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INFUSION PUMP WIT-601A

User Manual

Guangzhou WIT Medical Technology Co., Ltd

Version: 3.0
CONTENTS
Introduction............................................................................................................................................................... - 3 -
Safety Tips................................................................................................................................................................. - 3 -
Chapter 1 Overview................................................................................................................................................- 5 -
1.1 Scope of application.................................................................................................................................... - 5 -
1.2 Technical Parameters...................................................................................................................................- 5 -
Chapter 2 Components description........................................................................................................................ - 7 -
Exterior components names description........................................................................................................... - 7 -
Infusion tube parts description.......................................................................................................................... - 7 -
Main information displayed on LCD................................................................................................................ - 8 -
Infusion pump structure.................................................................................................................................... - 9 -
Chapter 3 Assembling
Packing list...................................................................................................................................................... - 10 -
Pump Installation.............................................................................................................................................- 10 -
IV Set Installation............................................................................................................................................- 13 -
Chapter 4 Operation............................................................................................................................................. - 14 -
Function key description................................................................................................................................. - 14 -
Operation Flowchart........................................................................................................................................- 15 -
Volume mode operation...................................................................................................................................- 16 -
VTBI/Rate/Time..............................................................................................................................................- 16 -
Rate/Time........................................................................................................................................................ - 17 -
Simple Rate..................................................................................................................................................... - 17 -
Program mode................................................................................................................................................. - 18 -
Dose/weight mode...........................................................................................................................................- 20 -
Drug library mode........................................................................................................................................... - 21 -
Chapter 5 Special functions..................................................................................................................................- 23 -
Bolus................................................................................................................................................................- 23 -
Auto Bolus.......................................................................................................................................................- 23 -
Manual Bolus.................................................................................................................................................. - 23 -
IV set management.......................................................................................................................................... - 24 -
Add IV set........................................................................................................................................................- 27 -
Remove IV Set................................................................................................................................................ - 28 -
Chapter 6 General operation................................................................................................................................ - 29 -
Stop..................................................................................................................................................................- 29 -
Power off......................................................................................................................................................... - 29 -
Standby............................................................................................................................................................ - 29 -
(Piggyback)..................................................................................................................................................... - 29 -
Purge................................................................................................................................................................- 29 -
Mute.................................................................................................................................................................- 29 -
Clear alarm...................................................................................................................................................... - 29 -
Clear the VI..................................................................................................................................................... - 30 -
Battery life check.............................................................................................................................................- 30 -
Setting fluid warmer........................................................................................................................................- 30 -
Pre-alarm setting of infusion completion........................................................................................................- 30 -
Bottom occlusion pre-alarm setup.................................................................................................................. - 30 -
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key lock (auto).................................................................................................................................................- 30 -
key lock (manual)............................................................................................................................................- 30 -
Chapter 7 History record check............................................................................................................................- 33 -
Check history records in machine................................................................................................................... - 33 -
Export history record.......................................................................................................................................- 33 -
Chapter 8 Security characteristic and alarm........................................................................................................ - 34 -
Trouble shooting..............................................................................................................................................- 34 -
Chapter 9 Routine check...................................................................................................................................... - 37 -
Chapter 10 Electrical specification...................................................................................................................... - 38 -
Chapter 11 Storage and transport......................................................................................................................... - 39 -
User's Guide and Manufacturer’s Statement of Anti-electromagnetic Interference I............................ - 40 -
User’s guide and manufacturer’s statement of anti-electromagnetic interference II............................. - 41 -
Infusion accuracy characteristic..............................................................................................................- 43 -
System statement.....................................................................................................................................- 44 -
Product and service information............................................................................................................................. - 45 -

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Introduction
Thank you for choosing WIT-601A Infusion Pump. Please carefully read and understand this manual before
use. Regularly check and maintain the pump to avoid possible injury or risks.

Safety Tips
1. WIT-601A Infusion Pump is not explosion proof type or portable device.
2. WIT-601A Infusion Pump cannot be used in the condition with mixed gases of flammable anesthetic
gases, oxygen, or ammonia.
3. WIT-601A Infusion Pump can only be used by professional. Patients are not allowed to use.
4. Prevent patients from excessive or insufficient flow induced injury by the following methods: set
infusion parameters correctly, use the calibrated infusion device.
5. If there is any anomaly, suspend using should be taken as the preferred safety measure.
6. To avoid malfunction, keep the device away from strong electromagnetic source or noise when using,
such as NMR equipment, microwave generating devices, radiation equipment (X-ray, CT, etc).
7. To avoid malfunction, keep this device away from the high-frequency surgical instruments (such as
rack, cable, electrode feeder plates, etc.), the distance should be at least 25cm; at least 1m away from
the cell phone.
8. Do not use other voltages. Only use the specified voltages on nameplate of WIT-601A Infusion Pump,
or may cause damage or fire.
9. Do not throw batteries into fire or heat them, otherwise it will result in electrolyte leakage, fire, or
explosion.
10. Do not tear up the shell of batteries; otherwise it will cause an explosion or chemical burn hazard.
11. When plugging or unplugging the AC power, grip the plug firmly. Do not touch it with wet hands.
12. It is not recommended to share an outlet with other electrical equipments.
13. Never disassemble or modify the device arbitrarily.
14. Check the device daily. If not used for a long time, be sure that the functions are normal before
re-use.
15. If any anomaly or function loss, discontinue use and contact the supplier in a timely manner.
Otherwise the user shall take sole responsibility for any consequences.
16. Avoid vibration, bumps, direct sunlight or strong light.
17. Avoid direct contact with blowing hot, wet air from heating, electric stove or humidifier.
18. Avoid using the device in the following places: chemical storage place, dusty place,
vibration/shaking and damp places.
19. WIT-601A Series Infusion pump is class I in electrical safety classification. When in doubt in wiring
the protective earth conductor, it must be operated by the internal power supply.
20. WIT-601A Series syringe pump cannot be used in parallel with other brands of pumps.
21. The alarm sound pressure range of WIT-601A Series pump is 47-71 db, and the noise in the
operating environment cannot exceed 60 db.
22. Strictly in accordance with User’s Manual of infusion pump in use and maintenance.
23. Infusion pump using infrared drop sensor, does not apply to dark infusion tubing.
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24 The infusion pump is apply to 20d/ml, 60d/ml tubing, if the tubing type was set in Abnormal, there is
a big risk of accuracy deviation. Please make sure the tubing type settings are correct!
25. If not be adjusted based on different tubing type and different drug liquid, it may cause large
deviations in infusion accuracy.
26. if alarms are presented, the related medical personnel should be take the related solutions in time
and restart the infusion pump.
27. In clinical use, what kind of drugs can be used for heating fluids, how many degrees Celsius in
temperature should be rise, you must consult your doctor and strictly follow the doctor's advice

