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MEDCAPTAIN SYS-6010 Series Operation Manual

Infusion pump
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SYS-6010 Series Infusion Pump
Operation Manual
Please read this "Operation Manual" carefully and follow "Precautions for Use" before us
Please read this "Operation Manual" carefully and follow "Precautions for Use" before using the SYS-
6010 Series Infusion Pump.
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

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  • Page 1 SYS-6010 Series Infusion Pump Operation Manual Please read this “Operation Manual” carefully and follow “Precautions for Use” before us Please read this “Operation Manual” carefully and follow “Precautions for Use” before using the SYS- 6010 Series Infusion Pump. MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
  • Page 2 Intellectual Property and Statement The intellectual property right of this product and its Operation Manual belong to MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. (hereinafter referred to as MEDCAPTAIN). ©2016-2021 MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. All Rights Reserved. Without prior approval from MEDCAPTAIN in written, this Operation Manual shall not be photocopied, modified or translated, fully or partially, by any individual or organization.
  • Page 3 Intellectual Property and Statement  V1.5  Added warning  Issued on: 2019-3  V1.6  Optimize picture quality.  Issued on: 2019-4  V1.7  Added warning.  Issued on: 2019-07  V1.8  Changed the model and parameters of the built-in lithium battery. Added the continuous use time of the battery if the rate is 125ml/h.
  • Page 4 After-Sale Service Thank you for using the Infusion Pump of MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.  During the warranty period, we provide free after-sale services except the following causes:  Artificially damaged.  Inappropriate use.  The voltage of supply network exceeds the range.

  • Page 5: Table Of Contents

    Contents Overview ........................1 Intended Use ......................1 Contraindication ......................1 Product Features......................1 Precautions for Use ......................2 Product Specifications ....................7 Product Description .....................10 Operating Principle ....................10 Composition of Infusion Pump ................10 Drop Sensor ......................13 Pole Clamp .......................13 Nurse Call ........................14 Accessories Accompanied ..................14 Optional Accessories ....................14 Preparations for Use .....................15 Operating Instructions ....................16...
  • Page 6 Contents 7.2.2 Display SET ....................31 7.2.3 Internet Set ....................31 7.2.4 Lock Screen Set ...................32 7.2.5 Collection Set ....................33 7.2.6 Linkage Mode ....................33 7.2.7 Pressure Unit ....................33 7.2.8 Date & Time Set ..................34 7.2.9 Maintenance ....................34 History........................34 Patient File .......................35 Use Internal Battery ....................36 Connecting to the <Infusion Central Monitoring System>...

  • Page 7: Overview

    None. 1.3 Product Features MEDCAPTAIN SYS-6010 Series is a micro-volume continuous-operation infusion pump. It ensures constant infusion rate and accurate dosing volume during long time infusion. This infusion pump is used for continuous and micro-volume infusion of liquid or liquid...

  • Page 8: Precautions For Use

    Precautions for Use 2 Precautions for Use In this manual, precautions are classified into warning and caution according to the importance. The meanings are as follows: WARNING: The information is about safety and efficiency. Operation against the warning may cause injuries.
  • Page 9 There is no patient circuit in this device. The output of the equipment is not allowed to be accessible to patient.  The operator shall not touch SYS-6010 Series and the patient simultaneously.  This infusion pump supports blood transfusion. When this pump is used for blood transfusion, only a disposable consumable dedicated for blood transfusion can be used in combination with it.
  • Page 10 Precautions for Use fall, violent mechanical vibration or other external force.  Before pressing the [START] key, check if the infusion rate is correct, especially the position of the decimal point.  An occlusion alarm may be generated when high-viscosity liquid is infused at high rate through a thin intravenous needle.
  • Page 11 Precautions for Use Symbols: Authorized Representative in the European Community CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC. Date of manufacture. Manufacturer Serial number Medical device. Defibrillation-proof type CF applied part Alternating current Direct current DISPOSAL: Do not dispose this product as unsorted municipal waste. Separate collection of such waste for special treatment is necessary.
  • Page 12 Precautions for Use OPEN Protective earth. 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, 9…, for the specific value, see the product package box.) USB2.0 interface Direction of infusion When installing an infusion set, do not bend or twist the infusion set.

