BeneVision N17N15N12 - Service Manual - V4.0 - EN
BeneVision N17N15N12 - Service Manual - V4.0 - EN
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.
Revision History
This manual has a revision number. This revision number changes whenever the manual is updated due to
software or technical specification change. Contents of this manual are subject to change without prior
notice.
© 2016 -2017 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
I
Preface
Manual Purpose
This manual provides detailed information about the assembling, dissembling, testing and
troubleshooting of the equipment to support effective troubleshooting and repair. It is not intended to be
a comprehensive, in-depth explanation of the product architecture or technical implementation.
Observance of the manual is a prerequisite for proper equipment maintenance and prevents equipment
damage and personnel injury.
Intended Audience
This manual is for biomedical engineers, authorized technicians or service representatives responsible for
troubleshooting, repairing and maintaining the monitors
Passwords
A password may be required to access different modes. The passwords are listed below:
II
Contents
1 Safety ...................................................................................................................................................... 1-1
1.1 Safety Information................................................................................................................................................................ 1-1
1.1.1 Dangers ...................................................................................................................................................................... 1-1
1.1.2 Warnings .................................................................................................................................................................... 1-2
1.1.3 Cautions ..................................................................................................................................................................... 1-2
1.1.4 Notes ........................................................................................................................................................................... 1-3
1.2 Equipment Symbols ............................................................................................................................................................ 1-3
1
4.2.1 Visual Inspection ..................................................................................................................................................... 4-3
4.2.2 NIBP Tests................................................................................................................................................................... 4-4
4.2.3 Sidestream and Microstream CO2 Tests .......................................................................................................... 4-6
4.2.4 AG Tests ...................................................................................................................................................................... 4-9
4.3 Power On Test ......................................................................................................................................................................4-11
4.4 Module Performance Tests .............................................................................................................................................. 4-11
4.4.1 ECG Tests ..................................................................................................................................................................4-11
4.4.2 Resp Performance Test........................................................................................................................................ 4-12
4.4.3 SpO2 Test ..................................................................................................................................................................4-12
4.4.4 NIBP Tests.................................................................................................................................................................4-13
4.4.5 Temp Test .................................................................................................................................................................4-13
4.4.6 IBP Tests ....................................................................................................................................................................4-13
4.4.7 C.O. Test ....................................................................................................................................................................4-15
4.4.8 Mainstream CO2 Tests .......................................................................................................................................... 4-15
4.4.9 Sidestream and Microstream CO2 Tests ........................................................................................................ 4-16
4.4.10 AG Tests ..................................................................................................................................................................4-16
4.4.11 EEG Test ..................................................................................................................................................................4-17
4.4.12 BIS Test ...................................................................................................................................................................4-18
4.4.13 RM Test ...................................................................................................................................................................4-19
4.4.14 CCO/SvO2 Tests .................................................................................................................................................... 4-20
4.4.15 PiCCO Test .............................................................................................................................................................4-21
4.4.16 NMT Tests ..............................................................................................................................................................4-23
4.5 Nurse Call Relay Performance Test ............................................................................................................................... 4-24
4.6 Analog Output Performance Test ................................................................................................................................. 4-25
4.7 Electrical Safety Tests.........................................................................................................................................................4-25
4.8 Recorder Check ...................................................................................................................................................................4-26
4.9 Network Print Test ..............................................................................................................................................................4-26
4.9.1 Device Connection and Setup ......................................................................................................................... 4-26
4.10 Device Integration Check .............................................................................................................................................. 4-27
4.11 Battery Check.....................................................................................................................................................................4-27
4.12 Mounting Check ...............................................................................................................................................................4-27
4.12.1 Safety check .........................................................................................................................................................4-27
4.12.2 Overall Test and Check of Installed System .............................................................................................. 4-27
4.13 Factory Maintenance ...................................................................................................................................................... 4-28
4.13.1 Accessing Factory Maintenance Menu....................................................................................................... 4-28
4.13.2 Monitor Information ......................................................................................................................................... 4-28
4.13.3 Production Test ................................................................................................................................................... 4-29
4.13.4 Setup.......................................................................................................................................................................4-29
4.13.5 Debug.....................................................................................................................................................................4-30
4.13.6 Power Info .............................................................................................................................................................4-30
4.13.7 ClinicalData ..........................................................................................................................................................4-30
4.13.8 Transferring Clinical Data ................................................................................................................................ 4-31
4.13.9 Software Version ................................................................................................................................................. 4-31
4.13.10 Monitor Information ....................................................................................................................................... 4-31
2
5 Troubleshooting .................................................................................................................................... 5-1
5.1 Introduction............................................................................................................................................................................ 5-1
5.2 Part Replacement ................................................................................................................................................................. 5-1
5.3 Check before Powering on the Monitor ....................................................................................................................... 5-1
5.4 Software Version Check ...................................................................................................................................................... 5-2
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 ........................................................................................................................................................ 5-3
5.6.3 Module Rack Failures ............................................................................................................................................. 5-4
5.6.4 Alarm Failures........................................................................................................................................................... 5-5
5.6.5 Recorder Failures..................................................................................................................................................... 5-6
5.6.6 Output Interface Failures ..................................................................................................................................... 5-6
5.6.7 Power Supply Failures ........................................................................................................................................... 5-7
5.6.8 Network Related Problems ................................................................................................................................. 5-8
5.6.9 Software Upgrade Problems .............................................................................................................................. 5-9
5.6.10 Device Integration Failures ............................................................................................................................. 5-10
3
7.5 Further Disassembly of the Rear Case Assembly ...................................................................................................... 7-9
7.5.1 Removing the Recorder........................................................................................................................................ 7-9
7.5.2 Further Disassembly of the Recorder ............................................................................................................ 7-10
7.5.3 Removing the MPAN Board .............................................................................................................................. 7-11
7.5.4 Removing the Wi-Fi Module ............................................................................................................................. 7-12
7.5.5 Removing the Internal Module Rack Assembly......................................................................................... 7-13
7.5.6 Removing the Main Support Assembly........................................................................................................ 7-17
7.5.7 Removing the iView Board Assembly (N17 Series)................................................................................... 7-21
7.5.8 Removing the Independent Display Board Assembly (N17 Series) ................................................... 7-23
7.5.9 Removing the Handle ......................................................................................................................................... 7-24
7.6 Further Disassembly of the Base Assembly .............................................................................................................. 7-25
7.7 Disassembling the Module Rack ................................................................................................................................... 7-26
7.8 Disassembling the M51C Module................................................................................................................................. 7-28
4
8.5 M51C Module .......................................................................................................................................................................8-35
5
FOR YOUR NOTES
6
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 to ensure that you get the most from your
product.
1.1.1 Dangers
There are no dangers that refer to the product in general. Specific “Danger” statements may be given in
the respective sections of this manual.
1-1
1.1.2 Warnings
WARNING
All installation operations, expansions, changes, modifications and repairs of this product are
conducted by Mindray authorized personnel.
There is high voltage inside the equipment. Never disassemble the equipment before it is
disconnected from the AC power source.
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, 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.
Protect the equipment from damage caused by drop, impact, strong vibration or other
mechanical force during servicing.
1-2
1.1.4 Notes
NOTE
1-3
FOR YOUR NOTES
1-4
2 Operation Theory
2.1 Overview
As a bedside workstation for multi-parameter monitoring, the N series can provide the complete patient
management, abundant physiological parameter monitoring and physiological alarm functions, as well
the powerful data review function and the flexible wired and wireless network configuration and
application capabilities. The third-party application can be accessed easily through the iView application,
meeting the increasingly common information requirements of hospitals. The provided series of CAA
applications can help doctors to make auxiliary diagnosis for patients. Meanwhile, the N series provide the
hospital management personnel with more excellent monitor management applications, rendering
assistance in fixing the efficiency and quality problems during monitor equipment management of
hospitals.
The N series provide the product models with display screens of different sizes according to the demand
of clinical application. In addition to touch screen operations, the user can use the mouse and keyboard to
operate the monitor. The N series can connect to multiple display screens to function as mirror screens or
extension screens.
The series of products are compatible with the BeneView T series plug-in modules and related accessory
products. They can work together with the TDS to implement the intra-hospital transfer application of
patients.
In comparison with the BeneView T series products, the N series boast better human-computer
interaction design and clinical applicability, more complete IT solution capability of hospitals, and more
abundant CDS applications.
The N12 main unit uses the 12.1” TFT WXGA display screen.
The N15 main unit uses the 15.6” TFT FHD display screen.
The N17 main unit uses the 18.5”TFT FHD display screen.
All of them use the touch screen as an input device and can extend the mouse, keyboard and
remote control.
An internal module rack is integrated, with 4 slots (N12) or 6 slots (N15/N17).
The MPAN and WiFi modules are optional.
The built-in recorder is optional.
2-1
The N15/N17 can connect to the external module rack and TDS; the N12 can connect to the
TDS.
LCD
Alarm lamp Power switch
TP control
board board
board
Front
shell
Back
shell Speaker
WiFi module MPAN module
(Optional) (Optional)
Independent display board
DVI (N17 Optional)
AC/DC AC/DC
module interface
Recorder
(Optional)
Battery interface
2*USB 2*USB DVI RJ45 board Battery
(N12/N12C)
Bottom
shell Battery interface
board Battery
(N15/N17)
2-2
2.2.1 Main Control Board
There are the main control CPU, program memory, data memory, system configuration memory, system
FPGA, WiFi module (optional), power management MCU, battery charging circuit, and DC-DC circuit on
the main control board. The internal interface and external interfaces are also provided on the board. The
internal interface is an interface between the recorder, internal module rack COM board, AC-DC, and the
battery. The external interfaces refer to the DVI display interface, USB interface, and Ethernet interface.
Internal Module
MPAN Module Rack communication SPI MMC WiFi Main
board (optional)
E2ROM(funnct
Control
Nursecall ion cfg) DDR3 board
interface
RTC I2C
SMR Program
MMC
Interface Memory
Alarm light
controller
Data Memory
Touch- I2C
Touch panel
controller
SPI E2ROM
Photo Main Processor
senseor
USB USB hub USB 4*port
Independent
Audio RMII1 PHY display
Speaker board/iView
codec/AMP
FPGA
LCDC LCD
Power key board Power M0 UART (N15/N17)
DVI DVI
transfer interface
RJ-45 PHY
Back light
driver
2-3
2.2.3 Power Architecture
Power switch Photo Alarm lamp
Led driver board
LCD&TP board senseor
+5V/+3.3V
+3.3V_1 +3.3V
M0
+12V +3.3V_2
DC/DC MPAN module
ON/OFF
LDO DC/DC
Battery
+5V Independent display
board
+5V +12V
Recorder
The AC/DC power module outputs 15V to the main control board, and 3.3V, 5V and 12V can be generated
through the internal DC-DC conversion circuit in the main control board to provide a power supply to
other modules or boards in the main unit. The battery charging circuit is powered by 15V, and the AC
power supply and battery power supply can be switched according to AC on-line detection.
The +12V power supply is provided to the power supply, including the external module rack, and the
DC-DC isolation design is implemented at the module end.
The iVIew assembly uses the power rail Vbus, which is the switching output between the AC-DC output
and battery and aims to avoid abnormal power failure of the iView module and running exception of the
Windows OS running on other modules due to an unexpected power failure of the AC power supply. The
battery supports the main unit to stop the iView module in the normal power-off mode. In the case of
battery power supply, the iView module cannot start.
2-4
2.2.4 Independent Display Board (for the N17 Only)
It is used to connect the main unit to a display and extend the main screen display. It adopts the DVI
interface. Moreover, the external display with a touch screen can be supported through the USB interface
of the main unit. At present, the supported display with a touch screen is Elo 1919LM.
Data storage
The monitoring parameters are collected and analyzed through the module, and then forwarded to the
system software through the internal or external module rack. The system software displays the waveform,
numerical value and alarm information, and the data, alarm information and numerical value are also
stored in the internal data memory at the same time. Meanwhile, they can also be sent to the central
station or other monitors through the wired or wireless network.
2-5
FOR YOUR NOTES
2-6
3 WLAN Installation
3.1 Introduction
This chapter describes how to install Mindray patient monitors using WLAN.
Mindray/agent
service personnel A2 Communicate with the
hospital about network
requirements and ask the
hospital to perform
corresponding setting and
adjustment
A3 Do site survey
Pass or fail
Pass
3-1
3.2.1 List of outputs
Action Output Requirements Template
A0 Wireless Network requirements Determine requirements for Wireless Network
for Mindray patient monitors deployment of the wireless network for Requirement Table in 3.3
Mindray patient monitors. Network Requirements
A3 Network acceptance report Confirm that the customer network Wireless Network
meets requirements of Mindray patient Acceptance Table in 3.4.3
monitors by means of questionnaire Network Verification
and measurement. Process
A5 Installation confirmation report Confirm the actual operation of the Patient Monitor
Mindray patient monitors after Installation Confirmation
installation. Table in 3.5 Network
Coverage Assessment
with Patient Monitors
If the hospital plans to build a new WLAN for the Mindray patient monitors, make sure that there is at
least one idle Wi-Fi channel that is not in use. Otherwise, you can’t make co-channel interference meet
Mindray patient monitors’ requirement after the new WLAN is built. The installation process is illustrated
as follows:
Mindray/agent
service personnel A2 Do site survey and
design network
A4 Install network
3-2
Action Output Requirements Template
NOTE
Network design and deployment project needs much more complex process, you need
professional IT engneer ’s help to finish the job. This document does not include these
contents.
