MINDRAY
BeneHeart D1 Operators Manual Rev 9.0 Jan 2019
Operators Manual
110 Pages
Preview
Page 1
BeneHeart D1
Automated External Defibrillator
Operator’s Manual
© Copyright 2013-2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. ■
Release time: January 2019
■
Revision: 9.0
BeneHeart D1 Automated External Defibrillator Operator’s Manual
I
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 copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or 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, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. and are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.
Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or 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;
■
the electrical installation of the relevant room complies with the applicable national and local requirements; and
■
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.
II
BeneHeart D1 Automated External Defibrillator 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.
■
Malfunction or damage caused by unstable or out-of-range power input.
■
Malfunction or damage caused by force majeure such as fire and earthquake.
■
Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.
■
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:
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
BeneHeart D1 Automated External Defibrillator 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
■
Italic text is used in this manual to quote the referenced chapters or sections.
■
[ ] is used to enclose screen texts.
■
→ is used to indicate operational procedures.
BeneHeart D1 Automated External Defibrillator 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 - 2 1.2 Equipment Symbols ...1 - 3 2 The Basics ... 2 - 1 2.1 Overview ...2 - 1 2.2 Intended Use ...2 - 1 2.2.1 AED ...2 - 1 2.2.2 Manual Defibrillation ...2 - 1 2.2.3 ECG ...2 - 2 2.2.4 CPR Feedback ...2 - 2 2.2.5 Applied Parts ...2 - 2 2.3 Main Unit ...2 - 2 2.3.1 Front View ...2 - 2 2.3.2 Side View ...2 - 3 2.3.3 Rear View ...2 - 4 2.4 Display Views ...2 - 5 2.5 Soft Key Symbols ...2 - 6 3 Basic Operations and Settings ... 3 - 1 3.1 Installation ...3 - 1 3.1.1 Unpacking and Checking ...3 - 1 3.1.2 Environmental Requirements ...3 - 1 3.1.3 Installing the Battery ...3 - 2 3.1.4 Connecting Electrode Pads ...3 - 2 3.2 Basic Operation ...3 - 2 3.2.1 Turning Power On ...3 - 2 3.2.2 Changing General Settings ...3 - 2 3.2.3 Turning off the Equipment ...3 - 3 3.2.4 Auto Restoring to Last Configuration ...3 - 3 3.3 Post Use Procedure ...3 - 4 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 Audible Alarms ...4 - 2 4.3.2 Alarm Message ...4 - 2 4.3.3 Alarm Status Symbols ...4 - 2 4.4 Alarm Tone Configuration ...4 - 2 4.4.1 Changing the Alarm Volume ...4 - 2
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4.4.2 Pausing Alarm Sounds ...4 - 3 4.4.3 Switching Off Alarm Sounds ...4 - 3 4.5 Reminder Tones ...4 - 3 4.6 Clearing Technical Alarms ...4 - 3 4.7 When an Alarm Occurs ...4 - 3 5 AED ...5 - 1 5.1 Overview ...5 - 1 5.2 Safety ...5 - 1 5.3 AED View ...5 - 2 5.4 AED Procedure ...5 - 3 5.5 Shock Advised ...5 - 4 5.6 No Shock Advised (NSA) ...5 - 4 5.7 CPR ...5 - 4 5.7.1 CPR Metronome ...5 - 5 5.8 AED Sound Recording ...5 - 5 5.9 AED Setup ...5 - 5 6 Manual Defibrillation ...6 - 1 6.1 Overview ...6 - 1 6.2 Safety ...6 - 1 6.3 Manual Defibrillation View ...6 - 2 6.4 Manual Defibrillation Procedure ...6 - 3 6.5 Synchronized Cardioversion ...6 - 4 6.5.1 Performing Synchronized Cardioversion ...6 - 4 6.5.2 Delivering Additional Synchronized Shocks ...6 - 5 6.5.3 Disabling the Sync Function ...6 - 5 7 CPR Feedback ...7 - 1 7.1 Overview ...7 - 1 7.2 Connecting the CPR Sensor ...7 - 1 7.3 Viewing CPR Feedback ...7 - 1 8 Monitoring ECG ...8 - 1 8.1 Overview ...8 - 1 8.2 Safety ...8 - 1 8.3 ECG View ...8 - 1 8.4 Preparing to Monitor ECG ...8 - 2 8.4.1 ECG Monitoring with Electrodes ...8 - 2 8.4.2 ECG Monitoring with Pads ...8 - 2 8.5 Changing ECG Settings ...8 - 3 8.5.1 Selecting Lead Type ...8 - 3 8.5.2 Setting Gain ...8 - 3 8.5.3 Choosing AHA or IEC Lead Placement ...8 - 3 8.5.4 Setting Filter Mode ...8 - 3 8.6 Arrhythmia Analysis ...8 - 4
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BeneHeart D1 Automated External Defibrillator Operator’s Manual