  • Page 13: Product Specifications

    Product Specifications 3 Product Specifications Product name Infusion pump Model SYS-6010 Series AC power supply: AC 100-240V,50/60 Hz, power consumption 45 VA External DC power supply: DC 12 V 1A Power supply Internal battery: lithium battery 7.2V 2600 mAh Battery model: 18650-2S1P-02...
  • Page 14 Product Specifications Bolus VTBI 0.10-50.00ml Anti-bolus function, unintended bolus ≤ 1.0 ml Anti-Bolus KVO rate 0.1-5.0ml/h Air bubble alarm accuracy is ±15μl or ± 20% (whichever is greater). Single Bubble Bubble Level: 25, 50, 100, 200, 300, 500, and 800 (μl) Bubble Level: 100μl/15min, 200μl/15min, 400μl/15min, 500μl Total Bubbles /15min, 600μl/15min, 800μl/15min, and 1000μl/15min...
  • Page 15 Product Specifications ≤ 3000m Operating Altitude Temperature: -20° C to +55° C Storage shipping , non-condensing Humidity: 10% to 95% RH conditions Pressure altitude: 22.0kPa-107.4kPa 1. Class I / Internally powered equipment; 2. Defibrillation-proof type CF applied part; 3. IPX2; Classification 4.

  • Page 16: Product Description

    4 Product Description Operating Principle The SYS-6010 Series infusion pump mainly consists of pump shell, display screen and operating system, monitoring system, alarm system, motor drive system, tubing peristaltic module, power supply system, drop sensor, WI-FI communication module (optional), handle (optional) and pole clamp (optional).
  • Page 17 Product Description 1 –Infusion tube slit 2 –Peristaltic pump tablets 3 – Lighting lamp 5 –Catch 6 – Air bubble sensor 4–Depressor 7 –Pressure sensor 8 –Anti-free-flow clamp 9–Anti-free-flow clamp button  Infusion tube slit. At sides of pump to guide the infusion tube in a line behind the pump door. ...
  • Page 18 Product Description 1 –Battery cover 2 –Threaded hole 3 –Buzzer 4 –Auxiliary alarm 5 –External inlet 1 6 –AC power inlet 7 –External inlet 2 8 –External inlet 3 9 –Shell  Battery chamber. Replaceable battery inside the chamber.  Threaded hole.

  • Page 19: Drop Sensor

    Product Description  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. IEC 60950 and IEC 62368-1 for data processing equipment). All configurations shall comply with the requirements for medical electrical systems (see clause 16 of the 3Ed.

  • Page 20: Nurse Call

    Product Description  During installation, ensure that the knob and mounting screw are tightened up. Nurse Call 1 –Button 2 –Cable 3 –Socket Accessories Accompanied 1 –AC power cord 2 - Pole clamp 3 –Operation manual 4 - Packing list 5 –Quick-operation instruction 1 Optional Accessories Table 4-1 List of Optional Accessories...

  • Page 21: Preparations For Use

     For the first time to use the infusion pump or after changing the infusion brand set, please contact the engineer authorized by Medcaptain to conduct an infusion accuracy calibration. CAUTION:  Do not install the infusion pump at a place not convenient for an operator to connect the AC power.

  • Page 22: Operating Instructions

    Operating Instructions 6 Operating Instructions 6.1 Display and Keys  Display 1 –Alarm indicator 2 –TFT Touchscreen 3 –Home key 4 –ON/OFF key 5-OPEN key The alarm indicator indicates the alarm severity (high, medium, or low) with three colors: red, yellow and green.
  • Page 23 Operating Instructions Information area: Displays the infusion set brand and specification, occlusion level, real- time pressure, external power source, battery capacity and WI-FI signal. Touch the brand and specifications zone to enter the page for infusion set brand adjustment. Touch the occlusion pressure level to enter the page for occlusion level selection.

