Passport 12m Patient Monitor Service Manual

Passport 12m Patient Monitor Service Manual
Passport 12m
Patient Monitor
Service Manual
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property
rights to this product and this manual. This manual may refer to information protected by copyrights or patents and
does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any
liability arising out of any infringements of patents or other rights of third parties.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in
this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release,
amendment, reproduction, distribution, rent, adaption and translation of this manual in any manner whatsoever
without the written permission of Mindray is strictly forbidden.
,
, and
are the registered trademarks or trademarks owned by Mindray in China
and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the
intention of improperly using them. They are the property of their respective owners.
Contents of this manual are subject to changes without prior notice.
For this manual, the issued Date is June 2015 (Version2.0).
© 2013-2015 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
WARNING
Federal Law (USA) restricts this device to sale by or on the order of a physician.
NOTE
This manual describes all features and options. The equipment may not have all of them. Contact
Mindray Technical Support department for any questions.
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I
Manufacturer’s Responsibility
Contents of this manual are subject to changes without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein
nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Mindray is responsible for safety, reliability and performance of this product only on the condition that:
All installation operations, expansions, changes, modifications and repairs of this product are conducted by
Mindray authorized personnel;
The electrical installation of the relevant room complies with the applicable national and local requirements;
This product is operated under strict observance of the operator’s manual.
Warranty
Mindray warrants that components within its products will be free from defects in workmanship and materials for a
period of one year from the date of purchase except that disposable or one-time use products are warranted to be free
from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use,
whichever is sooner.
This warranty does not cover consumable items such as, but not limited to, batteries, external cables, and sensors.
Mindray shall not be liable for any incidental, special, or consequential loss, damage, or expense directly or indirectly
arising from the use of its products. Liability under this warranty and the buyer’s exclusive remedy under this warranty is
limited to servicing or replacing the affected products, at Mindray’s option, at the factory or at an authorized distributor,
for any product which shall under normal use and service appear to Mindray to have been defective in material or
workmanship. Recommended preventative maintenance, as prescribed in the service manual, is the responsibility of the
user and is not covered by this warranty.
No agent, employee, or representative of Mindray has any authority to bind Mindray to any affirmation, representation,
or warranty concerning its products, and any affirmation, representation or warranty made by any agent, employee, or
representative shall not be enforceable by buyer or user.
THIS WARRANTY IS EXPRESSLY IN LIEU OF, AND MINDRAY EXPRESSLY DISCLAIMS, ANY OTHER EXPRESS OR IMPLIED
WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A
PARTICULAR PURPOSE, AND OF ANY OTHER OBLIGATION ON THE PART OF MINDRAY.
Damage to any product or parts through misuse, neglect, accident, or by affixing any non-standard accessory
attachments, or by any customer modification voids this warranty. Mindray makes no warranty whatsoever in regard to
trade accessories, such being subject to the warranty of their respective manufacturers.
II
Passport 12m Service Manual
A condition of this warranty is that the equipment or accessories which are claimed to be defective be returned when
authorized, freight prepaid to Mindray DS USA, Inc., 800 MacArthur Blvd, Mahwah, NJ 07430 or its authorized
representative. Mindray shall not have any responsibility in the event of loss or damage in transit.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for
direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the
use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
This warranty does not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure events, such as (i) flood, fire and earthquake or other similar
elements of nature or acts of God; (ii) riots, war, civil disorders, rebellions, or revolutions in any country; or (iii) any
other cause beyond the reasonable control of Mindray.
Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible.
Others not caused by instrument or part itself.
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III
Return Policy
In the event that it becomes necessary to return a unit to Mindray, follow the instructions below.
1.
Obtain a return authorization.
Contact the Mindray Service Department and obtain a Mindray Customer Service Authorization Number. The Mindray
Customer Service Authorization Number must appear on the outside of the shipping container. Return shipments will
not be accepted if the Mindray Customer Service Authorization Number is not clearly visible. Please provide the model
number, serial number, and a brief description of the reason for return.
2.
Freight policy
The customer is responsible for freight charges when this product is shipped to Mindray for service (including any
relevant customs fees or other freight related charges).
3.
Return address
Please send the part(s) or equipment to the address offered by Customer Service Department.
Contact Information
Manufacturer:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen
518057 P.R. China
Tel:
+86 755 81888998
Fax:
+86 755 26582680
Website:
www.mindray.com
Distributor:
Mindray DS USA, Inc.
Address:
800 MacArthur Boulevard, Mahwah, New Jersey 07430 USA
Tel:
1.800.288.2121, 1.201.995.8000
Website:
www.mindray.com
IV
Passport 12m Service Manual
Preface
Manual Purpose
This manual provides detailed information about the assembly, disassembly, 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. Use of the manual is necessary for proper
equipment maintenance and will help to eliminate equipment damage and personal injury.
This manual is based on the maximum configuration; therefore, some contents may not apply to your monitor. If you
have any question, please contact our Customer Service Department.
Intended Audience
This manual is for biomedical engineers, authorized technicians or service representatives responsible for
troubleshooting, repairing and maintaining the patient monitors.
Contact your local Mindray Service Organization for information on product courses which address service and support
for this product.
Passwords
A password may be required to access different modes within the monitor. The passwords are listed below:
User maintenance:
888888 (User adjustable)
Configuration mode:
315666 (User adjustable)
It is recommended that the user should change the passwords for user maintenance and configuration mode once they
take ownership of the equipment.
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V
FOR YOUR NOTES
VI
Passport 12m Service Manual
Contents
1 Safety..............................................................................................................................................................................1-1
1.1 Safety Information.................................................................................................................................................................................... 1-1
1.1.1 DANGER ......................................................................................................................................................................................... 1-2
1.1.2 Warnings ........................................................................................................................................................................................ 1-2
1.1.3 Cautions ......................................................................................................................................................................................... 1-2
1.1.4 Notes ............................................................................................................................................................................................... 1-3
1.2 Equipment Symbols................................................................................................................................................................................. 1-3
2 Theory of Operation ......................................................................................................................................................2-1
2.1 Introduction ............................................................................................................................................................................................... 2-1
2.2 System Connections ................................................................................................................................................................................ 2-1
2.2.1 Mounting the Patient Monitor ................................................................................................................................................ 2-1
2.2.2 Connectors for Peripheral Devices ........................................................................................................................................ 2-2
2.3 Main Unit ..................................................................................................................................................................................................... 2-3
2.3.1 Input System................................................................................................................................................................................. 2-4
2.3.2 Output System ............................................................................................................................................................................. 2-5
2.3.3 Processing and Communications System ........................................................................................................................... 2-7
2.3.4 Power Management System .................................................................................................................................................... 2-8
2.3.5 Equipment Interface System ................................................................................................................................................. 2-11
2.4 Parameter Module .................................................................................................................................................................................. 2-13
2.4.1 Module Infrared Communication Board ............................................................................................................................ 2-13
2.4.2 Module Power Board................................................................................................................................................................ 2-13
2.4.3 Module Button Board .............................................................................................................................................................. 2-13
2.4.4 Parameter Board ........................................................................................................................................................................ 2-13
2.5 SMR ............................................................................................................................................................................................................. 2-14
2.6 BeneLink Module .................................................................................................................................................................................... 2-15
3 Unpacking and Installation ...........................................................................................................................................3-1
3.1 Unpacking and Checking ....................................................................................................................................................................... 3-1
3.2 Preparation for Installation .................................................................................................................................................................... 3-2
3.2.1 Preparation for Installation Site .............................................................................................................................................. 3-2
3.2.2 Environmental Requirements ................................................................................................................................................. 3-2
3.2.3 Electrical Requirements ............................................................................................................................................................ 3-2
3.2.4 Wireless Network Specification............................................................................................................................................... 3-3
3.2.5 Setting up the Wireless Network ............................................................................................................................................ 3-4
3.2.6 Setting the IP Address, Subnet Mask and Gateway .......................................................................................................... 3-4
4 Testing and Maintenance...............................................................................................................................................4-1
4.1 Introduction ............................................................................................................................................................................................... 4-1
4.2 Preventative Maintenance ..................................................................................................................................................................... 4-1
4.2.1 Preventative Maintenance Frequency .................................................................................................................................. 4-1
4.2.2 CO2 Tests......................................................................................................................................................................................... 4-2
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4.2.3 AG Tests........................................................................................................................................................................................... 4-4
4.3 Performance Tests ..................................................................................................................................................................................... 4-7
4.3.1 Performance Test Frequencies................................................................................................................................................. 4-7
4.3.2 Visual Inspection .......................................................................................................................................................................... 4-8
4.3.3 ECG Tests ........................................................................................................................................................................................ 4-9
4.3.4 Resp Performance Test ............................................................................................................................................................... 4-9
4.3.5 SpO2 Test...................................................................................................................................................................................... 4-10
4.3.6 NIBP Tests .................................................................................................................................................................................... 4-10
4.3.7 Temp Test .................................................................................................................................................................................... 4-12
4.3.8 IBP Tests ....................................................................................................................................................................................... 4-12
4.3.9 C.O. Test ....................................................................................................................................................................................... 4-14
4.3.10 CO2 Tests.................................................................................................................................................................................... 4-14
4.3.11 AG Tests ..................................................................................................................................................................................... 4-14
4.3.12 BIS Test ....................................................................................................................................................................................... 4-15
4.3.13 RM Test....................................................................................................................................................................................... 4-15
4.3.14 CCO/SvO2 Tests ........................................................................................................................................................................ 4-16
4.3.15 ScvO2 Tests ............................................................................................................................................................................... 4-16
4.3.16 Nurse Call Relay Performance Test .................................................................................................................................... 4-17
4.3.17 Analog Output Performance Test...................................................................................................................................... 4-17
4.3.18 BeneLink Module Check ...................................................................................................................................................... 4-18
4.4 Electrical Safety and Other Tests ....................................................................................................................................................... 4-23
4.4.1 Electrical Safety and Other Test Frequencies ................................................................................................................... 4-23
4.4.2 Electrical Safety Test................................................................................................................................................................. 4-23
4.4.3 Power On Test ............................................................................................................................................................................ 4-23
4.4.4 Touchscreen Calibration ......................................................................................................................................................... 4-24
4.4.5 Recorder Check ......................................................................................................................................................................... 4-24
4.4.6 Network Print Test .................................................................................................................................................................... 4-24
4.4.7 Battery Check............................................................................................................................................................................. 4-25
4.5 Factory Maintenance ............................................................................................................................................................................ 4-26
4.5.1 Accessing Factory Maintenance Menu .............................................................................................................................. 4-26
4.5.2 Drawing Waves .......................................................................................................................................................................... 4-26
4.5.3 Enabling/Disabling the Recorder ........................................................................................................................................ 4-26
4.5.4 Checking Software Version.................................................................................................................................................... 4-27
4.5.5 Checking Monitor Information............................................................................................................................................. 4-27
5 Troubleshooting ............................................................................................................................................................ 5-1
5.1 Introduction ................................................................................................................................................................................................ 5-1
5.2 Part Replacement ...................................................................................................................................................................................... 5-1
5.3 Patient Monitor Status Check ................................................................................................................................................................ 5-1
5.4 Software Version Check........................................................................................................................................................................... 5-1
5.5 Technical Alarm Check............................................................................................................................................................................. 5-2
5.6 Troubleshooting Guide ........................................................................................................................................................................... 5-2
5.6.1 Power On/Off Failures ................................................................................................................................................................ 5-2
5.6.2 Display Failures............................................................................................................................................................................. 5-2
5.6.3 Module Rack Failures .................................................................................................................................................................. 5-3
5.6.4 Alarm Problems ............................................................................................................................................................................ 5-5
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Passport 12m Service Manual
5.6.5 Button and Knob Failures ......................................................................................................................................................... 5-5
5.6.6 Recorder Failures ......................................................................................................................................................................... 5-6
5.6.7 Output Interface Failures .......................................................................................................................................................... 5-6
5.6.8 CF Card Problems ........................................................................................................................................................................ 5-7
5.6.9 Power Supply Failures ................................................................................................................................................................ 5-7
5.6.10 Wi-Fi Related Problems ........................................................................................................................................................... 5-8
5.6.11 Wired Network Related Problems ...................................................................................................................................... 5-10
5.6.12 Software Upgrade Problems ............................................................................................................................................... 5-10
5.6.13 Technical Alarm Messages ................................................................................................................................................... 5-11
5.6.14 M51A Self Test Information.................................................................................................................................................. 5-11
5.6.15 Device Integration Failures .................................................................................................................................................. 5-11
6 Repair and Disassembly ................................................................................................................................................6-1
6.1 Tools .............................................................................................................................................................................................................. 6-1
6.2 Preparations for Disassembly................................................................................................................................................................ 6-1
6.3 Disassembling Procedure....................................................................................................................................................................... 6-2
6.3.1 Removing the Recorder ............................................................................................................................................................ 6-2
6.3.2 Separating the Front and Rear Housing............................................................................................................................... 6-6
6.3.3 Removing the Power Switch & LED Board ........................................................................................................................... 6-8
6.3.4 Removing the Knob Encoder .................................................................................................................................................. 6-8
6.3.5 Removing the Button Board .................................................................................................................................................... 6-9
6.3.6 Removing the Touchscreen Control Board ....................................................................................................................... 6-10
6.3.7 Removing the Backlight Board ............................................................................................................................................. 6-11
6.3.8 Removing the LCD .................................................................................................................................................................... 6-11
6.3.9 Removing the Alarm Lamp Board........................................................................................................................................ 6-12
6.3.10 Removing the Fan Assembly ............................................................................................................................................... 6-13
6.3.11 Removing Battery Compartment Assembly .................................................................................................................. 6-13
6.3.12 Removing the Integral Module Rack ................................................................................................................................ 6-14
6.3.13 Removing the CF Card Assembly....................................................................................................................................... 6-16
6.3.14 Removing the wireless AP assembly ................................................................................................................................ 6-17
6.3.15 Removing the Main Board ................................................................................................................................................... 6-18
6.3.16 Removing the Speaker .......................................................................................................................................................... 6-21
6.3.17 Removing the Power Module Assembly ......................................................................................................................... 6-21
6.3.18 Removing the Main Support ............................................................................................................................................... 6-23
6.3.19 Removing the Interface Board Assembly ........................................................................................................................ 6-24
6.4 Removing the SMR Assembly ............................................................................................................................................................. 6-26
6.5 Disassembling Modules........................................................................................................................................................................ 6-30
6.5.1 Disassembling the BeneLink Module ................................................................................................................................. 6-30
6.5.2 Disassembling the MPM Module ......................................................................................................................................... 6-35
7 Parts................................................................................................................................................................................7-1
7.1 Introduction ............................................................................................................................................................................................... 7-1
7.2 Main Unit ..................................................................................................................................................................................................... 7-2
7.3 Front housing Assembly ......................................................................................................................................................................... 7-3
7.3.1 12.1” LCD with Touchscreen ..................................................................................................................................................... 7-3
7.3.2 12.1" LCD TFT assembly of PP12m ......................................................................................................................................... 7-4
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3
7.4 Main Unit ..................................................................................................................................................................................................... 7-5
7.4.1 Main Unit Assembly .................................................................................................................................................................... 7-5
7.4.2 Battery Compartment Assembly ............................................................................................................................................ 7-7
7.4.3 Power Module assembly ........................................................................................................................................................... 7-8
7.4.4 Interface Board Assembly (6802-30-66769) ........................................................................................................................ 7-9
7.4.5 Main Board Assembly.............................................................................................................................................................. 7-10
7.4.6 Integral module rack ............................................................................................................................................................... 7-11
7.4.7 Main Support Assembly ......................................................................................................................................................... 7-12
7.4.8 Rear Housing Assembly .......................................................................................................................................................... 7-13
7.4.9 CF Card Assembly(115-001906-00) ..................................................................................................................................... 7-14
7.4.10 Internal Wireless AP Assembly ........................................................................................................................................... 7-15
7.5 SMR ............................................................................................................................................................................................................. 7-16
7.5.1 SMR Assembly ........................................................................................................................................................................... 7-16
7.5.2 SMR Inner Assembly ................................................................................................................................................................ 7-17
7.6 MPM Module ........................................................................................................................................................................................... 7-18
7.7 Replaceable Parts ................................................................................................................................................................................... 7-20
7.7.1 Main Unit..................................................................................................................................................................................... 7-20
7.7.2 SMR ............................................................................................................................................................................................... 7-22
7.7.3 Parameter Modules and Cables ........................................................................................................................................... 7-22
8 Upgrade.......................................................................................................................................................................... 8-1
8.1 Introduction ................................................................................................................................................................................................ 8-1
8.2 Upgrading Parameter Modules ............................................................................................................................................................ 8-2
8.3 Upgrading Functional Assemblies ....................................................................................................................................................... 8-3
8.3.1 Upgrading SMR ............................................................................................................................................................................ 8-3
8.4 Upgrading Software ................................................................................................................................................................................. 8-3
A Electrical Safety Inspection.......................................................................................................................................... A-1
A.1 Power Cord Plug....................................................................................................................................................................................... A-1
A.2 Device Enclosure and Accessories ...................................................................................................................................................... A-1
A.3 Device Labeling........................................................................................................................................................................................ A-2
A.4 Scheduled Electrical Safety Inspection ............................................................................................................................................. A-2
A.5 Electrical Safety Inspection after Repair ........................................................................................................................................... A-2
A.6 ELECTRICAL SAFETY INSPECTION TEST............................................................................................................................................. A-3
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Passport 12m Service Manual
1 Safety
1.1 Safety Information
DANGER
Indicates an imminent hazard that, if not avoided, will result in death or serious injury.
