BeneView T1 Service Manual Ver 2.0 Nov 2011

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.

,

, and

are the registered trademarks or trademarks owned by

Mindray in China and other countries.

Revision History This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. „

Version number

2.0

„

Release time:

Novermber 2011

© 2011 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: „

User maintenance:

„

Manage Configuration: 315666

„

Factory maintenance:

332888

„

Demo mode:

2088

888888

II

Contents 1 Safety... 1-1 1.1 Safety Information ... 1-1 1.1.1 DANGER ... 1-1 1.1.2 Warnings ... 1-2 1.1.3 Cautions ... 1-2 1.1.4 Notes ... 1-2 1.2 Equipment Symbols ... 1-3 2 Theory of Operation ... 2-1 2.1 Introduction... 2-1 2.1.1 Front View... 2-1 2.1.2 Left View... 2-2 2.1.3 Right View ... 2-3 2.1.4 Bottom View ... 2-4 2.2 System Structure ... 2-4 2.2.1 Main Unit ... 2-5 2.2.2 External Parameter Modules ... 2-7 3 Unpacking and Installation ... 3-1 3.1 Unpacking the Equipment... 3-1 3.2 Preparation for Installation... 3-1 3.2.1 Preparation for Installation Site... 3-1 3.2.2 Electrical Requirements ... 3-3 3.3 Monitor Installation... 3-4 3.4 Preparation for Power On... 3-4 4 Hardware and Software Upgrade... 4-1 4.1 Hardware Upgrade ... 4-1 4.1.1 Upgrade Package... 4-1 4.1.2 Hardware Upgrade Method... 4-2 4.2 Software Upgrade ... 4-5 4.2.1 Installing Mindray Patient Monitor Software Upgrade Tool... 4-5 4.2.2 Software Upgrade Procedure ... 4-7 5 Testing and Maintenance... 5-1 5.1 Introduction... 5-1 5.1.1 Test Equipment... 5-1 5.1.2 Test Report ... 5-1 5.1.3 Preventative Maintenance ... 5-2 5.1.4 Recommended Frequency ... 5-2 5.2 Preventative Maintenance Procedures ... 5-3 1

5.2.1 Visual Inspection ... 5-3 5.2.2 NIBP Tests and Calibration ... 5-4 5.2.3 Sidestream and Microstream CO2 Module Tests... 5-7 5.2.4 Preventative maintenance test report... 5-9 5.3 Power On Test ... 5-10 5.4 Module Performance Tests... 5-10 5.4.1 ECG Tests and Calibration ... 5-10 5.4.2 Resp Performance Test...5-11 5.4.3 SpO2 Test... 5-12 5.4.4 NIBP Tests... 5-12 5.4.5 Temp Test ... 5-12 5.4.6 IBP Tests ... 5-13 5.4.7 C.O. Test... 5-15 5.4.8 Mainstream CO2 Tests... 5-15 5.4.9 Sidestream and Microstream CO2 Module Tests... 5-17 5.4.10 PiCCO Tests ... 5-17 5.5 Analog Output Performance Test ... 5-20 5.6 Electrical Safety Test... 5-20 5.7 Touchscreen Calibration... 5-21 5.8 Network Print Test ... 5-21 5.8.1 Equipment Connection and Setup ... 5-21 5.8.2 Print Function Test ... 5-22 5.9 Battery Check... 5-22 5.10 Factory Maintenance... 5-23 5.10.1 Accessing Factory Maintenance Menu ... 5-23 5.10.2 Drawing Waves ... 5-23 5.10.3 Software Version ... 5-23 5.10.4 Monitor Information... 5-25 5.10.5 Calibrate NIBP ... 5-25 6 Troubleshooting... 6-1 6.1 Introduction... 6-1 6.2 Part Replacement ... 6-1 6.3 Checking Patient Monitor Status... 6-1 6.4 Checking Software Version... 6-2 6.5 Checking Technical Alarms ... 6-3 6.6 Troubleshooting Guide... 6-3 6.6.1 Power On/Off Failure... 6-3 6.6.2 Display Failures ... 6-4 6.6.3 Alarm Problems... 6-4 6.6.4 Button Failures ... 6-5 6.6.5 External Parameter Module Failure ... 6-5 6.6.6 Input/Output Interface Failure...6-5 6.6.7 Storage Failure ... 6-6 6.6.8 Power Supply Failures ... 6-6 2

