BeneHeart D3 and D2 Service Manual Ver 1.0 Sept 2017

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: 1.0



Release time:

September 2017

© 2017 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

Company Contact Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

E-mail Address:

[email protected]

Tel:

+86 755 26582479, +86 755 26582888

Fax:

+86 755 26582934, +86 755 26582500

I

Preface Manual Purpose This manual provides detailed information about the assembling, dissembling, testing and troubleshooting of the equipment to support effective troubleshooting and repair. It is not intended to be a comprehensive, in-depth explanation of the product architecture or technical implementation. Observance of the manual is a prerequisite for proper equipment maintenance and prevents equipment damage and personnel injury.

Intended Audience This manual is for biomedical engineers, authorized technicians or service representatives responsible for troubleshooting, repairing and maintaining the defibrillator/ monitors

Passwords Passwords may be required to access different modes. The passwords are listed below:



Installation mode:

888888



Service mode:

332888



Configuration mode:

315666

II

Contents 1 Safety ... 1-1 1.1 Safety Information ... 1-1 1.1.1 Dangers ... 1-2 1.1.2 Warnings ... 1-2 1.1.3 Cautions ... 1-3 1.1.4 Notes ... 1-4 1.2 Equipment Symbols ... 1-4

2 Theory of Operation ... 2-1 2.1 The Basics ... 2-1 2.1.1 Overview ... 2-1 2.1.2 Main Functions ... 2-1 2.2 Components ... 2-2 2.3 Main Unit ... 2-2 2.3.1 System Structure ... 2-3 2.3.2 System Signal Flow ... 2-4 2.3.3 Signal Sequence of Power-On/Off ... 2-5 2.4 Front Housing Assembly ... 2-5 2.5 Paddle Tray ... 2-6 2.6 Rear Housing Assembly ... 2-6 2.6.1 Power System ... 2-6 2.6.2 Main Control System ... 2-7 2.6.3 Therapy System ... 2-8 2.6.4 Recorder... 2-8 2.6.5 Parameter Measurement System ... 2-9 2.7 External Device Connectors ... 2-9

3 Unpacking and Installation ... 3-1 3.1 Unpacking the Equipment ... 3-1 3.2 Preparation for Installation ... 3-2 3.2.1 Preparation for Installation Site... 3-2 3.2.2 Electrical Requirements ... 3-3 3.3 Preparation for Power On... 3-3 3.4 User Test... 3-3

4 Testing and Maintenance ... 4-1 4.1 Introduction ... 4-1 4.1.1 Test Report ... 4-1 4.1.2 Recommended Frequency ... 4-1 4.2 Visual Test ... 4-2

1

4.3 Power On Test ... 4-2 4.4 User Test... 4-3 4.5 Password for Installation Mode... 4-4 4.6 Module Performance Tests ... 4-4 4.6.1 Manual Defibrillation Test ... 4-4 4.6.2 Pacing Test ... 4-6 4.6.3 ECG Test... 4-6 4.6.4 Resp Test ... 4-7 4.6.5 SpO2 Test ... 4-8 4.6.6 NIBP Tests ... 4-8 4.6.7 CO2 Module Tests ... 4-11 4.7 Electrical Safety Tests ... 4-12 4.8 Recorder Check ... 4-12 4.9 Factory Service ... 4-12 4.9.1 Password for Service Mode... 4-12 4.9.2 Accessing Service Mode Menu... 4-12 4.9.3 Calibrating/Zeroing Impedance ... 4-13 4.9.4 Device Information ... 4-14 4.9.5 Checking Failure Code ... 4-14 4.9.6 Inputting Serial Number ... 4-15 4.9.7 Paddle Open Circuit Display ... 4-15

