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Shenzhen Mindray Bio-Medical Electronics BeneHeart D6 User Manual

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BeneHeart D6/BeneHeart D5
Defibrillator/Monitor
Operator’s Manual

Table of Contents

Questions and Answers:

Shenzhen Mindray Bio-Medical Electronics BeneHeart D6 Specifications

General IconGeneral
BrandShenzhen Mindray Bio-Medical Electronics
ModelBeneHeart D6
CategoryMedical Equipment
LanguageEnglish

Summary

Intellectual Property Statement

Responsibility on the Manufacturer Party

Warranty

Exemptions

Details specific conditions and circumstances not covered by the warranty.

Company Contact

Preface

Manual Purpose

Explains the manual's role in safe operation and product performance.

Intended Audience

Identifies the target users of the manual, typically clinical professionals.

Illustrations

Notes that illustrations are examples and may not reflect exact setup.

Conventions

Defines symbols and text formatting used throughout the manual.

Safety Information

Dangers

Highlights imminent hazards that could result in death or serious injury.

Warnings

Identifies potential hazards or unsafe practices leading to death or serious injury.

Cautions

Points out potential hazards or unsafe practices causing minor injury or damage.

Notes

Provides application tips and useful information for optimal product use.

Equipment Symbols

The Basics

Equipment Introduction

Provides an overview of the device's features and operating modes.

Intended Use

Defines the intended applications and user qualifications for the equipment.

Applied Parts

Lists and describes the components that come into contact with the patient.

Main Unit

Details the physical components and views of the main device unit.

External Paddles

Describes the sternum and apex paddles used for therapy delivery.

Display Views

Illustrates and explains the different screen layouts in various operating modes.

Basic Operations and Settings

Equipment Installation

Provides essential guidelines for safely installing the equipment.

Basic Operation

Covers fundamental steps for operating the equipment, including power and connection.

Changing General Settings

Explains how to adjust system-wide settings like date, time, and display.

Analog Output

Details the ECG analog output capability via a multifunction connector.

Alarms

Alarm Categories

Classifies alarms into physiological, technical, and prompt message types.

Alarm Levels

Defines the severity levels for physiological and technical alarms.

Alarm Indicators

Describes visual and audible cues used to signal alarm conditions.

Alarm Tone Configuration

Details settings for alarm volume, reminder tones, and intervals.

Understanding the Alarm Setup Menu

Explains how to configure alarm properties and adjust limits.

Pausing Alarms

Describes how to temporarily silence or disable alarm indicators.

Switching Alarms Off

Explains conditions under which alarms are automatically switched off.

Switching Off Alarm Sounds

Details how to disable audible alarm tones and the conditions for exiting this state.

Resetting Alarms

Explains how to reset active alarms and restore normal alarm response.

Latching Alarms

Defines how alarm indicators behave after the alarm condition ends.

Clearing Technical Alarms

Describes how technical alarms are cleared or changed to prompt messages.

Testing Alarms

Provides methods to verify the correct functioning of alarm indicators.

Actions When an Alarm Occurs

Outlines the steps to take when an alarm condition is detected.

Monitoring ECG

ECG Introduction

Explains the ECG function, its display, and patient types supported.

ECG Safety Information

Highlights critical safety precautions for ECG monitoring.

Monitoring View

Describes the typical screen layout and displayed information in Monitor mode.

Preparing for ECG Monitoring and Measurement

Details the necessary steps for patient skin preparation and electrode application.

ECG Measurement with Electrode Pads

Explains the procedure for taking ECG measurements using electrode pads.

ECG Measurement with External Paddles

Details the process for ECG measurement using external paddles.

Checking Paced Status

Emphasizes the importance of correctly setting the patient's paced status.

ECG Display

Illustrates the ECG monitoring view and its components.

Changing ECG Settings

Covers adjustments for lead type, standard, waveform display, and filters.

Arrhythmia Analysis

Explains the function for analyzing patient heart rhythms and detecting events.