WARNING
Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious
injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury
or product/property damage.
NOTE
Provides application tips or other useful information.
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1-1
1.1.1 DANGER
There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective
sections of this manual.
1.1.2 Warnings
WARNING
All installation operations, expansions, changes, modifications and repairs of this product should be
conducted by Mindray authorized personnel.
There is high voltage inside the equipment. Never disassemble the equipment before it is disconnected
from the AC power source.
When you disassemble/reassemble a parameter module, a patient leakage current test must be
performed before it is used again for monitoring.
The equipment must be connected to a properly installed power outlet with protective earth contacts
only. If the installation does not provide for a protective earth conductor, disconnect it from the power
line and operate it on battery power, if possible.
Dispose of the package material, observing the applicable waste control regulations and keeping it out
of children’s reach.
1.1.3 Cautions
CAUTION
Make sure that no electromagnetic radiation interferes with the performance of the equipment when
preparing to carry out performance tests. Mobile phone, X-ray equipment or MRI devices are a possible
source of interference as they may emit higher levels of electromagnetic radiation.
Before connecting the equipment to the power line, verify the voltage and frequency ratings of the
power line are the same as those indicated on the equipment’s label or in this manual.
Protect the equipment from damage caused by drop, impact, strong vibration or other mechanical force
during servicing.
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Passport 12m Service Manual
1.1.4 Notes
NOTE
Refer to Operation Manual for detailed operation and other information.
1.2 Equipment Symbols
See the Passport 12m/Passport 17m Operator’s Manual for information about the symbols used on this product and its
packaging.
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FOR YOUR NOTES
1-4
Passport 12m Service Manual
2 Theory of Operation
2.1 Introduction
This patient monitor is designed to monitor a fixed set of physiological parameters including ECG, heart rate (HR),
respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure
(NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), oxygen (O2), anesthetic gas (AG),
impedance cardiograph (ICG), bispectral index (BIS), respiration mechanics (RM), and central venous oxygen
saturation (ScvO2).
The patient monitor also:
Provides audible and visual alarm indications in case of patient or equipment problems.
Enables displaying, reviewing, storing and transferring of real-time data.
Incorporates multiple input devices such as buttons, knob, touchscreen, keyboard and mouse.
Interfaces a clinical information system or central monitoring system.
Enables program upgrade over the network.
Integrates the information of other devices, which include but are not restricted to anesthesia machine and
ventilator.
2.2 System Connections
2.2.1 Mounting the Patient Monitor
The patient monitor can be mounted on a wall bracket or on a trolley support. The wall bracket or trolley support can be
ordered separately. Each mounting bracket is delivered with a complete set of mounting hardware and instructions.
CAUTION
Not using screw and bracket specified by Mindray may cause the screw to touch the internal battery
and lead to monitor damage (the proper screw depth should be between 6.5mm and 7.5mm). Take out
the rubber stoppers in the two screw holes of the base when installing the tray.
The mounting bracket should be installed by our qualified service personnel, or qualified personnel
having a full understanding of local building codes.
If a non-validated mounting solution is used, the installation personnel and the customer should verify
this mounting device can safely handle the load of the 12m monitor and peripheral equipment used
with it such as modules, cables, SMR and hoses. Customer assumes all liability if installing mounting
equipment other than that recommended by Mindray.
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2-1
2.2.2 Connectors for Peripheral Devices
On the back of the patient monitor you will find all connectors for peripheral devices.
1.
AC Power Connector: used to connect an AC power source (100 to 240 VAC, 50/60Hz).
2.
Equipotential Terminal: used to connect the equipotential terminal of other equipment, eliminating potential
difference between different pieces of equipment.
3.
Analog Output and Defibrillator Connector: It is a Micro-D connector used to output analog signals and defibrillator
synchronization signals.
4.
CIS Connector: It is used to connect a CIS.
5.
Video Output: It is a DVI-D connector used to connect a secondary display.
6.
Auxilliary Output Connector: It is a BNC connector used to output nurse call signals.
7.
Network Connector: It is a RJ45 connector used to connect an ethernet network or a PC.
8.
USB Connector: used to connect any USB-compatible peripheral device.
9.
SMR Connector: Powered USB connector which is used with the special powered USB cable necessary to connect
and operate the SMR.
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Passport 12m Service Manual
2.3 Main Unit
The patient monitor consists of:
Input system: button board, knob, touchscreen, power switch and LED board
Output system: LCD panel, alarm LED board, recorder and speaker
Processing and communications system: main board and integral module rack assembly.
Power management system: battery, battery interface board and power module
Equipment interface system: USB_Hub interface board, DVI interface board CF card assembly and internal wireless
network card.
Additionally, the patient monitor can also support a satellite module rack (SMR), parameter modules, BeneLink module,
mouse, keyboard, etc.
The following diagram illustrates the structure of the patient monitor
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2-3
2.3.1 Input System
Button board
The button board, located at the lower part of the monitor’s front panel, contains 6 keys and provides connections for
the following components to the main board:
Knob
Power switch & LED board
Touchscreen control board
Alarm LED board
Backlight board
The following diagram shows the button board connections.
Knob
The knob can be pressed, or rotated both clockwise and counter-clockwise. It is connected to the button board.
Touchscreen
The touchscreen enables touch operations and can be calibrated. It is connected to the touchscreen control board and
main board.
Power switch & LED Board
The power switch & LED board controls the power supply for the main unit. It has three LEDs, which respectively indicate
the AC power status, battery status and monitor power on/off status. It is connected to the button board.
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Passport 12m Service Manual
2.3.2 Output System
LCD
The patient monitor utilizes a high-resolution LCD. The LCD is connected to the main board. The signals and power
supply from the backlight board are transferred by the button board.
Alarm Lamp
The patient monitor has two alarm lamps integrated in the alarm lamp board.. Alarm lamps light either red or yellow.
The alarm lamp signals are transferred by the button board and are directly controlled by the main board.
Recorder
The recorder receives data from the main board and transmits it to the thermal print head for printing. The recorder has
a hardkey (start/stop recordings) and a green LED (It is ON during normal working) on its front panel. It is connected to
the mother board.
The following diagram shows its operating principle.
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2-5
Module
Description
Power interface
Introduces DC voltage from the main board.
Recorder power
module
Converts the input A/C power into appropriate D/C voltages which power individual modules.
Recorder CPU
Controls the communications between modules.
Signal interface
Controls the communications between the main board and the recorder CPU.
Motor drive circuit
Receives the control signals from the CPU and then forwards them to the stepper motors
Button & LED board
The button and the LED board are directly controlled by the CPU.
Speaker
The speaker provides sound for alarms, key strokes, heart beats and pulse, and allows PITCH TONE and multi-level tone
modulation. It is connected with the main board and is directly driven by the main board.
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Passport 12m Service Manual
2.3.3 Processing and Communications System
Main Board
The main board is the heart of the patient monitor. It implements a series of tasks including input & output control, data
storage and processing, display processing, system control, communication management, printing management and
alarming, etc.
The main board is comprised of the CPU board and mother board. The following diagram shows interfaces to other
components.
The CPU board consists of the CPU, FLASH, memory, real-time clock, EEPROM, etc. It interfaces to the mother board only,
which then provides interfaces to all other external devices.
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2-7
The mother board controls all connections and communications with other components and provides the following
interfaces:
Name
Description
LCD connector
Connects the built-in display.
Video output +IO +IIC
Connects the digital video interface board.
USB×2+network+RS422 +GPIO port
Connects the USB_Hub board.
Button board connector
Connects the button board.
Recorder connector
Connects the recorder.
CF card connector
Connects the CF card assembly.
Speaker connector
Connects the speaker.
Power module connector
Connects the power module.
Integral module rack connector
Connects the 3-slot rack communication board in the integral module rack.
Fan connector
Connects the fan.
Internal wireless network card
assembly
Connects the internal wireless network card.
Integral Module Rack
The patient monitor has two kinds of integral module racks: 2-slot and 5-slot. The control board includes a NIOS II FPGA.
It implements protocol conversion and infrared communication between the main unit and the parameter modules
The module rack communication board can be a 2-slot type or a 3-slot type. The 3-slot communication board
communicates with the main board directly. The 2-slot communication board is connected to and controlled by the
3-slot communication board. The 3-slot communication board has the function of communication control. The 2-slot
communication board consists of the infrared circuit and module power circuit. The RS422 drive circuit is located on the
3-slot communication board.
2.3.4 Power Management System
Battery
The patient monitor uses two rechargeable lithium-ion batteries (11.1 V, 4500 mAh). The battery compartment is located
at the bottom of the patient monitor. The battery power is supplied to the mother board via the battery interface board,
and then to the power module.
Battery Interface Board
The Battery interface board connects the batteries to the DC input terminal of the power module via the mother board,
implementing charging and discharging of the batteries and the power board.
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Passport 12m Service Manual
Power Module
The power module is located at the back of the patient monitor. The main part of the power module is the power board,
which contains charging & power management board, voltage drop DC transforming board and voltage rise and drop
DC transforming board.
The power module converts the input power into DC and supplies each component of the patient monitor. The input
power comes from either the batteries or an AC source. The patient monitor will run power from the AC source
whenever an AC source is available. If the AC source is not available, the patient monitor will automatically switch to
battery power. This does not affect the monitor’s operating status.
The power module protects itself and the patient monitor by switching off AC input or DC output in case of overcurrent,
short circuit and overvoltage. The power module provides 3 DC outputs:
Outputs
+3.3 VDC
+5.0 VDC
+12 VDC
Description
Power supply of the LCD, mother board, CPU board, DVI interface board and integral module
rack.
Power supply of the DVI interface board, recorder, CF storage card board and USB_Hub
board.
Power supply of the recorder, LCD backlight board, integral module rack, parameter modules,
USB_Hub board。
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The following diagram shows the pins of the power socket connecting the power module and the mother board:
Pin ID
Marking
Description
1/3/5
12V
The positive output of the 12 VDC power
2/4/6/8/10/
GND
The output grounding terminal of the power board.
7/9
3V3
The positive output of the 3.3 VDC power
11
5V
The positive output of the 5 VDC power
12
BC1
Signal indicating whether battery 1 is available. Low level indicates that battery 1 is
27/28/29/30
available and high level indicates that battery 1 is not available.
13/15
BAT+1
Input of battery 1, connecting to the positive pole of the battery.
14
NTC1
Thermistor signal of battery 1.
16
BC2
Signal indicating whether battery 2 is available. Low level indicates that battery 2 is
available and high level indicates that battery 2 is not available.
18
NTC2
Thermistor signal of battery 2.
17/19
BAT+2
Input of battery 2, connecting to the positive pole of the battery.
20
PCON
Power on/off control signal. It is a TTL pulse signal inputted from the back board. Every
time when the power on/off switch is pressed (pulse of falling edge), a switch between
power “on” and “off” happens. The pulse duration is no less than 0.1 s for power on, 2 s for
power off and 10 s for illegal power off.
21
BCON
Backlight on/off signal and switch output signal. The main board sends the LCD
backlight on/off signals to the power board via a serial port, the power board processes
the signals and output them. Low level is output when the backlight is off and high level
is output when the backlight is on.
22
LED-BAT
Battery status indication driving output
23
LED-AC
AC power status indication signal
24
LCD-BR
Backlight brightness control voltage.
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Passport 12m Service Manual
2.3.5 Equipment Interface System
USB_Hub board
The USB_Hub board is connected with the mother board. It is compatible with USB1.1 connectors and supports
equipment hot plug. The UART signal output by the main board is converted into RS422 signal by the USB_HUB board. It
receives 5 VDC and 12 VDC inputs from the power module, of which the 5 VDC is supplied to the USB interface board
and the 12 VDC is outputted to the SMR connector through a fuse.
BNC
RJ 45 connector
USB connector
USB&POWER
connector
A BNC connector used to output nurse call signals.
A standard RJ45 connector, providing 10/100 BASE-TX Ethernet communications channels. It
connects an Ethernet network or a PC.
Connects devices with USB connector.
Provides RS232 and RS422 interfaces for the communication between main board and SMR. It
receives 5 VDC and 12 VDC inputs from the power module, of which the 5 VDC is supplied to the
USB interface board and the 12 VDC is outputted to the SMR connector through a fuse.
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DVI Interface Board
The DVI interface board is connected with the mother board. The following diagram shows its interfaces to other
components.
Interface
Description
DVI connector
Connects the secondary display.
CIS Connector
Connects the CIS system.
Micro-D connector
Outputs analog signals and defibrillator synchronization signals.
CF Card Assembly
The CF assembly serves the non-volatile CF card which is used for data storage and transferring. It is connected with the
mother board.
Internal wireless network card
The internal wireless network card connects with the mother board. User can set network type as LAN or WLAN through
user interface and can set the internal wireless network card through PC.
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2.4 Parameter Module
Each parameter module may consist of the module infrared communication board, module power board, module
button board, parameter board, etc.
2.4.1 Module Infrared Communication Board
The module infrared communication board allows a short delay when powering up the module and adopts FPGA to
enable infrared communications between the module and the module rack. An ID is integrated into the module infrared
communication board. When a module is inserted in the module rack, the ID is automatically sent to the module rack.
2.4.2 Module Power Board
Some modules have no power board. There are two kinds of module power board:
1.
Isolated power board: converts the 12 VDC into a 12 V isolated DC and a 5 V isolated DC.
2.
Non-isolated power board: converts the 12 VDC into a 5 VDC
2.4.3 Module Button Board
There are keys and an LED on the module button board.
2.4.4 Parameter Board
The parameter board is a parameter measurement component.
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2.5 SMR
The satellite module rack (SMR) is independent of the patient monitor. It provides 8 slots for mounting parameter
modules. It has the following features:
It allows a parameter module to be plugged and unplugged with the patient monitor on. This allows function
extension and patient transfer.
The SMR receives 12 VDC through a powered USB cable coming from the 17m monitor. It then then supplies power
to each parameter module via the contact screws.
It implements communication protocol conversions between the patient monitor and each parameter module,
provides infrared communications for parameter modules, and is responsible for detecting infrared
communications malfunction for each parameter module.
The following diagram shows the structure of the SMR.
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Passport 12m Service Manual
2.6 BeneLink Module
The BeneLink module allows the information (patient data, alarms, etc.) from the external device to be displayed, saved,
recorded, printed, or calculated through a Passport 12m patient monitor. If the patient monitor is connected with the
CMS or gateway, information from the external device can also be transmitted to the CMS or gateway. The BeneLink
module connects with the external device through an ID module, which enables the information transmission between
the BeneLink module and the external device. The BeneLink module can be connected to many external devices such as
anesthesia machines and ventilators.
The following diagram shows the structure of the BeneLink module:
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FOR YOUR NOTES
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Passport 12m Service Manual
3 Unpacking and Installation
This chapter provides information you need to install a patient monitor ready for use.
WARNING
The equipment shall be installed by personnel authorized by Mindray.
The software copyright of the equipment is solely owned by Mindray. No organization or individual shall
resort to altering, copying, or exchanging it or to any other infringement on it in any form or by any means
without due permission.
Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g. IEC
60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical
electrical equipment). The system configuration must meet the requirements of the IEC 60601-1-1 medical
electrical systems standard. Any personnel who connect devices to the equipment’s signal input/output
port is responsible for providing evidence that the safety certification of the devices has been performed in
accordance to the IEC 60601-1-1. If you have any question, please contact Mindray.
If it is not evident from the equipment specifications whether a particular combination with other devices is
hazardous, for example, due to summation of leakage currents, please consult the manufacturers or an
expert in the field. A determination must be made that the proposed combination will not negatively affect
the devices themselves or the patient's safety.
3.1 Unpacking and Checking
Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier
or Mindray.
