Triumph SP12 User manual

User Manual
Triumph SP12 Syringe Pump

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Contents
1. Safety.……………………………………………2-3
2. Specifications……………………………………...4-6
3. Appearance………………………………………7-11
4. Installation……………………………………...12-13
5. Basic Operation………………………………........14
6. Infusion Operation……………………………..15-21
7. System Settings…………………………………22-24
8. Alarms/Troubleshooting………………… .…25-26
9. Maintenance/Repair/Warranty………………..27-30

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1. Safety Instructions
Warnings
Before using, please check the equipment. Connect the power cord and accessories to ensure that it
works normally and safely. If there’s anything abnormal, immediately stop using the equipment and
contact Triumph Medical Service Department. Additionally, the adhesion or intrusion of fluid/drug
may possibly cause the equipment fault and malfunction. Therefore, please clean the equipment after
use, and store it correctly.
This equipment must be operated by trained professional medical care personnel.
This equipment is not applicable to blood transfusion.
It is not allowed to put and use the equipment in the environment with anesthetic and other
inflammable or explosive articles to avoid fire or explosion.
It is not allowed to store or use the equipment in the environment with active chemical gas (including
gas for disinfecting) and moist environment. This may influence the inside components of the
syringe pump and may possibly cause performance drop or damage of the inside components.
The operator shall guarantee that the inputted infusion parameters of this equipment are the same as
the medical advice before starting infusion.
Please do not only depend on alarm system during use, please periodically check the equipment to
avoid accident.
If the syringe extension tube is twisted, filter or needle is obstructed, or there is blood in the needle
which may obstruct the syringe then the pressure in the tube will rise. When removing such occlusion,
it may possibly cause “bolus injection” (temporary excess infusion) to the patient. The correct method
is to tightly hold or clamp the extension tube near the puncturing position, then loosen the tube, solve
the reason of occlusion, and restart infusion. If infusion is restarted when the occlusion reason exists,
then this may cause occlusion alarm persistently. The pressure in the syringe tube may keep rising,
and may break or cut off the tube, or hurt the patient.
This equipment has the occlusion detection function for detecting and alarming when the syringe
needle deviates the position in the vein or the needle is not correctly punctured in the vein. However, it
only alarms when the occlusion pressure has reached certain numerical values. The puncturing part
may possibly have become reddish, swelling or bleeding. It is possible that the device doesn’t alarm
for a long period if the actual occlusion pressure is lower than the alarm threshold value, therefore,
please periodically check the puncturing site. If there’s any abnormal phenomenon for the puncturing
site, please take suitable measures

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Only sterile hypodermic syringes for single use and other medical components that meet the local laws
and regulations and the requirements covered in and this User Manual can be used. It is suggested to
adopt the syringe with same brand as defaulted in this equipment. Accuracy cannot be guaranteed if an
unsuitable syringe line is used. Please use the syringe and the extension tube with a luer lock.
It is not allowed to disassemble or refit this equipment or use it for other purposes except normal
infusion.
No one is allowed to repair this equipment except Triumph Medical Services.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with protecti
-ve earth

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2. Specifications
Safety Classification
Electric protection
Type Class I
Electric protection
Level Defibrillation proof type CF applied Part
Ingress Protection IP34 (Prevent solid objects larger than 2.5mm in diameter and water intrusion
from splashing in all directions)
Working mode Continuous
Classification Portable equipment, non-portable syringe pump
Specification Parameters
Compatible Syringes 3ml (most major brands), 5/6ml, 10/12ml, 20ml, 30/35ml, 60ml
System Accuracy
≥ 1ml/h, ±3%
＜ 1ml/h, ±5%
Infusion Rate
Syringe size 3ml: (0.1-100) ml/h
Syringe size 5/6ml: (0.1-150) ml/h
Syringe size 10/12ml: (0.1-300) ml/h
Syringe size 20ml: (0.1-600) ml/h
Syringe size 30/35ml: (0.1-900) ml/h
Syringe size 60ml: (0.1-1500)ml/h
Bolus Rate
Syringe size 3ml: (0.1-100) ml/h
Syringe size 5/6ml: (0.1-150) ml/h
Syringe size 10/12ml: (0.1-300) ml/h
Syringe size 20ml: (0.1-600) ml/h
Syringe size 30/35ml: (0.1-900) ml/h
Syringe size 60ml: (0.1-1500)ml/h
Bolus preset value Min: 0.1ml Max: max rate of accordingly loaded syringe size
KVO Rate 0-5.00ml/h
Micro mode
setting range
Syringe size 3ml: (100-100) ml/h
Syringe size 5/6ml: (100-150) ml/h
Syringe size 10/12ml:(100- 300) ml/h
Syringe size 20ml: (100-600) ml/h
Syringe size 30/35ml: (100-900) ml/h
Syringe size 60ml: (100-1500) ml/h
Minimum flow rate
increment 0.01ml/h
VTBI 0-9999.99ml, minimum step is 0.01ml
Total Volume
Infused 0-9999.99ml, minimum step is 0.01ml

