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User Manual of Infusion Pump WIT-601A
User Manual of Infusion Pump WIT-601A
User Manual
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 -
-1-
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 -
-2-
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.
-3-
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
-4-
Chapter 1 Overview
IV Set Options /Size: Open System for common widely-used brand of 10d/ml、15d/ml、20d/ml、60d/ml
Rate/VTBI、Time/VTBI、Rate/Time、Volume、Drop、Micro、Simple Rate、
Working Mode
Programmable、DOSE Weight、Drug Lab、Auto Bolus、Manual Bolus.
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
-5-
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,
Use Range For the patients with constant intravenous infusion of drugs
-6-
Chapter 2 Components description
Handle
LCD
Fluid warmer
Key
Drop sensor
Door latch
Up pressure
Bubble sensor
Peristaltic pump
Roller clamp
-7-
Main information displayed on LCD
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.
-8-
Infusion pump structure
Figure 4
-9-
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
- 10 -
Vertical installation on bracket
Installation on cylinder
- 11 -
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.
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
- 12 -
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
- 13 -
Chapter 4 Operation
Function keys concentrate upon the front housing, operated easily, the functions are as follows:
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.
Figure 11
- 14 -
Operation Flowchart
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.
- 15 -
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.
- 16 -
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.
- 17 -
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.
VTBI/Rate Setting
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 .
- 19 -
Dose/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
- 20 -
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
Notes:If the present interface is drug mode, press directly to enter the parameters input interface of drug
mode.
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.
- 21 -
Input drug concentration. Press down key.
Input weight (if needed). Press down key.
Input VTBI, Press key.
Press to begin drug mode infusion.
- 22 -
Chapter 5 Special functions
Bolus
Auto Bolus
Manual Bolus
- 23 -
IV set management
IV set selection
- 24 -
IV set 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
- 25 -
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.
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
- 26 -
Choose IV Set Input characteristic value and press confirm
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:
- 27 -
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.
- 28 -
Chapter 6 General operation
Stop
Power off
Standby
(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
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.
- 29 -
Clear the VI
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.
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.
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
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.
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
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.
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.
- 33 -
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
Alarm is not cleared Press the Clear key to cancel the alarm manually.
Up Occlusion High Yes Infusion inlet is not open Open the inlet
- 34 -
Can close pressure pre-alarm if not needed
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
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
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
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
- 38 -
Chapter 11 Storage and transport
Weight 2.0Kg
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
- 39 -
Appendix
User's Guide and Manufacturer’s Statement of Anti-electromagnetic Interference I
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.
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.
- 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.
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
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
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.
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System statement
WIT – 601 can be attached to other medical electronic equipments, the person who composes this medical
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
If you have doubts, please consult your local representative or technical support department.
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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
Distributor By:
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