If the packing case is intact, open the package and remove the equipment and accessories carefully. Check all materials
against the packing list and check for any mechanical damage. Contact Mindray in case of any problem.
WARNING
When disposing of the packaging material, be sure to observe the applicable waste control regulations and
keep it out of children’s reach.
The equipment might be contaminated during storage and transport. Before use, please verify whether the
packages are intact, especially the packages of single use accessories. In case of any damage, do not apply it
to patients.
NOTE
Save the packing case and packaging material as they can be used if the equipment must be reshipped.
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3.2 Preparation for Installation
3.2.1 Preparation for Installation Site
1.
Ensure that the site meets all safety, environmental and power requirements
2.
Check that required power sockets are available.
3.
Check that a network connector is available if the monitor needs to be connected to the wired network.
3.2.2 Environmental Requirements
To avoid explosion hazard, do not use the equipment in the presence of flammable anaesthetics, vapors or liquids. The
environment where the monitor will be used should be 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.
Refer to Passport 12m/Passport 17m Patient Monitor Operator’s Manual (PN: 046-005013-00) for the monitor’s
environmental specification
3.2.3 Electrical Requirements
The monitor can be connected to AC power source. Only power sockets with protective grounding can be used. Make
sure that:
1.
All cables and connectors 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.
Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are
the same as those indicated on the equipment’s label or in this manual.
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Passport 12m Service Manual
3.2.4 Wireless Network Specification
Network Standard
IEEE 802.11b/g/n @ 2.4 GHz
IEEE 802.11a/n @ 5 GHz
Modulation Mode
DSSS and OFDM
Device Baud Rate (data
IEEE 802.11a: 6–54 Mbps
rate)
IEEE 802.11g: 1–54 Mbps
IEEE 802.11n: Mcs 0–6
Network Latency
Total delay of Passport 12m transmitting data to the central station: ≤ 2s
Total delay of the Passport 12m transmitting data to other monitors: ≤2s
Output Power
< 30 dBm (FCC requirement: detection mode – peak power)
< 20 dBm (CE requirement: detection mode – RMS)
Operating Mode
Infrastructure
Data Security
WPA2-PSK encryption supported
Data Integrity
Code error rate (UDP Layer) <3%
Priority
All communication data types shall have the same priority
Roaming
Network switchover is automatically implemented when Passport 12m moves from the
coverage area of AP1 to that of AP2
System Capacity
Number of Passport 12m monitors supported by a single AP: ≤ 16.
Each Passport 12m can communicate with the Central Station and connect to two other
monitors at the same time.
When reconnected at the same time, at most two Passport 12m
monitors can transmit history data to the DPM Central Station (the Panorama Central Station
does not support transfer of historical data) simultaneously. The wireless function of all Passport
12m monitors is normal under these conditions.
Susceptibility to wireless
When the distance between interfering devices (including wireless devices at the frequency of
interference
2.4GHz such as cellular mobile communication networks, microwave ovens, interphones,
cordless phones and electro-surgical units, excluding Wi-Fi) and Passport 12m is greater than 20
cm, the wireless functions of Passport 12m are normal.
Network Interruption
When the network is reconnected, wireless connection recovers automatically
FCC Approval
FCC ID: N6C-SDMAN
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3.2.5 Setting up the Wireless Network
The patient monitors can be connected to a wireless network via a built-in Wi-Fi module. To set up the wireless network:
1.
Select [Main Menu]→[Maintenance>>]→[User Maintenance>>]→enter the required password→[Network
Setup >>]→[Monitor Network Setup >>].
2.
Set the [Network Type] to [WLAN].
3.
Configure the [Network Name (SSID)], and [Password].
4.
Click [Ok] to confirm the setting.
To test the availability of the wireless network, follow this procedure:
1.
Select [WLAN Test >>] in the [Monitor Network Setup] menu.
2.
Enter the [IP Address] of the wireless AP in the [WLAN Test >>] menu.
3.
Click [Connection Test].
If the designated IP can be successfully connected, the reply time is displayed. If the connection fails, the reply is
timeout.
The Wi-Fi device used in the monitor is in compliance with IEEE 802.11b/g/n.
3.2.6 Setting the IP Address, Subnet Mask and Gateway
In the [Network Setup >>]→[Monitor Network Setup] menu, you can set the IP address, subnet mask and gateway.
You should not change the patient monitor’s IP address randomly. For the detailed information regarding IP address
setup, contact the technical personnel in charge of the CMS.
NOTE
The design, installation, construction and maintenance of the wireless network shall be performed by
authorized Mindray service personnel.
3-4
Certain obstacles, such as walls, may impact data transmission and possibly cause network interruption.
Passport 12m Service Manual
4 Testing and Maintenance
4.1 Introduction
To ensure the patient monitor always functions properly, qualified service personnel should perform regular
inspections, maintenance and tests. This chapter provides a checklist of the testing procedures for the patient monitor
with recommended test equipment and inspection schedule.
The testing procedures provided in this chapter are intended to verify that the patient monitor meets the
performance specifications. If the patient monitor or a module fails to perform as specified in any test, repairs or
replacement must be done to correct the problem. If the problem persists, contact Mindray Technical Support
Department.
CAUTION
All tests should be performed by qualified service personnel only.
Care should be taken when changing the settings in [User Maintenance>>] and [Factory
Maintenance>>] menus to avoid loss of data.
Service personnel should possess a working knowledge of the test equipment and make sure that test
tools and cables are applicable.
4.2 Preventative Maintenance
Preventative maintenance refers specifically to actions taken to prevent inaccurate results in the equipment. The
following sections provide a list of recommended preventative maintenance procedures and their recommended
frequencies.
4.2.1 Preventative Maintenance Frequency
Check/Maintenance Item
NIBP test
Pressure check
Leak test
Sidestream and
Leak test
Microstream CO2 tests
Performance test
and calibration
Calibration
Performance test
AG tests
Frequency
1. If the user suspects that the measurement is incorrect.
2. Following any repairs or replacement of relevant module.
3. Once a year.
4. AG leak test should be performed before AG measurement.
Calibration
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4.2.2 CO2 Tests
4.2.2.1 CO2 Leak test
Follow this procedure to perform the test:
1.
Plug the module into the module rack.
2.
Wait until CO2 warmup is finished and then completely block the gas inlet of the module or watertrap (you may
use a pneumatic plug or your finger to manually occlude the port). The sidestream and microstream CO2
modules will behave as follows:
Sidestream: The alarm message [CO2 FilterLine Err] is displayed on the screen after 3 seconds. Block the gas
inlet for another 60 s. Select [Main Menu] → [Maintenance >>] →[User Maintenance >>] → enter the
required password → [Maintain CO2 >>] → [Calibrate CO2 >>], and verify the flow rate is less than.
10ml/min. The module does not leak if current flow rate is less than 10ml/min and the alarm message does
not disappear.
Microstream: The alarm message [CO2 Purging] is displayed on the screen after a short time. Block the gas
inlet for another 30s. If alarm message [CO2 FilterLine Err] is shown, it indicates that the module does not
leak.
4.2.2.2 CO2 Accuracy Test
Tools required:
A gas cylinder with 5±0.03% CO2, 21.0% O2 and balance gas N2 (P/N 0075-00-0033-01), or a steel gas cylinder
with:
CO2 concentration 3% - 7%
a/c ≤ 0.01 (where a = absolute gas concentration accuracy, c = gas concentration)
balance gas N2
T-shape connector
Tubing
Follow this procedure to perform the test:
1.
Connect the CO2 module.
2.
Wait until the CO2 module warmup is finished. Check the airway for leak.
3.
Select [Main Menu] → [Maintenance >>] → [User Maintenance>>] → enter the required password→
[Module Maintenance>>] → [Maintain CO2 >>] → [Calibrate CO2 >>].
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Passport 12m Service Manual
4.
Connect the test system as follows:
Open to the air
Tubing
Valve
T-shape connector
Monitor
Gas cylinder
5.
Open the valve to flow CO2 and make sure that there is flow sufficient to vent to atmosphere.
6.
Verify the realtime CO2 value is within 5.0±0.3% in the [Calibrate CO2] menu.
4.2.2.3 CO2 Calibration
Tools required:
A gas cylinder with 5±0.03% CO2, 21.0% O2 and balance gas N2 (P/N 0075-00-0033-01), or a gas cylinder with:
CO2 concentration 3% - 7%
a/c ≤ 0.01 (where a = absolute gas concentration accuracy, c = gas concentration)
balance gas N2
T-shape connector
Tubing
Follow this procedure to perform a calibration:
1.
Make sure that the sidestream or microstream CO2 module has been warmed up.
2.
Check the airway for leaks.
3.
Select [Main Menu] → [Maintenance >>] → [User Maintenance >>] → enter the required password→
[Module Maintenance>>] → [Maintain CO2 >>] → [Calibrate CO2 >>].
4.
In the [Calibrate CO2] menu, select [Zero].
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5.
After the zero calibration is finished successfully, connect the equipment as follows:
Open to the air
Tubing
Valve
T-shape connector
Monitor
Gas cylinder
6.
Open the valve to flow CO2 and make sure that there is flow sufficient to vent to atmosphere.
7.
In the [Calibrate CO2] menu, enter the CO2 concentration in the [CO2] field.
8.
In the [Calibrate CO2] menu, the measured CO2 concentration is displayed. After the measured CO2
concentration becomes stable, select [Calibrate CO2] to calibrate the CO2 module.
If the calibration is completed successfully, the message [Calibration Completed!] is displayed in the [Calibrate CO2]
menu. If the calibration failed, the message “Calibration Failed!” is displayed. If the initial calibration fails, perform a
second calibration. If that attempt fails, contact Mindray Technical Support for assistance.
4.2.3 AG Tests
4.2.3.1 Leak Test
Follow this procedure to perform the test:
1.
Plug the AG module into the module rack.
2.
Wait until the AG module warmup is finished and then completely block the gas inlet of the AG module (you may
use a pneumatic plug or your finger to manually occlude the port). An alarm message [AG Airway Occluded] will
appear on the screen.
3.
Block the gas inlet for another 30 s. Select [Main menu] → [Maintenance >>] → [User Maintenance >>] →
enter the required password → [Calibrate AG >>], and verify the current flow rate is less than 10 ml/min.
If the alarm message does not disappear, it indicates that the module does not leak.
If the flow rate is less than 10ml/min and the alarm message [AG Airway Occluded] does not disappear, it indicates
that the module does not leak. If the alarm message disappears, or the flow rate is greater than or equal to 10ml/min,
it indicates that the module leaks. If the problem remains, contact your service personnel for assistance.
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Passport 12m Service Manual
4.2.3.2 Accuracy Test
Tools required:
A supply of medical grade 100% O2 and an anesthetic calibration gas (4% Desflurane, 6% CO2, 45% N2O, Bal O2,
P/N: 0075-00-0048-01 and flow regulator P/N: 0119-00-0235). Gas concentration should meet the following
requirements:
AA≥1.5%, CO2≥1.5%, N2O≥40%, O2≥40%, of which AA represents an anesthetic agent. a/c≤0.01 (a is the gas
absolute concentration accuracy; c is the gas concentration)
T-shape connector
Tubing
Follow this procedure to perform the test:
1.
Plug the AG module into the module rack.
2.
Wait at least 10 min and then perform a leak test to make sure the airway has no leak.
3.
Check if the fan inside the AG module works properly.
4.
Connect the test system as follows:
Open to the air
Tubing
Relief valve
Monitor
Gas cylinder
5.
Open the relief valve and vent a standard gas and make sure that there is an excess gas flow through the T-shape
connector to air.
6.
Verify the concentration of each composition meets the specification stated in the Operator's Manual.
WARNING
When performing AG accuracy test and AG calibration, be sure to dispose of exhaust gas properly.
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4.2.3.3 Calibration
Tools required:
Gas cylinder, Mindray P/N 0075-00-0048-01 and flow regulator P/N0119-00-0235 with an anesthetic calibration
gas (4% Desflurane, 6% CO2, 45% N2O, Bal O2, P/N: 0075-00-0048-01 and flow regulator P/N: 0119-00-0235). Gas
concentration should meet the following requirements: AA≥1.5%, CO2≥1.5%, N2O≥40%, O2≥40%, of which AA
represents an anesthetic agent. a/c≤0.01 (a is the gas absolute concentration accuracy; c is the gas
concentration).For 100% O2 calibration, a gas cylinder with 100% O2 is used and the O2 concentration is not less
than 99%.
T-shape connector
Tubing
Follow this procedure to perform a calibration:
1.
Select [Main Menu] → [Maintenance >>] → [User Maintenance >>] → enter the required password →
[Calibrate AG >>].
2.
Check the airway and make sure that there are no occlusions or leaks.
Vent the sampling tubing to the air and check if the [Current FlowRate] and [Set FlowRate] are
approximately the same. If the deviation is great, it indicates that there is an occlusion in the tubing. Check
the tubing for an occlusion.
3.
Perform a leak test to make sure that the airway has no leak.
Connect the test system as follows:
Open to the air
Tubing
Relief valve
Monitor
Gas cylinder
4.
Open the relief valve and vent an anesthetic calibration gas or gas mixture and make sure that there is an excess
gas flow through the T-shape connector to air.
5.
In the [Calibrate AG] menu, the concentration and flowrate of each measured gas are displayed.
If the difference between the measured gas concentration and the actual one is within tolerance, a
calibration is not needed.
If the difference is not within tolerance, a calibration should be performed. Select [Calibrate >>] to enter the
calibrate menu.
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Passport 12m Service Manual
6.
Enter the vented gas concentration. If you use only one gas for calibration, set other gases’ concentration to 0.
7.
Select [Start] to start a calibration.
8.
If the calibration is finished successfully, the message [Calibration Completed!] is displayed. If the calibration
failed, the message [Calibration Failed!] is displayed. Perform another calibration.
CAUTION
Calibrate the O2 module, if it has been transported for long distance or if you suspect it does not work
properly.
4.3 Performance Tests
Performance test are designed to ensure that measurement results are accurate. The following sections provide a list
of performance and accuracy tests and their recommended frequencies.
4.3.1 Performance Test Frequencies
Check/Maintenance Item
Frequency
Visual inspection
1. When first installed or reinstalled.
Performance test
1. If the user suspects that the measurement is incorrect.
2. Following any repairs or replacement of relevant module.
ECG test
Verification
3. At least once every two years. At least once a year is
recommended for NIBP, CO2 and AG.
Resp performance test
4. AG leak test should be performed before AG measurement.
SpO2 test
Pressure check
NIBP test
Leak test
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Temp test
Performance test
IBP test
Pressure calibration
C.O. test
Leak test
CO2 tests and
calibration
Performance test
Calibration
Leak test
AG tests
Performance test
Calibration
BIS test
RM test
CCO/SvO2 test
Interconnecting function
Output calibration
ScvO2 test
Nurse call relay performance test
If the user suspects that the nurse call or analog output does
Analog output performance test
not work correctly.
Device integration check
1. When first installed.
2. Following any repair or replacement of the external device.
4.3.2 Visual Inspection
Inspect the equipment for obvious signs of damage. Follow these guidelines when inspecting the equipment:
Carefully inspect the case, display screen, buttons and knob for obvious signs of damage.
Inspect the SMR and parameter modules for obvious signs of damage.
Inspect the power cord, wall-mount bracket and module accessories for obvious signs of damage.
Inspect all external connections for loose connectors, bent pins or frayed cables.
Inspect all connectors on the equipment for loose connectors or bent pins.
Make sure that safety labels and data plates on the equipment are clearly legible.
After visual inspection, replace any damaged equipment parts or accessories.
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Passport 12m Service Manual
4.3.3 ECG Tests
4.3.3.1 ECG Performance Test
Tool required:
Fluke Medsim 300B patient simulator or equivalent equipment
Follow this procedure to perform the test:
1.
Connect the patient simulator with the ECG module using an ECG cable.
2.
Set the patient simulator as follows: ECG sinus rhythm, HR=80 bpm with the amplitude as 1mV.
3.
Check the ECG waves are displayed correctly without noise and the displayed HR value is within 80 ± 1 bpm. If
the value is not within 80 +/-1 then contact Mindray Technical Support
4.
Disconnect each of the leads in turn and observe the corresponding lead off message displayed on the screen.
5.
Set the output of the simulator to deliver a paced signal and set [Paced] to [Yes] on the monitor. Check the pace
pulse marks on the monitor screen.
4.3.3.2 ECG Verification
Tool required:
Vernier caliper
Follow this procedure to perform verification:
1.
Select the ECG parameter window or waveform area → [Filter] → [Diagnostic].
2.
