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Summary of Contents for Enmind EN-V7 Smart
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USER MANUAL INFUSION PUMP (EN-V7 Smart, EN-V7)
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Preface 1 Application Scope Applicable to EN-V7/EN-V7 Smart infusion pumps of our company. This User Manual describes the product’s most complete configuration, accessories and functions may not exist in the product of the user, for more detailed information, please contact manufacturer.
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5 Description on Revision of User Manual The copyright of this User Manual belongs to Shenzhen ENMIND Technology Co., Ltd. Without permission any institute or individual are prohibited to copy, modify or translate the contents speculated in this User Manual.
Chapter1 Safety Instructions 1.1 Warnings Before using, please check the equipment, connecting wire and accessories to ensure that it can work normally and safely. If there’s anything abnormal, immediately stop working and contact our after sale service department. Additionally, the adhesion or intrusion of fluid/drug may possibly cause the equipment fault and malfunction.
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This equipment injects fluid/drug through extruding the infusion tube, but it can’t detect the leakage if the infusion line is cut off or broken. Therefore, please periodically check it to avoid above fault during the working period. During infusion, please periodically check the dripping state of the fluid and the fluid/drug in the intravenous infusion bag/container, so as to ensure the correct working during infusion.
1.2 Cautions Before its first use after purchase, or this equipment is not used for a long period, please charge the equipment with AC power supply. If it is not fully charged, under power failure, the equipment can’t continue working with built-in battery power supply. ...
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Under the condition of low flow rate infusion, please pay special attention on occlusion. The lower the infusion flow rate, the longer the time of detecting occlusion, and it in turn may possibly cause a long time infusion stop during this period. ...
1.4 Symbols Not all of the below symbols are existed in the equipment you have purchased. Table 1.4-1 Marks Description Marks Description Batch code Protective earth (ground) Drip Proof(Degree of protection Serial number IP24 against ingress of fluids) Caution Alternating current Defibrillation-proof type CF Handle with harmless method applied Part...
Chapter2 Overview 2.1 Application Scope 2.1.1 Expected Purpose The infusion pump is used together with infusion set to control the dose of liquid infused into patient’s body, for example intravenous infusion.. The infusion pump is suitable for adult, children, and newborns in various clinical departments. 2.1.2 Expected Working Environment The infusion pump is expected to be used in institutes or units with healthcare capability.
2.4.3 Description on Model This equipment has two models: EN-V7, EN-V7 Smart, the main function differences are shown in table below. Function /Model EN-V7 EN-V7Smart ml/h mode √ √ Body -weight mode √ √ Drip mode √ √ Loading -dose mode √...
2.5 Product Specification Safety Classification Electric protection Class I Type Electric protection Defibrillation proof type CF applied Part Level Protection against IP24 fluid ingress Working mode Continuous Classification Portable equipment, non-portable infusion pump Specification Parameters Infusion apparatus 20 drops, 60 drops and so on specification System Accuracy ≥1ml/h,±5%...
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DC power supply DC 15V Model: DC 203 Specification: 11.1V 2600mAh Battery Charging time: 5h (under OFF status) Specifications Working time: ≥9h (after completely charging the new battery, when the environment temperature is 25℃ and flow rate is 25ml/h, the constantly working time) Alarm When the sound is set at lowest level, alarm signal sound pressure level...
3.2 Operation Panel ①【Door open】 ②【Stop】 Stop infusion and operation ③【Start】 After setting all parameters, press start to begin infusion. ④ Alarm indicator While pump alarms, indicator light glitters, with different frequency and color, more information please refer to Chapter 9.1 ⑤...
3.3 Display Screen The display screen interface layout composes of title bar and typical interface. 3.3.1 Title Bar Title bar displays real-time state information and is not touchable, the left upper corner displays the name of current editing parameter. Table3.3.1-1: Title Bar Icon Icon Paraphrase Description...
3.3.2 Typical Interface During pre-infusion and infusion, the typical interface will display the following: main interface, working interface, alarm interface, prompt interface, control panel, parameters setting, input method, standby interface etc. 3.3.2.1 Typical Interface Icon Paraphrase Table3.3.2.1-1 Icon Paraphrase Description Start Click this icon, start infusion Stop...
