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KL 8052N User Manual

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KLJY-TF-8052N-001-EN

CONTENTS
1 INTRODUCTION..........................................................................................................................................1
1.1 Explanation of symbols.....................................................................................................................1
1.2 Features..........................................................................................................................................1
1.3 Revision history...............................................................................................................................2
2 DESCRIPTION OF PUMP..............................................................................................................................3
2.1 Front view......................................................................................................................................3
2.2 Rear view.......................................................................................................................................5
2.3 Power cord......................................................................................................................................5
3 PRIOR TO USE.............................................................................................................................................6
3.1 Warnings........................................................................................................................................6
3.2 Precautions.....................................................................................................................................7
3.3 Cleaning and disinfection..................................................................................................................7
3.4 Storage...........................................................................................................................................8
3.5 Maintenance and repair.....................................................................................................................8
3.6 Replace a fuse.................................................................................................................................9
3.7 Packing List....................................................................................................................................9
3.8 Alarm testing..................................................................................................................................9
3.9 Disposal of waste product.................................................................................................................9
4 OPERATION...............................................................................................................................................10
4.1 Install the pump on a pole stand.......................................................................................................10
4.2 Connect to AC power.....................................................................................................................10
4.3 Switch on the pump........................................................................................................................10
4.4 Press [START/STOP] key...............................................................................................................10
4.5 Prime an IV set..............................................................................................................................10
4.6 Install an IV set.............................................................................................................................11
4.7 Close the door...............................................................................................................................11
4.8 Set flow rate (ml/h, drop/min and time-based)....................................................................................11
4.9 Set VTBI (volume to be infused) (ml)...............................................................................................12
4.10 Open roller clamp of an IV set.........................................................................................................12
4.11 Insert a hypodermic needle into a patient...........................................................................................12
4.12 Press [START/STOP] key to start infusion.........................................................................................12
4.13 Infusion completion.......................................................................................................................12
5 SPECIAL FUNCTIONS................................................................................................................................14
5.1 System memory of infused volume & flow rate..................................................................................14
5.2 Reminder alarm function.................................................................................................................14
5.3 Temporarily stop infusion................................................................................................................14
5.4 Purge...........................................................................................................................................14
5.5 Clear infused volume......................................................................................................................14

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5.6 Run the pump with built-in battery...................................................................................................14


6 TROUBLE SHOOTING...............................................................................................................................16
7 SPECIFICATIONS.......................................................................................................................................19
7.1 Infusion........................................................................................................................................19
7.2 Mechanical...................................................................................................................................19
7.3 Alarm condition.............................................................................................................................19
7.4 Alarm sound parameters.................................................................................................................20
7.5 Delay of alarms.............................................................................................................................20
7.6 Features........................................................................................................................................20
7.7 Other parameters...........................................................................................................................21
8 SYMBOLS.................................................................................................................................................22
9 IV SET CALIBRATION...............................................................................................................................23
9.1 IV set calibration...........................................................................................................................23
9.2 Flow rate testing............................................................................................................................24
9.3 “drop/ml” calibration......................................................................................................................24
9.4 Occlusion sensitivity setting............................................................................................................25
10 EMC DECLARATION.................................................................................................................................26
11 WARRANTY..............................................................................................................................................29
APPENDIX A Chart of flow rate VS time..............................................................................................................30
APPENDIX B Bolus, duration, pressure value........................................................................................................31

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1 INTRODUCTION
1.1 Explanation of symbols

• Warning is used to indicate the presence of a hazard, which can cause severe personal injury,
death or substantial property damage if the warning is ignored.
• Caution is used to indicate the presence of a hazard, which will cause minor personal injury or
property damage if the warning is ignored.
• Note is used to notify the user of installation, operation or maintenance information, which is
important but not hazard-related.

Thank you for choosing our infusion pump.


In order to use this pump correctly and safely, read this manual carefully before operating the infusion pump. If you
have any questions as you are reading through this manual, call the local authorized dealer in your country. Retain this
manual together with the unit for future reference.
Intended use: The infusion pump is applied to patient by medical institution on intravenous infusion administration of
drugs and solutions.
• Contraindication: The infusion pump is not intended for the infusion of chemicals such as anti-
cancer drugs, oxytocic.
1.2 Features

• Compact in design, light in weight and small in size.


• Compatible with universal IV set.
• Low motor driving noise.
• Ultrasonic bubble sensor.
• Easy to set VTBI (volume to be infused) by [INCR] or [DECR] key on the front panel.
• Accurate setting of flow rate for patients.
• Flow rate accuracy with the equipped peristaltic finger system.
• The infused volume can be cleared by pressing [CLEAR] key without switching off the power.
• Audio-visual alarms for added safety.
• The reminder alarm sounds repeatedly if no action is taken within 2 minutes after the alarm was switched off.
• The flow rate can be set in 0.1ml/h increments.
• After delivering the VTBI, the pump continues running with keep vein open (KVO rate) mode.
• When door is open, the tube is automatically locked by tube clamp.
• The rechargeable built-in battery allows the pump to be transported with the patient without ceasing normal pump
operation.

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1.3 Revision history

The following revision history table summarizes changes contained in this document.
The right is reserved to change or discontinue this product without notice.

Revision No. Revision Date Description of Revisions


1.0 05/2013 Initial version.
1.1 03/2014 In accordance with the requirements of CE improvement.
1.2 11/04/2014 In accordance with the requirements of CE improvement.
1.3 17/06/2014 Update of European representative.
1.4 28/04/2015 Update pictures of front cover, rear view.

Please read this User’s Manual before operating the Infusion Pump.

