Mindray BeneHeart D60 Instructions For Use Manual
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Mindray BeneHeart D60 Instructions For Use Manual

Defibrillator/monitor
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BeneHeart D60/BeneHeart D50A
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Defibrillator/Monitor
Instructions for Use

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Summary of Contents for Mindray BeneHeart D60

  • Page 1 BeneHeart D60/BeneHeart D50A BeneHeart D50/BeneHeart D50C Defibrillator/Monitor Instructions for Use...
  • Page 3 2797 © Copyright 2022 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. Release time: June 2022 Revision: 1.0...

  • Page 4: 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.

  • Page 5: Warranty

    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 6: Notification Of Adverse Events

    Notification of Adverse Events As a health care provider, you may report the occurrence of certain events to SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority of the Member state in which the user and / or patient is established.

  • Page 7: 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 - 1 1.1.3 Cautions ........................................1 - 2 1.1.4 Notes .........................................1 - 3 2 Equipment Overview ................................ 2 - 1 2.1 Intended Use ........................................2 - 1 2.1.1 Intended Purpose Statement ................................2 - 1 2.1.2 Indication for Use ....................................2 - 1...
  • Page 8 7.2 CPR Metronome .........................................7 - 1 7.2.1 Viewing Filtered ECG Waveform ..............................7 - 1 7.3 CPR Feedbacks ........................................7 - 2 7.4 CPR Quality (CQI) Monitoring ..................................7 - 2 8 Noninvasive Pacing ................................8 - 1 8.1 Pacing Safety Information ....................................8 - 1 8.2 Choosing the Pacer Mode Setting ................................8 - 2 8.2.1 Demand Mode Pacing Procedure ..............................8 - 2 8.2.2 Fixed Mode Pacing Procedure ................................8 - 2...
  • Page 9 11.5.1 Arrhythmia Safety Information ..............................11 - 3 11.5.2 Changing Arrhythmia Settings ..............................11 - 4 11.6 ST Segment Monitoring ....................................11 - 5 11.6.1 ST Safety Information ..................................11 - 5 11.6.2 Saving the Current ST as Baseline ............................. 11 - 5 11.7 QT/QTc Interval Monitoring ..................................
  • Page 10 17 Monitoring Invasive Blood Pressure (IBP) ........................17 - 1 17.1 IBP Safety Information ....................................17 - 1 17.1.1 Measuring an IBP .................................... 17 - 1 17.2 Measuring ICP Using the Codman ICP Transducer ........................... 17 - 1 17.3 IBP Display ........................................17 - 1 17.4 Changing IBP Settings ....................................
  • Page 11 24.1 Configuration Management Introduction ............................24 - 1 24.2 Changing Configurations ................................... 24 - 1 25 Battery ....................................25 - 1 25.1 Battery Safety Information ..................................25 - 1 25.2 Battery Indications ......................................25 - 1 25.3 Conditioning the Battery .................................... 25 - 1 25.4 Checking Battery Performance ................................
  • Page 12 A.7.1 Defibrillation Specifications ................................A - 11 A.7.2 CPR Compression Specifications ..............................A - 13 A.7.3 Pacer Specifications ..................................A - 13 A.8 Monitor Specifications ....................................A - 14 A.8.1 ECG Specifications (from ECG Accessories) ..........................A - 14 A.8.2 ECG Specifications (from Therapy Accessories) ........................A - 16 A.8.3 Resp Specifications ..................................A - 18 A.8.4 SpO Specifications ..................................A - 18...

  • Page 13: Safety

    Safety 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: Cautions

    • The software equipment copyright is solely owned by Mindray. No organization or individual shall resort to modifying, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.

  • Page 15: Notes

    • 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. If you have any questions concerning disposal of the equipment, please contact us. •...
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  • Page 17: Equipment Overview

    Equipment Overview Intended Use 2.1.1 Intended Purpose Statement The equipment is intended for external defibrillation, internal defibrillation, synchronized cardioversion and semi-automated defibrillation (AED). It can also be used for non-invasive external pacing, CPR feedback, CPR filter, ECG resting analysis as well as ECG, Resp, SpO , PR, NIBP, IBP, Temp and CO monitoring.

  • Page 18: Contra-Indications

    2.1.6 Contra-indications ■ The AED mode is contraindicated in the treatment when the patient is showing any of the following: ◆ Consciousness ◆ Breathing ◆ Detectable pulse or other signs of circulation ■ Manual Defibrillation Manual defibrillation is contraindicated in the treatment when the patient is showing any of the following: ◆...

