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MEDCAPTAIN SYS-50 Operation Manual

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SYS-50/52 Syringe Pump
Operation Manual
Please read this "Operation Manual" carefully and follow "Precautions for Use" before using
the SYS-50/52 Syringe Pump.
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

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Summary of Contents for MEDCAPTAIN SYS-50

  • Page 1 SYS-50/52 Syringe Pump Operation Manual Please read this “Operation Manual” carefully and follow “Precautions for Use” before using the SYS-50/52 Syringe Pump. MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
  • Page 2 Statements MEDCAPTAIN reserves the right for final interpretation of this Operation Manual. MEDCAPTAIN reserves the right to modify the contents of this operation manual for a more accurate and effective service quality. The modified contents should be reflected in the newly published operation manual version.
  • Page 3 Intellectual Property and Statement V1.5  Added the description that the sound of the Battery Empty alarm cannot be paused and the sound of a low-level alarm can be paused.  Issued on: 2020-02 V1.6  Changed the parameters.  Software: V2 ...

  • Page 4: After-Sale Service

    After-Sale Service Thank you for using the syringe pump of MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.  During the warranty period, we provide free after-sale services except repairs due to the following causes:  Artificial damage.  Inappropriate use.  The voltage of supply network exceeds the prescribed range.
  • Page 5 Preface Illustrations All the illustrations provided in this operation manual are for your reference only. The settings or data on the illustrations may differ from the actual settings or data of the product. Conventions  Italics: Indicates the quoted content. ...

  • Page 6: Table Of Contents

    ................1 ONTRAINDICATION ................1 RODUCT EATURES PRECAUTIONS FOR USE ..............3 PRODUCT SPECIFICATIONS............8 PRODUCT DESCRIPTION ............... 12 ............... 12 PERATING RINCIPLE SYS-50........... 12 OMPOSITION OF YRINGE SYS-52 ........... 14 OMPOSITION OF YRINGE ..................16 LAMP ................... 18 URSE AGER ............
  • Page 7 Contents ..................27 UNCTURE ................27 TARTING NFUSION ............. 27 HANGING URING NFUSION ....................28 OLUS 6.10 S ................29 TOPPING NFUSION 6.11 R ................30 EPLACING YRINGE 6.12 P ..............30 OWERING FF THE SETTING THE SYRINGE PUMP ............31 ................
  • Page 8 Contents ..................42 ATIENT ..............43 UILT ATTERY ONNECTING TO THE NFUSION ENTRAL ONITORING YSTEM ) ....................44 PTIONAL ) ..............44 URSE AGER PTIONAL LAN(O ) ............44 ONNECT TO PTIONAL ) ..............44 IBRARY PTIONAL TROUBLESHOOTING ..............45 ....................
  • Page 9 Contents ........53 NVIRONMENTAL ROTECTION AND ECYCLING FLOW RATE CHARACTERISTICS ........... 54 10.1 F ............54 HARACTERISTICS 10.2 O ............56 CCLUSION HARACTERISTICS APPENDIX A ELECTROMAGNETIC COMPATIBILITY (EMC) ....57 APPENDIX B DEFAULT FACTORY SETTINGS .......... 61 APPENDIX C PARAMETER UNITS ............62...

  • Page 10: Overview

    1.2 Contraindication None. 1.3 Product Features MEDCAPTAIN SYS-50/52 is a micro-volume continuous-operation syringe pump. It ensures constant infusion rate and accurate dosing volume during prolonged infusion. This syringe pump is used for continuous and micro-volume infusion of liquid or...
  • Page 11 Overview  Three types of power supply are supported: AC power supply, DC power supply, and internal lithium battery.  Double/quadruple CPU, and redundancy design for key units, which will protect the patient from over-infusion and under-infusion.  Two-way alarm for monitoring the main control circuit and motor drive circuit. ...

