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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.
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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.
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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.
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 •...
• Ensure that the equipment is supplied with continuous electric power during work. Sudden power failure leads to the loss of patient data. • Use and store the equipment in specified environmental condition. The equipment and accessories may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range.
devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. • Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or in this manual. •...
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The Basics Intended Use 2.1.1 Intended Purpose Statement The equipment is intended for external defibrillation, internal defibrillation, synchronized cardioversion and semi-automated external defibrillation (AED). It can also be used for non-invasive external pacing as well as ECG, Resp, SpO , PR, NIBP, IBP, Temp and CO monitoring.
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: ◆...
Basic Operations and Settings Equipment 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.
WARNING • Do not use the equipment for any monitoring or therapy procedure on a patient if you suspect it is not working properly, or if it is mechanically damaged. Contact your service personnel or Mindray. NOTE • Check that visual and auditory alarm signals are presented correctly when the equipment is powered on.
Alarms WARNING • A potential hazard exists if different alarm presets are used for the same or similar device in any single area, e.g. an intensive care unit or cardiac operating room. • If the equipment is connected to a CMS, remote suspension, inhibition, silence and reset of monitoring alarms via the CMS may cause a potential hazard.
Understanding the Alarm Setup Menu 4.3.1 Setting Alarm Properties for All Parameters WARNING • Make sure that the alarm limits settings are appropriate for your patient before patient monitoring. • Setting the alarm limit to an extreme value may cause the alarm system to be ineffective. For example, high oxygen levels may predispose a premature infant to retrolental fibroplasia.
Monitoring ECG ECG Safety Information WARNING • ECG monitoring is not suitable for direct cardiac application. • Periodically inspect the electrode application site to ensure skin quality. If the skin quality changes, replace the electrodes or change the application site. •...
5.2.2 Checking Paced Status WARNING • For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the equipment could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak. Do not rely entirely on rate meter alarms when monitoring patients with pacemakers.
5.4.2 Initiating Arrhythmia Relearning Manually NOTE • Arrhythmia relearning in the case of ventricular tachycardia may affect correct arrhythmia alarm. 5 - 3...
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Resting 12-Lead ECG Analysis Placing 10-leadwire Electrodes WARNING WARNING • When using electrosurgical units (ESU), place ECG electrodes between the ESU and its grounding plate to prevent unwanted burns. Never entangle ESU cable and ECG cable together. • When using electrosurgical units (ESU), never place ECG electrodes near to the grounding plate of the ESU, as this can cause a lot of interference on the ECG signal.
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NOTE • Always input the correct patient information before you start 12-Lead ECG analysis because the patient information, especially age, gender, and race, greatly affect the interpretation of the acquired ECG. • If no patient information is inputted, the system will interpret the acquired ECG on the basis of a default of a 50 years old Caucasian male, which may result in misdiagnosis.
AED Safety Information DANGER • Defibrillation current can cause operator or bystander severe injury or even death. Never touch the patient or any metal objects connected to the patient (including the bed or gurney) 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.
to patient and is affected by several factors including the presence of chest hair, moisture, and lotions or powders on the skin. If the “Impedance too high. Shock not delivered” message appears, make sure that the patient’s skin has been dried and that any chest hair has been clipped. If the message persists, change the electrode pads and/or the pads cable.
Manual Defibrillation Manual Defibrillation Safety Information DANGER • Defibrillation current can cause operator or bystander severe injury or even death. Never touch the patient or any metal objects connected to the patient (including the bed or gurney) 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.
NOTE • Impedance is the resistance between the electrode pads/external paddles 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.
Synchronized Cardioversion CAUTION • Using internal paddles for synchronized cardioversion requires that the patient’s ECG be acquired through a standard ECG cable. The patient’s ECG acquired through the internal paddles may be unreliable for synchronized cardioversion due to excessive noise or artifact causing inappropriate R- wave detection.
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CPR Assistance CPR Assistance Introduction 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.
Reviewing CPR Events NOTE • A CPR event is automatically saved in the equipment when the interruption time exceeds five minutes. • You should select [Refresh] to save a CPR event before disconnecting the CPR sensor from the equipment. 9 - 2...
Noninvasive Pacing 10.1 Pacing Introduction NOTE • In the Pacer mode, arrhythmia analysis is supported and available arrhythmia alarms are asystole, ventricular vibrillation and ventricular tachycardia. 10.2 Pacing Safety Information WARNING • Heart rate displays and alarms function during pacing, but they can be unreliable. Observe the patient closely while pacing.
10.3 Pacer Mode CAUTION • Use demand mode pacing whenever possible. Use fixed mode pacing if noise or artifact interferes with proper sensing of R-wave or when monitoring electrodes are not available. • During fixed mode pacing, R-wave markers do not appear on the paced beats. •...
