Operator Manual of Infusion Pump HX-801E

INFUSION PUMP
HX-801E
OPERATOR MANUAL

Guangzhou Huaxi Medical Science Technology Co., Ltd.

Please read this manual completely prior to using the device!

Version: V1.1
 Operator Manual of Infusion Pump HX-801E

Table of contents
Chapter 1 Safety Precautions ....................................................................................... - 3 -
Chapter 2 Introduction ................................................................................................. - 5 -
2.1 Application ....................................................................................................................................... - 5 -
2.2 Specifications ................................................................................................................................... - 5 -
2.3 Working conditions .......................................................................................................................... - 6 -
2.4 Compliance ...................................................................................................................................... - 6 -
2.5 Features ............................................................................................................................................ - 6 -
2.6 Components and functions ............................................................................................................... - 7 -
Chapter 3 Operation Guidance................................................................................... - 10 -
3.1 Operation flowchart ....................................................................................................................... - 10 -
3.2 Infusion pump installation ............................................................................................................. - 10 -
3.3 IV set installation ........................................................................................................................... - 10 -
3.4 Infusion parameter setting .............................................................................................................. - 12 -
3.4.1 Infusion mode setting ............................................................................................................... - 12 -
3.4.2 IV set selection ......................................................................................................................... - 12 -
3.4.3 Infusion volume setting............................................................................................................ - 12 -
3.4.4 Infusion rate setting.................................................................................................................. - 13 -
3.4.5 Infusion time setting ................................................................................................................ - 13 -
3.4.6 Total infused volume ................................................................................................................ - 14 -
3.4.7 Bolus mode .............................................................................................................................. - 14 -
3.5 Priming ........................................................................................................................................... - 14 -
3.6 Start the infusion ............................................................................................................................ - 15 -
3.7 Stop infusion .................................................................................................................................. - 15 -
3.8 Infusion finish ................................................................................................................................ - 15 -
3.9 Power off ........................................................................................................................................ - 15 -
3.10 System management .................................................................................................................... - 15 -
3.10.1 Occlusion sensitivity setting .................................................................................................. - 15 -
3.10.2 Air-in-line sensitivity setting.................................................................................................. - 16 -
3.10.3 Sound volume setting............................................................................................................. - 16 -
3.11 Unit convert .................................................................................................................................. - 16 -
3.12 Manage IV set .............................................................................................................................. - 17 -
3.12.1 Calibration value setting ........................................................................................................ - 17 -
3.12.2 Add new brand of IV set ........................................................................................................ - 17 -
3.12.3 Auto calibration ...................................................................................................................... - 17 -
3.12.4 Calibration by manual ............................................................................................................ - 18 -
3.12.5 Adjust calibration value for high concentration solution ....................................................... - 19 -

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 Operator Manual of Infusion Pump HX-801E

3.12.6 Delete a brand of IV set ......................................................................................................... - 20 -

3.13 Others ........................................................................................................................................... - 20 -
3.13.1 Change of container ............................................................................................................... - 20 -
3.14 Alarms and errors ......................................................................................................................... - 20 -
3.14.1 Alarms .................................................................................................................................... - 20 -
3.14.2 Other errors ............................................................................................................................ - 23 -
3.15 Daily check................................................................................................................................... - 23 -
Chapter 4 Maintenance .............................................................................................. - 23 -
4.1 Daily Maintenance ......................................................................................................................... - 23 -
4.1.1 Clean the housing ..................................................................................................................... - 24 -
4.1.2 Clean the air sensor .................................................................................................................. - 24 -
4.1.3 Clean the finger pump cassette ................................................................................................ - 24 -
4.1.4 Clean the tube clamp ................................................................................................................ - 24 -
4.1.5 Clean the drip sensor ................................................................................................................ - 24 -
4.2 Battery ............................................................................................................................................ - 24 -
4.2.1 General guidance ..................................................................................................................... - 24 -
4.2.2 Replace battery......................................................................................................................... - 25 -
4.3 Periodical replacement for accessories .......................................................................................... - 25 -
4.4 Transportation and storage conditions ........................................................................................... - 25 -
Chapter 5 Appendix ................................................................................................... - 26 -
5.1 Trumpet curve ................................................................................................................................ - 26 -
5.2 Guidance and manufacturer’s statement on anti-electromagnetic interference Ⅰ ........................ - 27 -
5.2 Guidance and manufacturer’s statement on anti-electromagnetic interference Ⅱ ........................ - 29 -

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 Operator Manual of Infusion Pump HX-801E

Chapter 1 Safety Precautions

Thank you for choosing the HX-801E infusion pump produced by Huaxi.
Please read this operator manual completely prior to using this device. Please
carry out inspection and maintenance to the pump periodically according to
the manual in order to avoid patient/user injury.

