MEDCAPTAIN SYS-6010 Operation Manual

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

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Summary of Contents for MEDCAPTAIN SYS-6010

  • Page 1 Infusion Pump SYS-6010 Operation Manual Please read this “Operation Manual” carefully and follow “Precautions for Use” and “Preparations for Use” before using the SYS-6010 Infusion Pump. MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
  • Page 2 Intellectual Property and Statement The intellectual property right of this product and its Service Manual belongs to MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. (hereinafter short as MEDCAPTAIN). ©2014-2015 All rights reserved MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. Without prior approval from MEDCAPTAIN in writing, this Service Manual shall not be photocopied, modified or translated, fully or partially, by any individual or organization.
  • Page 3 After-sale Service Thank you for using the infusion pump of MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.  The warranty period is calculated from installation date filled in Product Warranty Card. The card is the only proof to calculate the warranty period attached with the device in packing carton.
  • Page 4 Fax: 0755-26001651 Postal: 518055 Website: http://www.medcaptain.com E-mail:info@medcaptain.com Warning :The device should be operated by clinic medical staffs or under the instruction of special clinic medical staffs. The operator should have been trained on how to use this product.
  • Page 5: Table Of Contents

    Contents OVERVIEW ..................... 1 1.1....................... 1 URPOSE 1.2..................1 RODUCT EATURES PRECAUTIONS FOR USE ................2 PRODUCT SPECIFICATIONS ................ 5 PRODUCT DESCRIPTION ................7 4.1................7 RINCIPLE OF PERATION 4.2..............7 OMPOSITION OF NFUSION 4.3....................10 ROP SENSOR 4.4.
  • Page 6 7.5................ 24 SING THE UILT ATTERY 7.6. ) ..........26 ONNECTING A BARCODE SCANNER OPTIONAL 7.7. ) ........... 26 SPECIFIC EQUIREMENTS OPTIONAL TROUBLESHOOTING .................. 27 8.1......................27 LARM 8.2..............27 AULTS AND ROUBLESHOOTING TROUBLES AND TROUBLESHOOTING……………………………………………….30 8.3. MAINTENANCE ....................
  • Page 7: Overview

    1.2. Product Features MEDCAPTAIN SYS-6010 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, for example, infusion of chemotherapeutic agents, cardiovascular drugs, antineoplastic, oxytocic, anticoagulant, anesthetic agents, etc.
  • Page 8: Precautions For Use

    Precautions for Use 2. Precautions for Use In this manual, precautions are classified into warning and caution according to their importance. The meanings are as follows: WARNING: The information is about safety and efficiency. Operation against the precautions may cause injuries. CAUTION: The information is about guiding suggestions.
  • Page 9  There should be a regular monitoring by clinical professionals when using the device.  High-frequency surgical equipment, mobile phone, wireless device and defibrillator may have interference on the infusion pump. Keep away from them while operating. CAUTION:  Check the setting values on the prescription and the infusion pump. Infusion can start only when the values are equal.
  • Page 10 short-circuiting. While connecting the power cable, check if the connecting parts are dry. If liquid spills on the infusion pump, clean the pump with a dry cloth. Use after the service engineer checking. Symbols Table 2-1 List of symbols Symbol Description Symbol Description...
  • Page 11: Product Specifications

    Product Specifications 3. Product Specifications Product name Infusion pump Model SYS-6010 Power supply AC power supply: AC 100-240V,50/60 Hz, power consumption less than 25 VA External DC power supply: DC 12 V Internal battery: lithium battery 11.1 V 1500 mAh...
  • Page 12 Alarm Near End, Drug Empty, Infusion End, Occlusion Alarm, Low Battery, Battery Empty, No Battery, No Power Supply, Door open, Air Bubble, No Drop Sensor, No Drop Signal, Drop Error, Reminder Alarm, and alarms during self-test and running. Special function Repeat alarming: If there is still alarm after mute alarm sound, it will alarm again in 2 minutes Event recording: can store and playback 1000 events maximum...
  • Page 13: Product Description

