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Operation Manual
Please read this Operation Manual carefully and follow Precautions for Use and
Preparations for Use before using the SYS-3010 Syringe Pump.
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.
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 conducted 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
The manual is subject to change without further notice. Please contact local distributor or
directly contact us for the latest information.
V1.1
Service interval modification and writing mistake correction
Publish date2016.7.30
After Service
Thank you for using the syringe 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. To protect your rights, please fill in Product Warranty Card after the device
installation, give the second union (the Company retained union) of warranty card to
installer or mail it back to customer service department of MEDCAPTAIN MEDICAL
TECHNOLOGY CO., LTD.
Attention: the following cases are not included in warranty
Without filling in and returning Product Warranty Card within 30 days after the
installation.
The serial number provided is incorrect.
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 syringe 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: 0755-26953369
Fax: 0755-26001651
Postal: 518055
Website: http://www.medcaptain.com
E-mail:info@medcaptain.com
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. and all local dealers established
after-sales service agencies, can effectively, timely solutions to your problems.
After Service
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.
Content
1 OVERVIEW .................................................................................................. 1
3 PRODUCT SPECIFICATIONS...................................................................... 6
8 TROUBLESHOOTING................................................................................ 36
9 MAINTENANCE ......................................................................................... 39
1.2 Contraindication
None.
1 / 54
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. Operation against the precautions may
affect normal use of the product. Read carefully the warnings and cautions in this manual.
WARNING:
2 / 54
Precautions For Use
local regulations can be used on the syringe pump. Contact your local distributor for
more information.
Operating the syringe pump against the requirements, procedures, warnings and
cautions provided in this manual may cause infusion failure, inadequate or over
dosing, or other potential risks.
There should be a regular monitoring by clinical professionals when using the device.
The power cord or other affiliated lines should be kept properly to avoid any risk of
twining on patient or electrical disturbance.
Electric equipment like high-frequency electric scalpel and mobile phone may have
electromagnetic interference on the syringe pump.
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
If the pump and its related accessories are reaching over the life time, they must be
crapped and disposed in accordance with the local laws or hospital
ordinances.Please contact your local representative for further details.
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-3010 and the patient simultaneously.
CAUTION:
The infusion set is treated as the applied part of the pump.
Check the setting values on the prescription and the syringe. Infusion can start only
when the values are equal.
Ensure that the syringe pump has been fixed tightly on the stand and the stand is
stable.
Prevent the pump from collision, dropping mechanical vibration or other impact of
external forces to avoid damage on the pump.
Before pressing the [START/STOP] 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
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Precautions For Use
through a thin intravenous needle. Increase the occlusion level or decrease the
infusion speed.
Syringe pump should be placed without the reach of patients and other irrelevant
personnel.
Avoid direct sunlight, high temperature and high humidity.
Do not sterilize the syringe pump by using the high-pressure steam sterilization
method.
Before internal battery operation, check the battery to ensure that sufficient power is
available. Recharge, if required.
Ensure that the syringe pump always has a battery installed during operation.
Otherwise, the system may stop without issuing an alarm when external power is
interruption due to power failure or a short circuit, causing an unsafe condition.
If the syringe pump cannot work as described in this manual for unknown reasons,
stop it and report the details (including syringe, infusion flow, serial number of syringe
pump, and type of infusion liquid) to your local distributor or our customer service
department.
Do not disassemble or reconstruct the syringe pump.
Liquid intrusion into the AC power socket, RS-232 socket may cause short-circuiting.
While connecting the power cable, check if the connecting parts are dry. If liquid spills
on the syringe pump, clean the pump with a dry cloth. Use after the service engineer
checking.
The maximum temperature at the applied part of the pump maybeup to 42.7, when
running continuously under the highest environment temperate at the highest infusion
rate.
Before use, carefully check if the occlusion pressure test function of the pump is
normal .The Maximum infusion pressure at the end of the infusion tube generated by
the pump may be up to 3000mmHg under the condition of occlusion when sensor
failed.
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Precautions For Use
Symbols:
Date of manufacture.