Select [Main Menu] → [Maintenance >>] → [User Maintenance >>] → enter the required password→
[Module Maintenance>>].
3.
Select [Calibrate ECG]. A square wave appears on the screen and the message [ECG Calibrating] is displayed.
4.
Compare the amplitude of the square wave with the wave scale. The difference should be within 5%. If the
difference is not within 5% contact Mindray Technical Support.
5.
After completing the verification, select [Stop Calibrating ECG].
4.3.4 Resp Performance Test
Tool required:
Fluke Medsim 300B patient simulator or equivalent equipment
Follow this procedure to perform the test:
1.
Connect the patient simulator to the module using a non ESU-proof cable and set lead II as the respiration lead.
2.
Configure the simulator as follows: lead II as the respiration lead, base impedance line as 1500 Ω; delta
impedance as 0.5 Ω, respiration rate as 40 rpm.
3.
Verify the Resp wave is displayed without any distortion and the displayed Resp value is within 40 ± 2 rpm.
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4.3.5 SpO2 Test
Tool Required:
None.
Follow this procedure to perform the test:
1.
Connect SpO2 sensor to the SpO2 connector of the monitor. Set [Patient Cat.] to [Adu] and [PR Source] to SpO2
on the monitor.
2.
Apply the SpO2 sensor to the ring finger of a healthy person.
3.
Check the Pleth wave and PR reading on the screen and make sure that the displayed SpO2 is within 95% and
100%. If you are unable to get the SPO2 between 95% and 100%, contact Mindray Technical Support.
4.
Remove the SpO2 sensor from the finger and make sure that an alarm of SpO2 Sensor Off is triggered.
NOTE
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor. However, it can
be used to demonstrate that a particular pulse oximeter monitor reproduces a calibration curve that
has been independently demonstrated to fulfill a particular accuracy specification.
4.3.6 NIBP Tests
4.3.6.1 NIBP Accuracy Test
Tools required:
T-shape connector
Appropriate tubing
Squeeze bulb
Rigid Vessel with volume 500 ± 25 ml
Reference manometer (calibrated with accuracy equal to or better than 0.75 mmHg)
Follow this procedure to perform the test:
1.
Connect the equipment as shown below.
Monitor
Manometer
Connector for NIBP cuff
Squeeze bulb
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Tubing
Rigid vessel
Passport 12m Service Manual
2.
Before inflation, the reading on the manometer should be zero. If not, disconnect the squeeze bulb to release any
pressure. Reconnect the squeeze bulb and verify that the pressure reading is zero.
3.
Select [Main Menu] → [Maintenance >>] → [User Maintenance >>]→ enter the required password→
[Module Maintenance>>] →[NIBP Accuracy Test].
4.
Check the manometer values and the monitor values. Both should be 0 mmHg.
5.
Raise the pressure in the rigid vessel to 50 mmHg with the squeeze bulb. Then, wait for 10 seconds until the
measured values become stable.
6.
Compare the manometer values with the monitor values. The difference should be within ±3 mmHg.
7.
Raise the pressure in the rigid vessel to 200 mmHg with the squeeze bulb. Then, wait for 10 seconds until the
measured values become stable and repeat step 6.
NOTE
You can use an NIBP simulator to replace the squeeze bulb and the reference manometer to perform
the test.
You can use an appropriate cylinder and a cuff instead of the rigid vessel.
4.3.6.2 NIBP Leakage Test
NOTE
You should perform the NIBP leakage test before any other NIBP test.
Tools required:
NIBP cuff for adult patient
Appropriate tubing
Rigid cylinder
Follow this procedure to perform the test:
1.
Set [Patient Cat.] to [Adu].
2.
Connect the NIBP cuff to the NIBP connector on the monitor.
3.
Wrap the cuff around the cylinder as shown below.
Monitor
Connector for NIBP cuff
4.
Rigid cylinder
NIBP hose
Cuff
Select [Main Menu] → [Maintenance >>] → [User Maintenance >>] → enter the required password→
[Module Maintenance>>] → [NIBP Leakage Test]. The message [Leakage Testing…] is displayed in the NIBP
parameter area.
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5.
The cuff automatically deflates after 20s, which means NIBP leakage test is completed.
If no message is displayed in the NIBP parameter area, it indicates that the system does not leak. If the message
[NIBP Pneumatic Leak] is displayed, it indicates that the system may have a leak. In this case, check to make sure
the NIBP cuff, hose and connectors are not leaking and perform the test again.
You can also perform a manual leak test:
1.
Perform procedures steps 1 to 4 in the NIBP Accuracy Test.
2.
Raise the pressure in the rigid vessel to 250 mmHg with the squeeze bulb. Then, wait for 5 seconds to let the
measured values becoming stable.
3.
Record the current pressure value, and then, record the pressure value after 60s.
4.
Compare the two pressure values and make sure the difference is not greater than 6 mmHg.
4.3.7 Temp Test
Tool required:
Resistance box (with accuracy above 0.1Ω) or equivalent in Patient Simulator
Follow this procedure to perform the test:
1.
Connect the two pins of any Temp connector of a module to the two ends of the resistance box using 2 wires.
2.
Set the resistance box to 1354.9Ω (corresponding temperature is 37ºC).
3.
Verify that the displayed value is within 37 ± 0.1ºC. If the temperature is not within 37 ± 0.1ºC, contact Mindray
Technical Support.
4.
Repeat steps 1 to 3 and verify another temperature channel.
4.3.8 IBP Tests
4.3.8.1 IBP Performance Test
Tools required:
Medsim300B patient simulator, or MPS450, or equivalent equipment
IBP adapter cable for test (P/N 009-002199-00 for Medsim 300B, P/N 009-002198-00, for MPS450)
Follow this procedure to perform the test:
1.
Connect the patient simulator to the monitor’s IBP connector.
2.
Verify the patient simulator output to the IBP channel is zero.
3.
Select IBP Zero in the IBP setup menu to make a zero calibration.
4.
Configure the patient simulator as P (static) = 200 mmHg.
5.
The displayed value should be within 200 ± 4 mmHg. If the error is beyond ±4 mmHg, return the IBP module to
the factory for repair.
6.
Set the patient simulator output to 120/80 mmHg ART signal and 120/0 mmHg LV signal to the IBP channel and
check that the IBP wave is displayed correctly.
7.
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Repeat the steps above for all the IBP channels.
Passport 12m Service Manual
4.3.8.2 IBP Pressure Calibration
Method 1:
Tools required:
Medsim300B Patient simulator, MPS450, or other equivalent device
Dedicated IBP adapter cable (300B, P/N 00-002199-00) (use P/N 00-002198-00, if the simulator is MPS450)
Follow this procedure to perform the test:
1.
Connect the patient simulator to the pressure connector on the module.
2.
Set the patient simulator to 0 pressure for the desired IBP channel.
3.
Press the Zero Key on the module to perform a zero calibration.
4.
Configure the patient simulator as P (static) = 200 mmHg.
5.
Select [Main Menu] → [Maintenance >>] → [User Maintenance >>] → [Cal. IBP Press. >>]. In the [Cal. IBP
Press.] menu, set the calibration value to 200 mmHg.
6.
Select the [Calibrate] button next to the desired IBP channel to start a calibration.
7.
If the calibration is completed successfully, the message [Calibration Completed!] will be displayed. Otherwise,
a corresponding message will be displayed.
Method 2:
Tools required:
Standard sphygmomanometer
Squeeze bulb
Tubing
T-shape connector
To perform a calibration:
1.
Connect the 3-way stopcock, the sphygmomanometer and the squeeze bulb 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 equipment’s front panel. Select [Maintenance>>] → [User Maintenance >>]
→ enter the required password → [Cal. IBP Press. >>]. Then configure IBP calibration value.
4.
Inflate using the squeeze bulb until the reading of sphygmomanometer approximates the preset calibration
value.
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Pressure transducer
3-way stopcock
T-shape connector
Pressure adapter cable
IBP Module
Sphygmomanometer
5.
Adjust the calibration value in the [Cal. IBP Press.] menu until it is equal to the reading on the
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.
4.3.9 C.O. Test
Tools required:
Medsim300B Patient simulator
C.O. adapter box
Follow this procedure to perform the test:
1.
Connect the patient simulator to the C.O. module using a C.O. main cable.
2.
Set the blood temperature (BT) to 37ºC on the patient simulator and check the temperature value is 37 ± 0.1ºC.
3.
Set [Auto IT] to [Off] and adjust [IT] to 24ºC. Select [C.O. Measure] to enter the C.O. measurement window and
set [Comp. Const.] to 0.595.
4.
Set the injectate temperature to 24ºC and the C.O. to 5L/min on the C.O. simulator. Select [Start] in the C.O.
measurement window to start C.O. measurements and after 3-10 seconds press the run key on the simulator.
5.
Check the C.O. value is 5±0.25L/min.
4.3.10 CO2 Tests
See section 4.2.2 CO2 Tests.
4.3.11 AG Tests
See section 4.2.3AG Tests.
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Passport 12m Service Manual
4.3.12 BIS Test
Tools required:
None.
1.
Connect the BIS sensor to a healthy, wide-awake adult as directed in the Operator’s Manual.
2.
Check the EEG wave and BIS numerics displayed on the screen and make sure the BIS value is within 80-100.
4.3.13 RM Test
Tool required:
Gas source
Ventilator (calibrated)
Artificial lung
Pediatric/neonate flow sensor
Monitor
Artificial lung
Ventilator
Flow sensor
Follow this procedure to perform the test:
1.
Connect the equipment as shown above. Make sure that the blue sensing tube on the flow sensor is connected
with the artificial lung.
2.
Set [Patient Cat.] to [Adu]. In the [RM Setup] menu, select [Sensor Type] according to the used sensor and set
[Ventilation Mode] to [Mechanical].
3.
Enter the [RM Setup] menu and select [Calibrate >>]. Input the constant marked on the sensor and calibrate the
flow sensor.
4.
Configure the ventilator as follows: Vt=500 ml, RR =20 rpm, I:E=1:2.
5.
Select [Respiratory Loop] in the [RM Setup] menu. Verify that the displayed TV is within 500±50ml and RR is
within 20±1rpm.
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4.3.14 CCO/SvO2 Tests
4.3.14.1 Interconnecting Function
Tools required:
None.
1.
Connect and set the patient monitor and Vigilance monitor per the procedures in the Operator’s Manual.
2.
Set the Vigilance monitor to Demo mode.
3.
Verify the CCO/SvO2 numerics displayed on the patient monitor and Vigilance monitor are consistent.
4.3.14.2 Output Performance
Tools required:
Oscilloscope
1.
Connect the signal output end of the connecting cables of the CCO/SvO2 module to the oscilloscope.
2.
Perform an ECG calibration on the monitor. Verify the ECG waves displayed on the oscilloscope are consistent
with the ECG calibration waves displayed on the monitor screen.
3.
Select [CCO Setup] → [Signal Output Setup >>] and then select [Simulated High Value] from the pop-up
menu. Verify the amplitude of the electrical level at the signal output port of MAP, CVP and SpO2 are 5±0.25V,
5±0.25V and 10±0.5V respectively.
4.3.15 ScvO2 Tests
Tools required:
None.
1.
Connect the ScvO2 sensor to the patient monitor. Verify the front end of the ScvO2 sensor illuminates normally.
2.
Pinch the front end of the ScvO2 sensor with two fingers.
3.
Verify the patient monitor displays the ScvO2 measurement normally.
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Passport 12m Service Manual
4.3.16 Nurse Call Relay Performance Test
Tools required:
Multimeter
1.
Connect the nurse call cable to the Nurse Call Connector of the patient monitor.
2.
Enter Demo mode. Then, select [Main Menu] → [Maintenance >>] → [User Maintenance >>] → enter the
required password → [Others >>] → [Auxiliary Output] → [Nurse Call].
3.
In the [Others >>] menu, select [Nurse Call Setup >>] and then select all options of [Alm Lev] and [Alarm Cat.]
and set [Contact Type] to [Normally Open]
4.
In [Nurse Call Setup >>] setup menu, set [Signal Type] to [Pulse]. Cause the monitor to generate an alarm and
verify the output are pulses of 1s width and the relay contacts are closed (can be measured with a multimeter)
when there is an alarm.
5.
In [Nurse Call Setup >>] setup menu, set [Signal Type] to [Continuous]. Cause the monitor to generate an
alarm and verify the output is continuous high level and the relay contacts are closed (can be measured with a
multimeter) when there is an alarm.
4.3.17 Analog Output Performance Test
Tools required:
Patient simulator
Oscilloscope
1.
Connect the patient simulator to the monitor using an ECG or IBP cable and connect the oscilloscope to the
Auxiliary Output Connector of the patient monitor.
2.
Select [Main Menu] → [Analog Output Setup]. Switch Analog Output [On].
3.
Verify that the waves displayed on the oscilloscope are identical with those displayed on the monitor.
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4.3.18 BeneLink Module Check
4.3.18.1 Device Connection and Setup
Tools required:
External device (anesthesia machine, ventilator)
ID adapter that maches the external device
RJ45 connecting cable
Serial port adapter cable that maches the external device
Please refer to the following procedure to connect an external device:
RJ45 Connecting
BeneLink Module
Cable
ID Adapter
Label
External Device
Serial Port Adapter
Cable (Optional)
1.
Insert the BeneLink module into the module slot on the patient monitor.
2.
Connect the ID adapter that matches the external device to the BeneLink module with a RJ45 connecting cable.
3.
Plug the ID adapter into the RS232 port on the external device. Some external devices may have ports
incompatible with the ID adapter. In this case, a serial port adapter cable is required. Please be sure that you have
selected the proper cable before connection. For the detailed information of the serial port adapter cable, see
below table of this section.
4.
Attach a label indicating device name to the RJ45 connecting cable at the end closer to the BeneLink module.
When the BeneLink module is connected to several external devices, you can tell the devices apart easily with
these labels.
5.
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Switch the external device on.
Passport 12m Service Manual
NOTE
Devices in the same category can not be connected to the BeneLink module simultaneously.
Use the serial port adapter cable only with its matching extermal device. Please see the following table
to select the correct adapter cable.
Use the ID adapter only with the matching external device. Please see the following table for correct ID
setup in [Factory Maintenance] menu.
External Device
ID for ID adapter
Type of Serial Port Adapter Cable
No need to use the adapter cable: the ID
Mindray A3/A5
4D52B2AE
adapter can be plugged into the serial port of
the external device directly.
Newport E360
4E50B1B0
Type B
SNDF:5042AFBE(recommended) No need to use the adapter cable: the ID
Puritan Bennett 840
SNDA:5031AFCF(supports fewer
adapter can be plugged into the serial port of
parameters than protocol SNDF)
the external device directly.
Maquet Flow-i
4D46B2BA
Type B
Maquet Servo-i/Servo-s
4D53B2AD
Type B
4434BBCC
Type B
Hamilton G5 (protocol Polling)
3550CAB0
Type B
Hamilton C2 (protocol Polling)
3270CD90
Type B
4750B8B0
Type B
Hamilton G5 (protocol Block)
3542CABE
Type B
Ohmeda Avance/Aisys
4F41B0BF
Type D
Ohmeda Aestiva 7100/7900
4F37B0C9
Type D
Draeger Evita 2/Evita 2 dura/Evita
4/Evita XL
Hamilton Galileo (protocol
Polling)
GS: no need to use the adapter cable: the ID
adapter can be plugged into the serial port of
Drager Fabius GS/Plus/Trio
4446BBBA
the external device directly.
Plus: type C
Trio: type C
Drager Primus
4450BBB0
Type C
TCM CombiM/TCM TOSCA
5443ABBD
Type C
TOF-Watch SX
5457ABA9
Type C
Expand Model
/
Type A
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Serial port adapting cable
PN
Remark
Type A
009-001767-00
Male to female
Type B
009-001768-00
Male to male
Type C
009-001769-00
Male to male
Type D
009-002943-00
9-pin to 15-pin
4.3.18.2 Device Integration Function Test
Preparation
Prepare the tools and/or equipment necessary for function testing according to the type of external device you install.
Please see the Instructions for Use of the corresponding external device for guidance. For the function testing of
ventilator and anesthesia machine, the following tools are required:
Passport 12M patient monitor with BeneLink module properly installed
External device under test (anesthesia machine or ventilator) under test
Gas source(tube or gas cylinder), including medical air or oxygen . Other anethetic gases such as N2O are
optional.
Test lung and a matching Y-tubing, or other accessories
Procedure and Items to Be Checked
Follow the steps below:
1.
Connect the BeneLink module to the ventilatior or the anesthesia machine. See Device Connection and Setup for
more details.
2.
Connect the gas supply and test lungs to the ventilator or anesthesia machine, turn on the device, and configure
as follows:
3.
