MEDCAPTAIN SYS-6010 User 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.
Operation Manual
Infusion Pump SYS-6010

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).
©2015-2016 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.
, MEDCAPTAIN and are registered trademarks or trademarks of
MEDCAPTAIN.
Statements
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.
MEDCAPTAIN is responsible for safety, reliability and performance of this equipment only
in the condition that:
Use in accordance with the Operation manual.
All disassembly, replacement, test, modification and repair are executed by qualified
personnel approved by MEDCAPTAIN.
All replacement parts, supporting accessories and consumables during the
maintenance are provided by MEDCAPTAIN.
Maintenance records for product are reserved.
Version Information
V1.0
Firstly publish
Publish date：2013.12.30
V2.0
Registration change and content modification
Publish date：2014.5.30
V2.1
Interface Modification
Publish date：2016.3.5

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.
Irresistible natural disasters.
Replace or use parts, accessories and consumables without approval of
MEDCAPTAIN.
Other troubles not caused by product itself.
After the warranty period, we continue to provide charged maintaining service. If you have
any question when using the infusion pump, please contact local distributor or directly contact us
at any time.
The after-sales service contact details of Medcaptain Medical Technology Co., Ltd. are as
follows:
Address: 12th Floor, Baiwang Research Building, No.5158 Shahe West Road, Xili,
Nanshan District, Shenzhen, P.R.China
Telephone:[phone]
Fax: [phone]
Postal: 518055
Website: http://www.medcaptain.com
E-mail:[e-mail]
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. and all local dealers established
after-sales service agencies, can effectively, timely solutions to your problems.
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.

Overview
1OVERVIEW.................................................................................................. 1
1.1 INTENDED USE ............................................................................................... 1
1.2 CONTRAINDICATION........................................................................................ 1
1.3 PRODUCT FEATURES...................................................................................... 1
2PRECAUTIONS FOR USE ........................................................................... 3
3PRODUCT SPECIFICATIONS...................................................................... 7
4PRODUCT DESCRIPTION........................................................................... 9
4.1 PRINCIPLE OF OPERATION .............................................................................. 9
4.2 COMPOSITION OF INFUSION PUMP ................................................................... 9
4.3 DROP SENSOR ..............................................................................................12
4.4 POLE CLAMP ................................................................................................12
4.5 NURSE PAGER..............................................................................................13
4.6 ACCESSORIES ACCOMPANIED.........................................................................13
4.7 OPTIONAL ACCESSORIES ...............................................................................13
5PREPARATIONS FOR USE ....................................................................... 14
6OPERATING INSTRUCTIONS ................................................................... 15
6.1 DISPLAY AND KEYS ........................................................................................15
6.2 START UP .....................................................................................................17
6.3 IV SET INSTALLATION .....................................................................................18
6.4 PURGE .........................................................................................................20
6.5 SETTING THE INFUSION RATE..........................................................................20

Overview
6.6 PUNCTURE ...................................................................................................21
6.7 STARTING INFUSION ......................................................................................21
6.8 CHANGE RATE DURING INFUSION ....................................................................22
6.9 BOLUS .........................................................................................................22
6.10 STOPPING INFUSION ......................................................................................23
6.11 REPLACING OR ADJUSTING IV SET ..................................................................23
6.12 TURNING THE POWER OFF.............................................................................23
7SETTING THE INFUSION PUMP ............................................................... 25
7.1 INFUSION SETTING.........................................................................................25
7.1.1 Infusion mode ..............................................................................................25
7.1.2 Occlusion Level ...........................................................................................27
7.1.3 KVO Rate.....................................................................................................28
7.1.4 Brand............................................................................................................28
7.1.5 Drip Detection..............................................................................................28
7.1.6 NearEnd .......................................................................................................28
7.2 SYSTEM SET.................................................................................................28
7.2.1 Volume Setting ............................................................................................28
7.2.2 Display SET.................................................................................................29
7.2.3 Internet Set...................................................................................................29
7.2.4 Lock screen Set............................................................................................30
7.2.5 Collection Set...............................................................................................31
7.2.6 Linkage mode...............................................................................................31
7.2.7 PressureUnit.................................................................................................31
7.2.8 Date&Time set.............................................................................................32
7.2.9 Maintenance.................................................................................................32
7.3 HISTORY ......................................................................................................32
7.4 PATIENT FILE................................................................................................33

