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

Mindray BeneFusion uVP Instructions For Use Manual

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BeneFusion uVP
BeneFusion uVP ex
Infusion Pump
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 2021-2023 Shenzhen Mindray Scientific Co., Ltd. All rights reserved. Release date: 2023-01 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 2 Equipment Introduction ......................2 - 1 2.1 Intended Purpose ............................2 - 1 2.2 Indirect Benefit ..............................2 - 2 2.3 Applied Part ..............................2 - 2 3 Equipment Preparation ......................3 - 1 3.1 Equipment Preparation Safety Information ..................3 - 1 3.2 Installation ..............................3 - 2 3.3 Setting Up the Equipment ........................3 - 2...
  • Page 8 7.7 Rhythm Dose ..............................7 - 2 8 Drug Library/Drug Info Library ....................8 - 1 9 Networked Communication ......................9 - 1 10 Maintenance ...........................10 - 1 10.1 Maintenance Safety Information ....................... 10 - 1 10.2 Maintaining the Battery ........................10 - 1 10.3 Checking the History Record ......................
  • Page 9: 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 10 • 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 11 • Some settings are password protected and can only be changed by authorized personnel. Contact your department manager or biomedical engineering department for the passwords used at your facility. 1.1.3 Notes NOTE • The software was developed in compliance with IEC62304. •...
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  • Page 13: 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 14: Indirect Benefit

    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 15: 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 16: Installation

    NOTE • 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 EN1789:2020 standard, and can be used to transport patient through road ambulance. Installation CAUTION •...
  • Page 17 • Do not touch the power connector with wet hand. Eliminate the liquid or any residue inside of or at the surroundings of the AC power input connector and power cord connectors. • Use the battery if the integrity of the protective earth conductor or the protective earthing system in the installation is in doubt.
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  • Page 19: Getting Started

    Getting Started Turning on the Pump WARNING • Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition. • Check that visual and auditory alarm signals are presented correctly when the equipment is powered on.
  • Page 20: Purge

    Otherwise, the accuracy of the infusion and the performance of the pump may be adversely affected. • To ensure the accuracy of rate and alarm detection, the infusion set should be calibrated in this pump before first use. • When using the pump for blood transfusion, only use disposables dedicated and labelled for transfusion.
  • Page 21: Bolus Infusion

    • If the infusion set type is Nutrition or the selected drug type is Enteral Nutrition, “Air detection will be closed” is always displayed in the system information area, “[Enteral feeding] Air detection will be closed” is displayed before starting the infusion or bolus infusion. •...
  • Page 22: Unloading The Infusion Set

    Unloading the Infusion Set WARNING • To prevent free flow, ensure that the roller clamp or Robert clamp is closed before removing the infusion set from the pump. • It is recommended that the infusion sets be changed every 24 hours (or as per national hygiene regulations or manufacturer’s instructions).
  • Page 23: 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 24: Alarm Solutions

    Alarm Solutions WARNING • When an alarm occurs, check the pump’s status and handle the alarm as soon as possible. If the alarms do not conform with the actual situation, contact your service personnel. NOTE • The pump stops infusion when a high priority alarm is triggered. •...
  • Page 25: Menu Options

    Menu Options 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. 6 - 1...
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  • Page 27: Infusion Modes

    Infusion Modes NOTE • The BeneFusion uVP ex does not provide the Loading Dose Mode. Rate Mode/Time Mode/Drip Mode/Micro-infusion Mode NOTE • When infusing in the rate mode, time mode, drip mode, and micro-infusion mode, you must set rate, but time and VTBI settings are optional.
  • Page 28: Intermittent Mode

    Intermittent Mode NOTE • Total VTBI and Maintain Rate are optional parameters. If the Maintain Rate is not set, infusion stops at the maintenance stage. If the Total VTBI is not set, the infusion stops when the IV container is empty. Ramp Mode NOTE •...
  • Page 29: 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 / drug info library is loaded.
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  • Page 31: 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 33: Maintenance

    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. 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 34 • 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 35: Checking The History Record

    10.3 Checking the History Record NOTE • A total loss of power has no impact on the history records stored. • Alarms are saved as events and will remain if the equipment is powered down. The time of equipment power down is also recorded as an event. •...
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  • Page 37: 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. • Do not mix disinfecting solutions, as hazardous gases may result. •...
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  • Page 39: 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 41: 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 42 AC Power Supply: 100 VAC to 240 VAC, 50/60 Hz, 0.30A to 0.13A Power Supply DC Power Supply: 10 VDC to 16 VDC, 2.0A to 1.3A At least 5.5 hours for normal battery, at least 11 hours for smart battery, and at least 21 hours for dual smart batteries (operating at a rate of 5ml/h or 25ml/h, under standard operating conditions*) At least 1 hour for normal battery, and at least 2.5 hours for...
  • Page 43: Wireless Network

    Wireless Network Standards IEEE 802.11a/b/g/n Modulation mode BPSK, QPSK, 16-QAM, 64-QAM Operating frequency 2412MHz to 2472MHz 5180MHz to 5320MHz 5500MHz to 5700MHz 5745MHz to 5825MHz 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: MCS0 to MCS7 Transfer power <...
  • Page 44 Set range of the infusion rate/ 0.1ml/h to 2000ml/h purge rate/bolus rate Minimum resolution: 0.01ml/h (0.1 to 99.99ml/h) 0.1ml/h (100.0 to 999.9ml/h) 1ml/h (1000 to 2000ml/h) Range of the infusion rate for micro-infusion mode: 0.1ml/h to 100ml/h Set rang of drop rate (1 to 400) d/min Occlusion pressure 50mmHg to 1125mmHg...
  • Page 45: Recommended Infusion Sets

    B. Braun Melsungen AG Primeline 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 - 5...
  • Page 46: 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 < 02:01:00 < 00:04:37 < 00:03:25 < 00:00:30 Bolus volume after occlusion (ml) Rate High occlusion alarm pressure Low occlusion alarm pressure level level...
  • Page 47 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 - 7...
  • Page 48 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 - 8...
  • Page 49 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: B.Braun Intrafix Primelin) 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 50: Operating Environment

    Operating Environment Operating system FreeRTOS Classification OS Core Version Information 9.0.0 A - 10...
  • Page 51: B Emc And Radio Regulatory Compliance

    EMC and Radio Regulatory Compliance The device meets the requirements of IEC 60601-1-2: 2020. 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 52 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 53 NOTE • The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below. • Use of portable or mobile communications devices will degrade the performance of the device. •...
  • Page 54 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 55 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 56 Over the frequency ranges 150 kHz to 80 MHz, field strengths should be less than 3V/m. GUIDANCE AND MINDRAY DECLARATION - ELECTROMAGNETIC IMMUNITY The device 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 57 TABLE EMC-5- Test specifications and minimum distances Recommended separation distances between portable and mobile RF communications equipment and the device The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
  • Page 58 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 59: Radio Regulatory Compliance

    For transmitters at a maximum output power not listed above, the recommended separation distanced in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
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  • Page 62 KF-H-046-024481-00(4.0)

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