Manufacturer
Alternating current
Direct current
ON/OFF
START/STOP
5 / 54
Product Specifications
3 Product Specifications
Product name Syringe pump
Model SYS-3010
AC power supply: AC 100-240V,50/60 Hz, power consumption less
than 30 VA
External DC power supply: DC 12 V 1A
Power supply Internal battery: lithium battery 11.1 V 1500 mAh
Battery model: 154457
Time of continuous use: no less than 8 hours (for infusion at 5 mL/h
with a new battery)
Fuse T1.6AL 250VAC
Compatible syringes All syringes of 10ml,20ml,30ml,50ml conform to the standard
Infusion mode Rate,Time,Weight
0.1-300.0ml/h(10ml syringe)
0.1-600.0ml/h(20ml syringe)
Infusion setting range 0.1-900.0ml/h(30ml syringe)
0.1-2000.0ml/h(50ml syringe)
the least increment is 0.1 ml/h
VTBI setting range 0.1-9999.9ml
Total volume display 0.1-9999.9ml
Accuracy Mechanical accuracy: 1% Accuracy including syringe: 2%
KVO rate 0.1~2.5ml/h
3levels are available:
300100mmHg40.013.3kPa
Occlusion level
500100mmHg66.713.3kPa
800200mmHg106.726.7kPa
Purge operation 300.0ml/h(10ml syringe)
600.0ml/h(20ml syringe)
900.0ml/h(30ml syringe)
1500.0ml/h(50ml syringe)
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Product Specifications
Bolus operation 300.0ml/h(10ml syringe)
600.0ml/h(20ml syringe)
900.0ml/h(30ml syringe)
1500.0ml/h(50ml syringe)
Alarm Near Finished, Finished, Syringe Empty, Near empty, Occlusion,
Low Battery, Battery Empty, No Battery, No Extra Power Supply,
Syringe Loose, limit less than total, Invalid Rate, Reminder Alarm
Special function Repeat alarmingIf there is still alarm after mute alarm sound, it
will alarm again in 2 minutes
Event recordingcan store and playback 300 events maximum
Sound volume3 levels are available
Power supply switching: When AC/DC power supply is cut off ,the
infusion automatically switch to internal battery supply
Operating conditions Temperature: 5 to 40 Humidity:15% to 95% RH
Pressure altitude: 70.0kPa-106.0kPa
Storage and Shipping Temperature: -20 to +55 Humidity: 10% to 93% RH
conditions Pressure altitude:22.0kPa-107.4kPa
Classification 1. Class I / Internally powered equipment;
2. Type CF applied part;
3. IPX4;
4. No sterilization requirement for pump
5. Not category AP / APG equipment;
6. Mode of operation: continuous
Dimensions 320(W) 118(H) 120(D)mm
Weight About 2 kg (including battery)
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
7 / 54
Product Specifications
requirements for basic safety - Collateral standard: Electromagnetic
compatibility requirements and tests
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Product Description
4 Product Description
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Product Description
3 Handle 4 Label
CAUTION:
Do not insert the accessories which are not specified by the manufacturer into the
external inlets.
Do not install the pump to the position which is difficult to disconnect the AC power
cord.
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Product Description
4.4.1[AC/DC]indicator
Lights on when the pump operates on AC or DC power.
Goes off when the pump operates on the internal battery
4.4.2[Operate/Alarm]indicator
The green indicator indicates the working status. Flashing means infusion in progress.
Going off means infusion stopped.
The yellow indicator indicates alarms. Lighting means low-level alarms, and flashing
means mid-level alarms.
The red indicator indicates alarms. Flashing means high-level alarms
4.4.3LCD Display
Displays the flow rate, limit value and total volumepower supply status alarm
message.
Displays other message, e.g. message about syringe pump
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Product Description
4.4.4Introduction of keys
Table 4-1 shows the keys and their descriptions.
Table 8-1 Introduction of keys
Key Description
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Product Description
4.5 Accessories
1 AC power cord 1 2 - Pole clamp 1
CAUTION:
Considering the safety, please use specified multi-function cable to connect the
multi-function interface.