8.6.1 Understanding the Arrhythmia Events ...8 - 4 8.6.2 Setting Arrhythmia Analysis ...8 - 5 8.6.3 Changing Arrhythmia Threshold Settings ...8 - 5 8.6.4 Automatic Arrhythmia Relearn ...8 - 5 8.7 ECG Troubleshooting ...8 - 6 9 Data Management ... 9 - 1 9.1 Introduction ...9 - 1 9.2 Recommended USB Flash Memory ...9 - 1 9.3 Exporting Data ...9 - 1 10 Configuration Management ...10 - 1 10.1 Introduction ... 10 - 1 10.2 Viewing System Configuration ... 10 - 1 10.3 Password ... 10 - 1 10.4 Accessing Configuration Management ... 10 - 1 10.5 Restoring Factory Default Configuration ... 10 - 1 10.6 List of Configuration Items ... 10 - 2 10.6.1 General Setup Menu ... 10 - 2 10.6.2 AED Setup Menu ... 10 - 2 10.6.3 Manual Defib Setup Menu ... 10 - 3 10.6.4 CPR Setup Menu ... 10 - 3 10.6.5 ECG Setup Menu ... 10 - 3 10.6.6 Alarm Setup Menu ... 10 - 3 10.6.7 Test Setup Menu ... 10 - 4 10.6.8 Network Setup Menu ... 10 - 4 10.6.9 WLAN Setup Menu ... 10 - 4 10.6.10 Certificates Maintenance Menu ... 10 - 5 10.6.11 Config. Menu ... 10 - 5 11 Battery ...11 - 1 11.1 Introduction ... 11 - 1 11.2 Battery Alarms ... 11 - 1 11.2.1 Low Battery Alarm ... 11 - 1 11.2.2 Battery Aged Alarm ... 11 - 2 11.2.3 Battery Error Alarm ... 11 - 2 11.3 Replacing Batteries ... 11 - 2 11.4 Charging Batteries ... 11 - 3 11.5 Storing Batteries ... 11 - 3 11.6 Recycling the Batteries ... 11 - 3 12 Care and Cleaning ...12 - 1 12.1 General Points ... 12 - 1 12.2 Cleaning ... 12 - 1 12.3 Disinfecting ... 12 - 2 13 Maintenance and Testing ...13 - 1 13.1 Overview ... 13 - 1
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13.2 Maintenance and Testing Schedule ... 13 - 2 13.3 Carrying Out Maintenance and Testing ... 13 - 2 13.3.1 Power-On Test ... 13 - 2 13.3.2 Real-Time Test ... 13 - 2 13.3.3 Battery Insert Test ... 13 - 2 13.3.4 Auto Test ... 13 - 2 13.3.5 User Test ... 13 - 3 13.3.6 Electrical Safety Tests ... 13 - 3 13.4 AED ALERT ... 13 - 3 13.4.1 Accessing AED ALERT ... 13 - 3 13.4.2 Viewing the Device Information ... 13 - 3 13.4.3 Managing Devices ... 13 - 4 13.4.4 Managing Users ... 13 - 4 14 Troubleshooting ...14 - 1 14.1 General Problems ... 14 - 1 14.2 Alarm Messages ... 14 - 1 14.3 Physiological Alarm Messages ... 14 - 2 14.4 Technical Alarm Messages ... 14 - 2 15 Accessories ...15 - 1 15.1 ECG Accessories ... 15 - 1 15.2 Therapy Accessories ... 15 - 2 15.3 Miscellaneous ... 15 - 2 A Specifications ... A - 1 A.1 General Specifications ... A - 1 A.2 Defibrillator Specifications ... A - 1 A.3 CPR Compression Specifications ... A - 3 A.4 Monitor Specifications ... A - 4 A.5 Power Supply Specifications ... A - 5 A.6 Alarm Specifications ... A - 6 A.7 Data Management Specifications ... A - 6 A.8 Wi-Fi Specifications ... A - 6 A.9 Environmental Specifications ... A - 7 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 BeneHeart D1 Inspection Record ... D - 1 E Prompt Messages ... E - 1
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BeneHeart D1 Automated External Defibrillator Operator’s Manual
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 Patient Leakage Current ...F - 2 F.5 Mains on Applied Part Leakage ...F - 2 F.6 Patient Auxiliary Current ...F - 2 G Symbols and Abbreviations ... G - 1 G.1 Units ...G - 1 G.2 Symbols ...G - 1 G.3 Abbreviations and Acronyms ...G - 2 H Device Tracking ... H - 1 I Declaration of Conformity ... I - 1
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BeneHeart D1 Automated External Defibrillator Operator’s Manual
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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 N
• 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.
• 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.
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• 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.
• 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 equipment 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
• Put the equipment in a location where you can easily view and operate the equipment. • 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. • This manual describes all features and options. Your equipment may not have all of them. • To ensure that the equipment is ready for any urgent use, keep it with battery installed and pads preconnected. • If the equipment has been dropped or mishandled, perform a user test. If any item fails, contact the authorized service personnel.
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BeneHeart D1 Automated External Defibrillator Operator’s Manual
1.2
Equipment Symbols Refer to instruction manual/ booklet
General warning sign
Shock button
Dangerous voltage
Unlocking
Stand-by
Manufacturer
Date of manufacture
Dust-protected Protected against splashing water
Maximum stacks
Serial number
USB connector
Open the battery door as indicated
Do not expose the battery to high heat or open flames. Do not incinerate the battery.