  • Page 12: Precautions For Use

    Precautions for Use 2 Precautions for Use In this manual, precautions are classified into warning and caution paragraphs according to their importance. The meanings are as follows: WARNING: The information is about safety and efficiency. Operation against the precautions may cause injuries.
  • Page 13 Precautions for Use  Only the syringe, tube, syringe needle and other medical parts complying with local regulations can be used on the syringe pump. Contact your local distributor for more information.  Operating the syringe pump against the requirements, procedures, warnings or cautions provided in this manual may cause infusion failure, inadequate or excessive dosing, and/or other potential risks.
  • Page 14 (including syringe model, infusion flow, serial number of syringe pump, and type of infusion liquid) to your local distributor or MEDCAPTAIN’s customer service department.  Do not disassemble or reconstruct the syringe pump.
  • Page 15 Precautions for Use  The mean delay time from the onset of the ALARM CONDITION to the point that the representation of the ALARM CONDITION leaves the SIGNAL INPUT/OUTPUT PART is about 3.1s.  After the pump is exposed to a defibrillation voltage, the recovery time of the pump is shorter than 1s (the pump functions properly during exposure to the defibrillation voltage).
  • Page 16 Precautions for Use ON/OFF HOME Nurse call Protective earth. USB interface. This way up Fragile, handle with care Keep dry Keep away from sunlight Atmospheric pressure limitation Temperature limit Humidity limitation Stacking limit by number (n is 5, 7…, for the specific value, see the product package box.) 7/ 62...

  • Page 17: Product Specifications

    Product name Syringe pump/Dual-channel syringe pump Model SYS-50/SYS-52 AC power supply: SYS-50: AC 100-240V,50/60 Hz, 40 VA input power SYS-52: AC 100-240V,50/60 Hz, 60 VA input power External DC power supply: SYS-50: DC 12 V, 1.5A SYS-52: DC 12 V, 3.0A...
  • Page 18 Product Specifications All syringes of 5ml, 10ml, 20ml, 30ml, and 50/60ml conform to Compatible syringes the standard. Rate mode,Time mode,Weight mode, Sequence mode, Infusion mode Loading Dose mode, Trapezia mode, Micro mode, TIVA mode, and RELAY mode (only for SYS-52) 0.10-100.0ml/h(5ml syringe) 0.10-300.0ml/h(10ml syringe) 0.10-600.0ml/h(20ml syringe)
  • Page 19 Product Specifications Bolus operation 0.10-100.0ml/h(5ml syringe) 0.10-300.0ml/h(10ml syringe) 0.10-600.0ml/h(20ml syringe) 0.10-900.0ml/h(30ml syringe) 0.10-2000ml/h(50/60ml syringe) Automatically calculate the bolus rate by bolus amount, cannot be lower than the current rate. Bolus VTBI 0.10-5.00ml(5ml syringe) 0.10-10.00ml(10ml syringe) 0.10-20.00ml(20ml syringe) 0.10-30.00ml(30ml syringe) 0.10-50.00ml(50ml/60ml syringe) Time 00:00:01-99:59:59 (minimum increment: 1s) Alarm...
  • Page 20 5. Not category AP/APG equipment; 6. Mode of operation: continuous Dimensions SYS-50: 362 x 126 x 151 mm (L x W x H) SYS-52: 366 x 148 x 216 mm (L x W x H) Weight SYS-50:About 1.8 kg (standard configuration) SYS-52:About 3.0 kg (standard configuration)

  • Page 21: Product Description

    Product Description 4 Product Description 4.1 Operating Principle The SYS-50/52 syringe pump mainly consists of the pump shell, display and operating system, monitoring system, alarm system, motor drive system, drive module, power supply system, WIFI communication module (optional), LAN communication module, and pole clamp (optional).
  • Page 22 Product Description 1 - Clutch 2 - Slider 3 - Syringe clamp 4 - Floor mat 5 - Threaded hole 6 - Label 7 - External inlet 8 - AC power inlet 9 - Back housing 1 -Tube clamp 2 - Floor mat 3 - Buzzer 13/ 62...

  • Page 23: Composition Of Syringe Pump Sys-52

    Product Description 4.3 Composition of Syringe Pump SYS-52 1 - Clamp 2 - Syringe fixation 3 - Slider 4 - Clutch 5 - Operation button 6 - Touchscreen 7 - Alarm indicator 8 - Tube clamp 9 - Front housing 1 - Clutch 2 - Slider 3 - Syringe clamp...
  • Page 24 Product Description 7 - External inlets 8 - AC power inlet 9- Back housing 1 - Tube clamp 2 - Floor mat 3 - Buzzer CAUTION:  Additional equipment connected to medical electrical equipment through the network/data coupling (USB or LAN port) must comply with the respective IEC or ISO standards (e.g.

