Mindray BeneFusion VP5 Operator's Manual
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Mindray BeneFusion VP5 Operator's Manual

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Operator's Manual

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  • Page 1 BeneFusion VP5/ BeneFusion VP5 Ex/ BeneFusion VP5 Neo Infusion Pump Operator’s Manual...
  • Page 3 © Copyright 2018 Shenzhen Mindray Scientific Co., Ltd. All rights reserved. Release date: December 2018 Revision: 1.0...
  • Page 4 This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray Scientific, nor the rights of others. Mindray Scientific intends to maintain the contents of this manual as confidential information.
  • Page 5 Mindray Scientific or repairs by people other than Mindray Scientific authorized personnel.
  • Page 6 Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product.

  • 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 ....................1-3 1.1.3 Notes ....................... 1-4 1.2 Equipment Symbols .................... 1-5 2 Overview ....................... 2-1 2.1 Description ......................2-1 2.1.1 Intended Use ................... 2-1 2.1.2 Contraindications ..................
  • Page 8 4.2 Operational Procedures ..................4-2 4.2.1 Turn on the Pump ................... 4-2 4.2.2 Load the Infusion Set ................4-2 4.2.2.1 Infusion Pump with Conventional Infusion Sets ......4-2 4.2.2.2 Infusion Pump with Silicone Specified Infusion Sets ...... 4-4 4.2.2.3 Infusion Pump with PVC Specified Infusion Sets......4-5 4.2.3 Change the Infusion Set .................
  • Page 9 6.9 Time Near End ....................6-5 6.10 Commonly Used Infusion Sets................6-5 6.10.1 Infusion Pump with Conventional Infusion Sets ........6-5 6.10.2 Infusion Pump with Silicone Specified Infusion Sets ......6-5 6.10.3 Infusion Pump with PVC Specified Infusion Sets ......... 6-6 6.11 Set the Sensitivity of Empty Bottle Alarm ............
  • Page 10 A.1.2 Operating Environment................A-2 A.2 Physical Specifications ..................A-2 A.3 Hardware Specifications ..................A-3 A.3.1 Display ....................A-3 A.3.2 Battery ....................A-3 A.3.3 Host LED ....................A-3 A.3.4 Auditory Indicator ................... A-3 A.3.5 External Ports ..................A-4 A.3.6 Signal Output Interface ................A-4 A.4 Specifications .....................

  • Page 11: Safety

    Safety 1.1 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 Accuracy Calibration and Pressure Calibration shall be performed sequentially, the infusion sets can only be used after confirmation, otherwise Mindray Scientific is not responsible for infusion performance (such as accuracy, air bubble and pressure) and relevant alarm function of the infusion pump. Its accuracy cannot be guaranteed...

  • Page 13: Cautions

     Infusion pump with specified infusion sets has to be used with specified infusion sets.  When operating the pump and under non-running status, please carefully check whether there is leakage from the tube export of the infusion set, and drop needle of the drip chamber. If any leakage is found, please contact the manufacturer for maintenance and confirmation.

  • Page 14: Notes

    necessary for other equipment used in the vicinity of the pump to meet EMC standards. Mobile phones, X ray and MRI equipment are all potential interference sources because of their high-intensity electromagnetic radiation.  Before the equipment is connected to the power supply, check that the voltage and frequency of the power supply match the specifications on the label or in this Operator’s Manual.

  • Page 15: Equipment Symbols

    1.2 Equipment Symbols Some symbols may not appear on your equipment. Refer to instruction ON/OFF manual/booklet Alternating current Battery Direct current Caution Alarms AUDIO PAUSED Clear/Back Start; start of action Bolus Confirm Stop Menu Move up/Increase Move down/Decrease Move left Move right Night mode Equipotentiality...
  • Page 16 Executing prescription Non-executed prescription Date of manufacture Manufacturer Authorized representative in the Serial number European Community DEFIBRILLATION-PROOF Recovery/recyclable TYPE CF APPLIED PART THIS WAY UP Keep dry Fragile, handle with STACKING LIMIT BY care NUMBER CE mark, comply with the Environmentally-friendly requirements of the use periods of...

