Mindray BeneHeart D1 Operator's Manual
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Mindray BeneHeart D1 Operator's Manual

Automated external defibrillator
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BeneHeart D1
Automated External Defibrillator
Operator's Manual

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  • Page 1 BeneHeart D1 Automated External Defibrillator Operator’s Manual...
  • Page 3 © 2013-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is 2014-01.
  • Page 4 Mindray is strictly forbidden. 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.
  • Page 5 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.
  • Page 6 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.
  • Page 7 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.
  • Page 8 FOR YOUR NOTES...

  • Page 9: Table Of Contents

    Contents 1 Safety .................................... 1-1 1.1 Safety Information ......................................1-1 1.1.1 Dangers ........................................1-1 1.1.2 Warnings ......................................... 1-2 1.1.3 Cautions ........................................1-3 1.1.4 Notes ........................................1-3 1.2 Equipment Symbols ......................................1-4 2 The Basics ..................................2-1 2.1 Overview ..........................................2-1 2.2 Intended Use .........................................
  • Page 10 4.4.1 Changing the Alarm Volume ................................4-3 4.4.2 Pausing Alarm Sounds ..................................4-3 4.4.3 Switching Off Alarm Sounds ................................4-3 4.5 Reminder Tones ........................................4-4 4.6 Clearing Technical Alarms ....................................4-4 4.7 When an Alarm Occurs ...................................... 4-4 5 AED ....................................5-1 5.1 Overview ..........................................
  • Page 11 8 Data Management ............................... 8-1 8.1 Introduction .......................................... 8-1 8.2 Recommended USB Flash Memory ................................8-1 8.3 Exporting Data ........................................8-2 9 Configuration Management ............................9-1 9.1 Introduction .......................................... 9-1 9.2 Viewing System Configuration ..................................9-1 9.3 Password ..........................................9-1 9.4 Accessing Configuration Management ...............................
  • Page 12 A.6 Data Management Specifications ................................A-7 A.7 Wireless Network ........................................ A-7 A.8 Environmental Specifications ..................................A-7 B EMC ....................................B-1 C BeneHeart D1 User Checklist ............................C-1 D Prompt Messages ................................ D-1 E Electrical Safety Inspection............................E-1 E.1 Power Cord Plug ........................................E-1 E.2 Device Enclosure and Accessories ................................

  • Page 13: Safety

    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 ...

  • Page 14: Warnings

    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. ...

  • Page 15: Cautions

    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.

  • Page 16: Equipment Symbols

    1.2 Equipment Symbols Caution (Attention, consult Stand-by accompanying documents) Shock button USB connector Serial number Date of manufacture Unlocking Open the battery door as indicated General symbol for Operating instructions recovery/recyclable Do not expose the battery to high heat or open flames. Do not Do not crush the battery.

  • Page 17: The Basics

    2.1 Overview The BeneHeart D1 (hereinafter called the equipment) is a lightweight and portable automated external defibrillator. There are two types of configuration for the equipment: Pro and Public. Public provides only AED mode while Pro provides two operating modes: AED and Manual Defib mode.

  • Page 18: Aed

    2.2.1 AED The AED mode is to be used only on cardio arrest patients who must be:  Unresponsive  Not breathing or not breathing normally 2.2.2 Manual Defibrillation Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive.

  • Page 19: Side View

    Status indicator Green: All the tests are passed, and the equipment operates properly. Red: Failure is detected on the equipment. Display screen 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.

  • Page 20: Rear View

    2.3.3 Rear View Pads compartment Battery compartment Release button Press down this button and slide the battery door to the right to open the battery compartment.

  • Page 21: Display Views

    2.4 Display Views For Pro For Public Alarm status symbols  indicates alarm sounds are paused;  indicates alarm sounds are turned off. Alarm area This area shows alarm messages. When multiple alarms occur, they will be displayed circularly.

  • Page 22: Soft Key Symbols

    Number of delivered shocks Runtime area This area shows the equipment's operating time since it is turned on. Patient type Record icon It is displayed if the sounding recording function is enabled. Battery Status indicator It indicates battery status. Refer to 10 Battery for details. Heart rate Waveform area This area shows the ECG waveforms.

