D1 Service Manual Ver 5.0

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: 5.0

◼

Release time:

September 2023

© 2013-2023 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 81888998

Fax:

+86 755 26582680

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 equipment.

Password The default password to access the configuration edit mode is 3156.

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 ... 1-3 1.2 Equipment Symbols... 1-3 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 Front Housing Assembly ... 2-4 2.3.2 Module Bracket Assembly ... 2-4 2.3.3 Rear Housing Assembly ... 2-5 2.4 Batteries ... 2-5 2.5 External Device Connectors ... 2-6 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 Environmental Requirements ... 3-2 3.3 Power On the Equipment ... 3-3 4 Software Upgrade ... 4-1 4.1 Upgrade Procedures ... 4-1 4.2 Precautions ... 4-2 5 Testing and Maintenance ... 5-1 5.1 Introduction ... 5-1 5.1.1 Test Report... 5-1 5.1.2 Recommended Frequency ... 5-1 5.2 Visual Inspection ... 5-2 5.3 Power On Test ... 5-2 5.4 User Test ... 5-2 5.5 Module Performance Tests ... 5-3 5.5.1 AED Test ... 5-3 5.5.2 Manual Defibrillation Test ... 5-3 5.5.3 ECG Test ... 5-6 1

5.6 Electrical Safety Tests ... 5-6 5.6.1 Device Enclosure and Accessories... 5-7 5.6.2 Device Labelling ... 5-7 5.6.3 Patient Leakage Current ... 5-7 5.6.4 Mains on Applied Part Leakage ... 5-9 5.6.5 Patient Auxiliary Current ...5-12 5.6.6 Scheduled Electrical Safety Inspection ...5-13 5.6.7 Electrical Safety Inspection after Repair...5-14 6 Troubleshooting ... 6-1 6.1 Overview ... 6-1 6.2 Parts Replacement ... 6-1 6.3 Checking Equipment Status... 6-1 6.4 Checking Technical Alarm ... 6-1 6.5 Troubleshooting Guide ... 6-2 6.5.1 Defibrillation Problems ... 6-2 6.5.2 Power On/Off Problems ... 6-2 6.5.3 Display Problems ... 6-3 6.5.4 Alarm Problems... 6-3 6.5.5 Button Problems ... 6-3 6.5.6 Output Interface Problems ... 6-4 6.5.7 Power Supply Problems ... 6-4 6.5.8 Software Upgrade Problems... 6-4 6.6 Technical Alarm Messages ... 6-5 6.7 Error Codes ... 6-6 6.7.1 Therapy Module Error Codes ... 6-6 6.7.2 Power Module Error Codes ... 6-8 6.7.3 Main Control System Error Codes ...6-11 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 Remove the Rear Housing ... 7-2 7.3.2 Discharge Using the Discharge Fixture ... 7-3 7.3.3 Remove the Parameter Connector, Therapy Connector Cable and Speaker ... 7-4 7.3.4 Remove the Module Bracket ... 7-5 7.3.5 Remove the Therapy Port, Capacitor, Resistor, Inductor and Power On/Off Light Board ... 7-6 7.3.6 Remove the Therapy Main Control Board ... 7-8 7.3.7 Remove the LCD Display and Keypad Board ... 7-9 7.3.8 Check before Re-assembling ... 7-9 8 Parts ... 8-1 8.1 Introduction ... 8-1 8.2 Main Unit ... 8-1 8.2.1 Exploded View ... 8-1 2

8.2.2 Parts List... 8-2 8.3 Front Housing Assembly ... 8-3 8.3.1 Exploded View ... 8-3 8.3.2 Parts List... 8-3 8.4 Battery Door Assembly ... 8-4 8.4.1 Exploded View ... 8-4 8.4.2 Parts List... 8-4 8.5 Battery Door Assembly ... 8-6 8.5.1 Exploded View ... 8-6 8.5.2 Parts List... 8-6

3

FOR YOUR NOTES

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.

⚫

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.

⚫

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.

1.1.2 Warnings

WARNING ⚫

Check for mechanical damages before each use. If case of any damage, do not apply it to patients.

⚫

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.

⚫

Run the equipment only on the supplied disposable or rechargeable battery.

⚫

Charge the rechargeable battery only with the supplied BatteryFeed 20 charger station.