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Chapter 1 Overview

1.1 Scope of application

It is applicable to accurate, constant and continuous intravenous infusion in medical institutions.

1.2 Technical Parameters

IV Set Options /Size: Open System for common widely-used brand of 10d/ml、15d/ml、20d/ml、60d/ml

(3.4mm~4.5mm), Also can be customized for dedicated IV set

Function Option With Drug Lab. Without Drug Lab.


Built-in 500 kinds of drugs, covering
the clinical use of the drug dose of 54
Drug Lab. units on the library, and could be NONE
connect with the PC for edit; export
& import.

Rate/VTBI、Time/VTBI、Rate/Time、Volume、Drop、Micro、Simple Rate、
Working Mode
Programmable、DOSE Weight、Drug Lab、Auto Bolus、Manual Bolus.

IV Set Open System for 10d/ml、15d/ml、20d/ml、60d/ml (3.4mm - 4.5mm)


IV Set management could add / remove / edit more than 40 kinds tubes

Accuracy Volume Mode:≤ ±5%,Drop Mode:≤ ±2% (after calibrate)

Calibrate Automatic or manual calibration of infusion accuracy


Volume:0.1ml/h~1200ml/h Purge:600ml/h
Rate
Drop:1d/min~400d/min
VTBI 1~9999 ml or OFF
Total Volume Σ 0~9999.9 ml
KVO 1ml/h~5ml/h Adjustable,Default:1ml/h
Programmable Maximum 8 steps of different infuse rate / time / VTBI
Manual Bolus:long Press the Bolus key to infuse and release to stop
BOLUS
Auto Bolus:short press the Bolus key and set the VTBI & Rate

Upper Pressure High / Middle / Low, 3 level, could off on the menu.

Down Pressure 200mmHg - 1200mmHg, 20 level, live pressure display, mmHg & kPa two units

Pre-Alarm Occlusion When the pressure in the tube goes up, it has the function of early warning
Pre-Alarm Finish 1 min~30 min, The alarm can be set ahead of VTBI
changes the Rate, Time, Dose, VTBI & other important parameters during the infuse
Parameters Modify
working
Keypad Locker Manual / Auto lock keyboard
History Record Record 20000 infuse records, 10000 alarm records, can be downloaded to the computer

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to save & query
Self-Test safety real time self-test function to ensure the pump working properly

Bubble Detected by ultrasonic sensor with adjust setting 5 level, 50μL ~ 800μL,
Infrared sensor to detect the number of drops, monitoring the status in case the empty
Drop Sensor
bottles
Bubble, Door open, Finish, Pause timeout, Down Occlusion, Up Occlusion, Lower
Alarm Battery or damage, Motor error, Incorrect IV Set-type, Pressure test failure, Motor
failure, Abnormal drop rate, Heater failure and etc. 30 kinds safety monitoring alarm
3 color light tips:Green for infuse working;Orange for low level alarm (counting
Light Tips
working);Red for high level alarm (pump stop).
Compliance YY 0709-2009 medical standard, Alarm and key volume level adjustable,
Voice Tips
with Mute function,

Monitor High brightness color LCD, Adjustable brightness

Communication RS485 port, connect with PC to update / download


AC Power AC100V~240V,50Hz/60Hz,25VA
Ni-MH battery, DC9.6V, 2000mAh (after full charged, could continue work more than
Battery
5 hours by 25ml/h rate)
Battery power query Live-time query battery life and battery charge status

Class Class IIb, Type CF, IPX4

Installation For round and square pole,Horizontal / Vertical

Dimension 2.0kg , 130mm×120mm×195mm

Environment 5℃~40℃; 20%~90% humidity; 70kPa~106kpa atmospheric

Use Range For the patients with constant intravenous infusion of drugs

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Chapter 2 Components description

Exterior components names description

Handle

LCD

Fluid warmer

Key
Drop sensor

Door latch

Infusion tube parts description

Infusion set guide slot

Up pressure

Bubble sensor

Peristaltic pump

Roller clamp

Bottom pressure sensor

Infusion set guide slot

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Main information displayed on LCD

Battery status Working status

Machine status bar


Keypad lock status
Infusion set info

AC status

Flow rate
Sound status

Infusion status

VTBI
Pressure status
Time needed

Volume infused

(1) Machine status bar: battery status icon, sound status icon, networking status icon, AC supply status
icon, infusion status icon, pressure status icon, IV Set brand, specification, and fluid warmer
temperature.
(2) Infusion parameter.

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Infusion pump structure

Figure 4

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 Chapter 3 Assembling
Packing list
Please check the follow contents when unpacking:
(1) Infusion pump body……………………………... 1 set
(2) Drop sensor……………………………………… 1 set
(3) Power cord……………………………………… 1 set
(4) User’s manual………………………………….. 1 copy

 Pump Installation
Horizontal installation on bracket

Figure 5

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Vertical installation on bracket

Installation on cylinder

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Installation on square tube

Tips: infusion pump can be placed and used on a flat top, such as bedside cabinet top; do not move a working
pump.

 Infusion pump socket description


(1) Plug the corresponding plugs into the rear sockets of WIT-601 series infusion pump according to the
icon shown on pump back.