3.3.2.2 Input Method Interface The input method interface composes of the title bar, input box, editing box. Title bar: display the name of current editing parameter. Input box: real-time display the input content. Editing box: It composes of the main button area and function button area. The main button area composes of the numerical value, letters and icons, click it continuously to change the sequence.
3.4 Rear View ① Line clamp Keep the IV line neat② A/C Adapter Port External 100-240V 50/60Hz AC power supply ③ Pole Clamp Using for fixing the equipment on the infusion stand ④ IrDA Using for communicating with EN-D7 Smart workstation(Optional) ⑤...
3.5 Drop sensor (optional) ① Housing ② Slider Push the slider to left direction to adjust the spacing, loosen the slider to automatically return ③ Cable Connectto the equipment drop sensor port...
Chapter4 Installation 4.1 Unpacking and Checking Please check the appearance before unpacking, if broken, please contact the transportation company or our after-sale service department quickly. Please carefully open the package to avoid damaging the equipment and relevant accessories. After unpacking, please check the objects according to the packaging list, if there’re insufficient or damaged accessories, please contact our company as soon as possible.
4.2.1 Install the Infusion Pump (1) Rotate the pole clamp screw(knob) and unscrew to leave the space. (2) Lock the Pole Clamp on the infusion stand, adjust the position of the infusion pump, tighten the pole clamp to fix the infusion pump on the infusion stand (shown in drawing below).
Chapter5 Use Preparation and Cautions 5.1 Use Preparation The new equipment, or reusing after storing for a period, or reusing after repair, please check it to ensure before use: The equipment appearance is clean and under good condition without crack and leakage. ...
Chapter6 Basic Operation 6.1 Operation Flow ¤ Mount the infusion pump on the IV stand ¤ Power on ¤ Install IV Set ¤ Select infusion tube brand or add new brand ¤ Select infusion mode ¤ Set Infusion Parameters ¤ Remove air bubble from the line ¤...
6.2 Infusion Operation 6.2.1 Equipment Installation Mounting the device on the infusion stand according to Chapter 4.2, connect with AC power supply,check the AC indicator lights. 6.2.2 Starting and Self-test Press , power on the equipment. After power on, the system will automatically check the motor, sensor, battery, memorizer, CPU communication, alarm indicator.
Warning: ● It is suggested to use the infusion apparatus of the brand attached with this system. ● Please confirm that the infusion apparatus brand and specification displayed in the display screen is accordant with the actual one. ● Although this equipment supports user-defined infusion apparatus function, in order to ensure the infusion accuracy, the user is strongly suggested to contact our company, and ask the professional technician of our company to set and test the user-defined infusion apparatus.
6.2.7 Changing infusing parameters during infusion Under running interface, click the currently rate number enter parameters setting interface, reset target infusion rate. Note: ●Only the ml/h mode, drip mode and Body weight mode support rate modification function Under running interface, click Menu to enter parameter setting interface, change VTBI, Time, and Reset total volume during infusion.
KVO completion alarm and stop infusion. Please refer Chapter 8.1.2 to set KVO rate. 6.2.10 Stop Infusion During infusion or after infusion, click , infusion stop. The interface display Total Volume Infused and adjustable parameters. 6.2.11 Remove the Infusion Apparatus Disconnect the infusion tube assembly from the patient, click to open the pump door, click the anti-free flow clamp button to open the anti-free flow clamp, and remove the infusion apparatus.
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- Remove the fluid/drug container from the infusion tube assembly. - Connect the infusion tube with the new fluid/drug container. - Restart infusion according to the above steps of replacing infusion tube assembly. Warning: ● The infusion tube will distort if it worked for a long period and may result in flow rate error, it is suggested to replace the pump pressing position or infusion tube assembly after working for 8h.
Chapter7 Set Infusion Parameters 7.1 Introduction to Infusion Parameters Setting (1) The drug information can be displayed in the infusion running interface only when the drug library is under active state. Click『Settings』 icon in the main interface to enter submenu, find 『Drug Library』 menu item, click to enter and select drug(『None』indicate the drug library is off).
