Triumph IP12 User manual

User Manual
Triumph IP12 Infusion Pump

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Contents
1. Safety.……………..………………………………3-4
2. Specifications……………………………………...5-6
3. Appearance………………………………………7-11
4. Installation……………………………………...12-13
5. Basic Operation………………………………........14
6. Infusion Operation……………………………..15-19
7. Settings………………………………………….20-25
8. Alarms/Troubleshooting…………………….…26-27
9. Maintenance/Repair/Warranty…………..…..28-31

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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 working and contact
Triumph Medical’s service department. Additionally, the adhesion or intrusion of fluid/drug may
possibly cause the equipment to 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 gasses
(including gasses for disinfecting) and moist environment since it may influence the inside
components of the infusion 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 correctly install the infusion line according to the infusion indication direction of this
equipment, ensure that the infusion tube is placed smoothly and straightly cross the creep device.
Otherwise, it may possibly suck blood from the patient or fail to reach the expected performance.
Please do not only depend on the alarm system during use. Periodically check the equipment to
avoid any accidents.
Tightly fix the equipment on the infusion stand/pole and ensure the stability of the infusion stand/pole.
Be careful when moving the infusion stand and this equipment to avoid the equipment dropping and
infusion stand/pole falling or knocking the surrounding objects.
If the infusion tube is twisted, or the filter or needle are obstructed, or blood is in the needle which
may obstruct the infusion, the pressure in the infusion 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 infusion tube near the puncturing position, then open the door to drop the
pressure in the infusion tube. Then loosen the infusion tube, solve the reason of occlusion, and restart
infusion. If infusion is restarted when the occlusion reason exists, then it may cause occlusion alarm
persistently, and the pressure in the infusion tube may keep rising, and may break or cut off the
infusion tube, or hurt the patient.
This equipment injects fluid/drug through extruding the infusion tube, but it can’t detect the leakage if

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the infusion line is cut off or broken. Therefore, please periodically check the equipment it to avoid
above fault during the working period.
During infusion, periodically check the dripping state of the fluid and the fluid/drug in the intravenous
infusion bag/container, so as to ensure it is working correctly during infusion. This equipment doesn’t
directly measure the quantity of infusion fluid; therefore, it is possible that this equipment can’t detect
the free infusion flow under abnormal conditions. Even if the drop sensor is adopted, it is possible that
this equipment can’t detect the free infusion flow which is less than the specific value for the demands
of tolerance.
This equipment has the occlusion detection function for detecting and alarming when the infusion
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 value. As a result, the
puncturing part may possibly have become reddish, swelling or bleeding. Additionally, 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 part. If there’s any abnormal
phenomenon for the puncturing part, please timely take suitable measures, such as puncturing again.
Only the infusion line, infusion needle and other medical components that meet the local laws and
regulations and the requirements covered in this User Manual can be adopted. It is suggested to use
the infusion lines with same brand as preinstalled in this equipment. Infusion accuracy cannot be
guaranteed if a infusion line brand that is not preinstalled is used. The drop sensor is based on infrared
sensor technology, if the drip sensor function is turned on, then the light-proof pipeline is not
applicable.
It is not allowed to disassemble, refit, or use this equipment for other purposes except normal infusion.
No one is allowed to repair this equipment except Triumph Medical Services LLC.
To avoid risk of electric shock,the equipment must only be connected to a supply mains with protectiv
e earth.

