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Related Manuals for Enmind EN-S7 Smart
Summary of Contents for Enmind EN-S7 Smart
- Page 1 USER MANUAL SYRINGE PUMP (EN-S7 Smart, EN-S7)
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Page 3: Applicable Object Of The User Manual
Preface 1 Application Scope of the User Manual Applicable to EN-S7/EN-S7 Smart syringe 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. -
Page 4: Description On Revision Of User Manual
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. -
Page 5: Table Of Contents
Content 1 Application Scope of the User Manual ..................... 1 2 Applicable Object of the User Manual ..................... 1 3 Use Instructions ............................1 4 Paraphrase ..............................1 5 Description on Revision of User Manual ....................2 Chapter1 Safety Instructions ......................... 4 1.1 ... - Page 6 Chapter6 Basic Operation ........................24 6.1 Operation Flow ..........................24 6.2 Infusion Operation ........................25 6.2.1 Equipment Installation ......................25 6.2.2 Starting and Self-test ......................25 6.2.3 Install Syringe ........................25 6.2.4 Set Infusion Parameters ......................25 6.2.5 Remove Air bubble ........................ 25 6.2.6 ...
- Page 7 8.1.10 Micro Mode ........................... 36 8.1.11 Commonly used syringe brand ....................36 8.1.12 Reset Total Volume ........................ 37 8.2 General ............................37 8.2.1 NetWork ..........................37 8.2.1.1 Connection Mode ......................37 8.2.1.2 Relay ..........................37 8.2.1.3 WLAN ........................... 37 8.2.2 Sound .............................
- Page 8 10.2 Periodical maintenance ....................... 45 10.2.1 Check the Appearance ......................45 10.2.2 Performance Check ....................... 45 10.2.3 Maintenance Plan ........................45 10.3 Add new brand and Calibration ....................46 10.4 Repair ............................51 10.4.1 Normal Repair Process ......................51 10.4.2 Maintenance for Long Term Store ..................
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Page 9: Chapter1 Safety Instructions
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. - Page 10 doesn’t alarm for a long period if the actual occlusion pressure is lower than the alarm threshold value, therefore, please periodically check the puncturing part. If there’s any abnormal phenomenon for the puncturing part, please timely take suitable measures, such as puncturing again. ...
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Page 11: Cautions
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. ... -
Page 12: Dialogue Window
1.3 Dialogue window Dialogue window mainly content include operation select, operation confirm etc. tips information. For instance: (Figure1.3-1: Operation select window) (Figure1.3-2: Operation confirm window) -
Page 13: Symbols
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... -
Page 14: Chapter2 Overview
Chapter2 Overview 2.1 Application Scope 2.1.1 Expected Purpose The syringe pump is used together with syringe to control the dose of liquid infused into patient’s body, for example intravenous infusion. 2.1.2 Expected Working Environment The syringe pump is expected to be used in institutes or units with healthcare capability. Including but not limited to: outpatient department, emergency department, wards, ICU (intensive care unit), NICU (neonate intensive care unit), operating room, observation room, clinics and nursing home. -
Page 15: Description On Model
2.4.3 Description on Model This equipment has two models: EN-S7, EN-S7 Smart, the main function differences are shown in table below. Function /Model EN-S7 EN-S7Smart ml/h mode √ √ Body weight mode √ √ TIVA mode √ Loading- dose mode √... -
Page 16: Product Specification
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 operation Classification Portable equipment, non-portable syringe pump Specification Parameters Compatible Syringes 5ml, 10ml, 20ml, 30ml , 50/60ml System Accuracy ≥1ml/h, ±2% ( mechanical accuracy ±1% ) Syringe size 5ml: (0.01-100) ml/h... - Page 17 Infused Time Range 1min-99hrs59min Fuse Type T2AL 250V 280(W)*95(D)*120(H) mm (without cover) Dimensions 400(W)*95(D)*120(H) mm (with cover) Weight Approx. 1.7kg Power Supply AC power supply 100-240V 50/60Hz Input power 50VA DC power supply DC 11-16V Model: DC 203 Specification: 11.1V 2600mAh Battery Charging time: 5h under OFF status Specifications...