  • Page 25: Pole Clamp

    1 - Mounting knob of infusion stand 2 - Mounting screw 3 - SYS-50 pump 4 - Drip stand 5 - Pole Clamp Installation method depicted above: 1. Affix the mounting screw (2)into the threaded hole in the back of SYS-50 pump. 16/ 62...
  • Page 26 5 - Pole Clamp Installation method depicted above: 1. Affix the mounting screw (2) into the threaded hole in the back of SYS-50/52 pump. 2. Hold the handle, and affix the pump to the drip stand (4) by tightening the mounting knob of infusion stand(1).

  • Page 27: Nurse

    Product Description 4.5 Nurse Pager 1 - Button 2 - Cable 3 - Socket 4.6 Accompanying Accessories 1 - AC power cable x 1 2 - Pole clamp x 1 3 - Operation manual x 1 4 - Quick operation guide x 1 5 -Packing list x 1 4.7 Optional Accessories Table 4-1 List of Optional Accessories...

  • Page 28: Preparations For Use

    Preparations for Use 5 Preparations for Use  Before using the syringe pump, read the operation procedures and precautions in this manual carefully.  Before using the syringe pump for the first time, set the date and time to ensure that the pump history will be recorded correctly.

  • Page 29: Operating Instructions

    Operating Instructions 6 Operating Instructions 6.1 Display and Buttons  Display of SYS-50 1 - Alarm indicator 2 - TFT touchscreen 3 - ON/OFF button 4 - Indicator 5 - Home button 6 - Logo 7 - Product model 8 - Operation instruction ...
  • Page 30 Operating Instructions 1 - Alarm indicator 2 - Touchscreen 3 - ON/OFF button 4 - Indicator 5 - Home button 6 - Logo 7 - Product model The alarm indicator indicates alarms in two colors: red and yellow. This indicator indicates the alarm severity (high, medium, or low) by using different blinking methods.
  • Page 31 Operating Instructions External power source symbol. This symbol is displayed when the pump is connected to an external AC/DC power source. Screen lock symbol. Two states exist: lock and unlock. Battery volume and charging status. Four bars in total. A large number of illuminated bars indicates a higher remaining capacity.

  • Page 32: Powering On The Pump

    Operating Instructions return to the infusion preparation screen, press [HOME] once again on any setting interface.  [ON/OFF]: Button for switching on/off the pump. When the pump is off, press [ON/OFF] to switch it on. When the pump is on, press [ON/OFF] and tap the shutdown button on the display to shut down the pump or press and hold [ON/OFF] for 3 seconds to shutdown the pump forcibly.

  • Page 33: Syringe Installation

    Operating Instructions 6.3 Syringe Installation  Pull the clamp and turn it rightwards (①/②)  Press the clutch and move the slider fully to the right.  Attach the syringe. Insert the flange of the syringe into the slit (③) Press the clutch, and move the slider until the contact pin of the slider hits the syringe plunger.

  • Page 34: Purging

    Operating Instructions WARNING  Ensure that no air bubble exists in the syringe.  If the syringe flange is not properly installed in the slit, flow rate accuracy and alarm function cannot be guaranteed. 6.4 Purging WARNING:  After installing a syringe on the syringe pump, remove the air bubbles from the syringe IV line.

  • Page 35: Setting The Infusion Rate

    Operating Instructions 300.0 600.0 900.0 50/60 2000 CAUTION:  When high viscosity IV fluids are infused through a thin vein needle for purging, an occlusion alarm may be generated. In this case, please reduce the infusion rate manually.  The volume used for purging will be added to the total volume delivered. ...

  • Page 36: Puncture

    Operating Instructions Table 6-2 Relationship between syringe size and rate Syringe size (ml) Setting range (ml/h) 0.10-100.0 0.10-300.0 0.10-600.0 0.10-900.0 50/60 0.10-2000 Table 6-3Relationship between rate range and the minimum increment Rate range(ml/h) Minimum increment(ml/h) 0.10 - 99.99 0.01 100 - 999.9 1000 - 2000 CAUTION: ...