  • Page 23: Basic Operations And Settings

    Basic Operations and Settings 3.1 Installation WARNING  The equipment shall be installed by personnel authorized by the manufacturer.  The software copyright of the equipment is solely owned by the manufacturer. No organization or individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.

  • Page 24: Environmental Requirements

    NOTE  Save the packing case and packaging material as they can be used if the equipment must be reshipped. 3.1.2 Environmental Requirements The operating environment of the equipment must meet the requirements specified in this manual. The environment where the equipment is used shall be reasonably free from noises, vibration, dust, corrosive, flammable and explosive substances.

  • Page 25: Basic Operations

    NOTE  Make sure the pads package is intact before use. Otherwise, replace it with a new one. 3.2 Basic Operations 3.2.1 Turning Power On Check for mechanical damages on the equipment or other damages on the pads package. Make sure the pads cable is properly connected and battery installed. Check the expiration date of the pads on the pads package.

  • Page 26: Turning Off The Equipment

    3.2.2.2 Selecting System Language In the [General Setup] menu, select [Language] to set the system language, which refers to the language of messages, menus, and audio prompts and so on. If the system language is set to a non-English language, you can also set [Bilingual Option] in the [General Setup] menu.

  • Page 27: Alarms

    Alarms Alarms, triggered by a vital sign that appears abnormal or by technical problems of the equipment, are indicated to the user by visual and audible alarm indications. WARNING  A potential hazard exists if different alarm presets are used for the same or similar device in any single area, e.g.

  • Page 28: Alarm Indicators

    4.3 Alarm Indicators When an alarm occurs, the equipment indicates it to the user through visual or audible alarm indications.  Alarm tones  Alarm message NOTE  When multiple alarms of different levels occur simultaneously, the equipment will select the alarm of the highest level and give visual and audible alarm indications accordingly.

  • Page 29: Alarm Tone Configuration

    4.4 Alarm Tone Configuration 4.4.1 Changing the Alarm Volume → [Config. → ] [Config. Edit → If the equipment is on, press the Power On/Off button and then select ] enter the required password → [Alarm]. Set [Alm Volume] to any of the following: ...

  • Page 30: Reminder Tones

    4.5 Reminder Tones When alarms or alarm sounds are turned off, the equipment can give a reminder tone of a single beep every 60 seconds. The reminder tone is switched off by default. You can switch it on by selecting [Alarm] → [Reminder Tone] in the [Config.

  • Page 31: Aed

    5.1 Overview This chapter describes how to operate the equipment in AED Mode. While operating in AED Mode, the equipment analyses the patient’s ECG waveforms and guides you through the defibrillation process. The equipment starts analyzing the patient’s heart rhythm immediately after entering AED mode. When a shockable rhythm is detected, the equipment gives a prompt and automatically starts charging.

  • Page 32: Aed View

    CAUTION  Aggressive handling of multifunction electrode pads in storage or prior to use can damage the pads. Discard the pads if they become damaged.  For patients with implantable pacemaker, the sensitivity and specificity of AED algorithm may be impaired.

  • Page 33: Aed Procedure

    5.4 AED Procedure Confirm that the patient is unresponsive, not breathing or not breathing normally. Then: Press the Power On/Off button to turn on the equipment. When the equipment enters AED mode, it checks to see if the pads and pads cable are properly connected. If not, prompt messages will appear in the AED information area until corrective action has been taken.

  • Page 34: Shock Advised

    NOTE  Use the defibrillator pads before the expiration date. If the pads are found expired, by checking either the expiration date on the pads package or the alarm message displayed on the screen, replace the pads immediately. In emergency, if there are no spare pads nearby, proceed patient treatment with the pads and ignore pads related alarm messages.

  • Page 35: No Shock Advised (Nsa)

    5.6 No Shock Advised (NSA) If a shockable rhythm is not detected, the equipment will tell you "No Shock Advised!".  If the [NSA Action] is set to [CPR]: the equipment enters CPR status.  If the [NSA Action] is set to [Monitor]: The equipment continues to monitor the ECG and automatically resumes analysis if a potentially shockable rhythm is detected.

