BeneHeart D3 and D2 Operators Manual Ver 9.0 Sept 2020

© Copyright 2017-2020 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. ■

Release time: 2020-09

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Revision: 9.0

Defibrillator/Monitor Operator’s Manual

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Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray 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 intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. and are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: ■

all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;

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the electrical installation of the relevant room complies with the applicable national and local requirements;

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the product is used in accordance with the instructions for use.

WARNING

• This equipment must be operated by skilled/trained clinical professionals. • It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

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Defibrillator/Monitor Operator’s Manual

Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to: ■

Malfunction or damage caused by improper use or man-made failure.

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Malfunction or damage caused by unstable or out-of-range power input.

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Malfunction or damage caused by force majeure such as fire and earthquake.

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Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.

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Malfunction of the instrument or part whose serial number is not legible enough.

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Others not caused by instrument or part itself.

Company Contact Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057, P.R.China

Website:

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

Defibrillator/Monitor Operator’s Manual

III

Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed.

Intended Audience This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients.

Illustrations All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your equipment.

Conventions

IV

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Italic text is used in this manual to quote the referenced chapters or sections.

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[ ] is used to enclose screen texts.

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→ is used to indicate operational procedures.

Defibrillator/Monitor Operator’s Manual

Contents 1 Safety ... 1 - 1 1.1 Safety Information ...1 - 1 1.1.1 Dangers ...1 - 1 1.1.2 Warnings ...1 - 1 1.1.3 Cautions ...1 - 2 1.1.4 Notes ...1 - 3 1.2 Equipment Symbols ...1 - 3 2 The Basics ... 2 - 1 2.1 Equipment Introduction ...2 - 1 2.2 Intended Use ...2 - 1 2.2.1 AED ...2 - 2 2.2.2 Manual Defibrillation ...2 - 2 2.2.3 Noninvasive Pacing ...2 - 2 2.2.4 ECG ...2 - 2 2.2.5 Resp ...2 - 2 2.2.6 PR ...2 - 2 2.2.7 SpO2 ... 2 - 2 2.2.8 NIBP ...2 - 2 2.2.9 CO2 ... 2 - 2 2.2.10 CPR Feedback ...2 - 2 2.3 Applied Parts ...2 - 3 2.4 Main Unit ...2 - 3 2.4.1 Front View ...2 - 3 2.4.2 Left View ...2 - 7 2.4.3 Right View ...2 - 8 2.4.4 Rear View ...2 - 8 2.5 External Paddles ...2 - 9 2.6 Display Views ... 2 - 10 3 Basic Operations and Settings ... 3 - 1 3.1 Equipment Installation ...3 - 1 3.1.1 Unpacking and Checking ...3 - 1 3.1.2 Environmental Requirements ...3 - 1 3.2 Basic Operation ...3 - 2 3.2.1 Connecting the AC Mains ...3 - 2 3.2.2 Installing the Battery ...3 - 2 3.2.3 Turning On the Equipment ...3 - 2 3.2.4 Starting Monitoring or Therapy ...3 - 3 3.2.5 Using the Main Menu ...3 - 3 3.2.6 Using the Navigation knob ...3 - 3 3.2.7 Editing Current Patient Information ...3 - 4 3.2.8 Turning Off the Equipment ...3 - 4 3.2.9 Auto Restoring to Last Configuration ...3 - 4 3.3 Changing General Settings ...3 - 5 3.3.1 Setting the Date and Time ...3 - 5 3.3.2 Adjusting the Screen Brightness ...3 - 5 Defibrillator/Monitor Operator’s Manual