1. HX-801E must be operated by medical professional staff, such as

doctors, nurses, etc.
2. HX-801E is not explosion-proof or portable device.
3. Do not operate this device in environments where there are gas mixtures
of flammable anesthetic, oxygen and oxidize ammonia, etc.
4. To avoid patients being injured by over-flow or under-flow, please set
infusion parameters correctly and calibrate before using a new IV set.
5. If anything abnormal is found, stop using this device at once.
6. To avoid malfunctions, maintain the recommended protective distances
for the devices that cause strong electromagnetic wave or noise, such as
nuclear magnetic resonance device, microwave generating device and
radiological device (X-ray machine or CT machine).
7. To avoid malfunctions, keep this device at least 25 meters away from
high-frequency surgical instruments, such as knife holder, knife cable,
electrode feeder board, and keep this device at least 1 meter away from
mobile phone.
8. It is not allowed to use voltage other than that specified on the product
label, or else it might cause damage or even fire.
9. The battery should not be heated or throw into fire, otherwise it might
cause leakage, fire or even explosion.
10. Do not tear off the battery sheath, otherwise it might cause explosion or
chemical burns.
11. Hold the plug tightly when plugging in or unplugging the AC electric
wire. Don’t touch the plug with wet hands.

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12. It’s better not to share a socket with other devices.

13. It’s not allowed to dismount or modify the device without permission.
14. The device should be checked daily, and all functions should be checked
prior to use if the device has not been used for a long time.
15. If any abnormality or absence of any function, please stop using the
device and contact the supplier as soon as possible. Otherwise the
manufacturer/seller will assume no responsibility for the loss, damage or
injury.
16. Do not shake or crash the device. Keep away from direct sunlight or
strong light.
17. Do not exposure to hot or wet air coming from heating installation,
furnace and humidifier.
18. Do not operate this device in environments where there are chemical
materials, dust, and humidity.

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 Operator Manual of Infusion Pump HX-801E

Chapter 2 Introduction

2.1 Application
HX-801E infusion pump is intended to provide accurate and continuous
intravenous infusion.

2.2 Specifications

Product name: Infusion pump

Model: HX-801E
Applicable IV set: 10, 15, 20 and 60 d/mL
(with outer diameter 3.4 ~ 4.5mm)
Pumping mechanism: Peristaltic finger pump
Infusion mode: Drip-rate & volumetric
Maximum flow rate: 1200 mL/h
Drip rate accuracy: ±1.5%
Flow rate accuracy: ±5% (after calibration)
Volume infused display: 0 ~ 9999 mL & >9999 mL
Volume limit: 1 ~ 9999 mL
KVO (keep vein open): 1 mL
Drip detection: Infrared optoelectronic detection
Air-in-line detection: Ultrasonic, 50 ~ 1000 µL, 8 sensitivities setting
Occlusion pressure: 40 ~ 140 KPa, 8 sensitivities setting
Sound volume: 8 levels setting
Max. power consumption: ≤25VA
Peristaltic finger pump: Detachable
Tube clamp: Detachable
Display: Blue LCD with high brightness
AC power: AC100V ~ 240V, 50Hz/60Hz

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 Operator Manual of Infusion Pump HX-801E

Internal battery: Rechargeable Ni-MH battery, DC12V,

2000mAh, life: approximately 4 hours at 25mL/h
Net weight: 2.3 kg
Dimensions: 150mm x 150mm x 235mm
Audio and visual alarms: Air-in-line, Door open, Upstream occlusion,
Downstream occlusion, Infusion finished, No operation, Leakage, Bottom
empty, Battery low, Pump error, Motor reverse, AC power lost, etc.

2.3 Working conditions

Temperature: +5°C ~ +40°C
Relative Humidity: 20% ~ 90%
Atmospheric Pressure: 70KPa ~ 106KPa

2.4 Compliance

Compliance with Medical Device Directive 93/42 EEC.

: Please read the operator manual prior to using this device!
: Protection against leakage current: Type CF equipment.
: Protection against splashing fluid.

2.5 Features
1. HX-801E is with a full function of audio and visual alarm and exact
infusion-controlled function. It is used widely, safely and reliably.
2. HX-801E can control the flow rate automatically. It is not just available
for the intravenous infusion of normal brine and dextrose, but also for
the infusion of high surface tension.
3. Standard IV sets of 10, 15, 20 and 60 d/mL are applicable.
4. The battery supply system can guarantee the continue infusion when
move the patient or the AC power is disconnected.

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 Operator Manual of Infusion Pump HX-801E

5. Easy switch between mL/h, d/min and volume/time units.

6. The finger pump is detachable and can be washed in water.
7. The tube clamp is detachable and can be washed in water.
8. Easily operate with single hand by using the side handle.

2.6 Components and functions

HX-801E is made of housing, peristaltic finger pump, drip sensor, air sensor,
display and battery, etc.