Notes: if the drop sensor is not connected, “drop sensor failure will
alarm.

(2) If not use the drop sensor, can clamp the sensor on the locking
handle.

Notes: the drop sensor should be placed stably to avoid the risk of damage when movement,
transportation and storage.
Drop sensor Network
AC socket
socket socket

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 IV Set Installation
(1) Under normal conditions, insert an ordinary PVC
IV set into the outlet of infusion bottle/bag.
(2) Slightly squeeze Murphy’s dropper with fingers, to
make its 1/3 volume fill with liquid (see figure 9)

Notes:To ensure normal drip, never fill the dropper with water,
otherwise the infusion pump cannot detect drip drops and will cause
alarm; if the volume is less than 1/4, the bubble will easily go into
the infusion tube and cause bubble alarm.

Notes: Please make sure that the air filter and inlet tube of infusion bottle/bag are smooth, otherwise it may

cause vacuum inside, then up occlusion happens, and prompt alarm.

 Purge the air inside the infusion tube, make sure


no bubble inside, then close the adjustable clamp
of ordinary PVC set to prevent loss of liquid.
 Open the infusion pump door, turn the locking
clamp (F) to the left to put the infusion tube.
Put the infusion set into guide slot A between
the liquid bottle/bag and the device.
 Put the infusion tube into the guide slots B,C,D,E,
F, G and H vertically, so that the infusion tube can
be a straight line, as shown in figure 10.
 Close the pump door tightly, then open the
infusion set adjustable clamp.

Notes:1. Make sure the infusion tube is put into the


bottom of ultrasonic sensor (guide slot C),
otherwise bubble alarm would happen.
2. Make sure no liquid drips in the Murphy’s dropper this moment (i.e. no leakage).

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Chapter 4 Operation

 Function key description

Function keys concentrate upon the front housing, operated easily, the functions are as follows:

Function key Description


On/Off Used for boot and shutdown, long press for 1 second to boot, and long press 1 second to shut
down on the condition of no infusion.
Mute Used when alarm happens, press it, the top left indicator of Mute lights up, and then the mute
status will last 2 minutes. Meanwhile it has mute key function, lasts 2 minutes.
Purge/BOLUS On the condition of pause, long press to purge air inside tube; in process of infusion, press it
to enter BOLUS setting interface, then can start BOLUS infusion after setting parameters.
CFM/Set Used to confirm and save the items chose. In the menu, press it to enter next level menu.
Press it in process of infusion, can reset infusion rate.
Menu/Exit On the condition of pause, press it to enter the menu for parameter setting; and press it to
return to the previous menu; on the condition of standby, press it to exit the standby.
Start/Stop Press it to start infusion on the condition of pause; and press it to stop infusion in process of
infusion.

Clear On the condition of alarm, press it to cancel the sound-light alarm; on the condition of
inputting parameters, press it to set parameters to 0.

Lock/Dot In process of infusion, long press for 1 second to lock or unlock. On the condition of pause,
long press to enter standby status.
Up Used to move the cursor upwards.

Down Used to move the cursor downwards.

AC Used to indicate AC power connection.


indicator

Figure 11

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 Operation Flowchart

Infusion operational processes

Pump installation

Power on

IV Set installation

Parameters setting

Purge bubbles

Venous puncture

Start infusion

Power On
 Connect the power wire, then the light indicator lights up, the AC power is connected, long
press the power button for 3 seconds to start up.
 Machine launches self-check after starting up, the contents of self-check include: whether the
batteries is normal, whether the system is normal, whether the pressure sensor is normal, etc., after
self-check completed, machine would enter infusion standby interface, waiting for user to input
infusion parameters.

Notes: Not connect the AC power supply or the AC power is interrupted, machine would switch to battery
power supply automatically, infusion pump would prompt AC falls off; working on the condition of
battery power supply, pay attention to the risks of battery power off, so please connect the AC power
supply as soon as possible.

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Volume mode operation
 Infusion mode selection

 Press in stop, display infusion mode interface. If the present mode is volume mode, so not need to
select mode.
 Choose “volume mode” with up or down key.
 Press , then return to infusion interface after volume mode is chosen.

VTBI/Rate/Time

 Move the cursor to corresponding input boxes of rate, VTBI and time with the up or down key.
 Set rate.
 Set VTBI
 Set time. (if need)
 Press
Notes: set every two of these three parameters, the rest one will be calculated automatically, the machine would
calculate another parameter with the two last input parameters. And infusion would begin according to the
two last input parameters.

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Rate/Time

 Move the cursor to corresponding input boxes of rate and time with the up or down key.
 Set rate.
 Set time.
 Press .

Simple Rate

 Move the cursor to VTBI input box with the up or down key, long press for 1 seconds. The VTBI value
would be displayed “OFF”.
 Set rate.
 Press .
Notes: 1. Choose simple infusion mode, should first move the cursor to VTBI input box with the up or down
key, long press for 1 seconds. The VTBI value would be displayed “OFF”. Press any numeric
key (0-9), “OFF” would disappear, exit the simple infusion mode.
2. Drop sensor plays a role in monitoring during simple infusion mode, it would prompt the alarm of
empty when detecting no liquid drips.

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Program mode
Custom can himself define 8 stages of program mode to infuse automatically. Allow to suspend
programming in process of infusion, but KVO would be launched during programming pause. If the rate of
previous program is less than 1ml/h, then the KVO begins according to the rate of previous program; if the
rate of previous program is greater than 1ml/h, then the KVO begins according to the rate of 1ml/h.

 Infusion mode selection

 Press in starting up status, display infusion mode interface.


 Choose “program mode” with up or down keys.
 Press to enter program mode interface.