  • Page 17: Overview

    Overview 2.1 Description 2.1.1 Intended Use The infusion pump is used in conjunction with the infusion set to control the dose of liquid infused into the patient’s body. The pump may also be used for blood transfusion. For this therapy only use disposables dedicated and labelled for transfusion.

  • Page 18: Host

    of the software comprise Rate Mode, Time Mode, Body Weight Mode, Ramp Up/Down Mode, Sequential Mode, Loading Dose Mode, Micro-infusion Mode, Drug Library, History Record and Anti-bolus Function. The infusion pump also includes IV sets as applied parts. Since some parts and functions are optional, the infusion pump you purchased may not contain these additional parts and their relevant functions.
  • Page 19 6. <DIRECTION> Used for adjusting value, changing lines and pages. 7. <CLEAR/BACK>  Under the setting status, press this key to set the value to "0".  Edited value is "0", press this key to return the value to the previous value. ...

  • Page 20: Rear View

    2.2.2 Rear View 1. Battery compartment 2. Connection rail Track for stacking pumps. 3. Equipotentiality terminal When other device and infusion pump are used together, please adopt wires to connect other devices and equipotential port of the pump, to eliminate ground potential difference between different devices and ensure safety.

  • Page 21: Side View With The Door Opened

    2.2.4 Side View with the Door Opened 2.2.4.1 Infusion Pump with Conventional Infusion Sets 1. Connection rail 2. Liquid check clip button 3. Ultrasonic sensor 4. Downstream pressure checkout slot 5. Infusion set slot 6. Waterproof membrane 7. Upstream pressure checkout slot 8.

  • Page 22: Infusion Pump With Silicone Specified Infusion Sets

    2.2.4.2 Infusion Pump with Silicone Specified Infusion Sets 1. Connection rail 2. Liquid check clip operating lever 3. Ultrasonic sensor 4. Downstream pressure checkout slot 5. Locating slot 6. Waterproof membrane 7. Upstream pressure checkout slot 8. Liquid check rod 9.

  • Page 23: Infusion Pump With Pvc Specified Infusion Sets

    2.2.4.3 Infusion Pump with PVC Specified Infusion Sets 1. Connection rail 2. Liquid check clip operating lever 3. Ultrasonic sensor 4. Downstream pressure checkout slot 5. Infusion set slot 6. Waterproof membrane 7. Upstream pressure checkout slot 8. Liquid check rod 9.

  • Page 24: Screen Display

    2.3 Screen Display This infusion pump has a built-in LCD screen. The display information comprises three main parts: 1. Title bar Displays current infusion mode, drug information, alarm information, battery icon, and etc. 2. Parameter area Displays every parameter and the parameter value of the current screen. 3.

  • Page 25: Installation And Setting

    Installation and Setting 3.1 Installation WARNING  Equipment assembly and refit (including correct protective grounding connection) during life period must be carried out by maintenance technicians whom are trained and licensed by the manufacturer, and evaluated according to the specified IEC60601-1. Please contact the company if you have any queries.

  • Page 26: Operating Conditions

    WARNING  The packaging materials must be kept out of the reach of children. They must be disposed of in compliance with local laws and regulations or the hospital policy on waste management.  The equipment may be contaminated by microbes during storage, transport and use.

  • Page 27: Mount The Clamp

    3.1.3 Mount the Clamp 1. Align the mounting holes on the installation dead plate with the installation screw holes on the bottom of the machine, and tighten the screws. 2. Turn counterclockwise to loosen the pole clamp until an IV stand can be inserted in.

  • Page 28: Mount The Handle Set

    WARNING  The infusion pump must be installed horizontally. NOTE  Please ensure the stand is stable before installation.  When the pumps are overlapped, all fixing clamps except the fixing clamps of the lowest pump should be removed, otherwise, the pumps can't be used overlapped.