Calibrating ECG

Describes the procedure for calibrating ECG to ensure accurate amplitude.

ECG Troubleshooting

Provides solutions for common problems encountered during ECG monitoring.

Resting 12-Lead ECG Analysis

Resting 12-Lead ECG Analysis Introduction

Introduces the Glasgow algorithm for 12-lead ECG analysis.

Placing 10-leadwire Electrodes

Details the correct placement of electrodes for 12-lead ECG acquisition.

Entering the 12-lead ECG Screen

Explains how to access the dedicated 12-lead ECG display.

Changing 12-Lead ECG Analysis Settings

Covers adjustments for patient information, filters, and thresholds.

Initiating Resting 12-lead ECG Analysis

Describes the steps to start and perform the 12-lead ECG analysis.

Reviewing the12-Lead ECG Report

Explains how to access and view stored 12-lead ECG reports.

Recording the 12-Lead ECG Report

Details how to record and print realtime or stored 12-lead ECG reports.

Transmitting the 12-Lead ECG Report

Explains how to send 12-lead ECG reports via network connections.

Exiting the 12-lead ECG Screen

Describes how to exit the 12-lead ECG interface.

AED

AED Introduction

Provides an overview of the Automated External Defibrillator (AED) mode.

AED Safety Information

Highlights critical safety precautions specific to AED operation.

AED View

Illustrates the typical screen display during AED mode operation.

AED Procedure

Details the step-by-step process for using the AED function.

Shock Advised

Describes the condition and prompts when a shockable rhythm is detected.

No Shock Advised (NSA)

Explains prompts and actions when no shockable rhythm is detected.

CPR

Covers CPR-related functions within the AED mode, including time settings.

AED Sound Recording

Explains how to enable and use the voice recording feature.

AED Setup

Guides users on configuring various settings for the AED mode.

Manual Defibrillation

Manual Defibrillation Introduction

Introduces asynchronous defibrillation and synchronized cardioversion.

Manual Defibrillation Safety Information

Highlights critical safety precautions for manual defibrillation.

Manual Defibrillation View

Illustrates the typical screen display during manual defibrillation.

Manual Defibrillation Procedure

Details the step-by-step process for performing manual defibrillation therapy.

Synchronized Cardioversion

Explains how to synchronize defibrillation shocks with the patient's R-wave.

Remote Synchronized Cardioversion

Describes using an external ECG source for synchronized cardioversion.

Contact Impedance Indicator

Explains the indicator for assessing patient contact quality for therapy delivery.

CPR Feedback

CPR Feedback Introduction

Introduces the CPR feedback function when using the CPR sensor.

Operations with the CPR Sensor

Covers viewing waveforms, reviewing events, and managing CPR sensor data.

Using CPR Filter

Explains how to enable the CPR filter to improve ECG clarity during CPR.

Viewing CPR Feedback

Details how to view compression waveforms, CCI graphs, and rates.

Reviewing CPR Events

Explains how to access and review recorded CPR events.

Uploading CPR Data

Describes how to upload CPR sensor data to the equipment.

Noninvasive Pacing

Pacing Introduction

Explains the pacing function, ECG monitoring, and pace pulse delivery.

Pacing Safety Information

Highlights critical safety precautions for noninvasive pacing.

Pacing View

Illustrates the typical screen display during pacing operation.

Pacer Mode

Describes the demand and fixed modes for delivering pace pulses.

Preparing for Pacing

Details the steps for preparing the patient and equipment for pacing.

Fixed Mode Pacing

Explains the procedure for pacing using the fixed mode.

Monitoring Resp

Resp Introduction

Explains impedance respiration measurement and waveform display.

Resp Safety Information

Highlights critical safety precautions for respiration monitoring.

Resp Display

Illustrates the respiration monitoring display and its components.

Placing Resp Electrodes

Details the correct placement of electrodes for respiration monitoring.

