The equipment is for use in
hospital and pre-hospital settings. It adopts the most advanced biphasic defibrillation
technology and can deliver up to 360J of defibrillation energy.
BeneHeart D6 has an 8.4" LCD display.
AED Mode
In AED mode, the equipment automatically analyzes the patients ECG rhythm and
indicates whether or not a shockable rhythm is detected. Voice prompts provide
easy-to-follow instructions and patient information to guide you through the
defibrillation process. Messages and flashing buttons are also presented to reinforce the
voice prompts.
Pacer Mode
The Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are
delivered through multifunction electrode pads using a monophasic square waveform.
2-1
Monitor Mode
In Monitor Mode, the equipment is intended for monitoring, displaying, reviewing,
storing and printing multiple physiological parameters and waveforms including ECG,
pulse oximetry (SpO2), temperature (Temp), non-invasive blood pressure (NIBP),
invasive blood pressure (IBP) and carbon dioxide (CO2).
2.2 Components
The equipment consists of a main unit, accessories and PC software.
The main unit is composed of the front housing assembly, rear housing assembly and the
paddle tray assembly. External paddles are rested in the paddle tray.
The front housing assembly mainly consists of LCD, keypad board, recorder, speaker,
microphone, Mode Select knob, navigation knob, backlight inverter, alarm lamp board,
indicating lamp board, front housing and front housing sheet metal, etc.
The rear housing assembly consists of CPU board, therapy module, high voltage
capacitors, MPM module, CO2 module, power management board, wireless network
adapter, fan, measurement module panel, therapy port, and rear housing, etc.
The paddle tray is for holding the external paddles.
2-2
The main unit consists of the following subsystem:
Input subsystem: Its input includes keypad board, microphone, Mode Select knob,
navigation knob, and paddle handle controls.
Output subsystem: includes display screen, alarm lamp board, recorder, and speaker
Processing and communication subsystem: includes CPU board, therapy module, MPM
module, and CO2 module.
Power management subsystem: includes batteries, AC/DC board and power
management board.
External device connection subsystem: includes USB connector, network connector,
VGA connector and multifunction connector for analog output and synchronous input.
System Structure
2-3
System Signal Flow
Navigation Knob
You can rotate the knob clockwise or counterclockwise and then press it to confirm a
selection. The knob is connected to the keypad board.
Recorder
The recorder receives data from the CPU board and then sends the data to a thermal head for
printing. The recorder front panel has a key for starting/ stopping the recorder and a green
indicator which is lit when working normally. The recorder is connected to the keypad board
which board provides connection for the TR6F recorder. The block diagram and functional
modules of the recorder are shown as below.
2-4
Module Description
Power Interface Introduces DC power supply from the CPU board.
Recorder Power Module Adjusts input voltage to run each module.
Coordinates module communication, controls and processes module
Recorder CPU
status.
Serves as the data communication channel between the keypad board
Keypad board Interface
and the recorder CPU.
Receives control signals sent by the recorder CPU to drive the step
Motor Drive Circuit
motor.
Keypad and Indicator Sends keypad commands to CPU and receives CPU commands to
Interface control the indicator.
Sends print head information to CPU and receives CPU commands to
FPC Interface
control the print head.
Speaker
The speaker emits alarm tones, key-stroke tone, heart beats and PR sound. It supports the
functions of PITCH TONE and the multi-level volume. The speaker is connected to the
keypad board.
Microphone
It provides the function of voice recording.
2-5
2.5 Paddle Tray
The paddle tray is used to hold paddles. It has a 50 test load inside. When the equipment
runs self tests, test current will pass through the test load.
2-6
2.6.2 Main Control System
The CPU board is connected with the power management board with stacking connectors, as
shown below.
The main control module mainly consists of the CPU and FPGA. CPU is used to provide
least required internal storage, program memory, large capacity non-volatile storage, and the
watch dog. It connects EEPROM and other peripheral ICs such as Ethernet PHY chip. FPGA
performs the main functions of display and audio. Besides, it has the function of adapting
interfaces from CPU to MPM module, the keypad board and the recorder. CPU controls
FPGA via Flexbus.
The therapy module adopts DSP+MCU framework. MCU is responsible for therapy control
while DSP for ECG and impedance detection, AED algorithm, monitoring algorithm, pacing
algorithm, auxiliary therapy control, etc.
2-7
2.7 External Device Connectors
6
7
2
3 9
4 5
1. Hook
2. Battery 2
3. Battery 1
4. External power input: It connects an AC power cord or a DC/AC adapter to run the
equipment respectively on the external AC mains or DC power supply.
5. Equipotential grounding terminal: When the defibrillator/monitor and other devices are
to be used together, their equipotential grounding terminals should be connected
together to eliminate the potential difference between them.
6. USB connector: It connects the USB memory for data export. Data stored in the internal
CF card can be transferred to the USB memory and then export to a PC via the data
management software.
7. Network connector: It is a standard RJ45 connector, through which software can be
upgraded.
8. Multifunctional connector: provides ECG analog output and defibrillation
synchronization input.
9. VGA connector: connects an external VGA display.
2-8
3 Unpacking and Installation
This chapter provides information you need to install a defibrillator/monitor ready for use.
Accessory packing
3-1
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 defibrillator/monitor needs to be
connected to network.
WARNING
z Only power cables provided with the system may be used. For reasons of safety,
power (mains) extension cables or adapters shall not be used.
Environmental Requirements
WARNING
z To avoid explosion hazard, do not use the equipment in the presence of flammable
anaesthetics, vapours or liquids.
CAUTION
z The environment where the defibrillator/monitor will be used should be reasonably
free from vibration, dust and corrosive substances. If these conditions are not met,
the accuracy of the system may be affected and damage may occur.
3-2
3.2.2 Electrical Requirements
Check cables and power cords. Make sure that:
1. All system cables, power cords and power plugs are not damaged, and pins are not loose.
Otherwise, remove it from use.
2. The insulation of patient cables and leadwires is not damaged, and connectors are not
loose.
WARNING
z Only power sockets with protective grounding can be used.
3-3
3.6 User Test
A user test shall be performed after the defibrillator/monitor is installed. Follow this
procedure:
1. Connect AC mains or install the battery.
2. Connect the external paddles. If pads are used, connect the test load.
3. Select the Main Menu button on the equipments front panel and select [User Test >>].
Select all test items and press [Start] to perform user test.
NOTE
z Install the battery and properly place the external paddles in the paddle tray or
connect the pads cable and 50 test load. Otherwise the User Test will fail.
Refer to BeneHeart D6 Operating Manual for the detailed information on user test.
3-4
4 Testing and Maintenance
4.1 Introduction
To ensure the equipment always functions normally, qualified service personnel should
perform regular inspection, maintenance and test. This chapter provides a checklist of the
testing procedures for the equipment with recommended test equipment and frequency. The
service personnel should perform the testing and maintenance procedures as required and use
appropriate test equipment.
The testing procedures provided in this chapter are intended to verify that the equipment
meets the performance specifications. If the equipment or a module fails to perform as
specified in any test, repairs or replacement must be done to correct the problem. If the
problem persists, contact our Customer Service Department.
CAUTION
z All tests should be performed by qualified service personnel only.
z Care should be taken to change the settings in [Installation Mode] and [Service
Mode] menus to avoid loss of data.
z Before testing, service personnel should acquaint themselves with the test tools and
make sure that test tools and cables are applicable.
z When testing monitoring parameters, move the Mode Select knob to Monitor to
access the Monitor Mode.
z When performing therapy function tests, move the Mode Select knob to
corresponding mode.
4-1
4.1.1 Test Report
After completing the tests, service personnel are required to record test results and report
them to Mindray Customer Service Department.
See the
Test Report at the end of this chapter.
Visual inspection
NIBP test and calibration
Microsteam and Sidestram CO2 test and calibration.
4-2
4.1.3 Recommended Frequency
After Function 6 12 24
Test item
repair suspected months months months
Visual inspection
Power-on Test
User test
Recorder check
Charge/
Manual discharge
defibrillation Energy disarming
tests Synchronous
defibrillation
Pacing test
Performance test
ECG
Module calibration
Resp Performance test
SpO2 Performance test
Temp Performance test
Accuracy test
NIBP Leakage test
Module calibration
Performance test
IBP
Pressure calibration
Leakage test
CO2
Module calibration
4-3
4.2 Preventative Maintenance Procedures
4.2.1 Visual Test
Inspect the equipment for obvious signs of damage. The test is passed if the equipment has no
obvious signs of damage. Follow these guidelines when inspecting the equipment:
Carefully inspect the housing, the display screen and the buttons for physical damage.
Inspect accessories for 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.
Defibrillator/monitor
Manometer
Connector for Tubing
NIBP cuff
2. Before inflation, the reading of the manometer should be 0. If not, disconnect the airway
and reconnect it until the readings is 0.
3. Press the Main menu button on the equipments front panel. Select
[Others>>][Installation Mode>>] enter the required password[Maintain
NIBP] [Start Accuracy Test].
4-4
4. Compare the value of manometer with the value displayed on the equipments screen.
The difference should be no greater than 3 mmHg.
5. Raise the pressure in the metal vessel to 50 mmHg with the balloon pump. Repeat steps
3 and 4.
6. Raise the pressure in the metal vessel to 200 mmHg with the balloon pump. Repeat steps
3 and 4.
Note
z You can replace the balloon pump and manometer with a blood pressure simulator
to form a test system.
Cylinder
Defibrillator/monitor
3. Press the Main menu button on the equipments front panel. Select [Others>>]
[Installation Mode>>] enter the required password[Maintain NIBP] [Start
Leakage Test].
After about 20 seconds, the equipment automatically deflates. This means the leakage test
finishes.
When the accuracy test is completed, the result will be displayed. If the message [NIBP
Pneumatic Leak] is displayed, it indicates that the NIBP airway may have leakages. Check
the tubing and connections for leakages, and then perform a leakage test again.
4-5
Calibrating NIBP
Tools required:
T-shape connector
Tubing
Balloon pump
Metal Vessel, volume 50025 ml
Calibrated manometer, accuracy higher than 1 mmHg
Defibrillator/monitor Manometer
Balloon pump
Metal vessel
2. Before inflation, the reading of the manometer should be 0. If not, disconnect the
airway and reconnect it until the readings is 0
3. Press the Main menu button on the equipments front panel. Select [Others>>]
[Service Mode>>] enter the required password[Calibrate NIBP].