LCD: All essential Handle for

information is carrying
displayed.

Alarm light:
Side handle: Easy Lights up during an
operate with single alarm.
hand.
Pump door
handle: Pull it to
open the door.
Keyboard: Allow
data entry.
Pump door

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 Operator Manual of Infusion Pump HX-801E

Occlusion
pressure sensor
on top

Fluid path Peristaltic finger

pump

Occlusion Air sensor

pressure sensor
at bottom

Tube clamp

Knob: For placing Knob: To attach

drip sensor. the pump to an
IV pole.

Label: To show
the product Drip sensor socket
information.

AC Power socket

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 Operator Manual of Infusion Pump HX-801E

LCD information
Sound icon indicates sound on or off
Battery level
indicator

Remaining volume In-progress

to be infused flow indicator

Remaining infusion Total infused

time volume
Flow rate: d/min and
mL/h units available.
Pressure status
dynamically display
Infusion mode:
Drip-rate or Volumetric. IV set brand and type

Keyboard
Exit key: To return to
Menu key: To the previous menu.
enter the menu or
return to the main Alarm silence key:
screen.
Silence alarm for 2
minutes.
Start/Stop keys
Switch key: To shift
Clear key: To clear the cursor.
the alarm or
parameter. Set/Enter keys: To
activate and confirm
Up/Down keys: To the parameter.
plus or minus the
number and choose Prime key Power key : Battery indicator
the character. light
: AC power
indicator light

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 Operator Manual of Infusion Pump HX-801E

Chapter 3 Operation Guidance

3.1 Operation flowchart
Infusion Pump Installation
↓
IV set Installation
↓
Programmation
↓
Priming
↓
Connect IV Set To Patients
↓
Starting The Infusion

3.2 Infusion pump installation

1. Attach the pump to an IV pole by turning the knob on the back of the
pump clockwise, or place the pump on flat, stable surface.
2. Plug the pump’s power cord into an electrical outlet.
3. Press to turn on the machine, listen for the beep.

Note:
1. The device has a continuous inspection which functions as soon as the pump
is in use.
2. Connect the device to AC power as often as possible to recharge battery.

3.3 IV set installation

1. Close the roller clamp of IV set and insert it into the solution container.
Gently press the drip chamber to fill it up to 1/3 full.

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 Operator Manual of Infusion Pump HX-801E

Turn the roller clamp

此旋钮向左压即可关闭
left to close it

2. Open the roller clamp. Once the IV set is completely primed, close the
roller clamp and check if there is air bubble in the set.
3. Open the pump door. Thread the IV set down the fluid path, making sure
it is threaded the air sensor and pressure sensor. Then open the clamp at
the bottom of the fluid path, insert the IV set and release clamp.
4. Close the pump door and open the roller clamp. Check that no drops are
falling in the drip chamber.
5. Place drip sensor on drip chamber horizontally. It should be lower
than the drip mouth and higher than the liquid surface.
Drip mouth
Keep the drip sensor
Indicator light of horizontally
drip sensor: It will
flash at the same
time when the 1/4 ~ 1/3 full of
solution drips, one drip chamber
flash for one drop. capacity

Note:
1. If volumetric mode is put into use, the device can operate as usual
without drip sensor.
2. Keep the drip chamber straight. If it is sloping, it will be hard to detect
drops or even cause error of infusion and alarm.
3. Keep the drip sensor away from direct sunlight or strong light, or else it
may cause error of infusion and alarm.
4. When there are some drops on the wall of chamber, shake it gently to
clear it in order to avoid miscounting for the drops.
5. If drip sensor disturbed or failed, flow rate abnormal, and IV set
incorrect setting, the device will alarm and stop to infuse, which can
avoid injury from over-flow or under-flow.
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 Operator Manual of Infusion Pump HX-801E

3.4 Infusion parameter setting

3.4.1 Infusion mode setting
1. Press , system will enter into main menu.
2. The cursor positions on “Infusion”, press .
3. The cursor positions on “Infusion Mode”, press to
select the desired mode, drip-rate or volumetric.
4. Return to previous menu by pressing and main screen by pressing .

3.4.2 IV set selection

1. Press , system will enter into main menu.
2. The cursor positions on “Infusion”, press to position the
cursor on “IV Set”.
3. Press to select the brand and size of IV set.
4. Return to previous menu by pressing and main screen by pressing .

3.4.3 Infusion volume setting

Method 1:
1. Press , system will enter into main menu.
2. The cursor positions on “Infusion”, press to position the
cursor on “Volume Limit”.
3. Press to select the desired volume.
4. Return to previous menu by pressing and main screen by pressing .

Method 2:
1. On the main screen, press to enter into “Quick Menu”, the cursor
positions on “Limit”.
2. Press to select the desired volume.
3. Return to main screen by pressing or .