- Page 18 Safety Standard IEC 60601-1:2005+A1:2012 Medical Electrical Equipment, Part 1: General Requirements for basic safety and essential performance IEC60601-2-24:2012 Medical electrical equipment – Part 2-24: Particular requirements for the safety o f syringe pumps and controllers IEC60601-1-8：2006+A1：2012 Main Safety Medical electrical equipment –Part 1-8: General requirements for basic safety an Standards d essential performance –Collateral Standard: General requirements, tests and gui dance for alarm systems in medical electrical equipment and medical electrical sy...
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Page 19: Chapter3 Appearance
Chapter3 Appearance 3.1 Left Front View ① Handle Control syringe pump push-pull sliding box and clip. ② Slider box ③ Syringe clip Clamp the syringe plunger. ④ Lead-screw ⑤ Syringe fixture lever Pull forward then turn right, install the syringe into the slot. ⑥... -
Page 20: Right Front View
3.2 Right Front View ① Syringe fixture lever ② Flange plate Pull the fixture lever, put the syringe flange into the slot. -
Page 21: Operation Panel
3.3 Operation Panel ① 【Fn】For future option 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 9.1 ⑤... -
Page 22: Display Screen
3.4 Display Screen The display screen interface layout composes of title bar and typical interface. 3.4.1 Title Bar Title bar displays real-time state information and is not touchable, the left upper corner displays the name of current editing parameter. Table3.4.1-1: Title Bar Icon Icon Paraphrase Description... -
Page 23: Typical Interface
3.4.2 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. 3.4.2.1 Typical Interface Icon Paraphrase Table:3.4.2.1-1 Icon Paraphrase Description Start Click this icon, start infusion Stop... -
Page 24: Input Method Interface
3.4.2.2 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. -
Page 25: Rear View
3.5 Rear View ① IV tube clamp Keep the syringe extension tube in line and neat ② A/C Adapter Port External 100-240V 50/60Hz AC power supply ③ Pole Clamp Using for mounting the equipment on the infusion stand ④ IrDA Using for communicating with EN-D7 Smart workstation(Optional) ⑤... -
Page 26: Chapter4 Installation
Installation Chapter4 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. -
Page 27: Install The Syringe Pump
4.2.1 Install the syringe 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 syringe pump, tighten the pole clamp to fix the syringe pump on the infusion stand (shown in drawing below). -
Page 28: Chapter5 Use Preparation And Cautions
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. ... -
Page 29: Chapter6 Basic Operation
Chapter6 Basic Operation 6.1 Operation Flow 1. ¤ Mount the syringe pump on the IV stand 2. ¤ Power on 3. ¤Install syringe 4. ¤ Select syringe brand or add new brand 5. ¤ Select infusion mode 6. ¤ Set infusion Parameters 7. -
Page 30: Infusion Operation
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. -
Page 31: Start Infusion
purge icon ,eliminate the air bubble in the line . The purge total volume is not calculated in the Total Volume Infused. Cautions: ● Before purge air, pls. confirm the infusion line is not connected with the patient. ● Purge rate is the max rate of the syringe size, when purge volume ≥5ml, purge will automatically stop. -
Page 32: Infusion Completion
6.2.9 Infusion Completion When infusion near completion, pump will alarm. If ignore it, the system will keep alarming until finishing infusion. After VTBI completed, it activates VTBI infused alarm, if KVO function is ON, the equipment automatically starts KVO function, click 『OK』 in the alarm interface to stop KVO and eliminate alarm. -
Page 33: Chapter7 Set Infusion Parameters
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 sub-menu, find 『Drug Library』menu item, click to enter and select drug(『None』indicate the drug library is off). -
Page 34: Infusion Mode Setting
Acti agentia(Drug mass), Concentration unit Volume(Fluid amount) Weight, Loading rate, The same as Body Weight mode TIVA mode Loading rate Unit. Loading time, Maintaining dose, Maintain dose unit, Dose Unit, VTBI The same as ml/h mode Maintain rate Loading dose mode Loading rate Loading time... -
Page 35: Ml/H 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), Conc.unit(concentration unit), Acti agentia(drug... -
Page 36: Tiva Mode
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) -
Page 37: Sequence Mode