⚫

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 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. 1-2

⚫

For the treatment of patients with implantable pacemakers, place therapy pads 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.

⚫

Keep a distance of at least 20cm away from the monitor when Wi-Fi function is in use.

1.1.3 Cautions

CAUTION ⚫

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.

⚫

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

⚫

Dry the equipment immediately in case of rain.

1.1.4 Notes

NOTE ⚫

Refer to Operator’s Manual for detailed operation and other information of the defibrillator/monitor.

1.2 Equipment Symbols See the BeneHeart D1 Automated External Defibrillator Operator’s Manual (P/N: 046-004673-00) for information about the symbols used on this product and its packaging. 1-3

FOR YOUR NOTES

1-4

2 Theory of Operation 2.1 The Basics 2.1.1 Overview There are two configurations for BeneHeart D1 (hereinafter called the equipment): Pro and Public. Pro provides manual defibrillation, AED, and 3-lead ECG monitoring functions while Public provides only AED working mode. It is intended for use in hospital and pre-hospital settings. The equipment adopts the most advanced biphasic defibrillation technology and can deliver up to 360J of defibrillation energy. The whole equipment is of horizontal structure and is configured with 7-inch color LCD display with LED backlight.

2.1.2 Main Functions Below is a brief introduction of the main functions: ◼

Manual defibrillation The manual defibrillation mode supports manual defibrillation and synchronized cardioversion functions. External multi-functional electrode pads are used when performing defibrillation. In manual defibrillation mode, the operator analyzes the patient’s ECG waveforms and does the following if necessary:

◼

1.

Select energy,

2.

Charge,

3.

Deliver shock.

AED 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.

◼

3-lead ECG monitoring In monitor mode, the equipment performs 3-lead ECG monitoring. The monitored information can be displayed, reviewed and stored.

2-1

2.2 Components The equipment consists of a main unit, accessories and PC software. The main unit is the core of the system and implements the following functions: ◼

Overall system control;

◼

System power supply and power management;

◼

Display;

◼

Manual defibrillation;

◼

AED;

◼

Man-machine interface;

◼

Audio and visual alarm indications;

◼

3-lead ECG monitoring;

◼

External connectors and communication; and,

◼

Data storage.

2.3 Main Unit The main unit of the equipment is composed of the front housing assembly, module bracket assembly and rear housing assembly. ◼

The front housing assembly is mainly composed of LCD display, power on/off key, discharge key, screen softkeys, microphone, buzzer, front housing etc.

◼

The module bracket assembly is mainly composed of module bracket, speaker, ECG parameter socket, defibrillation capacitor, discharge inductor, discharge resistor, therapy main control board, defibrillation output port, Wi-Fi module etc.

◼

The rear housing assembly is cmposed of rear housing and battery door etc.

The whole system is composed of the following subsystems: ◼

Input subsystem, including the power on/off key, discharge key, screen softkeys and microphone.

◼

Output subsystem, including the display, buzzer and speaker.

◼

Processing and communication subsyste, including main control module, therapy module, parameter module and power management module.

◼

Power management subsystem, including the batteries and power management module.

◼

External device connection subsystem, including the USB connector and wireless network connection.

2-2

System Structure

Power on/off key

W11

LCD display and backlight

W6

1 wire type

W5

Therapy connector

W9

Hollow inductor

W10

High voltage capacitor

W12

Defibrillation resistor

W2

Therapy main control board Speaker

W3

W4 W8

battery

ECG connector USB

W12

Electrode pad

Socket connector

Connection cable

System Signal Flow

Battery SMBUS/HDQ Power management module

UART Main control module

Therapy module

UART KEY SPI

Electrode pad

3-Lead ECG module

2-3

LCD

2.3.1 Front Housing Assembly The front housing assembly is mainly composed of LCD display, power on/off key, discharge key, screen softkeys, microphone, buzzer, front housing etc. The LCD display and screen softkeys are separately connected to the therapy main control board via cables. The power on/off keypad board is connected to the therapy main control board via internal connection line inside the equipment. Other components are directly placed on the therapy main control board.

Power on/off key The power on/off key provides power on/off function and is connected to the therapy main control board.

Discharge key The discharge key is a discharge trigger button and is placed on the therapy main control board.

Screen softkeys The screen softkeys provide the selection of functions displayed on the screen and is connected to the therapy main control board.