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2 DESCRIPTION OF PUMP
2.1 Front view

1
3
4
5
6
7

10

2 11

12

1) LCD display
Wireless communication (optional function).
Pump powered by alternate current.
Pump powered by built-in battery.
Flashing indicates battery under charging.
Silence the alarm.
Indicate occlusion level.
Indicate pump under calibration
Alternate flash to indicate pump is running.
Light on when air bubble is in the IV tubing.
Light on when the IV tubing is occluded.
Light on when low battery.

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Light on when speed abnormal detected.


Light on when the door is open.
Light on when drop abnormal detected (This pump does not have this
function).
Light on when VTBI is completely delivered.
Pump run at KVO mode.
l Light on when the pump standby for 2 minutes.
Flow rate area.
Flow rate mode
drop/min mode.
Time-based mode.

Volume area.
Infused volume.
Volume to be infused.
Bolus volume (optional function).

2) Keys
[INCR] KEY: Increase. [START/STOP] KEY: start or stop
infusion, also act as a silence key.

[DECR] KEY: Decrease. [PURGE] KEY: Remove air in the IV


tubing.

[SET]KEY: Parameter settings. [CLEAR] KEY: Clear the infused


volume. Work under when pump stops.

Simultaneously press the two keys to change infusion


& mode: ml/h, drop/min and time-based.

3) Flow LED: Flash when infusion.


4) DIP switch: IV set selection.
5) Bubble sensor: Detects air bubble in the IV tubing.
6) Tension plate: Press on the tubing to generate pressure.
7) Fingers: Peristaltic press on the tubing to drive down the solution.
8) Door lever: Pull up this lever and close the door. Just push the door to lock it.
9) Tubing guider: Guide the IV tubing.
10) Pressure sensor: Detects the occlusion of the IV tubing.
11) Tubing clamp: Automatically clamps the IV tubing when the door is open.

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12) Pump door.


2.2 Rear view

1) Pole clamp
2) Grounding terminal
3) Pump handle
4) Power switch
5) AC power inlet
2.3 Power cord

AC power cord

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3 PRIOR TO USE
3.1 Warnings

• If this pump is used in the vicinity of the surgical operation equipment which generates a high frequency current such
as mobile (cellular) phone, radio, or defibrillator, the pump may malfunction since electrical interference.
Please carefully check for any sources of electrical interference in the vicinity before use.
• When using the pump concurrently with the surgical operation equipment, please note the following:
- Do not use the pump together with any surgical operation equipment that generates high noise level.
- Be sure that the pump is kept a sufficient distance from the surgical operation equipment.
- The pump and such device should not be powered from the same outlet.
- Check and confirm the normal operation of the pump periodically.
• In case of malfunction, turn off the power immediately, and remove IV set from the pump and
from the patients. After this action, please contact your local authorized dealer at once.
• Avoid using the pump in presence of flammable gases and flammable anesthetic mixture with air, oxygen or nitrous
oxide.
• The use of any mobile (cellular) phone near the pump is not allowed since the high frequency noise during the
conversation could cause malfunction of the pump.
• The use of the pump in MRI rooms such as high-pressure rooms or places where high electromagnetic radiation is
generated is not allowed.
• In case of using an IV set of your local brand, contact your local authorized dealer for compatibility of IV set with
this pump before use. If an improper IV set is used, the accuracy of flow rate and alarm functions cannot be
guaranteed.
• Be sure that the IV tubing is properly fit in the tubing slots of bubble sensor and occlusion sensor. If not, those alarms
will not function normally.
• Be sure that the IV tubing runs straight over the peristaltic finger section. If not, an accurate flow rate cannot be
guaranteed.
• During infusion, regularly check the drop rate to make sure that the solution is being infused at the selected rate.
• Do not connect the IV set administered from an infusion pump to another IV set administered only by the roller
clamp because this may cause inaccuracy of flow rate and alarm functions.
• The pump does not detect damage to the IV set such as a leak in the line or a rupture in the filter due to pressure
exertion. Therefore, regularly check for any damage to the IV set during infusion.
• When the flow is obstructed due to kinking of the IV tubing or clogging of the needle or filter, it can cause the
pressure increment in the IV set and cause the IV tubing to be inflated with the solution. Complete removal of the
obstruction will allow the solution to be delivered to the patient. If the flow is obstructed, take appropriate actions
after completely closing the roller clamp of IV set.
• The pump is connected to an AC power outlet to be operated. If there is no available AC power outlet, the pump can
be operated with only its built-in battery.
• The spill of the solution on the AC power inlet may cause a short circuit.

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• In case of malfunction, do not try to take the unit apart or attempt to repair by yourself. Please contact your local
authorized dealer immediately. If the user does not comply with these warnings, System cannot be held liable and
the warranty does not apply.
3.2 Precautions

• The pump does not detect if the solution is infused out of the blood vessel. Please check the puncture site and monitor
the patient’s condition carefully.
• Do not try to use the pump for other purposes such as blood transfusion.
• The pump is not portable equipment, Fix the pump securely to a pole stand and check its stability.
• The pump must be used in accordance with this instruction manual by trained medical personnel.
• Be sure to use components including power cord, provided or recommended in this manual.
• When alarm sounds, please take corrective actions. (Refer to troubleshooting)
3.3 Cleaning and disinfection

Before cleaning the pump, make sure to power off the pump and disconnect the AC power cord. Do not immerse the
pump in any liquid nor allow any liquid to leak into the pump. If spillage into the pump mechanism occurs, clean
immediately by wiping with a soft cloth.
• Do not use drier to dry the unit.
• Used pumps should be disinfected before use on another patient.
• Do not clean, disinfect or sterilize any part of the pump by autoclaving or with ethylene oxide
gas. Doing so may damage the pump and void the warranty.
• Do not use the following chemicals on the pump, as they will damage the front panel.
• Acetone, ammonia, benzene, hydroxytoluene, methylene chloride, n-alkyl dimethyl
ethylbenzyl ammonium chloride, and ozone.
• If cleansers or disinfectant solutions used, Follow manufacturers' dilution instructions for
concentrated cleansers or disinfectant solutions.