  • Page 29: Connect The Ac Power Source

    NOTE  Only 2 pumps (syringe pump and infusion pump can be cross combined) can be carried by the handle set, or the handle of the handle set might be broken. Please refer to 3.1.4 Multi-channel Pumps Combination for the combination operation of multi-pump. 3.1.6 Connect the AC Power Source To connect the pump to the AC power source, follow this procedure: Always use the accompanying power cord delivered with the pump, and check...

  • Page 30: Install And Operate The Drop Sensor (Optional)

    NOTE  Compatible power supply: 100–240V～, 50/60Hz.  The AC power cable should be correctly inserted and secured into the socket.  Removing power cord is to disconnect equipment from power supply. Please ensure suitable clearance around the device to facilitate connect and remove power cord.

  • Page 31: Conventional Settings

    WARNING  Drop sensor must be installed correctly when the infusion pump is equiped with a drop sensor, otherwise the pump can’t be used normally.  For 60drop/ml infusion sets, it is recommended to set the rate <1000ml/h. Otherwise, the [Empty] alarm will be triggered mistakenly. ...

  • Page 32: Set Language

    3.2.3 Set Language Select [Main Menu]→[User Maintenance]→Input User Maintenance Password→[Language]. Select from the [Language] according to actual needs. 3.2.4 Set Date and Time Select [Main Menu]→[User Maintenance]→Input User Maintenance Password→[Date and Time]. Set [Time] and [Date]. Select [Time format]: [24h] or [12h]. Select [Date format]: [yyyy-mm-dd], [mm-dd-yyyy] or [dd-mm-yyyy].

  • Page 33: Basic Operation

    Basic Operation 4.1 Infusion Flow Chart Turn pump on Press to activate and turn on the pump, the pump will run start-up checks and display the start-up screen; Load infusion set Please refer to 4.2.2 Load the Infusion Set; Select according to the infusion set brand currently Select brand being used;...

  • Page 34: Operational Procedures

    4.2 Operational Procedures 4.2.1 Turn on the Pump To turn on the device, follow this procedure: Perform a safety inspection referring to 11.1 Inspection before turning on the pump. Press , the system will initiate the self-test and the screen will display the [System Self-test] interface: ...
  • Page 35 Load infusion set according to the following method: 1. Pull the door latch up to open the door. 2. Push up the free flow clamp. 3. Load the set, confirm it is firmly loaded into the tube slot, and adjust or press the set at the gray zone, to confirm the set is loaded correctly.

  • Page 36: Infusion Pump With Silicone Specified Infusion Sets

    4.2.2.2 Infusion Pump with Silicone Specified Infusion Sets System will inspect whether the set is loaded after completing the self-test:  If infusion set is not loaded, enter the infusion set [Loading Guide] interface; If the infusion set is not required to load, press to skip the step.

  • Page 37: Infusion Pump With Pvc Specified Infusion Sets

    4. Push the door latch and close the door gently, the system will enter the [Set Selection] interface, indicating that the infusion set is loaded correctly; otherwise, it needs to be reloaded. WARNING  The infusion set should be firmly loaded into the slot, and not jutting on the outside of the slot.

  • Page 38: Change The Infusion Set

    2. Adjust the slide clamp, insert it into the operating lever; load the set, confirm it is firmly loaded into the tube slot, and adjust or press the set at the gray zone, to confirm the set is loaded correctly. 3.

  • Page 39: Infusion Pump With Silicone Specified Infusion Sets

    3. Please refer to 4.2.2.1 Infusion Pump with Conventional Infusion Sets to reload the infusion set. 4.2.3.2 Infusion Pump with Silicone Specified Infusion Sets Follow the steps below to change the silicone specified infusion set: 1. To prevent patient injury due to free flow, before changing the infusion set, please shut down the Robert clip (or flow rate regulator).

  • Page 40: Parameter Memory Function

    CAUTION  Please confirm that the current selected brand is the same as the brand actually used, or its accuracy cannot be guaranteed. 4.2.6 Parameter Memory Function In clinical treatments, the medical staffs need to initiate the infusion as soon as possible during emergency situations, infuse the liquid drug into the patient's body in the shortest time possible, and set the detailed parameters later during infusion.