Set up the serial port of the external device by refering to Serial Port Configuraion List.
Set up the pressure control mode and verify the ventilator or anesthesia machine works properly.
Make sure the ID adapter is properly configured and the green indicator of corresponding port on the BeneLink
module illuminates constantly.
4.
Access the [Devices Integrated] screen on the patient monitor. Verify the device type (ventilator or anesthesia
machine) and ventilation mode are properly displayed.
5.
Select parameters PEEP, Pmean, VTe, MV, I:E, and f (RR) and verify the parameter values displayed on the patient
monitor are consistent with those displayed on the ventilator or anesthesia machine.
6.
Re-configure the above parameters on the ventilatior or the anesthesia machine and verify the parameter values
displayed on the patient monitor change accordingly.
7.
Trigger alarms [MV Too Low], [Airway Pressure Too High], [PAW Too High], [Peak Too High], and [No Gas
Supply] (no Air or O2) on the ventilatior or the anesthesia machine. Verify these alarm messages are properly
recorded in the alarm list of the patient monitor.
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Passport 12m Service Manual
8.
Switch the ventilator or anesthesia machine to volume control ventilation mode. Verify the ventilation mode
displayed on the patient monitor changes accordingly, and that the parameter values for PEEP, Pmean, VTe, MV,
I:E, and f (RR) are displayed properly.
Serial Port Configuration List
External Device
Setup
Remark
If you need to view the parameters of CO2、AG、
BIS module in the anesthesia machine, select
Mindray Wato 20/30/55/65
Not required.
[Factory Mainenance>>] → [Function
Configuration>>] → [Select Module] in standby
mode and tick the corresponding module.
The following information is for further reference:
Maquet Servo-i
Maquet Servo-s
Baud Rate: 9600 bps
Not required.
Word Length: 8 bits
Parity: even
Stop Bits: 1
Channel A: Not required;
Channel B:
Draeger Evita 2
Protocol: Medibus
Baud rate: 19200
/
Parity: even
Stop Bits: 1
Protocol: Medibus
Draeger Evita 2 dura/ Evita 4/ Evita
XL
Baud Rate: 19200
Parity: even
/
Stop Bits: 1
Interval: ---( Evita 2 dura)
The following information is for further reference:
Baud Rate: 38400 bps
Newport E360
Protocol: Newport
Word Length: 8 bits
Parity: NONE
Stop Bits: 1
Baud Rate: 38400
Puritan Bennett 840
Word Length: 8 bits
/
Parity: NONE
The following information is for further reference:
Baud Rate: 9600 bps
Hamilton G5(protocol Polling)
Protocol: Polling.
Word Length: 7 bits
Parity: even
Stop Bits: 2
The following information is for further reference:
Baud Rate: 9600 bps
Hamilton C2(protocol Polling)
Protocol: Polling.
Word Length: 7 bits
Parity: even
Stop Bits: 2
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External Device
Setup
Remark
The following information is for further reference:
Baud Rate: 9600 bps
Hamilton Galileo(protocol Polling) Not required.
Word Length: 7 bits
Parity: even
Stop Bits: 2
The following information is for further reference:
Baud Rate: 38400 bps
Hamilton G5(protocol Block)
Protocol: Block.
Word Length: 8 bits
Parity: none
Stop Bits: 1
The following information is for further reference:
Baud Rate: 19200 bps
Ohmeda Avance/Aisys
Not required.
Word Length: 7 bits
Parity: odd
Stop Bits: 1
The following information is for further reference:
Baud Rate: 19200 bps
Ohmeda Aestiva 7100 /7900
Not required.
Word Length: 7 bits
Parity: odd
Stop Bits: 1
Protocol: Medibus
Baud Rate: 9600
Drager Fabius GS/Plus/Tiro
Word Length: 7 bits
/
Parity: even
Stop Bits: 1
Protocol: Medibus
Baud Rate::9600
Drager Primus
Word Length: 8 bits
/
Parity: even
Stop Bits: 1
The following information is for further reference:
Baud Rate: 9600 bps
TCM CombiM/TCM TOSCA
Protocol: Monlink.
Word Length: 8 bits
Parity: even
Stop Bits: 1
The following information is for further reference:
Baud Rate: 19200 bps
TOF-Watch SX
Not required.
Word Length: 8 bits
Parity: none
Stop Bits: 1
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Passport 12m Service Manual
4.4 Electrical Safety and Other Tests
4.4.1 Electrical Safety and Other Test Frequencies
Check/Maintenance Item
Frequency
Electrical safety tests
Refer to Appendix A Electrical Safety Inspection.
1. When first installed or reinstalled.
Power on test
2. Following any maintenance or the replacement of any main
unit parts.
1. When the touchscreen accuracy diminishes.
Touchscreen calibration
2. After the touchscreen is replaced.
Recorder check
Following any repair or replacement of the recorder.
1. When first installed.
Network print test
Battery check
2. Whenever the printer is serviced or replaced.
Function test
1. When first installed.
2. Whenever a battery is replaced.
Performance test
Once a year or if the battery run time is significantly reduced.
4.4.2 Electrical Safety Test
See Appendix A Electrical Safety Inspection for electrical safety tests.
4.4.3 Power On Test
This test is to verify that the patient monitor can power up correctly. The test is passed if the patient monitor starts up
by following this procedure:
1.
Insert two batteries in the battery chamber and connect the patient monitor to the AC mains, the AC mains LED
and battery LED light.
2.
Press the power on/off switch to switch on the patient monitor. The operating status LED lights up, and the
technical and physiological alarm lamps light blue and red respectively.
3.
After the start-up screens are displayed, the system sounds a beep indicating the self test on alarm sounds is
passed. At the same time, the alarm lamp turns from yellow to red, and then turns off together with the technical
alarm lamp. This indicates that the self test on alarm lamps is passed.
4.
The patient monitor enters the main screen and start-up is finished.
Passport 12m Service Manual
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4.4.4 Touchscreen Calibration
Tools required:
None.
1.
Select [Main Menu] → [Maintenance >>]→ [Cal. Touchscreen]. The
symbol will appear at different
positions on the screen.
2.
Touch, in turn, the central point of the
Calibration Completed!] is displayed.
3.
Select [Ok] to confirm.
symbol. After the calibration is completed, the message [Screen
4.4.5 Recorder Check
Tools required:
None.
1.
Print ECG waveforms. The recorder should print correctly and the printout should be clear.
2.
Remove the paper roll to generate an out of paper error. The patient monitor should display the proper message
for the condition created. After the problem is removed, the recorder should work properly.
3.
Switch on automatic alarm recording for each parameter and then set each parameter’s limit outside set alarm
limits. Corresponding alarm recordings should be triggered when parameter alarms occur.
4.4.6 Network Print Test
Note
Use the recommended printers specified in the operator’s manual (PN: 046-005013-00).
Tools required:
Hub and network cable
4.4.6.1 Equipment Connection and Setup
1.
Connect the patient monitor and network printer to a HUB using common network cables as follows:
Passport 12M
Network printer
monitor
Cable
Cable
HUB
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Passport 12m Service Manual
2
Set IP address as follows: Select [Main Menu] → [Maintenance >>] → [User Maintenance >>] → enter the
required password → [Network Setup >>] → [Monitor Network Setup >>], set the IP address of the patient
monitor in the same network segment with that of the network printer. (See the instructions for use
accompanying the printer)
3
Search for printer by selecting [Main Menu] → [Print Setup >>] → [Printer Setup >>] → [Search Printer]. After
a while, the printer’s model and IP address will appear in the box beside [Printer].
4.4.6.2 Print Function Test
1
Enter the Demo mode of the patient monitor.
2
Select [Main Menu] → [Print Setup >>] → [Realtime Reports >>] → [Normal Report] and then select [Print].
The network printer should print out the report correctly.
4.4.7 Battery Check
Tools required:
None.
4.4.7.1 Function Test
1.
Remove any batteries that are installed in the patient monitor.
2.
Verify that the patient monitor works properly when running on AC power.
3.
Insert two fully charged batteries per the procedures provided in the Operator’s Manual.
4.
Remove the AC power cord and verify that the patient monitor still works properly.
5.
Remove one battery and verify that the patient monitor continues to work correctly. Verify that the patient
monitor can also work independently from the other battery.
4.4.7.2 Performance Test
Perform the test procedure in the Battery chapter in the Operator’s Manual and verify the operating time of the
battery meets the product specification.
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4.5 Factory Maintenance
4.5.1 Accessing Factory Maintenance Menu
To access the factory maintenance menu, select [Main Menu] → [Maintenance >>] → [Factory Maintenance] and
then enter the required password.
The [Factory Maintenance] menu is shown below.
4.5.2 Drawing Waves
In the [Factory Maintenance>>] menu, select [Draw Wave] to define the method to draw waves. There are two
methods to draw waves:
Color: selecting Color will have smoother waveforms.
Mono: selecting Mono will have a wider viewing angle.
4.5.3 Enabling/Disabling the Recorder
To enable/disable the recorder, select [Recorder] and toggle between [On] and [Off].
CAUTION
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The recorder is disabled if [Recorder] is switched off in the [Factory Maintenance>>] menu.
Passport 12m Service Manual
4.5.4 Checking Software Version
In the [Factory Maintenance] menu, select [Software Version] to show software version information. The [Software
Version] menu is as follows:
4.5.5 Checking Monitor Information
In the [Factory Maintenance] menu, select [Monitor Information] to show the status of the patient monitor.
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FOR YOUR NOTES
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5 Troubleshooting
5.1 Introduction
In this chapter, patient monitor problems are listed along with possible causes and recommended corrective actions.
Refer to the tables to check the patient monitor, identify and eliminate these problems.
For more information on troubleshooting, contact our Mindray Technical Support Department.
5.2 Part Replacement
Printed circuit boards (PCBs), major parts and components in patient monitors are replaceable. Once you isolate a PCB
you suspect defective, follow the instructions in Repair and Disassembly to replace the PCB with a known good one.
Verify proper operation and that the patient monitor passes all performance tests.
To obtain information on replacement parts, refer to Parts.
5.3 Patient Monitor Status Check
Some troubleshooting tasks may require you to identify the hardware version and status of your patient monitor.
1.
To view the information on system start time, self check, etc., select [Main Menu] → [Maintenance >>] →
[Monitor Information >>].
2. You can also view the information on the monitor’s current status by selecting [Main Menu] →[Maintenance>>]
→ [Factory Maintenance>>] → enter the required password → [Monitor Information >>].
5.4 Software Version Check
Some troubleshooting tasks may require you to identify the configuration and software version of your patient
monitor.
1.
To view information on the system configuration and system software version, Select [Main Menu] →
[Maintenance>>] → [Software Version>>].
2.
You can also view the information on system software version and module software version by selecting [Main
Menu] → [Maintenance>>] → [Factory Maintenance>>] → enter the required password →[Software
Version>>].
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5-1
5.5 Technical Alarm Check
Before troubleshooting the patient monitor, check for technical alarm message. If an alarm message is presented,
eliminate the technical alarm first. For detailed information on technical alarm messages, possible causes and
corrective actions, refer to the 12M’s Operation Manual.
5.6 Troubleshooting Guide
5.6.1 Power On/Off Failures
Symptoms
Possible Cause
Corrective Action
The patient
AC mains not connected or
Verify the AC mains is properly connected or battery capacity is
monitor fails to
battery too low
sufficient.
start. AC LED or
Power supply protection
Refer to 5.6.9 Power Supply Failures .
Cables defective or poorly
1.
battery LED does
not light
connected
Verify the cables from power switch & LED board to button board,
button board to main board, and power module to main board
are correctly connected.
2.
Power switch & LED board
Verify the cables and connectors are not damaged.
Replace the power switch & LED board.
defective
Power module defective
Replace the power module.
Mother board Defective
Replace the mother board.
5.6.2 Display Failures
Symptoms
Possible Cause
Corrective Action
Integrated
Cables defective or poorly
1.
display is blank.
connected.
Verify the cable from the display to the mother board and the
cables from the backlight board respectively to the button board
and the display are correctly connected.
2.
Verify the cables and connectors are not damaged.
Backlight board defective
Replace the backlight board.
Power module defective
Replace the power module.
Display defective
Replace the display.
Secondary
Cables defective or poorly
1.
display does not
connected.
function.
monitor is correctly connected.
2.
DVI interface board
Verify the cable between the secondary display and the patient
Verify the cables and connectors are not damaged.
Replace the DVI interface board.
defective
Secondary
Cables defective or poorly
display shows
connected.
snows or flashing
5-2
1.
Verify the cable between the display and the patient monitor is
correctly connected.
2.
Verify the cables and connectors are not damaged.
Passport 12m Service Manual
specks
DVI interface board
Replace the DVI interface board.
defective
The mother board is
Replace the mother board.
defective.
Images
FPGA error.
Update or upgrade FPGA.
overlapped or
Cables defective or poorly
1.
distorted
connected.
connected.
2.
Touchscreen
Verify the cable between the display and mother board is correctly
Verify the cables and connectors are not damaged.
Touchscreen disabled
Check if there is a symbol
does not respond
shown above the [Main Menu]
QuickKey. If yes, press the [Main Menu] QuickKey for more than 3s to
enable the touchscreen.
Cables defective or poorly
1.
connected.
Verify the cables from the touchscreen to the touchscreen control
board, the touchscreen control board to the button board, and the
button board to the mother board are correctly connected.
2.
Touchscreen control board
Verify the cables and connectors are properly connected.
Replace the touchscreen control board.
defective
Button board defective.
Replace the button board.
Touchscreen defective.
Replace the touchscreen.
Mother board defective
Replace the mother board.
Touchscreen
Touchscreen needs to be
Calibrate the touchscreen.
accuracy is off
calibrated
5.6.3 Module Rack Failures
Symptoms
Possible Cause
Corrective Action
SMR cannot
Extension Cable defective or
1.
identify parameter
improperly connected
SMR
modules
Defective parameter module
Verify the powered USB cable between SMR and main unit is
connected to the SMR connector on the monitor.
2.
Verify the connecting cables and connectors are not damaged.
3.
Check that contact screws on SMR are tight.
Replace the malfunctioning parameter module with a known good
module. If the patient monitor identifies the replacement module,
the original module is faulty.
Wrong communication board
Upgrade the module and/or the SMR software to a compatible
software revision
level.
Module is not recognized in
Replace the Nios II module.
all slots, only certain slots.
Replace the 8-slot module rack communication board.
Passport 12m Service Manual
5-3
Power supply failure
1.
Verify there is 12VDC potential as measured across two contact
points for a module slot. If yes and the parameter module
functions properly then the PCB assembly in SRM might be
faulty.
2.
If there is no 12 VDC power sent to the SMR, check whether the
power voltage output to the USB_Hub board by the power
module reaches 12VDC. If yes, the fuse of the USB interface
board might be open. Replace the USB_Hub board.
Cable defective or improperly
1.
connected
Verify the cable between the SMR interface board and the
communication board is properly connected.
2.
Verify the connecting cables and connectors are not damaged.
Nios II module loose or not
1.
Verify the Nios II module is correctly connected.
working
2.
If the symptom persists, replace the Nios II module.
SMR interface board failure
Replace the SMR interface board.
SMR communication board
Replace the SMR communication board.
failure
USB_Hub board failure
Replace the USB_Hub board.
Mother board failure
Replace the mother board.
Integral module rack
Integral module
Module failure
rack cannot
Replace parameter module. If a new module is identified, the
original one is defective.
identify parameter
Cable defective or improperly
modules
connected
1.
Verify the cables from the 3-slot module rack communication
board to the MPM module rack communication board, and the
module rack to the mother board are properly connected.
2.
Verify the connecting cables and connectors are not damaged.
Wrong communication board
Upgrade the module or the integral module rack software to a
software revision
compatible version.
Module is not recognized in
Replace the corresponding module rack communication board.
all slots, only certain slots.
Power supply to integral
1.
module rack is not correct
Verify there is 12VDC potential as measured across two contact
points for a module slot. If yes and the parameter module
functions, PCB assembly in the SMR might be faulty.
2.
If there is no 12VDC sent to the integrated module rack, verify
the power module output voltage to the mother board
reaches 12VDC. If yes, the mother board might be faulty.
3-slot or MPM module rack
Replace the 3-slot or MPM module rack communication board.
communication board failure
5-4
Nios II module failure
Replace the Nios II module.
Mother board failure
Replace the mother board.
Passport 12m Service Manual
5.6.4 Alarm Problems
Symptoms
Possible Cause
Corrective Action
No visual alarm
Cable defective or improperly
1.
indicator when
connected
and button board to the mother board are properly
the audible
connected.
alarm is
sounding.