• Cleaning procedures:
Open pump door, use cloth sparingly dampened with any cleanser list in List 3.1. Wipe the split of bubble sensor. Wipe
peristalsis fingers. Wipe the occlusion sensor, tension plate and other surface in it. Close pump door, wipe enclosure
surface. Ensure that clean cloths do not become contaminated. Allow surfaces to remain wet for 30 seconds.
• Disinfection procedure:
Open pump door, use cloth sparingly dampened with any infectant solution list in List 3.2. Wipe the split of bubble
sensor. Wipe peristalsis fingers. Wipe the occlusion sensor, tension plate and other surface in it. Close pump door, wipe
enclosure surface.
List 3.1 recommended cleanser
A solution of 10% bleach and water
Soapy water
Isopropyl alcohol up to 75%

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Distilled water

Lists 3.2 recommend disinfectant solution and manufacture


Super Edisonite Edison Chemical Co.
Cleaner Manufacturer
LpH, Septisol Vestal Labs
Cidex 7 Surgikos
TOR or Hi-Tor Plus Huntington Labs
Super Edisonite Edison Chemical Co.
Bafix Hysan Corp.
3.4 Storage

• Avoid the following environment for storage and transport of the Infusion Pump
- Where the unit is exposed to dirt or heavy dust.
- Where the unit is exposed to salty atmosphere.
- Where the unit is exposed to severe vibration or corrosive gas.
- Where the unit is exposed to rough handling.
- Where the unit is exposed to direct sunlight or UV light.
- Where the unit is exposed to water.
- Where the unit is exposed to extreme temperature and humidity.
3.5 Maintenance and repair

• If any irregularity and failure are detected, stop operation of the pump immediately and contact your local authorized
dealer to repair or replace by supplying the details of the situation. Never try to disassemble or repair by yourself
because it could cause further serious failure.
• Make sure that there is any damage with the pump and components. In case that the unit and components were
shocked; do not use them even if visible damages are not observed. Please contact your local authorized dealer.
• Contact your local authorized dealer for periodical inspection of the pump for safety and longer product life.
• The pump can keep working for at least 3 hours at 30 ml/h when powered by fully charged built-in battery. If the
battery is low, the pump will stop running in 30 minutes if there is no way to connect the pump to an AC power
outlet. After that pump will keep alarm until battery is exhausted.
• Operate the pump with the built-in battery once a month to check its performance because the built-in battery is
subject to aging. If the operation time is getting short after it is normally recharged, contact your local authorized
dealer to replace with a new battery. Please be sure that your local authorized dealer checks it annually.
• Please recharge the built-in battery fully for more than 8 hours by connecting the pump to an AC power outlet before
the pump is used for the first time or after a long interval.
3.6 Replace a fuse

Pull the fuse holder out. Replace a fuse as the figure showed. Push the fuse holder to its position.

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Spare fuse

The fuse must be F0.25AL250V.


3.7 Packing List
No. Description Qty.
1 Infusion Pump 1
2 Power Cord 1
3 User’s Manual 1
4 Certificate 1
5 IV Set 1
3.8 Alarm testing
Self-checking when Switch on the pump, system program will check itself automatically: all lights will be on,
pump starts along with a beep.
Switch on the pump, when there is no IV set in bubble sensor slot, should display;
Bubble testing set up the IV set in bubble sensor slot after making sure IV set is full of liquid,
should be off.
Switch on the pump, set up the flow rate and VTBI. The pump alarms and
Occlusion testing
displays when IV set is blocked for a while.
Switch on the pump, when the door is opened, should display; when the door is
Opened-door testing
closed, should be off.

3.9 Disposal of waste product

• Waste product should be disinfected and sterilized before disposal. After that, please handle it refer to local laws.
• When battery reaches the end of life, do not throw it into fire or water; do not disassemble, recharge, or short it.
Please handle it refer to local laws.

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4 OPERATION
• When to press buttons or watch LCD, operator must face to pump front panel, with a distance
about 50 cm.
4.1 Install the pump on a pole stand

• Fix the pump securely on a pole stand, using the pole clamp at the
rear of the pump.
• Referring to right figure, put the pole into the pole clamp, and
fasten the screw as the arrow direction to fix the pump.
4.2 Connect to AC power

• Connect the provided AC power cord to the AC power inlet at the back of the pump and to an AC power outlet.
• Alternatively, the pump may be operated by built-in battery.

4.3 Switch on the pump

• When switch on the pump, the built-in battery will automatically come into being recharged.
• When turn on the power switch, all LCD will be flashing for 500ms, and give a beep. Then
pump enters standby mode. Please confirm the actions to make sure all LCD and speaker
can work properly.

• After flashing, as in the drawing below, [AC] LCD will automatically keep on.