3-3
No. Item Content of Requirements
2 802.11 protocol WLAN can't use protocols that Mindray patient monitor can’t
support, e.g 802.11ac
3 Security mode WLAN can't use Security mode that Mindray patient monitor
can’t support.
Using WPA2-Enterprise or WPA2-PSK is recommended. Use a long
password and change it frequently. If the hospital network
supports WPA2-Enterprise, using WPA2-Enterprise can achieve
higher security.
4 Dedicated VLAN The patient monitors need to work on a dedicated VLAN.
Using VLAN can minimize Broadcast or multicast data which can
affect patient monitors’ stability.
Important settings
1 DHCP The DHCP server reserves a sufficient number of IP addresses to
ensure that the patient monitors can obtain an IP address.
2 IGMP snooping If patient monitors use multicast, enable IGMP snooping
3 Multicast If patient monitors use multicast, the multicast function of
network should be enabled.
4 Beacon & DTIM AP DTIM = 1, Beacon = 100ms
5 Service port Refer to Mindray Patient Monitoring Network Whitepaper;
patient monitors need some certain TCP/UDP ports to be opened
Wireless network survey tool, we suggest to use professional survey tool such as tamograph,
Wirelessmon or other professional network survey tool.
NOTE
The personnel who implement the Wi-Fi network survey should be well trained about Wi-Fi. If
professional network engineers are not available, please ask some third party for help.
3-4
3.4.2 Wi-Fi Signal Calibration
Before a wireless network survey tool (running on laptop computer) is used to test network coverage,
follow this procedure to calibrate the RSSI of wireless network survey tool with a patient monitor
1. Keep the patient monitor and wireless network survey tool close. The distance between them is not
greater than 30cm and the distance from human body is above 50 cm.
2. Move the patient monitor and Wireless network survey tool at the same time (keep the previous
distance).
3. When the patient monitor reads the following RSSI values: -50 dBm, -60 dBm, -70 dBm and -80 dBm,
record the RSSI values read by Wireless network survey tool.
4. Calibrate the RSSI of Wireless network survey tool to patient monitor when do site survey (the RSSI of
Patient monitor is the benchmark to wireless coverage).
When in test, the Wi-Fi network SSID broadcast needs to be enabled to ensure that the Wi-Fi SSID can be
scanned.
3-5
No. Item Content of Verification Method Check Results
Requirements
3 Ping The mean delay of PC or cell Service person performs the
delay phone with normal Wi-Fi test:
module is smaller than 1. Connect PC or cell phone
100ms and The packet lost with normal Wi-Fi module to
rate shall be less than 1%. AP.
2. Connect another PC to the
LAN port where the central
monitoring system is
connected to.
3. Run the command” “ping
–t –l 32 –w 1000
IPaddress-of -cellphone” for
10 minutes.
4. Run“ ctrl+c”.
Requirements of AP capability
1 AP The anticipated number of Service personnel get the AP
capabili devices connecting to one model from related hospital
ty AP must be lower than 50% people or observe directly.
of the AP capability. For According to the model, get
example, In the coverage of the data sheet of AP to make
one AP, the typical number sure the capability.
of devices connected to this
AP is 16, then the
announced number of
devices that can connect to
AP simultaneously must be
more than 32.
The AP can create several
SSIDs.
2 Device The maximum number of Check with hospital IT if this
density devices connected to one AP requirement is met or not.
simultaneously is 12
(including patient monitors
and other devices).
WLAN features
1 AP Set the channel width to Check with hospital IT if this
channel 20MHz, don’t use HT40 or requirement is met or not.
width even HT80.
2 802.11 WLAN can't use protocols Check with hospital IT if this
protoco that Mindray patient requirement is met or not.
l monitor can’t support, e.g
802.11ac
3-6
No. Item Content of Verification Method Check Results
Requirements
3 Security WLAN can't use Security Check with hospital IT if this
mode mode that Mindray patient requirement is met or not.
monitor can’t support.
Using WPA2-Enterprise or
WPA2-PSK is recommended.
Use a long password and
change it frequently. If the
hospital network supports
WPA2-Enterprise, using
WPA2-Enterprise can
achieve higher security.
4 Dedicat The patient monitors need Check with hospital IT if this
ed to work on a dedicated requirement is met or not.
VLAN VLAN.
Using VLAN can minimize
Broadcast or multicast data
which can affect patient
monitors’ stability.
Important settings
1 DHCP The DHCP server reserves a Check with hospital IT if this
sufficient number of IP requirement is met or not.
addresses to ensure that the
patient monitors can obtain
an IP address.
2 IGMP If patient monitors use Check with hospital IT if this
snoopin multicast, enable IGMP requirement is met or not.
g snooping
3 Multica If patient monitors use Check with hospital IT if this
st multicast. The multicast requirement is met or not.
function of network should
be enabled.
4 Beacon AP DTIM = 1, Beacon = Check with hospital IT if this
& DTIM 100ms requirement is met or not.
5 Service Refer to Mindray Patient Check with hospital IT if this
port Monitoring Network requirement is met or not.
Whitepaper; patient
monitors need some certain
TCP/UDP ports to be opened
3-7
3.5 Network Coverage Assessment with Patient Monitors
To confirm coverage, perform coverage test in the areas where patients often go.
Check whether coverage meets requirements by observing the signal strength (RSSI) showing on Patient
monitor, and by observing whether an offline event occurs.
When necessary, adjust locations of APs or add APs to ensure the overage effect.
Do as follows:
2. Ping the patient monitor on the CMS (input “ping –t –l 32 –w 1500 IP address” in window CLI (Ping
the patient monitor persistently. The packet is 32 bytes and the timeout of reply is 1500ms). After ten
minutes, input “ ctrl + c”(finish the ping), make sure that the mean delay is less than 250ms and the
packet lost rate shall be less than 1%.
3. Hold the patient monitor with a hand and avoid blocking by people. Walk in the expected coverage
areas, for example, all corners of the ward, toilet, smoking area, corridor, and elevator.
4. Offline event time should be less than 10% of patient monitor roaming times; the RSSI value
displayed on the patient monitor is not lower than -65dBm.
5. If the signal strength is lower than -65dBm during walking, stop at the location and observe for 30s. If
the RSSI value is not lower than -65 dB in more than 66 percent of the time, the coverage
requirement is met.
NOTE
If patient monitors do not need to roam between Aps, you can just place patient monitor
where RSSI is lowest, and check the RSSI and ping results.
3-8
3.6 Recommended Devices for WLAN
The following Cisco devices listed in table below are recommended.
Device Part Number
2500 Wireless Controller AIR-CT2504-x-K9
2600 Access Point AIR-CAP2602I-x-K9
3-9
Parameter Recommended Setting Comments
match the WLAN AP channel settings.
Main Menu→Maintenance→User Maintenance→Network Setup→WLAN →Certificate Management
Local / Display the existing EAP certificates in a patient
monitor
USB Drive / Display the existing EAP certificate in the USB drive
Main Menu→Maintenance→Factory Maintenance→Setup→WLAN Setup
Regulatory Domain Worldwide Korea, Turkey, Russia, and Brazil need to be configured
separately. For other countries, just choose worldwide.
You need to restart the monitor for the monitor
settings to take effect.
CCX Features Support This means that it supports CCX 4.0 and fast roaming
PMK Caching Standard Options are: Standard, OPMK.
Standard indicates PMK caching.
OPMK indicates opportunistic key caching.
Trigger -70 When the RSSI is lower than the roam trigger, the radio
will try to roam.
Scan Period 5 When the RSSI is lower than the roam trigger, the
period of the probe request is 5s.
After Security Mode of EAP is selected, corresponding configuration item will be displayed. The following
table lists the configuration items for different EAP methods.
Identity Anonymity Password CA User PAC PAC
Certificate Certificate Certificate password
PEAP-MSCHAP Y O Y Y N N N
V2
PEAP-GTC Y O Y Y N N N
PEAP-TLS Y O Y Y Y N N
TTLS Y O Y Y N N N
TLS Y N Y Y Y N N
FAST Y O Y N N Y Y
LEAP Y N Y N N N N
Note: Y means yes, N means No, O means optional.
3-10
The meaning of each configuration item is shown below:
AUT. Protocol (Phase2 Auth): When PEAP in the EAP Method is selected, the user can configure the
following PEAP inner methods: EAP-MSCHAPV2, EAP-GTC, EAP-TLS.
Identity: user identity, it is the user name in the AD, LDAP or local user management on the RADIUS
server.
Anonymity: This item does not impact the authentication process. The function of this item is to hide
the real name (Identity).
User Certificate: choose the User Certificate from the imported certificates.
PAC Certificate: When the EAP-FAST is selected, choose the PAC certificate from the imported
certificates. If the RADIUS server has support In-band PAC provisioning to provision the client with a
PAC, then there is no need to setup the PAC Certificate and password.
PAC password: When the EAP-FAST is selected, input the PAC password for the PAC Certificate. If the
RADIUS server has support In-band PAC provisioning to provision the client with a PAC, then there is
no need to setup the PAC Certificate and password.
3.8 Troubleshooting
Symptom Possible Cause Recommended Measure
The monitor cannot The nearby AP is not turned on. Ensure that the AP is turned on and belong to the
connect to the AP VLAN where the monitor resides.
and an X is The monitor is not turned on in Walk to the coverage area of the AP and turn on the
displayed on the the coverage area of the AP. monitor. Ensure that the signal strength indicated on
Wi-Fi signal icon on the monitor is larger than –65 dBm.
the monitor. Ensure that the intra-frequency interference meets the
requirement.
The SSID, IP address acquisition Configure the information again by referring to this
mode, and security mode are not manual.
correctly configured on the
monitor.
The monitor fails. Check whether another monitor can get online. If yes,
restart the monitor and ensure that the configurations
of the two monitors are consistent. If the monitor still
cannot get online, return the monitor to Mindray for
repair.
The monitor can The monitor is not admitted on Admit the monitor on the CMS.
connect to the AP the CMS.
but cannot connect The monitor cannot obtain any IP Enable other network equipment to connect to the
to the CMS. address and the IP addresses in CMS and check whether an IP address can be
the IP address pool on the DHCP obtained.
3-11
Symptom Possible Cause Recommended Measure
server are used up. If the problem cannot be solved, contact the IT
department.
A static IP address conflict occurs. Observe whether a prompt indicating IP address
conflict is displayed on the monitor.
If so, make sure all network devices have unique IP
addresses.
The network link fails. Check whether the CMS can be pinged by using PC
or cell-phone.
If the problem cannot be solved, contact the IT
department.
The services required by the Check whether the services required by the monitor
monitor are not enabled on the are enabled on the hospital network and enable
hospital network. related services, such as certain UDP ports and
multicast.
If the problem cannot be solved, contact the IT
department.
A single monitor The monitor moves to a coverage Ensure that the signal strength is larger than –65 dBm
becomes hole. at the position where the monitor is disconnected.
disconnected The monitor is faulty. Check whether the monitor is disconnected easily at
intermittently the same position. If the problem cannot be solved
after the monitor is restarted, return the monitor to
Mindray for repair.
A static IP address conflict occurs. Observe whether a prompt indicating IP address
conflict is displayed on the monitor.
Check whether an IP address is assigned to more than
one device.
Multiple monitors The APs in some areas are Ensure that the APs are turned on and run properly.
become damaged.
disconnected The interference is intense in Check whether the interference is intense by using a
intermittently certain areas. network survey tool and remove obvious interference
sources or adjust WLAN deployment to meet the
requirements of Mindray.
The signal coverage is Check the signal coverage by using network survey
insufficient in some areas. tool. If signal coverage is insufficient in any area, adjust
the position of the AP or add an AP.
All monitors The wired network is configured Check the wired network configuration by using a
become improperly. wired monitor. Ensure that the WLAN bandwidth
disconnected configured on the switch is sufficient with a margin of
intermittently 50%.
There is radio interference. Check whether there is radio interference by
usingnetwork survey tool and remove obvious
interference sources or adjust WLAN deployment to
meet the requirements of Mindray.
3-12
4 Testing and Maintenance
4.1 Introduction
To ensure the patient monitor always functions properly, qualified service personnel should perform regular
inspection, maintenance and test. This chapter provides a checklist of the testing procedures for the patient monitor
with recommended test equipment and frequency. The service personnel should perform the testing and
maintenance procedures as required and use appropriate test equipment.
The testing procedures provided in this chapter are intended to verify that the 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 our Customer Service Department.
CAUTION
All tests should be performed by qualified service personnel only.
Care should be taken when changing the settings in Maintenance and Configuration menus to avoid loss
of data.