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 Operator Manual of Infusion Pump HX-801E

3.4.4 Infusion rate setting

Method 1:
1. Press , system will enter into main menu.
2. The cursor positions on “Infusion”, press to position the
cursor on “Infuse rate”.
3. Press to select the desired rate.
4. Return to previous menu by pressing and main screen by pressing .

Method 2:
1. On the main screen, press to enter into “Quick Menu”, and press
to position the cursor on “Rate”.
2. Press to select the desired rate.
3. Return to main screen by pressing or .

Infusion rate and volume setting range are as follows:

IV set mL/h d/min Volume limit
10 d/mL 1.0 ~ 1200 1 ~ 200 1 ~ 9999 mL
15 d/mL 1.0 ~ 1200 1 ~ 300 1 ~ 9999 mL
20 d/mL 1.0 ~ 1200 1 ~ 400 1 ~ 9999 mL
60 d/mL 1.0 ~ 1200 1 ~ 150 1 ~ 9999 mL

From 0.1 mL/h to 99.9 mL/h, 0.1 mL increment; ≥100 mL/h, 1 mL increment.

3.4.5 Infusion time setting

It is allowed to set the volume limit and infusion time, then the pump will
calculate the flow rate automatically, detail steps as follow:

1. On the main screen, press to enter into “Quick Menu”, and press
to position the cursor on “Time”.
2. Press to select the desired infusion time.
3. Return to main screen by pressing or .

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 Operator Manual of Infusion Pump HX-801E

3.4.6 Total infused volume

How to clear the total infused volume:

Method 1:
1. Press , system will enter into main menu.
2. The cursor positions on “Infusion”, press to position the
cursor on “Total Volume”.
3. Press to clear the total infused volume.
4. Return to previous menu by pressing and main screen by pressing .

Method 2:
1. On the main screen, press to enter into “Quick Menu”, and press
to position the cursor on “Total”.
2. Press to clear the total infused volume.
3. Return to main screen by pressing or .

3.4.7 Bolus mode

1. Press , system will enter into main menu.
2. Press to enter into “Bolus Mode”.
3. Press to set the desired volume limit.
4. Press to set the desired flow rate.
5. Press to start infusion.

3.5 Priming
1. Check and confirm that the IV set is disconnected to the patient.
2. Press to prime until all the air bubbles are removed.

Note:
The volume of priming will not be cumulated with the total infused volume.

Flow rate for purging: 600 mL/h

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 Operator Manual of Infusion Pump HX-801E

3.6 Start the infusion

1. Connect IV set to patient site and check general installation.
2. Check and make sure all the parameters showed on main screen are correct.
3. Press to start infusion.

Attention: Under drip-rate mode, please check if indicator light of the drip
sensor flashes at the same time when the solution drops.

3.7 Stop infusion

1. At any time, the infusion can be stopped by pressing .
2. To resume the infusion, press .

3.8 Infusion finish

1. When the infused volume reaches the volume limit, the device will give
an audio and visual alarm “Finished. KVO” and infuse at KVO rate.
2. Press to stop infusion.
3. Disconnect IV set from patient site.

3.9 Power off

Stop the infusion and keep pressing until the device turns off.

3.10 System management

3.10.1 Occlusion sensitivity setting
1. Press , system will enter into main menu.
2. Press to enter into “System”.
3. Press to enter into “Pres. -Top” or “Pres. - Bottom”.
4. Press to set the desired sensitivity.

From level 1 to level 8, the pressure limit is increasing.

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 Operator Manual of Infusion Pump HX-801E

The higher the pressure limit, the less sensitive the pump is to changes in
fluid resistance.

Occlusion alarm response time and possible infused volume based on 20 d/mL
IV set:
1 mL/h 25 mL/h Volume
Level 1 28 minutes 01 second 1 minute 18 seconds 0.55 mL
Level 8 59 minutes 2 minute 18 seconds 0.99 mL

3.10.2 Air-in-line sensitivity setting

1. Press , system will enter into main menu.
2. Press to enter into “System”.
3. Press to enter into “Air Sens.”.
4. Press to set the desired sensitivity.

From level 1 to level 8, the threshold for alarm is increasing.

3.10.3 Sound volume setting

1. Press , system will enter into main menu.
2. Press to enter into “System”.
3. Press to enter into “Sound Volume”.
4. Press to set the desired sound volume.

3.11 Unit convert

This function is for operator to convert the infusion rate, if it is known any
of d/min and mL/h, the other will be calculated automatically.

1. Press , system will enter into main menu.

2. Press to enter into “Unit Convert”.
3. Press to input the desired rate, d/min or mL/h.
4. The other rate will be calculated automatically.

