MEDCAPTAIN MP-60 Operation Manual
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MEDCAPTAIN MP-60 Operation Manual

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Infusion Pump MP-60
Operation Manual
Please read this "Operation Manual" carefully and follow "Precautions for Use" before
using the MP-60 Infusion Pump .
MEDCAPTAIN MEDICAL TECHNOLOGYCO., LTD.

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Summary of Contents for MEDCAPTAIN MP-60

  • Page 1 Infusion Pump MP-60 Operation Manual Please read this “Operation Manual” carefully and follow “Precautions for Use” before using the MP-60 Infusion Pump . MEDCAPTAIN MEDICAL TECHNOLOGYCO., LTD.
  • Page 2 MEDCAPTAIN reserves the right for final interpretation of this Service Manual. MEDCAPTAIN reserves the right to modify the contents of this service manual for a more accurate and effective service quality. The modified contents should be reflected in the newly published service manual version.
  • Page 3 Intellectual Property and Statement  V2.2 Service interval modification and writing mistake correction   Publish date：2016.7.30...
  • Page 4 After 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 ....................1 NTENDED USE ..................1 ONTRAINDICATION ..................1 RODUCT EATURES PRECAUTIONS FOR USE ................3 PRODUCT SPECIFICATIONS..............8 PRODUCT DESCRIPTION ................. 10 ................10 RINCIPLE OF PERATION ..............10 OMPOSITION OF NFUSION .......................13 ANDLE ....................13 ROP SENSOR ....................13 LAMP ....................14...
  • Page 6 Contents ................21 ETTING THE INFUSION RATE ....................22 UNCTURE ..................22 TARTING NFUSION ..............23 HANGE RATE DURING INFUSION ......................23 OLUS 6.10 S ..................24 TOPPING NFUSION 6.11 R ..............24 EPLACING OR ADJUSTING 6.12 T ................25 URNING THE OWER SETTING THE INFUSION PUMP ............... 26 ....................26 NFUSION SET 7.1.1 Infusionmode ....................
  • Page 7 Contents ......................35 ISTORY ....................36 ATIENT ................36 NTERNAL BATTERY <I ONNECTING TO THE NFUSION ENTRAL ONITORING >( ) ....................38 YSTEM OPTIONAL ) ................38 URSE PAGER OPTIONAL ) ..............38 OICE COMMUNICATION OPTIONAL ) ..........38 ONNECTING A BARCODE SCANNER OPTIONAL 7.10 U ) ...........38 SPECIFIC EQUIREMENTS OPTIONAL...
  • Page 8 Contents ....................44 AINTENANCE .....................45 TORAGE ..................45 RANSPORTATION ..........45 NVIRONMENTAL ROTECTION AND ECOVERY INFUSION ACCURACY CHARACTERISTICS ..........46 10.1 F ..............46 HARACTERISTICS 10.2 O ..............49 CCLUSION HARACTERISTICS APPENDIX A ELECTRON MAGNETIC COMPATIBILITY (EMC) ......50 APPENDIX B THE DEFAULT FACTORY SETTINGS ..........56 APPENDIX CTOXIC AND HAZARDOUS SUBSTANCES OR ELEMENTS ....

  • Page 9: Overview

    1.2 Contraindication None 1.3 Product Features MEDCAPTAIN MP-60 is a micro-continuous infusion pump. It ensures constant infusion speed and accurate dosing volume during longtime infusion. This infusion pump is used for continuous and micro-volume infusion of liquid or liquid medicine of little volume and high concentration, including, but are not limited to the infusion of chemotherapeutic agents, cardiovascular drugs, antineoplastic, oxytocic, anticoagulant, anesthetic agents.
  • Page 10 Overview  Independent motor driving CPU and motor subdivided drive chip design.  Setting and giving automatic prompt of maintenance interval.  Modular installation design enables multi-channel pumps among pumps. Note: Handle, pole clamp, barcode scanner, WIFI communication module, voice communication, nurse call and relay infusion function are optional, dependingon the user’s need.

  • Page 11: 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 12 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 MP-60 and the patient simultaneously. CAUTION:  The infusion set is treated as the applied part of the pump.
  • Page 13 Precautions For Use  Before pressing the [START] key, check if the infusion speed is correct, especially the position of the decimal point.  Do not operate on the display with sharp objects. Otherwise, the display may be damaged.  Occlusion alarm may occur when high-viscosity liquid is infused at high speed through a thin intravenous needle.
  • Page 14 Precautions For Use occlusionwhen sensor failed.  The delay time between the onset of the alarm condition and the representation of the alarm is no longer than 150ms. 6 / 57...
  • Page 15 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 Specifies serial number TYPE CF APPLIED PART Alternating current Direct current DISPOSAL: Do not dispose this product as unsorted municipal waste.