  • Page 36: Aed Sound Recording

    5.8 AED Sound Recording The equipment includes a sound recording function that can record the voice information during AED therapy. The sound recording function can be configured on or off. To switch on or off the sounding recording, → [Config.] → [Config. Edit] → Enter the required password. Press the Power On/Off button and then select Select [General Setup →...

  • Page 37: Manual Defibrillation (For Pro Only)

    Manual Defibrillation (For Pro Only) 6.1 Overview Manual defibrillation is available only on Pro. This chapter explains how to prepare for and perform asynchronous defibrillation and synchronous cardioversion using multifunction electrode pads. In Manual Defibrillation Mode, you must assess the ECG waveforms, decide if defibrillation or cardioversion is indicated, select appropriate energy setting, charge the equipment, and deliver the shock.

  • Page 38: Manual Defibrillation View

    CAUTION  Prior to using this defibrillator, disconnect from the patient all equipment that is not defibrillator-protected. NOTE  Impedance is the resistance between the defibrillator’s pads that the defibrillator must overcome to deliver an effective discharge of energy. The degree of impedance differs from patient to patient and is affected by several factors including the presence of chest hair, moisture, and lotions or powders on the skin.

  • Page 39: Manual Defibrillation Procedure

     Press [Enter Sync] soft key to enter synchronous cardioversion mode.  Press soft key to change patient type.  Press [Silence] to temporarily pause the current alarm sound. This soft key is not displayed if there is no alarm sound currently.

  • Page 40: Synchronized Cardioversion

    6.5 Synchronized Cardioversion Synchronized Cardioversion allows you to synchronize delivery of the defibrillator shock with the R-wave of the ECG. To use synchronized cardioversion, press the [>>] and then [Enter Sync] soft keys in the Manual Defib mode. Then “Sync” appears in the Defibrillation information area and a marker appears above each R-wave, see the figure below: You can monitor ECG through multifunction electric pads or electrodes connected to a 3-lead ECG cable.

  • Page 41: Delivering Additional Synchronized Shocks

    NOTE  Once the equipment enters Synchronized Cardioversion mode, the alarms resume.  During synchronized cardioversion, it is important to continue to hold the shock button until the shock is delivered. The equipment shocks with the next detected R-wave.  If no R-wave is detected within 9s, a prompt message "'No R-Wave"...
  • Page 42 FOR YOUR NOTES...

  • Page 43: Monitoring Ecg (For Pro Only)

    Monitoring ECG (For Pro Only) 7.1 Overview The electrocardiogram (ECG) measures the electrical activity of the heart and displays it as waveforms and numerics. The equipment enables ECG monitoring through 3-lead ECG sets and multifunction electrode pads. If both ECG sets and pads are connected, the configured ECG waveform is displayed in the waveform area.

  • Page 44: Ecg View

    7.3 ECG View HR value Gain Heartbeat icon Lead ECG monitoring is provided after startup in both AED and Manual Defibrillation mode. The equipment displays one ECG waveform and the heart rate reading. If the patient is properly connected to the equipment, a dash line is shown in the ECG waveform area. 7.4 Preparing to Monitor ECG 7.4.1 ECG Monitoring with Electrodes Prepare the patient’s skin.

  • Page 45: Ecg Monitoring With Pads

    Electrode Placement for Surgical Patients The surgical site should be taken into consideration when placing electrodes on a surgical patient, e.g. for open-chest surgery, the chest electrodes can be placed on the lateral chest or back. To reduce artifacts and interference from electrosurgical units, you can place the limb electrodes close to the shoulders and lower abdomen and the chest electrodes on the left side of the mid-chest.

  • Page 46: Changing Ecg Settings

    Pads Placement for Pediatric Patient Place the pink pad in the center of the chest between the nipples, and the yellow one in the center of the back (anterior-posterior), as shown below: 7.5 Changing ECG Settings 7.5.1 Selecting Lead Type In Manual Defibrillation mode, select [>>] and then press [Lead] repeatedly to set lead type as per the adopted lead type.