  • Page 41: Set Infusion Parameters

    NOTE  [Air in line] and [Accumulate air] alarms will not be triggered during purge. 4.2.9 Set Infusion Parameters Under each infusion mode, users can set infusion parameters by pressing 4.2.10 Infusion When ready, connect the infusion set to the patient. Press to start the infusion, and the screen will display the green running icon.

  • Page 42: Bolus

    Press to continue the infusion. 4.2.12 BOLUS In any run screen in the infusion mode, press to enter the [Bolus] settings screen. There are two ways to start the bolus:  Manual Bolus: Set [Bolus Rate], press and hold to manual bolus, and release to return to the original rate.

  • Page 43: Standby

    4.2.15 Standby Under non-running status, press to enter the standby countdown shutdown interface. Press to modify standby time (range is 00:01-99:59 h:min). The pump cannot be put in standby mode if there is a high level alarm. When the standby state is ended, the title bar will display [Standby Time Expired], press to cancel alarm.

  • Page 44: Infusion Mode

    Infusion Mode 5.1 Rate Mode  Unit of Rate (ml/h)  Unit of Rate (gtt/min) Mode Parameters Parameter Range Unit of Rate (ml/h): 0.1-2000ml/h Rate Unit of Rate (gtt/min): 1-(400*Drip/60) gtt/min Rate Mode VTBI 0.1-9999.99ml Time 00:00:01-99:59:59 h:m:s Please refer to 6.6 Drip Setting for the settings of the unit of “gtt/min”.

  • Page 45: Time Mode

    5.2 Time Mode  Unit of Rate (ml/h)  Unit of Rate (gtt/min) Mode Parameters Parameter Range Time 00:00:01-99:59:59 h:m:s VTBI 0.1-9999.99ml Time Mode Rate Same as Rate Mode 5.3 Body Weight Mode 1. Select [Main Menu]→[User Maintenance]→Input User Maintenance Password→[BW Mode Configuration].
  • Page 46 Conc. Configuration: Drug Amount and Volume Configuration: Mode Parameters Parameter Range Weight 0.1-300.0 kg/0.2-660.8 lb Drug amt. 0.1-999.9 Drug amt. unit ng, μg, mg, g, mU, U, kU, EU, mmol, mol, kcal, mEq Volume 0.1-9999.99ml Conc. 0.1-9999 ng/ml, μg/ml, mg/ml, g/ml, mU/ml, U/ml, kU/ml, Conc.

  • Page 47: Sequential Mode

    5.4 Sequential Mode Several different sequences (parameter group) can be set in Sequential Mode, and the infusion pump infuses according to the set infusion sequence. 5 sequences can be set in this mode.The rate of the current sequence can be changed during the operation process.

  • Page 48: Loading Dose Mode

    5.5 Loading Dose Mode Loading Dose Mode infuses [VTBI] of loading dose at the rate of [Loading Rate], then operates at [Main rate] until [VTBI] of the primary parameters is completed. Primary parameters [VTBI] are [Total VTBI]. Mode Parameters Parameter Range Loading dose The same with Rate Loading...

  • Page 49: Ramp Up/Down Mode

    5.7 Ramp Up/Down Mode In Ramp Up/Down Mode, by setting the [Ramp up time] and [Ramp down time], the infusion pump will increase the rate (divided as 9 stages) automatically during the [Ramp up time]until the rate is steady, sustaining for a period of time, and then decrease the rate during the [Ramp down time].

  • Page 50: Setting Parameters

    Setting Parameters 6.1 KVO KVO (Keep Vein Open) means to keep the vein open, during which the infusion pump continues infusion at a very low rate after finishing the infusion in order to prevent blood backflow or vascular occlusion. Select [Main Menu]→[General Options]→[KVO Rate]. Select [KVO Rate]: 0.1-5.0ml/h is adjustable.

  • Page 51: Occlusion Pressure

    6.3 Occlusion Pressure Occlusion pressure is adjustable, which can meet the requirements for occlusion pressure of different patients during infusion. Pressure in the infusion tube can be measured by the built-in pressure sensor, pressure can be calculated by the internal CPU, which is compared with the preset occlusion alarm threshold.

