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MEDCAPTAIN SYS-6010 Operation Manual

Infusion pump
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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 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 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 4 Overview OVERVIEW ....................1 ....................1 NTENDED USE ..................1 ONTRAINDICATION ..................1 RODUCT EATURES PRECAUTIONS FOR USE ................3 PRODUCT SPECIFICATIONS..............7 PRODUCT DESCRIPTION ................9 ................9 RINCIPLE OF PERATION ..............9 OMPOSITION OF NFUSION ....................12 ROP SENSOR ....................12 LAMP ....................13...
  • Page 5 Overview ....................21 UNCTURE ..................21 TARTING NFUSION ..............22 HANGE RATE DURING INFUSION ......................22 OLUS 6.10 S ..................23 TOPPING NFUSION 6.11 R ..............23 EPLACING OR ADJUSTING 6.12 T ................23 URNING THE OWER SETTING THE INFUSION PUMP ............... 25 ..................25 NFUSION SETTING 7.1.1 Infusion mode ....................25 7.1.2 Occlusion Level ...................
  • Page 6 Overview ................34 NTERNAL BATTERY <I ONNECTING TO THE NFUSION ENTRAL ONITORING >( ) ....................35 YSTEM OPTIONAL ) ................36 URSE PAGER OPTIONAL ) ..............36 OICE COMMUNICATION OPTIONAL ) ..........36 ONNECTING A BARCODE SCANNER OPTIONAL 7.10 U ) ...........36 SPECIFIC EQUIREMENTS OPTIONAL 7.10.1 Maximum Flow rate ..................
  • Page 7 Overview ..................43 RANSPORTATION ..........43 NVIRONMENTAL ROTECTION AND ECOVERY INFUSION ACCURACY CHARACTERISTICS ..........44 10.1 F ..............44 HARACTERISTICS 10.2 O ..............47 CCLUSION HARACTERISTICS APPENDIX A ELECTRON MAGNETIC COMPATIBILITY (EMC) ......48 APPENDIX B THE DEFAULT FACTORY SETTINGS ..........54 APPENDIX CTOXIC AND HAZARDOUS SUBSTANCES OR ELEMENTS .... 55...
  • Page 8 1.2 Contraindication None. 1.3 Product Features MEDCAPTAIN SYS-6010 is a micro-continuous infusion pump. It ensures constant infusion speed and accurate dosing volume during long time infusion. This infusion pump is used for continuous and micro-volume infusion of liquid or liquid...
  • Page 9 Overview  Two-way alarm for monitoring the main control circuit and motor drive circuit  Independent motor driving CPU and motor subdivided drive chip design.  Setting and giving automatic prompt of maintenance interval. Note: Pole clamp, barcode scanner, WIFI communication module, voice communication, and nurse function are optional l, depending on the user’s need.
  • Page 10 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. CAUTION: The information is about guiding suggestions.
  • Page 11 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 and the patient simultaneously. CAUTION:  The administration set is treated as the applied part.
  • Page 12 Precautions For Use  Before pressing the [START] key, check if the infusion speed is correct, especially the position of the decimal point.  Occlusion alarm may occur when high-viscosity liquid is infused at high speed through a thin intravenous needle. Increase the occlusion level or decrease the infusion speed.
  • Page 13 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. Collection of such waste separately for special treatment is necessary.
  • Page 14 Product Specifications 3 Product Specifications Product name Infusion pump Model SYS-6010 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 15 Product Specifications Event recording: Can store and playback 2000 events maximum Alarm volume setting: 11 levels of alarm voice 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 16 4 Product Description 4.1 Principle of Operation The SYS-6010 infusion pump mainly consists of the pump shell, display and 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 17 Product Description 1 –Infusion tube slit 2 –Peristaltic pump tablets 3 – Lighting lamp 5 –Catch 6 – Air bubble sensor 4–Depressor 9 –Anti-free-flow clamp 7 –Pressure sensor 8 –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 Product Description  The person who connects the devices and accessories to each other or who uses the devices and accessories is responsible and liable for installation and operation that complies with IEC/EN 60601-1-1 or clause 16 of IEC 60601-1. ...
  • Page 20 Product Description 4.5 Nurse Pager 1 –Button 2 –Cable 3 –Socket 4.6 Accessories accompanied 1 –AC power cord 2 - Pole clamp 3 –Operation manual 4 - Packing list 5 –Quick-operation instruction 1 4.7 Optional Accessories Table 4-1 List of Optional Accessories Options Description Parts code...
  • Page 21 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 22 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 23 Operating Instructions Information area: to display the patient name, record No., bed No., IV set brand and specifications, occlusion pressure level, real-time pressure, external power supply and battery volume. Click the brand and specification area to modify the infusion brand. Click occlusion pressure level or real-time pressure state area to modify the occlusion pressure level.
  • Page 24 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 25 Operating Instructions WARNING:  After booting, check if the buzzer, alarm indicator are successfully self-checked and without error alarms (error alarms see chapter 8 Troubleshooting in this manual).  Ensure the displayed IV set brand corresponds with the using IV set brand. ...
  • Page 26 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 27 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 28 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 29 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 30 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 The minimum bolus The maximum bolus (d/ml) rate(ml/h) volume(ml) volume(ml) 0.1-1200.0 50.0 CAUTION: ...
  • Page 31 Operating Instructions  Click [Power Off] to shutdown.  Click [Standby] to enter standby interface, the standby time can be modify.  Click [Cancel] to return to previous interface. 24 / 55...