Monitoring Resp 11.1 Resp Safety Information WARNING • When monitoring the patient’s respiration, do not use ESU-proof ECG cables. • The respiration measurement does not recognize obstructive and mixed apneas: it only indicates an alarm when a pre-adjusted time had elapsed since the last detected breath. The safety and effectiveness of the respiration measurement method in the detection of apnea, especially the apnea of prematurity and apnea of infancy, has not been established.
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Monitoring SpO 13.1 Safety Information WARNING • When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. • Do not use SpO sensors during magnetic resonance imaging (MRI). Induced current could potentially cause burns.
The SpO extension cable should be compatible with the SpO connectors. For example, you can only connect the Mindray SpO extension cable to the Mindray SpO connectors. • The SpO simulator can be used to verify the accuracy of the SpO sensor.
Monitoring NIBP 14.1 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.
14.3.2 Starting Auto NIBP Measurements WARNING • Continuous non-invasive blood pressure measurements may cause purpura, ischemia and neuropathy in the limb with the cuff. Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If any abnormity occurs, move the cuff to another site or stop the blood pressure measurements immediately.
Monitoring Temp 15.1 Temp Measurement Procedure NOTE • Verify that the probe detection program works correctly before Temp monitoring. If plug out the probe cable from the T1 or T2 connector, the equipment shall give an alarm and display corresponding message correctly. 15 - 1...
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Monitoring IBP 16.1 IBP Safety Information WARNING • Use only pressure transducers specified in this manual. Never reuse disposable pressure transducers. • Make sure that the applied parts never contact other conductive parts. • To reduce the hazard of burns during high-frequency surgical procedure, ensure that the equipment’s cables and transducers never come into contact with the high-frequency surgical units.
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Monitoring CO 17.1 Safety Information WARNING • Remove the airway sampling line from the patient’s airway while nebulized medications are being delivered. • Leakage in the breathing or sampling system may cause the displayed EtCO values to be significantly low. Always make sure that all components are securely connected. •...
NOTE • Disconnect the sampling line from the module when CO monitoring is not required. • When sample gas of 37 °C, sample flowrate of 50 ml/min, room temperature of 23 °C, 100% RH, the sampling line with a general type should be replaced once at most every 8 hours, and the sampling line with a humidified type should be replaced once at most every 72 hours.
Review 18.1 Reviewing Events NOTE • Pausing or switching off alarms will not be recorded as events. • A total loss of power has no impact on the saved events. • Earlier-recorded events might be overwritten by later ones if it reaches capacity. 18 - 1...
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Data Management 19.1 Generating Patient Data NOTE • A total lost of power has no impact on the saved patient data. 19.2 Exporting Patient Data NOTE • Do not remove the USB flash memory from the equipment before data is completely exported. 19 - 1...
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Recording 20.1 Setting the Recorder NOTE • Switching on or off gridlines is not available for 80 mm recorder paper. 20.2 Loading Paper CAUTION • Use only specified thermal paper. Otherwise, it may cause damage to the recorder’s print head, the recorder may be unable to print, or poor print quality may result.
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Network Connection 21.1 Network 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. • To ensure network security and stability, data communication should be performed within a closed network or within a virtually isolated network provided by a hospital for all network functions.
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Battery 23.1 Battery Safety Information WARNING • The batteries should be charged in this equipment or in a device approved by the equipment manufacturer. • Keep the batteries out of children’s reach. • Use only specified batteries. NOTE • Always connect the equipment to AC mains whenever it is possible. •...
23.4 Storing Batteries NOTE • Remove the battery from the equipment if the equipment is not used for a prolonged time (for example, several weeks). Otherwise the battery may overdischarge. • Storing batteries at high temperature for an extended period of time will significantly shorten their life expectancy.
Care and Cleaning WARNING • The responsible hospital or institution shall carry out all cleaning and disinfection procedure specified in this chapter. 24.1 General Points WARNING • Be sure to shut down the system, disconnect the power cord and other cables, and remove the batteries before cleaning the equipment.
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Maintenance 25.1 Maintenance Safety Information 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.
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NOTE • Before the user test or after each use, thoroughly clean the external paddles and properly place them in the paddle tray. The user test passes only when external paddles properly contact the metal parts of the paddle tray. •...
Accessories WARNING 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.
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Specifications General Specifications A.1.1 Safety Specifications The equipment is classified, according to IEC 60601-1: Type of protection against electrical shock Class I, equipment energized from an external and internal electrical power source. If you suspect the integrity of the external protective earthing or the protective earthing wire, you should run the equipment on internal electrical power supply (battery).