  • Page 47: Arrhythmia Analysis

    7.6 Arrhythmia Analysis Arrhythmia analysis provides information about your patient’s condition, including heart rate and arrhythmia alarms. In the process of ECG monitoring, if any arrhythmia event is detected, corresponding arrhythmia alarms are reported according to the alarm level. NOTE ...

  • Page 48: Setting Arrhythmia Analysis

    Arrhythmia event Description Category Nonsus. Vtac The consecutive PVCs < the Vtac PVCs limit but > 2, and HR ≥ the Vtac Rate limit. Irr. Rhythm Consistently irregular rhythm.  When multifunctional electrode pads are used for ECG monitoring, the equipment provides only asystole and shockable rhythm alarms.

  • Page 49: Automatic Arrhythmia Relearn

    7.6.4 Automatic Arrhythmia Relearn Arrhythmia relearning is initiated automatically whenever:  The ECG lead or lead label is changed  The ECG lead is re-connected  Patient category is changed  The paced status is changed,  Arrhythmia analysis is switched on ...
  • Page 50 FOR YOUR NOTES...

  • Page 51: Data Management

    Data Management 8.1 Introduction Once turned on, the equipment automatically generates a patient ID and starts to record the following information for the current patient:  Trends,  Waveforms,  Events; and,  Audio recording of the rescuing process (for up to three hours). Along with the above patient data, some device information is also exported, including intellectual property statement, device ID, software version, hardware version, work status, and battery information.

  • Page 52: Exporting Data

    8.3 Exporting Data Plug a USB flash memory to the USB connector on the equipment. Press the Power On/Off button, and then select to enter the maintenance mode. Select the [Archive] soft key, and press to toggle among the data to be exported, and then to confirm the selection.

  • Page 53: Configuration Management

    Configuration Management 9.1 Introduction Configurations management enables you to customize you equipment to best meet your needs. With this function, you can:  View system configuration;  Change system configuration;  Restore the factory default configuration; and,  Export or import configuration files. After the system configurations have been changed, the new configuration settings take effect immediately.

  • Page 54: Restoring Factory Default Configuration

    On the [Config. Edit] screen, you can:  Press to toggle among setting items or options; and,  Press to confirm the selection or to return to the previous menu. NOTE  Changing of setup items shall be performed under the direction of authorized personnel. 9.5 Restoring Factory Default Configuration On the [Config.

  • Page 55: Aed Setup Menu

    Menu Item Options/Range Default Remark Three languages are available on your ENGLISH, SIM. CHINESE, FRENCH, equipment, CHINESE, ENGLISH, and your GERMAN, ITALIAN, SPANISH, Language local language. For English or Chinese PORTUGUESE, RUSSIAN, CZECH, speaking countries, the default language DUTCH, CROATIA options are CHINESE, ENGLISH, and FRENCH.

  • Page 56: Cpr Setup Menu

    9.6.4 CPR Setup Menu Menu Item Options/Range Default CPR Mode 30:2, 15:2, Hands-Only 30:2 9.6.5 ECG Setup Menu (For Pro Only) Menu Item Options/Range Default ECG Bandwidth Monitor, Therapy Therapy Arrhythmia Lethal Arrh. Only, All Lethal Arrh. Only Asystole Delay 3 to 10 Adult 60 to 300...

  • Page 57: Network Setup Menu

    9.6.8 Network Setup Menu Menu Item Options/Range Default Remark IP Address Input static IP address 4 segments, and editable range 0 to 255 Subnet Mask for each Gateway Access Point 0 to 9, a to z, A to Z Password Device Management System 4 segments, and editable range 0 to 255 Input the IP address of Device...
  • Page 58 FOR YOUR NOTES...

  • Page 59: Battery

     Keep the batteries out of children’s reach.  Use only specified batteries.  The batteries should only be charged in Mindray BatteryFeed20 charger station.  Never charge the disposable battery in any case. NOTE  Remote upgrade might take a long time and greatly reduce the charge of the installed battery. Please check the battery status after each upgrade.