Service personnel should possess a working knowledge of the test tools and make sure that test equipment
and cables are applicable.
4-1
4.1.4 Recommended Frequency
Check/Maintenance Item Frequency
Preventative Maintenance Tests
Visual inspection When first installed or reinstalled.
Pressure check
NIBP tests
Leakage test 1. If the user suspects that the measurement is incorrect.
Leakage test 2. Following any repair or replacement of relevant module.
Sidestream and
Performance test 3. For NIBP module, at least once every two years; for CO2 and AG
Microstream CO2 tests
Calibration modules, once a year.
Performance test 4. AG leakage test should be performed before AG measurement.
AG tests
Calibration
Performance Tests
Performance test
ECG tests
Calibration
Resp performance test
SpO2 test
Pressure check
NIBP test
Leakage test
Temp test
Performance test
IBP tests
Pressure calibration
C.O. test 1. If the user suspects that the measurement is incorrect.
Mainstream CO2 test 2. Following any repair or replacement of relevant module.
Leakage test 3. At least once every two years. For CO2, AG and NMT modules, at
Sidestream and
Performance test least once a year.
Microstream CO2 tests
Calibration 4. AG leakage test should be performed before AG measurement.
Leakage test
AG tests Performance test
Calibration
EEG test
BIS test
RM test
Interconnecting function
CCO/SvO2 tests
Output calibration
Performance test
NMT tests
Sensor check
PiCCO test
Nurse call relay performance test If the user suspects that the nurse call or analog output does not
Analog output performance test work well.
4-2
Electrical Safety Tests
Earth impedance
1. Following any repair or replacement of the power module.
Earth leakage test
Electrical safety tests 2. When the patient monitor is dropped.
Patient leakage current
3. At least every two years or as required.
Patient auxiliary current
Other Tests
1. When first installed or reinstalled.
Power on test 2. Following any maintenance or the replacement of any main unit
parts.
Recorder check Following any repair or replacement of the recorder.
1. When first installed.
Network print test
2. Whenever the printer is serviced or replaced.
1. When first installed.
Device integration check
2. Following any repair or replacement of the external device.
1. When first installed.
Function test
2. Whenever a battery is replaced.
Battery check
Once every two months or when the battery run time is reduced
Performance test
significantly.
1. When first installed.
Mounting check
2. At least every two years or as required.
Note: Performance test is not required for the ICG, rSO2, Tympanic Temp and ScvO2 modules, because the first three
modules perform self tests, and the last one needs to be calibrated prior to use.
Carefully inspect the case, display screen, buttons and handle for obvious signs of damage.
Inspect the SMR and parameter modules for obvious signs of damage.
Inspect the power cord, 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.
4-3
4.2.2 NIBP Tests
NIBP Accuracy Test
Tools required:
T-shape connector
Tubing
Squeeze bulb
Monitor Manometer
Tubing
NIBP connector
2. Before inflation, the reading on the manometer should be zero. If not, open the valve of the squeeze bulb to let
the whole airway open to the atmosphere. Close the valve after the reading turns to zero.
3. Select Main Menu → Maintenance → enter the required password → Module → NIBP → NIBP Accuracy
Test.
4. Check the reading of the manometer and the reading of the patient monitor. 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 reading of the manometer with the reading of the patient monitor. The difference should be 3
mmHg. If it is greater than 3 mmHg, contact your service personnel.
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. 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.
4-4
Leakage Test
Tools required:
Tubing
Cylinder
2. Connect the NIBP cuff to the NIBP connector on the patient monitor.
Cylinder
Monitor
Hose
NIBP Cuff
4. Select Main Menu → Maintenance → enter the required password → Module → NIBP → NIBP Leakage
Test. The message NIBP Leakage Test is displayed in the NIBP parameter area.
5. The cuff automatically deflates after 20s, which means NIBP leakage test is completed.
6. If no message is displayed in the NIBP parameter area, it indicates that the system has no leak. If the message
NIBP Pneumatic Leak is displayed, it indicates that the system may have a leak. In this case, verify the connections
and make sure that the NIBP cuff, hose, and connectors are not leaking. Then, perform the test again.
2. Raise the pressure in the rigid vessel to 250 mmHg with the squeeze bulb. Then, wait for 5 seconds until the
measured values become stable.
3. Record the current pressure value and meanwhile count time with a timer. Then, record the pressure value after
counting to 60 seconds.
4. Compare the two values and make sure the difference is not greater than 6 mmHg.
4-5
NIBP Overpressure Protection Circuit Test
Tools required:
T-shape connector
Approprating tubing
Balloon pump
2. Select [Main Menu]→ [Maintenance ]→enter the required password →[Factory Maintenance]→ [NIBP].
3. Set [Patient Category] to [Adult/Ped] in the [Overpressure Protection Circuit Test]. Raise the pump pressure to
320-330 mmHg. After the pressure value is stabilized, select the [Test] button to start a calibration, and the [NIBP]
menu will display [Test successful] ,When raise the pump pressure out of the range of 320-330 mmHg, and select
the [Test] button to, the [NIBP] menu will display [Test Failed].
4. Set [Patient Category] to [Neo] in the [Overpressure Protection Circuit Test], and raise the pressure to 160-165
mmHg. After the pressure value is stabilized, select [Test] to start a calibration. and the [NIBP] menu will display
[Test successful] ,When raise the pump pressure out of the range of 160-165 mmHg, and select the [Test] button,
the [NIBP] menu will display [Test Failed].
2. Wait until CO2 warmup is finished and then completely block the gas inlet of the module or water trap (by using
your finger or other objects). The sidestream and microstream CO2 modules will behave as follows:
Sidestream: Plug the sidestream CO2 module into the module rack of the main unit. Wait one minute until
the module warmup is finished and then completely block the gas inlet of the module (you may use a
pneumatic plug or your finger to manually occlude the port). An alarm message CO2 Airway Occluded will
appear on the screen. Block the gas inlet for another 60 seconds. Select Main Menu → Maintenance →
enter the required password → Module → CO2 → Calibration. If the flow rate is less than 10 ml/min and
the alarm message continues, it indicates that the module does not leak. If the alarm message CO2 Airway
Occluded disappears, or the flow rate is greater than or equal to 10 ml/min, it indicates that the module
leaks.
Microstream: The alarm message CO2 Purging is displayed on the screen after 3 seconds. Block the gas inlet
for another 30 seconds. If alarm message CO2 Airway Occluded is displayed, it indicates that the module
does not leak.
4-6
Accuracy Test
Tools required:
A steel gas cylinder with >40% O2 and balance gas N2 (applicable to sidestream CO2 module with O2 module
equipped)
T-shape connector
Tubing
Flowmeter
2. Wait until the CO2 module warmup is finished. Check the airway for leak and perform a leakage test as well to
make sure that the airway has no leak.
3. Select Main Menu → Maintenance → enter the required password → Module → CO2 → Calibration.
Flowmeter
Tubing
Relief valve
Monitor
T-shape connector
Gas cylinder
5. Open the relief valve, and adjust it until the flowmeter has a stable reading between
10 ml/min and 50 ml/min.
6. Verify that the real-time CO2 value is within 6±0.2% in the Calibrate CO2 menu (for microstream CO2, the value is
45±2 mmHg).
7. Replace the cylinder to the steel gas cylinder with >40% O2 and balance gas N2(applicable to sidestream CO2
module with O2 module equipped) and verify that the real-time O2 value error is within ±2% (when O2≤80%) or
±3% (80%≤O2≤100%).
4-7
Calibration
Tools required:
A steel gas cylinder with >40% O2 and balance gas N2 (applicable to sidestream CO2 module with O2 module
equipped)
T-shape connector
Tubing
Flowmeter
1. Make sure that the sidestream or microstream CO2 module has been warmed up or started up.
2. Check the airway for leaks and perform a leakage test as well to make sure that the airway has no leakage.
3. Select Main Menu → Maintenance → enter the required password → Module → CO2.
5. After the zero calibration is finished successfully, connect the equipment as follows:
Flowmeter
Tubing
Relief valve
Monitor
T-shape connector
Gas cylinder
6. Open the relief valve, and adjust it until the flowmeter has a stable reading between
10 ml/min and 50 ml/min.
7. In the Calibrate CO2 menu, enter 6% (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.
9. Replace the cylinder to the steel gas cylinder with >40% O2 and balance gas N2(applicable to sidestream CO2
module with O2 module equipped) and calibrate O2.
If the calibration is finished successfully, the message Calibration Completed! is displayed in the Calibrate CO2 menu. If
the calibration failed, the message Calibration Failed! is displayed. In this case, check whether the operations are
correct and perform another calibration. If the calibration fails several times, return the module to Mindray for repair.
4-8
4.2.4 AG Tests
Leakage Test
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 60 seconds. Select Main Menu → Maintenance → enter the required password
→ Module → AG → Calibration. Check that the flow rate is less than 10 ml/min. If the alarm message
continues, it indicates that the module does not leak.
If the alarm message disappears, or the flow rate is greater than or equal to 10 ml/min, it indicates that the module
leaks.
Accuracy Test
Tools required:
Gas cylinder with a certain standard gas (such as 6±0.05% CO2, Bal N2) or standard gas mixture. Gas concentration
should meet the following requirements: AA > 1.5%, CO2 > 1.5%, N2O > 40%, O2 > 40%, of which AA represents
an anesthetic agent. Precision requirement: a/c ≤ 0.01 (a is the gas absolute concentration accuracy; c is the gas
concentration)
T-shape connector
Tubing
Flowmeter
2. Wait at least 10 min and then perform a leakage test to make sure that the airway has no leakage.
Flowmeter
Tubing
Relief valve
Monitor
T-shape connector
Gas cylinder
4. Open the relief valve, and adjust it until the flowmeter has a stable reading between 10 ml/min and 50 ml/min.
4-9
5. Verify that the concentration of each composition meets the specification stated in the Operator's Manual.
Calibration
Tools required:
Gas cylinder with a certain standard gas (such as 6±0.05% CO2, Bal N2) or standard gas mixture. Gas
concentration should meet the following requirements: AA [1.5%,7.0%], set step length: 0.1, CO2 [1.5%,7.0%], set
step length: 0.1, N2O [40%,100%], set step length: 5, O2 [40%,100%], set step length: 5, of which AA represents an
anesthetic agent. Precision requirement: a/c ≤ 0.01 (a is the gas absolute concentration accuracy; c is the gas
concentration)
T-shape connector
Tubing
Flowmeter
1. Select Main Menu → Maintenance → enter the required password → Module → 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 Flow Rate and Set Flow Rate 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.
Perform a leakage test to make sure that the airway has no leakage.
4. Open the relief valve and vent a certain standard gas or gas mixture. Adjust the relief valve until the flowmeter
has a stable reading between 10 ml/min and 50 ml/min.
Flowmeter
Tubing
Relief valve
Monitor
T shape connector
Gas cylinder
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.
4-10
6. Enter the vented gas concentration. If you use only one gas for calibration, set other gases' concentration to 0. If
the calibration is performed for all gases, the gas with an entered calibration value of 0 is not
calibrated.
7. Select Calibrate 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. In this case, perform another calibration. If the calibration fails
several times, return the module to Mindray for repair.
CAUTION
Calibrate the O2 module, if it has been transported for long distance.
1. Connect the patient monitor to the AC mains. The AC mains LED and battery LED light up.
2. Press the power on/off switch to switch on the patient monitor. The system sounds a beep indicating the self test
on alarm sounds is passed. The alarm lamps light red, yellow and cyan respectively, and then go off, indicating
the self test on alarm is passed.
3. The patient monitor enters the main screen and start-up is finished.
Tools required:
1. Connect the patient simulator with the ECG module using an ECG cable.
2. Set the patient simulator as follows: ECG sinus rhythm, HR = 60 bpm with the amplitude as 1 mV.
3. Verify that the ECG waves are displayed correctly without noise and the displayed HR value is within 60±1 bpm.
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.
4-11
ECG Verification
Tools required:
Vernier caliper
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 necessary, you can print out the square wave and wave scale through the recorder and then measure the difference.
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 500 Ω; delta impedance
as 1 Ω, respiration rate as 20 rpm.
3. Verify that the Resp wave is displayed without any distortion and the displayed Resp value is within 20±1 rpm.
None.
1. Connect SpO2 sensor to the SpO2 connector of the monitor. Set Patient Category to Adult and PR Source to SpO2
on the monitor.
3. Check the Pleth wave and PR reading on the screen and make sure that the displayed SpO2 is within 95%
and100%.
4. Remove the SpO2 sensor from your finger and make sure that an alarm of SpO2 Sensor Off is triggered.
4-12
NOTE
A simulator cannot be used to assess the accuracy of a pulse oximeter monitor or a SpO2
sensor. Instead, it can only verify that whether the monitor is functional. The accuracy of a
pulse oximeter monitor or a SpO2 sensor needs to be verified by clinical data.