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 Operator Manual of Infusion Pump HX-801E

3.12 Manage IV set

3.12.1 Calibration value setting
1. Press , system will enter into main menu.
2. Press to position the cursor on “Manage IV set”.
3. Press to position the cursor on “Edit Adj Value”.
4. Press to select the desired IV brand.
5. Press to position the cursor on the desired size of IV brand.
6. Press to select the desired calibration value.
7. Return to previous menu by pressing and main screen by pressing .

3.12.2 Add new brand of IV set

1. Press , system will enter into main menu.
2. Press to position the cursor on “Manage IV set”.
3. Press to position the cursor on “Add a Brand”.
4. Press to set the brand name.
5. Return to previous menu by pressing and main screen by pressing .

3.12.3 Auto calibration

The accuracy of infusion will be affected by the below factors, therefore
it is necessary to calibrate for each type of IV set before putting into use
in order to ensure the accuracy.

1. Difference of IV set diameters for various brands.

2. Different surface tension of various concentration solutions.

Preparation:
A measurement cup to measure the actual volume of the solution.
A container filled with 200 mL (or above) 0.9% standard physiological brine
or pure water.

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 Operator Manual of Infusion Pump HX-801E

Process:
1. Install and prime the IV set.
2. Press , system will enter into main menu.
3. Press to enter into “Manage IV Set”.
4. Press to enter into “Adjust IV Set”.
5. Press to select the IV brand.
6. Press to select the IV size.
7. Press to input the flow rate.
8. Press to input the volume.
9. Place the end of IV set into measurement cup and start infusion.
10. Once the pump stop running and alarming for finish calibration, it will
ask to input the actual volume infused. Press to
input the volume from the measurement cup.
11. Repeat step 2 to 10, calibrate for another time to ensure the high
accuracy. The calibration process is finished.

Note:
1. The default flow rate and volume for calibration is 50 mL/h and 10 mL
respectively, operator can change them as they want, and it is
recommended to set the volume as 1/5 of the rate.
2. It is recommended to make a record for the calibration result in
order to avoid negligence during the operation.
Here is the example for operator reference.
IV Brand IV Size Calibration Finished?
A 20 d/mL Yes
A 15 d/mL Yes
B 20 d/mL Yes

3.12.4 Calibration by manual

Preparation: The same as auto calibration.

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 Operator Manual of Infusion Pump HX-801E

Process:
1. Install and prime the IV set
2. Set the volume limit as 10 mL according to section 3.4.3.
3. Set the flow rate as 50 mL/h according to section 3.4.4.
4. Clear the total infused volume according to section 3.4.6.
5. Place the end of IV set into measurement cup and start infusion.
6. Once volume limit is finished, measure the actual volume in the cup,
and calculate the calibration value (Value A) by the below formula.
Calibration value Total infused volume – Actual Volume
= x 100%
(Value A) Actual Volume

7. Input Value A into the pump according to section 3.12.1. The calibration
process is finished.

Note:
The calibration value should be -30% ~ +30%, or else it means some
mistakes occur during infusion, and it needs to re-perform the calibration.

3.12.5 Adjust calibration value for high concentration solution

It should be add a calibration value (Value B) for the high concentration
solutions showed in the below form, since its high surface tension will
affect the accuracy.
Note: If it is already used the corresponding high concentration solution for
calibration, it is not necessary to add Value B.

Solutions Calibration values (Value B)

Common solution 0%
Dextrose (10%) +5%
Dextrose (50%) +10%
TPN(Total Parental Nutrition) +5 ~ +10%
TPN+ fat-soluble vitamin +10 ~ +20%

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 Operator Manual of Infusion Pump HX-801E

1. If it is already calibrated by auto calibration based on section 3.12.3,

input Value B directly to the device according to section 3.12.1.
2. If it is calibrated by manual based on section 3.12.4, input total
calibration value to the device as below according to section 3.12.1.
Total calibration value = Value A + Value B

3.12.6 Delete a brand of IV set

1. Press , system will enter into main menu.
2. Press to position the cursor on “Manage IV Set”.
3. Press to position the cursor on “Delete a Brand”.
4. Press to select the IV brand.
5. Press to confirm, or to return to previous menu.

3.13 Others
3.13.1 Change of container
1. Press to hold infusion.
2. Close roller clamp.
3. Disconnect set from the old container.
4. Connect set to new container according to good clinical practices.
5. Check fluid level in drip chamber (around 1/3 of its capacity).
6. Program new infusion parameters: flow rate, volume, …
7. Open roller clamp.
8. Press to start infusion.

3.14 Alarms and errors

3.14.1 Alarms
When the alarm occurs, it is with visual and audio signal. The audio signal
can be switched off for 2 minutes by pressing . To clear the alarm,
press .