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Preparations For Use
5 Preparations for Use
Before using the syringe pump, read carefully the Operation Manual and precautions
in this manual.
When using the syringe pump for the first time, set up the date and time to ensure
that history can be recorded correctly.
Before using the syringe pump for the first time, set the brand of syringe pump.
Before using the syringe pump for the first time, recharge the internal battery fully. If
the syringe pump is off, the battery can be charged fully at least 10 hours after being
connected to an external power supply.
Place the syringe pump on a stable platform.
Or use the provided pole clamp to mount the syringe pump on an infusion stand.
Put the syringe pump on the pole clamp while aligning the retaining knob with the
threaded hole, and rotate the handle to fix the syringe pump on the pole clamp.
Clamp the pole clamp on the infusion stand, adjust the syringe pump to an
appropriate position, and tighten the retaining knob for infusion stand on the pole
clamp.
Connect external power supply.
Insert the supplied AC power cord into the AC inlet on the right side of the
syringe pump. Plug the cord into an AC power outlet with grounding terminal.
To power the syringe pump with external DC power supply, contact your local
distributor for help.
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Operating Instructions
6 Operating Instructions
The LCD Display shows the brand name of the syringe for 2 seconds, for example,
MC.
== Syn Brand ==
MC
The LCD Display shows the rate 0000.0battery volumesize of syringeAC power
status and occlusion level.
AC
50
II
mL/h
CAUTION:
Power on and then install the syringe.
WARNING
After the power switch is turned on, confirm the loudspeaker and indicator working all
right, and check if the self-test is finished and no error messages appear. (Refer to
Chapter 8 Troubleshooting.)
Ensure the displayed syringe brand corresponds with the used syringe brand.
If the syringe brand set is different from the used syringe brand, the infusion accuracy
and alarm function cannot be guaranteed.
If any irregularity is detected, stop operating and contact your local distributor.
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Operating Instructions
6.2 Icons illustration
6.2.1Battery icon
Indicates the occlusion pressure degree in the patient line.See table 6-1
Table8-1Occlusion status indication
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Operating Instructions
6.3 Loading Syringe
Pull the clamp upward (arrow ), and turn it (arrow ).
Rotate
Clamp Pull
upwards
Press the slider clutch and move the slider fully to the right
Connect the syringe filled with liquid to the infusion tube
WARNING:
Ensure that the syringe contains no air bubbles
Slit
WARNING:
If the flange of the syringe is not properly engaged in the slitflow rate accuracy and alarm
functions cannot be guaranteed.
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Operating Instructions
Press the clutch(arrow ), and move the slider until the contact pin of the slider hits
the syringe plunger.
Turn back the clampand lower it slowly to hold the syringe securely.
When the clamp is released, the syringe pump automatically identifies the syringe
size.
6.4 Purging
WARNING:
After loading a syringe on the syringe pump, remove the air bubbles from the syringe
and the IV line.
Before purging the IV line, ensure that the IV line is not connected to patient.
Priming can be done only in non-infusion process.
Press and hold the [PURGE] key to prime the infusion. The LCD display shows the
total volume. Release the [PURGE] key to stop the Purge/bolus operation and the
total value appears for4 seconds.
The purging rate varies depends on the syringe size. Refer to the Table 6-2.
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Operating Instructions
Table 8-2 Relationship between syringe size and purge/bolus rate
CAUTION:
When high viscosity IV fluids are infused through thin vein needle by bolus operation,
occlusion alarm may occur. In such conditions, perform infusion at infusion rate below
150 mL/h instead of bolus operation.
The volume used for priming will be added to the total volume delivered
The fast forward function can be used to remove any mechanical gap. Otherwise,
may cause considerable delay in the start of the infusion.
Total volume cannot be cleared after infusion starts.
The volume under the fast forward function will not be calculated into the total
volume.
CAUTION:
When the [START/STOP] key is pressed while the setting flow rate exceeds the
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Operating Instructions
upper limit or is 0, infusion cannot be started and issuing the alarm Invalid rate. Set
up the flow rate according to Table 6-3.
If a syringe of different size is installed, the flow rate will be zeroed.
The flow rate cannot be set and changed while the pump is infusing.