within the set rise time of the equipment through setting the rise time and fall time, after holding for a period, it automatically drops the flow rate within the set fall time. The rising or dropping stage is implemented in 9 stages. Under this mode, set VTBI, rate in the stable stage, rise time and fall time, the system will automatically calculate the rising and dropping rate. -
Page 38: Chapter8 System Setting
ON/OFF state of drug library and select drug. 8.1.1.1 Introduction to Drug library (1) EN-S7 Smart supports over 2000 medicines, which can be imported with external tool, and has the functions such as upper and lower limit, concentration and so on. -
Page 39: Occlusion Pressure
8.1.4 Occlusion Pressure Click 『Occlusion pressure』 to enter into occlusion 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. -
Page 40: Dps(Dynamic Pressure System)
Applicable Model: EN-S7 Smart 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. -
Page 41: Weight Unit
8.1.8 Weight Unit Click 『Weight unit』 to enter into the body weight unit setting interface, click preset body weight unit option, then the corresponding icon of this option changes into Note: ● The current software version only support unit kg. 8.1.9 Pressure Unit Click 『Pressure unit』to enter into pressure unit select setting interface, four units are available: mmHg, kPa, bar, psi, click the preset unit option. -
Page 42: Reset Total Volume
8.1.12 Reset Total Volume Click『Reset total volume』, the interface displays the operation confirming prompt box, click 『Yes』to confirm reset, otherwise, please click『No』 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. -
Page 43: Sound
company. ● The transmitted data of this equipment doesn’t provide any suggestion on therapy, and this data shall not be used for calculating the therapeutic schedule. ● When the data is adopted by the third party’s equipment or software, it is only for displaying, and shall not be used for alarming or calculating. -
Page 44: Brightness
After turn on 『Screen lock』function during infusing，press『Power』key to lock or unlock the device manually. Unlock: press any keypad, or click the screen, a reminder of unlock will be popped out, click 『OK』. Note: ● The equipment will automatically unlock if there’s high Level alarm. 8.2.5 Brightness Click『Brightness』to enter into display brightness setting interface. -
Page 45: Patient
8.3 Patient Click『Patient』in the main interface to enter into setting interface. 8.3.1 Patient Information Click『Patient』to enter into the patient information setting interface and set bed number, MRN, name, gender, age, body weight, height. 8.3.2 Prescription Click『Patient』to enter into the patient information setting interface and enter the end of the sub menu, find menu item 『Prescription』and enter to set the medical advice ID, medical advice information, start time and state. -
Page 46: Clear All Records
8.4.4 Clear all records Click 『Clear all records』to clear all history records and therapy records. 8.5 System Click『System』under the menu interface, enter the system information setting interface 8.5.1 Language This equipment supports simplified Chinese, English,Spanish etc.Click『Language』to change device language. 8.5.2 Factory Default Click『Factory default』to clear the User defined option, and this function is open to the user. -
Page 47: Chapter9 Alarm Prompt And Troubleshooting
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. -
Page 48: Multi-Level Alarm Rules
9.2 Multi-level Alarm Rules When there’re several alarms, the system will alarm according to the following rules: Multilevel Alarm Rules Several alarms of different Display the alarms of highest level with sound, light and text, levels generate simultaneously report middle alarm after eliminating all alarms of highest level Several alarms of same level Alarm circularly by turns, the time interval is 3s... -
Page 49: Chapter10 Maintenance
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. -
Page 50: Periodical Maintenance
Warning: ● Please do not adopt Cidex OPA orthophthalaldehyde, methyl ethyl ketone or 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. -
Page 51: Add New Brand And Calibration
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. Preventive system maintenance items (pressure Once every 2 years, when the occlusion alarm, calibrate, sensor calibrate, pump) or infusion accuracy is doubt to be abnormal Using the equipment for the first time, syringe... - Page 52 2) Click『Size』, Select syringe size. 3) Install syringe, pull the syringe piston beyond size scale line a little, press and hold on 【bolus】, push the piston to the corresponding size line. 4) Press 【start】, begin calibration, wait the calibration done.
