Mindray BeneFusion mNP Operator's Manual
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Mindray BeneFusion mNP Operator's Manual

Mindray BeneFusion mNP Operator's Manual

Enteral feeding pump
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BeneFusion mNP
Enteral Feeding Pump
Operator's Manual

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Summary of Contents for Mindray BeneFusion mNP

  • Page 1 BeneFusion mNP Enteral Feeding Pump Operator’s Manual...
  • Page 3 © Copyright 2023 Shenzhen Mindray Scientific Co., Ltd. All rights reserved. Release date: December 2023 Revision: 1.0...
  • Page 4 Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray Scientific shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
  • Page 5 Mindray Scientific or repairs by people other than Mindray Scientific authorized personnel.
  • Page 6 Notification of Adverse Events As a health care provider, you may report the occurrence of certain events to SHENZHEN MINDRAY SCIENTIFIC 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 1.2 Equipment Symbols ............................1 - 3 2 Equipment Introduction ......................2 - 1 2.1 Intended Purpose ............................2 - 1 2.2 Indirect Benefit ..............................2 - 2 2.3 Applied Part ..............................2 - 2 2.4 Main Unit .................................2 - 2 2.5 Screen Display ...............................2 - 4 3 Equipment Preparation ......................3 - 1...
  • Page 8 5.7 Occlusion Alarm ............................5 - 6 6 Menu Options ..........................6 - 1 6.1 General Option ..............................6 - 1 6.2 Department Management ........................6 - 2 6.3 System Options .............................6 - 2 6.4 User Maintenance ............................6 - 2 7 Infusion Modes ...........................7 - 1 7.1 Continuous Feeding/Time Feeding/Nourishing Feeding .............7 - 1 7.2 Intermittent Feeding ...........................7 - 1 8 Feeding Library ..........................8 - 1...
  • Page 9 A.7 Operating Environment ..........................A - 9 B EMC and Radio Regulatory Compliance ...................B - 1 B.1 EMC ..................................B - 1 B.2 Radio Regulatory Compliance .........................B - 9 C Abbreviations ..........................C - 1...
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  • Page 11: Safety

    Safety Safety Information WARNING • Indicates a potential hazard or unsafe practice that, if not avoided, could result in death, serious injury or damage to product/property. CAUTION • Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury, product malfunction or damage to product/ property.
  • Page 12 • Do not open the equipment housings. All servicing and future upgrades must be carried out by trained and authorized personnel. Moreover, the servicing must be done only after the AC power supply is disconnected. • Do not place the equipment or accessories in any position that might cause it to fall on the patient.

  • Page 13: Equipment Symbols

    • Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force. The equipment should be observed to verify normal operation after fall, otherwise it cannot be used. • Dry the equipment immediately in case of rain or water spray. •...
  • Page 14 Non-ionizing electromagnetic General warning sign radiation Unique device identification Medical Device Date of manufacture Manufacturer Serial number Authorized representative in the European Community Protected against solid DEFIBRILLATION-PROOF foreign objects with a TYPE CF APPLIED PART diameter no less than 1.0 mm in diameter.
  • Page 15 The general meaning assigned to geometric shapes, safety colors and contrast colors for safety signs are as follows: Geometric Meaning Safety color Contrast Graphical shape color symbol color Mandatory Blue White White action Warning Yellow Black Black 1 - 5...
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  • Page 17: Equipment Introduction

    Equipment Introduction Intended Purpose The enteral feeding pump is intended for use for the delivery of enteral nutrition for enteral therapy with feeding set. WARNING • This pump is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use.

  • Page 18: Indirect Benefit

    2.1.5 Contra-indications The enteral feeding pump can not be used for arterial or intravenous route. 2.1.6 Side-effects None. Indirect Benefit Through SOTA analysis, since the enteral feeding pump is not directly used to treat diseases, it will not produce the direct clinical benefits, and its clinical benefits are mainly indirect clinical benefits (a positive impact on patient management): precise infusion.
  • Page 19 Tubing channel notches Air in line sensor Pumping mechanism (with Pressure sensor waterproof membrane) Anti free-flow clamp 2.4.2 Rear View Pole clamp Pole clamp handle Product label 2 - 3...