• In standby status, LCD of volume display “Ln *” , shows the number of IV set
selected. LCD of rate alternate display “Oc **” and “dr **”, shows the occlusion sensitivity
setting and drop/ml setting. Refer to IV set calibration.
4.4 Press [START/STOP] key

• When pump in standby mode, press [START/STOP] key to let pump enter stop mode. In stop mode, pump displays
last successful infusion setting parameter of flow rate and VTBI... Flow rate and VTBI can be set in stop mode.
Infused volume can be cleared by pressing [CLEAR] key.
4.5 Prime an IV set

1. Connect IV set to the infusion (fluid) bag or solution container.


2. Fill the solution into the drop chamber up to one third.
3. By opening the roller clamp of the IV set, make a few drops of solution out of the hypodermic needle.
4. When priming is completed, close the roller clamp.
• Do not put the container 1.3m above or 0.5m below patient’s heart, otherwise rate precise can’t
assurance.
4.6 Install an IV set

1. Open the door set the IV tubing properly in place, make sure that the tubing sits in the bubble sensor and keeps

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straight through the peristaltic finger and the occlusion sensor.


2. Push the tubing clamp and clamp the IV set.
• If the IV set does not keep straight over the Peristaltic finger section, the desired flow rate may
not be achieved.
• When the same site of the tubing has been set at peristaltic finger section for a long time (over 3
hours), use it after moving the IV tubing connected to this pump at a distance of more than 10 cm.
Deformation of IV tubing arising from long time (over 3 hours) use can affect the accuracy.
• The tube should be replaced with a new one every 24 hours.
• If there is a need to replace IV set with a new one while using the pump, follow the below
procedure.
1)Stop the operation
2)Open the door, close the roller clamp, and remove IV set
3)Replace IV set and prime the IV set
4)Set IV set back properly in place
5)Close the door and open the roller clamp
6)Restart infusion
4.7 Close the door

• Close the door.


• Make sure the IV set is not clamped by the door.

4.8 Set flow rate (ml/h, drop/min and time-based)

1.Simultaneously press [DEC] [SET] key to select flow rate mode.


• The flow rate area will toggle display ‘ml/h’ , ‘drop/min’ and time-based, make sure the unit of
flow rate displays properly. Wrong unit will cause big error.

2.Press [INCR] or [DECR] key at flow rate area to increase or decrease the flow rate.
• Keep pressing [INCR] or [DECR] key, the digital will increase or decrease continuously.
• Keep pressing [INCR] or [DECR] key for several seconds, the digital will change faster.
• The flow rate range is as follows
1~1100 ml/h (in 0.1 ml/h increments)
1~366 drop/min (in 1 drop/min increments)
• This is a volumetric infusion pump. Both drop/min and time-based are calculated as ml/h and
start at that rate.

4.9 Set VTBI (volume to be infused) (ml)

• The VTBI can be set from 1 to 9999ml in 1ml increments.


• The pump initially displays the infused volume of last operation.
• Press [INCR] or [DECR] key to increase or decrease the VTBI.
• Keep pressing [INCR] or [DECR] key, the digital will increase or decrease continuously.
• Keep pressing [INCR] or [DECR] key for several seconds, the digital will change faster.

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• The flow rate range is as follows


1~9999 ml (in 1ml increments)
• Make sure that the VTBI should be set slightly lower than the amount of solution in the solution
container so that the pump can continue the infusion at the lowest rate (KVO rate) after the
infusion completion.
• Infusion will not start in case that the VTBI is set at 0000 ml
• After starting infusion, the LCD displays infused volume in about 3 seconds.
4.10Open roller clamp of an IV set

• Open roller clamp of an IV set.


• Make sure that the solution neither comes into the drop chamber nor comes out of the needle. If
solution does, please confirm that IV set is of a recommended type, that the IV tubing is set
properly, and IV set is in good condition. When none of the above is found, the pump fault may be
suspected. Stop the operation of the pump and contact your local authorized dealer
4.11Insert a hypodermic needle into a patient

• Insert a hypodermic needle into a patient.


• The pump is not designed to detect if the solution is infused out of blood vessel. Please regularly
check the puncture site and monitor the patient’s condition carefully.
4.12Press [START/STOP] key to start infusion

• Before operating the pump, make sure to check flow rate, VTBI, “drop/ml” and the IV set again.
• Press [START/STOP] key to start infusion, pump enters run mode.
• [FLOW] LED on top of the pump door flickers. This means the pump is running.
• Check the drop rate of the solution to make sure that it is being delivered at the selected flow rate.
• If any irregularity is observed, immediately stop the pump and contact your local authorized
dealer.
4.13Infusion completion

• When the infused volume reaches the VTBI, the “FINISH” indicator will be on, along with alarm sound. The pump
continues the infusion at the following KVO rate.

Flow rate setting KVO rate


>= 4ml/h 4 ml/h
< 4ml/h Same as flow rate setting
• Pressing [START/STOP] key to stop KVO mode.
• Before opening the door of the pump in order to release the tubing clamp and remove the IV set,
make sure to close the roller clamp completely.
• Free flow will occur if the IV set is removed or the tubing clamp is released without completely

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closing the roller clamp.

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5 SPECIAL FUNCTIONS
5.1 System memory of infused volume & flow rate

• Switch on pump, the infused volume and flow rate that were set previously are shown on the LCD. The infused
volume & flow rate can be kept for 8 years in the internal memory.
• The new value can be set by pressing [INCR] or [DECR] key.
5.2 Reminder alarm function

• When pump in stop mode, if no corrective action is taken within 2 minutes the alarm will sound. Press any key to
silence the alarm.
5.3 Temporarily stop infusion

• Press [START/STOP] key, pump stops and enters stop mode.


• Before restarting the infusion, make sure to check the flow rate, VTBI and “drop/ml” that were set and then press
[START/STOP] key.
5.4 Purge

• When [PURGE] key is double pressed and held, the pump delivers the solution at a flow rate of 700 ml/h.
• In “STOP” mode, Purge function can be used for removing air in IV set.
• In “RUN” mode, The volume infused by purging is added to the value of total infused volume
Alarms will not work while purging. Make sure the pump is in normal condition after purging.