A.1.5 Interface Specifications USB connector Connects USB flash memory VGA connector Connects TFT display of medical grade. RJ45 connector Connects standard network cable. Multifunctional connector Connects a cable for analog output or a cable for synchronized cardioversion. A.1.6 Signal Outputs Specifications Multifunctional connector Standard Meets the requirements of EN60601-1 for short-circuit protection and...
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Shocks: 1, 2, 3, configurable; Meeting AHA/ERC guidelines 2015 by default AED ECG analysis performance Refer to B Mindray Shockable Rhythm Analysis Algorithm. 360 J defibrillation waveform into impedance of 25Ω, 50Ω, 75Ω, 100Ω, 125Ω, 150Ω, 175Ω Time (ms) A - 3...
CPR Compression Specifications CPR Compressions from Defibrillation Electrodes Compression rate Measurement range: 60 to 200 cpm (compressions per minute) Accuracy: ±3 cpm (compression per minute) CPR Compressions from CPR Sensor Compression depth Measurement range: 0.0 to 8.0 cm Effective range: 1.5 to 8.0 cm Accuracy (for effective range): ±0.5 cm or ±10%, whichever is greater Resolution: 0.1 cm Refreshing rate: ≥0.5Hz...
Monitor Specifications A.5.1 ECG Specifications (from ECG Lead Set) 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 3-lead ECG set: I, II, III 5-lead ECG set: I, II, III, aVR, aVL, aVF, V 12-lead ECG set: I, II, III, aVR, aVL, aVF, V1 to V6...
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Measurement range Neonate: 15 to 350 bpm Pediatric: 15 to 350 bpm Adult: 15 to 300 bpm Accuracy ±1% or ±1bpm, which ever is greater Resolution 1 bpm Sensitivity 200 μV (lead II) Heart rate averaging In compliance with the requirements in Clause 201.7.9.2.9.101 b) 3) of IEC 60601-2-27, the following method is used: If the last 3 consecutive RR intervals are greater than 1200 ms, the 4 most recent RR intervals are averaged to compute the HR.
2200 to 4500Ω, using an ECG cable with 1 kΩ resistor Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s A.5.4 Specifications Mindray SpO Module Standard Meet standards of ISO 80601-2-61 Measurement range...
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Accuracy* 70 to 100%: ±2% (in adult/pediatric mode) 70 to 100%: ±3% (in neonate mode) 0% to 69%: Not specified Refreshing rate ≤2 s *Measurement accuracy verification: The SpO accuracy has been verified in human experiments by comparing with arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO- oximeter measurements.
A.5.5 PR Specifications PR from Mindray SpO Module Measurement range 20 to 300 bpm Resolution 1 bpm Accuracy ±3 bpm Response time <20 s (PR value sudden changes from 25 to 240 bpm) PR from Masimo SpO Module Measurement range...
A.5.9 Specifications Sidestream CO Module Measurement range 0 to 150 mmHg Accuracy* Full accuracy mode: 0 to 40 mmHg: ±2 mmHg 41 to 76 mmHg: ±5% of reading 77 to 99 mmHg: ±10% of reading 100 to 150 mmHg: ±(3 mmHg+8% of reading) ISO accuracy mode: Add ±2mmHg to the full accuracy mode Sart-up time 20 s (typical), 90 s (maximum)
Microstream CO Module Measurement range 0 to 99 mmHg Accuracy* 0 to 38 mmHg: ±2 mmHg 39 to 99 mmHg: ±5% of reading (0.08% increased in error for every 1 mmHg if the reading is more than 38) * Accuracy applies for respiration rate up to 80 rpm. For respiration rate above 80 rpm, the accuracy is 4 mmHg or ±12% of the reading, whichever is greater, for EtCO2 exceeding 18 mmHg.
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Battery LI34I001A charge Charged by the equipment Less than 2 hours to 90% and less than 3 hours to 100% time connected to the AC power with equipment power off; Less than 6 hours to 90% and less than 9 hours to 100% with equipment power on.
Recorder Specifications Method High-resolution thermal dot array Number of waveforms • 50 mm recorder paper: 3 at maximum. • 80 mm recorder paper: 4 at maximum. 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s. Error no more than ± 5% Paper speed Paper width 50 mm, 80 mm...
A.11 Environmental Specifications WARNING • The equipment may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges. If the performance of the equipment is degraded due to aging or environmental conditions, contact your service personnel. •...
Shock Complies with the requirements of 6.3.4.3, EN1789. Drop height: 0.75 m Number of drops: once for each of the six surfaces A.12 Operating Environment Host CPU Intel Atom Primary programming language Operating system Linux 3.2.0 A - 19...
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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.
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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, Temp accuracy, NIBP accuracy, IBP accuracy, CO accuracy, Pacing rate accuracy, Pacing output accuracy, energy accuracy, CPR function, alarm, data stored, user’s interface function.
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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...
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.
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