5 Hardware and Software Upgrade ... 5-1 5.1 Hardware Upgrade ... 5-1 5.1.1 Upgrade MPM module ... 5-1 5.1.2 Upgrade the Therapy Module... 5-2 5.2 Software Upgrade through a PC ... 5-3 5.2.1 Installing Mindray Patient Monitor Software Upgrade Tool ... 5-4 5.2.2 Software Upgrade Procedure ... 5-6

6 Troubleshooting ... 6-1 6.1 Overview ... 6-1 6.2 Part Replacement ... 6-1 6.3 Checking Defibrillator/Monitor Status ... 6-1 6.4 Checking Device Information ... 6-2 6.5 Checking Technical Alarm ... 6-2 6.6 Troubleshooting Guide ... 6-2 6.6.1 Defibrillation Problems ... 6-2 6.6.2 Pacing Problems ... 6-4 6.6.3 Power On/Off Problems ... 6-4 6.6.4 Display Problems ... 6-5 6.6.5 Alarm Problems... 6-6 6.6.6 Button and Knob Problems ... 6-6 6.6.7 Recorder Problems... 6-7

2

6.6.8 Output Interface Problems ... 6-8 6.6.9 Memory Card Problems ... 6-8 6.6.10 Power Supply Problems... 6-8 6.6.11 Software Upgrade Problems... 6-9 6.7 Technical Alarm Messages ... 6-10 6.8 Error Codes ... 6-15 6.8.1 Therapy Module Error Codes... 6-15 6.8.2 Power Module Error Codes ... 6-17 6.8.3 Main Control Error Codes ... 6-18 6.8.4 M51C Error Codes ... 6-19

7 Disassembly and Repair ... 7-1 7.1 Tools Required ... 7-1 7.2 Preparations for Disassembly ... 7-1 7.3 Disassembling the Main Unit... 7-2 7.3.1 Removing Hook Mount (if configured) ... 7-3 7.3.2 Removing Paddle Tray ... 7-3 7.3.3 Separating the Housing ... 7-5 7.3.4 Discharging the Capacitor ... 7-6 7.3.5 Disassembling the MPM Module Assembly ... 7-6 7.3.6 Removing the Parameter Panel Assembly ... 7-7 7.3.7 Removing the Therapy Module... 7-7 7.3.8 Disassembling the Power Base Assembly ... 7-8 7.3.9 Disassembling the AC/DC Power Supply Board... 7-9 7.3.10 Disconnecting the Therapy Port Cable ... 7-10 7.3.11 Removing the Main Board Assembly ... 7-11 7.3.12 Checking Waterproof Strips before Reassembling ... 7-12 7.4 Disassembling the Front Housing Assembly ... 7-14 7.4.1 Removing the Keypad Board ... 7-14 7.4.2 Removing Display Assembly ... 7-15 7.4.3 Removing the Alarm Lamp Board and Assistant Keypad Board ... 7-16 7.4.4 Removing the Speaker ... 7-17 7.4.5 Removing the Mode Select Knob ... 7-17 7.4.6 Removing the Encoder ... 7-18 7.4.7 Checking Waterproof Material on the Front Housing ... 7-18 7.5 Removing the Recorder ... 7-19 7.6 Disassembling the Recorder ... 7-19

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 Housing Assembly ... 8-3

3

8.3.1 Exploded View ... 8-3 8.3.2 Parts List ... 8-3 8.4 Rear Housing Assembly ... 8-6 8.4.1 Exploded View ... 8-6 8.4.2 Parts List ... 8-7 8.5 Therapy Board Subassembly ... 8-8 8.5.1 Exploded View ... 8-8 8.5.2 Parts List ... 8-9 8.6 MPM Assembly ... 8-10 8.6.1 Exploded View ... 8-10 8.6.2 Parts List ... 8-11 8.7 Power Base Assembly（115-007253-00） ... 8-12 8.7.1 Exploded View ... 8-12 8.7.2 Parts List ... 8-13 8.8 Paddle Tray Assembly ... 8-14 8.8.1 Exploded View ... 8-14 8.8.2 Parts List ... 8-15

A Electrical Safety Inspection... A-1

4

1 Safety 1.1 Safety Information

DANGER 

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

WARNING 

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

CAUTION 

Indicates a potential hazard or unsafe maintenance 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 can better service your product.