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 Operator Manual of Infusion Pump HX-801E

Alarms Possible cause Actions

Door open Door is open. Close the door.
Infusion finished. 1. Change solution container and
Finish! KVO restart infusion.
2. Remove IV set.
IV set is not installed or Install the IV set properly and make
IV set is installed sure it thread the air sensor.
incorrectly.
Air in line
Air bubble in the IV set. Remove air from IV set.
Air inlet cap is closed. Check where the air inlet is open
and make sure it is not blocked.
IV set kinked. Correct kinks.
Upstream
Air inlet cap is closed. Check where the air inlet is open
occl.
and make sure it is not blocked.
(occlusion)
Bottle empty. Check solution container.
IV set kinked. Correct kinks.
Roller clamp closed. Open roller clamp.
Downstream
occl. Needle blocked. Check if the needle is blocked.
(occlusion) IV set is too hard or its Change another IV set or increase
diameter exceeds the the occlusion pressure limit.
acceptable limit.
No operation for 2 Press or .
No operation
minutes.
The bottle is empty. Replace solution container.
Upstream occlusion. Refer to upstream occlusion alarm.
Too much fog on wall Shake drip chamber.
Bottle empty of drip chamber.
Solution is flowing Reposition drip chamber.
through the wall but
not dripping due to
sloped drip chamber.

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 Operator Manual of Infusion Pump HX-801E

Alarms Possible cause Actions

Parameter err! Infusion parameter Check and reset parameter.
(Error) incorrect.
IV set is installed Reinstall it.
incorrectly.
Leakage
Drip sensor is violently Keep drip sensor stable.
disturbed or shaken.
Drip Sens. lost Drip sensor is lost. Connect drip sensor to the pump.
Drip sensor is not Place drip chamber properly.
properly placed on drip
Drop detect err! chamber.
Drip chamber is over Lower the fluid level.
filled.
Drip sensor err! Drip sensor is damaged. Change a drip sensor.
Battery low Battery voltage is low. Connect pump to AC power.
Battery ran out Battery is nearly used up. Connect pump to AC power.
Battery disconnected. Connect battery properly.
Battery lost
Battery damaged. Change another battery.
AC power lost AC power is lost. Connect pump to AC power.
Top / Bottom Top / Bottom pressure Stop using the device and contact
pressure sensor is not working with after-sales service.
sensor error properly.
Air sensor Air sensor is not Stop using the device and contact
error working properly. with after-sales service.
Pump is blocked due to Clean the pump.
serious pollution.
Pump error Pump is blocked due to Reinstall the IV set.
improperly installation
of IV set.
Motor is running Stop using the device and contact
Motor reverse
reversely. with after-sales service.
Stop using the device and contact
System failed Internal error.
with after-sales service.

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 Operator Manual of Infusion Pump HX-801E

Note: The possible infused volume in a single failure is less than 0.7 mL.

3.14.2 Other errors

Check as follows firstly by yourself before contact with after-sales service:

Phenomena Possible Cause Actions

The device can not be Are AC power and Connect the AC power and
turned on. battery properly battery properly.
connected?
Can not infuse, strange Is there anything Clean the finger pump cassette.
sound emitted from stuck on the finger
finger pump cassette. pump cassette?

3.15 Daily check

Checking points Procedures
Check if the housing is
flawed, cracked or Check the housing of the device.
distorted.
Check if the power cord
Check the power cord.
is damaged
Check finger pump Open pump door and take away the finger pump cassette.
cassette. Rotate gear and check if it revolves smoothly.
Before installing the IV set, the pump will alarm for “Air
Check air sensor.
in line” when start infusion.
Check door sensor. Open the door, the pump will alarm for “Door open”.
Note: If any problem can’t be solved by operator, please stop to use and contact
with after-sales service.

Chapter 4 Maintenance
4.1 Daily Maintenance
Disconnect the AC power cord before cleaning the device.

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 Operator Manual of Infusion Pump HX-801E

EOG sterilization; Ultrasonic sterilization

Attention: Do not wash the device by diluents, alcohol and other organic liquid.

4.1.1 Clean the housing

Clean the pump with a soft lint-free cloth or swab dampened with detergent and
water.

4.1.2 Clean the air sensor

Gently wipe the sensor surface with wet cotton, and dry it well.
Do not damage the sensor surface.

4.1.3 Clean the finger pump cassette

Take away the finger pump cassette and wash it,
then wipe with dry cotton and install.

4.1.4 Clean the tube clamp

1. Loosen screw and remove the tube clamp.
2. Wash the tube clamp.
3. Dry it well with dry cotton and install it.

4.1.5 Clean the drip sensor

1. Wipe the drip sensor with wet cotton.
2. Dry it with dry cotton and install it.

4.2 Battery
4.2.1 General guidance
1. When AC power disconnected, the pump will alarm and be powered by
internal battery, user can press to silence the alarm.
2. To recharge battery, just connect the device to AC power supply. Recharging
of the battery is visualized by the indicator when the pump is turned off
and when the pump is turned on.
3. The device will alarm when the battery is low, then stop infusion about 27

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 Operator Manual of Infusion Pump HX-801E

minutes later and turn off about 30 minutes later automatically.