  • Page 20: Screen Display

    Multifunctional connector (optional) • Uses as a DC power input connector. • Uses as a RS232 connector. • Connects to the hospital’s nurse call system. USB connector Connects USB devices, for example the USB drive. AC power input connector Screen Display The screen may look slightly different in different infusion modes.
  • Page 21 Symbol Description Symbol Description The battery has critically No battery is installed, low charge and needs to be battery fault, battery charged immediately. communication fault, or Otherwise, the equipment battery charging fault. will automatically shut Contact service personnel down. for help. The battery has low power and needs to be charged.
  • Page 22 Symbol Label Function Symbol Label Function Setup Enters the Cancel Cancels the Standby shutdown Time setup and returns to menu or the the main parameter screen. setup screen. Turn Off Turn off the Standby Enters pump. Standby. 2.5.3 Using the Touchscreen You can use the touchscreen to select a screen element by pressing directly on the pump’s screen.

  • Page 23: 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 Scientific. •...

  • Page 24: Installation

    NOTE • Save the packing case and packaging material as they can be used if the equipment must be reshipped. Installation 3.2.1 Pole Clamp Installation By turning the pole clamp handle, the pole clamp secures the pump to either a horizontal or vertical bar of the medical supply unit or IV pole.
  • Page 25 WARNING • Always use the accompanying power cord delivered with the pump. • Before connecting the equipment to the AC mains, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment. •...
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  • Page 27: Getting Started

    Getting Started Turning on the Pump Press the power switch to turn on the pump. The pump automatically performs a self test at startup. Check that the alarm tone is heard and the alarm lamp illuminates, one after the other, in red and yellow. This indicates that the visible and audible alarm indicators function correctly.
  • Page 28 Avoiding any slack, insert the infusion line into the slot, following the flow direc- tion indicator (1). Ensure that the infusion set is straightly and firmly clipped into the tubing channel notches (2) on both sides of the casing. Close the pump door. WARNING •...

  • Page 29: Purge

    NOTE • Take care that your hands are not squeezed when you close the pump door. • Make sure that the infusion set is located in both sides of the tubing channel notches after loading the infusion set. Purge The infusion set should be purged prior to being connected to a patient. If the infusion set is not purged before being loaded into the pump, proceed as follows to purge the line: Ensure that the pump is disconnected from the patient.

  • Page 30: Bolus Infusion

    • Check that no drops are falling in the drip chamber before infusion starts or stops. If drips are falling, close the roller clamp or the Robert clamp, do not use the equipment, and contact your service personnel. NOTE • Always discharge the previous patient before starting a new infusion for new patient.

  • Page 31: Pausing The Infusion

    To change other infusion parameters, follow this procedure: Press pause the infusion. Select the desired parameter area, and reconfigure parameters as per the prescriber’s order. Pausing the Infusion Press temporarily stop a running infusion. Press again to restart the infusion after the infusion solution change. Setting Keep Tube Open (KTO) Rate At the end of infusion, the pump continues to infuse at a very low rate.

  • Page 32: Unloading The Infusion Set

    4.11 Unloading the Infusion Set To unload the infusion set, follow this procedure: In the main screen, select stop the infusion. Close the roller clamp or Robert clamp. Disconnect the patient from the infusion set. Press the door opening key to open the pump door. On the outside of the pump, grasp the tubing on both sides of the pump and pull the tubing straight out of the pumping channel.

  • Page 33: Entering The Standby Mode

    Past 24h Total: view the total infused volume in the past 24 hours. The display range is 0 ml to 99999.99 ml. Select Clear to clear the infused volume. View the recent total infused volume. Configure the time before viewing the total infused volume within the configured time.
  • Page 34 CAUTION • Press and hold the power switch for no less than 10 seconds to forcibly shut down the pump if it could not be shut down normally. This may cause loss of patient data. NOTE • Turning off the pump does not disconnect the pump from the AC mains. To completely disconnect the power supply, unplug the power cord.

  • Page 35: Alarms

    Alarms Alarm Safety Information WARNING • A potential hazard can exist if different alarm presets and default settings are used for the same or similar equipment in the same care area, for example an intensive care unit or cardiac operating room. •...

  • Page 36: Alarm Screen

    Alarm Alarm Alarm Alarm Alarm Alarm Duty priority lamp lamp sound message priority Cycle color flashing interval indicator frequency Yellow 20s (±2s) Black text 100% priority flashing or symbol alarm inside a yellow NOTE • The tones of the alarm sound and the reminder sound are different. •...