1-1

1.1.1 Dangers

DANGER 

The equipment delivers up to 360 J of electrical energy. Unless properly used as described in these Operating Instructions, this electrical energy may cause serious injury or death. Do not attempt to operate this defibrillator unless thoroughly familiar with these operating instructions and the function of all controls, indicators, connectors, and accessories.



Defibrillation current can cause operator or bystander severe injury or even death. Keep distance with the patient or metal devices connected to the patient during defibrillation.



Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high voltages may be present. Contact authorized service personnel for repair.



To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents (such as gasoline). Keep the equipment and the operating environment dry and clean.

1.1.2 Warnings

WARNING 

Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition.



Make sure the synchronous input system is applied to this equipment and the input signal is correct if necessary.



To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. If the installation does not provide for a protective earth conductor, disconnect it from the power line and operate it on smart lithium-ion batteries.



Ensure that the equipment is supplied with continuous electric power during work. Sudden power failure leads to the loss of patient data.



Use and store the equipment in specified environmental condition. The equipment and accessesories may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range.



This equipment is used for single patient at a time.



Medical electrical equipment which does not incorporate defibrillator protection should be disconnected during defibrillation.



Do not defibrillate a patient who lies on the wet ground.



Do not touch the patient and live parts simultaneously.



Do not touch the patient when connecting the peripheral equipment via the I/O signal ports to prevent patient leakage current from exceeding the requirements specified by the standard.

1-2



Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off may result in a hazard to the patient. Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring.



Do not perform any functional check if the equipment is connected with a patient; otherwise the patient might be shocked.



Remain attentive to the patient during applying therapy. Delay in delivering a shock may result in a rhythm that was analyzed as shockable converting spontaneously to non-shockable and could result in inappropriate delivery of a shock.



For the treatment of patients with implantable pacemakers, place therapy pads or paddles away from internal pacemaker generator if possible to help prevent damage to the pacemaker.



To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement or strangulation by patients or personnel.



Do not touch device connectors, recorder print head, battery connector or other live equipment if in contact with the patient; otherwise patient injury may result.



To ensure patient safety, use only parts and accessories specified in this manual.



Package material may contaminate the environment. Properly dispose of the package material according to applicable waste control regulations and keep it out of children’s reach.

1.1.3 Cautions

CAUTION 

Use of Manual Therapy security password requires the clinician to know and remember the password. Failure to enter correct password will prevent the delivery of manual defibrillation, synchronized cardioversion and pacing therapy.



At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products to avoid contaminating the environment.



Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phones, 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.



Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.

1-3



Dry the equipment immediately in case of rain.



Never charge and deliver shock frequently in non-clinical situations. Otherwise equipment damage could occur.

1.1.4 Notes NOTE 

The equipment use a mains plug as isolation means to the mains power supply. Do not locate the equipment in a place difficult to operate the mains plug.



During normal use, the operator shall stand in front of the equipment.



Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.



If the equipment is run on a DC power supply, a DC/AC adapter we supply should be used.



This manual describes all features and options. Your equipment may not have all of them.

1.2 Equipment Symbols See the BeneHeart D3/ BeneHeart D2 Defibrillator/Monitor Operator’s Manual (P/N: 046-010599-00) for information about the symbols used on this product and its packaging.

1-4

2 Theory of Operation 2.1 The Basics 2.1.1 Overview The BeneHeart D3/BeneHeart D2 defibrillator/monitor (hereinafter called the equipment) provides four operating modes: Manual Defib, AED, Pacer, and Monitor. The equipment is for use in hospital and pre-hospital settings. It adopts the most advanced biphasic defibrillation technology and can deliver up to 360J of defibrillation energy.