6.6.9 Wired Network Related Problems... 6-7 6.6.10 Wi-Fi Related Problems ... 6-7 6.6.11 Software Upgrade Problems... 6-8 7 Disassembly and Repair ... 7-1 7.1 Tools Required ... 7-1 7.2 Preparations for Disassembly... 7-1 7.3 Disassembly ... 7-2 7.3.1 Removing the Battery Door and Battery... 7-2 7.3.2 Disassembling the Rear Housing Assembly... 7-2 7.3.3 Disassembling the Front Housing Assembly... 7-6 8 Parts ... 8-1 8.1 Introduction... 8-1 8.2 Main Unit ... 8-2 8.2.1 Exploded View ... 8-2 8.2.2 Parts List ... 8-2 8.3 Front Cover Assembly ... 8-4 8.3.1 Exploded View ... 8-4 8.3.2 Parts List ... 8-4 8.4 Rear Cover Assembly... 8-6 8.4.1 Exploded View ... 8-6 8.4.2 Parts List ... 8-6 8.5 Main Frame Assembly ... 8-7 8.5.1 Exploded View ... 8-7 8.5.2 Parts List ... 8-7 8.6 Parameter Connector Assembly ... 8-8 8.6.1 Exploded View ... 8-8 8.6.2 Parts List ... 8-8 8.7 Parameter Assembly... 8-9 8.7.1 Exploded View ... 8-9 8.7.2 Parts List ... 8-9 8.8 Other Replaceable Parts ... 8-10 A Electrical Safety Inspection ...A-1

3

FOR YOUR NOTES

4

1 Safety 1.1 Safety Information DANGER z

Indicates an imminent hazard that, if not avoided, will result in death or serious injury.

WARNING z

Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.

CAUTION z

Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

NOTE z

Provides application tips or other useful information to ensure that you get the most from your product.

1.1.1 DANGER There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective sections of this manual.

1-1

1.1.2 Warnings

WARNING z

All installation operations, expansions, changes, modifications and repairs of this product are conducted by authorized personnel.

z

Disconnect the patient monitor from external power source and remove the battery before disassembling the equipment.

z

When you disassemble/reassemble a parameter module, a patient leakage current test must be performed before it is used again for monitoring.

z

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.

z

Dispose of the package material, observing the applicable waste control regulations and keeping it out of children’s reach.

1.1.3 Cautions CAUTION z

Make sure that no electromagnetic radiation interferes with the performance of the equipment when preparing to carry out performance tests. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

z

Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or in this manual.

z

Protect the equipment from damage caused by drop, impact, strong vibration or other mechanical force during servicing.

1.1.4 Notes NOTE z

Refer to Operation Manual for detailed operation and other information.

1-2

1.2 Equipment Symbols Attention: Consult accompanying documents (this manual).

Power ON/OFF (for a part of the equipment)

Battery indicator

External power supply

Multifunctional connector

External device connector

ESD warning symbol for Electrostatic sensitive devices.

Network connector

Manufacture date

Serial number

Type CF applied part. Defibrillator-proof protection against electric shock. Type BF applied part. Defibrillator-proof protection against electric shock. 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. European community representative

Dispose of in accordance to your country’s requirements

1-3

FOR YOUR NOTES

1-4

2 Theory of Operation 2.1 Introduction The BeneView T1 is intended to be used for monitoring, displaying, reviewing, storing and transferring of multiple physiological parameters including ECG, respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O./PiCCO), and carbon dioxide (CO2) of single patient.

2.1.1 Front View

1.

Alarm lamp The Alarm lamp flashes in different color and frequency to match the alarm level.

2.

Display Screen

3.

Ambient light sensor When [Brightness] is set to [Auto], the system automatically adjusts screen brightens according to the strength of ambient light.

4.

5.

External power supply indicator ‹

On: when external DC power supply is connected.

‹

Off: when external DC power supply is not connected.

Battery indicator ‹

On: when the battery is installed and the external DC power supply is connected. 2-1

6.

7

‹

Off: when no battery is installed, or the installed battery is malfunction, or no external DC power supply is connected when the patient monitor is power off.

‹

Flash: when the patient monitor operates on battery power.

Power On/Off Switch ‹

Pressing this switch turns the patient monitor on.

‹

When the monitor is on, pressing and holding this switch turns the monitor off.

An indicator is built in this switch. It turns on when the patient monitor is on and turns off when the patient monitor is off. Lock/unlock switch: Sliding this switch rightwards can lock/unlock the touch screen.

2.1.2 Left View

1.

Network Connector It is a standard RJ45 connector that connects the patient monitor to the CMS or CIS.

2.

External device connector: connects a USB drive.

3.

External DC power supply connector

4.

Infrared filter It is used for communication between T1 and Mindray BeneVeiw monitor.

5.

Contact

2-2

NOTE z

To ensure a good contact, clean the contacts regularly, as dust and dirt may collect on them. When cleaning the contacts, wipe them with cotton, dampened with alcohol. (using forceps is recommended)

2.1.3 Right View

1.

Connector for Temp probe 1

2.

Connector for Temp probe 2

3.

Connector for IBP cable

4.