To change the flow rate in the infusion process, STOP the infusion, then change the
flow rate, and then START again
CAUTION:
During infusion, the total volume cannot be zeroed.
BrandMC Size50mL
Rate100.0mL/h Occ II
Then press the [START/STOP] key again to start infusion at the setting rate.The
green LED indicator will flash.
CAUTION:
Infusion can only start when the recipe value equals to the set value.
If no operation is performed after syringe installation for more than 2 minutes,
START-REMINDER alarm sounds.
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Operating Instructions
6.8 Bolus
During infusion, press [START/STOP] key to STOP infusion, and then press and hold
the [PURGE] key to get the bolus infusion. Release the [PURGE] key to stop the
bolus infusion.
See Table 8-2 Relationship between syringe size and bolus rate.
CAUTION:
WARNING:
In order to prevent inadequate infusion due to stopping infusion unexpectedly, regularly
observe the status of the infusion line and syringe pump.
CAUTION:
To guarantee the infusion safety, if different size syringe is replaced, the flow rate will
be zeroed, please repeat the steps in sections !3 and !
7 and set the flow rate again.
Count Down
21 / 54
Operating Instructions
Limit0000.0mL
Clr By PressClear1s
Use the number adjusting keys to adjust the numbers.
The flow rate is displayed again after 4 seconds.
Press the [RATED.LIMITmL] key to check the setting D.LIMIT volume.
CAUTION:
To change the D.limit volume in the infusion process, stop the infusion and change
the limit volume.
If the D.limit volume is less than or equal to the total volume, infusion cannot be
started.
Mode Sel: select the infusion mode, including rate (speed) mode,time mode and
weight mode.
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Operating Instructions
Occ. Lev: select the occlusion level, including I,II,III.
Bra. Sel: select the syringe brand.
Vox Set: set the alarm volume;
His View: view the history record.
KVO Set: set the KVO( keep vein open) rate, 0.1~2.5mL/h adjustable.
Maintena: pump system maintenance.
Pwd Set: password setting.
Press []/[]/[<]/ [>]key to select the item.The arrow will shift to the item.Press
[RATED.LIMITmL] key to enter the item setting.
For example, select Mode Sel, and press [RATED.LIMITmL] key to enter the
item setting menu, the following interface will be displayed.
Speed Time
Weight
Speed Time
Weight
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Operating Instructions
Time: The expected infusion time(unit:min or h:min, for example:0~9999min or
99h60min).
Limit: The expected infusion liquid volume (unit:mL);
Rate: The automatically calculated flow rate(unit:mL/h)
Press[]/[]key to select the unit min or h:min;
Table8-2 time mode parameter
Item Range Unit Increament
1-9999 min 1min
time
0~99:1~59 hr :mm 1min
limit 0.1- 9999.9 mL 0.1mL
Press [RATED.LIMITmL] key, to set the expected infusion time.
Press[]/[]/[<]/[>] key to adjust the time.
Press [RATED.LIMITmL] key to set the D.Limit, using []/[]/[<]/[>]keys to
adjust the limit value.
After the setting is finished, press [RATED.LIMITmL] key will show the total
volume interface. If need clear the total value, press the [C] key for one second.
BrandMC Size50mL
Rate100.0mL/h Occ II
CAUTION:
Please confirm the used syringe brand and size,the flow rate and the occlusion level
carefully.
Press the [START/STOP] key again to start the infusion.
After the infusion starts, the LCD display interface is as following:
50
II
mL/h
Press the [START/STOP] key during the infusion, the infusion will stop.Press the
[START/STOP] key again will continue to infuse. If need modify the time-mode
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Operating Instructions
infusion parameter, press [RATED.LIMITmL]key to modify the time and limit. If
need modify other setting, press [SET] key.
50
50
II
mL/h
CAUTION:
If the flow rate is out of range, pressing[START/STOP] cannot start the infusion.
If reload the different size syringe, will enter the setting menu and the D.LIMIT and
flow rate will be cleared.
Speed Time
Weight
25 / 54
Operating Instructions
After the setting is finished, press [RATED.LIMITmL] key will show the total
volume interface. If need clear the total value, press the [C] key for one second.