  • Page 60: Battery Alarms

    10.2 Battery Alarms 10.2.1 Low Battery Alarm If the battery charge is low, a technical alarm “Low Battery” will be triggered. In this case, replace the battery with a fully charged rechargeable battery or a new disposable battery on immediately. If the battery is almost depleted, a prompt “Battery Depleted! Replace Battery Now.

  • Page 61: Replacing Batteries

    10.4 Charging Batteries The rechargeable batteries can be charged only using Mindray BatteryFeed20 charger station. At a temperature of 25°C (77 °F), a completely discharged battery charges to 90% of its capacity in approximately 2.5 hours, and to 100% of its capacity in approximately 3 hours.

  • Page 62: Storing Batteries

    10.5 Storing Batteries When storing batteries, make sure that the battery terminals do not come into contact with metallic objects. If batteries are stored for an extended period of time, they should be placed in a cool place with a partial charge of 40% to 60% capacity (3 LEDs illuminated for rechargeable batteries).

  • Page 63: Care And Cleaning

    Care and Cleaning Use only the substances approved by the equipment manufacturer and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damages caused by unapproved cleaning and disinfection substances or methods. We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. For the method to control infection, consult your hospital’s infection control officer or epidemiologist.

  • Page 64: Cleaning

    11.2 Cleaning Your equipment should be cleaned on a regular basis. If there is heavy pollution or lots of dust and sand in your place, the equipment should be cleaned more frequently. Before cleaning the equipment, consult your hospital’s regulations for cleaning the equipment.

  • Page 65: Maintenance And Testing

    Maintenance and Testing WARNING  Failure for the responsible individual, hospital or institution employing this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.  The safety checks or maintenance involving any disassembly of the equipment should be performed by professional servicing personnel.

  • Page 66: Overview

    12.1 Overview To ensure that the equipment is ready for operation at any time, the following tests or inspections should be performed:  Routine check  Automatic test  User test  Electrical safety tests. In case of any damage or abnormity, remove the equipment from use. Contact the hospital’s biomedical engineers or your service personnel immediately.

  • Page 67: Power-On Test

    12.3.1 Power-On Test Each time you turn the equipment on, the welcome screen is displayed, and the equipment starts power-on test immediately. If a failure is detected, related failure information is displayed. 12.3.2 Real-Time Test Real-time test persists throughout the runtime of the equipment. If any failure is detected, corresponding alarm is reported.

  • Page 68: User Test

    12.3.5 User Test WARNING  Do not perform user test when a patient is connected to the equipment. On the maintenance screen, you can press [User Test] to perform user test. You need to: Press the corresponding soft keys and Shock button as indicated on the screen. Select an option to respond to the equipment if you have heard the voice prompt.

  • Page 69: Troubleshooting

    Troubleshooting 13.1 General Problems NOTE  Never try to disassemble the equipment or supplied accessories. There are no internal user-serviceable parts. This chapter lists the problems that are likely to occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting for services.

  • Page 70: Alarm Messages

    13.2 Alarm Messages This chapter lists only the most important physiological and technical alarm messages. Some messages appearing on your equipment may not be included. In the “Cause and solution” column, corresponding solutions are given instructing you to troubleshoot problems. If the problem persists, contact your service personnel.

  • Page 71: Technical Alarm Messages

    13.2.2 Technical Alarm Messages In this chapter, the “I” column indicates how indications of technological alarms are cleared after the [Silence] softkey is pressed: “A” means all alarm indications are cleared; and “B” indicates only alarm tone is disabled, but other indications remain presented.
  • Page 72 Source Alarm Message Alarm Level Cause and solution Pads Abnormal The type of pads is recognized, but the one-wire communication failed. Re-plug the pads. If the problem persists, call for service. Pads Expires The pads have expired. Replace the pads. Pads expiring soon The pads are expiring soon.

  • Page 73: Accessories

    Accessories WARNING  Use accessories specified in this chapter. Using other accessories may cause damage to the equipment or not meet the claimed specifications.  Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.