5.5 Clear infused volume

• In stop mode, if the [CLEAR] key is pressed, the infused volume will become “0”.
• Before restarting the infusion, make sure that the parameters of flow rate, VTBI and “drop/ml”
are set correctly. If different, set flow rate, VTBI and “drop/ml” again.
• In case of restarting infusion after clearing the infused volume, the pump will start to deliver the
solution newly from “0” to the VTBI specified previously if the new VTBI setting is not taken.
5.6 Run the pump with built-in battery

• The pump is automatically switched to the built-in battery and [LOW BATT] LCD lights on when the AC power is
not supplied.
• The built-in battery is recharged by connecting the pump to an AC power outlet when pump is stwitched on.
• The pump can be operated on the built-in battery for about 3 hours at 30ml/h.
• When the battery is new, it should be recharged for more than 8 hours.
• During infusion, if [LOW BATT] LCD light on with the alarm sound, the built-in battery should
be recharged by connecting the pump to an AC power outlet without pressing any key, otherwise
the pump may stop running because it means the voltage of the built-in battery will be depleted in

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30 minutes
• When the voltage of the built-in battery is depleted the pump will stop running with the alarm.
• The battery is subject to aging. Please have your local authorized dealer check it annually.
• To keep the battery in good condition, fully recharge it at least once a month even if it is not used
for a long time.
• Please confirm if the built-in battery works properly by turning on the infusion pump without
connecting to an AC power outlet once a month.
• When using the pump for the first time, or if it is used after a long interval, recharge the built-in
battery fully by connecting the pump to an AC power outlet for more than 8 hours.

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6 TROUBLE SHOOTING
Take the following actions if any trouble occurs. When the troubles could not be solved with the following actions,
Please contact your local authorized dealer immediately.
• Whenever alarm sounds, the pump will stop infusion and indicator on LCD is flickering.

Symptom Cause Action


Pump cannot be • AC power cord is Check the AC power cord connection.
switched on. not inserted properly

• Built-in battery has Stop the operation of the pump and replace with a new battery
deteriorated. through your local authorized dealer.
• The voltage of the Recharge the battery fully for more than 8 hours by connecting the
built-in battery is pump to an AC power outlet and turn it on.
low.
The [AIR] LCD • Air bubble in IV 1. Turn the alarm off by pressing [START/STOP] key. Pump
light on and alarm set. enters “stop” mode.
sounds • IV set is not 2. Close the roller clamp of the IV set
continuously properly placed. 3. Take the IV set from the pump and tap the tube to make the
• Bubble sensor is air bubble gather into the drop chamber.
stained. 4. In case that bubble sensor is stained, clean it with a gauze
cloth or similar, moistened with cold or tepid water.
5. Set the IV set backs properly in place.
6. Close and lock the door securely.
7. Open the roller clamp of the IV set.
8. Make sure that the parameters of flow rate, VTBI and “drop/
ml” are set correctly.
9. Restart infusion by pressing [START/STOP] key.
• IV set is not Check the compatibility of IV set with your local dealer.
compatible with this
pump.
The • The roller clamp is 1. Turn the alarm off by pressing [START/STOP] key. Pump
[OCCLUSION] closed. enters “stop” mode.
LCD light on and 2. Open the roller clamp on IV set.
alarm sounds 3. Make sure that the parameters of flow rate, VTBI and
continuously “drop/ml” are set correctly.
4. Restart infusion by pressing [START/STOP] key.

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Symptom Cause Action


• IV set is not Check the compatibility of IV set with your local dealer.
compatible with this
pump.

• IV Tubing is kinked 1. Turn the alarm off by pressing [START/STOP] key. Pump
or twisted enters “stop” mode.
• IV set is not properly 2. Close the roller clamp on IV set.
placed 3. Open the door and take the IV set from the pump, check the IV
• IV Tubing is set and take a corrective action like untwisting or replacing
stretched or shrunk with a new one to solve the problem of occlusion.
4. Set the IV set back properly in place.
All red LCD flash • Battery is depleted, 1. Turn off power switch at the back of pump.
and alarm sounds when pump powered 2. Plug in AC power cord, if it isn’t plugged in.
continuously. by built-in battery 3. Turn on power switch at the back of pump.
“Er-1” or “Er-2” 4. LCD should flash, if not stop the operation of the pump and
show on the replace with a new battery through your local authorized
LCD. dealer. If battery be charged normally go to next step.
5. Make sure that the parameters of flow rate, VTBI and “drop/
ml” are set correctly.
6. Restart infusion by pressing [START/STOP] key.
If this symptom happens again and again, please contact your
local authorized dealer to replace the battery.
• Peristaltic finger 1. Turn the alarm off by pressing [START/STOP] key. Pump
system out of work. enter “stop” mode.
2. Restart infusion by pressing [START/STOP] key.
3. Listen close to peristaltic finger system, if there isn’t any
noise; contact your local authorized dealer.
All red LCD flash • The setting of “drop/ 1. Set the correct “drop/ml”. (Refer to IV set calibration).
and alarm sounds ml” is not correct.