  • Page 24: Starting The Pump

    Operating Instructions  Keys In addition to touchscreen keys, three keys are available on the key panel: [HOME], [ON/OFF] and [OPEN].  [HOME]: Main menu key. Before infusion, press [HOME] once to enter a setting menu, such as Infusion set, Local set, History and Interconnect set. To return to the infusion preparation screen, press [HOME] once again on any setting interface.

  • Page 25: Infusion Set Installation

    Operating Instructions WARNING:  After the pump is powered on, confirm that the loudspeaker and alarm indicator work properly. In addition, check if the self-test is finished and no error messages appear. (Refer to Chapter 8 Troubleshooting.)  Ensure that the infusion set brand displayed is consistent with the brand of the infusion set actually used.
  • Page 26 Operating Instructions  Install the drop sensor CAUTION:  To ensure the accuracy of drop detection, the drop sensor should be installed as close as possible to the down liquid level. The liquid level is appropriate to be at the 1/3 of the drop chamber.

  • Page 27: Purge

    Operating Instructions 6.4 Purge WARNING:  Before purging the IV line, ensure that the IV line is not connected to patients.  Purging can be done only in non-infusion process.  Stop purging after ensuring that liquid is drained out from the needle. ...

  • Page 28: Puncture

    Operating Instructions CAUTION:  After you change the infusion rate and confirm the change during infusion, subsequent infusion is performed at the rate after the change. 6.6 Puncture Insert the vein infusion needle into the patient’s vein. 6.7 Starting Infusion Click [START] to start infusion at the setting rate.

  • Page 29: Bolus

    Operating Instructions 6.9 Bolus SYS-6010T and SYS-6010A: Support three bolus modes, that is, manual bolus, rapid quantitative bolus, and automatic bolus. SYS-6010: Only supports automatic bolus.  Choose “Manual bolus”, during the infusion, press and hold [Bolus] for 1s to enter the bolus interface.

  • Page 30: Stopping Infusion

    Operating Instructions Bolus rates are different depending on the infusion set specification as follows. CAUTION:  Current bolus volume is displayed when bolus is running.  Bolus volume will be accumulated into the total volume. 6.10 Stopping Infusion In the infusion process or after infusion, press the [STOP] key to stop the operation and green indicator will be off.

  • Page 31: Setting The Infusion Pump

    Setting the Infusion Pump 7 Setting the Infusion Pump CAUTION:  After the pump is shutdown, all parameter settings will be automatically saved.  Parts of parameters will not be saved in force shutdown. Infusion Set Press the [HOME] key to enter the setting interface, click [Infusion Set] to enter the detailed infusion setting interface.
  • Page 32 Setting the Infusion Pump  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 click [Confirm] to operate.  Loading Dose mode In Loading Dose mode, set the drug name, VTBI, maintain rate, loading rate and loading time, wait for automatic calculation of the rate, and then click [Confirm] to operate.
  • Page 33 Setting the Infusion Pump  Drip mode In Drip mode, set the drug info, loading dose, loading time dose rate and weight, wait for automatic calculation of the rate, and then click [Confirm] to operate. CAUTION:  The pump will calculate the corresponding rate according to the current drip rate (dots/min) and current infusion set’s specification.

  • Page 34: Occlusion Level

    Setting the Infusion Pump 7.1.2 Occlusion Level Three occlusion levels are available (Factory setting is level 2). Table 7-1 Relationship between occlusion level and pressure Occlusion Pressure(mm Pressure Pressure Pressure Display level (kPa) (bar) (psi) 10.6 17.4 CAUTION:  When an occlusion alarm is reported, the motor automatically rotates reversely to release the tube pressure (Anti-Bolus) for preventing infusion of extra amount of pills into a patient after the occlusion alarm is cleared.