4. Calibrate pressure. To do so, set the calibration value to 150 mmHg and adjust the pump
output pressure to 150 mmHg. After the system is stable, click the [Calibrate] button to
start calibration.
5. Calibrate overpressure. To do so,
set [Patient Cat.] to [Adu/Ped] and adjust pump output pressure to 330 mmHg.
Click the [Calibrate] button and start calibration. Or
set [Patient Cat.] to [Neo] and adjust pump output pressure to 165 mmHg. Click
the [Calibrate] button and start calibration.
All the calibration results will be displayed in the [Calibrating NIBP] screen. If the
calibration fails, please check the connections and then perform a calibration again.
4-6
4.2.3 CO2 Module Tests
Leakage Check
1. Access the [CO2 Setup] menu and set [Operating Mode] to [Measure].Wait for CO2
warm-up.
2. Block the CO2 module gas inlet completely. This will cause different reactions from the
Sidestream and Microstream CO2 modules.
Sidestream: Check that alarm message [CO2 Filter Line Err] is displayed on the
screen in 3s. Block the gas inlet for another 30s, if the alarm message does not
disappear, the module does not leak.
Microstream CO2 module: [CO2 Purging] is displayed in 3s. Block the gas inlet
for another 30s, if the alarm message [CO2 Tubing Err] appears, the module does
not leak.
Module Calibration
Test tools
Gas cylinder, with 6% of CO2 and balance gas N2.
T-shape connector
Tubing
For sidestream CO2 module, zeroing is required before calibration. Enter [CO2 Setup] menu
and select [Zero] to perform zeroing.
To the air
Tubing
Gas valve
Defibrillator
/monitor
Gas cylinder
4-7
3. Vent the tubing to the CO2 by opening the gas valve.
4. Access the [Maintain CO2] menu. To do so, Press the Main Menu button on the
equipments front panel. Select [Others>>][Installation Mode>>] enter the
required password [Maintain CO2].
5. In the [Maintain CO2] menu, select a CO2 value equal to the vented CO2
concentration.
6. In the [Calibrate CO2] menu, the measured CO2 concentration is displayed. Wait till
the measured CO2 concentration becomes stable; select [Calibrate] to start CO2
calibrate.
The message [Calibration Completed!] is displayed after a successful calibration. If the
calibration failed, the prompt [Calibration Failed!] will be displayed. In this case, perform
another calibration.
Customer address
Servicing person
Servicing company
Model of EUT
SN of EUT
Hardware version
Software version
4-8
Test items Test records Test results
(Pass/Failed)
Visual inspection
NIBP test
4-9
4.4 User Test
Follow this procedure to perform user test:
1. If you use external paddles, place them on the paddle tray; if you use a pads cable,
connect it to the 50 test load.
2. Insert the battery (2 if configured) into the equipment. Connect the AC mains if no
battery is available.
3. Select the Main Menu button on the equipments front panel. In the Main Menu, select
[User Test>>]. Then a prompt Enter user test? pops up. Select Yes to enter the User
Test screen.
4. Check the test items you want to perform and select [Start] to start user test
The test results indicate the condition of the system. If any item fails, the service indicator
flashes.
If you cannot pass User Test or the message Connect paddles cable, and place paddles in
paddle tray is shown when paddle cable is connected and paddles are placed in paddle tray,
check paddles status.
Select the Monitor mode. Press and hold the [Event] hardkey, and then press the [Lead
Select] hardkey on the front panel, the following screen appears.
4-10
4.5 Password for Installation Mode
Accessing installation mode is password protected. The required password is set to 888888
before the equipment leaves the factory.
Charge/Discharge
1. Remove the batteries and connect the equipment with AC mains. Turn the Mode Select
knob to Manual Defib.
2. Connect the external paddles to the equipment and place the paddles on the
defibrillator/pacer analyzer.
3. Enter the Configuration-Main screen. From the Record Setup menu set [Shock Event]
to [On] so that shock events can be recorded automatically if happened.
4. Set the analyzer to Energy Measurement mode. In this case, the energy value should be
displayed as 0 or blank.
5. Select the energy level to 1J.
6. Charge/discharge the equipment to verify the energies measured by the analyzer meet
the following accuracy:
4-11
Energy Disarming
1. Run the equipment on fully charged battery. Move the Mode Select knob to Manual
Defib.
2. Connect the external paddles to the equipment and place the paddles on the
defibrillator/pacer analyzer.
3. Set the analyzer to Energy Measurement mode. In this case, the energy value should be
displayed as 0 or blank.
4. Select the energy level to 360J.
5. Charge the equipment.
6. Verify that the charge tone is issued during charging.
7. Press the Disarm soft key to discharge the energy internally.
8. Verify that a prompt Charge Removed appears and the charge done tone stops.
9. Verify that the value measured by the analyzer is 0J or blank.
10. Enter the Configuration-Main menu, select [Manual Therapy Setup] and set [Time to
Auto Disarm] to [60s].
11. Exit Configuration Management. The equipment restarts automatically.
12. Set the analyzer to Energy Measurement mode. In this case, the energy value should be
displayed as 0 or blank.
13. Select the energy level to 360J.
14. Charge the equipment. Count time after charging is completed.. Verify that the prompt
Shock Removed appears on the equipment and the energy measured by the analyzer is
0J or blank after 60 seconds.
15. Use multifunctional electrode pads. Repeat Step 3 to Step 14.
Synchronous Defibrillation
1. Connect the external paddles and ECG cable to the equipment. Place the paddles ECG
electrodes on the defibrillator/pacer analyzer.
2. Set the analyzer to Measurement Mode and output normal sinus rhythms, e.g. amplitude
value 1mV and HR 60bpm.
3. Enter Configuration Management. In the [Manual Therapy Setup] menu, set [Sync
After Shock] to [On].
4. Adjust the energy setting of the equipment to be 10J.
5. Press the [Sync On] soft key to start synchronous defibrillation. If Remote Sync is
switched on, press the [Sync On] soft key and select [Local] to start synchronous
defibrillation
6. Select [Pads] or [Paddles] as the ECG source and begin charging.
4-12
7. When charging finishes, press and hold the Shock button to deliver a shock.
8. Verify that synchronous discharge succeeds and the delivery energy measured by the
analyzer is 10J2J.
9. Verify that the delay time of synchronous defibrillation measured by the analyzer is less
than 60ms.
10. Verify that the synchronous discharge mark appears on the R wave.
11. Verify that the prompt messages are correct during testing.
12. Select lead II as ECG source and perform charging. Repeat steps 7 to 11.
13. Use multifunctional electrode pads. Repeat steps 2 to 12.
1. Run the equipment on fully charged battery. Move the Mode Select knob to Pacer. Set
[Pacer Mode] to [Fixed].
2. Connect the pads cable to the equipment and properly place the pads on the
defibrillator/pacer analyzer.
3. Set the analyzer to Pacing Measurement mode. Use test load of 50.
4. On the equipment, set [Pacer rate] to [70ppm] and [Pacer Output] to [30mA].
5. Press the [Start Pacing] soft key. Verify that the pacer rate measured by the analyzer is
70 ppm1ppm and the pacer output measured is 30 mA5mA.
6. Press the Stop Pacing soft key, and then set [Pacer rate] to [170ppm] and [Pacer
Output] to [200mA].
7. Press the [Start Pacing] soft key. Verify that the pacer rate measured by the analyzer is
170 ppm2ppm, and the measured current is 200 mA10mA.
4-13
4.6.3 ECG Test
Performance Test
Test tools
ECG simulator
ECG Calibration
1. Select the ECG parameter area to enter the [ECG Setup] menu.
2. Select [Others>>][Calibrate]. A waveform signals appear on the screen and the
message [ECG Calibrating] is displayed in the prompt information area in the lower
left corner of the screen.
3. Compare the amplitude of the waveform with the wave scale. The difference should be
within 5%. If needed, you can also print out the waveform and the wave scale.
4. After ECG calibration is completed, select [Stop Calibrating].
4-14
4.6.4 Resp Test
Test tools
Resp Patient simulator
4-15
Pressure Calibration
Tools required:
Standard sphygmomanometer
Balloon pump
Tubing
T-shape connector
To perform a calibration:
1. Connect the 3-way stopcock, the sphygmomanometer and the balloon pump through a
T-shape connector, as shown below.
2. Zero the transducer. Then open the stopcock to the sphygmomanometer.
3. Press the Main menu button on the equipments front panel. Select [Others>>]
[Installation Mode>>] enter the required password[Maintain IBP]. Then
configure IBP calibration value.
4. Inflate using the balloon pump until the reading of sphygmomanometer approximates
the preset calibration value.
Pressure transducer
3-way stopcock
IBP Module
Sphygmomanometer
5. Adjust the calibration value in the [Maintain IBP] menu until it is equal to the reading
of sphygmomanometer
6. Select the [Calibrate] button to start a calibration
7. The message [Calibration Completed!] is displayed after a successful calibration. If
the calibration failed, the prompt [Calibration Failed!] will be displayed.
4-16
4.6.6 SpO2 Test
Test tool
Patient simulator.
4-17
4.7 Analogue Output Test
Test tool:
Oscillograph
1. Connect the patient simulator to the equipment under test using an ECG or IBP cable.
2. Connect the oscillograph to the equipments multifunctional connector.
3. Verify that the waveforms displayed on the oscillograph is identical with those
displayed on the defibrillator/ monitor.
1. Print ECG waveforms. The recorder should print correctly and the printout should be
clear.
2. Simulate some recorder problems, such as out of paper, paper jam, etc. the defibrillator/
monitor should give corresponding prompt messages. After the problem is removed, the
recorder should be able to work correctly.
3. Switch automatic alarm recording for each parameter ON and then set each parameters
limit outside set alarm limits. Corresponding alarm recordings should be triggered when
parameter alarms occur.
4-18
4.10.2 Accessing Service Mode Menu
To access the factory service menu, Press the Main menu button on the equipments front
panel. Select [Others>>] [Service Mode>>] enter the required passwords. The Service
Mode-Main menu is shown below.
4-19
4. Verify that the reading of RT Imped is between 3000450.
NOTE
z If 300 ohms test load is not available, you can use a 50 ohms test load to perform
impedance checking. In this case, Verify that the reading of RT Imped is
between 50075.
4-20
4.10.5 Device Information
Press the Main menu button on the equipments front panel. Select [Others>>] [Service
Mode>>] enter the required passwords [Device Information]. In the Device
Information list, you can view the device information such as software version, system status,
and etc, as shown below.