  • Page 74: Therapy Accessories

    14.2 Therapy Accessories Description Model Applicable patient Remark Multifunction MR60 Adult 0651-30-77007 Disposable (5 sets/pack) electrode pads MR61 Pediatric 0651-30-77008 14.3 Miscellaneous Description Model Rechargeable lithium ion battery LI24I001A 022-000047-00 Disposable battery LM34S001A 022-000124-00 Charger Station kit (with international power cord) 115-009187-00 Charger Station kit (with US power cord) 115-009188-00...

  • Page 75: A Specifications

    Specifications Items marked with “*” symbol are available for Pro only. A.1 General Specifications Type of protection against Equipment energized from an internal electrical power source (battery). electrical shock Type BF defibrillation proof for external defibrillation. Degree of protection against electric shock Type CF defibrillation proof for ECG* Mode of operation...

  • Page 76: Defibrillator Specifications

    A.2 Defibrillator Specifications Defibrillation mode Manual Defib, synchronous cardioversion, AED Biphasic truncated exponential (BTE) waveform, auto-compensation according to patient Defibrillation waveform impedance Defibrillation electrodes Multifunction electrode pads Range of selected energy External defibrillation 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 50, 70, 100, 150, 170, 200, 300, 360 J Patient impedance range External defibrillation 25 to 200 Ω...
  • Page 77 Selected energy accuracy Impedance 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 175Ω Accuracy Energy ±2J ±2J ±2J ±2J ±2J ±2J ±2J ±2J ±2J 10 J ±2J 15 J ±15% 20 J ±15% 30 J ±15% 50 J ±15% 70 J ±15% 100 J ±15% 150 J...

  • Page 78: Monitor Specifications

    Energy level: 100 to 360J, configurable; Shock series Shocks: 1, 2, 3, configurable; Meeting AHA guidelines 2010 by default. Shockable rhythm VF, VT (HR>150bpm and QRS width>120ms) AED ECG Analysis Performance Rhythm Class Performance requirement Remark Shockable rhythm Sensitivity > 90% Meets IEC 60601-2-4 and AAMI DF80 Ventricular fibrillation requirement and AHA recommendation...
  • Page 79 Electrode offset potential tolerance ±1 V Pediatric 15 to 350 bpm HR measurement range Adult 15 to 300 bpm HR accuracy ±1% or ±1bpm, which ever is greater HR resolution 1 bpm Measuring electrode: <0.1 μA Lead-off detection current Drive electrode: <1 μA Baseline recovery time <5 s (after defibrillation) When the test is performed based on part 4.1.2.1 c) of ANSI/AAMI EC 13-2002,...

  • Page 80: Power Supply Specifications

    Pace Pulse Pace pulses meeting the following conditions are labelled with a PACE marker: Amplitude: ±2 to ±700 mV Pace pulse markers Width: 0.1 to 2 ms Rise time: 10 to 100 μs Meets the requirements of ANSI/AAMI EC13-2002: section 4.1.4.1 and 4.1.4.3. The following pulses will be rejected.

  • Page 81: Alarm Specifications

    A.5 Alarm Specifications Alarm levels High, medium, low level alarms, complying with IEC 60601-1-8 Alarm categories Physiological alarms, technical alarms Parameter alarm setting ECG alarm properties can be set in the [ECG Setup] menu Auto alarm limits Parameter alarm limits can be automatically adjusted according to currently measured vital signs A.6 Data Management Specifications Data storage Inner flash memory, 512 M Bytes...
  • Page 82 Shock Complies with requirements of 21.102, ISO9919: Peak acceleration: 1000m/s2 (102g) Duration: 6ms Pulse shape: half-sine Number of shocks: 3 shocks per direction per axis (18 total) Vibration Complies with requirements of 21.102, ISO9919. Bump Complies with the requirements of 6.3.4.2, EN1789. Peak acceleration: 15g Duration: 6ms Number of impacts: 1000...
  • Page 83 The equipment meets the requirements of IEC 60601-1-2. NOTE  Use of accessories, transducers, and cables other than those specified may result in increased emission and/or decreased electromagnetic immunity of the defibrillator/monitor.  The equipment or its components should not be used adjacent to or stacked with other devices. If adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used.
  • Page 84 Guidance and Declaration - Electromagnetic Immunity The equipment is suitable for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. IEC 60601 Immunity test Test level Compliance level Electromagnetic environment - guidance...
  • Page 85 Rated Maximum Separation Distance According to Frequency of Transmitter (m) Output power of 150 kHz to 80 MHz 150 kHz to 80 MHz in 80 MHz to 800 MHz 800 MHz to 2.5 GHz Transmitter Watts outside ISM bands ISM bands ...
  • Page 86 FOR YOUR NOTES...