VTBI The same as ml/h mode Drip mode Drop rate 1-400 drops/min VTBI The same as ml/h mode Maintain rate Loading dose mode Loading rate Loading time VTBI The same as ml/h mode Ramp up/down Rate mode Rise time Fall time Rate The same as ml/h mode Sequence mode...
7.3.1 ml/h Mode Under this mode, it allows to set three parameters: Rate, VTBI (Volume to be infused) and Time, set any two of the three parameters, and the system will automatically calculate the third parameter, if the VTBI is 0, then the equipment works at the set rate till stop with alarm. 7.3.2 Body- weight Mode Under this mode, set the Weight(body weight), Acti agentia(drug mass), Conc.unit(concentration...
Exmaple: the dose rate unit(ug/kg/min) / min) eight(kg) ose rate ug kg Volume ml rate (ml/h)= flow Acti agentia(mg) 1000 Exmaple: the dose rate unit(mg/kg/h) eight(kg) ose rate mg kg h W Volume ml rate (ml/h)= flow Acti agentia(mg)
time, after reaching the Loading time, it works at the Maintain rate till complete the VTBI(Volume to be infused). Loading dose VTBI =Loading rate ×Loading time Maintain time = (VTBI -Loading VTBI) /Maintain rate Under this mode, set the VTBI, Maintain rate, Loading rate, Loading time, system automatically calculate Loading dose VTBI and Maintain time.
7.3.7 Relay Mode This function is available with the infrared communication function after combining this equipment with EN-D7 Smart infusion workstation made by our company. Please refer to our company “infusion workstation User Manual” for details. 7.3.8 Drug Library Mode 『None』...
ON/OFF state of drug library and select drug. 8.1.1.1 Introduction to Drug library (1) EN-V7 Smart supports over 2000 drug names, which can be imported with external tool, and has the functions such as upper and lower limit, concentration and so on.
8.1.4 Occlusion Pressure Click『Occlusion pressure』to enter into occlusion pressure level setting interface, move the long box to the preset level, after confirming, click『OK』. The higher the level, the higher the occlusion level, it is suggested to select suitable occlusion pressure according to actual requirement. With DPS switch on, line pressure is graphically and dynamically visible during infusing status.
Applicable Model: EN-V7Smart Occlusion Pressure Level: 12 levels Level Pressure Intensity Pressure Intensity Pressure Intensity Pressure Intensity (mmHg) (Kpa) (bar) (psi) 1.45 4.35 7.25 10.15 11.6 13.05 14.5 15.95 17.4 When the line occlusion activates occlusion alarm, the system will automatically trigger anti-bolus function to drop the line pressure and avoid additional impact bolus to the patient after contacting the occlusion.
Air Bubble detector level Alarm Threshold Value Level 1 50ul Level 2 100ul Level 3 200ul Level 4 300ul Level 5 450ul Level 6 600ul Level 7 800ul 8.1.7 Finish Pre-Alarm Time for pre-alarm refers to the time of activating nearing completion alarm when the fluid/drug infused volume is nearly reaching the preset value.
Unit Mark Unit Conversion 1 kPa=7.5mmHg=0.145psi=0.01bar 1psi=51.724mmHg=6.897kpa=0.069bar 1bar=750mmHg=14.5psi=100kPa 8.1.11 Micro Mode Click 『 Micro mode』 to enter into micro mode setting interface. ON/OFF is optional in this function Optional. Under the ON mode, set the rate limit, then the infusion rate under any infusion mode is not allowed to exceed this limit.
8.2 General In the main interface, click『General』to enter into the equipment setting interface. 8.2.1 NetWork This equipment supports wireless or wire interconnection, when it is equipped with wireless module and connects with the internet through WIFI, the equipment screen displays icon.
8.2.2 Sound Click『Sound』to enter into the sound parameters setting interface, the volume has 10 levels. The lowest volume is ≥50dB, and the highest volume is ≤80 dB. Move the long box to the preset level, after confirming, click『OK』. 8.2.3 Date &Time Click『Date &Time』to enter into the date and time setting interface.