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3.3.3 Changing Key Volume ...3 - 5 3.3.4 Selecting High Contrast Display ...3 - 5 3.3.5 Adjusting Waveform Position ...3 - 6 3.4 Analog Output ...3 - 6 4 Alarms ...4 - 1 4.1 Alarm Categories ...4 - 1 4.2 Alarm Levels ...4 - 1 4.3 Alarm Indicators ...4 - 2 4.3.1 Alarm Lamps ...4 - 2 4.3.2 Audible Alarms ...4 - 2 4.3.3 Alarm Messages ...4 - 2 4.3.4 Flashing Numerics ...4 - 3 4.3.5 Alarm Status Symbols ...4 - 3 4.4 Alarm Tone Configuration ...4 - 3 4.4.1 Changing the Alarm Volume ...4 - 3 4.4.2 Setting the Reminder Tones ...4 - 3 4.4.3 Setting the Interval between Alarm Sounds ...4 - 3 4.5 Understanding the Alarm Setup Menu ...4 - 4 4.5.1 Setting Alarm Properties for All Parameters ...4 - 4 4.5.2 Adjusting Alarm Limits Automatically ...4 - 4 4.6 Pausing Alarms ...4 - 6 4.7 Switching Alarms Off ...4 - 6 4.8 Switching Off Alarm Sounds ...4 - 6 4.9 Resetting Alarms ...4 - 6 4.10 Latching Alarms ...4 - 7 4.11 Clearing Technical Alarms ...4 - 7 4.12 Testing Alarms ...4 - 7 4.13 Actions When an Alarm Occurs ...4 - 8 5 Monitoring ECG ...5 - 1 5.1 ECG Introduction ...5 - 1 5.2 ECG Safety Information ...5 - 1 5.3 Monitoring View ...5 - 2 5.4 Preparing for ECG Monitoring and Measurement ...5 - 2 5.4.1 Preparing the Patient Skin ...5 - 2 5.4.2 ECG Monitoring with Electrodes ...5 - 2 5.4.3 ECG Measurement with Electrode Pads ...5 - 3 5.4.4 ECG Measurement with External Paddles ...5 - 5 5.4.5 Checking Paced Status ...5 - 5 5.5 ECG Display ...5 - 6 5.6 Changing ECG Settings ...5 - 6 5.6.1 Selecting the Lead Type ...5 - 6 5.6.2 Choosing the ECG Standard ...5 - 6 5.6.3 Selecting the Lead of Displayed ECG Waveform ...5 - 6 5.6.4 Setting the ECG Waveform Layout ...5 - 7 5.6.5 Changing ECG Waveform Size ...5 - 7 5.6.6 Changing ECG Waveform Speed ...5 - 7 2

Defibrillator/Monitor Operator’s Manual

5.6.7 Setting the ECG Filter ...5 - 7 5.6.8 Switching On or Off the Notch Filter ...5 - 7 5.6.9 Adjusting the QRS Volume ...5 - 8 5.7 Arrhythmia Analysis ...5 - 8 5.7.1 Understanding the Arrhythmia Events ...5 - 8 5.7.2 Switching Arrhythmia Analysis On and Off ...5 - 9 5.7.3 Changing Arrhythmia Alarm Settings ...5 - 9 5.7.4 Changing Arrhythmia Threshold Settings ...5 - 10 5.7.5 Initiating Arrhythmia Relearning Manually ... 5 - 10 5.7.6 Automatic Arrhythmia Relearn ... 5 - 11 5.8 Calibrating ECG ... 5 - 11 5.9 ECG Troubleshooting ... 5 - 11 6 AED ... 6 - 1 6.1 AED Introduction ...6 - 1 6.2 AED Safety Information ...6 - 1 6.3 AED View ...6 - 2 6.4 AED Procedure ...6 - 2 6.5 Shock Advised ...6 - 3 6.6 No Shock Advised (NSA) ...6 - 4 6.7 CPR ...6 - 4 6.7.1 CPR Metronome ...6 - 4 6.8 AED Sound Recording ...6 - 5 6.9 AED Setup ...6 - 5 7 Manual Defibrillation ... 7 - 1 7.1 Manual Defibrillation Introduction ...7 - 1 7.2 Manual Defibrillation Safety Information ...7 - 1 7.3 Manual Defibrillation View ...7 - 2 7.4 Manual Defibrillation Procedure ...7 - 3 7.4.1 Using Pediatric Paddles ...7 - 5 7.4.2 Using Internal Paddles ...7 - 5 7.5 Synchronized Cardioversion ...7 - 6 7.5.1 Performing Synchronized Cardioversion ...7 - 7 7.5.2 Delivering Additional Synchronized Shocks ...7 - 7 7.5.3 Disabling the Sync Function ...7 - 7 7.6 Remote Synchronized Cardioversion ...7 - 8 7.7 Contact Impedance Indicator ...7 - 9 8 CPR Feedback ... 8 - 1 8.1 CPR Feedback Introduction ...8 - 1 8.2 Operations with the CPR Sensor ...8 - 1 8.2.1 Connecting the CPR Sensor ...8 - 1 8.2.2 Using CPR Filter ...8 - 2 8.2.3 Viewing CPR Feedback ...8 - 3 8.2.4 Reviewing CPR Events ...8 - 3 8.2.5 Uploading CPR Data ...8 - 4