The flow rate can be calculated automatically. If the flow rate is out of range, will
display -----,and cannot start infusion.
Press the [START/STOP] key to confirm the infusion parameter.
BrandMC Size50mL
Rate100.0mL/h Occ II
CAUTION:
Please confirm the used syringe brand and size,the flow rate and the occlusion level
carefully.
Press the [START/STOP] key again to start the infusion.
After the infusion starts, the LCD display interface is as following:
50
II
mL/h
Press the [START/STOP] key during the infusion, the infusion will stop.Press the
[START/STOP] key again will continue to infuse. If need modify the weight-mode
infusion parameter, press [RATED.LIMITmL] to modify the parameter. If need
modify other setting, press [SET] key.
CAUTION:
If the flow rate is out of range, press [START/STOP] cannot start the infusion.
If reload the different size syringe, enter the setting menu, the D.LIMIT and flow rate
will be cleared.
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Setting the Syringe Pump
7 Setting the Syringe Pump
CAUTION:
After a syringe pump is powered off, all parameter settings will be automatically
saved for nearly 20 years.
Parts of parameters will not be saved if the device is forced to shutdown.
Occ. LevII
NOTE:
The specified Occlusion Level will be automatically retained in the memory when you
turn the pump off.
After the setting is complete, press [SET]key to save the setting and return to the
main menu.
CAUTION:
When you infuse viscous solution with the Occlusion Level I, occlusion alarm tends to
be issued.Carefully watch the [OCCLUSION LEVEL] indicator, and change the
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Setting the Syringe Pump
occlusion level if necessary.
When you operate the pump with the Occlusion Level III, the in-line pressure builds
up substantially until Occlusion alarm is issued. Always make sure that the IV line is
securely connected to the syringe.
7.2.1Selecting a band
Press [SET] and shift the arrow to the Bra.Set item, then press
[RATED.LIMITmL] key .
Password***0
28 / 54
Setting the Syringe Pump
7.2.2Customizing a brand
CAUTION:
If you want to add syringes of other brands, we strongly recommend that you contact
your syringe suppliers to dispatch professionals to perform setting and testing so as
to ensure the syringe accuracy.
If you want to set the syringe by yourself, contact the local distributor for the setting
method.
Password***0
Vox Set2
29 / 54
Setting the Syringe Pump
If setting alarm to extreme values that can render the alarm system useless. Check
the alarm limited according to clinical condition.
Press [] / [] to select the history number of the event you want to see.
Press[RATED.LIMITmL] key to view the event time
Press[RATED.LIMITmL] key again to view more detailed information.
Press [], [] to page down or page up.
Press [SET] back to last interface .
Press [SET] again to return to main menu.
CAUTION:
The history records could be saved when power is cut.
300 history records could be saved. When the record number reaches the storage
limit, the oldest record will be replaced by the new one.
Alarm system cant be poweredoff separately by operator unless the pump is
powered off.The time of powering off is captured in the history records.
7.5 Maintenance
Press [SET] and shift to the Maintena, press[RATED.LIMITmL] key.
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Setting the Syringe Pump
Password***0
2000-01-01 00:00
LanguageENGLISH
31 / 54
Setting the Syringe Pump
New Pwd***0
Confirm Pwd****
Press [SET] in turn to return to main menu.
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Setting the Syringe Pump
The approx. remaining power in the internal battery is displayed by [battery] icon.
During battery operationbattery discharged is shown by a decreasing number of
active indicators. For details, see !-2.
CAUTION:
Regardless of the power on/offthe [Battery] indicator lights on if AC or DC power is
connected and indicators that the battery is being recharged.
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Setting the Syringe Pump
Use AC power to charge the battery. When recharged by an external 12 V DC power
supply, the battery cannot be fully charged (50% at most).
Low battery alarm indicators lights on and the buzzer sounds when the capacity of
the internal battery becomes nearly empty. Press [SILENCE] to silence the alarm and
connect the pump to the AC or DC mains.