  • Page 52: Dynamic Pressure Scanning (Dps)

    6.3.3 Dynamic Pressure Scanning (DPS) During the infusion, the bottom-right corner of the Run screen demonstrates real-time pressure changes of the patient, in order to find the tube occlusion at an earlier time and to prevent the occurrence of further complications. The pressure icon on the screen indicates the condition of the current pressure: When the progress bar is white, this indicates that the current pressure ◆...

  • Page 53: Accumulate Air

    CAUTION  If the patient experiences discomfort or danger at a higher air bubble filter level, monitor the patient's physical conditions and select the actual needed level. Measures should be taken instantly if any abnormal condition occurs. 6.5 Accumulate Air Select [Main Menu]→[General Options]→[Accumulate air].

  • Page 54: Time Near End

    Select in [Infusion Set] according to actual needs. Note: Please ensure that at least one “Infusion Set” to be selected. Brand and model of silicone specified infusion sets: Type Brand Model Regular Mindray M-IS-0** Regular Mindray M-IS-1** Light-sensitive Mindray M-LS-0**...

  • Page 55: Infusion Pump With Pvc Specified Infusion Sets

    6.10.3 Infusion Pump with PVC Specified Infusion Sets Select [Main Menu]→[User Maintenance]→Input User Maintenance Password→[Infusion Set]. Select in [Infusion Set] according to actual needs. Note: Please ensure that at least one “Infusion Set” to be selected. Brand and model of PVC specified infusion sets: Type Brand Model...

  • Page 56: Other Functions

    Other Functions 7.1 History Record The infusion pump when in use will produce some key data stored in [History Record], providing foundation for the treatment review and maintenance review at a later period. The attribute of recording events includes action, time and description. A record is created once an event occurs.

  • Page 57: Wireless Networking (Optional)

    Normally Open: Select when the hospital call system is set as [NORM. Open].  Alarm level: Three options: [High], [Medium] and [Low].The system sends nurse call signals according to the alarm at the selected alarm level or above. WARNING  Non-medical personnel are forbidden to modify the nurse call setting.

  • Page 58: Data Export

    please refer to the instructions of CIMS. Normal communication of the pump and CIMS depends on whether the network connection is successful, operators are unable to observe the operation status of the pump in real time when the communication is interrupted. After the network connection settings of the pump and CIMS are modified, operators shall reset the network connection as required in the manual to ensure the communication of the pump and CIMS are restored.

  • Page 59: Patient Information

    7.7 Patient Information Infusion pump has been inserted to BeneFusion DS5 Infusion Supervision System and the system contains patient information, the system will automatically distribute patient information to all infusion pumps when pumps are on. Select [Main Menu]→[Patient Information] to view the patient information (Department, Bed No.

  • Page 60: Alarms

    Alarms The alarm is used in order to alert the medical staff by means of sound and light when abnormal situations occur during the infusion procedure which can lead to infusion changes or when the infusion of the patient cannot continue due to the unexpected breakdown or pause/delay of the infusion pump.

  • Page 61: Multi-Level Alarm Rules

    8.2.1 Multi-level Alarm Rules When several alarms occur simultaneously, the alarms proceed according to the following rules:  When several alarms at different levels occur, the visible alarms and audible alarms are consistent with the highest level alarms.  When several alarms at different levels occur, only the highest level alarm is displayed, and after it is cancelled, the lower level alarm will then be displayed.

  • Page 62: Alarm Countermeasures

    8.4 Alarm Countermeasures WARNING  When an alarm is triggered, the patient's condition should be checked firstly and operation should only be allowed to proceed after the reason for the triggering of the alarm is ruled out. When an alarm is triggered, please follow these steps and take appropriate action: 1.

  • Page 63: Battery

    Battery WARNING  The battery can not be disassembled. The battery should be changed by maintenance staff designated by the company only. Changing the battery incorrectly or changing battery by personnel who has not received suitable training may cause such danger as overtemperature, fire or explode.