  • Page 37: Bolus

    Operating Instructions  After entering the rate and tapping [Confirm], the system returns to the original infusion interface and operates at the new rate; if you tap [Cancel], the system returns to the original infusion interface without change. CAUTION:  If no operation is performed on the reference or rate setting interface for more than 10 seconds, the system returns to the infusion interface automatically.

  • Page 38: Stopping Infusion

    Operating Instructions  Choose “Automatic Bolus”, during infusion; tap [Bolus] to enter the bolus setting interface. Set any two of Bolus VTBI, Bolus rate and Bolus Time, tap [Bolus Start] to enter the bolus interface, tap [ Bolus Stop] to stop the bolus Bolus rates are different depending on the syringe specification as follows.

  • Page 39: Replacing Syringe

    Operating Instructions 6.11 Replacing Syringe If the amount of solution in the syringe is getting low, repeat the steps in sections 6.3-6.6 to replace the syringe. 6.12 Powering Off the Pump  Press the [ON/OFF] button, and tap [Power Off], [Standby] or [Cancel]. ...

  • Page 40: Setting The Syringe Pump

    Setting the Syringe Pump 7 Setting the Syringe Pump CAUTION:  After the pump is powered off, all parameter settings will be automatically saved.  Parts of parameters will not be saved if the device is forcibly shutdown. 7.1 Infusion Setting Press the [HOME] button to enter the setting interface, tap [Infusion Set] to enter the detailed infusion setting interface.
  • Page 41 Setting the Syringe Pump  Weight mode In Weight mode, set the drug Info, Dose Rate, Weight, and VTBI, wait for the device to calculate the rate automatically, and then tap [Confirm] to operate.  Trapezia Mode In Trapezia mode, set the drug name, VTBI, rate, rise time, and fall time, wait for automatic calculation of the rate, and then tap [Confirm] to operate.
  • Page 42 Setting the Syringe Pump  Sequence Mode In Sequence Mode, set the drug name, 10 groups of sequence rate, and time and tap [Confirm] to operate in sequence. Note: A sequence for which only the time is set but rate is not set is supported, which functions as a paused sequence of the infusion process.

  • Page 43: Occlusion Level

    Setting the Syringe Pump 7.1.2 Occlusion Level  Eleven occlusion levels are available (Factory setting is level 6). Table 7-1 Relationship between occlusion level and pressure Occlusio Pressure Pressure Pressure Display Pressure (bar) n level (mmHg) (kPa) (psi) 4.35 5.80 7.25 8.70 10.15...

  • Page 44: Bolus Mode

    Setting the Syringe Pump 7.1.3 Bolus Mode  Three bolus modes are available: Manual Bolus, Rapid quantitative Bolus and Automatic Bolus. Please refer to chapter 6.9 for further instructions. 7.1.4 KVO  KVO-rate can be adjusted from 0.1ml/h to 5ml/h (adjustment step: 0.01ml/h).The default rate is 1ml/h.

  • Page 45: Micro Mode Setting

    Setting the Syringe Pump CAUTION:  The relay number must be set in sequence from number 1.  Relay Start Time is the time from completion of injection by a pump to start of injection by the next pump. Please set this parameter based on clinic requirement. 7.1.7 Micro Mode Setting ...

  • Page 46: Volume Set

    Setting the Syringe Pump 7.2.1 Volume Set  Ten volume levels are available (the factory setting is level 5). CAUTION:  Do not set the alarm volume to a level lower than the ambient noise to ensure that alarms can be recognized correctly in time. ...
  • Page 47 Setting the Syringe Pump  Tap [Info Channel] to choose the channel type.  Choose [Local WLAN] to use local WLAN channel to connect to the network, and the local WLAN parameters can be set.  Choose [Local RS485] to use local RS485-LAN cable to connect to the network.

  • Page 48: Lock Screen Set

    Setting the Syringe Pump 7.2.4 Lock screen Set  Tap [Screen Lock Password] to enable/disable the screen lock password function. When the function is enabled, a password is required to unlock the screen. When the function is disabled, no password is required to unlock the screen. ...