The equipment has an 7.0 inch color TFT LCD display with LED Backlight.

2.1.2 Main Functions The equipment has the following main functions:



Manual Defib Mode

In Manual Defib Mode, the operator analyzes the patient’s ECG, and, if appropriate, follows this procedure: 1

Select the Manual Defib mode, adjust the energy level if necessary

2

Charge; and

3

Deliver the shock.

Defibrillation may be performed through external paddles or multifunction electrode pads. In Manual Defib Mode, you can also perform synchronized cardioversion.



AED Mode

In AED mode, the equipment automatically analyzes the patient’s ECG rhythm and indicates whether or not a shockable rhythm is detected. Voice prompts provide easy-to-follow instructions and patient information to guide you through the defibrillation process. Messages and flashing buttons are also presented to reinforce the voice prompts.



Pacer Mode

The Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through multifunction electrode pads using a monophasic square waveform.



Monitor Mode

In Monitor Mode, the equipment is intended for monitoring, displaying, reviewing, storing and printing multiple physiological parameters and waveforms including ECG and pulse oximetry (SpO2),

2-1

2.2 Components The equipment consists of a main unit, accessories and PC software.

The main unit is the core of the equipment. It provides: 

Overall system control;



System power supply;



Display;



Defibrillation and pacing;



AED ;



Man-mahcine interface;



Audible and visible alarms;



Multiple parameter measurements;



External connectors and communication; and



Recording, printing and data storage.

2.3 Main Unit The main unit is composed of the front housing assembly, rear housing assembly and the paddle tray assembly. External paddles are rested in the paddle tray. 

The front housing assembly mainly consists of LCD, keypad board, speaker, microphone, Mode Select knob, navigation knob, alarm lamp board, front housing and front housing sheet metal, etc.



The rear housing assembly consists of CPU board, therapy module, high voltage capacitors, MPM module, power management board, fan, measurement module panel, therapy port, recorder and rear housing, etc.



The paddle tray is for holding the external paddles.

2-2

Rear housing assembly Front housing assembly

2.3.1 System Structure

2-3

2.3.2 System Signal Flow The system uses the CPU and power management board as the core. The CPU and power management board is divided into the power management part and the main control part. The processor of the power management part is MSP430, which mainly implements communication with external lithium batteries and power management. The processor of the main control part is AM3352, which communicates with and controls other subsystem modules (including the therapy module, M51C module, M02D module, recorder module, CPR sensor, and keypad board on the front housing). The main control module communicates with other subsystems through asynchronous serial ports. The keypad board on the front housing implements the transit between man-machine interaction interfaces and signal display. The processor is M0, which controls input and output signals of keys, knobs, module switches, and alarm lamps.

Therapy module

GPIO

CPR sensor CPU and power management board RS232+ Power +GPIO

Main control

Power management

URAT+Power GPIO

MSP430

AM3352

UART

SmBUS+ GPIO+ Power

Power UART+ GPIO +Power

M51C Module

LVDS+Power+GPIO

Lithium batteries

ACDC module

Navigation knob Mode switch

UART+ Power

Keypad board

Alarm lamp

GPIO+Power

Recorder module

UART+ GPIO +Power

LVDS + Power

M0

GPIO+ Power

M02D module

GPIO+ Power

Speaker

Microphone

2-4

LCD

2.3.3 Signal Sequence of Power-On/Off The power-on/off action is triggered by the naviagation knbo on the keypad board of the front housing. The power-on/off process is controlled by the power management processor as follows:

CPU and power management board

TPS2490 EXTLD

Dual-line DC/DC

Single-line DC/DC VCC_EN

Keypad board

PCON

ENABLE

MCU

RUN

Power-on process: When you rotate the mode switch on the front panel of the defibrillator/monitor to a mode other than "Off", the PCON signal value is changed from 1 to 0 to awake the MCU. The MCU immediately outputs the ENABLE control signal to the TPS2490 enabling the VBUS. Then, the MCU enables the RUN signal control of the dual-line DC-DC module to output 5 V (VBB) and 12 V signals.

