KL 8052N User Manual
KL 8052N User Manual
KL 8052N User Manual
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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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.
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The following revision history table summarizes changes contained in this document.
The right is reserved to change or discontinue this product without notice.
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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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.
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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
• 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
• 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.
• 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. 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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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.
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• 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.
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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
• 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.
• 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.
• 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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• 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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• 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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7 SPECIFICATIONS
7.1 Infusion
7.2 Mechanical
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High priority
3s
100m 100m
s s
Middle priority
5s
200m
s
200m
s
Low priority
200m
s
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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8 SYMBOLS
Symbol Description
Manufacturer
Lot number
Serial number
IPX3
Waterproof level
AC
Grounding terminal
Type CF equipment
(protection against electrical shock)
Keep dry
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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.
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
2. Keep pressing [INCR] key and simultaneously switch on the pump, “FLOW
VOLUME mL
RATE” area displays “1111” (see Figure 1).
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
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
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
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9. Press [DECR] key, “FLOW RATE” area displays , the pump will calibrate the IV set at a high flow
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
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.
the top right corner of the pump. Select one switch for the new IV set brand and
2. Keep pressing [INCR] key and simultaneously switch on the pump, “FLOW
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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setting.
When high flow rate or high concentration liquid is required, the occlusion sensitivity can be adjusted to an
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
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
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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.
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10 V/m 10V/m
80 MHz to 2,5
Radiated RF GHz
IEC 61000-4-
3
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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.
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APPENDIX A Chart of flow rate VS time
1.1ml/h chart
• Charts for reference, data will vary when changing IV set or test conditions.