  • Page 19: Equipment Preparation

    Any personnel who connect devices to the equipment’s signal input/output port are responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1. If you have any questions, please contact Mindray. •...

  • Page 20: Turning On The Equipment

    • Do not use the equipment on a patient if you suspect it is not working properly, or if it is mechanically damaged. Contact the service personnel or Mindray. • Check that visual and auditory alarm signals are presented correctly when the equipment is turned...

  • Page 21: Turning Off The Equipment

    Turning Off the Equipment CAUTION • Press and hold the power switch for 10s to forcibly shut down the equipment if it could not be shut down normally. This may cause loss of patient data. NOTE • To prevent the changes from losing in case of sudden power failure, the equipment saves the settings in real time.
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  • Page 23: Therapy Preparation

    Therapy Preparation Checking the Patient Contact Indicator NOTE • It is recommended to perform the defibrillation on a patient when the patient contact indicator illuminates in green. If the patient contact indicator illuminates in orange, it also can be used for the defibrillation.
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  • Page 25: Aed

    AED Safety Information DANGER • Defibrillation current can cause operator or bystander severe injury or even death. Do not touch the patient or any metal objects (including bed or gurney) connected to the patient during defibrillation. • Avoid contact between parts of the patient’s body such as exposed skin of head or limbs, conductive fluids such as gel, blood, or saline, and metal objects such as a bed frame or a stretcher which may provide unwanted pathways for the defibrillating current.

  • Page 26: Aed Procedure

    AED Procedure NOTE • Anterior - lateral placement for adult patients, and anterior-posterior placement for pediatric patients are recommended placements for defibrillation with electrode pads. • For defibrillation of pediatric patients under 8 years, pediatric electrode pads should be used. •...

  • Page 27: Manual Defibrillation

    Manual Defibrillation Manual Defibrillation Safety Information DANGER • Defibrillation current can cause operator or bystander severe injury or even death. Do not touch the patient or any metal objects (including bed or gurney) connected to the patient during defibrillation. • Avoid contact between parts of the patient’s body such as exposed skin of head or limbs, conductive fluids such as gel, blood, or saline, and metal objects such as a bed frame or a stretcher which may provide unwanted pathways for the defibrillating current.

  • Page 28: External Defibrillation Procedure

    • Successful resuscitation is dependent on many variables specific to the patient’s physiological state and the circumstances surrounding the patient event. Failure to have a successful patient outcome is not a reliable indicator of equipment performance. The presence or absence of a muscular response to the transfer of energy during electrical therapy is not a reliable indicator of energy delivery or equipment performance.

  • Page 29: Synchronized Cardioversion Procedure

    6.4.1 Synchronized Cardioversion Procedure NOTE • During synchronized cardioversion, the shock will be delivered when the equipment detects the next R-wave. If electrode electrodes or internal paddles without button are used, you should press and hold the Shock button on the equipment until the shock is delivered. If external paddles are used, you should press and hold the Shock buttons on both the external paddles until the shock is delivered.
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  • Page 31: Cpr Assistance

    CPR Assistance CPR Assistance Safety Information WARNING • Perform CPR on a patient on firm ground if possible. When you perform CPR on a patient lying on a mattress, a backboard must be used to limit the amount of compressed depth which is absorbed by the mattress.

  • Page 32: Cpr Feedbacks

    CPR Feedbacks NOTE • When the interruption time exceeds five minutes, a CPR event is automatically generated. CPR Quality (CQI) Monitoring WARNING • CQI monitoring is not intended for pediatric and neonatal patients. • CQI results should not be used as the sole basis for diagnosis or therapy decisions. It is not intended to replace the competent judgment of a clinician.

  • Page 33: Noninvasive Pacing

    Noninvasive Pacing Pacing Safety Information WARNING • Heart rate and related alarms may be unreliable during pacing, you should always keep the patient under close survillance. The indicated heart rate or related alarms cannot be used as the sole basis for the patient’s perfusion status.

  • Page 34: Choosing The Pacer Mode Setting

    Choosing the Pacer Mode Setting NOTE • Use the demand mode pacing whenever possible. Only use the fixed mode pacing when there are interferes causing R-wave unreliable or no available ECG electrodes. 8.2.1 Demand Mode Pacing Procedure CAUTION • Routinely assess the patient’s cardiac output. NOTE •...