  • Page 64: Battery Performance Optimization

    When the battery is empty, charging is needed immediately. No battery is installed in the infusion pump. The power supply by the battery can only be sustained for a limited period of time. The [No Battery] alarm will be triggered when the battery voltage is too low, and red alarm light will flash.

  • Page 65: Insert Batteries

    NOTE  The lifespan of the battery depends on how frequently it is used and on how long it has been used.If the maintenance and storage of the battery is appropriate, the lifespan of the Lithium battery is about 5 years.Inappropriate use of the battery will shorten its lifespan.

  • Page 66: Preservation And Sanitation

    Preservation and Sanitation The pump must be cleaned or disinfected using the materials and methods listed in this section. The manufacturer will not be responsible for any damage or accident caused by cleaning and disinfection using other materials and methods. The manufacturer shall not be held responsible for the efficacy of the following chemicals or methods for infection control.

  • Page 67: Disinfection

    To clean your equipment, follow these rules: Turn off the pump and disconnect the AC power source line. Wipe the display screen after soft cotton balls absorb an appropriate amount of detergent. Use a piece of soft cloth which absorbs a modest amount of cleaning agent to wipe the surface of the device.

  • Page 68: Maintenance

    Maintenance WARNING  To avoid electric shock, stop using the device if you find its housing has signs of broken. Contact the service personnel for help in that case.  The hospital or medical facility using this infusion pump must set up a comprehensive maintenance plan.

  • Page 69: Maintenance Plan

    11.2 Maintenance Plan The following tasks must be conducted by professional maintenance personnel approved by the company. Please contact the company if the following maintenances are needed. Must clean and disinfect the device before the test or maintenance. Inspection/Maintenance Items Frequency Once every two years.

  • Page 70: Accessories

    Accessories WARNING  Use the accessories specified in this chapter only. Other accessories may cause damage to this infusion pump, or cannot reach the specification in this manual.  Please do not replace an accessory if its package or itself is damaged. Materials Lithium battery 022-000161-00...
  • Page 71 NOTE  This Operator’s Manual describes the most complete functional configuration of the system. The device you are using may not have some of the settings or functions described herein. 12-2...

  • Page 72: A Product Specifications

    Product Specifications A.1 Safety Specifications A.1.1 Product Classification Classified according to the China SFDA, this infusion pump is a Type II device. Classifications of this infusion pump according to the IEC60601-1 standard are as follows: Safety Components Host Type of protection Class I against electrical shock Degree of protection...

  • Page 73: Operating Environment

    A.1.2 Operating Environment Work environment Temperature 5-40ºC Humidity 15-95%, non-condensing Atmospheric pressure 57-106kPa Storage environment Temperature -20-60ºC Humidity 10-95%, non-condensing Atmospheric pressure 50-106kPa Storage conditions Corrosive-free and ventilated indoors AC Power Supply Voltage 100-240V～ Frequency 50/60Hz Current 0.53-0.28A Fuse Low interrupting rating, T 1A 250V～ External DC power supply Voltage DC 10V-16V...

  • Page 74: Hardware Specifications

    A.3 Hardware Specifications A.3.1 Display Display Type Color LCD Size (diagonal) 3.5 inches, ration 16:9 Differentiation 272 pixels A.3.2 Battery Internal battery No. of batteries Battery type Lithium battery Shutdown delay About 30mins (new battery, after the first low battery alarm) Battery voltage 7.4VDC Battery capacity...