In the Device Information screen, you can select [Export] to export error codes and shock
delivery data to a USB flash memory.
Refer to 6.8 Error Codes for the description of each error code.
4-21
4.10.7 Inputting Serial Number
Press the Main Menu button on the equipments front panel. Select [Others>>] [Service
Mode>>] enter the required passwords [Input Serial Number] to input the equipments
serial number.
After inputting the serial number, you can view it by accessing Installation Mode and select
[Version].
4-22
Test Report
Customer name
Customer address
Servicing person
Servicing company
Model of EUT
SN of EUT
Hardware version
Software version
4-23
Test results
Test items Test records
(Pass/Failed)
Visual inspection
The case, display screen, buttons, knob, modules, power cord, and
accessories have no obvious signs of damage.
The external connecting cables are not frayed and the connector pins
are not loose and bent.
The external connectors are not loose or their pins are not bent.
The safety labels and data plate are clearly legible.
Power-on test
The power-on test is passed. The power indicator and alarm system
work correctly and the equipment start up properly.
Performance test
When running on fully charged battery and external paddles are used,
the equipment can be properly charged and discharged; the energy
delivered meets accuracy requirement, and shock information is
correctly recorded.
When external paddles are used, charge tone is correctly issued when
the equipment is being charged. The prompt "Charged Removed" is
shown on the screen and charge done tone stops when the Disarm
hotkey is pressed. The equipment does not discharge externally.
When [Time to Auto Disarm] is set to [60s], the prompt "Charged
Removed" is shown on the screen and the charge done tone stops
after 60 seconds at the completion of charging. The equipment does
not discharge externally.
When pads are used, the charge tone is correctly issued when the
equipment is being charged. The prompt "Charged Removed" is
4-24
Test results
Test items Test records
(Pass/Failed)
shown on the screen and the charge done tone stops when the Disarm
hotkey is pressed. The equipment does not discharge externally.
When [Time to Auto Disarm] is set to [60s], the prompt "Charged
Removed" is shown on the screen and the charge done tone stops
after 60 seconds at the completion of charging. The equipment does
not discharge externally.
When pads are used for synchronous defibrillation and ECG source
is paddles and lead II respectively, the prompt is correct and a Sync
mark appears above each R wave. The delivered energy measured is
10J2J and the synchronous shock is delivered within 60 ms of the
peak of the R-wave.
Pacing Test
ECG waves are displayed correctly without noise and the HR value
is within 801 bpm.
ECG Lead Off alarm behaves correctly.
Paced signals are detected and pace pulse marks are displayed when
[Paced] is set to [Yes]
The difference between the amplitude of the ECG calibration square
wave and that of the wave scale is not greater than 5%.
Resp test
Resp wave is not distorted and the Resp value is within 402 rpm.
NIBP test
4-25
Test results
Test items Test records
(Pass/Failed)
not exceed 6mmHg/min.
Temp test
The value displayed for each Temp channel of the monitor is within
370.1C.
IBP test
The static pressure value displayed for each IBP channel is within
2002 mmHg.
The ART and LV waves for each IBP channel are displayed correctly.
SpO2 test
Recorder check
The recorder can print ECG waves correctly and the printout is clear.
Set the recorder to some problems such as out of paper, paper jam,
etc. the equipment gives corresponding prompt messages. After the
problem is removed, the recorder is able to work correctly.
Automatic alarm recording for each parameter functions correctly
when parameter alarms occur.
4-26
5 Hardware and Software Upgrade
5.1 Hardware Upgrade
After upgrade the hardware, please upgrade corresponding software.
5-1
Upgrading MPM module configured with 3/5-leadECG/NIBP
You can upgrade MPM module from 3/5-lead ECG/NIBP to any of the following
configuration:
5-2
Upgrading MPM module configured with3/5-lead ECG/Masimo SpO2
You can upgrade MPM module from 3/5-lead ECG/Masimo SpO2 to any of the following
configuration:
5-3
Upgrading MPM module configured with 3/5-lead ECG/Mindray
SpO2/NIBP/TEMP
You can upgrade MPM module from 3/5-lead ECG/Mindray SpO2/NIBP/TEM to any of the
following configuration:
5-4
Upgrading MPM module configured with 3/5-lead ECG/ Masimo
SpO2/NIBP/IBP/TEMP
You can upgrade MPM module from 3/5-lead ECG/ Masimo SpO2/NIBP/IBP/TEMP to any
of the following configuration:
NOTE
z If you need to upgrade 3/5-lead ECG to 12-lead ECG, insert the 12-lead ECG
board into the MPM module. Make sure that the 12-lead ECG board should be in
correct direction. Then fix the clip in place.
5-5
Clip 2 Clip 1
Masimo label
No Implied License label
If the upgraded MPM module is equipped with Nellcor SpO2, you need to stick a
Nellcor label at the lower left corner of the front housing, as indicated in the
following pictures.
Nellcor label
5-6
5.1.3 Upgrade the Therapy Module
You can use 801-0652-00039-00 pacer function upgrade kit to upgrade the therapy module so
that equipment has pacing function. After upgrading the therapy module, choose Mode label
(with pacing function) with the language you need.
Mode label
6. After upgrade the therapy module, perform the tests described in 4.6 Module
Performance Tests.
5-7
5.1.4 Upgrade the Equipment with CO2 Module
You can use the following CO2 upgrade package to upgrade the equipment so as to have a
CO2 monitoring function.
4. Apply the CO2 insulating sheet on the MPM module mounting plate. Be careful to align
the edge of insulating plate with the edge of the metal plate when stick the insulating
plate to the metal sheet. Do not stick the screw holes on the metal sheet. Then bent the
insulating plate properly to avoid being cut by the insulating plate during later assembly
process.
5-8
CO2
insulating plate
Bent here
5. Peel off the overlay on the parameter module panel and install the connector fixing part
of the microstream CO2 module or the watertrap receptacle kit and the gas outlet of the
Mindray CO2 module on the parameter module panel. Choose an appropriate overlay
from the upgrade package and apply it on the parameter module panel.
Gas outlet
6. Install the left capacitor metal sheet with CO2 module in the machine.
7. Reassemble the machine. Route the gas pipes to avoid blocking them.
8. Perform the tests as described in 4.2.3 CO2 Module Tests.
5-9
5.1.5 Upgrade the Recorder
You can use the TR8A recorder upgrade package (FRU) (801-0651-00133-00) to upgrade the
recorder from TR6F to TR8A.
5-10
5.2.1 Installing Mindray Patient Monitor Software Upgrade Tool
1. Find the installation program and double click it to start
installation.
2. Select installation language.
3. Click [Ok] and the following screen appears. Click [Next] to go to the next step.
5. Specify the destination folder for installing this program. Then select [Next].
5-11
6. Select Program Folder. Then select [Next].
5-12
5.2.2 Software Upgrade Procedure
1. Connect the defibrillator/monitor to be upgraded with a PC.
2. Set IP address to 77.77.XX.XX and subnet mask to 255.255.255.0.
3. Run Mindray Patient Monitor Software Upgrade Tool on the PC and set Machine to
BneneHeart.
4. On the Mindray Patient Monitor Software Upgrade Tool screen, select [Select Package]
and select packages you want to upgrade. Then select [Start].
5. Simultaneously hold the [Summary] key and [Menu] key on the defibrillator/monitors
front panel, and then turn on the equipment.
After software upgrade is finished, turn off the equipment, and then disconnect AC mains and
remove the battery. If you do not disconnect the power supply after software upgrade, the
status indicator will flash and the beeper will sound.
For the details of software upgrade, refer to help and instructions for use of Mindray Patient
Monitor Software Upgrade Tool.
CAUTION
z Disconnect the equipment from the patient and make sure the important data are
saved before upgrade.
z Do not shut down or power off the equipment when upgrading the boot program.
Otherwise, it may cause the equipment to break down.
z Program upgrade should be performed by qualified service personnel only.
z Crossover network cable shall be used if a PC is connected for equipment upgrade.
NOTE
z After upgrading the boot program, re-upgrade the system program and other
programs to ensure compatibility.
z Make sure the version of the upgrade package is the one that you desired. If you
want to obtain the latest upgrade package, contact Mindray Customer Service
Department.
5-13
5.3 Software Upgrade through a USB Memory
You can upgrade the defibrillator/monitors system software and module software using a
USB memory. All software that can be upgraded through a PC can be upgraded through a
USB memory.
5.3.1 Precautions
1. Software upgrade through USB memory is only applied to defibrillator/monitors with
BIOS version 2.0 or later.
2. If you are going to upgrade the software through a PC, do not plug a USB memory to
the defibrillator/monitors USB connector.
3. Up to 15 upgrade files can be placed to the UPGRADE_0651 folder. If more files are
placed, only the first 15 can be displayed and chosen.
4. Only one upgrade file can be chosen at a time. Repeat steps 3 to 5 as described in 5.3.2
Software Upgrade Procedure to upgrade files one by one.
5. The name of files in directory UPGRADE_0651 should be in English. Otherwise the
file name will be unreadable.
6. Both .pkg and .mpkg files can be upgraded. Bootstrap cannot be included in the .mpkg
files.
7. The bootstrap of main control should be upgrade separately. That is to say, it cannot be
included in the upgrade package.
5-14
6 Troubleshooting
6.1 Overview
In this chapter, the defibrillator/monitor problems are listed along with possible causes and
recommended corrective actions. Refer to the tables to check the defibrillator/monitor,
identify and eliminate the problems.
The problems we list here are frequently arisen difficulties and the actions we recommend
can correct most problems, but not all of them. For more information on troubleshooting,
contact our Customer Service Department.
6-1
6.4 Checking Device Information
Some troubleshooting may involve software compatibility. Thus it requires you to know your
defibrillator/monitor configuration and software version. For detailed information on version
compatibility, please contact our Customer Service Department.
To identify your software version, press the Menu key on the equipments front panel, and
then select [Others>>][Installation Mode>>]enter the required password [Version].
In the Version screen, you can view system software version and module software version.
You can also press the Menu key on the equipments front panel, and then select
[Others>>][Service Mode>>] enter the required password [Device Information>>]
to check system software version, module software version, and device status .