4. Charge battery on initial use approximate 16 hours.
After several times of charging and consuming process, the maximum
battery capacity can be achieved.
If the charging and consuming cyclic process keeps increasing and the
battery is charged repeatedly without full discharge, the battery capacity will
decrease concomitantly. If the device will not be put into used for long time,
it is suggested that the internal battery is used every half year.

Note: Deal with the wastes (batteries, electrical and electronic device) according
to the local regulations, and try to make the wastes recovered. The wastes can
not be handled as daily garbage.

4.2.2 Replace battery

1. Loosen screw to remove battery cover at the bottom of the device.
2. Disconnect the battery and move it out.
3. Place and connect new battery, then install the cover.

Note:
1. Do not place the battery close to fire or heat source.
2. Use the specified battery provided by the manufacturer only.

4.3 Periodical replacement for accessories

The following accessories should be replaced periodically.

Accessories Recommended replacement period

Battery 2 years
Finger pump cassette 3 years
The warranty for the battery is one year.

4.4 Transportation and storage conditions

Temperature: -20°C ~ +55°C
Relative Humidity: 10% ~ 90%
Atmospheric Pressure: 70KPa ~ 106KPa

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 Operator Manual of Infusion Pump HX-801E

Chapter 5 Appendix
5.1 Trumpet curve
Trumpet curve indicates the trend of the max and min deviations of the infusion pump. The detection
proposals introduced for obtaining results in this aspect are based on EN60601-2-24. For more
detailed information, please refer to this publication.
The following curve represents the results after using Hanahao IV set in the test; and it is considered
as only one basis of the overall performance of the infusion pump. For more related information,
contact the supplier.

Percentage error
of drops
（1, 100）
100
80
60
Ep(max) set drip rate r = 1 drip/min
40 （5, 20）
（11, 9.090） （19, 10.5263） （31, 6.4516）
20
A
0
（11, -9.090） （19, -5.2632） （31, -3.2258）
-20
Ep(min)
-40
（5, -40）
-60
-80

-100
0（1, -100） 5 10 15 20 25 30 35
observation window(min)

Figure2- Trumpet curve plotted from data gathered dring the

second hour of the test period

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 Operator Manual of Infusion Pump HX-801E

Percentage error
of drops
(1, 100)
100

80
60 (2, 50)
(5, 40) Ep(max) set drip rate r = 1 drip/min
40
(11, 18.1818)
20 B (19, 10.5263) (31, 6.4516)
0
(31, -3.2258)
-20 (19, -10.5263)
(5, -20) (11, -18.1818)
-40 Ep(min)
(2, -50)
-60
-80
-100
(1, -100)
0 5 10 15 20 25 30 35
observation window (min)
Figure3-trumpet curve plotted from data gathered during the last hour of the
ADMINISTRATION CHANGE INTERVAL

5.2 Guidance and manufacturer’s statement on

anti-electromagnetic interference Ⅰ
Applicable to all the devices and systems
1 Guidance and manufacturer’s statement on anti-electromagnetic interference
This device is predicted to be used in following electromagnetic environment. The buyer or user
2
of the device should make sure to use it in this electromagnetic environment.
3 Emissions test Compliance Guidelines on the electromagnetic environment
RF energy of this device is only applicable to the
inner part. Therefore, its RF emissions are very low
4 RF emissions CLSPR 11 Group 1
and are not likely to cause any interference in nearby
electronic equipment.
5 RF emissions CISPR 11 Class B
Harmonic current
6 Class A
IEC 61000-3-2
Voltage fluctuation and
7 Complies
flicker IEC 61000-3-3

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 Operator Manual of Infusion Pump HX-801E