Buzzer The buzzer provides alarm tone.

Microphone The microphone provides sound recording function.

2.3.2 Module Bracket Assembly The module bracket assembly is mainly composed of module bracket, speaker, 3-lead ECG parameter measurement module, defibrillation capacitor, discharge inductor, discharge resistor, therapy main control board, defibrillation output port, Wi-Fi module etc.

Speaker The speaker provides main unit alarm tone, heart beat tone, and voice output.

2-4

3-lead ECG parameter measurement module The 3-lead ECG parameter measurement module provides 3-lead ECG monitoring and supports arrhythmia analysis and synchronized defibrillation R wave output. The 3-lead ECG parameter measurement module communicates with the therapy module via SPI port.

Therapy main control board The therapy main control board performs the functions of therapy, 3-lead ECG monitoring and input and output ports control etc. In terms of functions, the therapy main control board includes power management part, therapy module part and main control part. The main control part performs the functions of system man-machine interface control, data storage and network communication etc. The therapy part performs the functions of ECG and impedance signals sampling and processing, defibrillation charging/discharging, and AED algorithm analysis etc. The power management part performs the functions of system battery management, power monitoring etc. The whole equipment works with main control as the core. The main control part, therapy part and power management part communicate via asynchronous serial port.

Wi-Fi module The Wi-Fi module provides the wireless communication inlet for the main unit.

2.3.3 Rear Housing Assembly The rear housing assembly is composed of rear housing and battery door.

2.4 Batteries Battery provides power for the system. The equipment supports intelligent rechargeable lithium batteries and disposable lithium manganese batteries. ◼

Intelligent rechargeable lithium batteries: rated voltage of 14.8V, 3000 mAh.

◼

Disposable lithium manganese batteries: rated voltage of 12V, 4200 mAh.

2-5

2.5 External Device Connectors 1 4

5 6

2 3

1.

Electrode pad connector

2.

USB connector

3.

Battery compartment

4.

Handle

5.

CPR sensor

6.

ECG socket (for Pro only)

2-6

3 Unpacking and Installation This chapter provides information you need to install the equipment 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 new equipment is accepted.

The following pictures show the defibrillator/monitor and accessory packing.

Operator’s Manual

Accessories

Main unit and battery

3-1

3.2 Preparation for Installation 3.2.1 Preparation for Installation Site 1.

Ensure that the site meets all safety and environmental requirements.

2.

Ensure that the battery capacity is sufficient.

3.

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

WARNING ⚫

Only specified battery can be used.

3.2.2 Environmental Requirements

WARNING ⚫

To avoid explosion hazard, do not use the equipment in the presence of flammable anaesthetics, vapours or liquids.

CAUTION ⚫

The environment where the defibrillator/monitor will be used should be reasonably free from vibration, dust and corrosive substances. If these conditions are not met, the accuracy of the system may be affected and damage may occur.

Environmental Specification Main unit Item

Temperature

Relative humidity

Barometric pressure

Operating

0ºC to 50ºC (Room temperature - work for at

0% to 95%, non-condensing

57.0kPa to 106.2kPa

0% to 95%, non-condensing

57.0kPa to 106.2kPa

least 60 min after the temperature reaches 20 ºC) Storage

-30ºC to 70ºC

Charger station Item

Temperature

Relative humidity

Barometric pressure

Operating

0 ºC to 45ºC

10% to 95%, non-condensing

57.0kPa to 106.2kPa

Storage

-30ºC to 70ºC

10% to 95%, non-condensing

57.0kPa to 106.2kPa

3-2

3.3 Power On the Equipment CAUTION ⚫

Make sure that the battery capacity is sufficient and that the battery is correctly installed before powering on the defibrillator/monitor.

A user test shall be performed after the defibrillator/monitor is installed. Follow this procedure: 1.

Press the Power On/Off button. Select

softkey from the pop-up menu to enter maintenance screen.

2.

Select [User Test] on the maintenance screen.

3.

Push the corresponding softkey or select the corresponding button following the on-screen instructions.

4.

After the system displays prompt message and broadcasts audio message, select whether to hear the audio message based on the actual situation.

After completing these operations, the system automatically completes the other test items. If all test items are normal, the test result is “PASS”. If there is any failed item, the test result of battery insertion is “FAIL”. The system gives relevant prompt and failure code based on the failed item.

3-3