6-2
6.6 Troubleshooting Guide
6.6.1 Defibrillation Problems
Symptom Possible Cause Corrective Action
Keypad board failure Connect external paddles. Press the
Charge button on the Apex paddle to
start charging. If the Charge button
The equipment
on the paddles works, it indicates the
does not charge
keypad board fails.
by pressing the
2. Replace the keypad board.
Charge button on
the front panel. The Charge button fails to be Disassemble the keypad board to
pressed down effectively due to replace or reshuffle the keypad.
the damaged or dislocated silica
gel keypad.
Paddles not connected properly. Reconnect the paddles.
The equipment Paddles failure. Press the Charge button on the front
cannot be charged panel to check if the equipment can be
by pressing the charged. If yes, the paddles fail.
Charge button on Replace the paddles.
the external Therapy module failure Replace the therapy module.
paddles.
Failure of connection wire to the Replace the connection wire
therapy module.
Charging failed Therapy module failure 1. Restart the equipment to check if the
problem disappears.
2. Replace the therapy module if the
problem persists.
Battery failure. Replace the battery or connect the
The equipment is equipment with external power supply.
charged too
Power management board failure. Replace the power management board.
slowly
Therapy module failure Replace the therapy module.
A shock cannot be Keypad board failure. Connect paddles to charge the
delivered by equipment and deliver a shock. If a
pressing the shock can be delivered, the keypad
Shock button on board is defective. Replace the keypad
the equipments board.
front panel in The Charge Button fails to be Disassemble the keypad board. Replace
Manual Defib pressed down effectively due to or reshuffle the keypad
Mode or AED the failure or dislocated silica gel
Mode. keypad.
6-3
Symptom Possible Cause Corrective Action
Paddles not connected properly. Reconnect the paddles.
Paddles failure. Connect pads cable and test load to
A shock cannot be
charge the equipment and deliver a
delivered by
shock. If a shock can be delivered, the
pressing the
paddles fail. Replace the paddles.
Shock button on
Therapy module failure Replace the therapy module.
the paddles.
Connection wire to the therapy Replace the connection wire.
module broken
The message. Therapy module failure Replace the therapy module.
Disarming
Failed is
displayed.
The equipment Too high or too low patient
can be charged, impedance detected. Ensure good connection between the
but the energy is 1. Pads/paddles are detached from patient and pads/paddles. If the problem
disarmed the patient. persists, replace paddles, pads, or pads
automatically at 2. Pads/paddles failure. cable.
the completion of 3. Pads cable failure.
charging or when Therapy module failure Replace the therapy module.
the equipment is
being discharged.
Defibrillation Defibrillation hardware circuit Replace the therapy module.
malfunction. defective.
Keypad board failure 1. Connect paddles and perform energy
setting.
2. Check if energy level can be
Energy Select
selected. If yes, the keypad board is
buttons on the
defective. Replace the keypad board.
equipment front
The Energy Select Buttons fail to Disassemble the keypad board. Replace
panel do not work.
be pressed down due to the or reshuffle the keypad.
damaged or dislocated silica gel
keypad.
Paddles not connected properly. Reconnect the paddles
Energy Select
Paddles failure. Replace the paddles.
buttons on the
Therapy module failure Replace the therapy module.
paddles do not
Connection wires to the therapy Replace the connection wires.
work
module broken
The message Configuration files not properly Upgrade the configuration files.
Defibrillation upgraded.
malfunction Therapy module failure Replace the therapy module.
presented at
power-on
6-4
6.6.2 Pacing Problems
Symptom Possible Cause Corrective Action
Does not deliver Therapy module failure Replace the therapy module.
correct pacing
current.
Does not deliver Therapy module failure Replace the therapy module.
correct pacing
rate.
Pacer Equip Pacer hardware failure Replace the therapy module.
Malfunction
6-5
6.6.4 Display Problems
Symptom Possible Cause Corrective Action
The LCD screen is Connection cable 1. Check that wires between the display and
blank, but the defective or poorly the keypad board, the backlight board and
defibrillator/monitor connected. the keypad board, the backlight board and
works properly. the display and between the keypad board
and the power management board are
correctly connected.
2. Check that the cables and connectors are
not defective
Backlight inverter Replace the backlight board.
defective
LCD Display failure Replace the display.
Keypad board failure Replace the keypad board.
CPU board failure. Replace the CPU board.
Power management board Replace the power management board.
failure.
Secondary display Cable failure 1. Check that the wires between the display
does not function. and the defibrillator/monitor are correctly
connected.
2. Check that the cables and connectors are
not defective.
CPU board failure. Replace the CPU board.
Power management board Replace the power management board.
failure.
Secondary display Connection cable 1. Check that the wires between the display
displays snows or defective or poorly and the defibrillator/ monitor are correctly
flashing specks connected. connected.
2. Check that the cables and connectors are
not defective.
CPU board failure. Replace the CPU board.
Power management board Replace the power management board.
failure.
Images overlapped or FPGA failure Update or upgrade FPGA
distorted Connection cable 1. Check that the wire between the display
defective or poorly and keypad board is correctly connected.
connected. 2. Check that the cables and connectors are
not defective.
6-6
Symptom Possible Cause Corrective Action
The colour of images Connection cable 1. Check that wires between the display and
deviates from the defective or poorly the keypad board, the backlight board and
standard connected. the keypad board, the backlight board and
configuration. the display and between the keypad board
and the power management board are
correctly connected.
2. Check that the cables and connectors are
not defective.
Display failure Replace the display.
Keypad board failure Replace the keypad board.
CPU board failure. Replace the CPU board.
Power management board Replace the power management board.
failure.
6-7
6.6.6 Button and Knob Problems
Symptom Possible Cause Corrective Action
Buttons do not Connection cable 1. .Check that the wire between the keypad and the
respond. defective or poorly keypad board is properly connected.
connected. 2. Check that that the wire between the keypad
board and the power management board is properly
connected
3. Check if the connection wires and connectors are
defective.
Keypad board Replace the keypad board.
failure
CPU board failure. Replace the CPU board.
Power management Replace the power management board.
board failure.
Mode Select knob Connection cable 1. Check that wires between the knob to keypad
does not respond. defective or poorly board, and between the keypad board and the power
connected. management board are properly connected
2. Check that connecting wires and connectors are
not defective.
Knob failure Replace Mode Select knob.
Keypad board Replace the keypad board.
failure
CPU board failure. Replace the CPU board.
Power management Replace the power management board.
board failure.
Navigation knob Connection cable 1. Check that wires between the knob to keypad
does not respond. defective or poorly board, and between the keypad board and the power
connected. management board are properly connected
2. Check that connection wires and connectors are
not defective.
Knob failure. Replace the navigation knob.
Keypad board Replace the keypad board.
failure
CPU board failure. Replace the CPU board.
Power management Replace the power management board.
board failure.
6-8
6.6.7 Recorder Problems
Symptom Possible Cause Corrective Action
No printout Connection cable 1. Check the wire between the recorder and the
defective or poorly keypad board is connected properly.
connected. 2. Check that connection wires and connectors are not
defective.
Recorder power Check if the power module outputs 5 V DC and 12V
supply failure DC correctly
Recorder failure Replace the recorder
Poor print quality Paper roll not Stop the recorder and re-install the paper roll.
or paper not properly installed
feeding properly Print head dirty 1. Check the thermal print head and the paper roller
for foreign matter.
2. lean the thermal print head with an appropriate
clean solution
Recorder failure Replace recorder
Blank printout Paper-roll installed Reload paper-roll
reversely.
Recorder failure Replace the recorder
6-9
6.6.9 CF Card Problems
Symptom Possible Cause Corrective Action
CF card malfunctions Wrong CF card or Use only INNODISK-manufactured CF
limited memory space storage cards. Those with minimum 1GB
memory space are recommended.
CF card defective Insert a known good CF card into the
defibrillator/monitor. If it works normally,
the original CF card fails.
CF card slot failure Replace the CPU board.
CPU board failure. Replace the CPU board.
CF card failure Format the CF card.
Data and fax service is not Verify that data and fax service is
activated. activated.
Y cable and wireless Check that Y cable and wireless
transmission module are not transmission module are connected with the
connected with the unit. unit properly.
Antenna is loose. Tighten the antenna.
Fax machine failure Check that the fax machine works properly.
Wireless transmission Replace the wireless transmission module.
module failure
Y cable failure Replace the Y cable.
Power management board Replace the power management board.
failure
6-10
6.6.11 Power Supply Problems
Symptom Possible Cause Corrective Action
Battery failure Battery damaged. Replace battery.
Battery interface failure. 1. Check batteries are installed properly.
2. Check if the battery interface is defective.
3. If the battery interface is defective,
replace the power management board.
Power management Replace the power management board.
board failure.
Batteries can not be Battery damaged. Replace batteries.
fully charged. Battery interface failure. 1. Check batteries are installed properly.
2. Check if the battery interface is defective.
3. If the battery interface is defective, replace
the power management board.
Power management Replace the power management board.
board failure.
Battery cannot be Battery failure. Replace battery and recharge the replacement
charged battery. If the replacement battery can be
recharged, the original one fails.
Cable defective or Check batteries are installed properly.
poorly connected 2. Check if the battery interface is defective.
3. If the battery interface is defective, replace
the power management board.
Power management Replace the power management board.
board failure.
No +3.3 V A output 1. Power supply failure 1. Turn off the defibrillator/monitor then
No +3.3 V B output 2. Power management restart it.
board failure. 2. If the problem remains, disconnect the AC
Not +5.0 V output
mains for 5 s and reconnect it, then restart
No +12 V output the defibrillator/ monitor.
3. If the problem still remains, replace the
power management board
NOTE
z When the power module has a failure, it may cause problems to other components,
e.g. the defibrillator/monitor suddenly breaks down during start-up, as the power
module may have a power supply protection. In this case, troubleshoot the power
module per the procedure described in the table above.
z Components of the main unit, SMR and parameter modules are powered by the
power module. In the event that a component malfunctions, check if the operating
voltage is correct. Refer to Chapter2 Theory of Operation for the operating voltage
and measurement points of each component.