  • Page 75: External Ports

    A.3.5 External Ports Ports AC power supply One AC power supply port port Multifunction One multifunction interface with the following functions:  interface DC power supply port  RS232 interface  Nurse call interface Drop sensor One Drop sensor interface interface (Optional) A.3.6 Signal Output Interface Nurse call signal output...
  • Page 76 other factors. Therefore, infusion sets of different brand and model may differ in maximum rates. Note 2: The above declared rates are based on BOON A2 and B.Braun Intrafix Safeset infusion sets, and specified infusion sets,. temperature of 20±2℃. Bolus Rate/ 0.1-2000ml/h Purge Rate VTBI...
  • Page 77 set and other factors. Therefore, infusion sets of different brand and model may differ in the detected air detection. Note 2: The above declared air detection is based on BOON A2 and B.Braun Intrafix Safeset infusion sets, temperature of 20±2℃. Accumulate air 0.1-4ml 1.5ml...
  • Page 78 Domestic: yyyy-mm-dd Date format: yyyy-mm-dd, mm-dd-yyyy or International: dd-mm-yyyy dd-mm-yyyy You can select language according to Language actual needs Pressure Unit mmHg, kPa, bar and psi mmHg Alarm Sound Sound1, Sound2, Sound3 Sound2 Anti-bolus On, Off switch Drop sensor On, Off Infusion pump with conventional infusion sets: Infusion accuracy of the whole rate ≤±5%...

  • Page 79: A Reference Table Showing Occlusion Alarm Delay And Possible Dose

    A.5 A Reference Table Showing Occlusion Alarm Delay and Possible Dose A.5.1 Infusion Pump with Conventional Infusion Sets Occlusion Pressure Rate Time of Occlusion Alarm (mmHg) (ml/h) (hh:mm:ss) 02:54:30 00:06:07 00:00:30 19:01:01 01:37:08 00:02:00 Rate Pressure Setting Bolus Volume (ml) (ml/h) <0.1 <0.15...

  • Page 80: Infusion Pump With Silicone Specified Infusion Sets

    A.5.2 Infusion Pump with Silicone Specified Infusion Sets Occlusion Pressure Rate Time of Occlusion Alarm (mmHg) (ml/h) (hh:mm:ss) 01:07:08 00:05:02 00:00:30 18:45:50 01:19:12 00:02:50 Rate Pressure Setting Bolus Volume (ml) (ml/h) <0.1ml <0.15ml NOTE  Test conditions:  FLUKE IDA4 PLUS tester ...

  • Page 81: Infusion Pump With Pvc Specified Infusion Sets

    A.5.3 Infusion Pump with PVC Specified Infusion Sets Occlusion Pressure Rate Time of Occlusion Alarm (mmHg) (ml/h) (hh:mm:ss) 02:31:18 00:05:16 00:00:15 23.24.54 01:37:18 00:02:50 Rate Pressure Setting Bolus Volume (ml) (ml/h) <0.1 <0.15 NOTE  Test conditions:  FLUKE IDA4 PLUS tester ...

  • Page 82: Infusion Accuracy Curve And Trumpet Curve

    A.6 Infusion Accuracy Curve and Trumpet Curve The following typical infusion accuracy table expresses performance after infusion has started and infusion fluctuations occurring within a certain period of time after normal infusion flow volumes have been reached. The infusion accuracy table is for reference only, detailed infusion accuracy curve is in accordance with the final device.
  • Page 83  Unit of Rate (ml/h) A-12...
  • Page 84  Unit of Rate (gtt/min) Sampling interval: △t =0.5min Sampling rate: 20gtt/min Test period: t =120mins Infusion rate: Q (gtt/min) Sampling interval: △t =0.5min Sampling rate: 20gtt/min Observation windows: p△t = 2, 5, 11, 19, 31 mins Maximum deviation over the course of a full observation window: Ep(Max) (%) Minimum deviation over the...

  • Page 85: Infusion Pump With Silicone Specified Infusion Sets

    A.6.2 Infusion Pump with Silicone Specified Infusion Sets Plotted on the basis of data collected over a two-hour measurement period. Infusion set brand and model: M-IS-000 Sampling quantity of pump: 3 Sampling interval: △t =0.5min Sampling quantity of infusion set: 3 Test period: t =8h (1ml/h), 72h (25ml/h) Infusion rate: Q (m/h) Sampling interval: △t =0.5min...

  • Page 86: Infusion Pump With Pvc Specified Infusion Sets

    A.6.3 Infusion Pump with PVC Specified Infusion Sets Plotted on the basis of data collected over a two-hour measurement period. Infusion set brand and model: SK ZPQ Sampling quantity of pump: 3 Sampling interval: △t =0.5min Sampling quantity of infusion set: 3 Test period: t =8h (1ml/h), 24h (25ml/h) Infusion rate: Q (m/h) Sampling interval: △t =0.5min...