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2. Product Specification
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 infusion pump
Specification Parameters
Infusion line
specification 10-60 drops
System Accuracy ±5%
Drip Infusion Rate
Accuracy ±5% or ±1drops/min
Infusion Rate 0.10-1500ml/h
Drip mode range 1~500drops/min
Bolus Rate 0.1-1500ml/h
Bolus preset 0.1-50ml
KVO Rate 0.1-5.00ml/h
Micro mode
setting range 100-1500ml/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
Time Range 1min-99hrs59min
Fuse Type slow fuse 2A 250V
Dimensions 199(W)*111(D)*126.5(H) mm
Weight 1.4kg
Power Supply
AC power supply 100-240V 50/60Hz
Input power 50VA

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DC power supply DC 12V
Battery
Specifications
Specification: 7.4V 2500mAh
Charging time: 5h.(under OFF status)
Working time: over 8h.(after completely charging the new battery, when the
environment temperature is 25℃and flow rate is 25ml/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, VTBI infused, Pressure high,
Battery nearly empty, Battery empty, No battery inserted, No power supply, Remi
nder alarm, Standby time expired, KVO finished, Drop sensor connection, Drop
error, Air bubble, Door Open, Confirm Drops Are Flowing in Drip Chamber,
Drug limit exceeded, Maintenance Alarm
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: 20-90%, non-condensable
(3) atmospheric pressure: 86-106kPa
Transport & Storage
(1) temperature: -20-60℃
(2) humidity: 10-95%, non-condensable
(3) atmospheric pressure: 50-106kPa
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 o
f infusion pumps and controllers
IEC60601-1-8：2006+A1：2012
Medical electrical equipment –Part 1-8: General requirements for basic safety an
d essential performance –Collateral Standard: General requirements, tests and gui
dance for alarm systems in medical electrical equipment and medical electrical sy
stems
EN60601-1-2:2007+AC:2010
Medical Electrical Equipment - Part1-2: General requirements for basic safety an
d essential performance-Collateral standard:Electromagnetic compatibility-Requi
rements and tests

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3. Appearance
Front View
①Tubing guide
② Pump door
④⑥⑩ Pressure Plate
③Pressure sensor-UPSTREAM (if applicable)
⑦Pump tablets
⑨ Pressure sensor-DOWNSTREAM
⑤⑧Air–in-line sensor
⑪Anti-free flow clamp

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Operation Panel
①Touch Screen
②【Power】
Pump power switch, press and hold for 3 seconds, pump power off. Standby selection button.
③AC indicator light
When connecting with AC power supply, AC indicator lights on.
④Alarm indicator
While pump alarms, indicator light glitter, different level different frequency and color, more
information please refer to Chapter 10.1
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
The Title bar displays real-time information and is not touchable, the left upper corner displays the name of
current editing parameter.
Icon Paraphrase Description
Infusion line
indication icon
Infusion line indication icon
Lock screen
indication icon Unlock state icon is
WIFI indication icon Indicates WIFI connection state.
Battery charging
indication icon
Displays the current battery charging state
Battery status
indication icon
The percentage numerical value at the left side of the icon displays
the remaining battery.
Since the remaining battery may change, it may possibly 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
Table3.3.2.1-1
Icon Paraphrase Description
Start Click this icon, start infusion
Stop Click this icon, infusion stop
Bolus/Purge
1. During infusion, it is『Bolus』function, click it to start fast infusion
2. Before infusion starting, it is『Purge』function, click it to exhaust air
from the IV set
Home Click this icon, return to the main interface
Input Method Interface
The input method interface composes of the title bar, input box, 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: It composes of the main button area and function button area.
The main button area is composed of the numerical values, and letters and icons.
The function button area is composed 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 for software upgrade and drop sensor
② DC Input Port
External 12V DC power supply
③ Handle
④ A/C Adapter Port
External 100-240V 50/60Hz AC power supply
⑤Loudspeaker
⑥Pole Clamp
Using for fixing the equipment on the infusion stand
⑦IrDA
Using for communicating with infusion docking station(Optional)
⑧Latch for stackable function

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4. Installation
Unpacking and Checking
1) Please check the appearance of the equipment when unpacking, if damaged please contact the
Shipping company or Triumph Medical service department 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 extended 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 qualified personnel.
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, and 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 enquiry.
When connecting the equipment with other electrical devices in special circumstances, and if the
combination can’t be confirmed dangerous or not, please contact our company or an electrical expert
to ensure that necessary safety measures are taken.
This equipment must be used and stored in the environment according to specifications in Section 2 of
this manual.