Connector for NIBP cuff

5.

Connector for ECG cable

6.

Connector for SpO2 cable

7.

Multifunctional connector, connecting external parameter module and outputting analog out and defib synchronization signal.

8.

Speaker

2-3

2.1.4 Bottom View

1.

Latch: locks T1 when T1 is in use with a BeneView patient monitor or the monitor handle. Pressing here releases T1 so that you can take it out from the host monitor or the monitor handle.

2.

Battery door

2.2 System Structure ECG、SPO2、TEMP、NIBP、IBP accessories

DC adapter

Main unit

External parameter module

The equipment consists of the DC adapter, main unit, external parameter modules, and accessories. The DC adapter converts AC power into DC power, and the accessories convert the physiological signals collected from human body into electric signals. This chapter describes the structure of the main unit and external parameter modules.

2-4

2.2.1 Main Unit The following figure shows the main unit architecture of T1.

Valve assembly

Multi-parameter board

Backup battery pack

Infrared board

Parameter connector board

Pump Battery

SPO2

Extended connector

Speaker DC-IN PUSB RJ45

Main board

Antenna LCD and touchscreen

Wi-Fi

Note: In this figure, the black blocks are hard wired while the others are flexible wired.

2.2.1.1 Main Board The main board is the core of control over the entire system. It also implements DC/DC conversion and power management. The main functions of the main board are: 1.

Implementing display drive, audio drive, Wi-Fi drive, and touch screen drive;

2.

Implementing network communication, data storage, serial port extension, button scanning, and DC/DC conversion;

3.

Controlling power on/off, alarm indicating lamp, backlight, and fan;

4.

Managing multi-parameter subsystem, smart battery, external parameter modules;

5.

Detecting whether the battery is on position; 2-5

6.

Exchanging data with the infrared communication backboard;,

7.

Controlling the power supply to peripheral devices, such as screen backlight, digital drive of the screen, and Wi-Fi; turning off these devices individually or switching them into low power consumption mode.

2.2.1.2 Multi-parameter Board The multi-parameter board provides the following functions: 1.

ECG and Resp measurement;

2.

SpO2 measurement (by backboard, supporting Mindray SpO2, Masimo SpO2, and Nellcor SpO2 modules);

3.

NIBP measurement;

4.

2-channel TEMP measurement;

5.

2-channel IBP measurement;

6.

Isolating the parameter modules, except NIBP, from the earth;

7.

Isolating ECG from other parameters;

8.

Analog output (one channel for ECG and two channels for IBP);

9.

Defib sync output; and,

10. Data exchange with the main board through the serial ports.

2.2.1.3 Parameter Connector Board The parameter connector board provides the following functions: 1.

ECG signal isolation and transmission;

2.

SpO2 signal transmission;

3.

TEMP signal transmission;

4.

IBP signal transmission;

5.

Speaker transmission; and,

6.

Analog output transmission.

2.2.1.4 Infrared Communication Backboard The infrared communication backboard implements infrared communication and transmits signals between the multi-parameter board and the main board.

2-6

2.2.1.5 Wi-Fi Module The Wi-Fi module supports wireless network that is compatible with 802.11 b/g standard.

2.2.2 External Parameter Modules Module

Dock

Base adapter

Plug

The extended parameter module consists of a module and a dock. T1 has five kinds of external parameter modules. When connecting with the main unit, the external parameter module should be in use with the dock. The dock for the five different external parameter modules is the same.

2.2.2.1 Dock Adapter Together with the module adapter, the dock adapter implements electric connection between the dock and the module. The dock adapter provides the following functions: 1.

Converting 232 level to TTL level;

2.

Realizing module on-position detection. Power is output only when there is a module on the dock.

2.2.2.2 External Parameter Modules The equipment can be configured with the following external parameter modules: „

Sidestream CO2 module;

„

Microstream CO2 module;

„

Mainstream CO2 module;

„

C.O. module; and,

„

PiCCO module.

2-7

FOR YOUR NOTES

2-8

3 Unpacking and Installation This chapter provides information you need to install a patient monitor ready for use.

3.1 Unpacking the Equipment Open the package and take out the packing list. Check that all the articles included in the packing list are available and the quantity and specification are correct. „

All the optional parts purchased by the customer shall also be checked.

„

Notify the supplier if provided components are not correct as compared to the packing list.

„

In case of damage during transportation, keep the packing material and notify the supplier immediately.

„

Keep the packing material till the equipment is accepted.

3.2 Preparation for Installation 3.2.1 Preparation for Installation Site 1.

Ensure that the site meets all safety, environmental and power requirements

2.

Check that required power sockets are available.

3.

Check that a network connector is available if the monitor needs to be connected to the wired network.

WARNING z

Use only DC adapter provided with the system.

3-1