6-11
6.6.12 Software Upgrade Problems
6-12
6.8 Error Codes
6.8.1 Therapy Module Error Codes
Error codes Error description
0 No error
1 MCU register selftest error
2 MCU RAM selftest error
3 MCU FLASH selftest error
4 MCU watchdog selftest error
5 MCU ADC selftest error
6 DSP register selftest error
7 DSP RAM selftest error
8 DSP FLASH selftest error
9 DSP watchdog selftest error
10 ECG hardware selftest error
11 Power selftest error
12 MCU abnormal reset
13 DSP abnormal reset
14 Computation selftest error
15 to 20 Reserved
21 Impedance circuit error
22 Impedance zeroing failed
23 Impedance calibration failed
24 Impedance measurement is interfered
25 Great measurement difference between two impedance measuring
methods
26 to 30 Reserved
31 Charging is not complete after 25 s
32 Charging is not complete after 30 s
33 Over-charging
34 Charging trend error
35 to 40 Reserved
41 Self-discharging failure
42 IGBT failure
43 Defibrillation relay failure
6-13
Error codes Error description
44 Abnormal discharging current
45 to 70 Reserved
71 Abnormal pacer power
72 Pacer relay failure
73 Pacer frequency error
74 Abnormal pacer current
75 Pacer DA error
76 Pacer voltage error
77 Pacer overcurrent protection point high
78 Pacer overcurrent protection failure
79 to 90 Reserved
91 Comm is interfered (data error)
92 to 99 Reserved
6-14
6.8.3 Main Control Error Codes
Error codes Error contents
200 Fan not connected
201 Speaker not connected
202 Storage card does not exist
203 Power board comm error
204 Therapy module comm error
205/register value Main control system power-on selftest error
206 Realtime clock error
207 Storage card read/write error
208 Button board comm error
209 Machine type recognition error
210 Recorder failure (not including thermal printing head overheat)
211 to 299 Reserved
6-15
Error codes Error contents
316 ECG channel 1 failure
317 ECG channel 2 failure
318 ECG channel 3 failure
319 ECG channel 4 failure
320 ECG channel 5 failure
321 ECG channel 6 failure
322 ECG channel 7 failure
323 ECG channel 8 failure
324 Mindray SpO2 board CPU failure
325 Mindray SpO2 board RAM failure
326 Mindray SpO2 board ROM failure
327 Mindray SpO2 board A/D failure
328 Mindray SpO2 board watchdog failure
329 NIBP selftest failure (2)
330 NIBP system error (15)
331 to 399 For future use
6-16
7 Disassembly and Repair
7.1 Tools Required
To disassemble and replace the parts and components, the following tools may be required:
Phillips screwdrivers
Tweezers
Sharp nose pliers
7# Socket wrench
Adjustable spanner
7-1
7.2 Preparations for Disassembly
Before disassembling the equipment, finish the following preparations:
Stop patient monitoring and therapy, turn off the equipment and disconnect all the
accessories and peripheral devices.
Disconnect the AC power source and remove both batteries.
To avoid high voltage hazard, strictly follow the procedure as defined in section 7.3.6
Discharging the Capacitor for disassembling.
WARNING
z 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.
z Properly connect and route the cables and wires when reassembling the equipment
to avoid short circuit.
z 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.
z Follow correct sequence to disassembly the equipment. Otherwise, the equipment
may be damaged permanently.
z Disconnect all the cables before disassembling any parts. Be careful not to damage
any cables or connectors.
z Place removed screws and disassembled parts properly, preventing them from
being lost or contaminated.
z Place the screws and parts from the same module together to facilitate
reassembling.
z To reassemble the equipment, first assemble the assemblies, and then the main
unit. Carefully route the cables.
z Make sure that the waterproof material is properly applied during reassembling.
7-2
7.3 Disassembling the Main Unit
WARNING
z To disassemble the equipment, first remove the external assemblies, such as the
hook mount, wireless transmission module,paddle tray and front housing, and then
the internal assemblies and parts.
z The power supply assembly and recorder can be removed without removing any
other assemblies.
z To disassemble the equipment, place the equipment on a work surface free from
foreign material, avoiding damaging the antiglare screen, LCD and the knob. Be
careful not to break the two cotters on the front ends of rear housing.
z All the operations should be performed by qualified service personnel only. Make
sure to put on the insulating gloves during service operations.
z Before remove the therapy module high-voltage board, you must use the dicharge
fixture to discharge the capacitor first. If you do not have a discharge fixture,
disconnect AC mains and remove batteries, Wait for at least 2 hours before
removing the capacitor.
7-3
7.3.2 Removing Paddle Tray
1. Stand the equipment on the work surface with the back of the equipment facing to you.
Tweeze the five plastic plugs in the screw holes.
2. Loose and remove the five M310 Philips screws. Remove the paddle tray.
3. Make sure that the waterproof strip is properly applied when replacing the paddle tray in
the equipment.
Waterproof strip on
the top of rear case
7-4
7.3.3 Separating the Housing
1. Lay the equipment on a padded work surface with the display facing down and the
bottom of the equipment nearest to you. Be careful not to damage the LCD and controls.
Loose and remove the 7 M310 Philips screws.
2. Stand the equipment on the work surface. Carefully separate the front housing and the
rear housing. Disconnect the cable between the CPU board and keypad board, and then
remove the front housing.
3. Make sure that the waterproof strip is properly applied when reassemble the front
housing.
Cotter
7-5
7.3.4 Removing the Measurement Module Panel
1. Stand the equipment on the work surface. Loose and remove the M36 Philips screw
that secures the flexible cable. You can also disconnect the flexible cable by loosening
the plastic nut behind the SpO2 board. Remove the flexible cable.
2. Remove the frame that fastens the measurement module panel.
Fastening
frame
Flexible cable
M36 Philips
screws
3. If you equipment is configured with a NIBP module, disconnect the NIBP air tube. If
you equipment is configured with a CO2 module, disconnect the cables between the
CO2 module and the module connector.
If Mindray CO2 module is configured, disconnect the Nafion tube, CO2 exhaust
tube, micro-active switch connector and flow limit tube.
If the microstream CO2 module is configured, disconnect the CO2 exhaust tube
and remove the CO2 connector assembly. If the connector assembly is difficult to
be removed, disconnect the air tube and cable on it. Take care not to damage the air
tube and cables. Remove the measurement module panel.
Mindray CO2 module
Nafion tube
7-6
Microstream CO2 module
Microstream
CO2 connector
NOTE
z Be careful not to damage the air tube when disconnecting the air tube or the cable
between the CO2 module and the module connector. During reassembly, route the
air tube and cable so that they are placed between the MPM module and CO2
module, making sure not to block the air tube.
z When replacing the measurement module panel, do not screw the flexible cable
forcibly avoiding screw slipping. In case the screw slips, fasten the plastic bolt with
the nut before screwing.
z When the equipment is reassembled, make sure that the frame securing the
measurement module panel does not bend the two cotters on the rear housing.
7-7
7.3.5 Removing the Power Supply Assembly
1. Lay the equipment on a padded work surface with the display side facing down and the
bottom of the equipment nearest to you. Be careful not to break the two cotters in the
front of rear housing. Loose and remove the two M38 Philips screws and pull out the
power supply assembly.
M38 Philips
screws
2. Disconnect the cable between the power management board and AC/DC module.
Remove the Power Supply Assembly.
7-8
7.3.6 Discharging the Capacitor
WARNING
z Before removing the capacitor, you must wear insulation gloves which stand high
voltage.
1. Use the high-voltage discharge fixture (0651-TF11) to disarm the capacitor by hooking
the high-voltage ground (TP1) with the black probe of the fixture, and hooking the
high-voltage socket (TP3) with the fixtures red probe. Wait till the indicating lamp on
the fixture turns off. The capacitor is not completely discharged if the indicator remains
on.
2. Set the multimeter to DC 1000V. Measure the discharge resistance to check if the
reading of the multimeter is lower than 30V. If yes, you can safely disassemble the
equipment now.
TP1 TP3
7-9
7.3.7 Removing the Therapy Module High-voltage Board
1. Disconnect the cables from the therapy port and the capacitor.
2. Loose and remove the six M48 Philips screws. Remove the therapy module
high-voltage board.
High-voltag
M48 e board
Philips screw
WARNING
z Before remove the therapy module high-voltage board, you must use the dicharge
fixture to discharge the capacitor first. If you do not have a discharge fixture,
disconnect AC mains and remove batteries, Wait for at least 2 hours before
removing the capacitor.
NOTE
z When replacing the therapy module low-voltage and high-voltage boards, carefully
route the cable to the therapy port so that it comes out through the gaps of PBCAs
and insulation sheet. Make sure the cable is not pressed by the PCBAs.
z Route the cables, making sure that the cables are placed in the gaps between the
PCBAs.
z When connecting two PCBAs, align the connectors and make sure they are firmly
engaged.
7-10
7.3.8 Disassembling the MPM Module
1. Stand the equipment on the work surface, and remove the four M48 Philips screws. If
your MPM module has a fan on it, first disconnect the fan cable, and then remove the
four M48 Philips screws.
M48
Philips screws
2. Disconnect the MPM cable and remove the MPM module assembly.
MPM module
assembly
MPM cable
7-11
7.3.9 Removing the CO2 Module
1. Stand the equipment. Remove the 2 screws integrated with the left capacitor sheet metal
and the two M38 Philips screws. Remove the sheet metal and the CO2 module, if it is
configured. Remove the left capacitor.
Screws integra
ted with the
sheet metal
Left capacitor
sheet metal
M3X8 Philips
screws
For replacement,
place the magnetic
ring in the gap
between PCBAs
and rear case
7-12
3. Remove the 4 M36 Philips screws. Separate the CPU board and power management
board.
M36 Philips
screws
CPU board
NOTE
z To reassemble the CPU board assembly, pass the cable between the power
management board and AC/DC module through the gap on the rear housing; then
replace the CPU board assembly.
z Carefully route the therapy port cable so that it comes out through the gap of
PBCA. Be careful not to press the cable under the PCBA. Make sure the magnetic
ring is fixed at the gap of the CPU board and rear housing.
7-13
7.3.12 Checking Waterproof Material on the Rear Housing
Before reassembling the equipment, make sure that the waterproof material on the rear
housing are stuck to the proper places.
1. Check that the battery elastic pad and the silicone pad are stuck in place.
Silicone
pads. Apply
Battery
glue here
elastic pad
before close
the rear case.
2. Check that power supply waterproof pads 1, 2 and 3 are stuck in place.
Power supply
waterproof pad 3
3. Check that the white waterproof strip is adhered to the proper place.
White waterproof
strip (45 cm long)
7-14
7.4 Disassembling the Front Housing Assembly
NOTE
z To disassemble the equipment, place the equipment on a work surface free from
foreign material, avoiding damaging the antiglare screen, LCD and the knobs.
z After repairing any other front housing assembly, verify that the speaker is not
damaged by powering on the equipment and testing the speaker.
z Clear the LCD before replace it.
