Mindray BeneHeart D6 Instructions For Use Manual
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Mindray BeneHeart D6 Instructions For Use Manual

Mindray BeneHeart D6 Instructions For Use Manual

Defibrillator/monitor
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BeneHeart D6/BeneHeart D5
Defibrillator/Monitor
Instructions for Use

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  • Page 1 BeneHeart D6/BeneHeart D5 Defibrillator/Monitor Instructions for Use...
  • Page 3 © Copyright 2022 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. ■ Release time: 2022-05 ■ Revision: 1.0...
  • Page 4 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 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 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 The Basics ................................... 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 5.4.1 Changing Arrhythmia Alarm Settings ............................5 - 2 5.4.2 Initiating Arrhythmia Relearning Manually ..........................5 - 3 6 Resting 12-Lead ECG Analysis ............................6 - 1 6.1 Placing 10-leadwire Electrodes ..................................6 - 1 6.2 Entering the 12-lead ECG Screen ................................6 - 1 6.3 Changing 12-Lead ECG Analysis Settings ..............................6 - 1 6.3.1 Enabling Patient Information Input Prompt ...........................6 - 1 6.3.2 Setting the Baseline Drift Removal .............................6 - 1...
  • Page 9 13 Monitoring SpO 2 ........................................13 - 1 13.1 SpO2 Safety Information ..................................13 - 1 13.2 SpO2 Display ....................................... 13 - 2 13.2.1 Setting SpO Sensitivity (for Masimo SpO ) ........................13 - 2 13.3 SpO Desat Alarm ...................................... 13 - 2 14 Monitoring NIBP ................................14 - 1 14.1 NIBP Introduction ......................................
  • Page 10 23 Battery ....................................23 - 1 23.1 Battery Safety Information ..................................23 - 1 23.1.1 Low Battery Alarm ..................................23 - 1 23.2 Conditioning the Battery ..................................23 - 1 23.3 Checking Battery Performance ................................23 - 1 23.4 Storing Batteries ......................................23 - 2 23.5 Recycling the Batteries ....................................
  • Page 11 A.12 Operating Environment ..................................A - 19 B EMC and Radio Regulatory Compliance ..........................B - 1 B.1 EMC ............................................B - 1 B.2 Radio Regulatory Compliance ................................... B - 4...
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  • 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

    • 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.

  • Page 15: Notes

    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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  • Page 17: The Basics

    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.

  • 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: Basic Operations And Settings

    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.

  • Page 20: Basic Operation

    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.

  • Page 21: Alarms

    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.

  • Page 22: Understanding The Alarm Setup Menu

    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.

  • Page 23: Monitoring Ecg

    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. •...

  • Page 24: Checking Paced Status

    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.

  • Page 25: Initiating Arrhythmia Relearning Manually

    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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  • Page 27: Resting 12-Lead Ecg Analysis

    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.
  • Page 28 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.

  • Page 29: Aed

    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.

  • Page 30: Cpr

    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.

  • Page 31: Manual Defibrillation

    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.

  • Page 32: Manual Defibrillation Procedure

    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.

  • Page 33: Synchronized Cardioversion

    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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  • Page 35: Cpr Assistance

    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.

  • Page 36: Reviewing Cpr Events

    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...

  • Page 37: Noninvasive Pacing

    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.

  • Page 38: Pacer Mode

    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. •...

  • Page 39: Monitoring Resp

    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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  • Page 41: Monitoring Pr

    Monitoring PR 12.1 PR Introduction NOTE • A functional tester or SpO simulator can be used to determine the pulse rate accuracy. 12 - 1...
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  • Page 43: Monitoring Spo

    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.

  • Page 44: Spo2 Display

    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.

  • Page 45: Monitoring Nibp

    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.

  • Page 46: Starting Auto Nibp Measurements

    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.

  • Page 47: Monitoring Temp

    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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  • Page 49: Monitoring Ibp

    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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  • Page 51: Monitoring Co 2

    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. •...

  • Page 52: Zeroing The Co Sensor

    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.

  • Page 53: Review

    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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  • Page 55: Data Management

    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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  • Page 57: Recording

    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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  • Page 59: Network Connection

    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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  • Page 61: Battery

    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. •...

  • Page 62: Storing Batteries

    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.

  • Page 63: Care And Cleaning

    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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  • Page 65: Maintenance

    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.
  • Page 66 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. •...

  • Page 67: Accessories

    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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  • Page 69: A Specifications

    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).

  • Page 70: Interface Specifications

    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...
  • Page 71 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...
  • Page 72 Impedance 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 175Ω Accuracy Selected 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 ±15%...

  • Page 73: Cpr Compression Specifications

    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...

  • Page 74: Monitor Specifications

    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...
  • Page 75 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.

  • Page 76: Ecg Specifications (From Defibrillation Electrodes)

    A.5.2 ECG Specifications (from Defibrillation Electrodes) Patient connection paddles or multifunction electrode pads ECG inputs pads/paddles Gain 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV (×1), 20 mm/mV (×2), 40mm/mV (×4), Auto. Error less than ± 5% 6.25mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s. Error no more than ± 5% Sweep speed Bandwidth (-3dB) Therapy mode:...

  • Page 77: Resp Specifications

    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...
  • Page 78 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.

  • Page 79: Pr Specifications

    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...

  • Page 80: Ibp Specifications

    Static pressure measurement accuracy ±3mmHg Maximum measurement time Adult, Pediatric: 180s Neonate: Initial cuff inflation pressure range Adult: 80 to 280 mmHg Pediatric: 80 to 210 mmHg Neonate: 60 to 140 mmHg Default Initial cuff inflation pressure Adult: 160 mmHg Pediatric: 140 mmHg Neonate:...

  • Page 81: Specifications

    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)

  • Page 82: Power Supply Specifications

    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.
  • Page 83 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.

  • Page 84: Recorder Specifications

    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...

  • Page 85: Wi-Fi Specifications

    A.10 Wi-Fi Specifications Protocol IEEE 802.11a/b/g/n Modulation mode DSSS and OFDM Operating frequency IEEE 802.11b/g/n (at 2.4G): 2.4 GHz to 2.495 GHz IEEE 802.11a/n (at 5G): 5.15 GHz to 5.825 GHz Channel spacing IEEE 802.11b/g/n (at 2.4G): 5 MHz IEEE802.11a/n (at 5G): 20 MHz Wireless baud rate IEEE 802.11b: 1 Mbps to 11 Mbps IEEE 802.11g: 6 Mbps to 54 Mbps...

  • Page 86: Environmental Specifications

    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. •...

  • Page 87: Operating Environment

    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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  • Page 89: 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 90 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.
  • Page 91 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 92: 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 94 P/N: KF-H-046-022578-00(1.0)

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