    4. Product Description 4.1. Principle of Operation The SYS-6010 infusion pump consists of the pump shell, control system, input system, display system, storage system, sensor monitoring system, alarm system, motor drive system, tubing peristaltic module, power supply system, and pole clamp. The infusion pump adopts the dual...
  • Page 14 1 –Infusion tube slit 2 –Peristaltic pump plate 3 –Lighting lamp 4 –Depressor 5 –Catch 6 –Air bubble sensor 7 –Pressure sensor 8 –Anti-free-flow clamp 9– Anti-free-flow clamp button 1) Anti-free-flow clamp button. Press the button and the clamp will automatically open or close. 2)...
  • Page 15 1 –Battery cover 2 –Threaded hole 3 –Buzzer 5 –External inlet 1 6 –AC power inlet 4 -Auxiliary alarm 7 –External inlet 2 9 – Shell 8 - External inlet 3 8) Battery chamber. Replaceable battery inside the chamber. 9) Threaded hole. To fix the pole clamp then fix the pump to the IV pole via the pole clamp.
  • Page 16: Drop Sensor

    4.3. Drop sensor 1 –Button 2 –Drop hole 3 –Cable 4 –Socket 4.4. Pole Clamp 1 - Mounting screw 2 - Mounting knob of infusion stand 4.5. Accessories accompanied 1 –AC power cord 2 - Pole clamp 3 - Operation manual 1 4 - Certificate 5 - Packing list...
  • Page 17: Options

    4.6. Options Figure 4-1 options list Options Description Parts code Power cable Standard configuration by 7000000000 factory Lithium battery pack 11.1V@1500mAh 7404000006 Drop sensor MP-3 9114002521 Barcode scanner MP-4 9005000008 —— Pole clamp 9114002501...
  • Page 18: Preparations For Use

    Preparations for Use 5. Preparations for Use 1) Before using the infusion pump, read carefully the Operation Manual and precautions in this manual. 2) When using the infusion pump for the first time, set up the date and time to ensure that history can be recorded correctly.
  • Page 19: Operating Instructions

    Operating Instructions 6. Operating Instructions 6.1. Display and keys 1) Display 1 –Alarm Indicator 2 –TFT Touchscreen 3 –Home key 4 –ON/OFF key 5-OPEN key The alarm indicator indicates alarms in three colors: red, yellow and green in three levels of high, medium and low.
  • Page 20 Information area: to display the patient name, MEDCAPTAIN record No., bed No., IV set brand and specifications, occlusion pressure level, pressure real-time, RATE mL/h external power supply, battery volume, WIFI signal. See below for further description. TOTAL Occlusion pressure level: 2...
  • Page 21: Turning The Power On

    【ON/OFF】 : Switch on/off key. When the pump is off, press and hold 【ON/OFF】 for 1 second to switch it on. When the pump is on, press 【ON/OFF】, and a prompt pops up: Are you sure to shut down? Press the key on the display to shut down or press and hold for 3 seconds to force shutdown.
  • Page 22: Set Installation

    WARNING  Ensure the displayed IV set brand corresponds with the using IV set brand.  If the IV set brand set is different from the using IV set brand, the infusion accuracy and alarm function cannot be guaranteed.  Previous patient information will be cleared if [Yes] is selected on the New Patient screen.
  • Page 23: Purging

    7)Install the drop sensor 6.4. Purging 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 24: Setting The Infusion Rate

    Press and hold the [PURGE] key to infuse quickly. Release the [PURGE] key to stop the operation. Relationship between IV set specifications and purge rate, refer to the Table 6-1. Table 6-1 Relationship between IV set specifications and purge rate IV set specification Purge rate(mL/h)...
  • Page 25: Puncture

    6.6. Puncture Insert the vein infusion needle into the patient’s vein. 6.7. Starting Infusion Press the [START] key to start infusion at the setting rate. MEDCAPTAIN CAUTION:  Infusion can only start when the recipe value equals to the set value.
  • Page 26: Stopping Infusion

    Bolus Total(mL) MEDCAPTAIN 1200. × BOLUS mL/h ← → BOLUS TOTAL SHIFT STOP STOP BOL Relationship between IV set specification and flow rate IV set Bolus rate(ml/h) The minimum The maximum specification bolus volume(ml) bolus volume(ml) (d/ml) 0.1-1200.0 100.0 0.1~400.0 100.0...
  • Page 27: Setting The Infusion Pump