1. Connect the two pins of any Temp connector of a module to the two ends of the resistance box using two wires.
3. Verify each Temp channel of the monitor and make sure that the displayed value is within 37±0.1ºC.
Tools required:
Dedicated IBP adapter cable (300B, P/N 00-002199-00) (use P/N 00-002198-00, if the simulator is MPS450)
6. If the value is outside of these tolerances, calibrate the IBP module. If the IBP module was calibrated with a
dedicated reusable IBP sensor, check the calibration together with this IBP sensor.
7. Make the patient simulator outputs 120/80 mmHg ART signals and 120/0 mmHg LV signals respectively to each
IBP channel and check that the IBP wave is displayed correctly.
Pressure Calibration
Method 1:
Tools required:
Dedicated IBP adapter cable (300B, P/N 00-002199-00) (use P/N 00-002198-00, if the simulator is MPS450)
4-13
1. Connect the patient simulator to the monitor's IBP connector.
2. Set the patient simulator to 0 pressure for the desired IBP channel.
5. Select Main Menu → Maintenance → enter the required password → Module → IBP. 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
1. Connect the 3-way stopcock, the sphygmomanometer and the squeeze bulb through a T-shape connector, as
shown below.
2. Zero the transducer, and then open the stopcock to the sphygmomanometer.
Pressure transducer
3-way stopcock
IBP
T-shape connector
module
Sphygmomanometer
3. Select Main Menu→ Maintenance → enter the required password → Module → IBP. In the displayed
interface, set the target calibration value of the target channel. Value range: 80 to 300 mmHg.
4. Inflate using the squeeze bulb until the reading of sphygmomanometer approximates the preset calibration
value.
5. Adjust the calibration value in the Maintain IBP menu until it is equal to the reading of sphygmomanometer
6. Select the Calibrate button next to the desired IBP channel to start a calibration.
If the calibration is completed successfully, the message Calibration Completed! will be displayed. Otherwise, a
corresponding message will be displayed.
4-14
4.4.7 C.O. Test
Tools required:
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. Switch off Auto TI and adjust TI (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 5 L/min on the C.O. simulator. Select Start in the C.O.
measurement window to start C.O. measurements, and press the run key on the simulator after 3-10 seconds.
NOTE
Make sure that the barometric pressure set in Main Menu → Maintenance → enter the
required password → Other accords with the local barometric pressure before performing
mainstream CO2 tests.
Tools required:
T-shape connector
Tubing
Flowmeter
1. Plug the module into the module rack and connect the sensor.
2. Wait until CO2 warmup is finished. Select the CO2 waveform or parameter to enter the CO2 Setup menu. Then,
select Start Zero Cal. to start a zero calibration. If the zero calibration fails, the prompt message CO2 Zero Failed is
displayed. Otherwise, the baseline of waveform recovers to zero.
4. Blow to the CO2 sensor to generate a CO2 waveform and then place the sensor in the air. Check if the alarm
message *** Apnea is displayed on the screen.
4-15
Relief valve Flowmeter
T-shape
connector
Monitor
T-shape connector
Relief valve
6. Turn on the relief valves of N2 gas cylinder and CO2 cylinder respectively to ensure that only one gas cylinder is
connected to the T-shape connector at a time.
7. Adjust the relief valves respectively to ensure a stable flow by maintaining the reading on the flowmeter at a
value between 2 and 5 L/min.
8. Switch between the two cylinders to connect Mainstream CO2 sensor at intervals of
6 -10s and check if the displayed CO2 value is 45±2 mmHg.
4.4.10 AG Tests
See section 4.2.4AG Tests.
4-16
4.4.11 EEG Test
You can choose either of the following methods to perform the test:
Method 1:
Tools required:
Set the ECG simulator to output Sine wave and frequency to between 0.5 and 30Hz. The range is 2mV. The GND pin of
EEG module connects to RL of ECG simulator. The A+ pin of EEG module connects to LA of ECG simulator. The other
pins of EEG lead wires connect to any ECG lead as you wish.
2. Open the EEG setting menu on monitor, Set the Scale of EEG to be 2000uV. Then you can find a Sine wave on
screen of Patient Monitor.
Method 2:
Tools required:
None.
Connect all the pins of EEG lead wire together, for example, you can connect them to some metal materials. Then
check the EEG module resistance test, if all the leads are green then pass.
Method 3:
Tools required:
Resistance box
Multimeter
1. Connect the EEG module/cable to the EEG simulator and the monitor.
3. Adjust the resistance box to 1 kΩ, verify the resistance value displayed on the monitor is 1kΩ.
4. Test the lead type of the monitor to B+, C+ and D+ respectively instead of lead A+.
5. Set Montage Type: Monopolar Mode , then repeat the step 3~4.
4-17
BIPOLAR
RA = 10 K A+
RA = 10 K A-
RA = 10 K PGND
MONOPOLAR
RA = 10 K A
RA = 10 K NE
RA = 10 K PGND
Method 1:
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 and 100.
Method 2:
Tools required:
1. Connect the BIS sensor with the BIS simulator. Select BIS area parameter or waveform to access BIS Setup. Then,
select Sensor Check to perform a cyclic impedance check.
2. After the cyclic impedance check is finished, check that the result for each electrode is passed.
Method 3:
Tools:
1. Insert the BIS module to the monitor, connect the BIS module/cable to the Covidien Signal simulator, signal
generator.
2. Adjust the signal generator to produce a 90Hz, 35.4mV(RMS) sine signal to the Convidien Signal simulator.
4-18
3. Set the time length of the review window to the shortest.
4. Verify the EMG value range from 65 to 75, and SQI value should be 100 displayed on Graphic Trends.
4.4.13 RM Test
Method 1:
Tools required:
T-shape connector
Tubing
Squeeze bulb
3. Use the squeeze bulb to exert a test pressure of 60cmH2O, and check whether the RM airway pressure precision
meets the requirement of 58.2~61.8cmH2O.
Monitor Reference
manometer
RM sensor
RM connector
Method 2:
Tools required:
Tubing
1. Connect the module, RM sensor, air pump and pressure gauge according to picture below.
4-19
3. Use air pump to inflate to -20, 0, 10, 60, 120cmH2O pressure, verify RM module measured airway pressure
accuracy is ±3% of reading.
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. Start the CCO and SvO2 tests in Demo mode.
3. Verify that the CCO/SvO2 numerics displayed on the patient monitor and Vigilance monitor are consistent.
Output Performance
Tools required:
Multimeter
1. Connect the signal output end of the connecting cables of the CCO/SvO2 module to the oscilloscope.
2. Select CCO Setup → Signal Output Setup and then select Simulated High Value from the pop-up menu. Check
that the amplitude of electrical level at the signal output port of ECG, MAP, CVP and SpO2 are 5±0.015 V, 5±0.25 V,
5±0.25 V and 10±0.5 V respectively.
4-20
4.4.15 PiCCO Test
Performance Test
Tools required:
1. Connect the patient simulator, the PiCCO IBP test cable and the PiCCO module.
2. Let the patient simulator outputs 0 mmHg respectively to the pArt channel and the pCVP channel.
3. Select the pArt parameter interface to access the pArt Setup menu, and then select Zero.
4. Select the pCVP parameter interface to access the pCVP Setup menu, and then select Zero.
5. Let the patient simulator output static pressure 200 mmHg to pArt channel and 20 mmHg to pCVP channel.
6. The pArt value displayed on the monitor should be within 200±4 mmHg, and pCVP value within 20±1 mmHg.
7. If the pArt error is beyond ±4 mmHg or pCVP error beyond ±1 mmHg, calibrate the PiCCO module. If the module
was calibrated with a dedicated reusable IBP sensor, check the calibration together with this IBP sensor.
8. Let the patient simulator output ART signal to the pArt channel and CVP signal to the pCVP channel, check
whether the IBP waveform is correctly displayed.
Pressure Calibration
Method 1:
Tools required:
1. Connect the patient simulator, the PiCCO IBP test cable and the PiCCO module.
2. Let the patient simulator outputs 0 mmHg respectively to the pArt channel and the pCVP channel.
3. Select the pArt parameter interface to access the pArt Setup menu, and then select Zero.
4. Select the pCVP parameter interface to access the pCVP Setup menu, and then select Zero.
6. Select Main Menu → Maintenance → enter the required password → Module. In the IBP menu, set the
calibration pressure to 200 mmHg.
7. Select the Calibrate button next to the desired IBP channel to start a calibration.
The message Calibration Completed! is displayed after a successful calibration. Otherwise, a corresponding message
will be displayed.
Method 2:
Tools required:
Standard sphygmomanometer
4-21
Squeeze bulb
Tubing
T-shape connector
1. Connect the 3-way stopcock, the sphygmomanometer and the squeeze bulb through a T-shape connector, as
shown below.
2. Turn on the 3-way stopcock to the air to zero the transducer, and then open the stopcock to the
sphygmomanometer.
Pressure transducer
3-way stopcock
IBP
T-shape connector
module
Sphygmomanometer
3. Select Main Menu → Maintenance → enter the required password → Module. In the IBP menu, set the target
calibration value of the target channel.
4. Inflate using the squeeze bulb until the reading of sphygmomanometer approximates the preset calibration
value.
5. Adjust the calibration value in the Maintain IBP menu until it is equal to the reading of sphygmomanometer
6. Select the Calibrate button next to the desired IBP channel to start a calibration.
The message Calibration Completed! is displayed after a successful calibration. Otherwise, a corresponding message
will be displayed.
C.O. Test
Method 1:
Tools required:
1. Connect the patient simulator and the C.O. module using a C.O. trunk cable and a C.O. adapter box.
2. Set the blood temperature (BT) to 37ºC on the patient simulator and check the temperature value is 37±0.1ºC.
4-22
3. Select CCO parameter interface to access the C.O. Measure interface. Then, select Setup to check whether the
value of Catheter Type is PV2015L20.
4. Turn the injectate temperature (TI) knob on the C.O. adapter box to set the TI to 20±1ºC for the patient simulator
and C.O. to 5 L/min.
5. In the C.O. Measurement window, select Start to start C.O. measurement. As soon as the prompt Inject XXml is
displayed, adjust TI to 4±1ºC, and then quickly back to 20±1ºC. Simultaneously press the button on the simulator
that corresponds to 5 L/min. The whole procedure shall be finished in 10 seconds.
Method 2:
Tools required:
1. Connect the patient simulator and the C.O. module using a C.O. trunk cable and a C.O. adapter box.
2. Set the blood temperature (BT) to 37ºC on the patient simulator and check the temperature value is 37±0.1ºC.
3. Select CCO parameter interface to access the C.O. Measure interface. Then, select Setup to check whether the
value of Catheter Type is PV2015L20.
4. Turn the injectate temperature (TI) knob on the C.O. adapter box to check whether the value of the TI is from 0 to
30ºC.
Method 1:
Tools required:
Resistance box
Multimeter
1. Set the resistance value to 1kOhm. Connect the stimulation electrodes to the two wiring terminals.
2. Set the multimeter to operate in DC mode. Connect the multimeter sensors to the NMT stimulation electrodes,
making sure that the sensor and electrode connected have the same polarity.
3. Insert the NMT module into the module rack of the monitor. Select the NMT parameter area of the monitor to
access the NMT Setup menu. Set the Stimulation Current to Supra(60mA). Set the Pulse Width to 300μs. Perform
a PTC measurement.
4. Check the voltage change detected by the multimeter and verify normal output of NMT stimulation.
Method 2:
Tools required:
4-23
Resistance box (0~9999.9 Ω)
1. Set resistance box to 1kOhm, connect stimulation electrodes to the resistance box.
2. Insert the NMT module to monitor. Set [Stimulation current] to [Supra (35mA)], [Pulse width] to 200μs. Select [ST
Mode] in NMT setup menu to start a ST measure.
3. Measure the voltage wave of the resistance box by oscilloscope, verify the pulse width is range from 180 to 220us,
and calculate the Stimulation Current according stimulation voltage should be range from 33 to 37mA.
Sensor Check
Tools required:
None.
2. Select Main Menu → Maintenance → enter the required password → Module → NMT.
If sensor check completes successfully, the message Test passed. The function of NMT sensor is OK is displayed,
indicating a functional sensor. If the check fails, check whether the sensor is placed correctly as instructed, and
perform the sensor check again.
NOTE
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 >> → enter the required password → Alarm to
access the Nurse Call setup menu.
3. In Nurse Call menu, select all options of Alarm Priority and Alarm Type. and set Contact Type to Normally Open.
4. In Nurse Call 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.
4-24
5. In Nurse Call 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.
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 MPM module of the patient monitor.
2. Verify that the waves displayed on the oscilloscope are identical with those displayed on the monitor.
WARNING
Electrical safety tests are a proven means of detecting abnormalities that, if undetected, could
prove dangerous to either the patient or the operator.
All tests can be performed using commercially available safety analyzer test equipment.
Maintenance personnel shall ensure the adaptability, functional completeness and safety of
these pieces of test equipment, and be familiar with their usage.
Electrical safety tests shall comply with the following standards: IEC 60601-1 and ANSI/AAMI
ES60601-1.