Front housing
metal sheet
M38
Philips screws
7-15
2. Disconnect all the cables. Before disconnecting the rotary encoder cable, remove the
hot-melt glue using the sharp nose pliers.
When reassembling,
apply hot-melt glue to
the cable connector
Encoder cable
3. Remove the eight M38 Philips screws and remove the keypad board.
M38
Philips screws
NOTE
z When reassembling the equipment, apply hot-melt glue to the rotary encoders
cable connector to help fastening the cable. Be careful not to damage the cables and
connectors when plugging and unplugging the cables. Properly route the cables
7-16
7.4.2 Removing Display Assembly
1. Disconnect the cables from the alarm lamp board and the indicating lamp board. Your
equipment may be configured with a Toshiba LCD, or Sharp LCD, or AU LCD.
Alarm lamp
board cable
Mode
Select knob
AU LCD
7-17
2. Remove the display assembly from the front housing, Remove the LCD from the shield;
disconnect the cables; remove the LCD inverter.
AU LCD
AU LCD
backlight board
Magnetic ring
between the inverter
and keypad board
LCD
NOTE
z If Sharp LCD is configured, S15 on the keypad board should be short (soldering
temperature between 280 and 300 , soldering time no more than 3 seconds), as
shown below. If Toshiba or AU LCD is configured, the S15 should be open.
7-18
Sharp LCD:
S15 is short
3. Disconnect the cables and separate the LCD from the rubber frame.
NOTE
z Be careful not to damage the rubber frame. Properly route the cables.
z Protect the antiglare screen, LCD and the rotary knob from being scratched.
z When reassembling the equipment, apply hot-melt glue to the displays cable
connector to help fastening the cable.
7-19
7.4.3 Removing the Speaker
1. Remove the two M38 Philips screws. Take off the speaker bracket, and then remove
the speaker.
2. After repairing any other front housing assembly, verify that the speaker is not damaged
by powering on the equipment and testing the speaker.
M38 Philips
screws.
Board
To remove the alarm lamp board and indicating lamp board, remove the three M38 Philips
screws. Then you can remove the alarm lamp shade and indicating lamp shade.
Alarm lamp
Apply glue (DP-10
shade
M38 Philips 5) at the snaps
screws
7-20
7.4.5 Removing the Mode Select Knob
1. Use a sharp nose pliers to pull the Mode Select knob off its shaft. Loosen and remove
the nut and washer using a socket wrench. Disconnect the cable from the knob.
Knob
cable
Washer
and nut
with the
knob
NOTE
z When replacing the Mode Select knob, check that it is aligned with the labeling.
Adjusting the knob using sharp nose pliers if necessary.
7-21
7.4.6 Removing the Rotary Encoder
1. Pull the encoder off its shaft. Loosen and remove the nut and washer using a socket
wrench. Disconnect the encoder cable.
Encoder
cable
Washer and
nut with the
encoder
Rotary
encoder
Recorder
cable
M36 Philips
screws
7-22
7.5 Disassembling the MPM Module
NOTE
z Take care not to damage the plastic bolts and nuts when disassembling and
replacing the PCBAs of the MPM module.
z The MPM module can be flexibly configured according to the customers
requirements. Make sure correct PCBAs are used when reassembling the MPM
module.
M314 Philips
screws with 3
flat washer
NOTE
z The new MPM module does not have a fan. For MPM module which is equipped
with a fan, remember to install the fan during reassembling the MPM module after
maintenance or upgrade.
7-23
7.5.2 Removing the SpO2 board
1. If your equipment is configured with a Masimo SpO2 module, remove the three M314
Philips screws. Thus you can remove the Masimo SpO2 board, Masimo SpO2 adapter
board and Masimo PCBA stacking sleeves.
2. If your equipment is configured with a Nellcor or Mindray SpO2 module, remove the
three M36 Philips screws. Thus you can remove the Nellcor or Mindray SpO2 module.
NOTE
z If 9008 Mindray SpO2 board (051-000058-00) is configured, check SpO2 board
jumper before reassembly. The S3 and S4 should be short, while S5 should be
open. The soldering temperature should be between 280 and 300 , and soldering
time should be no more than 3 seconds
7-24
7.5.3 Removing the MPM Module Analog Board
1. If your equipment is configured with the SpO2 module, remove the three M36 Philips
screws and a M312 plastic bolt. Remove the MPM module analog board.
M312 plastic
bolt M36 Philips
screws
Analog board
2. If your equipment is not configured with the SpO2 module, remove the three M36
Philips screws. Then you can remove the MPM module analog board.
M36 Philips
screws
7-25
7.5.4 Removing the MPM Module Digital Board
1. Remove the 3 M315+6-8 plastic bolt and a M36 Philips screw. If your equipment is
configured with the NIBP module, disconnect the cable and then remove the MPM
module digital board.
M36 Philips
screws
MPM module
M3X15+6-8 digital board
plastic bolt
and insulation
flat washer
Pump
cable
7-26
7.5.5 Removing the NIBP Module
Cut the cable ties. Disconnect the air tubing; remove the pump and airway connector.
Remove the four nuts; then you can remove the NIBP valves shield and the dumping and
linear valves.
NIBP valves
shield
Pump
Airway
connector
7-27
7.6 Disassembling the Power Supply Assembly
7.6.1 Removing the AC/DC board
Remove the seven M36 Philips screws. Disconnect the cable from the AC power input and
remove the AC/DC board.
AC power input
cable
7-28
7.6.2 Removing the Power Supply Sheet Metal and the
Grounding Terminal
1. Remove the M36 Philips screw; disconnect the ground wire. Remove the M6 nut; the
power supply metal sheet; the 6 flat washer and the M6 nut in turn. Then you can
remove the grounding terminal.
Power supply
metal sheet
M6 nut
Ground wire
6 flat washer
+ M6 nut
2. Make sure that the waterproof pad is properly applied when replacing the power supply
module.
Power module
waterproof pad 1
7-29
7.7 Disassembling the CO2 Module
7.7.1 Disassembling the Microstream CO2 Module
1. Remove the six M36 Philips screws, and then remove the microstream CO2 module
and the CO2 adapter board.
Microstream Microstream
CO2 adapter CO2 module
board
Bolt
M3X7+8-6
7-30
7.7.2 Disassembling Mindray CO2 Module
1. Remove the four M36 Philips screws, and then remove the Mindray CO2 module.
Bolt
M3X7+8-6
7-31
7.8 Disassembling the Measurement Module Panel
Assembly
7.8.1 Disassembling the Measurement Module Panel with
Watertrap
Receptacle kit
PT26 crosshead
tapping screw
2. Remove the four PT26 crosshead tapping screws. Thus you can remove the watertrap
bracket.
Watertrap bracket
PT26 crosshead
tapping screw
NOTE
z Make sure the waterproof sheet is properly applied when replacing the CO2
module in the equipment.
7-32
7.8.2 Disassembling the Measurement Module Panel with
Loose the
4 snaps
Microstream
CO2 connector
Waterproof
sheet
CO2 Module
1. Remove the four PT26 crosshead tapping screws, and then remove the CO2
compartment door.
CO2
compartment
door
2. Make sure the waterproof sheet is properly applied when replacing the CO2 module in
the equipment.
Waterproof sheet
7-33
7.9 Disassembling the Recorder
7.9.1 Disassembling the TR6F Recorder
1. Loosen the two snaps and remove the recorder drive board.
Snaps
2. Loosen and remove the two PT26 crosshead tapping screws. Disconnect the flexible
cable and the connection cable between the recorder drive board and recorder keypad
board. Remove the thermal print head and recorder drive board.
Thermal
print head PT26 crosshead
tapping screw
Cable between
Flexible cable the recorder
drive board and
recorder keypad
board
7-34
3. Remove the two PT26 crosshead tapping screws, and then remove the keypad board.
PT26 crosshead
tapping screw
Keypad board
M38 Philips
screws
Recorder drive
board
2. Disconnect the flexible cable and the connection cable between the recorder drive board
and recorder keypad board. Remove the recorder drive board.
7-35
3. Remove the two PT26 crosshead tapping screws; take out the print head.
Print head
PT2.66 crosshead
mounting
tapping screws
plate
4. Remove the two M24 Philips screws and then remove the print head.
5. Remove the two PT26 crosshead tapping screws, and then remove the keypad board.
Keypad board
PT26 crosshead
tapping screws
7-36
7.10 Disassembling the External Paddle
7.10.1 Disassembling the Adult Paddle
Press the latch and slide the adult paddle in the direction as indicated by the following figure
until it is removed.
2. Remove the two PT314 crosshead tapping screws; and then remove the handle cover
and the P+R button.
Be sure to install the waterproof
Apex paddle
strip when reassembling the paddle
cover
Apex paddle
button bracket
2. Remove the PT314 crosshead tapping screw. Take off the button bracket; disconnect
the cable and remove the keypad board.
Sternum paddle
button bracket
7-38
8 Parts
8.1 Introduction
This chapter contains the equipments exploded views and parts lists. It helps the engineer to
identify the parts during disassembling the equipment and replacing the parts. This manual is
based on the maximum configuration. Your equipment may not have some parts and the
quantity of the screws, stacking sleeves, and etc may be different with those included in the
parts lists.
The figure below shows the hardware architecture of the equipments main unit.