  • Page 35: Monitoring Preparation

    Monitoring Preparation Defining the Monitoring Display 9.1.1 Setting the Switch for a Parameter NOTE • When a parameter is manually switched off, you cannot monitor this parameter even if related accessories are connected. 9.1.2 Defining the Normal Screen Display NOTE •...
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  • Page 37: Alarms

    Alarms 10.1 Alarm Introduction NOTE • When multiple alarms of different priority levels occur simultaneously, the equipment selects the alarm of the highest priority to light the alarm lamp and issue the alarm tone. • When multiple alarms of different priority levels occur simultaneously and should be displayed in the same area, the equipment only displays the messages of the highest priority alarm.

  • Page 38: Setting Alarm Tone Properties

    10.2.1 Setting Alarm Tone Properties NOTE • When the alarm volume is set to 0, the alarm sound is turned off and the audio off symbol is displayed in the alarm status area. • You cannot set the volume of high priority alarms if Alarm Volume is set to 0. 10.2.2 Setting the Switch of SpO Desat Alarm Off...

  • Page 39: Switching Off Alarm Sounds

    10.6 Switching Off Alarm Sounds WARNING • Switching off alarm sounds may result in a hazard to the patient. 10.7 Resetting Alarms NOTE • If a new alarm is triggered after the alarm system is reset, the alarm reset symbol will disappear, indications of the alarm lamp, alarm tone and alarm messages will be reactivated.
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  • Page 41: Monitoring Ecg

    Monitoring ECG 11.1 ECG Safety Information WARNING • ECG monitoring provided by this equipment is not intended for direct cardiac application. • Make sure the conductive parts of electrodes and associated connectors, including the neutral electrode, do not contact any other conductive parts including earth. •...

  • Page 42: Applying Ecg Electrodes

    11.3.2 Applying ECG Electrodes NOTE • Store the electrodes at room temperature. • Only open the electrode package immediately prior to use. • Never mix patient electrode types or brands. This may lead to problem due to impedance mismatch. • When applying the electrodes, avoid bony area, obvious layers of fat, and major muscles.

  • Page 43: Changing Ecg Settings

    11.4 Changing ECG Settings 11.4.1 Setting the Analysis Mode NOTE • It is difficult for the equipment to differentiate an aberrantly conducted beat from a ventricular beat. An aberrantly conducted beat may be misclassified as a ventricular beat. In this case, choose the lead with a narrow R-wave for ECG1 and select Single Lead.

  • Page 44: Changing Arrhythmia Settings

    CAUTION • Since the arrhythmia detection algorithm sensitivity and specificity are less than 100%, sometimes there may be some false arrhythmias detected and also some true arrhythmia events may not be detected. This is especially true when the signal is noisy. •...

  • Page 45: St Segment Monitoring

    11.5.2.5 Setting Arrhythmia Refractory Periods NOTE • Refractory periods are only applicable to arrhythmias in the medium priority chains. • Refractory periods have no impact on Tachy, Brady, HR High, HR Low, A-Fib/A-Fib End, Irr Rhythm/Irr Rhythm End. 11.6 ST Segment Monitoring 11.6.1 ST Safety Information WARNING...

  • Page 46: Ecg Troubleshooting

    11.9 ECG Troubleshooting NOTE • For the physiological and technical alarm messages, see D Alarm Messages. 11 - 6...

  • Page 47: Resting 12-Lead Ecg Analysis

    Resting 12-Lead ECG Analysis 12.1 Resting 12-Lead ECG Analysis Introduction WARNING • Resting 12-lead ECG analysis provided by this equipment is not intended for direct cardiac application. 12.2 Changing 12-Lead ECG Settings NOTE • For patients under 16 years old, it is recommended to V3 Placement to V4R and place chest electrodes at V4R, V1, V2, V4, V5, V6.
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  • Page 49: Monitoring Respiration (Resp)

    Monitoring Respiration (Resp) 13.1 Resp Safety Information WARNING • When monitoring the patient’s respiration, do not use ESU-proof ECG cables. • If you do not set the detection level for the respiration correctly in manual detection mode, it may not be possible for the equipment to detect apnea. If you set the detection level too low, the equipment is more likely to detect cardiac activity, and to falsely interpret cardiac activity as respiratory activity in the case of apnea.