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9 Noninvasive Pacing ...9 - 1 9.1 Pacing Introduction ...9 - 1 9.2 Pacing Safety Information ...9 - 1 9.3 Pacing View ...9 - 2 9.4 Pacer Mode ...9 - 2 9.5 Preparing for Pacing ...9 - 3 9.5.1 Demand Mode Pacing ...9 - 3 9.5.2 Fixed Mode Pacing ...9 - 4 10 Monitoring Resp ...10 - 1 10.1 Resp Introduction ... 10 - 1 10.2 Resp Safety Information ... 10 - 1 10.3 Resp Display ... 10 - 1 10.4 Placing Resp Electrodes ... 10 - 1 10.4.1 Optimizing Lead Placement for Resp ... 10 - 2 10.4.2 Changing Resp Settings ... 10 - 3 10.5 Resp Troubleshooting ... 10 - 3 11 Monitoring PR ...11 - 1 11.1 PR Introduction ... 11 - 1 11.2 Adjusting Pulse Tone Volume ... 11 - 1 12 Monitoring SpO2 ... 12 - 1 12.1 SpO2 Introduction ... 12 - 1 12.2 Identifying SpO2 Modules ... 12 - 1 12.3 SpO2 Safety Information ... 12 - 1 12.4 SpO2 Measurement Limitations ... 12 - 2 12.5 SpO2 Display ... 12 - 3 12.6 SpO2 Monitoring Procedure ... 12 - 4 12.7 Changing SpO2 Settings ... 12 - 4 12.7.1 Changing the Speed of the Pleth Wave ... 12 - 4 12.7.2 Monitoring SpO2 and NIBP on the Same Limb ... 12 - 4 12.7.3 Sat-Seconds Alarm Management (for Nellcor SpO2) ... 12 - 4 12.7.4 Setting SpO2 Sensitivity (for Mindray SpO2) ... 12 - 5 12.7.5 Setting SpO2 Sensitivity (for Masimo SpO2) ... 12 - 5 12.7.6 Changing Averaging Time (for Masimo SpO2) ... 12 - 5 12.7.7 Enabling FastSAT (for Masimo SpO2) ... 12 - 5 12.7.8 Displaying SIQ (for Masimo SpO2) ... 12 - 5 12.7.9 Displaying PI (for Masimo SpO2) ... 12 - 6 12.7.10 Setting the Alarm Delay Time (for Masimo SpO2) ... 12 - 6 12.8 SpO2 Desat Alarm ... 12 - 6 12.9 Pitch Tone ... 12 - 6 12.10 SpO2 Troubleshooting ... 12 - 6 12.11 Nellcor Information ... 12 - 7 12.12 Masimo Information ... 12 - 7 12.13 Masimo End-User License Agreement ... 12 - 8

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Defibrillator/Monitor Operator’s Manual

