BeneVision N Series Service Manual Ver 3.0 August 2017

In ntellec ctual Prope P erty Statem ment SHENZHEN MINDRAY M BIO O-MEDICAL E LECTRONICS S CO., LTD. (h hereinafter callled Mindray) owns o the intellectua al property righ hts to this prod duct and this manual. m This manual m may reefer to informa ation protected by copyrights c or patents p and do oes not conve ey any license under the pattent rights of Mindray, nor the t rights of otthers. Mindrayy does not ass sume any liabiility arising outt of any infringementss of patents or other rights o of third parties..

,,

and

are the registtered tradema arks or tradem marks owned by b

hina and otherr countries. Mindray in Ch

Re evisio on His story This manual has h a revision number. This revision number changes whenever w the manual is upd dated due to software or technica al specification n change. Con ntents of this manual m are subbject to chang ge without prior notice. n  Version

n number

 Rele ase time: t

3.0 Augest 2017

© 2016 -2017 7 Shenzhen Mindray Bio-Me edical Electron nics Co., Ltd. All A rights reserrved.

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: 

User maintenance:

888888



Manage Configuration:

315666



Factory maintenance:

332888



Demo mode:

2088

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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 2 Operation Theory ...2-1 2.1 Overview ...2-1 2.2 Product System Architecture ...2-1 2.2.1 Main Control Board ...2-3 2.2.2 Internal Module Rack COM Board ...2-3 2.2.3 Power Architecture ...2-4 2.2.4 Independent Display Board (for the N17 Only) ...2-5 2.2.5 iView Module (for the N17 Only) ...2-5 2.2.6 Alarm LAMP Board...2-5 2.2.7 Power Switch Board ...2-5 2.3 Data Logic Flow ...2-5 3 WLAN Installation ...3-1 3.1 Introduction ...3-1 3.2 Network Deployment Process...3-1 3.2.1 List of outputs...3-2 3.3 Network Requirements ...3-4 3.4 Network Verification ...3-5 3.4.1 Tools and Resources...3-5 3.4.2 Wi-Fi Signal Calibration...3-6 3.4.3 Network Verification Process ...3-6 3.5 Network Coverage Assessment with Patient Monitors ...3-9 3.6 Recommended Devices for WLAN ... 3-10 3.7 Setting Wireless Parameters for Patient Monitors ... 3-10 3.8 Troubleshooting ... 3-14 4 Testing and Maintenance ...4-1 4.1 Introduction ...4-1 4.1.1 Test Equipment ...4-1 4.1.2 Test Report ...4-1 4.1.3 Preventative Maintenance...4-1 4.1.4 Recommended Frequency ...4-2 4.2 Preventative Maintenance Procedures ...4-3

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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 ... 4-12 4.4.1 ECG Tests ... 4-12 4.4.2 Resp Performance Test... 4-13 4.4.3 SpO2 Test ... 4-13 4.4.4 NIBP Tests ... 4-13 4.4.5 Temp Test ... 4-14 4.4.6 IBP Tests ... 4-14 4.4.7 C.O. Test ... 4-16 4.4.8 Mainstream CO2 Tests ... 4-16 4.4.9 Sidestream and Microstream CO2 Tests ... 4-17 4.4.10 AG Tests ... 4-17 4.4.11 EEG Test ... 4-18 4.4.12 BIS Test... 4-19 4.4.13 RM Test ... 4-20 4.4.14 CCO/SvO2 Tests ... 4-21 4.4.15 PiCCO Test ... 4-22 4.4.16 NMT Tests ... 4-25 4.5 Nurse Call Relay Performance Test ...4-26 4.6 Analog Output Performance Test ...4-26 4.7 Electrical Safety Tests ... 4-27 4.8 Recorder Check ... 4-28 4.9 Network Print Test ... 4-28 4.9.1 Device Connection and Setup... 4-28 4.10 Device Integration Check ... 4-29 4.10.1 Device Connection and Setup ... 4-29 4.10.2 Device Integration Function Test ...4-32 4.10.3 Installation and Test Report ...4-39 4.11 Battery Check ... 4-40 4.12 Mounting Check ... 4-40 4.12.1 Safety check ... 4-40 4.12.2 Overall Test and Check of Installed System ... 4-40 4.13 Factory Maintenance ... 4-41 4.13.1 Accessing Factory Maintenance Menu... 4-41 4.13.2 Monitor Information ...4-41 4.13.3 Production Test ... 4-42 4.13.4 Setup... 4-42 4.13.5 Debug ... 4-43 4.13.6 Power Info ... 4-43 4.13.7 ClinicalData ... 4-43