 VTBI/Rate Setting

Programming interface Preview interface Infusion interface


 Move the cursor to corresponding input boxes of VTBI and rate with the up or down keys.
 Set VTBI.
 Set rate.
 Press to save the programming stage.
 Program another infusion stage by following the above method. If no need continue, then press , and
enter the overview interface, in order to check whether each programming stage is correct.
 Press to begin program infusion.
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 Pause stage program

 Move the cursor to corresponding input boxes of time, VTBI and rate with the up or down keys.
 Set time needed to pause.
 Set VTBI to zero.
 Set rate to zero.
 Press .

 Preview and modification of each programming stage


 When no need more program infusion parameters, press to enter the overview interface, check
whether the parameters of each programming stage are correct; if some parameters of certain stage are
found, then move the cursor with the up and down key to the wrong stage, press to correct.

Choose incorrect stage


 After correcting, press to enter the overview interface again.
 Press to start programming infusion.

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Dose/weight mode

 Infusion mode selection

 Press in starting up status, display infusion mode interface.


 Use the up and down keys to choose “weight mode”. Press key.
 Notes:If the present interface is weight mode, can press directly to enter parameters input interface of
weight mode.
 Parameters input in weight mode

 Move the cursor to corresponding input boxes with the up or down keys.
 Dose unit selection. When dose unit flashes, press to choose the dose needed with the up and down
key.
 Input dose value, press or the down key.
 Input weight. Press or the down key.
 Chose drug unit. The box of drug unit flashes, use upward and downward keys to choose unit needed, then
press .
 Input drug amount. First input value, press or down key.
 Input drug concentration (if needed). First input value, then press or down key.
 Input the VTBI. Press .
 Press to begin weight mode infusion.

 Notes:VTBI ≤ DRUG+SOL.VOL

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Drug library mode
The infusion pump WIT-601 with drug library can be exported and imported the drug library through
computer, the operation as follow.
 Import the drug library
Connect the pump with PC by cable and use WIT software to manage the drug library Export & Import

 Export the drug library


Connect the pump with PC by cable and use WIT software to manage the drug library Export & Import

 Infusion mode selection

Mode selection drug selection


 Press in starting up status, display infusion mode interface.
 Choose “Drug—Lib Mode” with up or down key. Press to enter the parameters input interface of drug
mode.

Notes:If the present interface is drug mode, press directly to enter the parameters input interface of drug

mode.

 The operation of known drug concentration

 Dose unit selection. When the box of dose unit flashes, use up and down keys to choose unit press .
 Use up and down keys to move the cursor to corresponding input boxes.
 Input dose rate, press down key.

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 Input drug concentration. Press down key.
 Input weight (if needed). Press down key.
 Input VTBI, Press key.
 Press to begin drug mode infusion.

 The operation of unknown drug concentration

 Drug selection. Use up or down keys to choose drug needed, press .


 At concentration input box, press then the concentration will displayed “N/A”,which means the
unknown drug concentration .
 Input dose rate, then press .
 Input weight (if needed). Press .
 Choose drug unit, then choose the unit with the up or down keys, and press .
 Input drug parameter, press down key.
 Input solution parameter, press down key.
 Input VTBI, Press down key.
 Press to begin drug mode infusion.
Notes:VTBI ≤ DRUG + SOL.VOL

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Chapter 5 Special functions

Bolus

Auto Bolus

Parameters setting of Bolus Bolus


 Press in process of infusion
 Set Bolus rate
 Set Bolus VTBI
 Press to begin Bolus.
 Return to normal infusion after Bolus completed.

Manual Bolus

 Long press in process of infusion.


 Machine would infuse according to the preset Bolus rate.
 Free to stop Bolus infusion.
 Return to normal infusion automatically.

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IV set management

 IV set selection

Infusion set management Infusion set selection Brand selection

Choose infusion set type Exit to main interface


 Press .
 Choose “IV Set” menu, press .
 Choose “Brand” menu, press .
 Choose IV Set brand needed, press .
 Choose IV Set type needed, press .
 Press to exit to main interface.

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 IV set calibration

 Prepare for calibration

Because there is a large size deviation among different brands or different types of infusion set, should
employ 0.9% saline or pure water to calibrate, set the infusion rate to normal infusion rate, like certain
department often employs the infusion rate as 60ml/h-120ml/h, then can take the median 90ml/h as the
calibration rate, so can guarantee the accuracy in the condition of normal infusion after calibration, the
steps for calibration as follows:
1. Hang a bottle or a bag which contains saline or pure water (60ml is suggested);
2. Prepare one electronic balance or measuring cup (if choose electronic balance, should put a vessel
upon), and reset the electronic balance before use.
3. Close the adjustable clamp of infusion set waiting to be calibrated. (make sure no leakage)
4. insert the infusion set waiting to be calibrated into bottle, close the pump door after correct infusion set
installation( make sure the Murphy’s dropper no liquid drips), at the same time open the adjustable
clamp of infusion set;
5. Press to purge the bubbles inside tube, then put the other end of infusion set into the measuring
cup or the vessel;
6. Read the value on the measuring cup or on the electronic balance, then input the value on cue line of the
calibration interface.

 Calibration operation

IV Set management IV Set calibration IV Set calibration

Choose the brand Choose tube type Input favorite rate

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Interface of calibration proceeds Input real output Press confirm key
 Press .
 Choose “IV Set” menu, press .
 Choose “Adjust” , press .
 Choose “Current IV Set” or “Other”, press . (if choose other tube types, complete tube type selection
according to the demands)
 Set frequently-used infusion rate or press directly to take default rate to calibrate.
 Input the value on the measuring cup or on the electronic balance, press .
 Press to exit to main interface.

Notes: 1 、 when the deviation of tube type is larger, machine would judge whether should calibrate again
according to the actual value inputted. Normally after 1-2 times calibration, the accuracy would
meet the requirement of deviation within ±5%.
2、 If alarm prompts in process of calibration, need to re-calibrate according to the steps.
3、 If the brand of infusion set used is not in the brand list of machine, should calibrate to normally use.