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KLJY-TF-8052N-001-EN

Symptom Cause Action


continuously. • The same site of the 1. Turn the alarm off by pressing [START/STOP] key.
tubing has been set at 2. Close the roller clamp on IV set.
peristaltic finger 3. Open the door. Either move the IV tubing connected to this
section for a long time pump at a distance of more than 10cm to reset or replace IV
(over 3 hours). set with a new one.
• IV tubing is not 4. Set the IV set back properly in place.
properly placed 5. Close and lock the door securely.
6. Open the roller clamp of IV set.
7. Make sure that the parameters of flow rate, VTBI and “drop/
ml” are set correctly.
8. Restart infusion by pressing [START/STOP] key.
• IV set is not Check the compatibility of IV set with your local dealer.
compatible with this
pump.
“Er-P”” shows on • Occlusion sensor is Follow the steps for shift IV set. Try to dismount IV set and
the LCD. Cannot abnormal mount it again.
start the pump. If this symptom happens again and again, please contact your
local authorized dealer to replace the battery.
All red LCD flash • Program is Check if there exists some strong interfere, or failure of power
and alarm sound abnormal. system, or pump very close to a heavy load. Try to use pump at a
continuously. stable environment. Power cycle the pump and use it.
If this symptom happens again and again, please contact your
local authorized dealer.

• Before restarting infusion, Make sure that the parameters of flow rate, VTBI and “drop/ml”
are set correctly.
• After restarting infusion, check flow rate to confirm the delivery of the solution at the
selected rate.
TROUBLE SHOOTING - OTHERS
In this pump, flow rate is not controlled by drop sensor. Therefore, to correct the fluctuations of volume of a drop
caused by viscosity of solution, flow rate and VTBI should be compensated. Please refer to IV set calibration.
• Without the above compensation, the actual flow rate might be lower than intended but
the pump could not detect it.

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KLJY-TF-8052N-001-EN

7 SPECIFICATIONS
7.1 Infusion

IV SET Compatible with IV sets of any standard


FLOW RATE 0.1-1500 ml/h (in 0.1 ml/h increments)
PURGE, BOLUS 100-1500 ml/h (in 1 ml/h increments)
Purge when pump stops, bolus when pump starts
BOLUS VOLUME 1-20 ml (in 1 ml increments)
ACCURACY ±3%
THERMOSTAT FOR IV TUBING 30-45℃, adjustable
VTBI (VOLUME TO BE INFUSED) 1-9999 ml
INFUSION MODE ml/h, drop/min, time-based
KVO RATE 0.1-5 ml/h (in 0.1 ml/h increments)

7.2 Mechanical

PUMPING MECHANISM Linear peristaltic finger


DIMENSIONS (W×D×H) 174×126×215 mm without pole clamp
WEIGHT Approximately 2.5 kg
WATER PROOF CLASSIFICATION IPX3

7.3 Alarm condition

Alarms Priority Alarm condition


AIR IN LINE High When air bubble in IV tubing.
OCCLUSION High When IV tubing is occluded.
DOOR OPEN High When pump door is open.
FLOW RATE ABNORMAL High When flow rate is 20% faster or slower than set rate.
INFUSION COMPLETION Middle When VTBI is delivered.
LOW BATTERY Middle When battery capacitor is low.
REMINDER ALARM Middle No operation and pump in standby mode in 2 minutes.
AC FAILURE Low AC power off.
All alarms are TECHNICAL alarm.

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7.4 Alarm sound parameters

High priority
3s
100m 100m
s s

300m 500m 300m


s s s

Middle priority

5s
200m
s
200m
s

Low priority

200m
s

7.5 Delay of alarms

Alarms Alarm condition delay Alarm signal generation delay


AIR IN LINE 125ms 75ms
OCCLUSION 20S 200ms
LOW BATT 1S 200ms
DOOR OPEN 1S 200ms
FLOW RATE 2160S @ 1ml/h 200ms
ABNORMAL 90S @ 25ml/h
FINISH 10ms 200ms
AC FAILURE 1S 200ms
REPEAT 120S 200ms
ALARM

7.6 Features

ALARMS Occlusion, air-in-line, door open, end program, low battery, end
battery, AC power off, motor malfunction, system malfunction,
reminder alarm
ADDITIONAL FEATURES Real-time infused volume / bolus rate / bolus volume / KVO
rate, automatic power switching, mute button, purge, bolus,

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KLJY-TF-8052N-001-EN

system memory, key locker, change flow rate without stopping


the pump

7.7 Other parameters

POWER REQUIREMENTS AC 230V, 50Hz


POWER CONSUMPTION 20VA
ALARM SOUND PRESSURE Over 65db @ 1m distance
CLASSIFICATIONS Class I / built-in power supply / Type CF
BATTERY / OPERATION / CHARGING Ni-MH / 5 hours (at 30 ml/h) / more than 8 hours
BATTERY LIFE 2 years
OPERATION CONDITIONS 10~30℃, 30~75% RH (no condensation)
STORAGE CONDITIONS -20~55℃, ≤93% RH (no condensation)
WARRANTY PERIOD 1 year
ALTITUDE 2000 meters
※Specifications and design are subject to change for improvement without prior notice

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8 SYMBOLS
Symbol Description

Caution, consult accompanying documents

Manufacturer

Consult instructions for use

Lot number

Serial number

IPX3
Waterproof level

AC

Grounding terminal

Do not throw it into wastebin

Type CF equipment
(protection against electrical shock)

Stack products not exceed 3 packages

Keep dry

Storage conditions: -20~55℃

Authorized representative in the European Union

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KLJY-TF-8052N-001-EN

9 IV SET CALIBRATION
9.1 IV set calibration

• Use Infusion Pump for the first time or change a new brand of IV set, Calibration is needed. If
infusion accuracy get worse or work Condition changed for example temperature, humidity
changed. Calibrate the IV set can get a better infusion accuracy.
• Infusion accuracy can not be guaranteed if non-calibrated or non-compatible (as mentioned in
Chapter 7) IV sets are used.
Please follow the steps below to calibrate an IV set.