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Time Range 1min-99hrs59min
Fuse Type slow fuse 2A 250V
Dimensions 242.5(W)*111(D)*126.5(H) mm
Weight 1.7kg
Power Supply
AC power supply 100-240V 50/60Hz
Input power 50VA
DC power supply DC 12V
Battery
Specifications
Specification: 7.4V 2500mAh
Charging time: 5h. (under OFF status)
Working time: over 9h. (after completely charging the new battery, when the
environment temperature is 25℃and flow rate is 5ml/h, the constantly working
time)
Alarm
Alarm signal sound
pressure level
When the sound is set at lowest level, alarm signal sound pressure level
≥50dB(A)
When the sound is set at highest level, alarm signal sound pressure level
≤80dB(A)
Alarm information
VTBI near end, Syringe near empty, VTBI infused, Syringe empty,
Pressure high, Battery nearly empty, Battery empty, no battery inserted, Battery
in use, Check syringe, Reminder alarm, Standby time expired, KVO finished,
Drug limit exceeded, Maintenance Reminder
Environment
Non AP/APG type
equipment
Do not use it in the environment with inflammable anesthetic gas mixed with air,
and inflammable anesthetic gas mixed with oxygen or nitrous oxide
Operating
(1) temperature: 5-40℃
(2) humidity: 15-95%, non-condensable
(3) atmospheric pressure: 57-106kPa
Transport & Storage
(1) temperature: -20-60℃
(2) humidity: 10-95%, non-condensable
(3) atmospheric pressure: 50-106kPa

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Safety Standard
Main Safety
Standards
IEC 60601-1:2005+A1:2012
Medical Electrical Equipment, Part 1: General Requirements for basic safety and
essential performance
IEC60601-2-24:2012
Medical electrical equipment – Part 2-24: Particular requirements for the safety
of syringe pumps and controllers
IEC60601-1-8：2006
+A1：2012
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 electrica
l systems
EN60601-1-2:2007+AC:2010
Medical Electrical Equipment - Part1-2: General requirements for basic safety
and essential performance-Collateral standard:Electromagnetic compatibility-Req
uirements and tests

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3. Appearance
FRONT VIEW
①Handle
Control syringe pump push-pull sliding box and clip.
②Slider box
③Pressure sensor
Detect the pressure of the syringe
④Syringe clip
Clamp the syringe plunger
⑤Lead-screw
⑥Syringe fixture lever
Pull forward then turn right, install the syringe into the slot.
⑦Tube line Clamp
Keep the extension line in line and neat

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OPERATION PANEL
①Touch Screen
②【Power】
Pump power switch, press and hold for 3 seconds to turn pump on, pump power off, and
standby selection button.
③AC indicator light
When connecting with AC power supply, AC indicator lights on.
④Alarm indicator light
While pump alarms, indicator light flashes, different levels indicate different frequency and
color, more information please refer to section 8 and 9.
⑤Running lights
⑥【Start/stop】
⑦【Bolus/Purge】
⑧【Home】
Enter system home page.

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Display Screen
The display screen interface layout composes of title bar and typical interface.
Title Bar
Title bar displays real-time information and is not touchable, the left upper corner displays the name of
current editing parameter.
Title Bar Icon
Icon Paraphrase Description
Syringe apparatus
indication icon Syringe apparatus indication icon
Lock screen
indication icon Unlock state icon is
WIFI indication icon Indicate WIFI connection state.
Battery charging
indication icon Display the current battery charging state
Battery status
indication icon
The percentage numerical value at the left side of the icon displays
the remained battery.
Since the remained battery may change, it may show the following
states:
Typical Interface
During pre-infusion and infusion, the typical interface will display the following: main interface, working
interface, alarm interface, prompt interface, control panel, parameters setting, input method, standby
interface etc.