Verify the cables from the alarm LED board to the button board
2.
Verify the connecting cables and connectors are not damaged.
Alarm LED board failure
Replace the alarm LED board.
Button board failure
Replace the button board.
Mother board failure
Replace the mother board.
No audible
Select [Main Menu] → [Maintenance >>] → [User
alarm sounds
Maintenance >>] → enter the required password → [Alarm
emitted when
visual alarm is
Audible alarm is disabled
activated.
Setup >>], and then in the popup menu, set [Minimum Alarm
VolumeAlm Sound] to appropriate setting [On]. In the [Others]
window of the [Alarm Setup] menu, set [Alm Volume] to
appropriate setting.
Cable defective or poorly
connected
1.
Verify the cable between speaker and mother board is properly
connected.
2.
Verify the connecting cables and connectors are not damaged.
FPGA audio logic error
Upgrade the audio logic part of the FPGA program.
Speaker failure
Replace the speaker.
Mother board failure
Replace the mother board.
5.6.5 Button and Knob Failures
Symptoms
Possible Cause
Corrective Action
Buttons do not work
Cable defective or poorly
1.
Verify the cable between the button board and mother board
2.
Verify the connecting cables and connectors are not damaged.
connected
is properly connected.
Button board failure
Replace the button board.
Rotary encoder does
Cable defective or
1.
not work
improperly connected
Verify the cables from the knob to the button board, and the
button board to the mother board are properly connected
2.
Verify the connecting cables and connectors are undamaged.
Encoder failure
Replace the encoder.
Button board failure
Replace the button board.
Passport 12m Service Manual
5-5
5.6.6 Recorder Failures
Symptoms
Possible Cause
Corrective Action
No printout
Recorder module
1.
Verify the recorder status LED is lit.
disabled
2.
If yes, enable the module in the [Factory Maintenance] menu. If it is
not lit, check for other possible causes.
Paper is installed
Remove and reinstall the paper roll properly.
upside down
Cable defective or
1.
improperly connected
properly connected.
2.
Recorder power supply
Verify the cable between the recorder and the mother board is
Check that the connecting cables and connectors are not damaged.
Verify the power module’s 5 VDC and 12VDC outputs are present.
failure
Recorder failure
Replace the recorder.
Poor print quality
Paper roll not properly
Stop the recorder and re-install the paper roll.
or paper not
installed
feeding properly
Print head dirty
1.
Verify the thermal print head and the paper roller for foreign matter.
2.
Clean the thermal print head with an appropriate cleaning solution.
Print head failure
Replace the recorder.
Recorder failure
Replace the recorder.
5.6.7 Output Interface Failures
Symptoms
Possible Cause
Corrective Action
No analog signals or nurse
Respective output disabled
1.
call signals are generated
Select [Main Menu] → [Analog Output Setup] → set
[Analog Output] to [On].
USB_Hub board cable is
1.
loose
Verify the cable between the USB_Hub board and the
mother board is properly connected.
2.
Verify the connecting cables and connectors are not
damaged.
USB_Hub board failure
Replace the USB_Hub board.
Mother board failure
Replace the mother board.
Connected USB devices
Cable defective or not
1.
not working. (It is assumed
connected properly
these devices are working
elsewhere).
5-6
mother board is properly connected.
2.
properly when connected
Verify the cable between the USB_Hub board and
Verify the connecting cables and connectors are not
damaged.
USB_Hub board failure
Replace the USB_Hub board.
Mother board failure
Replace the mother board.
Passport 12m Service Manual
5.6.8 CF Card Problems
Symptoms
Possible Cause
Corrective Action
CF card malfunctions
Wrong CF card or insufficient
Use only SanDisk-manufactured CF storage cards. Those
storage capacity size
with 1GB memory space are recommended.
CF card full; data error; CF card
Format CF card on PC.
error
CF card failure
Replace the CF card.
Cable defective or poorly
1.
connected
Verify the cable between the CF card board and the
mother board is correctly connected.
2.
Check that the connecting cables and connectors not
damaged.
CF card pcb failure
Replace the CF card pcb.
Mother board failure
Replace the mother board.
5.6.9 Power Supply Failures
Symptoms
Possible Cause
Corrective Action
Battery voltage is too
Battery failure
Replace battery.
low
Cable defective or improperly
1.
Verify the cable is properly connected.
connected
2.
Verify the connecting cables and connectors are not
damaged.
Battery cannot be
Power board failure
Replace the power board.
Battery failure
Replace the battery and charge fully. If this is successful, the
recharged
original battery is faulty.
Cable defective or improperly
1.
connected
and power module is correctly connected.
2.
No +3.3 VDC output
Verify the cable between the battery interface board
Verify the cables and connectors are not damaged.
Power board failure
Replace power board
1.
Power supply protected
1.
Turn off the patient monitor then restart it.
2.
Power board failure
2.
If the problem remains, disconnect the AC mains for 5 s
and reconnect it, then restart the patient monitor.
No +5.0 VDC output
3.
If the problem still remains, replace the power board.
No +12 VDC output
Passport 12m Service Manual
5-7
NOTE
When the power module fails, it may cause damage to other components, e.g. the monitor suddenly
fails during start-up, due to supply protection. In this case, troubleshoot the power module per the
procedure described in the table above.
Components of the main unit, SMR and parameter modules are powered by the power module. In the
event that a component malfunctions, verify the operating voltage is correct. Refer to 2 Theory of
Operation for the operating voltage and measurement points for each component.
5.6.10 Wi-Fi Related Problems
Symptoms
Possible Cause
Corrective Action
The monitor is frequently off
The Wi-Fi signal is unstable in
1. Check if the Mindray recommended wireless AP is used.
line or disconnects from the
the operating area.
If not, verify the AP effective transmission rate meets the
Wi-Fi network. The
throughput requirements of the connected devices.
transmission delay is too
2. Verify the AP channel bandwidth is 20 MHz.
long.
3. Verify where the monitor is located, the wireless AP
signal strength is no less than -65 dBm.
4. Verify where the monitor is located, the signal strength
of other Wi-Fi devices at the same channel is no greater
than -85 dBm.
5. Verify where the monitor is located, the signal strength
of other Wi-Fi devices of adjacent channels is no greater
than -50 dBm.
6. Verify that the recommended distance between the
monitor and other non-Wi-Fi wireless devices, including
wireless devices at the frequency of 2.4GHz, cellular
mobile communication networks, microwave ovens,
intercoms, cordless phones and electro-surgical units, is
no less than 20 cm.
7. Verify that no unauthorized devices are connected to
the wireless AP.
The monitor's Wi-Fi antenna is
Disassemble the monitor and properly attach the Wi-Fi
detached from or not properly
antenna.
connected with the Wi-Fi
module.
5-8
Wi-Fi antenna defective
Replace the Wi-Fi antenna.
Wi-Fi module defective
Replace the Wi-Fi module.
Passport 12m Service Manual
Symptoms
Possible Cause
Corrective Action
Unable to connect to the
The Wi-Fi signal is unstable in
1. Verify that the network is available.
Wi-Fi network.
the operating area.
2. Check if the network type is correctly set. For example,
if LAN is used, set network type to LAN and connect the
patient monitor to the network; if WLAN is used, set the
network type to WLAN and connect the patient monitor
to the network.
3. Check that the SSID and password of the monitor are
consistent with those of the wireless AP.
4. Check for IP address conflicts. If any, set the IP
addresses correctly.
5. Check if Mindray recommended wireless AP is used. If
not, verify the AP effective transmission rate meets the
throughput requirements of the connected devices.
6. Verify the AP channel bandwidth is 20 MHz.
7. Verify where the monitor is located, the wireless AP
signal strength is no less than -65 dBm.
8. Verify where the monitor is located, the signal strength
of other Wi-Fi devices at the same channel is no greater
than -85 dBm.
9. Verify where the monitor is located, the signal strength
of other Wi-Fi devices of adjacent channels is no greater
than -50 dBm.
10. Verify that the recommended distance between the
monitor and other non-Wi-Fi wireless devices, including
wireless devices at the frequency of 2.4GHz, cellular
mobile communication networks, microwave ovens,
intercoms, cordless phones and electro-surgical units, is
no less than 20 cm.
The monitor's Wi-Fi antenna is
Properly attach the Wi-Fi antenna.
detached from or not
connected to the Wi-Fi module.
Wi-Fi antenna defective
Replace the Wi-Fi antenna.
Wi-Fi module defective
Replace the Wi-Fi module.
Main board defective
Replace the main board.
Passport 12m Service Manual
5-9
5.6.11 Wired Network Related Problems
Symptoms
Possible Cause
Corrective Action
Frequent dropouts and
Improper LAN cable
Check LAN cable connection. LAN cable should not be longer
network disconnects
connection
than 50 m.
Improper IP address
Check for IP address conflict. Reconfigure IP address.
configuration
The patient monitor is
Improper LAN cable
Check LAN cable connection. LAN cable should not be longer
connected to a LAN but
connection
than 50m.
cannot view other
More than 4 simultaneous
A patient monitor can only be viewed by 4 other patient
patients in the View
requests for viewing the
monitors simultaneously under the View Others mode.
Others mode
patient monitor
Requests in excess of that number will be ignored.
Incorrect IP configuration
Check for IP address conflict. Reconfigure IP address.
USB_Hub board failure
Replace the USB_Hub board.
5.6.12 Software Upgrade Problems
Symptoms
Possible Cause
Corrective Action
Bootstrap upgrade fails
Power failure or unintended
Replace the CPU board.
power off during bootstrap
upgrade
Program upgrade fails
Incorrect network
1.
connection
Verify the network connector, NOT the CIS connector, on
the patient monitor is being used.
2.
Verify the hub or switch operates properly. Verify the
network cables are the correct type and have been
connected properly.
Wrong upgrade package
Upgrade package should be .pkg files. Select package
has been downloaded
according to system requirement.
Incorrect IP address
Configure the IP address to ‘77.77.1.xx’ (xx can be any number
configuration
between 1 and 253). We recommend not to upgrade a program
when the patient monitor is connected to a network with
multiple PCs.
5-10
Passport 12m Service Manual
5.6.13 Technical Alarm Messages
Please refer to the Operator’s manual.
5.6.14 M51A Self Test Information
MPM module uses the integrative parameter board (ECG ASIC).
MPM Selftest Item
Test Value
Corrective Action
Not FF
Replace the module
DSP selftest information
7024 selftest information
2131 selftest information
ECG module selftest information
5.6.15 Device Integration Failures
Symptoms
Possible Cause
The ID adapter is not
displays nothing
after connection.
1.
Replace the ID adapter.
2.
Upgrade the ID adapter in [Factory Maintenance] menu
compatible with the external
to make the ID adapter match the corresponding external
device.
device. See 4.3.18.1 Device Connection and Setup for
The [Devices
Integrated] window
Corrective Action
more about the setup of the ID.
The serial port adapter cable is
not compatible with the
Replace the serial port adapter cable.
external device.
Wrong software version or
wrong protocol version of the
external device.
Generate the alarm:
The BeneLink module
[BeneLink Comm
application software is
Stop].
corrupted.
The BeneLink module
The patient monitor
application software is
has no response
corrupted.
when loading the ID
The kernel or the document
adapter.
system of the BeneLink module
Make sure the protocol version and software version are
supported by the BeneLink module.
Update or upgrade the software application of the BeneLink
module with the network upgrading tool.
Update or upgrade the software application of the BeneLink
module with the network upgrading tool.
Return the BeneLink module to Mindray for repair.
is damaged.
Passport 12m Service Manual
5-11
FOR YOUR NOTES
5-12
Passport 12m Service Manual
6 Repair and Disassembly
6.1 Tools
During disassembly and repair, the following tools may be required:
Phillips screwdrivers
Small flat-bladed screwdrivers
Tweezers
Needle-nose pliers
Hex nut driver or socket wrench
6.2 Preparations for Disassembly
Before disassembling the monitor:
Stop monitoring the patient, turn off the monitor and disconnect all the accessories and peripheral devices.
Disconnect the AC power source and take out both of the batteries.
Remove all the modules in the integral module rack. If the SMR is connected, disconnect the SMR from the monitor
and then remove all the modules in it.
WARNING
Before disassembling the monitor, be sure to eliminate any static electricity charges. When
disassembling the parts labeled with static-sensitive symbols, make sure you are wearing electrostatic
discharge protection such as an antistatic wristband or gloves to avoid damaging the equipment.
Carefully position cables and wires to avoid short circuits and/or pinched tubing when reassembling the
monitor.
When assembling the monitor, be sure to use the specified screws. If an incorrect screw is tightened by
force, the monitor may be damaged and the screw or the part may fall off during use and cause
unpredictable damage or human injury.
Be sure to follow the correct sequence when disassembling the monitor.
Be sure to disconnect all the cables before disassembling any parts. Take care not to damage any cables
or connectors.
Be sure to place the monitor face up when disassembling it. Otherwise, the screen or the knob may be
scratched or damaged.
Passport 12m Service Manual
6-1
6.3 Disassembling Procedure
6.3.1 Removing the Recorder
1.
Open the recorder door and unscrew the two M3×6 screws.
2.
Pull the two clips in the directions as indicated and pull out the recorder.
NOTE
6-2
Take care not to damage the connecting cables or connectors when pulling out the recorder.
Passport 12m Service Manual
3.
Unscrew the M3×6 screw and unplug the recorder grounding cable and the cable between the recorder and the
mother board.
4.
Pull the two clips backwards and remove the recorder driving board.
Passport 12m Service Manual
6-3
5.
Pull the press bar upwards about 1 mm and then unplug the flexible cable. Remove the cable that connects the
driving board and the button board. Unscrew the PT2×6 screw and remove the drive board’s grounding cable.
Then take out the recorder driving board.
6.
6-4
Unscrew the two PT2×6 screws and take out recorder’s button board.
Passport 12m Service Manual
7.
Unscrew the PT2×6 screw. Prize the thermal printhead a little using a small flat-bladed screwdriver to remove the
printhead.
Passport 12m Service Manual
6-5
6.3.2 Separating the Front and Rear Housing
1.
Remove the hook and then unscrew the four M3×12 screws, one of which can be seen only when the battery door
is openned.
NOTE
6-6
Exercise care when pulling the front housing out. Take care not to damage the cables and connectors.
Avoid pressing the knob on the table.
Passport 12m Service Manual
2.
Separate the front and rear housing and unplug the connecting cable between button board and main board as
well as the cable between the LCD and the main board.
Avoid pressing the knob
on the table.
Passport 12m Service Manual
6-7
6.3.3 Removing the Power Switch & LED Board
Unplug the connecting cable between power switch & LED board and the button board. Unscrew the two M3×6 screws
and remove the power switch & LED board.
6.3.4 Removing the Knob Encoder
1.
6-8
Pull out the knob encoder and unscrew the nut.
Passport 12m Service Manual
2.
Disconnect the cable that connects the knob encoder and the button board to remove the knob encoder.
6.3.5 Removing the Button Board
1.
Disconnect the cables from the button board to the alarm LED board, backlight board and touchscreen control
board.
Passport 12m Service Manual
6-9
2.
Remove the grounding spring and then remove the three PT3×8 screws and take out the button board.
NOTE
Do not forget the grounding spring when reassembling..
6.3.6 Removing the Touchscreen Control Board
Unplug the cables respectively from the touchscreen and button board to the touchscreen control board. Then, remove
the two M3×6 screws and remove the touchscreen control board.
6-10
Passport 12m Service Manual
6.3.7 Removing the Backlight Board
Unplug the cables respectively from the button board and the LCD to the backlight board. Remove the two M3×6
screws and remove the backlight board.
6.3.8 Removing the LCD
CAUTION
Do not touch the LCD.
Disassemble the LCD in an environment as dust-free as possible.
1.
Unscrew the eight M3×6 screws and remove the LCD with care. Do not touch the LCD surface and prevent it from
being contaminated by dust.
Passport 12m Service Manual
6-11
Do not touch the LCD
surface
2.
Unscrew the four M3×6 screws underneath the screen cover and then remove the LCD.
6.3.9 Removing the Alarm Lamp Board
After removing the LCD, disconnect the cable that connects the alarm lamp board and the button board, and then,
unscrew the two PT2×6 screws to remove the alarm lamp board.
6-12
Passport 12m Service Manual
6.3.10 Removing the Fan Assembly
Unplug the cable that connects the fan assembly and the mother board. Then, unscrew the four M3×6 screws and
remove the fan assembly.
6.3.11 Removing Battery Compartment Assembly
Unplug the cable that connects the battery compartment assembly and the mother board. Then, unscrew the three M3
×6 screws and take out the battery compartment assembly.