Overview
7.5 USE INTERNAL BATTERY ................................................................................34
7.6 CONNECTING TO THE <INFUSION CENTRAL MONITORING
SYSTEM>(OPTIONAL) ...............................................................................................35
7.7 NURSE PAGER (OPTIONAL).............................................................................36
7.8 VOICE COMMUNICATION(OPTIONAL) ................................................................36
7.9 CONNECTING A BARCODE SCANNER (OPTIONAL) ..............................................36
7.10 USER-SPECIFIC REQUIREMENTS (OPTIONAL) ...................................................36
7.10.1 Maximum Flow rate.....................................................................................36
8TROUBLESHOOTING................................................................................ 37
8.1 ALARM .........................................................................................................37
8.2 FAULTS AND TROUBLESHOOTING....................................................................38
8.3 TROUBLES AND TROUBLE SHOOTING ...............................................................39
9MAINTENANCE ......................................................................................... 40
9.1 CLEANING,STERILIZING.................................................................................40
9.2 PERIODIC MAINTENANCE ...............................................................................40
9.2.1 Checking the Appearance............................................................................40
9.2.2 Checking the Power Cable...........................................................................40
9.2.3 Checking the infusion rate...........................................................................41
9.2.4 Alarm ...........................................................................................................41
9.2.5 Electric and mechanical safety.....................................................................41
9.2.6 Checking the Internal Battery......................................................................41
9.2.7 Replacing the Battery...................................................................................42
9.3 MAINTENANCE ..............................................................................................42
9.4 STORAGE .....................................................................................................43

Overview
9.5 TRANSPORTATION .........................................................................................43
9.6 ENVIRONMENTAL PROTECTION AND RECOVERY ...............................................43
10 INFUSION ACCURACY CHARACTERISTICS ............................................ 44
10.1 FLOW RATE CHARACTERISTICS ......................................................................44
10.2 OCCLUSION CHARACTERISTICS ......................................................................47
APPENDIX A ELECTRON MAGNETIC COMPATIBILITY (EMC)........................... 48
APPENDIX B THE DEFAULT FACTORY SETTINGS............................................ 54
APPENDIX CTOXIC AND HAZARDOUS SUBSTANCES OR ELEMENTS ............ 55

Overview
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1Overview
1.1 Intended use
This product is intended for hospitals to infuse liquid at constant-speed or liquid
medicine continuously through the veins of patients.
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
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.
All current disposable IV sets conform to the standard are supportable.
New IV set conform to the standard can be customized.
Providing three occlusion levels and displaying pressure status of the tube.
Maximum infusion rate can be set to 1200mL/h.
Calibration functions for infusion accuracy is available.
Safety design by monitoring infusion states.
Multiple modes of infusion.
Configure with multi-channel infusion workstation, realizing relay infusion function.
WIFI module could be connected to the ICMS to monitor the infusion status.
Nurse call function.
Voice Communication function.
Touchscreen, providing quick and convenient man-machine interface.
Display night mode, reducing light interference to patients and environment.
Connection to barcode scanner function.
Three types of power supply: AC power supply, DC power supply, and internal lithium
battery are available. The lithium battery can power the infusion pump for no less
than 5 hours (at 25ml/h rate).
Double CPU and redundancy design for key units.

Overview
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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.

Precautions For Use
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2Precautions 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. Operation against the caution may
affect normal use of the product. Read carefully the warnings and cautions in this manual.
WARNING
The infusion pump must be operated by clinical professionals.
The infusion pump cannot be used to transfer blood.
Prior to use, carefully check the pump, power cord and accessories, to ensure the
normal operation and safety.
Pay extra attention to kinks of the infusion line when it is used for low-infusion. The
smaller the set infusion rate becomes, the longer it takes from the occurrence of
occlusion to its detection, which may suspend the infusion for a long time.
Do not use the infusion pump in the environment of flammable anesthetic gas or rich
oxygen.
The height difference between infusion pump and patient should less than 100cm.
The lower of the height difference is, the pressure testing of the infusion tube is more
accurate.
In the event of tube twisting, filter condensation or intubation occlusion during infusion,
the internal pressure of the infusion tube will increase. Once the causes for occlusion
are removed, too much infusion liquid may be infused into the patient. Therefore,
proper actions should be taken. For example, clamp the infusion tube before
removing the occlusion causes.
The infusion pump must be used with the recommended IV set to ensure the infusion
accuracy and alarm function.
Only the IV set, tube, infusion needle and other medical parts complying with the local
regulations can be used on the infusion pump. Contact your local distributor for more
information.