  • Page 50: Changing Resp Settings

    • For patients expand chests laterally (normally neonatal patients), to avoid negative intrathoracic pressure and optimize respiratory waveforms, respectively apply the electrodes in the right midaxillary and the left lateral chest areas at the maximum point of the breathing movement. •...

  • Page 51: Monitoring Pulse Oxygen Saturation (Spo )

    The SpO extension cable should be compatible with the SpO connectors. For example, you can only the Mindray SpO extension cable to the Mindray SpO connectors. • Measurement accuracy verification: The SpO accuracy has been verified in human experiments by comparing with arterial blood sample reference measured with a CO-oximeter.

  • Page 52: Spo Display

    Refer to the Cable or Sensor DFU for the specified duration of the patient monitoring time. 14.3 Display NOTE • PI is only available for Mindray SpO and Masimo SpO 14.4 Preparing for SpO Monitoring CAUTION •...

  • Page 53: Nellcor Sat-Seconds Alarm Management

    14.5.2 Nellcor Sat-Seconds Alarm Management NOTE • The SpO Too Low or SpO Too High alarm is presented in the case that SpO value violates the alarm limits for 3 times within one minute even if the setting of Sat-Seconds is not reached. 14.5.3 Setting SpO Sensitivity (for Masimo SpO...
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  • Page 55: Monitoring Noninvasive Blood Pressure (Nibp)

    Monitoring Noninvasive Blood Pressure (NIBP) 15.1 NIBP Introduction NOTE • Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method or an intra-arterial blood pressure measurement device, within the limits prescribed by the American National Standard: manual, electronic, or automated sphygmomanometers.

  • Page 56: Nibp Measurement Limitations

    15.3 NIBP Measurement Limitations NOTE • The effectiveness of the sphygmomanometer has not been established in pregnant, including pre- eclamptic patients. 15.4 NIBP Display NOTE • If NIBP measurement fails, “XX” is displayed; if NIBP measurement is not taken, “--” is displayed. •...

  • Page 57: Monitoring Temperature (Temp)

    Monitoring Temperature (Temp) 16.1 Temperature Troubleshooting NOTE • For the physiological and technical alarm messages, see D Alarm Messages. 16 - 1...
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  • Page 59: Monitoring Invasive Blood Pressure (Ibp)

    If equipment of different brands are used to zero the Codman ICP transducer, the zero reference values can be different. Use a Mindray equipment to Zero the Codman ICP transducer if you will take ICP measurement using a Mindray equipment. Otherwise the ICP measurement can be inaccurate.

  • Page 60: Changing Ibp Settings

    17.4 Changing IBP Settings NOTE • It is not allowed to select the same label for different pressures. 17.5 IBP Troubleshooting NOTE • For the physiological and technical alarm messages, see D Alarm Messages. 17 - 2...

  • Page 61: Monitoring Carbon Dioxide (Co )

    Monitoring Carbon Dioxide (CO 18.1 Safety Information WARNING • Route all tubing away from the patient’s throat to avoid strangulation. CAUTION • Remove the airway sample line from the patient’s airway while nebulized medications are being delivered. • EtCO values measured from the CO module may differ from those of from the blood gas analysis.

  • Page 62: Measuring Mainstream Co

    18.3 Measuring Mainstream CO WARNING • When measuring CO using the mainstream CO module on patients who are receiving or have recently received anesthetics, connect the gas outlet to the anesthesia machine or ventilator. This avoids exposing medical staff to anesthetics. NOTE •...

  • Page 63: Clinical Assistive Applications

    Clinical Assistive Applications 19.1 Glasgow Coma Scale (GCS) CAUTION • GCS is intended as an adjunct in patient assessment and must be used in conjunction with observation of clinical signs and symptoms. • GCS is not applied to patients that are sedated, muscularly relaxed, with artificial airway, drunk, or in status epilepsies.

  • Page 64: Heart Score

    19.3 HEART Score NOTE • A license is required for HEART score. 19.4 Traumatic Brain Injury (TBI) Assessment NOTE • A license is required for TBI assessment. 19 - 2...