  • Page 35: Drip Mode Set

    Setting the Infusion Pump accordingly for clinical use. CAUTION:  Users must use the consumable brand which is specified by the manufacturer.  To add infusion set of other brand, users are strongly recommended to contact the supplier of the infusion pump to set and test, so as to ensure the infusion accuracy. ...

  • Page 36: Near Finished

    Setting the Infusion Pump CAUTION:  Choose L gear level to detect bubbles may cause discomfort or danger to the patient, according to the actual clinical choose the right gear, and closely observe if there is any abnormal immediate measures should be taken 7.1.9 Near Finished ...

  • Page 37: Display Set

    Setting the Infusion Pump 7.2.2 Display SET  Seven different color options are available for UI type.  The brightness can be adjusted in [Normal Bright].  All the parameters of the night mode can be adjusted here. CAUTION:  In night mode, the setting range of start time is 17:00-09:00, and the setting range of finish time is the same as that of start time.

  • Page 38: Lock Screen Set

    Setting the Infusion Pump CAUTION:  The setting of local port should be operated by professionals specified by the manufacturer. Contact the distributor or manufacturer.  Only the accessory and devices supplied or specified by the manufacturer are allowed to be connected to the pump.

  • Page 39: Collection Set

    Setting the Infusion Pump 7.2.5 Collection Set  [Mode Collection]: Choose the frequently used infusion mode from the [Infusion mode] option. Once the frequently used infusion modes are chosen, the unnecessary modes will not appear in the list of 7.1.1 [Infusion mode] option. The default setting is “all the four infusion modes are chosen”.

  • Page 40: Date & Time Set

    Setting the Infusion Pump 7.2.8 Date & Time Set  Set the date, time, and their format. 7.2.9 Maintenance  Click [Maintenance] option to do the [Language Select], [Touch Adjust], [Factory Data Reset], and check the version information.  To check the version information, follow the route of: [Home] -> [System Set] -> [Maintenance] ->...

  • Page 41: Patient File

    Setting the Infusion Pump Shutdown Occurrence time Standby Occurrence time, standby set time Start Occurrence time, rate, VTBI Bolus Occurrence time, Bolus rate, Bolus way Bolus stop Occurrence time, Bolus rate, Bolus accumulated volume Stop Occurrence time, rate, accumulated volume Occurrence time, accumulated volume, KVO rate KVO stop Occurrence time, KVO rate, KVO accumulated volume...

  • Page 42: Use Internal Battery

    Setting the Infusion Pump  Click [Patient Data] option to enter patient data setting page. Choose [New] to build a new patient data and the previous patient data will be cleared automatically. Choose [Modify] to modify the current patient data. CAUTION: ...

  • Page 43: Connecting To The (Optional)

    Setting the Infusion Pump  A fully charged new battery can be continuously used for not less than 2h at the rate of 1200 ml/h.  A fully charged new battery can be continuously used for not less than 5h at the rate of 125 ml/h.

  • Page 44: Troubleshooting

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

  • Page 45: Faults And Troubleshooting

    Troubleshooting 8.2 Faults and Troubleshooting Table 8-2 Alarm symptom, alarm level, fault cause, and troubleshooting Alarm Alarm Causes Troubleshooting Symptoms level No external AC/DC power supply is Immediately connect the Power Low-level connected. AC power supply or the Supply external power supply.

  • Page 46: Troubles And Troubleshooting

    Troubleshooting Alarm Alarm Causes Troubleshooting Symptoms level Forget to operate the alarm (no key Press any key to clear the Reminder Low-level operation is made two minutes after alarm. Alarm the infusion set is installed). During infusion, the drips are Press [Stop] to remove the Drop Error High-level...

  • Page 47: Maintenance

    Maintenance 9 Maintenance 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 there is dirt on the pump, wipe it with wet soft cloth dampened with cold or lukewarm water.