Precautions For Use
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Operations against the requirements, procedures, warnings and cautions provided in
this manual may cause infusion failure, inadequate over dosing, or other potential
risks.
It is recommended to install the drop sensor and open the drop monitoring function. A
long time extrusion may cause without moving or replacing the tube an inadequate
infusion.
There should be a regular monitoring to patient’s real clinical situation and
performance of the pump, by clinical professionals.
Place the power cord and cables of accessories carefully, avoiding cable tangle,
patient winding or electrical interference.
High-frequency surgical equipment, mobile phone, wireless device and defibrillator
may have interference on the infusion pump. Keep away from such devices while
operating.
To avoid the risk of electric shock, this equipment must only be connected to supply
mains with protective earth.
The infusion pump and accessories near to service life time must be scrap according
to local regulations or hospital rules. If there is any problem, please contact the
distributor or manufacturer.
Do not modify this equipment without authorization of the manufacturer.
When operating the pump or checking the pump's alarm system, the operator shall
be in front of the device, no farther than 1 meter.
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.
Check the setting values on the prescription and infusion pump. , the infusion can be
started without moving or replacing the tube.
In order to prevent extra infusion, close the rolling clamp of the IV sets before
separating the IV sets from pump.
Follow the tube replacement alarm on the display, replace the IV sets or move the IV
sets tubing to more than 10cm, so as to keep the infusion accuracy continuously.
Please properly install or carry the infusion pump, avoiding device damage through
crash, fall, violent mechanical vibration or other external force.

Precautions For Use
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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.
Infusion pump should be placed without the reach of patients and other irrelevant
personnel.
Be away from direct sunshine, high temperature and high humidity.
Do not disinfect the infusion pump by using high-pressure steam sterilization method.
Before using the internal battery, check the battery to ensure that sufficient power is
available. Recharge, if required.
Ensure that the infusion pump always has a battery installed during operation.
Otherwise, the system may stop without issuing an alarm when external power is
interrupted due to power failure or a short circuit, causing an unsafe condition.
If the infusion pump cannot work as described in this manual for unknown reasons,
stop it and report the details (including IV set, infusion flow, serial number of infusion
pump, and type of infusion liquid) to your local distributor or our customer service
department.
Do not operate on the display using sharp objects. It may damage the screen..
Do not disassemble or reconstruct the infusion pump without authorization.
Liquid intrusion into the AC power socket, USB or nurse call socket may cause
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 wiper. Use after
the service engineer checking.
Applied parts administration set, which is not intended to deliver heat, during normal
use the maximum temperature at applied part maybe up to 40.4°C.
Before use, carefully check if the occlusion pressure test function of the infusion
pump is normal. The Maximum infusion pressure at the end of the infusion tube
generated by the pump may be up to 3500mmHg under the condition of occlusion
when sensor failed.
When the infusion pump is working, the delay time from alarm triggered to give out
alarm information is less than 150ms.

Precautions For Use
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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.
CAUTION! Read the accompanying document.
General warning sign
Refer to instruction manual / booklet
IPX2
Level of protection from liquid intrusion
Interference may occur near the devices with below sign.
Nurse call
ON/OFF
HOME
OPEN

Product Specifications
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3Product Specifications
Product name
Infusion pump
Model
SYS-6010
Power supply
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
Battery model: 154457
Time of battery continuous use: no less than 5 hours (for infusion at
25 mL/h rate with a new battery)
Fuse
T1.6AL 250VAC
Compatible IV sets
All 20d/ml disposable IV sets conform to the standard, 20d/mL
Infusion mode
Rate, Time, Body Weight, Sequence, Micro, Relay, Drip Mode
Infusion setting range
0.1-1200.0mL/h or（0.03-400d/min）(20d/Ml IV set)
See the least increment in chart 6-3
VTBI setting range
0.1 - 99.99（Least increment 0.01）
100 - 999.9（Least increment 0.1）
1000 - 9999（Least increment 1）
Total volume display
0-99999.99ml
Accuracy
±5%
Purge operation
1200.0ml/h(20d/ml IV set)
Bolus operation
0.1~1200.0ml/h(20d/ml IV set)
Automatically calculate the bolus rate by bolus amount, cannot
lower than the current rate.
KVO rate
0.1-5.0mL/h
Air-bubble sensor
Sensitivity: detect air-bubble ≥
Occlusion level
300mmHg~900mmHg，3 levels are available
Alarm
Near End, Infusion End, Occlusion Alarm, Low Battery, Battery
Empty, No Battery, No Power Supply, Door Open, No Drop Sensor,
No drop, Drop Error, Air Bubble, Reminder Alarm and Standby
Finish.
Special function
Repeat alarming: If there is still alarm after mute alarm sound, it
will alarm again in 2 minutes