  • Page 49: Pressure Unit

    Setting the Syringe Pump 7.2.6 Pressure Unit  Choose the measurement unit for the pressure. The optional units are: mmHg, kPa, bar and psi. The default setting is mmHg. 7.2.7 Date&Time Set  Set the date, time, and their format. 7.2.8 Maintenance ...

  • Page 50: Alarm Set

    Setting the Syringe Pump 7.2.9 Alarm Set  The parameters on [Alarm Set] include [Reminder Alarm], [Near Finished], and [Tube Off].  [Reminder Alarm] provides two alarm levels: [Low] and [Middle]. The default level is [Low].  [Near Finished] provides two alarm levels: [Low] and [Middle]. The default level is [Low].

  • Page 51: Patient File

    Setting the Syringe Pump Event Record Parameters Flow rate change Occurrence time, Flow rate before and after change Alarm Occurrence time, alarm event, system trouble with trouble code Purge Occurrence time, purge rate, accumulated volume Purge stop Occurrence time, purge rate, purge accumulated volume CAUTION: ...

  • Page 52: Use Built-In Battery

    Setting the Syringe Pump 7.5 Use Built-in Battery  If no AC/DC power supply is available, the built-in battery powers the pump.  When external power stops working, the built-in battery starts and the yellow indicator illuminates(low level alarm) with a short alarm sound. ...

  • Page 53: Connecting To The Infusion Central Monitoring System

    Setting the Syringe Pump  The actual battery duration may be different and affected by the ambient temperature, flow rate, external communication, etc.  If the battery is aging, the actual battery duration may be shorter. Periodically check the battery. ...

  • Page 54: Troubleshooting

    Troubleshooting 8 Troubleshooting 8.1 Alarm The syringe pump provides users with a variety of status information about itself and its injection process. If any abnormality is detected, the syringe pump generates an alarm and notifies users in the form of sound, light, and character. All the alarms on this pump are of technical type.

  • Page 55: Faults And Troubleshooting

    Troubleshooting 8.2 Faults and Troubleshooting Table 8-2 Alarm symptom, alarm level, fault cause, and troubleshooting Alarm Alarm level Causes Troubleshooting Symptoms Power Low-level external AC/DC Immediately connect the Supply power supply AC power supply or the connected. external power supply. No Battery Low-level The syringe pump has...
  • Page 56 Troubleshooting Alarm Alarm level Causes Troubleshooting Symptoms SyringeNear Low-level It takes less than three Wait until syringe is Empty minutes to complete the completely empty infusion. Syringe Empty High-level The syringe is empty. Tap [Stop] to clear the alarm. Syringe High-level Syringe disengagement Tap [Stop] to clear the...

  • Page 57: Errors And Troubleshooting

    Troubleshooting 8.3 Errors and Troubleshooting When the device is faulty, a corresponding error code appears on the interface and at high-level alarm is generated. Table 8-3 Errors and troubleshooting Error code Alarm level Troubleshooting Sensor Error High-level Record the error code, power off the pump, and manufacturer manufacturer’s contact...

  • Page 58: Maintenance

    Maintenance 9 Maintenance 9.1 Cleaning and Disinfection  Before cleaning the pump, be sure to turn off the power and disconnect the AC or DC power cables, disconnect the device from the patient.  If any solution spills on the pump or the pump gets heavily soiled, wipe it with a wet soft cloth dampened with cold or lukewarm water.

  • Page 59: Checking The Power Cable

    Maintenance 9.2.2 Checking the Power Cable  Check the appearance of the power cable. If the appearance is damaged and the plug and the socket are in poor contact, contact manufacturer or manufacturer’s representatives for replacement in time.  If you connect the syringe pump to the AC/DC power and there is no indication of powering on, contact manufacturer or manufacturer’s representatives for maintenance in time.

  • Page 60: Replacing The Battery

    Maintenance  Perform the following inspections on the battery every half years, or after the pump is not used for a long time:  Connect the syringe pump to the AC power supply to fully charge the battery.  Turn on the power and install the syringe (50/60 ml syringe). ...