8.2.5 Brightness Click 『Brightness』 to enter into display brightness setting interface. The brightness has 10 levels. The equipment has the function of automatic brightness adjustment if external power supply is unavailable. When there is no external power supply, and the power is supplied by battery, if it is not operated within 3min, the system will automatically adjust the brightness to the lowest level, when it is touched or button is clicked by user or when there’s alarm, it will automatically recover the brightness.
8.4 Records 8.4.1 History entries Click 『Records』in the main interface to enter submenu, click the “History entries” menu item into history records query interface. The equipment supports to save over 5000 history records, and can display the event name, event date and time. When it is full, the new records will cover the old records by turn.
8.5.3 SN(Serial Number) Check the serial number of the equipment, and user can’t modify the serial number. 8.5.4 Version Check the software version in this interface. 8.5.5 Maintenance Input password: 2341. More details please refer to Chapter 11 8.6 Electronic Memory Function After turning off the equipment, the electronic memory function can be saved for 5 years at least.
Chapter9 Alarm Prompt and Troubleshooting 9.1 Introduction to Alarm Level During infusion preparation and infusion, this equipment will alarm when reaching or exceeding the set alarm threshold value and prompt with sound, light and text. According to the importance of alarm information as well as the emergency and safety, the alarm is divided into three levels: high, middle and low.
Table9.2-1 Multilevel Alarm Rules Several alarms of different Display the alarms of highest level with sound, light and text, levels generate report middle alarm after eliminating all alarms of highest level simultaneously Several alarms of same level Alarm circularly by turns, the time interval is 3s generate simultaneously 9.3 Alarm Handle Warning ●...
Chapter10 Maintenance 10.1 Cleaning, disinfecting and sterilizing Warning ● Please cut off power supply and unplug the DC /AC power wire before cleaning the equipment. ● During cleaning and disinfecting, please keep the equipment horizontal and upwards to protect the equipment and accessories from fluid. 10.1.1 Cleaning (1) The daily maintenance is mainly to clean the housing and pump body.
similar solvent, otherwise, it may corrode the equipment. 10.2 Periodical maintenance Notes: ● The medical mechanism shall set up complete maintenance plan, otherwise, it may possibly cause the equipment malfunction or fault, and may possibly hurt the physical safety. ● In order to ensure the safe use and prolong the service life of the equipment, it is suggested to periodically maintain and check it once every 6 months.
Maintenance Items Cycle Once every 2 years, please check after Safety check according to IEC60601-1 replacing the printed circuit board assembly or the equipment is dropped or knocked. Once every 2 years, when the occlusion alarm, Preventive system maintenance items (pressure air bubble alarm, or infusion accuracy is doubt calibrate, sensor calibrate, pump) to be abnormal...
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please create the infusion apparatus brand in this interface. Please follow the below steps to add a new brand: Material preparation: Infusion pump, IV tube, measure cylinder, scale balance 1) Click『Brand』, Edit the name. 2) Press ,Page down , Click『Size』, Edit IV tube size 3) Install the IV tube.
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5) Click『 』to start Calibrate 6) After 5mins, the equipment will automatically stop, then record the net weight of fluid by ml; 7) Click 『 』, Input the net weight(ml). 8) Calibration completed. (2) Delete Enter into『Delete』interface, click it to delete user-defined infusion apparatus brand.
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(3)Calibrate Note When first time use pump need calibration When added new brand need calibration When accuracy is not good need calibration. Please calibrate the infusion apparatus when using the built-in brand infusion apparatus for the first time, or the first user-defined infusion apparatus brand, or after periodical maintenance. Please prepare the following materials before calibrating: One new and unused infusion apparatus, 20ml measuring cup or 20ml injector.
6) Click 『 』Input the net weight(ml). 7) Calibration completed. 10.4 Repair 10.4.1 Normal Repair Process Please contact our company or authorized service personnel to repair if there’s any fault, do not disassemble and repair the equipment. After repair, please perform overall test for the equipment. Our company may provide the circuit diagram and components list to the authorized repair technician if needed.