Main Unit
External
Front housing Rear housing Paddle tray
paddle set
Handle kit Lithium
Anti-glare screen Power base assembly
battery
Paddle holding Hook mount
8.4" LCD Main board assembly
reed kit
Handle reinforce
Mode Select knob MPM module
sheet metal
Therapy module Paddle sheet
Navigation knob
assembly metal
Recorder Therapy port assembly
Alarm lamp shade CO2 module
Measurement module
Keypad board
panel assembly
Inverter Capacitor assembly
Speaker
Indicating lamp shade
Alarm lamp board
Indicating lamp board
8-1
8.2 Main Unit
8.2.1 Exploded View
8-2
SN P/N Description Qty
8-3
8.3 Front Housing Assembly
8.3.1 Exploded View
8-4
SN P/N Description Qty
area
Silicone keypad (English), monitoring
0651-20-76783-52
area
049-000091-00 Silicone keypad (Spanish)
049-000092-00 Silicone keypad (German)
049-000093-00 Silicone keypad (Polish)
(As configured)
049-000094-00 Silicone keypad (French)
049-000095-00 Silicone keypad (Italian)
049-000097-00 Silicone keypad (Russian)
049-000098-00 Silicone keypad (Brazil Portuguese)
049-000096-00 Silicone keypad (Turkish)
049-000099-00 Silicone keypad (Dutch)
8-5
SN P/N Description Qty
Mode label (D6, English, with pacer
/
function)
Mode label (D6, Chinese, without pacer
/
function)
Mode label (D6, English, without pacer
/
function)
Mode label (D6, Spanish, with pacer
/
function)
Mode label (D6, Spanish, without pacer
/
function)
Mode label (D6, German, with pacer
/
function)
Mode label (D6, Chin German, without
/
pacer function)
Mode label (D6, Polish, with pacer
/
function)
Mode label (D6, Polish, without pacer
/
function)
Mode label (D6, French, with pacer
/
function)
Mode label (D6, French, without pacer
/
function)
Mode label (D6, Italian, with pacer
/
function)
Mode label (D6, Italian, without pacer
/
function)
Mode label (D6, Turkish, with pacer
/
function)
Mode label (D6, Turkish, without pacer
/
function)
Mode label (D6, Russian, with pacer
/
function)
Mode label (D6, Russian, without pacer
/
function)
Mode label (D6, (Brazil Portuguese, with
/
pacer function)
Mode label (D6, (Brazil Portuguese,
/
without pacer function)
Mode label (D6, Dutch, with pacer
/
function)
Mode label (D6, Dutch, without pacer
/
function)
21 / Navigation knob 1
TR6F-30-67306 TR6F recorder 1
22
115-008103-00 TR8A recorder (As configured)
8-6
SN P/N Description Qty
8-7
8.4 Rear Housing Assembly
8.4.1 Exploded View
8-8
SN P/N Description Qty
8 / Power management board insulation sheet 1
9 801-0652-00033-00 Therapy module kit (with pacer) (FRU) 1
801-0652-00034-00 Therapy module kit (no pacer) (As configured)
10 042-005519-00 Right bracket 1
11 / Philips screw, M38 8
12 / Philips screw, M48 10
13 801-0651-00040-00 Capacitor assembly 1
M02B-30-64513 CO2 module (M02B) 1,
14
801-0651-00078-00 Microstream CO2 module (As configured)
801-0651-00009-00 MPM module, without NIBP module
801-0651-00012-00 MPM module (Mindray SpO2 module)
801-0651-00013-00 MPM module (Masimo SpO2 module )
801-0651-00014-00 MPM module (Nellcor SpO2 module )
801-0651-00015-00 MPM module (NIBP)
801-0651-00016-00 MPM module (NIBP/Mindray SpO2) 1
15
801-0651-00017-00 MPM module (NIBP/Masimo SpO2) (As configured)
801-0651-00018-00 MPM module (NIBP/Nellcor SpO2)
801-0651-00116-00 12-lead upgrade kit (FRU)
MPM module, without NIBP module
801-0651-00119-00
(FRU)
801-0651-00120-00 MPM module (Mindray SpO2 module)
Frame for fastening the measurement
16 / 1
module panel
17 / Silicone tube 2
Measurement module panel assembly
801-0651-00019-00
(Mindray SpO2)
Measurement module panel assembly 1
18 801-0651-00020-00
(Masimo SpO2) (As configured)
Measurement module panel assembly
801-0651-00021-00
(Nellcor SpO2)
19 801-0652-00027-00 On-position detection switch 1
8-9
8.5 Rear Housing
8.5.1 Exploded View
8-10
8.5.2 Parts List
SN P/N Description Qty
8-11
8.6 Measurement Module Panel Assembly
8.6.1 Exploded View
8-12
SN P/N Description Qty
8-13
8.7 Power Supply Assembly
8.7.1 Exploded View
8-14
8.7.2 Parts List
SN P/N Description Qty
1 801-0651-00041-00 Power seat (0651) 1
2 / Grounding terminal 1
3 / Lock washer, GB/T862.2-1987 6 1
4 / Power supply metal sheet 1
5 / Hexagon nut, GB/T6172-1986 M6 2
6 / Flat washer, GB97.1 6 1
7 / AC PCB insulation sheet 1
8 / Philips screw, M36 8
9 / AC heat conduction glue 3
10 801-0651-00024-00 AC/DC board (RFU) 1
11 / AC mains label 1
12 / AC plug protection hook 1
13 / AC power input cable 1
14 / Power module waterproof pad 1 2
15 / Power module waterproof pad 2 2
8-15
8.8 MPM Module
8.8.1 Exploded View
8-16
8.8.2 Parts List
SN P/N Description Qty
801-0651-00022-00 MPM module Mindray SpO2 board (FRU)
1
1 801-0651-00088-00 Nellcor SpO2 board (FRU)
(As configured)
0010-10-12275 Masimo M7 Board
801-0651-00002-00 MPM module analog board, Mindray (FRU)
801-0651-00003-00 MPM module analog board, Nellcor (FRU)
1
2 801-0651-00004-00 MPM module analog board, Masimo (FRU)
(As configured)
MPM module analog board,
801-0651-00085-00
Mindray/defibrillator (FRU)
1
2a 801-0651-00023-00 MPM module Masimo SpO2 adapter board (for Masimo
SpO2 board)
MPM module digital board (lead-free process,
801-0651-00001-00
FRU) 1
3
MPM module digital board (lead-free (As configured)
801-0651-00086-00
process/defibrillator, FRU)
4 / Plastic hexagon bolt, M315+6-8 3
5 / Gas pump, P16B07 1
6 / 6800 Fast release valve assembly 1
7 / Insulating plate 1
8 / Philips screw, M316 2
9 / MPM socket cushion 1
10 / MPM module connector fixer 1
11 / MPM module sheet metal 1
12 / 6800 Slow release valve assembly 1
13 / NIBP valves shield 1
14 / Bolt, M316+8-8 3
15 / Hexagon nut and lock washer kit, M3 5
16 / Spring washer 1
17 / Bolt, M314+8-10 1
18 / Philips screw, M36 4
19 / 12-lead ECG board fixer 2 1
20 / 12-lead ECG board 1
21 / 12-lead ECG board fixer 1 1
8-17
8.9 Capacitor Assembly
8.9.1 Exploded View
8-18
8.10 Sidestream CO2 Module Kit
8.10.1 Exploded View
8-19
8.11 Microstream CO2 Module Kit
8.11.1 Exploded View
8-20
8.12 Paddle Tray Assembly
8.12.1 Exploded View
8-21
8.13 External Paddle
8.13.1 Exploded View
8-22
8.14 Sternum Pediatric Paddle Kit
8.14.1 Exploded View
8-23
8.15 Sternum Adult Paddle Kit
8.15.1 Exploded View
8-24
8.16 Apex Pediatric Paddle Kit
8.16.1 Exploded View
8-25
8.17 Apex Adult Paddle Kit
8.17.1 Exploded View
8-26
8.18 External Paddle Cable
8.18.1 Exploded View
8-27
8.19 Hook Mount
8.19.1 Exploded View
8-28
8.20 Replacement Parts
To replace parts, refer to 5 Disassembly and Repair and the explosive views above.
NOTE
z Here we list most replacement parts. If you need more parts, please contact our
Customer Service Department.
Front housing
801-0651-00026-00 Keypad board
0651-20-76783-51 Silicone keypad (Chinese), monitoring area
0651-20-76783-52 Silicone keypad (English), monitoring area
049-000091-00 Silicone keypad (Spanish), monitoring area
049-000092-00 Silicone keypad (German), monitoring area
049-000093-00 Silicone keypad (Porlish), monitoring area
1
049-000094-00 Silicone keypad (French), monitoring area
(As configured)
049-000095-00 Silicone keypad (Italian), monitoring area
049-000097-00 Silicone keypad (Russian), monitoring area
Silicone keypad (Brazil Portuguese), monitoring
049-000098-00
area
049-000096-00 Silicone keypad (Turkish), monitoring area
049-000099-00 Silicone keypad (Dutch), monitoring area
0651-20-76782-51 Silicone keypad, defibrillation 1
801-0000-00002-00 Inverter, DC/AC, 12VDC 500Vrms 6mA 1
801-0000-00007-00 Inverter, DC/AC, 12VDC 600Vrms 6mA 1
801-0651-00111-00 Sharp LCD
801-0651-00110-00 Toshiba LCD 1
801-0651-00138-00 AU LCD (As configured)
801-0651-00044-00 Rotating encoder
801-0651-00043-00 Mode Select knob 1
801-0651-00047-00 Front housing (D6) 1
020-000004-00 Speaker, 8ohm, 1W 40 (dia)*6.8 (hgt) mm 1
8-29
P/N Description Qty
8-30
P/N Description Qty
Parameter interface board assembly
801-0651-00084-00 1
(3/5-lead/mindraySPO2)
801-0651-00042-00 M02B watertrap receptacle assembly 1
9201-30-35923 Microstream CO2 connector fixing assembly 1
801-0651-00041-00 Power seat 1
801-0652-00039-00 Pacer function upgrade kit (no overlay) 1
801-0651-00024-00 AC/DC board (FRU) 1
801-0651-00022-00 MPM module Mindray SpO2 board(FRU) 1
801-0651-00088-00 NELLCOR SpO2 board maintenance kit (FRU) 1
0010-10-12275 MASIMO M7 BOARD(MASIMOKIT) 1
801-0651-00002-00 MPM module analog board (Mindray, FRU) 1
801-0651-00003-00 MPM module analog board (Nellcor, FRU) 1
801-0651-00004-00 MPM module analog board (Masimo, FRU) 1
MPM module analog board (Mindray
801-0651-00085-00 1
defibrillator/monitor PCBA, FRU)
801-0651-00023-00 MPM module Masimo adapting board (FRU) 1
801-0651-00001-00 MPM module digital board (lead-free process, FRU) 1
MPM module digital board (lead-free process,
801-0651-00086-00 1
defibrillator monitor PCBA, FRU)
M02B-30-64513 CO2 main unit (M02B module) 1
9201-30-35908 Microstream CO2 adapting board 1
External paddle
801-0651-00006-00 External paddle (Chinese, FRU)
801-0651-00010-00 External paddle (English, FRU)
801-0651-00101-00 External paddle (Spanish, FRU)
801-0651-00102-00 External paddle (German/French/Dutch, FRU)
1
801-0651-00103-00 External paddle (Polish, FRU)
(As configured)
801-0651-00105-00 External paddle (Italian, FRU)
801-0651-00106-00 External paddle (Turkish, FRU)
801-0651-00107-00 External paddle (Russian, FRU)
801-0651-00108-00 External paddle (Brazil Portuguese, FRU)
Miscellaneous
801-0651-00037-00 Paddle tray assembly 1
022-000012-00 Lithium-ion battery, 14.8V, 4500mAh, LI34I001A 2
801-0651-00005-00 Hook mount kit 1
8-31
P/N Description Qty
8-32
A Electrical Safety Inspection
The following electrical safety tests are recommended as part of a comprehensive preventive
maintenance program. They are a proven means of detecting abnormalities that, if undetected,
could prove dangerous to either the patient or the operator. Additional tests may be required
according to local regulations.