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4.13.8 Transferring Clinical Data ... .4-44 4.13.9 Software Version ... 4-44 4.13.10 Monitor Information ...4-44 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 ...5-9 5.6.9 Software Upgrade Problems ...5-10 5.6.10 Device Integration Failures ... 5-11 6 Upgrade ...6-1 6.1 Overview ...6-1 6.2 Upgrade of Parameter Function Modules ...6-2 6.3 Upgrade of Functional Assemblies ...6-5 6.3.1 Upgrading SMR ...6-6 6.3.2 Upgrading Wireless Network Functions ...6-6 6.3.3 Upgrading Recorder ...6-6 6.3.4 Upgrading iView System ...6-7 6.3.5 Upgrading Independent Display Function ...6-7 6.4 Upgrading Software ...6-8 6.4.1 Description of Network Upgrade Tool ...6-9 6.4.2 Guide to Software Upgrade Operations ... 6-12 6.4.3 Guide to Upgrade through a USB Disk ...6-14 6.5 Upgrading CAA license function ... 6-17 7 Repair and Disassembly...7-1 7.1 Tools ...7-1 7.2 Preparations for Disassembly ...7-1 7.3 Whole Unit Disassembly ...7-2 7.3.1 Basic Disassembly ...7-2 7.3.2 Disconnecting the Base ...7-3 7.3.3 Separating the Front and Rear Half of the Monitor ...7-4

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7.4 Further Disassembly of the Front Case Assembly ...7-8 7.4.1 Removing the PowerSwitch Board ...7-8 7.4.2 Removing the Alarm Lamp and Light Sensor Board ...7-8 7.4.3 Removing the Screen Assembly Connection Line ...7-9 7.5 Further Disassembly of the Rear Case Assembly... 7-10 7.5.1 Removing the Recorder ...7-10 7.5.2 Further Disassembly of the Recorder ... 7-11 7.5.3 Removing the MPAN Board ...7-12 7.5.4 Removing the WiFi Module ...7-13 7.5.5 Removing the Internal Module Rack Assembly ... 7-14 7.5.6 Removing the Main Support Assembly ... 7-18 7.5.7 Removing the iView Board Assembly (N17 Series)... 7-22 7.5.8 Removing the Independent Display Board Assembly (N17 Series) ...7-24 7.5.9 Removing the Handle ...7-25 7.6 Further Disassembly of the Base Assembly ...7-25 7.7 Disassembling the Module Rack... 7-26 7.8 Disassembling the M51C Module ...7-29 8 Parts ...8-1 8.1 N12 Parts ...8-1 8.1.1 N12 Whole Unit ...8-1 8.1.2 N12-NLT Front Housing Assembly ...8-3 8.1.3 N12-SHARP Front Housing Assembly ...8-5 8.1.4 N12 Rear Housing ...8-6 8.1.5 N12 Rear Housing Assembly (FRU)(115-044499-00) ...8-8 8.1.6 N12 Battery Cavity Assembly (FRU)(115-044504-00) ...8-9 8.1.7 N12 Module Rack Body Assembly (FRU) (115-044507-00) ...8-10 8.2 N 15 Parts ... 8-11 8.2.1 N15 Whole Unit ... 8-11 8.2.2 N15-NLT Front Housing Assembly ...8-12 8.2.3 N15-SHARP Front Housing ...8-14 8.2.4 N15 Rear Housing ... 8-16 8.2.5 N15 Rear Housing Assembly (FRU) (115-044541-00) ...8-18 8.2.6 N15 Base Assembly (FRU)(115-044543-00) ...8-19 8.2.7 N15N17 Module Rack Body Assembly (FRU) (115-044546-00) ...8-20 8.3 N17 Parts ... 8-21 8.3.1 N17 Whole Unit ... 8-21 8.3.2 N17-NLT Front Housing Assembly ...8-22 8.3.3 N17-SHARP Front Housing ...8-23 8.3.4 N17 Rear Housing ... 8-25 8.3.5 N17 Rear Housing Assembly (FRU)( 115-044548-00) ...8-27 8.3.6 N17 Base Assembly (FRU)( 115-044550-00) ...8-28 8.3.7 Independent Display Upgrade Package (Without Mainboard) (115-044554-00) ...8-29 8.3.8 Independent Display Upgrade Package (With Mainboard) (115-044579-00) ...8-30

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8.3.9 Independent Display Assembly ...8-31 8.3.10 iView Module Assembly ...8-32 8.4 External Satellite Module Rack (SMR) ... 8-34 8.5 M51C Module ... 8-35 A Electrical Safety Inspection ... A-1 A.1 Power Cord Plug ... A-1 A.2 Device Enclosure and Accessories ... A-2 A.3 Device Labeling ... A-2 A.4 Protective Earth Resistance ... A-2 A.5 Earth Leakage Test ... A-4 A.6 Patient Leakage Current ... A-6 A.7 Mains on Applied Part Leakage ... A-7 A.8 Patient Auxiliary Current ... A-9

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FOR YOUR NOTES

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1 Safetyy 1.1 Safety Informat I ion

DAN GER 

Indicates s an imminen nt hazard thatt, if not avoid ded, will resullt in death or serious injurry.