In case of other stipulations in local laws and regulations, implement electrical safety tests by
following relevant stipulations.
All devices driven by AC power and connected to medical instruments in patient zones must
comply with the IEC 60601-1 standard. And electrical safety tests on these devices must be
implemented in accordance with the test interval of the patient monitor.
Use certified safety analyzer (for example, UL, CSA or AMAI) as instructed to perform relevant
tests.
NOTE
Electrical safety check shall be performed after repair or routine maintenance. Ensure that all cover boards,
panels and screws are correctly installed before implementing electrical safety tests.
Electrical safety tests are used to timely detect potential electrical safety risks that might cause damage to
patients, operators or maintenance personnel. Electrical safety tests must be carried out under normal
environmental conditions (that is, normal temperature, humidity and barometric pressure).
4-25
See Appendix A Electrical Safety Inspection for electrical safety tests.
None.
1. Print ECG waveforms. The recorder should print correctly and the printout should be clear.
2. Set the recorder to some problems such as out of paper, etc. the patient monitor should give corresponding
prompt messages. After the problem is removed, the recorder should be able to work correctly.
3. Switch automatic alarm recording for each parameter ON and then set each parameter's limit outside set alarm
limits. Corresponding alarm recordings should be triggered when parameter alarms occur.
BeneVisi Network
on printer
Switch
2 Select Main Menu → Maintenance → enter the required password →Network Setup and 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 Select Main Menu → Maintenance → enter the required password → Print and set the IP address of the
printer to the actual IP address, and set the paper size to the actual size.
5 Click Print Test Page to check whether the output of the printer's test page is normal. If not, recheck the
connection and configuration of the printer.
4-26
4.10 Device Integration Check
Refer to BeneLink Module Operator’s Manual (P/N: 046-009023-00).
None.
Function Test
1. Verify that the patient monitor works properly when running on AC power.
2. Remove the AC power cord and verify that the patient monitor still works properly.
Performance Test
Perform the test procedure in the Battery section in the Operator's Manual and verify the operating time of the
battery meets the product specification.
None.
Check that the screws fastening the bracket and guide rail are not loose.
Check that the five installation screws on the bottom side of the N12 monitor are not loose.(six installation
screws for N15 and N17)
Check that the four installation screws on the transfer metal and monitor bottom side are not loose.
Check that it can be installed in place and locked when N12 monitor use fast lock installed way
Check that it can be installed in place and locked when the monitor use on the cart installed way
Check that the modules can be normally and securely inserted into the module rack.
Check that the trim strip is properly installed after the display is disassembled and repaired.
4-27
Check that the monitor handle is not loose.
Check that the VHM bracket can place the monitor at any height as required.
4-28
4.13.3 Production Test
This tab page lists the basic functions of major hardware interfaces of the monitor. Production test can be classified
into auto test and single test. If auto test is selected, the system will automatically complete all the tests in sequence;
for single test, users can select a specific test as required. The test interface is shown in the following figure.
4.13.4 Setup
This tab page supports the settings relevant to ECG alarms and other configurations.
Neonate ST analysis switch: Switch it on to enable the neonate ST analysis function; switch it off to disable
relevant functions of neonate ST analysis.
HR/PR alarm off switch: Switch it on to set the HR/PR alarm switch; switch it off to disable the setting of HR/PR
alarm switch.
HR alarm delay switch: Switch it on to enable the HR alarm affected by the setting of alarm delay; switch it off to
prevent the HR alarm from being affected by the setting of alarm delay.
Update ID Module: Provide interface for burning device integration ID. Users should confirm the BeneLink port
and device ID before burning.
4-29
4.13.5 Debug
This tab page provides settings related to the debug mode, which is only applicable to testing.
4.13.7 ClinicalData
This tab page provides settings related to clinical data collection.
4-30
Clinical Data Location: Supports the settings of data storage location. (None indicates not stored; Local indicates
saving locally; and Udisk indicates saving in a USB disk.)
NOTE
The recorder is disabled if Recorder is switched off in the Factory Maintenance menu.
Test Test
Test items
records results(Pass/Fail/NA)
Visual Inspection
The case, display screen, buttons, handle, SMR, modules, power
cord, wall-mount bracket and accessories have no obvious signs
of damage.
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The external connecting cables are not frayed and the connector
pins are not loose and bent.
The external connectors are not loose or their pins are not bent.
The safety labels and data plate are clearly legible.
Power on test
The power-on test is passed. The power indicator and alarm
system work correctly and the monitor start up properly.
Performance test
ECG performance test
ECG waves are displayed correctly without noise and the HR value
is within 60±1 bpm.
ECG Lead Off alarm behaves correctly.
Paced signals are detected and pace pulse marks are displayed
when Paced is set to Yes.
The difference between the amplitude of the ECG calibration
square wave and that of the wave scale is not greater than 5%.
Resp test
The Resp wave is not distorted and the Resp value is within 20±1
rpm.
SpO2 test
Measure SpO2 on a healthy person's finger and a Pleth wave and
PR value are displayed. The displayed SpO2 value is within
95%-100%.
SpO2 Sensor Off alarm behaves correctly.
NIBP test
The difference is within ±3 mm when 0, 50 or 200 mmHg is set for
NIBP accuracy test.
There is no leakage with NIBP, or the manual leakage test result
does not exceed 6mmHg/min.
Temp test
The value displayed for each Temp channel of the monitor is
within 37±0.1ºC.
IBP test
The static pressure value displayed for each IBP channel is within
200±2 mmHg.
The ART and LV waves for each IBP channel are displayed
correctly.
C.O. test
The TB value displayed on the monitor is within 37±0.1ºC.
The displayed C.O. value is within 5±0.25 L/min.
Mainstream CO2 test
The mainstream CO2 is zeroed successfully and the waveform
baseline recovers to zero.
CO2 Apnea alarm behaves correctly.
The displayed CO2 value is 45±2 mmHg.
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Sidestream CO2 test
Block the gas inlet of the module or watertrap. The sidestream
CO2 flowrate is slower than 10ml/min and an alarm of CO2 CO2
Airway Occluded is given. It indicates that there is no leakage.
The displayed CO2 value is 6±0.05%.
The displayed O2 value is within ±2% (when O2≤80%) or ±3%
(80%≤O2≤100%)
Microstream CO2 test
Block the gas inlet of the module or watertrap for about 30
seconds. An alarm of CO2 Airway Occluded is given. It
indicates that there is no leakage.
The displayed CO2 value is 45±2 mmHg.
AG test
When AG flowrate is slower than 10ml/min, an alarm of AG Airway
Occluded is given. It indicates that there is no leakage.
The measurement accuracy of CO2, N2O, O2 and AA (AA represents
an anesthetic agent) meets the product specifications in the
Operator's Manual.
EEG test (you can select either method to perform the test)
Method 1: The EEG wave is displayed on the monitor.
Method 2: All the leads are green then pass in the EEG module
resistance test.
Method 3: The resistance values displayed on the monitor are 1kΩ
BIS test (you can select either method to perform the test)
Method 1: The BIS value measured on healthy, wide-awake adult
is within 80-100.
Method 2: The result of impedance check for each electrode is
passed.
Method 3: The EMG value range is from 65 to 75, and SQI value is
100 displayed on [Graphic Trends]
RM test(you can select either method to perform the test)
Method 1: The RM airway pressure is 58.2~61.8 cmH2O.
Method 2: The difference is within ±3% of reading when -20, 0,
10, 60, 120cmH2O is set for RM airway pressure accuracy test.
CCO/SvO2 test
The CCO/SvO2 numerics displayed on the patient monitor and
Vigilance monitor are consistent.
The waves (at the ECG signal output port) displayed on the
oscilloscope are consistent with the ECG calibration waves
displayed on the monitor screen.
The amplitude of electrical level at the signal output port of
MAP, CVP and SpO2 are 5±0.25 V, 5±0.25 V and 10±0.5 V
respectively.
PiCCO test(you can select either method to perform the test)
The pArt value displayed on the monitor is within 200±4 mmHg,
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and the pCVP value is within 20±1 mmHg.
The waveforms of pArt and pCVP are displayed correctly.
Method 1: The BT value is 37±0.1ºC.
The value of CatheterType is PV2015L20
The C.O. value is displayed on the monitor
Method 2: The BT value is 37±0.1ºC.
The value of CatheterType is PV2015L20
The TI value is from 0 to 30ºC
NMT test(you can select either method to perform the test)
Method 1: The voltage change is detected by the multimeter and
the output of NMT stimulation is normal
Method 2: The pulse width is range from 180 to 220us, and the
calculated Stimulation Current is range from 33 to 37mA
The sensor check is pass.
Nurse call relay performance test
The relay contacts are close when an alarm occurs.
Analog output performance test
The waves displayed on the oscilloscope are identical with those
displayed on the monitor.
Electrical safety test
The Power Plug and cord check is passed.
The Visual Inspection of Device Enclosure and Accessories is
passed.
The Contextual Inspection of Device Enclosure and Accessories is
passed.
the Main unit label and Integrated warning labels are present and
legible
The Protective Earth Resistance test is passed
The Earth Leakage Test is passed
The Patient Leakage Current test is passed
The Mains on Applied Part Leakage test is passed
The Patient Auxiliary Current test is passed
Recorder check
The recorder can print ECG waves correctly and the printout is
clear.
Set the recorder to some problems such as out of paper, etc. the
patient monitor should give corresponding prompt messages.
After the problem is removed, the recorder should be able to
work correctly.
Automatic alarm recording for each parameter functions correctly
when parameter alarms occur.
Network print test
The output of the printer's test page is normal.
Device integration check
Devices Integrated window can display the type of the external
4-34
device, ventilation mode, and corresponding parameters
normally.
Battery check
The monitor can operates correctly from battery power when an
AC power failure accidentally occurs.
The operating time of the battery meets the product
specification.
Mounting Check
The screws fastening the bracket and guide rail are not loose
The five installation screws on the bottom side of the N12
monitor are not loose.(six installation screws for N15 and N17)
The four installation screws on the transfer metal and monitor
bottom side are not loose
It can be installed in place and locked when N12 monitor use fast
lock installed way
The modules can be normally and securely inserted into the
module rack
The trim strip is properly installed after the display is
disassembled and repaired
The VHM bracket can place the monitor at any height as required
Conclusion:
Qualified or not: (Yes No)
4-35
FOR YOUR NOTES
4-36
5 Troubleshooting
5.1 Introduction
This chapter lists the problems that may occur during use of the monitor and recommended measures.
Refer to the table in this chapter to check the monitor, and confirm and fix these problems. For more
information about the troubleshooting, please contact the after-sales service department of Mindray.
In addition, check the appearance for damages before powering on. Particularly, when the touch screen of
the screen assembly is damaged, stop using the monitor immediately.
5-1
5.4 Software Version Check
Some troubleshooting tasks may involve software version compatibility. For information about the
configuration and software version of your patient monitor, contact Mindray After-sales Service. To check
the software version, do as follows:
1. Select Main Menu → System >> → Version Information >>. In the displayed menu, you can
check the version information of the system software.
2. Select Main Menu → System >> → Maintenance >> → enter the user's maintenance
password → Version Information >>. In the displayed menu, you can check the version
information of the system software and modules.
Power module
Replace the power module.
defective
5-2
Failure Symptom Possible Cause Countermeasure
protection as the module, external module rack, mouse,
keyboard, USB disk, and scanning gun, first
disconnect these devices from the main unit. If
the monitor can be started after the
disconnection, an external device may fail,
leading to power supply protection.
If the main unit is not connected to other
devices, check whether there is any short circuit
fault in the internal module rack COM board or
main control board and it leads to protection of
the power output.
Main control board Upgrade the software of the main control board.
software abnormal
The touch screen Cable defective or Verify the cable connecting the touch screen to
does not respond improperly connected the main control board is properly connected.
Verify the connecting cable connectors and
corresponding sockets are not damaged.
Main control board Upgrade the software of the main control board.
software abnormal
Touch controller’s Touch the screen stably for 20 seconds, if the touch
firmware is running screen still does not work, please restart the monitor.
wrong. If the touch screen could not work yet, replace the
front case assembly
5-3
5.6.3 Module Rack Failures
Failure Description Possible Cause Troubleshooting
SMR
SMR cannot identify abnormal Check whether the contact screw output
parameter modules voltage of the external module rack is 12 V. If
it is abnormal, the communication module
on the SMR fails.
The parameter module Defective parameter Replace the malfunctioning parameter module
5-4
does not respond module with a known good module. If the patient
monitor identifies the replacement module and
can start measurement, it indicates that the
original module is faulty.
Version inconsistency
between the module
Upgrade the module or internal module rack
communication board
COM board software.
and the internal module
rack COM board
Power supply to the The internal module rack COM board or main
internal module rack is control board may fail, and 12 V cannot be
not correct output.
5-5
Failure Description Possible Cause Troubleshooting
Main control board
Replace the main control board.
failure
5-6
Failure Description Possible Cause Troubleshooting
Main control board
Network interface failure Replace the main control board.
failure
5-7
5.6.8 Network Related Problems
Failure Description Possible Cause Troubleshooting
Verify the network cables and connectors are
intact, the network interface connection is
No connection to the LAN
reliable, and the hub or switch setting is
correct.