Passport 12m Service Manual
6-13
6.3.12 Removing the Integral Module Rack
1.
Disconnect the cable that connects the integral module rack and the mother board. Unscrew the five M3×8 screws
and remove the integral module rack.
6-14
Passport 12m Service Manual
2.
Disconnect the cable that connects the MPM module rack communication board and the 3-slot module rack
communication board. Release the two snaps and unplug the NiosII module on the 3-slot module rack.
NiosII module
3.
Unscrew the eight M3×6 screws and then remove the 3-slot module rack communication board and MPM module
rack communication board.
NOTE
Do not forget the grounding spring when reassembling..
Passport 12m Service Manual
3-slot module rack
MPM module rack
communication board
communication board
6-15
4.
Unscrew the hex nut assy using the hex nut driver. Then separate the washer, spring and contact screw from each
other.
Washer
Spring Leaf
Hex nut assembly
Contact screw
6.3.13 Removing the CF Card Assembly
1.
Unplug the cable that connects the CF card assembly and the mother board. Then, unscrew the two M3×6 screws
and remove the CF card assembly.
6-16
Passport 12m Service Manual
2.
Unscrew the two M3×6 screws and remove the CF card assembly with the shield.
NOTE
When reassembling the CF card assembly, be sure to install the CF card door first.
6.3.14 Removing the wireless AP assembly
1.
Disconnect the wireless AP cable. Then unscrew the two M3×6 screws to remove the wireless AP assembly.
Passport 12m Service Manual
6-17
2.
Unscrew the two M3×6 screws to remove the wireless AP.
6.3.15 Removing the Main Board
1.
Unplug all the cables on the mother board. The numbers beside the connectors indicates what device is connected
with the connector.
6-18
J4
Button board
J17
speaker
J5
Recorder
J19
LCD
J6
DVI interface board
J9
Wireless AP
J7
Battery interface board
J23
Fan
J10
CF card board
J25
3-slot module rack communication board
J12
power board
J18、J26
USB_Hub board
Passport 12m Service Manual
2.
Unscrew the 4 M3×6 screws and take out the main board assembly.
Ring
NOTE
Since the main board assembly is connected with the power module via a butt socket and the CPU
radiator may be adhered to it, the main board assembly should be removed with force. Take care
not to damage the butt socket.
Passport 12m Service Manual
6-19
3.
Unscrew the 4 M2.5×6 screws on the CPU board and vertically separate the CPU board and the mother board. Take
care not to damage the butt socket.
Butt socket to
power modul
CPU board
Button cell
6-20
Passport 12m Service Manual
6.3.16 Removing the Speaker
Unscrew the two M3×6 screws and remove the speaker.
6.3.17 Removing the Power Module Assembly
1.
Unscrew the four M3×12 screws and remove the power module assembly.
Passport 12m Service Manual
6-21
2.
Unscrew the three M3×12 screws and remove the power supply cover.
3.
Lift the power board with a small flat screwdriver. Then, turn it over.
6-22
Passport 12m Service Manual
4.
Unplug the cable between the AC input filter and the power board, then remove the power board.
Equipotential Pillar
NOTE
Since the power board may be adhered to the insulator, be careful not to damage the parts,
connectors and cables on the power board when prizing it.
6.3.18 Removing the Main Support
Unscrew the five M3×6 screws and disassemble the main support.
Note
Be sure to remove the power module first before removing the main support.
Passport 12m Service Manual
6-23
6.3.19 Removing the Interface Board Assembly
1.
Release the clip that locks the interface board and push it outwards.
2.
Open the interface board cover and unscrew the four M3×6 screws, then, unplug the interface board assembly.
3.
Unplug the cables on the interface board. Then unscrew the two M3×6 screws and remove the USB_Hub board.
6-24
Passport 12m Service Manual
4.
Remove the insulating pad from the interface board. Unscrew the two M3×6 screws on the DVI interface board.
Than unscrew the two screws beside the DVI socket , the two screws beside micro-D socket and the two M2.5×6
screws.
NOTE
Be careful not to damage the insulating pad between the DVI interface board and the USB_Hub board.
Replace, if damaged.
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6-25
6.4 Removing the SMR Assembly
1.
First remove the 4 screw covers and then unscrew the 4 M3×8 screws.
Right-side board
Left-side board
2.
Pull the left- and right-side boards outwards. Be sure to place the rubber ring in position when reassembling the
right-side board.
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Passport 12m Service Manual
3.
From the left side, remove the cable that connects the SMR interface board and the SMR communication board.
Then take out the SMR from its housing.
SMR
Housing
4.
Release the two clips and take out the SMR interface board. Be sure not to damage the snap slot on the left side.
5.
Remove the LED indicator, the light conductor and the cable that connects the SMR communication board and the
LED board.
Passport 12m Service Manual
6-27
6.
Release the clips and take out the Nios II module. Then unscrew the six M3×6 screws and remove the SMR
communication board.
6-28
Passport 12m Service Manual
7.
Use a socket wrench to unscrew the hexagon nut and countersunk external toothed lock washer assembly which
can be further separated into the washer, spring leaf and contact screw.
Spring leaf
Washer
Hexagon nut and countersunk external
toothed lock washer assembly
Passport 12m Service Manual
Contact screw
6-29
6.5 Disassembling Modules
WARNING
After reassembling a module, a patient leakage current test must be performed before it is used again
for patient monitoring.
6.5.1 Disassembling the BeneLink Module
1.
Remove the two contact screws and M3 spring washers on the back of the module with needle nose pliers.
Contact screws
6-30
Passport 12m Service Manual
2.
Unlock the snap lock by pressing it down about 1 mm with a flat screwdriver. At same time, push the snap plate
forward with your thumb until the snap lock separates from the module housing. Lift the front of the snap plate with the
flat screwdriver and remove it from the BeneLink module.
Snap plate
3.
Remove the M3×6 screw using a #1 Phillips screwdriver. Then, press down, in turn, the two clips that engage the
front panel. At same time, separate the front panel from the module’s outer housing.
4.
Remove the contact screws, the spanner, and the front cover by referring to steps 1 to 3 as described in section
6.5.1Disassembling the BeneLink Module.
Passport 12m Service Manual
6-31
5.
Take off the small cover board on one side of the rear cover. Then press the two clips about 1mm and take off the
housing.
6.
6-32
Release the three snaps to separate the two halves of the module side cover.
Passport 12m Service Manual
7.
Take off the cable between the USB board and the interface board.
8.
Take off the cable between the infrared communication board and the interface board to remove the infrared
board.
Passport 12m Service Manual
6-33
9.
6-34
Unclench the four clips with a tweezer to remove the interface board.
Passport 12m Service Manual
6.5.2 Disassembling the MPM Module
1.
Remove the contact screws and the spanner by referring to steps 1 to 3 as described in section 6.5.1 Disassembling
the BeneLink Module.
2.
Remove the two M3×6 screws. Then press down, in turn, the four clips that engage the front cover with a small
flat-bladed screwdriver. At the same time, pull off the rear cover.
Passport 12m Service Manual
6-35
3.
Disconnect the cable of the infrared communication board, and release the latching tab to remove the infrared
communication board.
Latching tab
4.
Disconnect the cables of the NIBP inflation pump and the relief valves from the parameter board. Snip off the cable
ties to remove the pump. Release the tabs to remove the valves.
6-36
Passport 12m Service Manual
5.
Remove the two M3×8 screws on the parameter board. Then pull off the parameter board rearward as shown
below.
Passport 12m Service Manual
6-37
6.
Remove the two M3×4 screws on the SpO2 board to separate the SpO2 board and the parameter board.
7.
Remove the three M3×8 screws to separate the front panel assembly from the chassis.
6-38
Passport 12m Service Manual
7 Parts
7.1 Introduction
This chapter contains the exploded views and parts lists of the main unit, satellite module rack and the parameter
modules of the patient monitor. It helps the engineers to identify the parts during disassembly of the patient monitor
and spare parts replacement.
Hardware architecture of the main unit is shown below:
NOTE
Please provide the FRU part number if you want to purchase the spare parts.
Passport 12m Service Manual
7-1
7.2 Main Unit
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Passport 12m front housing assembly (touchscreen)
/
1
2
Main unit
/
1
3
Phillips screw M3×12
/
4
7-2
Passport 12m Service Manual
7.3 Front housing Assembly
7.3.1 12.1” LCD with Touchscreen
Exploded View
Parts list
SN
Description
FRU part number
Qty
1
12.1" LCD TFT assembly of PP12m
115-021914-00
1
2
Front cover of Passport12m
115-030579-00
1
3
6301 alarmboard PCBA
051-000879-01
1
4
Alarm gasket
/
1
5
Knob spring
1
115-022497-00
6
monitor knob
7
Alarm light of PP8
043-003642-00
1
8
Overlay of Passport17m
049-000626-00
1
9
Power button
6802-20-66691-51
1
10
Power switch and indicator
6802-30-66680
1
11
Keyboard of Passport 17m
043-003610-00
1
Passport 12m Service Manual
1
7-3
12
T5 Keyboard(Touch screen/Optical Encoder)
115-004220-00
1
13
Encoder, Optical,16 pos. 5VDC Dip6
0000-10-10789
1
14
Phillips tapping screw PT2×6
/
3
SN
Description
FRU part number
Qty
15
Screw, Pan Head W/Washer Phillips M3×6
/
14
16
Sheet metal of front housing
/
1
/
Alarm light board cable
009-004019-00
1
/
Power switch cable
6802-20-66671
1
/
Touch screen control board to keyboard cable
6802-20-66672
1
7.3.2 12.1" LCD TFT assembly of PP12m
Exploded View
Parts list
SN
Description
FRU part number
Qty
1
metal plate of front cover (M12)
/
1
7-4
Passport 12m Service Manual
2
LCD Display screen TFT 12.1" 800*600 3.3V 400cd/m2
021-000160-00
1
3
cross pan head screw with washer GB9074.5 M3×8
/
4
4
Screen cover
/
1
5
Touchscreen strip 4
/
2
6
Touchscreen strip 3
/
2
7
Touch Screen 12.1"
0000-10-10799
1
SN
Description
FRU part number
Qty
8
Touchscreen strip 1
/
2
9
Touchscreen strip 2
/
2
10
Waterproof strip
/
1
11
Flat wire
009-005252-00
1
12
Conductive foam
/
1
13
Conductive foam, 9.5*3.2mm
/
1
14
Touch screen control board
6800-30-50082
1
15
Screw, Pan Head W/Washer Phillips M3×6
/
6
16
Spring, EMI
/
1
17
Invertor board (0623)
051-001820-00
1
7.4 Main Unit
7.4.1 Main Unit Assembly
Exploded View
Passport 12m Service Manual
7-5
Parts List
SN
Description
FRU part number
Qty
1
Integral module rack
/
1
2
Shield Reed
/
2
3
Rear housing assembly
801-6802-00017-00
1
4
Interface board assembly
115-015992-00
1
5
Power module assembly
044-000446-00
1
6
Phillips screw M3×12
/
4
7
Phillips screw M3×6
/
25
8
Interface board cover(New)
043-000059-01
1
9
CF card door
043-004097-00
1
10
TR6F recorder
801-6800-00080-00
1
11
Screw cap
/
2
12
Small fireproof sheet T5
047-014207-00
1
13
Printer mounting plate
6802-20-66718
1
14
Main support assembly
/
1
15
Shield foam 9.5*3.2mm
/
0.2
16
Battery compartment assembly
801-6802-00014-00
1
17
CPU heat conducting block
/
1
18
CPU heatsink
/
1
19
6802 new internal wireless AP assembly (ASUS)
115-024690-00
1
20
Master control board assembly
115-030586-00
1
21
Phillips screw M3×8
/
7
22
Fan assembly
801-6800-00033-00
1
7-6
Passport 12m Service Manual
7.4.2 Battery Compartment Assembly
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Battery compartment
/
1
2
Spring
/
2
3
Phillips screw M3×6
/
2
4
Phillips screw M3×10
/
1
5
Battery latch fixture
/
1
6
Battery latch
/
1
7
Fireproof sheet
/
1
8
Battery interface board (PN: 6802-30-66653)
801-6802-00014-00
1
9
Phillips screw M3×6
/
5
10
Conducting block 9.5×3.2
/
2
Passport 12m Service Manual
7-7
7.4.3 Power Module assembly
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Power supply compartment
044-000446-00
1
2
Grounding pole
/
1
3.
Retainer for power supply plugs
/
4
Flat washer, GB97.1 6
/
1
5
Spring washer, GB93 6
/
1
6
Waterproof strip for power socket
/
2
7
Stainless steel nut, GB6170 M6
/
1
8
AC input socket and cable
009-000255-00
1
9
power socket fixture
/
1
10
Phillips screw M3×6
/
2
11
Plastic double-ended bolt M3×15+6-8
/
1
12
Power board
6802-30-66651
1
13
Insulating plate
/
1
14
Power supply cover
6802-20-66720
1
15
Phillips screw M3×12
/
3
7-8
Passport 12m Service Manual
7.4.4 Interface Board Assembly (6802-30-66769)
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Interface board frame (new interface)
115-015992-00
1
2
Spring leaf
3
3
Phillips screw M2.5×6
2
4
USB_Hub board (no analog output, PN: 051-000020-01)
1
5
Interface board insulating plate
1
6
Phillips screw M3×6
4
7
DVI interface board (can support IABP)
1
Passport 12m Service Manual
7-9
7.4.5 Main Board Assembly
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Nut, GB6170 M2.5
115-030586-00
4
2
MCF547x CPU module (basic configuration/non-lead process,
1
PN: 6800-30-50058)
3
Screw M2.5x7+6-6
4
4
6802 mother board (full configuration, PN: 051-000223-00)
1
5
PCB handle
1
6
Phillips screw M2.5×6
4
7-10
Passport 12m Service Manual
7.4.6 Integral module rack
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Integral module rack
801-6802-00016-00
1
2
Waterproof strip 2 for integral module rack
/
1
3
Waterproof strip 1 for integral module rack
/
1
4
Infrared light filter
/
5
5
Contact screw
/
10
6
Contact spring
/
10
7
Spring leaf
/
10
8
Flat washer, GB96 3
/
10
9
M3 nut with spring washer
/
10
10
6802 3-slot communication board
051-000244-00
1
11
Rubber foot
/
1
12
Stud screw M3×7+6-6
/
5
13
Spring coil
/
2
14
Pan head screw M3×6
/
2
15
Stud screw M3×6+8-5
/
2
16
MPM module rack communication board
6800-30-50073
1
Passport 12m Service Manual
7-11
7.4.7 Main Support Assembly
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Conducting block 9.5×3.2
/
1
2
Phillips screw M3×6
/
5
3
Recorder mounting plate
6802-20-66718
1
4
Conducting block 9.5×3.2
/
1
5
Leaf
/
2
6
Main support
/
1
7
CPU radiator
/
1
8
CPU heat conductor
/
1
7-12
Passport 12m Service Manual
7.4.8 Rear Housing Assembly
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Handle waterproof pad
/
1
2
Handle
043-004099-00
1
/
2
3
Waterproof strip for the power supply
4
Battery door assembly
801-6802-00015-00
1
5
Rear housing
043-004091-00
1
6
Cushion
/
2
7
PhillipFlat washer, GB97.1 2.5
/
2
8
Phillips tapping screw PT2×6
/
4
9
Speaker and cables
020-000007-00
1
10
Phillips screw M3×6
/
1
11
Speaker cover
/
1
12
Cross pan head screw with washer M3×6
/
2
13
Tapping screw PT4×14
/
2
14
Flat washer, GB97.1 4
/
2
Passport 12m Service Manual
7-13
7.4.9 CF Card Assembly(115-001906-00)
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Card cover
043-004098-00
1
2
CF card board fixture
6802-20-66726
1
3
Leaf, 178S30(1EA=406mm)
801-6802-00082-00
2
4
Ejector for CF card socket (50pin)
801-6802-00003-00
1
5
Phillips screw M3×6
/
4
6
Phillips screw M2×4
/
4
7
CF card shield
042-000317-00
1
8
9211 CF card board (shield can be installed)
051-000104-00
1
9
Slot cover overlay
/
1
7-14
Passport 12m Service Manual
7.4.10 Internal Wireless AP Assembly
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Wireless AP holder for T5
042-000600-01
1
2
Thermal pad for wireless card
047-008023-00
2
3
Wireless router 150Mbps Wi-Fi
023-000505-00
1
4
Cover for wireless LAN (T5)
042-007522-00
1
5
Screw boss M3×7+8-6
/
2
6
Spring
/
2
7
Cross pan head screw with washer M3×6
/
4
8
Cable for AP wireless (6100)
009-002895-00
1
Passport 12m Service Manual
7-15
7.5 SMR
7.5.1 SMR Assembly
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Inside assembly
801-6800-00018-00
1
2
Hose
1
3
Interface board (PN: 6800-30-51154)
1
4
Rear housing
1
5
Side plate fixture
2
6
Phillips screw M3×8
4
7
Screw cap 2
4
8
Side plate, right
1
9
Rubber washer
1
10
Handle
1
11
Side plate, left
1
12
Cushion
4
7-16
Passport 12m Service Manual
7.5.2 SMR Inner Assembly
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Insulating plate
801-6800-00018-00
1
2
Torsion spring washer
2
3
Light conducting pole
1
4
Contact spring
16
5
Contact screw
16
6
Infrared light filter
8
7
SMR inside assembly
1
8
Spring leaf
16
9
Washer
16
10
Hex nut assy
16
11
Reinforced section steel
1
12
8-slot module rack communication board (PN:
1
6800-30-51153 )
13
stub screw M3×16+8-8
14
Rubber feet
6800-20-50233
10
15
spring washer GB93 3
/
1
Passport 12m Service Manual
2
7-17
SN
Description
FRU part number
Qty
16
Phillips screw M3×6
/
6
17
stud screw M3×10+8-8, coated with antirust nickel
/
1
18
Nios II module
/
1
7.6 MPM Module
MPM module applies the integrative parameter board (ECG ASIC).