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Installing the Infusion Pump and Pole Clamp
(1) Install the pole clamp/cage mount using
provided 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 a pole 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 the fixing clamp;
loose it after tightening to avoid falling.
(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
¤ Mount the infusion pump on the IV stand:
¤ Power on: press for two seconds, Power on equipment
¤ Install IV Set
¤ Confirm IV set brand name: Select infusion tube brand
¤ Remove air bubble from the line
¤ Select infusion mode: Select infusion modes according to requirement
¤ Set infusion parameters: set infusion parameters according to requirement
¤ Connect the infusion line with the patient
¤ Start infusion: press , start infusion
¤ Infusion finish
¤ Remove the IV Set
¤ Power off or Standby

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6. Infusion Operation
Equipment Installation
Mount the device on the infusion stand/pole, connect with AC power supply，check that the AC
indicator lights are on. Battery will start to charge once AC power connected.
Starting and Self-test
1) Press for two second to power on the equipment.
2) After powering on, the system will automatically check the motor, sensor, battery, memorizer,
CPU communication, alarm indicator.
3) After passing the self-test, pump will enter into the rate mode interface.
Warning: ●If self-test failed, the pump cannot be used, please contact Triumph Medical.
Infusion Line Installation
1) Connect the IV line with the infusion bottle/bag.
2) Extrude the drip chamber, when the fluid has
reached 1/2 position of the drip chamber, open
the roller clamp.
3) Fill fluid/drug to the injection needle to remove
air, then close the roller clamp.
4) Pull the lock switch/door handle in the middle
of the pump door from the lower side, then open
the door.
5) Push up anti-free flow clamp to open it.
6) Install the infusion tube in the infusion tube slot according to direction indicator on the pump,
press the IV set in the pump inwards to make it attach to the peristaltic pump. Ensure that
items 1-8 shown in Drawing below are
correctly installed.
7) Manually push the pump door with both
thumbs on left and right side, it will make an
audible “click” sound after it is correctly
closed.
8) Verify correct IV Administration Brand.
Warning: ●It is suggested to use one of the
Infusion lines calibrated on this pump.

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●Please confirm that the infusion line brand and specification displayed in the display screen is
accordant with the actual one in use.
●If infusion accuracy is in question, the user is strongly suggested to contact Triumph Medical.
9) Install Drop sensor
Please install. After installing, click 『Settings』→『Drop sensor』to activate the drop sensor
function.
Caution ●The default state of drop sensor function is OFF, this function can be manually
activated by the user when the drop sensor is adopted.
Set Infusion Parameters
Purge Air
Under the parameters setting interface, Press 【Bolus】button on product panel and hold on, or
touch the screen purge icon to 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 with the
patient.
●Purge rate is set to the max flow rate, when purge volume ≥5ml, purge will automatically stop.
Start Infusion
Connect IV tube with patient, confirm IV Line Brand, confirm infusion parameters, Press【Start】
button , click 『yes』in the pop-up prompt interface, start infusion.

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Changing the Rate During infusion
Under the running interface, click rate number in touch screen and reset target infusion rate. Or
【Stop】 , and enter the parameters setting interface, then reset target infusion rate.
Note: ●Only the rate mode, drip mode and Body weight mode support online rate
modification function during infusion without pressing【Stop】
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 product panel, pump will work at
the max flow rate or set max bolus rate under the setting interface, release the button, pump will
go back to the previous setting 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. If ignored, the system will keep alarming until complete VTBI infusion.
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 30min, after reaching the time, it will activate
KVO completion alarm and stop infusion.