MPAN failure Antenna not installed Verify the antenna for the MPAN module is
5-8
Failure Description Possible Cause Troubleshooting
properly installed properly.
5-9
5.6.10 Device Integration Failures
Failure Description Possible Cause Troubleshooting
Replace the ID adapter.
The ID adapter is not compatible
Upgrade the ID of the ID adapter in
with the external device
"Factory Maintenance" menu.
The "Devices
The serial port adapter cable not
Integrated" window
compatible with the external Replace the serial port adapter cable.
displays nothing after
device
connection
Wrong software version or
Verify the protocol version and software
wrong protocol version of the
version are supported by the ID adapter.
external device
5-10
6 Upgrade
6.1 Overview
This monitor supports upgrade of the monitoring parameter function modules, upgrade of the functional
assemblies, and network upgrade of software.
NOTE
For function upgrade involving disassembly of the monitor, eliminate static electricity before
the disassembly. When removing some parts with the electrostatic sensitive mark, wear
protective devices such as electrostatic ring or anti-electrostatic gloves, lest the parts would be
damaged.
Properly connect and route the cables and wires when reassembling the equipment to avoid
pinched hoses and electrical short circuits.
Use specified screws to reassemble 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.
Before removing assemblies, make sure that all the connection lines have been unplugged.
During removal, note to avoid breaking the connection line by pulling or damaging the
connector.
Place the removed screws and other parts separately by category so that they can be used in
the re-installation. Do not drop, contaminate or lose them.
6-1
6.2 Upgrade of Parameter Function Modules
You can upgrade the following parameter modules:
Monitoring Parameter
PN Name and Specification Remarks
Module
MPM module 115-038696-00 MPM-1 Module (MR Spo2/3/5 lead/IBP)
115-038697-00 MPM-3 Module (NC Spo2/3/5 lead/IBP)
MPM-7 Module (MR Spo2/3/5lead/No
115-044666-00
IBP)
MPM-9 Module (NC Spo2/3/5lead/No
115-044667-00
IBP)
115-038698-00 MPM-13 (MR SpO2/12lead/IBP/Analog)
115-038699-00 MPM-14 (NC SpO2/12lead/IBP/Analog)
115-038700-00 MPM-13 (MR SpO2/12lead/IBP/Analog)
115-038701-00 MPM-14 (NC SpO2/12lead/IBP/Analog)
IBP module 6800-30-50850 IBP Module (Package/no accessory)
C.O. module 115-015238-00 CO Module kit (M03B V2.0) No accessory
CO2 module 115-013200-00 CAPNOSTAT CO2 (Package/no accessory)
115-013201-00 ORIDION CO2 (Package/no accessory)
CO2+O2 Module (package/ Adu
115-034095-00
accessory)
115-037385-00 One-slot CO2_O2 module
AG module 115-034108-00 AG Module (package/no accessory)
115-034109-00 AG Module (O2/package/no accessory)
115-034110-00 AG Module (BIS/package/no accessory)
AG Module (O2/BIS/package/no
115-034111-00
accessory)
ICG module 115-034123-00 ICG Module (package/ no accessory)
BIS module 115-013194-00 BIS Module (Package/no accessory)
RM module 115-034114-00 RM Module (package/no accessory)
SPO2 module 115-015015-00 SPO2 Module (MS-2013,No accessory)
SPO2 Module NC (package/ no
115-034088-00
accessory)
115-015016-00 SPO2 Module (9008 V2.0, No accessory)
CCO/SvO2 module CCO/SvO2 Module (Package/no
115-013196-00
accessory)
PiCCO module 115-013196-00 PiCCO Module (Package/no accessory)
ScvO2 module 115-013199-00 SCVO2 Module (Package/no accessory)
EEG module EEG Module (Package/without
115-018353-00
accessory)
NMT module 115-020916-00 NMT Module (Package/no accessory)
Benelink module 115-038771-00 Benelink Module International (Package)
rSO2 module 115-037264-00 rSO2module
6-2
Monitoring Parameter
PN Name and Specification Remarks
Module
TEMP module 115-039492-00 Temp module (package/no accessory)
Infrared ear Temp module Infrared ear Temp (no
115-044684-00
accessory/package)
You can insert and remove all the parameter modules during patient monitoring. Refer to the BeneVision
N Series Patient Monitor Operator's Manual (P/N: 046-009995-00) for the use of parameter modules.
You can upgrade the following functional assemblies for this monitor: the satellite module rack (SMR),
wireless network functional assembly, MPAN, recorder, independent display assembly, iView system
functional assembly, etc.
Functional Assembly PN Name and Specification Remarks
SMR material package (2m/without
115-037384-00
handle and hook)
SMR material package (2m/with handle
SMR 115-033887-00
and hook)
SMR material package (10m/with handle
115-033888-00
and hook)
Recorder 115-044523-00 Recorder upgrade package
Wifi 115-044521-00 2.4G/5G Wifi upgrade package
MPAN 115-044522-00 MPAN upgrade package
iView upgrade package (Without
115-044553-00
iView MainBoard)
115-044578-00 iView upgrade package (MainBoard)
115-044554-00 ID upgrade package (Without MainBoard)
Independent Display
115-044579-00 ID upgrade package (MainBoard)
N12 Upgrade package
115-044508-00 Upgrade package (DVI&TDS&BNC)
(DVI&TDS&BNC)
This monitor is configured with wireless network functions and can be connected to network through
wireless AP. To upgrade wireless functions, ask authorized personnel of our company to connect and set
up the wireless network, and then carry out the performance test.
6-3
6.3.1 Upgrading SMR
The SMR can be connected to the patient monitor through the SMR connector via a powered USB cable.
For details, see BeneVision N Series Patient Monitor Operator's Manual (P/N: 046-009995-00).
How to use WiFi functions: See BeneVision N Series Patient Monitor Operator's Manual (P/N:
046-009995-00).
The wireless signal will be affected by inaccuracy installation location of the antenna.
How to use the recorder: See BeneVision N Series Patient Monitor Operator's Manual (P/N:
046-009995-00).
How to use iView system functions: See BeneVision N Series Patient Monitor Operator's Manual (P/N:
046-009995-00).
NOTE
During installation, use a blade to cut off the seals for the USB, DVI and network interface at
the rear case so that the interface can stretch out from the rear case.
6-4
6.3.5 Upgrading Independent Display Function
Installation method: Refer to the corresponding section of this manual to install the related boards of
the independent display upgrade package in your patient monitor.
How to use the independent display function: See BeneVision N Series Patient Monitor Operator's
Manual (P/N: 046-009995-00).
NOTE
During installation, use a blade to cut off the DVI seal at the rear case so that the interface can
stretch out from the rear case.
You can upgrade the software with the System Update Tool (PN: 110-005042-00 PC Upgrade Tool)
through network. This tool can directly run on a PC. Through network or by connecting the patient
monitor to a PC via a crossover network cable, you can upgrade the following programs.
6-5
The programs of this monitor can also be upgraded through a specially authorized USB disk (which
contains the USB disk upgrade BIOS program PN:110-004854-00) or the following programs of the
monitor can also be upgraded.
System software
/ Large N12N15N17 system package /
package
ECG
Mindray monitoring algorithm package (full
/ configuration
function configuration) BF512
software
1. Click the executive program “SystemUpdateTool.exe” of the system upgrade tool software to display
the related prompt interface. Click to enter the input interface of the information
about SN.
6-6
2. Enter the SN information, and click to enter program installation location interface.
Select the corresponding folder for installation, and click to complete installation
Make sure that at least one network card is installed on the PC, and the PC is connected to the monitor
through the network card.
PC connected to the hub through a network cable: Connect one end of the network cable to the
network card slot of the PC and the other end to the hub slot.
Hub connected to the monitor through a network cable: The connection method is the same as
the above method. The hub has multiple slots, so multiple (at least 5) monitors can be
connected in this case and upgraded at the same time.
NOTE
To ensure correct upgrade, the IP address set using the following rule must be used before
running the upgrade program. The IP address must be set to 77.77.1.xx, but there are no
special requirements for the gateway and DNS. For example, the IP address is 77.77.1.13, and
the subnet mask is “255.255.255.0”.
Connect the monitor to the USB keyboard. When starting the monitor, constantly click ' F4+F5' or '*'
at the same time to enter the upgrade mode to perform upgrade;
When starting the monitor, use two or more fingers to continuously and rapidly tap the screen to
enter the upgrade mode to perform upgrade.
The software upgrade package of each product needs to be set according to the above configuration
requirements. The software upgrade package can only be set by the administrator and is also specially
managed by the administrator. System software upgrade settings:
1. Download the large software package of N12/N15/N17 system (the storage location is the model
package path), run the installed system (network) upgrade tool software, click Select A New Model
Package, select the "Merak.Tool" model package, click Open, and then click OK, as shown in the
following figures:
6-7
3
2. On the displayed machine type selection interface, select the machine type "Merak".
6-8
6.4.2 Guide to Software Upgrade Operations
6.4.2.1 System Software Upgrading Method
1. Enter the main interface for downloading of system upgrade, and click .
2. Select the prepared system software upgrade package file through browsing, check to ensure that
the selected downloading content (including the information such as the upgrade item, check sum,
version and description) is correct, and then click OK.
6-9
3. Confirm that the downloading network cable is connected correctly, make sure that the monitor has
been powered off, and click the Start hot key of the upgrade tool to enter the downloading
procedure of software.
1. First connect the SMR connection line to the multi-function interface of N12/N15/N17 main unit (the
system software has been upgraded, and the main unit is off), connect the downloading network
cable to the N12/N15/N17 main unit (the same as the connecting method for upgrade of the
N12/N15/N17 main unit), and confirm that all the connection lines are connected correctly.
2. Enter the main interface for downloading of system upgrade, click " ", and select
3. Upgrade the SMR upgrade program by referring to “System Software Upgrading Method”.
4. If the upgrade fails, check whether all the wires are connected correctly, and then perform upgrade
again.
Upgrade the module program file by referring to “System Software Upgrading Method”. When the
upgrade is completed, click the Stop button on the upgrade menu to stop the upgrade, remove the
network cable, turn off the monitor, and then restart it.
For the detailed operations of network program upgrade, refer to the help and instructions included in
the System Update Tool, or consult your service personnel.
Required tools:
USB disk: a common USB disk in the FAT format (e.g., the USB disk of Kingston, Netac or other models
with at least 2GB memory).
1. Create the following content under the root directory of the USB disk: UPGRADE_AMP\Merak.
2. Copy the upgrade BIOS program Merak_Installer.pkg (do not change this file name) to the
UPGRADE_AMP\Merak directory.
6-10
3. Copy the upgrade file (PKG or MPKG) to the UPGRADE_AMP\Merak directory.
6.4.3.2 Inserting the USB Disk into the USB port of the Monitor
Insert the prepared USB disk into anyone of the four (4) USB ports of the main control board. Do not insert
the USB disk into the USB port of the iView board.
Method 1: As pressing the on/off button of the monitor to start the monitor, use two or more fingers
to continuously and rapidly tap the touch screen to enter the upgrade mode.
Method 2: Connect the USB keyboard, and constantly click 'F2+F3' or 'F4+F5' or '*' at the same time to
power on the monitor and enable it to enter the upgrade mode; in this way, the user's upgrade file
selection interface can be accessed.
6.4.3.4 Selecting the File for Upgrade through the USB Disk
Only one upgrade package file is available at present. It is selected by default. If multiple upgrade
packages exist, they are displayed in the left and right columns, and a maximum of 16 upgrade
6-11
packages can be displayed. This upper limit cannot be exceeded. The up, down, left and right keys
can be used to switch and select the desired upgrade package.
Tap the area on the touch screen to select the upgrade program downward; or press
the “” direction key on the keyboard to select it;
Tap the area on the touch screen to select the upgrade program upward; or press
the “” direction key on the keyboard to select it;
Tap the area on the touch screen to select the upgrade program leftward; or press
Tap the area on the touch screen to select the upgrade program rghtward; or press
the “” direction key on the keyboard to select it;
Tap the area on the touch screen to confirm the selected upgrade program; or press
the Enter key on the keyboard to confirm it.
When the interface below is displayed, the current upgrade is completed. The upgrade takes effect after
the monitor is powered off and restarted.
CAUTION
Disconnect the patient monitor from the patient and make sure that important data are saved
before upgrade.
Do not shut down or power off the equipment when upgrading the BIOS program and FPGA
program. Otherwise, the equipment may break down.
6-12
Program upgrade should be performed by qualified service personnel only. Indicates a
potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or
product/property damage.
NOTE
After upgrading the BIOS program, you have to upgrade system program and other programs
to ensure their compatibility.
Make sure the version of the upgrade package is your desired one. If you want to obtain the
latest upgrade package, contact Mindray Customer Service Department.
MID number/MAC address (for example: 000F140839AE). To get the MID number, select : Main Menu
→ License (in the System column).