  • Page 87: B Emc And Radio Regulatory Compliance

    EMC and Radio Regulatory Compliance B.1 EMC The device meets the requirements of IEC 60601-1-2:2014. NOTE  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 88 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 Group 1 The device uses RF energy only for its...
  • Page 89 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 90 power supply or a battery. RATED power 30 A/m 30 A/m Power frequency frequency 50 Hz / 60 Hz 50 Hz / 60 Hz magnetic fields should magnetic fields be at levels IEC 61000-4-8 characteristic of a typical location in a typical commercial or hospital environment.
  • Page 91 9 V/m 9 V/m electromagnetic site survey , should 704–787 MHz, be less than the compliance level in 5100–5800 each frequency range Interference may occur in the vicinity of equipment marked with the following symbol: Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations.

  • 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 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 communication equipment.

  • Page 93: C Alarm Information

    Alarm Information This chapter presents the alarm information of the infusionpump.Prompt information for operation guidance will not be presented in this chapter. The table shows the appropriate countermeasures for each piece of information related to alarm triggering.If the problem still exists after operating according to the countermeasures, please contact the company.
  • Page 94 Alarm Alarm Reason Countermeasure Information Level 1. Only powered with built-in battery, battery is empty. Connect to the AC power [No Battery] High 2. Built-in battery and external source to cancel alarm. DC power encounter failure. 1. Press to cancel alarm.
  • Page 95 Alarm Alarm Reason Countermeasure Information Level 1. Upstream channel has not start infusion or the infusion is unfinished, the communication with BeneFusion DS5 Infusion Supervision System is interrupted; 2. Or the upstream channel has not start infusion or the infusion is unfinished, the Press or insert communication between the...
  • Page 96 Alarm Alarm Reason Countermeasure Information Level acknowledge the alarm condition. 1. The alarm will not be cancelled automatically until the infusion is completed, and then switch to [VTBI Complete] Infusion remaining time or [Empty] alarm. [Time Near End] reaches the setting value of 2.
  • Page 97 Alarm Alarm Reason Countermeasure Information Level 1. Press to stop The alarm is triggered after infusion and cancel alarm. [KVO Running] [VTBI Complete] alarm is 2. Or the [KVO Finish] triggered and in KVO mode. alarm is triggered when reach the KVO infusion time.

  • Page 98: D Symbols And Terms

    Symbols and Terms D.1 List of Units Abbreviation Meaning ampere ℃ centigrade centimeter decibel gram hour hertz inch inch kilo kilogram kilopascal litre pound meter milligrams minute milliliter millimeters mmHg millimeters of mercury second μg Microgram volt volt ampere watt...

  • Page 99: List Of Symbols

    D.2 List of Symbols Symbols Meaning minus percent Per; divide; or ～ power plus ＋ ＝ equal to < less than > greater than ≤ less than or equal to ≥ greater than or equal to plus or minus ± ×...

  • Page 100: List Of Unit Conversion

    Abbreviation Meaning European Economic Community Electromagnetic compatibility Electromagnetic interference C2H4O Intensive Care Unit Identification International Electrotechnical Commission IEEE Institute of Electrical and Electronic Engineers International organization for Standardization Keep vein open Light emitting diode Maximum Medical Device Directive Minimum Magnetic resonance imaging Not applied NICU Newborn Intensive Care Unit...

  • Page 101: E Toxic And Hazardous Substances Or Elements

    Toxic and Hazardous Substances or Elements Cr(VI) PBDE Name of the Parts Cr(VI) PBDE ○ ○ ○ ○ ○ ○ Front housing ○ ○ ○ ○ ○ ○ Back housing Device ○ ○ ○ ○ ○ ○ Keys housing ○ ○...

  • Page 102: F Declaration Of Conformity

    Declaration of Conformity P/N: 046-013877-00 (1.0)

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