When you give an injection using the syringe pump powered by its internal battery:
If a low-battery warning occurs, press [SILENCE] to silence the alarm for two
minutes, after which the alarm will repeat.
If a critical battery alarm occurs, the alarm cannot be silenced and the injection
cannot be started.
The syringe pump automatically shuts down three minutes before the battery is
drained.
The actual battery duration may be different from the duration shown in table 7-6
affected by the ambient temperatureflow rateexternal communicationetc.
If the battery is deterioratingthe actual battery duration may be shorter. Periodically
check the battery.
CAUTION:
Do not operate the syringe pump in the healthcare monitoring system.
When connecting the syringe pump to an external medical monitortake precautions
to ensure safety such as by checking the specifications with the monitor manufacturer
and the communication cable manufacturer.
Before connecting a medical monitorensure system safety by first checking for its
compliance with IEC 600601-1-1.
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Setting the Syringe Pump
When the multi-function socket is not in use, put the sealing cover back into the
socket.
Only the accessory or devices supplied or specified by manufacturer allowed to be
connected with the pump. Otherwise it may cause the pump not work normally or
other unpredictable hazards.
Syringe pump cannot be operated through the external communication.
CAUTION:
When connecting the syringe pump to an external medical monitortake precautions
to ensure safety such as by checking the specifications with the monitor manufacturer
and the communication cable manufacturer.
Before connecting a medical monitorensure system safety by first checking for its
compliance with IEC 600601-1-1.
When the multi-function socket is not in use, put the sealing cover back into the
socket.
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Troubleshooting
8 Troubleshooting
8.1 Alarm
The syringe pump provides users with a variety of status information about itself and
its injection process. If any abnormality is detected, the syringe 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.
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.
For audio and visual expressions of alarms at three levels, see Table 8-1. The alarm
volume ranges from 45 dB to 85 dB.
Table 8-1 Alarm severity and the audio and visual expressions of each level
Low-level alarm Give out three beeps at intervals The yellow indicator keeps on.
of 25 seconds.
Mid-level alarm Give out three beeps at intervals The yellow indicator flashing.
of 25 seconds.
High-level alarm Give out a series of beeps at The red indicator flashing.
intervals of 15 seconds.
When an alarm occurs, press [SILENCE] to silence the alarm. But the buzzer beeps
again if you do not eliminate the high-level alarm within 2 minutes.
CAUTION:
The setting of the alarm will be saved when the power is cut. When the pump restarts
from a power failure situation, the alarm setting will be reloaded to the system and
remains the same as it was before the power failure.
WARNING:
There will be a potential risk if the same or similar devices are using different alarm
setting in any specialized region.
36 / 54
Troubleshooting
8.2 Faults and Troubleshooting
Table 8-2 Alarm symptom, alarm level, fault cause, and troubleshooting
37 / 54
Troubleshooting
Alarm Symptoms Alarm level Causes Troubleshooting
Syn Loose High-level Syringe disengagement Press [START/STOP]to
from slit during infusion. clear the alarm. Check if the
syringe pump clamp or
syringe is installed correctly.
Limit Less Than Low-level The limit value is less than Clear the limit or total value
Total the total value
Forget Low-level Forget to operate the Press any key to clear the
alarm (no key operation is alarm.
made two minutes after
the syringe is installed).
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Maintenance
9 Maintenance
WARNING:
39 / 54
Maintenance
9.2.2Check the Power Cable
Check the appearance of the power cable. If the appearance is damaged and the
plug and the socket are in poor contact, contact manufacturer or manufacturers
representativesfor replacement in time.
If you connect the syringe pump to the AC/DC power and there is no indication of
powering on, contact manufacturer or manufacturers representatives for
maintenance in time.
9.2.4Alarms
Syn Loose
1.Pull of the syringe clamp during infusion, alarm information will be visible on the
display and audible.
2.Press of the clutch during infusion, alarm information will be visible on the display
and audible.
Occlusion
Checking condition:
40 / 54
Maintenance
If the time from the start of the infusing to end of operation is 4 hours or morethe
battery condition is good.
If the time from the start of the infusing to end of operation is 1 to 2 hoursthe
battery condition is reaching its service life.