1. Unzip the PMLS.zip file. Then you would get a folder named PMLS.
NOTE
The U disk should be FAT32 format.
3. Plug the USB disk into the BeneVision N series patient monitor.
4. In the interface of BeneVision monitor, choose Main Menu → License (in the System column) →
External, and then click the Install button.
6-13
FOR YOUR NOTES
14
7 Repair and Disassembly
7.1 Tools
During disassembly and repair, the following tools may be required:
Phillips screwdrivers
Tweezers
M3 sleeve
Stop monitoring the patient, turn off the monitor and disconnect all the accessories and peripheral
devices.
Disconnect the AC power supply and take out all the batteries.
if the SMR is connected, disconnect the SMR from the monitor and then remove all the parameter
modules in it.
CAUTION
Eliminate static electricity before the disassembly. When removing some parts with the
electrostatic sensitive mark, wear protective devices such as electrostatic ring or
anti-electrostatic gloves, lest the parts would be damaged.
Properly connect and route the cables and wires when reassembling the equipment to avoid
pinched hoses and electrical short circuits.
Use specified screws to reassemble 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.
Before removing assemblies, make sure that all the connection lines have been unplugged.
During removal, note to avoid breaking the connection line by pulling or damaging the
connector.
7-1
CAUTION
Place the removed screws and other parts separately by category so that they can be used in
the re-installation. Do not drop, contaminate or lose them.
1. Remove the power plug anti-pull hook from the rear case of the monitor.
2. Use a tweezer to pry up the four screw covers at the four corners of the rear case and loosen and remove the
four M3×8 screws under them.
7-2
7.3.2 Disconnecting the Base
NOTE
Be sure to place the monitor face up when disconnecting the base. To lay the monitor face
down, make sure that the surface is non-abrasive and static-free, lest the touch screen would
be scratched. Be sure to remove the base first before proceeding with other parts.
1. As shown in the figure below, place the monitor face up, unscrew the M4×8 screws (5 for the N12
series and 6 for the N15N17 series) from the bottom case;
For the N12 series machines, the base assembly can be removed when the base is pulled out.
7-3
For the N15N17 series machines, the base assembly can be removed when the connection line
connected to the battery interface board of main board is pulled out.
J24
J20
NOTE
Be sure to pull out the base with proper force, without damaging the cables and connectors.
NOTE
Before placing the monitor face down, make sure that the desktop is flat, without foreign
matters, lest the screen would be damaged.
Release the clip (if any) on the connection line socket before disconnecting the connection line.
Be sure to pull out the base with proper force, without damaging the cables and connectors.
For the N12 series machines, remove the connection line for the LCD screen and the connection
line for the small board of front case.
For the N15N17 series machines, remove the connection line for the touch screen, connection
line for the LCD screen and the connection line for the small board of front case.
7-4
2. Lift the rear case assembly to separate it from the front case assembly.
NOTE
As shown in the above figure, there are two types of front case assemblies (NLT and SHARP),
which are different in the cabling way.
N12
7-5
N15
N17
7-6
7.4 Further Disassembly of the Front Case Assembly
7.4.1 Removing the PowerSwitch Board
1. Remove the connection line on the powerswitch board.
2. Remove the two PT3×8 screws and take out the powerswitch board.
2PCS PT3X8
NOTE
Use proper force to remove the cable carefully lest it would be broken.
During installation, press the board to the silicone keypad direction by aligning with the front
case board positioning rib.
Note to control the torsion when tightening the twoPT3×8 screws again, avoiding screw
sliding.
2. Remove the two PT3×8 screws and take out the alarm lamp and light sensor board.
2PCS PT3X8
Connection
line socket
NOTE
Use proper force to remove the cable carefully lest it would be broken.
During installation, press the board to the alarm lamp shade direction by aligning with the
7-7
front case board positioning rib.
Note to control the torsion when tightening the two PT3×8 screws again, avoiding screw
sliding.
Cable tie
(N12-NLT) (N12-SHARP)
Cable tie
(N15-NLT) (N15-SHARP)
Cable tie
(N17-NLT) (N17-SHARP)
CAUTION
Prevent pressure on the front face of display screen during disassembly.
Remove the LCD screen assembly in an environment as dust-free as possible; the display screen
7-8
and touch screen are integrated materials and cannot be disassembled. Indicates a potential
hazard or unsafe practice that, if not avoided, could result in minor personal injury or
product/property damage.
2. Pull the two clips in as indicated in the figure below to separate it from the rear case, and pull out the
recorder at the same time.
3. After the recorder is pulled out, take down the recorder connection line from the positioning rib, and
pull out the socket respectively. Then, the recorder can be removed.
Clips
NOTE
Use proper force to remove the cable carefully lest it would be broken.
7-9
7.5.2 Further Disassembly of the Recorder
1. First remove one PT2X6 screw, and take down the grounding piece at the same time.
M2X6
2. Release the two clips backward and take out the recorder drive board. Pay attention to the snap in
the front.
Snap
3. First pull up the pressing buckle by about 1 mm to remove the flexible cable; remove the connection
line from the drive board to the button board; unscrew one PT2×6 screw, and remove the ground
cable of the drive board. Remove the recorder drive board.
Pressing buckle
4. Remove the other PT2×6 screw and take out the thermal printhead.
5. Loosen and remove the two PT2×6 screws and remove the button board of recorder.
7-10
Recorder button
NOTE
Use proper force to remove the cable carefully lest it would be broken.
2. Tear the MPAN antenna fixing piece. Then, the MPAN antenna can be removed.
7-11
NOTE
Use proper force to remove the cable carefully lest it would be broken.
2. Remove the adhesive tape fixing the antenna, and tear off the Wi-Fi sticker antenna.
7-12
3. Pull out the Wi-Fi antenna plug from the board; unscrew the three M2X4 screws, and separate the
Wi-Fi module from the Wi-Fi support board.
Wi-Fi
Wi-Fi
support
NOTE
Use proper force to remove the cable carefully lest it would be broken.
Use proper force to separate the board carefully, lest the board socket and golden
finger part would be damaged. Provides application tips or other useful information to
ensure that you maintain your product better.
7-13
N12
1. Remove the connection line of battery interface board from the main board end, and then take out
the connection line of internal module rack COM board; unscrew the four M3X6 screws, and force
upward to take out the battery cavity assembly as indicated in the figure.
J10
J20
Connection line of
internal module rack COM
board
2. Loosen and remove the two M3X6 screws, and remove the battery interface board.
3. Loosen and remove the five M3X6 screws, and force upward vertically to remove the internal module
rack assembly as indicated in the figure.
7-14
4. Place the face of the removed module rack assembly board up. First unscrew the two M2.5X6 screws
on the SMR interface, the two PT3X8 screws, and the six M3X6 screws in turn, and then take down
the internal module rack COM board.
M3X6
M2.5X6
PT3X8
5. Turn over the removed internal module rack COM board, and take down the four POGO PIN silicon
cases.
N15N17
1. First remove the connection line of internal module rack COM board; unscrew the four M3X6 screws
according to the positions shown below, and loosen one captive screw; force upward vertically to
remove the module rack assembly as indicated in the figure.
7-15
2. Place the face of the removed module rack assembly board up. First unscrew the two M2.5X6 screws
on the SMR interface, the two PT3X8 screws, and the seven M3X6 screws in turn, and then take down
the internal module rack COM board.
M2.5X6
PT3X8
M3X6
3. Turn over the removed internal module rack COM board, and take down the six POGO PIN silicon
cases.
7-16
7.5.6 Removing the Main Support Assembly
N12
1. Pull out the speaker connection line, unscrew the two M3X6 screws, and take down the speaker
assembly.
2. Loosen and remove the five M3X6 screws, and vertically take out the main support assembly.
3. As shown in the figure below, place the face of the removed main board of main support up, pull out
the connection line from the main control board to the ACDC and insert it in the main board end,
unscrew the two DVI stud screws and four M3X6 screws, and then take out the main control board.
7-17
Connection line from the
main control board to
the ACDC
DVI stud screw
4. Turn over the main support with the main control board removed, and place its face up; remove the
connection line from the main control board to the ACDC, and insert it into the ACDC power supply
end; remove the power cord from the AC input to the ACDC, and insert it into the ACDC power
supply end; unscrew four M3X6 screws, and take down the power board.
5. Loosen and remove two M3X6 screws, and take out the recorder cover; unscrew one M3X6 screw,
and take out the power cord from the AC input to ACDC.
Recorder cover
7-18
N15N17
1. Pull out the speaker connection line, loosen and remove the two M3X6 screws, and take down the
speaker assembly.
2. As shown below, for the N15 series machine, loosen and remove the five M3X6 screws, and vertically
take out the main support assembly.
(N15)
As shown below, for the N17 series machine, loosen and remove the six M3X6 screws, and vertically take
out the main support assembly.
(N17)
7-19
3. As shown in the figure below, place the face of the removed main board of main support up, pull out
the connection line from the main control board to the ACDC and insert it in the main board end,
loosen and remove the two DVI stud screws and four M3X6 screws, and then take out the main
control board.
4. Turn over the main support with the main control board removed, and place its face up; remove the
connection line from the main control board to the ACDC, and insert it into the ACDC power supply
end; remove the power cord from the AC input to the ACDC, and insert it into the ACDC power
supply end; loosen and remove four M3X6 screws, and take down the power board.
Power board
5. Cut off the cable tie on the connection line, loosen and remove the two M3X6 screws, and take out
the recorder cover; loosen and remove one M3X6 screw, and take out the power cord from the AC
input to ACDC.
7-20
Cable tie
NOTE
Do not injure the cable when cutting the cable tie.
2. Remove the two iView board connection lines and the internal module rack connection line, loosen
and remove the four M3X6 screws, and then take out the iView board assembly.
7-21
Two iView board connection lines
3. Place the face of the removed iView board assembly board up, and take down the SSD hard disk by
pressing the SSD hard disk clips; loosen and remove the four M3X6 screws, and take down the iView
board.
4. As shown below, place up the face of the iView board side with the computer module, loosen and
remove the four M2X6 screws, and separate the computer module from the iView support board.
Computer
module
iView support
board
7-22
7.5.8 Removing the Independent Display Board Assembly (N17 Series)
1. First screw out the two DVI stud screws.
2. Remove the independent display board connection line and the internal module rack connection line,
loosen and remove the four M3X6 screws, and then take out the independent display board
assembly.
3. Loosen and remove the four M3X6 screws, and take down the independent display board.
7-23
7.5.9 Removing the Handle
1. Place the face of the rear case handle down, loosen and remove the two PT 3X8 screws, forcibly
release the four clips on the top cover of rear case, and push down to take out the top cover of rear
case.
2. Pry open the two handle positioning pins to the middle direction, and take out the handle.
7-24
7.6 Further Disassembly of the Base Assembly
N12
Take out the battery door connecting belt from the through hole, and remove the battery door.
N15N17
1. Loosen and remove the two M3X6 screws, and remove the battery interface board.
2. As shown below, open the battery door, insert a a piece of cloth into the gap between the battery
door and the base, and forcedly press down to take out the battery door.
7-25
7.7 Disassembling the Module Rack
1. Removing the handle and hooks
As shown in the following figure, loosen and remove the eight M3X10 cross recessed
countersunk head screws, and remove the hooks.
M3X10 screw
As shown in the following figure, loosen and remove the three M3×8 cross recessed countersunk
head screws, and remove the handle.
M3X8 screw
As shown in the following figure, use a tweezer to take out the six screw covers on the rear case,
loosen and remove the six M3X16 cross recessed pan head screw, and separate the front case from
the rear case.
7-26
Screw cover
M3X16 screw
Loosen and remove the two M3X8 cross recessed pan head screws, pull out the connection line
between the interface board and the internal module rack COM board, and then take out the
interface board.
M3X8 screw
Pull out the connection line between the module rack antenna and the internal module rack COM
board, loosen and remove the seven M3X8 cross recessed pan head screws on the internal module
rack COM board, and take down the eight POGO PIN silicon cases of module rack.
7-27
Module rack antenna
M3X6 screw
As shown in the figure, use tweezers to remove the screw for the back end terminal of the
module; use a small flat-bladed screwdriver to remove the wrench; use a Phillips screwdriver to
remove the front panel screw. Then, the front panel of module can be pulled out.
Use tweezers to remove the Remove the wrench Remove the screw
terminal screw
7-28
As shown in the following figure, loosen and remove the screw between the front panel and the
bracket, and unplug the air tube at the air nozzle. Then the front panel can be removed.
As shown in the following figure, loosen and remove the board screws, pull out the pump and valve
connection line and NIBP air tube. Then, the parameter board can be removed.
As shown in the following figure, remove the blood oxygen board screws, and then pull out the blood
oxygen board.
As shown in the following figure, remove the infrared board connection line, and then remove the
infrared board.
7-29
Pull out from this end
As shown in the following figure, cut off the cable tie, unplug the pump power line and NIBP air
tube, and then remove the pump.