- Page 53 5) Repeat above step 2~step 4, complete the new brand other size parameters 6) Press ，page down, find those different size syringe technical parameters, “Out diameter”, “Full range length”, “Empty Space”, manually input the parameters to other same syringe pumps after edit name (2) Delete brand Enter into『Delete』interface, click it to delete user-defined syringe brand.
- Page 54 (3) Calibration Note When first time use pump need calibration When added new brand need calibration When accuracy is not good need calibration. Calibrating Steps: Automatic: 1) Select syringe brand. 2) Select syringe size. 3) Install syringe, pull the syringe piston beyond size scale line a little, press and hold on 【bolus】, push the piston to the corresponding size line.
- Page 55 5) Calibration completed. Manual: 1) Select syringe brand. 2) Select syringe size. 3)Turn down to the second page. 4)Click to Input “ ”, “ ”, “ ” parameters. 5)Calibration completed.
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Page 56: Repair
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. -
Page 57: Recycling
10.7 Recycling The normal service life of this equipment is 5 years, and depends on the use frequency and maintenance. The equipment must be rejected after reaching the service life, please contact the manufacturer or the dealer to get more detailed information. 1. -
Page 58: Chapter11 Battery
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. -
Page 59: Chapter12 After Sale Service
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... -
Page 60: Chapter13 Appendix
Chapter13 Appendix Appendix A Start Up Graphs and Trumpet Curves Appendix A. 1 Start-up Graphs Brand: Double-Dove Size:50ml 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: Double-Dove Size:50ml Flow Rate: 5ml/h... - Page 61 Appendix A.2 Trumpet Curves Brand: Double-Dove Size:50ml 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: Double-Dove Size:50ml...
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Page 62: Appendix B Occlusion Response Property
Appendix B Occlusion Response Property EN-S7 Smart Delay and Possible Dose Flow Rate Max bolus Occlusion Pressure Time to occlusion alarm(min) (ml/h) (ml) (mmHg) 0h22min40sec 0.046 2h20min0sec 0.109 High 0h11min55sec 0.053 High 0h29min43sec 0.086 EN-S7 Delay and Possible Dose Flow Rate... -
Page 63: Appendix C Alarm And Solution
Appendix C Alarm and Solution Alarm Type Alarm Level Reason Solution The preset value infusion Press【Stop】button to stop VTBI infused High Completion. alarm. Press 【Stop】 button to The liquid medicine in the stop the alarm. Syringe empty High syringe is empty. 1. - Page 64 Alarm Type Alarm Level Reason Solution During infusion, This alarm can’t remaining time of preset eliminated, and waits till VTBI near end Middle value reaches or is less infusion completes. than nearing completion time. The syringe is near empty This alarm status which is calculated eliminated,...
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Page 65: Appendix D Electro Magnetic Compatibility Declaration
Appendix D 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. Caution: ... - Page 66 Guidance and manufacture’s declaration – electromagnetic immunity The Syringe pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Syringe pump should assure that it is used in such an environment. Electromagnetic Immunity test IEC 60601 test level Compliance level environment - guidance...
- Page 67 Power frequency 3 A/m 400A/m Power frequency magnetic (50Hz/60Hz) magnetic fields should be at levels field IEC 61000-4-8 characteristic of a typical 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 –...
- Page 68 Field strengths from fixed RF 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.
- Page 69 Recommended separation distances between portable and mobile RF communications equipment and the Syringe pump . The Syringe pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Syringe pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Syringe pump as recommended below, according to the maximum output power of the communications equipment.
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Page 70: Appendix E Wireless Module Information
Appendix E Wireless Module Information Parameter Name Parameter Value Frequency Range 2.412GHz-2.482GHz Modulating Type OFDM, CCK, DSSS Effective Radiating Power < 20dBm... -
Page 71: Appendix F Factory Default Data Set
Parameters Default Setting Parameters Default Setting KVO rate 1ml/h Sound Occlusion pressure 450mmHg Screen lock Finish pre-alarm 2min Brightness Reminder alarm 2min Night mode Pressure unit mmHg Nurse call Micro mode Drug Library Commonly used Enmind Relay mode syringe brand... - Page 72 ...
- Page 73 V 2.3...
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