WA RNING R 

Indicates s a potential hazard or uns safe practice e that, if not avoided, a could d result in de eath or seriou us injury.

CAUT TION 

Indicates s a potential hazard or uns safe practice e that, if not avoided, a could d result in minor personal injury or pro oduct/properrty damage.

NOTE 

Provides s application tips or other useful inform mation to ensure that you get the most from your pro oduct.

1.1.1 Dange ers There are no dangers that refer r to the pro oduct in general. Specific “D Danger” statem ments may be e given in the re espective secttions of this m manual.

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1.1.2 Warnings WARN NING 

All installlation operattions, expans sions, change es, modifications and repaairs of this product are conducte ed by Mindray y authorized personnel.



There is high voltage inside the eq quipment. Ne ever disassem mble the equiipment before e it is disconne ected from th he AC power source.



When yo ou disassemb ble/reassemb ble a parameter module, a patient leakaage current te est ed again for monitoring. must be performed before it is use



d to a properrly installed power The equiipment must be connected p outlet w with protectiv ve earth contacts only. If I the installattion does nott provide for a protective eearth conduc ctor, disconne ect it from the power line and operate it on battery power, if posssible.



Dispose of the package material, o observing the e applicable waste w contro ol regulations s and keeping it out of child dren’s reach..

1.1.3 Cautio ons CAUT TION 

Make sure that no ele ectromagnetic c radiation in nterferes with h the perform mance of the equipme ent when prep paring to carrry out perform mance tests. Mobile phon ne, X-ray equipme ent or MRI devices are a p possible source of interference as theyy may emit hig gher levels off electromagn netic radiatio n.



Before connecting the equipment to the powerr line, check that t the voltaage and frequ uency ratings of o the power line are the s same as those e indicated on the equipm ment’s label or o in this man nual.



Protect the t equipmen nt from dama age caused by y drop, impac ct, strong vib bration or other mechaniical force durring servicing g.

1-2

1.1.4 Notes NOTE 

Refer to Operation Ma anual for deta ailed operatio on and other information..

1.2 2 Equipm ment Sym mbols Sym mbol

D Description

Symbol

Description Refer to instruuction

G General warning sign

manual/bookleet

S Serial number

Catalogue Nuumber

D Date of manuffacture

Manufacturer Protected agaainst vertically

U USB connecto or

falling f water ddrops per IEC 60529

B Battery indicattor

Direct currentt

E Equipotentialit ty

Alternating A cuurrent

D DEFIBRILLAT TION-PROOF TYPE

DEFIBRILLAT TION-PROOF

C APPLIED PART CF P

TYPE T BF APP PLIED PART

S Stop USB

Zero Z key

Calibrate key

N NIBP start/stop key

S Setup menu ke ey

Main menu keey

1-3

Symbol

Description

Symbol

Description

Check sensor

Graphical record

Gas outlet

Input/output

Output

Input

Dispose of in accordance to your

Authorised representative in the

country’s requirements

European Community

The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive. Note: The product complies with the Council Directive 2011/65/EU.

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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.

2.2 Product System Architecture All the N17/N15/N12 monitors have only one main unit: 

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.

Figure 2-1 System block diagram of the N17/N15/N12/N12C

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.

Figure 2-2 Diagram of the main control board

2.2.2 Internal Module Rack COM Board Two models of internal module rack COM boards are available. The N12 uses the 4-slot COM board, and the N15/N17 uses the 6-slot COM board. The internal module rack COM board is used to provide the interface for communication with the parameter module, the SMR interface and nurse call interface, and the MPAN module interface. Besides, the data forwarding FPGA and corresponding power circuit are also provided on the internal module rack COM board.

2-3

2.2.3 Power Architecture

Figure 2-3 Diagram of power architecture 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.

2.2.5 iView Module (for the N17 Only) As an embedded computer module, it provides the following external interfaces: the network interface, DVI interface, and the USB interface. It can connect to the keyboard, mouse, network cable, and display independently. The configuration of the iView module is mutually exclusive with that of the independent display module.

2.2.6 Alarm LAMP Board The LED alarm lamp and light sensor are provided on the board. The light sensor implements the ambient light detection and is used to adjust brightness of the LCD background light.

2.2.7 Power Switch Board There are the power switch and three indicators on the power switch board, which are the AC on-line indicator, battery indicator, and the power-on indicator.

2.3 Data Logic Flow

Figure 2-4 Data flow diagram 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.

3.2 Network Deployment Process If the hospital has built its WLAN, the installation process is illustrated as follows: Mindray/agent marketing or sales personnel

A0 Provide network requirements

Mindray headquarters

A1 Communicate with the hospital about intention to order

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 A4 Sign the contract

A5 Install the device and confirm system operation

Figure 3-1 Network Deployment Process

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