  • Page 87: C Beneheart D1 User Checklist

    BeneHeart D1 User Checklist Inspect the equipment as recommended. Place a “√” in the “Pass/Fail” box as you check the item , or place a “-” if not applicable. Describe the problem if there is any abnormity. Equipment Name: Serial Number:...
  • Page 88 FOR YOUR NOTES...

  • Page 89: D Prompt Messages

    Prompt Messages This chapter lists the prompt audio and text messages that might appear on your equipment. Source Message Audio System Battery Depleted! Replace Battery Now. Battery Depleted! Replace Battery Now. Adult mode. Pediatric mode. Remove Clothing Remove clothing from patient’s chest. Take Out Pads Package Take out pads package from back of AED.
  • Page 90 Source Message Audio Follow the Metronome to Compress Follow the Metronome to Compress Give 2 Breaths Give two Breaths Breathe Breathe Continue Continue Stop CPR Stop CPR Stop Now Stop Now Manual Adult mode. Defibrillation Pediatric mode. Plug in Pads Connector Apply Pads Charging to %s J Energy Changed.
  • Page 91 Source Message Audio Test Passed. AED is Ready for Use. Test Failed. Call for Service. Service Code: Pads Missing. Unknown Pads Pads Abnormal, Replace Pads Advised Pads Expires, Replace Pads Advised Replace Battery Advised. Service Code: Please Perform User Test to Confirm. Replace Battery Advised.
  • Page 92 FOR YOUR NOTES...

  • Page 93: E Electrical Safety Inspection

    Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations. All tests can be performed by using commercially available safety analyzer test equipment.

  • Page 94: Device Labelling

    E.3 Device Labelling Check the labels provided by the manufacturer or the healthcare facilities are present and legible.  Main unit label  Integrated warning labels E.4 Patient Leakage Current Patient leakage currents are measured between a selected applied part and mains earth. All measurements have a true RMS only The following outlet conditions apply when performing the Patient Leakage Current test.

  • Page 95: Patient Auxiliary Current

    LIMITS  For CF applied parts: 50 μA  For BF applied parts: 5000 μA E.6 Patient Auxiliary Current Patient Auxiliary currents are measured between any selected Applied Part connector and the remaining Applied Part connector s. All measurements may have a true RMS only response. The following outlet conditions apply when performing the Patient Auxiliary Current test.
  • Page 96 FOR YOUR NOTES...

  • Page 97: F Symbols And Abbreviations

    Symbols and Abbreviations F.1 Units μA microampere μV microvolt ampere ampere hour beat per minute bit per second ºC centigrade centimeter decibel ºF fahrenheit hour hertz inch Joule kilogram kilopascal litre meter minute millimeter millisecond millivolt milliwatt breaths per minute second volt Ω...

  • Page 98: Symbols

    F.2 Symbols negative, minus – percent per; divide; or plus equal to < less than > greater than ≤ less than or equal to ≥ greater than or equal to plus or minus ± × multiply © copyright F.3 Abbreviations and Acronyms AAMI Association for Advancement of Medical Instrumentation adult...
  • Page 99 light emitting diode left leg magnetic resonance imaging neonate oxygen pediatric pacer not captured pacer not paced premature ventricular complex right arm record, recording right leg Sync synchronization universal serial bus...
  • Page 100 FOR YOUR NOTES...

  • Page 101: G Device Tracking

    In order to provide high quality product and perform better service, we are going to track our product. Please contact us with the device tracking information when you have received your defibrillator/monitor: Please fill the information in the next page, cut the table and fax it to +86 755 26582934. You can also email your information to service@mindray.com.
  • Page 102 FOR YOUR NOTES...
  • Page 106 P/N: 046-004673-00 (3.0)

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