  • Page 37: Pausing Alarm Sound

    ■ appears before the alarm message, indicating that the alarm is acknowledged. ■ The alarm reset symbol is displayed after the alarm message. For the VTBI Complete, KTO Finish, Standby Time Expired and Empty alarms, when they are reset, all the alarm indications (alarm sound, alarm message, and alarm light) disappear.
  • Page 38 Alarm Priority Causes Solutions Upstream High An occlusion occurred at • Check if kinks are in tubing Occlusion the supply end (the and tubing isn't damaged. tubing between the • Check the infusion set container and the patency. pump). Downstream High An occlusion occurred at •...
  • Page 39 Alarm Priority Causes Solutions Press KTO Finish High The KTO infusion is • to reset the alarm. running for thirty • Continue therapy or select minutes. new therapy. System Error High The pump system faults, Stop using the pump, and such as battery error, etc.

  • Page 40: Occlusion Alarm

    Alarm Priority Causes Solutions Reminder No operation is detected Turn off the pump or enter the after the preset standby. Reminder Time is reached. Low Battery Low battery. Connect the pump to the external power source. Press acknowledge Para. No operation is detected •...

  • Page 41: Menu Options

    Menu Options General Option Swipe the touchscreen from top down → select Menu → select General Option. Menu Item Range Function Bubble Size 50, 500, 1000, 1500, 2000, 4000 Set the alarm limit for the size of μl single air bubble. Time Near End Off, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, Set for how long the Time Near...

  • Page 42: Department Management

    Department Management Menu Item Function Applied Department The checked department can be displayed in the title area of the drug selection screen. The drug in the drug selection screen switches to the drug of corresponding department. Drug Management Add drug, modify drug, and delete drug. Note:The build-in drug is not allowed to be deleted.
  • Page 43 CAUTION • The maintenance settings can only be changed by authorized personnel. Contact your department manager or biomedical engineering department for the passwords used at your facility. Menu Item Function Device Management Set the facility, department, device name, QR code type, QR code prefix, and asset number.
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  • Page 45: Infusion Modes

    Infusion Modes The pump supports continuous feeding, time feeding, nourishing feeding, and intermit- tent feeding. Continuous Feeding/Time Feeding/Nourishing Feeding In continuous feeding, time feeding, and nourishing feeding, the IV drug therapy continues to infuse at a set rate. Nourishing feeding is typically use for low rate infusions for pediatric patients.
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  • Page 47: Feeding Library

    Feeding Library The pump can be configured with a feeding library, which predefines drugs, concentrations, occlusion pressure levels and other infusion parameters. Using a feeding library simplifies the infusion operation, and reduces the risk of operation fault. The feeding library is created, edited, and imported via the PC program.It has the following features: ■...
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  • Page 49: Networked Communication

    Networked Communication The equipment can be connected to the BeneFusion nCS Infusion Supervision System and BeneVision Central Monitoring System (hereafter both referred to as “CMS”), and the eGateway. Network Safety Information CAUTION • Wireless network designing, deploying, debugging, and maintenance should be executed by the service personnel or authorized technicians.

  • Page 50: Connecting The Equipment To The Egateway

    ■ Patient can be admitted or discharged by the CMS, and patient information can be transmitted to this equipment. Connecting the Equipment to the eGateway You can connect the equipment to the eGateway to implement interaction between the equipment and the Hospital Information System (HIS) via the HL7 protocol. When connected to the eGateway, the system provides the following functions: ■...

  • Page 51: Maintenance

    Maintenance Regular maintenance is essential to ensure that the equipment functions properly. This chapter contains information on periodic testing and maintenance. 10.1 Maintenance Safety Information WARNING • To avoid electric shock, stop using the equipment if you find the housing of the equipment has signs of broken.

  • Page 52: Maintenance And Testing Schedule

    • The maintenance personnel should confirm the accuracy of the pump every three years. If the accuracy not meet the claimed accuracy, perform the accuracy calibration and verity whether the accuracy meets the claimed specification. • After the maintenance personnel complete the pressure calibration, the pressure accuracy must be tested to confirm whether the calibration is valid.

  • Page 53: Maintaining The Battery

    • The battery must only be installed and replaced by service personnel trained and authorized by Mindray Scientific. • Do not crush, drop or puncture the battery. Mechanical abuse can lead to internal damage and internal short circuits. If a battery has been dropped or banged against a hard surface, whether damage is externally visible or not, remove the battery from use and dispose of it properly.

  • Page 54: Checking The History Record

    • If the battery is not conditioned for a prolonged time, its charge indication may not be accurate and you may wrongly evaluate the remaining battery runtime. • Do not use the pump for infusion during battery conditioning. • Do not interrupt battery conditioning. 10.4 Checking the History Record The History Record menu shows the history of pump activities, including the infusions,...