    After the pump is powered off, all parameter settings will be automatically saved.  Parts of parameters will not be saved if force shutdown. 7.1. Infusion setting Press [HOME] key to enter the setting interface, and touch items to enter corresponding interface. MEDCAPTAIN INFUSION OPTION HISTORY PATIENT 7.1.1. [IV set] setting...
  • Page 28 MEDCAPTAIN 2) Drop mode Under the rate mode, set the drop rate, connect the drop sensor, and touch [START] to run. You can set the limit volume to be on or off. MEDCAPTAIN 3) Time mode Under the time mode, the infusion rate will be calculated automatically by setting [Limit] and [Time].
  • Page 29 MEDCAPTAIN 7.1.3. [Occ. Level] setting Occlusion level can be set to 1, 2, or 3 (increases in turn). (The factory default setting is 2.) Table 7-1 Relations between occlusion level and pressure Occlusion level Display Occlusion pressure range 300± 100mmHg(40.0± 13.3kPa)...
  • Page 30: Ption

    7.2. Option OPTION Date/Time Sound Volume Display Touch Screen Security Setup Recover Default Network Setup Maintenance Clamp Mode 7.3. History S/N: 996 2013-03-07 17:13 RATE: 200.0mL/h LIMIT:2.0mL TOTAL: 0.0mL Infusion Start S/N: 996 2013-03-07 17:13 RATE: 200.0mL/h LIMIT:2.0mL TOTAL: 0.0mL No Battery S/N: 996 2013-03-07 17:13 RATE: 200.0mL/h LIMIT:2.0mL...
  • Page 31 4) The approx. remaining power in the built-in battery is displayed by [battery] indicators. During battery operation,battery discharged is shown by a decreasing number of active indicators. For details, see Table 7-2. Table 7-2 Status of the Battery indicator when the battery is discharged Guideline of residual battery Battery Indicator status power*1)
  • Page 32: Connecting A Barcode Scanner (Optional)

     If the battery is deteriorating,the actual battery duration may be shorter. Periodically check the battery. 7.6. Connecting a barcode scanner (optional) After a barcode scanner is connected to the pump, the patient information, such as record No. and hospital No., can be scanned, and the patient information in the pump will update automatically by pump prompts.
  • Page 33: 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. Considering the importance of abnormal information, alarm information is classified into three levels from the viewpoint of security: low-level, mid-level, and high-level alarms.
  • Page 34 Alarm Alarm Causes Troubleshooting Symptoms level no internal battery or the battery. internal battery operates abnormally. Low Battery Mid-level The internal battery is Immediately connect an running critically low. AC power supply or an external power supply. Near End It takes less than three Press [SILENCE] to stop Low-level minutes to complete the...
  • Page 35: Troubles And Troubleshooting

    Alarm Alarm Causes Troubleshooting Symptoms level complete Reminder Alarm Mid-level Forget to operate the Press any key to clear alarm (no key operation the alarm. is made two minutes after installed). 8.3 Troubles and trouble shooting When the device goes wrong, a corresponding trouble code appears in the interface and gives out high-level alarm.
  • Page 36: Maintenance

    Maintenance 9. Maintenance 9.1. Cleaning, Sterilizing  Before cleaning the pump,be sure to turn off the power and disconnect the AC or DC power cables.  If any solution spills on the pump or the pump gets heavily soiled,wipe it with wet soft cloth dampened with cold or lukewarm water.
  • Page 37  No abnormal noise during the peristaltic plate working.  No abnormal noise during the door and the anti-free-flow clamp working  Check all the seal parts, the installation appears to be normal and no material damage. 9.2.2. Checking the Power Cable ...
  • Page 38: Maintenance

    condition is good. If the time from 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 39: Environmental Protection And Recovery

    9.6. Environmental Protection and Recovery At the end of life, please dispose of this equipment to the distributor you purchased the product from or dispose of them by a suitable method according to the applicable environmental laws and regulations.
  • Page 40: Flow Rate Characteristics

    Characteristics of Infusion Accuracy Flow Rate Characteristics The following test is performed in accordance with the IEC60601-2-24 standard. It is used to observe the infusion accuracy and the occlusion response. (For detailed test conditions, see the IEC60601-2-24 standard.) In the following test, we use a 20d/mL IV set of Yusheng. CAUTION: ...
  • Page 41: Occlusion Characteristics