13 Monitoring NIBP ...13 - 1 13.1 NIBP Introduction ... 13 - 1 13.2 NIBP Safety Information ... 13 - 1 13.3 NIBP Measurement Limitations ... 13 - 2 13.4 Measurement Modes ... 13 - 2 13.5 NIBP Display ... 13 - 2 13.6 NIBP Measurement Procedure ... 13 - 3 13.6.1 Preparing the Patient ... 13 - 3 13.6.2 Preparing for NIBP Measurement ... 13 - 3 13.6.3 Starting and Stopping NIBP Measurements ... 13 - 3 13.6.4 Correcting the Measurement ... 13 - 3 13.6.5 Starting Auto NIBP Measurements ... 13 - 3 13.6.6 Starting a STAT Measurement ... 13 - 4 13.7 Setting Initial Cuff Inflation Pressure ... 13 - 4 13.8 Setting Pressure Unit ... 13 - 4 13.9 NIBP Troubleshooting ... 13 - 4 14 Monitoring CO2 ...14 - 1 14.1 CO2 Introduction ... 14 - 1 14.2 CO2 Safety Information ... 14 - 1 14.3 CO2 Measurement Limitations ... 14 - 1 14.4 CO2 Display ... 14 - 2 14.5 Preparing for Measuring CO2 ...14 - 2 14.5.1 Measuring CO2 Using the CO2 Module ... 14 - 2 14.5.2 Zeroing the CO2 Sensor ... 14 - 3 14.6 Changing CO2 Settings ... 14 - 4 14.6.1 Changing CO2 Alarm Settings ... 14 - 4 14.6.2 Setting Pressure Unit ... 14 - 4 14.6.3 Changing CO2 Wave Settings ... 14 - 4 14.6.4 Changing CO2 Operating Mode ... 14 - 4 14.6.5 Setting the Auto Standby Time ... 14 - 5 14.6.6 Setting the Apnea Alarm Delay ... 14 - 5 14.6.7 Selecting Gas Compensations ... 14 - 5 14.6.8 Setting Humidity Compensation ... 14 - 5 14.6.9 Barometric Pressure Compensation ... 14 - 5 14.7 Removing the Exhaust Gases from the System ... 14 - 6 14.8 CO2 Calibration ... 14 - 6 14.9 CO2 Troubleshooting ... 14 - 6 15 Marking Events ...15 - 1 16 Freezing Waveforms ...16 - 1 16.1 Freezing Waveforms ... 16 - 1 16.2 Reviewing Frozen Waveforms ... 16 - 1 16.3 Unfreezing Waveforms ... 16 - 1 16.4 Recording Frozen Waveforms ... 16 - 1 17 Review ...17 - 1

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17.1 Reviewing Events ... 17 - 1 17.2 Reviewing Tabular Trends ... 17 - 1 17.3 Reviewing CPR Events ... 17 - 2 18 Data Management ...18 - 1 18.1 Data Management Overview ... 18 - 1 18.2 Generating Patient Data ... 18 - 1 18.3 Editing Archived Patient Information ... 18 - 1 18.4 Reviewing Patient Events ... 18 - 1 18.5 Exporting Patient Data ... 18 - 1 19 Recording ...19 - 1 19.1 Using a Recorder ... 19 - 1 19.2 Recording Types ... 19 - 1 19.3 Starting Recordings ... 19 - 2 19.3.1 Manually Starting Recordings ... 19 - 2 19.3.2 Automatic Recordings ... 19 - 2 19.4 Stopping Recordings ... 19 - 2 19.4.1 Stopping Recordings Manually ... 19 - 2 19.4.2 Stopping Recordings Automatically ... 19 - 2 19.5 Setting the Recorder ... 19 - 3 19.5.1 Selecting Waveforms for Recording ... 19 - 3 19.5.2 Setting the Realtime Recording Length ... 19 - 3 19.5.3 Changing the Recording Speed ... 19 - 3 19.5.4 Switching Gridlines On or Off ... 19 - 3 19.6 Loading Paper ... 19 - 3 19.7 Removing Paper Jam ... 19 - 4 19.8 Cleaning the Recorder Print Head ... 19 - 4 20 Network Connection ...20 - 1 20.1 Network Introduction ... 20 - 1 20.2 General Network Settings ... 20 - 1 20.2.1 Selecting a Network Type ... 20 - 1 20.2.2 Storing Preset Sites ... 20 - 1 20.2.3 Setting DNS ... 20 - 1 20.3 Connecting the CMS ... 20 - 2 20.4 Connecting the HL7 Server ... 20 - 2 21 Configuration Management ...21 - 1 21.1 Configuration Management Introduction ... 21 - 1 21.2 Modifying Configuration Management Password ... 21 - 1 21.3 Viewing Configurations ... 21 - 1 21.4 Exporting Configurations ... 21 - 2 21.5 Importing Configurations ... 21 - 2 21.6 Changing Configurations ... 21 - 2