  • Page 65: Review

    Review 20.1 Reviewing Events NOTE • A total loss of power has no impact on the events stored. • Alarms are saved as events and will be maintained if the equipment is powered down. The time of equipment power down is not recorded as an event and cannot be reviewed. •...
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  • Page 67: Printing

    Printing 21.1 Loading Paper CAUTION • Use only specified thermal paper. Otherwise, it may cause damage to the recorder’s printhead, the recorder may be unable to print, or poor print quality may result. • Never pull the recorder paper with force when a recording is in process. Otherwise, it may cause damage to the recorder.
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  • Page 69: Discharged Patient Management

    Discharged Patient Management 22.1 Generating Patient Data NOTE • Earlier stored data will be overwritten by later ones if the equipment capacity is reached. 22.2 Accessing the Discharged Patient Mode WARNING • Patient therapy and monitoring automatically end when you access the Discharged Patient mode. The equipment automatically restarts and takes effects changes after the Discharged Patient mode.
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  • Page 71: Data Communication

    Data Communication 23.1 Data Communication Safety Information CAUTION • Wireless network design, deployment, debugging, and maintenance should be executed by Mindray service personnel or authorized technicians. • Always deploy the wireless network according to local wireless regulations. • Using 5 GHz frequency band is recommended whenever possible. There are more interference sources in 2.4 GHz frequency band.
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  • Page 73: Configuration Management

    Configuration Management 24.1 Configuration Management Introduction WARNING • Accessing the Configuration mode is password protected. Patient therapy and monitoring automatically end when you access the Configuration mode. • The configurations must be changed by authorized personnel only. • Never connect the equipment with the patient when accessing the configuration management. 24.2 Changing Configurations NOTE...
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  • Page 75: Battery

    Battery 25.1 Battery Safety Information WARNING • Keep batteries out of children’s reach. • Use only specified battery. Use of a different battery may present a risk of fire or explosion. • Keep the batteries in their original package until you are ready to use them. •...

  • Page 76: Checking Battery Performance

    25.4 Checking Battery Performance NOTE • Life expectancy of a battery depends on how frequent and how long it is used. When properly used, the lithium-ion battery has a useful life of approximately two years. If improperly used, its life expectancy can be shorten.

  • Page 77: Care And Cleaning

    • Do not mix disinfecting solutions, as hazardous gases may result. • Mindray is not liable for the efficacy of the specified cleaners, disinfectants, or methods as a means for controlling infection. Refer to your hospital for infection controlling. •...

  • Page 78: Cleaning And Disinfecting The Accessories

    Never clean or disinfect the connectors and metal parts. • Use only Mindray approved cleaners and disinfectants and methods listed in this section to clean or disinfect the accessories. Warranty does not cover damage caused by unapproved substances or methods.

  • Page 79: Maintenance

    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. If you have any questions concerning disposal of the equipment, please contact Mindray. NOTE •...

  • Page 80: User Test

    test load, the prompt “Test load not connected with cable” is displayed when the auto test passes. This means that the equipment only passes the internal discharge test, but not pass the external discharge test connected with the test load. 27.2.2 User Test WARNING...

  • Page 81: A Specifications

    Specifications Safety Specifications A.1.1 Safety Classifications The equipment is classified, according to IEC 60601-1: Type of protection against electrical shock • Used together with mains supply, AC transport dock or AC power adapter: Class I • Used together with a DC transport dock: Class II Degree of protection against electrical Type BF defibrillation proof for CO monitoring and external defibrillation.
  • Page 82 Complies with requirements for medical devices of 6.3.4.2, EN1789 (10.1.3, IEC60601-1-12): Peak acceleration: 1000m/s (102g) Duration: 6ms Pulse shape: half-sine Number of shocks: 3 shocks per direction per axis (18 shocks in total) Bump Complies with the requirements for road ambulances of 6.3.4.2, EN1789. Peak acceleration: 15g Pulse duration: 6ms Number of bumps: 1000...

  • Page 83: Power Supply Specifications

    Power Supply Specifications A.2.1 External Power Supply Specifications AC power input Input voltage 100 to 240 VAC (-15%, +10%) Input current 1.8 to 0.8A Frequency 50/60Hz (±3Hz) DC power input Input voltage 18 VDC (±5%) Input current 7.2Amax AC power adapter and transport dock (with AC input) Input voltage 100 to 240 VAC (-15%, +10%) Input current...

  • Page 84: Charger Station Specifications

    Battery run time Operating One battery Two batteries Testing condition condition Monitor ≥6.5 h ≥13 h • New fully charged battery. mode • Ambient temperature of 20ºC±5 °C. • The equipment is configured with 3-/5-lead ECG, manual defibrillation, screen brightness set to the lowest level without printing.