Exploded View
Parts List
SN
Description
FRU part number
Qty
1
Plastic hex nut M3
/
2
M51A Multi-parameter module, 5-lead, standard (PN:
/
051-000976-01)
2
M51A Multi-parameter module, 5-lead, full (PN:
/
051-000977-01)
M51A Multi-parameter module, 12-lead, full (PN:
1
As configured
/
051-000978-01)
7-18
Passport 12m Service Manual
SN
Description
FRU part number
M51A Multi-parameter module, 5-lead, full, IBP, Masimo (PN:
/
Qty
051-001037-01)
Cable for infrared Communication board
/
3
Silicone tube, 3/32 in. × 7/32 in. × 100ft
/
1.65 inch
4
Plastic hex screw stud, M3×12
/
2
5
Insulation sheet for SpO2 board
/
1
9008 V2.0 SpO2 board (PN: 051-000943-00)
/
Nellcor SpO2 board (PN: 0671-00-0102-01)
/
Masimo, MS-2013, SpO2 board (PN: 040-001149-00)
/
7
Phillips screw M3×4
/
2
8
Waterproof seal 02
/
1
9
Cross pan head screw with washer M3×8
/
5
10
Holder
/
1
New MPM front panel assembly, Nellcor SpO2
115-011210-00
New MPM front panel assembly, Nellcor SpO2 Without IBP
115-011213-00
6
11
New MPM front panel assembly, Masimo2013 SpO2 Without
IBP
1
As configured
115-011214-00
1
As configured
New MPM front panel assembly, Masimo2013 SpO2
15-011211-00
12
Label
/
1
13
NIBP pump
14
Cable tie, CHS-4×150mm
/
2
15
M3 nut with washer
/
2
New M51A Infrared communication board
/
1
New M51A Infrared communication board, no IBP
/
As configured
17
Screw
/
2
18
Pump cushion
/
1
19
Tee connector, White, Nylon
/
4
20
Inline Filter
/
2
21
630F Reducer
/
1
22
Valve
/
1
23
Flat head screw, Phillips M3×6
/
2
24
Locking clip
/
2
25
Screw
/
2
26
Spring Washer
/
2
27
Infrared lens
/
1
28
Barcode label
29
Patent label
30
Rear cover
/
1
16
Passport 12m Service Manual
7-19
7.7 Replaceable Parts
To replace the parts, please refer to Chapter 5 Repair and Disassembly and the exploded views above.
NOTE
Here is a list of the most commonly replaced parts. If you need more parts, please contact our
Customer Service Department.
7.7.1 Main Unit
FRU
Description
Front housing assembly
051-001820-00
022-000014-00 or
022-000001-00
Backlight board
TPI inverter
009-005252-00
Flat Cable Of AU Screen
021-000160-00
LCD screen (G121STN01.0)
0000-10-10799
Touchscreen 12.1”
0000-10-10749(optional) Touchscreen 12.1”
6800-30-50082
6800-30-51095 (optional)
Touchscreen control board
Touchscreen control board
(should be used in connection with the optional touchscreen 0000-10-10749)
043-003546-00
Passport 12m front housing
115-004220-00
T5 button board (touch screen, optical encoder)
051-000879-01
Alarm LED board
115-022497-00
Encoder assembly
6802-30-66680
Power switch & LED board
6802-20-66732
Connecting cable between converter and keypad (Sharp)
6802-20-66673
Cable connecting the inverter and the button board
6802-20-66650
Flat cable connecting the LCD and the mother board
009-004019-00
Alarm lamp board
6802-20-66671
Cable connecting the power switch & LED board and button board
FRU
Description
Front housing assembly (continued)
6802-20-66672
Cable between the touchscreen control board and the button board
Main unit
043-000184-00
Recorder cover
6802-20-66665
Cable connecting the recorder and the mother board
6802-20-66666
Cable connecting the CF card and the mother board
6802-20-66684
Cable connecting the button board and the mother board
043-004115-00
Interface board cover
7-20
Passport 12m Service Manual
6802-20-66717
Main support
6802-20-66718
Recorder fixing plate
6802-30-66763
Battery compartment assembly
6802-30-66653
Battery interface board
6802-20-66799
Cable connecting the Integral module rack and the mother board
6802-30-66767
Master control board assembly
6802-30-66769
Interface assembly
115-001906-00
6802 CF card assembly (211 driving board)
023-000845-00
023-000846-00
CF card
6802-30-66768
Fan assembly
6802-20-66668
Speaker and cables
115-001290-00
TR6F recorder
6802-30-66770
Power module assembly
6802-30-66651
Power board
6800-30-50073
MPM module rack communication board
6800-30-50075
NiosII module
6802-20-66669
Cable connecting the main unit and the infrared communication board
051-000244-00
6802 3-slot module rack communication board
049-000626-00
Passport 17m key pad
049-000680-00
Passport 17m key pad(French)
6802-30-66766
Rear housing assembly
6800-20-50672
Cable connecting the main board and the DIV interface board
6800-20-50673
Cable connecting the main board and the USB_Hub board
6802-20-66664
Cable connecting the DVI interface board and the mother board
6802-20-66675
Cable connecting USB_Hub board and the mother board
6802-30-66659
USB Hub board
FRU
Description
Main unit (continued)
6802-30-66657 or
DVI interface board or
051-000019-00
DVI interface board (can support IABP)
6800-20-51104
Cable connecting the SMR receptacle interface board and infrared communication board
009-000248-00
Cable connecting the inverter and button board
009-004546-00
Cable connecting the LED backlight board and screen
009-005252-00
Flat connection cable for AU screen
Passport 12m Service Manual
7-21
7.7.2 SMR
FRU
Description
6800-30-50075
NiosII module
6800-30-50078
SMR communication board
6800-30-50080
SMR interface board
6800-30-50667
SMR indicating lamp assembly
043-004118-00
SMR inside assembly
043-004120-00
SMR rear housing
043-004051-00
SMR handle
7.7.3 Parameter Modules and Cables
FRU
Description
115-015012-00
BIS Module
115-013335-00
SpO2 module(Masimo MS-2013)
6800-30-50488
RM module
6800-30-50137
Mindray sidestream CO2 module (M02B, 2 slots)
115-020189-00
Mindray sidestream CO2 module (M02C, 1 slot)
6800-30-50501
AG module (with O2/BIS)
6800-30-50502
AG module (with O2)
115-029852-00
C.O. module
115-029851-00
IBP module
6800-30-50558
ORIDION CO2 module
115-003480-00
CCO/SvO2 module
115-007273-00
ScvO2 module
115-007276-00
BeneLink module
115-022715-00
MPM-2 module(Masimo SpO2 (MS-2013), 3/5lead,FDA)
115-022716-00
MPM3 module(Nellcor SpO2, 3/5lead, FDA)
115-022718-00
MPM5 module (Masimo SpO2 (MS-2013), 12-lead, FDA)
115-022719-00
MPM6 module(Nellcor SpO2, 12lead, FDA)
115-030471-00
Assistant inset box
6800-30-50132
Nellcor SpO2 flexible cable kit
6800-30-50130
Masimo SpO2 flexible cable kit
6800-20-50662
Air pump cable
6800-20-50663
Fast-release valve cable
6800-20-50664
Slow-release valve cable
6800-20-50674
Cable from ICG module to infrared communication board
6800-20-50683
Mindray CO2 infrared communication cable
7-22
Passport 12m Service Manual
FRU
Description
6800-20-50306
AG module cable
6800-21-50310
BIS interface cable
6800-21-50311
CO interface cable
6800-21-50312
IBP interface cable
6800-20-50316
RM infrared detection board cable
6800-20-50160
Module button board cable
040-000125-00
Patient Interface Cable (BIS module service part)
040-000674-00
For service only, BISx Kit (186-0199-MR)
040-000675-00
For service only, BISx4 Kit (186-1030-MR)
040-000676-00
For service only, BISx Host Cable (186-0201-MR)
009-001770-00
RJ45 connecting cable
009-001767-00
Serial port adapting cable, type A
009-001768-00
Serial port adapting cable, type B
009-001769-00
Serial port adapting cable, type C
009-001765-00
Cable, Infrared Board to Interface Board
009-001254-00
AP&CVP socket with signal cable
009-001255-00
ScvO2 socket with signal cable
Passport 12m Service Manual
7-23
FOR YOUR NOTES
7-24
Passport 12m Service Manual
8 Upgrade
8.1 Introduction
You can upgrade parameter modules, functional assemblies and system software by connecting the patient monitor
to a PC running the System Update Tool.
NOTE
If you have to disassemble the patient monitor for software upgrade, be sure to eliminate static
charges before disassembling the equipment. When disassembling any part labeled with an ESD
warning symbol, make sure you are wearing electrostatic discharge protection such as an antistatic
wristband or gloves to avoid damaging the equipment.
Properly connect and route the cables and wires when reassembling the equipment to avoid pinched
hoses and electrical short circuits.
Use specified screws to assemble the equipment. If the incorrect screws are forcefully tightened, the
equipment may be damaged and the screws or part may fall off during use, causing unpredictable
equipment damage or human injury.
Follow correct sequence to disassemble the equipment. Otherwise, the equipment may be
permanently damaged.
Disconnect all cables before disassembling any parts. Be careful not to damage any cables or
connectors.
Passport 12m Service Manual
8-1
8.2 Upgrading Parameter Modules
You can upgrade the following parameter modules:
Parameter
PN
Description
Remark
115-022715-00
MPM-2 module(Masimo MS-2013, 3/5lead, FDA)
/
MPM
115-022716-00
MPM3 module(Nellcor SpO2, 3/5lead, FDA)
/
module
115-022718-00
MPM5 module (Masimo MS-2013, 12-lead, FDA)
/
115-022719-00
MPM6 module(Nellcor SpO2, 12lead, FDA)
/
IBP module
6800-30-50850
IBP module upgrade package (without accessories)
/
C.O. module
6800-30-50849
C.O. module upgrade package (without accessories)
/
M02B CO2 module upgrade package (for adult and
Sidestream (2
pediatric patients, with accessories)
slots)
M02B CO2 module upgrade package (for neonatal patient,
Sidestream (2
with accessories)
slots)
Oridion CO2 module upgrade package (with accessories)
Microstream
module
6800-30-50139
CO2 module
6800-30-50141
6800-30-50820
6800-30-50841
AG module
6800-30-50842
6800-30-50427
BIS module
RM module
CCO/SvO2
module
ScvO2
Module
AG module upgrade package (with O2, BIS, and
accessories
AG module upgrade package (with O2 and accessories
BIS module upgrade package (for pediatric patients, with
accessories)
/
/
/
6800-30-50880
BIS module upgrade package (with accessories)
/
6800-30-50853
RM module upgrade package (with accessories)
/
801-6800-00104-00
CCO/SvO2 module upgrade package
/
115-007590-00
ScvO2 function upgrade kit
/
You can insert and remove parameter modules during patient monitoring. Refer to the Operators’ Manual for the use
of parameter modules.
8-2
Passport 12m Service Manual
8.3 Upgrading Functional Assemblies
You can upgrade the following functional assemblies:
Functional
assembly
SMR
Wireless
network
Recorder
Analog
output
PN
Description
Remark
6800-30-50641
SMR kit
/
801-6802-00031-00
6802 wireless network upgrade kit
TR6F-30-67318
Recorder upgrade kit
/
801-6802-00006-00
DVI interface board (FRU)
/
Internal AP,
for fully configured patient monitor
The patient monitor can be connected to a network through wireless AP. Authorized personnel are required to
connect and set up the wireless network, and then carry out the performance test.
8.3.1 Upgrading SMR
The SMR can be connected to the patient monitor through the SMR connector via a powered USB cable.
Refer to the Operator’s Manual for details.
8.4 Upgrading Software
Software upgrade must be performed by Mindray, NA authorized service provider. Call Service Dispatch 1 800
288-2121 ext: 7875.
Passport 12m Service Manual
8-3
FOR YOUR NOTES
8-4
Passport 12m Service Manual
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. Please 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 Power Cord Plug
Test Item
Acceptance Criteria
The power plug pins
No broken or bent pin. No discolored pins.
The power
The plug body
No physical damage to the plug body.
plug
The strain relief
No physical damage to the strain relief. No plug warmth for device in use.
The power plug
No loose connections.
No physical damage to the cord. No deterioration to the cord.
The power cord
For devices with detachable power cords, inspect the connection at the device also.
For devices with non-detachable power cords, inspect the strain relief at the device.
A.2 Device Enclosure and Accessories
A.2.1 Visual Inspection
Test Item
Acceptance Criteria
No physical damage to the enclosure and accessories.
The enclosure and accessories
No physical damage to meters, switches, connectors, etc.
No residue of fluid spillage (e.g., water, coffee, chemicals, etc.).
No loose or missing parts (e.g., knobs, dials, terminals, etc.).
Passport 12m Service Manual
A-1
A.2.2 Contextual Inspection
Test Item
Acceptance Criteria
No unusual noises (e.g., a rattle inside the case).
The enclosure and accessories
No unusual smells (e.g., burning or smoky smells, particularly from ventilation holes).
No taped notes that may suggest device deficiencies or operator concerns.
A.3 Device Labeling
Check the labels provided by the manufacturer or the healthcare facility are present and legible.
Main unit label
Integrated warning labels
A.4 Scheduled Electrical Safety Inspection
For scheduled electrical safety inspection, perform all the test items listed in A.6 ELECTRICAL SAFETY INSPECTION TEST.
A.5 Electrical Safety Inspection after Repair
The following table specifies test items to be performed after the equipment is repaired. Refer to A.6 ELECTRICAL
SAFETY INSPECTION TEST for the description of the test items.
Repair with main unit not disassembled
Repair with
When neither power supply PCBA nor
main unit
patient electrically-connected PCBA is
disassembled
repaired or replaced
When power supply PCBA is repaired or
Test items: 1, 2, 3
Test items: 1, 2, 3, 4
Test items: 1, 2, 3, 4, 5
replaced
When patient electrically-connected PCBA is
Test items: 1, 2, 3, 4, 6, 7, 8
repaired or replaced
When both power supply PCBA and patient
Test items: 1, 2, 3, 4, 5, 6, 7, 8
electrically- connected PCBA are repaired or
replaced
A-2
Passport 12m Service Manual
A.6 ELECTRICAL SAFETY INSPECTION TEST
Inspection and Testing
Limit
1
Power Cord Plug
2
Device Enclosure and Accessories
/
3
Device Labeling
/
4
Protective Earth Resistance
Max 0.2 Ω
5
Earth Leakage
Normal condition(NC)
Max:
NC: 300μA(refer to UL60601-1)
6
Patient Leakage Current
Single Fault condition(SFC)
SFC: 1000μA
Normal condition(NC)
Max:
CF applied part:
NC:10μA, SFC: 50μA
Single Fault condition(SFC)
BF applied part:
NC:100μA, SFC: 500μA
7
Mains on Applied Part Leakage
Max:
CF applied part: 50μA
BF applied part: 5000μA
8
Patient Auxiliary Current
Normal condition(NC)
Max:
CF applied part:
NC:10μA, SFC: 50μA
BF applied part:
NC:100μA, SFC: 500μA
Passport 12m Service Manual
A-3
FOR YOUR NOTES
A-4
Passport 12m Service Manual
P/N 046-005122-00
Version: V2.0
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