  • Page 16: Product Specifications

    Product Specifications 3 Product Specifications Product name Infusion pump Model MP-60 AC power supply: AC 100-240V,50/60 Hz, power consumption 45 VA External DC power supply: DC 12 V 1A Internal battery: lithium battery 11.1 V 1500 mAh Power supply Battery model: 154457...
  • Page 17 Product Specifications alarm again in 2 minutes Event recording: Can store and playback 2000 events maximum Sound volume: 11 levels are available Power supply switching: When AC/DC power supply is cut off ,the infusion automatically switch to internal battery supply Barcode scanning: Input the patient information by barcode canning Connect infusion workstation, nurse pager, voice communication WIFI function...

  • Page 18: Product Description

    4 Product Description 4.1 Principle of Operation The MP-60 infusion pump mainly consists of pump shell, display screenand operating system, monitoring system, alarm system, motor drive system, tubing peristaltic module, power supply system, drop sensor, WIFI communication module (optional), handle (optional) and pole clamp (optional).
  • Page 19 Product Description 1 –Lighting lamp 2 – Depressor 3 – Anti-free-flow clamp 5 – Peristaltic pump plate 6 – Air bubble sensor 4–Anti-free-flow clamp button 7 –Pressure sensor 8 –Infusion tube slit 9 – Catch  Lighting lamp. To provide lighting in a dim environment, so as to install and check the infusion tube ...
  • Page 20 Product Description 1 –Battery cover 2 –Threaded hole 3 –Auxiliary alarm 4 – AC power inlet 5 –Combination clamp 6 –External inlet 1 7 –External inlet 2 8 –External inlet 3 9 –Buzzer 10 – Shell  attery chamber. Replaceable battery inside the chamber. ...

  • Page 21: Handle

    Product Description it is difficult to operate the disconnection device. 4.3 Handle 1 –Handle 2 –Slide rail 3 –Tubing management bracket 4.4 Drop sensor 1 –Button 2 –Drop hole 3 –Cable 4 –Socket 4.5 Pole Clamp 1 – Mounting screw 2 –...

  • Page 22: Nurse

    Product Description 4.6 Nurse Pager 1 –Button 2 –Cable 3 –Socket 4.7 Accessories accompanied 1 –AC power cord 2 – Pole clamp 3 – Handle 4 – Operation manual 1 5 –Packing list1 6 -– Quick-operation instruction 1 4.8 Optional Accessories Table 4-1 List of Optional Accessories Options...

  • Page 23: Preparations For Use

    Preparations For Use 5 Preparations for Use  Before using the infusion pump, read carefully the Operation Manual and precautions in this manual.  When using the infusion pump for the first time, set up the date and time to ensure that history can be recorded correctly.

  • Page 24: 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 alarms with three colors: red, yellow and green represent three levels of high, medium and low, depending on the importance of infusion information.
  • Page 25 Operating Instructions Occlusion pressure level: 2 Occlusion pressure real-time: a full set of 5 bars. The more bars displayed, the larger pressure it is. External power source. Displays when external AC/DC power source is connected. Screenlock symbol, consists of lock and unlock. Battery volume and charging states: a full set of 4 bars, the more bars displayed, the larger battery volume.

  • Page 26: Start Up

    Operating Instructions  Keys Except touchscreen keys, there are also 3 keys 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 preparing interface, press[HOME]once again in any setting interface.

  • Page 27: Set Installation

    Operating Instructions WARNING:  After the power switch is turned on, confirm the loudspeaker, warning indicator is working all right, and check if the self-test is finished and no error messages appear. (Refer to Chapter 8 Troubleshooting.)  Ensure the displayed IV set brand corresponds with the using IV set brand. ...
  • Page 28 Operating Instructions  Install the drop sensor CAUTION:  To ensure the accuracy of drop detection, the drop sensor should be installed as far as possible close to the down liquid level. The liquid level is approprite to be in the 1/3 of the drop champer.

  • Page 29: Purge

    Operating Instructions 6.4 Purge WARNING:  Before purging the IV line, ensure that the IV line is not connected to patients.  Priming can be done only in non-infusion process.  Ensure liquid has run out from the needle before stopping purging. ...

  • Page 30: Puncture

    Operating Instructions  Click [CLEAR] to clear the total volume.  Relationship between IV set specifications and range, see Table 6-2. The minimum increment see Table 6-3. Table 6-2 Relationship between IV set specifications and range IV set specification (d/mL) Setting range (mL/h) 0.1-1200.0 Table 6-3...

  • Page 31: Change Rate During Infusion

    Operating Instructions CAUTION:  Infusion can only start when the recipe value equals to the set value.  If no operation is performed after IV set installation for more than 2 minutes, START-REMINDER alarm sounds. 6.8 Change rate during infusion ...