Product Specifications
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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
WIFI function
Connect infusion workstation, nurse pager, voice communication
and infusion pump information network
Operating conditions
Ambient temperature: 5℃-40℃Relative humidity: 15%-95%, no
condensation Atmospheric pressure: 70.0 kPa-106.0 kPa
Storage conditions
Ambient temperature: -20℃-55℃Relative humidity: 10%-98%, no
condensation Atmospheric pressure: 22.0 kPa-107.4 kPa
Classification
1. Class I / Internally powered equipment;
2. Type CF applied part;
3. IPX2;
4. No sterilization requirement for pump
5. Not category AP / APG equipment;
6. Mode of operation: continuous
Dimensions
100(W) ×230 (H) ×190(D)mm
Weight
About 1.2 kg (including battery)
Manufacture date
See label in the bottom of the device
Main safety standards
IEC60601-1 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
IEC60601-2-24 Medical electrical equipment –Part 2-24: Particular
requirements for the safety of infusion pumps and controllers
IEC60601-1-8 Medical electrical equipment -- Part 1-8: General
requirements for basic safety and essential performance --
Collateral standard: General requirements, tests and guidance for
alarm systems in medical electrical equipment and medical
electrical systems
IEC60601-1-2 Medical electrical equipment - Part 1-2: General
requirements for basic safety - Collateral standard: Electromagnetic
compatibility requirements and tests

Product Description
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4Product 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).
The infusion pump adopts the dual processor structure, controls the motor precisely,
drives the peristaltic sheet to infuse through the mechanical drive device, monitors the
sensors and infusion process, and provides sound and light alarms.
4.2 Composition of Infusion Pump
1 –Touchscreen
2 –[HOME]key
3 –[ON/OFF]key
4 –[OPEN]key
5 –pump door
6 –Shell
7 –Alarm indicator
8 –Drop sensor holder

Product Description
10 / 55
1 –Infusion tube slit
2 –Peristaltic pump tablets
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
Infusion tube slit. At sides of pump to guide the infusion tube in a line behind the
pump door.
Depressor and peristaltic plate. Driven by the step motor, press and move the tube to
realize liquid flow.
Lighting lamp. To provide lighting in a dim environment, so as to install and check the
infusion tube.
Catch. The two catches are used to close the pump door.
Pressure sensor and bubble sensor. Sensors monitor occlusion pressure and air
bubble inside the infusion tube.
Anti-free-flow clamp. Stop liquid flow and infusion backwards after the pump door
opens.
Anti-free-flow clamp button. Press the button and the clamp will automatically open or
close.

Product Description
11 / 55
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. To fix the pole clamp, then fix the pump to the IV pole via the pole
clamp.
Buzzer. To alarm in high, medium or low level during infusion and enable voice
conversation.
Auxiliary alarm. Audible alarm sounds when product functions abnormally.
AC power inlet. To connect the external AC power source.
External inlets 1, 2 and 3. The three inlets share the same signal and can be
connected to 2 external devices at the same time. The external devices include drop
sensor, barcode scanner, and external DC power
CAUTION:
Only the accessories or devices specified by the manufacturer allowed to be
connected to the Pump. Otherwise may cause electrical shock. See Table 4-1.

Product Description
12 / 55
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.
The plug is used as disconnect to the mains supply, do not position the pump so that
it is difficult to operate the disconnection device..
4.3 Drop sensor
3
2
1
4
1 –Button
2 –Drip hole
3 –Cable
4 –Socket
4.4 Pole Clamp
12
1 - Mounting screw
2 - Mounting knob of infusion stand

Product Description
13 / 55
4.5 Nurse Pager
1 –Button
2 –Cable
3 –Socket
4.6 Accessories accompanied
1 –AC power cord 1
2 - Pole clamp 1
3 –Operation manual 1
4 - Packing list 1
5 –Quick-operation instruction 1
4.7 Optional Accessories
Table 4-1 List of Optional Accessories
Options
Description
Parts code
Power cable
Standard configuration by factory
7000000005
Lithium battery pack
11.1V@1500mAh
7404000006
Nurse pager
MP-2
9113001002
Drop sensor
MP-3
9114002521
Barcode scanner
MP-4
9005000008
Pole clamp
——
9114002501