 Rapid input calibration

When a batch of machine use the same infusion set to infuse, can calibrate 2-3 machines by using the same
rate, after the calibration, can get the median used to be characteristic value input, and complete calibration
rapidly. The operation as follows:

Long press the up key and input the code Choose the item

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Choose IV Set Input characteristic value and press confirm

 Long press the upward key.


 Input the code, press .
 Input the characteristic value and press to complete calibration.
 Press to exit to calibration interface.

Add IV set
If the brand of tube type actually used is not in the brand list of machine, user can add infusion set brand by
tube type add operation. The operation as follows:

Choose menu Input brand Press confirm to finish


 Choose “IV Set” menu, press .
 Choose “Add Brand” menu, press
 Input brand name through virtual keyboard displayed, press , and prompt brand addition completed.
 If no need to continue to add, press to exit brand addition interface of tube type.

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Remove IV Set
If need to remove needless tube type brands in the tube type list, user can remove infusion set brand through tube
type remove operation. The operation as follows:

Choose menu Choose brand need be deleted Prompt “delete or not” Prompt “deletion completed”
 Choose “Delete brand” menu, press .
 Choose the IV Set brand need to be removed by using up and down keys, press .
 Choose according to the prompt and press to remove brand, otherwise press to exit without
removing.
 If no need to continue to remove, press to exit the brand remove interface of tube type.
Notes:Cannot remove the IV Set in use.

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Chapter 6 General operation

Stop

 Press to stop infusion.

Power off

 Press to stop infusion.


 Press until the screen off.
 Unplug the AC power cord.

Standby

 Press “ ” in stop status, until the screen turns dark.


 Press any key in standby status, and the standby status would be removed.

(Piggyback)

Machine allows to modify the VTBI, Rate, Time, and to reset VI in process of infusion.
 Choose the items need to be modified with up and down keys.
 Input parameters, press .
Notes:1、modify every two of VTBI, rate and time, another one would be calculated automatically.
2、when all these three parameters are changed, machine would calculate and infuse according to the
when last two modified parameters.

Purge

 Press in stop status, until the bubbles are purged totally.


Notes: Purge applies to expel the bubbles inside infusion tube, the infusion needle cannot be connected to
patient when execute purge operation.

Mute

Can suspend the alarm voice by using the Mute key when alarm prompts. The mute lasts 2 minutes, if new
alarm prompts would cancel mute automatically during the mute period, and prompt alarm voice.
 Press mute works, and the mute indicator light lightens.
 Press once again, cancel mute, alarm prompts again, indicator light goes out.

Clear alarm

When alarm prompts, should first exclude alarm reasons to know why alarm prompts.
 Exclude alarm reasons and press .
Notes :1、when AC power is not connected or AC power is interrupted, alarm prompts, can press to
clear alarm, but the AC connection status icon on screen still prompts AC is not connected.
2、if AC power is connected, the alarm will be canceled automatically.
3、the alarm would prompt if there is no other operation when the pause time is up.
4、the pause time can be set to 2min~24h, the default is 2min.
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Clear the VI

 Move the cursor to the VI box, press . The VI is reset.

Battery life check

In process of infusion, can check the runtime of battery under present infusion rate.
 Press .
 Choose “battery life”, press .
 Press to exit.
Notes : Because the runtime of battery depends on the working environment and the aging degree of
battery, there may be a deviation between the runtime checked and the real runtime, so medical staff
should pay attention at any time to the working status of machine when in use without AC
connection. In case of near empty of battery, should dispose in time.

Setting fluid warmer

 Press in progress of infusion.


 Choose the menu of fluid warmer, press .
 Choose the menu of heating range, press .
 Press to return to infusion interface.

Pre-alarm setting of infusion completion

 Press during infusion.


 Choose the menu of infusion completion pre-alarm, press .
 Input the time need be advanced(5~30mins or input 0 to turn off pre-alarm), press .
 Press to return to infusion interface.

Bottom occlusion pre-alarm setup

 Press during infusion


 Choose the menu of bottom pressure pre-alarm, press .
 Choose “ON” or “OFF” pressure pre-alarm, press .
 Press to return to infusion interface.

key lock (auto)

 Press in pause status.


 Choose the menu of system parameters, press .
 Choose the menu of keypad lock setting, press .
 Input the time of automatic keypad lock (input 0 to cancel automatic keypad lock), press .
 Press to return to infusion interface.

key lock (manual)

 Long press key.then the keypad will lock,


- 30 -
 press key again.then the keypad will unlock,

 System parameters setup


 System parameters in pause status
 Press .
 Choose “system parameters”, press .

Sensitivity setting of up  3 level options: high, median and low


occlusion detection  When not easy to prompt occlusion alarm but it please
set to a higher level.
 When easy to occlusion alarm but it prompts in a long
time or it doesn’t prompt, please set to a lower level.
Sensitivity setting of bottom  20 level options: 200-1200mmHg
occlusion detection  When not easy to occlusion alarm but it prompts,
please set to a higher level.

Alarm setting  When easy to occlusion alarm but it prompts in a long


time or it doesn’t prompt, please set to a lower level.

Sensitivity setting of bubble  When big bubble appears but alarm doesn’t prompt,
detection please choose the level of small number.
 When bubble alarm prompt in high frequency, please
choose the level of larger number.

Pre-alarm setting of infusion  Pre-alarm time setting of infusion completed: 5~30min


completed  Can set to no need pre-alarm

Time setting of pause alarm 1min~24h settable

Close fluid warmer Choose not need heat

Fluid warmer 25~30 degrees centigrade 25~30 degrees centigrade


setting 30~35 degrees centigrade 30~35 degrees centigrade

35~40 degrees centigrade 35~40 degrees centigrade

Bolus rate setting  0.1~1200ml/h settable


Bolus setting
 Default 600ml/h

KVO setting KVO rate setting 0.1~20ml/h settable

Manual keypad lock setting  long press keypad lock to lock keypad after setting
Key lock setting Automatic keypad lock time  Lock keypad automatically after 30s~1min settable
setting when infusion begins

Volume setup 3 level options Choose suitable sound volume according to the environment

- 31 -
Time setting Set system time of machine Can input year, month, date; hour, minute, second

Brightness adjustment of Use up and down keys to adjust the brightness


TFT setting
LCD

 System parameters check or setting in process of infusion


 Press .