As shown in the figure, unplug the valve power line and NIBP air tube, use a flat-bladed
screwdriver to poke the slots at two sides of the valve, and then remove the valve assembly.
7-30
8 Parts
This chapter lists the exploded views and material codes of the parts including the monitor's main unit,
SMR and parameter module. It helps the engineer to identify the parts during disassembly of the patient
monitor and spare parts replacement.
Parts List
8-1
No. Name and Specification Qty Material Code
8-2
Parts List
4 MK hood 1 049-001214-00
8-3
8.1.3 N12-SHARP Front Housing Assembly
Exploded View
Parts List
4 MK hood 1 049-001214-00
8-4
No. Name and Specification Qty Material Code
14 CORE O.D=21.5mmI.D=9.5mm 1 /
8-5
plated with green color zinc
Parts List
8-7
8.1.6 N12 Battery Cavity Assembly (FRU)(115-044504-00)
Exploded View
Parts List
8-8
8.1.7 N12 Module Rack Body Assembly (FRU) (115-044507-00)
Exploded View
Parts List
5 Spring 8 6800-20-50388
8-9
8.2 N 15 Parts
8.2.1 N15 Whole Unit
Exploded View
Parts List
4 Screw / /
8-10
8.2.2 N15-NLT Front Housing Assembly
Exploded View
Parts List
5 MK hood 1 049-001214-00
8-11
No. Name and Specification Qty Material Code
9 CORE O.D=21.5mmI.D=9.5mm 1 1 /
8-12
Parts List
5 MK hood 1 049-001214-00
9 CORE O.D=21.5mmI.D=9.5mm 1 1 /
8-13
8.2.4 N15 Rear Housing
Exploded View
Parts List
4 N15 handle 1
8-14
7 Handle right damping block, N15 1 /
12 Speaker bracket 1
15 Screw / /
8-15
8.2.5 N15 Rear Housing Assembly (FRU) (115-044541-00)
Exploded View
Parts List
8-16
8.2.6 N15 Base Assembly (FRU)(115-044543-00)
Exploded View
Parts List
8-17
8.2.7 N15N17 Module Rack Body Assembly (FRU) (115-044546-00)
Exploded View
Parts List
3 Spring 12 6800-20-50388
8-18
8.3 N17 Parts
8.3.1 N17 Whole Unit
Exploded View
Parts List
3 Screw / /
8-19
8.3.2 N17-NLT Front Housing Assembly
Exploded View
Parts List
4 MK hood 1 049-001214-00
9 CORE O.D=21.5mmI.D=9.5mm 1 1 /
8-20
No. Name and Specification Qty Material Code
8-21
Parts List
4 MK hood 1 049-001214-00
9 CORE O.D=21.5mmI.D=9.5mm 1 1 /
8-22
8.3.4 N17 Rear Housing
Exploded View
Parts List
8-23
No. Name and Specification Qty Material Code
N17 MainBoard(FRU/SW<N17/OEM>/iView&ID)---used
051-002718-00-06
for OEM
5 Speaker bracket 1
7 MK speaker foam 1
18 N17 handle 1
8-24
8.3.5 N17 Rear Housing Assembly (FRU)( 115-044548-00)
Exploded View
Parts List
8-25
8.3.6 N17 Base Assembly (FRU)( 115-044550-00)
Exploded View
Parts List
8-26
8.3.7 Independent Display Upgrade Package (Without Mainboard)
(115-044554-00)
Exploded View
Parts List
Small cross recessed pan head GB9074.5-88 M3X6 with pad and
2 4 /
plated with green color zinc
8-27
8.3.8 Independent Display Upgrade Package (With Mainboard)
(115-044579-00)
Exploded View
Parts List
Small cross recessed pan head GB9074.5-88 M3X6 with pad and
3 4 /
plated with green color zinc
8-28
8.3.9 Independent Display Assembly
Exploded View
Parts List
Small cross recessed pan head GB9074.5-88 M3X6 with pad and
3 4 /
plated with green color zinc
8-29
8.3.10 iView Module Assembly(Win7 system)
Exploded View
8-30
Parts List
8-31
8.3.11 iView Module Assembly(Win10 system)
Exploded View
8-32
Parts List
8-33
8.4 External Satellite Module Rack (SMR)
Exploded View
Parts List
8-34
8.5 M51C Module
Exploded View
Parts List
1
M51C-ME, 5L5P, MR/NC-SPO2, IBP, MPM I/F 051-002482-01
1 selected
M51C-FF (Ext Arr /12 Lead ST /Glasgow_12) 051-002483-00-00
from 4
8-35
No. Name and Specification Qty Material Code
selected
M51C module communication backplane(no IBP) 051-002383-00-01
from 2
6 Fixing base 2 /
8 Spanner (T8) 2 /
10 Terminal screw 2 /
8-36
No. Name and Specification Qty Material Code
8-37
A Electrical Safety Inspection
The following electrical safety tests are recommended as part of a comprehensive preventive maintenance
program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous
to either the patient or the operator. Additional tests may be required according to local regulations.
All tests can be performed using commercially available safety analyzer test equipment. These procedures
assume the use of a 601PROXL International Safety Analyzer or equivalent safety analyzer. Other popular
testers complying with IEC 60601-1 used in Europe such as Fluke, Metron, or Gerb may require
modifications to the procedure. Follow the instructions of the analyzer manufacturer.
The consistent use of a safety analyzer as a routine step in closing a repair or upgrade is emphasized as a
mandatory step if an approved agency status is to be maintained. The safety analyzer also proves to be an
excellent troubleshooting tool to detect abnormalities of line voltage and grounding, as well as total
current loads.
A-1
A.2 Device Enclosure and Accessories
A.2.1 Visual Inspection
Test Item Acceptance Criteria
A-2
The following conditions apply: L1 and L2 Open.
Preparation
1. First select the test current that will be used for performing the Protective Earth Resistance test by
pressing AMPERES (SOFT KEY 3).
2. Connect the test lead(s) between the RED input jack and the GREEN input jack.
3. Press CAL LEADS. The 601PRO will measure the lead resistance, and if less than 0.150 Ohms, it will
store the reading and subtract it from all earth resistance readings taken at the calibrated current.
If the calibration fails, the previously stored readings will be used until a passing calibration has occurred.:
WARNING
During Earth Resistance testing, the DUT must be plugged into the 601PRO front outlet. If
the DUT fails Earth Resistance, discontinue tests and label the device defective.
2. Attach the 601PRO RED input lead to the device’s Protective Earth terminal or an exposed metal area.
4. Press SOFT KEY 3 to select a test current (1AMP, 10AMP, or 25AMP). The selected test current is
displayed in the upper right corner of the display.
5. Press START TEST to start the test. The test current is applied while resistance and current readings are
taken. This takes approximately 5 seconds.
6. Press the print data key at any time to generate a printout of the latest measurement(s).
A-3
NOTE
When "Over" is displayed for Ohms, this signifies that a valid measurement was not
obtained because either an open connection was detected or that the measurement was not
within range. Readings greater than 9.999 Ohms will be displayed as Over.
In Case of Failure
Once it reaches the limitation, stop using and inform the Customer Service Engineer for analysis and
disposal.
LIMITS
ALL COUNTRIES R = 0.2 Ω Maximum
Earth Leakage Current, leakage current measured through DUT outlet Earth
Earth Leakage Current AP-EARTH (ALL Applied Parts connected to Earth), leakage current measured
through DUT outlet Earth
There is no need to attach a test lead; the 601PRO automatically connects the measuring device internally.
1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel
outlet, and turn on the device.
2. Attach the device's applied parts to the 601PRO applied part terminals if applicable.
3. Press shortcut key 4.The Earth Leakage test appears on the display, and the test begins immediately:
SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse.
A-4
SOFT KEY 2 toggles the DUT outlet from Earth to No Earth.
4. Press the print data key at any time to generate a printout of the latest measurement.
In Case of Failure
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or
owner to correct any deviations. As a work around, check the other outlets to see if they could be
used instead.
If the leakage current measurement tests fail on a new unit and if situation can not be corrected,
submit a Safety Failure Report to document the system problem. Remove unit from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.
LIMITS
For IEC60601-1,
A-5
A.6 Patient Leakage Current
Patient leakage currents are measured between a selected applied part and mains earth. All
measurements have a true RMS only response.
Preparation
WARNING
If all of the applied parts correspond to the instrument type, the applied parts will be tied
together and one reading will be taken. If any of the applied parts differ from the
instrument type, all applied parts will be tested individually, based on the type of applied
part. This applies to Auto and Step modes only.
1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel
outlet, and turn on the device.
3. Press shortcut key 6. The Patient Leakage test is displayed, and the test begins immediately.
4. Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part leakage current.
5. Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the
601PRO.
6. Press the print data key at any time to generate a printout of the latest measurement.
A-6
In Case of Failure
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or
owner to correct any deviations. As a work around, check the other outlets to see if they could be
used instead.
If the leakage current measurement tests fail on a new unit and if situation can not be corrected,
submit a Safety Failure Report to document the system problem. Remove unit from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.
LIMITS
The following outlet conditions apply when performing the Mains on Applied Part test.
Normal Polarity;
Reversed Polarity
Preparation
To perform a calibration from the Mains on Applied Part test, press CAL (SOFT KEY 2).
1. Disconnect ALL patient leads, test leads, and DUT outlet connections.
A-7
If the calibration fails, the previously stored readings will be used until a passing calibration has
occurred. Also, the esc/stop key has no effect during calibration.
3. When the calibration is finished, the Mains on Applied Part test will reappear.
WARNING
A 2-beep-per-second signal indicates high voltage present at the applied part terminals
while a calibration is being performed.
High voltage is present at applied part terminals while measurements are being taken.
1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601
3. Attach the red terminal lead to a conductive part on the DUT enclosure.
5. Select the desired outlet configuration and applied part to test using the appropriate SOFT KEYS:
7. Press the print data key to generate a printout of the latest measurement.
NOTE
If all of the applied parts correspond to the instrument type, the applied parts will be tied
together and one reading will be taken. If any of the applied parts differ from the
instrument type, all applied parts will be tested individually, based on the type of applied
part. This applies to Auto and Step modes only.
A-8
In Case of Failure
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or
owner to correct any deviations. As a work around, check the other outlets to see if they could be
used instead.
If the leakage current measurement tests fail on a new unit and if situation can not be corrected,
submit a Safety Failure Report to document the system problem. Remove unit from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.
LIMITS
Preparation
1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel
outlet, and turn on the device.
3. Define the Lead Types from the View Settings Option (refer to: Lead Type Definitions in Section 5 of
this chapter).
4. Press shortcut key 8. The Patient Auxiliary Current test is displayed, and the test begins immediately.
Display values are continuously updated until another test is selected.
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6. Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part leakage current:
7. Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the
601PRO:
8. Press the print data key at any time to generate a printout of the latest measurement.
In Case of Failure
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or
owner to correct any deviations. As a work around, check the other outlets to see if they could be
used instead.
If the leakage current measurement tests fail on a new unit and if situation can not be corrected,
submit a Safety Failure Report to document the system problem. Remove unit from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.
LIMITS
A-10
ELECTRICAL SAFETY INSPECTION FORM
Overall assessment:
Location: Technician:
Normal
____μA
condition(NC) Max:
5 Earth Leakage NC: 5mA
□BF____μA
Normal Max:
condition(NC) □CF____μA CF applied part:
Patient Leakage
6 NC:10μA, SFC: 50μA
Current □BF____μA
Single Fault BF applied part:
condition(SFC) □CF____μA NC:100μA, SFC: 500μA
□BF____μA
Max:
7 Mains on Applied Part Leakage CF applied part: 50μA
□CF____μA
BF applied part: 5000μA
□BF____μA
Max:
Normal condition(NC)
Patient □CF____μA CF applied part:
8 Auxiliary NC:10μA, SFC: 50μA
□BF____μA
Current Single Fault BF applied part:
condition(SFC) □CF____μA NC:100μA, SFC: 500μA
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Unopened repair type Test item: 1, 2, 3
Opened repair type, not replace the power part including Test item: 1, 2, 3, 4
transformer or patient circuit board
Opened repair type, replace the power part including Test item: 1, 2, 3, 4, 5
transformer
Location: Technician:
Pass/Fai
INSPECTION AND TESTING Limit
l
Normal
____μA
condition(NC) Max:
5 Earth Leakage NC: 5mA
□BF____μA
Normal Max:
condition(NC) □CF____μA CF applied part:
Patient Leakage
6 NC:10μA, SFC: 50μA
Current □BF____μA
Single Fault BF applied part:
condition(SFC) □CF____μA NC:100μA, SFC: 500μA
□BF____μA
Max:
7 Mains on Applied Part Leakage CF applied part: 50μA
□CF____μA
BF applied part: 5000μA
□BF____μA
Max:
Normal condition(NC)
Patient □CF____μA CF applied part:
8 Auxiliary NC:10μA, SFC: 50μA
□BF____μA
Current Single Fault BF applied part:
condition(SFC) □CF____μA NC:100μA, SFC: 500μA
A-12
PN: 046-010023-00 (4.0)