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Defibrillator/Monitor Operator’s Manual

21.6.1 General Setup Menu ... 21 - 2 21.6.2 Manual Defib Setup Menu ... 21 - 3 21.6.3 AED Setup Menu ... 21 - 4 21.6.4 Pacer Setup Menu ... 21 - 5 21.6.5 CPR Setup Menu ... 21 - 5 21.6.6 ECG Setup Menu ... 21 - 5 21.6.7 Resp Setup Menu ... 21 - 8 21.6.8 SpO2 Setup Menu ... 21 - 8 21.6.9 PR Setup Menu ... 21 - 9 21.6.10 NIBP Setup Menu ... 21 - 9 21.6.11 CO2 Setup Menu ...21 - 10 21.6.12 Alarm Setup Menu ...21 - 11 21.6.13 Waveform Setup Menu ...21 - 11 21.6.14 Mark Event Setup Menu ...21 - 12 21.6.15 Record Setup Menu ...21 - 12 21.6.16 Data Management Setup Menu ...21 - 13 21.6.17 Test Setup Menu ...21 - 13 21.6.18 Network Setup ...21 - 13 21.6.19 Others Menu ...21 - 14 22 Battery ...22 - 1 22.1 Battery Introduction ... 22 - 1 22.2 Battery Safety Information ... 22 - 1 22.3 Installing the Battery ... 22 - 2 22.4 Battery Alarms ... 22 - 2 22.4.1 No Battery Alarm ... 22 - 2 22.4.2 Low Battery Alarm ... 22 - 2 22.4.3 Battery Aged Alarm ... 22 - 2 22.4.4 Battery Error Alarm ... 22 - 2 22.5 Conditioning the Battery ... 22 - 3 22.6 Checking Battery Performance ... 22 - 3 22.7 Charging the Battery ... 22 - 3 22.8 Storing Batteries ... 22 - 3 22.9 Recycling the Batteries ... 22 - 4 23 Care and Cleaning ...23 - 1 23.1 General Points ... 23 - 1 23.2 Cleaning ... 23 - 2 23.3 Disinfecting ... 23 - 2 23.4 Sterilization ... 23 - 2 24 Maintenance ...24 - 1 24.1 Maintenance Introduction ... 24 - 1 24.2 Maintenance Safety Information ... 24 - 1 24.3 Routine Maintenance ... 24 - 1 24.3.1 Auto Test ... 24 - 2 24.3.2 User Test ... 24 - 3 24.4 Function Checks ... 24 - 5