Sensitivity setting of up  3 level options: high, median and low


occlusion detection  When not easy to prompt occlusion alarm but
Sensitivity setting of up it prompts, lease set to a higher level.
occlusion detection  When easy to prompt occlusion alarm but it
prompts in a long time or it doesn’t prompt,
please set to a lower level.
Sensitivity setting of  20 level options:200-1200mmHg
bottom occlusion detection  When not easy to prompt occlusion alarm but
Sensitivity setting of it prompts, please set to a higher level.
bottom occlusion detection  When easy to prompt occlusion alarm but it
prompts in a long time or it doesn’t prompt,
please set to a lower level.

Sensitivity setting of bubble  When big bubble appears but alarm doesn’t
detection prompt, please choose the level of small number.
Bubble setting  When bubble alarm prompt in high
frequency, please choose the level of larger
number.

Pre-alarm setting of  Pre-alarm time setting of infusion completed:


Pre-alarm setting of
infusion completed 5~30min settable.
infusion completed
 Can set to no need pre-alarm

The pressure of IV set Working with pressure sensor and control by the
goes higher and the pump software
Anti-bolus (Pressure
pump will stop and the
release)
motor will reverse to
reduce the pressure

Close fluid warmer Choose not need heat

25~30 degrees centigrade 25~30 degrees centigrade


Fluid warmer setting
30~35 degrees centigrade 30~35 degrees centigrade

35~40 degrees centigrade 35~40 degrees centigrade

KVO setting KVO rate setting 0.1~20ml/h settable

Battery life check Check battery life Check present battery run time
- 32 -
Chapter 7 History record check
The machine can store as many as 3000 history records. History record allows to be checked in machine or
export to computer.

Check history records in machine

Choose menu Choose item Input date Check results Check results
 Press .
 Choose “ record” menu, press .
 Choose the item need to be checked, press
 Input the date need to be checked, press .
 Choose the item need to be checked, press .
 Press to exit.

Export history record


Connect the pump with PC by cable and use WIT software to manage the history record Export & Import.

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Chapter 8 Security characteristic and alarm

Trouble shooting

Infusion
Alarm message level Possible failure Check and repair
stop
Door open High Yes Pump door is open  Close the pump door and lock.

Infusion set is not properly Properly install the infusion set and make sure it is
installed mounted to the slot of bubble detector

Flick the infusion tube or press Bolus key to purge the


Air inside infusion tube
bubbles
High Yes
Bubble
Inlet blocked Check the infusion inlet

Bubble sensor damaged Replace the sensor

Alarm is not cleared Press the Clear key to cancel the alarm manually.

 Replace new liquid, re-set the volume for


Infusion re-infusion
High KVO Infusion Completed
Completed
 Infusion completed and shutdown.

 Whether need add VTBI


Pre-alarm low NO Pre-complete infusion
 Cancel pre-alarm if not needed

 Check whether the infusion bottle/bag is empty;


Liquid dripping is not
Empty low KVO  Check whether Murphy's dropper is misty or too
detected tilted, liquid flows down along the wall rather
than dripping

Up Occlusion High Yes Infusion inlet is not open  Open the inlet

 Check for strong electromagnetic interference


Abnormal Up pressure sensor is
High Yes around, re-start infusion pump after removal of
up-pressure interfered
the source of interference

Up Pressure Connection of up pressure


High Yes  Contact the manufacturer for maintenance
Sensor Failure sensor looses

 Check whether the infusion tube is folded, and


Tube is folded
unfold it.
Clamp is not open  Open the clamp

 Check whether the infusion tube/needle is


Needle is blocked
High Yes blocked
Down Occlusion
 Check whether for foreign objects are in filter, if
Infusion filter is blocked
any, replace infusion set

Infusion set is too hard or  Replace infusion set or reduce blocking


too thick sensitivity

Pressure Tube is blocked slightly,  Check whether the tube is blocked


low No
Pre-Alarm the pressure going up
 Set pressure level to a higher level

- 34 -
 Can close pressure pre-alarm if not needed

 Check for strong electromagnetic interference


Bottom pressure sensor is
around, re-start infusion pump after removal of
Abnormal down interfered
High Yes the source of interference
pressure
Bottom pressure sensor  Pressure sensor is damaged, contact the
fails manufacturer for maintenance
Down Pressure connection of bottom
High Yes  Contact the manufacturer for maintenance
Sensor Failure pressure sensor looses

IV set non IV set has not been


High Yes  Re-calibrate the IV set according to user’s manual
calibrated calibrated

Tube type setting error


Not re-set the rate  Set correctly the tube type
Abnormal rate High Yes
parameters after replacing  Set correctly the parameters
the tube

Connection of drop sensor


Drop Sensor  Reconnect the sensor
High Yes is off or looses
Failure
Connection is damaged  Contact the manufacturer for maintenance
Abnormal Drop Sensor is not properly  Clip it properly on Murphy’s dropper according
High Yes
Sensor clipped to User’s Manual

 Check the infusion line is installed correctly

Leakage High Yes Infusion tube is skew  Check whether the drip rate sensor is subjected to
strong interference/shaking
 Check whether the door pressing plate is loose

Fluid Warmer Fluid warmer connection  Reconnect heater


High Yes
Failure looses
 Contact the manufacturer for maintenance

Battery Battery power is low and


High Yes cannot be charged  Replace batteries
Failure “ ” normally

Battery off High Yes Battery connection looses  Install the batteries correctly

Low battery
low No Battery power is low  Connect AC supply to charge the battery
flashing)

Motor error High Yes Abnormal motor rotation Contact the manufacturer for maintenance

 Infusion set is not properly installed, so that the


Stepper motor cannot run motor cannot drive the peristaltic pump normally.
Motor Stop High Yes normally
 Infusion pump fails, contact the manufacturer for
maintenance.
Infusion suspended over 2  Press "Clear" key to cancel the alarm and press
Pause Overtime High Yes min "Start" to continue the infusion

AC supply is AC supply is not


low No  Plug the AC supply correctly
interrupted connected correctly

Technical error High Yes Device failure  Contact the manufacturer for maintenance

PS: if there is a single fault, the reason may be the infusion volume is less than 0.7m

- 35 -
- 36 -
Chapter 9 Routine check
 In routine use, please perform routine maintenance and check according to the following
table:
Check
Checkpoints Check procedure
stage
Cracks, broken,  Check whether the housing of WIT-601 series infusion pump is intact, whether
Before use
deformed cracks, broken and deformed exist.