Power-off process: When your rotate the mode switch to "Off", the PCON signal value is changed from 0 to 1, and the MCU outputs the ENABLE=0 and RUN=0 signals to shut down the VBUS and the DC-DC module.

2.4 Front Housing Assembly The front housing assembly consists of display assembly, a keypad board, a speaker, a microphone, a Mode Select knob, a navigation knob, an alarm lamp board, a front housing and front housing sheet metal, etc.

Navigation Knob You can rotate the knob clockwise or counterclockwise and then press it to confirm a selection. The knob is connected to the keypad board.

Mode Select Knob A 8-position encoder is used to select the operating mode (Monitor, Manual Defib, AED and Pacer) and power-off. The unused positions are mechanically disabled.

Speaker The speaker emits alarm tones, key-stroke tone, heart beats and PR sound. It supports the functions of PITCH TONE and the multi-level volume. The speaker is connected to the keypad board. 2-5

Microphone It provides the function of voice recording.

Alarm Lamp Board The keypad board interfaces with the alarm lamp board. The alarm lamp transmits signals to drive the green and yellow alarm lamp. The drvie current 60mA.

2.5 Paddle Tray The paddle tray is used to hold paddles. It has a 50 ohm test load and position detective switch inside. When the equipment runs self tests, test current will pass through the test load.

2.6 Rear Housing Assembly The rear housing assembly consists of the CPU and power management board, therapy module, high voltage capacitors, M51C module, recorder, rear housing, parameter receptacle panel, and therapy port.

2.6.1 Power System

2-6



AC/DC board

It has AC mains as an input and outputs 18VDC. 

Battery

Its rated voltage is 14.8V, 3000mAh. Or, its rated voltage is 15.1V, 5600mAh. 

CPU and power management board

It manages the system power input, supplies different system power, and monitors the power status. The power management part implements battery charging and status information management.

The priority of system power supply is AC mains, Battery. That is to say, when AC is not available, Battery is used.

2.6.2 Main Control System Serving as the core of the system, the main control system implements the display, storage, printing, and review of parameters and waveforms, as well as parameter algorithm processing.

The integrated CPU and power management board consists of the MSP430 for power management and the AM3352 for main control. The MSP430 monitors the power status and controls the power-on/off; the AM3352 implements man-machine interaction, screen display, and AED algorithm. The main control module part and the power management part communicate with each other through asynchronous serial ports.

2-7

2.6.3 Therapy System The therapy system implements the measurement of P-lead input ECG and human body impedance, as well as the defibrillation and pacing functions. The pacing function is implemented by the optional pacing module.

2.6.4 Recorder The recorder implements the parameter and waveform printing function by using the universal TR6F recorder module.

The recorder receives data from the CPU board and then sends the data to a thermal head for printing. The recorder front panel has a key for starting/ stopping the recorder and a green indicator which is lit when working normally. The recorder is connected to the keypad board which board provides connection for the TR6F recorder. The block diagram and functional modules of the recorder are shown as below.

2-8

Module

Description

Power Interface

Adjusts input voltage to run each module.

Recorder CPU

Coordinates module communication, controls and processes module status.

Keypad board Interface

Serves as the data communication channel between the keypad board and the recorder CPU.

Motor Drive Circuit

Receives control signals sent by the recorder CPU to drive the step motor.

Keypad and Indicator

Sends keypad commands to CPU and receives CPU commands to control the

Interface

indicator.

FPC Interface

Sends print head information to CPU and receives CPU commands to control the print head.

2.6.5 Parameter Measurement System The M51C multi-parameter module implements the parameter measurement function. It mainly implements 3/5-lead ECG, SpO2, NIBP, and RESP measurement functions.

2.7 External Device Connectors

1

5 6 2 7

3

4

2-9