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Typical Interface Icon Paraphrase
Icon Paraphrase Description
Start Click this icon, start infusion
Stop Click this icon, infusion stop
Bolus/Purge
1. During infusion, it is a『Bolus』function, click it to start bolus infusion
2. Before starting infusion, it is a『Purge』function, click it to exhaust air
from the syringe
Home Click this icon, return to the main interface
Input Method Interface
The input method interface composes of the title bar, input box, and editing box.
1) Title bar: displays the name of current editing parameter.
2) Input box: real-time display of the input content.
3) Editing box: Is composed of the main button area and function button area.
The main button area composes of numerical values, letters, and icons.
The function button area composes of the clear button, cancel button, 『 』, 『 』,『 』and『Shift』.
Icon Paraphrase Description
Backspace button Click it to backspace delete
Shift Shift button Click it to switch the capital and lowercase English letters
Cancel button Click it to cancel editing and exit
OK button Click it to save editing and exit

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Rear View
①USB Port
Port only for software upgrade
②DC Input Port
External 12V DC power supply
③Handle
④A/C Adapter Port
External 100-240V 50/60Hz AC power supply
⑤Pole Clamp
Using for fixing the equipment to an infusion stand
⑥Loudspeaker
⑦IrDA
Used for communicating with infusion docking station (Optional)
⑧Latch for stackable function
⑨Slider box

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4. Installation
Unpacking and Checking
1) Please check the appearance before unpacking. If broken, please contact the transportation company
or Triumph Medical as soon as possible.
2) Please carefully open the package to avoid damaging the equipment and relevant accessories.
3) After unpacking, please check the objects according to the packaging list. If there are insufficient or
damaged accessories, please contact Triumph Medical as soon as possible.
4) Please keep relevant accessories and warranty card.
5) Please keep the packing case and packing materials for future transportation or storage.
Warning: Please put the packing materials out of reach of children. Please obey local laws and
regulations or the hospital waste treatment system to handle the packing materials.
Installation
Warning:
This equipment shall be installed by the designated technicians.
All devices that connect with this equipment must pass the designated IEC standards (for example:
IEC60950 information technology equipment safety and IEC60601-1 medical electric device safety)
certification. All devices must be connected according to the valid version of IEC60601-1-1 system.
The technician who takes charge of connecting to additional devices with the equipment interface is
responsible for meeting the IEC60601-1-1 standard. Please contact Triumph Medical if you have any
question.
When connecting this equipment with other electrical devices in special circumstances and the
combination can’t be confirmed dangerous or not, please contact Triumph Medical or an electrical
expert to ensure safety.
This equipment must be used and stored in the environment regulated by the terms of this manual.

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Install the syringe Pump Pole Clamp
(1) Install pole clamp/cage mount using provide
hex wrench and screw.
(2) If using as a cage mount then leave rotary
knob off of pole clamp and install the mount
vertically as shown below leaving the “split” side
of pole clamp at the top. Ready to mount to cage.
If using as a pole clamp please proceed to step 3.
(3) If mounting on pole rotate the pole clamp
screw(knob) and unscrew to leave space. Lock
the Pole Clamp on the infusion stand, adjust the
position of the infusion pump, tighten the pole
clamp to fix the infusion pump on the infusion
stand (shown in drawing to the right). Hold the
infusion pump when tightening and loosening the
fixing clamp.
(4) The pole clamp supports the vertical pole at
default state. To adjust the pole clamp direction,
please remove the bolt from the pole clamp
screwdriver, take out the pole clamp and adjust the
direction, then tighten the bolt.

