Triumph IP12 Manuel utilisateur
User Manual
Triumph IP12 Infusion Pump
2
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
6
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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