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Stop Infusion
During infusion or after infusion, click , infusion stop. It will return to the parameter setting
interface display Total Volume Infused and adjustable parameters.
Remove the Infusion Line
Disconnect the IV set’s extension line from the patient, then remove the IV set.
Replace IV set
Power OFF or Standby
Method 1: hold the 【Power】Button till the screen is OFF, the equipment is OFF.
Method 2: press the 【Power】Button to enter into OFF interface.
(1) Turn off the equipment: click 『Power off』icon, the equipment is turned OFF.
(2) Standby: click『Standby』icon to enter into standby time setting interface, set the standby time.
Under standby state, the screen brightness will be lowest, after standby, the screen brightness will
be recovered.
(3) Cancel: click『Cancel』, return to the interface before OFF setting.
Note:
●The equipment has a standby function available while not infusing.
Replace Infusion Line/Infusion Container
•Please replace the infusion tube assembly according to the following steps:
- Close the flow rate adjuster of the infusion tube assembly, open the infusion pump door, and then
remove the infusion tube assembly.
- Prefill and install the new infusion tube assembly.
- Operate to restart infusion according to the above infusion steps if needed.
•Please replace the fluid/drug container according to the following steps:
- Close the flow rate adjuster of the infusion tube assembly.
- Remove the fluid/drug container from the infusion tube assembly.
- Connect the infusion tube with the new fluid/drug container.
- Restart infusion according to the above steps of replacing infusion tube assembly.
Warning: ●The infusion tube will distort if it is used for a long period of time and could
result in inaccuracy or flow rate error, it is suggested to replace the pumping position or infusion
tube assembly after working for 8 hours or before depending on flow rate.

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Set Infusion Parameters
Introduction to Infusion Parameters Setting
(1) The drug information can be displayed in the infusion running interface only when the drug
library is under active state.
(2) Click『Settings』icon in the main interface to enter sub-menu, find 『Drug Library』menu
item, click to enter then select drug. To remove drug information from the running interface, go
back to Drug library and select “none”. Please refer to Drug Library on Page 21 for more info.
(3) For both the rate set in infusion parameter and the rate calculated by the system, the range is
the system default flow rate of the current working infusion line specification.
(4) If no VTBI (Volume to be infused) is Set then the fluid/drug in the infusion container will be
completely used.
Infusion Parameters Setting Range
Infusion Parameter Parameter Range
VTBI 0-9999.99ml
Rate 0.1-1500ml/h
Time 1min-99hrs59min
Weight(Body weight) 0.1-300kg
Conc.unit(Concentration unit)
mcg/ml, mg/ml, g/ml, U/ml, kU/ml, IU/ml, EU/ml,
mmol/ml, mol/ml, kcal/ml
Volume(Fluid amount) 0.1-9999.99ml
Dose rate 0.1-9999.99
Dose unit Unit(/kg)/min, Unit(/kg)/h,the Unit is Conc.unit
Drop rate 1-500 drops/min

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7. Infusion Mode Setting
After starting the equipment and self-test, the equipment automatically enters into the rate mode
parameters setting interface. To select the other modes, click『Menu』icon to enter into the
main interface. Click『Modes』icon to enter into the mode selection menu interface, and select
preset infusion mode.
Rate Mode
Under this mode it allows you to set rate and volume to be infused. Set the two parameters, and
the system will automatically calculate the third parameter. If volume to be infused is “0” pump
will work until pumps alarms.
Time Mode
Under this mode, it allows to set VTBI (Volume to be infused) and time. The system will
automatically calculate the speed, speed = Volume(ml) / time(min)
Body Weight Mode
Under this mode, set the Weight (body weight), Active agent (drug mass), Conc. unit
(concentration unit), Volume (fluid volume), Dose rate, Dose unit, VTBI.
The system will automatically calculate the flow rate from the specified dose rate (ug/kg/min,
mg/kg/min, ug/kg/h, mg/kg/h,…etc) according to related formula {dose rate × weight}/{Active
agent (drug mass)/Volume(fluid volume)}, and automatically calculate the time according to
(VTBI) /(flow rate).