 Boot and do not connect AC, the icon“ ” flashes and accompanies light-sound
AC status and AC
alarm, by this moment connect AC, if the icon appears, the AC supply is boot
alarm
normal, if not, the AC supply is abnormal.
 Correctly install infusion pump and clip infusion set, then boot.
Finger-type
 Press “start” to start infusion. Check whether liquid drops or not, and check In use
peristaltic pump
whether the finger-type peristaltic pump turns abnormally.
 After booting, have not installed IV Set, but “bubble” alarms.
Bubble alarm  Install IV Set with liquid, close door, press “clear”, “bubble” alarm flash should In use
disappear.
 Correctly install infusion pump and clip infusion set, then boot.
Pump door and  Open pump door, door-open alarms, and no liquid drops. Before boot
flow clip  Close pump door and press “clear” key, door-open alarm disappears, and no
liquid drops.
 Correctly install infusion pump and clip infusion set, then boot.
Drop sensor  Start infusion and observe when every liquid drop drops, drop sensor would flash In use
one time.

Abnormal drop  Take out drop sensor in process of infusion, stop infusion, prompting “drop
Periodically
sensor sensor falls off”.

 Correctly install infusion pump and clip infusion set, then boot.
Occlusion alarm  Set infusion rate 100ml/h, occlude manually the bottom infusion set after 5 Periodically
minutes, and then stop infusion after about 1 minute, “down occlusion”
sound-light alarms.

 Correctly install infusion pump and clip infusion set, then boot, purge the bubbles
inside infusion set.
Infusion Set rate to 90ml/h, VTBI to 15ml, start infusion, measure the liquid
 Periodically
accuracy volume flowed out from machine with a measuring cup.
 Check whether the liquid volume flowed out is within 15ml±5%.
note:Carry out the above checks in specified using phase or check stage, if find error, please stop use and contact supplier as soon
as possible.

- 37 -
Chapter 10 Electrical specification

 AC supply
AC supply 100 V - 240 V ~/50-60 Hz Class I

AC power Maximum power 15VA

Fuse of protection 2 x 1A Fuse

 Battery power supply


Battery 9.6V 2000mA –nickel-metal hydride battery
specification

Weight About 150g

Battery runtime More than 4 hours, in condition of infusion rate 25ml/h

Battery Power on:12 h


charging time Power off:10 h

 Communication
Can communication wired or wireless communication

 Certificate of Compliance
Comply with 93/42 / CE medical  IPX4 Degree of Protection
directive (Water) - splash-proof
 Degree of Protection
Comply with EN / IEC 60601 - 1
(Electrical) - Type CF
Medical electronic security equipment and EN / IEC 60601-2-24
standards  Type of Protection
(Electrical) - Class I
Comply with EN / IEC 60601 - 1
EMC(electromagnetic
and EN / IEC 60601-2-24
compatibility)
standards

Comply with EN/2002/95/EC


RoHS Certificate
Revise EN/2011/65/EU directive

- 38 -
Chapter 11 Storage and transport

 Product size, weight


L x Wx H 130 x120x195mm

Weight 2.0Kg

Screen size 3.2 inches

 Storage environment
 Environment temperature: -20℃~55℃;relative humidity:10%~95%;atmospheric pressure:70kPa~
106kPa。
 Forbidden to store in the following environments:
(1)Direct sunlight or strong light.
(2)Direct contact with blowing hot, wet air from heating, electric stove or humidifier.
(3)Chemical storage place or noxious gas place.
(4)Place of Water seepage, splash, dusty or strong vibration.
(5)The floor is not flat.

 Other symbols

:It mean that the machine before use must refer to random file

:It mean that the instrument according to the protection of shock hazard classification is CF type equipment

:It mean that the equipment for spray equipment.

- 39 -
Appendix
 User's Guide and Manufacturer’s Statement of Anti-electromagnetic Interference I

User's Guide and Manufacturer’s Statement of Anti-electromagnetic Interference:


1
apply to all the equipments and systems

WIT-601A Infusion Pump is intended to be used in the following specified electromagnetic environments.
2
Buyers or users should ensure that the pump is used in such environments.

3 Emission test Compliance Guide to electromagnetic environment

WIT-601A Infusion Pump’s RF energy only acts in the


4 RF emission CLSPR 11 Group 1 device. As a result, the RF emission is very low and would
not interfere with nearby electronic equipment.
5 RF emission CLSPR 11 Class B
IEC 61000-3-2
6 Class A
harmonic current
IEC 61000-3-3 voltage
7 Complies
fluctuation and flicker

User's Guide and Manufacturer’s Statement of Anti-electromagnetic Interference: apply to all the
equipments and systems

WIT-601A Infusion Pump is intended to be used in the following specified electromagnetic environments.
Buyers or users should ensure that the pump is used in such environments.