Changing Resp Settings

Covers adjustments for gain, sweep, lead, and apnea time.

Resp Troubleshooting

Provides solutions for common problems encountered during respiration monitoring.

Monitoring PR

PR Introduction

Explains pulse rate measurement and its display characteristics.

Setting the PR Source

Details how to select the source for pulse rate measurement.

Adjusting Pulse Tone Volume

Explains how to change the volume of the pulse tone for PR alarms.

Monitoring SpO2

SpO2 Introduction

Explains SpO2 monitoring technique, display, and patient types.

Identifying SpO2 Modules

Helps identify different SpO2 modules based on connector color and logo.

SpO2 Safety Information

Highlights critical safety precautions for SpO2 monitoring.

SpO2 Measurement Limitations

Lists factors that can influence the accuracy of SpO2 measurements.

SpO2 Display

Illustrates the SpO2 display, including waveform, values, and indicators.

SpO2 Monitoring Procedure

Details the steps for applying sensors and connecting the SpO2 module.

Changing SpO2 Settings

Covers adjustments for pleth wave speed, limb monitoring, and alarm management.

SpO2 Desat Alarm

Explains the SpO2 Desaturation alarm and its settings.

Pitch Tone

Describes how SpO2 levels affect the pitch of audio tones.

SpO2 Troubleshooting

Provides solutions for common problems encountered during SpO2 monitoring.

Nellcor Information

Provides patent and licensing information for Nellcor SpO2 components.

Masimo Information

Provides patent and licensing information for Masimo SpO2 components.

Masimo End-User License Agreement

Details the legal agreement for using Masimo software and components.

Monitoring NIBP

NIBP Introduction

Explains the oscillometric method for automatic non-invasive blood pressure monitoring.

NIBP Safety Information

Highlights critical safety precautions for NIBP measurements.

NIBP Measurement Limitations

Lists conditions that may affect the accuracy or possibility of NIBP measurement.

Measurement Modes

Describes the Manual, Auto, and STAT modes for NIBP measurement.

NIBP Display

Illustrates the NIBP display showing systolic, diastolic, and mean pressures.

NIBP Measurement Procedure

Details the steps for preparing the patient and performing NIBP measurements.

Setting Initial Cuff Inflation Pressure

Explains how to manually set the initial cuff inflation pressure.

Setting Pressure Unit

Describes how to change the unit for pressure display (mmHg or kPa).

NIBP Troubleshooting

Provides solutions for common problems encountered during NIBP monitoring.

Monitoring Temp

Temperature Introduction

Explains the equipment's capability to monitor skin and core body temperature.

Temperature Display

Illustrates the temperature display showing values and alarm limits.

Temp Measurement Procedure

Details the steps for connecting probes and performing temperature measurements.

Setting the Temperature Unit

Explains how to change the temperature unit between Celsius and Fahrenheit.

Temperature Troubleshooting

Provides solutions for common problems encountered during temperature monitoring.

Monitoring IBP

IBP Introduction

Explains the function for monitoring invasive blood pressures.

IBP Safety Information

Highlights critical safety precautions for invasive blood pressure monitoring.

Zeroing IBP Transducer

Details the procedure for zeroing the IBP transducer to ensure accurate readings.

IBP Measurement Procedure

Details the steps for connecting the transducer and performing measurements.

Understanding the IBP Display

Illustrates the IBP display showing waveforms and numeric pressures.

Changing IBP Settings

Covers adjustments for pressure labels, wave settings, units, and filters.

IBP Troubleshooting

Provides solutions for common problems encountered during IBP monitoring.

Monitoring CO2

CO2 Introduction

Explains the CO2 monitoring technique using infrared light absorption.

Identifying CO2 Modules

Helps identify sidestream and microstream CO2 modules.

CO2 Safety Information

Highlights critical safety precautions for CO2 monitoring.

CO2 Measurement Limitations

Lists factors that may influence the accuracy of CO2 measurements.