10.5 Equipment Components/Accessories Warning: ● Only the components and accessories designated by our company shall be adopted, otherwise, it may possibly damage the equipment or drop the equipment performance. During the normal service life of the equipment, the battery is consumable, it is suggested to replace them once every 2 years, please contact the dealer or our company to replace them.
Chapter11 Battery This equipment is equipped with rechargeable lithium-ion polymer battery to ensure the normal infusion when the equipment is moved or the external power supply is cut off. When connecting external power supply, no matter the equipment is power on or not, the battery is charged.
For the damages or faults mentioned above, our company provides repair services but charge at repair cost. Manufacturer: Shenzhen Enmind Technology Co., Ltd. Room 201,Block A,No.1,Qianhai Road 1,Qianhaishen Port Cooperative District, Shenzhen, 518000,Guangong,China Site included: 5th Floor, Block A, Defengsheng Building, No.41 Dabao Road, Bao'an District 23, Shenzhen, 518101, P.R.China...
Chapter13 Appendix Appendix A Start Up Graphs and Trumpet Curves Appendix A.1 Start-up Graphs Brand and specification of infusion set: Jierui(20 drops) Flow Rate: 1ml/h Measurement Interval: ∆ t = 0.5min Measurement duration: T = 2h Graph 1 Start-up graph: Flow rate 1 (ml/h) against time (min) plotted from data gathered during the first 2 h of the test period Brand and specification of infusion set: Jierui (20 drops) Flow Rate: 25ml/h...
Appendix A.2 Trumpet Curves Brand and specification of infusion set: Jierui (20 drops) Flow Rate: 1ml/h Measurement Interval: ∆ t = 0.5min Measurement duration: T = 2h Graph 3 Trumpet curve: Percentage variation Ep against observation window duration P (min) and the overall mean percentage error A plotted from data gathered during the second hour of the test period Brand and specification of infusion set: Jierui (20 drops) Flow Rate: 25ml/h...
High 0h 1min 29sec 0.126 Notes: The alarm pressure intensity error for EN-V7 Smart is ±15% or ±100mmHg, the higher value shall be taken; The alarm pressure intensity error for EN-V7 is ±20% or ±150mmHg, the higher value shall be taken.
Appendix C Alarm and Solution Alarm Type Alarm Reason Solution Level The preset value infusion Press 【 Stop 】 button to stop VTBI infused High Completion. alarm. Manually solve the problem of Line occlusion during occlusion, Press【Start】 button infusion. to continue infusion. 2.
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Alarm Type Alarm Reason Solution Level Press 【 Stop 】 button to stop alarm, disconnect the line from the patient, eliminate the air Air bubble High Air bubble in the infusion line. with purge function, or open the infusion pump door to manually remove the air bubbles.
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Alarm Type Alarm Reason Solution Level When turning on the drop Drop sensor sensor, the equipment is not Connect the drop sensor, or turn connection connected with drop off the drop sensor in the menu. sensor. Under ON state, AC power alarm automatically supply is adopted, but the AC...
Appendix D EMC Electro Magnetic Compatibility declaration This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment. Cautions: ...
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Guidance and manufacture’s declaration – electromagnetic immunity The Infusion pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Infusion pump should assure that it is used in such an environment. Electromagnetic environment Immunity test IEC 60601 test level Compliance level...
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Power frequency Power frequency magnetic (50Hz/60Hz) fields should be at levels magnetic field characteristic of a typical 3 A/m 400A/m IEC 61000-4-8 location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. Guidance and manufacture’s declaration –...
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transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b 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.
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Recommended separation distances between portable and mobile RF communications equipment and the Infusion pump . The Infusion pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Infusion pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Infusion pump as recommended below, according to the maximum output power of the communications equipment.
Appendix E Wireless Module Information Parameter Name Parameter Value Frequency Range 2.412GHz-2.482GHz Modulating Type OFDM, CCK, DSSS Effective Radiating <20dBm Power...
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