  • Page 55: Care And Cleaning

    Care and Cleaning In this chapter we only describe cleaning and disinfection of the pump, pole clamp and DC adapter. For the cleaning and disinfection of other reusable accessories, refer to their instructions for use. 11.1 Care and Cleaning Safety Information WARNING •...

  • Page 56: Cleaning The Equipment

    • Check the equipment after cleaning and disinfecting. If there is any sign of damage, remove it from use. 11.2 Cleaning the Equipment Clean the equipment on a regular basis. Before cleaning, consult your hospital’s regulations. To clean the equipment, follow this procedure: Dampen a soft lint-free cloth with water or ethanol (70%).
  • Page 57 Product Name Product Type Manufacturer Metrex CaviWipes™ Wipes METERX® RESEARCH PDI Sani-Cloth® AF3 Wipes PDI Inc. Germicidal Disposable Wipe PDI Sani-Cloth® Bleach Wipes PDI Inc. Germicidal Disposable Wipe PDI Sani-Cloth® HB Wipes PDI Inc. Germicidal Disposable Wipe PDI Sani-Cloth® Plus Wipes PDI Inc.
  • Page 58 Product Name Product Type Manufacturer Tristel Duo™ Liquid, foam Tristel solutions Limited Tristel Jet Liquid, spray Tristel solutions Limited Tristel Fuse Liquid Tristel solutions Limited For Surfaces, 196ppm Surfanios Premium, 0.25% Liquid ANIOS LABORATORIES Surfa 'safe Liquid, spray ANIOS LABORATORIES Wip' Anios premium Wipes ANIOS LABORATORIES...

  • Page 59: Cleaning The Pole Clamp And Dc Adapter

    Product Name Product Type Manufacturer mikrozid® AF Wipes Schülke & Mayr GmbH Wipes Terralin® Liquid Schülke & Mayr GmbH Liquid Perform® Classic Powder Schülke & Mayr GmbH Concentrate OXY, 0.5% 11.4 Cleaning the Pole Clamp and DC Adapter Clean the pole clamp and DC adapter on a regular basis. To clean the pole clamp and DC adapter, follow this procedure: Clean the pole clamp and DC adapter with a soft cloth moistened with water or ethanol (70%).

  • Page 60: Sterilization

    Product Name Product Type Manufacturer Terralin® Liquid Schülke & Mayr GmbH Liquid CAUTION • To avoid long term damage, the accessories should be disinfected only when necessary as determined by your hospital’s policy. 11.6 Sterilization Sterilization is not recommended for this equipment, related products, accessories, or supplies unless otherwise indicated in the Instructions for Use that accompany the products, accessories or supplies.

  • Page 61: Accessories

    Accessories The accessories listed in this chapter comply with the requirements of IEC 60601-1-2 when in use with the equipment. For details about the accessories, refer to the instructions for use provided with the accessory. WARNING • Use accessories specified in this chapter. Using other accessories may cause damage to the equipment or not meet the claimed specifications.
  • Page 62 Description 034-000998-00 MIP-300 IV Pole (Basic) 034-000999-00 MIP-600 IV Pole (Luxury) 034-001011-00 MIP-500 IV Pole (Syringe Pump Luxury) 12 - 2...

  • Page 63: A Product Specifications

    Product Specifications Specifications Connect to AC power source, type of protection against electrical shock: CLASS I EQUIPMENT, equipment energized from an internal electrical power source Connect to DC power source, type of protection against electrical shock: CLASS II EQUIPMENT, equipment energized Classifications from an internal electrical power source Degree of protection against electrical shock: Defibrillation-...

  • Page 64: Wireless Network

    100mm x 95mm x 200mm (without pole clamp, the error is Main unit (W × D × H) ±3mm) 4.3 inches Color TFT LCD, resolution ≥ 272x480 pixels Display Gives alarm tones (sound pressure 50 to 75 dB). Speaker Supports multi-level tone modulation. Alarm tones comply with IEC 60601-1-8.

  • Page 65: Infusion Specifications

    Operating mode Transmitting data through the wireless access point (AP) Data security Standard: OPEN and WPA/WPA2-PSK Encryption: TKIP and AES Number of the pumps supported by a single AP: ≤ 16 System capacity Data transmission delay Total data transmission delay time between the pump and the CMS is ≤...

  • Page 66: Recommended Infusion Sets

    Feeding Set CO., LTD NOTE • The pump will not affect the quality of disposables from other suppliers. Changes in quality may affect the technical data of the pump. Mindray Scientific is not responsible for such changes. A - 4...