  • Page 32: Stopping Infusion

    Operating Instructions Bolus rates are different depending on the IV set specification as follows. Table 6-4 between IV set specification and flow rate Relationship IV set specification Bolus rate（ml/h） The minimum bolus The maximum (d/ml) volume(ml) bolus volume(ml) 0.1-1200.0 50.0 CAUTION: ...

  • Page 33: Turning The Power Off

    Operating Instructions 6.12 Turning the Power Off  Press the [ON/OFF] key, choose Power Off, Standby or Cancel.  Click [Power Off] to shutdown.  Click [Standby] to enter standby interface, the standby time can be modify.  Click [Cancel] to return to previous interface. 25 / 57...

  • Page 34: Setting The Infusion Pump

    Setting the Infusion Pump 7 Setting the InfusionPump CAUTION:  After the pump is shutdown, all parameter settings will be automatically saved.  Parts of parameters will not be saved in force shutdown. 7.1 Infusion set Press [HOME] key to enter the setting interface, click [Infusion Set] to enter the detailed infusion setting interface.
  • Page 35 Setting the Infusion Pump  Weight mode Under the WeightMode, set the Conc, DoseRate, Weight and VTBI, the device will calculate the rate automatically. Click [Confirm] to operate.  Sequence Mode Under the Sequence Mode, set the 5 sequence rate and time, click [Confirm] to operate in sequence.

  • Page 36: Occlusion Level

    Setting the Infusion Pump CAUTION:  The pump will calculate the corresponding rate according to the current drip rate (dots/min) and current IV set’s spec.  The pump control the flow by using corresponding flow rate (ml/h) but not by detecting the drip rate (dots/ml).

  • Page 37: Bolus Mode

    Setting the Infusion Pump 7.1.3 Bolus Mode  There are three modes: Manual Bolus, Rapid quantitative Bolus and Automatic Bolus. Please refer to the chapter 6.9 for further instructions. 7.1.4 KVO Rate  KVO-rate could be adjusted from 0.1ml/h to 5ml/h (Step by 0.01ml/h), Default rate: 1ml/h.

  • Page 38: Nearfinished

    Setting the Infusion Pump  If disconnected the drop sensor but the drip mode is open, the pump produces no drop sensor alarm. 7.1.8 NearFinished  Near Finished Alarm: Alarm-time could be adjusted from 1min to 30min before Finished (Step by1min), Default time: 3min before Finished. 7.2 System Set 7.2.1 Volume Setting ...

  • Page 39: Internet Set

    Setting the Infusion Pump  There are seven different color options for UI type.  The brightness could be adjusted in [Normal Bright].  All the parameters of the night mode could be adjusted here. CAUTION:  Under the night mode, setting range of start time is 17:00-09:00, finish time range is the same as start time range.

  • Page 40: Lock Screen Set

    Setting the Infusion Pump CAUTION:  The pump could communicate with working station, and the working station could manage the alarm and implement relay function between pumps.  The setting of [Local RS485] and [Station RS485] must be done by the manufacturer’s representatives.

  • Page 41: 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 42: Pressureunit

    Setting the Infusion Pump 7.2.7 PressureUnit  Choose the measurement unit for the pressure. The optional units are: mmHg, kPa, bar and PSI. The default setting is mmHg. 7.2.8 Date&Time set  Set the date, time, and their format. 7.2.9 Maintenance ...

  • Page 43: History

    Setting the Infusion Pump 7.3 History The history records are as Table 7-2. Table 7-2 History records Event Record Parameters Start up Occurred time Shutdown Occurred time Standby Occurred time, standby set time Start Occurred time, rate, VTBI Bolus Occurred time, Bolus rate, Bolus way Bolus stop Occurred time, Bolus rate, Bolus accumulated volume Stop...

  • Page 44: Patient File

    Setting the Infusion Pump 7.4 Patient File  Click [Patient File] to enter the patient file page. The [Department], [Room No.], [Bed No.] and [Patient Data] could be set up.  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.
  • Page 45 Setting the Infusion Pump Table 7-3when battery works, the [Battery capacity] diagram state [Battery capacity]state The remaining capacity*1) Four bars light Operation will be possible for 300 minutes. Three bars light Operation will be possible for 210 minutes. Two bars light Operation will be possible for 140 minutes.

  • Page 46: Connecting To The

    Setting the Infusion Pump 7.6 Connecting to the <Infusion Central Monitoring System>(optional) Infusion pumps can be connected to the < Infusion Central Monitoring System >, which can obtain working states of pumps remotely. CAUTION：  Infusion pump cannot be operated through the < Infusion Central Monitoring System >.

  • Page 47: 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 sounds an alarm and notes users in the form of sound, light, and character. All the alarms on this pump are the technical type alarm.