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24.4.1 Recorder Check ... 24 - 5 24.4.2 ECG Cable Test ... 24 - 5 24.4.3 Manual Defibrillation Test ... 24 - 5 24.4.4 Pacing Test ... 24 - 6 24.5 Preventive Maintenance ... 24 - 7 24.5.1 Performing Tests in the Installation Mode ... 24 - 7 24.5.2 Electrical Safety Tests ... 24 - 7 25 Accessories ...25 - 1 25.1 ECG Accessories ... 25 - 1 25.1.1 ECG Electrodes ... 25 - 1 25.1.2 12-pin Trunk Cable ... 25 - 1 25.1.3 Lead Sets ... 25 - 2 25.1.4 Adapting Cable ... 25 - 2 25.2 SpO2 Accessories ... 25 - 3 25.2.1 Extension Cables ... 25 - 3 25.2.2 SpO2 Sensors ... 25 - 3 25.3 NIBP Accessories ... 25 - 4 25.3.1 NIBP Hoses ... 25 - 4 25.3.2 Cuffs ... 25 - 4 25.4 CO2 Accessories ... 25 - 5 25.5 Therapy Accessories ... 25 - 6 25.6 Miscellaneous ... 25 - 6 A Specifications ... A - 1 A.1 General Specifications ... A - 1 A.1.1 Safety Specifications ... A - 1 A.1.2 Physical Specifications ... A - 1 A.1.3 Display Specifications ... A - 1 A.1.4 Audio Indicators ... A - 1 A.1.5 Interface Specifications ... A - 2 A.1.6 Signal Outputs Specifications ... A - 2 A.2 Defibrillator Specifications ... A - 2 A.3 CPR Compression Specifications ... A - 5 A.4 Pacer Specifications ... A - 5 A.5 Monitor Specifications ... A - 5 A.5.1 ECG Specifications (from ECG Lead Set) ... A - 5 A.5.2 ECG Specifications (from Defibrillation Electrodes) ... A - 7 A.5.3 Resp Specifications ... A - 9 A.5.4 SpO2 Specifications ... A - 9 A.5.5 PR Specifications ...A - 10 A.5.6 NIBP Specifications ...A - 10 A.5.7 CO2 Specifications ...A - 11 A.6 Power Supply Specifications...A - 12 A.6.1 External Power Supply Specifications ...A - 12 A.6.2 Battery Specifications ...A - 12 A.7 Recorder Specifications ...A - 14 A.8 Alarm Specifications ...A - 14

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Defibrillator/Monitor Operator’s Manual

A.9 Data Storage ...A - 14 A.10 Wi-Fi Specifications ...A - 15 A.11 Environmental Specifications ...A - 15 B Mindray Shockable Rhythm Analysis Algorithm ...B - 1 B.1 Rhythm Recognition and Annotation Methodology ... B - 1 B.1.1 Database for Evaluation of Mindray Algorithm Performance ... B - 1 B.1.2 Rhythm Categories ... B - 1 B.2 Mindray Shockable Rhythm Analysis Algorithm Performance ... B - 2 C EMC and Radio Regulatory Compliance ...C - 1 C.1 EMC ... C - 1 C.2 Radio Regulatory Compliance ... C - 4 D Defibrillator Shift Checklist ... D - 1 E Alarm Messages ... E - 1 E.1 Physiological Alarm Messages ...E - 1 E.2 Technical Alarm Messages ...E - 2 F Electrical Safety Inspection ... F - 1 F.1 Power Cord Plug ...F - 1 F.2 Device Enclosure and Accessories ...F - 1 F.2.1 Visual Inspection ...F - 1 F.2.2 Contextual Inspection ...F - 1 F.3 Device Labeling ...F - 2 F.4 Protective Earth Resistance ...F - 2 F.5 Earth Leakage Test ...F - 2 F.6 Patient Leakage Current ...F - 2 F.7 Mains on Applied Part Leakage ...F - 3 F.8 Patient Auxiliary Current ...F - 3 G Symbols and Abbreviations ... G - 1 G.1 Units ...G - 1 G.2 Symbols ...G - 2 G.3 Abbreviations and Acronyms ...G - 2 H Device Tracking ... H - 1 I Declaration of Conformity ... I - 1

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Defibrillator/Monitor Operator’s Manual

1

Safety

1.1

Safety Information DANGER

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

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

CAUTION

• Indicates a potential hazard or unsafe 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 get the most from your product.

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 from 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.