If the time from the start of the infusing to end of operation is less than 1 hourthe
battery has reached its service life. Replace the battery. You are advised to
contact manufacturer or manufacturers representative to replace the battery.
When the battery lever check is complete, recharge the battery for next use.
CAUTION:
Remove the battery if the infusion pump is not likely to be used for some time.
WARNING:
The batterys replacement must be done by specialist who has been trained to finish
such operation. Otherwise there will be a risk of danger.
Please strictly follow the instruction to replace the battery, and the battery should be
provided by the manufacturer. Otherwise there will be a risk of danger.
Do not disassemble, short circuit or throw the battery into fire in case of the danger
caused by linkage or explosion.
Please follow the local low to dispose the old battery.
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Maintenance
9.3 Maintenance
If any troubleexplain the situation to the manufacturer or manufacturers
representative and request for repair.
Never disassemble ,modify or try to repair the syringe pump. Doing so may cause a
serious failure. The manufacturer and the distributor shall not be responsible for any
syringe pump that has been disassembledmodified or used for any purpose other
than that for which it is intended.
If the syringe pump is dropped or subjected to impactremove it from service even if
it doesnt appear damaged externally. Request the manufacturer or manufacturers
representative to inspect it for a possible internal problem.
CAUTION:
Serviceman could request for the related service manual from the manufacturer if
needed.
WARNING:
The accessories replacement must be done by specialist who has been trained to
finish such operation. Otherwise there will be a risk of danger.
Parts of the Pump are not serviced or maintained while in use with the patient
9.4 Storage
Avoid water spills.
Never store in a hot and humid place.
Store the pump out of excessive vibrationdustand corrosive gas.
Store the pump out of direct sunlight and ultraviolet ray as discoloration may result.
9.5 Transportation
The syringe pump can be transported by common vehicles and shall be protected
from being clashed, shook, or wetted by rain and snow. Transportation method shall be in
accordance with the order contract specifications.
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Flow Rate Characteristics
10 Flow Rate 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.
The infusion accuracy does not reflect the clinical standards, for example, patients'
age and weight and medicine taken.
The experiment data only represents the measurement data in the lab.
The max accuracy difference is 40% under the condition of single failure.
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Flow Rate Characteristics
Start-up curves of MC(50ml) 5ml/h Start-up curves of MC(50ml) 1ml/h
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Flow Rate Characteristics
10.2 Occlusion Characteristics
The occlusion characteristics are reflected by the longest delay time to start an alarm
and performance of pill amount.
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.).
Occlusion test conditions:
Temperature: 21;
Relative humidity: 65%;
Syringe type:MC50ml; 1 set
Length of the infusion tube: 1m
Table8-1The occlusion level, alarm delay time and pill amount under the rate of 5mL/h
Table1-2 The occlusion level and alarm delay time under the rate of 1mL/h
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Flow Rate Characteristics
Table 1-3 The occlusion level and alarm delay time under the rate of 0.1mL/h
I 300100 17:48:11
0.1mL/h
III 800200 36:13:58
CAUTION:
Unit conversion list
Description Unit Unit conversion
kPa 1kPa=7.5mmHg
Pressure psi 1psi=51.724mmHg
bar 1bar=750mmHg
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Appendix A
Appendix A Electronmagnetic Compatibility (EMC)
TheSYS-3010 syringe pump complies to EMC standard IEC 60601-1-2.
Guidance and manufacturers declaration electromagnetic emissions
The [SYS-3010] is intended for use in the electromagnetic environment specified below.
The customer or the user of the [SYS-3010] should assure that it is used in such an
environment.
Emission test Compliance Electromagnetic environment guidance
47 / 54
Appendix A
Guidance and manufacturers declaration electromagnetic immunity
The [SYS-3010] is intended for use in the electromagnetic environment specified below. The
customer or the user of the [SYS-3010] should assure that it is used in such an environment.
IMMUNITYtest IEC60601test level Compliance level Electromagnetic environment
guidance
Electrostatic 8 kV contact 8 kV contact Floors should be wood,
discharge discharge discharge concrete or ceramic tile. If
ESD 15 kV air discharge 15 kV air floors are covered with
IEC 61000-4-2 discharge synthetic material, the relative
humidity should be at least
30 %.
