Mindray BeneFusion uVP Instructions For Use Manual
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Mindray BeneFusion uVP Instructions For Use Manual

Mindray BeneFusion uVP Instructions For Use Manual

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Instruction for Use

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Summary of Contents for Mindray BeneFusion uVP

  • Page 1 BeneFusion uVP BeneFusion uVP ex Infusion Pump Instruction for Use...
  • Page 3 © Copyright 2021-2022 Shenzhen Mindray Scientific Co., Ltd. All rights reserved. Release date: 2022-11 Revision: 4.0...
  • 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 1.1.1 Warnings ............................1 - 1 1.1.2 Cautions ............................1 - 2 1.1.3 Notes ..............................1 - 2 2 Equipment Introduction ......................2 - 1 2.1 Intended Purpose ............................2 - 1 2.1.1 Indication for Use ..........................2 - 1 2.1.2 Intended Users ..........................2 - 1 2.1.3 Intended Patient Population ....................2 - 1 2.1.4 Intended Medical Conditions ....................2 - 1...
  • Page 8 6 Alarms ............................6 - 1 6.1 Alarm Safety Information ..........................6 - 1 6.2 Understanding the Alarms ........................6 - 1 6.2.1 Alarm Screen ...........................6 - 2 6.3 Pausing Alarm Sound ..........................6 - 2 6.4 Nurse Call .................................6 - 2 6.5 Alarm Solutions .............................6 - 2 6.6 Occlusion Alarm ............................6 - 3 7 Menu Options ..........................7 - 1 8 Infusion Modes ...........................8 - 1...
  • Page 9 A.3.2 Battery ............................. A - 2 A.4 Physical Specifications ..........................A - 2 A.5 Hardware Specifications ........................... A - 3 A.5.1 Displays ............................A - 3 A.5.2 LEDs ..............................A - 3 A.5.3 Audio Indicator ..........................A - 3 A.5.4 Interface Specifications ......................A - 3 A.5.5 Signal Output Specifications ....................
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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: Cautions

    • Do not place the equipment or accessories in any position that might cause it to fall on the patient. • Do not start an infusion unless the setup was verified to be correct. • Clearing the occlusion result from line kinks, filter coagulation, etc. may cause extra bolus to patients.
  • Page 13 The alarm limit settings before power-down are reloaded when the equipment is restarted. • This manual describes all features and options. Your equipment may not have all of them. 1 - 3...
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  • Page 15: Equipment Introduction

    Equipment Introduction Intended Purpose The infusion pump is intended for use for the delivery of medications, solutions, nutrition, lipids, blood and blood components indicated for infusion therapy. WARNING • This pump is intended for use only by clinical professionals or under their guidance.

  • Page 16: Side-Effects

    2.1.6 Side-effects None. Indirect Benefit Through SOTA analysis, since the infusion 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. Applied Part The applied part of the equipment is the infusion set.

  • Page 17: 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 18: Environmental Requirements

    • Save the packing case and packaging material as they can be used if the equipment must be reshipped. • This equipment is in accordance with the EN 1789:2007+A2:2014 standard. Environmental Requirements CAUTION • Make sure that the equipment operating environment meets the specific requirements.

  • Page 19: Setting Up The Equipment

    • The positioning block of the drip chamber must be vertically inserted through the positioning groove of the drop sensor. • Do not excessively tilt the drop sensor, or expose it to direct sunlight during infusion. Otherwise, accuracy of the drop sensor may be influenced. •...
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  • Page 21: Getting Started

    Getting Started Setting Up the Pump WARNING • Check that visual and auditory alarm signals are presented correctly when the equipment is powered on. Do not use the equipment if you suspect it is not working properly, or if it is mechanically damaged. Contact your service personnel or us.

  • Page 22: Starting Infusion

    • We recommend you to use an infusion set stated in this manual. If a non- recommended infusion set must be used, perform the calibration and performance test before use. Otherwise, the accuracy of the infusion and the performance of the pump may be adversely affected. •...

  • Page 23: Purge

    Purge NOTE • If required, set the purge rate after the purge is started. The initial purge rate is 1200 ml/h. • The Air in Line or Accumulated Air alarm will not given during purging. • The volume used for purging is not added to the infused volume. Bolus Infusions NOTE •...

  • Page 24: Unloading The Infusion Set

    Unloading the Infusion Set WARNING • It is recommended to change the infusion set every twenty-four hours (or as per national hygiene regulations or manufacturer’s instructions). If infusion sets not recommended by this manual are used, adjust the fixing site every four hours.