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• 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 accessories 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. • The equipment is not intended to be used within the Magnetic Resonance (MR) environment. • Before each use, the operator must check the equipment condition to ensure that the equipment is ready for operation. • 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. • 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 electrode pads or paddles away from internal pacemaker generator if possible to help prevent damage to the pacemaker. • Do not place the equipment or accessories in any position that might cause it to fall on the patient. • Do not start or operate the equipment unless the setup was verified to be correct. • 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. • If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check the equipment for proper functioning. • Physiological data and alarm messages provided by the equipment should not be used as the sole basis for diagnosis or therapy decisions. They must be used in conjunction with clinical signs and symptoms. Misinterpretation of the measured values or other parameters can endanger the patient.

• 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. • When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach.

1.1.3

Cautions CAUTION N

• 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

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Defibrillator/Monitor Operator’s Manual

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. • Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the patient cabling. • 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. • Never charge and deliver shock frequently in non-clinical situations. Otherwise equipment damage could occur.

1.1.4

Notes NOTE

• Put the equipment in a location where you can easily view and operate the equipment. • The equipment uses 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 operates 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 Symbol

Description

Symbol

Description

Refer to instruction manual/booklet

General warning sign

Dangerous voltage

Shock button

Manufacturer

Date of manufacture

Battery indicator

Alternating current

Equipotentiality

Computer network

DEFIBRILLATION-PROOF TYPE CF APPLIED PART

DEFIBRILLATION-PROOF TYPE BF APPLIED PART

Protected against solid foreign objects of 1,0 mm Ø and greater

Protected against solid foreign objects of 1,0 mm Ø and greater

Protection against vertically falling water drops

Protected against splashing water

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Symbol

Description

Symbol

Description

Menu

Graphical record

USB connector

Input/output

Gas inlet

Gas outlet

Humidity limitations

Atmospheric pressure limitations

Temperature limitations

Non-ionizing electromagnetic radiation

Stacking limit by number

Keep dry

This way up

Fragile; handle with care

Serial number

Unlocking

Authorised representative in the European Community

General symbol for recovery/recyclable

NIBP start/stop key

The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. Note: The product complies with the Council Directive 2011/65/EU. The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased it. * For system products, this label may be attached to the main unit only.

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Defibrillator/Monitor Operator’s Manual

2

The Basics

2.1

Equipment Introduction The BeneHeart D3/BeneHeart D2 Defibrillator/Monitor (hereinafter called the equipment) is a lightweight and portable defibrillator/monitor. It provides four operating modes: Monitor, Manual Defib, AED and Pacer. ■

Monitor Mode In the Monitor mode, the equipment is intended for monitoring, displaying, reviewing, storing and printing multiple physiological parameters and waveforms including ECG, pulse oximetry (SpO2), respiration (Resp), pulse rate (PR), non-invasive blood pressure (NIBP) and carbon dioxide (CO2).

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AED Mode In the 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.

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

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

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Charge; and

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Deliver the shock. Defibrillation may be performed through electrode pads, external and internal paddles. In the Manual Defib mode, you can also perform synchronized cardioversion. If desired, use of Manual Defib mode may be password protected.

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Pacer Mode The Pacer mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through electrode pads. Use of Pacer mode may also be password protected.

The equipment can be powered by smart lithium ion batteries which are rechargeable and maintenance-free. You can easily determine the remaining battery charge by viewing the battery power gauge displayed on the screen or by checking the indicator on the battery itself. An external AC mains or a DC power supply connected through a DC/AC adapter may also be used as a power source and for continuous battery charging. The equipment can be connected to a Central Monitoring System (hereinafter called CMS) through wired and wireless networks. The equipment automatically stores patient data in an internal storage card. You can also export the data through the USB port for viewing and editing on a PC through the data management software.

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Intended Use The equipment is intended for external defibrillation, internal defibrillation, synchronized cardioversion and semi-automated external defibrillation (AED). It can also be used for non-invasive external pacing as well as ECG, SpO2, Resp, PR, NIBP and CO2 monitoring. The equipment is for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation. The equipment is intended to be used by qualified medical personnel trained in the operation of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation.

Defibrillator/Monitor Operator’s Manual

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