Electrical fast 2 kV power cable 2 kV power cable Mains power quality should
transient 1 kV I/O cable be that of a typical
EFT commercial or hospital
IEC61000-4-4 environment.
Surge 1 kV difference mode 1 kV difference
IEC 61000-4-5 2 kV common mode mode
2 kV common
mode
The voltage 5% UTdropping 5% UTdropping Mains power quality should
dropping, short 95% UT0.5 period 95% UT0.5 be that of a typical
interruption and period commercial or hospital
voltage change 40% UT dropping environment. If the user of the
IEC 61000-4-11 60% UT5 period 40% UT dropping [SYS-3010] requires
60% UT5 period continued operation during
70% UTdropping 30% power mains interruptions, it
UT25 period 70% UTdropping is recommended that the
30% UT25 period [SYS-3010] be powered
5% UTdropping from an uninterruptible power
95% UT5seconds 5% UTdropping supply or a battery..
95% UT
5seconds
Power 3 A/m 3 A/m Power frequency magnetic
48 / 54
Appendix A
frequency fields should be at levels
magnetic fields characteristic of a typical
50/60Hz location in a typical
IEC 61000-4-8 commercial or hospital
environment
NOTE UTis the a.c. mains voltage prior to application of the test level.
49 / 54
Appendix A
Guidance and manufacturers declaration electromagnetic immunity
The [SYS-3010] is intended for use in the electromagnetic environment specified below. The
customer or the user of the[SYS-3010] should assure that it is used in such an environment.
Immunity IEC 60601 Compliance
Electromagnetic environment guidance
Test test level level
Conducted 3 Vrms 3 Vrms Portable and mobile RF communications
RF 150k equipment should be used no closer to any part
IEC61000-4-6 80MHz of the [SYS-3010], including cables, than the
Radiated RF 3V/m 3 V/m recommended separation distance calculated
IEC61000-4-3 80M from the equation applicable to the frequency of
2.5GHz the transmitter.
Recommended separation distance:
d 1.2 P
d 1.2 P 80M800MHz
d 2.3 P 800M2.5GHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
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Appendix A
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
dueto fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the [SYS-3010] is used exceeds the applicable
RF compliance level above, the [SYS-3010] 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-3010] .
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
51 / 54
Appendix A
Recommended separation distances between portable and mobile RF communications equipment
and the [SYS-3010]
The[SYS-3010] is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the[SYS-3010] can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the[SYS-3010] as recommended below,
according to the maximum output power of the communications equipment.
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distancedin metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where Pis the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply inall situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
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Appendix B
Appendix B The Default Factory Settings
This chapter lists some default factory settings of syringe pump. Users can not modify
the default factory settings, but if necessary, they can recover the syringe pump to the
default factory settings state.
Parameters
System time
Date 2000-1-1
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Appendix C
Appendix CToxic and Hazardous Substances or Elements
Polybromi polybrominat
Plumbum Mercury Cadmium Chromium nated ed diphenyl
Description
Pb Hg Cd VI Cr(VI) biphenyls ethers
PBB PBDE
pump shell
key and
cover
label
display
hardware
connection
wire
PCBA
packing
material
battery
accessory
remark:
shows that the content of this toxic and harmful substance in all homogeneous
materials are under the regulated limitation requirement of SJ/T11363-2006.
shows that he content of this toxic and harmful substance in one homogeneous
materials is over the regulated limitation requirement of SJ/T11363-2006.
54 / 54
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Registration address: 12th Floor, Baiwang Research Building, No.5158 Shahe West Road,
Xili, Nanshan District, Shenzhen, P.R.China
Production address: 1-4 Floor,11th Building,Nangang Industrial Park, Songbai Road, Xili,
Nanshan District, Shenzhen, P.R.China
After-sales service address: 12th Floor, Baiwang Research Building, No.5158 Shahe
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 2015Medcaptain Medical Technology Co., Ltd. (V1.1)