  • Page 25: Using The Dock

    Using the Dock Securing the Pump in the Dock CAUTION • The alarm sound from the pump is disabled when the pump is secured in the BeneFusion nDS Infusion Supervision System (Dock). The alarm sound is given by the Dock. Relay Infusion NOTE •...
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  • Page 27: 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 28: Alarm Screen

    6.2.1 Alarm Screen NOTE • The alarm screen always displays the alarm of the highest priority. Pausing Alarm Sound NOTE • Except for the Battery Depleted alarm, the sounds of all alarms are paused by pressing Nurse Call NOTE • Do not rely exclusively on the nurse call system for alarm notification.

  • Page 29: Occlusion Alarm

    Occlusion Alarm WARNING • If this pump is running at 0.1ml/h, and respectively configure the occlusion pressure alarm limit to the lowest level and highest level, the occlusion alarm delay time may reach up to one hour and 20.5 hours. Adjust the pressure limit to a lower level, or use the syringe pump for a low rate infusion.
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  • Page 31: Menu Options

    Menu Options CAUTION • Verify the volume and brightness settings before entering the night mode. Pay attention to the potential risk if the setting value is low. NOTE • For pumps that are configured with the neonatal settings, you can set some infusion parameters for the neonatal patients in the User Maintenance menu separately.
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  • Page 33: Infusion Modes

    Infusion Modes NOTE • The BeneFusion uVP ex do not provide the Loading Dose Mode. Rate Mode/Time Mode NOTE • When infusing in the rate mode and time mode, you must set rate, but time and VTBI settings are optional.

  • Page 34: Micro-Infusion Mode

    NOTE • If you do not configure the loading dose parameters, the pump infuses at the Primary Rate until the set VTBI is finished. Micro-infusion Mode NOTE • Rate setting is necessary for an infusion, while time and VTBI are optional in the micro-infusion mode.

  • Page 35: Drug Library/Drug Info Library

    Drug Library/Drug Info Library CAUTION • The drug library and the drug info library should be created by professionals. Checked that the drug and parameter settings are suitable for the care area before use. • The facility is responsible for performing initial checks to ensure that the proper drug library is loaded.
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  • Page 37: Managing Patient

    Managing Patient WARNING • Always discharge the previous patient before starting an infusion. Failure to do so can lead to data being attributed to the wrong patient. 10 - 1...
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  • Page 39: Networked Communication

    Networked Communication CAUTION • Wireless network designing, deploying, debugging, and maintenance should be executed by the service personnel or authorized technicians. • Always set the wireless network according to local wireless regulations. • Data communication for all network functions must be performed within a closed network or within a virtually isolated network provided by a hospital.
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  • Page 41: Password Protected Settings

    Password Protected Settings 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. 12 - 1...
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  • Page 43: Maintenance

    Maintenance 13.1 Maintenance Safety Information WARNING • To avoid electric shock, stop using the equipment if you find the housing of the equipment has signs of broken. Contact the service personnel for help in that case. • Failure on the part of the responsible individual hospital or institution using this equipment to implement a recommended maintenance schedule may cause undue equipment failure and possible health hazards.

  • Page 44: Disposing Of The Equipment

    WARNING • Use only specified battery. Use of a different battery may present a risk of fire or explosion. • 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 45: Care And Cleaning

    Care and Cleaning WARNING • Use only the approved cleaners, disinfectants and methods listed in this chapter to clean and disinfect your equipment and accessories. Warranty does not cover damage caused by unapproved substances or methods. • We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection.
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  • Page 47: Accessories

    Accessories WARNING • Use accessories specified in this chapter. Using other accessories may cause damage to the equipment or not meet the claimed specifications. CAUTION • The accessories may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges. If accessory performance is degraded due to aging or environmental conditions, contact your service personnel.
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  • Page 49: A Product Specifications

    Product Specifications Classifications The equipment is classified, according to IEC60601-1: Type of protection against CLASS I EQUIPMENT, equipment energized from an electrical shock internal electrical power source. Degree of protection against Defibrillation-proof type CF applied part (direct cardiac electrical shock application) Mode of operation Continuous...

  • Page 50: Power Supply Specifications

    Power Supply Specifications A.3.1 External Power Supply Specifications Item External AC Power Supply External DC Power Supply 100 VAC to 240 VAC 10 VDC to 16 VDC Voltage 0.5A to 0.21A 3 A to 1.88A Current 50/60 Hz Frequency A.3.2 Battery Battery Type Rechargeable lithium-ion...