IEC 60601 Guide to electromagnetic


Immunity test Compliance
Test level environment
Wooden, concrete or ceramic tile
Electrostatic flooring preferred. If composite
± 6 kV contact-type ± 6 kV contact-type
discharge (ESD) material flooring is used, the
± 8 kV air-type ± 8 kV air-type
IEC 61000-4-2 relative humidity should not be
less than 30%.
Electrical fast Network power quality should be
± 2kV power cord ± 2kV power cord
transient/burst qualified for typical hospital or
± 1kV input/output ± 1kV input/output
IEC61000-4-4 commercial environments.
± 1kV differential
± 1kV differential Network power quality should be
Surge mode
mode qualified for typical hospital or
IEC 61000-4-5 ± 2kV common
± 2kV common mode commercial environments.
mode

- 40 -
<5%Ut (> 95% drop) <5% Ut (>95% drop)
0.5 cycle 0.5 cycle Network power quality should be
40% Ut (60% drop) 5 40% Ut (60% drop) qualified for typical hospital or
Voltage drop, short
cycles commercial environments. If
circuit and voltage 5 cycles
users need continuous infusion
fluctuations 70% Ut (30% drop) 70% Ut (30% drop)
even during power interruption, it
IEC 61000-4-11 25 cycles 25 cycles is recommended to use UPS or
<5% Ut (>95% drop) <5% Ut (>95% drop) battery.
5 seconds 5 seconds
Power frequency Power frequency magnetic field should
magnetic field be consistent with the standard
3 A/m 3 A/m
(50/60HZ) specification of commercial use or
IEC 61000-4-8 hospitals.

Remarks: Ut is the AC voltage of priority test level


 User’s guide and manufacturer’s statement of anti-electromagnetic interference II

User's Guide and Manufacturer’s Statement of Anti-electromagnetic Interference: applicable for all
non-life-sustaining equipment and systems

WIT-601A Infusion Pump is intended to be used in the following specified electromagnetic environments.
Buyers or users should ensure that the pump is used in such environments.

Immunity test IEC 60601 test levels Complianc Guide to electromagnetic environment
e level
Conducted RF 3Vrms Portable and mobile RF communications device should

IEC 61000-4-6 150KHz to 80MHz 3V not be closer than the recommended separation distance
from any part of WIT-601 Infusion Pump; the distance
shall be calculated using the formula corresponding to the
transmitter frequency.
Radiation, radio 3V/m 3V/m
Recommended separation distance
frequency and 80MHz to 2.5 GHz
electromagnetic
fields
IEC 61000-4-3
80MHz to 800 MHz

800MHz to 2.5 GHz

If p is the maximum rated output power (watts) provided


by RF device manufacturer, then d is the recommended
separation distance (m). (b)

Fixed RF transmitter’s field strength is determined


through electromagnetic site survey; each frequency band
should be lower than the line Compliance level. (a) (b)

The one marked with the following tag would have

interference:
- 41 -
Note 1: if the frequencies of communications device are 80MHz and 800MHz, the formula at a higher
frequency band should be used.
Note 2: this guide may not apply to all situations. Electromagnetic propagation is affected by absorption and
reflection from buildings, objects and human bodies.
a) As to RF transmitters, such as wireless (cordless/cellular) telephones and land mobile radio base stations,
amateur radio, AM/FM radio and television broadcasting, the field strength is unpredictable in theory. To assess
their electromagnetic environments, electromagnetic site survey should be considered; if the measured field
strength at the site of WIT-601A Infusion Pump is higher than RF compliance level, it is necessary to check
whether the pump runs normally. If not, compensation measures may be necessary, such as re-orientation and
positioning for the infusion pump.
b) In the frequency range of 150kHz - 80MHz, the field strength should be less than 3V/m.
Separation distance (m) based on communication equipment
frequency

Max Rated Output Power (W) of 150KHz to 80MHz to 800 MHz to


Communication Equipment 80MHz 800 MHz 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

As to the max rated output power not listed above, the recommended separation distance d (in meters) can be
determined by the formula in frequency column of corresponding transmitters, wherein P is the max rated
output power provided by the transmitter manufacturer (watts).
Note 1: if the frequencies of communications device are 80MHz and 800MHz, the formula at a higher
frequency band should be used.
Note 2: this guide may not apply to all situations. Electromagnetic propagation is affected by absorption and
reflection from buildings, objects and human bodies.
Recommended separation distance between portable/mobile RF communications device and infusion pump
WIT-601A Infusion Pump is intended to be used in the electromagnetic environment with control of radiated
RF disturbance. According to the max output power of communications device, buyers or users can prevent
electromagnetic interference by maintaining the minimum distance between portable/mobile RF
communications device (transmitters) and the infusion pump.

- 42 -
 Infusion accuracy characteristic
Horn-shaped curve represents the changes of maximum and minimum bias in infusion pump. The testing
programs for these results have been included in EN60601-2-24 (IV set Drag Heart 20 drops/ml standard
PVC set). The following graphs and curves show the overall characteristics of the infusion pump in tests. For
more information, please contact the supplier.

- 43 -
 System statement
WIT – 601 can be attached to other medical electronic equipments, the person who composes this medical

electronic system should be responsible for the requirement of compliance.

The equipments connected with WIT – 601 should comply with their respective IEC or ISO standards (i.e.

information processing equipment IEC60950), and the whole equipment should comply with the requirement of

medical equipment system (see IEC60601-1-1 or IEC60601-1 Chapter 16 Version 3).

If you have doubts, please consult your local representative or technical support department.

- 44 -
Product and service information
Product name: Infusion Pump
Model: WIT-601A
Product standard: EN/IEC 60601-1, 60601-2-24
EN/IEC 60601-1-2, 60601-1-8
Manufacturer: Guangzhou WIT Medical Technology Co.,Ltd
Address: Unit 1103, Area C3, Innovation Building, No.182 Science Road, Science City, High-tech Industrial
Development Zone, Guangzhou,China.
Tel:+86-20-82118816/82118829
Fax:+86- 20-82118966
Web: http://www.witmedical.com
Email: sales@witmedical.com

EC-Representative: CMC Medical Devices & Drugs S.L.


Address: C/ Horacio Lengo Nº18, CP 29006, Málaga, Spain
Tel: +34 951214054
Email: info@cmcmedicaldevices.com

Distributor By:

- 45 -

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