  • Page 85: Physical Specifications

    DC power input Input voltage 12.4 to 30.3 VDC Input current 15.5 to 6.5A Physical Specifications Dimensions (W × D × H) • 275 mm×160 mm×280 mm (including the handle, excluding external paddles) • 275 mm×155 mm×280 mm (including the handle, configured without the paddle tray) Maximum weight •...

  • Page 86: External Connectors

    Beep Gives reminder tones Audio signal Alarm tone: ISO mode with frequency of 600 Hz QRS tone: short beep with frequency of 495 Hz Charge tone: long beep with frequency of 400 Hz to 533 Hz Charge done tone: double beeps with frequency of 440 Hz Key tone: short beep with frequency of 1000 Hz A.4.5 External Connectors...

  • Page 87: Data Storage

    Alarm delay time from the equipment to • For pre-hospital network: the alarm delay time measured at the other remote equipment equipment signal output connector: ≤10 s • For hospital network: the alarm delay time measured at the equipment signal output connector: ≤2s Alarm signal sound pressure level range 45 db(A) to 85 db(A) within a range of one meter Data Storage...

  • Page 88: Wi-Fi Specifications (Wlink As Station)

    Test conditions Meets the following conditions simultaneously: • One equipment supported by a single AP • Each equipment can communicate with the CMS. • The weakest strength of the AP signal where the equipment is located is not less than -65 dBm. •...

  • Page 89: Cellular Specifications

    System capacity, interference immunity Meets the following requirements: and network stability • The total delay of data transmission from the equipment to the CMS: ≤ 10 s. • The delay for the equipment related settings configured at the CMS to be effective: ≤...

  • Page 90: Bluetooth Specifications

    ■ Operating frequency 4G module (EU): ◆ LTE FDD: B1/B3/B7/B8/B20/B28A ◆ LTE TDD: B38/B40/B41 ◆ WCDMA: B1/B8 ◆ GSM: B3/B8 ■ 5G module: ◆ NR: n1/n2/n3/n5/n7/n8/n12/n20/n28/n38/n40/n41/n48/n66/ n71/n77/n78/n79 ◆ LTE-FDD: B1/B2/B3/B4/B5/B7/B8/B9/B12/B13/B14/B17/B18/ B19/B20/B25/B26/B28/B29/B30/B32/B66/B71 ◆ LTE-TDD: B34/B38/39/B40/B41/B42/B48 Standard/Modulation mode LTE, 5G Sub-6GHz Alarm delay time of network The message and alarm delay of network disconnection between the disconnection equipment and CMS: ≤...

  • Page 91: Nfc Specifications

    Shock series Energy level: 100 to 360J, configurable for adult; 10 to 100J, configurable for pediatric Shocks: 1, 2, 3, configurable; Meeting AHA/ERC guidelines 2015 by default AED ECG analysis performance Refer to C Mindray Shockable Rhythm Analysis Algorithm. A - 11...
  • Page 92 360 J defibrillation waveform into impedance of 25Ω, 50Ω, 75Ω, 100Ω, 125Ω, 150Ω, 175Ω Time (ms) Impedance Selected energy Accuracy 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 175Ω ±10% or ±2J, whichever is greater 10 J 15 J 20 J 25 J 30 J 50 J 70 J...

  • Page 93: Cpr Compression Specifications

    Manual Defib Charge time* From initial From initial From initiation From initial From initial power on power on (from of rhythm power on power on (from Power supply (from cold fast startup analysis to (from cold fast startup start) to charge mode) to charge charge done start) to charge...

  • Page 94: Monitor Specifications

    NOTE • When pacing rate is changed from 30ppm to 210ppm, the response time to pacing (HR rising from 30bpm to 210bpm) is less than 20s. Monitor Specifications A.8.1 ECG Specifications (from ECG Accessories) Standards Meet standards of IEC 60601-2-27 and IEC 60601-2-25 Patient connection 3-lead ECG cable, 5-lead ECG cable or 12-lead ECG cable ECG inputs...
  • Page 95 Pace pulse markers Pace pulses meeting the following conditions are labelled with a PACE marker: Amplitude: ±2 to ± 700 mV Width: 0.1 to 2 ms Rise time: 10 to 100 μs (no greater than 10% of pulse width) No overshoot Pace pulse rejection When tested in accordance with the IEC 60601-2-27: 201.12.1.101.13, the heart rate meter rejects all pulses meeting the following conditions.