Materials required but not provided: 10 ml cylinder / syringe.

1. Open pump door, there are six DIP switches for each specific IV set, located at
FLOW RATE
the top right corner of the pump. Select one switch for the new IV set brand and

keep a record. Close pump door.

2. Keep pressing [INCR] key and simultaneously switch on the pump, “FLOW
VOLUME mL
RATE” area displays “1111” (see Figure 1).

3. Press [DECR] key, “FLOW RATE” area displays . “VOLUME” area

SET
displays “0.0”. The pump will calibrate the IV set at a low flow rate.

4. Put the hypodermic needle in the cylinder / syringe. Open roller clamp. START
STOP
CLEAR
PURGE

5. Press [START/STOP] key to start calibration.


Figure 1 IV set calibration
6. The pump stops when “VOLUME” area displays “5.0” or a proper number. Read the real value of the infused

liquid in the cylinder / syringe. Enter the real value in the “VOLUME” area by pressing [INCR] or [INCR]

key. Press [START/STOP] key to save the calibration data of the low flow rate. Remove the infused liquid

from the cylinder / syringe.

7. It is strongly recommended to repeat “STEP 5-6” twice to get a better accuracy, at least get a real value of

“5.0”.

8. Press [DECR] key, “FLOW RATE” area displays , the pump will calibrate the IV set at a medium

flow rate. Repeat “STEP 5-7”.

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9. Press [DECR] key, “FLOW RATE” area displays , the pump will calibrate the IV set at a high flow

rate. Repeat “STEP 5-7”.

10. Restart the pump and ready for infusion.

Please repeat “STEP 1-10” to calibrate other IV sets.

• To get good performance, carefully measuring and operation are recommended.


A list is provided; customs can fill the list after calibration.

No. IV set Note


1
2 Hanaco Calibrated
3 JieRui Calibrated
4
5
6
9.2 Flow rate testing

1. Prepare tools: IV set, 10 ml cylinder / syringe, chronograph.

2. Refer to Chapter 4, Set up IV set, Set VTBI to 5 ml, Set flow rate to 25ml/h, put hypodermic needle in the cylinder

/ syringe, press [START/STOP] key and start chronograph simultaneously.

3. Wait for infusion completion, and stop the chronograph. Check infused volume in the cylinder, it should be 5 ml

±5%. Check infusion time, it must be 12 min ±1%. Otherwise, recalibration is recommended.

9.3 “drop/ml” calibration


• drop/ml varies with different IV set, it is recommended to set drop/ml for the IV set to be used.
1. Open pump door, there are six DIP switches for each specific IV set, located at

the top right corner of the pump. Select one switch for the new IV set brand and

keep a record. Close pump door.

2. Keep pressing [INCR] key and simultaneously switch on the pump, “FLOW

RATE” area displays “1111” as figure 1.

3. Press [INCR] key again, “FLOW RATE” area displays “2222” (see Figure 2).

4. Press “SET” key, “20” will be flickered. Enter the expected drops by pressing

[INCR] or [DECR] key. Press [START/STOP] key to save the data of drop/ml

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KLJY-TF-8052N-001-EN

setting.

5. Restart the pump and ready for infusion.

• drop/ml value is limited between 10~30.


• After setting drop/ml, rate convert change to ml/h = drop/min / (drop/ml) * 60.
9.4 Occlusion sensitivity setting

When high flow rate or high concentration liquid is required, the occlusion sensitivity can be adjusted to an

appropriate value. The default value is 2.

1. Open pump door, there are six DIP switches for each specific IV set, located at
FLOW RATE
the top right corner of the pump. Select one switch for the new IV set brand

and keep a record. Close pump door.

2. Keep pressing [INCR] key and simultaneously switch on the pump, “FLOW
VOLUME mL
RATE” area displays “1111” (see Figure 1).

3. Press [INCR] key again, until “FLOW RATE” area displays “4444”. Press

[DECR] key twice, until the pump displays “Pr-2” (see Figure 3).
SET

4. Press [SET] key. Select the expected sensitivity level (level 1, 2, 3) by


START CLEAR
pressing [INCR] or [DECR] key. Press [START/STOP] key to save occlusion STOP PURGE

Figure 3 Occlusion Sensivity Setting


sensitivity.

5. Restart the pump and ready for infusion.

The maxim infusion pressure is set at 0.3~0.4 MPa.


Highest sensitivity is limited to 1 and lowest sensitivity is limited to 3. The list below is
occlusion alarm threshold.
1: 0.06 ~ 0.11 MPa
2: 0.09 ~ 0.14 MPa
3: 0.13 ~ 0.18 MPa

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10 EMC DECLARATION
The infusion pump needs special precautions regarding EMC and needs to be installed and put into service according to
the EMC information provided in the accompanying documents;
Portable and mobile RF communications equipment can affect the infusion pump.
All cables and maximum length of cables and other accessories with which the manufacturer of the infusion pump
claims compliance with the requirements, Accessories that do not affect compliance with the
requirements of these sub clauses need not be listed. Accessories and cables may be specified either
generically or specifically.
• Cables sold by the manufacturer of the infusion pump as replacement parts for built-in
components need not be listed.

The use of accessories and cables other than those specified, with the exception of cables sold by the manufacturer of
the infusion pump as replacement parts for built-in components, may result in increased emissions or decreased
immunity of the infusion pump.

Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS


The infusion pump is intended for use in the electromagnetic environment specified below. The customer or the user
of the infusion pump should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions Group 1 The infusion pump uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF emissions Class  A
CISPR 11
Harmonic emissions Not Comply
IEC 61000-3-2
Voltage fluctuations/ Not Comply
flicker emissions
IEC 61000-3-3
Guidance and manufacturer’s declaration – electromagnetic immunity
The infusion pump is intended for use in the electromagnetic environment specified below.
The customer or the user of the infusion pump should assure that it is used in such an environment.
IMMUNITY IEC 60601 Compliance level Electromagnetic environment –
test test level guidance
Electrostatic ± 8 kV contact ± 2,4, 6, 8 kV Floors should be wood, concrete or ceramic tile. If
discharge (ESD) ± 15 kV air contact floors are covered with synthetic material, the
IEC 61000-4-2 ± 2,4,8,15 kV air relative humidity should be at least 30 %.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be that of a typical
transient/burst supply lines supply lines commercial or hospital environment.
IEC 61000-4-4 ± 1 kV for ± 1 kV for
input/output input/output
lines lines
Surge ± 1 kV line(s) to ± 1 kV line(s) to Mains power quality should be that of a typical
IEC 61000-4-5 line(s) line(s) commercial or hospital environment.
± 2 kV line(s) to earth ± 2 kV line(s) to
earth
Voltage dips, <5 % UT <5 % UT Mains power quality should be that of a typical
short (>95 % dip in UT) (>95 % dip in UT) commercial or hospital environment. If the user of
interruptions and for 0,5 cycle for 0,5 cycle the infusion pump requires continued operation

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KLJY-TF-8052N-001-EN

voltage 40 % UT 40 % UT during power mains interruptions, it is


variations (60 % dip in UT) (60 % dip in UT) recommended that the infusion pump be powered
on power supply for 5 cycles for 5 cycles from an uninterruptible power supply or a battery.
input lines 70 % UT 70 % UT
IEC 61000-4-11 (30 % dip in UT) (30 % dip in UT)
for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 s for 5 s
Power 400 A/m 400 A/m Power frequency magnetic fields should be at
frequency (50/60 levels characteristic of a typical location in a
Hz) magnetic typical commercial or hospital environment.
field
IEC 61000-4-8
Guidance and manufacturer’s declaration – electromagnetic immunity
The infusion pump is intended for use in the electromagnetic environment specified below.
The customer or the user of the infusion pump should assure that it is used in such an environment.
IMMUNITY IEC 60601 test Complianc Electromagnetic environment –
test level e level guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the infusion pump, including
cables, than the recommended separation distance
Conducted 3 Vrms calculated from the equation applicable to the frequency of
RF 150 kHz to 80 3V the transmitter. 
IEC 61000-4- MHz
6 outside ISM
bandsa

10 V/m 10V/m
80 MHz to 2,5
Radiated RF GHz
IEC 61000-4-
3

Recommended separation distances between portable and mobile RF communications equipment and


the infusion pump
The infusion pump is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the infusion pump can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
infusion pump as recommended below, according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output powerof m
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W

0,01 0.117 0.117 0.233

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KLJY-TF-8052N-001-EN

0,1 0.36999 0.36999 0.73681


1 1.17 1.17 2.33
10 3.69986 3.69986 7.36811
100 11.7 11.7 23.3

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KLJY-TF-8052N-001-EN

11 WARRANTY
The Infusion Pump has been carefully manufactured from the highest quality components. The pump is guaranteed
against defects in material and workmanship for twelve (12) months from the date of shipment.

Manufacturer’s obligation, or that of its designated representative under this Warranty, shall be limited, at our option, to
repairing or replacing the pump, which upon examination, is found to be defective in material or workmanship. The
repair or replacement of any product under this Warranty shall not extend the above mentioned Warranty period.

Only qualified, trained service personnel should undertake all repairs under this Warranty. In the event that a pump is
found to be defective during the warranty period, the purchaser shall notify manufacturer or its designated
representative within thirty (30) days after such defect is discovered.

The defective pump should be sent immediately to manufacturer or its designated representative for inspection, repair
or replacement. Returned pump should be properly packaged to avoid damage.

This Warranty shall not apply to defects or damage caused, wholly or in part, by negligence, spilt fluids, dropping of
the pump, misuse, abuse, improper installation or alteration by anyone other than qualified, trained personnel; or to
damage resulting from inadequate packaging in returning the pump.

This Warranty is the sole and entire warranty pertaining to manufacturer’s products and is in lieu of and excludes all
other warranties of any nature whatsoever, whether stated, or implied or arising by operation of law, trade, usage or
course of dealing, including but not limited to, warranties of merchantability and warranties of fitness for a particular
purpose.

Purchaser expressly agrees that the remedies granted to it under this Warranty are purchaser’s sole and exclusive
remedies with respect to any claim of purchaser arising under this Warranty.

XXXI
APPENDIX A Chart of flow rate VS time
1.1ml/h chart

1ml/h bugle shape chart

1ml/h flow rate chart


2.25ml/h chart

25ml/h bugle shape chart

25ml/h flow rate chart


• Charts for reference, data will vary when changing IV set or test conditions.
APPENDIX B Bolus, duration, pressure value
The duration of giving an alarm, pressure value and bolus value when IV tubing occluded.
Flow Rate Pressure Value Duration (h/m/s) Bolus (g)

1 ml/h ≦0.08 MPa ≦1/15/0 ≦0.94

25 ml/h ≦0.08 MPa ≦0/2/23 ≦0.87

1100 ml/h ≦0.08 MPa ≦0/0/5 ≦0.86

• Charts for reference, data will vary when changing IV set or test conditions.

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