All tests can be performed using commercially available safety analyzer test equipment.
These procedures assume the use of a 601PROXL International Safety Analyzer or equivalent
safety analyzer. Other popular testers complying with IEC 60601-1 used in Europe such as
Fluke, Metron, or Gerb may require modifications to the procedure. Follow the instructions
of the analyzer manufacturer.
The consistent use of a safety analyzer as a routine step in closing a repair or upgrade is
emphasized as a mandatory step if an approved agency status is to be maintained. The safety
analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line
voltage and grounding, as well as total current loads.
A-1
A.2 Device Enclosure and Accessories
A.2.1 Visual Inspection
Test Item Acceptance Criteria
No physical damage to the enclosure and
accessories.
No physical damage to meters, switches,
connectors, etc.
The enclosure and accessories
No residue of fluid spillage (e.g., water, coffee,
chemicals, etc.).
No loose or missing parts (e.g., knobs, dials,
terminals, etc.).
A-2
A.4 Protective Earth Resistance
Protective Earth Resistance is measured using the RED test lead attached to the DUT
Protective Earth terminal or enclosure. Select the test current by pressing SOFT KEY 3 to
toggle between 1AMP, 10AMP, and 25AMP. The front panel outlet power is turned off for
this test.
Preparation
1. First select the test current that will be used for performing the Protective Earth
Resistance test by pressing AMPERES (SOFT KEY 3).
2. Connect the test lead(s) between the RED input jack and the GREEN input jack.
3. Press CAL LEADS. The 601PRO will measure the lead resistance, and if less than 0.150
Ohms, it will store the reading and subtract it from all earth resistance readings taken at
the calibrated current.
If the calibration fails, the previously stored readings will be used until a passing calibration
has occurred.:
WARNING
z During Earth Resistance testing, the DUT must be plugged into the 601PRO
front outlet. If the DUT fails Earth Resistance, discontinue tests and label the
device defective.
A-3
To Perform the Test
1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO
front panel outlet.
2. Attach the 601PRO RED input lead to the devices Protective Earth terminal or an
exposed metal area.
3. Press shortcut key 3. The Protective Earth Resistance test is displayed.
4. Press SOFT KEY 3 to select a test current (1AMP, 10AMP, or 25AMP). The selected
test current is displayed in the upper right corner of the display.
5. Press START TEST to start the test. The test current is applied while resistance and
current readings are taken. This takes approximately 5 seconds.
6. Press the print data key at any time to generate a printout of the latest measurement(s).
NOTE
z When "Over" is displayed for Ohms, this signifies that a valid measurement was
not obtained because either an open connection was detected or that the
measurement was not within range. Readings greater than 9.999 Ohms will be
displayed as Over.
In Case of Failure
Once it reaches the limitation, stop using and inform the Customer Service Engineer for
analysis and disposal.
Limits
R = 0.1 Maximum
A-4
A.5 Earth Leakage Test
Run an Earth Leakage test on the device being tested before performing any other leakage
tests.
There is no need to attach a test lead; the 601PRO automatically connects the measuring
device internally.
SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse.
SOFT KEY 2 toggles the DUT outlet from Earth to No Earth.
SOFT KEY 3 toggles the DUT outlet from L2 to No L2.
SOFT KEY 4 toggles the AP to Earth to No AP to Earth.
4. Press the print data key at any time to generate a printout of the latest measurement.
A-5
In Case of Failure
Check any broken of the enclosure. Replace any defective part.
Inspect wiring for bad crimps, poor connections, or damage.
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
Change another probe to confirm if the fail is caused by console.
Inspect wiring for bad crimps, poor connections, or damage.
If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
Limits
300 A in Normal Condition
1000 A in Single Fault Condition
Preparation
Perform a calibration from the Mains on Applied Part menu.
A-6
WARNING
z If all of the applied parts correspond to the instrument type, the applied parts
will be tied together and one reading will be taken. If any of the applied parts
differ from the instrument type, all applied parts will be tested individually,
based on the type of applied part. This applies to Auto and Step modes only.
4. Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part
leakage current.
5. Modify the configuration of the front panel outlet by pressing the appropriate SOFT
KEY on the 601PRO.
6. Press the print data key at any time to generate a printout of the latest measurement.
NOTE
z If the current test standard being used does not include Patient Leakage DC
readings, or the DC option is not enabled, then DC readings will not be available
through the APPLIED PART SOFT KEY selections. Refer to Chapter 8,
Standards and Principles.
z For external or internal paddle, the patient leakage current test should be tested
when the EUT was charging.
A-7
In Case of Failure
Check any broken of the enclosure. Replace any defective part.
Inspect wiring for bad crimps, poor connections, or damage.
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
Change another probe to confirm if the fail is caused by console.
Inspect wiring for bad crimps, poor connections, or damage.
If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
Limits
For ECG (Defibrillator proof) and other CF applied parts
10 A in Normal Condition
50 A in Single Fault Condition
For BF applied parts
10 A DC,100A AC in Normal Condition
50 A DC,500A AC in Single Fault Condition
A-8
A.7 Mains on Applied Part Leakage
The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage,
through a limiting resistance, to selected applied part terminals. Current measurements are
then taken between the selected applied part and earth. Measurements are taken with the
test voltage (110% of mains) to applied parts in the normal and reverse polarity conditions as
indicated on the display.
The following outlet conditions apply when performing the Mains on Applied Part test.
Normal Polarity;
Reversed Polarity
Preparation
To perform a calibration from the Mains on Applied Part test, press CAL (SOFT KEY 2).
1. Disconnect ALL patient leads, test leads, and DUT outlet connections.
2. Press CAL to begin calibration, as shown:
If the calibration fails, the previously stored readings will be used until a passing
calibration has occurred. Also, the esc/stop key has no effect during calibration.
3. When the calibration is finished, the Mains on Applied Part test will reappear.
WARNING
z A 2-beep-per-second signal indicates high voltage present at the applied part
terminals while a calibration is being performed.
z High voltage is present at applied part terminals while measurements are being
taken.
A-9
To Perform the Test
1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601
2. Attach the applied parts to the 601PRO applied part terminals.
3. Attach the red terminal lead to a conductive part on the DUT enclosure.
4/ Press shortcut key 7. The Mains on Applied Part test is displayed.
5. Select the desired outlet configuration and applied part to test using the appropriate
SOFT KEYS:
6. Press START TEST (SOFT KEY 1) to begin the test.
7. Press the print data key to generate a printout of the latest measurement.
NOTE
z If all of the applied parts correspond to the instrument type, the applied parts
will be tied together and one reading will be taken. If any of the applied parts
differ from the instrument type, all applied parts will be tested individually,
based on the type of applied part. This applies to Auto and Step modes only.
In Case of Failure
Check any broken of the enclosure. Replace any defective part.
Inspect wiring for bad crimps, poor connections, or damage.
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
Change another probe to confirm if the fail is caused by console.
Inspect wiring for bad crimps, poor connections, or damage.
If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
A-10
Limits
For ECG (Defibrillator proof) and other CF applied parts
50 A
For BF applied parts
5000 A
Preparation
1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO
front panel outlet, and turn on the device.
2. Attach the patient leads to the 601PRO ECG jacks.
3. Define the Lead Types from the View Settings Option (refer to: Lead Type Definitions
in Section 5 of this chapter).
4. Press shortcut key 8. The Patient Auxiliary Current test is displayed, and the test begins
immediately. Display values are continuously updated until another test is selected.
A-11
NOTE
z If the current test standard being used does not include Patient Auxiliary
Current DC readings, or the DC option is not enabled, then DC readings will not
be available through the APPLIED PART SOFT KEY selections.
z For external or internal paddle, the patient auxiliary current test should be
tested when the EUT was charging.
In Case of Failure
Check any broken of the enclosure. Replace any defective part.
Inspect wiring for bad crimps, poor connections, or damage.
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
Change another probe to confirm if the fail is caused by console.
Inspect wiring for bad crimps, poor connections, or damage.
If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
Limits
For ECG (defibrillator proof) and other CF applied parts
10A in Normal Condition
50A in Single Fault Condition
For BF applied parts
10A DC,100A AC in Normal Condition
50A DC,500A AC in Single Fault Condition
A-12
ELECTRICAL SAFETY INSPECTION FORM
Overall assessment:
Scheduled inspection: Test item 1, 2, 3, 9
Unopened repair type: Test item 1, 2, 3, 9
Opened repair type, not modify the power board and patient circuit board: Test item 1, 2,
3, 4, 5, 9
Opened repair type, modify the power board or patient circuit board: Test item 1, 2, 3, 4,
5, 6, 7, 8, 9
Location: Technician:
Equipment: Control Number:
Manufacturer: Model: SN:
Measurement equipment /SN Date of Calibration:
INSPECTION AND TESTING Pass/Fail Comments
1 Power Cord Plug
2 Device Enclosure and Accessories
3 Device Labelling
4 Protective Earth Resistance _____ Max 0.1
5 EARTH Normal condition(NC) ____A Max
Leakage Single Fault ____A NC:500A,
condition(SFC) SFC:1000A
6* Patient Normal condition(NC) ____A Max
Leakage Single Fault ____A CF AP
Current condition(SFC) NC:10A, SFC: 50A
BF AP
NC:100A, SFC: 500A
7* Mains on Applied Part Leakage Max
CF AP: 50A
BF AP: 5000A
8* Patient Normal condition(NC) ____A Max
Auxiliary Single Fault ____A CF AP
Current condition(SFC) NC:10A, SFC: 50A
BF AP
NC:100A, SFC: 500A
9 Functional test (parameters tested):
Note: The test items marked * are needed only for incoming inspections and after repairs or
modifications that may have affected lead leakage [NFPA 99 (2005)8.5.2.1.3].
Deficiency / Note:
A-13
FOR YOUR NOTES
A-14
P/N: 0651-20-77084 (8.0)