    10.2. Occlusion Characteristics The occlusion characteristics are reflected by the longest delay time to start an alarm. Table11–1 Table of the occlusion level and alarm delay time Occlusion Occlusion Bolus Occlusion pressure alarm time Infusion rate (ml) pressure level (mmHg) (hh: mm:ss)...
  • Page 42 Appendix A Electromagnetic Compatibility (EMC) The SYS-6010 infusion pump conforms to EMC standard EN 60601-1-2. Electromagnet emission instruction and statement The SYS-6010 infusion pump should be used under the regulation electromagnet environment. The user should operate the SYS-6010 infusion pump under following electromagnet environment.
  • Page 43 Electromagnet immunity instruction and statement The SYS-6010 infusion pump should be used under the regulation electromagnet environment. The user should operate the SYS-6010 infusion pump under following electromagnet environment. Immunity IEC60601 Conform level Electromagnet measurement measurement environment-instruction level Electrostatic ±8 kV contact ±8 kV contact...
  • Page 44 >95% U ) <5% U 5seconds (dropping>95% )5seconds Power 3 A/m 400 A/m The power frequency frequency magnetic fields should magnetic fields have a horizontal (50/60Hz) characteristic in typical IEC 61000-4-8 commercial or hospital environment. Note: U refers to AC network voltage before test...
  • Page 45 Electromagnet immunity instruction and statement The SYS-6010 infusion pump should be used under the regulation electromagnet environment. The user should operate the SYS-6010 infusion pump under following electromagnet environment. Immunity IEC 60601 measureme measurem Conform ent level level Electromagnet environment-instruction...
  • Page 46 If the measurement shows that the field intensity of SYS-6010 infusion pump’s operating environment exceeds the regulated RF level, there should be an observation that if the SYS-6010 infusion pump works normally.
  • Page 47 Suggested distance between SYS-6010 infusion pump and potable/mobile RF communication devices The SYS-6010 infusion pump can be used in the environment of which RF interference is under control. To avoid electromagnet interference, users should keep the minimum distance between SYS-6010infusion pump and potable/mobile RF communication devices.
  • Page 48 1ml/h Pressure unit mmHg Occlusion pressure P2(middle level) Near end 3min Yusheng, Medcaptain, B.Braun, Jierui, Longxin, Baoan, Wangguan, Kanglilai, Suyun, Pingan, Built-in consumable brand Oujian, Jianshi, Fuerte, Kangdelai, Shenguang, Tongnuo, Lingyang. System time System time and date The default factory setting Time 00:00...
  • Page 49 Appendix C Toxic and Hazardous Substances or Elements Polybromina Polybromina Chromiu Plumbum Mercury Cadmium ted diphenyl Descriotion m VI biphenyls ethers Cr(VI) PBDE ○ ○ ○ ○ ○ ○ pump shell key and ○ ○ ○ ○ ○ ○ cover ○...
  • Page 50 1.2 The screen lock and remove During infusion, if there is no key or screen operation within the setting time of auto screen lock, it would lock screen automatically and a lock icon appears on the title bar as below MEDCAPTAIN 20d Rate mL/h...
  • Page 51 Click the screen or press any key, the unlock interface appears as below Click [Yes] to deactivate the screen lock and return to the operation interface. The lock icon disappears. Click [No] to return to the operation interface directly and keep the screen locked. If not any operation in 10s, it will return to the operation interface automatically and keep the screen locked.
  • Page 52 2.2 Standby Interface MEDCAPTAIN PL20 Standby time can be set in this interface and the remaining time shows in a countdown way. After the standby finishes, it returns to the operation interface automatically and gives out a middle-level alarm of [Standby Time Expired].
  • Page 53 EU- Representative name: WellKang Ltd EU- Representative address: Suite B, 29 Harley Street LONDON W1G 9QR, England, United Kingdom Telephone: +86-755-26953369 Fax: +86-755-26001651 0123 Postal code: 518000 Website: http://www.medcaptain.com E-mail: info@medcaptain.com Copyright of 2014 Medcaptain Medical Technology Co., Ltd. (V2.0)

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