Guidance and manufacturer’s statement on anti-electromagnetic interference

This device is predicted to be used in following electromagnetic environment. The buyer or user of the
device should make sure to use it in this electromagnetic environment.
Immunity Test IEC 60601 Compliance Level Guidelines on the
Test Level electromagnetic environment
Electrostatic ±8kV Contact ±8kV Contact The ground should be made of
discharge (ESD) ±15kV Air ±15kV Air wood, concrete, or ceramic. If
IEC 61000-4-2 the ground is covered by
composite materials, the RH of
the air should be not lower
than 30%.
Electrical fast ±2kV Power cord ±2kV Power cord Mains power quality should be
Transient burst ±1kV Input/output ±1kV Input/output that of a typical domestic,
IEC61000-4-4 commercial or hospital
environment.
Surge ±1kV Differential mode ±1kV Differential mode Mains power quality should be
IEC 61000-4-5 ±2kV Common mode ±2kV Common mode that of a typical domestic,
commercial or hospital
environment.
Voltage dips, <5%Ut <5%Ut Mains power quality should be
Short (>95% dips in Ut) (>95% dips in Ut) that of a typical domestic,
interruptions and 0.5 cycle 0.5 cycle commercial or hospital
voltage 40% Ut 40% Ut environment.
variations (60% dips in Ut) (60% dips in Ut) If the users need to continue
IEC 61000-4-11 5 cycle 5 cycle the operation during power
70% Ut 70% Ut failure; therefore, the
(30% dips in Ut) (30% dips in Ut) uninterruptible power supply
25 cycle 25 cycle or battery power supply are
<5% Ut <5% Ut recommended.
(>95% dips in Ut) (>95% dips in Ut)
5 seconds 5 seconds
Power frequency 3 A/m 3A/m Electric power frequency
(50/60Hz) magnetic fields should comply
Magnetic field with the standards of the
IEC 61000-4-8 commercial or hospital usage.
Note Ut is the AC mains voltage prior to application of test level.

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 Operator Manual of Infusion Pump HX-801E

5.2 Guidance and manufacturer’s statement on

anti-electromagnetic interference Ⅱ

Guidance and manufacturer’s statement on anti-electromagnetic interference:

applicable to all the non-living device and systems
This device is predicted to be used in following electromagnetic environment. The buyer or user
of the device should make sure to use it in this electromagnetic environment.
Immunity IEC 60601 Compliance Electromagnetic environment guidelines
test test level level
Conducted 3Vrms Portable and mobile RF communications device should not
RF IEC 150KHz 3V be placed closer to any parts of the device than the
61000-4-6 to 80 MHz recommended separation distance. The separation distance
should be calculated by the formula corresponding to the
transmitter frequency.
Recommended Separation Distance
Radiation,
RF, 3V/m
electromag 80MHz 3V/m 80MHz to 800 MHz
netic field to 2.5 GHz
IEC 800MHz to 2.5 GHz
61000-4-3 If p is the maximum rated output power (w) provided by the
RF device manufacturers, d will be the recommended
separation distance (m). (b)
The field strength of fixed RF transmitters is determined by
the investigation of the electromagnetic fields. Each band
should be lower than compliance level. (a) (b)
Device marked with the following tag would interfere with

the nearby substances:

Note 1. If the frequency of the communications device is 800MHz or higher, formula for the high band
should be used.
Note 2. The proposed guidelines may not be applicable to all conditions. Electromagnetic spread can be
affected by absorption and reflection of buildings, substances, and human bodies.
a) Field strength of the fixed transmitters (such as Wireless (cordless / cellular) telephones and ground
mobile radio station, amateur radio, AM FM radio and television broadcasting) can not be predicted
theoretically.
In order to evaluate the electromagnetic environment of the fixed RF transmitters, the investigation of
electromagnetic field should be taken into consideration. If the field strength of the place near to the
device is higher than the RF compliance level, the pump should be observed and checked to assure
whether it can work normally. If abnormal performance is observed, the compensation measures may be
necessary, for example, re-orientate and re-position the device.
b) When the frequency range is between 150kHz and 80MHz, the field strength should be less than
3V/m.

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 Operator Manual of Infusion Pump HX-801E

Maximum rated output power of Separation distance determined by the frequency of the
the communications device (W) communications device (m)
150KHz to 80MHz to 800 MHz to
80MHz 800MHz 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For the maximum rated output power of the transmitter not listed in the above table, the
recommended separation distance d (unit: m) can be determined by the formula in the corresponding
column of the transmitter frequency. Here, p is the maximum rated output power rating provided by
the manufacturer (unit: w).
Note 1. If the frequency of the communications device is above 80MHz-800MHz, the formula for
high brand should be applied.
Note 2. The proposed guidelines may not be applicable to all conditions. Electromagnetic spread
can be affected by absorption and reflection of buildings, substances, and human bodies.
Recommended separation distance between portable / mobile RF communications device and
syringe pumps
This device is expected to be used in the electromagnetic environment where the radiation RF
disturbance is controlled. Based on the maximum output power of the communication device, the
buyers or users can prevent electromagnetic interference through maintaining the minimum
distance between the portable/mobile RF communications device (transmitters) and the infusion
pump.

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 Operator Manual of Infusion Pump HX-801E

Keep your patients safer

Make your job easier!

Guangzhou Huaxi
Medical Science Technology Co., Ltd.
6F, Building A8, No.11, Kaiyuan
Avenue, Science City, Guangzhou
Hi-tech Industrial Developments Zone,
Guangzhou. China.
Tel: 0086-20-32290298, 32290268
Fax: 0086-20-32053080
Postal code: 510530
Website: http://www.gzhuaxi.com