  • Page 61: Maintenance

    Maintenance CAUTION:  Replace the battery if the infusion pump is not likely to be used,especially the battery operation time becomes shorter. WARNING:  The battery’s replacement must be done by specialist who has been trained to perform such operations. The replacement of lithium batteries by inadequately trained personnel could result in an unacceptable risk hazard.

  • Page 62: Storage

    Maintenance who has been trained to complete such operations.  The pump should not be serviced or maintained while in use with the patient. 9.4 Storage  Avoid water spills.  Never store in a hot and humid place.  Store the pump away from excessive vibration, dustand corrosive gas. ...

  • Page 63: Flow Rate Characteristics

    Flow Rate Characteristics 10 Flow Rate Characteristics The following test is performed in accordance with the IEC60601-2-24:2012 standard. It is used to observe the infusion accuracy and the occlusion response. (For detailed test conditions, see the IEC60601-2-24:2012 standard.) CAUTION:  The infusion accuracy and the occlusion response may be affected by the use conditions including the pressure, temperature, humidity, IV set, and infusion tube.
  • Page 64 Flow Rate Characteristics Start-up curves of MC(50/60ml) 5ml/h Start-up curves of MC(50/60ml) 1ml/h Trumpet curve of MC(50/60ml) 5ml/h Trumpet curve of MC(50/60ml) 1ml/h Start-up curves of B.Braun(50/60ml) Start-up curves of B.Braun(50/60ml) 1ml/h 5ml/h Trumpet curve of B.Braun(50/60ml) 5ml/h Trumpet curve of B.Braun(50/60ml) 1ml/h 55/ 62...

  • Page 65: Occlusion Characteristics

    Flow Rate Characteristics 10.2 Occlusion Characteristics The occlusion characteristics are described with the longest response time of occlusion alarm and its related bolus volume. The following test method is accordance with the method mentioned in chapter 201.12.4.4.104 of the standard IEC 60601-2-24:2012. ...

  • Page 66: Appendix A Electromagnetic Compatibility (Emc)

    IEC 61000-3-3 Guidance and manufacturer’s declaration – electromagnetic immunity The [SYS-50/52] is intended for use in the electromagnetic environment specified below. The customer or the user of the [SYS-50/52] should assure that it is used in such an environment. IMMUNITY...
  • Page 67 Guidance and manufacturer’s declaration – electromagnetic immunity The [SYS-50/52] is intended for use in the electromagnetic environment specified below. The customer or the user of the [SYS-50/52] should assure that it is used in such an environment. Electromagnetic environment –...
  • Page 68 Appendix A IEC6100 80MHz; 80MHz; be used no closer to any part of the 0-4-6 6 Vrms in ISM 6 Vrms in ISM [SYS-50/52], including cables, than bands bands the recommended separation Between Between distance calculated from the 0.15MHz and 0.15MHz and 80...
  • Page 69 To assess the electromagnetic environment dueto fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the [SYS-50/52] is used exceeds the applicable RF compliance level above, the [SYS-50/52] should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the [SYS-50/52].

  • Page 70: Appendix B Default Factory Settings

    Appendix B Appendix B Default Factory Settings This chapter lists some default factory settings of syringe pump. Users can not modify the default factory settings, but if necessary, they can recover the syringe pump to the default factory settings state. Parameters Parameters setting The default factory setting...

  • Page 71: Appendix C Parameter Units

    Appendix C Appendix C Parameter Units Parameter Name Unit Acti Agent ng, ug, mg, g, U, KU, IU, EU, mmol, mol, kcal, mIU, kIU, and Conc. ng/ml, ug/ml, mg/ml, g/ml, U/ml, KU/ml, IU/ml, EU/ml, mmol/ml, mol/ml, kcal/ml, mIU/ml, kIU/ml, and mEq/ml x/min, x/kg/min, x/h, x/kg/h DoseRate (x is ng, ug, mg, g, U, KU, IU, EU, mmol, mol, kcal, mIU,...
  • Page 72 Street, Guangming, 518106 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany Fax: +86-755-26001651 Postal code: 518055 Website: http://www.medcaptain.com E-mail: MC.service@medcaptain.com © Copyright 2021 MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. All rights reserved.

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