  • Page 48: Checking The Infusion Rate

    Maintenance 9.2.3 Checking the Infusion Rate  Check the infusion flow once every 2 years by using the graduate and stopwatch. Checking condition: Infusion set Infusion rate Infusion time Volume in graduate MC/B.Braun20d/ml 120ml/h 6min 11. 4-12.6ml 9.2.4 Alarm  Occlusion alarm Checking condition: Infusion set...

  • Page 49: Replacing The Battery

    Maintenance 9.2.7 Replacing the Battery  Remove the internal battery.  Turn the power off and disconnect the power cord.  Use a screwdriver to loosen the battery cover fixing screws at the bottom of the pump.  Remove the battery cover. ...

  • Page 50: Storage

    Maintenance CAUTION:  Serviceman can request for the related service manual from the manufacturer if needed. WARNING:  The accessories replacement should be operated by professionals, or it will cause damage.  Parts of the Pump are not serviced or maintained while in use with the patient. Storage ...

  • Page 51: Infusion Accuracy Characteristics

    Infusion Accuracy Characteristics 10 Infusion Accuracy 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 IEC 60601-2-24:2012 standard.) CAUTION: ...
  • Page 52 Minimum rate 1ml/h, normal condition 1.26 Intermediate rate 25ml/h, normal condition Intermediate rate 25ml/h, with +13.3kpa -0.18 backpressure MEDCAPTAIN 20d/ml Intermediate rate 25ml/h, with -13.3kpa -0.57 backpressure Intermediate rate 25ml/h, when the supply -10.07 container below the pump mechanism at a distance of 0.5m...
  • Page 53 Infusion Accuracy Characteristics Table 10-2 Accuracy test result Start-up curves of MC 25ml/h Start-up curves of MC 1ml/h Trumpet curve of MC 25ml/h Trumpet curve of MC 1ml/h Start-up curves of B.Braun 25ml/h Start-up curves of B.Braun 1ml/h Trumpet curve ofB.Braun 25ml/h Trumpet curve ofB.Braun 1ml/h 47 / 55...

  • Page 54: Occlusion Characteristics

    Infusion Accuracy Characteristics 10.2 Occlusion Characteristics The occlusion characteristics are reflected by the longest delay time to start an alarm. 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 (Please check above chapter for further details.).

  • Page 55: Appendix A Electromagnetic Compatibility (Emc)

    The SYS-6010 Series Infusion Pump conforms to EMC standard IEC 60601-1-2. Guidance and manufacturer’s declaration – electromagnetic emissions The SYS-6010 series Infusion Pump should be used under the regulation electromagnet environment. The user should operate the SYS-6010 series Infusion Pump under following electromagnet environment.
  • Page 56 Guidance and manufacturer’s declaration – electromagnetic immunity The [SYS-6010 series] is intended for use in the electromagnetic environment specified below. The customer or the user of the [SYS-6010 series] should assure that it is used in such an environment. IMMUNITY test...
  • Page 57 )25 period during power mains 70% U (dropping interruptions, <5% U (dropping>95% 30% U )25 period recommended that the )5seconds [SYS-6010 series] be <5% powered from (dropping>95% uninterruptible power )5seconds supply or a battery. Power 3 A/m 3 A/m Power...
  • Page 58 Guidance and manufacturer’s declaration – electromagnetic immunity The [SYS-6010 series] is intended for use in the electromagnetic environment specified below. The customer or the user of the [SYS-6010 series] should assure that it is used in such an environment. IEC 60601 Compliance Electromagnetic environment –guidance...
  • Page 59 If the measured field strength in the location in which the [SYS-6010 series] is used exceeds the applicable RF compliance level above, the [SYS-6010 series] 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-6010 series].

  • Page 60: Appendix B Default Factory Settings

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

  • Page 61: 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, mEq 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, mEq/ml DoseRate x/min, x/kg/min, x/h, x/kg/h.
  • Page 62 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 2016-2021 MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. All rights reserved.

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