  • Page 48: Faults And Troubleshooting

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

  • Page 49: Troubles And Trouble Shooting

    Troubleshooting Alarm Symptoms Alarm level Causes Troubleshooting Drop Error Low-level The drip rate is detected to Press [Cancel] to remove be incorrect at the drip alarm. check kettle during the infusion. installation drop sensor. No drop sensor Mid-level The drop sensor detection Install the drop sensor, or function is turned on, but turn...

  • Page 50: Maintenance

    Maintenance 9 Maintenance 9.1 Cleaning, Disinfecting  Before cleaning the pump，be sure to turn off the power and disconnect the AC or DC power cables.  If there is dirt on the pump，wipe it with wet soft cloth dampened with cold or lukewarm water.

  • Page 51: Checking The Infusion Rate

    Maintenance representatives for replacement in time.  If you connect the infusion pump to the AC/DC power and there is no indication of powering on, contact manufacturer or manufacturer’s representative for maintenance in time. 9.2.3 Checking the infusion rate  Check the infusion flow once every 2 years by the graduate and timer.

  • Page 52: Replacing The Battery

    Maintenance  If the time from the start of the infusing to end of operation is 1 to 1.5 hours, the battery condition is reaching its service life.  If the time from the start of the infusing to end of operation is less than 1 hour, the battery has reached its service life.

  • Page 53: Storage

    Maintenance  Never disassemble or try to repair the infusion pump or it may cause a serious failure. The manufacturer and the distributor shall not be responsible for any infusion pump that has been disassembled，modified or used for any purpose other than that for which it is intended.

  • Page 54: 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 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 55 -6.61 supplycontainer below pump mechanismat a distance of 0.5m +2.57 Minimum rate 1ml/h, normal condition +2.28 Intermediate rate 25ml/h,normal condition Intermediate rate 25ml/h,with -1.10 +13.3kpabackpressure Medcaptain(MC) Intermediate rate 25ml/h, with 20d/mL +1.00 -13.3kpabackpressure Intermediate rate 25ml/h,when -11.62 supplycontainer below pump mechanismat a distance of 0.5m...
  • Page 56 Infusion Accuracy Characteristics Table 10-2 Accuracy test result Start-up curves ofMC 1mL/h Start-up curves of MC 25mL/h Trumpet curve of MC 25mL/h Trumpet curve of MC 1mL/h Start-up curves of B.Braun 25mL/h Start-up curves ofB.Braun 1mL/h Trumpet curve of B.Braun 25mL/h Trumpet curve of B.Braun 1mL/h 48 / 57...

  • Page 57: 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 58: Appendix A Electron Magnetic Compatibility (Emc)

    The MP-60 Infusion Pump conforms to EMC standard EN 60601-1-2. Guidance and manufacturer’s declaration – electromagnetic emissions The [MP-60] is intended for use in the electromagnetic environment specified below. The customer or the user of the [MP-60] should assure that it is used in such an environment. Emission test...
  • Page 59 Guidance and manufacturer’s declaration – electromagnetic immunity The [MP-60] is intended for use in the electromagnetic environment specified below. The customer or the user of the [MP-60] should assure that it is used in such an environment. IMMUNITYtest IEC60601test level...
  • Page 60 Appendix A frequency fields should be at levels magnetic fields characteristic of a typical （50/60Hz） location typical IEC 61000-4-8 commercial hospital environment NOTE U is the a.c mains voltage prior to application of the test level. 52 / 57...
  • Page 61 Guidance and manufacturer’s declaration – electromagnetic immunity The [MP-60] is intended for use in the electromagnetic environment specified below. The customer or the user of the [MP-60] should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic environment –guidance...
  • Page 62 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the [MP-60] is used exceeds the applicable RF compliance level above, the [MP-60] should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the [MP-60].
  • Page 63 Recommended separation distances between portable and mobile RF communications equipment and the [MP-60] The [MP-60] is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the [MP-60] can help prevent...

  • Page 64: Appendix B The Default Factory Settings

    Appendix B Appendix B The 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 65: Appendix Ctoxic And Hazardous Substances Or Elements

    Appendix C Appendix CToxic and Hazardous Substances or Elements Polybromi polybrominat Plumbum Mercury Cadmium Chromium nated ed diphenyl Description VI Cr(VI) biphenyls ethers PBDE ○ ○ ○ ○ ○ ○ pump shell key and ○ ○ ○ ○ ○ ○ cover ○...
  • Page 66 West Road, Xili, Nanshan District, Shenzhen, P.R.China EU- Representative name: WellKang Ltd EU- Representative address: Suite B, 29 Harley Street LONDONW1G 9QR, England, United Kingdom Telephone: +86-755-26953369 0123 Fax: +86-755-26001651 Postal code: 518055 Website: http://www.medcaptain.com E-mail: info@medcaptain.com Copyright of 2016 Medcaptain Medical Technology Co., Ltd. (V2.2)

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