Do not crush the battery.
Do not mutilate the battery or open the battery case.
Fragile
Keep dry
Right side up
Temperature limitations
Humidity limitations
Atmospheric pressure limitations
General symbol for recovery/ recyclable
Non-ionizing electromagnetic radiation
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive.
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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.
1-4
BeneHeart D1 Automated External Defibrillator Operator’s Manual
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The Basics
It is important to understand that survival rates for sudden cardiac arrest are directly related to how soon victims receive treatment. For every minute of delay, the chance of survival declines by 7% to 10%. Treatment cannot assure survival. In some patients, the underlying problem causing the cardiac arrest is simply not survivable despite any available care.
2.1
Overview The BeneHeart D1 (hereinafter called the equipment) is a lightweight and portable automated external defibrillator. There are two types of configuration: the equipment configured with AED, manual defibrillation and ECG monitoring functions, while the equipment configured with only AED function. The equipment configured with AED, manual defibrillation and ECG monitoring functions provides two operating modes: AED and Manual Defib modes. The equipment configured with only AED function provides only 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. In the 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 is performed through multifunction electrode pads. In Manual Defib mode, you can also perform synchronized cardioversion. In Manual Defib mode, the equipment also provides monitoring, displaying and storing of 3-lead ECG. The equipment can be powered by a supplied disposable battery or a smart lithium ion battery which is rechargeable and maintenance-free. You can easily determine the remaining battery charge by viewing the battery power gauge displayed on the screen. For rechargeable batteries, you can also check the indicator on the battery itself. The equipment automatically stores patient data in an internal storage card. You can also export the data through the USB port for viewing on a PC through the data management software.
2.2
Intended Use The equipment configured with AED, manual defibrillation and ECG monitoring functions is intended for automatic defibrillation (AED) and manual defibrillation treatments. It guides operators through Cardiopulmonary resuscitation (CPR) and can also be used for ECG monitoring. The equipment configured with only AED function is intended for AED. It also guides operators throughout CPR.The equipment is for use in 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.
2.2.1
AED The AED mode is to be used only on cardio arrest patients. The patients must be:
2.2.2
■
Unresponsive
■
Not breathing or not breathing normally
Manual Defibrillation Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is intended for termination of atrial fibrillation.
BeneHeart D1 Automated External Defibrillator Operator’s Manual
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2.2.3
ECG The ECG monitoring function is used to monitor and/or record the patient’s ECG waveform and heart rate.
2.2.4
CPR Feedback The CPR sensor can be connected to the equipment to provide real-time CPR feedback, including the chest compression depth, rate and interruption time.
2.2.5
Applied Parts The applied parts of the equipment are: ■
ECG electrodes and leadwires
■
Multifunction electrode pads
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CPR sensor
2.3
Main Unit
2.3.1
Front View
1
6
2
7
3
8
4
5 9
1.
Pads connector It is used to connect the multifunction electrode pads.
2.
3.
2-2
Status indicator ◆
Green:
All the tests are passed, and the equipment operates properly.
◆
Red
Failure is detected on the equipment.
Display screen
BeneHeart D1 Automated External Defibrillator Operator’s Manual
4.
Soft keys They are corresponding with the soft key labels located immediately above. The labels of the soft keys change according to the current operating mode. For the equipment configured with AED, manual defibrillation and ECG monitoring functions, there are five soft keys. For the equipment configured with only AED function, there are three soft keys.
5.
Shock button Press this button to deliver a shock to the patient.
6.
Handle
7.
Power ON/OFF button Press this button to turn on or off this equipment.
8.
Optical sensor When [Brightness] is set to [Auto], the equipment automatically adjust the screen brightness according to the ambient light.
9.
Microphone While operating in AED mode, if [Voice Recording] is set to [On], the equipment provides voice recording. When [Voice Volume] is set to [Auto], the equipment automatically adjust the volume according to the ambient noise.
2.3.2
Side View
3
1
4
2
1.
Speaker
2.
USB connector
3.
CPR sensor connector (for the equipment configured with the CPR sensor)
4.
ECG cable connector (for the equipment configured with AED, manual defibrillation and ECG monitoring functions)
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2.3.3
Rear View
1
2
3
1.
Pads compartment
2.
Battery compartment
3.
Release button Press down this button and slide the battery door to the right to open the battery compartment.
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BeneHeart D1 Automated External Defibrillator Operator’s Manual
2.4
Display Views For the equipment configured with AED manual defibrillation and ECG monitoring functions 1
2
3
4
5
6
8
7
9
10
11
For the equipment configured with only AED function 1
2
3
4
5
6
7
10
11
1.
2.
Alarm status symbols ◆
indicates alarms are paused.
◆
indicates alarm sounds are turned off.
Alarm area This area shows alarm messages. When multiple alarms occur, they will be displayed circularly.
3.
Number of delivered shocks
4.
Runtime area This area shows the equipment's operating time since it is turned on.
5.
Patient type
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