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5.Basic Operation
Operation Flow
1. ¤ Mount the syringe pump on the IV Pole or Cage
2. ¤ Power on: press two seconds
3. ¤Install syringe
4. ¤ Confirm syringe brand and size: or select syringe brand
5. ¤Remove air bubble in the line
6. ¤Select infusion mode: select infusion modes according to requirement
7. ¤Set infusion Parameters: set infusion parameters according to requirement
8. ¤ Connect infusion line with patient
9. Confirm all Settings and Parameters
10. ¤ Start infusion: press
11. ¤ Infusion finish
12. ¤ Remove syringe
13. ¤ Power off or Standby

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6. Infusion Operation
Equipment Installation
Mount the device on a pole or level surface, connect the power cord and check the AC indicator
lights. Battery will start to charge once AC power is connected.
Starting and Self-test
1) Press two seconds
2) After powering on, the system will automatically check the motor, sensor, battery, memorizer,
CPU communication, and alarm indicator.
3) After passing the self-test, pump enters into rate mode interface.
Warning: ●If self-test failed, pump cannot operate properly and cannot be used for patient
infusion, please contact Triumph Medical.
Install Syringe
(1) Hold the clutch and pull the slider to the right side.
(2) Pull the syringe fixture lever, turn 90° right or left.
(3) Insert the syringe flange fully into slot (flange holder), turn syringe fixture lever 90° to spring
back to tighten the syringe.
(4) Hold the clutch and push left, release after it touches the plunger firmly.
(5) Put the extension line of syringe into the extension line hook.
(6) Confirm Syringe Brand/Size or if necessary Click『Setting』→『Commonly used Syringe
brand』to choose syringe brand.
Warning:
Recommend to use a syringe brand preinstalled in this syringe pump.
Make sure the syringe brand and size in the display screen is the same as the one in use.
Caution：
●Check to ensure no air bubbles in syringe.
●Make sure syringe is correctly installed. Otherwise accuracy will not assured and may do
harm to patient due to no infusion or over infusion due to a siphon.

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Set Infusion Parameters
Remove Air bubble
Under the parameters setting interface, Press 【Bolus】button and hold on, or touch the purge
icon on the product panel, eliminate the air bubble in the line.
The purge total volume is not calculated in the Total Volume Infused.
Cautions:
●Before purging air, double check to confirm the infusion line is not connected to the patient.
●Purge rate is the max rate of the syringe size, when purge volume ≥5ml, purge will
automatically stop.
Start Infusion
Connect IV tube to patient, confirm infusion parameters, Press【Start】button , click 『yes』
in the pop-up prompt interface, start infusion.
Change the Rate During Infusion
Under the running interface, click the rate number on the touch screen or【Stop】 , and then
enter parameters setting interface. Reset target infusion rate.
Note: ●Only the rate mode, time mode and Body weight mode support online rate
modification function during infusion without pressing【Stop】 .

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Bolus Application
In operation, Bolus functions have two operation modes: Manual bolus and Automatic bolus.
(1) Manual bolus: press and hold the【Bolus】button on the product panel. Pump will work
at the max flow rate of current syringe size, or set max bolus rate under setting interface. Release
the button, pump will go back to the previous set infusion rate.
(2) Automatic bolus: Under the running interface, click『Bolus』on touch screen. Set two
parameters among bolus infusion volume, rate and time, click『Start』. It will beep at every 1ml
infused. After bolus infusion is finished, the equipment goes back to the previous infusion rate.
Infusion Completion
When remaining infusion time is near preset volume to be infused completion time, pump will
alarm (This alarm can be adjusted or turned off in settings). If you ignore it, the system will keep
alarming until VTBI is completed.
After VTBI completed, it activates VTBI infused alarm. If KVO function is ON, the equipment
automatically starts KVO function. Click 『OK』in the alarm interface to stop KVO and
eliminate alarm.
The default working time of the KVO system is 30 minutes. After reaching that time, it will
activate a KVO completion alarm and stop infusion.
Stop Infusion
During infusion or after infusion, click , infusion stop. It will return to the parameter setting
interface display.
Remove the syringe
Disconnect the extension line from the patient, then remove the syringe.

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Power OFF or Standby
Method 1: hold the 【Power】Button till the screen is OFF.
Method 2: press the 【Power】Button to enter into OFF interface.
⑴Turn off the equipment: click 『Power off』icon, the equipment is turned OFF.
⑵Standby: click 『Standby』icon to enter into standby time setting interface and set the standby
time. Under standby state, the screen brightness will be at the lowest setting. After standby,
the screen brightness will be recovered.
⑶Cancel: click『Cancel』, return to the interface before OFF setting.
Note: ●The equipment has a standby function only under the non-working state.