  • Page 67: Occlusion Alarm Delay And Bolus Volume

    Occlusion Alarm Delay and Bolus Volume Occlusion alarm delay time (hh: mm: ss) Rate (ml/h) High occlusion alarm pressure Low occlusion alarm pressure level level ＜ 01:50:00 ＜ 00:04:00 ＜ 00:03:00 ＜ 00:00:30 Bolus volume after occlusion (ml) Rate High occlusion alarm pressure Low occlusion alarm pressure level level...

  • Page 68: Infusion Accuracy Graphs

    Infusion Accuracy Graphs A.6.1 Infusion Accuracy at 1 ml/h Trumpet Curve at 1ml/h (2nd hour) Ep(Max) Ep(Min) Overall percentage error(A) Observation window(min) Trumpet Curve at 1ml/h (last hour) Ep(Max) Ep(Min) Overall percentage error(B) Observation window(min) A - 6...
  • Page 69 Start-up graph first 2 hours at 1ml/h Time(min) A.6.2 Infusion Accuracy at 25ml/h Trumpet Curve at 25ml/h (2nd hour) Ep(Max) Ep(Min) Overall percentage error(A) Observation window(min) A - 7...
  • Page 70 Trumpet Curve at 25ml/h (last hour) Ep(Max) Ep(Min) Overall percentage error(B) Observation window(min) Start-up graph first 2 hours at 25ml/h Time(min) Test conditions: ■ Infusion set brand: SHINVA ANDE EIS-22-A Test interval: △ t =0.5 minute ■ WARNING • Infusion accuracy may be influenced by the pump's environment (such as pressure, temperature, humidity, and any infusion consumables used).

  • Page 71: Operating Environment

    Operating Environment Operating system FreeRTOS Classification OS Core Version Information 9.0.0 A - 9...
  • Page 72 This page intentionally left blank. A - 10...

  • Page 73: B Emc And Radio Regulatory Compliance

    EMC and Radio Regulatory Compliance The system complies with the EMC standard IEC60601-1-2:2020. WARNING • The use of unapproved accessories may diminish system performance. • Use of components, accessories, probes, and cables other than those specified may result in increased emission or decreased immunity of system. •...
  • Page 74 Data stored Table EMC-1 Guidance and Mindray Declaration - Electromagnetic Emissions The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment.
  • Page 75 Table EMC-2 Guidance and Mindray Declaration - Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment. Immunity test...
  • Page 76 Table EMC-3 Guidance and Mindray Declaration - Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment. Immunity IEC 60601...
  • Page 77 Over the frequency ranges 150 kHz to 80 MHz, field strengths should be less than 3V/m. Table EMC-4 Guidance and Mindray Declaration - Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment.
  • Page 78 Table EMC-5 Test specifications and minimum distances Recommended Separation Distances between Portable and Mobile RF Equipment and the System The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment.
  • Page 79 1720 1700 - Pulse 1990 1800, modulati 1845 CDMA 1900, 217 Hz 1970 1900, DECT, LTE Band 1, 3, 4, 25, UMTS 2450 2400 - Bluetooth Pulse 2570 , WLAN, modulati 802.11 b/ g/n, RFID 217 Hz 2450, LTE Band 7 5240 5100 - WLAN,...
  • Page 80 Table EMC-6 Recommended Separation Distances between Portable and Mobile RF Communications Device and the System The system is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and system as recommended below, according to the maximum output power of the communication equipment.

  • Page 81: Radio Regulatory Compliance

    Radio Regulatory Compliance Refer to A.2 Wireless Network for the details of RF parameters. WARNING • Keep a distance of at least 20cm away from the equipment when Wi-Fi function is in use. B - 9...
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  • Page 83: C Abbreviations

    Abbreviations Abbreviation In Full Alternating Current Anti-Bolus Anti-Bolus BOLUS Bolus CCU(CICU) Cardiac Intensive Care Unit Conformité Européenne CISPR International Special Committee on Radio Interference Central Processing Unit Direct Current DERS Dose Error Reduction Systems Dynamic Pressure System European Economic Community Electromagnetic Compatibility Electromagnetic Interference Ethylene oxide...
  • Page 84 Abbreviation In Full IEEE Institute of Electrical and Electronic Engineers International Organization for Standardization Intravenous Keep Tube Open Light Emitting Diode Maximum Medical Device Directive Minimum Magnetic Resonance Imaging Not Applied Operating Room Series Number Universal Serial Bus VTBI Volume To Be Infused C - 2...
  • Page 86 KF-H-046-028420-00(1.0)

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