CO2 Display

Illustrates the CO2 display showing FiCO2, EtCO2, awRR, and waveform.

Preparing for Measuring CO2

Details steps for connecting modules, lines, and adapters for CO2 measurement.

Changing CO2 Settings

Covers adjustments for alarms, units, wave settings, and operating modes.

Removing the Exhaust Gases from the System

Explains how to connect the outlet to a scavenging system for anesthetic gas removal.

CO2 Calibration

Describes the calibration procedure required for CO2 modules.

CO2 Troubleshooting

Provides solutions for common problems encountered during CO2 monitoring.

Oridion Information

Provides patent and licensing information for Oridion Microstream CO2 components.

Marking Events

Marking Events

Explains how to mark significant events during patient monitoring or therapy.

Freezing Waveforms

Freezing Waveforms

Describes how to freeze waveforms for detailed examination.

Reviewing Frozen Waveforms

Explains how to scroll through and examine frozen waveforms.

Unfreezing Waveforms

Details methods to exit the waveform freeze mode.

Recording Frozen Waveforms

Explains how to select and record specific frozen waveforms.

Review

Reviewing Events

Describes how to access and review recorded patient events.

Reviewing Tabular Trends

Explains how to view recorded tabular trends data.

Reviewing 12-Lead Reports

Guides on how to review the generated 12-lead ECG reports.

Reviewing CPR Events

Explains how to review CPR events recorded via the CPR sensor.

Data Management

Data Management Overview

Outlines the capabilities of the data management function.

Generating Patient Data

Explains the automatic creation and handling of patient data archives.

Editing Archived Patient Information

Describes how to modify previously saved patient information.

Reviewing Patient Events

Explains how to access and review archived patient events.

Exporting Patient Data

Details the procedure for exporting patient data to USB memory.

Recording

Using a Recorder

Provides instructions on operating the thermal recorder.

Recording Types

Lists the different types of recordings the equipment can generate.

Starting Recordings

Explains manual and automatic methods for initiating recordings.

Stopping Recordings

Details manual and automatic methods for stopping recordings.

Setting the Recorder

Covers configuration options for waveforms, length, speed, and gridlines.

Loading Paper

Provides instructions for loading new thermal paper into the recorder.

Removing Paper Jam

Describes the procedure for clearing paper jams from the recorder.

Cleaning the Recorder Print Head

Explains how to clean the recorder's print head for optimal performance.

Network Connection

Network Introduction

Introduces the network capabilities for data transmission.

General Network Settings

Covers configuring network type, IP address, and DNS settings.

Connecting the CMS

Details the process of connecting to the Central Monitoring System (CMS).

Connecting the HL7 Server

Explains how to establish a connection to an HL7 server.

Connecting the FTP Server

Describes the procedure for connecting to an FTP server.

Configuration Management

Configuration Management Introduction

Explains the purpose and capabilities of the configuration management function.

Modifying Configuration Management Password

Details how to change the password for accessing configuration settings.

Viewing Configurations

Explains how to access and view the current system configurations.

Exporting Configurations

Describes how to export current configurations to a USB flash memory.

Importing Configurations

Explains how to import configurations from a USB flash memory.

Changing Configurations

Covers modifying settings or restoring factory defaults.

Battery

Battery Introduction

Describes the equipment's battery system and on-screen indicators.

Battery Safety Information

Highlights critical safety precautions related to battery usage and handling.

Installing the Battery

Provides instructions for installing and replacing the device's batteries.

Battery Alarms

Explains various battery-related alarms and their meanings.

Conditioning the Battery

Details the procedure for conditioning batteries to extend their service life.

Checking Battery Performance

Explains how to check battery performance and when to replace them.

Charging the Battery

Describes how the batteries are charged, either in the equipment or via a charger.

Storing Batteries

Provides guidelines for storing batteries properly for extended periods.

Recycling the Batteries

Explains when and how to discard batteries according to regulations.

Care and Cleaning

General Points

Provides general rules for keeping the equipment and accessories clean.