  • Page 51: Hardware Specifications

    Hardware Specifications A.5.1 Displays Type Size (diagonal) Resolution ≥ 200x400 pixels Color TFT LCD 3.5 inches A.5.2 LEDs Alarm lamp 1 (two color coded: yellow and red) External power LED 1 (green) Battery LED 1 (green) A.5.3 Audio Indicator Speaker Gives alarm tones (sound pressure 50 to 65 dB).

  • Page 52: Wireless Network

    Action mode Normally open or normally closed (optional) Wireless Network Standards IEEE 802.11a/b/g/n Modulation mode BPSK,QPSK, QAM Operating frequency 2.412GHz to 2.484GHz 5.18GHz to 5.24GHz 5.745GHz to 5.825GHz Data rate IEEE 802.11a: 6 to 54 Mbps IEEE 802.11b: 1 to 11 Mbps IEEE 802.11g: 6 to 54 Mbps IEEE 802.11n: 6.5 to 65 Mbps Transfer power...

  • Page 53: Infusion Specifications

    Infusion Specifications Infusion accuracy: ≤ ±5%(use SHINVA ANDE single use Accuracy infusion set for pump) Infusion accuracy: ≤ ±4.5% (use B. Braun I ntrafix Primeline Bolus accuracy: ≤ ±5% or 0.02ml, whichever is greater Drip accuracy: ≤ ±10% Note:Test in accordance with IEC60601-2-24:2012 Set range of the infusion rate/ Range of rate: 0.10ml/h to 2300ml/h (0.10 ml/h to 2000 purge rage/bolus rate...

  • Page 54: Recommended Infusion Sets

    Conc. unit set range ng/ml, μg/ml, mg/ml, g/ml, mU/ml, U/ml, kU/ml, EU/ml, mmol/ml, mol/ml, mcal/ml, cal/ml, kcal/ml, mEq/ml Dose Rate set range 0.001 to 99999 WARNING • The infusion accuracy and pressure detection is affected by viscosity of liquids and disposables used (for example diameter, material, elasticity and needle).

  • Page 55: Infusion Accuracy Graphs

    Bolus volume after occlusion (ml) Rate High occlusion alarm pressure Low occlusion alarm pressure level level ＜ 0.18 ＜ 0.18 25ml/h Test conditions: ■ Infusion set brand: B.Braun Intrafix Primeline ■ Anti-bolus: On ■ Test temperature: 20 ±2 °C °C ■...
  • Page 56 Trumpet Curve at 1ml/h (last hour) Ep(Max) Ep(Min) Overall percentage error Observation window(min) Start-up graph first 2 hours at 1ml/h Time(min) A - 8...

  • Page 57: A.10.2 Infusion Accuracy At 25Ml/H

    A.10.2 Infusion Accuracy at 25ml/h Trumpet Curve at 25ml/h (2nd hour) Ep(Max) Ep(Min) Overall percentage error Observation window(min) Trumpet Curve at 25ml/h (last hour) Ep(Max) Ep(Min) Overall percentage error Observation window(min) A - 9...

  • Page 58: Operating Environment

    Start-up graph first 2 hours at 25ml/h Time(min) Test conditions: ■ Infusion set brand: B.Braun Intrafix Primeline Test interval: △ t =0.5 minute ■ WARNING • Infusion accuracy may be influenced by the pump's environment (such as pressure, temperature, humidity, brightness, position of drop sensor and any infusion consumables used).

  • Page 59: B Emc And Radio Regulatory Compliance

    EMC and Radio Regulatory Compliance The device 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 60 Guidance and Declaration - Electromagnetic Emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment - guidance Conducted and radiated RF Group 1...
  • Page 61 If the device is operated within the electromagnetic environment listed in Table Guidance and Declaration —Electromagnetic Immunity, the system will remain safe and provide the following essential performance: ■ Operating mode ■ Accuracy ■ Function ■ Protection against UNINTENDED BOLUS volumes ■...
  • Page 62 Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC 60601 test Compliance level Electromagnetic level...
  • Page 63 Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the specified electromagnetic environment. The customer or the user of the device should assure that it is used in such an environment as described below. Immunity IEC 60601 Compliance Electromagnetic environment - test...
  • Page 64 The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.

  • Page 65: Radio Regulatory Compliance

    Radio Regulatory Compliance The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU. CAUTION • Keep a distance of at least 20cm away from the equipment when Wi-Fi function is in use. B - 7...
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  • Page 68 KF-H-046-024481-00(4.0)

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