  • Page 32 Setting the Infusion Pump 7 Setting the Infusion Pump CAUTION:  After shutting down the pump, all parameter settings will be automatically saved.  Parts of parameters will not be saved in force shutdown. 7.1 Infusion setting Press [HOME] key to enter the setting interface, click [Infusion Set] to enter the detailed infusion setting interface.
  • Page 33 Setting the Infusion Pump  BodyWeight mode Under the Body Weight mode, set the concentration, VTBI, doserate and body weight, automatically calculate the rate, and then click [Confirm] to operate..  Sequence Mode Under the Sequence Mode, set the drug name, 10 sequence rate and time, click [Confirm] to operate in sequence.
  • Page 34 Setting the Infusion Pump CAUTION:  According to the setting drop rate (dots/min) and current selected IV set (20d/ml), the infusion pump transfers drop rate (dots/min) to corresponding rate(ml/h) and controls the flow rate.  Under the drip mode, the infusion pump controls flow rate (ml/h), not drip (dots/ml). 7.1.2 Occlusion Level levels of occlusion are available (Factory setting is level 2).
  • Page 35 Setting the Infusion Pump or slowdown the infusion rate. 7.1.3 KVO Rate  The adjustable range of KVO is 0.1 - 5ml/h（stepping 0.01ml/h）,default 1ml/h; 7.1.4 Brand  You can choose the consumable brand by: [Home] -> [Infusion Set] -> [Brand] ...
  • Page 36 Setting the Infusion Pump  volume levels are available (The factory setting is level 5). CAUTION:  Do not set an alarm volume that is lower than the environment noise, or it may cause the alarm system to be out of work or the alarm cannot be correctly recognized timely. ...
  • Page 37 Setting the Infusion Pump  Click [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 could be set.  Choose [Station WLAN] to use station WLAN channel to connect to the network, and the station WLAN parameters could be set.
  • Page 38 Setting the Infusion Pump  Click [ScreenLock Password] to enable/disable the screen lock password function. When the function is enable, a password is required to unlock the screen. When the function is disable, there will be no require on password to unlock the screen. ...
  • Page 39 Setting the Infusion Pump 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  In the [Maintenance], users can operate items like Language Select, Touch Adjust, Factory Data Reset and check the Version Info. ...
  • Page 40 Setting the Infusion Pump 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 Occurred time, rate, accumulated volume Occurred time, accumulated volume, KVO rate...
  • Page 41 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 42 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 43 Setting the Infusion Pump Caution：  Infusion pump cannot be operated through the < Infusion Central Monitoring System >. 7.7 Nurse pager (optional) After infusion pump is connected to the central station, patient can press nurse pager in bed, and then the central station in nurse station would gives out sound tip and display patient’s information in screen, so that the nurse can take care of the patient in time.
  • Page 44 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 45 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 46 Troubleshooting Alarm Symptoms Alarm level Causes Troubleshooting abnormal. sensor installation. No Drop Sensor Mid-level During infusion, the drip Install the drop sensor or detection function is turned stop infusion and turn off on without drop sensor. the drip detection function. No Drop High-level During infusion, the drop...
  • Page 47 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 there is dirt on the pump，wipe it with wet soft cloth dampened with cold or lukewarm water.
  • Page 48 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 6 months by the graduate and timer.
  • Page 49 Maintenance  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. Replace the battery. You are advised tocontact manufacturer or manufacturer’s representative to replace the battery. ...
  • Page 50 Maintenance which it is intended.  If the infusion pump is dropped or subjected to impact，remove it from service even if it doesn’t appear damaged externally. Request the manufacturer or manufacturer’s representative to inspect it for a possible internal problem. CAUTION: ...
  • Page 51 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 52 -0.94 Minimum rate 1ml/h，normal condition Intermediate rate 25ml/h，normal 1.26 condition Intermediate rate 25ml/h，with -0.18 +13.3kpa back pressure Medcaptain 20d/mL Intermediate rate 25ml/h，with -0.57 -13.3kpabackpressure Intermediate rate 25ml/h，when the -10.07 supply container below the pump mechanism at a distance of 0.5m CAUTION: ...
  • Page 53 Infusion Accuracy Characteristics  Table 10-2 Accuracy test result Start-up curves of MC 25mL/h Start-up curves ofMC 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 ofB.Braun 1mL/h Trumpet curve of B.Braun 25mL/h Trumpet curve of B.Braun 1mL/h 46 / 55...
  • Page 54 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 The SYS-6010 infusion pump conforms to EMC standard EN 60601-1-2. Guidance and manufacturer’s declaration – electromagnetic emissions 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 56 Guidance and manufacturer’s declaration – electromagnetic immunity The [SYS-6010] is intended for use in the electromagnetic environment specified below. The customer or the user of the [SYS-6010] should assure that it is used in such an environment. IMMUNITY test IEC60601test level...
  • Page 57 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 AC. mains voltage prior to application of the test level. 50 / 55...
  • Page 58 Guidance and manufacturer’s declaration – electromagnetic immunity The [SYS-6010] is intended for use in the electromagnetic environment specified below. The customer or the user of the [SYS-6010] should assure that it is used in such an environment. IEC 60601 Immunity...
  • Page 59 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the [SYS-6010] is used exceeds the applicable RF compliance level above, the [SYS-6010] 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].
  • Page 60 Recommended separation distances between portable and mobile RF communications equipment and the [SYS-6010] The [SYS-6010] is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the [SYS-6010] can help prevent...
  • Page 61 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 62 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 63 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: 518000 Website: http://www.medcaptain.com E-mail: info@medcaptain.com Copyright of 2016 Medcaptain Medical Technology Co., Ltd. (V2.1)