Cleaning

Details the cleaning procedures and recommended cleaning agents.

Disinfecting

Explains the process for disinfecting the equipment as per servicing schedule.

Sterilization

States that sterilization is not recommended for the monitor unless indicated.

Maintenance

Maintenance Introduction

Emphasizes the importance of regular maintenance for equipment reliability.

Maintenance Safety Information

Highlights critical safety precautions for performing maintenance.

Routine Maintenance

Outlines periodic checks like shift checks and auto tests.

Function Checks

Describes specific checks to ensure equipment readiness, like recorder and ECG tests.

Preventive Maintenance

Details annual preventive maintenance tests and procedures.

Accessories

ECG Accessories

Lists ECG electrodes, trunk cables, and lead sets with compatibility and PN.

SpO2 Accessories

Details SpO2 extension cables and sensors, including types and compatibility.

NIBP Accessories

Lists NIBP hoses and cuffs, specifying models and applicable patients.

Temp Accessories

Details temperature probes, extension cables, and adapting cables.

IBP Accessories

Lists accessories for Invasive Blood Pressure monitoring.

CO2 Accessories

Lists accessories for CO2 monitoring, including microstream and sidestream modules.

Therapy Accessories

Lists accessories related to defibrillation and pacing therapies.

Miscellaneous

Lists other accessories such as batteries, test loads, and adapters.

Specifications

General Specifications

Provides overall safety, physical, and display characteristics.

Defibrillator Specifications

Details technical specifications for defibrillation modes and energy levels.

CPR Compression Specifications

Provides technical specifications for CPR compression measurement.

Pacer Specifications

Details technical specifications for pacing parameters and output.

Monitor Specifications

Provides technical specifications for monitoring functions like ECG, Resp, SpO2, etc.

Power Supply Specifications

Details specifications for AC power, DC adapter, and battery performance.

Recorder Specifications

Provides technical specifications for the integrated thermal recorder.

Alarm Specifications

Details technical specifications for alarm levels, categories, and limits.

Data Storage

Specifies the capacity and types of data stored by the equipment.

Wi-Fi Specifications

Details technical specifications for the wireless network connectivity.

Environmental Specifications

Outlines the operating and storage conditions for the equipment and modules.

Mindray Shockable Rhythm Analysis Algorithm

Rhythm Recognition and Annotation Methodology

Describes methods and criteria used for rhythm analysis and annotation.

Mindray Shockable Rhythm Analysis Algorithm Performance

Presents test results evaluating the algorithm's performance against standards.

EMC and Radio Regulatory Compliance

EMC

Provides electromagnetic compatibility guidance and declarations.

Radio Regulatory Compliance

States compliance with essential requirements of Directive 2014/53/EU.

Defibrillator Shift Checklist

Alarm Messages

Physiological Alarm Messages

Lists and explains physiological alarms, their levels, causes, and solutions.

Technical Alarm Messages

Lists and explains technical alarms, their levels, causes, and solutions.

Electrical Safety Inspection

Power Cord Plug

Details acceptance criteria for inspecting the power cord plug.

Device Enclosure and Accessories

Covers visual and contextual inspection of the device's exterior.

Device Labeling

Ensures that all required labels on the device are present and legible.

Protective Earth Resistance

Specifies the acceptable limits for protective earth resistance measurement.

Earth Leakage Test

Details the procedure and limits for performing earth leakage tests.

Patient Leakage Current

Specifies limits for patient leakage current measurements.

Mains on Applied Part Leakage

Details the test and limits for mains leakage current on applied parts.

Patient Auxiliary Current

Specifies limits for patient auxiliary current measurements.

Symbols and Abbreviations

Units

Lists common units of measurement used in the manual.

Symbols

Defines common symbols and mathematical notations used in the document.

Abbreviations and Acronyms

Provides a glossary of abbreviations and acronyms used throughout the manual.

Device Tracking

Declaration of Conformity

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