  • Page 96: Ecg Specifications (From Therapy Accessories)

    ST Segment Analysis Measurement range -2.0 to 2.0 mV RTI Accuracy -0.8 to 0.8 mV: ±0.02 mV or ±10%, whichever is greater. Beyond this range: Not specified. Resolution 0.01 mV QT/QTc Analysis Measurement range QT: 200 to 800 ms QTc: 200 to 800 ms QT-HR: 15 to 150 bpm for adult, 15 to 180 bpm for pediatric and neonate Accuracy QT: ±30 ms...
  • Page 97 Pace pulse markers Pace pulses meeting the following conditions are labelled with a PACE marker: Amplitude: ±2 to ± 700 mV Width: 0.1 to 2 ms Rise time: 10 to 100 μs (no greater than 10% of pulse width) No overshoot Pace pulse rejection When tested in accordance with the IEC 60601-2-27: 201.12.1.101.13, the heart rate meter rejects all pulses meeting the following conditions.

  • Page 98: Resp Specifications

    0 to 120 rpm: ±1 rpm Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s A.8.4 Specifications Mindray SpO Module Standard Meet standards of ISO 80601-2-61 Measurement range 0 to 100% Resolution Response time <...
  • Page 99 Rate Display range 20 to 300 cpm Accuracy range 40 to 160 cpm Accuracy ±3 cpm Resolution 1 cpm Masimo SpO Module Standard Meet standards of ISO 80601-2-61 Measurement range 1% to 100% Resolution Response time ≤20 s (normal perfusion, no disturbance, SpO value sudden changes from 70% to 100%) Accuracy...

  • Page 100: Pr Specifications

    A.8.5 PR Specifications PR from Mindray SpO Module Measurement range 20 to 300 bpm Resolution 1 bpm Response time <30 s (normal perfusion, no disturbance, PR value sudden changes from 25 to 220bpm) Accuracy ±3 bpm Refreshing rate ≤1 s...

  • Page 101: Temp Specifications

    Measurement range Measurement Item Adult Pediatric Neonate Systolic (mmHg) 25 to 290 25 to 240 25 to 140 Diastolic (mmHg) 10 to 250 10 to 200 10 to 115 Mean (mmHg) 15 to 260 15 to 215 15 to 125 Measurement accuracy* Max mean error: ±5 mmHg Max standard deviation: 8 mmHg...

  • Page 102: Co Specifications

    Accuracy ±2% or ±1 mmHg, whichever is greater (excluding sensor error) Refreshing rate ≤1 s Pressure transducer Excitement voltage 5 VDC, ±2% Sensitivity 5 μV/V/mmHg Zero adjustment range ±200 mmHg Impedance range 300 to 3000Ω Volume displacement <0.04 mm /100 mmHg A.8.9 Specifications Measurement mode...
  • Page 103 ≤100% ±1 mmHg ≤60% ≤4% ≤5% ≤5% ≤5% ≤15% ±2 mmHg Inaccuracy specifications are affected by the breath rate and I: E change. The EtCO accuracy is within specification for breath rate ≤ 60rpm and I/E ratio ≤1:1, or breath rate ≤30rpm and I/E ratio ≤ 2:1. means an extra error should be added in case of gas interference when CO measurements are performed between 0- 40mmHg.
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  • Page 105: B Emc And Radio Regulatory Compliance

    EMC and Radio Regulatory Compliance The equipment meets the requirements of IEC 60601-1-2: 2014. WARNING • Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation.
  • Page 106 If the device is operated within the electromagnetic environment listed in Table Guidance and Declaration — Electromagnetic Immunity, the equipment will remain safe and provide the following essential performance: HR accuracy, Resp accuracy, SpO accuracy, PR accuracy, NIBP accuracy, Temp accuracy, IBP accuracy, CO accuracy, Pacing rate accuracy, Pacing output accuracy, energy accuracy, CPR function, alarm, data stored, user’s interface function.
  • Page 107 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. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance...

  • Page 108: Radio Regulatory Compliance

    Recommended Separation Distances between Portable and Mobile RF, Communications Equipment and This Equipment The equipment is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended below, according to the maximum output power of the communication equipment.
  • Page 110 P/N: 046-024585-00(1.0)

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Beneheart d50aBeneheart d50Beneheart d50c

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